Patent Application
20250049574
The present invention relates to connection technology for composite materials, and in particular to applications in medical devices, providing a connected structure for porous structures and substrates and a method for making the same, which can be provided with sensors or drugs as desired; the invention also provides methods and prostheses for using said connected structure.
Engineering applications often have different requirements for the overall performance and surface properties of mechanical structures. For example, the overall performance (e.g., fatigue strength) of the acetabular cup and femoral stem of an artificial hip joint must meet the fatigue resistance requirements of the prosthetic implant under the dynamic loads that it will endure during an average of one to two million walking cycles per year for decades after implantation, and there are specific performance needs for the surface of the prosthetic implant to meet so that the surface of the prosthetic implant may be firmly bonded to the patient's bone structure to ensure that the prosthetic implant does not fail due to loosening; otherwise, the patient will have pain and the prosthetic implant must be removed, which means that the patient needs to undergo a revision surgery to implant a new prosthetic implant.
Similar situations and needs exist for other orthopedic implants (e.g., spine). In fact, in other fields, there are situations where the substrate and the surface have different performance needs and a reliable and effective connection between the two is required.
Commonly used materials for joint prostheses are titanium alloy/cobalt-chromium alloy/stainless steel, etc., which do not form an effective biological or chemical bond with bone. The interface between the prosthetic implant and the bone is primarily through physical/mechanical interlocking. For example, a highly polished prosthetic surface and bone tissue cannot form an effective bond. Therefore, existing technologies can create a rough surface on the prosthetic surface by sandblasting, plasma spraying titanium, etc. to increase the interfacial friction between the prosthetic implant and bone tissue and to help enhance the physical/mechanical fixation of the prosthetic implant-bone interface. In the field of orthopedics, this is referred to as a “bone ongrowth” surface. In some cases, materials such as hydroxyapatite (or add-ons that can incorporate growth factors, stem cells, etc.) can be used as a coating over the rough surface of the prosthetic implant to increase osteoconductivity, osteoinduction, and bone regeneration to accelerate or enhance the connection of bone tissue to the surface of the prosthetic implant, further enhancing the “bone ongrowth” performance.
In addition, sometimes titanium wires or titanium beads, etc. can be used to form a porous coating on the surface of the prosthetic implant (e.g., acetabular cup/femoral stem) using methods such as sintering or diffusion bonding. Alternatively, a thin sheet 0001 with a porous structure is prefabricated using metal 3D printing additive manufacturing processes, vapor phase deposition processes, etc., and then the sheet 0001 is bonded to the solid substrate 0002 of the prosthetic implant through diffusion bonding, as shown in
Relatively speaking, the laser welding process has a lower influence on the mechanical properties of the substrate. However, when the porosity of porous structures is high (>50%), the interconnected scaffolds are few in numbers and weak in strength; a large number of pores are formed between the scaffolds. Such a highly porous structure, whether achieved by 3D printing additive manufacturing process or other processes such as sintering, when the direct laser welding is used to connect the porous structure and the substrate, and the effective diameter of the laser beam is close to or even greater than the width of the scaffold, the laser energy may directly break the scaffolds, hence destroy the porous structure and can not achieve effective welding of the porous structure and the substrate. Alternatively, when diffusion bonding is used to connect the porous structure to the substrate, the strength of the substrate structure is significantly reduced due to the high temperature and elevated pressure of the process.
On the other hand, periprosthetic infection is a catastrophic complication of joint arthroplasty and a major cause of revision after joint arthroplasty. It is very difficult to diagnose and treat, often requiring multiple surgeries and long courses of anti-infective treatment, with high complications, long hospital stays, and expensive treatment. The occurrence of periprosthetic infection is the result of the interaction between pathogenic bacteria, the prosthetic implant and the human body. Based on the duration of symptoms, infection can be divided into: acute infection (less than 3 months), delayed infection (3 to 12 months), and chronic infection (more than 12 months). Acute and delayed infections are mostly caused by intraoperative contamination or postoperative wound complications resulting in pathogenic bacteria invasion, while chronic infections are mostly caused by the entry of pathogenic bacteria from distant initial foci of infection into the bloodstream causing bacteremia and dissemination to the affected joints via the blood circulation, making their prevention and treatment particularly difficult.
The present invention provides porous composite connected structures, methods and prostheses with sensor detection and drug placement. The said porous composite connected structure is an effective connected structure of a porous structure and a substrate, which can largely maintain the mechanical properties of the substrate and meet the overall requirements and the surface properties at the same time, and is suitable for prosthetic implants. The connected structure can be provided with sensors or drugs as needed. The present invention also provides prosthetic implant and method for applying the said connected structure.
A technical solution of the present invention is to provide a connected structure of a porous structure and a substrate; said connected structure, comprising: a composite, comprising a first porous structure pre-connected or integrally formed with an intermediate, said intermediate having a higher solid volume fraction than the first porous structure; a substrate, which is connected to the first porous structure and/or the intermediate of the composite; said connected structure is provided with at least one holding space for holding drugs and/or sensors.
Preferably, said intermediate comprises an insertion portion and/or an interlayer; said insertion portion having at least a portion of structure disposed within the first porous structure; said interlayer having at least a portion of structure disposed between the first porous structure and the substrate.
Preferably, said intermediate is a solid structure, or a second porous structure; said second porous structure having a higher solid volume fraction than said first porous structure.
Preferably, said substrate is a solid structure, or a third porous structure; said third porous structure having a higher solid volume fraction than said first porous structure.
Preferably, the solid volume fraction of said second porous structure is between that of said first porous structure and that of said third porous structure.
Preferably, said substrate is made by forging or casting or machining or powder metallurgy or metal powder injection molding.
Preferably, said first porous structure of the composite, together with the intermediate, is integrally formed by a 3D printing additive manufacturing process, or a vapor phase precipitation process, or a sintering process.
Preferably, said substrate is metallic; said first porous structure is metallic; and said intermediate is metallic.
Preferably, the channel or opening of the holding space, is directly or indirectly connected to an open space outside said connected structure; or, to other holding spaces of the connected structure.
Preferably, the channel or opening of the holding space is connected to the external open space through channels or openings of single or multiple components comprising a first porous structure, an intermediate, a substrate, an additional substructure of the connected structure.
Preferably, the channel or opening of the holding space is connected to other holding spaces through channels or openings of single or multiple components comprising a first porous structure, an intermediate, a substrate, an additional substructure of the connected structure.
Preferably, said channel or opening of said holding space, directly or indirectly connected to an exposed surface of said connected structure, said exposed surface being exposed to an external open space; with one or more of the following components having said exposed surface; and said components comprising a first porous structure, an intermediate, a substrate, an additional component of the connected structure.
Preferably, one or more of the following components contain channels or openings serving as or connecting with those of the said holding spaces; the said components comprising: a first porous structure, an insertion portion, an intermediate, a substrate, an additional component of the connected structure.
Preferably, said channel or opening of said holding space is open, or closed and to be subsequently opened, or, closed and then no longer to be opened.
Preferably, the holding space for holding the drug, is the same or a different holding space as that for holding the sensors.
Preferably, the channels or openings of the holding space for placing the drug are provided for the delivery of the drug.
Preferably, when the holding space for the drug is provided with openings/channels, the said openings/channels comprise an input port/channel and an output port/channel for the drug; said input and output ports/channels being different openings/channels or the same opening/channel; Preferably, the said output port of the drug is an open orifice for controlled release, or an orifice closed by a controlled-release plug; and the said input port of the drug is an injection orifice closed by a plug for injection, or an open injection orifice.
Preferably, an external detection device can be used to detect and locate the input channel or input port for the drug, or the channel or opening connected with the input channel or input port.
Preferably, the external detection device uses radiation or ultrasound for detection.
Preferably, the plug for the channel or port is made of any of the following materials; a material that can self-trigger to open up in response to a change in the surrounding environment; a material that can trigger to open up in reaction with a set substance; a material that can degrade over a set period; a material that can dissolve; a material that can allow drugs to pass through; a material that can slowly release drugs.
Preferably, the drug form when placed into the holding space and that when released from the holding space are the same, or different.
Preferably, said drug is liquid, or solid object, or gas when placed into the holding space; and the said drug is liquid, or solid object, or gas when output from the holding space.
Preferably, said connected structure is subjected to a change in the state of the environment to which the drug is subjected, causing a transformation in the form of the drug.
Preferably, said drug reacts with the set substance to transform the form of the drug.
Preferably, the transformed drug is released from the holding space.
Preferably, said drug is encapsulated with any of the following materials; a material that can self-trigger to open up in response to a change in the surrounding environment; a material that can trigger to open up in reaction with a set substance; a material that can degrade over a set period; a material that can dissolve; a material that can allow drugs to pass through; a material that can slowly release drugs.
Preferably, said sensor detects at least one state inside or outside of the said connected structure; or, the said sensor detects a set substance.
Preferably, said sensor detects the temperature, or the pressure, or the humidity of the environment in which the connected structure is located.
Preferably, said sensor detects a set substance, including bacterial strains.
Preferably, said set substance is purposefully placed into the connected structure; or, spontaneously formed within the surrounding environment of the connected structure.
Preferably, said set substance is input from an open space outside the connected structure or from other holding spaces of the connected structure, directly or indirectly, to the holding space for placing the drug and/or to the sensor holding space.
Preferably, said set substance is input through an exposed surface of the connected structure and thus into a holding space directly or indirectly connected to said exposed surface.
Preferably, said set substance is input into the holding space for placing drugs and/or sensors, via channels or ports provided by one or more of the following components, comprising a first porous structure, an insertion section, an intermediate structure, a substrate, or an additional sub-structure of the connected structure.
Preferably, said set substance is input into the holding space prior to, or subsequent to, or simultaneously with the input of the drug.
Preferably, said set substance is water, or another drug.
Preferably, the sensor holding space is provided with a channel or opening for placing the sensor into the holding space.
Preferably, the sensor holding space is provided with a channel or opening, the sensor being provided with an antenna transmitting information or electrical energy in a wireless manner, said antenna being within the holding space and facing said channel or opening, or extending into the outside of the holding space through said channel or opening.
Preferably, the sensor holding space is provided with a channel or opening, the sensor is provided with a probe for detection, said probe being within the holding space and facing said channel or opening, or extending to the outside of the holding space through said channel or opening.
Preferably, said sensor is provided with detection probes or detection surfaces, which are exposed to the outside of the connected structure or are facing channels or openings connected to the exposed surface of the connected structure.
Preferably, devices charging the sensors are provided in the sensor holding space or other holding spaces within the connected structure or provided outside of the connected structure; said charging devices supplying power to the sensors by wired or wireless means.
Preferably, said sensor transmits electrical energy and/or information with other devices via wires; said other connected devices being located in the sensor holding space or other holding spaces of the connected structure, or outside of the connected structure.
Preferably, the channels or openings of the sensor holding space are used for wiring; and the channels or openings of the following components are used for wiring, which are connected to the sensor holding space; the said components including a first porous structure, an intermediate, a substrate, and additional components of the connected structures.
Preferably, the receiving coil of the wireless charging module cooperates with the external feeding coil to obtain electrical energy wirelessly, and the electrical energy is converted, processed and supplied to the sensors or other electrical components or electrical energy storage elements.
Preferably, the device for charging the sensors or other electrical components of the connected structure, including electrical energy storage elements; said electrical energy storage elements obtaining electrical energy from an external source by wired or wireless means; said electrical energy storage elements provide electrical power by wired or wireless means.
Preferably, the electromagnetic signal trigger switch receives a magnetically induced signal corresponding to an external command and converts it to a corresponding electrical signal to control the sensor or other controlled components of the connected structure; the said electromagnetic signal trigger switch being provided in the holding space where the sensors or other controlled devices are located or in another holding space where there is no sensor or other controlled device; said electromagnetic signal trigger switch providing the converted electrical signal to the sensors or other controlled devices by wired or wireless means.
Preferably, said sensor is paired with a processor for signal transmission and analyses, with the said processor being used to analyze the detection data; said processor and sensor are integrated or both are independent and achieve signal transmission by wireless or wired means; said processor is provided in the sensor holding space or other holding spaces or outside the connected structure.
Preferably, said connected structure is provided with a trigger device, which acts upon the closure bodies plug, or the drug capsule, or opens the drug input or output channel/port by applying a set substance, or by changing the surrounding environment of the connected structure; said trigger device is engaged upon receiving, by wired or wireless means, instructions from sensors, processor, electromagnetic signal trigger switch, external devices, timer, or timing devices.
Preferably, said drug is timed for controlled release at scheduled time points or time intervals.
Preferably, said triggering device is for single-use or multiple-uses.
Preferably, said sensor is driven to detect at set time schedule according to instructions from a timer or a timing device; said sensor performs detection at defined time points or time intervals.
Preferably, said holding space has no edge interface along external boundary of the connected structure; or, has edge interfaces in at least some directions.
Preferably, said edge interface of said holding space is either closed or not closed.
Preferably, that said edge interface of the holding space is formed by a first porous structure or an intermediate or a part of the substrate adjacent to the holding space, or an additional sub-structure of the connected structure.
Preferably, the holding space contains one or more, or none of the following components: a first porous structure, or an intermediate, or a substrate, or an additional sub-structure of the connected structure.
Preferably, components on one or multiple sides around the holding space, individually or cooperatively, secure the solid object; the said components of the connected structure comprise of one or more of the following: a first porous structure, an intermediate, a substrate, an additional component of the connected structure; and said solid object comprises of one or more of the following: a solid object of the contained substance, an encapsulated object of the contained substance, an object formed by edge interfaces of the holding space.
Preferably, a solid object formed directly by the drug itself is directly secured with corresponding components of the connected structure; or, the encapsulated drug is placed into the holding space or secured by corresponding components of the connected structure; or, the solid object or non-solid object formed by the drug itself is placed within a holding space with solid object edge interfaces on at least one side.
Preferably, the sensors are directly secured by corresponding components of the connected structure; or, the sensors are enclosed in a solid object enclosure bodies, which is then placed into the holding space or secured by corresponding components of the connected structure; or, the sensors are placed in the holding space with a solid object edge interface on at least one side.
Preferably, securing the solid object includes loading the solid object: said components support the solid object from one or multiple directions, either individually or cooperatively; said components carry the load through structural parts adjacent to the holding space or those extended into the confinement of the holding space.
Preferably, securing the solid object includes a tight fit to the solid object: said components are in close contact with the solid object from at least two opposite directions; said components achieve tight fit through structural parts adjacent to the holding space or those extended into the confinement of the holding space; through structural parts adjacent to the holding space or those extended into the confinement of the holding space; and the tight fit to the solid object is achieved by different parts of the same component, or different components.
Preferably, securing the solid object includes position-limiting the solid object: said components individually or cooperatively form a position-limiting structure located in at least one direction of the solid object, preventing the solid object located on one side of the position-limiting structure from moving to the other side; said position-limiting structure includes position-limiting protrusions.
Preferably, securing the solid object includes position-limiting the solid object: said components individually or cooperatively form a position-limiting structure in close contact with the solid object from at least one direction; said position-limiting structure includes at least one position-limiting protrusion, formed at a location on the said component adjacent to the holding space and extending into the confinements of the holding space.
Preferably, the part of said solid object corresponding to the position-limiting protrusion is provided with a position-limiting recess matching the position-limiting protrusion so that said position-limiting protrusion can be set into the position-limiting recess; alternatively, the part of said solid object has no position-limiting recess corresponding to the position-limiting protrusion.
Preferably, when the component position-limiting the solid object comprises a first porous structure, said position-limiting protrusion comprises the ends of a portion of the struts of the first porous structure; which are adjacent to the holding space and their ends may extend into the confinements of the holding space.
Preferably, securing the solid object comprises position-limiting the solid object: said component individually or cooperatively forming a position-limiting structure in close contact with the solid object from at least one direction; said position-limiting structure comprising matching position-limiting protrusions and position-limiting recess, said position-limiting recess being formed at said parts adjacent to the holding space, said position-limiting protrusions being set on the surface of the solid object and extending into the confinements of the holding space, with the said position-limiting protrusions being set in the said position-limiting recess.
Preferably, when the component position-limiting the solid object comprises a first porous structure, said position-limiting recess comprises a portion of the pores of the first porous structure adjacent to the holding space; this portion of the pores retains the form it had when the first porous structure was made, or by machining this portion of the pores of the first porous structure to form said position-limiting recess.
Preferably, after the composite is connected to the substrate, a part of the connected structure is removed to form at least a part of the holding space, or to form a channel or opening in the holding space; the removed part comprises one or more of the following: a part of the first porous structure, at least a part of the insertion, a part of the intermediate, a part of the substrate, at least a part of the additional components of the connected structure.
Preferably, the removed part is used as a closure bodies plug to subsequently close said channel or opening.
Preferably, the closure bodies that closes the channel or opening of the holding space is formed by the first porous structure or intermediate or part of the substrate adjacent to the holding space, or by an additional component of the connected structure.
Preferably, at least a portion of the intermediate, at a predetermined position of the connected structure, is adjacent to the holding space and serves as a channel or opening of the holding space; after the contained substance is placed into the holding space, that portion of the intermediate is mounted to the predetermined position to achieve closure bodies of the channel or opening.
Preferably, the additional components of the connected structure, includes a component which is used to form the holding space by acting as at least a part of the edge interface of the holding space or forms a closure bodies for closing the channel or opening of the holding space; said component being used to form the holding space by connecting with parts of the first porous structure or intermediate or substrate at locations adjacent to the holding space, or connected with other components of the connected structure.
Preferably, the additional component of the connected structure comprises a filling body which connects a portion of the struts of the first porous structure adjacent to the holding space to form a filling surface; said filling surface acting as at least a portion of the edge interface of the holding space, or forming a closure bodies for closing a channel or opening in the holding space; said filling surface being separately provided at the first porous structure or coupled to an intermediate or substrate or other components of the connected structure.
Preferably, a substance in molten form, after solidification at a designated part of the connected structure, serves as at least a portion of the edge interface of the holding space, or forms a closure bodies for closing a channel or opening in the holding space, or for coupling part a portion of the struts of the first porous structure; the substance is a polymeric material, or a material identical or similar in nature to the first porous structure or intermediate or substrate.
Preferably, the molten substance is injected into the designated part of the first porous structure and then waits for it to solidify; or, the raw material of the substance is placed in the designated position, at least the vicinity of the designated position is heated so that the raw material of the substance becomes molten and fills the pores of the first porous structure around the designated position.
Preferably, the closure bodies for closing the channel or opening is made of any of the following materials: a material identical to the first porous structure or intermediate or substrate; a material having properties similar to the first porous structure or intermediate or substrate.
Preferably, similar properties mean similar electrical conductivities, or similar solid volume fractions.
Preferably, the closure bodies for closing the channel or opening is a solid structure or a porous structure with the same or different solid volume fraction as the first porous structure.
Preferably, all or part of said holding space is formed within the first porous structure; at least part of the surface of said first porous structure is an exposed external surface of said connected structure.
Preferably, a portion of said holding space is formed at or within the first porous structure and other portions of the holding space are formed at or within one or more of the following components; said components comprising an intermediate, a substrate, an additional component of the connected structure.
Preferably, the recess formed at the first porous structure serves as at least a part of the holding space.
Preferably, said recess is formed on an exposed surface of the first porous structure.
Preferably, a specific pore or a plurality of interconnected pores within the first porous structure serves as at least a portion of the holding space.
Preferably, the first porous structure or intermediate or the substrate is formed with recessed or through structures at locations adjacent to the holding space such that a portion of the holding space extends into these structures.
Preferably, a portion of the pores of said first porous structure, serve as channels or openings for holding spaces, or are connected to channels or openings for holding spaces, or are connected to external open spaces, or are connected to channels or openings provided by one or more of the following components: an intermediate, a substrate, an additional component of the connected structure.
Preferably, said channel provided at the substrate, is connected to a channel or opening in the holding space, or to an external open space, or to a channel or opening provided by one or more of the following components: an intermediate, a substrate, an additional component of the connected structure; said channel provided at the substrate, being a duct formed inside the substrate; or, said channel provided at the substrate is a groove which is formed on the surface of the substrate near the side of the composite, and which is open at least partially in the direction in which the composite is located.
Preferably, the interlayer portion between the composite and the substrate, comprises raised structures and/or an intermediate body; said interlayer portion has the following positional relationship with the holding space (a1 and/or a2):
Preferably, when said part within or adjacent to the holding space contains raised structures without the intermediate body, said raised structures alone, or in conjunction with one or more of the following components located within or adjacent to the holding space to achieve fixation: a first porous structure, other raised structures, an insertion into the intermediate, an additional component of the connected structure, and a substrate.
Preferably, when said part within the holding space contains raised structures without an intermediate body, said composite body further comprises an extension part, a part of which is connected to raised structures and extends into the holding space; another part of the extension part is connected to one or more of the following parts adjacent to the holding space or outside the holding space: a first porous structure, other raised structures, an insertion portion of an intermediate, an additional component of the connected structure, a substrate.
Preferably, the gaps between adjacent raised structures serve as channels or openings for holding spaces, or are connected to channels or openings for holding spaces, or are connected to external open spaces, or are connected to channels or openings provided by one or more of the following components: the first porous structure, other interlayers of the intermediate, the insertion portions of the intermediate, the substrate, the additional component of the connected structure.
Preferably, said gaps between the raised structures and the substrate serve as channels or openings for the holding space, or are connected to channels or openings for the holding space, or connected to an external open space, or connected to channels or openings provided by one or more of the following components: a first porous structure, other interlayer portions of the intermediate, an inserted portion of the intermediate, the substrate, the additional component of the connected structure.
Preferably, said intermediate body is in the form of a layer, or a sheet, or a plate.
Preferably, the part of said intermediate body located within the holding space, alone, or in conjunction with one or more of the following components to secure the solid object within the holding space: the first porous structure, other parts of the intermediate body, other interlayer parts other than the intermediate body, the insertion portion of the intermediate, an additional component of the connected structure, the substrate.
Preferably, the part of said intermediate body located within the holding space acts as at least a part of the edge interface of the holding space.
Preferably, the part of said intermediate body located within the holding space contains openings to secure the solid object set in the openings.
Preferably, said the part of said intermediate body located within the holding space contains openings, acting as channels or openings of the holding space, or are connected to channels or openings of the holding space, or to an external open space, or to channels or openings provided by one or more of the following components: a first porous structure, other parts of the intermediate body, the interlayer other than the intermediate body, the insertion portion of the intermediate, the additional component of the connected structure, the substrate.
Preferably, the part of said intermediate body located within the holding space contains openings and an extension part is provided on the inside of the openings; the solid object being secured by the extension part.
Preferably, said intermediate body is closed; or, said intermediate body is provided with channels or openings.
Preferably, said channels provided to the intermediate body are formed in the interior of the intermediate body; or, said channel provided to the intermediate body are grooves formed on the surface of the intermediate body near the side of the substrate, and at least a portion of the groove are facing towards the substrate.
Preferably, said intermediate body is provided with a first groove as a channel for the intermediate body, and/or, said substrate is provided with a second groove at said substrate as a channel for the substrate;
Preferably, when the composite is resistance welded to the substrate, the weld interface of the composite comprises a first porous structure and/or an intermediate body, without raised structures that projects toward the substrate; or, the weld interface of the composite comprises one or more of the first porous structure, the intermediate body, and raised structures that projects toward the substrate.
Preferably, when the composite body is resistance welded to the substrate, said weld interface of the substrate is provided with a substrate raised structure, which project towards the weld interface of the composite body; said substrate is connected to the weld interface of the composite body at least through the substrate raised structures; and, connected to said substrate raised structures, is a weld interface of the composite body on the first porous structure of the composite body, or an interlayer not containing raised structures, or a part of the interlayer at which no raised structure is provided.
Preferably, said connected structure comprises a support part, at least a portion of which is inserted into the first porous structure;
Preferably, said support part passes through the solid object in order to secure it; the part of the solid object that is not secured by the support part is secured by one or more of the following components, or is not in contact with said components; said components, comprising: other support parts, a first porous structure, an insertion of the intermediate, an interlayer of the intermediate, a substrate, additional components of the connected structure.
Preferably, said holding space is formed, in whole or in part, within the support part.
Preferably, all or part of the surfaces of the support part serve as at least part of the edge interface of the holding space.
Preferably, gaps or openings existing or created in the support part serve as at least part of the holding space; or, is used for securing the solid object; or, is used to place the parts to secure the solid object.
Preferably, the gaps between adjacent support parts, and/or the channels or openings placed at the support parts, serve as channels or openings of the holding spaces, or are connected to channels or openings of the holding spaces, or are connected to external open spaces, or are connected to channels or openings of one or more of the following components: a first porous structure, an interlayer of intermediates, the insertion portion of the intermediate, the substrate, and additional component of the connected structure.
Preferably, after the composite body has been connected with the substrate, the gaps formed subsequent to the removal of all or parts of the support parts becomes at least a part of the holding space.
Preferably, the solid object is provided with an insertion structure, which is inserted to the gaps of the said porous structure to secure the fixation of the solid object.
Preferably, the solid object is provided with an insertion structure, said insertion structure being inserted to a gap formed within the first porous structure at a location corresponding to the insertion site of the support part; the gap is formed by removing all or part of the support part after the composite is connected to the substrate; alternatively, the gap is located between the support part and the first porous structure surrounding the insertion site thereof.
Preferably, the solid object is secured at the support part by means of a hoop structure provided.
Preferably, the solid object is provided with an integrated insertion and hoop structure; the insertion structure of the solid object is inserted at a gap formed within the first porous structure corresponding to the insertion site of the support part, and the hoop structure is fixed to the support part within the said gap.
Preferably, said hoop structure is a closed-hoop structure over the support part; alternatively, said hoop structure is an open-hoop structure in close contact with the support part.
Preferably, the solid object is provided with an insertion structure, said insertion structure being inserted at a gap set in the support part; or, the solid object is provided with an insertion structure, said insertion structure being inserted at a recess set in the support part.
Preferably, a recess is formed at said support part, at which the electrode segment is inserted for connecting the composite body with the substrate; after the composite body is connected to the substrate, the insertion structure of the solid object is inserted into said recess; or, said recess is used as at least part of the holding space.
Preferably, the position into which the insertion structure of the solid object is inserted corresponds to the first end of the insertion site of the support part; the solid object is in contact or not in contact with the surface of the first side of the first porous structure; or, the position into which the insertion structure of the solid object is inserted corresponds to locations other than the first end of the insertion site of the support part, with such locations being adjacent to the holding space; wherein, when the insertion structure is inserted, the first end or other parts of the support part are still present at the insertion area, or have been removed.
Preferably, the position at which the hoop structure of the solid object is fixed corresponds to the first end of the support part insertion site; the solid object is in contact or not in contact with the first side surface of the first porous structure; or, the position at which the hoop structure is fixed corresponds to a part of the support part insertion site other than the first end, which is adjacent to the holding space.
Preferably, the gap corresponding to the insertion site of the support part within the first porous structure, serves as a holding space, or as a channel or opening, or is used to provide other components for securing the solid object;
Preferably, prior to the connection of the composite body to the substrate, the support part is in direct contact with the first porous structure around its insertion site; after connecting the composite body with the substrate, all or parts of the support part are removed to form a gap corresponding to the insertion site.
Preferably, prior to the connection of the composite body to the substrate, the support part is not in direct contact with the first porous structure around its insertion site, and, said support part being inserted at the first gap formed within the first porous structure; the support part is separated from the surrounding first porous structure by the said first gap; after the connecting the composite body with the substrate, the space created by removing all or part of the support part is linked to the first gap, forming a gap corresponding to the insertion site.
Preferably, prior to the connection of the composite body to the substrate, the support part is not in direct contact with the first porous structure around its insertion site, and, said support part being inserted at the first gap formed within the first porous structure; the support part is separated from the surrounding first porous structure by the said first gap; after the connecting the composite body with the substrate, keep the support part, and use the said first gap as the gap corresponding to the insertion site.
Preferably, at the time of connection of the composite body to the substrate, an insulator is provided in the interval of the first gap, separating the support part from the surrounding first porous structure; after connection of the composite body to the substrate, the insulator is removed in whole or in part to form a gap corresponding to the insertion site, or to form an interval connected to said gap.
Preferably, after the composite body is connected to the substrate, the first porous structure around the insertion site remains the same as before the connection of the composite body to the substrate, or is partially removed to form a gap corresponding to the insertion site, or is partially removed to form a space linked to said gap.
Preferably, after the composite body is connected to the substrate, the first end of the support part does not extend beyond the first side surface of the first porous structure, the gap corresponding to the insertion site comprises the gap located between the first end of the support part and the first side surface of the first porous structure; after the composite body is connected to the substrate, the first end of the support part extends beyond or is flush with the first side surface of the first porous structure, then the gap corresponding to the insertion site comprises the gap between the insertion site of the support part and the surrounding first porous structure.
Preferably, the component provided for securing the solid object at the gap corresponding to the insertion site comprises an insertion structure and/or a hoop structure of the solid object; said insertion structure is inserted in the gap and said hoop structure is secured to the support part.
Preferably, after the composite body is connected to the substrate, the first end of the support part extends beyond the first side surface of the first porous structure as an extended portion of the support part; the solid object insertion structure and/or the hoop structure are provided at the extended portion of the support part.
Preferably, the second end of the support part does not extend beyond or is flush with the second side surface of the first porous structure; when the second end of the support part is flush with said second side surface, the intermediate contains an interlayer portion that is or is not in contact with the second end of the support part; When the second end of the support part is flush with said second side surface and the intermediate does not contain an interlayer portion, the second end of the support part is or is not connected to the substrate.
Preferably, the support part is in contact with the side of the interlayer's intermediate body distal to the substrate, the side of the intermediate body proximal to the substrate being provided with or without raised structures;
Preferably, the support part is in direct contact with the raised structures of the interlayer arranged in corresponding locations; or, alternatively, the support part is staggered with the raised structures of the interlayer and is not in direct contact with each other;
Preferably, said support part is made of an insulating material; alternatively, said support part is made of a conductive material and is the insertion portion of the intermediate.
Preferably, said support part is made of a molten substance solidified after injection into the first porous structure; the substance being a polymeric material or a material of the same or similar nature as the first porous structure or intermediate or substrate.
Preferably, said support part is a solid structure; or, said support part is a porous structure with its solid volume fraction higher than that of the first porous structure.
Preferably, said support part is provided with a coupling part and/or an extension part, and serves as at least part of an edge interface, or as a closure bodies to close the channel or opening of the holding space, or for securing the solid object, individually or in conjunction with one or more of the following components: said components, comprising: a support part connected to the coupling part or extension part, other support parts, a first porous structure, an insertion portion of an intermediate, an interlayer of an intermediate, a substrate, other coupling part or extension parts, additional components of the connected structure; wherein two ends of the said coupling part are respectively connected to two support parts;
Preferably, a coupling part connected to a pair of support parts at sites proximal to the first end of each of the paired support parts; openings are provided between the said pair of support parts at sites proximal to the second end of each of the support parts; a space is formed between said coupling part and the substrate surface exposed by the openings, and becomes at least a part of the holding space.
Preferably, a coupling part connected to a pair of support parts at sites proximal to the first end of each of the paired support parts; openings are provided between the said pair of support parts at sites proximal to the second end of each of the support parts; where extension parts connected to the support parts are provided; a space is formed between said coupling part and the extension parts and becomes at least a part of the holding space.
Preferably, a first coupling part connected to a pair of support parts at sites proximal to the first end of each of the paired support parts; a second coupling part connected to the same pair of support parts at sites proximal to the second end of each of the support parts; a space is formed between said first and second coupling parts and becomes at least a part of the holding space.
Preferably, said space is connected to an opening in a channel or pipeline located on the surface of the substrate; said channel or pipeline is used for placing wires to connect sensors or for delivering drugs.
Preferably, the portion of the said channel on the surface of the substrate not connected with said space is covered by the intermediate body of the interlayer which is connected to the substrate.
Preferably, the drug holding space is provided with a drug output channel or port in the first or second coupling part and a drug input channel or port in the first or second coupling part.
Preferably, the sensor holding space is provided with openings for the sensor tips and/or antenna to pass through the coupling part close to the first ends of the support parts.
Preferably, said coupling part or extension part bodies are secured by the support parts alone, or by the support parts in cooperation with one or more of the following components: the first porous structure, the insertion portion of the intermediate, the interlayer of the intermediate, the substrate, the additional component of the connected structure; the components that cooperate in securing the extension part are located at one end of the extension part or at locations of the extension part other than its ends; the components that cooperate in securing the coupling part are located at locations of the coupling part other than its ends.
Preferably, the two support parts connected to the ends of the said coupling part are located at the same edge interface of the holding space or at different edge interfaces adjacent or opposite to each other.
Preferably, said coupling part or extension part is made together with the support parts or subsequently provided for connection to the support parts.
Preferably, said gap or notch or recess at the support part is provided for connection with the coupling part or extension part.
Preferably, said coupling part or extension part is a formed part or filling surface provided to the support part; said filling surface comprises a filling body which fills up the pores of the struts of the first porous structure at locations adjacent to the support parts and the holding space; said filling body is formed after solidification of a molten substance at a designated site of the connected structure; the filling body substance is a polymeric material or a material identical or similar in nature to the first porous structure or intermediate or substrate.
Preferably, said coupling part or extension part is made of an electrical-conductive material or an electrical-insulating material.
Preferably, said coupling part or extension part is a solid structure or a porous structure having the same or different solid volume fraction as that of the first porous structure.
Preferably, said composite body is provided with anchor points; each anchor point comprises an anchor point body disposed on the second side of the first porous structure proximal to the substrate; said second side of said anchor point body is in contact with and connected to the substrate; a space formed above the first side of the anchor point body is used as a holding space, or for inserting the insertion structure of a solid object to secure the solid object, or as a channel or opening of the holding space, or connected to a channel or opening of the holding space, or connected to an external open space, or connected to a channel or opening provided by one or more of the following components: a first porous structure, a substrate, an additional component of the connected structure.
Preferably, said anchor point further comprises an anchor point periphery, with at least one anchor point periphery provided on the first side of each anchor point body, or, alternatively, with encircled anchor point periphery provided on the first side of the anchor point body; the anchor point periphery is at least partially inserted within the first porous structure, with the first end of the anchor point periphery proximal to the first side of the first porous structure and the second end of the anchor point periphery proximal to the second side of the first porous structure; wherein the anchor point periphery serves as at least a portion of the edge interface; or, the anchor point periphery is provided with a channel or opening for insertion of the insertion structure of the solid object to hold the solid object, or as a channel or opening for holding the space, or is connected to a channel or opening for holding the space, or is connected to an external open space, or is connected to a channel or opening provided by one or more of the following components: the first porous structure, an intermediate, a substrate, an additional component of the connected structure.
Preferably, said space enclosed by the peripheries of the encircled anchor points corresponds to the space on the first side of the anchor point body.
Preferably, said anchor point is connected to at least one other anchor point, by a coupling part; said coupling part comprises a coupling part body, connected to the anchor point body; said coupling part body is located on a second side of the first porous structure proximal to the substrate; said second side of said anchor point body is or is not in contact with the substrate; or, said coupling part comprises said coupling part body, further comprising at least one coupling part sidewall; said coupling part sidewall being at least partially inserted within the first porous structure, the first and second end of the coupling part sidewall being near respectively the first and second side of the first porous structure; said anchor point connected to the coupling part having no anchor point periphery, or said anchor point connected to the coupling part having an anchor point periphery connected to the coupling part sidewall; said coupling part serves as at least part of the edge interface, or, said coupling part is provided with a channel or opening, or for insertion of an insertion structure of the solid object to secure the solid object, or as a channel or opening of the holding space, or is connected to a channel or opening of the holding space, or is connected to an external open space, or is connected to a channel or opening provided by one or more of the following components: a first porous structure, an intermediate, a substrate, an additional component of the connected structure.
Preferably, said anchor point is a solid structure; or, said anchor point is a porous structure with higher solid volume fraction than that of said first porous structure; said coupling part is a solid structure; or, said anchor point is a porous structure with higher solid volume fraction than that of said first porous structure; the solid volume fraction of said coupling part is or is not consistent with that of said anchor point.
Preferably, anchor point body belongs to the interlayer of said intermediate; said anchor point periphery belongs to the support part; said coupling part body belongs to the interlayer of said intermediate and said coupling part sidewall belongs to the support part.
Preferably, there is a pair of contact surfaces between the composite body and the substrate, and they are connected; or, there is a plurality of pairs of contact surfaces between the composite body and the substrate, and at least one pair of contact surfaces are connected to each other; the holding space is provided at locations on the composite body away from the contact surfaces, or the holding space extends to the contact surfaces of the composite body, or the holding space extends through the contact surface of the composite body to the substrate.
Preferably, the contact surface of the substrate comprises a contact area that contacts and connects to one or a plurality of composite bodies, respectively; or that the contact surface of the substrate comprises a plurality of contact areas that contact and connect to the same composite body; or that the contact surface of the substrate comprises a plurality of contact areas, each of which contacts and connects to one or a plurality of corresponding composite bodies, respectively; where there is a plurality of composite bodies, the holding spaces of adjacent composite bodies are independent from or connected to each other.
Preferably, one contact area of said substrate, corresponding to a surface at that substrate in one same direction or in different directions; and a plurality of contact areas of said substrate, corresponding to a surface at that substrate in one same direction or in different directions.
Preferably, at least one pair of contact surfaces between the composite and the substrate form matching position-limiting openings and position-limiting protrusions; the position-limiting openings being formed on one of the paired contact surfaces, and the position-limiting protrusions being formed on the other paired contact surface while insertable into the position-limiting openings; the contact surface having the position-limiting openings and that having the position-limiting protrusions form an interconnected pair of contact surfaces, or a pair of non-connected contact surfaces; wherein the holding space or the channel or opening of the holding space is placed at locations away from the contact surfaces with position-limiting opening and protrusion; or, the holding space or the channel or opening of the holding space is placed on the contact surfaces with position-limiting opening and protrusion at locations avoiding these opening and protrusion; or the holding space or the channel or opening of the holding space is placed at locations of the position-limiting opening and/or position-limiting protrusion or such locations after further modifications, once the composite body has been connected to the substrate, Preferably, at least one pair of contact surfaces of the composite and the substrate form matching surfaces thereby achieving positioning; the pair of contact surfaces are or are not connected to each other; wherein the holding space, or the channel or opening of the holding space, is provided away from or at the positioning contact surfaces.
Preferably, said substrate is provided with a recess, said composite body comprising a part inserted into the recess, between which and the recess of the substrate there are a pair of contact surfaces, where the composite and the substrate are connected; or, between the composite body insertion part and the recess of the substrate, there are multiple pairs of contact surfaces, where the composite and the substrate are connected at least at one pair of the contact surfaces.
Preferably, the part of the composite body at which it is inserted into the recess of the substrate comprises an interlayer portion of the intermediate; said recess of the substrate comprises an opening, a first surface opposite the opening, and a side surface disposed between the opening and the first surface; said interlayer portion of the composite body comprises a second surface in contact with the first surface of the recess, said side surface of the recess being in contact or not in contact with a first porous structure along the corresponding direction of the composite body; or, said interlayer comprises said second surface, and a third surface in contact with the side surfaces of the recess; wherein the second surface and/or the third surface of the interlayer is adjacent to a part of the holding space as at least a portion of the edge interface of the holding space; or, the second surface of the interlayer and/or the third surface adjacent to the holding space is removed such that the holding space extends to the first surface and/or side surfaces of the recess of the substrate; or, the second surface of the interlayer and/or the third surface adjacent to the holding space is used to secure the solid object, either alone or in conjunction with one or more of the following components; or, the second surface of the interlayer and/or the third surface adjacent to the holding space is provided with a channel or opening to be used as the channel or opening of the holding space, or the channel or opening connected to the holding space, or the channel or opening connected to an external open space, or the channel or opening connected to one or more of the following components; said components, comprising: a recess of the substrate, a first porous structure, other parts of the interlayer, other intermediates, additional components of the connected structure.
Preferably, at least one of the sides of said recess of the substrate is beveled, which forms a set angle with the first surface; a third surface in contact with this side is beveled, which forms a set angle with the second surface.
Preferably, said angle is acute.
Preferably, the composite body is connected to the substrate by laser welding or resistance welding; said holding space is formed before, or during, or after connecting the composite body to the substrate.
Preferably, the interlayer is welded to the substrate by laser welding, and after completion of the welding, the space formed in the first porous structure is used as a holding space, or for insertion of the insertion structure of the solid object to hold the solid object, or as a channel or opening of the holding space, or is connected to a channel or opening in the holding space, or is connected to an external open space, or is connected to a channel or opening provided by one or more of the following components: a first porous structure, an intermediate, a substrate, an additional component of the connected structure.
Preferably, said connected structure comprises an intermediate layer of polymeric material; said holding space is provided with or without using a polymeric material layer; The polymeric material layer is formed at chosen locations when a polymeric material is injected into any one of the porous structures of the connected structure, or between any one of the porous structures and the substrate, or between two adjacent porous structures, with the molten polymer material penetrating into the connected part.
Preferably, at least part of the surface of said intermediate layer of polymeric material is used as at least part of the edge interface of the holding space; or, all or part of the holding space is formed within the intermediate layer of polymeric material; or, at least part of the surface of said layer of polymeric material is used alone or in conjunction with one or more of the following components, for securing the solid object; a first porous structure, a substrate, a support part, an interlayer of the intermediate, an additional component of the connected structure.
Preferably, said holding space is provided in a component within the connected structure that does not have a polymeric material interlayer; or, the holding space is provided in an area away from the polymeric material interlayer within a component having a polymeric material interlayer.
Preferably, the intermediate layer of polymeric material is formed within the first porous structure and/or formed within the second porous structure as an interlayer.
Preferably, a polymeric material interlayer is formed between the first porous structure and the substrate; or, a polymeric material interlayer is formed between the second porous structure as the interlayer and the substrate.
Preferably, an intermediate layer of polymeric material is formed between the first side of the first porous structure and a fourth porous structure; the fourth porous structure is arranged separately and forms another composite body with pre-connected or integrally formed fifth porous structure, the fourth and fifth porous structures having different solid volume fraction; the first side of the first porous structure being its side distal from the substrate.
Preferably, a barrier layer is provided within the porous structure where the intermediate layer of polymeric material is located or adjacent thereto, and this barrier is provided for position-limiting the location where the polymeric material is injected and it penetrates; said barrier layer is integrally formed with the porous structure in which it is located or is separately provided to that porous structure.
Preferably, said barrier layer serves as at least part of the edge interface of the holding space, or is used to secure the solid object, either alone or in conjunction with one or more of the following components; a first porous structure, a substrate, a support part, an interlayer of the intermediate, an additional component of the connected structure, a polymeric material layer.
Preferably, said barrier layer is a solid structure or a porous structure, its solid volume fraction being higher than that of the porous structure into which the polymeric material is injected.
Preferably, said polymeric material layer or barrier layer is provided with channels or openings, as channels or openings of holding spaces, or channels or openings connecting to holding spaces, or channels or openings connecting to external open spaces, or channels or openings provided by one or more of the following components; said components, comprising: a first porous structure, a support part, an intermediate interlayer, a substrate, an additional component of the connected structure.
Preferably, said polymeric material layer or barrier layer acts as a closure bodies for the channel or opening.
Another technical solution of the present invention is to provide a prosthetic implant, said prosthetic implant provided with a connected structure of any of the above porous structures and substrates; said prosthetic implant, comprising: a composite, comprising a first porous structure pre-connected or integrally formed with an intermediate; said intermediate having a higher solid volume fraction than the first porous structure; a prosthetic implant body, serving as a substrate; at least part of the surface of said prosthetic implant body provided as a connection region connected to the first porous structure and/or the intermediate of the composite; wherein said connected structure is provided with at least one holding space for placing drugs and/or sensors.
Preferably, said prosthetic implant is an orthopedic prosthetic implant.
Preferably, said prosthetic implant is an joint prosthesis.
Preferably, said composite body is formed as a shell, wrapped around connection regions of said prosthetic body, in contact with and tapered to the connection regions. The surfaces of the body of the prosthetic implant on which the connection regions are located correspond to the same orientation of the body of the prosthetic implant or different orientations.
Preferably, said composite shell is a single unit; or, said composite shell comprises a plurality of shell pieces; wherein the plurality of shell pieces are independent of each other or are connected to each other along at least one adjacent side between the adjacent shell pieces.
Preferably, said prosthetic implant is any of the following: femoral stem, acetabular cup, fusion cage, femoral condyle, tibial tray, spinal prosthetic implant, ankle joint, shoulder joint, elbow joint, finger joint, toe joint, facet joint, mandibular joint, wrist joint, tooth implant.
Preferably, said prosthetic implant is a femoral stem of the hip joint, said stem body of said femoral stem serving as a substrate; at least part of the surface of the proximal end of said stem body being provided with connection regions.
Preferably, said prosthetic implant is an acetabular cup of the hip joint, said cup body serving as a substrate; at least part of the outer surface of the cup body is provided with connection regions.
Preferably, said prosthetic implant is a fusion cage, the fusion cage of said fusion cage serving as a substrate; said connection regions are located at least on the upper and lower surfaces of said fusion cage.
Preferably, said prosthetic implant is a femoral condyle, the body of the femoral condyle serving as a substrate; said femoral condyle body having connection regions on at least a portion of its inner recess surface.
Preferably, said prosthetic implant is a tibial tray, the body of the tibial tray serving as a substrate, said connection regions being located on the inferior surface of the tibial tray.
Preferably, said porous surface structure is further added on its surface with any one or more of the following: an osteoconductive coating, an osteoinductive coating, an antimicrobial coating, a carrier of cells or growth factors.
Preferably, the open space outside the connected structure includes the body structure where the prosthetic implant is implanted.
Preferably, the drug is input to the holding space before, or during, or after implantation of the prosthetic implant.
Preferably, the set substance is input to the holding space before, or during, or after implantation of the prosthetic implant, wherein the set substance reacts with the closure bodies which closes the channel or opening of the holding space, thereby opening up the closure bodies; or, the set substance reacts with a drug in the holding space, causing a change in the form of the drug; or, the set substance reacts with the capsule of the drug, thereby opening up the capsule.
Preferably, said sensor is connected to one end of a wire and the other end of the wire is connected to an interface located on the body surface.
Another technical solution of the present invention is to provide a method of using the connected structure of a porous structure and a substrate, any of the connected structure as mentioned above, comprising: a composite comprising a pre-connected or integrally formed first porous structure with an intermediate, said intermediate having a higher solid volume fraction than that of the first porous structure; a substrate, which is connected to the first porous structure and/or intermediate of the composite; said connected structure provided with at least one holding space for placing drugs; said connected structure provided with sensors for detecting at least one state inside or outside the connected structure, or for detecting a set substance; wherein said set substance is manually input from external sources to the connected structure or is self-generated within the internal environment of the connected structure; the result of the sensor detection being used to determine whether to open the input or output channel or port of the drug holding space.
In the examples of the connected structure of the present invention, a composite body is manufactured by pre-connecting parts or with an integral-forming process (3D printing, etc.), the said composite body comprising a first porous structure and an intermediate (solid body or porous structure with lower porosity) with a higher solid volume fraction; the composite body is effectively bonded to the substrate using a welding method (laser welding or resistance welding); the laser welding beam acts on the intermediate to avoid the original laser energy directly acting on the first porous structure and breaking its struts, making the connection between the composite body and the substrate more reliable; projection resistance welding method uses contact resistance to generate a local heat source to achieve welding, greatly reducing or avoiding the significant decrease in mechanical properties of the substrate caused by hot pressing processes (such as diffusion welding process); the invention can also use the combined projection resistance welding and spot resistance welding to further enhance the welding strength between the intermediate body and the substrate and to reduce the surface damage of the porous surface structure.
The substrate of the connected structure in the examples of the present invention can be manufactured by various processes such as forging, casting or machining or powder metallurgy. Said substrate may be solid object or may be a porous structure with high solid volume fraction (the first porous structure has a lower solid volume fraction than the substrate), while the solid volume fraction of the intermediate may be in between them. The present invention achieve the effective combination of a porous surface and a solid substrate (high solid volume fraction), satisfies the overall requirements of the connected structure and the surface properties at the same time, and avoids the problem of substantial decrease of the mechanical properties of the substrate caused by hot pressing process, etc., so that the strength of the substrate is not substantially affected. The present invention also avoids 3D printing of the entire solid substrate (high solid volume fraction), which simplifies the manufacturing process, thereby reducing manufacturing costs and also saving time.
In the connected structure of the present invention, support parts are provided within the first porous structure for position-limiting the electrodes or indenter to ensure that the surface of the first porous structure is maintained at a predetermined position after the resistance welding process, in order to avoid excessive compression of the first porous structure; when the support parts are used for position-limiting, an insulating material or a conductive material can be used to make the support parts either as solid objects or porous structures with high solid volume fractions; when the support parts use good conductive materials, they can further guide the electrode output current to flow mostly and preferentially through the support parts to the welding interface of the composite body, thereby improving the current conduction efficiency, ensuring the welding strength between the composite body and the substrate, and reducing the damage to the surface of the first porous structure.
The connected structure of the example in the present invention provides an interlayer to the welding interface of the first porous structure, such as an intermediate body and/or raised structures, connecting the porous surface to the substrate through the interlayer; or, raised structures on the substrate can be provided to the welding interface and connects to non-raised parts such as the interlayer body or the first porous structure of the interlayer. The present invention uses the raised structure of the interlayer, or the raised structure of the substrate, to adjust the contact resistance of the welding interface, thereby improving the welding strength.
In the connected structure of the present invention, in order to adjust the contact resistance of the welding interface, change the path of current conduction, or improve the efficiency of current conduction, etc., conductive support parts placed within the first porous structure, the main body of the intermediate, raised structures on the intermediate etc. can be used. 3D printing and other integral-forming processes can be used conveniently, based on optimal designs, to make parts such as the support parts placed within the first porous structure, the main body of the intermediate, raised structures on the intermediate etc. Such technologies simply the manufacturing processes, cut manufacturing costs, and reduce manufacturing time.
The connected structure of the examples in the present invention is provided with a holding space, at least partially through the first porous structure. Preferably, the holding space is formed with various parts connecting the composite body to the substrate, such as the support part, the intermediate body, the raised structure, etc., so as to not only achieve a reliable connection between the composite body and the substrate, but also to make further use of these parts in the formation of the holding space so as, to meet various needs for holding and utilizing the solid objects within the holding space.
The invention utilizes the connected structure of the porous structure and the substrate to form various prosthetic implants, especially various orthopedic prostheses including joint prostheses, such as femoral stem, acetabular cup, etc. It renders the prosthetic implant easy to process and to have high strengths, while optimizing the bone ingrowth properties through the porous surface and minimizing the cross section of the prosthetic implant (such as femoral stem). The connected structure can be equipped with sensors to detect various states around the prosthetic implant and detect infections in a timely manner; it can also be equipped with drugs that can be injected and released as needed to prevent or treat peri-prosthetic infections for a better user experience for the patients.
The present invention provides a connected structure comprising a substrate, an intermediate, and a first porous structure. Said intermediate comprises: an insertion portion and/or an interlayer; at least a portion of the structure of the insertion portion, disposed within the first porous structure; and at least a portion of the structure of the interlayer, disposed between the first porous structure and the substrate.
Taking
In the connected structure of the present invention, at least a portion of the first porous structure 10 and the intermediate are pre-connected to form a composite.
Exemplarily, the composite body is connected to the substrate 30 by a connection between the intermediate and/or the first porous structure 10 and the substrate 30. In some products formed based on the above connected structure, at least a portion of the surface of the composite, such as at least a portion of the surface of the first porous structure 10, may be exposed to become the outer surface of the product (as shown in
wherein the first porous structure 10 is pre-connected to at least a portion of the intermediate to form a composite; or, wherein the first porous structure 10 is a one-step formed structure with at least a portion of the intermediate, such as achieved by a 3D printing additive manufacturing process, or a vapor phase precipitation process, or sintering, etc. Wherein, the timing or manner in which the different portions contained in the intermediate (not limited to the described interlayer and insertion portions), are pre-connected to the first porous structure 10 as a composite, may be the same or different.
In the example where the timing or manner of pre-bonding is different, the interlayer is integrally formed with the first porous structure 10; and the insertion portion is later provided into the first porous structure 10 to connect or contact with the first porous structure 10 and/or the interlayer; thus forming a composite body that is then connected to the substrate 30. For example, the insertion portion is integrally formed with the first porous structure 10, and the interlayer is later fixedly connected to the first porous structure 10 by other means, thereby forming a composite body that is then connected to the substrate 30.
In some examples, after the composite is securely connected to the substrate 30, a portion of the first porous structure 10, and/or a portion of the intermediate can be removed, thereby extending the scenario for subsequent applications.
Preferably, the solid volume fractions of the intermediates are higher than the solid volume fraction of the first porous structure 10. For example, the intermediate may be solid object or may be a porous structure (referred to as the second porous structure 20′, as shown in
For example, the intermediate body 20 shown in
The porous structure, as described above, comprises a multitude of staggered struts, between which a number of multi-directional interconnected, regularly or irregularly shaped pores are formed. When the intermediate body is composed using a second porous structure 20′, said second porous structure 20′ has a higher solid volume fraction than the first porous structure 10, as shown by the thicker and/or less porous struts in the second porous structure 20′.
In different examples, the solid volume fraction of the insertion and the interlayer of the intermediate may be the same or different, however, the solid volume fraction of both parts are higher than the solid volume fraction of the first porous structure 10.
In the preferred example, the first porous structure 10 and the intermediate are both made of metallic materials.
The solid volume fraction of the substrate 30 is higher than the solid volume fraction of the first porous structure 10. Preferably, the substrate 30 is solid object, which facilitates the overall strength of the connected structure. The example substrate 30 is made of a metallic material, formed by various means such as forging, casting, powder metallurgy or metal powder injection molding, and can be subjected to various mechanical processes.
In some examples, a porous structure (referred to as a third porous structure) may be used for the substrate 30, for instance, the substrate 30 being made wholly of a third porous structure, or having certain surfaces pre-made or pre-set with a third porous structure to be in contact with the first porous structure 10 and/or the intermediate. The third porous structure used in each of the above examples for substrate 30 has a higher solid volume fraction than the solid volume fraction of the first porous structure 10, as evidenced by thicker struts and/or lower porosity of the third porous structure. The solid volume fraction of the third porous structure can be the same as or different from the solid volume fraction of the second porous structure 20′ used for the intermediate, preferably the solid volume fraction of the third porous structure being higher.
Exemplarily, both the composite and the substrate 30 are made of conductive materials, and the two are effectively bonded to each other by welding (e.g., laser welding, resistance welding, etc.). Preferably, the substrate 30 and the composite body (e.g., the part of the composite body corresponding to the welding interface) are made of materials with the same or similar melting points. The symbol 40 schematically indicates a welded connection between the two (as in
The application of laser welding in the present invention is to cause a focused laser beam to pass through the first porous structure 10 and weld the interlayer of the intermediate to the substrate 30 at each welding point location, respectively. The application of resistance welding in the present invention is to press two metal workpieces to be welded between two electrodes, form a current circuit between these two electrodes of different polarity so that the current flows through the two workpieces, generating resistance heat in the contact areas and adjacent areas of both surfaces, while leaving said contact areas and adjacent areas in a molten or plastic state, and thus effectively bonding the two workpieces. Wherein, the resistance heat Q is proportional to IR2, R is the contact resistance, I is the current through the workpiece; contact resistance is the resistance generated by the current between two separate workpieces when they are in contact; it can be seen that the greater the current, the greater the value of the resistance heat; the greater the contact resistance, the greater the value of the resistance heat; this allows the contact areas and adjacent areas of the two workpieces to reach a molten or plastic state more quickly and to bond with each other more firmly.
When the present invention uses resistance welding, the electrodes can be rigid, with a fixed form, in any shape, such as plate (flat or curved, etc.), block, column, etc.; for example, the electrodes 401, 402 illustrated in
In this regard, the flexible electrode 401′, as shown in
In some examples, the electrode segment 409 may be inserted into the first porous structure 10 to be in conductive contact with the first porous structure 10 and/or with the intermediate (as in
In addition, between the electrode 401 and the first porous structure 10, a variety of conductive media may be further provided. For example, the conductive medium is in various regular or irregular forms such as powder, foil, filaments, microspheres, particles, etc. (indicated schematically by the symbol 404 of
Compared with the original form in which the electrode 401 is in direct contact with the struts protruding from the surface of the first porous structure 10 (
In some examples, see
Given that the solid volume fraction of the intermediate is higher than that of the first porous structure 10, the electrical conductivity is better, and that the intermediate may not be on the surface of the connected structure, the effect of surface damage on the intermediate due to electrode pressure or resistive heat is relatively small, thus, the above-mentioned conductive medium can be similarly provided between the electrode and the intermediate, or the two can be in direct contact without the conductive medium.
When selecting the material of the conductive medium, it is possible to consider whether the conductive properties are good, such as the use of copper, tin, etc., or to consider the use of materials with the same or similar properties as the first porous structure 10 or intermediate, such as the material used in the connected structure of a prosthetic implant, such as titanium, etc.; or, the similar properties refer to the similar solid volume fraction or conductive properties, etc. Alternatively, the material of the conductive medium can be considered in light of whether it is easy to remove after the current conduction is completed or whether it will affect subsequent use. It is necessary to remove at least a large part of the conductive medium after the completion of welding to leave the pores of the first porous structure 10 open, for example, by emptying the conductive medium out of the pores or by removing the conductive medium with physical or chemical means based on the different states of the conductive medium and the first porous structure 10 (e.g., the melting point of the molten-like substance of the conductive medium can be lower than the melting point of the first porous structure 10); or allowing a small amount of conductive medium to adhere to the first porous structure 10 or intermediate, if doing so does not affect the subsequent use of the connected structure, such as when the conductive medium and the first porous structure 10 or intermediate material is made of the same or similar materials, and it is not prone to peel off in subsequent use.
With resistance welding, two composite bodies can be welded onto two opposite sides of the substrate 30 simultaneously or successively (as in
If two composites are connected successively, when the first composite is connected on the first side of the substrate 30, a current circuit is formed between the electrodes of the two polarities, into which the first composite is connected to the substrate 30 (the welded interface between the two is in close contact), one polar electrode may be in conductive contact with the first composite using one or more of the above, and the other polar electrode may similarly be in one or more of the above conductive contact with the substrate 30. Then, when the second composite is connected to the second side of the substrate 30, a current circuit is formed between the two polar electrodes, into which the substrate 30, the second composite, which has been connected to the first composite, is connected (the second side of the substrate 30 is in close contact with the weld interface of the second composite). The electrodes of each polarity may be in conductive contact with the corresponding side of the composite using one or more of the above; alternatively, one polarity may be in conductive contact with the second composite using one or more of the above, and the other polarity may be similarly in conductive contact with the substrate 30 using one or more of the above (across the first side of the composite).
The said connected structure of the present invention is provided with one or more holding spaces in which to place the contained substance as desired. In different examples, the first porous structure 10, the intermediate, and the substrate 30, may be provided with holding spaces individually; or, the first porous structure 10 and the intermediate and/or the substrate 30, or the intermediate and the substrate 30, may be provided with holding spaces cooperatively.
The present invention does not make specific limitations on the contained substances and can be decided according to the actual application. The shape size quantity, etc. of the holding space is not limited and is generally decided based on the actual use of the contained substance, the composite body, the substrate 30, the connected structure or its holding space and the contained substance, etc., such as considering the shape, type, size, etc. of the contained substance, considering the structure, connection part, overall strength, etc. of the composite body and/or the substrate 30, but not limited to these factors. The holding space may be formed before, during, or after the connection of the composite body to the substrate 30. The contained substance may be solid object, liquid, or gaseous. The contained substance may be in a more discrete state resembling a particle, powder; or it may be a solid object with a more stable form and structure (the volume of the solid object may be less than, equal to, or greater than the volume of the holding space; or, the solid object may be less than, equal to, or greater than the edge interface to which the holding space is fixed in a certain direction). As shown in
The holding space may be relatively closed (e.g., holding spaces 502, 503 of
And depending on differences in the structure of the holding space itself, its location, the state and usage of the contained substances, etc., the said holding space, or its channel/opening, may connect to the first porous structure 10, intermediate, substrate 30, etc., or to the external open space through these components, without any specific limitation in this regard herein. For example, the opening 77′ of the holding space 508 shown in
The parts used to close the channels or openings are referred to as closure bodies (e.g., closure bodies 93, 94 of
There may be no first porous structure 10, or intermediate, or substrate 30 in the holding space, or, in some examples, a portion of the first porous structure 10 or intermediate or substrate 30 may be allowed to remain in the holding space if it does not interfere with the placement or use of the contained substances (e.g., a portion of the first porous structure 10 is left in the holding space 508 of
In some examples, certain portions of the first porous structure 10 or intermediate or substrate 30 may also serve as the edge interface of the holding space in a certain direction (e.g.,
Alternatively, in some examples, the edge interfaces of the holding space along all or some directions are component structures additionally provided either before the composite is connected to the substrate 30, such as by pre-connection or one-step forming, with the first porous structure 10 or intermediate or substrate 30; or during or after the connection of the composite to the substrate 30.
A plurality of Embodiments of the present invention are described hereinafter in connection with the attached drawings. The orientation described below (e.g., up, down, left, right, etc.) is illustrated corresponding to the orientation of each component in the attached drawings and is not intended as a limitation on the orientation of the connected structure when it is actually used.
In this Embodiment, the first porous structure 10 is used to design the holding space and place the contained substance.
In conjunction with
One or more directions around the periphery of the holding space is adjacent to the first porous structure 10 or other components of the connected structure, or connected to the external open space. The holding space may contain a portion of the first porous structure 10 and may just contain spaces without containing first porous structure 10.
The holding space may be formed during the process of manufacturing the first porous structure 10, such as one-step forming processes, in which the first porous structure 10 is pre-formed; or, the holding space may be formed at a later stage by removing a portion of the already manufactured first porous structure 10, such as by various machining means such as cutting, gouging, and the like. Alternatively, for example, the first porous structure 10 is not pre-formed into the holding space, but is compressed to a certain extent by an external force at the area where the contained substances will be placed, so that a recess is formed wherein to function as the holding space.
Exemplarily, the holding spaces 501, 502, 503, 505 shown in
Exemplarily, the holding space 506 shown in
Alternatively, one of the larger pores within the first porous structure 10 is used directly as a holding space (see holding space 507 of
The first porous structure 10 around the holding space may apply loads on or be connected to the contained substance. Loading on the contained substance means bearing the contained substance from at least one direction, for example, for example carrying the bottom of the contained substance from below, but not limited thereto.
Connection to the contained substance, depending on the form of the contained substance, may refer to connection to the contained substance itself or to the external capsule of the contained substance (e.g., container, shell, etc.); said connection, for example, is adhesive bonding, welding, use of matching connectors, position-limiting structures, etc., without limitation. The following involves other parts of the structure (intermediates, substrate 30, etc.) to the contained substance and its loading or connecting to the contained substance have similar meanings, and we will not repeat herein.
Some of the contained substances are relatively stable entities 61 in structure, form, etc., when placed and/or used, and can be tightly fitted with the first porous structure 10 on its periphery (at least one direction on both sides) so that the whole substance is set in the resulting holding space. In this example, the width of the contained substance is equal to or slightly larger than the gap between the left and right sides of the first porous structure 10 and the contained substance is fixed in close contact with at least the left and right sides the first porous structure 10 after insertion. If the outer capsule of the contained substance is a stable solid object as described above, it can be tightly fitted to the first porous structure 10 around it in a similar manner.
The holding space at the first porous structure 10 can be provided with channels or openings along some directions (e.g., top or side) that lead to external open spaces (e.g., the holding spaces 501, 504, 505 of
The top surface of the intermediate body 20 shown in
Exemplarily, the location of the first porous structure 10 adjacent to the holding space may form a position-limiting protrusion extending into the holding space in contact with the surface of the solid contained substances (or its enclosure bodies bodies) for position-limiting; the position-limiting protrusion may be arranged in one, two or more directions towards the solid object respectively. Alternatively, a number of position-limiting protrusions adjacent to one of the directions of the holding space may be simultaneously located on the same side of the solid object to restrict it; the position-limiting protrusions may be the ends of some struts of the first porous structure 10 itself located at the edge interface of the holding space, or they may be separately formed components (e.g., bumps, pins, etc., with the same or different solid volume fraction as the first porous structure 10). Alternatively, the corresponding position on the surface of the holding space (or its enclosure bodies) is further formed with a position-limiting recess matching the position-limiting protrusion, said position-limiting protrusion being able to be set in the position-limiting recess accordingly. Another example is the formation of outwardly facing position-limiting protrusions on the surface of the contained substances (or its enclosure bodies), capable of being set in the pores of the first porous structure 10 and imposing position-limiting on the contained substances; the pores corresponding to the position-limiting protrusions may be kept in the same form as when the first porous structure 10 was made, or may be made to better match the shape and size of the position-limiting protrusions by later processing.
As shown in
As shown in
If the holding space itself has a stable solid object edge interface, the first porous structure 10 or other component nearby, etc., can secure the solid object edge interface of the holding space (not limited to carrying, connecting, fastening, or position-limiting) in a similar manner to the fixation of solid contained substance; and the solid object edge interface of the holding space can also be secured to the contained substance of the internally placed solid object or its capsule in a similar manner. The solid object edge interface of the holding space can also be secured to the solid contained substance or its enclosure bodies by similar means.
In some examples, the first porous structure 10 itself has pores that can serve as channels or openings of the holding space; alternatively, additional more regularly shaped channels or openings can be opened at the first porous structure 10.
Depending on the actual application, the various channels or openings in the holding space, as described above, may remain open or may be closed by enclosure bodies (on a short-term or long-term basis); for example, certain channels or openings are closed after placement of the contained substance into the holding space; or, certain channels or openings are pre-closed (and can be opened for subsequent use).
The solid volume fraction of the enclosure bodies are designed according to the needs of the practical application. The closure bodies may be solid object; or, the closure bodies may be a porous structure (the solid volume fraction may be the same or different from the solid volume fraction of the first porous structure 10). The material of some of the enclosure bodies or their solid volume fraction may be designed to allow for the channel of contained substance material through the enclosure bodies (e.g., to enter and exit the holding space).
The example closure bodies may be integrally formed with the first porous structure 10. It may also be provided later, for example, after the first porous structure 10 is formed into a composite with the intermediate, or after the composite is connected to the substrate 30, or after placement of the contained substance; for example, by injecting some molten substance (which may be injected with a polymeric material, or with a material identical or similar in nature to, but not limited to, the first porous structure 10 or the intermediate or the substrate 30), which solidifies to form the closure bodies, or, alternatively, the formed part is directly inserted or covered in a location adjacent to the first porous structure 10 within the holding space (if necessary, the inserted or covered part can be further connected to the adjacent first porous structure 10 or intermediate or substrate 30, or a plurality of the inserted or covered parts can be connected to each other). Exemplarily, the portion of the first porous structure 10 that was removed when the channel or opening was opened may also be placed back into the channel or opening as a closure bodies.
Given that the first porous structure 10 itself has numerous pores, it is also possible to use other parts of the connected structure (intermediate, substrate 30, etc.) or, alternatively, a separately provided component structure to close the edge interfaces, channels or openings of the holding space for the holding space formed therein.
In some examples, a number of formed parts and/or filling surfaces (of any shape and size as desired) are further provided at the first porous structure 10 adjacent to the holding space. In this case, the formed parts are externally made and placed to the corresponding locations within the connected structure. For example, suppose the edge interfaces of the holding spaces 514, 515, 516 shown in
By placing filler bodies, some neighboring struts of the first porous structure 10 are coupled to form a filler surface (combination of filler and struts). The left one of
Said forming component and/or filling surface may be used as a closure bodies, to close the channel or opening of the holding space. They may also be used to construct a part of the edge interface of the holding space: for example, to achieve boundary delimitation; or, to secure the contained substance (such as supporting, connecting, tight fitting or position-limiting, etc.) alone or in conjunction with other edge interfaces, or other components of the connected structure, without being limited to these specific cases. Said forming components or filling body of the filler surface may be formed as closure bodies, without being limited to such.
For example, a forming part or a filling surface may independently cover all or parts of the area corresponding to one side of the edge interface. Alternatively, a plurality of formed parts cooperating with each other cover all or part of the area corresponding to one side of the edge interface (the plurality of formed parts covering part of the area may be spaced out or close to each other without spacing).
Alternatively, all or part of the area corresponding to the edge interface on one side is formed with a filling surface. For example, the forming part and the filling surface can be provided simultaneously, for example, cooperatively on the same side of the edge interface, or on edge interfaces of different directions.
If one or some directions of the formed part or filling surface, or its edge interface do not need to be completely closed, the channel or opening of the holding space can be allowed to be placed at the formed part or filling surface or at other locations of their edge interfaces; or, distributed between the forming parts (or filling surfaces) near the edge interface region; or, some of the pores of the first porous structure 10 are open at the filler surface (or in an uncovered area of the edge interface); or, materials of certain compositions (or solid volume fraction) through which the contained substances can pass may form said formed parts or filling surfaces.
The specifications of the holding space or contained substance in this Embodiment that are associated with the first porous structure 10 can all be applied in other Embodiments.
In this Embodiment, the holding space is designed and the contained substance is placed based on the cooperation of the first porous structure 10 with the interlayer of the intermediate, as shown in
Preferably, the connection between the interlayer of the intermediate and the substrate 30 is achieved with laser welding or resistance welding.
In some examples, the beam of laser welding or the electrode of resistance welding can directly contact the exposed surface of the interlayer of the intermediate itself from some directions; in some examples, the beam of laser welding or the electrode of resistance welding can pass through the first porous structure 10 itself or the gaps opened therein to reach the location of the interlayer and make direct contact with the interlayer (e.g., the beam of laser welding in
As shown in
As shown in
The intermediate body 20 and the first porous structure 10 shown in
The intermediate body 20 and the raised structure 21 can be provided separately or simultaneously. When the intermediate body 20 or the raised structure 21 is provided separately (
Without limiting the number, shape, or texture pattern formed on the surface of the first porous structure 10 or the intermediate body 20 by distributing a number of raised structures 21, etc., the present invention,
In the direction shown in
As shown in
When the holding space is provided by the first porous structure 10 in cooperation with the interlayer of the intermediate, at least a part of the holding space is formed within the first porous structure 10. Said holding space may extend to the interlayer of the intermediate in some directions: the positions on the interlayer corresponding to these extension part directions may not be formed with openings, so that the interlayer becomes the edge interface of the holding space in these directions (e.g., the intermediate body 20 of
Similarly, in the example where the holding space extends into the substrate 30, openings may or may not be formed in the substrate 30 at locations corresponding to these directions of extension part, allowing the substrate 30 to be the edge interface of the holding space in these directions, or allowing the holding space to extend into or even through the substrate 30 by means of a recessed or through structure formed in the substrate 30 at corresponding locations. this increases the volume of the contained substance The volume of the holding space can be increased; when necessary, the contained substance can also be fixed through the interlayer or the substrate 30.
The intermediate body 20 of the intermediate can serve as the edge interface of the holding space near the side of the substrate 30 (e.g.,
Exemplarily, for the intermediate body 20 that is within the holding space, a recessed structure that can be extended for the holding space can be formed by reducing the thickness of the upper surface of this part of the intermediate body 20.
The intermediate body 20, which is in the range of the holding space, may be closed, or may be provided with a channel or opening. The space between adjacent raised structures 21 within the holding space can be a channel or opening that connects the holding space to the outside. Referring to the Embodiments documented above, said channels or openings may be open or closed (for a short or long period of time) by means of closure bodies. In addition to the closure bodies described in other Embodiments, the portion cut off at the intermediate body 20 to open the channel or opening can be used as an enclosing body to enforce closure bodies after placement of the contained substances.
Exemplarily, the intermediate body 20 may further form a position-limiting protrusion extending into the holding space to position-limiting it in contact with the surface of the contained substances (or its closure bodies); the surface of the contained substances (or its closure bodies) may further form a position-limiting recess to correspond to said position-limiting protrusion; or, the surface of the contained substances (or its closure bodies) may form a position-limiting protrusion extending outward into the holding space and the intermediate body 20 forms a corresponding recess. The position-limiting protrusions or position-limiting recess of the intermediate body 20 may be provided alone or in conjunction with the position-limiting protrusions or position-limiting recess of the first porous structure 10 to restrict the surfaces of the contained substances (or their covering bodies) in different directions, respectively.
When the interlayer alone contains the raised structures 21 (corresponding to the example without intermediate body 20), the spacing distance between adjacent raised bumps of raised structures 21 is reasonably set: in some examples, the contained substances (or their capsules) are partially set in the spaces between adjacent raised bumps of the raised structure 21 and can be cooperatively secured by the surrounding first porous structure 10, the substrate 30 between raised bumps of the raised structures 21, and other components (as in
Considering that raised structures 21 is provided to reduce contact resistance and may itself be small in size, it is possible not to provide position-limiting protrusions or recess on raised structures 21. In some examples, it is allowed to set the position-limiting protrusions or recess on the surface (such as the top or side) of the raised structure 21, or on other parts arranged in extension part on the basis of said surface.
Some examples have certain edge interfaces of the holding space in the form of formed parts (see Example 1). For ease of description, a wall plate is used here as an example. Said wall plates may be supported by or connected to the interlayer of the intermediate; for example, longitudinally arranged wall plates that may be erected on the top surface of the intermediate body 20; or, for example, transversely arranged wall plates that may be stacked on the top surface of the intermediate body 20 (in contact with or connected to each other). For example, the longitudinally or transversely arranged wall plates may be supported or connected by the upper surface of the raised structure 21 (e.g., wall panel 519 on the right side of
In this Embodiment, for example, the specific features related to the intermediate body 20 or the raised structure 21 of the interlayer, and the holding space or the contained substance can a1 be applied in other Embodiments.
As shown in
When joining two components (e.g., between substrate 30 and a porous structure, or between adjacent porous structures) by injecting a polymer material, for example, a high-temperature molten polymer material that penetrates simultaneously into the surfaces of the two components to be connected (the surfaces of the two components to be connected touch each other or are separated by a short distance); or by placing the polymer material into and between the surfaces of the two components to be connected, the two parts and the polymer material are heated up as a whole to melt the polymer material, so that it penetrates simultaneously into the two surfaces to be connected.
Exemplarily, as shown in
In the example where a second porous structure 20′ is used for the interlayer itself pre-connected with the first porous structure 10, as shown in
The substrate 30 which is connected to the first porous structure 10 or the second porous structure 20′ through a polymeric material may be a solid object. Preferably, the surface of the substrate 30 is rough or formed with pores. Alternatively, the substrate 30 connected to the first porous structure 10 or the second porous structure 20′ by means of a polymeric material is overall a third porous structure (higher solid volume fraction than the first porous structure 10), or at least the surface of the substrate 30 being a third porous structure. In several of the above examples, at least part of the surface of the first porous structure 10 (e.g., the top surface) is exposed to external open space.
In some examples, it is assumed that the first porous structure 10 is already connected to the substrate 30, or that the composite comprising the first porous structure 10 and the intermediate is already connected to the substrate 30 (as shown in
This fourth porous structure 10′ is provided independently, or, alternatively, is pre-connected with the fifth porous structure 10″ to form another composite (similar to the way how to form a composite with the first porous structure 10 pre-connected with the second porous structure 20′), and at least part of the surface of said fourth porous structure 10′ (e.g. on the side not connected to the first porous structure 10, in this case the top surface) is exposed to external open space. The solid volume fractions of said fourth porous structure 10′ and fifth porous structure 10″ are different, and the respective solid volume fractions of the fourth porous structure 10′, and fifth porous structure 10″ can be same as or different from that of any of the first porous structure 10, the second porous structure 20′, and the third porous structure.
Various examples of this Embodiment are formed by injecting polymeric materials for connection of the corresponding components while forming porous structures exposed to external open space on at least one side of the substrate 30. In the case of an orthopedic prosthetic implant with a connected structure, the solid volume fraction of the exposed porous structure (such as the first porous structure 10 of
In these examples of this Embodiment, the thickness of the substrate 30 can be appropriately reduced by the polymer material incorporated, which can ensure the basic strength of the whole connected structure and also improve the stress shielding phenomenon. The stress shielding phenomenon means that when two materials with different elastic moduli are loaded together, the one with the larger elastic modulus will bear more stress; the elastic modulus of the substrate 30 is much larger than that of the bone, so the bone bears less stress, which can lead to postoperative osteolysis in severe cases. Since the present invention incorporates polymer material with elastic modulus less than that of substrate 30, the stress shielding phenomenon will be improved accordingly.
As shown in
The injected polymer material and the regions of the two parts connected by the polymer material are called the polymer material intermediate layer 400. The connected structure of this Embodiment contains at least one polymer material intermediate layer 400.
The location of the holding space may avoid the polymeric material intermediate layer 400 and be set at other porous structures that are not connected to the polymeric material intermediate layer 400, or at a location of the same porous structure that is not in contact with the polymeric material intermediate layer 400. Alternatively, it is provided at the intermediate or substrate 30 that is not in contact with the polymeric material intermediate layer 400.
For example, the holding space 413 of
In some examples, the polymeric material layer or barrier layer 401 thereof is used to provide the holding space and secure the contained substance. For example, a portion of the holding space is located within the polymeric material layer, and the holding space may extend to a component to which the polymeric material is connected (e.g., porous structure, substrate 30, etc.), or to other components of the connected structure through a notch in the connected component, or further connected to the external space; or, the holding space may be located entirely within the polymeric material layer without extension part.
For example, the holding space 411 of
The contained substances may be in direct contact with the polymer material or barrier layer 401 if it does not interfere with the placement and/or use of the contained substances. The layer of polymer material, or barrier layer 401 thereof, may be used to form an edge interface on one side of the holding space. When using barrier plate 401, the holding space may be formed on the side of barrier plate 401 in close proximity to the polymeric material or on the other side away from the polymeric material. The barrier layer 401 can be used alone or in conjunction with other component structures to secure (load, connect, tight fit, position-limit, etc.) the contained substance or its capsule. The polymeric material layer, if suitably formed, can also be used alone or in conjunction with other component structures to provide similar fixation of the contained substances or its enclosure bodies (the polymeric material can at least carry the contained substances).
Examples of using the polymeric material intermediate layer 400 as a certain edge interface can be seen in the following figures:
Examples of a barrier layer 401 as an edge interface on one side can be seen in the holding space 417 of
The parts of the intermediate layer 400 or barrier layer 401 of polymeric material, corresponding to the holding space, may be closed, or may be provided with a channel or opening for the overlying holding space. Examples are seen in
Another example is a certain form of polymeric material or barrier layer 401 that can allow a contained substance to pass from that polymeric material or barrier layer 401. Alternatively, it is possible to make a formed part or filler somewhere, or to make a closure bodies somewhere, using the injection of the polymer material, or the formation of the barrier layer 401.
The polymer material injection, the polymer material intermediate layer 400 and the barrier layer 401, and the characteristics of the holding space or the contained substances in relation thereto etc, as in this Embodiment, can be applied to other Embodiments.
As seen in
The preferred support part is inserted substantially from the side of the first porous structure 10 away from the substrate 30, to a direction towards the side close to the substrate 30. The angle of insertion can vary. In the illustrated direction, for example, it can be inserted vertically or with some inclination. When there are multiple support parts, their respective insertion angles can be the same or different, depending on the actual application.
The support part may secure (e.g., carry, connect, tightly fit, or position-limit, etc.) to the contained substance, either alone, or in conjunction with other support parts, or in conjunction with other component structures, without limitation. The capsule of the contained substance, or the edge interface of the solid object of the holding space, etc., may be similarly secured, without being described in detail.
For example, a support part may be coupled to a contained substance; at least one side surface of the contained substance may be coupled to one or more support parts.
The support parts may carry the contained substance; a contained substance may be carried by one or more support parts. The plurality of support parts may carry or connect the contained substances from the same direction, or may carry, connect, tightly fit, or position-limit the contained substances from different directions. The support parts may also be provided through the load. The surface of the contained substances not carried or connected by the support parts may be suspended or may be secured by other components such as the first porous structure 10 or the intermediate interlayer or substrate 30.
In
In some examples, where the support part itself is sufficiently large compared to the contained substances to be placed, or where the support part is hollow, one or more holding spaces may be formed directly inside the support part (e.g., holding spaces are placed inside support part 810 of
For example, the support part 813 of
The holding space, gap or opening, etc., constructed based on the support part may be pre-designed and formed while the support part is made, or may be formed by subsequent processing (formed prior to placement of the contained substances, and not restricted to after the support part is made, or after the first porous structure 10 forms a composite with the intermediate, or after the composite is connected to the substrate 30).
Depending on the way of securing the contained substance, the support part can be an edge interface in one or more directions of the holding space. One or more corresponding support parts may be located on one side of the edge interface (other edge sides with or without support parts). The spacing between adjacent support parts may be open, and is connected to the neighboring first porous structure 10. or external open space; or, adjacent support parts are close to each other without spacing; or, the spacing between adjacent support parts is closed (e.g., by forming wall plates, filler surfaces, polymeric material layers, barrier plates, etc. as described in other Embodiments to implement closure, and not limited thereto). Alternatively, when the support parts are sufficiently large, one or more directional surfaces of one support part (which may be outer surfaces or inner surfaces formed by openings etc.) are used as edge interfaces in one or more directions of the holding space (e.g., the surface on one side of the support part 820 of
The channel or opening of the holding space can be located at the edge interface close to the support part (e.g., avoiding the support part itself), or in the space between adjacent support parts, or a channel or opening can be formed directly by running through a portion of the support part (running through transverse, longitudinal, or other directions in isolation or in combination). Said channels or openings may be left open after placement of the contained substance, or closed by closure bodies (temporarily or permanently).
For example, the support part 810 of
The support part may have direct contact or connection with the first porous structure 10 around its insertion site; or, there is no such contact or connection, but the support part is inserted at a gap formed within the first porous structure 10; which may be pre-designed and formed with the first porous structure 10 or by later processing (the timing of the later processing is not limited to after the formation of the first porous structure 10, or after the formation of the composite of the first porous structure 10 with the intermediate, or after the composite is connected to the substrate 30). As in
The structure, number, shape, size and location of the support part are not restricted and can be determined according to actual applications. For example, the support part can be plate, strip, block, column, peg, etc., and others not limited to the above; its transverse (or longitudinal) cross-section, can be of a certain geometric shape, or irregular shaped; its cross-section shape and size at each height can be the same or different; its side surface can be flat, curved, arbitrary curved, or a combination of a variety of shapes. A support part can be a single piece, or can be a plurality of parts assembled.
Assuming that the support of each of the other examples is circular in cross-section, while
The material of the support part is not limited if it is mainly for the purpose of holding the object, etc. The support part itself may be integrally formed with the first porous structure 10, etc., or may be provided separately at a later stage (or before placing the contained substance). In some examples, the support part is made of a molten substance that solidifies after injection to the first porous structure 10.
Alternatively, in some preferred examples, the composite is connected to the substrate 30 by resistance welding, wherein the support part may function as an insertion portion of an intermediate, placed into the first porous structure 10 prior to welding, to function as an electrode position-limit and/or to enhance current conduction.
A support column is used as an example structure of a support part. The features described in each example of the support column can be applied to other support parts, and vice versa. The cross-sectional shape of the support column is not limited (it can be geometric, circular or some kind of polygon, or irregularly shaped), and a cylinder is used as an example in each figure, and the directions depicted are the directions shown in the figures.
In the example of resistance welding, the support part can be used to position-limit the electrode. Since the electrode of resistance welding needs to be pressed against the workpiece to be welded while providing current, it is prone to cause damage to the surface of the workpiece due to the resistance heat generated or the pressure applied.
Considering that, in the connected structure, the first porous structure 10 itself has numerous pores and usually at least part of the surface of the first porous structure 10 is exposed and more susceptible to damage from resistive heat or pressure; for example, the pores in the compressed part of the first porous structure 10 may become smaller, the struts may break or shift, affecting the porous form of its surface as originally designed, and indentation marks may also be formed; if the resistive heat is too high, it may also leave burning marks on the surface of the first porous structure 10.
Thus, the examples below are illustrated mainly in terms of a support part to position-limit the electrode (first polar electrode 401) close to the side of the first porous structure 10. The second polar electrode 402, for example, is in contact with the bottom surface of the substrate 30, or with another composite connected to the bottom side of the substrate 30; and the substrate 30 or intermediate has a higher solid volume fraction, etc., than the first porous structure 10, and may not have a surface that would be exposed to the exterior; thus, a support part may be provided to position-limit the second polar electrode 402 in a similar manner, or may not position-limit the second polar electrodes 402.
In the first example, as shown in
In the second example, as shown in
In the third example, as shown in
In the first and second examples mentioned above, since the electrode 401 (or the electrode segment 405) is still in conductive contact with the first porous structure 10, the support part 81 or 82 can be made of either insulating or conductive material; in the third example mentioned above, the electrode 401 (or the electrode segment 405) is not in conductive contact with the first porous structure 10, the support 83 needs to be made of conductive material so that the current applied through the electrode 401 (or the electrode segment 405) can be conducted through the support 83. The support part 81 or 82 made of insulating material is utilized by the present invention for its function of position-limiting the position. The support parts 81, 82, 83 made of conductive material, on the other hand, can further enhance current conduction.
Preferably, the solid volume fraction of the support part is higher than the solid volume fraction of the first porous structure 10, and if the support part is solid object, or a porous structure with higher solid volume fraction, the structural strength is enhanced to effectively resist the force when the electrode is pressed. On the other hand, when such a support is a good conductor, the support itself has less resistance and better electrical conductivity than the first porous structure 10 with pores in its vicinity (with air and other bad conductors inside the pores), and the current is preferentially conducted through the support to the interface between the composite and the substrate 30; according to the previous section, the resistance heat Q is proportional to IR2, and if the other structures remain unchanged, the use of the support part of the good conductor increases the current I in the circuit by reducing the resistance in the current conduction path, which in turn increases the value of the resistive heat and improves the efficiency and strength of the welding bond.
In considering the position-limiting function, it is necessary to design the top height of the support part (see the first example to the third example), but the other parts can be set arbitrarily as needed. And even when the entire support part of the good conductor is buried in the first porous structure 10 and there is still a first porous structure 10 above and below the support part (such as the support part 801 shown in
Alternatively, the bottom of the support part of the good conductor, which may extend downward to the bottom of the first porous structure 10, contacts the interlayer or substrate 30, conducting the current more quickly near the interface where the composite is connected to the substrate 30. For example, the support part 811 of
The support part may be inserted in a gap in the first porous structure 10 without contacting the surrounding first porous structure 10 to avoid damage to the surrounding first porous structure 10 by conducting resistive heat to the surface of the surrounding first porous structure 10 (as shown in
And according to the above equation, if it is possible to increase the contact resistance R at the same time as the current I increases, it is possible to make the resistance heat even greater. The contact resistance R is more related to the contact interface state of the workpiece to be welded (composite, substrate 30). For this reason, in addition to providing the support part of the good conductor separately, it is possible in some examples to provide the support part together with the interlayer of the intermediate, for example, during resistance welding, the intermediate contains both the support part and the intermediate body 20, both the support part and the raised structure 21, both the support part, the intermediate body 20 and the raised structure 21, etc.
The support part and the intermediate body 20 may or may not be in contact with each other (the intermediate body 20 is provided with raised structures 21 below or without raised structures 21); the number of the support part and raised structures 21 may be the same or different, and the arrangement of the two may correspond to each other or be staggered (raised structures 21 may be located below the intermediate body 20 or directly below the first porous structure 10), and the support part may or may not be in direct contact with the raised structure 21. Preferably, it is made that the support part is in direct conductive contact with the intermediate part, and/or that the electrodes are in direct conductive contact with the support part, avoiding losses from current conduction through the first porous structure 10. Of course, it is allowed that in some examples the current applied by the electrode is first conducted to the support part through some parts of the first porous structure 10, or that the current obtained by the support part is conducted to the intermediate or the substrate 30 through some parts of the first porous structure 10.
For example,
For example, the interlayers of
In one example, as shown in
A variation of the above example is to make the first polar electrode directly contact at least one of the support part 80, the intermediate body 20, and raised structures 21 located at the edge from the side, and conduct current to the intermediate at other locations via the conductive parts of the edge, and thus weld the composite body to the substrate 30; the side of the first porous structure 10 of this variation example may not be exposed, and the support part 80, the at least one of the intermediate body 20, and the raised structure 21 has an exposed surface located directly at the edge of the composite body to make conductive contact with the first polar electrode; alternatively, the first polar electrode may be inserted inside the first porous structure 10 in the edge region to make conductive contact with at least one of the support part 80, the intermediate body 20, and the raised structure 21 located in the edge region. For example, the first polar electrode 407 of
Based on the above example and this variation, it can be understood that the side electrode can also be applied to the case where there is no support part or the support part is not conductive, as long as there are other intermediates (such as the interlayer) can be directly contacted with the side electrode, or the side electrode can be conducted to other intermediates (such as the interlayer) via the first porous structure 10 in the edge area, the path of current flow can be somewhat shortened and the welding efficiency can be improved.
Another variant, as shown in
The support part itself may be integrally formed or pre-connected to the first porous structure 10 and/or the interlayer, etc., or may be provided later (at any point before welding); and in addition to securing the contained substance (or its capsule or holding space) in the state at which it is made or when it is welded, in some examples the support part may be machined after welding. For example, if the surface to be fixed is flat, a part of the side of the cylindrical support part can be cut off to form a flat surface to increase the surface to be fixed to the holding space; if the surface to be fixed of the holding space is of other shapes, a matching surface shape can be machined on the support part. For example, after the resistance welding, an opening is made at a part of the support part to secure the contained substance or install a part securing the contained substance. If an opening is formed before resistance welding, the gap in the opening may affect the conductive effect of the support part itself Another example is that after resistance welding, the support part may be opened, sectioned, or completely removed (e.g.,
In this Embodiment, the relevant characteristics of the support part, the holding space and the contained substance can be applied to other Embodiments.
In this Embodiment, some examples of variations concerning the support part, the first porous structure 10, the electrode, etc. are provided, whereby the holding space is designed and the contained substance is placed. The support column is still used as an example in the figures.
In the third example of Embodiment IV, the top surface of the support part is higher than the top surface of the first porous structure 10 (e.g., support part 83 of
Alternatively, one or more of the support parts above the top surface of the first porous structure 10 can be retained after the resistance welding is completed (the higher portions of the other support parts can be removed), and a corresponding hoop structure (e.g., a ring structure formed by adapting the cross section of the support part) can be formed over the contained substance (or capsule, solid object edge of the holding space) so that the hoop structure is over the corresponding support part; the top surface of the support part may be higher, equal to or lower than the top surface of the hoop structure. In this example, the contained substance is located on the top surface of the first porous structure 10 (next to the support part) and further carried or connected by the top surface of the first porous structure 10 (the top surface may remain flush or form a downward recess to hold the contained substances), or, alternatively, the contained substance, etc. may be suspended without contact with the top surface of the first porous structure 10. As shown in
Referring to the above, based on the first or second example of Embodiment IV, the first porous structure 10 around the top of one or more of the support parts is removed so that the top of the support parts is exposed, and the hoop structure is provided (contained substance, capsule, solid edge interface of the holding space, etc.) on the top of the support parts to secure the contained substance etc.
For example, if the top of the support part 805 of
Similarly, when the holding space matches parts of the support part at certain heights (eg the bottom or middle part), the hoop structure designed for securing the contained substance (or its capsule, or solid edge interface of the holding space, etc.) can be secured at corresponding locations on the support part (with the nearby portion of the first porous structure removed and a channel or opening provided thereto). If the hoop structure can be conveniently slid and snapped onto the support part from its top or bottom end, the hoop structure can be provided as a closed-hoop structure (
In some examples, after completing welding, one or some of the support parts are completely or partially removed, leaving a corresponding gap in the first porous structure 10, and a matching insertion structure (e.g., column, peg, block, plate, etc. and others not confined by the above) is formed near the contained substance (or its capsule, or solid edge interface of the holding space, etc.), and the insertion structure can be inserted in the gap left by the removal of the support parts. The first porous structure 10 on the side of the gap is used to position-limit the insertion structure and prevent it from sliding laterally. If the insertion structure fits tightly into the said gap, the contained substance etc. is thereby secured; if they do not fit tightly, they function mainly for position-limit and need to work in conjunction with other parts of the connected structure for securing the contained substance. For example, the contained substances may be located on the top surface of the first porous structure 10 (at the part next to the gap), may be further carried or connected by the top surface of the first porous structure 10 (the top surface may remain flush or form a downward recess to hold the contained substances), or may be suspended without contacting with the top surface of the first porous structure 10.
For example, one part of the support parts of
The insertion structure of the above example is arranged substantially longitudinally; in another example, a lateral insertion structure may also be provided on the solid object, and inserted into a gap in the support part, pores in the first porous structure 10, etc., to secure the solid object. For example, the holding space 429 of
In some examples, the support part is inserted in a gap formed at the first porous structure 10, which has a gap between the support part and its surrounding first porous structure 10; a hoop structure matching said support part or an insertion structure (e.g., a hollow column) matching said gap is formed at the contained substance (or capsule, edge interface of the solid object of the holding space, etc.); the hoop structure of the contained substance, etc., can be placed over said support part or the insertion structure can be inserted into said gap after completing resistance welding. If the hoop or insertion structure achieves a tight fit, then the contained substances, etc. can be secured thereby; otherwise, they can be secured when in conjunction with other components of the connected structure (e.g., the support part, the first porous structure 10, etc.). For example, the contained substances may be located on the top surface of the first porous structure 10 (next to the support) and further carried or connected by the top surface of the first porous structure 10 (the top surface may remain flush or form a downward recess to hold the contained substances), or the contained substances, etc. may be suspended without contacting with the top surface of the first porous structure 10.
For example, the bottom of a solid object 61 of
In addition, although
In some examples of implementing resistance welding, a first polar electrode, proximal to the side of the first porous structure 10, contains one or more electrode segments. Said electrode segments may be inserted into the gap formed within the first porous structure 10 in direct contact with an intermediate interlayer portion (e.g., intermediate body 20, raised structure 21, intermediate body 20 with raised structure 21, etc.) exposed within the gap; alternatively, the gap is not directly connected to the interlayer portion, but a portion of the first porous structure 10 remains at the bottom of the gap, and the segments of electrodes are in direct contact with this part of the first porous structure 10 is in direct contact (not shown in the figure), so that the current is conducted through this part of the first porous structure 10 to the interlayer of the intermediate. The electrode segment may be in contact with the first porous structure 10 next to the gap into which it is inserted, or it may be separated by the gap or insulator.
As shown in
Alternatively, said electrode segment may also be inserted into a gap formed within the support part in direct conductive contact with the support part (which may have a top surface higher or lower than or equal to the top surface of the first porous structure 10, with the gap of the support part recessed downward from the top surface of the support part). The intermediate of this example may contain only the support part or may contain both the support part and the interlayer (e.g., intermediate body 20, raised structure 21, intermediate body 20 with raised structure 21). It is allowed to have a part of the first porous structure 10 between the support part and the intermediate, or between the support part and the substrate 30. More preferably, it is made to have a direct conductive contact between the support part and the intermediate to conduct the electric current.
A plurality of the electrode segments 409 are as shown in
In each of the above examples, there is no or a small amount of electrical current flowing through the first porous structure 10 so as to, improve the conductive efficiency and also avoiding thermal damage to the exposed surface of the first porous structure 10. After completion of resistance welding, the inserted electrode segment 409 or conductive medium 4011 is removed, leaving gaps 108 located within the first porous structure 10 (
Although the examples are described in terms of insertion of the electrode segment from the top, it is understood that if the electrode segment is inserted into the first porous structure 10 from other directions (e.g., the side) or into a gap in the support part (opened sideways), both the implementation of resistance welding and the use of the gap to place an contained substance or its insertion structure are also possible.
The variation examples in this Embodiment and the characteristics of the holding space or the contained substances associated with them can all be applied to other Embodiments.
As shown in
The support part 80 in the figure is still exemplified by the support post. The support part 80 corresponds to and contacts raised structures 21 of the interlayer, which also contains the intermediate body 20.
A coupling part 981 or extension part 982 can be provided on the support part 80 to build the edge interface of the holding space, or it can be used directly to secure (carry, connect, tightly fit or limit, etc.) the contained substance (or its capsule). Each coupling part 981 is connected to two support parts 80 at each end. Each extension part 982 is connected to the support part 80 at one end and may extend to other components (such as the first porous structure 10) at the other end or be open at the other end.
For example, the coupling part 981 of
The coupling part 981 or extension part 982 may also be in contact with or connected to other components of the connected structure, such as the first porous structure 10 supported from below; alternatively, the coupling part 981 or extension part 982 may be suspended, such as where the first porous structure 10 at the corresponding location is removed and the coupling part 981 or extension part 982 is not in contact with the first porous structure 10, for example (and instead relies on the connected support part).
As shown in
The shape, size and quantity of the coupling part 981 or extension part 982 are not limited, and can be in the form of a plate, strip, rod, etc. If it does not affect the placement or use of the contained substances, or channel or opening of the holding space so formed, then the space above coupling part 981/extension part 982 can be hollowed out, or there can be a gap between adjacent coupling part 981/extension part 982 corresponding to the same edge interface.
One coupling part 981 (or extension part 982) may correspond to the edge interface of the holding space on its one side, covering all or part of the area corresponding to that side edge interface; or, multiple coupling parts 981 (or extension parts 982) may simultaneously correspond to one side of the edge interface of the holding space, cooperatively covering all or part of the area corresponding to the edge interface on that side (multiple coupling parts 981/extension parts 982, covering part of the area, may be spaced apart or close to each other without spacing). The coupling part 981 and the extension part 982 may be provided at the same time or at different time; may be located at the edge interfaces on the same side or at different edge interfaces; may be connected to the same support part 80 or to different support part 80.
Exemplarily, the two support parts 80 connected to each end of the coupling part 981 may be located at two adjacent or oppositely oriented edge interfaces within the holding space. And between two support parts there could be one or multiple coupling parts 981. Exemplarily, two extension parts 982 of the same edge interface of a holding space may be provided at the same or different heights, and the respective ends of the two extension parts 982 that are not connected to the support part 80 may be close to or apart from each other at a distance.
For example, the coupling part 981c shown in
The coupling part 981/extension part 982 may be integrally formed with the support part 80, or the coupling part 981/extension part 982 may be an additionally provided component (separately formed and connected to the support part 80, provided prior to securing the contained substance, etc.). Other Embodiments of the wall plate, filling surface, polymer material layer, barrier plate, etc. all can be used as the coupling part 981/extension part 982. If set prior to the resistance welding implementation, it is preferred to use a conductive material (e.g., solid object or high solid volume fraction porous structure) to make the coupling part 981/extension part 982.
An example holding space, as shown in
An example holding space, as shown in
The extension part 982 in this example can be constructed from a part of the intermediate body 20; or it can be a separately provided part, of which the material, thickness, height from the substrate 30, etc. can be the same or different from the intermediate body 20. The extension part 982 shown in
After a suitably shaped and sized contained substance is placed in the holding space. Its edge can be carried by the extension part 982 so that it does not fall off, or it can be further fixedly connected to the extension part 982 if needed (
For example,
An example holding space, as shown in
For example, the holding spaces 466 and 467 shown in
In each of the above examples, in addition to forming the channel or opening for the holding space in one of the coupling part 981/extension part 982 (or support part 80), it is also possible to not install one of the coupling part 981/extension part 982 (or support part 80) in its designed position, leaving the designed position as a channel or opening for placing the contained substance, and then the coupling part 981/extension part 982 (or support part 80) can be installed in place to close the channel or opening.
For the three examples of
For the three examples in
In this Embodiment, the support part 80 with the coupling part 981 or extension part 982, and the characteristics of the holding space or contained substance associated with it, can be applied in other Embodiments.
As shown in
When using laser welding, the welding position between the intermediate of the composite and the substrate 30 is not specifically limited, and at least one pair of contact surfaces can be selected for welding according to the application needs. As an example, intermediate body 20 contains a bottom, which can be any shape and size, a porous structure or solid object with a higher solid volume fraction than the first porous structure 10, the bottom of the intermediate body 20 in
Based on the example of
To this end, the periphery of the intermediate body 20 is accordingly provided with an inclined bevel 221, which also has a set angle (preferably acute) with the bottom of the intermediate body 20; thus, when the composite of the first porous structure 10 and the intermediate body 20 is set in the recess, the inclined periphery (bevel 221) of the intermediate body 20 is able to fit with the inclined sides (bevel 321) of the recess of the substrate 30; The bottom and periphery of the intermediate body 20 are in contact with the top and side surfaces of the recess of the substrate 30, and are welded and fixed at these contact surfaces respectively. The present invention does not specifically position-limit the location, welding position, shape (e.g., change to curved surface, arc, etc.), and size of the contact surface between the intermediate body 20 and the substrate 30 (or its recess), and can be designed according to the actual application.
Based on the example of
The position-limiting protrusion 222 in the snap structure shown in
The bevel structure and snap structure of the contact part between the recess of the substrate 30 and the intermediate body 20 in the above multiple examples can be provided individually or cooperatively. These structures are collectively referred to as positioning structures, mainly to ensure that the two can fit tightly together without displacement when welding the substrate 30 to the intermediate body 20; and also to serve as a secondary fixation after the welding is completed.
In this Embodiment, the positioning structures such as bevels or position-limiting ports at the contact surfaces of the substrate 30 can be integrally formed with the substrate 30, or formed subsequently by machining after the substrate 30 has been formed. Preferably, the intermediate body 20 is pre-connected or integrally formed with the first porous structure 10. Preferably, the positioning structure such as a bevel or position-limiting protrusion at the contact surface of the intermediate body 20 is integrally formed with the rest of the intermediate body 20, using 3D printing or other processes (without limiting that, in some examples, the structure such as a bevel or protrusion is formed by certain machining means after the intermediate body 20 body is formed).
When the holding space is provided with the connected structure of each of the above examples, at least a portion of each of the holding spaces 444 to 449 is opened within the first porous structure 10 as shown in
In some examples, the notch formed at the bottom or periphery of the intermediate body 20 does not extend through such that the edge interface in the corresponding direction of the holding space is located inside the intermediate body 20; or, the bottom or periphery of the intermediate body 20 extends through such that the edge interface of the holding space extends further to the top or side of the recess of the substrate 30 (e.g., the intermediate body 20 adjacent to the holding space 446).
When the bottom or periphery of the intermediate body 20 is used as an edge interface, or, when the top surface or side surface of the recess of the substrate 30 is used as an edge interface, the contained substances or its capsule can be fixed (carried, connected, tightly fitted, limited, etc.) alone or in conjunction with an edge interface in other directions. A channel or opening for the holding space can be opened at the bottom or periphery of the intermediate body 20, the top or side of the recess of the substrate 30, etc. (e.g., arrow 77 of
The aforementioned holding space or the setting of the channel/opening therein may avoid the location where the positioning structure (corresponding bevels on the contact surface or matching protrusions and position-limiting openings, etc.) is located. Alternatively, the aforementioned holding space or the setting of the channel/opening therein may be allowed at a part of the positioning structure if it does not interfere with the use of other positioning structures. Alternatively, if the positioning structure mainly functions during the welding process, then if the holding space or the channel/opening therein is set after welding, the position of the positioning structure may not be avoided or the positioning structure may be further used to set the edge interface of the holding space or to open the channel or opening of the holding space.
In this Embodiment, the structure of the bottom/periphery of the intermediate body 20 mating with the top or side of the recess of the substrate 30, and the characteristics of the holding space or contained substance associated with it, can be applied in other Embodiments.
As shown in
For the preceding Embodiment VII, the intermediate contains substantially the bottom (or both the bottom and the periphery), and the bottom is substantially a sheet or a plate; the shape and size of an intermediate (or multiple intermediates when combined) may be substantially the same as the shape and size of the connection area on the substrate; the connection area of the intermediate to the substrate is welded such that the first porous structure forming a composite with the intermediate covers the connection area of the substrate. The intermediate is welded to the connection area of the substrate so that the first porous structure forming a composite with the intermediate covers the connection area of the substrate and constitutes the exposed surface at the connection area.
The main difference from Embodiment VII is that in the connected structure between the first porous structure and the substrate described in Embodiment VIII, the intermediate between the first porous structure and the substrate is in the form of anchor points, and the first porous structure and a plurality of anchor points are formed into a composite body, and the composite body is connected to the substrate by welding the anchor points to the substrate. In this Embodiment, the anchor points can be solid object or porous structure with higher solid volume fraction.
Each freestanding anchor structure 200 illustrated in
Each freestanding anchor structure 210 illustrated in
In this example, there is a gap 114 above the bottom of the anchor point and in the space enclosed by the periphery, which does not form the first porous structure 10; the welding operation is carried out in said gap 114, and the bottom of each freestanding anchor point structure 210 is welded to the top surface of the recess of the substrate 30 at the corresponding position to achieve a reliable connection between the composite body and the substrate 30. The periphery or bottom of the freestanding anchor structure 210 corresponds to an edge interface of the holding space, allowing the opening of a channel or an opening therein.
Preferably, the examples of
The examples of
For example, the contained substance may be located on the top surface of the first porous structure 10, may be further carried or connected by the top surface of the first porous structure 10 (the top surface may remain flush or form a downward recess to hold the object), or, solid objects such as contained substances may be suspended without contact with the top surface of the first porous structure 10. There is no pre-formed gap in
In each of the above examples, the freestanding anchor structures 200, 210 are not provided at the edge of the composite; the first porous structure 10 at the edge is located between the periphery of the corresponding freestanding anchor structure 210 and the side of the recess of the substrate 30, and is in direct contact with the side of the recess of the substrate 30 (it is possible to keep only the contact between the two (
For the above-mentioned freestanding anchor structure, several intermediates in the form of anchor points are independent of each other and form a composite with the first porous structure; the shape and size of a composite (or multiple composites when combined) can be substantially the same as the shape and size of the connection area on the substrate; the freestanding anchor structure is welded to the corresponding points of the connection area of the substrate so that the composite covers the connection area of the substrate, (mainly with the first porous structure) constitutes the exposed surface of the connection area.
In this example, the first porous structure is connected to the substrate, and the intermediate between the first porous structure and the substrate uses a jointed anchor structure, i.e., a plurality of anchor points are included, and each anchor point is interconnected with at least one other anchor point by a joint body. The first porous structure is shaped into a composite with the anchor points and their coupling parts, and the composite is connected to the substrate by welding of the anchor points to the substrate.
The anchors may be of the same material as the anchors and may be of the same or different form; the anchors may be solid object or a porous object with higher solid volume fraction than the first porous structure; the coupling part between the anchors may be solid object or a porous object with higher solid volume fraction than the first porous structure; the anchors and the coupling part may be of the same or different solid volume fraction when both are porous. The anchor point and the coupling part are preferably formed in one piece by 3D printing or other means; however, without limitation, in some examples, the two are formed separately (supplemented by machining) and then combined together.
In the linked anchor structure illustrated in
Then, based on the examples of
Another example is shown in
Each coupling part in
In turn, the sidewall 252 of the coupling part may serve as an edge interface on one side of the holding space (as in one of the sidewalls 252 of
Preferably, each example uses laser welding (with the adjacent anchor points shown in
In the examples of
As a variation, it is possible, in some other examples, to have at least part of the anchor point and/or at least part of the coupling part of the linked anchor point structure set to the edge part of the composite; when the anchor point with periphery/the coupling part with sidewall are at the edge part, the periphery of the anchor point/the sidewall of the coupling part, may directly contact the sidewall of the recess of the substrate; or, welding points may be added between them, or, further, a positioning structure such as a matching bevel and/or snap can be provided between them (see Embodiment I). In addition, the linked anchor point structures in the illustrations are all located at the bottom of the composite body, while in some examples, a number of linked anchor point structures may be provided individually or cooperatively at the periphery of the composite body (e.g., touching the side surface of the recess of the substrate).
Then, based on the linked anchor point structure with peripheral anchor point/coupling part with sidewall, the side surface of the recess of the substrate, the methods of forming the holding space, placing contained substance and setting the channel/opening can refer to the mating structure of the bottom/periphery of the intermediate with the top or side surface of the recess of the substrate as described in Embodiment VII.
In this Embodiment, the freestanding anchor structure or the linked anchor structure, and the characteristics of the holding space or the contained substance associated with it, can be applied in other Embodiments.
The contained substances in this example is a sensor, and the holding space can use any of the structures and arrangements described in the Embodiments above. The type of sensor is not limited and the applicability is not limited; for example, it may be a mechanical sensor, a molecular sensor, a chemical sensor, a biochemical sensor, etc. The descriptions of the types of sensors and the selection of their modules, the structural arrangement of the holding space and the design of the channels in this Embodiment are schematic and are not meant to be limiting.
In conjunction with
In the case of the connected structure that connects a substrate to a composite containing a first porous structure and an intermediate for use in forming a prosthetic implant for implantation in the human body, as described in each Embodiment, the sensor may preferably be a temperature sensor to obtain the temperature of the human body near the implantation site. The temperature around the prosthetic implant will increase when it is infected, and the temperature sensor can detect temperature change and give an warning.
The sensor may be with an electrical energy storage elements (e.g., some kind of battery) that maintains its supply of electrical energy during standby and/or use.
Alternatively, the sensor can be with a receiving coil and the necessary auxiliary components (for conversion, transmission, etc.) that work with an external feeding coil to obtain electrical energy via wireless charging technology and transmit it via lines to the electrical energy storage elements or to the core sensing element of the sensor.
Alternatively, the sensor is connected to a conductive wire, which can be threaded through the pores of the first porous structure; or, between raised structures under the intermediate body; or, through a channel or opening in one or more of the parts including intermediate body, support part, coupling part; and, substrate. The channels on the intermediate body and/or the substrate can be in the form of unenclosed grooves or can be pipes with openings only at the input and output ends. Depending on the actual arrangement of the conductive wires, a combination of the above can be used.
The conductive wire input terminal can be connected to an energy storage and power supply device, which can be located at the substrate, at another holding space, or a separate device implanted in the body, etc., or a device located outside the body; or, the conductive wire input terminal is formed with an interface, which is located on the body surface and connected to an external power source when charging or power is required. In addition to power supply, the above wire arrangement can also be analogous to the arrangement of the signal transmission wire, and the two wires and their channels can be independent of each other or shared. This Embodiment can be further extended to the case where the contained substances are various other power-consuming devices.
The holding space is opened with channels or openings connected to the outside, and the probe of the sensor can be directed to some of these channels or openings. Alternatively, in conjunction with
In another example, in conjunction with
In this Embodiment, the sensor and the holding space in which it is housed, as well as the features associated with it such as the substrate, the intermediate, and the first porous structure in the connected structure, can be applied in other Embodiments.
The contained substance in this example is a drug. There is no limit to the type of drug and no limit to its applicability. In each of the above examples, the structure and arrangement of the holding space having a channel or opening connected to the outside can be applied in the present Embodiment. The description of the drug form, the structural arrangement of the holding space and the design of the channel in this Embodiment are schematic and are not intended as limitations.
An example of the connected structure is a prosthetic implant implanted in the body that can be used to prevent or treat infection around the prosthetic implant by means of a drug placed in the holding space. Channels or openings are provided at the holding space to insert the drug into the space and/or to release the drug; the drug input and output channels (output and input ports) may be independent of each other or may be shared. The direction, location and size of each channel/opening can be determined according to the actual application without limitation.
Exemplarily, the holding space contains the support part, the coupling part between the support parts; as shown in
Exemplarily, the delivery channel/output port of the drug may be opened on the first coupling part 981a, such as being a number of through holes 78 on the first coupling part 981a, whereby the released drug is diffused through the first porous structure 10 above the first coupling part 981a and delivered to a body part closely connected to the first porous structure 10. Of course, depending on the application, the delivery channel/output port of the drug can also be opened on the second coupling part 981b, such as a number of through-holes 79 on the second coupling part 981b (released via the direction where the intermediate body 20, the substrate 30 is located), or on the support part 80 or other coupling part (released drug via other directions).
Exemplarily, the input channels/input ports for the drug may be provided on the first coupling part 981a or the second coupling part 981b, for example, a number of through holes 78 or 79 on the corresponding coupling part; the input channels/input ports may also be provided on either the support part 80 or other coupling part as desired. In some examples, the through-hole 78 on the first coupling part 981a serves as both an input channel/input port and an output channel/output port (see
As shown in
Therein, the raised structure 21 of
If the drug is required to be released continuously for a short period of time after insertion, the holding space may be not closed, with the output channel/port for release always open. Alternatively, if the drug is not released immediately after insertion, the holding space needs to be relatively closed and the input channel/port and output channel/port can be closed. For example, the openings of the input channels are closed after drug has been delivered (the closure bodies can be temporary or permanent), and the openings of the output channels can be temporarily closed and will open when needed to release the drug.
The closure bodies for closure include a variety of structures such as corks, plugs, films, etc. The closure bodies can be made of the same material (thickness, etc., can also be similar) as the components (coupling part, support part, intermediate body, etc.) next to the opening; the closure bodies can be part of these components, divided to form the opening, and then closed up after the drug placement. Alternatively, the material, thickness, etc. of the closure bodies can be unrelated to the components next to the opening, and can be chosen as needed.
For example,
In some preferred examples, the closure bodies may be made of a material that self-triggers to open after certain conditions are met, such as a change in temperature, pressure, humidity, for example, due to an infection around the prosthetic implant, or an artificial adjustment of the condition around the prosthetic implant by a physician, etc.); or, the material of the closure bodies may degrade after a certain period of time; or, the material of the closure bodies may react with a substance to open up (e.g., the substance that triggers the reaction is self-generated by a peri-prosthetic lesion, or may be injected by a physician when a drug release is required), so that the drug release can be controlled according to the different needs of the actual application.
As shown in
Exemplarily, the drug may be inserted after the composite and the holding space therein are formed (assuming that the drug properties are not affected by the connection of the composite to the substrate). Alternatively, the drug may be inserted after the composite is connected to the substrate. Alternatively, the drug may be inserted during the surgical procedure for prosthetic implantation, as needed. Assuming that the position of the opening of the input channel to the holding space or the entrance to the transmission channel on the substrate is fixed or can be located by auxiliary detection means, the physician can inject the drug into the holding space by using a syringe or the like to inject the drug into the opening of the input channel or the entrance to the transmission channel, or, for example, after the prosthetic implant implantation procedure, to determine whether to place the drug or to replenish the released drug as needed. The drug can be replenished as needed. The release of the drug is used to treat lesions such as infections around the prosthetic implant. The rate of drug release can be controlled by designing the shape, number, and diameter of the output channels/ports.
The drug can be liquid; the need for closing the holding space can be determined based on release requirements. Assuming that the size of the drug at the time of insertion is larger than the opening of the output channel, it will not be released immediately after insertion. When certain conditions are met (e.g., dissolution by heat, liquid, etc., degradation over time, etc.), the solid object form of the drug will change (particle size becomes smaller or turns to liquid) and can be released from the output port to act on the surrounding area of the prosthetic implant. etc.) and can be exported from the output port to act on the area around the prosthetic implant. Alternatively, the drug (liquid, powder, etc.) can be externally covered by a coating (e.g., capsule, shell, etc.) to form a relatively stable solid object form, and the space or channel/opening can be set with reference to the structure described in the preceding Embodiments. The coating body itself is opened with through release channels and then the drug is released through the release channels or open boundaries of the holding space.
In combination with the contents of Embodiment IX and Embodiment X, in some examples, the sensor and the drug can be provided in the same holding space of the prosthetic implant, and can be provided in different holding spaces or in the same holding space. Then, when it is determined that the drug needs to be released based on a certain status information detected by the sensor, the drug is released using the various means described above.
Wherein, the device used to judge the status information, for example, is some kind of processor, which can be integrated with the sensor or can be set up separately, and the power supply can be referred to the power supply of the sensor; the processor can be set in the same holding space where the sensor or the drug is located, or in a different holding space, and can also be set outside the body; the processor and the sensor can be connected by wire; the processor and the sensor can be connected by a wire, or the information can be transmitted by wireless transmission, etc.
After determining the need for release, it can be a manual operation to perform the drug release. Alternatively, some trigger device may be further provided at the prosthetic implant for releasing the drug. The trigger device may be located within the holding space where the drug is located, or within another adjacent holding space, or provided somewhere outside the holding space where the drug is located. The trigger device action can act on the closure bodies itself to open the channel or opening of the holding space, or, alternatively, can change some state around the holding space, the closure bodies or the drug so that the trigger condition for the closure bodies to trigger itself to open and the drug to release itself is satisfied. For example, after determining the need to release the drug, a processor, sensor or in vitro device, etc., can give instructions to the trigger device (by wire or wireless means) to drive the trigger device to act.
Alternatively, the release of the drug may be timed. For example, a timer is used to time (or count down) the drug release, and when a specified time is reached, a command is sent to the trigger device to actuate the trigger device to enable the drug to be released. Said timing, including a defined point in time, and/or, a defined time interval, is arbitrarily set according to the needs of the specific application. For example, the drug is released at several specific points in time each day; for example, the time interval between each two releases of the drug can be set to be the same or different; there is no limitation on the unit of the time interval, it can be a number of minutes, hours, days, months, years, and so on. The timer, or timing device, may be stand-alone (a device located inside or outside the body) or may be implemented by a module built into the processor. Similarly, it can be timed to control the sensor to initiate detection and, based on the results of the detection, to determine whether a drug release needs to be triggered.
For example, the trigger device can puncture the film used for the closure bodies, the capsule wrapped around the drug, etc.; or, the trigger device can remove the closure bodies (and can reliably fix the removed closure bodies), or push the closure bodies into the holding space (the closure bodies to be pushed in does not easily leave the holding space, or does not interfere with the release of the drug or the subsequent use of the prosthetic implant), and the channel/opening is opened; or, the trigger device can change the temperature, pressure, humidity and other states around the closure bodies or drug, or can spray a liquid or deliver a substance that can react with the closure bodies or drug to meet the conditions of the closure bodies or drug capsule trigger to open, or make the drug itself change its form and suitable for release.
For example, the drugs to be released at different times can be located in different holding spaces, or in different locations in the same holding space, separated or wrapped with the corresponding covering body respectively; each time the specified time arrived, the trigger device will open up the holding space or covering body. Each time when the trigger device is used, it can be the same trigger device, or a different one. Trigger device can be for single-use, or is re-usable.
In this Embodiment, the drug and its placement and release in the holding space, the sensor, and the features associated with it such as the substrate, the intermediate, and the first porous structure in the connected structure, can be applied in other Embodiments.
This Embodiment provides a prosthetic implants, preferably an orthopedic prosthetic implant; any one or more of the connected structures of Examples I through VIII and their respective variant examples described above may be used, and the sensors or drugs described in Embodiment IX or Embodiment X are provided in the holding spaces of these connected structures.
In the preferred example, the body of the prosthetic implant corresponds to the substrate in the connected structure, and at least a portion of the surface of the body of the prosthetic implant serves as the connection area to the composite containing the intermediate and the first porous structure, and at least a portion of the surface of the first porous structure becomes the exposed surface of the prosthetic implant by the connection (preferably welding) of the composite to the substrate.
A connected structure can be provided with one connection area to the substrate, or a plurality of connection regions connected or separated; the structure of the intermediate at each connection area can be the same or different, the connected structure of the composite to the substrate can be the same or different, and the structure for providing the holding space or the contained substance can be the same or different.
The artificial hip joint is used as an example. The artificial hip joint contains a femoral stem, a femoral ball head (not shown), an acetabular cup, and a liner (not shown), all of which are prostheses made of medical materials that can be implanted in the human body, for example, metallic materials such as titanium, cobalt-chromium-molybdenum alloy, ceramics, polymers such as ultra-high molecular weight polyethylene, and are not limited to these.
As shown in
The other end of the head of the femoral stem 600 is inserted into an inner taper mounting structure to the femoral ball head; as shown in
In some examples, the inner side of the acetabular cup 700 has a number of recessed structures 702 (see
In this regard, the use of porous structures on the upper (proximal) surface of the stem 600 and the peripheral surface of the acetabular cup 700 can, on the one hand, increase the roughness and help the prosthetic implant achieve effective initial stability in the skeletal host site; on the other hand, it can induce osteoblastic bone to grow in, which in turn effectively connects the femoral stem 600 to the femur and the acetabular cup 700 to the acetabular notch in a fixed manner, forming a good long-term biological fixation. Enhance the stability of the interface between the artificial hip joint and the host bone tissue.
Based on the structure and method of Embodiments I to VIII or variations thereof described above, a partially enlarged side sectional view at box line E of
The stem body 630 is adapted to the stem housing 650 (or intermediate 620 contained therein) at the site of contact and connection. Exemplarily, depending on the manner of welding, the intermediate 620 of the stem housing, contains an interlayer (e.g., intermediate body and/or raised structure), and/or a support part (e.g., support post); alternatively, the intermediate 620 contains a bottom (or contains a bottom and periphery), and may also use a freestanding or coupled anchor point structure. The connection area of the stem body 630 may be provided with a recessed portion set in the stem housing 650 or a portion of the housing; or the stem body 630 may have no recessed portion and have the stem housing 650 wrapped directly outside the connection area of the stem body 630 (
The stem body 630 is made by forging, casting, powder metallurgy or machining, preferably of solid structure for easy processing and high strength; or stem body 630 can be a high solid volume fraction porous structure; intermediate 620 can be solid object or a porous structure with higher solid volume fraction than the first porous structure 610; when both stem body 630 and intermediate 620 use porous structures, the solid volume fraction of the intermediate 620 is between that of the stem body 630 and that of the first porous structure 610. The intermediate 620 and the first porous structure 610 of the stem body 650 are preferably realized by using 3D printing additive manufacturing process, which can well form the pores according to the design requirements, etc. The composite body with intermediate 620 at stem body 630 and stem body shell 650 is effectively connected by welding, avoiding the current problem of significant reduction in overall strength when the porous structure is connected on the surface of the femoral stem by a hot pressing process (e.g., diffusion welding process), etc.
In a specific example, the upper (proximal) part of the stem body 630 of the femoral stem 600 is provided with an connection area; the side of the head and neck of the femoral stem 600 arranged at an angle is the medial side of this femoral stem 600, and the posterior, lateral, and anterior sides of the stem body 630 are arranged in a counterclockwise direction as illustrated in
In this example, the connection region of the femoral stem 600, corresponding to the stem body 630 comprises a portion of the surface of the upper (proximal) portion of the stem body 630 corresponding to the medial, posterior, lateral, and anterior surfaces. As shown in
The two shell pieces may be symmetrical (or they may be staggered and crossed, not shown). Exemplarily, the adjacent edges of both shell pieces may be separated from each other without being connected after forming and assembling. Alternatively, the adjacent edges of one side of the two shell pieces (e.g., the adjacent edge corresponding to the outer side) may be connected at the time of forming and may remain connected while there is some bending near the adjacent edge (to bring the two shell pieces together). Alternatively, the two shell pieces may be formed with the adjacent edges separated from each other and the adjacent edges on each side are connected (e.g., by welding or using connectors or other means of connection) after they are brought together. By adjacent edges is meant the edges adjacent to each other after the two shell pieces are brought together. The interconnection of the adjacent edges may be to the intermediate 620 and/or the first porous structure 610 of the outer layer within each shell sheet.
The porous structure of the peripheral surface of the acetabular cup can be similarly achieved using the structures and methods of Embodiments I to VIII above or variant examples thereof. As shown in
The cup body 730 of the acetabular cup 700 is adapted to the composite (or intermediate 720 contained therein) at the site of contact and connection. The cup body 730 may be provided with a recessed portion of the composite body or part thereof set in the connection area of the cup body 730, or the cup body 730 may be provided without the recessed portion, with the composite body wrapped directly outside the connection area of the cup body 730; the part of the cup body 730 in contact with the intermediate 720 may be further provided with a positioning structure such as a bevel and/or a snap.
The cup body 730 of the acetabular cup 700 is made by forging, casting, powder metallurgy, or machining, and is preferably a solid structure for ease of machining and high strength; or the cup body 730 may be a high-solid volume fraction porous structure; the intermediate 720 may be solid object or a porous structure with higher solid volume fraction than the first porous structure 710; the cup body 730 and the intermediate 720 use a porous structure, and the solid volume fraction of the intermediate 720 is between that of the cup body 730 and that of the first porous structure 710. When both the cup body 730 and the intermediate 720 use porous structures, the solid volume fraction of the intermediate 720 are between the solid volume fraction of the cup body 730 and the first porous structure 710. The intermediate 720 and the first porous structure 710, preferably achieved using a 3D printing additive manufacturing process, can well control the pores, etc., to meet the design requirements. The cup body 730 and the composite body with intermediate 720 are effectively connected by welding, avoiding the current problem of significant reduction in overall strength through hot pressing processes (e.g., diffusion welding process), etc.
In a specific example, as shown in
The fusion cage device is used as an example for illustration. In the presence of spinal injuries, such as degenerative disc disease with symptoms such as lumbar disc herniation and cervical spondylosis, in order to strengthen the spine between the two vertebrae involved in the injury, a fusion cage is typically placed between two directly overlapping vertebrae after removing the injured disc from the intervertebral cavity or disc space in order to maintain a predetermined distance between the vertebrae and to allow the fusion to eventually integrate into the intervertebral space and Improves intervertebral stability.
As shown in
The fusion cage body 8300 acts primarily as a mechanical support; and in order to promote bone ingrowth and accelerate the bony fusion of the upper and lower vertebrae with the fusion cage, the first porous structure 8100 can preferably cover the upper, lower end faces of said fusion cage body 8300; or, further, at least part of the outer surface of the sidewall of the fusion cage body 8300, and/or at least part of the inner surface at the sidewall (around the longitudinal/transverse through-holes) are also covered with the first porous structure 8100. With the connected structure and method of the present invention, it is possible to achieve a larger coverage area of the porous structure 8100 on the surface of the fusion cage 8000 without affecting the structure or strength of the fusion cage body itself.
To this end, the structures and methods of Embodiments I to VIII above or variant examples thereof can be used similarly in said fusion cage device 8000. A partially enlarged side sectional view at box line E of
The fusion cage body 8300 mates with the composite (or its intermediate) at the site of contact and connection. Exemplarily, the intermediate may contain an interlayer and/or a support part, or may contain a bottom (or contain a bottom and a periphery), and may also use a freestanding or linked anchor structure; the connection area of the fusion cage body 8300 may be provided with a recessed portion in which the composite or a portion thereof is placed; or the fusion cage body 8300 may have no recessed portion, with the composite directly overlying the connection area of the fusion cage body 8300 The fusion cage body 8300 may be further provided with a positioning structure such as a bevel and/or a snap where a part of the fusion cage body 8300 is in contact with the intermediate.
The fusion cage body 8300 is made by forging, casting, powder metallurgy or machining, preferably as a solid structure, which is easy to machine and has high strength; or the fusion cage body 8300 can also be a porous structure with a high solid volume fraction; the intermediate can be a solid object or a porous structure with a higher solid volume fraction than the first porous structure 8100; When both the fusion cage body 8300 and the intermediate use porous structures, the solid volume fraction of the intermediate is between that of the fusion cage body 8300 and the first porous structure 8100. The intermediate and the first porous structure 8100 are manufactured, preferably using a 3D printing additive manufacturing process to effectively control the pores, etc., to meet the design requirements. The fusion cage body 8300 is effectively connected to the composite body containing the intermediate with the welding process, avoiding the current problem of significant reduction in overall strength by hot pressing processes (e.g., diffusion welding process), etc.
The artificial knee joint is used for illustration. The knee prosthetic implant consists of femoral condyle and tibial tray (both often metallic), an insert set between the two (which can be made of polyethylene etc), and the patellar component. The femoral condyle is connected to the distal femur and the tibial tray to the proximal tibia. The lower part of the insert is in contact with the upper surface of the tibial tray, and the convex surface of the femoral condyle is in contact with the upper part of the insert and the articular surface of the patellar component, allowing for flexion, extension, sliding, rotation and other activities within a defined range.
Referring to femoral condyle 900 shown in
The outer convex surface of the femoral condylar body 930 is usually smooth to reduce wear with the insert; while the inner concave surface of the femoral condylar body 930, preferably a porous structure, will match and contact with the cut surfaces of the distal femur, with host bone growing into the pores to achieve a strong bond between the implant and host bone, thereby improving the mechanical stability and biological compatibility of the implant.
Exemplarily, at the femoral condyles 900, in view of the presence of the condylar surface and the intercondylar notch 907, the inner concave surface of the femoral condylar body 930 can be divided into a plurality of regions, such as: the superior end region and anterior region, corresponding to regions 901, 902, respectively, where there is no left/right division; the central, posterior and posterior end regions 903, 904, 905, each having left and right halves. Within each of these regions, there provides the first porous structure 910. Regions 901-905 may be independent of each other or inter-connected; the first porous structures 910 located in these regions 901-905 may be independent of each other or inter-connected.
To this end, for the said femoral condyle 900, the structure and method of Embodiments I to VIII above or variant examples thereof can all apply. As shown in
Shown in
To this end, for the said tibial tray 1000, the structure and method of Embodiments I to VIII above or variant examples thereof can be similarly used. In
The femoral condylar body or tibial tray body, as described above, mates with the respective composite body (or its contained intermediate) at the site of contact and connection. Exemplarily, the intermediate may contain an interlayer and/or support part, or the intermediate may contain a bottom (or contain a bottom and periphery), and may use a freestanding or linked anchor structure; the connection area of the femoral condylar body/tibial tray body may be provided with a recess in which the composite body or a portion thereof is placed; or the femoral condylar body/tibial tray body may have no recess, with the composite body directly overlying the femoral condylar body/tibial tray body. The femoral condyle body/tibial tray body may be provided with a bevel and/or a positioning structure such as a snap at the location where the femoral condyle body/tibial tray body is in contact with the intermediate.
The femoral condylar body/tibial tray body is made by forging, casting, powder metallurgy or machining, preferably as a solid structure for ease of processing and with high strength, or a porous structure with high solid volume fraction; the intermediate may be a solid object or a porous structure with a higher solid volume fraction than the first porous structure; When both the femoral condylar body/tibial tray body and the intermediate use porous structures, the solid volume fraction of the intermediate is between that of the femoral condyle body/tibial tray body and that of the first porous structure. The intermediate and the first porous structure are preferably made by using 3D printing additive manufacturing process, which can effectively control the pores and curvatures, etc. to meet the design requirements. The femoral condyle body/tibial tray body and the intermediate are effectively connected by welding, avoiding the current problem of significant reduction in overall strength through hot pressing processes (e.g., diffusion welding process), etc. The patellar prosthetic implant can likewise use the structures and methods of Embodiments I through VIII above or variations thereof to add porous structures to its bone-contacting surface.
Based on the description of the present Embodiment, the structures and methods of Embodiments I to VIII, or variations thereof, can be widely used in any other types of orthopedic prostheses, including artificial joints and other prosthetic implants.
Examples are spinal prostheses, ankle joints, shoulder joints, elbow joints, finger joints, toe joints, facet joints, temporo-madibular joints, wrist joints, and so on; the present invention allows the first porous structure, which is pre-connected or integrally formed to the intermediate, to cover the surface of the connection area on the prosthetic implant body by making contact with the intermediate and welding it to the connection area. (The basic structure and working principle of the various prosthetic bodies can be achieved by referring to the prior art in the field and will not be discussed here).
In addition, for any of the prostheses, after completion of the connection of the composite to the substrate, on the bone-contacting surface of the prosthetic implant, including but not limited to the first porous structure of the prosthetic implant, a coating or a carrier may be provided: an osteoconductive or osteoinductive coating (e.g., hydroxyapatite (HA)) formed by spraying or other means; a carrier containing cells/growth factors (e.g., using materials such as gel/collagen as carriers), or containing antimicrobial agents (e.g. antimicrobial agents/silver ions), etc.
Optionally, certain edges of the composite body described herein may form a seal to the edge of the intermediate, to the edge of the first porous structure, or to the edge at the junction of the two (not shown). Said edges may be solid or porous structures with a higher solid volume fraction than the first porous structure. Each edge may be a continuous section or a plurality of sections spaced apart at the edge where it is located.
Optionally, a number of skirt lines may be provided on the surface of said substrate facing the connecting composite; said skirt lines may be a porous structure with a higher solid volume fraction than the first porous structure or a solid structure.
It is possible to set said skirt lines at some edges of the connection area on the substrate. Each skirt line may be a continuous section or a plurality of sections arranged at intervals at the edge of the connection area where it is located.
In the case of the prosthetic implant documented in the above Embodiment, the skirt line 650 on the femoral stem 600, for example, can be located at the upper edge and at the lower edge of the connection area of the stem body 630 (upper) (
In different examples, the skirt line may be a strip structure outlining the edge where it is located, the structure itself having a certain width and raised on the substrate surface. One side of the structure touches (or further connects) the opposite edge of the composite, the opposite other side may be openly arranged (not touching or connecting with other components), or the opposite other side may touch (or further connected). Alternatively, the side of the skirt line in contact with (or further connected to) the opposite edge of the composite may be similarly implemented as a recess side surface of the substrate, and the opposite side of the skirt line may extend as a portion of the substrate next to the recess opening without protruding from the surface of the substrate. On the side of the skirt line in contact with (or further connected to) the opposite edge of the composite, a positioning structure such as a bevel and/or a snap may be provided.
The present invention is not limited to the number and location of the welding points of the substrate and the composite body; for example, the welding points may be distributed in the non-edge area of the composite body. And when the substrate is provided with a skirt line, some of the welding points can preferably be distributed and set on the skirt line of the substrate and the corresponding edge of the composite body in contact with the skirt line; there can be no other welding points, or some other welding points can be arranged in the non-edge area of the composite body. The welding at the corresponding skirt line position is relatively easy to implement and the reliability of the connection is relatively high, and the design selection process for the location of the welding points is simplified and the efficiency is improved.
Although the contents of the present invention have been described in detail by the above preferred Embodiments, it should be recognized that the above description should not be considered a limitation of the present invention. A variety of modifications and alternatives to the present invention will be apparent to those skilled in the art after reading the foregoing. Accordingly, the scope of protection of the present invention shall be limited by the appended Claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201911394644.2 | Dec 2019 | CN | national |
| 202011184579.3 | Oct 2020 | CN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CN2020/136523 | 12/15/2020 | WO |
