Patent Application
20170165077
The present invention relates to devices, systems and methods for use in fixing fasteners to bone tissue.
In orthopedic surgery it is common to secure a bone screw to a patient's bone. Bone fracture repair is surgery to fix a broken bone using plates, nails, screws, or pins. It is common in the treatment of fractures to attach a plate to the bone utilizing bone screws. The resulting construct prevents motion of the fractured bone so that the bone can heal. Alternatively, one or more screws may be inserted across the break to hold it in place.
In the treatment of spinal disorders, pedicle screws are inserted into the patient's vertebrae to serve as anchor points that can then be connected with a rod. This construct prevents motion of the vertebral segments that are to be fused.
In the treatment of detached tendons, screw-like tissue anchors are inserted into the patient's bone to serve as an anchor for the reattachment of the tendon.
One complication with the use of bone screws is the loss of fixation or grip between the bone screw and the patient's bone. Another complication with the use of bone screws is the stripping of the hole in the bone when the bone screw is inserted. This results in the loss of purchase and holding strength of the bone screw.
The presence of osteoporotic bone can increase the likelihood of complications by reducing the purchase or grip of the bone screw to the patient's bone, resulting in a loss of holding strength and loosening of the bone screw or pullout of the bone screw.
Infections deep inside bone require systemic antibacterial treatments, which disrupt entire systems.
Cellular responses and micro-organisms that create biofilms prevent bony ingrowth.
A woven patch can be used in orthopedics. Currently, commercial applications use mesh, for example, to secure the lower, tibial end of a soft tissue ACL graft. In this sleeve, as described in the GTS Sleeve document, two of the lumens hold graft tissue and the third lumen accepts the GTS tapered fixation screw. See GTS Sleeve document. Another commercial application, such as the opti-mesh 3-d deployable mesh pouch (spinology), is used in intervertebral space by containing bone material and restoring the height of vertebrae. In essence, this is a cement restrictor with a pouch filled with cement. Third, other fiber or suture-based technologies are non-mesh. Pedicle shields have also been used with a semi-circular surface that are implanted within the pedicle to protect the spinal canal.
Current solutions to secure bone screws have not adequately addressed screw failure and the underlying causes of screw failure. Current solutions have also not facilitated bone healing through woven patches.
A woven patch for interfacing with a bone surface can include: a sleeve body comprising a plurality of sets of interwoven filaments that form a two-dimensional lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the lattice at a predetermined spatial relationship, the plurality of sets of interwoven monofilaments having a plurality of different diameters, the sleeve body being configured to surround at least a portion of a fastener; a first end that is configured to interface with at least a portion of the fastener; and a second end that is opposite of the first end to the sleeve body.
In a first state, the sleeve body has a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a direction as a thickness of the sleeve body. In a second state when a fastener is inserted into or applied to the lattice, pressure from the fastener is transmitted to the lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
The interwoven filaments can extend across the lattice at an angle of about 45 degrees with respect to a length of the woven patch. The distributed protuberances can be arranged in a diamond-shaped pattern grid. A length of the sleeve body is in a range from about 10 mm to 100 mm.
A woven retention device for interfacing with a bone surface can include: a sleeve body comprising a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship, the sleeve body being configured to surround at least a portion of a fastener, each of the plurality of protuberances being formed by an intersection point of two or more of the plurality of filaments that outline a plurality of apertures, the sleeve body comprising an orthopedic biomaterial; a proximal end that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener; and a distal end that is distal to the sleeve body.
In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener can be transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
The sleeve body can be configured to expand. The woven retention device can further comprise a screw-activated device including i) a screw having a threaded portion and ii) a bolt that is configured to be threaded along the threaded portion of the screw.
A first end of the screw can be attached to the distal end of the woven retention device and at least a portion of the threaded portion runs along a longitudinal direction of the body inside the woven retention device, and a second end of the screw can be configured to accept the bolt such that when the bolt is moved inside the tubular structure, a compressive force is exerted on the woven retention device by the bolt in a direction parallel to a longitudinal axis of the tubular structure.
The compressive force radially can expand the tubular structure to the expanded state. When the fastener is inserted a predetermined distance into the tubular structure, the proximal end of the woven retention device can be configured to detach from the fastener.
The sleeve body can be configured to impede biofilm formation. The biomaterial can be made of a material that impedes biofilm formation. The sleeve body can have a structure that impedes biofilm formation. The sleeve body can be configured to receive a portion of the soft tissue and the sleeve body is configured to impede biofilm formation surrounding the soft tissue. The sleeve body can comprise a coating on the plurality of filaments, wherein the coating comprises an orthopedic biomaterial. The plurality of filaments can comprise the orthopedic biomaterial. The orthopedic biomaterial can include one of PLA, PGA, PLLA, PET, PEEK, PEKK, polypropylene, polyamides, PTFE, calcium phosphate, platinum, cobalt chrome, nitinol, stainless steel, titanium, PEEK, silk and collagen, bioceramics, aluminum oxide, calcium phosphate, hydroxyapatite, glass ceramics, or any combination thereof.
A lattice for interfacing with a bone surface can comprise: a sleeve body comprising a plurality of filaments that form a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship, the plurality of filaments having a plurality of different filament diameters; a proximal end that is proximal to the sleeve body and that is configured to receive at least one of a fastener and at least a portion of a soft tissue; and a distal end that is distal to the sleeve body.
The sleeve body can have a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments, the plurality of combinations of filament cross-section geometries forming a plurality of different protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In an implanted state of the woven retention device, the tubular lattice can be configured to interface with both the soft tissue and the bone surface to secure the soft tissue to the bone surface, the spatial relationship of the protuberances changing according to a function of bone density.
The sleeve body can be configured to receive a portion of the soft tissue. The lattice can further include an anchoring device that is configured to apply pressure to one or more regions of the soft tissue, the sleeve body distributing the applied pressure through the soft tissue and the bone surface.
The anchoring device can penetrate the soft tissue and protrude into the bone surface. The filaments can be interwoven filaments and the interwoven filaments comprise at least one set of filament that is a felted filament. The sleeve body can comprise felted filaments.
The sleeve body can be configured to receive a tendon. The sleeve body can comprise an orthopedic biomaterial, the sleeve body being configured to minimize biofilm formation on the bone and/or soft tissue.
A non-transitory computer-readable storage medium having data thereon representing a three-dimensional model suitable for use in manufacturing a three-dimensional retention device for interfacing with a bone surface can, when executed by at least one processor, cause a computing system use the data in forming the three-dimensional retention device to create a plurality of filaments having input regions that interlace with other filaments. The retention device can include: a sleeve body comprising a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship, the sleeve body being configured to surround at least a portion of a fastener, each of the plurality of protuberances being formed by an intersection point of two or more of the plurality of filaments, the sleeve body including an orthopedic biomaterial; a proximal end that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener; and a distal end that is distal to the sleeve body.
In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body, and in a second state when a fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
Additional features, advantages, and embodiments of the invention are set forth or apparent from consideration of the following detailed description, drawings and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.
Additional features, advantages, and embodiments of the invention are set forth or apparent from consideration of the following detailed description, drawings and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.
Some embodiments of the current invention are discussed in detail below. In describing embodiments, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected. A person skilled in the relevant art will recognize that other equivalent components can be employed and other methods developed without departing from the broad concepts of the current invention. All references cited anywhere in this specification, including the Background and Detailed Description sections, are incorporated by reference as if each had been individually incorporated.
The devices, systems and methods described herein may be used in the area of orthopedics and, in particular, orthopedic repairs. These include various devices, systems and methods directed to fixing and/or retaining fasteners in orthopedic applications. Fixing or retaining fasteners to bone tissue is complicated by the underlining bone tissue. Understanding that an underlying cause of failure with internal fixation in bone tissue is the bone, the devices, systems and methods described herein provide for solutions that address the implant site. At the implant site, the hole and the bone benefit from an enhanced interface.
The fixation and/or retention devices, systems and methods described herein maximize fixation and/or retention in the bone tissue, including, osteoporotic bone, bone of a poor quality, and mechanically poor bone in addition to healthy bone tissue. The fixation and/or retention devices, systems and methods described herein may be used with any type of fixation including, any types of screws.
The devices, systems and methods described herein enhance the interaction of a fastener, such as a bone anchor, to a bone hole to provide enhanced fixation. Additionally, the devices, systems and methods may repair the surface of the bone hole following damage to the bone hole as in the case of stripping of the hole in the bone when a bone screw is over-tightened. Also, the devices, systems and methods provide for an enhanced bone hole surface for the reattachment of tendons in, for example, anterior/posterior cruciate ligament repair procedures, rotator cuff repair procedures, etc. The devices enhance the surface of a bone hole to enhance fixation of a bone anchor to bone and permits bone ingrowth into its structure. The devices enhance the interaction between the surface of a bone hole and the fixation device. The devices interdigitate with the bony structure and interact with the fixation device. The device alone, as a single device, enhances the surface of a bone hole to enhance fixation of a bone anchor to bone and accommodates variations in the diameter and depth of the bone hole. The devices, systems and methods can enhance fixation without requiring the use of cement and/or adhesives.
The retention devices, lattices, fixation sleeves and/or patches, systems and methods described herein maximize fixation and/or retention in the bone tissue, including, osteoporotic bone, bone of a poor quality, and mechanically poor bone in addition to healthy bone tissue. The fixation sleeve and/or patches, systems and methods described herein may be used with any type of fixation including, any types of screws.
The devices, systems and methods described herein can support a bone structure. In one embodiment, the devices, systems and methods can enhance the interaction of a bone anchor, such as a screw, a nail or a bone dowel, to a bone hole to provide enhanced fixation. Additionally, the devices, systems and methods may repair the exterior or interior surface of the bone following damage to the bone as in the case of stripping of the bone when a bone screw is over-tightened. Also, the devices, systems and methods provide for an enhanced bone surface for the reattachment of tendons in, for example, anterior/posterior cruciate ligament repair procedures, rotator cuff repair procedures, etc. The devices can enhance the surface of a bone to enhance fixation of a bone anchor to bone and can permit bone ingrowth into its structure. The devices can enhance the interaction between the surface of the bone and the fixation device. The devices can interdigitate with the bony structure and interact with the fixation device. The device alone, as a single device, enhances the surface of a bone hole to enhance fixation of a bone anchor to bone and accommodates variations in the diameter and depth of the bone hole. In one embodiment, the devices, systems and methods can enhance fixation without requiring the use of cement and/or adhesives. In another embodiment, bone cement can be applied to the surface of the bone and the patch to provide a passive patch.
Reference to a woven retention device is meant to include an implantable woven patch or implantable retention device such as a sleeve. Various embodiments described are meant to be interchangeably used with each other.
Referring now to the figures,
The lattice may include a plurality of protuberances distributed on an interior surface 110 and an exterior surface 108 of the lattice at a predetermined spatial relationship. Each of the plurality of protuberances may be formed by an intersection of filaments. More particularly, each of the plurality of protuberances may be formed by an intersection point of two or more of the plurality of interwoven filaments. The intersection can be referred to as a location and/or point. Additionally, the interwoven filaments may outline apertures that allow for bone ingrowth. The woven retention device can also have a proximal end 114 that is proximal to the sleeve body 106 and that is configured to receive at least a portion of a fastener 102 such that the sleeve body 106 may surround at least a portion of the fastener 102 when inserted therein. The woven retention device 100 can also have a distal end 116 that is distal to the sleeve body 106. In some embodiments, the distal end 116 is formed to ease insertion of the woven retention device 100 into the bone hole 101. For example, the distal end 116 in
Embodiments of the woven retention device include a woven retention device to impede biofilm formation. The woven retention system 100 can include a sleeve body 106 comprising a plurality of interwoven filaments that form a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The woven retention system 100 can include a proximal end that is proximal to the sleeve body and that is configured to receive a fastener; and a distal end that is distal to the sleeve body on an opposing side as the proximal end.
As can be seen in
The area of the apertures can change dynamically by the interwoven filaments translating with respect to each other without substantial stretching of the interwoven filaments. When the woven retention device is in a constricted, the aperture areas can change by a function of a braid of the filaments.
The area of the aperture can be in a number of various shapes. For example, as shown in
By having differently shaped and sized apertures, a more conducive environment for non-uniform bony surface can allow for ingrowth of bone to occur. Additionally, improved interdigitation with the bony structure can be achieved with a combination of the apertures and protuberances.
The spatial relationship of the protuberances of the woven retention device can affect the formation of biofilms on the fastener and/or woven retention device. For example, micro-organisms may attach to the fastener and/or the woven retention device. After attachment, the micro-organisms can mature and clog the apertures of the woven retention device. For example, the apertures of the woven retention device allow for porosity that enable bone ingrowth to occur, which facilitates healing. In embodiments of this invention, porosity and pore sizes of the woven retention device are associated with these and other biological responses. For example, very small pore sizes or apertures make the formation of biofilms easier. One of the first stages of development can include 1) initial attachment of the microorganisms, and 2) irreversible attachment (which can lead to buildup). Embodiments of the invention here relate to both phases of preventing initial attachment by the filaments being thin enough and of a material to resist attachment and also having the pore sizes be large enough to prevent irreversible attachment. Thus, larger pore sizes can prevent biofilm attachment. Further, pore sizes can be affected by the degree of the weave intersections. At a 45 degree braid angle, a maximum pore size relationship can be achieved. Thus, even if a biofilm attaches to the filaments, by having large pore sizes, spreading or maturing of the biofilm can be prevented or slowed. Also, other biological responses besides biofilm formation, such as fibrosis, relate to the porosity of the woven retention device.
Further there may be some materials that prevent the cellular response of biofilms from building up and maturing. In some embodiments, the woven retention device 100 can include an orthopedic biomaterial that impedes or prevents biofilm attachment or maturation and/or that stimulates bone growth. Biomaterials in orthopedics can be made of biocompatible, biofunctional, non-toxic, machinable, moldable, extrudable, having tensile strength, yield strength, elastic modulus, corrosion and fatigue resistance, surface finish, creep, hardness. See Patel and Gohil, “A Review on Biomaterials: Scope, Applications & Human Anatomy Significance,” International Journal of Emerging Technology and Advanced Engineering 2(4): pp. 91-93 (April 2012) (Patel), the content of which is hereby incorporated herein by reference in its entirety. For example, the interwoven filaments can include biomaterials and the biomaterials can be manufactured in fiber format. The woven or non-woven structures described above can be made of non-resorbable or bioabsorbable polymers, metals, biological products or ceramics. Bio resorbable polymer material can be used. For example, the sleeve material can be bioabsorbable and dissolve for complete healing, reduced risk of particulate debris, and have no removal complications as a result. The bioabsorbable polymer can include at least one of thermoplastic aliphatic polyester (PLA), polyglycolide (PGA), polylactide (PLLA) and resorbable polyamides. Alternatively, the sleeve material does not degrade but stays as a structural support of the bone. A non-resorbable polymer material can be biologically suited for use in bone, such as PET (polyehthylene terephthalate), ultra high molecular weight polyethylene, polyether etherketone (PEEK), polyether ketoneketone (PEKK), polypropylene, polyamides, PTFE, calcium phosphate and variations of sutures.
A hydrophilic biomaterial such as a metal can be hydrophilic and attract bone. In one embodiment, metals can also be used such as titanium, tantalum, nickel titanium (nitinol), platinum, cobalt chrome/cobalt chromium, or a blend of all the listed metals. For example, the metals can include at least one of nickel-titanium (Ni—Ti) or nitinol, stainless steel, platinum, titanium, cobalt chrome, cobalt chromium, or any combination thereof. In an embodiment, the metal material can be roughened to create a roughness characteristic that attracts bone, or encourage bone to grow to it or group to it. In an embodiment, the biomaterial such as a metal can have a radioactive property such that the biomaterial can be detected using electromagnetic radiation, such as X-rays. In one embodiment, the woven retention device can be made of fibers of a bone-promoting biomaterial in combination with fibers of a material that does not promote bone growth. For example, the woven retention device can be made of fibers of titanium, which promotes bone growth, as well as PEEK, which promotes bone growth less. Additionally, fibers of PEKK, which can promote bone growth, can be used in combination with titanium and PEEK. In one embodiment, the filaments can include porous fibers.
In an embodiment, the woven retention device can be constructed with an interior surface having a tap of the metallic biomaterial that follows the path of a fastener such as a screw. In such a configuration, the woven retention device is self-tapped to receive an insert, and as the screw follows the path, the woven retention device is configured to expand. In one embodiment, the self-tapping can be produced through the weaving pattern of the fibers or through a mechanical inscribing process that machines thread that matches to the material into which the woven retention device is being inserted. For example, one metal fiber can be included among all other plastic fibers and based on the pitch of the screw, the metal fiber can be designed to follow the tap of the screw.
Biological materials or biologics, such as silk, collagen, and cat gut suture can be used. See Park and Lakes, “Biomaterials: An Introduction,” 1992, Chapter 4 (Park), the content of which is hereby incorporated by reference herein in its entirety. The biological products can include at least one of silk and collagen. Thus, the sleeve can be made of sheet fabric materials such as Silk or Felt that is not woven, but could be created by using collagen. An interior surface could be configured to interface with different structures besides a screw (clamp, smooth, roughened) to provide a strong connection as long as there are many points of contact to provide sufficient sheer strength and a monolithic structure (that is, if one point fails, whole structure does not fail).
In some embodiments, ceramic materials can be used (or bioceramics), which are inert, strong in compression, and biocompatible, such as aluminum oxide, calcium phosphate (hydroxyapatite). See Patel, page 96. For example, the sleeve material can be made of bioactive glass ceramics. See Park chapter 3. The sleeve materials can have bone regenerative qualities (bony apposition).
In some embodiments, the woven retention device 100 can include sleeve materials applied to the woven retention device 100. For example, structural integrity of the woven retention device can be a non-resorbable material, for example PET or PEEK fiber. And the woven retention device is then interlaced with a biologic fiber, such as collagen, to attract or stimulate the bone. Thus, in an embodiment, biological fibers need not provide structural or fixation support, but instead locally stimulate bone formation. Alternatively, the woven retention device can include can include all synthetic materials as non-resorbable materials and instead of interlacing biological fibers, the woven retention device can be coated with an osteostimulative agent.
Instead of a flat fiber, a rougher or more pillowy surface is also possible. In an embodiment with a monofilament/multifilament, a textured fiber instead of a flat multifilament could absorb or wick up more biological agent. In one embodiment, the woven retention device can be biofriendly and have a wicking characteristic to absorb plasma-rich platelets. The sleeve materials can have antibiotic or anti-microbial properties to reduce infections and enhance effectiveness. The woven retention device can be made of a metal that slowly releases ions over time that has anti-microbial properties. Some materials alone have antimicrobial properties. Naturally occurring Silver, for example, can be used as an anti-microbial agent. Thus, impregnating PEEK with Silver can provide an anti-microbial property. Other materials, including metals and polymers, can have anti-microbial properties in combination with other materials. The sleeve material can have drug eluting properties to stimulate bone growth and improve recovery time. And it can be provided at the local level instead of at the systemic level. The sleeve material can also be bioconductive meaning that an allograph fixation sleeve can be made using allographic tissue to create a bone based fixation sleeve in combination with long fiber bone tissue processed by Osteotech, now owned by Medtronic. The allographic tissue can be made out of different material (human based material).
The woven retention device 100 can be inserted into a hole in a bone and interact with both the bone and a screw. While the woven retention device 100 can achieve an interference fit functionality by providing additional interference in between the fastener and the bone, in some embodiments, the woven retention device can instead of and/or in addition to function as a woven retention device in accordance with the configurations, functions and advantages that are discussed herein. For example, the woven retention device can have a dual interface between a radial screw surface on one side and multiple points of contact on a bone surface on the other side. The dual interfaces on the retention device are configured to be adapted to the bony structure on the outside and the screw on the inside, as described herein in accordance with the principles of the invention. The woven retention device can be particularly beneficial for osteoporotic or weakened bone that has more space gaps than normal bone to allow additional points of contact for the interface to contact.
Thus, a woven retention device 100 for interfacing with a bone surface can include a sleeve body 106 comprising a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body 106 can be configured to surround at least a portion of a fastener 102. Each of the plurality of protuberances can be formed by an intersection point of two or more of the plurality of filaments that outline a plurality of apertures. The sleeve body 106 can include an orthopedic biomaterial
The woven retention device 100 can include a proximal end 114 that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener 102. The woven retention device 100 can include a distal end 116 that is distal to the sleeve body. In a first state, the sleeve body 106 has a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener 102 can be transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
The woven retention device 100 can thus be configured to impede biofilm formation. The biomaterial of the woven retention device 100 can be made of a material that impedes biofilm formation. The sleeve body can have a structure that impedes biofilm formation.
The sleeve body can be configured to receive a portion of the soft tissue and the sleeve body is configured to impede biofilm formation surrounding the soft tissue. The sleeve body comprises a coating on the plurality of filaments, wherein the coating comprises an orthopedic biomaterial. The plurality of filaments can comprise the orthopedic biomaterial.
The woven retention device can include an orthopedic biomaterial of one of the following: PLA, PGA, PLLA, PET, PEEK, PEKK, polypropylene, polyamides, PTFE, calcium phosphate, platinum, cobalt chrome, nitinol, stainless steel, titanium, PEEK, silk and collagen, bioceramics, aluminum oxide, calcium phosphate, hydroxyapatite, glass ceramics, or any combination thereof.
Referring now to the figures,
The lattice may include a plurality of protuberances distributed on a first surface, or an interior surface 210, and a second surface, or an exterior surface 208, of the lattice at a predetermined spatial relationship. Each of the plurality of protuberances may be formed by an intersection of filaments. More particularly, each of the plurality of protuberances may be formed by an intersection point of two or more of the plurality of interwoven filaments. The intersection can be referred to as a location and/or point. Additionally, the interwoven filaments may outline interstices that allow for bone ingrowth. The woven patch can also have a proximal end 214 that is proximal to the sleeve body 206 and that is configured to be applied to at least a portion of a fastener 202. The woven patch 200 can also have a distal end 216 that is distal to the sleeve body 206. In some embodiments, the distal end 216 is formed to ease insertion of the woven patch 200. For example, the distal end 216 in
The woven patch 200 can be applied to a bone and interact with both the bone and a screw. While the woven patch 200 can achieve an interference fit functionality by providing additional interference in between a fastener and the bone, in some embodiments, the woven patch can instead of and/or in addition to function as a woven patch in accordance with the configurations, functions and advantages that are discussed herein. For example, the woven patch can have a dual interface between a radial screw surface on one side and multiple points of contact on a bone surface on the other side. The dual interfaces on the patch are configured to be adapted to the bony structure on the outside and the screw on the inside, as described herein in accordance with the principles of the invention. The woven patch can be particularly beneficial for osteoporotic or weakened bone that has more space gaps than normal bone to allow additional points of contact for the interface to contact.
The plurality of interwoven filaments, according to an embodiment of the woven retention device 100, are visible in
Embodiments of the invention are not limited to being used with a screw-type fastener. In some embodiments, the fastener may be a nail, rod, prosthetic, or other device for implanting at least partially in a bone. Additionally, in some embodiments a biological material or structure, such as a ligament, may be inserted into the woven retention device.
The spatial relationship of the plurality of protuberances can also change as a function of loading and/or the fastener. The spatial relationship of the plurality of protuberances can change as a function of an interfacing surface shape of the fastener 102. As shown in
The spatial relationship of the plurality of protuberances can also change as a function of an interfacing surface shape based on the length of the surface. For example, the surface of the fastener 102 can also be various lengths. As seen from
In some embodiments, the woven retention device 100 may be specifically configured for a bone of a particular density or range of densities. For example, the structural configuration, material properties, or other aspects of the woven retention device may be adjusted to provide desired engagement with the bone surface of a particular density or range of densities. However, in some embodiments, a particular woven retention device may be suitable for use in bones of varying densities.
Before application or insertion onto or into a bone surface, the woven patch 200 may be in a first, relaxed state at the position. During or after insertion into or after application onto the bone 203, however, the woven patch 200 may also assume a contracted or expanded state. The plurality of interwoven filaments, according to an embodiment of the woven patch 200, are visible in
Embodiments of the invention are not limited to being used with a screw-type fastener. In some embodiments, the fastener may be a nail, dowel, rod, prosthetic, or other device for implanting at least partially in a bone. Additionally, in some embodiments a biological material or structure, such as a ligament, may be inserted into the woven patch.
The spatial relationship of the plurality of protuberances can also change as a function of loading and/or the fastener. The spatial relationship of the plurality of protuberances can change as a function of an interfacing surface shape of the fastener 202. As shown in
The spatial relationship of the plurality of protuberances can also change as a function of an interfacing surface shape based on the length of the surface. For example, the surface of the fastener 202 can also be various lengths. One factor that affects the small screw having a greater pullout resistance in percent change is that more interaction with the woven patch 200 can be possible with a smaller fastener as a percentage of the fastener's percentage of coverage. This can result in a larger differential in pull out resistance in the smaller sizes than there is in the larger sizes because of the increased interaction. In one embodiment, the mechanical properties of the woven patch can compensate for differences in the fastener surface. For example, to increase bone surface interaction with a fastener 202 that has a coarse thread, a woven patch with a greater level of stability can be used to prevent the filaments from retreating too far into the valleys 236 and instead interacting with the bone surface.
In some embodiments, the woven patch 200 may be specifically configured for a bone of a particular density or range of densities. For example, the structural configuration, material properties, or other aspects of the woven patch may be adjusted to provide desired engagement with the bone surface of a particular density or range of densities. However, in some embodiments, a particular woven patch may be suitable for use in bones of varying densities.
The change in the spatial relationship of the protuberances between
The change in the spatial relationship of the protuberances between
In one embodiment, the sets of filaments have a degree of stability and rigidity to form a tubular lattice in the relaxed state. The flexibility and stability of the tubular lattice may be such that the woven retention device 100 is able to return to an initial state from a deformed state. The deformed state may be the result of the woven retention device being in compression or tension either radially or longitudinally, and the deformation may be elastic deformation.
Further, a second thickness 304 represents the thickness of an intersection of two filaments 310, 314, the filament 310 having a relatively small thickness and the filament 314 having a relatively large thickness. In some embodiments, this intersection may be formed by a multifilament (310) overlapping a monofilament (314). In another embodiment, filament 310 can be a monofilament having a smaller diameter than monofilament 314. Thus, in another embodiment, intersection 304 can be formed by a monofilament 310 overlapping a monofilament 314.
A third thickness 306 represents the thickness of an intersection of two filaments 312, 316. In an embodiment, this intersection may be formed by a multifilament (312) over a monofilament (316). In another embodiment, filament 312 can be a monofilament having a thinner diameter than monofilament 316. Thus, in another embodiment, the third thickness 306 can be formed by an intersection of monofilament 312 overlapping monofilament 316. The thicknesses 304 and 306 may have a same thickness if the filaments 310 and 312 have a same thickness, and the filaments 314 and 316 have a same thickness. Alternatively, the thicknesses of filaments 310 and 312 may be different, and the thickness of filaments 310 and 312 may be different, while the thicknesses 304 and 306 may be the same or different.
Next, a fourth thickness 308 represents the thickness between two relatively thick filaments 314, 316. In an embodiment, this intersection may be formed by a monofilament 314 overlapping a monofilament 316. Thus, each of the protuberance geometries and/or thicknesses 302, 304, 306, 308 allow for interfacing with the fastener on one side and the bone on the other side, and distributing pressure outwardly from the fastener to the bone in a distributed manner. In one embodiment, monofilament 314 can have a same diameter as monofilament 316. However, in another embodiment, the monofilaments 314, 316 can have different thicknesses.
As described above, protuberances on the interior surface of the woven retention device interface with the fastener and the protuberances of the exterior surface of the woven retention device interface with the bone surface. According to the varying protuberance thicknesses described above, the tubular lattice of the woven retention device 100 may have an outer radius spanning from a furthest outwardly extending protuberance in the radial direction on the exterior surface of the tubular lattice to a center point and/or central axis of the tubular lattice, the tubular lattice having an inner radius spanning from a furthest inwardly protruding protuberance in the radial direction on the interior surface of the tubular lattice to the center point of the tubular lattice. The tubular lattice may have an average radius that is an average between the outer radius and the inner radius. In one embodiment, the outer radius of the woven retention device 100 is greatest at the cross-section geometries that have the greatest protuberance thicknesses. Further, the inner radius of the woven retention device 100 may be the smallest at the cross-section geometries that have the largest protuberance thicknesses.
In one embodiment in a relaxed state, distributed protuberances on the exterior surface can have more than two different heights in relation to the distance from a center point of the cross-section of the tubular lattice to peaks of the distributed protuberances on the exterior surface. Further, the distributed protuberances on the exterior surface can have more than two different angles of protrusions, or amplitudes, where the amplitude of a monofilament overlying a monofilament has a higher amplitude than where the monofilament overlies a multifilament. Further, the angle, protrusion, and/or curvature of the multifilament overlying a monofilament is greater than that of a multifilament overlying a multifilament because the variance or the steepness of the curve of the multi-filament is greater. The filaments, density, and/or pick count, for example, can contribute to the difference in the sharpness, angle and/or amplitude of the protrusions. The more pronounced the protrusion, the sharper the protrusion can be considered. Various relationships between the diameter of the retention device, the thickness of the first filament(s) and, the thickness of the overlying filament(s), and the weave pattern contribute to the resulting protuberances and protuberance geometries. Varying the protuberances and protuberance geometries can provide for woven retention devices having predetermined protuberances that accommodate various bony structures. The different heights and angles of distributed protuberances on the exterior surface can allow for interdigitation with bone surfaces, especially if the bone surface is irregularly shaped.
In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener can be transmitted to the tubular lattice such that at least one of (i) the heights of the protuberances on the exterior surface, (ii) the amplitudes of the protuberances on the exterior surface, and (iii) the ratio of the height to the average radius, can change to accommodate deviations in the bone surface.
In one embodiment, the sets of filaments have a degree of stability and rigidity to form a lattice in the relaxed state. The flexibility and stability of the lattice may be such that the woven patch 200 is able to return to an initial state from a deformed state. The deformed state may be the result of the woven patch being in compression or tension either radially or longitudinally, and the deformation may be elastic deformation.
Further, a second thickness 404 represents the thickness of an intersection of two filaments 410, 414, the filament 410 having a relatively small thickness and the filament 414 having a relatively large thickness. In some embodiments, this intersection may be formed by a multifilament (410) overlapping a monofilament (414). In another embodiment, filament 410 can be a monofilament having a smaller diameter than monofilament 414. Thus, in another embodiment, intersection 404 can be formed by a monofilament 410 overlapping a monofilament 414.
A third thickness 406 represents the thickness of an intersection of two filaments 412, 416. In an embodiment, this intersection may be formed by a multifilament (412) over a monofilament (416). In another embodiment, filament 412 can be a monofilament having a thinner diameter than monofilament 416. Thus, in another embodiment, the third thickness 306 can be formed by an intersection of monofilament 412 overlapping monofilament 416. The thicknesses 404 and 406 may have a same thickness if the filaments 410 and 412 have a same thickness, and the filaments 414 and 416 have a same thickness. Alternatively, the thicknesses of filaments 410 and 412 may be different, and the thickness of filaments 410 and 412 may be different, while the thicknesses 404 and 406 may be the same or different.
Next, a fourth thickness 408 represents the thickness between two relatively thick filaments 414, 416. In an embodiment, this intersection may be formed by a monofilament 414 overlapping a monofilament 416. Thus, each of the protuberance geometries and/or thicknesses 402, 404, 406, 408 allow for interfacing with the fastener on one side and the bone on the other side, and distributing pressure outwardly from the fastener to the bone in a distributed manner. In one embodiment, monofilament 414 can have a same diameter as monofilament 416. However, in another embodiment, the monofilaments 414, 416 can have different thicknesses.
According to an embodiment, the woven retention device 100 can include up to ten sets of filaments in each of the first and second plurality 123, 125 of sets of filaments. In another embodiment, for each of the first and second plurality 123, 125 of sets of filaments, the woven retention device 100 can include at least two sets of filaments. Thus, each of the sets of filaments may have a degree of flexibility that allows for expandability of the woven retention device 100. The filament properties and characteristics can be varied, and the number of filaments used in the weave contributes to the stability and/or rigidity of the woven retention device. For example, a small-sized woven retention device may include a half set of filaments such as 12 filament in one direction and 12 in the other direction. Whereas, a larger size may weave 24 filaments and 24 filaments. Depending upon the size of the woven retention device, a range of the quantity of filaments can vary from 2/2 to 36/36. For example, the quantity of filaments can be 8/8, 10/10, 12/12, 24/24 and/or 36/36, according to some embodiments. Additionally, other filament quantities are also possible. An even number of filaments and bobbins are contemplated, resulting in a symmetrical pattern. But an odd number of filaments can be utilized as well and would result in a non-symmetrical pattern.
As shown in
As shown in
As shown in
In alternate embodiments, the first inner filament 126 can be a round monofilament 142, the first outer filament 128 can be a round monofilament 140 having the same or different diameter as monofilament 142, the second inner filament 132 can be a round monofilament 142 and the second outer filament 130 can be a round monofilament 140 having a same or different diameter as round monofilament 142.
Each of the different monofilament/multifilament arrangements allow for the protuberances to occur at different regions. In
As can be seen from
As shown in
In alternate embodiments, the first inner filament 226 can be a round monofilament 242, the first outer filament 228 can be a round monofilament 240 having the same or different diameter as monofilament 242, the second inner filament 232 can be a round monofilament 242 and the second outer filament 230 can be a round monofilament 240 having a same or different diameter as round monofilament 242.
Each of the different monofilament/multifilament arrangements allow for the protuberances to occur at different regions. In
As can be seen from
For
The round monofilaments of the woven retention device can have differing diameters. In one embodiment, the round monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. In one embodiment, the round monofilament of the woven retention device is 0.2 mm.
The multifilaments of the woven retention device according to some embodiments can have various thicknesses and widths. For example, a multifilament may have a thickness of less than 0.1 mm. The cross-sectional shape, e.g., flat or round, and the texture, for example, of the multifilaments can also be relevant. The number of filaments and pattern can also be relevant. As such, with those considerations, various filament linear mass densities can be contemplated. For example, the multifilaments can have a linear mass density in a range of about 150-250 denier. In one embodiment, the multifilaments can have a linear mass density of about 200 denier.
The woven retention device can be configured such that the intersecting sets of filaments form a plurality of differently shaped and differently sized apertures. In one embodiment, as shown in
The round monofilaments of the woven patch can have differing diameters. In one embodiment, the round monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. In one embodiment, the round monofilament of the woven patch is 0.2 mm.
The multifilaments of the woven patch according to some embodiments can have various thicknesses and widths. For example, a multifilament may have a thickness of less than 0.1 mm. The cross-sectional shape, e.g., flat or round, and the texture, for example, of the multifilaments can also be relevant. The number of filaments and pattern can also be relevant. As such, with those considerations, various filament linear mass densities can be contemplated. For example, the multifilaments can have a linear mass density in a range of about 150-250 denier. In one embodiment, the multifilaments can have a linear mass density of about 200 denier.
In an embodiment where the woven patch 200 is applied to a bone dowel, an allograph material may reincorporate over time the size of the openings. The woven patch 200 may be provided around a bony structure or structures to contain the pieces and allow for regeneration. Thus, the woven patch may provide an interface for allowing bony tissue to grow through it, and can enhance fixation of the encapsulated material to prevent the pieces from moving around. The woven patch thus can allow in one embodiment a natural healing process for bone tissue. The woven patch can be made of fiberglass or carbon fiber and can serve as an epoxy for reinforcement strength. For example, the woven patch can provide an interface so that the epoxy has a chance to not migrate while the bone tissue undergoes healing. In one embodiment, the woven patch can enable putting in a bone dowel in and ensuring that it is not going to migrate because of an improved interface that does not arrest the healing process or arrest the bone formation process. As an example, a bone void filler can ensure that the final construct needs to stay without slowing down or altering the normal metabolic healing process. The bone void filler in this example is not meant as an element to structural integrity to give the resulting construct more rigidity—instead the bone void filler can act like a carbon fiber piece of epoxy.
The woven patch 200 can be configured such that the intersecting sets of filaments form a plurality of differently shaped and differently sized interstices. In one embodiment, as shown in
The tapering end portion can be seen from
In
In
A woven patch 200 for interfacing with a bone surface can thus include a sleeve body comprising a plurality of sets of interwoven filaments that form a two-dimensional lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the lattice at a predetermined spatial relationship. The plurality of sets of interwoven monofilaments can have a plurality of different diameters, and the sleeve body can be configured to surround at least a portion of a fastener.
The woven patch 200 can have a first end that is configured to interface with at least a portion of the fastener and a second end that is opposite of the first end to the sleeve body.
In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses. A thickness of each protuberance can be measured in a direction as a thickness of the sleeve body. In a second state when a fastener is inserted into or applied to the lattice, pressure from the fastener can be transmitted to the lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
The interwoven filaments can extend across the lattice at an angle of about 45 degrees with respect to a length of the woven patch. The distributed protuberances are arranged in a diamond-shaped pattern grid. A length of the sleeve body is in a range from about 10 mm to 100 mm.
As can be seen from
As can be seen from
In a relaxed state, the woven retention device can be of various lengths and diameters.
In a relaxed state, the woven patch can be of various lengths and diameters. In one embodiment, the woven patch can have a length in a range of about 10 mm to 100 mm. In an embodiment, the woven patch can have a length in a range of about 30 mm to 40 mm. The length of the woven patch can come in dynamically cuttable; and/or predetermined length, such as small—30 mm; medium—40 mm, large—40 mm, and other sizes (or ranges) are also possible.
Next, the woven patch can be used as a patch for a pedicle breach or in supporting a pedicle breach, which is insulation for potential nerve breach in cases of non-benign apertures in the pedicle. This can serve as filling in the gaps between bone and a fastener to avoid nerve damage or discomfort. In one embodiment, the woven patch can encapsulate the vertebrae bone, including one or more pedicle portions. The patch can be used for bone sub-support in structural scaffolding of bone that is in need of strengthening. A woven patch can support bone in a certain shape or manner. A biotextile patch can be used to surround a bone to give it support instead of a classical stainless steel cable.
Embodiments of the invention are not limited to being used in any particular bone, and may be configured for use in any bone.
As shown in
In one embodiment, the sleeve can radially expand and contract from a first state to a second state. The first state has a constricted diameter and the second state is a uniformly expanded middle portion. A smooth surface for the inner layer interface has application in soft tissue. Biotextile technology can be used for soft tissue reapproximation or repair of any muscoskeletal injury. A biofabric can be used for other means of fixation. The smooth surface may be used in a Chinese finger trap functionality.
The sleeve can work at filling the hole better to provide more points of contact for the bone interface. One way it can do so is by having two sleeves nested, which can add additional advantages using the multiple points of contact interface. It can also have a homogeneous and uniform interface for screw engagement so that a number of characteristics of the sleeve can be achieved: Rigidity, Compressibility, Stability, Sheer strength (at a predetermined level), Tensile strength (at a predetermined level). The implantable retention device can be made of at least one of silk, non-woven felt, and collagen.
The implantable retention device can be made such that the body further includes a plurality of engagement sites on the exterior and interior surfaces of the body that interact with a surface of the bone tissue and a surface of the fastener, respectively. In one embodiment, the plurality of engagement sites can exert a plurality of retaining forces on the surface of the bone and the surface of the fastener to resist removal of the fastener from the implantable retention device and to resist removal of the implantable retention device from the bone. In one embodiment, the implantable retention device can be configured such that when an engagement site fails to exert a sufficient retaining force, others of the plurality of points of contact compensate for the failed engagement site. In one embodiment, the engagement sites comprise elements that are raised relative to the exterior and interior surfaces of the body.
The inner surface could be configured to interface with different structures besides a screw (clamp, smooth, roughened) to provide a strong connection as long as there are many points of contact to provide sufficient sheer strength and a monolithic structure (that is, if one point fails, whole structure does not fail). Thus, in one embodiment, the implantable retention device can be monolithic.
In one embodiment, the implantable retention device 500 has a shear strength along an axis substantially orthogonal to a longitudinal axis of the hollow tube structure such that the hollow tube structure resists shearing from surface areas of the bone tissue and the fastener up to a predetermined threshold when the fastener is inserted into the bone hole.
Further, the degree of flexibility of the implantable retention device can allow for the hollow tube structure to change to a contorted state when the fastener is inserted. In one embodiment, the contorted state can be different than the resting state, the constricted state and the expanded state. In an embodiment of the contorted state of the implantable retention device, at least portions of the body interdigitate with variations in a surface of the fastener 502.
In one embodiment, a tensile force applied to the hollow tube structure parallel to a longitudinal axis of the hollow tube structure causes the hollow tube structure to radially constrict and the compressive force applied to the hollow tube structure parallel to the longitudinal axis of the hollow tube structure causes the hollow tube structure to expand.
In one embodiment, as shown in
A first end of the screw can be attached to the distal end 516 of the woven retention device and at least a portion of the threaded portion 513 can run along a longitudinal direction of the body inside the woven retention device 500. A second end 515 of the screw 502 is configured to accept the bolt 511 such that when the bolt is moved inside the tubular structure, a compressive force is exerted on the woven retention device by the bolt in a direction parallel to a longitudinal axis of the tubular structure.
The compressive force radially can expand the tubular structure to the expanded state. When the fastener 502 is inserted a predetermined distance into the tubular structure, the proximal end 514 of the woven retention device can be configured to detach from the fastener 502.
The screw-activated device can include a screw 502 and a bolt 511 that is configured to be threaded along threads 513 of the screw 502. The implantable retention device can further include the screw-activated device, where a distal end portion 516 of the screw-activated device is attached to the distal end of the implantable retention device. In one embodiment, when the bolt 511 is moved along the screw 502 inside the hollow tube structure, a compressive force is exerted on the implantable retention device by the screw-activated device in a direction parallel to a longitudinal axis of the hollow tube structure, the compressive force radially expanding the hollow tube structure to the expanded state. In one embodiment, a washer 520 can be used to interface with the implantable retention device and the screw. For example, the washer 520 may be attached to the proximal end of the implantable retention device such that when the screw 502 is moved along the threaded portion 513, the implantable retention device can uniformly expand from uniform pressure from the washer 520.
In one embodiment, the implantable retention device can include a screw-activated device including i) a screw 502 having a threaded portion 513 and ii) a bolt 511 that is configured to be threaded along the threaded portion 513 of the screw 502. In one embodiment, a first end 516 of the screw can be attached to the distal end portion 516 at the distal end of the implantable retention device 500 and at least a portion of the threaded portion 513 runs along a longitudinal direction of the body inside the implantable retention device 500. A second end 515 of the screw 502 can be configured to accept the bolt 511. When the bolt 511 is moved inside the hollow tube structure, as shown in
In one embodiment, when the bolt has been inserted a predetermined distance into the hollow tube structure, the distal end of the implantable retention device can be configured to detach the screw-activated device.
As can be seen from
Various methods of using the woven retention device can be used.
In one embodiment, in step S400, a bone can be drilled to form a bone hole. In one embodiment, the woven retention device can be elongated or constricted in step S402, after which in step S404 the woven retention device can be inserted into the bone hole. After step S404, in step S406 the woven retention device upon entering the bone hole can be expanded. Thus, upon entering the bone hole, the woven retention device can expand to a less elongated and constricted state to interface with the bone surface. After step S406, in step S408 the fastener can be inserted into the woven retention device either before or after insertion into the bone hole. Next, the fastener can exert pressure on an interior of the woven retention device in step S410. In step S410, the fastener can optionally change the shape of the interior of the woven retention device. Next, in step S412, pressure from an interior of the woven retention device can be distributed to an exterior surface of the woven retention device. In step S412, the shape of the exterior surface of the woven retention device can optionally change shape. In step S414, pressure from an exterior surface of the woven retention device can transmit to bone surface. In step S414, the pressure transmission to the bone surface can optionally change the shape of the bone surface. In other embodiments, the steps can be performed in different orders or steps can be optionally omitted.
In another embodiment, instead of following steps S402, S404, S406 and S408, in step S401, a fastener can be inserted into the woven retention device before the woven retention device has been inserted into the bone hole, after which in step S403 the fastener with woven retention device can be inserted into the bone hole. After step S403, in step S410 the fastener can optionally change the shape of the interior of the woven retention device. Next, in step S412, pressure from an interior of the woven retention device can be distributed to an exterior surface of the woven retention device. In step S412, the shape of the exterior surface of the woven retention device can optionally change shape. In step S414, pressure from an exterior surface of the woven retention device can transmit to bone surface. In step S414, the pressure transmission to the bone surface can optionally change the shape of the bone surface.
In another embodiment, the distributing pressure step comprises dynamic micro-loading of the woven retention device based on differences in loading patterns of the woven retention device and the interfacing surface shape of the fastener. Based on a uniform radial distribution of the woven retention device, a different loading pattern, or in other words, a dynamic load, is possible. That is, instead of solely pushing or cutting bone, the fastener can deform the woven structure. Further, based on the flexibility of the weave, the woven retention device can facilitate an even distribution of load on uneven bone structure.
In one embodiment, the woven patch can allow for dynamic micro-loading of the woven patch against the bone surface such that the woven patch expands or contracts in thickness based on pressures exerted on the woven patch. In another embodiment, bone cement can be applied to the woven patch to secure the woven patch to the bone. The bone cement can facilitate filling in space between the bone surface and the woven patch, in addition to securing the woven patch to the bone. In an embodiment, the woven patch can serve as a scaffold to encapsulate a fastener.
Thus, a fastener can be inserted into the woven retention device either before or after the woven retention device is inserted into the bone hole. Upon being inserted into the woven retention device, the fastener can exert a pressure on an interior surface of the woven retention device, which can optionally change the shape of the interior surface. The pressure exerted on the interior surface of the woven retention device can distribute pressure to an exterior surface of the woven retention device, which can optionally change the shape of the exterior surface. The change in the exterior surface can allow for better interfacing with the bone surface based on the changes to the exterior surface. The bone surface can optionally change shape based on the pressure that is applied by the woven retention device.
The woven retention device can be beneficial for use with low bone mineral density, which is the amount of mineral matter per square centimeter of bone that is between 1 and 2.5 standard deviations away from young normal adult. Low bone mineral density can include osteoporosis, osteopenia, hyperparathyroidism and/or osteomalacia. A notable part of the woven retention device's interior surface is its ability to engage with the screw without having a matching threaded surface on the interior in a preferred embodiment. The material of the woven retention device can be made of any plastic or fiber. Other materials can also be used, including metallic and natural or biological materials.
The dual interface can be achieved through having a tube-shaped, braided retention device with sufficient rigidity, stability (returning to the woven retention device's original shape or configuration after deformation), and tensile strength when a screw can be inserted to provide sufficient sheer strength to a screw on the one side and a uniform and distributed pressure to the bone on the other side. The woven retention device can have a multi-filament comprising a one-under/one-over arrangement of 45 degree angle intersections and a mono filament that runs adjacent to each of the braids such that each filament goes over two other filaments before going under two filaments (2-over/2-under, twill or herringbone). A three-under/three-over arrangement can also be possible. Other types of weaves are possible (including only a monofilament) as long as there can be sufficient stability, rigidity, compressibility, sheer strength, and/or tensile strength.
The Young's modulus (or load modulus) can also be used to quantify the woven retention device according to some embodiments. In one embodiment, there can be two portions associated with the response of the woven retention device shape upon exertion of pressure from the fastener and upon interfacing with the bony surface. For example, there can be a linear portion to the response curve (stress over strain curve), and there can be a non-linear portion where the material stops behaving elastically. If the material/structure exhibits the linear response over the range of the test (i.e., the amount of stretching performed on the sample), then the sample is “linear.” The amount of stretching performed on the sample is typically an amount of stretching that the sample can be expected to experience in use because all samples will exhibit non-linear response eventually. If the sample exhibits the non-linear response within the test range, the sample can be “non-linear”. In one embodiment, the Young's modulus of the woven retention device can be substantially linear over the load range of the fastener. In another embodiment, the Young's modulus of the woven retention device can be non-linear over the load range.
One configuration of the interlaced filaments can be at a 45 degree braid angle in relation to the axis of the retention device in the position after the woven retention device can be inserted into the hole. Such a braid angle allows for maximum distribution of the protuberances on the exterior surface of the tubular lattice. Other angles are also preferably contemplated to be between 40-50 degree braid angles relative to the retention device longitudinal axis. The woven retention device diameter can be dynamically determined depending on the size of pilot hole diameter such that braid angles are 45 degrees when in hole (which can be less critical for larger screws).
In one embodiment, the woven retention device can be shaped like a hollow rope. In another embodiment, the woven retention device does not require that the filaments be interwoven provided that other characteristics of the filaments provide for a sufficiently rigid and flexible lattice. For example, a retention device for interfacing with a bone surface can include a sleeve body comprising a plurality of intersecting filaments forming a substantially tubular wall, the tubular wall having an interior surface and an exterior surface, the sleeve body being configured to surround at least a portion of a fastener on an interior surface-side of the tubular wall. The retention device can also include a proximal end and a distal end, the sleeve body extending between the proximal and distal ends. The retention device can also include a plurality of protuberances distributed on the tubular wall, each of the plurality of protuberances being formed by intersecting two or more of the plurality of intersecting filaments.
In the retention device, the plurality of intersecting filaments can include a plurality of filament cross-section geometries. Further, the plurality of protuberances can have a plurality of protuberance thicknesses based on a plurality of combinations of the filament cross-section geometries, where a thickness of each of the plurality of protuberances can be based on a particular combination of the plurality of filament cross-section geometries at the intersection point, and the thickness being measured in a radial direction of the sleeve body. In the retention device, the sleeve body, when surrounding at least a portion of the fastener, can be configured to distribute pressure from the fastener on the interior surface-side of a protuberance to an exterior surface-side of two or more protuberances, and the plurality of protuberance thicknesses accommodate deviations in the bone surface. In an alternative configuration, the sleeve body can be configured to distribute pressure from the fastener on the interior surface side of a protuberance to an exterior surface-side of one protuberance having more than one force.
A retention device can include a substantially tubular lattice of intersecting fibers that can be configured to be inserted into a bone tunnel, the tubular lattice including a proximal end and a distal end, the proximal end having a receiving portion that can be configured to receive a fastener along a longitudinal axis of the retention device, wherein: the tubular lattice includes an interior surface that has a distributed interface with protruding and recessed portions that are configured to interact with an exterior surface of the fastener, the tubular lattice includes an exterior surface that has protruding and recessed multiple points of contact configured to interact with an interior bone surface, and the tubular lattice has a degree of stability that maintains a three-dimensional structure of the tubular lattice and has a degree of flexibility, the degree of stability and flexibility allowing for the distributed interface of the interior surface to distribute applied pressure to the protruding and recessed multiple points of contact of the exterior surface, the pressure resulting from the fastener being inserted.
According to embodiments of the invention, the woven retention device can enhance pullout force percentage compared with a screw alone for a range of hole diameters. However, the woven retention device used with a small screw may allow for a higher percentage increase of pullout force than with medium and large screws. For example, the woven retention device according to an embodiment has been shown to add at least a 10% increase in pullout strength compared with the pullout force of a screw without a woven retention device. Specifically, for small hole diameters, the increase has been shown to be 33% to 77%, according to an example of one embodiment. For medium hole diameters, the increase has been shown to be 10% to 72%, according to another example of an embodiment. Finally, for large hole diameters, the increase has been shown to be 12% to 30% according to another example of an embodiment.
Examples of woven retention devices according to embodiments were fabricated using different combinations of filaments. Table 1 shows details of the five versions of these examples. Each version includes two types of counter clockwise filaments, and two types of clockwise filaments. “Type” refers to whether the filament is mono-filament or multi-filament. “Size” indicates the diameter (measured in millimeters) of the monofilaments, and the linear mass density (measured in decitex, or dtex, which is grams per 10,000 meters) for the multifilament. “# of Carriers” refers to the number of each filament. Version 1 is a combination of mono- and multifilaments. Version 2 is only monofilaments, where the monofilaments are all the same size. Version 3 is a combination of two different sizes of monofilaments. Version 4 is a combination of three different sizes of monofilaments. The woven retention devices in Versions 1-5 each had a braid angle of about 40° to 45°, and were sized to accommodate screw with an inner core diameter of about 6.5 mm (corresponding to the “large” size discussed above). The filaments were made of polyethylene terephthalate (PET).
The lattice can further include a distal end that is distal to the sleeve body. The sleeve body can have a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments. The plurality of combinations of filament cross-section geometries can form a plurality of different protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In an implanted state of the woven retention device, the tubular lattice can be configured to interface with both the soft tissue and the bone surface to secure the soft tissue 705 to the bone surface. The spatial relationship of the protuberances can change according to a function of bone density.
The lattice can further include an anchoring device 711 that is configured to apply pressure to one or more regions of the soft tissue. The sleeve body can distribute the applied pressure through the soft tissue and the bone surface.
The anchoring device 711 can penetrate the soft tissue and protrude into the bone surface. The filaments can be interwoven filaments and the interwoven filaments include at least one set of filament that is a felted filament. The sleeve body can include felted filaments. The sleeve body can include an orthopedic biomaterial, and the sleeve body can be configured to minimize biofilm formation on the bone and/or soft tissue.
In another embodiment, the method and apparatus for creating the retention device can be performed by 3D printing to create a porous structure that has raised points of multiple contacts on the inside and the outside. The 3D printing technique can also be used to create a weave or braid structure. A computer readable storage medium having data stored thereon can be executed by a computer processor to cause a computer to perform certain steps that result in a three-dimensional retention device structure.
With 3D printing, it is possible to orient individual polymer molecules or polymer particles such that if one thinks of fibers, just one long continuous polymer material, a relationship between one fiber and another can be separated without the fibers fusing together. Thus, a resulting structure is possible that functions just like a woven retention device. The files used in the 3D printing process may use sophisticated arithmetic in terms of how the polymer material is set up. For example, a process of felting may include taking fibers and inter-relating fibers to create a fabric. The felting process can be based off of nitinol technology such as long continuous fibers (e.g., wires) of nitinol in a generally mesh-like structure that possesses a lattice of fibers with a variety of apertures. There are other means and methods to approach this that are not necessarily woven or braided that may result in a similar mesh-like configuration. In a process similar to felting, another embodiment includes taking small fibers and turning them into a matrix and then putting other fibers together not in a woven pattern, but in a random way that could end up creating a variety of protuberances. Thus, 3D printing can be used as a basis of producing embodiments that disclose multi-dimensional protuberances.
In some embodiments, 3D printing can be used in varying the thickness of the fiber along the length of the fiber so that very specific protuberances, geometries, or distributions of protuberances are possible. Thus, rather than have one thick fiber and a smaller fiber that have a uniform thickness across the length of the device, a fiber that is thick in one portion of the fiber or along multiple portions of that fiber makes it possible to vary wall thickness along the length, and vary localized protuberance thicknesses to create very specific geometries and mechanical performance.
In some embodiments, a non-transitory computer-readable storage medium can have data thereon representing a three-dimensional model suitable for use in manufacturing a three-dimensional retention device 100 for interfacing with a bone surface 104. The non-transitory computer-readable storage medium, when executed by at least one processor, can cause a computing system to use the data in forming the three-dimensional retention device to create a plurality of filaments having input regions that interlace with other filaments. The retention device can include: a sleeve body comprising a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body can be configured to surround at least a portion of a fastener. Each of the plurality of protuberances can be formed by an intersection point of two or more of the plurality of filaments. The sleeve body can include an orthopedic biomaterial. The woven retention device can include a proximal end that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener; and a distal end that is distal to the sleeve body.
In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at the intersection points. The plurality of combinations of filament cross-section geometries can form a plurality of protuberance thicknesses. A thickness of each protuberance can be measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener can be transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
In some embodiments, the woven retention device 100 can include an orthopedic biomaterial that stimulates bone growth. Biomaterials in orthopedics can be made of biocompatible, biofunctional, non-toxic, machinable, moldable, extrudable, having tensile strength, yield strength, elastic modulus, corrosion and fatigue resistance, surface finish, creep, hardness. See Patel and Gohil, “A Review on Biomaterials: Scope, Applications & Human Anatomy Significance,” International Journal of Emerging Technology and Advanced Engineering 2(4): pp. 91-93 (April 2012) (Patel), the content of which is hereby incorporated herein by reference in its entirety. For example, the interwoven filaments can include biomaterials and the biomaterials can be manufactured in fiber format. The woven or non-woven structures described above can be made of non-resorbable or bioabsorbable polymers, metals, biological products or ceramics. Bio resorbable polymer material can be used. For example, the sleeve material can be bioabsorbable and dissolve for complete healing, reduced risk of particulate debris, and have no removal complications as a result. The bioabsorbable polymer can include at least one of thermoplastic aliphatic polyester (PLA), polyglycolide (PGA), polylactide (PLLA) and resorbable polyamides. Alternatively, the sleeve material does not degrade but stays as a structural support of the bone. A non-resolvable polymer material can be biologically suited for use in bone, such as PET (polyehthylene terephthalate), ultra high molecular weight polyethylene, polyether etherketone (PEEK), polyether ketoneketone (PEKK), polypropylene, polyamides, PTFE, calcium phosphate and variations of sutures.
A hydrophilic biomaterial such as a metal can be hydrophilic and attract bone. In one embodiment, metals can also be used such as titanium, tantalum, nickel titanium (nitinol), platinum, cobalt chrome/cobalt chromium, or a blend of all the listed metals. For example, the metals can include at least one of nickel-titanium (Ni—Ti) or nitinol, stainless steel, platinum, titanium, cobalt chrome, cobalt chromium, or any combination thereof. In an embodiment, the metal material can be roughened to create a roughness characteristic that attracts bone, or encourage bone to grow to it or group to it. In an embodiment, the biomaterial such as a metal can have a radioactive property such that the biomaterial can be detected using electromagnetic radiation, such as X-rays. In one embodiment, the woven retention device can be made of fibers of a bone-promoting biomaterial in combination with fibers of a material that does not promote bone growth. For example, the woven retention device can be made of fibers of titanium, which promotes bone growth, as well as PEEK, which promotes bone growth less. Additionally, fibers of PEKK, which can promote bone growth, can be used in combination with titanium and PEEK. In one embodiment, the filaments can include porous fibers.
In an embodiment, the woven retention device can be constructed with an interior surface having a tap of the metallic biomaterial that follows the path of a fastener such as a screw. In such a configuration, the woven retention device is self-tapped to receive an insert, and as the screw follows the path, the woven retention device is configured to expand. In one embodiment, the self-tapping can be produced through the weaving pattern of the fibers or through a mechanical inscribing process that machines thread that matches to the material into which the woven retention device is being inserted. For example, one metal fiber can be included among all other plastic fibers and based on the pitch of the screw, the metal fiber can be designed to follow the tap of the screw.
Biological materials or biologics, such as silk, collagen, and cat gut suture can be used. See Park and Lakes, “Biomaterials: An Introduction,” 1992, Chapter 4 (Park), the content of which is hereby incorporated by reference herein in its entirety. The biological products can include at least one of silk and collagen. Thus, the sleeve can be made of sheet fabric materials such as Silk or Felt that is not woven, but could be created by using collagen. An interior surface could be configured to interface with different structures besides a screw (clamp, smooth, roughened) to provide a strong connection as long as there are many points of contact to provide sufficient sheer strength and a monolithic structure (that is, if one point fails, whole structure does not fail).
In some embodiments, ceramic materials can be used (or bioceramics), which are inert, strong in compression, and biocompatible, such as aluminum oxide, calcium phosphate (hydroxyapatite). See Patel, page 96. For example, the sleeve material can be made of bioactive glass ceramics. See Park chapter 3. The sleeve materials can have bone regenerative qualities (bony apposition).
In some embodiments, the woven retention device 100 can include sleeve materials applied to the woven retention device 100. For example, structural integrity of the woven retention device can be a non-resorbable material, for example PET or PEEK fiber. And the woven retention device is then interlaced with a biologic fiber, such as collagen, to attract or stimulate the bone. Thus, in an embodiment, biological fibers need not provide structural or fixation support, but instead locally stimulate bone formation. Alternatively, the woven retention device can include can include all synthetic materials as non-resorbable materials and instead of interlacing biological fibers, the woven retention device can be coated with an osteostimulative agent.
Instead of a flat fiber, a rougher or pillowy surface is also possible. In an embodiment with a monofilament/multifilament, a textured fiber instead of a flat multifilament could absorb or wick up more biological agent. In one embodiment, the woven retention device can be biofriendly and have a wicking characteristic to absorb plasma-rich platelets. As an example, a method of treating cancer or stimulating bone growth can include as a first step manufacturing a retention device having from plastic or from a biomaterial. The second step can include taking a patient's own blood, spinning it, supercharging it, extracting platelet-rich-plasma, and putting the blood back into the patient. The third step can include dipping the manufactured retention device into the extracted platelet-rich-plasma to coat the retention device. A next step can include inserting the coated retention device into the patient.
Alternatively, or additionally, the manufactured retention device can be inserted into the patient before coating of at least one application of platelet-rich-plasma, and after insertion, the retention device can be injected with the platelet-rich-plasma and the retention device wicks up the platelet-rich-plasma. The step of coating the retention device can take place in the operation room by a professional. In one embodiment, the fibers that work well with the platelet-rich-plasma can be bio friendly and have a wicking characteristic to absorb the platelet-rich-plasma. Thus, in one embodiment, a unique fiber or conventional fiber that is texturized multifilament type of device or a combination of different fibers allow for wicking. Alternatively, an agent could come prepackaged with the retention device, e.g., that is dipped in something before it is inserted and soaked up. Alternatively, the agent could be applied internally and the retention device can wick the agent in situ.
In some embodiments, a combination of natural and synthetic fibers can be used in the manufacturing process of the retention device. For example, a structural piece can be used along with an agent either to stimulate bone to release some kind of therapeutic, to combat an infection, prevent an infection, act as a pain medication, act as a stimulant for bone growth. The stimulant for bone growth can be naturally-occurring, patient's own blood or synthetic, like a hormone.
The sleeve materials can have antibiotic or anti-microbial properties to reduce infections and enhance effectiveness. The woven retention device can be made of a metal that slowly releases ions over time that has anti-microbial properties. Some materials alone have antimicrobial properties. Naturally occurring Silver, for example, can be used as an anti-microbial agent. Thus, impregnating Silver with PEEK can provide an anti-microbial property. Other materials, including metals and polymers, can have anti-microbial properties in combination with other materials. The sleeve material can have drug eluting properties to stimulate bone growth and improve recovery time. And it can be provided at the local level instead of at the systemic level. The sleeve material can also be bioconductive meaning that an allograph fixation sleeve can be made using allographic tissue to create a bone based fixation sleeve in combination with long fiber bone tissue processed by Osteotech, now owned by Medtronic. The allographic tissue can be made out of different material (human based material).
Biofilm
There is a need for devices, systems and methods that enhance the surface of a bone hole to provide enhanced fixation of a bone anchor to the bone. Additionally, there is a need for devices, systems and methods for repairing the surface of the bone hole following damage to the bone hole as in the case of stripping of the hole in the bone when a bone screw is over-tightened. Also, there is a need for devices, systems and methods for providing an enhanced bone hole surface for the reattachment of tendons in, for example anterior/posterior cruciate ligament repair procedures, rotator cuff repair procedures, etc. There is a need for a device that enhances the surface of a bone hole to enhance fixation of a bone anchor to bone and permits bone ingrowth into its structure. There is a need for a single device that enhances the surface of a bone hole to enhance fixation of a bone anchor to bone and accommodates variations in the diameter and depth of the bone hole. Further, there is a need for such devices that have enhanced biocompatibility to aid in tissue and bone healing, regeneration, and growth.
According to an embodiment of the present invention, a retention device for interfacing with a bone surface and impeding biofilm development is provided. The retention device includes a sleeve body including a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body can surround at least a portion of a fastener, and each of the plurality of protuberances may be formed by an intersection point of two or more of the plurality of filaments that outline a plurality of apertures. The filaments can include an orthopedic biomaterial. The retention device also may include a proximal end that is proximal to the sleeve body and that can receive at least a portion of the fastener, and a distal end that is distal to the sleeve body. In a first state, the sleeve body may have a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses. A thickness of each protuberance is measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener can be transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
In an aspect of an embodiment, the retention device can be a woven retention device and the filaments may be interwoven. The orthopedic biomaterial can include a hydrophilic material that attracts bone growth, and the hydrophilic material can be a metal. The orthopedic biomaterial can include non-resorbable polymer fibers. The orthopedic biomaterial can include at least one of osteostimulative, antimicrobial, and plasma-rich-platelet (PRP) agents applied to the filaments. In an embodiment, the non-resorbable polymer fibers are roughened to wick one of osteostimulative, antimicrobial and plasma-rich-platelet agents. The orthopedic biomaterial may include biologic fibers that are configured to absorb into a body, and the non-resorbable polymer fiber and the biologic fibers may be interwoven.
In an embodiment, the interior surface of the retention device can be tapped and can allow for substantially uniformly expanding the sleeve body as the fastener is inserted. In an aspect of an embodiment, the retention device is a non-woven retention device and wherein the sleeve body comprises at least one of silk, felt and collagen.
In an embodiment, the interwoven filaments can include a first plurality of monofilaments that runs in a first helical direction and a second plurality of monofilaments that runs in a direction intersecting the first plurality of monofilaments. For each set of the first and second plurality of monofilaments, there may be a substantially same arrangement of cross-section geometries at every other intersection along that set, the substantially same arrangement being different from an arrangement of cross-section geometries at remaining intersections along that set.
In an embodiment, the retention device may further include a first plurality of multifilaments that runs in the first helical direction and a second plurality of multifilaments that runs in the second direction, the first plurality of monofilaments and the first plurality of multifilaments forming a first plurality of sets of filaments and the second plurality of monofilaments and the second plurality of multifilaments forming a second plurality of sets of filaments. Each of the first plurality of sets of filaments can include a first outer filament and a first inner filament, and each of the second plurality of sets of filaments can include a second outer filament and a second inner filament. The first plurality of monofilaments may be thinner in diameter than the second plurality of monofilaments. The interwoven filaments may follow a two-under/two-over configuration, where at each intersection, the second plurality of monofilaments either overlies both of the intersecting monofilaments or is overlain by both of the intersecting monofilaments and the second plurality of monofilaments overlies one of the intersecting filaments and is overlain by the other of the intersecting filaments.
In an aspect of an embodiment, the first plurality of monofilaments may have a diameter in a range of about 0.1 mm-0.4 mm. The first plurality of monofilaments may have a diameter of 0.2 mm.
The braid angle of the filaments can intersect at approximately 45 degrees. In an embodiment, the orthopedic biomaterial may include a bioresorbable polymer that is configured to at least partially dissolve or be absorbed in the body.
In an aspect of an embodiment, the plurality of apertures of the retention device includes a plurality of differently shaped apertures.
Screw-Activated
In one aspect, an implantable retention device for interfacing with a bone tissue and a fastener can include a hollow tube structure having a proximal end, a distal end, and a body that extends between the proximal and distal ends. The body can have porosity arranged to allow for bone ingrowth from the bone tissue. The body can include an interior surface configured to interface with the fastener and the interior surface can define a first inner diameter in a resting state of the hollow tube structure. The body can include an exterior surface configured to interface with the bone tissue. The hollow tube structure can be configured to uniformly radially compress along at least a portion of the body into a constricted state, and the interior surface can be configured to define a second inner diameter in the constricted state that is smaller than the first inner diameter. The hollow tube structure can be configured to uniformly radially expand along at least a portion of the body into an expanded state, and the interior surface can define a third inner diameter in the expanded state that is larger than the first inner diameter. The implantable retention device can have a degree of flexibility and stability such that, in the constricted state and in the expanded state, the body is biased to return to the resting state.
The implantable retention device can have a shear strength along an axis substantially orthogonal to a longitudinal axis of the hollow tube structure such that the hollow tube structure resists shearing from surface areas of the bone tissue and the fastener up to a predetermined threshold when the fastener is inserted into the bone hole.
The degree of flexibility of the implantable retention device can allow for the hollow tube structure to change to a contorted state when the fastener is inserted. The contorted state can be different than the resting state, the constricted state and the expanded state. In the contorted state, at least portions of the body can interdigitate with variations in a surface of the fastener. When implanted into the bone hole and in the contorted state, at least portions of the body can interdigitate with the bone tissue.
The body can further include a plurality of engagement sites on the exterior and interior surfaces of the body that interact with a surface of the bone tissue and a surface of the fastener, respectively. The plurality of engagement sites can exert a plurality of retaining forces on the surface of the bone and the surface of the fastener to resist removal of the fastener from the implantable retention device and to resist removal of the implantable retention device from the bone. The implantable retention device can be configured such that when an engagement site fails to exert a sufficient retaining force, others of the plurality of points of contact compensate for the failed engagement site. The implantable retention device can be monolithic. The engagement sites can include elements that are raised relative to the exterior and interior surfaces of the body.
A tensile force applied to the hollow tube structure parallel to a longitudinal axis of the hollow tube structure can cause the hollow tube structure to radially constrict and the compressive force applied to the hollow tube structure parallel to the longitudinal axis of the hollow tube structure can cause the hollow tube structure to expand.
A torque in a first direction about the longitudinal axis of the hollow tube body can cause the hollow tube body to radially constrict.
The implantable retention device can further include a screw-activated device including i) a screw having a threaded portion and ii) a bolt that is configured to be threaded along the threaded portion of the screw. A first end of the screw can be attached to the distal end of the implantable retention device and at least a portion of the threaded portion runs along a longitudinal direction of the body inside the implantable retention device. A second end of the screw can be configured to accept the bolt such that when the bolt is moved inside the hollow tube structure, a compressive force is exerted on the implantable retention device by the bolt in a direction parallel to a longitudinal axis of the hollow tube structure. The compressive force radially can expand the hollow tube structure to the expanded state. When the fastener is inserted a predetermined distance into the hollow tube structure, the proximal end of the implantable retention device can be configured to detach from the fastener.
The retention device can be made of at least one of silk, non-woven felt, and collagen.
The fastener can be a screw. The fastener can include a smooth or roughened clamp. The distal end can be tapered.
In another aspect, an implantable retention device for interfacing with a bone tissue and a fastener can include a hollow tube structure having a proximal end, a distal end, and a body that extends between the proximal and distal ends. The body can have porosity arranged to allow for bone ingrowth from the bone tissue. The body can include an interior surface configured to interface with the fastener, where the interior surface can define a first inner diameter in a resting state of the hollow tube structure. The body can further include an exterior surface configured to interface with the bone tissue. The hollow tube structure can be configured to uniformly radially compress along at least a portion of the body into a constricted state, and the interior surface can define a second inner diameter in the constricted state that is smaller than the first inner diameter. The hollow tube structure can be configured to uniformly radially expand along at least a portion of the body into an expanded state, and the interior surface can define a third inner diameter in the expanded state that is larger than the first inner diameter. The implantable retention device can have a degree of flexibility and stability such that, in the constricted state and in the expanded state, the body is biased to return to the resting state.
Soft Tissue
According to an embodiment of the invention, a woven retention device for securing soft tissue relative a bone surface is provided. The woven retention system may include a woven retention device that includes a sleeve body, a proximal end, and a distal end. The sleeve body includes a plurality of interwoven filaments that form a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The plurality of interwoven filaments may have a plurality of different filament diameters. The proximal end of the woven retention device is proximal to the sleeve body and may be able to receive at least one of a fastener and at least a portion of the soft tissue. The distal end of the woven retention device is distal to the sleeve body. The sleeve body may have a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments. The plurality of combinations of filament cross-section geometries can form a plurality of different protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In an implanted state of the woven retention device, the tubular lattice can interface with both the soft tissue and the bone surface to secure the soft tissue to the bone surface, and the spatial relationship of the protuberances can change according to a function of bone density.
The woven retention system may further include an anchoring device that can apply pressure to one or more regions of the soft tissue, the sleeve body distributing the applied pressure through the soft tissue and the bone surface. In some embodiments, the anchoring device may penetrate the soft tissue and protrude into the bone surface. The anchoring device can be a tack, a suture, a screw, a bone dowel, or a nail.
According to some embodiments, the woven retention system may further include a fastener that can be implanted into a bone. The soft tissue, sleeve body and the fastener may be extended at least partially through a bone tunnel. The fastener may be a screw having a screw thread and at least one of the exterior surface and the interior surface of the tubular lattice may interact with the screw.
In some embodiments, the plurality of interwoven filaments includes a first plurality of filaments that runs in a first helical direction and a second plurality of filaments that runs in a direction intersecting the first plurality of filaments. Each of the first and second plurality of filaments can include a plurality of sets of filaments, and for each of the sets of filaments, there may be a substantially same arrangement of cross-section geometries at every other intersection along that set, the substantially same arrangement being different from an arrangement of cross-section geometries at remaining intersections along that set. Each set of the plurality of sets of filaments may include at least two filaments of the plurality of interwoven filaments, where the at least two filaments may be substantially parallel to each other and being spaced closer to each other than to filaments in an adjacent set of the plurality of sets of filaments. Each of the sets of filaments may include at least one monofilament. Each of the sets of filaments may also include at least one multifilament. In some embodiments, the first plurality of filaments includes monofilaments having a smaller diameter than a diameter of monofilaments in the second plurality of filaments.
The plurality of interwoven filaments may follow a two-under/two-over configuration, where at each intersection, a first filament of a set of the second plurality of filaments either overlies both filaments of a set of the first plurality of filaments or is overlain by both the filaments of the set of the first plurality of filaments, and a second filament of the set of the second plurality of filaments overlies one of the filaments of the set of the first plurality of filaments and is overlain by another of the filaments of the set of the first plurality of filaments. The plurality of interwoven filaments may include a plurality of flat multifilaments.
The interwoven filaments can outline interstices arranged to allow for bone ingrowth, and the interstices can be differently shaped and differently sized interstices. In a relaxed state, the interwoven filaments may extend around the tubular lattice at an angle in a range of about 40-60 degrees with respect to a longitudinal direction of the woven retention device. In the relaxed state, the interwoven filaments may extend around the tubular lattice at an angle of about 45 degrees with respect to the longitudinal direction of the woven retention device. In some embodiments, the distributed protuberances are arranged in a diamond-shaped pattern grid.
According to some embodiments, the tubular lattice has an outer radius spanning from a furthest outwardly extending protuberance in the radial direction on the exterior surface of the tubular lattice to a center point of the tubular lattice. The tubular lattice may have an inner radius spanning from a furthest inwardly protruding protuberance in the axial direction on the interior surface of the tubular lattice to the center point of the tubular lattice. The tubular lattice may have an average radius that is an average between the outer radius and the inner radius. The outer radius of the tubular lattice is greatest at the intersection point of two filaments of greatest diameter.
In some embodiments, the tubular lattice can transfer pressure applied by the fastener to at least one point on the interior surface to protuberances on the exterior surface adjacent to the at least one point, such that the exterior surface exerts pressure on at least one of bone material and the soft tissue. At least one of the woven retention device and the anchoring device may be made of a resorbable material that resorbs into surrounding tissue over time. The interior surface of the sleeve body can be smoother than the exterior surface of the sleeve body. The interwoven filaments may be made of one or more of silk, collagen, and cat gut suture.
The woven retention system may further include a fastener that can be inserted at least partially within an interior of the tubular lattice through the proximal end. The woven retention device can fix at least a portion of the soft tissue between the exterior surface and the bone surface by transmitting pressure from the fastener on the interior surface to the exterior surface adjacent to the at least a portion of the soft tissue. The fastener may also transmit pressure from the interior surface to the exterior surface adjacent to the bone surface. The fastener may be able to be inserted into a bone hole, and the woven retention device can be used to fix at least a portion of the soft tissue relative to the bone surface by transferring pressure from the fastener on the exterior surface through the soft tissue and portion of the exterior surface adjacent to the bone surface while the at least a portion of the soft tissue is within an interior of the tubular lattice.
According to an embodiment of the invention, a method of anchoring soft tissue using a woven retention system is provided. The method can include providing a sleeve body having a plurality of sets of interwoven filaments that form a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The plurality of sets of interwoven filaments may have a plurality of different diameters. The method can further include surrounding at least a portion of soft tissue with the sleeve body. The method may also include applying pressure from an anchoring device to the surrounded portion of soft tissue, the woven retention device transmitting the applied pressure from a surface of the woven retention device to a surface of the bone surface of the bone hole according to a function of bone density and according to a function of an interfacing surface shape of the anchoring device, In a first state, the sleeve body may have a plurality of combinations of filament cross-section geometries at the intersection points. The plurality of combinations of filament cross-section geometries can form a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances may change according to a function of bone density and according to a function of an interfacing surface shape of the fastener. The pressure from the anchoring device changes the spatial relationship of protuberances on the interior surface of the woven retention device, and the pressure from the interior surface changes the spatial relationship of protuberances of the exterior surface of the woven retention device.
In some embodiments, the applying of the pressure includes penetrating the anchoring device through the soft tissue and into the bone surface. The anchoring device can be one of a tack, a suture, a screw, a bone dowel, and a nail. The anchoring device can be made of a resorbable material that resorbs into surrounding tissue over time.
The method may further include providing a fastener to which the anchoring device applies the pressure. The soft tissue, sleeve body and the fastener may be extended at least partially through a bone tunnel. In some embodiments, the interior surface of the sleeve body is smoother than the exterior surface of the sleeve body such that the sleeve body is adapted to interface with the soft tissue and bone surface. The interwoven filaments can be made of one or more of silk, collagen, and cat gut suture.
According to an embodiment of the invention, a method of anchoring soft tissue using a woven retention system is provided. The method includes providing a sleeve body having a plurality of sets of interwoven filaments that form a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The plurality of sets of interwoven filaments may have a plurality of different diameters. The method may further include inserting the sleeve body and at least a portion of the soft tissue into a bone hole, the portion of the soft tissue being adjacent to the exterior surface of the tubular lattice in the bone hole. The method may also include applying pressure from a fastener inside the sleeve body to the portion of the soft tissue that is adjacent to the exterior surface, the woven retention device transmitting the applied pressure from at least a portion of the exterior surface to a surface of the bone hole according to a function of bone density and according to a function of an interfacing surface shape of the fastener. In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at the intersection points. The plurality of combinations of filament cross-section geometries can form a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In a second state when the fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener. The pressure from the anchoring device can change the spatial relationship of protuberances on the interior surface of the woven retention device, and the pressure from the interior surface can change the spatial relationship of protuberances of the exterior surface of the woven retention device.
Patch
According to one embodiment of the present invention, a woven patch for interfacing with a bone surface is provided. The patch includes a sleeve body including a plurality of sets of interwoven filaments that form a lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the lattice at a predetermined spatial relationship, the plurality of sets of interwoven monofilaments having a plurality of different diameters. The sleeve body can surround at least a portion of a fastener. The patch also may include a first end that can interface with at least a portion of the fastener, and a second end that is opposite of the first end to the sleeve body. In a first state, the sleeve body may have a plurality of combinations of filament cross-section geometries at intersection points of the interwoven filaments, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses. A thickness of each protuberance may be measured in a direction as a thickness of the sleeve body. In a second state, when a fastener is inserted into or applied to the lattice, pressure from the fastener is transmitted to the lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
In an aspect of an embodiment of the present invention, the plurality of sets of interwoven filaments includes a first plurality of monofilaments that runs in a first direction and a second plurality of monofilaments that runs in a direction intersecting the first plurality of monofilaments. For each set of the first and second plurality of monofilaments, there may be a substantially same arrangement of cross-section geometries at every other intersection along that set. The substantially same arrangement can be different from an arrangement of cross-section geometries at remaining intersections along that set. In an embodiment, the first end has a distal tip with a first diameter, and the receiving portion has a second diameter that is greater than the first diameter.
In an aspect of an embodiment, the patch further includes a first plurality of multifilaments that runs in the first direction and a second plurality of multifilaments that runs in the second direction. The first plurality of monofilaments and the first plurality of multifilaments forming a first plurality of sets of filaments and the second plurality of monofilaments and the second plurality of multifilaments forming a second plurality of sets of filaments. Each of the first plurality of sets of filaments can include a first outer filament and a first inner filament, and each of the second plurality of sets of filaments can include a second outer filament and a second inner filament. In an embodiment, the first plurality of monofilaments are thinner in diameter than the second plurality of monofilaments. In a further embodiment, the plurality of interwoven filaments follow a two-under/two-over configuration, where at each intersection, the second plurality of monofilaments either overlies both of the intersecting monofilaments or is overlain by both of the intersecting monofilaments and the second plurality of monofilaments overlies one of the intersecting filaments and is overlain by the other of the intersecting filaments. The first plurality of monofilaments may have a diameter in a range of about 0.1 mm-0.4 mm. The first plurality of monofilaments may have a diameter of 0.2 mm. In an aspect of an embodiment, the plurality of interwoven filaments may include a plurality of flat multifilaments.
In an embodiment, the interwoven filaments outline interstices that allow for bone ingrowth, and the interstices formed by the intersecting filaments include differently shaped and differently sized interstices. The plurality of interwoven filaments may be arranged in a two-under/two-over configuration. In another embodiment, the plurality of interwoven filaments may be arranged in a one-under/one-over configuration. In yet another embodiment, the plurality of interwoven filaments may be arranged in a two-over/one-under configuration. In a further embodiment, the plurality of interwoven filaments may be arranged in a three-under/three-over configuration.
In an aspect of an embodiment, the woven patch can further include the fastener. The fastener can be a screw having a screw thread and the interior surface is configured to interact with the screw. The fastener can apply pressure to the interior surface, the pressure being transmitted to protuberances on the exterior surface adjacent to the protuberance on the exterior surface that interior surface and exerting pressure on bone material.
In an embodiment, the interwoven filaments extend around the lattice at an angle of about 45 degrees with respect to a parallel direction of the woven patch. The distributed protuberances may be arranged in a diamond-shaped pattern grid. The woven patch may have a length in a range from about 30 mm to 40 mm.
In another embodiment of the present invention, a patch for interfacing with a bone surface is provided. The patch includes a lattice of intersecting fibers that can be inserted into a bone tunnel, the lattice including a proximal end and a distal end, the proximal end having a receiving portion that can receive a fastener along a longitudinal axis of the patch. The lattice may include an interior surface that has a distributed interface with protruding and recessed portions that can interact with an exterior surface of the fastener. The lattice may include an exterior surface that has protruding and recessed multiple points of contact configured to interact with an interior bone surface. The lattice can have a degree of stability that maintains a three-dimensional structure of the lattice and has a degree of flexibility, the degree of stability and flexibility allowing for the distributed interface of the interior surface to distribute applied pressure to the protruding and recessed multiple points of contact of the exterior surface.
In an aspect of an embodiment of the present invention, the plurality of intersecting fibers includes sets of a first plurality of monofilaments that runs in a first direction and a second plurality of monofilaments that runs in a direction intersecting the first plurality of monofilaments. For each set of the first and second plurality of monofilaments, there can be a substantially same arrangement of cross-section geometries at every other intersection along that set, the substantially same arrangement being different from an arrangement of cross-section geometries at remaining intersections along that set. The first plurality of monofilaments can be thinner in diameter than the second plurality of monofilaments, in an embodiment. The first plurality of monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. In an embodiment, the distal end has a distal tip with a first diameter, and the receiving portion has a second diameter that is greater than the first diameter.
In an embodiment, the intersecting fibers may follow a two-under/two-over configuration, where at each intersection, the second plurality of monofilaments either overlies both of the intersecting monofilaments or is overlain by both of the intersecting monofilaments and the second plurality of monofilaments overlies one of the intersecting filaments and is overlain by the other of the intersecting filaments. The intersecting fibers may outline interstices that allow for bone ingrowth, and the interstices formed by the intersecting fibers can include differently shaped and differently sized interstices. In a relaxed state, the intersecting fibers can extend around the lattice at an angle of about 45 degrees with respect to a parallel direction of the woven patch.
In an aspect of an embodiment, when the fastener applies pressure to the interior surface, the pressure is transmitted to protuberances on the exterior surface adjacent to the protuberance on the exterior surface that interior surface and exerting pressure on bone material.
According to another embodiment of the present invention, a method of applying a woven patch is provided. The method includes inserting or applying the woven patch into a bone hole or onto a bone surface. The method also include distributing pressure from a fastener being inserted into or applied onto the woven patch from an interior surface of the woven patch to an exterior surface of the woven patch for transmission of pressure to bone surface of the bone hole according to a function of bone density and according to a function of an interfacing surface shape of the fastener. The pressure from the fastener can change the spatial relationship of protuberances on the interior surface of the woven patch, and the pressure from the interior surface can change the spatial relationship of protuberances of the exterior surface of the woven patch. In an aspect of an embodiment, the fastener may be inserted into the woven patch after the woven patch has been inserted into the bone hole. In an aspect of an embodiment, the fastener may be inserted into the woven patch before the woven patch has been inserted into the bone hole. The pressure transmitted to the bone surface can be adapted to change shape of the bone surface of the bone hole.
In an aspect of an embodiment, the method can further include providing the woven patch. The distributing pressure step can include dynamic micro-loading of the woven patch based on differences in loading patterns of the woven patch and the interfacing surface shape of the fastener. In an embodiment, the method may further include elongating or constricting the woven patch for fitting the woven patch inside the bone hole, and expanding the woven patch upon entering the bone hole.
The applying the woven patch onto the bone surface can include surrounding a substantial portion of the bone with the woven patch, in one aspect of an embodiment. The applying the woven patch onto the bone surface may include applying a bone cement to the woven patch and the bone surface.
The method may further include providing a woven patch according to any of the embodiments discussed herein.
Method of Manufacturing Alternative Materials
According to an embodiment of the invention, a retention device for interfacing with a bone surface is provided. In one embodiment, the retention device is woven. However, in another embodiment, the retention device is non-woven.
According to an embodiment of the present invention, a method of manufacturing a retention device for treating infection, treating cancer, preventing infection or preventing disease is provided. The method includes providing a retention device for interfacing with a bone surface. The retention device may include a sleeve body having a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body can surround at least a portion of a fastener. Each of the plurality of protuberances can be formed by an intersection point of two or more of the plurality of filaments. The filaments can include an orthopedic biomaterial. The retention device can further include a proximal end that is proximal to the sleeve body and that can receive at least a portion of the fastener. The retention device may further include a distal end that is distal to the sleeve body. According to an embodiment, the method may further include extracting platelet-rich-plasma from a subject, and applying the platelet-rich-plasma to the retention device. The method further includes inserting the applied retention device into a bone hole having the bone surface. According to an embodiment, in a first state, the sleeve body has a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses. A thickness of each protuberance is measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
According to an embodiment, the method further includes inserting a fastener into the inserted retention device. In an aspect of an embodiment, the platelet-rich-plasma can be applied before inserting the retention device into the bone hole. The retention device can be a woven retention device where the filaments are interwoven.
In an aspect of an embodiment, the orthopedic biomaterial can include a hydrophilic material that attracts bone growth. The hydrophilic material can be a metal. In an aspect of an embodiment, the orthopedic biomaterial can include non-resorbable polymer fibers. The orthopedic biomaterial can include at least one of osteostimulative, antimicrobial, and plasma-rich-platelet (PRP) agents applied to the filaments. The non-resorbable polymer fibers can be roughened to wick one of osteostimulative, antimicrobial and plasma-rich-platelet agents. The orthopedic biomaterial can also include biologic fibers that are configured to absorb into a body, where the non-resorbable polymer fiber and the biologic fibers are interwoven. In an aspect of an embodiment, the orthopedic biomaterial includes a bioresorbable polymer that is configured to at least partially dissolve or be absorbed in the body.
In an embodiment, the interior surface of the retention device is tapped and allows for substantially uniformly expanding the sleeve body as the fastener is inserted.
In an embodiment of the present invention, the retention device is a non-woven retention device where the sleeve body includes at least one of silk, felt and collagen.
In an aspect of an embodiment, the interwoven filaments include a first plurality of monofilaments that runs in a first helical direction and a second plurality of monofilaments that runs in a direction intersecting the first plurality of monofilaments. For each set of the first and second plurality of monofilaments, there is a substantially same arrangement of cross-section geometries at every other intersection along that set, the substantially same arrangement being different from an arrangement of cross-section geometries at remaining intersections along that set.
In an embodiment, the method further includes a first plurality of multifilaments that runs in the first helical direction and a second plurality of multifilaments that runs in the second direction, the first plurality of monofilaments and the first plurality of multifilaments forming a first plurality of sets of filaments and the second plurality of monofilaments and the second plurality of multifilaments forming a second plurality of sets of filaments. Each of the first plurality of sets of filaments includes a first outer filament and a first inner filament, and each of the second plurality of sets of filaments includes a second outer filament and a second inner filament. The first plurality of monofilaments can be thinner in diameter than the second plurality of monofilaments. The first plurality of monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. The first plurality of monofilaments may have a diameter of 0.2 mm.
In an embodiment, the interwoven filaments follow a two-under/two-over configuration, where at each intersection, the second plurality of monofilaments either overlies both of the intersecting monofilaments or is overlain by both of the intersecting monofilaments and the second plurality of monofilaments overlies one of the intersecting filaments and is overlain by the other of the intersecting filaments. The first plurality of monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. The interwoven filaments can be arranged in a two-under/two-over configuration. The interwoven filaments can be arranged in a one-under/one-over configuration. The interwoven filaments can be arranged in a two-over/one-under configuration. The interwoven filaments can be arranged in a three-under/three-over configuration.
In an embodiment, the distal end has a distal tip with a first diameter, and the receiving portion has a second diameter that is greater than the first diameter. The plurality of filaments can include a plurality of flat multifilaments. The flat multifilaments may be roughened for wicking.
In an aspect of an embodiment, the filaments outline interstices that allow for bone ingrowth, and the interstices formed by the intersecting filaments include differently shaped and differently sized interstices. In an embodiment, the method further includes the fastener. The fastener can be a screw having a screw thread and the interior surface is configured to interact with the screw. The distal end of the device may be closed. In the first state, the interwoven filaments extend around the tubular lattice at an angle of about 45 degrees with respect to a longitudinal direction of the retention device. The distributed protuberances can arranged in a diamond-shaped pattern grid. The tubular lattice may have an outer radius spanning from a furthest outwardly extending protuberance in the radial direction on the exterior surface of the tubular lattice to a center point of the tubular lattice, the tubular lattice having an inner radius spanning from a furthest inwardly protruding protuberance in the axial direction on the interior surface of the tubular lattice to the center point of the tubular lattice, and the tubular lattice having an average radius that is an average between the outer radius and the inner radius. The outer radius of the tubular lattice can be greatest at the intersection point of two of the thick monofilaments. The tubular lattice may have an average diameter that is in a range of about 1.5 mm to 9.0 mm. The retention device may have a length in a range from about 30 mm to 40 mm. When the fastener applies pressure to the interior surface, the pressure is transmitted to protuberances on the exterior surface adjacent to the protuberance on the exterior surface that interior surface and exerting pressure on bone material.
In another embodiment of the present invention, a non-transitory computer-readable storage medium is provided having data thereon representing a three-dimensional model suitable for use in manufacturing a three-dimensional retention device for interfacing with a bone surface. The non-transitory computer-readable storage medium, when executed by at least one processor, can cause a computing system to use the data in forming the three-dimensional retention device to create a plurality of filaments having input regions that interlace with other filaments. The retention device may include a sleeve body including a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body can surround at least a portion of a fastener. Each of the plurality of protuberances is formed by an intersection point of two or more of the plurality of filaments, and the filaments can include an orthopedic biomaterial. The retention device may further include a proximal end that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener, and a distal end that is distal to the sleeve body. In a first state, the sleeve body has a plurality of combinations of filament cross-section geometries at the intersection points, the plurality of combinations of filament cross-section geometries forming a plurality of protuberance thicknesses, a thickness of each protuberance being measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
Alternative Materials
According to an embodiment of the invention, a retention device for interfacing with a bone surface is provided. In one embodiment, the retention device is woven. However, in another embodiment, the retention device is non-woven.
A retention device for interfacing with a bone surface can include a sleeve body having a plurality of filaments forming a substantially tubular lattice with a plurality of protuberances distributed on an interior surface and an exterior surface of the tubular lattice at a predetermined spatial relationship. The sleeve body can be configured to surround at least a portion of a fastener, and each of the plurality of protuberances can be formed by an intersection point of two or more of the plurality of filaments. The filaments can include an orthopedic biomaterial. The retention device can include a proximal end that is proximal to the sleeve body and that is configured to receive at least a portion of the fastener. The retention device can include a distal end that is distal to the sleeve body. In a first state, the sleeve body can have a plurality of combinations of filament cross-section geometries at the intersection points, and the plurality of combinations of filament cross-section geometries can form a plurality of protuberance thicknesses. A thickness of each protuberance can be measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener can be transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and according to a function of an interfacing surface shape of the fastener.
The retention device can be a woven retention device and the filaments can be interwoven. The orthopedic biomaterial can include a hydrophilic material that attracts bone growth. The hydrophilic material can be a metal. The interior surface of the retention device can be tapped and can allow for substantially uniformly expanding the sleeve body as the fastener is inserted. The orthopedic biomaterial can include non-resorbable polymer fibers. The orthopedic biomaterial can include at least one of osteostimulative, antimicrobial, and plasma-rich-platelet (PRP) agents applied to the filaments. The non-resorbable polymer fibers are roughened to wick one of osteostimulative, antimicrobial and plasma-rich-platelet agents. The orthopedic biomaterial can include biologic fibers that are configured to absorb into a body, and wherein the non-resorbable polymer fiber and the biologic fibers can be interwoven. The retention device can be a non-woven retention device and the sleeve body can include at least one of silk, felt and collagen.
The interwoven filaments can include a first plurality of monofilaments that runs in a first helical direction and a second plurality of monofilaments that runs in a direction intersecting the first plurality of monofilaments. For each set of the first and second plurality of monofilaments, there can be a substantially same arrangement of cross-section geometries at every other intersection along that set. The substantially same arrangement can be different from an arrangement of cross-section geometries at remaining intersections along that set.
The retention device can further include a first plurality of multifilaments that runs in the first helical direction and a second plurality of multifilaments that runs in the second direction. The first plurality of monofilaments and the first plurality of multifilaments can form a first plurality of sets of filaments and the second plurality of monofilaments and the second plurality of multifilaments can form a second plurality of sets of filaments. Each of the first plurality of sets of filaments can include a first outer filament and a first inner filament, and each of the second plurality of sets of filaments can include a second outer filament and a second inner filament.
The first plurality of monofilaments can be thinner in diameter than the second plurality of monofilaments.
The interwoven filaments can follow a two-under/two-over configuration, where at each intersection, the second plurality of monofilaments either overlies both of the intersecting monofilaments or is overlain by both of the intersecting monofilaments and the second plurality of monofilaments overlies one of the intersecting filaments and is overlain by the other of the intersecting filaments.
The first plurality of monofilaments can have a diameter in a range of about 0.1 mm-0.4 mm. The first plurality of monofilaments can have a diameter of 0.2 mm.
The interwoven filaments can be arranged in a two-under/two-over configuration. The interwoven filaments can be arranged in a one-under/one-over configuration. The interwoven filaments can be arranged in a three-under/three-over configuration.
The orthopedic biomaterial can include a bioresorbable polymer that is configured to at least partially dissolve or be absorbed in the body. The distal end can have a distal tip with a first diameter, and the receiving portion can have a second diameter that is greater than the first diameter.
The plurality of filaments can include a plurality of flat multifilaments. The flat multifilaments can be roughened for wicking.
The filaments can outline interstices that allow for bone ingrowth, and the interstices formed by the intersecting filaments can include differently shaped and differently sized interstices.
The fastener can be a screw having a screw thread and the interior surface is configured to interact with the screw.
The distal end of the retention device can be closed.
In the first state, the interwoven filaments can extend around the tubular lattice at an angle of about 45 degrees with respect to a longitudinal direction of the retention device.
The distributed protuberances can be arranged in a diamond-shaped pattern grid.
The tubular lattice can have an outer radius spanning from a furthest outwardly extending protuberance in the radial direction on the exterior surface of the tubular lattice to a center point of the tubular lattice. The tubular lattice can have an inner radius spanning from a furthest inwardly protruding protuberance in the axial direction on the interior surface of the tubular lattice to the center point of the tubular lattice. The tubular lattice can have an average radius that is an average between the outer radius and the inner radius. The outer radius of the tubular lattice can be greatest at the intersection point of two of the thick monofilaments.
The tubular lattice can have an average diameter that is in a range of about 1.5 mm to 9.0 mm. The retention device can have a length in a range from about 30 mm to 40 mm.
When the fastener applies pressure to the interior surface, the pressure can be transmitted to protuberances on the exterior surface adjacent to the protuberance on the exterior surface and exert pressure on bone material. The retention device can further include the fastener.
Additional features, advantages, and embodiments of the invention are set forth or apparent from consideration of the following detailed description, drawings and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.
In describing embodiments, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology and examples selected. A person skilled in the relevant art will recognize that other equivalent components can be employed and other methods developed without departing from the broad concepts of the current invention.
Although the foregoing description is directed to the preferred embodiments of the invention, it is noted that other variations and modifications will be apparent to those skilled in the art, and may be made without departing from the spirit or scope of the invention. Moreover, features described in connection with one embodiment of the invention may be used in conjunction with other embodiments, even if not explicitly stated above.
This application claims priority to U.S. Provisional Application No. 62/265,220, filed Dec. 9, 2015, U.S. Provisional Application No. 62/265,279, filed Dec. 9, 2015, U.S. Provisional Application No. 62/265,236, filed Dec. 9, 2015, U.S. Provisional Application No. 62/265,251, filed Dec. 9, 2015, U.S. Provisional Application No. 62/265,276, filed Dec. 9, 2015, and U.S. Provisional Application No. 62/265,275, filed Dec. 9, 2015, the contents of which are hereby incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 62265220 | Dec 2015 | US | |
| 62265236 | Dec 2015 | US | |
| 62265251 | Dec 2015 | US | |
| 62265275 | Dec 2015 | US | |
| 62265276 | Dec 2015 | US | |
| 62265279 | Dec 2015 | US |
