The embodiments disclosed herein relate to bone implants, and more particularly to combination photodynamic devices for bone repair and stabilization.
Bones form the skeleton of the body and allow the body to be supported against gravity and to move and function in the world. Bone fractures can occur, for example, from an outside force or from a controlled surgical cut (an osteotomy). A fracture's alignment is described as to whether the fracture fragments are displaced or in their normal anatomic position. In some instances, surgery may be required to re-align and stabilize the fractured bone. It is often difficult to properly position and stabilize fractured or weakened bones. It would be desirable to have an improved device for repairing and stabilizing a fractured or weakened bone.
Combination photodynamic devices for repair and stabilization of a fractured or a weakened bone are disclosed herein. In one aspect, there is a provided a combination photodynamic device that includes at least one load bearing member designed to reside in a cavity of a fractured or weakened bone, and at least one conformable member connected to the at least one load bearing member. The at least one load bearing member acts as an internal bone fixation and stabilization device. The at least one conformable member is configured to be expandable from a deflated state to an inflated state to anchor the at least one load bearing member inside the cavity.
In one embodiment, the at least one conformable member is expandable from a deflated state to an inflated state using an expansion fluid. In an embodiment, the at least one conformable member is a balloon. In an embodiment, the at least one conformable member is designed to transform the at least one load bearing member from a flexible state for delivery to or removal from the cavity of the bone to a rigid state for implantation within the cavity of the bone. In an embodiment, the at least one conformable member is detachably or removably attached to the at least one load bearing member.
In an embodiment, the at least one load bearing member has a threaded end so that the at least one load bearing member can be screwed into the bone. In an embodiment, the at least one load bearing member is an elongated rod or an intramedullary nail. In an embodiment, the at least one load bearing member is made of a flexible material. In an embodiment, the at least one load bearing member includes a plurality of nested tubes telescopically slidable relative to one another. In an embodiment, the at least one load bearing member has a compressible body that can be transformed from a flexible state to a rigid state by a compressive force. In an embodiment, the at least one load bearing member is transformable between a flexible state and a rigid state by radially expanding the at least one load bearing member using the conformable member placed inside the load bearing member. In an embodiment, the at least one load bearing member is as at least partially enclosed by the at least one conformable member. In an embodiment, the at least one load bearing member is adjacent to the at least one conformable member. In an embodiment, the at least one load bearing member is a flexible patterned tube or a flexible helical spring, and the at least one conformable member is configured to be inserted in the at least one load bearing member and expanded to transform the at least one load bearing member to a rigid state.
In an embodiment, the device includes one or more holes in the at least one load bearing member and/or at least one conformable member for receiving one or more fasteners to secure the device to the bone. In an embodiment, the device includes a cam structure attached to the at least one load bearing member and configured to act upon the at least one conformable member to increase pressure between the at least one load bearing member containing the cam structure, the at least one conformable member, and/or the weakened or fractured bone to stabilize the load bearing member in the cavity of the bone. In an embodiment, the at least one load bearing member includes one or more segments.
In one aspect, a combination photodynamic device kit includes: at least one expansion fluid; a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween; a conformable member releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member; and a load bearing member, wherein the load bearing member can be engaged with the conformable member. In an embodiment, the kit also includes a plurality of conformable members of different sizes or shapes.
In one aspect, a method for bone repair and stabilization includes: inserting a load bearing member into a cavity of a fractured or weakened bone; inserting one or more conformable members into the cavity; engaging the one or more conformable members with the load bearing member; and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the cavity and providing longitudinal and rotational stability to the load bearing member during the healing process. In an embodiment, the load bearing member is flexible when inserted into the cavity, and becomes rigid upon expanding the conformable member with an expansion fluid.
The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments.
While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.
Medical devices and methods for repairing and stabilizing a weakened or fractured bone are disclosed herein. As shown in
A combination photodynamic device may be used to treat a fractured or weakened bone. The combination photodynamic devices of the present disclosure are suitable to treat a fractured or weakened tibia, fibula, humerus, ulna, femur, radius, metatarsals, metacarpals, phalanx, phalanges, ribs, spine, vertebrae, clavicle, pelvis, wrist, mandible, and other bones and still be within the scope and spirit of the disclosed embodiments. In an embodiment, a combination photodynamic devices of the present disclosure is used to stabilize, reinforce or support a weakened bone. In an embodiment, a combination photodynamic devices of the present disclosure is used to stabilize a fractured bone in conjunction with anatomic reduction (i.e., proper reorientation of fractured elements to their original position, both relative to one another and relative to other adjacent anatomical features).
As used herein, the terms “fracture” or “fractured bone” refer to a partial or complete break in the continuity of a bone. The fracture can occur, for example, from an outside force or from a controlled surgical cut (osteotomy). A combination photodynamic implant can be used to treat any type of bone fracture, including, but not limited to, a displaced fracture, a non-displaced fracture, an open fracture, a closed fracture, a hairline fracture, a compound fracture, a simple fracture, a multi-fragment fracture, a comminuted fracture, an avulsion fracture, a buckle fracture, a compacted fracture, a stress fracture, a compression fracture, multiple fractures in a bone, spiral fracture, butterfly fracture, other fractures as described by AO Foundation coding, and other types of fractures.
As used herein, the term “weakened bone” refers to a bone with a propensity toward a fracture due to a decreased strength or stability due to a disease or trauma. Some bone diseases that weaken the bones include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bones are more susceptible to fracture, and treatment to prevent bone fractures may be desirable.
In an embodiment, the combination photodynamic implant may be used to stabilizing fractured or weakened load bearing bones including, but not limited to, the femur and tibia bones of the leg. The use of the combination implant, in an embodiment, allows for strength of the load bearing member to be imparted through the use of metal or structural plastics like those listed above and other suitable materials. In an embodiment, use of the combination implant allows for minimally invasive placement since the load bearing member can be a small diameter but filling the internal cavity can be accomplished with the conformable member(s). In an embodiment, the combination implant can provide the required stability with potentially significant load carrying capacity increase due to the use of particular metal load bearing and photodynamic conformable members.
In an embodiment, the load bearing member 115 is sufficiently designed for implantation into a bone cavity via a minimally invasive method. The load bearing member 115 may be flexible or rigid. In an embodiment, the load bearing member 115 is in a flexible state for delivery to a bone cavity and is transformed to a rigid state once inside the bone cavity. In an embodiment, the load bearing member 115 is transformable from a flexible state to a rigid state by the conformable member 170. The load bearing member 115 can comprise a single piece or multiple pieces.
The load bearing member 115 can be made from a variety of biocompatible materials including, but not limited to, metal, composite, plastic or amorphous materials, which include, but are not limited to, steel, stainless steel, cobalt chromium plated steel, titanium, nickel titanium alloy (nitinol), superelastic alloy, and polymethylmethacrylate (PMMA), poly-ether ether ketone (PEEK), composite materials of polymers and minerals, composite materials of polymers and glass or polymeric fibers, composite materials of metal, polymer, and minerals and any other engineering materials.
Referring to
In an embodiment, as shown in
In an embodiment, the conformable member 170 is a balloon expandable from a deflated state to an inflated state by the addition of at least one expansion fluid. Modification of expansion fluid infusion allows a user to adjust the size and shape of the conformable member 170 in its inflated state, as is described above. Because the shape and size of the conformable members 170 are easily configurable by the user, the conformable member 170 can be adjusted to achieve a conformal fit with the cavity into which the combination photodynamic implant 100 is implanted, thereby ensuring that the implanted combination photodynamic implant 100 is longitudinally and rotationally secured inside the bone cavity. In an embodiment, the conformable member 170 can be adjusted to conform to the internal diameter of the bone cavity into which the combination photodynamic implant 100 is implanted as well as the curvature of the bone cavity. In an embodiment, the conformable member 170 is adjusted to transform the load bearing member 115 from a flexible state to a rigid state. In an embodiment, the conformable member 170 is adjusted to facilitate fixation, stabilization, or both of the fractured or weakened bone into which it is inserted.
In an embodiment, the expansion fluid is a curable liquid, that is a liquid that can progress from a flowable form for delivery to the conformable member 170, such as, for example, through a catheter, to a non-flowable (e.g., cured) form for final use in vivo. A cure may refer to any chemical, physical, and/or mechanical transformation. In an embodiment, the expansion fluid is a light-sensitive liquid 165, which can be cured inside the conformable member 170 by exposing it to light energy, as is described in more detail below. The term “curable” may refer to uncured liquid, having the potential to be cured in vivo (as by catalysis or the application of a suitable energy source), as well as to a liquid in the process of curing (e.g., a composition formed at the time of delivery by the concurrent mixing of a plurality of composition components). Curing the curable expansion fluid inside the conformable member 170 affixes the conformable member 170 in an expanded shape to form a photodynamic implant. It should be understood that a photodynamic implant will have the size and shape substantially similar to a conformable member from which the photodynamic implant is formed. Although a combination photodynamic implant with the conformable member 170 containing a cured curable liquid can be removed from the bone cavity, to simplify the removal of a combination photodynamic implant, the conformable member 170 can be expanded with a fluid that remains flowable inside the conformable member 170 so that the conformable member 170 can be easily deflated and removed, if necessary, thereby facilitating the removal of the load bearing member. Suitable examples of non-curable fluids include, but are not limited to, air, water or buffer solution or any other fluid that is non-curable. It should be noted that in an embodiment, the conformable member 170 can be formed by a cured light sensitive liquid, without a balloon.
In an embodiment, the expansion fluid may be provided as a unit dose. As used herein, the term “unit dose” is intended to mean an effective amount of light sensitive liquid adequate for a single session. By way of a non-limiting example, a unit dose of a light sensitive liquid of the present disclosure for expanding the conformable member 170 may be defined as enough expansion fluid to expand the conformable member 170 to a desired shape and size. The desired shape and size of the conformable member 170 may vary somewhat from patient to patient. Thus, a user using a unit dose may have excess expansion fluid left over. It is desirable to provide sufficient amount of expansion fluid to accommodate even the above-average patient. In an embodiment, a unit dose of a expansion fluid of the present disclosure is contained within a container. In an embodiment, a unit dose of a expansion fluid of the present disclosure is contained in an ampoule. In an embodiment, the conformable member 170 is sufficiently shaped and sized to fit within a space or a gap in a fractured bone. In an embodiment, the expansion fluid can be delivered under low pressure via a standard syringe attached to the port.
The conformable member 170 may be provided with a shape demanded by, for example, the anatomy of the implantation site, characteristics of the load bearing member 115 or both. Suitable shapes include, but not limited to, round, flat, cylindrical, dog bone, barbell, tapered, oval, conical, spherical, square, rectangular, toroidal and combinations thereof. The conformable member 170 can be manufactured from a non-compliant (non-stretch/non-expansion) conformable material including, but not limited to urethane, polyethylene terephthalate (PET), nylon elastomer and other similar polymers. In an embodiment, the conformable member 170 is manufactured from a polyethylene terephthalate (PET). In an embodiment, the conformable member 170 is manufactured from a radiolucent material, which permit x-rays to pass through the conformable member 170. In an embodiment, the conformable member 170 is manufactured from a radiolucent polyethylene terephthalate (PET). In an embodiment, the conformable member 170 is manufactured from a conformable compliant material that is limited in dimensional change by embedded fibers. In an embodiment, at least a portion of the external surface of the conformable member 170 is substantially even and smooth.
In an embodiment, at least a portion of the external surface of the conformable member 170 includes at least one textured element such as a bump, a ridge, a rib, an indentation or any other shape. In an embodiment, at least a portion of the external surface of the conformable member 170 protrudes out to form a textured element. In an embodiment, at least a portion of the external surface of the conformable member 170 invaginates to form a textured element. In an embodiment, the textured element increases the friction and improves the grip and stability of the conformable member 170 after the conformable member 170 is inserted into the fracture location. In an embodiment, the textured element results in increased interdigitation of bone-device interface as compared to an conformable member without textured elements. In an embodiment, the textured element can be convex in shape. In an embodiment, the textured element can be concave in shape. In an embodiment, the textured element can be circumferential around the width of the conformable member 170, either completely or partially.
In general, bone graft or bone graft substitute can be used in conjunction with an conformable member 170 of the present disclosure. In an embodiment, the bone graft is an allogeneic bone graft. In an embodiment, the bone graft is an autologous bone graft. In an embodiment, the bone graft substitute is a hydroxyapatite bone substitute. In an embodiment, a bone graft or bone graft substitute is used to fill in any gaps that may exist, for example, between the external surface of the conformable member 170 and the surfaces of the bone fragments. In an embodiment, a bone graft or bone graft substitute is used to fill any gaps that may exist, for example, between the textured element of the conformable member 170 and the surfaces of the bone fragments.
In general, the conformable member 170 can include an external surface that may be coated with materials including, but not limited to, drugs (for example, antibiotics), proteins (for example, growth factors) or other natural or synthetic additives (for example, radiopaque or ultrasonically active materials). For example, after a minimally invasive surgical procedure an infection may develop in a patient, requiring the patient to undergo antibiotic treatment. An antibiotic drug may be added to the external surface of the conformable member 170 to prevent or combat a possible infection. Proteins, such as, for example, bone morphogenic protein or other growth factors have been shown to induce the formation of cartilage and bone. A growth factor may be added to the external surface of the conformable member 170 to help induce the formation of new bone. Due to the lack of thermal egress of the light-sensitive liquid 165 in the conformable member 170, the effectiveness and stability of the coating is maintained.
In general, the conformable member 170 typically does not have any valves. One benefit of having no valves is that the conformable member 170 may be expanded or reduced in size as many times as necessary to assist in the fracture reduction and placement. Another benefit of the conformable member 170 having no valves is the efficacy and safety of the system 100. Since there is no communication passage of light-sensitive liquid 165 to the body there cannot be any leakage of liquid 165 because all the liquid 165 is contained within the conformable member 170. In an embodiment, a permanent seal is created between the conformable member 170 and the delivery catheter 150 that is both hardened and affixed prior to the delivery catheter 150 being removed.
In an embodiment, abrasively treating the external surface of the conformable member 170, for example, by chemical etching or air propelled abrasive media, improves the connection and adhesion between the external surface of the conformable member 170 and a bone surface. The surfacing significantly increases the amount of surface area that comes in contact with the bone which can result in a stronger grip.
In the embodiment shown in
As illustrated in
In an embodiment, a contrast material may be added to the light-sensitive liquid 165 without significantly increasing the viscosity. Contrast materials include, but are not limited to, barium sulfate, tantalum, or any other suitable contrast materials. The light-sensitive liquid 165 can be introduced into the proximal end of the flexible delivery catheter 150 and passes within the inner void 152 of the flexible delivery catheter 150 up into an inner cavity 172 of the conformable member 170 to change a thickness of the conformable member 170 without changing a width or depth of the conformable member 170. In an embodiment, the light-sensitive liquid 165 is delivered under low pressure via the syringe 160 attached to the port. The light-sensitive liquid 165 can be aspirated and reinfused as necessary, allowing for thickness adjustments to the conformable member 170 prior to activating the light source 110 and converting the liquid monomer 165 into a hard polymer.
As illustrated in
Light-conducting fibers use a construction of concentric layers for optical and mechanical advantages. The light-conducting fiber can be made from any material including, but not limited to, glass, silicon, silica glass, quartz, sapphire, plastic, combinations of materials, or any other material, and may have any diameter. In an embodiment, the light-conducting fiber is made from a polymethyl methacrylate core with a transparent polymer cladding. The light-conducting fiber can have a diameter between approximately 0.75 mm and approximately 2.0 mm. In some embodiments, the light-conducting fiber can have a diameter of about 0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mm or greater than about 2 mm. In an embodiment, the light-conducting fiber may be made from a polymethyl methacrylate core with a transparent polymer cladding. It should be appreciated that the above-described characteristics and properties of the light-conducting fibers are exemplary and not all embodiments of the present disclosure are intended to be limited in these respects. Light energy from a visible emitting light source can be transmitted by the light-conducting fiber. In an embodiment, visible light having a wavelength spectrum of between about 380 nm to about 780 nm, between about 400 nm to about 600 nm, between about 420 nm to about 500 nm, between about 430 nm to about 440 nm, is used to cure the light-sensitive liquid.
The most basic function of a fiber is to guide light, i.e., to keep light concentrated over longer propagation distances—despite the natural tendency of light beams to diverge, and possibly even under conditions of strong bending. In the simple case of a step-index fiber, this guidance is achieved by creating a region with increased refractive index around the fiber axis, called the fiber core, which is surrounded by the cladding. The cladding may be protected with a polymer coating. Light is kept in the “core” of the light-conducting fiber by total internal reflection. Cladding keeps light traveling down the length of the fiber to a destination. In some instances, it is desirable to conduct electromagnetic waves along a single guide and extract light along a given length of the guide's distal end rather than only at the guide's terminating face.
In some embodiments of the present disclosure, at least a portion of a length of an light-conducting fiber is modified, e.g., by removing the cladding, in order to alter the profile of light exuded from the light-conducting fiber. The term “profile of light” refers to, without limitation, direction, propagation, amount, intensity, angle of incidence, uniformity, distribution of light and combinations thereof. In an embodiment, the light-conducting fiber emits light radially in a uniform manner, such as, for example, with uniform intensity, along a length of the light-conducting fiber in addition to or instead of emitting light from its terminal end/tip. To that end, all or part of the cladding along the length of the light-conducting fiber may be removed. It should be noted that the term “removing cladding” includes taking away the cladding entirely to expose the light-conducting fiber as well as reducing the thickness of the cladding. In addition, the term “removing cladding” includes forming an opening, such as a cut, a notch, or a hole, through the cladding. In an embodiment, removing all or part of the cladding may alter the propagation of light along the light-conducting fiber. In another embodiment, removing all or part of the cladding may alter the direction and angle of incidence of light exuded from the light-conducting fiber.
In an embodiment, the cladding is removed by making a plurality of cuts in the cladding to expose the core of the light-conducting fiber. In an embodiment, the cladding is removed in a spiral fashion. In an embodiment, the cladding is removed in such a way that a similar amount of light is exuded along the length of the modified section of the light-conducting fiber. In another embodiment, the cladding is removed in such a way that the amount of light exuded along the length of the modified section of the light-conducting fiber changes from the distal end to the proximal end of the modified section. In another embodiment, the cladding is removed in such a way that the amount of light exuded along the modified section of the light-conducting fiber decreases from the distal end of the modified section of the light-conducting fiber toward the proximal end thereof. In an embodiment, to alter the profile of the light exuded from the modified section, the cuts in the cladding are located along the length of the fiber in a spiral. In an embodiment, the pitch or spacing between the cuts is varied along the length of the modified section of the light-conducting fiber. In an embodiment, the spacing between the cuts increases from the proximal end of the modified section of the light-conducting fiber 165 to the distal end thereof such that the amount of light exuded from the modified section of the light-conducting fiber progressively increases toward the distal end of the modified section of the light-conducting fiber.
Once the light-sensitive liquid 165 is cured within the conformable member 170 to form a photodynamic implant, the light conducting fiber 165 is withdrawn from the system 200 and the conformable member 170 is separated from the delivery catheter 150. In an embodiment, a separation area is located at the junction between the distal end of the conformable member 170 and the delivery catheter 150 to facilitate the release of the photodynamic implant 510 from the delivery catheter 150. The separation area ensures that there are no leaks of reinforcing material from the elongated shaft of the delivery catheter and/or the conformable member 170. The separation area seals the photodynamic implant and removes the elongated shaft of the delivery catheter by making a break at a known or predetermined site (e.g., a separation area). The separation area may be various lengths and up to about an inch long. The separation area may also a stress concentrator, such as a notch, groove, channel or similar structure that concentrates stress in the separation area. The stress concentrator is designed to ensure that the conformable member 170 is separated from the delivery catheter 150 at the separation area. When torque (twisting) is applied to the delivery catheter 150, the conformable member 170 separates from the shaft of the delivery catheter 150. The twisting creates a sufficient shear to break the residual reinforcing material and create a clean separation of the conformable member 170/shaft interface. It should of course be understood that the conformable member 170 may be separated from the delivery catheter 150 by any other means known and used in the art.
Referring to
In an embodiment, as shown in
In reference to
In some embodiments of a combination photodynamic implant, the load bearing member is transformable between a flexible state and a rigid state by radially expanding the load bearing member 115 by the conformable member 170 placed inside the load bearing member 115. Various suitable designs for the load bearing member 115 of the combination photodynamic implant 600 are disclosed, for example, in U.S. Pat. No. 7,909,825. In an embodiment, the conformable member 170 is inserted inside the load bearing member and is expanded to transform the load bearing member 115 from a flexible state to a rigid state. In an embodiment, the design of the load bearing member 115 is such that a light-sensitive liquid can be contained inside the load bearing member 115 without a conformable member 170, such that the light-sensitive liquid can be infused directly into the load bearing member 115 to expand the load bearing member 115.
As shown in
As shown in
In an embodiment, as shown in
In an embodiment, as shown in
In an embodiment, the load bearing member of the combination photodynamic implant 600 can have a diameter similar to the inner diameter of the bone cavity into which the implant 600 is implanted such that the load bearing member undergoes no, or only a minimal amount of, radial expansion by the conformable member.
In reference to
In an embodiment, the load bearing member is transformable between a flexible state and a rigid state. The load bearing member may have any design as described in regard to combination photodynamic implants 500 and 600. Upon delivering the combination photodynamic implant 700 to a bone cavity, the conformable member 170 can be expanded, thereby expanding and stiffening the load bearing member 620 and, at the same time, locking the load bearing member 620 in place within the bone cavity. In an embodiment, the load bearing member may be rigid, such as described above in reference to combination photodynamic implant 400. Curing a light-sensitive liquid inside the conformable member can further stiffen the load bearing member and assist the load bearing member in stabilizing the bone.
In an embodiment, use of multiple conformable members 170 facilitates both tightening to slightly increase radial tension of conformable member 170 structures on cortical wall, as well as reversibility to decrease tension to simplify the removal of the combination photodynamic implant 800. In an embodiment, the one or more conformable members 170 may be filled with a non-curable fluid, that is a fluid that will remain flowable (i.e. non-cured) inside the one or more conformable members 170, such as air or water or buffer solution, to ensure the ease of removal of the one or more conformable members 170.
In an embodiment, the conformable members 170 that at least partially enclose or encircle the load bearing member, as shown in
Referring to
In another embodiment, as shown in
The access hole 1010 extends through a hard compact outer layer 1020 of the bone into the relatively porous inner or cancellous tissue 1025. For bones with marrow, the medullary material should be cleared from the medullary cavity prior to insertion of the inventive device. Marrow is found mainly in the flat bones such as hip bone, breast bone, skull, ribs, vertebrae and shoulder blades, and in the cancellous material at the proximal ends of the long bones like the femur and humerus. Once the medullary cavity is reached, the medullary material including air, blood, fluids, fat, marrow, tissue and bone debris should be removed to form a void. The void is defined as a hollowed out space, wherein a first position defines the most distal edge of the void with relation to the penetration point on the bone, and a second position defines the most proximal edge of the void with relation to the penetration site on the bone. The bone may be hollowed out sufficiently to have the medullary material of the medullary cavity up to the cortical bone removed. Any suitable method for removing the medullary material may be used. Suitable methods include, but are not limited to, those described in U.S. Pat. No. 4,294,251 entitled “Method of Suction Lavage,” U.S. Pat. No. 5,554,111 entitled “Bone Cleaning and Drying system,” U.S. Pat. No. 5,707,374 entitled “Apparatus for Preparing the Medullary Cavity,” U.S. Pat. No. 6,478,751 entitled “Bone Marrow Aspiration Needle,” and U.S. Pat. No. 6,358,252 entitled “Apparatus for Extracting Bone Marrow.”
As shown in
Next, as shown in
Once the conformable member 170 and the load bearing member 115 are in the desired position, the guidewire 1028 may be removed. The location of the conformable member 170 and the load bearing member 115 is determined using at least one radiopaque marker 1030 which may be detectable from the outside or the inside of the bone 1002. Next, the conformable member 170 is expanded by adding the expansion fluid to the conformable member 170 through the inner void of the delivery catheter 150, as shown in
In the embodiment where a light-sensitive liquid is used to expand the conformable member 170, a delivery system which contains a light-sensitive liquid is attached to the port of the delivery catheter 150 in communication with the inner void of the delivery catheter 150. The light-sensitive liquid is then infused through the inner void in the delivery catheter 150 into the conformable member 170. This addition of the light-sensitive liquid within the conformable member 170 causes the conformable member 170 to expand, as shown in
Referring to
In one aspect, a combination photodynamic device includes at least one load bearing member designed to reside in a cavity of a fractured or weakened bone, and at least one conformable member connected to the at least one load bearing member. The at least one load bearing member acts as an internal bone fixation and stabilization device. The at least one conformable member is configured to be expandable from a deflated state to an inflated state to anchor the at least one load bearing member inside the cavity.
In an embodiment, a combination photodynamic device of the present disclosure includes a load bearing member and one or more conformable members associated with the load bearing member, the conformable member expandable from a deflated state to an inflated state with an expansion fluid. The load bearing member is designed to reside inside of a cavity within a bone and act as internal bone fixation and stabilization device, while the conformable member is designed to anchor the load bearing member inside the intramedullary cavity to provide longitudinal and rotational stability to the load bearing member. In an embodiment, expanding the conformable member from a deflated state to an expanded state locks the load bearing member in place within a bone cavity into which its implanted as well as transforms the load bearing member from a flexible state to a rigid state.
In one aspect, a method for bone repair and stabilization includes: inserting a load bearing member into a cavity of a fractured or weakened bone; inserting one or more conformable members into the cavity; engaging the one or more conformable members with the load bearing member; and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the cavity and providing longitudinal and rotational stability to the load bearing member during the healing process.
In an embodiment, a method for bone repair and stabilization that includes inserting a load bearing member into a cavity of a fractured or weakened bone, inserting one or more conformable members into the cavity, associating the one or more conformable members with the load bearing member, and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the intramedullary cavity, providing longitudinal and rotational stability to the load bearing member during the healing process, transforming the load bearing member from a flexible state to a rigid state, contributing to fixating and stabilizing a fractured or a weakened bone, providing longitudinal and rotational stability to a fractured or a weakened bone during the healing process or combinations thereof.
In one aspect, a combination photodynamic device kit includes: at least one expansion fluid; a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween; a conformable member releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member; and a load bearing member, wherein the load bearing member can be engaged with the conformable member.
In an embodiment, there is provided a combination photodynamic device kit that includes a unit dose of at least one expansion fluid, a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein a conformable member is releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member, and a load bearing member, wherein the load bearing member can be associated with the conformable member. In an embodiment, the kit includes a plurality of conformable members of different sizes or shapes. In an embodiment, the kit includes a light source.
All patents, patent applications, and published references cited herein are hereby incorporated by reference in their entirety. It will be appreciated that several of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or application. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/509,314, filed on Jul. 19, 2011, U.S. Provisional Patent Application No. 61/509,391, filed on Jul. 19, 2011, and U.S. Provisional Patent Application No. 61/509,459, filed on Jul. 19, 2011, the entirety of these applications are hereby incorporated herein by reference.
Number | Date | Country | |
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61509314 | Jul 2011 | US | |
61509391 | Jul 2011 | US | |
61509459 | Jul 2011 | US |