WO2009105535A1 - Dispositif ostéointégré transcutané pour prothèses - Google Patents
Dispositif ostéointégré transcutané pour prothèses Download PDFInfo
- Publication number
- WO2009105535A1 WO2009105535A1 PCT/US2009/034512 US2009034512W WO2009105535A1 WO 2009105535 A1 WO2009105535 A1 WO 2009105535A1 US 2009034512 W US2009034512 W US 2009034512W WO 2009105535 A1 WO2009105535 A1 WO 2009105535A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bone
- sleeve portion
- transcutaneous
- flange portion
- sleeve
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2814—Bone stump caps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2/30749—Fixation appliances for connecting prostheses to the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/54—Artificial arms or hands or parts thereof
- A61F2/58—Elbows; Wrists ; Other joints; Hands
- A61F2/583—Hands; Wrist joints
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/60—Artificial legs or feet or parts thereof
- A61F2/66—Feet; Ankle joints
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30433—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00958—Coating or prosthesis-covering structure made of bone or of bony tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
- A61F2310/00982—Coating made of collagen
Definitions
- Various embodiments of the present invention relate to devices and methods for securing a prosthetic device to an anatomical structure and, in particular, to a transcutaneous osseointegrated device configured to be fixated to an anatomical structure and coupled to a prosthetic device.
- External prosthesis have been used to improve mobility and function of humans and animals with missing extremities. While external prosthesis may be used, they have several limitations that complicate their use and limit their benefits. For example, external prosthesis may only be fitted on limbs with relatively long stumps, place pressure on soft tissue, have a suboptimal transfer of forces during locomotion resulting from forces traveling through soft tissue, and have relatively high wear rates.
- limb prostheses particularly weight-bearing prosthetic devices (such as artificial legs and/or feet)
- fixation of limb prostheses to a bony structure typically requires the use of a transcutaneous adapter extending from the bone to an externally-located prosthetic device via an opening in the skin of the residual limb.
- Such openings may allow infection to develop in the residual limb.
- the onset of infection in such conventional systems may result in the need for the complete removal and/or replacement of the transcutaneous member.
- transcutaneous adapter that is integrated with a bone-fixation portion (such as an implantable stem and/or bone plate attached to the bone via screws)
- inpatient surgical procedures may be required to replace the entire system in an attempt to treat the infection.
- many conventional prosthetic systems provide a single, large- diameter, transcutaneous adapter that is tasked with supporting the majority of the force exerted on the suspension system as the user ambulates.
- the single transcutaneous adapter may, in some cases, be prone to failure and/or premature wear, particularly at points where the bone fixation portion is not adequately integrated with the bone.
- transcutaneous device that is configured to reduce the incidence of infection.
- transcutaneous device may be sufficiently integrated in the bone of the limb so as to provide adequate fixation.
- transcutaneous device that is adaptable to a variety of limbs.
- inventions of the present invention which, in one embodiment, provides a transcutaneous osseointegrated device for fixation of prosthetic devices.
- the device is configured to reduce the incidence of infection and promote long-term fixation with the limb.
- the device may be used for receiving various prostheses, such as a foot or hand and may be various sizes and configurations for accommodating various sized patients.
- the device includes a sleeve portion configured to receive at least a portion of a bone and be fixated to the bone and a flange portion adjacent to the sleeve portion and configured to abut the end of the limb (e.g., the bone, surrounding skin, tissue, muscles, tendons, and/or fascia).
- the flange portion has a first side facing the sleeve portion and an opposing second side.
- the device further includes a post portion extending from the second surface and configured to be coupled with a prosthetic device.
- the sleeve portion may include an opening and a thin wall such that the bone is configured to be received within the opening, and such that the thin wall provides an interface between both its interior surface and the bone and between its outer surface and the surrounding tissue.
- the flange portion may extend radially outward from the sleeve portion and the first side of the flange portion may be configured to cup the end of the bone and surrounding tissue.
- the inner surface of the sleeve may be textured, coated, and/or porous to facilitate bone fixation.
- the outer surface of the sleeve may also be textured, coated, and/or porous to promote tissue in-growth and/or on-growth.
- at least a portion of the first side of the flange may be textured, coated, and/or porous to promote in-growth and/or on-growth with the tissue.
- the sleeve portion may include a plurality of holes for receiving respective fasteners.
- the heads of the fasteners may be configured to engage the sleeve portion and lock in place using a Morse taper or thin thread.
- the fasteners may be configured to extend through the sleeve portion and into the central canal of the bone, such as for larger bones.
- the post portion may be configured for threaded engagement with the prosthetic device.
- the post portion may include a threaded surface
- the device may further include a threaded nut having a hole configured to receive a stem of the prosthetic device and engage the threaded surface of the post portion.
- the post portion may also include a tapered hole that is configured to mate with a correspondingly tapered end of the stem.
- the device may be integrally defined from a single piece of material, such as a biocompatible metal material.
- An additional embodiment provides a method for manufacturing a transcutaneous osseointegrated device for fixation of a prosthetic device to a bone and surrounding tissue of a limb.
- the method includes integrally forming a transcutaneous osseointegrated device comprising a sleeve portion, a flange portion, and a post portion using an additive manufacturing process (e.g., an energy-beam additive manufacturing process).
- the method may include imaging the limb and creating a computer model of the limb based on the imaging, wherein integrally forming comprises automatically forming the transcutaneous osseointegrated device in accordance with the computer model.
- an embodiment of the present invention provides a method for fixating a prosthetic device to a bone and surrounding tissue of a limb with a transcutaneous osseointegrated device.
- the method includes providing a transcutaneous osseointegrated device comprising a sleeve portion, a flange portion, and a post portion, positioning at least a portion of the bone within the sleeve portion such that the flange portion abuts the bone and surrounding tissue, and coupling the post portion to the prosthetic device.
- FIG. 1 is a perspective view of a transcutaneous osseointegrated device according to one embodiment of the present invention
- FIG. 2 is a perspective view of a transcutaneous osseointegrated device according to another embodiment of the present invention
- FIG. 3 is an end view of the transcutaneous osseointegrated device shown in FIG.
- FIG. 4 is cross-sectional view of the transcutaneous osseointegrated device shown in FIG. 2;
- FIG. 5 is a partial cross-sectional view of a transcutaneous osseointegrated device with a stem coupled thereto according to one embodiment of the present invention
- FIG. 6 is a partial perspective view of a transcutaneous osseointegrated device coupled to a prosthetic device according to one embodiment of the present invention
- FIG. 7 is an exploded perspective view of the transcutaneous osseointegrated device and prosthetic device shown in FIG. 6;
- FIG. 8 is a cross-sectional view of a transcutaneous osseointegrated device according to an additional embodiment of the present invention.
- FIG. 9 is a perspective view of a transcutaneous osseointegrated device installed within a tibia of a feline according to an additional embodiment of the present invention.
- FIG. 10 is a perspective view of the transcutaneous osseointegrated device of FIG.
- embodiments of the present invention generally provide a transcutaneous osseointegrated device 10 for fixation of a prosthetic device to a bone and surrounding tissue of a limb.
- the device includes a sleeve portion 12, a flange portion 14, and a post portion 16.
- the sleeve portion 12 is configured to receive at least a portion of the bone and facilitate fixation with the bone.
- the flange portion 14 extends from the sleeve portion 12 and is configured to abut the bone and surrounding tissue such as various soft tissue (e.g., the skin, subcutaneous tissue, deep tissue, muscles, tendons, and/or fascia) of the limb, while the post portion 16 extends from the flange portion and is configured to be coupled to the prosthetic device 42 (see FIGS. 6-7).
- the device 10 is adaptable to a variety of bones, such as the phalanx, metacarpals, humerus, metatarsals, tarsals, tibia, and femur that are configured to receive various prosthetic devices, such as a digit, foot, or hand and may be various sizes and configurations for accommodating various sized patients.
- the sleeve portion 12 may have a generally cylindrical shape or as shown in FIGS. 2 and 3, the sleeve portion may be slightly tapered between its ends.
- the sleeve portion 12 may have a slightly smaller diameter opening than at its opposite end adjacent to the flange portion 14.
- FIG. 3 shows that the sleeve portion may have various non- circular or irregular configurations, which may be customized for a particular patient and/or bone.
- FIG. 4 illustrates that the sleeve portion 12 has an opening 18 extending between its ends that defines a thin wall 20.
- the end of the bone is configured to be at least partially received within the opening 18 such that the thin wall 20 provides an interface between both its inner surface 24 and the bone and between its outer surface 26 and the surrounding skin, tissue, muscles, tendons, and/or fascia.
- the thin wall 20 may prevent the migration of bacteria from the outer surface of the thin wall towards the bone.
- the sleeve portion 12 may provide sufficient strength and stiffness for load bearing, and the length and stiffness of the sleeve portion may be adjusted for different sized patients and for the amount of fixation desired.
- the sleeve portion 12 may have a textured, coated, and/or porous surface(s) to facilitate bone fixation.
- FIGS. 1, 2, and 4 illustrate that a portion of the outer surface 26 may be a textured/coated/porous surface 22 for facilitating long term fixation between the skin and subcutaneous tissue with the sleeve portion 12.
- FIG. 4 shows that the inner surface 24 of the thin wall 20 may also be textured/coated/porous.
- the textured surface could be rough, raised, or other uneven surface.
- various synthetic or biological coatings or surface treatments may be used to encourage tissue ingrowth into the inner 24 and outer 26 surfaces, such as that disclosed in U.S. Patent No.
- the inner 24 and outer 26 surfaces could employ any one of the following coatings that are useful for their osteoinductive or osteoconductive ability: demineralized bone matrix (DBM), bone morphogenetic proteins (BMPs), transforming growth factors (TGFs), fibroblast growth factors (FGFs), insulin- like growth factors (IGFs), platelet-derived growth factors (PDGFs), epidermal growth factors (EGFs), vascular endothelial growth factors (VEGFs), vascular permeability factors (VPFs), cell adhesion molecules (CAMs), calcium aluminate, hydroxyapatite, coralline hydroxyapatite, alumina, zirconia, aluminum silicates, calcium phosphate, tricalcium phosphate, calcium sulfate, polypropylene fumarate, bioactive glass, porous titanium, porous nickel-titanium alloy, porous tantalum, sintered cobalt-chrome beads, ceramic
- DBM demineralized bone matrix
- BMPs bone morphogenetic proteins
- the coatings may include any medicament useful in facilitating the healing and regenerative process such as, for example, antivirals, antibacterials, antiinflammatories, immunosuppressants, analgesics, anticoagulants, and wound healing promotion agents.
- a bioactive coating may be employed where a patient's cells or stem cells are seeded onto the surface and cultured before implantation to provide a living interface.
- the outer surface 26 is shown as being textured/coated/porous, it is understood that various portions, or the entire outer surface, may be textured/coated/porous.
- the entire inner surface 24 is shown as being textured/coated/porous, only a portion of the inner surface may be textured/coated/porous depending on the amount of fixation desired.
- the sleeve portion 12 may also include one or more holes configured to receive and guide one or more fasteners 28 into the bone for ensuring initial stability with the bone.
- FIGS. 1, 2, and 4 illustrate that the sleeve portion 12 may be configured to receive a plurality of fasteners 28.
- FIG. 1 shows that the sleeve portion 12 includes a pair of fasteners 28, while FIG. 2 shows that the sleeve portion may include four fasteners, although any number of fasteners could be used in order to achieve a particular amount of fixation.
- Each fastener 28 may include a respective head 30 that is configured to engage the sleeve portion 12 and lock in place, such as using a Morse taper or thin thread.
- fasteners 28 may be employed, such as fasteners having a slotted, cruciform, hexagonal, or star head 30 configuration.
- the fasteners may be configured to extend through the bone and out of the opposite side of the sleeve portion as shown in FIGS. 1 and 2, or the fasteners may be configured to extend into and engage a central canal of the bone.
- the fasteners 28 may extend through an upper portion of the sleeve portion 12 as shown in FIGS. 1 and 2 so as to be spaced away from the skin ingrowth surfaces to minimize the likelihood of bacterial infection in the bone.
- the location and/or number of fasteners 28 may be modified for a particular patient or amount of fixation desired.
- FIG. 8 shows that the sleeve portion 12 may include a rod member 58 extending from the flange portion 14.
- the rod member 58 may extend at least partially along the length of the sleeve portion 12 and be configured to engage the end of a bone 59.
- the rod member 58 may be capable of being inserted within the medullary canal of the bone for additional long-term fixation.
- the rod 58 may be various lengths, including extending partially along the length of the sleeve portion 12 or beyond the length of the sleeve portion as shown in FIG. 8.
- the inner and/or outer surfaces of the rod member 58 may be textured, coated, and/or porous for facilitating bone fixation.
- the size and configuration of the rod member 58 may be modified for a particular bone and/or patient.
- the flange portion 14 may extend radially outward from the sleeve portion 12 and post portion 16, as depicted in FIGS. 1-7.
- the flange portion 14 may be configured to abut the bone and surrounding tissue (e.g., skin, subcutaneous tissue, deep tissue, muscles, tendons, and/or fascia).
- the flange portion 14 may be configured to cup the end of the limb for not only protecting the skin, tissue, muscles, tendons, and/or fascia, but also facilitating fixation with the skin, tissue, muscles, tendons, and/or fascia.
- the outer edge 32 may be flat as shown in FIGS. 1 and 5, or the flange 14 may be recessed such that the outer edge is curved so as to extend slightly upwards as shown in FIGS.
- the curved outer edge 32 may be configured to extend around the surrounding skin, tissue, muscles, tendons, and/or fascia.
- a portion of the inner surface 34 of the flange portion 14 may be textured/coated/porous surface for facilitating long term fixation with the skin and subcutaneous tissue. As described above, various coatings or surface treatments may be used to encourage tissue ingrowth, which may be provided on the inner surface 34 of the flange portion 14.
- FIG. 1 shows that the flange portion 14 may include holes 35 for receiving suture that may be used to secure the subcutaneous tissue and skin thereto.
- the flange portion 14 may include a plurality of arched hooks 36 for anchoring the deep soft tissue with suture, as well as a plurality of inner holes 38 for anchoring the subcutaneous tissue and outer holes 40 for anchoring the skin.
- suture may be looped around the hooks 36 or through the holes 38, 40 and through the skin and/or tissue to anchor the skin and/or tissue to the flange portion 14.
- the hooks 36 and holes 38, 40 may be arranged about the circumference of the flange portion 14 or in any other desired configuration to fixate the skin and subcutaneous tissue to the flange portion.
- the post portion 18 extends from the flange portion 14 opposite the sleeve portion 12 and is configured to mate with and provide a modular fixation to a prosthetic device 42.
- the post portion 16 is of a sufficient length to facilitate alignment and mechanical engagement with a stem 44 of the prosthetic device 42.
- the post portion 16 may be generally cylindrical and include an opening 46 for coupling with the stem 44 of the prosthetic device 42 (shown in FIGS. 6-7).
- the opening 46 is tapered and capable of receiving a correspondingly tapered end 48 of the stem 44.
- the post portion 16 may include a threaded portion 50 configured to engage threads 52 defined within an opening 54 of a self-locking nut 56.
- the self-locking nut 56 is configured to slide over the stem 44 and thread onto the threaded portion 50 of the post portion 16 such that the tapered end 48 is positively secured within the tapered opening 46.
- the opening 46 may be different sizes and configurations for mating with a variety of stems 44.
- the opening may be circular in cross section and configured to receive a cylindrical stem and secured therein with a fastener.
- the opening of the post portion 16 could include threads configured to engage a threaded stem.
- the size and configuration of the post portion 18 may be modified for particular bones and/or patients.
- the device 10 may comprise a variety of biocompatible metallic, composite, and/or polymeric materials that may include, for example, stainless steel, titanium, hydroxyapatite, fiber-reinforced polymer composites (e.g., carbon fiber composites), and combinations of such materials.
- biocompatible metallic, composite, and/or polymeric materials may include, for example, stainless steel, titanium, hydroxyapatite, fiber-reinforced polymer composites (e.g., carbon fiber composites), and combinations of such materials.
- the device 10 may be customized for a particular patient by imaging the patient's limb in order to create a computer model of the limb.
- a computed tomography (CT) scan of the patient's limb could be made and used to create a computer model of the limb such as with computer-aided design or other software known to those of ordinary skill in the art.
- a three-dimensional model of the limb including the patient's bone and skin may be created, and the model may be used in conjunction with an additive manufacturing process, such as an energy-beam additive manufacturing process, that is capable of being programmed to automatically form the device 10.
- an energy beam laser or electron beam
- an electron beam melting (EBM) process may be used to selectively melt metal powder one layer at the time.
- a three-dimensional computer model may be "sliced" into thin cross sections, and the beam may be controlled to follow the contours and fill in the areas to be solid.
- EBM electron beam melting
- the following list of references describes various additive manufacturing techniques that may be used to form the device 10 and are hereby incorporated by reference in their entirety herein: Cansizoglu O., Harrysson O. L. A., Cormier D. R., West II H. A., Mahale T., 2008, Properties of Ti-6A1-4V Non-stochastic Lattice Structures Fabricated Via Electron Beam Melting, Materials Science & Engineering A, 492, pp. 468-474; Schmitt, Stephen,
- the device 10 may be integrally formed with one step using an additive manufacturing process, which includes forming various textured surfaces for promoting tissue and bone ingrowth. Various machining or polishing steps may be used in order to finish the device, such as computer numerical control machining.
- the surgeon is able to implant the device.
- a surgeon may be able to decide where to cut the bone, the orientation and placement of the device 10 on the bone, and customize the device for a particular bone.
- the surgical procedure may vary depending on the particular patient and the surgeon's preferences.
- the procedure may generally include making an incision in the limb in order to expose the bone and cutting the end of the bone in order to size the bone to be positioned within the sleeve portion 12. For example, the tip of the bone or any irregularities may be removed in order to position the bone within the sleeve portion 12.
- the surrounding skin and tissue may then be reflected in order to expose the bone, and any minor modifications to the bone and skin may be made to ensure a proper fit before securing the device 10 to the bone.
- the bone may then be positioned within the sleeve portion 12, and the end of the bone and/or surrounding soft tissue could abut the flange portion 14 or be positioned proximate thereto.
- FIG. 9 shows a limb 60 having the tissue surrounding the bone displaced and the sleeve portion 12 positioned on the end of the bone. Once the bone is positioned within the sleeve portion 12, holes may be drilled for receiving the fasteners 28.
- the drill may be guided with a drill guide, or the holes defined in the sleeve portion 12 may be used as a drill guide.
- the fasteners 28 are then inserted through the holes to secure the device 10 to the bone.
- the subcutaneous tissue may be replaced or removed in order to properly position the tissue around the sleeve portion 12.
- the skin, tissue, muscles, tendons, and/or fascia may be reattached with sutures around the device 10 such that the flange portion abuts the surrounding skin, tissue, muscles, tendons, and/or fascia as shown in FIG. 10.
- Images may be made of the limb following surgery using techniques such as radiographs, CT scans, dual-energy x-ray absorptiometry (DEXA) scanning, and other suitable imaging methods in order to confirm the position of the device 10.
- the surgeon may monitor the progress of the fixation of the device by taking bone biopsies or further images.
- a prosthetic device 42 may be attached to the post portion 16, such as shown in FIG. 10.
- the device 10 is configured to reduce the incidence of infection by providing a barrier between the bone and the surrounding skin and subcutaneous tissue, and the flange portion 14 is configured to protect the soft tissue at the extremity of the limb.
- the combination of the fasteners and porous/textured/coated surfaces may facilitate integration of the device in the bone so as to provide adequate long-term fixation.
- the device is adaptable to a variety of limbs, as the device may be customized for each patient and automatically formed using an additive manufacturing process, which may result in more effective long-term fixation.
- the sleeve portion 12, flange portion 14, and post portion 16 may be integrally formed from a single piece of material thereby decreasing the likelihood of breakage and the cost of fabricating the implant.
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Prostheses (AREA)
Abstract
Divers modes de réalisation de la présente invention concernent, par exemple, un dispositif ostéointégré transcutané (10) permettant de fixer un dispositif prothétique à un os et au tissu environnant d’un membre. Le dispositif comprend une partie formant manchon (12) conçue pour recevoir au moins une partie de l’os et pour être fixée à l’os et une partie formant collerette (14) adjacente à la partie formant manchon et conçue pour venir en butée contre l’os et le tissu environnant. Le dispositif comprend en outre une partie postérieure (16) s’étendant depuis la partie formant collerette qui est conçue pour être accouplée au dispositif prothétique.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US2970008P | 2008-02-19 | 2008-02-19 | |
US61/029,700 | 2008-02-19 | ||
US8476908P | 2008-07-30 | 2008-07-30 | |
US61/084,769 | 2008-07-30 |
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WO2009105535A1 true WO2009105535A1 (fr) | 2009-08-27 |
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PCT/US2009/034512 WO2009105535A1 (fr) | 2008-02-19 | 2009-02-19 | Dispositif ostéointégré transcutané pour prothèses |
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WO2013048589A1 (fr) | 2011-06-06 | 2013-04-04 | University Of Utah Research Foundation | Système d'implant prothétique ostéo-intégré percutané |
US20140195002A1 (en) * | 2011-06-06 | 2014-07-10 | University Of Utah Research Foundation | Percutaneous osseointegrated implant assembly for use in supporting an exo-prosthesis |
US9308103B1 (en) | 2013-08-20 | 2016-04-12 | David T. Kluger | Osseointegrated mount for prosthetic limb and peripheral nerve interface |
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US10342554B2 (en) | 2016-06-17 | 2019-07-09 | Socovar, L.P. | Limb sparing in mammals using patient-specific endoprostheses and cutting guides |
ES2736410A1 (es) * | 2019-07-12 | 2019-12-30 | Univ Madrid Complutense | Endoprótesis a medida para huesos largos de animales |
US10792154B2 (en) | 2016-06-17 | 2020-10-06 | Socovar, L.P. | Limb sparing in mammals using patient-specific endoprostheses and cutting guides |
WO2021071235A1 (fr) * | 2019-10-11 | 2021-04-15 | 국립암센터 | Implant pour os amputé ayant une bride de maille pour relier directement une prothèse à un squelette |
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