WO2009105535A1

WO2009105535A1 - Transcutaneous osseointegrated device for prostheses

Info

Publication number: WO2009105535A1
Application number: PCT/US2009/034512
Authority: WO
Inventors: Ola L.A. Harrysson; Denis J. Marcellin-Little
Original assignee: North Carolina State University
Priority date: 2008-02-19
Filing date: 2009-02-19
Publication date: 2009-08-27

Abstract

Various embodiments of the present invention provide, for example, a transcutaneous osseointegrated device (10) for fixating a prosthetic device to a bone and surrounding tissue of a limb. The device includes a sleeve portion (12) configured to receive at least a portion of the bone and be fixated to the bone and a flange portion (14) adjacent to the sleeve portion and configured to abut the bone and surrounding tissue. The device further includes a post portion (16) extending from the flange portion that is configured to be coupled to the prosthetic device.

Description

TRANSCUTANEOUS OSSEOINTEGRATED DEVICE FOR PROSTHESES

FIELD OF INVENTION

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.

BACKGROUND OF THE INVENTION

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.

The utility of limb prostheses, particularly weight-bearing prosthetic devices (such as artificial legs and/or feet), is often dramatically increased if the prosthetic device is anchored to and/or embedded in a bone structure of a residual limb. However, 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. Furthermore, the onset of infection in such conventional systems may result in the need for the complete removal and/or replacement of the transcutaneous member. Because such systems often include a 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. Furthermore, 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. Thus, 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.

Thus, there remains a need in the art for an improved transcutaneous device. In particular, there is a need for a transcutaneous device that is configured to reduce the incidence of infection. Moreover, there is a need for a transcutaneous device that may be sufficiently integrated in the bone of the limb so as to provide adequate fixation. Furthermore, there is a need for a transcutaneous device that is adaptable to a variety of limbs.

SUMMARY OF THE INVENTION The above and other needs may be met by embodiments 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. According to one embodiment, 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.

According to various aspects of the device, 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. Similarly, 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. Moreover, 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. Alternatively, the fasteners may be configured to extend through the sleeve portion and into the central canal of the bone, such as for larger bones.

Furthermore, the post portion may be configured for threaded engagement with the prosthetic device. For example, the post portion may include a threaded surface, and 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). In addition, 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. Moreover, 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.

BRIEF DESCRIPTION OF THE DRAWINGS Various embodiments of the invention will be better understood by reference to the

Detailed Description of Various Embodiments of the Invention when taken together with the attached drawings, wherein: 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.

2;

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; and FIG. 10 is a perspective view of the transcutaneous osseointegrated device of FIG.

9 having a prosthetic device coupled thereto.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS OF THE INVENTION

Various embodiments of the present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, various embodiments of the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

As shown generally in FIG. 1, 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. Generally, 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.

Referring again to FIG. 1, 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. In particular, the sleeve portion 12 may have a slightly smaller diameter opening than at its opposite end adjacent to the flange portion 14. Although the sleeve portion 12 may have a circular opening, 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. Thus, 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. For example, 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. Moreover, FIG. 4 shows that the inner surface 24 of the thin wall 20 may also be textured/coated/porous. For instance, the textured surface could be rough, raised, or other uneven surface. According to one embodiment, 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. 7,014,661, which is hereby incorporated by reference in its entirety herein. Moreover, 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, ceramics, collagen, autologous bone, allogenic bone, xenogenic bone, coralline, and derivates or combinations thereof, or other biologically produced composite materials containing calcium or hydroxyapatite structural elements. In addition, 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. Alternatively, 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. Although only a lower portion of 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. Similarly, although 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. In particular, 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. Various types of fasteners 28 may be employed, such as fasteners having a slotted, cruciform, hexagonal, or star head 30 configuration. Depending on the size of the bone and/or fasteners 28, 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. However, the location and/or number of fasteners 28 may be modified for a particular patient or amount of fixation desired.

Furthermore, 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. For instance, 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. Moreover, the inner and/or outer surfaces of the rod member 58 may be textured, coated, and/or porous for facilitating bone fixation. In addition, it is understood that 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). Thus, 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. 2 and 4. 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. In addition, 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. Thus, 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. For example, 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). According to one embodiment, the opening 46 is tapered and capable of receiving a correspondingly tapered end 48 of the stem 44. Furthermore, 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. More specifically, 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. It is understood that the opening 46 may be different sizes and configurations for mating with a variety of stems 44. For example, the opening may be circular in cross section and configured to receive a cylindrical stem and secured therein with a fastener. Or, the opening of the post portion 16 could include threads configured to engage a threaded stem. Furthermore, 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.

According one embodiment, 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. For example, 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. According to one embodiment, an energy beam (laser or electron beam) may be used. In one aspect, 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. According to exemplary embodiments, 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,

Harrysson, Ola L. A., 2008, Digital Fabrication of Dental Restoration: The Final Step in the Digital Process, Dentistry Today, In Press; Cormier, Denis R., Harrysson, Ola L. A., Mahale, Tushar, West, Harvey, 2007, Freeform Fabrication of Titanium Aluminide Via Electron Beam Melting, Research Letters in Material Science, Volume 2007, Article ID 34737, 4 pages; O. Cansizoglu, O. L. A. Harrysson, H. A. West II, D. R. Cormier, T.

Mahale, 2008, Applications of Structural Optimization in Direct Metal Fabrication, Rapid Prototyping Journal, Vol. 14, No. 2, pp. 114-122; Marcellin-Little, Denis, Harrysson, Ola L. A., Cansizoglu, Omer, 2008, In Vitro Evaluation of a Custom Cutting Jig and Custom Plate for Canine Tibial Plateau Leveling. American Journal of Veterinary Research, Vol. 69, No. 7, July 2008 pp. 961-966; Harrysson, Ola L. A., Omer Cansizoglu, Denis J. Marcellin-Little, Denis R. Cormier, and Harvey A. West II. 2008. "Direct Metal Fabrication of Titanium Implants with Tailored Materials and Mechanical Properties Using Electron Beam Melting Technology," Materials Science & Engineering C, Vol. 28, No 3, pp. 366-373; and Harrysson, O. L. A., and Denis R. Cormier. 2006. "Direct Fabrication of Custom Orthopedic Implants using Electron Beam Melting Technology," Chapter 9, in Advanced Manufacturing Technology for Medical Applications, Eds. I. Gibson, John Wiley & Sons, Ltd., p 193-208. Moreover, 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.

Once the model is complete and the device 10 designed for a limb, the surgeon is able to implant the device. Using the model, 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. For instance, 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. After allowing for adequate recovery time, a prosthetic device 42 may be attached to the post portion 16, such as shown in FIG. 10.

Therefore, embodiments of the present invention may provide several advantages. For example, 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. Moreover, 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. Furthermore, 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. In addition, 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.

Many modifications and other various embodiments of the invention set forth herein will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the various embodiments of the invention are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

THAT WHICH IS CLAIMED:

1. A transcutaneous osseointegrated device for fixation of a prosthetic device to a bone and surrounding tissue of a limb, the device comprising: a sleeve portion configured to receive at least a portion of the bone and be fixated to the bone; a flange portion adjacent to the sleeve portion and configured to abut the bone and surrounding tissue, the flange portion have a first side facing the sleeve portion and an opposing second side; and a post portion extending from the second side of the flange portion and configured to be coupled to the prosthetic device.

2. The device of Claim 1, wherein the sleeve portion comprises an opening and a thin wall having an inner and outer surface such that the bone is configured to be received within the opening and such that the thin wall provides an interface between both its inner surface and the bone and between its outer surface and the surrounding tissue.

3. The device of Claim 2, wherein at least a portion of the inner surface of the sleeve portion is textured, coated, and/or porous to facilitate bone fixation.

4. The device of Claim 2, wherein at least a portion of the outer surface of the sleeve portion is textured, coated, and/or porous to promote tissue in-growth and/or on- growth.

5. The device of Claim 1, wherein at least a portion of the first side of the flange portion is textured, coated, and/or porous to promote in-growth and/or on-growth with the surrounding tissue.

6. The device of Claim 1 , wherein the flange portion extends radially outward from the sleeve portion and the first side of the flange portion is configured to cup the end of the bone and surrounding tissue.

7. The device of Claim 1 , wherein the sleeve portion comprises a plurality of holes for receiving respective fasteners.

8. The device of Claim 7, wherein each fastener comprises a respective head, and wherein each head is configured to engage the sleeve portion and lock in place using a Morse taper or thin thread.

9. The device of Claim 7, wherein the fasteners are configured to extend through the sleeve portion and into a central canal of the bone.

10. The device of Claim 1, wherein the post portion is configured for threaded engagement with the prosthetic device.

11. The device of Claim 1 , wherein the post portion comprises a threaded surface and further comprising a threaded nut comprising a hole configured to receive a stem of the prosthetic device and engage the threaded surface of the post portion.

12. The device of Claim 11 , wherein the post portion comprises a tapered hole that is configured to mate with a correspondingly tapered end of the stem.

13. The device of Claim 1, wherein the sleeve portion, flange portion, and post portion are integrally formed from a single piece of material.

14. 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 comprising: integrally forming a transcutaneous osseointegrated device comprising a sleeve portion, a flange portion, and a post portion using an additive manufacturing process.

15. The method of Claim 14, wherein the sleeve portion is configured to receive at least a portion of the bone and be fixated to the bone, wherein the flange portion extends from the sleeve portion and is configured to abut the bone and surrounding tissue, and wherein the post portion extends from the flange portion and is configured to be coupled to the prosthetic device.

16. The method of Claim 14, wherein the additive manufacturing process comprises an energy-beam additive manufacturing process.

17. The method of Claim 14, further comprising 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.

18. A method for fixating a prosthetic device to a bone and surrounding tissue of a limb with a transcutaneous osseointegrated device, the method comprising: 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.

19. The method of Claim 18, further comprising extending a plurality of fasteners through the sleeve portion and into the bone.

20. The method of Claim 18, further comprising threadably attaching the prosthetic device to the post portion.