ENGINEERED BONE GRAFT IMPLANT AND METHODS OF USING THE SAME

Abstract

A bone graft implant and methods of using the same are provided herein.

Claims

1. A bone graft implant comprising: a. a first portion that is porous; and b. a second portion that is porous; wherein at least one of the first portion and second portion include one or more reliefs and wherein the second portion of the bone graft implant is configured to be placed proximate to a bone surface.

2. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprises autograft cortical bone, autograft cancellous bone, autograft cartilage, or a combination thereof.

3. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprises allograft cortical bone, allograft cancellous bone, allograft cartilage, or a combination thereof.

4. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprises xenograft cortical bone, xenograft cancellous bone, xenograft cartilage, or a combination thereof.

5. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprises synthetic cortical bone, synthetic cancellous bone, synthetic cartilage, or a combination thereof.

6. The bone graft implant of claim 1, wherein at least one of the first portion and the second portion comprise one or more of hyaluronic acid, B-TCP, ceramic, PLA, PLGA, and PLLA.

7. The bone graft implant of claim 1, wherein at least one of the first portion and the second portion comprise growth factors, platelet rich plasma, platelets, cells, peptides, or a combination thereof.

8. The bone graft implant of claim 1, wherein the bone graft implant has an outer diameter of about 3 mm to about 10 mm.

9. The bone graft implant of claim 1, wherein the bone graft implant has a length of about 20 mm to about 120 mm.

10. The bone graft implant of claim 1, wherein the bone graft implant is a composite.

11. The bone graft implant of claim 1, wherein the bone graft implant comprises a circular cross section, a rectangular cross section, or a trapezoidal cross section.

12. The bone graft implant of claim 1, wherein the bone graft implant is substantially flat.

13. The bone graft implant of claim 1, wherein at least one of the first portion and the second portion comprise a convex portion, a concave portion, or a combination thereof.

14. The bone graft implant of claim 1, wherein at least one of the first portion and the second portion comprise a channel.

15. The bone graft implant of claim 1, wherein at least one of the first portion and second portion of are configured to buttress a bone, metal rod, or PEEK rod.

16. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprise scalloped or V-shaped reliefs.

17. The bone graft implant of claim 1, wherein at least one of the first portion and second portion comprise U-shaped reliefs.

18. The bone graft implant of claim 1, wherein bone graft implant is pre-hydrated.

19. The bone graft implant of claim 1, wherein the first portion is more porous than the second portion.

20. The bone graft implant of claim 1, wherein the second portion is more porous that the first portion.

21. The bone graft implant of claim 1, wherein the first portion and second portion have about the same porosity.

22. The bone graft implant of claim 1, wherein the porosity of the first portion is uniform.

23. The bone graft implant of claim 1, wherein the porosity of the first portion is non-uniform.

24. The bone graft implant of claim 1, wherein the first portion comprises a porous gradient where the pore size at a surface of the first portion is greater than the pore size at the interior of the first portion.

25. The bone graft implant of claim 1, wherein the first portion comprises a porous gradient wherein the pore size at a surface of the first portion is less than the pore size at the interior of the first portion.

26. The bone graft implant of claim 1, wherein the first portion comprises a porous gradient where the pore size at a first surface of the first portion is greater than the pore size at a second surface of the first portion.

27. The bone graft implant of claim 26, wherein the pore sizes of the porous gradient vary lengthwise.

28. The bone graft implant of claim 1, wherein the porosity of the second portion is uniform.

29. The bone graft implant of claim 1, wherein the porosity of the second portion is non-uniform.

30. The bone graft implant of claim 1, wherein the second portion comprises a porous gradient where the pore size at a surface of the second portion is greater than the pore size at the interior of the second portion.

31. The bone graft implant of claim 1, wherein the second portion comprises a porous gradient wherein the pore size at a surface of the second portion is less than the pore size at the interior of the second portion.

32. The bone graft implant of claim 1, wherein the second portion comprises a porous gradient where the pore size at a first surface of the second portion is greater than the pore size at a second surface of the second portion.

33. The bone graft implant of claim 32, wherein the pore sizes of the porous gradient vary lengthwise along the length of the second portion.

34. The bone graft implant of claim 1, comprising a cannula that axially traverses the length of the bone graft implant.

35. The bone graft implant of claim 1, comprising one or more securing holes that radially traverses the width of the bone graft implant.

36. The bone graft implant of claim 1 comprising a bioincorporable membrane disposed proximate to at least one of the first portion and the second portion of the bone graft implant.

37. The bone graft implant of claim 36, wherein the bioincorporable membrane is secured to the bone graft implant by one or more membrane fixation elements.

38. The bone graft implant of claim 37, wherein the membrane fixation elements comprise sutures, screws, adhesive, or a combination thereof.

39. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises a fibrin membrane.

40. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises a platelet rich fibrin membrane.

41. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises one or more of autograft amnion, autograft chorion, autograft dermis, autograft fascia, or a combination thereof.

42. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises one or more of allograft amnion, allograft chorion, allograft dermis, allograft fascia, or a combination thereof.

43. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises one or more of xenograft amnion, xenograft chorion, xenograft dermis, xenograft fascia, or a combination thereof.

44. The bone graft implant of claim 36, wherein the bioincorporable membrane is a platelet rich fibrin membrane.

45. The bone graft implant of claim 36, wherein the bioincorporable membrane is a platelet rich fibrin matrix.

46. The bone graft implant of claim 36, wherein the bioincorporable membrane comprises growth factors, platelet rich plasma, cells, peptides, or a combination thereof.

47. The bone graft implant of claim 1, wherein at least one of the first portion and the second portion are configured to receive one or more bone fixation elements to affix the bone graft implant to bone.

48. The bone graft implant of claim 47, wherein the bone fixation elements comprise sutures, screws, staples, adhesive, or a combination thereof.

49. The bone graft implant of claim 1, comprising a concave collar at one or both ends of the bone graft implant.

50. The bone graft implant of claim 1, comprising an annulus at one or both ends of the bone graft implant, wherein the annulus has a smaller diameter as compared to the body of the bone graft implant.

51. The bone graft implant of claim 1, wherein one or both ends of the bone graft implant are clamp shaped.

52. The bone graft implant of claim 1, wherein one or both ends of the bone graft implant are concave.

53. A method for treating bone in a patient in need thereof, the method comprising introducing a bone graft implant of claim 1 to a surface of the patient's bone and affixing the bone graft implant to said surface of the patient's bone.

54. A method for preparing a bone graft implant of claim 1 comprising modifying the porosity of at least one of the first portion and second portion comprising the step of demineralizing the first portion and/or the second portion of the bone graft implant.

55. A kit for treating bone in a patient in need thereof, the kit comprising a bone graft implant according to claim 1 and an introducing device configured to introduce the bone graft implant at a surface of the patient's bone.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The foregoing summary and the following detailed description of the exemplary embodiments of the invention may be further understood when read in conjunction with the appended drawings, in which:

[0024] FIGS. 1A to 1C illustrate a bone graft implant embodiment of the invention that includes two U-shaped reliefs about the cylindrical body in a top-down view (FIG. 1A), a side-on view (FIG. 1B), and a perspective side-on view (FIG. 1C).

[0025] FIGS. 2A to 2C illustrate a bone graft implant embodiment of the invention that includes two U-shaped reliefs about the square-tubular body in a top-down view (FIG. 2A), a side-on view (FIG. 2B), and a perspective side-on view (FIG. 2C).

[0026] FIGS. 3A to 3C illustrate a bone graft implant embodiment of the invention that includes a plurality of scalloped reliefs (or v-shaped) reliefs on cortical bone side facing (first portion) and cancellous bone side facing (second portion) of the cylindrical body in a top-down view (FIG. 3A), a side-on view (FIG. 3B), and a perspective side-on view (FIG. 3C).

DETAILED DESCRIPTION OF THE INVENTION

[0027] Referring now to the figures, wherein like elements are numbered alike throughout, FIGS. 1A to 1C describe a bone graft implant of the invention 100 that includes two U-shaped reliefs 140 and is generally cylindrical. The bone graft implant 100 may include a body 110 having a first portion 120 and a second portion 130, where the second portion 130 may be configured for placement proximate to a bone surface in a patient. The body 110 may further include a cannula 111 that may extend from one end 112 to another end 112 of the body 110. In some embodiments, the bone graft implant 100 may include a bioincorporable membrane or matrix 150 that may be affixed to the body 110 with membrane fixation element or elements 152 that are connected to the body 110 through radial holes 151.

[0028] As used herein, the term bioincorporable as applied to any materials or components refers to any such materials or components that may be incorporated into a tissue and thereby become substantially indistinguishable from the tissue.

[0029] In some embodiments, the bone graft implant 100 may include bioabsorbable and/or biodegradable materials. As used herein, the terms biodegradable, biodegradation, degradable, degradation, degraded, bioerodible, erodible or erosion are used interchangeably and are understood as the breaking down or the susceptibility of a material or component to break down or be broken into products, byproducts, components or subcomponents over time such as days, weeks, months or years. As used herein, the terms bioabsorbable, absorbable, resorbable and bioresorbable are used interchangeably and are defined as the biologic elimination of any materials or components through metabolic degradation and/or excretion.

[0030] In some embodiments, the bone graft implant 100 may include body 110 that may have a circular cross-section, square or rectangular cross-section, or trapezoidal cross section. In some embodiments, body 110 includes a circular cross-section and is cylindrical. Alternatively, the body 110, or a segment or portion thereof, may be flat, convex, or concave. In some embodiments, the body 110 may have an outer diameter of about 3 mm to about 10 mm, or about 3.5 mm to about 9.5 mm. In some embodiments, the cannula 111 may have a diameter of about 0.5 mm to about 3.0 mm, or about 1 mm to about 2.5 mm. In some embodiments, the body 110 may have a length, along the axis of the body 110, of about 15 mm to about 125 mm, or about 20 mm to about 120 mm, or about 25 mm to about 115 mm, or about 30 mm to about 110 mm, or about 35 mm to about 105 mm, or about 40 mm to about 100 mm, or about 45 mm to about 95 mm, or about 50 mm to about 90 mm, or about 55 mm to about 85 mm, or about 60 mm to about 80 mm. In some embodiments, the body 110 may have a length of greater than about 20 mm, or greater than about 25 mm, or greater than about 30 mm, or greater than about 35 mm, or greater than about 40 mm, or greater than about 45 mm, or greater than about 50 mm, or greater than about 55 mm, or greater than about 60 mm, or greater than about 65 mm, or greater than about 65 mm, or greater than about 70 mm, or greater than about 75 mm, or greater than about 80 mm, or greater than about 85 mm, or greater than about 90 mm, or greater than about 95 mm, or greater than about 100 mm, or greater than about 105 mm, or greater than about 110 mm, or greater than about 115 mm, or greater than about 120 mm.

[0031] In some embodiments, the graft body 110 may include a first portion 120 and a second portion 130. The first and second portions 120 and 130 may be composed of autograft cortical bone, autograft cancellous bone, autograft cartilage, or a combination thereof. In some embodiments, the first and second portions 120 and 130 may be composed of allograft cortical bone, allograft cancellous bone, allograft cartilage, or a combination thereof. In some embodiments, the first and second portions 120 and 130 may be composed of xenograft cortical bone, xenograft cancellous bone, xenograft cartilage, or a combination thereof. In some embodiments, the first and second portions 120 and 130 may be composed of synthetic cortical bone, synthetic cancellous bone, synthetic cartilage, or a combination thereof. In some embodiments, the first and second portions 120 and 130 may include one or more of hyaluronic acid, B-TCP, ceramic, PLA, PLGA, and PLLA. In some embodiments, the first and second portions 120 and 130 may be hydrated and/or pre-hydrated with a fluid such as saline, water, alcohol, or other biocompatible fluid.

[0032] In some embodiments, the first portion and second portion 120 and 130 may include a composite of one or more materials. Alternatively, the first and second portion 120 and 130 may be uniform.

[0033] In some embodiments, the first portion 120 or second portion 130 may include a channel that may be configured to abut or receive a portion of bone or metal rods/screws or PEEK rods/screws.

[0034] In some embodiments, the first and second portions 120 and 130 may include growth factors, plasma (e.g., platelet rich plasma), platelets (e.g., intact platelets), cells, peptides, or a combination thereof.

[0035] In some embodiments, the first and second portions 120 and 130 may be porous and may include an open-cell pore structure and/or a closed-cell pore structure. In some embodiments, the first portion 120 may have a pore size that is greater than the pore size of the second portion 130. In some embodiments, the first portion 120 may have a pore size that is smaller than the pore size of the second portion 130. In some embodiments, the first portion 120 and the second portion 130 may have about the same porosity or pore size. In some embodiments, the pores of the first portion 120 and/or the second portion 130 may have uniform pore sizes. In some embodiments, the pores of the first portion 120 and/or the second portion 130 may have non-uniform pore sizes.

[0036] In some embodiments, the portions of the body 110 may include a porous gradient where the pore size at a surface of the portion is greater than the pore size at the interior of the portion. In some embodiments, the portions of the body 110 may include a porous gradient wherein the pore size at a surface of the portion is less than the pore size at the interior of the portion. In some embodiments, the portions of the body 110 may include a porous gradient where the pore size at a surface of the portion is greater than the pore size at a second surface of the portion. In some embodiments, the portions of the body 110 may include pore sizes that vary lengthwise along the axis of the body 110.

[0037] The reliefs 140 allow the bone graft to flex upon introduction to a patient's bone. In addition, the reliefs 140 may allow the bone graft implant to be conformable and/or moldable to an irregularly shaped bone surface. In some embodiments, the reliefs 140 may include a plurality of reliefs. In some embodiments, the reliefs 140 may include scalloped reliefs, V-shaped reliefs, and/or U-shaped reliefs. FIGS. 1A to 1C demonstrate reliefs 140 that are U-shaped.

[0038] In some embodiments, the bone graft implant 100 includes a bioincorporable membrane or matrix 150. In some embodiments, the bioincorporable membrane 150 may include a fibrin membrane or matrix. In some embodiments, the bioincorporable membrane 150 may include a platelet rich fibrin membrane. In some embodiments, the bioincorporable membrane 150 may include one or more of autograft amnion, autograft chorion, autograft dermis, autograft fascia, or a combination thereof. In some embodiments, the bioincorporable membrane 150 may include one or more of allograft amnion, allograft chorion, allograft dermis, allograft fascia, or a combination thereof. In some embodiments, the bioincorporable membrane 150 may be a platelet rich fibrin membrane or matrix. In some embodiments, the bioincorporable membrane 150 may include growth factors, plasma (e.g., platelet rich plasma), cells, peptides, or a combination thereof.

[0039] In some embodiments, the bioincorporable membrane 150 may be secured to the body 110 with one or more membrane fixation elements 152. The membrane fixation elements 152 may communicate with the body 110 through one or more securing holes 151 that may radially traverse the width of the body 110. In some embodiments, the membrane fixation elements 152 may include sutures, screws, adhesive, or a combination thereof. In certain embodiments, the fixation element 152 may include sutures that are interwoven between the bioincorporable membrane 150 and the body 110.

[0040] In some embodiments, the bioincorporable membrane 150 may be FIBRINET. In some embodiments, the bioincorporable membrane 150 may include a fibrin web, matrix, or membrane as described and prepared in one or more of U.S. Pat. Nos. 6,368,298, 6,979,307, 7,745,106, and 8,802,362, the entirety of which are incorporated herein by reference.

[0041] In some embodiments, the bioincorporable membrane 150 includes, or may be implanted with, one or more of an antibiotic, an antimicrobial, an antibiofilm, an analgesic, a cancer therapeutic, a platelet-growth factor, bone morphogenic protein cells for gene therapy, stem cells for additional uses, and other hormones. Other therapeutic agents which can be administered may also be included. Examples of antibiotics include, but are not limited to, ampicillin, erythromycin and tobramycin. Antimicrobials include, but are not limited to silver. Antibiofilms include, but are not limited to salicylic acid. Analgesics include, but are not limited to, aspirin and codeine. Cancer therapeutics include, but are not limited to, 5-fluoro-uracil.

[0042] Accordingly, in some embodiments of the invention, the bone graft implant 100 may act as a delivery vessel, or mechanical delivery device, for delivering the bioincorporable membrane 150, as described herein, to selected tissues of the body which may include, without limitation, bone tissue. For example, the bioincorporable membrane 150 may include, or have deposited thereon, an antibiotic, an antimicrobial, an antibiofilm, an analgesic, a cancer therapeutic, a platelet-growth factor, bone morphogenic protein cells, or stem cells for the treatment of diseases that require such delivery.

[0043] In certain embodiments, one or more of the ends 112 of the body 110 may include a portion that may receive a bone fixation element that may be provided to affix the bone graft implant 100 to a portion of a patient's bone. In some embodiments, the bone fixation element may include bone, metal rods/screws, or PEEK rods/screws (e.g., bone screws with associated washers), sutures, staples, adhesive, or a combination thereof.

[0044] In some embodiments, the ends 112 may include a concave collar at one or both ends 112 of the bone graft implant 100. In some embodiments, the ends 112 may include an annulus having a diameter that is less than or smaller than the diameter of the body 110 of the bone graft implant 100. In some embodiments, one or both ends 112 of the body 110 may have a convex shape or concave shape. In some embodiments, one or both ends 112 of the body 110 may be clamp shaped.

[0045] As shown in FIGS. 2A to 2C, some embodiments of the invention includes a bone graft implant 200. The bone graft implant 200 includes a body 210 having a generally square cross section, but with U-Shaped reliefs 240. The body 210 includes first portion 220 and second portion 230. Furthermore, the body 210 includes a cannula 211 that traverses the length of body 210 from end 212 to the other end 212. The ends 212 are configured to be concave as shown in FIGS. 2A and 2C. In some embodiments, the bone graft implant 200 may include a bioincorporable membrane or matrix 250 that may be affixed to the body 210 with membrane fixation elements 252 that are connected to the body 210 through radial holes 251. As shown in FIGS. 2A and 2B, the membrane fixation element 252 may be sutures.

[0046] As shown in FIGS. 3A to 3C, some embodiments of the invention includes a bone graft implant 300. The bone graft implant 300 includes a body 310 having a generally circular section, but with scalloped or V-shaped reliefs 340 along the surfaces of the first portion 320 and second portion 330. Furthermore, the body 310 includes a cannula 311 that traverses the length of body 310 from end 312 to the other end 312. The ends 312 are configured to be concave as shown in FIGS. 3A and 3C. In some embodiments, the bone graft implant 300 may include a bioincorporable membrane or matrix 350 that may be affixed to the body 310 with membrane fixation elements 352 that are connected to the body 310 through radial holes 351. As shown in FIGS. 3A and 3B, the membrane fixation element 352 may be sutures.

[0047] In some embodiments, the invention includes a method for treating bone in a patient in need thereof, the method including providing, affixing, or otherwise introducing a bone graft implant described herein to a surface of the patient's bone and affixing the bone graft implant to said surface of the patient's bone. In some embodiments, the bone graft implant may be introduced through an introducing device or system, which may include an endoscopic device or devices. In some embodiments, a bone graft implant described herein may be introduced to a surface of the patient's bone through a surgical procedure. In some embodiments, the surgical procedures may include open surgery, laparoscopic surgery, endoscopic surgery, arthroscopic surgery, and the like. In some embodiments, the surgical procedures may include minimally invasive surgical procedures (e.g., MIS), which include, without limitation, laparoscopic surgical procedures, endoscopic surgical procedures, arthroscopic surgical procedures, and the like, that involve the use of a relatively small incision, as compared to open surgery, and an endoscope. In some embodiments, the bone graft implants described herein may be used in MIS approaches and therapies. In certain embodiments, the bone graft implants described herein may be used to treat lumbar facet joints, which result in lower back pain with mild stenosis. In certain embodiments, the bone graft implants described herein may be used to provide orthopaedic bone fusion. In some embodiments, the bone graft implants described herein may be used to fuse fractured bones in the spine, femur, tibia, humerus, ulna, radius, and/or bones of the extremities. In some embodiments, the bone graft implants may be used to fuse one or more vertebrae, one or more long bones, or one or more short bones, and the like.

[0048] In some embodiments, the invention may include a method for preparing a bone graft implant as described herein. The methods may include modifying the porosity of at least one of the first portion and second portion of the bone graft implant by demineralizing the first portion and/or the second portion of the bone graft implant.

[0049] In some embodiments, the invention may include a kit for treating bone or another related disease in a patient in need thereof. In some embodiments, the kit may include a bone graft implant, as described herein, and an introducing device configured to introduce the bone graft implant at a surface of the patient's bone.

[0050] The bone graft implants described herein may be positioned against cortical and/or cancellous bone. Furthermore, such implants may wick platelet rich fibrin gel, bone marrow, or bone marrow aspirate (BMA). Additionally, such grafts are conformable and may be molded to match bone tissue. In some embodiments, the bone graft implants may be delivered through an endoscope with MIS. Preparation of the materials described herein, including the bioincorporable membrane does not require centrifugation.

[0051] A number of patent and non-patent publications are cited herein in order to describe the state of the art to which this invention pertains. The entire disclosure of each of these publications is incorporated by reference herein.

[0052] While certain embodiments of the invention have been described and/or exemplified above, various other embodiments will be apparent to those skilled in the art from the foregoing disclosure. The invention is, therefore, not limited to the particular embodiments described and/or exemplified, but is capable of considerable variation and modification without departure from the scope and spirit of the appended claims.

[0053] Moreover, as used herein, the term about means that dimensions, sizes, formulations, parameters, shapes and other quantities and characteristics are not and need not be exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, a dimension, size, formulation, parameter, shape or other quantity or characteristic is about or approximate whether or not expressly stated to be such. It is noted that embodiments of very different sizes, shapes and dimensions may employ the described arrangements.

[0054] Furthermore, the transitional terms comprising, consisting essentially of and consisting of, when used in the appended claims, in original and amended form, define the claim scope with respect to what unrecited additional claim elements or steps, if any, are excluded from the scope of the claim(s). The term comprising is intended to be inclusive or open-ended and does not exclude any additional, unrecited element, method, step or material. The term consisting of excludes any element, step or material other than those specified in the claim and, in the latter instance, impurities ordinary associated with the specified material(s). The term consisting essentially of limits the scope of a claim to the specified elements, steps or material(s) and those that do not materially affect the basic and novel characteristic(s) of the claimed invention. All implants, devices, kits, and methods described herein that embody the invention can, in alternate embodiments, be more specifically defined by any of the transitional terms comprising, consisting essentially of, and consisting of.