BONE INTRAMEDULLARY FIXATION SCAFFOLD

Abstract

A new shape changing bone implant and instrument for the fixation of structures to include bone tissue. This new implant stores elastic mechanical energy to exert force on fixated structures to enhance their security and in bone affect its healing response. This unique implant locks into bone and then simultaneously expands and shortens to lock into bone and then pull the bone segments together. This implant once placed changes shape in response to geometric changes in the implant's and bone's materials structure. The implant may be fabricated from any biocompatible material that acts elastically when deformed including but not limited to nitinol, stainless steel, titanium, and their alloys as well as polymers such as polyetheretherketone, silicone elastomer and polyethylene. The implant is advanced over prior devices due to its: (1) method of operation, (2) high strength, (3) method of insertion, (4) compressive force temperature independence, (5) energy storing implant retention and delivery system, (6) compatibility with reusable or single use product configuration, (7) ability to act as a scaffold to conduct healing bone through the implant, (8) efficient and cost effective manufacturing methods, and (9) reduction in the steps required to place the device.

Claims

1-28. (canceled)

29. A method of fixating a first bone and a second bone comprising the steps of: (a) making holes in the first bone and the second bone to receive an implant, wherein (i) the implant has a first end, a second end, and a body, (ii) the first end comprises one or more first end locking prongs, (iii) the second end comprises one or more second end locking prongs, (iv) the body comprises one or more fenestrations, and (v) the implant is coupled to an instrument that extends length of the implant and that constrains bulge of the fenestrations; (b) inserting the first end of the implant into the first bone; (c) releasing the implant to change shape of the implant within the first bone, wherein the one or more first end locking prongs lock the first end within the first bone to prevent the release of the implant from the first bone and to resist rotation of the implant within the first bone; (d) placing the second bone over the second end of the implant; (e) releasing the implant to change shape of the implant within the second bone, wherein the one or more second end locking prongs lock the second end within the second bone to prevent the release of the implant from the second bone and to resist rotation of the implant within the second bone, and (f) removing the instrument from the implant which allows the length of the implant to shorten and the bulge of the fenestrations to expand, wherein pushing the first bone and the second bone are pulled toward each other and compressed at a healing interface between together until the first bone contacts and the second bone.

30. A fixation device having a long axis, wherein (a) the fixation device comprises a first end, a second end, and a body; (b) the body is between the first end and the second end along the long axis of the fixation device; and (c) the fixation device is operable to change shape from a first shape to a second shape, wherein (i) the first shape has a different length than the second shape; (ii) the body comprises an elastic material; (iii) the body has a plurality of prongs on each of the first end and the second end; (iv) the body has a length changing section between the prongs on the first end and the second end; and (v) the length changing section is operable to shorten the length of the body along the long axis by bulging outward perpendicular to the long axis when the fixation device moves from the first shape toward the second shape.

31. The method of claim 29, wherein the body is a tubular shape.

32. The method of claim 29, wherein (a) the body has a long axis running from the first end the second end, and (b) the budge of the fenestrations is oriented along the long axis.

33. The method of claim 29, wherein the instrument is an internal mandrel or an external sleeve.

34. The method of claim 33, wherein the instrument is an internal mandrel.

35. The method of claim 34, wherein the implant further comprises a lock plate and a lumen, wherein the lock plate is integral to the lumen.

36. The method of claim 35, wherein the step of removing the instrument from the implant comprises using the internal mandrel to rotating the lock plate from a locked position to an unlocked position.

37. The method of claim 29, wherein the body comprises an elastic material.

38. The method of claim 37, wherein the elastic material comprises an elastic metal selected from a group consisting of nitinol, stainless steel, titanium, and alloys thereof.

39. The method of claim 38, wherein the shape memory material is nitinol.

40. The method of claim 29, wherein (i) the first end comprises a plurality of first end locking prongs, and (ii) the second end comprises a plurality of second end locking prongs.

41. The fixation device of claim 30, wherein the body is a tubular shape.

42. The fixation device of claim 30, wherein (a) the body has one or more fenestrations oriented along the long axis; and (b) the length changing section is operable to shorted the length of the body along the long axis by bulging the fenestrations outward perpendicular to the line axis when the fixation device moves from the first shape toward the second shape.

43. The fixation device of claim 30 further comprising an instrument that constrains the fixation device in the first shape, which instrument is operable to be removed from the fixation device such that the fixation device is released to move toward the second shape.

44. The fixation device of claim 43, wherein the instrument is an internal mandrel or an external sleeve.

45. The fixation device of claim 44, wherein the instrument is an internal mandrel.

46. The fixation device of claim 45, wherein the fixation device further comprises a lock plate and a lumen, wherein the lock plate is integral to the lumen.

47. The fixation device of claim 43, wherein the instrument is operable to be removed from the fixation device from the implant section by using the internal mandrel to rotating the lock plate from a locked position to an unlocked position.

48. The fixation device of claim 30, wherein the elastic material comprises an elastic metal selected from a group consisting of nitinol, stainless steel, titanium, and alloys thereof.

Description

DESCRIPTION OF DRAWINGS

[0046] FIG. 1a depicts an embodiment of the present invention of an implant of in its constrained configuration.

[0047] FIG. 1b depicts the implant of FIG. 1a in its released configuration.

[0048] FIG. 2a depicts an embodiment of the present invention of an implant constrained with in its instrument.

[0049] FIG. 2b depicts the implant and instrument of FIG. 2a with the implant released within its instrument.

[0050] FIG. 3a depicts the implant and instrument of FIG. 2a with the implant advanced and constrained within its instrument in preparation for implantation into bone.

[0051] FIG. 3b depicts the implant and instrument of FIG. 2a with the implant within bone prior to implant release.

[0052] FIG. 4a depicts the implant and instrument of FIG. 2a with the implant constrained within instrument showing instrument unlocking.

[0053] FIG. 4b depicts the implant and instrument of FIG. 2a with the implant being advanced through the instrument into bone.

[0054] FIG. 4c depicts the implant and instrument of FIG. 2a with the implant showing instrument release.

[0055] FIG. 5a depicts an implant of an embodiment of the present invention in a first bone.

[0056] FIG. 5b depicts the implant of FIG. 5a with the implant in the first bone and a second bone with a lock plate.

[0057] FIG. 5c depicts the implant of FIG. 5a with the implant in the first and second bone.

[0058] FIG. 6a depicts an end view of an implant of an embodiment of the present invention showing direction of rotation to cause disengagement of the prongs from bone.

[0059] FIG. 6b depicts the implant of FIG. 6a with a mandrel and a lock plate in its constrained configuration.

[0060] FIG. 6c depicts the implant of FIG. 6a with the mandrel and the lock plate in its released configuration.

[0061] FIG. 7a depicts an embodiment of an alternate implant holding mechanism with prongs and mandrel.

[0062] FIG. 7b depicts the implant holding mechanism of FIG. 7a with the alternate implant holding mechanism within an unconstrained implant lumen.

[0063] FIG. 7c depicts the implant holding mechanism of FIG. 7a with the alternate implant holding mechanism locked into constrained implant.

[0064] FIG. 8a depicts an embodiment of an alternate external implant holding mechanism and mandrel adjacent to unconstrained implant.

[0065] FIG. 8b depicts the implant holding mechanism of FIG. 8a with the alternate external implant holding mechanism and mandrel within and overlapping unconstrained implant.

[0066] FIG. 8c depicts the implant holding mechanism of FIG. 8a with the alternate external implant holding mechanism and mandrel locked into constrained implant.

[0067] FIG. 9 depicts use of a K-wire (360) to create a pilot hole in the proximal bone (200).

[0068] FIG. 10 depicts use of a drill (370) and drill stop (380) to drill a hole in the distal bone (210).

[0069] FIG. 11 depicts use of a drill (370) to drill a hole in the proximal bone (200).

[0070] FIG. 12 depicts implantation of the intramedullary fixation scaffold in the proximal bone (200).

[0071] FIG. 13 depicts removal of a locking pin and ring (410) and rotation of the instrument knob (120) to release the intramedullary fixation scaffold in the proximal bone (200).

[0072] FIG. 14 depicts insertion of the intramedullary fixation scaffold in the distal bone drill hole (220).

[0073] FIG. 15 depicts reduction of the distal bone on the proximal bone and removal of the lock plate (90).

[0074] FIG. 16 depicts insertion of a k-wire (360) through an adjacent joint and through the intramedullary fixation scaffold.

[0075] FIG. 17a depicts a lock plate (440) integral to the intramedullary fixation scaffold with the intramedullary fixation scaffold contracted in its length.

[0076] FIG. 17b depicts a lock plate (440) integral to the intramedullary fixation scaffold with the intramedullary fixation scaffold extended in its length.

REFERENCE NUMERALS

[0077] 10. tubular section [0078] 20. shape changing section [0079] 30. fixation section [0080] 40. bulge expanded [0081] 45. bulge contracted [0082] 50. prongs [0083] 60. push plate [0084] 70. conformation slots [0085] 80. lumen [0086] 90. lock plate [0087] 95. lock plate mandrel release opening [0088] 100. sleeve [0089] 110. handle [0090] 120. knob [0091] 130. knob unlock direction of movement [0092] 140. knob advancement direction of movement [0093] 150. knob implant release direction of movement [0094] 160. implant removal direction of movement for prong disengagement [0095] 170. prong twist angle [0096] 180. mandrel [0097] 190. mandrel head [0098] 200. proximal bone [0099] 210. distal bone [0100] 220. distal bone hole [0101] 230. proximal bone hole [0102] 300. internal locking prongs [0103] 310. internal prong locking tabs [0104] 320. external locking prongs [0105] 330. external prong locking tabs [0106] 340. mandrel for internal locking prongs [0107] 350. mandrel for external locking prongs [0108] 360. K-wire for alignment, creation of a pilot hole and fixating adjacent joints. [0109] 370. Drill bit [0110] 380. Drill stop [0111] 390. Drill bit handle [0112] 400. Direction of drill rotation [0113] 410. Removable lock pin and ring [0114] 420. Direction of knob rotation to release mandrel [0115] 430 Direction of advance of K-wire to treat adjacent joints [0116] 440 Lock plate integral to the IFS

DETAILED DESCRIPTION

[0117] The embodiments of the subject invention includes a tubular implant with a plurality of locking prongs 50, expanding and implant shortening bone locking bulges 40, fenestrations in its body, and a lumen 80 for bone ingrowth and instrument 110 operation.

[0118] The implant can be fabricated of any cross section not limited to round, square, hexagonal or triangular that can be formed with a lumen 80. The lumen 80 forms a hollow core to allow bone to form through the implant and bridge the bone segments it fixates.

[0119] This lumen 80 further receives the instrument mandrel 180 to extend the implant's length and constrain the implant at its greatest length and minimum bulge 45 diameter. The mandrel has at least one section that is square, rectangular, hexagonal, triangular or other shape other than round. The mandrel 180, lock plate 90 and implant push plate 60 interlock to hold the implant extended, as illustrated in FIG. 6b. When the mandrel 180 is turned, it aligns with the lock plate slot 95 removing the implant's constraint and allowing the implant to shorten and the bulges 40 to be in their extended state. The lock plate (440) can be integral to the body and contained within the lumen (80) in an alternate embodiment where the lock plate is not removable.

[0120] The prongs 50 and bulge 40 lock into bone to resist implant rotation and pull out and pull the bones together to create compression. If implant loosening occurs the bulges 40 will continue to expand further shortening the implant and causing it to keep pulling the bones together.

[0121] The constrained implant state of FIG. 1a and the unconstrained state of FIG. 1b illustrate the shape change that occurs to the implant when release with the instrument. In use, the implant is held within an instrument 110 with an advance and release knob 120 as shown in FIG. 2a. The instrument has a sleeve 100 that constrains the implant and protects it from inadvertent release and resist rotation of the implant through interlocking features with the prongs 50 and lock plate 90. Alternatively, sleeve 100 can be omitted and a separate component protective end cap can be placed over the implant and instrument to constrain and protect the implant. When the lock knob 120 is advanced and turned within the instrument 110, the implant is released and the bulges 40 extend as shown in FIG. 2b.

[0122] Implantation into a drill hole 230 in bone 200 is illustrated in FIG. 3a, where the implant is positioned for placement, and in FIG. 3b, where the implant is advanced until it is fully within bone and the lock plate 90 is in contact with the end face of the bone. Once the implant is in position, the lock knob 120 is turned in direction 130 to release the lock knob 120 so that it can be advanced in direction 140 with the implant as shown in FIG. 4a and FIG. 4b. Once advanced the lock knob 120 is turned in direction 150, and the implant is released as shown in FIG. 4c. An alternate embodiment exist that does not require the implant to be advanced out of the instrument 110 and only requires the lock knob 120 to be turned to release the implant. This embodiment uses the protective end cap.

[0123] The instrument is then withdrawn from the implant so that a first end of the implant is within bone 200 and the second end extends beyond bone as shown in FIG. 5a. The second bone 210 is then placed so that its drill hole 220 covers the second end of the implant as shown in FIG. 5b. Once the bones are approximated, the lock plate 90 is pulled from the implant at the bone interface allowing bone to bone contact to occur as shown in FIG. 5c.

[0124] The implant prongs 50 have a twist along their central axis so that they are at an angle 170 with the body of the implant. This twist allows the implant to be rotated and pulled from bone as shown in FIG. 6a, if removal is required. When rotated counter clockwise (direction 160), the prongs 50 deflect towards the implant centerline and disengage bone allowing a twisting and pulling motion to remove the implant.

[0125] Alternate embodiments of the mandrel 340 can be used with an internal locking prongs 300 with tabs 310 to hold the implant and extend its length as shown in FIGS. 7a-7c. A second alternate embodiment of the mandrel 350 and external locking prongs 320 with tabs 330 can be used as shown in FIGS. 8a-8c.

[0126] The invention and its various embodiments are unique in that the implant first locks into a first bone and a second bone and then, when the mandrel 190 releases through the lock plate 90, the bulge 40 expands and shortens the implant. With both ends locked into bone, the expansion of the bulge 40 pulls together and compresses the bone at the healing interface. The implant is self-adjusting in that, if it loosens, the bulge 40 further expands, the implant shortens, and the bone is again pulled together and held in contact.

[0127] The action of the implant minimizes or eliminates any distance bone must grow to fuse the two bone segments. This lack of a gap between the bones further minimizes the possibility of soft tissue migrating between the bone segments and delaying healing. It is further believed that the interfacial pressure created may stimulate bone healing.

[0128] In other embodiments of the present invention, the implant can be designed to differently change in length, such as to extend to distract two bones. For instance, embodiments of the subject invention includes a tubular implant with a plurality of locking prongs, implant lengthening bone locking extenders, fenestrations in its body, and a lumen for bone ingrowth and instrument operation. Such implants can be utilized in applications in which the two bones are held and maintained in distraction.

[0129] This pre-sterilized combination instruments and implant can be packaged with a drill bit and wires so that the medical procedure kit fully supports the surgical technique. Hospital costs savings are achieved because there is no hospital cleaning or sterilization required and the patients and hospital benefit from fewer infections and patient complications.

OPERATION OF THE INVENTION

[0130] The implant embodiments are uniquely suited for fixation of materials that have a tendency to benefit from compression or shrink and withdraw so that the fixated structures lose contact. Without limiting the scope of the invention the illustrated embodiments are used for bone fixation. In bone surgery fragments, separated segments and segments requiring fixation are pulled together by the implant because it is inserted so that one end is in a first bone segment and the other end is in the second bone segment. This method of surgical use is common to bone fixation devices.

[0131] The shape changing implant, of the embodiments of the subject invention, exert bone compression force that is not temperature dependent. This provides tremendous advantage for the surgeon and patient over prior art nitinol shape changing implants.

[0132] Temperature independence solves problems with the prior art nitinol staples because the embodiments of the subject invention apply consistent force prior, during and following implantation. Body temperature implants' force changes as the operative wound warms from near room temperature to body temperature. This force increase occurs after the wound is closed and without the knowledge of the surgeon can create fracture or deformity.

[0133] During surgical use the surgeon inserts one end of the implant into a first bone so that the end, prongs and bulge are fully contained within the first bone. The instrument holding the implant elongated is operated to release the implant. When released the bulge expands pulling the implant deeper into bone until the implant lock plate resist the pulling forces of the implant. The second implant end is then positioned in a second bone and this bone is pushed so that the implant is fully contained within the two bones. Once the bones are in apposition the lock plate is pulled and the two bones are held in contact and under compression by the shape changing elements of the implant. Often treatment of the joints adjacent to where the implant is placed require temporary fixation. Surgeons commonly use a sharp tipped stiff wire. The implant uniquely allows a surgeon to advance a wire through the lumen of the implant into an adjacent joint.

[0134] The operation of embodiments can occur with or without the addition of heat. The preferred embodiment requires no heat other than that of the environment, room temperature. Alternate embodiments can be fabricated so that they change shape at body temperature or with higher temperatures caused by heating strategies such as conduction, induction or resistive heating.

[0135] First, the operation of the preferred embodiment is independent of temperature in the range of temperatures expected in clinical use and the use of nitinol. Thus tight control of the material's crystalline structure transition temperature is not required. Furthermore, the temperatures are set so that the material is always in its strong and high temperature austenitic form. Thus as long as the austenitic finish temperature is above 20 C. then it will be stable in the operating theater and patient's body. So fine chemistry control and post heat treatment to shift transition temperature is not required.

[0136] A surgical method for using the implant is illustrated in FIGS. 9-16. In the illustrated procedures, the implant within its instrument, the bone cutting instrument, and the wire have been removed from the sterile package. FIGS. 9-16 illustrate steps in the procedure.

[0137] As shown in FIG. 9, an alignment K-wire is used to create a pilot hole along the centerline of the bone.

[0138] As shown in FIG. 10, a cutting instrument with depth stop is used to create a drill hole along the bone centerline of the distal bone.

[0139] As shown in FIG. 11, a cutting instrument with depth stop is used to create a drill hole along the bone centerline of the proximal bone.

[0140] As shown in FIG. 12, the intermedullary fixation scaffold is inserted in the proximal bone drill hole.

[0141] As shown in FIG. 13, the intermedullary fixation scaffold is unlocked and knob rotated to release the intermedullary fixation scaffold.

[0142] As shown in FIG. 14, the distal end of the intermedullary fixation scaffold is positioned for insertion into the distal bone drill hole.

[0143] As shown in FIG. 15, the distal and proximal bones are pushed together so that both bones contact the lock plate proceeding the lock plate removal.

[0144] As shown in FIG. 16, k-wire is inserted through an adjacent joint for its treatment, through the intermedullary fixation scaffold and if further advanced through a second adjacent joint.

CONCLUSIONS AND SCOPE

[0145] The embodiments illustrated in this application are a significant advancement over the prior art fixation implants such as wires, screws, expanding nitinol implants and multi-component implants in: (1) the method of operation of the implant and its high strength, (2) the method of insertion of the implant, (3) its compressive and expansion force temperature independence, (4) its efficient implant retention and delivery system, (5) its compatibility with reusable or single use product configuration where all required instruments are sterile packaged with the implant, (6) its efficient and cost effective manufacturing methods, and (7) its minimization of the steps required to place the device. These advantages are important to musculoskeletal surgery as well as industrial applications.

[0146] Although the description above contains many specificities, these should not be construed as limiting the scope of the embodiments but as merely providing illustrations of some of the presently preferred embodiments. Thus the scope of the embodiment should be determined by the appended claims and their legal equivalents, rather than by the examples given.