WO2014099619A1

WO2014099619A1 - Method and apparatus for pre-forming a high tibial osteotomy

Info

Publication number: WO2014099619A1
Application number: PCT/US2013/074723
Authority: WO
Inventors: William Maxson; Gautam Gupta
Original assignee: Biomet Sports Medicine, Llc
Priority date: 2012-12-19
Filing date: 2013-12-12
Publication date: 2014-06-26
Also published as: EP2934356B1; US9700414B2; US20140172116A1; US8920512B2; EP2934356A1; US20150148904A1

Abstract

An osteotomy implant including a porous portion, a solid portion, and a hinge portion. The porous portion includes a first part and a second part that defines a clearance therebetween. A solid portion abuts the porous portion. A hinge portion of the solid portion is coupled to the first part and the second part. The hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

Description

METHOD AND APPARATUS FOR PRE-FORMING A HIGH TIBIAL

OSTEOTOMY

FIELD

[0001] The present disclosure relates to a method and apparatus pre-forming a high tibial osteotomy.

BACKGROUND

[0002] This section provides background information related to the present disclosure which is not necessarily prior art.

[0003] Various knee osteotomies are performed to adjust or change the orientation of the tibia to correct various abnormalities caused by birth defects, trauma, or disease. High tibial osteotomies include open-wedge and closed-wedge osteotomies. Various implants designed to fill osteotomies exist. Some are modeled after a patient's specific anatomy, which increases the cost of the implant and complexity of production. Therefore, a simplified and cost- effective osteotomy implant that can be adjusted to fit a patient's anatomy would be desirable. SUMMARY

[0004] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0005] The present teachings provide for an osteotomy implant including a porous portion, a solid portion, and a hinge portion. The porous portion includes a first part and a second part that defines a clearance therebetween. A solid portion abuts the porous portion. A hinge portion of the solid portion is coupled to the first part and the second part. The hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

[0006] The present teachings also provide for an osteotomy implant including a porous metallic portion, a solid metallic portion, and a metallic hinge portion. The porous metallic portion includes a first part spaced apart from a second part. The solid metallic portion is integral with the porous metallic portion. The metallic hinge portion of the solid metallic portion is one of aligned with or between the first part and the second part. The hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

[0007] The present teachings also provide for an osteotomy implant including a generally "U" shaped loadbearing porous portion including a first part and a second part. The first part includes a first inner surface that opposes a second inner surface of the second part. A solid portion is coupled to both a first outer surface of the first part and a second outer surface of the second part. The first outer surface is opposite to the first inner surface and the second outer surface is opposite to the second inner surface. A flexible hinge portion is included with the solid portion. The implant is bendable at the flexible hinge portion to compress or expand the implant. The flexible hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

[0008] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

DRAWINGS

[0009] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0010] Figure 1 illustrates an osteotomy implant according to the present teachings for implantation in an osteotomy site of a tibia bone;

[0011] Figure 2 is a perspective view of the implant of Figure 1 ;

[0012] Figure 3 is a perspective view of another osteotomy implant according to the present teachings;

[0013] Figure 4 is a perspective view of an additional osteotomy implant in accordance with the present teachings;

[0014] Figure 5 is a top view of yet another osteotomy implant according to the present teachings; [0015] Figure 6 is a top view of still another osteotomy implant according to the present teachings; and

[0016] Figure 7 is a top view of an additional osteotomy implant according to the present teachings.

[0017] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.

DETAILED DESCRIPTION

[0018] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0019] With initial reference to Figures 1 and 2, an osteotomy implant according to the present teachings is generally illustrated at reference numeral 10. As illustrated, the osteotomy implant 10 is for implantation at osteotomy site 12 of tibia 14. Femur 16 is also illustrated. The implant 10 can also be implanted at an osteotomy site in the femur 16, such as during a distal femoral osteotomy procedure.

[0020] The osteotomy implant 10 generally includes a porous portion 20 and a solid portion 22. The porous portion 20 generally includes a first part 24 and a second part 26, which define a clearance or gap 28 therebetween. Both the first part 24 and the second part 26 include an inner surface 30 and an outer surface 32, which is opposite to the inner surface 30. The first part 24 and the second part 26 are arranged such that the inner surface 30 of the first part 24 faces and is opposite to the inner surface 30 of the second part 26. Each of the first part 24 and the second part 26 further include an upper or superior surface 34, which is opposite to an under or inferior surface 36. The solid portion 22 includes an inner surface 38, which is opposite to an outer surface 40. The solid portion 22 extends across the outer surface 32 of each of the first part 24 and the second part 26 of the porous portion 20, and thus extends across the gap 28. The solid portion 22 includes a hinge 42, such as a living hinge, opposite to the gap 28.

[0021] The implant 10 can be made of any suitable biocompatible material sufficient to bear loads on the tibia 14 at the osteotomy site 12. For example, the implant 10 can be made out of a suitable metallic, such as titanium including commercially pure (CP) titanium or Grade 5 titanium alloy (Ti6AI4V). An example of a suitable porous titanium construct that the implant can be made from is Regenerex^® by Biomet of Warsaw, Indiana. Any suitable cobalt chrome based alloy may also be used. Both the porous portion 20 and the solid portion 22 can be made of the same material. The porous portion 20 can be made from any suitable implantable plastic, such as PEEK (polyether ether ketone) or PEKK (polyether ketone ketone). For example, the porous portion 20 can include ProOsteon^® by Biomet of Warsaw, Indiana.

[0022] The implant 10 can be manufactured in any suitable manner. For example, the porous portion 20 and the solid portion 22 can be individually manufactured and then subsequently coupled or joined together using any suitable coupling process. Other manufacturing processes that are suitable include electron beam melting or any suitable additive manufacturing process, such as a suitable additive metal fabrication technique. Using laser sintering, for example, the entire implant 10 can be manufactured or printed together, such that the porous portion 20 and the solid portion 22 are integrally formed and the implant 10 is monolithic. The porous portion 20 can be formed in any suitable manner that will provide for pores into which bone growth may occur in order to further secure the implant 10 at the osteotomy site 12. The porous portion 20 is a generally "U" shaped, load-bearing portion able to withstand loads upon the tibia 14. Upon being inserted into the osteotomy site 12, the implant 10 will be retained within the osteotomy site 12 through friction between the tibia 14 and the porous portion 20. The solid portion 22 further increases the compression strength of the implant 10 and prevents tissue from growing into the porous portion 20 from outside of the osteotomy site 12. The porous portion 22 may include ribs 44 to further increase the compression strength of the implant 10. The ribs 44 are structural, load-bearing ribs that are not porous.

[0023] Implantation of the implant 10 at the osteotomy site 12 will now be described. The implant 10 selected for implantation can be chosen from a plurality of implants 10 having a similar overall configuration, but having different general sizes to facilitate customization. For example, a plurality of implants 10 having different superior-inferior heights and medial-lateral widths can be provided and selected based on dimensions of the osteotomy size 12. The width of the implant 10 is first compared to the width of the osteotomy site 12 in the anterior to the posterior direction. The width of the implant 10 is generally considered with respect to the distance between the first part 24 and the second part 26 of the porous portion 20. If the width of the implant 10 is wider than the width of the osteotomy site 12, then the implant 10 can be compressed in order to decrease the width. If the width of the implant 10 is narrower than the width of the osteotomy site 12, then the implant 10 can be expanded in order to increase its width.

[0024] The implant 10 can be compressed (closed) or expanded (opened) either manually or using a suitable tool. The material of the solid portion 22 is rigid enough to maintain structural integrity of the implant 10, but flexible enough to permit the implant 10 to be compressed in this manner. As the first part 24 and the second part 26 are moved together, the gap 28 therebetween will become smaller. As the first part 24 and the second part 26 are moved apart, the gap 28 therebetween will become larger. Specifically, implant 10 pivots generally at the hinge 42, which can be configured in any suitable manner to facilitate bending of the solid portion 22, such as with a thinned portion, a notched portion, or any weakened portion. The first part 24 and the second part 26 can be compressed or expanded to any suitable position, such as between a first configuration and a second configuration, thus providing the implant 10 with a near infinite number of medial-lateral widths. The rigidity of the solid portion 22 will maintain the implant 10 in the compressed or expanded position to provide the implant 10 with a desired medial-lateral width to fit the osteotomy site 12. As the first part 24 and the second part 26 are moved, the solid portion 22 bends at the hinge 42. The implant 10 is retained within the osteotomy site 12 due to friction between the portion of the tibia 14 at the osteotomy site 12 and the porous portion 20. The implant 10 will be further retained within the osteotomy site 12 by bone ingrowth into the porous portion 20. The implant 10 can also be retained within the osteotomy site 12 with any suitable retention device or feature, such as a suitable locking plate.

[0025] With additional reference to Figure 3, another osteotomy implant according to the present teachings is illustrated at reference numeral 50. The implant 50 is similar to the implant 10, and thus similar features are designated with similar reference numbers, and the description of these similar features set forth above in the description of the implant 10 also applies to the implant 50. The implant 50 can also be formed of the same material as the implant 10, and manufactured in the same manner. Unlike the implant 10, the solid portion 22 of the implant 50 is at the inner surface 30 of the porous portion 20. Providing the solid portion 22 at the inner surface 30 will typically increase the overall structural integrity of the implant 50.

[0026] Another osteotomy implant according to the present teachings is illustrated in Figure 4 at reference numeral 60. The implant 60 is similar to the implant 10, and thus similar features are designated with similar reference numbers, and the description of these similar features set forth above in the description of the implant 10 also applies to the implant 60. The implant 60 can also be formed of the same material as the implant 10, and manufactured in the same manner.

[0027] The porous portion 20 of the implant 60 is divided into a plurality of porous parts 20A through 20F. Each of the porous parts 20A-20F is surrounded by the solid portion 22. Between adjacent ones of the porous parts 20A-20F, the solid portion 22 includes the hinge 42, and thus a plurality of hinges 42A-42E are provided to link together the plurality of porous parts 20A- 20F. Any suitable number of porous portions 20 can be included with the implant 60 depending on the size of the osteotomy site 12. To optimize fit between the implant 60 and the osteotomy site 12, the implant 60 can be flexed or compressed either inward or outward at any of the hinges 42A-42E, allowing the implant 60 to be flexed or compressed to nearly an infinite number of positions. The porous portions 20 define therebetween a plurality of clearances or gaps 28 that allow the implant 60 to be flexed inward and outward at the hinges 42. The width of the clearances or gaps 28 can be set to limit the amount of flex between the porous portions 20. The porous portions 20A-20F are exposed at the upper surfaces 34 and the under surfaces 36 thereof in order to permit bone growth therein, which further secures the implant 60 at the osteotomy site 12. The thickness of the hinge 42 can be adjusted to control the flexibility of the hinge 42. [0028] Another osteotomy implant according to the present teachings is illustrated in Figure 5 at reference numeral 70. The implant 70 is similar to the implant 10, for example, and thus like features are illustrated and described using similar reference numbers. The implant 70 can also be manufactured in the same way described above with respect to the implant 10. Unlike the implant 10, the implant 70 includes a hinge 42 with a ball 42F and a socket 42G. The ball 42A extends from the first solid portion 22A of the first part 24 of the porous portion 20. The socket 42G is defined within second solid portion 22B of the second part 26 of the porous portion 20. The clearance or gap 28 is defined between the first part 24 and the second part 26 of the porous portion 20. The ball and socket hinge 42F/42G can be formed in any suitable manner, such as using electron beam melting or direct metal laser sintering, which allows the ball and socket hinge 42F/42G to be "printed" together with the rest of the implant 70, such as by direct metal laser sintering or any other additive metal fabrication technique. Other suitable hinges include, for example, a barrel hinge and a butt hinge.

[0029] The ball and socket hinge 42F/42G facilitates movement of the first part 24 and the second part 26 of the porous portion 20 together or apart in order to decrease or increase the medial-lateral width of the implant to correspond to the implant site 12. When set at the desired medial-lateral width, the ball and socket hinge 42F/42G will retain the implant 70 at the set width in any suitable manner, such as by friction between the ball 42F and the socket 42G, or with any suitable locking device. Although the implant 70 is not illustrated with the first solid portion 22A extending entirely across the outer surface 32 of each of the first part 24 of the porous portion 20, the first solid portion 22A can be lengthened to extend entirely across the outer surface 32 of the first part 24. Similarly, the second solid portion 22B can be lengthened so as to extend across the entire outer surface 32 of the second part 26 of the porous portion 20. The ball 42F and the socket 42G can be provided in place of the hinge 42 of any one of the implants 10, 50, or 60, as well as the implants 80 and 90 described herein.

[0030] Yet another osteotomy implant according to the present teachings is illustrated in Figure 6 at reference numeral 80. The implant 80 is similar to the implant 10 of Figure 2, and thus like reference numerals are used to illustrate the similar features. The description of these like features set forth in the description of the implant 10 also applies to the implant 80. The implant 80 can be manufactured in the same manner set forth above with respect to the implant 10. Unlike the implant 10, the implant 80 includes an adjustment member, such as a fastener 82, extending through an aperture 84 defined in the solid portion 22. The fastener 82 also extends through portions of the porous portion 20 from the second part 26 to the first part 24, and thus spans the clearance or gap 28 therebetween. The fastener 82 can be threaded directly into the first part 24, or the first part 24 can include a threaded receptacle 86 to cooperate with the fastener 82. The fastener 82 facilitates compression and expansion of the first part 24 and the second part 26 of the porous portion 20. Specifically, as the fastener 82 is rotated in a first direction, such as with a suitable device, the fastener 82 will draw the first and second parts 24 and 26 together. As the fastener 82 is rotated in a second direction, the fastener 82 will push the first and second parts 24 and 26 apart. This will cause the solid portion 22 to generally bend about the hinge 42. The fastener 82 can be provided with any one of the implants 10, 50, 60, or 70.

[0031] Figure 7 illustrates another osteotomy implant according to the present teachings at reference numeral 90. The implant 90 is similar to the implant 10, and thus features in common with the implant 10 are illustrated using common reference numbers. The solid portion 22 defines an aperture 92 proximate to hinge 42 of the implant 90. Seated within and extending through the aperture 92 is an adjustment member, such as a fastener 94. The fastener 94 is threaded into a nut 96 seated between the first part 24 and the second part 26 of the porous portion 20. Specifically, the nut 96 abuts the inner surface 30 of each of the first and second parts 24 and 26. As the screw is rotated with a suitable device, the screw will further cooperate with threads of the nut 96 to draw the nut 96 toward the solid portion 22, thereby causing the nut 96 to apply pressure to each of the inner surfaces 30 of the first and second parts 24 and 26 to force the first part 24 and the second part 26 apart, and thus increase the width of the implant 90 to fit a wider osteotomy site 12 from a first dimension to a second greater dimension. [0032] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

Claims

CLAIMS What is claimed is:

1 . An osteotomy implant comprising:

a porous portion including a first part and a second part that defines a clearance therebetween;

a solid portion abutting the porous portion; and

a hinge portion of the solid portion coupled to the first part and the second part;

wherein the hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

2. The osteotomy implant of Claim 1 , wherein the porous portion includes at least one of a metallic, PEEK, or PEKK.

3. The osteotomy implant of Claim 1 , wherein the porous portion includes a porous upper surface and a porous lower surface configured to receive bone ingrowth.

4. The osteotomy implant of Claim 3, wherein the solid portion is coupled to an outer surface of the porous portion, the osteotomy implant formed by additive manufacturing.

5. The osteotomy implant of Claim 4, wherein the solid portion is integral with the outer surface of the porous portion and is load bearing.

6. The osteotomy implant of Claim 1 , further comprising a plurality of solid, spaced apart, load bearing ribs with the porous portion therebetween.

7. The osteotomy implant of Claim 1 , wherein the solid portion includes at least one of a metallic, PEEK, or PEKK.

8. The osteotomy implant of Claim 1 , wherein the solid portion surrounds the first part and the second part of the porous portion.

9. The osteotomy implant of Claim 1 , wherein the implant is monolithic.

10. The osteotomy implant of Claim 1 , wherein the hinge portion includes one of a living hinge, ball in cooperation with a socket, barrel hinge, or butt hinge.

1 1 . The osteotomy implant of Claim 1 , further comprising an adjustment member configured to change the implant from the first configuration to the second configuration.

12. The osteotomy implant of Claim 1 1 , wherein the adjustment member includes a fastener extending from the first part to the second part across the clearance defined between the first part and the second part, rotation of the fastener in a first direction draws the first part and the second part together, rotation of the fastener in a second direction pushes the first part and the second part apart.

13. The osteotomy implant of Claim 1 , wherein the solid portion defines an aperture proximate to the hinge portion configured to receive an adjustment member coupled to a wedge-shaped nut between the first part and the second part of the porous portion such that as the fastener is tightened, the first part and the second part are moved apart by the nut.

14. An osteotomy implant comprising:

a porous metallic portion including a first part spaced apart from a second part;

a solid metallic portion integral with the porous metallic portion; and a metallic hinge portion of the solid metallic portion one of aligned with or between the first part and the second part; wherein the hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

15. The osteotomy implant of Claim 14, further comprising an adjustment member configured to change the implant from the first configuration to the second configuration.

16. The osteotomy implant of Claim 14, further comprising a fastener between the first part of the porous metallic portion and the second part of the porous metallic portion, rotation of the screw in a first direction draws the first and the second parts together, and rotation of the screw in a second direction opposite to the first direction pushes the first and the second parts apart.

17. The osteotomy implant of Claim 14, wherein the solid metallic portion is integral with an outer surface of the porous metallic portion.

18. An osteotomy implant comprising:

a generally "U" shaped loadbearing porous portion including a first part and a second part, the first part includes a first inner surface that opposes a second inner surface of the second part;

a solid portion coupled to both a first outer surface of the first part and a second outer surface of the second part, the first outer surface is opposite to the first inner surface and the second outer surface is opposite to the second inner surface; and

a flexible hinge portion of the solid portion;

wherein the implant is bendable at the flexible hinge portion to compress or expand the implant; and

wherein the flexible hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

19. The osteotomy implant of Claim 18, wherein both the porous portion and the solid portion include at least one of a metallic, PEEK, or PEKK.

20. The osteotomy implant of Claim 18, wherein the first part and the second part of the porous portion define a clearance therebetween that decreases in size when the implant is compressed, and increases in size when the implant is expanded.