Surgical implantation of cartilage repair unit

• US 5,632,745 A
• Filed: 02/07/1995
• Issued: 05/27/1997
• Est. Priority Date: 02/07/1995
• Status: Expired due to Term

• Current Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Original Assignee: R&D Biologicals Incorporated
• Inventors: Schwartz, Robert E.
• Primary Examiner(s): Tucker, Guy V.
• Application Number:
  US08/384,849
• Time in Patent Office: 840 Days
• Field of Search: 606/75, 606/72, 606/60, 606/77, 606/76, 606/80, 606/88, 606/96, 606/99, 606/100, 606/104, 606/213, 606/215, 606/219, 623/16, 623/20
• US Class Current: 606/75
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4618 of cartilage
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/3028 polyhedral different from parallelepipedal and pyramidal
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30367 with additional means for preventing said rotation
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30487 Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30733 : Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30751 : for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30766 : Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30808 : parallel
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30881 : Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/227 : Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body

Abstract

A method of surgically implanting into a site with cancellous bone a bio-absorbable cartilage repair system including an assembly. The method includes the steps of partially preparing the site to receive the assembly by removing at least a portion of the damaged or destroyed articular cartilage, and then removably fixing the forward tip of a guide wire in the cancellous bone under the removed articular cartilage. The guide wire is then utilized to further prepare the site to receive the assembly by drilling and countersinking the subchondral cancellous bone and to seat the assembly into the drilled and countersunk subchondral cancellous bone until the assembly is flush with the surrounding articular surface. The guide wire is then removed.

Claims

1. A method of surgically implanting, into a site of damaged or destroyed articular cartilage and cancellous bone, a bio-absorbable cartilage repair system including an assembly, the method comprising the steps of:

(A) partially preparing the site to receive the assembly by removing at least a portion of the damaged or destroyed articular cartilage;

(B) removably fixing the forward tip of a guide wire in the cancellous bone under the removed articular cartilage;

(C) utilizing the guide wire to further prepare the site to receive the assembly by drilling and countersinking the subchondral cancellous bone;

(D) utilizing the guide wire to seat the assembly into the and countersunk subchondral cancellous bone until the assembly is flush with the surrounding articular surface; and

(E) removing the guide wire.

2. The method of claim 1 wherein in step A the site is partially prepared using a cannulated punch.

3. The method of claim 2 wherein the punch is polygonal.

4. The method of claim 2 wherein in step B the guide wire is inserted through the cannula of the punch after removal of a portion of the damaged or destroyed articular cartilage.

5. The method of claim 1 wherein in step C a cannulated drill/countersink is passed over the guide wire prior to drilling and countersinking.

6. The method of claim 1 wherein in step D the assembly is passed over the guide wire prior to seating.

7. A method of surgically implanting, into a site of damaged or destroyed articular cartilage and cancellous bone, a bio-absorbable cartilage repair system including an assembly adapted to regenerate damaged or destroyed articular cartilage on the surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, the assembly including:

(i) a bio-absorbable polygonal delivery unit configured and dimensioned to be mounted in both the removed area and the adjacent healthy area of bone; and

(ii) a porous bio-absorbable insert supported by and in the delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

the method comprising the steps of;

(A) partially preparing the site to receive the assembly by removing at least a portion of the damaged or destroyed articular cartilage;

(B) removably fixing the forward tip of a guide wire in the cancellous bone under the removed articular cartilage;

(C) utilizing the guide wire to further prepare the site to receive the assembly by countersinking the subchondral cancellous bone;

(D) utilizing the guide wire to seat the assembly into the countersunk subchondral cancellous bone until the assembly is flush with the surrounding articular surface; and

(E) removing the guide wire.

8. A method of surgically implanting a bio-absorbable cartilage repair system having an assembly for regenerating damaged or destroyed articular cartilage on the surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, the assembly including:

(i) a bio-absorbable polygonal delivery unit configured and dimensioned to be mounted in both the removed area and the adjacent healthy area of bone; and

(ii) a porous bio-absorbable insert supported by and in the delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

the method comprising the steps of;

(A) removing at least a portion of the damaged or destroyed area with a cannulated polygonal punch;

(B) inserting a guide wire through the cannula of the punch and then removably fixing the forward tip thereof in the cancellous bone;

(C) removing the punch from the guide wire;

(D) passing a cannulated countersink over the guide wire and then countersinking the subchondral cancellous bone;

(E) removing the drill/countersink from the guide wire;

(F) passing the assembly over the guide wire and then into the drilled and countersunk subchondral cancellous bone until the assembly is flush with the surrounding articular surface; and

(G) removing the guide wire.

9. The method of claim 8 including the preliminary step of inserting an arthroscope adjacent the area of damaged or destroyed articular cartilage to enable viewing of the area.

10. The method of claim 8 including in step B impacting the punch with a mallet until the punch reaches a depth of about 3-4 mm into the articular cartilage and subchondral cancellous bone.

11. The method of claim 8 wherein the guide wire has a self-tapping threaded forward tip and is rotated by a power drill in step D.

12. The method of claim 8 including in step F passing a cannulated inserter and then a cannulated impactor over the guide wire after the assembly and then using the impactor to drive the inserter by itself along the guide wire and against the assembly to seat the assembly in the countersunk subchondral cancellous bone, followed by removing the inserter and impactor from the guide wire.

13. A method of surgically implanting into a site with damaged or destroyed articular cartilage and cancellous bone a bio-absorbable cartilage repair system including at least first and second assemblies, the method comprising the steps of:

(A) proving a spacer for use in spacing apart two guide wires during surgical implantation of the second guide wire a fixed distance from the implanted first guide wire;

(B) partially preparing the site to receive the first assembly by removing at least a portion of the damaged or destroyed articular cartilage;

(C) removably fixing the forward tip of a first guide wire in the cancellous bone under the removed articular cartilage;

(D) utilizing the spacer and the first guide wire to removably fix the forward tip of the second wire guide in the cancellous bone a fixed distance from the first guide wire;

(E) utilizing the second guide wire to partially prepare the site to receive the second assembly by removing another portion of the damaged or destroyed articular cartilage;

(F) utilizing the first and second guide wires to further prepare the site to receive the assembly by countersinking the subchondral cancellous bone;

(G) utilizing the first and second guide wires to seat the first and second assemblies, respectively, into the drilled and countersunk subchondral cancellous bone until the assemblies are flush with the surrounding articular surface; and

(H) removing the guide wires.

14. A method of surgically implanting into a site with damaged or destroyed articular cartilage and cancellous bone a bio-absorbable cartilage repair system including at least first and second assemblies, the method comprising the steps of:

(A) proving a spacer for use in spacing apart two guide wires during surgical implantation of the second guide wire a fixed distance from the implanted first guide wire;

(B) partially preparing the site to receive the first assembly by removing at least a portion of the damaged or destroyed articular cartilage;

(C) removably fixing the forward tip of a first guide wire in the cancellous bone under the removed articular cartilage;

(D) utilizing the spacer and the first guide wire to removably fix the forward tip of the second wire guide in the cancellous bone a fixed distance from the first guide wire;

(E) utilizing the second guide wire to partially prepare the site to receive the second assembly by removing another portion of the damaged or destroyed articular cartilage;

(F) utilizing the first and second guide wires to further prepare the site to receive the assembly by and countersinking the subchondral cancellous bone;

(G) utilizing the first and second guide wires to seat the first and second assemblies, respectively, into the countersunk subchondral cancellous bone until the assemblies are flush with the surrounding articular surface; and

(H) removing the guide wires;

the spacer including;

(i) a first cannulated polygonal member having an axis X, N sides, a maximum width W and a length L; and

(ii) a second cannulated polygonal member having an axis x, n sides, a maximum width w, and a length l, where N, W and L are not less than n, w and l, respectively, and axes X and x are substantially parallel;

one side of said first cannulated member and one side of said second cannulated member being rigidly joined, and one end of said first cannulated member and one end of said second cannulated member being disposed in the same plane, and the opposite end of said first cannulated member and the opposite end of said second cannulated member being disposed in spaced apart parallel planes.

15. The method of claim 14 including the steps of:

(i) passing the first cannulated member of the spacer over the first guide wire with the second cannulated member of the spacer disposed over another portion of the damaged or destroyed articular cartilage area;

(ii) inserting a second guide wire through the cannula of the second cannulated member of the spacer and then removably fixing the forward tip thereof in the cancellous bone; and

(iii) removing the spacer from both guide wires.

16. A method of surgically implanting a bio-absorbable cartilage repair system, the method comprising the steps of:

(A) providing at least two assemblies for regenerating damaged or destroyed articular cartilage on the surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, each assembly including;

(i) a bio-absorbable polygonal delivery unit configured and dimensioned to be mounted in both the removed area and the adjacent healthy area of bone; and

(ii) a porous bio-absorbable insert supported by and in the delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

(B) providing a spacer for use in spacing apart two guide wires during surgical implantation of the second guide wire a fixed distance from the implanted first guide wire, the spacer including

(i) a first cannulated polygonal member having an axis X, N sides, a maximum width W and a length L; and

(ii) a second cannulated polygonal member having an axis x, n sides, a maximum width w, and a length l, where N and W are at least equal to n and w, L exceeds l, and axes X and x are substantially parallel;

one side of said first member and one side of said second member being rigidly joined, and one end of said first member and one end of said second member being disposed in the same plane, and the opposite end of said first member and the opposite end of said second member being disposed in spaced apart parallel planes;

(C) removing a portion of the damaged or destroyed area with a cannulated polygonal punch;

(D) inserting a first guide wire through the cannula of the punch and then removably fixing the forward tip thereof in the cancellous bone;

(D) removing the punch from the first guide wire;

(E) passing the first polygonal member of the spacer over the first guide wire with the second polygonal member of the spacer disposed over another portion of the damaged or destroyed area;

(F) inserting a second guide wire through the cannula of the second polygonal member of the spacer and then removably fixing the forward tip thereof in the cancellous bone;

(G) removing the spacer from both guide wires;

(H) passing a cannulated polygonal punch over the second guide wire and then removing the another portion of the damaged or destroyed area;

(I) passing a cannulated countersink over each of the guide wires and then countersinking the subchondral cancellous bone;

(J) removing the countersink from each of the guide wires;

(K) moving each of the assemblies over its respective guide wires and then into the countersunk subchondral cancellous bone until each assembly is flush with the surrounding articular surface; and

(L) removing the guide wires.

17. The method of claim 16 including the preliminary step of inserting an arthroscope adjacent the area of damaged or destroyed articular cartilage to enable viewing of the area.

18. The method of claim 16 including in step C impacting the punch with a mallet until the punch reaches a depth of about 3-4 mm into the articular cartilage and subchondral cancellous bone.

19. The method of claim 16 wherein the guide wire has a self-tapping threaded forward tip and is rotated by a power drill in step D.

20. The method of claim 16 including in step K passing a cannulated inserter and then a cannulated impactor over the guide wire after the assembly and then using the impactor to drive the inserter by itself along the guide wire and against the assembly to seat the assembly in the countersunk subchondral cancellous bone, followed by removing the inserter and impactor from the guide wire.

21. The method of claim 16 wherein in step K the assemblies are moved so that they are in the countersunk subchondral cancellous bone with a planar side surface of one polygonal delivery unit adjacent the planar side surface of another polygonal delivery unit.