Apparatus and methods for independently conditioning and pretensioning a plurality of ligament grafts during joint repair surgery

• US 6,679,889 B1
• Filed: 11/13/2000
• Issued: 01/20/2004
• Est. Priority Date: 11/13/2000
• Status: Expired due to Term

• Current Assignee: HS West Investments, LLC
• Original Assignee: HS West Investments, LLC
• Inventors: West, John R., West, Hugh S. Jr.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Farah, Ahmed M
• Application Number:
  US09/711,488
• Time in Patent Office: 1,163 Days
• Field of Search: 606/53, 606/54, 606/57, 606/60, 606/63, 606/68, 606/72, 606/73, 606/86, 606/88, 606/96, 606/102, 623/13-1-, 128/898
• US Class Current: 606/88
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: Y10S 606/916 Tool for installing or removing orthopedic fastener

Abstract

Apparatus and methods for conditioning and pre-tensioning soft tissue grafts during joint repair surgery, such as during repair of the anterior cruciate ligament (ACL). The inventive apparatus is advantageously adapted and configured so as to enable a surgeon to independently apply a desired tensile load onto individual strands of a multiple-stranded soft tissue graft, such each of a pair of ham strings. The inventive methods advantageously ensure that each strand of a multiple-strand soft tissue graft is adequately tensioned so as to both “condition” the graft to prevent subsequent stretching, relaxation or elongation following surgery, which can destabilize the joint, and pre-tension each strand of the graft to a desired amount so that each significantly contributes to the strength and stability of the joint, thus resulting in a stronger and more durable joint. The inventive tensioning device is advantageously equipped with structure for fastening or otherwise attaching the device to a patient'"'"'s limb during the conditioning and pre-tensioning procedure. It has multiple adjustable tension applicators that can be independently manipulated so as to independently apply a desired tensile load onto one or more strands of the soft tissue graft attached to each adjustable tension applicator.

Claims

1. A tensioning device for use in joint repair surgery comprising:

means for removably attaching the tensioning device to a person'"'"'s limb;

first tensioning means for selectively increasing or decreasing a first tensile load applied to a first strand of a soft tissue graft;

second tensioning means for selectively increasing or decreasing a second tensile load applied to a second strand of a soft tissue graft independently from the first tensile load applied to the first soft tissue graft strand; and

a suture attachment wheel rotatably connected to at least one of the first or second tensioning means so that when a suture strand is looped around the suture attachment wheel equal tension is applied to each side of the looped suture strand.

2. A tensioning device as defined in claim 1, wherein the means for removably attaching the tensioning device to a person'"'"'s limb includes at least one hollow pin guide that is sized and configured so as to slidably attach to a corresponding guide pin affixed to the person'"'"'s limb so that the tensioning device can be selectively attached and detached from the person'"'"'s limb while the guide pin remains affixed to the person'"'"'s limb.

3. A tensioning device as defined in claim 1, wherein each of the first and second tensioning means includes an adjustable tensioning apparatus having:

a tensioning piston adapted to receive and secure thereto one or more sutures attached to at least one soft tissue graft strand;

a hollow cylinder slidably disposed around at least a portion of the tensioning piston;

a spring disposed within the hollow cylinder and communicating between the hollow cylinder and tensioning piston so as to increase the tensile load applied by the tensioning piston onto the soft tissue graft strand as the spring is compressed; and

a tensioning bolt in threaded communication with the hollow cylinder in a manner so that selective rotation of the tensioning bolt causes a corresponding movement of the hollow cylinder relative to the tensioning bolt.

4. A tensioning device as defined in claim 3, wherein each tensioning piston includes a suture attachment wheel rotatably attached thereto.

5. A tensioning device as defined in claim 3, wherein the tensioning piston includes at least one of a slot, posts, hole or ridge configured so as to assist in securing at least one suture to the tensioning piston.

6. A tensioning device as defined in claim 3, further including gauge means for measuring the tensile load applied by at least one of the first and second tensioning means.

7. A tensioning device as defined in claim 6, wherein the gauge means includes a plurality of graduations disposed on an outer surface of the hollow cylinder.

8. A tensioning device as defined in claim 1, further including a temporary guide post sized and configured at one end to be received within a corresponding hole in the person'"'"'s limb and sized and configured at an opposite end to be removably attached to a guide post hole within the attachment means.

9. A tensioning device for use in joint repair surgery comprising:

an attachment portion comprising a plurality of hollow pin guides, each hollow pin guide being configured to slidably receive a corresponding guide pin affixed to a person'"'"'s limb so that the tensioning device can be selectively attached and detached from the person'"'"'s limb while the guide pin remains affixed to the person'"'"'s limb; and

a tensioning portion associated with the attachment portion and configured to independently apply a desired tensile load to each of at least two separate strands of a soft tissue graft, the tensioning portion comprising;

a first adjustable tensioning apparatus configured so as to selectively increase or decrease a first tensile load applied to a first strand of a soft tissue graft; and

a second adjustable tensioning apparatus configured so as selectively increase or decrease a second tensile load applied to a second strand of the soft tissue graft independently from the tensile load applied to the first strand of the soft tissue graft.

10. A tensioning device as defined in claim 9, wherein the attachment portion and the tensioning portion are removably attached to each other such that they may be selectively attached and detached.

11. A tensioning device as defined in claim 9, wherein the attachment portion and the tensioning portion are permanently affixed to each other.

12. A method for conditioning and pre-tensioning a multiple-stranded soft tissue graft during joint repair surgery, comprising:

providing a multiple-stranded soft tissue graft including at least two soft tissue strands for use in repairing a patient'"'"'s joint;

attaching a first end of each soft tissue strand to a first bone associated with the patient'"'"'s joint while leaving a free end of each soft tissue strand to enable subsequent conditioning and pre-tensioning of each soft tissue strand;

applying a first tensile load to the free end of a first soft tissue strand;

applying a second tensile load to the free end of a second soft tissue strand independently from the first tensile load applied to the first soft tissue strand;

conditioning the soft tissue strands by repeatedly flexing and extending the patient'"'"'s joint; and

independently adjusting the tensile loads applied to the free ends of each of the first and second soft tissue strands so as to apply a desired final tensile load to each of the first and second soft tissue strands in preparation for securing the first and second soft tissue strands to a second bone associated with the patient'"'"'s joint.

13. A method as defined in claim 12, further including the step of attaching at least one suture strand to the free end of each soft tissue strand, wherein a tensile load is applied to each soft tissue strand by means of applying the tensile load to the at least one suture attached to the soft tissue strand.

14. A method as defined in claim 12, wherein the multiple-stranded soft tissue graft comprises at least two ham string strands and wherein the method is part of a procedure for reconstructing the patient'"'"'s anterior cruciate ligament.

15. A method as defined in claim 12, wherein the multiple-stranded soft tissue graft comprises at least two patellar tendon strands and wherein the method is part of a procedure for reconstructing the patient'"'"'s anterior cruciate ligament.

16. A method as defined in claim 12, wherein the method further includes repeating the acts of conditioning the soft tissue strands and independently adjusting the tensile loads applied to the free ends of each of the first and second soft tissue strands until the patient'"'"'s joint has a desired level of stability.

17. A method as defined in claim 12, further including the step of securing the free ends of the soft tissue strands to the second bone associated with the patient'"'"'s joint.

18. A method as defined in claim 17, wherein the multiple-stranded soft tissue graft is secured to the second bone by means of an anchor device that includes an outer sheath configured to fit within a hole in the second bone, a lip associated with the outer sheath and configured to overlap the second bone in order to limit penetration of the outer sheath through the hole in the second bone, and an inner core slidably disposed within the outer sheath.

19. A method as defined in claim 17, wherein the free ends of the soft tissue strands are secured within a hole in the second bone by inserting an interference screw into the hole.

20. A tensioning device for use in joint repair surgery comprising:

a tensioning block comprising a plurality of independently adjustable tension applicators, each tension applicator comprising;

a hollow cylinder slidably connected to the tensioning block so as to be selectively advanced or withdrawn relative to a joint being repaired when the tensioning device is in use,

a tensioning piston slidably received within the hollow cylinder and adapted to receive and secure one or more suture strands attached to a first soft tissue graft strand;

a tensioning bolt in threaded communication with the hollow cylinder in a manner so that selective rotation of the tensioning bolt causes corresponding movement of the hollow cylinder relative to the tensioning block; and

a biasing spring disposed within the hollow cylinder in a manner so as to communicate between the hollow cylinder and the tensioning piston, wherein compressing the biasing spring increases a tensile load applied by the tensioning piston to one or more suture strands attached thereto and decompressing the biasing spring decreases the tensile load.

21. A tensioning device as defined in claim 20, further comprising a suture attachment wheel rotatably connected to the tensioning piston so that, when a suture strand is looped around the suture attachment wheel, equal tension is applied by the tensioning piston to each side of the looped suture strand.