Apparatus and method for repairing or reattaching soft tissue

• US 6,443,963 B1
• Filed: 07/26/2000
• Issued: 09/03/2002
• Est. Priority Date: 07/26/2000
• Status: Expired due to Fees

• Current Assignee: Orthopaedic Biosystems Ltd. Inc. (Smith & Nephew PLC)
• Original Assignee: Orthopaedic Biosystems Ltd. Inc. (Smith & Nephew PLC)
• Inventors: Vinluan, Jenine S., Hunter, Robert E., Baldwin, Jeffrey P, Hatch, Laird L.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/626,071
• Time in Patent Office: 769 Days
• Field of Search: 606/213, 606/219, 606/139, 606/14, 606/148
• US Class Current: 606/148
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks

Abstract

An apparatus and method for delivering or installing a surgical suture or suture-like implant into soft tissue, such as the meniscus of the knee, for example, for reattachment or repair of that tissue. The apparatus and method facilitate ease of placement of the suture or implant by the surgeon, protect surrounding tissue and nerves from damage during use, and permit suturing to occur through a single body portal. An injury to soft tissue, such as a tear in the meniscus of the knee joint or detachment of soft tissue from bone, is repaired through a single body portal by installing a surgical suture across the injury, tear, or detachment and passing that suture back through the body portal so that the suture can be joined and the injury, tear, or detachment can be reapproximated by the surgeon while working through the single body portal.

Claims

1. Apparatus for use in installing an implant in soft tissue, comprising

a guide structure insertable through a body portal and into proximity with the soft tissue, the guide structure being configured to guide a length of the implant through the soft tissue and to bring legs of the length of implant into proximity with each other, the guide structure being further configured to be withdrawn toward the body portal in a manner which (a) causes the guide structure to become disengaged from the length of implant, and (b) leaves the length of implant extending through the soft tissue and the legs of the length of implant in proximity with each other,

wherein the guide structure includes (a) a pair of guide portions supported in spaced apart relation to each other and defining a gap which enables soft tissue to be disposed between the guide portions, (b) a tissue piercing device moveable in the gap between the guide portions and configured to pierce soft tissue disposed in the gap between the guide portions, and (c) an introducer tube configured to receive and guide the length of implant, the introducer tube being moveable in opposite directions in the gap between the guide portions, the introducer tube being moveable in one direction to form a passageway in the gap for guiding the length of implant through soft tissue in the gap and in an opposite direction for reestablishing the gap between the guide portions, the guide portions being configured to guide the legs of the length of implant into proximity with each other, and the re-established gap between the guide portions enabling legs of the length of implant to pass therethrough as the guide structure is being withdrawn toward the body portal;

and

a force applying device including a drive wheel extending at least partially into the introducer tube, the drive wheel being rotatable about an axis and having an external surface configured for applying force to the length of implant disposed in the introducer tube to move the length of implant in the introducer tube.

2. Apparatus as defined in claim 1, wherein the force applying device is selectively engageable with the length of implant to drive the length of implant in the guide structure and selectively disengageable from the length of implant to enable the length of implant to slide in the guide structure.

3. Apparatus as defined in claim 2, wherein the guide structure is configured to be at least partially located within an articular space in order to install an implant in soft tissue located within the articular space.

4. Apparatus as defined in claim 2, wherein the guide structure is configured to be at least partially located within a knee to install an implant in the meniscus in the knee.

5. Apparatus as defined in claim 4, wherein the pair of guide portions comprises a pair of guide tubes, each of which is disposed in a common plane which has a thickness equal to the largest outer diameter of the pair of guide tubes, the gap being located in the common plane, the introducer tube being moveable in the common plane and configured to guide the length of implant in the common plane, the tissue piercing device being moveable in the common plane, and a thickness of the common plane being further dimensioned to enable the pair of guide tubes to be at least partially located within an articulated joint.

6. Apparatus as defined in claim 1, wherein the tissue piercing device is formed at a distal end of a shaft which is slideable in opposite directions in the introducer tube, the shaft enabling the tissue piercing device to be moveable in one direction in the gap between the guide portions to pierce soft tissue and in an opposite direction for withdrawing the tissue piercing device from the introducer tube, so that a length of implant can be inserted in and is moveable in the introducer tube.

7. Apparatus as defined in claim 6, wherein a handle is fixed to a proximal end of the shaft.

8. Apparatus as defined in claim 6, wherein the introducer includes a distal end portion located to follow the tissue piercing device through soft tissue and to extend at least partially into one of the pair of guide tubes to form the passageway.

9. Apparatus as defined in claim 8, wherein the guide tubes are fixed to each other, and the introducer tube is moveable in at least one of the guide tubes.

10. Apparatus as defined in claim 1, wherein at least one of the pair of guide portions has a bend configured to enable the at least one of the pair of guide portions to extend about anatomical structures.

11. Apparatus as defined in claim 10, wherein the pair of guide portions comprises a pair of guide tubes, and the introducer tube is moveable within the at least one of the pair of guide tubes, the introducer tube having a flexibility that enables the introducer tube to move lengthwise in the at least one of the pair of guide tubes despite the bend.

12. Apparatus as defined in claim 1, wherein the drive wheel is selectively moveable in one direction transverse to the length of implant to engage and drive the length of implant, and in an opposite direction to disengage from the length of implant to allow the length of implant to slide within the introducer tube.

13. Apparatus as defined in claim 12, wherein the force applying device further comprises a second wheel rotatable about an axis parallel to the axis of the drive wheel, the second wheel having an outer surface engaging the drive wheel in a manner which rotates the drive wheel in the opposite direction as the second wheel, thereby enabling forces to be applied to the second wheel in the same direction in which the length of implant is intended to be moved.

14. Apparatus as defined in claim 1, wherein the force applying device further comprises a second wheel rotatable about an axis parallel to the axis of said drive wheel, the second wheel having an outer surface engaging the drive wheel in a manner which rotates the drive wheel in the opposite direction as the second wheel, thereby enabling forces to be applied to the second wheel in the same directions in which the length of implant is intended to be moved.

15. Apparatus as defined in claim 1, wherein the pair of guide portions comprises a pair of guide tube sets, each of which comprises a pair of adjacent guide tubes, the pair of guide tube sets configured to enable portions of the length of implant to be guided through soft tissue, and at least one pair of adjacent guide tubes being further configured to maintain legs of the portions of implant in adjacent spaced relation to each other as the portions of implant are guided through soft tissue.

16. Apparatus as defined in claim 15, wherein at least one pair of adjacent guide tubes comprises a single lumen tube structure defining a pair of tube portions and a reduced central portion joining the pair of tube portions, each of the pair of tube portions configured to guide a portion of the length of implant in a lengthwise direction, and the central portion configured to maintain said pair of tube portions in spaced relation to each other and allowing a connecting portion of the length of implant to slide sideways in the central portion with an interference fit.

17. Apparatus as defined in claim 1, wherein at least one of a pair of guide portions comprises a single lumen tube structure defining a pair of tube portions and a reduced central portion joining the pair of tube portions, each of the pair of tube portions configured to guide a portion of the length of implant in a lengthwise direction, and the central portion configured to maintain the pair of tube portions in spaced relation to each other and allowing a connecting portion of the length of implant to slide sideways in the central portion with an interference fit.

18. Apparatus as defined in claim 1, wherein the guide structure comprises a guide tube and a receiver connected with the guide tube.

19. Apparatus as defined in claim 18, wherein the receiver comprises a plurality of elements configured to form an opening for receiving and retaining the length of implant guided through torn tissue.

20. Apparatus as defined in claim 19, wherein the plurality of elements are moveable relative to each other to form the opening, the guide structure further comprising a manipulator for selectively moving the plurality of elements relative to each other to form the opening.

21. Apparatus as defined in claim 19, wherein the plurality of elements are flexible and are biased toward an orientation in which the elements form the opening, the flexibility of the elements enabling the elements to be spread apart as the length of implant is guided through the opening, and the bias of the elements enabling the elements to return to the orientation after the length of implant is in the opening, thereby retaining the length of implant in the opening.

22. Apparatus as defined in claim 19, wherein the plurality of elements are flexible and are biased toward an orientation in which the elements form the opening, the flexibility of the elements enabling the elements to spread apart as a tissue-piercing device connected to the length of implant is guided through the opening, and the bias of the elements enabling the elements to return to the orientation after the tissue-piercing device is in the opening, thereby retaining the tissue-piercing device in the opening.

23. Apparatus as defined in claim 22, wherein the tissue-piercing device is fixed to the length of implant, and wherein a shield is connected to the guide structure, the shield configured to prevent the tissue piercing structure from piercing other body tissue after the tissue-piercing device has pierced soft tissue and guided the implant into the receiver.

24. Apparatus as defined in claim 20, wherein a tissue-piercing device is fixed to the length of implant, and wherein a shield is connected to the guide structure, the shield configured to prevent the tissue-piercing device from piercing other body tissue after the tissue-piercing device has pierced soft tissue and guided the implant into the receiver.

25. Apparatus as defined in claim 1, wherein the guide structure comprises adjacent guide and receiver tubes and a channel device connected to a support member, the adjacent guide and receiver tubes being spaced from the channel device so that soft tissue in which an implant is being inserted can be disposed between the adjacent guide and receiver tubes and the channel, the channel device being configured to (i) receive the length of implant extending through the guide tube and through soft tissue and (ii) guide the length of implant back through the soft tissue and toward the receiver tube.

26. A method for installing an implant in soft tissue, comprising

providing a guide structure as set forth in claim 1,

locating the guide structure in a selected orientation with respect to the soft tissue,

operating the guide structure to guide a length of implant through the soft tissue, and

withdrawing the guide structure from the soft tissue in a manner which maintains the implant in the soft tissue and disengages the guide structure from the length of implant with legs of the length of implant in proximity to each other.

27. The method as defined in claim 26, further comprising

manipulating the guide structure into a selected orientation after the length of implant has been guided through the soft tissue, the selected orientation enabling friction between the length of implant and the soft tissue to cause the guide structure to disengage from the length of implant as the guide structure is withdrawn from the soft tissue.

28. A method for installing an implant in soft tissue within an articular space, comprising

providing a guide structure as defined in claim 1,

locating the guide structure in a first selected orientation relative to soft tissue in the articular space,

operating the guide structure to guide a length of implant through the soft tissue in the articular space, and

manipulating the guide structure into a second selected orientation after the length of implant has been guided through the soft tissue, the second selected orientation enabling friction between the length of implant and the soft tissue to cause the guide structure to disengage from the length of implant as the guide structure is withdrawn from the soft tissue.

29. A method as defined in claim 28, wherein the articular space comprises a knee joint repair space and the soft tissue comprises a meniscus.

30. Apparatus for use in installing an implant in soft tissue, comprising

a guide structure insertable through a body portal and into proximity with the soft tissue, the guide structure being configured to guide a length of the implant through the soft tissue and to bring legs of the length of implant into proximity with each other, the guide structure being further configured to be withdrawn toward the body portal in a manner which (a) causes the guide structure to become disengaged from the length of implant, and (b) leaves the length of implant extending through the soft tissue and the legs of the length of implant in proximity with each other,

wherein the guide structure includes (a) a pair of guide portions supported in spaced apart relation to each other and defining a gap which enables soft tissue to be disposed between the guide portions, (b) a tissue piercing device moveable in the gap between the guide portions and configured to pierce soft tissue disposed in the gap between the guide portions, and (c) an introducer moveable in opposite directions in the gap between the guide portions, the introducer being moveable in one direction to form a passageway in the gap for guiding the length of implant through soft tissue in the gap and in an opposite direction for reestablishing the gap between the guide portions;

the guide portions being configured to guide the legs of the length of implant into proximity with each other, the pair of guide portions including a pair of guide tube sets, each of which includes a pair of adjacent guide tubes, the pair of guide tube sets configured to enable portions of the length of implant to be guided through soft tissue, and at least one pair of adjacent guide tubes being further configured to maintain legs of the portions of implant in adjacent spaced relation to each other as the portions of implant are guided through soft tissue; and

the re-established gap between the guide portions enabling legs of the length of implant to pass therethrough as the guide structure is being withdrawn toward the body portal.

31. Apparatus as defined in claim 30, wherein at least one pair of adjacent guide tubes comprises a single lumen tube structure defining a pair of tube portions and a reduced central portion joining the pair of tube portions, each of the pair of tube portions configured to guide a portion of the length of implant in a lengthwise direction, and the central portion configured to maintain said pair of tube portions in spaced relation to each other and allowing a connecting portion of the length of implant to slide sideways in the central portion with an interference fit.

32. Apparatus for use in installing an implant in soft tissue, comprising

a guide structure insertable through a body portal and into proximity with the soft tissue, the guide structure being configured to guide a length of the implant through the soft tissue and to bring legs of the length of implant into proximity with each other, the guide structure being further configured to be withdrawn toward the body portal in a manner which (a) causes the guide structure to become disengaged from the length of implant, and (b) leaves the length of implant extending through the soft tissue and the legs of the length of implant in proximity with each other,

wherein the guide structure includes (a) a pair of guide portions supported in spaced apart relation to each other and defining a gap which enables soft tissue to be disposed between the guide portions, (b) a tissue piercing device moveable in the gap between the guide portions and configured to pierce soft tissue disposed in the gap between the guide portions, and (c) an introducer moveable in opposite directions in the gap between the guide portions, the introducer tube moveable in one direction to form a passageway in the gap for guiding the length of implant through soft tissue in the gap and in an opposite direction for reestablishing the gap between the guide portions;

the guide portions being configured to guide the legs of the length of implant into proximity with each other, at least one of a pair of guide portions including a single lumen tube structure defining a pair of tube portions and a reduced central portion joining the pair of tube portions, each of the pair of tube portions configured to guide a portion of the length of implant in a lengthwise direction, and the central portion configured to maintain the pair of tube portions in spaced relation to each other and allowing a connecting portion of the length of implant to slide sideways in the central portion with an interference fit; and

the re-established gap between the guide portions enabling legs of the length of implant to pass therethrough as the guide structure is being withdrawn toward the body portal.

33. Apparatus for use in installing an implant in soft tissue, comprising

a guide structure insertable through a body portal and into proximity with the soft tissue, the guide structure being configured to guide a length of the implant through the soft tissue and to bring legs of the length of implant into proximity with each other, the guide structure being further configured to be withdrawn toward the body portal in a manner which (a) causes the guide structure to become disengaged from the length of implant, and (b) leaves the length of implant extending through the soft tissue and the legs of the length of implant in proximity with each other,

wherein the guide structure includes a guide tube and a receiver connected with the guide tube, the receiver including a plurality of elements configured to form an opening for receiving and retaining the length of implant guided through torn tissue.

34. Apparatus as defined in claim 33, wherein the plurality of elements are moveable relative to each other to form the opening, the guide structure further includes a manipulator for selectively moving the plurality of elements relative to each other to form the opening.

35. Apparatus as defined in claim 33, wherein the plurality of elements are flexible and are biased toward an orientation in which the elements form the opening, the flexibility of the elements enabling the elements to be spread apart as the length of implant is guided through the opening, and the bias of the elements enabling the elements to return to the orientation after the length of implant is in the opening, thereby retaining the length of implant in the opening.

36. Apparatus as defined in claim 33, wherein the plurality of elements are flexible and are biased toward an orientation in which the elements form the opening, the flexibility of the elements enabling the elements to spread apart as a tissue-piercing device connected to the length of implant is guided through the opening, and the bias of the elements enabling the elements to return to the orientation after the tissue-piercing device is in the opening, thereby retaining the tissue-piercing device in the opening.

37. Apparatus as defined in claim 36, wherein the tissue-piercing device is fixed to the length of implant, and wherein a shield is connected to the guide structure, the shield configured to prevent the tissue piercing structure from piercing other body tissue after the tissue-piercing device has pierced soft tissue and guided the implant into the receiver.

38. Apparatus as defined in claim 34, wherein a tissue-piercing device is fixed to the length of implant, and wherein a shield is connected to the guide structure, the shield configured to prevent the tissue-piercing device from piercing other body tissue after the tissue-piercing device has pierced soft tissue and guided the implant into the receiver.