Needle assembly and method for passing suture

• US 5,904,692 A
• Filed: 04/14/1997
• Issued: 05/18/1999
• Est. Priority Date: 04/14/1997
• Status: Expired due to Term

• Current Assignee: Mitek Surgical Products, Inc. (Johnson & Johnson)
• Original Assignee: Mitek Surgical Products, Inc. (Johnson & Johnson)
• Inventors: Jacob, Pamela, Morettin, Robert, Steckel, Mark
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/834,639
• Time in Patent Office: 764 Days
• Field of Search: 606/139, 606/148, 606/144, 606/147, 604/272, 128/898
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence

Abstract

A needle assembly for passing suture within the body includes a rigid needle having a proximal end and a pointed distal end, and an opening in the distal end extending through the needle for retaining a suture therein; a stop element positioned on the needle proximate to, and spaced from, the proximal end of the needle; a sheath having a lengthwise bore therethrough for slidably retaining the needle; and a lock member engageable with the needle stop element to prevent distal movement of the needle in the sheath bore. The needle distal end is movable to an exposed position for passing the assembly through tissue, and is movable to a shielded position within the sheath for passing the assembly safely past the tissue which is not to be penetrated. There is further contemplated a method for passing suture within the body, using the needle assembly.

Claims

1. A needle assembly for passing suture within the body, said assembly comprising:

a rigid needle having a proximal end and a pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

a sheath having a lengthwise bore therethrough for slidably retaining said needle; and

a lock member engageable with said stop element to prevent distal movement of said needle in said sheath bore, said lock member being hingedly attached to said sheath;

wherein said needle distal end is movable to an exposed position for passing said assembly through tissue, and is movable to a shielded position within said sheath for passing said assembly safely past tissue which is not to be penetrated.

2. An assembly according to claim 1 wherein said lock member is attached to said sheath by a living hinge.

3. An assembly according to claim 1 wherein said stop element comprises a block fixed on said needle, and said lock member is engageable with said block to prevent movement thereof, and thereby said needle, distally in said sheath.

4. An assembly according to claim 1 wherein said lock member is hingedly movable to a first position between said stop element and a proximal end of said sheath so as to prevent distal movement of said needle in said sheath, and is hingedly movable to a second position removed from said first position so as to permit said needle to move distally in said sheath.

5. An assembly according to claim 1 wherein said needle proximal end has fixed thereon a grip member.

6. An assembly according to claim 5 wherein said sheath has disposed thereon a grip portion.

7. An assembly according to claim 1 wherein at least a portion of said sheath is tapered such that said distal end thereof is smaller in diameter than said proximal end thereof.

8. An assembly according to claim 1 wherein said opening comprises an aperture.

9. An assembly according to claim 1 wherein an overall length of said needle distally of said stop element exceeds an overall length of said sheath by a distance at least equal to the length of said needle from said distal end thereof to a proximal extent of said opening, and wherein said overall length of said needle distally of said stop element is less than an overall length of said sheath and said lock member combined.

10. An assembly according to claim 1 wherein said needle opening is larger in width than a cross-section of the suture, and said bore proximate said distal end of said sheath is sufficiently spaced from said needle when said needle distal end is disposed in said bore, such that the suture is movable through said opening and said sheath distal end as said assembly is withdrawn from a site of attachment of the suture to said needle.

11. An assembly according to claim 10 wherein a portion of said bore proximal of said bore proximate said distal end of said sheath is sized to support said needle in said bore.

12. An assembly according to claim 1 wherein said opening extends widthwise through said needle.

13. An assembly according to claim 1 wherein said opening comprises a round hole.

14. An assembly according to claim 1 wherein said opening comprises an elongated hole, and a side opening extending through said needle so as to communicate with said elongated hole.

15. An assembly according to claim 1 wherein said opening is configured so that said distal end of said needle comprises a crochet hook.

16. A needle assembly for passing suture within the body, said assembly comprising:

a rigid needle having a proximal end and a pointed distal end, and an open in said distal end extending through said needle for retaining a suture therein;

a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

a sheath having a lengthwise bore therethrough for slidably retaining said needle; and

a lock member engageable with said stop element to prevent distal movement of said needle in said sheath bore;

wherein said needle opening is larger in width than a cross-section of the suture, and said sheath is provided with slots extending proximally from a distal end of said sheath, said slots having widths exceeding the width of the suture, such that the suture is movable through said opening and said sheath slots as said assembly is withdrawn from a site of attachment of the suture to said needle, and

wherein said needle distal end is movable to an exposed position for passing said assembly through tissue, and is movable to a shielded position within said sheath for passing said assembly safely past tissue which is not to be penetrated.

17. A needle assembly for passing suture within the body, said assembly comprising:

a rigid needle having a proximal end and a pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

a sheath having a lengthwise bore therethrough for slidably retaining said needle; and

a lock member engageable with said stop element to prevent distal movement of said needle in said sheath bore;

wherein said needle opening comprises an elongated slot larger in width than a cross-section of the suture, and said sheath is provided with opposed, radially-extending apertures, a first portion of said elongated slot being alignable with said apertures when said needle is extended beyond said sheath, and a second portion of said elongated slot being alignable with said apertures when said needle is retracted into said sheath, said apertures having a diameter larger than the diameter of the suture, such that the suture is movable through said opening and said sheath apertures as said assembly is withdrawn from a site of attachment of the suture to said needle, and

wherein said needle distal end is movable to an exposed position for passing said assembly through tissue, and is movable to a shielded position within said sheath for passing said assembly safely past tissue which is not to be penetrated.

18. A method for passing suture within the body, the method comprising the steps of:

(1) providing a needle assembly comprising;

(a) a rigid needle having a proximal end and a pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

(b) a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

(c) a sheath having a lengthwise bore therethrough for slidably retaining said needle; and

(d) a lock member engageable with said stop element to prevent distal movement of said needle in said sheath bore, said lock member being hingedly attached to said sheath;

(2) positioning said needle proximally in said sheath so as to cause said needle distal end to be located in said sheath distal end, and engaging said lock member with said stop member so as to prevent distal movement of said needle in said sheath;

(3) advancing said assembly within said body until said distal end of said sheath is adjacent to a piece of tissue through which a suture is to be passed;

(4) disengaging said lock member from said stop element and moving said needle distally until said stop element engages said sheath, so as to cause said needle distal end to extend from said distal end of said sheath;

(5) advancing said assembly through said piece of tissue until said needle exits the far side of said piece of tissue;

(6) passing a suture through said opening in said needle distal end;

(7) drawing said assembly and said suture back through said piece of tissue; and

(8) disengaging said suture from said needle.

19. A method for passing suture within the body, the method comprising the steps of:

(1) providing a needle assembly comprising;

(a) a rigid needle having a proximal end and a pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

(b) a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

(c) a sheath having a lengthwise bore therethrough for slidably retaining said needle; and

(d) a lock member hingedly attached to said sheath and engageable with said stop element to prevent distal movement of said needle in said sheath bore;

(2) disengaging said lock member from said stop element and moving said needle distally until said stop element engages said sheath, so as to cause said needle distal end to extend from a distal end of said sheath;

(3) advancing said assembly through a first piece of tissue at a first location;

(4) drawing said needle proximally in said sheath so as to cause said needle distal end to re-enter said sheath distal end, and engaging said lock member with said stop member to prevent distal movement of said needle in said sheath;

(5) advancing said assembly within said body until said distal end of said sheath is adjacent to a second piece of tissue, at a second location, through which a suture is to be passed;

(6) disengaging said lock member from said stop element and moving said needle distally until said stop element engages said sheath, so as to cause said needle distal end to extend from said distal end of said sheath;

(9) advancing said assembly through said second piece of tissue until said needle exits the far side of said second piece of tissue;

(10) passing a suture through said opening in said needle distal end;

(11) drawing said assembly and said suture back through said second piece of tissue; and

(12) disengaging said suture from said needle.

20. A method according to claim 19 wherein steps (4)-(11) are repeated in said second piece of tissue, at a third location, so as to provide two suture free ends extending from said second piece of tissue.

21. A method according to claim 19 wherein said opening comprises an aperture.

22. A method according to claim 19 wherein said stop element comprises a body fixed to said needle.

23. A method according to claim 19 wherein said sheath is tapered such that a distal end of said sheath is of a smaller diameter than a proximal end of said sheath.

24. A method according to claim 19 wherein said stop element is engageable with a proximal end of said sheath when said lock member is not engagement with said stop element.

25. A method according to claim 19 wherein said first piece of tissue comprises abdominal wall, and said second piece of tissue comprises vaginal tissue.

26. A method according to claim 19 including the additional step of fixing said suture to a bodily support member.

27. A method according to claim 19 wherein an overall length of said needle distally of said stop element exceeds an overall length of said sheath by a distance at least equal to the length of said needle from said distal end thereof to a proximal extent of said opening, and wherein said overall length of said needle distally of said stop element is less than an overall length of said sheath and said lock member combined.

28. A needle assembly for passing suture within the body, said assembly comprising:

a rigid needle having a proximal end and a pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

a sheath having a lengthwise bore therethrough for slidably retaining said needle;

a lock member pivotally attached to said needle and engageable with said sheath to prevent distal movement of said needle in said sheath bore;

wherein said needle distal end is movable to an exposed position for passing said assembly through tissue, and is movable to a shielded position within said sheath for passing said assembly safely past tissue which is not to be penetrated.

29. A needle assembly for passing suture within the body, said assembly comprising:

a needle having an axial length, a proximal end, pointed distal end, and an opening in said distal end extending through said needle for retaining a suture therein;

a stop element positioned on said needle proximate to, and spaced from, said proximal end of said needle;

a sheath including a distal end and a proximal end, having a shorter axial length than said axial length of said needle, and having a lengthwise bore therethrough for slidably receiving a portion of said needle such that said pointed distal end of said needle may be moved relative to said sheath between a first position wherein said pointed distal end resides within said distal end of said sheath and a second position wherein said pointed distal end of said needle projects outwardly from said distal end of said sheath; and

a lock member pivotally attached to said assembly for releasable engagement between said stop element and said proximal end of said sheath when said needle is in said first position;

whereby said needle distal end is movable relative to said sheath into said second position for the passing of said assembly through tissue, and is movable relative to said sheath into, and lockable in, said first position at other times.