Tissue fixation delivery apparatus

• US 9,039,740 B2
• Filed: 09/11/2013
• Issued: 05/26/2015
• Est. Priority Date: 09/21/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Wales, Lawrence W., Bentley, Ishmael
• Primary Examiner(s): Manahan, Todd
• Assistant Examiner(s): WEI, CHARLES M
• Application Number:
  US14/024,259
• Publication Number:
  US 20140088646A1
• Time in Patent Office: 622 Days
• Field of Search: 606/232, 606/143, 606/144, 606/104, 606/147, 606/151, 623/13.14, 221/312.A, 446/472, 446/473, 446/483
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue

Abstract

A device for deploying a tissue fixation apparatus of the type including first and second tissue anchors coupled together by an adjustable suture assembly. The device comprises a handle mechanism and a needle cartridge assembly releasably coupled to the handle mechanism. The needle cartridge assembly includes a needle cannula with a side opening through which a tissue anchor can be loaded into an internal chamber of the needle cannula. A push rod is disposed in the needle cannula and is operable between an extended position in which the push rod prevents the tissue anchor from entering the chamber through the side opening, and a retracted configuration in which the tissue anchor can be pushed into the chamber under the action of a resilient band positioned over the side opening.

Claims

1. A device for deploying a tissue fixation apparatus of the type including first and second tissue anchors coupled together by an adjustable suture assembly, the device comprising:

a handle mechanism including;

a handle body having a proximal end and a distal end and an internal cavity disposed therebetween;

a tubular shaft extending distally from the handle body and having a distal end;

a plunger slidably and rotatably coupled to the body having a proximal end and a distal end, the proximal end positioned external to and proximal to the handle body, the distal end positioned within the internal cavity of the body;

a handle push rod extending distally from the plunger and slidably and rotatably disposed within the tubular shaft, the handle push rod including a distal mating feature; and

a needle cartridge assembly releasably coupled to the handle mechanism including;

a needle cannula having an outer wall defining a proximal portion, an opposite sharpened distal tip having a distal opening, an internal chamber extending from the proximal portion through the distal opening, and a needle side opening through the outer wall;

a tubular sleeve fixedly disposed about a portion of the needle cannula having a proximal end and a distal end, the proximal end of the tubular sleeve configured to mate with the distal end of the tubular shaft of the handle mechanism for coupling the handle mechanism and the needle cartridge assembly, and further including a groove and a sleeve side opening radially and axially aligned with the needle side opening;

a cartridge push rod slidably and rotatably disposed within the chamber of the needle cannula including a proximal mating feature configured to engage the distal mating feature of the handle push rod; and

a resilient band disposed about the tubular sleeve within the groove and over the side opening;

wherein prior to deployment the first tissue anchor is disposed within the internal chamber of the needle cannula and the second tissue anchor is disposed external to the internal chamber within the side opening in the sleeve, and wherein the plunger, the handle push rod and the cartridge push rod are positioned such that the cartridge push rod operates to prevent the second tissue anchor from entering the internal chamber while the resilient band operates to urge the second tissue anchor toward the internal chamber.

2. The device of claim 1, wherein the plunger and the handle and cartridge push rods are configured to operate between at least one extended position and at least one retracted position, wherein in the at least one extended position the cartridge push rod is located so as to eject the first tissue anchor from the chamber through the distal opening of the needle cannula while preventing the second tissue anchor from entering the internal chamber, and wherein in the at least one retracted position the cartridge push rod is positioned proximal to the side opening in the sleeve so as to allow the second tissue anchor to be urged into the internal chamber through the needle side opening by the resilient band.

3. The device of claim 2, wherein the plunger and the handle and cartridge push rods are further configured to be operable to eject the second tissue anchor from the internal chamber through the distal opening of the needle cannula.

4. The device of claim 1, wherein the proximal end of the tubular sleeve includes a proximal opening configured to receive the distal end of the tubular shaft of the handle mechanism so as to couple the handle mechanism to the needle cartridge assembly.

5. The device of claim 4, wherein the distal end of the tubular shaft and the proximal opening of the tubular sleeve are sized to form an interference fit therebetween to couple the handle mechanism to the needle cartridge assembly.

6. The device of claim 5, wherein the distal end of the tubular shaft includes an alignment pin extending radially outward therefrom, and wherein the proximal end of the tubular sleeve includes a notch sized to receive the alignment pin to radially align the handle mechanism and the needle cartridge.

7. The device of claim 1, wherein the handle mechanism and the needle cartridge assembly are releasably couple to one another in such a way that, upon relative separation thereof, the distal mating feature of the handle push rod and the proximal mating feature of the cartridge push rod are configured to disengage one another.

8. The device of claim 1, wherein the plunger has an intermediate section including an outer surface and a groove arrangement therein, and wherein the handle mechanism further includes a guide pin extending radially inward, the guide pin being spring biased toward the plunger so as to extend partially within the groove arrangement to regulate longitudinal and rotational movement of the plunger relative to the handle body.

9. The device of claim 1, wherein prior to complete deployment of the tissue fixation apparatus a portion of the suture assembly is releasably coupled to the handle mechanism.

10. The device of claim 1, wherein the tubular sleeve and the needle cannula each further include a slot extending from the distal end thereof to the side opening thereof, the tubular sleeve slot being radially aligned with the slot in the needle cannula.

11. The device of claim 10, wherein the slots of the tubular sleeve and the needle cannula are sized to receive at least a portion of the adjustable suture assembly of the tissue fixation apparatus.

12. A method of deploying a tissue fixation apparatus of the type including first and second tissue anchors coupled together by an adjustable suture assembly, the tissue fixation apparatus being pre-loaded onto a delivery tool with the first tissue anchor disposed within an interior chamber of a needle cannula of the delivery tool, the method comprising:

inserting a sharpened distal tip of the needle cannula into target tissue at a first location;

advancing a push rod distally within the needle cannula to eject the first tissue anchor from the needle cannula within the target tissue at the first location;

withdrawing the needle cannula from the first location and inserting the sharpened distal tip into the target tissue at a second location;

withdrawing the push rod with respect to the needle cannula to allow the second tissue anchor to be pushed into the interior chamber of the needle cannula under the operation of a resilient band disposed about the needle cannula and the second tissue anchor;

advancing the push rod distally within the needle cannula to eject the second tissue anchor from the needle cannula within the target tissue at the second location; and

withdrawing the needle cannula from the tissue and tightening the tissue fixation apparatus.

13. The method of claim 12, wherein the delivery tool includes a handle mechanism and a needle cartridge assembly including the needle cannula, and wherein the tissue fixation apparatus is preloaded onto the needle cartridge assembly, and wherein the method further comprises coupling the handle mechanism and the needle cartridge assembly together prior to inserting the sharpened distal tip of the needle cannula into the target tissue.

14. The method of claim 13, further comprising decoupling the needle cartridge assembly and the handle mechanism after withdrawing the needle cannula from the target tissue.

15. The method of claim 13, wherein coupling the handle mechanism and the needle cartridge assembly together includes inserting a tubular shaft of the handle mechanism into a proximal opening of the needle cartridge assembly.

16. A tissue fixation system comprising:

a handle mechanism including;

a handle body having a proximal end and a distal end and an internal cavity disposed therebetween;

a tubular shaft extending distally from the handle body and having a distal end;

a plunger slidably and rotatably coupled to the body having a proximal end and a distal end, the proximal end positioned external to and proximal to the handle body, the distal end positioned within the internal cavity of the body; and

a handle push rod extending distally from the plunger and slidably and rotatably disposed within the tubular shaft, the handle push rod including a distal mating feature; and

a kit including a needle cartridge assembly and a tissue fixation apparatus coupled thereto;

the needle cartridge assembly including;

a needle cannula having an outer wall defining a proximal portion, an opposite sharpened distal tip having a distal opening, an internal chamber extending from the proximal portion through the distal opening, and a needle side opening through the outer wall;

a tubular sleeve fixedly disposed about a portion of the needle cannula having a proximal end and a distal end, the proximal end of the tubular sleeve configured to mate with the distal end of the tubular shaft of the handle mechanism for coupling the handle mechanism and the needle cartridge assembly, and further including a groove and a sleeve side opening radially and axially aligned with the needle side opening;

a cartridge push rod slidably and rotatably disposed within the internal chamber of the needle cannula including a proximal mating feature configured to engage the distal mating feature of the handle push rod; and

a resilient band disposed about the tubular sleeve within the groove and over the side opening; and

the tissue fixation apparatus including a first tissue anchor, a second tissue anchor, and an adjustable suture assembly coupling the first and second tissue anchors together, the adjustable suture assembly including an adjustable suture loop and a tension line, wherein the first and second tissue anchors are coupled to the adjustable suture loop, and wherein the tension line is operable to reduce a dimension of the adjustable suture loop between the first and second tissue anchors, wherein the first tissue anchor is disposed within the internal chamber of the needle cannula, and wherein the second tissue is disposed external to the internal chamber and within the needle and sleeve side openings, and wherein the resilient band is disposed about the tubular sleeve over the second tissue anchor so as to urge the second tissue anchor toward the internal chamber through the needle and sleeve side openings, and wherein the cartridge push rod is positioned so as to prevent the second tissue anchor from entering the internal chamber,

wherein upon coupling the tubular shaft of the handle mechanism and the tubular sleeve of the needle cartridge assembly together, and further wherein upon coupling the mating features of the handle and needle push rods together, the plunger and the handle and cartridge push rods are configured to operate between at least one extended position and at least one retracted position, wherein in the at least one extended position the cartridge push rod is located so as to eject the first tissue anchor from the internal chamber through the distal opening of the needle cannula while preventing the second tissue anchor from entering the internal chamber, and wherein in the at least one retracted position the cartridge push rod is positioned proximal to the side opening in the sleeve so as to allow the second tissue anchor to be urged into the internal chamber through the needle side opening by the resilient band.

17. The tissue fixation system of claim 16, wherein the proximal end of the tubular sleeve includes a proximal opening configured to receive the distal end of the tubular shaft of the handle mechanism so as to couple the handle mechanism to the needle cartridge assembly.

18. The tissue fixation system of claim 17, wherein the distal end of the tubular shaft and the proximal opening of the tubular sleeve are sized to form an interference fit therebetween to couple the handle mechanism to the needle cartridge assembly.

19. The tissue fixation system of claim 18, wherein the distal end of the tubular shaft includes an alignment pin extending radially outward therefrom, and wherein the proximal end of the tubular sleeve includes a notch sized to receive the alignment pin to radially align the handle mechanism and the needle cartridge assembly.

20. The tissue fixation system of claim 16, wherein the tubular sleeve and the needle cannula each further includes a slot extending from the distal end thereof to the side opening thereof, the tubular sleeve slot being radially aligned with the slot in the needle cannula, and wherein the slots of the tubular sleeve and the needle cannula are sized to receive at least a portion of the adjustable suture assembly of the tissue fixation apparatus.