Tissue fixation delivery apparatus

• US 9,277,914 B2
• Filed: 04/24/2015
• Issued: 03/08/2016
• 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 E
• Assistant Examiner(s): WEI, CHARLES M
• Application Number:
  US14/696,151
• Publication Number:
  US 20150230789A1
• Time in Patent Office: 319 Days
• Field of Search: 221/312.A, 446/472, 446/473, 446/483, 606/104, 606/143, 606/144, 606/147, 606/151, 606/232, 623/13.14
• US Class Current: 1/1
• 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 for applying suture clamps, clips or locks A61B2017/0488
• 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 tissue anchors, the device comprising:

a handle defining an internal cavity;

a tubular assembly extending distally from the handle and comprising a groove and a first side opening;

a needle cannula comprising an outer wall, a proximal portion disposed within the tubular assembly, an opposite sharpened distal tip having a distal opening, an internal chamber extending from the proximal portion through the distal opening, and a second side opening through the outer wall;

a plunger assembly slidably coupled to the handle and comprising a proximal end positioned external to and proximal to the handle and a push rod assembly, wherein portions of the plunger assembly are slidably disposed within the handle, the tubular assembly, and the needle cannula; and

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

wherein the device is configured and arranged so that, prior to deployment, a first tissue anchor can be disposed within the internal chamber of the needle cannula and a second tissue anchor can be disposed external to the internal chamber within the first side opening in the tubular assembly, and wherein the plunger assembly is positioned 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, further comprising the first tissue anchor disposed within the internal chamber of the needle cannula;

and

the second tissue anchor disposed external to the internal chamber within the first side opening in the tubular assembly.

3. The device of claim 2, further comprising an adjustable suture assembly coupled to the first anchor and the second anchor.

4. The device of claim 3, wherein the device is configured and arranged for the adjustable suture assembly to be releasably coupleable to the handle.

5. A method of using the device of claim 2, the method comprising:

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

advancing the plunger assembly to eject the first tissue anchor from the needle cannula into the patient tissue at the first location;

withdrawing the needle cannula from the first location;

inserting the sharpened distal tip into the patient tissue at a second location;

retracting the plunger assembly 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 the resilient band disposed about the needle cannula and the second tissue anchor;

advancing the plunger assembly to eject the second tissue anchor from the needle cannula into the patient tissue at the second location; and

withdrawing the needle cannula from the patient tissue.

6. The method of claim 5, wherein the device further comprises an adjustable suture assembly coupled to the first anchor and the second anchor, the method further comprising tightening the adjustable suture assembly.

7. The device of claim 1, wherein the plunger assembly comprises a plunger slidably coupled to the handle and comprising a proximal end of the handle and a distal end positioned within the internal cavity of the handle.

8. The device of claim 7, wherein the plunger assembly comprises

a first push rod extending distally from the plunger and slidably disposed within the tubular assembly, the first push rod comprising a distal mating feature;

and

a second push rod slidably disposed within the internal chamber of the needle cannula and comprising a proximal mating feature configured to engage the distal mating feature of the first push rod.

9. The device of claim 8, wherein the distal mating feature of the first push rod is releasably coupleable to the proximal mating feature of the second push rod.

10. The device of claim 1 wherein the tubular assembly comprises

a tubular shaft extending distally from the handle and comprising a distal end:

and

a tubular sleeve disposed about a portion of the needle cannula and comprising a proximal end, the groove, and the first side opening, the proximal end of the tubular sleeve configured to mate with the distal end of the tubular shaft.

11. The device of claim 10, wherein the distal end of the tubular shaft is configured and arranged to releasably mate with the proximal end of the tubular sleeve.

12. The device of claim 1, wherein the plunger assembly is configured and arranged to operate between an extended position and a retracted position wherein in the extended position the plunger assembly extends 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, wherein in the retracted position the plunger assembly is retracted to allow the second tissue anchor to be urged into the internal chamber through the first side opening and the second side opening by the resilient band.

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

14. A device for deploying a tissue fixation apparatus, the device comprising:

a handle defining an internal cavity;

a tubular shaft extending distally from the handle;

a plunger slidably coupled to the handle and comprising a proximal end positioned external to the handle and a distal end positioned within the internal cavity of the handle;

a handle push rod extending from the distal end of the plunger and slidably disposed within the tubular shaft;

a needle cannula comprising an outer wall, 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 disposed about a portion of the needle cannula and releasably mateable with the tubular shaft, the tubular sleeve comprising a groove and a sleeve side opening;

a cartridge push rod slidably disposed within the internal chamber of the needle cannula and releasably mateable with the handle push rod; and

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

wherein the device is configured and arranged to receive a first tissue anchor within the internal chamber of the needle cannula and a second tissue anchor within the side sleeve opening and external to the internal chamber of the needle cannula.

15. The device of claim 14, further comprising the first tissue anchor disposed within the internal chamber of the needle cannula;

and

the second tissue anchor disposed external to the internal chamber within the sleeve side opening in the tubular sleeve.

16. The device of claim 15, further comprising an adjustable suture assembly coupled to the first anchor and the second anchor.

17. The device of claim 16, wherein the device is configured and arranged for the adjustable suture assembly to be releasably coupleable to the handle.

18. A method of using the device of claim 15, the method comprising:

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

advancing the cartridge push rod within the needle cannula to eject the first tissue anchor from the needle cannula into the patient tissue at the first location;

withdrawing the needle cannula from the first location;

inserting the sharpened distal tip into the patient tissue at a second location;

retracting the cartridge 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 the resilient band disposed about the needle cannula and the second tissue anchor;

advancing the cartridge push rod within the needle cannula to eject the second tissue anchor from the needle cannula into the patient tissue at the second location; and

withdrawing the needle cannula from the patient tissue.

19. The method of claim 18, wherein the device further comprises an adjustable suture assembly coupled to the first anchor and the second anchor, the method further comprising tightening the adjustable suture assembly.

20. The device of claim 14, wherein the plunger and the handle push rod and the cartridge push rod are configured to operate between an extended position and a retracted position, wherein in the extended position the cartridge push rod is configured and arranged 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, wherein in the retracted position the cartridge push rod is positioned proximal to the sleeve side opening so as to allow the second tissue anchor to be urged into the internal chamber through the needle side opening by the resilient band.