Instruments for delivering transfascial sutures, transfascial assemblies, and methods of transfascial suturing

• US 9,393,007 B2
• Filed: 06/09/2011
• Issued: 07/19/2016
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Darois, Roger E., Ziniti, Donald E., Ranucci, Kevin J.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/157,172
• Publication Number:
  US 20110306990A1
• Time in Patent Office: 1,867 Days
• Field of Search: 606/139, 606/142, 606/232, 606144-148
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/0469 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 : Delivery tools therefor

Abstract

An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and a pair of needles that are moveable to an extended position beyond the end of the shaft. One or more sutures are carried by the instrument and may be delivered transfascially. A transfascial suture assembly includes a suture having a first segment, a second segment, and an intermediate segment therebetween. A force distributing member is locatable at the intermediate segment. Suture retainers may be provided at the end of each suture segment, and may have a connection that is moveable relative to the portion of the suture segment connected therewith. A method of delivering transfascial sutures includes inserting a twin-needle instrument loaded with one or more sutures into an abdominal cavity and deploying, from within the abdominal cavity, the suture carrying needles through a soft tissue repair patch and then through at least part of the abdominal wall.

Claims

1. An instrument for delivering a transfascial suture, comprising:

an actuation handle to actuate the instrument;

an elongated shaft extending from the handle and including a distal end;

a first needle and a second needle that are operatively coupled to the actuation handle, the first and second needles being moveable to an extended position beyond the distal end of the shaft in response to actuation of the instrument and to a retracted position within the shaft, each needle being solid and having a sharp end adapted to pierce a soft tissue repair prosthetic and abdominal wall tissue; and

a suture carried by the instrument, the suture defined by a first segment, a second segment and an intermediate segment between the first and second segments and including an implantable force distributing member at the intermediate segment between the first and second segments, the force distributing member constructed and arranged to be positioned between and against the intermediate segment and the soft tissue repair prosthetic when the soft tissue repair prosthetic is secured to the abdominal wall tissue with the suture to distribute force applied along the intermediate segment, the first and second suture segments individually extending from the force distributing member at first and second locations thereof separated from each other by a portion of the force distributing member, the intermediate segment to extend directly from the first location to the second location against the portion of the force distributing member when the soft tissue repair prosthetic is secured to the abdominal wall tissue with the suture, the suture arranged in the instrument so that the first and second suture segments are coupled to an external portion of the first and second needles and carried by the needles as the needles move to the extended position, the suture segments being releasable from the needles.

2. The instrument of claim 1, wherein the suture segments pay out as the needles move to the extended position.

3. The instrument of claim 1, wherein the pair of needles are arranged to move along a parallel needle path.

4. The instrument of claim 1, wherein the pair of needles are arranged to move along a diverging path.

5. The instrument recited in claim 1, further comprising a first suture retainer connected to the first segment and supported on the external portion of the first needle, and a second suture retainer connected to the second segment and supported on the external portion of the second needle.

6. The instrument recited in claim 5, wherein the first and second suture retainers include an axial through-bore adapted to receive the respective first and second needles.

7. The instrument recited in claim 5, wherein the first and second suture retainers are configured to be carried by the first and second needles as they move to the extended position.

8. The instrument recited in claim 5, wherein each of the first and second needles includes a narrow tip and a proximal, wider shoulder adapted to engage an end portion of the respective first and second suture retainers.

9. The instrument recited in claim 1, wherein the force distributing member includes first and second holes spaced apart at the first and second locations.

10. The instrument recited in claim 1, wherein the intermediate segment of the suture extends from the first location to the second location.

11. The instrument recited in claim 1, wherein the force distributing member has a washer-type configuration.

12. An instrument for delivering a transfascial suture, comprising:

a handle;

a drive mechanism housed in the handle;

an elongated shaft attached to and extending from the handle, the shaft including a distal end;

a first drive member and a second drive member, the first and second drive members being operatively coupled to the drive mechanism and moveable along respective drive paths from a retracted position not extending beyond the distal end of the shaft to an extended position beyond the distal end of the shaft in response to actuation of the drive mechanism;

a suture carried by the instrument, the suture defined by a first segment, a second segment and an intermediate segment between the first and second segments, each of the first and second suture segments formed by a single length of suture with a free end opposite the intermediate segment; and

a first suture retainer connected to the first segment and located in a first drive path, and a second suture retainer connected to the second segment and located in a second drive path, the first and second suture retainers being movable along the length of the respective first and second segments to selectively adjust the position of the first and second suture retainers along the first and second segments between the intermediate segment and the respective free ends, the first and second suture retainers carried by the instrument.

13. The instrument recited in claim 12, wherein the first suture and second suture retainers include an axial through-bore.

14. The instrument recited in claim 12, wherein the first and second suture retainers are configured to be carried by the first and second drive members as they move to the extended position.

15. The instrument recited in claim 12, wherein the first drive member and the second drive member include a pair of needles.

16. The instrument recited in claim 12, wherein each of the first and second suture retainers include a side body at which respective suture segments are connected.

17. The instrument recited in claim 16, wherein the suture segments are movingly connected to respective side bodies.

18. The instrument recited in claim 17, wherein each suture retainer includes an engagement feature for securing to the suture segment.

19. An instrument for delivering a transfascial suture, comprising:

a handle;

a drive mechanism housed in the handle;

an elongated shaft attached to and extending from the handle, the shaft including a distal end;

a first drive member and a second drive member, the first and second drive members being operatively coupled to the drive mechanism and moveable along respective drive paths from a retracted position not extending beyond the distal end of the shaft to an extended position beyond the distal end of the shaft in response to actuation of the drive mechanism, each of the first and second drive members including a one piece structure having a narrow tip and a proximal, wider shoulder;

a suture carried by the instrument, the suture defined by a first segment and a second segment; and

a first suture retainer connected to the first segment and located in a first drive path, and a second suture retainer connected to the second segment and located in a second drive path, the first and second suture retainers carried by the instrument, the first and second suture retainers configured to receive the tip and to be engaged by the shoulder of the first and second drive members to drive the first and second suture retainers along the respective first and second drive paths as the first and second drive members are moved to the extended position.

20. An instrument for delivering a transfascial suture, comprising:

a handle;

an elongated shaft extending from the handle and including a distal end;

a first drive member and a second drive member, the first and second drive members being moveable along respective drive paths to an extended position beyond the distal end of the shaft;

a suture carried by the instrument, the suture defined by a first segment and a second segment; and

a first suture retainer connected to the first segment and located in a first drive path, and a second suture retainer connected to the second segment and located in a second drive path, the first and second suture retainers carried by the instrument, the first and second suture retainers having a bore at a proximal end thereof adapted to receive the respective first and second drive members, the first and second retainers to be driven from the shaft and along the respective first and second drive paths by the first and second drive members as the first and second drive members are moved to the extended position, the first and second suture retainers including a closed-end pointed tip at a distal end thereof.