Suturing devices and methods

• US 9,370,353 B2
• Filed: 03/08/2013
• Issued: 06/21/2016
• Est. Priority Date: 09/01/2010
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fortson, Aaron M., Roorda, Wouter E.
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US13/791,858
• Publication Number:
  US 20130190781A1
• Time in Patent Office: 1,201 Days
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers

Abstract

A surgical device for suturing body lumen is described, as well as methods for suturing tissue employing the surgical device. The device can include a body having a shaft and a foot for insertion into an opening in a body lumen. The device can include tissue ports between configured to receive tissue surrounding the opening in the body lumen. The foot can include a suture secured to needle capture devices. The device can include needles that can be advanced through tissue and into the needle capture devices. The needle capture devices can then be withdrawn, thereby harvesting the suture, which can then be used to close the opening in the body lumen.

Claims

1. A suturing device configured to close an opening in a body lumen, the suturing device comprising:

a shaft having a distal end and a proximal end, the shaft comprises a plurality of leafs that define the distal end of the shaft, the leafs being configured to flex outward relative to a center axis of the shaft in response to a force applied to the leafs;

a first needle lumen disposed within the shaft, the first needle lumen terminating at a first needle exit opening at the distal end of the shaft;

a second needle lumen disposed within the shaft, the second needle lumen terminating at a second needle exit opening at the distal end of the shaft;

a guide member slidably located within the shaft and extending past the distal end of the shaft;

a foot selectively coupled to the guide member, a proximal end of the foot being positioned proximally to the distal end of the shaft;

a first needle capture device removably secured to the foot;

a second needle capture device removably secured to the foot; and

at least one length of suture secured to the foot, the at least one length of suture having a first end secured to the first needle capture device and a second end secured to the second needle capture device.

2. The suturing device of claim 1, wherein:

the distal end of the shaft has an tapered cavity formed therein; and

a proximal end of the foot has a tapered shape configured to fit into the tapered cavity in the distal end of the shaft in a manner that the foot applies force to the leafs to flex the leafs outward.

3. The suturing device of claim 2, wherein the proximal end of the foot has a stop surface configured to contact a corresponding portion of the tapered cavity in the distal end of the shaft.

4. The suturing device of claim 3, wherein the stop surface and the taper of the tapered cavity and the tapered shape of the foot determine a predetermined position of the flexed leafs.

5. The suturing device of claim 1, wherein:

at least a portion of the first needle lumen is associated with a first leaf of the plurality of leafs; and

at least a portion of the second needle lumen is associated with a second leaf of the plurality of leafs.

6. The suturing device of claim 1, further comprising a dial adjustment located in the shaft, the dial adjustment being configured to apply force onto the leafs to flex the leafs outward.

7. The suturing device of claim 6, wherein the dial adjustment further comprises:

a threaded rod that is threaded into a threaded channel of the shaft; and

a wedge coupled to the threaded rod, the wedge being configured to apply force onto proximal ends of the leafs to flex the leafs outward.

8. The suturing device of claim 1, wherein the shaft further comprises a plurality of slots that form the leafs.

9. The suturing device of claim 1, further comprising a first needle and a second needle configured to engage respective first and second needle capture devices.

10. The suturing device of claim 1, wherein the foot is removably coupled to the guide member.

11. The suturing device of claim 1, wherein the foot further comprises one or more tissue ports configured to accept tissue surrounding the opening in the body lumen.

12. The device of claim 1, wherein a distal end of the foot has a substantially conical shape.

13. A suturing device configured to close an opening in a body lumen, the suturing device comprising:

a shaft having a distal end and a proximal end, the shaft comprises a plurality of leafs that define the distal end of the shaft, the leafs being configured to flex outward relative to a center axis of the shaft in response to a force applied to the leafs;

a first needle lumen disposed within the shaft, the first needle lumen terminating at a first needle entrance opening at the distal end of the shaft;

a second needle lumen disposed within the shaft, the second needle lumen terminating at a second needle entrance opening at the distal end of the shaft;

a guide member slidably positioned within the shaft and extending past the distal end of the shaft, the guide member having a first needle and a second needle, the first and second needles having piercing ends;

a length of suture having a first and second ends thereof secured to the first and second needles; and

a foot coupled to the guide member, the foot having a first needle connector lumen and a second needle connector lumen, the first and second needle connector lumens being configured to guide the first and second needles out of the guide member and into the first and second entrance openings in the shaft.

14. The suturing device of claim 13, wherein:

the distal end of the shaft has a tapered cavity formed therein; and

a proximal end of the foot has a tapered shape configured to fit into the tapered cavity in the distal end of the shaft in a manner that the foot applies force to the leafs to flex the leafs outward.

15. The suturing device of claim 13, wherein the foot further comprises one or more tissue ports configured to accept tissue surrounding the opening in the body lumen.

16. A method of closing an opening in a body lumen, the method comprising:

inserting a guide member of a suturing device through the opening and into the body lumen;

inserting a foot of the suturing device into the opening and capturing tissue surrounding the opening in one or more tissue ports of the foot;

adjusting a shaft of the suturing device in a manner that needle exit openings located in the shaft correspond with needle capture devices located in the foot, the shaft comprises a plurality of leafs that define a distal end of the shaft, the leafs being configured to flex outward relative to a center axis of the shaft in response to a force applied to the leafs;

passing a plurality of needles through the shaft, out of the needle exit openings, through the tissue surrounding the opening, and into corresponding needle capture devices; and

retrieving the plurality of needles together with the corresponding needle capture devices, thereby passing a length of suture attached to the needle capture devices through the tissue surrounding the opening.

17. The method of claim 16, wherein adjusting a shaft of the suturing device in a manner that needle exit openings located in the shaft correspond with needle capture devices located in the foot comprises flexing outward a plurality of leafs comprising a distal end of the shaft.

18. The method of claim 17, wherein flexing outward the plurality of leafs comprises pressing a tapered proximal end of the foot into a tapered cavity in the distal end of the shaft.