Needle assembly for tissue manipulation

• US 7,621,925 B2
• Filed: 09/30/2004
• Issued: 11/24/2009
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Ewers, Richard C., Rothe, Chris
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US10/955,243
• Publication Number:
  US 20050251161A1
• Time in Patent Office: 1,881 Days
• Field of Search: 606/139, 606/144, 606/145, 606/148, 606/213, 606/215, 606/222, 606/232
• US Class Current: 606/139
• 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 17/0487 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• 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 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue

Abstract

Needle assemblies for tissue manipulation are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. A needle deployment assembly is deployable through the tissue manipulation assembly via a handle assembly, through the tubular member, and into or through tissue. An elongate pusher is translationally disposed within a sheath of the needle deployment assembly and can be urged distally for deploying an anchor assembly from the sheath distal end. The anchor assembly is positioned distally of the pusher within the sheath.

Claims

1. A needle assembly for use in forming a tissue fold, comprising:

a housing having a shuttle member enclosed within;

an elongate pusher attached to the shuttle member and extending from a distal end of the housing;

a tubular sheath having a first lumen adapted to receive the elongate pusher therethrough and having a proximal end which is attachable to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible distal region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is substantially transverse to the longitudinal axis;

an actuation member disposed on the housing, wherein articulation of the actuation member translates the elongate pusher longitudinally relative to the housing;

a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath;

at least one anchor positioned distally of the elongate pusher; and

a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members;

wherein said needle body has a first position in which the needle body is located outside of the space between said first and second extension members and a second position in which the needle body is located within the space between said first and second extension members.

2. The assembly of claim 1 wherein the housing comprises a cylindrically-shaped member.

3. The assembly of claim 1 wherein the housing defines at least one projection extending therefrom for retaining the needle assembly within a handle.

4. The assembly of claim 1 wherein the housing comprises an indicator which is indicative of a position of the shuttle member within the housing.

5. The assembly of claim 4 wherein the indicator comprises a translatable visual marker which is visible through a window defined along a length of the housing.

6. The assembly of claim 4 further comprising one or more gradations along a length of the housing.

7. The assembly of claim 1 wherein the elongate pusher is connected to the shuttle member.

8. The assembly of claim 1 wherein the elongate pusher is flexible.

9. The assembly of claim 1 wherein the shuttle member comprises a threaded member adapted to be linearly translated over a rotatable threaded shaft.

10. The assembly of claim 1 further comprising a lubricious lining or coating along an inner surface of the tubular sheath.

11. The assembly of claim 1 wherein the tubular sheath comprises a translucent material.

12. The assembly of claim 1 wherein the proximal end of the tubular sheath is adapted to be releasably attached to a distal end of the housing.

13. The assembly of claim 1 wherein a distal end of the tubular sheath is tapered.

14. The assembly of claim 1 wherein the actuation member is rotatably disposed on a proximal end of the housing.

15. The assembly of claim 1 wherein the at least one anchor has a low-profile delivery configuration when positioned within the tubular sheath and an expanded configuration when deployed from the tubular sheath.

16. The assembly of claim 1 wherein said at least one anchor comprises at least two anchors, and further comprising a length of suture between at least two of the anchors.

17. The assembly of claim 16 further comprising a locking mechanism adapted to slide uni-directionally over the suture in a direction towards the anchor.

18. An apparatus for forming a tissue fold, comprising;

a housing;

an elongate pusher extending from a distal end of the housing;

a tubular sheath having a flat lumen adapted to receive the elongate pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible dial region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis;

a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath;

at least one anchor positioned distally of the elongate pusher; and

a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members;

wherein said needle body has a first position in which the needle body is located outside of the space between mid first and second extension members and a second position in which the needle body is located within the space between mid first and second extension members.

19. An apparatus for forming a tissue fold, comprising;

a housing;

an elongate pusher extending from a distal end of the housing;

a tubular sheath having a first lumen adapted to receive the elongate, pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible distal region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis;

a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath;

at least one anchor positioned distally of the elongate pusher;

a tissue manipulation assembly comprising a first jaw and a second jaw configured to receive a tissue fold in a space located between said first and second jaws; and

a launch tube having a distal end that is pivotably attached to said first jaw, with said tubular sheath being slidably disposed within a launch tube lumen defined by said launch tube;

wherein said needle body has a first position in which the needle body is located within said launch tube lumen and a second position in which the needle body extends out of the launch tube lumen.