Ligature and suture device for medical application, ligature and suture system for medical application, and ligaturing and suturing method for medical application

• US 7,704,261 B2
• Filed: 04/05/2005
• Issued: 04/27/2010
• Est. Priority Date: 04/07/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Olympus Corporation
• Original Assignee: Olympus Corporation, Pankaj Jay Pasricha
• Inventors: Kawashima, Koichi, Kimura, Koh, Onuki, Yoshio, Pasricha, Pankaj Jay, Miyamoto, Satoshi, Suzuki, Takayuki, Sakamoto, Yuji
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/099,303
• Publication Number:
  US 20050251153A1
• Time in Patent Office: 1,848 Days
• Field of Search: 606/139, 606144-146, 623/2.11
• US Class Current: 606/139
• 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 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 2017/0488 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 2017/2905 flexible
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

A ligature and suture device for medical application that ligatures or sutures biomedical tissue that has been suctioned by a suction device using a suturing member. The ligature and suture device includes an insertion portion having a lumen into which an endoscope can be inserted, and a distal end portion that is connected to the lumen and in which at least one side aperture is provided, at least one hollow needle that is able to support inside itself the suturing member, and that is placed inside the insertion portion such that a tip of the hollow needle is able to move between a first position, which is on a base end side of the side aperture, and a second position, which is on a distal end side of the side aperture, an operating section that performs an operation to move the needle, and at least one pledget that can be penetrated by the needle, and that is placed in a vicinity of the distal end of the side aperture so as to be freely removable from the distal end portion.

Claims

1. A ligature and suture device for medical application that ligatures or sutures biomedical tissue that has been suctioned by a suction device using a suturing member, the ligature and suture device comprising:

an insertion portion having a lumen into which an endoscope can be inserted, and a distal end portion that is connected to the lumen and in which at least one side aperture is provided;

at least one hollow needle that is able to support inside itself the suturing member, and that is placed inside the insertion portion such that a tip of the hollow needle is able to move between a first position, which is on a base end side of the side aperture, and a second position, which is on a distal end side of the side aperture;

an operating section that performs an operation to move the needle; and

at least one pledget that can be penetrated by the needle, and that is placed in the distal end portion and closer to a tip of the distal end portion than the side aperture, so as to be freely removable from the distal end portion,

the pledget has a semicircular shape, having a circular arc portion, and

wherein the suturing member includes a string member and a holding member being provided at a distal end of the string member and holds the pledget against the biomedical tissue,

wherein a slit into which the pledget can be press-inserted is provided so as to open onto a side surface of the distal end portion between the side aperture and the second position, and

wherein, the pledget and the slit of the distal end portion are configured so that, when the pledget is press-inserted into the slit, the circular arc portion of the pledget is held by the distal end portion at the slit.

2. The ligature and suture device for medical application according to claim 1, wherein the pledget is placed between the distal end of the side aperture and the second position on a movement path of the needle.

3. The ligature and suture device for medical application according to claim 1, further comprising a protective member that protects a placement state of the pledget when the endoscope that has been inserted into the lumen is being operated.

4. The ligature and suture device for medical application according to claim 3, wherein the protective member is placed in the distal end portion.

5. The ligature and suture device for medical application according to claim 4, wherein the protective member is a restricting member that restricts contact between the endoscope that has been inserted into the lumen and the pledget.

6. The ligature and suture device for medical application according to claim 3, wherein the protective member is placed on the pledget.

7. The ligature and suture device for medical application according to claim 1, further comprising a distal end side needle guide portion that is placed further to the base end side of the distal end portion compared to the pledget, and that guides a distal end of the needle to the pledget.

8. The ligature and suture device for medical application according to claim 1, wherein a reinforcing portion that increases a rigidity of the distal end portion is provided in the distal end portion between at least the first position and the second position.

9. The ligature and suture device for medical application according to claim 1, wherein a reinforcing portion that increases a rigidity of the distal end portion is provided in the distal end portion between at least the first position and the distal end side needle guide portion.

10. The ligature and suture device for medical application according to claim 1, wherein

the insertion portion is provided with a pledget anchoring portion that anchors the pledget such that the pledget can be freely removed and anchored again, and

the pledget anchoring portion is formed such that, when the pledget is being moved, at least a portion of the pledget can be removed before the pledget arrives at a distal end of the side aperture, and the pledget anchoring portion is placed a predetermined distance apart from a distal end of the side aperture.

11. The ligature and suture device for medical application according to claim 10, wherein

the pledget anchoring portion is formed as a slit that is placed in the insertion portion, and

taking a point that is punctured by the needles when the pledget is anchored in the slit as a needle puncture point, then if the shortest distance from an edge portion of the pledget to the needle puncture point is taken as D, and if the shortest distance from the slit to the needle puncture point is taken as “

d”

, then the predetermined distance L is determined using a Formula;

L≧

(D² −

d²)^1/2.

12. The ligature and suture device for medical application according to claim 1, further comprises jaw portions that are placed on a side surface of the slit, and that protrude gradually towards a terminal end side of the slit.

13. The ligature and suture device for medical application according to claim 1, further comprises a variable member that alters at least a portion of the width of the slit.

14. The ligature and suture device for medical application according to claim 13, wherein the variable member is provided with an elastic member that is placed on the side surface on the side aperture side of the slit and that is able to make contact with the pledget.

15. The ligature and suture device for medical application according to claim 1, further comprising:

a pledget supporting portion that supports the pledget, and that is provided integrally with the distal end portion, and that is able to change the pledget from being aligned parallel to the needle to being aligned in a direction in which it can be pierced by the needle; and

a deforming device that supplies deforming force to the pledget supporting portion.

16. The ligature and suture device for medical application according to claim 15, wherein the pledget supporting portion is provided integrally with the distal end portion, and the deforming device is the suction device that is able to place the interior of the distal end portion under negative pressure.

17. The ligature and suture device for medical application according to claim 15, wherein the pledget supporting portion is provided integrally with the distal end portion, and the deforming device is a wire member having flexibility.

18. A ligature and suture system for medical application, comprising:

the ligature and suture device for medical application according to claim 1; and

an endoscope having the suction device that can be inserted into the lumen.

20. The ligature and suture device for medical application according to claim 1, wherein the pledget is provided in the distal end portion at least when the biomedical tissue is suctioned.

19. A ligature and suture method for medical application that ligatures or sutures biomedical tissue that has been suctioned by a suction device using a suturing member,

the suturing member includes a string member and a holding member, the holding member being provided at a distal end of the string member and holds a semicircular shaped pledget against the biomedical tissue, and

the ligature and suture method uses an insertion portion having a lumen into which the endoscope can be inserted, and a distal end portion that is connected to the lumen and in which at least one side aperture is provided,

the ligature and suture method comprising:

a pledget holding process in which the pledget is press-inserted into a slit provided at the distal end portion, holding a circular arc portion of the pledget by the slit;

a suction process in which an endoscope is inserted into the insertion portion, and the biomedical tissue is suctioned from the side aperture into the distal end portion;

an insertion process in which at least one hollow needle that is able to support inside itself the suturing member, and that is placed inside the insertion portion such that a tip of the hollow needle is able to at least move between a first position, which is on a base end side of the side aperture, and a second position, which is on a distal end side of the side aperture is inserted into the biomedical tissue and into the pledget that is placed in the distal end portion and between the distal end of the side aperture and the second position on a movement path of the needle so as to be freely removable from the distal end portion;

a process in which the holding member of the suturing member is pushed out from inside the needle to the distal side of the pledget; and

a process in which suturing or ligaturing is performed using the suturing member by withdrawing the needle from the biomedical tissue.