Device and method for through the scope endoscopic hemostatic clipping

• US 8,685,048 B2
• Filed: 04/16/2013
• Issued: 04/01/2014
• Est. Priority Date: 10/05/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Adams, Mark L., Durgin, Russell F., Turturro, Vincent, Grant, Justin, May, Norman, Sullivan, Roy H.
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US13/863,494
• Publication Number:
  US 20130231685A1
• Time in Patent Office: 350 Days
• Field of Search: 606/120, 606/139, 606/142, 606/143, 606/151, 606/157, 606/158, 606/213, 606/215, 241/15.F, 244/56, 245/37, 246/02
• US Class Current: 606/157
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/3916 Bone tissue
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety

Abstract

Medical device used to cause hemostasis of blood vessels using a clip arrangement delivered to a target region through an endoscope. Method for using the device to cause hemostasis of a blood vessel through an endoscope. Medical device including a reversibly closeable clip, a locking arrangement, a control wire, a sheath, and a handle with an actuating trigger. Through the endoscope, hemostatic clipping device that is fully reversible and lockable. Hemostatic clip that reversibly targets and clips bleeding ulcers.

Claims

1. A medical device, comprising:

a clip having first and second clip legs;

a control wire being operable both to open the clip legs and to close the clip legs;

a sheath enclosing the control wire;

a link coupling the control wire to the clip, the link being movable from a coupled configuration in which the clip is coupled to a distal end of the control wire to a released configuration in which first and second arms of the link are configured to move radially outward at an area of the sheath to release the control wire from the clip; and

an actuator coupled to the control wire, the control wire engageable by the actuator to move the control wire to open and close the clip legs and to move the link from the coupled configuration to the released configuration.

2. The medical device of claim 1, wherein the distal end of the control wire comprises an increased diameter portion having a substantially spherical cross section.

3. The medical device of claim 1, further comprising a lock sleeve surrounding a part of the clip so that, as the clip is drawn proximally thereinto, the clip legs are drawn toward one another, wherein the lock sleeve radially surrounds part of the first and second clip legs.

4. The medical device of claim 3, wherein before the clip is separated from the control wire, moving the sheath proximally relative to the control wire moves the clip out of the lock sleeve, opening the clip legs.

5. The medical device of claim 3, further comprising a lock arrangement for locking the clip within the lock sleeve with the first and second clip legs closed.

6. The medical device of claim 1, wherein a proximal tensile force applied to the clip via the control wire is opposed by a distal compressive force on the sheath, wherein the sheath is constructed to communicate the distal compressive force via the control wire when the control wire is coupled to the link.

7. The medical device of claim 1, wherein the clip legs are separated from one another by a spring member positioned therebetween and biased to urge the first and second clip legs away from one another.

8. The medical device of claim 1, wherein the link comprises the distal end of the control wire and the proximal end of the clip.

9. The medical device of claim 1, wherein the control wire is reversibly operable.

10. The medical device of claim 1, further comprising a lock pawl associated with the link that inhibits proximal movement of the link at a predetermined location.

11. The medical device of claim 1, wherein the first and second arms of the link are configured to automatically move radially outward at a relief area of the sheath when a tensile load is applied to the arms via the control wire due to resilience.

12. The medical device of claim 1, wherein a distal portion of the sheath is comprised of a rigid portion, wherein the first and second legs are configured to move radially inward when the clip is drawn proximally relative to the sheath due to a compressive force between one of (a) the rigid portion and the first and second legs and (b) the sheath and the first and second legs.

13. The medical device of claim 1, wherein the link is formed integrally with one of the clip and the control wire.

14. The medical device of claim 1, wherein the link is not formed integrally with the control wire or the clip.

15. A medical device, comprising:

a clip having first and second clip legs;

a control wire coupled to the clip, the control wire being movable relative to a sheath to open and close the clip legs, a distal end of the control wire received between legs of the clip;

the sheath enclosing a distal portion of the control wire, wherein the control wire is configured to release from the clip as the legs spread laterally away from the control wire; and

an actuator coupled to the control wire to move the control wire relative to the sheath and to release the control wire from the clip.

16. The medical device of claim 15, wherein the legs are formed integrally with the clip.

17. The medical device of claim 15, wherein the distal end of the control wire comprises an increased diameter portion having a substantially spherical cross section.

18. The medical device of claim 15, further comprising a lock sleeve surrounding a part of the clip so that, as the clip is drawn proximally thereinto, the clip legs are drawn toward one another, wherein the lock sleeve radially surrounds part of the first and second clip legs.

19. The medical device of claim 18, wherein before the clip is separated from the control wire, moving the sheath proximally relative to the control wire moves the clip out of the lock sleeve, opening the clip legs.

20. The medical device of claim 18, further comprising a lock arrangement for locking the clip within the lock sleeve with the first and second clip legs closed.

21. The medical device of claim 15, wherein a proximal tensile force applied to the clip via the control wire is opposed by a distal compressive force on the sheath, wherein the sheath is constructed to communicate the distal compressive force via the control wire when the control wire is coupled to a link, the link coupling the control wire to the clip and comprising the distal end of the control wire and the proximal end of the clip.

22. The medical device of claim 15, wherein the clip legs are separated from one another by a spring member positioned therebetween and biased to urge the first and second clip legs away from one another.

23. The medical device of claim 15, wherein the control wire is reversibly operable.

24. The medical device of claim 15, further comprising a lock pawl associated with a link coupling the control wire to the clip that inhibits proximal movement of the link at a predetermined location.

25. The medical device of claim 24, wherein first and second arms of the link are configured to automatically move radially outward at a relief area of the sheath when a tensile load is applied to the first and second arms via the control wire due to resilience.

26. The medical device of claim 15, wherein a distal portion of the sheath is comprised of a rigid portion and wherein the first and second legs are configured to move radially inward when the clip is drawn proximally relative to the sheath due to a compressive force between one of (a) the rigid portion and the first and second legs and (b) the sheath and the first and second legs.

27. The medical device of claim 25, wherein the link is formed integrally with one of the clip and the control wire.

28. The medical device of claim 15, wherein the link is not formed integrally with the control wire or the clip.

29. A method, comprising:

inserting a medical device comprising a clip having first and second clip legs, a control wire, a sheath enclosing the control wire and a proximal portion of the clip;

positioning the medical device at a desired deployment location;

moving the control wire distally relative to the sheath to deploy the first and second clip legs distally from the sheath;

adjusting a position of the clip so that target tissue is received between the first and second clip legs;

drawing the control wire proximally relative to the sheath to draw the clip into the sheath to receive the target tissue between the first and second clip legs;

applying a tensile force of at least a threshold level to the control wire to separate a separable link coupling the control wire to the clip.

30. The method of claim 29, further comprising:

the separation uncoupling the clip from the control wire and separating a capsule from the sheath to lock the clip over the coupled target tissue.