Clip devices and methods of delivery and deployment

• US 9,060,779 B2
• Filed: 08/03/2011
• Issued: 06/23/2015
• Est. Priority Date: 08/10/2010
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Martinez, Michelle D.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/197,497
• Publication Number:
  US 20120041455A1
• Time in Patent Office: 1,420 Days
• Field of Search: 606/139, 606/142, 606/143, 606/151, 606/157
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery

Abstract

The present embodiments provide systems and methods for deploying at least one clip device. In a first embodiment, the system comprises a first clip device having first and second arms. The first clip device and an associated sliding ring are configured to be selectively advanced through a lumen of an inner catheter. Selective positioning of an outer catheter over a distal region of the inner catheter causes a distal region of the inner catheter to bow radially inward to form a constriction that securely engages the sliding ring of the first clip device, thereby allowing for partial closure and repositioning of the first clip device. In an alternative embodiment, a delivery system includes a single catheter having a tapered distal region, such that upon ejection of the sliding ring from the distal end of the catheter, the sliding ring is dimensioned to abut the distal end of the catheter. In any of the embodiments, multiple clips may be sequentially loaded and deployed using the delivery systems. Various clip designs and a loading cylinder are also disclosed.

Claims

1. A system for deploying at least one clip device, the system comprising:

a first clip device having first and second arms, wherein distal ends of the first and second arms tend to be spaced apart from each other when the first clip device is in an open state, and wherein the distal ends of the first and second arms are adjacent to each other when the first clip device is in a closed state;

a sliding ring being movable between a first position when the first clip device is in the open state and a second position to hold the first and second arms of the first clip device in the closed state;

an inner catheter having a lumen, wherein the first clip device and the sliding ring are configured to be selectively advanced through the lumen of the inner catheter; and

an outer catheter having a lumen, wherein the inner catheter is configured for longitudinal movement with respect to the lumen of the outer catheter,

wherein selective positioning of the outer catheter over a distal region of the inner catheter causes the distal region of the inner catheter to bow radially inward to form a constriction that selectively engages the sliding ring of the first clip device using a friction fit, so that the sliding ring does not move either proximally or distally.

2. The system of claim 1, wherein the first and second arms of the first clip device are movable longitudinally relative to the sliding ring while the sliding ring is engaged by the constriction of the inner catheter, to permit selective movement of the first and second arms between the open state and a partially closed state.

3. The system of claim 1, further comprising at least one wedge member disposed at the distal region of the inner catheter, wherein the outer catheter is configured to selectively engage the wedge member to form the constriction when the outer catheter is positioned over the distal region of the inner catheter.

4. The system of claim 3, wherein the distal region of the inner catheter comprises at least one slit formed in a distal end of the inner catheter, wherein the at least one slit facilitates movement of the distal region of the catheter in a radially inward direction.

5. The system of claim 1, wherein multiple clip devices are configured to be loaded in a sequential manner within the lumen of the inner catheter at the same time, and further are configured to be individually and selectively deployed from a distal end of the inner catheter.

6. The system of claim 5 further comprising:

a second clip device having first and second arms, wherein distal ends of the first and second arms tend to be spaced apart from each other when the second clip device is in an open state, and wherein the distal ends of the first and second arms are adjacent to each other when the second clip device is in a closed state; and

a stylet disposed for longitudinal movement within the lumen of the inner catheter,

wherein the second clip device is configured to be disposed within the lumen of the inner catheter at a location distal to the stylet during delivery, and wherein the first clip device is configured to be disposed in the lumen of the inner catheter at a location distal to the second clip device during delivery,

wherein distal advancement of the stylet is adapted to cause distal advancement of the first and second clip devices to selectively deploy the first clip device and, subsequently, selectively deploy the second clip device.

7. The system of claim 6 wherein the first clip device comprises a proximal retainer adapted to securely engage the distal ends of the first and second arms of the second clip device within the lumen of the inner catheter, wherein the proximal retainer comprises a continuous loop formed by proximal ends of the first and second arms of the first clip device.

8. The system of claim 6 wherein proximal ends of the first and second arms of the first clip device are joined together by a proximal securement member, and wherein a proximal retainer is coupled to the proximal securement member and configured for engagement with the distal ends of the first and second arms of the second clip device within the lumen of the inner catheter.

9. A system for deploying at least one clip device, the system comprising:

a first clip device having first and second arms, wherein distal ends of the first and second arms are biased towards an open state in which they are spaced apart from each other, and wherein the distal ends of the first and second arms are adjacent to each other when the first clip device is in a closed state;

a sliding ring being movable between a first position when the first clip device is in the open state and a second position to hold the arms of the first clip device in the closed state; and

a catheter having proximal and distal ends, a lumen extending therebetween, and a tapered distal region, wherein the catheter comprises a first inner diameter at a location proximal to the tapered distal region, and further has a second inner diameter at the distal end, wherein the second inner diameter is less than the first inner diameter,

wherein the sliding ring comprises an outer diameter that is less than the first inner diameter of the catheter and greater than the second inner diameter of the catheter,

wherein the tapered distal region of the catheter is integral to the catheter, is directly adjacent to the first clip device in a delivery state, and is flexible such that application of a predetermined distally-oriented force imposed by the sliding ring ejects the sliding ring from the distal end of the catheter, and

wherein there is no outer catheter surrounding the tapered distal region of the catheter.

10. The system of claim 9 wherein, upon ejection of the sliding ring from the distal end of the catheter, the sliding ring is dimensioned to abut the distal end of the catheter.

11. The system of claim 10 wherein, upon ejection of the sliding ring from the distal end of the catheter, proximal retraction of the first and second arms of the first clip device relative to the sliding ring moves the first clip device between the open and closed states.

12. The system of claim 9 wherein the tapered distal region of the catheter comprises at least one slit formed in the distal end of the catheter, wherein the at least one slit facilitates movement of the tapered distal region of the catheter in a radially outward direction.

13. The system of claim 9 wherein multiple clip devices are configured to be loaded in a sequential manner within the lumen of the catheter at the same time, and further are configured to be individually and selectively deployed from the distal end of the catheter.

14. The system of claim 13 further comprising:

a second clip device having first and second arms, wherein distal ends of the first and second arms tend to be spaced apart from each other when the second clip device is in an open state, and wherein the distal ends of the first and second arms are adjacent to each other when the second clip device is in a closed state; and

a stylet disposed for longitudinal movement within the lumen of the catheter,

wherein the second clip device is configured to be disposed in the lumen of the catheter at a location distal to the stylet during delivery, and wherein the first clip device is configured to be disposed in the lumen of the catheter at a location distal to the second clip device during delivery,

wherein distal advancement of the stylet is adapted to cause distal advancement of the first and second clip devices to selectively deploy the first clip device and, subsequently, selectively deploy the second clip device.

15. The system of claim 14, wherein the first clip device comprises a proximal retainer adapted to securely engage the distal ends of the first and second arms of the second clip device within the lumen of the catheter, wherein the proximal retainer is disposed at a location proximal to the sliding ring, and wherein the proximal retainer is configured to be retained within the lumen of the catheter when the sliding ring is ejected distal to the catheter.

16. The system of claim 15, wherein the proximal retainer comprises a continuous loop formed by proximal ends of the first and second arms of the first clip device.

17. A system for deploying at least one clip device, the system comprising:

a first clip device having first and second arms, wherein distal ends of the first and second arms tend to be spaced apart from each other when the first clip device is in an open state, and wherein the distal ends of the first and second arms are adjacent to each other when the first clip device is in a closed state;

a sliding ring being movable between a first position when the first clip device is in the open state and a second position to hold the first and second arms of the first clip device in the closed state;

an inner catheter having a lumen, wherein the first clip device and the sliding ring are configured to be selectively advanced through the lumen of the inner catheter; and

an outer catheter having a lumen, wherein the inner catheter is configured for longitudinal movement with respect to the lumen of the outer catheter,

wherein selective positioning of the outer catheter over a distal region of the inner catheter causes the distal region of the inner catheter to bow radially inward to form a constriction that selectively engages the sliding ring of the first clip device using a friction fit,

wherein the sliding ring has first and second ends, and the constriction engages the sliding ring between the first and second ends.

18. The system of claim 17, wherein the first and second arms of the first clip device are movable longitudinally relative to the sliding ring while the sliding ring is engaged by the constriction of the inner catheter, to permit selective movement of the first and second arms between the open state and a partially closed state.

19. The system of claim 17, further comprising at least one wedge member disposed at the distal region of the inner catheter, wherein the outer catheter is configured to selectively engage the wedge member to form the constriction when the outer catheter is positioned over the distal region of the inner catheter.

20. The system of claim 19, wherein the distal region of the inner catheter comprises at least one slit formed in a distal end of the inner catheter, wherein the at least one slit facilitates movement of the distal region of the catheter in a radially inward direction.