Endovascular stapling apparatus and methods of use

• US 7,954,688 B2
• Filed: 04/15/2009
• Issued: 06/07/2011
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jelich, Damian, Sandstrom, Jeff, Argentine, Jeff, Meyer, Eric
• Primary Examiner(s): Smith; Scott A.
• Application Number:
  US12/424,261
• Publication Number:
  US 20100044410A1
• Time in Patent Office: 783 Days
• Field of Search: 227/19, 227/176.1, 227/175.1, 227/180.1, 227/179.1, 606/139, 606/153, 606/219, 606/151
• US Class Current: 227/176.1
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising

Abstract

An endovascular stapling apparatus for delivering a staple to a vessel of a patient, including a plurality of clips, a housing, and a rod. Each of the clips includes a bridge and legs that self-transition from a biased state to a natural state in which the legs each form a loop. The housing defines a channel and a window open to the channel. The clips are retained within the channel in the biased state. The rod is slidably disposed within the channel, selectively moves the clips toward and away from the window, and releases the clips from the window.

Claims

1. An endovascular stapling apparatus for delivering a staple to a vessel of a patient, the apparatus comprising:

a plurality of clips each including a bridge interconnecting opposing legs, the clips being configured to self-transition to a natural state in which the legs each form a loop from a biased state in which the legs are relatively straight as compared to the natural state;

an elongate housing defining a channel within which the clips are retained in the biased state, the housing forming a deployment window open to the channel; and

a deployment rod slidably disposed within the channel and configured to interface with the clips;

wherein the deployment rod is configured to selectively move at least one of the clips toward and away from the deployment window in response to a corresponding user-applied force such that each of the clips are consecutively releasable from the deployment window with movement of the deployment rod.

2. The apparatus of claim 1, wherein the deployment rod includes a distal segment positioned within the housing and a proximal segment extending proximal the housing, the apparatus further comprising:

an actuator connected to the proximal segment of the deployment rod;

wherein the device is configured such that a first force imparted upon the actuator causes the deployment rod to move distally relative to the housing, and a second force imparted upon the actuator causes the deployment rod to move proximally relative to the housing.

3. The apparatus of claim 1, further comprising:

a catheter forming a first lumen within which the deployment housing is disposed and forming an exit port open to the first lumen and aligned with the deployment window upon final assembly.

4. The apparatus of claim 3, wherein the catheter further includes a second lumen, the apparatus further comprising:

a guide wire slidably disposed within the second lumen.

5. The apparatus of claim 1, wherein the deployment rod forms a lateral notch defined by a proximal wall and a distal wall, and further wherein a width of the lateral notch between the distal and proximal walls is sized to selectively receive the bridge of one of the clips.

6. The apparatus of claim 5, wherein the distal wall is configured to transfer a pulling force from the deployment rod onto a first side of the corresponding bridge.

7. The apparatus of claim 6, wherein the proximal wall is configured to transfer a pushing force from the deployment rod onto a second side of the corresponding bridge.

8. The apparatus of claim 5, wherein the deployment rod forms a plurality of lateral notches, and further wherein individual ones of the clips are selectively retained within respective ones of the lateral notches.

9. The apparatus of claim 8, wherein upon final assembly of the apparatus, the plurality of lateral notches and the plurality of clips are distal the deployment window.

10. The apparatus of claim 5, wherein the deployment rod defines a shuttle surface proximal the notch and positioned upon final assembly to interface with the bridge of at least one of the clips, the shuttle surface including:

a leading segment adjacent the notch and forming the shuttle surface at a first radial distance relative to a center axis of the deployment rod;

a trailing segment proximal the leading segment and forming the shuttle surface at a second radial distance relative to the center axis, the second distance being less than the first distance; and

a ramp forming a transition of the shuttle surface between the leading and trailing segments.

11. The apparatus of claim 10, wherein with respect to a first clip positioned such that the corresponding bridge is within the notch, the channel is configured to permit movement of the first clip with sliding movement of the deployment rod.

12. The apparatus of claim 11, wherein with respect to a second clip positioned such that the corresponding bridge is along the trailing segment, the channel is configured to retain the second clip in a stationary position with sliding movement of the deployment rod.

13. The apparatus of claim 10, wherein the clips are configured such that when disposed within the channel, the corresponding bridge is radially biased toward the shuttle surface.

14. The apparatus of claim 10, wherein:

an outer surface of the leading segment forms a circle in transverse cross-section; and

an outer surface of the trailing segment forms an incomplete circle in transverse cross-section.

15. The apparatus of claim 10, wherein in an initial, loaded state of the apparatus:

a first one of the clips is positioned such that the corresponding bridge is captured within the notch; and

remaining ones of the clips are positioned such that the corresponding bridges are along the trailing segment.

16. The apparatus of claim 1, further comprising:

a biasing device associated with the housing, the biasing device including a linkage assembly comprising;

a distal link mounted to the housing,

a proximal link slidably connected to the housing, and

at least one intermediate link hingedly connected between the distal and proximal links,

wherein the linkage assembly is configured to radially extend and retract the intermediate link relative to the housing with sliding movement of the proximal link relative to the distal link.

17. An endovascular stapling apparatus for delivering a staple to a vessel of a patient, the apparatus comprising:

a plurality of clips each including a bridge interconnecting opposing legs, the clips being configured to self-transition to a natural state in which the legs each form a loop from a biased state in which the legs are relatively straight as compared to the natural state; and

a delivery instrument comprising;

an actuator,

a delivery assembly including;

a housing forming a channel and a deployment window open to the channel,

a deployment rod slidably disposed within the channel, the deployment rod including a proximal region connected to the actuator,

wherein the channel is sized to constrain the clips to the biased state and the deployment rod is configured to interface with the clips;

a catheter forming a lumen within which at least a portion of the housing is disposed,

an introducer extending distal the housing; and

a guide wire slidably associated with the instrument;

wherein in an initial, loaded state of the apparatus, the actuator is operable to repeatedly move the deployment rod relative to the housing in partially deploying, withdrawing, and fully deploying each of the clips from the deployment window.

18. A method of delivering a staple through a bodily lumen, the method comprising:

providing an endovascular stapling apparatus including;

a plurality of clips each including a bridge interconnecting opposing legs, the clips being configured to self-transition from a biased state in which the legs are relatively straight to a natural state in which the legs each form a loop,

a delivery assembly including;

a housing defining a channel within which the clips are retained in the biased state, and forming a deployment window open to the channel,

a deployment rod slidably disposed within the channel and configured to interface with the clips,

a catheter forming a lumen within which the housing is at least partially disposed;

delivering the delivery assembly into the bodily lumen;

positioning the deployment window at a target site of the bodily lumen;

proximally retracting the deployment rod relative to the housing to deploy a portion of a first clip from the deployment window;

evaluating a position of the partially deployed first clip relative to the bodily lumen;

distally advancing the deployment rod relative to the housing to at least partially withdraw the portion of the first clip back into the housing;

repositioning the delivery assembly relative to the bodily lumen; and

proximally retracting the deployment rod relative to the housing to fully deploy the first clip through the deployment window.

19. The method of claim 18, wherein repositioning the delivery assembly relative to the bodily lumen includes the first clip not contacting a structure of the bodily lumen.

20. The method of claim 18, further comprising:

repeatedly, proximally retracting and distally advancing the deployment rod relative to the housing to repeatedly, partially deploy the first clip from, and at least partially withdraw the first clip back into, the deployment window.

21. The method of claim 18, wherein following the step of fully deploying the first clip, the method further comprising:

proximally retracting the deployment rod relative to the housing to deploy a second clip from the deployment window.

22. The method of claim 21, wherein prior to deploying the first clip, the second clip is located distal the deployment window.

23. The method of claim 22, wherein the second clip slides proximally with the deployment rod during the step of proximally retracting the deployment rod to fully deploy the first clip.

24. The method of claim 22, wherein the second clip slides distally with the deployment rod during the step of distally advancing the deployment rod to at least partially withdraw the first clip back into the deployment window.

25. The method of claim 18, wherein following the step of fully deploying the first clip, the method further comprising:

proximally retracting the deployment rod relative to the housing to capture a second clip to the deployment rod;

distally advancing the deployment rod to move at least a portion of the second clip distally beyond the deployment window; and

proximally retracting the deployment rod to deploy the second clip from the deployment window.

26. The method of claim 25, wherein the second clip remains stationary relative to the housing during the step of proximally retracting the deployment rod to fully deploy the first clip.

27. The method of claim 25, wherein the housing and the second clip are configured such that when retained within the housing, the bridge of the second clip is naturally biased against the deployment rod.

28. The method of claim 27, wherein the deployment rod forms a notch for selectively capturing the bridge of the second clip.

29. The method of claim 28, wherein proximally retracting the deployment rod to fully deploy the first clip includes sliding the deployment rod to a first clip deployment position in which the notch is aligned with the deployment window, and further wherein the bridge of the second clip is outside of the notch in the first clip deployment position.

30. The method of claim 29, wherein the bridge of the second clip bears against the deployment rod in the first clip deployment position at a first radial elevation relative to a center axis of the deployment rod and further wherein proximally retracting the deployment rod to capture the second clip includes forcing the bridge of the second rod to a second radial elevation relative to the center axis, the second radial elevation being greater than the first radial elevation.

31. The method of claim 30, wherein forcing the bridge to the second radial elevation includes slidably engaging the bridge of the second clip along a ramp of the deployment rod.