Method and apparatus for clamping tissue layers and occluding tubular body structures

• US 10,398,445 B2
• Filed: 09/08/2017
• Issued: 09/03/2019
• Est. Priority Date: 01/11/2011
• Status: Active Grant

• Current Assignee: Amsel Medical Corporation
• Original Assignee: Amsel Medical Corporation
• Inventors: Miller, Arnold, Miller, Raanan, Lilach, Nir, Edelman, William
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/699,975
• Publication Number:
  US 20180021044A1
• Time in Patent Office: 725 Days
• Field of Search: 606158, 606213, 606215
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

Apparatus and methods for occluding hollow body structures, such as blood vessels, and for attaching tissue layers together by providing implantable elements on opposite sides of the structure or tissue layers and drawing the implants together to occlude the body structure and/or bring the tissue layers together. The implants are deliverable in a low profile configuration and self-expand to an enlarged configuration. The implantable elements are delivered by transfixing the body structure, then releasing the implants on opposite sides of the body structure and drawing the implants together to effect an occlusion or attachment. The implants are configured to apply oppositely directed forces to opposite surfaces of the tissue layers at alternate, circumferentially spaced locations and may constrain the tissue in a serpentine pattern or in a direct clamping pattern. The implants grip the tissue in a manner that defines a pressure zone about the transfixion aperture that prevents leakage from the aperture.

Claims

1. A method for clamping tissue layers together, each layer, prior to clamping, having an inwardly facing surface and an outwardly facing surface, the method comprising:

constraining the tissue layers together by applying oppositely directed forces to the outwardly facing surfaces of the tissue layers to urge the inwardly facing surfaces together, the forces being applied alternately at circumferentially spaced locations about a central location to constrain the tissue layers in a serpentine configuration that circumscribes the central location.

2. The method as defined in claim 1 wherein the tissue layers comprise the walls of a tubular or hollow anatomical structure.

3. The method as defined in claim 1 further comprising:

providing a first clamping member;

providing a second clamping member separate from the first clamping member;

deploying the first clamping member opposite and facing the outwardly facing surface of one of the layers;

thereafter deploying the second clamping member opposite and facing the outwardly facing surface of the other of the layers; and

drawing the first and second clamping members toward each other to apply the oppositely directed, circumferentially spaced forces to the layers.

4. The method as defined in claim 1 further comprising:

the tissue layers being naturally opposed with the inwardly facing surfaces facing each other;

the forces being applied in directions that are approximately perpendicular to the tissue layers.

5. The method as defined in claim 4 wherein the tissue layers comprise opposing walls of a tubular anatomical structure.

6. The method as defined in claim 1 further comprising:

forming an opening through the layers;

passing a distal clamping member through the opening to locate the distal clamping member distally of the layers;

locating a proximal clamping member proximally of the layers; and

drawing the proximal and distal clamping members together to constrain the layers.

7. A method for clamping tissue layers together, the layers comprising opposing portions of a tubular or hollow anatomical structure and where the clamping at least partially occludes the lumen of the anatomical structure, each layer, prior to clamping, having an inwardly facing layer and an outwardly facing layer, the method comprising:

constraining the tissue layers together by engagement with their outwardly facing surfaces to urge the inwardly facing surfaces together in a serpentine configuration and having at least three sequentially reversing bends, the serpentine configuration circumscribing an axis that is approximately perpendicular to the tissue layers.

8. The method as defined in claim 7 wherein the tissue layers comprise the walls of a tubular or hollow anatomical structure.

9. The method as defined in claim 7 further comprising:

providing a first clamping member;

providing a second clamping member separate from the first clamping member;

deploying the first clamping member opposite and facing the outwardly facing surface of one of the layers;

thereafter deploying the second clamping member opposite and facing the outwardly facing surface of the other of the layers; and

drawing the first and second clamping members toward each other to constrain the layers in a serpentine configuration having at least three sequentially reversing bends.

10. The method as defined in claim 7 further comprising:

forming an opening through the layers;

passing a distal clamping member through the opening to locate the distal clamping member distally of the layers;

locating a proximal clamping member proximally of the layers; and

drawing the proximal and distal clamping members together to constrain the layers.

11. A method for clamping together a tissue layer to another tissue or non-tissue layer, each layer, prior to clamping, having an inwardly facing surface and an outwardly facing surface, the method comprising:

with the inwardly facing surfaces facing each other, constraining the layers together by applying oppositely directed forces to the outwardly facing surfaces of the layers, the forces being applied alternately at circumferentially spaced locations about a central location to form the layers into a serpentine configuration that circumscribes the central location.

12. The method as defined in claim 11 further comprising:

forming an opening through the layers;

passing a distal clamping member through the opening to locate the distal clamping member distally of the layers;

locating a proximal clamping member proximally of the layers; and

drawing the proximal and distal clamping members together to constrain the layers.

13. A method for clamping a tissue layer to another tissue or non-tissue layer, each layer, prior to clamping, having an inwardly facing layer and an outwardly facing layer, the method comprising:

constraining the layers together by engagement with their outwardly facing surfaces to urge the inwardly facing surfaces together in a serpentine configuration and having at least three sequentially reversing bends, the serpentine configuration circumscribing an axis that is approximately perpendicular to the tissue layers.