Apparatus and method for tissue adhesion

• US 9,138,233 B2
• Filed: 11/03/2014
• Issued: 09/22/2015
• Est. Priority Date: 03/17/2011
• Status: Active Grant

• Current Assignee: Microkoll, Inc
• Original Assignee: Micokoll Inc.
• Inventors: Anderson, Steven Craig
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US14/531,656
• Publication Number:
  US 20150051708A1
• Time in Patent Office: 323 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 : End-to-end connections
• CPC Class Codes: A61B 2017/12063 : electrolytically detachable
• CPC Class Codes: A61B 2017/12072 : the heat created by laser light
• CPC Class Codes: A61B 2017/1209 : detachable by electrical current or potential, e.g. electroactive polymer
• CPC Class Codes: A61F 2/0063 : Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/848 : having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/0081 : directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2013/00357 : implanted wound fillings or covers
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

An array of a plurality of shape memory material microposts have a proximal end configured to be secured to a substrate with a tissue penetrating distal end. The microposts further have a deployment state with the microposts in a substantially straightened configuration with a substantially smooth and continuous outer surface which is substantially parallel to adjacent microposts and an engaged state wherein at least a section of the microposts assume a configuration that is not substantially parallel to adjacent microposts or is not substantially straight with a substantially smooth and continuous outer surface so as to mechanically capture tissue adjacent thereto.

Claims

1. A tissue adhesion device, comprising:

a substrate having a contact surface; and

an array of microposts extending from the contact surface of the substrate, said microposts fabricated from a shape memory material and having a proximal end secured to the substrate and having a sharpened tissue penetrating distal end, each micropost having a deployment state with the microposts in a substantially straightened configuration extending substantially perpendicular from the substrate and substantially parallel to adjacent microposts during penetration of tissue and an engaged state activated through shape memory transition after penetration wherein a distal section of the micropost engages to mechanically capture tissue adjacent thereto and said microposts are no longer substantially parallel to adjacent microposts and no longer in a straightened configuration.

2. The tissue adhesion device as defined in claim 1 wherein in the engaged state the distal end of each micropost has undergone a shape memory transition to be curved back such that a longitudinal axis of the distal end is at an angle of about 45 degrees to about 180 degrees from a nominal longitudinal axis of the micropost in the engaged state.

3. The tissue adhesion device as defined in claim 1 wherein a radius of curvature is established in a distal section through shape memory transition to the engaged state of about 100 percent to about 50 percent of the axial length of the respective microposts in the deployment state.

4. The tissue adhesion device as defined in claim 1 wherein a distal section of each micropost assumes a corkscrew configuration through shape memory transition to the engaged state to mechanically capture tissue adjacent thereto in the deployed state.

5. The tissue adhesion device as defined in claim 1 wherein the shape memory material is selected from the set of shape memory polymers and shape memory alloys.

6. The tissue adhesion device as defined in claim 5 wherein the shape memory material is a polymer selected from the set of polyurethane, polystyrene, polynorbornene or hydrogels.

7. The tissue adhesion device as defined in claim 5 wherein the shape memory material is NickelTitanium.

8. A tissue adhesion system comprising:

an elastically expandable substrate;

an array of microposts extending from the external surface of the substrate, said microposts fabricated from a shape memory material and having a proximal end secured to the substrate and having a sharpened tissue penetrating distal end with a deployment state with the microposts in a substantially straightened configuration substantially perpendicular to the substrate and substantially parallel to adjacent microposts during penetration of tissue and an engaged state activated through shape memory transition after penetration wherein a distal section of the micropost engages to mechanically capture tissue adjacent thereto and said microposts are no longer substantially parallel to adjacent microposts and no longer in a straightened configuration.

9. The tissue adhesion system as defined in claim 8 wherein the elastically expandable substrate is a balloon.

10. The tissue adhesion system as defined in claim 9 further comprising a catheter shaft removably attached to the substrate for inflation and deflation of the balloon substrate.

11. The tissue adhesion system as defined in claim 9 wherein the balloon substrate includes an internal surface which is self adhering upon deflation.

12. The tissue adhesion system as defined in claim 11 wherein the implantable device is a stent.

13. The tissue adhesion system as defined in claim 8 wherein the elastically expandable substrate is a tube.

14. The tissue adhesion system as defined in claim 8 wherein the elastically expandable substrate is attached as a coating on an implantable device.

15. A method for tissue adhesion comprising

providing a substrate having a contact surface;

and

forming an array of microposts extending from the contact surface of the substrate, said microposts fabricated from a shape memory material and having a proximal end secured to substrate, a sharpened tissue penetrating distal end;

deploying the microposts by penetrating into tissue for a desired procedure in a substantially straightened configuration substantially perpendicular to the substrate and substantially parallel to adjacent microposts; and

,

engaging the microposts by activation of the shape memory material after penetration wherein a distal section of the micropost mechanically captures tissue adjacent thereto and said microposts are no longer substantially parallel to adjacent microposts and no longer in a straightened configuration.

16. The method for tissue adhesion as defined in claim 15 wherein the desired procedure is an anastomosis and the substrate provided is a flexible tube, the step of deploying comprises

inserting the flexible tube into both sides of an anastomosis connection;

and

advancing the tissue penetrating distal ends of an array of microposts extending from and secured to a contact surface of the outer surface of the flexible tube into target tissue in both sides of the anastomosis connection.

17. The method for tissue adhesion as defined in claim 15 wherein the desired procedure is an insertion of an implantable device, the step of providing a substrate comprises attaching the substrate as a coating on the implantable device and the step of deploying includes

inserting the implantable device in a target area adjacent tissue to be engaged and

advancing the tissue penetrating distal ends of the array of microposts extending from and secured to the coating on the outer surface of the implantable device into target tissue.

18. The method for tissue adhesion as defined in claim 17 wherein the implantable device is a stent.

19. The method for tissue adhesion as defined in claim 15 wherein the desired procedure is closure of a wound and the substrate is provided as a flexible balloon, the step of deploying comprising

inserting the balloon into a wound;

expanding the balloon such that the microposts are expanded radially outward towards the extent of the wound in the target tissue and the tissue penetrating tips of the microposts penetrate the target tissue;

and after the step of engaging, further comprising

collapsing the balloon to draw the wound closed.