Apparatus and method for tissue adhesion

• US 8,906,046 B2
• Filed: 09/17/2009
• Issued: 12/09/2014
• Est. Priority Date: 09/20/2008
• Status: Active Grant

• Current Assignee: Microkoll, Inc
• Original Assignee: Microkoll, Inc
• Inventors: Anderson, Steven Craig
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US13/119,540
• Publication Number:
  US 20110172760A1
• Time in Patent Office: 1,909 Days
• Field of Search: 606/139, 606/151, 606/157, 606/158, 606/185, 606/192, 606/193, 606/194, 606/195, 606/213, 606/215, 606/216, 606/219, 606/220, 606/221, 623/1.14
• US Class Current: 606/151
• 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 17/08 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 (12) have a proximal end (10) configured to be secured to a substrate (14) with a tissue penetrating distal end (18). The microposts further have a deployment state with the microposts (12) 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 (12′) 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 including a proximal end secured to the substrate, a sharpened tissue penetrating distal end, with a deployment state in which each micropost is in a substantially straightened configuration with a smooth continuous outer surface and each micropost is substantially parallel to each other micropost in the array and substantially perpendicular to the substrate to penetrate target tissue, and an engaged state activated after penetration wherein a distal section of each micropost has undergone movement through a shape memory transition to assume a shape which differs from the shape of the microposts in the deployment state and which mechanically captures target tissue adjacent thereto.

2. The tissue adhesion device as defined in claim 1 wherein the distal end of each micropost is 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 in 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 (36) of each micropost is bulged in the engaged state so as to mechanically capture tissue adjacent thereto in the deployed state.

5. The tissue adhesion device as defined in claim 1 wherein a distal section (38) of each micropost assumes a corkscrew configuration in the engaged state to mechanically capture tissue adjacent thereto in the deployed state.

6. 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.

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

8. The tissue adhesion device as defined in claim 6 wherein the shape memory material is NickelTitanium.

9. A tissue adhesion as defined in claim 1 wherein the substrate comprises:

a pad having a tissue interface surface as the contact surface; and

,

the array of microposts extend from the tissue interface surface of the pad.

10. The tissue adhesion patch as defined in claim 9 wherein the array of microposts are integrally molded with a substrate on an interface surface to create a pad.

11. The tissue adhesion patch as defined in claim 9 wherein the shape memory material is a polymer selected from the set of polyurethane, polystyrene, polynorbornene or hydrogels.

12. The tissue adhesion patch as defined claim 9 wherein the shape memory material is NickelTitanium.

13. A tissue adhesion system comprising:

an elastically expandable substrate;

an array of microposts extending from the contact surface of the substrate, said microposts fabricated from a shape memory material and including a proximal end secured to the substrate, a sharpened tissue penetrating distal end with a deployment state in which each micropost is in a substantially straightened configuration with a smooth continuous outer surface and each micropost is substantially parallel to each other micropost in the array and substantially perpendicular to the substrate to penetrate target tissue, and an engaged state activated after penetration wherein a distal section of each micropost has undergone movement through a shape memory transition to assume a shape which differs from the shape of the microposts in the deployment state and which mechanically captures target tissue adjacent thereto.

14. 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, with a deployment state in which each micropost is in a substantially straightened configuration with a smooth continuous outer surface and each micropost is substantially parallel to each other micropost in the array and substantially perpendicular to the substrate to penetrate target tissue;

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

,

engaging the microposts after penetration by activation of the shape memory material wherein a distal section of the micropost undergoes movement through a shape memory transition to assume a shape which differs from the shape of the microposts in the deployment state and which mechanically captures tissue adjacent thereto.

15. The method for tissue adhesion as defined in claim 14 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.