Tissue penetration device and method

• US 8,764,814 B2
• Filed: 06/27/2012
• Issued: 07/01/2014
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: Syntach AG
• Original Assignee: Synergio AG
• Inventors: Solem, Jan Otto
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/535,131
• Publication Number:
  US 20120283813A1
• Time in Patent Office: 734 Days
• Field of Search: 623/1.15, 623/1.36, 606/108
• US Class Current: 623/1.14
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A medical device for canalization of a tissue comprises a radially expandable and crimpable or collapsible substantially tubular member that has a rear end, a front end, and a pattern of struts or a mesh of wires arranged in-between the rear end and the front end, arranged around an interior of the device. The tubular member has extensions, which are arranged towards the interior of the device in a first state of the device, and towards an exterior of the medical device in a second state of the device, wherein the second state of the medical device is the tubular member turned inside out. During storage, the device is restrained in a delivery catheter in the second state. During delivery the device turns outside in and digs into the tissue to create a channel therein, thus preventing or fixating debris or other matter to spread from the channel.

Claims

1. A medical device configured for canalization of a tissue of a body portion by penetration thereof, said medical device comprising:

a radially expandable and crimpable substantially tubular member having a front end, a rear end, and a pattern of struts or a mesh of wires arranged in-between said front end and said rear end, arranged around an interior of said medical device, said tubular member having extensions that are arranged towards said interior of said medical device in a first state of said medical device, and wherein

said tubular member in a second state of said medical device has been turned inside out and said extensions are arranged towards an exterior of said medical device in said second state of said medical device,

said medical device is configured for placement at a target site in said tissue and to penetrate said tissue at said target site, and

said medical device is configured to spontaneously transition from said second state to said first state at said target site.

2. The medical device according to claim 1, wherein said device is made of a shape memory material.

3. The medical device according to claim 2, wherein:

said medical device is made of Nitinol,

said first state of said device is a heat set memory shape of said device formed at a heat setting temperature,

said device in said second state has a shape that is formed at a temperature substantially lower than said heat setting temperature, and

a temperature at which said device returns to its heat set memory shape is approximately a body temperature of a mammal.

4. The medical device according to claim 1, wherein said medical device is configured to be arranged in said second state prior to or during the delivery thereof to said target site and restrained in a restraining unit.

5. The medical device according to claim 4, wherein said medical device and said restraining unit are arranged to prevent said spontaneous transition of said medical device from said second state to said first state until at least a partial removal of said restraining unit from the device.

6. The medical device according to claim 1, wherein said extensions have sharp edges in a front thereof, configured for a cutting action in said tissue.

7. The medical device according to claim 6, wherein said extensions have a shape of spikes, loops, triangles, and/or blades.

8. The medical device according to claim 1, wherein said tubular member has an expandable balloon attached at said front end, which front end is configured to be arranged proximally during delivery and distally after penetration into said tissue, such that said balloon is arranged to expand said substantially tubular member upon inflation.

9. The medical device according to claim 8, wherein said balloon is attached at said front end in such a manner that it automatically detaches from said medical device towards an end of said transition from said second state to said first state.

10. The medical device according to claim 1, wherein said tubular member has a guide wire attached at said front end, which front end is configured to be arranged proximally during delivery and distally after penetration into said tissue.

11. The medical device according to claim 10, wherein said guide wire is attached at said front end in such a manner that it automatically detaches from said medical device towards an end of said transition from said second state to said first state.

12. The medical device according to claim 1, wherein said tubular member has a graft fixed at said front end, which front end is configured to be arranged proximally during delivery and distally after penetration into said tissue.

13. The medical device according to claim 1, wherein said medical device comprises a cover sheet arranged thereon on its inside and/or a cover sheet arranged thereon on its outside.

14. The medical device according to claim 1, wherein said device is configured to recanalize an occluded site of a lumen in said body portion.

15. The medical device according to claim 1, wherein said medical device is configured to pull itself into said tissue.

16. The medical device according to claim 15, wherein said medical device is configured to pull itself out of a delivery catheter.

17. The medical device according to claim 1, wherein said medical device is steerable by means of a bent delivery catheter or a delivery catheter with a manipulatably bendable tip.

18. The medical device according to claim 1, wherein said medical device is configured to foreshorten said tissue over time by a growth in device diameter and thereby shortening the length of the device after implant.

19. The medical device according to claim 1, wherein said medical device is adapted for trans-catheter delivery to said target site.

20. The medical device according to claim 19, wherein said medical device is configured to pull itself out of a delivery catheter.