Tissue penetration device and method

• US 8,216,261 B2
• Filed: 04/14/2008
• Issued: 07/10/2012
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: Syntach AG
• Original Assignee: Synergio AG
• Inventors: Solem, Jan Otto
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/595,568
• Publication Number:
  US 20100179633A1
• Time in Patent Office: 1,548 Days
• Field of Search: 623/1.23, 606/159, 606/167, 606/198
• US Class Current: 606/159
• 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 of a body portion by penetration thereof, a kit, a manufacturing method and a method of canalization are disclosed. The device is adapted for trans-catheter delivery to the body portion, and 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 method of tissue penetration and/or shaping of channels in tissue, or connections between tissue compartments in a body portion by means of a medical device for canalization thereof by penetration thereof, said method comprising:

delivering said medical device in a delivery catheter to said body portion;

pushing a rear end of said medical device initially out of a distal end of said delivery catheter, whereby said medical device turns around a distal end of said delivery catheter, expands, engages with said tissue, and pulls itself by means of its own force out of said delivery catheter, digging and/or cutting into said tissue and turning itself outside in, and advancing into said tissue.

2. The method according to claim 1, further comprising pushing on an outside end of said delivery catheter to ensure that said distal end of said delivery catheter follows the medical device inside said tissue.

3. The method according to claim 1, wherein said tissue at said body portion is solid, or has no channel or opening, or is occluded, before insertion of said medical device.

4. The method according to claim 1, wherein a balloon is simultaneously pulled by the medical device, following the medical device into said body portion.

5. The method according to claim 1, wherein a guidewire is releasably attached to said medical device and simultaneously pulled by the medical device, following the medical device into said body portion.

6. The method according to claim 1, wherein a vascular graft, of native biological or artificial synthetic material, is attached to said medical device and simultaneously pulled by the medical device, following the medical device into said body portion.

7. The method according to claim 6, comprising inserting said medical device sideways into said body portion.

8. The method according to claim 7, comprising creating a bypass of a chronic total occlusion parallel to the native course of the vessel.

9. The method according to claim 6, comprising creating a bypass of a chronic total occlusion parallel to the native course of the vessel.

10. The method according to claim 1, comprising withdrawing said delivery catheter when penetration of the tissue is complete and a channel is created in the tissue, said balloon is centered in said channel, and inflating said balloon for distending said channel, which has hitherto been created by the medical device to a larger lumen, and thereby distending said medical device.

11. The method according to claim 1, comprising inflating a balloon of said delivery catheter when penetration of the tissue is complete and a channel is created in the tissue, thus distending said channel, which has hitherto been created by the medical device to a larger lumen, and thereby distending said medical device.

12. The method according to claim 1, comprising prohibiting creation of debris and loose parts, or fixating such debris and loose parts, by said device.

13. The method according to claim 1, wherein said body portion comprises an artery.

14. The method according to claim 13, wherein said body portion comprises a chronic total occlusion of a coronary artery, said method comprising holding plaque material of said chronic total occlusion compressed and together by the medical device after penetration thereof through said chronic total occlusion, after recanalization of the chronic total occlusion.

15. The method according to claim 1, comprising covering walls of a channel created with a sheet attached inside or outside to said medical device and thereby sealing off radial leakage through said medical device and prohibiting creation of debris and loose parts, or fixating such debris and loose parts.

16. The method according to claim 15, comprising inserting said medical device sideways into said body portion.

17. The method according to claim 15, comprising creating a bypass of a chronic total occlusion parallel to the native course of the vessel.

18. The method according to claim 1, comprising digging and/or cutting with extensions of said medical device through a fibrous cap of a chronic total occlusion during said penetration.

19. The method according to claim 1, comprising steerably bending a steerably bendable catheter portion of said delivery catheter for curved canalization of said body portion.

20. The method according to claim 1, wherein said body portion is liver tissue and said method comprises canalization of said liver tissue.

21. The method according to claim 20, wherein said canalization is made between the porta vein and the inferior vena cava in order to allow blood to flow from the porta system to the cava system in order to treat portal hypertension.

22. The method according to claim 21, wherein said canalization is made through obstructions to treat biliary stasis.

23. The method according to claim 20, comprising covering walls of a channel created with a sheet attached inside or outside to said medical device and thereby sealing off radial leakage through said medical device and prohibiting creation of debris and/or loose parts, or fixating such debris and/or loose parts.

24. The method according to claim 1, wherein said body portion comprises cancer tissue, and said method comprises creating connections in said tissue for palliation.

25. The method according to claim 24, wherein said body portion is in the esophagus.