Catheter apparatus and method for arterializing a vein

• US 6,464,665 B1
• Filed: 07/05/2000
• Issued: 10/15/2002
• Est. Priority Date: 07/05/2000
• Status: Expired due to Term

• Current Assignee: PQ Bypass, Inc.
• Original Assignee: Richard R. Heuser
• Inventors: Heuser, Richard R.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/609,992
• Time in Patent Office: 832 Days
• Field of Search: 604/96.01, 604/101.01, 604/101.03, 604/101.05, 604/104-109, 606/159, 606/167, 606/189, 606/194, 623/1.11, 623/1.12, 623/1.15, 623/1.2, 623/1.36
• US Class Current: 604/104
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes

Abstract

A catheter apparatus is provided including an arterial catheter and a venous catheter wherein the distal ends of the catheter are insertable in an artery and a adjacent vein, respectively to a position adjacent a site for creating a fistula. The venous catheter includes a radially expandable structure adjacent the distal end which can be selectively extended outwardly to expand a portion of the wall of the vein adjacent the venous fistula site towards contact with the wall of the artery adjacent the arterial fistula site. The radially expandable structure of the venous catheter may include one or more balloons which can be inflated or a wire basket, or the vein can be expanded by injecting a fluid through an injection port into an isolated portion of the vein. The apparatus further includes a tool for creating an opening through the wall of the artery adjacent the arterial fistula site and an opening through the outwardly extending portion of the wall of the vein adjacent the venous fistula site to extend outwardly the portion of the wall of the vein towards contact with the wall of the artery. The tool may include a needle coupled to the arterial catheter adjacent the distal end of the arterial catheter, the needle being selectively switchable between a first, inactive configuration wherein the needle can be guided through the artery without causing trauma to the artery wall and a second, active configuration wherein the needle is operative to create the opening in the artery wall. The fistula between the openings may be completed with the aid of a stent, and the proximal portion of the vein blocked with an embolization device.

Claims

1. A catheter apparatus for arterializing a vein by creating a fistula between the vein and an artery, the apparatus comprising:

an arterial catheter having a distal end insertable to a position wherein the distal end is adjacent a site within the artery for the fistula,

a venous catheter having a distal end insertable to a position wherein the distal end is adjacent a site within the vein for the fistula, the venous catheter including a radially expandable structure adjacent the distal end which selectively extends outwardly a portion of the wall of the vein adjacent the venous fistula site towards contact with the wall of the artery adjacent the arterial fistula site, a tool for creating an opening through the wall of the artery adjacent the arterial fistula site and an opening through the outwardly extending portion of the

wall of the vein adjacent the venous fistula site,

wherein the radially expandable structure of the venous catheter includes a wire basket deployable adjacent the distal end of the venous catheter, the wire basket being expandable with sufficient force to extend outwardly the wall of the vein towards contact with the arterial wall.

2. The catheter apparatus of claim 1 wherein the wire basket includes a radiopaque marker.

3. A catheter apparatus for arterializing a vein by creating a fistula between the vein and an artery, the apparatus comprising:

an arterial catheter having a distal end insertable to a position wherein the distal end is adjacent a site within the artery for the fistula,

a venous catheter having a distal end insertable to a position wherein the distal end is adjacent a site within the vein for the fistula, the venous catheter including a radially expandable structure adjacent the distal end which selectively extends outwardly a portion of the wall of the vein adjacent the venous fistula site towards contact with the wall of the artery adjacent the arterial fistula site, and

a tool for creating an opening through the wall of the artery adjacent the arterial fistula site and an opening through the outwardly extending portion of the wall of the vein adjacent the venous fistula site, wherein the tool includes a needle coupled to the arterial catheter adjacent the distal end of the arterial catheter, the needle being selectively switchable between a first, inactive configuration wherein the needle can be guided through the artery without causing trauma to the artery wall and a second, active configuration wherein the needle is operative to create the opening in the artery wall, and wherein the needle is hollow and terminates in a beveled, pointed tip, and wherein the tool further includes a wire selectively insertable through the needle, the wire having a generally blunt distal end, the wire and needle providing the inactive configuration when the distal end of the wire extends through the needle to a position at least flush with the needle tip, and the wire and needle providing the active configuration when the wire is retracted from the needle tip.

4. A catheter apparatus for arterializing a vein by creating an opening in the vein wall and an opening in an arterial wall, and developing a fistula between the vein and the artery, the apparatus comprising:

an arterial catheter having a distal end insertable to a position adjacent a site within the artery for the fistula,

a venous catheter having a distal end insertable to a position adjacent a site within the vein for the fistula, the venous catheter including a wire basket adjacent the distal end of the venous catheter, the wire basket selectively deployable to extend the wall of the vein outwardly towards contact with the wall of the artery, and

a tool for creating an opening through the wall of the artery and an opening through the wall of the vein adjacent the sites for the fistula.

5. The catheter apparatus of claim 4 further comprising a first magnet disposed on the wire basket and a second magnet disposed on the distal end of the arterial catheter, the magnets configured for mutual attraction to urge the wire basket and the distal end of the arterial catheter toward one another.

6. The catheter apparatus of claim 4 wherein the arterial catheter includes a body defining a longitudinal axis, the arterial catheter further including a distal tip that is selectively switchable between a first configuration wherein the tip is offset from the longitudinal axis by at least about 30°

, and a second configuration wherein the distal tip aligns generally with the longitudinal axis.

7. The catheter apparatus of claim 6 further comprising a stiffening wire insertable through the arterial catheter, wherein the distal tip of the arterial catheter is nominally in the first configuration and is selectively switchable to the second configuration by insertion of the stiffening wire through the arterial catheter to a position adjacent the distal tip.

8. The catheter apparatus of claim 4 wherein the tool includes a wire having a sharp tip, the wire insertable through the arterial catheter for deployment of the sharp tip adjacent the distal end of the arterial catheter, and wherein at least one of the wire basket and the sharp wire includes a magnet, and the other one of the wire basket and the sharp wire includes magnetically-attracted material.

9. The catheter apparatus of claim 8 wherein the wire includes a magnet disposed adjacent the tip, and wherein the wire basket includes a magnet, the magnets arranged for mutual attraction between the wire and the basket.

10. The catheter apparatus of claim 4 wherein the venous catheter includes a first lumen defined therethrough for receiving the wire basket, a second lumen defined therethrough for injection of a contrast adjacent the distal end of the venous catheter, and a third lumen for receiving a guidewire.

11. The catheter apparatus of claim 4 wherein the wire basket includes a radiopaque marker.

12. The catheter apparatus of claim 4, wherein the tool includes a needle for creating the openings through the walls of the artery and the vein, the needle providing a selectable inactive configuration, and a selectable active configuration for creating the openings.

13. The catheter apparatus of claim 12, wherein the needle is installed adjacent the distal end of the arterial catheter, and the needle is within the distal end in the inactive configuration, and the needle extends beyond the distal end in the active configuration.

14. The catheter apparatus of claim 12, wherein the needle is installed extending beyond the distal end of the arterial catheter, the needle pointing generally straight out from the catheter in the inactive configuration, and the needle disposed at an angle of at least about 30°

with respect to a longitudinal axis of the arterial catheter.

15. The catheter apparatus of claim 4 wherein the arterial catheter defines a lumen and the tool includes a sharp wire configured for insertion through the lumen, the wire further configured to be deployed beyond the distal end of the arterial catheter to create the openings in the walls of the artery and the vein.

16. The catheter apparatus of claim 4 further including an embolization catheter for depositing an embolization device at a location in the vein proximal to the fistula.

17. The catheter apparatus of claim 4 further including a stent for connecting the artery and the vein at the fistula.

18. The catheter apparatus of claim 17 wherein the stent includes a frame defining a cross-sectional area, the stent expandable to increase the cross-sectional area by a factor of at least about 10.

19. The catheter apparatus of claim 17 wherein the stent includes a plurality of hooks configured to embed in at least one of the artery and the vein walls.

20. The catheter apparatus of claim 17 wherein the stent includes a plurality of hooks configured to embed in the artery wall and in the vein wall.

21. The catheter apparatus of claim 4 wherein at least one of the arterial catheter and the venous catheter includes at least three lumens.

22. The catheter apparatus of claim 4 wherein the arterial catheter includes a body defining a longitudinal axis and a distal tip that is selectively switchable between a first configuration generally parallel to the longitudinal axis and a second configuration offset from the longitudinal axis by at least about 60°

.

23. A method of arterializing a peripheral vein by creating a fistul a between the vein and a peripheral artery, the method comprising:

providing an arterial catheter having a distal end and inserting the arterial catheter into the artery to a position wherein the distal end is adjacent a site for the fistula within the artery;

providing a venous catheter having a distal end and inserting the venous catheter into the vein to a position wherein the distal end is adjacent a site for the fistula within the artery;

after positioning the arterial and venous catheters, radially expanding a portion of the vein wall adjacent the venous fistula site to bring the venous fistula site in closer proximity to the arterial fistula site;

after radially expanding the portion of the vein wall, creating an opening through the wall of the artery adjacent the arterial fistula site and creating an opening through the wall of the vein adjacent the venous fistula site,

wherein the venous catheter includes a wire basket deployable adjacent the distal end of the venous catheter,

and wherein the step of radially expanding a portion of the vein wall includes deploying the wire basket.

24. The method of claim 23 wherein the wire basket includes a radiopaque marker and further comprising the step, before creating the openings in the vein and artery walls, of radiographically observing the position of the marker.

25. The method of claim 23, further comprising the steps of providing a stent and depositing the stent through the openings in the walls of the artery and the vein to form a passageway between the artery and the vein.

26. The method of claim 25, wherein the stent includes a plurality of hooks configured to embed in at least one of the artery wall and the vein wall.

27. The method of claim 23, wherein the vein includes a valve distal of the fistula, and further including the steps of providing a cutting device, and inserting the cutting device into the vein and excising at least a portion of the valve.