High pressure perfusion device

• US 5,797,876 A
• Filed: 11/27/1995
• Issued: 08/25/1998
• Est. Priority Date: 11/27/1995
• Status: Expired due to Term

• Current Assignee: TherOx Incorporated (Asahi Kasei Corporation), Wayne State University
• Original Assignee: TherOx Incorporated (Asahi Kasei Corporation), Wayne State University
• Inventors: Zalesky, Paul J., Spears, J. Richard, Levin, Philip S.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/563,057
• Time in Patent Office: 1,002 Days
• Field of Search: 604/49, 604/52, 604/53, 604/264, 604/27, 604/200, 604/95, 604/202, 604/19
• US Class Current: 604/95.02
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

The present invention includes a guidewire device capable of delivering perfusion fluids to a vascular site while at the same time exhibiting handling characteristics associated with existing non-perfusion guidewires. Preferred embodiments include a perfusion guidewire which closely matches the dimensions and physical characteristics of standard guidewires. Preferred embodiments also permit high pressure perfusion of supersaturated solutions, and include a liquid flow path which will not promote bubble generation or growth, or destabilize a supersaturated solution.

Claims

1. A perfusion guidewire for the delivery of liquid, comprising:

a tubular housing defining a fluid lumen therethrough, the housing having a proximal end and a distal end, wherein the distal end of the housing is formed in the shape of an elongated tapered lip;

a core wire having a proximal end and a distal end, the proximal end of the core wire being secured to the tapered lip of the tubular housing;

a first coil mounted at the distal end of the core wire; and

an elongated cylindrical sheath extending from an area proximal to the tapered lip and over a portion of the core wire, the sheath defining a continuation of the fluid lumen and having at least one fluid exit.

2. A guidewire as in claim 1, wherein the tubular housing is an elongated, flexible member having a cylindrical side wall, a portion of the side wall being removed such that a remaining portion of the side wall forms said elongated tapered lip.

3. A guidewire as in claim 2, wherein the elongated tapered lip forms an open helix which reduces cast in the guide wire.

4. A guidewire as in claim 1, further comprising a coil surrounding at least a portion of the cylindrical sheath.

5. A guidewire as in claim 4, wherein the first coil and the coil surrounding at least a portion of the cylindrical sheath comprise a single coil extending from the tubular housing to the guidewire distal end.

6. A guidewire as in claim 1 wherein the elongated tapered lip is helical.

7. A guidewire as in claim 1 wherein the elongated cylindrical sheath is made of polymer tubing.

8. A guidewire as in claim 7 wherein the distal end of the polymer tubing is open.

9. A guidewire as in claim 7 wherein the distal end of the polymer tubing is sealed.

10. A guidewire as in claim 9 wherein the polymer tubing has a plurality of perforations.

11. A guidewire as in claim 10 further including a second, elongated coil mounted over the polymer tubing.

12. A guidewire as in claim 11 further including a porous membrane mounted between the polymer tubing and the second coil.

13. A guidewire as in claim 10 further including a second, elongated coil mounted underneath the polymer tubing.

14. A guidewire as in claim 1, wherein the elongated tapered lip comprises an elongated member secured to the distal end of the tubular housing.

15. A perfusion guidewire suitable for the delivery of oxygen supersaturated liquid, comprising:

a high pressure tubular housing defining a lumen therein, the high pressure tubular housing having a proximal end and a distal end;

a tubular segment mounted within the distal end of the high pressure tubular housing, the tubular segment having a proximal end and a distal end;

the distal end of the tubular segment formed in the shape of an elongated tapered lip;

a core wire having a proximal end and a distal end;

the proximal end of the core wire being tapered and bonded to the tapered lip;

a first coil mounted on the distal end of the core wire;

an elongated cylindrical sheath extending from at least an area proximal to the tapered lip, and extending over a substantial portion of the core wire;

the elongated cylindrical sheath having at least one fluid exit; and

a second, elongated coil mounted over the elongated cylindrical sheath.

16. A perfusion guidewire as in claim 15 wherein the elongated cylindrical sheath includes a non-porous section immediately distal to the tubular housing, and a porous section distal to the non-porous section.

17. A perfusion guidewire as in claim 16 wherein the porous section of the elongated cylindrical sheath includes perforated tubing.

18. A perfusion guidewire as in claim 17 wherein the porous section of the elongated cylindrical sheath includes perforated tubing surrounded by a permeable membrane.

19. A perfusion guidewire as in claim 16 wherein the porous section of the elongated cylindrical tubing includes a permeable membrane.

20. A high pressure perfusion guidewire as in claim 15 wherein the proximal end of the tubular segment is also formed in the shape of an elongated tapered lip.

21. A high pressure perfusion guidewire as in claim 15 wherein the distal end of the elongated cylindrical sheath is open.

22. A high pressure perfusion guidewire as in claim 15 wherein the distal end of the elongated cylindrical sheath is closed.

23. A perfusion guidewire suitable for replacement of standard guidewires and for the delivery of fluid to a treatment site, comprising:

a tubular housing defining a fluid lumen therethrough, the housing having a proximal end and a distal end;

a core wire disposed at the distal end of the tubular housing and having a proximal end and a distal end;

wherein the distal end of the tubular housing and the proximal end of the core wire comprise a transition zone that provides a smooth transition in flexibility and uniform transmission of torque as between the tubular housing and core wire such that the guidewire exhibits handling characteristics substantially the same as standard guidewires;

a first coil mounted at the distal end of the core wire; and

an elongated cylindrical sheath extending from the tubular housing and over a portion of the core wire, the sheath defining a continuation of the fluid lumen and having at least one fluid exit.

24. The guidewire according to claim 23, wherein the transition zone includes means for joining the tubular housing and core wire, the tubular housing being provided with a gradually increasing flexibility in the direction of the distal end.

25. The guidewire according to claim 24, wherein a tapered lip is formed at the distal end of the tubular housing, and the proximal end of the core wire is secured to said tapered lip.

26. The guidewire according to claim 25, wherein the tubular housing is an elongated, flexible member having a cylindrical side wall, a portion of the tubular housing side wall being removed such that a remaining portion of the side wall forms said tapered lip.

27. A perfusion guidewire, comprising:

a flexible, torque transmitting, high pressure tubing defining a fluid lumen therethrough, the tubing having a proximal end and a distal end;

a core wire having a proximal end and a distal end, the proximal end of the core wire being disposed at the distal end of the tubing;

a first coil mounted at the distal end of the core wire;

an elongated cylindrical sheath extending from the tubular housing over a portion of the core wire, the sheath defining a continuation of the fluid lumen; and

a baffle zone extending along at least a portion of the core wire, the baffle zone defining at least one fluid exit and including perforated tubing surrounded by a permeable membrane, the permeable membrane surrounded by a second, elongated coil, wherein the baffle zone creates a flow velocity drop such that fluid perfused through said guidewire leaves said fluid exit under atraumatic conditions.

28. The guidewire according to claim 27, wherein the high pressure tubing has a burst strength exceeding about 1000 psi.

29. The guidewire according to claim 27, wherein the baffle zone provides a flow velocity drop of at least one order of magnitude.

30. The guidewire according to claim 27, wherein the baffle zone provides an atraumatic fluid exit velocity of less than about 200 cm/sec.

31. A perfusion guidewire, comprising:

a flexible, torque transmitting, high pressure tubing defining a fluid lumen therethrough, the tubing having a proximal end and a distal end;

a core wire having a proximal end and a distal end;

a transition zone that joins the distal end of the high pressure tubing to the proximal end of the core wire to provide a smooth transition in flexibility and uniform transmission of torque as between said tubing and core wire, the transition zone including means for joining the high pressure tubing and core wire such that the tubing is provided with a gradually increasing flexibility in the direction of the distal end;

a first coil mounted at the distal end of the core wire;

an elongated cylindrical sheath extending from the tubular housing over a portion of the core wire, the sheath defining a continuation of the fluid lumen; and

a baffle zone extending along at least a portion of the core wire, the baffle zone defining at least one fluid exit and comprising means for creating a flow velocity drop such that fluid perfused through said guidewire leaves said fluid exit under atraumatic conditions.

32. The guidewire according to claim 31, wherein the distal end of the tubing is formed in the shape of an elongated tapered lip.