Intravascular imaging guidewire

• US 6,078,831 A
• Filed: 09/29/1997
• Issued: 06/20/2000
• Est. Priority Date: 09/29/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Pantages, Anthony J., Belef, William Martin, Wasicek, Lawrence D.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US08/939,315
• Time in Patent Office: 995 Days
• Field of Search: 600/424, 600/433, 600/434, 600/435, 600/437, 600/459, 600/462, 600/463, 600/466, 600/467, 604/264, 604/280, 604/282
• US Class Current: 600/424
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An intravascular imaging guidewire which can accomplish longitudinal translation of an imaging plane allowing imaging of an axial length of a region of interest without moving the guidewire. The imaging guidewire comprises a body in the form of a flexible elongate tubular member. An elongate flexible imaging core is slidably received within the body. The imaging core includes a shaft having an imaging device mounted on its distal end. The body and the imaging core are cooperatively constructed to enable axial translation of the imaging core and imaging device relative to the body. The body has a transparent distal portion extending an axial length over which axially translatable imaging may be performed. The imaging guidewire has a maximum diameter over its entire length sized to be received within a guidewire lumen of an intravascular catheter.

Claims

1. An imaging guidewire for use with a separate catheter, the catheter including a guidewire lumen for receiving the imaging guidewire, the catheter being axially moveable along the entire length of the imaging guidewire, said imaging guidewire comprising:

a guidewire body in the form of an elongate flexible tubular member, said guidewire body having a proximal end and a distal end, at least a portion of said guidewire body being substantially transparent to imaging energy, and at least a portion of said guidewire body being formed from a material having sufficient flexibility to traverse a tortuous path through a vascular system and having sufficient torsional and lateral stiffness to transmit a pushing force from the proximal end to the distal end when said guidewire body is disposed within said vascular system;

a flexible elongate imaging core slideably received within said guidewire body, said imaging core having a shaft and an imaging device mounted on a distal end of said shaft and arranged to position said imaging device in axial relation to said substantially transparent portion of said guidewire body, said imaging device adapted to receive imaging energy related to an internal anatomical structure and to transmit imaging signals to an imaging signal processor;

the imaging guidewire having a maximum diameter along its entire length not exceeding substantially 0.035 inch;

wherein said imaging core is axially translatable relative to said guidewire body to enable axial translation of said imaging device.

2. The imaging guidewire of claim 1 further comprising a connector attached to a proximal end of said shaft, said connector being detachably connectable with a mating connector to operatively connect the imaging device to the imaging signal processor.

3. The imaging guidewire of claim 2 wherein said imaging core is rotatable within said body, said shaft is a drive shaft for rotating said imaging device and said connector is detachably connectable with a mating connector to engage a drive unit to rotate said drive shaft.

4. The imaging guidewire of claim 3 wherein said imaging device comprises an ultrasound transducer arranged to transmit and receive ultrasonic signals to and from the internal anatomical structure.

5. The imaging guidewire of claim 1 wherein said body comprises a proximal body portion having a proximal end extending from the proximal end of said body and a distal end attached to said substantially transparent portion of said body.

6. The imaging guidewire of claim 5 further comprising a stiffening tube disposed between said body and said shaft, said stiffening tube extending from said proximal end of the guidewire to the proximal end of said transparent portion of said body.

7. The imaging guidewire of claim 5 wherein said proximal body portion is formed of a nitinol™

tube.

8. The imaging guidewire of claim 7 wherein said shaft comprises a proximal telescope portion having a distal end connected to a drive cable formed of counterwound, multifilar coils.

9. The imaging guidewire of claim 5 further comprising a transition means between said proximal body portion and said substantially transparent portion of said body.

10. The imaging guidewire of claim 9 wherein said transition means is formed by constructing a distal portion of said proximal body portion in a spiral form, said spiral form having increasing pitch as it extends distally.

12. The imaging guidewire of claim 5 wherein said shaft comprises a proximal telescope portion having a distal end connected to a drive cable formed of counterwound, multifilar coils.

13. The imaging guidewire of claim 5 wherein said transition means comprises a transition tube having a bending stiffness between that of the proximal body portion and the substantially transparent portion of said body.

15. The imaging guidewire of claim 1 wherein said shaft comprises a proximal telescope portion having a distal end connected to a drive cable formed of counterwound, multifilar coils.

16. The imaging guidewire of claim 1 further comprising a connector attached to a proximal end of said shaft, said connector being detachably connectable with a mating connector to operatively connect the imaging device to the imaging signal processor while simultaneously engaging a drive unit to rotate said shaft and wherein said imaging core is rotatable within said body, said shaft is a drive shaft for rotating said imaging device and said connector is detachably connectable with a mating connector to engage a drive unit to rotate said drive shaft.

17. The imaging guidewire of claim 16 wherein said connector comprises:

a distal component including a conductive ring through which a coaxial cable having an inner lead and an outer lead separated by a first insulator is inserted and said conductive ring filled with a first portion of conductive epoxy to electrically connect the outer lead to the conductive ring; and

a proximal component including a second conductor having stepped tubular section and a ball-shaped end having a cavity, an insulator covering said stepped tubular section, the inner lead and insulation extending through said tubular section and into said cavity, and said cavity filled with a second portion of conductive epoxy to electrically connect said inner lead to said second conductor, said proximal component inserted into said conductive ring by inserting said stepped tubular section covered with said insulator into said conductive ring.

11. The imaging guidewire of 9 wherein said transition means is formed by constructing a distal portion of said proximal body portion in tapered finger shape.

14. The imaging guidewire of claim further comprising a plastic jacket covering substantially the entire length of said body.

18. A method for diagnosis and treatment of an internal body structure comprising the steps of:

providing an imaging guidewire including;

a guidewire body in the form of an elongate flexible tubular member, said guidewire body having a proximal end and a distal end, at least a portion of said guidewire body being substantially transparent to imaging energy, at least a portion of said guidewire body is formed from a material having sufficient flexibility to traverse a tortuous path through a vascular system, the material also exhibiting sufficient pushability to transmit a pushing force from the proximal end to the distal end when said guidewire body is disposed within said vascular system;

a flexible elongate imaging core slideably received within said guidewire body, said imaging core having a shaft and an imaging device mounted on a distal end of said shaft and arranged to position said imaging device in axial relation to said substantially transparent portion of said guidewire body, said imaging device adapted to receive imaging energy related to an internal anatomical structure and to transmit imaging signals to an imaging signal processor;

the imaging guidewire having a maximum diameter along its entire length not exceeding substantially 0.035 inch;

wherein said imaging core is axially translatable relative to said guidewire body to enable axial translation of said imaging device;

introducing said imaging guidewire into a vessel of a vascular system and routing said imaging guidewire to the internal body structure;

producing images of said internal body structure using said imaging device; and

axially translating said imaging core relative to said guidewire body to image a length of the internal body structure.

19. The method of claim 18 further comprising the step of routing a catheter having a guidewire lumen over the imaging guidewire and advancing the catheter to the internal anatomical structure.

20. An imaging guidewire for use with a separate catheter, the catheter including a guidewire lumen for receiving the imaging guidewire, the catheter being axially moveable along the entire length of the imaging guidewire, said imaging guidewire comprising:

an imaging guidewire,

said imaging guidewire having a central axis and a central cavity formed along a substantial portion of said central axis, said central cavity being configured to receive and allow axial and rotational movement of an imaging core,

said imaging guidewire further including at least a portion thereof formed from a material having sufficient flexibility to traverse a tortuous path through a vascular system, the material also exhibiting sufficient pushability to transmit a pushing force from a proximal end of the imaging guidewire to a distal end of the imaging guidewire; and

said guidewire having adjacent a portion of said central cavity a wall section that is substantially transparent to imaging energy.

21. The article of claim 20, wherein said guidewire has a diameter along its entire length of not more than substantially 0.035 inch.

22. The article of claim 20, wherein the imaging guidewire is formed from nitinol™

.

23. The article of claim 20, wherein the imaging guidewire comprises a polymer sheath.

24. The article of claim 23, wherein the polymer sheath comprises a material selected from the group consisting of polyimide and PEEK.

25. The article of claim 20, wherein said guidewire has a floppy tip provided on a distal end thereof.

26. The article of claim 20, wherein a stiffening member is provided within a predetermined section of said central cavity of said guidewire to enhance a stiffness characteristic of said guidewire.

27. An imaging guidewire comprising:

a body in the form of an elongate flexible tubular member, said body having a proximal end and a distal end, at least a portion of said body being substantially transparent to imaging energy;

a flexible elongate imaging core slideably received within said body, said imaging core having a shaft and an imaging device mounted on a distal end of said shaft and arranged to position said imaging device in axial relation to said substantially transparent portion of said body, said imaging device adapted to receive imaging energy related to an internal anatomical structure and to transmit imaging signals to an imaging signal processor;

the imaging guidewire having a maximum diameter along its entire length not exceeding that which can effectively be received in a guidewire lumen of an intravascular catheter;

wherein said imaging core is axially translatable relative to said body to enable axial translation of said imaging device;

wherein said body comprises a proximal body portion having a proximal end extending from the proximal end of said body and a distal end attached to said substantially transparent portion of said body;

transition means between said proximal body portion and said substantially transparent portion of said body; and

wherein said transition means is formed by constructing a distal portion of said proximal body portion in a spiral form, said spiral form having increasing pitch as it extends distally.

28. An imaging guidewire comprising:

a body in the form of an elongate flexible tubular member, said body having a proximal end and a distal end, at least a portion of said body being substantially transparent to imaging energy;

a flexible elongate imaging core slideably received within said body, said imaging core having a shaft and an imaging device mounted on a distal end of said shaft and arranged to position said imaging device in axial relation to said substantially transparent portion of said body, said imaging device adapted to receive imaging energy related to an internal anatomical structure and to transmit imaging signals to an imaging signal processor;

the imaging guidewire having a maximum diameter along its entire length not exceeding that which can effectively be received in a guidewire lumen of an intravascular catheter;

wherein said imaging core is axially translatable relative to said body to enable axial translation of said imaging device;

a connector attached to a proximal end of the shaft, said connector being detachably connectable with a mating connector to operatively connect the imaging device to the imaging signal processor while simultaneously engaging a drive unit to rotate said shaft and wherein said imaging core is rotatable within said body, said shaft is a drive shaft for rotating said imaging device and said connector is detachably connectable with a mating connector to engage a drive unit to rotate said drive shaft; and

wherein said connector comprises;

a distal component including a conductive ring through which a coaxial cable having an inner lead and an outer lead separated by a first insulator is inserted and said conductive ring filled with a first portion of conductive epoxy to electrically connect the outer lead to the conductive ring; and

a proximal component including a second conductor having a stepped tubular section and a ball-shaped end having a cavity, an insulator covering said stepped tubular section, the inner lead and insulation extending through said tubular section and into said cavity, and said cavity filled with a second portion of conductive epoxy to electrically connect said inner lead to said second conductor, said proximal component inserted into said conductive ring by inserting said stepped tubular section covered with said insulator into said conductive ring.