Through-wall catheter steering and positioning

• US 5,906,579 A
• Filed: 08/14/1997
• Issued: 05/25/1999
• Est. Priority Date: 08/16/1996
• Status: Expired due to Term

• Current Assignee: Smith and Nephew Endoscopy Inc (Smith & Nephew PLC), University Of Massachusetts
• Original Assignee: Smith and Nephew Endoscopy Inc (Smith & Nephew PLC), University Of Massachusetts
• Inventors: Mihalca, Gheorghe, Kazakevich, Yuri E., Vander Salm, Thomas J., Conlan, A. Alan, Ek, Steven W.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US08/907,824
• Time in Patent Office: 649 Days
• Field of Search: 600/424, 128/898, 606/2, 606/7, 606/15, 606/28, 606/194, 607/88, 604/53
• US Class Current: 600/424
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0125 Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers

Abstract

A method of positioning a catheter, for example a balloon or treatment catheter. The catheter is inserted in a passage and sensed through the luminal wall to correctly determine its position. As applied to prevent hemorrhage during surgery the method involves inserting the catheter in a deflated configuration along a passage such as a blood vessel near to the operative site in a position determined by direct or video-assisted sensing from outside the passage. In the event a blood vessel is cut during surgery, the already-positioned catheter inflates a balloon to occlude the passage and stop blood flow into the injured site. In one aspect, a flow-directed catheter includes an inflatable balloon attached at its distal end and an optical fiber connected to one or more light emitting regions positioned at the tip or in the vicinity of the balloon. The light is divergent and is emitted at one or more points to provide beacons that are readily detected through the walls of a blood vessel and permit a direct determination of the exact location of the balloon within the vessel. Rather than a flow-directed balloon catheter, a drug-delivery or other catheter may be used. In that case the light emitting regions are located at or adjacent to one or more drug delivery ports or other active areas in the catheter. In another or further aspect, one or more magnetic elements are provided on the catheter, and an external magnet is used to feel and engage the catheter through the vessel wall, sense its position, steer and move it along branching vessels, and anchor the balloon in a desired position.

Claims

1. A method for controlling hemorrhage at a desired position in a vessel in an enclosed surgical arena, said method comprising the successive steps of

providing a flexible catheter body configured for travel within said vessel and including an elongated tubular wall having a proximal end and a distal end, and having at least an inflation lumen and an optical fiber extending between said ends, said fiber being configured for coupling to receive light at the proximal end and guide it to the distal end, and said fiber being configured at said distal end as a beacon which emits said received light through a wall of the vessel as a precise position marker visible externally of a wall of the vessel for allowing positioning of said catheter distal end in the vessel, said catheter body further having an inflatable balloon secured to its distal end, said balloon being inflatable via said inflation lumen and being configured for travel with said flexible catheter along a blood vessel extending to said surgical arena, said inflation lumen having a distal opening to said inflatable balloon for providing a fluid for rapid inflation and deflation of said balloon,

inserting said catheter body along the vessel,

navigating said catheter body through said vessel by directly sensing the light emitted by said beacon externally of the vessel to determine a location where an inflation of said balloon occludes blood flow to said surgical arena, and

inflating said balloon to occlude blood flow to said surgical arena, thereby controlling said hemorrhage.

2. The method of claim 1, wherein the step of inserting includes inserting the catheter into said vessel and allowing said balloon to be carried, by pressure of blood flow exerted on the balloon, toward the surgical arena.

3. The method of claim 2, wherein the step of inserting includes introducing the catheter by cutdown or percutaneous insertion into a vein and advancing the balloon to a position in a blood vessel at a site selected from a lung, liver or abdomen site.

4. The method of claim 1, wherein the surgical arena is a video-assisted surgical arena accessed in a closed body region and wherein the step of navigating includes viewing a video image of light emitted through the walls of blood vessel within the body.

5. The method of claim 4, wherein the enclosed surgical arena is a body cavity selected from among the pleural, peritoneal and pericardial cavity, and operating spaces formed in the preplural, preperitoneal and prepericardial areas of a body.

6. The method of claim 1, wherein the balloon is shaped to occlude a pulmonary artery.

7. The method of claim 1, including the step of providing an inflation medium to the balloon to occlude flow through the vessel at said position.

8. The method of claim 1, wherein said beacon emits light substantially omnidirectionally from a localized site on the catheter.

9. The method of claim 8, wherein the catheter is a drug delivery catheter and said localized site is associated with a drug delivery port so that viewing the light emission determines a location for drug delivery.

10. The method of claim 1, further comprising the steps of:

creating incisions in a body and inserting surgical instruments and endoscopic camera through said incisions to perform surgery at an operative site,

inserting the balloon catheter, wherein the catheter is provided with said beacon located at a defined position, through a vessel to a neighborhood of the operative site, and

establishing visual contact with the beacon through a vessel wall to thereby determine a position of the balloon catheter effective to block circulation to the surgical arena.

11. A method for controlling hemorrhage at a position in a vessel in an enclosed surgical arena said method comprising the successive steps of

providing a flexible catheter having an inflatable balloon,

securing to said balloon magnetic material for magnetic engagement and positioning of the balloon by manipulation of a magnet located outside the vessel,

inserting said catheter along the vessel to a location where an inflation of said balloon occludes blood flow to said surgical arena, and

inflating said balloon to occlude blood flow to said surgical arena to control the hemorrhage.

12. The method of claim 11, wherein the step of inserting said catheter body includes at least one of

moving said catheter by magnetically engaging the magnetic material, and

anchoring said catheter by magnetically engaging the magnetic material.

13. The method of claim 11, further comprising the successive steps of

creating incisions in a body and inserting surgical instruments and an endoscopic camera through said incisions to perform surgery at an operative site,

inserting the balloon catheter, wherein the catheter is provided with said magnetic material located at a defined position, through a vessel to a neighborhood of the operative site, and

establishing magnetic contact with the marker through a vessel wall to thereby determine a position of the balloon catheter effective to block circulation to the surgical arena.

14. The method of claim 13, wherein said surgical arena is selected from the group including thoracoscopic, laparoscopic, endoluminal, perivisceral and intra-articular surgical arenas.

15. The method of claim 11, wherein the step of inserting includes inserting the catheter into a vessel and allowing said balloon to be carried by pressure of blood flow exerted on the balloon, toward the surgical arena.

16. The method of claim 15, wherein the step of inserting includes introducing the catheter by cutdown or percutaneous insertion into a vein and advancing the balloon to a position in a blood vessel at a site selected from a lung, liver or abdomen site.

17. The method of claim 11, wherein the balloon is shaped to occlude a pulmonary artery.

18. The method of claim 11, including the step of providing an inflation medium to the balloon to occlude flow through the vessel at said position.

19. A method for controlling hemorrhage in an enclosed surgical arena, such method comprising the steps of

inserting into a vessel extending to said surgical arena a balloon catheter,

providing a directly sensible marker, selected from the group consisting of a magnetically engageable marker and a light emitting marker, on said catheter,

directly sensing the marker carried by the catheter from outside the vessel, and

positioning the balloon to a location where an inflation of said balloon occludes blood flow to a surgical arena, and inflating said balloon to occlude blood flow to the surgical arena.

20. The method of claim 19, wherein said marker is a magnetically engageable marker, and further comprising the step of magnetically feeling the catheter through the vessel wall by engaging said marker.

21. The method of claim 19, wherein said balloon has magnetic material thereon and said marker is a light emitter which is directly viewed through a vessel wall, and further comprising the steps of magnetically manipulating the catheter through the vessel wall by engaging said magnetic material while viewing the marker, and magnetically anchoring the catheter in a desired position.

22. The method of claim 21, wherein the step of magnetically anchoring includes anchoring in a pulmonary artery to occlude circulation to a pulmonary lobe.

23. The method of claim 22, further comprising the step of defunctioning the lobe to shrink the lobe for surgery.