Intravascular catheter and method of controlling hemorrhage during minimally invasive surgery

• US 5,904,147 A
• Filed: 08/16/1996
• Issued: 05/18/1999
• 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: Ek, Steven W., Mihalca, Gheorghe, Kazakevich, Yuri E., Conlan, A. Alan
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/696,572
• Time in Patent Office: 1,005 Days
• Field of Search: 604/99-101, 604/20-21, 606/2, 606/15, 606/191-194, 606/111, 600/113-117, 600/129, 600/160, 600/178-179, 600/12, 600/182, 600/146, 600/424, 600/585, 607/88, 607/90, 128/899
• US Class Current: 128/899
• 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 catheter, for example a balloon or treatment catheter, is positioned to prevent hemorrhage during surgery by 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 viewing from outside the passage. In the event a blood vessel is cut during surgery, the previously positioned catheter inflates a balloon to occlude the passage and stop blood flow into the injured site. 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 in the vicinity of the balloon. The light is emitted transversely, and preferably omnidirectionally at one or more points with a sufficient brightness 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.

Claims

1. A catheter apparatus for controlling hemorrhage in an enclosed surgical arena, said apparatus comprising

a flexible catheter body configured for travel within a blood vessel extending to the surgical arena by percutaneous insertion or cutdown to access a site in the vessel, said catheter body including an elongated tubular wall having proximal and distal ends, 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 light to the distal end, and said fiber being configured at said distal end as a beacon which emits said received light through the wall of the vessel as a precise position marker visible externally of the vessel wall for allowing positioning of said catheter distal end in the vessel, and

a balloon secured at said distal end of the flexible catheter body and inflatable via said inflation lumen, said balloon being configured for travel with said flexible catheter along the blood vessel, said inflation lumen having a distal opening into said inflatable balloon for providing a fluid flow for rapid inflation and deflation of the balloon, whereby, when precise position of the balloon within a blood vessel is visually confirmed by viewing said beacon, the balloon is disposed for inflation to occlude blood flow and prevent hemorrhage in an identified region of the surgical arena, and

magnetic material secured to said balloon for magnetic engagement and positioning of the balloon by manipulation of a magnet located outside the blood vessel.

2. The catheter apparatus of claim 1, further comprising a monitor lumen having proximal and distal ends which extends completely through the catheter body distally past said balloon to communicate with blood in the vessel for measuring pulmonary arterial pressure when the catheter is in place and the balloon is deflated, and for measuring pulmonary capillary wedge pressure when the balloon is inflated.

3. The catheter apparatus of claim 2, wherein the proximal end of said monitor lumen is configured for at least one of blood sampling and infusion of a therapeutic drug.

4. The catheter apparatus of claim 1, wherein the fiber emits light in a band which is directly visible or within the spectral band of a video camera.

5. The catheter apparatus of claim 1, wherein the fiber is configured to emit light at one or more regions selected from the distal end, the proximal end, the entire length of said balloon, and combinations thereof.

6. The catheter apparatus of claim 1, wherein the balloon includes a portion having a generally cylindrical inflated shape with a largest diameter in a plane transverse to the long axis of said cylinder and located intermediate the ends of said cylinder, and a balloon diameter which decreases in both directions along said axis.

7. The catheter apparatus of claim 1, wherein the balloon includes at least a first portion which inflates to a size to occlude the blood vessel and a second portion which inflates to a size effective to contact the vessel and anchor the balloon with a shape that leaves a passage in the vessel open, so that the balloon is thereby configured, upon inflating the second portion and not the first portion, to anchor within the vessel without fully obstructing circulation therein.

8. The apparatus of claim 1, wherein said balloon has a size to occlude circulation in a blood vessel selected from among the thoracic, liver and abdominal vasculature.

9. The catheter apparatus of claim 1, wherein the catheter is a flow-directed catheter in which the balloon is entrained by flow to carry the catheter to an operative position.