Method of delivery therapeutic or diagnostic liquid into tissue surrounding a body lumen

• US 5,611,775 A
• Filed: 05/06/1994
• Issued: 03/18/1997
• Est. Priority Date: 03/15/1993
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Michaels, Mary B., Machold, Timothy R., Robinson, Janine C., Sirhan, Motasim M.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/238,904
• Time in Patent Office: 1,047 Days
• Field of Search: 604/96, 604/101, 604/265, 604/52, 604/53, 606/192, 606/194
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter and method of using the catheter for the delivery of therapeutic or diagnostic liquid within a body lumen of a patient. The catheter has an outer inflatable member which has a wall with a plurality of apertures which eject therapeutic or diagnostic liquid in a jet-like form deep within the lumenal tissue adjacent to the outer inflatable member. In one embodiment the catheter has an inner inflatable member disposed within the outer inflatable member which upon inflation expands the outer tubular member so as to dilatate a stenotic region of a body lumen such as an artery. The inflatable member may be provided with proximal and distal ends which expand to larger diameters than the central inflatable section so as to seal the larger ends and prevent the loss of fluid.

Claims

1. A method of delivering therapeutic or diagnostic material in liquid form into tissue surrounding a body lumen of a patient comprising:

a) providing a catheter with;

a catheter shaft having proximal and distal ends and at least one inner lumen extending therein;

an inflatable member on a distal portion of the catheter shaft having an interior in fluid communication with the inner lumen extending within the catheter shaft and a wall with a plurality of small apertures extending therethrough; and

means to direct therapeutic or diagnostic material in liquid form from the inner lumen to the interior of the inflatable member;

b) advancing the catheter through a body lumen of a patient until the inflatable member is disposed at a site therein where the therapeutic or diagnostic liquid is to be delivered; and

c) directing therapeutic or diagnostic liquid through the inner lumen into the interior of the inflatable member so that the liquid is ejected from the plurality of small apertures in the wall of the inflatable member in the form of a corresponding plurality of individual streams, each individual stream having a velocity capable of piercing the tissue surrounding the body lumen so that the liquid enters the tissue as a stream, to form a resevoir of therapeutic or diagnostic material within the tissue surrounding the body lumen.

2. The method of claim 1 wherein the liquid velocity through the apertures is about 0.5 to about 15 meters/sec.

3. The method of claim 1 wherein the liquid velocity through the apertures is about 3 to about 8 meters/sec.

4. The method of claim 1 wherein the volumetric flow rate per aperture ranges from about 0.0015 to about 0.05 ml/sec.

5. A method of dilating a blood vessel and delivering diagnostic or therapeutic liquid to tissue of the blood vessel, comprising:

a) advancing within the blood vessel an elongated catheter which comprises;

an elongated catheter shaft having proximal and distal extremities and first and second lumens extending therein;

an outer inelastic inflatable member on a distal extremity of the catheter shaft with an interior in fluid communication with the first lumen within the catheter shaft and with a wall having a plurality of small apertures;

an inner inflatable member disposed within the outer inflatable member with an interior in fluid communication with the second inner lumen extending within the catheter shaft;

means on the proximal extremity of the catheter shaft to direct inflation fluid through the second inner lumen within the shaft to the interior of the inner inflatable member; and

means on the proximal extremity of the catheter shaft to direct therapeutic or diagnostic liquid through the first inner lumen within the shaft to the interior of the outer inflatable member;

b) positioning the catheter within the blood vessel so that the inner and outer inflatable members are disposed within a desired stenotic location within the blood vessel;

c) directing inflation fluid through the second inner lumen within the shaft into the interior of the inner inflatable member to inflate the inner inflatable member and thereby expand the outer inflatable member sufficiently to dilate the stenotic region of the blood vessel;

d) withdrawing inflation fluid through the second inner lumen to deflate the inner inflatable member; and

e) directing diagnostic or therapeutic liquid through the first inner lumen within the shaft into the interior of the outer inflatable member to inflate the outer inflatable member with sufficient pressure so that diagnostic or therapeutic liquid is ejected through the small apertures in the wall of the outer inflatable member in a jet-like flow of individual streams, each individual stream having sufficient velocity to pierce the tissue in the stenotic region of the blood vessel, to form a resevoir of therapeutic or diagnostic material within the tissue surrounding the body lumen.

6. The method of claim 5 wherein the volumetric flow rate of liquid being discharged out the apertures ranges from about 0.0015 to about 0.05 ml/sec.

7. The method of claim 5 wherein the velocity of the liquid being discharged from the apertures in the form of liquid jets ranges from about 3 to about 8 meters/sec.

8. The method of claim 5 wherein the wall of the outer inflatable member has about 15 to about 100 apertures per cm² of wall surface.

9. The method of claim 5 wherein the velocity of the jet-like flow is about 0.5 to about 15 meters/sec.

10. A method of delivering diagnostic or therapeutic fluids to tissue of the blood vessel, comprising:

a) advancing within the blood vessel an elongated catheter which comprises

an elongated catheter shaft having proximal and distal extremities and first and second lumens extending therein,

an outer inflatable member on a distal extremity of the catheter shaft with an interior in fluid communication with the first lumen within the catheter shaft and with a wall having a plurality of small apertures,

an inner inflatable member disposed within the outer inflatable member with an interior in fluid communication with the second inner lumen extending within the catheter shaft,

means on the proximal extremity of the catheter shaft to direct inflation fluid through the second inner lumen within the shaft to the interior of the inner inflatable member, and

means on the proximal extremity of the catheter shaft to direct therapeutic or diagnostic liquid through the first inner lumen within the shaft to the interior of the outer inflatable member;

b) positioning the catheter within the blood vessel so that the inner and outer inflatable members are disposed at a desired stenotic location within the blood vessel;

c) directing diagnostic or therapeutic liquid through the first inner lumen within the shaft into the interior of the outer inflatable member;

d) directing inflation fluid through the second inner lumen to the interior of the inner inflatable member to expand the inner inflatable member to create sufficient pressure within the outer inflatable member so that diagnostic or therapeutic liquid is ejected through the small apertures in the wall of the outer inflatable member in a jet-like fluid flow of individual streams, each individual stream having velocity sufficient to pierce the tissue surrounding the outer inflatable membe, to form a resevoir of therapeutic or diagnostic material within the tissue surrounding the body lumen; and

e) withdrawing inflation fluid through the second inner lumen to deflate the inner inflatable member.

11. The method of claim 10 wherein the velocity of the jet-like flow is about 0.5 to about 15 meters/second.

12. The method of claim 10 wherein the volumetric flow rate of liquid being discharged out the apertures in jet-like fluid flow ranges from about 0.0015 to about 0.05 ml/sec.

13. The method of claim 10 wherein the velocity of the jet-like flow is about 3 to about 8 meters/sec.