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EP0383429A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Catheter and method for locally applying medication to the wall of a blood vessel or other body lumen

Assignee: Medtronic Vascular Inc
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Filing: 1990-01-16
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Granted: —
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Expires: 2010-01-16
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Abstract

Abstract A method and catheter for use in practising the method are provided by which a highly concentrated medication or chemotherapeutic agent can be applied locally under sufficient pressure to cause the medication or agent to penetrate into the localized tissue. The total volume of medication or agent is quite small, well below levels that might cause an adverse reaction in other parts of the body. The catheter includes a thin walled flexible balloon (16) having a plurality of minute holes (29) through which medication may flow at a low flow rate. The balloon (16) is inflated with the medication under pressure and the low flow rate of the order of a few ccs per minute is controlled by the minute holes (29) in the balloon (16). In practising the method of the invention, the balloon (16) is selected such that its inflated diameter will correspond to or be slightly greater than the diameter of the lumen into which it is to be placed so that when the balloon (16) is inflated, it will contact intimately the surface of the lumen. Inflation of the balloon (16) with the medication will cause a thin film to spread between the balloon (16) and the lumen, the film being maintained under a sufficient pressure to penetrate significantly the surrounding tissue with a high concentration of medication. The quantity of medication that ultimately flows free into the lumen is quite small and is insufficient to cause any other damage to the patient.

Inventors

  • 👤 Harvey Wolinsky
  • 👤 Michael D. Barbere
  • 👤 Spencer L. King

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-05 22:06
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/105; A61M25/1027

Claims Analysis

Total Claims: 12
Claim 1
Independent Claim 126 words
A catheter for applying concentrated medication to a surface of the lumen of the body vessel and for effecting penetration of the medication into the body vessel comprising: an elongate flexible shaft having a proximal end and a distal end and having an inflation lumen extending from its proximal to its distal end; a balloon mounted at the distal end of the shaft, tie balloon being flexible, and substantially inelastic, the balloon having a plurality of minute perforations adapted to provide a low, weeping flow rate no greater than a predetermined maximum flow rate; said perforations defining a flow area sufficiently small so as not to adversely restrict collapsing of the balloon about the catheter shaft under the influence of aspiration applied to the inflation lumen.
Claim 2
Dependent Claim 126 words
A catheter for applying concentrated medication to a surface of the lumen of the body vessel and for effecting penetration of the medication into the body vessel comprising: an elongate flexible shaft having a proximal end and a distal end and having an inflation lumen extending from its proximal to its distal end; a balloon mounted at the distal end of the shaft, tie balloon being flexible, and substantially inelastic, the balloon having a plurality of minute perforations adapted to provide a low, weeping flow rate no greater than a predetermined maximum flow rate; said perforations defining a flow area sufficiently small so as not to adversely restrict collapsing of the balloon about the catheter shaft under the influence of aspiration applied to the inflation lumen.
Claim 3
Dependent Claim 29 words
A catheter as defined in claim 1 wherein the maximum flow rate of saline solution through the perforation is about 12 cc per minute at about 5 atmospheres pressure.
Claim 4
Dependent Claim 22 words
A catheter as defined in claims 1 or 2 wherein the wall thickness of the balloon is no greater than about .001".
Claim 5
Dependent Claim 15 words
A catheter as defined in claim 3 wherein the balloon is formed from polyethylene terephthalate.
Claim 6
Dependent Claim 33 words
A catheter as defined in claim 1 wherein the balloon is provided with about thirty holes substantially regularly spaced about the balloon and each having a diameter of the order of 25 microns.
Claim 7
Dependent Claim 24 words
A catheter as defined in claim 5 wherein the catheter is dimensioned and adapted to be percutaneously inserted and advanced into the coronary arteries.
Claim 8
Dependent Claim 31 words
A catheter as defined in any of claims 1 to 6 wherein the balloon includes a cylindrical perforated surface having an annular portion at each end that is free of perforations.
Claim 9
Dependent Claim 137 words
A method for causing a concentrated medication to penetrate tissue defining a body lumen comprising: selecting a catheter as defined in claim 1 in which the inflated diameter of the balloon is no less than the diameter of the lumen; inserting the catheter into the patient to locate the balloon in the lumen; inflating the balloon in the body lumen so that it presses in intimate contact against the inner surface of the body lumen; maintaining fluid pressure for a predetermined time to cause liquid to weep out of the holes in the balloon to form a thin film between the balloon and the lumen, the pressure level in the film being such as to force fluid to perfuse into the tissue; after a predetermined time, aspirating the balloon to deflate the balloon and remove the catheter.
Claim 10
Dependent Claim 32 words
A method as defined in claim 8 wherein the pressure is not maintained beyond tie time that the maximum amount of medication tolerable by the patient has wept through the balloon holes.
Claim 11
Dependent Claim 51 words
A method as defined in claim 8 wherein the body lumen is an artery and further comprising first performing an angioplasty in the artery and then performing the perfusion with said catheter, the balloon of the catheter being the same diameter as the balloon of the catheter that performed the angioplasty.
Claim 12
Dependent Claim 17 words
A method as defined in claim 10 wherein the perforated balloon. is inflated with concentrated heparin solution.

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