Method of delivering a therapeutic agent or diagnostic device using a micro occlusion balloon catheter

• US 5,637,086 A
• Filed: 09/07/1995
• Issued: 06/10/1997
• Est. Priority Date: 04/29/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Ferguson, Robert D. G., Tartaglino, Sandra G.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/525,318
• Time in Patent Office: 642 Days
• Field of Search: 604/49, 604/53, 604/96, 604/101, 604/102, 606/192, 606/194
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

A micro occlusion balloon catheter and methods for use and manufacture thereof, comprising an elongate member having a proximal and a distal end and a first and second lumen connected to said proximal end. The first lumen communicates with an occlusion balloon located at the distal end of the elongate member. The second lumen extends the entire length of the elongate member and allows for the placement of the catheter over a guidewire. Second lumen 15, communicates with infusion opening 17, located distal to occlusion balloon 16. A further embodiment comprises a third lumen connected to the proximal end of the elongate member. The third lumen may communicate with an infusion port located either proximally or distally to the occlusion balloon. In a still further embodiment the first lumen, the inflation/deflation balloon lumen, of the two lumen embodiment may be adapted to receive a removable stiffening stylet to ease insertion. In the three lumen embodiment, lumen one, the inflation/deflation balloon lumen, and/or the second or third infusion lumens may be proportioned so as to receive stiffening stylets.

Claims

1. A method of delivering a therapeutic agent or diagnostic device into a vessel having a diameter from about 1.5 mm to about 6.0 mm which comprises:

introducing a guide wire into a vessel;

introducing a micro occlusion balloon catheter having

a proximal end,

a distal end,

an inflatable micro occlusion balloon attached to the distal end of the balloon catheter and in fluid communication with the proximal end of the balloon catheter via a balloon inflation lumen within the balloon catheter,

an infusion lumen making a fluid path between the proximal end of the balloon catheter and a distal opening proximal to the balloon,

and a guide wire lumen from the proximal end of the balloon catheter to a distal opening distal to the balloon, wherein the infusion lumen and the inflation lumen are adapted to receive stiffening stylets,

into the vessel and over the guide wire;

inserting stiffening stylets into the infusion lumen and into the inflation lumen before or while introducing the micro occlusion balloon catheter into the vessel;

varying the stiffness of the micro occlusion balloon catheter, by inserting one of the stiffening stylets farther into the micro occlusion balloon catheter than the other, as the micro occlusion balloon catheter is advanced over the guide wire; and

removing the stiffening stylets once the micro occlusion balloon is adjacent a treatment site;

inflating the micro occlusion balloon;

removing the guide wire;

delivering a therapeutic agent or diagnostic device through the infusion lumen;

delivering a therapeutic agent or diagnostic device through the guide wire lumen;

deflating the micro occlusion balloon; and

removing the micro occlusion balloon catheter from the vessel.

2. A method of delivering a therapeutic agent or diagnostic device into a vessel having a diameter from about 1.5 mm to about 6.0 mm which comprises:

introducing a guide wire into a vessel;

introducing a micro occlusion balloon catheter having

a proximal end,

a distal end,

an inflatable micro occlusion balloon attached to the distal end of the balloon catheter and in fluid communication with the proximal end of the balloon catheter via a balloon inflation lumen within the balloon catheter,

an infusion lumen making a fluid path between the proximal end of the balloon catheter and a distal opening proximal to the balloon,

and a guide wire lumen from the proximal end of the balloon catheter to a distal opening distal to the balloon, wherein the infusion lumen and the inflation lumen are adapted to receive stiffening stylets,

into the vessel and over the guide wire;

inflating the micro occlusion balloon;

removing the guide wire;

delivering a therapeutic agent or diagnostic device through the infusion lumen wherein the therapeutic agent is an embolic agent selected from the group consisting of ethanol, polyvinyl acetate particles, coils, glue and gel foam;

delivering a therapeutic agent or diagnostic device through the guide wire lumen wherein the therapeutic agent is an embolic agent selected from the group consisting of ethanol polyvinyl acetate particles, coils, glue and gel foam;

deflating the micro occlusion balloon; and

removing the micro occlusion balloon catheter from the vessel.

3. A method of delivering a therapeutic agent or diagnostic device into a vessel having a diameter from about 1.5 mm to about 6.0 mm which comprises:

introducing a guide wire into a vessel;

introducing a micro occlusion balloon catheter having

a proximal end,

a distal end,

an inflatable micro occlusion balloon attached to the distal end of the balloon catheter and in fluid communication with the proximal end of the balloon catheter via a balloon inflation lumen within the balloon catheter,

an infusion lumen making a fluid path between the proximal end of the balloon catheter and a distal opening proximal to the balloon,

and a guide wire lumen from the proximal end of the balloon catheter to a distal opening distal to the balloon, wherein the infusion lumen and the inflation lumen are adapted to receive stiffening stylets,

into the vessel and over the guide wire;

inflating the micro occlusion balloon;

removing the guide wire;

delivering a therapeutic agent or diagnostic device through the infusion lumen wherein the therapeutic agent is an thrombolytic agent selected from the group consisting of streptokinase, urokinase, and tissue plasminogen activator;

delivering a therapeutic agent or diagnostic device through the guide wire lumen wherein the therapeutic agent is an thrombolytic agent selected from the group consisting of streptokinase, urokinase, and tissue plasminogen activator;

deflating the micro occlusion balloon; and

removing the micro occlusion balloon catheter from the vessel.