Infusion balloon catheter

• US 5,823,996 A
• Filed: 02/29/1996
• Issued: 10/20/1998
• Est. Priority Date: 02/29/1996
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Sparks, Kurt D.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/608,641
• Time in Patent Office: 964 Days
• Field of Search: 604/96, 604/101, 604/93, 604/102, 604/48, 604/53
• US Class Current: 604/103.01
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• 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 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

Apparatus and method is disclosed relating to an infusion catheter for treating a subject region with a treatment solution. A guide catheter allows the infusion catheter to be inserted into the subject and placed near a treatment region within the vascular system. A solution source is used to selectively inflate an infusion device. A passageway in the catheter body extends to an infusion device which has inner and outer chambers. Holes in a wall of the inner chamber route solution into the outer chamber and holes in the wall of the outer chamber route the solution into a subject vasculature. Solution pressure in the inner chamber is greater then the solution pressure in the outer chamber due to the relatively greater area of the holes in the outer chamber wall.

Claims

1. An infusion catheter for injecting a solution into a subject comprising:

a) an elongated catheter body for delivering a solution to an infusion site within a subject including a lumen extending from a proximally located solution input port of the elongated body to a distal end of the elongated catheter body; and

b) an infusion member attached to the elongated catheter body at a distal end of said elongated catheter body;

said infusion member defining i) an inner chamber having a chamber defining wall that includes a first set of holes spaced along said chamber defining wall and further having a solution entry in communication with the lumen of the elongated catheter body for routing solution passing through the lumen from outside a subject into the inner chamber and ii) an outer chamber having an outer chamber wall that includes a second set of holes having a greater total area than the area of the first set of holes in the chamber defining wall of the inner chamber, and where the outer chamber is supported adjacent to the inner chamber to overlap a portion of the inner chamber wall through which solution exits the inner chamber to the outer chamber by means of the first set of holes to pass through said second set of holes and enter the subject.

2. The infusion catheter of claim 1 where the inner chamber of the infusion member is bounded by an inner balloon that includes two solution confining chamber lobes connected to each other by a center section interposed between the two lobes and wherein one of the two lobes is attached to the distal end of the elongated body to form the solution entry opening of said inner chamber.

3. The infusion catheter of claim 2 wherein the outer chamber is bounded by an outer balloon that overlies an outer surface of the inner balloon and extends between the two lobes to define a solution delivery region between an inner surface of the outer chamber wall and an outer surface of the inner chamber wall.

4. The infusion catheter of claim 3 wherein an outer wall of the outer balloon is spaced from the center section of the inner balloon along the region of the center section that connects the two lobes of the inner balloon.

5. The infusion catheter of claim 1 additionally comprising a guidewire tube that extends through the infusion member and exits the infusion catheter through a side wall of the catheter body to accommodate a guidewire for use in helping position the infusion catheter within a subject vasculature.

6. The infusion catheter of claim 1 additionally comprising a guidewire tube that extends longitudinally through a center portion of the elongated catheter body and through a center of the infusion balloon to allow the guidewire to exit both a proximal and a distal end of the catheter.

7. The infusion catheter of claim 1 wherein the catheter body defines two side by side lumens and wherein one of said side by side lumens delivers solution to the infusion member and a second of the two side by side lumens is used to support a relatively rigid stiffening rod.

8. A method for constructing an infusion catheter comprising the steps of:

a) extruding a catheter body having an outer wall that bounds a solution delivery region through the catheter body;

b) providing an elongated guidewire tube having a diameter large enough to allow a guidewire to be pushed through the guidewire tube;

c) attaching the guidewire tube to the catheter body so that one end of the guidewire tube is exposed to allow a guidewire to be pushed into and through the guidewire tube for use in positioning the infusion catheter;

d) forming first and second flexible balloons and forming first and second sets of holes of different cross sectional area in side walls of said first and second flexible balloons by laser drilling said holes through a thickness of said first and second flexible balloons; and

e) attaching one end of a first balloon having a set of holes with a relatively small total cross sectional area to the guidewire tube and attaching a second end of the first balloon to the catheter body to allow solution to flow down the length of the catheter body into the said first balloon and attaching a second balloon having a set of holes with a relatively larger total cross sectional area to the first balloon to enclose a solution delivery region between the first and second balloons.

9. The method of claim 8 wherein the first and second balloons are constructed of nylon and wherein said first and second balloons are attached to each other in overlying relation by heat fusing.

10. The method of claim 8 wherein holes are drilled through the wall of the first balloon by directing a laser beam at selected spots on a wall of the first balloon and wherein holes are drilled through the wall of the second balloon by directing a laser beam to a mask having a plurality of holes to form laser beam segments and directing the laser beam segments at the wall of the second balloon.

11. A method for local delivery of solutions within a subject vasculature comprising the steps of:

a) inserting a tubular guiding catheter into the vascular system of a subject;

b) providing an infusion catheter for insertion into the guiding catheter, said infusion catheter having an inner pressure regulating balloon including first and second solution confining lobes connected to each other by an intermediate center wall portion and an outer solution delivery balloon in overlying relation to the first and second lobes of the inner balloon;

said inner balloon being attached to a catheter body to receive an amount of infusate injected at a proximal end of the infusion catheter at relatively high pressure and to transmit a controlled amount of infusate to an interior of the outer solution delivery balloon at lower pressure for delivery to a treatment site of a subject blood vessel;

c) inserting an elongated guidewire through a guidewire tube that passes through the inner and outer balloons of the infusion catheter;

d) positioning the infusion catheter relative to a treatment region of a blood vessel by pushing the combination of elongated guidewire and infusion catheter through the guide catheter; and

e) injecting a controlled amount of inflation solution through the infusion catheter body to inflate said first and second lobes of said inner pressure regulating balloon thereby fully expanding the outer balloon to bridge the first and second lobes and delivering the controlled amount of infusate at the treatment site.

12. An infusion catheter for injecting a solution into a subject comprising:

a) an elongated catheter body for delivering a solution to an infusion site within a subject including a passageway extending from a proximally located solution input port of the elongated catheter body to a distal end of the elongated catheter body;

b) an infusion balloon attached to the elongated catheter body at a distal end of said elongated catheter body;

said infusion balloon defining i) a relatively high pressure inner chamber having a chamber defining wall that includes a first set of holes spaced along said chamber defining wall and further having a solution entry in communication with the passageway of the elongated body for routing solution passing through the passageway from outside a subject into the inner chamber and ii) a lower pressure outer chamber having an outer wall that includes a second set of holes and is supported adjacent to the inner chamber to overlap a portion of the inner chamber wall through which solution exits the inner chamber to the outer chamber by means of the first set of holes to pass through said second set of holes and enter the subject;

the total area of the first set of holes in the inner, higher pressure chamber being less than the total area of the second set of holes in the outer, lower pressure chamber; and

c) solution injection means for injecting treatment solution into the catheter body for delivery to a treatment site in the subject.

13. The infusion catheter of claim 12 where a ratio of the total area of the second set of holes to the total area of the first set of holes in a range of from 10:

1 to 2000;

1.

14. The infusion catheter of claim 13 wherein the first set of holes have a total cross sectional area of between 500 and 10,000 square microns.

15. The infusion catheter of claim 13 wherein the second set of holes have a total cross sectional area of between 5000 and 1,000,000 square microns.

16. The infusion catheter of claim 12 wherein the individual holes in the first and second sets of holes are generally circular.

17. The infusion catheter of claim 12 where the high pressure inner chamber includes two solution confining chamber lobes connected to each other by a center section interposed between the two lobes and wherein one of the two lobes is attached to the distal end of the elongated body to form the solution entry of said inner, high pressure chamber.