Readily exchangeable perfusion dilatation catheter

• US 5,516,336 A
• Filed: 01/18/1994
• Issued: 05/14/1996
• Est. Priority Date: 02/07/1990
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: McInnes, Peter R., Sirhan, Motasim M.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/183,574
• Time in Patent Office: 847 Days
• Field of Search: 606/192-194, 604/96, 604/101, 604/102
• US Class Current: 606/194
• 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 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A perfusion-type dilatation catheter which can be rapidly exchanged for another catheter without the need for exchange wires or guidewire extension wires. The dilatation catheter has an elongated catheter body with a distal guidewire port in the distal end of the catheter and a proximal guidewire port at least 10 cm but not more than 50 cm from the distal port. The catheter body has a first inflation lumen which extends from the proximal end of the catheter body to the interior of a dilatation balloon adjacent the distal end of the catheter body. A second, much shorter inner lumen is disposed between the proximal and distal guidewire ports and is adapted to slidably receive a guidewire. A plurality of perfusion ports are provided both proximal and distal to the balloon which are in fluid communication with the second inner lumen so that when the balloon is inflated within a patient'"'"'s vascular system, blood will flow through the proximal perfusion ports and the second inner lumen and out the distal perfusion ports to minimize ischemic conditions distal to the catheter. A stiffening member is disposed within the catheter body proximal to the proximal guidewire port to provide improved pushability. The distal portion of the inflation lumen should have a transverse cross-sectional area of about 3 to about 20×10^-5 inch² and should not be greater than one-third the cross-sectional area of the perfusion lumen.

Claims

1. A balloon catheter which may be rapidly advanced over a guidewire into a patient'"'"'s coronary artery and which is adapted to perfuse oxygenated blood distal to the catheter, comprising:

a) an elongated catheter body having proximal and distal ends with a stiff proximal portion and a flexible distal portion much shorter than the proximal portion;

b) an inflatable balloon member which has proximal and distal skirts and an interior and which is secured by said skirts to the flexible distal portion of the catheter body proximally adjacent the distal end of the catheter body,

c) a distal guidewire port in the distal end of the catheter body and a proximal guidewire port in the catheter which is disposed a short distance proximally from the inflatable balloon member and a substantial distance distally from the proximal end of the catheter body;

d) a short inner lumen which is configured to slidably receive a guidewire and which extends within the flexible distal portion of the catheter body between the distal guidewire port in the distal end of the catheter body and the proximal guidewire port; and

e) a long inner lumen disposed within the catheter body

which is adapted to direct inflation fluid from the proximal end of the catheter body to the interior of the inflatable balloon member,

which has a proximal section with a transverse cross-section, and

which has a distal section much shorter than the proximal section extending within the flexible distal portion of the catheter body, having a transverse cross-sectional area of at least 3×

10^-5 to not more than about 20×

10^-5 inch² and substantially less than the transverse cross-sectional area of the proximal section of the long inner lumen in the proximal portion of the catheter shaft and extending at least 10 cm proximally from the inflatable balloon member; and

f) at least one proximal perfusion port in the distal portion of the catheter body which is in fluid communication with the inner lumen adapted to receive a guidewire and which is located between the proximal guidewire port and the inflatable balloon member.

2. The balloon dilatation catheter of claim 1 wherein the portion of the long inner lumen having a transverse cross-sectional area of at least 3×

10^-5 to not more than about 20×

10^-5 inch² extends within the last 30 cm of the flexible distal portion.

3. A balloon catheter for rapid advancement over a guidewire into a patient'"'"'s coronary artery which is adapted to perfuse oxygenated blood distal to the catheter, comprising:

a) an elongated catheter body having proximal and distal ends with a proximal portion and a distal portion, the distal portion having a length of at least 10 cm and being substantially more flexible than the proximal portion;

b) an inflatable balloon member which has an interior and which is located on the distal portion of the elongated catheter body proximally adjacent the distal end of the catheter body,

c) a short first inner lumen configured to slidably receive a guidewire which extends within the distal portion of the elongated catheter body between a distal guidewire port in the distal end of the catheter body and a proximal guidewire port in the elongated catheter body which is disposed a short distance proximally from the inflatable balloon member and a substantial distance distally from the proximal end of the elongated catheter body;

d) a long second inner lumen disposed within the elongated catheter body which is adapted to direct inflation fluid from the proximal end of the elongated catheter body to the interior of the inflatable balloon member, the last 10 cm of the second inner lumen within the distal portion of the elongated catheter body proximal to the inflatable member having a transverse cross-sectional area which is not greater than one-third of the transverse cross-sectional area of the first inner lumen co-extending with the second inner lumen in the distal portion proximal to the inflatable balloon member and which is substantially smaller than a transverse cross-sectional area of the second inner lumen in the proximal portion of the elongated catheter body; and

e) at least one proximal perfusion port in the distal portion of the elongated catheter body which is in fluid communication with the inner lumen adapted to receive a guidewire and which is located between the proximal guidewire port and the inflatable balloon member.

4. The balloon catheter of claim 3 wherein the first inner lumen having a transverse cross-sectional area of not greater than one-third of the transverse cross-sectional area of the portion of the inner lumen in the flexible distal portion adapted to receive a guidewire which is co-extensive therewith has a length of less than 20 cm.

5. A balloon catheter for rapid advancement over a guidewire into a patient'"'"'s coronary artery which is configured to perfuse oxygenated blood distal to the catheter, comprising:

a) an elongated catheter body having proximal and distal ends, a distal guidewire port in the distal end, a proximal guidewire port space a short distance from the distal end and a substantial distance from the proximal end, a proximal portion and a distal portion which is substantially shorter and more flexible than the proximal portion and which extends at least 10 cm to the distal end of the catheter body;

b) an inflatable balloon member which is located on the distal portion of the elongated catheter body spaced from the distal end thereof and which has an interior;

c) a guidewire receiving lumen configured to slidably receive a guidewire which extends within the catheter body between the distal guidewire port and the proximal guidewire port and is in fluid communication therewith;

d) an inflation lumen which extends within the catheter body from the proximal end of the catheter body to a location in the distal portion spaced from the distal end of the catheter body in fluid communication with the interior of the balloon and which has a portion extending within at least the last 10 cm of the distal portion of the catheter body proximal to the balloon having a transverse cross-sectional area which is substantially smaller than a transverse cross-sectional area of the inflation lumen in the proximal portion of the catheter body and which is not greater than about one-third of the transverse cross-sectional area of a portion of the guidewire receiving lumen extending within the distal portion of the catheter body proximal to the balloon; and

e) at least one proximal perfusion port in the distal portion of the catheter body which is in fluid communication with the inner lumen adapted to receive a guidewire and which is located in the portion of the catheter body which has the inflation lumen with a transverse cross-sectional area of not greater than about one third of the portion of the guidewire receiving lumen extending within the distal portion of the catheter body between the proximal guidewire port and the inflatable balloon member.

6. The balloon catheter of claim 5 wherein the distal portion of the catheter body has a length of at least 30 cm and the inflation lumen in the last 30 cm of the distal portion has a transverse cross-sectional area which is not greater than one-third of the transverse cross-sectional area of the inner lumen in the flexible distal portion adapted to receive a guidewire and which is substantially smaller than the cross-sectional area of the inflation lumen proximal thereto.

7. A balloon catheter for rapid advancement over a guidewire into a patient'"'"'s coronary artery which is adapted to perfuse oxygenated blood distal to the catheter, comprising:

a) an elongated catheter body having proximal and distal ends with a proximal body portion and a distal body portion, the distal body portion having a length of about 10 to about 50 cm and being substantially more flexible than the proximal body portion;

b) an inflatable balloon member which has an interior and which is located on the distal body portion proximally adjacent the distal end of the catheter body,

c) a short first inner lumen configured to slidably receive a guidewire which extends within the distal body portion between a distal guidewire port in the distal end of the catheter body and a proximal guidewire port in the elongated catheter body which is disposed a short distance proximally from the inflatable balloon member and a substantial distance distally from the proximal end of the elongated catheter body;

d) a plurality of proximal perfusion ports in the distal body portion which are in fluid communication with the short first inner lumen and which are located between the proximal guidewire port and the inflatable balloon member; and

e) a long second inner lumen disposed within the elongated catheter body

adapted to direct inflation fluid from the proximal end of the elongated catheter body to the interior of the inflatable balloon member,

having a lumen section within the proximal body portion with a transverse cross-sectional area over a substantial length of the proximal body portion,

having a lumen section not longer than about 30 cm within the distal body portion distal to the proximal guidewire port and proximal to the inflatable member with a transverse cross-sectional area not greater than one-third of the transverse cross-sectional area of the first inner lumen co-extending at least in part with the plurality of perfusion ports and substantially smaller than a transverse cross-sectional area of a substantial part of the second inner lumen in the proximal portion of the elongated catheter body.

8. The balloon catheter of claim 7 wherein the lumen section not within the distal body portion distal to the proximal guidewire port and proximal to the inflatable member with a transverse cross-sectional area not greater than one-third of the transverse cross-sectional area of the first inner lumen co-extending at least in part therewith is not longer than 20 cm.