Low profile dilatation catheter

• US 5,496,275 A
• Filed: 02/04/1994
• Issued: 03/05/1996
• Est. Priority Date: 05/15/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Fernando, Jovito L., Sirhan, Motasim M.
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/192,065
• Time in Patent Office: 760 Days
• Field of Search: 128/772, 128/656-658, 606/192-194, 604/43, 604/96-103, 604/173, 604/258, 604/264, 604/280, 604/282
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• 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 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• 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 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular catheter, such as a balloon dilatation catheter, which has a distal section wherein a small dimensioned distal section of an outer tubular member is bonded to an inner tubular member over a significant portion thereof to provide a catheter shaft having small transverse dimensions and improved flexibility with little or no loss is pushability. The catheter construction can be employed in a wide variety of catheters.

Claims

1. An elongated catheter for performing an intravascular procedure comprising:

a) an elongated catheter shaft which has a distal section with an inner tubular member having a first inner lumen and a distal end with a port in communication with the first inner lumen and an outer tubular member disposed about the inner tubular member having about 30% to about 90% of the inner periphery thereof along a length of the distal section of at least about 10 cm taking the shape of and being secured to the exterior of the inner tubular member and the outer tubular member having along said length a portion unsecured to the exterior of the inner tubular member, being longitudinally off-set and coextensive with the portion secured and having a second inner lumen extending longitudinally between the inner tubular member and the unsecured portion of the outer tubular member, a transverse cross-section of the distal section along the said length being substantially larger in a first direction than in a second direction perpendicular to the first direction; and

b) means for performing a vascular procedure on the catheter shaft at a location distal to at least a portion of said length.

2. The elongated catheter of claim 1 wherein at least one perfusion port extends through secured walls of the outer tubular member and the inner tubular member and is in fluid communication with the inner lumen of the inner tubular member.

3. The elongated catheter of claim 2 wherein at least one perfusion port is provided in the inner tubular member distal to the balloon which is in fluid communication with the inner lumen thereof.

4. The elongated catheter of claim 1 wherein at least about 30% to about 80% of the inner periphery of the section of the outer tubular member is bonded to the exterior of the inner tubular member.

5. The elongated catheter of claim 1 wherein a portion of the inner tubular member proximal to the portion thereof which is secured to the outer tubular member in the distal shaft section is formed of hypotubing.

6. The elongated catheter of claim 1 including an inflatable balloon at a location distal to the secured section and having an interior in fluid communication with the second inner lumen.

7. The elongated catheter of claim 1 wherein a portion of the inner tubular member proximal to the portion thereof secured to the outer tubular is provided with a stiffening member.

8. The elongated catheter of claim 7 wherein the stiffening member is a stiffening mandrel and is disposed within the inner lumen of the inner tubular member.

9. The elongated catheter of claim 1 including a guidewire receiving port which is located proximal to the means for performing an intravascular procedure and which is in communication with the inner lumen of the inner tubular member.

10. A balloon dilatation catheter for performing an angioplasty procedure within a patient'"'"'s arterial system comprising:

a) an elongated catheter body having

an inner tubular member with a first inner lumen extending therethrough and a distal end with a port in fluid communication with the first inner lumen, both of which are adapted to slidably receive a guidewire therein, and

an outer tubular member which is disposed about the inner tubular member and which has a length of at least about 10 cm in a distal portion of the catheter body with about 30% to about 90% of an inner periphery thereof along the length taking the shape of and being secured to the exterior of an underlying portion of the inner tubular member and with portion of the outer tubular member along the length being unsecured to the inner tubular member and providing a passageway which is in fluid communication with an inflation port at a location proximal to the distal end, the outer tubular member in the length where secured to the inner tubular member having a transverse cross-sectional dimension in a first direction being substantially larger than a transverse cross-sectional dimension in a second direction perpendicular to the first direction;

b) an inflatable dilatation balloon on the elongated catheter shaft which is distal to the portion of the outer tubular member secured to the inner tubular member and which has an interior in fluid communication with the passageway through the inflation port and which has a distal end sealingly secured to a distal portion of the inner tubular member extending through the interior of the balloon; and

c) means on the proximal end of the catheter shaft to direct inflation fluid from a source through the passageway into the interior of the inflatable dilatation balloon.

11. The dilatation catheter of claim 10 wherein not more than about 80% of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member along the length thereof secured to the inner tubular member.

12. The dilatation catheter of claim 11 wherein the portion of the outer tubular member secured to the outer periphery of the inner tubular member has a length of not more than about 40 cm.

13. The dilatation catheter of claim 10 wherein a guidewire receiving port extends through the secured portions of the inner tubular member and the outer tubular member and is in communication with the inner lumen of the inner tubular member.

14. The dilatation catheter of claim 10 wherein at least one perfusion port extends through the secured portions of the inner tubular member and the outer tubular member and is in communication with the inner lumen of the inner tubular member.

15. The dilatation catheter of claim 14 wherein at least one perfusion port is provided in the inner tubular member distal to the balloon which is in communication with the inner lumen thereof.

16. The dilatation catheter of claim 10 wherein a portion of the inner tubular member proximal to the portion thereof secured to the outer tubular is provided with a stiffening element.

17. The dilatation catheter of claim 16 wherein a portion of the inner tubular member proximal to the portion thereof which is secured to the outer tubular member is formed of hypotubing to increase the stiffness of the inner tubular member.

18. The dilatation catheter of claim 16 wherein the stiffening member is a mandrel which is disposed within the inner lumen of the inner tubular member.

19. A balloon dilatation catheter for performing angioplasty procedures within a patient'"'"'s arterial system, comprising:

a) an elongated catheter body having

an inner tubular member with an inner lumen extending therethrough, which is relatively short in comparison with the elongated catheter body, and a distal end with a first port in communication with the inner lumen, both of which are adapted to slidably receive a guidewire therein, and

an outer tubular member which is disposed about the inner member and which has a length of at least about 10 cm in the distal portion of the catheter body having about 30% to about 90% of an inner periphery thereof taking the shape of and being secured to an outer periphery of an underlying portion of the inner tubular member and a portion of the outer tubular member not secured to the outer periphery of the inner tubular member providing a passageway which is in fluid communication with an inflation port at a location proximal to the distal end, the outer tubular member along said length having a first transverse cross-sectional dimension in a first direction which is substantially larger than in a second transverse cross-sectional dimension in a second direction perpendicular to the first direction;

b) an inflatable dilatation balloon located on a distal portion of the catheter shaft;

c) a second guidewire port which is disposed proximal to the inflatable dilatation balloon and which is in communication with the inner lumen of the inner tubular member; and

d) means to direct inflation fluid from a source through the passageway between the portion of the outer tubular member which is not secured to the inner tubular member along said length and the underlying inner tubular member into the interior of the balloon.

20. The dilatation catheter of claim 19 wherein not more than about 80% of the inner periphery of the outer tubular member along said length takes the shape of and is secured to the outer periphery of the inner tubular member.

21. The balloon dilatation catheter of claim 19 wherein the portion of the outer tubular member secured to the outer periphery of the inner tubular member has a length of not more than about 40 cm.

22. The dilatation catheter of claim 19 wherein not more than about 80% of the inner periphery of the secured length of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member.

23. The dilatation catheter of claim 19 wherein the catheter body has a relatively stiff proximal portion and a relatively flexible distal portion.

24. The dilatation catheter of claim 19 wherein the proximal portion of the outer tubular member is hypotubing.

25. A balloon dilatation catheter for performing angioplasty procedures within a patient'"'"'s arterial system, comprising:

a) an elongated catheter body having an inner tubular member with an inner lumen extending therein and an outer tubular member which is disposed about the inner tubular member and which has a length of at least about 10 cm in a distal portion of the catheter body having about 30% to about 90% of an inner periphery thereof taking the shape of and being secured to an outer periphery of an underlying portion of the inner tubular member and a passageway disposed between a portion of the outer tubular member not secured to the outer periphery of and the inner tubular member along said length, the outer tubular member along said length having a transverse cross-sectional dimension in a first direction which is substantially larger than a transverse cross-sectional dimension in a second direction perpendicular to the first direction;

b) an inflatable dilatation balloon on a distal portion of the catheter body which has a distal end secured to the distal end of the inner tubular member which extends through the interior of the balloon;

c) at least one perfusion port which extends through walls of the inner and outer tubular members secured together and which is in communication with the inner lumen of the inner tubular member; and

d) means to direct inflation fluid from a source through the passageway between the the outer tubular member and the inner tubular member and into the interior of the balloon.

26. The elongated catheter of claim 25 wherein the portion of the outer tubular member secured to the outer periphery of the inner tubular member has a length of not more than about 40 cm.

27. An elongated dilatation catheter for performing angioplasty procedures comprising:

a) an elongated catheter shaft with a flexible distal section having a length of about 10 to about 40 cm, having a first longitudinally extending inner lumen in fluid communication with a port in the distal end of the catheter shaft, wherein both the inner lumen and the port are adapted to receive a guidewire, a second inner lumen which extends longitudinally and generally parallel with the first inner lumen, with one transverse dimension of the catheter shaft in the distal section in a first direction being substantially larger than a second transverse dimension of the catheter shaft in the distal section in a second direction perpendicular to the first direction, one of the inner lumens being disposed above the other inner lumen in the direction of the larger dimension; and

b) inflatable means for dilating a stenosis which has an interior in fluid communication with the second inner lumen and which is mounted on a distal portion of the catheter shaft.

28. An elongated catheter for performing an intravascular procedure comprising:

a) an elongated catheter shaft with a flexible distal section having a length of at least about 10 cm, having a first longitudinally extending inner lumen in fluid communication with a port in the distal end of the catheter shaft, wherein both the inner lumen and the port are adapted to receive a guidewire, a second inner lumen which extends longitudinally and generally parallel with the first inner lumen, with one transverse dimension of the catheter shaft in the distal section in a first direction being substantially larger than a second transverse dimension of the catheter shaft in the distal section in a second direction perpendicular to the first direction, one of the inner lumens being disposed above the other inner lumen in the direction of the larger transverse dimension; and

b) means for performing an intravascular procedure on a distal portion of the catheter shaft proximal to the distal end thereof.