Coaxial PTCA catheter with anchor joint

• US 6,179,856 B1
• Filed: 12/19/1997
• Issued: 01/30/2001
• Est. Priority Date: 07/05/1989
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Barbere, Michael D.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/994,697
• Time in Patent Office: 1,138 Days
• Field of Search: 606/194, 606/192, 606/193, 606/195, 604/96-103
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon dilatation catheter used for percutaneous transluminal coronary angioplasty includes a coaxial construction of an inner tube and an outer tube. The inner tube extends distally beyond the distal end of the outer tube. A dilatation balloon is mounted on the distal end of the catheter and is connected at its proximal end to the distal end of the outer tube and at its distal end to the distal end of the inner tube. The lumen of the inner tube is adapted to receive a guidewire and may permit pressure monitoring and liquid infusion. The annular inflation lumen is defined between the inner and outer tubes. The distal end of the outer tube extends into the balloon and is anchored directly to the inner tube. The balloon may be inflated and deflated through an annular inflation lumen defined between the inner and outer tubes, there being openings in the outer tube within the balloon to communicate the inflation lumen with the interior of the balloon. The catheter displays increased column strength and resistance to axial buckling and balloon bunching by reason of the secure connection between the distal end of the outer tube and the inner tube.

Claims

1. A balloon dilatation catheter comprising:

an elongate, flexible catheter shaft including a two tube, two lumen configuration, the shaft having a proximal region, a proximal end, and a distal end, wherein the two tube, two lumen configuration includes an inner tube defining a guidewire lumen therethrough, and a surrounding outer tube defining an annular inflation lumen therebetween, the inner tube being of smaller diameter than the outer tube and having a distal end region extending distally of a distal end of the outer tube;

an inflatable dilatation balloon having a proximal end and a distal end, the proximal end of the balloon being attached to the outer tube adjacent the distal end of the outer tube, the distal end of the balloon being attached to the distal end region of the inner tube at a distal connection;

the outer tube being attached to the inner tube at a location between a proximal end of the two tube, two lumen configuration and said distal connection to resist axial telescoping of the inner tube with respect to the outer tube when the catheter is advanced against a resistance encountered adjacent to the distal end of the catheter, wherein the outer tube and the inner tube are unattached for a portion of the two tube, two lumen configuration between the proximal end of the two tube, two lumen configuration and said location, the outer tube terminating proximally of said distal connection;

means for communicating the annular inflation lumen with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon; and

means at the proximal end of the catheter for accessing the inflation lumen.

2. A balloon dilatation catheter as defined in claim 1 wherein the outer tube is attached to the inner tube by an adhesive.

3. A balloon dilatation catheter having an elongate, flexible catheter shaft and a balloon mounted on the shaft, the shaft having a proximal region, a proximal end, and a distal end, at least a distal portion of the shaft including a two tube, two lumen arrangement in which an inner tube defines a guidewire lumen and has a distal region extending distally of a distal region of a surrounding outer tube, a proximal end of the balloon being attached to the distal region of the outer tube, a distal end of the balloon being attached to the distal region of the inner tube at a distal connection, an inflation lumen being between the inner and outer tubes in communication with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon, and a fitting at the proximal end of the catheter to facilitate access to the inflation lumen, the improvement comprising:

the outer tube being attached to the inner tube at a location between a proximal end of the two tube, two lumen arrangement and said distal connection to resist axial telescoping of the inner tube with respect to the outer tube when the catheter is advanced against a resistance encountered adjacent to the distal end of the catheter, wherein the outer tube and the inner tube are unattached for a portion of the two tube, two lumen arrangement between the proximal end of the two tube, two lumen arrangement and said location.

4. A balloon dilatation catheter having an elongate, flexible catheter shaft and a balloon mounted on the shaft, the shaft having a proximal region, a proximal end, and a distal end, at least a distal portion of the shaft including a two tube, two lumen arrangement in which an inner tube defines a guidewire lumen and has a distal region extending distally of a distal region of a surrounding outer tube, a proximal end of the balloon being attached to the distal region of the outer tube, a distal end of the balloon being attached to the distal region of the inner tube at a distal connection, an inflation lumen being between the inner and outer tubes in communication with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon, and a fitting at the proximal end of the catheter to facilitate access to the inflation lumen, the improvement comprising:

an anchor joint attaching the inner and outer tubes at a location distal of a proximal end of the two tube, two lumen arrangement sufficiently close to the distal connection to resist axial buckling of the balloon when the catheter is advanced against a resistance encountered adjacent to the distal end of the catheter, wherein the outer tube and the inner tube are unattached for a portion of the two tube, two lumen arrangement between the proximal end of the two tube, two lumen arrangement and said anchor joint.

5. A balloon dilatation catheter having an elongate, flexible catheter shaft and a balloon mounted on the shaft, the shaft having a proximal region, a proximal end, and a distal end, at least a distal portion of the shaft including a two tube, two lumen arrangement in which an inner tube defines a guidewire lumen and has a distal region extending distally of a distal region of a surrounding outer tube, a proximal end of the balloon being attached to the distal region of the outer tube, a distal end of the balloon being attached to the distal region of the inner tube at a distal connection, an inflation lumen being between the inner and outer tubes in communication with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon, and a fitting at the proximal end of the catheter to facilitate access to the inflation lumen, the improvement comprising:

means located distally of a proximal end of the two tube, two lumen arrangement for resisting longitudinal buckling of the balloon when the catheter is advanced against a resistance encountered adjacent to the distal end of the catheter, wherein the outer tube and the inner tube are unattached for a portion of the two tube, two lumen arrangement between the proximal end of the two tube, two lumen arrangement and said means for resisting longitudinal buckling.

6. A two tube, two lumen balloon dilatation catheter comprising:

an elongate, flexible catheter shaft having a proximal region, a proximal end, and a distal end, wherein the shaft is formed from an inner tube defining a guidewire lumen therethrough, and a surrounding outer tube defining an annular inflation lumen therebetween, the inner tube being of smaller diameter than the outer tube and having a distal end region extending distally of a distal region of the outer tube;

an inflatable dilatation balloon having a proximal end and a distal end, the proximal end of the balloon being attached to the distal region of the outer tube, the distal end of the balloon being attached to the distal end region of the inner tube at a distal connection;

the outer tube being attached to the inner tube at a location between a proximal end of the two tube, two lumen catheter and said distal connection to resist axial telescoping of the inner tube with respect to the outer tube when the catheter is advanced against a resistance encountered adjacent to the distal end of the catheter, the outer tube terminating proximally of said distal connection, wherein the outer tube and the inner tube are unattached for a portion of the two tube, two lumen catheter between the proximal end of the two tube, two lumen catheter and said location;

the annular inflation lumen being in communication with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon; and

the proximal end of the catheter having an opening for accessing the inflation lumen.

7. The catheter defined in claim 6 further comprising an opening at the proximal end of the catheter lumen for accessing the guidewire lumen.

8. A balloon dilation catheter comprising:

an elongate, flexible catheter shaft including a two tube, two lumen configuration, the shaft having a proximal region, a proximal end and a distal end, wherein the two tube, two lumen configuration includes an inner tube defining a guidewire lumen therethrough, and a surrounding outer tube defining an annular inflation lumen therebetween, the inner tube being of smaller diameter than the outer tube and having a distal end region extending distally of a distal end of the outer tube;

an inflatable dilatation balloon having a proximal end and a distal end, the proximal end of the balloon being attached to the outer tube adjacent the distal end of the outer tube, the distal end of the balloon being attached to the distal end region of the inner tube at a distal connection;

the outer tube being attached to the inner tube at a location within an inflatable portion of the balloon to resist axial telescoping of the inner tube with respect to the outer tube when the catheter is advanced against a resistance encountered adjacent the distal end of the catheter, the outer tube terminating proximally of said distal connection;

means for communicating the annular inflation lumen with an interior of the balloon to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon; and

means at the proximal end of the catheter for accessing the inflation lumen.

10. A catheter as defined in either one of claims 8 further comprising:

a tubular spacer interposed between the inner and outer tubes at the end of the inflation lumen, the tubular spacer being attached to each of the inner and outer tubes to define the point of attachment of the inner and outer tubes.

11. A balloon dilatation catheter as defined in claim 10 wherein the inner tube is formed from a high density polyethylene and the surrounding outer tube is formed from a linear low density polyethylene.

9. A balloon dilation catheter comprising:

an elongate, flexible catheter shaft including a two tube, two lumen configuration, the shaft having a proximal region, a proximal end and a distal end, wherein the two tube, two lumen coaxial configuration includes an inner tube defining a guidewire lumen therethrough, and a surrounding outer tube defining an annular inflation lumen therebetween, the inner tube being of smaller diameter than the outer tube and having a distal end region extending distally of a distal end of the outer tube;

an inflatable dilatation balloon having a proximal end and a distal end, the proximal end of the balloon being attached to the outer tube adjacent the distal end of the outer tube, the distal end of the balloon being attached to the distal end region of the inner tube at a distal connection;

the outer tube being attached to the inner tube at a location between a the proximal region of the catheter shaft and said distal connection to resist axial telescoping of the inner tube with respect to the outer tube when the catheter is advanced against a resistance encountered adjacent the distal end of the catheter, the outer tube terminating proximally of said distal connection;

means for communicating the annular inflation lumen with an interior of the balloon comprising at least one aperture associated with the outer tube to facilitate inflation and deflation of the balloon, the inflation lumen comprising the sole lumen in communication with the interior of the balloon; and

means at the proximal end of the catheter for accessing the inflation lumen,

wherein a portion of the outer tube is disposed within the balloon and wherein the at least one aperture is formed in the portion of the outer tube that is disposed within the balloon.

12. A balloon dilatation catheter as defined in claim 9 wherein the inner tube is formed from a high density polyethylene and the surrounding outer tube is formed from a linear low density polyethylene.