Medical device with sensor cooperating with expandable member

• US 6,869,431 B2
• Filed: 09/07/2001
• Issued: 03/22/2005
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Picazo, Guillermo P., Lesh, Michael D., Schaer, Alan K., O'Sullivan, Martin F., Maguire, Mark A., Carcamo, Edward L., Taylor, Kevin J.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/949,479
• Publication Number:
  US 20020087156A1
• Time in Patent Office: 1,292 Days
• Field of Search: 604/96.01, 604/97.01, 604/97.02, 604/99.01, 604/103, 606/192, 606 41- 50, 607/96, 607/104, 607/105, 607/113, 607/122, 607/102
• US Class Current: 606/41
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Disclosed is a method for attaching a sensor to an inflatable balloon. The method involves bonding the sensor to the balloon with an adhesive while the balloon is in an expanded state and then collapsing the balloon after the adhesive has at least partially cured. The method reduces the possibility of a failure of the bond between the sensor and the balloon. The method is particularly useful in the construction of a tissue ablation catheter for forming a lesion along a substantially circumferential region of tissue wherein a sensor is used for monitoring the temperature of the tissue being ablated.

Claims

1. A method for attaching a sensor to a wall of an inflatable balloon having a proximal end portion and a distal end portion, comprising:

inflating the balloon by coupling a pressurizable fluid source containing a non-pyrogenic fluid to the balloon;

attaching the sensor with an adhesive to the wall of the balloon at a location between the proximal and distal end portions; and

deflating the balloon after the adhesive has at least partially cured.

2. The method of claim 1, wherein attaching the sensor comprises attaching a thermocouple to the wall of the balloon.

3. The method of claim 1, wherein inflating the balloon comprises actuating an expansion actuator.

4. The method of claim 1, wherein prior to inflating the balloon, the method further comprises inverting the balloon such that an inner surface of the wall of the balloon is exposed.

5. The method of claim 4, wherein after deflating the balloon, the method further comprises reverting the balloon such that the sensor attached to the inner surface of the wall of the balloon is inside the deflated balloon.

6. The method of claim 1, wherein after deflating the balloon, the method further comprises reverting the balloon, such that the sensor, which is attached to the wall of the balloon, is inside the deflated balloon.

7. The method of claim 1, wherein after deflating the balloon, the balloon is attached to an ablation catheter.

8. The method of claim 1, wherein the non-pyrogenic fluid is selected from the group consisting of sterile water and hydrogen peroxide.

9. A method of manufacturing an ablation catheter comprising an elongate body with an inflatable balloon having proximal and distal end portions and a sensor attached to an inner surface of a wall of the balloon, comprising:

inverting the balloon such that the inner surface of the wall of the balloon is exposed;

stretching the inverted balloon longitudinally along a tubular shaft having an inflation lumen with an inflation port, the inflation lumen being coupled to an expansion actuator;

sealably bonding the stretched balloon to the tubular shaft, wherein the proximal end portion of the balloon is bonded to the tubular shaft proximal to the inflation port and the distal end portion of the balloon is bonded to the tubular shaft distal to the inflation port;

inflating the balloon by actuating the expansion actuator;

attaching the sensor with an adhesive to the exposed inner surface of the wall of the balloon at a location between the proximal and distal end portions;

deflating the balloon after the adhesive has at least partially cured;

trimming the balloon distal to the proximal end portion and proximal to the distal end portion, such that the balloon is released from the tubular shaft to which it had been sealably bonded;

reverting the balloon, such that the sensor, which is attached to the inner surface of the wall of the balloon, is inside the balloon; and

stretching and bonding the balloon with the sensor attached to the inner surface of the wall of the balloon to the elongate body.

10. A method for attaching a sensor to a wall of an inflatable balloon having a proximal end portion and a distal end portion, comprising:

sealably bonding the balloon to a tubular shaft having an inflation lumen with an inflation port, said inflation lumen being coupled to an expansion actuator, and wherein the proximal end portion of the balloon is bonded to the tubular shaft proximal to the inflation port and the distal end portion of the balloon is bonded to the tubular shaft distal to the inflation port;

inflating the balloon;

attaching the sensor with an adhesive to the wall of the balloon at a location between the proximal and distal end portions; and

deflating the balloon after the adhesive has at least partially cured.

11. The method of claim 10, wherein prior to sealably bonding the balloon to the tubular shaft, the method further comprises inverting the balloon, such that an inner surface of the wall of the balloon is exposed.

12. The method of claim 11, wherein after deflating the balloon, the method further comprises trimming the balloon distal to the proximal end portion and proximal to the distal end portion, such that the balloon is released from the tubular shaft to which it had been sealably bonded.

13. The method of claim 12, wherein after trimming the balloon, the method further comprises reverting the balloon, such that the sensor, which is attached to the inner surface of the wall of the balloon, is inside the deflated balloon.

14. A method for attaching a sensor to a wall of an inflatable balloon having a proximal end portion and a distal end portion, comprising:

longitudinally stretching the balloon;

inflating the balloon;

attaching the sensor with an adhesive to the wall of the balloon at a location between the proximal and distal end portions; and

deflating the balloon after the adhesive has at least partially cured.