Pressure sensor for therapeutic delivery device and method

• US 7,211,063 B2
• Filed: 12/30/2003
• Issued: 05/01/2007
• Est. Priority Date: 03/23/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Tom, Curtis P.
• Primary Examiner(s): Ganey; Steven J.
• Application Number:
  US10/749,327
• Publication Number:
  US 20040225298A1
• Time in Patent Office: 1,218 Days
• Field of Search: 604/65, 604/66, 604/67, 607/120, 607/122, 606/108, 600/466
• US Class Current: 604/65
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/3494 with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors for the peridural space A61B17/3401
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/348 Means for supporting the trocar against the body or retaining the trocar inside the body
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

The present invention is an apparatus for treating a selected patient tissue or organ region, at the surface of such region. The apparatus has an accessing tool for accessing the patient region, the tool having a distal end, and a proximal end at which the tool can be manipulated to place the distal end adjacent to the patient region. The apparatus also has a probe carried on the distal end and defining a contact surface that may be urged against the patient region thereby creating contact pressure. A pressure transducer is operatively coupled to the probe and is capable of producing a measurable response to the contact pressure. A monitoring device is operatively connected to the pressure transducer, for determining the contact pressure. An effector is operatively disposed on the probe for producing a given effect on the patient region when the effector is activated, and an activator operatively connected to the effector, by which the effector can be activated.

Claims

1. A method of positioning a medical apparatus within a patient, comprising the steps of:

(a) providing the medical apparatus composing an accessing tool, and a probe operatively connected with the accessing tool and located at the distal end of the accessing tool, wherein the probe comprises at least one pressure transducer;

(b) inserting at least a portion of the accessing tool into the patient;

(c) manipulating the accessing tool until the distal end of the accessing tool is adjacent a body site;

(d) contacting the body site with the probe in a first position, thereby generating a first information signal from the at least one pressure transducer, wherein the first signal conveys the direction of a force applied by the body site on the probe; and

(e) altering the position of the probe based at least in part on the first signal to a second position, thereby generating a second information signal.

2. The method of claim 1, wherein the second position is a desired position of the probe in relation to the body site.

3. The method of claim 1, further comprising the step of altering the positioning of the probe based at least in part on the second signal to a third position, thereby generating a third information signal.

4. The method of claim 1, wherein the information from at least the first signal conveys the incident angle of the probe relative to a surface of the body site.

5. The method of claim 1, wherein the first signal conveys the magnitude of a force applied by the body site on the probe.

6. The method of claim 1, wherein the apparatus further comprises a monitoring device, and wherein the first signal is displayed via the monitoring device.

7. The method of claim 1, wherein the probe further comprises at least one effector configured to provide a therapeutic effect.

8. The method of claim 7, wherein the probe further comprises an activator, and wherein the activator is associated with the effector such that the activation of the activator causes the effector to provide a therapeutic effect.

9. The method of claim 7, wherein the effector is configured to provide a therapeutic effect upon the reaching of a threshold force measured by the at least one pressure transducer.

10. The method of claim 1, wherein the accessing tool is inserted in step (b) using a catheter.

11. The method of claim 1, wherein the manipulation of the accessing tool in step (c) is aided by the use of x-ray fluoroscopy.

12. The method of claim 1, wherein the probe further comprises a support member, and wherein at least one pressure transducer is situated on the support member.

13. The method of claim 1, wherein the accessing tool further comprises a shaft located near the distal end of the accessing tool, and wherein the shaft is movable relative to the accessing tool.

14. The method of claim 13, wherein said pressure transducer includes (i) first and second conductors, (ii) an insulating layer adjacent the first conductor, said layer having one or more perforations therein, and (iii) a conductive elastomer disposed between the insulating layer and the second conductor and in contact with the second conductor, and the insulating layer and the conductive elastomer each (i) is mounted about the shaft, and (ii) at least partially surrounds the shaft.

15. The method of claim 14, wherein the insulating layer and the conductive elastomer each has an opening therein for receiving the shaft;

and the shaft is inserted through the openings in the insulating layer and the conductive elastomer.

16. The method of claim 15, wherein the insulating layer is generally in the shape of a disk;

and the opening in the insulating layer is disposed at or proximate the diametrical center of the insulating layer.

17. The method of claim 15, wherein the conductive elastomer has a generally circular configuration;

and the opening in the conductive elastomer is disposed at or proximate the diametrical center of the conductive elastomer.

18. A method of positioning a medical apparatus within a patient, comprising the steps of:

(a) providing the medical apparatus comprising an accessing tool, and a probe operatively connected with the accessing tool and located at the distal end of the accessing tool, wherein the probe comprises at least one pressure transducer, and at least one effector configured to provide a therapeutic effect upon the reaching of a threshold force measured by the at least one pressure transducer;

(b) inserting at least a portion of the accessing tool into the patient;

(c) manipulating the accessing tool until the distal end of the accessing tool is adjacent a body site;

(d) contacting the body site with the probe in a first position, thereby generating a first information signal from the at least one pressure transducer; and

(e) altering the position of the probe based at least in part on the first signal to a second position, thereby generating a second information signal.

19. The method of claim 18, wherein the information from at least the first signal conveys the incident angle of the probe relative to a surface of the body site.

20. The method of claim 18, wherein the first signal conveys the magnitude of a force applied by the body site on the probe.

21. The method of claim 18, wherein the apparatus further comprises a monitoring device, and wherein the first signal is displayed via the monitoring device.

22. The method of claim 18, wherein the probe further comprises a support member, and wherein at least one pressure transducer is situated on the support member.

23. The method of claim 18, wherein the probe further comprises an activator, and wherein the activator is associated with the effector such that the activation of the activator causes the effector to provide a therapeutic effect.

24. A method of positioning a medical apparatus within a patient, comprising the steps of:

(a) providing the medical apparatus comprising an accessing tool comprising a shaft located near the distal end of the accessing tool and wherein the shaft is movable relative to the accessing tool, and a probe operatively connected with the accessing tool and located at the distal end of the accessing tool, wherein the probe comprises at least one pressure transducer, and wherein said pressure transducer includes (i) first and second conductors, (ii) an insulating layer adjacent the first conductor, said layer having one or more perforations therein, and (iii) a conductive elastomer disposed between the insulating layer and the second conductor and in contact with the second conductor; and

the insulating layer and the conductive elastomer each (i) is mounted about the shaft, and (ii) at least partially surrounds the shaft;

(b) inserting at least a portion of the accessing tool into the patient;

(c) manipulating the accessing tool until the distal end of the accessing tool is adjacent a body site;

(d) contacting the body site with the probe in a first position, thereby generating a first information signal from the at least one pressure transducer; and

(e) altering the position of the probe based at least in part on the first signal to a second position, thereby generating a second information signal.

25. The method of claim 24, wherein the insulating layer and the conductive elastomer each has an opening therein for receiving the shaft;

and the shaft is inserted through the openings in the insulating layer and the conductive elastomer.

26. The method of claim 25, wherein the insulating layer is generally in the shape of a disk;

and the opening in the insulating layer is disposed at or proximate the diametrical center of the insulating layer.

27. The method of claim 25, wherein the conductive elastomer has a generally circular configuration;

and the opening in the conductive elastomer is disposed at or proximate the diametrical center of the conductive elastomer.