Pressure sensor for therapeutic delivery device and method

• US 6,695,808 B2
• Filed: 01/17/2003
• Issued: 02/24/2004
• Est. Priority Date: 03/23/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Tom, Curtis P.
• Primary Examiner(s): Ganey, Steven J.
• Application Number:
  US10/347,567
• Publication Number:
  US 20030130615A1
• Time in Patent Office: 403 Days
• Field of Search: 604/65, 604/66, 604/67, 607/120, 607/122
• 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. An apparatus for treating a region of patient tissue, wherein the region has a surface, said apparatus comprising:

(a) an accessing tool for accessing the region, said accessing tool having a distal end and a proximal end at which the accessing tool can be manipulated to place the distal end adjacent to the region;

(b) a probe carried on said distal end and defining a contact surface that may be urged against said surface of the region thereby creating contact pressure;

(c) a pressure transducer operatively coupled to said probe and capable of producing a measurable response to the contact pressure;

(d) a monitoring device operatively connected to said pressure transducer, for determining the contact pressure;

(e) an effector operatively disposed on said probe for producing a given effect on the region when said effector is activated;

(f) an activator operatively connected to said effector, by which said effector can be activated; and

(g) a shaft disposed proximate the distal end of the accessing tool;

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.

2. The apparatus of claim 1, 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.

3. The apparatus of claim 2, 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.

4. The apparatus of claim 2, 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.

5. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

a plurality of pressure transducer elements coupled to the support member or to the cap member at one or more locations at least partially surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals; and

the one or more information signals are indicative of the incident angle of the cap with respect to the surface.

6. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

a plurality of pressure transducer elements coupled to the support member or to the cap member at one or more locations at least partially surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals; and

the one or more information signals are indicative of the direction of the force applied to the cap member by the region.

7. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

a plurality of pressure transducer elements coupled to the support member or to the cap member at one or more locations at least partially surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals; and

the one or more information signals are indicative of the orientation of the cap member with respect to the distal end of the accessing tool.

8. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

a plurality of pressure transducer elements coupled to the support member or to the cap member at one or more locations at least partially surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals;

the opening is centrally positioned on the support member; and

the pressure transducer elements are disposed about the support member at least partially surrounding the opening.

9. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

a plurality of pressure transducer elements coupled to the support member or to the cap member at one or more locations at least partially surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals;

the pressure transducer elements lie generally in a plane; and

the shaft is disposed at a generally normal angle with respect to the plane.

10. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

one or more pressure transducer elements coupled to the support member or to the cap member at one or more locations surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals;

the shaft has a longitudinal axis; and

the distal end of the cap member is movable in a direction lateral to the longitudinal axis.

11. The apparatus of claim 10, wherein the shaft is formed from a resilient material.

12. The apparatus of claim 10, wherein, during operation of the accessing tool, the cap member is movable, in response to a force applied by the region, to an angled orientation with respect to the longitudinal axis.

13. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

one or more pressure transducer elements coupled to the support member or to the cap member at one or more locations surrounding the shaft;

wherein;

during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals; and

at least one of said one or more pressure transducer elements 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.

14. An apparatus for treating a region of patient tissue, wherein the tissue has a surface, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a shaft disposed proximate the distal end of the accessing tool;

a cap member coupled to the shaft and disposed at the distal end of the accessing tool;

a support member having an opening therein for receiving the shaft therethrough, the shaft extending through the opening, and the support member being capable of being positioned near or in contact with a proximal-facing side of the cap member; and

one or more pressure transducer elements coupled to the support member or to the cap member at one or more locations surrounding the shaft;

wherein, during operation of the accessing tool, at least one of the one or more pressure transducer elements, in response to a force applied to the cap member by the region, generates one or more information signals and at least one of said one or more pressure transducer elements includes (i) a primary layer of material having a primary surface, (ii) a first conductive ink layer disposed on the primary surface, (iii) a first semiconductive ink layer disposed on the first conductive ink layer, (iv) a secondary layer of material having a secondary surface, (v) a second conductive ink layer disposed on the secondary surface, and (vi) a second semiconductive ink layer disposed on the second conductive ink layer and separated from the first semiconductive ink layer by an air gap.

15. An apparatus for treating a region of patient tissue, the apparatus comprising:

an accessing tool for accessing the region, the accessing tool having a distal end and a proximal end and being manipulable from the proximal end to place the distal end in contact with the region;

a tool shaft extending along the length of the accessing tool;

a probe contact member coupled to the tool shaft at the distal end of the accessing tool for contacting the region; and

a plurality of sensing shafts running parallel or coherently along the length of the accessing tool from the distal end of the accessing tool to the proximal end of the accessing tool, the sensing shafts having distal and proximal ends, the distal ends of the sensing shafts being in operative communication with the contact member, the proximal ends of the sensing shafts being in operative communication with the distal ends of the sensing shafts and being responsive to movement of the contact member with respect to the tool shaft;

wherein during operation of the accessing tool, the orientation of the proximal ends of the sensing shafts indicates the orientation of the contact member with respect to the tool shaft.

16. The apparatus of claim 15, further comprising a resilient support member coupled to the probe contact member, the resilient support member being operational to bias the contact member toward a predetermined at-rest orientation with respect to the tool shaft.