Systems and methods for detecting tissue contact and needle penetration depth

• US 8,177,748 B1
• Filed: 06/15/2004
• Issued: 05/15/2012
• Est. Priority Date: 06/10/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Beyerlein, Dagmar
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Gray, Phillip
• Application Number:
  US10/869,691
• Time in Patent Office: 2,891 Days
• Field of Search: 604/8, 604/19, 604/48, 604/93.01, 604/181, 604/185, 604/264, 604/506, 604/528, 604/323, 604115-118, 604/96.01, 604/164.01, 604/523, 604103-107
• US Class Current: 604/117
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• 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 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/4896 Epidural space
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres

Abstract

Systems and methods for determining tissue contact and penetration depth are provided. In one aspect, the system includes a needle and a pressure measurement assembly. The needle, in one exemplary embodiment, includes a first end and a second end with at least one aperture located a predetermined distance from the first end. The pressure measurement assembly is connected with a portion of the needle to measure pressure of fluid flowing through the needle. The pressure measurement assembly measures a first pressure when the needle contacts tissue and a second difference in pressure when the needle penetrates the tissue and the aperture becomes occluded.

Claims

1. A system for detecting needle penetration depth comprising:

a fluid delivery catheter;

a needle sheath attached to the fluid delivery catheter;

a needle, at least a portion of the needle movably positioned within the needle sheath, with a first end and a second end having an opening adapted to deliver a therapeutic agent, the needle coupled with the fluid delivery catheter;

a balloon coupled with the fluid delivery catheter and the needle sheath, the needle sheath positioned along and contacting an outer surface of an expandable wall forming a proximal end of the balloon, the needle sheath having an open terminating end positioned at the outer surface of the expandable wall forming the proximal end of the balloon such that the needle sheath does not contact a portion of the balloon distal to the proximal end and upon inflation of the balloon, the expandable wall of the balloon will expand to contact a region of the needle sheath adjacent the open end and deflect the region of the needle sheath and the needle along the expandable wall of the balloon and direct a tip of the needle toward a tissue to be penetrated such that, once the balloon is inflated, advancement of the needle in a distal direction from the needle sheath will penetrate the tissue; and

a sensor coupled with a portion of the needle to detect a contact pressure of tissue on the sensor as the needle penetrates tissue, the sensor located a predetermined distance from the first end of the needle, wherein the predetermined distance is approximately equal to a desired penetration depth of the needle into the tissue.

2. The system of claim 1 wherein the sensor comprises a strain gauge located a predetermined distance from the first end of the needle.

3. The system of claim 2 further comprising an encapsulant coupled with the strain gauge and needle.

4. The system of claim 1 wherein the sensor comprises a piezoelectric transducer located a predetermined distance from the first end of the needle.

5. The system of claim 4 wherein piezoelectric transducer has a ring shape with an inner diameter larger than an outer diameter of the needle.

6. The system of claim 1 wherein the predetermined distance from the first end is about 0.5 to 10 millimeters.

7. The system of claim 1 wherein the first end of the needle has at east one of a tapered and untapered portion.

8. The system of claim 1 wherein the needle has an outer diameter in the range between about 0.008 and 0.26 inches.

9. The system of claim 1 wherein the needle has an inner diameter in the range between about 0.004 and 0.22 inches.

10. The system of claim 2 wherein the strain gauge has a width in the range between about 0.006 and 0.20 inches.

11. The system of claim 4 wherein the piezoelectric transducer has an inner diameter in the range between about 0.008 and 0.26 inches.

16. The system of claim 1 wherein the balloon is concentrically coupled with the fluid delivery catheter.

18. The system of claim 1 further comprising a guidewire positioned within the fluid delivery catheter.

12. A method to determine penetration depth of a needle used internally to deliver a therapeutic agent to a patient comprising:

delivering a fluid delivery catheter to a treatment site, at least a portion of the needle movably positioned within a sheath of the fluid delivery catheter;

inflating a balloon concentrically attached to a dilation catheter of the fluid delivery catheter, the sheath having an open terminating end positioned at a side of the balloon forming a proximal end of the balloon such that the needle sheath does not contact a portion of the balloon distal to the proximal end and upon inflation, the side of the balloon will deflect the needle and sheath along the side of the balloon and direct a tip of the needle toward a tissue to be penetrated such that, once the balloon is inflated, advancement of the needle in a distal direction from the needle sheath will penetrate the tissue;

inserting the needle into tissue until the tissue contacts a sensor located a predetermined distance from a first end of the needle, wherein the predetermined distance is approximately equal to a desired penetration depth of the needle into the tissue; and

sensing a contact pressure of the tissue on the sensor to determine penetration depth of the needle; and

delivering the therapeutic agent through the needle when the needle is at the desired penetration depth.

13. The method of claim 12 wherein the predetermined distance from the first end is about 0.5 to 10 millimeters.

14. The method of claim 12 wherein the sensor comprises a strain gauge.

15. The method of claim 12 wherein the sensor comprises a piezoelectric transducer.

17. The method of claim 12 wherein an entire circumference of a wall forming a portion of the balloon circumferentially outward from the dilation catheter is expandable around the dilation catheter and upon inflation of the balloon, an outer surface of the wall will deflect the needle and sheath along the wall.

19. A system for detecting needle penetration depth comprising:

a fluid delivery catheter;

a needle sheath attached to the fluid delivery catheter;

a needle, at least a portion of the needle movably positioned within the needle sheath, with and a second end having opening adapted to deliver a therapeutic agent, the needle coupled with the fluid delivery catheter;

a balloon coupled with the fluid delivery catheter sheath, the needle sheath positioned along and contacting an outer surface of an expandable wall forming a proximal end of the balloon, the needle sheath having an open end positioned at and not extending beyond a proximal portion of the balloon such that the needle sheath does not contact a distal portion of the balloon and upon inflation of the balloon, the expandable wall of the balloon will expand to contact a region of the needle sheath adjacent the open end and deflect the region of the needle sheath and the needle along the expandable all of the balloon and direct a tip of the needle toward a tissue to the penetrated such that, once the balloon is inflated, advancement of the needle in a distal direction from the needle sheath will penetrate the tissue; and

a sensor coupled with a portion of the needle to detect a contact pressure of tissue on the sensor as the needle penetrates tissue, the sensor located a predetermined distance from the first end of the needle, wherein the predetermined distance is approximately equal to a desired penetration depth of the needle into the tissue.

20. A method to determine penetration depth of a needle used internally to deliver a therapeutic agent to a patient comprising:

delivering a fluid delivery catheter to a treatment site, at least a portion of the needle movably positioned within a sheath of the fluid delivery catheter;

inflating a balloon concentrically attached to a dilation catheter of the fluid delivery catheter, the sheath having an open end positioned at and not extending beyond a proximal portion of the balloon such that the needle sheath does not contact a distal portion of the balloon and upon inflation, will deflect the needle and sheath along a side of the balloon and direct a tip of the needle toward a tissue to be penetrated such that, once the balloon is inflated, advancement of the needle in a distal direction from the needle sheath will penetrate the tissue;

inserting the needle into tissue until the tissue contacts a sensor located a predetermined distance from a first end of the needle, wherein the predetermined distance is approximately equal to a desired penetration depth of the needle into the tissue; and

sensing a contact pressure of the tissue sensor to determine penetration depth of the needle; and

delivering the therapeutic agent through the needle when the needle is at the desired penetration depth.