Systems and methods for detecting tissue contact and needle penetration depth using static fluid pressure measurements

• US 8,574,195 B2
• Filed: 09/05/2003
• Issued: 11/05/2013
• Est. Priority Date: 06/10/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Beyerlein, Dagmar
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US10/656,491
• Publication Number:
  US 20040260240A1
• Time in Patent Office: 3,714 Days
• Field of Search: 604/117, 604/118, 604/505, 604/246, 604/264, 604/275, 604/121, 604/187, 604/272, 604/274, 600/300
• US Class Current: 604/118
• 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 5/489 Blood vessels
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

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 fluid pressure measurement assembly is connected with a portion of the needle to measure pressure of fluid dispensed in the needle. The fluid pressure measurement assembly measures a first pressure of the fluid, a second pressure when the needle contacts tissue and a third pressure when the needle penetrates the tissue and the aperture becomes occluded.

Claims

1. A system for detecting tissue contact and penetration depth comprising:

a needle with a first opening to and in fluid communication with a lumen of the needle and a second opening to and in fluid communication with the same lumen of the needle, said needle having the lumen extending between the first opening and the second opening, and the second opening including at least one aperture in the needle to the lumen located a predetermined distance from said first opening;

a fluid pressure measurement assembly coupled with a portion of said needle to measure pressure of a fluid dispensed in said needle, said pressure measurement assembly configured to measure no significant change in pressure as compared to a first pressure that is the pressure of said fluid as said fluid is dispensed through said needle at a constant rate, a second pressure that is a significant increase in pressure as compared to the first pressure when said needle contacts said tissue and said first opening becomes occluded, and a third pressure that is a significant increase in pressure as compared to the second pressure when said needle penetrates said tissue and said aperture becomes occluded.

2. The system of claim 1 wherein said pressure measurement assembly comprises:

a fluid pressure sensor.

3. The system of claim 1 wherein said pressure of fluid includes a pressure of a therapeutic agent to be injected into said tissue.

4. The system of claim 1 wherein said aperture has an area in said range between about 0.003 and 10 mm².

5. The system of claim 4 wherein said predetermined distance from said first end is about 0.5 to 10 millimeters.

6. The system of claim 1 wherein said predetermined distance is a desired penetration depth of said needle into said tissue.

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

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

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

10. The system of claim 1 further comprises a computer processor coupling to said fluid pressure measurement assembly, said computer processor configured to perform at least one of determining and distinguishing said rate of changes in said static pressure to determine and distinguish said various penetration depths of said needle.

11. The system of claim 10 wherein said computer processor further couples to at least one of a visual feedback system indicator and an audible feedback system to issue human-recognizable signals as to penetration depths of said needle.

12. The system of claim 1 further comprising a signal processor or a computer processor coupled to the fluid pressure measurement assembly to differentiate the third pressure from the first pressure and from the second pressure by detecting the second pressure change when said needle penetrates said tissue said predetermined distance and said aperture becomes occluded.

13. The system of claim 1 further comprising a circuit to differentiate between:

(1) a first pressure indicating that the needle has not reached the tissue;

(2) a second pressure indicating that the needle has penetrated the tissue and the first opening has become occluded based on a change in pressure or a rate of change in pressure to a significantly larger magnitude; and

(3) a third pressure indicating that the needle has penetrated the tissue by the predetermined distance and that the aperture is occluded based on a change in pressure or a rate of change in pressure to a significantly larger magnitude.

14. The system of claim 13 further comprising:

a visual indicator or an audible feedback system to indicate that the needle has not reached the tissue when the first pressure is measured;

to indicate that the needle has penetrated the tissue and the first opening has become occluded when the second pressure is measured; and

to indicate that the needle has penetrated the tissue by the predetermined distance when the third pressure is measured.

15. The system of claim 13 wherein the first opening is in a tip of the needle.

16. The system of claim 1 further comprising a visual indicator or an audio feedback system that indicates to an operator:

(1) to advance the needle in response to the fluid pressure measurement assembly measuring no significant change in pressure as compared to the first pressure, (2) to proceed with the advancement of the needle slowly in response to the fluid pressure measurement assembly measuring the significant increase in pressure as compared to the first pressure, and (3) to stop the advancement of the needle because the penetration depth desired has been achieved in response to the fluid pressure measurement assembly measuring the significant increase in pressure as compared to the second pressure.