Systems and methods for detecting tissue contact and needle penetration depth

• US 7,364,567 B2
• Filed: 06/10/2002
• Issued: 04/29/2008
• Est. Priority Date: 06/10/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Beyerlein, Dagmar
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US10/166,854
• Publication Number:
  US 20050004513A1
• Time in Patent Office: 2,150 Days
• Field of Search: 604116-118, 604/131, 604/264, 604/272, 604/505, 604/246, 604/275, 604/66, 600/104, 600/117, 600/202, 600/424, 600485-488, 600/550, 600/561, 606/167, 606/170, 606/172
• 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.

In an alternative aspect, the system includes a needle and a sensor. The sensor, in another exemplary embodiment, is coupled with a portion of the needle to detect tissue contact pressure on the sensor as the needle penetrates tissue and makes contact with the sensor. The sensor is located a predetermined distance from the first end of the needle.

Claims

1. A method of detecting tissue contact and a needle penetration depth of a needle used internally to deliver a therapeutic agent to a patient comprising:

dispensing a measured amount of therapeutic agent through a lumen of a needle and from a second end of the needle to a first end of the needle at a predetermined flow rate, wherein the second end of the needle is connected to a pressure measurement assembly;

measuring a pressure of the therapeutic agent in the needle wherein measuring the pressure includes;

measuring a first change in pressure by measuring a change in the flow rate of the therapeutic agent dispensed through the lumen of the needle when the first end of the needle contacts a tissue and the first end of the needle becomes occluded; and

measuring a second change in pressure when the needle penetrates the tissue further and when a first aperture located a predetermined distance from the first end of the needle becomes occluded by measuring another change in the flow rate of the therapeutic agent dispensed through the lumen of the needle, wherein said predetermined distance is used to specify a depth of the needle.

2. The method of claim 1 wherein measuring pressure of the therapeutic agent in the needle includes measuring pressure of the therapeutic agent using a pressure measurement assembly.

3. The method of claim 1 wherein the therapeutic agent is one of a drug, growth factor, and gene therapy.

4. The method of claim 1 wherein the predetermined depth ranges between 0.5 and 10 millimeters.