Device and method for identification of a target region

Abstract

A method and apparatus are provided for use in locating a target region which is situated in the body of a subject, for example for the delivery of drugs. The system includes an assembly for controlling the flow of fluid from a fluid reservoir to a conduit, such as a needle. A sensor detects a characteristic indicative of the fluid pressure in the conduit. The system processes data from the sensor to detect the presence of a pulsatile waveform. A controller may control further operation of the system based on information regarding the presence of the pulsatile waveform and features of the waveform, such as amplitude.

Description

RELATED APPLICATIONS[0001]This application is a continuation of International Application No. PCT / US20 / 22910, filed Mar. 16, 2020, which claims the benefit of priority of U.S. application Ser. No. 16 / 414,499, filed on May 16, 2019, now U.S. Pat. No. 10,646,660 issued May 12, 2020, the entire contents of which application(s) are incorporated herein by reference.TECHNICAL FIELD[0002]The present invention relates generally to methods and apparatus for use in locating a target region which is situated in a body of a subject, for example for the delivery of drugs.BACKGROUND[0003]Locating a target region in a body, for example an anatomical cavity in a body of a patient, is important, inter alia, for anesthetics, or biopsy or aspiration of material from the cavity.[0004]For example, a regional anesthesia block of the epidural tissue-space is understood to produce effective transient anesthesia of the lower extremities of the body. It can be effectively used for a vast number of invasive p...

AI Technical Summary

Benefits of technology

[0011]The present invention provides a method and apparatus or device that enables practitioners to more easily perform the identification of anatomical target regions such as the epidural space.

[0012]The present invention provides a novel system for guiding a needle to an anatomical target region. The system provides a software logic and apparatus that can simplify discrimination between a false-LOR and true-LOR when performing these operations, such as detection of the epidural space, thereby improving the reliability and safety of such injections.

[0013]According to a first aspect, the present invention provides a needle bearing apparatus for administering fluid into an anatomic space of a mammalian subject. The apparatus includes a fluid reservoir for storing fluid to be provided to the needle, an ejection element displaceable relative to the fluid reservoir to expel fluid from the reservoir and a drive element configured to engage the ejection element to control displacement of the ejection element. A controller is provided for controlling the drive element to control the flow of fluid from the reservoir to the needle. Additionally, the apparatus includes a sensor for detecting a characteristic indicative of the fluid pressure in the needle. The sensor is configured to continuously detect the characteristic as the needle-bearing apparatus is inserted into the subject. A flexible conduit is in fluid communication with the fluid reservoir and the sensor; and the conduit is substantially rigid radially. The controller periodically discontinues movement of the drive element and processes data from the sensor to detect one or more characteristics indicative of a pulsatile waveform. Additionally, the conduit, reservoir, ejection element and drive element are configured so that the fluid volume between the needle and the fluid reservoir is substantially constant so that the sensor is able to accurately detect the pulsatile waveform passing through residual fluid in the needle when movement of the drive element is discontinued. Optionally, the fluid reservoir may be a syringe barrel. Additionally, the ejection element may be slidably displaceable within the fluid reservoir.

Problems solved by technology

Any backward movement (retraction) of the needle along a path during the repositioning creates a drop in pressure in the fluid, which can result in a false-LOR further complicating the detection of a true-LOR.

False-LORs can lead to many problems.

The additional fluid released into these tissues can further complicate the identification of epidural space.

Additionally, if the doctor has difficulty discriminating between a false-LOR and a true-LOR, the Touhy needle may be moved beyond the boundary of the epidural space and inadvertently advanced into and through the dura of the spinal cord producing what is termed a wet-tap, which can have dangerous long-term consequences to the patient.

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