WO2020206244A1

WO2020206244A1 - Systems and methods for advancing a catheter to a target site

Info

Publication number: WO2020206244A1
Application number: PCT/US2020/026566
Authority: WO
Inventors: Michael N. SINGLETON
Original assignee: Vanderbilt University
Priority date: 2019-04-05
Filing date: 2020-04-03
Publication date: 2020-10-08

Abstract

Catheter advancement systems and methods are provided. Such systems and methods can be used by a single user to manipulate and control multiple medical devices in one hand and manipulate at least one other medical device in another hand.

Description

SYSTEMS AND METHODS FOR ADVANCING A CATHETER TO A TARGET SITE

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 62/829,742, filed April 5, 2019, entitled SYSTEMS AND METHODS FOR ADVANCING A CATHETER TO A TARGET SITE.” This provisional application is hereby incorporated by reference in its entirety for all purposes.

TECHNICAL FIELD

A catheter positioning system for providing a peripheral nerve block is provided. BACKGROUND

Regional anesthesia has had a surge in popularity over the last decade. It has the capacity to improve pain management and patient satisfaction, reduce opioid use and adverse events, and provide cost savings through shorter hospital stays. The simplest approach for delivering regional anesthesia is through single injection nerve blocks, however their benefits are limited by a relatively short duration. Methods of prolonging the duration of single injections include the addition of medications to extend their effects or through special extended release formulations of local anesthetics, however these are not without their drawbacks. It is difficult to prolong the effects of a single injection more than a day without using an expensive extended release local anesthetic. When the effects of these nerve blocks diminish, patients have to transition to systemic pain medications which have traditionally been based on opioids. One solution to this issue is the placement of peripheral nerve catheters which may remain in situ for several days. They provide a source of local anesthetic for the duration they remain in place, extending the analgesic benefit of nerve blocks far beyond what is otherwise possible.

Peripheral nerve catheters, however, are not without their challenges. Accurate placement and thus effectiveness depends greatly upon the skill of the individual placing the catheter and their ability to determine whether the tip of the catheter rests near its intended target. To effectively accomplish this, a clinician generally visualizes the placement of the catheter in real time under ultrasound. This presents a challenge in that it requires the clinician to have control of the ultrasound probe, the needle, and the catheter simultaneously. Most practitioners resort to having an assistant don sterile gloves to assist in the procedure either by advancing the catheter or by holding the ultrasound probe, which can be a challenge for someone unskilled in the field of nerve blocks. Otherwise, a solo practitioner could thread the catheter blindly, which may risk sub-optimal placement.

SUMMARY

Systems and methods for advancing a medical device, such as a catheter, to a target site in a patient are provided. In an aspect, an exemplary catheter positioning system can include a needle comprising a proximal end with a connection fitting, a distal end, and a needle lumen extending longitudinally between the proximal end and the distal end. The catheter positioning system can also include a catheter comprising a catheter body having a catheter lumen selectively co-axial with the needle lumen. The catheter positioning system can further include a delivery instrument comprising a shaft and a handle depending from the shaft. The shaft can comprise a proximal end, a distal end with a connection fitting complimentary to the connection fitting of the needle, and a shaft lumen extending between the proximal end and the distal end and selectively co-axial with the catheter lumen. The shaft and the handle can collectively define an opening to accommodate at least part of a single user’s hand.

In another aspect, a method of delivery therapy to a patient by a single user is provided

A method can include obtaining a delivery instalment comprising a shaft having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and selectively co-axial with the lumen of a needle. The delivery instrument can also include a handle depending from the shaft. The shaft and handle can collectively define an opening to

accommodate at least part of the single user’s hand. The method can further comprise attaching a needle have a lumen to the distal end of the delivery instrument and inserting a catheter through the lumen of the needle. The method can further include urging the handle of the delivery' instrument to advance the catheter to a target site of the patient’s body using one hand of the single user. The method can also include positioning and moving a hand-held medical device on or in the patient’s body using the other hand of the single user. Once the proper target site has been reached, the method includes delivering a therapeutic agent through the catheter to the target site of the patient’s body. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a catheter positioning system according to an aspect of the present disclosure.

FIG. 2 is a perspective view of a catheter positioning system according to an aspect of the present disclosure.

FIG. 3 is a side view of a catheter positioning system according to an aspect of the present disclosure.

FIG. 4 is a side view of a catheter positioning system depicting a single user’s hand positioned on the delivery tool.

FIG. 5 is a flow chart depicting exemplary steps for a method of delivering therapy to a patient by a single user.

DETAILED DESCRIPTION

As used herein with respect to a described element, the terms“a,”“an,” and“the” include at least one or more of the described element including combinations thereof unless otherwise indicated. Further, the terms“or” and“and” refer to“and/or” and combinations thereof unless otherwise indicated. It will be understood that when an element is referred to as being“over,” “on,”“attached” to,“connected” to,“coupled” with,“contacting,”“in communication with,” etc., another element, it can be directly over, on, attached to, connected to, coupled with, contacting, or in communication with the other element or intervening elements may also be present. In contrast, when an element is referred to as being“directly over,”“directly on,” “directly attached” to,“directly connected” to,“directly coupled” with,“directly contacting,” or in“direct communication” with another element, there are no intervening elements present. An element that is disposed“adjacent” another element may have portions that overlap or underlie the adjacent element. By“substantially” is meant that the shape, configuration, or orientation of the element need not have the mathematically exact described shape, configuration or orientation but can have a shape, configuration or orientation that is recognizable by one skilled in the art as generally or approximately having the described shape, configuration, or orientation. The catheter positioning systems are used for medical purposes and therefore its components are sterile. As used herein, a“patient” includes a mammal such as a human being. A“user,” as used herein, is a human user. Systems and methods for advancing a medical device, such as a catheter, to a target site are provided. Uses include, but are not limited to placement of peripheral nerve catheters, placement of intravascular wires or catheters such as, for example, placement of a wire to then guide a central venous catheter or other arterial and venous catheters via the Seldinger technique, placement of indwelling electrical leads or wires, or any other application of indwelling wires, catheters, stimulators, medication delivery devices, or leads. Such systems and methods can be used by a single user, such as a clinician, to manipulate and control multiple medical devices in one hand and manipulate at least one other medical device in another hand. For example, systems and methods can be used for peripheral nerve catheter placement, allowing a single user to control the needle, catheter and ultrasound probe simultaneously, helping ensure accurate placement and optimal effectiveness for the entirety of the catheter's duration in situ. Allowing one individual to control all three components can negate the need to have a second individual help with the procedure with sterile precautions. It also more easily allows real time

advancement of the catheter under ultrasound visualization to assure proper placement and effectiveness for the patient.

Referring to FIGs. 1-4, an exemplary catheter positioning system 10 can include needle 12 comprising proximal end 14 with connection fitting 16, distal end 18, and a needle lumen extending longitudinally between proximal end 14 and distal end 18 Catheter positioning system 12 can also include catheter 20 comprising catheter body 22 having a catheter lumen selectively co-axial with the needle lumen. Catheter positioning system 10 can further include delivery instrument 24 comprising shaft 26 and handle 36 depending from shaft 26. Shaft 26 can comprise proximal end 28, distal end 30 with connection fitting 32 complimentary to connection fitting 16 of needle 12, and a shaft lumen 34 ex tending between proximal end 28 and distal end 30 and selectively co-axial with the catheter lumen. Connection fitting 32 can be, for example, a male Luer lock connection fitting and connection fitting 16 can be a female Luer-lock fitting, or vice versa. Handle 36 can have one end 42 connected to first portion 44 of bottom surface 50 of shaft 26 and another end 46 connected to second portion 48 of bottom surface 50 of shaft 26 as illustrated in FIG. 3. Shaft 26 and handle 36 can collectively define opening 38 to accommodate at least part of a single user’s hand 40. In certain aspects, as shown in FIG. 4, opening 38 has a semi-circular shape. The opening can have any suitable shape and size so long as the opening can accommodate at least part a single user's hand, such as the user’s fingers as illustrated in FIG. 4.

Methods of delivering therapy to a patient using a catheter positioning system are also provided. Referring to FIG. 5, such a method 100 can involve obtaining a delivery instrument comprising a shaft and a handle as described above 102 Method 100 can further comprise attaching a needle having a lumen to the distal end of the delivery instrument 104 and inserting a catheter through the needle lumen 106. Method 100 can further include urging the handle of the delivery instrument to advance the catheter to a target site of the patient’s body using one hand of the single user 108. Method 100 additionally includes positioning and manipulating another hand-held medical device on or in the patient’s body using the other hand of the single user 110. Method 100 can then include delivering a therapeutic agent through the catheter to the target site of the patient’s body 112. Such a method can be used, for example, to place a catheter adjacent a peripheral nerve to perform a nerve block. In such an instance, the hand-held medical device can be an ultrasound probe, the therapeutic agent can be an anesthetic, the target site can be a peripheral nerve, and delivering therapy can comprise delivering an anesthetic to the peripheral nerve of the patient’s body to achieve a nerve block in particular, in an exemplary' method, a single clinician can attach a needle to the delivery_' instrument and insert the needle into the patient’s skin. The needle can be guided to the targeted nerve using ultrasound imaging via an ultrasound probe placed on the patient’s body. Proper needle placement can be verified using a bolus injection of a solution or via nerve stimulation. Once it has been confirmed that the needle is in the proper location, a catheter can be guided via the delivery instrument through the needle to the targeted nerve tissue. Then the needle can be removed, leaving the catheter in place. The other end of the catheter then can be connected to a small container containing the analgesic agent. This allows the catheter to provide a continuous flow of medication to the area.

Such a method and system allows a clinician to use one hand to both control the peripheral nerve block needle and advance the catheter through the needle into the desired location next to the nerve. This allows the clinician’s other hand to be free to manipulate ultrasound for improved needle visualization. A delivery instrument as provided herein, in the context of regional anesthesia, for example, combines the ability to lock onto a needle to give control while providing a platform for easy advancement of a catheter through the needle. Peripheral nerve catheter placement is just one example of how systems and methods as disclosed herein can be employed. Systems and methods can be used in other medical procedures where it is advantageous for a single user to manipulate and control multiple medical devices in one hand and manipulate and control at least one other hand-held medical device in the other hand.

Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the disclosure. Unless otherwise specified, none of the steps of the methods of the present disclosure are confined to any particular order of performance.

Claims

What is claimed is:

1. A catheter positioning system comprising:

a needle comprising a proximal end with a connection fitting, a distal end, and a needle lumen extending longitudinally between the proximal end and the distal end;

a catheter comprising a catheter body having a catheter lumen selectively co-axial with the needle lumen;

a delivery instrument comprising:

a shaft comprising a proximal end, a distal end with a connection fitting complimentary to the connection fitting of the needle, and a shaft lumen extending between the proximal end and the distal end and selectively co-axial with the catheter lumen;

a handle depending from the shaft, the shaft and handle collectively defining an opening to accommodate at least part of a single user’s hand.

2. The catheter positioning system of claim 1, wherein the handle comprises one end connected to a first portion of the shaft and another end connected to a second portion of the shaft.

3. The catheter positioning system of claim 1, wherein the first and second portions are on a bottom surface of the shaft.

4. The catheter positioning system of claim 1, wherein the handle has a substantially semi circular shape.

5. A method of delivery therapy to a patient by a single user comprising:

obtaining a delivery instrument comprising:

a shaft comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and selectively co-axial with the lumen of a needle. a handle depending from the shaft, the shaft and handle collectively defining an opening to accommodate at least part of the single user’s hand;

attaching a needle have a lumen to the distal end of the delivery instalment, inserting a catheter through the lumen of the needle;

urging the handle of the delivery instrument to advance the needle and the catheter to a target site of the patient’s body using one hand of the single user;

positioning and moving a hand-held medical device in or on the patient’s body using the other hand of the single user;

delivering a therapeutic agent through the catheter to the target site of the patient’s body.

6. The method of claim 1, wherein the hand-held medical device is an ultrasound probe.

7. The method of claim 5, wherein the therapeutic agent is an anesthetic, the target site is nerve, and delivering therapy comprises delivering an anesthetic to the nerve of the patient’s body to achieve a nerve block.

8 The method of claim 7, wherein the nerve is a peripheral nerve.