ASSEMBLIES AND METHODS

• US 20130150712A1
• Filed: 02/06/2013
• Published: 06/13/2013
• Est. Priority Date: 11/15/2007
• Status: Abandoned Application

• Current Assignee: Smiths Medical International Limited (ICU Medical Incorporated)
• Original Assignee: Smiths Medical International Limited (ICU Medical Incorporated)
• Inventors: Field, Stephen James
• Application Number:
  US13/760,406
• Publication Number:
  US 20130150712A1
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A needle assembly comprises a metal needle (1) with a hub (13) and a marker in the form of a bubble-filled plastics rod (2) inserted within the needle. The rod (2) makes the assembly more visible under ultrasound observation when confirming correct placement of the needle (1) and is subsequently removed when correct placement has been confirmed. A fluid (3) is placed between the outside of the rod (2) and the inside of the needle (1) to improve acoustic coupling between the needle and the rod. Alternatively, a rod (72) is stretched during insertion and allowed to expand into close contact with the inside of the needle after insertion.

Claims

1. A needle assembly including a hollow metal needle, wherein the assembly includes a plastics rod removably mounted within the needle along its length and containing a plurality of gas bubbles within the thickness of the rod along its length such that the rod is visible under ultrasound observation and such that the ultrasound visibility of the assembly with the rod is greater that that of the needle alone.

2. An assembly according to claim 1, wherein the gas bubbles extend along substantially the entire length of the rod.

3. An assembly according to claim 1, wherein the gas bubbles have a size between 0.1μ

and 300μ

.

4. An assembly according to claim 3, wherein the gas bubbles have a size between approximately 5μ

and 10μ

.

5. An assembly according to claim 1, wherein the assembly includes a flowable substance between the outside of the rod and the inside of the needle to provide acoustic coupling between the rod and needle so that during acoustic scanning acoustic energy passes through the needle to the rod.

6. An assembly according to claim 5, wherein the flowable substance is a body fluid.

7. An assembly according to claim 5, wherein the flowable substance is a liquid or gel applied to the outside of the rod.

8. A method of enhancing visibility of a catheter or needle under ultrasound observation comprising the steps of:

inserting the catheter or needle into a medium containing a liquid and subsequently sliding a bubble-filled stylet backwards and forwards within the catheter or needle so as to draw liquid from the medium into the bore of the catheter or needle and to distribute the liquid between the outside of the stylet and the inside of the needle or catheter such that the liquid forms a layer between the stylet and the needle that provides enhanced acoustic coupling between the stylet and the needle or catheter.

9. A method of enhancing visibility of a catheter or needle under ultrasound observation comprising the steps of:

inserting the catheter or needle into the body and subsequently sliding a bubble-filled stylet backwards and forwards within the catheter or needle so as to draw body fluid from the body into the bore of the catheter or needle and to distribute the fluid between the outside of the stylet and the inside of the needle or catheter such that the body fluid forms a layer of liquid between the stylet and the needle that provides enhanced acoustic coupling between the stylet and the needle or catheter.

10. A method of enhancing the visibility of a catheter or needle under ultrasound observation comprising the steps of:

applying a coating to the outside of a stylet of a bubble-filled plastics material, the coating being of a flowable material, inserting the stylet into the bore of a catheter or needle so that the flowable material forms a layer between the stylet and the catheter or needle that provides enhanced acoustic coupling between the stylet and the catheter or needle.

11. An assembly including an outer tubular component, an inner component of a stretchable material containing a plurality of gas bubbles within its thickness, the inner component having a natural external diameter greater than the internal diameter of the outer component so that the inner component is in compression within the outer component to provide acoustic coupling between the outer and inner components and so that during acoustic scanning acoustic energy passes through the outer component to the inner component, the bubbles in the inner component being selected to increase the amount of acoustic energy reflected by the inner component and hence by the assembly.

12. An assembly according to claim 11, wherein the inner component has a bore extending along its length that is closed towards its forward end, and wherein the assembly includes an extension rod insertable within the bore of the inner component to stretch the inner component and reduce its external diameter during insertion within the outer component.

13. A method of enhancing visibility of a catheter or needle under ultrasound observation comprising the steps of:

providing a stylet having a bore extending along its length that is closed at its forward end, the stylet being of a stretchable material containing gas bubbles, inserting an extension rod into the bore of the stylet to stretch it longitudinally and reduce its external diameter from a first diameter greater than the internal diameter of the catheter or needle to a second diameter less than the internal diameter of the catheter or needle, inserting the stretched stylet into the bore of the catheter or needle to a desired position, withdrawing the extension rod and allowing the stylet to expand radially into close contact and acoustic coupling with the inside of the catheter or needle.