Visualization of a catheter viewed under ultrasound imaging

• US 8,430,863 B2
• Filed: 01/20/2009
• Issued: 04/30/2013
• Est. Priority Date: 12/02/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Webler, William E.
• Primary Examiner(s): Jung, Unsu
• Assistant Examiner(s): Selkin, Saurel J
• Application Number:
  US12/356,159
• Publication Number:
  US 20090131910A1
• Time in Patent Office: 1,561 Days
• Field of Search: 264/241, 264/248, 264/250, 264/319, 264/327, 295/94
• US Class Current: 604/523
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: Y10T 29/49005 Acoustic transducer

Abstract

A catheter for use in a patient'"'"'s body lumen, having a shaft section configured to minimize ultrasonic image artifacts and the direct ultrasonic image brightness of the shaft surface and its internal components, and to produce its image at a wide range of imaging angles, preferably with an intensity not substantially different than surrounding tissue of the body lumen under ultrasound visualization. The shaft section is operative for the desired use of the catheter, yet is also configured to facilitate accurately imaging the shape and location of the shaft section, and easily differentiate it from the surrounding anatomy without unduly obscuring the images of the adjacent anatomy using an ultrasound imaging system.

Claims

1. A method of making a catheter for use in a patient'"'"'s body lumen, configured for being viewed under ultrasonic imaging using an ultrasound imaging system outside of the patient'"'"'s body lumen, comprising:

a) applying an echo diffusive and dampening polymeric inner and outer layer, with an echogenic member therebetween, on an outer surface of the shaft section; and

b) applying heat and radially inward pressure on an outer surface of the outer layer to heat the inner and outer layers to a first elevated temperature along a second longitudinal portion of the shaft section such that the inner and outer layers fully encapsulate the echogenic member along the second portion, and to a second elevated temperature less than the first elevated temperature along a first longitudinal portion of the shaft section so that an outer surface of the echogenic member is in part separated from adjacent surrounding surfaces of the inner and outer layers by a gap such that the echogenic member is not fully encapsulated along the first portion, and the first portion forms a continuous shaft image and the second portion forms a discontinuous shaft image on a 3D ultrasound image format.

2. The method of claim 1 wherein the first elevated temperature is sufficient to melt and fuse the inner and outer layers together along the second portion, and the second elevated temperature is sufficiently low that the inner and outer layers are not melted and fused together along the first portion.

3. The method of claim 1 wherein b) includes placing a first heat shrink sheath over the outer layer along the first and second portions and a second shorter heat shrink sheath on an outer surface of the first heat shrink sheath along the first portion, such that the first portion is shielded from the applied heat more than the first portion.

4. A method of making a catheter for use in a patient'"'"'s body lumen, configured for being viewed under ultrasonic imaging using an ultrasound imaging system outside of the patient'"'"'s body lumen, comprising:

a) applying an echo diffusive and dampening polymeric inner layer and outer layer, with an echogenic member therebetween, on an outer surface of the shaft section; and

b) applying heat and radially inward pressure on an outer surface of the outer layer to heat the inner and outer layers to fully encapsulate the echogenic member and form a discontinuous shaft image on a 3D ultrasound image format.

5. The catheter of claim 4 wherein the outer layer has metallic or glass echogenic particles, and the inner layer consists essentially of polymeric material.

6. The catheter of claim 5 wherein the outer layer has tungsten particles at a percent loading of 10% to 35%.

7. The catheter of claim 4 wherein the outer layer is formed at least in part of a different polymeric material than the inner layer.

8. A method of making a catheter for use in a patient'"'"'s body lumen, configured for being viewed under ultrasonic imaging using an ultrasound imaging system outside of the patient'"'"'s body lumen, comprising:

a) applying an echo diffusive and dampening polymeric inner layer and outer layer, with an echogenic member therebetween, on an outer surface of the shaft section; and

b) applying heat and radially inward pressure on an outer surface of the outer layer to heat the inner and outer layers to fully encapsulate the echogenic member and form a continuous shaft image on a 3D ultrasound image format.

9. The catheter of claim 8 wherein the outer layer has metallic or glass echogenic particles, and the inner layer consists essentially of polymeric material.

10. The catheter of claim 9 wherein the outer layer has tungsten particles at a percent loading of 10% to 35%.

11. The catheter of claim 8 wherein the outer layer is formed at least in part of a different polymeric material than the inner layer.

12. A method of making a catheter for use in a patient'"'"'s body lumen, configured for being viewed under ultrasonic imaging using an ultrasound imaging system outside of the patient'"'"'s body lumen, comprising:

a) applying an echo diffusive and dampening polymeric inner layer having an acoustic impedance and an echo diffusive and dampening polymeric outer layer having an acoustic impedance different from the inner layer, with an echogenic member therebetween, on an outer surface of the shaft section; and

b) applying heat and radially inward pressure on an outer surface of the outer layer to heat the inner and outer layers to fully encapsulate the echogenic member and form a discontinuous shaft image on a 3D ultrasound image format.

13. The catheter of claim 12 wherein the outer layer has metallic or glass echogenic particles, and the inner layer consists essentially of polymeric material.

14. The catheter of claim 13 wherein the outer layer has tungsten particles at a percent loading of 10% to 35%.

15. The catheter of claim 12 wherein the outer layer is formed at least in part of a different polymeric material than the inner layer.

16. A method of making a catheter for use in a patient'"'"'s body lumen, configured for being viewed under ultrasonic imaging using an ultrasound imaging system outside of the patient'"'"'s body lumen, comprising:

a) applying an echo diffusive and dampening polymeric inner layer having an acoustic impedance and an echo diffusive and dampening polymeric outer layer having an acoustic impedance different from the inner layer, with an echogenic member therebetween, on an outer surface of the shaft section; and

b) applying heat and radially inward pressure on an outer surface of the outer layer to heat the inner and outer layers to fully encapsulate the echogenic member and form a continuous shaft image on a 3D ultrasound image format.

17. The catheter of claim 16 wherein the outer layer has metallic or glass echogenic particles, and the inner layer consists essentially of polymeric material.

18. The catheter of claim 17 wherein the outer layer has tungsten particles at a percent loading of 10% to 35%.

19. The catheter of claim 16 wherein the outer layer is formed at least in part of a different polymeric material than the inner layer.