Echogenic needle catheter configured to produce an improved ultrasound image

• US 7,794,402 B2
• Filed: 05/15/2006
• Issued: 09/14/2010
• Est. Priority Date: 05/15/2006
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Wang, Edwin Y.
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): Selkin; Saurel J
• Application Number:
  US11/435,216
• Publication Number:
  US 20070265516A1
• Time in Patent Office: 1,583 Days
• Field of Search: 600/459, 600/462, 600/461, 600/463, 600/464, 600/466, 600/467, 600/479, 600372-375, 600/385, 600/395
• US Class Current: 600/459
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• 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 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

An echogenic catheter, such as a needle catheter, formed at least in part of an intrinsically conductive organic polymer for providing a highly conductive surface in combination with an improved ability to ultrasonically image the catheter, and a method of performing a medical procedure using a catheter of the invention.

Claims

1. An echogenic catheter, comprising

a) an elongated shaft having a proximal shaft section, a distal shaft section, and a lumen extending therein from a proximal to a distal end of the shaft;

and

b) a polymeric distal tip at the distal end of the elongated shaft, which is formed at least in part of an intrinsically conductive organic polymer having an outer surface with a circumference angle substantially greater than 180 degrees, and which has a distal portion of the shaft lumen extending therein in communication with a proximal portion of the shaft lumen and with a port at a distal end of the distal tip, and which is electrically connected to a conductor extending at least through the distal shaft section such that the distal tip is an electrode, wherein the intrinsically conductive organic polymer is not doped with additional materials to aid electrical conductivity, wherein the conductor comprises a wire electrically connecting the distal tip to a distal end of the shaft to conduct a signal from the distal tip to a signal receiving device for generating an electrocardiogram, wherein the polymeric distal tip is a solid material molded around and in continual contact along a cylindrical outer surface of a metal support of the distal shaft section, and in continual contact along outer surfaces of an end flair of the metal support.

2. The catheter of claim 1 wherein the intrinsically conductive polymer is selected from the group consisting of polyacetylene, polypyrrole, polythiophene, polyaniline, and polypara-phenylene vinylenes.

3. The catheter of claim 1 wherein the tip is a blend of the intrinsically conductive polymer and a low-conductive polymer matrix.

4. The catheter of claim 3 wherein the tip has a wall which is formed of the blend and which has a curved outer surface defining a distal leading face of the catheter having the port therein.

5. The catheter of claim 3 wherein the distal tip includes a radiopaque material different from the intrinsically conductive polymer, such that the distal tip is radiopaque, and wherein the amount of radiopaque material does not interfere with imaging of a surrounding anatomy.

6. The catheter of claim 5 wherein the radiopaque material is distributed within the blend.

7. The catheter of claim 1 wherein the distal tip has a wall formed of a low-conductive polymer and an outer layer formed at least in part of the intrinsically conductive polymer bonded to the low-conductive polymer, the outer layer having an inner surface bonded to the low-conductive polymer wall.

8. The catheter of claim 7 wherein the low-conductive polymer has a functionalized outer surface bonded to the intrinsically conductive polymer outer layer, the functionalized outer surface being a phosphonyl or sulfonyl surface.

9. The catheter of claim 1 wherein the catheter is needle catheter including a needle in the lumen of the shaft, which extends distally from the distal tip port in an extended configuration, and which has a lumen.

10. The catheter of claim 9 wherein the shaft comprises an outer tubular body member, and an inner tubular member therein, wherein the inner tubular member extends distally from a proximal end of the shaft and within the polymeric distal tip, and defines the lumen of the shaft which has the needle therein such that the needle is slidably disposed in the inner tubular member of the shaft.

11. The catheter of claim 1 including a second electrode on a proximal shaft section.

12. The catheter of claim 1 wherein the intrinsically conductive polymer provides the distal tip electrode with a relatively high conductivity of at least about 0.01 S/m.

13. The catheter of claim 1, wherein the conductor comprises an elongated deflection member with a distal end secured to the shaft and a proximal end coupled to the wire, the member is configured for deflecting a distal section of the catheter shaft;

and the wire is configured to double as a deflection wire and as a conduction wire.

14. An echogenic needle catheter, comprising:

a) an elongated shaft having a proximal shaft section, a distal shaft section, a lumen extending therein from a proximal to a distal end of the shaft, and a polymeric distal tip at the distal end of the elongated shaft, wherein the polymeric distal tip is formed at least in part of an intrinsically conductive organic polymer having an outer surface with a circumference angle substantially greater than 180 degrees, has a curved outer surface, an inner surface with a distal portion of the shaft lumen therein in communication with a proximal portion of the shaft lumen and with a port at a distal end of the distal tip, and is electrically connected to a conductor extending at least through the distal shaft section such that the distal tip is an electrode, wherein the intrinsically conductive organic polymer is not doped with additional materials to aid electrical conductivity, wherein the conductor comprises a wire electrically connecting the distal tip to a distal end of the shaft to conduct a signal from the distal tip to a signal receiving device for generating an electrocardiogram, wherein the polymeric distal tip is a solid material molded around and in continual contact along a cylindrical outer surface of a metal support of the distal shaft section, and in continual contact along outer surfaces of an end flair of the metal support; and

b) a needle slidably disposed in the shaft lumen, which extends from the distal tip port in an extended configuration.

15. The needle catheter of claim 14 wherein the distal tip has a wall which is formed of a uniform blend of the intrinsically conductive organic polymer and a low-conductive polymer.

16. The needle catheter of claim 15 including a radiopaque material distributed within the blend, such that the distal tip is radiopaque, and wherein the amount of radiopaque material does not interfere with imaging of the surrounding anatomy.

17. The needle catheter of claim 14 wherein the intrinsically conductive polymer is selected from the group consisting of polyacetylene, polypyrrole, polythiophene, polyaniline, and polypara-phenylene vinylenes.

18. A method of performing a medical procedure within a patient, comprising:

a) advancing within the patient'"'"'s vasculature an echogenic catheter, comprising

i) an elongated shaft having a proximal end, a distal end, and a lumen;

ii) a polymeric distal tip at the distal end of the elongated shaft, formed at least in part of an intrinsically conductive organic polymer having an outer surface with a circumference angle substantially greater than 180 degrees, which has an outer surface, an inner surface with a distal portion of the shaft lumen extending therein in communication with a proximal portion of the shaft lumen and with a port at a distal end of the distal tip, and which is electrically connected to a conductor extending at least through the distal shaft section such that the distal tip is an electrode, wherein the intrinsically conductive organic polymer is not doped with additional materials to aid electrical conductivity, wherein the polymeric distal tip is a solid material molded around and in continual contact along a cylindrical outer surface of a metal support of the distal shaft section, and in continual contact along outer surfaces of an end flair of the metal support;

b) imaging the distal tip within the patient by directing sonic energy at the catheter from an ultrasonic imaging system, to produce an ultrasonic image of the distal tip with eliminated or reduced tip pyramid artifact compared to a distal tip having a metallic tip electrode, and positioning the distal tip at a desired location within the patient; and

c) positioning the intrinsically conductive organic polymer of the distal tip of the catheter into abutting contact with a wall surface of a heart chamber of the patient, such that the distal tip conducts an electrical signal from the heart wall to a signal receiving device electrically connected to the catheter conductor, to thereby generate an electrocardiogram.

19. The method of claim 18 wherein the intrinsically conductive polymer provides the distal tip with a conductivity of about 0.01 to about 100 S/m, and wherein the electrical signal is conducted directly from the heart wall to catheter conductor or ECG by the distal tip.

20. The method of claim 18 wherein the catheter is a needle catheter having a needle in the shaft lumen which extends distally from the distal tip port in an extended configuration, and wherein positioning the distal tip of the catheter into abutting contact with the heart chamber wall positions the distal tip port against the heart chamber wall so that the needle in the extended configuration penetrates the heart chamber wall, and including extending the needle through the port and into the heart chamber wall.