Echogenic needle catheter configured to produce an improved ultrasound image

• US 7,867,169 B2
• Filed: 12/02/2005
• Issued: 01/11/2011
• Est. Priority Date: 12/02/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Chow, Mina, Webler, William E.
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): Selkin; Saurel J
• Application Number:
  US11/293,420
• Publication Number:
  US 20070167822A1
• Time in Patent Office: 1,866 Days
• Field of Search: 600/459, 600461-464, 600/466, 600/467, 600/479, 600/486
• US Class Current: 600/463
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• 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 25/0009 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 25/0052 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 25/0069 Tip not integral with tube
• 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

Abstract

An echogenic medical device, such as a needle catheter, which produces an improved ultrasonic image of the device, and a method of performing a medical procedure using a device of the invention. One aspect is directed to a catheter which reduces artifacts in the ultrasound image of the catheter. In one embodiment, the catheter has a spherical distal tip. Another aspect of the invention is directed to an echogenic catheter with echogenic portions arranged in an array to facilitate determination by ultrasonic imaging of the rotational orientation of the catheter relative to a desired location within the patient.

Claims

1. An echogenic needle catheter, comprising:

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

b) a spherical distal tip at the distal end of the elongated shaft, having an outer surface with a circumference angle substantially greater than 180 degrees, having a rigid outer diameter wall with a curved outer surface formed at least in part of a rigid polymeric material, and having a lumen in communication with a proximal section of the needle lumen of the shaft and with a port at a distal end of the spherical distal tip, wherein the spherical distal tip is formed at least in part of an electrically conductive material, and the spherical distal tip is in continuous contact with the lumen;

c) a needle in the needle lumen of the shaft, which extends distally from the spherical distal tip port in an extended configuration, and which has a lumen; and

d) a conductor electrically connected to the spherical distal tip and extending through the shaft to the proximal end, so that the spherical distal tip is an electrode, the conductor including an elongated deflection member with a distal end secured to the shaft, configured for deflecting a distal section of the catheter shaft.

2. The needle catheter of claim 1 wherein the wall is a nonconductive polymer and the tip further includes a metallic pin member within the polymeric wall, the pin member having an exposed distal end distal to the polymeric wall.

3. The needle catheter of claim 2 wherein the metallic pin member is electrically connected to a conductor, so that the spherical distal tip is an electrode.

4. The needle catheter of claim 1 wherein the wall has an outer layer defining an outer surface of the spherical distal tip formed of a metallic material.

5. The needle catheter of claim 1 wherein the wall defines an outer surface of the spherical distal tip and comprises a mixture of a polymer and a metallic material.

6. The needle catheter of claim 1 wherein the needle has a retracted configuration in which a distal end of the needle is within the spherical distal tip lumen.

7. The needle catheter of claim 1 wherein the spherical distal tip has a spherical distal portion and a conical tip support proximal portion with an outer surface tapering distally.

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

9. The needle catheter of claim 1 wherein the elongated shaft has a quarter or three quarter wavelength impedance matching outer jacket layer extending along at least a portion of a distal section of the shaft proximal to at least a section of the spherical distal tip, the outer jacket comprising a polymeric material with an acoustic impedance which is between an acoustic impedance of blood and an acoustic impedance of the adjacent layer of the section of the shaft underlying the outer jacket layer, such that it more closely matches the acoustic impedance of blood than does the adjacent layer of the section of the shaft underlying the outer jacket layer, so that the outer jacket is configured to decrease the reflected wave ultrasonic signal of the catheter.

10. The needle catheter of claim 9 wherein the outer jacket layer polymeric material is selected from the group consisting of a low density polyethylene, and an elastomer, and the outer jacket layer has an irregular wall thickness forming a rough outer surface.

11. The needle catheter of claim 1, wherein the deflection member includes a proximal end connected to a proximal adapter, and wherein the deflection member extends within a lumen between the proximal adapter and the distal end of the deflection member.

12. The needle catheter of claim 11, wherein the deflection member is connected to a pin disposed in the spherical distal tip, the pin forming the electrode.

13. The needle catheter of claim 1, wherein the spherical distal tip comprises a first material forming a solid shape between the ridged outer diameter wall and an inner surface of the first material that is touching and in continuous contact along an outer surface of a metallic pin member within the spherical distal tip.

14. The needle catheter of claim 1, wherein the spherical distal tip comprises a first material forming a solid shape between the ridged outer diameter wall and an inner surface of the first material that is touching and in continuous contact along an outer surface a metallic pin member within the spherical distal tip.

16. The needle catheter of claim 1, wherein the spherical distal tip comprises a first material forming a solid shape between the ridged outer diameter wall and an inner surface of the first material that is touching and in continuous contact along an outer surface of a metallic pin member within the spherical distal tip.

20. The echogenic medical device of claim 1, wherein the spherical distal tip comprises a first material forming a solid shape between the ridged outer diameter wall and an inner surface of the first material that is touching and in continuous contact along an outer surface of a metallic pin member within the spherical distal tip.

15. An echogenic needle catheter, comprising:

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

b) a spherical distal tip at the distal end of the elongated shaft, having an outer surface with a circumference angle substantially greater than 180 degrees, and having a lumen in communication with a proximal section of the needle lumen of the shaft and with a port at a distal end of the spherical distal tip, wherein the spherical distal tip is formed at least in part of an electrically conductive material, and the spherical distal tip is in continuous contact with the lumen;

c) a needle in the needle lumen of the shaft, which extends distally from the spherical distal tip port in an extended configuration, and which has a lumen;

d) a conductor electrically connected to the spherical distal tip, so that the spherical distal tip is an electrode; and

e) a second electrode on a proximal shaft section, wherein the shaft comprises a proximal shaft section having a braided or coiled metal support layer, and the second electrode is electrically connected to the braided or coiled metal support layer.

17. An echogenic needle catheter, comprising:

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

b) a spherical distal tip at the distal end of the elongated shaft, having a lumen in communication with a proximal section of the needle lumen of the shaft and with a port at a distal end of the spherical distal tip, a rigid outer diameter wall with a curved outer surface formed at least in part of a rigid polymeric material, and a high strength support member which is within the spherical distal tip and extending proximally therefrom and which has a proximal end section secured to the distal end of the catheter shaft, wherein the spherical distal tip has a spherical distal portion with a rigid outer surface having an outer diameter greater than an outer diameter of the support member and a conical tip support proximal portion with an outer surface tapering distally towards the spherical distal portion, wherein the spherical distal tip is formed at least in part of an electrically conductive material, and the spherical distal tip is in continuous contact with the lumen; and

c) a needle in the needle lumen, which extends distally from the spherical distal tip port in an extended configuration, and which has a lumen.

18. The needle catheter of claim 17 wherein the wall of the spherical distal tip is a nonconductive polymer, and the high strength support member is a metallic pin member within the polymeric wall, the pin member having an exposed distal end distal to the polymeric wall, and a proximal end section electrically connected to a conductor, so that the spherical distal tip is an electrode.

19. The needle catheter of claim 18 wherein the proximal end section of the metallic pin member has a grooved surface with a channel configured to receive the distal end of the conductor therein.

21. An echogenic medical device, comprising:

a) a shaft having a proximal end, a distal end, and a lumen;

b) a spherical distal tip at the distal end of the shaft, having an outer surface with a circumference angle substantially greater than 180 degrees, having a rigid outer diameter wall with a curved outer surface formed at least in part of a rigid polymeric material, and having a lumen in communication with a proximal section of the lumen of the shaft and with a port at a distal end of the spherical distal tip, wherein the spherical distal tip is formed at least in part of an electrically conductive material, and the spherical distal tip is in continuous contact with the lumen; and

c) a conductor electrically connected to the spherical distal tip and extending through the shaft to the proximal end, so that the spherical distal tip is an electrode, the conductor including an elongated deflection member with a distal end secured to the shaft, configured for deflecting a distal section of the catheter shaft.

22. The echogenic medical device of claim 21, wherein the spherical distal tip comprises a first material forming a solid shape between the ridged outer diameter wall and an inner surface of the first material that is touching and in continuous contact along an outer surface of the pin.