Echogenic stent

• US 20040230119A1
• Filed: 05/11/2004
• Published: 11/18/2004
• Est. Priority Date: 05/15/2003
• Status: Abandoned Application

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Brustad, John R., Pinedjian, Raffi S.
• Application Number:
  US10/844,231
• Publication Number:
  US 20040230119A1
• Time in Patent Office: Days
• US Class Current: 600/442
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

An echogenic medical device such as a stent for insertion into a biological tissue or vessel comprising an elongate tube and having at least one lumen extending substantially along a longitudinal axis. The elongate tube comprises a material having an acoustic impedance different from the acoustic impedance of the biological tissue or vessel of a patient body such that ultrasonic imaging of the tube inside the patient'"'"'s body may be achieved. The elongate tube may comprise a plastic material such as polyethylene or any formable, pliable material which may be molded and/or extruded to a variety of shapes depending upon a specific application. The invention improves ultrasonic imaging by entrapping air in a lumen of the stent, which may have any cross-sectional shape and which may be sealed anywhere along the longitudinal axis. The stent may include curled ends for positioning the stent in a body vessel, a plurality of holes for draining fluid in a body tissue, and additional lumen to entrap air and to further enhance ultrasonic imaging of the stent. The coils of the curled ends may also be tightly spaced together to provide ultrasound reflection. In another aspect of the invention, a material such as a foaming agent may be added during the extrusion process to cause the formation of CO₂ gas to form in the material as it is being extruded. In yet another aspect of the invention, a mesh stent may be used to advantage either by modifying the individual elements to be more echogenic or by adjusting the braid configuration to be more reflective.

Claims

1. An echogenic stent adapted to be placed into a biological tissue or vessel of a patient, comprising:

an elongate tube having a lumen extending substantially along a longitudinal axis,

the tube being adapted to be advanced to a desired location of the biological tissue or vessel, and

at least a portion of the lumen being sealed to entrap air to enhance ultrasonic reflection.

2. The echogenic stent of claim 1, wherein the lumen comprises a first lumen and a second lumen, the first lumen being adapted to be advanced to the desired location of the biological tissue or vessel, and at least a portion of the second lumen being sealed to entrap air to enhance ultrasonic reflection.

3. The echogenic stent of claim 2, wherein the first lumen is further adapted to drain fluid from the biological tissue or vessel.

4. The echogenic stent of claim 1, wherein the elongate tube comprises a material having an acoustic impedance different from the acoustic impedance of the biological tissue or vessel.

5. The echogenic stent of claim 1, wherein the elongate tube is formed from a plastic material molded or extruded to a desired shape.

6. The echogenic stent of claim 1, further comprising a coiled spring formed into the elongate tube to facilitate kink resistance and ultrasonic reflection.

7. The echogenic stent of claim 6, wherein spacing between the spring coils may be varied to adjust the amount of ultrasonic reflection.

8. The echogenic stent of claim 1, further comprising a curled end at a distal end of the elongate tube to facilitate positioning of the stent in the biological tissue or vessel.

9. The echogenic stent of claim 8, further comprising a curled end at a proximal end of the elongate tube.

10. The echogenic stent of claim 8, wherein the curled end comprises a plurality of holes or ports operably connected to the lumen to facilitate drainage of fluid from the biological tissue or vessel.

11. The echogenic stent of claim 1, wherein the lumen has a diameter ranging from about 0.25 mm to about 6 mm.

12. The echogenic stent of claim 1, wherein the lumen has a diameter of about 1 mm.

13. The echogenic stent of claim 8, wherein the curled end comprises coils that are spaced apart to provide ultrasonic reflection.

14. The echogenic stent of claim 13, wherein the coils are spaced from about 0.25 mm to about 6 mm apart.

15. The echogenic stent of claim 13, wherein the coils are spaced about 1 mm apart.

16. The echogenic stent of claim 2, wherein each of the first and second lumen has a cross-section of any geometric shape including circular, oval, square, triangular, rectangular, pentagonal and hexagonal.

17. An medical device adapted to be placed into a biological tissue or vessel of a patient, comprising:

an elongate tube having a lumen extending along a longitudinal axis; and

a plurality of porous particles or air bubbles formed along a portion of the elongate tube,

the tube being adapted to be advanced to a desired location of the biological tissue or vessel, and

the plurality of porous particles or air bubbles being formed along the portion of the tube to enhance ultrasonic reflection.

18. The medical device of claim 17, wherein the lumen is further adapted to drain fluid from the biological tissue or vessel.

19. The medical device of claim 17, wherein the elongate tube is formed from a plastic material.

20. The medical device of claim 19, wherein the plastic material is extruded to a desired shape.

21. The medical device of claim 20, further comprising a foaming agent added during the extrusion process to cause formation of CO₂ gas to form in the elongate tube.

22. An echogenic stent adapted to be placed into a biological tissue or vessel of a patient, comprising:

an elongate tube having a lumen extending substantially along a longitudinal axis; and

a braid or mesh having a plurality of individual elements formed around a portion of the elongate tube,

the tube being adapted to be advanced to a desired location of the biological tissue or vessel, and

the braid or mesh being formed around a portion of the tube to enhance ultrasonic reflection.

23. The echogenic stent of claim 22, wherein the lumen is further adapted to drain fluid from the biological tissue or vessel.

24. The echogenic stent of claim 22, wherein the amount of ultrasonic reflection is partially determined by the configuration of the braid or mesh.

25. The echogenic stent of claim 24, wherein the amount of ultrasonic reflection is adjusted by adjusting the individual elements of the braid or mesh.

26. A process of manufacturing an echogenic stent adapted to be placed into a biological tissue or vessel of a patient, comprising:

forming an elongate tube from a formable material having a lumen;

sealing at least a portion of the lumen to entrap air to enhance ultrasonic reflection; and

shaping the elongate tube to a desired shape to be placed into the biological tissue or vessel of the patient.

27. The process of claim 26, wherein the material is a thermoplastic and the forming step further comprises heating the formable material in a molten or liquid state to form the elongate tube.

28. The process of claim 26, wherein the material is a thermoset and the forming step further comprises a chemical reaction or process to form the elongate tube.

29. The process of claim 26, wherein the material includes a thermoplastic having an acoustic impedance different from the acoustic impedance of the biological tissue or vessel.

30. The process of claim 26, wherein the elongate tube further comprises a curled end at a distal end to facilitate positioning of the stent in the biological tissue or vessel.

31. The process of claim 30, wherein the curled end comprises a plurality of holes or ports operably connected to the lumen to facilitate drainage of fluid from the biological tissue or vessel.

32. The process of claim 26, further comprising mixing sound reflective particles into the formable material.

33. The process of claim 32, wherein the sound reflective particles include at least one of hard plastic, sand and metal particles to further enhance ultrasonic reflection.

34. The process of claim 26, further comprising adding foaming agent to the material to cause formation of CO₂ gas to form in the elongate tube.

35. A medical device, comprising:

a distal section having a first flexibility and a first length; and

a proximate section having a second flexibility and a second length,

wherein a portion of at least the distal section and the proximate section includes a plurality of porous particles or air bubbles to enhance ultrasonic reflection.

36. The medical device of claim 35, wherein the device is a guidewire, a needle or a catheter.

37. A ureteral access sheath, comprising:

an elongate tube having a first lumen extending between a proximal end and a distal end; and

a handle disposed at the proximal end of the tube having a flared configuration, a first surface facing generally distally, and a second surface facing generally proximally and configured to funnel instrumentation into the lumen,

the elongate tube further comprises a second lumen, at least a portion of the second lumen being sealed to entrap air to enhance ultrasonic reflection.

38. The ureteral access sheath of claim 37, further comprising a coiled spring molded into the elongate tube to facilitate kink resistance and ultrasonic reflection.

39. The ureteral access sheath of claim 38, wherein spacing between the spring coils may be varied to adjust the amount of ultrasonic reflection.

40. The ureteral access sheath of claim 37, wherein the first surface is concave.

41. The ureteral access sheath of claim 40, wherein the second surface is convex.

42. The ureteral access sheath of claim 37, wherein the first surface is convex.

43. The ureteral access sheath of claim 42, wherein the second surface is concave.