Central venous catheter having a soft tip and fiber optics

• US 6,999,809 B2
• Filed: 07/16/2002
• Issued: 02/14/2006
• Est. Priority Date: 07/16/2002
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Gordon, Mark, Higgins, Michael, Faught, Stacy, West, Dean, Currier, Clifford
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/196,101
• Publication Number:
  US 20040015061A1
• Time in Patent Office: 1,309 Days
• Field of Search: 600309-310, 600/325, 600/327, 600433-435, 600/466, 600/585, 600/361, 600/381, 600/342, 604/508, 604/523, 604/544, 604/528, 607/122
• US Class Current: 600/342
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026

Abstract

A multiple lumen catheter having a soft, tapered multiple lumen distal tip for insertion into a body vessel. One of the lumens is sized to pass over a guidewire such that the catheter can be inserted into the body vessel using the Seldinger technique. At least one medical implement lumen is used for placement or positioning of a biomedical sensor or other medical implement. For example, at least one optical fiber passing through the medical implement lumen may transmit and receive light at the distal tip for measuring oxygen saturation of the blood. The catheter may have a cylindrical catheter body to which the soft distal tip attaches. The soft tip reduces the possibility of vessel or tissue puncture and abrasion. The tip is constructed of a soft plastic or pliable material that yields easily when force is applied. For example, the tip may be made of a softer material than the catheter body, or if made of the same material, the tip can be configured with thinner walls or a higher air-to-material ratio cross-section. Various geometrical configurations and combinations of materials can be used to decrease the resistance of the tip to an applied load. One particular useful application for the catheter of the present invention is as a central venous catheter equipped with fibers for measuring oximetry. The fibers extend to the distal end of the tip and are preferably secured therein with minimal adhesive so as to limit the stiffness added to the tip. One particular useful construction is to secure the fibers within the medical implement lumen using adhesive only along a length of between about 0.5–3.5 mm.

Claims

1. A multiple lumen central venous catheter having a soft tip, comprising:

a generally tubular catheter body having a proximal end and a distal end, the catheter body defining therein at least one primary lumen and at least one medical implement lumen;

a soft, tapered distal catheter tip having a distal end and a proximal end abutting the distal end of the catheter body, the catheter tip defining therein at least one primary lumen aligned with the at least one primary lumen of the catheter body and at least one medical implement lumen aligned with the at least one medical implement lumen of the catheter body, wherein the catheter tip has a proximal region and a distal region, and wherein the proximal region is more flexible than the distal region and more flexible than the catheter body and forms a bending portion of the catheter tip; and

at least one optical fiber extending through the at least one medical implement lumen of the catheter body and the at least one medical implement lumen of the catheter tip, and being secured thereto only at the distal end of the catheter tip.

2. The central venous catheter of claim 1, wherein the at least one optical fiber extends to a distal face of the catheter tip and is secured thereto.

3. The central venous catheter of claim 1, wherein the optical fiber is secured using adhesive that is only applied along a short portion of the medical implement lumen of the catheter tip having an axial length of between 0.5–

3.5 mm.

4. The central venous catheter of claim 3, wherein the adhesive is cured by ultraviolet light, and wherein a portion of the catheter tip permits passage of ultraviolet light therethrough into the medical implement lumen.

5. The central venous catheter of claim 4, wherein the catheter tip is formed of two materials, one material comprising the portion that permits passage of ultraviolet light, and another material that provides a radiopaque marker.

6. The central venous catheter of claim 1, wherein the catheter tip is tapered to have a smaller diameter on its distal end than on its proximal end and has a proximal region and a distal region, the catheter tip having at least two exterior taper angles, and wherein the proximal region has a greater taper angle than the distal region.

7. The central venous catheter of claim 1, wherein the proximal region is made of a material that has a durometer of less than or equal to 100 Shore A hardness.

8. The central venous catheter of claim 1, wherein the proximal region has a larger air-to-material ratio in transverse cross-section than the distal region.

9. The central venous catheter of claim 8, wherein, in transverse cross-section, both the at least one primary lumen and the at least one medical implement lumen are enlarged in the proximal region relative to the surrounding material in comparison to the relative size of the lumens and material in the distal region, such that the proximal region has a larger air-to-material ratio than the distal region.

10. The central venous catheter of claim 1, wherein the catheter tip has a length of at least 7.6 mm (0.30 inches).

11. A multiple lumen central venous catheter having a soft tip, comprising:

a generally tubular catheter body having a proximal end and a distal end, the catheter body defining therein at least one primary lumen and at least one medical implement lumen;

a soft, tapered distal catheter tip having a distal end and a proximal end abutting the distal end of the catheter body, the catheter tip defining at least one primary lumen aligned with the at least one primary lumen of the catheter body and at least one medical implement lumen aligned with the at least one medical implement lumen of the catheter body, wherein the catheter tip has a proximal region and a distal region and wherein the proximal region is more flexible than the distal region and is more flexible than the catheter body, and wherein the proximal region has a larger air-to-material ratio in transverse cross-section than the distal region.

12. The central venous catheter of claim 11, wherein the catheter tip is tapered to have a smaller diameter on its distal end than on its proximal end and has at least two exterior taper angles, and wherein the proximal region has a greater taper angle than the distal region.

13. The central venous catheter of claim 11, wherein at least one of the proximal and distal regions is made of a material that has a durometer of less than or equal to 100 Shore A hardness.

14. The central venous catheter of claim 11, wherein, in transverse cross-section, both the primary lumen and the medical implement lumen are enlarged in the proximal region relative to the surrounding material in comparison to the relative size of the lumens and material in the distal region, such that the proximal region has a larger air-to-material ratio than the distal region.

15. The central venous catheter of claim 11, wherein the catheter tip is formed of two materials.

16. The central venous catheter of claim 11, further comprising a medical implement extending through the medical implement lumen of the catheter body and the medical implement lumen of the catheter tip.

17. The central venous catheter of claim 16, wherein the medical implement is a sensor for measuring physiologic parameter secured to the medical implement lumen only at the distal end of the catheter tip.

18. A multiple lumen central venous catheter having a soft tip, comprising:

generally tubular catheter body having a proximal end and a distal end, the catheter body defining therein at least one primary lumen and at least one medical implement lumen;

a soft, tapered distal catheter tip having a distal end and a proximal end abutting the distal end of the catheter body, the catheter tip defining at least one primary lumen aligned with the at least one primary lumen of the catheter body and at least one medical implement lumen aligned with the at least one medical implement lumen of the catheter body, wherein the catheter tip has a proximal region and a distal region, and wherein the proximal region has a larger air-to-material ratio in transverse cross-section than the distal region, wherein the catheter tip has sufficient column strength to resist buckling during insertion using the Seldinger technique over a guidewire, but is sufficiently flexible to deform when the tip is subjected to axial or radial loads in the body in the absence of the guidewire; and

a sensor extending through the at least one medical implement lumen of the catheter body and the at least one medical implement lumen of the catheter tip.

19. The central venous catheter of claim 18, wherein the sensor is secured only at the distal end of the catheter tip.

20. The central venous catheter of claim 19, wherein the sensor is secured using adhesive and adhesive is only applied along a short portion of the medical implement lumen having an axial length of between 0.5–

3.5 mm.

21. The central venous catheter of claim 20, wherein the adhesive is cured by ultraviolet light, and wherein a portion of the catheter tip permits passage of ultraviolet light therethrough into the medical implement lumen.

22. The central venous catheter of claim 18, wherein the catheter tip is formed of two materials.

23. The central venous catheter of claim 18, wherein the sensor is selected from the group consisting of:

one or more optical fibers;

a pH sensor;

a pressure sensor;

a temperature sensor;

at least one pacing lead;

a pacing probe; and

a pacing electrode.

24. The central venous catheter of claim 18, wherein the catheter tip has a proximal region and a distal region, and wherein the distal region has a different durometer than the proximal region.

25. The central venous catheter of claim 18, wherein the catheter tip has a proximal region and a distal region, and wherein at least one of the proximal and distal regions is made of a material that has a durometer of less than or equal to 100 Shore A hardness.

26. The central venous catheter of claim 18, wherein the catheter tip has a proximal region and a distal region, and wherein one of the proximal region and the distal region is more flexible than the other region.

27. The central venous catheter of claim 18, wherein the catheter tip is tapered to have a smaller diameter on its distal end than on its proximal end and has a proximal region and a distal region, and at least two exterior tapered angles, and wherein the proximal region has a greater taper angle than the distal region.

28. The central venous catheter of claim 18, wherein the sensor is a probe that fits through the medical implement lumens and is removable from the catheter.

29. A multiple lumen central venous catheter having a soft tip, comprising:

a generally tubular catheter body having a proximal end and a distal end, the catheter body defining therein at least one primary lumen and at least one medical implement lumen;

a soft, tapered distal catheter tip having a distal end and a proximal end abutting the distal end of the catheter body, the catheter tip defining at least one primary lumen aligned with the at least one primary lumen of the catheter body and at least one medical implement lumen aligned with the at least one medical implement lumen of the catheter body, wherein the catheter tip has sufficient column strength to resist buckling during insertion using the Seldinger technique over a guidewire, but is sufficiently flexible to deform when the tip is subjected to axial or radial loads in the body in the absence of the guidewire; and

a sensor extending through the at least one medical implement lumen of the catheter body and the at least one medical implement lumen of to catheter tip and secured only at the distal end of the catheter tip.

30. The central venous catheter of claim 29, wherein the sensor is secured using adhesive and adhesive is only applied along a short portion of the medical implement lumen having an axial length of between 0.5–

3.5 mm.

31. The central venous catheter of claim 30, wherein the adhesive is cured by ultraviolet light, and wherein a portion of the catheter tip permits passage of ultraviolet light therethrough into to medical implement lumen.

32. The central venous catheter of claim 29, wherein the catheter tip is formed of two materials.

33. The central venous catheter of claim 29, wherein the catheter tip has a proximal region and a distal region, and wherein the distal region has a different durometer than the proximal region.

34. The central venous catheter of claim 29, wherein the catheter tip has a proximal region and a distal region, and wherein at least one of the proximal and distal regions is made of a material that has a durometer of less than or equal to 100 Shore A hardness.

35. The central venous catheter of claim 29, wherein the catheter tip has a proximal region and a distal region, and wherein one of the proximal region and the distal region is more flexible than the other region.

36. The central venous catheter of claim 29, wherein the catheter tip is tapered to have a smaller diameter on its distal end than on its proximal end and has a proximal region and a distal region, and at least two exterior tapered angles, and wherein the proximal region has a greater taper angle than the distal region.

37. The central venous catheter of claim 29, wherein the sensor comprises one or more optical fibers.

38. The central venous catheter of claim 29, wherein the sensor is selected from the group consisting of:

a pH sensor;

a pressure sensor;

a temperature sensor;

at least one pacing lead;

a pacing probe; and

a pacing electrode.

39. A multiple lumen central venous catheter having a soft tip, comprising:

a generally tubular catheter body having a proximal end and a distal end, the catheter body defining therein at least one primary lumen and at least one medical implement lumen;

a soft tapered distal catheter tip having a distal end and a proximal end abutting the distal end of the catheter body, the catheter tip defining therein at least one primary lumen aligned with the at least one primary lumen of the catheter body and at least one medical implement lumen aligned with the at least one medical implement lumen of the catheter body; and

at least one optical fiber extending through the at least one medical implement lumen of the catheter body and the at least one medical implement lumen of the catheter tip, and being secured thereto only at the distal end of the catheter tip, wherein the optical fiber is secured using adhesive that is only applied along a short portion of the medical implement lumen of the catheter tip having an axial length of between 0.5–

3.5 mm, wherein the adhesive is cured by ultraviolet light, and wherein the catheter tip is formed of two materials, one material comprising a portion of the catheter tip that permits passage of ultraviolet light therethrough into the medical implement lumen, and another material that provides a radiopaque marker.