Multiple lumen catheter having a soft tip

• US 7,029,467 B2
• Filed: 07/16/2002
• Issued: 04/18/2006
• Est. Priority Date: 07/16/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Gordon, Mark, Higgins, Michael, Faught, Stacy, West, Dean, Currier, Clifford
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): DeSanto, Matthew F.
• Application Number:
  US10/195,954
• Publication Number:
  US 20040015138A1
• Time in Patent Office: 1,372 Days
• Field of Search: 604/48, 604/500, 604506-508, 604/93.01, 604/164.01, 604/173, 604/264, 604/524, 604/525, 604/526, 604/527, 604540-544, 604533-535, 604/523, 600/481, 600485-487, 600309-310, 600/325, 600/327, 600433-435, 600/466, 600/585, 607/122, 606/481, 606485-487
• US Class Current: 604/525
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/0068 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip

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 flexible 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 system having a multiple lumen catheter with 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; and

a tapered catheter distal tip having a proximal region and a distal region, a proximal end abutting the distal end of the catheter body and a distal end, the catheter tip defining at least one primary lumen aligned with the primary lumen(s) of the catheter body end at least one medical implement lumen aligned with the medical implement lumen(s) of the catheter body, wherein a bending portion of the catheter tip is softer than the catheter body and has sufficient column strength to resist buckling during insertion, 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 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 and is more flexible than the distal region.

2. The system of claim 1, further including:

a medical implement extending through the medical implement lumen of the catheter body and the medical implement lumen of the catheter tip.

3. The system of claim 2, wherein the medical implement is a sensor for measuring physiologic parameters secured to the medical implement lumen only at the distal end of the catheter tip.

4. The system of claim 3, wherein the sensor is secured using adhesive that is only applied along a short portion of the medical implement lumen having an axial length of between 0.5–

3.5 mm.

5. The system of claim 4, 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.

6. The system of claim 2, wherein the medical implement is selected from the group consisting of:

at least one optical fiber;

a pH sensor;

a pressure sensor;

a temperature sensor;

at least one pacing lead;

a pacing probe; and

a pacing electrode.

7. The system of claim 2, wherein the medical implement is a probe that fits through the medical implement lumens and is removable from the catheter.

8. The system of claim 1, wherein the catheter tip has at least two exterior tapered angles.

9. The system of claim 8, wherein the proximal region has a greater taper angle than the distal region.

10. The system of claim 1, wherein the catheter tip is formed of two materials.

11. The system of claim 10, wherein one material comprising a portion that permits passage of ultraviolet light, and another material that provides a radiopaque marker.

12. The system of claim 1, 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.

13. The system of claim 1, 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.

14. The system of claim 1, wherein the catheter tip has a length of at least 76 mm (0.30 inches) such that it is highly flexible when subjected to radial forces.

15. A multiple lumen 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; and

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

16. The multiple lumen catheter of claim 15, further including:

a medical implement extending through the medical implement lumen of the catheter body and the medical implement lumen of the catheter tip.

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

18. The multiple lumen catheter of claim 17, wherein the sensor is secured using adhesive that is only applied along a short portion of the medical implement lumen having an axial length of between 0.5–

3.5 mm.

19. The multiple lumen catheter of claim 18, 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.

20. The multiple lumen catheter of claim 16, wherein the medical implement is selected from the group consisting of:

at least one optical fiber;

a pH sensor;

a pressure sensor;

a temperature sensor;

at least one pacing lead;

a pacing probe; and

a pacing electrode.

21. The multiple lumen catheter of claim 15, wherein the catheter tip has at least two exterior taper angles.

22. The multiple lumen catheter of claim 21, wherein the proximal region has a greater taper angle than the distal region.

23. The multiple lumen catheter of claim 15, 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.

24. The multiple lumen catheter of claim 15, 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.

25. The multiple lumen catheter of claim 15, wherein the catheter tip is formed of two materials.