Catheter with a dual lumen monolithic shaft

• US 9,707,380 B2
• Filed: 02/06/2014
• Issued: 07/18/2017
• Est. Priority Date: 07/05/2012
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Qiu, Hua, Lin, Tung-Liang
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US14/174,324
• Publication Number:
  US 20140155823A1
• Time in Patent Office: 1,258 Days
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes

Abstract

Multi-lumen catheter having a monolithic elongate tubular shaft member having a proximal end, a distal end and a longitudinal length therebetween. The tubular shaft member has an outer cross-sectional dimension that varies along the length of the tubular shaft member. The tubular shaft member has an inner core made of a first material and an outer layer made of a second material. The inner core has a first lumen and a second lumen defined therein, the first lumen having a first lumen cross-section and a length extending at least along a portion of the length of the tubular shaft member. The first lumen cross-section is substantially uniform along the length of the first lumen. The second lumen has a second lumen cross-section and a length extending along the length of tubular shaft member. The second lumen cross-section is substantially uniform along the length of the second lumen.

Claims

1. A multi-lumen catheter comprising:

a monolithic elongate tubular shaft member having a proximal end, a distal end and a longitudinal length therebetween, the tubular shaft member having an outer cross-sectional dimension that varies along the length of the tubular shaft member,

the tubular shaft member having an inner core made of a first material, an outer layer made of a second material, and an intermediate tie layer disposed between the inner core and the outer layer, the first material of the inner core defining a first lumen and a second lumen,

the first lumen having a first lumen cross-section and a length extending at least along a portion of the length of the tubular shaft member, the first lumen cross-section being substantially uniform along the length of the first lumen, and

the second lumen having a second lumen cross-section and a length extending along the length of tubular shaft member, the second lumen cross-section being substantially uniform along the length of the second lumen.

2. The catheter according to claim 1, wherein the outer cross-sectional dimension decreases distally along at least a portion of the tubular shaft member.

3. The catheter according to claim 1, wherein the outer cross-sectional dimension changes uniformly along at least a portion of the tubular shaft member.

4. The catheter according to claim 1, wherein the inner core has an outer cross-sectional dimension that varies along the length of the tubular shaft member.

5. The catheter according to claim 1, wherein the first lumen has a substantially circular cross-section configured to receive a guidewire therethrough.

6. The catheter according to claim 1, wherein the length of the first lumen extends the length of the tubular shaft member, the first lumen having a distal port at the distal end of the tubular shaft member and a proximal port at the proximal end of the tubular shaft member.

7. The catheter according to claim 1, further comprising a liner along at least a portion of the length of the first lumen.

8. The catheter according to claim 1, wherein the inner core, the intermediate tie layer, and the outer layer are coextruded.

9. The catheter according to claim 1, wherein the first material is different from the second material.

10. The catheter according to claim 1, wherein the first material comprises at least one of Nylon, Nylon 12, Nylon TR55, transparent amorphous nylon, PEBAX, and high density polyethylene.

11. The catheter according to claim 1, wherein the second material comprises at least one of Pebax 63D, Pebax 70D, and Pebax 72D.

12. The catheter according to claim 1, wherein the intermediate tie layer comprises the first material.

13. The catheter according to claim 1, wherein the intermediate tie layer comprises the second material.

14. The catheter according to claim 1, wherein the first lumen has a distal port at the distal end of the tubular shaft member and a proximal port defined through an external surface of the tubular shaft member and spaced distally from the proximal end of the tubular shaft member.

15. The catheter according to claim 14, wherein the proximal port is defined by a notch extending through the outer layer and intermediate tie layer and into the inner core to intersect the first lumen.

16. The catheter according to claim 1, wherein the intermediate tie layer joins the outer layer to the inner core.

17. The catheter according to claim 16, wherein the intermediate tie layer comprises at least one of Primacor, PET, Polyester Elastomer, PEBAX, and high density polyethylene.

18. The catheter according to claim 1, wherein the tubular shaft member has a proximal section, an intermediate section, and a distal section, and further wherein the outer cross-sectional dimension varies along at least one of the proximal section, the intermediate section and the distal section.

19. The catheter according to claim 18, wherein the outer cross-sectional dimension is substantially uniform along at least one of the proximal section, the intermediate section and distal section.

20. The catheter according to claim 19, wherein the outer cross-sectional dimension is uniform in the proximal section and in the distal section, and the outer cross-sectional dimension tapers in the middle section.

21. The catheter according to claim 1, further comprising a balloon member coupled to the tubular shaft member proximate the distal end thereof, the second lumen having a distal flow port in fluid communication with an interior chamber of the balloon.

22. The catheter according to claim 21, further comprising a distal flow port in fluid communication with the second lumen and disposed within the interior of the balloon.

23. The catheter according to claim 22, wherein the distal flow port is spaced proximally from the distal end of the tubular member, the distal flow port defined by a notch extending through the outer layer and into the inner core to intersect the second lumen.

24. The catheter according to claim 1, wherein the second lumen has at least one of a substantially semicircular cross-section or a substantially circular cross-section.

25. The catheter according to claim 24, wherein the second lumen comprises a plurality of individual inflation lumens.

26. The catheter according to claim 24, wherein the second lumen comprises the substantially semicircular cross-section and the substantially semi-circular cross-section of the second lumen has a straight edge portion proximate the first lumen.

27. The catheter according to claim 26, wherein the second lumen includes a proximal flow port proximate the proximal end of the tubular shaft member, the proximal flow port in fluid communication with the second lumen to receive a pressurized fluid therein.

28. The catheter according to claim 27, further comprising an adaptor coupled to the tubular member, the adaptor having a fluid branch fluidly coupled with the proximal flow port.

29. A method of forming a multi-lumen catheter comprising:

extruding a first material to form an inner core defining a first lumen and a second lumen, the first lumen having a first lumen cross-section and the second lumen having a second lumen cross-section;

providing a tie material around the inner core of the first material to form an intermediate tie layer;

extruding a second material generally surrounding the inner core and the intermediate tie layer to form an extrudate having an outer layer of the second material surrounding the inner core of the first material and the intermediate tie layer, the extrudate having an outer cross-sectional dimension;

drawing a length of the extrudate at a varied speed to vary the outer cross-sectional dimension along the length thereof; and

internally pressurizing the first lumen and the second lumen, respectively, while drawing the extrudate to maintain the first lumen cross-section and the second lumen cross-section; and

cooling the extrudate to form a monolithic elongate tubular shaft member having a proximal end, a distal end and a longitudinal length therebetween, the tubular shaft member having an outer cross-sectional dimension that varies along the length of the tubular shaft member.

30. The method of forming a multi-layer catheter according to claim 29, wherein internally pressurizing the first lumen and the second lumen is adjusted proportionally to draw the length of the extrudate at a varied speed.

31. The method of forming a multi-layer catheter according to claim 29, wherein internally pressurizing the first lumen and the second lumen is increased when drawing the length of the extrudate is increased.

32. The method of forming a multi-layer catheter according to claim 29, wherein extruding the first material and extruding the second material is performed at least one of simultaneously or sequentially.