CATHETER WITH A BALLOON AND A SEPARATE INFLATION LUMEN

Abstract

A catheter (1) includes an elongated member (2) having a proximal end (4) and a distal end (3). An inflatable balloon (5) is arranged on the elongated member in an area of the distal end thereof, the balloon extending from a distal position (6) to a proximal position (7). The elongated member includes an inner lumen (8) extending from the distal end to an end position (9) which is proximal to the balloon. The inner lumen is open at the distal end. The catheter further includes a duct (12) connected to the proximal end and to the balloon at the proximal position. The duct defines a separate lumen to convey a fluid to and from the balloon.

Claims

1. A catheter comprising: an elongated member having a proximal end and a distal end, and an inflatable balloon arranged on the elongated member in an area of the distal end thereof, the balloon extending from a distal position to a proximal position, wherein the elongated member comprises an inner lumen extending from the distal end to an end position proximal to the balloon, the inner lumen being open at the distal end, and the catheter comprises a duct connected to the proximal end and to the balloon at the proximal position, the duct defining a separate lumen to convey a fluid to and from the balloon.

2. The catheter according to claim 1, wherein the duct is freely spirally wound around the elongated member.

3. The catheter according to claim 1, wherein the duct has a cross section in the form of an oval or circle.

4. The catheter according to claim 1, wherein the duct comprises at least one support element being arranged longitudinally along a length of the duct within the separate lumen.

5. The catheter according to claim 1, wherein the elongated member comprises an access opening at the end position, the access opening allowing the passage of a guidewire into and from the inner lumen.

6. The catheter according to claim 1, wherein the elongated member comprises a reinforcement member stretching from the proximal end to the end position.

7. The catheter according to claim 6, wherein the reinforcement member comprises a distal tip which is in the shape of a ramp pointing towards the access opening.

8. The catheter according to claim 6, wherein the elongated member is made of a hollow tube into which the reinforcement member is introduced from the proximal end to the end position.

9. The catheter according to claim 6, wherein the elongated member comprises: a proximal element extending from the proximal end to the end position, the proximal element being made of a solid material and serving as reinforcement member, and a distal element extending from the end position towards the distal end, the distal element including the inner lumen.

10. The catheter according to claim 9, wherein a distal tip of the proximal element is inserted into the inner lumen of the distal element in the area of the end position.

11. The catheter according to claim 9, wherein: the proximal element is made of a metal or metal alloy and the distal element is made of a polymer material.

12. A method for manufacturing a catheter, comprising the following steps: a) providing an elongated member having a proximal end and a distal end, the elongated member and comprising an inner lumen extending from the distal end towards the proximal end to an end position which is distal to the proximal end; b) arranging an inflatable balloon over the elongated member in an area of the distal end, the balloon extending from a distal position to a proximal position; c) providing a duct defining a separate lumen; d) connecting the duct to the proximal end of the elongated member and to the balloon at the proximal positon position; e) connecting the balloon to the elongated member.

13. A method according to claim 12, wherein the duct is freely spirally wound around the elongated member before step d).

14. A method according to claim 12, wherein the balloon is connected to the elongated member at the proximal position at the same time that the duct is connected to the balloon.

15. A method according to claim 12, wherein: prior to the first step a), the elongated member is produced by inserting a reinforcement member into a tube spanning from the proximal end to the distal end, the reinforcement member only extending along a part of the length of the tube, and the part of the tube without the reinforcement member constitutes the inner lumen of the elongated member.

16. A method according to claim 12, wherein prior to step a), the elongated member is produced by assembling a proximal element made of solid material with a distal element that includes the inner lumen.

17. The catheter according to claim 3, wherein the cross-section is an ellipse.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0053] The drawings used to explain the embodiments show:

[0054] FIG. 1 a schematic drawing of a first embodiment of a catheter according to the present invention;

[0055] FIG. 2a a cross section of the catheter in FIG. 1 in the distal section;

[0056] FIG. 2b a cross section of the catheter in FIG. 1 in the proximal section;

[0057] FIG. 3 a longitudinal section of the catheter according to FIG. 1 in the area of the end position;

[0058] FIG. 4 a schematic drawing of a second embodiment of a catheter according to the present invention;

[0059] FIG. 5 a longitudinal section of the catheter according to FIG. 4 in the area of the end positon.

[0060] In the figures, the same components are given the same reference symbols.

PREFERRED EMBODIMENTS

[0061] FIG. 1 is a schematic drawing of a first embodiment of a catheter 1 according to the present invention. The catheter 1 comprises an elongated member 2 having a distal end 3 and a proximal end 4. In the embodiment as shown in FIG. 1, the elongated member 2 is made of a hollow tube 20 of polymeric material. An inner lumen 8 stretches along a part of the length of the elongated member 2 from the distal end 3 to an end position 9. The inner lumen 8 is open at the distal end 3. This allows the introduction of a guidewire 11 into the inner lumen 8.

[0062] In the area of the distal end 3, an inflatable balloon 5 is arranged on said elongated member 2. The balloon 5 is shown in the inflated state. The balloon extends from a distal position 6 to a proximal position 7.

[0063] At the end position 9, the elongated member 2 comprises an access opening 10 which allows the passage of the guidewire 11 out or into the inner lumen 8. The end position 9 is located proximal to the proximal position 7 of the balloon 5. The combination of the inner lumen 8, which is open at the distal end 3, with the access opening 9 allows the use of the catheter 1 as so-called rapid exchange or monorail catheter. The distance between the proximal end 4 and the end position 9 defines a proximal section p of the catheter 1 while the distance between the end position 9 and the distal end 3 defines a distal section d of the catheter 1.

[0064] The catheter 1 further comprises a duct 12 which is connected to the elongated member 2 only at the proximal end 4 and at the proximal position 7. The duct 12 includes a separate lumen which is used as inflation lumen for the balloon 5. Therefore, the separate lumen is in fluid connection with a volume enclosed by the balloon 5 in the area of the proximal position 7. By means of the separate lumen a fluid may be pumped under pressure into the balloon 5 in order to inflate it. For deflating the balloon 5, the fluid is aspirated by applying an underpressure on the separate lumen. The duct 12 is spirally wound around the elongated member 2. Between the connections at the proximal end 4 and at the proximal position 7 the duct 12 is not connected to the elongated member 2, such that the duct 12 is freely movable relative to the elongated member 2.

[0065] At the proximal end 4, the catheter 1 comprises an adapter 15. By means of the adapter 15, the catheter 1 may be connected to further equipment, such as e.g. a source of fluid.

[0066] FIGS. 2a and 2b show two cross sections of the catheter 1 as shown in FIG. 1. In FIG. 2a a cross section in the distal section d of the catheter 1 is shown. The inner lumen 8 is open and comprises the guidewire 11. The cross-section of the hollow tube 20 forming the elongated member 2 is of a round shape. The duct 12 is located closely to the elongated member 2, as the duct 12 is spirally wound around the elongated member 2. The duct 12 is hollow and includes the separate lumen 13. The duct 12 has a cross section in the shape of an ellipse. In order to prevent a collapse of the separate lumen 13, a support element 14 which extends longitudinally along the length of the duct 12 is arranged along a length axis of the duct 12 within the separate lumen 13. The support element connects two opposite faces of the circumferential wall of the duct and keeps those faces at a defined distance from each other.

[0067] FIG. 2b shows a cross section of the catheter 1 in the proximal section p. In the proximal section p, the elongated member 2 comprises a reinforcement member 16 which is introduced into the hollow tube 20 from the proximal end 4 and which extends from said proximal end 4 to the end position 9. The reinforcement member 16 is shaped and sized such as to completely fill the hollow tube 20.

[0068] FIG. 3 shows a longitudinal section of the catheter 1 according to FIG. 1 in the area of the end position 9. At the end position 9, the reinforcement member 16 comprises a distal tip 17 which is in the form of a ramp pointing towards the access opening 10. This configuration of the distal tip 17 guides a guidewire 11 which is introduced into the inner lumen 8 at the distal end 3 and which is subsequently pushed through the inner lumen 8 towards the proximal end 4 automatically towards the access opening 10.

[0069] FIG. 4 is a schematic drawing of a second embodiment of a catheter 1 according to the present invention. Contrary to the first embodiment of the catheter as shown in FIG. 1, the elongated body 2 is made of a proximal element 19 extending from the proximal end 4 to the end position 9 as well as of a distal element 18 extending from the end position 9 to the distal end 3. The distal element 18 is made of a hollow tube which includes the inner lumen 8. The proximal element 19 is made of a rod of solid material. The hollow tube of the distal element 18 is preferably made of a polymeric material while the rod of solid material of the proximal element 19 is made of a wire of a metal or metal alloy. The proximal element 19 serves the function of the reinforcement member 16 in the first embodiment. The distal element 18 and the proximal element 19 are connected together in the area of the end position 9. Otherwise, the catheter 1 according to the second embodiment further comprises the same parts as the catheter 1 according to the first embodiment, namely a balloon 5, an access opening 10, an adapter 15 and a duct 12 with a separate lumen 13.

[0070] FIG. 5 shows a longitudinal section of the catheter according to the second embodiment shown in FIG. 4 in the area of the end positon 9. As may be seen, the proximal element 19 is introduced into the hollow tube of the distal element 18. Both elements are connected together by welding or by means of an adhesive. Like the reinforcement element 16 of the first embodiment, the proximal element 19 made of solid material comprises a distal tip 17 which is shaped like a ramp pointing towards the access opening 10 in order to guide the guide wire towards said access opening 10.