Catheter system for delivery of a ureteral catheter

Abstract

A catheter system for delivery of a ureteral catheter in a ureter includes a ureteral catheter, a pusher catheter to deliver the ureteral catheter at a desired location, a connection device, to connect, in an assembled state a distal end of the pusher catheter to a proximal end of the ureteral catheter, where, in the assembled state, the catheter system is configured and to deliver, when desired, fluid contrast agent near a proximal end of the ureteral catheter. The catheter system is also configured to deliver, when desired, fluid contrast agent near a distal end of the ureteral catheter.

Claims

1. A catheter system for delivery of a ureteral catheter in a ureter, comprising: a ureteral catheter, a pusher catheter to deliver the ureteral catheter at a desired location, and a releasable connection device, to connect, in an assembled state a distal end of the pusher catheter to a proximal end of the ureteral catheter, wherein the catheter system comprises a first contrast agent channel to deliver, when desired, fluid contrast agent near a distal end of the ureteral catheter and a second contrast agent channel to deliver, when desired, fluid contrast agent near the proximal end of the ureteral catheter, wherein the first contrast agent channel and the second contrast agent channel are separate channels, and wherein the first contrast agent channel and the second contrast agent channel run at least partially through the pusher catheter.

2. The catheter system of claim 1, wherein the ureteral catheter comprises a guide wire lumen and an auxiliary lumen, both extending from a proximal end of the ureteral catheter to a distal end of the ureteral catheter, wherein the pusher catheter comprises a second guide wire lumen and a second auxiliary lumen, both extending from a proximal end of the pusher catheter to a distal end of the pusher catheter, wherein, in the assembled state, a combination of the auxiliary lumen and one of the second auxiliary lumen and the second guide wire lumen forms the first contrast agent channel to deliver fluid contrast agent near the distal end of the ureteral catheter, and wherein the other of the second guide wire lumen and the second auxiliary lumen forms the second contrast agent channel to deliver fluid contrast agent near the proximal end of the ureteral catheter.

3. The catheter system of claim 2, wherein the other of the second guide wire lumen and the second auxiliary lumen comprises a fluid contrast agent outlet port near a distal end of the pusher catheter.

4. The catheter system of claim 2, wherein the pusher catheter comprises a side inlet port configured to introduce fluid contrast agent into the second auxiliary lumen.

5. The catheter system of claim 2, wherein the connection device comprises a mini tube arranged, in the assembled state, in a proximal end of the auxiliary lumen and a distal end of the second auxiliary lumen, therewith providing a fluid connection between the auxiliary lumen and the second auxiliary lumen and forming the first contrast agent channel.

6. The catheter system of claim 2, wherein a fluid connection between the second guide wire lumen in the pusher catheter and the auxiliary lumen in the ureteral catheter to form the first contrast agent channel is formed by a cross slot in a proximal end surface of the ureteral catheter and/or in a distal end surface of the pusher catheter.

7. The catheter system of claim 2, wherein the catheter system comprises a guide wire, and wherein an inner diameter of at least a proximal part of the guide wire lumen is substantially the same or slightly larger than the outer diameter of the guide wire to provide a contrast agent seal between the guide wire lumen and the second guide wire lumen without obstructing relative movement of the ureteral catheter and the guide wire, when arranged in the guide wire lumen.

8. The catheter system of claim 2, wherein the catheter system comprises a guide wire, and a sealing device to provide a contrast agent seal between the guide wire lumen and the second guide wire lumen without obstructing relative movement of the ureteral catheter and the guide wire, when arranged in the guide wire lumen.

9. The catheter system of claim 2, wherein the catheter system comprises a Y-connection device connected on the proximal end of the pusher catheter, wherein the Y-connection device comprises a second side inlet port configured to introduce fluid contrast agent into the second guide wire lumen.

10. The catheter system of claim 1, wherein the catheter system comprises a valve system to deliver fluid contrast agent from a single contrast agent source connected to a single contrast agent inlet port of the catheter system selectively near a distal end of the ureteral catheter and/or near a proximal end of the ureteral catheter.

11. The catheter system of claim 1, wherein the pusher catheter comprises a fluid contrast agent outlet port near a distal end of the pusher catheter to deliver fluid contrast agent near the proximal end of the ureteral catheter, wherein the fluid contrast agent outlet port is in fluid communication with a guide wire lumen or an auxiliary lumen of the pusher catheter.

12. The catheter system of claim 1, wherein the ureteral catheter comprises a guide wire lumen and an auxiliary lumen, wherein the guide wire lumen comprises side drainage openings between at least a proximal opening and a distal opening of the guide wire lumen, and wherein the auxiliary lumen is a closed channel between a proximal opening and a distal opening of the auxiliary lumen to transport fluid contrast agent from the proximal opening to the distal opening of the auxiliary lumen.

13. The catheter system of claim 1, wherein the ureteral catheter is a double J catheter or a ureteral balloon catheter.

14. Use of a catheter system according to claim 1 for the treatment of a diseased ureter of a patient, comprising: inserting, in assembled state, the combination of ureter catheter and pusher catheter into the patient to place the ureter catheter in the ureter to be treated; releasing at a desired location the ureteral catheter from the pusher catheter; retracting the pusher catheter from of the patient, and ejecting fluid contrast agent near the distal end and/or near the proximal end of the ureteral catheter during the step of inserting and/or releasing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further characteristics and advantages of the invention will now be elucidated by a description of embodiments of the invention, with reference to the accompanying drawings, in which:

(2) FIG. 1 shows a perspective view of a ureteral catheter according to an embodiment of the invention;

(3) FIG. 2a shows a cross section A-A of the ureteral catheter of FIG. 1;

(4) FIG. 2b shows a cross section B-B of the ureteral catheter of FIG. 1;

(5) FIG. 3 shows a side view of a pusher catheter according to an embodiment of the invention;

(6) FIG. 4 shows a cross section C-C of the pusher catheter of FIG. 3;

(7) FIG. 5 shows a side view of a first embodiment of a catheter system according to the invention;

(8) FIG. 5a shows a longitudinal cross-section of a part of the catheter system of FIG. 5;

(9) FIG. 6 shows a side view of a second embodiment of a catheter system according to the invention; and

(10) FIG. 6a shows a longitudinal cross-section of a part of the catheter system of FIG. 6.

DETAILED DESCRIPTION OF THE INVENTION

(11) FIG. 1 shows a perspective view of a ureteral catheter, in particular a double J catheter, generally indicated by reference numeral 1. The ureteral catheter 1 comprises an elongate body 2 having a proximal end 3 and a distal end 4. The proximal end 3 comprises a widened connector element 5, also referred to as overmould, to connect the ureteral catheter 1 to a pusher catheter. This connector element 5 may be made of relative hard material compared to the further parts of the ureteral catheter to make a more reliable connection to the pusher catheter possible.

(12) The ureteral catheter 1 is configured to be placed in the ureter to be treated typically to restore and/or ensure patency of the ureter. After positioning of the ureteral catheter 1 in the ureter, the ureteral catheter 1 will extend from the bladder to the pyelum.

(13) The proximal end 3 and the distal end 4 are formed as a pigtail or coil to make sure that the respective ends remains properly positioned in the bladder and pyelum in which it is placed. The proximal end 3 and the distal end 4 of the ureteral catheter are suitable to be placed in both the pyelum and the bladder, dependent on the direction of introduction into the ureter.

(14) FIG. 2a shows a cross-section A-A of the ureteral catheter 1 in the elongate middle part thereof. The ureteral catheter 1 comprises a guide wire lumen 6 and a contrast agent lumen 7. Both the guide wire lumen 6 and the contrast agent lumen 7 run from the proximal end 3 of the ureteral catheter 1 to the distal end 4 of the ureteral catheter 1. At least over the relative straight middle part of the ureteral catheter 1, the contrast agent lumen 7 is a closed channel, i.e. fluid tight to the outer surface of the ureteral catheter 1 such that from a proximal opening at the proximal end of the ureteral catheter 1, contrast agent can be transported to a distal opening at the distal end of the ureteral catheter 1.

(15) The guide wire lumen 6 may have a number of drainage openings 9 along the length of the guide wire lumen to promote fluid flow through the ureter after placement of the ureteral catheter. These drainage openings 9 may improve the drainage effect of the ureteral catheter 1.

(16) At the proximal end 3 and the distal end 4, the guide wire lumen 6 and the contrast agent lumen 7 comprise one or more openings to the outer side of the ureteral catheter 1. The distal end 4 of the ureteral catheter 1 may be tapered, preferably towards a diameter slightly larger than the guide wire lumen 6. The distal end of the contrast agent lumen 7 may be formed by an elongate opening or a side opening, for example in the tapered distal end of the ureteral catheter. The elongate opening or the side opening part is preferably designed to avoid or minimize scraping thereof against an inner wall of the ureter or other part of the patient's body.

(17) The guide wire lumen 6 is configured to receive a guide wire 10, indicated by dashed lines in FIG. 2. The guide wire 10 can be used to guide the ureteral catheter 1 to the desired location in the ureter.

(18) The diameter of the guide wire lumen 6 is substantially larger than the diameter of the guide wire 10 to obtain a space between the inner surface of the guide wire lumen 6 and the outer surface of the guide wire 10. This space can be used for the transport of fluid through the ureteral catheter when the guide wire 10 is still arranged in the guide wire lumen 6.

(19) The contrast agent lumen 7 is configured to transport contrast fluid from the proximal end 3 to the distal end 4 to eject the contrast fluid at or near the distal end 4 of the ureteral catheter 1 during insertion and positioning of the ureteral catheter 1 in the ureter. In this embodiment, the diameter of the contrast agent lumen 7 is smaller than the diameter of the guide wire lumen 6.

(20) FIG. 2b shows a cross-section B-B of the ureteral catheter 1 at the connector element 5. Also in this cross-section the guide wire lumen 6 and the contrast agent lumen 7 running over the length of the ureteral catheter 1 are shown.

(21) In the connector element 5, the diameter of the guide wire lumen 6 is substantially the same as or slightly larger than the diameter of the guide wire 10 to obtain a relative tight fit between guide wire lumen 6 and guide wire, however without obstructing movement of the guide wire 10 with respect to the ureteral catheter 1. This tight fit is useful to make release of the ureteral catheter 1 from the pusher catheter 20 possible as well as to avoid that contrast agent may enter the guide wire lumen 6 of the ureteral catheter 1, as will be discussed hereinafter.

(22) FIG. 3 shows an embodiment of a pusher catheter 20. The pusher catheter 20 comprises an elongate pusher catheter body 21 and a Y shaped part 22. The pusher catheter 20 has a distal end 23. At the distal end 23 a distally extending cover tube 24 is provided to receive the connector element 5 of the ureteral catheter 1. By arranging the connector element 5 in the cover tube 24, the proximal end 3 of the ureteral catheter 1 may be connected to the distal end 23 of the pusher catheter 20. Additionally, or as an alternative, other connection means may be provided to couple the ureteral catheter 1 and the pusher catheter 20.

(23) FIG. 4 shows a cross section C-C of the pusher catheter 20. The pusher catheter 20 comprises a second guide wire lumen 25 and a second contrast agent lumen 26. Both the second guide wire lumen 25 and the second contrast agent lumen 26 run from a proximal end of the pusher catheter 20 to the distal end 23 of the pusher catheter 20. At the proximal end of the pusher catheter 20, the second guide wire lumen 25 is fluidly connected to a main port 27 of the pusher catheter 20 and the second contrast agent lumen 26 is connected to a side port 28 of the pusher catheter 20.

(24) It is remarked that in the shown embodiment of FIGS. 3 and 4, the pusher catheter 20 only comprises one guide wire lumen 25 and one contrast agent lumen 26. The term second is used to distinguish the guide wire lumen 25 and the contrast agent lumen 26 of the pusher catheter 20 from the guide wire lumen 6 and the contrast agent lumen 7 of the pusher catheter 20.

(25) In the guide wire lumen 25 a guide wire 10 is shown, having the same diameter as the guide wire 10 in FIG. 2. The diameter of the second guide wire lumen 25 is larger than the diameter of the guide wire lumen 6. The space 29 in the second guide wire lumen 25 not occupied by the guide wire 10 may be used to transport contrast fluid from the main port 27 to the distal end 23 of the pusher catheter 20.

(26) FIG. 5 shows a catheter system for delivery of a ureteral catheter in a ureter. The catheter system comprises the ureteral catheter 1, as shown in FIG. 1, and a pusher catheter 20, as shown in FIG. 3. On the main port 27 of the pusher catheter 20 a further Y-connector element 40 is mounted. The Y-connector element 40 comprises guide wire port 41 and a contrast agent side port 42. The guide wire port 41 and the contrast agent side port 42 are connected to the same central lumen in the Y-connector element 40 running from the guide wire port 41 to the distal end 43 of the Y-connector element 40, which is mounted on the main port 27 of the pusher catheter 20.

(27) The diameter of the central lumen is selected to be larger than the guide wire 10, for example similar to the diameter of the guide wire lumen 25 of the pusher catheter 20, so that contrast agent can be transported towards the distal end 43 when a guide wire 10 is positioned in the central lumen.

(28) The guide wire port 41 is configured to receive a guide wire 10 in a sealing way so that it is avoided that contrast agent introduced through the contrast agent side port 42 will leave the Y-connector element 40 via the guide wire port 41.

(29) In the assembled state of the catheter system, as shown in FIG. 5, guide wire lumen 6, the second guide wire lumen 25 and the central lumen are aligned so that the guide wire 10 runs from the proximal end of the catheter system at guide wire port 41 to the distal end of the catheter system to leave the ureteral catheter 1 at a guide wire opening at the distal end 4 of the ureteral catheter 1. As a result, of the presence of the guide wire 10 in the guide wire lumen 6 of the ureteral catheter 1, the coiled ends of the ureteral catheter 1, are straightened. When the guide wire 10 is removed from the guide wire lumen 6 the proximal end 3 and the distal end 4 will return to the coiled shape.

(30) The side port 28 of the pusher catheter 20 and the contrast agent side port 42 of the Y-connector element 40 provide the possibility to introduce contrast agent at two locations of the catheter system. Each of the side port 28 and the contrast agent side port 42 is connected to a separate contrast agent channel, one configured to eject fluid contrast agent near the distal end 4 of the ureteral catheter 1 and one configured to eject fluid contrast agent near the proximal end 3 of the ureteral catheter 1.

(31) By delivering contrast agent at both the proximal end 3 and the distal end 4 during insertion and positioning of the ureteral catheter 1 in the ureter, the actual location of the ureteral catheter 1 can be made more visible in an imaging catheter system susceptible for the contrast agent. Furthermore, the possibility of ejecting or dispensing contrast agent near a selected one and/or both ends of the ureteral catheter 1, makes the catheter system suitable to be used in both percutaneous delivery, from kidney to bladder, and cystoscopical delivery, from bladder to kidney, of the ureteral catheter 1 in the ureter.

(32) The advantage of separate contrast agent channels is that contrast agent can be ejected selectively near one or both of the proximal end 3 and the distal end 4 of the ureteral catheter 1. There is no need to provide valve elements or other fluid flow control elements to guide the flow of fluid contrast agent to a selected one of the proximal end 3 and the distal end 4.

(33) In the transition of the pusher catheter 20 to the ureteral catheter 1, the contrast agent flows can be created differently.

(34) FIG. 5a shows a first possibility to create two separate contrast agent channels. In the embodiment of FIG. 5a a connection mini tube 30 is provided in a distal end opening of the second contrast agent lumen 26 and in a proximal end opening of the contrast agent lumen 7. One end of the mini tube 30 may be fixed to the pusher catheter 20, and the other end may be slidable, with some friction, with respect to the proximal end opening of the contrast agent lumen 7.

(35) The connection mini tube 30 provides a further connection between ureteral catheter 1 and pusher catheter 20, and forms a fluid passage from the second contrast agent lumen 26 to the contrast agent lumen 7. As a result, a first contrast agent channel is formed running from the side port 28 to a distal end 4 of the ureteral catheter 1.

(36) Near a distal end 23 of the pusher catheter 20 a contrast agent outlet port 31 is formed providing a fluid connection between the second guide wire lumen 25 and the outer surface of the pusher catheter body 21. As a result, the second guide wire lumen 25 forms a second contrast agent channel from the contrast agent side port 42 to the contrast agent outlet port 31.

(37) Since the contrast agent outlet port 31 is arranged, in the assembled state, close to the proximal end 3 of the ureteral catheter 1, any contrast agent ejected from the contrast agent outlet port 31 will be ejected near the proximal end 3 of the ureteral catheter 1.

(38) As discussed above, the diameter of the guide wire lumen 6 in the connector element 5 is smaller than the diameter of the, in assembled state, axially aligned second guide wire lumen 25. Since the diameter of the guide wire lumen 6 is substantially the same as or only slightly larger than the diameter of the guide wire 10, no or little contrast agent will continue to flow from the second guide wire lumen 25 into the guide wire lumen 6 towards the distal end 3 of the ureteral catheter 1. As a result, substantially all contrast agent introduced at contrast agent side port 42 will be ejected from the pusher catheter 20 at the contrast agent outlet port 31.

(39) It is remarked that this difference in diameter may also be used to release the ureteral catheter 1 from the pusher catheter 20 by introducing a pusher element, for example a push rod, also called stylet, into the second guide wire lumen 25. When this pusher element has a smaller diameter than the second guide wire lumen 25, but a larger diameter than the guide wire lumen 6 in the connector element 5, the pusher element cannot, when advanced in the second guide wire lumen 25 enter the guide wire lumen 6, and will abut against the proximal end surface of the ureteral catheter 1. By exerting a force on the pusher element positioned against the proximal end surface of the ureteral catheter 1, the ureteral catheter 1 can be pushed away from the pusher catheter 20 and released when the connector element 5 is completely pushed out of the cover tube 14.

(40) It is further remarked that for this release of the ureteral catheter 1 from the pusher catheter also other shapes or devices may be used, such as an oval cross-section of the guide wire lumen at the connector element 5 having a minimal diameter smaller than the diameter of the pusher element, or the provision of one or more stop elements such as extensions extending into the guide wire lumen at the proximal end thereof to prevent entrance of the pusher element into the guide wire lumen 6 of the ureteral catheter 1.

(41) FIGS. 6 and 6a show a second embodiment of a catheter system according to the invention. The same parts or parts having substantially the same function are indicated by the same reference numerals.

(42) The catheter system comprises a ureteral catheter 1, a pusher catheter 20, and a Y-connector element 40. The catheter system of FIGS. 6 and 6a is, in the assembled state, also configured to deliver, when desired, fluid contrast agent near a distal end of the ureteral catheter and, when desired, near a proximal end of the ureteral catheter.

(43) Similar to the embodiment of FIG. 5, the catheter system is configured to provide a first contrast agent flow from the side port 28 via the second contrast agent lumen 26 towards the distal end 23 of the pusher catheter 20, and a second contrast agent flow from the contrast agent side port 42 via the second guide wire lumen 25 towards the distal end 23 of the pusher catheter 20.

(44) FIG. 6a shows a cross section of the transition from the distal end 23 of the pusher catheter 20 to the proximal end 3 of the ureteral catheter 1.

(45) In this embodiment a cross slot 8 is provided in the proximal end 3 of the ureteral catheter 1. The cross slot 8 provides a fluid connection between the second guide wire lumen 25 and the contrast agent lumen 7. The second contrast agent lumen 26 is not in fluid connection with the contrast agent lumen 7.

(46) As a result, a first separate contrast agent channel is formed from the contrast agent side port 42 via the second guide wire lumen 25, cross slot 8 and contrast agent lumen 7 to the distal end 4 of the ureteral catheter 1. This first contrast agent channel is thus suitable to dispense contrast agent near the distal end 4 of the ureteral catheter 1. Again, no or little contrast agent will enter the guide wire lumen 6 due to the relative close fit between the proximal part of the guide wire lumen 6 and the guide wire 10 in the connector element 5.

(47) A second contrast agent channel is formed by the second contrast agent lumen 26 running from the side port 28 to the distal end 23 of the pusher catheter 20. The axial end of this second contrast lumen 26 is closed, but a contrast agent outlet port 31 provides a fluid connection between the second contrast lumen 26 and an outer surface of the pusher catheter 20, so that contrast agent can be ejected from the contrast agent outlet port 31 at the distal end 23 of the pusher catheter, and therefore, in the assembled state, near the proximal end 3 of the ureteral catheter 1.

(48) The different parts of the catheter system may be produced by any suitable method and from any suitable material known in the art. The ureteral catheter and the pusher catheter are preferably made from biocompatible plastics materials. The guide wire is preferably made of a biocompatible metal.

(49) Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.