INSERTION CATHETER HAVING A VALVE BODY

Abstract

A delivery catheter including a valve body having a closeable valve opening for introducing a medical device in insertion direction into, in particular, a blood vessel, the valve opening, when a medical device is not introduced, tapering in the insertion direction, and a sealing section, which in a closed position at least in sections is subject to a pretension, directly adjoins the taper, so that the sealing section, when a medical device is introduced, is actuated from the closed position into an open position in such manner that the sealing section encloses the medical device in a substantially fluid-tight manner.

Claims

1. A delivery catheter comprising a valve body having a closeable valve opening for introducing a medical device in insertion direction into, in particular, a blood vessel, characterized in that the valve body is formed in one piece, and that the valve opening, when a medical device is not introduced, tapers in the insertion direction, and a sealing section, which in a closed position at least in sections is subject to a pretension, directly adjoins the taper, so that the sealing section when a medical device is introduced is actuated from the closed position into an open position in such manner that the sealing section encloses the medical device in a substantially fluid-tight manner, wherein the valve opening tapers in the insertion direction in an arcuate or wave-like or linear manner toward the sealing section and starting from the sealing section expands in the insertion direction in an arcuate or wave-like manner, and wherein the taper and the extension are mirror-symmetrical to a mirror plane extending along the insertion direction through the valve opening.

2. The delivery catheter as recited in claim 1, characterized in that the sealing section in insertion direction is located in the center region, preferably at the center, of the valve opening.

3. The delivery catheter as recited in claim 1, characterized in that the valve opening has an extension directly adjoining the sealing section in the insertion direction and expanding when a medical device is not introduced.

4. The delivery catheter as recited in claim 1, characterized in that the valve opening is mirror-symmetrical to a mirror plane extending transverse to the insertion direction through the sealing section.

5. The delivery catheter as recited in claim 1, characterized in that the valve opening in the region of the sealing section is formed in a slit-like manner.

6. The delivery catheter as recited in claim 5, characterized in that the valve body section surrounding the valve opening is configured in an elliptical manner and that the valve opening in the region of the sealing section extends transverse to the insertion direction along the major axis of the elliptical valve body section.

7. The delivery catheter as recited in claim 5, characterized in that the taper and/or the extension has/have two first sections, which are mirror-symmetrical to a mirror plane extending in the insertion direction through the valve opening, and that the taper has two second sections extending semi-conically toward the corners of the slit-shaped valve opening.

8. The delivery catheter as recited in claim 1, characterized in that the valve body has a flange section for disposing the valve body at the delivery catheter.

9. The delivery catheter as recited in claim 8, characterized in that the valve body is mounted on an attachment section, wherein the flange section for configuring a plug connection has at least one mandrel or one recess, and the delivery catheter has at least one corresponding recess or one mandrel.

10. The delivery catheter as recited in claim 1, characterized in that the valve body is made from silicone having a Shore hardness A of 8-25, or comprises this material, and/or that the valve opening at least in the region of the sealing section is coated, wherein the coating comprises silicone oil.

11. The delivery catheter as recited in claim 1, characterized in that the outside of the valve body has at least one valve groove for forming a predetermined breaking point.

12. The delivery catheter as recited in claim 10, characterized in that the outside of the valve body has at least one delivery catheter groove located in the same plane as the valve groove to form a predetermined breaking point, wherein the delivery catheter groove together with the delivery catheter is produced by way of extrusion or injection molding.

13. A valve body for a delivery catheter comprising a valve body having a closeable valve opening for introducing a medical device in insertion direction into, in particular, a blood vessel, characterized in that the valve body is formed in one piece, and that the valve opening, when a medical device is not introduced, tapers in the insertion direction, and a sealing section, which in a closed position at least in sections is subject to a pretension, directly adjoins the taper, so that the sealing section when a medical device is introduced is actuated from the closed position into an open position in such manner that the sealing section encloses the medical device in a substantially fluid-tight manner, wherein the valve opening tapers in the insertion direction in an arcuate or wave-like or linear manner toward the sealing section and starting from the sealing section expands in the insertion direction in an arcuate or wave-like manner, and wherein the taper and the extension are mirror-symmetrical to a mirror plane extending along the insertion direction through the valve opening.

14. A delivery catheter-dilator assembly, comprising a delivery catheter comprising a valve body having a closeable valve opening for introducing a medical device in insertion direction into, in particular, a blood vessel, characterized in that the valve body is formed in one piece, and that the valve opening, when a medical device is not introduced, tapers in the insertion direction, and a sealing section, which in a closed position at least in sections is subject to a pretension, directly adjoins the taper, so that the sealing section when a medical device is introduced is actuated from the closed position into an open position in such manner that the sealing section encloses the medical device in a substantially fluid-tight manner, wherein the valve opening tapers in the insertion direction in an arcuate or wave-like or linear manner toward the sealing section and starting from the sealing section expands in the insertion direction in an arcuate or wave-like manner, and wherein the taper and the extension are mirror-symmetrical to a mirror plane extending along the insertion direction through the valve opening, and a dilator disposed at the delivery catheter, wherein the dilator in sections extends through the delivery catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In the figures,

[0030] FIG. 1 shows a schematic side view of a delivery catheter-dilator assembly;

[0031] FIG. 2 shows a schematic side view of the catheter of the assembly according to FIG. 1;

[0032] FIG. 3 shows a schematic side view of the dilator of the assembly according to FIG. 1;

[0033] FIG. 4 shows an exploded view of the delivery catheter according to FIG. 2;

[0034] FIG. 5 shows a perspective view of the valve body of the delivery catheter according to FIG. 4;

[0035] FIG. 6 shows a bottom view of the valve body according to FIG. 5;

[0036] FIG. 7 shows a perspective view of a longitudinal section along line C-C of the valve body according to FIG. 6;

[0037] FIG. 8 shows a longitudinal section along line A-A according to FIG. 6;

[0038] FIG. 9 shows a cross section along line B-B according to FIG. 6;

[0039] FIG. 10 shows a longitudinal section along line A-A according to FIG. 6 according to a second embodiment;

[0040] FIG. 11 shows a cross section along line B-B according to FIG. 6 according to a second embodiment; and

[0041] FIG. 12 shows a longitudinal section along line C-C according to FIG. 6 according to a third embodiment.

DETAILED DESCRIPTION

[0042] FIG. 1 shows a delivery catheter dilator assembly denoted in total with reference character 2, including a delivery catheter 4 and a dilator 6 situated thereon. In this instance, delivery catheter 4 has a tube section 8 and a head section 10 (cf. FIG. 2). Dilator 6 also has a tube section 11 and a head section 12 (cf. FIG. 3). Tube section 11 of the dilator extends in this instance through tube section 8 of delivery catheter 4, tip 5 of dilator 6 projecting out of the delivery catheter.

[0043] As can be clearly seen from FIG. 4, head section 10 of delivery catheter 4 has an attachment section 14. Attachment section 14 includes a plurality of mandrels 16. A valve body 18 is situated at this attachment section 14. For this purpose, valve body 18 has a flange section 20 having a plurality of recesses 22, which correspond with mandrels 16 so that valve body 18 is pluggable by way of a plug connection onto attachment section 14.

[0044] Furthermore, outside 24 of attachment section 10 has a plurality of protrusions 26. Two holding parts 28, 30 are clippable to these protrusions. In turn, holding parts 28, 30 each have one locking means 32, 34, into which locking hooks 37, 38 provided at attachment section 12 of dilator 6 can latch, as it can be seen in FIG. 1.

[0045] As can be concluded from FIGS. 5 to 9, valve body 18 has a closeable valve opening 36, which extends from a top side 37 to a bottom side 39 of valve body 18. In this instance, valve opening 36 tapers in insertion direction 40. A sealing section 44 directly adjoins this taper 42 in insertion direction 40. For this purpose, sealing section 44 is located in the center region of valve opening 36. In turn, an extension 46 directly adjoins sealing section 44 in insertion direction 40.

[0046] In this instance, valve opening 36 expands into extension 46 in insertion direction 40 to the same extent as valve opening 36 tapers into taper 42. Consequently, valve opening 36 is mirror-symmetrical in relation to a mirror plane 48 extending transverse to insertion direction 40 through sealing section 44.

[0047] Moreover, valve opening 36 or entire valve body 18 is mirror-symmetrical in relation to a mirror plane 52 extending along insertion direction 40 through valve opening 36. In this instance, mirror plane 52 extends moreover along slit-shaped valve opening section 54 limited by sealing section 44, as it is shown in FIG. 9.

[0048] Valve body section 50 adjoining flange section 20 in insertion direction 40 (cf. FIGS. 8 and 9) is elliptically formed. For this purpose, slit-shaped valve opening section 54 in the region of sealing section 44 extends transverse to insertion direction 40 along the major axis of this elliptical valve body section 50.

[0049] Taper 42 and extension 46 each have two first sections 56, 58, 60, 62, which are mirror-symmetrical to mirror plane 52, and which have the same transverse extent as slit-shaped valve opening 54 (cf., in particular, FIGS. 10, 12). As can be concluded from FIGS. 9, 10 and 12, respectively two second sections 64, 66, 68, 70 directly adjoin first sections 56, 58, 60, 62, which are formed semi-conically and extend toward corners 72, 74 (cf. FIG. 6) of slit-shaped valve opening section 54.

[0050] First sections 56, 58, 60, 62 taper or expand in this instance, according to FIGS. 7 through 9 in a linear manner, according to FIGS. 10 and 11 in a concave arcuate manner and according to FIG. 12 in a waved manner having convex and concave sections. In particular, the waved configuration according to FIG. 12 offers certain advantages concerning the friction when introducing a medical device through valve opening 36.

[0051] As it is shown in FIGS. 9 and 10, sealing section 44 in insertion direction 40 has a length d, while taper 42 has a length e and extension 46 has a length f. For this purpose, e=f and e/d equals approximately 2. The ratio e/d generally can be between 1 and 10. According to FIG. 7, valve opening 36 tapers in slit direction 43 from a length a to a length b, ratio a/b being approximately 2. The ratio a/b generally can be between 1.1 and 10.

[0052] As it is in particular shown in FIG. 5, two valve grooves 76, 78 for forming a predetermined breaking point are provided on the outside of valve body 18. In the same plane as these valve grooves 76, 78, delivery catheter grooves 80, 82 are provided, which also represent such a predetermined breaking point (cf. FIG. 4). For this purpose, delivery catheter grooves 80, 82 are introduced during extruding or injection molding of delivery catheter 4 and do not have to be introduced by way of a separate production step.

[0053] After a medical device, in particular a catheter, has been introduced through delivery catheter 4 into a blood vessel, catheter 4 can be removed as follows: Head section 10 of catheter 4 has two wings 84, 86. An operator can pull on these wings 84, 86. Then, valve 18 and delivery catheter 4 are broken open in a zipper-like manner and are pulled away from the blood vessel.

[0054] For this purpose, valve body 18 is made from silicone having a Shore hardness A between 8-25. Moreover, the valve opening is coated in the region of the sealing section. The coating, in particular, can be made from silicone oil.

[0055] If valve body 18 is situated at catheter 4, sealing section 44 is subject to a pretension. This is because elliptical valve body section 50 in the non-disposed state projects beyond receptacle 88 indicated in FIG. 4 along the complete circumference by approximately 0.2 mm. In the disposed state, the elliptical valve body section is consequently compressed so that a pressure force and, for this reason, a pretension act upon sealing section 44. To facilitate the situating of valve body section 18 at attachment section 50, the valve body section tapers slightly in insertion direction 40, as can be seen from FIG. 8. When disposing valve body 18 at attachment section 14, valve body section 50 is consequently subjected to a pressure force, which results in that sealing section 44 assumes a closed position so that valve body 18 is closed in a fluid-tight manner. If a medical device is, for example a catheter having a releasable stent disposed thereon, introduced into a blood vessel in insertion direction 40 through valve opening 36, sealing section 44 is indeed pressed and, for this reason, actuated into the open position. Owing to the pretension acting upon sealing section 44, the medical device is however enclosed in a fluid-tight manner. This is regardless of whether the medical device has a round, oval or similar cross section, and regardless of the size of the cross section. In this instance, pressure forces act in particular perpendicular to the extent of slit-shaped valve opening section 54 in the region of sealing section 44.

[0056] To produce delivery catheter-dilator assembly 2, first valve body 18 is disposed at attachment section 14 of delivery catheter 4. Then, holding parts 28, 30 are disposed at delivery catheter 4. Finally, tube section 10 of the dilator is guided through tube section 8 of the catheter and dilator 6 is attached at delivery catheter 4.

[0057] Situating this delivery catheter-dilator assembly 2 in a blood vessel can be carried out by way of the Seldinger method. For this purpose, first a vein or artery is opened by a needle and then a guide wire is introduced through the lumen of the needle into the vein or artery. The needle is then withdrawn and delivery catheter-dilator assembly 2 is introduced along the guide wire into the blood vessel. Then, dilator 6 is removed from delivery catheter 4. Subsequently, a medical device, for example a catheter, is introduced in a fluid-tight manner through valve body 18 of delivery catheter 4 into the blood vessel. Thereafter, delivery catheter 4 is pulled apart in a zipper-like manner by pulling on wings 84, 86 and, in so doing, is removed.