WO2025133667A1

WO2025133667A1 - Syringe adapter for fixation in rotation axis

Info

Publication number: WO2025133667A1
Application number: PCT/IB2023/000767
Authority: WO
Inventors: Nicolas Shan; Patrick LE GOUSSE
Original assignee: Sorin CRM SAS
Current assignee: Sorin CRM SAS
Priority date: 2023-12-18
Filing date: 2023-12-18
Publication date: 2025-06-26
Anticipated expiration: 2026-06-18

Abstract

The present invention relates to a coupling device and placement method for connecting a syringe to a proximal connector (e.g., hub) of a catheter to allow injection of a liquid (e.g., a contract agent) and rotation of the catheter by the syringe. The coupling device is configured to allow fixation of the syringe at the proximal end of the catheter in the axis of rotation of the catheter and comprises an insertion portion for inserting of a medical device/instrument into the catheter and an outlet portion for guiding a liquid tube from an ejection outlet of the syringe to the proximal connector of the catheter.

Description

SYRINGE ADAPTER FOR FIXATION IN ROTATION AXIS

Field

The present application relates to systems and apparatus for positioning medical (implantable or non-implantable) devices/instruments and for delivering media within a body of a patient.

Background

Various types of catheters and associated methods for delivery of medical devices/instruments to target sites within a patient's body are known in the art. A properly positioned catheter can provide a convenient conduit for an operator/clinician to pass an elongate medical device, such as a medical electrical lead, into the body to deliver a sitespecific therapy from the device.

Catheter delivery systems may comprise a catheter, a sealing assembly, a syringe, and an insertion accessory tool to assist in inserting devices/instruments, such as guide wires, a medical electrical lead and a sub-selecting catheter, into the catheter. The catheter comprises a "hub" that refers to the proximal connector end of the catheter and connects to blood lines or a "cap" that refers to a device that screws on to and occludes the hub. Furthermore, a so-called "limb" refers to a catheter portion that extends from the patient's body to the hub.

In examples, the sealing assembly may be connected to the catheter by inserting a distal end of the sealing assembly into the hub of the catheter, and, once connected, a valve/seal member (e.g., as described in US 5 125 904 A, US 5 312 355 A or US 5 409 463 A), which may be located within a body of the sealing assembly (e.g., in proximity to a proximal end thereof) may both seal off a lumen of the catheter and provide a passageway into the lumen. The passageway into the lumen of catheter is intended to allow passage of a medical device (e.g., a medical electrical lead) therethrough, so that an operator may deliver the medical device through the lumen of catheter to a target site within a body of the patient.

Additionally, a passageway for injection of a liquid from the syringe into the lumen of the catheter may be provided. The liquid may be a saline flush or a radiopaque contrast agent that is useful for visualizing anatomy (e.g., a venous anatomy on fluoroscopy) downstream of the distal end of the catheter and thereby facilitating positioning of the distal end, the guidewire and/or the medical device at or in proximity to the target site.

Fig. 2 schematically shows a perspective view of a conventional catheter delivery system where a syringe 30 is connected via a tube 34 to a hub 24 provided at a proximal connector end 20 of a catheter 10. A hub cap 22 can be screwed (or glued or force-fitted with some kind of protrusion) on the hub 24 to occlude an opening 26 for inserting a medical device/instrument into a corresponding lumen of the catheter 10.

The syringe 30 is operated via a plunger 36 to press liquid (e.g., contrast agent) contained in a barrel of the syringe 30 through a check valve 32 (e.g., a one-way valve that prevents backflow) at an ejection outlet of the syringe 30 and through the tube 34 and the hub 24 into a corresponding lumen in the catheter 10.

During implantation, a physician or other user may need to rotate the catheter 10 (e.g., via the hub 24) to find the entrance of a vessel (e.g., the coronary vein). For a better visibility of the position under x-ray equipment, he/she injects x-ray contrast agent liquid with the syringe 30 through the check valve 32.

However, one physician or other user alone has difficulty to inject the x-ray contrast media via the syringe while rotating the catheter for positioning the distal end, the guidewire and/or the medical device at or in proximity to the target site and/or inserting a medical device/instrument through the opening 26 of the hub 24. Therefore, two people are typically required.

Summary

It is an object of the present invention to facilitate the combined actions of injecting liquid and inserting medical devices/instruments to the target site.

This object is achieved by a coupling device as claimed in claim 1 and by a method as claimed in claim 15.

According to a first aspect, a coupling device is provided for coupling a proximal connector end of a catheter to a syringe, the coupling device comprising: a distal coupling portion configured to establish a first releasable connection to the proximal connector end of the catheter; a proximal coupling portion configured to establish a second releasable connection to an ejection outlet of the syringe; an insertion portion configured to allow insertion of a guide wire or lead into the catheter through the distal coupling portion and the proximal connector end; and an outlet portion configured to guide a liquid tube connected through the proximal coupling portion to the ejection outlet of the syringe to the proximal connector end of the catheter

According to a second aspect, a method of placing a guide wire or lead via a catheter into a target area within a body of a patient is provided, wherein the method comprises: establishing a first releasable connection to a proximal connector end of the catheter by using a distal coupling portion of a coupling device; establishing a second releasable connection to an ejection outlet of a syringe by using a proximal coupling portion of the coupling device; guiding a liquid tube from an ejection outlet of the syringe through the proximal coupling portion and an outlet portion of the coupling device to the proximal connector end of the catheter; and inserting the guide wire or lead through an insertion portion of the coupling device and the distal coupling portion and the proximal connector end into the catheter.

Accordingly, a physician or other user is enabled to connect or fix the syringe (which may be used to inject an x-ray contrast agent liquid) on/to a hub of the catheter in the axis of rotation. Thereby, insertion of the guide wire or lead and injection of the liquid into the catheter can be done by a single person holding the syringe with the connected hub in one hand and inserting the guide wire or lead with the other hand.

According to a first option that can be combined with the above first or second aspects, the coupling device may comprise a body portion between the distal coupling portion and the proximal coupling portion, that is adapted to provide a portion of a guiding path for the guide wire or lead and/or the liquid tube via the connector end into at least one lumen of the catheter. According to a second option that can be combined with the first option or the above first or second aspect, the coupling device may comprise one or more grooves or ridges or other blocking surface structures at the proximal coupling portion and/or the distal coupling portion of the coupling device to prevent rotation of the syringe and/or the proximal connector end relative to the coupling device.

According to a third option that can be combined with the above first or second aspect, the proximal coupling portion may comprise a threaded portion to allow screwing a tip of the syringe (e.g., a luer lock syringe) on or into the proximal coupling portion to thereby fix the syringe at the coupling device.

According to a fourth option that can be combined with the third option or the above first or second aspect, the proximal coupling portion may comprise a cavity in which a check valve with the threaded portion is accommodated for screwing the tip of the syringe onto the check valve.

According to a fifth option that can be combined with the fourth option or the above first or second aspect, the check valve may comprise a radially extending fin-like protrusion that interacts with a matched slit or groove of the coupling device to block a rotation between the coupling device and the check valve.

According to a sixth option that can be combined with the fourth or fifth option or the above first or second aspect, the proximal coupling portion may be configured as a cylindrical element with an opening slit along an axial direction to provide a flexible diameter for clamping the proximal coupling portion on the check valve or the tip of the syringe.

According to a seventh option that can be combined with any one of the first to sixth options or the above first or second aspect, the coupling device may further comprise a pair of clamps to allow clipping the distal coupling portion of the coupling device on the proximal connector end of the catheter.

According to an eighth option that can be combined with the seventh option or the above first or aspect, the distal coupling portion may be configured to increase an inner diameter of a cavity portion of the distal coupling portion when the clamps are pressed together to allow putting the cavity portion of the distal coupling portion over a cap of a hub of the proximal connector end or releasing it therefrom. According to a ninth option that can be combined with the seventh or eighth option or the above first or second aspect, the coupling device may further comprise one or more guiding grooves on an upper side of the distal coupling portion, configured to allow insertion of guiding rails provided on the proximal connector end of the catheter into the grooves to insert the cap of the proximal connector end of the catheter into the distal coupling portion until it clicks into place.

According to a tenth option that can be combined with the seventh option or the above first or second aspect, the pair of clamps may comprise hook-like portions inclined towards a distal direction to slide over a hub of the proximal connector end of the catheter and snap together to fix the distal coupling portion at the hub.

According to an eleventh option that can be combined with any one of the first to tenth options or the above first or second aspect, the coupling device may further comprise an insertion tool (e.g., transvalvular insertion tool (TVI) or "tunnel shoehorn") which is configured to facilitate the insertion of the guide wire or lead into the insertion portion of the coupling device.

According to a twelfth option that can be combined with the above first or second aspect, the proximal coupling portion and the distal coupling portion may be configured as U-shaped or open circular structures that provide a clamping function for respectively clamping the proximal coupling portion to a check valve of the syringe and the distal coupling portion to the cap of the hub of the proximal connector end of the catheter to fix them together, wherein the insertion portion for the guide wire or lead is configured as a central axial opening of the distal coupling portion, and wherein the outlet portion for the liquid tube is configured as a lateral opening in the distal coupling portion.

According to a thirteenth option that can be combined with the above first or second aspect, the coupling device may further comprise a central cylindrical portion for inserting or screwing a check valve or a tip of the syringe at the proximal end, wherein the cylindrical portion comprises a tapered portion at the distal end configured to guide the guide wire or lead into the proximal connector end of the catheter. This option (e.g., as shown in Fig.13) can be used to help a physician to rotate (in the axis) the catheter during the injection of the x-ray liquid without inserting a guide wire or lead. Brief Description of the Drawings

To assist understanding of the present disclosure and to show how embodiments may be put into effect, reference is made by way of example to the accompanying drawings in which:

Fig. 1 schematically shows a side view of a coupling device according to various embodiments for connecting a syringe to a catheter;

Fig. 2 schematically shows a perspective view of a conventional system where a syringe is connected to a catheter hub via a tube;

Fig. 3 schematically shows a side view of a coupling device according to a first embodiment for connecting a syringe to a catheter;

Fig. 4 schematically shows a perspective view of the coupling device according to the first embodiment from the side of the syringe;

Figs. 5A and 5B schematically show perspective views of a lower side and an upper side, respectively, of the coupling device according to the first embodiment when separated from the syringe and the catheter;

Fig. 6 schematically shows a perspective view of the coupling device according to the first embodiment from the side of the catheter;

Fig. 7A schematically shows a perspective view of the coupling device according to the first embodiment from the side of the syringe with inserted lead;

Fig. 7B schematically shows a perspective top view of the coupling device according to the first embodiment with inserted lead;

Fig. 8 schematically shows a perspective view of the coupling device according to the first embodiment from the side of the syringe with inserted lead, insertion tool and detached syringe;

Fig. 9 schematically shows a perspective view of a coupling device according to a second embodiment when separated from the syringe and the catheter;

Fig. 10 schematically shows a perspective view of a coupling device according to a third embodiment when separated from the syringe and the catheter;

Fig. 11 schematically shows a perspective view of a coupling device according to a fourth embodiment when separated from the syringe and the catheter; Fig. 12 schematically shows a perspective view of a coupling device according to a fifth embodiment when separated from the syringe and the catheter;

Fig. 13 schematically shows a perspective view of a coupling device according to a sixth embodiment when separated from the syringe and the catheter;

Fig. 14 schematically shows a perspective view of a coupling device according to a seventh embodiment when separated from the syringe and the catheter; and

Fig. 15 schematically shows a cross-sectional view in the axial direction of a modification of a central cylindrical portion of the coupling device according to the seventh embodiment.

Detailed Description

In the following, embodiments of the present invention are described in more detail based on a coupling device (e.g., coupling/adapter tool) which enables a physician or other user to connect or fix a syringe (which may be used to inject an x-ray contrast agent liquid) on/to a hub of a catheter in the axis of rotation. Thereby, insertion of the medical device/instrument (e.g., guide wire, pacing lead etc.) and injection of the liquid into the catheter can be done by a single person holding the syringe with the connected hub in one hand and inserting the medical device/instrument with the other hand.

Throughout the present disclosure, "proximal" and "distal" are terms that are used to indicate distances from an operating end (reference point) of the lead device, where the physician or other user controls the screwing process. Proximal is closer to the operating end, while distal is further away (at a greater distance) from the operating end.

It is noted that throughout the present disclosure only those blocks, components and/or devices that are relevant for the proposed data distribution function are shown in the accompanying drawings. Other blocks, components or devices may have been omitted for reasons of brevity. Furthermore, blocks, components or devices designated by same reference numbers are intended to have the same or at least a similar function, so that their function is not described again later.

Fig. 1 schematically shows a side view of a coupling device 40 according to various embodiments for connecting a syringe 30 to a catheter 10. As can be gathered from Fig. 1, the coupling device 40 is configured to allow fixation of the syringe 30 at the proximal end of the catheter 10 in the axis of rotation of the catheter 10, so that the catheter 10 can be rotated or otherwise moved by the physician or other user while operating the syringe 30.

The coupling device 40 (e.g., adapter or coupling tool/element) comprises a distal coupling portion 42 with a thread or clip or other releasable fixation mechanism, adapted to connect to a proximal connector end 20 of the catheter 10, a body portion 41 adapted to guide a medical device/instrument 50 (e.g., a pacing lead or guide wire) and a tube 34 of the syringe 30 via respective guiding portions 46, 48 (e.g., channels, tubes, holes, grooves etc., as indicated by the dotted lines) through the connector end 20 into at least one lumen (as indicated dashed lines) of the catheter 10, and a proximal coupling portion, adapted to connect to an ejection outlet of the syringe 30 with a check valve 32.

The syringe 30 may comprise a plunger that controls ejection of a substance (e.g., contrast agent) contained in a barrel of the syringe 30 via the check valve 32 and the tube 34.

The guiding portions comprise an insertion portion 48 for providing an insertion guiding path for the medical device/instrument 50 into the connector end 20 of the catheter 10 and an outlet portion 46 for providing an outlet guiding path for the tube 34 from the check valve 32 of the syringe 30 to the connector end 20 of the catheter 10.

In an example, the proximal coupling portion 44 of the coupling device 40 may be configured (e.g., by a matched cavity portion or hole) to allow insertion and/or accommodation of the check valve 32 of the syringe 30.

Furthermore, one or more grooves or ridges or other blocking surface structures may be provided at the proximal coupling portion 44 of the coupling device 40 to prevent rotation of the syringe 30 relative to the coupling device 40.

Alternatively or additionally, the distal coupling portion 42 of the coupling device 40 may comprise one or more grooves or ridges or other blocking surface structures to prevent rotation of the connector end 20 of the catheter 10 relative to the coupling device 40.

In another example, the syringe 30 may be a luer lock syringe with a threaded tip that securely locks to the proximal coupling portion 44 of the coupling device 40 while ensuring a tight, leak-proof connection between the syringe 30 and the coupling device 40. Such luer lock syringes have a standardized connection system, making them compatible with various medical devices, such as needles, catheters, and infusion sets. This standardization allows for interchangeability and easy connection between different components.

Fig. 3 schematically shows a side view of a more detailed practical implementation of a coupling device 40 according to a first embodiment for connecting a syringe 30 to a catheter 10.

Here, the coupling device 40 has a pair of manually operable clamps 45 (or paddles or other flexible feature) to allow clipping the distal coupling portion 42 of the coupling device 40 on the cap of a hub 24 of the proximal connector end 20 of the catheter 10. When the clamps 45 are pressed together between two fingers of the physician or other user, the inner diameter of a cavity portion of the distal coupling portion 42 increases to allow putting the cavity portion of the distal coupling portion 42 over the cap of the hub 24 or releasing it therefrom.

The hub 24 may be made as a flexible (soft) part (handle) of the proximal connector end 20 of the catheter 10.

The proximal coupling portion 44 of the coupling device may be threaded to allow screwing the tip of the syringe (e.g., a luer lock syringe) with the check valve (not shown) into the proximal coupling portion 44.

As described later in more detail, a tube connected to the tip of the syringe 30 is routed through a guiding path within the coupling device 40 to an outlet portion of the coupling device 40 and from there via an inlet portion of the hub 24 into an inner lumen of the catheter 10.

Additionally, the coupling device 40 comprises an insertion portion for inserting a lead 50 into an inner lumen of the catheter 10.

It is noted that the lead 50 and the liquid from the syringe 30 may be in- serted/injected into the same inner lumen or different inner lumens of the catheter 10.

The lead 50 may comprise a proximal connector and an electrical conductor disposed within a lumen within the body of the lead 50 and extending from a proximal connector pin to a distal helix to provide both a physical connection and, in some embodiments, an electrical connection between the connector pin and an electrode at the helix. The conductor may be at least partly in the form of a coil within the lead 50. The connector pin may rotate freely relative to the proximal connector and the body of the lead 50 to transmit torque to the helix via the conductor.

In some embodiments, the body of the lead 50 may be a tubular structure including one or more lumens. The distal end may include at least one electrode and a helix electrode. The electrodes may be employed to electrically couple the lead 50 with a patient's heart (not shown). The helix may also be used to electrically couple the lead 50 with the heart.

In an example, the lead 50 may be a pacemaker or defibrillator lead that connects the myocardial site of sensing or stimulation with the respective cardiac electronic devices or other medical devices.

In another example, the lead 50 may be used in connection with a neurostimulator and may be implanted in the brain of a patient by jugular vein access.

The proximal connector of the lead 50 may be based on the industry standards IS1 and DF1 to ensure interchangeability of generators and leads from different manufacturers, thus allowing the device system to be tailored to the individual patient's needs. The lead 50 may possess a bifurcation (single-coil lead; one IS1, one DF1) or a trifurcation (dual-coil leads; one IS1, two DF1) at its proximal connector end. Alternatively, the proximal connector of the lead 50 may be based on the standard ISO 27186.1 with four-pole connector system for cardiac rhythm management devices. Its specifications apply to both low-energy (IS4) and high-energy (DF4) leads and ensures that IS4/DF4 leads are compatible with future implanted devices. Therefore, different connector pins (e.g., IS1 and DF4 pins) of the proximal connector of the lead 50 may have different designs.

Fig. 4 schematically shows a perspective view of the practical implementation of the coupling device 40 according to the first embodiment.

Here, the structure of the distal coupling portion 42 of the coupling device 40 with the pair of clamps 45 can be better seen. The distal coupling portion 42 has a gap on the upper side to allow an increase of the inner diameter of the cavity portion of the distal coupling portion 42 when the clamps 45 are pressed together to put (impose) the cavity portion of the distal coupling portion 42 over the hub cap or releasing it therefrom. Figs. 5A and 5B schematically show perspective views of a lower side and an upper side, respectively, of the coupling device 40 according to the first embodiment when separated from the syringe and the catheter.

As can be gathered from Fig. 5A, the coupling device 40 comprises a first groove with an inclined bottom to guide the tube 34 towards the outlet portion 46 of the coupling device 40.

Furthermore, the proximal coupling portion 44 comprises a cavity in which a check valve 32 with a proximal thread is provided for screwing the syringe (not shown) onto the check valve 32 and thereby fixing the syringe at the coupling device 40.

As can be gathered from Fig. 5B, the coupling device 40 comprises a second groove with an inclined bottom to guide a lead (e.g., lead 50) from the insertion portion 48 of the proximal connector end 20 (not shown) of the catheter 10 (not shown).

Furthermore, the check valve 32 comprises a radially extending fin-like protrusion 49 that interacts with a matched slit or groove of the coupling device 40 to block a rotation between the coupling device 40 and the check valve 32. Thereby, the syringe 30 can be rotationally fixed to the coupling device 40.

Fig. 6 schematically shows a perspective view of the coupling device 40 according to the first embodiment from the side of the catheter 10, when connected to the syringe 30 and the proximal connector end 20 of the catheter 10.

As can be gathered from Fig. 6, a clip mechanism is provided between the distal coupling portion 42 of the coupling device 40, which is activated by the pair of clamps 45. The clip mechanism comprises a guiding structure with a pair of rails 202 on the upper side of the proximal connector end 20 and guiding grooves 422 on the upper side of the distal coupling portion 42. The rails 202 are inserted into the grooves 422 to insert the hub cap 22 of the proximal connector end 20 of the catheter 10 into a matching cavity of the distal coupling portion until the clip mechanism clicks into place (e.g., via an undercutting or groove or fin or the like).

Now, the proximal connector end (20) of the catheter is fixedly and releasably connected to the syringe via the coupling device 40 in the axis of rotation of the catheter 10 to allow handling of the catheter 10 by the physician or other user via the syringe 30. The lead 50 may now be inserted by one hand of the physician or other user into a lumen of the catheter 10 via the insertion portion 48 of the coupling device 40 while holding (and operating) the syringe 30 with the catheter 10 in the other hand.

Fig. 7A schematically shows a perspective view of the coupling device 40 according to the first embodiment from the side of the syringe 30 after insertion of the lead 50.

Fig. 7B schematically shows a perspective top view of the coupling device according to the first embodiment with inserted pacing lead.

As can be gathered from Figs. 7A and 7B, the lead 50 is guided through the insertion portion 48 into the proximal connection end 20 of the catheter 10.

Fig. 8 schematically shows a perspective view of the coupling device 40 according to the first embodiment from the side of the syringe 30 with inserted lead 50 and detached syringe (not shown).

In Fig. 8, an optional insertion tool 60 is shown, which is configured to further facilitate the insertion of the lead 50 into the insertion portion 48 of the coupling device 40.

In an example, the insertion tool 60 may be configured as a transvalvular insertion (TVI) tool (e.g., "tunnel shoehorn"), as described e.g. in WO 2013/163349 A2.

In the example of Fig. 8, the insertion tool 60 may comprise a longitudinally rigid sheath having a lumen (tunnel) to provide a substantially obstruction free path for insertion of the lead 50. The rigid sheath has a length selected to extend at least partially through the distal coupling portion 42 of the coupling device 40 without substantial deformation of the lumen of the rigid sheath. A handling tab extends from the sheath to provide a kind of shoehorn functionality when used for inserting the lead 50.

The insertion tool 60 may be configured as an accessory tool that can be removed after insertion of the lead 50 without any effect on the lead 50.

Fig. 9 schematically shows a perspective view of a coupling device according to a second embodiment when separated from the syringe 30 and the catheter 10.

In the second embodiment, the coupling device is simplified by configuring the proximal coupling portion 44 and the distal coupling portion 42 as U-shaped or open circular structures so that they provide a clamping function for respectively clamping the check valve 32 and the hup cap 22 of the proximal connector end 20 of the catheter 10 to fix them together. The functionality of the pair of clamps of the first embodiment is simplified by the pair of legs 42A, 42B of the U-shaped distal coupling portion.

Furthermore, the insertion portion 48 for the lead 50 is simplified by a central axial opening of the distal coupling portion and the outlet portion for the tube 34 is simplified by a lateral opening (slit) e.g. in a lower portion of the U-shaped distal coupling portion 42.

Additionally, a guide groove 90 is provided for guiding the tube 34 to the outlet portion 46.

Fig. 10 schematically shows a perspective view of a coupling device according to a third embodiment when separated from the syringe 30 and the catheter 10.

In the third embodiment, the coupling device is simplified by configuring the proximal coupling portion 44 as a cylindrical element with an opening slit along the axial direction to provide a flexible diameter for clamping the proximal coupling portion 44 on the check valve 32 or the tip of the syringe 30. The distal coupling portion with the clamping legs 42A and 42B is similar to the second embodiment.

Furthermore, as in the second embodiment, the insertion portion 48 for the lead 50 is simplified by central axial opening of the distal coupling portion and the outlet portion for the tube 34 is simplified by the lateral opening (slit) in the lower portion of the U-shaped distal coupling portion.

In the third embodiment, the guide groove 90 for guiding the tube 34 to the outlet portion 46 has a more cylindrical structure for increasing the stability and rigidity of the body portion of the coupling device.

Fig. 11 schematically shows a perspective view of a coupling device according to a fourth embodiment when separated from the syringe 30 and the catheter 10.

Similar to the third embodiment, the proximal coupling portion 44 is configured as a cylindrical element with an opening slit to provide a flexible diameter for clamping the check valve 32 or the tip of the syringe 30. The distal coupling portion 42 is also configured as a cylindrical element with an opening slit to provide a flexible diameter for clamping the hub cap 22 of the proximal connector end 20 of the catheter 10.

A pair of fin-like clamps clamping 45 protrudes from the distal coupling portion 42 for increasing the inner diameter of the distal coupling portion 42. Furthermore, the insertion portion 48 for the lead 50 comprises an inclined bottom for guiding the lead 50 towards the proximal connector end 20 of the catheter 10. The outlet portion (not shown) for the tube 34 may be simplified by a lateral opening (slit) in the lower portion of the cylindrical distal coupling portion 42.

In the fourth embodiment, the tube 34 is guided through the closed cylindrical body portion to the outlet portion. The closed cylindrical structure of the body portion of the coupling device provides for increased stability and rigidity of the coupling device.

Fig. 12 schematically shows a perspective view of a coupling device according to a fifth embodiment when separated from the syringe 30 and the catheter 10.

The fifth embodiment is similar to the fourth embodiment, with the difference that the pair of fin-like clamps 45 are now configured with respective hook-like portions inclined towards the distal direction to slide over the hub 24 and snap together to fix the distal coupling portion 42 at the hub 24 when the hub cap 22 is fully inserted in the cavity of the distal coupling portion 42.

Fig. 13 schematically shows a perspective view of a coupling device according to a sixth embodiment when separated from the syringe 30 and the catheter 10.

In the sixth embodiment, the coupling device is configured with a central cylindrical portion into with the check valve 32 or the tip of the syringe 30 is in- serted/screwed at the proximal end and which comprises a tapered portion 43 at the distal end through which the x-ray liquid from the syringe 30 can be injected into the lumen of the catheter 10 (not shown).

The sixth embodiment may be used to help a physician or other user to rotate (in the axis) the catheter during the injection of the x-ray liquid without inserting a guide wire or lead.

Fig. 14 schematically shows a perspective view of a coupling device according to a seventh embodiment when separated from the syringe and the catheter.

The seventh embodiment is derived from the concept of the above sixth embodiment with a central cylindrical portion which now comprises an upper groove portion that serves as the inserting portion 48 for inserting and guiding the guide wire or lead 50 into a respective lumen of the catheter 10 (not shown). Additionally, the cylindrical portion comprises a moon-shaped lumen for injecting x-ray liquid from the syringe 30 can be injected into another lumen of the catheter 10. Thereby, the physician or other user is enabled to inject the x-ray liquid with the guide wire or lead 50 in place. In this case, the use of a valve on the lead lumen may be useful if no lead is inserted.

Similar to the fifth embodiment, a pair of fin-like clamps 45 with respective hook-like portions may be provided so as to slide over the hub 24 and snap together to fix the distal end of the central cylindrical portion at/in the hub cap 22 of the hub 24.

Fig. 15 schematically shows a cross-sectional view in the axial direction of a further modification of the central cylindrical portion of the seventh embodiment, which now comprises two lumens. The moon-shaped lumen for injecting the x-ray liquid and circular lumen as the inserting portion 48 for inserting and guiding the guide wire or lead 50. Thereby, the size of the coupling device can be minimized.

The coupling device 40 of the above embodiments may be made of a thermoplastic of relative high durometer, such as a polycarbonate or acrylonitrile butadiene styrene (ABS) and/or it may be made of a thermoplastic, thermoset, or cast material with less hardness.

Furthermore, in at least some of the above embodiments, a funnel for supporting inserting of the lead 50 may be provided at the insertion portion 48. The funnel facilitates the insertion of the lead 50 into the insertion portion 48. Thereby, a physician or other user can be supported to guide the distal end of the lead 50 into the aperture. The funnel also prevents visual confusion so that the physician or other user will not hesitate to insert the distal end of the lead 50 into the aperture of the coupling device 40 by a forced axial movement, since the risk of breaking a connector pin and/or an inner pin connection is reduced.

The funnel may be provided as single- or multi-part element moulded or removably fixed (e.g., clipped) to the coupling device. The funnel may be fixed to the coupling device either during manufacturing/assembly of the coupling device 40 or during use by the physician or other user for increased flexibility of use (e.g., optional use, pin-dependent use etc.).

The physician or other user can manually rotate a rotatable connector pin that protrudes from a proximal connector of the inserted lead 50 to thereby extend a helix at the distal end of the lead 50 with moderate (over-)torque. Additionally, the physician may then screw the helix by rotating the connector itself. The surface of at least a portion of the connector pin and/or the connector may be structured with a polygonal pattern to allow engaging a dedicated butterfly tool or crocodile clamp or other handling tool with a mouth opening adapted to the polygonal pattern to operate the connector pin and/or connector of the inserted pacing lead.

Through the above embodiments, placing of medical devices or instruments (e.g., a leads or guide wires) via a catheter into a target area within the body of a patient with the help of e.g. a contrast agent (or other liquid) can be facilitated (e.g., performed by a single person) by establishing a first releasable connection to a proximal connector end of the catheter by using a distal coupling portion of a coupling device, establishing a second releasable connection to an ejection outlet of a syringe by using a proximal coupling portion of the coupling device, guiding a liquid tube from an ejection outlet of the syringe through the proximal coupling portion and an outlet portion of the coupling device to the proximal connector of the catheter, and inserting the guide wire or lead through an insertion portion of the coupling device and the distal coupling portion and the proximal connector into the catheter.

To summarize, a coupling device and placement method have been described, for connecting a syringe to a proximal connector (e.g., hub) of a catheter to allow injection of a liquid (e.g., a contract agent) and rotation of the catheter by the syringe. The coupling device is configured to allow fixation of the syringe at the proximal end of the catheter in the axis of rotation of the catheter and comprises an insertion portion for inserting of a medical de-vice/instrument into the catheter and an outlet portion for guiding a liquid tube from an ejection outlet of the syringe to the proximal connector of the catheter.

The embodiments and examples described herein are to be understood as illustrative examples of embodiments of the invention. The coupling device may be used for any type of catheter including navigatable catheters.

Any feature described in relation to any one example or embodiment may be used alone or in combination with other features. In addition, any feature described in relation to any one example or embodiment may also be used in combination with one or more features of any other of the examples or embodiments, or any combination of any other of the examples or embodiments. Furthermore, equivalents and modifications not described herein may also be employed within the scope of the invention as defined in the claims.

Claims

1. A coupling device (40) for coupling a proximal connector end (20) of a catheter (10) to a syringe (30), the coupling device (40) comprising: a distal coupling portion (42) configured to establish a first releasable connection to the proximal connector end (20) of the catheter (10); a proximal coupling portion (44) configured to establish a second releasable connection to an ejection outlet of the syringe (30); an insertion portion (48) configured to allow insertion of a guide wire or lead (50) into the catheter (10) through the distal coupling portion (42) and the proximal connector end (20); and an outlet portion (46) configured to guide a liquid tube (34) connected through the proximal coupling portion (44) to the ejection outlet of the syringe (30) to the proximal connector end (20) of the catheter (10).

2. The coupling device (40) of claim 1, further comprising a body portion (41) between the distal coupling portion (42) and the proximal coupling portion (44), adapted to provide a portion of a guiding path for the guide wire or lead (50) and/or the liquid tube (34) via the connector end (20) into at least one lumen of the catheter (10).

3. The coupling device (40) of claim 1 or 2, further comprising one or more grooves or ridges or other blocking surface structures at the proximal coupling portion (44) and/or the distal coupling portion (42) of the coupling device (40) to prevent rotation of the syringe (30) and/or the proximal connector end (20) relative to the coupling device (40).

4. The coupling device (40) of any one of claims 1 to 3, wherein the proximal coupling portion (44) comprises a threaded portion to allow screwing a tip of the syringe (30), particularly a luer lock syringe, on or into the proximal coupling portion (44) to thereby fix the syringe (30) at the coupling device 40.

5. The coupling device (40) of claim 4, wherein the proximal coupling portion (44) comprises a cavity in which a check valve (32) with the threaded portion is accommodated for screwing the tip of the syringe (30) onto the check valve (32).

6. The coupling device (40) of claim 6, wherein the check valve (32) comprises a radially extending fin-like protrusion (49) that interacts with a matched slit or groove of the coupling device (40) to block a rotation between the coupling device (40) and the check valve (32).

7. The coupling device (40) of claim 5 or 6, wherein the proximal coupling portion (44) is configured as a cylindrical element with an opening slit along an axial direction to provide a flexible diameter for clamping the proximal coupling portion (44) on the check valve (32) or the tip of the syringe (30).

8 The coupling device (40) of any one of the preceding claims, further comprises a pair of clamps (45) to allow clipping the distal coupling portion (42) of the coupling device (40) on the proximal connector end (20) of the catheter (10).

9. The coupling device (40) of claim 8, wherein the distal coupling portion (42) is configured to increase an inner diameter of a cavity portion of the distal coupling portion (42) when the clamps (45) are pressed together to allow putting the cavity portion of the distal coupling portion (42) over a cap (22) of a hub (24) of the proximal connector end (10) or releasing it therefrom.

10. The coupling device (40) of claim 8 or 9, further comprising one or more guiding grooves (422) on an upper side of the distal coupling portion (42), configured to allow insertion of guiding rails (202) provided on the proximal connector end (20) of the catheter (10) into the grooves (422) to insert the cap (22) of the proximal connector end (20) of the catheter (10) into the distal coupling portion (42) until it clicks into place.

11. The coupling device (40) of claim 8, wherein the pair of clamps (45) comprise hook-like portions inclined towards a distal direction to slide over a hub (24) of the proximal connector end (20) of the catheter (10) and snap together to fix the distal coupling portion (42) at the hub (24).

12. The coupling device (40) of any one of the preceding claims, further comprising an insertion tool (60), particularly a tunnel shoehorn, which is configured to facilitate the insertion of the guide wire or lead (50) into the insertion portion (48) of the coupling device (40).

13. The coupling device (40) of claim 1, wherein the proximal coupling portion (44) and the distal coupling portion (42) are configured as U-shaped or open circular structures that provide a clamping function for respectively clamping the proximal coupling portion (44) to a check valve (32) of the syringe (30) and the distal coupling portion (42) to a cap (22) of a hub (24) of the proximal connector end (20) of the catheter (10) to fix them together, wherein the insertion portion (48) for the guide wire or lead (50) is configured as a central axial opening of the distal coupling portion (42), and wherein the outlet portion (46) for the liquid tube (34) is configured as a lateral opening in the distal coupling portion (42).

14. The coupling device (40) of claim 1, further comprising a central cylindrical portion for inserting or screwing a check valve (32) or a tip of the syringe (30) at a proximal end, wherein the cylindrical portion comprises a tapered portion (43) at a distal end.

15. A method of placing a guide wire or lead (50) via a catheter into a target area within a body of a patient, said method comprising: establishing a first releasable connection to a proximal connector end (20) of the catheter (10) by using a distal coupling portion (42) of a coupling device (40); establishing a second releasable connection to an ejection outlet of a syringe (30) by using a proximal coupling portion (44) of the coupling device; guiding a liquid tube (34) from an ejection outlet of the syringe (30) through the proximal coupling portion (44) and an outlet portion (46) of the coupling device (40) to the proximal connector end (20) of the catheter (10); and inserting the guide wire or lead (50) through an insertion portion (48) of the coupling device (40) and the distal coupling portion (42) and the proximal connector end (20) into the catheter (10).