Coupling for a medical delivery device

The present disclosure relates to a coupling, in particular a hub (2 a-i), with a base body (23 a-i) having a proximal end (24 a-i), embodied as a connecting region (25 a-i) for an applicator (26 a-i), and a distal end (27 a-i), embodied as connecting region (28 a-i) for a delivery device (29 a-i) with a tubular member (30 a-i) for delivering a medical device (31 a-1) into a part of an animal or human body, and having a recess (9 a-i) extending between the proximal end (24 a-i) and the distal end (27 a-i). It is provided that the recess (9 a-i) is positioned eccentrically from an outer diameter (20 a-i) of the base body (23 a-i) and a central axis (18 a-i) of the recess (9 a-i) is nonparallel in respect to a central axis (32 a-i) of the outer diameter (20 a-i) of the base body (23 a-i).

FIELD OF THE INVENTION

The present disclosure relates to a coupling for a medical delivery device and, more particularly, to a coupling for a medical delivery device having improved slittability.

BACKGROUND OF THE INVENTION

When performing vascular procedures, it may be desirable to deliver diagnostic and/or therapeutic agents into the body. It may be further desirable to deliver such agents while manipulating the position of a delivery device within the body. For example, in the setting of cardiac lead delivery, it may be desirable to simultaneously infuse radiocontrast through a delivery sheath while manipulating the sheath within the chambers of the heart. It may be further desirable to subsequently deliver a pacing lead to the heart through the delivery sheath and then remove the delivery sheath to leave the pacing lead in place. As a specific example, a delivery sheath may be introduced into the right atrium of the heart. The position of the delivery sheath within the heart may be manipulated and radiocontrast infused in order to identify and/or cannulate the coronary sinus. Subsequently, the position of the delivery sheath within the coronary sinus may be manipulated and radiocontrast infused in order to identify and/or cannulate a coronary venous tributary to the coronary sinus. Subsequently, a left ventricular pacing lead may be delivered to the venous tributary through the delivery sheath, after which the delivery sheath may be split or slit and than removed leaving the pacing lead in place. Such delivery devices are known, for example, from U.S. Pat. No. 6,159,198 and U.S. Publication No. 2007/0293845, the disclosures of which are hereby incorporated by reference herein.

A problem that arises is that the devices could have problems with easy slittability or splittability of the delivery device due to constructive properties of the device.

A problem addressed by this patent application is that of creating a coupling for a delivery device which has a slitting side with an improved slittability.

The present invention is directed toward overcoming one or more of the above-identified problems.

SUMMARY OF THE INVENTION

The problem according to the present disclosure is solved by the features of claim1. Favorable embodiments and advantages of the present disclosure result from the further claims, the drawings, and the description.

The present disclosure is directed to a coupling, in particular a hub, with a base body having a proximal end, embodied as a connecting region for an applicator, and a distal end, embodied as connecting region for a delivery device with a tubular member for delivering a medical device into a part of an animal or human body, and having a recess located/extending between the proximal end and the distal end.

It is provided that the recess is positioned eccentrically from an outer diameter of the base body and a central axis of the recess is nonparallel with respect to a central axis of the outer diameter of the base body. The embodiment according to the present disclosure provides a coupling which could be easily removed after placement of the medical device at an implantation site. Furthermore, the coupling could be constructed robustly and thus reliable.

A “coupling” as used herein is intended to mean, in particular, a structure by which at least two components of an apparatus can be connected, wherein the apparatus is intended for delivering and/or extracting an implant, an instrument, a medical device and/or an agent during a medical procedure, like, for example, a vascular procedure, into or from an animal's and/or human's body part, cavity, recess, vessel, organ, and/or other lumen, like, for example, a gastrointestinal tract, a urogenital tract, a reproductive tract, a respiratory tract, a lymphatic system, and particularly a vasculature. The coupling process could be irreversible or preferably reversible. Moreover, the connection of the coupling with a component of the apparatus could be performed by any suitable connecting process by, for example, an adhesive bond, a friction fit, a snap fit, a form and/or force closure, like glueing, welding, crimping, screwing, knotting and/or any other process being feasible for a person skilled in the art.

In this context, a “component” as used herein is intended to mean, in particular, an applicator, like an adapter, a syringe, a medical tube or a valve, or a delivery device, like a delivery shaft, a guide catheter, and/or other tubular member, to deliver a medical device, like a lead, a catheter and/or an electrode to a target location. However, any other component that appears reasonable to a person skilled in the art would also be feasible and is considered within the spirit and scope of the present invention.

Further, a “tubular member” as used herein is intended to mean, particularly, a structure with at least one tube.

Furthermore, a “base body” as used herein in this context is intended to mean, in particular, a structure that substantially imparts a shape and/or form of the coupling. It is preferably manufactured out of plastic, but other materials are also contemplated. Basically, it would also be feasible, however, for the base body to be composed at least partially of a biodegradable material.

In this context, a “proximal end” as used herein is intended to mean, in particular, an end of the coupling or the base body, respectively, which, in the state of the medical procedure, is oriented towards an operator.

Thus, a “distal end” as used herein is intended to mean, in particular, an end of the coupling or the base body, respectively, which, in the state of the medical procedure, is oriented away from the operator and/or toward the part of the animal's and/or human's body where the medical procedure takes place.

In this case, a “connecting region” as used herein defines, in particular, a region, where a connection with another component takes, took or can take place and/or which has or where at least a connecting means, like, for example, an electrical connector, a screw, a recesses, a groove, a ridge, a detent, a lug, a protrusion, a thread and/or any other means which is feasible for a person skilled in the art, is located and/or formed. Preferably, the connecting region is adapted to accept a male Luer fitting.

Furthermore, a “recess” as used herein in this context is intended to mean, in particular, a cavity, a hole and/or, in particular, a through hole.

The phrase “extending between the proximal end and the distal end” as used herein is intended to mean, in particular, that the recess extends along an axial extension of the base body.

In addition, an “outer diameter” of the base body as used herein is intended to mean, in particular, the greatest extension of the base body perpendicular to the central axis of the base body in an area or region of the base body located between the connecting regions at the proximal and the distal ends, and thus the area has no connecting means. As a result, the radial width of a connecting means does not contribute to the outer diameter of the base body.

Advantageously, a coupling is provided with a base body which has at least a weak spot which extends at least in an axial direction of the base body and is intended for splitting or slitting of the base body. In this context a “weak spot” as used herein is intended to mean, in particular, a thinned wall segment, a score line, a groove and/or other means to facilitate splitting or slitting. Other possibilities that are feasible are all embodiments that appear suitable to a person skilled in the art, such as a section of the base body manufactured of a material with less resilience and/or resistibility as the residual part of the base body. The weak spot generally extends along the whole axial extension of the base body. Moreover, the weak spot generally extends preferably in circumferential direction of the base body at least matched to a dimension and/or a width, respectively, of a tool for splitting or slitting, like, for example, a cutter. By means of the weak spot the opening of the base body and therefore, the removal of the delivery device could be performed easily and without disturbance of the location of the delivered medical device.

Moreover, it is provided that the weak spot is embodied as a thin wall segment having a uniform width in least an axial direction of the base body. Possible is also a uniform width in circumferential direction as described below. However, for the scope of the present disclosure, for the slittability of the hub, only the uniform width in axial direction is essential. Preferably, the thin wall segment extends uniformly in circumferential direction of the base body with a width that is at least matched to the dimension and/or the width, respectively, of the tool for splitting or slitting. Moreover, the width of the connected downstream delivery shaft of the delivery device is matched and/or preferably equal to the width of the thin wall segment.

A “thin wall segment” as used herein refers, in particular, to a segment or first segment of the base body which extends along a part of the circumference of the base body and partly abuts the recess and which is at least 1.2 times to 10 times thinner, preferably 1.5 times to 5 times thinner, and particularly advantageously 2 times to 3 times thinner than another, second segment of the base body, which extends along a part of the circumference of the base body, partly abuts the recess and is no part of a connection means.

The term “uniform” as used herein should be understood as homogeneous, even and/or similar. Minimal deviations in the uniformity, such as an irregularity about ±1% to 5% from the width of the thin wall segment, do not alter the scope of the definition. Due to the thin wall segment, the splitting and/or slitting can be realized without complications and especially gentle for structures and/or tissue located in proximity to the delivery device.

Helpfully, with respect to the thin wall segment a thicker wall segment is positioned diametrical opposite to the thin wall segment and wherein the thicker wall segment provides a structural support for the base body. The width of the thicker wall segment preferably increases in a radial direction of the recess from the proximal to the distal end of the base body. The thin and the thicker wall segments and/or the first and the second segments, respectively, could have the same circumferential length or different circumferential lengths. A slightly offset positioning of the thin and the thicker wall segments towards each other still falls within the spirit and scope of the present invention, as defined by the appended claims. The embodiment according to the present disclosure provides preferably a solid coupling which has only minimal risk of collapsing during the medical procedure.

Furthermore, it is advantageous when the connecting region at the proximal end of the base body has at least one Luer fitting. In this context, a “Luer fitting” as used herein is intended to mean, in particular, a male and preferably a female Luer fitting. It is therefore usefully possible to easily connect the coupling with devices embodied with state of the art Luer locks. As a result, the coupling can be advantageously used with a great range of devices.

In a further embodiment of the present disclosure, the connecting region at the proximal end of the base body has at least one tab extending in a circumferential direction of the base body. The tab could extend along an inner circumference and/or an outer circumference of the base body. Moreover, the tab could extend over the whole inner and/or outer circumference of the base body, via which a robust snap fitting connection with an upstream component, like, for example, the applicator, could be achieved.

It is furthermore provided that the connecting region at the proximal end of the base body has at least one tab extending over a part of the outer circumference of the base body. The tab is intended for engaging a threaded Luer lock fitting, specifically a male Luer fitting. Due to this mechanism, the connection between the coupling and the upstream component could be realised both reversibly and securely.

Furthermore, the connecting region at the proximal end of the base body has at least two tabs, which are positioned diametrical towards each other and are extending over a part of the outer circumference of the base body. Preferably, the tabs are intended to engage a threaded Luer lock fitting, specifically a male Luer fitting. Moreover, the tabs could have the same circumferential length or different lengths. A slight offset in positioning of the two tabs towards each other still falls within the spirit and scope of the present invention, as defined by the appended claims. Preferably, the weak spot is positioned centrically between the two tabs. By means of the embodiment according to the present disclosure, a well-balanced connection could be maintained which assures a smooth action of the interaction partners.

In addition, it is advantageous when the connecting region at the proximal end of the base body has at least two tabs which are arranged one after another in an axial direction of the base body. Moreover, the two tabs could have the same circumferential length or different lengths. Further, an axial distance of the tabs is matched to the width of the corresponding fitting partner or the threaded part of the male Luer fitting, respectively. Thus, the threaded connection between the coupling and the upstream component could be performed tightly and safely.

Further, providing at least one valve, which is positioned at the distal end of the base body, allows advantageously controlling a passage of media, like, for example, fluids, agents and/or medical devices through the coupling. Preferably, the valve is embodied as hemostatic and/or splittable or slittable valve. In another embodiment of the present disclosure, it is provided that the valve is embodied as a one-way valve, whereby an infusion of agents into the body could be allowed, but leakage of blood could be favourably precluded. Moreover, it is also provided that the valve could be embodied as a bidirectional valve, wherein the flow of media is beneficially precluded in either direction through the valve. Infusion and/or aspiration could preferably take place trough a cannula adapted to pass through the valve. Generally, it is also possible that the valve is embodied as an adjustable, compression, or syringe activated valve and/or as any other valve being feasible for a person skilled in the art.

Advantageously, the at least one valve is positioned distally with respect to the recess. Thus, the connecting region for the applicator is unaffected by the valve. Consequently, the connection function and the valve function could be arranged separately but at the same time positioned adjacent to each other. This, in turn, results in a space saving arrangement.

Furthermore, it can be advantageous when the base body is integrally formed with the delivery device. In this context “integrally formed” as used herein is intended to mean, in particular, that the base body and the delivery device are molded out of one piece and/or that the base body and the delivery device could only be separate with loss of function for one of the parts. By means of the embodiment according to the present disclosure, resources, costs and assembly efforts can be reduced profitably.

A good manageability can be achieved when the coupling has a handle which is attached to the base body. The handle is advantageously attached at the area between the connecting regions at the proximal and distal ends of the base body and/or integrally formed with the coupling. Moreover, it is embodied as a loop, whereby the handling could be increased and optimized.

Thus, the present disclosure provides desirably a single device that enables easy manipulation of the position and the infusion of diagnostic and/or therapeutic agents and which is subsequently capable of delivering, for example, a pacing lead and being removed by slitting or splitting.

Various other objects, aspects and advantages of the present invention can be obtained from a study of the specification, the drawings, and the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

Elements that are functionally identical or similar-acting are labelled using the same reference numerals in the figures. The figures are schematic depictions of the present invention. They do not depict specific parameters of the present invention. Furthermore, the figures merely show typical embodiments of the present invention and should not limit the present invention to the embodiments shown. To distinguish between the various embodiments, the letters “a” to “i” have been added to the reference characters of the figures as used in the specification. Specifically,FIGS. 1-3include the letter “a”.FIGS. 4-8include the letter “b”.FIG. 9includes the letter “c”.FIG. 10includes the letter “d”.FIG. 11includes the letter “e”.FIG. 12includes the letter “f”.FIG. 13includes the letter “g”.FIG. 14includes the letter “h”.FIG. 15includes the letter “i”.

Regarding elements in a figure that are not described further, reference is made to the respective description of the elements in preceding figures to avoid unnecessary repetition.

FIG. 1shows an apparatus38awhich is intended for delivering a medical device31a, like a lead7a, and an agent39a, like a radiocontrast, (seeFIG. 2) during a vascular procedure, to a target location and into a human's body lumen or a vasculature, respectively (not shown). The apparatus38aincludes an applicator26a, embodied as a syringe1a, a coupling22a, embodied as a hub2a, and a delivery device29awith a tubular member30a, embodied as a delivery shaft3a.

The coupling22ahas a base body23awith a proximal end24aand a distal end27a, wherein the proximal end24ais oriented towards an operator40a(seeFIG. 2). Moreover, the base body23ahas a recess9a, which extends between the proximal end24aand the distal end27aand presents a through hole. The distal end27ais embodied as a connecting region28afor the delivery device29a, wherein the connecting region28aand thus the base body23a, respectively, is integrally formed with the delivery device29a. Therefore, a delivery sheath5ais made up of the shaft3aand the hub2a. The proximal end24ais embodied as a connecting region25afor the applicator26a. The hub2ais adapted to accept a male Luer fitting6aof the Luer lock syringe1aor other device (not shown) including a male Luer fitting. Therefore, the connecting region25aat the proximal end24aof the base body23ahas a Luer fitting6a, which is realized by a friction fit of the male Luer fitting6aof the syringe1ain the recess9aof the base body23a.

The coupling22aor the hub2a, respectively, further includes a handle4awhich is attached to or integrally formed with the base body23ain a region41alocated axially between the connecting regions25a,28a. The handle4ais embodied as a loop42aand may be used to manipulate the delivery sheath5a, for example, during removal from the body by means of slitting or splitting.

FIG. 2illustrates use of such a delivery sheath5awherein a Luer lock syringe1ais connected to the hub2aof the delivery sheath5a. The Luer lock syringe1acan be held in one hand of the operator40aallowing simultaneous advancement or retraction, rotation, and/or infusion agent39aor aspiration of blood.

FIG. 3exemplifies a cross-section through the hub2aalong the image plane inFIG. 1. The hub2aincludes the recess9acapable of accepting a male Luer fitting6aof the syringe1a. The recess9amay comply with standards describing Luer fittings or may be modified. In this embodiment, the recess9ais positioned in the hub2asuch that the base body23ahas a weak spot33awhich extends in axial direction34aof the whole axial extension of the base body23aand is intended for splitting or slitting of the base body23awith a tool for splitting or slitting, like, for example, a cutter (not shown). The weak spot33ais embodied as a first or a thin wall segment10ahaving a uniform width35ain axial direction34aover the whole axial extension of the base body23a. Thus, the wall segment10aof the hub2ais substantially straight and/or has a substantially uniform thickness for ease of slitting. The slitting wall segment10amay be relatively thin, for example, compared to a second wall segment or the remaining wall segments of the hub2a, likewise to facilitate easy slitting. The thin wall segment10aabuts the recess9aat least over a segment43aof a circumference37aof the recess9a(not shown in detail; refer toFIG. 6). Also for easy slitting a downstream wall44aof the delivery shaft3ahas the same width as the thin wall segment10a.

With respect to the thin wall segment10a, a thicker wall segment11ais positioned diametrical opposite to the thin wall segment10a. The thicker wall segment11aabuts the recess9aat least over a segment45aof the circumference37aof the recess9a(not shown in detail; refer toFIG. 6) and extends continuously in a radial direction46aalong the axial direction34afrom the proximal end24ato the distal end27aof the base body23a. Thus, the thicker wall segment11aprovides a structural support for the base body23a. Therefore, the thin wall segment10ais, at the proximal end24a, about two times thinner than the thicker wall segment11aand, at a region towards the distal end27a, about three times thinner. Due to this and in order to facilitate slitting, a central axis18aof the recess9ais nonparallel with respect to a central axis32aof the outer diameter20aof the base body23aor the hub2a, respectively, and/or to the central axis19aof the hub's2adistal segment and/or the catheter shaft (not shown). In addition to the structural support of the nonparallel axes, they also accommodate Luer taper while maintaining the consistently thin slitting wall segment10a.

Additionally, the recess9ais not concentric with the outer diameter20aof the hub2aand/or with the distal lumen21aof the hub2aor catheter shaft (not shown). In other words, the recess9ais positioned eccentrically from the outer diameter20aof the base body23a, wherein the outer diameter20arefers to the region41alocated axially between the connecting regions25a,28a.

During a vascular procedure, the delivery sheath5aor the delivery shaft3a, respectively, with the introduced pacing lead is introduced into the right atrium to deliver the lead to the heart. A position of the delivery sheath5awithin the heart may be manipulated with the handle4aor the syringe1aby the operator40a. Additionally, radiocontrast may be infused in order to identify and/or cannulate the coronary sinus and/or its tributaries. After the exact positioning of the electrodes and the lead7aand the delivery sheath5awith the coupling22a, the delivery shaft3awill be slit and the delivery sheath5awill be removed leaving the pacing lead in place. Alternatively, the delivery sheath5a, including hub2amay be splittable (e.g., may be pealed away without the aid of a slitter or cutter) to facilitate its removal while leaving the lead in place.

InFIGS. 4 to 15C, eight alternative embodiments of the coupling22aare shown. Components, features and functions that remain identical are in principle substantially denoted by the same reference characters. To distinguish between the embodiments, however, the letters “a” to “i” have been added to the reference characters of the embodiments, as previously noted. The following description is confined substantially to the differences from the embodiment inFIGS. 1-3, wherein with regard to components, features and functions that remain identical, reference may be made to the description of the embodiment inFIGS. 1-3.

FIG. 4illustrates an alternative embodiment of a delivery sheath5bafter removal of a Luer lock syringe (not shown). The delivery sheath5bhas a coupling22bor hub2b, respectively, with a base body23band a tubular member30bor delivery shaft3barranged at a connecting region28bof a distal end25bof the base body23b. Thus, the delivery device29band the base body23bare integrally formed with each other. A medical device31bor a pacing lead7bis now inserted through the hub2bof the delivery sheath5b. A connecting region25bat a proximal end24bof the base body23ahas connecting means embodied as tabs8b, which extend in a circumferential direction36bof the base body23b. Only one tab8bfor engaging a threaded Luer lock fitting, specifically a male Luer fitting6b, of the syringe1bis shown inFIG. 4(seeFIG. 8for both). After delivery of the lead7b, the delivery sheath5bincluding hub2bmay be slit using a slitter (not shown) in order to remove the delivery sheath5bfrom the body while leaving the lead7bin place. Alternatively, the delivery sheath5b, including hub2bmay be splittable (e.g., may be pealed away without the aid of a slitter or cutter) to facilitate its removal while leaving the lead7bin place. The hub2bor the base body23bhas a least a weak spot33bembodied as a thin wall segment10bto facilitate splitting (seeFIG. 6). Alternatively, a score line or other means to facilitate splitting are feasible and are within the spirit and scope of the present invention. The weak spot33bor the thin wall segment10bextends in axial direction34bof the base body23band has a uniform width35bin axial direction34bof the base body23b(not shown).

FIG. 5is a perspective side view of the hub2bincluding one tab8barranged at the proximal end24b. A reach47bof the tab8bwhich extends from the side where the thin wall segment10bis located is longer than a reach48bwhich extends from a wall segment11bwhich is arranged opposite to the thin wall segment10b. Basically, one tab8bwould be sufficient for the Luer fitting. In a region41blocated between the ends24b,27ba handle4bis molded to the base body23b.

FIG. 6is a view from the back of the hub2blooking into a recess9bor a top view of the proximal end24b. The recess9bextending between the proximal end24band the distal end27bis positioned eccentrically from an outer diameter20bof the base body23b(seeFIG. 7a) and a central axis18bof the recess9bis nonparallel in respect to a central axis32bof the outer diameter20bof the base body23b(see alsoFIG. 5). The thin slitting wall segment10bis seen below. A thicker wall segment11bprovides structural support to the hub2band is positioned diametrical opposite to the thin wall segment10b. The thin wall segment10band the thicker wall segment11bare segments43b,45bwhich have roughly the same circumferential length49bwhich is about a fourth of the circumference37b, or about 90°.

The hub2bfurther includes two tabs8badapted to engage the Luer lock syringe or other threaded Luer adapter (not shown). As depicted, the threads or tabs8b,8b′ extend over a part of an outer circumference37bof the base body23bor only partially around the circumference37bof the proximal end24bof the hub2bso that the thin slitting wall segment10bremains accessible for slitting. Moreover, the two tabs8b,8b′ are positioned diametrical towards each other and have roughly the same circumferential length49bwhich is about a fourth of the circumference37b, or about 90°. Furthermore, surfaces50bof the tabs8b,8b′ which face in circumferential direction36bare embodied as rounded down to lighten the engagement of the tabs8b,8b′, which function as female Luer fitting6b′, with the male Luer fitting6b. The general features of the tabs8b,8b′ could also be applicable to the following embodiments inFIGS. 9, 10, 11, 13 and 15A-15C. In principle, the tab/luer thread could extend about 270°, omitting only the thin slitting wall segment. In this particular design, there is an additional break in the tab opposite the thin slitting wall segment to provide clearance for installation of a screw which is used in this specific design.

FIGS. 7 and 8further describe the positional relationship of the recess (which is a female Luer fitting6b′) with respect to the threads/tabs8b,8b′ and the outer diameter20bof the hub2bin order to facilitate slitting.FIG. 7Ashows the eccentric arrangement of the recess9bin respect to the outer diameter20bof the base body23b. Due to this, the thin wall segment10bcould be realized. InFIG. 7Ban arrangement according to a standard or state of the art device is shown. A recess R is arranged centrically in respect to an outer diameter OD, thus an inner diameter ID and the outer diameter OD are concentrically, both for simplicity of design as well as for flexibility in a location of threads or tabs T, T′. However, this results in a thick wall section S that is difficult to slit.

FIG. 8shows the female Luer fitting6b′ with the tabs8b,8b′ of the base body23bengaged in a male Luer fitting6bof a syringe1b. As the sealing surface of a Luer is only between an inner diameter51bof the female Luer fitting6b′ or the recess9b, respectively, and an outer diameter52bof the male Luer (and not between an outer diameters53b,20bof the threads/tab8b,8b′ and the base body23b, respectively, of the female Luer fitting6b′ and an inner diameter54bof a thread55bof the male Luer fitting6b), the Luer may still be constructed eccentrically such that the threads/tabs8b,8b′ are concentric with the inner diameter51bof the recess9b, but not with the outer diameter20bof the base body23b. Thus, the threads/tabs8b,8b′ will fit clearly within the thread55bof the male Luer lock fitting6bor syringe1band seal on the inner diameter51bof the female Luer fitting6b′ even while leaving a gap56bon the outside or between the circumference37bof the base body23band the thread55bof the male Luer filling6b.

Thus, outer contour57bof the male Luer fitting6bis concentric with the inner diameter52bof the male Luer fitting6band with the outer diameter52bof the male Luer fitting6band the inner diameter51bof the female Luer fitting6b, respectively, through center A. The outer diameter20bof the base body23bis not concentric with outer contour57bof the male Luer fitting6bor the inner diameter51bof the female Luer fitting6b′ and with the outer diameter52bof the male Luer fitting6b, but has its own center at B which is opposite the thin wall segment10bor the slitting side.

FIG. 9illustrates a variation of the tab8bthat may be used for securing a threaded Luer adapter (not shown) to a coupling22cor a hub2c. The tab8cis with respect to the Luer according toFIG. 5reduced in its size in circumferential direction36cof a base body23c. Generally, more than one tab8ccould be practicable.

FIG. 10illustrates a further variation on tabs8b,8cthat may be used for securing a threaded Luer adapter (not shown) to a coupling22dor a hub2d. A connecting region25dat a proximal end24dof a base body23dhas at least two tabs8d,8d′ which are arranged one after another in axial direction34dof the base body23d. Further, an axial distance58dof the tabs8d,8d′ is matched to the width of the corresponding male Luer fitting (not shown). In this embodiment, the distance58dis equal to the axial extension59dof one tab8d,8d′. Moreover, the tabs8d,8d′ have the same axial and circumferential lengths. The proximal tab8dmay have a tapered tip60din the region of a thicker wall11dto facilitate the engagement of the Luer connection. In general, more than two axially arranged tab8d,8d′ could be feasible. Also an arrangement of another duplex of tabs8d,8d′ with is positioned diametrical towards the first duplex is possible.

In further embodiments (not shown), the hub may be adapted with alternative means for attaching to a syringe or other device (not shown). For example, a syringe (not shown) and the hub may each be adapted with a snap fitting or other means (other than a threaded Luer fitting) for attaching to each other and enabling the hub to be manipulated by means of the syringe (not shown). Further, alternatively, the tab(s) may be omitted altogether, and the friction fit of male Luer fitting (not shown) in the recess (as shown inFIG. 3) may be sufficient to enable the hub to be manipulated by means of its attachment to a syringe (not shown).

FIG. 11illustrates a further alternative embodiment of a coupling22eor hub2e, respectively, which is a part of a delivery sheath5ewith a delivery device29eor a tubular member30embodied as a delivery shaft3efor delivering a medical device (not shown). The coupling22ehas a base body23ewith a recess9eextending between a proximal end24eand a distal end27eof the base body23e. Moreover, the recess9eis positioned eccentrically from an outer diameter20eof the base body23eand a central axis18eof the recess9eis nonparallel in respect to a central axis32eof the outer diameter20eof the base body23e. The hub2efurther comprises a slittable hemostatic valve12e, which is positioned at the distal end27eof the base body23e. The valve12eis positioned distally to the recess9eand is embodied as a one way valve, e.g., allowing infusion of agents into the body, but precluding leakage of blood (not shown). Tabs positioned at the proximal end24efor connecting the hub2eto a syringe are possible, but not shown.

FIG. 12illustrates a further alternative embodiment in which a coupling22for a hub2fcomprises a bidirectional valve12fsuch that flow is precluded in either direction through the valve12f. A syringe1ffurther comprises a cannula13fadapted to pass through the valve12fwhen a distal end61fof the syringe1fis engaged in the recess9f. Infusion and/or aspiration can take place through the valve12fby way of the cannula13fwhen it is crossing the valve12f. However, when the cannula13fis removed from the valve12f, no flow is permitted. A compression, or syringe activated valve (not shown) may also be used.

FIG. 13Aillustrates a further alternative embodiment of a coupling22gor a hub2gwhich could be connected to a connecting region62gof a delivery sheath5gwith a delivery device29gor a delivery shaft3g(for clearness connecting region62gis not shown true to original inFIG. 13A). Because syringes generally do not have a cannula such as could be used to bypass a bidirectional valve12g, or alternatively a one-way valve with a small through hole, a separate bypass tool14gmay be provided to adapt a syringe with a cannula to bypass the valve12g. The bypass tool14gwould be removed along with the syringe prior to slitting. In this embodiment, the coupling22gis embodied as a bypass tool14gand comprises a recess9gfor receiving the syringe or other male Luer fitting (not shown) and a cannula13gor a bypass sheath63gadapted to pass through the valve12g. The bypass tool14gmay be secured against longitudinal movement by friction between the bypass sheath63gand the hemostatic valve12g. Also, a side port of the delivery sheath5gand a handle4gis shown.

FIG. 13Bdepicts in more detail an embodiment of the connection region62gof a proximal end64gof the delivery sheath5gwith attachment means15g(valve12gnot shown). The connection region62g, which could also function as a handle, is embodied as a cap65gwith outer pins15gfor the connection with the coupling22gor a proximal end66gof the bypass tool14g, respectively. An alternative embodiment of a proximal end64g′ of an deliver sheath5g′ with only one pin15g′ is shown inFIG. 13C.

InFIG. 13D, an end-on view looking into the recess9gof the bypass tool14gis shown. As an example, a snap fitting may facilitate the connection of the bypass tool14gto the connecting region62gof the delivery sheath5g. The bypass tool14ghas at its proximal end66gan attachment means16gfor attaching the bypass tool14gto the connecting region62gand which is adapted to engage a corresponding feature or pins15g, respectively, on the delivery sheath5g. For example, the bypass tool14gmay have a twist-lock mechanism16gadapted to engage one or more features15gon the proximal end63gof the delivery sheath5g. The attachment means16gmay have an inner knurl or structure (not shown) to lock on one or more pins15g, located at the proximal end64gof the delivery sheath5g. Alternatively, or in addition to, it is possible that the proximal end66gof the bypass tool14gfurther has an outer structure for locking on a syringe (not shown). The bypass tool14gand the syringe may be secured against longitudinal movement by locking on the handle's pin15gand by friction between bypass sheath63gand the hemostatic valve12g. The bypass tool14gand the syringe may be secured against axial movement by locking on the handle's pin15g.

FIG. 14illustrates a further alternative embodiment, in which a coupling22hor hub2hembodied as a bypass tool14hcomprises a recess9hfor receiving a syringe1hor other male Luer fitting (not shown) and a cannula13hor a bypass sheath63hadapted to pass through a valve12h(seeFIG. 14A). The bypass tool14hfurther comprises an attachment means16hadapted to engage a corresponding feature on a delivery sheath5hshown inFIG. 14B. For example the bypass tool14hcomprising an attachment means16hadapted to clip to a handle4hof the delivery sheath5h(seeFIG. 14C).

FIGS. 15A to 15Cillustrate in a first and a second side view, as well as in a top view from a proximal end24i, an alternative embodiment where a delivery sheath5iwith a coupling22ior hub2iincluding an in-line side port17iadapted to receive a syringe (not shown) is depicted. Starting at the proximal end24iof a base body23iof the hub2i, the in-line side port17iextends in parallel to the base body23iand discharges with a curved segment67iinto a delivery shaft3iof the delivery device29idownstream of a valve12iwhich is positioned distally of a recess9iof the coupling22i(seeFIG. 15A). As could especially be seen inFIG. 15C, the in-line side port17iis arranged at a side68iof the base body23iwhich is not slit during the procedure and/or which is circumferentially located between a thin wall segment10iand a thicker wall segment11iwhich abut the recess9i. Tabs located at the proximal end24ifor connecting the hub2ito the syringe are possible but not shown. The in-line side port17imay be further adapted with conventional Luer locking mechanisms and does not need to be slit as part of the procedure.

It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. The present invention is not confined to the specific details set forth, but includes various changes and modifications that may suggest themselves to those skilled in the art, all falling within the spirit and scope of the present invention as defined by the following claims, which are to be given their full scope and breadth. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.

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