NZ787982A - Connector for transfer of an implant to a cathether - Google Patents

Abstract

connector for transfer of an implantable device from a loading tube to a delivery catheter, comprising: a first connecting portion (110) having a first distal end (120) configured to receive a delivery catheter (190); a second connecting portion (130) having a second proximal end (150) configured to receive a loading tube (180) extending towards the first distal end, the second connecting portion movably connected to the first connecting portion; and a biasing element (160) connecting the first and second connecting portions, having a relaxed configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second proximal end are moved apart; such that when the loading tube is received, upon receiving the delivery catheter by the first connecting portion, the loading tube is biased to the delivery catheter to form a connection for the transfer of the implantable device. to receive a loading tube (180) extending towards the first distal end, the second connecting portion movably connected to the first connecting portion; and a biasing element (160) connecting the first and second connecting portions, having a relaxed configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second proximal end are moved apart; such that when the loading tube is received, upon receiving the delivery catheter by the first connecting portion, the loading tube is biased to the delivery catheter to form a connection for the transfer of the implantable device.

Description

CONNECTOR FOR TRANSFER OF AN IMPLANT TO A CATHETHER Technical Field The present sure relates to a connector for transfer of an implantable device from a loading tube to a delivery catheter. The disclosure also relates to a method of manufacturing a connector.

Background Medical implants may be designed to be deployed at a particular location in the vasculature. In order to deploy the medical implant, a delivery catheter is directed through the vasculature to a target location, and the medical implant is pushed through the delivery catheter and deployed from the ry er at the target location.

A medical implant may need to be transferred from a loading tube to a ry er. In order to transfer the medical implant from the g tube to a delivery catheter, the g tube may be manually inserted into and held inside the delivery catheter during the er. Alternatively, a connector connecting the loading tube to the delivery catheter is used. Both methods e the use of both hands, and it is further difficult to ensure whether a proper connection n the loading tube and the ry catheter is achieved. As the medical implant is often delicate, it is important for the connection between the loading tube and the delivery catheter to be proper. For example, if the loading tube is secured too far away from the delivery er entrance, the connection may not provide a smooth transition and this may damage the implant. On the other hand, the loading tube may be d if pushed too far into the delivery catheter (for example it may collapse from the inward force ofthe walls of the catheter).

There is therefore a need for a connector which ensures the tion between the loading tube and the delivery catheter to safely transfer the medical implant.

Summary According to a first aspect, there is provided a connector for transfer of an implantable device from a loading tube to a delivery catheter, comprising: a first connecting portion having a first distal end configured to receive a delivery catheter, a second connecting portion having a second proximal end configured to receive a loading tube extending towards the first distal end, the second connecting portion movably connected to the first connecting portion; and a biasing element connecting the first and second connecting portions, having a relaxed configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second proximal end are moved apart, such that when the g tube is received, upon receiving the delivery catheter by the first ting portion, the loading tube is biased to the delivery catheter to form a connection for the transfer of the implantable device. As a force exerted on the first connecting portion is itted to the second connecting portion via the g element, the force exerted on the loading tube is dependent on the ties of the biasing element rather than the force d by a user, which may prevent the loading tube being forced too far into the delivery er.

The connector may further comprise a separating element, wherein when the delivery catheter is received, the separating element is d radially n a proximal end of the delivery catheter and the biasing element. The separating element prevents contact between the implantable device and the biasing element which may t damage to the implantable .

The g element may be housed by at least one of the first connecting portion and the second connecting portion, preventing damage to the biasing element.

The biasing element may comprise a resiliently extensible element having a proximal portion connected to the second connecting portion and a distal portion connected to the first connecting portion. The resiliently extensible element is a tensile spring. The biasing element may comprise a resiliently compressible element having a proximal portion connected to the second connecting portion and a distal portion connected to the first ting portion and the ently compressible element may be a compression spring.

The biasing element may be a spring having any suitable spring constant. The spring constant may be selected to that the loading tube is not forced too far into the deliver er by the spring. A suitable spring constant will depend on various factors such as the material used for the loading tube and its dimensions and can be determined from routine experimentation.

The first distal end may comprise a male or female screw thread to receive a female or male screw thread, respectively, of a delivery catheter.

The connector may further comprise a stopping element configured to prevent the first distal end and the second proximal end from moving closer than a closest distance to one another.

The first connecting portion may se a first tubular body and the second connecting portion may comprise a second tubular body slidable within the first tubular body. The first r body may comprise an outer grip. The first connecting portion is more easily handled by a user when the second tubular body is slidable within the first tubular body as the first tubular body has a greater radial extent.

The second connecting portion may se a second tubular body and a cap on a distal end of the second r body, and the first ting portion comprises a first tubular body and an inner tubular body within the first tubular body, the inner tubular body extending into the second connecting portion through the cap, the inner tubular body comprising a stopping portion inside the second tubular body, such that separation of the first connecting portion and the second connecting portion is ted by abutment of the cap and the stopping portion. The first connecting portion may comprise a first tubular body and a cap on a proximal end of the first tubular body, the first connecting portion extending into the second ting portion through the cap, the second tubular body comprising a stopping portion inside the first tubular body, such that separation of the first ting portion and the second connecting portion is prevented by abutment of the cap and the stopping portion.

The biasing element may comprise a resiliently compressible element extending between the stopping portion and the cap, and the resiliently compressible element may be a compression spring. The resiliently ssible element may be completely housed by the tubular bodies, the stopping portion and the cap, preventing damage to the element.

The loading tube may be received by the second connecting portion, and the loading tube may be fixedly attached to the second connecting n, for example by adhesive.

According to a second aspect, there is provided a method of providing a connector for transfer of an implantable device from a loading tube to a delivery catheter, sing: ing a first connecting portion having a first distal end red to receive a delivery catheter, providing a second ting portion having a second proximal end configured to receive a loading tube extending towards the first distal end, the second connecting portion movably connected to the first connecting portion; and providing a biasing element connecting the first and second connecting portions, having a d configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second proximal end are moved apart; such that when the loading tube is received, upon ing the delivery catheter by the first connecting portion, the loading tube is biased to the delivery catheter to form a connection for the transfer of the implantable device.

The method may further comprise receiving the loading tube by the second connecting portion. When the loading tube is readily provided during manufacture, the ly process is simpler for a user (who need only attach the connector to the delivery catheter).

The first connecting portion may comprise a first tubular body and an inner tubular body, the inner tubular body comprising a stopping n, and the ing connecting portion may comprise a second tubular body and a cap, the first tubular body sized to receive the second tubular body and the second tubular body sized to receive the inner r body, the method comprising: providing the biasing element, inserting the inner tubular body into a second distal end of the second tubular body, attaching the cap to a distal end of the second tubular body such that the inner tubular body extends through the cap and the stopping portion is housed by the second tubular body, and such that tion of the first connecting portion and the second connecting portion is prevented by abutment of the cap and the stopping portion, and ing the inner tubular body to the first tubular body, wherein the second tubular body is slidable within the first tubular body.

The biasing t may comprise a resiliently compressible element and be provided by connecting a proximal portion of the resiliently compressible element to the inner tubular body and a distal portion to the second tubular body, and the resiliently compressible element may be a compression spring.

The biasing element may comprise a ently extensible element and be provided by connecting a proximal portion of the resiliently extensible element to the second tubular body and a distal portion to the inner tubular body, and the resilient ible element may be a tensile . The g element may comprise a resiliently extensible element and be provided by connecting a proximal portion of the resiliently ible element to the second tubular body and a distal portion to the second tubular body, and the resiliently extensible element may be a tensile spring.

WO 89745 2020/080398 The first connecting portion may comprise a first tubular body and a cap, the second connecting n may comprise a second tubular body comprising a stopping portion, the first tubular body sized to receive the second tubular body, and the method may comprise: providing the biasing element, inserting the second tubular body into a proximal end of the first tubular body; and attaching the cap to a proximal end of the first tubular body, such that the second tubular body extends through the cap and the stopping portion is housed by the first tubular body, and such that tion of the first ting portion and the second connecting portion is prevented by nt of the cap and the stopping portion.

The biasing t may be a resiliently ssible element and be provided by connecting a proximal portion of the ently compressible element to the first tubular body and a distal portion to the second tubular body, and the resiliently compressible element may be a compression .

The biasing element may be a resiliently extensible element and be provided by connecting a proximal portion of the resiliently extensible element to the second tubular body and connecting a distal portion to the first tubular body, and the resiliently extensible element may be a tensile spring.

The resiliently compressible element may be provided to extend between the stopping portion and the cap.

According to a third aspect, there is provided a kit of parts sing a connector according to the first aspect including a loading tube, optionally wherein the loading tube comprises a marker and the loading tube is configured to be received by the second proximal end by inserting the g tube into the second proximal end until the marker is positioned at the second proximal end. The marker may assist the user in ng that the leading tube is correctly received.

Brief description of the drawings To enable a better understanding of the present disclosure, and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying schematic drawings, in which: Fig. 1A shows a connector according to one or more embodiments, Fig. 1B shows the connector of Fig. 1A with a loading tube ed; Fig. 1C shows the connector of Fig. 1A with a loading tube and a delivery catheter received; Fig. 2A shows a connector according to one or more embodiments in a first configuration; Fig. 2B shows the tor of Fig. 2A in a second configuration; Fig. 2C shows the tor of Fig. 2A in a third configuration; Fig. 3A shows a connector according to one or more embodiments in a first configuration; Fig. 3B shows the connector of Fig. 3A in a second configuration; Fig. 3C shows the connector of Fig. 3A in a third configuration; Fig. 4 shows a further connector according to one or more embodiments; Fig. 5 shows a further connector according to one or more embodiments; Fig. 6A shows a side view of a connector according to one or more embodiments; Fig. 6B shows an exploded view ofthe connector of Fig. 6A; Fig. 7 shows another connector according to one or more embodiments; Fig. 8 shows an implant which can be transferred from a loading tube to a ry catheter using a connector according to one or more embodiments; Fig. 9A shows an implant in a loading tube; Fig. 9B shows an t in a delivery catheter; and Fig. 9C shows a loading tube and a delivery catheter. ed description Throughout this disclosure, the term “implantable device” or “medical implant” may refer to a device which may be permanently or semi-permanently implanted in a human or animal body.

Fig. 1A shows a connector 100 for transferring an implantable device (i.e. a medical implant) from a loading tube to a ry catheter. The connector 100 comprises a first connecting portion 110 having a distal end 120 and a second connecting portion 130 having a proximal end 150. The first and second connecting portions are e relative to one another. More specifically, the connector 100 comprises a biasing element 160 ting the first and second ting portions 110, 130, such that when the first connecting portion 110 is moved in a distal direction (eg. when a distal force is exerted on the first connecting n, illustrated by arrow 170), the biasing element 160 biases the second connecting portion 130 in the distal direction. The biasing element 160 has a relaxed configuration in which the distal end 120 and the proximal end 150 are spaced apart by a predetermined distance, and the biasing element 160 is configured to bias the distal end 120 and the proximal end 150 to the relaxed configuration when the distal end 130 and the proximal end 150 are moved apart from the relaxed configuration. Namely, the biasing element 160 is resiliently deformable, and the movement of the first ting portion 110 in the distal direction deforms the biasing element 160, which results in a biasing force being exerted by the g element 160 on the second connecting n 130 due to deformation ofthe biasing t.

In the example illustrated by Fig. 1A, the g element 160 is a compression spring (i.e. a spring that is configured to transmit the distal biasing force when it is compressed from a relaxed configuration), with a proximal portion connected to first connecting portion 110 and a distal n connected to the second connecting portion 130. However, any resiliently deformable element capable of transmitting a distal force on the first connecting portion to the second connecting portion may be suitable. For example, in other examples a tensile spring (i.e. a spring that is configured to transmit the distal biasing force when it is extended from a relaxed configuration) is used having a proximal portion ted to the second connecting portion 130 and a distal portion connected to the first connecting n 110. Other types of spring or biasing element may also be used in in place of the illustrated compression spring.

Furthermore, the position of the biasing t 160 in the connector 100 may also be varied. For example, when a biasing element is used that transmits the distal force by extension from a relaxed configuration, a distal portion of the biasing element 160 may be connected to the first connecting portion 110 at any point along its longitudinal length and a proximal portion of the biasing element may be connected to the second ting portion 130 at any point along its longitudinal length. Conversely, when a biasing element is used that transmits the distal force by compression from a relaxed configuration, a distal portion of the biasing element 160 may be connected to the second ting portion 130 at any point along its udinal length and a proximal portion of the biasing element 160 may be connected to the first connecting portion 110 at any point along its longitudinal length. In the rated example the biasing t 160 is housed by the first connecting n 110. In some examples, the biasing element 160 may be housed by the second connection portion 130 or located partially or wholly al to the first connecting portion l 10.

The second connecting portion 130 is configured to receive a loading tube 180 at the proximal end 150 such that the loading tube extends toward (i.e. in the direction of) the distal end 120 of the first connecting portion 110, as illustrated in Fig. 1B. For example, the proximal end 150 may comprise an aperture through which the g tube is configured to extend. The loading tube 180, when received by the second connecting portion 130, may be connected to the second connecting portion 130 by a frictional fit or may be otherwise fixed to the second connecting portion 130, for e via adhesive.

The first ting portion 110 is configured to receive a delivery catheter 190 at its distal end 120, as rated in Fig. 1C. More cally, the first ting portion 110 is configured to hold the delivery catheter 190 in a predetermined position. For example, the distal end 120 may be configured to receive the delivery catheter in a onal fit, a click fit, a screw fit or any other suitable connecting mechanism to securely hold the delivery catheter 190 in position.

When the loading tube 180 is received as shown in Fig. 1B, a user of the connector 100 connects the delivery catheter 190 to the distal end 120 of the first connecting portion 110 (e.g. by manual manipulation of the first connecting portion 110 and the delivery catheter 190). As a result, a distal force is exerted on the first connecting portion 110 by the user, which is transmitted to the second connecting portion 130 via the biasing element 160, and in turn to the loading tube 180. As the loading tube 180 begins to extend into the delivery catheter 190, a frictional force in the proximal ion is exerted on the loading tube 180 by the delivery catheter 190. This frictional force causes the biasing element 160 to deform away from its relaxed ration. Advantageously, the deformation of the biasing element 160 acts as a dampener such that the loading tube 180 is not forced to extend too far inside the delivery catheter 190, which could cause damage to the loading tube 180 (for example the loading tube 180 may radially collapse, affecting ry of the medical implant to the ry er). In other words, the force exerted on the g tube when ting the delivery catheter is determined by the properties of the biasing element 160 (e.g. the spring constant) rather than the force exerted by the user of the connector. As such the connector 100 reduces the risk of a user forcing the loading tube 180 too far into the delivery catheter 190 and a proper connection (i.e. having a smooth or continuous transition) is formed by the connector 100.

The conf1gured positions ofthe loading tube 180 and the delivery catheter 190 may depend on the ions of the connecting portions and the requirements of the particular nature of transfer of the medical implant between the loading tube 180 and catheter 190. For example, the connector may be configured to receive the loading tube and delivery catheter such that when both are received in the correct configurations, the loading tube 180 terminates at or partially within the ry catheter 190. The force exerted by the biasing element 160 on the second ting n 130 (and thus the loading tube 180) will depend on the dimensions (e.g. longitudinal lengths) of the connecting portions, the configurations of the loading tube 180 and delivery catheter 190 when received by the connecting portions and the elastic properties of the biasing element 160 (e.g. the spring constant). Therefore, for a given connector 100, a biasing element 160 with a lower spring nt will exert a lower force on the loading tube 180. As such the biasing element 160 can be selected such that the force exerted on the loading tube 180 does not exceed a old value. This prevents the loading tube 180 from being damaged whilst also ensuring a proper connection between the loading tube 180 and delivery catheter 190. In some examples, the loading tube 180 may have any suitable outer diameter which is configured to fit inside the corresponding catheter 190 (i.e. an outer diameter which is r than the inner diameter of the corresponding catheter 190). For example, the loading tube may have an outer er of l lmm or less, for example between 0.66mm (2 French gauge) and 3.33mm (10 French gauge). In a specific example, the loading tube 180 has an inner diameter of 0.027in (0.6858mm) and an outer diameter of 0.03lin (0.7874mm) and the catheter 190 has an inner diameter of 0.03 8in 2).

In other examples, there may be provided a proximal portion at the proximal end of the delivery catheter 190 which is sized to fit the loading tube 180 (i.e. the proximal portion has an inner diameter which is greater than the outer diameter of the loading tube). The proximal portion may taper in a distal direction towards the main body of the delivery catheter 190 such that the inner diameter of the delivery catheter (distal to the tapered proximal portion) is less than the inner diameter of the loading tube 180. The proximal portion may be configured to connect to any of the connectors disclosed herein. Fig. 9C shows one such example of a ry catheter having a tapered proximal portion 950. The tapered portion allows the implant to be ly transferred from a loading tube having a larger inner diameter than the inner diameter of the delivery catheter (i.e. the inner diameter of the distal portion of the delivery catheter). ingly, the inner er of the g tube may be larger or smaller than the inner diameter of the delivery catheter.

In an example, the loading tube 180 has an inner diameter of 0.048in 2mm) and an outer diameter of 0.083in 2mm) and the catheter 190 has an inner diameter of 0.03 8in (0.9652mm). In yet another example, the g tube 180 has an inner diameter of n (l.651mm) and an outer diameter of O.ll40in (2.8956mm) and the catheter 190 has an inner diameter of 0.056in (1.4224mm).

In the illustrated example, the second connecting portion 130 comprises a tubular body slidably ed by a r body of the first connection portion 110. In some embodiments, the radial extent of the first connecting portion 110 may be less than the radial extent of the second connecting portion 130. For example, the first connecting portion 110 may comprise a tubular body slidably received inside a tubular body of the second connecting portion 130. The biasing element 160 (compressible or extensible) can be ly positioned to cause the required biasing force. The first ting portion 110 having a larger radial extent may be preferred, as the first connecting portion is to be manually used by the user to attach the delivery er, and the connector 100 is thus easier to use if the second connecting portion 130 is of a smaller er and received inside the first connecting portion 110 (i.e. lowers the likelihood of a user accidentally pushing the second connecting portion 130 in a distal direction, which would exert a direct force from the user to the loading tube 180).

Fig. 2A schematically illustrates a connector 100 which uses a compression spring as the biasing element 160. A proximal portion of the spring is connected to the first connecting portion 110 and a distal portion of the spring is connected to the second connecting portion 130. In the illustrated example, the biasing element 160 is completely housed within the first connecting portion 110, which advantageously protects the biasing element from damage during use. In the example, when the first connecting portion 110 is moved in the distal direction (Fig. 2B, illustrated by arrow 210), the ssion spring compresses and exerts a distal biasing force on the second connecting portion 130. The second connecting portion 130 then moves in a distal direction (Fig. 2C, illustrated by arrow 220) based on the biasing force exerted by the biasing t 160. It will be appreciated by the skilled person that other ently compressible biasing elements may be used in place of the compression spring.

Fig. 3A illustrates a connector 100 which uses a tensile spring as the g element 160.

A proximal portion of the spring is connected to the second connecting portion 13 and a distal n of the spring is ted to the second connecting portion 130. In the illustrated e, the biasing element 160 is tely housed by the first connecting portion 110, again protecting the biasing element 160 from damage. Alternatively, the biasing t 160 may be situated partially or wholly externally to the first connecting portion 110. In the example, when the first connecting portion 110 is moved in the distal direction (Fig. 3B, illustrated by arrow 310), the compression spring stretches and exerts a distal biasing force on the second connecting portion 130. The second connecting portion 130 then moves in a distal ion (Fig. 3C, illustrated by arrow 320) based on the biasing force exerted by the g element 160. It will be appreciated by the skilled person that other resiliently extensible biasing elements may be used in place of the tensile spring.

Fig. 4 illustrates another connector 100 according to the present sure. The connector 100 comprises a first connecting portion 110, a second connecting portion 130 and a biasing element 160 as in any of the previously disclosed examples. Additionally, the connector comprises an annular separating element 410 having a central lumen and configured to be positioned radially inward of, and extending longitudinally along the biasing t 160. Advantageously, the ting element 410 provides a central lumen for receiving the loading tube 180 and/or the delivery catheter 190, which is isolated from the g element 160. This prevents the medical implant from interacting with the biasing element 160 during transfer, thereby preventing damage to the medical implant during transfer from the loading tube to the delivery catheter, particularly when an intermediate longitudinal gap exists between the loading tube 180 and the delivery catheter Whilst the separating t 410 in the illustrated example is an dual element, another element of the connector 100 may act as the separating element 410. For example, in Figs. 1A to 1C, 2 and 6 the second connecting portion 130 also acts as the separating element 410 by preventing interaction between the medical implant and the biasing element 160 during transfer.

WO 89745 Fig. 5 illustrates a further connector 100 according to the present disclosure. The connector 100 comprises a first connecting portion 110, a second connecting portion 130 and a biasing element 160 as in any of the previously disclosed examples. The connector further comprises a stopping element (or stopper) 610. The stopping element 610 is red to prevent the second connecting portion 130 from moving beyond a t proximity to the al end 120 of the first connecting portion 110. Advantageously, this prevents the loading tube 180 from being pushed too far into the delivery catheter 190 (for example if the user accidentally pushes the second connecting portion 130 in the proximal direction during use). In the illustrated e, the stopping element 610 comprises a sion extending radially inward from the first connecting portion 110 which abuts a distal end of the second ting portion 130 if the second connecting portion 130 is moved towards the distal end of the first connecting portion 110. In other examples, the ng element 610 may comprise a protrusion extending radially outwardly from the second connecting portion 130 and configured to abut a portion of the first connecting portion 110. The first and second connecting portions may be selected to prevent nt of the second connecting portion 130 beyond a closest ity to the distal end. For example, any suitable fiange, protrusion, depression or combination could be used. Additionally, the relative shapes of the connecting portions could be designed to achieve this feature. For example, the stopper could be formed by a tapered shape of the first connecting portion 110.

It is noted that in some examples, an element of the connector could be configured to act as both a r 610 and a separating element 410 as described above. For example, the separating element 410 shown in Fig. 4 may have an outer diameter which is greater than the inner er of the second connecting portion 130, thereby preventing the second connecting portion 130 from moving beyond a closest proximity to the proximal end 120 of the first connecting portion 110.

Figs. 6A and 6B show yet another connector 100 according to the present sure. As in the case of the previously disclosed examples, the illustrated connector 100 comprises a first connecting portion 110 configured to receive a delivery catheter, a second connecting portion 130 red to receive a delivery catheter and a biasing element (not shown in Fig. 6A) connecting the connecting portions. The first connecting n 110 and the second connecting portion 130 comprise first and second r bodies 725, 715, with the second tubular body 715 being slidably received within the first tubular body 725. As in the previously disclosed examples, the biasing t 160 transmits a distal force exerted on the first connecting portion 110 to the second connecting portion 130. As discussed previously, for a given connector 100 with given dimensions and configurations when the delivery tube and delivery catheter are received, a biasing t 160 with a lower spring constant will exert a lower force on the g tube 180. As such the biasing t 160 can be selected such that the force exerted on the loading tube does not exceed a threshold value. This prevents the loading tube from being forced too far into the catheter and being damaged (or radially collapsing), whilst also ensuring a proper connection between the g tube 180 and delivery catheter 190 In the illustrated example, the second connecting portion 130 comprises a cap 730 disposed on a distal end of the second tubular body 715. The first connecting portion 110 additionally comprises an inner tubular body 740 ing into the second tubular body 715 (and slidably received) through the cap 730. The inner tubular body 740 additionally comprises a stopping portion (or stopping element) 750 inside the second tubular body 715. Separation of the first connecting portion 110 and the second connecting portion 130 is prevented by abutment of the cap 730 and the stopping portion 750.

The first connecting portion 110 may additionally comprise a grip 720 for assisting the user in connecting the delivery catheter 190. For example, the grip 720 may have a number of depressions in the surface of the first connecting portion 110.

Whilst any suitable mechanism may be used to connect the delivery catheter to the first connecting n 110, in the illustrated example a Luer lock 710 is used. Likewise, any suitable ism for connecting the loading tube may be used, such as a frictional f1t 760 having an inner diameter closely matched to the outer er of the loading tube it is configured to receive.

Fig. 6B shows an exploded view of the connector 100 shown in Fig. 6A. As can be seen from the exploded view, the individual components of the connector 100 can be easily assembled to form the tor 100. More particularly, in the illustrated example the g element 160 is a compression spring configured to be mounted on the inner tubular body 740 and configured to extend between the stopping portion 750 and the cap 730. The position of the compression spring between the cap and stopping portion provides a method of assembly as follows: the g t 160 and cap 730 are mounted on the inner tubular body 740. The inner tubular body 740 is then connected to the first r body 725, for example by an interference f1t onal f1t, click fit or adhesive, at a distal portion of the first r body 725. The second tubular body 715 is then inserted into the first tubular body 725 until the cap is connected to the second tubular body 715 (for example via an interference, frictional or click fit or adhesive). It will be understood that in that case, the inner tubular body 740 also acts as a separating element 410.

Whilst the biasing t 160 is shown as a compression spring extending between the ng n 750 and the cap 730, other compressible biasing elements may be used.

Additionally, other locations may be used for the biasing element 160 as discussed with respect to the previous examples. Alternatively, a tensile spring or other extensible biasing element may be used as discussed with t to the previous examples.

It will also be appreciated by the skilled person that the grip 720 may be omitted.

Fig. 7 shows another connector 100 according to the present disclosure. As in the case of the previously disclosed examples, the illustrated connector 100 comprises a first connecting n 110 configured to receive a delivery catheter, a second connecting portion 130 configured to e a delivery catheter and a biasing element 160 ting the connecting portions. The first and second ting portions 110, 130 again comprise first and second tubular bodies 825, 815. The first connecting portion 110 comprises a cap 820 on a proximal end of the first tubular body 825. The second tubular body 815 extends into the first tubular body 825 (and is slidably received) through the cap 820. The second tubular body 815 comprises a stopping portion or stopping element 810 inside the first tubular body 825, such that separation of the first and second connecting portions is prevented by nt ofthe cap 820 and the stopping n 810.

As in previous examples, a compressible or an extensible biasing element 160 may be used. For e, the g element may comprise a compressible biasing element 160 such as a compression spring extending between the cap 820 and the stopping portion 810.

In that configuration, the method of assembly may be as follows: the ng portion 810 is connected to a distal end of the second tubular body 815 (or it may be unitary with the second tubular body). The biasing element 160 is then mounted on the second tubular body 815. The second tubular body 815 and the biasing element 160 is then inserted into the first tubular body 825. The cap 820 is mounted on and connected to the first r body 825 such that the second tubular body 815 extends through the cap 820. The cap 820 may be connected to the first tubular body 825 by any suitable mechanism, such as interference fit, frictional fit, click fit or via adhesive.

It will again be understood that whilst the biasing element 160 is shown as a compression WO 89745 spring extending between the stopping n 810 and the cap 820, other ssible biasing ts may be used. Additionally, other locations may be used for the ssible biasing element 160 as discussed with respect to the previous examples.

Alternatively, a tensile spring or other extensible biasing t may be used as discussed with respect to the previous examples.

It is noted that in the ration where the biasing element 160 extends between the cap 820 and the stopping portion 810, the second tubular body acts as a separating element A connector according to the present disclosure may be formed by the following method: - providing a first connecting portion having a first distal end configured to e a delivery catheter; - providing a second connecting portion having a second proximal end configured to receive a loading tube extending towards the distal end, the second connecting portion movably connected to the first connecting portion, and - ing a biasing element connecting the first and second connecting portions, having a relaxed configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second proximal end are moved apart from the relaxed configuration, such that when the loading tube is received, upon receiving the ry catheter by the first connecting portion, the loading tube is biased to the delivery catheter to form a connection for the transfer of the implantable device.

It is noted that the order of steps noted above does not necessarily imply a chronological order. The loading tube 180 may also be connected to the second connecting portion 130 during manufacture to simplify the connecting process for a user.

As disclosed in some of the examples herein, the first connecting portion may se a first r body and an inner tubular body, the inner tubular body may comprises a stopping portion, and the seconding connecting portion may comprise a second tubular body and a cap, wherein the first tubular body is sized to receive the second tubular body and the second tubular body sized to receive the inner tubular body. In that case, the method may comprise (not necessarily chronologically): - providing the biasing element, - inserting the inner tubular body into a second distal end of the second tubular body, attaching the cap to a distal end of the second tubular body such that the inner tubular body extends through the cap and the stopping portion is housed by the second tubular body, and such that separation of the first connecting portion and the second connecting portion is prevented by abutment ofthe cap and the stopping portion; and - attaching the inner tubular body to the first r body, wherein the second tubular body is slidable within the first tubular body.

The biasing element may comprise a resiliently compressible element or a resiliently extensible element and may be provided at any suitable location on the connector as sed in the examples disclosed herein.

For example, the biasing t may se a resiliently compressible element (e.g. a compression spring) and be provided by connecting a al portion of the resiliently compressible element to the inner tubular body and a distal portion to the second tubular body. In some examples, the resiliently compressible element is ed to extend between the ng portion and the cap.

Alternatively, the biasing element may comprise a resiliently extensible element (e.g. a tensile spring) and be provided by connecting a proximal portion of the ently extensible element to the second tubular body and a distal portion to the inner tubular body, or be provided by by connecting a proximal portion of the resiliently extensible element to the second tubular body and a distal portion to the second tubular body.

As disclosed in some examples herein, the first connecting portion may instead comprise a first tubular body and a cap, the second connecting portion comprising a second tubular body comprising a stopping portion, the first tubular body sized to receive the second tubular body, in which case the method may comprise (not necessarily chronologically): - providing the biasing t, - inserting the second r body into a proximal end of the first r body, and - attaching the cap to a proximal end of the first tubular body, such that the second tubular body extends through the cap and the stopping portion is housed by the first tubular body, and such that separation of the first ting portion and the second connecting portion is ted by nt of the cap and the stopping portion.

Again, the biasing element may comprise a resiliently compressible or extensible element.

For example, the biasing element may be a resiliently compressible element (e.g. compression spring) and may be provided by connecting a proximal n of the resiliently compressible element to the first tubular body and a distal portion to the second tubular body. In some examples, the resiliently compressible element is provided to extend between the stopping portion and the cap.

Alternatively, the biasing element may be a resiliently extensible element (e.g. tensile spring) and be provided by connecting a proximal portion of the resiliently extensible element to the second tubular body and connecting a distal n to the first tubular body.

The device may be ed to the user as a kit of parts comprising a connector according to any of the examples disclosed herein and a loading tube for being received by the connector. The loading tube may comprise a marker and the loading tube may be configured to be received by the second proximal end by inserting the loading tube into the second proximal end until the marker is positioned at the second proximal end. The user is readily able to assemble, from the visual cue of the marker, the connector and loading tube such that the loading tube will extend to the intended position in the connector when the delivery catheter is connected such that a secure connection for transfer of the medical implant is achieved.

The connectors described herein may be suitable for any medical implant, for example an embolisation device 900 as shown in Fig. 8 having a stem 910 and a ity of flexible bristles 920 extending radially outwards from the stem. A first group of bristles may be grouped in a first e segment 920a configured to extend in a first longitudinal direction. A second group of bristles may be grouped in a second bristle segment 920b configured to extend in a second longitudinal direction opposite to the first longitudinal ion. The implant 900 may also comprise a flow restricting membrane 930, for example located longitudinally within one ofthe segments with bristles either side.

Fig. 9A shows an t 900 in a loading tube 180. The loading tube 180 is connected to a delivery er 190 using any of the connectors disclosed herein (the tor is omitted from Fig. 9A for simplicity). Once the loading tube 180 is connected to the delivery catheter 190 using a connector, the implant 900 may be pushed distally through the loading tube 180 (for example using a pushing element extending longitudinally through the loading tube 180) and into the delivery er 190. Fig. 9B shows the t 900 in the delivery catheter 190 after it has been transferred from the loading tube 180.

It will be appreciated that the es described with respect to one illustrated example are able to the other examples. For example, any suitable biasing t may be used in each e and may be positioned at any suitable point on the device as disclosed above.

Further, any of the disclosed connectors may additionally se one or more of a separating element, a stopping element, or any of the other elements described herein.

The various ents of the connector may be made from any suitable al. For example, the ents may be made of moulded plastic or metal.

All of the above are fully within the scope of the present disclosure, and are considered to form the basis for alternative embodiments in which one or more combinations of the above described features are applied, without limitation to the specific combination disclosed above.

In light of this, there will be many alternatives which implement the teaching of the t disclosure. It is expected that one skilled in the art will be able to modify and adapt the above disclosure to suit its own circumstances and requirements within the scope of the present disclosure, while retaining some or all technical effects of the same, either disclosed or derivable from the above, in light of the common general dge in this art. All such equivalents, modifications or adaptations fall within the scope of the present disclosure.

PCT/EP 2020/080 398 - 30.11.2021 2020/080398 19 219 261 CLEARSTREAM TECHNOLOGIES LIMITED November 29, 2021

Claims (3)

1. A connector for transfer of an implantable device from a g tube to a delivery er, comprising: a first connecting portion having a first distal end configured to hold a delivery catheter in a predetermined position; a second connecting portion having a second proximal end receiving a loading tube extending towards the first distal end, the second connecting portion y connected to the first connecting portion; and 10 a biasing element connecting the first and second connecting portions, having a relaxed configuration in which the first distal end and the second proximal end are spaced apart by a predetermined distance, and configured to bias the first distal end and second proximal end to the relaxed configuration when the first distal end and second al end are moved apart, 15 such that when the delivery catheter is in the predetermined position, the loading tube is biased to the delivery er to form a connection having a continuous transition between the loading tube and the delivery catheter for the transfer of the implantable device. 20

2. The tor of claim 1, further comprising a separating element, wherein when the delivery er is received, the separating element is located radially between a proximal end of the delivery catheter and the biasing element, and/or wherein the biasing element is housed by at least one of the first connecting portion and the second connecting portion.

3. The connector of any preceding claim, wherein the biasing element comprises a resiliently ible element having a al portion connected to the second connecting portion and a distal portion connected to the first connecting portion, preferably wherein the resiliently extensible element is a e spring, or 30 wherein the biasing element ses a resiliently compressible element having a proximal portion connected to the second connecting portion and a distal portion connected to the first connecting portion, preferably wherein the resiliently compressible element is a compression . AMENDED SHEET PCT/EP