WO2018149751A1

WO2018149751A1 - Access device

Info

Publication number: WO2018149751A1
Application number: PCT/EP2018/053325
Authority: WO
Inventors: Patrick Marie José ROSA; Massimo Giovanni LEMMA
Original assignee: Andocor Nv
Priority date: 2017-02-20
Filing date: 2018-02-09
Publication date: 2018-08-23
Also published as: BE1024992A1; BE1024992B1

Abstract

Access device for placement in a hole in a tissue wall, comprising: an elongated hollow body having an insertion end and a connection end; anchoring means to anchor the elongated hollow body to the tissue wall, comprising: an external abutment member to surround the hole in the tissue wall; a tensioning member coupling the external abutment member to the elongated hollow body at the side of the connection end; and an internal abutment member arranged at the side of the insertion end, wherein the tensioning member is configured to exert a force on the internal abutment member and the external abutment member such that the tissue wall is pressed between the internal abutment member and the external abutment member; a valve system to block fluid from flowing outside the elongated hollow body and to allow the introduction of medical equipment into the tissue wall hole via the connection end.

Description

Access device

Field of Invention

The field of the invention relates to an access device for placement in a hole in a tissue wall. Particular embodiments relate to the field of an access device for use in minimally invasive surgery procedures.

Background

During minimally invasive surgery (MIS) procedures, a small incision is made in a tissue wall to create a small hole or opening in the tissue wall through which small hole surgical instruments or medical solutions can be supplied to a further located region of interest, e.g. via a cannula. As compared to patients undergoing a conventional surgery procedure where relatively large openings are created to reach a region of interest, MIS patients tend to recover faster and experience less discomfort.

An example of a MIS procedure is a cardiac surgery wherein a central cannulation is performed in combination with a purse string technique. Typically, various types of cannulas such as arterial, cardioplegia, venous, and vent are inserted in the blood vessel or in the heart and mechanically blocked with a single or double purse string. The purse string prevents the entrance of air in the circulatory system and avoids bleeding. Moreover, the purse string is used to close the insertion hole when the cannula is taken out of the vessel.

Summary

During MIS procedures, the space to manoeuvre surgical instruments is very limited and preparing a purse string is a difficult, error-prone and time-consuming task. Moreover, when the cannula is removed from the incision hole, it is possible that leaking or bleeding occurs through the incision hole. In such a case, it is required to provide an additional stitch to assure a good closure.

The object of embodiments of the invention is to provide an access device which no longer requires the assistance of purse strings or stitches to mechanically block the device or to prevent leaking and/or bleeding, respectively.

According to a first aspect of the invention there is provided an access device for placement in a hole in a tissue wall. The access device comprises an elongated hollow body having an insertion end and a connection end, the elongated hollow body being configured to be inserted into the hole in the tissue wall such that the insertion end is situated at an inside of the tissue wall and the connection end is situated at an outside of the tissue wall. The access device further comprises anchoring means configured to anchor the elongated hollow body to the tissue wall, the anchoring means comprising an external abutment member moveably arranged around the elongated hollow body between the insertion end and the connection end, said external abutment member being configured to surround the hole in the tissue wall at the outside when the insertion end of the elongated hollow body is at the inside; a tensioning member coupling the external abutment member to the elongated hollow body at the side of the connection end; and an internal abutment member arranged at the side of the insertion end of the elongated hollow body, wherein the tensioning member is configured to exert a force on the internal abutment member and the external abutment member such that the tissue wall is pressed between the internal abutment member and the external abutment member. The access device further comprises a valve system positioned inside the elongated hollow body, between the external abutment member and the connection end, said valve system being configured on the one hand to block fluid from flowing outside the elongated hollow body and on the other hand to allow the introduction of medical solution or equipment into the inside of the tissue wall via the connection end of the elongated hollow body.

Embodiments of the invention are based inter alia on the insight that the anchoring means provide mechanical stability to the access device by connecting the elongated hollow body to the tissue wall and locking the elongated hollow body to the tissue wall while the elongated hollow body is inserted into the hole in the tissue wall. This way, there is no need for the use of a purse string or any other additional separate tool to immobilize the access device within the hole. The external abutment member is moveable along the elongated hollow body at the outside of the tissue wall and can be positioned against the edge of the hole of the tissue wall to surround the hole and to seal the space between the outside of the elongated hollow body and the edge of the hole. This way, no substances can be exchanged between the inside and the outside of the tissue wall, except for via the inside of the elongated hollow body, when the valve system allows it. When the external abutment member is in the sealing position, and the insertion end of the elongated hollow body, along with the internal abutment member, is at the inside of the tissue wall, the tensioning member exerts a force on both the internal and external abutment members such that both members are pressed against each other with the tissue wall therein between. Because the tensioning member applies this force on the external and internal abutment member, the access device is stably anchored onto the tissue wall and the elongated hollow body is positioned firmly in the hole in the tissue wall. This way medical equipment can be introduced into the hole via the elongated hollow body of the access device in a reliable manner.

Moreover, the valve system prevents fluids or other substances from travelling or leaking from one side of the tissue wall to the other side through the elongated hollow body. The access device need not be removed from the hole, but can remain there as a closing device, thereby demolishing the need for stitches or purse string to close the hole. The described access device has the functionality to allow medical equipment or medical solutions to be inserted through the hole via the elongated hollow body and the one-way valve system. However, when no medical equipment is inserted through the elongated hollow body, the valve system closes and the access device has the functionality of a closing device, which closes the hole in the tissue wall and prevents any form of traffic through the hole. Moreover, the route through the elongated hollow body can be reused when needed. For example, this may be advantageous to perform a check-up of an executed MIS procedure some time after actual execution of the MIS procedure.

In other words, the above described access device functions both as an access device, to allow easy access for medical equipment and/or medication, and as a closing device, to close and seal the hole in the tissue wall to prevent leaking and/or bleeding. The described access device can thus allow to access the vessels or the cavities of a human body and to deliver fluids but can also be used to deliver an implantable device.

According to an embodiment the internal abutment member comprises at least one deployable element which is switchable between an insertion position, wherein the at least one deployable element is oriented substantially parallel with a longitudinal axis of the elongated hollow body, and an anchoring position, wherein the deployable element is oriented substantially parallel with the tissue wall.

When in the insertion position, the at least one deployable element is positioned along and against the outside of the elongated hollow body. This way, the elongated hollow body can easily be inserted into the hole in the tissue wall together with the at least one deployable element, without the deployable element forming an obstruction. When in the anchoring position, the at least one deployable element extends outwardly from the outside of the elongated hollow body. This way, the at least one deployable element, when in the anchoring position, spans a surface such that the at least one deployable element of the internal abutment member can be pressed against the external abutment member on the other side of the tissue wall. In an embodiment, the at least one deployable element, when in the anchoring position, is positioned substantially perpendicular with regard to the outside of the elongated hollow body.

According to an embodiment the external abutment member comprises holding means which are configured for holding the at least one deployable element in the insertion position when the insertion end of the elongated hollow body is to be inserted into the hole, and for releasing the at least one deployable element to reach its anchoring position when the insertion end of the elongated hollow body is inserted into the hole.

The holding means prevent the at least one deployable element to deploy and reach its anchoring position before the insertion end has travelled through the hole and is inside of the tissue wall. This way, the at least one deployable element of the internal abutment member remains in its insertion position, at least until the insertion end has travelled through the hole, thereby enabling a clean passage through the hole. According to an embodiment the at least one deployable element is made of a flexible material such that the at least one deployable element, in its anchoring position, is pressed fittingly against the tissue wall by the tensioning member.

When the at least one deployable element is pressed against the external abutment member by means of the tensioning member, with the tissue wall positioned in between, the at least one deployable element provided an anchoring function together with the external abutment member. In addition, because of the flexible qualities of the at least one deployable element, the internal abutment member may also function as a seal at the inside of the tissue wall, preventing liquids or other substances to pass through the tissue wall along the outside of the elongated hollow body and the edge of the hole.

According to an embodiment the tensioning member is configured to transition between an insertion state, wherein the tensioning member causes the internal abutment element to move away from the external abutment element, and an anchoring state, wherein the tensioning member causes the internal abutment element and the external abutment element to press against each other.

Since the external abutment member is moveable relative to the elongated hollow body, the external abutment member is also moveable relative to the internal abutment member which is coupled to the elongated hollow body. It is clear to the skilled person that, when the external abutment member is blocked, for example against the tissue wall, the elongated hollow body and the internal abutment member are moveable relative to the external abutment member. In other words, the internal abutment member can move away from the external abutment member, or can move towards the external abutment member. This motion, in both directions, is actuated by the tensioning member. According to an embodiment the at least one deployable element is in the insertion position when the tensioning member is in the insertion state and wherein the at least one deployable element is in the anchoring position when the tensioning member is in the anchoring state. This way, the tension member can control the at least one deployable element to transition from its insertion position, to insert the elongated hollow body in the hole, to its anchoring position when the elongated hollow body is inserted in the hole, i.e. the insertion end has passed through the hole. This way the tensioning member enables a clean insertion of the elongated hollow body through the hole, and a stable anchoring of the access device to the tissue wall after insertion.

According to an embodiment the holding means comprise at least one recess for holding the at least one deployable element in its insertion position.

By providing the holding means with at least one recess that is configured for holding the at least one deployable element in its insertion position, the functionality of the holding means depends on the distance between the external abutment member comprising the holding means and the internal abutment member comprising the at least one deployable element. When the deployable element is in its insertion position in the recess and the distance between the external abutment member and the internal abutment member increases, the deployable element may be lifted out of the recess, thereby causing the deployable element to transition to its anchoring state. The deployable element or elements are preferably made out of an elastic material. The deployable elements can be hold in their insertion position by the holding means, such that the elastic material is under tension when it is hold in the insertion position. When the deployable elements are then released from the holding means, e.g. a recess, the elasticity of the material and the tension will cause the deployable elements to transition to their anchoring state.

According to an embodiment the tensioning member causes the at least one deployable element to move away from external abutment such that the at least one deployable element is removed from the at least one recess when the insertion end of the elongated hollow body is inserted into the hole of the tissue wall.

This way the at least one deployable element may reach its anchoring position after insertion into the hole of the tissue wall. When the elongated hollow body is being inserted into the whole, the external abutment member will at some point be pressed against the tissue wall, preventing the external abutment member to move further along the elongated hollow body, causing the elongated hollow body with the attached internal abutment member and at least one deployable element to move further away from the external abutment member comprising the recess. As described earlier, when the distance between the external abutment member and the internal abutment member increases, the deployable element may be lifted out of the recess or removed therefrom, thereby causing the deployable element to transition out of its insertion position to its anchoring position.

According to an embodiment the at least one deployable element comprise at least one flexible flap. When the at least one deployable element has reached its anchoring position and when the distance between the internal abutment member and the external abutment member is reduced, the at least one deployable element will be pressed against the internal abutment member. In this case the tissue wall will be located between the external abutment member and the at least one deployable element. The at least one flexible flap causes the at least one deployable element to be pressed fittingly against the tissue wall and the external abutment member. This way, an internal seal can be created at the side of the internal abutment member.

According to an embodiment the elongated hollow body is configured for accommodating at the interior thereof an insertion needle to provide the hole in the tissue wall.

This way, a hole can be created in the tissue wall by means of the insertion needle, and the elongated hollow body can be inserted into the hole directly after creation of the hole. When the hole is created, the insertion needle can be removed from the elongated hollow body. According to an embodiment the connection end comprises a connection element configured to provide a connection with an external delivery system of a medical solution.

This way, medication can be administered via the elongated hollow body of the access device. Via the access device, medication can reach places which would otherwise not be accessible, The valve system allows one-way traffic, for example it enables the provision of medication from outside the tissue wall to inside the tissue wall. In addition or alternatively to medication, it is also possible to provide medical equipment via the elongated hollow body of the access device.

According to an embodiment the valve system comprises a hemostatic valve. When the tissue wall is a blood vessel wall, the hemostatic valve within the elongated hollow body will prevent blood from passing through from within the blood vessel to outside the blood vessel.

According to an embodiment the tensioning member comprises at least one spring element.

By using at least one spring element the tensioning member can be compressed, e.g. to push the elongated hollow body through the hole of the tissue wall when the external abutment member is blocked against the tissue wall, and stretched, e.g. to pull the internal abutment member towards the external abutment member when the at least one deployable element is in its anchoring position.

According to an embodiment the at least one spring element is located externally to the elongated hollow body. This way, the space within the elongated hollow body can be reserved for the passing through of medication and/or medical equipment.

According to an embodiment the tensioning member comprises multiple spring elements which are located externally to the hollow body and oriented substantially parallel to the elongated hollow body.

In stead of using one spring element that might be cylindrical and positioned around the elongated hollow body, multiple spring elements can be used which are then each positioned along the elongated hollow body. Depending on the purpose of the access device, one arrangement may be beneficial as compared to the other.

According to an embodiment the access device is a vascular closing device, and the tissue wall is a vessel wall of a blood vessel. This way the access device can be used for example during heart surgery to provide access to the aorta and the heart cavity by inserting the access device through a hole in the aorta wall. The valve system may comprise a hemostatic valve to prevent bleeding. The access device can for example be used to provide cardioplegia or blood perfusion, or to provide access to introduce a heart valve or septal closure device. After the operation the access device stays in place within the aorta wall, where it can be used in case of a second operation or a follow-up check. According to an embodiment the tensioning member is coupled to the elongated hollow body via a support member connected to the elongated hollow body.

This way the movement of the tensioning member can be transferred to the elongated hollow body, to move the elongated hollow body in respect of the external abutment member.

According to an embodiment the support member surrounds the elongated hollow body.

The support member may for example be a support ring or have another shape surrounding the elongated hollow body. This allows for the force of the tensioning member to be transferred to the elongated hollow body in a uniform manner.

According to an embodiment the support member is located between the external abutment member and the connection end.

This way the movement of the elongated hollow body through the hole can be controlled by the tensioning member from outside the tissue wall. Moreover, this way the outside of the elongated hollow tube between the internal abutment member and the external abutment member is kept free from obstructions, such that the elongated hollow body can be smoothly inserted in the hole of the tissue wall without damaging the edges of the tissue wall which surround the hole.

According to an embodiment the support member is located at the connection end.

This way the tensioning member can span the entire distance between the connection end and the external abutment member.

According to an embodiment the tensioning member comprises an elastic band.

Alternative to or in addition to comprising at least one spring element, the tensioning member may comprise and elastic band which is able to draw the internal abutment member towards the external abutment member when the elastic band transfers to its extended state and to move the internal abutment member away from the external member when the elastic band transfers to its compressed state. According to an embodiment the elastic band has the shape of a cylinder which is substantially concentric with the elongated hollow body. This way a firm and compact construction of the tensioning member is provided. In an alternative embodiment the elastic band comprises multiple elements, which are formed by cutting open the barrel of a cylinder along a longitudinal direction of said barrel of the cylinder.

According to an embodiment the at least one flexible flap is made out of metal.

This way the at least one flexible flap is robust and durable, while remaining flexible. It is clear to the skilled person that other materials may be used which offer the same characteristics.

According to an embodiment a diameter of the elongated hollow body is between 1mm and 15mm, preferably between 3mm and 10mm.

This way, the elongated hollow body is suited for providing therethrough a passage for medication or medical equipment.

According to an embodiment a length of the elongated hollow body is between 5mm and 20mm, preferably between 8mm and 16mm, most preferably between 12mm and 14mm. This way, the elongated hollow body is suited to on the one hand guide medical equipment or medication therethrough, while on the other hand these dimensions allow the access device to remain safely anchored to the tissue wall.

Brief description of the figures

The accompanying drawings are used to illustrate presently preferred non-limiting exemplary embodiments of devices of the present invention. The above and other advantages of the features and objects of the invention will become more apparent and the invention will be better understood from the following detailed description when read in conjunction with the accompanying drawings, in which:

Figures 1A-1E illustrate schematically in a cross-sectional view an exemplary embodiment of an access device according to the invention, wherein each figure illustrates the access device in a different phase;

Figures 2A-2C illustrate schematically in a cross-sectional view an alternative embodiment of an access device according to the invention, wherein each figure illustrates the access device in a different phase; Figure 3 illustrates a perspective view of another exemplary embodiment of the access device according to the invention; and

Figure 4 illustrates a perspective view of an alternative exemplary embodiment of the access device according to the invention.

Description of embodiments

Figure 1A illustrates an embodiment of an access device 100 according to the invention and a tissue wall 50, e.g. a wall of an artery. The access device 100 comprises an elongated hollow body 110 in the shape of a cylinder. It is clear to the skilled person that the elongated hollow body 110 may have any other tube-like shape, such that the hollow interior of the elongated hollow body 110 may serve as an access way for medical equipment of medications. The elongated hollow body has an insertion end 111 and a connection end 112. The insertion end 111 is adapted to be inserted through the tissue wall 50 via a hole (not shown in figure 1A). When the tissue wall 50 is for example an aorta wall 50, the insertion end 111 is configured to be positioned at a first side 50a of the aorta wall, corresponding with the inside of the aorta, whereas the connection end is configured to remain at a second side 50b of the aorta wall, corresponding with the outside of the aorta. In the embodiment of figure 1 A, an insertion needle 160 is provided at the insertion end 111 which may be used to puncture a hole 51 in the tissue wall 50, in which hole 51 the access device can then be inserted. The insertion needle 160 is a retractable needle which can easily be provided via the elongated hollow body 110 and afterwards be retracted from the access device 100 as shown in figure IE. At the connection end 112, thus at an outside 50b of the tissue wall when the access device is inserted in the hole 51, there is provided a connection member 170. The connection member 170 is configured to connect to dedicated supply devices (not shown) for the

administration of medication or to connecting parts of medical equipment (not shown) to be introduced in the hole 51 via the elongated hollow body 110 of the access device 100. It is clear to the skilled person that connection members 170 of various types can be attached to the connection end 112 of the elongated hollow body 110.

The access device further comprises anchoring means 120, 130, 140 which are configured to cooperate such that the access device 100 can be stably and firmly anchored on the tissue wall 50 while the elongated hollow body 110 is positioned in the hole 51. These anchoring means 120, 130, 140 comprise an internal abutment member 140 which is located at the side of the insertion end 111. This internal abutment member 140 is configured to provide part of the anchoring functionality at the inside 50a of the tissue wall 50. In figures 1A-1E this internal abutment member 140 is illustrated as comprising one or more deployable elements which are coupled to the elongated hollow body 110. How these deployable elements may deploy will become clear in the further description in relation to figures IB-IE. In figure 1A the deployable elements 140 are being retained in one or more recesses 121 in the external abutment member 120. The deployable elements, at one end thereof, are coupled to the elongated hollow body 110 and, at the other end thereof, are retained in the one or more recesses 121. The external abutment member 120 is configured to provide part of the anchoring functionality at the outside 50b of the tissue wall 50 and is moveably arranged on the elongated hollow body 110. The external abutment member 120 may for example be shaped as a ring. In addition to its anchoring functionality, the external abutment member 120 may also fulfil the role of a sealing ring by sealing the space between the edges of the tissue wall 50 and the exterior of the elongated hollow body 110 at the outside of the tissue wall when the elongated hollow body 110 is positioned in the hole 51 of the tissue wall 50. Tensioning member 130 couples the external abutment member 120 to the elongated hollow body 110. In figure 1 A the tensioning member comprises one or multiple helical springs 130 which are connected to the connection member 170, wherein the connection member is attached to the connection end 112 of the elongated hollow body 110. However, it is clear that the tensioning member, in this case the helical springs 130, may be coupled to the elongated hollow body 110 in various alternative ways. For example the tensioning means 130 may be directly attached to the elongated hollow body 110, or alternatively may be coupled to the elongated hollow body 110 by means of another connecting piece which is attached to the elongated hollow body 110 at the side of the connection end 112. Moreover, it is clear to the skilled person that the tensioning member 130 may be coupled to the elongated hollow body 110 anywhere between the external abutment member 120 and the connection end 112 of the elongated hollow body 110.

At the interior of the elongated hollow body 110 a valve system 150 is provided which is configured to be a one-way valve system, i.e. on the one hand the valve system 150 is configured to block vessel blood or fluid from flowing from inside 50a the tissue wall to outside 50b the tissue wall via the elongated hollow body 110 and, on the other hand, to allow the introduction of medical solution or equipment towards the interior 50a of the vessel at the inside of the tissue wall via the connection end 112 of the elongated hollow body 110. Although a simple embodiment of such a valve system 150 is illustrated, it is clear that any other unidirectional valve system 150 which is able to provide the above described one-way traffic may be used in the access device 100 according to the invention.

The arrow at the right in figure 1A points in the direction in which the entire access device 100 is moving, namely in a direction towards the tissue wall 50. The double arrow on the left indicates the directions of movement of the external abutment member 120 in respect of the elongated hollow body 110. These directions of movement correspond to the extension direction and the compression direction of the tensioning means 130. In figure IB, the access device 100 is shown after the insertion needle has made a hole 51 in the tissue wall 50 and the elongated hollow body 110 has partially passed through the hole 51. The external abutment member 120 has come into contact with the tissue wall 50, e.g. aorta wall, and is thereby blocked. By applying a pressure in the direction of the unidirectional arrow in figure 2A the tensioning springs 130 get compressed and the elongated hollow body 110 further protrudes at the inside 50a of the tissue wall 50. Because of the applied pressure, the internal abutment member 140, which is located at the side of the insertion end 111 moves further away from the external abutment member 120, thereby causing the deployable elements 140 to be released from the holding means 121, in this case the recess 121. Although a recess is used as holding means in this embodiment, it is clear to the skilled person that in alternative embodiments alternative holding means may be applied such a clip, a clamp, a hook, a protrusion or any combination thereof. The deployable elements 140 may be retained in the recess 121 under a particular amount of tension, such that, when the deployable elements are lifted out of the recess, the deployable elements deploy out of their insertion position, wherein they are positioned closely against the elongated hollow body 110, into their anchoring position, wherein they are oriented substantially parallel with the orientation of the external abutment member 120 and/or the tissue wall 50.

Figure 1C illustrates the deployable elements 140 of the internal abutment member when they have reached their anchoring position after deployment. The direction of deployment is indicated by the arrows in figure 1C. When the deployable elements 140 are in their anchoring position, the pressure on the tensioning means 130 is released, which causes the helical springs 130 to extend, thereby pulling the internal abutment member 140 towards the internal abutment member 120, which results in the anchoring means 120, 130 and 140 being in the anchoring state, as illustrated in figure ID. The flaps 140 are opened completely and the tissue or vessel wall is pressed between the flaps 140 and the sealing ring 120.

Figure ID merely schematically illustrates the position and state of the access device 100 and the parts 120, 130, 140 and 150 thereof. Although the deployable elements 140 are illustrated as rigid elements and are shown to enclose a space in between a part of the elongated hollow body 110 and the aorta wall 50, it is clear that the deployable elements may also me made out of a flexible material such that they can be fittingly pressed against the aorta wall 50 and the external abutment member 120.

Figure IE illustrates the same situation as is illustrated in figure ID, with the difference that in figure IE the insertion needle 160 has been removed and the unidirectional valve system 150 has closed to prevent bleeding or leakage. The access device 100 is now ready to be connected to a delivery circuit or system for administering medication for example.

In figures 2A-2C an alternative embodiment of the access device 200 according to the invention is illustrated, wherein the tensioning means 230 comprise elastic flaps 230 in stead of helical springs 130. It is however clear to the skilled person that the tensioning means may comprise alternative spring elements or elastic elements or alternative tensioning elements which provide the same functionality. Figure 2A illustrates the access device 200 with the deployable flaps 241 of the internal abutment member in the insertion position, wherein the deployable flaps 241 are retained in the recess 221 in the external sealing ring 220. The external sealing ring 220 is coupled to a ring shaped support member 280 by means of the elastic flaps 230. The support member 280 may also function as connection member 270 for external delivery systems. In figure 2A the support member 280 is illustrated as being attached to the connection end 212 of the elongated hollow body 210, however, the support member may also be attached to the elongated hollow body anywhere between the connection end 212 and the external sealing ring 220. When the support member 280 is not located at the connection end 212, an additional connection member 270 may be provided. In figure 2B a pressure is applied to the tensioning member 230 which causes the elastic flaps 230 to compress which causes the internal abutment member 240 to move further away from the external sealing ring 220 which is blocked against the vessel wall 250. This way the deployable elements 241 of the internal abutment member 240 are lifted out of the recess 221 of the external sealing ring and the deployable elements 241 are deployed out of their insertion position towards their anchoring position. When the external pressure on the tensioning member 230 is released, the elastic flaps 230 will stretch and will cause the deployable elements 241 of the internal abutment member 240 to be pressed against the vessel wall 50 and the external sealing ring 220. This is illustrated in figure 2C. Figure 2C further illustrates an embodiment wherein the deployable elements 241 are flexible flaps 241, which can be fittingly pressed against the vessel wall 50 at the inside of the vessel.

Throughout figures 2A-2C the valve system 250 is illustrates in a closed state. When the vessel wall or tissue wall 50 is part of a blood vessel such as the aorta, the valve system 250 may comprise a unidirectional hemostatic valve 250 to prevent bleeding through the elongated hollow body 210. Figure 3 illustrates in perspective an embodiment of the access device 300 according to the invention. The access device 300 comprises a hollow cylinder 310 which has an insertion end 311 and a connection end 312. At the insertion end 311 an internal abutment member 340 is provided, which comprises deployable flaps 341. From figure 3 it is clear that the internal abutment member may be constructed out of a hollow cylinder, for example by cutting open the cylinder along its longitudinal axis at several positions to form the flaps 341. The internal abutment member 340 is connected to the hollow cylinder 310. The access device further comprises a sealing ring 320 which is moveably arranged around the hollow cylinder 310. The sealing ring 320 comprises a circular recess 321 in which the deployable flaps 341 can be retained. However, in figure 3 the deployable flaps have already been lifted out of the recess 321. The sealing ring 320 can move along the hollow cylinder 310, or, in other words, the hollow cylinder can move with respect to the sealing ring 320. Moreover, since the internal abutment member 340 is connected to the hollow cylinder 310, the internal abutment member can be moved with respect to the sealing ring 320. The sealing ring 320 is moveably coupled to the hollow cylinder 310 by means of tensioning means 330 and a support ring 380. The support ring 380 is attached to the hollow cylinder 310 and the tensioning means 330, being elastic flaps 330 in figure 3, provide a coupling between the support ring 380 and the sealing ring 320. By compression and stretching of the elastic flaps 330, the sealing ring 320 and internal abutment member 340 can move away from each other or towards each other, respectively. At the connection end 312 if the hollow cylinder 310 a connection member may be provided (not shown) to allow medical equipment to connect to the access device 310, for example by clicking, and be brought through the hollow cylinder 310.

Although the holding means 321 are illustrated as one circular recess 321, it is clear to the skilled person that the holding means may comprise multiple individual recesses, wherein each one of the recesses can accommodate a corresponding deployable element 341 in the insertion position.

Figure 4 illustrates a similar embodiment of an access device 400 as the embodiment of figure 3, with the difference that in figure 4 the support ring 480 is provided at the connection end of the hollow cylinder 410, whereas in figure 3 the support ring 380 is provided between the connection end 312 and the sealing ring 320. The access device 400 in figure 4 comprises a hollow cylinder 410 which has an insertion end 411 and a connection end 412. At the insertion end 411 an internal abutment member 440 is provided, which comprises deployable flaps 441. The internal abutment member 440 is connected to the hollow cylinder 410 at a distance from the insertion end 411. The access device 400 further comprises a sealing ring 420 which is moveably arranged around the hollow cylinder 410 and which is pressed against the internal abutment member 440 and the deployable flaps 441 thereof. In practice there would be a tissue wall such as a vessel wall, aorta wall, gastric wall, etc. pressed between the internal abutment member 440 and the sealing ring 420. The sealing ring 420 can move along the hollow cylinder 410, or, in other words, the hollow cylinder can move with respect to the sealing ring 420. Since the internal abutment member 440 is connected to the hollow cylinder 410, the internal abutment member 440 can be moved with respect to the sealing ring 420. The sealing ring 420 is moveably coupled to the hollow cylinder 410 by means of tensioning means 430 and the support ring 480. The support ring 380 is attached to the hollow cylinder 410 and the tensioning means 430, being elastic flaps 430 in figure 4, provide a coupling between the support ring 480 and the sealing ring 420. By compression and stretching of the elastic flaps 430, the sealing ring 420 and internal abutment member 440 can move away from each other or towards each other, respectively.

Although the internal abutment member 440 is illustrated to comprise multiple deployable elements 441, it is clear to the skilled person that the internal abutment member may alternatively comprise a single deployable element with for example an umbrella-like mechanism.

Although the tensioning member 430 has been illustrated to comprise multiple elastic flaps 430, it is clear to the skilled person that the tensioning member may alternatively comprises a single elastic flap or elastic band or elastic element with for example an accordion-like movement. Moreover, alternatively or in addition the tensioning member 430 may comprise one or more spring elements such as helical springs or coil springs or any other type of springs or combinations thereof. Whilst the principles of the invention have been set out above in connection with specific embodiments, it is to be understood that this description is merely made by way of example and not as a limitation of the scope of protection which is determined by the appended claims.

Claims

1. Access device (100) for placement in a hole (51) in a tissue wall (50), said access device (100) comprising:

- an elongated hollow body (110) having an insertion end (111) and a connection end

(112), said elongated hollow body (110) being configured to be inserted into the hole (51) in the tissue wall (50) such that the insertion end (111) is situated at an inside of the tissue wall and the connection end (112) is situated at an outside of the tissue wall;

- anchoring means configured to anchor the elongated hollow body (110) to the tissue wall (51), the anchoring means comprising:

- an external abutment member (120) moveably arranged around the elongated hollow body (110) between the insertion end (111) and the connection end (112), said external abutment member (120) being configured to surround the hole (51) in the tissue wall (50) at the outside when the insertion end (111) of the elongated hollow body (110) is at the inside;

- a tensioning member (130) coupling the external abutment member (120) to the elongated hollow body (110) at the side of the connection end (112); and

- an internal abutment member (140) arranged at the side of the insertion end (111) of the elongated hollow body (110), wherein the tensioning member (130) is configured to exert a force on the internal abutment member (140) and the external abutment member (120) such that the tissue wall (50) is pressed between the internal abutment member (140) and the external abutment member (120);

- a valve system (150) positioned inside the elongated hollow body (110), between the external abutment member (120) and the connection end (112), said valve system (150) being configured on the one hand to block fluid from flowing outside the elongated hollow body (110) and on the other hand to allow the introduction of medical solution or equipment into the inside of the tissue wall via the connection end (112) of the elongated hollow body (110).

2. Access device (100) according to claim 1, wherein the internal abutment member (140) comprises at least one deployable element which is switchable between an insertion position, wherein the at least one deployable element is oriented substantially parallel with a longitudinal axis of the elongated hollow body (110), and an anchoring position, wherein the deployable element (141) is oriented substantially parallel with the tissue wall (50). 3. Access device (100) according to claim 2, wherein the external abutment member (120) comprises holding means (121) which are configured for holding the at least one deployable element in the insertion position when the insertion end (111) of the elongated hollow body (110) is to be inserted into the hole (51), and for releasing the at least one deployable element (151) to reach its anchoring position when the insertion end (111) of the elongated hollow body (110) is inserted into the hole (51).

4. Access device (100) according to claim 2 or 3, wherein the at least one deployable element is made of a flexible material such that the at least one deployable element, in its anchoring position, is pressed fittingly against the tissue wall by the tensioning member (130). 5. Access device (100) according to any one of the previous claims, wherein the tensioning member (130) is configured to transition between an insertion state, wherein the tensioning member (130) causes the internal abutment element (140) to move away from the external abutment element (120), and an anchoring state, wherein the tensioning member (130) causes the internal abutment element (140) and the external abutment element (120) to press against each other.

6. Access device (100) according to claim 5, wherein the at least one deployable element is in the insertion position when the tensioning member (130) is in the insertion state and wherein the at least one deployable element is in the anchoring position when the tensioning member (130) is in the anchoring state.

7. Access device (100) according to any one of the claims 3 to 6, wherein the holding means (121) comprise at least one recess for holding the at least one deployable element in its insertion position. 8. Access device (100) according to claim 6, wherein the tensioning member (130) causes the at least one deployable element to move away from external abutment (120) such that the at least one deployable element is removed from the at least one recess when the insertion end (111) of the elongated hollow body is inserted into the hole (51) of the tissue wall (50). 9. Access device (100) according to any one of the claims 3 to 8 wherein the at least one deployable element comprise at least one flexible flap.

10. Access device (100) according to any one of the preceding claims, wherein the elongated hollow body (110) is configured for accommodating at the interior thereof an insertion needle to provide the hole (51) in the tissue wall (50).

11. Access device (100) according to any one of the preceding claims, wherein the connection end (112) comprises a connection element (160) configured to provide a connection with an external delivery system of a medical solution. 12. Access device (100) according to any one of the preceding claims, wherein the valve system (150) comprises a hemostatic valve.

13. Access device (100) according to any one of the preceding claims, wherein the tensioning member comprises at least one spring element.

14. Access device (100) according to claim 13, wherein the at least one spring element is located externally to the elongated hollow body.

15. Access device (100) according to claim 13 or 14, wherein the tensioning member comprises multiple spring elements which are located externally to the hollow body and oriented substantially parallel to the elongated hollow body.

16. Access device (100) according to any one of the preceding claims, wherein the access device is a vascular closing device, and wherein the tissue wall is a vessel wall of a blood vessel.

17. Access device (100) according to any one of the preceding claims, wherein said tensioning member is coupled to the elongated hollow body via a support member connected to the elongated hollow body. 18. Access device (100) according to claim 17, wherein the support member surrounds the elongated hollow body.

19. Access device (100) according to claim 17 or 18, wherein the support member is located between the external abutment member and the connection end.

20. Access device (100) according to claim 17 or 18, wherein the support member is located at the connection end.

21. Access device (100) according to any one of the preceding claims, wherein the tensioning member comprises an elastic band.

22. Access device (100) according to claim 21, wherein the elastic band has the shape of a cylinder which is substantially concentric with the elongated hollow body.

23. Access device (100) according to any one of the preceding claims 9 to 22, wherein the at least one flexible flap is made out of metal.

24. Access device (100) according to any one of the preceding claims, wherein a diameter of the elongated hollow body is between 1mm and 15mm, preferably between 3mm and 10mm.

25. Access device (100) according to any one of the preceding claims, wherein a length of the elongated hollow body is between 5mm and 20mm, preferably between 8mm and 16mm, most preferably between 12mm and 14mm.