BE1024992B1 - ACCESS PROVIDING DEVICE - Google Patents

Abstract

An accessing device for placement in an opening in a tissue wall, comprising: an elongated hollow body with an insertion end and a connecting end; anchoring means for anchoring the elongated hollow body to the tissue wall, comprising: an external support element to surround the opening in the tissue wall; a tension member that couples the external support member to the elongated hollow body at the connection end side; and an internal support element arranged at the insertion end side, the tensioning element configured to exert a force on the internal support element and the external support element such that the tissue wall is pressed between the internal support element and the external support element; a valve system to prevent fluid from flowing out of the elongated hollow body, and to allow the introduction of medical equipment into the tissue wall opening through the connecting end.

Description

(30) Priority data:

(73) Holder (s):

ANDOCOR NV 2980, ZOERSEL Belgium (72) Inventor (s):

ROSA Patrick Marie José 2970 SHIELD Belgium

LEMMA Massimo Giovanni 20099 SESTO SAN GIOVANNI Italy (54) ACCESSIBLE DEVICE (57) Access providing device for placement in an opening in a tissue wall, comprising: an elongated hollow body with an insertion end and a connecting end; anchoring means for anchoring the elongated hollow body to the tissue wall, comprising: an external support element to surround the opening in the tissue wall; a tension member that couples the external support member to the elongated hollow body at the connection end side; and an internal support member arranged at the insertion end side, the tension member configured to exert a force on the internal support member and the external support member such that the tissue wall is pressed between the internal support member and the external support member; a valve system to prevent fluid from flowing out of the elongated hollow body, and to allow the insertion of medical equipment into the tissue wall opening through the connecting end.

BELGIAN INVENTION PATENT

FPS Economy, K.M.O., Self-employed & Energy

Intellectual Property Office

Publication number: 1024992 Filing number: BE2017 / 5103

International classification: A61M 39/02 Date of issue: 18/09/2018

The Minister of Economy,

Having regard to the Paris Convention of 20 March 1883 for the Protection of Industrial Property;

Having regard to the Law of March 28, 1984 on inventive patents, Article 22, for patent applications filed before September 22, 2014;

Having regard to Title 1 Invention Patents of Book XI of the Economic Law Code, Article XI.24, for patent applications filed from September 22, 2014;

Having regard to the Royal Decree of 2 December 1986 on the filing, granting and maintenance of inventive patents, Article 28;

Having regard to the application for an invention patent received by the Intellectual Property Office on 20/02/2017.

Whereas for patent applications that fall within the scope of Title 1, Book XI, of the Code of Economic Law (hereinafter WER), in accordance with Article XI.19, § 4, second paragraph, of the WER, the granted patent will be limited. to the patent claims for which the novelty search report was prepared, when the patent application is the subject of a novelty search report indicating a lack of unity of invention as referred to in paragraph 1, and when the applicant does not limit his filing and does not file a divisional application in accordance with the search report.

Decision:

Article 1

ANDOCOR NV, Kwikaard 104, 2980 ZOERSEL Belgium;

represented by

D'HALLEWEYN Nele Veerle Trees Gertrudis, Meir 24 box 17, 2000, ANTWERP;

a Belgian invention patent with a term of 20 years, subject to payment of the annual fees as referred to in Article XI.48, § 1 of the Code of Economic Law, for: ACCESS PROVIDED DEVICE.

INVENTOR (S):

ROSA Patrick Marie José, Catharinadreef 24, 2970, SHIELD;

LEMMA Massimo Giovanni, via Davide Campari 3 / b, 20099, SESTO SAN GIOVANNI;

PRIORITY:

BREAKDOWN:

Split from basic application: Filing date of the basic application:

Article 2. - This patent is granted without prior investigation into the patentability of the invention, without warranty of the Merit of the invention, nor of the accuracy of its description and at the risk of the applicant (s).

Brussels, 18/09/2018,

With special authorization:

BE2017 / 5103

Access Providing Device

Field of the invention

The art of the invention relates to an access-providing device for placement in an opening in a tissue wall. Certain embodiments pertain to the art of an access device for use in minimally invasive surgical procedures.

Background

During minimally invasive surgery (MIS), a small incision is made in a tissue wall to make a small hole or opening in the tissue wall through which surgical instruments or medical solutions can be delivered to a more distant area of interest, for example, through a cannula. Compared to patients undergoing conventional surgery that have relatively large openings to reach an area of interest, MIS patients recover faster and experience less discomfort.

An example of a minimally invasive surgical procedure is cardiac surgery in which a central cannula is performed in combination with a tobacco pouch suturing technique. Typically, different types of cannulas such as arterial, cardioplegic, venous, and aeration cannulas are inserted into the blood vessel or heart and mechanically blocked by a single or double tobacco pouch suture. The tobacco pouch suture prevents air from entering the cardiovascular system and prevents bleeding. Furthermore, the tobacco pouch suture is used to close the insertion opening when the cannula has been withdrawn from the blood vessel.

Summary

During minimally invasive surgical procedures, the space to maneuver surgical Instruments is very limited, and preparing a tobacco pouch suture is a difficult, error prone and time consuming task. When the cannula is removed from the incision opening, leaks or bleeding may develop through the incision opening. In such a case it is necessary to add an additional bond to ensure a good closure.

The object of embodiments of the invention is to provide an access-providing device that no longer needs the assistance of tobacco pouch sutures or sutures to mechanically block the device to prevent leakage and / or bleeding, respectively.

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According to a first aspect of the invention, an access-providing device is provided for placement in an opening in a tissue wall. The accessing device includes an elongated hay body with an insertion end and a connecting end, the elongated hollow body being configured to be inserted into the opening in the tissue wall so that the insertion end is at an interior of the tissue wall and the connection end at an outside of the tissue wall. The accessing device further comprises anchoring means configured to anchor the elongated hollow body to the tissue wall, the anchoring means comprising an external support member movably arranged around the elongated hollow body between the insertion end and the connecting end, the external support element being configured to surround the opening in the tissue wall on the outside when the insertion end of the elongated hollow body is on the inside; a tension member that couples the external support member to the elongated hollow body at the connection end side; and an internal support member arranged at the insertion end side of the elongated hollow body, the tension member configured to apply a force to the internal support member and the external support member such that the tissue wall between the internal support member and the external support member is pressed. The accessing device comprises a valve system positioned within the elongated hollow body, between the external support member and the connecting end, the valve system being configured to prevent liquid from elongating the hollow body on the one hand, and to introduce a medical solution on the other or equipment to allow the interior of the tissue wall through the connecting end of the elongated hollow body.

Embodiments of the invention are based, inter alia, on the understanding that the anchoring means provide mechanical stability to the accessing device by connecting the elongated hollow body to the tissue wall and securing the elongated hollow body to the tissue wall when the elongated hollow body is inserted into the opening of the tissue wall. In this way, it is not necessary to perform a tobacco pouch suture or use any other separate tool to immobilize the accessing device in the opening. The external support member is movable along the elongated hollow body at the outside of the tissue wall and can be positioned against the edge of the opening of the tissue wall to surround the opening and to accommodate the space between the outside of the elongated hollow body and the edge of the close the opening. In this way, no substances can be exchanged between the inside and the outside of the tissue wall, except through the inside of the elongated hollow body

BE2017 / 5103 when the valve system permits. When the external support member is in the closure position, and the insertion end of the elongated hollow body, together with the internal support member is located at the inside of the tissue wall, the tension member applies a force to both the internal and external support members. elements are pressed together with in between the tissue wall. Since the tension member exerts this force on the external and internal support member, the accessing device is stably anchored to the tissue wall and the elongated hollow body is securely positioned in the opening in the tissue wall. In this manner, medical equipment can be reliably inserted into the opening through the elongated hollow body of the accessing device.

Furthermore, the valve system prevents liquids or other substances from moving from one side of the tissue wall to the other or leaking through the elongated hollow body. The accessing device should not be removed from the opening but can remain there as a sealing device, eliminating the need for sutures or tobacco pouch sutures to close the opening. The disclosed accessing device has the functionality to allow medical equipment or medical solutions to be introduced through the opening through the elongated hollow body and the one-way valve system. However, when no medical equipment is introduced through the elongated hollow body, the valve system closes and the accessing device has the functionality of a sealing device that closes the opening in the tissue wall and prevents any exchange through the opening. Furthermore, the route can be reused through the elongated hollow body if necessary. This may be advantageous, for example, to perform a check of a minimally invasive surgical procedure performed some time after the minimally invasive surgical procedure has been performed. In other words, the access device described above functions both as an access device to allow easy access for medical equipment and / or medicaments, and as a closure device to close and seal the opening in the tissue wall to prevent leakage and / or prevent bleeding. Thus, the disclosed accessing device can provide access to the vessels or hohes of a human body and can supply fluids, but can also be used to deliver an implantable device.

In one embodiment, the internal support member includes at least one expandable member that is switchable between an insertion position, the at least one expandable member oriented substantially parallel to a longitudinal axis of the elongated hollow body, and an anchoring position, the expandable member substantially oriented parallel to the tissue wall.

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

In one embodiment, the external support member includes holding means configured to hold the at least one deployable member in the insertion position when the insertion end of the elongated hollow body is to be inserted into the opening, and to release the at least one deployable member to reach its anchoring position when the insertion end of the elongated hollow body is inserted into the opening.

The retaining means prevents the at least one deployable member from deploying and reaching its anchoring position before the insertion end has passed through the opening and is located on the inside of the tissue wall. In this manner, the at least one expandable element of the internal support member remains in the insertion position at least until the insertion end has passed through the opening, allowing a neat passage through the opening.

According to an embodiment, the at least one expandable element is made of a flexible material such that the at least one expandable element, in its anchoring position, is pressed appropriately against the fabric wall by the tensioning element.

When the at least one expandable element is pressed against the external support element by means of the tensioning element, with the tissue wall positioned therebetween, the at least one expandable element together with the external support element provides an anchoring function. Furthermore, because of the flexible properties of the at least one expandable element, the external support element can also function as a barrier at the inside of the tissue wall, preventing liquids or other substances from passing through the

BE2017 / 5103 fabric wall pass along the outside of the elongated hollow body and the edge of the opening.

In one embodiment, the tension member is configured to transition between an insertion state, the tension member causing the internal support member to move away from the external support member, and an anchoring condition, the tension member urging the internal support member and the external support member together.

Because the external support element is movable relative to the elongated hollow body, the external support element is also movable relative to the internal support element which is coupled to the elongated hollow body. It is clear to the person skilled in the art that when the external support element is blocked, for example against the fabric wall, the elongated hollow body and the internal support element are movable with respect to the external support element. In other words, the internal support element can move away from the external support element or can move towards the external support element. This movement, in both directions, is controlled by the tensioning element.

According to an embodiment, the at least one deployable element is in the insertion position when the tensioning element is in the insertion state and the at least one deployable element is in the anchoring position when the tensioning element is in the anchoring state.

In this way, the tension member can drive the at least one expandable member to transition from the insertion position, to insert the elongated hollow body into the opening, to the anchoring position when the elongated hollow body is inserted into the opening, this is when the insertion end has passed through the opening. In this way, the tensioning element ensures a neat insertion of the elongated hollow body through the opening and a stable anchoring of the accessing 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 expandable element in its insertion position.

By providing the holding means with at least one recess configured to hold the at least one deployable element in its insertion position, the functionality of the holding means depends on the distance between the external support element including the holding means and the internal support element comprising the at least one

BE2017 / 5103 expandable element. When the expandable element is in its insertion position in the recess and the distance between the external support element and the internal support element increases, the expandable element can be lifted out of the recess causing the expandable element to transition to its anchoring position. The expandable element or elements are preferably made of an elastic material. The expandable elements can be held in their insertion position by means of the holding means such that the elastic material is under tension when it is held in the insertion position. When the expandable elements are subsequently released by the retaining means, for example a recess, the elasticity of the material and the tension will cause the expandable elements to transition to their anchoring condition.

In one embodiment, the tension member moves the at least one expandable member away from the external support member such that the at least one expandable member is removed from the at least one recess when the insertion end of the elongated hollow body is inserted into the opening of the tissue wall .

In this way, the at least one expandable element can reach the anchoring position after insertion into the opening of the tissue wall. When the elongated hollow body is inserted into the opening, the external support element will be pressed against the tissue wall at some point, preventing the external support element from moving further along the elongated hollow body, thereby providing the elongated hollow body with the attached internal support member and at least one expandable member move further away from the external support member with the recess. As previously described, the expandable element will be lifted or removed from the recess as the distance between the external support element and the internal support element increases, causing the expandable element to transition from the insertion position to the anchoring position.

According to an embodiment, the at least one expandable element comprises at least one flexible flap.

When the at least one expandable element has reached its anchoring position and when the distance between the internal support element and the external support element decreases, the at least one expandable element will be pressed against the internal support element. In this case, the fabric wall will be between the external support member and the at least one deployable member. The at least one flexible flap ensures that the at least one expandable element

BE2017 / 5103 is pressed appropriately against the fabric wall and the external support element. In this way, an internal closure can be created on the side of the internal support element.

In one embodiment, the elongated hollow body is configured to accommodate an insertion needle at its interior to make an opening in the tissue wall.

In this way, an opening can be created in the tissue wall by means of an insertion needle, and the elongated hollow body can be inserted into the opening immediately after creation of the opening. When the opening is made, the insertion needle can be removed from the elongated hollow body.

In one embodiment, the connector end includes a connector element configured to connect to an external medical solution delivery system.

In this manner, medication can be administered through the elongated hollow body of the accessing device. The accessing device allows medication to reach places that would otherwise be inaccessible. The valve system allows one-way traffic, for example, allowing medication to be delivered from outside the tissue wall to inside the tissue wall. In addition to, or alternative to, medication, it is also possible to deliver medical equipment through the elongated hollow body of the accessing device.

In one embodiment, the valve system includes a hemostatic valve.

When the tissue wall is a blood vessel wall, the hemostatic valve inside the elongated hollow body will prevent blood from moving inside the blood vessel out of the blood vessel.

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

By using at least one spring element, the tension element can be compressed, for example to push the elongated hollow body through the opening of the tissue wall when the external support element is blocked against the tissue wall, and to stretch

BE2017 / 5103, for example, to pull the internal support member toward the external support member when the at least one deployable member is in its anchoring position.

According to an embodiment, the at least one spring element is outside the elongated hollow body.

In this way, the space within the elongated hollow body can be kept free for the passage of medication and / or medical equipment.

According to an embodiment, the tensioning element comprises a plurality of spring elements which are outside the elongated hollow body and which are oriented substantially parallel to the elongated hollow body.

Instead of using one spring element which can be cylindrical and placed around the elongated hollow body, multiple spring elements can be used, each of which is positioned along the elongated hollow body. Depending on the purpose of the accessing device, a particular device may be more economical compared to another device.

In one embodiment, the access device is a vascular closure device and the tissue wall is a vessel wall of a blood vessel.

In this manner, the accessing device can be used, for example, during cardiac surgery to access the aorta and heart cavity by inserting the accessing device through an opening in the aortic wall. The valve system may include a hemostatic valve to prevent bleeding. The access device may be used, for example, to perform cardioplegia or blood perfusion, or to provide access to insert a hard valve or septal closure device. After surgery, the access device remains at its peak in the aortic wall, where it can be used in the case of a second surgery or a follow-up surgery.

According to an embodiment, the tensioning element is coupled to the elongated hollow body via a support element which is connected to the elongated hollow body.

BE2017 / 5103

In this way, movement of the tensioning element can be transferred to the elongated hollow body to cause the elongated hollow body to move relative to the external support element.

According to an embodiment, the support element surrounds the elongated hollow body.

The support element can for instance be a support ring or have a different shape and surround the elongated hollow body. This allows the force of the tensioning element to be transferred uniformly to the elongated hollow body.

According to an embodiment, the support element is located between the external support element and the connecting end.

In this way, the movement of the elongated hollow body through the opening can be controlled by the tensioning element from the outside of the tissue wall. Furthermore, in this way, the exterior of the elongated hollow burs between the internal support member and the external support member can be kept free from obstructions such that the elongated hollow body can be smoothly inserted into the opening of the tissue wall without the edges of the tissue wall being damage the opening surrounded.

In one embodiment, the support member is located at the connecting end.

In this way, the tensioning element can span the full distance between the connecting end and the external support element.

According to an embodiment, the tensioning element comprises an elastic band.

Alternatively to, or in addition to including at least one spring member, the tension member may comprise an elastic band capable of pulling the internal support member towards the external support member when the elastic band changes to the stretched state, and to move the internal support member away from the external support member when the elastic band transitions to its compressed state.

In one embodiment, the elastic band has the shape of a cylinder that is substantially concentric with the elongated hollow body.

BE2017 / 5103

In this way, a sturdy and compact construction of the tensioning element can be provided. In an alternative embodiment, the elastic band comprises a plurality of elements formed by cutting open a jacket of a cylinder along a longitudinal direction of that jacket of the cylinder.

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

In this way, the at least one flexible flap is robust and durable while also remaining flexible. It is clear to the skilled person that other materials can be used that have the same properties.

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

In this way, the elongated hollow body is suitable for providing a passage therethrough for medication or medical equipment.

According to an embodiment, a length of the elongated hollow body is between 5 mm and 20 mm, preferably between 8 mm and 16 mm, most preferably between 12 mm and 14 mm.

In this manner, the elongated hollow body is suitable for passing medical equipment or medication therethrough while, on the other hand, these dimensions allow the access device to remain securely anchored in the tissue wall.

Brief description of the figure

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

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

Figures 2A-2C schematically show in cross-sectional view an alternative embodiment of an access-providing device according to the invention, each figure representing the access-providing device in a different phase;

BE2017 / 5103

Figure 3 shows a perspective view of another exemplary embodiment of the access-providing device according to the invention; and

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

Figure description

Figure 1A shows an embodiment of an accessing device 100 according to the invention and a tissue wall 50, for example an artery wall. The accessing device 100 includes an elongated hollow body 110 in the form of a cylinder. It is apparent to those skilled in the art that the elongated hollow body 110 can have any other tubular shape, so that the hollow interior of the elongated hollow body 110 can serve as an entryway for medical equipment or medications. The elongated hollow body has an insertion end 111 and a connecting end 112. The insertion end 111 is adapted to be inserted through the tissue wall 50 through an opening (not shown in Figure 1A). For example, when the tissue wall 50 is an aortic wall 50, the insertion end 111 is configured to be positioned at a first side 50a of the aortic wall, which corresponds to the interior of the aorta, while the connecting end is configured to be attached to a second side 50b of the aorta. aortic wall, which corresponds to the outside of the aorta. In the embodiment of Figure 1A, an insertion needle 160 is provided at the insertion end 111 that can be used to pierce an opening 51 into the tissue wall 50, into which opening 51 the accessing device can then be inserted. The insertion needle 160 is an extendable needle which can be easily supplied through the elongated hollow body 110 and subsequently retracted from the accessing device 100 as shown in Figure IE. At the connecting end 112, i.e. at an outside 50b of the tissue wall when the accessing device is inserted into the opening 51, a connecting element 170 is provided. The connecting member 170 is configured to connect to dedicated drug delivery devices (not shown) or to medical device connecting members (not shown) to be inserted into the opening 51 through the elongated hollow body 110 of the accessing device device 100. It is obvious to those skilled in the art that connecting elements 170 of various types can be attached to the connecting end 112 of the elongated hollow body 110.

The accessing device further comprises anchoring means 120, 130, 140 configured to cooperate such that the accessing device 100 can be stably and securely anchored in the tissue wall 50 while the elongated hollow body 110 is positioned in the opening 51. These anchoring means 120, 130, 140

BE2017 / 5103 include an internal support member 140 located at the insertion end 111. This internal support member 140 is configured to provide some of the anchoring functionality at the interior 50a of the tissue wall 50. In Figures 1A-1E, this internal support element is shown as comprising one or more expandable elements coupled to the elongated hollow body 110. How these expandable elements can unfold will become apparent in the further description with reference to Figures 1B-1E. In Figure 1A, the expandable elements 140 are held in one or more recesses 121 in the external support element 120. The expandable elements, at one end thereof, are coupled to the elongated hollow body 110 and, at the other end thereof, are held in the one or more recesses 121. The external support element 120 is configured to provide some of the anchoring functionality at the outside 50b of the fabric wall 50 and is movably arranged on the elongated hollow body 110. The external support element 120 may be formed, for example, as a ring . In addition to its anchoring functionality, the external support member 120 may also perform the rot of a sealing ring by sealing the space between the edges of the tissue wall 50 and the outside of the elongated hollow body 110 at the outside of the tissue wall when the elongated hollow body 110 is located in the opening 51 of the tissue wall 50. Tensioning element 130 couples the external support element 120 to the elongated hollow body 110. In Figure 1A, the tensioning element comprises one or more coil springs 130 connected to the connecting element 170, the connecting element being attached to the connecting end 112 of the elongated hollow body 110. however, it is clear that the tensioning element, in this case the coil springs 130, can be coupled to the elongated hollow body 110 in various alternative ways. For example, the tensioning element 130 can be directly connected to the elongated hollow body 110, or alternatively be coupled to the elongated hollow body 110 by means of another connecting piece arranged on the elongated hollow body 110 at the side of the connecting end 112. It is further apparent to those skilled in the art that the tension member 130 is located anywhere between the external support element 120 and the connecting end 112 of the elongated hollow lic the body 110 may be coupled to the elongated hollow body 110.

At the inside of the elongated hollow body 110 is provided a valve system 150 configured to be a unidirectional valve system, on the one hand, the valve system 150 is configured to prevent blood from the blood vessel or fluid from within 50a the tissue wall from flowing out 50b the tissue wall via the elongated hollow body 110 and, on the other hand, to enable the introduction of a medical solution or material to the inside 50a of the (blood) vessel at the inside of the tissue wall via the connecting end 112 of the elongated hollow body 110. that a simple embodiment of such a valve system is shown, it is obvious that any other

BE2017 / 5103 unidirectional valve system 150 capable of providing the unidirectional transport described above can be used in the accessing device 100 of the invention. The right-hand arrow in Figure 1A points in the direction in which the full access device 100 moves, namely, in a direction toward the tissue wall 50. The double arrow on the left indicates the directions of movement of the external support element 120 relative to the elongated hollow body 110. These directions of movement correspond to the stretching direction and the pressing direction of the tensioning element 130.

In Figure 1B, the accessing device 100 is shown after the insertion needle has made an opening 51 in the tissue wall 50 and the elongated hollow body 110 has partially passed through the opening 51. The external support member 120 has come into contact with the tissue wall 50, for example an aortic wall, and is thereby blocked. By applying a pressure in the direction of the unidirectional arrow, the tension springs 130 are compressed and the elongated hollow body 110 extends further at the inner side 50a of the tissue wall 50. Due to the applied pressure, the internal support element 140 moves, which is at the side from the insertion end 111, further away from the external support member 120, releasing the expandable members 140 from the retaining members 121, in this case the recess 121. Despite using a recess as retaining means in this embodiment, it is obvious skilled in the art that alternative holding means may be used in alternative embodiments, such as a clip, a clamp, a hook, a bulge or any combination thereof. The expandable elements 140 can be retained in the recess 121 under a certain amount of tension such that, when the expandable elements are lifted out of the recess, the expandable elements are positioned out of their insertion positions, in which they are positioned close to the elongated hollow body 110, deploy to their anchoring position, being oriented substantially parallel to the orientation of the external support member 120 and / or the tissue wall 50.

Figure 1C shows the expandable elements 140 of the internal support element when they have reached their anchoring position after deployment. The direction of deployment is indicated by the arrows in Figure 1C. When the expandable elements 140 are in their anchoring position, the pressure on the tensioning elements 130 is released, causing the coil springs 130 to stretch, thereby pulling the internal support element 140 toward the internal support element 120, resulting in the anchoring means 120, 130 and 140 are in the anchoring state, as shown in Figure ID. The flaps 140 are fully opened and the tissue or vessel wall is pressed between the flaps 140 and the sealing ring 120.

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Figure ID only schematically shows the position and condition of the accessing device 100 and parts 120, 130, 140 and 150 thereof. Although the expandable elements 140 are shown as rigid elements and they enclose a space between a portion of the elongated hollow body 110 and the aortic wall 50, it is clear that the expandable elements may also be made of a flexible material such that they subsequently can be pressed against aortic wall 50 and external support member 120.

Figure IE shows the same situation as shown in Figure ID, except that in Figure IE the insertion needle 160 has been removed and the one way valve system 50 is closed to avoid bleeding or leakage. The accessing device 100 is now ready to become Verbünden with, for example, a delivery circuit or system for administering medication.

In Figures 2A-2C, an alternative embodiment of the accessing device 200 according to the invention is shown, in which the tension members 230 comprise elastic Haps 230 instead of coil springs 130. However, it is obvious to those skilled in the art that the tension means include alternative spring elements or elastic elements or may include alternative voltage elements that provide the same functionality.

Figure 2A shows the accessing device 200 with the expandable Haps 241 of the internal support member in the insertion position, with the expandable Haps held in the recess 221 in the external sealing ring 220. The external sealing ring 220 is coupled to an annular support member 280 by of the elastic Happen 230. The support element 280 can also function as connecting element 270 for external delivery systems. In Figure 2A, the support member 280 is shown as being attached to the connecting end 212 of the elongated hollow body 210, however, the support member may also be attached to the elongated hollow body at any other location between the connection end 212 and the external sealing ring 220. When the support member 280 is not at the connecting end 212, an additional support member 270 may be provided.

In Figure 2B, a pressure is exerted on the tension member 230 causing the elastic tabs 230 to compress resulting in the internal support member 240 moving further away from the external sealing ring 220 which is blocked against the vessel wall 250. In this way, the expandable members 241 of the internal support member 240 is lifted from the recess 212 of the external sealing ring and the deployable members 241 are deployed from their insertion position to their anchoring position. When the external pressure on the tension members 230 disappears, the

BE2017 / 5103 stretch elastic Happen 230 and cause the expandable elements 241 of the internal support element 240 to be pressed against the vessel wall 50 and the external sealing ring 220. This is shown in Figure 2C.

Figure 2C further shows an embodiment in which the expandable members 241 are flexible Happen 241 that can be appropriately pressed against the vessel wall 50 at the interior of the blood vessel. In Figures 2A-2C, the valve system 250 is shown 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 include a hemostatic one-way valve to prevent bleeding through the elongated hollow body 210.

Figure 3 is a perspective view of an embodiment of the accessing device 300 according to the invention. The accessing device 300 includes a hollow cylinder 310 having an insertion end 311 and a connection end 312. At the insertion end 311, an internal support member 340 is provided which includes expandable tabs 341. From Figure 3 it is clear that the internal support element can be made from a hollow cylinder, for example by cutting the cylinder along its longitudinal axis at various locations to form the Happen 341. The internal support member 340 is connected to the hollow cylinder 310. The accessing device further includes a sealing ring 320 movably disposed about the hollow cylinder 310. The sealing ring 320 includes a circular recess 321 in which the expandable tabs 341 can be held. However, in Figure 3, the expandable Happen 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 relative to the sealing ring 320. Since the internal support element 340 is connected to the hollow cylinder 310, the internal support element can move relative to the sealing ring 320 are moved. The sealing ring 320 is movably coupled to the hollow cylinder 310 by means of tension means 330 and a support ring 380. The support ring 380 is attached to the hollow cylinder 310 and the tension means 330, being elastic caps 330 in Figure 3, provide a coupling between the support ring and the sealing ring 320. By compressing and stretching the elastic tabs 330, the sealing ring 320 and the internal support member 340 can move away from or move towards each other, respectively. At the connecting end 312 of the hollow cylinder 310, a connecting element (not shown) may be provided to allow medical equipment to be connected to the accessing device 300, for example, by a snap system, and to be inserted through the hollow cylinder 310.

Although the retaining means 321 are shown as one circular recess 321, it is obvious to those skilled in the art that the retaining means may have multiple individual recesses

BE2017 / 5103 wherein each of the recesses can accommodate a corresponding expandable member 341 in the insertion position.

Figure 4 shows a similar embodiment of an accessing device 400 to the embodiment of Figure 3, except that in Figure 4 the support ring 480 is provided at the connecting end of the hollow cylinder 410, while in Figure 3 the support ring 380 is provided between the connecting end 312 and the sealing ring 320. The accessing device 400 in Figure 4 includes a hollow cylinder 410 having an insertion end 411 and a connection end 412. At the connecting end 411, an internal support member 440 is provided which includes expandable Happen 441. The internal support member 440 is connected to the hollow cylinder 410 at a distance from the insertion end 411. The accessing device 400 further includes a sealing ring 420 movably disposed about the hollow cylinder 410 and pressed against the internal support member 440 and the expandable Happen 441 thereof. In practice, there would be a tissue wall such as a vessel wall, aortic wall, stomach wall, etc. pressed between the internal support 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. moving relative to the sealing ring 420. Since the internal support element 440 is connected to the hollow cylinder 410, the internal supporting element 440 can be moved relative to the sealing ring 420. The sealing ring 420 is movably coupled to the hollow cylinder 410 by means of tension means 430 and the support ring 480. The support ring 480 is attached to the hollow cylinder 410 and the tension means 430, being elastic Happen 430 in Figure 4, provide a coupling between the support ring 480 and the sealing ring 420. By compression and stretching of the elastic Happen 430 , the sealing ring 420 and the internal support member 440 may move away from or move towards each other, respectively.

While the internal support member is shown to include multiple expandable elements 441, it is apparent to those skilled in the art that the internal support element may alternatively comprise a single expandable element such as an umbrella-like mechanism.

Despite the tension member 430 being shown to include multiple elastic tabs 430, it is apparent to those skilled in the art that the tension member may alternatively comprise a single elastic flap or elastic band or elastic member with, for example, an accordion-like movement.

Alternatively, or in addition, the tension member 430 may include one or more spring elements such as coil springs or coil springs or any other type of springs or combinations thereof.

BE2017 / 5103

While the principles of the invention have been described above with reference to specific embodiments, it will be understood that the description is made by way of example only and not as limiting the scope of protection defined by the appended claims.

BE2017 / 5103

Claims (20)

Conclusions An access device (100) for placement in an opening (51) in a tissue wall (50), the access device (100) comprising: an elongated hay body (110) with an insertion end (111) and a connecting end (112), the elongated hollow body (110) configured to be inserted into the opening (51) in the tissue wall (50) such that the insertion end (111) located at an inner side of the tissue wall and the connecting end (112) located at an outer side 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 support member (120) movably arranged around the elongated hollow body (110) between the insertion end (111) and the connecting end (112), the external support member (120) configured to open the opening (51) in the tissue wall ( 50) surrounded on the outside when the insertion end (111) of the elongated hollow body (110) is on the inside; a tension member (130) that couples the external support member (120) to the elongated hollow body (110) at the side of the connecting end (112); and an internal support member (140) arranged at the insertion end side (111) of the elongated hollow body (110), the tension member (130) being configured to exert a force on the internal support member (140) and the external support element (120) such that the tissue wall (50) is pressed between the internal support element (140) and the external support element (120); a valve system (150) positioned within the elongated hollow body (110), between the external support member (120) and the connecting end (112), the valve system (150) being configured on the one hand to prevent liquid from the elongated hollow body (110), on the other hand, to allow the introduction of medical solution or equipment to the interior of the tissue wall through the connecting end (112) of the elongated hollow body (110). The accessing device (100) according to claim 1, wherein the internal support member (140) comprises at least one deployable member switchable between an insertion position, the at least one deployable member substantially parallel to a longitudinal axis of the elongated hollow body (110) is oriented, and an anchoring position, wherein the expandable element (141) is oriented substantially parallel to the tissue wall (50). BE2017 / 5103 The access providing device (100) of claim 2, wherein the external support member (120) includes holding means (121) configured to hold the at least one deployable member in the insertion position when the insertion end (111) of the elongated hollow body (110) will be inserted into the opening (51), and for releasing the at least one expandable member (151) to reach its anchoring position when the insertion end (111) of the elongated hollow body (110) is inserted in the opening (51). The access providing device (100) according to claim 2 or 3, wherein the at least one deployable member is made of a flexible material such that the at least one deployable member, in its anchoring position, is pressed snugly against the tissue wall by the tension member (130). The accessing device (100) according to any of the preceding claims, wherein the tension member (130) is configured to transition between an insertion state, the tension member (130) moving the internal support member (140) away from the external support member ( 120), and an anchoring condition, wherein the tension member (130) urges the internal support member (140) and the external support member (120) together. The access providing device (100) of claim 5, wherein the at least one deployable member is in the insertion position when the tension member (130) is in the insertion state and the at least one deployable member is in the anchoring position when the clamping element (130) is in the anchoring condition. The access providing device (100) according to any one of claims 3 to 6, wherein the holding means (121) includes at least one recess for holding the at least one deployable element therein in its insertion position. The access providing device (100) of claim 6, wherein the tension member (130) causes the at least one deployable member to move away from the external support member (120) such that the at least one deployable member is removed from the at least one recess when the insertion end (111) of the elongated hollow body is inserted into the opening (51) of the tissue wall (50). BE2017 / 5103 The access providing device (100) according to any one of claims 3 to 8, wherein the at least one deployable member comprises at least one flexible flap. The accessing device (100) according to any of the preceding claims, wherein the elongated hollow body (110) is configured to accommodate an insertion needle at its interior to provide an opening (51) in the tissue wall (50). The access providing device (100) according to any of the preceding claims, wherein the connecting end (112) comprises a connecting element (160) configured to provide a connection to an external medical solution delivery system. The access providing device (100) according to any of the preceding claims, wherein the valve system (150) comprises a hemostatic valve. The access providing device (100) according to any of the preceding claims, wherein the tensioning element comprises at least one spring element. The access providing device (100) of claim 13, wherein the at least one spring element is outside the elongated hollow body. The access providing device (100) of claim 13 or 14, wherein the tension member includes a plurality of spring members located outside the hollow body and oriented substantially parallel to the elongated hollow body. The access device (100) according to any of the preceding claims, wherein the access device is a vascular closure device, and the tissue wall is a blood vessel vessel wall. The access providing device (100) according to any of the preceding claims, wherein the tension member is coupled to the elongated hollow body via a support member connected to the elongated hollow body. The access providing device (100) of claim 17, wherein the support member surrounds the elongated hollow body. BE2017 / 5103 The access providing device (100) of claim 17 or 18, wherein the support member is located between the external support member and the connecting end. The access providing device (100) according to claim 17 or 18, wherein the support member 5 is located at the connection end. The access providing device (100) according to any of the preceding claims, wherein the tensioning element comprises an elastic band. 10 The access providing device (100) of claim 21, wherein the elastic band is in the form of a crimp which is substantially concentric with the elongated hollow body. The access providing device (100) according to any of the preceding claims 9 to 22, wherein the at least one flexible flap is made of metal. The access providing device (100) according to any of the preceding claims, wherein a diameter of the elongated hollow body is between 1mm and 15mm, preferably between 3mm and 10mm rs. An access providing 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 rs. BE2017 / 5103