Medical lock arrangement and medical set

Abstract

The invention relates to a medical lock arrangement for providing access to a vessel or hollow organ through the vessel wall or organ wall thereof, comprising a retaining arrangement which can be fixed to the vessel wall or organ wall, and a tube which has a connecting flange on the distal side for detachably fixed and fluid-tight joining to the retaining arrangement. The invention is characterised in that the tube has a tube wall through which at least one access channel projects laterally with respect to the longitudinal extent of the tube, through which access channel at least one inflatable body can be introduced into the tube and can be filled with and emptied of a medium, or an inflatable body arranged in the tube wall can be filled with and emptied of a medium, and in that the inflatable body is designed in such a way that, in the filled state, the inflatable body rests against the entire circumference of an inner tube wall which can be allocated to the tube, and can seal the tube fluid-tightly in the longitudinal extent of the tube.

Description

[0001] Medical airlock setup and medical kit

[0002] Technical field

[0003] The invention relates to a medical access device for creating access to a vessel or hollow organ through its vessel or organ wall, comprising a holding device that can be fixed to the vessel or organ wall and a tube that has a connecting flange on its distal side for detachably secure and fluid-tight attachment to the holding device. Furthermore, a medical set for creating an opening in a vessel or hollow organ is described.

[0004] Ventricular assist devices (LVADs), most commonly left ventricular assist devices, are implanted in patients with end-stage heart failure whose ventricular output into the systemic circulation (less frequently the pulmonary circulation) is reduced. Conventional VADs essentially consist of an inflow cannula, which usually directs blood from the left ventricle to the heart pump at the apex of the heart, the heart pump itself, and an outflow vascular prosthesis, which typically carries the blood to the aorta near the heart. To insert the inflow cannula into the ventricle, it is necessary to cut or punch an opening in the apex of the heart (a process known as coring), and subsequently to attach the inflow cannula and the heart pump to the heart wall, protruding through or into this opening.

[0005] Conventional techniques for VAD implantation involve the use of a heart-lung machine (HLM). However, this technique has numerous disadvantages, as venous and arterial cannulation are required for HLM operation, and its operation is complex and associated with many potential complications. State of the art

[0006] To prevent blood from leaking out of the heart chamber through the punched opening in the heart wall (bleeding) and air from entering (air embolism) during VAD implantation, precautions must be taken to seal both the coring procedure and the insertion or attachment of the heart pump's inflow cannula to the heart wall.

[0007] The publication EP 355 1247 A1 discloses an arrangement for attaching and removing a heart pump, comprising a sleeve that is fixed in an opening in the wall of the heart chamber. To prevent uncontrolled blood leakage from the heart through the sleeve to the outside, the sleeve has a sealing element in its lumen in the form of a flap valve, the seat of which is inclined at 45° to facilitate the passage of a medical device, e.g., a heart pump, and at the same time prevent the escape of blood in the opposite direction. The valve thus acts as a check valve.

[0008] Document US 2021 / 0205603 A1 describes a medical device for anchoring a heart pump in an opening of a heart chamber wall. The device comprises a mounting flange with a central opening for attachment to the outer wall of the heart, and a sleeve assembly that can be attached to the mounting flange. Within this sleeve, a silicone anti-reflux valve is inserted to prevent uncontrolled blood leakage from the heart.

[0009] Patent application US 2022 / 0395680 A1 discloses a medical device for anchoring a heart pump in an opening of a heart chamber wall, including a connecting piece that can be attached to the heart chamber wall. The connecting piece defines a first opening through which a portion of a sleeve body can be inserted, which defines the second opening through which, for example, the heart pump can be passed. A non-return valve is arranged within the sleeve body, allowing insertion and removal of, for example, a heart pump or a punching tool with minimal blood loss.

[0010] German patent application DE 10 2006 021 974 A1 discloses a seal for a trocar sleeve in the form of an elastic sealing element that encloses a tubular cavity. This cavity axially surrounds the passage channel encompassed by the trocar, locally within the wall, and radially, and is capable of creating a fluid-tight seal with a medical instrument inserted into the trocar. Air can escape from and flow into the cavity through an opening within the sealing element, initiated by the medical instrument being inserted into or removed from the trocar.

[0011] Description of the invention

[0012] The invention is based on the objective of further developing a medical access sheath arrangement for creating access to a vessel or hollow organ through its vessel or organ wall, comprising a holding arrangement that can be fixed to the vessel or organ wall and a tube that has a connecting flange on its distal side for detachably secure and fluid-tight attachment to the holding arrangement, in such a way that the surgical procedure of creating an opening, particularly in the heart wall in the region of the apex of a patient's heart, as well as subsequent therapeutic measures, e.g., the application or replacement of a ventricular assist device or the implantation of a heart valve, are reliably and robustly enabled on the beating heart, i.e., without the use of a heart-lung machine. Both uncontrolled blood leakage through the opening from the heart and uncontrolled inflow of media from the outside into the heart, e.g.,It is essential to prevent air from entering the heart chamber. The medical airlock system should be easy to use, especially given the very limited space available intracorporeally (particularly with minimally invasive surgical access), and should allow surgical instruments, some with sharp cutting edges and / or varying dimensions, to be safely and safely guided through the airlock.

[0013] The solution to the problem underlying the invention is specified in claim 1. Claim 11 relates to a medical set for creating an opening in a vessel or hollow organ. Advantageously developing features of the invention are described in the dependent claims and the further description.

[0014] The solution-oriented medical access control device for creating access to a vessel or hollow organ through its vessel or organ wall, comprising a holding arrangement that can be fixed to the vessel or organ wall and a tube that has a connecting flange distally for detachably secure and fluid-tight attachment to the holding arrangement, is characterized by the fact that the tube has a tube wall through which at least one access channel projects laterally to the longitudinal extent of the tube, through which at least one inflatable body can be inserted into the tube and filled and emptied with a medium, or an inflatable body arranged in the tube wall can be filled and emptied with a medium, and that the inflatable body is designed such that, in the filled state, it fully conforms to an inner tube wall associated with the tube and is able to seal the tube fluid-tight along its longitudinal extent.

[0015] In contrast to known airlock arrangements, the proposed airlock arrangement provides a fillable and also emptied inflatable body which, when emptied, can either be completely removed from the tube of the medical airlock arrangement or at least be completely arranged in the tube wall, so that the entire tube lumen is available for the insertion of a medical instrument in general, and of a punching or cutting tool for punching or cutting an opening in the vessel or organ wall, or of an inflow cannula or a heart pump through the previously introduced opening, as mentioned above, without collisions occurring with any components protruding into the tube lumen and occupying space.By completely removing the inflating body from the tube lumen, any damage to it is also prevented, especially when using sharp-edged medical cutting or punching tools.

[0016] In contrast, the inflatable body, introduced and filled into the interior of the tube through the access channel, establishes full, at least linear, contact with the inner tube wall. This ensures that the filled inflatable body creates a complete, fluid-tight seal along the tube's length. Unlike a check valve, which automatically forms a fluid-tight seal against the inner tube wall, the sealing function of the proposed airlock system is controlled by the user. This means the user or an assistant activates the inflation of the inflatable body, which then reliably seals itself against the inner tube wall. This significantly improves the operational reliability of the airlock system compared to return-force-driven check valves.Moreover, the solution-oriented lock arrangement ensures a secure fluid-tight seal, both against media pressure acting extracardially on the inflator and against media pressure acting intracardially on the inflator.

[0017] In a preferred embodiment, the inflatable element is designed in the form of a balloon, which can be inserted into and removed from the tube through the lateral access channel. The balloon is also fluid-tightly connected to a media source that is designed and arranged separately from the tube, and which the user or an assisting person can activate for the purpose of inflating the inflatable element and preferably also for its controlled deflation.

[0018] The inflatable body, inserted and filled within the tube, forms a fluid-tight and axially rigid connection with the inner tube wall due to its inflation pressure, based on a frictional force-fit connection. In a further embodiment, the frictional connection between the inner tube wall and the filled inflatable body is supplemented by a positive fit. For this purpose, a groove-shaped recess is provided in the tube wall in an area opposite the access channel. When filled, a lateral extension of the inflatable body projects into this recess, forming a positive fit. This additional positive fit ensures a defined axial position of the inflatable body along the length of the tube.

[0019] Preferably, the inflating element is made of an elastomeric material and is designed such that, when filled, it assumes a discoid, cylindrical, or spherical balloon shape without any further external force or external mechanical constraint exerted on it by the inner wall of the tube. For filling and emptying, the inflating element includes a lateral hollow section integrally connected to it and constitutes a separate unit from the tube.

[0020] In another embodiment, the inflator is permanently connected to the tube. For this purpose, the tube has a groove-shaped recess on its inner wall, extending along a cross-sectional plane oriented orthogonally to the tube's longitudinal axis, in which the deflated inflator is completely housed. Preferably, the groove-shaped recess extends along half of the circumferential edge of the inner tube wall. The deflated inflator, located within the groove-shaped recess, does not protrude beyond the inner tube wall, or only does so minimally, thus ensuring that the inflator has no or only minimal contact with medical components passing through the tube. This is particularly important when cutting blades are inserted through the tube in close proximity to the inner tube wall, as these could otherwise damage the inflator.In this embodiment, when filled, the inflatable body preferably assumes a discoid or cylindrical shape, the outer circumferential edge of which fits fluid-tight against the inner tube wall. In the same manner as in the embodiment described above, the inflatable body is connected to a hollow tube for filling and emptying, which extends outwards through the lateral access channel and the tube wall.

[0021] In another embodiment of the airlock arrangement, the tube has a groove-shaped recess that completely encircles its inner wall along a cross-sectional plane oriented orthogonally to the tube's longitudinal extent. The inflatable element, which in this case is ring-shaped, is completely housed in this recess when deflated. That is, the inflatable element is inserted into the recess without any or only a minimal projection radially inward beyond the inner tube wall.

[0022] When inflated, the inflatable body assumes a ring-free shape, completely sealing the tube along its length and creating a fluid-tight seal. A ring-free shape means that, when inflated, the inflatable body has no opening along its length through which a fluid, i.e., a liquid or gas, could pass.

[0023] As an alternative to the ring-shaped inflator described above, at least two separate inflators are inserted along the groove-shaped recess that runs completely around the inner tube wall. When filled, these inflators overlap in a fluid-tight manner. The at least two inflators are connected, either separately or together, via a hollow tube for filling and emptying.

[0024] The advantage of a ring-shaped inflator or at least two separate inflators overlapping in a fluid-tight manner compared to a single, preferably spherical inflator lies in the fact that a medical component guided in the tube, e.g. in the form of a guide wire, a catheter or a cannula, can protrude through the at least partially filled inflator along the tube, which at the same time fits fluid-tightly against the outer contour of the medical component.

[0025] In a further preferred embodiment, the tube provides at least one axial predetermined breaking point oriented in the longitudinal direction of the tube or a detachably fixed joining connection for local axial separation of the tube wall, whereby the tube can be separated and removed from an inflow cannula or a heart pump in a radial direction relative to the longitudinal direction of the tube, for example, after insertion or passage of an inflow cannula or a heart pump.

[0026] Alternatively, or in combination with the aforementioned axially oriented predetermined breaking point, in a further embodiment the tube has at least one predetermined breaking point extending orthogonally to the longitudinal extent of the tube or a detachably fixed joining connection extending orthogonally to the longitudinal extent of the tube in order to separate the tube into at least two axially separable tube sections. In this way, the overall length of the tube can be shortened according to the therapeutic requirements after implantation in the heart wall by removing axial tube sections.

[0027] Along the tube, preferably along the proximal tube section opposite the connecting flange, at least one fastening structure is attached, preferably to the outer wall of the tube, to secure at least one further medical component, e.g., a heart pump. The connecting structure is designed as required, preferably in the form of a collar projecting radially outwards beyond the tube wall.

[0028] The solution-oriented sheath arrangement creates the conditions for surgical procedures to be performed on the beating heart, such as the implantation of a heart pump or a heart valve in a blood-filled heart without the use of a heart-lung machine (HLM) and thus avoiding all the disadvantages associated with HLM for the patient. After attaching the solution-oriented sheath arrangement to the outer wall of the heart in the region of the apex, an opening of a defined size must be cut or punched through the heart wall with as little tissue damage as possible. A specially designed cutting or punching tool with a tubular instrument housing is used for this purpose. The outer diameter of this tool and the inner diameter corresponding to the tube of the sheath arrangement are selected such that the cutting or punching tool can be guided bidirectionally through the tube and also forms a fluid-tight seal with the tube.The sluice arrangement and the cutting or punching tool form a solution-oriented medical set.

[0029] The cutting or punching tool is advanced through the tube without an inflator or with an empty inflator until it reaches the vessel or organ wall, e.g., the heart wall, whereby the cutting or punching tool forms a fluid-tight connection with the tube, which is maintained throughout the entire punching process by means of the cutting or punching tool, in which the cutting or punching tool is mounted in a sliding manner relative to the tube but always protrudes through the tube.

[0030] After creating the opening, for example within the heart wall, the cutting or punching tool is partially withdrawn proximally, but remains partially inside the tube while maintaining a fluid-tight seal. The inflator is then inserted into the tube and filled, or only filled, to create a local fluid-tight seal with the tube wall. The cutting or punching tool can then be completely removed from the tube.

[0031] The tube is then optionally shortened as needed, as explained above, so that the inflow cannula or the heart pump can subsequently be inserted into the heart chamber through the tube, to which the heart pump is connected in a fluid-tight manner. The inflator is removed from the tube as soon as the inflow cannula or the ventricular assist device connected to the heart pump is fluid-tightly attached to the tube. For this purpose, the cutting or punching tool has a penetration element attached distally to a shaft assembly that has a longitudinal axis. The penetration element is designed such that, when penetrating a tissue wall, it only displaces the tissue elastically radially to the penetration element without traumatically damaging it through tearing.

[0032] In a first version, the cutting or punching tool is characterized as follows:

[0033] The penetration body consists of at least one first and one second penetration body segment, which are axially mounted one behind the other along the shaft assembly and are independently and bidirectionally deflectable from each other. Furthermore, each penetration body segment has a first body section that tapers distally in cross-section and a second body section that immediately adjoins it proximally. The two body sections are monolithically connected.

[0034] The first body section of the first penetration body segment terminates distally, forming a tip, and the second body section, which adjoins the first body section proximally, at least partially limits a first cavity radially and has a cutting blade proximally surrounding the first cavity radially.

[0035] The first body section of the second penetration body segment has a distally tapered cross-section and features a recess on its distal side, axially oriented towards the first penetration body segment, into which the second body section of the first penetration body segment can be at least partially inserted. The second body section, which adjoins the first body section of the second penetration body segment proximally, radially delimits at least a portion of a second cavity and has a cutting blade on its proximal side that radially surrounds the second cavity.

[0036] In a second version, the cutting or punching tool is characterized as follows:

[0037] The penetration body consists of at least one first and one second penetration body segment, which are mounted separately along the shaft arrangement so as to be deflected bidirectionally.

[0038] The first penetration body segment is designed in the form of a cutting or punching sleeve, which has a cutting blade circumferentially on the distal side and radially limits a first cavity open on the distal side.

[0039] The second penetration body segment has a first body section that tapers distally in cross-section and has a recess oriented axially towards the first penetration body segment on its distal side, into which the first penetration body segment can be at least partially inserted. Furthermore, the second penetration body segment has a second body section that adjoins the first body section proximally and at least partially defines a second cavity radially, and has a cutting blade that radially surrounds the second cavity on its proximal side.

[0040] Brief description of the invention

[0041] The invention is described below by way of example, without limiting the general concept of the invention, with reference to the drawings. The drawings show:

[0042] Fig. 1a - d Multi-view drawings of a tube with connecting flange, Fig. 2a - d Multi-view drawing of a tube with an inserted inflator, Fig. 3a - c Multi-view drawing of a tube with cylindrical inflators arranged in the tube wall,

[0043] Fig. 4a, b Multi-view of a tube with a ring-shaped inflatable body attached to the tube wall,

[0044] Fig. 5a, b Multi-view of a lock chamber designed according to the solution with an internally guided cutting or punching tool,

[0045] Fig. 6 Longitudinal section through the distal region of a cutting or punching tool of a first type as well as

[0046] Fig. 7 Longitudinal section through the distal region of a cutting or punching tool of a second type.

[0047] Ways to implement the invention, industrial applicability

[0048] Figures 1a-d show the tube 1 of a medical airlock assembly 100 from different perspectives. Figures 1a and 1b are side views, Figure 1c is a longitudinal section, and Figure 1d is a bottom view. The following text refers to Figures 1a-d in their entirety.

[0049] The tube 1 has a straight-cylinder shape and possesses a longitudinal extension A, a distally formed connecting flange 2, and a freely accessible tube opening 3 axially opposite the connecting flange 2. The tube 1, with its essentially hollow cylindrical wall 4, encloses an inner straight-cylindrical tube lumen 5.

[0050] A transverse access channel 6 extends through the tube wall 4, perpendicular to the longitudinal extent A of the tube. This access channel is large enough to introduce an inflator 12, as will be explained below, through the access channel 6 into the tube lumen 5 and position it there. The access channel 6 is preferably located directly adjacent to the distally formed connecting flange 2.

[0051] Preferably, a diaphragm valve 7 is attached, for example, directly or indirectly along the access channel 6, which is able to form a fluid-tight seal with a hollow tube 13 that is able to connect with the inflating body 12 which will be described below.

[0052] At least opposite the access channel 6, a groove-shaped recess 8 is provided in the tube wall 4, which serves for an exact fit and for a positive locking connection with an inflating body 12 to be inserted into the tube wall 4.

[0053] The connecting flange 2, attached distally along the tube 1, serves for a mechanically detachable fixed connection to a holding arrangement 19 that can be fixed directly to an organ wall 17, which is shown in detail in further detail in conjunction with Figure 2d.

[0054] Within the tube wall 4, at least one predetermined breaking point 9 is provided axially to the tube's longitudinal extent A, preferably in the form of a local linear reduction in the tube wall thickness, which makes it possible to manually break open the tube 1 along its longitudinal extent A and, if necessary, to remove it completely. For this purpose, the connecting flange 2 is also designed in two parts, as can be seen in the axial view in Figure 2d. The two axially extending predetermined breaking points 9 provided on the tube 1 are arranged in axial overlap with the breaks 31 provided on the connecting flange 2.

[0055] The connecting flange 2 can preferably be connected to the holding arrangement 19, fixed to the outer wall of the organ (see Fig. 2d), via the openings 32 provided on the connecting flange 2, using screw connections. In addition, a second predetermined breaking point 10, running orthogonally to the longitudinal extension A of the tube, is provided, which makes it possible to axially detach a proximal tube section 11 from the rest of the tube 1. Instead of a local reduction in the tube wall thickness, the second predetermined breaking point 10 can be realized by a detachably fixed clamp connection, which is band-shaped and circumferentially wrapped around the axially contacting ends of both the tube 1 and the proximal tube section 11, thus connecting both parts fluid-tight (not shown).

[0056] The radially projecting extensions 33 attached to the outer wall of the tube 1 assist in handling the tube 1, in particular for breaking open the predetermined breaking point 9 and removing the tube 1.

[0057] Figures 2a-c show the tube 1 described above with an inflator 12 inserted into the tube lumen 5, which is introduced into the interior of the tube 1 via the access channel 6. Figure 2d shows the sheath assembly 100 consisting of the tube 1 with the inflator 12 arranged inside, which is positioned extraventricularly around an opening 18 in the heart wall 17.

[0058] The inflatable body 12 can be filled or emptied via a hollow tube 13, which is monolithically connected to the inflatable body 12 and leads to the outside through the access channel 6. For this purpose, the hollow tube 13 is connected to a media source 14.

[0059] In its inflated state, as can be seen particularly in the longitudinal section view according to Figure 2b, the inflator 12 forms a fluid-tight seal against the inner tube wall 15. Furthermore, the inflator 12 has a projection 16 that is arranged opposite the access channel 6 and the hollow tube and engages in a form-fitting manner in a groove-shaped recess 8 within the tube wall 4 opposite the access channel. The diaphragm valve 7 or similar device arranged at the end of the access channel 6 forms a fluid-tight seal around the hollow tube 13 and prevents both the escape from and the entry of liquid or gas through the access channel 6. The inflator 12, which is connected to the media source 14 via the hollow tube 13, is balloon-shaped and made of an elastically deformable elastomer, which, in its inflated state, preferably assumes the shape of a discoid, cylindrical, or spherical balloon.The inflating body 12, shown with a solid line in Figure 2b, has a cylindrical shape and conforms fluid-tight to the inner wall of the tube 1 over a large area. Alternatively, the inflating contour of a differently designed inflating body 121 is illustrated with a dashed line. This inflating body has a flattened convex shape inside the tube 1. This shape can be attributed to the fact that the upper and lower convex walls of the inflating body, shown in the illustration, are connected inside the inflating body by a connecting web 122, which limits the expansion of the inflating body in the longitudinal direction of the tube. In this way, a more compact inflating body shape can be achieved in the axial direction along the tube 1, which also allows the tube length to be reduced. The hollow tube 13 is monolithically connected to the inflating body 12 and, due to its selected wall thickness, exhibits considerable dimensional stability.The extension 16, which is also monolithically connected to the inflating body 12, remains dimensionally stable regardless of the filling state of the inflating body 12.

[0060] Figure 2d shows the schematic arrangement of the solution-designed sheath assembly 100 at an opening 18 provided in the heart wall 17. The tube 1, shown in longitudinal section, is mechanically detachably connected via its distally arranged connecting flange 2 to a ring-shaped retaining arrangement 19, which in turn is firmly attached to the outside of the heart wall 17, encompassing the opening 18.

[0061] The inflatable body 12, arranged within the tube lumen 5 in the filled state, ensures a fluid-tight seal at the opening 18 of the heart wall 17.

[0062] The tube 1 illustrated in Figure 2d is shortened after breaking the radial predetermined breaking point 10 and separating the axially upper tube section 11. In this spatially reduced design, the tube 1, which is firmly attached to the heart wall 17, offers the possibility of a fluid-tight connection with a cardiac support system 20, which provides an inflow cannula 21 that can be inserted fluid-tightly into the tube 1 via the tube opening 3 and firmly connected to the tube 1.

[0063] Figures 3a-c illustrate an alternative embodiment of a medical airlock assembly 100. Figures 3a-c depict sequence images showing the airlock assembly 100 from a top-down oblique angle and illustrating the deployment process of a disc-shaped inflatable body 12'. The tube 1 has a semicircular, groove-shaped recess 22 extending along a cross-sectional plane oriented orthogonally to the tube's longitudinal extent A. The inflatable body 12' is completely inserted into this recess when deflated, i.e., without projecting radially inward beyond the inner tube wall 4. The inflatable body 12' is connected, as in the embodiments described above, to a hollow tube (not shown) that projects through the lateral access channel 6 and is connected to a media source.Figure 3b shows a sequence in which the inflating body 12' is partially filled and begins to expand in a disc-like shape along the cross-sectional plane until, finally, when the inflating body 12' is completely filled, it lies fluid-tight against the inner tube wall 4 in its fully developed disc shape, see Figure 3c.

[0064] As an alternative to the disc-shaped design of the inflating body 12' in the dilated state, an annular inflating body is conceivable which, in the dilated state, with its outer ring surface, lies fluid-tight against the inner tube wall 4 and whose inner surface enclosed by the annular inflating body is spanned by a fluid-tight membrane, which is preferably integrally connected with the inflating body and is thus able to seal the tube 1 from the inside.

[0065] Advantageously, the tube wall 4 provides a further circumferential recess 22' in the cross-sectional plane, into which the expanding edge of the unfolding disc- or disk-shaped inflatable body 12' opens for axial support. After appropriate deflation of the inflatable body 12', which is preferably assisted by suction, the inflatable body 12' is able to return to its initial shape shown in Figure 3a, in which the inflatable body 12' is completely arranged within the semicircular, groove-shaped recess 22. Optionally, the inflatable body 12' can also be completely removed from the tube 1 through the lateral access channel 6.

[0066] It is also conceivable to arrange at least two separate inflating bodies within a completely circumferential groove-shaped recess within the inner tube wall 4, each opposite each other in a common cross-sectional plane or in two axially adjacent cross-sectional planes, which, when filled, join together at the end face in the middle or at least overlap in some areas and thus ensure a fluid-tight seal of the tube 1.

[0067] Another alternative embodiment is illustrated in Figures 4a and 4b, where Figure 4a shows an axial top view and Figure 4b a longitudinal section through the airlock assembly. A groove-shaped recess 23, extending radially around the entire length A of the tube, is provided within the tube wall 4. An annular inflatable body 12" is inserted into this recess. It is assumed that, in its deflated state, the annular inflatable body 12" is completely retracted within the groove-shaped recess 23 without projecting radially inward beyond the tube wall 4. Via a hollow tube 13, connected to a media source (not shown) and passing through the lateral access channel 6, the inflatable body 12" is inflated to the filled state, in which it completely seals the tube 1 fluid-tight without any annular opening.

[0068] Figure 4a shows a partially filled inflatable body 12", which has an inner opening contour 24 and thus offers the possibility of guiding a medical component through the tube 1 and the inflatable body 12" in a fluid-tight manner, by the inner opening contour 24 conforming fluid-tightly to the medical component (not shown). The inner opening contour 24 of the inflatable body 12" is typically adapted to the outer contour of the medical component to be guided through the airlock assembly 100. In the case of Figure 4a, the opening contour 24 is cloverleaf-shaped. Of course, other opening contours are also conceivable, e.g., annular hole contours, which are circular or have geometries deviating from a circular shape.

[0069] Figure 5a shows a side view of a medical set consisting of the solution-constituted sheath arrangement 100 and a cutting or punching tool (coring tool) 25, which extends through the tube 1 of the sheath arrangement 100.

[0070] Figure 5b shows a corresponding longitudinal section through the set of lock assembly 100 and cutting or punching tool 25 shown in Figure 5a.

[0071] In the state shown in Figures 5a and b, the inflating body is completely removed from the lock assembly 100. The cutting or punching tool 25 has a tubular instrument housing 26 with an outer diameter that is adapted to the inner diameter of the tube 1 of the lock assembly 100, so that the cutting or stationary tool 25 can be guided bidirectionally through the tube 1 and also forms a fluid-tight seal with it.

[0072] The punching tool 25 makes it possible to create an opening in the heart wall. For this purpose, the cutting or punching tool 25 has a distally tapered penetration body 27 at its distal end, which is composed of three penetration body segments 291, 292, 293 arranged separately along the longitudinal axis A of the tube distally on a shaft assembly 28. Each individual penetration body 291, 292, 293 can be deflected individually by means of manual actuating means 30 attached proximally to the shaft assembly 28.

[0073] The special feature of the cutting or punching tool 25 illustrated in Figures 5a and 5b is that the heart wall is first penetrated by the first, i.e., the distally arranged penetration body segment 291, by means of elastic displacement until the entire first penetration body segment 291 has completely penetrated the heart wall and is located in the heart chamber. By retracting the first penetration body segment 291 proximally, a first opening is cut into the heart wall by means of a cutting blade 2910 arranged proximally on the first penetration body segment 291.

[0074] The penetration process is repeated by jointly advancing the first and second penetration body segments 291, 292 distally through the existing first opening. Due to the larger outer diameter of the second penetration body segment 292, the heart wall is able to expand elastically again radially during penetration. Upon proximal withdrawal of both penetration body segments 291, 292, the opening is enlarged by the marginal incision action of the cutting blade 2920, which is attached proximally to the second penetration body segment 292. Similarly, the opening within the heart wall is further enlarged by the third penetration body segment 293 and the cutting blade 2930 attached to its proximal side.

[0075] To prevent blood from the heart chamber from passing through the sheath assembly 100 after the punching tool 25 has been removed from the sheath assembly 100, or to prevent an uncontrolled inflow of media from outside into the heart, e.g., air entering the heart chamber, the inflatable body is inserted into the tube 1 through the access channel 6 and filled after a proximal partial retraction of the cutting or punching tool 25. Once the inflatable body is completely filled, the cutting or punching tool 25 can be completely separated from the sheath assembly 100.

[0076] If a heart pump 20, as shown in Figure 2d, is to be inserted into the airlock assembly 100, the inflatable body 12 remains inflated until the inflow cannula 21 is connected to the tube 1 in a fluid-tight manner. The inflatable body 12 can then be deflated and removed. The heart pump 20, connected to the tube 1, takes over the sealing function at this point.

[0077] The novel lock arrangement 100 thus creates the prerequisite for a fluid-tight use of a cutting or punching tool to create an opening in the heart wall and a subsequent application of a cardiac support system, avoiding the use of a heart-lung machine and the associated disadvantages.

[0078] Figure 6 shows a detailed longitudinal section view of a penetration body 27 of a cutting or punching tool 25, which is composed of two separate penetration body segments 291, 292, with a proximal area of ​​the instrument housing 26 immediately adjoining it. The first penetration body segment 291 is arranged at the distal end of a central single shaft 34 of the shaft assembly 28, and the second penetration body segment 292 is attached to the distal end of a second single shaft 35. Both penetration body segments 291, 292 are shown in an axially interlocked state, the so-called initial or basic state, and thus form a single penetration body 27.

[0079] The first penetration body segment 291, attached to the distal end of the central single shaft 34, consists of a first body section 2911 tapering distally to a distal tip 36 and a second body section 2912 monolithically adjoining this body section proximally, the latter radially limiting a first cavity 291 H and closing proximally with a cutting blade 2910 that completely encloses the first cavity 291 H radially.

[0080] The first penetration body segment 291 is bidirectionally mounted along the shaft's longitudinal axis A separately from the second penetration body segment 292 and relative to the instrument housing 26 by means of the central single shaft 34, allowing it to be deflected. The second penetration body segment 292, like the first penetration body segment 291, has a first distally tapering body section 2921 and a second body section 2922 that monolithically adjoins it proximally. This second body section 2922 defines a second cavity 292H and has a cutting blade 2920 that radially surrounds the second cavity 292H on its proximal side.

[0081] Furthermore, the second penetration body segment 292 has a distally axially oriented recess 37, which is adapted in shape and size to the outer contour of the second body section 2912 of the first penetration body segment 291, so that the latter can be fully inserted into the recess 37, as can be seen in Figure 6. The second penetration body segment 292 is attached distally to the tubular single shaft 35, via which it is bidirectionally deflectable along the shaft's longitudinal axis A and rotatable about the shaft's longitudinal axis A.

[0082] In the embodiment shown in Figure 6, the first and second penetration body segments 291, 292 and the instrument housing 26 are rotationally symmetric about the shaft longitudinal axis A, i.e. the outer contours of the first body sections 2911, 2921, of the first and second penetration body segments 291, 292 together form a conical or cone-shaped geometry, to which the cylindrical outer contour of the second body section 2922 of the second penetration body segment 292 seamlessly connects. In the illustrated configuration of both penetration body segments 291, 292, the proximal end of the second body section 2922 of the second penetration body segment 292 also opens into an axially concentric recess 38 distally within the instrument housing 26, with the cutting blade 2920 of the second penetration body segment 292 touching the instrument housing 26 at its frontal end.Figure 7 shows a longitudinal section through the second variant of the cutting or punching tool 25.

[0083] The second variant also features a segmented penetration body 27 arranged along a shaft assembly 28. Unlike the first variant, the first penetration body segment 291' is designed as a cutting sleeve, radially defining a distally open first cavity 291H' and possessing a circumferential cutting blade 2910' distally. The first penetration body segment 291' terminates proximally with a sleeve base 39, which is rigidly connected to the central single shaft 34'.

[0084] In a preferred embodiment, a fixing element 40 is arranged within the cavity 291 H', which is designed to penetrate the vessel or organ wall and anchor itself therein. The fixing element 40, illustrated in Figure 7, is designed as a helical structure which, through rotation of the first penetration body segment 291 ' about the longitudinal axis A of the shaft, spirals into the tissue material in a helical manner to form a shear and tensile-resistant connection. The fixing element 40 is preferably attached to the proximal side of the sleeve base 39.

[0085] The second penetration body segment 292' is designed similarly to the second penetration body segment 291 of the first variant of the cutting or punching tool 25 illustrated in Figure 6. The second penetration body segment 292' has a first body section 2921' that tapers distally in cross-section and a second body section 2922' immediately adjoining it proximally. The second penetration body segment 292' has a distally open recess 37' into which the first penetration body segment 291' can be inserted, at least partially, preferably completely. In addition, the second body section 2922' radially defines a second cavity 292H', which terminates proximally with a radially circumferential cutting blade 2920'.In the axially nested position of both penetration body segments 291', 292' shown in Figure 7, the cutting blade 2920' abuts the end face of the instrument housing 1' in a distally oriented recess 38'. The second penetration body segment 292' is fixedly attached to the distal end of a tubular single shaft 35' for bidirectional deflection along the shaft's longitudinal axis A. Preferably, the first and second penetration body segments 291', 292' are rotationally symmetrical. In this case, the first body section 2921' of the second penetration body segment 292' is frustoconical, and its second body section 2922' is hollow cylindrical. However, it is also possible to design the penetration body segments 291 ', 292' together with the instrument housing 1 ' axially symmetric to the shaft longitudinal axis A, e.g. with an elliptical or oval or similar cross-sectional shape.

[0086] Reference symbol list

[0087] AT ubus longitudinal extension

[0088] 1 tube

[0089] 100 medical lock arrangement

[0090] 2 connecting flange

[0091] 3 Tube opening

[0092] 4 Tube wall

[0093] 5 tube lumens

[0094] 6 Access channel

[0095] 7 Diaphragm valve

[0096] 8 groove-shaped recesses

[0097] 9 axial predetermined breaking point

[0098] 10 radially circumferential predetermined breaking points

[0099] 11 axial tube part

[0100] 12, 12', 12" inflator

[0101] 121 Bloating

[0102] 122 Connecting bridge

[0103] 13 Hollow conduit

[0104] 14 Media source

[0105] 15 inner tube wall

[0106] 16th continuation

[0107] 17 Heart wall

[0108] 18 Opening

[0109] 19 Holding arrangement

[0110] 20 Heart pump, cardiac support system

[0111] 21 Inflow cannula

[0112] 22, 22', 23 groove-shaped recess

[0113] 24 inner opening contour

[0114] 25 Cutting or punching tool

[0115] 26 tubular instrument housing 27 penetration body

[0116] 28 Shaft arrangement

[0117] 291 , 291 ' first penetration body segment

[0118] 2911 first body section of the first penetrating body segment

[0119] 2912 second body section of the first penetrating body segment

[0120] 291 H first cavity

[0121] 2910 cutting blade

[0122] 292, 292' second penetration body segment

[0123] 2921 , 2921 ' first body section of the second penetrating body segment

[0124] 2922, 2922' second body section of the second penetration body segment

[0125] 292H, 292H' second cavity

[0126] 2920, 2920' cutting blade

[0127] 293 third penetration body segment

[0128] 2930 cutting blade

[0129] 30 manual actuators

[0130] 31. Break at the connecting flange

[0131] 32 Opening

[0132] 33 radially projecting extension on the tube

[0133] 34, 34' Single shaft

[0134] 35, 35' further individual

[0135] 36 peak

[0136] 0.37' recess

[0137] 38, 38' recess

[0138] 39 shell base

[0139] 40 fixing element

Claims

Patent claims 1. Medical access device (100) for creating access to a vessel or hollow organ through its vessel or organ wall (17) comprising a holding device (19) that can be fixed to the vessel or organ wall (17) and a tube (1) which has a connecting flange (2) distally for detachably and fluid-tightly joining to the holding device (19), characterized in that the tube (1) has a tube wall (4) through which at least one access channel (6) projects laterally to the longitudinal extension (A) of the tube, through which at least one inflator (12) can be inserted into the tube (1) and filled and emptied with a medium, or an inflator (12) arranged in the tube wall (4) can be filled and emptied with a medium, and that the inflator (12) is designed such thatthat the inflatable body (12), when filled, fully conforms to an inner tube wall (4) associated with the tube (1) and is able to seal the tube (1) fluid-tight along its longitudinal extension (A).

2. Medical slurry arrangement according to claim 1, characterized in that the inflating body (12) in the filled state conforms fluid-tight to the inner tube wall (4) along at least one cross-sectional plane attributable to the tube (1).

3. Medical airlock arrangement according to claim 1 or 2, characterized in that the inflatable body (12) is designed in the form of a balloon which can be inserted into and removed from the tube (1) via the access channel (6) and is fluid-tightly connected to a media source (14) and sink via a hollow tube (13).

4. Medical airlock arrangement according to one of claims 1 to 3, characterized in that a groove-shaped recess (8) is provided laterally opposite the access channel (6) in the tube wall (4) and that in the filled state of the inflatable body (12) a lateral extension (16) of the The inflating body (12) opens into the groove-shaped depression (8) forming a positive locking connection.

5. Medical airlock arrangement according to claim 1, characterized in that the tube (1) provides a groove-shaped recess (22) on its inner tube wall (4) along a cross-sectional plane, in which the inflatable body (12) is completely housed in the emptied state, and that the inflatable body (12) assumes a discoid or more cylindrical shape in the filled state, the outer circumferential edge of which fits fluid-tightly against the inner tube wall (4).

6. Medical airlock arrangement according to claim 1, characterized in that the tube (1) provides a fully circumferential groove-shaped recess (23) along the cross-sectional plane in which the at least one inflating body (12) is completely housed in the emptied state, and that the at least one inflating body (12) is ring-shaped and assumes a ring-opening-free inflating body shape in the filled state, or that at least two inflating bodies (12) are provided which are in fluid-tight contact with each other in the filled state.

7. Medical airlock arrangement according to one of claims 1 to 6, characterized in that the tube (1) has at least one axial predetermined breaking point (9) oriented in the longitudinal extension (A) of the tube or a detachably fixed joining connection for local axial separation of the tube wall (1 ).

8. Medical airlock arrangement according to claim 7, characterized in that the tube (1) has at least one predetermined breaking point (10) perpendicular to the longitudinal extension (A) of the tube or a detachably fixed joining connection for separation into at least two axially separable tube parts (11).

9. Medical airlock arrangement according to one of claims 1 to 8, characterized in that the tube (1) has a fastening structure axially opposite the connecting flange (2) designed for detachably fixed and fluid-tight joining to the holding arrangement (19).

10. Medical airlock arrangement according to claim 9, characterized in that the fastening structure is designed in the form of a collar projecting radially outwards beyond the tube wall (4).

11. Medical set comprising a lock assembly (100) according to one of claims 1 to 10 and a cutting or punching tool (25) with a tubular instrument housing (26) whose outer diameter and inner diameter attributable to the tube (1) are selected such that the stationary tool (25) can be guided bidirectionally through the tube (1) and seals fluid-tight with the tube (1).

12. Medical set according to claim 11, characterized in that the cutting or punching tool (25) has a penetration body (27) attached distally to a shaft arrangement (28) which has a shaft longitudinal axis, that the penetration body (27) is composed of at least one first and one second penetration body segment (291, 292) which are mounted axially one behind the other and separately from each other in a bidirectionally deflectable manner along the shaft arrangement (28) and each has a first body section (2911, 2921) tapering distally in cross-section and a second body section (2912, 2922),that the first body section (2911) of the first penetration body segment (291) terminates distally, forming a tip (36), and the second body section (2912) adjoining the first body section (2911) proximally at least partially radially limits a first cavity (291 H) and has a cutting blade (2910) radially enclosing the first cavity (291 H) proximally, and, that the first body section (2921) of the second penetration body segment (292) has a distally tapered cross-section and a distally oriented recess (37) facing axially towards the first penetration body segment (291), into which the second body section (2912) of the first penetration body segment (291) can be inserted at least partially, and the second body section (2922) adjoining the first body section (2921) of the second penetration body segment (292) at least partially limits a second cavity (292H) radially and has a cutting blade (292H) radially enclosing the second cavity (292H) on the proximal side.

13. Medical set according to claim 11, characterized in that the cutting or punching tool (25) provides a penetration body (27) attached distally to a shaft arrangement (28) having a shaft longitudinal axis, that the penetration body (27) is composed of at least one first and one second penetration body segment (291', 292') which are mounted separately and bidirectionally deflectable from one another along the shaft arrangement, that the first penetration body segment (291') is designed in the form of a cutting sleeve which radially delimits a distally open, first cavity (291H') and has a circumferential cutting blade (2910') distally, and that the second penetration body segment (292') has a first body section (2921') tapering distally in cross-section, which has a axially distally extending to the first penetration body segment (291'). has a recess oriented towards the front (37'),into which the first penetration body segment (291') can be inserted at least partially, and has a second body section (2922') which at least partially radially limits a second cavity (292H') and has a cutting blade (2920') radially enclosing the second cavity (292H') on the proximal side.

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