WO1993000129A1

WO1993000129A1 - Implantable port

Info

Publication number: WO1993000129A1
Application number: PCT/EP1992/001352
Authority: WO
Inventors: Zeljko MILOS^¿EVIC; Renate MILOS^¿EVIC
Original assignee: Milosevic Zeljko
Priority date: 1991-06-20
Filing date: 1992-06-15
Publication date: 1993-01-07

Abstract

In an implantable port (1) with a catheter (28) connected thereto, the connection between the inside (6) of the port (1) and the tip of the catheter (28) connected thereto is closed by a valve (32; 10, 17, 18) which, when the port (1) is punctured, is opened either solely by the pressure of the injection medium or by mechanical contact with a puncturing canula. To prevent thrombosis and blockages of the port system, the valve is arranged in the port system at such a point that the tip of the catheter (28) used for introduction into the vessel to be catheterised is open and contains no valve parts.

Description

IMPLANTABLE PORT

The invention relates to an implantable port with a closed hollow body, the wall delimiting its interior has a wall area formed by a puncturable, elastic membrane and a connection opening into the interior for a catheter, the tip of which faces away from the connection Introduction into a vessel to be catheterized, and with a valve which is closed in its unactuated state serves as a shut-off device on the way from the port interior to the catheter tip.

Such ports serve as. long-term body access

Systems for continuous therapy in which punctures, injections or infusions have to be carried out over a long period of time. For this purpose, the port is implanted subcutaneously and its one end is connected to the connection opening. This catheter with its tip opposite this end is guided inside the body to the point to which access is required. For example, the tip of the catheter can be placed in an artery, a vein or in the epidural or intrathecal space. The tip of the catheter can also be connected to an occluder, which is arranged on a blood vessel and throttles or closes this blood vessel when pressure medium is applied. The application areas of the ports thus extend in particular to chemotherapy for cancer treatment, the therapy of arterial occlusive diseases, the treatment of pain and the provision of vascular accesses which can be punctured quickly in emergency patients.

After subcutaneous implantation of the port, its interior can be punctured by means of a puncture cannula through the elastic membrane and the skin above it, so that on the one hand substances are injected into the vessel connected to the catheter tip and on the other hand also body fluids, in particular blood. can be removed from the connected vessel. However, there is a difficulty that in particular ^" during or after a puncture procedure, body fluid, in particular blood, can penetrate into the catheter and lead to blockage of the catheter. In addition to health risks that are caused by body fluids remaining in the catheter, This leads in particular to blockages of the catheter, and these difficulties cannot be ruled out by frequent flushing of the port system.

In known catheters of the type mentioned at the outset, these difficulties are to be avoided by the valve which normally closes the catheter and which is only opened during the puncture procedure by the pressure exerted via the puncture cannula. The valve is immediate arranged on the catheter tip used for insertion into the vessel to be catheterized.

In such an embodiment, the tip of the tube forming the catheter is closed and the tube is provided with lateral, axial slots which are closed due to the elasticity of the tube material and which only open when the agent to be injected is under pressure from the interior by means of the puncture cannula port is fed here. In another embodiment, the valve is inserted into the tip of the catheter tube, which is open at its end, and opens when pressure is exerted in the axial direction of the catheter tube. Should . If the valve on the catheter tip is also suitable for removing body fluid, then it has side flaps on the valve body that only open when there is negative pressure. These flaps cannot therefore be reached by rinsing liquid, since they only allow body fluid to wash around the outside of the catheter tip.

Since in all known embodiments the valve is arranged directly on the tip used for insertion into the vessel and therefore lies inside the vessel when the port is in use, body fluid, in particular venous or arterial blood, is constantly applied to it , so that it can accumulate. In addition, penetration of the body fluid into the valve cannot be reliably ruled out during puncturing. Because of its location on the tip of the catheter, the valve cannot be cleaned by irrigation fluid injected into the port. As a result, the known valves on the catheter tip are themselves susceptible to constipation. In particular, it has been shown that with such valves in arterial vessels, the blockage probability is 50% within six months. With valves inserted into venous vessels, the likelihood of clogging is high somewhat smaller, but by no means negligible. In addition, it is particularly unfavorable that a thrombus always forms on the catheter in the area of these valves, which creates the risk of microembolism. If such a valve finally has to be replaced due to a malfunction that cannot be remedied, a major surgical intervention is always required at the connection point of the catheter to the vessel, usually in the abdominal cavity.

The invention has for its object to provide an implantable port of the type mentioned, the functionality of which is ensured for a long time and in addition the risk of thrombosis is considerably reduced.

According to the invention, this object is achieved in that the valve is arranged at a distance from the tip which is used for insertion into the vessel to be catheterized.

In the case of the invention, the tip used for insertion into the vessel to be catheterized is therefore completely open and free of opening and closing obstacles in the tip of the catheter to be inserted into the vessel. Because of this fluid dynamically favorable conditions in the region lying in the vascular region of the catheter occur there no disturbances and / or deposits, ^"in particular of blood, whereby a Thrombusgefahr is excluded. Since by the arranged at a distance from the tip valve is a secure Closure of the catheter is guaranteed, but even after the puncture procedure * a completely stable liquid column of the injected agent remains between the freely ending tip of the catheter and the valve arranged at a distance therefrom, so that no blood can flow back into the catheter the formation of gas inclusions, especially air, in the area of the tip of the catheter safely excluded, since the stable liquid column extends completely to the open mouth of the tip of the catheter.

As a result of its functional reliability, the time interval between rinses can also be considerably increased. Another advantage of arranging the valve at a point in the system that is moved away from the tip used for insertion is that, in the event of a malfunction, it is not necessary to intervene surgically at the connection point between the catheter and the vessel, but rather the intervention in the position area of the valve itself which is expediently chosen in an easily accessible place ...

These advantages of the port according to the invention are therefore already achieved with embodiments in which the valve is arranged in the catheter. It only has to be ensured that the valve is set back so far from the tip that it is in any case outside the vessel to be catheterized.

However, it proves to be particularly advantageous if the valve is close to that .; Connection is arranged. Since the hollow body of the port is implanted subcutaneously at an easily accessible location on the body, the valve located near the connection provided on the wall area of the hollow body is then easily accessible and can be operated without major intervention, possibly together with the hollow body , be replaced. This is made even easier if the valve is arranged in a pluggable adapter.

A particularly advantageous embodiment consists in the valve being arranged in the connection. In this embodiment, the valve and the hollow body form a unit. In particular, the valve can be arranged inside the wall, which at this point of the connection for establishing the connection between the interior and the catheter to be connected externally is broken through in a channel-like manner.

Another particularly advantageous embodiment is that the valve is arranged in the interior. The valve can be accommodated in the interior of the hollow body without any appreciable enlargement of the port. The catheter then extends freely from the connection to its open tip without any flow obstacles being present in the catheter itself or in the region of its connection to the hollow body.

In the embodiments described above, the valve which is self-closing in its non-actuated state is opened by the pressure acting on the valve of the agent supplied during the puncture by means of the puncture cannula. These embodiments are therefore particularly suitable for applications in which the port is connected to an arterial vessel, as for example in the regional chemotherapy of the liver or intraarterial Prostaglandintherapie on ^'the common femoral artery of the case. In these therapeutic applications, only one agent is injected into the vessel at a time via the port system, while aspiration for the purpose of removing body fluid via the port system is not necessary. In contrast, in so-called venous port systems in which the catheter is connected to a venous vessel, both injection of therapeutic agents and blood withdrawal from the vessel by means of the port must be considered. It is therefore desirable here not only to open the valve when injecting, but also for the purpose of drawing in blood, for example. In this regard, it is therefore provided in the context of the invention that the valve has an actuating element arranged opposite to the membrane for transferring it into its open position. In this embodiment it is therefore possible to

Puncturing the elastic membrane to bring the puncture cannula into contact with the actuating element arranged opposite to the membrane and by means of this contact to move the actuating element into a position corresponding to the open position of the valve. The valve can thus be brought mechanically into its open position completely independently of the pressure conditions in the port system and the vessel connected to it, also by means of the puncture needle, so that, in particular, blood sampling is also possible. This possibility of mechanically opening the valve exists in addition to the purely pressure-dependent opening possibility, because in the case of injection, the pressure built up in the hollow body also acts independently of a mechanical contact on the actuating element and thereby brings about the opening of the valve.

A particularly expedient embodiment in this connection is that the actuating element has a platform facing the membrane. ^'The platform, which advantageously extends along the entire area occupied by the membrane surface, ensures that the cannula Punk¬ tion independent of .; their puncture site and their puncture angle securely and thus transfers the actuation movement of the puncture cannula to the actuation element of the valve under all circumstances. Because the platform retracts when its actuation movement counter to the closing force of the valve, the puncture needle is decelerated in their soft impact, so-that damage to the Kanü- be prevented lenspitze ^'. This is particularly advantageous for an injury-free withdrawal of the puncture cannula from the elastic membrane. The service life of the elastic membrane and thus of the port as a whole is thereby further increased. In all previous embodiments, there was only one valve which is closed in the direction of the port by pressurization and is opened mechanically by the puncture cannula or by the excess pressure of the injection means introduced through the puncture cannula. According to a further embodiment, a valve which can be opened by negative pressure is connected in parallel with this valve which can be opened by positive pressure. This is particularly expedient if both valves are arranged in the same spatial vicinity in the same flow line. The additional valve serves on the one hand for the removal of body fluid, since it opens in the opposite direction to the injection valve. On the other hand, this valve has a decisive advantage for cleaning the entire valve and for reducing the disadvantages mentioned above. Because. Now rinsing liquid can be injected and pressed into the common cavity of both valves through the injection valve, but can then be sucked back through the nozzle immediately. By repeating this operation, the entire Ven¬ tilkörper is purified by the repeated pressure and suction operation with washing liquid so after a blood collection via .den_ port, ^'so that the valves for a prak¬ table unlimited retention time in the implanted port, or as part of Can remain catheters. ^'''

Further features, details and advantages of the invention result from the following description and the drawing, to which express reference is made to all details not mentioned in relation to a disclosure essential to the invention. Show it:

1 shows a first embodiment of a port in perspective, partially cutaway view,

2 shows a section through the port of FIG. 1, 3 shows a sectional view of the port corresponding to FIG. 2 when puncturing,

4 shows a sectional view corresponding to the representation of FIG. 2 of a slightly modified second embodiment,

5 shows a sectional view corresponding to the representation of FIG. 2 of a slightly modified third embodiment,

Fig. 6 is a view of Fig. 2 corresponding sectional view of a somewhat more abgewandel¬ th fourth ^'embodiment,

7 is a sectional view corresponding to the representation of FIG. 2 of a fifth embodiment,

Fig. 8 is a sectional view corresponding to the representation of Fig. 2. heavily modified sixth embodiment,

FIG. 9 is a sectional view corresponding to the position of FIG. 2 of a seventh embodiment modified further from FIG. 8, and

10 shows an adapter with two valves opening in the opposite direction.

1 to 9, an implantable port 1 has an axially symmetrical hollow body 2, the axis of symmetry of which is denoted by A in FIGS. 2 to 8. The lower wall region 3 in FIGS. 1 to 9, which extends transversely to the axis of symmetry A, and the lateral wall region 4 of the wall region 4, which extends from there in the direction of the axis of symmetry A. Hollow bodies 2 are made of a plastic, for example, while the upper wall area 5 opposite the lower wall area 3 and extending transversely to the axis of symmetry A is formed by a membrane made of a puncturable, elastic material, for example silicone.

For a tight closure of the interior 6 enclosed by the hollow body 2 at the connection point between the lateral wall area 4 and the membrane 5, the latter is clamped at its edge in an annular groove 7 running around the inside of the lateral wall area 4. The axial dimension of the annular groove 7 is selected to be significantly smaller than the axial thickness of the membrane 5 in the τtne-clamped state, so that the membrane 5 thickens axially towards the central axis of symmetry A. For example, the axial thickness of the membrane 5 in the area of the annular groove 7 which clamps it in is 6 mm, while the thickness increases to 9 mm towards the center of the membrane. This not only ensures the tightness in the area of the annular groove, but also causes such an elastic prestress in the membrane 5 that punctures of a puncture needle after its removal from the membrane 5 are sealed not only because of the elastic material selection but also because of this prestress become.

In all of the embodiments shown in FIGS. 1 to 9, the lower wall area 3 has a flat surface on its outside and is provided with fastening holes 8 on its edge which is radially widened compared to the upper area having the membrane 5. The port 1 is implanted subcutaneously with its lower wall area 3 pointing towards the body and is fixed, for example, by non-absorbable surgical suture material with the aid of the fastening holes 8. In this position, the membrane 5 is removed from the body skin covered and can be pierced through it by means of a puncture cannula 9 shown in FIG. 3.

A valve provided in the hollow body 1 in the exemplary embodiments of FIGS. 1 to 6 has a piston 10, the two end faces 11 and 12 of which extend radially, that is to say transversely to the axis of symmetry A. Furthermore, in the exemplary embodiments from FIGS. 2 to 6, an annular groove 13, which is coaxial with the axis of symmetry A, is formed in the piston 10 from the lower end face 12, which has an annular web 14 which is complementary thereto and which is located on the inside of the lower wall area 3 is formed, is in sliding engagement, whereby the piston 10 is guided free of tilting or radial deviations along the direction of the axis of symmetry A.

The piston 10 is loaded in the axial direction towards the membrane 5 by an elastic element, which in the embodiments shown in FIGS. 1 to 6 is formed by a centrally and axially extending coil spring 15. This is in its upper region in a central bore 16 which is open on the lower end face 12 of the piston 10 and on the upper closed end face of which the upper end of the helical spring 15 is supported. The opposite lower end of the helical spring 15 is supported on the lower wall area 3.

Variations not shown in the drawing for the guidance of the piston 10 relative to the hollow body 2 and the support and guidance of the helical spring 15 consist, for example, of the helical spring 15 alternatively on a mandrel formed on the supporting end face 12 of the piston 10 or in an in to guide the lower wall area 3 formed recess. Furthermore, a mandrel formed on the lower end face 12 of the piston 10 could instead be in a on the lower wall region 3 trained cylindrical projection be slidably guided, the helical spring 15 then being able to be guided on the outer surface of the cylindrical projection.

In the embodiments shown in FIGS. 1 to 6, the piston 10 is designed in the form of a truncated cone converging towards the membrane 5. The extending between the upper and lower end faces 11 and 12 of the outer surface of the piston 10 forms a sealing surface 17, which has been conically formed in the interior 6 to form a counter-sealing surface 18 by the axial action of the piston 10 by means of the helical spring 15 ¬ lichen wall area 4 is sealingly held in system. As a result, the "area 19 of the interior 6 adjacent to the membrane 5 is opposite one another due to the sealing seat between the sealing surface 17 of the piston 10 and the counter-sealing surface 18 of the wall area 4 in the side wall area 4 provided opening of a connection 20, which opens into the interior 6 near the lower wall area 3, because the connection 20 in the sealing position of the piston 10 shown in FIGS. 2, 4 and 5 lies below the lower end face 12 of the piston 10.

2, 3 and 6, the surface line of the frustoconical sealing surface 17 and also the complementary sealing surface 18 is straight, in the modified embodiment of FIG. 4 the surface line of the sealing surface 17 is concave and that of the counter sealing surface 18 complementary convex curved. Conversely, FIG. 5 shows a modification in that the surface line of the sealing surface 17 is convex and that of the counter-sealing surface 18 is concavely curved.

In the embodiment of FIG. 6, the piston 10 stands with a cylindrical jacket region 21 extending from its lower end face 12, with a conical truncated jacket area 22, an adjoining radial shoulder surface 23 and an adjoining further cylindrical jacket area 24 of smaller diameter in contact with the inside of the lateral wall area 4 complementarily shaped to the shape of these jacket areas. The actual sealing surfaces are formed by the radial shoulder surface 23 and the complementary counter surface 25 of the side wall area 4, between which a radially annular elastic seal 26 is arranged. The opening of the connection 20 opens into the complementary frustoconical shell region 27 of the lateral wall region 4 into the interior and is thus closer to the membrane 5 than is the case with the embodiments shown in FIGS. 1 to 5 and 7 . However, here too the radial shoulder surface 23 acting as a sealing surface, the complementary counter surface 25 and the gasket 26 arranged between them are located between the opening of the connection 20 and the region 19 of the interior 6 adjacent to the membrane 5, so that the connection between the opening of the connection 20 and the membrane 5 in the normal position of the piston 10 shown in FIG. 6 is interrupted.

In deviation from the embodiments shown in FIGS. 1 to 6, the one comparable to that in the rest

7, instead of the movable piston 10, a flat radial plate 10 ', which is fixed immovably with respect to the side wall area 4, separates the area 19 of the interior 6 adjacent to the membrane 5 from the area of the interior 6 adjacent to the connection 20 in a sealing manner . The lower end face 12 'of the plate 10' lies axially with the lower wall area 3

Distance opposite, while the upper end face 11 'in one

Distance from the membrane 5 is arranged. In a central opening of the plate 10 ′ is a conical valve body 34 with a sealing surface 17 that tapers towards the membrane 5 forming the outer surface, while the counter-sealing surface 18 is formed by the outer surface of the opening in the plate 10 '. Comparable to the embodiments of FIGS. 1 to 6, a bore 16 is formed in the valve body 34 from its end face facing the lower wall region 3, in which a helical spring 15 which acts on the valve body 34 in the direction of the membrane 5 is supported. The other end of the coil spring 15 is supported on the lower wall area 3. The tapered end of the valve body 34 is adjoined by an axial connecting region 31, which at its end facing the membrane 5 has a related radial platform 30, which has a slight radial play with respect to the wall region 4 and, moreover, approximately occupies the entire radial surface of the membrane 5.

In the embodiments shown in FIGS. 1 to 6, the piston 10 thus forms, through the interaction of its sealing surface 17 with the counter-sealing surface 18 of the lateral wall region 4, a valve 19 separating the region 19 of the interior 6 adjacent to the membrane 5 from the connection opening 20. 7, the valve separating the area 19 from the connection opening 20 is formed by the valve body 34 which interacts with the plate 10 'and whose conical-shaped sealing surface 17 seals the complementary counter-sealing surface 18 of the plate 11 'cooperates. In contrast, in the embodiments of FIGS. 8 and 9, the valve 32 is in the connection 20 and in. the area of a catheter 28 connected to the connection 20 is arranged close to the port 1. In detail, in the embodiment of FIG. 8, the opening 33 of the connection 20 passing through the side wall region 4 is flared from the interior 6 to the exterior of the port 1, a conical valve body 34 having a complementary shape being mounted in this conical extension. The valve body 34 is by means of one of its Coil spring 35 determining the closing pressure is biased from its conically widened end face into the conically widened opening 33, so that the valve 32 is held in its closed position by the helical spring 35. Similarly, in FIG. 9 the flared opening 33 with the valve body 34 held by the helical spring 35 in the closed position is arranged in an intermediate piece 36 which is separate from port 1 and which is close to port 1 in the catheter 28 connected to port 20 is inserted.

In all embodiments, the connection 20 is used for connection to the catheter 28 schematically indicated in the drawing, the tip of which, facing away from the connection opening 20, is connected, for example, to a venous or arterial vessel or connected to an occluder (not shown ⁾ . Such occluders are arranged on a blood vessel and, when a pressure medium is supplied through the catheter 28, cause the blood flow to be throttled or closed. In this way, e.g. B. Temporary desarterializations of the hepatic aorta. performed for cancer therapy. When the tip of the catheter 28 is connected to a blood vessel, the port 1 serves to supply agents for chemotherapy and, in the case of venous vessels, alternatively also for taking blood. , ^'

The puncture process by which the pressure medium is applied to the occluder or for injection into or removal from. a vessel or connection necessary for other purposes between the catheter 28 and the puncture cannula 9 is shown for the embodiments shown in FIGS. 1 to 7 using the example of FIG. 3. After the cannula 9 pierces the membrane 5 ¬ chen, the cannula tip 29, irrespective of the puncture angle on the upper end face 11 of the piston 10 or the platform 30, comes into soft contact due to the resilient mounting of the piston 10 or the valve body 34. There is a soft displacement of the piston 10 against the force of the helical spring 15 in the direction of the axis of symmetry A. Since the axially thin platform 30 is inherently flexible, the embodiment equipped with the platform 30 enables the cannulas to hit particularly gently top 29.

As a result, the sealing surface 17 is lifted from the counter-sealing surface 18 or in FIG. 6 the radial shoulder 23, which for example carries the seal 26, from the counter-surface 25 and the connection between the connection opening 20 and that to the membrane 5 adjacent area 19 of the interior 6 released. Air or liquid can thus both be injected into the catheter 28 and removed from the catheter 28 through the puncture cannula 9. After the withdrawal of the injection cannula 9 from the membrane 5, the valve is closed again by the force of the coil spring 15. The membrane 5 is then completely decoupled from the pressure conditions prevailing in the catheter 28 and is therefore stress-free. The tightness of port 1 is therefore ensured even after a great number of punctures, which can ultimately lead to fatigue despite the pretensioning of membrane 5 mentioned at the outset. • - ^'

In the embodiments shown in FIGS. 1 to 6, the piston 10 thus acts simultaneously as a closure body and actuating member of the valve, while in the embodiment of FIG. 7 the actuating member through the platform 30 and the connection region 31 that actuates it with the valve body is formed. Instead, within the membrane 5 in the puncture area of the puncture cannula 9, only an actuating member which comes into contact with the cannula tip 29 could be arranged, the movement of which is transmitted as an opening movement to a valve arranged separately in the hollow body 2. The puncturing process described above is therefore based on a mechanical contact between the puncture cannula 9 and the piston 10 or the platform 30 serving as an actuating element. This handling means that the valve can always be opened regardless of the pressure conditions, especially in the If the catheter 28 is connected to a venous system, blood is drawn after the valve has been opened by suction. If such a removal is not intended, however, contact with the cannula tip 29 is not required. Rather, the pressure of the injection means supplied through the puncture cannula 9 is sufficient to move the piston 10 or the valve body 34 into its open position. The sixth and seventh embodiments shown in FIGS. 8 and 9 are based on such pressure actuation by the injector supplied. As can be seen from FIGS. 8 and 9, the injection agent supplied by the puncture cannula 9 acts in the interior 6 of the port 1, the pressure building up against the force of the spring 35 on the valve body 34 in the sense of a displacement of the valve body 3.4 into the 'open position. Thus, in the embodiments of FIGS. 8 and 9, the connection between the interior 6 and the tip of the catheter 28 is established solely by exerting pressure, while the embodiments of FIGS. 1 to 7 actuate the valve both by mechanical contact with the puncture cannula 9 and also alone enable by exerting pressure.

FIG. 10 shows an adapter 37 which can be inserted into the catheter 28, for example, in the manner of the valve 32 in FIG. 9 ^* . It is clear that, in some embodiments, the adapter 37 is also expediently arranged directly on the hollow body 2 of the implanted port 1. Finally, it is also clear that the special valve according to FIG. 10 explained in the following consists of two opening in the opposite direction and in the immediate spatial vicinity of valves arranged next to one another can also be arranged in the interior 6 of the hollow body 2 of the port.

An expansion 38 of the adapter 37 forms

Cavity, the volume of which is kept as small as possible by appropriate shaping. A sits in the center of the expansion 38. Central body 39, which forms the valve seats in the manner shown. The valve 32 can be recognized again. This opens automatically in the manner described above when an overpressure is generated on its left side in FIG. 10 by an injection means injected into the port 1. The injection agent can thus be passed on to the catheter tip in the manner already explained.

The valve 32 is again provided with a truncated cone-shaped valve body and has on its rear side a blind hole in which the helical spring 15 holding the valve is mounted at one end, the other end of which rests on a guide pin 40 which is axially parallel to one of the two ¬ the half body forming the adapter 37 protrudes into the line 38 on.

To improve the sealing effect, the truncated cone-shaped valve body has an additional rubber seal adapted to it in its jacket. This either results in the higher sealing effect or permits production with the same sealing effect _. lower precision requirements.

The decisive innovation here is that the valve

32, a nozzle 42 is arranged in parallel in the immediate vicinity in the same flow space and opens in the opposite direction. It is obvious that the opening pressures of valve 32 and nozzle valve 42 can be freely selected as required by appropriate selection of the springs acting on them or their corresponding preload can. As is clearly shown in FIG. 10, the nozzle valve 42 is constructed in the same way as the valve 32 through which the injection liquid is pressed. It is arranged in the central body 39 of the adapter 37 only in the opposite direction.

The dispensing valve 42 allows the removal of body fluid present to the right of the two valves in FIG. 10 with the aid. a negative pressure that is generated in the interior 6 of the port 1 with the aid of a puncture cannula 9. It can be clearly seen from the figure that the vacuum opening the nozzle valve 42 presses the valve 32 even more firmly into its valve seat and keeps it closed, while conversely the injection pressure opening the valve 32 presses the nozzle valve 42 into its valve seat and closes holds.

Of particular importance, however, is the possibility now opened for cleaning the valve arrangement after removal of body fluid. This is because a detergent (heparin-saline solution) can now be pressed in through the valve 32, but can also be sucked out again through the nozzle 42. If this happens several times, the entire interior of the adapter 37, including all surfaces of the valves 32 and 42, is of course completely cleaned, which was not possible with the previous valves on the catheter tip. It is obvious that the ^"adapter 37 with the Ventilanord¬ voltage regardless of the port structure can be used, thus also with other port structures as they are shown in FIGS. 1 to 9.

The exemplary embodiments described above make it clear that the shape of the valve is not important in detail. Any other valve, which can be arranged in the interior 6 of the port, in the connection 20, in the catheter 28 or in the adapter 37 and which has the closing and opening functions described above, could equally well be used. List of reference symbols

11.11 '

10

15

20th

25

30

35

Claims

1. Implantable port with a closed hollow body, the wall of which delimits its interior has a wall area formed by a puncturable, elastic membrane and a connection opening into the interior for a catheter, the tip of which faces away from the connection for insertion into a vessel to be catheterized, and with a valve which is closed in its unactuated state serves as a shut-off device on the way from the port interior to the tip of the catheter, characterized in that the valve (10, 17, 18; 32, 42) is at a distance from that for introduction into the tip to be catheterized is arranged.

2. Port according to claim 1, characterized in that the valve (32, 42) is arranged in the catheter (28).

3. Port according to claim 2, characterized in that the valve (32, 42) is arranged close to the connection (20). .- -. ^{* '}

4. Port according to claim 1, characterized in that the valve (32, 42) in the ^' connection (20) is arranged.

5. Port according to claim 1, characterized in that the valve (10, 17, 18; 32, ^" 42) is arranged in the interior (6) of the port.

6. Port according to one of claims 2 to 5, characterized in that the valve .32, 42) can be transferred into its open position by the pressure of the injection means introduced by means of the puncture cannula (9) piercing the membrane.

7. Port according to one of claims 2 to 5, characterized in that the valve (10, 17, 18) by mechanical The action of pressure can be brought into its open position by means of the puncture cannula (9) piercing the membrane.

8. Port according to claim 7, characterized in that the valve (10, 17, 18) in opposition to the membrane

(5) arranged actuating element (11; 30, 31) for transfer into its open position.

9. Port according to claim 8, characterized in that the actuating element (31) has a to the membrane (5) facing platform (30).

10. Port according to one of claims 1 to. 5, characterized in that a valve (42) which can be opened by negative pressure is connected in parallel to the valve (32) which can be opened by positive pressure.

11. Port according to claim 10, characterized in that both valves (32, 42) are arranged in the immediate spatial vicinity in one and the same flow line.

12. Port according to claim 11, characterized in that both valves (32, 42) in my detachable adapter (37) are arranged.

13. Port according to one of claims 1 to 12, characterized in that the valve (10, 17, 18; 32) has a movable piston (10) provided with a sealing surface (17), which separates the connection between the the membrane (5) adjoining area (19) of the interior (6) and catheter tip by means of an elastic element (15) in the direction of the membrane (5) against a counter-sealing surface (e.g. 18) complementary to the sealing surface (17) ) is excited.

14. Port according to claim 13, characterized in that the piston (10) forms a sealing surface (17), conver- yawing lateral surface and the complementary counter-sealing surface (18) is formed by the wall (4) of the hollow body (2) or the valve seat in the catheter or in the adapter (37).

15. Port according to one of claims 13 or 14, characterized in that between the sealing surface (23) and the counter-sealing surface (25) on the piston (10) or the wall (4) arranged elastic seal (26) is provided.

16_ Port according to one of claims 13 to 15, characterized in that the elastic element is formed by a helical spring (15).

17. Port after one. of claims 13 to 16, characterized in that the piston (10) is guided in its direction of movement by mutual sliding engagement between a recess (13) and a complementary projection (14). ■. ^'

CHANGED CLAIMS

[original claims 1-17 received by the International Bureau on December 9, 1992 (December 9, 1992) replaced by amended claims 1 and 2 (1 page)]

1. Implantable port with a closed hollow body, the wall of which delimits its interior has a wall area formed by a puncturable, elastic membrane and a connection opening into the interior for a catheter, the tip facing away from the connection for insertion into a catheter to be catheterized Vessel serves, and with a valve closed in its unactuated state as a shut-off device on the way from the port interior to the catheter tip, the valve being arranged at a distance from the tip serving for insertion into the vessel to be catheterized, characterized by a double valve consisting of a through Overpressure to open valve (32) and a valve (42) which is connected in parallel with this and open by underpressure, both valves (32, 42) being arranged in close spatial proximity in one and the same flow line, the same pressure effect of the medium of the membrane piercing Puncture cannula (9) are exposed to the injected agent and are accommodated in an adapter (37) which is connected on the one hand to the port interior and on the other hand to the catheter.

2. Port according to claim 1, characterized in that the adapter (37) is detachably arranged between the port (1) and catheter (28).