WO2020094620A1

WO2020094620A1 - Medical appliance, auxiliary element for use as part of such a medical appliance, and connection element for use as part of such an auxiliary element

Info

Publication number: WO2020094620A1
Application number: PCT/EP2019/080196
Authority: WO
Inventors: Halil Krasniqi; Maic Strasser
Original assignee: Halil Krasniqi; Maic Strasser
Priority date: 2018-11-07
Filing date: 2019-11-05
Publication date: 2020-05-14
Also published as: DE112019005561A5; DE202018107159U1

Abstract

Medical appliance with a probe which extends from a first end to a second end and which has a through-opening extending between these two ends and is insertable into a blood vessel (B) of a human or of an animal in such a way that its first end is located inside the blood vessel (B) and its second end is located outside the human or animal, and with an auxiliary element which has a connection element having a front end and has an expansion element arranged at the connection element, in the region of the front end of the connection element, in such a way that the expansion element, in its non-expanded state, can be pushed with the front end of the connection element through the through-opening of the probe, from the direction of the second end of the probe, such that the expansion element then adopts its position of use and, in this position of use, can be brought to an expanded state or automatically adopts an expanded state, wherein the connection element has a positioning means with respect to the probe such that, when the positioning means adopts a defined position with respect to the probe and the expansion element is expanded, the expansion element adjoins the first end of the probe in order thereby to form a rotary bearing body, arranged in the blood vessel (B), for pivoting the probe.

Description

Medical device, auxiliary element for use as part of such a medical device and connecting element for use as part of such an auxiliary element

description

The invention relates to a medical device according to the preamble of claim 1, an auxiliary element for use as part of such a medical device according to claim 16 and a connecting element for use as part of such an auxiliary element according to claim 17.

It has long been known in medicine to minimally invasively treat the inside of blood vessels, in particular arterial blood vessels. A blood vessel (usually an artery) is punctured at one point and a sluice is inserted in sections into the blood vessel such that a first end of the sluice remains within the blood vessel during treatment and that a second end of the sluice is located outside the body . This lock has a through opening. The necessary instruments are brought into the interior of the artery by means of this lock. These instruments are usually located at the end of a wire that is pushed into the blood vessel. With this method, for example, stands can be set, blood vessels narrowed or expanded, or arterial calcifications can also be removed using micro-cutters. To expand a blood vessel, the expansion elements are used in the form of balloons, which are pushed to the appropriate place by means of a wire and then filled with a saline solution via a hose that also extends through the lock.

Access is usually via a main artery in the groin, which must be punctured in a first step, then the first end of the Being able to position the sluice within the artery. This method is known to the experts and in particular to the surgeons specializing in it and need not be explained in detail here. For the following it is essential that a directional selection must be made when puncturing or at the latest when inserting the lock. This means that the sluice either points towards the heart or towards the leg from the bar. In many patients, however, starting from the access point, it is necessary to carry out treatments both on the heart side of the blood vessel and on the leg side of the blood vessel. This requires two operations, one in which the lock is oriented at the beginning of treatment so that its first end points towards the heart, and one in which the orientation of the lock is fixed in such a way that it is locked at the start of treatment first end pointing towards one leg. Carrying out two operations is of course more stressful for the patient than carrying out just one operation and is also correspondingly more expensive.

Proceeding from this, the object of the present invention is to develop a generic medical device in such a way that a blood vessel can be treated on both sides of the puncture site during only one operation.

This object is achieved by a medical device with the features of claim 1. An auxiliary element for use with a lock for forming a medical device according to the invention is specified in claim 16. A connecting element for use as part of such an auxiliary element is specified in claim 17.

The basic idea of the invention is to create a temporary pivot bearing body at the first end of the lock, by means of which the lock, the first end of which is located within the blood vessel, can be pivoted, where the pivot bearing body both slips out during the pivoting movement of the first end of the sheath as well as injury to the blood vessel is prevented. When in use, the diameter of the swivel body must be naturally larger than the diameter of the second end of the lock. That is why it is designed as an expansion body (otherwise it would not fit through the lock). In order to be able to push the expansion body through the lock, a connecting element is provided, at the front end of which the expansion element is arranged.

It is essential for the invention that the expansion element connects to the first end of the lock during its use, for which purpose the connecting element has a positioning means for positioning the connecting element with respect to the lock. This positioning means can in particular be designed as a stop. Among other things, this has the advantage that the aid can be used with locks of the prior art and that misuse is practically impossible. However, it would also be possible to use other types of positioning means. Here, for example, the positioning means of the connecting element could be part of a releasable snap-in connection. In principle, it would also be possible to provide only one marking as a positioning means. In this case, however, it would be preferable to additionally provide a locking element acting between the lock and the connecting element.

In order to create good compatibility with existing locks, it may be preferable to make the stop bell-shaped.

As already mentioned, the exact positioning of the expansion element at the first end of the lock is essential. In order to achieve this, it can be favorable for the connecting element to have a connecting section, the length of which corresponds to the length of the through opening of the lock and thus generally also to the length of the lock itself. In order to facilitate insertion into the lock, this connecting section can be essentially rigid.

It is fundamentally possible to design the expansion element in such a way that it automatically ("automatically") when it reaches its use position expanded state, for example because it is under tension. However, it will often be preferable to continue to provide an actuating element by means of which the expansion element can be brought into its expanded state. In this case, it is further preferred to design the actuating element in such a way that the expanded expansion element can also be brought back into its non-expanded state by reverse actuation of the actuating element.

According to the current state of knowledge, it is preferred that the expansion element is an elastic balloon and the connecting element is or has a line leading into this balloon. In this case, an actuating element is necessary, which in particular can be a piston-cylinder unit, that is to say a syringe. An expansion element in the form of a balloon made of a rubber-elastic material has the advantage of being easy to manufacture and of great operational reliability. In principle, however, the use of a mechanical expansion element is also conceivable. The expanded expansion element can be essentially round, but can also be designed in the form of a disk.

In the case of a mechanical expansion element, this can be designed, for example, in the form of an “inverted umbrella”, so that in this case too, the pivot bearing body formed from the expanded expansion element has a convex surface for contact with the inner wall of the blood vessel. In this case, for example, it is conceivable to dispense with an actuating element. In this context, it should be emphasized that the expansion element does not necessarily have to increase its volume when expanding (as is the case with a balloon), but it may also suffice that it expands when it expands its surface facing the blood vessel wall.

If the expansion element is designed as a balloon, it is preferred that the connecting element has a shut-off valve, by means of which the connection between the actuating element and the balloon can be interrupted, so that an unintentional Visible reflux of liquid (usually a saline solution) from the balloon and thus premature reduction of the expansion element is excluded. In order to improve the visibility of the “rotary slide” in an X-ray monitor, it can be preferred that at least parts of this rotary bearing are made of metal. For this purpose, in particular the first end of the lock and / or the front end of the connecting section of the connecting element can carry a metal element, provided that these components do not consist of metal anyway. Furthermore, the expansion element can consist entirely or partially of metal or can also carry a metal element. In the event that the expansion element is a balloon, it is particularly preferable here that at the front end - preferably on the inside of the balloon - a small metal element is connected to the balloon, for example glued.

Further preferred exemplary embodiments and advantages result from the further subclaims and from the exemplary embodiment now described.

The invention will now be described in more detail using a preferred exemplary embodiment with reference to the figures. Here show:

Figure 1 A lock according to the prior art

FIG. 2 the lock from FIG. 1 and a so-called soul, which is passed through the lock,

Figure 3 shows an auxiliary element according to the invention for use with the

Lock of Figure 1 in an initial state,

Figure 4 shows the auxiliary element of Figure 3 in a state in which its

Expansion element is expanded, 5 shows the lock of FIG. 1 in a state of use in which its first end is located within a blood vessel,

6 shows the lock of FIG. 5 and the auxiliary element of FIG. 3, a connecting element of the auxiliary element being in a defined position with respect to the lock,

FIG. 7 that shown in FIG. 6, in a state in which the expansion element of the auxiliary element is in an expanded state,

8 to the one shown in FIG. 7 while carrying out a directional change, FIG. 13 changing the lock, FIG. 14 the lock as shown in FIG. 12 after the auxiliary element has been removed again.

FIG. 1 shows a so-called lock 10, as is known in the prior art. This lock 10 extends from a first end 10a to a second end 10b and has a through opening which extends over the entire length of the lock 10, that is to say from the first end 10a to the second end 10b. A front section 12 of the lock is designed essentially in the form of a straight tube and a rear section 14 of the lock 10 is widened with respect to this tubular front section 12. As a rule, the through opening widens, which facilitates the insertion of elements into the second end 10b of the lock 10.

FIG. 2 shows the lock of FIG. 10, a so-called core 20 being introduced into this lock 10. This has a greater length than the lock, so that when the core 20 is pushed through the lock 10, a tip 22 of the core 20 protrudes from the first end 10a of the lock 10 and a handle 24 of the core 20 outside the second End 10b of the Lock 10 is positioned (so in a way behind the lock). The tip 22 serves to puncture a blood vessel.

FIGS. 3 and 4 show a preferred exemplary embodiment of an auxiliary element 30 according to the invention, which is used together with the lock 10. This auxiliary element 30 has three basic elements, namely a connecting element 40, an expansion element 50 in the form of a balloon and an actuating element 60 in the form of a piston-cylinder unit, ie in the form of a syringe.

The connecting element 40 can be regarded as consisting of a connecting section 42 and a connecting section 46. The transition between these two sections is formed in the form of a stop 44, which is bell-shaped in the exemplary embodiment shown (and this is also preferred). The connecting element 40 extends from a front end 42a (this is also the front end of the connecting section 42) to a rear end 46b (this is also the rear end of the connecting section 46). The expansion element 50, that is to say the balloon in the exemplary embodiment shown, is arranged at the front end 42a. FIG. 3 shows the expansion element 50 in the unexpanded state.

Since the unit comprising the lock 10 and the connecting section may have to withstand relatively large bending forces when reversing, as will be described later, it is advantageous to manufacture at least the connecting section 42 from a material of high rigidity, for example from metal. This also has the advantage of good visibility in an X-ray monitor.

With regard to the visibility in an X-ray monitor, it can also be advantageous to arrange a small metal element on the balloon, preferably at its front end. In order to ensure that it does not detach from the balloon and enter the bloodstream, it is preferably located on the inside of the balloon. The actuating element 60 is either directly or via an intermediate piece, for example in the form of a hose, with the connecting element 40. In the latter case, this intermediate piece also belongs to the reel element 30.

The connecting element 40 is hollow throughout, so that liquid can be pressed by the actuating element 60 into the expansion element 50 designed as a balloon and pulled out of it again. This connection can be interrupted by means of a shut-off valve which is arranged in the connection section 46. The actuating lever 48 of this check valve is shown in the state “open” in FIG. 3.

The length of the connecting section 42 corresponds essentially to the total length of the lock 10 and the outer diameter of the connecting section 42 is somewhat smaller than the inner diameter of the front section 12 of the lock 10. This means that the connecting section 42 from the second end 10b of the lock 10 can be inserted into it until the stop 44 of the connecting element 40 bears against the second end 10b of the lock. In this state, the front end 42a of the connecting section 42 and thus also the (initially unexpanded) expansion element 50 - here the balloon - Arranged essentially flush at the first end 10a of the lock 10.

As shown in FIG. 4, by actuating the actuating element (syringe) 60, the expansion element (balloon) 50 can be brought into an expanded state. In this state, the shut-off valve can be closed (FIG. 4).

With reference to FIGS. 5 to 12, the meaning and the mode of operation of the reflow element 30 according to the invention will now be explained.

FIG. 5 shows an initial state in which the first end 10a of the sluice 10 is located in a blood vessel B, in particular a main artery in the groin. The lock 10 points in one direction, either in Towards the heart or towards a leg. In this initial state, the lock 10 is “empty”, that is to say there is neither a soul 20 nor a wire in it. In this state, the connecting section 42 of the connecting element 40 is inserted into the lock 10 from the second end 10b until the stop 44 of the connecting element 40 of the auxiliary element 30 comes into contact with the second end 10b of the lock 10, so that the connecting element 40 has a defined position with respect to the lock 10 Because of the fact described above that the connecting section 42 of the connecting element 40 has the same length as the lock 10, in this state the front end 42a and thus also the expansion element 50 are essentially flush with the first end 10a of the lock 10 arranged. While the connecting section 42 is pushed through the lock 10, the expansion element 50 is of course in its unexpanded state, otherwise it would not fit through the lock 10, in particular not through its front section 12. The state just described is shown in FIG. 6.

Next, the actuating element 60 is actuated so that the expansion element 50 reaches its expanded state. In the specifically shown preferred embodiment, this means that a saline solution is pressed into the balloon by means of the syringe, so that the balloon expands. The check valve is then guided into its ^' closed position by means of the lever 48. This is shown in Figure 7. This results precisely at the first end 10a of the lock 10, a rotary bearing body, which prevents the lock 10 from being pulled out of the blood vessel B and defines a pivot point. This swivel body also prevents injury to the blood vessel.

As shown in FIGS. 8 to 12, the orientation of the lock can now be reversed, wherein, as mentioned, the expanded expansion element 50 serves as a kind of bearing point. After the change of direction has been completed, the shut-off valve is opened again by means of the lever 48 and the saline solution is withdrawn from the balloon-shaped expansion element 50 by means of the syringe (see FIG. 13 in this regard).

Now the connecting section 42 of the connecting element 40 is pulled out of the lock 10 again, so that the lock 10 is now available for the introduction of other elements, in particular treatment elements. For example, FIG. 14 shows that the core 20 extends through the lock 10 again.

Instead of table salt, a contrast medium can be used to fill the balloon. Since both the balloon and the positioning element are filled with liquid - here with the liquid contrast agent - during rotation, very good monitoring of the rotation process is possible in this case by means of a suitable imaging method, in particular by means of X-ray.

Alternatively or additionally, parts of the "pivot bearing" can consist of metal, as has already been mentioned.

Reference numerals list

10 lock

10a first end

10b second end

12 front section

14 rear section

16 through opening

20 soul

22 top

24 handle

26 bell-shaped stroke of the soul

30 auxiliary element (expansion element)

40 connecting element

42 connecting section

42a front end

44 bell-shaped stop

46 connection section

46b rear end

48 Lock valve lever

50 expansion element (balloon)

60 Actuator (syringe; piston-cylinder unit) B blood vessel

Claims

1. Medical device with

a lock (10) extending from a first end (10a) to a second end (10b), which has a passage opening extending between these two ends (10a, 10b) and which thus enters a blood vessel (B ) of a person or an animal, that its first end (10a) is inside the blood vessel (B) and its second end (10b) is outside the person or animal, and an auxiliary element (30), which is a front End (42a) having connecting element (40) and an expansion element (50) arranged in the region of the front end (42a) of the connecting element (40) on the connecting element (40) such that the expansion element (50) in In its unexpanded state, the front end (42a) of the connecting element (40) can be pushed from the second end (10b) of the lock (10) through the through opening of the lock (10), so that the expansion element (50) then assumes its position of use and in this position of use can be brought into an expanded state or automatically assumes an expanded state, characterized in that the connecting element (40) has a positioning means with respect to the lock (10) such that when the positioning means has a defined position with respect to the Takes lock (10) and the expansion element (50) is expanded, the expansion element (50) connects to the first end (10a) of the lock (10), so as to arrange a rotating body in the blood vessel (B) for pivoting the lock (10) to build.

2. Medical device according to claim 1, characterized in that the positioning means is a stop (44).

3. Medical device according to claim 2, characterized in that the stop (44) is bell-shaped.

4. Medical device according to one of the preceding claims, characterized in that the connecting element (40) has a connecting section (42), the length of which corresponds to the length of the through opening of the lock (10)

5. Medical device according to claim 4, characterized in that the connecting section (42) is substantially rigid.

6. Medical device according to claim 5, characterized in that the connecting section (42) consists of metal.

7. Medical device according to claim 4 or claim 5, characterized in that a metal element is arranged in the region of the front end (42a) of the connecting section (42)

8. Medical device according to one of claims 4 to 7, characterized in that the outer diameter of the connecting portion (42) is slightly smaller than the smallest inner diameter of the through opening of the lock (10).

9. Medical device according to one of the preceding claims, characterized in that the auxiliary element (30) further comprises an actuating element (60) for the expansion element (50), by the actuation of which the expansion element (50) is brought into its expanded state becomes.

10. Medical device according to claim 9, characterized in that the expansion element (50) is an elastic balloon and that the connecting element (40) is a line opening into this balloon or has one.

11. Medical device according to claim 9 or claim 10, characterized in that the actuating element (60) is a piston-cylinder unit.

12. Medical device according to one of claims 9 to 11, characterized in that the connecting element (40) has a check valve, by means of which the connection between the actuating element (60) and the balloon can be interrupted.

13. Medical device according to one of claims 4 to 8 and according to claim 13, characterized in that the check valve is arranged in a connecting section (42) connecting section (46) of the connecting element (40).

14. Medical device according to one of the preceding claims, characterized in that a metal element is arranged in the region of the first end (10a) of the lock.

15. Medical device according to one of the preceding claims, characterized in that the expansion element (50) consists at least partially of metal or that a metal element is arranged on the expansion element (50).

16. Auxiliary element (30) for use as part of a medical device according to one of claims 1 to 15.

17. Connecting element (40) for use as part of an auxiliary element (30) according to claim 16.