WO2006032290A2

WO2006032290A2 - Implant insert system

Info

Publication number: WO2006032290A2
Application number: PCT/EP2004/010611
Authority: WO
Inventors: Achim Flesser; Ralph Bodenburg; Ronald Kontek
Original assignee: Dendron Gmbh
Priority date: 2004-09-22
Filing date: 2004-09-22
Publication date: 2006-03-30
Also published as: WO2006032290A3

Abstract

The invention relates to a combination for positioning a medical implant (14) in a patient body. Said combination comprises a storage container (1) for receiving the implant (14) in a stored state thereof, a catheter end-piece (17) which forms the proximal end of the catheter by the connection therewith and an insertion device (6). The insertion device (6) is removably connectable with the catheter end-piece (17) and with a storage container (1) in such a way that the implant (14) is transferable from the storage container (1) into the insertion device (6) and therefrom to the catheter by means of a guide wire (15) disposed proximally to the implant (14). The inventive combination simplifies handling during the insertion of the implant (14) in to catheter. In addition, the implant (14), particularly a stent, is storable in the storage container (1) for prolonged periods of time in the released non-compressed state thereof, when the internal diameter of the storage container (1) is greater than the internal diameter of the insertion device (6) and of the catheter lumen.

Description

Insertion system for implants

The invention relates to a system for placing a medical implant in the body of a patient with a storage container, comprising an internally hollow tube for receiving the implant in the storage state, which can be passed through a catheter for introduction into the blood vessel system of the patient to its destination.

It is known from the prior art to treat vascular constrictions (stenoses) through the use of stents (vascular endoprostheses, vascular stents), which are inserted into the stenotic area and there hold open the vessel lumen by their inherent rigidity. It is also known to use such stents for occluding Gefäßwandaussackacks (aneurysms) or fistulas.

Conventionally, balloon-sterilizable stents have been used. Especially for use in particularly small-lumen, intracranial vessels, however, the use of self-expanding stents has proven that are made of shape memory materials. These have a grid or mesh structure and are first passed in the collapsed state through a catheter to the destination, where they widen due to the change in temperature (thermal shape memory effect) or by the elimination of the force exerted by the catheter mechanical (superelasticity). Especially for use in small-lumen vessels, the stent made of a shape memory material should initially be present as an elongated, highly compressed filament and only when it exits the catheter through

the change in temperature or elimination of the coercion previously exerted by the catheter will take on the final structure.

In handling such stents known from the prior art, various things are disadvantageous. Since considerable time periods of up to several years can be present between the production and the use of a stent, the stent must be stored in a specially provided storage container in a highly compressed form for a correspondingly long period of time. However, such storage is not without problems, as this subsidence may occur that hinder the adoption of the final structure of the stent when pushed out of the catheter at the target location of the blood vessel. If the stent, after a long period of storage at the target site, is no longer able to assume its intended shape and circumference, this may result in the stent having its purpose, ie. H. keeping open the vessel lumen, no longer fulfilled.

In addition to subsidence, attachment problems may also occur in the form that the compressed stent adheres to the inner walls of the bearing tube after prolonged storage. Bearing tubes of the prior art are usually made of a comparatively soft material, so that the mesh structure of the stent can be virtually reproduced on the bearing tube. Due to this sticking, it may be difficult to push the stent out of the storage tube, and often only after repeated pulling back and forth.

The alternative of storing the stent in incomplete or incompletely compressed form is problematic because it greatly impedes insertion of the stent into the proximal region of the catheter during treatment. Anyway, the current state of the art is a difficult one

Activity, the stent with the attached guidewire in the

Introduce catheter, which usually can not be performed by the attending physician alone, but only in pairs. In this respect, there is also a need here, a way to create the stored stent in simpler

Way in the proximal end portion of a catheter. This object is achieved according to the invention by a combination for placing a medical implant in the body of a patient with a storage container having an internally hollow tube for receiving the implant in the storage state, wherein the combination further comprises a catheter end, which when connected to a catheter for insertion in the blood vessel system of the patient forms the proximal end of the catheter, so that the implant can be passed through the catheter to its destination, and an insertion device having an internally hollow tube, wherein the insertion device at at least one end of the tube with both the Katheterendstück is detachably connectable with at least one end of the bearing device in such a way that the implant with the aid of a guide wire located proximally on the implant or other insertion aid when connecting the storage container with the insertion of the storage container i n the introducer and, when connecting the introducer with the Katheterendstück, which is simultaneously connected to the catheter, can be transferred from the introducer into the catheter.

Such a combination offers the possibility of storing a medical implant, for example a stent, in the storage device and of introducing it into the proximal end region of a catheter in a simple manner.

For this purpose, the implant is first transferred from the storage container into the insertion device, before the catheter end piece with catheter is connected to the insertion device after removal of the storage container, in order to be able to introduce the implant into the catheter. In particular, the combination according to the invention also offers the possibility of introducing a medical implant alone into the proximal end region of a catheter without the help of other persons, without taking an excessive risk of damaging the implant during insertion. The introducer can be fixed in the catheter endpiece so that it no longer moves in the axial direction in the catheter endpiece.

Conveniently, the storage container is delivered in a mold connected to the introducer, wherein in the storage container, the medical implant is located and located at the proximal end of the implant Guidewire extends through the inside hollow tube of the introducer. This compilation can be packaged sterile and stored for a longer period of time. The catheter end piece also belonging to the combination according to the invention is characterized in that it has a possibility for producing a releasable connection with the insertion device and at the same time can be connected to a catheter.

When the catheter tip is connected to the catheter, it forms the proximal end of the catheter. This connection may be permanent, such that the catheter tip is part of the catheter itself, or temporarily. In the latter case, the catheter end piece serves as an adapter for a catheter for the insertion device according to the invention.

A catheter which is permanently connected to the catheter end has the advantage that it is precisely matched to the combination according to the invention and can be used correspondingly directly. Such a catheter may be supplied directly for use as part of the combination of the invention. The connection to an additional catheter end piece is not necessary in this case, since this is already part of the catheter itself.

Alternatively, it is also possible to form the catheter tails as adapters that can be connected to a commercially available catheter to form the proximal end of the catheter. This makes it possible to manufacture catheter end pieces so that they are adapted on the one hand for use with a particular catheter and on the other hand can be used as part of the combination according to the invention. The adapters are conveniently provided with a label that provides information about which catheter they are used.

In the context of this invention, the terms "proximal" and "distal" are understood to mean that "distal" refers to the orientation to the outside of the target organism, ie to the surgeon

Surgeon away to the destination within the organism. The use of Terms in the description of the individual parts of the combination according to the invention itself relate to the intended use.

As medical implants according to the invention in addition to stents also so-called occlusion helices are in question, which serve the occlusion of body cavities or vessels such as arteries, veins, fallopian tubes or vascular malformations (eg vascular aneurysms). Such occlusion coils are usually controlled with the aid of an endovascular guide wire in a catheter through the blood vessel system and advanced at the destination from the catheter into the cavity to be occluded and deposited there. Subsequently, the separation of the occlusion helix, which can be done in different ways. In particular, the process of electrolytic corrosion has proven itself.

Although the problem of subsidence phenomena described above may be less relevant in the case of occlusion helices, difficulties still arise in introducing the occlusion helix into the proximal end region of the catheter. Due to the filigree design of a Okklusionswendel just for use in the intracranial region can be easily introduced into the proximal end of the catheter when introducing the Okklusionswendeln slight damage to the occlusion helix, such. B. small kinks or bends occur that jeopardize the functioning of the occlusion helix in the body cavity to be closed. In the prior art, occlusion coils are usually stored in a sheath. To introduce the occlusion helix into the proximal end region of the catheter, the occlusion helix is transported with the aid of a proximally attached guidewire into the proximal end region of the catheter, where it is pushed out of the sheath. This positioning is extremely difficult and can only be done in pairs. In particular, it may happen that the occlusion coil is pushed out of the sheath too early and therefore can no longer be inserted into the narrow catheter lumen, because the occlusion helix twists or kinks in the further-lumen end region of the catheter after removal of the sheath. Accordingly, it makes sense to use the combination according to the invention also in this area. When using the combination according to the invention for stents, in which the long storage in compressed, elongated form is problematic, it is advantageous to form the inner diameter of the storage container for receiving the implant larger than the inner diameter of the insertion device 5. For this purpose, the larger inner diameter of the storage container must pass continuously into the smaller diameter of the insertion device, which can be done in various ways. One possibility is to provide a portion in the hollow tube of the storage container in the direction of the end intended for connection to the insertion device, which tapers towards said end. Another alternative or additional possibility is to conically form the transition from the storage container to the insertion device. In both cases, this results in that the tapered inner surfaces of the storage container or the inner cone surfaces exert a force in the radial direction on the implant transferred from the storage container to the insertion device, whereby the implant, in particular the stent, is compressed as far as it is for the passage of the implant through the catheter is expedient. A stent can thus be stored for a long time in non-compressed or only slightly compressed form, so that the occurrence of subsidence, the acceptance of the

2o provided form in the target vessel can be practically ruled out. Only shortly before use of the stent is this compressed so much that it can be advanced through the catheter to the destination, even if it is particularly Englumige, z. B. intracranial or cerebral vessels. The transfer of the implant from the

25 storage container into the introducer is usually done by pulling on the proximal stent located on the guide wire, while the transfer takes place in the proximal end of the catheter by advancing the guide wire. Instead of an ordinary guidewire other, essentially identical purposes serving insertion aids

3o be used.

Compression of the stent by pulling on the proximally attached guidewire is also advantageous in that it virtually eliminates the occurrence of bends during compression. This is due to the fact that the stent is the first in the proximal, with the guide wire connected area is compressed, where the stent is held under tension while pulling and therefore can not deviate from the target direction. In contrast, compressing the stent during advancement would risk bending or twisting of the stent in the initially compressed distal region, which is not secured by a guidewire.

It may also be advantageous in the area of the occlusion helixes to make the inner diameter of the storage container larger than the inner diameter of the insertion device, since more and more occlusion helices are used, which are provided for the formation of a superordinate secondary structure in the aneurysm, which forces them after eliminating a constraint exerted by the catheter assume by itself. In such Okklusionswendeln it may be useful to keep them in at least partially relaxed state in the storage container and only shortly before use to compress so that they can be passed through the catheter.

Since the implant is received at the same end of the introducer of the storage container, where it is later delivered via the Katheterendstück to the catheter, and the transition from the introducer into the Katheterendstück must be designed so that on the one hand the transfer by advancing the Guidewire is easily possible and on the other hand, the stent after introduction into the catheter has its intended compressed shape. To ensure this, the inner diameter of the catheter tip and the catheter should not be larger than the inner diameter of the introducer. In this way it is also ensured that the entire catheter lumen can be utilized for the implant. An additional enclosure around the implant, in particular the stent in order to keep it in a compressed form, is thus no longer necessary. By dispensing with an additional enclosure, the diameter of the catheter itself can be kept smaller, which is especially in the introduction of the catheter in particularly kleinlumige

Vessels is advantageous. The preparation of the detachable connection between the introduction device and the storage container or catheter end piece can be produced in various ways familiar to the person skilled in the art. In particular, offers a plug and / or screw connection. A connector can be made by 5 matched elements, for example by conical connectors and matched recordings.

Especially in the field of medical technology, the so-called Luer system has proven itself, which is a standardized conical connection, in which a slightly conical connector is inserted into a designated lo recess in the counterpart. In order to optimally secure the connection thus produced against loosening, a screwing system is often additionally used, which is called the Luer-Lock principle. In this case, the male connection piece additionally has an internal thread, so that after being placed on the female connection piece, an i5 locking takes place by turning. Such a luer-lock system is well known to those skilled in the field of medical technology, for example in the field of syringes and cannulas.

For use in the context of the present invention, the introducer may have a male luer-lock connector while the catheter end and storage containers are provided with corresponding female luer connector counterparts. Alternatively, it is also possible to equip the introducer with a female Luer connector and the Katheterendstück and the storage container with a male Luer-lock connector.

25 Another possibility for producing the compounds is to provide the introducer with a conical element that can be inserted into a corresponding receptacle in the storage container and / or Katheterendstück that a non-positive and / or positive connection is brought about. The positive engagement is thereby through each other

30 coordinated forms, the adhesion caused by frictional forces. Similar bonding techniques are known for closures of apothecary bottles. The items to be joined can easily put on each other, but only with the application of a certain amount of force to be pulled apart again. The positive connection can additionally z. B. be further improved by slight elevations or depressions in the region of the conical element and the corresponding recordings.

In addition, it is advantageous to improve the handling of the storage container and / or the insertion on its outer sides equipped with radially projecting handles. This makes the combination according to the invention even easier to handle for the surgeon. In particular, the rotatability of the items is improved, which may be necessary to release the connection.

Typically, the surgeon only leaves the introducer in communication with the proximal end of the catheter at the beginning of the procedure and removes it after overcoming about half the way to the medical implant placement site.

In addition to the described combination, the invention also contemplates the storage container, introducer and catheter endpiece for use as part of a combination as described above and a catheter permanently attached to such a catheter endpiece.

The invention is intended primarily for use in the treatment of humans but may well be applied to animals.

The invention will be further explained with reference to the attached figures. Show it:

FIG. 1 shows a storage container according to the invention in cross section;

Figure 1a shows an alternative embodiment of a storage container according to the invention in cross section; Figure 2 shows an insertion device according to the invention in cross section;

Figure 2a shows an alternative embodiment of an insertion device according to the invention in cross section;

Figure 3 shows a storage container according to the invention, which is connected to an insertion device according to the invention, in cross-section and the transfer of a stent from the storage container into the insertion device;

FIG. 4 shows a catheter end piece according to the invention, which is connected to an insertion device according to the invention, in cross section and the transfer of a compressed stent from the insertion device into the catheter end piece and

FIG. 5 shows an alternative catheter end piece according to the invention, which is provided with an alternative inventive

Insertion device is connected, in cross-section and the transfer of a compressed stent from the introducer into the

Catheter tip.

The storage container 1 of Fig. 1 consists primarily of a hollow tube 2 inside, which has a tapered transition 3 at the provided for the connection with the insertion device side, within which the inner diameter of the storage container 1 is significantly reduced. An implant located in the storage container 1 is correspondingly compressed in its cross section when passing through the transition 3 and brought to a diameter as it is suitable for insertion into the insertion device. At the same time, the stent, which usually has a grid or mesh structure, is stretched. Furthermore, the storage container 1 for connection to the insertion device on a Luer connector 4, which serves to receive a corresponding counterpart of the insertion device. On its outer side, the Luer connector 4 has a thread, so that a lock can be made when connected to a corresponding Luer-Lock connector. Finally, the storage container 1 also includes gripping pieces 5, which improve the handling of the storage container 1.

In Fig. 2, an insertion device 6 is shown in cross section, which can be used in combination with the storage container 1 of FIG. The insertion device also has an inside hollow tube 7, which serves to receive the stent in a compressed form. Furthermore, the insertion device 6 comprises at its intended for connection to the storage container 1 end a Luer-lock connector 8, which serves the connection with the corresponding counterpart 4 of the storage container 1 and the Katheterendstücks and is fixable by locking by means of the screw system , Finally, the insertion device 6 includes additional grips 9, which additionally improve the handling.

In Fig. 1a, an alternative embodiment of a storage container 1 is shown, which can be connected via a plug connection with the insertion device 6 of Fig. 2a. For this purpose, the storage container 1 at its intended for connection to the insertion device 6 end a straight portion 13 into which a matching connector 12 of the insertion device 6 can be inserted.

Fig. 2a shows the corresponding insertion device 6 for the storage container 1 of Fig. 1a. This has an elongated portion 12 which can be inserted into a designated recess 13 of the storage container 1, to connect the two parts together. In addition, the insertion device 6 also has a union nut 8 in the manner of a Luer lock connection piece, which serves for fixing with the counterpart 4 of the storage container 1. The elongate portion 12 may also be a tube which is fixedly connected to the insertion device 6. The Of course, plug connection does not have to be straight, as shown here, but may also have a cone shape.

In Fig. 3 the connection of storage container 1 and insertion device 6 is shown. In this case, an implant 14, in particular a stent, is located in the storage container 1, to which a guide wire 15 is attached in the proximal region. This guide wire 15 extends through the lumen of the storage container 1 and the insertion device 6, so that the surgeon can pull the implant 14 by means of the guide wire 15 in the direction of the arrow 16 from the storage container 1 into the insertion device 6. In this transfer, the implant 14 must pass the tapered portion 3, whereby the inner surfaces of the storage container 1 exert a corresponding force on the implant 14, which converts this into a compressed, elongated shape. After the transfer, the implant 14 has a cross-section which is suitable for insertion into the insertion device 6 and ultimately also the catheter and essentially corresponds to the inner diameter of the insertion device 6.

FIG. 4 shows the transfer of the implant 14 from the insertion device 6 into the catheter end piece 17. Catheter end piece 17 and insertion device 6 are in turn connected to each other by a luer lock connection system. o The compressed stent 14 is pushed by means of the proximally mounted guide wire 15 in the direction of the arrow 18 from the insertion device 6 into the catheter end piece 17. The inner diameter of the inside hollow tube 7 of the introducer 6 is in line with the inner diameter of the Katheterendstücklumens 19 so that the implant 14 no longer changes its cross section in the transfer. The catheter tip 17 may be connected to a catheter (not shown) in the form of an adapter or may be an integral part of the catheter. Once the implant 14 is inserted far enough into the catheter, the connection of the insertion device 6 and catheter end piece 17 can be released again and the insertion device 6 removed.

Finally, FIG. 5 shows the transfer of the implant 14 from the insertion device 6 into the catheter end piece 17 according to an alternative embodiment Embodiment shown. In this case, the insertion device 6 has a conical element 10, which is suitable in a corresponding receptacle 20 in the catheter end piece 17. Again, the inner diameter of the inside hollow tube 7 of the insertion device 6 coincides with the inner diameter of the Katheterendstücklumens 19. On a Luer-lock connection or other Verschraubungssystem was omitted here, since the connection between the insertion device 6 and catheter end piece 17 is ensured by force and positive engagement. It makes sense that the storage container 1 should also have a recess corresponding to the receptacle 20. Moreover, the handling of this embodiment corresponds to that of FIG. 4th

- Claims -

Claims

claims

A combination for placing a medical implant (10) in a patient's body

- A storage container (1) having an internally hollow tube (2) for

Ingestion of the implant (14) in the storage state, d a d u c h e c e n e s that the combination of

a catheter end piece (17) which, when connected to a catheter for introduction into the blood vessel system of the patient, receives the proximal end of the patient

Forming catheter, wherein the implant (14) is guided through the catheter to its destination, and

an insertion device (6) having an inside hollow tube (7), wherein the insertion device (6) at at least one end of the tube (7) with both the Katheterendstück (17) and at least one end of the bearing device ( 1) is releasably connectable in such a way that the implant (14) by means of a guide wire (15) or other insertion aid located proximally on the implant (14) on connection of the storage container (1) with the insertion device (6) from the storage container (1 ) in the introducer (6) and in connection of the introducer (6) with the Katheterendstück (17), which is simultaneously connected to the catheter, from the insertion device (6) into the catheter can be transferred.

2. Combination according to claim 1, characterized in that the inner diameter of the storage container (1) for receiving the implant (14) is greater than the inner diameter of the insertion device (6).

3. A combination according to claim 2, characterized in that the inside hollow tube (2) of the storage container (1) in the direction of the for

Connection with the insertion device (6) provided end tapered.

4. A combination according to claim 2 or 3, characterized in that the transition from the storage container (1) to the insertion device (6) is conical, so that the conical inner surfaces a force in the radial direction o on the from the storage container (1) in the insertion device ( 6) transferred implant (14) exercise.

5. Combination according to one of claims 1 to 4, characterized in that the insertion device (6) with the storage container (1) and / or the Katheterendstück (17) via a plug connection is connectable.

6. Combination according to one of claims 1 to 5, characterized in that the insertion device (6) with the storage container (1) and / or the Katheterendstück (17) via a screw connection is connectable.

7. A combination according to claim 5 or 6, characterized in that the o introducing device (6) with the Katheterendstück (17) and the

Storage container (1) via a Luer system (4, 8) is connectable.

8. A combination according to claim 7, characterized in that the insertion device via a male luer lock connector and the catheter end piece (17) and the storage container (1) have female Luer- 5 connectors.

9. A combination according to claim 7, characterized in that the insertion device (6) via a female Luer connector and the Kathθterendstück (17) and the storage container (1) have a male Luer-lock connector.

10. A combination according to any one of claims 1 to 9, characterized in that the insertion device (6) has a conical element (10) for producing a releasable non-positive and / or positive connection in a storage container (1) and / or in the Katheterendstück (17) provided receptacle (20) is insertable.

1 1. A combination according to any one of claims 1 to 10, characterized in that the catheter end piece (17) is permanently connected to the catheter.

12. A combination according to any one of claims 1 to 10, characterized in that the catheter end piece (17) is designed as an adapter for the proximal end of a catheter.

13. Combination according to one of claims 1 to 12, characterized in that the implant (14) is a stent or an occlusion helix.

14. Combination according to one of claims 1 to 13, characterized in that the storage container (1) and / or the insertion device (6) on their outsides on radially projecting grips (5, 9) have.

15. Storage container for use as part of a combination according to one of claims 1 to 14, characterized in that the storage container (1) with the insertion device (6) is releasably connectable at least one end.

16. An insertion device for use as part of a combination according to one of claims 1 to 14, characterized in that the

Insertion device (6) with the storage container (1) is releasably connectable to at least one end.

17 catheter end piece for use as part of a combination according to one of claims 1 to 14, characterized in that the catheter end piece (17) with the insertion device (6) is releasably connectable.

18. A catheter, characterized in that the catheter comprises a catheter end piece (17) for use as part of a combination according to one of claims 1 to 14 as a component and is permanently connected thereto.

- Summary -