DE4445715C2 - Arrangement for inserting an implant into a blood vessel or into a body cavity - Google Patents

Description

The invention relates to an arrangement for introduction an implant into a blood vessel or into a body cavity.

It belongs to the state of the art to ver micro-coils turn, aneurysms, d. H. congenital or acquired Aus bags of blood vessels supplying the brain conclude. With this measure, the danger of blu tion and / or the size growth of such vascular bagging be eliminated.

Another area of application is the closure innate or acquired fistula connections of arteries and Veins, the occlusion of veins that drain such fistulas kidneys as well as the closure of fistulous parts of angeo  arteriovenous malformations of the brain and back mark.

Introducing a micro-spiral into a blood vessel or into a body cavity is made over a thin wire Insertion aid, which with the micro-coil through a solder bond is coupled, as well as with the help of a commercial microcatheter.

A particular problem in the context of this so-called Coil occlusions form the separation of the micro coils from the insertion aids when the micro-coils are attached to the places have been properly placed.

In this regard, it is within the scope of U.S. Patent No. 5,222,136 known to replace an insertion aid from to perform a micro-coil electrolytically. Night egg This is due to the high time required for the transfer process and in particular the ent in the electrolysis standing foreign matter particles that with the surrounding Blood flow can be carried into the vascular system.

In addition, the insertion is mechanically detached help known from an implant. This requires in A little compared to electrolytic detachment less time, but has the major disadvantage that the connection between the insertion aid and the implan did is rigid. This will not only make the implant difficult to bring, but also the verb appears little between the insertion aid and the implant resilient.

Furthermore, by the US-PS 51 08 407 an arrangement Insert an implant into a blood vessel or a Prior art body cavity where the implan Tat bodies with the interposition of a connecting link  is coupled to the distal end of an insertion aid. The connector comprises a body made of an ener gie absorbent material, which is heated, when exposed to laser light.

The implant is on the connecting link with the help of a heat-soluble adhesive attached. The separation of the Implant from the insertion aid takes place in that the Connecting element is heated by a laser beam, whereby the adhesive softens. This is a softening or melting process at a tempera tur below the melting temperature of the implant. The actual separation of implant and insertion aid then mechanically follows by the connecting link or the insertion aid is withdrawn.

A first disadvantage of this arrangement is that that a severing of the connecting material with the foreign matter particles that arise with the surrounding blood stream transported into the vascular system can be. Another disadvantage is that the duration of the peeling process at least in the range of seconds lies because the laser beam is only an indirect aid to heating of the link and thus to replace the Adhesive connection is. The time required for the removal process is therefore relatively high. It is also worrying that the Adhesive connection may be smeared again. A exact control of the removal process is not possible Lich. Here it can be due to the continuing adhä sive forces happen that the implant body when Pulling out the link moved or mitge is pulled. A needs-based completion of a Aneurysms are no longer guaranteed.

The invention is based on the prior art Task based on an arrangement for the introduction of a  Implant into a blood vessel or into a body cavity to create, after which orientation of the implant in the target area the insertion aid within a short Period can be detached from the implant without harmful foreign matter particles in the adjacent vessel system can be procrastinated.

According to the invention, this object is achieved in the features of claim 1.

The core of the invention is the use of at least one Optical fiber as a load-bearing insertion aid for one in one Vascular system or a body cavity (e.g. gallbladder, Trachea, brain chamber) to be inserted and an implant direct cutting of the same type of implant material through a laser beam. Here are implants both micro coils made of a platinum alloy in particular understood with primary and secondary helix as well Devices for keeping open, supporting or reconstructing tion of vascular lumens (stents) and devices for mo blood flow and blood distribution. Furthermore are at least under the term implants temporarily encapsulated radioactive materials for local radiation (brachytherapy) in vascular systems, Body cavities or tissues understood.

For the targeted and precise local replacement is only an extremely short expenditure of time is required.

The formation of the insertion aid from at least one Optical fiber initially has the advantage that the connector between the optical fiber and the respective Im plantat can be designed so flexibly that the one placement of an implant even over very sinuous ones Vessels is possible without doing so in an undesirable manner a force on the vessels or the surrounding tissues  transfer. Still, there is such a connection between the optical fiber and the implant possible that they also the load at a necessary removal of the implant initially located in the target area Takes into account.

The optical fiber is detached from the implant by having a laser beam on the optical fiber the implant itself is focused. Here the Laser beam activated only for a fraction of a second to become. By using an appropriate La source (especially a suitable wavelength) the laser beam can also be specifically focused that there is a safe detachment of the micro coil.

When choosing a suitable wavelength the laser beam the absorption volume of the surrounding tissue can be minimized by a laser beam. This will the risk of harmful effects of the laser beam the tissue is kept as low as possible.

The main advantage of the invention is the extremely ge rings time for the targeted local replacement of the insertion aid consisting of an optical fiber from Im implant while avoiding the release of foreign bodies Fabrics. This increases the risk of triggering through bleeding disorders in vascular territories, the actual downstream target area are reduced.

Although it is usually sufficient, the free end face the optical fiber at a right angle to the longitudinal axis separate, grind and polish as they adhere to closing areas of the implant in the longitudinal axis the optical fiber and thus the laser beam If the implant meets safety, it can accordingly the features of claim 2 be useful, the light  fiber at the distal end in a 90 ° angle Longitudinal angle deviating angles, e.g. B. at an angle beveled by 45 °. The one emerging from the optical fiber The laser beam is thus on the shortest route Separation area focused.

If a micro-spiral is made of platinum in particular Alloy to use, so the characteristics prove of claim 3 as particularly advantageous. The distal End section of the optical fiber is preferably over a Length of several turns, for example 10 to 15 Turns of the micro spiral, inserted into it and with this so connected that a common shift from Optical fiber and micro-coil within a micro catheter is guaranteed. Arrived at the target area is then only the micro-spiral in for example one Bagging of a blood vessel relative to the optical fiber pushed further and the bagging with the micro spiral backfilled. After filling the bagging, the Length section no longer required for backfilling the micro helix with the help of a laser beam separated and then by the optical fiber the body away.

Another advantageous embodiment of the invention consists in the features of claim 4. Then the Optical fiber using one at its distal Solder or face facing away from the end face Adhesive connection set on the micro coil. Here can be the outer surface of the optical fiber if necessary be layered with the inner surface of the Micro-spiral enters into an intimate liability. Definitely the solder or adhesive connection is made conical, so that there is a conical surface, the a smooth transition from the outer surface of the Optical fiber on the outer surface of the micro coil  causes. This design not only enables one pro easy retraction of the optical fiber and with these connected remaining parts of the micro-coil the removal process, but if necessary also a faultless free removal of the implant using the light guide fiber without protruding vessels or vessel walls can be injured. It is a smooth glide capable transition guaranteed.

If necessary, the optical fiber can be inserted into a protective jacket be bedded. He is preferably handled arrangement according to the invention (instrument) over a han standard microcatheter with an inner lumen of 0.2 up to 0.4 mm. The length of the micro spiral is preferred approximately between 1 and 40 cm.

The use of an optical fiber or possibly more rer optical fibers also allows before actual removal process by application of a laser with a targeted lower energy heating the bring about the respective implant and thereby a Induce blood clotting (thrombosis).

A further developing the general idea of the invention Embodiment is cha in the features of claim 5 characterizes. After that is an optical fiber with a Support sleeve covered. With the support sleeve it can advantageously act as a flat wire spiral. This ensures high pressure stability at the proximal end act. The support sleeve is at its distal end with the proximal end of the micro helix connected.

This creates a relative movement between optical fibers and micro spiral or support sleeve possible. Connects with it the advantage of an individual length separation of the Micro spiral based on the volume to be filled. Episode  Lich, a pathological cavity, for example an aneurysm to be filled in as needed. That be indicates that so much micro-helix can be inserted how therapeutically required. Then follows the targeted separation of the micro coil.  

The invention is based on in the drawing Examples illustrated embodiments explained. Show it:

FIG. 1 is a vertical longitudinal section and magnified several times an instrument for insertion of a micro-coil in a blood vessel;

Fig. 2, the introduction of the micro-coil into the blood vessel and

Fig. 3 also in vertical longitudinal section and multiple magnification a section of an instrument for introducing a micro helix in a blood vessel with optical fiber guide.

1 in FIGS . 1 and 2 denotes a microcatheter with a defined inner lumen. Through the micro catheter 1 , an optical fiber 2 is guided, which is connected to a laser source 3 .

The distal end face 4 of the optical fiber 2 is chamfered at an angle α of 45 ° to the longitudinal axis 5 of the optical fiber 2 .

The end section 6 of the optical fiber 2 is inserted into a laser section 3 facing end section 7 of a microwave 8 made of a platinum alloy. The lead length extends in the embodiment over about fifteen turns of the micro-coil 8th By a suitable coating of the optical fiber 2 a reaching adhesion of the surface 9 of the optical fiber 2 to the inner surface 10 of the micro coil 8 is achieved.

The connection of the optical fiber 2 with the micro-coil 8 is carried out by a solder 11 , which is placed conically between the end facing the micro-catheter 1 12 of the Mi coil 8 and the surface 9 of the optical fiber 2 . Due to the conical design, a conical surface 13 of the solder 11 is achieved, which ensures a protrusion-free transition from the surface of the optical fiber 2 to the outer surface 14 of the micro 8 spiral.

The free end face 15 of the micro coil 8 is also provided with a solder mass 16 . This is rounded off in such a way that the micro-coil 8 can be inserted into a body cavity without the risk of damage to the vessels and, if necessary, also pulled out again.

Is according to the representation of FIG. 2, the micro introduced helix 8 in an aneurysm 17 of a blood vessel 18 and thus fills the aneurysm 17, the laser source 3 is activated and a laser beam 19 through the optical fiber 2 of the fraction of a second on the end face 4 Optical fiber 2 focused on the micro coil 8 (see also Figure 1). By appropriate choice of the laser source 3 (in particular wavelength), the laser beam 19 separates the micro-coil 8 specifically at the fo kissed point without the adjacent Ge weave of the blood vessel 18 or the bag 17 being damaged. The optical fiber 2 is then together with the sheathed length section 7 of the micro-coil 8 from the length 20 of the micro-coil 8 filled in the bag 17 in an irregular positional orientation, so that now the microcatheter 1 is pulled together with the optical fiber 2 from the blood vessel 18 can.

FIG. 3 shows an optical fiber 21 which is arranged in a support sleeve 22 so as to be movable relative thereto. The support sleeve 22 is joined at its distal end 23 to the proximal end 24 of a micro coil 25 . The connection is marked with 26.

A microcatheter has not been shown in FIG. 3.

The relative mobility of the optical fiber 21 relative to the support sleeve 22 and the micro-coil 25 is illustrated by the arrow PF.

Due to the possibility of freely moving the optical fiber 21 in the support sleeve 22 , an individual length separation of the micro helix 25 can be carried out in relation to the volume to be filled. For this purpose, the optical fiber 21 is guided to the corresponding point and the micro coil 25 is cut through in a targeted manner.

Reference list

1 microcatheter
2 optical fiber
3 laser source
4 front side of 2nd
5 longitudinal axis v. 2nd
6 end section v. 2nd
7 end section v. 8th
8 micro coils
9 surface v. 2nd
10 inner surface v. 8th
11 Lot
12 front of v. 8th
13 surface from 11
14 outer surface of 8th
15 front of v. 8th
16 solder mass
17 bagging
18 blood vessel
19 laser beam
20 length section from 8th
21 optical fiber
22 support sleeve
23 distal end of 22
24 proximal end of 25th
25 micro coils
26 connection
α angle v. 4th
PF arrow

Claims (5)

1. An arrangement for inserting an implant ( 8 ) into a blood vessel ( 17 ) or into a body cavity, which has an elongated flexible insertion aid ( 2 ) and an implant ( 8 ) at least indirectly attached to the distal end section ( 6 ) of the insertion aid ( 2 ) summarizes, the insertion aid consists of at least one optical fiber ( 2 ) which can be coupled via its end facing away from the distal end ( 4 ) to a device ( 3 ) for generating laser beams ( 19 ) and a laser beam ( 19 ) for detaching the implant directly the implant ( 8 ) can be focused. 2. Arrangement according to claim 1, characterized in that the optical fiber ( 2 ) at the distal end ( 4 ) is chamfered at an angle (α) deviating from 90 ° to the longitudinal axis ( 5 ). 3. Arrangement according to claim 1 or 2, using a micro-helix ( 8 ) as an implant, characterized in that the optical fiber ( 2 ) with its over several turns of the micro-helix ( 8 ) extending distal end portion ( 6 ) in the laser source ( 3 ) facing end section ( 7 ) of the micro coil ( 8 ) is embedded. 4. Arrangement according to claim 3, characterized in that the micro-coil ( 8 ) and the optical fiber ( 2 ) are connected to one another by a solder or an adhesive ( 11 ), the solder having a conical surface ( 13 ) or the adhesive ( 11 ) the front end of the micro-coil ( 8 ) and the circumferential side of the optical fiber ( 2 ) is provided. 5. Arrangement according to claim 1, characterized in that the insertion aid comprises an optical fiber ( 21 ) which is of a support sleeve ( 22 ) relative to this umman telt and the support sleeve ( 22 ) is coupled to a Microwave del ( 25 ).