DE102008007453A1 - feeder - Google Patents

Abstract

The invention relates to a feed device (1, 14, 21, 28, 38) for feeding a guide device (7) into a passage opening (6) of a medical treatment device (2, 30). The feed device (1, 14, 21, 28, 38) has a guide device (11, 29) which guides the guide device (7) as it is fed into the feed device (1, 14, 21, 28, 38) and a connecting device (11). 9, 32) connecting the medical treatment device (2, 30) with the delivery device (1, 14, 21, 28, 38) in the correct position.

Description

The The invention relates to a feeding device for feeding a guide into a through hole of a medical Treatment device. The invention further relates to an assembly, which such a delivery device and a medical Treatment device comprises. In some minimally invasive examination methods or in some interventional treatment procedures, in particular in interventional cardiology and radiology it happens that for the examination method or the treatment method Several instruments are used, with the instruments being partly condition each other. For example, a must first first instrument introduced into the body of the patient become. This then serves as a guiding and guiding instrument for the following second instrument.

One An example of this is the so-called percutaneous transluminal coronary angioplasty (PTCA). One of the usual procedures is that first a leadership catheter over the inguinal artery or the lower arm artery led to the heart becomes. With the help of this leadership catheter will turn a very thin wire through the narrowed area or through pushed the blocked site. This wire then serves as a guide wire, over which the balloon catheter to be treated Place is led. In this sense, the guiding catheter the requirement for the guidewire, and the guidewire is in turn the prerequisite for the balloon catheter.

Around be able to push the balloon catheter to the site to be treated, It is first necessary to do this outside of the patient's body on the guidewire. For this purpose, the usually elongated balloon catheter in his (radial) center on a thin opening channel. Because of the small space in the blood vessels both guidewire and opening channel as possible thin designed, designed The threading as difficult in practice. Experienced doctors often suffer from presbyopia. Young doctors are on the other hand, because of the lack of routine often nervous and tend to nervous tremor (trembling). Come in addition, that in some operations a few minutes about survival or decide the death of the patient, so that moreover, a great time pressure on the doctor can load.

The currently most practiced manual threading is therefore burdened with obvious disadvantages.

To avoid the problems of threading, guide catheters with integrated balloon have already been proposed. Due to the already located from the outset on the guide catheter balloon threading the balloon is no longer necessary. Such a catheter is for example in DE 33 26 648 A1 , in DE 2 119 172 AS or in DE 696 29 167 T2 described. However, it is disadvantageous in such guide catheters with integrated balloon that they usually have to be made relatively thick. As a result, use of such guiding catheter with integrated balloon is problematic, especially in the case of severe narrowing or relatively small blood vessels. In addition, such catheters are usually quite expensive, which runs counter to the efforts to cost containment in the health sector. In addition, it may happen that the guidewire is not soft or hard enough for the probing of the respective Gefassengstelle, so that this concept several wires for the same balloons would be kept, which would inter alia, a corresponding storage result and would be impractical accordingly. In addition, despite all this, a change to another balloon catheter or another stent applicator may become necessary, so that such a system usually does not provide any real help in everyday clinical practice.

In DE 10 2005 007 585 A1 is a funneled closed container for medicines. In order to avoid contamination or germination of the drug, the container has only a small opening, which can optionally be reversibly opened by means of an actuating element. In order to simplify the immersion of the medical instrument in the container, a kind of funnel is provided in the region of the container opening. The purpose of the container requires that a stuck through the medical instrument is not possible. In addition, the diameter of the opening of the container is chosen to be relatively large so that various instruments can be inserted into the container. The diameter of the opening of the container and the diameter of the medical instrument are thus not matched.

The The object of the invention is to supply a Guide in a through hole of a medical Treatment device, in particular the threading of a Balloon catheter to simplify a guidewire.

For this purpose, a supply device for feeding a guide into a through-opening of at least one medical treatment device is proposed, which has a guide device which guides the guide when it is fed into the delivery device and which further comprises a connection device which the medical Be handling device at least partially absorb connects with the guide device. When using the delivery device, the user is assisted in inserting the guiding direction into the medical treatment device in such a way that the guide is "automatically" directed by the guide device in the direction of the passage opening of the medical treatment device The diameters of the guide device, the guide device and the through-opening in the medical treatment device can be suitably adapted to each other here Preferably, the minimum diameter of the guide device is equal to or slightly smaller than the adjacent part of the through opening of the medical treatment device the guide device is meaningful way slightly larger than the diameter of the guide, so that the guide without major mechanical resistance and can be introduced into the feeder without major play. By means of the connection device between the guide device and the medical treatment device, it can be ensured that the guide device is fed in the correct position to the through-opening of the medical treatment device. The connecting device can be designed in any way, for example by positive, non-positive or cohesive connection. A combination of several connection options is conceivable. In the context of this application, a medical treatment device can of course also be understood to mean a diagnostic device or an examination device (for example a camera catheter or an endoscope-like instrument).

Advantageous it is, if the connecting device at least one receiving device, which the medical treatment device at least partially can accommodate, and / or at least one positioning device for positioning the medical treatment device has and in particular one to the outer shape the medical treatment device corresponding contouring having. By such a receiving device or positioning device can the correct position supply of the guide in the passage opening of the medical treatment device particularly easy to be realized. In addition, can in such an embodiment, the feeder as protection for the medical treatment device (such as a PTCA balloon or a metal stent) serve. The corresponding part of the feeder can then namely, for example, the rather sensitive balloon or Cover the stent. It is conceivable, moreover, in addition or, where appropriate, regardless of the provision of a Recording device a protective device for the medical Provide treatment device. This could for example be designed as a thin wall. As a recording device or as a positioning offer itself next to a too outer surface the medical treatment device corresponding trained Inner surface of a receiving recess also, for example individual webs on, leaving the medical treatment device only in sections with the receiving device or the positioning device in contact. A possible (mechanical) holder the medical treatment device in the receiving device or positioning device can in any way by adhesion, Positive fit or material bond done, including combinations possible are. An (additional) cohesive Connection between between guide device, positioning or between receiving device and medical treatment device is preferably carried out in sections and / or using Predetermined breaking points.

The Feeding device can be carried out in such a way that the guide device funnel-like, in particular tapered, preferably conically tapered is trained. This can be a particularly simple and secure Feeding the guide into a through hole the medical treatment device are enabled. In particular, this can be a guiding effect in essence all directions are possible. For however, the feeder may well be sufficient be when a leadership effect is not in all directions, or only in one, two, three or more individual directions. For example, a kind of leading edge or two (or several) just trained bevels, which are at an angle to each other have, possible. Also a single flat surface with a guide groove (which preferably "two-dimensional funnel-shaped" is formed) is conceivable. Also it is possible to have one Type funnel to use, however, on one side of a recess having. Such not completely self-contained Leadership facilities have the advantage of being, for example can insert a guidewire "laterally", or can be taken laterally from the feeding device.

One particularly simple and inexpensive construction results, if the feeder in one piece, in particular in one piece is trained. So it would be possible, the feeder For example, in a single step in the injection molding process (possibly also Multicomponent injection molding process). A production from a single material can also have disposal benefits.

It However, depending on the specific application requirements also prove to be advantageous when the feeder at least made in two parts, preferably at least individual modules identical and / or symmetrical to each other are formed. This can be more complex, for example Geometries prove beneficial. If the assemblies each are identical, can also be used for manufacturing on a single Production plant (eg injection mold) for the identical ones Items are reclaimed. The items can be assembled in any way, for example by gluing, screws, clips, thermobonding or friction welding.

It may be advantageous if the feeder at least a hinge device and / or a film hinge device and / or a desired breaking point device and / or a locking device having. It is then possible to use the feeder quasi expand and possibly also close again, for example to a guiding device (eg a guidewire) or a medical device Treatment device (eg, a catheter balloon) in the delivery device insert or remove. This process is preferably multiple possible. It is also possible to use the feeder as a disposable item (as usual in the medical field anyway) execute and provided with predetermined breaking points. A repeated use of the feeder falls then immediately on.

Possible it is still, at the feeder at least an actuating device and / or at least one biasing means provided. Thus, a locking device (the z. B. realized by a clip-like engagement of the parts together is), for example, in addition to an actuator be provided so as to subsequently feed the feeder easy to reopen. A biasing agent can the opening movement of the feeder support.

meaningful it is the feeder with an integrated observer in particular for observation of a section of the guide device, in particular to the outside, and / or to observe a Area of the passage opening of the medical treatment device to provide. This can, for example, as a kind of magnifying glass (or a other optical imaging device) can be realized. This can the user when using the feeder supported again.

The proposed feeding device is particularly Advantageously, if it is the guide to a Catheter wire acts. Likewise, the proposed Use feeder particularly advantageous when it at the medical treatment facility around a cathederal balloon, a stent applicator, a catheter drilling device, a catheter milling device and / or is a laser beam release device.

Farther an assembly is proposed, which is a medical treatment facility and a feeding device according to the has the structure proposed above. Such a prefabricated Assembly is ideal for minimally invasive Interventions, such as PTCA intervention in particular use. The number The required handling steps can thus be further reduced and thereby the handling of the entire system can be facilitated become. Such a "pre-assembly" can at a corresponding In addition, the medical treatment device (such as for example, a balloon or stent). It is however, also conceivable, the feeding device also as a single component for free use available to provide, since even with the help of such a single component of the "threading process" can be made much easier.

As well a method is proposed in which a feeding device is used to guide a guide into a through hole at least one medical treatment device. Also in the context of the procedure, the above Proposals will be implemented accordingly. It turns out then the advantages already mentioned in an analogous way.

The Invention will be described below with reference to exemplary embodiments and with reference to the attached drawings explained. It shows:

1 a first embodiment of a feeding device in a schematic view seen from the side;

2 : in the 1 shown feeding device in a schematic view from above;

3 : in the 1 shown feeding device in a schematic view from the front;

4 a second embodiment of a feeding device in a schematic view seen from the front;

5 : in the 4 shown supply device in a schematic cross section from above;

6 a third embodiment of a feeding device in schematic cross section seen from the front;

7 a fourth embodiment of a feeding device in a schematic view seen from the side;

8th : A fifth embodiment of a feeding device in a schematic view seen from the front.

In 1 is a possible design for a threader 1 for balloon catheter 2 shown. At the balloon catheter 2 it is a balloon catheter 2 for percutaneous transluminal coronary angioplasty (PTCA - vascular dilatation by inflating a dilatation catheter). The per se known dilatation catheter 2 has an oval-like body 3 on. Longitudinal around the main body 3 Around is the actual Dilatationsballon in the manner of a cuff 4 arranged. In 1 on the right side is the connection hose 5 over which the dilatation balloon 4 can be acted upon with compressed air. In the middle of the main body 3 of the balloon catheter 2 , as well as in the middle of the connecting hose 5 runs a thin longitudinal opening 6 through which a guidewire 7 can be passed. The guidewire 7 is first brought via a separate catheter over an artery of the patient to the point to be treated in the body of the patient. After the guidewire 7 in turn, it serves as a guide to the balloon catheter 2 to lead to the point to be treated.

To the balloon catheter 2 To be able to lead to the point to be treated in the body of the patient, it is necessary, the coming of the patient end of the guide wire 7 in the longitudinal opening 6 the balloon catheter 2 threading. Because both the guidewire 7 , as well as the diameter of the Längsöff voltage 6 of the balloon catheter 2 are very small, the usual manual threading is difficult and time consuming.

To thread it's guidewire 7 in the longitudinal opening 6 of the balloon catheter 2 To simplify, first, the balloon catheter 2 with his front end 8th , which is located on the connecting tube 5 located in a balloon receiving opening 9 the threader 1 plugged. The dimensions of the balloon catheter 2 and the balloon receiving opening 9 the threader 1 are so matched to each other that the balloon catheter 2 with a certain holding force in the balloon receiving opening 9 gets stuck. In this position, the connection channel 10 the threader 1 and the longitudinal opening 6 of the balloon catheter 2 aligned with each other. On the the balloon intake opening 9 opposite side of the threader 1 is a funnel recess 11 intended. When the guidewire coming from the patient 7 into the funnel recess 11 is guided into, so is the guidewire 7 by the taper of the funnel recess 11 automatically in the connection channel 10 and then in the longitudinal opening 6 of the balloon catheter 2 guided. Threading the guidewire 7 in longitudinal opening 6 of the balloon catheter 2 is thus easy, fast and uncomplicated. The length of the connection channel 10 is chosen so that canting the guidewire 7 at the transition from the connection channel 10 in the longitudinal opening 6 of the balloon catheter 2 is largely excluded. In addition, in the area of the connection channel 10 a magnifying glass 12 provided, with the threading process can be controlled.

The threader 1 For example, it may be injection molded in one piece from a clear plastic material. To the magnifying glass 12 visually highlighting it is possible in this case, roughen parts of the surface, so that they are no longer transparent.

It is also possible the threader 1 and the balloon catheter 2 as a one-piece threader / balloon catheter system. Instead of a balloon catheter 2 Of course, other medical treatment, diagnostic or examination devices can be used. By way of example, it could be a stent applicator, a catheter bore device, a catheter milling device and / or a laser beam release device.

In 2 is the in 1 illustrated threader 1 seen from the front and in 3 shown from above. As you can see, the threader points 1 on one side a longitudinal slot 13 on top of the funnel recess 11 , the connecting channel 10 and the balloon receiving opening 9 to the side with the outside of the threader 1 combines. Once the balloon catheter 2 namely on the guidewire 7 Threaded, the threader must 1 from the guidewire 7 be removed. Thanks to the longitudinal slot 13 may be the guidewire 7 now be taken out laterally, without the threader 1 to have to destroy.

In the 4 and 5 is another threader 14 illustrated, which is another possible concept for removing the guidewire 7 served. Here is the threader 14 over a longitudinal section 15 in two halves 16 . 17 divided. The longitudinal section 15 but does not run through the entire threader 14 therethrough. Rather, a thin connecting web remains 20 between the two halves 16 . 17 , At the halves 16 . 17 is at a the connecting bridge 20 opposite side in each case a handle element 18 . 19 intended. Will the threader 14 on the handle elements 18 . 19 gripped and these are moved apart in the direction of arrow A, so acts the connecting web 20 as a predetermined breaking point. The two halves 16 . 17 the threader 14 can then individually from the guidewire 7 be removed.

In 8th is another "disposable" threader 38 shown schematically from the front. Notwithstanding that in the 4 and 5 illustrated threader 14 becomes the present threader 38 not by a pulling movement A, but by pressing the two halves 34 . 35 the threader 38 divided in the direction of arrow B to each other. These are the two halves 34 . 35 the threader 38 through a longitudinal section 36 separated from each other, which at an angle of for example 45 ° to the top and bottom provided gripping surfaces 39 . 40 runs. Between the two halves 34 . 35 But there is still a connection, the two halves 34 . 35 holds together in the initial state. This can be done, for example, by connecting areas in which the longitudinal section 36 is not consistently designed to be realized. Even an adhesive or a friction welding process, which has been carried out to a small extent, is to think. In any case, the longitudinal section works 36 like a breaking point. Now become the two halves 34 . 35 at the grip surfaces 39 . 40 in the direction of arrow B pressed together, the two halves in the direction of arrow C are parallel to the longitudinal section 36 acted upon by a mutually oppositely acting force until the predetermined breaking point (s) breaks. Thereafter, there are two separate, no longer connected halves 34 . 35 before, so that the threaded balloon catheter can be removed. So that the balloon catheter is not damaged when breaking the predetermined breaking point, is a correspondingly shaped recess 37 in the two halves 34 . 35 the threader 38 intended.

When in 6 illustrated threader 21 are the two halves 22 . 23 the threader 21 about a hinge 24 movably connected. In addition, between the two halves 22 . 23 a spring element 25 provided that tries the two halves 22 . 23 to push apart. The spring element 25 can in a suitable receiving space, in the halves 22 . 23 is provided, are arranged.

One of the two halves 22 has a protruding latch 26 on, in an undercut recess 27 the other half 23 engages and there latched like a clip. The with the recess 27 provided half 23 also has an actuator 33 on, with which the catch nose 26 out of engagement with the recess 27 can be brought. Will the actuator 33 pressed down, so snap the two halves 22 . 23 due to the spring element 25 force apart and give the guidewire 7 free.

In 7 is finally yet another threader / balloon catheter combination system 28 shown. The balloon catheter 30 points to his before the end 31 a funnel sleeve 29 on, as a threading aid for a guidewire 7 serves. The funnel sleeve 29 has in the axial direction (longitudinal direction) a plurality of predetermined breaking points or cuts, so that the funnel sleeve 29 is structured in individual radial sectors. Each of the radial sectors is at at least one connection point 32 with the balloon catheter 30 connected. For example, it is a cohesive connection. The connection points 32 are designed so that they serve as a predetermined breaking point. So is the guidewire 7 in the longitudinal opening 6 of the balloon catheter 30 threaded, so the surgeon can use the individual sectors of the funnel sleeve 29 abort. Then he can use the remaining balloon catheter 30 along the guidewire 7 into the patient. Of course, other medical treatment, diagnostic and examination devices are also conceivable here.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 3326648 A1 [0005]
• - DE 2119172 A [0005]
• - DE 69629167 T2 [0005]
• - DE 102005007585 A1 [0006]

Claims (11)

Feeding device ( 1 . 14 . 21 . 28 . 38 ) for supplying a guide ( 7 ) in a passage opening ( 6 ) at least one medical treatment device ( 2 . 30 ), comprising a management device ( 11 . 29 ), which the guiding device ( 7 ) when feeding them into the feeding device ( 1 . 14 . 21 . 28 ) and a connection device ( 9 . 32 . 37 ), which the medical treatment device ( 2 . 30 ) at least partially with the management facility ( 11 . 29 ) connects. Feeding device according to claim 1, characterized in that the connecting device at least one receiving device ( 9 . 37 ), which the medical treatment device ( 2 . 30 ) at least partially and / or at least one positioning device for positional positioning of the medical treatment device ( 2 . 30 ), in particular a corresponding to the outer shape of the medical treatment device contouring. Feeding device according to one of the preceding claims, characterized in that the guide device ( 11 . 29 ) funnel-like, in particular tapering, preferably is conically tapered. Feeding device according to one of the preceding claims, characterized in that the feeding device ( 1 . 14 . 28 . 38 ) is integrally formed, in particular in one piece. Feeding device according to one of the preceding claims, characterized in that the feeding device ( 21 ) at least in two parts ( 22 . 23 ), wherein preferably at least individual assemblies are identical and / or symmetrical to each other. Feeding device according to one of the preceding claims, characterized in that the feeding device ( 14 . 21 ) at least one hinge device ( 24 ) and / or a film hinge device and / or a predetermined breaking point device ( 20 . 36 ) and / or a locking device ( 26 . 27 ) having. Feeding device according to one of the preceding claims, characterized by at least one actuating device ( 18 . 19 . 33 . 39 . 40 ) and / or at least one biasing means ( 25 ). Feeding device according to one of the preceding claims, characterized by an integrated observation device ( 12 ), in particular to observe an area ( 10 ) of the guidance device ( 11 ), in particular to the outside, and / or a region of the passage opening ( 6 ) of the medical treatment device ( 2 ). Feeding device according to one of the preceding claims, characterized in that it is in the guide ( 7 ) is a catheter wire. Feeding device according to one of the preceding claims, characterized in that it is in the medical treatment device ( 2 . 30 ) is a catheter balloon, a stent applicator, a catheter bore device, a catheter milling device, and / or a laser beam delivery device. Assembly comprising a medical treatment device ( 2 . 30 ) and a delivery device ( 1 . 14 . 21 . 28 . 38 ) according to one of the preceding claims.