WO1983001894A1

WO1983001894A1 - Device for eliminating or expanding strictures in vessels conducting body liquids

Info

Publication number: WO1983001894A1
Application number: PCT/CH1982/000122
Authority: WO
Inventors: Medintag Ag Schneider
Original assignee: Weikl, Andreas; Merkel, Volkmar
Priority date: 1981-11-24
Filing date: 1982-11-23
Publication date: 1983-06-09
Also published as: DE3275056D1; MX156228A; DE3235974A1; ES8307511A1; AU562306B2; FI832323A0; FI82804C; FI832323L; JPS58501983A; CA1204644A; ES517777A0; FI82804B; DK337283A; DK337283D0; NO166165C; EP0080436A1; ATE24828T1; BR8207993A; EP0080436B1; NO166165B

Abstract

The device is intended to reduce or eliminate strictures in vessel of any kind, to treat the breaches and the tearings in the walls of the vessels, the stenosis in blood vessels and to avert the danger of infarct. It comprises a catheter (1) provided with two expandable balloons (4, 5) which block a stricture (6) of a vessel on both sides. The rate of expansion of the two balloons (4, 5) is adjustable from the outside. An inlet part (A) for supplying a product capable of dissolving or decomposing into small particles the narrowing material (7) and an outlet part (B) for evacuating the dissolved or decomposed material of the stricture of narrowing are provided in the wall of the catheter (1), in the portion limited by the two balloons (4, 5). These two inlet and outlet parts are each connected to a channel (10, 11) accessible from the outside.

Description

Device for removal or

Widening of constrictions in vessels that carry body fluids

The invention relates to a device for removing or widening constrictions in body fluid-carrying vessels according to the preamble of claim 1.

In a device of this type known from DE-AS 10 69823, at least two expandable balloons are provided one behind the other at the end of a treatment catheter on the vessel side. Each balloon is connected to an externally accessible channel and can be inflated individually by external pressure. After the treatment catheter has been inserted into a ureter, the ureter can be expanded by inflating the balloons. A stone which can be closed or forms a constriction can be enclosed between the balloons. In the expanded state of the balloons, the treatment catheter is pulled out of the ureter and the stone is removed. However, complications can arise if, for example, the stone gets stuck between a balloon and the ureter wall when it is pulled out. By changing the extent of the

Balloons must then be correctly gripped again in the area delimited by the balloons. When pulling out, the entire ureter is subjected to a strong stretch from the narrow point, and the inner wall is particularly stressed by strong frictional pressure. Cracks and detachments can therefore occur at least on the inner wall of the ureter.

Furthermore, it is also known from DE-OS 30 28089 to expand constrictions in the arterial system to use a treatment catheter, at the end of which a balloon which is definitely expandable in its circumference is attached. This balloon is placed in the area of the constriction and filled with liquid via a catheter so that the tissue causing the constriction is pressed into the wall of the blood vessel nine and remains there. In many cases, it cannot be avoided that during the

Dilatation leads to tearing of the intima - the innermost wall of the vascular system. There is also the risk that the inner layers of the vessel are partially detached and occupy the free interior of the blood vessel, as a result of which occlusions and / or reduced blood flow to the organs that are supplied by the affected blood vessel can arise in the vascular system. For example, an infarction can occur on the coronary arteries due to insufficient blood supply. The object on which the present invention is based is to provide a device which is simple in construction, can be produced economically and is reliable, with the aid of which the constrictions of any body fluid-carrying vessels, regardless of their spatial arrangement or extent in the vascular system, are reduced or eliminated in such a way that none Dips or cracks in the wall of the vessel can occur. When the device iii blood vessels according to the invention is used, the supply of the organs or the organs downstream of the constriction should also be ensured during a long-lasting constriction treatment and thus a risk of an infarct should also be excluded in such cases.

This object is achieved by the characterizing features of claim 1.

By arranging an opening between the two balloons and connecting them to a channel that is accessible from the outside, each point can be gently removed in a relatively short time by deliberately dissolving or crushing bottleneck material and one or more subsequent flushing operations. Here there is practically no adverse side effect due to vascularization, since this in ge healthy area of the vessel and only in two narrow places. The device according to the invention can therefore be used in all those cases in which the constriction is formed by dissolvable and / or crushable substances.

Due to the softening of the constriction material, the removal thereof from the region of the constriction is particularly unproblematic, since there is a risk of damage to the vessel walls in it. Fall on

Because of the consistency of the bottleneck material is completely excluded.

According to an advantageous embodiment of the invention, a supply channel can additionally be provided, through which an adequate supply of the downstream organ can be ensured at the same time during the bottleneck treatment. It is particularly advantageous that with the invention, within a definable range of vessels carrying fluid, treatment fluids, possibly also in a more concentrated form, can be brought into effect on the bottleneck material over largely arbitrary periods of time.

Advantageous embodiments of the invention are the subject of the dependent claims.

The invention is explained in more detail below on the basis of exemplary embodiments which are shown in the drawing on a greatly enlarged scale. Show it:

Figure 1 In longitudinal section, a blood vessel, each with an inserted

Guiding and treatment catheter, as well as with the blocking balloons arranged on both sides of the constriction,

Figure 2 shows a cross section according to the

Section line II-II of Figure 1,

FIG. 3 shows a longitudinal section of the treatment catheter with a balloon arranged to be displaceable thereon,

Figure 4 shows a cross section according to the

Section line IV-IV of Figure 3,

5 shows a view of a treatment catheter with retracted partitions to form channels for the supply and discharge of liquids or gases,

6 shows a longitudinal section of a treatment catheter part with partially perforated lateral surfaces or predetermined breaking points, according to section line VI-VI of FIG. 5,

FIG. 7 shows a longitudinal section through a vessel section with an inserted treatment and guide catheter and with a channel in the treatment catheter that serves to supply and at the same time to supply the balloon pressure,

8 shows a cross section along the line VIII-VIII of FIG. 7,

FIG. 9 shows a longitudinal section through a vascular section with an inserted treatment catheter and a region-limiting catheter that can be displaced on it,

Figure 10 shows a cross section along the section line X-X of Figure 9 and

11 shows a cross section corresponding to a section line X-X of FIG. 9, but with a treatment catheter with only one longitudinal dividing wall, as shown in FIGS. 7 and 8.

The treatment catheter 1 is inserted into a blood vessel 3 through a guide catheter 2. It projects beyond the guide catheter 2 to such an extent that the balloons 4 and 5 arranged on the treatment catheter 1 with the constriction 6 or stenosis enclosed between them before the end of the guide catheter 2. The constriction 6 is usually formed from a sponge-like, lime and fat-rich fabric 7, which is indicated in the drawing with cross hatching. In the event that the tissue 7 closes the passage of the blood vessel 3 completely or almost completely, the treatment catheter 1 or another instrument is pushed through it. Otherwise, the treatment catheter 1 is passed so far through the still existing opening of the constriction 6 that the balloon 4 in the inflated state 4 'seals the constriction 6 on the back and the balloon 5 in the inflated state 5' seals the constriction 6 on the front side, ie that the blood vessel 3 on both sides of the constriction 6 is tightly sealed all around.

The balloons 4, 5 can be expanded or inflated by gas or a liquid medium. The latter can be let in or out through the inlet / outlet nozzle 8 or 9 and via a pressure channel 10, the amount and pressure of which can be regulated. Thus, in the treatment of constrictions 6 in blood vessels, in spite of the bilateral occlusions of the constriction 6, the supply of the downstream organs or organs, particularly in the case of longer ones Intervention times is ensured, an additional supply channel 11 is provided, which represents a kind of "bypass line" to the sealed constriction area. This supply channel 11 is preferably arranged coaxially with the treatment catheter 1. However, deviating from this, it can also be installed or attached in a different position and / or in the form of a larger number of channels. Via this supply channel 11, blood and / or another liquid, preferably with excess pressure, can flow in from the outside or with the help of an overflow channel from the bloodstream before the blockage. As a result, sufficiently long intervention times are available without there being a risk of an infarction.

So that only the lime and fat-rich tissue 7 of the constriction 6, but not the inner skins of the blood vessel 3 are attacked, a chemical agent in the form of a solution is pumped into the space containing the constriction tissue 7 through the inlet channel 12 with the inlet piece A. able to dissolve tissue 7. For this, among other things, Digestive enzymes or similar substances.

For other applications, such as the treatment of biliary or kidney stones, other substances such as dissolving acids can also be used. For the removal of the dissolved or comminuted particles and for shortening the treatment time, a continuous circulating rinse is advantageous, which is ensured via a return channel 13 with the outlet piece B. In principle, however, it is also possible to supply the agent which dissolves the throat material 7 or divides it into smaller particles via a single channel and alternately discharges the loosened or crushed throat material 7 via the same channel. Such an embodiment is shown in FIGS. 7, 8 and 11, which will be explained in more detail later. Of course, the inlet channel 12 can also be used as a return channel and the return channel 13 as an inlet channel.

The number of inlet and return channels can also be increased as required.

In order to be able to adapt the size of the blockage point to the expansion of the tissue 7, it is advantageous if the balloon 5 is not arranged rigidly - as indicated in FIG. 1, but rather is displaceably arranged on the treatment catheter 1. Such an embodiment is shown in FIGS. 3 and 4. The balloon 5 is attached to a slider 14, preferably with the aid of a stiffer synthetic fiber, preferably Perlond 15 15 or the like. can be moved back and forth from the outside. The synthetic fiber wire 15 can

are guided in a channel 16 which, for example, is introduced in a longitudinal reinforcement 17 of the treatment catheter 1, which is used for guiding the slide 14 at the same time, that is to say practically in its wall reinforcement. Through this channel 16, the inflation medium can be supplied and discharged and its pressure can be regulated from the outside.

So that the gap between the slide 14 and the outer wall of the treatment catheter 1 is properly sealed, a sealing sleeve 18 is provided at least on the side facing the constriction 6, which additionally contributes to the effective sealing at this sealing point by the special shape of the balloon 5. With 19 the nozzle is designated, via which the gaseous or liquid medium for expanding the now displaceable balloon 5 is supplied or discharged.

Instead of the tubular channels 10, 12, 13 which are supplied and fastened to the wall parts of the treatment catheter 1, the interior of the treatment catheter 1 can also be divided accordingly by longitudinal dividing walls 20 (FIGS. 2 and 5), so that chambers 21 are formed, through which, as required , the appropriate medium can be directed. Furthermore, it can be advantageous in some cases - especially when using longitudinal partitions 20 - instead of attaching inlet / outlet nozzles 8 and 9 or nozzles A and B at the ends of channels 12 and 13, at these points the wall of the To provide treatment catheters 1 with perforations 23, which, as can be seen from FIGS. 5 and 6, only arise after breaking open predetermined breaking points '22, so that the length of the perforated catheter part is adjusted only before the intervention according to the size of the narrowed area to be treated can.

FIGS. 7 and 8 show a further exemplary embodiment according to the invention with a single longitudinal dividing wall 20. As a result, the treatment catheter 1 is divided into two channels, one of which is a combined one

Pressure and supply channel 24 and the other is designed as a combined inlet and outlet channel 25 for the constriction 6. One channel 24 has an opening 8 or 9 in the area of each balloon 4, 5 and on the vessel side

End 26 of treatment catheter 1 has an outlet opening 27. The other channel 25 has an inlet / outlet opening A / B in the limited area. In this treatment catheter 1, which is particularly suitable for small vascular cross-sections because of its possible smaller diameter is once achieved that the balloons 4, 5 can be expanded by a liquid pressure generated in the channel 24 by means of a liquid that can be supplied from the outside, in particular a supply liquid for organs downstream, for example blood, and thereby the limited area around the constriction 6 is sealed on both sides. The liquid then exits under pressure through the outlet opening 27. On the other hand, a substance or the like which dissolves the throat material or the like can be pumped through the other channel 25 continuously or alternately into the throat 6 and subsequently dissolved throat material with the rest

Substance are sucked off. In this way, the desired effect is made possible with a treatment catheter 1 that is easy to manufacture, the cross-section of which can be kept very small.

According to a further advantageous development of the invention, in this embodiment the one balloon 4 or 5 can have a more elastic envelope or wall than the other. In the embodiment according to FIGS. 7 and 8, this is the balloon 4. This makes it possible to adjust and regulate the pressure in such a way that both balloons 4 and 5 seal and, for example, when the substances are withdrawn from the limited area of the Balloon 4 still seals, but balloon 5 no longer (see FIG. 7). This makes it possible to use the guide catheter 2 in addition for flushing or suction, since with such a pressure setting the constriction 6 is also accessible from the side of the guide catheter 2.

Expediently, the balloons 4, 5 of the device according to the invention can be designed such that they assume a certain shape and size and then no longer become larger even when using a considerably higher pressure.

9, 10 and 11 of the advantageous refinements of the subject matter of the invention, the balloon 5 further away from the vessel-side end 26 of the treatment catheter 1 is provided on or on the end of a region-limiting catheter 28 which is arranged displaceably on the treatment catheter 1. The area limiting catheter 28 is provided with a pressure channel 29, which is preferably integrated into the wall of the area limiting catheter 28. Is and which opens into an opening 30 provided within the balloon 5. By shifting the area delimitation catheter 28, the length of the delimited area can be selected according to the needs and can be sealed or opened by the separate expansion possibility of the balloon 5. Here, too, there can advantageously be a space between the treatment Leave catheter 1 and the limiting catheter 28 and this can be used for flushing or suction. For a very compact construction, one or more notches 31 can also be provided on the inner wall of the area-limiting catheter 28 and / or notches 32 on the outer wall of the treatment catheter 1, as shown in FIGS. 10 and 11. In order to achieve larger cross sections for the flow, the notches 31 of the area-limiting catheter 28 can be arranged opposite the notches 32 of the treatment catheter 1. In this constructive solution too, as shown in FIG. 11, a single longitudinal partition 20 can be provided in the treatment catheter 1 and the treatment catheter 1 can have openings, as described with reference to FIG. 7, so that the advantageous effects described there can also be achieved. The devices according to FIGS. 9, 10 and 11 can also have a guide catheter 2 (not shown).

The catheter according to the invention for the treatment of constrictions can be used in all types of vessels carrying body fluids, that is to say in all types of blood vessels or other vessels carrying liquids, such as CSF channels or also in larger lymphatic vessels. Further areas of application - in addition to the main area of application for the treatment of constriction in blood vessels - are, for example, the treatment of constrictions in the bile duct, in the pancreatic duct or in the spinal canal.

With the invention, it is also possible to bring chemical substances in highly or more concentrated form to vessel areas with the aim of stimulating capillary sprouts from these vessel areas. In particular, those of Dr. Josef Wissler, Max Planck Institute, Bad Nauheim described substances for stimulating vascular sprouts, namely angiotropins, which are isolated from white blood cells.

The bottleneck treatment with the catheter according to the invention can be carried out in several stages, optionally using different treatment media and / or different concentrations of the treatment media.

Claims

Patent claims

1. Device for removing or widening constrictions in vessels carrying body fluids using a flexible treatment catheter, at the end of the vessel on the vessel side of which two balloons which can be expanded by an externally adjustable pressure are provided in such a distance that the one in front and the other behind the Constriction can be placed and the constriction can be sealed in both ways by the expansion of the balloons, characterized in that in the area delimited by the two balloons (4, 5) in the wall of the treatment catheter (1) at least one opening (A, B; A / B ; 23) is provided, which forms or form the mouth of at least one inlet and / or outlet channel (12, 13; 25) which is accessible from the outside, in such a way that through this or these inlet and / or outlet channels (12, 13 ; 25) from the outside means In the limited area, in particular a material that dissolves the throat material (7), divides into smaller particles and / or softens al, introduced and / or substance, insbe

special loosened or split throat material (7) from which limited area can be removed to the outside.

2. Apparatus according to claim 1, characterized in that at least one supply channel (11, 24) is additionally provided, which on the one hand at the end (26) of the treatment catheter (1) on the side of the vessel, ie after the two balloons (4, 5) into the vessel (3) opens and on the other side is either accessible from the outside or opens into the vessel (3) in front of the limited area (balloon 5) in such a way that substances can be transported through the limited area during the constriction treatment.

3. Device according to claim 1 or 2, characterized in that each balloon (4, 5) with at least one externally accessible pressure channel (10, 29) is connected so that the degree of expansion of each balloon (4,5) independently is adjustable.

4. Apparatus according to claim 1 or 2, characterized in that both balloons (4,5) are connected to a common pressure channel (10, 24).

5. The device according to claim 4, characterized in that the common pressure channel (24) is also the supply channel.

6. The device according to claim 4, characterized in that the balloons (4,5) have different elasticity such that with increasing pressure only one (4 or 5) and at higher pressure also the other balloon (5 or 4) the blocking Expansion has been reached and when the pressure decreases, one (4 or 5) still blocks and the other (5 or 4) assumes a position that is no longer blocking.

7. Device according to one of claims 1 to 6, characterized in that the balloons (4,5) are designed such that they can only perform a limited, but sufficient to shut off expansion.

8. Device according to one of claims 1 to 7, characterized in that the supply channel (11) is arranged coaxially to the treatment catheter (1).

9. Device according to one of claims 1 to 8, characterized in that all channels (10, 11, 12, 13, 24, 25) are formed by at least one longitudinal partition (20) provided in the treatment catheter (1).

10. Device according to one of claims 1 to 9, characterized in that all or at least some channels (10, 11, 12, 13, 24, 25) are formed in or on the treatment catheter (1) before seen tubes.

11. Device according to one of claims 1 to 10, characterized in that the inlet and outlet pieces (A, B) for the treatment medium are formed by perforations (23) introduced into the wall of the treatment catheter (1) and that the treatment catheter (1 ) is divided into one or more longitudinal partitions (20) into chambers (21).

12. The device according to one of claims 1 to 11, characterized in that as a solution or. Rinsing agents for dissolving or eliminating the throat tissue (7), digestive ferments or substances having a similar effect can be fed to the inlet and outlet pieces (A, B).

13. The device according to one of claims 1 to 12, characterized in that the constriction (6) on the input side closing balloon (5) on the outer wall of the treatment catheter (1) is arranged displaceably.

14. The apparatus according to claim 13, characterized in that a slide (14) is used as the displacement means for the movable balloon (5), which can be moved back and forth from the outside.

15. The apparatus according to claim 13 or 14, characterized in that the slide (14) on the jacket of the treatment catheter (1) is guided.

16. Device according to one of claims 13 to 15, characterized in that the slide (14) serves as a carrier of the hose (16) for the transmission of the pressure medium for the balloon (5) connected to it or is itself designed as such.

17. The device according to one of claims 13 to 16, characterized in that the slide (14) at least on the side of the constriction (6) facing a sealing sleeve (18) which is from a pressure medium, in particular from the inflated balloon (5 ' ), firmly pressed onto the outer surface of the treatment catheter (1).

18. Device according to one of claims 13 to 17, characterized in that the slide is designed as a region-limiting catheter (28) enclosing the treatment catheter (1).

19. The apparatus according to claim 18, characterized in that in the area limiting catheter (28) an outwardly leading channel (29) is integrated or this is provided with a hose.

20. The apparatus according to claim 18 or 19, characterized in that the inlet and / or outlet channel (25), optionally also other channels, by at least one notch (31, 32) in the inner wall of the area delimiting catheter (28) and / or is or are formed in the outer wall of the treatment catheter (1).

21. The apparatus according to claim 20, characterized in that the notch (s) (32) of the treatment catheter (1) relative to the or the notch (s) (31) of the area limiting catheter (28) is provided.

22. The apparatus according to claim 2o or 21, characterized in that the treatment catheter (1) through a longitudinal partition (20)

Is divided into a pressure channel (10) for the one balloon (4) and a supply channel (11) and that the notches (31, 32) serve as inflow and / or outflow channels for the limited area.

Method for removing or widening constrictions, preferably stenoses, in vessels carrying body fluids, such as arteries, veins or the like, using a flexible treatment catheter, on the end of which the vessel is arranged, two balloons are arranged, characterized in that with the two balloons a constriction, preferably stenosis-containing section of the vessel is sealed in such a way that the circulation of the body fluid contained in the vessel to the successor organs is maintained, that a solvent of a predetermined concentration and duration of action is brought into effect on the constriction, preferably stenosis, such that the constriction, preferably stenosis, dissolved, softened or broken up into smaller particles, and that the narrowed material thus dissolved, softened or broken down into smaller particles is removed from the sealed section of the vessel.

A method according to claim 23, characterized in that the dissolved bottleneck material is discharged through the or one of the supply channels of the treatment catheter. A method according to claim 23, characterized in that the pressure of the two balloons is controlled individually or together.

Method according to claim 25, characterized in that in the case of a single balloon pressure control, a different pressure is set in the two balloons in the sense that a lower pressure in the balloon (5) in front of the constriction (7) than in the balloon (4 ) is set after the constriction (7).

A method according to claim 23, characterized in that the type, concentration and duration of the solvent is applied to the throat material in such a way that the throat material is only softened, so that it is withdrawn from the vessel when the treatment catheter is withdrawn, possibly at reduced pressure of the one or both balloons through which the treatment catheter is removed as a whole.

A method according to claim 23, characterized in that the solvent on the bottleneck material according to type, concentration and duration Is brought effect that the constriction material is broken up into smaller particles and is discharged through the or one of the supply channels of the treatment catheter.

A method according to claim 23, characterized in that the solvent used is ferment, preferably digestive ferment, acid or alkali.

A method according to claim 29, characterized in that a nitrous acid is used as the acid. A method according to claim 29, characterized in that a sodium hydroxide solution is used as the alkali.

A method according to claim 23, characterized in that the duration of action of the solvent on the throat material is limited to a predetermined period of time by inhibitors such as ferment blockers, neutralizing acids or alkalis.

Method according to claim 23, characterized in that a circulating flush is used for the removal of the loosened, softened or narrowed material divided into smaller particles. A method according to claim 23, characterized in that the double balloon catheter is used for performing the circulating flush.