WO2007068318A1

WO2007068318A1 - Balloon catheter device

Info

Publication number: WO2007068318A1
Application number: PCT/EP2006/010931
Authority: WO
Inventors: Thomas Schmitz-Rode
Original assignee: Rheinisch-Westfälische Technische Hochschule Aachen
Priority date: 2005-12-14
Filing date: 2006-11-15
Publication date: 2007-06-21
Also published as: DE102005060197A1

Abstract

The invention relates to a balloon catheter device with an inflatable and deflatable balloon which can be introduced into a blood vessel and which is arranged in particular at or in the area of a catheter end, and with an actuating device for actuating the balloon, the balloon catheter arrangement (1) being implantable in its entirety in the body of a living being, and the actuating device (8) located in the body being able to be actuated from outside the body. The invention further relates to a catheter device with a catheter end that can be introduced into a blood vessel, in particular a balloon catheter device comprising a container which can be punctured by a hollow needle from outside the body and whose volume is in fluidic communication with a catheter end insertable into a blood vessel, in particular wherein the fluidic communication is effected through a channel arranged in a catheter shaft.

Description

Balloon catheter device

The invention relates to a balloon catheter device with an inflatable and deflatable balloon which can be inserted into a blood vessel, in particular which is arranged on or in the region of a catheter end and with an actuating device for actuating the balloon. The invention further relates to a non-balloon catheter device having a catheter end insertable into a blood vessel.

Balloon catheter devices of this type are known in the prior art and serve, for example, after insertion into a blood vessel to dilate this blood vessel or to occlude it at least temporarily by the inflation of the balloon. Such a catheter is known, for example, as a pulmonary catheter or as a Swan-Ganz catheter, which is known e.g. is used in connection with the measurement of the hemodynamics of a living being, such as an animal or a human. Thus, with such catheters, accurate measurements, e.g. the filling pressure of the right atrium and right ventricle, the pulmonary artery pressure and pulmonary occlusion pressure, the cardiac ejection performance, the venous, mixed venous and pulmonary arterial oxygen saturation of the blood possible.

It is particularly disadvantageous in the case of such balloon catheters that an actuating device for actuating the balloon, which can be arranged, for example, on or in the region of the catheter end, is arranged outside the body of a living being to be examined and thus always a body passage when examined by means of a balloon catheter must be done through the skin of a living thing, causing complications eg by the entrance of pathogens in the body of the animal. Thus, such balloon catheter devices are not suitable to be used for longer examination periods, so that multiple examinations also involve a multiple setting and subsequent removal of such a known balloon catheter device, resulting in a significant, always recurring load on the examined animal. Thus, with each examination at a puncture site for the passage of the skin of the catheter shaft of such a balloon catheter, there is always an infection source with the corresponding risks.

The object of the invention is to provide a balloon catheter device, by means of which the above-mentioned problems are overcome and thus multiple, even temporally larger-spaced measurements are possible, without requiring recurring intervention on the body of a living being to be examined and thus in particular longer-term studies, for example on many Hours, days, weeks or even months.

This object is achieved by a balloon catheter device of the type mentioned, which is inventively characterized in that the balloon catheter assembly can be implanted in its entirety in the body of a living organism and the actuator located in the body from outside of a body actuated.

It is thus an essential core idea of this invention that a balloon catheter device according to the invention is provided and set up to be completely implanted in the body of a living being in order to be able to remain there. Hereby, skin penetration sites for the implementation of the catheter shaft to the outside of the body are avoided, thereby excluding the risk of infection at such skin penetration sites. It comes with the help of the balloon catheter device according to the invention only to one or two interventions on the body of the living being, namely once to set the catheter and on the other to remove the catheter, if one Examination period, which may be hours, days, weeks or months, possibly longer may be completed. Therefore, with the balloon catheter according to the invention again and again, and in particular temporally spaced, measurements can be carried out without having to intervene again for each measurement in the body of a living being.

In this case, in a preferred embodiment of the balloon catheter device according to the invention, it may be provided that an actuator and a balloon are arranged at opposite ends of the balloon catheter device and are connected to each other by a catheter shaft, wherein it may be provided that the end of the balloon catheter device containing the balloon carries, is inserted into a blood vessel, whereas the other end, which has the actuating device, outside a blood vessel, eg in the surrounding tissue. Accordingly, a blood vessel, which is equipped with a balloon catheter according to the invention, a vessel wall puncture, which can be closed in a known manner. For this purpose, medical measures are available to the person skilled in the art, as disclosed in particular in a previously filed patent application of the same Applicant, no. DE 10 2005 035 795.4.

In this case, a balloon of such a balloon catheter device can either be arranged directly at the end of the catheter shaft, which is formed as a channel or at least comprises such a channel, or before the end of the shaft in the end region, for example, the channel in FIG Catheter shaft has approximately arranged in the radial direction bores (in particular at least one bore), which is covered by an elastic tube, so that from the channel interior of the catheter shaft through the holes, the elastic tube shell is inflatable and thus forms a balloon. In this case, in a particularly preferred embodiment, an inflation / deflation of the balloon can be generated by a fluid flowing back and forth between the balloon and the actuating device, in particular by a catheter shaft, this fluid being given for example by air or gas or a liquid, in particular of a sterile nature can be.

Particularly preferred here isotonic saline solution can be used, since this can not lead to a health hazard even in the unlikely event of leakage.

According to the invention, it may then be provided that, by actuating the actuating device, a flow of fluid is effected at least into the balloon. In this case, it may further be provided that a backflow of the fluid can also be effected automatically by an actuation of the actuating device or also automatically after an actuation, for example by means of a restoring force provided in the actuation device.

In a possible embodiment of the actuating device, it may be provided that it comprises a fluid pump, which may be e.g. manually or electrically and / or magnetically actuated. Thus, by switching on or triggering such a fluid pump provided from outside a body according to the invention, a flow of the fluid at least into the balloon, possibly also out of the balloon, can be effected, e.g. when the pumping direction of the fluid pump is reversible.

For example, a manually actuated fluid pump may be formed by an arrangement of a piston in a fluid-filled cylinder such that the manual displacement of the piston in the cylinder displaces the fluid therefrom and displaces it into the balloon. Such an actuation can take place, for example, by means of the hand of an examining physician through the skin of a patient, provided that the actuation device of a balloon catheter according to the invention is arranged in the area below the skin. It can do this be provided for an automatic return of the piston in the cylinder that, for example, a spring and a spring force caused by this spring acts between the piston and cylinder, which must be overcome during actuation and automatically after completion of the operation provides for a provision, so that the fluid automatically flows back out of the balloon.

Instead of a manual operation of such an arrangement of piston and cylinder, it may also be provided to use a drive whose operation displaces the piston in the cylinder.

Any type of fluid pump, and in particular the aforesaid piston and cylinder embodiment, as well as any other type of electrically powered actuator, may have a drive which receives its power to operate from outside the body, e.g. by an electromagnetic coupling / radiation. Such a drive may e.g. be formed by an electric motor and / or piezo motor, in particular having a receiver for the necessary operating energy.

In another embodiment provided structurally for its simplicity, the actuating device can be designed as a container, from which fluid can be displaced by an external force or pressurization. Thus, such a container fluidly connected via a channel in the catheter shaft with the balloon, so that by pressing on this container, for example, through the skin of a living being, the fluid can be displaced into the balloon. A container provided for this purpose may for example be designed such that it has at least one flexible and / or elastic and / or at least variable in its position container wall, so that from outside a body, a change in volume of the container can be effected by a force or pressurization. In a container with otherwise stable container walls, for example, a flexible membrane may be provided for this purpose. In another embodiment, it can also be provided that the actuating device comprises a fluid and / or gel which expands under the influence of heat, so that an actuation can also be effected by initiating an expansion of this fluid or gel from outside the body, for example in that energy is introduced into this fluid or gel and thus into the actuator. This can be done in any way, for example by heat radiation or by inductive energy coupling or other electromagnetic radiation of energy into the actuator from the outside. As a result of the expansion of the fluid or gel, at least part of it is displaced into the balloon, so that it is inflated and can close off a blood vessel. After completion of an operation, ie interruption of the energy input, the fluid and / or gel automatically contracts due to the heat loss to the environment again, so that the balloon collapses again.

In particular, in this aforementioned variant of an operation by the action of heat, it may also be provided that instead of an arrangement of the actuating device at the opposite end of the balloon catheter, the actuating device is arranged directly in the balloon. For example, the balloon itself may form the actuator, e.g. when the balloon defines a closed volume that is filled with a heat-expanding substance, such as a fluid or gel.

Then it can expand and contract, as described above, when a heat input takes place or is interrupted again.

In particular, when using such heatable and under heating expanding fluids or gels, it may be provided that they additionally comprise substances that absorb the energy entered from outside particularly well, which is the case for example when it comes to inductively heatable substances or particles , such as iron oxide nanoparticles. In all conceivable within the scope of the invention and in particular in the aforementioned embodiments, it can be provided that a balloon catheter device according to the invention additionally comprises a device for monitoring and / or limiting a maximum balloon expansion and / or a maximum pressure in the balloon, in particular to a blood vessel damage prevent. Thus, it may be provided, for example, that such a device monitors the pressure in the balloon and automatically interrupts the actuation of the actuator when exceeding a predetermined or at least predetermined maximum pressure and / or capacity, which is particularly possible in a simple manner, if are electrically operated actuators.

In addition to being able to provide internal body actuators of a balloon catheter device according to the invention, e.g. It may also be intended to operate externally by other physical effects, such as electrical, magnetic, electromagnetic, or other conceivable external body influence on the internal actuator, by manual manipulation of the hand of a treating physician.

For this purpose, it can be provided, in particular, that a body-internal actuating device is associated with a body-external actuating device with which it can be provided, in particular, to be able to perform an intermittent actuation / activation / release of the body-internal actuating device.

Thus, in this manner, for example, a patient who needs to undergo a long-term study may wear an external actuator that activates or triggers by a physical coupling, such as the type described above, the internal actuator. This can in particular be controlled by a program in any predeterminable manner. According to the invention, it can be provided in a particularly preferred embodiment that the balloon catheter device additionally comprises a sensor, for example at the catheter end or in the region of a catheter end insertable into a blood vessel, by at least one physiological measurable variable such as blood pressure, temperature, oxygen saturation or similar, to capture. Such a sensor can then be connected inside the balloon catheter device according to the invention, for example by an electrical lead through a catheter shaft, to a transponder unit, by means of which a wireless transmission of this at least one measured variable to an external reading station is possible. Preferably, the transponder unit is structurally integrated with the body-internal actuator for the balloon.

For this example, the known RFID technology can be used. Such a body-external reading station can be arranged, for example, within an above-described body-external actuating device, so that these two form a common arrangement. It can then be controlled or activated by an external actuator, for example, by a predetermined program sequence of a control unit, the body-internal actuator of the balloon catheter according to the invention to achieve inflation of the balloon, after which the closure of a blood vessel caused thereby a desired measurement, z , As the so-called closure pressure in the pulmonary arteries, detected by the arranged in the catheter tip sensor and transmitted to the outside of the body in the external actuator and stored there, for example. Thereafter, deflation of the balloon may be effected by the external actuator to release the blood vessel occlusion and re-establish blood circulation. It may then further be provided that stored measured values are read out of the external actuating device in order, for example, to facilitate diagnosis to a treating physician. Thus, for example, with such a balloon catheter device according to the invention, this implanted catheter system intermittently block the blood flow, eg in a peripheral pulmonary artery branching and thus establish a pressure equalization via the downstream capillary area to the left atrium of the heart, whereby this blockage takes place only briefly for a measuring procedure with the aid of the balloon catheter according to the invention to prevent clots from clotting.

An embodiment of a fully implantable catheter device according to the invention and in particular a further cumulatively or alternatively possible embodiment of the above-described balloon catheter device according to the invention may comprise a puncture container puncturable with a hollow needle from outside the body, the volume of which is in fluid communication with a catheter-end insertable into a blood vessel, in particular a sensor-carrying end in particular wherein the fluid connection is through a channel disposed in the catheter shaft.

Here, under said hollow needle, a e.g. conventional needle used in the medical field, such as a syringe needle or a puncture needle expressly used for the purpose. It is thus possible to puncture the puncture container by means of such a hollow needle and thus to provide access to the catheter end, which is insertable into a blood vessel. In this case, provision may be made for the puncture container to be positioned near the skin of a living being in order to achieve tactility from outside the body. After examining the puncture container, an examining doctor can then pierce it with a needle and carry out an examination. The puncture area of such a puncture container may e.g. have an elastic membrane which recloses after a puncture, such as e.g. a silicone membrane.

For example, the blood pressure at the catheter end, which also prevails in the puncture container due to the fluid connection, through a hollow needle measured outside the body. A possible attenuation by the small diameter inside a hollow needle are negligible, since it is essentially at least static pressures at the pressures to be measured, in particular when using a catheter with balloon and after a previous inflation of the balloon.

In order to carry out such a pressure measurement, a catheter must therefore not always be set again for each new measurement by means of the catheter device according to the invention with or without a balloon, but puncturing of the puncture container is sufficient. This is significantly less stressful for living organisms to be examined.

In this case, it may be provided that the end of the channel between puncture container and catheter tip is open and to allow a direct blood passage or the end is closed by a particular elastic membrane or film which is yielding under the blood pressure at the catheter end, so that the pressure through the membrane is transferred to the interior of the puncture container, which is then preferably fluid-filled, for example with a liquid such as isotonic saline or similar suitable liquids.

In a preferred embodiment in conjunction with a balloon catheter device, the puncture container may be structurally integrated with the body-internal actuator. It may also be a completely separate container, which is connected via an additional channel line with the catheter tip, ie, for example, opens into the catheter shaft and continues to the end of the catheter. Thus, actuator and puncture container can also be positioned at different and spaced apart locations in the body of a living being. A non-balloon catheter device may eliminate an actuator, and such a catheter device generally comprises a puncture container in fluid communication with a catheter end insertable into a blood vessel, such as via a channel in a catheter shaft, as aforesaid. Also Here, a sensor can be arranged in the catheter end, as described for the balloon catheter. Its associated transmitting device, in particular transponder device can then be arranged, for example, in the puncture container and in turn be connected to the sensor via a line connection through the catheter shaft. Essential in such a catheter assembly with or without balloon is that it is completely implantable in the body of a living being.

These aforementioned embodiments are also of great advantage in particular when a catheter or balloon catheter device according to the invention is used, which carries a sensor at the end which can be introduced into a blood vessel, as has been described above. Thus, by means of such a device, both measured values are available that are obtained by a sensor, including those, in particular pressure measured values, which can be obtained by puncturing the puncture container with a needle. This allows an adjustment or calibration of a sensor in the (balloon) catheter end done, for. B. if a comparison of the measured values obtained in both ways is made. The problem of drift of implanted sensors can be compensated for by recalibrating at regular intervals.

An embodiment of the invention is shown in the following figures. Show it:

Figure 1 is a plan view of a balloon catheter according to the invention

Figure 2 is a side sectional view of the same balloon catheter

Figure 3 is a sectional view through the actuator of the balloon catheter

FIG. 1 shows a preferred and structurally simple embodiment of a balloon catheter device 1 according to the invention, which has a catheter shaft 2 which is designed in terms of its diameter such that this catheter shaft is insertable into a blood vessel. At its end of the catheter shaft 2 to be introduced into the blood vessel, a sensor 4 is arranged here in order to be able to absorb physiological measured variables from a blood vessel, such as, for example, blood pressure, temperature, oxygen saturation or the like. In front of the absolute end of the catheter is a balloon 3 which is inflatable and deflatable by the catheter shaft 2. This balloon 3 is formed, for example, in that an elastic sheath surrounds the catheter shaft 2 in a sealed manner and in this case spans at least one radial bore to the channel 5 lying in the catheter shaft 2. In this way, can be displaced from the actuator 8, which is arranged at the other end of the catheter shaft 2, not shown here fluid through the channel 5 in the catheter shaft 2 into the balloon 3, whereby it can be enlarged and close a blood vessel.

The actuating device 8 is here essentially designed as a pressure cell, which forms a container which is filled with the actuating fluid and is connected to the balloon via the channel 5 in the shaft 2 of the catheter. Thus, when a pressure is exerted on the actuator 8, fluid is displaced from the actuator 8 into the balloon. If the pressure exerted removed, it may be provided that the fluid is automatically pushed back by the residual stress of the shell of the balloon 3 and / or a diaphragm 9 in the actuator or it may be provided that in the actuator a restoring force is realized , For example, characterized in that a spring element is arranged in the actuating device, which counteracts the volume change caused by the original force / pressure.

To allow fluid displacement from the actuator 8 by a force application or external pressurization, it may be provided here that the housing of the actuator 8 has a flexible membrane 9, which from the outside, for example, through the skin 10 of a Patient can be pressed in eg by means of a finger. For this purpose it is provided, as it is the figure 2 shows that at least the end of the catheter assembly 1, which has the actuator 8, is placed close to the skin of a patient.

FIG. 3 shows here the possibility of effecting a displacement of the membrane 9 and thus a change of the volume in the container of the actuating device 8 due to the effect of a force F or a pressure P in the direction of the arrow.

The aforementioned spring may for example be arranged such that one end of the spring is supported directly on the diaphragm 9 and the other end of the spring on the opposite housing wall of the actuator 8.

It can also be seen here in FIGS. 2 and 3 that the actuating device 8 additionally has a transponder device 7, which can be provided for receiving measured variables recorded by the sensor 4 by an electrical supply line 6 in the shaft 2 and e.g. electromagnetically, for example by means of RFID technology, to transmit through the skin 10 to the outside to a reading station, not shown here.

Here it can also be provided that, for an alternative actuation of the membrane 9, this can have a further element, for example a magnetic element, so that the membrane can be moved and thus actuated by a magnet arranged outside the body. In such an embodiment, then, the housing of the actuator 8 may preferably consist of a non-ferromagnetic material.

Overall, it may be provided for the inventive device of the type shown here in Figures 1, 2 and 3 and generally of the type described above, that the device 1 is enveloped by a biocompatible material or consists of such a material. In another embodiment, not shown here, it may be provided that a fluid pump is arranged within the actuating device shown here, which can be actuated manually, for example, by the elastic membrane 9. This may be, for example, an arrangement of the type described above by piston and cylinder, for example in the manner of a syringe.

Claims

claims

A balloon catheter device comprising an inflatable and deflatable balloon insertable into a blood vessel, in particular disposed at or in the region of a catheter end, and an actuating device for actuating the balloon, characterized in that the balloon catheter assembly (1) in its entirety enters the body of a balloon Living organism implantable and located in the body actuator (8) from outside a body is actuated.

2. Balloon catheter device according to claim 1, characterized in that an actuating device (8) and a balloon (3) are arranged at opposite ends and connected by a catheter shaft (2), in particular wherein an actuating device (8) is arranged outside a blood vessel ,

3. Balloon catheter device according to one of the preceding claims, characterized in that an inflation / deflation of the balloon (3) can be generated by a between balloon (3) and actuating device (8), in particular by a catheter shaft (2) reciprocating fluid, in particular air or gas or liquid.

4. Balloon catheter device according to one of the preceding claims, characterized in that by actuation of the actuating device (8), a flow of fluid at least in the balloon (3) is effected, in particular wherein a backflow into the actuating device (8) takes place automatically after actuation , in particular by a force restoring the actuating device (8).

5. Balloon catheter device according to one of the preceding claims, characterized in that the actuating device (8) comprises a fluid pump which is manually or electrically and / or magnetically actuated, in particular wherein the fluid pump is a piston and cylinder arrangement.

6. Balloon catheter device according to claim 5, characterized in that the

Actuating device, in particular the fluid pump has a drive, in particular an electric and / or piezo motor, which receives its energy by an electromagnetic coupling from the outside.

7. balloon catheter device according to one of the preceding claims, characterized in that the actuating device (8) is designed as a container from which fluid by an external force and / or pressurization (F / P) is displaceable.

8. Balloon catheter device according to one of the preceding claims, characterized in that the actuating device (8) comprises a heat-expanding fluid and / or gel, in particular the heating thereof is carried out by irradiated from outside the body energy.

9. balloon catheter device according to claim 8, characterized in that the

Fluid / gel comprises an inductively heatable substance or particles, in particular iron oxide nanoparticles.

10. Balloon catheter device according to one of the preceding claims, characterized in that the actuating device is arranged in the balloon.

11. Balloon catheter device according to one of the preceding claims, characterized in that it comprises means for monitoring and / or limiting a maximum balloon expansion and / or a maximum pressure in the balloon (3), in particular to prevent blood vessel damage.

12. Balloon catheter device according to one of the preceding claims, characterized in that the body-internal actuating device (8) is associated with a body-external actuating device for particular intermittent actuation / activation / triggering.

13. Balloon catheter device according to one of the preceding claims, characterized in that it comprises a sensor (4), in particular in the region of an insertable into a blood vessel catheter end for detecting at least one physiological measured variable and a sensor (4) connected to the transmitting unit, in particular transponder unit ( 7) for the wireless transmission of this at least one measured variable to a body-external reading station.

14. Balloon catheter device according to claim 13, characterized in that the transmitting unit, in particular transponder unit is arranged in the body-internal actuating device.

15. Balloon catheter device according to one of claims 13 or 14, characterized in that the reading unit is arranged in a body-external actuating device.

16. Catheter device having a catheter end insertable into a blood vessel, in particular a balloon catheter device according to one of the preceding claims, characterized in that it comprises a puncture container puncturable with a hollow needle from outside the body, the volume of which is in fluid communication with a catheter end insertable into a blood vessel in particular wherein the fluid connection is through a channel disposed in a catheter shaft.

17. Catheter device, in particular balloon catheter device according to claim 16, characterized in that it comprises a sensor, in particular in the region of an insertable into a blood vessel catheter end for detecting at least one physiological measurement and connected to the sensor transmitting unit, in particular transponder unit for wireless transmission of these at least one Measured variable to a body-external reading station.

18. Catheter device, in particular balloon catheter device according to claim 17, characterized in that the transmitting unit, in particular transponder unit with the puncture container is structurally integrated.

9. balloon catheter device according to one of claims 16 to 18, characterized in that the puncture container is arranged in / on the body-internal actuating device.