EP0205817B1 - Treatment system with sleeve and control device - Google Patents

Abstract

Treatment devices, comprising a cuff (40) made up of individual chambers (39) and produced from flexible material, a control facility for successively filling the individual chambers (39), and connection elements (2-10) which at least connect the individual chambers (39) to the control facility (13, 16, 18), and at least one fluid pump (44) which is connected to the individual chambers via the control facility, are known for the decongestion of the human extremities or for performing gentle massage. Similarly, with these devices, blood can be forced in specific directions in order to obtain a congestion of blood or accumulation of blood in a specific organ. However, a modified mode of operation of these known devices permits the expulsion of the thrombus or the complete emptying of blood from specific areas of the body. For this purpose, it is proposed that the individual chambers (39) be inflated individually, one after the other in a predetermined sequence, with a pressure of at least 250 millibar, the filling of a subsequent chamber beginning only when the set pressure is achieved in the preceding chamber. <IMAGE>

Description

The invention relates to a treatment device with a flexible cuff composed of individual chambers, at least one fluid pump, a control device and with connecting elements for connecting the pump, control device and cuff and with devices for adjusting and / or regulating the fluid pressure, which is an adjustment and / or regulation allow the fluid pressure also in the range of more than 250 mb, the fluid pump being suitable for generating such a pressure.

An above. Establishment as such is known and is also used. Such a device has become known, for example, from US Pat. No. 4,311,135. These devices are used to improve venous circulation, decongest the treated tissue (removal of tissue water) and for thrombus treatment. The individual chambers of the cuff described there are inflated by a fluid with a pressure of approximately 40 mb (see column 3, line 67). The individual chambers of the cuff are controlled via a continuously rotating distributor, so that the rotational speed of the distributor is decisive for the degree of filling and thus for the internal pressure of the chambers. The pressure of the individual chambers must be regulated as the speed of rotation of the distributor. If this speed of rotation is constant, the pressure in the chambers differs from person to person because the cuff is filled differently due to the different sizes of the treated extremities. The system is - if also conditional - suitable for the intended purpose.

A similar device has become known with the Gbm 76 07 135. There it is stated on page 1 paragraph 2 that such a device should be suitable for carrying out a very careful massage in order to avoid damaging sensitive tissue. This means that a pressure of the same order of magnitude as in US Pat. No. 4,311,135 (40 mb) can also be used here.

A device according to DE-OS 28 14 691 is also comparable. According to this reference, an operating pressure of about 40 mm Hg is given on page 10, paragraph 3, which corresponds to a pressure of about 55 mb.

A very early device of the type mentioned is known from DE-PS 51 05 79. With regard to the fluid pressure, however, on page 2, left column, line 45 of "corresponding pressure level" is spoken of. In view of the application of this device described in this publication, a pressure of about 40-50 mb seems sufficient here, too. The recent literature mentioned above also does not indicate that it would make sense to use a higher pressure.

The two German utility models G 84 15 045 and G 84 22 047, which describe special control devices used in treatment facilities of the abovementioned, go back to the applicant himself. Kind can be included. With these control devices, cuffs of the type mentioned are controlled, which are intended for the decongesting of human extremities in accordance with these literature references. This control device ensures that the individual chambers of an assigned cuff are filled exactly one after the other when a preceding chamber has reached the set pressure. The pressure for the cuff can be set and preselected via the control device. Because of the intended use specified in these references, it must also be assumed here that an operating pressure of 40-50 mb is used.

A device of the generic type is known from FR-A-2 425 239. The individual chambers of the cuff of this device can already be filled with a pressure of more than 250 mb. However, the actual pressure in the individual chambers depends on the speed of rotation of a distributor. However, there is no information about the filling speed of the chambers up to a certain filling pressure. However, all chambers are filled and emptied in constant repetition.

Thrombus treatment has also already been mentioned in various of the publications cited above relating to the prior art. However, the use of the devices described is intended to prevent the formation of a thrombus or to dissolve an existing thrombus. However, it is often necessary to remove a thrombus. There are various options for this. As far as the thrombus is surgically removed, different measures can be differentiated here. For example, the vein in which the thrombus is inserted can be cut open and then a thin, inflatable cannula can be pushed through the thrombus and inflated or inflated behind it, so that the entire free vein cross section is filled. Then this device is pulled forward and the thrombus is transported with it. It is a complicated method that places relatively high demands on the manual dexterity of the attending doctor.

Sometimes a thrombus, when the vein has been cut open at the appropriate point, can also be expressed by wiping the vein with your finger or thumb. This must be done sufficiently quickly and vigorously so that the still liquid blood behind the thrombus can be used as a pressure medium during this expulsion, which drives the thrombus in front of it to the point at which the Vein is open so that the thrombus can be expelled here. For this, however, the course of the wire must be clearly recognizable and the course of the wire must be followed exactly during the manual driving process in order to achieve the desired effect. Here too, high manual dexterity is required.

Another problem in medicine is the voiding of certain parts of the body to be operated on.

The invention has for its object to provide a device to enable blood to be drained from certain extremities or thrombus.

The solution to this problem lay in the knowledge that, with the help of the devices of the type described at the outset, a sleeve composed of individual chambers and made of flexible material, a control device for successively filling the individual chambers and connecting elements which connect at least the individual chambers to the control device , as well as at least one fluid pump which is connected to the individual chambers via the control device, if these devices are operated in such a way that the individual chambers are filled one after the other in a predetermined order with a pressure of at least 250 mb, the filling of a subsequent chamber only beginning If the set pressure in the previous chamber is reached, the blood can become empty or the thrombus may be thrown out. With the pressure applied, it is possible to make the body part enclosed by the individual chambers bloodless by the progressive filling of the individual chambers. Here, the fact that a previous chamber really has to be filled with the desired pressure before the next chamber is filled ensures that a reliable propulsion of the blood flow is achieved, which is not hampered by an early partial filling of further lying chambers. Due to this safe propulsion effect under sufficient pressure of the individual chambers, which can be used up to 600 mb, a thrombus can be expelled even if the vein is opened accordingly. In addition, if the individual chambers are layered with a certain mutual overlap, undesired seams between the individual chambers can also be avoided and the blood is really transported without obstructing seams. Loss of transport caused by the interface between two adjacent individual chambers is thereby reliably avoided. The filling of the chambers only once instead of the constant repetition of filling and emptying makes it possible to maintain the final state. In this case, a control or regulation of the filling speed of the individual chambers is carried out, with a subsequent chamber being filled without intermediate time when the previous chamber is filled. This control or regulation of the filling speed can influence the advance speed of the blood in the treated limb. At the same time, the speed can also be varied during a single treatment cycle. For example, At the beginning, the first individual chambers are filled quickly and the filling speed of the individual chambers is reduced towards the end. The reverse process is of course also possible. The fact that the successive chambers are filled without intermediate time ensures, on the one hand, a continuous transport of the blood in the desired manner and, on the other hand, avoids unnecessarily large stress on the extremity being treated. The quantity control of the fluid must be such that it can be filled up sufficiently quickly to drive out a thrombus on the cut vein. The quantity control must also allow an adapted filling speed for emptying the treated limb. Of course, the pump must be designed so that it can deliver the necessary amount of fluid at the desired pressure. A device according to the aforementioned utility models G 84 15 045 and G 84 22 043 has proven itself as the starting device for carrying out the method according to the invention. Such a device can be supplemented with relatively simple and known technical means so that a device according to the invention is created. The description and mode of operation of a control according to the utility models mentioned can be found in these utility models. Such a control device together with a suitable cuff can, for example, be used to. drive out a thrombus with the vein open. All that is required is for the cuff with its foremost chamber to be arranged behind the point at which the vein clogged by the thrombus is opened, care being taken to ensure that there are sufficient chambers also behind the thrombus. In this arrangement, the individual chambers are then quickly filled with the necessary pressure from the fluid via the control device mentioned, as a result of which the thrombus is rapidly propelled forward and expelled at the opening point of the vein. At the same time, the surrounding tissue is decongested.

The use of such a device containing a control device and cuff can easily be seen in the accompanying drawings. The cuff connected to the control device is placed around the extremity in the correct position, for example in relation to the thrombus, in the manner already described. The control device must now be connected to the pressure source for the fluid. The mass flow must be transported via the pressure source or the control device itself be determined fluids. However, such a determination of the mass flow is preferably carried out using a suitable quantity adjuster. The cuff pressure to be reached by the fluid being transported must also be determined. For this purpose, the control devices have corresponding setting and control devices. In the case of a control device according to the utility models mentioned, this pressure of the fluid in the cuffs is determined via the control pressure, as can be seen from the utility models mentioned.

• Figur 1 Beinstück mit Beinmanschette und eröffneter Vene
• Figur 1a schematischer Aufbau der Behandlungseinrichtung mit Steuereinrichtung
• Figur 2 Beinstück und Manschette mit einer Anzahl aufgepumpter Einzelkammern
• Figur 3 Darstellung wie Figur 2, jedoch sind alle Einzelkammern aufgepumpt

The drawings show:

• Figure 1 leg piece with leg cuff and opened vein
• Figure 1a schematic structure of the treatment device with control device
• Figure 2 leg piece and cuff with a number of inflated individual chambers
• Figure 3 representation like Figure 2, but all individual chambers are inflated

In order to drive out a thrombus in a leg vein 1/9, a cuff 1/2 known per se with single chambers 1/3 is placed around the leg 1/1 in the arrangement shown in FIGS. 1, 2 and 3 and over the envelope 1 / 5 closed with the closures 1/10. As shown in Figure 1, the 1/9 leg vein is opened and the 1/2 cuff is positioned to lie between the 1/8 foot and the 1/9 leg vein opening site. The thrombus must be axially in the area of cuff 1/2. The control lines 1/7 are attached to the connectors 1/6 of the sleeve 1/2. The control lines 1/7 are connected via the connectors 1/6 to the connection openings 1/6 'of the individual chambers 1/3, so that each individual chamber 1/3 is assigned a control line 1/7. In this way, all individual chambers 1/3 can be supplied with a fluid in a desired order via the control line 1/7.

In the exemplary embodiment the cuff 1/2 is connected to a control device according to one of the two German utility models G 84 15 054.9 or G 84 22 043.0 as supplemented in the manner necessary for the invention and shown in this supplement in FIG. 1. In the manner described in the utility models, the control lines 1/7 are connected to the control device described there. The control lines 1/7 correspond to the control lines 2-10, according to FIG. 1a. The control lines 1/7 or 2-10 are then supplied with fluid from such a control device according to FIG. 1, as indicated by the arrows 1/11 in FIG. 1. The pressure of the fluid is determined via the control device and can be preset via the correspondingly controllable pressure source 42, which is connected to a control or regulating device 46 via a control line 50. The actually occurring control pressure in the control pressure line 12 can then be read on the manometer 49. The control pressure line 12 is also connected to the control or regulating device via the control pressure line 12a. As a result, the setpoint size and the actual size can be supplied to the device 46 if required.

The mass flow of the fluid is determined by the pump output of the pump 44 for the fluid, which is connected to the control device according to FIG. 1a via the inlet connection 1. In order to be able to use the entire device not only in a conventional manner but in a manner according to the invention, the pump 44 must be able to deliver the necessary amount of fluid at the desired pressure. In order to be able to operate the entire device economically using both the conventional method and the method according to the invention, it may be advantageous not to install the pump 44 as a single pump, but in the form of several pumps. The delivery rate can be changed as required by switching on several pumps. To regulate the mass flow, however, a quantity adjuster 47 can also or additionally be provided in the inlet connection 1, which is connected again via a control line 51 to the control or regulating device 46 already described and receives control or regulating pulses from there. To return the actual size, the device 46 is connected to the outlet connections 2-10, which correspond to the connections 1/7 according to FIG. The pressure arriving in the inlet connection 1 can be read off on the manometer 48.

If you do not want to work with a maximum power and thus with the maximum traveling speed with which the successive individual chambers are filled, to expel a thrombus or to empty an extremity, a very simple computer in the control or regulating device 46, which measures the speed, is sufficient of the pressure rise in the respectively assigned line 2 to 10 can calculate the filling speed and thus the mentioned moving speed and then regulates the volume adjuster 47 accordingly via the control line 51. The control can also be carried out according to a predetermined speed program.

In the exemplary embodiment, the individual chambers 39 correspond to the individual chambers 1/3 according to FIG. 1. The individual chambers 39 according to FIG. 1a are only shown schematically and are all directly adjacent to one another, while the individual chambers 1/3 according to FIG. 1 are arranged in mutual overlap. The mutual overlap prevents undesirable losses in the border areas between two chambers.

In the exemplary embodiment, the thrombus is expelled when the individual chambers 1/3 according to FIG. 1 are inflated rapidly at the foot 1/8 beginning in the direction of arrow 1/4 with the necessary pressure. This requires a pressure of at least 250 mb. If necessary. but a pressure of 500 to 600 mb can also be used and necessary. It is first done with the help of the control device the necessary pressure is set and a sufficient flow rate of the fluid must be ensured via the pump output for the fluid. When dimensioning the control device, it must of course be ensured that it is sufficiently large to enable the necessary fluid throughput at all. The exact setting of the fluid throughput can then be made via the volume adjuster 47. If the prerequisites mentioned are met, the control lines 1/7 (or the corresponding lines 2-10) are activated one after the other by the control device in the order just described and the assigned individual chambers 1/3 or 39 with the desired speed and the set pressure filled with the required fluid. This creates an expulsion movement in the direction of arrow 1/4, so that the thrombus is safely expelled from the opened vein 1/9.

The same procedure is followed to make an extremity bloodless. It is only necessary to use suitable means, e.g. blood flow can be prevented by a ligature.

FIG. 1a shows a longitudinal section through a control body that can be used for the implementation of the invention, as can be seen in the two German utility models mentioned, to which express reference is made. A cylindrical control body 13 is used here. The entire length of the cylindrical control body 13 is covered with a tubular rubber skin as the membrane 29. The control body 13 covered in this way with the membrane 29 is inserted with radial play in a tubular hollow body 18 which is approximately the same length as the control body 13. This hollow body 18 points nearby of the rear end on a radially directed inlet opening 37, which is equipped with a hose connector 41. Hose connector 41 is connected via a control pressure line 12 to a pressure source 42 for flow medium. The pressure source 42 can be connected to a control or regulating device 46 via a control line 50.

The radial space between the outer surface of the membrane 29 and the inner surface of the hollow body 18 is sealed in the region of the two ends of the hollow body 18 with an O-ring 25 and 26, respectively.

The control body 13 has a number of annular channels 33 on its surface, which are delimited by annular intermediate webs 32. In each of these annular channels 33 there is an outlet opening 34 and 35, each subsequent outlet opening 34 preferably being arranged somewhat offset in the circumferential direction with respect to the previous outlet opening 34.

On the front side 22 of the control body 13 from the front side and distributed in the circumferential direction, an inlet connection 1 and the outlet connections 2 to 10 are arranged. The connections 1 to 10 mentioned are each connected to the outlets 34 and 35 via longitudinal bores in the control body 13. For example, inlet port 1 is connected to outlet 34. The outlet port 2 is connected to the lowest outlet 35 in FIG. 1a, etc. Behind the last annular channel 33 for the last outlet 35, which is connected to the outlet port 10, a further ring channel is provided in the control body 13, in which a plurality of Exits 36 is arranged, which are all connected to the outlet connection 11 arranged on the rear end face 21 via assigned channels. This outlet port 11 can lead directly into the free atmosphere 38, or serve as a connector to other devices, in the embodiment with a silencer 43. When sealing via the O-rings 25 and 26 it should be noted that the O-ring 25 before the first outlet, that is, before the outlet 34, and that the O-ring 26 is arranged behind the last outlet, that is, behind the outlets 36, which lead into the outlet connection 11. It is entirely possible to provide annular channels for the O-rings 25 and 26 on the control body 13, as a result of which a better axial fixation of these O-rings is achieved and, at the same time, a better sealing of the membrane due to the clamping of the membrane 29 in the channels 31 29 compared to the control body 13 is reached.

The outlet connections 2 to 10 are each connected to an assigned individual chamber 39 or 1/3 via suitable lines, all of the chambers 39 and 1/3 being combined to form a sleeve 40 or 1/2. These single chambers can e.g. form annular hoses, so that the resulting cuff 40 or 1/3 e.g. can be placed over an arm or over a leg. The individual chambers 1/3 are advantageously arranged in mutual overlap in the cuff 1/2.

The inlet port 1 is connected to a pressure source 44, which is suitable to fill the chambers 39 and 1/3 and thus the sleeve 40 and 1/2 in the desired manner with pressure medium. The filling speed is influenced on the one hand by the pump power 44 and on the other hand by the setting of the volume control 47. All connections are routed internally to the connecting disk 16, it being possible for there to be arranged connecting tubes, which are not specified on the end face or on the circumference.

According to the invention, a treatment device known per se is thus improved in terms of device technology in such a way that a pressure which is often higher than that of the conventional devices of the prior art can be achieved and a higher filling speed is achieved. At the same time, it is possible to interrupt the previously known and usual constant repetition of filling and emptying and to keep the filled state after a filling process.

Claims (1)

1. Treatment apparatus comprising a flexible sleeve (1/2; 40) composed of individual chambers (1/3; 39), at least one fluid pump (44), a control device, and connecting elements for the connection of pump, control device and sleeve and with devices (46) for the setting and/or control of the fluid pressure which permit a setting and/or control of the fluid pressure in the region of more than 250mb, with the fluid pump (44) being suitable for the creation of such a pressure, characterised in that the fluid pump (44) supplies a quantity of fluid which permits a sufficiently rapid filling speed for the sleeve (1/2; 40) for the expulsion of a thrombus, and in that means are provided for the setting and/or control of the fluid throughput.

Images