• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A medical device for shutting off a body canal, comprising a band part (1) which can be laid around the body tissue (2) surrounding the body canal and can be closed to form a ring surrounding a passage opening (4) for the body tissue (2), and which is a hollow chamber (3), which constitutes part of a receiving space of the working fluid receiving means, and a pumping unit (10) for conveying the working fluid. By introducing the working fluid into the hollow chamber (3), the passage opening (4) can be reduced in size. The device has an expansion body (20) with an expansion chamber (21), wherein the expansion body (20) in the receiving space for the working fluid or at one of the passage opening (4) facing side of the hinge part (1) on the band part (1) is arranged, and by introducing an auxiliary fluid separated from the working fluid into the expansion chamber (21), the expansion chamber (21) can be enlarged.
    公开号:AT518411A4
    申请号:T294/2016
    申请日:2016-06-14
    公开日:2017-10-15
    发明作者:Jablonowski Marc；Hohlrieder Martin
    申请人:Ami Agency Medical Innovations Gmbh；
    IPC主号:
    专利说明:

    The invention relates to a medical device for shutting off a body passage, comprising a band part which can be laid around the body tissue surrounding the body passage and can be closed to form a passage opening for the body tissue surrounding ring and which has a hollow chamber which forms part of a receiving space of the Represents means for receiving working fluid, and a pumping unit for conveying the working fluid, wherein by introducing the working fluid into the hollow chamber, the passage opening is reduced in size.
    Medical facilities for shutting off a body passage are i.a. used as artificial (closing) muscles to support or replace weakened natural muscles in the human or animal body. Examples of applications of such devices are anal tapes for closing a, possibly artificial, anus and artificial sphincter for the treatment of incontinence for closing the urethra (= urethra). Further fields of use are e.g. Ligaments for closing a duct for bile. The band portion of such medical devices is also referred to as a cuff, cuff or artificial sphincter.
    If required, the hollow chamber of the band part can be emptied by the user in order to increase the cross-sectional area of the passage opening and to allow substances and / or liquids contained in the body passage to pass. For example, when used as an artificial sphincter for the urethra is often followed by a subsequent automatic closing of the body passage by pumping back working fluid (possibly, via a throttle valve) in the hollow chamber of the hinge part. A pump for pumping working fluid is usually implanted in the scrotum in such an artificial male urinary sphincter. The
    Pumping of working fluid from the hollow chamber can then be done by pressure on a flexible part of the pump. The pumping back of working fluid in the hollow chamber can be done by a resilient element of the pump. The passage opening of the medical device can often also be reduced again by a conscious action of the user, that is to say by manual actuation of the pump. For example, From US 2014/0364686 A1, several embodiments of medical devices in the form of Urethrasphinktern are known, which have a band part with two hollow chambers. An intermediate wall, which separates the two hollow chambers from each other, has a valve which allows a fluid exchange between the hollow chambers. By means of a pump, the fluid can be transferred to open the body passage of one of the hollow chambers in the other hollow chamber.
    A problem with medical devices for narrowing or shutting off a body passage is that they can cause erosion of the body tissue due to the pressure exerted on the body tissue by the device. Therefore, the pressure of the working fluid in the hollow chamber is usually chosen so that the erosion of body tissue can be kept as low as possible while still a reliable shut-off of the body passage is achieved.
    In a tension of the abdominal muscles, such as when climbing stairs, lifting loads, sneezing, coughing, laughing, usually occurs involuntarily, there is a short-term intra-abdominal (= within the abdominal cavity) increase in the body's internal pressure. In this case, the short-term pressure peaks act in particular on the inner (hollow) organs arranged in the abdominal cavity, e.g. Bladder and intestine. As a result, the pressure in the (hollow) organs increases, which can lead to leakage of substances and / or liquid through the portion of the body passage closed off by the band part. This type of incontinence is also referred to as stress incontinence or stress incontinence.
    US Pat. No. 5,478,308 A discloses a medical device of the type mentioned at the outset for the treatment of urinary or fecal incontinence. The designated in this document as a cuff band part is made of silicone. By filling the cuff with working fluid, the pressure in the cavity of the cuff increases, whereby the displacement of an inner portion of the cuff in the direction of the longitudinal central axis caused thereby closes off the body passage. Between two parts of a connecting line, which fluidly connects a pump to the cuff, a flexible balloon (= "stress balloon") made of silicone is arranged. The cavity of the stress balloon is filled with working fluid. A short-term increase in internal body pressure causes a volume reduction of the cavity of the stress balloon, displacing working fluid into the cuff. By briefly increasing the pressure of the working fluid, the body passage can be kept shut off during a stress event and leakage prevented. When the internal body pressure subsequently decreases again, the volume of the cavity of the stress balloon increases and the pressure of the working fluid decreases, with working fluid flowing out of the cuff. If the pressure of the working fluid in the cuff to close the body passage increases, so does the volume of the balloon, so that by means of the pump a correspondingly large amount of fluid must be moved.
    The object of the invention is to provide an advantageous device of the type mentioned, which can be used for the treatment of stress incontinence.
    According to the invention, this is achieved by a device having the features of claim 1.
    The device according to the invention has an expansion body with an expansion chamber, wherein the expansion body is arranged in the receiving space for the working fluid or at one of the passage opening facing side of the hinge part on the band part. By introducing a separate from the working fluid
    Auxiliary fluids in the expansion chamber, the expansion chamber is enlarged. The expansion chamber is thus filled independently of the working fluid with the auxiliary fluid.
    Upon the occurrence of a stress event, e.g. caused by an increase in the body internal pressure in a coughing fit, an expansion of the expansion chamber, whereby an additional force can be applied to the guided through the passage body tissue. The body passage is thus reliably shut off even during a stress event. During a stress event, the body pressure (= ambient pressure) is above the atmospheric pressure.
    The auxiliary fluid is desirably completely separated from the working fluid, i. that no fluid exchange takes place between the auxiliary fluid and the working fluid.
    By providing two independent fluid systems, additional options for designing the medical device can be obtained.
    The enlargement of the volume of the expansion body by filling of auxiliary fluid in the expansion chamber takes place in particular by stretching or unfolding of the expansion body.
    It can be provided that the expansion body is elastically extensible. In other embodiments, however, the expansion body can also be formed from an at least substantially inextensible material. Thus, a bellows closed on both sides could be provided, which expands by filling auxiliary fluid into the expansion chamber. In principle, it is also conceivable and possible for the volume change of the expansion body to take place by displacing at least one displaceable wall of the expansion body. The sliding wall could e.g. a piston which is movable by filling auxiliary fluid in the expansion chamber.
    As a receiving space for the working fluid in this document, the entire inner cavity of the device is referred to, in which there is working fluid in the operation of the device. For example, in the case of disposing the expansion body in the working fluid accommodating space, the expansion body may be disposed in the hollow portion of the band portion or a working fluid passage connecting the hollow chamber to the pump unit. Particularly preferably, the expansion body is arranged in the pump unit.
    Conveniently, the pumping unit has a pumping part which has an interior space for accommodating working fluid whose volume can be changed by means of a drive. In an arrangement of the expansion body in the pump unit is advantageously provided that the expansion body is arranged in the interior of the pump part.
    By means of the pump unit, working fluid can be introduced into the hollow chamber of the band part. By moving one of the passage opening facing the inner portion of the hinge part in the direction towards a longitudinal central axis of the passage opening of the body passage can be shut off.
    The expansion body is in the embodiment in which the expansion body is arranged in the receiving space for working fluid, thus surrounded by the working fluid during operation of the device. When filling the expansion chamber with auxiliary fluid and the resulting increase in volume of the expansion chamber, an increase in the pressure of the working fluid, wherein the inner portion of the hinge portion is further displaced in the direction of the longitudinal center axis of the passage opening. It comes thereby to a greater compression of the body tissue surrounding the body tissue.
    In an embodiment according to the invention, in which the expansion body is arranged on one of the passage opening facing side of the band part on the band part, ie on the inner portion of the band member, a filling of the expansion chamber with auxiliary fluid by the thereby effected enlargement of the acts
    Volume of the expansion chamber directly compressing on the surrounding the body passage body tissue in order to ensure a reliable shut-off of the body passage during a stress event.
    The filling of the expansion chamber could in principle be carried out with a sensor-controlled auxiliary fluid pump, wherein an increase in pressure in the interior of the body could be detected by a pressure sensor and a dependent activation of the auxiliary fluid pump could take place. In a preferred embodiment, however, the device has an auxiliary fluid reservoir with a storage chamber for the auxiliary fluid, the volume of which can be changed as a function of the ambient pressure. The auxiliary fluid reservoir is connected to the expansion chamber via an auxiliary fluid line.
    The auxiliary fluid reservoir is conveniently implantable in the body, particularly in the abdomen, with the body internal pressure acting on the body acting on the auxiliary fluid reservoir. Conveniently, then the pressure of the auxiliary fluid corresponds to the body internal pressure. When tensing abdominal muscles during a stress event, the volume of the reservoir chamber of the auxiliary fluid reservoir changes depending on the body internal pressure. In this case, auxiliary fluid is ejected from the storage chamber and passed through the auxiliary fluid line into the expansion chamber. For the delivery of auxiliary fluid thus no additional pump is needed. Conveniently, the auxiliary fluid container has a flexible wall bounding the storage chamber. Under flexible in this context a bendable wall is considered, but which does not necessarily have to be stretchable. On the contrary, the flexible wall is preferably at least substantially inextensible. When filling the auxiliary fluid tank then no material expansion takes place, i. that the volume of the storage chamber can be increased only by unfolding the flexible wall. The volume of the storage chamber is conveniently limited to a maximum storage volume of the storage chamber.
    In an advantageous embodiment, it is provided that the storage chamber bounding flexible wall is formed slippery. That is, the wall does not return by itself (= without external force) to an earlier shape. In a slippery wall formed the auxiliary fluid container could also be referred to as formlabil.
    In another embodiment could be provided as an auxiliary fluid container, for example, a double-sided sealed bellows, wherein the volume of the storage chamber can be increased by expansion of the bellows.
    In principle, however, it would also be conceivable that the auxiliary fluid container has at least one displaceable wall, e.g. in the manner of a piston.
    Advantageously, it is provided that the volume of the expansion chamber is at least substantially equal to zero at a working fluid which is at a higher pressure than the pressure of the auxiliary fluid. If in the release state, the volume of the expansion body is substantially equal to zero or relatively low, so when adjusting the band portion from the release state to the shut-off state, no or little auxiliary fluid must be conveyed from the expansion chamber into the storage chamber of the auxiliary fluid reservoir. As a result, the amount of working fluid to be displaced can be minimized. In the case that the medical device has an electrically operated pumping device, thereby energy saving can be realized.
    Further advantages and details of the invention are explained below with reference to the accompanying drawings. In these show:
    1 shows a schematic representation of a device designed as an artificial urethra sphincter, in a release state of the strap part in which the ureter is opened;
    FIG. 2 shows a representation analogous to FIG. 1 in a shut-off state of the band part in which the ureter is closed; FIG.
    Fig. 3 is a view analogous to Figure 1 in a stress state of the band part in which an additional force is exerted on the ureter.
    4 and 5 are oblique views of the free, that is not implanted, band portion of the device in an open and closed state, in accordance with the release state.
    6 shows a longitudinal center section (parallel to the longitudinal central axis of the passage opening and passing through it) through the band part in the state according to FIG. 5;
    FIG. 7 shows a longitudinal middle section analogous to FIG. 6, but in the shut-off state of the band part; FIG. 8 shows a schematic representation of a second embodiment of an artificial urethral sphincter in a shut-off state of the band part in which the ureter is closed;
    9 shows a representation analogous to FIG. 8 in a stress state of the band part in which an additional force is exerted on the ureter; FIG.
    10 shows a schematic representation of a variant of the band part according to the second embodiment in a shut-off state of the band part in which the ureter is closed, and
    11 shows a representation analogous to FIG. 10 in a stress state of the band part, in which an additional force is exerted on the ureter.
    A band part 1 of the medical device is annular around the surrounding the body passage body tissue 2, here the urethra, layable. The band member 1 has a hollow chamber 3 which extends in the direction of the longitudinal extension of the band member 1, in the embodiments substantially over the entire length of the band member 1. The band member 1 is thus formed like a tube with ends closed on both sides.
    At the two ends of the hinge part 1, a first and a second closure part 6, 7 are arranged. The first closure part 6 has an insertion opening 6a into which a tongue 7a of the second closure part 7 can be inserted and latched therein.
    The closure parts 6, 7 thus form a closure, with which the band part 1 to a ring, in particular circular ring, can be closed, see. FIG. 5. In the closed state, the band part 1 surrounds a passage opening 4 for the body tissue 2 surrounding the body passage.
    In the hollow chamber 3 is a working fluid, in particular a liquid, e.g. Saline. The size of the passage opening 4 depends on the amount of working fluid in the hollow chamber 3. By introducing working fluid into the hollow chamber 3, the passage opening 4 can be reduced. Here, a flexible inner portion 1a of the band member 1, which is adjacent to the longitudinal central axis 5 of the passage opening 4, displaced in the direction of the longitudinal central axis 5, as is known. By discharging working fluid from the hollow chamber 3, the passage opening 4 can be increased again.
    Fig. 6 shows the state in which the passage opening 4 is the largest (wherein the pressure of the working fluid in the hollow chamber 3 corresponds to the ambient pressure). Fig. 7 shows a filled with the working fluid state, in particular the maximum filled with working fluid state (the pressure of the working fluid in the hollow chamber 3 is above the ambient pressure). In Fig. 7 are wrinkles, as they would arise in particular, if the band part is not placed around the ureter, not shown. A remote from the Längsmitteiachse 5 back portion 1b of the band member 1 may be formed stiff relative to the inner portion 1a, in particular by means of a reinforcing layer, whereby a deformation of the back portion 1b can be at least largely avoided.
    In the closed state of the band part 1 placed around the body channel, it can thus have a release state in which the body channel is opened (cf.
    Fig. 1), and a shut-off state in which the body passage is closed (see Fig. 2), occupy. In the release state, the pressure of the working fluid in the hollow chamber 3, for example, correspond to the atmospheric pressure. In the shut-off state, the hollow chamber 3 is filled with an amount of working fluid such that the body passage is closed.
    Different modifications of the design of the strap part are conceivable and possible, it would be possible, for example, to omit special closure parts attached to the strap part 1 altogether and to sew the two ends of the strap part together.
    The band member 1 may be made of silicone in a known manner. Other biocompatible materials are basically used.
    In the exemplary embodiment, a connection piece 8 is integrally formed on one of the closure parts, the cavity of which is in communication with the hollow chamber 3 via a channel running through the closure part. Such a connection piece could also be provided at a different location of the hinge part. A trained as a hose working fluid line 9 is connected to the connecting piece 8.
    The band part 1 is connected via the channel of the working fluid line 9 with a locally separate from the band part 1 pump part 11 of a pump unit 10 in conjunction, see. 1 to 3. By means of the pump unit 10, the amount of working fluid in the hollow chamber 3 of the band member 1 can be changed.
    A receiving space for receiving the working fluid (= working fluid receiving space) of the medical device comprises the entire contiguous inner cavity of the device, in which working fluid is in operation.
    The hollow chamber 3 of the band member 1, and extending through the closure member channel of the closure part of the band member 1, and the channel of the working fluid line thus each form a part of the receiving space for the working fluid. In the exemplary embodiment, the pump part 11 of the pump unit 10 has an inner space 12 filled with working fluid, which likewise forms part of the receiving space of the device.
    For filling the receiving space of the medical device with working fluid, a port 18 is present in a conventional manner. This can be connected for example via a hose to the pump part 11.
    In the exemplary embodiments, the pump part 11 is formed by a bellows, which is closed by a bottom part 13 and a cover part, which constitutes an actuating element 14. An electric drive 15 acts via a gear 16, for example a screw drive, on the adjusting element 14 in order to change the volume of the inner space 12. The gear 16 is favorably self-locking, so that a once set position of the actuating element 14 is held without supply of electrical energy to the drive 15.
    Thus, in the exemplary embodiment, the pump part 11 simultaneously forms a reservoir for the working fluid, with which the hollow chamber 3 of the band part 1 is filled to close the body channel. The pump part 11 could for example also be formed by a piston-cylinder unit, wherein the actuating element 14 would be formed by the piston of this piston-cylinder unit.
    The electric drive 15 is driven by an electronic control unit 17 of the pump unit 10, which also has a battery, not shown, for feeding the drive 15 with electric current. The operation of the control electronics 17 by the user via a suitable, not shown user interface. The user interface may be a wired or wirelessly connected to the control electronics 17 operating unit with corresponding switches.
    The user interface may be located outside the body. An implantation of the user interface is conceivable and possible. In principle, a separate user interface could also be dispensed with, with at least one user-operable control element being arranged on the pump unit 10. This would have to be actuated accordingly from outside the body.
    The components of the pumping unit 10 are arranged in a housing 19. The housing 19 is made of a biocompatible material or is enveloped by such.
    The medical device further comprises an auxiliary fluid reservoir 22 with a storage chamber 23 filled with auxiliary fluid during operation of the device. The auxiliary fluid reservoir 22 is conveniently implanted in the body. The auxiliary fluid container 22 has a flexible wall bounding the storage chamber 23. This can be formed at least substantially inextensible.
    By "substantially inextensible" is meant the material property of the wall of the auxiliary fluid reservoir 22 in which the volume of the storage chamber 23 is reduced by less than 10% from a maximum deployed state with an increase in the pressure of the auxiliary fluid in the auxiliary fluid reservoir 22 by 0.1 bar. The auxiliary fluid reservoir 22 could have a reinforcement which conveniently has a modulus of elasticity of at least 1000 N / mm 2, preferably at least 5000 N / mm 2.
    The wall of the auxiliary fluid container 22 is formed in the exemplary embodiment also pliable, i. the wall does not return to an earlier form by itself. The wall of the auxiliary fluid container 22 could be e.g. be formed by a plastic film. The auxiliary fluid container 22 according to the embodiments shown is thus conveniently foldable, wherein the volume of the storage chamber 23 by a folding or unfolding of the auxiliary fluid container 22 in response to an ambient pressure (= body internal pressure) is variable. Conveniently, the pressure of the auxiliary fluid during operation of the device corresponds to the ambient pressure (= internal body pressure).
    The wall of the auxiliary fluid container 22 is conveniently made of a biocompatible material, e.g. Polyamide or silicone, or is enveloped by such. The optionally existing reinforcement can be embedded in this material.
    The storage chamber 23 of the auxiliary fluid container 22 is fluidly connected by means of an auxiliary fluid line 24 with an expansion chamber 21 of an expansion body 20. The storage chamber 23, the inner channel of the auxiliary fluid line 24 and the expansion chamber 21 each form part of an auxiliary fluid receiving space of the medical device. As the auxiliary fluid receiving space of the entire inner cavity of the device is referred to, in which there is auxiliary fluid during operation of the device.
    The auxiliary fluid separated from the working fluid could e.g. be introduced via a port not shown in the auxiliary fluid line 24 or directly into the storage chamber 23. The auxiliary fluid is conveniently a liquid, e.g. Saline.
    The expansion body 20 is arranged in the first embodiment in the working fluid filled with the receiving space of the device, namely in the interior 12 of the pumping part eleventh
    The volume of the expansion chamber 21 can be increased by introducing auxiliary fluid into the expansion chamber 21 by unfolding or expanding the expansion body 20. When the enlargement is purely by unfolding, the expansion body 20 may be made of an inextensible material so that the maximum volume of the expansion chamber 21 is limited. Thus, an increase in pressure of the working fluid (as explained below) is limited by the limitation of the volume of the expansion chamber 21. On the other hand, the volume of the expansion chamber 21 can be increased by an elastically stretchable design of the expansion body 20.
    The expansion body 20 may also be made pliable, i. the expansion body 20 is then dimensionally unstable, as indicated in FIGS. 1 and 2.
    At least in the shut-off state of the band part 1 shown in FIG
    Auxiliary fluid under a lower pressure than the working fluid. The expansion chamber 21 of the expansion body 20 is preferably completely folded. Thus, at least substantially no auxiliary fluid is in the expansion chamber 21. In other words, the auxiliary fluid is thus displaced out of the expansion chamber 21 into the storage chamber 23 of the auxiliary fluid reservoir 22 due to the force acting on the expansion body 20 higher pressure of the working fluid. The volume of the expansion chamber 21 is thus at least substantially equal to zero. In principle, this could also be different in a modified embodiment.
    Also in Fig. 1, which refers to the release state of the hinge part 1, the expansion chamber 21 is shown completely folded, so with a volume of substantially equal to zero. This is the case when the auxiliary fluid is under a lower pressure than the working fluid and / or when the auxiliary fluid is displaced out of the expansion chamber 21 due to the elasticity of the expansion body 20 when the pressure (the auxiliary fluid and the working fluid) is equal.
    Also, a certain residual volume of the expansion chamber 21 in the release state may be present.
    If the pressure inside the body (= internal body pressure) increases, e.g. due to a coughing fit, a force caused by the internal body pressure acts directly on the auxiliary fluid reservoir 22. When a force is applied to the auxiliary fluid reservoir 22, the pressure of the auxiliary fluid increases accordingly. If the internal body pressure, and thus the pressure of the auxiliary fluid, greater than the pressure of the working fluid, the auxiliary fluid reservoir 22 is compressed and auxiliary fluid is displaced from the storage chamber 23 into the expansion chamber 21. If the expansion body 20 of the expansion of the expansion chamber 21 opposes an elastic restoring force, this can also be overcome by the pressure of the auxiliary fluid (The expansion body 20 is thus expanded only when the ambient pressure exceeds the pressure of the working fluid so far that the elastic restoring force through the pressure of the auxiliary fluid is overcome). The resulting increase in the volume of the expansion chamber 21 leads to an increase in the pressure in the interior 12 of the pumping part 11. In this case, working fluid is expelled from the inner space 12 and introduced into the hollow chamber 3 of the hinge part 1. The inner portion 1a of the band member 1 is displaced in the direction of the longitudinal central axis 5 and thereby applied an additional force on the guided through the passage opening 4 body tissue 2. This state of the band member 1 is referred to in this document as the stress state of the band member 1 and is shown in Fig. 3.
    As a result, the internal body pressure and thus the pressure of the auxiliary fluid decreases again, so that the pressure of the auxiliary fluid is less than the pressure of the working fluid (optionally plus the elastic restoring force of the expansion body), the volume of the storage chamber 23 of the auxiliary fluid container 22 increases under absorption of discharged from the expansion chamber 21 of the expansion body 20 auxiliary fluid. After the stress event, the band part 1 is thus again in the shut-off state, cf. Fig. 2.
    If the body channel, starting from the shut-off state of the band member 1, e.g. for discharging urine, to be opened, i. the band member 1 by displacing working fluid from the hollow chamber 3 in the interior 12 of the pumping part 11 assumes the release state (see Fig. 1) and also no stress event exists, the volume of the expansion chamber 21 is substantially equal to zero or relatively low. Thus, when adjusting the band member 1 from the shut-off state to the release state (and vice versa), no or little auxiliary fluid must be delivered from the expansion chamber 21 into the storage chamber 23 of the auxiliary fluid container 22. The amount of working fluid to be displaced can thereby be minimized and the associated energy expenditure for displacing working fluid can be reduced. The interval for charging or replacing the battery of the control electronics 17 can be extended.
    FIGS. 8 and 9 show a second embodiment of a medical device according to the invention. The structure of the pump unit 10 and the auxiliary fluid container 22 corresponds to that of the first embodiment, so that in the explanations to the second embodiment mainly to the
    Differences to the first embodiment is pointed out. Apart from the differences mentioned below, the explanations on the first embodiment also apply in the second embodiment. Thus, with regard to the embodiment of the closure parts 6, 7 of the hinge part 1 shown only schematically in FIGS. 8 and 9, reference is also made to the explanations for the first exemplary embodiment.
    In the medical device according to the second exemplary embodiment, provision is made for the expansion body 20 to be arranged on the band part 1 on one side of the band part 1 facing the passage opening 4, that is to say on the inner portion 1a. This is shown schematically in FIGS. 8 and 9, wherein the expansion chamber 21 extends in the direction of the longitudinal extension of the hinge part 1, substantially over the entire length of the hinge part 1. The expansion body 20 is therefore formed like a tube in the second embodiment, with closed on both sides End up.
    In the closed state of the band part 1, the expansion body 20 arranged on the band part 1 has, relative to the circumferential direction of the longitudinal central axis 5, a substantially circumferential contact surface 20a for bearing against the body tissue 2.
    In the shut-off state of the closed hinge part 1, the hollow chamber 3 is filled with such an amount of working fluid that the body passage is closed, see. Fig. 8.
    When working fluid is discharged, the band member 1 occupies the not-shown release state in which the body passage is opened.
    If the pressure inside the body (= internal body pressure) rises starting from the shut-off state of the band part 1 shown in FIG. 8 in the presence of a stress event, then this internal body pressure acts on the auxiliary fluid container 22 analogously to the first exemplary embodiment. Is the body internal pressure, and thus the pressure of the
    Auxiliary fluid, greater than the force exerted by the body tissue 2 back pressure on the expansion body 20, the auxiliary fluid reservoir 22 is compressed and auxiliary fluid from the storage chamber 23 in the expansion chamber 21 of the expansion body 20 passed. If the expansion body 20 opposes the expansion of the expansion chamber 21 an elastic restoring force, this can also be overcome by the pressure of the auxiliary fluid. By enlarging the volume of the expansion chamber 21, the expansion body 20 directly compresses the body tissue 2 surrounding the body passage in order to ensure a reliable shut-off of the body passage during a stress event, cf. the stress state of the band member 1 shown in Fig. 9, in which an additional force is applied to the guided through the passage opening 4 body tissue 2. The body tissue 2 itself is not shown in FIGS. 8 and 9.
    If the body pressure returns to a ground state, i. without a stress event, the auxiliary fluid in turn flows back from the expansion chamber 21 into the auxiliary fluid reservoir 22, cf. the shut-off state of the band part 1 shown in Fig. 8.
    In the second embodiment, the backflow of the auxiliary fluid into the auxiliary fluid container 22 is thus effected by the action of the counter pressure exerted by the body tissue 2 together with the pressure exerted on the expansion body 20 by the hollow chamber 3 filled with working fluid. If the expansion body 20 opposes the expansion of the expansion chamber 21, an elastic restoring force, this can assist in the backflow of the auxiliary fluid.
    In the second embodiment can be provided that the expansion body 20 and the band member 1 are formed materialeinstückig. Conveniently, it is provided that the expansion body 20 is formed elastically stretchable in the second embodiment. In another embodiment, however, it could also be provided that the expansion body 20 is substantially inextensible and / or pliable.
    The band member 1 and / or the expansion body 20 in the second embodiment could be made of a biocompatible material, e.g. made of silicone.
    In the second embodiment, a non-illustrated connection piece for connecting the band part 1 with the auxiliary fluid line 24 is formed on the closure part 7. The interior of the connection piece communicates with the expansion chamber 21 via a channel running through the closure part 7. Such a connecting piece could also be provided at another point of the expansion body 20 or the band part 1.
    FIGS. 10 and 11 show a variant of the band part 1 according to the second exemplary embodiment, with particular emphasis on the differences from the band part 1 shown in FIGS. 8 and 9.
    10 and 11, the expansion body 20 extends in the direction of the longitudinal extension of the hinge part 1 over approximately half the length of the hinge part 1. The passage opening 4 is in the shut-off state of the hinge part 1 shown in FIG in contrast to the second embodiment, not circular. The contact surface 20a of the expansion body 20 extends in the closed state of the hinge part 1 with respect to a circumferential direction, starting from the longitudinal central axis 5 over 180 ° of the circumference of the passage opening 4th
    Otherwise, the band member 1 behaves according to the modification shown in FIGS. 10 and 11 when a stress event occurs analogous to the band member 1 of the second embodiment of the medical device, for which reason reference is made to the corresponding explanations to the second embodiment.
    Apart from the pump unit shown in the embodiments, the medical device could in principle also be used in combination with a well-known in the prior art, for example, manually operable,
    Pump unit can be used.
    Legend to the reference numbers: 1 band part 1a inner section 1b back section 2 body tissue 3 hollow chamber 4 passage opening 5 longitudinal center axis 6 first closure part 6a insertion 7 second closure part 7a tongue 8 connecting piece 9 working fluid line 10 pump unit 11 pumping part 12 interior 13 bottom part 14 actuator 15 drive 16 gear 17 control electronics 18 Port 19 housing 20 expansion body 20a abutment surface 21 expansion chamber 22 auxiliary fluid reservoir 23 storage chamber 24 auxiliary fluid line
    权利要求:
    Claims (10)
    [1]
    claims
    1. A medical device for shutting off a body passage, comprising a band part (1) which can be placed around the body tissue surrounding the body channel (2) and to a passage opening (4) for the body tissue (2) enclosing ring is closable and a hollow chamber (3), which is part of a receiving space of the device for receiving working fluid, and a pump unit (10) for conveying the working fluid, wherein by introducing the working fluid into the hollow chamber (3) the passage opening (4) is reduced, characterized in that the device further comprises an expansion body (20) with an expansion chamber (21), wherein the expansion body (20) in the receiving space for the working fluid or on one of the passage opening (4) facing side of the hinge part (1) on the band part (1) and expanding the expansion chamber (21) by introducing an auxiliary fluid separated from the working fluid into the expansion chamber (21) is Erbar.
    [2]
    2. Medical device according to claim 1, characterized in that the device has an auxiliary fluid container (22) with a storage chamber (23) for the auxiliary fluid whose volume is variable in dependence on an ambient pressure, and the auxiliary fluid container (22) via an auxiliary fluid line ( 24) is connected to the expansion chamber (21).
    [3]
    3. Medical device according to claim 2, characterized in that the auxiliary fluid container (22) has a storage chamber (23) bounding flexible wall.
    [4]
    A medical device according to claim 3, characterized in that the wall is substantially inextensible.
    [5]
    5. Medical device according to claim 3 or 4, characterized in that the wall is limp.
    [6]
    6. Medical device according to one of claims 1 to 5, characterized in that the pump unit (10) has a pump part (11) having an interior space (12) for receiving working fluid, wherein the volume of the interior space (12) a drive (15) is variable.
    [7]
    7. Medical device according to claim 6, characterized in that arranged in the receiving space expansion body (20) in the interior (12) of the pumping part (11) is arranged.
    [8]
    8. Medical device according to one of claims 1 to 6, characterized in that the band part (1) arranged expansion body (20) has a contact surface (20a) for engagement with the body tissue (2).
    [9]
    9. Medical device according to one of claims 1 to 8, characterized in that the volume of the expansion chamber (21) at a substantially compared to the pressure of the auxiliary fluid at a higher pressure working fluid is at least substantially equal to zero.
    [10]
    10. Medical device according to one of claims 2 to 9, characterized in that the pressure of the auxiliary fluid when exerting a force on the auxiliary fluid reservoir (22) increases.
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    同族专利:
    公开号 | 公开日
    US20200315764A1|2020-10-08|
    CN109310491B|2021-10-15|
    US11129700B2|2021-09-28|
    WO2017214643A1|2017-12-21|
    EP3468503A1|2019-04-17|
    AT518411B1|2017-10-15|
    CN109310491A|2019-02-05|
    BR112018075669A2|2019-04-09|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    ATA294/2016A|AT518411B1|2016-06-14|2016-06-14|Medical device for shutting off a body canal|ATA294/2016A| AT518411B1|2016-06-14|2016-06-14|Medical device for shutting off a body canal|
    BR112018075669A| BR112018075669A2|2016-06-14|2017-05-12|medical equipment for the isolation of a body canal|
    EP17728038.5A| EP3468503A1|2016-06-14|2017-05-12|Medical arrangement for shutting off a body channel|
    CN201780037350.7A| CN109310491B|2016-06-14|2017-05-12|Medical device for blocking a body passage|
    US16/305,207| US11129700B2|2016-06-14|2017-05-12|Medical arrangement for shutting off a body channel|
    PCT/AT2017/000036| WO2017214643A1|2016-06-14|2017-05-12|Medical arrangement for shutting off a body channel|
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