• 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 ligament part (1) which can be laid around the body tissue (2) surrounding the body canal and can be closed to form a ring (4) enclosing a body tissue (2) and which is a hollow chamber ( 3), which constitutes part of a working fluid 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. Furthermore, the device comprises a storage container (22) with a flexible wall (22a) delimiting a storage chamber (23), the volume of the storage chamber (23) passing through an additional force on the body tissue (2) guided through the passage opening (4) Increase an acting on the storage container (22) ambient pressure is reduced, wherein the wall (22 a) of the storage container (22) is at least substantially inextensible. (Fig. 3)
    公开号:AT518764A1
    申请号:T293/2016
    申请日:2016-06-14
    公开日:2017-12-15
    发明作者:Martin Hohlrieder Dr
    申请人:Ami Agency Medical Innovations Gmbh；
    IPC主号:
    专利说明:

    The present invention relates to a medical device for shutting off a body passage, comprising a band member which is layable around the body tissue surrounding the body passage and closable to a body tissue surrounding passage opening and which has a hollow chamber forming part of a working fluid accommodating space represents the 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, and a storage container with a storage chamber bounding flexible wall, wherein for applying an additional force on the through the passage opening Guided body tissue, the volume of the storage chamber can be reduced by increasing an ambient pressure acting on the storage container.
    Medical devices for shutting off a body passage are used, inter alia, as artificial (closing) muscles for assisting or replacing 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 applications are z. B. 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 a subsequent automatic closure of the body passage by pumping back of working fluid (possibly via a throttle valve) in the hollow chamber of the hinge part. A pump unit for pumping working fluid is usually implanted in the scrotum in such an artificial urinary sphincter in male patients. The pumping of working fluid from the hollow chamber can then be done by pressure on a flexible part of the pump unit. The pumping back of working fluid in the hollow chamber can be done by a resilient element of the pumping unit. 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 unit.
    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. The pressure of the working fluid in the hollow chamber is therefore usually chosen so that the erosion of body tissue can be kept as low as possible and at the same time a reliable shut-off of the body passage is achieved.
    At a tension of the abdominal muscles, as z. B. 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 abdomen arranged inside (hollow) organs, z. B. 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 the inner portion of the cuff in the direction of the longitudinal center axis caused thereby closes off the body passage. Between two sections of a working fluid line, which fluidly connects a pump to the cuff, there is a storage container in the form of a flexible balloon (= "stress balloon") made of elastically stretchable silicone The storage chamber formed by the stress balloon is filled with working fluid By briefly increasing the pressure of the working fluid, the body passage can be shut off and a leak prevented even during a stress event, and then the internal pressure of the body decreases again, which increases the volume of the pressure inside the buffer The volume of the storage chamber of the stress balloon and the pressure of the working fluid decrease, with working fluid flowing out of the cuff, and increasing the pressure of the working fluid in the cuff to close the body passage also increases the volume of the stre ssballons, so that by means of the pump a correspondingly large amount of liquid 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.
    In the medical device according to the invention it is provided that the wall of the storage container is at least substantially inextensible.
    When filling the storage container so at least substantially no material expansion of the wall, d. H. the volume of the storage chamber can be increased at least substantially only by unfolding the flexible wall. The volume of the storage chamber is thus limited to a maximum storage volume of the storage chamber.
    Forming a wall as flexible means that it is bendable, in particular collapsible.
    The storage container can be implanted in the body, in particular in the abdomen, wherein the body internal pressure acting on the body acts on the storage container. When tensing abdominal muscles during a stress event, the volume of the storage chamber of the storage container changes due to an increase in ambient pressure (= internal body pressure). During a stress event, the ambient pressure acting on the storage tank is above the atmospheric pressure.
    The term "substantially inextensible" refers to the material property of the wall of the storage container in which the volume of the storage chamber remains substantially unchanged from a maximally deployed state with an increase in pressure in the storage chamber during operation of the device During operation of the medical device, it is preferably provided that the volume of the storage chamber is reduced by less than 10%, preferably by less than 5, from a maximum unfolded state of the storage container when the pressure in the storage chamber is increased by 0.1 bar %, increases.
    The wall of the storage container may have an at least substantially inextensible reinforcement. The reinforcement can e.g. be formed net-like. Conveniently, the reinforcement has a modulus of elasticity of at least 1000 N / mm 2, preferably of at least 5000 N / mm 2. The wall can, for example, have a matrix of silicone, in which the reinforcement is embedded.
    Alternatively, or in addition to such an at least substantially inextensible reinforcement, the wall of the storage container may comprise or consist of a layer of at least substantially ineluctable plastic film. The
    Plastic film could z. B. made of polyethylene, polyamide or the like. The elastic modulus of the plastic film is preferably at least 1000 N / mm 2, more preferably at least 5000 N / mm 2. In particular, when using a wall made of a plastic film may be provided that the wall is formed slippery. Ie. that the wall does not return to an earlier form by itself (= without external force). The pliable wall could also be called form-labile.
    In a first possible embodiment of the invention it is provided that the storage chamber forms a part of the working fluid receiving space, wherein the pressure of the working fluid can be increased by reducing the volume of the storage chamber for applying the additional force. If the pressure acting on the storage chamber from the outside, ie the ambient pressure (= internal body pressure) rises to a sufficiently high value (via the pressure of the working fluid) during a stress event, the pressure of the working fluid is increased by reducing the volume of the storage chamber. Thus, the pressure (= pressure of the working fluid) in the hollow chamber of the band part increases accordingly, whereby an additional force can be exerted on the body tissue. Decreases in the sequence of the body internal pressure and thus the pressure of the working fluid again, so the volume of the storage chamber of the storage container increases by receiving working fluid, in particular up to the maximum storage volume of the storage chamber.
    The storage container may be arranged in this embodiment, for example, between two portions of the working fluid line, which connects the hollow chamber of the band part with the pump unit. On the other hand, it can also be provided that the storage container is connected via a separate connecting line with the pump unit.
    In a second possible embodiment of the invention it is provided that the storage chamber forms part of an auxiliary fluid receiving space of the device for receiving an auxiliary fluid separated from the working fluid and the auxiliary fluid receiving space further comprises an expansion chamber of an expansion body of the device.
    The auxiliary fluid is completely separated from the working fluid, i. H. that no fluid exchange takes place between the auxiliary fluid and the working fluid.
    When a stress event occurs, e.g. B. caused by an increase in the internal body pressure in a coughing fit, by increasing the volume of the storage chamber by a sufficiently large pressure acting from the outside on the storage tank, an enlargement of the expansion chamber of the expansion body. 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. For this purpose, 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.
    In a first possible variant of this second embodiment of the invention it is provided that the expansion body is arranged in the working fluid receiving space. 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. The expansion body could for example be arranged in the hollow chamber of the band part or the working fluid line. Particularly preferably, the expansion body is arranged in the pump unit.
    In a second possible variant of this second embodiment of the invention, the expansion body is arranged at one of the passage opening facing side of the band part on the band part, ie at the inner portion of the band portion. Filling the expansion chamber with auxiliary fluid causes an enlargement of the
    Volume of the expansion chamber, which acts directly compressing the tissue surrounding the body passage. This can be a reliable one
    Shut off the body passage during a stress event to be ensured.
    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 first exemplary embodiment of a medical device designed as an artificial urethra sphincter, in a release state of the strap part in which the ureter is open;
    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 sectional views of the storage container according to FIGS. 2 and 3;
    Fig. 6 and 7 oblique views of the free, so not implanted, band part of
    Device in an open and closed state, according to the release state;
    Fig. 8 is a longitudinal center section (parallel to the longitudinal center axis of
    Through opening and passing through) by the band part in the state shown in FIG. 7;
    FIG. 9 shows a longitudinal center section analogous to FIG. 8, but in the shut-off state of the band part; FIG.
    10 shows a schematic representation of a second embodiment according to the invention of an artificial urethral sphincter in a shut-off state of the band part in which the ureter is closed;
    11 is a view analogous to FIG. 10 in a stress state of the strap part in which an additional force is exerted on the ureter; FIG.
    FIGS. 12 and 13 are schematic representations of a third embodiment according to the invention analogous to FIGS. 10 and 11, and FIGS. 14 and 15 are schematic representations of a fourth according to the invention
    Embodiment in a shut-off state and a stress state of the band part.
    A band part 1 of the medical device is annular around the bodily tissue surrounding the body 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, cf. Fig. 6.
    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. 7. 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. 8 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). 9 shows a state filled with the working fluid, in particular the state filled to the maximum with working fluid (the pressure of the working fluid in the hollow chamber 3 being above the ambient pressure). In Fig. 9 are wrinkles, as they would arise in particular, if the band part is not placed around the ureter, not shown. A remote from the longitudinal center axis 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 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 replaceable.
    In the exemplary embodiment, a connecting piece 8 is integrally formed on one of the closure parts, the cavity of which communicates with the hollow chamber 3 via a channel running through the closure part 7. 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 channel passing through the closure part 7 and the hollow chamber 3 each form part of a working fluid receiving space for receiving working fluid. The working fluid receiving space of the medical device comprises the entire contiguous internal cavity of the device in which working fluid is in operation. Also, the inner channel of the working fluid line 9 and a filled during operation of the device with working fluid interior 12 of a pumping part 11 each form part of the working fluid-receiving space for the working fluid. The band part 1 is connected via the working fluid line 9 with the locally separated from the band part 1 pump part 11 of the 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.
    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.
    A port 18 is conventionally provided for filling the working fluid receiving space of the medical device with working fluid. This can be connected for example via a hose to the pump part 11.
    The medical device furthermore has a storage container 22 with a storage chamber 23.
    In the first exemplary embodiment, the storage container 22 is arranged between two sections 9 ', 9 "of the working fluid line 9, which connects the hollow chamber 3 of the hinge part 1 to the interior 12 of the pumping part 11. During operation of the device, the storage chamber 23 is filled with working fluid and forms thus part of the working fluid receiving space of the device.
    The storage chamber 23 of the storage container 22 is bounded by a flexible wall 22a. This is at least substantially inextensible. That is, the volume of the storage chamber 23 during operation of the device, starting from a maximum unfolded state of the storage container 22 with an increase in the pressure in the storage chamber 23, at least substantially not increased. In the first embodiment, the pressure in the corresponds
    Storage chamber 23 the pressure of the working fluid.
    An increase in the pressure in the storage chamber 23 (= pressure of the working fluid) of the maximally unfolded storage container 22 by 0.1 bar (based on the pressure present in the shut-off state of the band member 1) leads in the embodiment at most to an increase in the volume of the storage chamber 23 by less than 5%.
    The wall 22a of the storage container 22 has an at least substantially inextensible reinforcement 22b. The reinforcement 22b favorably has a modulus of elasticity of at least 1000 N / mm 2, preferably of at least 5000 N / mm 2. The reinforcement 22b is embedded in a base material (= matrix) of the wall 22a, cf. Fig. 4 and 5. In the embodiment, the base material made of silicone.
    The reinforcement 22b is formed like a net, i. that individual fibers or strands of the reinforcement are joined at intersection points forming rectangular or diamond-shaped meshes of the reinforcement 22b. The reticulated reinforcement 22b could also be referred to as a braid.
    The storage container 22 is collapsible, wherein the volume of the storage chamber 23 can be changed by folding or unfolding of the storage container 22, cf. FIGS. 4 and 5. A folding can be effected, in particular, by an increase in the ambient pressure (= internal body pressure) to a pressure above the pressure of the working fluid.
    The wall 22a of the storage container 22 could alternatively or in addition to the reinforcement 22b have an at least substantially ineluctable plastic film or be formed by an at least substantially inextensible plastic film. In an embodiment of the wall 22a of a plastic film could be provided that the wall is formed pliable, i. the wall 22a then does not automatically return to an earlier shape. The limp formed wall 22a could also be referred to as a form labile. Conveniently, the plastic film has a modulus of elasticity of at least 1,000 N / mm 2, preferably of at least 5,000 N / mm 2.
    The plastic film could e.g. be formed of polyethylene or polyamide.
    In the released state shown in FIG. 1 and in the shut-off state of the band member 1 shown in FIG. 2, the volume of the storage chamber 23 corresponds to a maximum value of the volume (= storage volume). The volume of the storage chamber 23 thus does not change between the release state and the shut-off state of the band part 1 (as long as there is no external pressure on the storage container 22, see the description below). However, it could also be provided that the volume of the storage chamber 23 in the release state of the band member 1 is smaller than the maximum storage volume of the storage chamber 23, i. that the storage container 22 is then not fully unfolded.
    If the pressure inside the body (= internal body pressure) increases, e.g. due to a coughing fit, so caused by the internal body pressure force acts directly on the storage container 22 a. If the body internal pressure is greater than the pressure of the working fluid in the shut-off state of the band member 1, the storage container 22 is compressed. This increases the pressure of the working fluid, wherein additionally working fluid is introduced into the hollow chamber 3 of the band part 1. The inner portion 1a of the hinge part 1 is displaced in the direction of the longitudinal central axis and thereby an additional force applied to 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.
    Decreases in the sequence of the body internal pressure and thus the pressure of the working fluid, the volume of the storage chamber 23 of the storage container 22 increases to accommodate working fluid. After the stress event, the band part 1 is thus again in the shut-off state, cf. Fig. 2.
    Since the wall 22a of the storage container 22 is at least substantially inextensible, the storage container 22 exerts at least substantially no elastic restoring force on the contents of the storage chamber when the storage chamber 23 is filled (starting from a collapsed state of the storage container 22). which is working fluid in the first embodiment, from. If the body channel, starting from the shut-off state of the band member 1, e.g. for discharging urine, to be opened, i. When the band member 1 assumes the release state (see, for example, Fig. 1) by displacing working fluid from the hollow chamber 3 into the inner space 12 of the pumping member 11 and there is no stress event, the volume change of the storage chamber 23 remains substantially zero or relatively low. When adjusting the band part 1 from the shut-off state into the release state and vice versa, no or only little working fluid has to be conveyed out of and into the storage 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. 10 and 11 show a second embodiment of a medical device according to the invention. The structure of the pumping unit 10 and the band member 1 corresponds to that of the first embodiment, so that in the explanations to the second embodiment mainly referred to the differences from the first embodiment. Apart from the differences mentioned below, the explanations on the first exemplary embodiment also apply to the second exemplary embodiment. So u.a. with regard to the formation of the wall 22a of the storage container 22 and with regard to the closure parts 6, 7 of the hinge part 1 shown only schematically in FIGS. 10 and 11, reference is made to the explanations for the first exemplary embodiment.
    In the medical device according to the second embodiment, it is provided that the storage container 22 is connected to the pump unit 10 via a separate connection line 25. The storage chamber 23 of the storage container 22 forms part of the working fluid receiving space of the device in the second embodiment. In contrast to the first embodiment, the storage container 22 has only one connection for working fluid and is otherwise formed, preferably completely, closed. During a stress event, there is thus a displacement of working fluid from the storage chamber 23 via the inner channel of the connecting line 25 into the inner space 12 of the pumping part 11. The connecting line 25 is designed as a hose.
    Otherwise, the medical device according to the second embodiment behaves analogously to the device according to the first exemplary embodiment of the medical device when a stress event occurs, for which reason reference is made to the corresponding explanations for the first exemplary embodiment.
    FIGS. 12 and 13 show a third exemplary embodiment of a medical device according to the invention. The structure of the pump unit 10 and the band member 1 corresponds to those of the first and second embodiments. The structure of the storage container 22 corresponds to that of the second embodiment, so that in the explanations of the third embodiment is mainly referred to the differences from the first or second embodiment. Apart from the differences listed below, the explanations on the first and second embodiments thus also apply to the third embodiment.
    In the medical device according to the third embodiment, it is provided that the storage chamber 23 of the auxiliary fluid container 22 is fluid-conductively connected by means of an auxiliary fluid line 24 to an expansion chamber 21 of an expansion body 20. 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 storage chamber 23 in this embodiment thus forms part of an auxiliary fluid receiving space of the means for receiving an auxiliary fluid separated from the working fluid. Also, the expansion chamber and the inner channel of the auxiliary fluid line 24 form part of the auxiliary fluid receiving space of the device.
    In the third exemplary embodiment, the expansion body 20 is arranged in the working fluid receiving space of the device filled with working fluid, namely in the interior 12 of the pump part 11, cf. Figs. 12 and 13. the expansion body 20 is surrounded by working fluid.
    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 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 designed as a limp, the expansion body 20 is then formlabil, as indicated in Fig. 12.
    At least in the shut-off state of the band member 1 shown in Fig. 12, the auxiliary fluid is under a lower pressure than the working fluid. The expansion chamber 21 of the expansion body is preferably completely folded. Thus, at least substantially no auxiliary fluid is in the expansion chamber 21. 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.
    Even in the release state of the band member 1, not shown, the expansion chamber 21 could be completely folded, that is, 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.
    Now increases the pressure inside the body (= internal body pressure), for example, in a coughing fit, so caused by the internal body pressure force acts directly on the storage container 22 a. When a force is applied to the storage container 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 storage container 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 interior 12 and introduced into the hollow chamber 3 of the band portion. The inner portion 1 a of the hinge part 1 is thus displaced in the direction of the longitudinal central axis 5 and thereby applied the additional force to the guided through the passage opening 4 body tissue 2. This state of the band part 1 (= stress state) is shown in FIG.
    Decreases in the sequence of body pressure and thus the pressure of the
    Auxiliary fluid again, so that the pressure of the auxiliary fluid is smaller than the pressure of the working fluid (optionally plus the elastic restoring force of the expansion body 20), so the volume of the storage chamber 23 of the storage container 22 increases by receiving from the expansion chamber 21 of the expansion body 20 discharged auxiliary fluid. After the stress event, the band part 1 is again in the shut-off state, cf. Fig. 12.
    FIGS. 14 and 15 show a fourth exemplary embodiment of a medical device according to the invention. The structure of the pump unit 10 and the storage container 22 corresponds to that of the preceding embodiments. In the explanation of the fourth embodiment, reference is made here mainly to the differences from the third embodiment. Apart from the differences mentioned below, the explanations regarding the third exemplary embodiment also apply to the fourth exemplary embodiment.
    In the medical device according to the fourth 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. 14 and 15, wherein the expansion chamber 21 extends in the direction of the longitudinal extent of the band part 1, substantially over the entire length of the band part 1. The expansion body 20 is thus formed like a tube in the fourth 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. 14. The pressure of the working fluid corresponds to the counterpressure exerted by the body tissue plus an optionally restoring elastic restoring force of the band part 1.
    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) increases starting from the shut-off state of the band part 1 shown in FIG. 14 in the event of a stress event, this internal body pressure acts on the storage container 22. If the internal body pressure, and thus the pressure of the auxiliary fluid, greater than the pressure exerted by the body tissue back pressure on the expansion body 20, the storage container 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 of the expansion of the expansion chamber 21 opposes an elastic restoring force, this is also 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 surrounding the body passage 2 in order to ensure a reliable shut-off of the body passage during a stress event, cf. the stress state of the band part 1 shown in Fig. 15, 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. 14 and 15.
    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. 14.
    The backflow of the auxiliary fluid into the storage container 22 is thus effected by the action of the force exerted by the body tissue 2 back pressure together with the force exerted by the working fluid filled with hollow chamber 3 on the expansion body 20 pressure. 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 fourth embodiment it 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 another embodiment, however, it could also be provided that the expansion body 20 is substantially inextensible and / or pliable.
    Apart from the pumping unit shown in the embodiments, the storage container could in principle also be used in combination with a well-known in the prior art, for example, manually operable pumping unit.
    Key to the reference numbers: 1 hinge part 20 expansion body 1a inner section 2 ^ a contact surface 1b back section 21 expansion chamber 2 body tissue 22 storage container 3 hollow chamber 22a wall 4 passage opening 22d reinforcement 5 longitudinal central axis 23 storage chamber 6 first closure part 2 ^ auxiliary fluid line 6a insertion opening 25 connecting line 7 second closure part 7a tongue 8 connecting piece 9 working fluid line 9 ', 9 "section of the working fluid line 10 pumping unit 11 pumping part 12 interior 13 bottom part 14 adjusting element 15 drive 16 gear 17 control electronics 18 port 19 housing
    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 a part of a working fluid 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, and a storage container (22) having a storage chamber (23) defining a flexible wall (22a), wherein for applying an additional force on the guided through the passage opening (4) body tissue (2), the volume of the storage chamber (23) by an increase of a The ambient pressure acting on the storage container (22) can be reduced, characterized in that the wall (22a) of the storage container (22) is at least substantially formed undeformable.
    [2]
    2. A medical device according to claim 1, characterized in that the storage chamber (23) forms part of an auxiliary fluid receiving space of the device for receiving an auxiliary fluid separated from the working fluid and the auxiliary fluid receiving space further comprises an expansion chamber (21) of an expansion body (20) Device comprises, wherein the expansion chamber (21) for applying the additional force with the auxiliary fluid can be filled.
    [3]
    3. Medical device according to claim 2, characterized in that the expansion body (20) is arranged in the working fluid receiving space.
    [4]
    4. Medical device according to claim 2, characterized in that the expansion body (20) at one of the passage opening (4) facing side of the band part (1) on the band part (1) is arranged.
    [5]
    5. Medical device according to claim 1, characterized in that the storage chamber (23) constitutes a part of the working fluid receiving space and the pressure of the working fluid by reducing the volume of the storage chamber (23) for applying the additional force can be increased.
    [6]
    6. Medical device according to claim 5, characterized in that the hollow chamber (3) of the band part (1) by means of a working fluid line (9) with the pump unit (10) is connected, wherein the storage container (22) between two sections of the working fluid line (9 ) is arranged.
    [7]
    7. Medical device according to claim 5, characterized in that the hollow chamber (3) of the band part (1) by means of a working fluid line with the pump unit (10) is connected, and the storage container (22) via a separate connecting line (25) with the pump unit (10) is connected.
    [8]
    8. Medical device according to one of claims 1 to 7, characterized in that the volume of the storage chamber (23), starting from a maximum unfolded state of the storage container (22) at an increase in the pressure in the storage chamber (23) by 0 , 1 bar increases by less than 10%, preferably by less than 5%.
    [9]
    9. Medical device according to one of claims 1 to 8, characterized in that the wall (22a) of the storage container (22) has an at least substantially inextensible reinforcement.
    [10]
    10. Medical device according to one of claims 1 to 9, characterized in that the wall (22a) of the storage container (22) comprises a layer of an at least substantially undeformable plastic film or consists thereof.
    类似技术:
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    EP3468504B1|2020-07-08|Medical arrangement for shutting off a body channel
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    EP0301292B1|1991-12-11|Closure for a male urethra
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    DE3048591A1|1981-10-01|PENIS PROSTHESIS
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    WO2017205883A1|2017-12-07|Medical device for narrowing or closing an anatomical channel
    AT518411B1|2017-10-15|Medical device for shutting off a body canal
    DE19831698C2|2000-08-31|Check valve, in particular for an implantable artificial bladder
    DE19903246B4|2005-11-24|Erection device for a human penis
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    WO2021213834A1|2021-10-28|Method for adjusting a fill level of a liquid balloon of a medical device, and medical device comprising a liquid balloon for forming artificial sphincters
    DE8331338U1|1984-02-09|Device for the optional opening and closing of tubular body organs, in particular the urethra
    同族专利:
    公开号 | 公开日
    CN109310490B|2021-12-10|
    CN109310490A|2019-02-05|
    US11207163B2|2021-12-28|
    BR112018075671A2|2019-04-09|
    WO2017214644A8|2018-04-26|
    EP3468504B1|2020-07-08|
    AT518764B1|2018-03-15|
    ES2820752T3|2021-04-22|
    WO2017214644A1|2017-12-21|
    US20200315763A1|2020-10-08|
    EP3468504A1|2019-04-17|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    ATA293/2016A|AT518764B1|2016-06-14|2016-06-14|Medical device for shutting off a body canal|ATA293/2016A| AT518764B1|2016-06-14|2016-06-14|Medical device for shutting off a body canal|
    EP17734971.9A| EP3468504B1|2016-06-14|2017-06-01|Medical arrangement for shutting off a body channel|
    US16/303,379| US11207163B2|2016-06-14|2017-06-01|Medical arrangement for shutting off a body channel|
    BR112018075671-7A| BR112018075671A2|2016-06-14|2017-06-01|medical equipment for the isolation of a body canal|
    CN201780037222.2A| CN109310490B|2016-06-14|2017-06-01|Medical device for blocking a body passage|
    ES17734971T| ES2820752T3|2016-06-14|2017-06-01|Medical device to close a channel of the body|
    PCT/AT2017/000046| WO2017214644A1|2016-06-14|2017-06-01|Medical arrangement for shutting off a body channel|
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