Medical arrangement for shutting off a body channel
11207163 · 2021-12-28
Assignee
Inventors
Cpc classification
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
A medical device for shutting off a body channel is provided including a band section that can be placed around the body tissue surrounding a body channel and can be closed to form a ring enclosing a passage opening for the body tissue, and has a cavity which makes up one part of a working fluid receiving chamber of the device, for receiving working fluid, and a pump unit for conveying the working fluid. The passage opening is made smaller by introducing the working fluid into the cavity. The arrangement also includes a storage container that has a flexible wall which delimits a storage chamber, wherein to apply an additional force to the body tissue guided through the passage opening, the volume of the storage chamber is made smaller by increasing an ambient pressure acting on the storage container, and the wall of the storage container is at least substantially non-extensible.
Claims
1. A medical device for shutting off an anatomical channel, comprising a band part configured for placement around body tissue surrounding the anatomical channel and that is adapted to be closed to form a ring that encloses a through-opening for the body tissue, the band part including a hollow chamber constituting a part of a working fluid receiving space that is configured to receive working fluid, a pump unit configured to convey the working fluid into the hollow chamber, such that the through-opening is made smaller by introduction of the working fluid into the hollow chamber, a storage container with a flexible wall delimiting a storage chamber, a volume of the storage chamber is reducible by increasing an ambient pressure acting on the storage container in order to apply an additional force to the body tissue that is guided through the through opening, the wall of the storage container is configured to be non-extensible in that, starting from a state of maximum deployment of the storage container, the volume of the storage chamber increases by less than 10% for a 0.1 bar increase in pressure in the storage chamber.
2. The medical device as claimed in claim 1, wherein the storage chamber forms part of an auxiliary fluid receiving space that is adapted to receive an auxiliary fluid separate from the working fluid, and the auxiliary fluid receiving space further comprises an expansion chamber of an expansion body, and the expansion chamber is adapted to be filled with the auxiliary fluid in order to apply the additional force.
3. The medical device as claimed in claim 2, wherein the expansion body is arranged in the working fluid receiving space.
4. The medical device as claimed in claim 2, wherein the expansion body is arranged at the band part, on a side of the band part directed toward the through-opening.
5. The medical device as claimed in claim 1, wherein the storage chamber is part of the working fluid receiving space, and the pressure of the working fluid is increased by reducing the volume of the storage chamber in order to apply the additional force.
6. The medical device as claimed in claim 5, wherein the hollow chamber of the band part is connected to the pump unit by a working fluid line, and the storage container is arranged between two portions of the working fluid line.
7. The medical device as claimed in claim 5, wherein the hollow chamber of the band part is connected to the pump unit by a working fluid line, and the storage container is connected to the pump unit via a separate connection line.
8. The medical device as claimed in claim 1, wherein starting from the state of maximum deployment of the storage container, the volume of the storage chamber increases by less than 5% for a 0.1 bar increase in pressure in the storage chamber.
9. The medical device as claimed in claim 1, wherein the wall of the storage container has a an at least substantially non-extensible reinforcement.
10. The medical device as claimed in claim 1, wherein the wall of the storage container comprises a layer of a non-extensible plastic film.
11. The medical device as claimed in claim 10, wherein an elastic modulus of the plastic film is at least 1.0 N/mm.sup.2.
12. The medical device as claimed in claim 9, wherein the non-extensible reinforcement has an elastic modulus of at least 1.0 N/mm.sup.2.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Further advantages and details of the invention are explained below with reference to the attached drawings, in which:
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DETAILED DESCRIPTION
(13) A band part 1 of the medical device can be placed in a ring shape around the body tissue 2 surrounding the anatomical channel, here the urethra. The band part 1 has a hollow chamber 3 which extends in the direction of the longitudinal extent of the band part 1, in the illustrative embodiments substantially along the entire length of the band part 1. The band part 1 is thus configured like a hose, with ends closed at both sides.
(14) A first and a second closure part 6, 7 are arranged at the two ends of the band part 1. 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 locked therein (cf.
(15) The closure parts 6, 7 thus form a closure with which the band part 1 can be closed to form a ring, in particular a circular ring (cf.
(16) A working fluid, in particular a liquid, e.g. saline solution, is located in the hollow chamber 3. The size of the through-opening 4 depends on the quantity of the working fluid in the hollow chamber 3. The through-opening 4 can be made smaller by introducing working fluid into the hollow chamber 3. A flexible inner portion 1a of the band part 1, which portion is adjacent to the longitudinal center axis 5 of the through-opening 4, is displaced in the direction toward the longitudinal center axis 5, as is known. By removing working fluid from the hollow chamber 3, the through-opening 4 can be made larger again.
(17)
(18) In the closed state of the band part 1 placed around the anatomical channel, said band part 1 can thus adopt a release state, in which the anatomical channel is opened (cf.
(19) Various modifications of the design of the band part are conceivable and possible. For example, it would be possible for special closure parts mounted on the band part 1 to be omitted altogether and for the two ends of the band part to be sewn to each other.
(20) The band part 1 can be made from silicone in a known manner. Other biocompatible materials may also be used in principle.
(21) In the illustrative embodiment, an attachment stub 8 is integrally formed on one of the closure parts, the interior of which attachment stub 8 is connected to the hollow chamber 3 via a channel running through the closure part 7. Such an attachment stub could also be provided at another location of the band part. A working fluid line 9 configured as a hose is attached at the attachment stub 8.
(22) The channel, running through the closure part 7, and the hollow chamber 3 each form a part of a working fluid receiving space for receiving working fluid. The working fluid receiving space of the medical device comprises the entirety of the continuous interior of the device in which working fluid is located during operation. Moreover, the inner channel of the working fluid line 9 and an interior 12 of a pump part 11, filled with working fluid during the operation of the device, each form a part of the working fluid receiving space for the working fluid. The band part 1 is connected by the working fluid line 9 to the pump part 11 of the pump unit 10, which is spatially separate from the band part 1 (cf.
(23) In the illustrative embodiments, the pump part 11 is formed by a bellows which is closed by a bottom part 13 and a cover part, the latter constituting an actuating element 14. An electric drive 15 acts on the actuating element 14 via a gear 16, for example a worm gear, in order to change the volume of the interior 12. The gear 16 is expediently self-locking, such that an adopted position of the actuating element 14 is maintained without supply of electrical energy to the drive 15.
(24) In the illustrative embodiment, the pump part 11 thus forms at the same time a reservoir for the working fluid with which the hollow chamber 3 of the band part 1 is filled in order to close the anatomical channel. For example, the pump part 11 could also be formed by a piston-cylinder unit, in which case the actuating element 14 would be formed by the piston of this piston-cylinder unit.
(25) The electric drive 15 is controlled by a control electronics unit 17 of the pump unit 10, which also has a battery (not shown) for supplying electric current to the drive 15. The control electronics unit 17 is operated by the user via a suitable user interface (not shown). The user interface can be an operating unit that is linked to the control electronics unit 17 by wire or by radio and that has corresponding switches.
(26) The user interface can be arranged outside the body. Implantation of the user interface is conceivable and possible. A separate user interface could in principle also be omitted, in which case at least one operating element activatable by the user would be arranged at the pump unit 10. This would accordingly have to be able to be activated from outside the body.
(27) The components of the pump unit 10 are arranged in a housing 19. The housing 19 is made of a biocompatible material or is encased by such a material.
(28) To fill the working fluid receiving space of the medical device with working fluid, a port 18 is provided in the customary way. This port 18 can be attached to the pump part 11 via a hose, for example.
(29) The medical device moreover has a storage container 22 with a storage chamber 23.
(30) In the first illustrative embodiment, the storage container 22 is arranged between two portions 9′, 9″ of the working fluid line 9 which connects the hollow chamber 3 of the band part 1 to the interior 12 of the pump part 11. During the operation of the device, the storage chamber 23 is filled with working fluid and thus forms a part of the working fluid receiving space of the device.
(31) The storage chamber 23 of the storage container 22 is delimited by a flexible wall 22a. The latter is designed to be at least substantially non-extensible. That is to say, during the operation of the device, starting from a state of maximum deployment of the storage container 22, the volume of the storage chamber 23 does not substantially increase when the pressure in the storage chamber 23 rises. In the first illustrative embodiment, the pressure in the storage chamber 23 corresponds to the pressure of the working fluid.
(32) In the illustrative embodiment, an increase of the pressure in the storage chamber 23 (=pressure of the working fluid) of the maximally deployed storage container 22 by 0.1 bar (starting from the pressure present in the shut-off state of the band part 1) leads at most to an increase of the volume of the storage chamber 23 of less than 5%.
(33) The wall 22a of the storage container 22 has an at least substantially non-extensible reinforcement 22b. The reinforcement 22b expediently has an elastic modulus of at least 1,000 N/mm.sup.2, preferably of at least 5,000 N/mm.sup.2. The reinforcement 22b is embedded in a base material (=matrix) of the wall 22a (cf.
(34) The reinforcement 22b is configured like a net, i.e. individual fibers or strands of the reinforcement are joined at points of intersection form rectangular or diamond-shaped meshes of the reinforcement 22b. The net-like reinforcement 22b could also be designated as a braiding.
(35) The storage container 22 can fold up, wherein the volume of the storage chamber 23 can be changed through a folding up or unfolding of the storage container 22 (cf.
(36) As an alternative or addition to the reinforcement 22b, the wall 22a of the storage container 22 could have an at least substantially non-extensible plastic film or could be formed by an at least substantially non-extensible plastic film. In a design of the wall 22a from a plastic film 22a, provision could be made that the wall is designed to be pliable, i.e. the wall 22a does not then return spontaneously to an earlier shape. The pliable wall 22a could also be referred to as dimensionally unstable.
(37) The plastic film expediently has an elastic modulus of at least 1,000 N/mm.sup.2, preferably of at least 5,000 N/mm.sup.2.
(38) The plastic film could be of polyethylene or polyamide, for example.
(39) In the release state of the band part 1 as shown in
(40) If the pressure within the body (=internal body pressure) increases, e.g. because of a coughing fit, a force brought about by the internal body pressure acts directly on the storage container 22. If the internal body pressure is greater than the pressure of the working fluid in the shut-off state of the band part 1, then the storage container 22 is compressed. The pressure of the working fluid increases as a result, wherein working fluid is additionally introduced into the hollow chamber 3 of the band part 1. The inner portion 1a of the band part 1 is displaced in the direction toward the longitudinal center axis, and in this process an additional force is applied to the body tissue 2 guided through the through-opening 4. This state of the band part 1 is referred to in this document as the stress state of the band part 1 and is shown in
(41) As the internal body pressure, and therefore the pressure of the working fluid, subsequently decreases, the volume of the storage chamber 23 of the storage container 22 increases as it receives working fluid. After the stress event, the band part 1 is thus located again in the shut-off state (cf.
(42) Since the wall 22a of the storage container 22 is designed to be at least substantially non-extensible, this means that the storage container 22, during the filling of the storage chamber 23 and the increase of volume (starting from a folded-up state of the storage container 22), exerts substantially no elastic restoring force on the content of the storage chamber, which content, in the first illustrative embodiment, is working fluid. When the anatomical channel is to be opened from the shut-off state of the band part 1, e.g. to pass urine, i.e. when the band part 1 adopts the release state (see
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(44) In the medical device according to the second illustrative embodiment, provision is made that the storage container 22 is connected to the pump unit 10 via a separate connection line 25. In the second illustrative embodiment too, the storage chamber 23 of the storage container 22 forms a part of the working fluid receiving space of the device. In contrast to the first illustrative embodiment, the storage container 22 has only one attachment for working fluid and is otherwise closed, preferably completely. During a stress event, working fluid is therefore displaced from the storage chamber 23 via the inner channel of the connection line 25 into the interior 12 of the pump part 11. The connection line 25 is configured as a hose.
(45) In other respects, the medical device according to the second illustrative embodiment behaves analogously to the device according to the first illustrative embodiment of the medical device when a stress event occurs, which is why reference is made to the relevant explanations concerning the first illustrative embodiment.
(46)
(47) In the medical device according to the third illustrative embodiment, provision is made that the storage chamber 23 of the auxiliary fluid container 22 is fluidically connected by an auxiliary fluid line 24 to an expansion chamber 21 of an expansion body 20. The auxiliary fluid, separate from the working fluid, could be introduced into the auxiliary fluid line 24 via a port (not shown in detail) or directly into the storage chamber 23. The auxiliary fluid is expediently a liquid, e.g. saline solution.
(48) In this illustrative embodiment, the storage chamber 23 thus forms a part of an auxiliary fluid receiving space of the device for receiving an auxiliary fluid separate from the working fluid. The expansion chamber and the inner channel of the auxiliary fluid line 24 also form a part of the auxiliary fluid receiving space of the device.
(49) In the third illustrative 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.
(50) The volume of the expansion chamber 21 can be increased by introduction of auxiliary fluid into the expansion chamber 21 by unfolding or stretching of the expansion body 20. If the increase in volume is effected purely by unfolding, the expansion body 20 can be made of a non-extensible material, such that the maximum volume of the expansion chamber 21 is limited. Therefore, an increase in the pressure of the working fluid is limited by the limitation of the volume of the expansion chamber 21. However, the volume of the expansion chamber 21 can be increased by an elastically extensible design of the expansion body 20.
(51) The expansion body 20 can also be designed to be pliable, such that the expansion body 21 is then dimensionally unstable, as is indicated in
(52) At least in the shut-off state of the band part 1 shown in
(53) Moreover, in the release state (not shown) of the band part 1, the expansion chamber 21 could be folded up completely, i.e. with a volume substantially equal to zero. This is the case if the auxiliary fluid is at a lower pressure than the working fluid and/or if the auxiliary fluid is forced out of the expansion chamber 21 by the elasticity of the expansion body 20 when there is equality of the pressure (of the auxiliary fluid and of the working fluid). A certain residual volume of the expansion chamber 21 may also be present in the release state.
(54) If the pressure within the body (=internal body pressure) now rises, for example during a coughing fit, the force brought about by the internal body pressure acts directly on the storage container 22. When a force acts on the storage container 22, the pressure of the auxiliary fluid increases correspondingly. If the internal body pressure, and therefore the pressure of the auxiliary fluid, is greater than the pressure of the working fluid, the storage container 22 is compressed and auxiliary fluid is forced out of the storage chamber 23 into the expansion chamber 21. If the expansion body 20 sets an elastic restoring force counter to the expansion of the expansion chamber 21, this elastic restoring force 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 to such an extent that the elastic restoring force is also overcome by the pressure of the auxiliary fluid). The resulting increase of the volume of the expansion chamber 21 leads to an increase of the pressure in the interior 12 of the pump part 11. Working fluid is ejected from the interior 12 and introduced into the hollow chamber 3 of the band part. The inner portion 1a of the band part 1 is thus displaced in the direction toward the longitudinal center axis 5, and the additional force is applied to the body tissue 2 guided through the through-opening 4. This state of the band part 1 (=stress state) is shown in
(55) As the internal body pressure, and therefore the pressure of the auxiliary fluid, subsequently decreases again such that the pressure of the auxiliary fluid is less than the pressure of the working fluid (if appropriate plus the elastic restoring force of the expansion body 20), the volume of the storage chamber 23 of the storage container 22 increases as it receives auxiliary fluid discharged from the expansion chamber 21 of the expansion body 20. After the stress event, the band part 1 is once again located in the shut-off state (cf.
(56)
(57) In the medical device according to the fourth illustrative embodiment, provision is made that the expansion body 20 is arranged at the band part 1, on a side of the band part 1 directed toward the through-opening 4, i.e. on the inner portion 1a. This is shown schematically in
(58) In the closed state of the band part 1, the expansion body 20 arranged at the band part 1 has, in relation to the circumferential direction of the longitudinal center axis 5, a substantially encircling bearing surface 20a for bearing on the body tissue 2.
(59) In the shut-off state of the closed band part 1, the hollow chamber 3 is filled with such a quantity of working fluid that the anatomical channel is closed (cf.
(60) When working fluid is drained off, the band part 1 adopts the release state (not shown) in which the anatomical channel is opened.
(61) If, starting from the shut-off state of the band part 1 shown in
(62) When the internal body pressure again reaches a basic state, i.e. without a stress event being present, the auxiliary fluid flows back out of the expansion chamber 21 into the auxiliary fluid container 22 (cf. the shut-off state of the band part 1 shown in
(63) The reverse flow of the auxiliary fluid into the storage container 22 is thus effected by 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 sets an elastic restoring force counter to the expansion of the expansion chamber 21, this elastic restoring force can have a supporting effect in the reverse flow of the auxiliary fluid.
(64) In the fourth illustrative embodiment, provision can be made that the expansion body 20 and the band part 1 are formed materially in one piece. Provision is advantageously made that the expansion body 20 is designed to be elastically extensible. In another embodiment, however, provision could also be made that the expansion body 20 is designed to be substantially non-extensible and/or pliable.
(65) Besides the pump unit shown in the illustrative embodiments, the storage container could in principle also be used in combination with a pump unit that is commonly known from the prior art and that can be actuated manually, for example.
KEY TO THE REFERENCE NUMBERS
(66) 1 band part 1a inner portion 1b rear portion 2 body tissue 3 hollow chamber 4 through-opening 5 longitudinal center axis 6 first closure part 6a insertion opening 7 second closure part 7a tongue 8 attachment stub 9 working fluid line 9′, 9″ portion of the working fluid line 10 pump unit 11 pump part 12 interior 13 bottom part 14 actuating element 15 drive 16 gear 17 control electronics unit 18 port 19 housing 20 expansion body 20a bearing surface 21 expansion chamber 22 storage container 22a wall 22b reinforcement 23 storage chamber 24 auxiliary fluid line 25 connection line