Medical implant and mechanical mode switch system

Abstract

Disclosed is an implantable tube valve for implanting in a patient, comprising an implantable tube and a valve member mounted inside the tube and pivotable between an open mode and a closed mode. A biasing element preloads the pivot part on the first side of the pivot axis to bistably bias the valve member towards the open or closed mode. The biasing element comprises a compressible sleeve that is axially compressible for providing a preload force on the pivot part. The valve member comprises an operating surface that is mechanically operable by an external actuator device to move the valve member against the preload force between the open and closed mode.

Description

[0001] P138050PC00

[0002] Title: MEDICAL IMPLANT AND MECHANICAL MODE SWITCH SYSTEM

[0003] FIELD OF THE INVENTION

[0004] The invention relates to a medical implant, in particular an implantable tube valve for implanting in a patient to selectively allow and block passage of fluids through an anatomical duct, such as a fallopian tube or a urinary tract. The invention further relates to a system for mechanically switching the implantable tube valve between an open mode and a closed mode.

[0005] DESCRIPTION OF THE PRIOR ART

[0006] Implantable tube valves, designed for implanting in human vessels such as the urinary tract, vas deferens, or fallopian tubes, as disclosed in EP3188699, offer a reliable and efficient solution that can be switched on and off as needed. The publication describes a pivotable valve member that blocks flow through the implantable tube using an actuator mechanism and a biasing arrangement integrated into the tube wall. This biasing arrangement consists of an elastic tension wire and a cam, which bistably hold the valve member in either an open or closed position. Importantly, the design is flat and does not require a significant increase in the tube wall’s thickness.

[0007] However, a drawback of this biasing arrangement is its fragility and the complexity involved in manufacturing and assembly due to the relatively large number of small interconnected components. For this reason, EP4203872 provides an improved arrangement for pivoting and biasing the valve member.

[0008] However, there is still an occasion for further improvements to the design in order to keep reducing complexity and associated manufacturing costs of the known implantable tube valves, while maintaining good reliability. Given the dimensions involved, it is challenging to devise an arrangement that is easy to manufacture and assemble while being incorporated into the tube wall without significantly increasing its thickness. SUMMARY OF THE INVENTION

[0009] The present invention provides an implantable tube valve as defined in the appended claims, for implanting in a patient, e.g. in a fallopian tube, vas deferens, or urinary tract. The implantable tube valve comprises an implantable tube having an inner tube wall extending between two axial tube ends, and a valve member mounted inside the tube. The valve member is pivotable between an open mode and a closed mode. The valve member comprises a pivot part constructed to pivot around a pivot axis oriented lateral relative to the tube. The pivot part is formed as a substantially tubular orifice on a first side of the pivot axis, and aligned, when in open mode, to the tube.

[0010] The pivot part is provided with a single beak part, on a second side of the pivot axis opposite the first side. The beak part has a sealing edge that contacts the inner tube wall, when pivoted in the closed mode, thereby closing off passage through the implantable tube.

[0011] The implantable tube valve further comprises a biasing element that is mounted inside the tube and that preloads the pivot part on the first side of the pivot axis to bistably bias the valve member towards the open or closed mode. The biasing element comprises a compressible sleeve that is axially compressible for providing a preload force on the pivot part. The pivot part is arranged for interacting with the compressible sleeve at a first radial distance from the pivot axis such that the preload force is converted to a torque on the valve member about the pivot axis.

[0012] The valve member comprises an operating surface at a second radial distance from the pivot axis. The operating surface is mechanically operable by an external actuator device to pivot the valve member against the preload force between the open and closed mode.

[0013] Accordingly, a simple, robust and reliable arrangement is provided for selectively allowing and closing off passage of fluids and other particles through the implantable tube valve. In the open and closed mode, the contact between the pivot part and the compressible sleeve is arranged such that the preload force is directed away from the centerline of the tube. In other words, the preload force does not intersect the pivot axis, but eccentrically engages the pivot axis at the first radial distance, the pivot part effectively providing a crank arm, so that a torque about the pivot axis is exerted on the pivot part. Accordingly, upon rotation of the valve member, e.g. by an external actuator, such that the valve member is pivoted away from the open mode or closed mode, the compressible sleeve is compressed until it reaches a neutral state, in which the arm extends parallel to the centerline of the tube. In this neutral state, the preload force of the compressible sleeve intersects the pivot axis. In this neutral state, the compressible sleeve is maximally compressed, thus exerting a maximum force between the tube and the pivot part but without a resulting torque on the valve member. When the valve member is rotated away from the neutral state, the built up force in the compressible sleeve is released into a torque on the pivot part, thereby biasing the valve member to the closed or open mode. As such, the compressible sleeve opposes the rotation of the pivot part when rotating towards the neutral state, and assists the rotation of the pivot part when rotating away from the neutral state. The distal end of the compressible sleeve, i.e. the axial end that is farthest away from the valve member, is mounted to the tube, such that axial displacement of the distal end, and preferably also rotation about the axial centerline, is constrained with respect to the tube, e.g. by one or more mounts. Thus, during operation the axial compression of the compressible sleeve is absorbed and transferred into the wall of the tube that houses the valve member. By constraining the rotation of the compressible sleeve, the mating contact surfaces of the pivot part and the compressible sleeve remain in the correct, predefined position with respect to each other, for bistably biasing the valve member towards the open and closed mode. Furthermore, by constraining said rotation about the axial centerline, the point of contact between the compressible sleeve and the pivot part, and thus the magnitude of the preload force provided by the compressible sleeve, as well as the location and direction of the preload force, is well defined.

[0014] Accordingly, the performance and reliability of the valve is improved.

[0015] Additionally, or alternatively, the rotation of the compressible sleeve about its axial centerline, and thus the relative position between the mating contact surfaces of the compressible sleeve and the pivot part, can be constrained at a different location on the compressible sleeve. For example, in some embodiments the compressible sleeve may be rotationally constrained at its proximal end, e.g. by one or more linkages between the pivot part and the compressible sleeve. Alternatively or additionally, the tube wall may be provided with an axial guide, e.g. formed by one or more slots or grooves in the tube wall, for constraining the rotation of the compressible sleeve about its centerline.

[0016] Preferably, the compressible sleeve is axially compressible by elastic deformation of the compressible sleeve, so that from the maximally compressed length in the neutral state, the compressible sleeve is able to return to its initial axial length in the open and closed mode.

[0017] In order to allow the compressible sleeve to be axially compressed, while providing an axial preload force on the pivot part, the compressible sleeve can be designed in various ways. For example, the compressible sleeve may comprise a section that is axially deformable due to the elastic properties of the material used in that section. Preferably, the inner and outer contour of the compressible sleeve do not change when the compressible sleeve is compressed, to avoid that passage through the implantable tube valve is restricted, in particular in the open mode, and to avoid that the point of contact between the compressible sleeve and the pivot part is altered during compression of the sleeve. In other words, the compressible sleeve preferably allows axial compression without deforming or expanding in a radial direction.

[0018] This can for example be achieved when the compressible sleeve comprises a plurality of tangentially extending cutouts that divide the compressible sleeve into at least two segments that are interconnected in the axial direction by one or more uncut wall sections of the compressible sleeve. The tangentially extending cutouts provide a gap, or space, into which at least one of the at least two segments can axially move when the compressible sleeve is compressed. Said movement may e.g. involve a deformation of a segment, or a deformation of the one or more uncut wall sections, e.g. by said segment and / or uncut wall section(s) bending in the axial direction. The uncut wall section(s) can e.g. be curved or angled in the tangential direction of the compressible sleeve such that an axial force on the uncut wall section results in bending of the uncut wall section in a tangential plane.

[0019] In some embodiments, the at least two segments are ring-shaped, and axially interconnected by a pair of uncut wall sections that extend on opposing sides of the compressible sleeve. At least one of the at least two ring-shaped segments may be arranged for bending in the axial direction to provide the preload force. In other words, between the pair of opposing uncut wall sections the at least one ring-shaped segment has a free section that is unsupported in the axial direction, so that said free section can move into the gap formed by the tangentially extending cutouts by bending in the axial direction in response to an axial force on the compressible sleeve. By reducing the axial length, or thickness, of the at least one ring-shaped segment, the axial bending stiffness can be reduced.

[0020] In preferred embodiments, the compressible sleeve has an outer contour that matches with the inner tube wall of the implantable tube, and an inner contour that matches with the tubular orifice of the valve member. For example, the outer diameter of the compressible sleeve is substantially equal to the inner diameter of the tube. The inner diameter of the compressible sleeve can e.g. be substantially equal to the inner diameter of the orifice of the valve member. In this way the compressible sleeve minimally obstructs, or reduces, the passage through the implantable tube valve. Also, by having the outer contour match the inner tube wall, any space between the compressible sleeve and the inner tube wall is minimized, thereby preventing the accumulation of fluids and other particles between the compressible sleeve and inner tube wall.

[0021] Preferably, the pivot part provides a first contact surface at the first radial distance from the pivot axis, and a first axial end of the compressible sleeve provides a second contact surface that abuts the first contact surface. The pivot part may comprise cylindrically rounded cutouts that match cylindrically rounded ends on the compressible sleeve, such that the compressible sleeve engages the pivot part in a way that allows rotation along the contour of the cylindrically rounded end. Alternatively, the compressible sleeve may be connected to the pivot part in other ways to exert a preload force between the two, e.g. by bearings such as sliding bearings or knife-edge bearings. Alternatively, the compressible sleeve may be an integral part of the pivot part.

[0022] In some variants, the pivot part comprises a cam that extends from the pivot axis towards the compressible sleeve. Said cam can provide the first contact surface. The compressible sleeve may comprise a protrusion that extends from the first axial end of the compressible sleeve towards the pivot axis. Said protrusion can provide the second contact surface. The first contact surface and / or the second contact surface may be rounded. In this way, the first and second contact surface can be arranged for sliding over each other when the valve member moves between the open and closed mode.

[0023] The second axial end of the compressible sleeve, opposite the first axial end, can be provided with one or more mounts for mounting to the inner tube wall of the implantable tube. Such mounts can e.g. include further cylindrically rounded cutouts and mating cylindrically rounded ends, V-grooves, knife edge bearings, or form-closed fixations like bolt or screw fixations, clamps, or adhesive bonds.

[0024] To facilitate assembly, and improve the reliability of the device, at least the compressible sleeve is preferably an integrally formed part. In other words, the compressible sleeve preferably is a single part, rather than multiple parts that are linked together or otherwise cooperate to provide the preload force.

[0025] Optionally, the valve member can be provided with a safety mechanism including the compressible sleeve and the pivot part. In such cases, the beak part may be arranged to pivot the pivot part against the preload force of the compressible sleeve towards the open mode when a pressure exerted on the beak part exceeds a predefined threshold. In other words, the implantable tube valve may have a pressure relief mechanism, arranged for letting fluid pass by opening the valve in case of a too high fluid pressure. In this way, it can be prevented that the fluid pressure upstream the implantable tube valve reaches an excessive value when the valve is closed. This option may be particularly useful when the implantable tube valve is implanted in a urethra of a subject, to avoid a too high pressure of fluid inside the bladder, which may be hazardous for the subject.

[0026] Another aspect of the invention concerns a system for mechanically switching an implantable tube valve between an open mode and a closed mode. The system comprises the implantable tube valve described herein, and an external actuator device arranged for actuating the valve member of the implantable tube valve between the open mode and the closed mode. The external actuator device comprises an actuator rod that is insertable in an axial direction through the compressible sleeve and the valve member and engageable with the operating surface of the valve member to move the valve member against the preload force of the compressible sleeve from the open to the closed mode, and / or vice versa.

[0027] Accordingly, the implantable tube valve can be actuated mechanically, i.e. without the use of electronics inside the implantable tube valve. As a result, the complexity of the implantable tube valve is reduced, as well as the chance of malfunction or failure to operate the valve between the open and closed mode. The valve member preferably comprises a first operating surface arranged for receiving an axial pull force to move the valve member. When the actuator rod of the external actuator device comprises a hook element arranged for applying the axial pull force on the first operating surface, the valve member can be pulled from the open to the closed mode, or in the other direction, depending on the location and orientation of the first operating surface with respect to the pivot axis.

[0028] Alternatively, or additionally, the valve member may comprise a second operating surface arranged for receiving an axial push force to move the valve member. When the actuator rod of the external actuator device comprises a push element arranged for applying the axial push force on the second operating surface, the valve member can be pushed to the open or closed mode.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The invention will be further elucidated in the figures:

[0031] Figure 1A-B shows an embodiment of an implantable tube valve for implanting in a subject;

[0032] Figure 2A-B shows another or further embodiment of the implantable tube valve in more detail;

[0033] Figure 3 illustrates yet another or further embodiment of the implantable tube valve;

[0034] Figure 4 illustrates an embodiment of a system for mechanically switching the implantable tube valve described herein, between the open and closed mode;

[0035] Figures 5A-B provide cross section views of an embodiment of the system. DETAILED DESCRIPTION

[0036] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs as read in the context of the description and drawings. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. In some instances, detailed descriptions of well-known devices and methods may be omitted so as not to obscure the description of the present systems and methods. Terminology used for describing particular embodiments is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "and / or" includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms "comprises" and / or "comprising" specify the presence of stated features but do not preclude the presence or addition of one or more other features. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control.

[0037] The term “mount” is used in its ordinary meaning to emphasize that many mounting arrangements are possible. These arrangements include physical shaft mounts, ball bearing mounts or any other mechanical arrangement providing a rotational degree of freedom for the valve member mounted in the mount. The rotational degree of freedom defines an axis of rotation or pivot axis that is transverse to the implantable tube. Preferably, the mount is formed partly by the tube, and a corresponding mount part formed by the valve member. The term “conformal to” is used in its ordinary meaning to indicate the form following nature of the identified features, meaning that shape and size are similar for a substantial part of said features. In mathematical sense the meaning conformal indicates that the features preserve shape on a local scale. To illustrate that some deviation may be allowed, depending on the specifics of the application it is considered that certain features, e.g. a valve member’s outer and inner face are considered conformal if a thickness between the two varies with e.g. less than 10%.

[0038] In stricter sense, it is considered that ‘contiguous to’ means that the form is not only similar, but identical so that there virtually no or only a very small gap between the two features, e.g. less than 0.1 mm. In a more abstract sense, the term ‘coincides with’ is used to indicate that a feature is enveloped by a notional feature coinciding with an outer face over a substantial part of said feature.

[0039] By the term ‘extending continuously’ e.g. between axial tube ends, it is indicated that there are no substantial deviations present between said extensions, notably no or very limited protruding outer features, in respect of the implantable tube. In particular, the implantable tube extending continuously between the axial tube ends indicates that there is no or very limited spatial deviation from the tube form along the entire tube. The term continuous does nevertheless not preclude the presence of minor protrusions or depressions, e.g. for forming an actuator housing, sealing edge, mounting or valve seat on a smaller scale or for forming a rugged surface e.g. for fixed insertion in the human vessel, e.g. in the form known for stents. It is indicated on a larger scale that the general flow through the object may be unobstructed due to the tube’s continuous form, or that the object itself does not substantially deviate from a tube form. In particular, depending on its application, the actuator actuating the valve member is shaped in elongated form along the tube in a way that can be absorbed by stretching the surrounding tissue, e.g. the urinary tract. While example embodiments are shown for systems and methods, also alternative ways may be envisaged by those skilled in the art having the benefit of the present disclosure for achieving a similar function and result. E.g. some components may be combined or split up into one or more alternative components. Finally, these embodiments are intended to be merely illustrative of the present system and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments. Thus, while the present system is described in particular detail with reference to specific exemplary embodiments thereof, it should also be appreciated that numerous modifications and alternative embodiments may be devised by those having ordinary skill in the art without departing from the scope of the present systems and methods as set forth in the claims that follow. The specification and drawings are accordingly to be regarded in an illustrative manner and are not intended to limit the scope of the appended claims.

[0040] Any reference signs in the claims do not limit their scope; several "means" may be represented by the same or different item(s) or implemented structure or function; any of the disclosed devices or portions thereof may be combined together or separated into further portions unless specifically stated otherwise. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage.

[0041] In Figures 1A-B, there is illustrated an embodiment of an implantable tube valve 100 for implanting in a subject. Variants of the implantable tube valve 100 may for example be suitable for implanting in a urinary tract of the subject, in particular in the urethra. Generally, the male urethra is 16–22 cm in length, with an average inner diameter of 5–7 mm, while the female urethra is 3–5 cm long, with an inner diameter of about 6 mm. The length and outer diameter of the implantable tube valve 100 may be such that the implantable tube valve 100 fits inside the male or female urethra. Other variants of the implantable tube valve 100 may be configured to be implantable in a fallopian tube of a female subject. The fallopian tube is generally 10-13 cm long and may be less than 5 mm in diameter. The dimensions of the implantable tube valve 100 can be adapted to match the size and shape of the anatomy in which it is to be implanted. The implantable tube valve 100 can e.g. have an outer diameter of 8 millimeter or smaller, down to 1 millimeter, e.g. between 1 and 5 millimeter. The tube valve 110 may be implanted by means of a catheter insertion.

[0042] The function of the implantable tube valve 100 is to selectively allow and block passage of fluids and other particles through the anatomic duct in which it is implanted. For example, when implanted in a urethra the implantable tube valve 100 can be used to control the flow of urine through the urethra, e.g. to support a subject that deals with incontinence. The implantable tube valve 100 can e.g. allow the subject to open and close the valve at will. In other examples, e.g. when the implantable tube valve 100 is implanted in a fallopian tube, the implantable tube valve 100 can be used as an contraceptive measure. By closing the implantable tube valve 100 it can be prevented that the subject is impregnated. The implantable tube valve 100 may also be dimensioned and configured to be implantable in other anatomic ducts where a continuous flow of fluids and / or other particles is not always required, or in bypasses or shunts, e.g. for hemodialysis. Also, depending on the configuration the device may be implanted in other vessels such as the vas deferens.

[0043] Figure 1A illustrates an embodiment of the implantable tube valve 100 in an open mode in which passage of fluids is allowed, while Figure 1B illustrates the embodiment in a closed mode in which the passage is blocked. As illustrated, the implantable tube valve 100 comprises an implantable tube 101 having an inner tube wall 102 that extends between two axial tube ends 103, 104. The implantable tube valve 100 is configured to selectively allow and block a flow of fluid and / or other particles from the first axial end 103 to the second axial end 104 of the tube 101. To achieve this, a valve member 200 is mounted inside the tube 101 and pivotable between an open mode (see Figure 1A) and a closed mode (see Figure 1B). The valve member 200 comprises a pivot part 201 constructed to pivot around a pivot axis 202 that is oriented lateral relative to the tube 101.

[0044] The pivot part 201 is formed as a substantially tubular orifice on a first side of the pivot axis 202. In the open mode, the pivot part 201 is aligned to the tube 100. In other words, the centerline of the tubular orifice is in line with the centerline of the tube 101.

[0045] On a second side of the pivot axis 202 opposite the first side, the pivot part 201 is provided with a single beak part 203. The beak part 203 has a sealing edge 204 that contacts the inner tube wall 102 when the valve member 200 is pivoted in the closed mode. As a result the valve member 200 closes off passage through the implantable tube 101.

[0046] A biasing element 300 is mounted inside the tube 101 and preloads the pivot part 201 on the first side of the pivot axis 202 to bistably bias the valve member 200 towards the open or closed mode. The biasing element 300 comprises a compressible sleeve 301 that is axially compressible for providing a preload force Fp on the pivot part 201. This is further explained with reference to Figures 2A and 2B.

[0047] The pivot part 201 is arranged for interacting with the compressible sleeve 301 at a first radial distance Dl from the pivot axis 202. The first radial distance Dl converts the preload force Fp into a torque on the valve member 200 about the pivot axis 202. As illustrated in Figure 2 A, the contact point between the compressible sleeve 301 and the pivot part 201 is located above the pivot axis 202, e.g. at a radial arm, such that the preload force Fp creates a counterclockwise torque T1 that biases the valve member 200 to the open mode. As illustrated in this embodiment the pivot part 201 comprises a cam 211 that extends from the pivot axis 202 towards the compressible sleeve 301 and that provides a first contact surface at the first radial distance Dl from the pivot axis. The compressible sleeve 301, in turn, comprises a protrusion 311 that extends from the first axial end of the compressible sleeve 301 towards the pivot axis 202 and that provides a second contact surface that abuts the first contact surface of the cam 211. The first and / or the second contact surface are preferably rounded, so that they can slide over each other when the valve member 200 moves between the open and closed mode.

[0048] In the closed mode, the point of contact between the compressible sleeve 301 and the pivot part 201 is below the pivot axis 202, thereby causing a clockwise torque T2 that biases the valve member 200 to the closed mode. The first radial distance Dl thus changes as the valve member 200 is moved from the open mode to the closed mode, and vice versa. In particular, the first radial distance Dl is largest when the valve member 200 is either in the open or closed mode, and is zero when the valve member 200 is in a neutral mode, i.e. exactly in between the open and closed mode. In the neutral mode, the compressible sleeve is maximally compressed. That is, the preload force Fp is highest in the neutral mode of the valve member 200. In this situation, the preload force is in line with the pivot axis 202 so that it merely results in a push force on the pivot axis 202. However, this position is unstable since any clockwise or counterclockwise rotation of the valve member 200 about the pivot axis 202 away from the neutral mode creates a non-zero arm or radial distance Dl, which results in a biasing torque on the valve member 200. Hence, the valve member 200 is bistably biased towards the open and closed mode.

[0049] Preferably, the compressible sleeve 301 is axially compressible by elastic deformation of the compressible sleeve 301, so that the compressible sleeve returns to an initial shape when the preload force Fp is reduced.

[0050] The compressible sleeve 301 may for example comprise a plurality of tangentially extending cutouts 320 that divide the compressible sleeve 301 into multiple segments 330, as can be seen in Figure 2A and B. The cutouts 320 preferably extend discontinuously in the tangential direction, so that one or more uncut wall sections 335 remain present between the segments 330, and interconnect the segments 330 in the axial direction Z. The uncut wall section 335 are preferably arranged for constraining a rotation of the segments 330 relative to each other about the centerline of the compressible sleeve 301.

[0051] Preferably, the distal axial end of the compressible sleeve 301, i.e.. the axial end farthest removed from the pivot part 201, is provided with one or more mounts 309 that axially and rotationally constrain the distal axial end of the compressible sleeve with respect to the inner tube wall 102.

[0052] Depending on the shape and pattern of tangential cutouts 320, the segments can e.g. be ring-shaped. For symmetry, the ring-shaped segments 330 may be axially interconnected by a pair of uncut wall sections 335 that extend on opposing sides of the compressible sleeve 301. Elastic compression of the compressible sleeve 301 in the axial direction occurs by at least one of the ring-shaped segments bending in the axial direction Z. As a result, the compressible sleeve provides a certain level of preload force Fp that is proportional to the degree of elastic deformation of the segments 330 and / or uncut wall sections 335. As illustrated in Figures 2A and 2B, the uncut wall sections 335 are preferably misaligned with each other in the axial direction of the compressible sleeve 301. For example, in the axial direction Z, the compressible sleeve 301 may comprise an alternating series of tangential cutouts 320 and uncut wall sections 335. The compressible sleeve 301 can be manufactured as an integrally formed part, i.e. a single piece component.

[0053] Figure 3 illustrates an embodiment of the implantable tube valve 100. For clarity, some elements of the device 100 are not illustrated in this figure, like the tube 101. Figure 3 shows that the compressible sleeve 301 may comprise a tangential cutout 320 that spirals around the centerline of the compressible sleeve 301. This causes part of the compressible sleeve 301 to have a coil shape, which can be compressed in the axial direction Z. As illustrated, a pair of notches 317, e.g. V-shaped cutouts, may be provided in the axial end of the compressible sleeve slightly offset from the centerline. The notches 317 may be arranged for receiving a cam 211 that protrudes from the pivot part 201, and the position of the notches 317 may correspond with a position of the cam 211 in the open and closed modes, respectively. The notches 317 are preferably directly adjacent each other in the tangential direction, and the area between the notches is preferably pointed outwards in the axial direction towards the pivot part 201, so that the cam 211 cannot be stably supported in the area between the notches 317. As a result, a bistable biasing arrangement is provided that biases the valve member 200 towards either the open mode or the closed mode. In this embodiment, the axial end of the compressible sleeve 301 that contacts the pivot part 201 is preferably constrained to prevent rotation about the centerline of the sleeve 301, e.g. by means of a linear guide optionally involving one or more protrusions that are guided through slotted holes that extend in the axial direction, to ensure reliability of the bistable biasing mechanism.

[0054] Without being limited to a particular embodiment, in order to limit the obstruction of flow inside the implantable tube valve 100 when the valve member 200 is in the open mode, the compressible sleeve 301 preferably has an outer contour that matches with the inner tube wall 102 of the implantable tube. For example, the outer diameter of the compressible sleeve 301 is about equal to, or only slightly smaller than, the inner diameter of the inner tube wall 102. The inner contour of the compressible sleeve 301 preferably matches with the tubular orifice of the valve member 200. For example, the inner diameter of the compressible sleeve 301 is about equal to the inner diameter of the tubular orifice of the pivot part 201.

[0055] The second axial end of the compressible sleeve 301, opposite the first axial end that abuts the pivot part 201, is fixated to the tube 101. To achieve this, the compressible sleeve 301 at its second axial end can be provided with one or more mounts 309 for mounting to the inner tube wall 102 of the implantable tube 101. The one or more mounts 309 for example include mating geometries of the compressible sleeve 301 and the tube 101. For example, the compressible sleeve 301 may comprise one or more cutouts, such as holes or V-grooves, that mate with one or more corresponding protrusions the extend from the inner tube wall 102, so that the second axial end of the compressible sleeve 301 is constrained in the axial direction Z. Hence, the preload force Fp onto the pivot part 201 can be transferred to the inner tube wall 102, which is relatively rigid in the axial direction.

[0056] To operate the valve member 200 between the open and closed mode, the valve member 200 comprises an operating surface 221 at a second radial distance D2 from the pivot axis 202. The operating surface 221 can e.g. be provided on the beak part 203. The operating surface 221 is mechanically operable by an external actuator device to pivot the valve member 200 against the preload force Fp between the open and closed mode.

[0057] In other words, the implantable tube valve 100 may be part of a system 10 for mechanically switching the implantable tube valve between the open mode and the closed mode. Such a system 10 further comprises an external actuator device 50, as illustrated in Figure 4. The external actuator device is arranged for actuating the valve member 200 of the implantable tube valve 100. The external actuator device 50 comprises an actuator rod 51 that is insertable through the compressible sleeve 301 and the valve member 200 and engageable with the operating surface 221 of the valve member to move the valve member against the preload force of the compressible sleeve 301 from the open to the closed mode, and / or vice versa. Accordingly, the implantable tube valve 100 can be mechanically operated, i.e. without the use of electronics, to provide a simple yet robust and reliable solution.

[0058] Figures 5A and B provide a cross section view of an exemplary embodiment of the system 10.

[0059] As illustrated, the valve member 200 comprises a first operating surface 221 arranged for receiving an axial pull force to move the valve member, and the actuator rod 51 of the external actuator device 50 comprises a hook element 55 arranged for applying the axial pull force on the first operating surface 221. The hook element 55 can e.g. be formed by a radial protrusion that extends from the actuator rod 51. The actuator rod 51 may provide the hook element 55 as part of a snap-fit connection. For example, the hook element 55 may be resilient in the radial direction R of the actuator rod 51. When inserting the actuator rod 51 into one of the axial ends of the implantable tube valve 100, the hook element 55 may be bent inward as the actuator rod 51 is pushed consecutively through the compressible sleeve 301 and the valve member 200. When the actuator rod 51 exits the valve member 200, the hook element 55 can expand radially outward towards a neutral state where the hook element 55 radially abuts the inner tube wall 102. From this position, the hook element 55 can engage the first operating surface 221 of the valve member 200, and an axial pull force Fpullin the axial direction Z on the actuator rod 51 generates a torque that opens the valve member 200.

[0060] The valve member 200 may additionally or alternatively comprise a second operating surface (not shown) arranged for receiving an axial push force to move the valve member. In this case the actuator rod 51 of the external actuator device may comprise a push element arranged for applying the axial push force on the second operating surface. The push element may be formed by a distal end surface of the actuator rod 51.

[0061] Optionally, the valve member 200 can be provided with a safety mechanism including the compressible sleeve 301 and the pivot part, to prevent buildup of excessive pressure in the fluid upstream the valve member 200, which may be harmful for the subject. The beak part 203 can e.g. be arranged to pivot the pivot part 201 against the preload force of the compressible sleeve 301 towards the open mode when a fluid pressure exerted on the beak part 203 by a fluid inside the implantable tube valve 100 exceeds a predefined threshold. In other words, the implantable tube valve 100 provides a pressure relief valve.

[0062] The pivot part 201 and the beak part 203 are thus designed to exert a torque that pivots the pivot part 201 to the open mode. Such a design can for example be provided by taking advantage of the asymmetric design of the beak part 203 relative to the pivot part 201. The biasing element 300 may be connected to the pivot part 201 and arranged for bistably biasing the valve member 200 towards the open or closed mode. When the pressure upstream the valve member, e.g. inside the bladder of the subject in case the implantable tube valve 100 is implanted in the subject’s urethra, exceeds a certain threshold, e.g. is larger than 1.2 bar, the pivot part 201 is designed, together with the biasing element 300 to mechanically comply with the exerted pressure, and a torque is provided by the fluid pressure exerted on the asymmetric beak part 203, which rotates the pivot part 201.

[0063] Initially, a certain torque provided by the beak part 203 in response to an acceptable bladder pressure may be too small to counteract the preload force Fp exerted by the compressible sleeve 301, and the beak part 203 thus remains in closed position.

[0064] When a pressure is increased the torque that is exerted by the beak part 203 to counteract the compressible sleeve 301 will increase also. This will result in a partial opening of the beak part 203, to relieve some of the pressure and keep the upstream pressure below a threshold pressure which is important for the safety of the patient, e.g. as a bladder rupture due to overpressure may have life-threatening consequences.

[0065] Depending on the design of the biasing element, a bistable characteristic of the biasing element (e.g.: by a snap force design) may result in (sudden) yielding of the beak part to the open mode. In this case, the bladder is emptied and no remaining pressure will be there.

[0066] The safety mechanism is an optional addition to a voluntary operation of the valve member from the closed mode to the open mode, by actively pivoting pivot part 201 by an external actuator, e.g. of a design as depicted in Figure 3. Thus, the safety mechanism may only function in emergency conditions irrespective of a voluntary movement initiated by an actuator, but follows from a constructional design that is arranged to exert a torque that pivots the pivot part when exceeding a threshold pressure, whether or not the subject or operator of the tube valve is actively controlling the valve member via an actuator input. This may occur when e.g. the feeling of a filled bladder is missing, the person is unconscious or the external device to control the actuation is not available or inoperative.

[0067] It may be understood by the skilled person that the arrangements depicted in the embodiments were directed to idealized shapes, but in practice may be suitably (de) formed e.g. in round, not necessarily circular forms and rotation symmetric, not necessarily spheric shapes but aspheric shapes for example, ellipsoid shapes, without departing from the invention as defined in the appended claims.

Claims

CLAIMS1. Implantable tube valve for implanting in a subject, comprising:- an implantable tube having an inner tube wall extending between two axial tube ends;- a valve member mounted inside the tube and pivotable between an open mode and a closed mode, wherein the valve member comprises a pivot part constructed to pivot around a pivot axis oriented lateral relative to the tube; said pivot part formed as a substantially tubular orifice on a first side of the pivot axis, aligned, when in open mode, to the tube, and said pivot part provided with a single beak part, on a second side of the pivot axis opposite the first side; the beak part having a sealing edge contacting the inner tube wall when pivoted in the closed mode, the valve member thereby closing off passage through the implantable tube; and- a biasing element, mounted inside the tube and preloading the pivot part on the first side of the pivot axis to bistably bias the valve member towards the open or closed mode;wherein the biasing element comprises a compressible sleeve that is axially compressible for providing a preload force on the pivot part, wherein the pivot part is arranged for interacting with the compressible sleeve at a first radial distance from the pivot axis such that the preload force is converted to a torque on the valve member about the pivot axis; andwherein the valve member comprises an operating surface at a second radial distance from the pivot axis, wherein the operating surface is mechanically operable by an external actuator device to pivot the valve member against the preload force between the open and closed mode.

2. The implantable tube valve according to claim 1, wherein the compressible sleeve is axially compressible by elastic deformation of the compressible sleeve.

3. The implantable tube valve according to any preceding claim, wherein the compressible sleeve comprises a plurality of tangentially extending cutouts that divide the compressible sleeve into at least two segments, wherein the at least two segments are interconnected in the axial direction by one or more uncut wall sections of the compressible sleeve.

4. The implantable tube valve according to claim 3, wherein the at least two segments are ring-shaped, and axially interconnected by a pair of uncut wall sections that extend on opposing sides of the compressible sleeve, wherein at least one of the at least two ring-shaped segments is arranged for bending in the axial direction to provide the preload force.

5. The implantable tube valve according to any preceding claim, wherein the compressible sleeve has an outer contour that matches with the inner tube wall of the implantable tube, and an inner contour that matches with the tubular orifice of the valve member.

6. The implantable tube valve according to any preceding claim, wherein the pivot part provides a first contact surface at the first radial distance from the pivot axis, and wherein a first axial end of the compressible sleeve provides a second contact surface that abuts the first contact surface.

7. The implantable tube valve according to claim 6, wherein the pivot part is comprises a cam that extends from the pivot axis towards the compressible sleeve, wherein the cam provides the first contact surface.

8. The implantable tube valve according to claim 6 or 7, wherein the compressible sleeve comprises a protrusion that extends from the first axial end of the compressible sleeve towards the pivot axis, wherein the protrusion provides the second contact surface.

9. The implantable tube valve according to any of claims 6-8, wherein the first contact surface and / or the second contact surface is rounded, and wherein the first and second contact surface are arranged for sliding over each other when the valve member moves between the open and closed mode.

10. The implantable tube valve according to any preceding claim, wherein a second axial end of the compressible sleeve is mounted to the inner tube wall of the implantable tube by one or more mounts, wherein the one or more mounts constrain a rotation of the compressible sleeve with respect to the inner tube wall, about an axial centerline of the compressible sleeve.

11. The implantable tube valve according to any preceding claim, wherein the compressible sleeve is an integrally formed part.

12. The implantable tube valve according to any preceding claim, wherein the valve member is provided with a safety mechanism including the compressible sleeve and the pivot part; wherein the beak part is arranged to pivot the pivot part against the preload force of the compressible sleeve towards the open mode when a fluid pressure exerted on the beak part by a fluid inside the implantable tube valve exceeds a predefined threshold.

13. A system for mechanically switching an implantable tube valve between an open mode and a closed mode, comprising:- the implantable tube valve according to any of the preceding claims; - an external actuator device arranged for actuating the valve member of the implantable tube valve between the open mode and the closed mode;wherein the external actuator device comprises an actuator rod that is insertable in an axial direction through the compressible sleeve and the valve member and engageable with the operating surface of the valve member to move the valve member against the preload force of the compressible sleeve from the open to the closed mode, and / or vice versa.

14. The system according to claim 13, wherein the valve member comprises a first operating surface arranged for receiving an axial pull force to move the valve member, and wherein the actuator rod of the external actuator device comprises a hook element arranged for applying the axial pull force on the first operating surface.

15. The system according to claim 13 or 14, wherein the valve member comprises a second operating surface arranged for receiving an axial push force to move the valve member, and wherein the actuator rod of the external actuator device comprises a push element arranged for applying the axial push force on the second operating surface.

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