Device for controlling the flow circulating in the lumen of a vas deferens in a male individual.

Abstract

The invention relates to a device for controlling a flow circulating in the lumen of a male vas deferens, comprising a clamp configured to coaxially grasp an outer wall of the vas deferens and a long, slender element coupled to the clamp, a distal portion of which is adapted to be at least partially inserted into the vas deferens. Said distal portion has a deflection tube adapted to divert said flow out of the vas deferens when an inlet of said deflection tube is aligned with the lumen. Abstract figure: Fig. 1

Description

Title of the invention: Device for controlling the flow circulating in the lumen of a vas deferens of a male individual. technical field

[0001] The present invention is in the field of mechanical contraceptive devices and more particularly reversible systems, that is to say, allowing a return to a fertile state after a contraceptive period. State of the art

[0002] Devices for mechanically controlling fertility in a male individual have been known for a long time.

[0003] A first category among these devices corresponds to single-use and / or disposable devices such as condoms. These devices are effective and reversible but are only suitable for human use. They also generate a very high amount of waste per individual, in addition to creating a mental burden since it is necessary to always have a device on hand in advance.

[0004] Another category concerns implantable devices, which can be used in humans or animals. Although these partially resolve the problems associated with the first category of devices, most of them present significant disadvantages due to their design irreversibility or uncertain reversibility. In the latter case, this particularly applies to devices that require the vas deferens to be cut for implantation so that their ends can be connected to it.

[0005] Document EP 3128965 B1 presents an example of such a device.

[0006] Finally, some implantable devices that are inserted lengthwise into the vas deferens are known.

[0007] Document US3848578A provides an example.

[0008] Such devices, whether occlusive or not, do not guarantee a good seal and therefore do not provide reliable contraception because the vas deferens is made of living biological tissue which is subject to varying pressures and can therefore contract or dilate. The fluid can thus bypass the device, rendering it ineffective. Summary of the invention

[0009] The invention aims to improve the situation described above.

[0010] The invention aims to remedy the disadvantages of the prior art, by proposing a minimally invasive control device whose positioning does not require sectioning of the vas deferens, in particular unlike vasectomy.

[0011] Another object of the invention is to propose a reversible control device which makes it possible to temporarily modify the path of the flow coming from an upstream portion of the vas deferens, from the testicles and epididymides.

[0012] Another object of the invention is to provide a control device whose actuation requires the intervention of a healthcare professional, and with redundant safety.

[0013] Another object of the invention is to provide a control device which limits the risks of undesired disengagement of the vas deferens.

[0014] Finally, another objective of the invention is to offer an inexpensive control device which does not require complex equipment for its installation by a practitioner, and therefore allows the intervention to be carried out more quickly and in a simplified environment.

[0015] According to the invention, the device for controlling a flow circulating in the lumen of a vas deferens of a male individual comprises:

[0016] - a clamp configured to coaxially grip the outer wall of the channel deferent along an axis of light F; and

[0017] - a long, slender element, coupled to the clamp, a distal part of which is adapted to be introduced at least partially into the vas deferens and has a diverting tube capable of diverting said flow out of the vas deferens when an inlet of said diverting tube is aligned with the lumen.

[0018] A vas deferens consists of a tubular wall, the hollow interior of which is called the lumen, through which the blood flows. The tubular wall of the vas deferens is composed of three layers, from the outside in: an adventitia, a muscularis, and a mucosa. The lumen is stellate. A human vas deferens has an external diameter of between 2 mm and 3 mm, while its stellate lumen has a diameter of between 0.2 mm and 0.7 mm.

[0019] From a biological point of view, in mammals the vas deferens is vascularized by the deferential artery which is attached to the lower part of its wall and such a configuration makes techniques and devices requiring dissection of the vas deferens more hazardous compared to the device according to the invention.

[0020] Thus, the device according to the invention employs a clamp configured to coaxially grasp the outer wall of the vas deferens, preferably by means of a pair of jaws having, in the closed position, an air gap smaller than the diameter of said vas deferens and larger than the diameter of the vas deferens artery, and even more preferably an air gap at the free end of the clamp smaller than the diameter of said vas deferens and larger than the diameter of the vas deferens artery. The air gap, particularly at the free end of the clamp, is advantageously between 0.8 mm and 1.5 mm.

[0021] There is therefore no interaction with the artery or any possibility of injury to it. The clamp allows the device to be positioned at the location desired by the practitioner at the level of the vas deferens, that is to say more or less upstream or downstream along its length.

[0022] By coaxially gripping the outer wall of the vas deferens, the clamp of the control device protects the area of ​​action of the elongated element that controls the flow. When the vas deferens is at rest, the clamp grips it without compressing it, while when the vas deferens is under stress, it contracts and dilates, and the clamp helps to contain this dilation.

[0023] The elongated element has a distal portion adapted to be at least partially inserted into the vas deferens. The distal portion is configured so that its dimensions are smaller than the overall diameter of the vas deferens and larger than the diameter of the lumen of said vas deferens, so that the mucosa forms a natural seal around said distal portion. The sealing effect of the mucosa on the distal portion is reinforced by the coaxial clamping action of the forceps, which contains the dilation of the vas deferens when it is activated.

[0024] Preferably, the distal portion is adapted to be at least partially inserted into the lumen of the vas deferens. The distal portion of the elongated element may include a tapered end to facilitate insertion.

[0025] Advantageously, the distal part of the long element is suitable for being introduced into the vas deferens, preferably in and / or around the lumen, along an axis perpendicular to the axis F.

[0026] Thus, the area of ​​action of the device is minimized compared to devices with linear insertion that follow the lumen of the vas deferens over a considerable length. Consequently, the device according to the invention is minimally invasive. Any inflammation caused by insertion and prolonged placement in the vas deferens is therefore reduced, and the device thus meets the requirements for high tolerance and long lifespan. Furthermore, insertion along an axis perpendicular to the F axis significantly impacts the seal formed by the mucosa around the distal part of the device. This seal therefore results primarily from forces directed along the F axis. Consequently, there is little or no radial stress, and leakage is avoided compared to devices of the prior art with linear insertion.

[0027] The elongated element may further have a through-opening capable of allowing flow along axis F when the opening is aligned with the lumen of the vas deferens. Thus, the device according to the invention is both reversible, in the sense that fertility is restored once removed from the individual's body, and also in the sense that fertility is possible while remaining implanted in the subject's body.

[0028] Advantageously, the clamp comprises a pair of movable jaws between an open position and a closed position in which the inner surfaces respectively of the first and second jaws each come opposite the outer wall of the vas deferens.

[0029] Preferably, the first and second jaws constitute arched portions suitable for each to come into contact with the outer wall of the vas deferens, the pair of jaws having in closed position an elliptical profile in the plane perpendicular to the axis F.

[0030] Quite preferably, the first and second jaws made up of arched lamellae.

[0031] Advantageously, the first and second jaws are connected by a flexible hinge. The flexible hinge allows the pair of jaws to move easily between the open and closed positions. In preferred embodiments of the invention, the body of the gripper is formed by the flexible hinge.

[0032] In such variants of the invention in which the elastic hinge connects the jaws or in which the body of the clamp is constituted by the elastic hinge, the number of parts constituting the device is reduced.

[0033] Preferably, the gripper and / or the elastic hinge is configured to allow the pair of jaws to be mobile between an open position corresponding to a passive position in which the gripper is mechanically at rest and a closed position corresponding to an active position in which the gripper is subjected to restoring forces which tend to make it return to the passive open position.

[0034] In advanced embodiments, the clamp advantageously includes a locking mechanism in the closed position in which it coaxially grips the outer wall of the vas deferens along an axis of the lumen F, whether the closed position is active or not. Preferably, the locking mechanism is configured to temporarily immobilize the pair of jaws in the closed position. For example, the locking mechanism may be a pivoting arch. Such a locking mechanism secures the clamp around the vas deferens. Preferably, the elastic hinge includes the locking mechanism in the closed position.

[0035] Most preferably, in embodiments where the clamp and / or the elastic hinge is configured to allow the pair of jaws to move between a passive open position and an active closed position, the locking means is suitable for maintaining the device in the active closed position and comprises a hooking means such as a tenon, a cam, or a hook, and a receiving means such as a groove cooperating by overlapping and blocking, by opposing forces, the return to the passive open position. In such embodiments, the locking means is, for example, of the push-lock type or the push-to-close type.

[0036] Regardless of the embodiment, the locking means can be disposed at any suitable location on the clamp, for example at at least one of its arms and / or at a portion of at least one of the jaws.

[0037] In certain embodiments of the invention, the clamp is essentially U-shaped, the first and second jaws being arranged respectively at the free end of the first and second branches of the U. Preferably, the elastic hinge is essentially U-shaped, the first and second jaws being arranged respectively at the free end of the first and second branches of the U.

[0038] The body of the clamp and / or the elastic hinge may, for example, consist of at least one curved tab essentially in the shape of a U.

[0039] Of course, any curved shape essentially in the shape of a U or a C is conceivable.

[0040] Advantageously, the clamp includes at least one actuating means configured to release the locking means when the latter holds the device in the closed position, for example by the exercise of a lever force or pressure.

[0041] Preferably, the elastic hinge includes at least one actuating means. Most preferably, the locking means includes at least one actuating means, which allows the device to be optimized in terms of compactness and / or number of parts.

[0042] The actuation means may, for example, be a lug, a trigger or a blind hole, on which the exercise of a lever force or pressure, manually or with the aid of a tool, triggers the opening of the locking means.

[0043] Advantageously, the receiving means of the locking means in the active closed position includes said actuation means.

[0044] In embodiments of the invention in which the clamp and / or hinge is essentially U- or C-shaped, the locking and / or actuating means is preferably located on the internal surface of the clamp, for example, on the internal surface of at least one arm of the U or C, or at the free end located within the internal space of the clamp relative to a jaw. The locking means therefore operates within the internal space defined by the arms of the U or C of the clamp body and / or hinge, and preferably before the pair of jaws. Thus, the risks of unintentional opening or breakage of the locking and / or actuating means, or the risks of undesirable friction with organic tissues, are greatly reduced since these are protected and confined within this internal space.

[0045] Advantageously, the receiving means and the attachment means are each disposed at one of the arms of the U-shaped clamp associated with one of the jaws or at the level of the free end positioned in the internal space of the clamp and relative to the other jaw.

[0046] Preferably, the receiving means and the hooking means are arranged at the level of the internal surface of the clamp.

[0047] Even more preferably, the receiving means is disposed at the level of the internal surface of one of the branches of the U-shaped hinge associated with one of the jaws and the hooking means is disposed at the level of the free end disposed in the internal space of the clamp and relative to the other jaw.

[0048] In order to control the flow without creating disturbance or blocking it, the device includes a long-slender element whose distal part has a through opening capable of allowing the flow to pass along the axis F, without deflecting it; when the opening is aligned with the light, the device is then in the operating mode called "fertility mode" in which its presence is imperceptible to the individual.

[0049] Also, still in order to control the flow without creating disturbance or blocking it, the long element has a diverting tube capable of diverting said flow out of the vas deferens, towards the inside of the individual's body, when an inlet of said diverting tube disposed at the distal part of said long element is aligned with the lumen of the canal, the device is then in the operating mode called "contraception mode".

[0050] Preferably, the diverter tube extends between the distal and proximal parts of the longitudinal element and has an outlet opening at the level of said proximal part.

[0051] In order to couple the elongated element to the gripper, at least one jaw advantageously has one or more of the following characteristics: - a bore allowing the insertion of said elongated element, - at least one means of locking the long element, possibly with a perforation, such as a keying shoe.

[0052] In preferred embodiments of the invention, the bore passes through the first jaw, and the locking means is disposed on the external surface of the clamp at the level of the first jaw and has a perforation aligned with said bore. In these embodiments, the proximal part of the elongated element preferably forms a head adapted to abut against the locking means when the elongated element is inserted simultaneously through the perforation and the bore. The head may be asymmetrical in order to indicate, like a misleading device, the mode of fertility or the mode of contraception.

[0053] Furthermore, in order to facilitate manufacturing and reduce the number of parts of the device, the through opening and the inlet of the diverter tube are advantageously communicating, and preferentially arranged to the right of one another.

[0054] The diverting tubing may further include a means for closing the flow when the through opening is aligned with the axis F when the device is operating in fertility mode.

[0055] Finally, in order to facilitate its manufacture and biological tolerance, the device according to the invention is preferably made of polyetheretherketone. Figures

[0056] Other features and advantages of the present invention will become apparent from the description below, with reference to the attached Figures 1 to 4, which illustrate an example of an embodiment without being limiting in any way and on which:

[0057] [Fig.1]

[0058] Fig. 1 represents the control device according to the invention in exploded view and in closed position for the clamp;

[0059] [Fig.1B]

[0060] Fig. 1B represents a transparent wireframe top view of the elongated element;

[0061] [Fig.2]

[0062] Fig. 2 represents a control device according to the invention, the clamp of which is in the closed position, gripping the vas deferens, and the long element is in fertility mode, seen from the side;

[0063] [Fig.3]

[0064] Fig. 3 illustrates a control device according to the invention in which the clamp is in the open position and the long element is in fertility mode, seen from the side;

[0065] [Fig.4]

[0066] Figure 4 illustrates a control device according to the invention, in which the clamp is in the open position and the elongated element is in contraceptive mode, seen from the side; Detailed description

[0067] An embodiment of the device according to the invention is presented below with reference to figures 1 to 4.

[0068] As illustrated in [Fig. 1] and [Fig. 2], the control device 1000 according to the invention allows for the management of the flow circulating in the lumen L of a vas deferens C of a male individual. The control device 1000 comprises a clamp 100 configured to coaxially grasp an outer wall of the vas deferens C along an axis F of the lumen L, and a long element 10, adapted to be coupled to the clamp 100, a distal portion 11 of which is adapted to be at least partially inserted into the vas deferens C.

[0069] The long element 10 shown in different positions in figures 1 to 4, includes a distal part 11 suitable for being introduced at least partially into the vas deferens C along an axis perpendicular to the axis F and which has dimensions adapted to be introduced at the level of the lumen L so that the mucosa of the vas deferens C serves as a natural seal.

[0070] Thus, the distal part 11 of the elongated element 10 presents: - a through-hole 12 shown in [Fig. 1] where clamp 100 is in the closed position and in [Fig. 3] where clamp 100 is in the open position, capable of allowing flow along axis F when the opening 12 is aligned with the lumen L in the fertility mode, and - a diverting tube 13 shown in [Fig. 1] and [Fig. 2] where the clamp 100 is in the closed position and in [Fig. 4] where the clamp is in the open position, capable of diverting said flow out of the vas deferens C when an inlet 13b, visible in [Fig. 1] and [Fig. 4], of said diverting tube 13 is aligned with the lumen L in the contraceptive mode.

[0071] The diverting tube 13 extends between the distal part 11 and the proximal part 14 of the elongated element 10 and has an outlet opening at said proximal part 14 which forms a head abutting a blocking means 107, 108.

[0072] Furthermore, as illustrated in [Fig. 1B], the through opening 12 and the inlet 13b of the diverter pipe 13 are advantageously connected. In this embodiment, they are also arranged directly opposite each other.

[0073] In order to couple the elongated element 10 to the clamp 100, the clamp 100 advantageously has: - a locking means 107, 108 in the form of a keying shoe having a perforation (not shown), disposed at the external surface 101a of the gripper 100 at the level of the first jaw 102, and - a through bore (not shown) in alignment with the perforation (not shown) of the locking means 107, 108, also disposed at the level of the first jaw 102, so that the long element 10 can be inserted simultaneously through the perforation and the bore at the level of the first jaw 102 and coupled to the clamp 100, while being blocked in translation and rotation by means of at least one notch 108.

[0074] The clamp 100 is configured to coaxially grip the outer wall of the vas deferens C visible in [Fig. 2]. For this purpose, the pair of jaws 102, 103, in the closed position, has an air gap E at the free end of the clamp 100 that is smaller than the diameter of the vas deferens C. The pair of jaws 102, 103 of the clamp 100 is movable between an open position shown in [Fig. 3] and [Fig. 4] and a closed position shown in [Fig. 1] and [Fig. 2] in which the inner surfaces The first 102 and second 103 jaws, respectively, each come into contact with the outer wall of the vas deferens C. The first 102 and second 103 jaws constitute arched lamellae adapted to each come into contact with the outer wall of the vas deferens C, so that the pair of jaws 102, 103 presents, in the closed position, an elliptical profile in the plane perpendicular to the axis F.

[0075] In the described embodiment, the body 101 of the clamp 100 is essentially U-shaped and constitutes an elastic hinge connecting the first 102 and second 103 jaws, which are movable between a passive open position in which the clamp is mechanically at rest and an active closed position in which the clamp 100 is subjected to restoring forces that tend to return it to the passive open position.

[0076] In order to secure and mechanically reinforce the device 1000, the clamp 100 includes a locking means 104, 106 configured to temporarily immobilize the pair of jaws 102, 103 in the closed position gripping the vas deferens C.

[0077] The locking means 104, 106 includes a hooking means 104 in the form of a hook and a receiving means 106 in the form of a rod comprising a groove cooperating by overlapping and blocking by opposing forces the return to the open passive position.

[0078] Also, the clamp 100 includes at least one actuation means 105 in the form of a trigger configured to release the locking means 104, 106 when it holds the device in the closed position, for example by the exercise of pressure.

[0079] In the currently described variant of the device 1000, the receiving means 106 of the locking means 104, 106 and the actuating means 105 form a single unit, which allows the device to be optimized in terms of compactness and / or number of parts.

[0080] Furthermore, the locking means 104, 106 and the actuating means 105 are disposed on the internal surface 101b, i.e. in the internal space of the clamp 100, with reference to [Fig. 2]. Thus, the receiving means 106 is disposed on the internal surface 101b of the first arm of the U-shaped hinge 101 associated with the first jaw 102, and the hooking means 104 is disposed on the internal surface 101b at the free end disposed in the internal space of the clamp 100 relative to the second jaw 103.

[0081] Thanks to all these characteristics, the practitioner can easily and quickly implant or modify the mode of operation of the device 1000 at the level of the vas deferens C of the male subject.

[0082] During the initial implantation, once the tissues have been dissected to expose the canal C, the practitioner grasps the forceps 100 in the open position and clamps the vas deferens C between the jaws 102, 103, applying pressure to the external surface of the forceps 100, for example, to the external surface 101a of the body 101 and / or to the locking means 107, 108 and / or to the second jaw 103, until the locking means 104, 106 is locked in the closed position by overlapping the hook means 104 and the receiver means 106. To complete the implantation procedure, the practitioner then installs and locks the elongated element 10 in the chosen mode, either for contraception or fertility, by inserting and positioning it appropriately through the perforation and bore provided in the first jaw. 102 and the blocking means 107, 108. Then simply close the fabrics.

[0083] If the operating mode needs to be changed, and as many times as necessary or desired, the practitioner simply needs to reopen the tissues, remove the elongated element 10 from the clamp 100, which can remain in the closed position around the vas deferens C, and reinsert it in the new, appropriate position before closing the tissues. The presence of at least one error-proofing means 108 makes this task particularly easy.

[0084] Finally, to proceed with the final extraction of the device 1000, the practitioner simply needs to open the tissues, possibly extract the long element 10 from the clamp 100, and perform an appropriate action such as applying pressure to the actuating means 105 to cause the opening of the locking means 104, 106 and the passage of the clamp 100 from the closed position to the open position releasing the vas deferens C, and then close the tissues.

[0085] It is easily understood that this detailed description relates to a particular example of the realization and implementation of the present invention, but that in no way does this description have any limiting character to the object of the invention; on the contrary, its objective is to remove any possible imprecision or misinterpretation of the following claims.

[0086] Thus, it will be understood that the examples of clamp 100, long element 10, locking means 107, 108, locking means 104, 106 and actuating means 105 presented can vary considerably in their form and structure according to the requirements.

[0087] Similarly, the reference signs placed in parentheses in the following claims are in no way intended to be limiting; these signs are solely intended to improve the intelligibility and understanding of the following claims and the scope of the protection sought.

Claims

Demands

1. A control device (1000) for a flow circulating in the lumen (L) of a vas deferens (C) of a male individual, comprising: - a clamp (100) configured to coaxially grip an outer wall of the vas deferens (C) along an axis of the lumen F; and - a long element (10), coupled to the clamp (100), a distal portion (11) of which is able to be introduced at least partially into the vas deferens (C) and has a deflection tube (13, 13b) able to deflect said flow out of the vas deferens (C) when an inlet (13b) of said deflection tube (13) is aligned with the lumen (L).

2. Device (1000) according to claim 1, wherein the distal part (11) of the long element (10) is able to be introduced into the lumen (L) of the vas deferens (C) along an axis perpendicular to the axis F.

3. Device (1000) according to any one of the preceding claims, wherein the long element (10) has a through opening (12) capable of allowing the flow to pass along the axis F when the opening (12) is aligned with the light (L).

4. Device (1000) according to any one of the preceding claims, wherein the clamp (100) comprises a pair of jaws (102, 103) movable between an open position and a closed position in which the inner surfaces (101b) respectively of the first and second jaws each come into contact with the outer wall of the vas deferens (C).

5. Device (1000) according to the preceding claim, wherein the first and second jaws (102, 103) are connected by an elastic hinge (101).

6. Device (1000) according to any one of the preceding claims, wherein the clamp (100) includes a locking means (104, 106) in the closed position.

7. Device (1000) according to any one of the preceding claims, wherein the clamp (100) is essentially U-shaped (101), the first and second jaws (102, 103) being disposed respectively at the free end of the first and second branches of the U (101).

8. Device (1000) according to any one of claims 6 or 7, wherein the locking means (104, 106) is capable of holding the device (1000) in the active closed position and comprises a hooking means (104) and a receiving means (106) cooperating by overlapping and blocking by opposing forces the return to the passive open position.

9. Device (1000) according to any one of claims 6 to 8, wherein the clamp (100) includes an actuating means (105) configured to release the locking means (104, 106) when it holds the device (1000) in the closed position.

10. Device (1000) according to any one of the preceding claims, wherein the diverting tube (13, 13b) extends between the distal part (11) and the proximal part (14) of the long element (10) and has an outlet opening at said proximal part (14).

11. Device (1000) according to any one of claims 4 to 10, wherein the first jaw (102) has a bore at which the long element (10) is coupled to the clamp (100).

12. Device (1000) according to any one of the preceding claims, wherein the clamp (100) includes at least one locking means (107, 108) for the long element (10), such as a keying shoe.

13. Device (1000) according to claims 11 and 12, wherein the bore passes through the first jaw (102), wherein the locking means (107, 108) is disposed at the external surface (101a) at the level of the first jaw (102) and has a perforation in alignment with said bore, and wherein the proximal part (11) of the longitudinal element (10) forms a head (14) adapted to come into contact with the locking means (107, 108) when the longitudinal element (10) is inserted through the perforation and the bore.

14. Device (1000) according to any one of claims 4 to 13, wherein the pair of jaws (102, 103) has in closed position an elliptical profile in the plane perpendicular to the axis F.

15. Device (1000) according to any one of claims 4 to 14, wherein the pair of jaws (102, 103) has in the closed active position an air gap (E) smaller than the diameter of the vas deferens (C).

16. Device (1000) according to any one of the preceding claims, wherein the distal part (11) of the elongated element (10) comprises a tapered end.

17. Device (1000) according to any one of claims 3 to 16, wherein the through opening (12) and the inlet (13b) of the diverter tube (13, 13b) are communicating.

18. Device (1000) according to any one of the preceding claims, wherein the deflection tube (13, 13b) includes a means for closing the flow when the through opening (12) is aligned with the axis F.

19. Device (1000) according to any one of the preceding claims, which is made of polyetheretherketone.

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