Testicular implant for fertility control

Abstract

The present invention relates to a testicular implant and, more specifically, a testicular implant intended for men.

Description

Testicular fertility control implant - Scope of the invention

[0001] The present invention relates to a testicular implant, and more particularly to a testicular implant with contraceptive capabilities for men. PRIORITY OF THE TECHNOLOGY

[0002] Fertility management, and more specifically contraception, is a crucial issue. Human contraception allows for intimacy without procreation, while animal contraception is a tool for livestock farmers. Regarding human contraception, several methods are known, but the most widespread are those for women. Male contraception methods also exist, including: a. Condoms, which create a physical barrier preventing sperm from reaching the egg. However, there is a risk of condom breakage, and a new condom must be used for every sexual encounter. b. Vasectomy, a sterilizing surgical procedure that cuts or blocks the vas deferens to prevent sperm from reaching the semen. However, this operation is invasive and generally irreversible. c.Hormonal treatments, which are based on the use of hormones to reduce sperm production. However, this method can have side effects and is less reliable than comparable methods of female contraception.

[0003] On the other hand, human contraception, with the exception of vasectomy, cannot be directly applied to animal contraception. This is because human hormonal cycles differ from those of animals, and condoms are not suitable for animal use. Furthermore, contraception... In animals, castration is often performed by surgical castration, an invasive and irreversible procedure that can lead to consequences such as behavioral changes or health complications.

[0004] Therefore, there is a need to provide improved methods of contraception that are at least partially free of the drawbacks mentioned above. SUMMARY

[0005] The present exposition relates to a testicular implant comprising an ovoid implant body extending along an axis, the implant body having an external face, a base, a housing, and an opening configured to open onto the housing, in which a. the housing is suitable for receiving a testicle, the testicle comprising a postero-superior border connected to the epididymis and a free antero-inferior border facing the scrotum, b. the implant body is configured to be placed between the testicle and the scrotum, the implant enveloping the testicle leaving the epididymis free, and in which the implant comprises a contraceptive device configured to limit the fertility of the testicle.

[0006] In this discussion, fertility refers to the testicles' ability to produce gametes suitable for reproduction. Limiting fertility therefore consists of reducing the number of gametes or damaging them, so that the testicles, under the influence of a contraceptive device, are less able to produce gametes suitable for reproduction, compared to a situation where the testicles are not under the influence of said contraceptive device.

[0007] The implant of the present invention provides a long-lasting method of contraception that remains effective for an extended period, even as long as the implant is in place in the patient. Thus, the present implant is more effective than a condom, which is for single use only.

[0008] Furthermore, such an implant can be easily implanted in an animal and can reduce, or even stop, the animal's fertility. The implant of the present invention can therefore be used in both animals and humans.

[0009] Furthermore, the present implant can be removed from a patient or animal in which it has been implanted. Therefore, the implant of the present invention is a reversible contraceptive method. Indeed, since the implantation of the implant causes no damage to the testicle, its removal presents only an extremely limited risk of permanent sterilization.

[0010] In some embodiments, the contraceptive device is disposed, preferably entirely, inside the implant body.

[0011] When the contraceptive device is inside the implant body, the implant body protects and stabilizes the device. Consequently, the risks of damage to both the contraceptive device and the patient are reduced.

[0012] In some embodiments, the implant includes at least one control unit and a sensor connected to the control unit, the sensor being configured to measure physiological variables.

[0013] The sensor measures physiological variables. The control unit then interprets these measured physiological variables. This allows the contraceptive device to take these physiological variables into account.

[0014] Furthermore, when the sensor is placed entirely inside the implant, it is better isolated from the external environment. Consequently, the sensor measurement is less sensitive to noise and is more accurate and reliable.

[0015] Furthermore, if the control unit is capable of controlling the contraceptive device, contraception is reversible and can be activated or discontinued without removing the implant. In other words, contraception can be controlled simply by activating or deactivating the contraceptive device.

[0016] In some embodiments, the control unit is disposed, preferably entirely, in the implant body, at the level of the base of the implant body.

[0017] When the control unit is located within the implant body, the implant body provides protection for the control unit. Furthermore, positioning the control unit at the base is particularly advantageous in terms of integration within the implant.

[0018] In some embodiments, the contraceptive device includes a heating system.

[0019] In humans, the optimal temperature for spermatogenesis is 2 to 3°C lower than normal body temperature (37°C). An increase in testicular temperature can inhibit or stop sperm production, thus limiting testicular fertility. Naturally, the scrotum regulates testicular temperature through mechanisms such as the dilation or contraction of blood vessels and the positioning of the testes closer to or further from the body.

[0020] In other words, raising the temperature of the testicles inhibits spermatogenesis and provides effective contraception. Therefore, when a contraceptive device includes a heating system, it is capable of raising the temperature of the testicles and inhibiting spermatogenesis.

[0021] In the context of animal contraception, the contraceptive device can allow the testicles to be maintained at a suitable temperature to limit the fertility of said animal.

[0022] Furthermore, this type of contraception does not involve any hormonal action. Consequently, this method of contraception greatly limits the occurrence of side effects, and may even produce no side effects at all.

[0023] The heating system can be the sole means of contraception provided by the contraceptive device and offer effective contraception. However, the contraceptive device may include other methods of contraception.

[0024] In some embodiments, the heating system includes an insulating membrane.

[0025] The insulating membrane facilitates heating by the heating system, and therefore helps maintain the testicles at a temperature sufficient to inhibit spermatogenesis.

[0026] Furthermore, the insulating membrane can passively maintain the testicles at a temperature sufficient to inhibit spermatogenesis. Indeed, providing an insulating membrane allows the body's temperature to be used to keep the testicles at normal body temperature (37°C), thus inhibiting spermatogenesis.

[0027] In some embodiments, the heating system includes an electric heating network.

[0028] In some embodiments, the electric heating network includes resistive wires.

[0029] The use of resistive wires is an easy and effective solution for regulating the temperature of the implant.

[0030] In some embodiments, the resistive wires are placed inside the implant body, so as to wrap around the testicle when the implant accommodates a testicle in its housing.

[0031] Such a placement of the resistive wires allows for homogeneous heating of the testicles, which improves the inhibition of spermatogenesis.

[0032] In some embodiments, the sensor is configured to measure testicular temperature.

[0033] In some embodiments, the heating system is controlled by the control unit and in which the control unit slaves the heating system to a temperature feedback loop at a setpoint temperature for the testicle.

[0034] Temperature control ensures a more reliable temperature for the testicles, thereby improving the reliability of spermatogenesis inhibition. Consequently, the contraceptive effectiveness of the testicular implant is enhanced.

[0035] In the context of animal contraception, the heating system can be adapted to maintain the testicles at a temperature that inhibits spermatogenesis in said animal.

[0036] In some embodiments, the electric heating network includes a battery.

[0037] The battery allows the testicular implant to operate autonomously, thus ensuring its long-term effectiveness. Maintenance of the implant is therefore less demanding.

[0038] In some embodiments, the battery is a lithium-ion battery.

[0039] In some embodiments, the battery includes a wireless charging system.

[0040] The wireless battery charging method ensures that the contraceptive device can be recharged without removing the implant. This simplifies implant maintenance.

[0041] In some embodiments, the implant body is made of silicone.

[0042] In some embodiments, the implant further comprises a neuromuscular electrical stimulation module disposed within the implant body and including at least one electrode capable of stimulating at least one erectile nerve.

[0043] Such an implant thus offers a complementary therapeutic benefit to fertility control, particularly in patients with moderate erectile dysfunction or with a view to post-operative rehabilitation.

[0044] The present presentation also relates to a male contraceptive system comprising: a. a testicular implant comprising an ovoid implant body extending along an axis, the implant body having an external face, a base, a housing, and an opening configured to open onto the housing, in which i. the housing is suitable for receiving a testicle, the testicle comprising a postero-superior border connected to the epididymis and a free antero-inferior border facing the scrotum, ii. the implant body is configured to be placed between the testicle and the scrotum, the implant enveloping the testicle while leaving the epididymis free, and iii. the implant comprises a contraceptive device configured to limit the fertility of the testicle, the contraceptive device comprising a control unit and b. an external control interface suitable for controlling the control unit of the contraceptive device of the implant.

[0045] The contraceptive system according to the invention allows the user of the implant to manage their contraception independently by directly controlling the implant from the control interface.

[0046] In some embodiments the implant includes a sensor configured to measure physiological variables, and the control interface is configured to receive the physiological variables measured by the sensor.

[0047] In some embodiments, the control interface includes a user interface.

[0048] This presentation also concerns a surgical method comprising anesthesia, asepsis, a surgical procedure in which an implant, according to one of the preceding aspects, is implanted in a patient, and optionally, postoperative care. BRIEF DESCRIPTION OF FIGURES

[0049] Figure 1 schematically represents a testicular implant according to a first embodiment.

[0050] Figure 2 schematically represents the testicular implant of the embodiment of Figure 1 arranged around a human testicle.

[0051] Figure 3 schematically represents a bottom view of the testicular implant of the first embodiment.

[0052] Figure 4 is a diagram illustrating the interactions between the different elements of the testicular implant according to the embodiment of Figure 1.

[0053] Figure 5 schematically depicts a testicular implant according to a second embodiment, including an insulating membrane. DETAILED DESCRIPTION

[0054] Examples of implementation are described in this document. The invention is not limited to these examples.

[0055] Figure 1 schematically represents a testicular implant 10 according to one embodiment. The implant 10 comprises an ovoid implant body 18 extending along an axis X. In other words, the implant has a truncated oval shape, similar to an eggshell.

[0056] The implant body 18 has an external face, a base 19, a housing 12, and an opening 14 configured to open onto the housing 12.

[0057] The implant body 18 can be made of any biocompatible material with very low hardness. A material is considered to have very low hardness if its hardness is less than 55,000, 40,000, or 7 A on the Shore scale. This very low hardness ensures the material's flexibility and strength. For example, the implant body 18 can be made of silicone.

[0058] Slot 12 is suitable for housing a testicle. In particular, slot 12, and more generally implant 18, can be sized to accommodate a human testicle or an animal testicle, for example, a bovine testicle. For human use, several implant sizes can be provided to accommodate the anatomical variations of different patients. Implant 10 can be manufactured by molding in medical-grade silicone, followed by vulcanization. Vulcanization strengthens the structure of implant 10.

[0059] In this embodiment, the implant 10 accommodates a human testicle. Referring to Figure 2, the human testicle comprises a postero-superior border 101 connected to the epididymis 100 and a free antero-inferior border 102, which faces the scrotum. It should also be noted that, when the implant 10 is positioned around the testicle of a standing patient, the X direction corresponds to the direction of gravity.

[0060] Figure 2 schematically represents the testicular implant of the embodiment of Figure 1 positioned around a human testicle. As can be seen in Figure 2, the implant 10 is configured so that the implant body 18 is placed between the testicle and the scrotum, the implant enveloping the testicle while leaving the epididymis 100 free.

[0061] The implant 10 includes a contraceptive device 50 configured to limit testicular fertility. In the embodiment shown in Figure 1, the contraceptive device 50 includes a heating system. In this example, the heating system is electric and comprises a resistive wire network 56, a battery 52, and a control unit 54. More specifically, the battery 52, the control unit 54, and the... A network of 56 resistive wires are electrically connected together to form the heating system. The heating system may include other components. The battery can be a lithium-ion battery, or any other type of battery capable of storing electrical energy.

[0062] Although this description uses the example of a contraceptive device 50 as an electrical device based on a network of resistive wires 56, other contraceptive devices 50 may be provided, using other contraceptive mechanisms. For example, the contraceptive device 50 may include a hormone diffuser capable of inhibiting spermatogenesis.

[0063] The heating system is located inside, preferably entirely inside, the implant body 18. The battery 52 and the control unit 54 are positioned at the base 19 of the implant body 18. For this purpose, the implant may include an increased thickness at the base 19 to ensure better protection of the battery 52 and the control unit 54. Optionally, the contraceptive device 50 may be embedded in a polymer matrix, which may be made of medical-grade silicone or polyurethane, or a material identical to the implant body 18.

[0064] On the other hand, the resistive wire network 56 extends throughout the entire volume of the implant body 18, so as to envelop the testicle when the implant accommodates a testicle in its socket 12. For example, the resistive wire network 56 extends in a spiral or zigzag pattern inside the implant body 18. Furthermore, the wires of the resistive wire network 56 can have a diameter of 0.2 mm and can be directly integrated into the implant body 18 during the molding of the implant 10. Such integration ensures better adhesion and homogeneous heating.

[0065] The battery 52, electrically connected to the resistive wire network 56, is capable of delivering an electric current to the resistive wire network 56. The resistive wire network 56 is configured to heat up when an electric current passes through it. For example, the heating can be achieved by the ohmic effect, induced by the electrical resistance of the resistive wires.

[0066] On the other hand, the control unit 54 is configured to control the battery 52 and / or the resistive wire network 56 so as to allow or prevent the flow of current through the resistive wire network 56. For example, the control unit 54 can be configured to control a switch provided between the battery 52 and the resistive wire network so as to allow or prevent the flow of current from the battery 52 into the resistive wire network 56. More generally, the control unit 54 is capable of controlling the battery 52 and the resistive wire network 56, and the various elements of the contraceptive device 50, to activate or deactivate contraception.

[0067] Figure 3 schematically represents a bottom view of the testicular implant of the first embodiment. For clarity, part of the resistive wires of the resistive wire network 56 is omitted.

[0068] Figure 4 is a diagram illustrating the interactions between the different elements of the testicular implant 10 according to the embodiment shown in Figure 1. Figure 4 thus schematically represents the operation of the contraceptive device 50 of the testicular implant 10. The implant 10 includes a sensor 58 connected to the control unit 54. The sensor 58 is configured to measure physiological variables, preferably at the level of the testicles. For example, the sensor 58 may be capable of measuring testicular temperature. The sensor 58 may be configured to measure other physiological variables, such as, for example, blood glucose levels. In these circumstances, the testicular implant 10 may include a plurality of sensors 58, each specialized in measuring a particular physiological variable.

[0069] The control unit 54 is configured to receive the physiological variables measured by the sensor 58. Under these circumstances, the control unit 54 is able to regulate the contraceptive device 50 according to the physiological variables measured by the sensor 58. In the example of the first embodiment, the sensor 58 is configured to measure the temperature of the testicles, and the control unit 54 is configured to regulate the temperature of the contraceptive device 50 by controlling the action of the battery 52 and the resistive wire network 56 so as to maintain the testicles at a set temperature. Thus, the contraceptive implant 10 can maintain the testicles at a temperature that inhibits spermatogenesis.

[0070] On the other hand, the control unit 54 may include a communication module 541 capable of communicating with an external control interface 542. This communication can be wireless, such as a Wi-Fi or Bluetooth connection. The implant 10 and the external control interface 542 together form a male contraception system. The external control interface 542 is capable of controlling the control unit 54. In particular, the external control interface 542 can be configured to control the control unit 54 so that the control unit 54 controls the battery 52 and the resistive wire network 56 to activate or deactivate contraception. Communication between the communication module 541 and the external control interface 542 can, for example, be via radio frequency.

[0071] The external control interface 542 can, for example, be integrated into a smartphone via a dedicated application, or be a simple remote-controlled device, separate from the implant 10. Furthermore, the external control interface 542 can include a user interface facilitating interaction between the user of the implant 10 and the implant 10. In addition, the external control interface 542 can display the physiological variables measured by the sensor(s) 58.

[0072] In other words, a user can choose to activate or deactivate, from the external control interface 542, the contraception provided by the contraceptive device 50. For example, the user can activate or deactivate the heating system.

[0073] Battery 52 includes a wireless charging system 521 configured to allow charging of Battery 52 without a wired connection to a power source. For example, the wireless charging system 521 can allow wireless charging of Battery 52 using either an inductive or magnetic resonance method.

[0074] Figure 5 schematically shows a testicular implant 10 according to a second embodiment, comprising an insulating membrane 500. Although Figure 5 shows a testicular implant 10 comprising only an insulating membrane 500, the insulating membrane 500 can be used in combination with another contraceptive device 50. For example, the insulating membrane 500 can be coupled to a contraceptive device 50 according to the first embodiment, comprising a network of threads! resistives 56. The insulating membrane 500 can also be self-sufficient and provide contraception for implant 10 on its own. In these circumstances, the insulating membrane 500 is a passive heating system, which is not electrical.

[0075] The insulating membrane 500 is made of a thermally insulating material. Typically, the insulating membrane 500 can be made of a thermally insulating material such as aerogel or neoprene. The thickness of the insulating membrane 500 can be 1 mm. The insulating membrane 500 can be integrated directly into the implant body 18 during the manufacturing of the implant 10.

[0076] The insulating membrane 500 is preferably entirely located inside the implant body 18. The insulating membrane 500 extends within the implant body 18 so as to envelop the testicle when a testicle is received in the housing 12 of the implant 10. Thus, the insulating membrane 500, like the implant body 18, can have an ovoid shape extending along an X axis. In other words, the insulating membrane 500 can have a truncated oval shape, similar to an eggshell.

[0077] In some embodiments omitted from the figures, the implant 10 further comprises a neuromuscular electrical stimulation module disposed in the implant body 18 and including at least one electrode capable of stimulating at least one erectile nerve.

[0078] This module can operate by transcutaneous electrical nerve stimulation (TENS), allowing to promote erection by local neuromodulation.

[0079] This module can be controlled by the control unit 54 and / or by the external control interface 542. The control unit 54 and / or the external control interface 542 coupled with the neuromuscular electrical stimulation module forms a TENS stimulation system.

[0080] The present implant 10 can be implanted in a patient using a surgical method involving anesthesia, asepsis, surgery, and postoperative care. The patient is preferably positioned supine during the surgical method, and particularly during the surgery itself.

[0081] First, the patient is anesthetized with general or local anesthesia. In the case of local anesthesia, the patient is anesthetized at least in the testicles.

[0082] Next, before the surgical procedure, asepsis is performed in order to maintain a sterile state throughout the duration of the surgical procedure and to avoid any contamination of the patient.

[0083] The surgical procedure is performed as follows. First, a single vertical skin incision is made along the median scrotal raphe, for example, using a No. 15 cold blade. The incision can be made by resting it on the testicular bolster held under tension between two of the surgeon's fingers and typically extends for 4 to 5 cm. This incision is wide enough to allow for the atraumatic exteriorization of the testicle and to permit its intrascrotal reinsertion, attached to the implant, at the end of the surgical procedure.

[0084] Next, the testicle, within its tunica vaginalis, is exposed. The various layers covering the tunica vaginalis, such as the dartos muscle, the subcutaneous cellular tunic, the external spermatic fascia, and the deep fibrous tunic, are incised, isolated, and then electrocoagulated. These procedures can be performed, for example, using cold scissors and / or an electrocautery device.

[0085] The vaginal tunic is opened to free the testicle and epididymis, which are then mobilized and externalized. At this stage, a complete inspection and palpation can be performed.

[0086] The testicle is then inserted into the socket 12 of the implant 10 through the opening 14 of the implant 10. The implant 10 is then positioned so as to partially enclose the testicle, leaving the epididymis free. The orientation of the implant is verified by the surgeon using the orientation element 16, which is palpable on the implant 10.

[0087] The implant 10 can be fixed to the testicle using the optionally provided fixation holes 22 on the implant 10. A suture thread, for example a non-absorbable monofilament 4 / 0 thread, is then passed through the fixation holes so as to suture! the implant 10 to the testicle. Advantageously, the passage of the sutures through the tunica albuginea is minimized, remaining superficial, so as to limit or even avoid any damage to the underlying testicular pulp.

[0088] Before reinserting the testicle, encased in implant 10, into the scrotum, an atraumatic preparation of the pocket is performed digitally. This preparation ensures the creation of a suitable pocket to receive the testicle and its implant without risk of compression or torsion.

[0089] The testicle, enveloped by the implant 10, is then inserted into the pocket thus created, the position of the implant 10 is verified, and the incised areas are sutured. The dartos muscle, for example, can be closed with a running or interrupted suture using 3 / 0 slow-absorbing braided suture. Finally, the scrotal skin is closed with interrupted sutures of 3 / 0 rapid-absorbing monofilament suture.

[0090] Post-operative care may include applying a dry dressing to the scar, for example for a few days, followed by exposing the scar to air. Optionally, a compression dressing may be used.

Claims

CLAIMS 1. Testicular implant (10) comprising an ovoid implant body (18) extending along an axis (X), the implant body (18) having an external face, a base (19), a housing (12), and an opening (14) configured to open onto the housing (12), in which: a. the housing (12) is suitable for receiving a testicle, the testicle comprising a postero-superior border (101) connected to the epididymis (100) and a free antero-inferior border (102) facing the scrotum, b. The implant body (18) is configured to be placed between the testicle and the scrotum, the implant (10) enveloping the testicle while leaving the epididymis (100) free, and wherein the implant (10) includes a contraceptive device (50) configured to limit the fertility of the testicle. 2.

1. Implant according to claim 1, comprising at least one control unit (54) and a sensor (58) connected to the control unit (54), the sensor (58) being configured to measure physiological variables.

2. Implant according to claim 2, wherein the control unit is disposed, preferably entirely, within the implant body (18), at the base (19) of the implant body (18).

3. Implant according to any one of claims 1 to 3, wherein the contraceptive device (50) comprises a heating system.

4. Implant according to claim 4, wherein the heating system comprises an insulating membrane (500).

5. Implant according to any one of claims 4 or 5, wherein the heating system comprises an electric heating network.

6. Implant according to claims 4 to 6 in combination with claim 2, wherein the sensor (58) is configured to measure testicular temperature.

8. An implant according to claim 7, wherein the heating system is controlled by the control unit (54) and wherein the control unit (54) controls the heating system via a temperature feedback loop to a setpoint temperature for the testicle.

9. An implant according to any one of claims 1 to 8, further comprising a neuromuscular electrical stimulation module disposed in the implant body (18) and including at least one electrode capable of stimulating at least one erectile nerve.

10. A male contraceptive system comprising a. a testicular implant (10) comprising an ovoid implant body (18) extending along an axis (X), the implant body (18) having an outer face, a base (19), a housing (12), and an opening (14) configured to open onto the housing (12), wherein i.the housing (12) is adapted to accommodate a testicle, the testicle comprising a postero-superior border (101) connected to the epididymis (100) and a free antero-inferior border (102) facing the scrotum, ii. the implant body (18) is configured to be placed between the testicle and the scrotum, the implant (10) enveloping the testicle while leaving the epididymis (100) free, and iii. wherein the implant (10) comprises a contraceptive device configured to limit the fertility of the testicle, the contraceptive device comprising a control unit and b. an external control interface (542) adapted to control the control unit (54) of the contraceptive device of the implant.

11. Contraceptive system according to claim 9, wherein a. the implant (10) comprises a sensor (58) configured to measure physiological variables, and b. The control interface (542) is configured to receive the physiological variables measured by the sensor (58).

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