Testicular Fertility Control Implant

Abstract

FERTILITY CONTROL TESTICULAR IMPLANT The present invention relates to a testicular implant, and more particularly to a testicular implant for use in men. Figure from the abstract: [Fig. 1]

Description

Title of the invention: Testicular Fertility Control Implant FIELD OF INVENTION

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

[0002] Fertility management, and more specifically contraception, is a significant issue. Indeed, 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 concern female contraception. Male contraception methods also exist, including: a. Condoms, which form a physical barrier preventing sperm from reaching the egg. However, there is a risk of condom breakage, and it is necessary to use a condom for every sexual act. b. Vasectomy, which is a sterilizing surgical procedure that cuts or blocks the vas deferens to prevent sperm from reaching the semen. However, this operation is invasive and usually 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 female contraceptive methods.

[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 is often achieved through surgical castration, an invasive and irreversible procedure that can lead to consequences such as behavioral changes or health complications.

[0004] There is therefore a need to provide improved means of contraception which are free, at least in part, from the disadvantages mentioned above. SUMMARY

[0005] The present description relates to a testicular implant comprising an ovoid-shaped implant body extending along an axis, the implant body having a face external, a base, a housing, and an opening configured to open into the housing, in which a. The socket 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 while leaving the epididymis free, and in which the implant includes a contraceptive device configured to limit the fertility of the testicle.

[0006] In the present description, fertility refers to the ability of the testes to provide gametes capable of reproduction. Limiting fertility therefore consists of reducing the number of gametes or damaging them, so that the testes, under the influence of a contraceptive device, are less capable of producing gametes capable of reproduction, compared to a situation where the testes are not under the influence of said contraceptive device.

[0007] The implant of the present invention provides a long-lasting means of contraception, which 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 implanted in an animal without difficulty and makes it possible to reduce, or even stop, the animal's fertility. The implant of the present invention can therefore be used for both animals and humans.

[0009] Furthermore, the present implant can be removed from a patient or animal in which said implant has been implanted. Consequently, the implant of the present invention is a reversible means of contraception. Indeed, since the implantation of the implant does not cause any 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 provides protection and stability to the contraceptive device. Consequently, the risks of damage to the contraceptive device and to 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 allows for the measurement of physiological variables. On the other hand, the control unit allows for the interpretation of the physiological variables measured by the sensor. It then becomes possible to take into account physiological variables in the action of the contraceptive device.

[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, i.e., limit 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. Thus, when the contraceptive device includes a heating system, the device is capable of raising the temperature of the testicles and inhibiting spermatogenesis.

[0021] In the context of animal contraception, the contraceptive device may allow the testicles to be maintained at a suitable temperature for limiting 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 generate 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 means of contraception.

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

[0025] The insulating membrane makes it easier to heat the system, and therefore makes it easier to maintain the testicles at a temperature sufficient to inhibit spermatogenesis.

[0026] Furthermore, the insulating membrane can passively suffice on its own to maintain the testicles at a temperature sufficient to inhibit spermatogenesis. Indeed, providing an insulating membrane allows the body temperature to be used to maintain the testicles at normal body temperature (namely 37°C), which inhibits 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 envelop the testicle when the implant accommodates a testicle in its housing.

[0031] Such a placement of the resistive wires makes it possible to obtain homogeneous heating of the testicles, which improves the inhibition of spermatogenesis.

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

[0033] In some embodiments, the heating system is controlled by the control unit and in which the control unit controls 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 reliability of contraception provided by 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 inhibiting spermatogenesis of 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 continued function. 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 charging system without thread.

[0040] The wireless battery charging method ensures that the contraceptive device can be recharged without the implant needing to be removed. Implant maintenance is therefore simplified.

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

[0042] The present description also relates to a male contraception system comprising: a. a testicular implant comprising an ovoid-shaped 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, with the implant enveloping the testicle while leaving the epididymis free, and iii. The implant comprises a contraceptive device configured to limit testicular fertility, the contraceptive device comprising a control unit and b. an external control interface capable of controlling the control unit of the contraceptive implant device.

[0043] 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.

[0044] 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.

[0045] In some embodiments, the control interface includes a user interface.

[0046] The present exposition also relates to a surgical method comprising anesthesia, asepsis, a surgical intervention in which an implant according to one of the previous aspects is implanted in a patient and, optionally, post-operative care. BRIEF DESCRIPTION OF THE FIGURES

[0047] [Fig.1] Fig.1 schematically represents a testicular implant according to a first embodiment.

[0048] [Fig.2] Fig.2 schematically represents the testicular implant of the embodiment of Fig.1 arranged around a human testicle.

[0049] [Fig.3] Fig.3 schematically represents a view from below of the testicular implant of the first embodiment.

[0050] [Fig.4] The [Fig.4] is a diagram illustrating the interactions between the different elements of the testicular implant according to the embodiment of the [Fig.1].

[0051] [Fig.5] The [Fig.5] schematically a testicular implant according to a second embodiment, comprising an insulating membrane. DETAILED DESCRIPTION

[0052] Examples of embodiments are described in this document. The invention is not limited to these examples.

[0053] Figure 1 schematically represents a testicular implant 10 according to one embodiment. The implant 10 comprises an implant body 18 of ovoid shape extending along an axis X. In other words, the implant has a truncated oval shape, similar to an eggshell.

[0054] 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.

[0055] 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 Å 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.

[0056] The housing 12 is suitable for receiving a testicle. In particular, the housing 12, and more generally the 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. The implant 10 can be manufactured by molding in medical-grade silicone, followed by vulcanization. Vulcanization strengthens the structure of the implant 10.

[0057] In the present embodiment, the implant 10 accommodates a human testicle. With reference to [Fig. 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 a testicle of a standing patient, the X direction corresponds to the direction of gravity.

[0058] [Fig.2] schematically represents the testicular implant of the embodiment of [Fig. 1] arranged around a human testicle. As can be seen in [Fig. 2], the implant 10 is configured so that the implant body 18 is placed between the testicle and scrotum, the implant enveloping the testicle while leaving the epididymis free 100.

[0059] The implant 10 includes a contraceptive device 50 configured to limit testicular fertility. In the embodiment shown in [Fig. 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 resistive wire network 56 are electrically connected and together form the heating system. The heating system may include other elements. The battery may be a lithium-ion battery or any other type of battery suitable for storing electrical energy.

[0060] Although the present 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.

[0061] 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.

[0062] 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 housing 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.

[0063] 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.

[0064] 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 passage 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.

[0065] Figure 3 schematically represents a bottom view of the testicular implant of the first embodiment. For clarity, a portion of the resistive wires of the resistive wire network 56 is omitted.

[0066] Figure 4 is a diagram illustrating the interactions between the different elements of the testicular implant 10 according to the embodiment of 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.

[0067] The control unit 54 is configured to receive the physiological variables measured by the sensor 58. Under these circumstances, the control unit 54 is capable of regulating 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.

[0068] On the other hand, the control unit 54 may include a communication module 541 capable of communicating with an external control interface 542. The communication may 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 may 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 may, for example, be carried out by radio frequency.

[0069] 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.

[0070] 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.

[0071] The battery 52 includes a wireless charging system 521 configured to allow the battery 52 to be recharged without a wired connection to a power source. For example, the wireless charging system 521 may allow the battery 52 to be recharged wirelessly by an inductive method or by magnetic resonance.

[0072] 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 resistive wires 56. The insulating membrane 500 can also be self-sufficient and provide contraception for the implant 10 on its own. In these circumstances, the insulating membrane 500 is a passive heating system, which is not electrical.

[0073] 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 manufacture of the implant 10.

[0074] The insulating membrane 500 is disposed, preferably entirely, inside the implant body 18. The insulating membrane 500 extends into 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 can, like the implant body 18, have an ovoid shape extending along an axis X. In other words, the insulating membrane 500 can have a truncated oval shape, similar to an eggshell.

[0075] The present implant 10 can be implanted in a patient using a surgical method comprising anesthesia, asepsis, a surgical procedure, and postoperative care. The patient is preferably positioned dorsal during the surgical method, and more specifically during the surgical intervention.

[0076] First, the patient is anesthetized by general or local anesthesia. In the case of local anesthesia, the patient is anesthetized at least at the level of the testicles.

[0077] Next, before the surgical procedure, asepsis is carried out in order to maintain a sterile state throughout the duration of the surgical procedure and to avoid any contamination of the patient.

[0078] 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 makes the incision sufficiently wide to allow for the atraumatic exteriorization of the testicle and to permit its intrascrotal reinsertion into the scrotum, attached to the implant 10, at the end of the surgical procedure.

[0079] Next, the testicle, within its tunic vaginalis, is exteriorized. The various layers covering the tunic 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, for example, be performed using cold scissors and / or an electrocautery device.

[0080] The vaginal tunic is opened, so as to free the testicle and epididymis, which are then mobilized and exteriorized. At this stage, a complete inspection and palpation can be performed.

[0081] 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 while leaving the epididymis free. The orientation of the implant is verified by the surgeon using the orientation element 16 palpable on the implant 10.

[0082] 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 4 / 0 non-absorbable monofilament thread, is then passed through the fixation holes 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.

[0083] Before reinserting the testicle, encased by the implant 10, into the scrotum, an atraumatic preparation of the pocket is performed using a finger. This preparation ensures the creation of a suitable pocket to receive the testicle and its implant without risk of compression or torsion.

[0084] The testicle, enveloped by the implant 10, is then inserted into the pocket thus created, the position of the implant 10 is checked, and the incised areas are sutured. The dartos muscle can, for example, 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.

[0085] Post-operative care may include the application of a dry dressing to the scar, for example for a few days, followed by exposure of the scar to air. Optionally, a compression dressing may be used.

Claims

Demands

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 testis, the testis 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 leaving the epididymis (100) free, and wherein the implant (10) includes a contraceptive device (50) configured to limit the fertility of the testicle.

2. 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.

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

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

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

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

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

8. Implant according to claim 7, wherein the heating system is controlled by the control unit (54) and wherein the control unit (54) slaves the heating system to a loop of temperature feedback to a set temperature for the testicle.

9. 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 external face, a base (19), a housing (12), and an opening (14) configured to open onto the housing (12), in which i. 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, 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 testicular fertility, the contraceptive device comprising a control unit and b. an external control interface (542) capable of controlling the control unit (54) of the contraceptive device of the implant.

10. Contraceptive system according to claim 9, in which a. The implant (10) includes 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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