Implantable system for injecting substance into patient's body

Abstract

To provide a more reliable and convenient method for administering a substance into a patient.SOLUTION: An at least partly implantable system for injecting a substance into a patient's body, in particular a penis erection stimulation system, comprises one or more infusion needles 11 disposed within the patient's left and right corpora cavernosa and implanted along with one or more housings 12 adjacent to the patient's left and right corpora cavernosa. A reservoir R1 and a pump P are also implanted inside the patient's body to supply the infusion needle with infusion liquid. A drive unit D also adapted for implantation inside the patient's body is arranged for advancing and retracting the tip end of the infusion needle such that it penetrates the housing at least in two different penetration areas either simultaneously or in immediate time succession, thereby injecting drugs along with the infusion liquid into the patient's body for stimulating penis erection.SELECTED DRAWING: Figure 18

Description

[Technical field]

[0001] The present invention relates generally to the infusion of substances, particularly drugs, into the body of a patient, and more particularly to Pertaining to stimulation of the penis to erect. [Background technology]

[0002] When a man is sexually stimulated, the connection between the artery and the vein closes (arteriovenous anastomosis), thus Blood that normally bypasses the corpus cavernosum spaces, or sinuses, pools within the penis.

[0003] The main blood vessel that supplies blood to the cavernous sinuses of the erectile tissue of the corpus cavernosum is the deep penile artery. Therefore, the deep penile artery is closely related to penile erection. The deep penile artery opens directly into the cavernous sinus. When the penis is relaxed, these arteries form a spiral However, parasympathetic stimulation causes the smooth muscle of the spiral artery to contract. In the relaxed state, the spiral arteries straighten out and expand their lumen to allow blood to pass through. The cavernous sinuses of the corpus cavernosum of the penis are expanded by arterial pressure. It compresses the veins coming out of the corpus cavernosum of the penis, and the erect penis becomes larger and harder, resulting in an erection. happens.

[0004] Patients with erectile dysfunction should administer drugs such as papaverine or prostaglandin E1 to the corpus cavernosum of the penis. The injection causes the penis to swell and relax the smooth muscles. A technique under the supervision of a doctor to ensure that the drug is properly injected into each of the corpora cavernosa. The drug takes effect in just about 15 minutes after administration. Repeated pricking of the same body part causes inflammation, which eventually leads to further pricking. It is important to note that the entire procedure may become difficult or even impossible. The drug must usually be mixed together first from dry matter and saline. This is even more cumbersome because the available drugs are stable only when they are dried (and typically Typically, this is only possible if the injection is not performed properly. In some cases, the drug may be transported with the blood to other areas of the patient's body, so proper administration is essential. and medication is important.

[0005] The aforementioned problems are not limited to the administration of drugs to stimulate penile erection. Similar problems occur when a substance It may also occur in other applications where frequent injections are required. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] WO2007 / 051563 Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, the object of the present invention is to make the whole process more reliable and more convenient for the patient. The goal is to improve the delivery of substances to the patient's body so that they are more beneficial to the patient. The aim of this study was to improve stimulation of the penis to achieve an erection. [Means for solving the problem]

[0008] The essence of the invention is a method for administering a substance into a patient's body using at least one implantable injection needle. This eliminates the need for patients to prick themselves with a needle, Patient comfort is greatly improved. Sticking oneself in with an injection needle is not an easy experience for many people. This is not a simple task. Moreover, the permanent implantation of the injection needle ensures that the injection is always delivered to the most The injection is performed at a suitable location selected to be effective. The drug is injected into the patient's body through an injection needle. There are many possible technical variants for injecting the Compared to alternative forms of manually injecting drugs from outside the body, once the injection needle is implanted, This is obviously more convenient for the patient.

[0009] Thus, according to the invention, a system for injecting a substance into a patient's body comprises one or more or a plurality of injection needles, the tip of the injection needle being preferably biaxially spaced apart at at least one piercing region. The housing may be configured to penetrate one or more outer walls of the housing at one or more different penetration areas (at least As will be described later, two or more different penetration areas may be disposed within the housing. Two or more injection devices in a single housing or in different housings for injecting drugs into Needles may be provided or may be inserted to penetrate the outer wall of the housing at different penetration areas. A single needle is provided in a single housing together with a suitable drive unit for moving the tip of the needle. An injection needle may be provided.

[0010] Moreover, according to the invention, at least one actuator adapted for implantation in the patient's body is provided. The unit is provided with at least one injection port for penetrating the exterior wall of at least one penetration area. a needle tip coupled to at least one injection needle for advancing and retracting the needle tip; A substance can be injected through the at least one piercing area via an injection needle. At least one injection needle is inserted into at least one housing at two or more different penetration areas. When the needle is positioned to penetrate the outer wall of the casing, at least one needle may be inserted simultaneously (e.g., multiple times). several hands, i.e. where at least two hands are provided) or immediately following each other (e.g. For example, if a single needle is provided, it penetrates at least two different penetration areas. A single command or operation from the patient triggers the corresponding mechanical structure of the drive unit. or by a suitably configured control unit which controls the drive unit. It is sufficient to inject the substance through at least two penetration areas. This allows the system becomes easier for patients to handle.

[0011] In addition, according to the present invention, the drive unit further comprises at least one of the injection needles. For at least one, and preferably all, of the injection needles, the injection needle tip is ) in at least two different directions. In other words, the injection needle is capable of transverse movement in at least two dimensions. As will become apparent from the detailed description of the preferred embodiment, such a configuration This allows the overall size of the stem to be reduced.

[0012] The injection needle is adapted to move in a transverse direction as described above with respect to the at least two different directions. Thus, different penetration sites within said at least one penetration region, preferably within each penetration region, and configuring the drive unit to reach specific penetrations of the exterior wall of the housing along the two-dimensional array. 2. Varying the penetration site within the perfusion region, thereby varying the penetration site within a particular infusion region within the patient's body. It is particularly preferred to vary the injection position accordingly. After the cycle, the injection needle returns transversely to its initial position, allowing the next injections to be made in the same penetration area. However, the first number of penetration sites may be slightly offset above or below the transverse direction of the first number of penetration sites. By doing so, a two-dimensional array of penetration sites can be obtained in each penetration region. A three-dimensional array of penetration sites through the outer wall of the housing by a drive unit appropriately adapted to Although it is possible to obtain a spherical shape for the housing or at least the window area thereof, This allows for a great deal of flexibility in the use of the system. Repeated pricking of the same body part causes inflammation, which eventually leads to further pricking. It may become difficult or even impossible to administer one or more needles during each injection cycle. Varying the injection site by moving the catheter transversely overcomes these problems. Different penetration regions can be used to obtain a two-dimensional or three-dimensional array of penetration sites in each penetration region. The penetration is performed by moving one or more needle tips in different directions between penetration sites. The maximum dimension of the region can be kept to a minimum.

[0013] As previously mentioned, at least one injection needle is preferably provided with two or more different penetration regions. The housing is disposed to extend through at least one outer wall of the housing. As will be appreciated, this allows the tip of a single injection needle to be inserted into two or more penetration regions within a single housing. or for each of two or more penetration areas. This can be achieved by using separate injection needles provided at the piercing area, which is connected to a common housing. The power supply may be provided within the same housing as the power source, or may be provided within a different housing.

[0014] That is, a single injection needle is provided within a housing, which is inserted into the patient's body. When implanted adjacent to two or more injection areas within a catheter, the drive unit may be configured to drive two injection needles ( Various traverses are possible to penetrate the outer wall of the housing at different penetration areas (100 mm or more). The infusion needle may be configured to move the tip of one infusion needle laterally between the orientation positions. As a result, the injection needle is forced to make a transverse movement between two (or more) penetration areas. and between multiple penetration sites within each of the two (or more) penetration regions. The device is positioned to provide transverse movement in one or three dimensions, thereby allowing the patient to achieve penile erection. When arousal is desired, the needles are inserted so that the drug can be injected, for example, into the left and right corpora cavernosa. The drive unit is then driven through the outer wall of the housing in two different penetration areas. The tip of one injection needle is traversed to different penetration sites within each of the different penetration regions. It can be moved in any direction so that if the patient wishes to achieve another penile erection later, The injection needles are not inserted into the same penetration site, but into different penetration sites within a particular penetration region of the outer wall of the housing. Penetrates the passage site.

[0015] However, the system advantageously allows a single needle to penetrate two (or more) different areas of penetration. and for transverse movement in a first direction between at least one of the different penetration regions. and preferably within each of them, only one second direction different from the first direction. It should be noted that it may also be used in a configuration arranged for transverse movement. This configuration does not provide a multi-dimensional array of penetration sites in each penetration region, but Nevertheless, the overall system size can be substantially reduced. Preferably, the direction of transverse movement within each of the different penetration regions is different from that between the different penetration regions. This differs from, and in particular is perpendicular to, the direction of transverse movement of the Depending on the requirements, it can be suitably configured to operate with a single multi-function drive unit or in a coordinated manner. This can be achieved by using a number of different drive units made up of different actuators.

[0016] The distance between two different penetration areas to be penetrated by at least one injection needle is Select each site on the patient's body to be pierced whenever the drug can be injected. When two (or more) penetration areas are subject to action by a single injection needle , the distance of transverse movement of a single injection needle between different penetration regions during each successive injection is Such continuous injections reach distances of 3mm, 4mm, 5mm, or more. Preferably in immediate succession, the time between the penetration of the first region of the penetration area and the penetration of the second region of the penetration area is The delay is preferably as short as possible, more preferably less than 120 seconds, and most preferably less than 60 seconds. Therefore, when the injection needle retracts from the first of the two penetration regions, It is preferred that the second region of the penetration area is immediately advanced to the second region of the penetration area.

[0017] Transverse axial members contained within the housing penetrate the outer wall of the housing at different penetration locations. An implantable injection device having a single injection needle movable in WO2007 / 051 563. However, this prior art device has two or more different intended to deliver simultaneous or near-simultaneous immediate succession of drugs to multiple infusion areas. Instead, the device is not, and is not configured to be, The actuation unit is configured to administer the drug at different penetration sites of a single injection area each time it is actuated. For example, prior art devices may be configured to separate different injection sites within a single injection region of a blood vessel. The catheter may be placed along a blood vessel to inject a drug into the blood vessel. The device measures the distance of transverse movement of the tip of the injection needle between one injection and the next. The device is not designed to reach different injection areas within the patient's body. Prior art devices are designed to move the injection needle in different directions transversely of the injection needle. In particular, prior art injection devices have not been designed to separate injection sites within different injection regions. It is not designed to change the site transversely and is not designed to penetrate the two- or three-dimensional array. In addition, prior art injection devices are not designed to achieve a penetrating site. It is not intended to be used for stimulation to cause erection of the penis.

[0018] Similarly, instead of having a single injection needle in a single housing, as briefly mentioned above, Instead, it has two or more injection needles in a common housing or in separate housings, and the penetration area It is possible to provide a system with one needle per area. A needle can be provided for each penetration area. Two different areas can be used to induce penile erection. If it is desired that injections be made only in the periphery of the ventricle, then two separate injection needles are preferably At the same time, they advance through the corresponding penetration areas of the respective housings and retract again after injection. Within each penetration region, each injection needle may have at least one of the following configurations: The drive unit is preferably adapted to move the actuator transversely in two different directions. The tip of two or more injection needles is moved transversely at the same time. For example, a drive unit, perhaps a sliding turntable and / or shuttle. This can be achieved by attaching the injection needle to a movable carriage of the For example, the injection needle may be disposed above within a common housing.

[0019] for respectively advancing and retracting one or more tips of one or more infusion needles The drive unit preferably drives the tip of the infusion needle every time the tip of the infusion needle advances or retreats. Therefore, the transverse movement of the tip of the injection needle and The transverse movement of the tip of the injection needle is performed before and / or after the injection. This mechanism may be implemented after a certain number of transverse movements or over a certain distance. After a certain transverse movement, the tip of the injection needle is moved transversely back near its initial position for a next number of times. The injection may be such that the injection occurs close to the site of the previous needle penetration.

[0020] Regardless of the number of needles involved and regardless of the particular sequence of penetration sites to be achieved, Transverse movement of the tip of one or more injection needles results in advancement of the tip of one or more needles and and / or it is preferable to configure the drive unit so that this is achieved automatically during reversing. For example, the injection needle may be supported on, for example, a sliding turntable or a When mounted on a movable carriage, such as a syringe or shuttle, the drive unit drives the syringe so that the injection needle Automatically advance the movable carriage a predetermined distance each time it moves forward and / or backward. The apparatus may include a stepper adapted for performing the steps.

[0021] According to one aspect of the invention, the outer wall can be actively opened to allow an injection needle to penetrate the wall. However, according to another aspect of the present invention, the outer wall can be penetrated by piercing the outer wall. It is preferable to position the needle so that the outer wall is pressed against the injection needle when the injection needle is advanced. The device may have a flap that can be pushed aside, at least in the penetration area, The entire housing may be made from a material that is self-sealing against penetration by an injection needle. The self-sealing material may be formed in the exterior wall of at least one window. The window region is advantageously stable when forming the region, and the window region is formed by at least one implantation. The window area is pressed into the outer wall and positioned to be penetrated by the tip of the needle. The outer wall may be formed by a self-sealing piercing membrane, preferably integrated therein. The self-sealing material is preferably made of a polymeric material consisting of silicone. Other biocompatible polymeric materials such as rethan may also be used.

[0022] The self-sealing material may be a composite material. Particularly preferred embodiments of such composite materials The device comprises at least one outer shape-imparting layer and a self-sealing soft material contained within the outer layer. The outer layer thus forms an outer shell for the soft material. The endothelial cell may be made of a biocompatible polymer, such as one of the following: The material may be a gel.

[0023] Instead of a self-sealing material, the portion of the outer wall to be penetrated by the injection needle may be one or more The device may have one or more flaps at the penetration area through which multiple injection needles can pass. This reduces the force required for the injection needle to penetrate the outer wall compared to penetrating a self-sealing membrane. The flap is preferably pushed by the infusion needle as the infusion needle advances. It is positioned so that it can be removed.

[0024] Alternatively, the exterior wall may be provided with at least one door in the penetration area. A drive mechanism for the injection needle is connected to the door so that the injection needle can be advanced through the open door. A normally closed flap, such as an elastic flap, may be provided. This is connected to the door. It is particularly preferred if the drive device forms part of a drive unit which is coupled to the injection needle. More specifically, the arrangement is such that the drive unit advances the infusion needle while the drive mechanism drives the door. It may be something like opening.

[0025] According to a preferred application of the system of the present invention, the housing or housings are In vivo, adjacent to the two corpora cavernosa and / or their two deep arteries, and / or or adjacent to the muscle tissue that regulates blood flow through the patient's left and right corpora cavernosa; and / or The implants are adapted for implantation adjacent to the tissue adjacent to the two corpora cavernosa. Where a single housing for the needle is provided or where two or more penetration areas are provided in a single housing When placed within the casing, the penetration area is located within the left and right corpora cavernosa and / or right and left corpora cavernosa of the patient's penis. The arteries are adjacent to the two deep arteries of the right and left corpus cavernosum and / or pass through the right and left corpus cavernosum. adjacent to muscle tissue that regulates blood flow, and / or when certain drugs are injected into the first The corpus cavernosum and the second corpus cavernosum are placed close enough to another type of tissue to allow for swelling. The sensor may be disposed within the housing so that the sensor can be mounted on the sensor.

[0026] At least one injection needle preferably has a tubular body closed at a tip and adapted to be inserted into a particular body part. The device has a delivery outlet port disposed on the side for delivering the drug to the Thus, the needle does not cut through any material during penetration, it simply divides the material. Therefore, when the needle penetrates materials such as fibrotic and / or self-sealing piercing membranes, drug delivery may be compromised. There is no material entering or blocking the burr passage.

[0027] The system further comprises at least one reservoir adapted for implantation within the patient's body. The reservoir may be adapted to supply an injection needle with a substance to be injected into the patient's body. and adapted for implantation within a patient's body. at least one pump adapted to advance the substance from the reservoir to the at least one injection needle; It may also be provided to allow

[0028] Due to space constraints, it is preferable to implant the reservoir away from the injection area. In some cases, it may be advantageous to use a long injection needle that can be flexibly bent. The tip of the injection needle is disposed within the first housing so as to penetrate the outer wall thereof upon advancement of the long injection needle. while the other end of the injection needle is inserted into a second housing that is remotely implanted within the patient's body. The injection needle is inserted from the second housing for remote implantation into the first housing, and The distance through the first housing to the outer wall of the first housing to be penetrated by the needle Long enough to bridge the gap. A long, flexible injection needle with a suitable sheath is required. Moreover, due to space constraints, it may be preferable to introduce the Preferably, the second housing has a reservoir embedded therein, and even more preferably, remotely. of a drive unit for advancing and retracting the tip of an injection needle in a common housing for It is also advantageous to place at least a part of the device in the vicinity of the motor, pump, etc. Most or all of the moving parts are contained within a remotely embedded second housing. However, the first housing only contains passive elements.

[0029] The drive unit according to the present invention includes not only the drive device itself, such as an electric motor, but also a transmission device, etc. The drive energy provided by the drive unit is converted into the movement of at least one hand. This also includes components related to the above.

[0030] For example, in the case of a long, flexibly bendable injection needle, the drive unit may rotate the injection needle. or by rotating an element cooperating with the injection needle, the injection needle is advanced and More specifically, the injection needle may be advanced and / or retracted. The drive unit for driving the actuator may comprise a screw drive connection. The drive of the unit rotates a screw that is threadedly attached to a rack that is connected to the injection needle. The injection needle may be advanced or retracted by rotating the screw. The screw and rack of the drive connection are preferably connected to a remotely embedded second The needle may be housed in a housing, or may be disposed in a housing that houses the tip of the needle. Instead of a needle, the injection needle itself is rotated by a suitable drive device, and as the injection needle rotates, The injection needle is secured to the rack by engaging the needle threading with a fixedly mounted rack. The housing may be configured to move forward or backward. The injection needle is preferably fitted with a catheter to reduce friction and to prevent fibrotic proliferation that may impede needle movement. The catheter is guided within the sheath to prevent

[0031] The injection needle, or in the case of the long, flexibly bendable injection needle described above, at least its tip, The drive units may also preferably be included in a common housing in a spaced apart relationship. At the same time, the at least two different penetration regions are provided to penetrate the outer wall of a common housing. The needle is disposed within a common housing. or at least positioning its tip so that it is close to the injection area Moreover, a single drive unit can advance the tips of multiple injection needles. and backing away from the system, thereby reducing the overall system volume. The use of a single drive unit means that the drive unit is also contained in a common housing. In particular, when the driving unit is also implanted close to a very limited injection area. is advantageous.

[0032] Turning now to reservoirs, many currently available drugs cannot be stored for long periods of time. Please take into consideration that this is especially true for drugs that stimulate penile erection. When used in a catheter, the drug to be infused is typically provided as the first substance and the infusion is performed. The second substance is mixed with the second substance for injection immediately before injection. According to an embodiment, the reservoir of the system may include a small amount of fluid for containing an infusion solution, such as saline. At least one first compartment and, for example, a drug for mixing with the infusion liquid of the first compartment, in particular a dry and at least one second compartment containing a drug in dry form. The drug is in powder form. More specifically, the drug may be a lyophilized drug. The drug is a drug for stimulating penile erection. a mixing chamber for mixing with the material from one or more of the second compartments of the Good too.

[0033] The number of second compartments may be large, such as 50 or more, particularly 100 or more. The amount of drug required for each stimulation to produce an erection is very small, just a few micrograms. Therefore, space constraints are not a particular issue. Do not insert the needle into the patient's area away from the housing, such as near the symphyseal bone. The device may be adapted for implantation in the patient's body. There is a lot of space available above the patient's pubic bone, The agent can be delivered to the tip of the needle through a suitable conduit. After the infusion is completed, use pure saline to clear the tubing and needle of any residual drug. A saline solution can be injected. Such injection cleaning is useful for cleaning different areas of the outer wall of the housing. The penetration area allows access to the patient's tissues that do not affect penile stimulation.

[0034] Preferably, the second compartment containing the medicament is provided with a fluid tight seal with the first compartment; A mechanism is provided for individually opening the connections between the second compartment and the first compartment.

[0035] According to a preferred embodiment, the second compartment is open towards the first side of the plate. and an opening mechanism for opening the second compartment to the first side of the plate. to act on the second section from a second side of the plate opposite the first side of the plate. Thus, the second compartment is adapted to, for example, display the contents of the opened second compartment. It opens forward into a mixing chamber where it mixes with the contents of the first compartment of the reservoir, such as saline. , may be pushed from the rear side (the second side of the plate). More specifically, the second section may be attached to the plate as a movable drug container, and the opening mechanism may be as described The drug container is adapted to move the drug container to deliver the drug contents as described above. This is also fine.

[0036] Alternatively, the plate may be adapted to align the drug container with the conduit as the plate rotates. Thus, when aligning a drug with such a conduit, The drug may be mixed with saline, for example, which is pumped through a conduit into an infusion needle. .

[0037] According to another preferred embodiment, the second section is attached to a tape wound on a reel. The second sections of the multiple rows are arranged in parallel in a direction different from the direction in which the tape is wound. In this way the length of the tape can be reduced. It is particularly preferred if the tape is contained in a replaceable cassette. When the second compartment of the tape is completely emptied, the tape can be stored by replacing the cassette. can be easily replaced.

[0038] As previously mentioned, the reservoir is generally a portion of the housing that contains at least one injection needle. Alternatively, the reservoir may be separated from the housing for remote implantation within the patient's body. It is preferable to place

[0039] At least a portion of the periphery of the first compartment of the reservoir is in contact with the infusion liquid when the reservoir is filled with the infusion liquid. Alternatively, the volume of the first compartment can change due to deformation of the flexible material when withdrawn from the reservoir. The reservoir may be of the balloon type. The flexible material may comprise a polymer film. A bellows structure with curved creases is preferred.

[0040] According to certain embodiments, drawing liquid from the reservoir causes at least a portion of the reservoir to The pressure is reduced at the reservoir and is therefore negative compared to the pressure in front of the injection needle. The first compartment of the bath may comprise a gas chamber and a liquid chamber, the chambers being provided with a membrane, When liquid is drawn out of the liquid chamber, it is separated by a polymer membrane, for example. The pressure in the gas chamber decreases accordingly.

[0041] The reservoir has an injection port for injecting liquid into the implanted reservoir from outside the human body. In this way, the reservoir implanted in the patient's body together with the injection device may be The suction cups are relatively small and can be easily refilled at appropriate intervals, possibly with the assistance of a physician. It may remain as it is.

[0042] Preferably, the injection port is an inlet port for filling the reservoir, typically through the patient's skin. It is made of a material that is self-sealing against penetration by the refill syringe used. The sealed injection port is easily accessible to the patient for filling with a syringe. It is preferably implanted subcutaneously in the body.

[0043] One or more devices for connecting a remotely implanted reservoir to one or more injection needles. The ductus is long enough to span the distance between the patient's pubic bone and the patient's inferior urogenital diaphragm fascia. The conduit should have a housing, preferably located at the pubic bone. It should have a length of at least m.

[0044] It has been shown that drugs, especially those used to stimulate penile erections, can decompose during long-term storage. Another important influence on drug degradation is storage temperature, as pointed out in The drug must be stored in a refrigerator at low or at least moderate temperatures. Thus, a preferred embodiment of the present invention comprises maintaining the contents of at least one compartment of the reservoir at 37° C. This provides a cooling device that maintains the temperature of the drug to be cooled below 100° C. When the amount of drug in the reservoir is very small, and the drug compartment in the reservoir is thermally insulated, This can be achieved with a relatively small energy supply when The server may be contained within an insulated chamber.

[0045] A cooling device having a heat exchanger for exchanging with the patient's body heat generated by the cooling device. It is preferable to provide a heat exchanger that is suitable for use in a water storage tank. Such a heat exchanger is not likely to adversely affect the contents of the reservoir. away from the cooling device to safely dissipate heat energy in areas where it cannot be The device may be implanted in the patient's body.

[0046] The cooling device may be of various different types. According to a first embodiment, the cooling The device may contain at least two different chemicals that react with each other, thereby The heat energy drawn from the contents of the reservoir is then consumed, resulting in a loss of heat to the contents. A cooling effect is achieved. The two chemicals may be provided in separate chambers and A constant amount of two is added to control the amount of heat energy drawn from the contents of the reservoir. A flow control device may be provided for combining the different chemicals.

[0047] According to a second embodiment, the cooling device may comprise at least one Peltier element. A Peltier element is a device that generates a temperature difference when an electric current passes through it, based on the Peltier effect. When one part of the Peltier element cools, a different part heats up. Such heat can be dissipated by a heat exchanger or by direct dissipation of heat to adjacent body parts of the patient. Just expand the surface of the specific part that generates the heat, and it can be removed again. .

[0048] According to a third embodiment, the cooling device may be of refrigerator type construction, i.e. The heat exchange pipes in the chamber to be cooled and the thermal energy absorbed in the cooling chamber The heat exchange pipes outside the chamber for dissipating the refrigerant gas are a compressor to compress the refrigerant gas when it is cooled, and a compressor to expand the refrigerant gas before it re-enters the cooling chamber. It is provided together with an expansion valve.

[0049] We now turn our attention to pumps that advance infusion fluid from a reservoir to one or more infusion needles. To this end, such pumps may be manually operated or automatically operated. The manually operated pump may be appropriately positioned under the patient's skin. The balloon type pump may be formed from a balloon that can be manually compressed when the pump is inserted. The pump may simultaneously serve as a reservoir for the infusion fluid, in particular for saline. However, preferably an automatically driven pump is used. The type of pump is not critical. However, certain types of pumps are particularly preferred. More specifically, implantable pumps. The valve preferably comprises a valve device having a first valve member and a second valve member, the first valve member and the second valve member are adapted to form a sealing contact between the first valve member and the second valve member, respectively. and having two smooth surfaces facing each other while maintaining sealing contact. It further has different liquid channels which can be aligned by moving the fine surface. This type of pump is described in more detail in WO2004 / 012806A1. The first valve member and the second valve member preferably have excellent long term sealing properties and are highly flexible. It is made from a ceramic material to provide inertness to bacteria.

[0050] The pump may also be a membrane-type pump as described in WO2004 / 012806A1. The pump may be, but is not limited to, a diaphragm-type pump. The piston may include a membrane movable by the piston as the piston moves, and a piston adapted to move the first valve member and the second valve member slidably relative to one another when the piston moves. Preferably, the pump is adapted for remote implantation within the patient's body. The needle is embedded in a housing that is separate from the housing containing the needle or needles.

[0051] Due to space constraints in the area of ​​the patient where the injection is to occur, one or more injections may be required. Embedding as many components of the system as possible away from the housing that contains the needle In such a situation, the drive unit can be operated at a minimum from a remote location within the patient's body. Both may comprise a mechanical drive element for transmitting kinetic energy to the injection needle. The mechanical drive element is a rotating shaft that can span significant distances within the patient's body. The rotating shaft may be configured to rotate the injection needle in a straight line when rotated about its axis of rotation. More specifically, the rotating shaft may be rotated. and / or each time one or more injection needles are advanced and retracted. In the form of a worm screw that moves one or more injection needles transversely A separate rotating shaft or worm screw may be used for each injection needle. and / or by advancing and retracting the tip of one or more injection needles on the one hand and one Alternatively, a plurality of injection needle tips may be provided for moving in a transverse direction. In most cases, the rotating shaft or worm screw is flexible and therefore can bend freely. The device can be freely positioned within the patient's body.

[0052] Alternatively, or in addition, the drive unit may be arranged to move the infusion needle upon actuation of the wire. The injection needle may further comprise at least one wire which cooperates directly or indirectly with the injection needle. Thus, the wire is pulled at its end located away from the injection site within the patient's body. Preferably, the wire is connected to the same conduit that connects the injection needle or needles to the reservoir. More specifically, by pulling the wire, one or more injection The tip of the needle is inserted from a first region of a different penetration region to a second region of a different penetration region, or It may move transversely from a first penetration site to a second penetration site of a single one of the regions. A single messenger wire (pulling wire) moves the infusion needle in one direction. It may be sufficient to bias the injection needle to the initial starting position or to a different starting position. A spring element or any other pretensioning means for returning it to position may be provided. Alternatively, two messenger wires can be used to move the infusion needle back and forth in a single dimension. It may be provided.

[0053] According to a preferred embodiment, the injection needle is arranged for two-dimensional transverse movement. This can be accomplished by two messenger wires, preferably A spring element or other pretensioning method is used to provide a reaction force by pulling on the Alternatively, the injection needle may be moved along at least two directions in a two-dimensional plane. Three messenger wires may be provided to move the tip back and forth laterally. stomach.

[0054] The messenger wire also advances or retracts the infusion needle by pulling on the wire. Also, the injection needle may be biased to its initial starting position or to a different position. A spring element or other pretensioning means may be provided to return to the starting position.

[0055] Alternatively, the drive unit may be adapted to advance the tip of the infusion needle and / or to drive the infusion needle. At least one injection is performed from a remote location within the patient's body to move the tip of the catheter transversely. A hydraulic drive may be provided for transmitting hydraulic energy to the entry needle. It may be used as a hydraulic medium to supply pressure energy, or a secondary liquid different from the injected liquid may be used. may be used.

[0056] Further alternatively, the drive unit may be provided with a housing interior that accommodates at least one injection needle. The power supply may be provided with one or more electric motors. In this case, the energy is supplied to the appropriate wires. The ring may transmit the signal from a remote location within the patient's body to the at least one motor. Also, as with the two previously described alternatives, the tip of one or more injection needles may be advanced and retracted. and for moving the tip of one or more injection needles laterally. A single motor may be provided, one for each injection needle and / or one for each Advancing the tips of the multiple infusion needles while moving one or more of the infusion needles laterally For this purpose, individual motors may be provided.

[0057] Further alternatively, the drive unit may be adapted to move the tip of one or more infusion needles in a transverse direction. and / or for advancing and retracting the tip of one or more injection needles. For example, the electromagnetic drive may include a plurality of transversely spaced apart electromagnetic drives. A group of electromagnets consisting of a first portion of an electromagnet and at least one second portion of an electromagnet wherein the second portion of the electromagnet cooperates with the energized first portion of the electromagnet. The second portion of the electromagnet is fixedly attached directly or indirectly to the injection needle or needles. When one or more of the first portions of the electromagnets are connected together and thus energized, the electromagnet The second part of the stone and therefore the injection needle or needles move. The arrangement of the first and second parts of the electromagnet is such that the first part of the electromagnet is arranged on the first surface and the second part of the electromagnet is arranged on the second surface. may be such that the portion is movable forward or backward of the first surface. The first portions of the electromagnets face each other, thereby defining a first plane therebetween. The first part of the electromagnet may be movable in the first plane. Depending on which of the sections is energized, one or more injection needles are attached to the fixed electromagnetic The second part of the stone moves accordingly. The first part of the magnet is preferably Includes air coil.

[0058] In any of the foregoing alternatives, at least one injection needle is attached to a remotely implanted respirator. It is advantageous to transmit the drive energy through a conduit connecting to the reservoir: In the case of mechanical drive elements in the form of a wire or rotating shaft, the wire / shaft and The infusion fluid may be conducted through a common conduit. The common conduit separates the two separate paths. One for the shaft or wire and one for the infusion fluid. Such a common conduit allows for easier handling and placement of the system during implantation. The wiring for transmitting electrical energy to a motor or electromagnetic drive may consist of one or more Alternatively, the injection needle may be guided through a conduit connecting the injection needle to the reservoir.

[0059] If the pump and / or drive unit is not manually operated, a drive in the form of a motor The device may, for example, be configured to electrically, magnetically or electromagnetically couple the pump and / or the drive unit. or arranged to hydraulically operate the pump and / or drive unit. The motor is preferably arranged to operate the pump or the drive unit. and thereby simultaneously actuating the other, for example a drive unit or a pump. A motor may be provided to operate any other energy consuming parts of the infusion device. More specifically, multiple motors may be provided, for example an individual motor for each injection needle. and / or a transverse movement of the tip of the injection needle on the one hand and the housing on the other hand. A separate motor may be provided for advancing the tip of the infusion needle through the outer wall of the casing.

[0060] Also, the space required for the implantation of the housing that accommodates the injection needle or needles is reduced. The limitations of this approach mean that the motor cannot be implanted remotely within the patient's body, separate from the housing. It is also advantageous to provide an actuating means for manually actuating the motor or motors. Such actuation means may preferably be adapted for subcutaneous implantation.

[0061] The term "motor" according to the present invention refers to any device that uses energy other than manual force. Such energy can be kinetic energy or hydraulic energy or any other type of Automatically converting it into energy or using such energy directly to pump , drive unit, and / or anything that operates other parts of the overall system. Thus, for example, in the case of an electromagnetically actuated drive unit, part of the drive unit It is possible for the rotor to also form part of the motor.

[0062] For conductively or wirelessly transmitting energy from outside the patient's body to the motor. Coupling elements may be provided, for example the motor may be wirelessly driven by an external electromagnetic field. The sensor may be arranged so that the sensor is fixed to the sensor.

[0063] A pump, a drive unit, and a drive device (motor) for driving the drive unit; and at least one of any other energy consuming parts of the system. For example, a primary energy source attached to the patient's skin may be provided. An external energy source or battery, particularly a rechargeable battery, for use outside the patient's body The energy source may be the pump and / or the drive unit and / or any other part of the system. The energy source may be used to supply energy to an energy consuming part. In particular, it may be connected to at least one motor for actuating these components. The external energy source for wireless energy transfer can be an electromagnetic field, a magnetic field, or generates an external field, such as an electric field, or a wave signal, such as an electromagnetic or sound signal may be adapted to generate

[0064] If the energy is transmitted wirelessly to the implanted component, A conversion device may be provided for converting the delivered energy into electrical energy. Such a conversion device is preferably provided with an energy supply means external to the patient's body. Adapted to be placed directly under the patient's skin to minimize the distance and amount of tissue between will be done.

[0065] Alternatively, or in addition to an external energy source, the system may be powered by an implantable energy Such an implantable energy source may include one or more injection needles. The patient may be a part of or contained within a housing that contains the patient. an implantable energy source separate from the housing for remote implantation within the body of a Such an implantable energy source is preferably a long-life battery. An energy storage means, such as a pond, more preferably an accumulator is provided. The accumulator has the advantage that it is rechargeable. Preferably, the accumulator is a rechargeable battery and and / or a capacitor.

[0066] Also, the primary energy source outside the patient's body is conductively or wirelessly transferred to the accumulator. The coupling elements for transmitting energy are connected to the device when the device is implanted in the patient's body. Provision may be made for charging the accumulator from outside the patient's body. The motor is conductively and / or wirelessly connected to at least one motor of the injection device. A coupling element for supplying energy may be provided.

[0067] Advantageously, a feedback subsystem, which may be part of the control unit described below, a feedback system for receiving feedback information related to the energy stored in the energy storage means; can be wirelessly transmitted from inside the human body to its outside. Then, the feedback The information is used to regulate the amount of wireless energy transmitted by the energy transmitter. Such feedback information is used to measure the wireless signals received inside the body. The amount of energy consumed by at least one energy-consuming part The above-mentioned measurements may be related to energy balance, which is defined as the balance between the amount of energy consumed and the amount of food consumed. Alternatively, the feedback information may be the amount of wireless energy received inside the human body. Balance between the rate and the rate of energy consumed by at least one energy consuming component The above-mentioned parameters may be related to energy balance, which is defined as:

[0068] Preferably, at least one injection needle is provided for controlling the amount of injection fluid to be administered. A control unit is provided for the purpose of controlling the activation of the push button or other type of switch once. A single command from the patient to the control unit, such as It is sufficient to control the injection of the drug at two different locations. pumps, drive units and motors, and any other energy consuming parts of the system and wherein the system is provided for controlling at least one of an internal energy source or If an external energy source is included, it may be provided for controlling said energy source. The control unit is preferably one or more implantable devices that are implantable within the patient's body. The control unit is separate from the housing that contains the multiple injection needles. It may be timed to be administered at the appropriate time to a specific one of the injection sites. This will substantially reduce the burden on patients.

[0069] Preferably, the control unit is included in a housing that accommodates the injection needle or needles. The control unit may be attached to the patient's body or may be implanted in the patient's body separately from the housing. The system consists of an external data processing device outside the patient's body and a control unit implanted inside the patient's body. The data transfer port is used to transfer data between the This allows the control unit to be monitored to adapt the system to changing patient requirements. Preferably, the data transfer port is adapted to allow communication between the control unit and an external data port, for example during a medical examination. Wireless communication for data transfer is provided to easily realize data exchange between data processing devices. Most preferably, the control unit is adapted to further increase its adaptability. Alternatively, or in addition to, an external data processing device. The control unit may then be provided with a manual operation by the patient to initiate operation of the control unit. External components may also be included.

[0070] Separately from or as part of the control unit, feedback on treatment-related parameters Such parameters may include the patient's physical parameters and and / or processing parameters of the system. At least one feedback sensor is provided to provide a feedback signal. Back sensors measure drug levels, intravascular flow, pressure, electrical parameters, expansion, distance, etc. The system may be adapted to sense one or more parameters relating to any of the following:

[0071] The feedback sensor may be connected to a control unit, the control unit being configured to for controlling drug delivery in response to one or more signals from a back sensor Additionally or alternatively, the feedback data may include Such feedback may be transmitted from the control unit to an external data processing device. The data can be useful to doctors in making diagnoses.

[0072] One or more of the housings in which the one or more injection needles are disposed The penetration areas of the wall may be located at various locations within the patient's body. For example, the penetration areas may be located at the left and right the corpus cavernosum of the penis and / or the two deep arteries passing through the left and right corpora cavernosum of the penis and / or the patient's The muscle tissue that regulates blood flow through the left and right corpora cavernosa and / or the tissue adjacent to the left and right corpora cavernosa It may be placed adjacent to another type of tissue.

[0073] Fixing one or more housings to the corpus cavernosum so that the housings remain in place A holder may be used to mount the device.

[0074] The other components of the system are preferably implanted remotely, such as adjacent to the patient's pubic bone. As previously mentioned, some components of the system may be implanted subcutaneously. The implant allows wireless energy transfer between the implanted and external parts of the system. and / or data transfer feasibility is increased. Also, the injection port of the reservoir is implanted subcutaneously. Once seated, the reservoir is filled through an injection port by a refill needle that penetrates the patient's skin. In particular, the reservoir compartment containing the saline solution is filled frequently. Other compartments containing individual small doses of drug need not be filled, although they may be required. In some circumstances, any implantable components of the system may be placed in the abdomen, or in the thorax. It should be understood that the motor may be mounted in a portion of the rotor, such as a rotor holder, or a rotor holder. For example, one or more of the motors described above may be mounted in the rotor holder. To start the operation of the control unit of the system, or simply to start the operation of the control unit of the system, An actuation means for direct manual operation by a user is also provided to be implanted subcutaneously. Such actuation means may be subcutaneously operable by the patient from outside the patient's body. It may take the form of an implantable switch.

[0075] The various above-mentioned features of the invention may not be combined in any manner, unless they are clearly contradictory. Preferred embodiments of the invention will now be described in more detail with reference to the accompanying drawings, in which: In addition, various modifications may be made without obviously impairing the overall functionality of the device. The individual features of the above embodiments may be used in combination or interchangeably. Although the description of the preferred embodiment is specifically directed to stimulation of penile erection, other uses are also possible. It should be understood that the present invention also encompasses such methods. [Brief description of the drawings]

[0076] [Figure 1] FIG. 1 illustrates the muscles of the perineum. [Diagram 2] FIG. 1 is a cross-sectional view of the penis. [Diagram 3] FIG. 1 is a top view of a first embodiment of the present invention including a single needle. [Figure 4] FIG. 13 is a top view of a second embodiment of the invention including a single needle and motor housed in a common housing. [Diagram 5] FIG. 13 is a top view of a third embodiment of the present invention including two needles in a common housing. [Figure 6] FIG. 6 is a plan view of a portion of the injection device of FIGS. 4 and 5. [Figure 7] FIG. 1 is a cross-sectional view of a perforation membrane made from a composite material. [Figure 8] FIG. 13 is a cross-sectional view of an exterior wall having a flap at a penetration area. [Figure 9] FIG. 2 is a cross-sectional view of an exterior wall having an actively openable door in the penetration area. [Figure 10] FIG. 13 is a cross-sectional view of an exterior wall having an actively openable door according to another embodiment. [Figure 11] FIG. 13 is a side view of a fourth embodiment of the present invention including a single needle that is both laterally and vertically movable. [Figure 12] FIG. 13 is a side view of a fifth embodiment of the present invention, similar to the fourth embodiment, but with an additional step for moving the needle laterally. [Figure 13] FIG. 6 shows a sixth embodiment of the invention in the form of a sphere for obtaining a three-dimensional array of penetration sites. [Figure 14] FIG. 13 is a side view of a seventh embodiment of the present invention including two laterally and vertically movable needles in a common housing. [Figure 15] FIG. 13 shows an eighth embodiment that uses the principle of advancing and retracting the infusion needle by a pull wire. [Figure 16] FIG. 13 shows a ninth embodiment using the principle of transverse movement of the infusion needle by a pull wire. [Figure 17] FIG. 10 shows a tenth embodiment that uses the principle of advancing and retracting the needle with a rotating shaft, resulting in transverse movement of the needle. [Figure 18] FIG. 1 shows a complete system of the invention according to a first variant, implanted in a patient's body. [Figure 19] FIG. 2 shows a complete system of the invention according to a second variant, implanted in a patient's body. [Figure 20] FIG. 1 shows a complete system of the invention according to a third variant, implanted in a patient's body. [Figure 21] FIG. 1 shows a drug compartment as part of the reservoir of a first principles system. [Figure 22] FIG. 13 shows drug compartments attached to a tape wound on a reel in a replaceable cassette as part of the reservoir of a second principles system. [Figure 23] FIG. 29 shows a portion of the tape of FIG. 28 in more detail. [Figure 24] FIG. 23 illustrates the principle of operation of the replaceable cassette of FIG. 22. [Diagram 25] FIG. 13 shows a drug compartment as part of the reservoir of a third principle system. [Figure 26] FIG. 26 is a cross-sectional view of the drug compartment of FIG. 25, including the insulating chamber and cooling device. [Figure 27] FIG. 27 illustrates the principle of the cooling device of FIG. 26 in combination with a heat exchanger. [Figure 28] FIG. 27 illustrates a specific embodiment of the cooling device of FIG. 26. [Figure 29] FIG. 1 shows a portion of a system with separate needles for the left and right corpora cavernosa implanted within a patient's body. [Diagram 30] FIG. 30 is a schematic diagram of the system of FIG. 29. [Diagram 31] FIG. 31 shows a portion of the system of FIG. 30, including a tube through which a needle can be advanced. [Figure 32A] 1A-1C show first and second embodiments for electromagnetically moving an infusion needle in multiple transverse directions. [Figure 32B] 1A-1C show first and second embodiments for electromagnetically moving an infusion needle in multiple transverse directions. [Figure 32C] 1A-1C show first and second embodiments for electromagnetically moving an infusion needle in multiple transverse directions. [Figure 33A] FIG. 13 shows a third embodiment for electromagnetically moving an infusion needle in multiple transverse directions. [Figure 33B] FIG. 13 shows a third embodiment for electromagnetically moving an infusion needle in multiple transverse directions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0077] FIG. 1 shows the muscles of the male perineum. Reference numbers 1, 2, and 3 denote the ischiocavernosus, The bulbocavernosus muscle is the outer urethral bulb that inserts into the perineal membrane. The urethra is surrounded on its sides by the most proximal part of the penis body, and on its back and sides by the corpus cavernosum 4, which surrounds the urethra 5. It surrounds the corpora cavernosa 6, 7. The ischiocavernosus muscle 1 surrounds the crus of the penis and lines the underside and medial surface of the crus. The bulbocavernosus muscle compresses the outflow through the deep veins of the perineum. Aids in erection by forcing blood from the bulbs to the shaft of the penis However, the ischiocavernosus muscle 1 compresses the outflow vein, forcing blood from the base of the penis to the shaft. Thus, the penis is maintained in an erect state. FIG. 2 is a cross-sectional view of the penis. As shown in the figure, The stalk is made up of erectile secretions, the paired corpora cavernosa 6, 7 on the dorsal side and the single corpus cavernosum ventrally. It is composed of three cylinders of spongy tissue. The deep arteries 9 and 10 run distally near the center of the corpus cavernosum. The deep penile arteries run through the corpus cavernosum and supply blood to the erectile tissue of these structures. The deep penile arteries are the main blood vessels of the cavernous sinuses of the penis and are therefore involved in penile erection. When the penis is relaxed, these arteries spiral out , restricting blood flow.

[0078] For simplicity, only the corpora cavernosa 6, 7 are shown in the following figures. A top view of a portion of the system according to the embodiment is shown. More specifically, a single injection needle 11 is connected to the housing. The needle 11 is disposed within a housing 12 such that the tip 13 of the needle 11 is in contact with the self-sealing wall 15 of the housing 12. In order to pierce the corpus cavernosum 6 or 7 located adjacent to the window area 14, The suction pipe 14 is positioned so that it can advance and retract in a longitudinal direction 16 through the suction pipe region 14. do.

[0079] Two window areas 14 are provided in the outer wall 15 of the housing 12, one window The area 14 is adjacent to each of the two corpora cavernosa 6, 7. The injection needle is connected to the drive unit D. The same drive unit can be used to move the window between the two window areas in the transverse direction 17. The injection needle 11 can be advanced and retracted by a drive unit D or a different drive unit. To this end, the injection needle 11 is mounted on a slide 18 for longitudinal advancement and retraction. The conduit 19 is connected to the infusion needle 11 for supplying the infusion fluid through the infusion needle 11 to its tip 13. It is connected to one end of 1.

[0080] In operation, the injection needle 11 first penetrates one of the two self-sealing piercing windows 14. The tip 13 is advanced to stimulate the penis to erect, and the injection fluid containing the drug for stimulation is The injection needle 11 is then injected into the corpus cavernosum 7, after which the injection needle 11 is retracted again. Upon retraction of the injection needle, the tip 13 of the injection needle is in contact with the other of the two self-sealing window areas 14. The injection needle 11 is then moved transversely along the direction 17 so as to reach the front of the injection hole 11. It then advances again so that it can be injected through its tip 13 into the other corpus cavernosum 7. Then the injection needle 11 is retracted again. At the end of this procedure, the injection needle 11 is in the position shown in FIG. This will be explained in more detail in conjunction with FIG. 11 and FIG. 12. The next injection cycle or cycles are performed at the same penetration site from the previous injection cycle. This is done via transversely offset penetration sites.

[0081] The structure of the system shown in FIG. 3 may be purely mechanical. As will be described in more detail below, the pressure that propels the injectate through the conduit 19 toward the needle 11 is typically In cooperation with the spring element, the needle 11 is advanced, retracted and transversely moved into the other window area 14. Thus, two injections of fluid may be directed through the conduit 19 toward the needle 11. After advancing, needle 11 automatically returns to or near its starting position shown in FIG.

[0082] However, a drive unit D is used within the housing 15 to achieve the desired movement of the needle. It is equally possible to incorporate one motor M or several motors M. This is shown in Figure 4. Of course, the motor M must be energized, and it is desirable It must be controlled in an appropriate manner to achieve the desired effect. This is illustrated in Figure 4. The energy is preferably delivered from a source either remotely implanted within the patient's body or delivered to the patient's body. The energy is transmitted to the motor M from an energy source located outside the body.

[0083] The driver D is adapted to drive the tip 13 of the injection needle 11 to the leading injection needle in the next injection cycle. Each penetration cycle is performed to penetrate the window region 14 at a different location compared to the previous cycle. The injection needle 11 is arranged to stop at a position different from the starting position after the injection (consisting of two injections). It can be done.

[0084] FIG. 5 shows a first embodiment, which is different from the first embodiment in that it comprises two injection needles 11 contained within a housing 15. 1 shows a top view of a third embodiment, which differs from the second embodiment. When the needles 11 are guided through the needle 19 toward the two injection needles 11, both needles move in the direction 16. They move forward and backward at the same time, so that the injection of the injection fluid occurs at exactly the same time. Unit D or another driving unit determines whether window area 14 is The injection needle 11 is attached so that it is penetrated by the tip of the injection needle 11 at different penetration sites. The turntable 20 may be rotated in a stepwise manner in the direction 17. 5, one or more motors M are components of the drive unit D. 14. Alternatively, the drive circuit 10 may be used to drive multiple As will be seen, after a number of injection cycles, the injection needle 11 is ready for the next number of injection cycles. is delivered through a penetration site that is transversely displaced from the penetration site of the previous injection cycle. The plate is then moved transversely upwards or downwards so as to

[0085] Next, the principle of the guide structure for moving the injection needle in the transverse direction will be described with reference to FIG. Such a guide structure is used, for example, for each of the two injection needles 11 shown in FIG. 3 and 4. It may also be used.

[0086] The guide structure 28 is rigidly secured adjacent the self-sealing window area 14. The window region 14 itself is implanted adjacent to the patient's corpus cavernosum 7. The guide structure 28 is The injection needle 11 (not shown) is rigidly connected to the injection needle 11 so as to cooperate with the guiding structure 28. When the injection needle 11 is advanced or retracted, the guide pin 27 , guided by a guide structure 28, thereby displacing the injection needle 11 in a transverse direction, The movement in the direction causes the turntable 20 (not shown in FIG. 6) to rotate. Resilient flaps 28a, 28b in the catheter 8 support the infusion needle 11 as it is repeatedly advanced and retracted. The guide structure 28 serves to guide the guide pin 27 through the entire guide structure 28. The guide structure 28 is self-supporting. To form different penetration sites through the self-sealing window region 14 to the corpus cavernosum 7. If necessary, the guide structure 28 may be designed with a guide pin 27 as shown in FIG. Such a return operation may include a return path 28c returning the housing 15 to its starting position. This is caused by a return spring 29 permanently fixed to a rigid part of the

[0087] The same structure allows a single injection needle 11 to be moved transversely between two window areas 14. 3 and 4. No, the structure corresponds to a larger distance to be overcome between the two window regions 14. must be slightly adapted so that

[0088] FIG. 7 illustrates a through hole used as a self-sealing window area 14 in an exterior wall 15 of a housing 12. A preferred embodiment of the permeable membrane is shown. The permeable membrane 30 is made of a composite material. The same material is It may also be used for other flexible walls or injection ports as described below in connection with other embodiments. The composite material of the penetration membrane 30 shown in FIG. 7 includes a self-sealing soft material 30b. The self-sealing soft material 30b constitutes the shape-giving layer 30a that defines the volume within which the shape-giving layer 30a is to be formed. The adhesive layer 30a has a viscosity such that it does not flow through the penetration caused by the injection needle 11 during penetration. Instead of a single outer shape-giving layer 30a, a shape-giving layer 30b may be formed. Layer 30a may comprise multiple layers. The shape-imparting layer 30a is preferably made of silicone and and / or polyurethane, since such materials are difficult to penetrate by the injection needle 11. The tubular member can be manufactured to be self-sealing with respect to passage.

[0089] As shown in FIG. 8, instead of a self-sealing membrane, a window area of ​​the outer wall 15 of the housing 12 is The area 14 may be formed by one or more flaps. Two flaps 30' made of a material are arranged to form a slit. The slit is normally closed and allows the injection needle 11 to pass through it as it advances. When the needle is advanced, it pushes aside the normally closed flap 30' and pushes the needle 11 back again. When retracted, the flap 30' is normally closed to form a seal against the ingress of bodily fluids. returns to the position where it was

[0090] Figure 9 shows a different embodiment, in which a self-sealing window 14 in an exterior wall 15 is functionally The door 30" can be opened by mechanical action. In the embodiment shown, the door is The window region 14 is made of a resilient biocompatible material that keeps the window region 14 closed in its normal position. The pull wire 300 is formed by the flap that is created. It is attached to one end of the door 30" to allow the door to be opened by pulling it. The infusion needle 11 is connected to a drive wire 300 or any other drive mechanism connected to the door 30”. For example, as shown in FIG. 10, a pull wire 30 0 is attached directly to the injection needle 11, and when the injection needle 11 is advanced, the door 30" is lifted at the same time. The injection needle 11 can pass under the door 30″ and therefore easily penetrate the outer wall 15. The door may be opened and closed by the pull wire 300 due to the elasticity of the material of the door. When the applied pulling force or other force is released, the door 30" closes automatically. In addition, the closing operation is performed by at least one spring element that biases the door to its closed position. Therefore, it may be supported.

[0091] FIG. 11 is a schematic diagram of a third embodiment based on the first and second embodiments shown in FIG. 3 and FIG. 4. 4. Thus, a single injection needle 11 has two penetration areas 14. Not only can the axial direction of ... The transverse movement is also possible between the portions 21. More specifically, the different penetration regions 14 The direction of transverse movement of the tip of the injection needle 11 within each of the different penetration areas 14 To achieve this result, the drive unit D advances and retracts the infusion needle 11 longitudinally along the direction 16 and the turntable 2 0 to pivot the infusion needle 11 along the pivot direction 17 between the two penetration areas 14, configured to raise and lower the injection needle 11 along a third direction 22 perpendicular to the direction 16 Any suitable purely mechanical structure may perform this function. However, if one or more of these functions One or more motors may also be provided to perform the first and / or second steps.

[0092] FIG. 12 shows a side view of a fifth embodiment similar to the fourth embodiment shown in FIG. In contrast to FIG. 11, the injection needle 11 is oriented perpendicular to the transverse movement direction between the two penetration areas 14. Transversely movable between different penetration sites 21 within the same penetration region 14 in an angular direction. Not only is there a difference in the direction of the cross-movement between the different penetration regions 14, but there is also a difference in the direction of the cross-movement between the different penetration regions 14. It is also movable laterally within the region 14. In other words, the tip of the injection needle 11 is The passage region 14 is movable transversely in two dimensions.

[0093] FIG. 13 shows a sixth embodiment in which an injection needle 11 can move along a spherically curved three-dimensional array of penetration sites. In this embodiment, a portion of the housing 12, more specifically, the window The region 14 is curved spherically, and the needle 11 rotates along the directions 17a and 17b. The inside of the sphere is arranged so that the tip 13 of the needle 11 can be moved to any position in front of the window area 14. Once the proper position for the tip 13 is adjusted, the needle 11 is The slide 18 can be advanced through the area 14. Instead of being housed in the sphere, the needle 11 may be attached to the outer surface of the sphere as well. 11 itself may be attached to the outer surface of the sphere. The sphere is moved along the directions 17a and 17b. The mechanism for applying the force can be of many different types, such as a mechanical structure using rollers or magnetic materials. It is possible.

[0094] FIG. 14 shows a seventh embodiment based on the third embodiment shown in FIG. The two needles 11 are moved longitudinally to advance and retract their tips through the penetration region 14. The injection needles 11 are provided in a common housing so as to be movable in each injection size. 5 to change the injection site 22 in the penetration region 14 with the , attached to the turntable 20. In addition, two injection needles are Similar to the fourth and fifth embodiments described above in relation to Again, the result is that the two different penetration areas 14 The direction in which the tips of the two injection needles 11 move transversely within each of the two different penetrations 12. As in the fifth embodiment, the tips of the two injection needles 11 are connected to each other in the same penetration area 14. It is movable transversely in the dimension.

[0095] FIG. 15 shows a principle of advancing and retracting the infusion needle 11 using a pull wire 101. The eighth embodiment shows a pull wire 101 located remotely from a location inside the patient's body. The tip of the injection needle 11 is inserted into the housing 12 by pulling the wire 101 at the end that is connected to the The coil spring is deflected about a pin 102 to advance through the window. When the pulling force of the pull wire 101 is released, the infusion needle 11 retracts. This principle can be combined with other embodiments described above and below. Instead of the coil spring 104, a second pull wire is provided to retract the infusion needle 11. The infusion needle 11 may be pulled in one direction or the other by pulling the wire 101 in one direction or the other. A single pull rod loops around two pins 102 to move the lever forward or backward. It is also possible to use a wire 101 .

[0096] The pull wire 101 and the conduit 19 for the infusion liquid are guided in a common sheath 103 . The common sheath 103 has various functions. First, the common sheath 103 is Second, the common sheath 103 supports the pull wire 101. 1. Third, the common sheath 103 is effective in preventing fibrosis. Protect the pull wire 101 from being pulled too hard.

[0097] FIG. 16 shows a remotely actuated catheter guided in a common sheath 103 together with a conduit 19 for the infusion fluid. 10 shows a ninth embodiment with pull wires 105, 106. and 106 respond to whether wire 105 or wire 106 is pulled. In this way, the injection needle 11 attached to the turntable 20 can be moved in one direction or the other. The two wires 105, 106 are attached directly to both sides of the injection needle 11 so that they can be moved in the axial direction. Instead of using 06, one of the wires may be a pre-insulated wire such as coil spring 104 in FIG. Tensioning means may be substituted. In addition, pulling on a suitable wire may be used. Thus, the injection needle 1 can be moved in a further direction so that a two-dimensional transverse movement can be achieved. A further wire, specifically a third wire (not shown), is provided for moving the wire 1 transversely. It may be provided.

[0098] Alternatively, if the infusion needle 11 is connected to an element other than the infusion needle 11, the pull wire may be such that one or more of the wires can be pulled. When the other elements are moved or rotated by tensioning, the injection needle 11 The tip of the is moved.

[0099] A flexible, long needle is disposed within the first housing. The first housing has an outer wall. and a distal end for penetrating the distal end of the second housing, the other end being disposed within a remotely embedded second housing. When the needle is placed in the injection needle, the turntable 20 is omitted and the needle is placed directly around the front end of the injection needle at regular intervals. By pulling the appropriate one of the three pull wires attached directly or indirectly to the Thus, precise transverse movement of the needle tip can be achieved.

[0100] FIG. 17 shows the advancement and retraction of the tip of the infusion needle on the one hand and the crossing of the tip of the infusion needle 11 on the other hand. A tenth embodiment is shown, which uses a different principle to move the actuator in the direction of the pull wire. In order to drive the rotating shafts 107 and 108, The drive mechanism for the rotary shaft is remotely located somewhere inside the patient's body. The rack is formed directly or indirectly on the injection needle 11 and on the turntable 20. Threading, for example in the form of a worm screw, which meshes with the teeth of 111 and 112 109, 110. Thus, in some cases, the worm screw 109 and The rotation of the rotary shaft 107 by the cooperation of the rack 111 causes the injection needle 11 Similarly, by rotating the rotating shaft 108, the rotor The injection needle 11 is inserted into the turntable 20 by the action of the screw 110 and the rack 112 of the turntable 20. The rotating shaft 107 is again moved transversely in one direction or the other. , 108 are guided within a common sheath 103 together with a conduit 119 for the infusion fluid.

[0101] In FIG. 16 and FIG. 17, the pull wires 105, 106 and the rotating shaft 108 are operated. The operation allows for the separation of the first penetration between two different penetration areas and / or within a single penetration area. The tip of the injection needle 11 can be moved transversely from the site to the second penetration site. .

[0102] FIG. 18 shows a system including any one of the first to tenth embodiments described above. The first variant of the overall system is shown in FIG. 18. 11, a housing with a single injection needle 11 and a drive unit D. The housing 12 is a catheter that is positioned adjacent to the corpora cavernosa 6, 7. 18. The image is embedded with two window regions 14, only one of which is shown in FIG. A motor M for driving a drive unit D is contained within the housing 12. The motor M in the housing 12 is connected to a control unit which constitutes the embeddable part of the control system. C2, the control system gives the control unit C2 commands and any other The device further includes an external data processing device C1 capable of transmitting various types of data. The data processing device C1 may be used to initiate an injection cycle from outside the patient's body. This is done wirelessly as indicated by arrow 23. The unit C2 not only controls the motor M inside the housing 12 but also the accumulator It also controls the energy supply from A to the motor M in the housing 12.

[0103] Similarly, an external data processing device C1 programs the embedded control unit C2. Also, the external data processing device C1 and the embedded control unit The data transfer port for transferring data between unit C2 and unit C3 transfers data in both directions. The device may be adapted to:

[0104] A feedback sensor F is implanted inside the patient's penis, herein referred to as a housing. 12 is shown connected to a motor M inside the actuator 12, which may also be connected to an embeddable control unit 14. The feedback sensor F can be connected to the sensor C2. one or more of the patient's characteristics, such as drug levels, flow through the corpus cavernosum, and pressure within the corpus cavernosum It can sense the physical parameters of the system, such as electrical parameters, expansion, distance, etc. Other feedback sensors can be installed at different locations to sense the process parameters of the system. It is okay.

[0105] A conduit 19 connecting the needle 11 to a reservoir comprising compartments R1 and R2, and Wiring 24 for transmitting the energy from the energy source A to the motor M inside the housing 12 are guided through a common conduit 25.

[0106] In a variation of the overall system shown in FIG. 18, the reservoir contains, for example, saline. A first compartment R1 contains water and a drug, for example in powder or lyophilized form, is contained therein. The pump P driven by the second motor M2 is The pump P is arranged to pump the injection fluid from the reservoir R1 to the injection needle 11. The infusion fluid pumped through the mixing chamber 26 contains the drug is released from the reservoir R2 at the appropriate time. The motor M2 may be controlled by the control unit. Therefore, the mixture is also controlled by the first reservoir R1, which is relatively large. The injection liquid pumped via pump P to chamber 26 is mixed in the second chamber 26. The drug is mixed with the drug released from the reservoir R2 and reaches the injection needle 11, and at the same time, the injection The needle 11 penetrates the self-sealing window area 14 of the housing 12, and the injection fluid enters the corpus cavernosum 7. Flows into.

[0107] In addition to or instead of the control unit C2, a motor M and and / or a pressure sensitive switch for activating motor M2 may be placed subcutaneously.

[0108] The embodiment shown in FIG. 18 may include one of a variety of types of reservoirs, but the particular The volume of the reservoir R1 is divided into two sections by a membrane 31. One section is filled with gas and the other with injectate (saline). The reservoir R1 is replenished with the injection liquid by a refill needle via the injection port 32. When reservoir R1 is filled, the gas section is at atmospheric pressure or overpressure. When the injection liquid is drawn from the reservoir R1 by the pump P, the pressure in the gas section increases. Depending on the type of pump P, the pressure drops below atmospheric pressure, i.e. to a negative relative value. It may be advantageous to provide a single acting ball valve to prevent backflow into reservoir R1. be.

[0109] There are various ways to supply energy to the motors M and M2. In a variant, the energy is used directly by the motor and / or stored in a Accumulator A is charged from outside the patient's body, and accumulator B is a rechargeable battery and The external primary energy source E may take the form of a first form of Energy conversion equipment that converts energy into a second form of energy, such as electrical energy The device T transmits a first form of energy through the patient's skin 100. recharges, on demand, accumulator A, which supplies secondary energy to motor M Used for:

[0110] Does the external primary energy source E generate an external field, such as an electromagnetic field, a magnetic field, or an electric field? or adapted to generate a wave signal, such as an electromagnetic wave signal or a sound wave signal. For example, the energy conversion device T shown in FIG. 19 can be used as a solar cell. It may work but may be adapted to the particular type of wave signal of the primary energy source E. The energy conversion device T may also be adapted to convert temperature changes into electrical energy. good.

[0111] Instead of an external primary energy source E, a conventional long-life battery instead of an accumulator A, etc. Any implantable primary energy source E may be used.

[0112] The energy signal also determines whether the energy is transmitted wirelessly or via wires. Regardless, the energy signal can be appropriately modulated to provide a signal to the external data processing device C1 The energy signal is used to transmit the signal from the digital control signal or analog The control signal also serves as a carrier signal for the log control signal. More specifically, the control signal is a frequency signal, It may be a phase and / or amplitude modulated signal.

[0113] FIG. 19 is a schematic diagram of a motor M according to the embodiment of the present invention; 1 shows a second variant of the overall system, which is fundamentally different from the system shown in FIG. 1. Instead, the motor M 2 is used to drive the drive unit D. This is a resiliently bendable worm. The rotation shaft 30 is shown in FIG. It replaces the wiring 24 of the system shown in FIG.

[0114] Figure 20 shows a third variant of the overall system, which operates purely mechanically. That is, the reservoir R1 containing the physiological saline is of the balloon type, whereby the reservoir It also functions as a reservoir when manually compressed from outside the patient's body. The pressure generated in 1 acts on a reservoir R2 containing the drug. When this occurs, the drug is released from reservoir R2 into the mixing chamber 26, and as the pressure increases further, The infusion fluid enters the mixing chamber 26 and is mixed with the drug released from the reservoir R2. The flow of the fluid toward the inlet needle 11 causes the drive unit D to drive the inlet needle 11 through the self-sealing window area 14. Pressure is increased within the injection needle 11 to advance it through the patient's corpus cavernosum. When the needle 11 is removed, the needle 11 automatically retracts due to a mechanical spring force or the like, and the reservoir R1 is When compressed again, a different type of opening can penetrate the second of the two self-sealing window areas 14. When the two injection needles 11 are provided in the housing 12, the reservoir A single compression maneuver on R1 was sufficient to inject the drug into both the left and right corpora cavernosa.

[0115] FIG. 21 illustrates how the drug in the multiple compartments 34 of the reservoir R2 is delivered in a purely hydromechanical manner. This shows the first principle of how the solution can be used to release the liquid one by one. is forced from the reservoir R1 towards a conduit 19 leading to one or more injection needles. The injection fluid is first introduced into the injection chamber by a spring-loaded ball valve 34 which opens only when a certain pressure is exceeded. The pressure increasing in front of the ball valve 34 is divided into several sections by the step valve V. Each compartment is formed as a cavity 35 inside a piston 36. Above a certain pressure, the piston 36 causes the compartment 35 to become the mixing chamber 26. In the state shown in FIG. If the pressure in reservoir R1 is further increased, the pressure When the spring force of the ball valve 34 is exceeded, the injection fluid is forced from the reservoir R1 toward the conduit 19. carries the drug released into the mixing chamber 26 .

[0116] 22 to 24 show a reservoir R with multiple small drug compartments 35, 35a, 35b. The second principle for realizing the second embodiment is shown in FIG. 2. The drug compartment is integrally formed in the tape 201. 201 is wound around a first reel 202 and unwound from the first reel 202. The tape can be wound on a second reel 203. 201 is a cassette that can be inserted into the overall system to form part of the reservoir. The cassette 200 is preferably replaceable.

[0117] As shown in FIG. 23, a compartment 35 containing a drug, for example in powder or lyophilized form; 35a, 35b are arranged in rows in the transport direction (indicated by the arrows). However, the compartments 35 in one row are located in the transport direction from the compartments 35a and 35b in the other row. Therefore, the tape 201 is wound from the reel 202 to the reel 203. When attached, the tape 201 guides the infusion fluid from the reservoir R1 into one or more infusion needles. The pump is guided through a conduit 204 forming part of the cassette 200 to be pumped into compartment 3. 5, 35a, and 35b enter conduit 204 in turn.

[0118] Section 3 entering the conduit 204 by mechanical action such as a hammering or piercing element It is possible to open one of the openings 35a, 35b shown in Figs. 22 to 24. In this embodiment, the compartment 35 can be opened by simply winding the tape 201 onto the reel 203. No further manipulation is necessary. That is, as can be seen from FIG. When the air enters the conduit 204 through the slit 205, the slit 205 is relatively wide and the air enters the conduit 204 through the slit 205. The compartment 35 is closed by two soft sealing lips 206 so that it is not damaged. However, when the tape 201 exits the conduit 204 on its other side, the tape 201 It passes through a second slit 207, narrower than slit 205, having a non-elastic front end 208. The compartment 35 must therefore be slid between the ends 208 of the narrow slit 207. When the liquid enters the conduit 204, it will jump out of the conduit 204. The soft seal 209 of the slit 207 prevents the liquid from entering the conduit 204. Prevents leakage from conduit 204.

[0119] The inlet 210 and outlet 211 of the conduit 204 inside the cassette 200 are It closes automatically when the cassette 200 is removed from the system and closes automatically when the cassette 200 is installed in the system. This includes a valve that automatically opens when a gas leak occurs, preventing adverse effects on the remaining components of the entire system. This allows the cassette 200 to be replaced without causing any damage.

[0120] 25 and 26 show a third embodiment of the present invention, which realizes a reservoir R2 having multiple small drug compartments 35. FIG. 25 shows a cross-sectional plan view taken along the section BB of FIG. 26, and FIG. 26 shows the principle of FIG. A cross-sectional side view of the same is shown along section AA. Compartment 35 contains the drug in powder or lyophilized form. is arranged on a rotatable plate 37. The motor M2 rotates the plate 3 around an axis 38. The motor M2 rotates one reservoir R1 containing physiological saline. Alternatively, a pre-insertion device may be used to align the conduits 39 and compartments 35 one by one, which are connected to multiple injection needles. The energy is transferred from the accumulator A to the It is supplied to the motor M2 via the control unit C1.

[0121] The rotatable plate 37 is attached to a fixed base plate 39. The plate 39 itself is a base plate 39 and a rotatable plate 37 mounted in an outer housing. The cooling device is fixedly mounted within a housing 40 that is thermally insulated from the cooling ring 42. 41 is a cooling liquid surrounding the base plate 39 and the rotatable plate 37. This is to prevent the drug inside compartment 36 from dissolving too quickly. The accumulator A serves to prevent the decomposition of the fuel into the cooling device 41. Supply.

[0122] FIG. 27 shows the general principle of cooling a reservoir R2 containing the drug to be cooled. The device 41 is an electrothermal cooler, i.e. one based on the Peltier effect that consumes electrical energy. It can be a refrigerator type or a refrigerator type. Therefore, the heat energy is The cold part of the cooler 41 is placed on the side to be cooled so that the heat can be dissipated. The warm part of the cooling device 41 is placed on the other side. The extended surface 41a helps to increase the heat dissipation. Moreover, the heat exchange fluid is The thermal energy is transferred to a remote location within the patient's body where the heat is transferred to a specific heat exchange surface 41c. 41b along the extended surface 41a and through the conduit 41b so as to be dispersed into the patient's body via the Good too.

[0123] FIG. 28 shows a different principle for cooling the drug contained in reservoir R2. The two chemicals X1 and X2 are separated from each other in the respective compartments of the cooling device 41. Chemicals X1 and X2, when combined, react with each other in such a way that The reaction consumes energy which is absorbed as heat energy from the surroundings. By means of 41d and 41e, the chemicals X1 and X2 are distributed in a controlled manner to the cooling line 41f. , this cooling line preferably contacts the housing 40 containing the reservoir R2. The chemical mixture X1-X2 transferred in f is returned to the chamber containing the chemicals X1 and X2. but is returned to the other side of the pistons 41d, 41e.

[0124] Another embodiment is shown in Figure 29. Again, in this embodiment, two separate needles are There is one needle for each of the left and right corpora cavernosa. However, in the above-mentioned embodiment Unlike the conventional needle-insertion method, each of the two needles has its own housing 12 implanted in the patient's body. Each of the self-sealing window regions 14 is adjacent to the left and right corpora cavernosa. This principle is shown in more detail in Fig. 30 for one of the two needles. Unit D comprises a piston 50 to which a hollow injection needle 11 is attached. The piston 50 has a first chamber 51a at the front of the piston 50 and a second chamber 51b at the rear of the piston 50. The pressure in the first chamber 51a is increased by a pump P. The pressure in the second chamber 51b corresponds to the pressure applied to the first chamber 51a, but the pressure in the second chamber 51b is maintained at a lower value. The second chamber 51b may be filled with a liquid, such as an infusion liquid, and the liquid may be flexible. The flexible volume 52 may be easily filled without creating a strong reaction force. It can be a simple balloon type.

[0125] Instead of a flexible volume 52, a conduit 53 connects the second chamber 51b to the reservoir R1. Thus, when the needle 11 is advanced, liquid is drawn from the second chamber 51b to the The liquid is discharged through the conduit 53 into the reservoir R1, and the needle 11 is retracted by the return spring 55. , liquid is drawn back from reservoir R1 through conduit 53 into second chamber 51b.

[0126] The injection process is carried out as follows: The pressure in the first chamber 51a is increased by the pump P. As the force increases, the needle 11 is moved against the force of the spring 55 of the drive unit B. Thus, the tip 13 of the injection needle 11 is fitted into a wall 15 of the housing 12 by a self-sealing window. It penetrates the area 14 and then penetrates the increased fibrosis at the front of the housing. When 55 is fully compressed and the pressure increased by pump P increases further, the first return The ball valve 56 is moved against a second return spring 57 which is stronger than the spring 55. As long as the pressure is kept at a high enough level, the injectate flows from the reservoir R1 through the conduit 19, An empty injection needle 11 is pumped into the patient's body through an outlet located on the side of the needle. When the force is released, the ball valve 56 is closed by the return springs 55 and 57, and then the needle 1 1 retracts to its initial position shown in FIG.

[0127] As the injection needle 11 advances through the outer wall 15 of the housing 12, it penetrates the biological It may be advantageous to not pierce the tissue. Thus, as shown in FIG. A tube 58 may be installed in front of the dough area 14. The cross-sectional shape of the tube 58 is It may be adapted to the cross-sectional shape of the window area 14, i.e. if the window area 14 is rectangular In this case, the tube 58 also has a rectangular cross section.

[0128] The outlet end of the tube 58 is sufficiently narrow to prevent fibrotic growth from spanning the open area. It has a large open area 59. Fibrosis appears to have a window area after a relatively long time. It slowly grows inside the tube along the inner surface of the tube until it reaches needle 11. The tip 13 of the catheter therefore does not need to penetrate the fibrosis immediately after implantation of the system. Alternatively, the open area 59 has an opening width of at least 3 mm. The length of the tube 58 is The opening width 59 and the length of the tube 58 may range from 4 mm to 30 mm. The material injected into the tube 58 should be adjusted so that it can penetrate safely into the patient's body. Therefore, the longer the tube, the larger its opening width should be.

[0129] 32A and 32B show an example in which the tip of the infusion needle 11 is moved in two or more different directions. That is, a first embodiment for moving in two dimensions is shown. More specifically, FIG. 32B shows a schematic side elevational view of the injection needle 11. A fixedly mounted plate 60 has a projection 61 extending into a frame 62. 61 is free to move in any direction within the frame 62. The electromagnetic coil 63 is The electromagnetic coil 63 is a first part of the electromagnetic drive. and the protrusion 61 is configured to form a second part of the electromagnetic drive device. When one or more of the electromagnetic coils are energized, an electromagnetic field is generated within the frame 62. and the second part of the electromagnet, i.e., protrusion 61, adjusts its position in the electromagnetic field accordingly. Since the injection needle 11 is fixedly attached to the plate 60, the injection needle 11 protrudes 61. In this way, the infusion needle 11 can be advanced and retracted, and can move transversely It can also be moved.

[0130] Of course, the injection needle 11 may be shaped differently, for example in a plane defined by the electromagnetic coil 63. The electromagnetic actuator may be attached at right angles to the actuator (rather than parallel as in FIG. 32B). As a result, the injection needle moves laterally (rather than forward and backward) in multiple directions. It is possible.

[0131] Alternatively, the electromagnetic drive may move the infusion needle in any transverse direction and, in addition, move the infusion needle forward. This may be, for example, a device for moving the tip of the injection needle 11 forward and backward. This is achieved by the structure shown diagrammatically in FIG. 32C, which relates to a second embodiment for FIG. 32C shows a side elevational view similar to FIG. 32B, but with a single electromagnetic coil 63. By providing an additional electromagnetic coil 63 in the vertical direction, the upper and lower A top view is similar to FIG. 32A. In this way, the needle 11 has a plurality of faces defined thereon. The fixedly connected second part 61 of the electromagnet responds to the energization of each of the magnetic coils 63. and moves within the three-dimensional frame 62.

[0132] 33A and 33B show an electromagnetic drive for moving the infusion needle 11 in multiple directions. 1 shows a plan view and a side view of a third embodiment of the electromagnet. In this embodiment, the first part of the electromagnet The electromagnetic coil 63 constituting the electrode 61 is disposed on the first surface and is fixed to the injection needle 11 via the plate 60. The second part of the electromagnet, consisting of the protrusion 61, is fixedly connected to the first part of the electromagnet. However, in this third embodiment, In the example, the electromagnetic coils 63 are oriented in different directions. Again, in response to energizing the individual electromagnetic coils, Thus, the second part of the electromagnet, i.e., the protrusion 61, is induced in the electromagnetic field formed inside the frame 62. Adjust its position in the

[0133] The system is designed to be implanted at least in part in the patient's body to help stimulate the human (or animal) The method of treatment includes the steps of incising the skin and arbitrarily incising a first area near the left and right corpora cavernosa. and when the tip of the at least one injection needle penetrates the outer wall of the housing, In the right corpus cavernosum and / or in the two deep arteries of the right and left corpora cavernosum, and / or The implant is placed in the muscle tissue that regulates blood flow to the patient's left and right corpora cavernosa and / or in the two penises. in another type of tissue near the patient's left and right corpora cavernosa, allowing stimulation of the corpora cavernosa to produce an erection At least one injection needle is accommodated within said incised area so as to be able to penetrate the and installing at least one housing after implanting at least a portion of the system. and finally closing the skin.

[0134] When a portion of the system is implanted away from the corpus cavernosum, e.g., at least one limb is A second reservoir is provided at a second location remote from the first location to place the reservoir at a second location remote from the patient's body. The area may be optionally incised, and the conduit may be at least one of the at least two housings. In this case, the reservoir is placed adjacent to the patient's pubic bone. It is preferable to place

[0135] One or more of the following elements accommodate at least one needle within the patient's body: It may be located remotely from one or more housings. - a reservoir for supplying the injection device with a substance to be injected into the patient's body; - a pump (P) for advancing a substance from a reservoir to at least one injection needle; - a drive unit (D) or a drive for driving this drive unit, and / or At least one kW of power for operating the pump (P) or any other energy consuming part of the system. Another motor (M, M2) and - energy storage means (A) for supplying energy to at least one motor; and, - An external energy source (E) or an energy source for contact-transmitting energy to the motor a current-carrying coupling element between the energy storage means (A) and the motor (M, M2); - The motor (M, M2) or the energy storage means (A) or both are connected to an external primary energy source. a motor or energy storage means adapted to be connected to an energy source in a contactless manner; a wireless coupling element for transferring energy to the device or both; - a control unit (C1) for controlling the motors (M, M2); - Wirelessly transmit data from an external data processing device (C2) to the control unit (C1) a data transfer interface for transferring data by - Feedback sensor (F), - a wireless energy conversion means; - An injection port (32) for filling the reservoir (R1). [Explanation of symbols]

[0136] 6, 7 corpus cavernosum; 11 injection needle; 12 housing; 14 Window area; C1 External data processing device; C2 control unit; D drive unit.

Claims

1. An at least partially implantable system for injecting a substance into a patient's body, comprising: 、 At least one injection needle (11) is provided in at least one housing (12), the tip of the injection needle is adapted to penetrate at least one outer wall (15) of the housing; the housing is adapted for implantation within a patient's body; At least one drive unit (D) adapted for implantation in the patient's body, The drive unit has at least one drive shaft for penetrating at least one penetration area of ​​the outer wall. a needle coupled to at least one of the injection needles for advancing and retracting the tip of the injection needle; injecting a substance through said at least one piercing region via at least one injection needle. It is possible to The at least one drive unit drives at least one The system includes a mechanical drive element for transmitting kinetic energy to the injection needle.

2. The mechanical drive element comprises at least one actuator which cooperates directly or indirectly with the injection needle. wherein the injection needle is moved when the rotating shaft is rotated. Item 2. The system described in item 1.

3. 3. The system of claim 2, wherein the rotating shaft is in the form of a worm screw. 。

4. The system according to claim 2 or 3, wherein the rotating shaft is flexibly bendable. Tem.

5. The present invention provides a method for treating a patient having an endoscopic catheter comprising the steps of: The at least one injection needle is fluidly connected to the injection server to deliver the substance to be injected into the patient's body to the injection needle. Supply to a conduit connecting said reservoir (R1, R2) to said at least one injection needle, The rotating shaft has at least one injection needle and at least one of the reservoirs (R1, R2).

5. A system according to any one of claims 2 to 4, extending through connecting conduits.

6. The at least one injection needle penetrates the outer wall (15) of the at least one housing at least slightly. Both are penetrated at two different penetration regions (14), When the rotating shaft is rotated about its axis of rotation, the at least one injection needle The tip of the at least two different penetration regions is inserted from a first penetration region to a second penetration region. into a region and / or into a first region within a single one of the at least two different penetration regions.

6. The method according to claim 2, wherein the first penetration site is moved transversely to the second penetration site. The system is as follows:

7. Rotating the rotating shaft about its axis of rotation advances and / or moves the injection needle.

7. The system of claim 2, further comprising:

8. The mechanical drive element comprises at least one actuator which cooperates directly or indirectly with the injection needle. The system of claim 1 , comprising a wire, the wire being actuated to move the infusion needle.

9. The present invention provides a method for treating a patient having an endoscopic catheter comprising the steps of: The at least one injection needle is fluidly connected to the injection server to deliver the substance to be injected into the patient's body to the injection needle. a conduit connecting said reservoir to said at least one injection needle; The at least one wire is connected to the at least one injection needle. The system according to claim 8, further comprising a reservoir (R1, R2) and a conduit (R3) for connecting the reservoir (R1, R2). Stem.

10. The at least one injection needle penetrates the outer wall (15) of the at least one housing at least slightly. The at least one wire is penetrated at two different penetration regions (14) at the same time, and the at least one wire is pulled. When the needle is pulled, the tip of the at least one injection needle penetrates the at least two different penetration regions. from a first through-hole region to a second through-hole region of the at least two Transversely from a first penetration site to a second penetration site within a single one of the different penetration regions. The system according to claim 8 or 9,

11. At least two, preferably three messenger wires are provided at the tip of the injection needle.

11. The system of claim 10, arranged to allow two-dimensional transverse movement of 。

12. Pulling at least one of the at least one wire advances and displaces the infusion needle.

12. The system according to claim 8, further comprising:

13. An at least partially implantable system for injecting a substance into a patient's body, comprising: 、 At least one injection needle (11) is provided in at least one housing (12), the tip of the injection needle is adapted to penetrate at least one outer wall (15) of the housing; the housing is adapted for implantation within a patient's body; At least one drive unit (D) adapted for implantation in the patient's body, The drive unit has at least one drive shaft for penetrating at least one penetration area of ​​the outer wall. a needle coupled to at least one of the injection needles for advancing and retracting the tip of the injection needle; injecting a substance through said at least one piercing region via at least one injection needle. It is possible to The at least one injection needle penetrates the outer wall (15) of the at least one housing at least slightly. The system is penetrated at two different penetration regions (14).

14. The injection needle is adapted to receive a single instruction or action from a patient and to The system of claim 13 , configured to penetrate two different penetration areas.

15. The at least one drive unit drives the advancement and retreat of the tip of the at least one needle. The retracting action is performed by the tip penetrating the at least two different penetration regions simultaneously or successively.

15. The system of claim 13 or 14, configured to penetrate.

16. A time delay between penetration of a first region and penetration of a second region of the at least two penetration regions. The extension time is less than 120 seconds, preferably less than 60 seconds. system.

17. The at least one injection needle is inserted through a first one of the at least two different penetration regions. and when the at least two different penetration regions are retracted, the at least two different penetration regions begin to advance toward a second region. A system according to any one of claims 13 to 16.

18. An at least partially implantable system for injecting a substance into a patient's body, comprising: 、 At least one injection needle (11) is provided in at least one housing (12), the tip of the injection needle is adapted to penetrate at least one outer wall (15) of the housing; the housing is adapted for implantation within a patient's body; At least one drive unit (D) adapted for implantation in the patient's body, The drive unit has at least one drive shaft for penetrating at least one penetration area of ​​the outer wall. a needle coupled to at least one of the injection needles for advancing and retracting the tip of the injection needle; injecting a substance through said at least one piercing region via at least one injection needle. It is possible to The outer wall (15) has at least one flush hole in the penetration area through which the injection needle can pass. a flap that, when the injection needle is advanced, causes the at least one injection The system is pushed aside by the needle.

19. An at least partially implantable system for injecting a substance into a patient's body, comprising: 、 At least one injection needle (11) is provided in at least one housing (12), the tip of the injection needle is adapted to penetrate at least one outer wall (15) of the housing; the housing is adapted for implantation within a patient's body; At least one drive unit (D) adapted for implantation in the patient's body, The drive unit has at least one drive shaft for penetrating at least one penetration area of ​​the outer wall. a needle coupled to at least one of the injection needles for advancing and retracting the tip of the injection needle; injecting a substance through said at least one piercing region via at least one injection needle. It is possible to The exterior wall includes at least one door in the penetration area, and the at least one door includes A drive device is connected to actively open the door, and the at least one injection needle is connected to the open door. A system through which you can move forward.

20. The drive device connected to the door is a part of the drive unit coupled to the injection needle. The system of claim 19 , comprising:

21. 21. The door according to claim 19 or 20, wherein the door comprises a resilient flap that is normally closed. system.

22. Any of claims 19 to 21, further comprising at least one spring element biasing the door to a closed position.

2. The system according to claim 1 .

Images