Abstract
A method of implanting a penis erection stimulation system into a patient's body comprises cutting the skin of the patient body, dissecting free an area near the left and right corpus cavernosum, placing a drug delivery device within the dissected area and placing at least one infusion needle of the drug delivery device in a first position in the patient's body in between the left and right corpus cavernosum.
Claims
1. A method of implanting a penis erection stimulation system in a patient's body, comprising a fully implantable drug delivery device adapted to deliver a drug in relation to a penis to achieve erection of the penis, wherein the drug delivery device comprises at least one infusion needle adapted to be placed outside a left or a right corpus cavernosum in close proximity thereto, wherein the fully implantable drug delivery device is adapted to be non-invasively powered, when implanted, wherein the infusion needle is adapted to be advanced into and retracted from, as well as deliver at least one drug when advanced into, at least one of: the left or right corpus cavernosum, one or two of deep arteries thereof, muscle tissue regulating blood flow through the right, left or both corpus cavernosum, and tissue in close proximity to the left, right or both corpus cavernosum, and whenever the needle is or has been advanced, when the drug delivery device is implanted, the at least one infusion needle is further configured to fit in a position in between the left and right corpus cavernosum at a base of penile tissue placed inside the patient's body where the left and right corpus cavernosum are deviating away from each other, and wherein the method comprises the step of: cutting skin of the patient's body, dissecting free an area near the left and right corpus cavernosum, placing the drug delivery device within said dissected area arranged next to at least one of: the left and right corpus cavernosum, the two deep arteries of the right and left corpus cavernosum, the muscle tissue regulating blood flow through the left and right corpus cavernosum and another kind of tissue in close proximity to the left and right corpus cavernosum, so as to allow for stimulation of the penis erection by delivering the drug, and placing the at least one infusion needle in a first position in the patient's body in between the left and right corpus cavernosum at the base of the penile tissue placed inside the patient's body where the left and right corpus cavernosum are deviating away from each other.
2. The method of claim 1, comprising the steps of: implanting at least one housing having an outer wall and including the at least one infusion needle arranged for allowing to penetrate the at least one housing's outer wall in said first position, and implanting placed in the housing at least one drive unit arranged at least for advancing and retracting a tip end of the at least one infusion needle so that postoperatively the at least one infusion needle is able to penetrate said at least one housing's outer wall upon advancement of the tip end or ends thereof, allowing for postoperative stimulation of the penis erection by injecting the at least one drug through the at least one infusion needle on patient command.
3. The method of claim 2, comprising the step of penetrating the infusion needle through the housing's outer wall, into at least one of the left and right corpus cavernosum, the muscle tissue regulating blood flow through at least one of the left and right corpus cavernosum and into the another kind of tissue in close proximity to the left and right corpus cavernosum.
4. The method of claim 2, comprising the step of securing the corpus cavernosum to the housing by means of a holder connected to the housing.
5. The method of claim 2, wherein the drive unit is configured to at least postoperatively laterally displace a tip end of at least one of said at least one infusion needle in at least two different lateral directions to different penetration sites within at least one penetration area, and wherein the at least one infusion needle is arranged for penetrating the at least one housing's outer wall at said different penetration sites in said at least one penetration area.
6. The method of claim 5, further comprising penetrating the at least one housing's outer wall, during operation or postoperatively, by the at least one infusion needle at said at least two different penetration sites, in said at least one penetration area in accordance with at least one of, upon a single command or single action: simultaneously both penetration areas, and both penetration areas in immediate time succession.
7. The method of claim 2, wherein the step of implanting the infusion needle comprises the step of implanting the at least one infusion needle being flexibly bendable, wherein the tip end of each of the at least one infusion needle is arranged for penetrating the outer wall of a first one of the at least one housing and the other end thereof is arranged in a second one of said at least one housing for remote implantation inside the patient's body, the method further comprising the step of implanting the flexibly bendable injection needle being sufficiently long to bridge a distance from the second housing for remote implantation to the first housing and further through the first housing up to the outer wall of the first housing.
8. The method of claim 2, comprising the step of: providing energy by an energy source to at least one of: a pump, the at least one drive unit, a motor and any other energy consuming part of the system, wherein the energy source comprises at least one of: an internal power supply for implantation within the housing implanted in the patient's body, an internal power supply for implantation remote from the housing accommodating the infusion needle implanted in the patient's body, an external power supply adapted to wirelessly transfer energy, and an external power supply for charging an internal power supply from outside the patient's body.
9. The method of claim 1, comprising the further steps of: implanting at least one housing having an outer wall and including the at least one infusion needle arranged for allowing to penetrate the at least one housing's outer wall in said first position, dissecting a second area remote from the first area and placing at least one reservoir in the patient's body in the remote second area, connecting the reservoir, using a conduit, with the at least one infusion needle accommodated in the at least one housing.
10. The method of claim 9, comprising the step of placing the reservoir adjacent to a symphyseal bone or pelvic bone of the patient's body.
11. The method of claim 9, further comprising the steps of placing an injection port for refilling the reservoir, allowing the later step of replenishing the implanted reservoir by penetrating a replenishing needle through the injection port and injecting a substance through the replenishing needle directly or indirectly into the reservoir, wherein at least in the penetration area or areas the at least one housing's outer wall is made from a material which is self-sealing in respect of penetrations resulting from said at least one infusion needle, wherein the self-sealing material comprises a penetration membrane integrated in the at least one housing's outer wall by being sealingly press-fitted into the at least one housing's outer wall, wherein the at least one infusion needle has a tube-like body closed at the tip end and having a laterally arranged delivery exit port.
12. The method of claim 1, further comprising the step of placing one or more of the following elements within the patient's body: at least part of a drive unit, and at least one motor for actuation of at least one of: the drive unit, a drive driving the drive unit, a pump, and any other energy consuming part of the system.
13. The method of claim 12, further comprising the steps of placing one or more of the following elements within the patient's body: an implantable energy storage for providing the at least one motor or any other energy consuming part of the system with energy, wireless coupling elements adapted to receive wireless energy and connect to the motor, the energy storage or any other energy consuming part of the system, and a wireless energy transforming, device adapted to receive wireless energy from an extracorporal wireless primary energy source and adapted to transform wireless energy into a different second form energy, to supply energy to the motor, the energy storage, or any other energy consuming part of the system.
14. The method of claim 1, further comprising the steps of placing one or more of the following elements within the patient's body: a reservoir, and a pump.
15. The method of claim 1, further comprising the steps of placing one or more of the following elements within the patient's body: a control unit for controlling the drug delivery device, and a feedback sensor giving feedback to the control unit.
16. The method of claim 15, further comprising the steps of placing a data transmission interface within the patient's body, allowing to postoperatively be able to at least one of: transfer data between an external data processing device and a data transfer port of the control unit, program the control unit via the data transfer port, transfer feedback data from the control unit to an external data processing device, transfer a feedback signal from the feedback sensor to the control unit, control the system in relation to the feedback signal by the control unit, and program the control unit by means of the external data processing device in relation to received feedback data.
17. The method of claim 15, comprising the steps of: sensing by the feedback sensor one or more parameters of a group of parameters relating to: drug level, flow volume in a blood vessel, pressure, electrical parameters, distension, distance, and a parameter related to a charging process from inside the patient's body to an external power supply for controlling the charging process, and providing feedback on parameters relevant for the treatment sensed by the feedback sensor, including at least one of one or more physical parameters of the patient and process parameters of the system.
18. The method of claim 1, further comprising during operation or postoperatively the steps of: adjusting an amount of wireless energy transmitted by an energy transmitter in relation to a feedback information, wherein a feedback signal comprises feedback information relating to at least wireless energy to be stored in an energy storage, sending feedback information wirelessly from inside the patient's body to the outside thereof relating to at least one of: the wireless energy to be stored in the energy storage, and an energy balance which is defined as the balance between an amount of wireless energy received inside the patient's body and an amount of energy consumed by all implanted energy consuming parts of the penis erection stimulation system, and using the feedback information for adjusting the amount of wireless energy transmitted by the energy transmitter.
19. The method of claim 1, comprising the step of implanting at least one reservoir inside the patient's body to store the drug to be delivered, wherein the reservoir comprises at least one first compartment accommodating or adapted to accommodate a first substance and at least one second compartment accommodating or adapted to accommodate a second substance, further allowing to mix the first substance from the at least one first compartment with the second substance from the at least one second compartment, wherein the second substance contained in the at least one second compartment is in at least one of: powder form, and freeze-dried form, wherein the at least one second compartment is liquid-tightly sealed against the at least one first compartment, wherein the system further comprises a mechanism for individually opening a connection between the at least one second compartment and the at least one first compartment.
20. The method of claim 1, comprising the step of, controlling by a control unit at least one of: an amount of the drug to be delivered into the patient's body, a pump, a drive unit, a motor, and any other energy consuming part of the system, wherein the control unit comprises at least one of: an external component for controlling the system from outside the patient's body, an implantable component adapted to receive a signal from the external component, and a switch so as to be manually operable by the patient when the switch is implanted subcutaneously in the patient's body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 shows the muscles of the perineum,
(2) FIG. 2 shows a cross-section through the penis,
(3) FIG. 3 shows a top view of a first embodiment of the invention including a single needle,
(4) FIG. 4 shows a top view of a second embodiment of the invention including a single needle and a motor accommodated in a common housing,
(5) FIG. 5 shows a top view of a third embodiment of the invention including two needles in a common housing,
(6) FIG. 6 shows a plan view of a part of the drug delivery device of FIGS. 4 and 5,
(7) FIG. 7 shows a cross-sectional view of a penetration membrane made from a composite material,
(8) FIG. 8 shows a cross-sectional view through the outer wall with flaps in the penetration area,
(9) FIG. 9 shows a cross-sectional view through the outer wall with an actively openable door in the penetration area,
(10) FIG. 10 shows a cross-sectional view through the outer wall with an actively openable door according to another embodiment,
(11) FIG. 11 shows a fourth embodiment including a plurality of needles within a common housing,
(12) FIG. 12 shows a side view of a fifth embodiment of the invention comprising a single needle which is laterally and vertically displaceable,
(13) FIG. 13 shows a side view of a sixth embodiment of the invention similar to the fifth embodiment, but with more steps for laterally displacing the needle,
(14) FIG. 14 shows a seventh, spherical embodiment of the invention for obtaining a three-dimensional array of penetration sites,
(15) FIG. 15 shows a side view of an eighth embodiment of the invention comprising two needles in a common housing which are laterally and vertically displaceable,
(16) FIG. 16 shows a side view of a ninth embodiment of the invention comprising two needles similar to the eighth embodiment, but with more steps for laterally displacing the needle,
(17) FIG. 17 shows a tenth embodiment with a principle of advancing and retracting an infusion needle by means of a pull wire,
(18) FIG. 18 shows an eleventh embodiment with a principle of laterally displacing an infusion needle by means of pull wires,
(19) FIG. 19 shows a twelfth embodiment with a principle of advancing and retracting a needle and laterally displacing a needle by means of rotating shafts,
(20) FIG. 20 shows the overall system of the invention implanted in a patient's body according to a first variation,
(21) FIG. 21 shows the overall system of the invention implanted in the patient's body according to a second variation,
(22) FIG. 22 shows the overall system of the invention implanted in the patient's body according to a third variation,
(23) FIG. 23 shows drug compartments as part of the reservoir of the system according to a first principle,
(24) FIG. 24 shows drug compartments mounted on a tape wound on a reel in a replaceable cassette as part of the reservoir of the system according to a second principle,
(25) FIG. 25 shows a part of the tape of FIG. 20 in greater detail,
(26) FIG. 26 shows the principle of operation of the replaceable cassette of FIG. 24,
(27) FIG. 27 shows drug compartments as part of the reservoir of the system according to a third principle,
(28) FIG. 28 shows a cross-sectional view of the drug compartments of FIG. 27 including an insulation chamber and cooling device,
(29) FIG. 29 shows the principle of the cooling device of FIG. 28 in combination with a heat exchanger,
(30) FIG. 30 shows a specific embodiment for the cooling device of FIG. 28,
(31) FIG. 31 shows a part of the system implanted in the patient's body comprising separate needles for the right and the left corpus cavernosum,
(32) FIG. 32 diagrammatically shows the system of FIG. 31,
(33) FIG. 33 diagrammatically shows the system of FIG. 30 with a long, flexibly bendable infusion needle,
(34) FIG. 34 shows a part of the system of FIGS. 32 and 33, respectively, including a tube into which the needle can be advanced,
(35) FIGS. 35A to 35C show a first and second embodiment for electromagnetically displacing the infusion needle in a plurality of lateral directions,
(36) FIGS. 36A and 36B show a third embodiment for electromagnetically displacing the infusion needle in a plurality of lateral directions,
(37) FIG. 37 shows the overall system of the invention implanted in a patient's body according to a fourth variation,
(38) FIG. 38 shows the overall system of the invention implanted in the patient's body according to a fifth variation, and
(39) FIG. 39 shows the overall system of the invention implanted in the patient's body according to a sixth variation.
DETAILED DESCRIPTION OF THE DRAWINGS
(40) FIG. 1 shows the muscles of the perineum of a male. Reference numerals 1, 2 and 3 designate the ischiocavernosus muscles, bulbospongiosus muscles and superficial transverse perineal muscles, respectively. The bulbospongiosus muscle surrounds lateral aspects of the bulb of the penis at the most proximal part of the body of the penis inserting into the perineal membrane, and further surrounds the dorsal aspect of the corpus spongiosum 4 surrounding the urethra 5 and the left and right corpora cavernosa 6, 7. The ischiocavernosus 1 embraces the crus of the penis, inserting onto the inferior and medial aspects of the crus and to the perineal membrane medial to the crus. While the bulbospongiosus muscle assists the erection by compressing outflow via the deep perineal vein and by pushing blood from the bulb into the body of the penis, the ischiocavernosus muscle 1 maintains erection of the penis by compressing outflow veins and pushing blood from the root of the penis into the body of the penis. FIG. 2 is a cross-sectional view through the penis. As can be seen, the penis is composed of three cylindrical bodies of erectile cavernous tissue: the paired corpora cavernosa 6, 7 dorsally and the single corpus spongiosum ventrally. Deep arteries 9, 10 run distally near the center of the corpora cavernosa, supplying the erectile tissue in these structures. The deep arteries of the penis are the main vessels of the cavernous spaces in the erectile tissue of the corpora cavernosa and are therefore involved in the erection of the penis. They give off numerous branches that open directly into the cavernous spaces. When the penis is flaccid, these arteries are coiled, restricting blood flow.
(41) For reasons of simplification, the following figures only display the corpora cavernosa 6, 7. FIG. 3 shows a top view on a part of the system according to a first embodiment. More specifically, a single infusion needle 11 is arranged in a housing 12 with a tip end 13 of the needle 11 being positioned such that it can be advanced and retracted through a self-sealing window area 14 in the housing's 12 outer wall 15 in a longitudinal direction 16, so as to pierce the corpus cavernosum 6 or 7 located adjacent the window area 14.
(42) Two window areas 14 are provided in the outer wall 15 of the housing 12, one adjacent each of the two corpora cavernosa 6, 7. The infusion needle is displaceable in a lateral direction 17 between the two window areas 14 by means of a drive unit D. The same drive unit D or a different drive unit may cause the infusion needle 11 to be advanced and retracted. For this purpose, the infusion needle 11 is mounted on a slide 18 for longitudinal advancement and retraction. A conduit 19 is connected to one end of the infusion needle 11 to supply infusion liquid through the infusion needle 11 to the tip end 13 thereof.
(43) In operation, the infusion needle 11 will first be advanced with the tip end 13 thereof to penetrate one of the two self-sealing penetration windows 14, injection fluid containing a drug for stimulation of penis erection will be injected into the corpus cavernosum 7 through the infusion needle 11 and, thereafter, the infusion needle 11 will be retracted again. Upon retraction of the infusion needle, the infusion needle will be laterally displaced along the direction 17 so that the tip end 13 thereof comes to lie in front of the other of the two self-sealing window areas 14, the infusion needle 11 will be advanced again so that infusion liquid can be injected through the tip end 13 thereof into the other corpus cavernosum 7 and then the infusion needle 11 will be retracted again. At the end of this procedure, the infusion needle 11 will return to its initial position shown in FIG. 3.
(44) The structure of the system shown in FIG. 3 may be purely mechanical. For instance, as will be described in more detail below, the pressure with which the infusion liquid is advanced through the conduit 19 towards the needle 11 may in cooperation with spring elements cause the needle 11 to be advanced, retracted and laterally displaced to the other window area 14. Thus, after two pulses of injection fluid advanced through the conduit 19 towards the needle 11, the needle 11 will automatically return to its starting position shown in FIG. 3.
(45) However, it is likewise possible to incorporate a motor M or a plurality of motors M within the housing 15 in order to achieve the desired needle displacement by means of the drive unit D. This is schematically shown in FIG. 4. Of course, the motor M will have to be provided with energy and will need to be controlled in an appropriate manner so as to obtain the desired effect. This is not specifically shown in FIG. 4. The energy is preferably transmitted to the motor M from an energy source either remotely implanted inside the patient's body or provided externally of the patient's body.
(46) The drive D may be configured such that after each penetration cycle (consisting of two injections) the infusion needle 11 stops at a position different from the starting position so that the tip end 13 thereof penetrates the window areas 14 in the next following injection cycle at different sites as compared to the foregoing injection cycle.
(47) FIG. 5 shows a top view on a third embodiment which differs from the first and second embodiments in that it comprises two infusion needles 11 contained in the housing 15. Thus, when infusion liquid is guided through the conduit 19 towards the two infusion needles 11, both needles are advanced and retracted simultaneously along the direction 16, so that injection of infusion liquid occurs at exactly the same time. The drive unit D or a separate drive unit may be used to turn the turntable 20 on which the infusion needles 11 are mounted, stepwise in the direction 17 so that the window areas 14 will be penetrated by the tip end of the infusion needle 11 at different penetration sites during the next following injection cycle. Again, one or more motors M, not shown in FIG. 5, may be used for driving one or more of the components of the drive unit D.
(48) The principle of a guide structure for laterally displacing the infusion needle will now be described in context with FIG. 6. Such guide structure may be used e.g. for each of the two infusion needles 11 shown in FIG. 5 or may also be used slightly modified for the lateral displacement of the infusion needle 11 shown in FIGS. 3 and 4.
(49) The guide structure 28 is securely fixed adjacent the self-sealing window area 14 which itself is implanted adjacent the patient's corpus cavernosum 7. The guide structure 28 comprises a guide pin 27 securely connected to the infusion needle 11 (not shown) such that the infusion needle 11 cooperates with the guide structure 28. Upon advancement or retraction of the infusion needle 11, the guide pin 27 will be guided in the guide structure 28 and thereby laterally displace the infusion needle 11, which lateral displacement causes rotation of the turntable 20 (not shown in FIG. 6). Resilient flaps 28a, 28b within the guide structure 28 serve to guide the guide pin 27 through the entire guide structure 28 upon repeated advancement and retraction of the infusion needle 11. The guide structure 28 is designed to provide different penetration sites through the self-sealing window area 14 into the corpus cavernosum 7. Where it is desired, the trajectory of guide structure 28 may include a return path 28c for the guide pin 27 to return to its starting position shown in FIG. 6. Such return action will be caused by a return spring 29 which is permanently fixed to a rigid part of the housing 15.
(50) The same structure can likewise be used in the embodiments shown in FIGS. 3 and 4 to displace the single infusion needle 11 laterally between the two window areas 14. Of course, the structure would have to be slightly adapted to accommodate for the larger distance to be overcome between the two window areas 14.
(51) FIG. 7 shows a preferred embodiment of a penetration membrane to be used as the self-sealing window area 14 in the outer wall 15 of the housing 12. The penetration membrane 30 is made from a composite material. The same material can also be used for other flexible wall portions or for an infusion port that will be described below in connection with another embodiment. The composite material of penetration membrane 30 shown in FIG. 7 comprises an outer shape-giving layer 30a defining a volume in which a self-sealing soft material 30b is contained. Self-sealing soft material 30b can be of gel type having a viscosity such that it does not flow through any penetrations caused by the infusion needle 11 during penetration of the outer shape-giving layer 30a. Instead of a single outer shape-giving layer 30a, the shape-giving layer 30a may comprise a plurality of layers. The outer shape-giving layer 30a preferably comprises silicone and/or polyurethane, since such materials can be produced to have self-sealing properties in respect of penetrations resulting from the infusion needle 11.
(52) Instead of a self-sealing membrane, the window area 14 in the outer wall 15 of the housing 12 may be formed by one or more flaps, as shown in FIG. 8. Two flaps 30′ being made from a resilient, biocompatible material are arranged so as to form a slit which is normally closed and through which the infusion needle 11 can pass when it is advanced. Upon advancement of the infusion needle 11, the needle will push aside the normally closed flaps 30′, and when the needle 11 is retracted again, the flaps 30′ will return to their normally closed position so as to form a seal against ingression of body liquid.
(53) FIG. 9 shows a different embodiment. In this case, the self-sealing window 14 in the outer wall 15 comprises a door 30″ which can be opened by mechanical action. In the embodiment shown, the door is formed by a flap made from a resilient, biocompatible material which keeps the window area 14 closed in its normal position. A pull wire 300 is attached to one end of the door 30″ in order to allow for opening the door by pulling the pull wire 300. The pull wire 300 or any other drive connected to the door 30″ forms part of the drive unit coupled to the infusion needle 11. For instance, as is shown in FIG. 10, the pull wire 300 may be attached directly to the infusion needle 11 so that advancement of the infusion needle 11 will simultaneously cause the door 30″ to be lifted up so that the infusion needle 11 can pass underneath the door 30″ and thus penetrate the outer wall 15 easily. Due to the resiliency of the door material, the door 30″ will automatically close when the force, such as the pulling force exerted via the pull wire 300, is released. Instead or in addition, the closing action may be supported by at least one spring element urging the door into its closed position.
(54) FIG. 11 shows a fourth embodiment comprising a plurality of infusion needles for each of the two window areas 14. In this embodiment it is not necessary to provide a turntable by which the needles can be pivoted stepwise in order to laterally displace the needles from one penetration site to a different penetration site within the same window area 14. Instead, upon successive injection cycles a different one of the plurality of injection needles will be advanced and retracted for each of the two window areas 14. Thus, the effect achieved is the same as in the embodiment shown in FIG. 5. However, instead of the turntable 20 (FIG. 5) a valve V is needed to direct the infusion liquid to only one of the plurality of infusion needles 11 in each of the two window areas 14. More specifically, depending upon the position of the valve V, a first one of the infusion needles 11 in the first window area 14 and a first one of the plurality of the infusion needles 11 in the second window area 14 will be advanced and retracted simultaneously, and during the next following infusion cycle, another one of the plurality of infusion needles will be advanced and retracted in the two window areas 14.
(55) FIG. 12 shows a side view of a fifth embodiment which differs from the first and second embodiments shown in FIGS. 3 and 4 in that the single infusion needle 11 is not only laterally displaceable in the direction 17 between the two window areas 14 but also laterally displaceable between different penetration sites 21 within the same penetration area 14. More specifically, the direction of lateral displacement of the tip end of the infusion needle 11 within each of said different penetration areas 14 is perpendicular to the direction of lateral displacement between the different penetration areas 14. To achieve this result, the drive unit D is configured to longitudinally advance and retract the infusion needle 11 along a direction 16, to pivot the infusion needle 11 by means of a turntable 20 between the two penetration areas 14 along a pivoting direction 17 and to raise or lower the infusion needle 11 along a third direction 22 perpendicular to the longitudinal direction 16. A suitable purely mechanical construction may perform this function. However, one or more motors may also be provided to perform one and/or the other of these functions.
(56) FIG. 13 shows a side view of a sixth embodiment similar to the fifth embodiment shown in FIG. 12. In contrast to FIG. 12, the infusion needle 11 is not only laterally displaceable between different penetration sites 21 within the same penetration area 14 in a direction perpendicular to the direction of lateral displacement between the two penetration areas 14, but is also laterally displaceable within the same penetration area 14 in a direction parallel to the direction of lateral displacement between the different penetration areas 14. In other words, the tip end of the infusion needle 11 is laterally displaceable in two dimensions within the same penetration area 14.
(57) FIG. 14 shows a seventh embodiment which enables the infusion needle 11 to be moved along a three-dimensional, spherically curved array of penetration sites. In this embodiment, a part of the housing 12, more specifically the window area 14, is spherically curved and the needle 11 is mounted in a sphere so that upon rotation of the sphere along the directions 17a and 17b the tip end 13 of the needle 11 can be moved to any position in front of the window area 14. Once an appropriate position has been adjusted for the tip end 13, the needle 11 can be advanced on the slide 18 so as to penetrate the window area 14. Instead of accommodating the slide inside the sphere, it may likewise be mounted on the outer surface of the sphere. Similarly, the infusion needle 11 itself can be mounted on the outer surface of the sphere. The mechanism for moving the sphere along the directions 17a, 17b can be of many different types, such as mechanical by means of rollers or magnetic.
(58) FIG. 15 shows a side view of an eighth embodiment similar to the third embodiment shown in FIG. 5. That is, two needles 11 are provided in a common housing so as to be longitudinally movable in order to advance and retract the tip ends thereof through the penetration areas 14. The infusion needles 11 is mounted on a turntable 20, as in the third embodiment of FIG. 5, so as to change the injection sites 22 within a penetration area 14 upon each injection cycle. In addition, the two injection needles can be raised and lowered along a direction 22, similar to the fifth embodiment described above in relation to FIG. 12. Again, the result is that the direction of lateral displacement of the tip ends of the two infusion needles 11 within each of the two different penetration areas 14 is perpendicular to the direction of distance between the two different penetration areas 14. Of course, this embodiment, like the sixth embodiment shown in FIG. 13, can also be modified such that the tip ends of the two infusion needles 11 are laterally displaceable in two dimensions within the same penetration area 14. This is shown in FIG. 16, displaying a side view of a ninth embodiment. In this embodiment, like in the sixth embodiment shown in FIG. 13, the tip ends of the two infusion needles 11 are laterally displaceable in two dimensions within the same penetration area 14.
(59) FIG. 17 shows a tenth embodiment with a principle of advancing and retracting the infusion needle 11 by means of a pull wire 101. The pull wire 101 is redirected about a pin 102 such that by pulling the wire 101 at an end remotely located somewhere in the patient's body the tip end of the infusion needle 11 will be advanced through the window of the housing 12. A helical spring provides a counterforce so that the infusion needle 11 will be retracted once the pulling force on the pull wire 101 is released. This principle can be combined with other embodiments described hereinbefore and hereinafter. Instead of the helical spring 104, a second pull wire may be provided to retract the infusion needle 11. It is even possible to use a single pull wire 101 running around two pins 102 in a loop, so that pulling the wire 101 in the one direction or in the other direction will cause advancement or retraction of the infusion needle 11.
(60) 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, it gives support to the pull wire 101 in bending sections. Second, it facilitates implantation of the conduit 19 along with the pull wire 101. Third, it protects the pull wire 101 against any build-up of fibrosis. In the case that the infusion needle 11 is long and flexibly bendable, the pull wire 101 and the long infusion needle may be guided in the common sheath 103.
(61) FIG. 18 shows an eleventh embodiment which involves remotely actuated pull wires 105, 106 guided within a common sheath 103 along with the conduit 19 for the infusion liquid. The pull wires 105 and 106 are directly attached to the infusion needle 11 on opposite sides thereof so that the infusion needle 11 which is mounted on a turntable 20 will be laterally displaced in the one direction or in the other direction depending on whether the wire 105 or the wire 106 is pulled. Instead of using two wires 105, 106, one of the wires may be replaced with a pretensioning means, such as the helical spring 104 in FIG. 17. In addition, a further wire, in particular third wire (not shown), may be provided for lateral displacement of the infusion needle 11 in a further direction, so that a two-dimensional lateral displacement can be achieved by pulling the appropriate wires.
(62) The pull wires may alternatively be attached to an element other than the infusion needle 11, provided that the infusion needle 11 is connected to such other element, so that when the other element is moved or turned by pulling one or more of the wires the tip end of the infusion needle 11 will be displaced accordingly.
(63) In the case that a long, flexibly bendable needle is provided with the tip end thereof being arranged in a first housing for penetrating the outer wall of the first housing and the other end is arranged in a remotely implanted second housing, one can dispense with the turntable 20 and achieve accurate lateral displacement of the tip end of the needle by pulling the appropriate one of three pull wires which are attached either directly or indirectly to the circumference of the front end of the infusion needle at regularly spaced intervals.
(64) FIG. 19 shows a twelfth embodiment with a different principle of advancing and retracting the tip end of the infusion needle, on the one hand, and laterally displacing the tip end of the infusion needle 11, on the other hand. Instead of pull wires, rotating shafts 107, 108 are provided. The drive for driving the rotating shafts 107, 108 is remotely located somewhere in the patient's body. The front ends of the rotating shafts have a threading 109, 110, e.g. in the form of a worm screw, meshing with the teeth of a rack 111, 112 formed either directly or indirectly on the infusion needle 11 and on the turntable 20, respectively. Thus, by turning the rotating shaft 107, the infusion needle 11 will advance or retract, as the case may be, due to the cooperation of the worm screw 109 and the rack 111. The gearing 109, 111 may likewise be arranged remote from the first housing, i.e. within the second housing accommodating the respective other end of the needle (which is particularly suitable when a long, flexibly bendable needle is used—not shown). Similarly, by turning the rotating shaft 108, the infusion needle 11 will be displaced laterally in the one or the other direction due to the cooperation of the worm screw 110 and the rack 112 of the turntable 20. Again, the rotating shafts 107, 108 are guided in a common sheath 103 along with the conduit 119 for the infusion liquid (or, in the case of a long, flexibly bendable infusion needle, along with the long needle—not shown).
(65) In FIGS. 18 and 19, the action of the pull wires 105, 106 and the rotating shaft 108 make it possible to laterally displace the tip end of the infusion needle 11 between two different penetration areas and/or from a first penetration site to a second penetration site within a single penetration area.
(66) FIG. 20 shows a first variation of an overall system comprising any one of the first to twelfth embodiment described above. Specifically shown in the variation shown in FIG. 20 is a housing 12 with a single infusion needle 11 and a drive unit D as described in relation to FIG. 12. The housing 12 is implanted with its windows areas 14 positioned adjacent the corpora cavernosa 6, 7, of which window areas 14 only one is shown in FIG. 20. A motor M is contained in the housing 12 for driving the drive unit D. While the motor M in the housing 12 may be designed to move the tip end of the infusion needle 11 in all directions as indicated in FIG. 20, it is particularly preferable in context with a long, flexibly bendable infusion needle to cause advancement and retraction of the front end of the long infusion needle by advancing and retracting the entire infusion needle from its rear end using an additional motor, so as to minimize the motor size in the housing 12 for reasons of space constraints in the injection area. The additional motor may be accommodated in a separate second housing—not shown in FIG. 20—along with the rear end of the long infusion needle and possibly along with further components remotely implanted in the patient's body. The motor M within the housing 12 (and likewise the afore-mentioned additional motor) is controlled by means of a control unit C.sub.2 constituting the implantable part of a control system which further comprises an external data processing device C.sub.1 by which commands and any other kind of data can be sent to the control unit C.sub.2. For instance, the external data processing device C.sub.1 may be used to initiate an injection cycle from outside the patient's body, this being done wirelessly as indicated by arrow 23. The implanted control unit C.sub.2 not only controls the motor M inside the housing 12 but also controls the energy supply from an accumulator A to the motor M inside the housing 12.
(67) The external data processing device C.sub.1 may likewise be used to program the implanted control unit C.sub.2. Also, a data transfer port for transferring data between the external data processing device C.sub.1 and the implanted control unit C.sub.2 may be adapted to transfer data in both directions.
(68) A feedback sensor F implanted inside the patient's penis is shown here as being connected to the motor M inside the housing 12 and may likewise be connected to the implantable control unit C.sub.2. The feedback sensor F can sense one or more physical parameters of the patient, such as the drug level inside the corpora cavernosa, the flow volume through the corpora cavernosa, the pressure inside the corpora cavernosa and the like. Other feedback sensors may be provided at a different location so as to sense process parameters of the system, such as electrical parameters, distention, distance and the like.
(69) The conduit 19 connecting the needle 11 with a reservoir comprising compartments R.sub.1 and R.sub.2 and the wiring 24 for transmitting electric energy from the energy source A to the motor M inside the housing 12 are guided through a common conduit 25. Alternatively, where a long and flexibly bendable needle is used, the conduit 19 may guide the long infusion needle 11 between the reservoir and the housing 12.
(70) In the variation of the entire system shown in FIG. 20, the reservoir comprises a first compartment R.sub.1 with e.g. a saline solution included therein, and a second compartment R.sub.2 with e.g. a drug in powder form or freeze-dried form included therein. A pump P driven by a second motor M.sub.2 is arranged to pump infusion liquid from the reservoir R.sub.1 to the infusion needle 11. The infusion liquid pumped by the pump P will pass through a mixing chamber 26 into which drugs will be released from the reservoir R.sub.2 in appropriate time coordination. The motor M.sub.2 or a different motor may cause the drugs to be released from the second reservoir R.sub.2. The motor M.sub.2 is also controlled by the control unit C.sub.2. Thus, infusion liquid pumped via the pump P from the relatively large first reservoir R.sub.1 through the mixing chamber 26, in which it is mixed with the drugs released from the second reservoir R.sub.2, will reach the infusion needle 11 which has meanwhile penetrated the self-sealing window area 14 of the housing 12 and will flow into the corpus cavernosum 7.
(71) In addition to or instead of the control unit C.sub.2, a pressure sensitive switch for activating the motor M inside the housing 12 and/or the motor M.sub.2 may be arranged subcutaneously.
(72) Although the embodiment shown in FIG. 20 may comprise one of a great variety of reservoir types, a particular reservoir type will now be described. The volume of the reservoir R.sub.1 is divided into two sections by means of a membrane 31. One section is filled with gas, as indicated in FIG. 20 and FIG. 21 by GAS, whereas the other section is filled with the infusion liquid (saline solution). An infusion port 32 allows for refilling the reservoir R.sub.1 with infusion liquid by means of a replenishing needle. When the reservoir R.sub.1 is in its full state, the gas section is at ambient pressure or over-pressurized. As infusion liquid is drawn from the reservoir R.sub.1 by means of the pump P upon each infusion cycle, the pressure in the gas section will decrease below ambient pressure, i.e. to a negative relative value. Depending upon the particular type of pump P, it may be advantageous to provide a single acting ball valve to prevent any backflow from the pump P to the reservoir R.sub.1.
(73) There are various ways of providing the motors M and M.sub.2 with energy. In the variation shown in FIG. 20, energy is supplied from outside the patient's body either for direct use by the motors and/or for charging the accumulator A, which may be in the form of a rechargeable battery and/or a capacitor. An extracorporal primary energy source E transmits energy of a first form through the patient's skin 100 to an energy transforming device T which transforms the energy of the first form into energy of a second form, such as electric energy. The electric energy is used to recharge the accumulator A which provides secondary energy to the motor M upon demand.
(74) The external primary energy source E may be adapted to create an external field, such as an electromagnetic field, magnetic field or electrical field, or create a wave signal, such as an electromagnetic wave or sound wave signal. For instance, the energy transforming device T as shown in FIG. 20 may act as a solar cell, but adapted to the particular type of wave signal of the primary energy source E. The energy transforming device T may also be adapted to transform temperature changes into electrical energy.
(75) Instead of the external primary energy source E, an implantable primary energy source E may be used, such as a regular long-life battery instead of the accumulator A.
(76) The energy signal may also be used to transmit signals from the external data processing device C.sub.1 by appropriate modulation of the energy signal, regardless of whether the energy is transmitted wirelessly or by wire, the energy signal thereby serving as a carrier wave signal for the digital or analog control signal. More particularly, the control signal may be a frequency, phase and/or amplitude modulated signal.
(77) FIG. 21 shows a second variation of the entire system which basically differs from the system of FIG. 20 only in that the motor M inside the housing 12 is dispensed with. Instead, the motor M.sub.2 is used to drive the drive unit D. This is achieved by means of a rotating shaft 33 in the form of an elastically bendable worm screw, the rotating shaft 30 replacing the wiring 24 of the system shown in FIG. 20. Alternatively, where the infusion needle 11 is long and flexible, the infusion needle may be advanced by engagement of two helical gears, one of which being formed on the rear end of the infusion needle, or by a similar gearing cooperating with the infusion needle's rear end.
(78) FIG. 22 shows a third variation of the entire system which operates purely mechanically. The reservoir R.sub.1 containing the infusion liquid, i.e. the saline solution, is of balloon type, thereby functioning both as a reservoir and as a pump if it is compressed manually from outside the patient's body. The pressure generated in the reservoir R.sub.1 will act on the reservoir R.sub.2 containing the drug. Upon a certain pressure, the drug will be released from the reservoir R.sub.2 into the mixing chamber 26 and upon further increase of the pressure the infusion liquid will be allowed to enter the mixing chamber 26, mix with the drug released from the reservoir R.sub.2, flow towards the infusion needle 11, and build up pressure on the infusion needle 11 such that the drive unit D is caused to advance the infusion needle 11 through the self-sealing window area 14 into the patient's corpus cavernosum. Once the pressure is released, the infusion needle 11 will retract automatically due to mechanical spring forces or the like and move into a different position in which it can penetrate the second of the two self-sealing window areas 14 when the reservoir R.sub.1 is compressed again. Where two infusion needles 11 are provided, a single compressing action on the reservoir R.sub.1 would be sufficient to inject the drug into both the left and right corpora cavernosa.
(79) FIG. 23 shows a first principle of how drugs within a plurality of compartments 34 of the reservoir R.sub.2 can be released one at a time by a purely hydromechanical solution. As the infusion liquid is urged from the reservoir R.sub.1 towards the conduit 19 leading to the infusion needle or needles, it is first blocked by a spring-loaded ball valve 34 which opens only when a certain pressure is exceeded. The pressure building up in front of the ball valve 34 is guided by means of a stepper valve V sequentially onto one of a plurality of compartments 35. The compartments are each formed as a cavity 35 within a piston 36. Once a certain pressure is exceeded, the piston 36 will be pushed into a position where the compartment 35 is in flow communication with a mixing chamber 26. In the state shown in FIG. 23, three pistons 36 have already been pushed into such position. When the pressure in the reservoir R.sub.1 is further increased, the spring force of the ball valve 34 will be overcome and the infusion liquid urged from the reservoir R.sub.1 towards the conduit 19 will take with it the drug that has been released into the mixing chamber 26.
(80) FIGS. 24 to 26 show a second principle of realizing the reservoir R.sub.2 comprising a plurality of small drug compartments 35, 35a, 35b. The drug compartments are integrally formed in a tape 201 which is wound on a first reel 202 and can be unwound from said first reel 202 onto a second reel 203. The reels 202, 203 and the tape 201 are contained in a cassette 200 which may be inserted in the entire system so as to form part of the reservoir. The cassette 200 is preferably replaceable.
(81) As can be seen in FIG. 25, the compartments 35, 35a, 35b containing the drug e.g. in powder form or freeze-dried form are arranged in a plurality of rows as seen in the transporting direction (indicated by the arrow). However, the compartments 35 of one row are a certain distance offset in the transporting direction from the compartments 35a and 35b of the other rows. Thus, when the tape 201 is wound from reel 202 to reel 203, it is guided through a conduit 204 forming part of the cassette 200 through which the infusion liquid is pumped from the reservoir R.sub.1 to the infusion needle or needles, and the compartments 35, 35a, 35b will enter the conduit 204 one after the other.
(82) While it is conceivable to open one of the compartments 35, 35a, 35b that has entered the conduit 204 by mechanical action, such as a hammer or piercing element, the opening of the compartments 35 in the embodiment shown in FIGS. 24 to 26 needs no further action other than winding the tape 201 onto the reel 203. That is, as can be seen from FIG. 26, when the tape 201 enters the conduit 204 through a first slit 205, the compartments 35 will not be damaged due to the fact that the slit 205 is relatively wide and is closed by two soft sealing lips 206. However, when the tape 201 exits the conduit 204 on the other side thereof, it will have to pass a narrower second slit 207 with front edges 208 that are not resilient. The compartments 35 will therefore burst on their way out of the conduit 204 when they slip between the edges 208 of the narrow slit 207. Soft seals 209 in the slit 207 prevent liquid from leaking from the conduit 204.
(83) The entry 210 and the exit 211 of the conduit 204 within the cassette 200 each include a valve that automatically closes when the cassette 200 is removed from the system and automatically opens when the cassette 200 is installed in the system. This allows for replacement of the cassette 200 without adversely affecting the remaining components of the overall system.
(84) FIGS. 27 and 28 show a third principle of realizing the reservoir R.sub.2 comprising a plurality of small drug compartments 35. While FIG. 27 shows a cross-sectional plan view according to section BB in FIG. 28, FIG. 28 shows a cross-sectional side view thereof according to section AA in FIG. 27. The compartments 35 containing the drug in powder form or freeze-dried form are arranged in a rotatable plate 37. A motor M.sub.2 is provided to rotate the plate 37 about an axis 38. The motor M.sub.2 is controlled to advance the plate 37 stepwise so as to bring one compartment 35 at a time in line with the conduit 39 connecting the reservoir R.sub.1 containing the saline solution with the infusion needle or needles. Energy is supplied to the motor M.sub.2 from the accumulator A via the control unit C.sub.1.
(85) The rotatable plate 37 is mounted in a fixed base plate 39 which itself is fixedly mounted in a housing 40 insulating the base plate 39 and the rotatable plate 37 thermally against an outer housing 42. A cooling device 41 is provided to cool a liquid surrounding the base plate 39 and rotatable plate 37 down to a temperature below 37° C. This serves to protect the drugs inside the compartment 36 from degrading too quickly. The accumulator A supplies the cooling device 41 with energy.
(86) FIG. 29 shows a general principle of cooling the reservoir R.sub.2 containing the drug to be cooled. The cooling device 41 may be an electrothermal cooler, i.e. based on the Peltier effect consuming electric energy, or may be of the refrigerator type. Accordingly, the cold part of the cooler 41 is placed on the side to be cooled whereas the warm part of the cooling device 41 is placed on the other side so that the heat energy can be dissipated to the outside. An increased surface 41a on the warm side of the cooling device 41 serves to increase heat dissipation. Furthermore, a heat exchanging fluid may be passed through a conduit 41b along the increased surface 41a to transfer the dissipated heat energy to a remote location within the patient's body where the heat is dissipated into the patient's body through a specific heat exchanging surface 41c.
(87) FIG. 30 shows a different principle of cooling the drugs contained in the reservoir R.sub.2. In this embodiment, two chemicals X1 and X2 are contained separate from each other in respective compartments of the cooling device 41. When the chemicals X1 and X2 are brought together, they will react with each other and such reaction will consume energy which is absorbed as thermal energy from the surroundings. By means of two pistons 41d, 41e, the chemicals X1, X2 are dispensed into a cooling line 41f in a controlled manner, which cooling line is preferably in contact with the housing 40 containing the reservoir R.sub.2. The chemical mixture X1-X2 displaced within the cooling line 41f will flow back into the chamber containing the chemicals X1, X2, but onto the other side of the pistons 41d, 41e.
(88) A further embodiment is shown in FIG. 31. In this embodiment, again, two separate needles are provided, one infusion needle for each of the left and right corpora cavernosa. However, unlike the previously discussed embodiments, the two needles each have their own housing 12 implanted in the patient's body with their respective self-sealing window area 14 adjacent the left and right corpora cavernosa, respectively. This principle is shown in FIG. 32 in more detail with respect to one of the two needles. The drive unit D comprises a piston 50, to which the hollow infusion needle 11 is attached. The piston 50 separates a first chamber 51a in front of the piston 50 and a second chamber 51b behind the piston 50. While the pressure in the first chamber 51a corresponds to the pressure exerted by the pump P, the pressure in the second chamber 51b can be kept at a lower value. The second chamber 51b may be filled with a liquid, such as the infusion liquid, and the liquid may be urged into a flexible volume 52. The flexible volume 52 could be of simple balloon type so as to fill up without exerting any strong counterforce.
(89) Instead of the flexible volume 52, a conduit 53 may connect the second chamber 51b with the reservoir R.sub.1. Thus, when the needle 11 is advanced, liquid will be dispelled from the second chamber 51b through the conduit 53 into the reservoir R.sub.1, and as the needle 11 is retracted by means of a return spring 55, liquid will be drawn from the reservoir R.sub.1 through the conduit 53 back into the second chamber 51b.
(90) The injection process is carried out as follows. As the pressure is increased in the first chamber 51a by means of the pump P, the needle 11 will be displaced against the force of the spring 55 of the drive unit B. Thus, the tip end 13 of the infusion needle 11 will penetrate through the self-sealing window area 14 press-fitted into the wall 15 of the housing 12 and will further penetrate any fibrosis having built up in front of the housing. When the return spring 55 is completely compressed and the pressure built up by the pump P is further increased, a ball valve 56 will be displaced against a second return spring 57 which is stronger than the first return spring 55. That way, as long as the pressure is held at a sufficiently high level, infusion liquid will be pumped from the reservoir R.sub.1 through the conduit 19, the hollow infusion needle 11 and the needle's laterally arranged exit port into the patient's body. Upon pressure release, the ball valve 56 will close due to the return springs 55 and 57, and then the needle 11 will be retracted to its initial position shown in FIG. 23.
(91) FIG. 33 shows the same principle, however, employing long, flexibly bendable infusion needle with only their respective front ends accommodated in the housing 12. As the pressure is increased in the first chamber 51a by means of the pump P remote from the housing 12 accommodating the tip end 13 of the infusion needle 11, the entire infusion needle 11 which is guided in the conduit 19 will be displaced against the force of the spring 55 of the drive unit B.
(92) It may be advantageous not to pierce any living tissue by means of the injection needle 11 once it is advanced through the outer wall 15 of the housing 12. Therefore, as shown in FIG. 34, a tube 58 may be placed in front of the window area 14. The cross-sectional form of the tube 58 may be adapted to the cross-sectional form of the window area 14, i.e. where the window area 14 is rectangular, the tube 58 likewise has a rectangular cross-section.
(93) The exit end of the tube 58 has an open area 59 sufficiently large to prevent growth of fibrosis from spanning over the open area. Fibrosis will slowly grow into the tube along the tube's inner surface, before it reaches the window area 14 after a relatively long time. The tip end 13 of the needle 11 will therefore not have to penetrate any fibrosis during the first while after implantation of the system. Preferably, the open area 59 has an opening width of at least 3 mm. The length of the tube 58 may be in the range of 4 mm to 30 mm. The opening width 59 and the length of the tube 58 should be adjusted such that the substance injected into the tube 58 can safely seep into the patient's body. Thus, the longer the tube is, the larger the opening width thereof should be.
(94) FIGS. 35A and 35B show a first embodiment for displacing the tip end of the infusion needle 11 in two or more different directions, i.e. a two-dimensional displacement. More specifically, FIG. 35A shows a plan view, whereas FIG. 35B shows a side elevational view schematically. As can be seen, a plate 60 to which the infusion needle 11 is fixedly mounted has a projection 61 extending into a frame 62 within which the projection 61 is free to move in any direction. Electromagnetic coils 63 are mounted on the sides of the frame 62 and are individually energizable. The electromagnetic coils 63 constitute the first part of an electromagnetic drive whereas the projection 61 is configured to constitute the second part of the electromagnetic drive. Thus, when one or more of the electromagnetic coils are energized, an electromagnetic field is created in the frame 62 and the electromagnet second part, i.e. the projection 61, will adjust its position within such field accordingly. Due to the fact that the infusion needle 11 is fixedly mounted to the plate 60, the infusion needle 11 will move along with the projection 61. This way, the infusion needle 11 can be advanced and retracted and can also be displaced laterally.
(95) Of course, the infusion needle 11 may be attached to the electromagnetic drive in a different manner, e.g. perpendicular to the plane defined by the electromagnetic coils 63 (rather than in parallel as in FIG. 35B). As a result, the infusion needle would be laterally displaceable in a plurality of directions (rather than being advanceable and retractable).
(96) Alternatively, the electromagnetic drive may be such as to displace the infusion needle in any lateral direction and, in addition, to advance and retract the infusion needle. This can be achieved e.g. with a structure as schematically shown in FIG. 35C relating to a second embodiment for displacing the tip end of the infusion needle 11. FIG. 35C shows an elevational side view similar to FIG. 35B, but the electromagnetic coils 63 do not define a single plane, but rather a plurality of planes is defined one above the other by providing additional electromagnetic coils 63 in a vertical direction. The top plan view would be similar to FIG. 35A. This way, the electromagnet second part 61 fixedly connected to the needle 11 moves within a three-dimensional frame 62 depending on the energization of respective ones of the magnetic coils 63.
(97) FIGS. 36A and 36B show a plan view and a side view of a third embodiment of an electromagnetic drive for moving the infusion needle 11 in a plurality of directions. In this embodiment, the electromagnetic coils 63 constituting the electromagnet first parts are arranged in a first plane and the electromagnet second part constituted by the protrusion 61 fixedly connected to the infusion needle 11 via the plate 60 is movable in a plane in front of or behind the plane defined by the electromagnet first parts. However, the electromagnetic coils 63 are oriented differently in this third embodiment. Again, depending upon the energization of the individual electromagnetic coils, the electromagnet second part, i.e. the protrusion 61, will adjust its position in the created electromagnetic field within the frame 62.
(98) FIG. 37 shows an overall system of the invention implanted in a patient's body according to a fourth variation. This variation differs from the first to third variations described in relation to FIGS. 21 to 23 in that the infusion needle is not accommodated in a housing so as to be laterally displaceable. The infusion needle 11 is instead guided in a catheter 19 ending inside the patient's corpus cavernosum. Accordingly, two separate needles 11 are provided, which are long and flexibly bendable. They are advanced from the rear ends thereof so as to penetrate a window area 14 at the front end of the catheter, whenever a drug is injected to achieve an erection. While the variation shown in FIG. 37 is purely mechanic, similar to the variation shown in FIG. 23, the overall system may be more complex, e.g. similar to the variations described in relation to FIGS. 21 and 22.
(99) FIG. 38 shows an overall system of the invention according to a fifth variation which is similar to the afore-mentioned fourth variation, except that there is no needle provided in the catheter 19. The substances from the reservoirs R.sub.1 and R.sub.2 are delivered to the corpus cavernosum through the catheter 19. Accordingly, the catheter 19 has an open end or, more preferably, an end that can be opened when needed, e.g. mechanically as described above.
(100) FIG. 39 shows an overall system of the invention according to a sixth variation which is similar to the afore-mentioned fifth variation, except that the catheter does not end in the corpus cavernosum, but ends in close proximity thereto, such as in muscle tissue regulating blood flow through the patient's left and right corpus cavernosum and/or in another kind of tissue in close proximity to the patient's left and right corpus cavernosum. Alternatively, the catheter 19 may guide an infusion needle, such as the infusion needle 11 as described in the fourth variation in relation to FIG. 37. Thus, when the catheter 19 is implanted, the drugs are delivered through the catheter 19 or through the infusion needle 11, as the case may be, outside the corpora cavernosa.
(101) It should be appreciated that the features of all the above described variations and embodiments may be combined and/or inter-exchanged deliberately, unless this is technically impossible.
(102) A method of treating a human being (or an animal) by implanting at least part of the system in the patient's body comprises the steps of cutting the skin, dissecting free an area near the left and right corpus cavernosum, placing the fully implantable drug delivery device within said dissected area with the a least one catheter arranged next to the left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or muscle tissue regulating blood flow through the patient's left and right corpus cavernosum and/or another kind of tissue in close proximity to the patient's left and right corpus cavernosum, so as to allow for stimulation of penis erection by delivering a drug through said at least one catheter, and closing at least the skin after implantation of at least parts of the system.
(103) A method of treating a human being (or an animal) may likewise comprise the steps of cutting the skin, dissecting free the left and right corpus cavernosum, placing the drug delivery device within said dissected area with the a least one catheter ending in the left and right corpus cavernosum and/or the two deep arteries of the right and left corpus cavernosum and/or muscle tissue regulating blood flow through the patient's left and right corpus cavernosum and/or another kind of tissue in close proximity to the patient's left and right corpus cavernosum, so as to allow for stimulation of penis erection by delivering a drug through said at least one catheter, and closing at least the skin after implantation of at least parts of the system.
(104) The method of treating a human being (or an animal) may particularly comprise the steps of cutting the skin, dissecting free a first area near the left and right corpus cavernosum, placing the at least one housing accommodating the at least one infusion needle within said dissected area such that the tip end of the at least one infusion needle can penetrate, when penetrating the housing's outer wall, into at least one of the left and right corpus cavernosum and/or at least one of the two deep arteries of the right and left corpus cavernosum and/or into muscle tissue regulating blood flow to the patient's left and right corpus cavernosum and/or into another kind of tissue in close proximity to the patient's left and right corpus cavernosum allowing stimulation of erection of the two corpora cavernosa, and finally closing at least the skin after implantation of at least parts of the system.
(105) Where parts of the system are implanted remote from the corpora cavernosa, a second area remote from the first area may be dissected free in order to place e.g. the at least one reservoir in the patient's body at the remote second area, with a conduit connecting the reservoir with the at least one infusion needle accommodated in the at least one housing. In this case, it is preferable to place the reservoir adjacent the patient's symphyseal bone.
(106) One or more of the following elements may be placed within the patient's body remote from the housing or housings accommodating the at least one needle: at least part of the drive unit D, the reservoir R.sub.1, R.sub.2, the pump P, at least one motor M, M.sub.2 for actuation of the drive unit D or a drive driving the drive unit, and/or the pump P or any other energy consuming part of the system, energy storage means A for providing the at least one motor with energy, galvanic coupling elements between either an external energy source E or the energy storage means A and the motor M, M.sub.2 for transmitting energy to the motor in contacting fashion, wireless coupling elements adapted to connect either the motor M, M.sub.2 or the energy storage means A or both to an extracorporal primary energy source for transmitting energy to either the motor or the energy storage means or both in non-contacting fashion, control unit C1 for controlling the motor M, M.sub.2, a data transmission interface for wirelessly transmitting data from an external data processing device C.sub.2 to the control unit C.sub.1, the feedback sensor F, wireless energy transforming means, and the injection port 32 for refilling the reservoir R.sub.1.
