Cross Reference: This Application claims priority to and the benefit of provisional application serial number 62/391,588 filed on May 03, 2016 and entitled Mechanical & Vibratory Device In Combination With Inflatable Constriction Device For Treatment Of Erectile Dysfunction and Penile Rehabilitation; and provisional application serial number 62/386,086 filed on November 18, 2015 and entitled Mechanical & Vibratory Devices In

Combination With Inflatable Constriction Device For Treatment Of Erectile Dysfunction and Penile Rehabilitation.

BACKGROUND

[0001] FIELD: This technology as disclosed herein relates generally to medical devices and, more particularly, to medical devices to address erectile dysfunction.

[0002] BACKGROUND: Erectile dysfunction is a medical condition that impacts several men. The medical disorder can be manifested as the inability to obtain and/or sustain an erection. Various stimulus devices have been utilized to induce and erection including vibratory devices and vacuum tube devices. Also various devices have been utilized to sustain and erection including various constriction devices. However, many of the devices available are cumbersome and impractical or don't adequately address the problem, particularly in the more severe cases of the disorder. A more practical and effective medical device is needed to address this common dysfunction.

SUMMARY [0003] The technology as disclosed herein includes an apparatus for constricting blood flow and for providing vibratory stimulus to address erectile dysfunction. One

implementation of the technology for enhancing erectile function, includes a single vibration unit or multiple vibration units. One implementation of the technology includes proximal and distal annular bands configured to annularly surround a penis close to the base of the penis and proximal to the distal glans penis. For one implementation of the technology, the two annular bands are connected by means of single or multiple elongated intermediate bars, which house vibratory units. The intermediate bars are configured to partially cover a penis between the bands during use. One implementation of the device is made of an elastic, skin- compatible, slipper/smooth material.

[0004] One implementation of the technology as disclosed and claimed herein can be utilized in combination with a vacuum based erection inducing device. An erection inducing vacuum inflatable constriction device (VICD) is designed to address erectile dysfunction. The technology can include a vacuum chamber, which has a distal end for connection to a manual or battery powered vacuum generating device. The technology further includes a pliable constriction ring, which can be an inflatable constriction device (ICD) to be positioned at the base of the base of the penis. The vacuum chamber includes length marking for the user to record the progress.

[0005] One implementation of the technology as disclosed and claimed herein can be used in combination with an implanted penile prosthesis device. Placement of an implant is an effective method for treating erectile dysfunction, however, it does interfere with the normal architecture of the corpora cavenosa that may still have an functional erectile tissue, and implants do not extend in the glans of the penis. The cavernosal erectile tissue and glans continue to suffer from underlying hemodynamic dysfunction, that do not engorge fully, therefore, remains soft and cold, giving rise to concord tip deformity in case of glans. This can be addressed by pharmacological/ mechanical means that will make the penis look and feel normal, thermally and otherwise.

[0006] The technology as disclosed and claimed herein, will help to retain an erection in the residual penile tissue and the glans of the penis. The Inflatable Constriction Device (ICD) as disclosed and claimed herein can be utilized in combination with a penile prosthesis device. The technology as disclosed and claimed includes inflatable proximal and distal rings, an inflation pump and tubing system and an intermediate bar carrying micro-channel for providing an air passage for inflation of a distal inflatable ring.

[0007] Another implementation of the technology is its use as an external penile prosthesis, which includes proximal and distal annular bands attached to the proximal and distal inflatable constriction rings configured for encircling an anatomical elongated tubular structure. The rings are configured to be inflatable by air and/or liquid. The annular bands are connected by intermediate single bar or multiple bars. For one implementation of the technology the intermediate bars have a support mechanism in the form of single or multiple stiff bars, which can be flexible or rigid. In yet another implementation the support is provided in the form of external inflatable "splint" mechanism as well. The technology as disclosed is suitable for the patient who is able to have an erection, but cannot maintain it or does not want to use s vibrator or a vacuum inflatable constriction device (VICD).

[0008] The device according to the disclosure herein includes a proximal and distal annular band like structure by means of which the device completely surrounds a preferably tubular and elongate anatomical body at a proximal and a distal end in an annular fashion. An intermediate bar/ bars extends between the two annular bands. The intermediate bar includes a single bar for one implementation, but can include two or more bars for a multiple bar configuration. For one implementation of the technology, a splint is integrated within the device by means of extending longitudinally within the intermediate bar along substantially the entire length of the intermediate bars, thereby providing support along substantially the entire length of penis. The device includes an elastic, skin-compatible and smooth material.

[0009] One implementation of the technology as disclosed and claimed herein includes an external vibratory device. A vibratory device can be utilized to induce an erection by means of vibration forces being applied to the penis of a user, and its nerves (Dorsal Nerve and Perineal Nerve, and Cavernous Nerve) by means of contacting the penis of a user. The device can be used for penile rehabilitation, and can be used by an individual with erectile dysfunction who needs or prefers to use vibration, but does not want to wear the vibratory device during intercourse. These patients can often attain an erection by using vibratory stimulation, but may or may not need additional assistive devices to induce or maintain an erection. This device can be used for ejaculation in paraplegic patients. [0010] One implementation of the technology includes an external vibrator, which includes multiple longitudinal bands of flexible skin compatible material, where the longitudinal bands house vibratory units in a longitudinal fashion and extending substantially along the entire length of penis to directly provide stimulation. The vibratory units are replaceable by extracting the vibratory unit through a slit in the band or inserting a vibratory unit through the slit. The dorsal/ dorsolateral vibratory unit covers the dorsal/dorsolateral area of the penis and stimulates the penile skin and the dorsal nerve, and the ventral vibratory unit covers the urethral area and stimulates penile skin and the perennial nerve. An extension in the ventral area can be provided to stimulate the frenulum. A user can hold the device and press it against the penis to help impart the vibration.

[0011] The features, functions, and advantages that have been discussed can be achieved independently in various implementations or may be combined in yet other implementations further details of which can be seen with reference to the following description and drawings.

[0012] These and other advantageous features of the present technology as disclosed will be in part apparent and in part pointed out herein below. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] For a better understanding of the present technology as disclosed, reference may be made to the accompanying drawings in which:

[0014] Fig. 1 is a side view of the device;

[0015] Fig. 2 is cross section through the proximal annular band ; [0016] Fig. 3 is a cross section through the intermediate bars;

[0017] Fig. 4 is a side view of the device with a single top intermediate bar ; [0018] Fig. 5 is aside view of one implementation of the device showing the inflation mechnism;

[0019] Fig. 6 is atop view of one implementation of the device showing the inflation mechanism and dorsal vibrator;

[0020] Fig. 7 is constriction ring with dorsal and dorsolateral projections;

[0021] Fig. 8 is a constriction ring with a dorsal and dorsolateral cushion;

[0022] Fig. 9 is a constriction ring with a dorsal and urethal projection;

[0023] Fig. 1 1 is a side view of a vacuum chamber stimulation device;

[0024] Fig. 12 is a side view of another implementation of a vacuum chamber stimulation device;

[0025] Fig. 13A is a side view of another implementation of a vacuum chamber stimulation device having two pumps;

[0026] Fig. 13 B shows inflation/ deflation system incorporated at distal end and tubing running along wall of the vacuum chamber;

[0027] Fig. 13 C is inflatable constriction ring;

[0028] Fig. 14 is coaxial constriction ring;

[0029] Fig. 15 is another view of a coaxial constriction ring;

[0030] Fig. 16 is a side view of a vibrator sleeve; and

[0031] Fig. 17 is a sectional view of the vibrator sleeve; and [0032] Fig. 18 is an inflatable splint configuration; and

[0033] Fig. 19 is a configuration of proximal and distal inflatable constriction rings(ICD) with intermediate band housing the microchannel for distal ICR ; and

[0034] Figs 20A, 20B and 20C are various constriction ring implementations.

[0035] While the technology as disclosed is susceptible to various modifications and alternative forms, specific implementations thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description presented herein are not intended to limit the disclosure to the particular implementations as disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present technology as disclosed and as defined by the appended claims.

DESCRIPTION

[0036] According to the implementation(s) of the present technology as disclosed, various views are illustrated in Fig. 1-20 and like reference numerals are being used consistently throughout to refer to like and corresponding parts of the technology for all of the various views and figures of the drawing. Also, please note that the first digit(s) of the reference number for a given item or part of the technology should correspond to the Fig. number in which the item or part is first identified.

[0037] One implementation of the present technology as disclosed comprising an inflatable constrictive band and a vibratory unit teaches a novel apparatus and method for addressing erectile dysfunction. The technology includes a proximal and distal annular band structure configured to surround an elongate anatomical body like a penis at proximal and distal ends in an annular fashion. With one implementation of the technology, an elongated intermediate bar extends between the proximal and distal annular band structures. In another implementation of the technology there can be multiple elongated intermediate bars extending between the proximal and distal annular band structures.

[0038] The intermediate bars have sufficient length such that the proximal annular band can be positioned at the base of a penis proximate a user's abdomen and scrotum; and the distal annular band structure can be positioned proximate the base of the glans of the user. The length of the intermediate bar, or bars, can vary in length depending on the anatomy of the user. A vibration unit, or units (in the case of multiple intermediate bars), are integrated within, or housed within, the device extending longitudinally and substantially along the entire length of the intermediate bars. The vibratory unit positioned within the intermediate bars and extending substantially along the entire length of the intermediary bar allows the device to impart vibration to the almost entire length of penis directly. One implementation of the technology as disclosed includes an elastic, skin-compatible and smooth/ slippery material on the outside.

[0039] The intermediate bar can have extension beyond the distal annular band along the ventral area to stimulate the Frenulum of prepuce of penis (frenulum), which is an elastic band of tissue under the glans penis that connects the foreskin (prepuce) to the vernal mucosa. The device can be worn in a different fashion depending on individual. One implementation of the technology includes stretchable and pliable smaller ring like structures attached to the proximal and distal annular bands to help prevent venous outflow and also help keep the device in position. These ring like structures preferably have non-slippery inner surfaces. [0040] One implementation of the technology as disclosed and claimed includes inflatable constriction rings in lieu of the stretchable smaller rings like structures attached the proximal and distal annular bands as described to control venous outflow and as a secondary benefit, help anchor the device to penis. Venous outflow is a significant factor in causing erectile dysfunction in many middle aged and most elderly patients and in selected patients of a younger age.

[0041] One implementation of the constriction ring includes an inflatable ring like structure having an interior bladder communicable with an inflation system and a pliably expandable wall structure containing the interior bladder and forming a ring like structure. A proximate inflatable annular ring is configured to encircle the base of penis and a distal inflatable ring is configured to encircle the base of Glans.

[0042] One implementation of the outer surface that is opposite of the side that contacts the penis of such inflatable ring is made of non- resilient material and inner surface that contacts the penis is be made of skin compatible preferably non-slippery material. Any material can be used that will allow for inflation to provide constriction. This proximate and distal inflatable ring can be inflated by air or liquid. The inflation system that is

communicable with the interior bladder is configured to push a flow of air or liquid to fill the bladder and expand at least the inner surface of the inflatable ring to thereby reduce its diameter and apply an inward pressure against the penis to constrict blood flow. [0043] One implementation of the inflatable constriction ring includes a manual or battery operated mini-pump having an outlet port through which air or fluid is forceably pumped. The outlet port of the mini-pump, in one implementation, is communicable connected to the interior bladder by a tube. The mini-pumps are attached to the inflatable constriction rings by detachable tubing either directly to the inflatable ring or by means of small tubing attached to the annular band above ring.

[0044] One implementation of the proximal and distal constriction rings includes an ear like structure to assist with placing the ring around the penis and removing the ring from the penis. If the technology is utilized in combination with a vacuum chamber, as will be discussed further, the ends of ear like structure can be placed inside the sealing end of the vacuum chamber to assist with holding the ring in position while applying vacuum to vacuum chamber if so desired.

[0045] One implementation of the proximal and distal inflatable constriction ring includes projections on the inner surface that cover and apply pressure to the dorsal and dorsolateral position of the penis at the base corresponding to the position of the penile veins whereby the ring can have a continuous cushion covering the dorsal and dorsolateral position of the penis to thereby apply a continuous pressure to constrict venous out-flow through the veinsin this area. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patients requiring high pressure in the ring to control a venous leak problem. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein.

[0046] One implementation of the proximal and distal inflatable constriction ring includes projections on the inner surface on dorsolateral and ventrolateral positions to compress the corpora cavernosa diagonally to impede venous outflow form corpora cavernosa. One implementation of the proximal and distal inflatable constriction ring includes projections different shapes on the inner surface on lateral positions to compress the corpora cavernosa from sides to impede venous outflow form corpora cavernosa

[0047] With one implementation the proximal and distal inflatable rings have a groove at the position corresponding to area of urethra. The groove can be used in combination with the projections and/or cushions. However, the distal inflatable ring may only include a groove for urethra. The grooves are kept in place when inflation occurs by reinforcing ventral ends constructed with a stiffening material/mechanism. The end of the ring in the urethral area of penis are reinforced with stifling material and a stiff bar member bridges the gap between the two stiff non-contacting ends of the ring. Two attachments obliquely attached between the end of ring and stiff bar further anchor the ends of ring to the bar to prevent ends of the ring to push inwards dorsally. The groove allows the free passage of ejaculate, however, the groove may allow venous outflow from the Corpus Spongiosum causing loss of erection particularly of glans penis. [0048] For one implementation, to address above problem, the urethral groove can be eliminated and replaced with a bulge or cushion at the Comus Spongiosum position. With this implementation deflation of the inflatable ring is effected by manually operating or controlling remotely the inflation system to facilitate the natural ejaculation. Similarly this implementation can be utilized for both the proximal and distal constriction rings. The tubing of inflation system is connected to outer surface of inflatable constriction ring. The tubing of the inflation system connected to the distal constriction ring is attached by means of micro-channel running through the intermediate bar acting as a fluid communication conduit between the tubing and the interior bladder of the inflatable constriction ring.

[0049] The tubing attaching the inflatable mini-pumps have a detachment mechanism close to the proximal inflatable constriction ring, and the part of the tubing that remains attached to the inflatable constriction ring also has a deflation release valve that can be used to deflate the inflatable constriction ring after use. One implementation of the tubing is directly attached to the inflatable ring in case of the proximal inflatable constriction ring and the constriction ring itself has a pressure release valve. The constriction ring is also deflatable by connecting the detached tubing and using the release valve of mini-pump.

[0050] After inflating the inflatable constriction rings optimally, the tubing is detached and the part of the tubing attached to constriction ring- stumps- is stored in a small pocket attached to ring to prevent injury from a loose end during intimate contact. The tubing of the inflation system for the inflatable constriction ring also has pressure measuring gauge to measure the pressure in the inflatable constriction ring. The proximal constriction ring, especially with cushion at the Corpus Spongiosum position, may be enough to maintain erection of the Copora Cavernosa and Corpus Spongiosum/ Glans Penis; therefore, distal inflatable constriction ring mechanism may not be necessary. [0051] The proximal annular band of the device is arranged at the base of the penis and the distal annular band is arranged proximal to glans of the penis. The device can also be placed on the penis in a different fashion; however, the Frenulum extension has to be worn in certain way so that the extension maintains contact with the Frenulum. A significant advantage of the invention is that the vibration unit/ units are completely housed in the device extending almost entire length of the device and so that the device imparts vibration directly to penis and penile nerves along almost the entire length of penis. However, single or multiple vibratory units are inserted at the base of penis or frenulum region over a short duration for people with a mild erectile problem with or without stiffened intermediate bars. [0052] One implementation of the technology includes a battery for powering the vibratory unit and the battery can be integral with the vibratory unit. The vibration unit can be switched on and off and the intensity or amplitude of the vibration force can be selectively and variably adjusted remotely with a control unit by transmitting a signal from the control unit to the vibration unit via a communication wire or by way of wireless connectivity. The battery or other power source can also be remotely connected to the vibrating unit by means of a cable. With one implementation, the vibratory unit can include a battery container that also contains a control that control the unit to switch on and off and adjust the intensity. In one implementation the battery/ power source with control mechanism is placed in the wireless remote control unit.

[0053] Various implementation of the vibration unit includes one or more of a piezo electric vibrator, an eccentric rotating mass vibrator, a linear resonant actuator vibrator or any other appropriated type of vibrator. One implementation of a vibration unit is easily replaced, which includes an opening in the annular band that opens to an interior channel of the intermediate bar into which a vibratory unit is installed and through which a vibratory unit is removed. The vibration unit can be removed through the opening that can be covered with water tight cover. Alternatively Vibratory unit can be placed permanently in the intermediate bar especially in case of remote power source or with a long life power source.

[0054] One implantation of the technology includes a stretchable beaded ring attached on the proximal annular band of the device. The stretchable beaded is configured to be extended about the testicle area (scrotum) to thereby further secure the device. A small tightening ring is threaded over the beaded rind to tighten or loosen the beaded ring about the scrotum. This arrangement provides additional support for the main device and also imparts vibration to the scrotum. The device can be held against the flaccid penis by collapsing the flexible device with hand and urging the vibrators in contact with the penile skin causing stimulation of one or more than one penile surface and associated nerve ending of dorsal nerve/ perineal nerve that can assist with attaining an erection. The patient can continue to wear the device throughout intercourse.

[0055] As result of the stiffness imparted by the vibratory units in the longitudinal direction encased in flexible skin compatible material coupled with the effect of vibration to enhance penile blood flow to help achieve erection, the device can provide erection for successful intercourse in individual with erectile dysfunction. [0056] If the erectile function is compromised to a point that vibrations imparted to the penis cannot give the desirable results, the device can be used in combination with a Vacuum Inflatable Constriction Device (VICD) designed for achieving and maintaining erection, which is separately described herein. The device can also be used alone or in combination with other devices. An added advantage of the device is that it increases circumference of the penis over the almost entire length of the penis.

[0057] The details of the technology as disclosed and various implementations can be better understood by referring to the figures of the drawing. Referring to Fig. 1 , a side view of the device is shown. The technology as shown in Fig. 1 includes, a proximal annular band 105 and a distal annular band 104. Intermediate bars 102 extend between and connect the proximate and distal annular bands. The intermediate bars housing vibratory units 103 and the vibratory units extend longitudinally substantially along the entire length of the intermediate bar. Therefore, the vibratory unit 103 will extend longitudinally substantially along the entire length of the penis. In other implementations, three or even four intermediate bars can extend between the annular bands, each housing vibratory units. The device is configured such that it can be installed to position the distal annular band to encircle the penis proximate to the glans 113. The device is also configured such that it can be installed to position the proximate annular band to encircle the base area 114 of the penis proximate to the abdomen and scrotum area of the user. The distal inflatable constrictive ring 106 is sized and configured to encircle the penis at the base of glans 117. The proximal inflatable constrictive ring 107 is configured to encircle the penis close to base of penis 114. [0058] A slit (or opening) 108 is included in the proximate annular band, which opens to an elongated interior channel of an intermediate bar such that a vibratory unit is inserted through the opening and into the elongated interior channel such that the vibrator unit is housed in the elongated intermediate bar and extends longitudinally along substantially the entire length of the elongates intermediate bar. The slit (or opening) 108 is configured for insertion through and placement of the vibratory unit with cable 109 passing through the opening for communication with and power to the vibratory unit 103. An external remote control system 1 10 can be utilized and can be configured to house and accommodate a battery or other power sour for the vibratory unit along with a controller. The cable 209 is configured for power and communication transmission. The battery and the control function can be built into the same unitl 10. A stretchable beaded ring 111 is attached on the proximal annular band 105 of the device. The stretchable beaded ring 111 is configured to be extended about the testicle area (scrotum) to thereby further secure the device. A small tightening ring 112 is threaded over the beaded rind to tighten or loosen the beaded ring about the scrotum. This arrangement provides additional support for the main device and also imparts vibration to the scrotum. The patient can continue to wear the device throughout intercourse. The glans penis 113 and portions of the penis 116 are exposed. The Frenulum extension 115 is also illustrated. The intermediate bar 102 can have an extension 115 beyond the distal annular band 104 along the ventral area to stimulate the Frenulum of prepuce of penis (frenulum), which is an elastic band of tissue under the glans penis that connects the foreskin (prepuce) to the vernal mucosa. The device can be worn in a different fashion depending on individual. The upper elongated intermediate bar as shown in Fig. 1, in one implementation, is configured to extend along the dorsal area of the penis and the opposing lower elongated intermediate bar as shown can extend along the ventral area of the penis.

[0059] Referring to Fig. 2, a cross section through the proximal annular band 105 is provided. The interior channel 201 of the intermediate bar 102 that extends from the opening 108 and that contains the inserted vibratory unit 103 is illustrated. One implementation of the technology can include two vibratory units positioned at the dorsal and/or dorsolateral position. Vibratory units positioned in the dorsal and/or dorsolateral positions will stimulate the Dorsal nerves branches along these areas of the penis. The annular band is configured to encircle the base of the penis when being utilized. Referring to Fig. 3, a cross section through the intermediate bars 102 proximate to the distal annular band 104 is illustrated. Again, the interior channel 301 of the intermediate bar 102 that contains the inserted vibratory unit 103 is illustrated. The outline of the distal annular band 104 is also seen. Note that with the implementation as shown, with the device is being utilized by a user, the side portions of the penis are exposed with the intermediate bars 102 extending over the top and bottom areas of the.

[0060] Referring to Fig. 4, a side view of the device with a single top intermediate bar 402 is illustrated, which houses a vibratory system 403. The intermediate bar 402 extends between and connects the proximate annular band 405 and the distal annular band 404. The technology as shown in Fig. 4 includes, a proximal annular band 405 and a distal annular band 404. The intermediate bars house vibratory unit 403 and the vibratory unit 403 extends longitudinally substantially along the entire length of the intermediate bar 402. Therefore, the vibratory unit 403 will extend longitudinally substantially along the entire length of the penis. In other implementations, three or even four intermediate bars can extend between the annular bands, each housing vibratory units. The device is configured such that it can be installed to position the distal annular band 404 to encircle the penis proximate to the glans. The device is also configured such that it can be installed to position the proximate annular band to encircle the base area of the penis proximate to the abdomen and scrotum area of the user. The distal inflatable constrictive ring 406 is sized and configured to encircle the penis at the base of glans. The proximal inflatable constrictive ring 407 is configured to encircle the penis close to base of penis.

[0061] A slit (or opening) 408 is included in the proximate annular band 405, which opens to an elongated interior channel of an intermediate bar 402 such that a vibratory unit

403 is inserted through the opening and into the elongated interior channel. The slit (or opening) 408 is configured for insertion through and placement of the vibratory unit with cable passing through the opening for communication with and providing power to the vibratory unit 403. An external remote control system can be utilized and can be configured to house and accommodate a battery or other power sour for the vibratory unit along with a controller. A cable can be configured for power and communication transmission. The battery and the control function can be built into the same unit. A stretchable beaded ring 411 is attached on the proximal annular band 405 of the device. The stretchable beaded ring 411 is configured to be extended about the testicle area (scrotum) to thereby further secure the device. A small tightening ring 412 is threaded over the beaded rind to tighten or loosen the beaded ring about the scrotum. This arrangement provides additional support for the main device and also imparts vibration to the scrotum. The patient can continue to wear the device throughout intercourse. The device can be worn in a different fashion depending on the individual. This can be worn in different fashion with rearrangement or elimination of scrotal ring. The dorsal vibratory unit can large enough to cover both dorsal nerves or alternatively two separate units can be placed dorsally/ dorsolaterally.

[0062] Referring to Figs. 5 and 6, side and top view of one implementation of the device is illustrated with dual vibratory units. Fig. 5 predominantly illustrates an inflation system for the proximal 507 and distal 506 inflatable constrictive rings. A pocket 517 for storage of parts of inflation tubing is provided so that loose tubing is stowed to avoid discomfort. A micro-channel 518 is illustrated that extends through the intermediate bar 502 that is used as a fluid passageway to transmit air or other fluid to inflate the distal constriction ring 506. [0063] One implementation of the technology includes an inflation system 519 for the distal constriction ring 506. The inflation tubing part is separated into two parts 530 and 531. Parts 530 and 531 are detached after attaining optimum pressure in the constriction rings and 530 from both tubes is placed in the pocket 517. There is a mechanism for deflating the constriction rings by using a release valve located on 531 or on the inflatable ring. Deflation of inflatable constriction ring can also be achieved by connecting 531 tubing and using the deflation knob 522. One implementation of the technology can include a pressure measuring gauge 521. One implementation can include a deflation knob 522 to adjust the pressure. A manual inflation pump 523 is illustrated. There is also an inflation system 524 for the proximal constriction ring 507.

[0064] Referring to Fig 6, top view is illustrated with one implementation of the device with vibratory unit 603. The elongated vibratory unit 603 extends along a dorsal position. However, one implementation of the technology can include dual vibratory units positioned at the dorsal and/or dorsolateral position, not shown. Vibratory units positioned in the dorsal and/or dorsolateral positions will stimulate the nerves along these areas of the penis. A micro-channel 508 is illustrated that extends through the intermediate bar 502 that is used as a fluid passageway to transmit air or other fluid to inflate the distal constriction ring 506.

[0065] One implementation of the technology includes an inflation system 519 for the distal constriction ring 506. The inflation tubing part is separated into two parts 530 and

531. Parts 530 and 531 are detached after attaining optimum pressure in the constriction rings and 530 from both tubes is placed in the pocket 517. There is a mechanism for deflating the constriction rings by using a release valve located on 530 or on the inflatable ring. Deflation of inflatable constriction ring can also be achieved by connecting 531 tubing and using the deflation knob 522. One implementation of the technology can include a pressure measuring gauge 521. One implementation can include a deflation knob 522 to adjust the pressure. A manual inflation pump 523 is illustrated. There is also an inflation system 524 for the proximal constriction ring 507. The mechanical inflation/deflation system in one implementation is a motorized inflation/deflation system.

[0066] Referring to Fig. 7, one implementation of the constriction ring includes an inflatable ring like structure having an interior bladder communicable with an inflation system and a pliably expandable wall structure containing the interior bladder and forming a ring like structure. A proximate inflatable annular ring is configured to encircle the base of penis and a distal inflatable ring is configured to encircle the base of Glans. [0067] One implementation of the outer surface 710 that is opposite of the side 712 that contacts the penis of such inflatable ring is made of non- resilient material and inner surface that contacts the penis is be made of skin compatible preferably non-slippery material. Any material can be used that will allow for inflation to provide constriction. This proximate and distal inflatable ring can be inflated by air or liquid. The inflation system that is

communicable with the interior bladder is configured to push a flow of air or liquid to fill the bladder and expand at least the inner surface of the inflatable ring to thereby reduce its diameter and apply an inward pressure against the penis to constrict blood flow.

[0068] One implementation of the inflatable constriction ring includes a manual or battery operated mini-pump having an outlet port through which air or fluid is forceably pumped. The outlet port of the mini-pump, in one implementation, is communicable connected to the interior bladder by a tube, where the tube communicably attached to a port 706, which is communicable with the interior bladder. The mini-pumps are attached to the inflatable constriction rings by detachable tubing either directly to the inflatable ring or by means of small tubing attached to the annular band above ring, which has a conduit communicable with the port 706. [0069] One implementation of the proximal and distal constriction rings includes an ear like structure 707 to assist with placing the ring around the penis and removing the ring from the penis. If the technology is utilized in combination with a vacuum chamber, as will be discussed further, the ends of ear like structure can be placed inside the sealing end of the vacuum chamber to assist with holding the ring in position while applying vacuum to vacuum chamber if so desired.

[0070] One implementation of the proximal and distal inflatable constriction ring includes projections 701 on the inner surface that cover and apply pressure to the dorsal and dorsolateral position of the penis at the base corresponding to the position of the penile veins. One implementation, as reflected in Fig. 8 has a continuous cushion 801 covering the dorsal and dorsolateral position of the penis to thereby apply a continuous pressure to constrict blood flow through the blood carrying vessels in these areas. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patients requiring high pressure in the ring to control a venous leak problem. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein. The projection may be eliminated in case of distal constriction ring. One implementation of proximal inflatable constriction ring includes shown in Fig. 20A, dorsolateral 2002 and ventrolateral 2003 projections to compress the root of penis diagonally to impede venous outflow from corpora cavernosa. One implementation of proximal inflatable constriction ring includes shown in Fig. 20 C, shows lateral projections 2004 to compress the root of penis to from sides impede venous outflow from corpora cavernosa. Fig. 20D provides different shape of lateral projection.

[0071] With one implementation the proximal and distal inflatable rings have a groove at the position corresponding to area of urethra - See Fig. 7. The groove can be used in combination with the proj ections and/or cushions. However, with one implementation, the distal inflatable ring may only include a groove for urethra. The grooves are kept in place when inflation occurs by the reinforced ventral ends 702 constructed with a stiffening material/mechanism. The stiffening material can cover the entire outer surface of the ventral ends or the stiffening material may only cover a portion of the outer surface of the ventral end. The ends of the ring in the urethral area of penis are reinforced with a stifling material and a stiff bar member 703 bridges the gap between the two stiffened non-contacting ends of the ring. An attachment 704 on each ventral end is obliquely attached between the end of ring and stiff bar member in order to further anchor the ends of ring to the bar to prevent the ventral ends of the ring from pushing inwards dorsally. The groove allows the free passage of ejaculate, however, the groove may allow venous outflow from the Corpus Spongiosum causing loss of erection particularly of glans penis. In one implementation as shown in Fig. 8, the ring has an open end in the urethral area such that the inflatable constriction ring as shown in Fig. 8 is not a closed ring.

[0072] For one implementation, to address the problem with the groove allowing venous outflow, the urethral groove can be eliminated and replaced with a bulge or cushion 902 at the Corpus Spongiosum position as shown in Fig. 9. With this implementation deflation of the inflatable ring is effected by manually operating or controlling remotely the inflation system to facilitate the natural ejaculation. Similarly this implementation can be utilized for both the proximal and distal constriction rings. The tubing of the inflation system is connected to outer surface of inflatable constriction ring. The tubing of the inflation system connected to the distal constriction ring is attached by means of micro-channel running through the intermediate bar acting as a fluid communication conduit between the tubing and the interior bladder of the inflatable constriction ring.

[0073] One implementation of the technology as disclosed herein is to use an inflatable constriction ring in combination with a vacuum chamber stimulation device. For this implementation, a removable sealing element is placed on the proximal end of the vacuum chamber and is formed of a skin compatible material. The opening of sealing element can vary in diameter to accommodate the different penis size at the base. One implementation includes a concentric inner seal placed inside a larger seal having an opening with a diameter slight less than the outer diameter of the concentric inner seal to thereby create a press fit. One purpose for this implementation is to minimize the suction and potential injury to the tissue surrounding the penis base. During operation the seal is secured on the proximal end of the vacuum chamber. The operator's penis is introduced through the seal's central opening, and the seal is placed against the user's body firmly, and a vacuum is produced by the vacuum generating system to the vacuum chamber. This arrangement has a release valve system to release vacuum after inflating constriction ring, which will be discussed further herein. A pressure measurement gauge is installed for both Vacuum Erection Device and Inflatable Constriction Device.

[0074] The vacuum chamber has opening in its wall at the proximal end close to edge that contacts the user's body to accommodate an air-tight tubing system. Another implementation is such that the opening in the vacuum chambers wall can be abutting adjacent the seal at the proximal end to accommodate air-tight tubing system, which can be slid into this opening or similar arrangement can be made on the side of the sealing device. · [0075] The inflatable constriction ring, with one implementation can be utilized in combination with a vacuum chamber stimulation device that includes an inflation mechanism and an inflatable annular ring encircling the base of penis. The outer surface of such ring can be made of non- resilient material and inner surface can be made of skin compatible non- slippery material. Any material can be used that will provide the inflation constriction mechanism. This ring can be inflated by air or liquid. The other component of the inflatable constriction ring mechanism is a manual or battery operated mini- pump, which can be separate from vacuum generation pump. The mini-pump is attached to the inflatable constriction ring by detachable tubing either directly to the inflatable ring or by means of small tubing attached to above ring. The constriction rings have ear like structures to help put on and off the ring to penis. Ends of ear like structure can be placed inside the sealing end of the vacuum chamber to help it keep the inflatable ring in position while applying vacuum to vacuum chamber.

[0076] The inflatable constriction ring has projections on the inner surface that cover the dorsal and dorsolateral position of the penis at the base corresponding to penile veins. With one implementation, a ring can have on continuous cushion covering the dorsal and dorsolateral position of the penis. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patient requiring high pressure in the ring to control venous leak, in this situation just one dorsal cushion may be more beneficial to compress the dorsal vein. The ring has a groove at the position corresponding to urethra in addition to above projections/ cushions. One implementation of the proximal inflatable constriction ring includes dorsolateral and ventrolateral projections to compress the root of the penis diagonally to impede venous outflow from corpora cavernosa. One implementation of proximal inflatable constriction ring includes lateral projections to compress the root of penis from sides to impede venous outflow from the corpora cavernosa. [0077] The grooves are kept in place by reinforcing ventral ends with stiffening material/mechanism. The ends of the ring towards the urethral area of penis are reinforced with stiffening material and a stiff bar that bridges the gap between the two stiff ends. The grooves are kept in place by reinforcing ventral ends with stiffening a material/mechanism. The ends of the ring towards the urethral area of penis are reinforced with a stiffing material and a stiffening bar that bridges the gap between the two stiff ends. Two attachments are attached obliquely between the end of ring and the stiffening bar in order to further anchor the ends of ring to the bar to prevent the ends of the ring from pushing inwards dorsally. The groove allows the free passage of ejaculate, however, groove may allow venous outflow from the Corpus Spongiosum causing loss of erection particularly of the glans penis. The urethral groove can be eliminated and replaced with bulge or cushion at the Corpus Spongiosum/ urethral position. The deflation of a ring occurs by manual or remote control mechanism to facilitate the natural ejaculation. The tubing of inflation system is connected to outer surface of the proximal inflatable constriction ring. [0078] The tubing attaching the inflatable mini-pumps have detachment mechanism close to the proximal constriction ring and part of the tubing that remain attached to ring also has deflation release valve that can be used to deflate the constriction after use. Alternatively detachable tubing can be directly attached to the inflatable ring and constriction ring itself can have pressure release valve. The constriction ring can also be deflated by connecting the detached tubing and using the release valve of mini-pump. The constriction ring especially with cushion at the Corpus Spongiosum position may be enough to maintain erection of Copora Cavernosa and Corpus Spongiosum/ Glans Penis and distal ring may not be required as described in other sections. [0079] The mini-pump for inflation of inflatable constriction ring can also be incorporated in the main vacuum pump located at distal end of vacuum chamber along with pressure gauge. The tubing to the VICD can travel along inside or outside of vacuum chamber and connect to inflatable ring through the opening of proximal seal / air-tight mechanism as described above in case of having tube placed outside of the vacuum chamber wall. The tubing from inflation/deflation mechanism can be either in form of double tubing or dual channel tubing. The pressure release valves are provided for both vacuum chamber and constriction ring to adjust the optimum pressure to attain desired results. So, the distal end of the vacuum chamber has suction pump, suction release valve & pressure gauge for suction chamber and inflation pump, pressure release valve & pressure gauge for ICD.

[0080] As discussed herein for other implementations, the advantage of inflatable constriction device is that the pressure can be adjusted in the constriction ring. The pressure can be high enough to occlude venous and arterial flow completely if so desired. Pressure can be adjusted to allow entry of some arterial flow and allow some venous return to mimic natural erection. This can also alleviate the problem of penis changing color and penis feeling cold as happens with latex/ rubber constriction devices. The blood that fills the penis using the current vacuum constriction devices (VCD's) is of mixed type i.e. both arterial and regurgitating venous blood.

[0081] It is possible to inflate the constriction ring device partially to block regurgitation venous blood and apply the vacuum pressure slowly and fill the corpora cavernosa with arterial blood. This can be of value in particular for penile rehabilitation following radical prostatectomy and pelvic surgery etc. as this technique would provide more oxygenated blood to the penile tissue. The same technique can be used to also increase constriction ring application time often quoted to be 30 minute time. Patients with varying degree of erectile dysfunction can adjust the pressure of a Inflatable Constriction Device (ICD) that will give them the optimal erection with natural results and can be used in combination with other erection enhancing devices like vibratory system or external prosthesis. Other complications associated with current VCD's including pain, bruising etc. can be reduced if not eliminated by using VICD, thus increasing the compliance. The inflatable constriction can be as standalone mechanism for a patient who can get erection on their own but have difficulty maintaining the erection.

[0082] Referring to Fig. 1 1, a vacuum chamber stimulation device 11 14 is shown. The implementation of the vacuum chamber stimulation device as shown includes a vacuum chamber 1102 and an inflation system. One implementation of the apparatus as disclosed herein and as shown in Fig. 11 is a tubular vacuum chamber stimulation device. A vacuum pump 1103 is attached at the distal end of the vacuum chamber 1102. The vacuum pump 1103, can include a power button 1116 that initiates the application of a vacuum in the vacuum chamber. The vacuum pump can also include a release valve 1118 that initiates the release of the vacuum within the chamber. The vacuum pump can be manual or it can be powered by a motorize pump. The vacuum chamber stimulation device also includes a seal 1104 at the proximal end of the vacuum chamber. The seal can be pressed against the users abdomen are at the base of the penis in order to form a seal. The seal 1104 has a central opening to accommodate the insertion of the user's penis into the vacuum chamber. The side wall of the vacuum chamber includes an air-tight access portal 1105, through which the tube 1106 of the inflation systeml 120 is inserted in order to attach to the inflatable constriction ring. The air-tight access portal 1105 is shown located close to edge of proximal end of the vacuum chamber. Referring to Fig. 12, the implementation of the vacuum chamber stimulation device 1214 is practically the same as the implementation illustrated in Fig. 11, except that the air-tight access portal 1205 for the inflation system 1220 is located at the edge of the vacuum chamber proximate the seal 1204. The air-tight part of inflation system can be removed and replaced by sliding it at the edge of vacuum chamber after securing the constriction ring at the base of penis and after connection the tubing. This arrangement may be more convenient for some users.

[0083] Referring to Fig. 13, a dual inflation system is shown where both a proximate inflatable constriction ring and a distal inflatable constriction ring is utilized in combination with a vacuum chamber stimulation device. The implementation of the vacuum chamber stimulation device as shown includes a vacuum chamber 1302 and inflation systems 1308 and 1309. A vacuum pump 1303 is attached at the distal end of the vacuum chamber 1302. The vacuum pump 1303, can include a power button 1316 that initiates the application of a vacuum in the vacuum chamber. The vacuum pump can also include a release valve 1318 that initiates the release of the vacuum within the chamber. The vacuum pump can be manual or it can be powered by a motorize pump. The vacuum chamber stimulation device also includes a seal 1304 at the proximal end of the vacuum chamber. The seal can be pressed against the users abdomen are at the base of the penis in order to form a seal. The seal 1304 has a central opening to accommodate the insertion of the user's penis into the vacuum chamber. The side wall of the vacuum chamber includes an air-tight access portal 1305, through which the tubes 1306 and 1311 of the inflation systems 1308 and 1309 are inserted in order to attach to the inflatable constriction ring. The air-tight access portal 1305 is shown located close to edge of proximal end of the vacuum chamber. Referring to Fig. 13A, the implementation of the vacuum chamber stimulation device 1314 is practically the same as the implementation illustrated in Fig. 1 1, except that the air-tight access portal 1305 for the inflation systems includes inflation systems for both a proximal and distal inflatable constriction ring. Fig. 13 B shows other implementation where the suction pump 1323 and release pump 1322 for vacuum chamber 1320 and the inflation pump 1325 and deflation pump 1324 for the proximal ring pop valve 1326 that opens with excessive negative pressure in the vacuum chamber, and pressure gauges 1327 for pumps that are located at the distal end of the vacuum chamber. The tubing 1321 connecting the inflation/deflation pump at the distal end of the vacuum chamber with the proximal ring at the base of the penis runs along the wall of vacuum chamber. Fig. 13 C shows the proximal ring 1331 with the receiving port 1328 for the inflation/deflation tubing as mentioned above and independent port/knob to deflate the ring after use, the port/knob 1329 may be manually or remotely controlled. The proximal end 1330 of the tubing 1321 connects with the receiving port 1328 of the ring. Fig. 13B and 13 C are appropriately labelled. As is seen in Figs. 14 and 15, the outer diameter of the proximal constriction ring is less than the tubular vacuum chamber inner diameter such that there is no sealing relationship between the pliable ring and the tubular vacuum chamber.

[0084] Figs. 14 and 15 illustrate the position of the inflatable constriction ring in relation to the seal at the base of the vacuum chamber. The inflatable constriction ring 1402 does not form an air tight sealable relationship with the interior surface 1502 of the seal 1404. Also, the implementation as disclosed in Figs. 14 and 15, has the inflation tube 1406 extending through a conduit 1408 and through the seal 1404 in order to communicably connect to the inflatable constriction ring 1402.

[0085] One implementation of the technology 1901 as shown in Fig. 19 is the technology in combination with an implanted penile prosthesis, where a constriction ring (ICD) is applied at the base of the penis. One implementation includes a proximal inflatable constriction ring 1905 that is attached to the inflation system 1910. The constriction ring includes an inflatable ring like structure having an interior bladder communicable with an inflation system and a pliably expandable wall structure containing the interior bladder and forming a ring like structure. A proximate inflatable annular ring is configured to encircle the base of penis and a distal inflatable ring is configured to encircle the base of Glans. The proximal 1905 and distal 1904 ring are attached by means of intermediate bar 1902 that houses the microchannel 1903 contacting the distal inflatable ring 1904 to the inflation deflation mechanism 1909.

[0086] One implementation of the outer surface that is opposite of the side that contacts the penis 1911 of such inflatable ring is made of non- resilient material and inner surface that contacts the penis is be made of skin compatible preferably non-slippery material. Any material can be used that will allow for inflation to provide constriction. This proximate and distal inflatable ring can be inflated by air or liquid. The inflation system that is

communicable with the interior bladder is configured to push a flow of air or liquid to fill the bladder and expand at least the inner surface of the inflatable ring to thereby reduce its diameter and apply an inward pressure against the penis to constrict blood flow. [0087] One implementation of the inflatable constriction ring includes a manual or battery operated mini-pump having an outlet port through which air or fluid is forceably pumped. The outlet port of the mini-pump, in one implementation, is communicable connected to the interior bladder by a tube 1907. The mini-pumps are attached to the inflatable constriction rings by detachable tubing 1907 either directly to the inflatable ring or by means of small tubing attached to the annular band above ring.

[0088] One implementation of the proximal and distal constriction rings includes an ear like structure to assist with placing the ring around the penis and removing the ring from the penis. If the technology is utilized in combination with a vacuum chamber, as will be discussed further, the ends of ear like structure can be placed inside the sealing end of the vacuum chamber to assist with holding the ring in position while applying vacuum to vacuum chamber if so desired. [0089] One implementation of the technology is where a constriction ring is applied at the base of the penis, that is attached to the inflation system 1910. The constriction ring includes an inflatable ring like structure having an interior bladder communicable with an inflation system and a pliably expandable wall structure containing the interior bladder and forming a ring like structure. A proximate inflatable annular ring is configured to encircle the base of penis. With one implementation a distal inflatable ring is configured to encircle the base of Glans 1912. The inflation system 1909 can be communicably connected to the distal inflatable constriction ring by way of the micro channel 1903housed in the intermediate band 1902.

[0090] The proximal inflatable constriction ring has projections on the inner surface that cover the dorsal and dorsolateral position of the penis at the base corresponding to penile veins. With another implementation the ring can have on continuous cushion covering the dorsal and dorsolateral position of the penis to impede venous leak from penile veins. The cushion at dorsolateral position may impede arterial flow also in dorsal arteries in a patient requiring high pressure in the ring to control venous leak. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein. One implementation of proximal inflatable constriction ring includes dorsolateral and ventrolateral projections to compress the root of penis diagonally to impede venous outflow from corpora cavernosa. One implementation of proximal inflatable constriction ring includes shows lateral projections to compress the root of penis to from sides to impede venous outflow from corpora cavernosa. [0091] The proximal ring has a groove at the position corresponding to urethra in addition to above projections/ cushions, however, the distal inflatable ring has only groove for urethra. The grooves are kept in place by reinforcing ventral ends with stiffening material/mechanism. The ends of the ring towards the urethral area of penis are reinforced with stiffing material and a stiff bar that bridges the gap between the two stiff ends. Two attachments are attached obliquely between the end of ring and stiff bar in order to further anchor the ends of ring to the bar to prevent the ends of the ring from pushing inwards dorsally. [0092] The groove allows the free passage of ejaculate, however, a groove may allow venous outflow from the Corpus Spongiosum causing loss of erection of the glans penis. As presented herein, to address this problem of venous outflow, the urethral groove can be eliminated and replaced with a bulge or a cushion at the Corpus Spongiosum position. An implementation for deflation of ring is made by a manual or a remote control mechanism to facilitate the natural ejaculation. A similar arrangement can be made for a distal constriction ring. The tubing of inflation system is connected to the outer surface of proximal inflatable constriction ring. The tubing of the inflation system is connected to the distal constriction ring by means of micro-channel running through the intermediate band/bar connecting the proximal and distal rings. The tubing attaching the inflatable mini-pumps to the distal ring has an attachment port close to the proximal constriction ring.

[0093] The distal ring arrangement is similar except that the ring is attached to the inflation mechanism by a micro-channel that travels through the intermediate band/bar connecting the proximal and distal ring does not require projections. The urethral groove may be replaced with cushion to impede the venous flow from the Glans with manual or remote control release mechanism to deflate the ring to facilitate natural ejaculation. [0094] The configuration as described may be good with solid malleable implants, but inflatable implants may not tolerate high pressure at the base of penis. The proximal ring for the base of the penis may be designed without dorsal/ dorsolateral cushions and pressure may be kept low. This distal ring proximal to Glans will mainly provide engorgement of Glans in this situation. This arrangement combined with the VICD as described will help attain erection of residual erectile tissue of Corpora Cavernosa and Corpus Spongiosum/ Glans.

[0095] One implementation of the present technology includes an inflatable splint 1801. Referring to Fig. 18 an inflatable splint 1801 is shown. One implementation of the splint structure is an inflatable splint structure including exterior walls enclosing an interior inflatable bladder. The splinting of the penis is achieved by an inflatable structure with its own inflation system 1827. The outer surface can be made of non- resilient material and inner surface can be made of skin compatible non-slippery material. Any material can be used that will provide the inflation /stiffness. The whole system, excluding the Inflatable constriction rings 1806 and 1807, is one cavity or internal bladder that can be inflated by inflation mechanism 1827, which is like the inflation mechanisms 1823 and 1834 utilized for the inflatable constriction ring. The inflation tubing 1820 is attached to the proximal annular band 1805. All the system is covered by skin compatible slippery/ smooth material.

[0096] Multiple elongated inflatable splints extending in parallel longitudinally can be utilized. Annular bands 1804 and 1805 can be attached at the proximal and distal ends of the inflatable splints. One implementation of the technology includes stretchable smaller constriction rings like structures attached to above mentioned proximal and distal annular bands to help prevent venous outflow and help keep the device in position. These structures have non-slippery inner surface. Another implementation of the technology as described has, in lieu of the stretchable smaller rings like structures attached to above mentioned proximal and distal annular bands as described, inflatable constricting rings to control venous outflow and help anchor the device to penis as a secondary benefit. As discussed the venous outflow is significant factor in in causing erectile dysfunction in many middle aged and most elderly patients and in selected patients at younger age. The inflatable longitudinally running inflatable splints may be replaced with a solid intermediate splint structure, a rigid intermediate splint structure, a pliable intermediate splint structure or a flexible splint structure.

[0097] Similar to other implementations, the constriction ring includes an inflation mechanism; an inflatable annular ring encircling the base of penis and an inflatable ring encircling the base of Glans. The outer surface of such ring can be made of non- resilient material and inner surface can be made of skin compatible preferably non-slippery material. Any material can be used that will provide the inflation constriction mechanism. This ring can be inflated by air or liquid. The inflatable constriction ring mechanism includes a manual or a battery powered mini-pump. [0098] Similar to other implementations, the mini-pumps are attached to the inflatable constriction rings by detachable tubing either directly to the inflatable ring or by means of small tubing attached to above ring. The proximal inflatable constriction ring has projections on the inner surface that cover the dorsal and dorsolateral position of the penis at the base corresponding to penile veins. Similar to other implementations, one implementation of the ring has a continuous cushion covering the dorsal and dorsolateral position of the penis. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patient requiring high pressure in the ring to control venous leak. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein. One implementation of proximal inflatable constriction ring includes dorsolateral and ventrolateral projections to compress the root of penis diagonally to impede venous outflow from corpora cavernosa. One implementation of proximal inflatable constriction ring includes shows lateral projections to compress the root of penis to from sides to impede venous outflow from corpora cavernosa

[0099] In one implementation the proximal ring has a groove at the position corresponding to urethra in addition to above projections/ cushions, however, the distal inflatable ring has only groove for urethra. The grooves are kept in place by reinforcing ventral ends with stiffening material/mechanism. The end of the ring towards urethral area of penis are reinforced with stiffing material and stiff bar that bridges the gap between the two stiff ends. Two attachments are attached that are oblique between the end of ring and stiff bar further anchor the ends of ring to the bar to prevent ends of the ring to push inwards dorsally. The groove allows the free passage of ejaculate, however, groove may allow venous outflow from the Corous Spongiosum causing loss of erection, particularly for the glans penis. To address above problem the urethral groove can be eliminated and replaced with bulge or cushion at the Corous Spongiosum position. Arrangement for deflation of ring can made by manual or remote control mechanism to facilitate the natural ejaculation by having deflation port/knob on the ring independent from inflation deflation ports as mentioned elsewhere. Similar arrangement can be made for distal constriction ring.

[00100] The tubing of inflation system is connected to outer surface of proximal inflatable constriction ring. The tubing of inflation system to the distal constriction ring is attached by means of micro-channel running through the intermediate bar. The tubing attaching the inflatable mini-pumps have detachment mechanism close to the proximal constriction ring and part of the tubing that remain attached to ring also has deflation release valve that can be used to deflate the constriction after use. Alternatively, detachable tubing can be directly attached to the inflatable ring in case of proximal ring and constriction ring itself can have pressure release valve. [00101] The constriction ring can also be deflated by connecting the detached tubing and using the release valve of mini-pump. After inflating the rings optimally, the tubing is detached and part of tubing attached to constriction ring- stumps- are stored in a small pocket attached to ring to prevent injury from loose end during intimate contact. The tubing of the inflation mechanism for inflatable ring also has pressure measuring gauge to measure the pressure in the inflatable ring constriction ring. The proximal constriction ring especially with cushion at the Corpus Spongiosum position may be enough to maintain erection of Copora Cavernosa and Comus Spongiosum/ Glans Penis, therefore, distal constriction mechanism may not be necessary.

[00102] As described for other implementations herein, a stretchable beaded ring on the proximal annular band of the device is included, by means of which the testicles can be attached to the device. A small tightening ring is threaded over the beaded ring to tighten or loosen the beaded ring. This arrangement gives the support to main. As result of the stiffness imparted by the external splints encased in flexible skin compatible material, the device can provide erection for successful intercourse in individual with erectile dysfunction. If it is not possible to get erection naturally, one can apply vibratory device as described in other implementations herein or this device can be used with Vacuum Inflatable Constriction Device (VICD) designed for achieving and maintaining erection. The inflation mechanism etc. can be arranged similar to other described implementations. Yet another implementation can include an elongated vibratory unit that extend longitudinally substantially along the entire length of an inflatable splint. An added advantage of the device is that it increases circumference of the penis over the almost entire length of penis.

[00103] One implementation of the present technology includes vibrator sleeve. Referring to Figs. 16 and 17 a vibrator sleeve 1601 is shown. The vibration stimulation of the penis is achieved by an elongated tubular vibrator sleeve 1607 with two elongated dorsolateral vibrators 1604 connected in a side-by-side relationship by a sheath material 1603 thereby forming a sleeve like structure as illustrated in Fig. 16. The outer surface or elongated housing 1602 containing the elongated vibrator unit 1604 can be made of non- resilient material or a pliable material and the inner surface 161 1 is made of skin compatible non- slippery material. The whole vibrator system, includes dual dorso-lateral elongated vibrator units 1604 and in one implementation as shown, a ventral elongated vibrator unit 1612 is included. The ventral vibrator has an extension to cover and stimulate the Frenulum of the penis. . The above vibratory units stimulate the branches of Dorsal Nerve and Perennial Nerve. Additional vibratory units may be placed if requires. The intervening web between the vibratory units is thin and stretchable. Handles 1610 and 1609 can be used to assist in sliding the sleeve over the penis 1708 as well as used to urged the vibrator units against the surface of the penis. The vibration control unit is powered and has a controller and transmitter. The controller is configured to control the transmitter to transmit controls signals to the vibrator units to power them the turn them on as well as control the level of vibration forces being applied.

[00104] One implementation of the technology includes multiple elongated vibrators extending in parallel longitudinally can be utilized. Annular bands can be attached at the proximal and distal ends of the vibrators. One implementation of the technology includes stretchable smaller constriction rings like structures attached to above mentioned proximal and distal annular bands to help prevent venous outflow and also help keep the device in position. These structures have non-slippery inner surface. Another implementation of the technology as described has, in lieu of the stretchable smaller rings like structures attached to above mentioned proximal and distal annular bands as described, inflatable constricting rings to control venous outflow and help anchor the device to penis as a secondary benefit. As discussed the venous outflow is significant factor in in causing erectile dysfunction in many middle aged and most elderly patients and in selected patients at younger age.

[00105] Similar to other implementations, the constriction ring includes an inflation mechanism; an inflatable annular ring encircling the base of penis and an inflatable ring encircling the base of Glans. The outer surface of such ring can be made of non- resilient material and inner surface can be made of skin compatible preferably non-slippery material. Any material can be used that will provide the inflation constriction mechanism. This ring can be inflated by air or liquid. The inflatable constriction ring mechanism includes a manual or a battery powered mini-pump.

[00106] Similar to other implementations, the mini-pumps are attached to the inflatable constriction rings by detachable tubing either directly to the inflatable ring or by means of small tubing attached to above ring. The proximal inflatable constriction ring has proj ections on the inner surface that cover the dorsal and dorsolateral position of the penis at the base corresponding to penile veins. Similar to other implementations, one implementation of the ring has a continuous cushion covering the dorsal and dorsolateral position of the penis. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patient requiring high pressure in the ring to control venous leak. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein.

[00107] The device can also be used for diagnostic purposes to investigate the effect of vibration on penile blood flow. The proximal annular band is removed at the ventrolateral aspect in order to gain an access for Duplex ultrasound probe to cavemosal artery close to the base of penis. The device is held in position by mean of elastic band wrapped around the device surrounding the penis during the diagnostic procedure. [00108] The aim of this invention is to provide stimulation of the erection by means of vibration applied to penis, its nerves; Dorsal Nerve, Perineal Nerve, and Cavernous Nerve through its connection. This device can be used for penile rehabilitation, and by individual with erectile dysfunction who need or prefer to use vibration but do not want to wear vibratory device during intercourse. These patients can attain the erection by vibratory stimulation and may or may not need additional assistive devices described in other sections.

[00109] Referring to Figs. 20 A, 20B, 20C, different configurations of the projections on the inflatable constriction device (ICD) or pliable constriction ring structure are illustrated. Referring to Fig. 20 B, the dorsal projection causes pressure on the dorsal vein to impede venous outflow. Referring to Fig 20 A, the dorsolateral 2002 and ventrolateral 2003 projections, which project diametrically inward to compress the root of penis diagonally to impede venous outflow from corpora cavernosa. Referring to Fig. 20 B, diametrically opposing lateral projections 2004 to compress the root of penis to from sides to impede venous outflow from corpora cavernosa. Referring to Fig.20 C, lateral projections 2006 to compress the root of penis to from sides to impede venous outflow from corpora cavernosa, different shape. One implementation of the constriction ring as shown in Figs. 20A - 20C is an inflatable constriction ring including an exterior wall enclosing an interior bladder and configured such that the interior portion of the ring diametrically expands inwardly to thereby apply an inward pressure or force against the skin of the user. Yet another implementation of the constriction ring is a pliable constriction ring that is forceably expanded diametrically outward to fit over the penis of the user such that when it is installed the constriction ring applies an inward pressure or force against the penis of the user as the ring attempts to take on it original unexpanded form factor.

[00110] Similar to other implementations, the mini-pumps are attached to the inflatable constriction rings by detachable tubing either directly to the inflatable ring or by means of small tubing attached to above ring. The proximal inflatable constriction ring has proj ections on the inner surface that cover the dorsal and dorsolateral position of the penis at the base corresponding to penile veins. Similar to other implementations, one implementation of the ring has a continuous cushion covering the dorsal and dorsolateral position of the penis. The cushion at dorsolateral position may impede the arterial flow in dorsal arteries in patient requiring high pressure in the ring to control venous leak. In this situation just one dorsal cushion may be more beneficial to compress the dorsal vein.

[00111] The dorsolateral cushions can be placed further laterally to avoid pressure on the dorsal artery and ventral end stiffening can be extended more laterally and ventrilateral stiffened area is reinforced with cushion. In one implementation the proximal ring has a groove at the position corresponding to urethra in addition to above proj ections/ cushions, however, the distal inflatable ring has only groove for urethra. The grooves are kept in place by reinforcing ventral ends with stiffening material/mechanism. The end of the ring towards urethral area of penis are reinforced with stiffing material and stiff bar that bridges the gap between the two stiff ends. Two attachments are attached that are oblique between the end of ring and stiff bar further anchor the ends of ring to the bar to prevent ends of the ring to push inwards dorsally. The groove allows the free passage of ejaculate, however, groove may allow venous outflow from the Corous Spongiosum causing loss of erection, particularly for the glans penis. To address above problem the urethral groove can be eliminated and replaced with bulge or cushion at the Corous Spongiosum position. Arrangement for deflation of ring can made by manual or remote control mechanism to facilitate the natural ejaculation by having deflation port/knob on the ring independent from inflation deflation ports as mentioned elsewhere. Similar arrangement can be made for distal constriction ring.

[00112] The constriction ring can also be deflated by connecting the detached tubing and using the release valve of mini-pump. After inflating the rings optimally, the tubing are detached and part of tubing attached to constriction ring- stumps- are stored in a small pocket attached to ring to prevent injury from loose end during intimate contact. The tubing of the inflation mechanism for inflatable ring also has pressure measuring gauge to measure the pressure in the inflatable ring constriction ring. The proximal constriction ring especially with cushion at the Corpus Spongiosum position may be enough to maintain erection of Copora Cavernosa and Comus Spongiosum/ Glans Penis, therefore distal constriction mechanism may not be necessary.

[00113] The various implementations and examples shown above illustrate a method and apparatus for constricting blood flow and providing stimulus. A user of the present method and apparatus may choose any of the above implementations, or an equivalent thereof, depending upon the desired application. In this regard, it is recognized that various forms of the subject constriction and stimulus method and apparatus could be utilized without departing from the scope of the present technology and various implementations as disclosed.

[00114] As is evident from the foregoing description, certain aspects of the present implementation are not limited by the particular details of the examples illustrated herein, and it is therefore contemplated that other modifications and applications, or equivalents thereof, will occur to those skilled in the art. It is accordingly intended that the claims shall cover all such modifications and applications that do not depart from the and scope of the present implementation(s). Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. [00115] Certain systems, apparatus, applications or processes are described herein as including a number of modules. A module may be a unit of distinct functionality that may be presented in software, hardware, or combinations thereof. When the functionality of a module is performed in any part through software, the module includes a computer-readable medium. The modules may be regarded as being communicatively coupled. The inventive subj ect matter may be represented in a variety of different implementations of which there are many possible permutations.

[00116] The methods described herein do not have to be executed in the order described, or in any particular order. Moreover, various activities described with respect to the methods identified herein can be executed in serial or parallel fashion. In the foregoing Detailed Description, it can be seen that various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may lie in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.

[00117] The various implementations and examples shown above illustrate a method and apparatus for addressing erectile dysfunction. A user of the present technology as disclosed may choose any of the above implementations, or an equivalent thereof, depending upon the desired application. In this regard, it is recognized that various forms of the subject erectile dysfunction device could be utilized without departing from the scope of the present invention.

[00118] Other aspects, obj ects and advantages of the present technology as disclosed can be obtained from a study of the drawings, the disclosure and the appended claims.