AU2016273950A1 - Improvements in Phalloplasty - Google Patents

Abstract

A method of widening a penis wherein the penis is degloved, a graft is sutured to the exposed Bucks fascia and then reducing the penile skin; the method further including the step of following with a post-operative treatment regime.

Description

ι 2016273950 15 Dec 2016

IMPROVEMENTS IN PHALLOPLASTY RELATED APPLICATIONS DATA

This application is a divisional application of Australian Patent Application No. 2014218383 filed 26 August 2014, which is in turn a divisional application of Australian Patent 5 Application No. 2012202598 filed 3 may 2012, which is in turn a divisional application of Australian Patent Application No. 2009212955 filed 4 September 2009, which is in turn a divisional application of Australian Patent Application No. 2003213860 which is the Australian national phase filing of International Patent Application No. PCT/AU2003/000400 (publication No. WO 2003/082120) filed on 3 April 2003, which claims priority from Australian Patent 0 Application No. 2002031403 filed 3 April 2002, the contents of each of the above mentioned applications are incorporated herein in their entirety by way of reference.

FIELD OF THE INVENTION

This present invention relates to enhancement phalloplasty, which is a surgical procedure to modify the human penis, normally by increasing the length of or widening the 5 penis.

BACKGROUND OF THE INVENTION

There are several reasons for persons requiring operations of this type. The first is for persons who are bom with small penises. These persons can often believe that they are the subject of derision and ridicule and the lack of size of the appendage can be emotionally very -0 difficult for them. A second is where persons, either for personal pleasure or for professional reasons, such as strip-tease dancers, actors and the like, wish to be seen to have a large penis.

There have been previously proposed methods of enhancement phalloplasty but these have not been fully successful. 25 In one example, the present invention provides methods of enhancement phalloplasty which provide satisfactory results and which are safe procedures and which result in lengthening the penis in both the flaccid and erect states.

The applicant has disclosed basic surgical procedures in earlier filed patent applications including Australian Patent Applications 28601/97, 53864/98 and 79900/98. 30 However these applications are for a base surgical procedure. In one example the present 2 2016273950 15 Dec 2016 invention combines those surgical procedures and others with post-operative treatment methods thereby to maintain the outcome of the basic surgical procedure.

SUMMARY OF INVENTION

Accordingly, in one broad form of the invention there is provided a method of 5 lengthening the penis of a male patient. The method includes placing the suspensory ligament of the penis under tension in the inferior direction. The method also includes dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami. The method further includes suturing an acellular matrix graft to the exposed Bucks fascia. 0 Preferably, the method further includes effecting suturing to retain the penis released from the suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled to the released penis, and dividing the fundiform ligaments of the penis.

Preferably, the method includes drawing the skin of the junction site of the scrotum 5 and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position.

Preferably, the method further includes inserting additional sutures through the anterior surface of the symphysis pubis, and placing said sutures through the margins of the 0 pubic skin wound; and tying said sutures in a manner sufficient as to pull a corporal cylinder skin down infrapubically.

In one example, the number of said additional sutures inserted is 1 or more.

In another example, the number of said additional sutures inserted is determined by the width of the symphysis pubis. 25 Preferably, the method includes dividing the fundiform ligament prior to drawing the skin of the junction site of the scrotum.

In one example, the method includes suturing the acellular matrix graft to the exposed Bucks fascia prior to tying the sutures which maintain the lengthening of the penis. For example, the method may include degloving the penis, and suturing the acellular matrix graft to 30 the exposed Bucks fascia. Preferably, the method includes degloving the penis, suturing the acellular matrix graft to the exposed Bucks fascia and then reducing the penile skin. 3 2016273950 15 Dec 2016

In one example, the method is performed in a patient who is about to have or already has in place an artificial erection device, wherein said penis having a structure including a first corpus cavemosum, a second corpus cavemosum, a corpus spongiosum, a Buck’s fascia and a dorsal neurovascular bundle. According to this example, the method includes degloving the 5 penis to expose the Buck’s fascia, freeing the dorsal neurovascular bundle and separating the corpus spongiosum from the inferior surface of both said first and said second corpus cavemosum, and dividing said first and second corpus cavemosum circumferentially.

Preferably, the step of separating the corpus spongiosum from the inferior surface of both said first and said second corpus cavemosum comprises a dissection so as to enable the 0 first and second corpus cavemosum to be elongated without dividing the corpus spongiosum.

Optionally, the method is performed in a patient who already has in place an artificial erection device and said artificial erection device comprises a corporal cylinder; and wherein a corporal cylinder to be used is longer than the corporal cylinder presently in place, either where the patient already has an artificial erection device in place or longer than a corporal cylinder 5 which was measured when a corporotomy and dilatation of the corpus was performed earlier in the procedure.

The increase in length of the corporal cylinder is optionally of the order of one or more cm.

Preferably, the method includes filling a gap formed in the first or second corpus 0 cavemosum by suturing in place an acellular matrix graft.

For example, the method may include suturing the acellular matrix graft to the exposed Bucks fascia, and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavemosum, suturing the edges of the graft to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavemosum without 25 dividing the graft as a separate phenomenon or step.

Optionally, when the patient has a thickened wall of the first or second corpus cavemosum, the method includes placing a first acellular matrix graft into the defect in the Buck’s fascia and then placing a second acellular matrix graft into the defect superficial to said first dermal fat graft. For example, when the patient has a thickened wall of the corpus 30 cavemosum, the method may include filling the gap in the wall of the corpus cavemosum using a gortex graft or a saphenous vein patch or a non- saphenous vein patch or a temporalis fascia or fascia lata or dexon mesh or silastic sheeting; and then applying said second acellular matrix graft. 2016273950 15 Dec 2016 4

Alternatively, or in addition, the method according to this example, may include reducing the degloved penis, trimming the proximal wounds and closing the proximal wounds in layers. 5 In one example, the acellular matrix graft employed in the method according to this broad form comprises acellular cadaveric dermal tissue. Preferably, the acellular matrix graft comprises acellular dermal matrix tissue selected from bovine pericardium, human dermis, porcine dermis, and small intestinal submucosa.

For example, the method according to this broad form further includes performing a 0 treatment for buried penis condition.

Alternatively, or in addition, the method may further include performing a postoperative treatment regime. Alternatively, or in addition, the method may further include performing post-operative penile scar stretching exercises e.g., by the patient.

In one example, the method includes performing by the patient a post-operative penile 5 scar stretching exercises. For example, performing post-operative penile scar stretching exercises comprises performing one or more exercises selected from: (a) an exercise wherein the patient stands with his right leg flexed to about 90 degrees at the right hip joint and his right foot is resting on an object such that his right knee is also at a right angle, and wherein said exercise comprises the patient 0 passing the patient’s right hand around, under and inside the patient’s right thigh, grasping the glans of the penis using the index finger and thumb of the patient’s right hand, and pulling the grasped glans of the penis downwardly and backwardly so that the 25 penis is pulled down and back between the patient’s testicles and back towards the patient’s anus; and (b) an exercise wherein the patient stands with his left leg flexed to about 90 degrees at the left hip joint and his left foot is resting on an object such that his left knee is also at a left angle, and wherein said exercise comprises the patient 30 passing the patient’s left hand around, under and inside the patient’s left thigh, grasping the glans of the penis using the index finger and thumb of the patient’s left hand, and pulling the grasped glans of the penis downwardly and backwardly so that the 5 2016273950 15 Dec 2016 penis is pulled down and back between the patient’s testicles and back towards the patient’s anus.

Preferably, the method comprises performing exercise (a) above wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period 5 of at least about 20 seconds, and/or performing exercise (b) above wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of at least about 20 seconds.

Preferably, the method comprises performing both post-operative penile scar stretching exercises (a) and (b) above, wherein exercise (a) is performed at least five times and 0 exercise (b) is performed at least five times, optionally wherein the patient rests for about one second between consecutive times where each of said exercise (a) or (b) is performed.

For example, the method may comprise performing by the patient the following steps: (i) performing exercise (a) five times wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of about 20 seconds each 5 time said exercise (a) is performed; (ii) performing exercise (b) five times wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of about 20 seconds each time said exercise (b) is performed; and (iii) repeating steps (i) and (ii) . According to this example, the method comprises the patient performing steps (i) to (iii) three times per day. Optionally the patient performs steps (i) to (iiii) during the morning upon 0 getting out of bed, and then performs steps (i) to (iii) in the afternoon and/or evening, and then performs steps (i) to (iii) prior to going to bed at night.

In yet another example of a method according to this broad form, the method includes administering to the patient a post-operative drug treatment regime to (a) control or prevent penile wound infection, and/or (b) suppress penile erection, and/or (c) prevent or reduce penile 25 tissue swelling.

Preferably, administering to the patient a post-operative drug treatment regime comprises administering to the patient one or more drugs selected from (i) cephalexin monohydrate, (ii) a combination of amoxycillin trihydrate and clavulanic acid, (iii) alprazolam, (iv) a tirazole antifungal compound such as fluconazole, (v) ketoconazole, (vi) a combination of 30 paracetamol, codeine and doxylamine succinate, and (vii) prednisone..

For example, the method may comprise administering to the patient orally (i) cephalexin monohydrate at a dosage of about 500mg, three times a day for about 14 days; and/or (ii) a 6 2016273950 15 Dec 2016 combination of amoxycillin trihydrate and clavulanic acid at a dosage of about 875mg of amoxycillin and about 125 mg of clavulanic acid, twice a day for about 14 days; and/or (iii) alprazolam at a dosage between about 0.5 mg to about 1.0 mg, three times a day for about 14 days; and/or (iv) a tirazole antifungal compound such as fluconazole at a dosage of between 5 about 100 mg to 400mg, two to three times a day for at least about 14 days, or ketoconazole at a dosage of about 400mg three times a day for about 14 days; and/or (v) a combination of paracetamol, codeine phosphate and doxylamine succinate at a dosage of about 900 mg of paracetamol, about 60mg of codeine phosphate and about lOmg of doxylamine succinate once a night for about 14 nights, and/or (vi) prednisone at a dosage of about lOmg three times a day 0 for about five days, followed by about lOmg twice a day for about three days, followed by about 5mg twice a day for about two days followed by about 5mg once a day for about two days.

Preferably, the method comprises administering to the patient an amount of fluconazole. The tirazole antifungal compound such as fluconazole may be administered orally 5 and/or intravenously. The tirazole antifungal compound such as fluconazole may be administered orally or intravenously post-operatively at an amount from about lOOmg to about 1200mg or in an amount of more than about 1200mg (such as lOOmg, 150mg, 200mg, 250mg, 300mg, 350mg, 400mg, 500mg, 600mg or more than 600mg) per day. Optionally, fluconazole is administered orally post-operatively to the patient at a dosage from about lOOmg to about 0 400mg, two to three times per day for two or more weeks.

In one example, the method comprises administering to the patient post-operatively (i) cephalexin monohydrate; (ii) a combination of amoxycillin trihydrate and clavulanic acid; (iii) alprazolam; (iv) fluconazole; (v) a combination of paracetamol, codeine phosphate and doxylamine succinate; and (vi) prednisone. 25 Accordingly, in another broad form of the invention there is provided a method for penile enlargement further including the step of application of a post-operative treatment regime.

Accordingly, in another broad form of the invention there is provided a method for penile enlargement further including the step of application of a post-operative treatment regime thereby to maintain outcome of enlargement. 30 Accordingly, in yet another broad form of the invention there is provided a method of widening a penis wherein a dermal fat graft comprising a block of fat and attached dermis is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed 7 2016273950 15 Dec 2016

Bucks fascia and then reducing the penile skin; the method further including the step of following a post-operative treatment regime.

Preferably the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen. 5 Accordingly, in yet another broad form of the invention there is provided a method of lengthening the penis of a male which includes the steps of placing the suspensory ligament under tension in the inferior direction; dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami; effecting suturing to retain the penis released from the 0 suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled the released penis, dividing the fundiform ligaments, drawing the skin of the junction site of the scrotum and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position; the 5 method further including the step of following a post operative treatment regime.

Preferably followed by the insertion of additional sutures through the anterior surface of the symphysis pubis; the sutures also placed through the margins of the pubic skin wound and tied in such a manner as to pull suprapubic skin down infrapubically.

Preferably the number of the additional sutures inserted is 1 or more. 0 Preferably the number of the additional sutures is determined by the width of the symphysis pubis.

Preferably including the step of dividing the fundiform ligament prior to the step of drawing the skin of the junction site of the scrotum.

Accordingly, in yet another broad form of the invention there is provided a method 25 of widening a penis wherein a block of fat and attached dermis (dermal fat graft) is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed Bucks fascia and then reducing the penile skin.

Preferably the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen. 30 Preferably the dermal fat graft is sutured to the exposed Bucks fascia prior to the 8 tying of the sutures which maintain the lengthening of the penis. 2016273950 15 Dec 2016

Accordingly, in yet another broad form of the invention there is provided a method of enhancement phalloplasty of a human penis in patients who are about to have or already have in place an artificial erection device; the penis having a structure including a first corpus 5 cavemosum, a second corpus cavemosum, a corpus spongiosum, a Buck’s fascia and a dorsal neurovascular bundle; the method including the steps of degloving the penis to expose the Buck’s fascia; freeing the dorsal neurovascular bundle and separating the corpus spongiosum from the inferior surface of both the first and the second corpus cavemosum; dividing the first and second corpus cavemosum circumferentially; the method further including the step of 0 following a post-operative treatment regime.

Preferably the step of separating the corpus spongiosum from the inferior surface of both the first and the second corpus cavemosum comprises a dissection so as to enable the first and second corpus cavemosum to be elongated without dividing the corpus spongiosum.

Preferably the artificial erection device comprises a corporal cylinder which is 5 longer than the corporal cylinder presently in place, either where the patient already has an artificial erection device in place or longer than the corporal cylinder which was measured when the corporotomy and dilatation of the corpus was performed earlier in the procedure.

Preferably the increase in length of the corporal cylinder is of the order of one or more cm. 0 Preferably a gap formed in the first or second corpus cavemosum and is filled by suturing in place an inverted dermal graft from which the epidermis has been removed.

Preferably the dermo epidermal surface is the inner most surface applied to the corporal cavity.

Preferably widening of the penis is also required and wherein widening is effected by 25 using a dermal fat graft.

Preferably the fat graft is sutured to the exposed Bucks fascia and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavemosum the edges of the graft are sutured to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavemosum without dividing the graft as a separate 30 phenomenon. 9 2016273950 15 Dec 2016

Preferably if the patient has a very thickened wall of the first or second corpus cavemosum, a first dermal fat graft is placed into the defect in the Buck’s fascia and then a second dermal fat graft is placed into the defect.

Preferably if the patient has a very thickened wall of the corpus cavernosum, the gap in 5 the wall of the corpus cavernosum is fdled by using a gortex graft, a saphenous or other vein patch, temporalis or other fascia such as the fascia lata or dexon mesh or silastic sheeting or other appropriate material and then the second dermal fat graft is applied.

Preferably the method further including an additional step wherein the degloved penis is reduced and the proximal wounds are trimmed and closed in layers. 0 Accordingly, in yet another broad form of the invention there is provided a method of enhancement phalloplasty substantially as hereinbefore described with reference to the examples of the particular operations given in the specification.

Preferably penile enlargement comprises one or more of lengthening or widening.

Preferably further including the step of treatment for buried penis condition. 5 Preferably the post-operative treatment regime comprises application of a drug treatment regime.

Preferably the post-operative treatment regime comprises application of an exercise regime.

Accordingly, in yet a further broad form of the invention there is provided an 20 exercise regime for application following application of the above described method.

Accordingly, in yet a further broad form of the invention there is provided a drug treatment regime for application following application of the above described method.

Accordingly, in yet a further broad form of the invention there is provided a method of lengthening and widening a penis, the lengthening using the method as described above 25 wherein a block of fat and attached dermis (dermal fat graft) is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.

Accordingly, in yet another broad form of the invention, there is provided a method of lengthening the penis of a male, which includes the steps of placing the suspensory ligament ίο 2016273950 15 Dec 2016 under tension in the inferior direction; dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami; the method further including the step of following a with post operative treatment regime. 5 Preferably, the method further includes the step of effecting suturing to retain the penis released from the suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled to the released penis, dividing the fundiform ligaments.

Preferably, the method further includes the step of drawing the skin of the junction 0 site of the scrotum and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position.

In a further broad form of the invention, there is provided a method of widening a penis wherein the penis is degloved, an acellular matrix graft is sutured to the exposed Bucks 5 fascia and then reducing the penile skin; the method further including the step of following with a post-operative treatment regime.

In yet another broad form of the invention, there is provided a method of widening a penis wherein the penis is degloved, an acellular matrix graft is sutured to the exposed Bucks fascia and then reducing the penile skin. 0 Preferably the acellular matrix graft is sutured to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.

Preferably a gap formed in the first or second corpus cavemosum is filled by suturing in place an acellular matrix graft.

Preferably widening of the penis is also required and wherein widening is effected by 25 using an acellular matrix graft.

Preferably the acellular matrix graft is sutured to the exposed Bucks fascia and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavernosum the edges of the graft are sutured to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavernosum without 30 dividing the graft as a separate phenomenon. 11 2016273950 15 Dec 2016

Preferably if the patient has a very thickened wall of the first or second corpus cavemosum, a first acellular matrix graft is placed into the defect in the Buck’s fascia and then a second acellular matrix graft is placed into the defect superficial to the first acellular matrix graft. 5 Preferably if the patient has a very thickened wall of the corpus cavemosum, the gap in the wall of the corpus cavemosum is filled by using a gortex graft, a saphenous or other vein patch, temporalis or other fascia such as the fascia lata or dexon mesh or silastic sheeting or other appropriate material and then the second acellular matrix graft is applied.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 0 In order that preferred embodiments of the invention may be more readily understood, described herein below are certain exemplary procedures in greater detail.

The first of these has to do with penile enlargement. This involves suprapubic (or other type) incision and exposure of the suspensory and fundiform ligaments of the penis and their division under direct vision from the suprapubic area and the inferior bodies of the pubic 5 arch (i.e. all of the antero-inferior surface of the pubic symphysis. The penis is depressed posteriorly by approximating the medial edges of the upper ends of the right and left Gracilis muscle in front of the penis. The suprapubic skin is rearranged (by Zplasty, excision or a combination of both) and sutured together and to the superior and anterior surfaces of the body of the pubis right and left. 0 To aid in the full understanding of the invention, the procedures of preferred embodiments are more fully described below:

PENILE LENGTHENING

With the patient under general aesthesia and in the supine position the lower abdomen, perineum and thighs are prepared and draped. In the classic procedure, a transverse suprapubic 25 incision is made measuring approximately 3cm in length. Various other incisions can be used such as W plastys, Z plastys, vertical and peno-scrotal incisions and the like.

The incision site and the adjacent mons tissues are infiltrated with local anaesthetic and adrenalin. The tissues overlying the mons veneris are separated laterally and the fundiform and suspensory ligaments of the penis are visualized. 30 Dissection is carried down by a blunt technique on either side of the suspensory 12 2016273950 15 Dec 2016 ligament which is then divided under direct vision using diathermy. The dissection is carried out against the body of the symphysis pubis down to the inferior pubic arch level and along the conjoined rami of ischium and pubis for a short distance. During the maneuver the assistant pulls the penis in an inferior direction placing the ligament under tension and it can be seen 5 under direct vision and the neurovascular bundles can also be directly visualized and preserved.

At this point, an O Maxon (or other suture material) deep stay suture is inserted into the deep surface of the pubic symphysis and then carried around the right Gracilis fascia and muscle across to the left Gracilis fascia and muscle and the suture left loose. A second O Maxon (or other suture material) is then inerted distal to the first suture so as to further coapt the 0 right and left Gracilis muscles in front of the penis. Two more deep stay sutures of O Maxom (or other suture material) are then inserted into the pubic bone inferior surface laterally and left untied. A fifth, sixth and seventh O Maxon (or other suture material) suture are placed into the very superior edge and anterior surface of the exposed symphysis pubis and left untied.

The first deep stay suture of O Maxon is then tied commencing with the one involving 5 both Gracili which can be observed to approximate in front of the inferiorly depressed shaft of the penis followed by tying the second O Maxon Gracilis suture. The tissues on each side of the mons veneris at this point are then dissected and the fundiform ligaments which are now clearly outlined as a result of this dissection are also divided under direct vision down to but not including the tissues overlying the spermatic cords on either side. The junction of the 0 perineal and scrotal skin on either side is then identified approximately 3cm lateral to the midline and one each of the remaining third and fourth O Maxon (or other suture material) sutures is/are inserted into the deep layers of the dermis of the scrotum on each side and the sutures tied. This draws the skin of the junction side of the scrotum and perineum mediosuperiorally pushing the skin adjacent to it along the newly exposed shaft of the penis. 25 The fifth, sixth and seventh O Maxon suture are inserted into the deep layers of the suprapubic incision in the centre and on either side and are tied so as to gently curve the skin of the mons veneris down over the top of the symphysis pubis further aiding the movement of the abdominal skin onto the new penile shaft.

After trimming the wound is closed in layers and dressings are applied.

30 PENILE WIDENING - DERMAL FAT GRAFT

With the patient under satisfactory general aesthesia and in the prone position, the buttock, anal area and thighs are prepared and draped. The areas of incision at the 13 2016273950 15 Dec 2016 buttock/thigh fold on both legs, which were previously marked, are infiltrated with a mixture of local anaesthetic and adrenalin and then the outer layers of the epidermis are dissected off over an area measuring of the order of 5 x 10cm or more cms. The actual size will be determined by the initial size of the penis measured preoperatively. Once the epidermis has been 5 dissected free it is discarded. The exposed dermis, together with its layer of subtenant fat measuring approximately 2cm deep is excised en bloc using a mixture of cautery and sharp dissection.

The graft is then wrapped in a pack soaked in cold Ringer’s solution and kept at room temperature (0 to 10 degrees Centigrade). The wound is closed in layers. Dressings are 0 applied.

The patient is then turned from the prone to the supine position while still anaesthetized and the lower abdomen, perineum and thighs prepared and draped.

The area of the incision is then infiltrated with a mixture of local anaesthetic and adrenalin. 5 If widening is done in conjunction with lengthening, the incision is usually transverse though it may be any combination of the incisions described under lengthening, above including the peno-scrotal incision. If widening is done alone then a transverse suprapubic incision is usually used although any of the above incisions may be used.

If the patient is already circumcised, infiltration of the old circumcision scar in its 0 anterior half may also be carried out. If the patient is not circumcised it is necessary to proceed to circumcision usually, as this is a requirement for dermal fat grafting usually (though not always), then the entire circumference of the penis at the proposed circumcision site is infiltrated with local anaesthetic and adrenalin.

If the peno-scrotal approach is being used with degloving of the penis, then a 25 completely circumferential infiltrate with local anaesthetic is used whether the patient is circumcised or not.

Once the incision, be it peno-scrotal, or more commonly transverse suprapubic, has been carried down to the deeper layers by blunt dissection, the skin and superficial fascia of the penis is separated from the shaft of the underlying penis in its entire length and 30 circumference. 14 2016273950 15 Dec 2016

At this point, the anterior half of the old circumcision scar may be reopened (in the case of the suprapubic transverse incision) or the entire old circumcision scar or a new circumcision site is opened in the case of the uncircumcised who require circumcision, and in the case of the peno-scrotal approach in the former. The penis is then degloved. The dermal 5 fat graft is then sutured to the exposed Bucks fascia commencing on the coronal groove distally and going as far proximally as is possible with the wound exposure. This should be at least well down into the infra pubic region of the symphysial or mid-portion of the penile shaft. The graft is attached all around the shaft of the penis leaving only the corpus spongiosum exposed.

The penile skin is then reduced, the circumcision wound (if applicable) is then closed 0 as is the peno-scrotal incision if it has been used after the dartos fascia has been closed.

If the suprapubic incision has been used it is closed in layers. Telfa is applied to the wounds and the penis is encased in a crepe bandage as a moderately compressed dressing.

PENILE WIDENING - ACELLULAR MATRIX GRAFT

Penile widening may also be achieved by substituting the dermal fat grafts with an 5 acellular matrix graft. These grafts may include one of the commercially available acellular biological matrix grafts made from Bovine Pericardium, human Dermis, Porcine dermis or small intestinal submucosa. These grafts are caderveric acellular tissue-regenerative matrixes and serve as a framework to support repopulation with the patient’s own cells and blood vessels.

These grafts are placed in the same layer as, and utilising the same technique as, used 0 for the dermal fat grafts. The operative approach is the same as that used for dermal fat grafting but takes less time and results in a shorter operating time than when using the dermal fat grafts.

COMBINED PENILE LENGTHENING AND WIDENING

With the patient in the prone position, the dermal fat grafts are harvested as described above. The patient is then turned to the supine position and the operation proceeds as 25 described under penile lengthening to the point where all of the deep stay sutures are in place but not tied. At this time, the distal circumferential incision (circumcision site incision if required) is performed, the penile skin is developed and the penis degloved. The dermal fat graft is then sutured into place as described above.

Once the penile skin has been reduced, the deep stay sutures are then tied as 30 described above in regard to penile lengthening and attached to their other structures. All 15 wounds are then closed as described above. 2016273950 15 Dec 2016

POST-OPERATIVE TREATMENT REGIMES

The abovementioned procedures advantageously are applied in combination with one or more of the following post-operative treatment regimes, namely either one or both of the 5 stretching exercise or the drug treatment regime.

POST-OPERATIVF. PF.NTT ,H SCAR STRETCHING EXERCISE THE EXERCISE: The patient stands with the right (left) leg flexed to 90 degrees at the right (left) hip joint.

The Right (left) foot is resting on a chair or stool such that the right (left) knee is also 0 at a right angle.

The right (left) hand is passed around the right (left) thigh from outside, under, & inside the right (left) thigh & using the index finger & thumb of the right (left) hand the Gians (head) of the penis is grasped (only the Gians & NO part of the shaft skin) & pulled down & back so that the penis is pulled down & back between the Testicles & back towards the Anus. The 5 patient pulls as hard as he can tolerate & should feel a strong pulling sensation at the base of the penis. TIMING: The exercise consists of ten (10) pulls, five (5) using the right hand and leg, and five (5) using the left hand and leg. Each pull is for twenty (20) seconds and the patient may time this using a clock or simply count 1 & ,2 &, 3 & ,4 &, 5 &, 6 &, 7 &, 8 &, 9 20 &, 10 etc. &. The patient rests for one (1) second reapplies his grip to the Gians and pulls again for another twenty (20) seconds.

This is repeated for ten (10) pulls each for twenty (20) seconds. Ten (10) such pulls, each for twenty (20) seconds constitute one block of exercises. The patient is required to perform three blocks per day viz., one block on first getting out of bed in the morning, one 25 block when he gets home from work, and one block just prior to going to bed at night (a total of sixty (60) pulls per day in three blocks of twenty pulls).

It is to be understood that one can use a variety of combinations of timing and number of pulls. Each pull will always be for twenty seconds, or multiples of 10 seconds.

The number of pulls may vary and may be in excess of 100. The preferred number of 30 exercise blocks per day is normally 3, but this may be varied to suit the specific situation. 16 2016273950 15 Dec 2016

Preferred ranges: 20 seconds minimum with an absolute maximum of 30 seconds. Multiples of this period may run up to a maximum of 100 seconds. A possible formula to use to determine the overall regime is: pulls x seconds x repetition regime (minimum 1200, maximum 1800) which can be termed the penile scar 5 ergonomic factor.

The above regime can be used following one or more of the following operative procedures:

POST OPERATIVE DRUG TREATMENT REGIME A treatment regime which can be used to advantage in respect of any of the above 0 described procedures.

Initially, post-operatively a drug treatment regime can include one or more of the following:

Cephalexin (Monohydrate) which is also known by the chemical name 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate - 500mg orally three 5 times a day for 14 days - controls gram positive organisms, particularly Staphylococcus (sometimes called “Staph”) and the like;

Combination: Amoxycillin (Trihydrate) and Clavulanic Acid e.g., Augmentin® Duo Forte tablets (whereby each tablet containing 875mg of amoxycillin and 125 mg of clavulanic acid) -one tablet twice a day orally for two weeks - used against bacteria and other organisms not 20 commonly found at the operation site so as to lower wound infection rate;

Alprazolam (other chemical name: 8-Chloro-l-methyl-6-phenyl-4H-s-triazolo [4,3-a] [1,4] benzodiazepine) 0.5-1 mg orally three times a day for two weeks to suppress erections;

Azole antifungal compound such as ketoconazole (±)cis-l-Acetyl-4-[p-[[2-(2,4-25 dichlorophenyl)-2-(imidazol-l-ylmethyl)-l,3-dioxolan-4-yl]methoxy]phenyl]-piperazine (also known inter alia as (+)-Ketoconazole; Nizoral; Kuric; and (2R,4S)-ketoconazole) - about 400mg e.g., orally, post-operatively three times per day for two weeks - again to suppress erections. Alternatively, or in addition, a tirazole antifungal compound is used such as fluconazole (i.e., 2-(2,4-Difluorophenyl)-l,3-bis(lH-l,2,4-triazol-l-yl)propan-2-ol) is administered orally or 30 intravenously to the patient- again to suppress erection. Tirazole antifungal compounds such 17 2016273950 15 Dec 2016 as fluconazole have improved safety and absorption when administered e.g.,orally. A tirazole antifungal compounds such as fluconazole can be administered orally or intravenously post-operatively at an amount from about lOOmg to about 1200mg or in an amount of more than about 1200 mg (such as lOOmg, 150mg, 200mg, 250mg, 300mg, 350mg, 400mg, 500mg, 5 600mg or more than 600mg) per day. For example, a tirazole antifungal compounds such as fluconazole is administered orally post-operatively to the patient at a dosage from about lOOmg to about 400mg, two to three times per day for two or more weeks. Preferably, fluconazole is administered orally post-operatively at a dosage of 400mg three times per day for at least two weeks; 0 Mersyndol Forte® (an international brand of the combination product paracetamol (i.e., N- (4-hydroxyphenyl)ethanamide N-(4-hydroxyphenyl)acetamide)), codeine (i.e., (5α,6α)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol) and doxylamine succinate (chemical formula C21H28N2O5); whereby each tablet or capsule of Mersyndol Forte® contains 450mg paracetamol, 30mg codeine phosphate and 5mg Doxylamine Succinate) - 2 capsules at night for 5 two weeks - again to suppress erection;

Prednisone (also known by the chemical name: prcgna-1,4-dicnc-3,11,20-trionc, 17,21-dihydroxy; a synthetic anti-inflammatory glucocorticoid derived from cortisone) - e.g., orally, a regime of lOmg three times a day for five days followed by lOmg twice a day for three days followed by 5mg twice a day for two days followed by 5mg once a day for two days - for the purpose of 0 minimising the amount of local tissue swelling.

TREATMENT OF BURIED PENIS

Now follows a description of the treatment of buried penis by a combination of reconstruction of the pubic area, with elevation of the parapenile and supra-penile tissues so as to reveal the buried penis in conjunction with enhancement phalloplasty as described 25 above.

The purpose of the procedure is to enlarge the penis by recognising that in some individuals in addition to the penis having a small length and diameter it may also be partly buried in a proptosed supra-pubic mound.

When done in conjunction with a phalloplasty the graft donation site can be the 30 supra-pubic area and the size of the incision is largely determined by the size of the graft required to widen the penis by the technique of dermal fat grafting described above. 18 2016273950 15 Dec 2016

The incision (previously determined by the size of required grafts for widening) is an elliptical incision widest in the midline and narrowest laterally both right and left and is made in the supra-pubic area and a block of skin and fat is removed down to the level of the external oblique. Dermal fat grafts are harvested from this excised skin/fat block which is divided in 5 the midline vertically so as to produce two grafts of equal size.

The grafts are harvested by making an initial incision in the skin and then by sharp dissection removing the epidermis. The resultant dermis and fat block is then excised enmasse divided in two and used as the two grafts. The infra-pubic space is then developed in the same way as for penile lengthening. 0 When the deep stay sutures are in place two x 0 maxon sutures are used to approximate the gracilus in front of the displaced penis and one x 1 nylon deep stay suture is placed in the front of the pubic symphysis and this will be used to bring the skin just proximal to the base of the penis down onto the front of the pubic symphysis.

At this stage the penis is de-gloved and the grafts sutured in place as for penile 5 widening with dermal fat grafts.

After the grafts are in place and the penile skin has been reduced the nylon stay suture is inserted as described and this midline skin proximal to the penis is fixed to the front of the pubic symphysis on its infra-pubic surface. The tissues on either side are then elevated and sutured to the external oblique upon-neurosis using 1 nylon interrupted sutures. 0 Closure of the superior border of the defect created by extracting the grafts is achieved with alOOO. combination of undercutting of the fat against the external oblique upon- neurosis combined with a vertical plication of the external oblique sufficient to allow approximation of the two edges of skin without tension.

Deep stay suture on the front of the symphysis pubis and the attachment of the 25 inferior margin of the wound to the external oblique and the longitudinal plication of the external oblique in order to bring the upper margin down so that closure is achieved without tension and the whole effect being to raise the infra-pubic and para-penile tissues back up onto the upper surface of the pubic bone and lower abdominal wall. ENHANCEMENT WITH ARTIFICIAL ERECTION DEVICE: 30 In its broadest aspect, the invention includes a method of enhancement phalloplasty of 19 2016273950 15 Dec 2016 a human penis including the steps of degloving the penis to expose Buck’s fascia and dividing the corpora cavernosa circumferentially after freeing the dorsal neurovascular bundles and separating the corpus spongiosum from the inferior surface of both corpora cavernosa.

The method can provide an increase in length of the penis of the order of one 5 centimeter and thus the corporal cylinder to be used is longer by this amount than that presently in place or that which was measured when the corporotomy and dilatation of the corpus was performed earlier in the procedure.

The particular application to which the procedure specifically relates is to penile lengthening in patients who are about to have or already have in place an artificial erection 0 device either of the inflatable or solid rod type as treatment for their impotence and who require additional penile lengthening and/or widening.

In association with the method of the invention, a skilled person can also apply the lengthening and widening techniques described earlier in this specification in conjunction with the treatment regimes earlier described. 5 The dissection involves separating the corpus spongiosum from the inferior surface of both corpora cavernosa. Additional length of 1cm or more in the length of the corpus cavemosum can be obtained by this technique and so it will be necessary to either put a 1cm longer corporal cylinder than has already been in place or a 1cm longer cylinder than has been measured at the earlier part of the procedure when the corporotomy and dilatation of the 0 corpus was performed. The gap in the corpus cavernosum is filled by suturing in place an inverted dermal graft from which the epidermis has been removed so that the dermo epidermal surface is the inner most surface applied to the corporal cavity.

Suturing is achieved using a continuous non-absorbable suture of the gortex type and suturing is performed over the deflated corporal cylinder (in the case of inflatable cylinders) 25 or over the rigid non-inflatable intra corporal rod if this has been used.

If widening using a dermal fat graft is also desired then the dermal fat graft is sutured in place generally as described in my earlier patent application but when the graft reaches the defect in Buck’s fascia corresponding to the division of the corpus cavernosum the edges of the graft are sutured to this circumferentially and to the distal portion of the corpus 30 cavemosum without dividing the graft as a separate phenomenon. However in those patients in whom there is a very thickened wall of the corpus cavemosum a better result can be achieved by putting a separate dermal graft into the defect and then applying another dermal 20 2016273950 15 Dec 2016 fat graft more superficially to that as described earlier in this specification. The same result can be achieved by filling the gap in the wall of the corpus cavemosum by using a gortex graft, a saphenous or other vein patch, temporalis or other fascia such as the fascia lata. Even substances such as dexon mesh or silastic sheeting are also theoretically possible. 5 In order that the invention may be more readily understood, one particular operation in which the use of the invention is demonstrated will be described.

This operation may be combined with penile lengthening or lengthening and widening as described earlier in this specification or it may be performed alone. It should also be noted that the artificial erection device can be put in by the classic infrapubic or penoscrotal 0 technique. If the latter is used it will be necessary to perform the penile lengthening by dividing the suspensory ligament having approached it by a vertical (or other) suprapubic incision.

Once the suspensory ligament of the penis and the deep stay sutures have been inserted as described above then the artificial erection device is inserted as per the classical description 5 of the operation via the infrapubic or penoscrotal route as described widely in the general urological and surgical literature. Since additional length in the corpora cavernosa will be achieved by the technique of corporal division which is described hereinafter, the length of the corporal cylinder chosen for the artificial erection device should be 1cm or longer than that already measured for the insertion of that device. If the device has previously been inserted at 0 a previous operation then it will be necessary to reopen the corporal cylinder and either attach a further 1cm rear tip extender or put in the same number of rear tip extenders as put in at the previous operation and add a 1cm longer cylinder which must be new or some combination of those two possible techniques.

Once the artificial erection device is in place the penis is degloved, the artificial 25 erection device fully inflated and the dorsal neurovascular bundle of the penis on either side of the midline dissected free from an area approximately 2cm proximal to the coronal groove. This dissection is carried proximally and distally for 1cm so that the entire area of mobilisation is at least 2cm long. At the midpoint of this dissection the underlying corpus cavemosum on either side is incised and that incision is carried around medially in the 30 midline or laterally around to the junction with the corpus spongiosum. This latter structure is then carefully dissected away from the corpus cavemosum so that it is separated intact over an area of approximately 1cm. The division of the corpus cavemosum is then completed.

The artificial erection device is then fully inflated and maximum separation of the corpus 21 2016273950 15 Dec 2016 cavernosa is achieved. At this stage a dermal graft taken from the original site of dermal fat graft donor area is stripped of its fat and sutured in the circumferential manner to the free margins of the corpus cavonosum using a continuous non-absorbable suture such as 20 Gortex. When the wall of the corpus cavemosum is quite thin and when widening of the 5 shaft of the penis is also being simultaneously achieved using a dermal fat graft a separate dermal graft to fill this defect is not necessary and the deep layers of the dermal fat graft can be sutured to the free edges of the corpus cavonosum instead. During the suturing process it is both important and more convenient for the artificial erection device to be deflated thereby minimising the risk of perforation of that device with the needle during the suturing process. 0 At this stage the degloved penis is then reduced, the distal penile skin incision is closed with a running absorbable suture, the deep stay sutures in the infrapubic region are tied, the proximal wounds are trimmed and closed in layers and dressings are applied.

If the artificial erection device has been in place for some time it is then inflated and left inflated for 24 hours. Dressings are then applied. If the artificial erection device has been put in 5 at the time of surgery as a new device then it is left deflated and a tight circumferential penile dressing applied.

FENESTRATION TECHNIQUE

In a variation of the above described technique for enhancement in the context of the existence of an artificial erection device the penis can be dismembered utilising the following 0 alternative technique to circumferential division and graft in one place:

The fenestration technique comprises separation of the three corpora along the entire length of the penile shaft external to the perineum.

The corpora cavemoso are then incised from 12 o’clock to 6 o’clock on the right hand side of each corpus; a distance of approximately 1cm (or more or less) between each incision. 25 Then the left hand side of each corpus is incised from 12 o’clock to 6 o’clock midway between two adjacent right hand incisions and this series of alternate incisions is carried the entire length of the penile shaft.

For example, a modification on the above fenestration technique can comprise lateral fenestration only of the corpora cavernosa with or without separation of the three 30 corpora. 2016273950 15 Dec 2016 22

Whilst specific embodiments of the present invention have been described herein above, those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. The invention also includes 5 all of steps, features the compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combination or any two or more of said steps or features.

The present invention is not to be limited in scope by the specific examples described herein, which are which are intended for the purpose of exemplification only. Functionally-0 equivalent products, compositions and methods are clearly within the scope of the invention as described herein.

All publications, patents and patent applications cited herein are hereby incorporated by reference in their entirety.

However, any discussion of documents, acts, materials, devices, articles or the like 5 which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

Throughout this specification the word "comprise" or “include” or “have”, or 0 variations such as "comprises" or "comprising" or “includes” or “including” or “has” or “having”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Claims (79)

1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. A method of widening a penis wherein a dermal fat graft comprising a block of fat and attached dermis is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed Bucks fascia and then reducing the penile skin; the method further including the step of following a post-operative treatment regime.
2. 2. The method as claimed in Claim 1 wherein the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen.
3. 3. A method of widening a penis substantially as herein described.
4. 4. A method of lengthening the penis of a male which includes the steps of placing the suspensory ligament under tension in the inferior direction; dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami; effecting suturing to retain the penis released from the suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled to the released penis, dividing the fundiform ligaments, drawing the skin of the junction site of the scrotum and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position; the method further including the step of following a post operative treatment regime.
5. 5. The method of Claim 4 followed by the insertion of additional sutures through the anterior surface of the symphysis pubis; the sutures also placed through the margins of the pubic skin wound and tied in such a manner as to pull suprapubic skin down infrapubically.
6. 6. The method of Claim 5 wherein the number of the additional sutures inserted is 1 or more.
7. 7. The method of Claim 6 wherein the number of the additional sutures is determined by the width of the symphysis pubis.
8. 8. The method of any of Claims 4 to 7 including the step of dividing the fundiform ligament prior to the step of drawing the skin of the junction site of the scrotum.
9. 9. A method of widening a penis wherein a block of fat and attached dermis (dermal fat graft) is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed Bucks fascia and then reducing the penile skin.
10. 10. A method as claimed in Claim 9 wherein the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen.
11. 11. A method of lengthening and widening a penis, the lengthening using the method as claimed in Claim 4 and the widening using the method as claimed in Claim 1 wherein the dermal fat graft is sutured to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.
12. 12. A method of lengthening the penis of a male substantially as herein described.
13. 13. A method of widening a penis substantially as herein described.
14. 14. A method of lengthening and widening a penis substantially as herein described.
15. 15. A method of enhancement phalloplasty of a human penis in patients who are about to have or already have in place an artificial erection device; the penis having a structure including a first corpus cavernosum, a second corpus cavernosum, a corpus spongiosum, a Buck’s fascia and a dorsal neurovascular bundle; the method including the steps of degloving the penis to expose the Buck’s fascia; freeing the dorsal neurovascular bundle and separating the corpus spongiosum from the inferior surface of both the first and the second corpus cavernosum; dividing the first and second corpus cavernosum circumferentially; the method further including the step of following a post-operative treatment regime.
16. 16. The method as claimed in claim 15 wherein the step of separating the corpus spongiosum from the inferior surface of both the first and the second corpus cavernosum comprises a dissection so as to enable the first and second corpus cavernosum to be elongated without dividing the corpus spongiosum.
17. 17. The method as claimed in claim 15 or claim 16 wherein the artificial erection device comprises a corporal cylinder which is longer than the corporal cylinder presently in place, either where the patient already has an artificial erection device in place or longer than the corporal cylinder which was measured when the corporotomy and dilatation of the corpus was performed earlier in the procedure.
18. 18. A method as claimed in claim 16 wherein the increase in length of the corporal cylinder is of the order of one or more cm.
19. 19. A method as claimed in any one of claims 15 to 18 wherein a gap formed in the first or second corpus cavernosum is filled by suturing in place an inverted dermal graft from which the epidermis has been removed.
20. 20. A method as claimed in claim 19 wherein the dermo epidermal surface is the inner most surface applied to the corporal cavity.
21. 21. A method of enhancement phalloplasty as claimed in any one of claims 15 to 20 wherein widening of the penis is also required and wherein widening is effected by using a dermal fat graft.
22. 22. The method of claim 21 wherein the fat graft is sutured to the exposed Bucks fascia and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavernosum the edges of the graft are sutured to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavernosum without dividing the graft as a separate phenomenon.
23. 23. A method of enhancement phalloplasty as claimed in claim 22 wherein if the patient has a very thickened wall of the first or second corpus cavernosum, a first dermal fat graft is placed into the defect in the Buck’s fascia and then a second dermal fat graft is placed into the defect superficial to the first dermal fat graft.
24. 24. A method of enhancement phalloplasty as claimed in claim 23 wherein if the patient has a very thickened wall of the corpus cavernosum, the gap in the wall of the corpus cavernosum is filled by using a gortex graft, a saphenous or other vein patch, temporalis or other fascia such as the fascia lata or dexon mesh or silastic sheeting or other appropriate material and then the second dermal fat graft is applied.
25. 25. A method as claimed in any one of claims 15 to 24 further including an additional step wherein the degloved penis is reduced and the proximal wounds are trimmed and closed in layers.
26. 26. A method of lengthening and widening a penis, the lengthening using the method as claimed in any one of claims 1 to 25 wherein a block of fat and attached dermis (dermal fat graft) is excised from the patient, the penis is degloved, the dermal fat graft is sutured to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.
27. 27. A method of enhancement phalloplasty substantially as hereinbefore described with reference to the examples of the particular operations given in the specification.
28. 28. A method for penile enlargement further including the step of application of a postoperative treatment regime thereby to maintain outcome of enlargement.
29. 29. A method of penile enlargement further including the step of application of a postoperative treatment regime.
30. 30. The method of claims 28 or 29 wherein penile enlargement comprises one or more of lengthening or widening.
31. 31. The method of any previous claim further including the step of treatment for buried penis condition.
32. 32. The method of any previous claim wherein the post-operative treatment regime comprises application of a drug treatment regime.
33. 33. The method of any previous claim wherein the post-operative treatment regime comprises application of an exercise regime.
34. 34. An exercise regime for application following application of the method of any previous claim.
35. 35. A drug treatment regime for application following application of the method of any one of claims 1 to 33.
36. 36. A method of lengthening the penis of a male, which includes the steps of placing the suspensory ligament under tension in the inferior direction; dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami; the method further including the step of following a post operative treatment regime.
37. 37. The method of claim 36 further including the step of effecting suturing to retain the penis released from the suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled to the released penis, dividing the fundiform ligaments.
38. 38. The method of any one of Claims 36 or 37 including the step of drawing the skin of the junction site of the scrotum and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position.
39. 39. A method of widening a penis wherein the penis is degloved, an acellular matrix graft is sutured to the exposed Bucks fascia and then reducing the penile skin; the method further including the step of following a post-operative treatment regime.
40. 40. A method of widening a penis substantially as herein described.
41. 41. A method of widening a penis wherein the penis is degloved, an acellular matrix graft is sutured to the exposed Bucks fascia and then reducing the penile skin.
42. 42. A method of lengthening and widening a penis, the lengthening using the method as claimed in Claim 4 and the widening using the method as claimed in Claim 41 wherein the acellular matrix graft is sutured to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.
43. 43. A method as claimed in any one of claims 15 to 18 wherein a gap formed in the first or second corpus cavemosum is filled by suturing in place an acellular matrix graft.
44. 44. A method of enhancement phalloplasty as claimed in any one of claims 15 to 20 wherein widening of the penis is also required and wherein widening is effected by using an acellular matrix graft.
45. 45. The method of claim 45 wherein the acellular matrix graft is sutured to the exposed Bucks fascia and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavernosum the edges of the graft are sutured to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavemosum without dividing the graft as a separate phenomenon.
46. 46. A method of enhancement phalloplasty as claimed in claim 45 wherein if the patient has a very thickened wall of the first or second corpus cavemosum, a first acellular matrix graft is placed into the defect in the Buck’s fascia and then a second acellular matrix graft is placed into the defect superficial to the first acellular matrix graft.
47. 47. A method of enhancement phalloplasty as claimed in claim 46 wherein if the patient has a very thickened wall of the corpus cavemosum, the gap in the wall of the corpus cavemosum is filled by using a gortex graft, a saphenous or other vein patch, temporalis or other fascia such as the fascia lata or dexon mesh or silastic sheeting or other appropriate material and then the second acellular matrix graft is applied.
48. 48. A drug treatment regime for application following application of the method of any one of claims 39 to 47.
49. 49. A method of lengthening and widening the penis of a male patient, said method including: placing the suspensory ligament of the penis under tension in the inferior direction; dividing the suspensory ligament against the body of the symphysis pubis down to the inferior pubic arch and along the inferior surface of both the right and left conjoined inferior pubic rami; and suturing an acellular matrix graft to the exposed Bucks fascia.
50. 50. The method of claim 49, further including: effecting suturing to retain the penis released from the suspensory ligament in an inferior position by coapting the proximal medial attachments of the right and left gracilus muscle together cephaled to the released penis; and dividing the fundiform ligaments of the penis.
51. 51. The method of claim 49 or 50, including drawing the skin of the junction site of the scrotum and the perineum mediosuperiorally so as to attach it to the symphysis pubis thereby pushing the skin adjacent thereto along the newly exposed shaft of the penis and suturing this to retain this position.
52. 52. The method of any one of claims 49 to 51, further including: inserting additional sutures through the anterior surface of the symphysis pubis, and placing said sutures through the margins of the pubic skin wound; and tying said sutures in a manner sufficient as to pull a corporal cylinder skin down infrapubically.
53. 53. The method of claim 54, wherein the number of said additional sutures inserted is 1 or more.
54. 54. The method of claim 52 or claim 53, wherein the number of said additional sutures is determined by the width of the symphysis pubis.
55. 55. The method of any one of claims 49 to 54, including dividing the fundiform ligament prior to drawing the skin of the junction site of the scrotum.
56. 56. The method of any one of claims 49 to 55, including suturing the acellular matrix graft to the exposed Bucks fascia prior to tying the sutures which maintain the lengthening of the penis.
57. 57. The method of any one of claims 49 to 56, including: degloving the penis; and suturing the acellular matrix graft to the exposed Bucks fascia.
58. 58. The method according to claim 57, including degloving the penis, suturing the acellular matrix graft to the exposed Bucks fascia and then reducing the penile skin.
59. 59. The method of any one of claims 49 to 58, wherein said method is performed in a patients who is about to have or already has in place an artificial erection device, wherein said penis having a structure including a first corpus cavernosum, a second corpus cavemosum, a corpus spongiosum, a Buck’s fascia and a dorsal neurovascular bundle, and wherein said method includes: degloving the penis to expose the Buck’s fascia; freeing the dorsal neurovascular bundle and separating the corpus spongiosum from the inferior surface of both said first and said second corpus cavernosum; and dividing said first and second corpus cavernosum circumferentially.
60. 60. The method of claim 59, wherein the step of separating the corpus spongiosum from the inferior surface of both said first and said second corpus cavernosum comprises a dissection so as to enable the first and second corpus cavemosum to be elongated without dividing the corpus spongiosum.
61. 61. The method of claim 59 or claim 60, wherein said method is performed in a patient who already has in place an artificial erection device and said artificial erection device comprises a corporal cylinder; and wherein a corporal cylinder to be used is longer than the corporal cylinder presently in place, either where the patient already has an artificial erection device in place or longer than a corporal cylinder which was measured when a corporotomy and dilatation of the corpus was performed earlier in the procedure.
62. 62. The method of claim 61, wherein the increase in length of the corporal cylinder is of the order of one or more cm.
63. 63. The method of any one of claims 59 to 62, including filling a gap formed in the first or second corpus cavernosum by suturing in place an acellular matrix graft.
64. 64. The method of any one of claims 59 to 63, including: suturing the acellular matrix graft to the exposed Bucks fascia, and when the graft reaches a defect in the Buck’s fascia corresponding to the division of the first or second corpus cavernosum, suturing the edges of the graft to the Buck’s fascia circumferentially and to a distal portion of the first or second corpus cavernosum without dividing the graft as a separate phenomenon.
65. 65. The method of claim 64, wherein when the patient has a thickened wall of the first or second corpus cavernosum, said method includes placing a first acellular matrix graft into the defect in the Buck’s fascia and then placing a second acellular matrix graft into the defect superficial to said first acellular matrix graft.
66. 66. The method of claim 65, wherein when the patient has a thickened wall of the corpus cavernosum, said method includes: filling the gap in the wall of the corpus cavernosum using a gortex graft or a saphenous vein patch or a non-saphenous vein patch or a temporalis fascia or fascia lata or dexon mesh or silastic sheeting; and then applying said second acellular matrix graft.
67. 67. The method according to any one of claims 59 to 66, further including reducing the degloved penis, trimming the proximal wounds and closing the proximal wounds in layers.
68. 68. The method according to any one of claims 49 to 67, wherein the acellular matrix graft comprises acellular cadaveric dermal tissue.
69. 69. The method according to any one of claims 49 to 68, wherein the acellular matrix graft comprises acellular dermal matrix tissue selected from bovine pericardium, human dermis, porcine dermis, and small intestinal submucosa.
70. 70. The method according to any one of claims 49 to 69, further including performing: a treatment for buried penis condition; and/or a post-operative treatment regime; and/or post-operative penile scar stretching exercises.
71. 71. The method of any one of claims 1 to 70, including performing post-operative penile scar stretching exercises, wherein said performing post-operative penile scar stretching exercises comprises performing one or more exercises selected from: (a) an exercise wherein the patient stands with his right leg flexed to about 90 degrees at the right hip joint and his right foot is resting on an object such that his right knee is also at a right angle, and wherein said exercise comprises the patient passing the patient’s right hand around, under and inside the patient’s right thigh, grasping the glans of the penis using the index finger and thumb of the patient’s right hand, and pulling the grasped glans of the penis downwardly and backwardly so that the penis is pulled down and back between the patient’s testicles and back towards the patient’s anus; and (b) an exercise wherein the patient stands with his left leg flexed to about 90 degrees at the left hip joint and his left foot is resting on an object such that his left knee is also at a left angle, and wherein said exercise comprises the patient passing the patient’s left hand around, under and inside the patient’s left thigh, grasping the glans of the penis using the index finger and thumb of the patient’s left hand, and pulling the grasped glans of the penis downwardly and backwardly so that the penis is pulled down and back between the patient’s testicles and back towards the patient’s anus.
72. 72. The method of claim 71, wherein performing post-operative penile scar stretching exercises comprises: performing exercise (a) wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of at least about 20 seconds, and/or performing exercise (b) wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of at least about 20 seconds.
73. 73. The method of claim 71 or claim 72, comprises performing both post-operative penile scar stretching exercises (a) and (b), wherein exercise (a) is performed at least five times and exercise (b) is performed at least five times, optionally wherein the patient rests for about one second between consecutive times where each of said exercise (a) or (b) is performed.
74. 74. The method of any one of claims 71 to 73, comprising performing by the patient the following steps: (i) performing exercise (a) five times wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of about 20 seconds each time said exercise (a) is performed; (ii) performing exercise (b) five times wherein pulling the grasped glans of the penis downwardly and backwardly is performed by the patient for a period of about 20 seconds each time said exercise (b) is performed; and (iii) repeating steps (i) and (ii), and wherein said method comprising the patient performing steps (i) to (iii) three times per day, optionally wherein the patient performs steps (i) to (iiii) during the morning upon getting out of bed and then performs steps (i) to (iii) in the afternoon and/or evening and then performs steps (i) to (iii) prior to going to bed at night.
75. 75. The method of any one of claims 49 to 74, including administering to the patient a postoperative drug treatment regime to (a) control or prevent penile wound infection, and/or (b) suppress penile erection, and/or (c) prevent or reduce penile tissue swelling.
76. 76. The method of claim 75, wherein administering to the patient a post-operative drug treatment regime comprises administering to the patient one or more drugs selected from: (i) cephalexin monohydrate; (ii) a combination of amoxycillin trihydrate and clavulanic acid; (iii) alprazolam; (iv) fluconazole; (v) ketoconazole; (vi) a combination of paracetamol, codeine and doxylamine succinate; and (vii) prednisone.
77. 77. The method of claim 76, wherein the method comprises administering to the patient orally: (i) cephalexin monohydrate at a dosage of about 500mg, three times a day for 14 days; (ii) a combination of amoxycillin trihydrate and clavulanic acid at a dosage of about 875mg of amoxycillin and about 125 mg of clavulanic acid, twice a day for 14 days; (iii) alprazolam at a dosage between about 0.5 mg to about 1.0 mg, three times a day for 14 days; (iv) fluconazole at a dosage of between about 100 mg to 400mg, two to three times a day for at least 14 days or Ketoconazole at a dosage of about 400mg three times a day for 14 days; (v) a combination of paracetamol, codeine phosphate and doxylamine succinate at a dosage of about 900 mg of paracetamol, about 60mg of codeine phosphate and about lOmg of doxylamine succinate once a night for 14 nights; and/or (vi) prednisone at a dosage of about lOmg three times a day for five days, followed by about lOmg twice a day for three days, followed by about 5mg twice a day for two days followed by 5mg once a day for two days.
78. 78. The method of any one of claims 75 to 77, comprising administering to the patient fluconazole.
79. 79. The method of any one of claims 75 to 78, comprising administering to the patient postoperatively: (i) cephalexin monohydrate; (ii) a combination of amoxycillin trihydrate and clavulanic acid; (iii) alprazolam; (iv) fluconazole; (v) a combination of paracetamol, codeine phosphate and doxylamine succinate; and (vi) prednisone.