AU2018203711A1

AU2018203711A1 - Improved Phalloplasty Method

Info

Publication number: AU2018203711A1
Application number: AU2018203711A
Authority: AU
Inventors: Colin Campbell Marshall Moore
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-04-03
Filing date: 2018-05-25
Publication date: 2018-06-14
Also published as: AU2018201478A1; AU2016273949A1; AU2016273949B2; AU2017201637A1; AU2016273950A1

Abstract

A method of enlarging a penis of a human subject, comprising administering to the subject by one or more intra-dermal injection(s) an amount of a dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the glans and/or shaft of the penis. Methods of lengthening and widening of penis of the human subject are also disclosed. {1SIC" 0u~ ( ~o COT~C VcUA O O~~vvvo~~7 ( V-iV' c~~

Description

IMPROVEMENTS IN PHALLOPLASTY FIELD OF THE INVENTION

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

BACKGROUND OF THE INVENTION

There are several reasons for persons seeking or requiring operations of this type. One reason is for persons born 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 difficult for them.

Another reason 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.

Accordingly, there remains a need in the art for methods of enhancement phalloplasty which provide satisfactory results and which are safe procedures and which result in lengthening and/or widening the penis in both the flaccid and erect states.

The applicant has previously disclosed some surgical procedures in earlier filed patent applications including Australian Patent Applications 28601/97, 53864/98 and 79900/98. However these applications are for a base surgical procedure and may employ dermal fat grafts and/or acellular grafts to widen and/or lengthen the human penis.

However there are only a handful of effective methods of penile widening and/or lengthening which involve less invasive procedures.

SUMMARY OF INVENTION 1. General

In the work leading to the present invention, the inventor reasoned that available surgical methods used to augment the shape and enlarge the male penis of a human subject may be invasive to the human subject in both procedure and recovery time. Accordingly, the inventor sought to develop methods which are less invasive to the subjects and which can produce reasonably comparable penile enlargement effects as those produced using known surgical penile enlargement methods. Specifically, in the work leading to the present invention, the inventor sought to provide improved methods of enlarging the penis of a human male subject which include administering by intra-dermal and/or sub-cutaneous injection into the penis glans and/or shaft an amount of an injectable filler composition such as an acylamide gel, preferably followed by sculpting the injected filler composition to a deshed shape, to thereby enlarge the penis of the subject. The inventor considers that such methods may be less invasive to patients, and patient recovery following injection of filler composition may be shorter in duration and therefore less disruptive to the subject’s day-to-day routine compared with known surgical method of penile augmentation. The inventor has also reasoned that, if desired, the methods of the present invention utilizing an injectable filler composition e.g., administered intra-dermally or subcutaneously may be practiced along-side surgical methods of penile enlargement such as the inventor’s methods of penile shaft widening which involve surgically placing a dermal fat graft and/or acellular matrix onto the Buck’s fascia tissue layer of the shaft.

Accordingly, in one example, the present invention seeks to provide improved methods for enlarging the penis of a human male subject which include administering into the penis glans and/or shaft via an intra-dermal or sub-cutaneous injection an amount of injectable filler composition such as a permanent filler composition (e.g., an acylamide gel), a semi-permanent filler composition and/or a temporary filler composition, and preferably followed by sculpting the filler composition once injected to a desired shape. 2. Specific examples of the invention

The scope of the invention will be apparent from the claims as filed with the application that follow the examples. The claims as filed with the application are hereby incorporated into the description. The scope of the invention will also be from the following description of specific embodiments, aspects and examples and/or detailed description of preferred embodiments and examples.

Accordingly, in a first broad aspect, there is provided a method of enlarging a penis of a human subject. The method comprises administering to the subject by one or more intra-dermal injection(s) an amount of a dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the glans and/or shaft of the penis.

In one example, the method comprises administering to the subject by one or more intra-dermal injection(s) an amount of the dermal filler composition into the dermal layer of the glans of the penis to thereby widen and/or lengthen the glans penis. Preferably, the dermal filler composition is a temporary filler composition such as a filler composition that comprises biodegradable and/or resorbable material selected from the group consisting of collagen, hyaluronic acid, cultured fibroblasts (e.g., cultured human or bovine fibroblasts), human fascia autograph, ascorbic acid 2-glucoside (AA2G) covalently conjugated to crosslinked hyaluronic acid via 1,4-butanediol diglycidyl ether (BDDE), and combinations thereof. Alsd preferably, the dermal filler composition is a semi-permanent filler composition such as biodegradable and/or resorbable material selected from the group consisting of polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof.

In another example, the method comprises administering to the subject by one or more intra-dermal injection(s) an amount of the dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the shaft of the penis to thereby widen the penis shaft. For example, the dermal filler composition is a temporary filler composition or a semi-permanent filler composition. Preferably, the temporary filler composition may comprises biodegradable and/or resorbable material selected from the group consisting of collagen, hyaluronic acid, cultured fibroblasts (e.g., cultured human or bovine fibroblasts), human fascia autograph, ascorbic acid 2-glucoside (AA2G) covalently conjugated to crosslinked hyaluronic acid via 1,4-butanediol diglycidyl ether (BDDE), and combinations thereof. Alternatively, or in addition, the semi-permanent filler composition may comprise biodegradable and/or resorbable material selected from the group consisting of polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof.

In one example, the method according to this aspect comprises administering the amount of the temporary filler to the penis glans and/or penis shaft of the subject by multiple intra-dermal injections.

In one example, the method according to this aspect further comprises sculpting the injected dermal filler composition in the subject’s penis to a desired shape.

In one example, the method comprises performing said administration of the amount of the dermal filler composition into the penis glans and/or penis shaft under local anesthetic of the subject’s penis. In another example, the method comprises performing the administration of the dermal filler composition into the penis glans and/or penis shaft under general anesthetic of the human subject.

In one example, the method is performed under sterile conditions e.g., in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.

It will be understood that the term “certified” when used herein to refer to a medical facility or a hospital, a medical professional such as a surgeon or another medical practitioner, will be understood to mean that the medical facility and/or hospital and/or medical professional such as a surgeon or another medical practitioner has been accredited by a government approved national or international accreditation organization that determines compliance with medical conditions to perform augmentation of a human penis e.g., using filler compositions, under sterile conditions.

In yet another example of a method according to the first aspect, the method further comprises administering to the subject a local infra-pubic nerve blocker to thereby block the dorsal nerves of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject. In one example the nerve blocker is an analgesic.

In yet another example, penis enlargement following administration of the temporary filler composition into the glans penis and/or shaft is maintained for at least 6 to 24 months post said administration.

In one example, the administration of the temporary filler composition into the penis glans and/or glans shaft of the subject is repeated at least about every 1 to 3 years.

In one example, the method comprises administering into the penis glans and/or penis shaft a total amount from about 1 ml to about 15 ml, preferably about 3 ml to about 10 ml, and more preferably about 4 ml to about 10 ml. Alternatively, the method comprises administering into the penis glans and/or penis shaft a total amount of about 1 ml or about 2 ml or about 3 ml or about 4 ml or about 5 ml or about 6 ml or about 7 ml or about 8 ml or about 9 ml or about 10 ml or about 11 ml or about 12 ml or about 13 ml or about 14 ml or about 15 ml.

In one example, the method comprises administering the dermal filler composition into the penis glans and/or penis shaft by multiple intra-dermal injections, wherein each injection delivers an amount of about 0.2 ml to about 2 ml, preferably 0.5 ml to about 1 ml to the penis glans and/or shaft. Alternatively, each injection delivers an amount of about 0.2 ml or about 0.5 ml or about 1 ml or about 1.5 ml or about 2 ml to the penis glans and/or shaft.

Accordingly, in a second broad aspect, there is provided a method of enlarging a penis of a human subject. The method comprises administering to the subject by one or more subcutaneous injection(s) an amount of a semi-permanent or permanent filler composition into the glans of the penis, to thereby widen and/or lengthen said glans of the penis.

In one example, the glans of the penis comprises a spongy region of the glans, a corona of the glans, and a neck region of the glans located behind the corona, and wherein said method comprises administering by one or more sub-cutaneous injection(s) the amount of a semi-permanent or permanent filler composition into the spongy region and/or the corona of the glans. In one example, the method comprises administering the semi-peimanent or permanent filler composition into the spongy region of the glans. Alternatively, or in addition, the method comprises administering the semi-permanent or permanent filler composition into the corona of the glans.

In another example, the method comprises administering the amount of the semipermanent or permanent filler composition into the spongy region of the glans of the penis by multiple sub-cutaneous injections advancing progressively in a fan-like manner transversely along the arcuate circumference of the glans of the penis, wherein each injection delivers an amount of said filler composition commencing at the tip of the glans and progressing longitudinally from said tip to or near the corona of the glans. In one such example, for each one of the multiple injections the semi-permanent or permanent filler composition is administered into the spongy region of the glans by performing a process comprising (i) inserting subcutaneously a needle into the spongy region of the glans near at the coronal sulcus or groove, (ii) advancing the needle inside the spongy region of the glans from the point of insertion of the needle into the glans and up to the tip of the glans near the urethra, and (iii) gradually withdrawing the needle and, at the same time, injecting the semi-permanent or permanent filler composition into said spongy region so as to progressively deliver said filler composition longitudinally from said tip of the glans to said corona region, without also injecting the semi-permanent or permanent filler composition into the dermal layer of the glans.

In one example, the method according to this second aspect further comprises sculpting the injected semi-permanent or permanent filler composition in the subject’s penis glans to a desired shape.

Preferably, the semi-permanent filler composition comprises biodegradable and/or resorbable material selected from the group consisting of polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof. Alternatively, or in addition, the permanent filler composition comprises a non-biodegradable and/or nonresorbable material selected from the group consisting of polyacrylamide gel, medical grade silicone, polymethylmethacrylate, polytetrafluoroethylene and combinations thereof. For example, the medical grade silicone is liquid silicone.

In another example, the method comprises performing said administration of the amount of the semi-permanent or permanent filler composition into the glans of the penis under general anesthetic of the human subject.

In yet another example, the method is performed under sterile conditions e.g., under sterile conditions in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.

In yet another example, the method further comprises administering to the subject local infra-pubic nerve blocker to thereby block dorsal nerve of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject. In one example the nerve blocker is an analgesic.

In one example, the widening and/or lengthening the glans of the penis following administration of the semi-permanent filler composition is maintained for at least about 6 months to 3 years, preferably at least about 2 to 3 years at minimum. Alternatively, the widening and/or lengthening the glans of the penis following administration of the semipermanent filler composition is maintained for at least about 20 to 24 months post said administration. For example, the administration of the semi-permanent filler composition into the glans penis of the subject is repeated at least about every 1 to 3 years.

In another example, the widening and/or lengthening the glans of the penis following administration of the permanent filler composition is maintained for at least about 3 years, preferably for at least about 6 years, and more preferably for at least about 9 years post said administration.

In one example, the method comprises administering into the glans of the penis a total amount from about 1 ml to about 15 ml, preferably about 3 ml to about 10 ml, and more preferably about 4 ml to about 10 ml. Alternatively, the method comprises administering into the penis glans a total amount of about 1 ml or about 2 ml or about 3 ml or about 4 ml or about 5 ml or about 6 ml or about 7 ml or about 8 ml or about 9 ml or about 10 ml or about 11 ml or about 12 ml or about 13 ml or about 14 ml or about 15 ml.

In one example, the method comprises administering the semi-permanent or permanent filler composition to the penis glans by multiple sub-cutaneous injections, wherein each one of the injections delivers an amount of about 0.2 ml to about 2 ml, preferably 0.5 ml to about 1 ml to the penis glans and/or shaft. Alternatively, each injection delivers an amount of about 0.2 ml or about 0.5 ml or about 1 ml or about 1.5 ml or about 2 ml to the penis glans and/or shaft.

Preferably the method according to the first aspect and the method according to the second aspect as described herein above are performed in combination. For example, the method according to the first aspect described herein above further comprises performing the method according to the second aspect described herein above. Alternatively, the method of the second aspect further comprises performing the method according to the first aspect as described herein above.

Accordingly, in a third broad aspect, there is provided a method of enlarging the shaft of a penis of a human subject, comprising administering by sub-cutaneously injection onto the Buck’s fascia tissue layer of the shaft of the penis an amount of an injectable semi-permanent or permanent filler composition, to thereby widen said penis shaft.

In one example, the amount of the injectable semi-permanent or permanent filler composition is administered sub-cutaneously onto the Buck’s fascia tissue layer along the entire length of the penis shaft.

In another example, the human subject has previously undergone penile widening procedure wherein a block of dermal fat graft and/or acellular matrix has been previously placed in situ on the Buck’s fascia tissue of the penis of said subject, and wherein said method comprises administering sub-cutaneously the amount of the semi-permanent or permanent filler composition on the Buck’s fascia tissue layer superficial to said previously placed in situ block of dermal fat graft and/or acellular matrix. For example, the human subject has previously undergone penile widening procedure wherein a block of dermal fat graft and/or acellular matrix has been previously placed in situ on the Buck’s fascia tissue of the penis of said subject by performing a process comprising: (i) degloving the penis to expose the Buck’s fascia tissue layer of the penis; (ii) suturing to the exposed Buck’s fascia tissue said block of dermal fat graft and/or acellular matrix; and then (iii) reducing the penile skin.

In one example, the method comprises administering onto the Buck’s fascia tissue layer of the shaft of the penis the amount of the injectable semi-permanent or permanent filler composition by multiple trans-cutaneous injections.

In one example, administering onto the Buck’s fascia tissue layer of the shaft of the penis the amount of an injectable semi-permanent or permanent filler composition, comprises the steps of (i) making a stab incision in the skin fold at the peno-pubic area of the penis shaft, (ii) inserting sub-cutaneously through said stab incision into the penis shaft an injection cannula, (iii) advancing said injection cannula sub-cutaneously along the length of said penis shaft up to the corona of the penis glans, (iv) withdrawing the injection cannula gradually, while at the same time, injecting onto the Buck’s fascia layer of the shaft said semi-permanent or permanent filler composition, and (v) optionally, repeating steps (i) to (iv). Preferably, the method comprises serially repeating steps (i) to (iv) to serially longitudinally administer the semi-permanent or permanent filler composition onto the Buck’s fascia tissue of the penis shaft at least until the subcutaneous area of the shaft of the penis located above the right and left corpora cavernosa regions of the penile erectile tissue is uniformly filled with the semipermanent or permanent filler composition along the dorsal circumferential length of said penis shaft. For example, the method comprising serially repeating steps (i) to (iv) to longitudinally serially administer the semi-permanent or permanent filler composition onto the Buck’s fascia tissue of the penis until the subcutaneous area of the penis shaft is uniformly filled with the semi-permanent or permanent filler composition along the dorsal circumferential length of said shaft at least from the corona of the penis glans between the corpus spongiosum region and the right corpora cavernosa region of the penile erectile tissue and around the dorsal circumference of the penis to the corona of the penis glans between the corpus spongiosum region and the left corpora cavernosa region of the penile erectile tissue.

In one example, step (iv) comprises serially injecting onto the Buck’s fascia layer of the penis shaft an amount of about 0.5 ml to about 2.0 ml, preferably about 0.5 ml to about 1.5 ml of the semi-permanent or permanent filler composition at a time, while withdrawing the injection cannula. Alternatively, step (iv) comprises serially injecting onto the Buck’s fascia layer of the penis shaft an amount of about 0.5 ml or about 0.6 ml or about 0.7 ml or about 0.8 ml or about 0.9 ml or about 1.0 ml or about 1.1 ml or about 1.2 ml or about 1.3 ml or about 1.4 ml or about 1.5 ml or about 1.6 ml or about 1.7 ml or about 1.8 ml or about 1.9ml or about 2.0 ml of the semi-permanent or permanent filler composition at a time, while withdrawing the injection cannula.

In one example, the injection cannula is a spatulate cutting edge injection cannula.

In one example, the method comprises administering the semi-permanent or permanent filler composition sub-subcutaneously onto Buck’s fascia tissue layer located above the right and left corpora cavernosa regions of the penile erectile tissue.

In one example, the method according to this third aspect does not comprise administering the semi-permanent or permanent filler composition onto the Buck’s fascia tissue layer located above the corpus spongiosum region of the penile erectile tissue.

In yet another example, the method further comprising sculpting the injected filler composition in the subject’s penis to a desired shape.

Preferably, the injectable semi-permanent filler composition comprises biodegradable and/or resorbable material selected from the group consisting of polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof. Alternatively, or in addition, the injectable permanent filler composition comprises a non-biodegradable and/or non-resorbable material selected from the group consisting of polyacrylamide gel, medical grade silicone (e.g., liquid silicone), polymethylmethacrylate, polytetrafluoroethylene and combinations thereof.

Preferably, the injectable filler composition is a permanent filler composition such as one comprising polyacrylamide gel.

In one example, the method is performed under general anesthetic of the human subject. In yet another example, the method is performed under sterile conditions e.g.,in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.

In yet another example, the method further comprises administering to the subject a local infra-pubic nerve blocker to thereby block dorsal nerve of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject. In one example the nerve blocker is an analgesic.

In one example, widening of the shaft following administration of the semi-permanent filler composition is maintained for at about 6 months to 3 years, preferably for at least about 2 to 3 years at minimum. More preferably, widening of the shaft following administration of the semi-permanent filler composition is maintained for at least about 20 to 24 months post said administration, For example, the administration of the semi-permanent filler composition into the glans penis of the subject is repeated at least about every 1 to 3 years.

In another example, widening of the shaft following administration of the permanent filler composition is maintained for at least about 3 years, preferably for at least about 6 years, and more preferably for at least about 9 years post said administration.

In one example, the method according to this third aspect comprises administering onto the Buck’s fascia of the shaft of the penis a total amount from about 1 ml to about 150 ml, preferably about 50 ml to about 100 ml, and more preferably about 40 ml to about 80 ml. Alternatively, the method comprises administering into the penis glans a total amount of about 10 ml or about 20 ml or about 30 ml or about 40 ml or about 50 ml or about 60 ml or about 70 ml or about 80 ml or about 90 ml or about 100 ml or about 110 ml or about 120 ml or about 130 ml or about 140 ml or about 150 ml.

Preferably the method according to this third aspect as described herein above is performed in combination with the method according to the first aspect and/or the second aspect as described herein above. For example, the method according to this third aspect described herein above further comprises performing the method according to first aspect and/or the method according to the second aspect described herein above. Alternatively, the method of the first aspect or the method of the second aspect further comprises performing the method according to the third aspect as described herein above.

In one example, the method according to any aspect hereof is performed under conditions where the penis is in a flaccid non-erect state. Alternatively, the method according to any aspect hereof is performed under conditions where the penis is in erect state.

In yet another example, the method according any aspect hereof, comprises manually sculpting the injected filler composition in the subject’s penis to a desired shape.

Accordingly, in another broad aspect of the invention there is provided a method for penile enlargement farther including the step of application of a post-operative treatment regime. It will be understood that the method according to this aspect can be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

Accordingly, in another broad aspect 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. It will be understood that the method according to this aspect can be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

Accordingly, in yet another aspect 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

Bucks fascia and then reducing the penile skin; the method further including the step of following a post-operative treatment regime. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

Preferably the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen.

Accordingly, in yet another broad aspect 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 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 method further including the step of following a post-operative treatment regime.

It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

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.

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 aspect of the invention there is provided 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. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

Preferably 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 aspect 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 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. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

Preferably 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.

Preferably 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.

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

Preferably a gap formed in the first or second corpus cavernosum 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 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 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.

Preferably 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.

Preferably 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.

Preferably the method further including an additional step wherein the degloved penis is reduced and the proximal wounds are trimmed and closed in layers.

Accordingly, in yet another broad aspect 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. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

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

Preferably further including the step of treatment for buried penis condition.

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 aspect of the invention there is provided an exercise regime for application following application of the above described method.

Accordingly, in yet a further broad aspect 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 aspect of the invention there is provided a method of lengthening and widening a penis, the lengthening using the method as described above 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 lengtihening of the penis.

Accordingly, in yet another broad asepct 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; the method further including the step of following a with post operative treatment regime.

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 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 aspect 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; the method further including the step of following with a post-operative treatment regime. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

In yet another broad aspect 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. It will be understood that the method according to this aspect can also be performed in combination with any one or more of the methods according to the first, second and third aspects described herein above.

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 cavernosum is filled by suturing in place an acellular matrix graft.

Preferably widening of the penis is also required and wherein widening is effected by 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 dividing the graft as a separate phenomenon.

Preferably if the patient has a very thickened wall of the first or second corpus cavernosum, 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.

Preferably 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 acellular matrix graft is applied.

Accordingly, in one broad aspect of the invention there is provided a method of 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 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 tissue swelling.

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 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 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.

Preferably, the method includes dividing the fundiform ligament prior to drawing the skin of the junction site of the scrotum.

Preferably, the method includes suturing a dermal fat graft to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.

In one example, the dermal fat graft has been harvested from either buttocks, lower back or lower abdomen.

In one example, the method is performed in patients who are 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 cavernosum, a coipus spongiosum, a Buck’s fascia and a dorsal neurovascular bundle. According to this example, the 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.

Preferably, the step of separating the corpus spongiosum from the inferior surface of both said first and said second coipus cavernosum comprises a dissection so as to enable the first and second corpus cavernosum 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 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 cavernosum by suturing in place an inverted dermal graft from which epidermis has been removed.

Preferably, suturing in place the inverted dermal graft from which epidermis has been removed comprises applying to a corporal cavity of said penis a dermo epidermal surface of said inverted dermal graft, wherein said dermo epidermal surface is the innermost surface of said dermal graft applied to a corporal cavity of said penis.

For example, the method may include suturing a dermal fat 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 or step.

Optionally, when the patient has a thickened wall of the first or second corpus cavernosum, the method includes placing a first dermal fat graft into the defect in the Buck’s fascia and then placing a second dermal fat graft into the defect superficial to said first dermal fat graft. For example, when the patient has a thickened wall of the corpus cavernosum, the method may include 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 dermal fat graft.

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.

In another example, the method according to this broad aspect includes excising from the patient a dermal fat graft comprising a block of fat and attached dermis; degloving the penis; and suturing the dermal fat graft to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.

In yet another example of a method according to this broad aspect, the step of administering to the patient a post-operative drag 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 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 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 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 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 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 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.

In yet another example, the method according to this broad aspect further includes performing a treatment for buried penis condition.

Alternatively, or in addition, the method according to this broad aspect further includes performing by the patient a post-operative penile 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 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.

Preferably, the method according to this example comprises performing exercise (a) 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, 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.

For example, 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 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 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 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.

Accordingly, in one broad aspect of the invention there is provided a method of 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.

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

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 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.

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 coipus cavernosum, 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 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 cavernosum comprises a dissection so as to enable the first and second coipus cavemosum to be elongated without dividing the corpus spongiosum.

Preferably, the method includes filling a gap formed in the first or second corpus cavernosum 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 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 or step.

Optionally, when the patient has a thickened wall of the first or second corpus cavernosum, 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 coipus cavernosum, the method may include 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.

In one example, the acellular matrix graft employed in the method according to this broad aspect 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 aspect further includes performing a 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 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 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.

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 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 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.

In yet another example of a method according to this broad aspect, 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 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 paracetamol, codeine and doxylamine succinate, and (vii) prednisone..

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. 3. Additional information

Unless the context otherwise or specifically stated to the contrary, integers, steps, or elements of the invention recited herein as singular integers, steps, or elements clearly encompass both singular and forms of the recited integers, steps or elements.

As used herein the term “derived from” shall be taken to indicate that a specified integer may obtained from a particular source albeit not necessarily directly from that source.

Throughout this specification, unless the context requires otherwise, the word or “comprise” or variations such as “comprises” or “comprising” or word “having” or variations thereof such as “has” will be understood to imply the inclusion of a stated step or element or integer or group of steps or elements or integers but not the exclusion of any other step or element or integer or group of elements or integers.

Through this specification, unless specifically stated otherwise or the context requires otherwise, reference to a single step, composition of matter, groups of steps, or compositions of matter shall be taken to encompass one and a plurality (i.e., one or more) of those steps, compositions or matter, groups of steps, or group of compositions of matter. Accordingly, as used herein and in the appended claims, the singular form “a”, “an”, and “the” include plural reference unless the context clearly dictates otherwise.

Each example described herein is to be applied mutatis mutandis to each and every other example unless specifically stated otherwise.

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 all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of 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 intended for the purpose of exemplification only. Functionally-equivalent products, compositions and methods are clearly within the scope of the invention, as described herein.

All publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety. However, publications mentioned herein are cited for the purpose of describing and disclosing the protocols, reagents and materials which are reported in the publications and which might be used in connection with the invention. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention.

BREIF DESCRIPTION OF THE DRAWINGS

Figure 1 is a side section view of the anatomy of the human penis and related structures.

Figure 2 is a further side view pursuant to a procedure in accordance with an embodiment of the present invention,

Figure 3 is a front section view of the anatomy of the human penis and related structures.

Figure 4 is a further front view pursuant to a procedure in accordance with an embodiment of the present invention.

Figure 5 is cross section view through the human penis.

Figure 6 is a further cross section view through the human penis also pursuant to a procedure in accordance with an embodiment of the present invention.

Figure 7 is a further front section view of the anatomy of the human penis pursuant to a procedure in accordance with an embodiment of the present invention.

Figure 8A is an underside view of the human penis and related structures.

Figure 8B is a cross section through shaft portion detailing the anatomy of the human penis of figure 8A.

Figure 9 is a side view of a substantially degloved human penis detailing aspects of its anatomy.

Figure 10 is plane section view of the anatomy of the human penis and related structures.

Figure 11 illustrates a view of an injection cannula for use with embodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

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

In a first of these preferred embodiments, there is provided a method of enlarging a penis of a human subject, comprising administering to the subject by one or more intra-dermal injection(s) an amount of a dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the glans and/or shaft of the penis, to thereby to “bulk up” the glans penis e.g,, by increasing the glans penis traverse diameter and/or increasing the glans penis longitudinal length and/or widening the penis shaft.

In a second of these preferred embodiments, there is provided a method of enlarging a penis of a human subject, comprising administering to the subject by one or more sub-cutaneous injection(s) an amount of a semi-permanent or permanent filler composition into the glans of the penis, to thereby widen and/or lengthen said glans of the penis.

In a third of these preferred embodiments, there is provided a method of enlarging the shaft of a penis of a human subject, comprising administering by sub-cutaneous injection onto the Buck’s fascia tissue layer of the shaft of said penis an amount of an injectable semi-permanent or permanent filler composition, to thereby widen said penis shaft.

In a further preferred embodiment, in addition to the above methods of penile enlargement of glans penis and/or shaft of the human penis using injectable filler composition, further enlargement of the human penis can involve 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 arch (i. e., all of the anteroinferior surface of the pubic symphysis. According to this embodiment 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.

To aid in the full understanding of the invention, the procedures of preferred embodiments are more fully described below:

THE HUMAN PENIS

With reference to the drawings, as used herein the term “penis” as referred to a penis of a human subject will be understood to include the penis shaft and penis glans of a male subject. The” penis shaft” also known as “penis pendent” as used herein refers to the body of the penis attached to and extending from the fascia and the pubic ramus in the peno-pubic area of the penis up to the penis glans. It is bound to the front of the pubic symphysis by fundiform and suspensory ligaments. In other words, the penis shaft or pendent is the flesh external to the subject’s body and extends from the peno-pubic areas up to the glans of the human penis.

The shaft of the human penis comprises an erectile tissue that includes three erectile columns (or erectile tissue regions) being two corpora cavernosa i.e., a right corpora cavernosa and a left corpora cavernosa and a coipus spongiosum, as well as the columns' enveloping fascial layers, nerves, lymphatics, and blood vessels, all covered by skin. More specifically, these three erectile tissue columns or regions runs longitudinally inside the penis shaft from the pubic bones to the penis glans and extend somewhat slightly into the penis glans e.g., roughly up to the corona region of the glans. The two corpora cavernosa erectile tissue regions or columns fill the left and right dorsal regions of the penis shaft. The corpus spongiosum is ventral to the two corpora cavernosa regions.

The dorsal circumferential length of the penile shaft extends longitudinally from the peno-pubic area to the corona of the penis glans, and extends circumferentially between the coipus spongiosum region and the right coipora cavernosa region of the penile erectile tissue and around the dorsal circumference of the penis to the corona of the penis glans between the corpus spongiosum region and the left corpora cavernosa region of the penile erectile tissue.

The two (right and left) corpora cavernosa regions are surrounded by a compliant dense fibrous sheath of connective tissue called the “tunica albuginea” tissue, and a thin layer of areola tissue separates the corpora cavernosa from the tunica albuginea. The tunica albuginea consists of 2 layers, the outer longitudinal and the inner circular. The tunica albuginea becomes thicker ventrally where it forms a ventral groove to accommodate the corpus spongiosum. The tunica albuginea of the corpus spongiosum is considerably thinner (about < 0.5 mm) than that of the corpora cavernosa (about 2 mm). Along the inner aspect of the tunica albuginea, flattened columns or sinusoidal trabeculae composed of fibrous tissue and smooth muscle surround the endothelial-lined sinusoids (cavernous spaces). In addition, a row of structural trabeculae arises near the junction of the 3 corporal bodies and inserts in the walls of the corpora about the midplane of the circumference. The two corpora cavernosa regions communicate freely through an incomplete midline septum which is the region between the right and left corpora cavernosa and is comprised of the tunica albuginea and the thin areola which separates the two corpora cavernosa regions.

The single corpus spongiosum region or column lies in the above-mentioned ventral groove formed by the tunica albuginea between the two corpora cavenorsa and runs longitudinally from the bulb of the penis and into the glans. The urethra is contained within and passes through the corpus spongiosum.

The erectile tissue within the corpora contains arteries, nerves, muscle fibers, and venous sinuses lined with flat endothelial cells, and it fills the space of the corpora cavernosa. A transversely cut surface of the corpora cavernosa looks like a sponge. There is a thin layer of areolar tissue that separates this tissue from the tunica albuginea. Blood flow to the corpora cavernosa is via the paired deep arteries of the penis (cavernosal arteries), which run near the center of each corpora cavernosa.

The corpus spongiosum possesses a much thinner and more elastic tunica albuginea to allow for distention of the coipus spongiosum for passage of the ejaculate through the urethra. The thinner tunica albuginea of the corpus spongiosum also allows the corpus spongiosum to become less rigid during erection. Hence, the distal extension of the corpus spongiosum, which forms the glans penis, covers the tips of the corpora cavernosa to provide a cushioning effect. The urethral meatus is positioned just slightly on the ventral surface at the summit of the glans and is slit-like.

Accordingly, as used herein, the term “glans” or “glans of the penis” of “glans penis” or “penis glans” will be understood to refer to “head” of the human penis which is the sensitive bulbous structure at the distal end of the human penis. As broadly explained above, the glans penis is a cap-shaped expansion of the corpus spongiosum at the end of the penis shaft and is moulded on the rounded ends of the right and left corpora cavernosa regions, extending farther on their upper than their lower surface. At the summit of the glans is the slit-like vertical external urethral orifice. It will be understood that the glans comprises the main “spongy body” or “spongy region” of the glans, the “corona” or “corona tissue” (also known as “rim” region) of the glans, and the “neck” of the glans. The “corona” or “corona tissue” is the ridge of tissue forming a projecting border which is the circumference of the base of the glans overhanging a deep retroglandular sulcus (the coronal sulcus or groove). Behind the coronal sulcus or groove is the neck of the penis. As used herein the term “spongy body” or “spongy region” of the glans refers to the main portion of the glans which does not include the neck and corona of the glans, but which extends circumferentially all around the glans from the corona to the summit of the penis and includes the tip of the glans which contains the slitlike urethral orifice (urinary meatus). The glans is covered with a usually pink dermal moist mucosa membrane epithelium tissue (mucosa). In uncircumcised males, covering the glans is the foreskin (prepuce). The foreskin maintains the mucosa in a moist environment. In circumcised males, the foreskin is surgically removed and the mucosa on the glans is permanently exposed and usually becomes dry. The edge of the glans overhangs the shaft of the penis, forming a rim called the corona.

The three erectile tissue regions of the penis i.e., the two (right and left) corpora cavernosa and the corpus spongiosum, are surrounded and by the Buck’s (or deep penile) fascia, dartos fascia, and dermal (skin) tissue layers. The Buck’s fascia is a tough, elastic fibrous tissue layer immediately adjacent to the tunica albuginea. The Buck’s fascia is continuous with the deep fascia of the muscles covering the crura and bulb of the penis, the ischiocavernosus and bulbospongiosus. The "dartos (or superficial penile) fascia” also referred to herein as the “loose aerolar tissue” layer is the subcutaneous connective tissue of the penis having abundant smooth muscle which is located between the Buck’s fascia and the dermal (skin) tissue layers, and is only loosely attached to the dermal (skin) layer and to the Buck’s fascia. The dartos fascia contains the superficial arteries, veins, and nerves of the penis.

On the dorsal aspect of the corpora cavernosa, the deep dorsal vein and paired dorsal arteries and branches of the dorsal penile nerves are contained within the Buck’s fascia. The Buck’s fascia splits to surround the corpus spongiosum, and it extends into the perineum as the deep fascia of the ischiocavernosus and bulbospongiosus muscles. The Buck’s fascia encloses these muscles and each crus of the corpora cavernosa and the bulb of the corpus spongiosum, adhering these structures to the pubis, ischium, and the urogenital diaphragm.

As used herein the term “dermal layer” or “dermal tissue” or “skin layer” or “skin tissue” of the penis will be understood to refer to the penile dermal (i.e., skin) layer on the penis shaft and penis glans. The penile skin layer is continuous with that of the lower abdominal wall. Distally, the penile skin is confluent with the smooth, hairless skin covering the glans. At the corona of the glans, it is folded on itself to form the prepuce (foreskin), which overlies the glans in uncircumcised males. Accordingly, it will be understood by those skilled in the art that a reference to a “subcutaneous area” of the human penis including a subcutaneous area of the penis shaft and/or glans refers to any area located beneath the penile dermal (or skin) layer including (but not limited to) in the dartos fascia or on the Buck’s fascia layer or the penile shaft and/or glans. In one example, a “subcutaneous area” of the glans includes the corpus spongiosum tissue of the glans. Accordingly, in one example of the penile enlargement methods described herein, a sub-cutaneous injection of a filler composition (such as a semi-permanent or permanent filler composition) in the spongy region of the glans and/or into the corona of the glans includes a sub-cutaneous injection of the filler composition into the corpus spongiosum tissue of the spongy region and/or corona of the glans.

Examples of a descriptive and/or illustrative overview of the anatomical structure and description of the human penis can be publically found on the World Wide Web e.g., at http://emedicine.medscape.com/article/1949325-overview.

The penis is innervated by the pudendal nerve (S2-S4). This nerve eventually divides into the right and left dorsal nerves of the penis that pass under the pubis symphysis to travel just below the Buck fascia to supply the sensory innervation to the penis. Accordingly, use of at least local anesthesia it is generally recommended as preparation in advance of any procedures to augment and/or repair penis e.g., during cosmetic augmentation of the penis and/or repair of cosmetic laceration and/or dorsal slit of the foreskin or circumcision. The use of analgesia (e.g, parenteral analgesia) with or without sedation is generally considered recommended before the application of local penile anesthesia. Analgesic effect can be achieved e.g., by administering to the male subject undergoing penile augmentation by any method of penile enhancement described herein an analgesic effective amount of a local infer-pubic nerve blocker e.g., to block the pudendal nerve and/or the dorsal nerves. In one example, the nerve blocker achieves at least dorsal penile nerve block (DPNB). In one example, the dorsal penile nerve block is achieved by local anesthetic with lidocaine. In one preferred example, the nerve blocker can act to inhibit erection in the subject e.g., by inhibiting sensation in the penis during any penile augmentation procedure described herein. INJECTABLE MATERIALS OR FILLER/S1

Suitable injectable material fillers which may be used for insertion into the glans penis and/or the shaft of the human penis in the methods of penile enlargement described herein include injectable filler compositions employed for permanent correction or augmentation of soft tissue defects or augmentation for cosmetic or non-cosmetic purposes and may be dermal and/or temporary and/or semi-permanent and/or permanent in nature. As used herein the term “dermal filler composition” or variations thereof such as “dermal filler” or dermal filler material” will be understood to refer to any injectable filler composition which suitable for injection into the dermal layer (skin layer) or into the loose areolar tissue layer just beneath the dermal layer of the human penis and can be used to volumes regions of penis to enhance or enlarge the shape of the human penis by bulking-up at least the dermal and/or loose areolar tissue layers of the human penis. It will also be understood that dermal filler composition includes injectable filler compositions which are temporary and/or semipermanent and/or permanent in nature i.e., after their injection into the human penis.

It will also be understood that the term “permanent filler compositions” or variations thereof such as “permanent fillers” refer to those injectable filler compositions which are made of, or include, non-biodegradable and non-resorbable material (i.e., the human body does not resorb the filler or break it down naturally) and, as such, remain in the penis permanently after injection.

It will also be understood that the term “semi-permanent filler compositions” or “semipermanent fillers” and “temporary filler compositions” or “temporary fillers” refer to those injectable compositions which are made of or include biodegradable material and/or resorbable and/or metabolized by the patient e.g., over intermediate (temporary) duration or over long duration (semi-permanent). In general, the full enlargement effect produced by semipermanent filler compositions remains noticeable in the penis for at least 6 months post injection and usually an enlargement effect remains in the penis shaft and/or glans as long as at least 20 to 24 months. In general, the enlargement effect of temporary filler composition remains in the penis shaft and/or glans up to 6 to 18 months post injection e.g., depending on filler material and/or rate that the filler material is metabolized in the patient body. It will be understood that repeated injections at least every 1 to 3 years are required to maintain the enlargement effect when using semi-permanent and/or temporary filler compositions.

Suitable injectable permanent filler compositions include non-resorbable, optionally particle-based and/or inorganic compositions, employed for permanent correction or augmentation of soft tissue defects such as gel materials, medical grade silicone, and other injectable alloplastic implant compositions.

Permanent filler (s)

For example, a suitable permanent filler composition for use in the augmentation methods described herein is an injectable composition of polyacrylamide gel (PAAG). PAAG is a soft, gelatinous, hydrophilic, biocompatible, and non-allergenic product that contains a hydrogel composed of polyacrylamide and water. It is also known by its trade name “interfall”. PAAG has been used as a soft tissue filler material for cosmetic augmentation to augment soft tissue in various parts of the human face and breasts. PAAG is considered a permanent filler, and once injected, generally it cannot be completely removed. The plasticity of PAAG is similar to that of silicone. As PAAG is a hydrophilic content it is well tolerated by human tissue for long periods e.g., up to at least 9 years postoperatively. Suitable injectable PAAG hydrogel compositions are commercially available and can be sources from number of suppliers including, but not limited to, Shandong Biogen (China), NanFeng Medical Science and Technology Development Co., Ltd (China), Merrystone Medicine Science and Technology Development Co. Ltd (China), Matt Pharm.Co,.Ltd (USA), Chemicaltradsarlsro (USA), Beta Chemicals Ltd (USA).

For example, PAAG is injected to the glans penis and/or the penis shaft under sterile conditions with or without prior local anesthetic, by the methods described herein. Generally, about 0.1 ml to about 5 ml of PAAG may be injected to the penis at any one time (i.e., during a single delivery or injection). For example, about 0.5 ml to about 4 ml or about 3ml or about 2 ml or about 1.5 ml or about 1 ml or about 0.5 ml of PAAG is injected to the penis at any one time. More preferably, about 0.01 to about 1 ml or about 1.5 ml is of PAAG is injected to the penis at any one time. For example, a total amount of about 4 ml to about 150 ml of PAAG is injected to a male patient to produce effective enlargement. In one example, a total amount of about 4 ml to about 10 ml, or from about 5 ml to about 10 ml, or about 4 ml, or about 5 ml, or about 6 ml, or about 7 ml, or about 8 ml, or about 9 ml or about 10 ml of the filler composition is injected into the male penis glans to produce an penile enlargement effect in the glans of the penis. In another example, a total amount of about 40ml to about 150 ml, or about 50 ml to about 125 ml, or about 50 ml to about 100 ml, or about 40ml, or about 50 ml, or about 60 ml, or about 70 ml, or about 80 ml, or about 90 ml, or about 100ml of PAAG is injected to a male penis to produce effective enlargement. Preferably, a total amount of about 40ml to about 100 ml of PAAG is injected to shaft of the human penis to produce effective shaft enlargement. Also preferably, a total amount of 4 ml to 10ml PAAG is injected into the glans of the human penis to produce effective widening and/or lengthening of the glans.

Another example of a suitable permanent filler for use in the methods of augmentation of human penis described herein includes an injectable composition of silicone, such as medical grade silicone. As used herein, the term “silicone” or “silicones” shall be understood to refer to polysiloxanes or silicone polymers. These are compositions comprising polymerized siloxane which consists of a backbone chain of alternating silicon atoms and oxygen atoms (.. .-Si-O-Si-O-Si-O-...) with optionally carbon and hydrogen (i.e., organic) side groups attached to the silicon atoms. Silicones falling within the scope of the present invention have in general the chemical formula [RaSiOjn where R is an organic group such as methyl (-CH3), ethyl (-CH2CH3) or phenyl (cyclic group of atoms with the formula 06¾). Also, as used herein, the term “medical grade silicone” or “medial grade silicones” refers to silicones tested for biocompatibility and are appropriate to be used for medical applications as determined e.g., by the United States, Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body and/or by the Australian Therapeutic Goods Administration (TGA).

Previously, injectable silicone products have been used for injection in eye areas and/or as cosmetic treatment for certain types of acne and chicken pox scars, but not for use in human penis augmentation. Once injected into the human penis, the body has no mechanism to metabolize silicone, so the injected silicone material remains in the soft tissue where it is placed. Additional volume for penile shaft and/or glans penis enlargement may be added by the human body’s own healing mechanisms which can form fibrous tissue around the injected medical grade silicone to contribute to producing desired volume enhancement.

Medical grade silicone compositions are commercially available from suppliers such as NuSil Technology based in Carpenteria, California, US. For example, medical grade silicone product suitable for use in the methods of the present invention described herein include liquid silicone, solid silicon particles in suspension, and silicone gel such as polydimethylsiloxane (PDMS).

Preferably, the silicone composition used in the methods described herein is a medical grade liquid silicone injectable composition e.g., commercially available liquid injectable silicone product Silikon 1000® (purified polydimethylsiloxane, Alcon) and/or AdatoSil 5000® (purified polydimethylsiloxane (PDMS), Bausch & Lomb). Both of these exemplified injectable liquid silicone products have been approved by the FDA e.g., for intraocular use. For example, Silikon 1000® is the less viscous of the two products (1,000 cs) and can be injected with either a 27-gauge needle or 25-gauge needle. AdatoSil 5000® has a viscosity of 5,000 cs and can be delivered with a 25-gauge needle. For example a 1 cc, glass Luer-Lok syringe can be used for injections of liquid silicone when performing silicone injections.

Alternatively, or in addition, the silicone composition used in the methods described herein include a solid silicon particles in suspension (e.g., Bioplastique®, which is solid silicone microspheres suspended in a polynivylpyrrolidone vector, by Uroplasty, Inc., 5420 Feltl Road, Minnetonka, Minnesota, US).

Alternatively, or in addition, the silicone composition used in the methods described herein include a silicone gel such as polydimethylsiloxane (PDMS) (e.g., NuSil Technology based in Carpenteria, California, US). In one particular example, a polydimethylsiloxane (silicone elastomer chain) gel with or without radical groups substituted for methyl groups can be used. The following formula (I) is a PDMS or dimethyl silicone elastomer:

[I]

In another example, a silicone gel which consists of a siloxane with one or two phenyl (C6H5) substituted groups (e.g., NuSil Technology based in Carpenteria, California, US). The following formula (II) is the polydimethylsiloxane above with a methyl-phenyl substituted group:

[Π]

The following formula (III) is the polydimethylsiloxane above with a diphenyl substituted group (i.e., poly diphenyl siloxane):

[III]

I

Another example of a permanent filler suitable for use in the methods of augmentation of human penis described herein includes an injectable composition of polymethylmethacrylate (PMMA) having the general formula (CsChHa),,, such as a medical grade injectable PMMA composition. PMMA is a non-degradable material (and thus permanently maintained in vivo) that may be used in cosmetic surgery for soft tissue augmentation e.g., in the form of PMMA microspheres suspended in biological or organic fluid or gel. As the PMMA microspheres are not absorbed by the body, they provide a permanent scaffold into which the person's own soft tissue can grow. Accordingly, in addition to a direct tissue-volume enhancement/augmentation effect produced by the PMMA injected material, further tissue enhancement/augmentation effect may be achieved by the PMMA containing compositions stimulating production of autologous tissue, such as collagen, around the injection site of PMMA. For example, a suitable filler composition for use in the methods described herein includes PMMA microspheres having a diameter of 20-40 pm and suspended in a bovine collagen dispersion e.g., as described in US Pat. No. 5,344,452 issued to Lemperle, the contents of which are incorporated herein by cross-reference in their entirety. In another example, a further suitable filler composition for use in the methods described herein includes the FDA-approved commercially available PMMA composition ArteFill® available from Artes Medical Co. (5870 Pacific Center Boulevard, San Diego, CA 92121, US) or also marketed as Bellafill® available from Suneva Medical, Inc (San Diego, CA 92121, US). The ArteFill®/ Bellafill® product is a gel suspension of 20% of 30-42 pm (in diameter) microspheres of PMMA, 3.5% bovine collogen, and 0.3% lidocaine (N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide; also known as xylocaine and lignocaine). Although the PMMA microspheres themselves are non-degradable, the bovine collagen component may degrade within about 6 months but, as the human recipient tissue grows-in, the initial filling can last for at least 5 or more years. In yet another example, filler compositions suitable for use in the methods described herein include a composition comprising PMMA as a basic polymer and dextran as a carrier as described in US Patent Application Publication No. 2003/0233150 by Bourne at at, (the contents of which are incorporated herein by cross reference in their entirety), and/or compositions comprising PMMA and cross-linked dextran as described in Korean Patent No. 10-0759091 and US Patent No. 9,242,030 by Kang Seon Jo (the contents of each which are incorporated herein by cross reference in their entirety). In yet another example, further filler compositions suitable for use in the methods described herein include a suspension of PMMA microspheres having a diameter of about 32-90 pm and suspended in a gel as a carrier, the gel is a combination of a cellulose polysaccharide such as carboxymethylcellulose (CMC) and an alcohol such as polyvinyl alcohol (PVA) dissolved in water or other suitable solvent, as described in US Patent No. 8,038,721 by Anna Love (the contents of which are incorporated herein by cross reference in their entirety). Another commercially available PMMA containing composition suitable for use in the methods described herein includes the MetaoCrill® product available from Nutricel (city of Guapimirim, Rio de Janeiro, Brazil) which has been approved by the Brazil National Health Surveillance Agency - ANVISA. This Metacrill product is an injectable biologically inert suspension of microspheres of PMMA of 40-60 pm (in diameter) in a chemical colloid composed of carboximethylcelulose. Yet a further commercially available compositions containing PMMA microspheres suitable for use in the methods described herein include the Linnea Safe® product available from Lebon Laboratorio, Porto Alegre, RS, Brazil) and the Biosfera™ product.

Another example of a permanent filler suitable for use in the methods of augmentation of human penis described herein includes an injectable composition of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) being a fluorocarbon solid consisting wholly of carbon and fluorine and having the general formula (C5FF4);;.

Semi-permanent filler (s)

For example, a suitable semi-permanent filler for use in the augmentation methods described herein is an injectable composition of polylactic acid. Polylactic acid is a non-toxic and biodegradable synthetic dermal filler that historically has been used for injection into the face. Polylactic acid stimulates body's own production of collagen so that enlargement effect in the shaft and/or glans may not be observed immediately post injection but may only appear gradually over a period of a few months post injection. In one example, polylactic acid is mixed with water (e.g., sterile water) to reconstitute the polylactic acid prior to administration into the human body. For example, in the methods described herein, a polylactic acid or a reconstituted polylactic acid may injected into the dermal layer and/or into the loose areolar tissue layer beneath the dermal layer of the glans and/or shaft of the shaft of the penis. Alternatively or in addition, in the methods described herein, a polylactic acid or a reconstituted polylactic acid may be injected sub-cutaneously into the spongy region and/or corona of the glans. Alternatively, or in addition, a polylactic acid or a reconstituted polylactic acid may injected sub-cutaneously injection onto the Buck’s fascia tissue layer of the shaft of said penis. Filler compositions comprising polylactic acid suitable for use in the penis enlargement methods described herein are commercially available filler compositions suitable for use in the methods described herein is commercially available. For example, a suitable sterile lyophilized polylactic acid filler composition for reconstitution prior to injection is available under the brand AstheFill ™ (distributed by Esthmedica Pte Ltd, Singapore), and under the brand Sculptra® Aesthetic (distributed by Galderma Laboratories, L.P., Fort Worth, Texas, USA). The Sculptra® Aesthetic polylactic acid filler composition has been FDA-approved for aesthetic facial augmentation.

Another example of a semi-permanent filler suitable for use in the methods of augmentation of human penis described herein includes an injectable composition of calcium hydroxylapatite (CaHa) also known as hydroxylapatite or hydroxyapatite (HA). It is a naturally occurring bone mineral form of calcium apatite with the formula Cas(P04)3(0H), but is usually written Caio(P04)6(OH)2to denote that the crystal unit cell comprises two entities. A synthetic dermal and/or sub-dermal CaHa filler composition suitable for use in the methods of the present invention includes an injectable semi-solid (e.g, gel) product generated by suspending calcium hydroxylapatite microspheres usually of 25—45 microns diameter in a gel earner of carboxymethylcellulose (USP). One such product is commercially available under the brand Radiesse® (Bioform Inc, USA) which is a sterile, latex-free, non-pyrogenic, semisolid, cohesive, injectable implant, principally made out of synthetic CaHA microspheres in a gel carrier that consists primarily of sterile water and glycerin whereby the gel structure is formed by the addition of a small amount of carboxymethylcellulose (USP). Once the filler composition is injected into the human body, the gel component including the USP is resorbed and dissipated in vivo e.g., about 2 to 3 months after injection and is replaced with soft tissue growth such as collagen, while the CaHA remains at the site of injection. In vivo the small CaHA microspheres act as a scaffold that promotes new tissue formation similar to its surrounding environment. Inside soft tissues such as the dermis or sub-dermis of the penis, the deposited CaHa particles support fibroblastic ingrowth and new collagen formation, without calcification. Accordingly, the properties of CaHA mimic the environment into which it is placed. Furthermore, as CaHA is biodegradable (dissolved into calcium and phosphate ions through body’s own normal metabolic processes e.g., by following the same metabolic pathway as bone debris resulting from common bone fractures), a gradual breakdown of the particles occurs until complete removal of the CaHa particles (e.g., also by phagocytosis) is achieved. Because the CaHA microspheres present in the Radiesse® product have the same chemical composition as the inorganic constituent of teeth and bone, and can exhibit an extensive safety profile with little or no antigenicity, filler compositions comprising CaHA may be particularly suited for use in the penile enlargement methods describe herein. The

Radiesse® product has been FDA approved for esthetic facial augmentation in the US.

Another example of a semi-permanent filler suitable for use in the methods of augmentation of human penis described herein includes an injectable composition comprising hydroxyethylmethacrylate (HEMA).

Another example of a semi-permanent filler suitable for use in the methods of augmentation of human penis described herein includes an injectable composition comprising dextran. Injection of dextran filler composition generates neocollagenesis and neovasculogenesis among dextran particles at the injection site. Although the base ingredient, dextran, is biodegradable in vivo with 100% biodegradation may be observed e.g., within 1 or 2 years from injection, the penile enlargement effect continues for long duration after dextran degradation at least due to newly generated collagen tissue at the injection area. Accordingly, the duration of effectiveness of penile enlargement is expected to be at least two to three years post injection. An example of a suitable filler composition is an injectable liquid composition of pure cross-lined dextran particles. Such composition is commercially available under the brand name LiCol D™ (distributed by DentalSuppl, Lot 07-51, 7th floor, Beijaya Times Square, Nol. Jalan imbi, 55100, Kuala Lumpur, Malaysia). Another suitable injectable filler composition for use the method of the present invention includes a filler composition comprising polymethylmethacrylate (PMMA), cross-linked dextran, hydroxypropyl methylcellulose (HPMC) and physiological saline or distilled water e.g., as described in US Patent publication No. 20080279806 Al, the contents of which are incorporated herein in their entirety by way of reference. Such a filler composition can be safely applied to the human penis in the methods described herein, with longevity of greater than at least 12 months. Another example of such filler composition includes a dermal filler containing 75% cross-linked dextran and 15% PMMA by volume (cross-linked dextran and PMMA are microspheres of 45 to 120 pm and 30 to 120 pm, respectively) which is commercially available under the brand Lipen-10™ (Chungwha Medipower Corporation, Seoul, Korea) which has been approved for soft tissue augmentation by the Korean Food and Drug Administration. A similar filler composition containing 90% pure cross-lined dextran particles (LiCol D™ product mentioned above) and 10% by volume of PMMA is commercially available under the brand LiCol P™ (distributed by DentalSuppl, Lot 07-51, 7th floor, Berjaya Times Square, Nol. Jalan imbi, 55100, Kuala Lumpur, Malaysia).

Temporary filler(s)

For example, a suitable injectable temporary filler composition for use in the penile augmentation methods described herein is an injectable composition comprising hyaluronic acid (HA) also known as hyaluronan. HA is a non-sulfated glycosaminoglycan cellular matrix polymer that is naturally produced and distributed widely throughout the human body in connective, epithelial, and neural tissues. For example, HA is naturally found in abundance in the different layers of the skin (e.g., between epidermis and dermis) where it can serve e.g., to ensure good hydration, and to conjugate cells each other, serves as a lubricant among cells, and to participate in tissue repair mechanisms. However, with age, the quantity and production of HA (and other matrix polymers present in the skin such as collagen and elastin) decreases and the degradation rate of HA in the body decreases with age. Preferably, the HA used as a filler composition in the penile enlargement methods of the present invention is artificially synthesized. In one example the HA is used as the main component in an injectable filler composition. Alternatively, the HA can be used in an injectable filler composition in combination with one or more other temporary and/or semi-permanent and/or permanent components. For example, a suitable injectable (e.g., gel or liquid) filler compositions comprising HA as the main component are commercially available under the brands Rofilan also marketed as Rofilan Hylan Gel (Philoderm aesthetics, Heusing 16, Breda, Netherlands; and Cairo Tech, Nasar City, Egypt), Teosyal (Teoxane Laboratories, Geneva, Switzerland), Surgiderm (including Surgiderm®, Surgiderm® 18, Surgiderm® 24XP, Surgiderm 30XP) by Allergan Inc., 2525 Dupont irvine, CA 92612, US, Captique (Inamed Corporation, Santa Barbara, CA, US; and Genzyme Corporation, Cambridge, MA, US), Esthelis (Anteis SA, rue de Veyrot, Meyrin, Geneva, Switzerland), Elevess (Anika Therapeutics, Bedford, MA, US), Hylaform or Hylaform Plus (Inamed Coiporation, Santa Barbara, CA, US; and Genzyme Corporation, Cambridge, MA, US), Juvederm (Allergan Inc., 2525 Dupont irvine, CA 92612, US), Perlane (Galderma Laboratories L.P., Fort Worth, TX, US), Prevelle (Mentor Corporation/Mentor Worldwide LLC, Technology Drive Irvine, CA, US), Restylane (Galderma Laboratories L.P., Fort Worth, TX, US; Medicis Aesthetics Inc., Scottsdale, AZ 85256, US), and Puragen (Mentor Corporation/Mentor Worldwide LLC, Technology Drive Irvine, CA, US). Preferably, the penile enlargement effect achieved using any one or more filler composition(s) comprising HA as the main component is sustained in the subject for at least 3 to 18 months post injection.

In another example, a suitable injectable temporary filler composition for use in the penile enlargement methods described herein is an injectable composition comprising collagen. Collagen is a structural protein in the extracellular space in the various connective tissues in humans, and can be found in skin, tendons, bones and muscles. It is the most abundant protein in the human body. In the skin, collagen make up to 80% of the skin, and maintains the skin's integrity. Like HA, collagen production decreases with age and collagen breaks down with advancing age. Because collagen is naturally occurring in the human body and is resorbable it is suitable for use as a temporary injectable filler in the methods of the present invention. In one example collagen can be used as the main component in an injectable filler composition. Alternatively, the collagen can be used in an injectable filler composition in combination with one or more other temporary and/or semi-permanent and/or permanent components. For example, a suitable injectable filler compositions comprising human collagen as the main component are commercially available under the brands CosmoDerm (Allergan Inc., 2525 Dupont irvine, CA 92612, US; Vanity Cosmeceutical Sdn. Bhd. 47600 Subang Jaya, Selangor, Malaysia) and Cosmoplast (Allergan Inc., 2525 Dupont irvine, CA 92612, US). Also suitable injectable filler compositions comprising bovine collagen as the main component are commercially available under the brands Zyderm (Inamed Corporation, Santa Barbara, CA, US) and Zyplast (Inamed Corporation, Santa Barbara, CA, US). Also a suitable injectable filler composition comprising porcine collagen as the main component is commercially available under the brands Evolence 30 (by ColBar LifeScience, now part of OrthoNeutrogena, a division of Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company). Preferably, the penile enlargement effect achieved using any one or more filler composition(s) comprising HA as the main component is sustained in the subject for at least 3 to 12 months post injection.

In another example, a suitable injectable gel filler composition comprising a combination of semi-permanent filler and collagen is commercially available under the brand Bellafill (Suneva Medical, Inc., San Diego, CA, US). The Bellfil combination product is a hybrid gel filler consisting of millions of synthetic microspheres of PMMA suspended in purified bovine collagen.

In another example, a suitable injectable temporary filler composition for use in the penile enlargement methods described herein is an injectable composition comprising HA and cross-linked dextran (DEAE Sephadex) as the main filler components are commercially available under the brand Matridex and CRM Dx (Biopolymer GmbH & Co. KG, Walsmuhler StraBe 18. D-19073 Dummer, Germany). When using this filler composition in the methods of the penile element of the present invention a tissue volume enlargement effect is obtained immediately after injection into the penis. The HA is decomposed and absorbed over about 6 to 12 months, and then the empty space produced is filled with autologous collagen newly produced by a stimulation of the cross-linked dextran ensuring that the penile enlargement effect continues for at least a further about 1 to 2 years.

Another temporary filler composition suitable for use in the penile enlargement methods described herein, includes a composition comprising ascorbic acid 2-glucoside (AA2G) covalently conjugated to crosslinked hyaluronic acid via 1,4-butanediol diglycidyl ether (BDDE) as described in detail in US Patent No. 9,393,263 the contents of which are incorporated herein by cross-reference in their entirety.

In another example, a suitable injectable temporary filler composition for use in the penile enlargement methods described herein is an injectable composition comprising human and/or bovine fibroblast.

In another example, a suitable injectable temporary filler composition for use in the penile enlargement methods described herein is an injectable composition comprising fascia autographs.

EXAMPLE 1: WIDENING AND/OR LENGTHENING PENIS GLANS WITH INJECTABLE FILLER COMPOSITION ADMINISTERED SUB-CUTANEOUSLY

This example demonstrates a method of widening and/or lengthening the glans of a human male subject by one or more sub-cutaneous injection(s) of a filler composition into the glans of the penis.

With the human subject under general anesthesia in a certified hospital or medical clinic and the method is performed under sterile conditions, an amount of about 1 ml to 10 ml, preferably about 5 ml to about 10 ml and more preferably about 4ml to about 10 ml of a filler composition is injected sub-cutaneously into the main spongy region of the male subject so as to bulk up the glans increasing its transverse diameter and longitudinal length. Preferably, according to this example, the filler composition can administered to the main spongy region of the glans by multiple by sub-cutaneous injections whereby an amount of about 0.2 ml to 1.0 ml, preferably about 1 ml, is delivered to the main spongy region of the glans in any one single injection. Although multiple injections whereby each injection delivers a small amount of the filler composition into the spongy region of the glans is preferred, it will be understood that it may also be possible to achieve an equivalent enlargement effect in the glans with a single injection that delivers the full amount of the filler composition. Once the filler composition has been delivered to the main spongy region of the glans, the injected filler composition is manually manipulated so as to be sculptured into the desired shape to achieve the enlargement effect.

Alternatively, or in addition, an amount of about 1 ml to about 10 ml, preferably about 5 ml to about 10 ml of a filler composition is injected sub-cutaneously into the corona (rim) region of the penis glans above the neck of the penis so as to make the corona region of the glans more prominent. According to this example, the filler composition can be administered to the corona regions of the glans by multiple by sub-cutaneous injections whereby an amount of about 0.2 ml to 1.0 ml, preferably about 1 ml, is delivered to the spongy region of the glans in any one single injection. Although multiple injections whereby each injection delivers a small amount of the filler composition into the corona of the glans is preferred, it will be understood that it may also be possible to achieve an equivalent enlargement effect in the coronal of the glans with a single injection that delivers the full amount of the filler composition. Once the filler composition has been delivered to the corona region of the glans, the injected filler composition is manually manipulated so as to be sculptured into the desired shape to achieve the enhancement in prominence effect of the corona.

Widening and/or lengthening of the glans of the penis by one or more sub-cutaneous injection(s) into the spongy region and/or the corona region of the penis by this method, can be achieved using semi-permanent or permanent filler composition. If a permanent filler composition is used, then the filler composition is preferably one which comprises a polyacrylamide (PAAG) gel, medical grade silicone (liquid or gel), polymethylmethacrylate (PMMA) microspheres (e.g., in gel or liquid) or polytetrafluoroethylene (PTFE). Most preferably, the permanent filler composition employed in the present method comprises PAAG gel or medical grade silicone. Alternatively, if a semi-permanent filler composition is used, then the filler composition is preferably one which comprises a polylactic acid, calcium hydroxylapatite (CaHa) microspheres e.g., in gel (such as USP gel), hydroxyethylmethacrylate (HEMA) or dextran (e.g., pure cross-linked dextran or a combination of PMMA and cross-linked dextran) as the main filler material.

According to this example, glans enlargement using a semi-permanent or permeant filler composition can be achieved by administering the filler composition by multiple subcutaneous injections as described above. First, a needle (for example a 25 gauge needle) is inserted into the spongy region of the glans, commencing at or near the coronal sulcus or groove (BP groove). No filler composition is injected into the glans as the needle is being inserted in this first sept. Second, while the needle is still in the spongy region of the glans, the needle is advanced inside the glans towards and as far as the tip of the glans. Third, then the needle is slowly withdrawn, and at the same time as the needle is withdrawn the filler composition is injected sub-cutaneously into the spongy region of the glans. Once the needle has been completely been withdrawn from the glans, the above three steps are then repeated so that so that the filler composition is administered to the glans of the penis by multiple subcutaneous injections advancing progressively in a fan-like manner transversely along the arcuate circumference of the glans of the penis, whereby each injection delivers an amount, for example of about 0.2 ml to about 1.0 ml, preferably about 0.5 ml to about 1.0 ml, or about 1.0 ml of the filler composition to the spongy region of the glans staring at the tip of the glans adjacent to the urethra and progressing longitudinally from the tip to the point of insertion of the needle at or near the BP groove as the needle is withdrawn during each injection. The injections are repeated until the main spongy body region of the glans is enlarged as observed by the widening and/or lengthening of the dimensions of the glans of the penis when compared with the dimensions of the spongy region of glans of the penis of the same subject prior to delivery of the filler composition.

According to this example, enlargement of the corona region of the glans can be achieved by administering the filler composition by multiple sub-cutaneous injections into the corona (rim) region of the glans. First, a needle (for example a 25 to 27 gauge needle) is inserted into the sub-cutaneous layers of the corona region of the glans. Second, then the needle is gradually withdrawn. At the same time as the needle is withdrawn, the filler composition is injected sub-cutaneously into the sub-cutaneous layers of the corona. These injections are repeated transversely along the arcuate circumference of the coronal (rim) of the glans so as to bulk the corona region.

To avoid post-administration formation of granuloma in the penis by the filler composition, when administering the semi-permanent or permanent filler composition subcutaneously into the main spongy region of the glans or into the corona region by the method of this example, it is important to take care not to deliver the filler composition into the glans of the penis too close to the dermal (skin) layer of the glans. In other words, when performing the method according to this example, it is preferable to avoid administering the semipermanent or permeant filler composition into the dermal layer and even into the loose areolar tissue layer beneath the dermal layer of the glans.

As described above, once the injected filler composition is delivered into the spongy region and/or the corona of the glans, the injected filler composition can be manually sculpted to the desired shape.

While the method of this example can theoretically be performed under local anesthetic, a general anesthetic ought to be performed when a semi-permanent and permanent injectable filler composition is used. In this case, it is strongly recommended that the method is performed under general anesthetic of the subject together with administration of a local penile infra pubic nerve blocker to block the dorsal nerves of the penis prior to commencement of any injection. A completely anesthetic penis is most preferred to avoid mistakes in filler placement when injecting semi-permanent or permanent filler composition. For example, an amount of about 10 ml to about 20 ml of anesthetic (such as Chirocaine) may be administered to inhibit any sensation in the penis prior to injection of the filler composition.

The duration of the enlargement effect of the glans of the penis (enlargement of main spongy body or corona) achieved by the method of this example, would vary depending on the nature and make-up of the filler composition. For example, an enlargement effect of at least 3 or more years, preferably at least 6 or more year and more preferably 9 or more years post injection is expected when the filler composition comprises a permanent filler such as PAAG, medical grade silicone (liquid or gel), PMMA or PTFE. On the other hand, an enlargement effect of the main spongy body and/or corona of the glans is expected to be observed from about 6 months to 3 years, preferably from about 2 to 3 years at minimum from administration of the filler composition, when said filler composition used in this method comprises a semi-permeant filler such as polylactic acid, CaHa, HEMA or dextran.

Although the above illustration of this example has focused on use of semi-permanent or permanent filler compositions, it will be understood that the method of this example can also be performed using a temporary filler composition. Preferably the temporary filler composition is one which comprises collagen, hyaluronic acid (HA), cultured fibroblasts, or human fascia autograph as the main filler component. Most preferably, the temporary filler composition comprises collagen or HA as the main filler component. It will be understood that in the event that a temporary filler composition is employed then duration of the enlargement effect of the glans of the penis (enlargement of main spongy body or corona) achieved will be sustained for about 6 months to about 3 years, preferably for about 6 to 24 months, from administration of the filler. Accordingly, repeated sub-cutaneous injections of the temporary filler composition about every 6 months to 3 years would be required to maintain and/or top up the glans enlargement effect. Furthermore, if a temporary injectable filler composition is used then the subcutaneous injection of the filler compassion to the glans can be performed under local anesthetic of the penis. In this case, administration of a local penile infra pubic nerve blocker to block the dorsal nerves of the penis as mentioned above, is optional.

Furthermore, infection to the penis involving administration of the filler compositions can be disastrous to the subject. Such infections can easily arise from improperly disinfected tools, filler compositions and/or due to generally non-sterile environment where the method is performed, and are generally associated with penile augmentation methods not performed in certified hospitals and/or medical clinics where hygiene and sterile medical practices are relaxed. Accordingly, it is important that the method of the present example is performed under sterile conditions in an operating room of a certified hospital and/or medical practice and is performed by an appropriately qualified and certified medial professional such as a surgeon.

EXAMPLE 2: WIDENING AND/OR LENGTHENING PENIS GLANS AND/OR SHAFT USING INJECTABLE FILLER COMPOSITION ADMINISTERED INTRA-DERMALLY

This example demonstrates a method of widening and/or lengthening the penis shaft and/or glans of a human male subject by administering one of more intra-dermal injections of a semi-permanent or temporary filler composition.

With the human subject under local or general anesthesia in a certified hospital or medical clinic and the method is performed under sterile conditions, an amount of about 1 ml to 15 ml, preferably about 3 ml to about 10 ml and even more preferably about 4 ml to 10 ml, of a temporary or a semi-permanent filler composition is injected (e.g., with a 25 to 27 gauge needle) into the dermal layer and/or into the loose areolar tissue layer located beneath the dermal layer of the glans of the penis, so as to widen and/or lengthen the glans of the penis.

The injection(s) of the filler composition into the dermal layer and/or into the loose areolar tissue can take place anywhere along the circumference of the main spongy body region and/or the corona of the penis glans, to achieve the desired glans widening and/or lengthening effect and/or to achieve a desired prominence of the corona of the glans. It is preferable that the filler composition is delivered by multiple injections administered serially along the arcuate circumference of the main spongy body and/or corona region of the glans, whereby each injection delivers an amount e.g., of about 0.2 ml to about 1.0 ml, preferably about 0.5 ml or about 1.0 ml of the filler composition to the glans. The injections are repeated until the main spongy body region and/or corona region of the glans is enlarged as observed by the widening and/or lengthening of the dimensions of the glans compared with the dimensions of the spongy body region and/or corona of the penis of the same subject prior to delivery of the filler composition. Although use of multiple injections (e.g., whereby each injection delivers a small amount of the filler composition) into the glans of the penis is preferred, it will be understood that it is also be possible to achieve some enlargement effect in the glans with only a single injection. Once the filler composition has been delivered intra-dermally as described, the injected filler composition is manually manipulated so as to be sculptured into the desired shape to achieve the enlargement effect.

Alternatively, or in addition, an amount of about 1 ml to about 10 ml, preferably about 4 ml to about 10 ml of a temporary or semi-permanent filler composition filler composition is injected {e.g., with a 25 to 27 gauge needle) into the dermal layer and/or into the loose areolar tissue layer beneath the dermal layer of the shaft of the penis, so as to widen and/or lengthen the shaft. It is preferred that the filler composition is administered to the shaft by multiple injections along the longitudinal and traverse circumference of the shaft whereby an amount of about 0.2 ml to 1.0 ml, preferably about 0.5 ml or about 1 ml, is delivered to the shaft region of the glans in any one single injection. Although multiple injections (e.g., whereby each injection delivers a small amount of the filler composition) into the shaft is preferred, it will be understood that it is also possible to achieve some shaft widening using only a single injection into the dermal layer or into the loose areolar tissue layer of the shaft. Once the filler composition has been delivered to the dermal layer or the loose areolar tissue layer of the shaft, the injected filler composition is manually manipulated so as to be sculptured into the desired shape to achieve shaft widening in the desired shape.

The injectable temporary filler compositions that can be employed in the method according to this example include (but not limited to) filler compositions which comprise collagen, hyaluronic acid (HA), cultured fibroblasts, or human fascia autograph as a filler component. Preferably, the temporary filler composition comprises collagen or HA as a filler component. The duration of widening and/or lengthening effect of the glans and/or widening of the shaft of the penis achieved by performing the method according to this example using an injectable temporary filler composition is sustained for about 6 months to 3 years, preferably for at least about 6 to 24 months, from administration of the filler composition. Accordingly, repeated injections of the filler composition about every 1 to 3 years is preferable to maintain the widening and/or lengthening of the glans or widening of the shaft by this method when using a temporary filler composition.

Alternatively, the method according to this example may also be performed using an injectable semi-permanent filler compositions. Examples of semi-permanent filler compositions that may be used include (but not limited to) filler compositions which comprise as the main filler material polylactic acid, CaHa e.g., microspheres in gel (such as USP gel), HEMA or dextran (e.g., pure cross-linked dextran or a combination of PMMA and cross-linked dextran). The duration of widening and/or lengthening effect of the glans and/or widening of the shaft of the penis achieved by performing the method according to this example using a semi-permanent filler composition is sustained for at least about 1 to 3 years, preferably for at least about 2 to 3 years, from administration of the filler composition. Accordingly, repeated injections of the filler composition about every 2 to 3 years is preferable to maintain the widening and/or lengthening of the glans or widening of the shaft by this method when using a semi-permanent filler composition.

While the method of this example can be performed under general anesthetic, a general anesthetic of the subject may not be required and the method can and may be performed using only a local anesthetic of the penis, especially if a temporary filler composition is used. If the method is performed under local anesthetic only, a local infra-pubic nerve blocker such as Chirocaine may optionally be administered to the subject before delivery of the filler composition to the glans and/or shaft of the penis. For example, an amount of about 10 ml to about 20 ml of anesthetic (such as Chirocaine) may be administered to inhibit any sensation in the penis prior to injection of the filler composition. On the other hand, if a semi-permanent injectable filler composition is used, then it is strongly recommended that the method is performed under general anesthetic of the subject together with administration of a local penile infra pubic nerve blocker to block the dorsal nerves of the penis. A completely anesthetic penis is most preferred to avoid mistakes in filler placement when injecting semi-permanent filler composition.

EXAMPLE 3: WIDENING AND/OR LENGTHENING PENIS GLANS AND/OR SHAFT USING INJECTABLE FILLER COMPOSITION ADMINISTERED INTRA-DERMALLY

This example demonstrates a method of widening the shaft of a penis of a human subject by administering using one or more sub-cutaneous injection(s) onto the Buck’s fascia tissue layer of the shaft an amount of an injectable semi-permanent or permanent filler composition.

With the human subject under general anesthesia in a certified hospital or medical clinic and whereby the method is performed under sterile conditions, a total amount of about 1 ml to about 100 ml, preferably about 40 ml to about 80 ml or about 50 ml to about 100 ml of a permanent or a semi-permanent filler composition is administered sub-cutaneously onto the Buck’s fascia tissue layer of the shaft. To achieve this, first, a small a stab incision of about 1-2 mm in diameter is made in the skin fold at the peno-pubic area of the penis shaft to access the Buck’s fascia tissue layer located subcutaneously along the penile shaft. Then, an injection cannula (I.C) such as a spatulate cutting edge injection cannula e.g., commercially available under the brand AquaMid (Contura International A/S, Soeborg, Denmark) is inserted subcutaneously into the penis shaft through the stab incision. The I.C is advanced subcutaneously along the Buck’s fascia tissue layer of the shaft from the site of incision up to as far as or very near the coronal sulcus or groove (BP Groove) being the rim/corona of the glans. While the I.C is advanced subcutaneously in the shaft, no filler composition is administered into the penis. Then the I.C is gradually withdrawn backwards while in the shaft of the penis and, at the same time as the I.C is withdrawn, an amount of about 0.5ml to about 1.5 ml, preferably about 1 ml, of the filler composition is injected once at a time directly onto the Buck’s fascia tissue layer of the shaft. The above steps of making new incision at the peno-pubic area of the penis shaft, inserting an I.C into the incision, advancing the I.C subcutaneously along the Buck’s fascia tissue layer of the shaft, and withdrawing and simultaneously injecting the filler composition onto the Buck’s fascia tissue layer of the shaft, are repeated serially so as to fill the sub-cutaneous area of the shaft with the filler composition. It is preferable that these longitudinal injections of the filler composition onto the Buck’s fascia tissue layer of the shaft are serially repeated at least until the subcutaneous area of the shaft of the penis located above the right and left corpora cavernosa regions of the penile erectile tissue is uniformly filled with the semi-permanent or permanent filler composition along the dorsal circumferential length of the penis shaft. In other words, the above method steps are serially repeated to serially administer longitudinally the semi-permanent or permanent filler composition onto the Buck’s fascia tissue of the penis until the subcutaneous area of the penis shaft is uniformly filled with the filler composition along the dorsal circumferential length of Said shaft at least from the corona of the glans between the coipus spongiosum region and the right corpora cavernosa region of the penile erectile tissue and around the dorsal circumference of the penis to the corona of the glans between the corpus spongiosum region and the left corpora cavernosa region of the penile erectile tissue. The shaft is then manually sculpted to produce a uniform smooth result. An overall shaft widening effect of about 10 to 20 mm may be observed when injecting about 40 ml to about 80 ml filler composition by this method.

It is the inventor’s experience that an amount of about at least 40 ml to about 80 ml may be required to produce a penile shaft widening enhancement result which is equivalent to that achieved using implantation of a dermal fat graft and/or acellular matrix onto the Buck’s fascia e.g., by employing methods disclosed herein and/or as previously disclosed in the present inventor’s earlier patents AU Pat. No. 742359, AU Pat No. 760083, AU 777498, US Pat No. 7,637,862 and US pat No. 7,273,449). For example, shaft widening by those or similar methods is achieved by a dermal fat graft and/or acellular matrix being placed in situ on the Buck’s fascia tissue of the penis of a subject by performing a process comprising (i) degloving the penis to expose the Buck’s fascia tissue layer of the penis, (ii) suturing to the exposed Buck’s fascia tissue said block of dermal fat graft and/or acellular matrix; and then (iii) reducing the penile skin.

The method of the present example can also be practiced on a male subject having previously undergone penile widening procedure whereby a block of dermal fat graft and/or acellular matrix has been previously placed in situ onto the Buck’s fascia tissue of the subject’s penis (for example, by a method as disclosed herein and mentioned directly above). In such embodiment, the method of this example comprises administering sub-cutaneously the amount of the semi-permanent or permanent filler composition on the Buck’s fascia tissue layer superficial to the previously placed in situ block of dermal fat graft and/or acellular matrix.

During shaft widening by the method of this example, although it is possible to cover the area of the corpus spongiosum i.e., the Buck’s fascia tissue layer above the corpus spongiosum, it is recommended not to do so. This is because the corpus spongiosum is rich with sensory nerve endings it is preferred to do nothing to diminish sensation in this area.

While the method of this example may theoretically be performed under local anesthetic, the inventor strongly recommends that the method is performed under a general anesthetic especially given that a semi-permanent or permanent injectable filler composition is employed. In addition to the method being performed when the subject is under a general anesthetic is it strongly recommended the subject is administered with a local penile infra pubic nerve blocker to block the dorsal nerves of the penis prior to commencement of any filler injection. A completely anesthetic penis is most preferred to avoid mistakes in filler placement when injecting semi-permanent or permanent filler composition. For example, an amount of about 10 ml to about 20 ml of anesthetic (such as Chirocaine) may be administered to inhibit any sensation in the penis prior to injection of the filler composition.

The duration of the widening effect on the penile shaft achieved by performing the method of this example, depends on the nature and make-up of the filler composition. For example, an enlargement effect of at least 3 or more years, preferably at least 6 or more years and more preferably 9 or years post administration of the filler composition is expected when the filler composition comprises a permanent filler such as PAAG, medical grade silicone (liquid or gel), PMMA or PTFE. On the other hand, shaft widening is sustained for at least about 6 months to 3 years, preferably from about 2 to 3 years at minimum years from administration of the filler composition, when said filler composition used comprises a semi-permeant filler such as polylactic acid, CaHa, HEMA or dextran.

Although the above illustration of this example has focused on use of semi-permanent or permanent filler compositions, it will be understood that the method of this example can also be performed using a temporary filler composition. However given the invasive nature of the method according to this example, use of temporary filler compositions generating only short lived widening effect, may not be attractive option to subjects. Nevertheless, if a temporary filler composition is employed then preferably the temporary filler composition is one which comprises collagen, hyaluronic acid (HA), cultured fibroblasts, or human fascia autograph as the main filler component. Most preferably, the temporary filler composition comprises collagen or HA as the main filler component. It will be understood that in the event that a temporary filler composition is employed then duration of the enlargement effect of the glans of the penis (enlargement of main spongy body or corona) achieved will be sustained for about 6 months to about 3 years, preferably for about 6 to 24 months, from administration of the filler. Accordingly, repeated sub-cutaneous injections of the temporary filler composition about every 6 months to 3 years would be required to maintain and/or top up the glans enlargement effect. Furthermore, if a temporary injectable filler composition is used then the subcutaneous injection of the filler compassion to the glans can be performed under local anesthetic of the penis. In this case, administration of a local penile infra pubic nerve blocker to block the dorsal nerves of the penis as mentioned above, is optional.

Furthermore, as infection to the penis involving administration of the filler compositions can be disastrous to the subject, it is important to administer the filler composition under sterile conditions and in an operating room of a certified hospital and/or medical practice. It is also important that the method is performed by an appropriately qualified and certified medial professional such as a surgeon.

Summary of procedures entailed in Examples 1 to 3: 1. Broadly the procedures entail enlargement of the glans penis with injectable material such as Polyacrylamide Gel, medical grade Silicone & the like substances.

The injection is into the cavernous body of the glans so as to generally bulk up the glans increasing it’s transverse diameter & longitudinal length. In preferred forms the injectable material is placed into the rim of the glans to make the rim more prominent. The injectable material is preferably of the permanent type but may be by one of the dermal fillers which are of a temporary or semi-permanent nature lasting only a few months to 2-3 years whereas the polyacrylamide gel & the medical grade silicone are permanent. 2. In preferred forms these agents are used in widening the penis shaft. In preferred forms, the permanent fillers (polyacrylamide gel & medical grade silicone etc.) are placed in the subcutaneous layer, on buck’s fascia or superficial to an insitu, previously placed, dermal fat graft. In some forms, amounts of 50 to 100 mis are required to be so placed to produce effective shaft enlargement. The intradermal fillers may be placed in the dermis of the shaft skin &/or just deep to that layer. A smaller volume can achieve a look similar to the permanent fillers but which lasts only 6 to 24 months, rarely for three years, post injection. These latter require repeat injections every 1 to 3 years to maintain the enlargement effect.

Examples of the permanent fillers include but are not restricted to, polyacrylamide gel, medical grade silicone, polymethylmethacrylate, and polytetrafluoroethylene.

Examples of the semi-permanent dermal fillers include, but are not restricted to, polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate and dextran.

Examples of the temporary fillers include, but are not restricted to, collagen, hyaluronic gels, cultured fibroblasts (human or bovine) & fascia autographs (human).

Summarised in an alternative form examples 1 to 3 exemplify a technique for shaft and/or glans enlargement by injectables made up of the following steps: 1. Glans enlargement by temporary fillers is achieved by multiple intradermal injections of the filler followed by manual sculpting to the desired shape. 2. Gians enlargement using semi-permanent or permeant fillers is achieved by placing the filler subcutaneously by multiple injections by inserting the needle (usually a 25 gauge needle) into the cavernous tissue of the glans at the BP groove & advancing the needle towards & as far as the tip of the glans. Then as the needle is withdrawn the filler is injected subcutaneously ( taking care not to be too close to the glans skin otherwise a granuloma may result).

Starting adjacent to the urethra & progressing around the glans, fan like, until the body of the Glans is enlarged. Next the same manoeuvre is repeated transversely around the rim of the glans so as to bulk it up. Finally the filler is manually sculpted to the desired shape. 3. The shaft enlargement by temporary fillers is achieved as per (1) above. 4 The Shaft enlargement using semi-permanent or permanent fillers is achieved by placing the filler subcutaneously by multiple transcutaneous injections or (the preferred technique) by making a small 1-2 mm stab incision in the skin fold at the peno- pubic junction area of the Penis shaft and inserting a spatulate cutting edge injection cannula (refer to Figure 11).

The injection cannula (I.C.) is advanced subcutaneously as far as the BP Groove (I.e. The rim of the glans) & then as one withdraws the I.C. The filler is injected one millilitre at a time. This manoeuvre is repeated using a series of longitudinal injections until the subcutaneous area, of the shaft, from the groove between the corpus Spongiosum & the corpus cavernosum, on the right, around to the corresponding groove, on the left, is uniformly filled with the filler. The shaft is then manually sculpted to produce a uniform smooth result. A quantity of between 40 & 80 ml of filler may be required to produce the same result as is achieved using dermal Fat grafts (refer to examples 4 to 7 below). During shaft enlargement although it is possible to cover the area of the corpus spongiosum but this is not recommended as the corpus spongiosum is rich with sensory nerve endings and it is deemed to be wise to do nothing to diminish sensation in this area.

Whilst 1 and 3 above can and may be performed using local anaesthetic it is recommended that with 2 and 4 above that they be performed under general anaesthetic plus local Penile Infra-pubic nerve block blocking the dorsal nerves of the Penis & in a sterile operating room environment. A completely anaesthetic Penis is necessary to avoid mistakes in filler placement.

But more importantly as infection involving the filler can be disastrous the environment must be sterile hence the recommendation that the injection be done in sterile conditions e.g. In the operating room in a certified hospital.

EXAMPLE 4: SURGICAL PENILE LENGTHENING

With the patient under general anesthesia and in the supine position the lower abdomen, perineum and thighs are prepared and draped. In the classic procedure, a transverse suprapubic incision is made measuring approximately 3 cm 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.

Dissection is earned down by a blunt technique on either side of the suspensory 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 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 earned 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 right and left Gracilis muscles in front of the penis. Two more deep stay sutures of 0 Maxom (or other suture material) are then inserted into the pubic bone inferior surface laterally and left untied. A fifth, sixth and seventh 0 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 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 perineal and scrotal skin on either side is then identified approximately 3 cm 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. 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.

EXAMPLE 5: 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 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 1 Ocm or more cms. The actual size will be determined by the initial size of the penis measured preoperatively. Once the epidermis has been 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 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.

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 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 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 circumference.

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 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 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.

EXAMPLE 6: PENILE WIDENING - ACELLULAR MATRIX GRAFT

Penile widening may also be achieved by substituting the dermal fat grafts with an 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 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.

EXAMPLE 7: 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 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 described above in regard to penile lengthening and attached to their other structures. All wounds are then closed as described above.

EXAMPLE 8: POST-OPERATIVE TREATMENT REGIMES

The abovementioned procedures of the examples and as elsewhere described advantageously are applied in combination with one or more of the following post-operative treatment regimes, namely either one or both of the stretching exercise or the drug treatment regime. (i) Post-operative penile 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 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 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 &, 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 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 exercise blocks per day is normally 3, but this may be varied to suit the specific situation.

Preferred ranges: 20 seconds minimum with an absolute maximum of 30 seconds. Multiples of this period may ran 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 ergonomic factor.

The above regime can be used following one or more of the following operative procedures: (ii) Post operative drug treatment regime A treatment regime which can be used to advantage in respect of any of the above described procedures.

Initially, post-operatively a drug treatment regime can include 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 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 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-dichlorophenyl)-2-(imidazol-l-ylmethyl)-l,3-dioxolan-4-yl]methoxy]phenyl]-piperazine (also known inter cdia 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 intravenously to the patient- again to suppress erection. Tirazole antifungal compounds such 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, 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;

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 two weeks - again to suppress erection;

Prednisone (also known by the chemical name: pregna-l,4-diene-3,l 1,20-trione, 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 minimising the amount of local tissue swelling.

EXAMPLE 9: 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 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 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.

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 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.

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 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.

Closure of the superior border of the defect created by extracting the grafts is achieved with a 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 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 inffa-pubic and para-penile tissues back up onto the upper surface of the pubic bone and lower abdominal wall. EXAMPLE 10: ENHANCEMENT WITH ARTIFICIAL ERECTION DEVICE:

In its broadest aspect, the invention further includes a method of enhancement phalloplasty of a human penis including the steps of degloving the penis to expose Buck’s fascia and dividing the coipora cavernosa circumferentially after freeing the dorsal neurovascular bundles and separating the coipus 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 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 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.

The dissection involves separating the corpus spongiosum from the inferior surface of both corpora cavernosa. Additional length of 1 cm or more in the length of the coipus cavernosum 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 1 cm longer cylinder than has been measured at the earlier part of the procedure when the corporotomy and dilatation of the corpus was performed. The gap in the corpus cavemosum 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) 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 coipus cavernosum 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 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 cavernosum 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.

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 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 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 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 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 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 coipus 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 coipus 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 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.

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 inffapubic 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 at the time of surgery as a new device then it is left deflated and a tight circumferential penile dressing applied.

EXAMPLE 11: 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 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 cavernoso 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.

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 corpora.

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 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.

Any discussion of documents, acts, materials, devices, articles or the like 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.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. A method of enlarging a penis of a human subject, comprising administering to the subject by one or more intra-dermal injection(s) an amount of a dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the glans and/or shaft of the penis.
2. The method according to claim 1, comprising administering to the subject by one or more intra-dermal injection(s) an amount of the dermal filler composition into the dermal layer of the glans of the penis to thereby widen and/or lengthen the glans penis.
3. The method according to claim 2, wherein the dermal filler composition is a temporary filler composition.
4. The method according to claim 3, wherein the temporary filler composition comprises biodegradable and/or resorbable material selected from the group consisting of: collagen, hyaluronic acid, cultured fibroblasts, human fascia autograph, and combinations thereof.
5. The method according to claim 1, comprising administering to the subject by one or more intra-dermal injection(s) an amount of the dermal filler composition into the dermal layer or into the loose areolar tissue layer beneath the dermal layer of the shaft of the penis to thereby widen the penis shaft.
6. The method according to claim 5, wherein the dermal filler composition is a temporary filler composition or a semi-permanent filler composition.
7. The method according to claim 6, wherein: (i) the temporary filler composition comprises biodegradable and/or resorbable material selected from the group consisting of: collagen, hyaluronic acid, cultured fibroblasts, human fascia autograph, and combinations thereof; and/or (ii) the semi-permanent filler composition comprises biodegradable and/or resorbable material selected from the group consisting of: polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof.
8. The method of claim 4 or claim 7, wherein the cultured fibroblasts are cultured human or bovine fibroblasts.
9. The method according to any one of claims 1 to 8, comprising administering the amount of the temporary filler to the penis glans and/or penis shaft of the subject by multiple intra-dermal injections.
10. The method of any one of claims 1 to 9, further comprising sculpting the injected dermal filler composition in the subject’s penis to a desired shape.
11. The method according to any one of claims 1 to 10, comprising performing said administration of the amount of the dermal filler composition into the penis glans and/or penis shaft under local anesthetic of the subject’s penis.
12. The method according to any one of claims 1 to 10, comprising performing said administration of the dermal filler composition into the penis glans and/or penis shaft under general anesthetic of the human subject.
13. The method according to any one of claims 1 to 12, wherein said method is performed under sterile conditions.
14. The method according to any one of claims 1 to 13, wherein said method is performed under sterile conditions in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.
15. The method according to any one of claims 1 to 14, wherein said method further comprising administering to the subject a local infra-pubic nerve blocker to thereby block dorsal nerve of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject.
16. The method according to any one of claims 1 to 15, wherein penis enlargement following administration of the temporary filler composition into the glans penis and/or shaft is maintained for at least 6 to 24 months post said administration.
17. The method according to any one of claims 1 to 16, wherein the administration of the temporary filler composition into the penis glans and/or glans shaft of the subject is repeated at least about every 1 to 3 years.
18. The method according to any of claims 1 to 17, comprising administering a total amount from about 4 ml to about 10 ml of the dermal filler composition into the penis glans and/or penis shaft.
19. The method according to any one of claims 1 to 18, comprising administering the dermal filler composition to the penis glans and/or penis shaft by multiple intra-dermal injections, wherein each injection delivers an amount of about 1 ml of said dermal filler composition to the penis glans and/or shaft.
20. A method of enlarging a penis of a human subject, comprising administering to the subject by one or more sub-cutaneous injection(s) an amount of a semi-permanent or permanent filler composition into the glans of the penis, to thereby widen and/or lengthen said glans of the penis.
21. The method according to claim 20, wherein the glans of the penis comprises a main spongy region of the glans, a corona of the glans, and a neck region of the glans located behind the corona, and wherein said method comprises administering by one or more sub-cutaneous injection(s) the amount of a semi-permanent or permanent filler composition into the spongy region and/or the corona of the glans.
22. The method according to claim 21, comprising administering the semi-permanent or permanent filler composition into the spongy region of the glans.
23. The method according to claim 21 or claim 22, comprising administering the semipermanent or permanent filler composition into the corona of the glans.
24. The method according to any one of claims 21 to 23, comprising administering the amount of the semi-permanent or permanent filler composition into the spongy region of the glans of the penis by multiple sub-cutaneous injections advancing progressively in a fan-like manner transversely along the arcuate circumference of the glans of the penis, wherein each injection delivers an amount of said filler composition commencing at the tip of the glans and progressing longitudinally from said tip to or near the corona of the glans.
25. The method of claim 24, wherein for each one of the multiple injections the semipermanent or permanent filler composition is administered into the spongy region of the glans by performing a process comprising: (i) inserting subcutaneously a needle into the spongy region of the glans near at the coronal sulcus or groove; (ii) advancing the needle inside the spongy region of the glans from the point of insertion of the needle into the glans and up to the tip of the glans near the urethra; and (iii) gradually withdrawing the needle and, at the same time, injecting the semipermanent or permanent filler composition into said spongy region so as to progressively deliver said filler composition longitudinally from said tip of the glans to said corona region, without also injecting the semi-permanent or permanent filler composition into the dermal layer of the glans.
26. The method according to any one of claims 20 to 25, further comprising sculpting the injected semi-permanent or permanent filler composition in the subject’s penis glans to a desired shape.
27. The method according to any one of claims 20 to 26, wherein: (i) the semi-permanent filler composition comprises biodegradable and/or resorbable material selected from the group consisting of: polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof; and/or (ii) the permanent filler composition comprises a non-biodegradable and/or non-resorbable material selected from the group consisting of: polyacrylamide gel, medical grade silicone, polymethylmethacrylate, polytetrafluoroethylene and combinations thereof.
28. The method according to claim 27, wherein the medical grade silicone is liquid silicone.
29. The method according to any one of claims 20 to 28, comprising performing said administration of the amount of the semi-permanent or permanent filler composition into the glans of the penis under general anesthetic of the human subject.
30. The method according to any one of claims 20 to 29, wherein said method is performed under sterile conditions.
31. The method according to any one of claims 20 to 30, wherein said method is performed under sterile conditions in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.
32. The method according to any one of claims 20 to 30, wherein said method further comprising administering to the subject local infra-pubic nerve blocker to thereby block dorsal nerve of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject.
33. The method according to any one of claims 20 to 31, wherein widening and/or lengthening the glans of the penis following administration of the semi-permanent filler composition is maintained for at least about 20 to 24 months post said administration.
34. The method according to any one of claims 20 to 33, wherein the administration of the semi-permanent filler composition into the glans penis of the subject is repeated at least about every 1 to 3 years.
35. The method according to any one of claims 20 to 34, wherein widening and/or lengthening the glans of the penis following administration of the permanent filler composition is maintained for at least 9 years post said administration.
36. The method according to any of claims 20 to 34, comprising administering a total amount from about 5 ml to about 10 ml of the semi-permanent or permanent filler composition into the glans of the penis.
37. The method according to any one of claims 20 to 36, comprising administering the semi-permanent or permanent filler composition to the penis glans by multiple subcutaneous injections, wherein each one of said injections delivers an amount of about 1 ml of said filler composition.
38. The method according to any one of claims 20 to 37, further comprising performing the method according to any one of claims 1 to 19.
39. A method of enlarging the shaft of a penis of a human subject, comprising administering by sub-cutaneously injection onto the Buck’s fascia tissue layer of the shaft of said penis an amount of an injectable semi-permanent or permanent filler composition, to thereby widen said penis shaft.
40. The method according to claim 39, wherein the amount of the injectable semi-permanent or permanent filler composition is administered sub-cutaneously onto the Buck’s fascia tissue layer along the entire length of the penis shaft.
41. The method according to claim 39 or claim 40, wherein the human subject has previously undergone penile widening procedure wherein a block of dermal fat graft and/or acellular matrix has been previously placed in situ on the Buck’s fascia tissue of the penis of said subject, and wherein said method comprises administering subcutaneously the amount of the semi-permanent or permanent filler composition on the Buck’s fascia tissue layer superficial to said previously placed in situ block of dermal fat graft and/or acellular matrix.
42. The method according to claim 41 wherein the human subject has previously undergone penile widening procedure wherein a block of dermal fat graft and/or acellular matrix has been previously placed in situ on the Buck’s fascia tissue of the penis of said subject by performing a process comprising: (i) degloving the penis to expose the Buck’s fascia tissue layer of the penis; (ii) suturing to the exposed Buck’s fascia tissue said block of dermal fat graft and/or acellular matrix; and then (iii) reducing the penile skin.
43. The method according to any one of claims 39 to 42, comprising administering onto the Buck’s fascia tissue layer of the shaft of the penis the amount of the injectable semipermanent or permanent filler composition by multiple trans-cutaneous injections.
44. The method according to any one of claims 39 to 43, wherein the administering onto the Buck’s fascia tissue layer of the shaft of the penis the amount of an injectable semipermanent or permanent filler composition, comprises the following steps: (i) making a stab incision in the skin fold at the peno-pubic area of the penis shaft; (ii) inserting sub-cutaneously through said stab incision into the penis shaft an injection cannula; (iii) advancing said injection cannula sub-cutaneously along the length of said penis shaft up to the corona of the penis glans; (iv) withdrawing the injection cannula gradually, while at the same time, injecting onto the Buck’s fascia layer of the shaft said semi-permanent or permanent filler composition; and (v) optionally, repeating steps (i) to (iv).
45. The method according to claim 44, comprising serially repeating steps (i) to (iv) to serially longitudinally administer the semi-permanent or permanent filler composition onto the Buck’s fascia tissue of the penis shaft at least until the subcutaneous area of the shaft of the penis located above the right and left corpora cavernosa regions of the penile erectile tissue is uniformly filled with the semi-permanent or permanent filler composition along the dorsal circumferential length of said penis shaft.
46. The method according to claim 44 or claim 45, comprising serially repeating steps (i) to (iv) to longitudinally serially administer the semi-permanent or permanent filler composition onto the Buck’s fascia tissue of the penis until the subcutaneous area of the penis shaft is uniformly filled with the semi-permanent or permanent filler composition along the dorsal circumferential length of said shaft at least from the corona of the penis glans between the corpus spongiosum region and the right corpora cavernosa region of the penile erectile tissue and around the dorsal circumference of the penis to the corona of the penis glans between the corpus spongiosum region and the left corpora cavernosa region of the penile erectile tissue.
47. The method according to any one of claims 44 to 46, wherein step (iv) comprises serially injecting onto the Buck’s fascia layer of the penis shaft an amount of about 1 ml of the semi-permanent or permanent filler composition at a time, while withdrawing the injection cannula.
48. The method according to any one of claims 43 to 47, wherein the injection cannula is a spatulate cutting edge injection cannula.
49. The method according to any one of claims 39 to 48, comprising administering the semi-permanent or permanent filler composition sub-subcutaneously onto Buck’s fascia tissue layer located above the right and left corpora cavernosa regions of the penile erectile tissue.
50. The method according to any one of claims 39 to 49, wherein said method does not comprise administering the semi-permanent or permanent filler composition onto the Buck’s fascia tissue layer located above the corpus spongiosum region of the penile erectile tissue.
51. The method according to any one of claims 39 to 50, further comprising sculpting the injected filler composition in the subject’s penis to a desired shape.
52. The method according to any one of claims 39 to 52, wherein: (i) the injectable semi-permanent filler composition comprises biodegradable and/or resorbable material selected from the group consisting of: polylactic acid, calcium hydroxylapatite, hydroxyethylmethacrylate, dextran and combinations thereof; and/or (ii) the injectable permanent filler composition comprises a non-biodegradable and/or non-resorbable material selected from the group consisting of: polyacrylamide gel, medical grade silicone, polymethylmethacrylate, polytetrafluoroethylene and combinations thereof.
53. The method according to claim 52, wherein the medical grade silicone is liquid silicone.
54. The method according to any one of claims 39 to 53, wherein the injectable filler composition is a permanent filler composition.
55. The method according to claim 53, wherein the injectable permanent filler composition comprises polyacrylamide gel.
56. The method according to any one of claims 39 to 55, wherein said method is performed under general anesthetic of the human subject.
57. The method according to any one of claims 39 to 56, wherein said method is performed under sterile conditions.
58. The method according to any one of claims 39 to 57, wherein said method is performed under sterile conditions in an operating room of a certified medical facility or hospital and/or by certified surgeon or medical practitioner.
59. The method according to any one of claims 39 to 58, wherein said method further comprising administering to the subject a local infra-pubic nerve blocker to thereby block dorsal nerve of the penis and inhibit any sensation in the penis and/or inhibit erection of the penis by the subject.
60. The method according to any one of claims 39 to 59, wherein penis widening of the shaft of the penis following administration of the semi-permanent filler composition is maintained for at least 20 to 24 months post said administration.
61. The method according to any one of claims 39 to 60, wherein the administration of the semi-permanent filler composition into shaft glans penis of the subject is repeated at least every 1 to 3 years.
62. The method according to any one of claims 39 to 61, wherein penis widening of the shaft of the penis following administration of the permanent filler composition is maintained for at least 9 years post said administration.
63. The method according to any of claims 39 to 62, comprising administering a total amount of about 50 to about 100 ml of the injectable semi-permanent or permanent filler composition into the shaft of the penis.
64. The method according to any one of claims 39 to 64, further comprising performing the method according to 1 to 19 and/or the method according to any one of claims 20 to 38.
65. The method according to any one of claims 1 to 64, wherein said method is performed under conditions where the penis is in a flaccid non-erect state.
66. The method according to any one of claims 1 to 65, wherein said method is performed under conditions where the penis is in an erect state.
67. The method according to any one of claims 10,26 or 51, wherein sculpting the injected filler composition in the subject’s penis to a desired shape is performed manually.
68. The method according to any one of claims 15, 32 and 59, wherein the nerve blocker is an analgesic.
69. 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.
70. The method as claimed in Claim 69 wherein the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen.
71. A method of widening a penis substantially as herein described.
72. 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.
73. The method of Claim 72 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 inffapubically.
74. The method of Claim 73 wherein the number of the additional sutures inserted is 1 or more.
75. The method of Claim 74 wherein the number of the additional sutures is determined by the width of the symphysis pubis.
76. The method of any of Claims 72 to 75 including the step of dividing the fundiform ligament prior to the step of drawing the skin of the junction site of the scrotum.
77. 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.
78. A method as claimed in Claim 77 wherein the dermal fat grafts are harvested from either the buttocks, lower back or lower abdomen.
79. A method of lengthening and widening a penis, the lengthening using the method as claimed in Claim 72 and the widening using the method as claimed in Claim 69 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.
80. A method of lengthening the penis of a male substantially as herein described.
81. A method of widening a penis substantially as herein described.
82. A method of lengthening and widening a penis substantially as herein described.
83. 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 coipus cavernosum; dividing the first and second corpus cavernosum circumferentially; the method further including the step of following a post-operative treatment regime.
84. The method as claimed in claim 83 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.
85. The method as claimed in claim 83 or claim 84 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 coipus was performed earlier in the procedure.
86. A method as claimed in claim 84 wherein the increase in length of the corporal cylinder is of the order of one or more cm.
87. A method as claimed in any one of claims 83 to 86 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.
88. A method as claimed in claim 87 wherein the dermo epidermal surface is the inner most surface applied to the corporal cavity.
89. A method of enhancement phalloplasty as claimed in any one of claims 83 to 88 wherein widening of the penis is also required and wherein widening is effected by using a dermal fat graft.
90. The method of claim 89 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.
91. A method of enhancement phalloplasty as claimed in claim 90 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.
92. A method of enhancement phalloplasty as claimed in claim 91 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.
93. A method as claimed in any one of claims 83 to 92 further including an additional step wherein the degloved penis is reduced and the proximal wounds are trimmed and closed in layers.
94. A method of lengthening and widening a penis, the lengthening using the method as claimed in any one of claims 69 to 93 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.
95. A method of enhancement phalloplasty substantially as hereinbefore described with reference to the examples of the particular operations given in the specification.
96. A method for penile enlargement further including the step of application of a postoperative treatment regime thereby to maintain outcome of enlargement.
97. A method of penile enlargement further including the step of application of a postoperative treatment regime.
98. The method of claims 96 or 97 wherein penile enlargement comprises one or more of lengthening or widening.
99. The method of any previous claim further including the step of treatment for buried penis condition.
100. The method of any previous claim wherein the post-operative treatment regime comprises application of a drug treatment regime.
101. The method of any previous claim wherein the post-operative treatment regime comprises application of an exercise regime.
102. An exercise regime for application following application of the method of any previous claim.
103. A drug treatment regime for application following application of the method of any one of claims 69 to 101.
104. 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.
105. The method of claim 104 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.
106. The method of any one of Claims 104 or 105 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.
107. 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. 10 8. A method of widening a penis substantially as herein described.
109. 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.
110. A method of lengthening and widening a penis, the lengthening using the method as claimed in any one of Claims 72 to 78 and the widening using the method as claimed in Claim 109 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.
111. A method as claimed in any one of claims 83 to 86 wherein a gap formed in the first or second corpus cavernosum is filled by suturing in place an acellular matrix graft.
112. A method of enhancement phalloplasty as claimed in any one of claims 83 to 86 wherein widening of the penis is also required and wherein widening is effected by using an acellular matrix graft.
113. The method of any one of claims 107,109, 110, 111,112 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 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 cavernosum without dividing the graft as a separate phenomenon.
114. A method of enhancement phalloplasty as claimed in claim 113 wherein if the patient has a very thickened wall of the first or second corpus cavernosum, 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.
115. A method of enhancement phalloplasty as claimed in claim 114 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 acellular matrix graft is applied.
116. A drug treatment regime for application following application of the method of any one of claims 107 to 115.
117. A method of lengthening 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 administering to the patient a post-operative drug treatment regime to (a) control or prevent bacterial penile wound infection, and/or (b) suppress penile erection, and/or (c) prevent or reduce penile tissue swelling.
118. The method of claim 117, 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.
119. The method of claim 117 or 118, 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.
120. The method of any one of claims 117 to 119, 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.
121. The method of claim 120, wherein the number of said additional sutures inserted is 1 or more.
122. The method of claim 120 or claim 121, wherein the number of said additional sutures is determined by the width of the symphysis pubis.
123. The method of any one of claims 117 to 122, including dividing the fundiform ligament prior to drawing the skin of the junction site of the scrotum.
124. The method of any one of claims 117 to 123, further including suturing a dermal fat graft to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.
125. The method of claim 124, wherein the dermal fat graft has been harvested from either buttocks, lower back or lower abdomen.
126. The method of any one of claims 117 to 125, wherein said 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, 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 cavemosum; and dividing said first and second corpus cavemosum circumferentially.
127. The method of claim 126, wherein 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 first and second corpus cavemosum to be elongated without dividing the coipus spongiosum.
128. The method of claim 126 or claim 127, 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.
129. The method of claim 128, wherein the increase in length of the corporal cylinder is of the order of one or more cm.
130. The method of any one of claims 126 to 129, including filling a gap formed in the first or second corpus cavernosum by suturing in place an inverted dermal graft from which epidermis has been removed.
131. The method of claim 130, wherein suturing in place the inverted dermal graft from which epidermis has been removed comprises applying to a corporal cavity of said penis a dermo epidermal surface of said inverted dermal graft, wherein said dermo epidermal surface is the innermost surface of said dermal graft applied to a corporal cavity of said penis.
132. The method of any one of claims 126 to 131, including: suturing a dermal fat 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 coipus cavernosum without dividing the graft as a separate phenomenon.
133. The method of claim 132, wherein when the patient has a thickened wall of the first or second corpus cavernosum, said method includes placing a first dermal fat graft into the defect in the Buck’s fascia and then placing a second dermal fat graft into the defect superficial to said first dermal fat graft.
134. The method of claim 133, wherein when the patient has a thickened wall of the coipus 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 dermal fat graft.
135. The method according to any one of claims 126 to 134, further including reducing the degloved penis, trimming the proximal wounds and closing the proximal wounds in layers.
136. The method according to any one of claims 117 to 135, including: excising from the patient a dermal fat graft comprising a block of fat and attached dermis; degloving the penis; and suturing the dermal fat graft to the exposed Bucks fascia prior to the tying of the sutures which maintain the lengthening of the penis.
137. The method according to any one of claims 69 to 117, 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) ketoconazole; (v) a combination of paracetamol, codeine and doxylamine succinate; and (vi) prednisone.
138. The method of claim 137, wherein the method comprises administering to the patient orally: (i) cephalexin monohydrate at a dosage of 500mg, three times a day for 14 days; (ii) a combination of amoxycillin trihydrate and clavulanic acid at a dosage of 875mg of amoxycillin and 125 mg of clavulanic acid, twice a day for 14 days; (iii) alprazolam at a dosage between 0.5 mg to 1.0 mg, three times a day for 14 days; (iv) Ketoconazole at a dosage of 400mg, three times a day for 14 days; (v) a combination of paracetamol, codeine phosphate and doxylamine succinate at a dosage of 900 mg of paracetamol, 60mg of codeine phosphate and lOmg of doxylamine succinate once a night for 14 nights; and/or (vi) prednisone at a dosage 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.
139. The method according to any one of claims 117 to 138, further including performing a treatment for buried penis condition and/or performing by the male patient postoperative penile scar stretching exercises.
140. 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.
141. The method according to any one of claims 1 to 68, further comprising performing the method according to any one of claims 69 to 140.
142. The method according to any one claims 69 to 140, further comprising performing the method according to any one of claims 1 to 68.