Penile Implant Device and Method

Abstract

A penile implant enhancement device and method is provided. The penile implant device comprises an elongated cylindrical sleeve that is configured to encircle a shaft of a penis and an external layer. The elongated cylindrical sleeve is defined by one or more edges, surfaces, or layers, including a proximal edge, a distal edge, a first side, a second side, a top surface, and a bottom surface, and the external layer is configured to cover the one or more edges, surfaces, or layers of the sleeve to form one or more covered edges, surfaces, or layers. The covered edges, surfaces, or layers are configured to align with the penis. The method comprises the steps of administering one or more anesthetic agents; cutting a transverse incision above the pubic symphysis; clamping a lower edge of the transverse incision; dissection through the one or more layers of subcutaneous tissue to expose tunica albuginea; everting the penis; creating a pocket between the tunica albuginea and the skin; providing the aforementioned penile implant device; suturing the covered edges, surfaces, or layers to the penis; trimming the external layer, reverting the penis; and closing the transverse incision.

Claims

1. A penile implant device, comprising: an elongated cylindrical sleeve that is configured to encircle a shaft of a penis, the elongated cylindrical sleeve defined by one or more edges, surfaces, or layers; and an external layer configured to cover the one or more edges, surfaces, or layers of the elongated cylindrical sleeve and align with the penis.

2. The penile implant device of claim 1, wherein the elongated cylindrical sleeve is further defined by a plurality of hingedly joined sides abutting along one or more hinges.

3. The penile implant device of claim 2, wherein the plurality of sides comprise a first side and a second side abutting along a hinge.

4. The penile implant device of claim 3, wherein the one or more edges, surfaces, or layers comprise a distal edge configured to align with a coronal sulcus of the penis, a proximal edge configured to align with a base of the penis, a first lateral edge disposed along the first side opposite the hinge, a second lateral edge disposed along the second side opposite the hinge, a top surface, and a bottom surface.

5. The penile implant device of claim 4, wherein the external layer covers the distal edge of the elongated cylindrical sleeve to form a covered distal edge configured to align with the coronal sulcus of the penis.

6. The penile implant device of claim 3, wherein the elongated cylindrical sleeve further comprises a press-rib, and wherein the first side and the second side rotate around the hinge outwardly and the press-rib presses a deep dorsal vein of the penis during penile erection.

7. The penile implant device of claim 3, wherein the first side and the second side rotate around the hinge inwardly during penile flaccidity.

8. The penile implant device of claim 1, wherein the elongated cylindrical sleeve is formed of a gel-like material, saline, marbles, or one or more internal layers formed of one or more of medical-grade silicone, polyester, and one or more air pockets.

9. The penile implant device of claim 1, wherein the elongated cylindrical sleeve and the external layer are contiguously joined.

10. The penile implant device of claim 1, wherein the elongated cylindrical sleeve and the external layer are separate and are configured to be joinable along the one or more edges, surfaces, or layers of the sleeve.

11. The penile implant device of claim 1, wherein the external layer is formed of polypropylene, silicone, bovine tissue, or other biocompatible material.

12. A penile implant method, comprising the steps of: administering one or more anesthetic agents to a patient having a penis; cutting an at least ¼-inch transverse incision above pubic symphysis; clamping a lower edge of the transverse incision to expose one or more layers of subcutaneous tissue; dissecting through the one or more layers of subcutaneous tissue to expose tunica albuginea; everting the penis; creating a pocket between the tunica albuginea and the skin; providing a penile implant device defined by an elongated cylindrical sleeve and an external layer covering one or more edges, surfaces, or layers of the sleeve to form one or more covered edges, surfaces, or layers; suturing the one or more covered edges, surfaces, or layers to the penis; trimming the external layer; reverting the penis; and closing the incision.

13. The penile implant method of claim 12, wherein the anesthetic agent comprises at least one of a general anesthetic agent, a general twilight anesthetic agent, a spinal anesthetic agent, and a local anesthetic agent.

14. The penile implant method of claim 12, wherein dissecting through the one or more layers of subcutaneous tissue to expose tunica albuginea further comprises electrocauterizing and cutting the one or more layers of subcutaneous tissue; and releasing subcutaneous tissue from the suspensory ligament.

15. The penile implant method of claim 12, wherein the elongated cylindrical sleeve and the external layer are contiguously joined.

16. The penile implant method of claim 12, wherein the elongated cylindrical sleeve and the external layer are separate and are configured to be joinable along one or more edges, surfaces, or layers of the sleeve.

17. The penile implant method of claim 12, wherein the external layer covers a distal edge of the elongated cylindrical sleeve and the one or more covered edges, surfaces, or layers comprise a covered distal edge.

18. The penile implant method of claim 12, wherein suturing the one or more covered edges, surfaces, or layers to the penis further comprises positioning a longitudinal midline of the penile implant device along a dorsal longitudinal midline of the penis; and suturing two or more surgical sutures to attach the device to the tunica albuginea.

19. The penile implant method of claim 18, wherein the two or more surgical sutures are polyester sutures.

20. A penile implant device, comprising: an elongated cylindrical sleeve that is configured to encircle a shaft of a penis, the elongated cylindrical sleeve defined by a proximal edge, a distal edge, a first side, a second side, and a hinge, wherein the first side and the second side abut along the hinge; and an external layer covering the distal edge of the elongated cylindrical sleeve to form a covered distal edge, the covered distal edge configured to align with a coronal sulcus of the penis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] FIG. 1 shows a perspective view of an embodiment of the penile implant device.

[0038] FIG. 2 shows a cross-sectional view of an embodiment of the penile implant device.

[0039] FIG. 3 shows a cross-sectional view of an embodiment of the penile implant device.

[0040] FIG. 4 shows a perspective view of an embodiment of the penile implant device.

[0041] FIG. 5 shows an exploded perspective view of an embodiment of the penile implant device.

[0042] FIG. 6 shows an embodiment of the penile implant method.

[0043] The disclosed embodiments may be better understood by referring to the figures in the attached drawings, as provided below. The attached figures are provided as non-limiting examples for providing an enabling description of the method and system claimed. Attention is called to the fact, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered as limiting of its scope. One skilled in the art will understand that the invention may be practiced without some of the details included in order to provide a thorough enabling description of such embodiments. Well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0044] For simplicity and clarity of illustration, the drawing figures illustrate the general manner of construction, and descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the invention. Additionally, elements in the drawing figures are not necessarily drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of embodiments of the present invention. The same reference numerals in different figures denote the same elements.

[0045] The terms “first,” “second,” “third,” “fourth,” and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Furthermore, the terms “include,” and “have,” and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, device, or apparatus that comprises a list of elements is not necessarily limited to those elements, but may include other elements not expressly listed or inherent to such process, method, system, article, device, or apparatus

[0046] The terms “couple,” “coupled,” “couples,” “coupling,” and the like should be broadly understood and refer to connecting two or more elements or signals, electrically, mechanically or otherwise. Two or more electrical elements may be electrically coupled, but not mechanically or otherwise coupled; two or more mechanical elements may be mechanically coupled, but not electrically or otherwise coupled; two or more electrical elements may be mechanically coupled, but not electrically or otherwise coupled. Coupling (whether mechanical, electrical, or otherwise) may be for any length of time, e.g., permanent or semi-permanent or only for an instant.

DETAILED DESCRIPTION

[0047] Having summarized various aspects of the present disclosure, reference will now be made in detail to that which is illustrated in the drawings. While the disclosure will be described in connection with these drawings, there is no intent to limit it to the embodiment or embodiments disclosed herein. Rather, the intent is to cover all alternatives, modifications and equivalents included within the spirit and scope of the disclosure as defined by the appended claims.

[0048] A penile implant device and method is provided that, in some embodiments, may cause enhanced penile appearance while avoiding adverse changes in sexual and other functions. In addition to cosmetically correcting the penis, the penile implant device may improve a patient's self-confidence, self-esteem, and overall self-satisfaction. The penile implant device may comprise an elongated cylindrical sleeve configured to encircle a shaft of a penis and an external layer configured to align with and secure to the tunica albuginea of the penis.

[0049] While the device and method is described herein as comprising only the elongated cylindrical sleeve and the external layer, either together or as separate components, a person of ordinary skill in the art will recognize that the invention discussed herein should not be limited to the specific exemplary embodiments provided. Indeed, the elongated cylindrical sleeve may comprise a plurality of hingedly joined sides 116a, 116b. In other embodiments (not shown), the elongated cylindrical sleeve may comprise a unitary body. However, in embodiments illustrated in the FIGS. herein, the elongated cylindrical sleeve 110 may comprise a first side 116a and a second side 116b disposed along one hinge 118. Moreover, the external layer 120 may comprise one or more of external layers that may be configured to align with one or more edges, surfaces, or layers of the sleeve. As shown herein, the external layer 120 may be configured to align with a distal edge 114 of the sleeve 110.

[0050] More particularly, according to one embodiment shown FIG. 1, the elongated cylindrical sleeve 110 may be defined by a proximal edge 112, the distal edge 114, a top surface 113a, a bottom surface 113b, the first side 116a and the second side 116b. In certain embodiments, the proximal edge 112 of the sleeve 110 may correspond to a proximal edge of the penis, that is, the edge closest to a base of the penis and the patient's torso. Similarly, the distal edge 114 of the sleeve 110 may correspond to a distal edge of the penis, that is, the edge closest to the glans penis and furthest from the patient's torso. In other words, the proximal edge 112 of the sleeve 110 may align with a base of the penis while the distal edge 114 of the sleeve 110 may align with the coronal sulcus along the glans penis. Moreover, the top surface 113a may correspond to a dorsal side of the penis, while the bottom surface 113b may correspond to the ventral side of the penis. Thus, the bottom surface 113b may contact and align with the dorsal side of the penis while the top surface 113a may remain exposed. In some embodiments, the proximal edge 112 may remain unattached to the penis and therefore, may freely expand and contract during erection, intercourse, and flaccidity. In alternate embodiments, the proximal edge 112 may secure to the penile base.

[0051] Referring now to FIGS. 2-3, the first side 116a and the second side 116b of the elongated cylindrical sleeve 110 may be joined together along the hinge 118. The hinge 118 may be disposed along a longitudinal midline of the sleeve 110 such that the first side 116a may be positioned along one half of the midline while the second side 116b may be positioned complimentarily along the other half of the midline. The first side 116a and the second side 116b may be further defined by a first lateral edge 117a and a second lateral edge 117b, respectively. The first and second lateral edges 117a, 117b may be positioned opposite the longitudinal midline of the sleeve 110 and therefore, the hinge 118. Indeed, in some embodiments, the hinge 118 may be equidistant between the first lateral edge 117a and the second lateral edge 117b. Moreover, the first lateral edge 117a may run parallel to the second lateral edge 117b. In certain embodiments, the first lateral edge 117a may contact, but not secure to, the second lateral edge 117b.

[0052] According to certain embodiments, such as that shown in FIG. 2, when the penis is erect, the first side and the second side 116a, 116b may rotate outwardly, that is, in an open direction, around the hinge 118. Indeed, in such embodiments, the penis may require greater space to expand while engorging with blood. In these embodiments, the first lateral edge 117a may move further apart from the second lateral edge 117b. On the other hand, as shown in FIG. 3, when the penis is flaccid, the first side and the second side 116a, 116b may rotate inwardly, that is, in a closed direction, around the hinge 118. In such embodiments, the first lateral edge 117a may move closer toward the second lateral edge 117b. In further flaccid embodiments, the first lateral edge 117a may contact the second lateral edge 117b.

[0053] In some embodiments, such as that shown in FIGS. 2-3, the elongated cylindrical sleeve 110 may also comprise a press-rib 115 disposed along a bottom surface of the sleeve 110 along the longitudinal midline. Indeed, the press-rib 115 may be disposed opposite the hinge 118 along the longitudinal midline of the sleeve 110. While the press-rib 115 is shown in FIGS. 2-3 as extending the entire length of the longitudinal midline, in other embodiments, the press-rib 115 may extend only partially the length of the longitudinal midline. Moreover, the press-rib 115 is also shown as having a teardrop or semi-circular shape, but the press-rib 115 may be formed into other shapes as well, such as a triangle or any other convenient or desirable shape. In embodiments wherein the penis may be erect or becoming erect, as shown in FIG. 2, the press-rib 115 may be forced downward against the deep dorsal vein of the penis, thereby preventing reverse blood flow and further, maintaining the erection.

[0054] Referring back to FIG. 1, the elongated cylindrical sleeve 110 may be configured to comfortably encircle a shaft of a penis. In some embodiments, including in those wherein the penis may be flaccid, the elongated cylindrical sleeve 110 may wholly encircle the penile shaft. In other embodiments, including in those wherein the penis may be erect, the elongated cylindrical sleeve 110 may only partially encircle the penile shaft. As such, the sleeve 110 may be formed as either a full cylinder shape or a partially opened cylinder shape.

[0055] According to certain embodiments, the elongated cylindrical sleeve 110 may comprise medical-grade silicone and medical-grade polyester. In other embodiments, the sleeve 110 may be formed out of a combination of medical-grade silicone and medical-grade polyester. In still other embodiments, as understood by a person of ordinary skill, the sleeve 110 may be formed out of other medical-grade materials. In further embodiments, the elongated cylindrical sleeve 110 may comprise a gel-like material, saline, marbles, or other materials. In some embodiments, the elongated cylindrical sleeve 110 may comprise a stretchable material. For example, the stretchable material may comprise an accordion stretch material or a spring-like material. In certain further embodiments, the sleeve 110 may be smooth. In alternate embodiments, the sleeve 110 may be textured or may comprise one or more grooves, patterns, lines, shapes, symbols, or textures.

[0056] Moreover, in certain embodiments (not shown), the sleeve 110 may comprise one or more internal layers. The one or more internal layers may be formed of mesh or other materials. In such embodiments, the one or more layers may provide desirable rigidity. In alternate embodiments, the one or more layers may be formed of a stretchable material. As before, the stretchable material may comprise any stretchable material, such as the accordion stretch material or spring-like material. In other embodiments, the one or more internal layers may be formed of one or more air pockets.

[0057] Further, in some embodiments, the elongated cylindrical sleeve 110 may be formed of one or more of an antimicrobial material, an antibacterial material, or an antibiotic material. Moreover, in other embodiments, the elongated cylindrical sleeve 110 may comprise one or more antimicrobial layers or one or more antibiotic layers. In some of these embodiments, the one or more antimicrobial or antibiotic layers may be embedded or impregnated within the sleeve 110. In other embodiments, the one or more antimicrobial or antibiotic layers may be secured to one or more edges, surfaces, or layers of the sleeve 110 while the sleeve 110 is implanted within the patient's penis.

[0058] Further, while the elongated cylindrical sleeve 110 has been described as being formed as a cylinder, the sleeve 110 may vary in size, such as length and width, and shape. For instance, in certain embodiments, the size of the sleeve 110 may vary depending on the natural size and shape of the patient's penis. Alternatively, the size of the sleeve 110 may vary depending on the recommendation of the physician or the desires of the patient. Moreover, in some embodiments (not shown), the elongated cylindrical sleeve 110 may comprise a plurality of segments along its length, that is, from the proximal edge 112 to the distal edge 114. In this manner, the plurality of segments may provide further customization of the shape of the device 100 so as to suit the individual needs of the patient.

[0059] With reference now to FIGS. 4-5, the external layer 120 may be configured to cover the sleeve 110. Thus, in some embodiments, the external layer 120 and the sleeve 110 may be formed as separate pieces. In this way, the external layer 120 may be formed as a sheet or any other convenient shape. Moreover, as shown in the FIGS., the external layer 120 may be formed out of a soft mesh material so as to allow the layer 120 to easily cover the sleeve 110. For example, in some embodiments, the external layer 120 may be formed out of polypropylene, silicone, bovine tissue, marbles, or strings. One of ordinary skill in the art will appreciate that the external layer 120 may be formed out of other medically-safe, biocompatible materials as well. In other embodiments, the external layer 120 may be formed out of non-biocompatible materials and may be formed into various shapes as well.

[0060] Further, similar to the elongated cylindrical sleeve 110, the external layer 120 may be formed of one or more of an antimicrobial material, an antibacterial material, or an antibiotic material. In alternate embodiments, the external layer 120 may comprise one or more antimicrobial layers and/or one or more antibiotic layers. In certain embodiments, the one or more antimicrobial layers and/or the one or more antibiotic layers may be secured to the external layer 120 prior to or concurrent with the external layer 120 being secured to the elongated cylindrical sleeve 110. In other embodiments, the one or more antimicrobial layers and/or the one or more antibiotic layers may be secured to the external layer 120 after the external layer has been secured to the elongated cylindrical sleeve 110.

[0061] More particularly, according to some embodiments, the external layer 120 may be defined by a midline 122. As shown in FIG. 5, the midline 122 may join to and cover the distal edge 114 of the sleeve 110 so as to form a covered distal edge 124. Once the external layer 120 has covered the distal edge 114 of the sleeve 110, the covered distal edge 124 may align with a coronal sulcus of the penis. In further embodiments, the covered distal edge 124 may secure to the coronal sulcus, thereby securing the device 100 to the penis. For instance, the covered distal edge 124 may be secured to the coronal sulcus using one or more nonabsorbable surgical sutures. In certain exemplary embodiments, the one or more nonabsorbable surgical sutures may comprise polyester sutures or any other appropriate sutures, as known to those skilled in the art.

[0062] In alternate embodiments, as shown in FIG. 4, the external layer 120 and the elongated cylindrical sleeve 110 may form a single-bodied penile implant device 100. In such embodiments, the external layer 120 and the elongated cylindrical sleeve 110 may not be separate pieces. Instead, in these embodiments, the external layer 120 may be contiguously joined with the sleeve 110. Further, both or either of the external layer 120 or sleeve 110 may comprise one or more anchor points. The one or more anchor points may allow for suturing of the device 100 to the tunica albuginea of the penis.

[0063] With reference to FIG. 6, one embodiment of the present invention may involve a method of implanting the aforementioned penile implant device. FIG. 6 illustrates a flowchart of one embodiment of the method of this invention. The method may improve penile appearance by cosmetically correcting conditions such as small penis perception, buried penis, micropenis, and other related diagnoses. In particular, the method may provide additional girth and length of the penis outside of the patient's body. In certain embodiments, including that demonstrated in FIG. 6, the method may comprise the steps of: administering one or more anesthetic agents to a patient having a penis (block 601); cutting an at least ¼-inch transverse incision above pubic symphysis (block 602); clamping a lower edge of the transverse incision to expose one or more layers of subcutaneous tissue (block 603); dissecting through the one or more layers of subcutaneous tissue to expose tunica albuginea (block 604); everting the penis (block 605); creating a pocket between the tunica albuginea and the skin (block 606); defining the coronal sulcus (block 607); providing a penile implant device defined by an elongated cylindrical sleeve and an external layer covering one of one or more edges, surfaces, or layers of the sleeve to form one or more covered edges, surfaces, or layers (block 608); suturing the one or more covered edges, surfaces, or layers to the penis (block 609); trimming the external layer (block 610); reverting the penis (block 611); and closing the incision (block 612).

[0064] Initially, the one or more anesthetic agents may be administered (block 601). The one or more anesthetic agents may render the patient unconscious or otherwise alter or reduce the patient's conscious state, sensation and perception of pain resulting from the procedure. In some embodiments, the one or more anesthetic agents may comprise general anesthesia or spinal anesthesia. In further embodiments, the one or more anesthetic agents may comprise general twilight anesthesia. In these embodiments, the general anesthesia may be administered in a mild dose so as to cause mild sedation and anxiolysis. In other embodiments, the one or more anesthetic agents may comprise a local anesthetic agent. For instance, the one or more anesthetic agents may be injected around the base of the penis. In such embodiments, the one or more anesthetic agents may comprise the local anesthetic agent, such as lidocaine, other long-acting local anesthetic agents, or combinations thereof.

[0065] Once the one or more anesthetic agents have been administered (block 601), the at least ¼-inch transverse incision may be cut two to three centimeters above the pubic symphysis so as to allow access to the penis (block 602). Stated differently, the at least ¼-inch transverse incision may be cut approximately one inch above the suprapubic bone. In some embodiments, the at least ¼-inch transverse incision may be 2-inches. The transverse incision may comprise an upper edge and a lower edge. Moreover, Dartos fascia may be exposed as a result of cutting the transverse incision. Indeed, in many embodiments, the transverse incision may be cut only as deep as Dartos fascia.

[0066] After the at least ¼-inch transverse incision has been cut (block 602), the lower edge of the transverse incision may be clamped to expose the one or more layers of subcutaneous tissue (block 603). One or more Allis clamps may be used to clamp the transverse incision. One or more Allis clamps may be operative to withstand and retain the weight of heavy tissue. More specifically, in some embodiments, two Allis clamps may be used to clamp the lower edge of the transverse incision. In alternate embodiments, other surgical instruments may be used to clamp, hold, or grasp the lower edge. For instance, another surgical clamp, a tenaculum, or Cushing forceps may be used to clamp the lower edge of the incision.

[0067] Next, the one or more layers of subcutaneous tissue may be dissected through to expose tunica albuginea (block 604). According to certain embodiments, scissors, an electrocautery, a combination of scissors or electrocautery may be used to dissect through the subcutaneous tissue. In other embodiments, alternate surgical dissecting instruments may be used to dissect. In further embodiments, dissecting through the one or more layers of subcutaneous tissue may further comprise releasing tissue from the suspensory ligament of the penis without removing attachment of the suspensory ligament altogether.

[0068] A pocket may be created between the tunica albuginea and the skin in order to provide space for the penile implant device (block 606). In certain embodiments, the pocket may comprise the entire length of the penile shaft from the proximal edge at the base to the distal edge at the glans penis. In others, the pocket may only comprise a partial length of the penile shaft. In some embodiments, the pocket may comprise a ¾ circumferential dissection around the penile shaft.

[0069] According to some embodiments, creating a pocket between the tunica albuginea and the skin may comprise creating a pocket between Buck's fascia and Dartos fascia. The pocket between Buck's fascia and Dartos fascia may extend the entire length of the penile shaft. In other words, the pocket may extend from a proximal edge of the penile shaft to the glans penis.

[0070] Following creation of the pocket, in some embodiments wherein the device may attach to a distal edge of the penis, the coronal sulcus may be defined (block 607). Defining the coronal sulcus of the penis may further comprise sharply dissecting the tissue around the coronal sulcus. In some embodiments, the coronal sulcus may comprise areolar tissue attached thereto. In such embodiments, defining the coronal sulcus may further comprise releasing the areolar tissue. Defining the coronal sulcus of the penis may provide access to the glans penis for subsequent suturing of the penile implant device.

[0071] In some embodiments, the elongated cylindrical sleeve and the external layer may be contiguously joined in that the sleeve and the external layer may form a single-bodied device. Alternatively, the elongated cylindrical sleeve and the external layer may be separate and may be configured to be joinable along the one or more edges, surfaces, or layers of the sleeve. For example, in certain embodiments, the external layer may be joinable along the distal edge of the sleeve. In such embodiments, providing the penile implant device (block 608) may further comprising providing the sleeve and the external layer and subsequently covering the external layer over the distal edge of the sleeve to form the covered distal edge. In still other embodiments, providing the penile implant device (block 608) may comprise providing the sleeve and the external layer, covering the external layer over the distal edge of the sleeve, and securing, such as by suturing, the external layer to the distal edge of the sleeve.

[0072] The one or more covered edges, surfaces, or layers may then be sutured to the penis (block 609). In certain exemplary embodiments, wherein the one or more covered edges, surfaces, or layers is a covered distal edge, the covered distal edge may be sutured to the coronal sulcus of the penis. Suturing the covered edges, surfaces, or layers to the edge of the penis may further comprise positioning a longitudinal midline of the penile implant device along a dorsal longitudinal midline of the penis and suturing to attach the device to the tunica albuginea. According to some embodiments, nonabsorbable surgical sutures may be used for suturing the covered edges, surfaces, or layers to the penis. In particular, the nonabsorbable surgical sutures may be secured to the tunica albuginea. In alternate embodiments, the surgical sutures may comprise polyester, silk, nylon, stainless-steel, or a combination of the foregoing. In still other embodiments, the one or more covered edges, surfaces, or layers may be sutured to the penis using absorbable surgical sutures. In certain embodiments, two or more surgical sutures may be used to secure the penile implant device to the tunica albuginea of the penis.

[0073] Finally, the external layer maybe trimmed (block 610), the penis may be reverted (block 611), and the transverse incision may be closed (block 612). Scissors or other surgical cutting instruments may be used to trim the external layer (block 610). In alternate embodiments, other instruments may be used as well. In certain exemplary embodiments, the external layer may be trimmed so as to leave a one-centimeter edge around each of the sutures. Closing the transverse incision (block 612) may comprise suturing the lower edge of the transverse incision to the upper edge of the transverse incision. In other embodiments, the lower edge of the transverse incision may be glued or otherwise secured to the upper edge of the transverse incision.

[0074] In certain further embodiments, the method may comprise one or more additional steps. In some embodiments, the method may further comprise preparing a surgical site. Preparing the surgical site may take place prior to or immediately following administering the one or more anesthetic agents. The surgical site may comprise the penis and the adjacent bodily area. Preparing the surgical site may comprise draping the surgical site with an antimicrobial drape. The antimicrobial drape may inhibit bacterial growth at the surgical site by immobilizing bacteria and providing antimicrobial activity. Preparing the surgical site may also comprise measuring preoperative penile circumference and length.

[0075] Throughout the method, in further embodiments, one or more antibiotics may be applied. Applying the one or more antibiotics may further comprising irrigating or lavaging the surgical site with the one or more antibiotics. The one or more antibiotics may comprise a triple antibiotic solution mixed with rifampicin. In other embodiments, the one or more antibiotics may comprise a triple antibiotic solution mixed with minocycline. A person of ordinary skill in the art will understand that the one or more antibiotics may comprise other known antibiotic compositions as well.

[0076] Following the method, a surgical drain may be installed. According to certain embodiments, a Jackson-Pratt drain may be installed. In other embodiments, the surgical drain may comprise a Penrose drain, a Redivac drain, negative pressure wound therapy, a Davol, a pigtail drain, or any other surgical instrument operative to remove collected fluid from the surgical site. The surgical drain may render less likely the possibility of infection and other complications resulting from commonly-occurring fluid build-up at the surgical site by removing the fluid.

[0077] It should be emphasized that the above-described embodiments are merely examples of possible implementations. Many variations and modifications may be made to the above-described embodiments without departing from the principles of the present disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

[0078] Moreover, embodiments and limitations disclosed herein are not dedicated to the public under the doctrine of dedication if the embodiments and/or limitations: (1) are not expressly claimed in the claims; and (2) are or are potentially equivalents of express elements and/or limitations in the claims under the doctrine of equivalents.

CONCLUSIONS, RAMIFICATIONS, AND SCOPE

[0079] While certain embodiments of the invention have been illustrated and described, various modifications are contemplated and can be made without departing from the spirit and scope of the invention. For example, the elongated cylindrical sleeve and the external layer may be provided separately or as a single-bodied device. As another example, the external layer may cover the one or more edges, surfaces, or layers of the elongated cylindrical sleeve. Accordingly, it is intended that the invention not be limited, except as by the appended claims.

[0080] The teachings disclosed herein may be applied to other systems and may not necessarily be limited to any described herein. The elements and acts of the various embodiments described above can be combined to provide further embodiments. All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions and concepts of the various references described above to provide yet further embodiments of the invention.

[0081] Particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being refined herein to be restricted to any specific characteristics, features, or aspects of the penile implant device and method with which that terminology is associated. In general, the terms used in the following claims should not be constructed to limit the penile implant device and method to the specific embodiments disclosed in the specification unless the above description section explicitly define such terms. Accordingly, the actual scope encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the disclosed system, method and apparatus. The above description of embodiments of the penile implant device and method is not intended to be exhaustive or limited to the precise form disclosed above or to a particular field of usage.

[0082] While specific embodiments of, and examples for, the method, system, and apparatus are described above for illustrative purposes, various equivalent modifications are possible for which those skilled in the relevant art will recognize.

[0083] While certain aspects of the method and system disclosed are presented below in particular claim forms, various aspects of the method, system, and apparatus are contemplated in any number of claim forms. Thus, the inventor reserves the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the penile implant device and method.