Technical Field of the Invention

The present invention relates to a malleable penile implant. The penile implant comprises a malleable core surrounded by a soft material, usually molded silicon.

Background of the Invention A malleable penile implant is a surgical device that allows an impotent male to have an erection. The malleable implant consists of two cylinders that are always hard but still pliable by the patient. All components are concealed within the body and cannot be seen from the outside. Since the patient is implanted with two cylinders or cores, each cylinder or core shall act in the same manner when bent by the patient. However, this is not the case in real life as the two cores tend to move in different directions when bent or erected.

US 4 988 357 discloses a malleable penile implant with a core including a plurality of metallic wires, typically high-purity silver. Silver as the wire material is prone to fractures upon a number of manually bringing the implant to alternating erected (straight) and bent conformations, which corresponds to a relatively short service life. Furthermore, high purity silver is a costly material causing high material costs in obtainment of the respective implant. US 5 512 033 discloses a malleable penile implant with a core including a high number of wires, wherein steel is preferred as the wire material over silver, tantalum, an alloy of titanium, aluminum and vanadium, and chromium-nickel super alloy. Ends of the core are individually fixed into the body surrounding the core, which corresponds to high labor costs.

The malleable penile implant cylinders reside in the penis on either side of the same. No tissue is removed to place the two malleable cylinders as the cylinders simply occupy spaces that were previously filled with blood. The two cylinders do neither disrupt the flow of urine or ejaculate, nor alter the sensation of the penis. The cylinders also do not change the shape of tumescence of the head of the penis.

An implant is introduced to the body of a patient through a surgical operation, which can be painful and requires a recovery time until the end of which full and comfortable function of the respective body part is not available. Therefore it is desired to provide a reliable implant having an acceptably long service life.

Penile implants in the market generally include a high number of interrelated movable parts, some of which being highly delicate. Provision of acceptably long service life to such delicate parts is inherently a difficult and expensive issue.

Objects of the Invention

Primary object of the present invention is to overcome the abovementioned shortcomings of the prior art.

A primary object of the present invention is to provide a penile implant, which when implanted as a pair, each cylinder of the pair acts alike to each other when bent or erected by the patient.

Another object of the present invention is to provide a low cost penile implant.

A further object of the present invention is to provide a penile implant with an enhanced service life.

Summary of the Invention

The present invention proposes a penile implant comprising a core inside a flexible body, the core comprising a first end and a second end distal to the first end with respect to a main central axis, wherein the core further comprises an elongate part made of a bendable material, each of the first end and second end include one or more passage(s) each having two or more openings, each passage surrounding a bridge of the material forming the flexible body essentially occupying the space between said openings of respective passage(s). Brief Description of the Figure

The figures, whose brief explanation is herewith provided, are solely intended for providing a better understanding of the present invention and are as such not intended to define the scope of protection or the context in which said scope is to be interpreted in the absence of the description.

Figure 1 shows side view of an exemplary penile implant according to the present invention.

Figure 2a schematizes a straight conformation of the penile implant according to the present invention, A-A section of the embodiment shown in Fig. la.

Figure 2b is a detailed view of the zone (E) in Fig.2a, emphasizing how a cap is received by a corresponding guiding means in a maximum extent at the straight conformation; here, the cap is essentially retracted into the guiding means.

Figure 2c schematizes a bent conformation of the penile implant according to the present invention which is shown in Fig.2a.

Figure 2d is a detailed view of the zone (F) in Fig.2c, emphasizing how a cap is received by a corresponding guiding means in a decreased extent at the bent conformation.

Figure 3a shows side view of a core in an embodiment according to the present invention, wherein the implant is in a straight conformation and the cap is received by the corresponding guiding means in a maximum extent.

Figure 3b shows a perspective view of the core shown in Fig.3a, emphasizing exemplary positioning of openings relative to the core.

Figure 3c shows side view of the core shown in the Fig.3a, wherein the implant is in a bent conformation and the cap is received by the corresponding guiding means in a decreased extent.

Figure 3d shows perspective view of the core shown in Fig.3c, emphasizing that the cap is received by the corresponding guiding means in a decreased extent when the implant is in a bent conformation.

Figure 4a schematizes an exemplary core with a guiding means wherein the cap is received by the guiding means in an increased extent. Figure 4b schematizes the exemplary core shown in Fig.4a, wherein the cap is received by the guiding means in a decreased extent.

Figure 4c schematizes the exemplary core shown in Fig.4a and Fig.4b, wherein the cap is not received by the guiding means, exemplifying the assembly of the core and guiding means before molding of flexible body around those.

Figure 5a exemplifies a penile implant with a flexible body having a partly rugged contour.

Figure 5b shows longitudinal section view of the implant shown in Fig.5a.

Figure 5c exemplifies a penile implant with a flexible body having an essentially smooth contour.

Figure 5d shows longitudinal section view of the implant shown in Fig.5c.

Figure 6 shows a front view of an exemplary core with a guiding means, emphasizing passages thereon.

Figure 7a shows a side view of a core including a sheath.

Figure 7b shows the side view of the core given in Fig.7a, emphasizing helical form of wires.

Figure 8a shows a perspective view of the core given in Fig.7a.

Figure 8b shows a detailed view from the Fig.8a, showing the helix formed by the wires surrounded by the sheath.

Figure 8c shows another perspective view of the core shown in Fig.7a, wherein the occurrence of passage between the wires at an end portion is emphasized.

Detailed Description of the Invention

Referring now the figures outlined before, the present invention proposes a penile implant (100) comprising a core (10) inside a flexible body (20), the core (10) comprising a first end (11) and a second end (12) distal to the first end with respect to a main central axis (Z). The core (10) further comprises an elongate part (19) made of a bendable material. A bendable material can be defined as malleable which essentially keeps its form i.e. conformation in absence of an outer lateral mechanical force with respect to the main central axis (Z). An exemplary side view of such penile implant is depicted in Fig.l. Each of the first end (11) and second end (12) include one or more passage(s) (13) (i.e. through hole) each having two or more openings (14), each passage (13) surrounding a bridge of the material forming the flexible body (20) essentially occupying the space between said openings (14) of respective passage(s) (13). The manufacturing of the penile implant (100) can be achieved by molding of the flexible body (20) around the core (10), and the passages (13) inevitably get filled with the material of the flexible body (20) before completion of the molding process. Each passage (13) as described above assure the position of respective end (11 and/or 12) relative to the flexible body (20), thereby provides reliable conformation changes by manual intervention by the patient using the penile implant (100), whereby free rotation of the ends (11 and/or 12) inside the flexible body (20) during the manual intervention is prevented. This feature is especially meaningful when the penile implant (100) is used in essentially identical pairs mimicking the erectile tissue (corpus cavernosum) of a penis at its erected state, since prevention of free rotation of the ends (11 and/or 12) inside the flexible body (20) during the manual intervention assures that the pair of penile implants are easily brought into essentially identical conformations upon manual intervention i.e. orienting the penis along with the penile implants to a straight or bent conformation/position. The molding can be achieved using e.g. compression molding method.

In malleable penile implant pairs of the prior art, one of the implants had a tendency to move in a direction other than that of its pairing member. This not only causes unrealistic appearance of the penis but also physiological adverse effects on the patient. This problem is solved by the penile implant as proposed by the present invention.

Lists of materials suitable for being used in manufacturing and formation of the elongate part can be easily designated by a person skilled in materials science. Most of the malleable implants have a core made of a silver dominant alloy.

The penile implant (100) according to the present invention can be thus manually brought into different positions by bending it from outside of the penis, or manually bringing it into a straight conformation, in a reliable manner. The penile implant (100) according to the present invention does not require expansion and any related fluid connections in order to function. Therefore it can be obtained from a small number of parts and thus it can have a lean structure resulting in low production costs. Furthermore, due to its lean structure, the penile implant (100) according to the present invention provides a long service life without degradation, which also eliminates the necessity of discomfort due to further frequent surgical operations directed to replacement or maintenance of the implant. Accordingly, the present invention provides a reasonably sufficient comfort to the patient by avoiding or delaying pain/discomfort related to surgical operations and recovery therefrom.

In a possible embodiment of the penile implant (100) according to the present invention, both of the first end (11) and second end (12) form an end portion (15) of the part (19), each end portion (15) corresponding to a length fraction within the range between 5% and 15% with respect to the full length of the part (19). This allows enhanced fixation between the core (10) and the flexible body (20), thereby allowing various design options by still preventing the rotation of the end portions (15) of the core (10) relative to the flexible body (20).

The part (19) (or its core (10)) can be essentially formed from multiple wires (16) made of such bendable material, in which the tips of the wires are hold together by a holding means (17) which is arranged to hold the wires (16) together by limiting their distances relative to each other in a direction perpendicular to the main central axis (Z). With this embodiment, friction between the wires (16) facilitates the conformation maintenance of the penile implant (100) against outer lateral mechanical forces which are not intended by the patient (not initiated with manual intervention), even with decreased use of the bendable material in production of the part (19) or its core (10).

In an embodiment, the wires (16) can be at least partly braid together or interlaced. Alternatively, the wires (16) can essentially form a helix. These embodiments increase friction between adjacent wires (16) and therefore enhance the conformation maintenance of the penile implant (100). In a preferred embodiment, at one or both of the end portions (15), distance (D) between at least two of the wires (16) in a direction perpendicular to the main central axis (Z) is higher than 0.5 mm; this distance is highly sufficient to allow the through flow of the material forming the flexible body (20) before the completion of the molding process. Such embodiment is exemplified in a schematic detailed view shown in Fig.8c. Considering the tips of the wires (16) being held together with the holding means (17), the distances (D) between the wires (17) in a point of such end portions (15) at a perpendicular projection on the main central axis (Z) also serve as passages (13) as described above.

One or both of the end portions (15) can be provided with a cap (18a) arranged to hold the wires (16) together by limiting their distances relative to each other in a direction perpendicular to the main central axis (Z). The cap (18a) can hold and cover the tips of wires (16) at an end portion (15), thereby preventing the tips from reaching out of the flexible body (20) by perforating it. Alternatively, the cap (18a) can be positioned at beginning of the end portion (15) relatively near to the center of gravity of the core (10), thereby limiting and maintaining the above mentioned length fraction by preventing further deviation between adjacent wires (16). When the penile implant (100) is manipulated between its bent and straight conformations (as exemplified in Fig.2c and Fig.2a, respectively), at least a portion of the core (10) is expected to axially move relative to the flexible body (20). This phenomenon may result in wearing out of contact surfaces between the flexible body (20) and a respective first and/or second end (11 and/or 12) of the core (10). To overcome this potential drawback, the penile implant (100) can further comprise a guiding means (18b) adapted to at least partly receive the cap (18a). In this embodiment, the guiding means (18b) and cap (18a) have a cooperating indentation-protrusion couple (not shown) which is adapted to guide axial movements of the cap (18a) relative to the guiding means (18b) along the main central axis (Z) and further adapted to prevent rotational movements of the cap (18a) relative to the guiding means (18b) around the main central axis (Z). The plug-like relative movement between the cap (18a) and guiding means (18b) are schematized in exemplary drawings shown in Fig.2b vs Fig.2d (detail of longitudinal cross-section of a penile implant (100) in its straight and bent states, respectively); Fig.3a and Fig.3b (both showing cores in straight state) vs Fig.3c and Fig.3d (both showing the same cores as in Fig.3a and Fig.3b in a bent state); along with Fig.4a, Fig.4b and Fig.4c (depicting the full relative movement range between the cap and guiding means when the core is considered without being positioned in the flexible body). Thus the zone of the core where a potential maximum extent of relative axial movement between the flexible body and the respective distal end occurs, is covered by the guiding means, thereby further prolonging the service life of the penile implant. In this embodiment, the guiding means can further comprise one or more passage(s) (15) each having two or more openings (14). As described above, the passage (15) surrounds a bridge of the material forming the flexible body (20) essentially occupying the space between said openings (14) of respective passages (15). The passage(s) (15) on the guiding means (18b) can be considered functioning similar or equivalent to the passage(s) (15) in the sense of those described in the main embodiment according to the present invention. Guiding means with passages are exemplified in Fig.3b, and a front detail view showing an exemplary guiding means is given in Fig.6. The penile implant (100) according to the present invention may further comprise a sheath (30) surrounding the core (10) around its main central axis (Z). An exemplary core (10) provided with a sheath (30) is schematized in Fig.7a, in a perspective view shown in Fig.8a, a cross-section thereof shown in Fig.8b, and a detailed view shown in Fig.8c. The sheath (30) compensates any sharp edges in case of fracture or deformation of the core (10) (or of the wires (16)), thereby preventing any rupture due to high pressure points at such sharp edges. Also, the core (10) can be considered guided and channeled inside the sheath (30) thereby axial movements of central portions of the core (10) relative to the flexible body (20) are facilitated without occurrence of wearing out on contact surfaces between the core (10) and the flexible body (20).

In a preferred embodiment, the flexible body (20) can comprise a hydrophilic polymer and the sheath (30) can comprise a hydrophobic outer surface (31). This interrelation lowers the friction on contact surfaces between the core (10) and the flexible body (20) at local axial movements of the core (10) relative to the flexible body (20). In a preferred exemplary embodiment, said hydrophilic polymer comprises silicone polymer, and the sheath (30) comprises an outer surface (31) essentially comprising polytetrafluoroethylene (PTFE); so that the above mentioned friction lowering effect is maximized.

The outer contour of the flexible body (20) can be essentially smooth as exemplified in Fig.5c along with the longitudinal cross-section given in Fig.5d. Alternatively, the outer contour of the flexible body (20) can include a rugged portion (21) as exemplified in Fig.5a along with the longitudinal cross-section given in Fig.5b.

Thus the following objects are achieved by the present invention:

- overcoming the abovementioned shortcomings of the prior art,

- provision of:

o a penile implant, which when implanted as a pair, each cylinder of the pair acts alike to each other when bent or erected by the patient, o a low cost penile implant, and

o a penile implant with an enhanced service life.

List of Reference Numerals

10 core

11 first end of the core

12 second end of the core

13 passage

14 opening

15 end portion

16 wire

17 holding means

18a cap

18b guiding means

19 part

20 flexible body

21 rugged portion 30 sheath

100 penile implant

D distance between adjacent wires at a projection on main central axis

Z main central axis