Patent Description:
Various aspects of the present disclosure are directed toward devices for extending of a penile implant protheses. The device according to the invention includes a support segment, a receiving segment, and at least one extension segment for securing the device at a desired extension distance to the penile implant protheses. The support segment has a tip portion and a threaded portion. The receiving segment is coupled to a distal end of the penile implant. The receiving segment is configured to rotatably receive the threaded portion to secure the support segment to the penile implant. The at least one extension segment is configured to at least partially surround the threaded portion to extend a length between the tip portion and the penile implant. The at least one extension segment may comprise a plurality of extension segments. The plurality of extension segments may include a first extension segment of a first length and a second extension segment of a second length, wherein the first length is different from the second length. The first extension segment may be arranged at the distal end of penile implant and the second extension segment is arranged between the first extension segment and the tip portion. The plurality of extension segments may include three extension segments configured to at least partially surround the threaded portion. The tip portion may include a rounded shape contoured according to the distal end of the penile implant. The support segment may comprise a biopolymer material. The at least one extension segment may comprise a biopolymer material. The at least one extension segment may be substantially cylindrical.

Various aspects of the present disclosure, not forming a part of the invention, are also directed toward devices, systems, and methods that may include an extension device including a bellows segment and a bevels segment. The bellows segment may have a hollow body portion and a rounded tip portion. The body portion may include a circumferential wall having a plurality of internal grooves and at least one aperture adjacent and perpendicular to the internal grooves. The bevels segment may have at least one protrusion configured to spirally rotate to engage with the plurality of internal grooves of the bellows segment and lock into place within the at least one aperture. The at least one aperture may include a pair of apertures disposed <NUM> degrees apart, the pair of apertures adjacent and perpendicular to the internal grooves. The circumferential wall may include at least two pairs of apertures offset longitudinally and configured to facilitate different desired extension distances. The rounded tip portion may include a shape contoured according to the distal end of the penile implant. The bellows segment may comprise a biopolymer material. The bevels segment may comprise a biopolymer material.

Various aspects of the present disclosure, not forming a part of the invention, are also directed toward devices, systems, and methods that may include an extension device including a support segment having a tip portion, a threaded portion, and an expandable bellows segment. The expandable bellows segment is arranged between the tip portion and the threaded portion. The tip portion includes a port configured to receive a fluid for expanding the expandable bellows segment. The threaded portion is configured to mate with a receiving segment coupled to a distal end of the penile implant. The receiving segment may be configured to rotatably receive the threaded portion to secure the support segment to the penile implant. The expandable bellows segment may be configured to facilitate desired extension distances. The tip portion may include a rounded shape contoured according to the distal end of the penile implant. The support segment may comprise a biopolymer material. The support segment may be of one-piece construction.

Prior art document <CIT> discloses an implantable penile prosthesis having an adjustable length rear tip extender. The extender is connectable with at least one inflatable cylinder. The adjustable length rear tip extender can be telescoping, or include one or more segments capable of being cut away or otherwise removed, to adjust the effective length for the at least one inflatable cylinder.

Prior art document <CIT> discloses an inflatable penile prosthetic system including a pump adapted for attachment to a reservoir; a penile prosthetic assembly including an inflatable bladder having a distal end sized for placement within a glans penis, a base connected to the inflatable bladder, with base including an interior channel extending an entire length of the base from a hole formed in a proximal end of the base to the inflatable bladder, and a tubing port coupled to an exterior surface of the base, with the tubing port adapted for attachment to the pump, a plug sized for insertion into the hole; and a push rod. The plug providing a combination seal and rear tip extender adapted to increase the length of the penile prosthetic.

While the invention is amenable to various modifications and alternative forms, specific aspects have been shown by way of example in the drawings and are described in detail below.

Various aspects of the present disclosure are directed toward implantable medical devices for the treatment of male erectile dysfunction. Surgical implantation of prostheses may include penile implants. In certain implant procedures, the implant includes an extension device in order to appropriately size the device to the patient. The extension devices, consistent with various aspects of the present disclosure, may be capable of extending an implant for erectile dysfunction to the desired extension distance.

<FIG> illustrates an extension device <NUM>, according to some embodiments. Device <NUM> is an adjustable rear tip extender device. As shown in <FIG>, the device <NUM> includes a support segment <NUM>, a plurality of extension segments <NUM>, and a receiving segment <NUM> insertable within the distal end <NUM> of penile implant <NUM>. Receiving segment <NUM> of device <NUM> may be a screw in feature for attachment of device <NUM> to the distal end <NUM> of a penile implant <NUM>. The extension segments <NUM> may include an open central bore or area as shown.

As shown in <FIG>, support segment <NUM> has a tip portion <NUM>, an end portion <NUM> (shown in <FIG>), and a threaded portion <NUM> between the tip portion <NUM> and the end portion <NUM>. Tip portion <NUM> includes a rounded shape contoured according to the distal end <NUM> of the penile implant <NUM> so that the penile implant <NUM> and device <NUM> combination has a smooth external surface. The smooth external surface of the tip portion <NUM> allows device <NUM> to seamlessly take the place of the end (not shown) of the penile implant <NUM>. The smooth design of tip portion <NUM> allows for easier insertion. Tip portion <NUM> is solid and thus the pivot point will not be altered by the addition of device <NUM> to penile implant <NUM>, therefore, the stability of the penile implant <NUM> is uncompromised. As shown in <FIG>, end portion <NUM> may be blunt, in other words, a smooth surface free of sharp corners or edges. Advantages of the smooth surface of the end portion <NUM> include ensuring injury-free insertion by the surgeon while also ensuring that the penile implant <NUM> will not be damaged during insertion.

The device <NUM> is adjustable to a desired extension distance D<NUM> according to the number and/or width of the extension segments <NUM> loaded onto the support segment <NUM>. In other words, one, two, three, or more extension segments <NUM> may at least partially surround or encircle the support segment <NUM> in order to achieve a desired extension distance D<NUM>. As shown in <FIG>, each extension segment <NUM> may have a different length, e.g., segment <NUM> having a first length L<NUM>, segment <NUM> having a second length L<NUM>, segment <NUM> having a third length L<NUM>. Therefore, the extension distance D<NUM> is adjustable according to whether the segment <NUM> and/or segment <NUM> and/or segment <NUM> is loaded onto the support segment <NUM>. The device <NUM> may be used, for example, to provide a prosthesis having a desired length that is appropriate to the patient. In certain instances, additional hollow extension segments <NUM> than the ones shown may be included to further adjust the length as desired.

In some embodiments, the support segment <NUM> having tip portion <NUM> a tip length, Lt, contributes also to the extension distance D<NUM>. In a non-limiting example, length Lt contributes <NUM> to the extension distance D<NUM>. Each segment adds as needed, e.g., in a non-limiting example, segment <NUM> having length L<NUM> of <NUM>, segment <NUM> having length L<NUM> of <NUM>, and segment <NUM> having length L<NUM> of <NUM>. Segments <NUM>, <NUM>, and <NUM> are added so that the extension distance D<NUM> ranges from about <NUM> including length Lt only to about <NUM> with the three segments <NUM>, <NUM>, and <NUM> added. In some embodiments, any number of extension segments <NUM> (e.g., <NUM>, <NUM>, <NUM>) are used as desired. In various embodiments, extension segments <NUM> may each be of the same width or of different widths as in the non-limiting example above.

As shown in <FIG>, receiving segment <NUM> is disposed at the distal end <NUM> of the penile implant <NUM>. Receiving segment <NUM> is coupled to the support segment <NUM> by rotating the support segment <NUM> into the receiving segment <NUM> to secure the device at a desired extension distance D<NUM>. Threaded portion <NUM> includes a plurality of threads <NUM>. Receiving segment <NUM> includes a hole <NUM>, and the hole <NUM> including a plurality of internal grooves <NUM>. Internal grooves <NUM> (shown in <FIG>) are configured to matingly receive the plurality of the threads <NUM> (shown in <FIG>) to secure the support segment <NUM> at the desired extension distance D<NUM>.

Device <NUM> is attached to a penile implant <NUM> at the distal end <NUM> via receiving segment <NUM>. Device <NUM> works by being screwed into the back of the penile implant <NUM>. Moreover, device <NUM> includes the non-hollow support segment <NUM> to provide greater strength along the extension distance D<NUM>. Device <NUM> may be advantageously safer and more stable than other RTE designs, which were hollow and prone to failure by snapping off due to the pivot point moving anteriorly toward the head of the penis.

Support segment <NUM> and/or extension segments <NUM> and/or receiving segment <NUM> of the device <NUM> may include any suitable medical grade material. Examples of such materials include various biopolymer, and/or other various biologically compatible materials. In preferred instances, the biopolymer material is hydrophilic. In certain instances, the support segment <NUM> may be Bioflex®. In certain instances, the extension segments <NUM> may be a Bioflex®. In certain instances, the receiving segment <NUM> may be a Bioflex. <FIG> illustrates an extension device <NUM>, according to other examples, not forming a part of the invention. Device <NUM> may include a click lock rear tip extender device for extending a penile implant. The device <NUM> includes a bellows segment <NUM> and a bevels segment <NUM>. As illustrated in the cross-sectional view of bellow segment <NUM> in <FIG>, bellows segment <NUM> has a hollow body portion <NUM> and a rounded tip portion <NUM>. In some embodiments, the rounded tip portion <NUM> includes a shape contoured according to the distal end of the penile implant. In some embodiments, the tip portion <NUM> may be solid.

As shown in <FIG>, the hollow body portion <NUM> includes a circumferential wall <NUM> having a plurality of internal grooves <NUM>. The circumferential wall <NUM> further includes at least one aperture <NUM> through the circumferential wall <NUM>. The at least one aperture <NUM> is adjacent and perpendicular to an internal groove <NUM>. In some embodiments, the at least one aperture <NUM> may include a shape, such as a circular or rectangular shape. In some embodiments, the circumferential wall <NUM> includes a pair of apertures <NUM> disposed <NUM> degrees apart (as shown in <FIG>). Each of the apertures <NUM> in the pair of apertures <NUM> is adjacent and perpendicular to an internal groove <NUM>. In yet other embodiments, the circumferential wall <NUM> includes at least two pairs of apertures <NUM> with each pair of apertures <NUM> offset longitudinally and configured to facilitate different desired extension distances D<NUM>. As shown in <FIG>, each aperture <NUM> is offset longitudinally. In various embodiments, circumferential wall <NUM> may include three pairs of apertures <NUM>, or four pairs of apertures <NUM>, or more, with each pair of apertures <NUM> offset longitudinally to allow adjusting the device <NUM> to a desired extension distances D<NUM>.

As shown in <FIG>, bevels segment <NUM> includes a plurality of external bevels <NUM> in a first portion <NUM> for mating with a distal end of a penile implant (not shown). The bevels segment <NUM> includes at least one protrusion <NUM> in a second portion <NUM>. The at least one protrusion <NUM> is spirally rotatable to engage with the plurality of internal grooves <NUM> of the bellows segment <NUM> and lock into place within the at least one aperture <NUM>. The at least one protrusion <NUM> may be clicked or locked into place to the at least one aperture <NUM> when aligned at a desired extension distance D<NUM>. In some embodiments, the at least one protrusion <NUM> may include a shape, such as a circular or rectangular shape, to matingly engage with the at least one aperture <NUM>. In some embodiments, portion <NUM> includes a pair of protrusions <NUM>, which may be clicked or locked into place to a pair of apertures <NUM> when aligned at a desired extension distance D<NUM>.

In certain instances, the aperture(s) <NUM> may have dimensions different from the protrusion(s) <NUM> to facilitate a snap fit. In certain instances, the protrusion(s) <NUM> of bevels segment <NUM> are disengaged from the bellow segment <NUM> to adjust the distance D<NUM> and then reengaged by mating the protrusion(s) <NUM> to another longitudinally offset aperture <NUM> or pair of apertures <NUM>.

Bellows segment <NUM> and/or bevels segment <NUM> of the device <NUM> may include any suitable medical grade material. Examples of such materials include various biopolymer, and/or other various biologically compatible materials. In certain instances, the bellows segment <NUM> may be Bioflex®. In certain instances, the bevels segment <NUM> may be a Bioflex®.

<FIG> illustrates an extension device <NUM>, according to some examples, not forming a part of the invention. Device <NUM> is another adjustable rear tip extender device. As shown in <FIG>, the device <NUM> includes a support segment <NUM> having a tip portion <NUM>, a threaded portion <NUM>, and an expandable bellows segment <NUM>. Expandable bellows segment <NUM> is arranged between the tip portion <NUM> and the threaded portion <NUM>. Expandable bellows segment <NUM> is hollow. Threaded portion <NUM> includes a plurality of threads <NUM>.

As shown in <FIG>, the tip portion <NUM> further includes a port <NUM> configured to receive a fluid F. Fluid F may include biomedically compatible fluids such as. Fluid F is injected into port <NUM> via a delivery apparatus <NUM>, which may be a syringe. As fluid F is injected or otherwise delivered into port <NUM>, fluid F passes through tip <NUM> and is received by the expandable bellows segment <NUM>. As fluid F is filled into the expandable bellows segment <NUM>, into the expandable bellows segment <NUM> is elongated to expand longitudinally to a desired distance. Advantageously, device <NUM> is expandable to any desired distance from an initial unexpanded configuration Di, having no fluid F in expandable bellows segment <NUM>, to a final fully expanding configuration Df, having expandable bellows segment <NUM> fully loaded with fluid F to maximum capacity. <FIG> shows expandable bellows segment <NUM> in an expanded configuration providing a desired distance D<NUM>. Support segment <NUM> of <FIG> is shown in <FIG> in an unfilled, unexpanded configuration providing a distance D<NUM>, wherein distance D<NUM> is less than distance D<NUM>. Because device <NUM> may provide any desired distance between an initial (unexpanded) distance Di a final (fully expanded) distance Df, advantageously the desired distance may be tailored to the patient without requiring additional components.

Receiving segment (not shown) of device <NUM> may be a screw in feature for attachment of device <NUM> to the distal end <NUM> of a penile implant <NUM> (similarly as shown in <FIG> for device <NUM> having receiving segment <NUM>). For example, receiving segment <NUM> may be coupled to a distal end of the penile implant. The receiving segment is configured to rotatably receive the threaded portion <NUM> having plurality of threads <NUM> to secure the support segment <NUM> to the penile implant <NUM>.

Support segment <NUM> may be of one-piece construction. Support segment <NUM> or any portion thereof, including tip portion <NUM>, threaded portion <NUM>, and expandable bellows segment <NUM>, of the device <NUM> may include any suitable medical grade material. Examples of such materials include various biopolymer, and/or other various biologically compatible materials. In preferred instances, the biopolymer material is hydrophilic. In certain instances, the support segment <NUM> may be Bioflex®. In certain instances, the tip portion <NUM> may be a Bioflex®. In certain instances, the threaded portion <NUM> may be a Bioflex. In certain instances, the expandable bellows segment <NUM> may be a Bioflex. In some embodiments, the rounded tip portion <NUM> includes a shape contoured according to the distal end of the penile implant. In some embodiments, the tip portion <NUM> may be solid and substantially encircling port <NUM>.

Claim 1:
An extension device (<NUM>) for extending a penile implant (<NUM>), the device comprising:
a support segment (<NUM>) having a tip portion (<NUM>) and a threaded portion (<NUM>);
a receiving segment (<NUM>) insertable into a distal end (<NUM>) of the penile implant (<NUM>), the receiving segment (<NUM>) configured to rotatably receive the threaded portion (<NUM>) to secure the support segment (<NUM>) to the penile implant (<NUM>); and
at least one extension segment (<NUM>) configured to at least partially surround the threaded portion (<NUM>) to extend a length between the tip portion (<NUM>) and the penile implant (<NUM>).