Patent Description:
One treatment for male erectile dysfunction is the implantation of a penile prosthesis that may be placed in multiple configurations. For example, some existing penile prostheses may be implanted in or near the penis of the patient and may be disposed in a first configuration to place the penis in a flaccid-like state and may be disposed in a second configuration to place the penis in an erect-like state. Some existing implants include complex activation mechanisms to change the configurations of the implants and may require a large amount of effort to change or convert the implant from one configuration to another configuration.

It would be useful to provide a bodily implant, such as a penile prosthesis that may efficiently be moved from one configuration to another configuration.

<CIT> discloses a penile prosthesis designed to be surgically implanted in the penis for the treatment of erectile impotence, comprising an articulated column having alternating joints enclosed with a switch within an outer elongated sheath. The switch is aligned for reversibly extending the articulated column against the ends of the sheath and tensioning a tension member whereby frictional resistance at the joints increases causing an erect state.

Similar prostheses are disclosed in <CIT>, which claim priority from <CIT>, <CIT>, and <CIT>.

A mechanical penile prosthesis is disclosed in <CIT>, which includes a sleeve, encapsulating a linear assembly of cups which allow the prosthesis to be bent from an erect position to a flaccid position.

<CIT> discloses a penile implant comprising a volume of liquid which is expandable to arrange the implant between an elongated rigid state and a flexible, flaccid state.

The invention is concerned with a penile implant as defined in the claims.

These and other aspects, embodiments and advantages of the present disclosure will become immediately apparent to those of ordinary skill in the art upon review of the detailed description, also having regard to the figures and the claims.

Details of the present disclosure are disclosed herein. However, it is understood that the disclosure refers to examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

The terms "a" or "an", as used herein, are defined as one or more than one. The term "another", as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open transition). The term "coupled" or "moveably coupled", as used herein, is defined as connected, although not necessarily directly and mechanically.

In general, the disclosure is directed to medical devices such as penile prostheses or other bodily implants. The term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure. For example, in some embodiments, the patient may be a human male, a human female, or any other mammal.

The terms proximal and distal described in relation to various devices, apparatuses, and components as discussed in the subsequent text of the present disclosure are referred with a point of reference. The point of reference, as used in this description, is a perspective of a person who implants the device such as the penile prosthesis. The person may be a surgeon, a physician, a nurse, a doctor, a technician, and the like who may perform the implantation procedure. The term proximal refers to an area or portion that is closer or closest to the person during the implantation procedure. The term distal refers to an area or portion that is farther or farthest from the person.

The disclosure discussed herein may improve the performance of a penile prosthesis. For example, the penile prosthesis may have improved usability. Specifically, the penile prosthesis may require a small amount of effort to convert the implant from a first configuration to a second configuration. Additionally, the penile prosthesis may require less effort to implant the device into the body of a patient.

<FIG> schematically illustrates an implant <NUM> according to the present disclosure. The implant <NUM> includes a sheath or sheath member <NUM>, a cable or cable member <NUM>, and a tensioner <NUM>. The implant <NUM> may be disposed or placed within a body of a patient or user. The implant <NUM> is a penile implant and the implant <NUM> may be placed within a penis of a patient. Specifically, the implant <NUM> may be implanted within the corpus cavemosum of the patient. The implant may also be placed in other locations within the body of the patient.

More than one implant <NUM> may be placed within the body of the patient. For example, two implants <NUM> may be placed within the body of the patient. Specifically, two implants <NUM> may be placed within a penis of the patient. The implants may be placed within the penis of the patient in substantially parallel or side-by-side arraignment. Alternatively only one implant <NUM> is disposed or implanted within the body of the patient.

As will be described in more detail below, the implant <NUM> may be placed in a first configuration and a second configuration different than the first configuration. For example, the implant <NUM> may be able to be placed in a straight or linear configuration and in a curved or non-linear configuration. Accordingly, the implant <NUM> may be placed within a penis of the patient and the patient may selectively place the implant in (<NUM>) a straight or linear configuration to achieve or simulate an erect penis or (<NUM>) a curved or non-linear configuration to achieve or simulate a flaccid penis.

The sheath or sheath member <NUM> is an elongate member and is configured to be placed in a first configuration and second configuration different than the first configuration. For example, the sheath <NUM> may be able to be placed in a straight or linear configuration and in a curved or non-linear configuration. The sheath <NUM> or a sidewall of the sheath <NUM> defines or includes a slot or an opening or a plurality of slots or openings. The sheath <NUM> can include or define a pattern of slots or openings. The slots or openings may be configured to allow or facilitate the placement of the sheath <NUM> in the different configurations. The sheath <NUM> may define slots or openings along only a portion of the length of the sheath.

The sheath <NUM> defines a lumen. The lumen may extend from one end portion of the sheath <NUM> to an opposite end portion of the sheath <NUM>. The lumen may house or receive other components of the implant <NUM>.

The cable or cable member <NUM> is coupled to sheath <NUM> and is configured to selectively apply tension to the sheath <NUM>. The cable or cable member <NUM> may apply tension to the sheath <NUM> to place the sheath in its first, straight, or linear configuration. As discussed in more detail below, the tension may be removed from the sheath <NUM> to place the sheath in its second, curved, or non-linear configuration.

The cable <NUM> can be coupled to the sheath <NUM> at a first end portion of the sheath and at a second end portion of the sheath <NUM>, or the cable <NUM> can be coupled to other portions of the sheath <NUM>. For example, the cable <NUM> can be coupled to the sheath <NUM> at other locations along the length of the sheath <NUM>.

The cable <NUM> can be of a fixed length and may be non-extendable. In other words, the cable <NUM> is configured such that it does not stretch or has very little capacity to stretch or lengthen. Accordingly, the cable <NUM> is also able to apply tension to the sheath <NUM>. The cable <NUM> is preferably formed of or from a material that has little capacity to stretch.

The tensioner <NUM> is operatively coupled to the sheath <NUM> and to the cable <NUM>. The tensioner <NUM> is configured to engage the cable <NUM> such that tension may be selectively applied to the sheath <NUM>. The tensioner <NUM> includes a release member. The release member can be configured to help retain tension on sheath <NUM> and may be actuated to selectively release the tension applied to the sheath <NUM>.

<FIG> illustrate an implant <NUM> according to an aspect. <FIG> is a perspective view of the implant <NUM>. <FIG> is a cross-sectional view of the implant <NUM>. <FIG> is an exploded view of the implant <NUM>. <FIG> is a cross-sectional view of a portion of the implant <NUM> while the implant <NUM> is in a first configuration. <FIG> is a cross-sectional view of a portion of the implant <NUM> while the implant <NUM> is in a second configuration. <FIG> is a side view of a sheath <NUM> of the implant <NUM>. <FIG> schematically illustrates the implant <NUM> disposed within a body of a patient.

The implant <NUM> includes a sheath or sheath member <NUM>, a cable or cable member <NUM>, and a tensioner <NUM>. The implant <NUM> may be disposed or placed within a body of a patient or user. For example, the implant <NUM> is a penile implant and the implant <NUM> may be placed within a penis of a patient. Specifically, the implant <NUM> may be implanted within the corpus cavemosum of the patient. The implant <NUM> may also be placed in other locations within the body of the patient.

More than one implant <NUM> may be placed within the body of the patient. For example, two implants <NUM> may be placed within the body of the patient. Specifically, two implants <NUM> may be placed within a penis of the patient. The implants may be placed within the penis of the patient in a substantially parallel or a side-by-side arraignment. Alternatively only one implant <NUM> is disposed or implanted within the body of the patient.

As will be described in more detail below, the implant <NUM> may be placed in a first configuration and a second configuration different than the first configuration. For example, the implant <NUM> may be able to be placed in a straight or linear configuration and in a curved or non-linear configuration. Accordingly, the implant <NUM> may be placed within a penis of the patient and the patient may selectively place the implant <NUM> in (<NUM>) a straight or linear configuration to achieve or simulate an erect penis or (<NUM>) a curved or non-linear configuration to achieve or simulate a flaccid penis.

The sheath or sheath member <NUM> is an elongate member and is configured to be placed in a first configuration and second configuration different than the first configuration. For example, the sheath <NUM> may be able to be placed in a straight or linear configuration and in a curved or non-linear configuration.

The sheath <NUM> includes a sidewall <NUM>. As best illustrated in <FIG>, the sidewall <NUM> of the sheath <NUM> defines or includes a series or a plurality of slots or openings <NUM>. The slots or openings <NUM> extend through the sidewall <NUM>. Specifically, the sidewall <NUM> of the sheath <NUM> may include or define a pattern of slots or openings. The slots or openings <NUM> allow or facilitate the placement of the sheath <NUM> in the different configurations. Specifically, the slots or openings <NUM> allow the sheath <NUM> to be flexible at the locations of the slots or openings <NUM>. Accordingly, the sheath <NUM> may bend or flex at the location of the slots or openings. The slots or openings <NUM> may be non-linear or linear. The adjacent portions of the sidewall <NUM> that define the slots or openings <NUM> are configured to engage each other and lock into place. Such engagement may increase the columnar strength of the sheath <NUM> when the sheath is in its straight or linear configuration.

The sidewall <NUM> of the sheath <NUM> can define slots or openings along a middle portion <NUM> of the sheath <NUM>. The sidewall <NUM> can be solid (or does not define slots or openings) at the end portions <NUM> and <NUM> of the sheath. Alternatively the openings or slots may be present along more or less of the sheath.

The sheath <NUM> defines a lumen <NUM>. The lumen <NUM> extends from the first end portion <NUM> of the sheath <NUM> to the second end portion <NUM> of the sheath <NUM>. As discussed below, the lumen <NUM> is configured to house or receive other components of the implant <NUM>. Alternatively, in an example that is not claimed, the sheath <NUM> does not include or define a lumen.

The sheath <NUM> may be formed of any biocompatible material. The sheath <NUM> can be formed of a rigid material, for example, the sheath <NUM> can be formed of a polymer material, or a metal material.

The cable <NUM> is disposed within the lumen <NUM> defined by the sheath <NUM>. The cable <NUM> is coupled to the sheath <NUM> at the first end portion <NUM> of the sheath <NUM> and at the second end portion <NUM> of the sheath <NUM>. Specifically, the cable <NUM> can be coupled to the first end portion <NUM> of the sheath <NUM> via a crimp member <NUM>. The cable <NUM> can be coupled to the second end portion <NUM> if the sheath <NUM> via a crimp member <NUM>.

The device may include a centering member <NUM>. The centering member <NUM> may be configured to be disposed between the cable <NUM> and the sheath <NUM>. The centering member <NUM> is configured to help retain the cable <NUM> in or along the center of the sheath <NUM>. For example, the centering member <NUM> can be an elongate member that defines a lumen, whereby the cable <NUM> is disposed within the lumen of the centering member <NUM>.

The cable <NUM> can be coupled to other portions of the sheath <NUM>. For example, the cable <NUM> can be coupled to the sheath <NUM> at other locations along the length of the sheath <NUM>.

The cable <NUM> is of a fixed length and is non-extendable. In other words, the cable <NUM> is configured such that does not stretch or has very little capacity to stretch or lengthen. Accordingly, the cable <NUM> is able to apply tension to the sheath <NUM>. The cable <NUM> can be formed of or from a material that has little capacity to stretch.

The tensioner <NUM> is operatively coupled to the sheath <NUM> and to the cable <NUM>. The tensioner <NUM> is configured to engage the cable <NUM> such that tension may be selectively applied to the sheath <NUM>.

The tensioner <NUM> preferably includes a plunger member <NUM>, a bias member <NUM>, a plunger guide <NUM>, a first release member <NUM>, and a second release member <NUM>. The plunger member <NUM>, the bias member <NUM>, and the plunger guide <NUM> may be disposed within the lumen <NUM> defined by the sheath <NUM>. Additionally, the cable <NUM> may extend through the plunger member <NUM>, the bias member <NUM>, and the plunger guide <NUM>.

The bias member <NUM> is configured to provide a bias to the tensioner <NUM>. Specifically, the bias member <NUM> is configured to provide a bias to the tensioner <NUM> such that the tension is removed from the sheath <NUM>. Accordingly, the sheath <NUM> is biased to its curved or non-linear configuration. The bias member <NUM> is preferably a spring member. The cable <NUM> can be configured to move or slide within the sheath <NUM> when moved from the tensioned position and the non-tensioned position. In some embodiments, the amount of movement is about <NUM>. In other embodiments, the cable <NUM> is configured to slide or move more with respect to the sheath <NUM>.

Release members <NUM> and <NUM> may be structurally and functionally similar. Accordingly, only release member <NUM> will be discussed in detail.

The release member <NUM> is configured to help retain tension on sheath <NUM> and may be actuated to selectively release the tension applied to the sheath <NUM>. The release member <NUM> is moveable with respect to the sheath <NUM>. The release member <NUM> can be pivotably movable with respect to the sheath <NUM>. For example, the release member <NUM> may be pivotably coupled to the sheath <NUM> or may be pivotally coupled to the plunger guide <NUM> or to another portion of the tensioner <NUM>.

The release member <NUM> includes an engagement portion <NUM>. As best illustrated in <FIG>, the engagement portion <NUM> is configured to contact a portion of the plunger member <NUM> to help retain the sheath <NUM> in its first, straight, or linear configuration. The release member <NUM> also includes an activation portion <NUM>. The activation portion <NUM> may be used or moved with respect to the sheath <NUM> to pivot or rotate the release member <NUM>. Movement or rotation of the release member <NUM> causes the engagement portion <NUM> to disengage the plunger member <NUM>. The plunger member <NUM> will then be moved by the bias member <NUM> and the sheath <NUM> will assume its second, curved, or non-linear configuration.

The sheath <NUM> can define a window or opening <NUM>. A portion of the release member <NUM> can extends from the window or opening <NUM>. Note that the release member <NUM> extends from another window or opening <NUM> defined by the sheath <NUM>. Accordingly, a user may access the release member <NUM> to activate or apply pressure to the activation portion <NUM> of the release member <NUM>. For example, when the implant <NUM> is disposed within a body of the patient, the user may contact or active the release member <NUM> by pressing on skin or bodily tissue. The release member <NUM> is accessible by a user through the window or opening <NUM>. Alternatively, the release member <NUM> does not extend through the window or opening <NUM>.

The implant can also include an end cap <NUM> coupled to the first end portion <NUM> of the sheath <NUM>. Similarly, the implant <NUM> can also include a front tip base <NUM> and a front tip <NUM> coupled to the second end portion <NUM> of the sheath <NUM>.

The implant <NUM> may include a sleeve or cover that is configured to extend about an outside surface of the sheath <NUM>. In some embodiments, the sleeve or cover may cover the entire outer surface of the sheath <NUM>. In other embodiments, the sleeve or cover may cover only a portion of the outer surface of the sheath <NUM>. In some embodiments, the sleeve or cover may be formed or a bioabsorbable material.

As illustrated in <FIG>, the implant may be placed or disposed within a penis P of a patient or user. A first implant 200A and a second implant 200B can be disposed or placed within the penis of the patient. The implants are placed in a parallel or side-by-side relationship (with the urethra of the patient extending between the implants), alternatively only one implant may be disposed within the patient. Additionally, the implant can be placed or disposed in another portion of the body of the patient.

In use, a user or patient may straighten their penis to place the implant <NUM> in its first, straight, or linear configuration. For example, a user may grasp and lift an end of their penis to straighten their penis and place the implant <NUM> in its first, straight, or linear configuration (for example, as illustrated in <FIG>). The lifting of the end portion or straightening of the implant <NUM> will cause the plunger member <NUM> to move towards the first end portion <NUM> of the sheath <NUM> (against the bias of the bias member <NUM>). The release members <NUM> and <NUM> will engage the plunger member <NUM> to retain the plunger member <NUM> in place. This movement will apply tension to the sheath <NUM> via the cable <NUM>. In this configuration, the sheath <NUM> is retained in its first, straight, or linear configuration.

A user or patient may activate or press on the release members <NUM> and <NUM> to release the tension applied to the sheath <NUM> and allow the sheath to assume its second, curved, or non-linear configuration. As best illustrated in <FIG>, when the release members <NUM> and <NUM> are moved or activated by a user, the retention member is moved out of engagement with the plunger <NUM> and the bias member <NUM> moves the plunger towards the second end portion <NUM> of the sheath <NUM>. This movement removes the tension on the sheath <NUM> and allows the sheath to assume its second, curved, or non-linear configuration.

Claim 1:
A penile implant (<NUM>, <NUM>), comprising:
a sheath (<NUM>, <NUM>) defining a lumen (<NUM>);
which sheath (<NUM>, <NUM>) further defines a window or opening (<NUM>, <NUM>) in the sheath (<NUM>,<NUM>);
a cable member (<NUM>, <NUM>) disposed within the lumen of the sheath (<NUM>, <NUM>); and
a tensioner (<NUM>, <NUM>) engaged with the cable member (<NUM>, <NUM>) configured to apply tension to the sheath (<NUM>, <NUM>) so that the sheath (<NUM>, <NUM>) is selectively arrangeable between a first tensioned configuration and second non-tensioned configuration,
wherein the tensioner (<NUM>, <NUM>) comprises a bias member (<NUM>), configured to provide a bias to the tensioner (<NUM>, <NUM>),
wherein the tensioner (<NUM>, <NUM>) comprises a release member (<NUM>, <NUM>), the release member (<NUM>, <NUM>) being moveable between a tension retention position, wherein tension is retained in the sheath (<NUM>, <NUM>), and a tension release position, wherein tension is released from the sheath (<NUM>, <NUM>),
wherein the release member (<NUM>, <NUM>) is accessible and operable through the window or opening (<NUM>, <NUM>) in the sheath (<NUM>, <NUM>), whereby a portion of the release member (<NUM>, <NUM>) is extendible through the window or opening (<NUM>,<NUM>) in the sheath (<NUM>, <NUM>),
wherein the sheath (<NUM>, <NUM>) includes a sidewall (<NUM>) defining or including a series or a plurality of slots or openings (<NUM>), wherein the slots or openings (<NUM>) are configured to allow the sheath (<NUM>, <NUM>) to be flexible at the locations of the slots or openings (<NUM>) and wherein the adjacent portions of the sidewall (<NUM>) that define the slots or openings (<NUM>) are configured to engage each other and lock into place.