U.S. patent application number 17/220548 was filed with the patent office on 2021-07-22 for implants that facilitate tissue expansion.
This patent application is currently assigned to AUGMENTA, LLC. The applicant listed for this patent is AUGMENTA, LLC. Invention is credited to Robert J. Cornell, Hans Mische, David Nichols.
Application Number | 20210220140 17/220548 |
Document ID | / |
Family ID | 1000005493334 |
Filed Date | 2021-07-22 |
United States Patent
Application |
20210220140 |
Kind Code |
A1 |
Cornell; Robert J. ; et
al. |
July 22, 2021 |
IMPLANTS THAT FACILITATE TISSUE EXPANSION
Abstract
The invention pertains to implants that facilitate tissue
expansion while not substantially inhibiting normal anatomical
movement. The implants may be made of different materials or made
in different configurations such that such that a measured property
at a first location on said implant is different than said same
measured property at a second location on said implant. In one
particular embodiment the implants may be a cosmetic penile
implant.
Inventors: |
Cornell; Robert J.;
(Houston, TX) ; Nichols; David; (Bullard, TX)
; Mische; Hans; (Grey Eagle, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AUGMENTA, LLC |
Houston |
TX |
US |
|
|
Assignee: |
AUGMENTA, LLC
Houston
TX
|
Family ID: |
1000005493334 |
Appl. No.: |
17/220548 |
Filed: |
April 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16238821 |
Jan 3, 2019 |
10980639 |
|
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17220548 |
|
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62702062 |
Jul 23, 2018 |
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62779825 |
Dec 14, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2250/0078 20130101;
A61F 2/26 20130101; A61F 2250/0018 20130101; A61F 2250/0019
20130101; A61F 2250/0025 20130101; A61F 2220/0008 20130101; A61F
2250/0037 20130101; A61F 2250/0053 20130101; A61F 2250/0071
20130101 |
International
Class: |
A61F 2/26 20060101
A61F002/26 |
Claims
1. An implant suitable for a desired animal or human body part or
portion thereof wherein the implant comprises an implant body
comprising one or more biocompatible materials wherein said one or
more materials are selected or configured to facilitate tissue
expansion while not substantially inhibiting normal anatomical
movement and wherein said one or more biocompatible materials
comprise internal pockets of inaccessible enclosed void spaces
within the implant body configured such that a measured property at
a first location on said implant is different than said same
measured property at a second location on said implant and wherein
said measured property comprises one or more of the following
properties: (1) hardness; (2) tensile strength; (3) tear strength;
(4) compressive strength; and (5) elongation.
2. The implant of claim 1 wherein at least one additional measured
property at a first location on said implant is different than said
same measured property at a second location on said implant.
3. The implant of claim 2 wherein said additional measured property
comprises one or more of the following properties: (1) hardness;
(2) tensile strength; (3) tear strength; (4) compressive strength;
and (5) elongation.
4. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having both linear and radial
compression capability.
5. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having a durometer range of from about
0 to about 70 durometer on the Shore A scale.
6. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having a tensile strength of from
about 200 psi to about 800 psi.
7. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having an elongation of from about
600% to about 1200%.
8. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having a tear strength of from about
40 pounds per inch (ppi) to about 130 ppi.
9. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having a compressibility and
extensibility factor of up to about 25%.
10. The implant of claim 1 wherein said implant comprises one or
more biocompatible materials having two or more of the following:
(1) a durometer range of from about 0 to about 70 durometer; (2) a
tensile strength of from about 200 psi to about 800 psi; an
elongation of from about 600% to about 1200%; (3) a tear strength
of from about 40 ppi to about 130 ppi; and (4) a compressibility
and extensibility factor of up to about 25%.
11. The implant of claim 1 wherein said implant further comprises a
hydrophilic agent.
12. The implant of claim 1 wherein said implant comprises a wall
having a varying wall thickness.
13. The implant of claim 1 wherein said one or more materials are
configured to comprise one or more internal pockets that vary in
one or more of the following: geometry, size, depth, or
location.
14. The implant of claim 13 wherein the said one or more internal
pockets are configured to result in one or more of the following:
(1) reduce rigidity of at least a portion of the implant, (2)
reduce the total weight of the implant, (3) increase elasticity of
at least a portion of the implant, (4) increase extensibility of at
least a portion of the implant, or (5) increase compressibility of
at least a portion of the implant.
15. The implant of claim 13 wherein said one or more internal
pockets comprise those selected from compression pockets,
elongation pockets, or both.
16. The implant of claim 15 wherein said internal pockets permit
stretching of up to 500% compared to the same implant substrate
without internal pockets.
17. The implant of claim 1 wherein said internal pockets comprise a
honeycomb design.
18. The implant of claim 1 wherein said biocompatible material
comprises a material that releases heat.
19. The implant of claim 1 wherein said biocompatible material
comprises a material that absorbs heat.
20. The implant of claim 1 wherein said configuration comprises
internal pockets and wherein one or more biocompatible materials
have two or more of the following: (1) a durometer range of from
about 10 to about 70 durometer; (2) a tensile strength of from
about 200 psi to about 800 psi; an elongation of from about 600% to
about 1200%; (3) a tear strength of from about 40 ppi to about 130
ppi; and (4) a compressibility and extensibility factor of up to
about 25%.
21. The implant of claim 1 wherein the implant is configured in the
form of a penis, testicle, or a breast.
22. The implant of claim 1 wherein the implant is configured in the
form of a breast.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The instant application is a continuation of U.S. Ser. No.
16/238,821 which was filed on Jan. 3, 2019 and which will issue on
Apr. 20, 2021 as U.S. Pat. No. 10,980,639. U.S. Ser. No. 16/238,821
claims priority to U.S. Ser. No. 62/702,062 filed Jul. 23, 2018 and
U.S. Ser. No. 62/779,825 filed Dec. 14, 2018. The aforementioned
applications are incorporated by reference for U.S. purposes.
BACKGROUND AND SUMMARY OF INVENTION
[0002] Cosmetic implants such as breast implants and penile
implants are growing in popularity. Similarly, prosthetic and other
medical devices are increasingly employed to treat or ameliorate
conditions. For both implants and other medical devices it is often
desired that they conform to existing tissue and/or mimic normal
anatomical movement such that they resemble the natural human or
animal body part or even have an enhanced appearance relative to
the natural human or animal body part. Unfortunately, implants and
devices made using conventional technology often results in an
implant or device which does not facilitate tissue expansion,
inhibits normal anatomical movement, and/or does not resemble a
natural body party. Thus, what is needed is an implant that
accomplishes one or more of the aforementioned desirable
characteristics.
[0003] Advantageously, the instant invention implants and medical
devices overcome the problems described above. The implants
typically comprise one or more biocompatible materials.
Advantageously, in some embodiments the one or more materials may
be selected or configured to facilitate tissue expansion while not
substantially inhibiting normal anatomical movement. The implants
also may advantageously resemble a natural body party or even have
an enhanced appearance relative to a natural body part. Thus, the
concepts of the instant invention are applicable to, for example,
breast implants, penile implants, testicular implants as well as,
incontinence devices such as male or female urethal continence
plugs.
[0004] The above-described concepts may be particularly useful with
respect to cosmetic penile implants because currently available
cosmetic penile enhancement devices suffer from a number of
limitations and deficiencies. Some comprise a rigid, inelastic
silicone block that increases the risk of external erosion, patient
discomfort, and an unnatural flaccid penile look and feel.
Infection rates are also arguably higher with currently available
cosmetic penile implants because none are antibiotic-coated or
antimicrobial-resistant. Additionally, the current cosmetic penile
implants are implanted using non-absorbable sutures near the dorsal
neurovascular bundle distally, risking penile devascularization and
denervation that can produce penile necrosis or reduced penile
sensation. Further, the rigid silicone block and non-absorbable
sutures prevent full penile elasticity during an erection that can
reduce potency and cause discomfort during an erection.
[0005] Accordingly, in one specific embodiment the instant
invention pertains to a penile implant. The penile implant
generally comprises a body having outer and inner surfaces and a
longitudinal axis and of a selected longitudinal length to be
aligned with the long axis of a penis. The body comprises a
cross-section perpendicular to the longitudinal axis of the body
having a wall thickness that tapers circumferentially in opposite
directions beginning from a maximum thickness along a dorsal
midline to a minimum thickness along ventral edges that form a
ventral opening. Advantageously, the penile implant comprises one
or more biocompatible materials selected or configured to
facilitate tissue expansion.
[0006] The improved cosmetic penile implant of the present
invention greatly reduces these untoward complications and provides
the patient with a safer, more comfortable, and more natural
cosmetic penile enhancement while safeguarding natural penile
sexual function. Thus, the cosmetic penile implant implanted
subcutaneously may be configured to replicate as nearly as possible
the natural human anatomy in shape, appearance, elasticity,
compressibility, texture, and feel.
[0007] These and other embodiments are described in detail
below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 illustrates a perspective view of an embodiment of a
penile implant.
[0009] FIG. 2 illustrates a side view of the implant shown in FIG.
1.
[0010] FIG. 3 illustrates a section view of a proximal end of the
implant shown in FIG. 2.
[0011] FIG. 4 illustrates a section view of a distal end of the
implant shown in FIG. 2.
[0012] FIG. 5 illustrates a distal end view of the implant shown in
FIG. 1.
[0013] FIG. 6 illustrates a proximal end view of the implant shown
in FIG. 1.
[0014] FIG. 7 illustrates a section view of the implant shown in
FIG. 5.
[0015] FIG. 8 shows a section of the natural anatomy of a
penis.
[0016] FIGS. 9A and 9B illustrates perspective views of each side
of an embodiment of a penile implant.
[0017] FIG. 10 illustrates various representative dimensions of
various size penile implants.
[0018] FIG. 11 illustrates representative mesh tab locations for
the penile implant shown in FIGS. 9A and 9B.
[0019] FIG. 12 illustrates Shore Hardness scale and representative
properties of various implants.
[0020] FIG. 13 shows representative mesh material options.
[0021] FIGS. 14A, 14B, and 14C illustrate penile implant location,
method, and sizing embodiments.
[0022] FIG. 15 shows various configurations of the internal pockets
of an implant core.
DETAILED DESCRIPTION OF THE INVENTION
General Implant--Description of Implants Methods of Making,
Materials, Configurations, Characteristics (Cosmetic and Physical),
Specific Implant Types
[0023] As described above, the implants and devices of this
invention may be suitable for animals or humans. The specific
material or materials employed will vary depending upon the
specific implant, application, desired characteristics, and the
like. In many applications the material employed will be
biocompatible, i.e., not particularly harmful to the tissue that is
near or in communication with the device or implant whether it be
human or animal tissue. The one or more materials are typically
selected, configured, or both to facilitate tissue expansion while
not substantially inhibiting normal anatomical movement and/or
substantially mimicking soft tissue characteristics of the natural
body part. Of course, the selected one or more materials and the
specific configuration will vary depending upon the specific
implant and desired tissue expansion and/or other results.
[0024] In one embodiment, to facilitate tissue expansion while not
substantially inhibiting normal anatomical movement the implant
comprises one or more biocompatible materials selected or
configured such that a measured property at a first location on
said implant is different than said same measured property at a
second location on said implant. Of course, using the present
invention a measured property may be different at three or four or
any number of locations on the implant. That is, the implant could,
for example, exhibit a gradient, i.e., an increase or decrease in
the magnitude of a measured property (e.g. hardness (durometer) and
other properties such as tensile strength; tear strength;
compressive strength; and elongation which also may be referred to
as extensibility or stretching or elasticity) that is observed in
passing from one point or location on the implant to another. This
can be accomplished in at least two general ways or a combination
of these two.
[0025] First, the material employed may be different at the first,
second, and/or other additional locations of the implant. That is,
the material or materials employed may vary at the first, second,
and/or other locations of the implant with respect to a property of
interest for the implant. That is the material or materials of the
implant may be different with respect to, for example, one or more,
two one or more, three one or more, four one or more, or even five
of the following properties: (1) hardness; (2) tensile strength;
(3) tear strength; (4) compressive strength; and (5)
elongation.
[0026] Making an implant having different properties at different
locations on the implant may be accomplished in any convenient
manner, e.g., by using different material of different properties.
Such manners will differ based on the implant, its properties,
materials employed, and desired characteristics.
[0027] Suitable methods may include molding, e.g., injection
molding, extrusion, rotomolding, transfer molding, compression
molding, blow molding, 3D printing, and the like. In general, any
suitable process may be employed so long as the desired material
with the desired property can be placed at the desired locations on
and/or within the implant. For example, if using injection molding
one might use a mold in the shape of the desired implant. The mold
may have multiple injection points, e.g., two or more, three or
more, four or more, or up to as many as necessary or desired. In
this manner different materials (or the same material with varying
properties) may be injected through each injection port. If
desired, there may be compartments within the mold but often
compartments are unnecessary as factors such as the different
injection points and timing of injection may control the ultimate
placement of the various materials. In this manner, the implant can
be designed or tailored to have different properties at different
locations or places on or within the implant. Thus, the desired
properties such as (1) hardness; (2) tensile strength; (3) tear
strength; (4) compressive strength; and (5) elongation can be
tailored throughout the implant by selecting the one or more
biocompatible materials such that a measured property at a first
location on said implant is different than said same measured
property at a second, third, fourth, or even additional locations
on said implant.
[0028] A second method of making an implant wherein a measured
property at a first location on said implant is different than said
same measured property at a second or even more locations involves
configuring the material within the implant to achieve this. This
second method can be used independent of the first method which
uses varying materials or a material that varies in properties.
Alternatively, the configuring described further below may be done
in in conjunction with the use of varying materials or the use of a
material that varies in properties.
[0029] In some embodiments of this second method, the one or more
materials are configured to comprise one or more internal pockets
within the implant. Such pockets are void spaces within the
implant. The design and configuration of the pockets or void spaces
will vary depending upon the type of implant and desired
characteristics. For example, the implant geometry, size, depth,
and/or location of the pockets can be configured to result in one
or more of the following: (1) reduce rigidity of at least a portion
of the implant, (2) reduce the total weight of the implant, (3)
increase elongation (elasticity or extensibility) of at least a
portion of the implant, or (4) increase compressibility of at least
a portion of the implant. As a specific example, the internal
pockets may comprise pockets to modify the measured compression or
elongation at different places on or within the implant, i.e.,
compression pockets, elongation pockets, or both. In a specific
embodiment, the implant may be configured with internal pockets
that, for example, permit elongation or stretching. For example, in
some embodiments, the implant may be configured with internal
pockets such that stretching of at least 10%, or at least 20%, or
at least 40%, or at least 60%, or at least 80%, or at least 100%,
or at least 150%, or at least 200% occurs compared to the same
implant substrate (e.g., same polymer in same shape) without
internal pockets. On the other hand, the implant may be configured
with internal pockets such that stretching of up to at most 500%,
or at most 450%, or at most 400%, or at most 350%, or at most 300%,
or at most 250% occurs compared to the same implant substrate
(e.g., same polymer in same shape) without internal pockets. By
stretching is meant to refer to either elongation in one direction
or compression in the other direction.
[0030] As stated above, the particular geometry of the internal
pockets may vary widely depending upon the desired results. In
particular embodiments, the implant may be designed such that the
internal pockets of the implant may be in a honeycomb (e.g.,
polygonal such as hexagonal), a zig zag (WWWWW), or even an
elliptical configuration. In this manner, the implant can be made
such that a measured property at a first location on said implant
is different than said same measured property at a second, third,
fourth, or even additional locations on said implant. For example,
the implant's hardness at a particular location will usually depend
at least in part upon the nature and volume of the pockets or voids
beneath the location. That is, the greater the volume of voids
beneath a particular implant location, the softer the implant may
feel at that particular location. Thus, an implant may have a dense
honeycomb at the distal end with a less dense honeycomb at the
proximal end or a gradient or graduated honeycomb densities leading
to different hardnesses and/or other properties over the length
and/or various dimensions of the implant. Likewise, the geometry,
size, depth, and/or location of the pockets beneath a particular
location also affect and/or determine the other properties of the
implant beneath that location, e.g., tensile strength; tear
strength; compressive strength; and elongation (extensibility or
elasticity). In this manner, the configuration of the pockets can
be tailored or designed to change the properties at various
locations on the implant. FIG. 15 shows various configurations of
the internal pockets of an implant core.
[0031] The desired configuration of the implant's pockets, if any,
may be accomplished in any convenient manner and such manners may
differ depending upon the type of implant, material(s) employed,
desired properties, and other factors. One way of configuring an
implant is through the use of injection molding wherein the mold
cavity may include a removable structure in the geometry of the
desired pockets so that when structure is removed pockets or voids
exist within the molded implant. A commonly used injection molding
method using a core, a cavity side A, and a cavity side B may be
employed. Dual or multiple extrusion, 3-D printing and other
methods may also be used to make the aforementioned implant
structures.
[0032] The specific material or materials employed for the implants
herein are not particularly limited so long as they are typically
biocompatible and can be made to have one or more, or two or more,
or three or more, or four or more, or all of the desired properties
(e.g., hardness, tensile strength; tear strength; compressive
strength; and/or elongation) in the desired ranges described herein
for the implant. Thermosets, thermoplastics, elastomers, or
combinations thereof may be employed. Useful thermoplastics may
include nylon, polyethylene, polypropylene, and polystyrene while
useful thermosets may include various epoxy resins and phenolic
resins in any form while preferred thermosets may include various
gel colloids. Silicone and polyurethane may be particularly useful
materials for some types of implants. Particularly preferred
materials include foams, either solid or semi-solid, closed cell
foams such as those comprising urethane, silicone, or mixtures
thereof.
[0033] Particularly preferred configurations for various implants
include those that comprise a wall having a varying wall thickness
over one or more dimensions of the implant. Another preferred
configuration is one in which the amount of materials employed
within the implant are changed over one or more dimensions in a
gradient such as by a changing or changed honeycomb structure. By
reducing the wall thickness or alternatively having more voids in
perhaps a honeycomb structure over the length of the implant the
hardness or other properties may be changed such the implant is
similar to natural tissue and/or allows normal physiological
movement while augmenting the size or otherwise enhancing the
appearance of the body part. In another embodiment the implant
comprises one or more biocompatible materials having both linear
and radial compression capability. This may assist in tissue
expansion and may also contribute to the implant being similar to
natural tissue and/or allowing normal physiological movement while
augmenting the size or otherwise enhancing the appearance of the
body part.
[0034] The specific properties of the implant may vary depending
upon the material(s) employed, their placement, and the
configuration, e.g., geometry, size, depth, or location of pockets,
if any. In one embodiment the implant comprises one or more
biocompatible materials wherein a specific location on the implant
and/or the material has a durometer range of from about 0, or from
about 10, or from about 20, or from about 30 up to at most about
70, or up to at most 60, or up to at most 50, or up to at most 40
durometer on the Shore A scale according to ASTM D2240-15.
[0035] Other useful properties of the implant that may be
determined by the material or configured as desired may include
elongation, tensile strength, tear strength, compressibility or
extensibility. Specifically, useful implant embodiments may
comprise wherein the implant comprises one or more biocompatible
materials wherein a specific location on the implant and/or the
material employed has a tensile strength of from at least about 200
psi, or at least about 300 psi, or at least about 350 psi up to at
most about 1000 psi, or up to at most about 800 psi, up to at most
about 700 psi, or up to at most 600 psi according to ASTM D412-06.
Similarly, the implant may comprise one or more biocompatible
materials wherein a specific location on the implant and/or the
material employed has an elongation of from at least about 400%, or
at least about 500%, or at least about 600%, or at least about
700%, or at least about 800%, up to about 1200%, or up to about
1100%, or up to about 1000% according to ASTM D412-06. Similarly,
the implant may comprise one or more biocompatible materials
wherein a specific location on the implant and/or the material
employed has a tear strength of at least about 40 pounds per inch
(ppi), or at least about 50 pounds per inch (ppi), or at least
about 60 pounds per inch (ppi), or at least about 70 pounds per
inch (ppi), or at least about 80 pounds per inch (ppi), up to about
200 ppi, or up to about 130 ppi, or up to about 120 ppi, or up to
about 110 ppi according to ASTM D624. The implants of the present
invention may also comprise one or more biocompatible materials
wherein a specific location on the implant and/or the material
employed has a compressibility and/or extensibility factor of from
at least 0, or at least 5, or at least 10, or at least 15, up to
about 20, or up to about 25%. Compression can be tested by, for
example, ASTM D395-03.
[0036] In other embodiments of the instant invention the implants
may comprise one or more biocompatible materials wherein a specific
location on the implant and/or the material employed has at least
one, or at least two, or at least three, or at least four or more
of the above-described properties.
[0037] The implants may comprise further materials depending upon
the desired properties and application. For example, the implant
may comprise hydrophilic or hydrophobic agents on the interior or
exterior of the implant. In one specific embodiment the implants
have a hydrophilic agent on the exterior such that the implant is
at least partially resistant to bacteria, viruses, and the like in
that they cannot adhere to the surface. Such hydrophilic agents are
not particularly limited and depend upon the application. As such
they may be selected from any compatible material and applied in
suitable amounts to achieve the desired effect.
[0038] Other suitable additives to the interior and/or exterior of
the implant comprise a material capable of releasing heat and/or a
material capable of absorbing heat. In this manner the implant or
portions of the implant may be made to be exothermic or endothermic
based on exposure to one or more stimuli.
[0039] As described above, the instant inventions are widely
applicable to any number of types of implants and/or prosthetic or
other medical devices. Specific embodiments may be particularly
applicable to penile implant, a testicular implant, a female
incontinence implant, a breast implant, or similar implants and
devices. More specifically, the instant inventions may be
particularly applicable to those applications wherein tissue
expansion is desired. Such applications include, but are not
limited to, e.g., applications wherein desired tissue expansion
includes being near a urinary meatus, a fossa navicularis, or a
bladder neck when, for example, said implant is intended for or
placed in a human. Particularly preferred applications may include,
for example, those wherein the implant may be a penile implant, a
male or female incontinence implant or plug, or a breast implant.
Of course, the method of placing, attaching, inserting, and/or
employing the implants of the instant invention will vary depending
upon the specific type of implant and the person or animal's
anatomy with which it will be employed. In most instances
conventional and known surgical techniques or concepts can be
employed with a given implant. A specific embodiment pertaining to
a cosmetic penile implant is described below.
Specific Penile Implant Embodiments
[0040] The following specific embodiments disclosed relate to
cosmetic penile implants and method of implanting. However, it
should be understood that the concepts, materials, properties,
methods of making, and other description above apply equally to
cosmetic penile implants. Similarly, the concepts, materials,
properties, methods of making, and other description specific to
the penile implant embodiment described below may also be
applicable to many other types of implants and/or prostheses.
[0041] FIG. 8 illustrates a cross-section of the natural penile
anatomy consisting of several distinguishable parts. The glans
penis is commonly referred to as the head of the penis. The skin 16
is the outer layer of the penis. The corpus cavernosum 10 are two
columns of spongy erectile tissue comprising the dorsum of the
penis bilaterally which, when filled with blood, cause an erection.
The corpus spongiosum 15 is a column of sponge-like tissue
comprising the medial ventrum of the penis surrounding the urethra
18 from the bladder neck to the glans penis which also fills with
blood during an erection, but does not contribute to the erection.
The paired corpora cavernosa 10 and the corpus spongiosum 15 are
enclosed within a tube of deep fascia 20 called Buck's fascia.
Buck's fascia 20 also surrounds the deep dorsal vein 22, and the
paired dorsal arteries and dorsal nerves 24 of the penis.
[0042] The cosmetic penile implant may have a body having a
longitudinal axis of a selected longitudinal length to be aligned
with the long axis of the penis. The body may have any length and
any diameter or width. In one embodiment, the body may have a
cylindrical cross section. In other embodiments, the body may have
an elliptical or oblong cross section. In yet other embodiments,
the body may have a cross section of any shape. The body has an
outer surface and an inner surface. The body may be formed as one
integral part. A cross-section perpendicular to the longitudinal
axis of the body may have a wall thickness that tapers
circumferentially in opposite directions beginning from a maximum
thickness along a dorsal midline to a minimum thickness along
ventral edges that form a ventral opening. The ventral edges may be
straight or scalloped edges. The body may be open at both its
proximal end (nearest to the base of the penis), as well as the
opposite distal end (nearest to the glans penis).
[0043] The body may also have a constant wall thickness in a
direction extending longitudinally from the body's proximal end to
the beginning of a distal portion at which point the wall thickness
tapers from the beginning of the distal portion to the body's
distal end. A constant wall thickness extending along a
longitudinal length of the body from the proximal end to the
beginning of the distal portion is preferred over a tapered wall
thickness because the constant wall thickness more closely matches
the natural anatomy of the penis. The distal portion has a tapered
wall thickness only for a short portion near the distal end of the
body (nearest the glans penis). The body may have all edges and
corners rounded, chamfered, or pillowed. The implant is configured
to have a size and shape adapted for subcutaneous implantation
between the exterior skin and adjacent Buck's fascia. When
implanted the device may extend from the base of the penis at its
proximal end to the glans penis at its distal end.
[0044] The body may be made of any type of polymer, elastomer,
rubber, composite material, or any other spongy or flexible or
compressive material that replicates as nearly as possible the
natural human anatomy in shape, appearance, elasticity,
compressibility, texture, and feel. The implant body material will
be as flexible, compliant and compressible to most closely simulate
normal penile tissue in a flaccid state while producing enhanced
flaccid penile length and girth. In one embodiment, the body may be
made of a silicone. In another embodiment, the body may be made of
polyurethane. The softness of the material forming the body of the
implant may have a Shore A softness of less than 25, or less than
20, or less than 15, or less than 12, or more preferably less than
10. A shore durometer measures hardness of a material, typically of
polymers, elastomers, and rubbers. High numbers in its scale
indicate a greater resistance to indentation, and thus harder
materials. Lower number indicate softer, more compressible or more
flexible materials. There are several scales of durometer, used for
materials with different properties. The two most common scales,
using slightly different measurement systems, are the ASTM D2240
type A and type D scales. The A scale is for softer materials,
while the D scale is for harder materials.
[0045] If desired, mesh tabs of from about 1 to about 2 cm in
length may be placed through the length of the lateral margins
spaced from about 0.75 cm to about 1.25 cm apart. The body may have
one or more embedded tabs, e.g., mesh tabs, protruding from its
proximal end, and one or more embedded mesh tabs protruding from
its distal end. The mesh tabs may protrude beyond the proximal end
and the distal end up to any distance. For example, the embedded
mesh tabs may protrude bilaterally (on both sides) up to 0.5 cm
beyond the distal end, or up to 1.0 cm beyond the distal end, or up
to 1.5 cm beyond the distal end, or greater. The embedded mesh tabs
may protrude bilaterally up 1.0 cm beyond the proximal end, or up
to 1.5 cm beyond the proximal end, or up to 2.0 cm beyond the
proximal end, or greater. The mesh tabs may be any shape and size,
such as, for example, rectangular or square with right angles at
edges, and are provided as a functional means for suturing the body
at both distal and proximal ends to Buck's fascia and the fibrous
tunical sheath of the corpus cavernosa, to support maintaining the
body in place and prevent longitudinal and/or rotational migration.
The mesh tabs are configured to receive tissue ingrowth and may be
made of any material and mesh size that supports and promotes
natural tissue ingrowth. For example, the mesh may be polyurethane
mesh. Or the mesh may be another other type of material commonly
used in reconstructive general, plastic, or urologic surgery as
will be understood by one of ordinary skill in the art. Absorbable
sutures may be used to fasten the mesh tabs to Buck's fascia and
the corpus cavernosa tunic. Suturing will be understood by one of
ordinary skill in the art. The mesh tabs may be formed integrally
with the body, or embedded within the body, or attached to it, or
attached between multiple layers of the body, or attached to the
body by other methods of attachment. The mesh tabs are located at
the proximal end and the tapered distal end as near the ventral
margin as possible. Mesh tabs are not located within or attached to
the body along or near the dorsal midline to avoid suturing or
tissue ingrowth near the dorsal neurovascular bundle, which would
risk denervation or devascularization of the penis both during
implantation or during any subsequent required explantation.
[0046] The body may have an antimicrobial surface coating that
contains an antimicrobial agent that inhibits the ability of
microorganisms to grow on the surface of the body. For example, an
antibiotic or antibacterial may coat the surface or be embedded
into the implant material and thereby potentially reduce the risk
of bacterial infections of the implant. In one embodiment, the body
may be dipped into an antibiotic or antibacterial agent to coat the
surfaces. In another embodiment, the body may be impregnated with
an antibiotic or antibacterial agent when the body is formed. The
antibiotic coating or impregnation of the body will be consistent
with bioprosthesis standards as will be understood by one
ordinarily skilled in the art. Any type of antibiotic or
antibacterial agent may be used. For example, in certain
embodiments, Rifampin and/or Minocycline may be used.
[0047] FIGS. 1-7 illustrate an embodiment of a penile implant 100.
FIG. 1 illustrates a perspective view of an embodiment of the
penile implant 100. FIGS. 2 and 7 illustrate side and cross section
views of the penile implant 100, respectively. The implant 100 has
a cylindrical body 110 having a longitudinal axis and of a selected
longitudinal length to be aligned with the long axis of the penis.
The cylindrical body 110 has an outer cylindrical surface 112 and a
smaller inner cylindrical surface 114. FIGS. 3 and 4 illustrate
cross-section views perpendicular to the longitudinal axis of the
cylindrical body 110. The cylindrical body 110 has a wall thickness
that tapers circumferentially in opposite directions beginning from
a maximum thickness along a dorsal midline 120 to a minimum
thickness along ventral edges 122 that form a ventral opening 124.
The ventral edges 122 are illustrated as scalloped, however they
may also be straight edges.
[0048] FIG. 5 illustrates a distal end view, FIG. 6 illustrates a
proximal end view of the penile implant 100. The cylindrical body
110 may be open at both its proximal end 116 (nearest to the base
of the penis), as well as the opposite distal end 119 (nearest to
the glans penis). The body 110 may also have a constant wall
thickness in a direction extending longitudinally from the body's
proximal end 116 to the beginning 117 of a distal portion 118 where
the wall thickness tapers from the beginning 117 of the distal
portion 118 to the distal end 119 of the cylindrical body 110. The
distal portion 118 has a tapered wall thickness from the beginning
117 of the distal portion 118 to the distal end 119 of the
cylindrical body 110 (nearest the glans penis). The cylindrical
body 110 may have pillowed or rounded edges 128 at both the
proximal end 116 and the distal end 119. The implant 100 is
configured to have a size and shape adapted for subcutaneous
implantation between the exterior skin 16 and adjacent to Buck's
fascia 20. The implant may extend from the base of the penis at its
proximal end to the glans penis at its distal end.
[0049] The cylindrical body 110 further includes embedded mesh tabs
128 that are located at its proximal end 116, and one or more
embedded mesh tabs 128 that are located at its distal end 119. The
mesh tabs 128 are configured to receive tissue ingrowth and provide
a functional means for suturing the cylindrical body at both distal
119 and proximal ends 116 to Buck's fascia 20 to keep the
cylindrical body 110 in place and prevent longitudinal and/or
rotational migration. Absorbable sutures may be used to fasten the
mesh tabs to Buck's fascia and the underlying tunic of the corpus
cavernosum. The mesh tabs 128 may be formed integrally with or
embedded within the cylindrical body 110, or attached to it, or
secured between multiple layers of the cylindrical body 110, or
secured to the cylindrical body 110 by another other methods of
attachment. The mesh tabs 128 are located at the proximal end 116
and distal end 119 as near the ventral edges 122 as possible. Mesh
tabs 128 are not located within or attached to the body 110 along
or near the dorsal midline to avoid suturing or tissue ingrowth
near the dorsal neurovascular bundle 22, 24, which would risk
denervation or devascularization of the penis.
[0050] The following methods may be used for implanting the
cosmetic penile implant. The cosmetic penile implant may be placed
through a peno-scrotal or ventral phalloplasty incision without an
abdominal incision being made and without associated surgical drain
placement. Through a peno-scrotal or ventral phalloplasty incision,
Buck's fascia overlying the fibrous tunic of the corpus cavernosa
is identified and the soft tissue attachments are released through
both blunt and sharp dissection. Care is taken to avoid disruption
of Buck's fascia along the dorso-lateral margins of the corpus
cavernosa to avoid injury to the underlying penile neurovascular
bundle, thereby avoiding risk of penile devascularization or
sensory denervation. Through this incision, the glans penis may be
retracted caudally, thereby inverting the penile shaft and
permitting direct inspection and additional dissection of the
distal penile shaft. The distal implant margin containing the mesh
tabs may then be secured lateral to the dorsal neurovascular bundle
using absorbable sutures, ensuring secure and proper placement of
the implant. Similarly, absorbable sutures may be used to secure
the proximal margin of the implant ventrally, permitting tissue
ingrowth at each position of the implant at all four quadrants.
This additionally secures the implant in the desired location and
reduces the risk of implant migration, malposition and erosion.
This surgical approach also facilitates, through direct inspection,
ventral placement of the implant lateral to the urethral margin
bilaterally, further ensuring not only proper implant placement,
but a more concealed and comfortable tapered lateral implant
margin. The wound and the implant can be copiously irrigated with
antibiotic solution and hemostasis achieved and confirmed before
the subcutaneous tissue is reapproximated, also with absorbable
sutures. The peno-scrotal skin is similarly reapproximated with
absorbable sutures providing a two-layered closure. The shaft is
then loosely wrapped with gauze and elastic adhesive, taking care
to avoid penile ischemia. The patient may be discharged the same
day following a brief recovery period with instructions to remove
the dressing in 24-48 hours. Cleansing of the wound daily may then
occur. Avoidance of sexual intercourse is advised until the one
month postoperative examination.
[0051] Another method of implanting the cosmetic penile implant may
be the methods that are taught by U.S. Pat. No. 4,202,530, which is
incorporated herein by reference in its entirety.
[0052] The inflatable penile implant to correct erectile
dysfunction may be subsequently implanted within the corpus
cavernosa, deep to the cosmetic penile implant, without meaningful
physical alteration to the cosmetic penile implant or compromise of
the intended purpose of the cosmetic penile implant. Similarly,
placement of the cosmetic penile implant subsequent to placement of
an inflatable penile implant is possible with either surgical
approach referenced above. Advantageously, there are no
restrictions to erection of the penis following cosmetic implant
placement given absorbable suture use, elasticity of the implant
body and only segmental use of mesh attachments off the dorsal
midline neurovascular bundle.
[0053] FIGS. 9A and 9B illustrate an embodiment of a penile implant
with a perspective view of each side. As shown in FIG. 10 the
penile implant, like the other implants herein, can be made in a
wide range of sizes and dimensions. Advantageously, the wall
thicknesses may vary over the length of the implant and/or the
geometry and configuration can be adjusted with pockets as
described above. By subtraction of material using thinner walls
and/or by adding more pockets, one can change the hardness over the
various dimensions of the implant. Thus, the hardness and other
properties may change from proximal to distal and vice versa, e.g.,
the distal portion may have a dense honeycomb structure while the
proximal portion is less dense. This assists in, for example,
providing augmentation while retaining physiological feel and
function. That is, the penile and other implants of the present
invention may mimic soft tissue more so than other implants which
may, for example, employ a bag-like or balloon like exterior with a
cavity filled with fluid-like material. In contrast, the implants
of the present invention may be comprised of a single material
configured with pockets to adjust the properties.
[0054] The penile and other implant may be attached in any
convenient manner. As described previously in some embodiments the
penile implant may comprise tabs for suturing the penile or other
implant to the body. If employed, then the tabs may be located at
any convenient location and be comprised of any biocompatible
material. FIG. 11 illustrates representative mesh tab locations for
the penile implant shown in FIGS. 9A and 9B while FIG. 13 shows
exemplary types of mesh material that may be employed.
[0055] As described in detail above, the implants, including the
penile implant, may be comprised of materials that exhibit various
ranges of properties, e.g., durometer, elongation, tensile, tear,
etc., at one or more different locations on the implant. FIG. 12
illustrates Shore Hardness scale and representative properties of
various implants such as the penile implant. FIGS. 14A, 14B, and
14C illustrate penile implant location, method, and sizing
embodiments. If course, if desired one or more of various other
features may be incorporated into the penile or other implants so
long as they don't substantially interfere with the function. A
non-limiting list of such features may include ribs, knobs, horns,
grooves, a radiopaque property, fluorescence or some other
illuminating property.
[0056] The claimed subject matter is not to be limited in scope by
the specific embodiments described herein. Indeed, various
modifications of the invention in addition to those described
herein will become apparent to those skilled in the art from the
foregoing description. Such modifications are intended to fall
within the scope of the appended claims.
* * * * *