US011432929B2

( 12 ) Elist
( United States Patent ( 10) Patent No .: US 11,432,929 B2
(45) Date of Patent : * Sep. 6, 2022
(54) PROSTHESIS FOR IMPROVED PENIS ( 56 ) References Cited
FUNCTION
U.S. PATENT DOCUMENTS
( 71 ) Applicant: James Elist , Beverly Hills , CA (US ) 1,383,944 A 7/1921 Hart
( 72 ) Inventor: James Elist , Beverly Hills , CA (US ) 2,899,957 A 8/1949 Briggs
(Continued )
( 73 ) Assignee : Menova International , Inc. , Beverly
Hills , CA (US ) FOREIGN PATENT DOCUMENTS
( * ) Notice: Subject to any disclaimer, the term of this CN 1291874 A 3/1999
patent is extended or adjusted under 35 CN 101848688 A 9/2010
U.S.C. 154 ( b ) by 38 days. ( Continued )
This patent is subject to a terminal dis OTHER PUBLICATIONS
claimer.
( 21 ) Appl . No .: 16 /434,182 Written Opinion in International Patent Application No. PCT /US /
2016/20881 , dated May 12 , 2016 ( 3 pages ) .
( 22 ) Filed : Jun . 7, 2019 (Continued )
( 65 ) Prior Publication Data Primary Examiner John P Lacyk
US 2020/0383788 A1 Dec. 10 , 2020 (74 ) Attorney, Agent, or Firm — Nixon Peabody LLP ;
US 2022/0015908 A9 Jan. 20 , 2022 Jeffrey L. Costellia
Related U.S. Application Data
( 57 ) ABSTRACT
( 63 ) Continuation - in -part of application No. 15 / 905,652 ,
filed as application No. PCT/US2016 / 020881 on A prosthesis is implanted subcutaneously within a human
( Continued ) penis, the prosthesis forming sides of an elongated longitu
dinal modified cylindrical shape, the sides hinged along a
( 51 ) Int . Ci . common abutment therebetween . A sheath is mounted
A61F 2/26 ( 2006.01 ) around the prosthesis' wall and a net sheeting is imbedded
A61F 5/41 ( 2006.01) under the surface of the prosthesis' wall providing a means
( 52) U.S. CI . to secure the sides ; restraining them to further secure a
CPC A61F 2/26 ( 2013.01 ) ; A61F 5/41 corpora cavernosa around the prosthesis is placed . When the
( 2013.01 ) ; A61F 2220/0008 (2013.01 ) ; A61F penis is erect it grows in girth thereby causing the sides to
2230/0069 ( 2013.01) diverge, forcing a press - rib against a deep dorsal vein of the
(58 ) Field of Classification Search penis, which results in restricting blood flow and maintain
CPC ...... A61F 2/26 ; A61F 2/02 ; A61F 2/04 ; A61F ing erectile rigidity and duration.
5/41 ; A61F 2005/415
See application file for complete search history . 19 Claims , 5 Drawing Sheets

3rd

- ??????? ?????? ???????? ???

TOA ...

????????? ? ? ? ? ? ?

90
 US 11,432,929 B2
Page 2

Related U.S. Application Data 10,350,070 B2 *

2003/02 12463 A1
7/2019 Elist
11/2003 Seo
A61F 2/26
Mar. 4 , 2016 , now Pat . No. 10,350,070 , which is a 2014/0031619 Al 1/2014 Moon
continuation of application No. 14 / 986,484 , filed on
Dec. 31 , 2015 , now Pat . No. 9,504,573 . FOREIGN PATENT DOCUMENTS
( 56 ) References Cited CN 103565572 A 2/2014
EP 2 853 239 4/2015
U.S. PATENT DOCUMENTS EP 2853239 A1 4/2015
JP A 1992-501372 3/1992
3,455,301 A 7/1969 Clark JP 2015-507481 A 3/2015
3,893,456 A 7/1975 Small WO WO 99/44550 9/1991
3,987,789 A 10/1976 Timm WO WO - 2005 /065598 7/2005
4,204,530 A 5/1980 Finney WO WO 2005/065598 A1 7/2005
4,267,829 A 5/1981 Burton WO WO 2010/059064 A1 5/2010
4,483,331 A 11/1984 Trick
4,523,584 A 6/1985 Yachia et al . OTHER PUBLICATIONS
4,566,446 A 1/1986 Fogarty
4,589,405 A 5/1986 Hemmeter Extended European Search Report in European Patent Application
4,602,625 A 7/1986 Yachia
4,628,914 A 12/1986 Everson No. EP 16880189.2 , dated Aug. 30 , 2018 ( 10 pages ) .
4,669,456 A 6/1987 Masters Notice to Submit Response in Korean Patent Application No. KR
4,773,403 A 9/1988 Daly 10-2017-7024560 , dated Feb. 28 , 2019 (4 pages ).
4,881,530 A 11/1989 Trick First Office Action in Chinese Patent Application No. CN
4,942,886 A 7/1990 Timmons 2016800080126 , dated Nov. 28 , 2019 ( 7 pages ) .
4,982,731 A 1/1991 Lue Notice for Reasons of Refusal in Japanese Patent Application No.
5,063,914 A 11/1991 Cowen JP 2017-541114 , dated Dec. 19 , 2019 (4 pages ) .
5,101,813 A 4/1992 Trick Preliminary Office Action in Brazilian Patent Application No. BR
5,250,020 A 10/1993 Bley 112018012587-3 , dated May 12 , 2020 (4 pages ).
5,263,981 A 11/1993 Polyak First Examination Report in Australian Patent Application No. AU
5,344,388 A 9/1994 Maxwell
5,445,594 A 8/1995 Elist 2016380684 , dated Nov. 24 , 2020 ( 5 pages ) .
5,512,033 A 4/1996 Westrum Notice to Submit Response in Korean Patent Application No. KR
D376,011 S 11/1996 Nunokawa 10-2019-70363245 , dated May 14 , 2021 ( 6 pages ) .
5,611,515 A 3/1997 Benderev Notice for Reasons of Refusal in Japanese Patent Application No.
5,669,870 A 9/1997 Elist JP 2020-157574 , dated May 31 , 2021 (4 pages ) .
5,895,424 A 4/1999 Steele Notice of Fulfillment Amendments in Qatari Patent Application No.
5,899,849 A 5/1999 Elist QA /201806 /00245, dated Feb. 3 , 2022 (4 pages ) .
6,015,380 A * 1/2000 Subrini A61F 2/26 Notice to Submit Response in Korean Patent Application No. KR
600/38 10-2022-7003332 , dated Mar. 7 , 2022 ( 3 pages ) .
6,475,137 B1 11/2002 Elist Mexican Office Action for Application No. MX / a /2018 /008170 ,
6,537,204 B1 * 3/2003 Elist A61F 2/26 dated Apr. 29 , 2022 ( 5 pages ) .
600/40 Kuwait Office Action for Application No. KW / P / 2018 /68, dated
6,749,558 B1 6/2004 Brintle Apr. 18 , 2022 ( 8 pages ).
7,584,757 B2 9/2009 Krakovsky Canadian Office Action for Application No. 2976141 , dated May 4 ,
7,628,812 B2 12/2009 Awengen 2022 (3 pages) .
8,986,193 B1 3/2015 Elist
9,320,832 B2 4/2016 Joseph
9,504,573 B1 * 11/2016 Elist A61F 2/26 * cited by examiner
U.S. Patent Se[D. 6, 2022
? Sheet 1 of 5 US11,432,929 B2

30

...:

1
.
FIG

rers

???

?
? k
U.S. Patent Sep. 6, 2022 Sheet 2 of 5 US 11,432,929 B2

Of
!
s
11
***
.

04
** 2
.
FIG
+

.
.

....

11447111|11111.*****

OC
U.S. Patent Sep. 6, 2022 Sheet 3 of 5 US 11,432,929 B2

*** .
..***.
...
...
.....**** . ...

FIG . 3

WWW

FIG . 4

FIG . 5
U.S. Patent Sep. 6, 2022 Sheet 4 of 5 US 11,432,929 B2

TS
FIG . 6

FIG . 7

venit 2
4)
un

FIG . 8
U.S. Patent Sep. 6, 2022 Sheet 5 of 5 US 11,432,929 B2

????

022
0 FIG
9
.

. 11:124131

o
6
 US 11,432,929 B2
1 2
PROSTHESIS FOR IMPROVED PENIS SUMMARY OF THE INVENTION
FUNCTION
The present invention teaches certain benefits in construc
CROSS - REFERENCE TO RELATED tion and use which give rise to the following objectives. A
APPLICATIONS 5 penile prosthesis may have a cylindrical, elongated body
providing a wall thickness varying circumferentially from a
This application is a continuation - in -part of U.S. appli- maximum thickness at its top surface, to a minimum thick
cation Ser. No. 15 / 905,652 , filed on Feb. 26 , 2018 , which is ness along its bottom surface . The wall thickness may
a U.S. National Stage of International Application No. further vary longitudinally from a maximum thickness at a
PCT/US2016 /020881, filed on Mar. 4 , 2016 , which is a 10 proximal end of the device to a minimum thickness at a
Continuation of application Ser. No. 14/ 986,484 , filed on distal end . The apparatus is preferably made of silicone
Dec. 31 , 2015 , each of which is hereby incorporated by rubber and has a length and size enabling subcutaneous
reference herein in its entirety. implantation around the corpora cavernosa providing suffi
cient rigidity for enabling coitus while still being flexible
BACKGROUND OF THE INVENTION 15 enough to be conveniently positioned when the penis is
flaccid .
Field of the Invention An objective of the described and claimed prosthesis is to
provide rigidity to the human penis so as to enable coitus.
A further objective is to provide an appropriate tapered
This invention relates generally to surgical prostheses for 20 appearance .
the enhancement of appearance and operation of organs, and
more particularly to a penile prosthesis enabling a damaged without removal objective
A still further is to enable surgical implantation
of existing organ portions or related tissues .
penis or poor penis function to be restored to a satisfactory A yet further objective is to prevent the prosthesis from
sexual function and /or aesthetic appearance. moving axially after being implanted .
Description of Related Art
25 A further objective is to provide a means for anchoring the
distal end of the prosthesis.
An important objective is to stem the flow of blood out of
A prosthesis for implantation into a penis to provide the penis during coitus .
rigidity and improve dimensions is known in the art. Such a Other features and advantages of the present invention
prosthesis may include an elongated , malleable rod portion 30 will become apparent from the following more detailed
which is housed within a generally tubular , physiologically description, taken in conjunction with the accompanying
inert plastic body. The malleable rod portion enables the drawings, which illustrate, by way of example , the prin
prosthesis to conform to a variety of shapes by bending or ciples of the invention .
twisting it . During intercourse the prosthesis will maintain
the penis in an erect state , and afterwards the penis may be 35 BRIEF DESCRIPTION OF THE DRAWINGS
positioned and maintained in a more convenient and com
fortable position . Finney, U.S. Pat . No. 4,204,530 describes The accompanying drawings illustrate the present pros
a prosthesis with aa sleeve for increasing the penile diameter, thesis invention as described . In such drawings:
and which includes a flexible sheet of soft, physiologically FIG . 1 is a proximal perspective view thereof;
acceptable material, the sheet being of sufficient length when 40 FIG . 2 is a proximal perspective view of one portion
formed in the general shape of a cylindrical sleeve to extend thereof;
from the glans penis to the base of the penis and of a width FIG . 3 is aa distal perspective view of aa sheath thereof;
which is insufficient to completely encircle the penis , but is FIG . 4 is aa side view of said sheath ;
sufficient to cover the corpora cavernosa . Improved rod -type FIG . 5 is a proximal end view of said sheath ;
penile prostheses may have a relatively stiff proximal por- 45 FIG . 6 is aa distal end view of said prosthesis shown in a
tion for positioning inside the corpora cavernosa adjacent convergent attitude;
the pubis for supporting the prosthesis, a longer relatively FIG . 7 is a proximal end view of said prosthesis shown in
stiff distal portion for positioning in the corpora cavernosa of said convergent attitude;
the pendulous penis , and a hinge separating the distal and FIG . 8 is a proximal end view of said prosthesis shown in
proximal portions. Masters , U.S. Pat. No. 4,669,456 50 a divergent attitude; and
describes a penile prosthesis which comprises an elasto- FIG . 9 is a cross - sectional view of a typical human penis .
meric rod and aa metal wire coil coaxially imbedded within
at least a portion of the rod . Subrini , U.S. Pat . No. 6,015,380 DETAILED DESCRIPTION OF THE
describes a prosthesis which can be used to increase penile INVENTION
volume . Moreira de Azeredo , WO 86/01398 describes a 55
penile rigidity prosthesis for the treatment of erectile impo- The above described drawing figures illustrate the inven
tence in men including at least one penile prosthesis com- tion , a penile prosthesis 10 , in at least one of its preferred
prising an elongated malleable cylindrical body adapted to embodiments, and is further defined in detail in this descrip
be surgically placed in the corpora cavernosa . tion . The penile prosthesis 10 may be made of silicone
The prior art teaches the use of aa subcutaneously placed 60 rubber or a like material and may be implanted subcutane
prostheses to rigidize the penis , but does not teach the use of ously into a human penis 5. FIG . 9 is a cross - section view
certain contours that provide structural advantages nor a illustrating the anatomy of penis 5 and showing in particular,
means for restricting flow through the dorsal vein, or a the dorsal vein 6a , the deep dorsal vein 6b , the dorsal artery
means for preventing axial movement or sliding of the and nerve 6c , the corpus cavernosum penis 6d , the profunda
prosthesis relative to the penis' long axis . The present 65 artery be , the corpus spongiosum and urethra 6f, the tunica
invention fulfills these needs and provides further related albuginea 6g, the intercavernous septum of buck's fascia 6h ,
advantages as described in the following summary . the tunica albuginea of corpus cavernosum penis 6i , the
 US 11,432,929 B2
3 4
buck's fascia 6j, the dartos fascia 6k, and the outer lying skin skin 61 and in contact with buck's fascia 6h . Prosthesis 10
61 which is the outer layer of penis 5 and under which penile may extend from the base of penis 5 at its proximal end 20
prosthesis 10 is inserted . to the glans penis at distal end 30. Both inside surface 50 and
Prosthesis 10 is well adapted by its elongated and longi- outside surface 60 may have a silicon net sheeting 70
tudinally tapered modified cylindrical shape for subcutane- 5 imbedded just under these surfaces as shown in FIGS . 1 and
ous implantation within human penis 5. Penile prosthesis 10
has opposing proximal 20 and distal 30 ends as shown in
2 , wherein net sheeting 70 may extend continuously over
and /or under both portions 10A , 10B and thus may function
FIGS . 1 and 2 , and is comprised of aa wall 12 of a modified as a hinge between the portions along abutment joining line
cylindrical shape whereby its portions 10A and 10B are 100. Portions 10A and 10B may therefore be moved between
flexibly joined and movable between relative convergent 10 the two attitudes shown in FIGS . 7 and 8. Prosthesis 10 ,
( FIGS . 1 , 6 and 7 ) and divergent (FIG . 8 ) respective posi when in place around buck's fascia 6j, may be anchored
tions . The flexibly joining feature may be by any hinging using sutures joining net sheeting 70 to buck's fascia 6j or
means including a web of the same material as prosthesis 10 . to tunica albuginea 6g , or both .
Any other hinging mechanism may be employed as well .
In prosthesis 10 a press -rib 15 may be located between The thicker portion of wall 12 at proximal end 20 , when
15 placed
portions 10A and 10B as shown in FIGS . 6 , 7 and 8 whereby adjacent to the base of the penis (not shown ) provides
press -rib 15 may be in a position for pressing downwardly the advantage of improved rigidity of prosthesis 10 and
onto a deep dorsal vein 6b of penis 5 as shown in FIG . 8 . penis 5 , and the thinner portion of wall 12 at distal end 30 ,
This may occur when engorged penis 5 becomes erect which adjacent to the glans penis (not shown ), allows for improved
drives portions 10A and 10B divergently as shown in FIG . 20 movement of the glans penis for more convenient coital
8 and which in turn causes press -rib 15 to bear down on vein adjustment. The uniform taper from proximal end 20 to
6b thereby restricting venus blood flow and enabling main- distal end 30 provides improved flexibility of penis 5 when
tenance of an erect state of penis 5. Clearly , convergent and flaccid . The thicker wall 12 along joining line 100 provides
divergent attitudes of separate portions 10A and 10B are greater structural strength where the highest compressive
controlled by the erectile states of penis 5 . 25 forces occur during coitus . The circumferential taper pro
As shown in 110 , prosthesis 10 may have one or more vides improved flexibility of penis 5 and a more natural
sheaths 110 of the type shown in FIGS . 3 , 4 , and 5 , or of penile conformation and appearance as well as improved
similar shape and construction . Such a sheath 110 may be blood flow since cylindrical wall 12 may be quite thin near
constructed of aa sterile gauze fabric or similar material and the glans penis, distal end 30 as best shown in FIG . 2. The
may be mechanically secured around prosthesis 10 as 30 important overall result of the conformation of prosthesis 10
shown . Prosthesis 10 may be distally positioned as shown in is that it uses a relatively small amount of material in its
FIG . 1 , or may be proximally positioned (not shown) or may structure while achieving sufficient rigidity and blood flow .
be positioned in multiple locations around sheath 110. Such The use of net sheeting 70 provides a wide range of choices
mechanical securement may include at least partially imbed as to placement of sutures. The use of longitudinally sepa
ding said sheath 110 within cylindrical wall 12. Other 35 rated portions 10A, and 10B facilitates implantation and
mechanical securements may be applied in addition or provides the opportunity to use asymmetrical portions as
alternately , including the use of sutures 112 , adhesives and may be necessary for repair of a damaged or a misshapen
other well -known surgical attachment prerogatives. penis 5. The space between the bottom longitudinal edges 90
As shown in FIGS . 1 and 2 , the thickness of cylindrical allows penis 5 to expand without restraint as shown in FIG .
wall 12 may vary smoothly between proximal 20 and distal 40 8 .
30 ends , wherein said thickness of cylindrical wall 12 may The interior space within cylindrical wall 12 is preferably
be greatest at proximal end 20. The outside diameter of oblate , as is the human penis 5 with height greater than width
cylindrical wall 12 may vary smoothly between proximal as shown in FIGS . 6 and 7 with a preferred ratio of height
and distal ends 20 , 30 and may be greatest at proximal end to width of approximately 1.12 . It has been found that this
20. Clearly this configuration of cylindrical wall 12 is 45 form enables improved blood flow as well as a more
important for matching the anatomical aspects of penis 5 and comfortable fit to the shape of penis 5 .
also for structural integrity. As shown in FIGS . 1 and 6-8 FIG . 6 shows prosthesis 10 as viewed from its proximal
cylindrical wall 12 must be longitudinally discontinuous end 20 looking axially toward the distal end 30 while FIGS .
along bottom edges 90 in order to be able to insert prosthesis 7 and 8 show prosthesis 10 as viewed from the distal end 30
10 around penis 5 and also to enable divergence of portions 50 looking axially toward the proximal end 20. In these two
10A and 10B . figures, deep dorsal vein 6b is shown in dashed lines as
Prosthesis 10 may have a cylindrical body 10 of a selected located under press - rib 15 wherein FIG . 7 represents pros
longitudinal length aligned with the long axis 4 of penis 5 , thesis 10 with a flaccid penis 5 while FIG . 8 represents an
and may be open at both its proximal end 20 (nearest to the erect or engorged penis 5. It is shown that press - rib 15
testacies ) , as well as at its opposite distal end 30 (nearest to 55 compresses deep dorsal vein 6b to slow outward venus
the glans penis) as shown in FIG . 1. Prosthesis 10 may have blood flow during an erect penis 5 .
an inside surface 50 and an outside surface 60 and may be While the invention has been described with reference to
formed as a single integral part with two joined portions preferred embodiments, it is to be understood by those
10A , 10B or alternately it may be formed as two separate skilled in the art that the invention is not limited thereto .
portions 10A , 10B which may be later joined together as 60 Rather, the scope of the invention is to be interpreted only
shown in FIG . 1. Portions 10A , 10B may be mirror images in conjunction with the appended claims .
of each other as shown and may be joined prior to or during
implantation into penis 5. The implantation process is taught What is claimed is :
in Finney, U.S. Pat . No. 4,202,530 which is hereby incor- 1. A prosthesis adapted for subcutaneous implantation
porated into the present application by reference. Thus, it is 65 within aa human penis having opposing proximal and distal
clear that prosthesis 10 can be formed to have a size and ends, wherein said prosthesis comprises a substantially
shape adapted for subcutaneous implantation below exterior cylindrical wall wherein portions of said wall are adapted to
 US 11,432,929 B2
5 6
be movable relative to each other between relative conver- be movable relative to each other between relative conver
gent and divergent positions ; and gent and divergent positions, and
at least one sheath secured to the wall . at least one fabric piece positioned at a location at the wall
2. The prosthesis of claim 1 wherein a press - rib located and configured to be sutured to the human penis at a
between two of said portions is positioned for pressing 5 corresponding location .
against a deep dorsal vein of said penis when said prosthesis 13. The prosthesis of claim 12 wherein the at least one
is subcutaneously implanted within said human penis. fabric piece is a gauze fabric .
3. The prosthesis of claim 1 wherein said at least one fabric 14. The prosthesis of claim 12 wherein the at least one
sheath is at least partially imbedded within said wall . piece is aa sheath .
10 15.
4. The prosthesis of claim 1 wherein a thickness of said prosthesis A method for improving penis function using a
wall diminishes smoothly between said proximal and distal , the method comprising:
ends and wherein said thickness of said wall is greatest at subcutaneous implanting the prosthesis within a human
said proximal end . penis, the prosthesis having opposing proximal and
5. The prosthesis of claim 1 wherein an outside diameter 15 distal ends , the prosthesis including a substantially
of said wall diminishes smoothly between said proximal and cylindrical wall wherein two portions of said wall are
distal ends and wherein said diameter of said wall is greatest adapted to be movable relative to each other between
at said proximal end . relative convergent and divergent positions ; and
6. The prosthesis of claim 1 wherein said wall is longi causing a third portion of the wall located between said
tudinally discontinuous. two portions to press against a deep dorsal vein of said
7. The prosthesis of claim 1 further comprising a net 20 human penis, wherein the third portion is a press - rib.
sheeting imbedded under aa surface thereof. 16. The method of claim 15 wherein a thickness of said
8. The prosthesis of claim 7 wherein said net sheeting is and cylindrical wall diminishes smoothly between said proximal
functional as a hinge between said portions of said wall . distal ends and wherein said thickness of said cylindrical
9. The prosthesis of claim 1 wherein an interior surface of 25 wall17.isThe
greatest at said proximal end.
method of claim 15 wherein the press - rib located
said wall defines an oblate space there below . is positioned for pressing against the deep dorsal vein of said
10. The prosthesis of claim 1 wherein the sheath com penis when said prosthesis is subcutaneously implanted
prises a fabric material. within said human penis.
11. The prosthesis of claim 1 wherein the at least one 18. The method of claim 15 wherein the prosthesis has a
sheath includes a gauze layer.
12. A prosthesis adapted for subcutaneous implantation 30 net19.sheeting imbedded under a surface thereof.
The method of claim 18 wherein said net sheeting is
within a human penis having opposing proximal and distal functional as a hinge between said portions of said wall .
ends, wherein said prosthesis comprises a substantially
cylindrical wall wherein portions of said wall are adapted to * *