U.S. patent application number 15/076197 was filed with the patent office on 2016-09-22 for method and system for circumcision.
The applicant listed for this patent is Circ MedTech Ltd.. Invention is credited to Oren Fuerst, Ido Kilemnick, Shaul Shohat.
Application Number | 20160270811 15/076197 |
Document ID | / |
Family ID | 43033407 |
Filed Date | 2016-09-22 |
United States Patent
Application |
20160270811 |
Kind Code |
A1 |
Fuerst; Oren ; et
al. |
September 22, 2016 |
METHOD AND SYSTEM FOR CIRCUMCISION
Abstract
A system for effecting ischemic necrosis in a foreskin of a
penis includes an inner ring having an inner surface comprising an
inner diameter and an outer surface comprising an outer diameter
and at least one circumferential groove; and an outer ring
configured to substantially fit around the circumferential groove
of the inner ring, wherein the inner ring is configured to fit to a
portion of a glans of the penis that lies between an inner surface
of the foreskin and the glans of the penis and the at least one
outer ring is configured to fit an outer surface of the foreskin,
the inner ring and the outer ring thereby compressing the foreskin
in the circumferential groove with a compression force, and wherein
the compression force is sufficient to effect ischemic necrosis in
the foreskin.
Inventors: |
Fuerst; Oren; (Ramat
Hasharon, IL) ; Kilemnick; Ido; (Herzelia, IL)
; Shohat; Shaul; (Kfar Haoranim, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Circ MedTech Ltd. |
Tortola |
|
VG |
|
|
Family ID: |
43033407 |
Appl. No.: |
15/076197 |
Filed: |
March 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14615926 |
Feb 6, 2015 |
9289217 |
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15076197 |
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13383964 |
Mar 29, 2012 |
8974471 |
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PCT/IL10/00568 |
Jul 15, 2010 |
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14615926 |
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61348129 |
May 25, 2010 |
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61300525 |
Feb 2, 2010 |
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61244157 |
Sep 21, 2009 |
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61225947 |
Jul 16, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0073 20130101;
A61B 90/96 20160201; A61H 23/02 20130101; A61B 2090/061 20160201;
A61H 19/32 20130101; A61H 39/002 20130101; A61B 2017/00867
20130101; A61B 17/1322 20130101; A61M 35/00 20130101; A61B
2017/12018 20130101; A61B 17/326 20130101; A61B 90/98 20160201;
A61B 17/12009 20130101 |
International
Class: |
A61B 17/326 20060101
A61B017/326; A61B 17/12 20060101 A61B017/12 |
Claims
1. A method for circumcising a foreskin of a penis, comprising:
positioning at least one inner ring over a portion of a glans of
the penis that lies between an inner surface of the foreskin and
the glans of the penis; positioning at least one outer ring around
an outer surface of the foreskin, thereby applying a compression
force over the foreskin between the inner ring and the outer ring,
the compression force being sufficient to effect ischemic necrosis
of the foreskin; and removing necrotic foreskin.
2. The method of claim 1, comprising positing the outer ring
directly over the outer surface of the foreskin.
3. The method of claim 1, comprising using a deployment element for
positing the outer ring over the outer surface of the foreskin.
4. The method according to claim 1, wherein the compression force
is substantially between a pressure range of 0.1-20
atmospheres.
5. The method according to claim 1, comprising retracting the
foreskin sufficiently to reveal at least a portion of the glans of
the penis before positioning the inner ring around the portion of
the glans of the penis.
6. The method according to claim 1, comprising pulling retracted
foreskin over the inner ring after the positioning of the inner
ring around the portion of the glans of the penis.
7. The method according to claim 1, comprising stretching an
opening of the foreskin sufficiently to insert inner ring through
the opening before positioning the inner ring around the portion of
the glans of the penis.
8. The method according to claim 1, comprising vertically
positioning the inner ring through the opening.
9. The method of claim 1, wherein the inner ring is a rigid or semi
rigid ring element comprising an inner surface comprising an inner
diameter; and an outer surface comprising an outer diameter and at
least one circumferential groove and the outer ring is elastic and
is positioned to substantially fit around the circumferential
groove of the rigid or semi rigid ring.
10. A system for effecting ischemic necrosis in a foreskin of a
penis, comprising an inner ring comprising an inner surface
comprising an inner diameter and an outer surface comprising an
outer diameter and at least one circumferential groove; and an
outer ring being configured to substantially fit around the
circumferential groove of the inner ring, wherein the inner ring is
configured to fit to a portion of a glans of the penis that lies
between an inner surface of the foreskin and the glans of the penis
and the at least one outer ring is configured to fit an outer
surface of the foreskin.
11. The system of claim 10, wherein the inner diameter of the inner
ring in a relaxed state is at least slightly larger than a diameter
of a shaft of the penis; wherein a diameter of the at least one
outer ring in a relaxed state is at least substantially equal to
the diameter of the shaft of the penis.
12. The system of claim 10, wherein the outer ring is fitted around
the circumferential groove to apply a compression force, the
compression force being substantially between a pressure range of
0.1-20 atmospheres.
13. The system of claim 10, wherein the at least one
circumferential groove has an asymmetrical cross sectional
shape.
14. The system of claim 10, wherein a radial direction of the at
least one circumferential groove is perpendicular to a longitudinal
axis of at least one of the inner ring and the outer ring.
15. The system of claim 10, comprising a deployment element
configured to hold the at least one outer ring in a stretched form
and for releasing the at least one outer ring over a portion of the
foreskin and for fitting into the at least one circumferential
groove of the inner ring, once the inner ring is placed around a
portion of the penis.
16. The system of claim 15, wherein the deployment element
comprises at least three flanges, each one of the at least three
flanges substantially located around a circumference of the
deployment element, such that the outer ring is stretched around
the at least three flanges, in a polygon shape.
17. The system of claim 10, wherein the inner ring is a rigid or
semi rigid ring and the outer ring is elastic.
18. A system for effecting ischemic necrosis in a foreskin of a
penis, comprising: a rigid or semi-rigid ring, the rigid or
semi-rigid ring comprising an inner surface comprising an inner
diameter; and an outer surface comprising an outer diameter and at
least one circumferential groove; at least one elastic ring being
configured to substantially fit around the circumferential groove
of the rigid or semi rigid ring; and a deployment ring configured
to hold the at least one elastic ring in a stretched form and for
releasing the at least one elastic ring over a portion of the
foreskin and for fitting into the at least one circumferential
groove of the rigid ring, once the rigid ring is placed around a
portion of the penis.
19. The system of claim 18, wherein the elastic ring is fitted
around the circumferential groove to apply a compression force, the
compression force being substantially between a pressure range of
0.1-20 atmospheres.
20. The system of claim 18, wherein the inner diameter of the rigid
or semi-rigid ring in a relaxed state is at least slightly larger
than a diameter of a shaft of the penis; wherein a diameter of the
at least one elastic ring in a relaxed state is at least
substantially equal to the diameter of the shaft of the penis; and
wherein the rigid or semi-rigid ring is placed around a first
surface of the foreskin.
Description
RELATED APPLICATIONS
[0001] The present application is a Continuation of application
Ser. No. 14/615,926, filed on Feb. 6, 2015, which is a Continuation
of application Ser. No. 13/383,964, filed on Jan. 13, 2012, which
is a national phase filing under 35 U.S.C. 371 of International
application No. PCT/IL10/00568, filed on Jul. 15, 2010, which
claims the benefit of and priority to Provisional application No.
61/225,947, filed on Jul. 16, 2009, Provisional application No.
61/244,157, filed on Sep. 21, 2009, Provisional application No.
61/300,525, filed on Feb. 2, 2010, and Provisional application No.
61/348,129, filed on May 25, 2010, all of which are incorporated
herein by reference in their entirety.
BACKGROUND OF THE DISCLOSED TECHNIQUE
[0002] The foreskin of a penis is an excess of skin, located
proximate to the distal end of the penis, also referred to as the
prepuce. The foreskin substantially covers the head of the penis,
also known as the glans of the penis, the glans penis or simply the
glans. Circumcision is a surgical operation in which either a
portion or all the foreskin of the penis is removed. Male
circumcision is one of the most common surgical procedures in the
world and has been performed for ritualistic as well as hygienic
reasons since ancient times. Nowadays, it may be performed for
clinical reasons or to comply with religious or cultural practices
(also known as non-therapeutic circumcision). Non-therapeutic
circumcisions are generally performed in a religious or cultural
community by general practitioners and non-clinicians.
Approximately a third of human males worldwide receive a
circumcision at some point in their lives. Circumcision has
traditionally been performed either immediately after birth, during
childhood, during adolescence or occasionally on young adults
(i.e., after the teenage years).
[0003] The human immunodeficiency virus (herein abbreviated HIV) is
a virus which causes AIDS, a deadly disease which has claimed more
than 25 million lives worldwide since its discovery in 1981.
Approximately 2 million people worldwide are infected with HIV
every year, wherein roughly two thirds of those infected with HIV
live in Sub-Saharan Africa. More than 1 million deaths per year
occur worldwide as a result of AIDS. Various worldwide attempts to
reduce infection and spreading rates of HIV, for example through
massive safer sex education programs and free condom distribution
points, have not significantly reduced infection rates and can be
considered partially successful in reducing the spread of HIV
worldwide. Prior art randomized controlled studies as well as
epidemiological studies have shown that circumcision can
significantly reduce the risk of infection with HIV in males. One
possible explanation of the results of such studies is that the
skin cells of which the foreskin is constructed have less
protection to diseases and infections than skin cells on other
parts of the body. Thus, the skin cells of the foreskin are more
prone to diseases and infections which may be transmitted by sexual
relations when the foreskin is stretched and its skin cells are
revealed. Based on these studies, the World Health Organization
(known as the WHO) and the Joint United Nations Programme on
HIV/AIDS (known as UNAIDS) have published position papers
substantially recommending large scale circumcision of adult males
worldwide living in regions and amongst populations having higher
rates of HIV infection, i.e., HIV at risk regions and populations.
These position papers include "Male circumcision: Global trends and
determinants of prevalence, safety and acceptability," published by
the WHO and UNAIDS in 2007, ISBN 978 92 4 159616 9 (WHO), and "Male
Circumcision and HIV Prevention: Research Implications for Policy
and Programming--Conclusions and Recommendations," a WHO/UNAIDS
Technical Consultation presented in Montreux, Switzerland, on Mar.
6-8, 2007. In addition, other large governmental bodies have put
forth possible biological explanations linking circumcision to
reduction in HIV infection rate. One such biological explanation
can be found on the website of the U.S.'s Centers for Disease
Control and Prevention, at
http://www.cdc.gov/hiv/resources/factsheets/circumcision.htm. In
particular, the published papers of the WHO and the UNAIDS cited
research which showed that the risk for infection of HIV is lowered
by 44%-71% in circumcised men. The WHO has thus recommended
circumcision to be incorporated among the main strategic tools
countries and healthcare authorities should consider in order to
reduce the spread of HIV.
[0004] One traditional method for performing circumcision is by
surgically removing the foreskin after physically pulling the
foreskin over the glans. In such methods, the foreskin is removed
while it is still a live tissue, usually causing bleeding. In some
cases, due to religious considerations, blood may be drawn even if
bleeding does not occur. Such methods may involve hemorrhaging and
a relatively long period of healing of the incision (e.g., up to a
few weeks), while inducing sustainable pain in an individual. In
most cases suturing is required when such a procedure is performed
on adult males. Such methods, referred to also as a mini-surgery,
can incur substantial costs on an individual undergoing such a
procedure as well as on organizations conducting circumcisions on a
large scale (such as national public health ministries). In
addition, when the above mentioned circumcision procedure is
performed on a large scale (i.e., for a large number of individuals
such as thousands of individuals), such mini-surgeries may require
many resources, including trained surgical personnel, a clean and
sterile surgery environment as well as the availability and
administration of local anesthesia. Otherwise, serious side effects
may be incurred on individuals undergoing such procedures. In
general, such methods are recognized as not being scalable for mass
circumcision campaigns, in particular in areas where medical
facilities may be sparse or not available and where skilled
personnel is scarce. It is therefore desirable to have a
circumcision device that is scalable for mass circumcision and is
also associated with as little pain as possible since perceptions
of pain will substantially reduce the willingness (also known as
the compliance level) of males to undergo circumcision.
[0005] Other methods and devices for performing circumcision are
known in the art. Such methods may require anesthesia, sutures,
skilled personnel, may not be bloodless and may not be scalable for
mass circumcision campaigns. One such method for performing a
circumcision is shown on the website
http://www.circ-ring.de/us/circ ring english.html (owned by the
company Circ-Ring International and known commercially as the
Zhenxi Ring), which discloses a device for performing a
circumcision by applying the foreskin to a ring, and then clutching
the foreskin with a tight fastening portion. Other variants of this
method are known and are described below. In such a manner, the
foreskin is tightly compressed and blood is prevented from flowing
therein. The fastening portion is an enclosing clamp fastened by a
screw portion. Excess skin (i.e., the foreskin) is removed using a
scalpel or another sharp implement. As the foreskin is tightly
compressed when the ring is placed around the penis, a local
anesthesia is substantially required when the fastening portion is
fastened and tightened around the penis to reduce any feelings of
pain the individual may experience in his penis while the device is
placed on his penis. As the ring fits securely around the penis in
a flaccid state, pain may be experienced by the individual during
an erection, such as erections which may occur during sleep.
[0006] A similar device to the Zhenxi Ring is disclosed in PCT
International Publication No. WO 2007/022730A1 (also known
commercially as the ShangRing and available on the website
www.snnda.com). The compression mechanism of this device as well as
the cutting of the excess skin when it is deployed on a penis are
likely to make the removal process of the device painful, typically
requiring the application of local anesthesia during placement of
and removal of the device, as well as other additional procedures
such as soaking the area adjacent to the device in iodine prior to
removal of the device. In addition, use of this device, which
includes an inner ring, may involve pain while the device is on an
individual's penis, such as during erections occurring in the
individual while the individual is asleep. Pain associated with use
of the ShangRing as well as mechanisms for dealing with such pain
are discussed in the following journal articles: "Clinical
application of a new device for minimally invasive circumcision" to
Peng et al., published in the Asian Journal of Andrology 2008,
10(3), pp. 447-454 and "Adult Male Circumcision Using the Chinese
Shang Ring: Results of 328 Cases and a Recommended Standard
Surgical Protocol in China" to Cheng et al., published in the
National Journal of Andrology (China) July 2009, 15(7), pp.
584-592. The Peng article suggests prescribing medication having
anti-libido attributes, such as oral diethylstilbestrol, to prevent
erections while an individual is asleep. The Cheng article suggests
making small incisions along the edge of the foreskin on the
underside of the ring to minimize pain during nocturnal erections.
Such incisions could increase the risk of infection in live skin
tissue. Both suggestions just mentioned involve pain and possible
risks related to the ring being too tight in certain circumstances.
In addition, part of the procedure of using the ring involves
making incisions in tissue that is not dead. Such incisions may
involve an amount of bleeding and could potentially lead to
infections.
[0007] U.S. Pat. No. 4,491,136 issued to LeVeen and entitled
"Disposable Circumcision Device," is directed to a device for
performing circumcision. The device includes a male and a female
member. The male member is a tubular support having an annular
groove. The female member is a clamp or an elastic ring, adapted to
fit over the annular groove. The foreskin is stretched over the
male member. The female member is then applied over the annular
groove, compressing the foreskin along the groove. This action
traps the foreskin between the two members. The excess foreskin is
then cut off and the male member is removed from beneath the ring
of the female member, forcing the cut end of the foreskin to be
prevented from bleeding. After the ends of the foreskin have
healed, the female member and rings are removed in a few days time.
The device of LeVeen enables the ends of the foreskin to heal after
the excess foreskin is cut off, which reduces the need for
suturing. At the same time, this device still involves a surgical
procedure of excising the foreskin while it is still a live tissue.
In addition, the mechanism of trapping the foreskin between the two
members does not enable natural detachment of the foreskin, thereby
possibly causing pain to the individual while the device is
deployed, used and then removed.
[0008] U.S. Pat. No. 5,269,788 issued to Nelson, III, and entitled
"Adjustable Hemostatic Circumcision Dressing and Method of its
Use," is directed to a device for performing circumcision. The
device includes an inner arcuate member having a pair of ends, an
elongated hollow connector piece and an outer arcuate grooved
member. The inner member is positioned between the prepuce and
shaft of a penis parallel to the corona of the glans of the penis.
The hollow connector piece receives the pair of ends of the inner
member. The outer arcuate grooved member is positioned over and
encompasses the prepuce (i.e., foreskin), when it is pulled up over
the inner member. The groove is disposed about the inner periphery
of the outer member. The inner member press-fits into the outer
member groove when the members are brought into mating
relationship, with the foreskin held there between. A crushing
action is thereby exerted upon the foreskin, causing hemostasis.
After the application of the outer member, the foreskin is excised
with a sharp instrument such as a scalpel or scissors or with a
surgical cautery. The inner and outer members, securely in
position, act as both a line of sutures and a sterile dressing for
the circumcision. Between the members, pressure necrosis and
healing occur in the course of approximately two to three weeks. On
a return visit to a physician, the outer and inner members are
removed to reveal the healed circumcision. The device of Nelson,
III, requires a surgical removal of the foreskin at the time the
device is deployed. In general, an individual may feel pain when
such a device is used unless anesthesia is applied to the area of
the penis surrounding the foreskin. In addition, this device
requires a sterile environment as well as surgical tools to excise
the foreskin at the time the device is deployed. As the foreskin in
this device is excised while still a live tissue, an increased risk
is involved in healthy skin tissue being incorrectly excised.
[0009] U.S. Pat. No. 7,303,567 issued to Smith, and entitled
"Circumcision Device," is directed to a device for performing a
circumcision. The device includes a ring, a bridge and a handle.
The ring has a tapered interior surface, an open anterior end, an
anterior opening defined by the interior surface at the anterior
end, an open posterior end and a posterior opening defined by the
interior surface at the posterior end. The posterior opening is
larger than the anterior opening. The ring also includes an
exterior surface and a groove circumferentially defined around the
exterior surface adjacent to the anterior end. The bridge extends
over the anterior opening and is fixedly connected to the anterior
end at circumferentially spaced points thereof. The handle is
fixedly but frangibly connected to the bridge at a junction between
the handle and the bridge. The handle extends longitudinally and
outwardly from the junction, being structurally weaker adjacent to
the junction than to any other portion of the handle. The handle is
thus readily breakable and detachable from the bridge at the
junction.
[0010] To use the device, a surgeon grasps the handle of the
circumcision device and positions the ring over the glans. The
foreskin is pulled distally over the ring, followed by the tying of
a ligature around the foreskin so as to compress the foreskin into
the groove of the ring. Excess foreskin distal to the ligature and
adjacent to the anterior end of the ring is trimmed off with
scissors or a scalpel. Finally, the handle is broken off and
detached from the bridge, leaving the bridge connected to the ring
and the flange. The glans now partially protrudes from the anterior
end so that its tip is in contact with the inner surface of the
bridge. The bridge therefore acts as an obstruction to the glans,
thereby limiting its protrusion from anterior end. Protrusion is
sufficiently limited so that after 3-8 days, the ring and attached
bridge are allowed to fall off the penis once the foreskin under
the ligature dies. As described above in other prior art devices,
the device of Smith requires the foreskin to be excised when the
device is used. In addition, the nature of the mechanism of Smith
may make it impractical for large scale use, possibly causing
reluctance among males to undergo the procedure of
circumcision.
[0011] Other patents and patent applications for methods and
devices for performing a circumcision include Chinese (CN) Patent
Application Publication No. 101327144A, Chinese (CN) Patent No.
2048737 and U.S. Pat. Nos. 2,272,072, 2,561,176 and 5,649,933.
SUMMARY OF THE PRESENT DISCLOSED TECHNIQUE
[0012] It is an object of the disclosed technique to provide a
novel method and system for circumcision a penis bloodlessly and
painlessly without requiring the use of sutures or bandages which
overcomes the disadvantages of the prior art. In accordance with
the disclosed technique, there is thus provided a system for
effecting ischemic necrosis in a foreskin of a penis. The system
includes a rigid ring, at least one elastic ring and at least one
circumferential groove. The rigid ring includes an inner surface,
the inner surface including an inner diameter, and an outer
surface, the outer surface including an outer diameter. The elastic
ring is configured to substantially fit around a surface of the
rigid ring. The circumferential groove is located on a surface of
at least one of the rigid ring and the elastic ring. The inner
diameter of the rigid ring is at least slightly larger than a
diameter of a shaft of the penis and a diameter of the elastic ring
in a relaxed state is at least substantially equal to the diameter
of the shaft of the penis. The rigid ring is placed around a first
surface of the foreskin and the elastic ring is placed around a
second surface of the foreskin, with the foreskin being placed
within the circumferential groove. The rigid ring and the elastic
ring thereby compress the foreskin in the circumferential groove
with a compression force, wherein the compression force is
sufficient to effect ischemic necrosis in the foreskin.
[0013] According to another aspect of the disclosed technique,
there is thus provided a system for effecting ischemic necrosis in
a foreskin of a penis, including a semi-rigid ring, at least one
elastic ring and at least one circumferential groove. The
semi-rigid ring includes an inner surface, the inner surface
including an inner diameter, and an outer surface, the outer
surface including an outer diameter. The elastic ring is configured
to substantially fit around a surface of the semi-rigid ring. The
circumferential groove is located on a surface of at least one of
the semi-rigid ring and the elastic ring. The inner diameter of the
semi-rigid ring in a relaxed state is at least slightly larger than
a diameter of a shaft of the penis and a diameter of the elastic
ring in a relaxed state is at least substantially equal to the
diameter of the shaft of the penis. The semi-rigid ring is placed
around a first surface of the foreskin, the elastic ring is placed
around a second surface of the foreskin and the foreskin is placed
within the circumferential groove. The semi-rigid ring and the
elastic ring thereby compress the foreskin in the circumferential
groove with a compression force, wherein the compression force is
sufficient to effect ischemic necrosis in the foreskin.
[0014] According to a further aspect of the disclosed technique,
there is thus provided a holding system for deploying an elastic
ring around a rigid ring. The holding system is hollow and includes
at least three flanges, each one of the three flanges being
substantially located around a circumference of the holding system.
The holding system has a first convex polygonal shape and when the
elastic ring is stretched around the three flanges, it forms a
second polygon shape. The rigid ring includes an inner rigid ring
surface and an outer rigid ring surface. The inner rigid ring
surface includes an inner rigid ring diameter and the outer rigid
ring surface includes an outer rigid ring diameter. The rigid ring
is placed around a glans of a penis, between the glans and a
foreskin of the penis.
[0015] According to another aspect of the disclosed technique,
there is thus provided a system for removing foreskin tissue, the
foreskin tissue being compressed between at least one elastic ring
and a rigid ring. The foreskin tissue is necrotic above the elastic
ring. The system includes a closed loop suture string, the closed
loop suture string including a roughened section located along a
portion of the closed loop suture string. A diameter of the closed
loop suture string is at least slightly larger than an outer
diameter of the rigid ring.
[0016] According to a further aspect of the disclosed technique,
there is thus provided a system for removing foreskin tissue, the
foreskin tissue being compressed between at least one inner ring
and at least one outer ring, the foreskin tissue extending above
and below the outer ring. The system includes at least two
elements, a connector and at least one cutter. Each one of the two
elements includes an inner surface and an outer surface. The
connector is coupled with the two elements and the cutter is
coupled with the inner surface of at least one of the two elements.
The connector is for coupling the two elements. The connector is
configured to position the two elements around the least one inner
ring and the foreskin tissue. When the two elements are positioned
around the inner ring and the foreskin tissue, the cutter is
positioned above the outer ring, substantially touching the
foreskin tissue above the outer ring.
[0017] According to another aspect of disclosed technique, there is
thus provided a system for tracking a circumcision device, the
circumcision device including at least two elements. The system
includes a respective unique identification for each one of the at
least two elements an identification entry device and a processor.
Each respective unique identification is coupled with a respective
one of the two elements and the processor is coupled with the
identification entry device. The identification entry device is for
entering the respective unique identification in the processor. The
processor authenticates the two elements before the circumcision
device is used on an individual.
[0018] According to a further aspect of the disclosed technique,
there is thus provided a method for circumcising a foreskin of a
penis. The method includes the procedures of positioning a ring
element around a first surface of the foreskin, positioning at
least one elastic ring around a second surface of the foreskin,
thereby compressing the foreskin with a compression force and
removing the foreskin once the foreskin is necrotic. The
compression force is sufficient to effect ischemic necrosis in the
foreskin and the compression force is applied until the foreskin is
necrotic.
[0019] According to another aspect of the disclosed technique,
there is thus provided a method for circumcising a foreskin of a
penis. The method includes the procedures of positioning at least
one inner ring around an inner surface of the foreskin, positioning
at least one outer ring around an outer surface of the foreskin,
thereby compressing the foreskin between the inner ring and the
outer ring with a compression force and removing the foreskin once
the foreskin is necrotic. The compression force is sufficient to
effect ischemic necrosis in the foreskin and the compression force
is applied until the foreskin is necrotic.
[0020] According to a further aspect of the disclosed technique,
there is thus provided a method for tracking a circumcision device,
the circumcision device including at least two elements. The method
includes the procedures of coupling a respective unique
identification to each one of the at least two elements, entering
the respective unique identification a first time into a processor
and entering the respective unique identification a second time
into the processor. The first time is to authenticate each one of
the two elements before each one of the two elements is used on an
individual and the second time is after each one of the two
elements is removed from the individual.
[0021] According to another aspect of the disclosed technique,
there is thus provided a system effecting a full degeneration of a
skin tissue. The system includes a first, generally cylindrical,
hollow element and a second, preformed elastic element sized to fit
on an outside of the cylinder in an expanded condition. The first
hollow element has a minimal inner diameter sized to fit around a
human penis in an erected state and having a minimal outer diameter
small enough to allow folding of a human penis foreskin thereon.
The preformed elastic element is sized and shaped and has an
elastic coefficient suitable to apply a pressure of between 0.5 and
20 atmospheres, to tissue positioned between the elastic element
and the first hollow element. The pressure enables a painless
ischemic necrosis until a full degeneration of the tissue.
[0022] According to a further aspect of the disclosed technique,
there is thus provided a method of imposing full ischemic
degeneration to a foreskin portion. The method includes the
procedures of providing a circumcision clamp system, deploying the
circumcision clamp and removing the circumcision clamp over 72
hours after deployment. The circumcision clamp system includes an
inner ring configured to press a first surface of a skin tissue and
an outer ring clamp member configured to press a second surface
opposing the first surface of the skin tissue. The foreskin portion
in-between the inner and outer rings is compressed in a continuous
local compression pressure between 0.5 to 15 atmospheres.
[0023] According to another aspect of the disclosed technique,
there is thus provided a method for performing a non-surgical
cosmetic procedure to remove a dead tissue portion attached to a
foreskin. The method includes the procedures of providing a
circular clamping device to circumferentially clamp the foreskin,
providing a cutting device to anchor around the distal surface of
the clamping device and moving the cutting device with respect to
the clamping device, thereby dissecting the dead tissue portion
from foreskin. The clamping device includes a distal surface having
a first pattern and located above the dead tissue portion. The
cutting device includes a surface having a second pattern mating
the first pattern of the clamping device distal surface and at
least one blade projected between the mating patterns.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The disclosed technique will be understood and appreciated
more fully from the following detailed description taken in
conjunction with the drawings in which:
[0025] FIG. 1 is a schematic illustration of a bloodless
circumcision device, constructed and operative in accordance with
an embodiment of the disclosed technique;
[0026] FIGS. 2A-2E are schematic illustrations showing the method
of use of the circumcision device of FIG. 1, constructed and
operative in accordance with another embodiment of the disclosed
technique;
[0027] FIG. 3 is a schematic illustration of another bloodless
circumcision device, for accommodating a plurality of penis sizes,
constructed and operative in accordance with a further embodiment
of the disclosed technique;
[0028] FIG. 4 is a schematic illustration of a further bloodless
circumcision device, for accommodating a plurality of penis sizes,
constructed and operative in accordance with another embodiment of
the disclosed technique;
[0029] FIG. 5 is a schematic illustration showing different types
of circumferential grooves, constructed and operative in accordance
with a further embodiment of the disclosed technique;
[0030] FIG. 6 is a schematic illustration showing different types
of capturing rings, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0031] FIGS. 7A-7H are schematic illustrations showing different
shapes of capturing rings, constructed and operative in accordance
with a further embodiment of the disclosed technique;
[0032] FIGS. 8A-8B are schematic illustrations showing different
types of introducer shapes, constructed and operative in accordance
with another embodiment of the disclosed technique;
[0033] FIGS. 9A-9B are schematic illustrations showing another
bloodless circumcision device, constructed and operative in
accordance with a further embodiment of the disclosed
technique;
[0034] FIGS. 9C-9D are schematic illustrations showing the
capturing ring of FIGS. 9A-9B, constructed and operative in
accordance with another embodiment of the disclosed technique;
[0035] FIGS. 10A-10B are schematic illustrations showing a
capturing ring including a groove on its inner side, constructed
and operative in accordance with a further embodiment of the
disclosed technique;
[0036] FIGS. 10C-10D are schematic illustrations showing another
capturing ring including an embossed section on its inner side,
constructed and operative in accordance with another embodiment of
the disclosed technique;
[0037] FIG. 11 is a schematic illustration of a cross section of
the inner ring of FIG. 1, constructed and operative in accordance
with a further embodiment of the disclosed technique;
[0038] FIG. 12 is a schematic illustration of a further capturing
ring for foreskin disposal, constructed and operative in accordance
with another embodiment of the disclosed technique;
[0039] FIGS. 13A-13C are schematic illustrations of another
bloodless circumcision device, constructed and operative in
accordance with a further embodiment of the disclosed
technique;
[0040] FIGS. 14A-14E are schematic illustrations of different inner
ring shapes and configurations for use with a bloodless
circumcision device, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0041] FIGS. 15A-15D are schematic illustrations showing different
views of a foreskin cutter, constructed and operative in accordance
with a further embodiment of the disclosed technique;
[0042] FIGS. 16A-16D are schematic illustrations showing different
views of another foreskin cutter, constructed and operative in
accordance with another embodiment of the disclosed technique;
[0043] FIGS. 17A-17B are schematic illustrations showing a further
foreskin cutter, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0044] FIGS. 18A-18D are schematic illustrations showing a
capturing ring deployment system, constructed and operative in
accordance with another embodiment of the disclosed technique;
[0045] FIGS. 19A-19K are schematic illustrations showing the method
of use of the capturing ring deployment system of FIGS. 18A-18D
with a bloodless circumcision device, constructed and operative in
accordance with a further embodiment of the disclosed
technique;
[0046] FIG. 20 is a schematic illustration of size selector for
determining the appropriate size of a bloodless circumcision device
to be used on an individual, constructed and operative in
accordance with another embodiment of the disclosed technique;
[0047] FIGS. 21A-21G are schematic illustrations of flexible inner
ring shapes and configurations for use with a bloodless
circumcision device, constructed and operative in accordance with a
further embodiment of the disclosed technique; and
[0048] FIGS. 22A-22G are schematic illustrations of other inner
ring shapes and configurations for use with a bloodless
circumcision device, constructed and operative in accordance with a
further embodiment of the disclosed technique.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0049] The disclosed technique overcomes the disadvantages of the
prior art by providing a bloodless circumcision device, including
an inner ring and a capturing ring, which are coupled together
around the foreskin of a penis for causing controlled ischemic
necrosis of the foreskin until the foreskin tissue degenerates,
dehydrates or both. The bloodless circumcision device may also
include a capturing ring deployment device, a removal device and
optionally an introducer. The bloodless circumcision device is
substantially painless and bloodless, allowing for a safe and
precise detachment of the foreskin of the penis of a male
individual once the foreskin has fully degenerated, dehydrated or
both. It is noted that any references to individuals in the
description of the disclosed technique refer to male individuals
(i.e., infants, children, adolescents and adults). The inner ring,
capturing ring or both may include a circumferential groove, or at
least one recess, suited to tightly receive a portion of the
foreskin. The capturing ring deployment device may be used to
position the capturing ring on the inner ring accurately, thereby
enabling the foreskin to be circumcised at a precise location. The
capturing ring deployment device is used to hold the capturing ring
in a stretched position, or a stretched form, before placement on
the inner ring. The removal device is used to remove at least one
of the capturing ring, the inner ring and a dead foreskin. The
removal device can also prevent reuse of the bloodless circumcision
device by rendering the bloodless circumcision device unusable. The
introducer is a hollow elongated cylindrical element used to
optionally position the inner ring on the penis of an individual.
In some embodiments, the capturing ring can be an elastic ring,
such as a rubber O-ring. The capturing ring and the inner ring may
optionally have specific cross section shapes which increase the
effectiveness of skin tissue degeneration and skin tissue
self-detachment. The skin tissue of the foreskin is degenerated by
uniformly compressing the foreskin between the inner ring, which
may be rigid, semi-rigid, malleable, expandable, shrinkable or a
combination of the aforementioned, and the capturing ring, which
may be elastic. The compression of the foreskin eventually causes
full necrosis of the foreskin which may then self-detach or be
removed. The disclosed technique may be considered, fully or
partially, a cosmetic non-surgical operation that only comprises
the removal of dead tissue.
[0050] In some embodiments of the disclosed technique, the penis of
an individual is circumcised bloodlessly by first pulling the
foreskin of the penis down, away from the glans. The inner ring is
then placed around the glans, optionally using the introducer and
the foreskin is then pulled up over the inner ring. In other
embodiments of the disclosed technique, the opening of the foreskin
is stretched open and the inner ring is inserted through the
opening of the foreskin around the glans of the penis. The inner
ring is then maneuvered and positioned at a desired location around
the glans. The inner ring is thus positioned between the inner
surface of the foreskin and the glans of the penis. The capturing
ring is then placed over the foreskin, substantially tightly
fitting into the circumferential groove of the inner ring. The
capturing ring is thus positioned around the outer surface of the
foreskin. The capturing ring may be placed directly on the foreskin
which is over the inner ring or may be placed on the foreskin which
is over the inner ring with the aid of the capturing ring
deployment device, leaving the foreskin compressed between the
inner ring and the capturing ring. With the foreskin tightly
compressed such that no blood reaches the skin tissue in the
foreskin, controlled ischemic necrosis to the foreskin is caused.
After a time period, usually a few minutes to a few hours, the
cells in the skin tissue of the foreskin begin to die. Within a few
days, for example after 72 hours or between 5-7 days, the skin
tissue in the foreskin fully dehydrates and becomes hard and dry.
At this point, the removal device can be used for excising the dead
foreskin tissue from the live foreskin tissue still intact below
the capturing ring in a substantially painless and bloodless
manner. Alternatively, the foreskin either falls off along the
circumference of the capturing ring naturally, or can easily be
removed using any surgical or non-surgical cutting or peeling
device such as an ordinary pair of scissors, a scalpel or a
foreskin cutter, as described below, without any incision to live
skin tissue and without any need for suturing. Once the foreskin
has fallen off or has been removed, the inner ring can be removed
manually or with the aid of a cutting device or the removal device.
The shape and configuration of the inner ring and capturing ring
enable consistent circumcision results to be achieved. Once the
bloodless circumcision device has been removed from the individual,
further suturing or bandaging is not needed. Therefore, the
individual does not need any suturing or bandaging during or after
the process of circumcision using the disclosed technique. As shown
below, the disclosed technique does not necessitate highly skilled
personnel and can be easily taught to individuals involved in a
mass circumcision campaign.
[0051] As taught by the disclosed technique, the radial pressure
caused by the compression of the capturing ring on the inner ring
enables a painless and bloodless procedure for circumcision. The
radial pressure is substantially high enough to stop blood
circulation to the foreskin, thereby causing ischemic necrosis,
preventing blood flow to the nerves in the foreskin and preventing
dislodgment of the capturing ring from the inner ring during normal
activity of the individual. At the same time, the radial pressure
is not high enough to exert a crushing force on the foreskin which
may cause pain to the individual. As an example, the radial
pressure may vary between the ranges of 0.1-20 atmospheres. A
specific range of compressive pressures may be set in order to
allow for painless ischemic necrosis of the foreskin. For example,
the specific range may be from 0.1-20 atmospheres, 0.5-15
atmospheres, 1.5-10 atmospheres or any combination thereof having
higher, lower or intermediate values.
[0052] The disclosed technique also allows for cost effectiveness
in a mass circumcision campaign, as the entire process of applying
the bloodless circumcision device, removing the foreskin and
removing the device from an individual can be done in any
environment, even if not sterile and even without highly trained
personnel. The disclosed technique only requires a minimal amount
of training before use and application. The disclosed technique is
thus cost efficient as compared with the costs of alternative
methods for circumcision such as a typical mini-surgery. The
disclosed technique further enables a safe and simple circumcision
device. The dimensions of the capturing ring and the inner ring are
selected such that damage is not caused to the penis if the penis
becomes erect while the device is on an individual. In addition, no
strings need to be attached or coupled to the foreskin surrounding
the inner ring. Also, the circumcision device can be deployed and
removed without use of anesthesia, either local or general. The
circumcision device of the disclosed technique thus represents a
simple and safe circumcision device which is completely bloodless,
painless, does not require sutures, surgical cuts or incisions to
skin tissue at the time of deployment or removal, can be easily
removed without causing pain, or harm to the individual (even
without anesthetics) and can be scaled to be used in a mass
circumcision campaign.
[0053] It is noted that the term `necrosis` substantially refers to
tissue death, also known as gangrene. The term `ischemia` refers to
localized anemia (i.e., reduction in the number of red blood cells)
in a portion of the body due to an obstruction. The term `ischemic
necrosis` therefore refers to tissue death caused by an obstruction
which causes deprivation of the blood supply to the tissue.
Ischemic necrosis can also refer to the process of tissue death
caused by a continuous obstruction which causes deprivation of the
blood supply to the tissue. It is also noted that the term
`hemostasis` refers the stoppage of bleeding. It is furthermore
noted that the term `degeneration` in medical usage refers to the
deterioration of body tissue wherein the tissue changes from a
higher to a lower or less functionally active form. Degeneration
may also imply that the tissue undergoes an actual chemical change.
When tissue has fully degenerated, the tissue can be considered
dead or necrotic. During the process of degeneration, the tissue
rots and eventually becomes dry and hard when most, if not all
fluids in the tissue are absent.
[0054] In general, identical elements and components which appear
in more than one figure are labeled using identical numbers. The
dimensions of elements, components and features shown in the
figures are not necessarily shown to scale and may be drawn for the
purposes of clarity and convenience. Many of the figures presented
are presented as schematic illustrations for explanatory purposes,
and as such, certain elements and components may be substantially
simplified and not drawn to scale. The figures are not intended to
be production drawings.
[0055] Reference is now made to FIG. 1, which is a schematic
illustration of a bloodless circumcision device, generally
referenced 100, shown in a disassembled configuration, constructed
and operative in accordance with an embodiment of the disclosed
technique. Circumcision device 100 includes an introducer 102, an
inner ring 104 and a capturing ring 106. Introducer 102 is an
elongated hollow cylinder, suited to receive a penis. Introducer
102 is an optional element. The size of introducer 102 may be
modified to receive different penis sizes. Inner ring 104 is a
hollow cylinder, having a length smaller than that of introducer
102. Inner ring 104 may have a length, for example, of 2
centimeters. The inner diameter (not shown) of inner ring 104 is
greater than the outer diameter of introducer 102, such that inner
ring 104 may be fitted over introducer 102. Inner ring 104 includes
a circumferential groove 108 on its outer side (not shown). The
diameter of capturing ring 106 is such that it may tightly fit into
circumferential groove 108 of inner ring 104. The inner surface of
inner ring 104 (not shown) may be coated with, or made of a soft
material, such as synthetic fleece, polyurethane latex or a soft
silicone coating to ease placement of inner ring 104 over the penis
of an individual and to reduce any potential pain or friction to
the individual while inner ring 104 is properly positioned.
Capturing ring 106 may be constructed of an elastic material such
as rubber or silicone. Capturing ring 106 can also be manufactured
from an elastic, super elastic, spring-like or distensible
material, such as, but not limited to, silicon, polyurethane,
stainless steel, Nitinol or any combination of such materials.
Capturing ring 106 can further be manufactured from a shape memory
alloy. Introducer 102 and inner ring 104 are typically constructed
of a rigid material such as plastic. Introducer 102 and inner ring
104 can also be manufactured from a non-compressible, or minimally
compressible biocompatible plastic material, such as, but not
limited to, polycarbonate, silicon, silicone, polyether,
polyethylene, polyurethane and the like. In addition, introducer
102 and inner ring 104 can also be manufactured from a
biocompatible metal, such as, but not limited to, stainless steel.
Furthermore, introducer 102 and inner ring 104 may be manufactured
from a combination of a biocompatible plastic material and a
biocompatible metal. Introducer 102, inner ring 104 and capturing
ring 106 can be manufactured from biodegradable materials, such as
polylactic acid (also known as PLA), or combinations of
biodegradable materials, such as the polymers trimethylene
carbonate (TMC), L-polylactic acid (LPLA), D,L-polylactic acid
(DLPLA) and polyglycolic acid (PGA), which are commonly used in
human implants. By manufacturing introducer 102, inner ring 104 and
capturing ring 106 from biodegradable materials, any potential
environmental impact from the use and disposal of bloodless
circumcision device 100 can be minimized over time. It is noted
that whereas the described embodiments of the bloodless
circumcision device of the disclosed technique, including inner
ring 104 and capturing ring 106, are designed to be single use
devices to reduce the likelihood of cross infection, the elements
of the disclosed technique may be manufactured from materials which
can be recycled after use. In general, any surface on introducer
102 and inner ring 104 which comes in contact with the skin tissue
of the foreskin should be soft and resilient. Circumferential
groove 108 on the other hand, should be rigid and
non-resilient.
[0056] It is noted that the inner diameter of inner ring 104 is
equal to or larger than the diameter of the penis (not shown) over
which it is placed when the penis is erect, thereby leaving
sufficient space for penis erections without applying pressure on
the penis itself when bloodless circumcision device 100 is used on
the penis. For example, inner ring 104 may have a diameter which is
1 centimeter larger than the diameter of the shaft of the penis
over which inner ring 104 is placed when the penis is flaccid. As
another example, inner ring 104 may have a diameter which is the
same or larger than the diameter of the shaft of the penis over
which inner ring 104 is placed when the penis is erect. In another
embodiment of bloodless circumcision device 100, the inner diameter
of inner ring 104 as well as the inner diameter of capturing ring
106 may be smaller than the diameter of the glans penis over which
they are placed and are placed in front of the glans penis in this
case.
[0057] The diameter (not shown) of capturing ring 106, when not
stretched, is generally smaller than the diameter (not shown) of
the inner side (not shown) of inner ring 104. For example, the
diameter of capturing ring 106 may be smaller than the diameter of
the inner side of inner ring 104, or the diameter of
circumferential groove 108, by 1-10 millimeters (herein abbreviated
mm). In addition, the diameter of capturing ring 106, when not
stretched, is generally larger than the widest point of the penis
shaft (not shown) on which it is placed by at least 3 mm. In
another embodiment, the diameter of capturing ring 106, when not
stretched, is substantially equal to or larger than the diameter of
the shaft of the penis when the penis is flaccid, measured from the
sulcus at the base of the glans penis. The smaller diameter of
capturing ring 106 as compared to the diameter of inner ring 104 is
what produces pressure on the foreskin (not shown) in an inward
radial direction, eventually leading to necrosis of the foreskin,
as described below in FIGS. 2A-2E. The relative diameter of
capturing ring 106 to inner ring 104, the penis shaft and the glans
of the penis (both not shown) is significant for safety reasons,
since if capturing ring 106 slips off inner ring 104, it will not
apply pressure to the penis shaft or the glans of the penis, even
if the penis is erect.
[0058] In general, capturing ring 106 is elastic in nature and when
placed over a foreskin on inner ring 104, generates an inward
radial pressure that is higher than the blood pressure in the blood
vessels in the foreskin. As mentioned above, this inward radial
pressure leads to necrosis of the foreskin. Also, as mentioned
above, this inward radial pressure is not so high as to crush the
blood vessels in the foreskin which may lead to a sensation of pain
in the foreskin and to the individual using circumcision device
100. In addition, the pressure exerted by capturing ring 106 on
inner ring 104 should be high enough to prevent the dislodgement of
capturing ring 106 from circumferential groove 108, or the
displacement of inner ring 104 during normal activity of the
individual, including penis erections of the individual. In
general, the minimal inward radial pressure required to cause
ischemic necrosis of the foreskin can substantially be between 0.05
and 0.13 atmospheres, depending on the thickness, shape and size of
an individual's foreskin as well as on anatomical and physiological
parameters of the individual. Therefore the inward radial pressure
of capturing ring 106 on the foreskin should be at least 0.05
atmospheres (which is approximately equal to 40 millimeters of
mercury (mm Hg)). In general, the minimal inward radial pressure
required to prevent capturing ring 106 from possibly dislodging
from circumferential groove 108, for example during erections of
the penis, can substantially be between 0.1 and 0.5 atmospheres, or
possibly higher, such as at least 1 atmosphere or at least 2
atmospheres, again depending on anatomical and physiological
parameters of the individual, such as the thickness, shape and size
of the individual's foreskin. Alternatively therefore, the inward
radial pressure of capturing ring 106 on the foreskin should be at
least 0.1 atmospheres or greater, which will generally prevent the
dislodgement of capturing ring 106 from circumferential groove 108,
for example during erections of the penis. In general, a minimal
inward radial pressure of approximately 3 to 20 atmospheres or
more, may crush the blood vessels in the foreskin, thereby causing
sensations of pain in the foreskin, irregardless of psychological
aspects of pain relating to the individual. Therefore, the inward
radial pressure of capturing ring 106 on the foreskin should be no
more than 20 atmospheres to avoid inducing pain in the individual.
In summary, the inward radial pressure, or compression force, of
capturing ring 106 on the foreskin should be minimally 0.1
atmospheres and maximally 20 atmospheres, depending on anatomical
and psychological parameters of the individual. The ranges of
possible compression forces for the capturing ring of the disclosed
technique on the foreskin is a matter of design choice and could
range, for example, from 0.1-20 atmospheres, 0.5-10 atmospheres,
1-5 atmospheres or 1.5-3 atmospheres.
[0059] Given the range of inward radial pressures, the elasticity
of capturing ring 106 should be selected to result in such a
pressure range when it is stretched by a few millimeters
(representing, for example, an increase in the length of capturing
ring 106 by between 2.5%-20% of its length when not stretched).
Thus depending on the material from which capturing ring 106 is
constructed as well as its thickness, a small increase in its
diameter when stretched may generate the above mentioned pressures.
For example, such pressures may be achieved by increasing the
diameter of capturing ring 106 when stretched from 0.1-5
millimeters dependent on the pressure considerations relating to
capturing ring 106 mentioned above. Furthermore, if capturing ring
106 is made from a shape memory alloy, then capturing ring 106 may
have two states, a larger diameter state when the temperature of
capturing ring 106 is relatively cool and a smaller diameter state
when the temperature of capturing ring 106 is relatively hot. In
the larger diameter state, capturing ring 106 may have a diameter
that is larger than the diameter of the penis. When capturing ring
106 is placed around a penis, it is placed when it is relatively
cool. As body heat of the individual in the area of the penis heats
up capturing ring 106, the diameter of capturing ring 106 shrinks
to its diameter in the smaller diameter state. The diameter of
capturing ring 106 when capturing ring 106 is in the smaller
diameter state should be selected taking into consideration the
above stated pressure requirements. In addition, the material,
thickness and diameter of capturing ring 106 needs to be selected
and determined while taking into consideration the above stated
pressure requirements. One example of such a capturing ring would
be a capturing ring made from EPDM rubber, having a thickness
ranging from 1.5-3.5 mm, with a diameter ranging from 20-40 mm. The
pressure of such a capturing ring on an inner ring can be between
0.5-20 atmospheres which is at least one order of magnitude higher
than the pressure necessary for inducing necrosis of the foreskin.
Table 1 below shows a few examples of possible dimensions for inner
ring 104 and capturing ring 106 as well as the inward radial
pressure exerted on a foreskin when compressed by capturing ring
106 and inner ring 104.
TABLE-US-00001 TABLE 1 Example Capturing Ring and Inner Ring
Dimensions and Inward Radial Pressure Capturing Ring Capturing Ring
Inner Ring Outer Inner Diameter (cm) Thickness (cm) Diameter (cm)
Pressure (atm) 2.347 0.266 2.76 0.60 2.507 0.266 2.96 0.68 2.665
0.266 3.16 0.58 2.825 0.266 3.36 0.53 3.142 0.266 3.60 0.61
[0060] Reference is now made to FIGS. 2A-2E, which are schematic
illustrations showing the method of use of the bloodless
circumcision device of FIG. 1 on a penis, constructed and operative
in accordance with another embodiment of the disclosed technique.
FIGS. 2A-2E show the various steps of using the bloodless
circumcision device of FIG. 1, each step demonstrating how the
bloodless circumcision device is applied to the penis of an
individual to circumcise the individual. FIG. 2A is a schematic
illustration of a first step of the application of the bloodless
circumcision device of FIG. 1. FIG. 2B is a schematic illustration
of a second step of the application of the bloodless circumcision
device of FIG. 1. FIG. 2C is a schematic illustration of a third
step of the application of the bloodless circumcision device of
FIG. 1. FIG. 2D is a schematic illustration of a fourth step of the
application of the bloodless circumcision device of FIG. 1. And
FIG. 2E is a schematic illustration of a fifth step of the
application of the bloodless circumcision device of FIG. 1.
[0061] With reference to FIG. 2A, a penis 120 includes a glans 124
and a foreskin 122. In this first step, which is a preliminary step
before the bloodless circumcision device is applied to penis 120,
foreskin 122 is pulled down, away from glans 124, in a direction
indicated by an arrow 126. The pulling of foreskin 122 exposes
glans 124, which is normally covered by foreskin 122 in not erect
uncircumcised males. Optionally, in the first step shown in FIG.
2A, a line, such as a dotted line 132, can be marked, using for
example an erasable marker, on the shaft of the penis at the
location where the individual desires to have foreskin 122 removed.
If dotted line 132 is initially marked, then when foreskin 122 is
pulled down, dotted line 132 becomes covered by foreskin 122. In an
alternative to the first step, the opening (not shown) of foreskin
122 can be stretched open, either manually with the hands or with
an instrument. With reference to FIG. 2B, in the second step of the
application of the bloodless circumcision device, the various parts
of bloodless circumcision device 100 (FIG. 1) are placed over penis
120. First, capturing ring 106 (FIG. 1) is placed over the shaft of
penis 120 behind glans 124. Inner ring 104 (FIG. 1) is then placed
over introducer 102 (FIG. 1), which in turn is placed over glans
124 and positioned over the shaft of penis 120 below the corona
(not shown) of glans 124. The corona of glans 124 refers to the
area of penis 120 where the shaft of penis 120 and glans 124
intersect. A sulcus (not shown), which forms part of the corona of
glans 124, substantially separates the bottom of glans 124 from the
shaft of penis 120. It is noted, however, that introducer 102 may
be eliminated from the process if inner ring 104 is placed directly
below glans 124. Capturing ring 106 has a width shown by a line
130. As shown in FIG. 2B, dotted line 132 is not visible. In an
alternative to the second step, capturing ring 106 is placed over
the shaft of penis 120 behind glans 124 and inner ring 104 is
inserted vertically through the stretched open opening of foreskin
122, between foreskin 122 and glans 124. Inner ring 104 is then
placed horizontally around glans 124. With reference to FIG. 2C, in
the third step of the application of the bloodless circumcision
device, foreskin 122 is pulled over inner ring 104, including
circumferential groove 108 (FIG. 1), over glans 124. Foreskin 122
can be pulled in the direction indicated by an arrow 128 and
extended as much as needed, thereby lining up dotted line 132
(i.e., the marked circumcision line) with circumferential groove
108 of inner ring 104. In this manner, the amount of foreskin to be
removed can be adjusted according to the preference of an
individual. If dotted line 132 was marked on the shaft of the penis
in the first step, then when foreskin 122 is pulled up over inner
ring 104, dotted line 132 can be aligned with circumferential
groove 108 such that capturing ring 106 is placed on the shaft of
penis 120 over the location where the individual desires to have
foreskin 122 removed. In an alternative to the third step, inner
ring 104 is maneuvered around glans 124 and foreskin 122 is
adjusted such that inner ring 104 is placed at the desired location
of the circumcision. With reference to FIG. 2D, in the fourth step
of the application of the bloodless circumcision device, capturing
ring 106 is placed over foreskin 122 at dotted line 132 (i.e., over
inner ring 104), tightly fitting into circumferential groove 108 of
inner ring 104. In this position, capturing ring 106 and inner ring
104 tightly compresses foreskin 122 along circumferential groove
108. If dotted line 132 was marked on the shaft of the penis in the
first step, then when capturing ring 106 is placed in
circumferential groove 108 in the fourth step, dotted line 132 is
covered by capturing ring 106.
[0062] With reference to FIG. 2E, in the fifth step of the
application of the bloodless circumcision device, introducer 102 is
removed leaving inner ring 104 and capturing ring 106 on penis 120.
Optionally in the fifth step, a single piece of medical grade
adhesive tape 134 can be placed over the upper (i.e., the section
of foreskin 122 to be removed which is above capturing ring 106)
and lower (i.e., the section of foreskin 122 which is below
capturing ring 106) sections of foreskin 122, thereby covering a
portion of capturing ring 106, to prevent the individual from
moving or repositioning capturing ring 106. As shown, all an
individual sees once bloodless circumcision device 100 has been
applied is capturing ring 106, which may have a width of
approximately 1-4 millimeters, since inner ring 104 is covered by
foreskin 122. The application of bloodless circumcision device 100
thus enables the individual to carry on with his daily routine
without any interruption or disturbance caused by a device placed
around a portion of his penis. In addition, as mentioned above in
FIG. 1, since the diameter of inner ring 104 is equal to or larger
than the diameter of penis 120 when penis 120 is erect, the
application of bloodless circumcision device 100 minimizes the
likelihood of harm to the shaft of penis 120, pain an individual
using bloodless circumcision device 100 may feel if his penis
becomes erect while using the device, or both. According to the
disclosed technique, bloodless circumcision device 100 is left on
penis 120 until foreskin 122 dies. Typically, ischemic necrosis of
the foreskin will cause full foreskin death after a minimum of at
least 72 hours. Therefore bloodless circumcision device 100 is left
on penis 120 for a minimum of at least 72 hours.
[0063] It is also noted that according to the disclosed technique,
the foreskin of a penis can be circumcised bloodlessly without
requiring bandaging or suturing by compressing the foreskin between
two closed hollow surfaces, at least one of which is rigid, at a
compression force sufficient to cause ischemic necrosis of the
foreskin. According to the disclosed technique, the compression
force should be applied to the foreskin until the foreskin is dead
and dry, i.e., until the foreskin tissue is fully necrotic. At this
point, the dead and dry foreskin tissue can be removed, thereby
circumcising the penis. For example, according to the disclosed
technique, a prior art circumcision device can be used to apply a
compression force around the foreskin high enough to cause ischemic
necrosis. Such a prior art circumcision device is then left on the
penis, compressing the foreskin, until full necrosis is effected on
the foreskin, usually a few days after the device is placed on the
individual. The necrotic foreskin is then removed from the
individual before the device is removed from his penis.
[0064] In one embodiment of the disclosed technique capturing ring
106 is provided with a string, such as a suture string, for
removing the capturing ring (and subsequently inner ring 104 if
desired) before foreskin 122 falls off or is removed, if bloodless
circumcision device 100 has to be removed. The string forms a
closed loop around capturing ring 106. This is shown below in FIG.
7G. For example, if an incorrect size bloodless circumcision device
was placed on an individual, capturing ring 106 from the bloodless
circumcision device can be removed by simply pulling on the string.
Such an embodiment enables the individual using bloodless
circumcision device 100 to remove capturing ring 106 by themselves.
According to another embodiment of the disclosed technique,
capturing ring 106 can include at least one hole for inserting a
removal device for removing capturing ring 106 before foreskin 122
falls off or is removed. The removal device may be a string which
can be threaded through the at least one hole or a tool designed to
firmly couple with the at least one hole in capturing ring 106 for
removing capturing ring 106. Such an embodiment does not easily
enable the individual using bloodless circumcision device 100 to
remove capturing ring 106 by themselves and may require the
individual to go to a trained personnel to have capturing ring 106
removed. This embodiment enables the use of bloodless circumcision
device 100 to be more controlled and supervised by a trained
personnel as capturing ring 106 cannot be easily removed by the
individual using the device. An example of this is shown below in
FIG. 7H.
[0065] Capturing ring 106 and inner ring 104 tightly compress
foreskin 122 such that no blood reaches the foreskin tissue,
causing controlled ischemic necrosis to foreskin 122. As mentioned
above, the pressure exerted by capturing ring 106 on foreskin 122
is higher than the capillary pressure exerted by the blood vessels
in foreskin 122, thereby causing the controlled ischemic necrosis
of foreskin 122. The pressure exerted by capturing ring 106 on
foreskin 122 should be higher than approximately 0.05 atmospheres,
although a preliminary check may be used to determine a minimal
individual specific pressure to be exerted by capturing ring 106 on
foreskin 122 to cause ischemic necrosis of foreskin 122 of the
individual. In one embodiment of the disclosed technique,
substantially higher pressures can be used to firmly couple
capturing ring 106 to inner ring 104 or to circumferential groove
108 and to avoid undesired dislodgment of capturing ring 106 from
inner ring 104 or circumferential groove 108. For example, the
pressure exerted by capturing ring 106 may be greater than 0.5
atmospheres or greater than 1 atmosphere. In addition, capturing
ring 106 and inner ring 104 obstruct the blood supply to nerves
around the area of foreskin 122, thereby reducing or eliminating
any notion of pain or other sensations an individual may feel in
the area on penis 120 where the bloodless circumcision device is
placed. After a period usually lasting a few hours, the tissue in
the foreskin begin to degenerate due to necrosis and within a few
days is fully necrotic, degenerated and completely dry. The tissue
of the foreskin may fall off or self-detach naturally, or may be
removed using a foreskin cutter along the circumference of
capturing ring 106. Foreskin 122 may fall off, or be removed,
without an incision and no blood may be present during the entire
process. Due to necrosis, the tissue connecting foreskin 122 to
penis 120, also referred to as the circumcision line, heals
autonomously, thereby eliminating the need for sutures of the
tissue. In addition, since the tissue around the circumcision line
fully degenerates, the tissue does not undergo a healing process.
After foreskin 122 is separated from penis 120, inner ring 104 and
capturing ring 106 may be removed from penis 120, which is now
circumcised.
[0066] It is noted that in the case of a small diameter capturing
ring (not shown), small as compared to the size of a respective
inner ring (not shown), being placed on foreskin 122, the pressure
exerted by the capturing ring may be significantly higher then the
capillary pressure of the blood vessels in foreskin 122. At such a
pressure, the capturing ring may begin cutting through the necrotic
tissue of foreskin 122, possibly detaching foreskin 122 from penis
120 before foreskin 122 is fully necrotic and dry. This detachment
of the foreskin may occur after a day, a few days or even after a
number of hours after the placement of capturing ring 106 on
foreskin 122, depending on the pressure exerted by capturing ring
106 on foreskin 122. Early detachment of the foreskin before the
circumcision line has fully dehydrated may result in a skin
dehiscence at the circumcision line due to weak skin tissue. Such a
skin dehiscence may occur when the penis is under increased tension
such as during an erection. Such a skin dehiscence may result in
bleeding, infections and prolonged healing due to secondary
infections. In order to reinforce the skin tissue at the
circumcision line, according to one embodiment of the disclosed
technique, a biological glue (such as medical grade n-butyl
cyanoacrylate, medical grade octyl-cyanoacrylate or medical grade
flexible collodion, a combination of such glues or any other known
biocompatible glues, biologic glues, adhesion tapes, such as
Tegaderm, or adhesive tapes) is applied to the area of the
circumcision after the removal of the inner ring (not shown). Such
a biological "instant adhesive" glue may be applied to the area on
penis 120 where foreskin 122 fell off (herein referred to as the
circumcision area), to avoid any breakage or tearing of the skin
tissue around the circumcision area before complete healing of the
circumcision area occurs. In addition, right after capturing ring
106 is placed over foreskin 122 and inner ring 104, an adhesive
tape or biocompatible glue may be applied over capturing ring 106
and foreskin 122. The adhesive tape or biocompatible glue may be
treated with at least one of an anti-inflammatory substance,
antibiotics and an anesthetic substance. In the case of an adhesive
tape, it may be left until foreskin 122 is detached or it may be
changed periodically, such as once a day, once every other day and
so on. It is noted that in certain circumstances, inner ring 104
may be removed before foreskin 122 has become fully necrotic and
dry. At this stage, the inner surface (not shown) of the foreskin,
the surface of the corona of the glans of the penis (not show) or
both may adhere to inner ring 104, possibly causing pain or
bleeding to the individual if the inner ring is removed. This pain
or bleeding can be substantially prevented in such circumstances by
manufacturing the inner and outer surfaces of inner ring 104 to
have a smooth surface or by coating them with an anti-adhesive
material in order to prevent tissue adhesion of the penis to the
inner ring.
[0067] In the embodiment of the disclosed technique in which inner
ring 104 and capturing ring 106 are both smaller in diameter than
glans 124, the following alternative steps are followed for
applying bloodless circumcision device 100 to penis 120. In a first
step (not shown) inner ring 104 is pushed into the opening of
foreskin 122 over glans 124. In this step, inner ring 104 is pushed
far enough over glans 124 such that the urinary meatus (opening on
penis 120 from which urine is released--not shown) is exposed and
pressure is not exerted on the urethra (not shown). In addition,
inner ring 104 may include a soft backing on its inner side (not
shown), such as a soft silicone, thereby preventing the exertion of
pressure on glans 124 by the portion of inner ring 104 which is in
contact with glans 124. In a second step (not shown) foreskin 122
is pulled and stretched over inner ring 104. In a third step (not
shown), capturing ring 106 is pushed over foreskin 122 until it
fits securely over inner ring 104 and until it fits into
circumferential groove 108, such that a compression force is
exerted on foreskin 122 between inner ring 104 and capturing ring
106, stopping the blood supply to foreskin 122. After a period
usually lasting a few hours, the tissue in the foreskin dies due to
ischemic necrosis and within a few days falls off, or can be
removed, along the circumference of capturing ring 106. It is noted
that in this embodiment, the opening of inner ring 104 permits the
passage of urine until foreskin 122 detaches. In addition, in this
embodiment, since inner ring 104 is pushed up against the tip of
glans 124 but is not placed over the shaft of penis 120, the
likelihood of pain experienced by an individual using the device
during an erection is minimized.
[0068] It is noted that the inner surface of inner ring 104 may be
fabricated from a soft material such that contact of inner ring 104
with glans 124 will not exert significant pressure on glans 124
during erections and will not cause pain to penis 120 during
erections. Alternatively, inner ring 104 may be manufactured from a
flexible and minimally compressible material such as polyethylene,
polyurethane or silicone, as mentioned above. In such a case inner
ring 104 may be deformed in order to introduce it through the
opening of foreskin 122 (not shown). Such an inner ring is relevant
in the case when penis 120 suffers from phimosis. After being
deformed and placed around glans 124, due to its elastic nature
inner ring 104 will resume its circular shape and will be
positioned behind the corona of glans 124 under foreskin 122.
Afterwards, capturing ring 106 can be applied over foreskin 122,
with capturing ring 106 being placed in circumferential groove
108.
[0069] According to a further embodiment of the disclosed
technique, capturing ring 106 is manufactured from a material
having a distensibility coefficient as well as a specified
thickness such that the pressure exerted by capturing ring 106 is
sufficient to cause necrosis to foreskin 122 or is sufficient to
cut through the necrotic skin tissue (i.e., fully degenerated skin
tissue) of foreskin 122 but is not sufficient enough to cause
injury to the shaft of penis 120, for example in the case that
capturing ring 106 inadvertently slips off of inner ring 104.
According to the disclosed technique, the diameter of capturing
ring 106 when not stretched over foreskin 122 and inner ring 104
should be equal to or larger than the diameter of the shaft of
penis 120 (i.e., behind glans 124) when penis 120 is flaccid yet
smaller than the diameter of circumferential groove 108 of inner
ring 104. For example, the diameter of capturing ring 106 can be
between 1-10 millimeters smaller than the diameter of
circumferential groove 108 of inner ring 104.
[0070] It is noted that in another embodiment of the disclosed
technique, capturing ring 106 may be made of a solid and rigid
material, having a fixed diameter and inner ring 104 may be made of
an elastic or distensible material. In such an embodiment, the
following alternative steps are followed for applying bloodless
circumcision device 100 to penis 120. In a first step (not shown),
foreskin 122 is pulled down in the direction of arrow 126. This
step is similar to what is shown in FIG. 2A.
[0071] In a second step (not shown), capturing ring 106 is placed
on the shaft of penis 120, over foreskin 122 and inner ring 104 is
placed behind glans 124. Introducer 102 may be used to properly
position inner ring 104 over glans 124. This step is similar to
what is shown in FIG. 2B. In a third step (not shown), inner ring
104 is compressed around glans 124, thereby reducing its diameter,
while foreskin 122 is pulled up over inner ring 104. In a fourth
step (not shown), while inner ring 104 is still compressed and
after foreskin 122 has been pulled up, capturing ring 106 is placed
in line with circumferential groove 108, and the compression force
on inner ring 104 is released. As the compression force is
released, inner ring 104 expands to its initial diameter such that
a uniform radial force is exerted on foreskin 122 by inner ring 104
in the radial direction of capturing ring 106, thus stopping the
blood supply to foreskin 122. Foreskin 122 is thus compressed
against capturing ring 106, which is rigid and solid having a fixed
diameter. After a period usually lasting a few hours, the tissue in
the foreskin begins to die due to ischemic necrosis and within a
few days is completely necrotic. The tissue in the foreskin may
then fall off, or can easily be removed, along the circumference of
capturing ring 106. It is noted that in this embodiment, capturing
ring 106 may include a groove on its inner side (not shown), or a
circumferential embossed section on its inner side (also not
shown), on which inner ring 104 exerts an outward radial
compression force on foreskin 122. These types of capturing rings
are shown and described below in FIGS. 10A-10D.
[0072] It is also noted that inner ring 104 and capturing ring 106
may be covered by various ointments, creams, medications or other
ingredients to enhance the circumcision process of bloodless
circumcision device 100. For example, inner ring 104 and capturing
ring 106 may be covered by a medicated ointment to enhance faster
and smoother healing of the skin tissue when foreskin 122 detaches
from penis 120. Such ointments may be placed on inner ring 104 and
capturing ring 106 by dipping them in such ointments. As another
example, inner ring 104 and capturing ring 106 may be covered by an
ointment to prevent bacterial growth (such as Ambipor or
polydimethylsiloxane, also known as dimethicone), to reduce
inflammation, to cure an infection or to relieve or reduce pain at
the boundary line on penis 120 where foreskin 122 is detached. In
addition, inner ring 104 and capturing ring 106 may be fabricated
of a porous plastic material which can include the antibacterial
ointments mentioned above as well as alcohol. Also, inner ring 104
and capturing ring 106 may be fabricated from a porous plastic
material embedded with other compounds such as copper-based
antimicrobial fibers (for example, fibers sold by the company
Cupron). Silver and silane-based antimicrobial additives (for
example, silver-based products made by the company AcryMed) could
also be embedded or coated on inner ring 104 and capturing ring
106. Inner ring 104 and capturing ring 106 may be dipped in such
ointments before being applied to penis 120. Furthermore, inner
ring 104 and capturing ring 106 may be embedded or injected with
such ointments such that they release slowly when placed on penis
120. In addition, materials known to expedite the rate of necrosis,
the rate at which skin dies or the rate at which dead skin tissue
dries up can be embedded in inner ring 104 and capturing ring 106
by way of injection. In another embodiment, inner ring 104 and
capturing ring 106 can be coated with such materials. Such
materials can include silver, which is known to those skilled in
the art as an antiseptic. Also, inner ring 104, capturing ring 106
or both can be coated or embedded with alcohol which may aid in
drying up glans 124 and expediting the healing process of penis
120. As noted, inner ring 104 and capturing ring 106 can also be
made of plastics which possess drug-eluting compounds or
drug-eluting coatings. As such compounds and coatings are
eventually fully released from inner ring 104 and capturing ring
106, inner ring 104 and capturing ring 106 can also be made of
medical polymers having intrinsically antimicrobial side groups
which remain on the surface of inner ring 104 and capturing 106.
Such medical polymers are known to those skilled in the art (see
for example the referenced report of the 2008 Eighth World
Biomaterials Congress in Amsterdam, The Netherlands, at
http://www.omnexus.com/resources/editorials.aspx?id=22117).
Numerous grades of acetal copolymers including inorganic
antimicrobial additives are available, such as Anti-Crobe from the
company Ticona. Since these antimicrobial additives are distributed
evenly throughout these materials they are claimed to not abrade or
scratch off from the surface of such materials as do antimicrobial
coatings.
[0073] Furthermore, it is noted that inner ring 104 and capturing
ring 106 may be embedded with or covered with microelectronic
devices to enable fast healing and to reduce the likelihood of an
edema forming at the circumcision area once foreskin 122 falls off
or is removed. An example of such a device includes the ActiPatch,
sold by BioElectronics Corporation. Inner ring 104, capturing ring
106, or both may also be embedded with a transcutaneous electrical
nerve stimulator, also known as a TENS unit, for transmitting
electrical signals to the circumcision area for relieving pain
electronically. In addition, or as an alternative to the TENS unit,
a micro vibrator could be embedded in inner ring 104, capturing
ring 106 or both to provide the user of bloodless circumcision
device 100 (FIG. 1) with a pleasure mechanism while he cannot, or
is advised not to have sexual intercourse while waiting for his
foreskin to fall off and for his penis to heal. Inner ring 104,
capturing ring 106, or both may furthermore be coated with known
biodegradable polymers used in site-specific drug delivery devices
and methods. Inner ring 104, capturing ring 106, or both may also
be fabricated from such known biodegradable polymers used in
site-specific drug delivery devices and methods. Examples of such
are available from SurModics, such as their Eureka SOLO
biodegradable coating. In other embodiments of the disclosed
technique, inner ring 104, capturing ring 106, or both may be
embedded with known drug delivery systems for the controlled
release of therapeutic proteins to the circumcision area. For
example, when inner ring 104 is placed on penis 120, therapeutic
proteins to the circumcision area may be released by inner ring 104
according to a fully controlled drug release profile. An example of
such a system is the OctoDEX drug delivery system, sold by
OctoPlus. Bloodless circumcision device 100 may be fabricated in a
variety of colors or patterns.
[0074] It is also noted that bloodless circumcision device 100 may
include a unique identification, such as a barcode, a number, a
code in an embedded radio frequency identification (herein
abbreviated RFID) tag and the like on bloodless circumcision device
100. The unique identification may be used by an individual for
follow-up, verification and tracking purposes, either by phone or
over the Internet. For example, the unique identification may be
given to the individual by the personnel, such as the healthcare
personnel, deploying the bloodless circumcision device on the
individual. The unique identification may also be on the bloodless
circumcision device itself. The individual may then be able to call
a data center, or access a data center website, to report pain,
swelling or other side effects, on a periodic basis, resulting from
use of the bloodless circumcision device. Such a data center or
data center website can also function as a circumcision registry,
similar to immunization registries that are known in the art and
are commonly used. In some embodiments of the disclosed technique,
inner ring 104, capturing ring 106, or both may be embedded with an
RFID tag, a barcode, or both, for medical authentication,
verification and supply chain optimization or both. Authentication
can include determining if a medical device is legit (and not
counterfeit) as well as determining if a medical is still valid to
be used (or has expired). Such an addition to inner ring 104 and
capturing 106 can aid in reducing the likelihood of their reuse as
well as enabling improved monitoring of compliance to directives in
large scale circumcision campaigns. In this embodiment, inner ring
104, capturing ring 106, or both can be tracked and monitored from
the location where and time when they are fabricated to the
location where and time when they are used on an individual. Such
RFID tags are known and are available, for example, from the
company 3M. RFID tags may also be used in inner ring 104, capturing
ring 106, or both for commencing and stopping the release of
medication or drugs if inner ring 104, capturing ring 106, or both
are also embedded with a drug delivery system. RFID tags embedded
in inner ring 104, capturing ring 106 or both could further be used
to communicate with a drug delivery activation system (not shown),
whereby after deploying bloodless circumcision device 100 (FIG. 1)
on a user, the RFID tags are activated. The RFID tags then send a
signal to the drug delivery activation system to initiate the
diffusion of pain medications or anti-inflammatory compounds in
inner ring 104, capturing ring 106 or both. The drug delivery
activation system may execute a procedure of RFID tag recognition
before initiating the diffusion of medications or compounds. In
general, RFID tags and barcodes can be read by a scanner and
information, such as the device's identification number, the
manufacturer as well as the expiry date, can be sent from the
scanner (using known technologies such as Bluetooth, Wi-Fi or via a
cable) to a local computer, or uploaded directly to a location on
the Internet, where software can be used to track inventory,
process management or both. Such information could enable strict
monitoring in compliance in the use of bloodless circumcision
device 100 (FIG. 1), reduce the possibility of reuse of bloodless
circumcision device 100, thereby increasing the safety level in use
of the device on a large scale, and also reduce the likelihood of
using unsafe devices, such as counterfeit bloodless circumcision
devices.
[0075] The various steps of usage of the bloodless circumcision
device of FIG. 1 shown in FIGS. 2A-2E can be performed by
substantially any individual on himself or on another individual
after a short training session. The short training session may
include training on how to properly prepare the penis for
circumcision (e.g., washing and cleaning), how to choose the
correct size of bloodless circumcision device 100 (FIG. 1) for a
given penis size (also described below in FIG. 20), as well as how
to properly use and place bloodless circumcision device 100 on a
penis. As described, bloodless circumcision device 100 (FIG. 1)
does not require a sterile environment (such as an operating room),
anesthesia or sterile surgical instruments. In this regard,
personnel having undergone the short training session can use
bloodless circumcision device 100 to perform circumcisions quickly
and efficiently on substantially large amounts of males in any
location providing a generally clean environment. The bloodless
circumcision device of the disclosed technique is thus cost
efficient as compared to the cost of alternative methods for
circumcision such as the cost of a mini-surgery. The bloodless
circumcision device of the disclosed technique is also simple and
scalable as compared to the complexity of alternative methods for
circumcision such as a mini-surgery. The bloodless circumcision
device of the disclosed technique is also suitable for mass
circumcision campaigns due to its safety, scalability and
simplicity of use.
[0076] As mentioned in the background section, roughly two thirds
of those infected with HIV in the world live in Sub-Saharan Africa.
Application of the disclosed technique to circumcise males living
in Sub-Saharan Africa may potentially reduce the spread of HIV in
that continent. Various societies, villages and groups in
Sub-Saharan Africa may have cultural, religious or traditional
associations with specific colors. In addition in such societies,
villages and groups, specific colors may have specific or
particular cultural, religious or traditional significance.
According to the disclosed technique, bloodless circumcision device
100 is fabricated in a color that takes into account cultural,
religious or traditional significance, associations or both when
blood circumcision device 100 is to be used in a society, village
or group which attributes such significance or associations to
specific colors.
[0077] It is noted that bloodless circumcision device 100, when
being used on infants, can be packaged with other devices and
products relevant to infants, such as an umbilical cord clamp,
infant diapers, an infant pacifier, alcoholic swabs and the like.
Such a package can be marketed as a friendly and convenient pack
for parents. In addition, bloodless circumcision device 100 can
also be packaged with other accessories and devices used in the
context of its deployment, for example rubber gloves and a
disinfectant solution. Furthermore, bloodless circumcision device
100 may be packaged with medication, an anesthetic cream, such as
EMLA, or both, which can be spread in or around circumferential
groove 108. The medication or anesthetic cream may be packaged in a
sealed contained which is either manually breakable, controlled by
an RFID (i.e., the seal is opened from a signal sent or receive by
an RFID embedded in bloodless circumcision device 100) or both.
Bloodless circumcision device 100 may also be packaged with a grip
or handle to allow for easy removal of foreskin 122 after a few
days, once foreskin 122 has become necrotic and the skin tissue in
foreskin 122 has died.
[0078] Reference is now made to FIG. 3, which is a schematic
illustration of another bloodless circumcision device, for
accommodating a plurality of penis sizes, generally referenced 150,
constructed and operative in accordance with a further embodiment
of the disclosed technique. Bloodless circumcision device 150
represents a bloodless circumcision device similar to bloodless
circumcision device 100 (FIG. 1). Whereas bloodless circumcision
device 100 can be used for a single specified penis size, bloodless
circumcision device 150 can be used for a plurality of penis sizes.
Bloodless circumcision device 150 includes an introducer 152, a set
of inner rings 154 and a set of capturing rings 155. Set of inner
rings 154 includes a first size inner ring 160A, a second size
inner ring 160B and a third size inner ring 160C. It is noted that
the inner diameter of each inner ring in set of inner rings 154 is
substantially slightly larger than the diameter of the penis size
for which it is to be used for, leaving space for penis erections
while bloodless circumcision device 150 is on the penis without
applying pressure to the penis itself. Each inner ring in set of
inner rings 154 includes a respective circumferential groove on its
outer side. First size inner ring 160A includes a circumferential
groove 158A, second size inner ring 160B includes a circumferential
groove 158B and third size inner ring 160C includes a
circumferential groove 158C. Set of capturing rings 155 includes a
first size capturing ring 156A, a second size capturing ring 156B
and a third size capturing ring 156C. The diameter of a respective
capturing ring is such that it fits substantially tightly into a
respective circumferential groove of a respective inner ring. First
size capturing ring 156A fits substantially tightly into
circumferential groove 158A, second size capturing ring 156B fits
substantially tightly into circumferential groove 158B and third
size capturing ring 156C fits substantially tightly into
circumferential groove 158C. It is obvious to the worker skilled in
the art that additional inner rings and respective capturing rings
of various sizes can be included in bloodless circumcision device
150. Introducer 152 and each inner ring in set of inner rings 154
are typically constructed of a rigid material such as plastic,
whereas each capturing ring in set of capturing rings 155 may be
constructed of an elastic material such as rubber.
[0079] Introducer 152 is an elongated hollow cylinder, suited to
receive a penis. The diameter of introducer 152 is substantially
similar to the diameter of the largest inner ring in set of inner
rings 154, in this case, first size inner ring 160A. As such,
introducer 152 can be used to receive different penis sizes. Each
inner ring in set of inner rings 154 is a hollow cylinder, having a
shorter length than that of introducer 152. In one embodiment of
the disclosed technique, some of the inner rings in set of inner
rings 154 may have an inner diameter (not shown) greater than the
outer diameter of introducer 152, such that a particular inner ring
may be fitted over introducer 152. For example, first size inner
ring 160A has an inner diameter greater than the outer diameter of
introducer 152. Some of the inner rings in set of inner rings 154
may have an outer diameter (not shown) smaller than the inner
diameter (not shown) of introducer 152, such that a particular
inner ring must be fitted over a penis before introducer 152 is
placed over the penis. For example, third size inner ring 160C must
be fitted over the penis before introducer 152 is placed over the
penis. Bloodless circumcision device 150 is used as described above
in FIGS. 2A-2E except that it can accommodate a plurality of penis
sizes using a single introducer.
[0080] Reference is now made to FIG. 4, which is a schematic
illustration of a further bloodless circumcision device, for
accommodating a plurality of penis sizes, generally referenced 200,
constructed and operative in accordance with another embodiment of
the disclosed technique. Bloodless circumcision device 200
represents a bloodless circumcision device substantially similar in
design and use to bloodless circumcision device 150 (FIG. 3) and
includes an introducer 202, a set of inner rings 204, a set of
capturing rings 206 and a deployment ring 216. Set of inner rings
204 includes a first size inner ring 210A, a second size inner ring
210B and a third size inner ring 210C. It is noted that the inner
diameter of each inner ring in set of inner rings 204 is
substantially slightly larger than the diameter of the penis size
for which it is to be used for, leaving space for penis erections
while bloodless circumcision device 200 is on the penis without
applying pressure to the penis itself. Each inner ring in set of
inner rings 204 includes a respective circumferential groove on its
outer side as well as a respective selector tab also on its outer
side. Introducer 202 may also include a selector tab on its outer
side (not shown). First size inner ring 210A includes a
circumferential groove 208A and a selector tab 214A, second size
inner ring 210B includes a circumferential groove 208B and a
selector tab 214B and third size inner ring 210C includes a
circumferential groove 208C and a selector tab 214C. Set of
capturing rings 206 includes a first size capturing ring 212A, a
second size capturing ring 212B and a third size capturing ring
212C. The diameter of a respective capturing ring is such that it
fits substantially tightly into a respective circumferential groove
of a respective inner ring. First size capturing ring 212A fits
substantially tightly into circumferential groove 208A, second size
capturing ring 212B fits substantially tightly into circumferential
groove 208B and third size capturing ring 212C fits substantially
tightly into circumferential groove 208C. Deployment ring 216
includes an inner ring 218 and an outer ring 220. Introducer 202,
each inner ring in set of inner rings 204 and deployment ring 216
are typically constructed of a rigid material such as plastic,
whereas each capturing ring in set of capturing rings 206 may be
constructed of an elastic material such as rubber. Deployment ring
216 can be constructed from the same materials that inner ring 104
(FIG. 1) is constructed from, such as biodegradable materials.
Deployment ring 216 can also be referred to as a deployment element
and can be embodied having various shapes configured to place a
given capturing ring on a given inner ring. It is obvious to the
worker skilled in the art that additional inner rings and
respective capturing rings of various sizes can be included in
bloodless circumcision device 200.
[0081] Introducer 202 and set of inner rings 204 can be
manufactured as a single element. It is noted that in one
embodiment of the disclosed technique, the section where introducer
202 couples with first size inner ring 210A, the section where
first size inner ring 210A couples with second size inner ring 210B
and the section where second size inner ring 210B couples with
third size inner ring 210C can be made of a thinner amount of
material than the other sections of introducer 202 and set of inner
rings 204 to ease their respective detachment from one another. In
such an embodiment, selector tabs 214A-214C may not be required and
set of inner rings 204 can be fabricated without selector tabs
214A-214C (not shown). In another embodiment, set of rings 204 are
manufactured as a single element and introducer 202 is manufactured
as a single separate element. Introducer 202 is an elongated hollow
cylinder, suited to receive a penis. The diameter of introducer 202
is substantially similar to the diameter of the largest inner ring
in set of inner rings 204, in this case, first size inner ring
210A. As such, introducer 202 can be used to receive different
penis sizes. Each inner ring in set of inner rings 204 is a hollow
cylinder, having a shorter length than that of introducer 202. In
using bloodless circumcision device 200, the appropriate sized
inner ring in set of inner rings 204 is selected. Using the
respective selector tab, the appropriate inner ring is detached. If
the smallest size inner ring was not selected then the other sized
inner rings which are not needed can also be detached using their
respective selector tabs. Alternatively, inner rings having a size
smaller than the appropriately sized inner ring to be used are
first detached using the respective selector tab of the largest
sized inner ring which is smaller than the appropriately sized
inner ring to be used. Inner rings having a size larger than the
appropriately sized inner ring to be used can be left attached to
introducer 202 while introducer 202 is used to place the
appropriately sized inner ring on the penis. Once the appropriately
sized inner ring is placed on the penis, the other larger sized
inner rings as well as introducer 202 can be broken off using a
respective selector tab on the larger sized inner rings. Each inner
ring in set of inner rings 204, as well as introducer 202, may be
coupled together by a tamper proof seal such that each inner ring,
as well as introducer 202, can be detached easily without affecting
the functionality of another inner ring or of introducer 202. By
manufacturing bloodless circumcision device 200 such that at least
set of inner rings 204 are a single element, bloodless circumcision
device 200 is substantially a one-size-fits-all device. In this
respect, clinics or other locations set up to offer circumcision
services to uncircumcised males using the device of the disclosed
technique do not need to maintain multiple sizes of the device at a
given clinic.
[0082] Deployment ring 216 is be used to easily place a given
capturing ring in set of capturing rings 206 onto a respective one
of set of inner rings 204. A detailed embodiment of deployment ring
216 is shown below in FIGS. 18A-18D. Deployment ring 216 is a
substantially a hollow tube, having a shorter length than each one
of set of inner rings 204. Inner ring 218 and outer ring 220 are
substantially a single element made from a single piece of
material. The inner diameters of outer ring 220 and inner ring 218
are substantially the same, whereas the outer diameter of outer
ring 220 is slightly larger than the outer diameter of inner ring
218. Deployment ring 216 can be used to place a given capturing
ring onto a given inner ring by first placing the given capturing
ring around inner ring 218. Inner ring 218 is substantially large
enough that each one of set of capturing rings 206 can be placed
around inner ring 218, wherein smaller capturing rings may need to
be stretched in order to be placed around inner ring 218. Once a
given capturing ring has been placed on inner ring 218, deployment
ring 216 is placed over the shaft of a penis. As described above in
FIGS. 2A-2E, a given inner ring and introducer are then applied to
the penis. The given capturing ring is then removed from inner ring
218 and placed around the given inner ring, in the circumferential
groove of that inner ring. Deployment ring 216 may be removed from
the shaft of the penis immediately after one of the capturing rings
is placed in the circumferential groove on an inner ring if
deployment ring 216 has a diameter larger than the diameter of the
inner ring placed around the glans of the penis (not shown). If
deployment ring 216 has a diameter equal to or smaller than the
diameter of the inner ring placed around the glans of the penis,
then deployment ring 216 either remains on the shaft of the penis
until bloodless circumcision device 200 is removed a few days
later, or it is removed from the shaft of the penis after placement
of the capturing ring by being cut off or broken off. Deployment
ring 216 may include a tab (not shown) or a perforated section (not
shown) for easily breaking it off to facilitate its removal from
the shaft of the penis. Deployment ring 216 can substantially
reduce the likelihood that a capturing ring will get tangled in the
pubic hairs of an individual while the capturing ring is placed on
the shaft of the penis and then on a given inner ring. It is noted
that deployment ring 216 can be shaped as any kind of convex
polygon, such as a rectangle, square, pentagon or other convex
polygonal shapes. In such an embodiment, the diameter of an
inscribed circle in the convex polygon must be at least equal to
the diameter of the shaft of the penis (not shown). Bloodless
circumcision device 200 is used as described above in FIGS. 2A-2E
except that it can accommodate a plurality of penis sizes using a
single introducer.
[0083] Reference is now made to FIG. 5, which is a schematic
illustration showing different types of circumferential grooves,
generally referenced 250, constructed and operative in accordance
with a further embodiment of the disclosed technique. In FIG. 5,
cross sectional views of six inner rings are shown, each inner ring
having a different type of circumferential groove shape. A first
inner ring 252A includes a circumferential groove 254A. First inner
ring 252A and circumferential groove 254A are substantially similar
to inner ring 104 (FIG. 1) and circumferential groove 108 (FIG. 1).
Circumferential groove 254A is a standard groove having a
semi-circular or `U` shape. A second inner ring 252B includes a
circumferential groove 254B. Circumferential groove 254B includes a
circumferential embossed section 256, which can be referred to as a
ridge section. When a capturing ring (not shown) is placed in
circumferential groove 254B, the capturing ring exerts a
compression force on a foreskin (not shown) placed over second
inner ring 252B on either side of circumferential embossed section
256. Circumferential groove 254B may expedite the circumcision
process by applying a compression force to the foreskin at two
separate locations. In addition, if the foreskin to be circumcised
is irregular in its radial thickness, the application of a
compression force at two separate locations increases the
probability that the compression force will be exerted on areas of
the foreskin having a smaller thickness. A third inner ring 252C
includes a circumferential groove 254C. Circumferential groove 254C
includes an inner groove 258. When a capturing ring (not shown) is
placed in circumferential groove 254C, if the foreskin to be
circumcised is irregular in its radial thickness or substantially
thick, then inner groove 258 can accommodate any excess foreskin
(i.e., thick foreskin), such that a more uniform compression force
is exerted circumferentially on the foreskin. A fourth inner ring
252D includes a circumferential groove 254D. Circumferential groove
254D is a groove having a ridge-like shape, an edge-like shape or a
`V` shape.
[0084] A fifth inner ring 252E includes a circumferential groove
254E. Circumferential groove 254E includes a sharp ridge section
260, which can be referred to as a sharp edge section. The height
of sharp ridge section 260, as indicated by a line 264, may be for
example between 0.05 to 1.5 millimeters. When a capturing ring (not
shown) is placed in circumferential groove 254E, the capturing ring
exerts an increased compression force on a foreskin (not shown)
placed over fifth inner ring 252E, specifically on sharp ridge
section 260. The increased compression force on the foreskin as
well as the shape of sharp ridge section 260 may cause the foreskin
to detach from the penis (not shown) quicker, once the foreskin
becomes necrotic, than in the embodiments shown in first to fourth
inner rings 252A-252D, as sharp ridge section 260 gradually cuts
through the necrotic foreskin.
[0085] A sixth inner ring 252F includes at least two
circumferential grooves, a first circumferential groove 254F.sub.1
and a second circumferential groove 254F.sub.2. Additional
circumferential grooves (not shown) may be included in sixth inner
ring 252F, the number of circumferential grooves being a matter of
design choice. First circumferential groove 254F.sub.1 may be
referred to as a proximal circumferential groove, as it is located
closer to the shaft of the penis (not shown) than second
circumferential groove 254F.sub.2. Second circumferential groove
254F.sub.2 may be referred to as a distal circumferential groove,
as it is located farther from the shaft of the penis than first
circumferential groove 254F.sub.1. In one embodiment, second
circumferential groove 254F.sub.2 can include a sharp ridge section
262, as in fifth inner ring 252E and first circumferential groove
254F.sub.1 can have a standard groove having a semi-circular or `U`
shape as in first inner ring 252A. In such an embodiment, two
capturing rings are used to exert pressure on the foreskin (not
shown), a first capturing ring (not shown) over first
circumferential groove 254F.sub.1 and a second capturing ring (not
shown) over second circumferential groove 254F.sub.2. The second
capturing ring will exert a higher pressure on the foreskin than
the first capturing ring, resulting in necrosis of the foreskin at
sharp ridge section 262. Due to the shape of sharp ridge section
262, the necrotic foreskin may detach early as sharp ridge section
262 gradually cuts through the necrotic foreskin. The first
capturing ring may exert less pressure on the foreskin, not causing
necrosis to the foreskin and not cutting through the foreskin. The
first capturing ring may be used to hold the foreskin in place
against sixth inner ring 252F after the necrotic foreskin has been
detached at second circumferential groove 254F.sub.2 until the
circumcision area (not show) of the penis (not show) fully heals.
In another embodiment, the capturing ring placed in second
circumferential groove 254F.sub.2 may be significantly tighter than
the capturing ring placed in first circumferential groove
254F.sub.1, thereby resulting in a similar scenario as described
above. In a further embodiment, any one of circumferential grooves
254A-254E may be used in either one of the circumferential grooves
of sixth inner ring 252F.
[0086] In addition, as mentioned above, an inner ring and a
capturing ring of the disclosed technique may be covered, dipped
in, coated or embedded with an ointment, cream, ingredient or
medication for expediting the process of necrosis, preventing
bacterial growth, reducing pain and inflammation or for healing the
skin tissue at the location where the foreskin falls off or is
removed. Inner groove 258 may be filled with or injected with any
such ointment in liquid or gel form such that the ointment is in
contact with the skin tissue of the foreskin when the bloodless
circumcision device (not shown) of the disclosed technique is
applied to a penis. It is noted that any of the inner rings of the
disclosed technique, such as inner rings 104 (FIG. 1), 160A-160C
(FIGS. 3) and 210A-210C (FIG. 4) can be manufactured to have any of
the circumferential grooves shown in FIG. 5. In addition, other
circumferential groove configurations, such as combinations of the
circumferential grooves shown in FIG. 5, are possible and are a
matter of design choice.
[0087] Reference is now made to FIG. 6, which is a schematic
illustration showing different types of capturing rings, generally
referenced 280, constructed and operative in accordance with
another embodiment of the disclosed technique. A capturing ring 282
is shown in a perspective view in FIG. 6. A capturing ring 284
shows an orthogonal view of capturing ring 282. Capturing rings 282
and 284 are substantially the same as capturing rings 106,
156A-156C and 212A-212C and represent a single capturing ring of a
given axial thickness, shown by an arrow 290A. A group of capturing
rings 286 is shown in a perspective view in FIG. 6. A group of
capturing rings 288 shows an orthogonal view of group of capturing
rings 286. Each capturing ring in group of capturing rings 286 is
substantially similar. When each capturing ring in group of
capturing rings 288 is placed on top of each other, as shown in
FIG. 6, the combined axial thickness of group of capturing rings
288, shown by an arrow 290B, is substantially similar to the axial
thickness of capturing ring 284. As an example, group of capturing
rings 286 includes five capturing rings, which when combined
together substantially have the same thickness, size and diameter
as capturing ring 282. According to another embodiment of the
disclosed technique, a given size capturing ring may be
manufactured as a plurality of smaller thickness capturing rings,
for example as two rings, three rings, four rings, five rings, and
so on, so that the combined thickness of the plurality of smaller
thickness capturing rings matches the thickness of the given size
capturing ring. Manufacturing a given size capturing ring as a
plurality of smaller thickness capturing rings reduces concerns and
issues in manufacturing defects, since if a single capturing ring
in a group of capturing rings is defective, such as one of the
capturing rings in group of capturing rings 286, the other
capturing rings in the group of capturing rings can still be used.
If a given capturing ring, such as capturing ring 282, is
defective, then the capturing ring may not be used. In addition, by
reducing the thickness of a capturing ring, capturing rings may be
more easily positioned on the foreskin and an inner ring, since
smaller thicknesses make capturing rings, which are made of a
stretchable material, easier to stretch. Also, a plurality of
capturing rings enables the amount of pressure applied to the
foreskin to be controlled, as an increase in the number of
capturing rings placed around the foreskin and an inner ring will
increase the pressure exerted on the foreskin. It is noted that the
capturing rings of the disclosed technique can be manufactured
according to any of the types of capturing rings shown in FIG. 6
and described herein.
[0088] Reference is now made to FIGS. 7A-7H, which are schematic
illustrations showing different shapes of capturing rings,
constructed and operative in accordance with a further embodiment
of the disclosed technique. FIG. 7A shows a capturing ring shape,
generally referenced 300, and includes a side orthogonal view 302
of capturing ring 300 and a top orthogonal view 304 of capturing
ring 300. In this embodiment, capturing ring 300 is shaped as a
spring in its axial direction, including at least one coil. As
shown in side orthogonal view 302, capturing ring 300 includes
three coils. As shown in top orthogonal view 304, capturing ring
300 can be stretched radially in the directions of arrows 306,
thereby increasing its diameter in order to place capturing ring
300 in the circumferential groove (not shown) of an inner ring (not
shown). Once placed on an inner ring over the foreskin (not shown)
of an individual, due to the spring shape of capturing ring 300,
once the force in the direction of arrows 306 is released capturing
ring 300 returns to its original diameter, exerting a uniform
radial force on the foreskin in the direction of the inner ring.
FIG. 7B shows another capturing ring shape, generally referenced
310, shown in a cross sectional view. The cross sectional shape of
capturing ring 310 is substantially a gear 312, having a plurality
of outer teeth 314 and inner teeth 316. Between the plurality of
teeth (both inner and outer) is a plurality of spaces 318. When
capturing ring 310 is placed over the foreskin (not shown) of an
individual, inner teeth 316 and plurality of spaces 318 between
inner teeth 316 exert an inward radial compression force on the
foreskin. Due to the gear shape of capturing ring 310, capturing
ring 310 can accommodate foreskin having an irregular thickness
circumferentially, since inner teeth 316 will exert a greater force
on the foreskin than plurality of spaces 318. Outer teeth 314 are
optional and may be manufactured as part of capturing ring 310 to
simplify the manufacturing process of capturing ring 310. It is
noted that capturing ring 310 may be designed to have other cross
sectional shapes, such as a triangular cross sectional shape, a
star cross sectional shape and the like. Other cross sectional
shapes are possible as is obvious to one skilled in the art.
[0089] FIG. 7C shows a further capturing ring shape, generally
referenced 320, shown in a top orthogonal view. Capturing ring 320
includes a first section 322 and a second section 324. First
section 322 and second section 324 are separate elements and can be
detached from one another. Second section 324 includes a set of
arms 325. First section 322 includes a set of arm receivers (not
shown), for receiving set of arms 325 as well as an opening 326.
First section 322 is stretched open and placed around a foreskin
(not shown) and an inner ring (not shown). Second section 324 is
then stretched open and placed around first section 322 such that
set of arms 325 enter the set of arm receivers on first section
322, thereby rigidly coupling first section 322 with second section
324. It is obvious to one skilled in the art that other coupling
mechanisms could be used to couple first section 322 with second
section 324. FIG. 7D shows another capturing ring shape, generally
referenced 330, and includes a cross sectional view 332 of
capturing ring 330 and a top orthogonal view 334 of capturing ring
330. Capturing ring 330 is substantially shaped as a spring in its
circumferential direction, having a diameter shown by an arrow 335.
The diameter of the spring may be, for example, 1 to 3 millimeters.
The spring of capturing ring 330 is closed into a loop, giving
capturing ring 330 a toroidal shape, as shown in top orthogonal
view 334. Also, as shown in top orthogonal view 334, capturing ring
330 can be stretched radially in the directions of arrows 336,
thereby increasing its diameter in order to place capturing ring
330 in the circumferential groove (not shown) of an inner ring (not
shown). Once placed on an inner ring over the foreskin (not shown)
of an individual, due to the spring shape of capturing ring 330,
once the force in the direction of arrows 336 is released capturing
ring 330 returns to its original diameter, exerting a uniform
radial force on the foreskin in the direction of the inner
ring.
[0090] FIG. 7E shows a further capturing ring shape, generally
referenced 340, shown in a top orthogonal view. Capturing ring 340
is made from a single piece of material 342 and includes a set of
inner teeth 344 and a set of outer teeth 346. Capturing ring 340
can be opened up and placed around a foreskin (not shown) and an
inner ring (not shown). Once placed around the foreskin, capturing
ring 340 can be placed into a closed position (as shown in FIG. 7E)
by interlocking set of inner teeth 344 into set of outer teeth 346.
As shown, capturing ring 340 can be ratcheted by interlocking fewer
or more of set of inner teeth 344 into set of outer teeth 346. It
is obvious to one skilled in the art that other mechanisms, for
example a mechanism using snaps, can be used to place and hold
capturing ring 340 in a closed position. In addition, capturing
ring 340 enables the compression pressure it exerts on a foreskin
(not shown) and an inner ring (not shown) to be selected. For
example, capturing ring 340 may be embodied having a plurality of
teeth such that a plurality of compression pressures can be
selected. In such an embodiment, a pressure meter may be optionally
included with the disclosed technique which can be coupled with
capturing ring 340 to measure the compression pressure of capturing
ring 340 while it is placed around the foreskin and the inner ring.
FIG. 7F shows another capturing ring shape, generally referenced
350, shown in a top orthogonal view. Capturing ring 350 includes a
capturing ring 352 and leaflets 354A and 354B. Capturing ring 352
is substantially similar to capturing ring 106 (FIG. 1). Leaflets
354A and 354B can be constructed in a plurality of other shapes,
such as half rings (not shown) or lines (now shown). Leaflets 354A
and 354B simplify grasping capturing ring 352. Leaflets 354A and
354B are provided to facilitate the handling and placing of
capturing ring 352 on an inner ring (not shown). FIG. 7G shows a
further capturing ring shape, generally referenced 360, shown in a
top orthogonal view, mentioned above in the description of FIGS.
2A-2E. Capturing ring 360 includes a capturing ring 362 and a
suture string 364. Capturing ring 362 is substantially similar to
capturing ring 106 (FIG. 1). Suture string 364 forms a closed loop
around capturing ring 362 and can be used to remove capturing ring
362 once capturing ring 362 has been placed around a penis (not
shown) before the foreskin of the penis falls off or before it is
removed. FIG. 7H shows another capturing ring shape, generally
referenced 370, shown in a top orthogonal view, mentioned above in
the description of FIGS. 2A-2E. Capturing ring 370 includes a
capturing ring 372 and a plurality of holes 374A, 374B and 374C.
Capturing ring 372 is substantially similar to capturing ring 106
(FIG. 1). A removal device can be coupled with plurality of holes
374A, 374B and 374C for removing capturing ring 372 once capturing
ring 372 has been placed around a penis (not shown) before the
foreskin of the penis falls off or is removed. It is noted that
other arrangements of plurality of holes 374A, 374B and 374C are
possible and that the three holes shown in capturing ring 372 are
brought merely as an example. According to the disclosed technique,
the embodiment of capturing ring 372 should have at least one hole
(not shown) to which a removal device can be coupled with for
removing capturing ring 372.
[0091] Reference is now made to FIGS. 8A-8B, which are schematic
illustrations showing different types of introducer shapes,
constructed and operative in accordance with another embodiment of
the disclosed technique. FIG. 8A shows a first introducer shape,
generally referenced 380, shown in a longitudinal cross section
view. First introducer 380 includes an introducer 382. Introducer
382 has a circular shape and includes three separate sections, a
top section 388, an inner ring receiving section 390 and a tapered
section 392. Introducer 382 has an opening 394 at the end of
tapered section 392, into which the glans of a penis (not shown) is
inserted. Tapered section 392 may be made of an elastic or
distensible material to received the glans of a penis as the penis
is inserted into introducer 382. As the penis is inserted into
introducer 382, tapered section 392 may expand to accommodate the
penis. An inner diameter of introducer 382, shown by an arrow 396,
is uniform along top section 388 and inner ring receiving section
390. The outer diameter (not shown) of introducer 382 is larger in
top section 388 than in inner ring receiving section 390. Inner
ring receiving section 390 can receive an inner ring 384 having a
circumferential groove 386. FIG. 8B shows a second introducer
shape, generally referenced 410, shown in a longitudinal cross
section view. Second introducer 410 includes an introducer 412.
Introducer 412 has a circular shape and includes three separate
sections, a top section 418, an inner ring receiving section 420
and a conical section 422. Introducer 412 has an opening 424 at the
end of conical section 422, into which the glans of a penis (not
shown) is inserted. Conical section 422 may be made of an elastic
or distensible material to received the glans of a penis as the
penis is inserted into introducer 412. As the penis is inserted
into introducer 412, conical section 422 may expand to accommodate
the penis. An inner diameter of introducer 412, shown by an arrow
426, is uniform along top section 418 and inner ring receiving
section 420. The outer diameter (not shown) of introducer 412 is
larger in top section 418 than in inner ring receiving section 420.
Inner ring receiving section 420 can receive an inner ring 414
having a circumferential groove 416.
[0092] Using either first introducer 382 or second introducer 412,
inner ring 384 or inner ring 414 is placed on its respective
introducer in its respective inner ring receiving section. The
introducer is then placed over the opening of the foreskin near the
glans of a penis. As the introducer is moved down over the penis,
the opening of the foreskin (not shown) is dilated and the foreskin
is stretched around either tapered section 392 or conical section
422 as the introducer is moved towards the glans of the penis. This
is important if the penis on which the bloodless circumcision
device of the disclosed technique is to used suffers from phimosis,
a medical condition in which the foreskin of the penis is
constricted and cannot be drawn back. As the foreskin and its
opening are dilated and stretched by either tapered section 392 or
conical section 422, inner ring 384 or inner ring 414 is advanced
over the glans of the penis and the foreskin is pulled up over a
respective inner ring.
[0093] Reference is now made to FIGS. 9A and 9B, which are
schematic illustrations showing another bloodless circumcision
device, generally referenced 450, constructed and operative in
accordance with a further embodiment of the disclosed technique.
Bloodless circumcision device 450 includes an outer ring 452 and a
capturing ring 454. FIG. 9A shows bloodless circumcision device 450
from an orthogonal top view, whereas FIG. 9B shows bloodless
circumcision device 450 in a cross sectional view. Bloodless
circumcision device 450 operates in a manner similar to bloodless
circumcision device 100 except that the location and placement of
the inner ring and the capturing ring are reversed. Capturing ring
454 is substantially similar to capturing ring 106 (FIG. 1) and has
a circular cross section. Outer ring 452 operates in a similar yet
reversed manner to inner ring 104 (FIG. 1). Outer ring 452 includes
an inner circumferential groove 456. Inner circumferential groove
456 may be shaped like any of the circumferential groove shapes
shown above in FIG. 5.
[0094] In bloodless circumcision device 450, once the foreskin of a
penis (not shown) has been pulled down away from the glans of the
penis (not shown), capturing ring 454 is placed over the glans of
the penis. As shown in FIGS. 9A and 9B, the glans of the penis is
placed in the opening 458 of capturing ring 454. The diameter of
capturing ring 454 is such that it is slightly larger than the
diameter of the penis during an erection. The foreskin is then
pulled up over capturing ring 454. Outer ring 452 is then placed
over the foreskin such that capturing ring 454 is aligned with
inner circumferential groove 456. Capturing ring 454 and inner
circumferential groove 456 exert pressure on the foreskin, thereby
starting a process of ischemic necrosis of the foreskin, as the
outer diameter (not shown) of capturing ring 454 is substantially
the same as the inner diameter (not shown) of outer ring 452. It is
noted that capturing ring 454 may be made out of a soft,
distensible, resilient material and outer ring 452 may be made out
of a rigid material. In another embodiment of the disclosed
technique, capturing ring 454 may be made out of a rigid material
and outer ring 452 may be made out of a soft, distensible,
resilient material. In a further embodiment, capturing ring 454 may
have a cross section shaped like a triangle, as shown below in FIG.
9D. Other cross section shapes for capturing ring 454 are
possible.
[0095] Reference is now made to FIGS. 9C-9D, which are schematic
illustrations showing the capturing ring of FIGS. 9A-9B, generally
referenced 480, constructed and operative in accordance with
another embodiment of the disclosed technique. FIG. 9C shows
capturing ring 480 from an orthogonal top view, whereas FIG. 9D
shows capturing ring 480 in a cross sectional view. Capturing ring
480 includes a capturing ring 482 and a tapered circumference
section 484, which extends around the outer circumference of
capturing ring 482. Capturing ring 482 is substantially similar to
capturing ring 454 (FIGS. 9A and 9B). Tapered circumference section
484 has a cross section shaped like a triangle, yet other cross
sectional shapes of tapered circumference section 484 are possible.
When capturing ring 482 is placed over the glans of a penis (not
shown) and the foreskin of the penis (not shown) is pulled up over
capturing ring 482, tapered circumference section 484 exerts an
outward radial pressure on the foreskin. When an outer ring (not
shown) is then placed over the foreskin such that capturing ring
482 is aligned with the inner circumferential groove (not shown) of
the outer ring, then the outer ring and capturing ring 482 exert an
increased pressure on the foreskin, thereby causing ischemic
necrosis. Tapered circumference section 484 may increase the
pressure exerted on the foreskin, thereby quickening the process of
ischemic necrosis of the foreskin.
[0096] Reference is now made to FIGS. 10A-10B, which are schematic
illustrations showing a capturing ring including a groove on its
inner side, generally referenced 500, constructed and operative in
accordance with a further embodiment of the disclosed technique.
FIG. 10A shows capturing ring 500 in a cross sectional view and
FIG. 10B shows capturing ring 500 in a top orthogonal view.
Capturing ring 500 includes a capturing ring section 502 and an
inner groove 504. Capturing ring 500 can be used in the embodiment
of the bloodless circumcision device of the disclosed technique
described above in reference to FIGS. 2A-2E, where the capturing
ring may be made of a solid and rigid material, having a fixed
diameter and the inner ring may be made of an elastic or
distensible material. In such an embodiment, once the foreskin (not
shown) is placed between an elastic inner ring (not shown) and
capturing ring 500, inner groove 504 enables any excess foreskin
(i.e., thick foreskin) to be accommodated for, such that a more
uniform compression force is exerted circumferentially on the
foreskin.
[0097] Reference is now made to FIGS. 10C-10D which are schematic
illustrations showing another capturing ring including an embossed
section on its inner side, generally referenced 520, constructed
and operative in accordance with another embodiment of the
disclosed technique. FIG. 10C shows capturing ring 520 in a cross
sectional view and FIG. 10D shows capturing ring 520 in a top
orthogonal view. Capturing ring 520 includes a capturing ring
section 522 and an embossed section 524 on the inner side of
capturing ring 520. Embossed section 524 can be embodied having
other shapes, such as a tapered shape or a pointed shaped.
Capturing ring 520 can be used in the embodiment of the bloodless
circumcision device of the disclosed technique described above in
reference to FIGS. 2A-2E, where the capturing ring may be made of a
solid and rigid material, having a fixed diameter and the inner
ring may be made of an elastic or distensible material. In such an
embodiment, once the foreskin (not shown) is placed between an
elastic inner ring (not shown) and capturing ring 520, embossed
section 524 exerts an increased pressure on the foreskin thereby
expediting the process of ischemic necrosis.
[0098] Reference is now made to FIG. 11, which is a schematic
illustration of a cross section of the inner ring of FIG. 1,
generally referenced 550, constructed and operative in accordance
with a further embodiment of the disclosed technique. Inner ring
550 is substantially similar to inner rings 104 (FIG. 1), 160A-160C
(FIGS. 3) and 210A-210C (FIG. 4). Inner ring 550 includes a
circumferential groove 556 and a hollow 554 where the glans of a
penis (not shown) is placed. This thickness of the material from
which inner ring 550 is fabricated from is shown in a section 552.
An inner diameter 558 of inner ring 550 is shown via a
double-headed arrow. Inner diameter 558 represents the smallest
diameter from one side of circumferential groove 556 to the other
side of circumferential groove 556. In general, according to the
disclosed technique, the size of a given capturing ring (not shown)
to be used with a given inner ring like inner ring 550, such as in
the case where the bloodless circumcision device of the disclosed
technique is to be used for multiple penis sizes, is determined
based on the size of the inner diameter of the inner ring. In
general, the inner ring size is determined based on the diameter of
the shaft of the penis on which it will be used. For the bloodless
circumcision device of the disclosed technique to be used
effectively and safely, the outer diameter of a given capturing
ring (not shown) in a relaxed state should not be smaller than the
inner diameter of the inner ring to which it will be used with.
Otherwise, if the capturing ring slips off the inner ring onto the
penis, may exert too great a pressure on the foreskin or the shaft
of the penis, thereby causing pain to the individual.
[0099] Reference is now made to FIG. 12, which is a schematic
illustration of a further capturing ring for foreskin disposal,
generally referenced 570, constructed and operative in accordance
with another embodiment of the disclosed technique. Capturing ring
570 includes a capturing ring 572. Capturing ring 572 is
substantially similar to capturing rings 106 (FIG. 1), 156A-156C
(FIG. 3), 212A-212C (FIGS. 4) and 350 (FIG. 7F). Capturing ring 572
includes a plurality of flaps 574A, 574B and 574C. Plurality of
flaps 574A-574C are substantially similar to leaflets 354A and 354B
(FIG. 7F) of capturing ring 350. Plurality of flaps 574A-574C is
substantially fabricated from a soft, distensible, elastic
material. Using capturing ring 572, once the foreskin (not shown)
has died plurality of flaps 574A-574C can be folded up over the
foreskin. By then pulling up on plurality of flaps 574A-574C,
capturing ring 572 as well as the foreskin can be removed from the
penis (not shown) and disposed of, such as in a waste basket or
garbage pail, without the individual having to handle or touch the
foreskin which has undergone necrosis. Other shapes, forms and the
number of flaps on capturing ring 572 are possible as is obvious to
one skilled in the art. Plurality of flaps 574A-574C and capturing
ring 572 can be constructed from a single piece of material. In an
alternative embodiment, plurality of flaps 574A-574C and capturing
ring 572 can each be constructed from a single piece of material.
In such an embodiment plurality of flaps 574A-574C may be coupled
to one another by an elastic ring (not shown) have dimensions
similar to the dimensions of capturing ring 572. In this
embodiment, plurality of flaps 574A-574C may be coupled to
capturing ring 572 by placing the elastic ring under capturing ring
572 and folding plurality of flaps 574A-574C over capturing ring
572 and the foreskin. Squeezing on plurality of flaps 574A-574C and
pulling in an upward motion will remove capturing ring 572 and the
foreskin without the individual having to touch or handle the dead
necrotic skin of the foreskin.
[0100] Reference is now made to FIGS. 13A-13C, which are schematic
illustrations of another bloodless circumcision device, generally
referenced 600, constructed and operative in accordance with a
further embodiment of the disclosed technique. FIG. 13A shows a
first embodiment of bloodless circumcision device 600 for reducing
friction between the glans of the penis and a garment, like an
undergarment such as a diaper. Bloodless circumcision device 600
may be used on infants, children or adults for reducing potential
friction between the glans of the penis and an undergarment. FIG.
13A shows an inner ring 602 placed on the shaft of a penis (not
shown). Inner ring 602 includes a circumferential groove 604. The
individual's foreskin 606 (shown cross sectionally) has been pulled
up over inner ring 602 and a capturing ring 608 (shown cross
sectionally), having a circular cross section, has been placed over
foreskin 606. Capturing ring 608 is substantially aligned with
circumferential groove 604. As shown, when bloodless circumcision
device 600 is used, the glans 610 of the penis may be exposed.
Bloodless circumcision device 600 includes a protective element 612
(shown cross sectionally) for distancing glans 610 from an
undergarment 614. Undergarment 614 may be underwear, boxer shorts
or a diaper. As shown by arrows 616, protective element 612 rubs
against undergarment 614 instead of glans 610 rubbing against
undergarment 614. Protective element 612 is substantially round
having an upper opening 618 and a lower opening 620. Upper opening
618 distances glans 610 from undergarment 614 while enabling glans
610 to remain aerated. When used with infants, aerating glans 610
may expedite the drying up process of glans 610. Lower opening 620
may have a diameter which is slightly smaller than the diameter of
capturing ring 608 when capturing ring 608 is placed over foreskin
606 and inner ring 602. As such, when protective element 612 is
placed over glans 610 under capturing ring 608, the larger diameter
of capturing ring 608 may keep protective element 612 in place.
[0101] FIG. 13B shows a second embodiment of bloodless circumcision
device 600 for reducing friction between the glans of the penis and
an undergarment, such as a diaper. Similar elements to FIG. 13A are
numbered using identical numbers in FIG. 13B. In FIG. 13B,
capturing ring 608 (FIG. 13A) has been replaced by a capturing ring
622 (shown cross sectionally). Capturing ring 622 has an inner
groove 624. In FIG. 13B, protective element 612 (FIG. 13A) has been
replaced by a protective element 626 (shown cross sectionally).
Protective element 626 has a curved end 628. Curved end 628 is
substantially similar in size to inner groove 624. Curved end 628
can be inserted into inner groove 624. Inner groove 624 is used for
coupling protective element 626 to capturing ring 622, thereby
holding protective element 626 in place.
[0102] FIG. 13C shows a third embodiment of bloodless circumcision
device 600 for reducing friction between the glans of the penis and
an undergarment, such as a diaper. Similar elements to FIG. 13A are
numbered using identical numbers in FIG. 13C. In FIG. 13C, inner
ring 602 (FIG. 13A) has been replaced by an inner ring 630. Inner
ring 630 includes a first circumferential groove 632 and a second
circumferential groove 634. Capturing ring 608 is substantially
aligned with first circumferential groove 632. In FIG. 13C,
protective element 612 (FIG. 13A) has been replaced by a protective
element 636 (shown cross sectionally). Protective element 636 has a
curved end 638. Curved end 638 is substantially similar in size to
second circumferential groove 634. Curved end 638 can be inserted
into second circumferential groove 634. Second circumferential
groove 634 is used for exerting additional pressure on foreskin 606
and for coupling protective element 636 to inner ring 630, thereby
holding protective element 636 in place.
[0103] Protective elements 612, 626 and 636 may be made of a rigid
material, such as hard plastic, or a soft, distensible and elastic
material. In the case that protective elements 612, 626 and 636 are
made of a rigid material, each protective element may be made from
two identical parts which can be snapped together over bloodless
circumcision device 600. In the case that protective elements 612,
626 and 636 are made from a soft elastic material, lower opening
620 of each protective element may be stretched over bloodless
circumcision device 600.
[0104] It is also noted that besides the embodiments shown in FIGS.
13A, 13B and 13C, a cover may also be provided with the bloodless
circumcision device of the disclosed technique for covering the
inner ring, such as inner ring 608 (FIGS. 13A and 13C). Such a
covering (not shown) can reduce friction between the inner ring and
the areas of the body around the penis which may rub against the
inner ring during an individual's daily activities while wearing
the circumcision device of the disclosed technique.
[0105] Reference is now made to FIGS. 14A-14E, which are schematic
illustrations of different inner ring shapes and configurations for
use with a bloodless circumcision device, generally referenced 650,
660, 670.sub.1, 670.sub.2 and 690 respectively, constructed and
operative in accordance with another embodiment of the disclosed
technique. FIG. 14A shows an inner ring 650. Inner ring 650 is
shown in a cross sectional view. Inner ring 650 includes a
circumferential groove 652. A capturing ring 654 is placed over a
foreskin (not shown) inside circumferential groove 652. As shown in
FIG. 14A, circumferential groove 652 is asymmetrical along a
vertical axis 656. Due to the asymmetrical shape of circumferential
groove 652, capturing ring 654 rests in a section 658 of
circumferential groove 652. When inner ring 650 is placed around a
penis (not shown) section 658 may be distal or proximal to the
corona of the penis (not shown). The asymmetrical shape of
circumferential groove 652 may ease the placement of capturing ring
654 on inner ring 650. The asymmetrical shape of circumferential
groove 652 may also reduce the likelihood of capturing ring 654
accidentally falling off inner ring 650. In addition, the shape of
circumferential groove 652 may enable easier removal of capturing
ring 654 as well as any dry, dead foreskin (not shown) while
reducing the likelihood of touching any live tissue during such a
removal. In addition, if the increased curvature of circumferential
groove (i.e., section 658) is positioned towards the distal side of
the penis, the removal of capturing ring 654 and inner ring 650 may
be easier as the necrotic tissue to be cut can be cut substantially
close to capturing ring 654. Cutting the necrotic tissue
substantially close to capturing ring 654 substantially reduces the
amount of necrotic tissue that needs to pass over inner ring 650
before inner ring 650 is removed. Other asymmetrical shapes for
circumferential groove 652 are possible and are a matter of design
choice.
[0106] FIG. 14B shows an inner ring 660 from a top orthogonal view.
Inner ring 660 can be opened and closed using a mating mechanism.
Inner ring 660 includes a female connector 662 and a male connector
664. Female connector 662 and male connector 664 have complementary
shapes. The shapes of female connector 662 and male connector 664
in inner ring 660 are merely examples. Other shapes for female
connector 662 and male connector 664 are possible and are a matter
of design. Inner ring 660 is closed by inserting male connector 664
in female connector 662. As FIG. 14B shows a top orthogonal view of
inner ring 660, male connector 664 may be inserted into female
connector 662 in a direction perpendicular to the plane of FIG.
14B. As inner ring 660 can be opened and closed, inner ring 660 may
be more easily inserted into the opening of the foreskin of an
individual (not shown) and then subsequently closed around the
corona of the glans penis (not shown) of the individual.
[0107] FIGS. 14C and 14D show an inner ring in a cross sectional
view, generally referenced 670.sub.1 and in a top orthogonal view,
generally referenced 670.sub.2. Inner rings 670.sub.1 and 670.sub.2
include a circumferential groove 672, an inner lip 674, an outer
lip 678 and an opening 676. As shown in more detail in FIG. 14E, a
penis (not shown) in inserted into opening 676 in the direction of
an arrow 675. Unlike other inner rings of the disclosed technique
described above, the radial direction of circumferential groove
672, shown as an arrow 677, is parallel to the direction in which
the penis is inserted into opening 676 (i.e., the direction of
arrow 675). In other inner rings of the disclosed technique, such
as inner ring 104 (FIG. 2B), the radial direction of the
circumferential groove is perpendicular to the direction in which
the penis is inserted into the opening of the inner ring. As shown
in FIGS. 14C and 14D, inner lip 674 is slightly larger than outer
lip 678. Inner lip 674 includes an overhang 688 over
circumferential groove 672. FIG. 14E shows how inner ring 670.sub.1
(FIG. 14C) is used with the disclosed technique as a bloodless
circumcision device, generally referenced 690. FIG. 14E shows a
penis (not labeled) including a shaft 680, a glans 682 and a
foreskin 684. As shown, foreskin 684 is stretched over inner ring
670.sub.1 which is inserted over glans 682 through opening 676.
Foreskin 684 is pulled over outer lip 678, inserted into
circumferential groove 672 and then pulled over inner lip 674. A
capturing ring 686 is then inserted into circumferential groove
672, thereby compressing foreskin 684 between capturing ring 686
and inner lip 674, causing ischemic necrosis to foreskin 684. An
overhang 688 of inner lip 674 substantially prevents capturing ring
686 from unintentionally slipping out of circumferential groove
672.
[0108] According to the disclosed technique, a bloodless
circumcision device is applied to the foreskin (not show) of a
penis (not shown), causing the foreskin to undergo ischemic
necrosis, resulting in tissue death of the foreskin tissue. In
certain cases, after a few days, the necrotic foreskin may fall off
naturally. In other cases, it may take between a week to two weeks
for the necrotic foreskin to fall off naturally. In either case,
since the tissue in the foreskin is substantially dead after a few
days, according to the disclosed technique, the dead foreskin may
be removed using a foreskin cutter without having to wait until the
dead foreskin falls off naturally. In general, necrosis of the
foreskin according to the disclosed technique leads to dry gangrene
(i.e., tissue death without subsequent bacterial decomposition).
The necrotic foreskin becomes substantially dry, and in many cases
the necrotic foreskin also hardens. Regular or tailored scissors or
cutters can then be used to remove the dead tissue. Various
embodiments of such a foreskin cutter are shown below in FIGS.
15A-15D, 16A-16D and 17A-17B. Each of these embodiments enables a
necrotic foreskin to be removed simply and safely in a consistent
and standardized manner. These factors are relevant for providing a
safe and scalable device for bloodless circumcisions on a large
scale.
[0109] Reference is now made to FIGS. 15A-15D, which are schematic
illustrations showing different views of a foreskin cutter,
generally referenced 720, constructed and operative in accordance
with a further embodiment of the disclosed technique. Identical
elements in FIGS. 15A-15D are labeled using identical numbers.
Foreskin cutter 720 is used to cut and remove a dead foreskin (not
shown) from a penis (not shown) on which the bloodless circumcision
device (not shown) of the disclosed technique was applied. FIG. 15A
shows foreskin cutter 720 in a side orthogonal view. Foreskin
cutter 720 includes two pressure grips 722A and 722B, a connector
724, two inner ring holders 726A and 726B and two cutters 728A and
728B. Connector 724 couples pressure grip 722A with pressure grip
722B. Cutters 728A and 728B are coupled with inner ring holders
726A and 726B respectively. Cutters 728A and 728B may be embodied
as small and sharp blades, pins or needles. Alternatively, cutters
728A and 728B may be designed or fabricated from a material
suitable to only cut through hardened, dry or dead skin tissue,
thereby increasing the safety of foreskin cutter 720 in the event
it is accidentally used on live skin tissue. For example, cutters
728A and 728B may be designed having a coarse surface which can cut
through dry or dead skin tissue but not through soft, live skin
tissue. Inner ring holders 726A and 726B are coupled with pressure
grips 722A and 722B and with connector 724. Pressure grips 722A and
722B, connector 724 and inner ring holders 726A and 726B can be
fabricated as a single element made from a semi-hard plastic, for
example. Foreskin cutter 720 is generally shaped like the Greek
letter omega in capital form (S2), having one side open. Connector
724 is flexible enough that pressure grips 722A and 722B can be
pulled in an outward radial direction, shown as arrows 729.
Pressure grips 722A and 722B are substantially large enough that a
finger can respectively be placed on each one.
[0110] Foreskin cutter 720 is used as follows. An inner ring 730,
along with a capturing ring 732 are placed around the foreskin (not
shown) of a penis (not shown), as described above in various
embodiments of the disclosed technique. Once the foreskin has died,
foreskin cutter 720 is used to excise the dead foreskin. In FIG.
15A, the location of the penis is such that the penis is inserted
into inner ring 730 in the direction of an arrow 723. Therefore,
the foreskin located between capturing ring 732 and inner ring
holders 726A and 726B, and any excess foreskin located beyond inner
ring holders 726A and 726B in the direction of arrow 723, is dead
foreskin. Any foreskin located before capturing ring 732 and
foreskin cutter 720 is live foreskin. The foreskin therefore
extends above and below capturing ring 732. Foreskin cutter 720 is
positioned over inner ring 730 by pulling pressure grips 722A and
722B in the direction of arrows 729, positioning inner ring holders
726A and 726B adjacent to inner ring 730 and then releasing the
pulling motion on pressure grips 722A and 722B such that inner ring
holders 726A and 726B fit around inner ring 730. Optionally,
pressure grips 722A and 722B may be compressed inwardly, thereby
applying inward radial pressure to inner ring 730 (i.e., in
opposite directions of arrows 729). As shown below in FIG. 15B,
inner ring holders 726A and 726B are shaped to hold inner ring 730
firmly in place.
[0111] As inner ring holders 726A and 726B are positioned adjacent
to inner ring 730, cutters 728A and 728B substantially pierce the
foreskin (not shown) which is flush against inner ring 730 at
sections 734A and 734B of inner ring 730. This is shown more
clearly in FIG. 15C. As mentioned above, the foreskin in this area
is dead foreskin. Pressure grips 722A and 722B are gripped by two
fingers (not shown) and pressure is exerted radially inward towards
inner ring 730. By exerting an inward radial pressure, cutters 728A
and 728B cut through the foreskin at sections 734A and 734B
eventually touching inner ring 730. Using pressure grips 722A and
722B, foreskin cutter 720 is then rotated, thereby enabling cutters
728A and 728B to cut the remainder of the foreskin. Depending on
the thickness of the foreskin (not shown), cutters 728A and 728B
may not fully pierce the foreskin. In such a scenario, foreskin
cutter 720 is rotated while an inward pressure from pressure grips
722A and 722B is exerted, thereby gradually peeling away the dead
layers of skin tissue attaching the necrotic foreskin to the
penis.
[0112] FIG. 15B shows a close-up perspective view of pressure grip
722A and inner ring holder 726A. Inner ring holder 726A includes a
cutter 728A, an upper lip 736, a lower lip 738 and a groove 740.
Upper lip 736 is substantially larger than lower lip 738 thereby
preventing inner ring 730 (FIG. 15A) from sliding past upper lip
736. Upper lip 736 also enables only the distal outer surface of
inner ring 730 (in reference to the penis inserted in inner ring
730 in the direction of arrow 723 (FIG. 15A) as shown in FIG. 15A)
to be cut by the cutters and not other sections of inner ring 730
or other objects, thereby increasing the safety of foreskin cutter
720. In addition, upper lip 736 adds increased support to the
coupling of the inner ring holders to an inner ring. Groove 740 is
curved to substantially match at least one of the distal end or the
proximal end of inner ring 730. Upper lip 736, lower lip 738 and
groove 740 substantially fit into inner ring 730, thereby gripping
inner ring 730 and holding it firmly in place. FIG. 15C shows a
close-up side orthogonal view of pressure grip 722A and inner ring
holder 726A used with inner ring 730. As shown, upper lip 736
prevents inner ring 730 from sliding any further into foreskin
cutter 720 in the direction of an arrow 731. When pressure is
applied at pressure grip 722A, cutter 728A substantially touches
inner ring 730 at section 734A. When used on a penis (not shown),
the foreskin (not shown) of the penis is sandwiched between groove
740 and section 734A of inner ring 730. Cutter 728A can thus cut or
peel away the foreskin. Cutter 728A does not touch capturing ring
732. FIG. 15D shows foreskin cutter 720 in a perspective view. As
shown in FIG. 15D, pressure grips 722A and 722B can be embodied as
being slightly concave, thereby facilitating the gripping of the
pressure grips via the fingers (not shown). Also as shown, once
pressure is applied to pressure grips 722A and 722B and the
foreskin (not shown) is pierced, foreskin cutter 720 is rotated in
the direction of an arrow 742. As foreskin cutter 720 is rotated in
the direction of arrow 742, groove 740 and cutters 728A and 728B
(all not shown in FIG. 15D) substantially slide around the outer
circumference of inner ring 730. Cutters 728A and 728B
substantially cut or peel away the foreskin such that it can be
excised. As shown in FIGS. 15A, 15C and 15D, upper lip 736 enables
foreskin cutter 720 to only fit around the outer side of inner ring
730 (for example, the areas denoted by sections 734A and 734B).
Upper lip 736, lower lip 738 and groove 740 are substantially
shaped to match the shape of the outer surface of inner ring 730,
thereby increasing the safety of foreskin cutter 720 by
substantially enabling cutters 728A and 728B to cut only when inner
ring holders 726A and 726B substantially couple with inner ring
730. Hence, the structure of foreskin cutter 720 does not allow it
to be mistakenly placed on inner ring 732 or on the inner side of
inner ring 730, where skin tissue on the penis may still be alive
and healthy. As such, cutters 728A and 728B of foreskin cutter 720
will only cut, peel and remove dead, necrotized foreskin and not
living tissue.
[0113] Foreskin cutter 720 may be supplied in a kit or can be
provided as a supplementary instrument with the bloodless
circumcision device of the disclosed technique, including at least
an inner ring as described above. In some embodiments, the foreskin
cutter cannot cut through foreskin tissue unless coupled with an
already deployed inner ring (not shown) such that together the
foreskin cutter and the inner ring function as a foreskin tissue
holding and removing system.
[0114] Reference is now made to FIGS. 16A-16D, which are schematic
illustrations showing different views of another foreskin cutter,
generally referenced 760, constructed and operative in accordance
with another embodiment of the disclosed technique. FIG. 16A shows
foreskin cutter 760 from a top orthogonal view. Foreskin cutter 760
includes an open ring 762, a grip 764 and inner ring holders 766A,
766B and 766C. Open ring 762 has an opening 768, enabling open ring
762 to be stretched in the direction of arrows 765. Inner ring
holders 766A, 766B and 766C each respectively include an upper lip
772A, 772B and 772C and a lower lip 774A, 774B and 774C. As shown,
lower lips 774A, 774B and 774C jut out of open ring 762 slightly
more than upper lips 772A, 772B and 772C. The areas between the
upper lips and the lower lips (not shown in FIG. 16A) respectively
form a groove (not shown). Grip 764 is coupled with open ring 762
and is centered on open ring 762. Grip 764 can be gripped by at
least two fingers. Inner ring holders 766A, 766B and 766C are
coupled with open ring 762 and are evenly spaced around open ring
762. FIGS. 16B and 16C show perspective views of foreskin cutter
760. In FIGS. 16B and 16C, a groove 776 in inner ring holder 766B
is visible. Similar grooves exist in inner ring holders 766A and
766C. Centered in groove 776 is a cutter 770. Cutter 770 may be
embodied as a pin. Cutter 770 may also be fabricated from a
material suitable to only cut through hardened, dry or dead skin
tissue, thereby increasing the safety of foreskin cutter 760 in the
event it is accidentally used on live skin tissue. Upper lip 772B
and lower lip 774B cover cutter 770 thereby preventing cutter 770
from accidentally cutting and damaging skin or an individual while
foreskin cutter 760 is handled.
[0115] FIG. 16D shows how foreskin cutter 760 is used to excise a
dry foreskin (not shown) before it falls off by itself. Unlike
foreskin cutter 720 (FIGS. 15A-15D), which was placed vertically
over the foreskin, foreskin cutter 760 is place horizontally around
the foreskin. FIG. 16D includes an inner ring 778 and a capturing
ring 780, which is placed in a circumferential groove 784 of inner
ring 778. The diameter of open ring 762 is slightly larger than the
diameter of inner ring 778. Once inner ring 778 and capturing ring
780 have been placed on the foreskin and the foreskin has become
necrotic, open ring 762 is stretched in the direction of arrows 765
(FIG. 16A) and placed around the upper rim (not shown) of inner
ring 778. The grooves in inner ring holders 766A, 766B and 766C
firmly fit around the upper rim of inner ring 778. Upper lips
772A-772C and lower lips 774A-774C are shaped to firmly hold the
upper rim of inner ring 778 in place and to prevent foreskin cutter
760 from being placed around capturing ring 780, around the lower
rim (not shown) of inner ring 778 or from sliding down inner ring
778. Cutter 770 is located in groove 776 such that when foreskin
cutter 760 is placed around inner ring 778, cutter 770 pierces the
dry foreskin above capturing ring 780. By gripping grip 764,
foreskin cutter 760 can be rotated in either direction shown by an
arrow 782 around the upper rim of inner ring 778. The groove
between upper lips 772A-772C and lower lips 774A-774C, such as
groove 776, enable foreskin cutter 760 to be rotated around inner
ring 778. By rotating foreskin cutter 760 around inner ring 778,
cutter 770 peels and cuts the dry foreskin, substantially excising
the foreskin.
[0116] It is noted that foreskin cutters 720 (FIGS. 15A-15D) and
760 (FIGS. 16A-16D) can also be used to excise foreskin which is
not necrotic but still alive. In such an embodiment, cutters 728A,
728B (FIGS. 15A-15D) and 770 (FIGS. 16A-16D) should be sharp such
that they can cut through live skin tissue. This embodiment of the
foreskin cutters may be used to excess the foreskin of a penis (not
shown) when the foreskin is held, clamped or positioned using a
prior art circumcision device.
[0117] Reference is now made to FIGS. 17A-17B, which are schematic
illustrations showing a further foreskin cutter, generally
referenced 800 and 820 respectively, constructed and operative in
accordance with a further embodiment of the disclosed technique.
FIG. 17A shows a foreskin cutter 800, substantially constructed
from a suture string 801. The suture string 801 is either knotted
or glued at a point 802, thereby forming a teardrop shape. Suture
string 801 can be knotted or glued to form other closed shapes as
is obvious to one skilled in the art. Suture string 801 includes a
roughened section 806. Roughened section 806 may be sharp, toothed,
abrasive and the like. As shown, roughened section 806 forms only a
part of suture string 801, depicted in FIG. 17A as a section 804.
Roughened section 806 is substantially opposite point 802. The
diameter of suture string 801 is larger than the diameter of an
inner ring.
[0118] FIG. 17B shows how the foreskin cutter of FIG. 17A is used
to excise a dry and dead foreskin. FIG. 17B shows a side orthogonal
view of the bloodless circumcision device used on a penis (not
shown). The penis includes a shaft 822 and a foreskin 824. An inner
ring 826 is placed around shaft 822 between shaft 822 and foreskin
824. Foreskin 824 is inserted into a circumferential groove 830 of
inner ring 826. A capturing ring 828 is then placed around
circumferential groove 830, thereby causing controlled ischemic
necrosis to a portion of foreskin 824. After a period of a few
hours, the portion of foreskin 824 above capturing ring 828, shown
as a necrotic portion 832, begins to die. After a period of a few
days, necrotic portion 832 is completely dead and dry. Once
necrotic portion 832 is completely dry, a foreskin cutter 834,
similar to foreskin cutter 800 (FIG. 17A), is placed around
foreskin 824 at the base of necrotic portion 832. Foreskin cutter
834 is substantially a closed shape suture string have a roughened
portion 836. Roughened portion 836 is placed against the base of
necrotic portion 832 and foreskin cutter 834 is pulled such that
roughened portion 836 abuts against the base of necrotic portion
832. Foreskin cutter 834 is then rotated horizontally around shaft
822. As foreskin cutter 834 is rotated around, roughened portion
836 substantially abrades and peels through necrotic portion 832,
thus excising the necrotic portion of the foreskin.
[0119] Reference is now made to FIGS. 18A-18D, which are schematic
illustrations showing a capturing ring deployment system, generally
referenced 850, constructed and operative in accordance with
another embodiment of the disclosed technique. Capturing ring
deployment system 850 includes a ring holder 852, a capturing ring
854 and an inner ring 856. Inner ring 856 includes a
circumferential groove 858. Ring holder 852 includes three flanges
860A, 860B and 860C. Each of flanges 860A-860C respectively
includes a raised edge 862A, 862B and 862C as well as a resting
surface 864A, 864B and 864C. Ring holder 852 is substantially
annular in shape having an opening 853. Ring holder 852 can be
constructed as other closed shapes and is a matter of design
choice. For example, ring holder 852 can be shaped as a convex
polygon. In general, ring holder 852 has a diameter which is larger
than inner ring 856 and capturing ring 854, although in other
embodiments of the disclosed technique, ring holder 852 has a
diameter which is substantially at least equal to a diameter of a
shaft of a penis (not shown). If ring holder 852 has a convex
polygonal shape, then the diameter of an inscribed circle in the
polygonal shape should be at least equal to a diameter of the shaft
of the penis. Flanges 860A-860C are evenly spaced around ring
holder 852. Ring holder 852 may optionally include more than three
flanges (not shown). Raised edges 862A-862C extend from resting
surfaces 864A-864C on the inner side of ring holder 852. Ring
holder 852 is used to hold capturing ring 854 in a stretched state
while inner ring 856 is positioned around a penis (not shown). Ring
holder 852 is also used to aid in positioning inner ring 856 at its
desired position around the penis, when capturing ring 854 in its
stretched state substantially couples ring holder 852 to inner ring
856. Ring holder 852 is further used to transfer capturing ring 854
in its stretched state to circumferential groove 858 when inner
ring 856 has been properly positioned. FIGS. 18A-18D show the
various stages of how capturing ring deployment system 850 is
used.
[0120] In FIG. 18A, the various elements of capturing ring
deployment system 850 are shown as separate elements. In FIG. 18B,
capturing ring 854 is stretched around flanges 860A-860C. In its
stretched state, capturing ring 854 rests on the resting surfaces
of ring holder 852, such as resting surface 864A. The raised edges
of ring holder 852, such as raised edge 862A, retain capturing ring
854 in its stretched state. Due to the position and number of
flanges 860A-860C, when capturing ring 854 is stretched around the
flanges, capturing ring 854 assumes a substantially triangular
shape. If ring holder 852 included four flanges (not shown), then
when capturing ring 854 would be stretched around the flanges,
capturing ring 854 might assume a square shape (not shown), a
trapezoid shape (not shown) or a quadrilateral shape (not shown)
depending on the relative positions of the flanges. Accordingly, a
plurality of more than three flanges can be located on ring holder
852 thereby giving capturing ring 854 a convex polygonal shape,
depending on the number and relative positions of the flanges. As
shown, when stretched around the flanges, three sections of
capturing ring 854, sections 866.sub.1, 866.sub.2 and 866.sub.3
rest on the resting surfaces, representing vertex-like sections of
capturing ring 854. The remaining sections of capturing ring 854,
shown as edge sections 868.sub.1, 868.sub.2 and 868.sub.3 become
taut and represent edge-like sections of capturing ring 854. As
described in greater detail in FIG. 18C, the relative distances
between edge sections 868.sub.1, 868.sub.2 and 868.sub.3 are such
that the diameter of inner ring 856 is slightly larger than the
diameter of an inscribed circle in capturing ring 854 in its
stretched state.
[0121] In FIG. 18C, inner ring 856 is placed within ring holder 852
and capturing ring 854 such that the edge sections of capturing
ring 854, such as edge section 868.sub.1, are positioned within
circumferential groove 858. Since the diameter of inner ring 856 is
slightly larger than the diameter of an inscribed circle in
capturing ring 854 in its stretched state, capturing ring 854
clasps inner ring 856. Inner ring 856 is held by capturing ring 854
at three positions along the edge sections of capturing ring 854
due to the presence of three flanges on ring holder 852. One such
position is shown in FIG. 18C by a dotted circle 870 (the other two
are not visible in FIG. 18C). The pressure exerted by the edge
sections of capturing ring 854 on inner ring 856 is strong enough
such that if capturing ring deployment system 850 as shown in FIG.
18C were placed around the shaft of a penis (not shown),
displacement of inner ring 856 would cause capturing ring 854 and
ring holder 852 to displace respectively. In FIG. 18C, ring holder
852, capturing ring 854 and inner ring 856 are substantially
coupled together by inward radial compression forces (not shown) of
capturing ring 854 on flanges 860A, 860B (not shown in FIG. 18C)
and 860C (not shown in FIG. 18C) and on sections of inner ring 856,
such as the section shown by dotted circle 870, thereby forming a
single moveable unit. Capturing ring deployment system 850 as shown
in FIG. 18C can be positioned over the penis at a desired position.
At the desired position, ring holder 852 is held, for example by
the hand or an element and the sections where inner ring 856 and
capturing ring 854 touch (as denoted by dotted circle 870) are also
held, for example by another hand or another element. Ring holder
852 is then pulled in a direction away from inner ring 856 and
inner ring 856 and capturing ring 854 are optionally pulled in the
opposite direction away from ring holder 852, thereby releasing
capturing ring 854 from flanges 860A-860C. Capturing ring 854 is
then positioned within circumferential groove 858, as shown in FIG.
18D.
[0122] Reference is now made to FIGS. 19A-19K, which are schematic
illustrations showing the method of use of the capturing ring
deployment system of FIGS. 18A-18D with a bloodless circumcision
device, constructed and operative in accordance with a further
embodiment of the disclosed technique. Identical elements in FIGS.
19A-19K are labeled using identical numbers. FIGS. 19A-19K show the
various steps of using the bloodless circumcision device of the
disclosed technique with the capturing ring deployment system of
FIGS. 18A-18D, each step demonstrating how the capturing ring
deployment system and the bloodless circumcision device are applied
to the penis of an individual to circumcise the individual.
[0123] A first step is shown in FIG. 19A. FIG. 19A shows a penis
(not labeled) which includes a shaft 900, a foreskin 902 and a
foreskin opening 904. In this step, a line, such as a dotted line
906, is marked on foreskin 902 where the individual desires to have
his penis circumcised. Dotted line 906 is substantially located on
foreskin 902 and not on shaft 900. Dotted line 906 is marked with
non-toxic marker for example. After dotted line 906 is marked, a
size selector, such as shown below in FIG. 20, for determining the
appropriate size of a bloodless circumcision device to be used on
the individual is used to determine to correct size capturing ring
and inner ring to be used on the individual. This step is not
depicted in FIGS. 19A-19K. In an alternative to this step, a
variable sized inner ring (not shown) may be used and set to a
desired size after measurement of the penis or upon deployment of
the inner ring, as shown below in FIG. 19D, over the penis. A
second step is shown in FIG. 19B. In this step, the selected
capturing ring, shown in FIG. 19B as a capturing ring 910, is
stretched around a ring holder, shown in FIG. 19B as a ring holder
908. Ring holder 908 and capturing ring 910 substantially represent
a capturing ring deployment system and are herein referred to as
such in FIGS. 19A-19K. This is not depicted in FIG. 19B. Ring
holder 908 and capturing ring 910 are then placed over foreskin 902
and shaft 900. Ring holder 908 and capturing ring 910 are placed
far enough along shaft 900 that foreskin 902 can be fully folded
back onto shaft 900 without touching the ring holder. A third step
is shown in FIG. 19C. In this step, opening 904 of foreskin 902 is
stretched open, shown by an arrow 912. Foreskin 902 may be
stretched open using the hands or using various instruments such as
clamps, clasps, tongs or known surgical tools. In an alternative to
this step, foreskin 902 may be pulled back over shaft 900 (not
shown), as was shown above in FIG. 2B.
[0124] A fourth step in shown in FIG. 19D. In this step, the
selected inner ring, shown in FIG. 19D as an inner ring 914, which
includes a circumferential groove 916, is inserted around the glans
(not shown) of the penis via opening 904, which is still held
stretched open, as depicted by an arrow 918. Alternatively, inner
ring 914 may be directly placed over the glans of the penis if
foreskin 902 is pulled back over shaft 900. In one embodiment of
the disclosed technique, inner ring 914 may be inserted through
opening 904 vertically such that an end section 915 of inner ring
914 touches the glans of the penis (not shown) or the corona of the
glans of the penis (not shown). The inner ring is then rotated to a
horizontal position, as depicted in FIGS. 19D and 19E, placing it
over the glans of the penis, substantially around the corona of the
glans of the penis. A fifth step is shown in FIG. 19E. In this
step, inner ring 914 is maneuvered around the glans of the penis
until the centerline of circumferential groove 916, depicted as a
centerline 920 in FIG. 19E, is substantially lined up with dotted
line 906. As shown, opening 904 is no longer held stretched open.
Also, as shown in FIG. 19E, centerline 920 does not need to
necessarily line up exactly with dotted line 906 in this step. For
purposes of clarity, inner ring 914, circumferential groove 916 and
centerline 920 are shown as dotted line. In an alternative to this
step, if foreskin 902 was pulled back along shaft 900, in this
step, foreskin 902 is pulled over inner ring 914, either using the
hands or an instrument. Inner ring 914 would then be maneuvered to
its desired position as described above. A sixth step is shown in
FIG. 19F. In this step, the capturing ring deployment system,
including ring holder 908 and capturing ring 910, is moved along
shaft 900 in the direction of an arrow 922 such that capturing ring
910 firmly grasps circumferential groove 916 of inner ring 914,
through foreskin 902, at a plurality of points or sections along
the circumference of inner ring 914. This was shown in greater
detail above in FIG. 18C. Ring holder 908, capturing ring 910 and
inner ring 914 are now all coupled together as a single unit via
inward radial compression forces (not shown) of capturing ring 910.
As can be seen, the diameter of ring holder 908 and the stretched
diameter of capturing ring 910 are larger than the diameters of
shaft 900 and the area of the penis around foreskin 902. In
addition, dotted line 906 is still not lined up exactly with
centerline 920 (not visible in FIG. 19F).
[0125] A seventh step is shown in FIG. 19G. In this step, the
capturing ring deployment system, depicted as a section 926, which
now includes inner ring 914, capturing ring 910 and ring holder
908, can be moved as a single unit in the direction of arrows
924.sub.1 or 924.sub.2 (i.e., distally or proximally along shaft
900) to align centerline 920 (not visible in FIG. 19G) of
circumferential groove 916 with dotted line 906 (not visible in
FIG. 19G). Alternatively, foreskin 920 may be pulled in the
direction of arrows 924.sub.1 or 924.sub.2 to align centerline 920
with dotted line 906. As shown, capturing ring 910 clasps
circumferential groove 916 with sufficient force such that foreskin
902 can be pulled distally or proximally along shaft 900 without
dislodging capturing ring 910 from ring holder 908. In addition,
the capturing ring deployment system grips foreskin 902 tight
enough such that foreskin 902 remains compressed between inner ring
914 and capturing ring 910 even while the capturing ring deployment
system is moved along the penis, yet not so tight that movement of
the capturing ring deployment system would dislodge capturing ring
910 from ring holder 908. An eighth step is shown in FIG. 19H. In
this step, ring holder 908 is pulled in the direction shown by
arrows 930 while capturing ring 910 and inner ring 914 are held in
place. Optionally, capturing ring 910 and inner ring 914 may be
slightly pulled in a direction opposite the direction of arrows
930. This motion dislodges capturing ring 910 from flanges 928 of
ring holder 908, which are visible in FIG. 19H, thereby positioning
capturing ring 910 within circumferential groove 916. Capturing
ring 910 now applies a compression force against inner ring 914,
thereby compressing foreskin 902 at dotted line 906 (not visible in
FIG. 19H). A ninth step is shown in FIG. 191. In this step, ring
holder 908 is removed from shaft 900 in the direction of an arrow
932. Since ring holder 908 has a diameter larger than the widest
point along the penis, ring holder 908 can be easily removed from
the penis once capturing ring 910 has been placed on inner ring
914.
[0126] A tenth step is shown in FIG. 19J. In this step, after a few
hours, foreskin 902 begins to discolor and dry up as necrosis of
the foreskin sets in. After a few days, foreskin 902 is dead and
dry. An eleventh step is shown in FIG. 19K. In this step, after a
few days and death of the foreskin, foreskin 902 is excised from
the penis, as shown by an arrow 936, thereby revealing a glans of
the penis 934. Foreskin 902 may naturally fall off or may be
excised using any of the foreskin cutters of the disclosed
technique described above in FIGS. 15A-15D, 16A-16D or 17A-17B, or
by using other devices for removing the foreskin, such as a pair of
scissors or a scalpel. It is noted that inner ring 914 and
capturing ring 910 as shown in FIGS. 19A-19K can be embodied using
any of the embodiments of inner rings and capturing rings disclosed
according to the disclosed technique. Once foreskin 902 has been
excised, inner ring 914 and capturing ring 910 can be removed, for
example by using a pairs of scissors to cut capturing ring 910 at
which point inner ring 914 can be released from the remaining
foreskin (not labeled in FIG. 19K) and removed from the penis.
[0127] Reference is now made to FIG. 20, which is a schematic
illustration of size selector for determining the appropriate size
of a bloodless circumcision device to be used on an individual,
generally referenced 950, constructed and operative in accordance
with another embodiment of the disclosed technique. Size selector
950 includes a plurality of holes 952A, 952B, 952C, 952D, 952E,
952F and 952G. Each one of holes 952A-952G represents a different
size inner ring of the bloodless circumcision device of the
disclosed technique and may be labeled by letters, numerals,
symbols and the like. The holes in size selector 950 are labeled
using the Latin letters A-G, for example. In general, size selector
950 is used by placing the flaccid penis (not shown) of an
individual through holes 952A-952G. In general, the smallest which
the flaccid penis can be inserted through easily represents the
size of the inner ring to be used on that individual. Size selector
950 is shaped as a circle although other shapes are possible. In
addition, size selector 950 may include more holes or fewer holes
than depicted in FIG. 20.
[0128] As described above in FIGS. 2A-2E and 19A-19K, an inner ring
of the disclosed technique is placed around the corona of the glans
of the penis, substantially around the sulcus formed between the
corona of the glans of the penis and the area where the foreskin is
attached to the shaft of the penis. One method for placing the
inner ring around the corona of the glans of the penis involves
pulling the foreskin back along the shaft of the penis, thereby
exposing the glans. The inner ring is then placed and the foreskin
is pulled over the inner ring. This procedure was shown above in
FIGS. 2B and 2C. Another method for placing the inner ring around
the corona of the glans of the penis involves stretching the
opening of the foreskin and inserting the inner ring through the
foreskin over the glans of the penis, and maneuvering the inner
ring to its marked position, substantially around the corona of the
glans of the penis. This was shown above in FIGS. 19C-19E. In
certain individuals it may be difficult to pull the foreskin over
the inner ring or to insert the inner ring via the opening of the
foreskin when a rigid inner ring is used. With such individuals, a
flexible inner ring may be used, which may simplify the placement
of the inner ring around the corona of the glans of the penis as
well as the pulling of the foreskin around the inner ring. In
addition, a varying diameter inner ring may be used, wherein the
diameter of the inner ring can be reduced while the inner ring is
positioned around the corona of the glans of the penis. Once
placed, the diameter of the inner ring can be increased to a
desirable size. Flexible inner ring embodiments are shown below in
FIGS. 21A-21G.
[0129] Reference is now made to FIGS. 21A-21G, which are schematic
illustrations of flexible inner ring shapes and configurations for
use with a bloodless circumcision device, constructed and operative
in accordance with a further embodiment of the disclosed technique.
The flexible inner ring shapes in FIGS. 21A-21G can also be
referred to as semi-rigid inner ring shapes, as they can be
somewhat deformed by applying an external force, yet cannot be
deformed to the extent that capturing rings of the disclosed
technique can be deformed. Reference is now made in particular to
FIGS. 21A and 21B. FIG. 21A shows an inner ring 970, including a
circumferential groove 972, in a cross sectional view. Inner ring
970 is flexible and can be deformed upon applying an external
force, as shown in FIG. 21B. The external force may be applied
manually and should be substantially high to prevent inner ring 970
from deforming unintentionally. Once the external force is removed,
inner ring 970 will return to its original shape. FIG. 21B shows
inner ring 970 from a top orthogonal view. FIG. 21B shows inner
ring 970 in two states. In a relaxed state 974.sub.1, when no
external pressure is applied to inner ring 970, inner ring 970
assumes a circular shape. In a compressed state 974.sub.2, when an
external pressure is applied to the sides of inner ring 970, shown
by arrows 978, inner ring 970 assumes an elongated, elliptical-like
shape. When the external pressure shown by arrows 978 is removed,
inner ring 970 assumes its relaxed state. As shown in reference to
a centerline 976, in the compressed state, the diameter of inner
ring 970 along its minor axis, shown by an arrow 977, is smaller
than the diameter of inner ring 970 in its relaxed state. Inner
ring 970 may be constructed such that in a relaxed state its
diameter can be compressed up to a predetermined percentage of its
length. For example, the diameter of inner ring 970 along its minor
axis may be able to be shortened by 30-40% in a fully compressed
state. Inner ring 970 can be manufactured from flexible materials
such as silicone, EPDM rubber and nitrile rubber (as known as NBR).
Inner ring 970 may also include a core flexible metal or a ring of
material embedded within the surface of inner ring 970, as
described below in FIGS. 21C-21G. Inner ring 970 may be placed in
its compressed state by compressing the sides of inner ring 970
with the fingers or with an instrument, such as forceps or
tweezers. In its compressed state, since inner ring 970 has a
significantly smaller diameter along its minor axis, inner ring 970
may be more easily inserted through the opening of the foreskin
(not shown). Once placed inside the foreskin and around the glans
of the penis (not shown), the external pressure on inner ring 970
is removed and inner ring 970 then resumes its relaxed state. Inner
ring 970 may then be maneuvered around the glans of the penis until
it positioned at its desired location.
[0130] Inner ring 970 can also be embodied as a spring in either
its axial direction or circumferential direction, similar to
capturing rings 300 (FIG. 7A) and 330 (FIG. 7D). In such an
embodiment, the diameter of the inner ring can be shortened by
applying a concentric inward radial force, for example, using the
fingers or by using an instrument for applying uniform pressure
around an inner ring, as described below in reference to FIGS.
21C-21G. With the diameter shortened, the foreskin of the penis may
be more easily pulled over the inner ring, at which point, the
radial force is removed and the inner ring returns to its larger,
expanded state diameter.
[0131] A flexible inner ring according to the disclosed technique
can also be manufactured from a plurality of materials and
elements. As each selected element, material or both may have
different mechanical properties, physical properties and uses,
specific elements and materials can be selected and combined to
provide a flexible inner ring having specific characteristics. This
is a matter of design choice and is known to the worker skilled in
the art. Examples of composite material flexible inner rings are
shown in FIGS. 21C-21G. Reference is now made to FIGS. 21C-21G
which show four example embodiments of composite material flexible
inner rings. FIGS. 21C-21F show the inner rings in cross sectional
views whereas FIG. 21G shows the inner ring of FIG. 21F in a
perspective view. Each of the inner rings shown in FIGS. 21C-21G is
substantially circular in shape. In FIG. 21C, an inner ring 980,
including a circumferential groove 982 is shown. Inner ring 980 is
composed of two materials, a first material 983 and a second
material 984. Second material 984 is completely contained within
first material 983. In FIG. 21C, second material 984 is
manufactured in the shape of a vertical ring, placed within first
material 983. It is obvious to a worker skilled in the art that
other types of shapes for second material 984 are possible and are
a matter of design choice. In FIG. 21D, an inner ring 990,
including a circumferential groove 992 is shown. Inner ring 990 is
composed of two materials, a first material 993 and a second
material 994. Second material 994 is coupled with first material
993, where the inner side of inner ring 990 is composed of second
material 994 and the outer side of inner ring 990 is composed of
first material 993. In FIG. 21D, second material 994 is
manufactured in the shape of a ring having a modified finger joint
(shown as a section 995 in FIG. 21D) coupling it with first
material 993. It is obvious to a worked skilled in the art that
other types of shapes and joints are possible for second material
994.
[0132] In FIG. 21E, an inner ring 1000, including a circumferential
groove 1002 is shown. Inner ring 1000 is composed of two materials,
a first material 1003 and a second material 1004. Second material
1004 is coupled with first material 1003, where the inner side of
inner ring 1000 is composed of second material 1004 and the outer
side of inner ring 1000 is composed of first material 1003. In FIG.
21E, second material 1004 is manufactured in the shape of a C-ring.
First material 1003 is manufactured such that the C-shape of second
material 1004 can be coupled with it. It is obvious to a worked
skilled in the art that other types of shapes are possible for
second material 1004 and first material 1003. In FIG. 21F, an inner
ring 1010, including a circumferential groove 1012 is shown. Inner
ring 1010 is composed of two materials, a first material 1013 and a
second material 1014. Second material 1014 is completely contained
within first material 1013. In FIG. 21F, second material 1014 is
manufactured in the shape of two horizontal rings, placed within
first material 1013. It is obvious to a worker skilled in the art
that other types of shapes for second material 1014 are possible
and are a matter of design choice. In FIG. 21G, the ring-like shape
of second material 1014 is shown more clearly in a perspective
view. It is obvious to a worker skilled in the art that second
material 1014 could be embodied as a single ring, as a plurality of
rings and as other shapes, all of which are a matter of design
choice.
[0133] In the embodiments shown in FIGS. 21C-21G, the outer areas
of the inner rings are made from a soft flexible material, shown
above as the first material. The inner rings are given strength and
semi-rigidity by embedding a stiffer material within the soft
flexible material, shown above as the second material. Whereas the
second material is stiffer than the first material, the second
material is substantially still a flexible, spring-like material.
The composition of the two materials enables the inner rings to be
deformed upon the application of an external pressure. Once the
external pressure is removed, the inner rings regain their original
shape. An external pressure can be applied to opposing sides of the
inner rings, such as shown above in FIG. 21B, thereby shortening
the diameter of the inner rings along their respective minor axes.
This may ease the inserting of the inner ring through the opening
of the foreskin. An external pressure can also be applied
uniformly, or concentrically around the sides of the inner rings,
thereby retaining their circular shape but reducing their overall
diameter. Uniform pressure may be applied by using an instrument
having two hemispherical members, such as forceps or tweezers
having hemispherical ends that meet to form a circle when the grips
of the forceps or tweezers are brought together. In the case of the
foreskin being pulled down, reducing the overall diameter of an
inner ring may simplify pulling the foreskin over the inner ring.
Once the foreskin has been pulled over the inner ring, the external
pressure is removed and the inner ring returns to its longer,
relaxed state diameter. Each of first materials 983, 993 and 1003
can be embodied as an elastomer, such as silicone or EPDM rubber,
for example. Each of second materials 984, 994, 1004 and 1014 can
be embodied as a spring-like flexible plastic, such as polyether
ether ketone (also known as PEEK), polycarbonate or polypropylene,
for example. Each of second materials 984, 994, 1004 and 1014 can
also be embodied as a spring-like metal, such as grade 304
stainless steel, flexible steel, Nitinol or any other shape memory
alloy, for example. In the case of inner ring 1010, second material
1014 can also be embodied as a spring-like flexible plastic, such
as PEEK or polycarbonate. In general, the materials used for inner
rings 970, 980, 990, 1000 and 1010 should be selected in
appropriate percentages such that the pressure from a capturing
ring (not shown) placed around such flexible inner rings does not
cause the flexible inner rings to deform or to contract and shorten
in diameter. For example, if the capturing ring exerts a
compression pressure of 0.5-10 atmospheres, which may be above the
required pressure for causing necrosis in skin tissue but less than
the pressure at which an individual will feel pain, then the
flexible inner rings shown in FIGS. 21-21G should be able to
maintain their relaxed, or expanded states, up to pressures of
approximately 3 atmospheres.
[0134] Reference is now made to FIGS. 22A-22G, which are schematic
illustrations of other inner ring shapes and configurations for use
with a bloodless circumcision device, constructed and operative in
accordance with a further embodiment of the disclosed technique.
FIGS. 22A and 22B show a first inner ring shape, generally
referenced 1050, and FIGS. 22C-22G show a second inner ring shape,
generally referenced 1070. Reference is now made to FIGS. 22A and
22B which show two perspective illustrations of first inner ring
shape 1050. First inner ring shape 1050 includes a lip 1052, a
plurality of protrusions 1054, a plurality of troughs 1056 and a
circumferential groove 1058. Lip 1052 substantially forms the
circumference of one end of first inner ring shape 1050 whereas
plurality of protrusions 1054 and plurality of troughs 1056
substantially form the circumference of the other end of first
inner ring shape 1050. Circumferential groove 1058 is located
between lip 1052 and plurality of protrusions 1054 and plurality of
troughs 1056. Each one of plurality of troughs 1056 is located
between two subsequent ones of plurality of protrusions 1054.
Plurality of protrusions 1054 and plurality of troughs 1056 are
spaced around the circumference of first inner ring shape 1050.
[0135] First inner ring shape 1050 is placed on a penis (not shown)
such that lip 1052 is proximal to the base of the penis and
plurality of protrusions 1054 and plurality of troughs 1056 are
distal to the base of the penis. When first inner ring shape 1050
is used with the bloodless circumcision device of the disclosed
technique (not shown), first inner ring shape 1050 is placed around
the glans (not shown) or corona (not shown) of the penis. A
foreskin (not shown) is then pulled over first inner ring shape
1050 and then a capturing ring (not shown) is positioned over the
foreskin over the area of circumferential groove 1058. As mentioned
above, first inner ring shape 1050 is positioned on the penis such
that after a few days, the portion of the foreskin over lip 1052 is
substantially live tissue whereas the portion of the foreskin over
plurality of protrusions 1054 and plurality of troughs 1056 is
necrotic. Due to the configuration of plurality of protrusions 1054
and plurality of troughs 1056, an instrument used to cut the
necrotic foreskin, such as a scalpel, a pair of scissors, the
foreskin cutters or removers described above in FIGS. 15A-17B, or
any other suitable instrument, can cut the necrotic foreskin
substantially adjacent to circumferential groove 1058 and the
capturing ring. Cutting the necrotic foreskin substantially close
to the capturing ring eases the removal of the inner ring from the
penis and reduces pain an individual may feel when the inner ring
is removed. Dead skin tissue is hard and not stretchable like live
skin tissue, therefore when the inner ring is removed from the
penis (after the foreskin is removed), any dead skin tissue still
coupled to the penis may cause sensations of pain as the inner ring
is removed, since the live skin tissue adjacent to the dead skin
tissue may have to stretch beyond its normal amount as the inner
ring is removed. Plurality of troughs 1056 substantially enables a
foreskin remover to cut the foreskin substantially close to the
capturing ring, thereby minimizing the amount of dead foreskin left
on the penis and easing the removal of the inner ring. In addition,
the configuration of plurality of protrusions 1054 and plurality of
troughs 1056 also reduces the likelihood of the foreskin adhering
to the surface of the inner ring as it dries, thereby also easing
the removal of the inner ring.
[0136] Reference is now made to FIGS. 22C-22G which show various
illustrations of second inner ring shape 1070. FIGS. 22C and 22D
show perspective views of second inner ring shape 1070. FIG. 22C
shows a schematic illustration of second inner ring shape 1070 and
FIG. 22D shows a more real-life illustration of second inner ring
shape 1070. FIG. 22E shows a side orthogonal view of second inner
ring shape 1070, FIG. 22F shows a top orthogonal view of second
inner ring shape 1070 and FIG. 22G shows a cross sectional view of
second inner ring shape 1070. As shown in FIGS. 22C and 22D, second
inner ring shape 1070 includes a plurality of protrusions 1072, a
circumferential groove 1074 and a plurality of troughs 1076. Unlike
FIGS. 22A and 22B, plurality of protrusions 1072 is located on both
ends of second inner ring shape 1070. Circumferential groove 1074
is substantially located and formed between plurality of
protrusions 1072 and plurality of troughs 1076. Each one of
plurality of troughs 1076 is substantially located between two ones
of plurality of protrusions 1072. As shown more clearly, in FIG.
22E, plurality of troughs 1076 substantially abut circumferential
groove 1074. Similar to first inner ring shape 1050, second inner
ring shape 1070 enables necrotic foreskin to be cut substantially
adjacent to a capturing ring (not shown) placed in circumferential
groove 1074. In addition, the configuration of plurality of
protrusions 1072 and plurality of troughs 1076 also reduces the
likelihood of the foreskin adhering to the surface of the inner
ring as it dries, thereby also easing the removal of the inner
ring. Since plurality of protrusions 1076 are located on both ends
of second inner ring shape 1070, second inner ring shape 1070 can
be placed either way over a penis (not shown) between the glans or
the corona (both not shown) and the foreskin (not shown). As shown
in FIG. 22F, in one embodiment, plurality of protrusions 1072 can
be evenly spaced around the circumference of second inner ring
shape 1070. FIG. 22G shows a cross section view of second inner
ring shape 1070 along a line 1078 in FIG. 22F. As can be seen in
FIGS. 22C, 22D and 22G, plurality of troughs 1076 depress in an
axial direction, shown by a plurality of arrows 1080 (not shown in
FIGS. 22C and 22D).
[0137] It is noted that the description of the embodiments of the
disclosed technique as well as the accompanying figures serve to
better understand the disclosed technique without limiting its
scope. It is obvious to a person skilled in the art that
adjustments, modifications and amendments to the accompanying
figures and the described embodiments of the disclosed technique
are possible and are within the scope of the disclosed technique.
It will be appreciated by persons skilled in the art that the
disclosed technique is not limited to what has been particularly
shown and described hereinabove. Rather the scope of the disclosed
technique is defined only by the claims, which follow.
* * * * *
References