WO2016179788A1

WO2016179788A1 - Kit, device, and method for shaping foreskin

Info

Publication number: WO2016179788A1
Application number: PCT/CN2015/078731
Authority: WO
Inventors: Jiun-Liang Su
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-05-12
Filing date: 2015-05-12
Publication date: 2016-11-17
Anticipated expiration: 2017-11-12
Also published as: CN110201290B; CN107427373B; CN110201290A; JP2018524027A; JP6524249B2; CN107427373A

Abstract

A kit (1000) for shaping the foreskin of a subject, includes a foreskin shaping device (110), an applicator (150), and a measuring device (170). The foreskin shaping device (110) has an elongated body (112) that is open at both ends (116A, 116B) and defines at least one fluid channel (114) therein. The applicator (150) has a base (156) and a plurality of fingers (152A, 152B, 152C) coupled with the base (156), and is configured to facilitate the foreskin shaping device (110) into the foreskin of the subject. The measuring device (170) has a cylindrical body (172), a sliding member (174), a tongue (176) and a translating member (178). The measuring device (170) is configured to measure a deformation level of the subject, and cooperates with the foreskin shaping device (110) and applicator (150) to perform the foreskin shaping.

Description

KIT, DEVICE, AND METHOD FOR SKAPING FORESKIN

BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION

The present disclosure relates to a foreskin shaping kit. More particularly, the disclosed invention relates to a foreskin shaping kit for shaping the foreskin of a subject in a non-invasive manner.

2. DESCRIPTION OF RELATED ART

Foreskin covers the penis glans and protects it from injury. For most infants, the foreskin is fused with the penis glans completely. During the growth of most male subjects, the preputial opening gets wider as the result of the retraction of the foreskin due to repeat erection, until it finally get separated from the penis glans, leaving it fully exposed when the foreskin is unfolded.

Phimosis is a condition in which the preputial opening is too small or the foreskin is fused with the penis and glans, so that the glans cannot be exposed from the foreskin. In clinical settings, the most common treatment for phimosis is surgery (e.g. circumcision or dorsal slit) . The circumcision or dorsal slit causes pain and discomfort to its recipient. Moreover, after the surgery, the glans of the subject will become exposed all the time. The lack of foreskin protection leaves the glans in direct contact with external objects (such as pants or underpants) , which, after a long term, may lead to the aging or keratinization of the subject’s glans.

In view of the foregoing, there exists in the related art a need of an improved foreskin shaping device, which may provide an alternative solution to the aforementioned problems in the clinical field.

SUMMARY

The following presents a simplified summary of the disclosure in order to provide a basic understanding to the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical members of the present invention or delineate the scope of the present invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.

To address the problems faced by the prior art, aspect (s) and/or embodiment (s) of the present disclosure provide (s) various devices and methods for shaping the foreskin of a subject.

In one aspect, the present disclosure is directed to a kit for shaping the foreskin of a subject. The kit comprises a foreskin shaping device, an applicator, and a measuring device. Structurally, the foreskin shaping device comprises an elongated body that is open at both ends and defines at least one fluid channel therein. The applicator comprises a base and a plurality of fingers. Each of the plurality of fingers is coupled to the base at one end thereof and is tapered toward the other end thereof, and the plurality of fingers gather together at the other end to form a pointed tip, thereby defining a first space for receiving the foreskin shaping device therein. The measuring device includes a cylindrical body, a sliding member, a tongue, a translating member, and a length measuring member. The cylindrical body has a front end and a rear end. The sliding member is disposed within the cylindrical body with one end being projected out of the rear end of the cylindrical body, and is configured to move along the longitudinal direction of the cylindrical body. The tongue is disposed on the outer surface of the cylindrical body, and is configured to stretch the subject’s foreskin and hold the preputial opening in an open state. The translating member is disposed within the cylindrical body, and is coupled with the sliding member and the tongue. The translating member is configured to cause the tongue to move away from the outer surface of the cylindrical body when the sliding member moves toward the front end of the cylindrical body. The length measuring member is disposed on the sliding member for measuring the deformation level of the foreskin of the subject.

According to one embodiment of the present disclosure, the measuring device of the present disclosure further comprises a pressure measuring unit, a calculation unit and a display unit. The pressure measuring unit is disposed on the surface of the tongue, and is configured to measure a pressure that is applied on the foreskin of the subject and generate a pressure signal. The calculation unit is disposed within the sliding member and coupled with the pressure measuring unit. Further, the calculation unit is configured to process the pressure signal sent from the pressure measuring unit and thereby generates a calculated value of the pressure signal. The display unit is disposed on the surface of the sliding member, and is coupled with the calculation unit. Further, the display unit is configured to display the calculated value.

In one embodiment, the length measuring member is a ruler. In another embodiment, the length measuring member is an optoelectronic device that is coupled with the calculation unit. Moreover, the optoelectronic device is configured to measure the deformation level of the foreskin of the subject after the preputial opening of the foreskin being held opened by and tongue of the measuring device and thereby generates a length signal； the calculation unit is configured to process the length signal sent from the optoelectronic device and thereby generates a calculated value of the length signal； and the display unit is configured to display the calculated value of length signal.

According to one embodiment of the present disclosure, the measuring member of present disclosure further comprises a rod disposed within the sliding member with one end being projected out of the rear end of the sliding member. Moreover, in one embodiment of the present disclosure, the measuring member further comprises a deformation member disposed within the sliding member and coupled with the rod. In optional embodiments, the deformation member is a spring or a piezoelectric device.

According to one embodiment of the present disclosure, the translating member of the measuring device is a multiple-compressed-fluid cylinder. In another embodiment, the translating member consists of multiple wedges.

According to one embodiment of the present disclosure, the kit further comprises a plunger coupled with the base of the applicator and configured to move along the longitudinal direction of the applicator within the first space, so as to help inserting the foreskin shaping device into the preputial opening of the subject.

In another aspect, the present disclosure is directed to a kit for shaping the foreskin of a subject comprising a foreskin shaping device and an applicator.

The foreskin shaping device in structure comprises an elongated body that is open at both ends and defines at least one fluid channel therein. The applicator comprises a base, and a plurality of fingers respectively coupled to the base at one end thereof and is tapered toward the other end thereof. Moreover, each finger is tapered at one end while the other end is coupled to the base, and the tapered ends of plurality of fingers gather together to form a pointed tip, thereby defines a first space for receiving the foreskin shaping device therein.

In yet another aspect, the present invention is directed to a measuring device for measuring the foreskin deformation level of the subject.

The measuring device includes a cylindrical body, a sliding member, a tongue, a translating member, and a length measuring member. The cylindrical body has a front end and a rear end. The sliding member is disposed within the cylindrical body with one end and is configured to move along the longitudinal direction of the cylindrical body. The tongue is disposed on the outer surface of the cylindrical body, and is configured to stretch the subject’s foreskin and hold the preputial opening open during use. The translating member is disposed within the cylindrical body, and is coupled with the sliding member and the tongue. The translating member is configured to cause the tongue to move away from the outer surface of the cylindrical body when the sliding member moves toward the front end of the cylindrical body. The length measuring member is disposed on the sliding member for measuring the deformation level of the foreskin of the subject.

In still another aspect, the present disclosure is directed to a measuring device for opening the preputial opening or measuring the foreskin deformation level of a subject. The measuring device comprises a pivot； a front holding element having in its body, an upper end, a lower end, and an extension member extended from one side of the body of the front holding element, in which the lower end of the front holding element is coupled to the pivot； a rear holding element having in its body, an upper end, a lower end, and an extension member extended from one side of the body of the rear holding element, in which the lower end of the rear holding element is coupled to the pivot； a length measuring member coupled to the front or the rear holding element and is configured to measure the foreskin deformation level of the subject； and a pressure measuring unit disposed on either the first or second extension member and is configured to measure a pressure being applied on the foreskin of the subject and thereby generates a pressure signal for determining the foreskin deformation level； wherein, when the respective upper ends of the front and rear holding elements are pressured to force them to come toward each other, the respective free ends of the extension members of the front and rear elements are separated from each other by a distance, thereby can hold the preputial opening of the subject in an open state.

In one embodiment, the measuring device may further comprise a calculation unit and a display. The calculation unit is disposed on either the front holding element or the rear holding element and coupled with the pressure measuring unit, wherein the calculation unit is configured to process the pressure signal sent from the pressure measuring unit and thereby generates a calculated value of the pressure signal. The display unit is disposed on the front holding element or the rear holding element and coupled with the pressure measuring unit, wherein the display unit is configured to display the calculated value of the pressure signal.

In one specific embodiment, the length measuring element is a ruler. In another embodiment, the length measuring element is made of one or more piezoelectric materials.

In one aspect, the present disclosure is directed to a method for shaping a foreskin of a subject. In particular, the method uses the above mentioned kit for shaping the foreskin of a subject.

According to embodiments of the present disclosure, the method includes steps of, placing the foreskin shaping device into the applicator so that it is disposed in the first space of the applicator； inserting the pointed tip of the applicator through the preputial opening into the foreskin of the subject； and pushing the foreskin shaping device disposed in the first space out of the pointed tip formed by the tapered ends of the plurality of fingers of the applicator so that the foreskin shaping device is disposed at the foreskin opening of the subject.

In one embodiment, the method of present disclosure further comprises the steps of, measuring the deformation level of the foreskin by use of the measuring device to generate a deformation data； and customizing the size of the foreskin shaping device based on the deformation data.

Many of the attendant features and advantages of the present disclosure will becomes better understood with reference to the following detailed description considered in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present description will be better understood from the following detailed description read in light of the accompanying drawings, where:

Figure 1 is a schematic drawing of the kit 1000 for shaping the foreskin of the subject in accordance with one embodiment of this invention；

Figure 2A and Figure 2B are schematic drawings respectively illustrating the internal structure of the measuring device 170 of Figure 1 before and after the insertion of the sliding member in accordance with various embodiments of the present disclosure；

Figure 3 is a schematic drawing of the foreskin shaping device 210 in accordance with one embodiment of this invention；

Figure 4 is a schematic drawing of the foreskin shaping device 310 in accordance with another embodiment of this invention；

Figure 5 is a schematic drawing of the applicator 250 in accordance with one embodiment of this invention；

Figure 6A and Figure 6B are schematic drawings respectively illustrating the external and internal structures of applicator 350 in accordance with another embodiment of this invention；

Figure 7A and Figure 7B are schematic drawings respectively illustrating the external and internal structures of the measuring device 270 in accordance with another embodiment of this invention；

Figure 8A and Figure 8B are schematic drawings respectively illustrating the external and internal structures of the measuring device 370 in accordance with still another embodiment of this invention；

Figure 9 is a schematic drawing of the translating member 678 in accordance with one embodiment of this invention；

Figure 10 a schematic drawing of the translating member 778 in accordance with another embodiment of this invention；

Figure 11 a schematic drawing of the translating member 878 in accordance with still another embodiment of this invention；

Figure 12A to Figure 12E are schematic drawings illustrating the method for shaping foreskin of the subject by use of a kit comprising the applicator 350 of Figure 6B, the measuring device 370 of Figure 8A and a foreskin shaping device 410 in accordance with one embodiment of this invention；

Figure 13A and Figure 13B are schematic drawings respectively illustrating the structures of the measuring device 500 in a non-operating and operating conditions in accordance with one embodiments of this invention； and

Figure 14A and Figure 14B are schematic drawings respectively illustrating the structures of the measuring device 600 in a non-operating and operating conditions in accordance with another embodiment of this invention.

In accordance with common practice, the various described features/members are not drawn to scale but instead are drawn to best illustrate specific features/members relevant to the present invention. Also, like reference numerals and designations in the various drawings are used to indicate like members/parts.

DESCRIPTION

The detailed description provided below in connection with the appended drawings is intended as a description of the present examples and is not intended to represent the only forms in which the present example may be constructed or utilized. The description sets forth the functions of the example and the sequence of steps for constructing and operating the example. However, the same or equivalent functions and sequences may be accomplished by different examples.

For convenience, certain terms employed in the specification, examples and appended claims are collected here. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of the ordinary skill in the art to which this invention belongs.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in the respective testing measurements. Also, as used herein, the term “about” generally means within 10％, 5％, 1％, or 0.5％ of a given value or range. Alternatively, the term “about” means within an acceptable standard error of the mean when considered by one of ordinary skill in the art. Other than in the operating/working examples, or unless otherwise expressly specified, all of the numerical ranges, amounts, values and percentages such as those for quantities of materials, durations of times, temperatures, operating conditions, ratios of amounts, and the likes thereof disclosed herein should be understood as modified in all instances by the term “about. ” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the present disclosure and attached claims are approximations that can vary as desired. At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Unless otherwise defined herein, scientific and technical terminologies employed in the present disclosure shall have the meanings that are commonly understood and used by one of ordinary skill in the art. Unless otherwise required by context, it will be understood that singular terms shall include plural forms of the same and plural terms shall include the singular. Specifically, as used herein and in the claims, the singular forms “a” and “an” include the plural reference unless the context clearly indicates otherwise. Also, as used herein and in the claims, the terms “at least one” and “one or more” have the same meaning and include one, two, three, or more.

The term “subject” is intended to refer to the male gender.

One aspect of this invention is to provide a kit for foreskin shaping that is novel, easy-to-operate, and safe. The kit of the present invention help expand the preputial opening of e the foreskin of the subject, thus is particularly suitable for subject with phimosis. The kit of the present invention comprises several non-invasive medical devices. Specifically, the present kit comprises a foreskin shaping device and an applicator. In an optional embodiment, the present kit further comprises a measuring device. Since the present kit provides a non-invasive way of shaping the foreskin, thus it will not cause unnecessary pain to the subject as compared to that of the conventional treatment for phimosis (e.g., surgery) .

Figure 1 is a schematic drawing of a foreskin shaping kit 1000 in accordance with one embodiment of this invention. As illustrated in Figure 1, the foreskin shaping kit 1000 comprises a foreskin shaping device 110, an applicator 150 and a measuring device 170. In particular, the foreskin shaping device 110 comprises an elongated body 112 that is open at both ends (116A and 116B) , and at least one fluid channel 114. In practice, a user (e.g., a subject having being diagnosed with phimosis) inserts the foreskin shaping device 110 into the foreskin by use of the applicator 150 through the preputial opening, and the foreskin shaping device 110 is left there for a sufficient period of time so as to help expand the preputial opening of the subject. While being disposed at the preputial opening, the foreskin shaping device 110 help stretch the foreskin around it, and therefore expands the preputial opening of the subject. Moreover, the design of the open ends (116A and 116B) and the fluid channel 114 of the foreskin shaping device 110 is advantageous in that the fluid channel 114 allows the passage of urine. Accordingly, the subject wearing the foreskin shaping device 110 can urinate without taking off the foreskin shaping device110. In this way, the present foreskin shaping device 110 can be worn for a long time without substantially affecting the daily life of the subject, and at the same time, enhance the shaping efficacy of the present foreskin shaping device 110.

The applicator 150 is configured to deliver the foreskin shaping device 110 through the preputial opening until it reaches a desired position in the foreskin. In structure, the applicator 150 has a base 156 and a plurality of the fingers (152A, 152B, 152C) respectively coupled to the base 156 at one ends and tapered toward the other ends. The plurality of the fingers (152A, 152B, 152C) gather together to form a pointed tip S and thereby defines a first space 154 for receiving the foreskin shaping device 110 therein so that in practice, the foreskin shaping device 110 may be pushed through the preputial opening of the subject.

According to various embodiments of the present disclosure, the base 156 may be in the shape of a ring or a rod. For example, the base 156 illustrated in Figure 1 is in the form of a rod. During use, the base 156 may serve as a holding element, which allows the user to hold and operate the applicator 150 of this invention. Of course, the above-mentioned shapes of the base 156 are provided for the purpose of illustration and various other modifications may be achieved by those having ordinary skill in the art without departing from the scope of the claimed invention.

The fingers (152A, 152B, 152C) of the applicator 150 are flexible, meaning each of the fingers may be stretched or expanded, accordingly, each of the fingers may be made of metal, plastic, or biodegradable materials. During operation, the foreskin shaping device 110 is first placed into the first space 154 of the applicator 150. Since one end of the fingers (152A, 152B, 152C) gather to form a pointed tip S, thus the first space 154 is narrower towards the tip S. Accordingly, in practice, while holding the applicator 150 in place via the rod 156, the user or the subject may apply a pressure to the fingers (152A, 152B, 152C) to open or expand the tip S formed by the gathered fingers so that the foreskin shaping device 110 received therein may be pushed out of the applicator 150 and into the preputial opening of the subject, and is left there so that it may serve the purpose of foreskin shaping via stretching the foreskin around the foreskin shaping device 110.

The structure of the measuring device 170 is depicted in Figure 1, Figure 2A and 2B. Figure 2A and Figure 2B are schematic drawings of internal structure of the measuring device 170 of Figure 1 during operation in accordance with various embodiments of the present disclosure. Referring to Figures 1, 2A, and 2B, the measuring device 170 has a cylindrical body 172, a sliding member 174, a tongue 176, a translating member 178 and a length measuring member 180. Specifically, the cylindrical body 172 has a front end F and a rear end R. The tongue 176 is disposed on the outer surface of the cylindrical body 172, and is configured to stretch the subject’s foreskin and hold the preputial opening in an open state. The sliding member 174 is disposed within the cylindrical body 172 with one end being projected out of the rear end R of the cylindrical body 172. Further, the sliding member 174 is configured to move along the longitudinal direction of the cylindrical body172. The translating member 178 is disposed within the cylindrical body 172 and coupled with the sliding member 174 and the tongue 176. In practice, the translating member 178 is configured to cause the tongue 176 to move away from the outer surface of the cylindrical body 172 when the sliding member 174 moves toward the front end F of the cylindrical body 172 (as shown in Figure 2B) . The length measuring member 180 is disposed on the sliding member 174 for measuring the deformation level of the foreskin of the subject.

According to optional embodiments, the length measuring member 180 may be a ruler or an optoelectronic device suitable for measuring the length changes of the stretched foreskin. For example, in the embodiment depicted in Figure 1, the length measuring device 180 is a graduated ruler. The graduation of the measuring device 180 is between about 0.1 cm to 5 cml； preferably, about 0.1 to 3.0 cm. Specifically, the graduation can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 or 5.0 cm.

As illustrated in Figure 2A, in the non-operating state, the tongue 176 lies flat on the outer surface of the cylindrical body 172. During operation, when the user pushes the sliding member 174 toward the front end F of the cylindrical body 172 thereby exerts a force on the translating member 178, which in turn pushes the tongue 176 away from the outer surface of the cylindrical body 172 in linear direction (see, Figure 2B) . When the sliding member 174 is retracted (i.e., moves toward the rear end R) , both the tongue 176 and the sliding member 174 returns to their respective original positions (i.e., the positions illustrated in Figure 2A) .

As could be appreciated, while being pushed, the distance for which the sliding member 174 moves within the cylindrical body 172 is proportional to the distance for which the tongue 176 moves away from the outer surface of the cylindrical body 172. Therefore, the foreskin deformation level of the subject can be detected by use of the measuring device 170.

Additionally, the distance for which the tongue 176 moves away from the cylindrical body 172 can be adjusted by those with ordinary skill in the art depending on actual needs. For example, the force applied to a child may be different from that to an adult. Alternatively, the size of foreskin shaping device 110 or the measuring device 170 may vary depending on the subject in need thereof.

According to various embodiments, the translating member 178 may be a compressed-fluid cylinder, or the translating member 178 consists of multiple wedges.

In one embodiment, the translating member 178 is a compressed-fluid cylinder, in which the number of the cylinders depends on the configuration of the tongues. In one example, two compressed-fluid cylinders are required； in another example, three compressed-fluid cylinders are required； in still another example, four compressed-fluid cylinders are required.

Alternative embodiments of the foreskin shaping device 110 are illustrated in Figure 3 and Figure 4.

Figure 3 is a schematic drawing of a foreskin shaping device 210 in accordance with one embodiment of this invention. Similar to the foreskin shaping device 110 depicted in Figure 1, the foreskin shaping device 210 also has an elongated body 212 that is open at both ends (216A and 216B) and a fluid channel 214 therein, except the elongated body 212 has a cross-section that is in a shape of C

Figure 4 is a schematic drawing of a foreskin shaping device 310 in accordance with another embodiment of this invention. In this embodiment, the elongated body 312 of the foreskin shaping device 310 has a cross-section that is in I shape, accordingly, each ends of the foreskin shaping device 310 has two openings (316A and 316B； 316C and 316D) and two fluid channels (314A and 314B) .

In one embodiment, instead of flat and smooth, the outer surface of the elongated body 312 is curved (e.g., Figure 4) so that it complies to the shape of the preputial opening of the subject for ameliorating the discomfort the wearer might experience when using the foreskin shaping device 310.

In addition, the foreskin shaping device in accordance with any of the embodiments of this invention may be used together with a medicine suitable for shaping the foreskin. For example, steroids may be applied on the surface of the elongated body of the foreskin shaping device so that the medicine is directly adsorbed by the foreskin (especially, the preputial opening) of the subject. Examples of the medicine include, but are not limited to, Rinderon, Rinderon VA, hydrocortisone acetate, and fluticasone propionate.

Other embodiments of the present applicator are depicted in Figure5 and Figure 6. Figure 5 is a schematic drawing of the applicator 250 in accordance with one embodiment of this invention. The applicator 250 has three fingers (252A, 252B, 252C) and a base 256. Referring to Figure 5, each of the fingers (252A, 252B, and 252C) is coupled to the base 256 at one end, and is tapered toward the other end. As illustrated, the base 256 has a ring shape； however, the present disclosure is not limited hereto. The fingers (252A, 252B, 252C) gather together at the tapered ends to form a pointed tip S and thereby forming a first space 254 for receiving the foreskin shaping device (not shown) therein. Since the tapered ends of the fingers (252A, 252B, and 252C) gather to form the pointed tip S, thus the first space 254 gets narrower toward the tapered ends. Accordingly, by pushing the foreskin shaping device toward to the pointed tip S of the applicator 250, a pressure is applied to the gathered fingers (252A, 252B, 252C) thereby opens up the pointed tip S formed by the gathered fingers (252A, 252B, 252C) and creates an opening that allows the foreskin shaping device to pass therethrough.

Figure 6A and Figure 6B are schematic drawings respectively illustrating the external and internal structures of the applicator 350. In this embodiment, the applicator 350 has three fingers (352A, 352B, and 352C) , a base 356 and a plunger 358. For the purpose of brevity, members that are similar to those of the applicator 250 of Figure 4 are not discussed, and hence, only members/parts that are different are described herein below.

In this embodiment, in addition to the first space 354 formed by the tapered fingers (352A, 352B, 352C) , a second space 360 is rendered by the base 356. The plunger 358 is coupled with the base 356, and may be pushed to move along the longitudinal direction of the base 356 or between the first space 354 and the second space 360, so as to facilitate the insertion of the foreskin shaping device 310 into the preputial opening of the subject.

Referring to Figure 6B, in which the foreskin shaping device 310 has been disposed within the second space 360 of the applicator 350. In practice, before use, the base 356 may be opened from one end to place the foreskin shaping device 310 inside the second space 360, the user then pushes the plunger 358 toward the direction of the tip S so as to move the foreskin shaping device 310 from the second space 360 into the first space 354, until it dislodges from the applicator 350 and out of the pointed tip S and into the preputial opening of the subject.

According to the various embodiments of this invention, the configuration of the first space 354 and the second space 360 may be modified by those having ordinary skill in art. For instance, the first space 354 may be smaller or larger than the second space 360； alternatively, the first space 354 may be equal to the second space 360. In addition, the foreskin shaping device can be disposed in the first space 354, the second space 360, or between the first space 354 and the second space 360.

In optional embodiments of this invention, the applicator or the foreskin shaping device of this invention is made of metal, plastic, or biodegradable materials.

Figure 7A is a schematic drawing illustrating the external structure of the measuring device 270 in accordance with one embodiment of this invention； Figure 7B is a schematic drawing illustrating the internal structure of the measuring device 270 of the Figure 7A. As depicted in Figure 7A and Figure 7B, the measuring device 270 of this embodiment has a cylindrical body 272, a sliding member 274, a rod 282, two tongues (276A and 276B) , a translating member 278 and a length measuring member 280.

In structure, the translating member 278 is disposed within the cylindrical body 272. Two tongues (276A and 276B) are symmetrically disposed on the surface of the hollow cylindrical body 272 and coupled with the translating member 278. The tongues (276A and 276B) are configured to stretch the subject’s foreskin and hold the preputial opening in an open state. The rod 282 is disposed within the sliding member, wherein one end of the rod is projected out of the rear end R of the sliding member 274, while the other end is coupled with the translating member 278. Furthermore, the rod 282 can move along the longitudinal direction of cylindrical body 272. The length measuring member 280 is a ruler, which is disposed on the surface and along the longitudinal direction of the sliding member 274. Further, the length measuring member 280 is configured to measure the deformation level of the foreskin of the subject.

During operation, when the user pushes the rod 282 move toward the front end F of the cylindrical body 272； the rod 282 exerts a force on the translating member 278 which in turn pushes the tongues (276A and 276B) away from the outer surface of the cylindrical body 272 in linear direction. When the sliding member 274 is retracted (i.e., moves toward the rear end R) , both the tongues (276A and 276B) and the rod 282 returns to the original positions.

Figure 8A is a schematic drawing illustrating the external structure of the measuring device 370 in accordance with one embodiment of this invention； Figure 8B is a schematic drawing illustrating the internal structure of the measuring device 370 of the Figure 8A. As depicted in Figure 8A and Figure 8B, the measuring device 370 of this embodiment has a cylindrical body 372, a sliding member 374, a rod 382, two tongues (376A and 376B) , two pressure measuring units (377A and 377B) , a calculation unit 386, a display unit 384, a translating member 378, a length measuring member 380 and a deformation member 388.

It should be noted that the translating member 378 of this embodiment consists of three compressed-fluid cylinders, and the length measuring member 380 is an optoelectronic device. More specifically, the optoelectronic device is an infrared or a laser-based measuring device.

For the sake of brevity, members that are similar to those of the measuring device 370 as depicted in Figure 7 are not discussed in this embodiment. In this embodiment, the measuring device 370 is designed to transform the physical deformation level of the foreskin to quantitative values (e.g., length or pressure) . Accordingly, the measuring device 370 aims at providing accurate quantitative values that reflect the pressure exerted on and/or the deformation level of the subject’s foreskin and/or preputial opening.

In structure, the pressure measuring units (377A and 377B) is disposed on the surface of the tongues (376A and 376B) , and is configured to measure a pressure that is applied on the foreskin of the subject and thereby generates a pressure signal. The length measuring member 380 is disposed on the sliding member 374, and is configured to measure the deformation level of the foreskin of the subject and thereby generates a length signal. Moreover, the calculation unit 386 is disposed within the sliding member 374 and electrically coupled with the pressure measuring units (377A and 377B) , the length measuring member 380 and the display unit 384. Further, the calculation unit 386 is configured to process the pressure signal sent from the pressure measuring unit (377A, 377B) or the length signal sent from the length measuring member 380 and thereby generates calculated values respectively correspond to the pressure signal and the length signal. The display 384 is disposed on the sliding member 374, and is configured to display the respective calculated values of the pressure signal and the calculated length signal.

In another embodiment, the length measuring member 380 is disposed within the sliding member 374 and coupled with the deformation member 388.

In particular, the pressure measuring units (377A and 377B) are made of piezoelectric materials. When a pressure is applied on the pressure measuring units (377A and 377B) , the pressure measuring units (377A and 377B) will generate pressure signals (e.g. potential difference) in relating to the pressures being applied thereon. The pressure signal is then transmitted to the calculation unit 386, which in turn calculates a value that corresponds to the pressure signal and displays the calculated value of the pressure signal on the display 384.

The deformation member 388 is disposed within the sliding member 374. One end of the deformation member 388 is coupled with the translating member 378 and the other end is couple with the rod 382 within the sliding member 374. In optional embodiments of this invention, the deformation member 388 is a spring or an optoelectronic device. Referring to Figure 8B, the deformation member 388 is a spring that helps translate the force exerted on the rod 382 by the user to the tongues (376A and 376B) .

Figure 9 to Figure 11 are schematic drawings of the translating member in accordance with various embodiments of this invention.

Referring to Figure 9, the translating member 678 is consisted of two compressed-fluid cylinders. The translating member 678 comprises a first cylinder 679 and a second cylinder 681 respectively connected to the sliding member and the tongue (not shown) . In practice, when the force is applied to the first cylinder 679, the other cylinder (e.g. second cylinder) will be expanded in linear direction. Furthermore, according to one preferred embodiment, multiple compressed-fluid cylinders may be used.

Furthermore, in other embodiments, the translating member is composed of multiple wedges. The numbers and arrangement of the wedges can be varied by those with ordinary skill in the art depending on actual needs. For example, the translating member comprises at least two wedges, three wedges or four wedges.

Figure 10 is a schematic drawing of the translating member 778 in accordance with one embodiments of this invention. As depicted in Figure 10, the translating member 778 of this embodiment comprises two wedges (779A and 779B) and a linkage member 783 coupled with the wedges. Structurally, the linkage member 783 connects to the sliding member (not shown) , and the wedge 779B connects to the tongue (not shown) . During operation, when an external force is applied to the wedge 779A, the wedge 779B will be pushed away from the wedge 779A in linear direction.

Figure 11 is a schematic drawing of the translating member 878 in accordance with another embodiment of this invention. As illustrated in Figure 11, the translating member 878 comprises three first wedges (879A, 879B and 879C) and a second wedge 881. As depicted in Figure 11, the second wedge 881 is conical in shape； the first wedges (879A, 879B and 879C) are disposed on the outer surface the second wedge 881. Moreover, the distance between any two adjacent first wedges (879A, 879B and 879C) is the same. In practice, when an external force is applied to the second wedge 881, the first wedges (879A, 879B and 879C) will be pushed away in linear direction concurrently.

A further aspect of the present disclosure is to provide a method of shaping the foreskin of the subject. The method of this invention is easy to use, fast-acting, safe, and non-invasive. The method of this invention may be performed by the physician or by the subject.

In general, the method comprises steps of: placing the foreskin shaping device into the applicator so that it is disposed in the first space； inserting the pointed tip of the applicator through the preputial opening of the subject； and pushing the foreskin shaping device disposed in the first space out of the pointed tip formed by the tapered ends of the plurality of fingers of the applicator and through the preputial opening of the subject. Furthermore, the method may further comprises the steps of: measuring the deformation level of the foreskin by use of the measuring device to generate a deformation data； and customizing the foreskin shaping device to the subject based on the deformation data collected by the measuring device.

Figure 12A to Figure 12E are schematic drawings illustrating the method for shaping foreskin of the subject by use of a kit comprising the applicator 350 of Figure 6, the measuring device 370 of Figure 8 and a foreskin shaping device 410 in accordance with one embodiment of this invention. First, to evaluate the foreskin deformation level of the subject, the user inserts the front end of the cylindrical body 372 through the preputial opening of the subject, and pushes the rod 382 so that the tongues (376A and 376B) are moved away from the cylindrical body 372 to stretch the foreskin F and to hold the preputial opening of the subject in an open state. At the same time, the pressure value and the deformation level (i.e., the changes in length of the foreskin) are respectively detected by the pressure measuring unit and the length measuring member of the measuring device 370 and thereby generate a deformation data. Then, the deformation data, including the pressure value and the deformation level of the foreskin, are displayed on the display 384. Then, the user may choose a suitable foreskin shaping device 410 (i.e., selecting a foreskin shaping device with an appropriate size) based on the deformation data. During the foreskin shaping procedure, the foreskin shaping device 410 is first placed into the second space 360 of the applicator 350. Then, the pointed tip S of the applicator 350 is inserted into the preputial opening of the subject. The plunger 358 is pushed toward the pointed tip S of the applicator 350 so that the selected foreskin shaping device 310 within the applicator 350 is pushed out of the pointed tip S and into the preputial opening of the subject and left there for a sufficient period of time to help shape the foreskin. Thereafter, the applicator 350 is removed from the foreskin of the subject.

In still another aspect, the present disclosure provides a measuring device 500. The measuring device 500 is configured to use with the foreskin shaping device according to any embodiment described herein.

Figures 13A and 13B are schematic drawings respectively illustrating the structures of the measuring device 500 in non-operating and operating conditions in accordance with various embodiments of the present disclosure. As illustrated in Figures 13A and 13B, the measuring device 500 comprises a pivot 590, and a front and rear holding elements (510, 520) respectively connected to the pivot 590. The front holding element 510 comprises in its body, an upper end 510U, a lower end 510L, and an extension member 550A extended from one side of the body of the front holding element 510. Similarly, the rear holding element 520 also comprises in its body, an upper end 520U, a lower end 520L, and an extension member 550B extended from one side of the body of the rear holding element 520. The lower end 520L of the rear holding element 520 is pivotally connected to the lower end 510L of the front holding element 510 via the pivot 590, accordingly, the front and rear holding elements (510, 520) may respectively rotate around the pivot 590. Preferably, each of the front and rear holding elements (510, 520) is formed as a one piece article.

Each extension members (550A, 550B) has a free end or a remote end (550AE, 550BE) that is away from the respective bodies of the front and rear holding elements (510, 520) . During the non-operating condition as illustrated in Figure 13A, the measuring device 500 is in a closed state, in which the respective free ends or remote ends (550AE, 550BE) of the two extension members (550A, 550B) are rest against each other thereby forming a closed conformation； whereas during operating condition, the measuring device 500 may be used with any afore-mentioned foreskin shaping device, in which the measuring device 500 with the two free ends (550AE, 550BE) in a closed conformation are first inserted into the preputial opening of the subject, then by pressuring the front and rear holding elements (510, 520) to force them to come close to each other, the two free ends (550AE, 550BE) of the respective extension members (550A, 550B) will then be separated from each other by a distance thereby forming an open conformation (i.e., in an open conformation, Figure 13B) and may be used to hold the preputial opening in an opened state by stretching the foreskin of the subject. Moreover, in one embodiment, the space (C) is formed between the two extension members (550A, 550B) of the front and rear holding elements (510, 520) of the foreskin measuring device 500.

According to one optional embodiment, the measuring device 500 further includes a length measuring member 560 connected to the upper end 520U of the rear holding element 520. Preferably, the length measuring member 560 is integrated with the rear holding element 520 and thereby forming a one-piece article. According to one specific example, the length measuring member 560 is a ruler. In this embodiment, the scale of the ruler is designed to reflect the deformation level of the foreskin of the subject. For example, the scale may be set to indicate the distance between the respective free ends (550AE , 550BE) of the two extension members (550A, 550B) , which in turn, indicates the level of foreskin deformation caused by a pre-determined deformation grade.

In other optional embodiments, the measuring device 500 further comprises a pressure measuring unit 570, a calculation unit (not shown) and a display 580 (see, Figure 13A) . The pressure measuring unit 570 is disposed one the remote end 550BE of the extension member 550B and is configured to measure a pressure being applied on the foreskin of the subject and thereby generates a pressure signal. The pressure detecting unit 570 is made of at least one piezoelectric material. Specifically, the pressure measuring unit 570 is configured to be in contact with the foreskin of the subject, so that during use, the pressure applied on the stretched foreskin is sensed by the pressure measuring units 570, which in turn, generates the pressure signals (e.g. potential difference) in relation to the pressures being applied thereon.

The calculation unit is disposed within the display 580 and electrically coupled with the pressure measuring unit 570 and the display 580. The calculation unit is configured to process the pressure signal sent from the pressure measuring unit 570 and thereby generates a calculated value of the pressure signal to the display 580. The display 580 is disposed on the rear holding element 520 and is configured to display the calculated value of the pressure signal.

In another embodiment, the measuring device 500 may electrically connects to a computing device via wire or wireless network. In optional embodiments, the computing device is a personal computer (PC) , tablet PC, mobile phone, portable electronic, personal digital assistant (PDA) , etc.

In other optional embodiments, the wireless network is Infrared transmission, Bluetooth, WiFi, mobile communication technology (e.g. 3G or 4G) , etc.

Figures 14A and 14B are schematic drawings respectively illustrating the structures of the measuring device 500 in a non-operating condition and operating condition in accordance with various embodiments of the present disclosure.

For the sake of brevity, members that are similar to those of the measuring device 500 as depicted in Figures 13A and 13B are not discussed in this embodiment. It should be noted that the measuring device 600 of this embodiment is an electronic device. The measuring device 600 is different from the measuring device 500 described above in that the length measuring device 660 of the foreskin measuring device 600 is an optoelectronic device suitable for measuring the length changes of the stretched foreskin. For example, the length measuring device 660 may be an infrared or a laser-based measuring device.

Referring to Figure 14A and Figure 14B, the length measuring device 660 is disposed on the upper end 620U of the rear holding element 620 and electrically coupled to the calculation unit (not shown) and display 680. Specifically, the infrared measuring device is configured to send an infrared signal and receive a returned infrared signal reflected from the upper end 610U of the front holding element 610, and then generate a length signal based on the returned infrared signal. The length signal is used by the calculation unit to calculate a deformation value that corresponds to the foreskin deformation level of the subject. According to optional embodiments, the display 680 is configured to display the deformation value.

A further aspect of the present disclosure is to provide a method of measuring a pressure value, and a corresponding deformation level of the foreskin of a subject.

In general, the method comprises steps as follows. First, the two free ends of the extension members that are in closed conformation (650AE and 650BE, as illustrated in Figure 14A) of the measuring device 600 are inserted into the preputial opening of the subject. Then, the front and rear holding elements (610 and 620) are pressed toward each other so that the two free ends (650AE and 650BE) of the respective extension members (650A and 650B) start to move away from each other, so that the foreskin is stretch to hold the preputial opening of the subject in an open state (see, Figure 14B) . At the same time, the pressure value and the deformation level (i.e., the changes in length of the foreskin) are respectively detected by the pressure measuring unit 670 and the length measuring member 660 of the measuring device 600, thereby generating a deformation data. Then, some or all of the deformation data (or optionally, some or all of the deformation data processed by the calculation unit) are displayed on the display 680.

In another embodiment, the measuring device 600 disclosed herein may be used to facilitate the insertion of the foreskin shaping device described above into the preputial opening of the subject.

During the foreskin shaping procedure, any of the foreskin shaping device described above is first placed into the space (C) formed between the two extension members (650A, 650B) of the front and rear holding elements (610, 620) of the foreskin measuring device 600. Then, with the help of the foreskin measuring device 600, operated in accordance with the procedures as described above, so that the preputial opening of the subject is opened while the two extension members (650A, 650B) of the front and rear holding elements (610, 620) remain in open conformation, any of the foreskin shaping device may be pushed into the preputial opening of the subject and left there for a sufficient period of time to help shape the foreskin. Thereafter, the foreskin measuring device 600 is removed from the foreskin of the subject. In this case, the present foreskin measuring device 600 may be used as a measuring device, and a foreskin shaping device as well.

It will be understood that the above description of embodiments is given by way of example only and that various modifications may be made by those with ordinary skill in the art. The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the invention. Although various embodiments of the invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those with ordinary skill in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention.

Claims

A kit for shaping the foreskin of a subject, comprising a foreskin shaping device, an applicator, and a measuring device, wherein

the foreskin shaping device comprises an elongated body that is open at both ends, and at least one fluid channel therein；

the applicator comprises a base, and a plurality of fingers, wherein each finger is tapered at one end while the other end is coupled to the base, and the tapered ends of the plurality of fingers gather together to form a pointed tip, thereby defines a first space for receiving the foreskin shaping device therein； and

the measuring device comprises:

a cylindrical body having a front end and a rear end；

a sliding member, disposed within the cylindrical body and is configured to move along the longitudinal direction of the cylindrical body；

a tongue, disposed on the outer surface of the cylindrical body, and is configured to stretch the subject’s foreskin and hold the preputial opening in an open state；

a translating member, disposed within the cylindrical body and coupled with the sliding member and the tongue, wherein the translating member is configured to cause the tongue to move away from the outer surface of the cylindrical body when the sliding member moves toward the front end of the cylindrical body； and

a length measuring member, disposed on the sliding member for measuring the deformation level of the foreskin of the subject.
The kit of claim 1, wherein the measuring device further comprises:

a pressure measuring unit, disposed on the surface of the tongue and is configured to measure a pressure being applied on the foreskin of the subject and thereby generates a pressure signal；

a calculation unit, disposed within the sliding member and coupled with the pressure measuring unit, wherein the calculation unit is configured to process the pressure signal sent from the pressure measuring unit and thereby generates a calculated value of the pressure signal； and

a display unit, disposed on the surface of the sliding member and coupled with the calculation unit, wherein the display unit is configured to display the calculated value.
The kit of claim 1, wherein the length measuring member is a ruler.
The kit of claim 2, wherein the length measuring member is an optoelectronic device coupled to the calculation unit, wherein

the optoelectronic device is configured to measure a deformation level of the foreskin of the subject after the preputial opening of the foreskin being held opened by and tongue of the measuring device and thereby generates a length signal；

the calculation unit is configured to process the length signal sent from the optoelectronic device and generates a calculated value of the length signal； and

the display unit is configured to display the calculated value of the length signal.
The kit of claim 1, wherein the translation member is a multiple–compressed–fluid cylinder.
The kit of claim 1, wherein the translating member consists of multiple wedges.
The kit of claim 1, further comprising a plunger coupled with the base of the applicator, wherein the plunger is configured to move along the longitudinal direction of the applicator within the first space, so as to help inserting the foreskin shaping device into the preputial opening of the foreskin.
A kit for shaping the foreskin of a subject, comprising:

a foreskin shaping device, comprising an elongated body that is open at both ends and defines at least one fluid channel therein； and

an applicator comprising a base and a plurality of fingers, wherein each fingers is tapered at one end while the other end is coupled to the base, and the tapered ends of the plurality of fingers gather together to form a pointed tip and thereby defines a first space for receiving the foreskin shaping device therein.
The kit of claim 8, further comprising a plunger coupled with the base of the applicator, wherein the plunger is configured to move along the longitudinal direction of the applicator within the first space, so as to help inserting the foreskin shaping device into the preputial opening of the foreskin.
A measuring device for measuring the foreskin deformation level of the subject, comprising:

a cylindrical body having a front end and a rear end；

a sliding member, disposed within the cylindrical body member and is configured to move along the longitudinal direction of the cylindrical body；

a tongue, disposed on the outer surface of the cylindrical body and is configured to hold the foreskin of the subject open；

a translating member, disposed within the cylindrical body and coupled with the sliding member and the tongue, wherein the translating member is configured to cause the tongue to move away from the outer surface of the cylindrical body when the sliding member moves toward the front end of the cylindrical body； and

a length measuring member, disposed on the sliding member for measuring the deformation level of the foreskin of the subject.
The measuring device of claim 10, wherein the length measuring member further comprises:

a pressure measuring unit, disposed on the surface of the tongue and is configured to measure a pressure being applied on the foreskin of the subject and thereby generates a pressure signal；

a calculation unit, disposed within the sliding member and coupled with the pressure measuring unit, wherein the calculation unit is configured to process the pressure signal sent from the pressure measuring unit and thereby generates a calculated value of the pressure signal； and

a display unit, disposed on the surface of the sliding member and coupled with the calculation unit, wherein the display unit is configured to display the calculated value of the pressure signal.
The measuring device of claim 10, wherein the length measuring member is a ruler.
The measuring device of claim 10, wherein the length measuring member is an optoelectronic device that is coupled with the calculation unit, wherein

the optoelectronic device is configured to measure the deformation level of the foreskin of the subject and thereby generates a length signal；

the calculation unit is configured to process the length signal sent from the length measuring unit and thereby generates a calculated value of the length signal； and

the display unit is configured to display the calculated value of the length signal.
The measuring device of claim 10, further comprising a rod disposed within the sliding member with one end being projected out of the rear end of the sliding member.
The measuring device of claim 14, further comprising a deformation member disposed within the sliding member and coupled with the rod.
The measuring device of claim 15, wherein the deformation member is a spring.
The measuring device of claim 15, wherein the deformation member is a piezoelectric device.
The kit of claim 10, wherein the translating member is a compressed-fluid cylinder.
The kit of claim 10, wherein the translating member consists of multiple wedges.
A measuring device for opening the preputial opening or measuring the foreskin deformation level of a subject, comprising:

a pivot；

a front holding element having in its body, an upper end, a lower end, and an extension member extended from one side of the body of the front holding element, in which the lower end of the front holding element is coupled to the pivot；

a rear holding element having in its body, an upper end, a lower end, and an extension member extended from one side of the body of the rear holding element, in which the lower end of the rear holding element is coupled to the pivot；

a length measuring member coupled to the front or the rear holding elements and is configured to measure the foreskin deformation level of the subject； and

a pressure measuring unit disposed on either the first or the second extension member and is configured to measure a pressure being applied on the foreskin of the subject and thereby generates a pressure signal for determining the foreskin deformation level；

wherein,

when the respective upper ends of the front and rear holding elements are pressured to force them to come toward each other, the respective ends of the extension members of the front and rear elements are separated from each other by a distance, thereby can hold the preputial opening of the subject in an open state.
The measuring device of claim 20, further comprising:

a calculation unit disposed on the front or rear holding element and is coupled to the pressure measuring unit, wherein the calculation unit is configured to process the pressure signal sent from the pressure measuring unit and thereby generates a calculated value of the pressure signal； and

a display unit disposed on the front or rear holding element and is coupled to the pressure measuring unit, wherein the display unit is configured to display the calculated value of the pressure signal.
The measuring device of claim 20, wherein the length measuring element is a ruler.
A method for shaping a foreskin of a subject by use of the kit of claim 1, comprising:

placing the foreskin shaping device into the applicator so that it is disposed in the first space；

inserting the pointed tip of the applicator through the preputial opening of the foreskin of the subject； and

pushing the foreskin shaping device disposed in the first space out of the pointed tip formed by the tapered ends of the plurality of fingers of the applicator and into the foreskin of the subject.
The method of the claim 23, further comprising:

measuring the deformation level of the foreskin by use of the measuring device to generate a deformation data； and

customizing the foreskin shaping device to the subject based on the deformation data.