CN103252015B - Disposable dilator with lateral stabilization mechanism - Google Patents

Abstract

The invention discloses an expander, which comprises an upper member, a lower member and a linear supporting member. The upper member includes an upper jaw. The lower member includes a lower jaw piece and a handle portion. The lower jaw comprises a support structure. The support structure is located at the inner end of the lower jaw and extends vertically onto the right or left side of the lower jaw. The handle portion extends downwardly from the lower jaw and defines an upright track. The linear support member has an inner end pivotally connected to the upper jaw, an outer end, and an elongated body between the inner and outer ends. The elongated body slidably engages the upright track of the handle portion. The linear support member is formed with a support groove. The supporting groove is matched with the supporting structure of the lower jaw piece in a sliding way.

Description

Disposable dilator with lateral stabilization mechanism

technical field

The embodiments disclosed below relate to a dilator, especially a disposable vaginal dilator with a lateral support and operating mechanism.

Background technique

A dilator is a medical device used to dilate openings in the body during medical tests. Vaginal dilators are often inserted into a patient's vagina during gynecological exams or surgery to separate the vaginal lining so medical staff can examine the internal genitalia. Traditionally, duckbill dilators made of metal and capable of high-temperature sterilization are used for gynecological examination or treatment. Such exposed joints, sharp edges, and cold metal feel have always been disgusted by patients. The pivot joints of the dilator and the edges of the jaws often cause pinching, scratching, or even trauma to the supported vaginal tissue in the examined organ. Traditionally, the jaws of metal dilators are mostly opaque, so when performing a cervical test, the only area that can be seen is at the open end of the metal dilator and the area of the vaginal wall between the jaws.

In order to solve the above problems, the industry has developed plastic dilators. Plastic dilators are formed from plastic or other lightweight, inexpensive materials and often have dual shafts. While the dual-pivot design adequately supports the vertical stress experienced by the expander, the existing design allows meaningful movement of the expander when subjected to lateral forces. During surgery without anesthesia, lateral forces are often produced when the vaginal muscles are tensed. Sideways movement of the dilator due to these lateral forces is never desirable to the physician as it would cause the dilator to move within the vagina. The worst case is damage to the dilator.

Adequate lighting in the area being examined is another challenge since typical dilators do not have built-in lighting. The light must be directed from an additional light source, and gooseneck lights often partially block the view of the vagina. Although the headband flashlight can partially solve this problem, it makes the surgeon's every move subject to the line of the light source, which is inconvenient and cumbersome. If the light source is built into the handle of the dilator, it will generally project light to the light guide rod located in the center of the dilator. Because such a light source and light guide column occupy the center of the handle of the dilator, the pivot mechanism of the dilator must be shifted to the side. However, a side effect of the offset from the center of the dilator is lateral stress and increased lateral motion.

Contents of the invention

Accordingly, at least one embodiment provides a dilator. The dilator of this embodiment may comprise an upper member, a lower member and a linear support member. The upper member includes a palate having an inner end and an outer end. The lower member includes a jaw piece having an inner end and an outer end. The jaw piece has a right side and a left side when viewed from the inner end of the jaw piece. The mandible contains a support structure located at the inner end of the mandible. The support structure extends vertically onto the left or right side of the mandible. The lower member also includes a handle portion extending downwardly from the inner end of the lower jaw and defining an upstanding track. A linear support member has an inner end, an outer end, and an elongated body. The inner end of the linear support member is pivotally connected to the inner end of the upper jaw. The elongated body is located between the inner end and the outer end. The elongated body of the linear support member slidably engages the upright track of the handle portion. The linear support member is formed with a support groove. The support grooves slide to fit the support structure of the lower jaw.

Description of drawings

Several embodiments disclosed in this application will be further explained through the accompanying drawings, wherein similar components in each view will be marked with similar reference numerals. The disclosed drawings are not necessarily to scale, but rather generally illustrate the principles of the disclosed embodiments.

1A and 1B illustrate a vaginal dilator according to an embodiment of the present invention, FIG. 1A is a perspective view of the vaginal dilator, and FIG. 1B is a rear view of the vaginal dilator;

Fig. 2 depicts a perspective view of an upper member of the vaginal dilator of Fig. 1A;

Fig. 3 depicts a plan view of the inner side of the upper member of the vaginal dilator of Fig. 2, the upper member shown includes a palate, a supporting structure and an operating mechanism;

4A and 4B are perspective views of the lower member of the vaginal dilator of FIG. 1A , FIG. 4A is a rear perspective view of the lower member, and FIG. 4B is a front perspective view of the lower member;

FIG. 5 is a close-up plan view of the lower member of the vaginal dilator of FIGS. 4A and 4B , the lower member including the mandible and the track for the assembly of the linear support member;

Fig. 6 depicts a close-up perspective view of the track of Fig. 5;

7 is a perspective view of a linear support member of the vaginal dilator of FIGS. 1A and 1B;

Figure 8A and Figure 8B show the upper member of Figure 1A and Figure 1B, fixed on the state of the linear support member in Figure 7, Figure 8A shows the side view of the upper jaw piece fixed on the linear support member, Figure 8B shows the upper jaw piece 3D views of fixed to linear support members;

9 depicts a rear perspective view of the linear support member of FIG. 7 positioned within the track of the lower member of FIG. 6;

Figure 10A, Figure 10B and Figure 10C illustrate a light source according to an embodiment, which is suitable for the vaginal dilator illustrated in Figure 1A and Figure 1B, Figure 10A illustrates a perspective view of some internal and external parts of the light source, and Figure 10B illustrates the interior of the light source The back view of the parts, Figure 10C shows a side view of some external parts of the light source;

Fig. 11 shows a light guide column and a smoke exhaust channel according to an embodiment, which is suitable for the vaginal dilator in Fig. 1A and Fig. 1B equipped with the light source in Fig. 10A;

12 is a rear perspective view of the lower member of the vaginal dilator of FIG. 1A equipped with the light source of FIG. 10A.

[Description of main component symbols]

100: dilator

110: key hole

115: Workspace

120: upper member

122: palate

125: shaft module

126: Gap

127: Operating mechanism

128: Support Beam

129: Parallel support beam

130: lower member

131: stopper

132: jaw piece

133: inner surface

134: Handle

135: Depression

136: Support structure

136a: Long erect part

136b: short horizontal section

137: Upright track

138: Light guide column

138a: inner end

138b: outer end

138c: suction channel

139: Dimple

150: support member

152: inner end

153: hole

154: long and narrow body

155: Lifting Foot

156: outer end

157: Angle arm

158: Lips

159: stuck teeth

160: light source

163: shell

164: LED

165: Insulation sheet switch

166: battery

169: opening

191: Support groove

detailed description

A vaginal dilator with a laterally stable support and operating mechanism is disclosed herein. The disclosed vaginal dilator is made of plastic material and is designed as a completely disposable single-use product. It should be appreciated that although the disclosed vaginal dilator is intended for use by gynecologists, others such as attending physicians, geriatricians, urologists, and nurse practitioners can also use the disclosed vaginal dilators.

The term "cross-infection" mentioned in this article refers to the indirect transmission of bacteria or viruses between patients due to the use of improper disinfection procedures, unclean equipment or recycled materials.

The word "disposable" mentioned in this article means that the vaginal dilator of the present invention is designed for short-term convenience, and is mainly for single use. Therefore, the disposable vaginal dilator does not need to be sterilized after use, which can reduce the maintenance cost of the vaginal dilator and minimize the risk of cross-infection.

The term "female internal genitalia" as used herein refers to the labia, vagina and cervix.

The term "gynecological examination" or "surgical operation" mentioned in this article refers to a medical procedure of observing, examining and/or removing part of the female internal genitalia of a female patient. General gynecological examination and surgical procedures include but not limited to Colposcopy, Cervical cryosurgery, Loop electrosurgical excision procedure (LEEP), Hysteroscopy ), dilation and curettage (D&C), cervical biopsy (Cervical biopsy), cervical villus sampling (Transcervical chorionic villus sampling; transcervical CVS), endometrial ablation (Endometrial ablation), uterine Endometrial biopsy (Endometrial biopsy), vaginal hysterectomy (Vaginal hysterectomy), and cervical Pap test (Papanicolaou test; PAP test).

The disclosed vaginal dilator can be used in various medical procedures, especially in gynecology, whether in an office or in a hospital facility.

The word "lifting movement" mentioned in this article refers to the vertical up and down movement of the upper jaw relative to the lower jaw of the vaginal dilator of the present invention.

The word "linear" mentioned in this article refers to a straight-line material, for example: a straight-line plastic material. A linear support member means that the support member of the present invention is made of a linear plastic material, and the linear plastic material does not have any curved shape or bending angle.

The term "angular movement" mentioned herein refers to the upward and downward movement of the upper jaw of the vaginal dilator relative to the lower jaw in an angular direction.

The term "lateral movement" mentioned herein refers to the lateral forward and backward movement of the upper jaw relative to the lower jaw of the vaginal dilator of the present invention.

The word "open state" mentioned in this article refers to the position where there is an open distance between the upper jaw piece and the lower jaw piece of the vaginal dilator of the present invention. This open position can be achieved by raising and lowering the support members connected together with the upper and lower jaws. Alternatively, the open state can also be achieved by relative angular movement of the upper and lower jaws. Of course, the open state can also be achieved by combining the above two methods.

The term "working space" mentioned herein refers to the space between the upper and lower jaws of the vaginal dilator of the present invention. In one embodiment, the workspace is a space used to observe, examine and perform surgical procedures on the female internal genitalia.

The term "structural integrity" as used herein refers to the characteristics provided by the vaginal dilators of the present invention before, during and after use. The upper and lower jaws of the dilator are designed to take loads and transfer these loads to the other elements of the dilator to maintain the structural integrity of the dilator.

The term "fulcrum" mentioned herein refers to the supporting structure formed by joining the supporting member and the supporting structure of the vaginal dilator of the present invention. The formed support structure allows the upper jaw of the vaginal dilator to move angularly relative to the lower jaw of the vaginal dilator.

As shown in FIG. 1A and FIG. 1B , the disposable vaginal dilator 100 of the present invention includes an upper member 120 , a linear support member 150 and a lower member 130 , wherein the lower member 130 has a built-in light source 160 . The linear support member 150 joins the upper member 120 and the lower member 130, the details of which will be described below. Unlike metal dilators that are not designed for single use and are sterilizable for reuse after each use, the entire dilator 100 of the presently disclosed embodiments is made of one or more plastics or composite plastics. As a result, the dilator 100 is only sterilized at the time of manufacture or packaging. The dilator 100 is cheap enough to be thrown away. Sterilizing reusable dilators is time consuming and costly. What's more, bloodborne pathogens or other harmful biological agents in patients can survive after disinfection and spread to other patients if disinfection is not done properly. Since the entire dilator 100 of the presently disclosed embodiment is disposable, the dilator 100 does not need to be sterilized after each use, which can greatly reduce the time and cost of the disinfection procedure and prevent cross-infection at the same time. Plastic materials that can be used to make various parts of the dilator 100 include but are not limited to polypropylene (polypropylene; PP), polyester (polyester), polyethylene (polyethylene; PE), acrylic plastic (acrylic), polycarbonate (polycarbonate) , polyamide (polyamide; PA), polystyrene (polystyrene; PS) or any combination of the above. In one embodiment, the upper member 120 and the lower member 130 can be made of a substantially rigid plastic material that can guide light. For example, the upper member 120 and the lower member 130 may be molded from a colorless and transparent plastic material, such as acrylic plastic or other similar materials. Acrylic plastic is most suitable for the dilator 100 because it is relatively rigid, can be injection molded or extruded, and has excellent light guiding properties. In one embodiment. The linear support member 150 is made of different plastic materials from the upper member 120 and the lower member 130 . The linear support member 150 is made of rigid and strong plastic material. In addition, the linear support member 150 can handle different loading modes as detailed below. In one embodiment, the upper member 120 and the lower member 130 are made of polycarbonate. In one embodiment, the linear support member 150 is made of polyester material. In one embodiment, the linear support member 150 is made of polyamide (PA) material, such as nylon (nylon).

As best shown in FIG. 2 , the disposable dilator 100 includes an upper member 120 having upper jaws 122 . One end of the upper jaw piece 122 has a shaft module 125 . The pivot module 125 receives the loads applied to the upper member 120 and the lower member 130 and transfers the loads to other components of the dilator 100, as described in detail below. The shaft module 125 includes an operating mechanism 127 . The operating mechanism 127 extends outward from the shaft module 125 . In the embodiment disclosed in the drawings, the operating mechanism 127 is located on the left side of the upper jaw piece 122 . In another embodiment, the operating mechanism 127 may be located on the right side of the upper jaw piece 122 . The unique design and low profile of the shaft module 125 allows the user of the dilator 100 to have a large, unobstructed field of view when viewing a patient during a gynecological procedure. In one embodiment, the operating mechanism 127 extends outwardly and downwardly from the upper jaw piece 122 at an angle. In addition, the workspace 115 created when the dilator 100 is in the expanded state (see FIG. 1B , the dilator 100 is not shown in a fully expanded state) provides the user of the dilator 100 with exceptional instrument mobility. . Known dilators often provide limited working space and limited visibility due to poor design of the shaft module.

As disclosed in FIGS. 2 and 3 , the hinge module 125 includes a pair of parallel support beams 129 spaced at a distance from each other. The pair of parallel support beams 129 cooperate with the linear support member 150 to prevent the shaft from sliding when lateral force occurs. During use of the dilator 100, when pressure is applied to the operating mechanism 127, the operating mechanism 127 and the angled arm 157 on the linear support member 150 will cooperate to allow the user of the dilator 100 to move the palate at different angles. Tablet 122. The operating mechanism 127 is formed with a notch 126, and the notch 126 allows the angled arm 157 of the linear support member 150 to pass through and snap in. The upper jaw piece 122 has a certain thickness, width and curved shape. These appearance features can prevent the palate 122 from being damaged due to pressure or stress during, for example, a gynecological clinic. In one embodiment, the upper jaw piece 122 has a rounded outer end.

4A and 4B illustrate the lower member 130 of the dilator 100 . The lower member 130 includes a lower jaw piece 132 and a handle portion 134 . The handle portion 134 includes an upright rail 137 and a recess 139 . The upright track 137 is a moving track for the linear support member 150 to move up and down. The cavity 139 is used to provide a location space for the built-in light source 160 (see FIG. 1A and FIG. 1B ). In one embodiment, the upright rail 137 is an indented structure located on one side of the handle portion 134 . There are a plurality of stoppers 131 on the outer surface of the handle portion 134 and at the outer end positions of the upright rails 137 . These stoppers 131 cooperate with the locking teeth 159 (see FIG. 7 ) on the elevating feet 155 of the linear support member 150 to maintain the dilator 100 in the open state at various distances selected by the user. Since the recess 139 for accommodating the light source is usually disposed at the center of the handle portion 134 , the upright track 137 of the linear support member 150 is ideally disposed on the left or right of the recess 139 . The provision of such supportive upright rails 137 allows for the transfer of normal vertical stresses on the upper member 120 into lateral forces. In conventional dilators, the palate would be moved laterally as a result. Such lateral movement not only causes discomfort to the patient, but may also cause structural damage to the dilator, preventing the medical procedure from being performed smoothly. To counteract this sideways movement, a novel support structure 136 is added to the lower member 130 , the support structure 136 protruding slightly into the workspace 115 . Support structure 136 may cooperate with support slot 191 in support member 150 (see FIG. 7 ) to substantially eliminate lateral movement. Support structure 136 is shown on the right side of lower member 130 . In one embodiment, both the support structure 136 and the support groove 191 are located on the right side of the dilator 100 . In another embodiment, the support structures 136 and support slots 191 would be located on both sides of the dilator 100 .

In the embodiment shown in FIG. 4B , the handle portion 134 has at least one contoured surface so that the user of the dilator 100 can easily hold the handle portion 134 . The lower jaw piece 132 has a certain thickness, width and curved shape. These exterior features prevent jaw piece 132 from being damaged due to pressure or stress. In one embodiment, the jaw piece 132 has a rounded outer end.

FIG. 5 depicts a close-up plan view of the inner surface 133 of the jaw piece 132 . The upright rail 137 is T-shaped, that is, the upright rail 137 has a long upright portion 136 a and a short horizontal portion 136 b, thereby accommodating the linear support member 150 . FIG. 6 shows a close-up perspective view of the vertical track 137 for the assembly of the linear support member 150 .

7 , 8A, 8B and 9 illustrate different views of the linear support member 150 of the vaginal dilator 100 . The linear support member 150 has an inner end 152 , an outer end 156 and a T-shaped elongated body 154 . Elongated body 154 is assembled into upright track 137 . In addition, the support structure 136 incorporated into the support slot 191 provides additional lateral support for the dilator 100 . The hole 153 of the linear support member 150 is combined with the shaft module 125 of the upper member 120 . The keyholes 110 cooperate with the parallel support beams 129 of the shaft module 125 to prevent the shaft from sliding and subsequent damage due to lateral stress. Both the angled arm 157 and the lift foot 155 project beyond the lip 158 of the elongated body 154 . The angle arm 157 passes through and is locked to the notch 126 of the operating mechanism 127 of the rotating shaft module 125 of the upper member 120 by the locking teeth on the angle arm 157 . The locking teeth 159 on the lifting feet 155 are fastened to the stopper 131 on the outer surface of the handle portion 134 .

During a gynecological exam or surgical procedure, the performing medical professional may sometimes wish to illuminate the workspace 115 in order to actually view the workspace 115 . Traditional dilators do not have built-in lighting. Although newer expanders do include light sources, this design often has issues with generating unnecessary heat, consuming considerable power, requiring a connection to a power source, and throwing light in unwanted directions. The power consumed needs to be supplied by wires connected to an external power supply, but this practice is not only very cumbersome for doctors, but also will be one of the sources of cross-infection because the light source is difficult to disinfect after each use First, there is a potential risk to patients. The light from unnecessary directions will not only shine on the working space, but also shine on the doctor, causing confusion for the doctor in observation.

Many of the solutions to overcome the aforementioned shortcomings are themselves problematic. One known dilator includes a fiber optic bundle built into the dilator and an external light source. Although this design overcomes the problems of heat generation and light directivity, the problem of cross-contamination still exists. Another known dilator discloses a bulb and reflector built into the handle of the dilator. Although this design overcomes the problem of light directivity, the problems of heat generation and cross-infection still exist. Other expanders expose a battery-operated halogen light source built into the handle portion. Although this design overcomes the problem of cross-infection, the problems of light directivity and heat generation still exist.

10A , 10B and 10C illustrate a built-in light source 160 in an embodiment, and the built-in light source 160 is located in the handle portion 134 of the disposable plastic dilator 100 . The casing 163 protects an internal battery 166 , a light emitting diode (Light Emitting Diode; LED) 164 and an insulating sheet switch 165 . When lighting is desired, the user can remove the insulating sheet switch 165 to light the LED 164 . LEDs 164 can produce any desired level of illumination. For example, an impedance adjustment sheet can be located on the built-in light source 160 to control the illuminance of the LED 164 . The LED 164 has high power efficiency, relatively low power consumption and long service life. Because the power efficiency of light-emitting diodes is much better than that of known incandescent lamps or other laser-related solutions, the problem of heat generation can be solved. The light emitting diode 164 is highly directional, and the light emitted by it will only be distributed within the range of 20 degrees up and down the path. This narrow light path ensures that the light is only projected into the workspace and not directly into the physician's eyes. LEDs 164 are highly efficient and can be powered by one or more lightweight internal batteries 166 . Because the light source 160 is built into the handle portion 134 of the disposable dilator 100, the problem of cross-contamination is eliminated. The built-in light source 160 also eliminates the need for bulky and potentially dangerous wires to electrically connect the expander 100 to an external power supply.

In one embodiment, the LED 164 is a white LED.

In one embodiment, a single-wavelength or multi-wavelength light-emitting diode can replace a white light-emitting diode as a light source, thereby allowing users to select a specific light wavelength, which is particularly suitable for current or future gynecological clinics. Material, chemical substance, tissue or tool. Such materials, chemicals, tissues, or tools will glow extraordinarily brightly when projected by a light source, thus assisting the physician's ability to observe and perform surgery, as well as assist in changing the properties of the material (e.g. epoxy hardening) or intensify some other specific material properties), change the life state of the tissue or act as a pollution neutralizer.

In one embodiment, the LED 164 is a single wavelength LED.

In one embodiment, the LED 164 is a multi-wavelength LED.

FIG. 11 shows a light guide rod 138 according to an embodiment. The light guide rod 138 has an inner end 138 a and an outer end 138 b. The light guiding rod 138 runs from the outer end of the recess 139 to the outer end of the lower jaw piece 132 on the inner surface 133 thereof (see FIGS. 4A and 4B ). The inner end 138 a of the light guiding rod 138 passes the light from the light source 160 through the light guiding rod 138 , and is guided out by the outer end 138 b of the light guiding rod 138 . The light guide bar 138 is contoured to be mounted on the inner surface 133 of the lower jaw piece 132 . The inner end 138a of the light guiding rod 138 may include a lens. The lens is coupled to a light source 160 housed in a recess 139 of the handle portion 134 .

Certain gynecological procedures remove abnormal cells from the inside or outside of the cervix. Additionally, some gynecological practices use instruments that create smoke, making it difficult for healthcare practitioners to see the workspace during gynecological practices. For this reason, gynecological practices often use an external vacuum source. These external vacuum sources are cumbersome in gynecological practice, difficult to manipulate, and a source of cross-infection due to repeated use on many patients.

In existing dilators with a light guide column and a smoke exhaust channel, the light guide column is built into the lower jaw piece, and the smoke exhaust channel is built into the upper jaw piece. This configuration severely reduces the working space between the two jaws for vaginal or uterine procedures. In addition, the external suction tube must be connected to the palate of the existing dilator, which complicates and obstructs the physician's workspace.

As shown in FIG. 11 , FIG. 4A and FIG. 12 , the lower member 130 of the dilator 100 has an air suction channel 138 c and a light guide rod 138 . The air extraction channel 138c and the light guide column 138 are combined together and located in the recessed portion 135 of the lower member 130 to form a compact structure. The combined structure of air extraction and light guide is composed of light guide rod 138 and air extraction channel 138c. The suction channel 138c cuts into the side where the light guide column 138 is in contact with the lower jaw piece 132 . The pipeline formed by the suction channel 138c is used as a channel for evacuating smoke. The compact structure formed by combining the suction channel 138c and the light guide column 138 maximizes the working space of the dilator 100 . In addition, an external suction tube may be connected to the opening 169 of the handle portion 134 of the dilator 100 instead of the palate 122 of the dilator 100 . The connection of the external suction tube to the lower part of the handle portion 134 will keep the vaginal entrance area clear and unobstructed, so as to facilitate the operation of the physician. Smoke is sucked in from the outer end 138b of the light guide rod 138, passes through the suction channel 138c extending from below the light guide rod 138, and is discharged from the bottom of the handle portion 134 of the dilator 100 to which the external suction tube is attached.

In one embodiment, debris will be drawn in from the outer end 138b of the light guide post 138, through the suction channel 138c extending from below the light guide post 138, and from the bottom of the handle portion 134 of the dilator 100 to which the external suction tube is attached. discharge.

In one embodiment, bodily fluid will be drawn in from the outer end 138b of the light guide post 138, through the suction channel 138c extending from below the light guide post 138, and from the bottom of the handle portion 134 of the dilator 100 to which the external suction tube is attached. discharge.

The ability of the expander 100 of the present invention to bear external force is the result of the combination of components of the expander 100, which includes but not limited to the geometry of the shaft module 125, the support beam 128 and the parallel support beam 129, the geometry of the upper jaw piece 122 and the lower jaw piece 132, The lateral support structure 136 and the support groove 191, as well as the internal force of mutual attachment between different components. In one embodiment, the pressure exerted on the operating mechanism 127 during use will be transferred to the shaft module 125 , the aperture 153 and down to the elongate body 154 of the linear support member 150 . As shown in FIG. 3 and FIG. 8A , the operating mechanism 127 is an extension of the shaft module 125 . The operating mechanism 127 extends outwardly and downwardly at an angle. The extended design of the operating mechanism 127 imparts an asymmetrical load to the plastic linear support member 150 and causes lateral movement of the outer end of the upper jaw piece 122 . To prevent lateral movement of the outer end of the palate 122, the present invention incorporates the novel features of lateral support structures 136 and support slots 191 . For example, the operating mechanism 127 can absorb part of the initial load applied to the dilator 100 by the user, so that the two support holes 153 of the linear support member 150 can bear an asymmetrical load. These asymmetric loads on the linear support members 150 will be directed downward and forward. The asymmetric forward load creates a lateral force on the elongate body 154 of the linear support member 150 . This lateral force can, in known dilators, cause distortion of the elongate body of the linear support member and possibly cause unnecessary movement of the dilator jaws or damage to the shaft. In this embodiment, the lateral support structure 136 and the support groove 191 absorb the forward asymmetric external force and thus substantially eliminate the twisting of the elongated body 154 of the linear support member 150 . Since the torsion force of the linear support member 150 is reduced, the distortion tendency of the linear support member 150 is reduced, and the plastic linear support member 150 can be applied on the dilator 100 .

During the use of the dilator 100, such as a gynecological procedure, the dilator 100 is inserted into the patient's vagina. The vaginal walls then apply pressure or load onto the upper and lower jaws 122, 132 of the dilator 100. Due to the unique design of the lateral support structure 136 of the lower member 130 of the expander 100 , the upper jaw piece 122 and the lower jaw piece 132 can transfer this load to the linear support member 150 and the operating mechanism 127 . Support structure 136 can support side loads and distribute vertical loads evenly down to linear support members 150 and operating mechanism 127 . This results in a sufficiently large load-bearing capacity in this relatively small area without lateral movement of the palate or damage to the axis of rotation of the palate.

The upper jaw piece 122 and the lower jaw piece 132 have a curved shape to increase the rigidity and strength of the jaw piece. The rigidity of the curved jaw allows the load to be supported over the entire length of the jaw without the need for additional reinforcement of the jaw structure. The inner ends 152 of the linear support members 150 and the mutually parallel support slots 191 and upstanding rails 137 help prevent damage to the expander 100 due to asymmetric loading on the jaws. Asymmetric loading on the jaws would cause the dilator 100 to twist about the axis of the handle portion 134, but the present dilator 100 is designed to avoid twisting.

When operating the dilator 100 of the present invention during gynecological diagnosis and treatment, the upper jaw piece 122 and the lower jaw piece 132 will be inserted into the patient's vagina in a closed state. The closed state may mean that the upper jaw 122 and the lower jaw 132 are completely closed, or that the upper jaw 122 and the lower jaw 132 are partially closed. Then, by pressing the lifting foot 155, the linear support member 150 is moved upward until a desired opening angle. The locking teeth 159 of the lifting feet 155 are fastened to the blocking member 131 on the outer surface of the handle portion 134 . In one embodiment, when the desired opening angle is reached, the operating mechanism 127 of the hinge module 125 will be pressed so that the upper jaw piece 122 and the lower jaw piece 132 are separated at an angle. The hooks on the angled arm 157 are fastened to the notch 126 of the shaft module 125 so that the dilator 100 is maintained at the open position. The light source 160 can be turned on to illuminate the scene of surgery and examination. Removing the insulating sheet switch 165 of the light source 160 enables the LED 164 to be turned on. At the end of the diagnosis and treatment process, the insulating sheet switch 165 can be inserted back again to turn off the light emitting diode 164 . It should be appreciated that the disclosed dilator 100 can be manufactured in different sizes so that each patient can use the appropriate size dilator 100 . As long as the dilator 100 maintains structural integrity, the dilator 100 can be manufactured using different strength plastic materials according to specific needs. For example, compared with the dilator 100 used in vaginal hysterectomy (Vaginal hysterectomy), routine Pap smear (Papanicolaou test; PAP test) can use the dilator 100 of lower strength.

In one embodiment, the dilator 100 provides an adjustable upper jaw 122 and an adjustable lower jaw 132 for expansion during use of the dilator 100 . Means for providing adjustable jaws include, but are not limited to, the use of laterally adjustable jaws capable of extending the width of the jaws, and longitudinally adjustable jaws capable of extending the length of the jaws. These adjustable jaws can be partially or fully stowed.

In one embodiment, the dilator 100 provides heating means for the upper jaw piece 122 or the lower jaw piece 132 . Additional warmth provided by the heating unit enhances patient comfort and helps the patient relax the vaginal area. Heating means include, but are not limited to, the use of heating coils in the hollow area of the jaws, and the use of chemical powders that oxidize in air in the hollow areas of the jaws. In one embodiment, the dilator 100 includes heating coils located on the upper jaw piece 122 and the lower jaw piece 132, thereby raising the temperature of the jaw pieces to match body temperature. In one embodiment, the heating coil can be powered by the battery 166 used by the built-in light source 160 . In one embodiment, the heating coil can be powered by a different battery.

In one embodiment, dilator 100 provides an end-mounted camera chip to capture real-time information and/or observe medical procedures. The camera chip can store and capture information and connect to computer software to analyze the information. The information captured by the camera chip can be used to analyze labia, vagina and cervical cells and observe abnormalities.

In one embodiment, the dilator 100 provides a pressure gauge, whereby the pressure applied from the dilator 100 to the vagina or from the vagina to the dilator 100 can be monitored, and the tightness of the vaginal canal can also be monitored. The pressure gauge can be similar to the strain gauge, or can be built in the dilator 100 and set at the shaft module 125 .

In one embodiment, the dilator 100 provides a hydrogen ion concentration index (pondus hydrogenii; pH) test paper or a pH value detector, so as to quickly and accurately measure the pH of the vagina. pH strips or a pH meter are dipped in vaginal fluid to obtain pH at any point during a gynecological exam or surgery.

In one embodiment, the dilator 100 provides a device that includes lubricating either or both of the upper jaw piece 122 and the lower jaw piece 132 . The lubricated jaws allow the dilator 100 to be inserted into the patient's vagina more easily and provide a moist working environment during gynecological or surgical procedures.

In one embodiment, the body of the upper jaw 122 and/or the lower jaw 132 has a hollow area as a channel for lubricant, and has lubricant release holes on the surface.

In one embodiment, the dilator 100 packs a dose of lubricant within the hollow area of the jaw. The lubricant is released through the holes in the surface of the jaws, for example by pressing a button on the handle portion 134 . In one embodiment, the dilator may include an external port to which a syringe can be attached. The syringe has lubricant and the lubricant is replenished into the jaws through the external port.

A method of dilating a vagina includes providing a disposable vaginal dilator. The dilator has an upper member, a lower member, and a linear support member. The upper member contains a palate. The lower member includes a lower jaw and one or more lateral support beams. A support beam extends downwardly from the inside of the mandible. Linear support members connect the upper and lower members. Such a linear support structure engages the lateral support beams and engages the rotary operating mechanism extending out of the upper jaw and the linear support member extending from the lower member. The linear support member is vertically movable in the upright rail located on one side of the handle portion of the lower member. The method of dilating the vagina also includes inserting the upper and lower jaws of the dilator into the opening of the vagina, and creating a working space between the upper and lower jaws, thereby dilating the vagina.

All patents and their applications and publications cited herein are hereby incorporated by reference in their entirety. The several above-disclosed embodiments and other features and functions, or alternatives thereof, can be optionally combined in many other different systems or applications.

Although the present invention has been disclosed above in terms of implementation, it is not intended to limit the present invention. Any skilled person can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the present invention The scope of protection should be based on the scope defined by the appended claims.

Claims (10)

1. a kind of expander, it is characterised in that include：

One upper member, comprising：

One conjunctivus, have an outer end inner with one；

One lower member, comprising：

One maxillaria, it is inner and have on the left of in the of one when when the inner from the maxillaria from and a right side with an outer end and one Side, the maxillaria include：

One supporting construction, the supporting construction are located at the inner of the maxillaria and extend perpendicularly to the right side of the maxillaria or be somebody's turn to do On left side；And

Leader portion, extended downwardly from the inner of the maxillaria, and define a upright track；And

One linear support component, there is an inner, outer end and an elongated bodies, the inner of the linear support component to be articulated in The inner of the conjunctivus, the elongated bodies are between the inner of the linear support component and the outer end；

Wherein, the elongated bodies of the linear support component are slidably engaged the upright track of the handle portion；And

Wherein, the linear support component is formed with a support slot, and the support slot is slidably matched the supporting construction of the maxillaria.

2. expander according to claim 1, it is characterised in that the upright track defined in the handle portion is arranged at pair Should the left side of maxillaria or the opposite side of the supporting construction on the right side of this.

3. expander according to claim 1, it is characterised in that the upper member also includes a rotary axis module, the rotating shaft mould Block is arranged at the inner of the conjunctivus, and it is lateral from the two opposite sides of the conjunctivus that the rotary axis module includes a pair of rotating shaft support beams Grow；And

Wherein, the outer end of the linear support component is pivotally connected formed with a pair of holes, the device to hole and is respectively cooperating with the rotary axis module Those rotating shaft support beams.

4. expander according to claim 3, it is characterised in that the rotary axis module of the upper member is also comprising an operation machine Structure, the operating mechanism outwardly and downwardly extend from the conjunctivus with one with the angle of the conjunctivus of the upper member.

5. expander according to claim 4, it is characterised in that the linear support component includes an angle arm, the angle Arm extends back from the elongated bodies and has latch, and wherein the operating mechanism of the rotary axis module, should formed with a breach The latch of the breach and the angle arm that angle arm extends into the operating mechanism is releasably joined to operating mechanism definition A part for the breach, the operating mechanism is fastened in the angle arm whereby.

6. expander according to claim 1, it is characterised in that the upright rail defined in the handle portion of the lower member The elongated bodies of road and the linear support component are T-shaped.

7. expander according to claim 1, it is characterised in that the handle portion of the lower member is formed with multiple system gears Part, those block pieces processed are formed down from an outer end of the upright track, and the linear support component includes a latch, the latch Downwardly and forwardly extended with an angle with the outer end of the linear support component, the latch releasably engages this in vertical direction One of those block pieces processed of handle portion, so as to fixing the linear support component.

8. expander according to claim 7, it is characterised in that the linear support component includes a lifting foot, the lifting From the outer end interval of the linear support component, the segment distance of elongated bodies one upwardly extends foot, and the lifting passes through a user's enough Press and move up the linear support component so that the latch of the linear support component releasably engages the handle portion Those block piece processed wherein another one.

9. expander according to claim 1, it is characterised in that the upper member, the lower member and the linear support component All it is made up of plastic material.

10. expander according to claim 1, it is characterised in that the handle portion of the lower member formed with a depression, and The expander also includes a light source, and the light source is arranged at the depression, and light optionally is incident upon into the conjunctivus with being somebody's turn to do Between maxillaria.