CN107669240B - Disposable dilator with lateral stabilizing 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 stabilizing mechanism

The application is a divisional application of a patent application with the filing date of 2012, 02/17, application number of 201210039204.7 and the title of "disposable dilator with lateral stabilizing mechanism".

Technical Field

The embodiments disclosed below relate to a dilator, and more particularly to a disposable vaginal dilator having lateral support and manipulation mechanisms.

Background

A dilator is a medical instrument used to dilate a body opening in medical examinations. Vaginal dilators are often used in gynecological examinations or surgical procedures to be inserted into a patient's vagina to separate the inner vaginal walls so that medical personnel can examine the internal genitalia. Traditionally, the duck bill dilator which is made of metal and can be sterilized at high temperature is used for gynecological examination or treatment. Such a device with exposed joints, sharp edges and a cold metal touch has been heretofore disliked by patients. The pivot joint of the dilator and the edge of the jaw often cause pinching, scratching, and even trauma to the supported vaginal tissue within the examined organ. Traditionally, the jaws of metal dilators are mostly semi-opaque, so when cervical examinations are performed, the only observable area is the area of the vaginal wall at the open end of the metal dilator and between the jaws.

To solve the above problems, plastic expanders have been developed. Plastic expanders are formed of plastic or other lightweight inexpensive materials and often have dual shafts. While the dual spindle design adequately supports the vertical stresses experienced by the dilator, the current design allows the dilator to move significantly when subjected to lateral forces. During surgery without anesthesia, lateral forces are often generated once the vaginal muscles are tensed. These lateral forces cause lateral movement of the dilator that is not readily appreciated by the physician, as this would cause the dilator to move within the vagina. In the worst case, damage to the dilator is caused.

Since typical dilators do not have built-in illumination means, whether there is sufficient light in the examined area is another problem. Light must be directed from an additional light source and the gooseneck light typically partially obstructs the view of the vagina. While the headband style flashlight partially solves this problem, it causes inconvenience and encumbrance for the surgeon to act on the light source circuit at once. If the light source is built in the handle of the dilator, the light is generally projected to the light guide pillar located at the center of the dilator. Because such a light source and light guide post occupy the center of the handle of the dilator, the spindle mechanism of the dilator must be offset to the side. However, the side effect of the offset from the center of the dilator is to create lateral stress and result in increased lateral motion.

Disclosure of Invention

Accordingly, at least one embodiment provides a dilator. The dilator of this embodiment may include an upper member, a lower member, and a linear support member. The upper member includes an upper jaw having an inner end and an outer end. The lower member includes a lower jaw having an inner end and an outer end. The lower jaw has a right side and a left side when viewed from the inner end of the lower jaw. The lower jaw comprises a support structure located at an inner end of the lower jaw. The support structure extends vertically onto the left or right side of the lower jaw. The lower member also includes a handle portion extending downwardly from the inner end of the lower jaw and defining an upright track. The 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 positioned 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 supporting groove is matched with the supporting structure of the lower jaw piece in a sliding way.

Drawings

The several embodiments disclosed herein are further explained by the accompanying drawings, wherein like elements are referred to by like numerals throughout the several views. The drawings disclosed are not necessarily to scale, but generally illustrate the principles of the disclosed embodiments.

Fig. 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 the upper member of the vaginal dilator of FIG. 1A;

FIG. 3 depicts a plan view of the inside of the upper member of the vaginal dilator of FIG. 2, the depicted upper member including an upper jaw plate, a support structure and an operating mechanism;

FIGS. 4A and 4B depict perspective views of the lower member of the vaginal dilator of FIG. 1A, with FIG. 4A depicting a rear perspective view of the lower member and FIG. 4B depicting a front perspective view of the lower member;

FIG. 5 depicts a close-up plan view of the lower member of the vaginal dilator of FIGS. 4A and 4B, the lower member including a lower jaw piece and a track for incorporation of a linear support member;

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

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

FIGS. 8A and 8B illustrate the upper member of FIGS. 1A and 1B secured to the linear support member of FIG. 7, FIG. 8A showing a side view of the upper jaw secured to the linear support member, and FIG. 8B showing a perspective view of the upper jaw secured to the linear support member;

FIG. 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;

FIGS. 10A, 10B, and 10C illustrate one embodiment of a light source suitable for use in the vaginal dilator illustrated in FIGS. 1A and 1B, FIG. 10A illustrates a perspective view of some of the inner and outer parts of the light source, FIG. 10B illustrates a back view of the inner parts of the light source, and FIG. 10C illustrates a side view of some of the outer parts of the light source;

FIG. 11 illustrates one embodiment of a light guide and smoke evacuation channel suitable for use with the vaginal dilator of FIGS. 1A and 1B equipped with the light source of FIG. 10A;

FIG. 12 depicts 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 element symbols ]

100: dilator

110: key hole

115: working space

120: upper member

122: upper jaw piece

125: rotating shaft module

126: gap

127: operating mechanism

128: supporting beam

129: parallel supporting beam

130: lower member

131: stopper

132: lower jaw piece

133: inner surface

134: handle part

135: concave part

136: support structure

136 a: long upright part

136 b: short horizontal part

137: vertical rail

138: light guide column

138 a: inner end

138 b: outer end of

138 c: air extraction channel

139: recess

150: supporting member

152: inner end

153: hole(s)

154: elongated body

155: lifting foot

156: outer end of

157: angle arm

158: lip part

159: latch

160: light source

163: outer casing

164: light emitting diode

165: insulating sheet switch

166: battery with a battery cell

169: opening of the container

191: support groove

Detailed Description

Vaginal dilators with laterally stable support and manipulation mechanisms are disclosed. The disclosed vaginal dilator is made of plastic material and is designed as a completely disposable single use item. It should be understood that although the disclosed vaginal dilator is for use by a gynecologist, other physicians such as an attending physician, an geriatric physician, a urologist, a medical care practitioner can also use the disclosed vaginal dilator.

The term "cross-infection" as used herein refers to the indirect infection of bacteria or viruses between patients through the use of improper disinfection procedures, unclean instruments or recyclates.

The term "disposable" as used herein means that the vaginal dilator of the present invention is designed for short term convenience and is intended primarily for single use. Therefore, the disposable vaginal dilator does not need to be sterilized after use, so that the maintenance cost of the vaginal dilator can be reduced, and the risk of cross infection can be minimized.

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

The term "gynecological examination" or "surgical procedure" as used herein refers to a medical procedure for viewing, examining and (/ or) removing a portion of a female internal genitalia from a female patient. General gynecological examination and surgical procedures include, but are not limited to, Colposcopy (Colposcopy), Cervical cryosurgery (Cervical cryosurgery), Cervical circular electrocision procedure (LEEP), Hysteroscopy (Hysterocopy), uterine dilatometry and curettage (D & C), Cervical biopsy (Cervical biopsyy), Cervical villus sampling (Cervical villus sampling; Cervical CVS), endometriectomy (Endometrial ablation), Endometrial biopsy (Endometrial biopsyy), Vaginal hysterectomy (Vaginal Hysteroscopy), and Cervical PAP (Cervical pasteurisation).

The disclosed vaginal dilator may be used in various medical procedures, particularly in gynecological procedures, whether in an office or hospital setting.

The term "lifting motion" as referred to herein refers to the vertical up and down motion of the upper jaw plate relative to the lower jaw plate of the vaginal dilator of the present invention.

The term "linear" as used herein refers to a linear line of material, such as: a linear strip of 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" as referred to herein refers to an upward and downward movement of the upper jaw plate relative to the lower jaw plate in an angular direction of the vaginal dilator of the present invention.

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

The term "open state" as used herein refers to a position in which there is an open space between the upper and lower jaws of the vaginal dilator of the present invention. This open position can be achieved by raising and lowering the support members which connect the upper and lower jaws together. Alternatively, the open position may be achieved by relative angular movement of the upper and lower jaws. Of course, the expanded state can also be achieved by combining the two methods.

The term "working space" as referred to herein refers to the space between the upper and lower jaws of the vaginal dilator of the present invention. In one embodiment, the working space is a space for viewing, examining and performing surgical procedures on female internal genitalia.

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

The term "fulcrum" as referred to herein refers to a support structure formed by the engagement of the support member with the support structure of the vaginal dilator of the present invention. The support structure is formed to allow angular movement of the upper jaw piece of the vaginal dilator relative to the lower jaw piece of the vaginal dilator.

As shown in fig. 1A and 1B, the disposable vaginal dilator 100 of the present invention comprises 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 engages the upper member 120 and the lower member 130, details of which will be described in detail below. Unlike metal dilators which are designed to be non-single use and sterilizable for reuse after each use, the entire dilator 100 of the presently disclosed embodiments is manufactured from one or more plastics or composite plastics, and the dilator 100 is sterilized only at the time of manufacture or packaging. The dilator 100 is inexpensive enough to be disposable. Sterilizing a repeatedly used dilator is not only time consuming but also cost consuming. More importantly, if not properly sterilized, blood-borne pathogens or other harmful biological agents in the patient can survive sterilization and be transmitted to other patients. Because the entire dilator 100 of the presently disclosed embodiments is disposable, the dilator 100 does not need to be sterilized after each use, which can greatly reduce the time and expense associated with sterilization procedures and can also prevent cross-contamination. Plastic materials that may be used to form the various components of dilator 100 include, but are not limited to, polypropylene (PP), polyester (polyester), Polyethylene (PE), acrylic (acrylic), polycarbonate (polycarbonate), Polyamide (PA), Polystyrene (PS), or any combination thereof. In one embodiment, the upper member 120 and the lower member 130 may be made of a substantially rigid and light conductive plastic material. For example, the upper member 120 and the lower member 130 may be molded from a clear plastic material, such as acrylic plastic or other similar materials. Acrylic is most suitable for use in the dilator 100 because it is relatively rigid, can be injection molded or extrusion molded, and has excellent light guiding properties. In one embodiment. The linear support member 150 is made of a different plastic material than the upper member 120 and the lower member 130. The linear support member 150 is made of a rigid yet strong plastic material. In addition, linear support member 150 may handle different load bearing modes as described in detail below. In one embodiment, the upper member 120 and the lower member 130 are made of polycarbonate (polycarbonate) material. In one embodiment, linear support member 150 is made of a polyester (polyester) material. In one embodiment, the linear support member 150 is made of a Polyamide (PA) material, such as: nylon (nylon).

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

As shown in fig. 2 and 3, the hinge module 125 includes a pair of parallel support beams 129 spaced apart from each other. The pair of parallel support beams 129 cooperate with the linear support member 150 to prevent the shaft from slipping when lateral forces occur. During use of the expander 100, when pressure is applied to the operating mechanism 127, the operating mechanism 127 and the angled arms 157 on the linear support member 150 will cooperate with one another such that a user of the expander 100 can move the upper jaw 122 at different angles. The operating mechanism 127 is formed with a notch 126, and the notch 126 allows the angular arm 157 of the linear support member 150 to pass through and snap. The upper jaw 122 has a certain thickness, width and curved shape. These features prevent the upper jaw 122 from being damaged by pressure or stress during, for example, gynecological procedures. In one embodiment, the upper jaw 122 has a rounded outer end.

Fig. 4A and 4B illustrate the lower member 130 of the dilator 100. The lower member 130 includes a lower jaw 132 and a handle portion 134. The handle portion 134 includes an upstanding track 137 and a pocket 139. The upright rail 137 is a moving rail on which the linear support member 150 performs an elevating movement. The cavity 139 is used to provide a space for the light source 160 to be embedded therein (see fig. 1A and 1B). In one embodiment, upright rails 137 are an indented structure on a single side of handle portion 134. A plurality of catches 131 are provided on the outer surface of the handle portion 134 and at the outer end positions of the upright rails 137. These stops 131 cooperate with the detents 159 (see fig. 7) on the lifting feet 155 of the linear support member 150 to maintain the expander 100 in an expanded state at various distances selected by the user. Since the recess 139 for receiving the light source is generally disposed at the center of the handle portion 134, the upright rail 137 of the linear support member 150 is desirably disposed at the left or right of the recess 139. This supportive upright rail 137 arrangement allows the transfer of positive vertical stresses to the upper member 120 into lateral forces. In a conventional dilator, the upper jaw piece will thus be moved laterally. Such lateral movement can not only cause discomfort to the patient, but can also result in structural damage to the dilator, thereby preventing the medical procedure from being performed smoothly. To eliminate this lateral movement, a novel support structure 136 is attached to the lower member 130, the support structure 136 extending slightly into the workspace 115. The support structure 136 can cooperate with support slots 191 in the support member 150 (see fig. 7) to substantially eliminate lateral movement. The support structure 136 is depicted as being located on the right side of the lower member 130. In one embodiment, the support structure 136 and the support channel 191 are both located on the right side of the dilator 100. In another embodiment, the support structure 136 and support channel 191 would be on both sides of the expander 100.

In the embodiment illustrated in fig. 4B, the handle portion 134 has at least one contoured surface such that a user of the dilator 100 can easily grasp the handle portion 134. The lower jaw 132 has a certain thickness, width and curved shape. These features prevent damage to the lower jaw 132 from stress or strain. In one embodiment, the lower jaw 132 has a rounded outer end.

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

Fig. 7, 8A, 8B, and 9 illustrate different perspectives of linear support member 150 of vaginal dilator 100. Linear support member 150 has an inner end 152, an outer end 156, and a T-shaped elongated body 154. The elongated body 154 is incorporated into the upright rail 137. In addition, additional lateral support of the expander 100 is provided by the incorporation of the support structure 136 into the support channel 191. The hole 153 of the linear support member 150 is combined with the hinge module 125 of the upper member 120. The keyholes 110 cooperate with the parallel support beams 129 of the hinge module 125 to prevent sliding and subsequent damage to the hinge due to lateral stresses. Both the angled arm 157 and the lifting foot 155 project beyond the lip 158 of the elongated body 154. The angle arm 157 is fastened to the notch 126 of the operating mechanism 127 of the hinge module 125 of the upper member 120 through and due to the latch on the angle arm 157. The latch 159 of the lifting foot 155 is latched to the stop 131 on the outer surface of the handle 134.

During a gynecological examination or surgical procedure, a performing medical professional may sometimes wish to illuminate the workspace 115 to positively inspect the workspace 115. Conventional dilators do not have built-in lighting devices. While newer expanders include a light source, such designs often suffer from unnecessary heat generation, considerable power consumption, the need to connect to a power source and project light in unnecessary directions. The power consumed needs to be supplied by connecting to an external power supply via wires, but this is not only burdensome for the physician, but also presents a potential risk to the patient as the light source is difficult to disinfect after each use, and therefore would be a source of cross-contamination. The unnecessary light can not only illuminate the working space, but also illuminate the doctor, and the doctor is disturbed in observation.

Many solutions to overcome the above disadvantages are also problematic in their own right. One known dilator includes a fiber optic bundle built into the dilator and an external light source. While this design overcomes the problems of heat generation and light directivity, the problem of cross-infection still remains. Another known expander discloses a bulb and a reflector built into the handle portion of the expander. While this design overcomes the problem of light directivity, the problems of heat generation and cross-infection still remain. Other expanders disclose battery-driven halogen light sources built into the handle portion. While this design overcomes the problem of cross-infection, the problems of light directivity and heat generation still remain.

Fig. 10A, 10B and 10C illustrate one embodiment of an in-built light source 160, the in-built light source 160 being located within the handle portion 134 of the disposable plastic dilator 100. The case 163 protects the internal battery 166, the Light Emitting Diode (LED) 164, and the insulation sheet switch 165. To illuminate, the user can remove the insulation sheet switch 165 to turn on the led 164. The leds 164 may produce any desired illumination level. For example, the impedance tab may be located on the built-in light source 160 for controlling the illumination of the light emitting diode 164. The led 164 has high power efficiency, consumes relatively low power, and has a long life. The heat generation problem can be solved because the power efficiency of the light emitting diodes is much better than known incandescent lamps or other laser related solutions. The led 164 has a high degree of directivity, and the emitted light is only distributed within 20 degrees of the upper and lower path. Such a narrow light path ensures that light will only be projected into the workspace and not directly into the physician's eye. The leds 164 are highly efficient and may 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 dilator 100 to an external power supply.

In one embodiment, the LEDs 164 are white LEDs.

In one embodiment, a single or multiple wavelength LED may be used as the light source instead of a white LED, thereby allowing the user to select a specific wavelength of light that is particularly suitable for the materials, chemicals, tissues or tools used in current or future gynecological procedures. Such that the material, chemical, tissue, or tool is particularly illuminated when projected by the light source, thereby assisting the surgeon in the ability to view and perform the procedure, as well as assisting in the alteration of material properties (e.g., epoxy hardening or activating certain other specific material properties), changing the life state of the tissue, or as a neutralizer for contamination.

In one embodiment, the light emitting diode 164 is a single wavelength light emitting diode.

In one embodiment, the light emitting diode 164 is a multi-wavelength light emitting diode.

FIG. 11 illustrates an embodiment of a light guide 138, the light guide 138 having an inner end 138a and an outer end 138 b. The light guide 138 extends from the outer end of the cavity 139 to the outer end of the lower jaw 132 on its inner surface 133 (see fig. 4A and 4B). The inner end 138a of the light guide 138 transmits light from the light source 160 through the light guide 138 and out the outer end 138b of the light guide 138. The light guide 138 is contoured to fit on the inner surface 133 of the lower jaw 132. The inner end 138a of the light pipe 138 may include a lens. The lens is coupled to a light source 160 housed in a cavity 139 of the handle portion 134.

Some gynecological treatments remove abnormal cells from the inside or outside of the cervix. Furthermore, certain gynaecological interventions use instruments that create smoke, which makes it difficult for medical practitioners to see the workspace during gynaecological interventions. Thus, gynecological treatments often use an external vacuum source. These external vacuum sources are cumbersome in gynecological procedures, difficult to handle, and can be a source of cross-contamination due to repeated use on many patients.

The existing expanders with light guide columns and smoke evacuation channels have built the light guide columns in the lower jaw and the smoke evacuation channels in the upper jaw. This configuration severely reduces the working space between the jaws for a vaginal or uterine procedure. In addition, the external suction tube must be connected to the upper jaw plate of the existing dilator, which makes the physician's workspace more complicated and hindered.

As shown in fig. 11, 4A and 12, the lower member 130 of the dilator 100 has an air-extracting channel 138c and a light guide 138. The pumping channel 138c and the light guide 138 are merged together and located in the recess 135 of the lower member 130 to form a compact structure. The combined pumping and guiding structure consists of a light guide column 138 and a pumping channel 138 c. The suction channel 138c is cut into the side of the light pipe 138 that contacts the lower jaw 132. The duct formed by the evacuation channel 138c is used as a passage for evacuating smoke. The close configuration of the pumping channel 138c in combination with the light guide 138 maximizes the working space of the dilator 100. In addition, the external suction tube may be connected to the opening 169 of the handle portion 134 of the extender 100 rather than to the upper jaw 122 of the extender 100. The connection of the external suction tube to the underside of the handle portion 134 will maintain the vaginal access area clear and unobstructed for convenient manipulation by the physician. Smoke is drawn from the outer end 138b of the light guide 138, through a suction channel 138c extending from below the light guide 138, and out 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 138, through the suction channel 138c extending from below the light guide 138, and out the bottom of the handle portion 134 of the dilator 100 to which the external suction tube is attached.

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

The ability of the expander 100 of the present invention to carry external forces is a result of the combination of the various elements of the expander 100, including but not limited to the pivot module 125, the geometry of the support beam 128 and parallel support beam 129, the geometry of the upper jaw 122 and lower jaw 132, the lateral support structure 136 and support channel 191, and the internal forces that depend between the various elements. In one embodiment, pressure applied to the actuator 127 during use will be transferred to the spindle module 125, the aperture 153 and down to the elongated body 154 of the linear support member 150. As shown in fig. 3 and 8A, the operating mechanism 127 is an extension of the hinge module 125. The operating mechanism 127 extends outwardly and downwardly at an angle. The extended design of the operating mechanism 127 imparts an asymmetric load to the plastic linear support member 150 and causes lateral movement of the outer end of the upper jaw 122. To avoid lateral movement of the outer end of upper jaw 122, the present invention incorporates the novel features of lateral support structure 136 and support channel 191. For example, the operating mechanism 127 can absorb a portion of the initial load applied to the dilator 100 by the user, such that the two support holes 153 of the linear support member 150 are subjected to asymmetric loads. These asymmetric loads exerted on the linear support member 150 will be directed downward and forward. The asymmetric forward load causes a lateral force on the elongated body 154 of the linear support member 150. This lateral force in known dilators can cause the elongate body of the linear support member to twist, and can also cause unnecessary movement of the jaws of the dilator or damage to the shaft. In this embodiment, the lateral support structure 136 and the support grooves 191 absorb the forward asymmetric external force and thus substantially eliminate twisting of the elongated body 154 of the linear support member 150. Since the torque applied to the linear supporting member 150 is reduced, the twisting tendency of the linear supporting member 150 is reduced, and the plastic linear supporting member 150 can be applied to the dilator 100.

During use of the dilator 100, for example: in gynecological procedures, dilator 100 is inserted into the patient's vagina. The vaginal wall then applies pressure or load to the upper jaw 122 and lower jaw 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 122 and the lower jaw 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 linear support member 150 and operating mechanism 127. This allows a sufficiently large bearing capacity in this relatively small area and prevents lateral movements of the upper jaw or damage to the pivot axis of the upper jaw.

The upper jaw 122 and the lower jaw 132 have a curved shape to increase the rigidity and strength of the jaws. The rigidity of the curved jaw allows the load to be supported over the entire length of the jaw without the need for additional reinforcing jaw structure. The inner end 152 of the linear support member 150 and the parallel support channel 191 and upstanding track 137 help to avoid damage to the expander 100 due to asymmetric loading on the jaws. Asymmetric loading on the jaws will cause the dilator 100 to twist relative to the axis of the handle portion 134, but the design of the dilator 100 avoids twisting.

When the dilator 100 of the present invention is operated during gynecological procedures, the upper jaw 122 and the lower jaw 132 are inserted into the vagina of a patient in a closed state. The closed state may refer to the upper jaw 122 and the lower jaw 132 being completely closed, or to the upper jaw 122 and the lower jaw 132 being partially closed. Then, by pressing the lifting foot 155, the linear support member 150 is moved upward up to a desired opening angle. The latch 159 of the lifting foot 155 is locked to the stopper 131 on the outer surface of the handle 134. In one embodiment, when the desired opening angle is reached, the operating mechanism 127 of the hinge module 125 will be pressed such that the upper jaw 122 is angularly separated from the lower jaw 132. The latch on the angle arm 157 snaps into the notch 126 of the hinge module 125 to maintain the expander 100 in the open position. The light source 160 may be illuminated to illuminate the surgical and examination site. Removing the insulating sheet switch 165 of the light source 160 can light up the light emitting diode 164. At the end of the treatment process, the insulator switch 165 may be inserted back to turn off the led 164. It should be understood that the disclosed dilator 100 may be manufactured in different sizes so that each patient can use the dilator 100 in the appropriate size. The dilator 100 may be manufactured using plastic materials of different strengths according to specific needs, as long as the dilator 100 is able to maintain structural integrity. For example, a routine PAP smear test (PAPAN _ SNonicolaou test) may use a lower strength dilator 100 than a dilator 100 used in a Vaginal hysterectomy (Vaginal hysterectomy).

In one embodiment, the expander 100 provides an adjustable upper jaw 122 and an adjustable lower jaw 132 to expand during use of the expander 100. Means of providing adjustable jaws include, but are not limited to, the use of laterally adjustable jaws capable of expanding the width of the jaws, as well as longitudinally adjustable jaws capable of expanding the length of the jaws. The adjustable jaws may be partially or fully received.

In one embodiment, the expander 100 provides a heating means for the upper jaw 122 or the lower jaw 132. Providing additional warmth by the heating device enhances patient comfort and also helps the patient relax the vaginal area. The heating means include, but are not limited to, the use of heating coils in the hollow region of the jaw and the use of chemical powders that oxidize in air in the hollow region of the jaw. In one embodiment, the expander 100 includes heating coils located in the upper jaw 122 and the lower jaw 132, thereby raising the temperature of the jaws to match body temperature. In one embodiment, the heating coil may be powered by a battery 166 used with the built-in light source 160. In one embodiment, the heating coil may be powered by a different battery.

In one embodiment, the extender 100 provides an end-mounted camera chip to capture real-time information and/or view medical procedures. The camera chip may store and capture information and be coupled to computer software to analyze the information. The information captured by the camera chip can be used to analyze labial, vaginal and cervical cells and to observe abnormalities.

In one embodiment, dilator 100 provides a pressure gauge whereby the pressure applied to the vagina from dilator 100 or to dilator 100 from the vagina is monitored, and the tightness of the vaginal cavity may also be monitored. The pressure gauge may be similar to the strain gauge or may be built into the expander 100 at the spindle module 125.

In one embodiment, the dilator 100 provides a hydrogen ion concentration index (pH) strip or pH meter, whereby the pH of the vagina can be rapidly and accurately measured. A pH dipstick or meter will be dipped into vaginal secretions to obtain pH at any point during the gynecological examination or surgery.

In an embodiment, the expander 100 provides a means including lubrication of either or both of the upper jaw 122 and the lower jaw 132. The lubricated jaws allow the dilator 100 to be more easily inserted into the interior of a patient's vagina 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 hollow areas for passage of lubricant and has lubricant release holes on the surface.

In one embodiment, the expander 100 packages a dose of lubricant in the hollow region of the jaw. The lubricant is released through the pores in the jaw surface, 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 may be attached. The syringe has a lubricant and replenishes the lubricant into the jaws through the external port.

A method of dilating a vagina includes providing a disposable vaginal dilator. The expander has an upper member, a lower member, and a linear support member. The upper member includes an upper jaw. The lower member includes a lower jaw and one or more lateral support beams. The support beam extends downward from the inside of the lower jaw. The linear support member connects the upper member and the lower member. The linear support structure engages the lateral support beams and engages the rotary actuator extending beyond the upper jaw and the linear support member extending from the lower member. The linear support member is vertically movable within an upright rail located on the side of the handle portion of the lower member. The method of dilating a vagina further comprises inserting the upper and lower jaws of the dilator into the vaginal opening and creating a working space between the upper and lower jaws, thereby dilating the vagina.

All patents, applications and publications cited herein are hereby incorporated by reference in their entirety. Several of the above-disclosed embodiments and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications.

Although the present invention has been described with reference to the above embodiments, it should be understood that various changes and modifications can be made therein by those skilled in the art without departing from the spirit and scope of the invention.

Claims (19)

1. A dilator, comprising:

an upper member including an upper jaw having an outer end and an inner end;

a lower member, comprising:

a lower jaw having an outer end and an inner end; and

a handle portion extending downwardly from the inner end of the lower jaw and defining an upright track, the lower member further including a support structure located at the inner end and extending vertically onto the right or left side of the lower jaw;

a linear support member having an inner end, an outer end and an elongated body, the inner end of the linear support member pivotally connected to the inner end of the upper jaw piece, the elongated body interposed between the inner end and the outer end of the linear support member;

wherein the elongated body of the linear support member slidably engages the upright track of the handle portion and the linear support member forms a support slot for the support structure to slide therein; and

an illumination assembly is connected to the lower member.

2. The expander according to claim 1, wherein the upper member, the lower member and the illumination assembly define a working space therebetween, the illumination assembly being configured to provide a light to the working space.

3. The expander according to claim 2, wherein the illumination assembly comprises a light source comprising a light emitting diode and at least one battery configured to provide a source of energy to the light emitting diode.

4. The expander according to claim 3, wherein the illumination assembly further comprises an insulating sheet switch separating the battery and the light emitting diode, the insulating sheet switch being removable, wherein when the insulating sheet switch is removed, the battery provides energy to the light emitting diode to illuminate the light emitting diode.

5. The dilator of claim 3, wherein the handle portion includes a cavity, and the light source is disposed in the cavity.

6. The dilator of claim 3, wherein the illumination assembly further comprises a housing partially enclosing the light source.

7. The expander according to claim 6, wherein a side of the housing facing the lower member is open so that the housing and a portion of the lower member encase and secure the battery.

8. The expander according to claim 7, wherein the lower member forms a cavity therein, the light source being disposed in the cavity such that the housing and the cavity form a cover to enclose the battery.

9. The dilator of claim 3, wherein the light source is disposed within the handle portion of the lower member.

10. The dilator of claim 9, further comprising a light guide disposed above the light source, the light guide configured to transmit the light from the light source to the working space between the upper and lower jaws.

11. The dilator of claim 10, wherein the light guide is disposed on the lower member.

12. The dilator of claim 11, wherein the handle portion of the lower member comprises a cavity, the light source being disposed in the cavity, wherein the light guide extends from an outer end of the cavity toward a portion of the mandible, the portion being located on an inner surface of the mandible.

13. The dilator according to any one of claims 10 to 12, wherein the lower member forms a recess, the light guide being located in the recess.

14. The dilator of claim 13, wherein the depression of the lower member and the light guide form a suction channel that exhausts at least one of smoke and debris from the working space.

15. The dilator of claim 14, wherein the handle portion includes an opening in communication with the suction channel, the opening adapted to receive an external suction tube.

16. The dilator of claim 14, wherein the light guide forms a cover for the suction channel.

17. The dilator of claim 16, wherein the handle portion includes an opening in communication with the suction channel, the opening adapted to receive an external suction tube.

18. The expander according to claim 1, wherein the upper member, the lower member and the linear support member are all made of a plastic material.

19. The dilator of claim 18, wherein the plastic material comprises polypropylene, polyester, polyethylene, acrylic, polycarbonate, polyamide, polystyrene, or any combination thereof.

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