Patent Application
20250143560
Embodiments of the present disclosure relate generally to medical devices, and in particular instances, to gynecological medical devices and methods.
The female anatomy is comprised of many unique reproductive organs. Specifically, the internal reproductive organs are the vagina, cervix, uterus, fallopian tubes, and ovaries. These organs have many functions. They are used for childbirth, sexual intercourse, procreation, and menstruation. To remain functional, these organs must remain healthy. Reproductive health has its own challenges. Women must take special steps to keep their reproductive systems healthy, as there are many medical complications which can lead to the downfall of a woman's reproductive health.
Like any other system in the human body, the health of each organ of the female reproductive system is important for the entire system to properly function. There are a wide array of common reproductive health concerns for women, some of which being endometriosis, fibroids, cancer, ovarian cysts, and sexually transmitted diseases. A woman aged 21 and older should have annual physical exams, routine screenings and be evaluated if she believes she is suffering from complications related to her reproductive health. If these health concerns are not dealt with in a timely manner, they may cause pain, infertility, or death.
Many steps must be taken to maintain a healthy reproductive system. An important step in maintaining a healthy reproductive system in a woman is having regular visits to a gynecologist, a type of doctor whose practice is focused on dealing with the health of the female reproductive system. If a woman believes she is having issues with her reproductive system it is important for a medical professional to actually evaluate these organs. This process is called a pelvic exam.
A pelvic exam is a physical exam of the internal and external female pelvic organs. It is used for evaluation of the female productive organs and urinary tract. It is recommended that women 21 years old and older have an annual physical examination which includes a pelvic exam. Symptoms such as pain, heavy or abnormal bleeding, discharge, or incontinence are indications that a pelvic exam is necessary. Annual screening is important because some diseases or infections of the reproductive system may be asymptomatic. A pelvic exam may also be necessary if a woman has been sexually assaulted or to assess a woman's anatomy in preparation for a medical procedure.
The examination is performed in three steps. The first step is an external visual examination, next step is an internal visual examination using a speculum, which may include a pap smear, and the last step is an internal palpation examination. The external visual examination involves the gynecologist simply looking at the external reproductive organs with the naked eye. The internal visual exam with a speculum allows a gynecologist to view the vaginal walls and cervix. The speculum is placed inside the vaginal canal and expanded. This dilation puts the vagina and cervix in view. During this step a medical professional may also conduct a pap smear. During each step the gynecologist is looking for abnormalities such as lesions, ulcerations, discharge, or unusual growths. Internal palpation involves a medical professional palpating from inside the vagina and outside the lower abdomen. Specifically, the gynecologist is checking the condition of the uterus and ovaries.
The speculum is a necessary tool in a pelvic exam which allows for visualization of the cervix and vagina. The average length of a vaginal canal is three to four inches long. The vaginal tissue has elastic qualities which make the vagina easily collapsible, which makes the cervix and vagina very hard to view. The speculum is a tool used to retract the vaginal walls. The speculum does this by being inserted into the vagina then expanding. This retraction and expansion puts the vaginal walls and cervix in view for a medical professional.
There are many different speculum designs. They have a duck bill like shape with similar dimensions to the vagina. Speculums can have either one, two, or three blades for retraction. Speculums have different sizes for different sized women of different ages. Such speculums are made out of plastic or metal. Metal speculums are reusable and must be sterilized, while plastic speculums are disposable. Some speculums are outfitted with a light source.
The most common type of speculum is a bivalve speculum (shown in
Proper practices during the exam are an absolute necessity for patients to maintain their dignity and modesty. The gynecologist must obtain informed consent from the patient before the exam begins. Each part of the exam must be explained by the gynecologist to the patient before it is done. The patient is to be undressed only the minimum amount of time necessary to conduct the exam. These exams are conducted on sterile medical examination tables, preferably with foot supports. The patient is to be undressed from the waist down and covered with a sheet. Many exams include the presence of a chaperone, especially in the event that the medical provider is a male.
A pelvic exam may feel intrusive and uncomfortable for some women. A woman's vagina is considered a private place, one which may be reserved for intimacy. It is a part of her body, and hers alone. She has the right to say what does or does not happen there. Pelvic exams may feel intrusive and invasive. They may involve an unfamiliar person entering and touching a private area of one's body with inorganic tools. These exams involve cold metal or plastic instruments. They involve invasive poking and prodding of sensitive areas. The exams are uncomfortable, unfamiliar, awkward, and perhaps violating. Inherently, these exams elicit stress and anxiety in women. Although these exams are uncomfortable, they are necessary. Thus, a need exists for a tool which can be used to retract the vagina during pelvic exams without causing women a slew of negative emotions.
Current devices enable health providers to provide beneficial examinations to patients. Yet still further improvements in speculum systems and methods are desired. Embodiments of the present disclosure provide solutions to at least some of these outstanding needs.
An object of this specification is to disclose a tool that comfortably dilates a woman's vagina for a pelvic exam.
It is yet another object of this specification to disclose a tool that allows for viewing of the vagina and the cervix for medical evaluation and treatments. In one embodiment, the above objectives are met by disclosing a vaginal speculum used to maintain vaginal dilation comprising: a flute; and an expander. That apparatus could further include wherein said flute features a tunnel at a proximal end. That apparatus could further include wherein the tunnel comprises a sleeve which is a hollow cylinder made out of a film and wherein the film uses a lip and a plurality of spines to maintain its structure. In another embodiment, the above objectives are met by disclosing a tilting hoop vaginal speculum used to maintain vaginal dilation comprising: handle, a guide rod, at least one tilting hoop rotatably attached to the guide rod, and a driving mechanism disposed in the handle for tilting the hoop between a retracted configuration and a deployed configuration. That apparatus could further include wherein said driving mechanism is a rotary dial that is coupled to a foot of the hoop via two pistons that operate to push or pull the foot so that the hoop rotates between the two stated configurations.
Disclosed may also be a related method of dilating a vagina during a pelvic exam comprising: placing a speculum in a vagina via a flute or guide rod, expanding a tunnel via a thread or rotating a hoop disposed on the guide rod via a rotary dial until the hoop is in a deployed configuration, contracting the tunnel via the expander or rotating the hoop via the dial until the hoop is in a retracted configuration, and removing the speculum via the flute or else via the guide rod.
In one aspect, embodiments of the present disclosure encompass vaginal speculums and related methods that can be used to maintain vaginal dilation. Exemplary speculums can include a flute and an expander. A flute can be defined by a circular lip on a tip of a support rod and circular rings distributed along the length of the support rod. The circular lip may be foldable. An expander can be defined by a rod, and can operate to unfold a foldable circular lip, for expanding the rings to dilate the vaginal walls and for supporting the foldable circular lip of the flute in an expanded configuration. Circular rings can be distributed along a length of the expander so that the cervix can be viewed through and between the rings and the foldable circular lip in the expanded configuration. In some cases, the foldable circular lip and the circular rings are coaxial relative to each other when the foldable circular lip is folded and when the foldable circular lip is unfolded. In some cases, a flute features a tunnel (e.g. at a proximal end thereof). In some cases, a tunnel includes a sleeve which is a hollow cylinder made out of a film. In some cases, the film uses a lip (e.g. at the tip of the control rod) and a plurality of spines (e.g. of the rings) to maintain its structure. In some cases, spines can be in the shape of rings. In some cases, the entire speculum or a portion thereof can be lined with silicone. In some cases, a catch can be attached to the proximal end of the expander.
In another aspect, embodiments of the present disclosure encompass a tilting hoop vaginal speculum configured to maintain vaginal dilation. A tilting hoop vaginal speculum can include a handle, a guide rod, at least one tilting hoop rotatably attached to the guide rod, and a driving mechanism disposed in the handle for tilting the hoop between a retracted configuration and a deployed configuration. In some cases, the driving mechanism is a rotary dial that is coupled to a foot of the hoop via two pistons that operate to push or pull the foot so that the hoop rotates between the two stated configurations.
In another aspect, embodiments of the present disclosure encompass methods of dilating a vagina (e.g. for viewing a cervix) during a pelvic exam (e.g. by a gynecologist). Exemplary methods include placing a speculum in a vagina via a guide rod, expanding a tunnel via an expander or rotating (unfolding) a hoop disposed on the tip of the guide rod via a rotary dial until the hoop is in a deployed configuration. In some cases, this can be performed such that a grip of the guide rod is circumferentially spaced relative to a grip of the expander. In some cases, this can be performed such that circular spines are distributed along a length of the expander and along a length of the flute. In some cases, this can be performed such that circular spines are tangential to the expander. Methods can include viewing the cervix while the full-circular spines are supported by the expander and the guide rod and while the compressive force of the vaginal wall of the vagina are being counteracted, so that the cervix may be viewed via looking between the grips (e.g. of the expander and guide rod) and through at least one of the fill circular spines and an unfolded hoop. In some cases, methods can involve supporting the full-circular spines via the expander and the guide rod to counteract a compressive force of a vaginal wall of the vagina. Methods can also include contracting the tunnel via the expander or rotating the hoop via rotating the dial until the hoop is in a retracted configuration. In some cases, the hoop and the circular spines are coaxial relative to each other when the foldable hoop is folded and when the hoop is unfolded. Methods can also include removing the speculum via the flute or else via the guide rod. In some cases, an expander can attach to a lip of a tunnel via a catch during contraction. In some cases, a tunnel of the speculum can be illuminated with an internal light. In some cases, a tunnel can be given structural support by a flute, guide rod, expander, and/or a plurality spines (e.g. circular spines). In some cases, a tunnel can be fixed to a guide rod. In some cases, a dial can include detents. In some cases, the hoops can be illuminated with a guide light. In some cases, the hoops can be given structural support by guide rod. In some cases, a tunnel can be defined by the hoops. In some cases, a speculum can include a string that can operate to pull a flute along the length of the support rods after the rings (and/or foldable circular lip) have achieved an expanded configuration.
In another aspect, embodiments of the present disclosure encompass systems and methods for dilating a vagina of a patient during a pelvic exam. Exemplary systems may include a flute, a handle, and a ring collar. In some cases, a flute can include a first retracting rod, a second retracting rod, a first nesting rod, a second nesting rod, a proximal foldable ring, and a distal foldable ring. In some cases, a handle can include a first proximal coupling mechanism configured to releasably couple with the first retracting rod, a second proximal coupling mechanism configured to releasably couple with the first retracting rod, a first groove configured to at least partially receive the first nesting rod, a second groove configured to at least partially receive the second nesting rod, and a first gripping mechanism and a second gripping mechanism operable to engage the flute when the proximal and distal foldable rings are in a folded orientation. In some cases, the flute is configured to transition between an expanded state where the proximal and distal foldable rings are in an unfolded orientation and a collapsed state where the proximal and distal foldable rings are in a folded orientation. In some cases, the handle is configured to maintain the flute in the collapsed state when the first proximal coupling mechanism is coupled with the first retracting rod, the second proximal coupling mechanism is coupled with the second retracting rod, and the first and second gripping mechanisms are engaged with the flute. In some cases, the ring collar is configured to engage the flute when the flute is in the expanded state. According to some embodiments, the first proximal coupling mechanism includes a first proximal extrusion, the second proximal coupling mechanism includes a second proximal extrusion, the first retracting rod includes a first slot configured to engage the first proximal extrusion, and the second retracting rod includes a second slot configured to engage the second proximal extrusion. In some embodiments, the first gripping mechanism includes a first external gripping mechanism having a first distal barb configured to engage a first narrow portion of the distal foldable ring, a second distal barb configured to engage a second narrow portion of the distal foldable ring, a first proximal barb configured to engage a first narrow portion of the proximal foldable ring, and a second proximal barb configured to engage a second narrow portion of the proximal foldable ring. In some embodiments, the second gripping mechanism includes a second external gripping mechanism having a first distal barb configured to engage a third narrow portion of the distal foldable ring, a second distal barb configured to engage a fourth narrow portion of the distal foldable ring, a first proximal barb configured to engage a third narrow portion of the proximal foldable ring, and a second proximal barb configured to engage a fourth narrow portion of the proximal foldable ring. In some embodiments, the first gripping mechanism includes a first internal gripping mechanism configured to engage the first nesting rod and a second internal gripping mechanism configured to engage the second nesting rod. In some embodiments, the handle includes a slider mechanism operable to disengage the first proximal coupling mechanism from the first retracting rod and the second proximal coupling mechanism from the second retracting rod. In some embodiments, the distal foldable ring is engaged with the first retracting rod at a first engagement point, with the second retracting rod at a second engagement point, with the first nesting rod at a third engagement point, and with the second nesting rod at a fourth engagement point. In some embodiments, the first engagement point is disposed 180° opposite that of the second engagement point and the third engagement point is disposed 180° opposite that of the fourth engagement point. In some embodiments, the first retracting rod includes a first proximal prong, the second retracting rod includes a second proximal prong, the first nesting rod includes a third proximal prong, and the second nesting rod includes a fourth proximal prong. In some embodiments, the first and second proximal prongs are disposed proximal to the third and fourth proximal prongs when the flute is in the collapsed state. In some embodiments, the first retracting rod includes a first proximal prong, the second retracting rod includes a second proximal prong, the first nesting rod includes a third proximal prong, and the second nesting rod includes a fourth proximal prong. In some embodiments, the ring collar includes a first tab configured to engage a first slot of the first proximal prong, a second tab configured to engage a second slot of the second proximal prong, a third tab configured to engage a third slot of the third proximal prong, and a fourth tab configured to engage a fourth slot of the fourth proximal prong. In some embodiments, the ring collar includes a light source. In some embodiments, the flute includes at least one padding mechanism configured to engage an introitus of the patient.
In another aspect, embodiments of the present disclosure encompass systems and methods for dilating a vagina of a patient during a pelvic exam by a gynecologist. Exemplary methods may include engaging a handle with a flute when the flute is in an expanded state, where the flute includes a first retracting rod, a second retracting rod, a first nesting rod, a second nesting rod, a proximal foldable ring, and a distal foldable ring, and where the handle includes a first proximal coupling mechanism configured to releasably couple with the first retracting rod, a second proximal coupling mechanism configured to releasably couple with the first retracting rod, a first groove configured to at least partially receive the first nesting rod, a second groove configured to at least partially receive the second nesting rod, a first gripping mechanism and a second gripping mechanism operable to engage the flute when the proximal and distal foldable rings are in a folded orientation. Exemplary methods may also include transitioning the flute from the expanded state to the collapsed state, inserting the flute at least partially within the vagina of the patient while the flute is in the collapsed state, transitioning the flute from the collapsed state to the expanded state by disengaging the handle from the flute, and/or coupling a ring collar with the flute, where the ring collar operates to maintain the flute in the expanded orientation. In some cases, the flute is configured to transition between the expanded state where the proximal and distal foldable rings are in an unfolded orientation and the collapsed state where the proximal and distal foldable rings are in a folded orientation. In some cases, the handle is configured to maintain the flute in the collapsed state when the first proximal coupling mechanism is coupled with the first retracting rod, the second proximal coupling mechanism is coupled with the second retracting rod, and the first and second gripping mechanisms are engaged with the flute. In some cases, the ring collar is configured to engage the flute via the first and second retracting rods and the first and second nesting rods of the flute. According to some embodiments, the first proximal coupling mechanism includes a first proximal extrusion, the second proximal coupling mechanism includes a second proximal extrusion, the first retracting rod includes a first slot configured to engage the first proximal extrusion, and the second retracting rod includes a second slot configured to engage the second proximal extrusion. According to some embodiments, the first gripping mechanism includes a first external gripping mechanism having a first distal barb configured to engage a first narrow portion of the distal foldable ring, a second distal barb configured to engage a second narrow portion of the distal foldable ring, a first proximal barb configured to engage a first narrow portion of the proximal foldable ring, and a second proximal barb configured to engage a second narrow portion of the proximal foldable ring. According to some embodiments, the second gripping mechanism includes a second external gripping mechanism having a first distal barb configured to engage a third narrow portion of the distal foldable ring, a second distal barb configured to engage a fourth narrow portion of the distal foldable ring, a first proximal barb configured to engage a third narrow portion of the proximal foldable ring, and a second proximal barb configured to engage a fourth narrow portion of the proximal foldable ring. According to some embodiments, the first gripping mechanism includes a first internal gripping mechanism configured to engage the first nesting rod and a second internal gripping mechanism configured to engage the second nesting rod. According to some embodiments, the handle includes a slider mechanism operable to disengage the first proximal coupling mechanism from the first retracting rod and the second proximal coupling mechanism from the second retracting rod. According to some embodiments, the distal foldable ring is engaged with the first retracting rod at a first engagement point, with the second retracting rod at a second engagement point, with the first nesting rod at a third engagement point, and with the second nesting rod at a fourth engagement point. In some cases, the first engagement point is disposed 180° opposite that of the second engagement point and the third engagement point is disposed 180° opposite that of the fourth engagement point. According to some embodiments, the first retracting rod includes a first proximal prong, the second retracting rod includes a second proximal prong, the first nesting rod includes a third proximal prong, and the second nesting rod includes a fourth proximal prong. In some cases, the first and second proximal prongs are disposed proximal to the third and fourth proximal prongs when the flute is in the collapsed state. According to some embodiments, the first retracting rod includes a first proximal prong, the second retracting rod includes a second proximal prong, the first nesting rod includes a third proximal prong, and the second nesting rod includes a fourth proximal prong. In some cases, the ring collar includes a first tab configured to engage a first slot of the first proximal prong, a second tab configured to engage a second slot of the second proximal prong, a third tab configured to engage a third slot of the third proximal prong, and a fourth tab configured to engage a fourth slot of the fourth proximal prong. According to some embodiments, the ring collar includes a light source.
Other objectives of the disclosure will become apparent to those skilled in the art once the disclosure has been shown and described. These objectives are not to be construed as limitations of applicant's disclosure, but are merely aimed to suggest some of the many benefits that may be realized by the apparatus of the present application and with its many embodiments.
Inventive features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
It is to be noted that the appended figures illustrate only exemplary embodiments of this disclosure and are therefore not to be considered limiting of its scope, for the disclosure may admit to other equally effective embodiments that will be appreciated by those reasonably skilled in the relevant arts. Also, figures are not necessarily made to scale but are representative.
Specific embodiments of the disclosed devices, systems and methods of use will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to embodiments of the disclosure.
Disclosed are speculum embodiments and related methods to comfortably dilate a woman's vaginal canal during a pelvic exam. The details of exemplary embodiment are described with relevance to the figures.
Embodiments of the present disclosure encompass single-use vaginal speculum systems and methods that can be used for women's health exams. Exemplary devices can operate to create circumferential retraction of the vaginal tissue preventing or inhibiting vaginal prolapse. In some embodiments, exemplary devices can allow for enhances visualization of the vaginal canal, improving ease of use and exam efficiency. Additionally, exemplary devices can be used easily with one hand while allowing the other hand to perform with other necessary or desired procedural instruments.
In exemplary embodiments, a speculum can include a series of collapsible spiral rings that are fitted onto a tract of a slim elongated handle. The tract can be manipulated with a lever or other actuation mechanism to let the rings compress or decompress. In addition, a final ring collar can operate to enhance the speculum's stiffness to withstand tissue wall pressure. The ring collar can be provided with various options, including a single-use version with no LED lights and reusable version with LED lighting. The lighting can operate to improve visualization of the vaginal canal. The speculum can include two or more over molded rods to efficiently enable insertion and removal procedures.
In
The tunnel 11 and the spines 5 of which it is comprised, as shown in
The expander 7 is a tool which may be used to place and move the tunnel 11. The expander 7 may be comprised of a catch 3, a neck 10, and a grip 2. Like the flute 8, the grip of the expander 2 is preferably an ellipsoid, and the neck of the expander 10 may be a thin rod. The catch 3 is on the proximal end of the expander. The catch 3 may be configured to hook the lip 4 of the flute 8 to manipulate the tunnel 11.
Other embodiments of the speculum 12 may be constructed from different materials or composites. However, a preferred embodiment of the speculum 12 can be constructed out of silicone. The speculum 12 may be made out of plastic or metal and lined with silicone.
In one embodiment the tunnel has three positions, each having functional significance. These positions or states are “contracted” which is shown in
In Step E outlined by the flow chart in
Still referring to
The gynecologist is now able to observe the cervix 14 and the vaginal walls. Referring to
A flow of a pelvic exam follows the same steps as the exam described below. The speculum 20 is to be used during a pelvic exam to allow a medical provider or gynecologist the ability to view the vaginal walls and cervix. The exam begins by first having a patient disrobe. If the gynecologist is a male, a chaperone should be present. The patient is disrobed from the waist down and wrapped in a gown. Next, the patient will lie on their back on an exam table with their feet placed in stirrups. The patient slides to the end of the table and lets their knees open. Consent is obtained and the medical provider outlines each step of the process before the examination beings. At this point, the gynecologist may begin the external visual exam looking at the vulva for irritation, redness, or other abnormalities. Next, the gynecologist will use the speculum 20 of the specification to dilate the vaginal walls.
More specifically, the speculum 20 is inundated in a lubricant and warmed. At this point, the handle 23 is held in front of the vagina (not shown) by the hands of the gynecologist, with the handle 23 in one hand. The tunnel is in a retracted position. The hoop of the tunnel and the plurality of hoops 25 are facing upward. The hoops are stacked on top of guide rod 21.
The gynecologist will then instruct the patient to relax their muscles. Then the gynecologist places the guide rod 21 into the vagina (not shown) via the handle 23 to a necessary depth. The dial 24 is then rotated so that the hoops 25 rotate. The hopes 25 are rotated until they faces the cervix. The dial may suitably feature detents to lock the speculum in a deployed state. The tunnel of hoops 25 is now fully expanded. The tunnel of hoops 25 in its now expanded state provides structural support against the vaginal canal keeping the vagina (not shown) dilated.
The gynecologist is now able to observe the cervix and the vaginal walls. If a pap test is deemed necessary the gynecologist will take a sample of cervical cells. Lastly, the gynecologist will palpate the vaginal canal in an attempt to feel for similar abnormalities. During palpation the doctor will also feel the abdomen and pelvis since some organs like the uterus and ovaries cannot be seen. Then the speculum 20 is ready to be contracted. First the gynecologist uses the rotary dial to rotate the hoops of the tunnel to a retracted position. The sleeve 6 is retracted and the hoops 25 sit next to flat along the guide rod 21. The guide rod 21 is then pulled out of the vagina (not shown) via the handle 23. The examination is over. Lastly, the patient may sit up, get off the exam table, and clothe themselves.
Speculum embodiments disclosed herein can be provided as a collapsible device configured with rings connected with multiple (e.g. four) rods. In some cases, of the four rods, two can be over molded with plastic to enhance insertion and removal procedures. In some cases, one or more rods can have slots or engagement mechanisms to connect with the slim elongated handle and the ring collar. In some cases, the slim elongated handle allows for the collapsed speculum to be inserted into the vaginal canal and the ring collar can keep the speculum in its expanded position. Aspects of a speculum can be configured to vary in length, cross-sectional area, and diameter. In some cases, speculums may vary in the number and size of rings and/or rods they include. In some cases, a speculum or component thereof may include a light feature to enhance visualization. In some cases, a speculum or component thereof may feature different or desired geometries to enhance light distribution. In some cases, one or more components of a speculum can be made or include biocompatible rigid polymers and/or rubbers. In exemplary embodiments, speculums disclosed herein have no handle feature that would interfere with a patient's bottom. In some cases, exemplary speculum configurations can provide a 360-degree opening view. In some cases, exemplary speculum configurations can be used in any direction circumferentially. In some cases, exemplary speculum configurations are malleable to adjust naturally with vaginal wall pressure. In some cases, exemplary speculum configurations can be used with one hand. Embodiments of the present disclosure encompass speculum configurations that enable the end user to insert the device in a linear motion into the vaginal canal without any interference with residing anatomy. Exemplary devices can operate to expand to contour around the vaginal canal pressure, allowing for natural adjustability. In exemplary embodiments, one or more components of a speculum device can be made of or include rubber to improve comfort. A ring core or collar can be added to the end to keep the device expanded enough to allow for view of the cervix. In some cases, a ring core or collar can include one or more LED lights to allow for enhanced visualization. Exemplary ring collars can operate to allow for the device to remain in the vaginal canal so the user's hands are free to use for other instruments and procedures. The ring collar can then be removed so the speculum can be compressed for removal. In exemplary embodiments, a speculum can be provided as a multi-material, single-use vaginal speculum that contains geometry that allows for radial expansion of the vaginal canal to enhance viewing and ease of vaginal exams. Speculum configurations or components thereof can be provided in any of a variety of sizes, materials, and/or colors. Insertion handle geometries can be provided in a wide variety of configurations. Flute embodiments can include any desired number of rods and/or rings.
With returning reference to
The handle 200 can include one or more extrusions or other connection mechanisms by which one or more rods of the flute 300 can be mechanically coupled with the handle 200. For example, handle 200 can include one or more proximal extrusions 202, 204 as depicted in
With the prong slots 321A, 325A and corresponding handle proximal extrusions 202, 204 engaged with one another, the handle 200 can be retracted proximally relative to the flute 300 as indicated by arrow A, thereby drawing prongs 321 and 325 of the flute in a relatively proximal direction as well. As a result, the rings 312, 314, 316, 318 of the flute become folded, as rod 322 and the rod laterally opposed from rod 322 (hidden from view, rod 326) are pulled proximally relative to rods 324 and 328, as shown in
With reference to
Once the external gripping mechanisms have been engaged with the rings, the handle effectively operates to hold the rings in the folded orientation, and thus the flute is maintained in a low profile, contracted, or constrained configuration (e.g. as shown in
As shown in
As shown in
As shown in
As shown in
As shown in
With reference to
The handle 1000 can include one or more extrusions or other connection mechanisms by which one or more rods of the flute 300 can be mechanically coupled with the handle 1000. For example, handle 1000 can include one or more proximal extrusions (e.g. 1202 as depicted in
With the prong slots 321A, 325A and corresponding handle proximal extrusions 1202, 1204 engaged with one another, the handle 1000 can be retracted proximally relative to the flute 300, thereby drawing prongs 321 and 325 of the flute in a relatively proximal direction as well. As a result, the rings 312, 314, 316, 318 of the flute become folded, as rod 322 and the rod 326 (which is laterally opposed from rod 322) are pulled proximally relative to rods 324 and 328, as shown in
With returning reference to
After handle 1000 is moved in a proximal direction relative to the flute (which also moves rod 322 in the proximal direction), internal gripping mechanisms 1251, 1252, 1253, 1254 can be engaged with corresponding engagement mechanisms such as apertures or the like (not shown) of nesting rod 324. Likewise, internal gripping mechanisms on the opposing side of handle 1000 can be engaged with engagement mechanisms on nesting rod 328. Hence, it can be understood that handle 1000 can include grooves or recesses that are configured to accept or engage nesting rods when the rings are folded. For example, as rings are folded when handle 1000 is drawn proximally, nesting rod 324 can be positioned at least partially within groove 1201.
Once the internal gripping mechanisms have been engaged with the rods, the handle effectively operates to hold the rings in the folded orientation, and thus the flute is maintained in a low profile, contracted, or constrained configuration (e.g. as shown in
In at least one aspect,
The introducer 2100 shown in
Prong 2223 of rod 2224 is shown with a bump or other raised surface 2227 that is provided to allow leverage against providers finger to use, for example, when collapsing the device back down to remove the speculum. The bump 2227 is generally created out of the same material as the speculum, for example, silicone, and can be provided on any of prongs 2221, 2223, or 2225, or on multiple prongs.
In one exemplary method of insertion, the speculum 2200 and introducer 2100 are coupled together to collapse or expand the speculum 2200. In one exemplary aspect, the speculum and be placed onto an introducer during manufacturer. For example, if the flute/speculum is placed on an introducer during manufacture, the joint connections of both the posterior and the anterior arms of the flute, which maintain the support rods are settled along the introducer at the pedal points. The posterior arm of speculum slide onto the saddle/landing on the posterior side of the introducer until snug. Traction/pulling back in the distal direction on the arm of the anterior speculum with a support rod allows for the notch in this arm to be settled on the anterior prong of introducer. This closes the speculum along the introducer both anterior and posterior. Similarly, traction on the bilateral side arms of speculum again in the distal direction allow them to be attached on the introducer where the side prongs of introducer and the notches of the side arms meet will hold the device in the closed position. In this exemplary arrangement, the speculum in the closed position then has a grip at the distal end of introducer which helps guide the proximal end of closed speculum into a vagina in an upward or inward direction. The insertion continues generally until the introitus pads on flute are at the opening of vagina.
The provider (or patient optionally) then gently presses these pads together from the sides and lifts the anterior speculum arm off the prong freeing it from collapsed position anteriorly. Then each side arm of speculum is gently pressed out and off of the side prongs of introducer. Introducer is then grasped at grip location and pulled back/away from patient and removed from saddle. The introducer is no longer needed for duration of exam and can be discarded appropriately. The speculum then naturally expands out. If equipped or otherwise elected, the collar can be swiveled, hinged, or otherwise disposed into the position shown in
The exemplary light 2800 is generally configured of a similar shape to collar 2950 and can be attached thereto either when the exemplary collar 2950 is disposed in the collapsed or expanded positions. The light 2800 includes a light structure 2808 and can include tabs or grasps 2802 and 2804 that extend off the light structure 2808 to allow the light 2800 to rest upon, hang, cling, or be affixed to the speculum, the collar, or the speculum and collar when connected as a unit. The grasps 2802 and 2804 can be formed solitary or can be disposed in multiple locations about the light 2800. The light 2800 includes a light computer 2806 provides technical informatics for light functioning on the light structure. The light computer 2806 can be disposed anywhere along the light structure 2808 and, optionally, can include a battery compartment or other power supply. Further, the light computer 2806 can include a switch 2814 provided to turn the light on/off. The switch 2814 can be a single switch or could be multiple switches and can provide options, such as to allow for color changes (e.g., white, green, yellow, etc.) and can allow for various levels of brightness. The structure 2808 is generally a case or covering that provides shape and support to the light components, such as wiring, battery, bulbs, etc. The structure 2808 maintains form and can be flat or rounded, partially circular, or entirely circular in form. The structure 2808 can provide a light charging location, optionally, as shown at 2812, which can be singular or provided in multiple locations along the structure 2808. The light charging location 2812 supports charging the light 2800 and allows for electrical charge of the lighting unit.
The light 2800 can include one or more lights 2810, which can be light-emitting diodes (LEDs), incandescent, ultraviolet, or other type of light. The lights 2810 can be singular or provided in multiple locations along or within the light structure 2808. The lights 2810 can be provided in various colors, such as, for example, white, yellow, orange, green, purple, red, blue, or other colors, can be provided with a filter or filters, and can be provided to rotate through various colors as desired. The lights 2810 can be situated to allow for light to be cast out of the structure 2808 and, when connected to a speculum/collar, will cast light through the lumen or down the arms of the speculum structure for improved visualization through the speculum and/or collar, in a vagina, or the surrounds thereof. Further, the lights 2810 can be arranged to increase or decrease in illumination as the examination proceeds. Even further, the lights 2810 can strobe, flash, or otherwise be provided to illuminate various or specific portions of the speculum, especially when the speculum is disposed in the expanded configuration. Even further still, the light 2800 can be removed from the speculum before being collapsed or can be arranged to remain attached to the collar 2950 and hinged or otherwise removed from the locked position before the speculum is collapsed for removal from a vagina.
The speculum(s) detailed herein can include a light source that is either integral, an attachment, an additional piece, or otherwise functional to provide light inside the elements of the speculum, including the rings, along the speculum, adjacent the speculum, or cast into the vagina via or in operation with the speculum. The light source can be filtered, bright, soft, or provided in different colors. For example, the light can be a green filtered light, a blue light, a yellow light, a white light, or combinations of these or other colors. Further, the light can travel along and inside the elements of the speculum(s) and can illuminate a region within the speculum, adjacent the speculum, proximate an opening of the vagina, or distal the opening of the vagina. Further still, the light source can be an LED, infrared, ultraviolet light, or other type of light.
Although the methods and apparatuses are described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead might be applied, alone or in various combinations, to one or more of the other embodiments of the disclosed method and apparatus, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the claimed disclosure should not be limited by any of the above-described embodiments.
Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open-ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like, the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof, the terms “a” or “an” should be read as meaning “at least one,” “one or more,” or the like, and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that might be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.
The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases might be absent. Any use of the term “assembly” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic or other components, might be combined in a single package or separately maintained and might further be distributed across multiple locations.
Additionally, the various embodiments set forth herein can be described in terms of exemplary block diagrams, flow charts and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives might be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration.
Although the preceding description contains significant detail in relation to certain preferred embodiments, it should not be construed as limiting the scope of the disclosure but rather as providing illustrations of the preferred embodiments.
Embodiments of the present disclosure encompass kits having one or more components of a system as disclosed herein. In some embodiments, the kit includes one or more system components, along with instructions for using the component(s) for example according to any of the methods disclosed herein.
All features of the described systems and devices described herein can be applicable to the described methods mutatis mutandis, and vice versa.
In addition, each reference provided herein is incorporated by reference in its entirety to the same extent as if each reference were individually incorporated by reference. Relatedly, all publications, patents, patent applications, journal articles, books, technical references, and the like mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference, or the like was specifically and individually indicated to be incorporated by reference.
While preferred embodiments of the present disclosure have been shown and described herein, it will be understood to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from embodiments of the present disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims the benefit of U.S. Provisional Application No. 63/717,265, filed Nov. 6, 2024, and U.S. Provisional Application 63/101,187, which was originally filed Sep. 25, 2024 as U.S. application Ser. No. 18/896,710 before being converted to provisional, and is a continuation-in-part of U.S. patent application Ser. No. 17/226,802, filed Apr. 9, 2021, which claims the benefit of U.S. Provisional Application 62/972,952, filed Feb. 11, 2020, each of which are incorporated herein by reference in their entirety as if repeated herein.
| Number | Date | Country | |
|---|---|---|---|
| 63101187 | Sep 2024 | US | |
| 63717265 | Nov 2024 | US | |
| 62972952 | Feb 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17226802 | Apr 2021 | US |
| Child | 19020502 | US |
