Urethral catheterization device

Abstract

A device (10) for distraction of a patient's labia, the device (10) comprising: a body portion (12) comprising a proximal section (32) and a distal section (22) wherein the distal section (22) of the body portion (12) is for insertion into a patient's vagina; and first and second wings (14, 16) extending from the proximal section (32) of the body portion (12), the first and second wings (14, 16) being configured, in use, to urge and thereby distract the labia; wherein the first and second wing portions (14, 16) are rotatable about the body portion (12) such that the first and second wing portions (14, 16) are rotatable relative to each other during insertion between the female lips.

Description

[0001] The present invention relates to a device for spreading the labia of a patient and a method for assisted urinary catheterization using the device.

[0002] For female patients, there are various medical procedures that require access to body parts located below the patient's labia. For example, catheterization requires inserting a catheter into the patient's urethra to drain urine from the bladder. In female patients, the urethra is often hidden below the patient's labia, and therefore the labia must be moved apart before the urethra can be accessed. This spreading of the labia is typically performed manually by the practitioner using one hand. However, to ensure that the area remains completely sterile during the procedure, the practitioner must maintain their hand in the spread position throughout the procedure. As a result, the practitioner will only have one hand free to perform the actual procedure, and a second practitioner will be required to perform any operations that the first practitioner cannot complete using only one hand. For example, the second practitioner may need to hand instruments to the first practitioner during the procedure. This makes the procedure both time-consuming and labor-intensive, as both practitioners must work together to complete the procedure.

[0003] Manually spreading the labia by hand presents additional drawbacks due to the stringent sterilization requirements associated with medical procedures such as catheterization. For example, if the first practitioner loses control of the labia and they return to their natural position, the area is no longer considered sterile and the entire procedure must be restarted. This prolongs the time required for the procedure and generates significant waste. Furthermore, such procedures naturally carry the risk of infection, which increases the more times the procedure must be repeated. The risk of patient injury also increases when multiple attempts are required, along with increased patient discomfort.

[0004] Therefore, there is a need for an improved, "hands-free" method of spreading a female patient's labia during medical procedures.

[0005] According to a first aspect of the present invention, there is provided a device for spreading a patient's labia, the device comprising:

[0006] a body portion comprising a proximal section and a distal section, wherein the distal section of the body portion is for insertion into a patient's vagina; and

[0007] a first wing and a second wing extending from a proximal section of the body portion, the first wing and the second wing being configured to push against and thereby spread the labia when in use;

[0008] The first wing portion and the second wing portion can rotate around the main body portion, so that the first wing portion and the second wing portion can rotate toward each other during insertion between the labia.

[0009] The device of the first aspect enables a user to easily access body parts typically at least partially obscured by the labia, without requiring the user to manually hold the labia apart. That is, the device of the first aspect enables the user to freely use both hands when accessing body parts typically obscured by the labia, as the wings effectively replace the user's hands that would normally be used to hold the labia apart. Furthermore, the device provides a particularly reliable and consistent method of spreading the labia, as the device is held in place during use via the distal section of the body portion, which is secured within the vagina.

[0010] The device is used to spread the labia majora of a patient, such as the labial folds of a human patient, and in particular the labia majora of a patient. The device can also be used to spread both the labia majora and labia minora of a patient. The device can be used to hold the labia outward and / or move the labia outward, away from the urethra. The device can be used to hold the labia apart / spread the labia to expose at least the patient's urethra. As discussed further below, a method of using the device can include using one hand to spread the labia majora and then applying the device to the patient. Manually spreading the labia majora can be performed in a conventional manner, such as by reaching down with a finger from above, i.e., downward, toward the anus.

[0011] The body portion may comprise a hollow tube. Thus, the body portion may comprise an opening extending along its length. The opening may be suitable for receiving other instruments, such as a fluid pump and / or an inflatable balloon. The body portion or a portion thereof may comprise a flexible material to facilitate easy insertion into the vagina. Additionally, or alternatively, the body portion or a portion thereof may comprise a rigid material and / or a rigid form for holding the wing portion securely in place. For example, a distal section of the body portion may comprise a flexible material, while a proximal section of the body portion may comprise a rigid material. Alternatively, the body portion may be entirely composed of a monolithic body comprising the same material, such as by molding or additive manufacturing of a single material (such as a polymer material discussed below). The monolithic body may also include the wing portion, so that the wing portion may form a single piece together with the body portion.

[0012] The proximal section of the body portion may be the section farthest from the patient's body during use, i.e., closer to the user's hand. The distal section of the body portion may be the section closest to and / or located within the patient's body during use. The proximal section may extend from one end of the body portion (i.e., the proximal end), while the distal section may extend from the opposite end of the body portion (i.e., the distal end).

[0013] The proximal portion of the main body (including the distal segment) can be configured to extend 60-100 mm, such as approximately 80 mm, into the vagina. The distal segment can be securely held in place by contact with the vaginal wall. Therefore, the distal segment can be considered to act as a fixation device for the device, as the distal segment can establish a secure attachment between the device and the patient's body during use. When in use, the wings of the device can span the distance between the vagina and the uppermost part of the labia. In this way, the distal segment can further be considered to act as a positioning device for the device, as the positioning of the distal segment in the vagina can provide a reference point to ensure that the wings are always correctly positioned relative to the labia. The wings can each have a length ranging from 40-100 mm, such as approximately 50-70 mm. The length can be measured via a straight line from the main body to the end of the wing. The device can be set to different sizes to accommodate patients of different body sizes.

[0014] In use, the first and second wings may extend in an upward direction from the body. In this context, the "upward" direction is defined relative to the device during use, and thus, during use, the wings may be considered to extend in a direction from the patient's vagina toward the patient's urethra. The first and second wings may extend from a position adjacent to the vagina to a position adjacent to the uppermost portion of the labia. That is, the first and second wings may each include a base adjacent to the vagina and a tip adjacent to the uppermost portion of the labia. The base of the wing may be the end where the wing is attached to the body, while the tip of the wing may be the opposite end of the wing. The wings may extend symmetrically around the body. For example, the wings may extend upward by 35 to 70 mm and each extend outward (away from each other) by approximately 25-35 mm, thereby resulting in a width of the device within the range of 50-70 mm, such as a width within the range of 55-60 mm. This width may be the width when no force is applied to the device, such as in the open position described below.

[0015] The first and second wing portions can be flexibly attached to the body portion so as to be capable of rotational movement about the body portion; that is, the wings can be bent at least at their bases where they are attached to the body portion so that their distal ends can move approximately along an arc about the axis of the body portion. The first and second wing portions can comprise an elastic material, such as a polymer material. Thus, the first and second wing portions can rotate by elastic deformation. Possible materials for the wings include polypropylene or polyurethane materials, which have available medical-grade components and would be suitable.

[0016] The main body may include a slit extending from the proximal end of the main body. The slit can be considered a "cutout" section of the outer wall of the main body at the proximal end. For example, the slit can be rectangular in shape. The slit can extend to a point along the length of the main body located behind the proximal edge of each wing (i.e., closer to the distal end of the main body). For example, the slit can extend to the widthwise midpoint of each wing. The size and shape of the slit can provide additional flexibility to the device, particularly the wings. Thus, the slit can facilitate rotation of the wings.

[0017] However, the body portion does not necessarily include such slits. In order to achieve the required flexibility of the device, the device may include a suitably flexible material to allow the wings to be rotated towards each other. For example, the device may include polypropylene, in particular a polypropylene homopolymer. The device may include medical grade polypropylene, such as Lotte SJ-170M polypropylene. In particular, the wings may include polypropylene, Lotte SJ-170M polypropylene and / or a polypropylene homopolymer. In addition or alternatively, the body portion may include polypropylene, Lotte SJ-170M polypropylene and / or a polypropylene homopolymer. Preferably, as described above, the wings and the body portion are formed as a single piece, in which case the piece is made of one of the above-mentioned materials.

[0018] The first and second wings can be separated from each other by a wing gap. The wing gap can be the area between the inner surfaces of each wing, where the inner surfaces of the wings can be surfaces facing the body of the device. The wing gap can be defined by the wing span, which can be the distance between the tips of each wing. When at rest, the first and second wings can be configured in an open position. The open position can be the position where the wing span is at its maximum. In some examples, the wing span in the open position can be in the range of 25 to 40 mm, such as 30 to 35 mm. In this case, the total width of the outer curved portions of the wings can be, as described above, for example, in the range of 50 to 70 mm, such as 55 to 60 mm. The wings can be elastically biased, for example, by their elasticity, toward the open position. The first and second wings can be elastically deformable so that they rotate toward each other into an insertion position. The insertion position can be the position each wing maintains during insertion between the labia. A user can apply an inward force to the wings, thereby elastically deforming the wings into the insertion position. When the wings are in the insertion position, the wing span can be minimal. When the wings are in the insertion position, the wing spacing can be zero. That is, the tips of the wings can touch each other in the insertion position, such as by bending the elastic wings toward each other so that their tips touch. Thus, during insertion of the wings between the labia, the wing spacing can be minimized, thereby making it easier for a practitioner to use one hand to place the wings between the labia while using the practitioner's other hand to spread the labia apart during initial positioning of the device.

[0019] The wings can be in a spread position during use. The wings can be elastically biased from the insertion position toward the spread position, meaning that when no force is applied, the wings tend to move from the insertion position toward / through the spread position. If the device is not in use and there are no forces acting on the labia, and no other forces, the wings remain stably in the spread position. The spread position of the wings can be a position where the force exerted on the wings by the labia during use equals the elastic force exerted on the labia by the wings. In other words, the spread position can be a position where the only external force acting on the wings comes from the patient's labia. This ensures that the device can spread the labia during use without constant interference from the user. The wing spacing when in the spread position can be greater than the wing spacing when in the insertion position. The spread position can depend on the shape and size of the labia of a particular patient. For example, for some patients, the spread position can be the same as the spread position. Thus, the device can be used with a wide range of labia sizes and shapes without causing discomfort to the patient.

[0020] The first and second wings may have a curved form. In particular, the first and second wings may have a curved form when at rest (i.e., when no external force is acting on them). The first and second wings may be curved along their width and / or their length. The width of a wing may be the extent of the wing between its proximal edge (i.e., the edge closest to the proximal end of the main body) and its distal edge (i.e., the edge closest to the distal end of the main body). In this case, the thickness of the wing may exist in a direction perpendicular to the length and width, for example, in a direction transversely across the labia, and this can also be considered the thickness of the wing as seen when viewed along the body segment toward the patient's labia / vagina. The length of the wing may be the extent of the wing between its base and tip. Thus, the first and second wings may include two axes of curvature. The thickness of the wing may also differ, resulting in different curvatures at the distal and proximal edges and inward / outward surfaces of the wing.

[0021] As described above, in some examples, each wing can have a length ranging from 40-100 mm, such as approximately 50-70 mm. The width of the wing, i.e., its dimension from distal to proximal, can range from 10-35 mm, such as 15-25 mm. The thickness can vary along the length of the wing, for example, to be designed to conform to the curve of the labia. The thickness of the wing, i.e., the thickness dimension when viewed facing the patient's labia, can range from 5-10 mm, such as 6-8 mm, and can vary along the curve of the wing, such as to allow for varying degrees of firmness.

[0022] The form of the wing portion can be defined relative to the vertical axis and the longitudinal axis of the device. The longitudinal axis can pass through the center of the body portion and extend from the proximal end to the distal end of the body portion. The vertical axis can extend perpendicular to the longitudinal axis and, during use of the device, can be parallel to a line extending between the vagina and the urethra. The vertical axis can extend through the body portion at a location along the length of the body portion corresponding to the location where the wing portion is attached to the body portion.

[0023] The wing portion may be bent in the vertical direction toward the body portion. For each wing portion, the angle between the wing portion and the vertical axis may be a positive obtuse angle at the base and a positive acute angle at the end. The angle between the wing portion and the vertical axis may be zero at the midpoint of the wing portion along its length. The distance between the inner surface of the wing portion and the vertical axis may increase from the base to the midpoint of the length of the wing portion and may decrease from the midpoint of the length of the wing portion to the end. The inner surface of the wing portion may be concavely curved in the vertical direction, while the outer surface of the wing portion may be convexly curved in the vertical direction. The degree of curvature in the vertical direction may vary along the width of the wing portion, or may remain constant along the width of the wing portion. The degree of curvature in the vertical direction (i.e., the vertical curvature) may vary along the length of the wing portion. In particular, the vertical curvature may be maximum at the end of the wing portion. The vertical curvature may increase along the length of the wing portion (i.e., from the base to the end). The wings may include a first degree of vertical curvature along the length of the wings from the base to the transition point, and may include a second degree of vertical curvature from the transition point to the tip, wherein the first degree of vertical curvature is less than the second degree of vertical curvature. In this way, the wings can more accurately conform to the shape of the labia, thereby maintaining the spreading force applied to the labia during use within a range that is comfortable for the patient.

[0024] The wing portion can be bent away from the main body portion in the longitudinal direction. For each wing portion, the angle between the wing portion and the longitudinal axis can be a positive acute angle at the proximal edge and a positive obtuse angle at the distal edge. The angle between the wing portion and the longitudinal axis can be zero at the midpoint of the wing portion along its width. The distance between the inner surface of the wing portion and the longitudinal axis can decrease from the proximal edge to the midpoint of the width direction of the wing portion, and can increase from the midpoint of the width direction of the wing portion to the distal edge. The inner surface of the wing portion can be convexly curved in the longitudinal direction, while the outer surface of the wing portion can be concavely curved in the longitudinal direction. The longitudinal curvature can vary along the width of the wing portion and / or the length of the wing portion, or can remain constant along the width of the wing portion and / or the length of the wing portion. In particular, the longitudinal curvature can be minimum at the end and base of the wing portion and can be maximum at the midpoint of the length direction of the wing portion.

[0025] Thus, due to their curved form, the wings of the device can mimic the approximate shape of the labia when in the spread position, thereby ensuring maximum comfort for the patient during use, as well as ensuring a secure "hands-free" engagement with the labia.

[0026] The wings may each include a rounded tip. The wings may each include a rounded edge. In this way, it is ensured that the wings do not feel as if they "cut into" the patient during use.

[0027] The wings may be elastically deformable to provide an increased curvature in the insertion position. That is, the curvature of the wings in the vertical direction and / or longitudinal direction may increase during the elastic deformation of the wings from the open or stretched position to the insertion position. For example, the wings may transition from a generally V-shaped configuration to a generally O-shaped configuration, wherein in the O-shape there is contact between the ends of the wings at the top of the O. When the user's hands pre-spread the labia, i.e., in the conventional manner as described above, the device may be in an optimal shape for engagement with the labia by utilizing the increased curvature. When the wings are released into the open or stretched position, the wings may elastically return to their original form, such as with the wingspitch (the distance between the wing tips) changing from zero or near zero in the open position to a wingspitch in the range of 25 to 40 mm, such as a wingspitch in the range of 30 to 35 mm.

[0028] The device may further include an inflatable balloon portion attached to the distal end of the body portion. For example, the body portion may extend to a total length of 90-120 mm, such as approximately 95 mm or 100 mm, with the distal section extending 20-40 mm (optionally 25-35 mm) from the position of the wing portion, and the balloon portion extending an additional 35-60 mm (optionally 40-50 mm) to obtain a length of 60-100 mm for insertion into the patient's vagina. The inflatable balloon portion may be a hollow tube that can be inserted into the body portion. The inflatable balloon portion may be fixedly attached to the distal section of the body portion. The inflatable balloon portion may be fixedly attached to the distal section using any suitable fixing means (such as an adhesive).

[0029] Therefore, the inflatable balloon portion of the device is configured to be inserted into the vagina together with the distal section of the main body. The inflatable balloon portion can be used to secure the distal section of the main body within the vagina. The inflatable balloon portion can be configured to apply pressure to the vaginal wall when inflated, thereby securing the distal section of the main body within the vagina. In some examples, the balloon is configured to inflate to a diameter of 25-35 mm, for example, approximately 30 mm. The length of the balloon, which can extend along the vagina during use, is in the range of 35-50 mm, such as a length in the range of 40-45 mm. The inflatable balloon portion can be any suitable medical balloon, such as a Foley balloon. The balloon can be made of a suitable material, such as silicone, polyurethane, or PVC. The inflatable balloon portion can be configured to inflate when inserted into the vagina. Therefore, the inflatable balloon portion can provide additional stability to the device and ensure that the wings remain securely in place during use of the device.

[0030] The device may include a fluid pump coupled to the inflatable balloon portion. The fluid pump may be configured to supply fluid to the inflatable balloon portion. In particular, the fluid pump may be an air pump and may be configured to supply gas to the inflatable balloon portion. However, it should be understood that the fluid pump may be configured to supply any suitable fluid to the inflatable balloon portion, such as water, and is not limited to an air pump. The fluid pump may be a syringe. The fluid pump may be configured to fill the inflatable balloon portion with fluid during inflation of the inflatable balloon portion. The fluid pump may be configured to discharge the fluid from the inflatable balloon portion during deflation of the inflatable balloon portion. The fluid pump may be removably inserted into the hollow tube of the main body portion, in particular into the proximal section of the main body portion. The fluid pump may be coupled to the inflatable balloon portion via the main body portion. The device may be configured such that the fluid pump may be detachable from the main body portion after the inflatable balloon portion is inflated. In this way, it is ensured that the fluid pump does not interfere with any procedure being performed on the patient.

[0031] The first and second wings can be attached to the body at points inward from the proximal end of the body. Thus, the proximal section of the body can extend a distance beyond the wings. In this way, the proximal section of the body can provide a gripping point for the user. This can allow the user to securely hold the device when initially positioning it on the patient.

[0032] The first and second portions may be integrated with the main body. The first and second portions and the main body may be a unitary body. The wings and / or the main body may include an antimicrobial coating. Thus, the risk of infection from using the device may be minimized.

[0033] During urinary catheterization of a female patient, the labia must be held open for the duration of the procedure to allow for unobstructed, uninterrupted access to the urethra. Therefore, the device of the first aspect is suitable for preparing a patient for urinary catheterization. In particular, the device is suitable for preparing a patient for a single-person urinary catheterization. This is because the device eliminates the need for a person to manually hold the labia open during any procedure performed on the patient. Therefore, when using the device of the first aspect, procedures such as urinary catheterization can be performed by a single person, whether that person is a licensed physician or the patient themselves.

[0034] According to a second aspect of the present invention, there is provided a method of using the device of the first aspect to spread the labia of a patient, the method comprising: inserting the distal section of the body portion into the patient's vagina;

[0035] holding the first wing and the second wing and rotating them toward each other;

[0036] positioning the first wing and the second wing between the labia; and

[0037] Release the first wing and the second wing so that they rotate away from each other and push against the labia.

[0038] The method may use the device according to the first aspect, including any of the optional features given for the device of the first aspect. The step of inserting the distal section into the patient's vagina may be performed simultaneously with the step of rotating and positioning the wings between the labia. Thus, inserting the device into the vagina also moves the wings to the desired position between the labia.

[0039] The method may include rotating the first and second wings toward each other until the distance between the wings is minimized. The method may include rotating the first and second wings toward each other until their distal ends touch, i.e., until the distance between the distal ends of each wing is zero. The method may include manually spreading the labia prior to inserting the distal segment. This may be done in any conventional manner, such as by reaching down from above, i.e., downward toward the anus. One hand may be used to spread the labia, while the other hand may be used to insert the device and assist in performing the method described above.

[0040] The method may include attaching the inflatable balloon portion to the distal segment of the body portion prior to inserting the distal segment into the vagina. The method may include inserting the inflatable balloon portion into a hollow tube of the body portion. The method may include fixedly attaching the inflatable balloon portion to the distal segment of the body portion, for example, using an adhesive.

[0041] The method may include inserting the inflatable balloon portion into the patient's vagina along with the distal section of the body portion. The method may include inflating the inflatable balloon portion to secure the distal section of the body portion within the vagina. The method may include inflating the inflatable balloon portion after the wings are released into the expanded position. This allows the user to ensure that the wings are correctly positioned before securing the device in place. The method may include inflating the inflatable balloon portion until the inflatable balloon portion applies a securing pressure against the vaginal wall.

[0042] The method may include inflating the inflatable balloon portion using a fluid pump (such as an air pump or a water pump). The method may include removably attaching the fluid pump to a proximal section of the body portion. The method may include coupling the fluid pump to the inflatable balloon portion, for example, via the body portion. The method may include removing the fluid pump from the device once the inflatable balloon portion has been inflated. The method may include deflating the inflatable balloon portion using the fluid pump.

[0043] A proximal section of the body portion may extend beyond the wings, and the method may include holding the proximal section of the body portion during positioning of the device.

[0044] The method may be suitable for preparing a patient for catheterization. In particular, the method may be suitable for preparing a patient for single-person catheterization, wherein a single person can perform the catheterization without the need for assistance from another person to manually hold the labia apart during the catheterization.

[0045] The method may be adapted for urinary catheterization and, thus, may further comprise inserting the catheter into the patient's urethra after the first and second wings have been released. The method may comprise inserting the catheter into the urethra after the inflatable balloon has been inserted into the vagina and inflated. The method may comprise inserting the catheter into the patient's bladder via the urethra. The method may comprise inflating the inflatable balloon of the catheter while the catheter is within the bladder, thereby securing the catheter in place. The method may comprise attaching the catheter to a drainage bag.

[0046] The method may include removing the catheter from the patient. Once the catheter is removed, the method may include deflating the inflatable balloon of the labiaplasty device and removing the inflatable balloon portion from the vagina. Once the catheter is removed, the method may include rotating the first wing and the second wing toward each other (e.g., until the distance between the wings is minimized or zero) and removing the first wing and the second wing from between the labia. This may allow the labia to return to their natural position once catheterization is complete.

[0047] According to a third aspect of the present invention, there is provided a device for spreading a patient's labia, the device comprising:

[0048] a main body; and

[0049] a first wing portion and a second wing portion extending from the body portion, the first wing portion and the second wing portion each being curved along a width thereof and a length thereof to conform to the shape of the labia;

[0050] wherein the first and second wings are resiliently biased into a position where, in use, they push against and thereby spread the labia; and

[0051] The first wing portion and the second wing portion are elastically deformable to an insertion position, wherein they are rotated toward each other around the body portion.

[0052] The device of the third aspect utilizes an inward rotational movement of the wings during insertion between the labia. This allows the distal ends of the wings to move toward each other and optionally contact each other, as described above. The wings can also increase their curvature along their length as they elastically deform, e.g., the wings elastically bend along their length. The inward rotation during elastic deformation moves the wings into an insertion position, i.e., a position in which the device is ready to engage the labia, as described above in the first and second aspects. In contrast, upon release from this insertion position, the wings rotate outward to a spread position, optionally with a reduced degree of curvature along their length. This advantageously occurs automatically due to the resilient bias of the wings, such as due to the elastic properties of their material and / or shape. Furthermore, when the user releases the device and leaves it on the patient, the device maintains the spread configuration. This allows practitioners to easily and hands-free spread the labia during any procedure requiring access to body parts normally obscured by the labia, while ensuring patient comfort during the spread.

[0053] The body portion of the device may include a proximal section and a distal section. The distal section of the body portion may be configured to be inserted into a patient's vagina. The first wing portion and the second wing portion may extend from the proximal section of the body portion.

[0054] The apparatus of the third aspect may include any of the optional features described in relation to the apparatus of the first aspect.

[0055] According to a fourth aspect of the present invention, there is provided a method of spreading a patient's labia using the device of the third aspect. The method comprises: rotating a first wing and a second wing toward each other; positioning the first wing and the second wing between the labia; and releasing the first wing and the second wing such that the wings return to their resiliently biased positions.

[0056] The method may use an apparatus comprising any of the optional features described in relation to the apparatus of the third aspect.The method may include any of the optional steps described in relation to the method of the second aspect.

[0057] Certain embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0058] Figure 1 is a perspective view of a medical device including a body portion and two wings;

[0059] Figure 2 An end view of the device is shown, along with a balloon portion attached for securing the device within the vagina;

[0060] Figure 3 is a side view of the device;

[0061] Figure 4 Another perspective view is shown;

[0062] Figure 5 and Figure 6 Shown with Figure 1 a balloon portion for use with the device, wherein the balloon is in uninflated and inflated configurations;

[0063] Figure 7 A medical device is presented, comprising a body portion and wings, a balloon portion, and also a pump for the balloon; and

[0064] Figure 8 is a perspective view of an alternative form of the device.

[0065] Figure 1A device 10 is shown for spreading the labia of a female patient during a procedure such as urinary catheterization. The device 10 includes a body portion 12 from which extend first and second wings 14, 16. During use, outer surfaces 18 of wings 14, 16 act on the patient's labia to push them outward, thereby spreading them apart. This allows the practitioner to access body parts that are typically located beneath the labia and hidden, such as the urethra.

[0066] To use the device, a practitioner first manually spreads the labia with one hand and then applies the device to the patient. Manual spread of the labia can be performed in a conventional manner, such as by reaching down with a finger from above, i.e., toward the anus. The device then holds the labia in the spread position and applies force to further spread the labia.

[0067] In order to properly position the device 10 so that the wings 14, 16 can interact with the labia as intended, the body portion 12 is provided with a distal section 12 for insertion into the patient's vagina. Thus, the distal section 12 provides a reference point for the practitioner when initially positioning the device 10 on the patient and thereby ensures that the wings 14, 16 remain in the correct position and orientation during use. Figure 1 The body portion 12 is shown as a hollow cylindrical tube having an opening 22 at its distal end. The opening 22 is suitable for receiving other medical instruments that can be used in conjunction with the device 10, as will be described below. Figures 5 to 7 Further described.

[0068] The wings 14, 16 are made of a resilient material and are resiliently biased to Figure 1The device is positioned in the open position shown. For example, the material can be medical-grade polypropylene or polyurethane, and the wings 14, 16 are advantageously formed as a single, integral piece with the body 12, as shown. In the open position, the distance between the ends 24 of the wings 14, 16 (referred to as the wingspan, WD) is at its maximum. However, the elasticity of the wings 14, 16 enables them to rotate about the longitudinal axis A of the body, thereby exiting their static open position. The user can grasp the wings 14, 16 and rotate them toward each other until their ends 24 touch, i.e., until the wingspan WD between the ends 24 is zero. This position is referred to as the device's insertion position because the area between the wings 14, 16 is minimized, allowing the wings 14, 16 to be inserted between the labia. This requires the user to manually spread the labia with their free hand. Once the wings 14, 16 are correctly positioned between the patient's labia, the user releases the wings 14, 16 and rotates them outward toward the open position. The expanded position is the position of wings 14, 16 during use, in which the outward spring force of wings 14, 16 equals the inward reaction force from the labia. Therefore, depending on the patient's specific anatomy, the wing distance WD in the expanded position may be less than the wing distance WD in the open position, or the expanded position may be the same as the open position. Thus, device 10 can be adjusted to the specific size and / or shape of a patient's labia, further ensuring maximum patient comfort. Thus, the elastic deformability of wings 14, 16 allows device 10 to be easily positioned on the patient during both insertion and expansion.

[0069] like Figure 1 As shown, wings 14, 16 are curved along their length l and along their width w. Specifically, wings 14, 16 each curve toward body portion 12 along their length l and away from body portion 12 along their width w. In other words, inner surface 26 of wings 14, 16 is convexly curved along their width w and concavely curved along their length l; whereas outer surface 18 of wings 14, 16 is concavely curved along their width w and convexly curved along their length l. This mimics the shape of the labia to ensure maximum patient comfort.

[0070] Now go to Figure 2 , it can be seen more clearly how the wings 14, 16 curve inwardly along their lengths towards the body 12. This lengthwise curvature can be defined relative to the vertical axis B of the device. In particular, it can be seen that for each wing 14, 16, the angle α between the base 28 and the vertical axis B is b is a positive obtuse angle, and the angle α between the end 24 and the vertical axis B is t is a positive acute angle. Figure 2 It can be further seen that the curvature of the wings 14, 16 is not constant along their length l. Instead, the curvature increases from the base 28 to the tip 24 of the wings 14, 16, i.e. the angle αt Ratio angle α b Closer to 90°. This further simulates the shape of the labia and prevents the labia from being pushed too far apart, which could cause excessive force and discomfort to the patient.

[0071] exist Figure 2 , an inflatable balloon portion 34 is shown extending from the distal end 20 of the body portion 12; this will be referred to below. Figures 5 to 7 A further detailed description is given.

[0072] Figure 3 A clearer view of the curvature of the wing 14 along its width w is shown. Figure 3 Wing 14 is shown, but wing 16 exhibits the same shape and curvature. Figure 3 It can be seen that the curvature in the width direction is not constant along the length l of the wing portion 14, but the curvature in the width direction is constant at the midpoint M of the length direction of the wing portion 14. L The width direction curvature is greater than that at the base 28 or the end 24. In other words, the width direction curvature is greater from the base 28 to the length direction midpoint M L Increase, and then from the length direction midpoint M L The wings 14, 16 are tapered to the distal end 24. This configuration of the wings 14, 16 allows them to more effectively spread the labia when in use. Figure 3 It is also shown that the wings 14 are rounded at their distal ends 24, which prevents the wings 14, 16 from feeling like they are "cutting into" the patient during use.

[0073] Figure 4 An alternative view of the device 10 is shown. Figure 4 , it can be seen that the body portion 12 includes a slit 30 at its proximal section 32, which is the section of the body portion 12 opposite the distal section 22. The slit 30 is rectangular in shape and extends from the proximal end of the body portion 12 to a point behind (or trailing) the proximal edges of the wings 14, 16. The slit 30 enhances the flexibility of the wings 14, 16, making it easier for the user to rotate them into the insertion position. In some embodiments, such as Figure 8 In the embodiment shown, the device 10 does not include a slit 30 .

[0074] The device 10 may include other features such as Figure 5 and Figure 6 The inflatable balloon portion 34 is shown. The inflatable balloon portion 34 includes an attachment section 36, a central tube 38, and a flexible balloon 40. The attachment section 36 and the central tube 38 are inserted into the body portion 12, as shown. Figure 7As shown, at least central tube 38 is bonded to the inner wall of body portion 12 to securely attach inflatable balloon portion 34 to device 10. Attachment section 36 and central tube 38 are hollow so that fluid can pass through body portion 12 into flexible balloon 40, thereby inflating balloon 40. Figure 5 The balloon 40 is shown in its deflated state, ie its state during insertion into the vagina. Figure 6 The balloon 40 is shown in its expanded state, which occurs after the wings 14, 16 have been released and properly positioned in the expanded position. As the balloon 40 expands, it contacts and forms a snug fit with the vaginal wall, thereby securing the device 10 in its expanded position during use.

[0075] All components of the inflatable balloon portion 34, including the attachment section 36 and the central tube 38, can be made of a flexible material to facilitate insertion into the vagina along with the distal section 22 of the body portion 12. The attachment section 36 is threaded for attachment to a fluid pump 42, such as Figure 7 As shown. The fluid pump 42 is inserted through the body portion 12 and is screwed or otherwise coupled (e.g., friction fit, bayonet-type assembly, etc.) to the inflatable balloon portion 34 via the attachment section 36. Thus, the attachment between the inflatable balloon portion 34 and the fluid pump 42 is reversible, and once the balloon 40 is inflated and the device 10 is secured in its expanded position, the fluid pump 42 can be removed. Fluid (preferably air) is pumped into the inflatable balloon portion 34 by the fluid pump 42, thereby inflating the balloon 40.

[0076] Thus, a practitioner wishing to catheterize a female patient 10 can do so with both hands free, as the device 10 itself acts to spread / hold the labia apart, thereby allowing access to the urethra. To apply the device to a patient, after initially manually spreading the labia apart, the practitioner first inserts the distal section 22 with the inflatable balloon portion 34 into the vagina. The wings 14, 16 are then grasped and rotated toward each other into an insertion position, wherein the distance between the tips of the wings 14, 16 is minimized. In the insertion position, the wings 14, 16 are positioned between the patient's labia. Once properly positioned between the labia, the wings 14, 16 are released and rotated outward to push / hold the labia apart. The practitioner can withdraw their hands while / after the device is in place. Once the outward force from the wings 14, 16 matches the internal counterforce of the labia, the wings 14, 16 stabilize in their spread position. When the practitioner is satisfied with the final expanded position of the wings 14, 16, fluid is pumped into the inflatable balloon portion 34 using the fluid pump 42 until the balloon 40 expands, pushing against the vaginal wall. Once the wings 14, 16 are positioned between the labia, or before the device 10 is placed on the patient, the fluid pump 42 can be attached to the rest of the device 10. Once the device 10 is secured in place on the patient, the fluid pump 42 can be removed from the rest of the device 10 and set aside to prevent the pump 42 from obstructing the procedure. When the procedure is complete, the practitioner can reattach the pump 42 to the device and use it to deflate the balloon 40. To remove the device 10, the practitioner can again rotate the wings 14, 16 toward each other and remove them from the labia. The distal section 22 and inflatable balloon portion 34 can then be removed from the vagina and the device discarded.

[0077] Figure 8 An embodiment of the device 10 is shown in which the slit 30 is absent in the proximal section 32 of the body portion 12. In this embodiment, the device 10 is made of a suitable flexible material to allow the wings 14, 16 to rotate toward each other by deformation. In particular, Figure 8 The wings 14, 16 and / or the body 12 are made of a medical grade polypropylene homopolymer such as Lotte SJ-170M polypropylene.

[0078] Thus, the device 10 provides a comfortable, reliable, and "hands-free" mechanism for opening and maintaining the patient's labia without the need for constant intervention by a healthcare professional. Thus, procedures that would normally require full manual opening of the labia, such as catheterization, can now be performed by a single physician.

Claims

1. A device for spreading a patient's labia, the device comprising: a body portion comprising a proximal section and a distal section, wherein the distal section of the body portion is for insertion into the patient's vagina; and first and second wings extending from the proximal section of the body portion, the first and second wings being configured to push against and thereby spread the labia in use; The first wing portion and the second wing portion are rotatable about the body portion, so that the first wing portion and the second wing portion can rotate toward each other during insertion between the labia.

2. The device according to claim 1, wherein The first wing and the second wing each include an elastic material.

3. The device according to claim 1 or 2, wherein: The first and second wings are configured to elastically deform during rotation toward each other.

4. The device according to any one of the preceding claims, wherein The first and second wings are rotatable to an inserted position, where the distance between distal ends of the first and second wings is minimized.

5. The device according to any one of the preceding claims, wherein Each of the first and second wing portions is curved along its length toward the body portion.

6. The device according to claim 5, wherein The degree of curvature along the length of each wing is greatest at the distal end of the wing.

7. A device according to any one of the preceding claims, wherein Each of the first and second wing portions is curved along a width thereof away from the body portion.

8. The device according to claim 7, wherein The degree of curvature along the width of each wing is greatest at the mid-length of the wing.

9. The device of any preceding claim, comprising an inflatable balloon portion attached to the distal section of the body portion, the inflatable balloon portion for securing the distal section of the body portion within the vagina.

10. The device according to claim 9, wherein The expandable balloon portion is insertable into the distal section of the body portion.

11. The device according to claim 9 or 10, wherein: The device includes a fluid pump coupled to the inflatable balloon portion, the fluid pump being configured to fill the inflatable balloon portion with fluid during inflation.

12. The device according to claim 11, wherein The fluid pump is coupled to the inflatable balloon portion via the body portion.

13. The device according to any one of the preceding claims, wherein the first and second wings being resiliently biased into a position where, in use, they push against and thereby spread the labia; as well as The first wing portion and the second wing portion are elastically deformable to an insertion position, wherein the first wing portion and the second wing portion are rotated toward each other around the body portion.

14. The device according to claim 13, wherein The distance between the tips of the first and second wings is minimum in the inserted position.

15. The device according to any one of the preceding claims, wherein The device is suitable for preparing the patient for urinary catheterization.

16. A method of spreading a patient's labia using the device of any preceding claim, the method comprising: inserting the distal section of the body portion into the patient's vagina; holding the first wing and the second wing and rotating them toward each other; positioning the first wing and the second wing between the labia; as well as The first and second wings are released so that they rotate away from each other and push against the labia.

17. The method according to claim 16, wherein Rotating the first and second wings includes rotating the first and second wings until a distance between an end of the first wing and an end of the second wing is minimized.

18. The method according to claim 17, wherein Rotating the first and second wings includes rotating the first and second wings until a distance between tips of the wings is zero.

19. The method according to any one of claims 16 to 18, comprising: attaching an inflatable balloon portion to the distal section of the body portion before inserting the distal section into the vagina; inserting the inflatable balloon portion together with the distal section of the body portion into the patient's vagina; The inflatable balloon portion is inflated to secure the distal section of the body portion within the vagina.

20. The method according to claim 19, wherein Inflation of the inflatable balloon portion occurs after release of the first and second wings.

21. The method according to any one of claims 16 to 20, wherein The method is used to prepare the patient for urinary catheterization.

22. The method according to claim 21, wherein The method is for catheterizing a patient and further includes inserting a catheter into the patient's urethra after the first and second wings are released.

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