巴西专利BR112020009251A2 vaginal speculum

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专利摘要:
The present disclosure relates to a vaginal speculum comprising a vaginal assembly comprising at least two longitudinal separation elements connected at a distal end for insertion into a subject's vagina. The vaginal speculum is configured to keep the subject's vaginal walls apart, thus allowing examination and / or suturing of at least the posterior part of the vaginal tissue. The present disclosure also relates to a set of vaginal specula which comprises a series of specula according to the first aspect of the invention, in which said specula are provided in predefined sizes, so that the specula are properly adjusted to a series of anatomies. The present disclosure also relates to a method for providing an unobstructed view of at least the posterior part of the vaginal wall during a subject's suture after said subject gives birth.
公开号:BR112020009251A2
申请号:R112020009251-7
申请日:2018-11-09
公开日:2020-10-20
发明作者:Malene Kruse Hegenberger
申请人:Hegenbergerspeculum Aps；
IPC主号:

专利说明:

[0001] [0001] The present invention relates to a vaginal speculum that allows examining and / or suturing at least the posterior part of the vaginal tissue.
[0002] [0002] The vaginal speculum of the invention has a design that is ergonomic for both the patient and the user, providing an unobstructed view of the vaginal tissue and access for examination, suture, surgery or training purposes. BACKGROUND OF THE INVENTION
[0003] [0003] An instrument known as a speculum is often used to dilate or enlarge cavities in the human body for medical examination or operation. The specula for vaginal examination purposes generally comprise parts that are inserted into the vagina to expand and dilate the vaginal walls, connected to a base or handle with a locking mechanism and may include lights, suction devices, comfortable padding, absorbent material or others accessories as needed for the specific task and can be coated with a lubricating or anesthetic gel.
[0004] [0004] For applications such as postpartum suture procedures, where the operator needs to have a clear view and access to the vaginal walls to perform the suture effectively, the devices used involve hooks or traction mechanisms to dilate and pull the vaginal walls for position. Where this is not possible, the operator will use the fingers of one or both hands to dilate the vagina for examination and then keep one or more fingers of one hand in place as a guide for suturing while unable to visualize the actual location the suture. The fingers of one or both hands are then used again to dilate the vagina and inspect the suture result. When training students, the trainer can use their fingers to dilate the vagina while the student performs the suture, requiring the student and trainer to assume restricted postures for long periods. This use of potentially painful or harmful hooks or traction devices,
[0005] [0005] Due to the above mentioned difficulties associated with examining or operating the vagina, it is an objective of the present invention to provide an improved vaginal speculum that provides a clearer and less obstructed view of the area to be examined, sutured or operated that facilitates the process of suture and, moreover, that it is easier to handle. It is also an object of the present invention to provide a vaginal speculum that facilitates examination or operation without the additional use of hooks or fingers of the operator or trainer. It is still an object of the present invention to provide a vaginal speculum that retains the anterior vaginal wall, thereby supporting the bladder, to allow unobstructed view and access for examination, suture or operation. SUMMARY OF THE INVENTION
[0006] [0006] The present disclosure provides a vaginal speculum that provides a clearer and less obstructed view of the area to be examined, sutured or operated and that further facilitates examination or operation without the additional use of hooks or the operator's fingers or coach. For example, the vaginal speculum can be configured to retain the anterior vaginal wall, thereby supporting the bladder to allow unobstructed view and access for examination, suture or operation. The present disclosure further provides a vaginal speculum, which can facilitate the suturing process, such as a vaginal speculum which facilitates the handling of suture materials. The present disclosure also provides a vaginal speculum, which is easier and simpler to insert and remove.
[0007] [0007] In a first aspect, the present disclosure relates to a vaginal speculum comprising a vaginal assembly comprising at least two longitudinal separation elements connected at a distal end for insertion into a subject's vagina.
[0008] [0008] In a preferred embodiment, the vaginal speculum according to the first aspect is configured so that the speculum takes on the desired shape at insertion.
[0009] [0009] A second aspect of the present invention relates to a set of vaginal specula that comprise numerous specula according to the first aspect of the invention, wherein said specula are provided in predefined sizes, so that the specula are properly adjusted to a series of anatomies.
[0010] [0010] A third aspect of the invention relates to a method for providing an unobstructed view of at least the posterior part of the vaginal wall during a subject's suture after said subject has given birth. The method comprises the steps of 1) inserting a longitudinal vaginal assembly of a vaginal speculum into the subject's vagina and 2) engaging a locking element in the vaginal assembly, so that the vaginal assembly creates a transverse separating force to separate and maintain the The subject's vaginal walls are separated, while providing an unobstructed view of at least the posterior part of the vaginal wall for examination and / or suturing of said subject.
[0011] [0011] Advantageously, the vaginal speculum according to the first aspect can be used in the method according to the third aspect. Thus, in a preferred embodiment, the vaginal speculum is configured in such a way that the speculum takes on the desired shape at insertion.
[0012] [0012] A fourth aspect of the invention relates to a method for providing an unobstructed view of at least the posterior part of the vaginal wall during a subject's suture after said subject has given birth. The method comprises the steps of 1) inserting a longitudinal vaginal assembly of a vaginal speculum into the subject's vagina, so that the vaginal assembly creates a transverse separation force to separate and keep the subject's vaginal walls at bay, while providing an unobstructed view at least the posterior part of the vaginal wall for examination and / or suture of said subject.
[0013] [0013] In accordance with the present invention, a vaginal speculum is provided which comprises:
[0014] [0014] a vaginal assembly comprising at least two longitudinal separation elements connected at a distal end for insertion into a subject's vagina,
[0015] [0015] in which the vaginal speculum is configured to keep the subject's vaginal walls apart, thus allowing the examination and / or suturing of at least the posterior part of the vaginal tissue.
[0016] [0016] Preferably, the vaginal speculum further comprises a locking element configured to engage the vaginal assembly to create a transverse separating force at the proximal end of the separating elements to keep the subject's vaginal walls apart.
[0017] [0017] Advantageously, the locking element is an integral part of the vaginal assembly.
[0018] [0018] Conveniently, the locking element is configured for detachable engagement with the vaginal assembly.
[0019] [0019] Preferably, the vaginal assembly and the locking element are shaped so that at least the posterior part of the vaginal tissue is exposed for examination and / or suture when the vaginal assembly is inserted into the vagina and the locking element is engaged in vaginal assembly.
[0020] [0020] Advantageously, the locking element is shaped like an arc or an inverted V.
[0021] [0021] Conveniently, the locking element is predominantly elastic in one or more predefined parts.
[0022] [0022] Preferably, the speculum is configured to expose at least partially a lateral wall of the vagina.
[0023] [0023] Advantageously, the lateral wall of the vagina is at least partially exposed with the use of the speculum in a rotated orientation.
[0024] [0024] Conveniently, the speculum is for use during vaginal suture after the subject has given birth.
[0025] [0025] Preferably the vaginal assembly also comprises proximal base elements configured to rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina.
[0026] [0026] Advantageously, the proximal base elements are flattened and curve outward from the separation elements, so that they can rest on the skin outside the vagina after insertion of the vaginal assembly in the vagina.
[0027] [0027] Conveniently, the proximal base elements are flattened and extend transversely, so that they can rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina.
[0028] [0028] Preferably, the proximal base elements are located at the proximal ends of the separation elements.
[0029] [0029] Advantageously, the proximal base elements are configured to rest against, separate and keep the large lips and the small lips apart.
[0030] [0030] Conveniently, the vaginal speculum additionally comprises soft fillable material that can be coupled or permanently attached to at least part of the surfaces of the speculum.
[0031] [0031] Preferably, the filling material is located in the proximal base elements.
[0032] [0032] Advantageously, the filling material is located in the separation elements.
[0033] [0033] Conveniently, the vaginal speculum further comprises an absorbent material attachable or permanently attached to at least part of the surfaces of the speculum.
[0034] [0034] Preferably, the absorbent material is coupled or attachable to the interior of the separation elements.
[0035] [0035] Advantageously, the vaginal assembly comprises proximal engagement sections configured to engage the locking element.
[0036] [0036] Conveniently, the coupling sections are located on the base elements.
[0037] [0037] Preferably, the vaginal speculum is configured so that the transverse separation force is adjustable.
[0038] [0038] Advantageously, the vaginal speculum comprises a plurality of engagement sections, so that the transverse separation force created by the locking element can be adjusted by engagement on different engagement sections.
[0039] [0039] Conveniently, the vaginal speculum comprises a plurality of locking elements with different elastic properties, so that the transverse separation force is adjustable with the use of different locking elements.
[0040] [0040] Preferably, the transverse separation force is adjustable by a screw mechanism.
[0041] [0041] Advantageously, the vaginal assembly is configured to support the anterior vaginal wall after insertion into the vagina.
[0042] [0042] Conveniently, the vaginal assembly additionally comprises an element of the anterior vaginal wall configured to support the anterior vaginal wall.
[0043] [0043] Preferably, the anterior vaginal wall element is connected to the distal end of the vaginal assembly, extending in the proximal direction from the distal end, preferably in the form of a tongue, such as a flattened and rounded shape .
[0044] [0044] Advantageously, the anterior vaginal wall element is produced from an elastic material, so that it is configured to support the anterior vaginal wall.
[0045] [0045] Conveniently, the anterior vaginal wall element comprises a depression adapted to be tightened by the user at insertion and removal.
[0046] [0046] Preferably, the anterior vaginal wall element comprises a surface profile adapted to be tightened by the user at insertion and removal.
[0047] [0047] Conveniently, the vaginal assembly is configured to support the pressure exerted by the bladder on the subject's anterior vaginal wall.
[0048] [0048] Preferably, the proximal ends of the separation elements comprise a surface profile adapted to be tightened by the user at insertion and removal.
[0049] [0049] Advantageously, at least one of the proximal ends of the separation elements comprises one or more projections to retain materials for examination or suture.
[0050] [0050] Conveniently, at least one of the proximal ends of the separation elements comprises one or more slits to hold the suture materials,
[0051] [0051] Preferably, the vaginal speculum is manufactured at least partially from an elastic material.
[0052] [0052] Advantageously, the vaginal speculum is manufactured entirely from an elastic material.
[0053] [0053] Conveniently, the vaginal speculum is made from metal or nylon or a plastic material, such as polyethylene (PE), polypropylene (PP), polystyrene (PS) and polyvinyl chloride (PVC).
[0054] [0054] Preferably, at least part of the vaginal assembly surface is coated with a different material than the vaginal assembly material.
[0055] [0055] Advantageously, at least part of the surface of the vaginal assembly is coated with a fluid or gel before or after packaging and before insertion into the vagina.
[0056] [0056] Conveniently, the vaginal speculum is manufactured using injection molding or additive manufacturing.
[0057] [0057] Preferably, the vaginal assembly or the entire speculum is disposable.
[0058] [0058] Advantageously, the speculum is sterilized and is in a sealed package before use.
[0059] [0059] Conveniently, the vaginal speculum is configured to be resiliently elastic, so that the vaginal assembly can be compressed transversely for insertion into the vagina.
[0060] [0060] Preferably, the vaginal assembly is packaged in a compressed and compact condition for insertion into the vagina.
[0061] [0061] Advantageously, the vaginal speculum is configured for coupling additional equipment, such as one or more lights, or one or more cameras or one or more suction tubes.
[0062] [0062] Conveniently, the vaginal speculum additionally comprises one or more permanent or removable pads, such as soft padding and / or fluid absorbent padding.
[0063] [0063] In accordance with a further aspect of the invention, a set of vaginal specula is provided which comprise a series of specula as defined above, wherein said specula are provided in predefined sizes, so that the specula fit adequately to a range of anatomies.
[0064] [0064] In accordance with another aspect of the invention, a method is provided to provide an unobstructed view of at least the posterior part of the vaginal wall during examination and / or suture of a subject after said subject has given birth, in which the method comprises the steps of:
[0065] [0065] inserting a longitudinal vaginal assembly of a vaginal speculum into the subject's vagina, and
[0066] [0066] engaging a locking element in the vaginal assembly so that the vaginal assembly creates a transverse separating force to separate and keep the subject's vaginal walls apart, while providing an unobstructed view of at least the back of the vaginal wall for examination and / or suture of said subject.
[0067] [0067] Preferably, the method further comprises the step of compressing the vaginal assembly transversely before insertion into the vagina.
[0068] [0068] Advantageously, the method further comprises the step of releasing the vaginal assembly from a compressed and compact configuration after insertion into the vagina.
[0069] [0069] Conveniently, the vaginal assembly and the locking element used in the method are the vaginal assembly and the locking element as defined above.
[0070] [0070] In accordance with another aspect of the invention, a method is provided to provide an unobstructed view of at least the posterior part of the vaginal wall during examination and / or suture of a subject after said subject has given birth, in which the method comprises the steps of:
[0071] [0071] inserting a longitudinal vaginal assembly of a vaginal speculum into a subject's vagina, so that the vaginal assembly creates a transverse separation force to separate and keep the subject's vaginal walls apart, providing an unobstructed view of at least the back the vaginal wall for examination and / or suture of said subject.
[0072] [0072] Preferably, the vaginal speculum used in the method described in the previous paragraph is a speculum, as defined in this document.
[0073] [0073] In accordance with an additional aspect of the invention, a kit of parts is provided comprising a vaginal speculum, as described above in the form of a kit of sterile and pre-packaged parts for single use.
[0074] [0074] In accordance with another aspect of the invention, a method is provided for inserting a vaginal speculum into a subject's vagina, wherein the method comprises the steps of providing a vaginal speculum as described above and inserting the distal end of the speculum into the vagina of the subject.
[0075] [0075] Preferably, before insertion, the longitudinal separation elements are compressed transversely against each other, from a resting state to a compressed state.
[0076] [0076] Advantageously, after insertion, the separation elements are released and return from the compressed state to the resting state.
[0077] [0077] In accordance with a further aspect of the invention, a method of suturing vaginal tissue is provided, comprising the steps of:
[0078] [0078] inserting a vaginal speculum as described above into a subject's vagina using the method as described above; and
[0079] [0079] suture a cut in the subject's vaginal tissue.
[0080] [0080] In accordance with another aspect of the invention, a method is provided for making a vaginal speculum as described above through injection molding or additive manufacturing. DEFINITIONS
[0081] [0081] Anterior vaginal wall: frontal wall of the vagina, behind which the subject's bladder and urethra are located.
[0082] [0082] Posterior vaginal wall: rear wall of the vagina, behind which the rectum and anus are located.
[0083] [0083] Lateral vaginal walls: vaginal walls that connect the anterior and posterior walls of the vagina on each side.
[0084] [0084]
[0085] [0085] Distal end: defines the end of the vaginal speculum that is farthest from the doctor during use. In other words, it is the end of the speculum that is first inserted into the subject's vagina during use.
[0086] [0086] “Proximal end: the proximal end defines a part of the speculum that is accessible to the physician during use. DESCRIPTION OF THE DRAWINGS
[0087] [0087] The modalities of the invention, together with its advantages, can be better understood from the detailed description below, taken in conjunction with the attached Figures.
[0088] [0088] Figure 1 is a side view of an embodiment of the vaginal assembly of the vaginal speculum according to the present invention.
[0089] [0089] Figure 2 shows an embodiment of the locking element used for the vaginal speculum in the present invention.
[0090] [0090] Figure 3 is a top view of the vaginal assembly shown in Figure 1.
[0091] [0091] Figure 4 is a front view, that is, a view of the proximal end (from the user's perspective), of the vaginal assembly shown in Figures 1 and 3.
[0092] [0092] Figure 5 shows a front view of the vaginal assembly shown in Figures 1, 3 and 4 with the locking element engaged in the vaginal assembly.
[0093] [0093] Figure 6 is a front view of a second embodiment of the vaginal assembly of the vaginal speculum according to the present invention;
[0094] [0094] Figure 7 is an oblique view of a third embodiment of the vaginal assembly of the vaginal speculum according to the present invention;
[0095] [0095] Figure 8 is a front view of the vaginal assembly shown in Figure 7.
[0096] [0096] Figure 9 shows another modification of the locking element that can be used with the vaginal assembly in Figures 7 and 8.
[0097] [0097] Figure 10 is a front view of the vaginal assembly shown in Figures 7 and 8, with the locking element engaged in the vaginal assembly.
[0098] [0098] Figure 11 is a side view of another embodiment of the vaginal assembly of the vaginal speculum according to the present invention, showing projections and cracks in the separation elements to retain and / or secure suture materials and striations in the separation elements for tighten and compress the speculum at insertion and removal.
[0099] [0099] Figure 12 is a front view of the vaginal assembly shown in Figure 11, in which a depression is provided in the anterior vaginal wall element to tighten and compress the speculum at insertion and removal.
[0100] [0100] Figure 13 is a top view of the vaginal assembly shown in Figures 11 and 12, with grooves on the anterior vaginal wall element to tighten and compress the speculum at insertion and removal. DETAILED DESCRIPTION OF THE INVENTION
[0101] [0101] The first aspect of the present disclosure refers to a vaginal speculum that allows examination and / or suturing at least of the posterior part of the vagina. Preferably, the vaginal speculum provides a clear and unobstructed view of at least the posterior part of the vagina. In one embodiment of the present invention, the vaginal assembly is configured to exert sufficient force on the vaginal walls to keep the walls apart and expose at least the posterior part of the vagina. Advantageously, the vaginal assembly is configured to assume the desired shape on insertion. This can be achieved by adapting the materials and dimensions of the assembly, so that sufficient strength, elasticity and resilience are acquired. In another embodiment, the vaginal speculum further comprises a locking element configured to engage the vaginal assembly to create a transverse separation force at a proximal end of the separation elements to keep the subject's vaginal walls apart. This locking element can be an integral part of the vaginal assembly or can be configured for detachable engagement with the vaginal assembly.
[0102] [0102] In one embodiment, the vaginal assembly and the locking element are shaped so that at least the back of the vaginal tissue is exposed for examination and / or suture when the vaginal assembly is inserted into the vagina and the locking element is engaged in the vaginal assembly. The locking element must therefore be shaped in such a way that it does not obstruct the view and / or access at least to the posterior area of the vagina. This can be accomplished by a wide variety of shapes for the locking element. In one embodiment, the locking element is shaped like an arc or an inverted V. This shape for the locking element may be preferred so that it does not extend in a direct transverse line between the separation elements, which could obstruct the view and / or access to the posterior part of the vagina.
[0103] [0103] The locking element is preferably constructed so that it can exert a force on the vaginal assembly to separate the vaginal walls. In one embodiment, the locking element is predominantly elastic in one or more predefined parts. Here, it is understood that the elastic has the capacity to return to its original length, shape or configuration after being deformed, in which the deformation may refer to stretching, compression or expansion. An elastic material may be able to return or recover its original shape and size spontaneously after deformation. Elastic can also refer to materials that exert a force on their surroundings when deformed, as the material seeks to return to its original shape.
[0104] [0104] The speculum can also be configured to expose at least partially a lateral wall of the vagina. This is achieved, for example, with the use of the speculum in a rotated orientation. The present invention can be used for various types of exams or for suturing or surgery. In one embodiment, the speculum is for use during vaginal suture after the subject has given birth.
[0105] [0105] The vaginal assembly may additionally comprise proximal base elements configured to rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina. An objective of the basic elements is that they can provide the subject with better comfort when the vaginal speculum is inserted into the vagina and provide better protection of the subject's sensitive tissue when in contact with the vaginal speculum. The proximal base elements are, in one embodiment, flattened and curved out of the separation elements, so that they can rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina. In another embodiment, the proximal base elements are flattened and extend transversely, so that they can rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina. The proximal base elements are preferably located at the proximal ends of the separation elements. In addition, the proximal base elements are preferably configured to rest against, separate and keep the large lips and small lips apart.
[0106] [0106] In one embodiment of the present invention, the vaginal assembly comprises proximal engagement sections configured to engage the locking element. The basic elements can also be used for this purpose. Therefore, in another embodiment, the coupling sections are located on the base elements. The vaginal speculum can also be configured so that the transverse separation force is adjustable. In one embodiment, the vaginal speculum comprises a plurality of engagement sections, so that the transverse separation force created by the locking element can be adjusted by engagement in different engagement sections. In another embodiment, the transverse separation force is adjustable by a screw mechanism. The vaginal speculum may also comprise a plurality of locking elements with different elastic properties, so that the transverse separation force is adjustable with the use of different locking elements. In this way, some locking elements are configured to exert a greater force on the surroundings, such as the vaginal assembly when engaged in the vaginal assembly, than other locking elements.
[0107] [0107] In some embodiments, the vaginal assembly is additionally configured to support the anterior vaginal wall after insertion into the vagina. The vaginal assembly can therefore further comprise an anterior vaginal wall member configured to support the anterior vaginal wall. In one embodiment, the anterior vaginal wall element is connected to the distal end of the vaginal assembly, extending proximally from the distal end, and preferably in the shape of a tongue, such as a flattened and rounded shape. The anterior vaginal wall element can be produced from an elastic material, so that it is configured to support the anterior vaginal wall. The anterior vaginal wall element can thus deform at least temporarily when inserted into the vagina, so that it exerts a force on the subject's anterior vaginal wall. In another embodiment, the vaginal assembly is configured to support the pressure exerted by the bladder on the subject's anterior vaginal wall.
[0108] [0108] To facilitate easy and safe insertion and removal of the vaginal assembly, the vaginal assembly advantageously comprises one or more areas adapted to be tightened with one or more fingers. In addition, the areas can be tightened simultaneously with two or more fingers of a single hand, so that the assembly is simple and easy to handle, as well as simple and easy to compress with respect to insertion.
[0109] [0109] For example, the front wall element may comprise a depressed area 32 as shown in Figure 11, configured to be gripped by a user's finger. More advantageously, the depressed area, or the depression, is placed centrally within the front wall element, so that when the assembly is tightened by the user for insertion or removal, the tightening generates a symmetrical distribution of the tightening force .
[0110] [0110] The depressed area may additionally comprise a surface profile or surface roughness, such as a corrugated or fluted surface, as shown in Figure 11, to further facilitate and simplify tightening.
[0111] [0111] In a disclosure mode, the anterior vaginal wall element comprises a depression adapted to be tightened by the user at insertion and removal. In another embodiment, the depression is placed centrally within the anterior wall element. In an additional embodiment, the anterior vaginal wall element comprises a surface profile adapted to be tightened by the user at insertion and removal.
[0112] [0112] For example, in some embodiments with an anterior vaginal wall element, a depression is included in the center of the flat, rounded tongue shape of the anterior wall element. This depression allows the user to squeeze the anterior vaginal wall element with a finger, which can be used to press the anterior vaginal wall element downwards to facilitate insertion and removal. The anterior vaginal wall element can be grooved to simplify tightening for insertion and removal.
[0113] [0113] Advantageously, one or both of the proximal ends of the separation elements comprise areas adapted to be clamped with one or more fingers. For example, a portion of the proximal ends of both separation elements may comprise a surface profile or surface roughness 33, as shown in Figure 11, adapted to be tightened by the user. In addition, when both ends comprise a surface profile, the vaginal assembly is even more easily compressed laterally by two or more fingers of a single hand, so that the compression can be directed to the centroid or geometric center of the assembly.
[0114] [0114] In some embodiments, the separation elements of the vaginal assembly are striated to simplify the tightening by the user at insertion and removal. The surface profile can optionally comprise grooves, forming one or more concentric circular grooves or parts of circular grooves, so that they are additionally adapted to be pressed with a finger, as shown in Figure
[0115] [0115] In a disclosure mode, the proximal ends of the separation elements comprise a surface profile adapted to be tightened by the user at insertion and removal.
[0116] [0116] Advantageously, the vaginal speculum in accordance with the present disclosure can further facilitate the suture and / or examination process, for example, by facilitating the handling of suture materials or examination devices. For example, the proximal end of one or both of the separation elements may comprise protrusions, projections and / or cracks to retain and / or secure the materials used for suturing or examination. For example, a protrusion or projection 34 can comprise one or more slits, as shown in Figure 11. The protrusion is advantageously adapted to be used to retain a suture material, such as a thread, and the slit is advantageously adapted to be used to attach or fix a suture material, such as a thread. For example, a thread can be placed over the projection and wound around a slit in the same way as a sewing thread on a bobbin. Thus, in some embodiments, the proximal ends of one or both of the separation elements are provided with projections to retain materials for examination or suture. In some embodiments, the proximal ends of one or both of the separation elements are provided with slots to securely hold the suture materials.
[0117] [0117] In a disclosure modality, at least one of the proximal ends of the separation elements comprises one or more projections to retain materials for examination or suture. In another and additional embodiment, at least one of the proximal ends of the separation elements comprises one or more slots for securing suture materials.
[0118] [0118] The material for the vaginal speculum must be chosen to match the desired properties for the speculum. In one embodiment, the vaginal speculum is manufactured at least partially from an elastic material. In another embodiment, the vaginal speculum is manufactured entirely from an elastic material. The vaginal speculum can, in some modalities, be manufactured from metal or nylon or a plastic material, such as polyethylene (PE), polypropylene (PP), polystyrene (PS) and polyvinyl chloride (PVC). Depending on the speculum's thickness and design, these materials can be designed to provide more or less flexible properties. The speculum can also be manufactured from a combination of the listed materials. Manufacturing techniques that can be used for the vaginal speculum include injection molding and additive manufacturing.
[0119] [0119] In one embodiment, at least part of the vaginal assembly surface is coated with a different material than the vaginal assembly material. In one example, the vaginal assembly is manufactured mainly from a material with elastic and / or resilient properties, which is then at least partially coated with a second material for softness, smoothness, insulation or to make the assembly easier to handle or less traumatic for the patient. The coating can provide a smoother surface or reduced friction, which also improves comfort and reduces trauma to the subject. At least part of the surface of the vaginal assembly can also be coated with a fluid or gel before or after packaging and before insertion into the vagina. This can be for lubricating and / or anesthetic purposes, so that the speculum causes less discomfort during insertion and use.
[0120] [0120] In one embodiment of the present invention, the speculum additionally comprises a soft filler material that can be coupled or permanently attached to at least part of the surfaces of the speculum. Again, this can provide better protection for sensitive tissue, thereby improving patient comfort and making the experience less traumatic. The filling material can be located on the proximal base elements and / or on the separation elements. For the filling material in the separation elements, it is additionally advantageous that the material is smooth, slippery and offers low friction against the fabric.
[0121] [0121] The vaginal speculum may additionally comprise an absorbent material attachable or permanently attached to at least part of the surfaces of the speculum. In one embodiment, the absorbent material is coupled or coupled to the interior of the separation elements. The interior of the separation elements refers to the part of the surface of the separation elements facing away from the vaginal tissue after the speculum is inserted into the vagina. This can act as an addition to or a replacement for a suction device. The absorbent material can be coupled or attachable using an adhesive or by sliding the absorbent material into the slots provided in the speculum. The absorbent material can also be mounted on another element that is trapped inside the separation element, for example, by sliding it into cracks in the separation elements.
[0122] [0122] The vaginal speculum can be reusable by cleaning and sterilizing the speculum after use. Preferably, the currently disclosed vaginal assembly or entire speculum is disposable. In addition, the speculum is preferably sterile and is in a sealed package before use. This will decrease the risk of infection after using the speculum. In one embodiment, the vaginal assembly is configured to be resiliently elastic, so that the vaginal assembly can be compressed transversely for insertion into the vagina. Before being inserted into the vagina, the vaginal assembly can thus be compressed, either manually or with the use of a tool. The vaginal assembly is then inserted into the vagina and the compression force is released so that the vaginal assembly separates transversely and keeps the vaginal walls apart. In another embodiment, the vaginal assembly is packaged in a compressed and compact condition for insertion into the vagina.
[0123] [0123] In some situations, it may be advantageous and practical to attach other equipment to the speculum when performing examinations, sutures or surgeries on the subject. Therefore, the vaginal speculum is in a mode configured for coupling to additional equipment, such as one or more lights, or one or more cameras or one or more suction tubes. In another embodiment, the vaginal speculum further comprises one or more permanent or removable pads, such as soft padding and / or fluid absorbent padding.
[0124] [0124] The third aspect of the invention relates to a method for providing an unobstructed view of at least the posterior part of the vaginal wall with the use of a vaginal assembly and a locking element. In one embodiment, the method further comprises the step of compressing the vaginal assembly transversely before insertion into the vagina. The speculum can be manufactured from at least a partially flexible material, in which case the assembly must be compressed transversely for insertion into the vagina. In another embodiment, the method further comprises the step of releasing the vaginal assembly from a compressed and compact configuration after insertion into the vagina. For a vaginal assembly made from an elastic material, the assembly will then exert a transverse force on the vaginal walls and, thus, separate and keep the vaginal walls apart, so that at least the posterior part of the vagina is exposed. The method can, moreover, be carried out using the vaginal assembly and the locking element according to the first aspect of the present invention.
[0125] [0125] However, the vaginal speculum is capable of exerting sufficient force on the vaginal walls to keep the walls apart without using a locking latch. Therefore, in all modalities, it is envisaged that the speculum will not have engagement sections to engage a locking mechanism.
[0126] [0126] As detailed above, the vaginal speculum may comprise an anterior vaginal wall element that is connected at the distal end of the vaginal assembly and extends proximally from the distal end to support the anterior vaginal wall.
[0127] [0127] As with the longitudinal separation elements, the anterior vaginal wall element can also be manufactured from at least a partially flexible material. When the separation elements are compressed transversely for insertion into a subject's vagina, the vaginal wall element can also be compressed towards the separation elements. The distal end of the speculum can then be advanced into the subject's vagina in a position so that the anterior vaginal wall element is disposed facing the anterior wall of the vagina.
[0128] [0128] When advancing to the desired depth within the vagina, the separation elements and the vaginal wall element can be released in order to revert from the compressed state to its original uncompressed state. In doing so, the separating elements keep the side walls of the vagina apart and the anterior vaginal wall element supports and exerts pressure on the anterior wall of the vagina. In addition to providing a support function, the anterior vaginal wall element can also act to rest behind the subject's pubic bone when it is in the vagina and thus act as an anchor to hold the speculum in place during use.
[0129] [0129] This speculum configuration comprising an anterior vaginal wall element has a specific advantage in providing a clearer and less obstructed view of the posterior section of the vagina, in particular the perineum, which is where most cuts occur during childbirth. DETAILED DESCRIPTION OF THE DRAWINGS
[0130] [0130] Figure 1 shows an embodiment of the vaginal assembly of the vaginal speculum in accordance with the present invention. In this modality, the speculum consists of two parts, a vaginal assembly 1 and a locking element (not shown in this Figure). The vaginal assembly 1 comprises two longitudinal separation elements 2, 3 and each with a proximal base element 4, 5 with engagement sections 6, 7 for engaging the locking element in the vaginal assembly. The longitudinal separation elements 2, 3 are connected to the distal tip 9. In this embodiment, the vaginal assembly additionally comprises an anterior vaginal wall element 8 to support the anterior vaginal wall.
[0131] [0131] Figure 2 illustrates an embodiment of a locking element 10 for use with the vaginal assembly of Figure 1. The locking element consists of two arms 11, 12 connected at one end 13, so that they are shaped of an inverted V. The other ends 14, 15 of the arms are configured to engage the vaginal assembly.
[0132] [0132] Figure 3 shows a top view of the vaginal assembly of Figure 1. This view shows that the separation elements 2, 3 are further apart at the proximal end than at the distal end. The material for the vaginal assembly can be flexible, so that the assembly can be compressed transversely to a compact state before insertion into the vagina. The separation elements 2, 3 can then at least partially separate the vaginal walls and keep them apart when the compressive force is released.
[0133] [0133] Figure 4 is a front view, that is, a view of the proximal end (from the user's perspective), of the vaginal assembly shown in Figures 1 and 3. The vaginal assembly 1 in this embodiment comprises two engaging sections 6, 7 on each base element 4, 5, so that the separating force can be adjusted by engaging the locking element in different engaging sections.
[0134] [0134] Figure 5 shows a front view of the vaginal assembly shown in Figures 1, 3 and 4 with the locking element of Figure 2 engaged in the vaginal assembly. The ends 14, 15 of the locking element 10 are engaged with the locking sections 6, 7 of the vaginal assembly, so that a transverse separating force is exerted by the locking element on the vaginal assembly.
[0135] [0135] Figure 6 is another modality of vaginal assembly. This modality comprises two separation elements for each side, so that a total of four separation elements are connected to the distal end. The two left separating elements 16 are connected to a base element on the left side and, correspondingly, the two right separating elements 17 are connected to a base element on the right side. Vaginal assemblies with multiple separation elements can, in some cases, be advantageous and provide less discomfort to the subject. In addition, the separation elements are shaped to provide additional separation pressure. The separation elements initially extend in a proximal direction from the distal tip end. The left and right separation elements then curve in opposite directions from each other, so that the distance between them becomes greater and then they curve back, so that they are parallel or almost parallel. Finally, the separation elements curve so that the distance between them increases at the proximal end where the base elements are connected. This speculum design provides additional separating force over areas where the distance between the separating elements is large, which can be advantageous to provide a clear and unobstructed view.
[0136] [0136] Figure 7 further shows another embodiment of the vaginal assembly comprising two longitudinal separation elements 18, 19 connected at the distal tip end 20 and each with a proximal base element 21, 22. The vaginal assembly additionally comprises an element anterior vaginal wall 23 to support the anterior vaginal wall. A clamp 24 is provided on the anterior vaginal wall element to pull the anterior vaginal wall element down to facilitate insertion and removal of the vaginal assembly.
[0137] [0137] Figure 8 is a front view of the vaginal assembly in Figure 7. The figure shows an engagement section 25, 26 on each of the base elements 21, 22 for engagement with a locking element. The shape of the separation elements is similar to that of Figure 6, so that the speculum provides additional separation force in areas where the separation elements are separated by a great distance.
[0138] [0138] Figure 9 shows an embodiment of a locking element for use with the vaginal assembly shown in Figures 7 and 8. This embodiment of the locking element is in the shape of an arc or an inverted U and comprises two side elements 27, 28 connected at the top by a central element 29. Each lower end 30, 31 of the side arms is configured to engage the engagement sections in the vaginal assembly.
[0139] [0139] Figure 10 shows the locking element of Figure 9 engaged in the vaginal assembly shown in Figures 7 and 8. The locking element engages the engaging sections in the vaginal assembly at an angle so that the locking element is engaged in safe way in vaginal assembly with a low risk of disengagement during speculum use. The Figure also shows the shape of the separation elements, as described in Figure 8, to provide additional separation force.
[0140] [0140] Figure 11 shows a modality of vaginal assembly, in which the assembly is configured to assume the desired shape during insertion, adapting to the materials and dimensions of the assembly. The vaginal assembly is shown in a side view and comprises several areas adapted to be squeezed by one or more fingers. The front wall element comprises a depressed and grooved area 32 centrally placed on the front wall element, and the proximal ends of the separation elements comprise concentric circular grooves 33 adapted to be clamped with one or more fingers. Preferably, the areas adapted to be tightened are squeezed by the fingers of a single hand, so that the assembly is easily handled and compressed, thus facilitating insertion and removal of the speculum. Compression can be directed to the centroid or geometric center of the assembly, thus facilitating the insertion and removal of the speculum. The built-in assembly further comprises projections and slits 34 at the proximal ends of the separation elements for retaining and / or securing suture materials.
[0141] [0141] Figure 12 is a front view of the vaginal assembly shown in Figure 11, in which a depression is provided in the anterior vaginal wall element to tighten and compress the speculum at insertion and removal.
[0142] [0142] Figure 13 is a top view of the vaginal assembly shown in Figures 11 and 12, with striations on the anterior vaginal wall element to tighten and compress the speculum at insertion and removal.

权利要求:
Claims (40)
[1]
1. Vaginal speculum characterized by the fact that it comprises: - a vaginal assembly comprising at least two longitudinal separation elements connected at a distal end for insertion into a subject's vagina, in which the vaginal speculum is configured to maintain the vaginal walls of the subject, thus allowing the examination and / or suture at least of the posterior part of the vaginal tissue.
[2]
2. Vaginal speculum according to claim 1, characterized in that the vaginal assembly additionally comprises an anterior vaginal wall element configured to support the anterior vaginal wall.
[3]
3. Vaginal speculum, according to claim 2, characterized by the fact that the anterior vaginal wall element is connected at the distal end of the vaginal assembly, extending proximally from the distal end.
[4]
4. Vaginal speculum according to claim 2 or 3, characterized by the fact that the anterior vaginal element is in the shape of a tongue, such as a flattened and rounded shape.
[5]
Vaginal speculum according to any of claims 2 to 4, characterized in that the anterior vaginal wall element is produced from an elastic material, so that it is configured to support the anterior vaginal wall.
[6]
6. Vaginal speculum, according to any of the preceding claims, characterized by the fact that the speculum is configured to expose at least partially a lateral wall of the vagina.
[7]
7. Vaginal speculum, according to claim 6, characterized by the fact that the lateral wall of the vagina is at least partially exposed with the use of the speculum in a rotated orientation.
[8]
8. Vaginal speculum, according to any of the preceding claims, wherein the speculum is characterized by the fact that it is for use during vaginal suture after the subject has given birth.
[9]
9. Vaginal speculum according to any one of the preceding claims, characterized in that the vaginal assembly additionally comprises proximal base elements configured to rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina.
[10]
10. Vaginal speculum according to claim 9, characterized by the fact that the proximal base elements are flattened and bend outward from the separation elements, so that they can rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina.
[11]
11. Vaginal speculum, according to claim 9, characterized by the fact that the proximal base elements are flattened and extend transversely, so that they can rest on the skin outside the vagina after the vaginal assembly has been inserted into the vagina.
[12]
Vaginal speculum according to any one of claims 9 to 11, characterized in that said proximal base elements are located at the proximal ends of the separation elements.
[13]
13. Vaginal speculum according to any one of claims 9 to 12, characterized by the fact that said proximal base elements are configured to rest, separate and retain the labia majora and labia minora.
[14]
Vaginal speculum according to any one of the preceding claims, characterized in that it additionally comprises soft fillable material that can be permanently coupled or permanently coupled to at least part of the speculum surfaces.
[15]
15. Vaginal assembly, according to claim 14, characterized by the fact that the filling material is located in the proximal base elements.
[16]
16. Vaginal assembly, according to claim 14, characterized by the fact that the filling material is located in the separation elements.
[17]
17. Vaginal specimen according to any of the preceding claims, characterized in that it additionally comprises an absorbent material that can be coupled or permanently coupled to at least a part of the speculum surfaces.
[18]
18. Vaginal assembly according to claim 17, characterized by the fact that the absorbent material is coupled or attachable to the interior of the separation elements.
[19]
19. Vaginal speculum, according to any of the preceding claims, characterized by the fact that the vaginal assembly is configured to support the anterior vaginal wall after insertion into the vagina.
[20]
20. Vaginal speculum, according to any of the previous claims, characterized by the fact that the vaginal assembly is configured to support the pressure exerted by the bladder on the subject's anterior vaginal wall.
[21]
21. Vaginal speculum, according to any one of the preceding claims, wherein the vaginal speculum is characterized by the fact that it is manufactured at least partially from an elastic material.
[22]
22. Vaginal speculum, according to any of the preceding claims, wherein the vaginal speculum is characterized by the fact that it is manufactured entirely from an elastic material.
[23]
23. Vaginal speculum according to any one of the preceding claims, wherein the vaginal speculum is characterized by the fact that it is manufactured from metal or nylon or a plastic material, such as polyethylene (PE), polypropylene (PP), polystyrene (PS) and polyvinyl chloride (PVC).
[24]
24. Vaginal speculum according to any one of the preceding claims, characterized in that at least part of the surface of the vaginal assembly is coated with a different material than the material of the vaginal assembly.
[25]
25. Vaginal speculum according to any one of the preceding claims, characterized by the fact that at least part of the surface of the vaginal assembly is coated with a fluid or gel before or after packaging and before insertion into the vagina.
[26]
26. Vaginal speculum, according to any of the preceding claims, wherein the speculum is characterized by the fact that it is manufactured using injection molding or additive manufacturing.
[27]
27. Vaginal specimen, according to any of the preceding claims, characterized by the fact that the vaginal assembly or the entire speculum is disposable.
[28]
28. Vaginal speculum, according to any of the preceding claims, in which the speculum is characterized by the fact that it is sterilized and is in a sealed package before use.
[29]
29. Vaginal speculum according to any one of the preceding claims, characterized in that it is configured to be resiliently elastic, so that the vaginal assembly can be compressed transversely for insertion into the vagina.
[30]
30. Vaginal speculum according to any one of the preceding claims, characterized in that the vaginal assembly is packaged under a compressed and compact condition for insertion into the vagina.
[31]
31. Vaginal speculum according to any one of the preceding claims, characterized by the fact that it is configured for the attachment of additional equipment, such as one or more lights, or one or more cameras, or one or more suction tubes.
[32]
32. Vaginal speculum according to any one of the preceding claims, characterized in that it additionally comprises one or more permanent or removable pads, such as soft padding and / or fluid absorbent padding.
[33]
33. Set of vaginal specula characterized by the fact that it comprises a series of specula according to any one of claims 1 to 32, wherein said specula are provided in predefined sizes, so that the specula are properly adjusted to a series of anatomies.
[34]
34. Parts kit characterized by the fact that it comprises a vaginal speculum, according to any one of claims 1 to 32, in the form of a sterile and pre-packaged parts kit for single use.
[35]
35. Method for inserting a vaginal speculum into a subject's vagina, wherein the method is characterized by the fact that it comprises the steps of providing a vaginal speculum according to any one of claims 1 to 32, and inserting the distal end of the speculum in the subject's vagina.
[36]
36. Method according to claim 35, characterized in that, prior to insertion, the longitudinal separating elements are compressed transversely against each other, from a resting state to a compressed state.
[37]
37. Method according to claim 36, characterized by the fact that, after insertion, the separation elements are released and return from the compressed state to the resting state.
[38]
38. Method for suturing vaginal tissue characterized by the fact that it comprises the steps of: inserting a vaginal speculum, according to any one of claims 1 to 32, into a subject's vagina, using the method, according to any one claims 35 to 37; and suture a cut in the subject's vaginal tissue.
[39]
39. Method for providing an unobstructed view of at least the posterior part of the vaginal wall during examination of a subject after the subject gives birth characterized by the fact that it comprises the step of: inserting a vaginal speculum, according to any of the claims 1 to 32, in a subject's vagina, using the method according to any one of claims 35 to 37.
[40]
40. Method for making a vaginal speculum according to any one of claims 1 to 32, characterized in that it is performed by means of injection molding or additive manufacturing.

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JP2021502206A|2021-01-28|

EP3706615A1|2020-09-16|

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法律状态:
2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

申请号 | 申请日 | 专利标题

EP17200995|2017-11-10|

EP17200995.3|2017-11-10|

EP18176417.6|2018-06-07|

EP18176417|2018-06-07|

PCT/EP2018/080842|WO2019092222A1|2017-11-10|2018-11-09|Vaginal speculum|

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