WO2020011616A1 - A vacuum-based tenaculum - Google Patents

A vacuum-based tenaculum Download PDF

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Publication number
WO2020011616A1
WO2020011616A1 PCT/EP2019/067847 EP2019067847W WO2020011616A1 WO 2020011616 A1 WO2020011616 A1 WO 2020011616A1 EP 2019067847 W EP2019067847 W EP 2019067847W WO 2020011616 A1 WO2020011616 A1 WO 2020011616A1
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WO
WIPO (PCT)
Prior art keywords
spring
tenaculum
vacuum
vacuum tank
opening
Prior art date
Application number
PCT/EP2019/067847
Other languages
French (fr)
Inventor
Taina TJÄDER
Mikael Stolt
Petri Perälä
Jari Riski
Kimmo Laaksonen
Original Assignee
Bayer Oy
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Oy filed Critical Bayer Oy
Publication of WO2020011616A1 publication Critical patent/WO2020011616A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/64—Containers with integrated suction means
    • A61M1/66—Pre-evacuated rigid containers, e.g. Redon bottles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/81—Piston pumps, e.g. syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/81—Piston pumps, e.g. syringes
    • A61M1/815—Piston pumps, e.g. syringes the barrel serving as aspiration container, e.g. in a breast pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/4241—Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407—Ratchet means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473—Distal part, e.g. tip or head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00561—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A61B2017/308—Surgical pincettes without pivotal connections holding by means of suction with suction cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A61B2017/4225—Cervix uteri
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0813—Accessories designed for easy sterilising, i.e. re-usable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/14—Female reproductive, genital organs
    • A61M2210/1433—Uterus

Definitions

  • the present invention relates to a vacuum-based tenaculum, comprising a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • a tenaculum is a medical instrument, usually classified as a type of forceps. It consists of a slender sharp-pointed hook attached to a scissor-like handle and is used mainly in surgery for seizing and holding parts.
  • One purpose of the tenaculum is to grab at the vaginal fornix before insertion of an intrauterine system (IUS), or for other gynaecological procedures, and to pull back gently to straighten the uterus.
  • IUS intrauterine system
  • the uterus is typically in flexion towards cervix and it must be straightened to be able to enter the uterine cavity with instruments, or for insertion of the IUS.
  • tenaculum based on vacuum for gynaecological use are known in the prior art.
  • the vacuum is either provided from an outside source (a separate vacuum pump, for example), or the handle of the device comprises a hand-held vacuum pump.
  • the handle of the device comprises a hand-held vacuum pump.
  • no precise description of such hand-held vacuum pumps seems to be available, a syringe mechanism being the only concrete example given in the prior art.
  • document WO 2016/0923458 presents a tenaculum comprising a suction module and a vacuum system.
  • the vacuum system comprises a vacuum reserve source and a support of the vacuum reserve source, that cooperate to form a pump that can be manually activated by a reciprocal sliding motion of the vacuum reserve source within the support.
  • Document WO 2016/018938 discloses a similar tenaculum, also comprising a vacuum source in the handle.
  • the document mentions, as a practical embodiment, a syringe mechanism for creating the vacuum.
  • document US 2012/0283595 discloses a tenaculum comprising a hand-held vacuum pump, without however giving any further indication on how said pump is construed. It is thus not possible to evaluate the practicality of these vacuum pumps, as the prior art does not seem to give any indication how such hand- held vacuum pumps are to be operated. For example, it is not apparent how the devices could be used with only one hand.
  • WO2013/082452 discloses an apparatus for inserting a device into the uterus.
  • the apparatus contains also a suction assembly which can be used as a tenaculum that provides temporary attachment to the cervix through vacuum/suction mechanism.
  • a spring is used in connections with the vacuum creating mechanism. However, in this device the spring is used to release and not to generate the vacuum. Creation of the vacuum in this reference occurs by moving a handle. This movement can shift the vacuum tip (suction head), which could lead to a leakage between the suction head and the cervix tissue.
  • WO2017/089982 discloses a hemorrhoid treatment device. Here a vacuum is used to aspirate the hemorrhoid tissue for deploying the ligature on the neck of the hemorrhoid tissue.
  • WO2014/205351 discloses an apparatus with dilation members.
  • the dilation members should facilitate the insertion of an intrauterine system into the uterus.
  • this document does not give any indication on how the vacuum is generated and the vacuum pump is construed.
  • one object of the invention is to provide a tenaculum that is cost-effective to manufacture as well as easy, reliable and light to use, even with one hand . It is a further object of the invention to provide a tenaculum that is reliable in that the amount of vacuum obtained is constant at each application . It is furthermore an object to provide a tenaculum that can be either for single use or for multiple uses. Naturally, the tenaculum needs to be sterilisable. It is especially an object of the invention to provide a tenaculum, even if for single use (i.e. for a single insertion of an IUS, for a single patient), wherein the vacuum pump can be easily reloaded if the first attempt of using it is not satisfactory.
  • the present description relates to a tenaculum comprising a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the vacuum pump comprises - a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
  • an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring; and - a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening .
  • the spring is arranged to move the piston head .
  • FIG. 1A-1D illustrate a tenaculum according to an embodiment.
  • Fig. 2 illustrates a cross-sectional view of the tenaculum of Fig. 1.
  • Fig. 3 illustrates an exploded view of the tenaculum of Fig. 1.
  • Fig. 4A-4D illustrate a tenaculum according to an embodiment.
  • Fig. 5 illustrates a cross-sectional view of the tenaculum of Fig. 4.
  • Fig. 6A-6B illustrate a tenaculum according to an embodiment.
  • Fig. 7 illustrates a cross-sectional view of the tenaculum of Fig. 6.
  • Fig. 8A-8B illustrate a tenaculum according to an embodiment.
  • Fig. 9 illustrates a cross-sectional view of the tenaculum of Fig. 8.
  • Fig. 10 illustrates a cross-sectional view of a tenaculum according to an embodiment.
  • Fig. 11A-11C illustrate cross-sectional views of a tenaculum according to an embodiment.
  • Fig. 12A-12D illustrate a tenaculum according to a further embodiment
  • Fig. 13A-13C illustrate a cross-sectional view of the tenaculum of Fig. 12A-12D.
  • Fig. 14A-1 illustrates an exploded view of the tenaculum of Fig. 13.
  • Fig. 14B shows details of Fig. 14A namely the piston head 13 with the seal 14 and the screw anchor 82 which ensures a firm connection between the piston head 13 and the axle 15.
  • Fig. 15A illustrates the pressure (vacuum) release mechanism with the cover which exposes the air inlet opening in detail.
  • FIG. 15B-15C illustrate a cross sectional view of Figure 15A. DETAILED DESCRIPTION OF THE INVENTION
  • a typical tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the suction head as discussed below, can be any suitable suction head, for example as known from a prior art document mentioned above. This suction head is connected to a suction tube.
  • the suction tube is also as is known in the prior art, typically a relatively thin, hollow tube. It can be made of plastic or metal, wherein plastic is preferred.
  • the inner diameter of the suction tube can be for example 2- 5 mm, its outer diameter for example 3-6 mm.
  • the handle part is designed such that it can be easily handled, i.e. it has a size and shape that is suitable typically for handling with one hand.
  • the handle comprises a vacuum pump, which is typically at least partially arranged inside the handle. It will be explained below in more detail in which cases the vacuum pump is inside the handle and in which cases it may be partially outside the handle.
  • the vacuum pump comprises a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening.
  • the suction tube may thus extend partially inside the handle part in case the vacuum tank is not directly arranged at a first end of the handle part.
  • the suction tube is naturally connected to both the suction head and the first opening of the vacuum tank in an airtight manner, known as such for a person skilled in the art.
  • the vacuum tube tip can be manufactured as an individual component or it can be an overall part of the vacuum tank.
  • first ends are meant the distal ends of the device, i.e. the ends that are further away from the user when the tenaculum is used.
  • the second ends are the proximal ends, i.e. the ends that are closer to the user when the tenaculum is used.
  • vacuum and under-pressure are used interchangeably. Indeed, the pressure within the vacuum pump is naturally not a full vacuum, i.e. the vacuum tank is not completely devoid of air. Instead, a pressure below atmospheric pressure, i.e. an under-pressure is created within the pressure tank.
  • the under-pressure can be for example of the order of 0.2-0.5 bar in the vacuum tank, when compared to atmospheric pressure, i.e. the pressure within the vacuum tank is for example 0.2- 0.5 bars below the atmospheric pressure or in other words the pressure in the vacuum tank is 0.5 to 0.8 bar.
  • the term vacuum is thus used in the same sense as in the prior art.
  • the vacuum pump further comprises a spring and means for compressing the spring.
  • the spring is made of a suitable material, most typically of metal. It has a spring constant that is suitable for the present purpose, for example 0.7 N/mm.
  • the spring is arranged to move the piston head.
  • the means for compressing the spring is arranged in a manner that it can compress the spring, typically such that the spring is compressed towards the first end of the handle.
  • the means for compressing the spring is discussed in more detail below.
  • the present tenaculum has the advantage, that it can easily and safely be used with only one hand.
  • the vacuum pump further comprises a piston.
  • the piston comprises a piston head moveably arranged within the vacuum tank; an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring; and a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening.
  • the piston head is arranged to move within the vacuum tank, from its first end towards its second end and vice versa.
  • the piston head is also equipped with a pressure seal, which allows an airtight separation of the vacuum tank into two parts, by the piston head.
  • the piston head when moved from the first end of the vacuum tank towards the second end of the vacuum tank creates an under-pressure within the vacuum tank, when the tenaculum is in place and the suction head is arranged in contact with the vaginal fornix and no air can thus enter the vacuum tank via the suction head and the suction tube.
  • the piston also comprises an axle, the first end of which is connected to the piston head and the second end of which is connected to the means for compressing the spring.
  • the means for compressing the spring can thus be for example a solid cylinder or a button.
  • the means for compressing the spring can either be such that when the spring is in its uncompressed state, the means for compressing the spring is mostly outside the handle and it is pushed at least mainly to the inside of the handle when the spring is compressed.
  • the present tenaculum is thus a mechanical single- or multiple-use small-sized device, where the forceps-type tenaculum is replaced by a suction tenaculum that works using a vacuum (i.e. an under-pressure).
  • the vacuum is generated mechanically without any external vacuum source.
  • the tenaculum can be designed to fit to most cervix anatomies and to be compatible with the environmental conditions at the cervix tip or vaginal fornix (dry, wet, tissue surface and elasticity, chemicals and medications typically used during gynecological procedures).
  • the vacuum can be re-applied if lost and it is possible to release it at any time of the procedure.
  • the pressure reduction in the tenaculum can be adjusted to a desired level in some embodiments, as discussed below.
  • the tenaculum comprises a spring chamber, wherein the spring is arranged within the spring chamber and the axle of the piston is arranged to extend to the spring chamber via the second opening of the vacuum tank.
  • the spring chamber is typically arranged along the same axis as the vacuum tank and next to it.
  • the means for compressing the spring may be arranged to enter the spring chamber at least partially when the spring is compressed.
  • the spring is arranged within the vacuum tank.
  • the spring is arranged around the axle of the piston, i.e. the axle is typically in the centre of the spring, when the spring is in its compressed state.
  • a volume reducer is also arranged within the vacuum tank. This volume reducer is connected to the piston head, on an opposing side of it with respect to the axle of the piston, and typically has a cylindrical shape and fitted inside the spring.
  • the spring may be a compression spring or a conical compression spring. In case a conical compression spring is used, a volume reducer is typically not required.
  • the tenaculum especially its handle part, naturally may comprise any other structures that are required, such as reinforcing structures and even empty space if needed in order to achieve a suitable shaped handle part.
  • the means for compressing the spring may be such that they are directly pushed in the longitudinal direction of the tenaculum, thus pushing the spring manually.
  • the means for compressing the spring may comprise suitable parts, such as cogwheels, allowing the spring to be compressed with less force.
  • the handle part may have a length that is 10-25 cm, for example about 20 cm, and its diameter may be approximately 2 cm. It may also comprise a partial sleeve in which the means for compressing the spring is arranged to move.
  • the means for compressing the spring is exposed and from the other side, it is protected by the partial sleeve. This protects also the user's hand when the spring is released (and the means for compressing the spring is typically pushed back to its original position). Similarly, the user's hand does not hinder the movement of the means for compressing the spring.
  • the spring when in compressed position, can be maintained in this compressed position manually, i.e. by keeping pushing the means for compressing the spring or in another manner manually keeping the position.
  • the tenaculum may comprise means for releasably locking the spring in its compressed position and means for releasing the spring for its compressed position. This means may be the same, i.e. the means for releasing the spring can be integrated with the means for locking the spring (or vice versa) or they may be separate means.
  • the axle of the piston is provided with notches configured to cooperate with the means for releasably locking the spring and/or with the means for releasing the spring.
  • the notches may be arranged regularly along the length of the axle or they may be arranged only intermittently or there may be only one or two such notches.
  • the means for locking the spring and/or the means for releasing the spring may be composed of a small locking/releasing spring and a button.
  • the button may have a cylindrical or a cubic form and it may comprise an opening throughout it, so that it can be arranged to surround the axle of the piston.
  • the locking/releasing spring can be arranged underneath the button, and the button would then extend to the outside of the handle part.
  • the spring underneath the button allows the button to move downwards, thus releasing the notch of the axle from the opening in the button, and the spring is free to move.
  • the arrangement can be such that when the spring is compressed, the means for locking the spring in its compressed position can be automatically activated, and when the user is ready (i.e. the tenaculum is properly positioned and the suction head is in its place), the spring is released by pressing the button.
  • the means for releasing the spring is arranged to be set at least two different positions to create at least two different levels of under-pressure to the suction tube and the suction head.
  • This may be arranged such that notches are arranged in the axle, and these notches (or similar) allow setting the spring at different positions when preparing to use the tenaculum.
  • the user may action the means for compressing the spring (typically by pushing it) to an intermediate position between the position where the spring is uncompressed and the position where the spring is fully compressed. There may be one, two, three, four, five or even more such intermediate positions, typically thus one, two, three, four, five or more notches in the axle.
  • the user has to decide before positioning the tenaculum which vacuum would be required (less or more of under- pressure). If it is decided to start with a light vacuum (a small under- pressure), it is possible to press in the means for compressing the spring only up to a first or second notch. If it turns out that the vacuum is not strong enough to hold the cervix, the user may have a second try and press in the means further, to a third or fourth notch, or until the spring is completely compressed. In a preferred embodiment of the inventions there is only one notch in the axle, which holds the spring in the fully compressed position.
  • the handle part may be equipped with several button locks (as described above), so that the level of under-pressure used during the procedure can be adjusted to a desired level. This adjustment can be done before the operation is started, i.e. during the compression of the spring, or it may be done during the operation.
  • the vacuum tank may comprise an air inlet opening, covered by a moveable cover.
  • This air inlet opening is in gas communication with outside of the tenaculum (i.e. with atmospheric surroundings), and it is covered by a moveable cover.
  • the air inlet opening of the vacuum tank is naturally in gas connection with a respective opening in the handle part.
  • the cover is, when covering the air inlet opening, airtight, i.e. no air can enter the vacuum tank via this air inlet. Only after the operation is finished and the tenaculum is to be removed, the cover is moved to expose the air inlet opening, to allow air to enter the vacuum tank and thus to release the suction head from the tip of the fornix.
  • the cover may for example be in the form of a ring moveably arranged on the handle part.
  • the ring may be moved forward (towards the first end of the handle part) or backwards (towards the second end of the handle part) to expose the air inlet openings of the handle part and the vacuum tank to outside air.
  • the air inlet opening might be on the cylinder wall of the vacuum tank or alternatively on the front surface (in this application also referred to as vacuum tube tip) of the cylinder wall (for details see Fig. 15B and 15C).
  • the cover can be in the form of a slider, which operates the tip lock which seals the air inlet opening on the front surface. It is advantageous if a seal (ring or tape) is attached to the front surface of the cylinder wall to ensure an air (vacuum) tight connection. In the rest position (position when the tip lock is in contact to the front surface of the cylinder respectively the seal and thus closes the air inlet opening) the tip lock will be closed by a hold spring (16a) as shown in Fig. 14A or 15b.
  • the vacuum tank comprises a third opening, the third opening being covered by a cover, and the cover being configured to deform under the vacuum created in the vacuum tank.
  • the cover is typically made of a flexible material, such as a plastic film, and it is configured to have a concave form when a vacuum is created in the vacuum tank, i.e. to bend towards the inner part of the vacuum tank. This allows the user to easily see that an under-pressure has indeed been created in the vacuum tank.
  • the characteristics of the spring are selected such that it is suitable for the present purpose.
  • the spring may be configured to provide an under-pressure of 0.2-0.5 bar in the vacuum tank, when compared to atmospheric pressure, respectively a vacuum of 0.5 to 0.8 bar in the vacuum tank.
  • the spring is made of stainless spring steel.
  • the thickness of the ware used for the manufacture of the spring can be for example 0.5-2.0 mm, typically around 1 mm.
  • the uncompressed length of the spring is about 100 mm, and the compressed length of the spring is about 20 m m .
  • the present tenaculum can be made of various materials. It may be made for example from metal, which is easy to sterilise and thus the tenaculum can be re-usable. It may also be made of plastic materials (for example polyethylene or polypropylene), which are typically more light-weight and less expensive to manufacture.
  • the different parts can also be made of different materials, for example the handle part and the parts therein in metal and the suction tube and suction head in plastic.
  • at least two of the suction head, the suction tube and the handle part can be made detachably connected to each other. This means that the suction head can be detachable from the rest of the tenaculum, or the suction tube can be datable from the handle, from the suction head or both. This way, for example the handle part can be made re-usable, while the suction tube and/or the suction head can be made disposable, i.e. changed after each use.
  • the size of the vacuum tank is also selected such that it is sufficient for the present purpose. For example, its size can be 5-25 ml. It has been estimated that the force needed for pulling the cervix is 7-10 N.
  • the spring is first compressed and locked or kept compressed manually. The tenaculum is then positioned such that the suction head is arranged on the fornix. When the suction head is properly in place, the spring is released (manually or by using the spring release means), thus creating an under-pressure in the vacuum tank, thereby straightening the uterus by pulling it. This means that the user, when applying the suction tenaculum, only has to release the button and the compressed (pre-loaded) spring will generate the vacuum.
  • the user does not need to use any force when applying the tenaculum and can therefore concentrate on placing the suction tip in the correct position. Further, the handle does not need to be locked in order to maintain the vacuum during use.
  • a correct spring size also ensures that not too much force is applied to the tissue, thus minimizing the possible tissue trauma.
  • the pressure is released from the vacuum tank and the tenaculum removed.
  • the suction head needs to extend to an area that is high enough, such that a sufficient suction force can be applied without causing extensive trauma to the tissue.
  • the suction head can have any suitable shape and the present tenaculum does work with any type of suction head .
  • the suction head is thus according to known art in the present tenaculum, i.e. a cup-shaped part.
  • the suction head is typically made of a plastic material that is somewhat flexible, such as from soft polyethylene, silicone, thermoplastic polyurethane (TPU) or thermoplastic polyethylene (TPE).
  • the vacuum-based tenaculum may also have another structure than what has been discussed above.
  • the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the vacuum pump comprises
  • a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
  • a piston head moveably arranged within the vacuum tank; - an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to a means for moving the piston ; and
  • a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tan k from the second opening .
  • the means for moving the piston is movably arranged in an opening arranged in the handle part, said opening having a first end and a second end .
  • the means for moving the piston comprises a knob attached to the axle of the piston .
  • the dimensions of the opening are such that when the piston head is against the first opening of the vacuum tank, at its first end, the knob abuts against the first end of the opening .
  • the knob also comprises means for locking it into position, for example means similar to what has been explained above.
  • the user pulls the knob on the handle part, thereby reducing the pressure in the vacuum tan k.
  • the reduced pressure will create a suction force to the suction head of the tenaculum and the suction head will attach onto the tissue (e.g . the vaginal fornix) .
  • the knob is preferably equipped with means to lock it when pulled back and therefore the vacuum will be maintained for the required time.
  • the means for locking the knob into its position at the second end of the opening can thus be such that they are automatical ly activated when the knob abuts against the second end of the opening .
  • the means for locking is released and the vacuum tank re-pressured to atmospheric pressure, thereby also releasing the fixed suction head.
  • This re-pressurization may be achieved by simply allowing the piston to move towards the first end of the vacuum tank, or the vacuum tank can be equipped with a movable collar that closes an opening to outside air. When the collar is moved, the opening is exposed and air can enter the vacuum tank.
  • the vacuum-based tenaculum may also have yet another structure than what has been discussed above.
  • the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the vacuum pump comprises
  • a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
  • an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to a means for moving the piston ; and - a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening .
  • the means for moving the piston is movably arranged in an opening arranged in the handle part, said opening having a first end and a second end .
  • the means for moving the piston comprises a knob that is connected to the axle of the piston via a gearing.
  • the gearing may for example be of a cogwheel-type, for example a combination of a wheel and bar with a series of cooperating projections on their edges, which transfer motion by engaging with the respective projections.
  • the dimensions of the opening are such that when the piston head is against the first opening of the vacuum tank, the knob abuts against the second end of the opening.
  • the knob also comprises means for locking it into position, for example means similar to what has been explained above.
  • This embodiment is thus similar to the preceding one, with the exception that gearing is included to the device.
  • gearing is included to the device.
  • the user pushes (moves away from the user) the knob instead of pulling (moving towards the user), which may give the possibility to reach a higher level of under-pressure in an easier manner than in the preceding embodiment, depending on the required under-pressure.
  • a release mechanism and a renewed vacuum generation are likewise possible as with the other embodiments.
  • the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the vacuum pump comprises
  • a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
  • axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for moving the piston;
  • a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening.
  • the means for moving the piston comprise at least one part articulately connected to the axle of the piston, articulately meaning that the parts can rotate with respect to each other. Indeed, there is an axle part articulately connected by its first end to the second end of the axle of the piston. This axle part is connected by its second end to a gripping part.
  • the axle part and the gripping part may be integral or they may be made of separate parts that are attached to each other. Typically, the axle part is arranged within the handle part and the gripping part is arranged at least mostly outside the handle part.
  • the gripping part is arranged at such an angle with respect to the vacuum tank and the handle part, that the user can with one hand squeeze the handle part and the gripping part together, thereby moving the axle of the piston such that the piston head is moved from a first end of the vacuum tank to its second end.
  • the axle part and the gripping part are arranged essentially in a 90° angle with respect one another. The under-pressure is thus created with a pumping movement. In this way the user may easily decide the level of vacuum.
  • the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
  • the vacuum pump comprises
  • a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
  • axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for moving the piston;
  • a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening.
  • the means for moving the piston is somewhat different in this embodiment. Indeed, it comprises a gear rack (bar-type cogwheel) arranged within the handle part, and to extend towards a second (proximal) end of the handle part.
  • this gear rack is either arranged in connection with the axle of the piston or the axle of the piston functions as the gear rack, i.e. they are integral.
  • It also comprises a gear (wheel-type cogwheel) arranged in connection with the gear rack, and also arranged within the handle part.
  • a gripping part is connected to the gear and it protrudes from the handle part.
  • the under-pressure is generated by pumping several times. Every squeeze of the gripping part rotates the gear which moves on the gear rack, whereby the piston head moves towards the second end of the vacuum tank, thus creating a reduced pressure inside the vacuum tank.
  • a ratchet inside the gear allows rotary motion only in one direction.
  • the gripping part returns to its original position the reduced pressure thus remains inside the tank.
  • the gripping part returns to its starting position by a spring force.
  • the force needed for creating a suitable under-pressure is decreased compared to the preceding embodiment.
  • the tenaculum also preferably comprises means for releasing the under-pressure from the vacuum tank, for example by releasing the gear from the gear rack, thereby allowing the piston head to move back towards the first end of the vacuum tank, and to thus release the suction head.
  • This embodiment also allows an easy control of the amount of under- pressure in the vacuum tank.
  • Figures 1A to ID illustrate a tenaculum according to an embodiment.
  • the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3.
  • a vacuum pump is inside the handle part and thus not visible in this Figure.
  • the means for compressing the spring 4 is partly visible at a second end 3b of the handle part 3, the second end 3b being opposite a first end 3a, to which the suction tube 2 is connected.
  • FIG. 1 illustrates a cross-sectional view of the tenaculum of Figure 1. It shows a vacuum tank 12, a piston head 13 therein and a seal 14 arranged around the piston head 13. The piston head is attached to an axle 15, which is in turn attached to the means for compressing the spring 4 and arranged inside a spring 16.
  • the Figure further shows the button 6 and a small spring 17 underneath the button 6.
  • the Figure shows a spring chamber 8, wherein the spring (16) is arranged.
  • Figure 3 illustrates an exploded view of the tenaculum of Figure 1.
  • the Figure shows the various parts of the tenaculum, i.e. the suction head 1, the suction tube 2, the handle part 3, the means for compressing the spring 4, the button 6, the cover 9, the air inlet opening 11, the vacuum tank 12, the piston head 13, the seal 14, the axle 15, the spring 16 and the small spring 17.
  • the Figure further shows a gripping ridge 18 designed to facilitate the moving of the cover 9 by the user.
  • notches 19 are shown in the axle 15, for locking and releasing the spring in cooperation with the button 6.
  • Figures 4A-4D illustrate a tenaculum according to another embodiment.
  • the tenaculum has a similar suction head 1, suction tube 2 and handle part 3 as in the preceding embodiment.
  • the means for compressing the spring 20 is moved in the direction of the arrow 24 for compressing the spring (inside the handle part 3) and locked in place automatically.
  • a third opening is arranged in the handle part 3, covered by a third cover 23, made of an elastic material.
  • the handle part 3 comprises also a cover 22 and a button 21 as part of means for releasing the spring.
  • the user thus compresses the spring by pushing the means for compressing the spring 20 in the direction of the arrow 24.
  • the user pushes the button 21 in the direction of the arrow 25 ( Figure 4B).
  • the means for compressing the spring 20 is moved in the direction of the arrow 26, i.e. in an opposite direction to that of the compression.
  • the third cover 23, also called a pressure indication dome, is then buckled inwardly, showing that an under- pressure is created within the vacuum tank.
  • the cover 22 is moved in the direction of the arrow 27 (or in the opposite direction), thus exposing an opening 28 allowing air to enter the vacuum tank.
  • Figure 5 illustrates a cross-sectional view of the tenaculum of Figure 4.
  • a spring 28 is arranged within the vacuum tank 29, as is a volume reducer 30.
  • a piston head 31 is equipped with a seal 32 and attached to an axle 33.
  • a small spring 34 is arranged below the button 21.
  • the Figure further illustrates the third cover 23, a cover 22 and an opening 48, allowing air to enter the vacuum tank 29 when the cover 22 is moved.
  • the axle 33 further comprises notches 35 designed to cooperate with the button 21.
  • FIGs 6A-6B illustrate a tenaculum according to yet another embodiment.
  • the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3.
  • the handle part comprises an opening 45 having a first end 45a and a second end 45b.
  • a knob 40 is arranged to move in the direction of the arrow 46, as well as in the opposite direction, as is shown in more detail in Figure 7.
  • Figure 7 is a cross-sectional view of the tenaculum of Figure 6 (i.e. Figures 6A and 6B) and shows a vacuum tank 41 with a piston head 42 arranged therein.
  • the piston head 42 comprises a seal 43 and is attached to an axle 44.
  • the axle 44 is attached to the knob 40 (means for moving the piston) such that when the knob 40 is moved, the piston head 42 is also moved.
  • the knob Prior to use of the tenaculum, the knob is moved to the first end 45a and preferably abuts against this end of the opening 45. At this moment, the piston head 42 is at a first end 41a of the vacuum tank 41.
  • the user then pulls the knob 40 in the direction of the arrow 46, whereby the piston head 42 moves also in the same direction, shown with the arrow 47. This movement is carried out until the knob 40 abuts the second end 45b of the opening 45. Thereafter, it is either mechanically locked there or kept there manually during the operation, i.e. until the tenaculum is no longer needed.
  • FIGS 8A-8B illustrate a tenaculum according to a further embodiment.
  • This embodiment is similar to that of Figures 6 and 7, and the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3.
  • the handle part comprises an opening 51 having a first end 51a and a second end 51b.
  • a knob 50 (means for moving the piston) is arranged to move in the direction of the arrow
  • Figure 9 is a cross-sectional view of the tenaculum of Figure 8.
  • FIG. 8A and 8B shows a vacuum tank 53 with a piston head 54 arranged therein.
  • the piston head 54 comprises a seal 55 and is attached to an axle (not visible in the Figure).
  • the axle comprises a gear rack, designed to cooperate with a wheel 56 arranged in the knob 50.
  • the knob 50 Prior to use of the tenaculum, the knob 50 is moved to the second end 51b and preferably abuts against this end of the opening 54. At this moment, the piston head 54 is at a first end 53a of the vacuum tank
  • FIG. 10 illustrates a cross-sectional view of a still further tenaculum according to an embodiment. Also this tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. A vacuum pump arranged inside the handle part 3 comprises a vacuum tank 60.
  • a piston head 61 with its seal 62 is moveably arranged within the vacuum tank 60 and attached to an axle 63.
  • the means for moving the piston comprises an axle part 64 articulately connected by its first end 64a to the second end of the axle 63 of the piston.
  • This axle part 64 is connected by its second end to a gripping part 65.
  • the gripping part 65 is arranged at such an angle with respect to the vacuum tank 60 and the handle part 3, that the user can with one hand squeeze the handle part 3 and the gripping part 65 together, thereby moving the axle 63 of the piston in the direction of the arrow 66 such that the piston head 61 is moved from a first end of the vacuum tank 60 to its second end.
  • Figures 11A-11C illustrate cross-sectional views of another tenaculum according to an embodiment.
  • the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3.
  • a vacuum pump arranged inside the handle part 3 comprises a vacuum tank 70.
  • a piston head 71 with its seal 72 is moveably arranged within the vacuum tank 70 and attached to an axle 73.
  • the axle 73 is in the form of a gear rack designed to cooperate with a means for moving the piston.
  • the means for moving the piston comprises a gear 74 (wheel-type cogwheel) arranged in connection with the gear rack 73 (i.e. the axle of the piston), and also arranged within the handle part 3.
  • a gripping part 75 is connected to the gear 74 and protrudes from the handle part 3.
  • the under-pressure is generated by pumping several times, i.e. moving the gripping part 75 in the direction of the arrow 78. Every squeeze of the gripping part 75 rotates the gear 74 which moves on the gear rack 73, whereby the piston head 71 moves along the arrow 76, 79, thus creating a reduced pressure inside the vacuum tank 70.
  • a ratchet 77 inside the gear allows rotary motion only in one direction.
  • FIGS 12A to 12D illustrate a tenaculum according to a further embodiment of the invention.
  • the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3.
  • a vacuum pump is inside the handle part and thus not visible in this Figure.
  • the means for compressing the spring 4 is partly visible at a second end 3b of the handle part 3, the second end 3b being opposite a first end 3a, to which the suction tube 2 is connected.
  • FIG 12B the means for compressing the spring 4 is shown in the position where the spring is compressed, i.e. the means is mostly inside the handle part 3.
  • a button 6 is in an upper position, compared to its position in Figure 12A. This upper position shows that the spring is locked to the compressed position.
  • the slider can have gripping ridges 18.
  • the air inlet opening 11 is encircled by a seal 14a in ring or tape.
  • Figure 13A to 13C illustrate a cross-sectional view of the tenaculum of Figure 12A to 12D. It shows a vacuum tank 12, a piston head 13 therein and a seal 14a arranged around the piston head 13, whereby the seal is optional if an air-tight connection between piston head and the wall of the vacuum tank is guaranteed.
  • the piston head is attached to an axle 15 with a notch 19, which is in turn attached to the means for compressing the spring 4 and arranged inside a spring 16.
  • the Figure further shows the button 6 and a small spring 17 underneath the button 6.
  • the Figure shows a spring chamber 8, wherein the spring is arranged and the slider 91 for releasing the vacuum from the vacuum tank and thus the tenaculum.
  • Figure 14 illustrates an exploded view of the tenaculum of Figure 13 (A to C).
  • the Figure shows the various parts of the tenaculum, i.e. the suction head 1, the suction tube 2, the handle part 3, the means for compressing the spring 4, the button 6, the cover in form of a slider 91, the air inlet opening 11, the vacuum tank 12, the piston head 13, the seal 14, the axle 15, the spring 16 and the small spring 17.
  • the Figure further shows a gripping ridge 18 designed to facilitate the moving of the cover/slider 91 by the user. In this embodiment only one notch 19 is present at the distal end of the axle 15, for locking and releasing the spring in cooperation with the button 6.
  • the Figure furthermore shows the seal 14a on the piston head 13 to ensure an air tight connection between the piston head and the wall of the vacuum tank and a further seal 14a which is needed to seal the air inlet opening 11.
  • a second spring 16a is pressing the cover/slider 91 on the air inlet opening 11 in the home position.
  • the vacuum tube tip can be manufactured as an individual component, as shown in Fig. 14 and marked with reference sign 81 or it can be an overall part of the vacuum tank (12, 41, 53, 70. For production-orientated reasons it is preferred to manufacture the vacuum tube tip as an individual part.
  • Figures 15A is a detailed view of the second end of the handle. It shows in detail the suction tube 2 the cover/slider 91, the tip lock 80 which seals the air inlet opening 11 on the front surface and the vacuum tube tip 81.
  • FIG. 15B shows a cross-sectional view of Figure 15A.
  • 14a marks the seal which guarantees an air tight closing of the air inlet opening 11 and a second spring 16a which compresses the cover/slider 91 to the air inlet opening 11 in the home position (Fig 15B).
  • Figure 15C illustrates the air inlet opening 11 in the open position by moving the cover/slider 91 to the proximal end of the tenaculum.
  • a seal ring or seal tape 14a is added between the vacuum tube tip and the cover/slider which moves the pressure release mechanism.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • External Artificial Organs (AREA)
  • Compressors, Vaccum Pumps And Other Relevant Systems (AREA)
  • Hooks, Suction Cups, And Attachment By Adhesive Means (AREA)
  • Manipulator (AREA)
  • Jet Pumps And Other Pumps (AREA)

Abstract

The present invention relates to a tenaculum comprising a suction head (1) and a handle part (3) connected to each other by a suction tube (2), the handle part comprising a vacuum pump. The vacuum pump comprises a vacuum tank (12) comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening; a spring (16); means for compressing the spring (4); and a piston. The piston comprises a piston head (13) moveably arranged within the vacuum tank; an axle (15) having a first end and a second end, its first end being connected to the piston head (13) and its second end being connected to the means for compressing the spring (4); and a pressure seal (14) arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening. The spring (16) is arranged to move the piston head (13).

Description

A VACUUM-BASED TENACULUM
FIELD OF THE INVENTION
The present invention relates to a vacuum-based tenaculum, comprising a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump.
BACKGROUND AND OBJECTS OF THE INVENTION
A tenaculum is a medical instrument, usually classified as a type of forceps. It consists of a slender sharp-pointed hook attached to a scissor-like handle and is used mainly in surgery for seizing and holding parts. One purpose of the tenaculum is to grab at the vaginal fornix before insertion of an intrauterine system (IUS), or for other gynaecological procedures, and to pull back gently to straighten the uterus. Indeed, the uterus is typically in flexion towards cervix and it must be straightened to be able to enter the uterine cavity with instruments, or for insertion of the IUS.
Some tenaculum based on vacuum for gynaecological use are known in the prior art. Typically, the vacuum is either provided from an outside source (a separate vacuum pump, for example), or the handle of the device comprises a hand-held vacuum pump. However, no precise description of such hand-held vacuum pumps seems to be available, a syringe mechanism being the only concrete example given in the prior art. For example, document WO 2016/0923458 presents a tenaculum comprising a suction module and a vacuum system. The vacuum system comprises a vacuum reserve source and a support of the vacuum reserve source, that cooperate to form a pump that can be manually activated by a reciprocal sliding motion of the vacuum reserve source within the support. Document WO 2016/018938 discloses a similar tenaculum, also comprising a vacuum source in the handle. The document mentions, as a practical embodiment, a syringe mechanism for creating the vacuum. Likewise, document US 2012/0283595 discloses a tenaculum comprising a hand-held vacuum pump, without however giving any further indication on how said pump is construed. It is thus not possible to evaluate the practicality of these vacuum pumps, as the prior art does not seem to give any indication how such hand- held vacuum pumps are to be operated. For example, it is not apparent how the devices could be used with only one hand.
WO2013/082452 discloses an apparatus for inserting a device into the uterus. The apparatus contains also a suction assembly which can be used as a tenaculum that provides temporary attachment to the cervix through vacuum/suction mechanism. In some embodiments of this invention also a spring is used in connections with the vacuum creating mechanism. However, in this device the spring is used to release and not to generate the vacuum. Creation of the vacuum in this reference occurs by moving a handle. This movement can shift the vacuum tip (suction head), which could lead to a leakage between the suction head and the cervix tissue. WO2017/089982 discloses a hemorrhoid treatment device. Here a vacuum is used to aspirate the hemorrhoid tissue for deploying the ligature on the neck of the hemorrhoid tissue.
WO2014/205351 discloses an apparatus with dilation members. The dilation members should facilitate the insertion of an intrauterine system into the uterus. However, also this document does not give any indication on how the vacuum is generated and the vacuum pump is construed.
It is therefore an aim of the present invention to provide a suction- based tenaculum that at least partially solves the problems of the prior art devices. In particular, one object of the invention is to provide a tenaculum that is cost-effective to manufacture as well as easy, reliable and light to use, even with one hand . It is a further object of the invention to provide a tenaculum that is reliable in that the amount of vacuum obtained is constant at each application . It is furthermore an object to provide a tenaculum that can be either for single use or for multiple uses. Naturally, the tenaculum needs to be sterilisable. It is especially an object of the invention to provide a tenaculum, even if for single use (i.e. for a single insertion of an IUS, for a single patient), wherein the vacuum pump can be easily reloaded if the first attempt of using it is not satisfactory.
SUMMARY OF THE INVENTION
The present description relates to a tenaculum comprising a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The vacuum pump comprises - a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
- a spring;
- means for compressing the spring ; and
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring; and - a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening .
In the tenaculum, the spring is arranged to move the piston head .
BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A-1D illustrate a tenaculum according to an embodiment.
Fig. 2 illustrates a cross-sectional view of the tenaculum of Fig. 1.
Fig. 3 illustrates an exploded view of the tenaculum of Fig. 1.
Fig. 4A-4D illustrate a tenaculum according to an embodiment.
Fig. 5 illustrates a cross-sectional view of the tenaculum of Fig. 4.
Fig. 6A-6B illustrate a tenaculum according to an embodiment.
Fig. 7 illustrates a cross-sectional view of the tenaculum of Fig. 6.
Fig. 8A-8B illustrate a tenaculum according to an embodiment.
Fig. 9 illustrates a cross-sectional view of the tenaculum of Fig. 8.
Fig. 10 illustrates a cross-sectional view of a tenaculum according to an embodiment.
Fig. 11A-11C illustrate cross-sectional views of a tenaculum according to an embodiment.
Fig. 12A-12D illustrate a tenaculum according to a further embodiment, Fig. 13A-13C illustrate a cross-sectional view of the tenaculum of Fig. 12A-12D.
Fig. 14A-1 illustrates an exploded view of the tenaculum of Fig. 13.
Fig. 14B shows details of Fig. 14A namely the piston head 13 with the seal 14 and the screw anchor 82 which ensures a firm connection between the piston head 13 and the axle 15.
Fig. 15A illustrates the pressure (vacuum) release mechanism with the cover which exposes the air inlet opening in detail.
Fig. 15B-15C illustrate a cross sectional view of Figure 15A. DETAILED DESCRIPTION OF THE INVENTION
A typical tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The suction head, as discussed below, can be any suitable suction head, for example as known from a prior art document mentioned above. This suction head is connected to a suction tube. The suction tube is also as is known in the prior art, typically a relatively thin, hollow tube. It can be made of plastic or metal, wherein plastic is preferred. The inner diameter of the suction tube can be for example 2- 5 mm, its outer diameter for example 3-6 mm.
The handle part is designed such that it can be easily handled, i.e. it has a size and shape that is suitable typically for handling with one hand. The handle comprises a vacuum pump, which is typically at least partially arranged inside the handle. It will be explained below in more detail in which cases the vacuum pump is inside the handle and in which cases it may be partially outside the handle. The vacuum pump comprises a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening. The suction tube may thus extend partially inside the handle part in case the vacuum tank is not directly arranged at a first end of the handle part. The suction tube is naturally connected to both the suction head and the first opening of the vacuum tank in an airtight manner, known as such for a person skilled in the art. For production-orientated reasons the vacuum tube tip can be manufactured as an individual component or it can be an overall part of the vacuum tank.
In this description, by first ends are meant the distal ends of the device, i.e. the ends that are further away from the user when the tenaculum is used. The second ends are the proximal ends, i.e. the ends that are closer to the user when the tenaculum is used. Moreover, the terms vacuum and under-pressure are used interchangeably. Indeed, the pressure within the vacuum pump is naturally not a full vacuum, i.e. the vacuum tank is not completely devoid of air. Instead, a pressure below atmospheric pressure, i.e. an under-pressure is created within the pressure tank. The under-pressure can be for example of the order of 0.2-0.5 bar in the vacuum tank, when compared to atmospheric pressure, i.e. the pressure within the vacuum tank is for example 0.2- 0.5 bars below the atmospheric pressure or in other words the pressure in the vacuum tank is 0.5 to 0.8 bar. The term vacuum is thus used in the same sense as in the prior art.
The vacuum pump further comprises a spring and means for compressing the spring. The spring is made of a suitable material, most typically of metal. It has a spring constant that is suitable for the present purpose, for example 0.7 N/mm. The spring is arranged to move the piston head. The means for compressing the spring is arranged in a manner that it can compress the spring, typically such that the spring is compressed towards the first end of the handle. The means for compressing the spring is discussed in more detail below. The present tenaculum has the advantage, that it can easily and safely be used with only one hand. Indeed, should the vacuum pump be based on a simple piston-and-syringe-structure, pulling the piston carries the risk the syringe will also move, which could lead to leaking on the suction head, as even a small movement of the vacuum chamber could be transferred via the suction tube to the suction head. In particular in the initial phase (when there is no vacuum in the device), such movement would lead immediately to a leak between suction head and fornix. This would compromise the use of the tenaculum. However, in the present tenaculum, movements of the vacuum source are practically impossible, since the force to pull the piston is created by the spring (and not by any pulling the piston).
The vacuum pump further comprises a piston. The piston comprises a piston head moveably arranged within the vacuum tank; an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring; and a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening. The piston head is arranged to move within the vacuum tank, from its first end towards its second end and vice versa. The piston head is also equipped with a pressure seal, which allows an airtight separation of the vacuum tank into two parts, by the piston head. Indeed, the piston head, when moved from the first end of the vacuum tank towards the second end of the vacuum tank creates an under-pressure within the vacuum tank, when the tenaculum is in place and the suction head is arranged in contact with the vaginal fornix and no air can thus enter the vacuum tank via the suction head and the suction tube.
The piston also comprises an axle, the first end of which is connected to the piston head and the second end of which is connected to the means for compressing the spring. The means for compressing the spring can thus be for example a solid cylinder or a button. The means for compressing the spring can either be such that when the spring is in its uncompressed state, the means for compressing the spring is mostly outside the handle and it is pushed at least mainly to the inside of the handle when the spring is compressed.
The present tenaculum is thus a mechanical single- or multiple-use small-sized device, where the forceps-type tenaculum is replaced by a suction tenaculum that works using a vacuum (i.e. an under-pressure). The vacuum is generated mechanically without any external vacuum source. The tenaculum can be designed to fit to most cervix anatomies and to be compatible with the environmental conditions at the cervix tip or vaginal fornix (dry, wet, tissue surface and elasticity, chemicals and medications typically used during gynecological procedures). The vacuum can be re-applied if lost and it is possible to release it at any time of the procedure. Furthermore, the pressure reduction in the tenaculum can be adjusted to a desired level in some embodiments, as discussed below. According to an embodiment, the tenaculum comprises a spring chamber, wherein the spring is arranged within the spring chamber and the axle of the piston is arranged to extend to the spring chamber via the second opening of the vacuum tank. The spring chamber is typically arranged along the same axis as the vacuum tank and next to it. In this embodiment, the means for compressing the spring may be arranged to enter the spring chamber at least partially when the spring is compressed.
According to another embodiment, the spring is arranged within the vacuum tank. In this embodiment, the spring is arranged around the axle of the piston, i.e. the axle is typically in the centre of the spring, when the spring is in its compressed state. Also, in this embodiment, when the spring is compressed, it does not entirely fill up the space inside the vacuum tank. In an embodiment, a volume reducer is also arranged within the vacuum tank. This volume reducer is connected to the piston head, on an opposing side of it with respect to the axle of the piston, and typically has a cylindrical shape and fitted inside the spring. The spring may be a compression spring or a conical compression spring. In case a conical compression spring is used, a volume reducer is typically not required. The tenaculum, especially its handle part, naturally may comprise any other structures that are required, such as reinforcing structures and even empty space if needed in order to achieve a suitable shaped handle part. Additionally, the means for compressing the spring may be such that they are directly pushed in the longitudinal direction of the tenaculum, thus pushing the spring manually. Alternatively, the means for compressing the spring may comprise suitable parts, such as cogwheels, allowing the spring to be compressed with less force. The handle part may have a length that is 10-25 cm, for example about 20 cm, and its diameter may be approximately 2 cm. It may also comprise a partial sleeve in which the means for compressing the spring is arranged to move. This means that from one side, the means for compressing the spring is exposed and from the other side, it is protected by the partial sleeve. This protects also the user's hand when the spring is released (and the means for compressing the spring is typically pushed back to its original position). Similarly, the user's hand does not hinder the movement of the means for compressing the spring. The spring, when in compressed position, can be maintained in this compressed position manually, i.e. by keeping pushing the means for compressing the spring or in another manner manually keeping the position. Alternatively, the tenaculum may comprise means for releasably locking the spring in its compressed position and means for releasing the spring for its compressed position. This means may be the same, i.e. the means for releasing the spring can be integrated with the means for locking the spring (or vice versa) or they may be separate means.
According to a preferred embodiment, the axle of the piston is provided with notches configured to cooperate with the means for releasably locking the spring and/or with the means for releasing the spring. The notches may be arranged regularly along the length of the axle or they may be arranged only intermittently or there may be only one or two such notches. For example, the means for locking the spring and/or the means for releasing the spring may be composed of a small locking/releasing spring and a button. The button may have a cylindrical or a cubic form and it may comprise an opening throughout it, so that it can be arranged to surround the axle of the piston. The locking/releasing spring can be arranged underneath the button, and the button would then extend to the outside of the handle part. When the user presses the button, the spring underneath the button allows the button to move downwards, thus releasing the notch of the axle from the opening in the button, and the spring is free to move. The arrangement can be such that when the spring is compressed, the means for locking the spring in its compressed position can be automatically activated, and when the user is ready (i.e. the tenaculum is properly positioned and the suction head is in its place), the spring is released by pressing the button.
According to an embodiment, the means for releasing the spring is arranged to be set at least two different positions to create at least two different levels of under-pressure to the suction tube and the suction head. This may be arranged such that notches are arranged in the axle, and these notches (or similar) allow setting the spring at different positions when preparing to use the tenaculum. Indeed, the user may action the means for compressing the spring (typically by pushing it) to an intermediate position between the position where the spring is uncompressed and the position where the spring is fully compressed. There may be one, two, three, four, five or even more such intermediate positions, typically thus one, two, three, four, five or more notches in the axle. The user has to decide before positioning the tenaculum which vacuum would be required (less or more of under- pressure). If it is decided to start with a light vacuum (a small under- pressure), it is possible to press in the means for compressing the spring only up to a first or second notch. If it turns out that the vacuum is not strong enough to hold the cervix, the user may have a second try and press in the means further, to a third or fourth notch, or until the spring is completely compressed. In a preferred embodiment of the inventions there is only one notch in the axle, which holds the spring in the fully compressed position.
In another embodiment, the handle part may be equipped with several button locks (as described above), so that the level of under-pressure used during the procedure can be adjusted to a desired level. This adjustment can be done before the operation is started, i.e. during the compression of the spring, or it may be done during the operation.
The vacuum tank may comprise an air inlet opening, covered by a moveable cover. This air inlet opening is in gas communication with outside of the tenaculum (i.e. with atmospheric surroundings), and it is covered by a moveable cover. The air inlet opening of the vacuum tank is naturally in gas connection with a respective opening in the handle part. The cover is, when covering the air inlet opening, airtight, i.e. no air can enter the vacuum tank via this air inlet. Only after the operation is finished and the tenaculum is to be removed, the cover is moved to expose the air inlet opening, to allow air to enter the vacuum tank and thus to release the suction head from the tip of the fornix. The cover may for example be in the form of a ring moveably arranged on the handle part. The ring may be moved forward (towards the first end of the handle part) or backwards (towards the second end of the handle part) to expose the air inlet openings of the handle part and the vacuum tank to outside air. The air inlet opening might be on the cylinder wall of the vacuum tank or alternatively on the front surface (in this application also referred to as vacuum tube tip) of the cylinder wall (for details see Fig. 15B and 15C). When the air inlet opening is on the front surface the cover can be in the form of a slider, which operates the tip lock which seals the air inlet opening on the front surface. It is advantageous if a seal (ring or tape) is attached to the front surface of the cylinder wall to ensure an air (vacuum) tight connection. In the rest position (position when the tip lock is in contact to the front surface of the cylinder respectively the seal and thus closes the air inlet opening) the tip lock will be closed by a hold spring (16a) as shown in Fig. 14A or 15b.
According to yet an embodiment, the vacuum tank comprises a third opening, the third opening being covered by a cover, and the cover being configured to deform under the vacuum created in the vacuum tank. In this embodiment, the cover is typically made of a flexible material, such as a plastic film, and it is configured to have a concave form when a vacuum is created in the vacuum tank, i.e. to bend towards the inner part of the vacuum tank. This allows the user to easily see that an under-pressure has indeed been created in the vacuum tank.
The characteristics of the spring are selected such that it is suitable for the present purpose. For example, the spring may be configured to provide an under-pressure of 0.2-0.5 bar in the vacuum tank, when compared to atmospheric pressure, respectively a vacuum of 0.5 to 0.8 bar in the vacuum tank. As another example, the spring is made of stainless spring steel. The thickness of the ware used for the manufacture of the spring can be for example 0.5-2.0 mm, typically around 1 mm. In one example, the uncompressed length of the spring is about 100 mm, and the compressed length of the spring is about 20 m m .
The present tenaculum can be made of various materials. It may be made for example from metal, which is easy to sterilise and thus the tenaculum can be re-usable. It may also be made of plastic materials (for example polyethylene or polypropylene), which are typically more light-weight and less expensive to manufacture. The different parts can also be made of different materials, for example the handle part and the parts therein in metal and the suction tube and suction head in plastic. Moreover, at least two of the suction head, the suction tube and the handle part can be made detachably connected to each other. This means that the suction head can be detachable from the rest of the tenaculum, or the suction tube can be datable from the handle, from the suction head or both. This way, for example the handle part can be made re-usable, while the suction tube and/or the suction head can be made disposable, i.e. changed after each use.
The size of the vacuum tank is also selected such that it is sufficient for the present purpose. For example, its size can be 5-25 ml. It has been estimated that the force needed for pulling the cervix is 7-10 N. During use, the spring is first compressed and locked or kept compressed manually. The tenaculum is then positioned such that the suction head is arranged on the fornix. When the suction head is properly in place, the spring is released (manually or by using the spring release means), thus creating an under-pressure in the vacuum tank, thereby straightening the uterus by pulling it. This means that the user, when applying the suction tenaculum, only has to release the button and the compressed (pre-loaded) spring will generate the vacuum. In this way the user does not need to use any force when applying the tenaculum and can therefore concentrate on placing the suction tip in the correct position. Further, the handle does not need to be locked in order to maintain the vacuum during use. A correct spring size also ensures that not too much force is applied to the tissue, thus minimizing the possible tissue trauma.
Once the tenaculum is no longer needed (for example an intrauterine system has been properly placed within the uterus), the pressure is released from the vacuum tank and the tenaculum removed.
The suction head needs to extend to an area that is high enough, such that a sufficient suction force can be applied without causing extensive trauma to the tissue. The suction head can have any suitable shape and the present tenaculum does work with any type of suction head . The suction head is thus according to known art in the present tenaculum, i.e. a cup-shaped part. The suction head is typically made of a plastic material that is somewhat flexible, such as from soft polyethylene, silicone, thermoplastic polyurethane (TPU) or thermoplastic polyethylene (TPE).
The vacuum-based tenaculum may also have another structure than what has been discussed above. Indeed, according to an embodiment, the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
- a piston comprising
- a piston head moveably arranged within the vacuum tank; - an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to a means for moving the piston ; and
- a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tan k from the second opening .
The means for moving the piston is movably arranged in an opening arranged in the handle part, said opening having a first end and a second end . The means for moving the piston comprises a knob attached to the axle of the piston . Preferably, the dimensions of the opening are such that when the piston head is against the first opening of the vacuum tank, at its first end, the knob abuts against the first end of the opening . Likewise, when the piston head has been moved to the second opening of the vacuum tank, at its second end (i.e. an under- pressure has been created within the vacuum tan k), the knob abuts against the second end of the opening . Preferably, the knob also comprises means for locking it into position, for example means similar to what has been explained above.
In this embodiment, once the tenaculum has been properly positioned, the user pulls the knob on the handle part, thereby reducing the pressure in the vacuum tan k. The reduced pressure will create a suction force to the suction head of the tenaculum and the suction head will attach onto the tissue (e.g . the vaginal fornix) . The knob is preferably equipped with means to lock it when pulled back and therefore the vacuum will be maintained for the required time. The means for locking the knob into its position at the second end of the opening can thus be such that they are automatical ly activated when the knob abuts against the second end of the opening . After the procedure is finished and the tenaculum is no longer needed (but needs to be removed), the means for locking is released and the vacuum tank re-pressured to atmospheric pressure, thereby also releasing the fixed suction head. This re-pressurization may be achieved by simply allowing the piston to move towards the first end of the vacuum tank, or the vacuum tank can be equipped with a movable collar that closes an opening to outside air. When the collar is moved, the opening is exposed and air can enter the vacuum tank. The details and embodiments explained above in connection to the tenaculum as described in the present claims apply mutatis mutandis to the present tenaculum, where ever applicable.
The vacuum-based tenaculum may also have yet another structure than what has been discussed above. Indeed, according to an embodiment, the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening ;
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to a means for moving the piston ; and - a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening .
The means for moving the piston is movably arranged in an opening arranged in the handle part, said opening having a first end and a second end . The means for moving the piston comprises a knob that is connected to the axle of the piston via a gearing. The gearing may for example be of a cogwheel-type, for example a combination of a wheel and bar with a series of cooperating projections on their edges, which transfer motion by engaging with the respective projections. Preferably, the dimensions of the opening are such that when the piston head is against the first opening of the vacuum tank, the knob abuts against the second end of the opening. Likewise, when the piston head has been moved to the second opening of the vacuum tank (i.e. an under-pressure has been created within the vacuum tank), the knob abuts against the first end of the opening. Preferably, the knob also comprises means for locking it into position, for example means similar to what has been explained above.
This embodiment is thus similar to the preceding one, with the exception that gearing is included to the device. In this manner the user pushes (moves away from the user) the knob instead of pulling (moving towards the user), which may give the possibility to reach a higher level of under-pressure in an easier manner than in the preceding embodiment, depending on the required under-pressure. A release mechanism and a renewed vacuum generation are likewise possible as with the other embodiments.
The details and embodiments explained above in connection to the tenaculum as described in the present claims apply mutatis mutandis to the present tenaculum, where ever applicable. The same applies to the embodiment described above. There are still further options for the vacuum-based tenaculum's structure, which are somewhat similar. Indeed, in a first embodiment, the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- means for moving the piston;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for moving the piston; and
- a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening.
The means for moving the piston comprise at least one part articulately connected to the axle of the piston, articulately meaning that the parts can rotate with respect to each other. Indeed, there is an axle part articulately connected by its first end to the second end of the axle of the piston. This axle part is connected by its second end to a gripping part. The axle part and the gripping part may be integral or they may be made of separate parts that are attached to each other. Typically, the axle part is arranged within the handle part and the gripping part is arranged at least mostly outside the handle part. The gripping part is arranged at such an angle with respect to the vacuum tank and the handle part, that the user can with one hand squeeze the handle part and the gripping part together, thereby moving the axle of the piston such that the piston head is moved from a first end of the vacuum tank to its second end. In a preferred embodiment, the axle part and the gripping part are arranged essentially in a 90° angle with respect one another. The under-pressure is thus created with a pumping movement. In this way the user may easily decide the level of vacuum.
The details and embodiments explained above in connection to the tenaculum as described in the present claims apply mutatis mutandis to the present tenaculum, where ever applicable. The same applies to the other embodiments described above.
In a second embodiment, the tenaculum comprises a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump. The vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- means for moving the piston;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for moving the piston; and
- a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening.
The means for moving the piston is somewhat different in this embodiment. Indeed, it comprises a gear rack (bar-type cogwheel) arranged within the handle part, and to extend towards a second (proximal) end of the handle part. Typically, this gear rack is either arranged in connection with the axle of the piston or the axle of the piston functions as the gear rack, i.e. they are integral. It also comprises a gear (wheel-type cogwheel) arranged in connection with the gear rack, and also arranged within the handle part. A gripping part is connected to the gear and it protrudes from the handle part.
In this embodiment, the under-pressure is generated by pumping several times. Every squeeze of the gripping part rotates the gear which moves on the gear rack, whereby the piston head moves towards the second end of the vacuum tank, thus creating a reduced pressure inside the vacuum tank. Preferably, a ratchet inside the gear allows rotary motion only in one direction. When the gripping part returns to its original position the reduced pressure thus remains inside the tank. The gripping part returns to its starting position by a spring force. In this embodiment, the force needed for creating a suitable under-pressure is decreased compared to the preceding embodiment. The tenaculum also preferably comprises means for releasing the under-pressure from the vacuum tank, for example by releasing the gear from the gear rack, thereby allowing the piston head to move back towards the first end of the vacuum tank, and to thus release the suction head. This embodiment also allows an easy control of the amount of under- pressure in the vacuum tank.
The details and embodiments explained above in connection to the tenaculum as described in the present claims apply mutatis mutandis to the present tenaculum, where ever applicable. The same applies to the other embodiments described above. DETAILED DESCRIPTION OF THE DRAWINGS
Figures 1A to ID illustrate a tenaculum according to an embodiment. The tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. A vacuum pump is inside the handle part and thus not visible in this Figure. The means for compressing the spring 4 is partly visible at a second end 3b of the handle part 3, the second end 3b being opposite a first end 3a, to which the suction tube 2 is connected.
When the user wishes to start using the tenaculum, she/he pushes to means for compressing the spring 4 in the direction of arrow 5. In Figure IB, the means for compressing the spring 4 is shown in the position where the spring is compressed, i.e. the means is mostly inside the handle part 3. A button 6 is in an upper position, compared to its position in Figure 1A. This upper position shows that the spring is locked to the compressed position. Once the suction head 1 is properly placed, the user pushes the button 6 in the direction of the arrow 7, thus releasing the spring and allowing the means for compressing the spring 4 to return to its original position, along an arrow 8. An under-pressure has now been created in the vacuum chamber and the tenaculum is pulling the cervix channel. When the operation is finished and the tenaculum is no longer needed, the user pulls a cover 9 towards the second end of the handle, in the direction of an arrow 10, thereby exposing an air inlet opening 11 (as shown in Fig. 1 c and d). The air inlet opening 11 is in gas communication with the vacuum tank, and air can then enter the vacuum tank and from there the suction tube 2 and the suction head 1, thus releasing the tenaculum. Figure 2 illustrates a cross-sectional view of the tenaculum of Figure 1. It shows a vacuum tank 12, a piston head 13 therein and a seal 14 arranged around the piston head 13. The piston head is attached to an axle 15, which is in turn attached to the means for compressing the spring 4 and arranged inside a spring 16. The Figure further shows the button 6 and a small spring 17 underneath the button 6. Moreover, the Figure shows a spring chamber 8, wherein the spring (16) is arranged.
Figure 3 illustrates an exploded view of the tenaculum of Figure 1. The Figure shows the various parts of the tenaculum, i.e. the suction head 1, the suction tube 2, the handle part 3, the means for compressing the spring 4, the button 6, the cover 9, the air inlet opening 11, the vacuum tank 12, the piston head 13, the seal 14, the axle 15, the spring 16 and the small spring 17. The Figure further shows a gripping ridge 18 designed to facilitate the moving of the cover 9 by the user. Similarly, notches 19 are shown in the axle 15, for locking and releasing the spring in cooperation with the button 6.
Figures 4A-4D illustrate a tenaculum according to another embodiment. In this embodiment, the tenaculum has a similar suction head 1, suction tube 2 and handle part 3 as in the preceding embodiment. The means for compressing the spring 20 is moved in the direction of the arrow 24 for compressing the spring (inside the handle part 3) and locked in place automatically. A third opening is arranged in the handle part 3, covered by a third cover 23, made of an elastic material. The handle part 3 comprises also a cover 22 and a button 21 as part of means for releasing the spring.
The user thus compresses the spring by pushing the means for compressing the spring 20 in the direction of the arrow 24. To release the spring, the user pushes the button 21 in the direction of the arrow 25 (Figure 4B). Thereafter, the means for compressing the spring 20 is moved in the direction of the arrow 26, i.e. in an opposite direction to that of the compression. The third cover 23, also called a pressure indication dome, is then buckled inwardly, showing that an under- pressure is created within the vacuum tank. To release the tenaculum, the cover 22 is moved in the direction of the arrow 27 (or in the opposite direction), thus exposing an opening 28 allowing air to enter the vacuum tank.
Figure 5 illustrates a cross-sectional view of the tenaculum of Figure 4. As can be seen, in this embodiment a spring 28 is arranged within the vacuum tank 29, as is a volume reducer 30. A piston head 31 is equipped with a seal 32 and attached to an axle 33. A small spring 34 is arranged below the button 21. The Figure further illustrates the third cover 23, a cover 22 and an opening 48, allowing air to enter the vacuum tank 29 when the cover 22 is moved. The axle 33 further comprises notches 35 designed to cooperate with the button 21.
Figures 6A-6B illustrate a tenaculum according to yet another embodiment. The tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. The handle part comprises an opening 45 having a first end 45a and a second end 45b. In this opening 45, a knob 40 is arranged to move in the direction of the arrow 46, as well as in the opposite direction, as is shown in more detail in Figure 7. Figure 7 is a cross-sectional view of the tenaculum of Figure 6 (i.e. Figures 6A and 6B) and shows a vacuum tank 41 with a piston head 42 arranged therein. The piston head 42 comprises a seal 43 and is attached to an axle 44. The axle 44 is attached to the knob 40 (means for moving the piston) such that when the knob 40 is moved, the piston head 42 is also moved. Prior to use of the tenaculum, the knob is moved to the first end 45a and preferably abuts against this end of the opening 45. At this moment, the piston head 42 is at a first end 41a of the vacuum tank 41. The user then pulls the knob 40 in the direction of the arrow 46, whereby the piston head 42 moves also in the same direction, shown with the arrow 47. This movement is carried out until the knob 40 abuts the second end 45b of the opening 45. Thereafter, it is either mechanically locked there or kept there manually during the operation, i.e. until the tenaculum is no longer needed.
Figures 8A-8B illustrate a tenaculum according to a further embodiment. This embodiment is similar to that of Figures 6 and 7, and the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. The handle part comprises an opening 51 having a first end 51a and a second end 51b. In this opening 51, a knob 50 (means for moving the piston) is arranged to move in the direction of the arrow
52, as well as in the opposite direction, as is shown in more detail in Figure 9. Figure 9 is a cross-sectional view of the tenaculum of Figure 8
(i.e. Figures 8A and 8B) and shows a vacuum tank 53 with a piston head 54 arranged therein. The piston head 54 comprises a seal 55 and is attached to an axle (not visible in the Figure). The axle comprises a gear rack, designed to cooperate with a wheel 56 arranged in the knob 50.
Prior to use of the tenaculum, the knob 50 is moved to the second end 51b and preferably abuts against this end of the opening 54. At this moment, the piston head 54 is at a first end 53a of the vacuum tank
53. The user then pushes the knob 45 in the direction of the arrow 52, whereby the piston head 54 moves in the opposite direction, shown with the arrow 57, i.e. the cogwheel system (wheel 56 and the axle) reverses the movement. This movement is carried out until the knob 50 abuts the first end 51a of the opening 51. Thereafter, the knob is mechanically locked there, using the locking button 58. Figure 10 illustrates a cross-sectional view of a still further tenaculum according to an embodiment. Also this tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. A vacuum pump arranged inside the handle part 3 comprises a vacuum tank 60. A piston head 61 with its seal 62 is moveably arranged within the vacuum tank 60 and attached to an axle 63. The means for moving the piston comprises an axle part 64 articulately connected by its first end 64a to the second end of the axle 63 of the piston. This axle part 64 is connected by its second end to a gripping part 65. The gripping part 65 is arranged at such an angle with respect to the vacuum tank 60 and the handle part 3, that the user can with one hand squeeze the handle part 3 and the gripping part 65 together, thereby moving the axle 63 of the piston in the direction of the arrow 66 such that the piston head 61 is moved from a first end of the vacuum tank 60 to its second end. Figures 11A-11C illustrate cross-sectional views of another tenaculum according to an embodiment. This embodiment is similar to that shown in Figure 10, except for the manner the piston head is mover. Indeed, the tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. A vacuum pump arranged inside the handle part 3 comprises a vacuum tank 70. A piston head 71 with its seal 72 is moveably arranged within the vacuum tank 70 and attached to an axle 73. The axle 73 is in the form of a gear rack designed to cooperate with a means for moving the piston. The means for moving the piston comprises a gear 74 (wheel-type cogwheel) arranged in connection with the gear rack 73 (i.e. the axle of the piston), and also arranged within the handle part 3. A gripping part 75 is connected to the gear 74 and protrudes from the handle part 3.
In this embodiment, the under-pressure is generated by pumping several times, i.e. moving the gripping part 75 in the direction of the arrow 78. Every squeeze of the gripping part 75 rotates the gear 74 which moves on the gear rack 73, whereby the piston head 71 moves along the arrow 76, 79, thus creating a reduced pressure inside the vacuum tank 70. A ratchet 77 inside the gear allows rotary motion only in one direction. When the gripping part 75 returns to its original position (as shown in Figure 11A) the reduced pressure thus remains inside the tank. The gripping part 75 returns to its starting position by a spring force.
Figures 12A to 12D illustrate a tenaculum according to a further embodiment of the invention. The tenaculum comprises a suction head 1, a suction tube 2 and a handle part 3. A vacuum pump is inside the handle part and thus not visible in this Figure. The means for compressing the spring 4 is partly visible at a second end 3b of the handle part 3, the second end 3b being opposite a first end 3a, to which the suction tube 2 is connected.
When the user wishes to start using the tenaculum, she/he pushes to means for compressing the spring 4 in the direction of arrow 5. In Figure 12B, the means for compressing the spring 4 is shown in the position where the spring is compressed, i.e. the means is mostly inside the handle part 3. A button 6 is in an upper position, compared to its position in Figure 12A. This upper position shows that the spring is locked to the compressed position.
Once the suction head 1 is properly placed, the user pushes the button 6 in the direction of the arrow 7, thus releasing the spring and allowing the means for compressing the spring 4 to return to its original position, along an arrow 8. An under-pressure has now been created in the vacuum chamber and the tenaculum is pulling the cervix channel. When the operation is finished and the tenaculum is no longer needed, the user pushes a cover which is according to this embodiment shaped as a slider 91 towards the first end of the handle, in the direction of an arrow 10, thereby exposing an air inlet opening 11 (as shown in Fig. 12 c and d). The air inlet opening 11 (details are shown in zoomed detailed picture of Fig. 12D) is in gas communication with the vacuum tank, and air can then enter the vacuum tank and from there into the suction tube 2 and the suction head 1, thus releasing the tenaculum. The slider can have gripping ridges 18. The air inlet opening 11 is encircled by a seal 14a in ring or tape.
Figure 13A to 13C illustrate a cross-sectional view of the tenaculum of Figure 12A to 12D. It shows a vacuum tank 12, a piston head 13 therein and a seal 14a arranged around the piston head 13, whereby the seal is optional if an air-tight connection between piston head and the wall of the vacuum tank is guaranteed. The piston head is attached to an axle 15 with a notch 19, which is in turn attached to the means for compressing the spring 4 and arranged inside a spring 16. The Figure further shows the button 6 and a small spring 17 underneath the button 6. Moreover, the Figure shows a spring chamber 8, wherein the spring is arranged and the slider 91 for releasing the vacuum from the vacuum tank and thus the tenaculum.
Figure 14 illustrates an exploded view of the tenaculum of Figure 13 (A to C). The Figure shows the various parts of the tenaculum, i.e. the suction head 1, the suction tube 2, the handle part 3, the means for compressing the spring 4, the button 6, the cover in form of a slider 91, the air inlet opening 11, the vacuum tank 12, the piston head 13, the seal 14, the axle 15, the spring 16 and the small spring 17. The Figure further shows a gripping ridge 18 designed to facilitate the moving of the cover/slider 91 by the user. In this embodiment only one notch 19 is present at the distal end of the axle 15, for locking and releasing the spring in cooperation with the button 6. The Figure furthermore shows the seal 14a on the piston head 13 to ensure an air tight connection between the piston head and the wall of the vacuum tank and a further seal 14a which is needed to seal the air inlet opening 11. A second spring 16a is pressing the cover/slider 91 on the air inlet opening 11 in the home position. The vacuum tube tip can be manufactured as an individual component, as shown in Fig. 14 and marked with reference sign 81 or it can be an overall part of the vacuum tank (12, 41, 53, 70. For production-orientated reasons it is preferred to manufacture the vacuum tube tip as an individual part.
Figures 15A is a detailed view of the second end of the handle. It shows in detail the suction tube 2 the cover/slider 91, the tip lock 80 which seals the air inlet opening 11 on the front surface and the vacuum tube tip 81.
In the zoomed detail pins are shown which lock the tip lock (80) on to the vacuum tube tip (81 ). The tip lock 80 pushes the slider for the pressure release (91 ) and the seal tape (14a) which is mounted on the slider (91 ) against the vacuum tube tip (81 ) via spring (16a). Figures 15B and 15C show a cross-sectional view of Figure 15A. 14a marks the seal which guarantees an air tight closing of the air inlet opening 11 and a second spring 16a which compresses the cover/slider 91 to the air inlet opening 11 in the home position (Fig 15B).
Figure 15C illustrates the air inlet opening 11 in the open position by moving the cover/slider 91 to the proximal end of the tenaculum. A seal ring or seal tape 14a is added between the vacuum tube tip and the cover/slider which moves the pressure release mechanism.

Claims

1. A tenaculum comprising a suction head and a handle part connected to each other by a suction tube, the handle part comprising a vacuum pump, characterised in that the vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
- a spring;
- means for compressing the spring;
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring;
- a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening; the spring being arranged to move the piston head.
2. A tenaculum according to claim 1, further comprising a spring chamber, wherein the spring is arranged within the spring chamber and the axle of the piston is arranged to extend to the spring chamber via the second opening of the vacuum tank.
3. A tenaculum according to claim 1, wherein the spring is arranged within the vacuum tank.
4. A tenaculum according to any of the preceding claims, further comprising means for releasably locking the spring in its compressed position and means for releasing the spring from its compressed position.
5. A tenaculum according to claim 4, wherein the axle is provided with notches configured to cooperate with the means for releasably locking the spring and/or with the means for releasing the spring .
6. A tenaculum according to claim 4 or 5, wherein the means for releasing the spring is integrated with the means for locking the spring.
7. A tenaculum according to any one of the claims 4-6, wherein the means for releasing the spring is arranged to be set in one position to create the maximal under-pressure to the suction tube and the suction head.
8. A tenaculum according to any one of the claims 4-6, wherein the means for releasing the spring is arranged to be set at two different positions to create at least two different levels of under-pressure to the suction tube and the suction head.
9. A tenaculum according to any of the preceding claims, wherein the vacuum tank comprises an air inlet opening, covered by a moveable cover.
10. A tenaculum according to claim 9, wherein the cover is in the form of a ring moveably arranged on the handle part.
11. A tenaculum according to claim 9, wherein the cover is in the form of a slider moveably arranged on the handle part, wherein the slider exposes an air inlet opening which is in gas communication with the vacuum tank.
12. A tenaculum according to any of the preceding claims, wherein the vacuum tank comprises a third opening, the third opening being covered by a cover, and the cover being configured to deform under the vacuum created in the vacuum tank.
13. A tenaculum according to any of the preceding claims, wherein the spring is configured to provide an pressure of 0.5-0.8 bar in the vacuum tan k.
14. A tenaculum according to any of the preceding claims, wherein at least two of the suction head, the suction tube and the handle part are detachably connected to each other.
15. A tenaculum according to any of the preceding claims, wherein the size of the vacuum tank is 5-25 ml.
16. A vacuum pump for a tenaculum with a suction head which is connected with the vacuum pump via a suction tube, characterised in that the vacuum pump comprises
- a vacuum tank comprising a first opening at its first end and a second opening at its second end, wherein the suction tube is connected to the first opening;
- a spring;
- means for compressing the spring;
- a piston comprising
- a piston head moveably arranged within the vacuum tank;
- an axle having a first end and a second end, its first end being connected to the piston head and its second end being connected to the means for compressing the spring;
- a pressure seal arranged on the piston head to isolate a vacuum space of the vacuum tank from the second opening; the spring being arranged to move the piston head.
17. A vacuum pump for a tenaculum according to claim 16, further comprising a spring chamber, wherein the spring is arranged within the spring chamber and the axle of the piston is arranged to extend to the spring chamber via the second opening of the vacuum tank.
18. A vacuum pump for a tenaculum according to claim 16, wherein the spring is arranged within the vacuum tank.
19. A vacuum pump for a tenaculum according to claims 16-18, further comprising means for releasably locking the spring in its compressed position and means for releasing the spring from its compressed position.
20. A vacuum pump for a tenaculum according to claim 19, wherein the axle is provided with notches configured to cooperate with the means for releasably locking the spring and/or with the means for releasing the spring.
21. A vacuum pump for a tenaculum according to claim 19 or 20, wherein the means for releasing the spring is integrated with the means for locking the spring.
22. A vacuum pump for a tenaculum according to any one of the claims 19-21, wherein the means for releasing the spring is arranged to be set in one position to create the maximal under-pressure to the suction tube and the suction head.
23. A vacuum pump for a tenaculum according to any one of the claims 19-21, wherein the means for releasing the spring is arranged to be set at two different positions to create at least two different levels of under- pressure to the suction tu be and the suction head .
24. A vacuum pump for a tenaculum according to any of the claims 16- 23, wherein the vacuum tank comprises an air inlet opening, covered by a moveable cover.
25. A vacuum pump for a tenaculum according to claim 24, wherein the cover is in the form of a ring moveably arranged on the handle part.
26. A vacuum pump for a tenaculum according to claim 24, wherein the cover is in the form of a slider moveably arranged on the handle part, wherein the slider exposes an air inlet opening which is in gas communication with the vacuum tank.
27. A vacuum pump for a tenaculum according to any of the claims 16-
26, wherein the vacuum tank comprises a third opening, the third opening being covered by a cover, and the cover being configured to deform under the vacuum created in the vacuum tank.
28. A vacuum pump for a tenaculum according to any of the claims 16- 27, wherein the spring is configured to provide an pressure of 0.5-0.8 bar in the vacuum tank.
29. A vacuum pump for a tenaculum according to any of the claims 16-
28, wherein at least two of the suction head, the suction tube and the handle part are detachably connected to each other.
30. A vacuum pump for a tenaculum according to any of the claims 16-
29, wherein the size of the vacuum tank is 5-25 ml.
PCT/EP2019/067847 2018-07-10 2019-07-03 A vacuum-based tenaculum WO2020011616A1 (en)

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EP18182733 2018-07-10
EP18182733.8 2018-07-10

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TW (1) TW202012008A (en)
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WO2023006571A2 (en) 2021-07-29 2023-02-02 Aspivix Sa Handheld gynecological device, handle and rod member
CN117618091A (en) * 2023-12-20 2024-03-01 江苏康进医疗器材有限公司 Disposable manual abortion aspirator

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WO2023006571A2 (en) 2021-07-29 2023-02-02 Aspivix Sa Handheld gynecological device, handle and rod member
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CN117618091A (en) * 2023-12-20 2024-03-01 江苏康进医疗器材有限公司 Disposable manual abortion aspirator

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TW202012008A (en) 2020-04-01
UY38298A (en) 2020-01-31

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