WO2020182535A1

WO2020182535A1 - Uterine sound tube with anaesthetic applicator

Info

Publication number: WO2020182535A1
Application number: PCT/EP2020/055516
Authority: WO
Inventors: Taina TJÄDER; Christine Talling; Heikki Salo; Marina ALLEN; Mira KAUTTO; Bernhard Lindenthal; Afra TORGE
Original assignee: Bayer Oy
Priority date: 2019-03-08
Filing date: 2020-03-03
Publication date: 2020-09-17
Also published as: TW202100102A; AR118279A1

Abstract

Disclosed is a sound applicator (100, 1000, 1100, 1200, 1300, 1400) comprising a handle (102, 1002, 1102, 1202, 1302, 1402) and a sound tube (116, 602, 1004, 1104, 1204, 1304, 1404). The handle has a proximal end (104, 1210) and a distal end (106, 1212), and comprises a container (108, 1020, 1312, 1406) for an anaesthetic product (814) and a means (110, 1018, 1106, 1206) for discharging the anaesthetic product from the container. The sound tube has a proximal end (118) and a distal end (120), having length L. The proximal end of the sound tube is attachable to the distal end of the handle for allowing the anaesthetic product to enter the sound tube. The sound tube comprises openings (122) arranged along a distance D from its distal end. The present disclosure also provides a kit for a sound applicator.

Description

UTERINE SOUND TUBE WITH ANAESTHETIC APPLICATOR

TECHNICAL FIELD

The present disclosure relates generally to a gynaecological equipment, and more specifically to sound applicators. Furthermore, the present disclosure relates to kits for sound applicators.

BACKGROUND

In many gynaecological procedures, a sound device, also known as a uterine sound, is used to measure the length of the uterus of a subject. Such measurements are usually performed by a health care professional to prevent an accidental perforation of the uterus during a subsequent medical procedure. For example, measurement of the length of the women's uterus may be required prior to insertion of an intrauterine system (IUS) or an intrauterine device (IUD) into the uterus (in the following, the abbreviation IUS is used, and covers both IUS's and IUD's). The IUS (or the IUD), is a common reversible form of contraception, usually positioned into a uterus using an inserter.

Typically, the measurement of depth of the uterus using a conventional sound device requires an experienced health care professional to accurately perform it.

Moreover, it is known that the insertion of the IUS using an insertion tube of the inserter in the cervix region is usually a painful experience for a subject due to the anatomical structure of the cervix and the uterus. For example, the diameter of the insertion tube employed to introduce the IUS in the uterus may be incompatible with a cervix opening or the overall cervix region of the subject causing unnecessary pain in the IUS insertion process. Furthermore, the cervix may be in an angle that is different from the insertion tube of the IUS. Thus, if the cervix is not properly straightened, the user might hit the cervix wall with insertion tube causing pain or even perforation. The pain and discomfort for a subject increases manifold with the increase in the preparatory and operational steps.

In rare cases, an anaesthetic injection may be prepared and injected to a subject before the sound device is actually inserted. Additionally, there is a time gap before the injected anaesthesia manifests its action. Consequently, the process of measurement of the length of the uterus using a conventional sounding device and further the IUS insertion process using the inserter may get delayed, which is not desirable.

Therefore, in light of the foregoing discussion, there exists a need to overcome the aforementioned drawbacks associated with the measurement the length of the uterus using a conventional sound device. SUMMARY

The present disclosure seeks to provide a sound applicator. The present disclosure also seeks to provide a kit for a sound applicator. The present disclosure seeks to provide a solution to the existing problem of pain and discomfort experienced by a subject during measurement of the depth of a uterus.

An aim of the present disclosure is to provide a solution that overcomes at least partially the problems encountered in prior art, and provides a multipurpose and efficient sound applicator that is easy-to-use, enables fast onset of pain release, and provides a relatively more comfortable experience during the measurement of the length of the uterus and the cervical canal, as compared to existing systems or devices. A still further aim is to provide a solution to easily manage pain during any subsequent gynaecological procedure. In one aspect, an embodiment of the present disclosure provides a sound applicator comprising

- a handle

- having a proximal end and a distal end,

- comprising a container for an anaesthetic product, and

- comprising means for discharging the anaesthetic product from the container,

- a sound tube

- having a proximal end and a distal end, distance between the proximal end and the distal end defining length L of the sound tube,

- the proximal end of the sound tube being attachable to the distal end of the handle for allowing the local anaesthetic product to enter the sound tube, and

- the sound tube comprising a number of openings arranged along a distance D from its distal end, D being at least 10 % of L.

In another aspect, an embodiment of the present disclosure provides a kit for a sound applicator comprising

- a container comprising an anaesthetic product,

- a handle

- having a proximal end and a distal end,

- configured to house the container of anaesthetic product, and

- comprising means for discharging the anaesthetic product from the container,

- a sound tube

- the sound tube comprising a number of openings arranged along a distance D from its distal end, D being at least 10 % of L. Embodiments of the present disclosure substantially eliminate or at least partially address the aforementioned problems in the prior art, and enable the disclosed sound applicator to be conveniently and efficiently used for measurement of the length of the uterus and the cervical canal and simultaneously release an anaesthetic product into the cervical canal of a subject to reduce the pain associated with the measurement and subsequent medical procedure related to uterus (e.g. IUS placement into the uterus). Moreover, the present disclosure allows easy and efficient administration of an anaesthetic to the cervix canal, which is not possible with the presently known devices. Indeed, the cervix has a lot of nerves and thus is a sensitive area. Using known devices, an anaesthetic is typically applied only to the vaginal area and the portio, which is not very effective for pain management. With the present device, an anaesthetic product can be applied on the whole length of the cervix canal. Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiments construed in conjunction with the appended claims that follow.

It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those skilled in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.

Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein: FIG. 1 is a perspective view of a sound applicator, in accordance with an embodiment of the present disclosure;

FIG. 2 is a perspective view of the sound applicator of FIG. 1 and an exemplary sales packaging of the sound applicator, in accordance with an embodiment of the present disclosure; FIG. 3 is a perspective view of the sound applicator with a flange, in accordance with an embodiment of the present disclosure;

FIGs. 4A and 4B are perspective views of an exemplary implementation of a handle with and without a removable cap, in accordance with an embodiment of the present disclosure; FIG. 5 is a perspective view of the sound applicator of FIG. 3 with an exemplary sound tube that is yet to be attached to a handle, in accordance with another embodiment of the present disclosure;

FIG. 6 is a perspective view of the exemplary sound applicator with another exemplary sound tube that is yet to be attached to the handle, in accordance with an embodiment of the present disclosure;

FIGs. 7A-7E are schematic views of different arrangement of openings along a certain distance from the distal end of the sound tube, in accordance with various embodiments of the present disclosure; FIGs. 8A-8G are perspective views of a sound applicator with a flange, depicting various operational stages thereof, in accordance with an embodiment of the present disclosure;

FIGs. 9A and 9B are perspective views of a sound applicator, depicting various ways of recording measurements of the length of uterus and cervical canal using different flanges, in accordance with various embodiments of the present disclosure;

FIGs. 10A and 10B are perspective views of a sound applicator with a handle in a disengaged and an engaged state, respectively, in accordance with another embodiment of the present disclosure;

FIG. 11 is a perspective view of a sound applicator, in accordance with yet another embodiment of the present disclosure;

FIGs. 12A and 12B are perspective and cross-sectional views of a sound applicator, respectively, in accordance with still another embodiment of the present disclosure;

FIGs. 13A and 13B are perspective views of a sound applicator in an assembled and unassembled states, respectively, in accordance with yet another embodiment of the present disclosure;

FIGs. 14A and 14B are perspective views of a sound applicator in an assembled and unassembled states, respectively, in accordance with still another embodiment of the present disclosure;

FIGs. 15A and 15B are perspective views of a sound applicator in an unassembled and assembled states, respectively, in accordance with yet another embodiment of the present disclosure; FIGs. 16A and 16B are perspective views of a sound applicator in an unassembled and assembled states, respectively, in accordance with still another embodiment of the present disclosure; and FIGs. 17A and 17B are perspective views of a sound applicator in an unassembled and assembled states, respectively, in accordance with yet another embodiment of the present disclosure.

In the accompanying drawings, an underlined number is employed to represent an item over which the underlined number is positioned or an item to which the underlined number is adjacent. A non-underlined number relates to an item identified by a line linking the non-underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the non-underlined number is used to identify a general item at which the arrow is pointing.

DETAILED DESCRIPTION OF EMBODIMENTS

The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practicing the present disclosure are also possible.

In one aspect, an embodiment of the present disclosure provides a sound applicator comprising

- a handle

- having a proximal end and a distal end,

- comprising a container for an anaesthetic product, and

- comprising means for discharging the anaesthetic product from the container,

- a sound tube

- the proximal end of the sound tube being attachable to the distal end of the handle for allowing the anaesthetic product to enter the sound tube, and - the sound tube comprising a number of openings arranged along a distance D from its distal end, D being at least 10 % of L.

- a container comprising an anaesthetic product,

- a handle

- having a proximal end and a distal end,

- configured to house the container of anaesthetic product, and

- comprising means for discharging the anaesthetic product from the container,

- a sound tube

- the proximal end of the sound tube being attachable to the distal end of the handle for allowing the anaesthetic product to enter the sound tube, and

Throughout the present disclosure, the term "sound" or "sounding" as used herein does not refer to audible sound waves, but to means of detecting objects and measuring distances (or depths). Sound refers to a long, thin rod, often made of an inert material, for example, a polymeric material (e.g. plastic) or surgical steel, operable to be inserted into the urethral opening and towards deeper organs, such as, for example, a uterus. In medicine, the sound is utilized to gently probe, unblock, or expand a passage inside human body, such as cervical canal.

Throughout the present disclosure, the term "sound applicator" as used herein refers to a dual function medical instrument intended for measuring the anatomical length of uterine cavity as well as cervical canal length in a primary function, and further to administer a liquid or semisolid composition comprising a therapeutically active agent, such as anaesthetic product, hormones, or other drugs, at a site of action, such as a cervical canal, in a secondary function. The sound applicator enables the administration of the liquid or semisolid composition during the sounding procedure, that is, during the process of measurement of the anatomical length of uterine cavity plus the length of the cervical canal. Alternatively stated, the sound applicator is a specialized multipurpose medical instrument that not only measures a combined length of the uterine cavity as well as the cervical canal, prior to a certain medical procedure, for example, insertion of a long-acting reversible contraceptive such as an IUS, but also simultaneously administers an anaesthetic product (or a lubricating gel containing an anaesthetic product) into the cervical canal to reduce pain associated with the clinical procedure, i.e. long-acting reversible contraceptive placement into the woman's uterus. It will be appreciated that the sound applicator may also be used as a precursor to various other medical procedures that require at least the measurement of the length (i.e. depth) of uterine cavity and the cervical canal length. Examples of such medical procedures include, but are not limited to hysterectomy, hysteroscopy, dilation and curettage, and artificial insemination.

Moreover, the sound applicator is used to check the patency of the cervix. Notably, patency of cervix refers to the degree of identifying cervix in an open or unobstructed condition and the condition of showing detectable parasitic infection in cervix or area surrounding the cervix. It will be appreciated that patency of cervix governs the success of a subsequent medical procedure, such as the IUS insertion. Furthermore, the sound applicator enables determining the cavity direction and detection of any uterine anomaly, for example, a congenital uterine anomaly.

The present disclosure thus provides the aforementioned sound applicator and the aforementioned kit for the sound applicator for efficiently performing a process of measuring the length of the cervical canal plus the length of the uterus. The length of the uterus is also referred to as uterine depth. The sound applicator enables an accurate measurement of length of the cervical canal plus the length of the uterus and simultaneous release of a lubricating gel formulation comprising a quick-action local anaesthetic product directly into the cervical canal of a subject to reduce the pain associated with the length measurement and subsequent medical procedure related to uterus (e.g. IUS placement into the uterus). Moreover, it is believed that the pressure coming from the sound tube (the anaesthetic product exiting the sound tube) towards cervical canal walls might also gently dilatate the cervical canal and thus make it more receptive to the following insertion procedure.

As the sound tube comprises a number of openings that are arranged along the distance D from its distal end, D being at least 10 % of L, a higher concentration of the local anaesthetic product can be directly released in the cervical canal. Thus, the need to administer the anaesthetic product through anaesthetic injections in a separate step to prepare the subject for IUS insertion is not required, thereby saving time and minimizing unnecessary pain and discomfort to the subject. Furthermore, the small cross-section of the sound tube of the sound applicator and administering of an anaesthetic product (or a lubricating product containing an anaesthetic product) makes a subsequent medical procedure near painless. Moreover, the use of aforementioned sound applicator and kit therefore may enable an increase in an overall rate of successful implantation of the intrauterine system without causing any or only minimal discomfort to the subject.

The sound applicator comprises a handle. The handle of the sound applicator has a proximal end and a distal end. The handle enables holding the sound applicator. The handle is preferably designed for easy handling with a single hand. Moreover, the handle may be designed to conform to a palm of an operator, such as a medical practitioner. The proximal end of the handle is held by an operator, such as a medical practitioner, and the distal end of the handle is directed towards the subject, such as a patient. In the present disclosure, the term " subject " or " atient " as used herein refers to a mammal, preferably a woman.

In an embodiment, the handle is fabricated from a polymeric material (e.g. medical-grade plastics material) and is employable for a single use for hygienic purpose. In another embodiment, the handle is fabricated from a metal or an alloy and is employable for multiple uses by sterilization for re-use. The handle may have various shapes and sizes. The handle is typically a hollow elongated structure, for example, tubular, cylindrical, elliptical, oval, cuboidal, or the like.

According to an embodiment, the aforementioned container of the handle is available in various shapes and sizes. Optionally, the container is a tube. More optionally, the container for the anaesthetic product has an elongated, a cylindrical, a cuboidal, or a polygonal tube-shape structure. Moreover, the container may be a deformable pouch of suitable size that is accommodable within the handle. Furthermore, the length of the container may vary according to the dosage of the anaesthetic product needed. For example, the diameter of the container may be in a range of 13.5 millimetre (mm) to 30 mm. In case the container has an oval cross- section, the diameter is the largest dimension of the cross-section. The length of the container may be in a range from 45 mm to 180 mm. The volume of anaesthetic product enclosed may be from 3 millilitre (ml) to 30ml. In an example, a container in the form of a tube with a diameter of 13.5 mm and length in a range of 45 to 90 mm may contain 3 to 8 ml of anaesthetic product. In another example, a container in the form of a tube with a diameter of 16 mm and length in a range of 45 to 105 mm, may contain 5 to 15 ml of anaesthetic product. In yet another example, the volume of the container may be, preferably, 5-10 ml. The volume of the container may be for example from 5, 7, 10, 12, 15, 18, 20 or 25 ml up to 10, 12, 15, 18, 20, 23, 25, 27 or 30 ml.

According to an embodiment, the handle comprises an opening. The opening is present between the proximal end and the distal end of the handle. In such an embodiment, the container for the anaesthetic product is a deformable tube arranged in the opening in the handle. It will be appreciated that the container is fabricated from an inert material that prevents the contents of the container from reacting therewith, as well as resistant to environmental factors, such as for example exposure to light, exposure to reactive gases, absorption of water vapor, and/or microbial contamination, and leakage of contents. Optionally, the container is fabricated from a flexible material, such as plastic material (for example, a low-density polyethylene (LDPE)), an elastomer (for example, a rubber), a silicone, and so forth. Examples of the container includes, but are not limited to an ampule, a tube, a flexible bag, a pouch, a bladder and other types of medical-grade containers suitable to contain the anaesthetic product. Moreover, the container needs to be both sterilisable and able to maintain sterility.

In an embodiment, the container is prefilled (or pre-loaded) with the anaesthetic product. It will be appreciated that the anaesthetic product is filled in the container under the good manufacturing practice regulations used for the control of drug product containers and closures. In an example, the handle comprising the container prefilled with the anaesthetic product is provided in a closed sales package. Such containers are commercially available, i.a. from Hoffmann Neopack. The closed sales package protects its contents from environmental and mechanical factors. In another example, the container prefilled with the anaesthetic product may be provided as sealed or closed pack, separate from the sales package comprising the handle and the sound tube (i.e. two separate sales packages). In yet another example, all the components, i.e., the container prefilled with the anaesthetic product, the handle, and the sound tube may be provided in same closed sales package.

Optionally, the anaesthetic product is in the form selected from a gel, a thermogelling liquid and a cream. The anaesthetic product in the form of the gel, the thermogelling liquid or the cream acts as a local anaesthetic and provides sufficient lubrication at the site of action, the cervical canal. Optionally, the anaesthetic product is a viscous product that enables direct application at the site of action using the sound applicator avoiding a potential leakage (or run-off) therefrom. Additionally, the anaesthetic product has a pH level that is suitable for cervical canal. Moreover, the anaesthetic product may be mucoadhesive and result in an interfacial force with the mucosal lining of the cervical canal. Furthermore, the anaesthetic product may have thermogelling and/or thixotropic properties that enables it to withstand the physiological changes occurring in the human body. A thermogelling product for example is more liquid (i.e. less viscous) in room temperature, and its viscosity is increased (i.e. it solid ifies) when it comes into contact with the body, i.e. at a higher temperature. Furthermore, the anaesthetic product needs naturally to be sterile and have such consistency that it can be sterilised in the container.

Optionally, the anaesthetic product comprises a therapeutically active agent selected from lidocaine and prilocaine. A combination of these active agents can also be used . Lidocaine and prilocaine are amide-type local anaesthetics. Specifically, the therapeutically active agent selected from lidocaine and prilocaine functions by temporarily numbing the cervical canal at the site of application and surrounding area therearound . Beneficially, the area around the site of application of the anaesthetic product may be numb for several hours after the clinical procedure. It will be appreciated that the anaesthetic product comprises a feasible amount of the therapeutically active agent selected from lidocaine and prilocaine. In such case, the container for the anaesthetic product is typically designed to carry only the maximum feasible amount of the therapeutically active agent. However, it will also be appreciated that the dosage and action time of the anaesthetic product is based on the age and medical condition of the subject and the clinical procedure to be performed thereon. In an embodiment, the volume of the container for the anaesthetic product is for example 5-10 ml, preferably 6-7 ml.

According to another embodiment, the anaesthetic product is selected from products commercially sold under the tradenames of EMLA cream® and Oraqix gel®, as disclosed in US 4529601, US 4562060 and EP 0002425 for the EMLA cream® and in WO 97/38675 for Oraqix®.

It will be appreciated that the anaesthetic product has a very fast action time, that is beneficial in relieving pain when the anaesthetic product delivered by use of the sound applicator in the cervical canal. Optionally, the time for onset of action of the anaesthetic product is in a range of 30 seconds (s) to 300 seconds (s). In an example, the time for onset of action may range from 30, 60, 90, 120, 150, 180, 210, 240 or 270 seconds up to 60, 90, 120, 150, 180, 210, 240, 270 or 300 seconds. In another example, and preferably, the time for onset of action of an anaesthetic product may be 30 seconds or less than 30 seconds, such as 5, 10, 15, 20 or 25 seconds.

The handle further comprises a means for discharging the anaesthetic product from the container and into the sound tube. The means for discharging the anaesthetic product from the container exerts pressure on the container to enable squeezing out of the anaesthetic product from the container and consequently administering the anaesthetic product at the site of action. Optionally, the container for the anaesthetic product is deformable by the means for discharging the anaesthetic product from the container. The means for discharging the anaesthetic product from the container controls the movement of the anaesthetic product from the container towards the distal end of the handle and towards the sound tube. Alternatively stated, the pressure exerted by the means for discharging the anaesthetic product from the container deforms the container to enable squeezing out of the anaesthetic product from the container. In an embodiment, the handle comprises markings thereon to guide the user in discharging a suitable amount (e.g. a suitable dosage) of the anaesthetic product from the container. For example, the handle has a scale that defines the volume of the container for the anaesthetic product in the handle. For example, at a position "start" on the markings on the handle, the container has a full volume of the anaesthetic product in the handle, at a position "1/2" on the markings on the handle, the container has one half of the volume of the anaesthetic product in the handle and another half discharged out of the handle. At a position "0" on the markings on the handle, the container has discharged completely the anaesthetic product out of the handle for administering of the anaesthetic product to the delivery site, and the sound applicator is ready to be used for sounding the uterine cavity.

Optionally, the handle, comprising the container for the anaesthetic product and the means for discharging the anaesthetic product from the container, may come in different designs. In an example, the means for discharging the anaesthetic product is a slider arranged in the handle. In an embodiment, the means for discharging the anaesthetic product from the container is a slider arranged in an opening in the handle. Optionally, the handle has a first cover portion (e.g. an upper side) and a second cover portion (e.g. a lower side) that is opposite to the first cover portion. The slider is provided on the first cover portion (e.g. an upper side) and arranged in the opening provided in the first cover portion of the handle. The container for anaesthetic product is arranged beneath the first cover portion of the handle and supported by the second cover portion of the handle. The movement of the slider squeezes the anaesthetic product from the container. Specifically, the anaesthetic product from the container is squeezed by the pressing of the container between the slider and the second cover portion of the handle.

Alternatively, optionally, the slider is arranged on both sides of the handle, i.e. the handle can have two openings, one on the first cover portion (e.g. the upper side) and the other on the second cover portion (e.g. the lower side) of the handle. The sliders on both sides of the handle facilitate the insertion of the sound tube of the sound applicator based on the position of the uterus i.e. anteverted or retroverted uterus, anteflexed or retroflexed uterus, midline uterus or rotated uterus, such as rotating the sound application at an angle of 180°. For example, during the sounding procedure, a health care professional may initially assume the position of the uterus to be anteverted and accordingly hold the handle having a first slider to advance the sound tube of the sound applicator towards the uterus. However, at the time of advancing the sound tube towards the uterus, the health care professional may find that the uterus is in retroverted position. The sound tube may have a slight curvature at its distal end and while advancing the sound tube initially, the curvature of the sound tube may not be compatible with the retroverted position. In such a case, the handle of the sound applicator is rotated by 180° from its original position and release of the anaesthetic product is conveniently executed using a second slider, using one hand.

The sound applicator comprises a sound tube. The sound tube is also the measurement unit that is passed through the cervical canal into the uterus until a tip of the sound tube comes into contact with the fundus of the uterus. The sound tube is used to measure the length of the uterine cavity plus the length of the cervical canal. The sound tube has a predefined length and a predefined circumference that enables the movement of the sound tube through the cervical canal in a comfortable manner. In an embodiment, the sound tube may have a size conforming to the size of the cervical canal, particularly to be easily accommodated in the cervical canal and inserted therethrough into the uterine cavity. Specifically, the sound tube is a hollow long, thin rod, often made of an inert material, for example, a polymeric material (e.g. plastic material) or medical-grade metal. In an embodiment, the sound tube may be made of a medical grade transparent or semi-transparent material, such as a plastic material (for example polyethylene, polypropylene, acrylate or silicone).

The sound tube has a proximal end and a distal end, a distance between the proximal end and the distal end defining a length L of the sound tube. The sound tube is thus a hollow tube-like structure having a length L. Optionally, the length L of the sound tube is in a range of 150 mm to 210 mm, preferably 155-195 mm. The length L of the sound tube typically includes a marking scale thereon to determine the length of the cervical canal and the uterine cavity. As will be discussed below, the measurement may be facilitated by the use of a flange.

Optionally, the sound tube is manufactured in more than one part, such as in two parts, where the proximal end of the sound tube has a larger diameter and the distal end of the sound tube has a smaller diameter as compared to the proximal end. Such a construction may facilitate the movement of the anaesthetic product in the sound tube, as the diameter closer to the handle is larger. Additionally, such a construction may facilitate the manufacturing of the sound applicator. In an example, the proximal end of the sound tube is made by injection moulding and may have an inner diameter of 3 mm and outer diameter of 5 mm. The proximal end of the sound tube has, in this embodiment, a larger diameter as compared to the distal end of the sound tube in order to stand the higher pressure due to the movement of the anaesthetic product from the container upon pressure exerted on the container by the means for d ischarging the anaesthetic product from the container. It will be appreciated that the anaesthetic product is required to travel (i.e. move within the sound tube along the length L) for a sig nificant length from the container through the entire length of the sound tube to the distal end of the sound tube, and that the movement is typically induced by pressure exerted on the container by the means for discharging the anaesthetic product. In an example, the distal part has a smaller diameter, for example an outside d iameter 2.9 mm and an inner diameter of 2 mm, and is slightly protruded at distal end, namely the tip. The slight protrusion, or rounding, of the tip also allows for easier insertion of the sound tube in the cervical canal, and indeed, any sharp edges should preferably be avoided at the distal end of the sound tube. Beneficially, the smaller diameter of the distal end enables minimising pain to the patient during insertion of the sound tube in the cervical canal and into the uterus.

The proximal end of the sound tube is attachable to the d istal end of the handle for allowing the local anaesthetic product to enter the sound tube. In an example, a tubular portion (e.g . a hollow tubular protrusion) may extend from the d istal end of the handle. The proximal end of the sound tube is attached to the handle by engaging to the tubular portion. In an example, the tubular portion refers to a mouth portion (i.e. an opening) of the container protruded from the distal end of the handle to accommodate and engage the proximal end of the sound tube. In another example, the tubular portion may be a flow tube (a separate part) that forms a part of the handle when assembled . In such example, the content of the container is released in the flow tube, and then passes to the proximal end of the sound tube. Alternatively stated, the flow tube receives the anaesthetic product from at least one container and makes way for the anaesthetic product to flow therefrom and into the sound tube. The sound tube receives the anaesthetic product from the container when pressure is exerted on the container by the means for d ischarging the anaesthetic product.

The sound tube is typically to be retained in a fixed position within the handle to enable safe insertion of the sound tube into the uterus. Therefore, the tubular portion and the proximal end of the sound tube typically include an attachment mechanism that retains the proximal end of the sound tube coupled to the distal end of the handle. For example, the attachment mechanism may be a thread-based locking mechanism. In the thread-based locking mechanism, the proximal end of sound tube may have a first thread pattern and the tubular portion has a second thread pattern that is compatible and complimentary to the first thread pattern to be locked . Thus, the proximal end of sound tube is attached to the distal end of the handle by locking, using the thread-based locking mechanism. The locking occurs in such a way that the sound tube remains immobile in relation to the handle.

Optionally, the attachment mechanism is a bayonet coupling, a conical coupling or a Luer Lock. Indeed, any ISO-standard ised attachment or lock mechanism can be used . It is still further possible that the attachment mechanism is made separately and the three parts, i.e. the proximal end of the sound tube, the distal end of the sound tube (when the sound tube is in two parts) and the attachment mechanism (e.g . the flow tube), are then assembled before attachment of the sound tube to the distal end of the handle or packaging in the sales package. Optionally, the attachment mechanism causes the curvature of the sound tube to be oriented in a suitable position with respect to the hand le and the means for discharging the anaesthetic product. Moreover, the attachment mechanism is preferably operable to fit the proximal end of the sound tube and the distal end of the handle with one another in only one configuration, followed by twisting both the parts to lock with each other. For example, the handle may include slots at its distal end. The slots of the handle allow the proximal end of the sound tube to be put into contact with the handle in only one way, followed by twisting to lock the parts with each other.

According to an embodiment, the sound tube is preferably slightly curved at its distal end. The curvature is suitable to conform to the anatomical structure of the uterus and to enable the sound tube to be inserted through the cervical canal and into the uterus without causing pain to the subject. In an example, when the sound applicator is placed on a horizontal surface with the tip of the sound tube facing upwards (i.e. away from the horizontal surface), the curved distal end (or the tip of the sound tube) is 10-40 mm away from the horizontal surface.

The sound tube comprises a number (i.e. plurality) of openings arranged along the distance D from its distal end, D being at least 10 % of L. The distal end of the sound tube is at least mostly closed and rounded. However, a part of the distal end of the sound tube comprises the plurality of openings (namely, perforations) along the distance D from its distal end, i.e. from the tip of the sound tube. The distance D is at least 10 % of the length L of the sound tube. In an example, the distance D is in a range of 1.3-4 centimetre (cm). Preferably, the plurality of openings may be arranged along a distance of at least 3 cm from the distal end, i.e. the average length of the cervical canal. The distance D is typically from 10, 12, 14, 15, 17, 20, 22, 25, 28, 30, 35, 40 or 50 % up to 12, 14, 15, 17, 20, 22, 25, 28, 30, 35, 40, 45, 50 or 55 % of the length L of the sound tube.

According to an embodiment, the sound tube is made by extrusion and the plurality of openings are then, for example, drilled along the distance D from its distal end. Moreover, the openings are drilled in a manner that the openings pass through the wall thickness of the sound tube generating a perforated sound tube along the distance D from its distal end. Beneficially, the plurality of openings at the distal end are employed for releasing the anaesthetic product directly at the delivery site, i.e., cervix opening and the cervical canal, of a subject.

It will be appreciated that the plurality of openings in the distal end of the sound tube may vary in terms of density (or quantity), placement, shape and size. Optionally, the openings are round perforations. Notably, the size, the number of openings, the arrangement of the openings, or even the structure of the sound tube depends on the viscosity and thixotropy of the anaesthetic product selected for use in a specific sound applicator. For example, the size of the openings may be 2x1 mm and the size of the openings may increase towards the distal end of the sound tube (so as to facilitate the movement of the anaesthetic product along the whole length of the sound tube). Similarly, the density of openings (i.e. number of openings) may increase towards the distal end of the sound tube. For example, in case there are openings only on two diametrically opposed sides of the tube, the layout of openings is arranged such that the two openings that are closest to the proximal end of the sound tube may have a diameter for example of 0.4 mm on each side (i.e. 0.4 mm per side of the two diametrically opposed sides) and four openings near the middle of the distal end of the sound tube may have a diameter, for example, of 0.6 mm on each side, and about six openings closest to the tip of the sound tube may have a diameter, for example, of 0.8 mm each side.

Optionally, one or more openings are provided at the tip of the sound tube to facilitate direct delivery of the quick action local anaesthetic product or lubricating gel comprising the anaesthetic product to the cervical canal so that the subsequent movement of the sound tube in the cervical canal is painless or less painful. It is possible that during the prefilling phase of the sound tube small droplets come out of the plurality of openings of the sound tube and thus lubricate it, consequently further easing its insertion into the cervical canal.

Optionally, the tip of the sound tube is smooth and curved (e.g. a semi circular or rounded tip) to facilitate smooth and frictionless movement of the sound tube into and out of the cervical canal, and avoid any risk of perforation of the fundus of the uterus. In other words, the rounded tip ensures safety of the fundus region of uterus. Furthermore, the tip has various forms, for example, a solid closed tip or a tip with one or more openings. Optionally, the tip of the sound tube is precoated with the anaesthetic product to facilitate a comfortable insertion of the sound tube through the cervical canal. In an example, the tip of the sound tube may be lubricated with the help of the sales package. The tip of the sound tube may be dipped in a recess of the sales package, where the anaesthetic product spreads constantly all over the distal end of the sound tube. Consequently, the lubricated tip of the sound tube facilitates a painless or less painful and smooth movement of the sound tube through the cervical canal and into the uterus.

Optionally, the sound tube has a circular cross-section. It is to be appreciated that the cross-sectional shape of the sound tube may vary. For example, the sound tube may have an oval or a polygonal shape as long as the shape is suitable to be inserted into the cervical canal and into the uterus. Additionally, optionally, the sound tube is waved either along the cross-section or along a specified distance from its distal end. In an example, the specified distance from the distal end of the sound tube refers to a distance suitable to measure the length of uterus and the length of cervix. The distal end of the sound tube along the specified distance may also have a form (e.g. a deformable wave-like form) and be fabricated from a material that is reformed (squeezed) in the cervix region during its insertion into the uterus. Consequently, the squeezed form indicates the length of uterus and the length of cervix. In an embodiment, an outer surface of a portion of the sound tube that is intended to be inserted into the cervical canal and the uterus, has a coating of a lubricating and/or anaesthetic product, such as gel.

Optionally, the sound tube is intended for single use and is provided sterile in a closed sales package for hygiene and safety. In an embodiment, the handle, the container for anaesthetic product, and the sound tube are in the sales package. In such case, the container for anaesthetic product is loaded in the handle and the sound tube is attached to the handle by the user prior to use. It will be appreciated that to maintain the sterility of the device components, the components of the sales package should be handled only after the sterile gloves are put on by the user. Furthermore, the loaded handle should be held upwards to prevent leakage of the anaesthetic product therefrom.

In another embodiment, the sound tube is already attached to the handle, and the handle is pre-loaded with the container for anaesthetic product (i.e. a pre-installed sound applicator), and placed in the sales package. Such a sound tube is immediately ready to use. The pre-installed sound applicator avoids manual intervention for arranging the sound tube and/or container for the anaesthetic product in the handle.

Optionally, the container for the anaesthetic product is either pre-loaded or required to be loaded in the handle for use. The container that is required to be loaded in the handle is typically closed, for example a screw-on or a snap-off closure mechanism, such as for example a removable cap, a plug, a breakable seal, and the like. In an embodiment, the container for the anaesthetic product is pre-placed, i.e. inside the handle, and needs to be opened. In another embodiment, the container for the anaesthetic product needs to be placed inside the handle, before or after opening, for example, by removing the removable cap or by breaking the seal. Thus optionally, the container for the anaesthetic product comprises a seal, and the proximal end of the sound tube is arranged to break the seal when attached to the distal end of the handle. In an example, the seal is fabricated from a similar material as used in the fabrication of the container for the anaesthetic product. However, a different material may be used . Optionally, the seal is broken by the proximal end of the sound tube when it is attached to the distal end of the handle. For example, the mouth of the container that protrudes from the handle may be closed with the seal. Thus, to enable the anaesthetic product to flow from the container into the sound tube, the seal is broken at the time of attachment of the sound tube to the handle. More optionally, the proximal end of the sound tube comprises a pricking means that pierces through the seal when it is attached to the distal end of the handle. Alternatively, the seal can be broken by hand and subsequently placed in the hand le of the sound applicator for use. It is to be understood by a person of ordinary skill in the art that the seal may be broken by bare hands or by use of cutting means, such as a pair of scissors, a blade, a knife, and so forth, without limiting the scope of the disclosure.

Optionally, the container for the anaesthetic product comprises a removable cap. In such case, the container for the anaesthetic product is required to be opened before or after placing the container in the handle of the sound applicator. The removable cap may for example be rotated in a counter-clockwise direction to open the container and subsequently placing the opened container in the handle of the sound applicator. In an example, the removable cap may protrude from the distal end of the handle. Optionally, the removable cap is also fabricated from an inert material, selected from any of an elastomeric material or plastics material. The proximal end of the sound tube is then attached to the distal end of the handle to receive the anaesthetic product from the container. Optionally, the sound applicator further comprises a removable protective cap surrounding at least the distal end of the sound tube. The removable protective cap, when present, surrounding at least the distal end of the sound tube is for hygiene and safety purpose. Additionally, when the sound tube is attached to the handle, pre-loaded with the anaesthetic product, and is ready to be used, the removable protective cap surrounding at least the d istal end of the sound tube prevents the anaesthetic product from leaking and/or drying . The removable protective cap is easily removed before the start of the sounding procedure.

In an embodiment, the sound tube may comprise a plurality of markings on its outer surface to take readings of the length of the cervical canal plus the length of the uterine cavity. In other words, the plurality of markings indicates an extent of insertion made by the sound tube until the tip of the sound tube touches the fundus of the uterus. For example, the outer surface of the sound tube has calibrated lines to read the measured length of the cervical canal plus the length of the uterine cavity.

In one embodiment, the sound applicator further comprises a flange movably arranged to surround the sound tube. Typically, the flange has a tubular cross-section. Optionally, the flange has a length Lf, wherein Lf is 5-60 % of L. Lf can be for example from 5, 10, 15, 20, 25, 30 or 40 up to 10, 15, 20, 25, 30, 40, 45, 50, 55 or 60 % of L. It will be appreciated that the length of flange, Lf, is set according to the length of the sound tube. It will be appreciated that the d istal end of the flange has a circumference that does not allow it to enter the cervical canal.

The flange can be used in two different manners, and this determines the optimal length of the flange. In one embodiment, the flange has a longer length Lf, and it is in the beginning of the insertion procedure positioned close to the proximal end of the sound tube. This kind of flange is herein called a tubular flange. During the sounding procedure, once the tip of the sound tube makes a contact to the fundus of the uterus, the tubular flange is manually pushed towards the distal end of the sound tube until a distal end of the tubular flange touches the portio of cervix. The movable tubular flange thus moves along the sound tube when pushed by the user. At this point, a position attained by the proximal end of the tubular flange on the sound tube is read with the help of markings on outer surface of the sound tube to determine the length of the uterine cavity plus the length of the cervical canal. The readings are thus taken near the proximal end of the sound tube close to the handle of the sound applicator, and the scale is reversed.

In another embodiment, the flange has a ring-like structure and thus a shorter length Lf. The flange having the ring-like structure, hereinafter referred to as a ring flange, is before use arranged closer to the distal end of the sound tube, for example below the arrangement of the plurality of openings away from the tip of the sound tube. The ring flange moves along the sound tube when the sound tube is inserted into the cervical canal, towards the proximal end of the sound tube. The movement of the ring flange is thus in a direction opposite to the direction of movement of the sound tube towards the uterus when the sound tube is inserted into the cervical canal and is advanced towards the fundus of uterus. The ring flange movement stops at a specific position on the sound tube when the tip of the sound tube makes a contact to the fundus of the uterus, as the sound tube no longer moves with respect to the cervical canal. This position attained by the ring flange on the sound tube is read with the help of markings on outer surface of the sound tube and the reading provides an accurate length of the uterine cavity plus the length of the cervical canal.

Optionally, the flange is arranged to be irreversibly locked when moved towards the distal end of the sound tube. The movement of the flange is in this embodiment thus allowed in only one direction. For example, in case of the tubular flange, the movement is towards the distal end of the sound tube to contact the portio of the cervix, where a further forward movement is prohibited, and a backward movement thereof is also prohibited due to irreversible locking . In an alternative embodiment, in case of the ring flange, the movement of the ring flange is backwards, that is towards the proximal end of the sound tube until the tip of the sound tube touches the fundus of uterus. At this point, for the ring flange, a forward movement towards the distal end of the sound tube is prohibited to prevent any inadvertent movement, and thereby preventing inaccuracies in measurement readings.

According to yet an embodiment, instead of a flange, the reformed portion of sound tube may be used to measure the anatomical depth of the uterine cavity and the length of the cervical canal, as discussed above. According to an embodiment, the process of measuring length of the uterus and length of the cervical canal (namely, operational stages of the sound applicator when in use) is as follows.

A) Prefilling stage: the handle of the sound applicator is loaded with the container prefilled with the anaesthetic product. In some embod iments, for example, the hand le may be pre-loaded with the container prefilled with the anaesthetic product (i.e. the container for the anaesthetic product is present inside the handle and is ready to use) . In such cases, load ing is not required . In case of the pre-loaded sound applicator, the sound applicator may comprise a removable protective cap surrounding at least the distal end of the sound tube. It will be appreciated that the sound tube is to be held upwards once the removable protective cap is removed from the distal end of the sound tube to prevent the anaesthetic product to leak therefrom. In case where the container is required to be loaded into the handle, the seal of the container for the aesthetic product is required to be broken by the proximal end of sound tube, or alternatively, the removable cap of the container for the anaesthetic product is removed for example by twisting the removable cap counter clockwise at 90° angle and pulling out the removable cap from the container. It will be appreciated that the opened container for the anaesthetic product is to be placed inside the handle in aseptic conditions and the proximal end of the sound tube is to be attached to the distal end of the handle with a pair of sterile gloves on. Thereafter, the sound tube is preferably lubricated for its insertion in the uterus. For example, the sound applicator is lowered down in an aseptically maintained condition to prefill the sound tube with the anaesthetic product. A few drops of the anaesthetic product flow out of the number of openings at the distal end of the sound tube and further to lubricate the tip of the sound tube. Alternatively, some anaesthetic product is transferred from the container to the sound tube using the means for discharging the anaesthetic product. The tip lubricated with the anaesthetic product facilitates smooth movement of the sound tube through the cervical canal in next stage.

B) Inserting the sound applicator: the sound tube is inserted through the vaginal opening and into the cervical canal.

C) First administration of the anaesthetic product: while the sound tube passes through the cervical canal, the means for discharging is pushed forward to discharge a first dose of the anaesthetic product from the container (or the handle) into the sound tube for delivery in the cervical canal. The anaesthetic product locally anaesthetises the cervical canal. In an example, at a position "1/2" on the markings on the handle, the container has one half of the volume of the anaesthetic product already outside the sound tube.

D) Sounding the fundus depth: while the anaesthetic product locally anaesthetizes the cervical canal, the sound tube is further inserted into the uterus so that the tip of the sound tube contacts the fundus of the uterus. E) Moving the movable flange: in an example, the proximal end of a movable flange (e.g . the tubular flange) is manually pushed forward until it contacts the portio of the cervical canal.

F) Second administration of the anaesthetic product: while the sound tube is withdrawn from uterus, and the distal end of the sound tube having the plurality of openings reaches the cervical canal, the means for discharg ing is pushed forward to discharge a second dose of the anaesthetic product from the container (or the handle) into the sound tube for further delivery in the cervical canal for the second time. G) Removal of sound tube and reading measurements: the sound tube is carefully withdrawn further and out from the subject's vag ina. The position of the tubular flange attained on the sound tube is read with the help of markings on outer surface of the sound tube to determine a combined length, i.e. the length of the uterine cavity plus the length of the cervical canal. In case of the tubular flange, the measurement of the length of the uterus is recorded at the proximal end of the tubular flange near the proximal end of the sound tube. It is to be understood that the measurement process is described by taking an example of the tubular flange. However, in case of ring flange or the without any flange, the readings taking step may be different, as described previously.

It will be appreciated that the contact of the tip of the sound tube with the fundus produces an indication mechanism for withdrawal of the sound tube from the uterine cavity. The indication mechanism for withdrawal of the sound tube from the uterine cavity is thus typically a physical pressure. Such physical pressure is felt at the hands of the user of the sound applicator, such as a trained healthcare professional. It is to be understood by a person of ordinary skill in the art that other types of indication mechanism (e.g . audio sig nal or a light signal) may be used without limiting the scope if the disclosure. According to an embod iment, the hand le of the sound applicator is closed on both sides (i.e. the upper side and the lower side). Alternatively stated, the first cover portion and the second cover portion of the handle do not have an opening to arrange the means for discharging the anaesthetic product, such as the slider. In such an embodiment, the means for discharging the anaesthetic product is a press member provided on the first cover portion (i.e. upper side of the handle). The first cover portion and the second cover portion of the handle are connected with each other as one piece with a hinge provided at the proximal end of the hand le. Thus, the first cover portion is opened and closed with respect to the second cover portion with the help of hinge. The press member lies in the interior of the handle in closed position of the handle. The press member has a hig her level of elevation at the distal end of the handle as compared to the proximal end of the handle. The level of elevation reduces in the longitud inal direction along the length of the handle from the distal end towards the proximal end of the handle. The container comprising the anaesthetic product is placed on the second cover portion. Thereafter, the press member is operable to discharge the anaesthetic product from the container only when the first cover portion having the press member integrated thereon is pressed upon the second cover portion (i.e. lower side) of the hand le thereby exerting pressure on the container to release the anaesthetic product into the sound tube.

According to an embodiment, the container for the anaesthetic product is a cylinder arranged inside the hand le and the means for discharg ing the anaesthetic product from the container is a piston movably arranged within the cylinder. The sound applicator may thus be a cylinder-piston type sound applicator (e.g . a syringe-like sound applicator) . In such an embodiment, the means for discharging the anaesthetic product is a piston (or may also be referred to as a syringe) . In such an embodiment, the anaesthetic product may be loaded directly inside the handle (i.e. there is no separate container). Alternatively, the container for the anaesthetic product may be a cylinder that conforms to the circumference of the handle and is arranged inside the handle, where the means for discharging the anaesthetic product from the container is the piston (namely, a syringe) movably arranged within the cylinder. Moreover, the means for discharging the anaesthetic product is arranged at the proximal end of the handle. Near the d istal end of the handle, a first finger-grip portion may be provided that protrudes from outer surface (a cover portion) of the handle and a second finger-grip portion protrudes from a second finger-grip portion of the handle. The first finger-grip portion and the second finger-grip portion of the handle enable a firm grip of the sound applicator. Notably, the first finger-grip portion is smaller in size than the second finger-grip portion. The handle (or the container) for the anaesthetic product is pre-loaded with the anaesthetic product and the sound tube may be attached with the handle and provided as a sing le-unit in the sales package. It will be appreciated that the sound tube may comprise a removable protective cap surrounding at least the distal end of the sound tube to prevent any leakage of the anaesthetic product. The sound applicator is ready for use once the removable protective cap is removed from at least the d istal end of the sound tube. The anaesthetic product from the handle (or the container when present) flows into the sound tube and subsequently to the cervical canal when the means (i.e. the piston) for discharging the anaesthetic product is pushed forward to d ischarge the anaesthetic product from the handle (or the container when provided) . Accord ing to another embodiment, the entire sound applicator is a cylindrical tube-like structure with varying cross-sectional diameter. In this embodiment, the means for discharging the anaesthetic product from the handle (or the container when present) is arranged at the proximal end of the handle. Furthermore, at the proximal end of the handle, a first grip portion (or a push button) for a thumb is provided for a user. The first grip portion is connected with the means for discharging the anaesthetic product from the container and drives the means for discharging towards the distal end of the handle. The first grip for the thumb is added during an injection moulding process. The distal end of the handle comprises a second grip portion that enables a grip for at least two fingers of the user. The second grip for the at least two fingers can be added during a moulding process. In an example, the first grip portion and the second grip portion are provided with a silicon seal that enable a firm grip over the handle. The container (or the interior of the handle that acts as the container) for the anaesthetic product is pre-loaded with the anaesthetic product and the sound tube is attached with the handle and provided as a single-unit in the sales package. Optionally, the sound tube is manufactured in two parts, where the proximal end of the sound tube is a stronger, moulded part having a larger diameter than the other part which is an extruded pipe with rounded tip and the plurality of openings at its distal end. In an example, the two parts may be joined by welding or other joining process, known in the art.

The sound applicator is ready for use once the optional removable protective cap is removed from the at least the distal end of the sound tube. The anaesthetic product from the handle (or the container when separately provided) flows into the sound tube and subsequently to the cervical canal when the piston is pushed forward to discharge the anaesthetic product. The pressure exerted by the thumb at the first grip portion pushes the piston to discharge the anaesthetic product from the handle (or the container) into the sound tube for further delivery of the anaesthetic product to the cervical canal.

According to an embodiment, the discharging of the anaesthetic product from the container is performed by a manual press on the surface of the container that protrudes from an opening provided in the handle. In such an embodiment, the anaesthetic product from the container flows into the sound tube and subsequently to the cervical canal when the surface of the container (a deformable tube or a pouch) is pressed in a forward direction towards the distal end of the handle. In an example, the container is pressed by a thumb of the user of the sound applicator, to discharge the anaesthetic product from the container. In such embodiment, the handle comprises a first cover portion and a second cover portion. The first cover portion is arranged opposite to the second cover portion. The first cover portion is held by the second cover portion by one or more couplings, such as a push member-slot arrangement. For example, the second cover portion may include two slots at its proximal end and at least one slot at its distal end . An interior of each slot has a structure compatible to accommodate a complimentary push member. The container for the anaesthetic product is placed on the second cover portion of the handle. Thereafter, the first cover portion is affixed with the second cover portion via the one or more couplings, such as the push member-slot arrangement. A surface portion of the container is visible form the opening provided in the first cover portion of the handle. It will be appreciated that the handle of the sound applicator, with or without the sound tube, may be required to be held upwards when loaded with the container with cap removed (or seal broken) to prevent leakage of the anaesthetic product form the container.

According to an embod iment, the sound applicator comprises a further container for an anaesthetic product. The further container refers to an additional container. For example, the sound applicator comprises a first container and a second container for an anaesthetic product. In an example, the two containers are placed one over the other. In another example, the two containers may be placed side-by-side in either direction (longitudinal or transversal d irection of the handle). Optionally, the anaesthetic product of the further container is different from the anaesthetic product of the (first) container. For example, the first container includes a first anaesthetic product, such as lidocaine, and the second container includes a second anaesthetic product, such as prilocaine. The d ischarg ing of the anaesthetic product from the two containers may be carried out simultaneously or one after another (i.e. the second container is used only once the first container is empty) .

The anaesthetic product from each container may thus flow into a common opening, such as the aforementioned flow tube, where the anaesthetic products from the two containers mix before travelling within the sound tube and further to the delivery site through the plurality of openings at the distal end of the sound tube. In an example, the flow tube may be supported and fixed to the d istal end of the handle using two support members, for example, a top support and a bottom support.

Optionally, the size of the second container is larger the first container. For example, the second container has an extended distal end in a case where the two containers are placed one over the other. Optionally, the two containers are equal in size. In an embod iment, two different sliders (or other means for d ischarg ing the anaesthetic product) may be used to squeeze out the anaesthetic products into the common opening, such as the flow tube. In other words, in such embod iment, the movement of the different sliders squeezes the anaesthetic product from the two containers. Optionally, both the sliders can be moved simultaneously. Alternatively, both the sliders can be moved alternatively. Alternatively stated, the two containers are used simultaneously or one after the other, to release corresponding anaesthetic product into the common opening where the anaesthetic products from two containers mix before administration at the delivery site, or where the anaesthetic products flow to the sound tube.

In an embodiment, the sound applicator comprises a handle and a sound tube. Moreover, the handle of the sound applicator has a proximal end and a d istal end . Furthermore, the handle comprises a container for an anaesthetic product and a means for discharging the anaesthetic product from the container. The sound tube of the sound applicator has a proximal end and a distal end, and the distance between the proximal end and the distal end defines length L of the sound tube. The proximal end of the sound tube is attached to the distal end of the handle for allowing the local anaesthetic product to enter the sound tube. The sound tube comprises a number of openings arranged along a distance D from its distal end, D being at least 10 % of L. It will be appreciated that all the contents of the sound applicator are provided sterile in a closed sales packaging, and are ready to use for a single application.

In accordance with an exemplary aspect, the present disclosure also provides a sound applicator comprising

- a container for an anaesthetic product, attachable to the connection part, and

- a sound tube

- the proximal end of the sound tube being attached to the connection part for allowing the anaesthetic product to enter the sound tube, and

According to an embodiment, the sound tube comprises means for attaching the container to its proximal end. These means can be any of those means disclosed above.

According to another embodiment, the sound applicator may also comprise a separate connection part to connect the sound tube and the container with each other. The connections part is then thus arranged between the sound tube and the container when the sound applicator is ready to use. The connection part is firmly secured to the sound tube. In an embodiment, the connection part is detachably attached to the sound tube. In a further embodiment, the connection part is fabricated from a polymeric material (e.g. a medical-grade plastic material).

According to an embodiment, the proximal end of the sound tube or the possible connection part has one support part designed to support the container. According to another embodiment, the proximal end of the sound tube or the possible connection part has two support parts, such as a first support part and a second support part, to provide a suitable grip to a user of the sound applicator when in use. The two support parts extend as projections from the proximal end of the sound tube or the possible connection part, i.e. away from the sound tube and towards the container, when the container is attached to the proximal end of the sound tube or the possible connection part and the sound applicator is ready to use. In one embodiment, the length of the first support part is equal or approximately equal to the second support part. In another embodiment, the length of the first support part is larger than length of the second support part to support the container. In yet another embodiment, the length of the first support part as well the second support part is approximately 5-50 %, preferably 5-25 % of the length of the container to provide a suitable grip to the user of the sound applicator when in use. Optionally, the length of the first support part and the second part may be, for example, from 5, 10, 15, 20, 25, 30, 35 or 40 up to 10, 15, 20, 25, 30, 40, 45, 50 % of the length of container. The container may be in any suitable form, such as in the form of a tube.

Optionally, one end of the container has a mouth that is typically closed, for example by the aforementioned removable cap, or the aforementioned breakable seal. Thus, to enable the anaesthetic product to flow from the container into the sound tube, the seal (or the removable cap) is broken at the time of attachment of the container to the proximal end of the sound tube or the possible connection part. The container is made of a material deformable by the hand of the user, as discussed previously. The anaesthetic product is discharged from the container towards the sound tube for further delivery of the anaesthetic product at the cervical canal when the surface of the container is manually pressed, optionally by a thumb of a user of the sound applicator. The aforementioned flange (such as a tubular flange or a ring flange) is preferably movably arranged to surround the sound tube. The d isclosed sound applicator is cost-effective and enables excellent tactile feed back.

The present disclosure also provides a kit for a sound applicator. The kit comprises a container, a handle, and a sound tube. The container of the kit is as described above. For example, the kit includes a container comprising an anaesthetic product. The handle of the kit is as described above. For example, the kit includes a hand le having a proximal end and a d istal end . The handle is configured to house the container of anaesthetic product. The handle also comprises means for discharging the anaesthetic product from the container. The sound tube of the kit is as described above. For example, the kit includes a sound tube having a proximal end and a d istal end, and the distance between the proximal end and the distal end defining length L of the sound tube. Moreover, the proximal end of the sound tube is attachable (or attached) to the d istal end of the handle for allowing the local anaesthetic product to enter the sound tube. Furthermore, the sound tube comprising a number of openings arranged along a d istance D from its d istal end, D being at least 10 % of L. The various embodiments and variants described above apply mutatis mutandis to the kit. EXPERIMENTAL PART

Rheology measurements

Viscosities of EM LA® Cream and Oraqix® Periodontal Gel were measured using a Kinexus Ultra+ rotational rheometer (Malvern Panalytical), to evaluate suitable viscosities for the anaesthetic product. EMLA® was measured at two different temperatures (23 °C and 37 °C), Oraqix® at seven temperatures in a range of 23 °C to 37 °C, due to the temperature- dependent viscosity.

A cone with a diameter of 40 mm and a cone angle of 0.971° was used, with a distance of 22 ± 1 pm to the lower fixture (40 mm diameter).

Approximately 0.3 ml_ formulation was used for each measurement. Measurements were performed in triplicate. The measurement program included three increasing shear rates (0.1, 1 and 5 s^_1) with 1 min measurement time per shear rate and 1 s per measurement point. Data was evaluated by rSpace software.

EMLA® showed a temperature-independent viscosity and a thixotropic behavior (reduction of viscosity with increasing shear rate).

Oraqix® showed an increase of viscosity with increasing temperature and also thixotropic behavior. The results are given below in Table 1 for EMLA® and in Table 2 for Oraqix®.

Table 1

Table 2

Thus, the anaesthetic product preferably has a viscosity, measured according to the above-described method, of about 0.1-30 Pa-s at 23 °C and shear rate 5 s^{_ 1} and about 200-1500 Pa-s at 37 °C and shear rate 0.1 s^_1.

Indeed, the viscosity, measured according to the above-describe method, can be from 0.1, 0.2, 0.5, 1, 2, 5, 10, 14, 17, or 20 up to 0.5, 1, 2, 5,

10, 14, 17, 20, 24, 25, 28 or 30 Pa-s at 23 °C and shear rate 5 s^{- 1}. The viscosity, measured according to the above-describe method, can be from 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 650, 800, 850, 900, 950, 1000, 1050, 1100 or 1150 up to 300, 350, 400, 450, 500, 550, 600, 650, 700, 650, 800, 850, 900, 950, 1000, 1050, 1100, 1150, 1200, 1250, 1300, 1350, 1400, 1450 or 1500 Pa-s at 37 °C and shear rate 0.1 s^{- 1}. DETAILED DESCRIPTION OF THE DRAWINGS

Referring to FIG. 1, there is shown a perspective view of a sound applicator 100, in accordance with an embodiment of the present disclosure. The sound applicator 100 comprises a handle 102. The handle 102 has a proximal end 104 and a distal end 106 and comprises a container 108 for an anaesthetic product, and means 110 for discharging the anaesthetic product from the container 108. Moreover, the means 110 for discharging the anaesthetic product from the container 108 is arranged in an opening 112 in the handle 102. As shown, the means 110 for discharging is a slider arranged in the opening 112 in the handle 102. There is further shown a tubular portion 114 that refers to the mouth of the container 108 protruding from the distal end 106 of the handle 102.

The sound applicator 100 also comprises a sound tube 116. The sound tube 116 has a proximal end 118 and a distal end 120. The proximal end 118 of the sound tube 116 is here attached to the distal end 120 of the handle 102 for allowing the local anaesthetic product to enter the sound tube 116. The sound tube 116 comprises a number of openings 122 arranged along a distance D from its distal end 120, D being here approximately 20 %. The proximal end 118 of the sound tube has a larger diameter than the distal end 120 of the sound tube 116. Moreover, the distal end 120 of the sound tube 116 is slightly rounded at its distal end, namely, at a tip 124. Furthermore, the tip 124 of the sound tube 116 is smoothly curved to facilitate smooth and frictionless movement of the sound tube 116 into and out of the cervical canal.

Now referring to FIG. 2, shown is a perspective view of a sound applicator 100 as shown in FIG. 1, and its sales packaging 202, in accordance with an embodiment of the present disclosure. As shown, the sound applicator 100 comprising the handle and the sound tube 116 is removed from the sales package 202 by pulling it. During the pulling, some of the anaesthetic product may flow into the sound tube 116 and through the number of openings at its distal end 120 to lubricate the tip 124.

Now referring to FIG. 3, shown is a perspective view of a sound applicator along with a flange 302, in accordance with an embodiment of the present disclosure. The flange 302 is movably arranged to surround the sound tube 116. As shown, the flange 302 is a tubular flange with a length Lf, wherein Lf is approximately 50 % of length L of the sound tube

116.

Now referring to FIGs. 4A and 4B, shown are perspective views of the handle 102 (of FIG. 1) with a removable cap 402, in accordance with an embodiment of the present disclosure. The handle 102 is pre-loaded with the container 108 for the anaesthetic product placed in the handle 102. As shown in FIG. 4A, the container 108 for the anaesthetic product comprises the removable cap 402 that is provided to cover the mouth of the container 108. As shown in FIG. 4B, the removable cap 402 is rotated in a counter-clockwise direction at a 90° angle to open the container 108. The removable cap 402 is subsequently pulled out. Moreover, the handle 102 that is loaded with the container 108 with the removable cap 402 removed is preferably held upwards to prevent leakage of the anaesthetic product therefrom. Now referring to FIG. 5, shown is a perspective view of the sound applicator of FIG. 3 with the sound tube 116 that is yet to be attached to the handle 102, in accordance with an embodiment of the present disclosure. After removal of the removable cap (similar to FIG. 4B), the sound tube 116 is to be attached to the handle 102. The proximal end 118 of the sound tube 116 is attached to the distal end 106 of the handle

102 to receive the anaesthetic product from the container 108. In this embodiment, the sound tube 116 is attached to the distal end 106 of the handle 102 by pushing the proximal end 118 of the sound tube 116 towards the handle 102 and then turning the sound tube 116 to 90° angle in a counter-clockwise direction until it locks with the handle 102 over the tubular portion 114 at the distal end 106 of the handle 102 once the removable cap (similar to FIG. 4B) of the container 108 is removed therefrom. An interior 502 of the proximal end 118 of the sound tube 116 conforms to and accommodates the tubular portion 114 (e.g., the mouth of the container 108) that protrudes at the distal end 106 of the handle 102.

Now referring to FIG. 6, shown is a perspective view of an exemplary sound applicator, with another sound tube 602, in accordance with an embodiment of the present disclosure. In FIG. 6, the sound tube 602 is similar to that of the sound tube of FIG. 1 or 3, but with a different attachment mechanism, such as an attachment mechanism 604 provided at the proximal end 118 of the sound tube 602. The sound tube 602 is in unassembled state and is to be attached to the handle 102. As shown in FIG. 6, the container 108 for the anaesthetic product comprises a seal 608, and the proximal end 118 of the sound tube 602 is arranged to break the seal 608 when attached to the distal end of the handle 102. The proximal end 118 of the sound tube 602 comprises a protrusion 606 that breaks the seal 608 of the container 108, when pushed towards the handle 102, to receive the anaesthetic product from the container 108. It will be appreciated that the sound tube 602 is attached to the handle 102 by pushing the proximal end 118 of the sound tube 602 towards the handle 102 and then turning the sound tube 602 to 90° angle in a counter-clockwise direction until it locks with the handle 102 around the tubular portion at the distal end of the handle 102.

Now referring to FIG. 7A-7E, there are shown schematic views of different arrangement of openings along a certain distance from the distal end 120 of the sound tube 116, in accordance with various embodiment of the present disclosure. In FIG. 7A-7E, the sound tube 116 comprises a number of openings 122 arranged along the sound tube 116.

In FIG. 7A, the number of openings 122 are arranged along a specified distance from its distal end 120, on smooth circular cross-section. Optionally, the specified distance from the distal end 120 on which the number of openings 122 are arranged is somewhat waved across the cross-section of the sound tube 116. FIGs 7B, 7C and 7D show exemplary arrangement of the number of openings 122 in the distal end 120 of the sound tube 116 with different density (or quantity), placement, shape and size.

Now referring to FIGs. 8A-8G, shown are perspective views of a sound applicator with the tubular flange, depicting various operational stages thereof, in accordance with an embodiment of the present disclosure.

FIG. 8A depicts a sound applicator ready to be used. As shown, the means 110 for discharging the anaesthetic product from the container 108 is at a 'start' position (i.e. the means 110 for discharging is at initial position towards the proximal end of the handle 102). In other words, the container 108 has a full volume of the anaesthetic product in the handle 102. The handle 102 is used to guide the sound tube 116 through a vaginal opening 802 towards a portio 804 of a cervical canal 806.

FIG. 8B depicts inserting the sound tube 116 into the cervical canal 806 until a mouth 808 (also known as internal os) of a uterus 810 is contacted by the tip 124 of the sound tube 116. There is further shown a fundus 812 of the uterus 810. An anaesthetic product 814 from the container 108 is discharged by the means 110 for discharging. The anaesthetic product 814 flows through the sound tube 116 into the cervical canal 806 to locally anaesthetise the cervical canal 806. As shown, the means 110 for discharging the anaesthetic product from the container 108 is at a "1/2" position (i.e. the means 110 for discharging is at middle position of the opening). In this position of the means 110 for discharging, half a dose of the anaesthetic product 814 is discharged from the container 108.

FIG. 8C depicts further insertion of the sound tube 116 into the uterus 810 after passing the tip 124 through the mouth 808 of the uterus 810. As shown, the means 110 for discharging the anaesthetic product from the container 108 is still at a "1/2" position, i.e. no more anaesthetic product has been discharged from the container 108.

FIG. 8D depicts sounding the fundus 812 by inserting the sound tube further into the uterus 810 until the tip 124 of the sound tube contacts the fundus 812 of the uterus 810. Thereafter, the flange 302 is pushed longitudinally till the flange 302 contacts the portio 804 of the cervical canal 806. The position of flange 302 now shows the combined length, i.e., a length 816 of the uterus 810 plus a length 818 of the cervical canal 806. The position of flange 302 is recorded by the markings on the outer surface of the proximal end of the sound tube. As shown, the means 110 for discharging the anaesthetic product from the container 108 is still at a "1/2" position, i.e. no more anaesthetic product from the container 108 has been discharged.

FIG. 8E depicts withdrawing the sound tube 116 out of the uterus 810. As shown, the means 110 for discharging the anaesthetic product from the container 108 is still at a "1/2" position and the flange is positioned at the marking indicative of the combined length, i.e., the length 816 of the uterus 810 plus the length 818 of the cervical canal 806.

FIG. 8F depicts a second administration of the anaesthetic product 814 in the cervical canal 806. While the sound tube 116 is withdrawn from uterus 810, and the plurality of openings of the sound tube 116 through which the anaesthetic product 814 is dischargeable reaches the cervical canal 806, the means 110 for discharging is pushed forward to discharge a second dose of the anaesthetic product 814 from the container 108 into the sound tube 116 for further delivery in the cervical canal 806. As shown, the means 110 for discharging the anaesthetic product from the container 108 is at a "0" position, i.e. full dose of the anaesthetic product from the container 108 is discharged. In "0" position, the means 110 for discharging is towards the distal end of the handle 102. FIG. 8G depicts complete withdrawal of the sound tube 116 out of the vaginal opening 802. As shown, the means 110 for discharging the anaesthetic product from the container 108 is at a "0" position, i.e. full dose of the anaesthetic product from the container 108 is discharged and the flange 302 is positioned at the marking on outer surface of the sound tube 116 that shows the combined length, i.e. the length 818 of the uterus 810 plus the length 816 of the cervical canal 806. In this case, as the flange 302 is a tubular flange, the measurement is recorded from a proximal end of the flange 302 near the proximal end 118 of the sound tube 116.

Now referring to FIGs. 9A and 9B, shown are perspective views of a sound applicator, depicting various ways of recording measurements of the length of uterus and cervical canal, in accordance with various embodiments of the present disclosure. With reference to FIG. 9A, there is shown the sound applicator with an enlarged view of a part of the sound tube 116 that bears marking of a measuring scale on its surface for reading measurements. Notably, in case of a tubular flange 302, the combined length, i.e., the length of the uterus plus the length of the cervical canal is measured from the proximal end of the tubular flange 302 near the proximal end 118 of the sound tube 116.

With reference to FIG. 9B, there is shown the sound applicator with a flange 304 having a ring-shaped structure for recording measurements. As shown, a measuring scale is provided along the length of the sound tube 116 and a ring flange 304 is movably arranged on the sound tube 116, and the position of the flange 304 is indicative of the length of the uterus plus the length of the cervical canal. Notably, in a case where the ring flange 304 is used, the length of the uterus plus the length of the cervical canal is measured near the distal end 120 of the sound tube 116. Now referring to FIGs. 10A, 10B, 11, 12A, 12B, 13A, 13B, 14A and 14B, shown are perspective views of sound applicators 1000, 1100, 1200, 1300 and 1400, in accordance with various embodiments of the present disclosure. With reference to FIG. 10A, there is shown a sound applicator 1000 with a handle 1002 and a sound tube 1004. The handle 1002 has a first cover portion 1006 and a second cover portion 1008 shown in a disengaged state. The first cover portion 1006 and the second cover portion 1008 are connected with each other as one piece with a hinge 1010 provided at a proximal end of the handle 1002. Thus, the first cover portion 1006 is opened and closed with respect to the second cover portion 1008 with the help of hinge 1010. In this case, a means 1018 for discharging is a press member provided in an inner side 1012 of the first cover portion 1006 (i.e. interior of handle 1002). A container 1020 for the anaesthetic product is placed in a recess 1014 on an inner side 1016 of the second cover portion 1008. Thereafter, the means 1018 for discharging (i.e. the press member) is operable to discharge the anaesthetic product from the container 1020 when the first cover portion 1006 is pressed upon the second cover portion 1008 of the handle 1002, and thereafter exerting pressure on the container 1020 to release the anaesthetic product into the sound tube 1004.

With reference to FIG. 10B, there is shown the sound applicator 1000 with the handle 1002 having the first cover portion 1006 and the second cover portion 1008 in an engaged state. The engaged state indicates dosed state, in which the anaesthetic product from the container can be released.

Now referring to FIG. 11, there is shown a sound applicator 1100, which is a cylinder-piston type sound applicator (e.g. a syringe-like sound applicator). The sound applicator 1100 comprises a handle 1102 and a sound tube 1104. In this case, a means 1106 for discharging the anaesthetic product is a piston (also referred to as a syringe). Near a distal end of the handle 1102, a first finger-grip portion 1110 and a second finger-grip portion 1112 are provided that protrude from an outer surface of the handle 1102. The first finger-grip portion 1110 and the second finger-grip portion 1112 enable a firm grip of the sound applicator 1100. Notably, the first finger-grip portion 1110 is smaller than the second finger-grip portion 1112. In this case, a container for the anaesthetic product is a cylinder 1108. The cylinder 1108 for the anaesthetic product is pre-loaded with the anaesthetic product and the sound tube 1104 is attached with the handle 1102 as a single-unit.

Now referring to FIG. 12A, there is shown a sound applicator 1200, which is a cylinder-piston type sound applicator (e.g. a cylindrical tube-like sound applicator with varying cross-sectional diameter). The sound applicator 1200 comprises a handle 1202 and a sound tube 1204. As shown, a means 1206 for discharging the anaesthetic product is a piston movably arranged within a cylinder 1208. An anaesthetic product is directly loaded in the cylinder 1208 (i.e. a container). The means 1206 for discharging and the cylinder 1208 together constitute the handle 1202. There is further shown a proximal end 1210 and a distal end 1212 of the handle 1202. The means 1206 for discharging is arranged at the proximal end 1210 of the handle 1202. Furthermore, at the proximal end 1210 of the handle 1202, a first grip portion 1214 (or a push button) for a thumb is provided for a user. The first grip portion 1214 is connected with the means 1206 for discharging. The distal end 1212 of the handle 1202 comprises a second grip portion 1216 that enables a grip for at least two fingers of the user. The cylinder 1208 that acts as a container for an anaesthetic product is pre-loaded with the anaesthetic product and the sound tube 1204 is attached with the handle 1202 as a single-unit. The sound tube 1204 comprises a removable protective cap 1218 (i.e. a safety cap) at a distal end of the sound tube 1204. The sound applicator 1200 is ready for use once the removable protective cap 1218 is removed.

FIG. 12B depicts a cross-sectional view of the sound applicator 1200 of FIG 12A. There is shown the cross-sectional view of the handle 1202, the sound tube 1204, the first grip portion 1214, the means 1206 for discharging, the cylinder 1208, the second grip portion 1216, and the removable protective cap 1218. Optionally, the pressure exerted by a thumb of a user at the first grip portion 1214 pushes the means 1206 for discharging to release the anaesthetic product from the cylinder 1208 into the sound tube 1204 for further delivery of the anaesthetic product at a site of action when used. The sound applicator 1200 is held in place by two fingers of the user placed firmly on the second grip portion 1216.

FIG. 13A depicts a perspective view of a sound applicator 1300, such as a blister-type sound applicator. The sound applicator 1300 comprises a handle 1302 and a sound tube 1304. The handle 1302 has a first cover portion 1306 and a second cover portion 1308. The first cover portion 1306 is arranged opposite to the second cover portion 1308. There is further shown an opening 1310 in the first cover portion 1306.

FIG. 13B depicts an exploded view of the sound applicator 1300 of FIG. 13A. In FIG. 13B, there is further shown a container 1312 for the anaesthetic product and a plurality of couplings 1314. The first cover portion 1306 is detachably attachable by the second cover portion 1308 by the plurality of couplings 1314 (such as a push member-slot arrangement, where each slot has a structure compatible to accommodate a complimentary push member). The discharging of the anaesthetic product from the container 1312 is performed by a manual press (such as by a thumb of the user) on the surface of the container 1312 that protrudes from the opening 1310 provided in the handle 1302. FIG. 14A depicts a perspective view of a sound applicator 1400, similar to the sound applicator 1300 of FIG. 13, but comprising two containers. The sound applicator 1400 comprises a handle 1402 and a sound tube 1404 equipped with a protective cap 1414. There is further shown a container 1406 and a further container 1408 for a same anaesthetic product or two different anaesthetic products. The two containers 1406 and 1408 are contained in the handle 1402. As shown, the handle 1402 comprises a first cover portion 1410 and a second cover portion 1412. The first cover portion 1410 is arranged opposite to the second cover portion 1412. The anaesthetic product is discharged from each of the two containers 1406 and 1408 when the surface(s) of the two containers, such as the container 1406 and the further container 1408, is manually pressed, optionally by a thumb of the user of the sound applicator 1400. This embodiment may also be equipped with means for discharging the anaesthetic product, for example with a slider as shown in FIG. 1 for example.

FIG. 14B depicts an exploded view of the sound applicator 1400 of FIG. 14A. In FIG. 14B, there is further shown a plurality of couplings 1416, an extended distal end 1418 of the further container 1408, a flow tube 1420, a top support member 1422A, and a bottom support member

1422B. In this case, the container 1406 is placed on the extended distal end 1418 (e.g. an extended mouth) of the further container 1408. The first cover portion 1410 is held by the second cover portion 1412 by the plurality of couplings 1416 (e.g., in a push member-slot arrangement, where each slot has a structure compatible to accommodate a complimentary push member). A surface portion of each of the two containers 1406 and 1408 is visible and pressable from openings 1424 provided in the first cover portion 1410 when the sound applicator 1400 is ready-to-use. Now referring to FIG. 15A, there is shown a perspective view of a sound applicator 1500. The sound applicator 1500 comprises a container 1502 for an anaesthetic product, a sound tube 1504, and a connection part 1506. The sound tube 1504 has a proximal end 1508 and a distal end 1510. The sound tube 1504 comprises a number of openings 1512 arranged along a distance D from the distal end 1510, D being here approximately 20 % of the length of the sound tube. Further, shown is a tubular flange 1514 movably arranged to surround the sound tube 1504. The connection part 1506 has a first support part 1516A and a second support part 1516B. The proximal end 1508 of the sound tube 1504 is attached to the connection part 1506 for allowing the anaesthetic product to enter the sound tube 1504 when in use.

Now referring to FIG. 15B, there is shown a perspective view of the sound applicator 1500 of FIG. 15A in an assembled state, i.e. when the container 1502 is attached to the connection part 1506. In the assembled state, the anaesthetic product discharges from the container 1502 towards the sound tube 1504 and is further delivered at a site of action, when the surface the container 1502 is manually pressed, optionally by a thumb of a user of the sound applicator 1500. Now referring to FIG. 16A, there is shown a perspective view of a sound applicator 1600. The sound applicator 1600 comprises a container 1602 for an anaesthetic product, a sound tube 1604, and a connection part 1606. The sound tube 1604 has a proximal end 1608 and a distal end 1610. The sound tube 1604 comprises a number of openings 1612 arranged along a distance D from the distal end 1610, D being here approximately 20 % of the length of the sound tube. There is further shown a tubular flange 1614 movably arranged to surround the sound tube 1604. The connection part 1606 has a first support part 1616A and a second support part 1616B. Notably, the length of the first support part 1616A is larger than the second support part 1616B to support the container 1602. The proximal end 1608 of the sound tube 1604 is attached to the connection part 1606 for allowing the anaesthetic product to enter the sound tube 1604 when in use.

Now referring to FIG. 16B, there is shown a perspective view of the sound applicator 1600 of FIG. 16A in an assembled state, i.e. when the container 1602 is attached to the connection part 1606. In the assembled state, the anaesthetic product discharges from the container 1602 towards the sound tube 1604 and is further delivered at a site of action, when the surface the container 1602 is manually pressed, typically by a thumb of a user of the sound applicator 1600.

Now referring to FIG. 17A, there is shown a perspective view of a sound applicator 1700. The sound applicator 1700 comprises a container 1702 for an anaesthetic product, a sound tube 1704, and a connection part 1706. The sound tube 1704 has a proximal end 1708 and a distal end 1710. The sound tube 1704 comprises a number of openings 1712 arranged along a distance D from the distal end 1710, D being here approximately 20 % of the length of the sound tube. There is further shown a tubular flange 1714 movably arranged to surround the sound tube 1704. The connection part 1706 has a first support part 1716A and a second support part 1716B. Notably, both the first support part 1716A and the second support part 1716B are elongated parts to support the container 1702 and provide a suitable grip to a user of the sound applicator 1700 when in use. The proximal end 1708 of the sound tube 1704 is attached to the connection part 1706 for allowing the anaesthetic product to enter the sound tube 1704 when in use.

Now referring to FIG. 17B, there is shown a perspective view of the sound applicator 1700 of FIG. 17A in an assembled state, i.e. when the container 1702 is attached to the connection part 1706. In the assembled state, the anaesthetic product discharges from the container 1702 towards the sound tube 1704 and is further delivered at a site of action, when the surface the container 1702 is manually pressed, typically by a thumb of a user of the sound applicator 1700.

Modifications to embodiments of the present disclosure described in the foregoing are possible without departing from the scope of the present disclosure as defined by the accompanying claims. Expressions such as "including", "comprising", "incorporating", "have", "is" used to describe and claim the present disclosure are intended to be construed in a non exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural.

Claims

1. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) comprising

- a handle (102, 1002, 1102, 1202, 1302, 1402)

- having a proximal end (104, 1210) and a distal end (106, 1212), - comprising a container (108, 1020, 1312, 1406) for an anaesthetic product (814), and

- comprising means (110, 1018, 1106, 1206) for discharging the anaesthetic product from the container,

- a sound tube (116, 602, 1004, 1104, 1204, 1304, 1404)

- having a proximal end (118) and a distal end (120), distance between the proximal end and the distal end defining length L of the sound tube,

- the sound tube comprising a number of openings (122) arranged along a distance D from its distal end, D being at least 10 % of L.

2. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to claim 1, wherein the anaesthetic product (814) is in the form selected from a gel, a thermogelling liquid and a cream.

3. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, wherein the anaesthetic product (814) comprises at least one therapeutically active agent selected from lidocaine and prilocaine.

4. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, wherein the container (108, 1020, 1312, 1406) for the anaesthetic product (814) comprises a seal (608), and the proximal end (118) of the sound tube (116, 602, 1004, 1104, 1204, 1304, 1404) is arranged to break the seal when attached to the distal end (106, 1212) of the handle (102, 1002, 1102, 1202, 1302, 1402).

5. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the claims 1-3, wherein the container (108, 1020, 1312, 1406) for the anaesthetic product (814) comprises a removable cap (402).

6. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, further comprising a flange (302, 304) movably arranged to surround the sound tube (116, 602, 1004, 1104, 1204, 1304, 1404).

7. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to claim 6, wherein the flange (302, 304) has a length Lf, wherein Lf is 5- 60 % of L.

8. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to claim 6 or 7, wherein the flange (302) is arranged to be irreversibly locked when moved towards the distal end (120) of the sound tube (116, 602, 1004, 1104, 1204, 1304, 1404).

9. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, wherein the container (108, 1020, 1312, 1406) for the anaesthetic product (814) is deformable by the means (110, 1018, 1106, 1206) for discharging the anaesthetic product from the container.

10. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to claim 9, wherein the means for discharging the anaesthetic product (814) from the container (108) is a slider arranged in an opening (112) in the handle (102).

11. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the claims 1-10, wherein the container for the anaesthetic product (814) is a cylinder (1108, 1208) arranged inside the handle (1102, 1202) and the means (1106, 1206) for d ischarging the anaesthetic product from the container is a piston movably arranged within the cylinder.

12. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, further comprising a removable protective cap (1218, 1414) surround ing at least the distal end (120) of the sound tube (116, 602, 1004, 1104, 1204, 1304, 1404) .

13. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to any of the preceding claims, comprising a further container (1408) for an anaesthetic product (814).

14. A sound applicator (100, 1000, 1100, 1200, 1300, 1400) according to claim 13, wherein the anaesthetic product (814) of the further container (1408) is different from the anaesthetic product of the container (1406) .

15. A kit for a sound applicator (100, 1000, 1100, 1200, 1300, 1400) comprising

- a container (108, 1020, 1312, 1406) comprising an anaesthetic product (814),

- a handle (102, 1002, 1102, 1202, 1302, 1402)

- having a proximal end (104, 1210) and a distal end (106, 1212),

- configured to house the container of anaesthetic product, and

- comprising means (110, 1018, 1106, 1206) for d ischarging the anaesthetic product from the container,

- a sound tube (116, 602, 1004, 1104, 1204, 1304, 1404)

- having a proximal end (118) and a d istal end (120), distance between the proximal end and the distal end defining length L of the sound tube, - the proximal end of the sound tube being attachable to the distal end of the handle for allowing the anaesthetic product to enter the sound tube, and