Deployment device for an insertable and methods of use

Abstract

A delivery device for deploying an insertable into an orifice guided by a user's digit is provided. The delivery device comprises a ring in connection with a collapsible sheath and a base portion for loading the insertable in a deployment orientation. The base portion and the collapsible sheath form a continuous surface. The base portion is moveable relative to the ring along the longitudinal axis of the collapsible sheath allowing movement of the delivery device between a first retracted state and a second extended state. A retrieval device is also provided.

Description

DEPLOYMENT DEVICE FOR AN INSERTABLE AND METHODS OF USE TECHNICAL FIELD

[0001] The present invention relates to devices for deploying an insertable into an orifice. Specifically, the invention relates to devices and methods for deploying an insertable into an orifice guided by a digit. The invention further relates to retrieval devices for retrieving an insertable from an orifice or surface. Specifically, the invention further relates to devices and methods for retrieving an insertable from an orifice guided by a user’s digit.BACKGROUND

[0002] The insertion of a variety of insertables into orifices, such as the vaginal orifice or anus, for treatment and / or diagnosis of a variety of conditions, and for a variety of other purposes is known. For example, tampons are used by females during their menstrual period to absorb menstrual fluid and the like. The use of tampons can be associated with a significant risk of infection and disease. For example, urinary tract infections have been linked to a higher risk of developing urinary tract cancers (Japanese Cancer Association ht1 s: / / onlinelibrarv. wilev.coni / doi / fall / 10. 111 / cas. 21271 or https: / / pmc.ncbi.nlm.nih.gov / articles / PMC7657239 / )). This can be precipitated by poor hygiene control during tampon insertion and / or removal.

[0003] There are essentially two modes of inserting tampons that are currently in use. The first mode is via direct digital insertion. The user inserts the tampon into the vagina with a finger(s). This can be unhygienic, uncomfortable and repulsive and, in some instances, an embarrassing procedure for a user, particularly when in public facilities. For the uninitiated, i.e., persons who have just started experiencing menstruation, the procedure can be tricky and painful. The contact between the finger and the vaginal wall may potentially result in foreign microorganisms being introduced into the vagina, together with an increased likelihood of the procedure soiling the inserter’s fingers.

[0004] There can be a lack of basic hygiene when items such as digitally insertable tampons are inserted or removed. Visible blood can remain on the fingers of a user whichcan be transferred to clothes, doors, taps and the like, whatever is touched post insertion and before washing, which is unhygienic and unpleasant for a user and also the next user.

[0005] The second mode of inserting tampons is via an applicator which is typically made from cardboard, plastic materials, or organic materials. Tampon applicators currently on the market are generally considered to provide for a more hygienic process than digital insertion. Furthermore, tampon applicators are sometimes considered to make insertion of the tampon more reliable and correct.

[0006] The problems with current tampon applicators include that they are difficult to handle (often requiring multiple movable parts) and require relatively bulky packaging. Further, tampon applicators can cause pinching of the vaginal wall. Current tampon applicators are invasive, rigid and hard and have a significant environmental impact upon disposal. Blood soiled applicators may also become a biological hazard. Given their typical length, tampon applicators are more conspicuous and more difficult to be transported and handled in a discreet manner. Furthermore, the tampon encased within many tampon applicators cannot be inspected prior to insertion which has been known to result in a user inserting an unsanitary tampon. Tampon applicators may also require some manual dexterity to operate, typically requiring use of two hands during insertion, which can be particularly challenging for new and inexperienced users, for use in cramped locations, and whilst dealing with additional clothing or accessories, and for people with physical disabilities.

[0007] Suppositories are recognised as accepted alternative formulations for pharmaceutical delivery. Vaginal suppositories are also used to administer vaginal contraceptives, pain relief and to treat various gynaecological conditions. As with tampons, digital insertion is often used to insert a suppository or pessary and carries similar biological hazard risks, and some or all of the other difficulties identified above.

[0008] WO 2006 / 086849 discloses an insertable member for digital insertion into an orifice of a human or animal, which may be used to insert a tampon. The insertion member comprises an elongate insertion body to be received within the orifice and asheath member which is detachably connected to at least a portion of the elongate insertion body. The sheath member is movable relative to the elongate insertion body between a first configuration and a second configuration such that when the sheath member is in the second configuration, the sheath member is dimensioned to receive at least part of one or more digits of a user. The sheath member contains a tampon, a suppository, tablet, or pessary and is hygienically sealed at the top end. However, this invention was found not to allow for a secure finger hold.

[0009] WO 2005 / 058218 and WO 2006 / 123132 disclose sanitary products for use by women for the absorption of menstrual fluid comprising a plug (which is the word used in both specifications to reference a tampon) and a pad joined by a sheath. In situ, when the plug is in the vagina cavity, the pad remains outside the vagina but has an absorbent layer on an inward side proximal to the plug and a liquid impermeable layer on an outward side. The sheath can comprise a tube of absorbent material for drawing excess menstrual fluid from the plug to the pad and has a layer of liquid impermeable material on its inside surface. A string is provided that extends inside the sheath from the outward end of the plug to aid removal of the product.

[0010] In use of the invention disclosed in WO 2005 / 058218 and WO 2006 / 123132, a wearer can insert a finger into the sheath from the outward side of the pad to assist with insertion of the plug into the vaginal cavity. In that configuration, a proximal portion of the plug touches the top of the user’s finger, unless in an embodiment wherein the thin film surrounding the proximal portion of the plug is substantially interposed between the tip of the user’s finger and the proximal portion of the plug. In those embodiments, the film surrounding the proximal portion of the plug is so thin that a user nevertheless feels as though she is touching the proximal end of the plug. However, the combination of the plug and pad can be bulky and obtrusive to insert and place also to remove and dispose of. Although both patent specification indicate that the pad can be moved away from the urethral opening so the pad is not soiled by urine during micturition, the practical reality is that the pad is likely to be exposed to urine irrespective.

[0011] WO 2021 / 237269 Al to Meditati Pty Ltd discloses delivery devices for deploying insertables into an orifice by a digit. The delivery devices comprise an insertable orientation means adapted to orient the insertable in a deployment orientation and digit orientation means adapted to orient a portion of at least one digit in a navigation orientation, the insertable orientation means and the digit orientation means adjoined across a partition with a partition cross-section, and the deployment orientation and the navigation orientation are arranged for digit guided deployment of the insertable into the orifice. Also disclosed is a method of deploying an insertable into an orifice guided by a digit, using the delivery device of the disclosed invention. The delivery device and method of the disclosed invention are said to be well suited to deploying tampons into the vaginal cavity. However, this invention was found to require a manufacturing approach that was intricate, bringing associated complexities for maintaining stringent quality control, and expensive, straining commercial viability.

[0012] WO 2024 / 073791 to Meditati Pty Ltd discloses a delivery device for deploying an insertable into an orifice guided by digit. The delivery device comprises: an insertable orientation means having a first longitudinal axis and a base portion, the insertable orientation means adapted to load an insertable positioned in a deployment orientation, and a skirt member extending from adjacent the insertable orientation means and having a skirt length and comprising opposing digit contacting and orifice contacting surfaces, wherein the skirt member is adapted to be movable substantially parallel to the first longitudinal axis and along the skirt length, between: an insertable surrounding configuration, wherein an orifice contacting length of the orifice contacting surface substantially faces the insertable orientation means and any loaded insertable; and a digit surrounding configuration, wherein the orifice contacting length of the orifice contacting surface substantially faces away from the insertable orientation means and any loaded insertable. Also disclosed is a method of deploying an insertable into an orifice guided by digit, using the delivery device of the disclosed invention. The delivery device and method disclosed therein are suitable for deploying tampons into the vaginal cavity. However, the delivery device disclosed therein has poor stability and control due to its flexible nature. Further, the digit orientation means has a fixed size and configurationmeaning a single manufactured device is unable to accommodate substantially varying finger sizes. Further, the overall design and configuration of the disclosed device make it difficult to clean and expose soiled surfaces after use. For example, after each use, the user must thoroughly clean all soiled surfaces of the device to prevent any residue from spilling onto surrounding or contact surfaces.

[0013] Another significant issue for tampon applicator products is an inability to dispose of a used applicator by flushing down the toilet, because current applicators are not currently manufactured using dissolvable or flushable materials. Applicators that are not made from dissolvable material, but are nonetheless flushed down a toilet, can cause significant damage and blockage in sewerage system pipes.

[0014] WO 2018 / 102155 Al to Kimberly-Clark Worldwide, Inc. discloses a flushable tampon applicator product that includes an outer tube for housing a tampon; an inner tube, at least a portion of which extends into the outer tube, wherein the outer tube includes an outer, body-contacting surface, wherein the inner tube is movable relative to the outer tube and configured to expel a tampon from the outer tube, and wherein at least one of the outer tube and the inner tube comprises a thermoplastic composition including partially-hydrolyzed polyvinyl alcohol (PVOH), polyethylene glycol (PEG), a plasticiser, and a hydrophobic polymeric component. However, such barrel tampon applicators can be awkward and obtrusive to the user, and difficult for young and inexperienced users, or people with disabilities, as it is difficult to determine as to whether placement is correct, and required two handed use.

[0015] Thus, there is a need for improved devices to deploy insertables into an orifice.

[0016] Any reference to or discussion of any document, act or item of knowledge in this specification is included solely for the purpose of providing a context for the present invention. It is not suggested or represented that any of these matters or any combination thereof, formed at the priority date, part of the common general knowledge, or was known to be relevant to attempt to solve any problem with which this specification is concerned.SUMMARY

[0017] PROBLEMS TO BE SOLVED

[0018] It is an aim and objective of the present invention to provide a deployment device, more particularly a delivery device for deploying an insertable into an orifice guided by a user’s digit. It is a further aim and objective of the present invention to provide a retrieval device, more particularly, a retrieval device for retrieving an insertable from an orifice or surface guided by a user’s digit.

[0019] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.

[0020] MEANS FOR SOLVING THE PROBLEM

[0021] In a first aspect of the present invention, there is provided a delivery device for deploying an insertable into an orifice guided by a user’s digit, the delivery device comprising:a ring in connection with a collapsible sheath; anda base portion for loading the insertable in a deployment orientation,wherein the base portion and the collapsible sheath form a continuous surface, andwherein the base portion is moveable relative to the ring along the longitudinal axis of the collapsible sheath allowing movement of the delivery device between a first retracted state and a second extended state.

[0022] Preferably, the ring is rigid.

[0023] Preferably, the base portion is moveable along the longitudinal axis of the collapsible sheath to a position beyond the ring, when the delivery device is in the second extended state.

[0024] Preferably, the base portion is adapted to fittingly engage at least a proximal portion of the insertable.

[0025] Preferably, the ring is constructed of cardboard.

[0026] Preferably, the delivery device tapers in shape such that the base portion is narrower in width than the ring.

[0027] Preferably, the collapsible sheath is translucent.

[0028] Preferably, base portion is parallel to the longitudinal axis of the collapsible sheath.

[0029] Preferably, an outer face of the ring comprises a circumferentially extending groove for accommodating a user’s finger(s).

[0030] Preferably, the base portion has a greater rigidity than the collapsible sheath.

[0031] Preferably, the base portion comprises a depression for accommodating the user’s digit.

[0032] Preferably, the base portion has a length of between about 1cm to 2cm.

[0033] Preferably, the base portion has a circumferentially extending lobed profile.

[0034] Preferably, the base portion comprises a plurality of ribs that extend in the same direction as the longitudinal axis of the collapsible sheath. Preferably, the base portion comprises between six to ten ribs.

[0035] Preferably, the collapsible sheath and the base portion are constructed of silicone.

[0036] Preferably, the delivery device further comprises a lid removably engageable with the ring. Preferably, the lid comprises a handle.

[0037] Preferably, an outer face of the collapsible sheath comprises a plurality of protrusions, when the delivery device is in the first retracted state.

[0038] Preferably, the collapsible sheath forms an angle of about 0° to about 25°.

[0039] Preferably, the collapsible sheath is in connection with an upper edge of the ring.

[0040] Preferably, the delivery device comprises a securing mechanism along the longitudinal axis of the base portion. Preferably, the securing mechanism is interposed between the base portion and the collapsible sheath along the longitudinal axis of the base portion. Preferably, the securing mechanism comprises a first indentation interposed between the collapsible sheath and the base portion on a first side of the delivery device, and a second indentation interposed between the collapsible sheath and the base portion on a second diametrically opposing side of the delivery device.

[0041] Preferably, the collapsible sheath and the base portion are flexible and resilient.

[0042] Preferably, the collapsible sheath and the base portion are constructed of at least one biodegradable material.

[0043] Preferably, the collapsible sheath and the base portion are constructed of at least dissolvable material.

[0044] Preferably, the collapsible sheath and the base portion are constructed of at least one thin wall plastic material.

[0045] Preferably, the ring has a porous structure.

[0046] In a second aspect of the present invention, there is provided a retrieval device for retrieving an insertable from an orifice or a surface guided by a user’s digit, the retrieval device comprising:a collapsible sheath in connection with a platform,wherein a first side of the platform comprises a first attachment mechanism for releasably securing a proximal end of the insertable, andwherein the platform is moveable along the longitudinal axis of the collapsible sheath allowing movement of the retrieval device between a first retracted state and a second extended state.

[0047] Preferably, the first attachment mechanism is a latching mechanism for releasably grasping and securing the proximal end of the insertable. Preferably, the first latching mechanism comprises a plurality of castellations adapted to releasably grasp the proximal end of the insertable.

[0048] Preferably, a second side of the platform comprises a release mechanism for deactivating the first latching mechanism.

[0049] Preferably, the collapsible sheath and the platform are integrally formed.

[0050] Preferably, a first end of the retrieval device comprises a digit orientation guide having an opening for receiving the user’s digit. Preferably, the opening is surrounded by a plurality of deformable teeth adapted to engage the user’s digit, when in use.

[0051] The present invention is to be interpreted with reference to at least one of the technical problems described or affiliated with the background art. The present invention aims to solve or ameliorate at least one of the technical problems and this may result in one or more advantageous effects as defined by this specification and described in detail with reference to the preferred embodiments of the present invention.BRIEF DESCRIPTION OF THE FIGURES

[0052] Figure 1 A depicts a front view of a first preferred embodiment of a delivery device, wherein the delivery device is in a first retracted state.

[0053] Figure IB depicts a front view of the delivery device of Figure 1A, wherein the delivery device is in a second extended state.

[0054] Figure 2 depicts a front perspective exploded view of the delivery device of Figure 1A, wherein the delivery device further includes a lid.

[0055] Figure 3 depicts an enlarged cross-sectional view of the delivery device of Figure 1A.

[0056] Figure 4A depicts a front view of a second preferred embodiment of a delivery device comprising a first preferred securing mechanism, wherein the delivery device is in a first retracted state.

[0057] Figure 4B depicts a front view of the second preferred embodiment of the delivery device comprising a second preferred securing mechanism, wherein the delivery device is in the first retracted state.

[0058] Figure 4C depicts a front view of the second preferred embodiment of the delivery device of Figure 4B, wherein the delivery device is in a second extended state.

[0059] Figure 5A depicts front perspective view of a first preferred embodiment of a retrieval device, wherein the retrieval device is in a first retracted state.

[0060] Figure 5B depicts a front perspective view of the retrieval device of Figure 5A, wherein the retrieval device is in a second extended state.

[0061] Figure 6A depicts an enlarged cross-sectional view of the retrieval device of Figure 5 A, wherein the retrieval device comprises a latching mechanism that is configured in a deactivated configuration.

[0062] Figure 6B depicts an enlarged cross-sectional view of the retrieval device of Figure 5 A, wherein the retrieval device comprises a latching mechanism that is configured in an activated configuration.DESCRIPTION OF THE INVENTION

[0063] Preferred embodiments of the invention will now be described with reference to the accompanying drawings and non-limiting examples.

[0064] The term “a” and “an” as used herein means one or more, of at least one.

[0065] The term “about” as used herein in relation to a numerical value means the defined numerical value plus or minus 10%.

[0066] The term "insertable" as used herein means any appropriate device capable of being inserted. More particularly, the meaning of insertable may include tampons, suppositories, IUDs, medical sample collection devices. Generally, the term insertable may include a solid medical preparation in a roughly conical or cylindrical shape designed to be inserted into the vagina or rectum.

[0067] The term "ring" as used herein means a circular or toroidal member having a central void or opening. It is to be appreciated that the ring can form a continuous circular or toroidal structure. Alternately, the ring can form a partially circular or toroidal structure having one or more truncations or breaks along its circumference or perimeter. Further, the ring may form an uneven or unsymmetrical structure.

[0068] The terms “comprise”, “comprising” and the like, as used herein, are to be construed in their inclusive, as opposed to their exclusive, sense, that is in the sense of “including, but not limited to”.

[0069] Referring to Figures 1 A to 3, there is provided a first preferred embodiment of a delivery device 1 for deploying an insertable 2 into an orifice guided by a user’s digit. The delivery device 1 comprises a ring 3 in connection with a collapsible sheath 4; and a base portion 5 for loading the insertable in a deployment orientation. The base portion 5 and the collapsible sheath 4 form a continuous surface allowing movement of the delivery device 1 between a first retracted state (as shown in Figure 1A) and a second extended state (as shown in Figure IB). Preferably, the ring is rigid.

[0070] As would be appreciated by a person skilled in the art, the orifice into which the insertable is deployed is an orifice internal to an animal, including human and non-human animals. Some embodiments of the delivery device are adapted so that the orifice internal to the animal is accessible through an external orifice of the animal. In both preferred and alternate embodiments, the orifice is an opening into the vagina, an opening into the anus, an opening into a urinary tract, an opening into a penis, a nostril, an opening into an ear, a mouth. In some alternative embodiments, the orifice is an opening into a wound or incision.

[0071] The delivery device 1 of preferred and alternative embodiments is adapted to deploy various kinds of insertables. In some embodiments, the insertable 2 is a tampon, pessary, suppository, clinical screening device, swab, cream, lubricant, pellet, tablet, capsule, supplement, implantable, medical or surgical device, therapeutic, or other insertable adapted to be of therapeutic or diagnostic benefit. In yet still further embodiments, the insertable may be an active or passive implantable or a device such as an identification data chip, a sensor for monitoring, alerting, recording or communicating data recorded from within the orifice, such as biological data, or an implantable therapeutic device for ongoing treatment or medical intervention as required.

[0072] Referring to Figure 1 A, the delivery device 1 tapers in shape such that the base portion 5 is narrower in width than the ring 3. Preferably, the delivery device 1 is a multiuse device or a reusable device. In such embodiments, whether the delivery device is packaged and / or marketed with or without an insertable, a user can wash the delivery device between uses after the insertable has been deployed. When an insertable nextneeds to be deployed, the user can insert the insertable in the delivery device, more particularly, in the base portion of the delivery device, and then continue use per the previous occasion.

[0073] The delivery device 1, and its components thereof, may be constructed of any suitable material as could be readily determined by the person skilled in the art.Preferably, materials for the manufacture of the delivery device 1 and its components thereof are selected such that they exhibit one or more of the following properties: medical grade, mouldable, invertible including invertible without split, non-porous, flexible, resilient, durable, stable at room and transport temperatures, nonallergenic, non-reactive to properties of the insertable, approved by therapeutic regulators for medical or ingested drug delivery, and having a shelf-life that exceeds 2 years, more preferably 3 years, and more preferably still, 5 years, when stored according to storage instructions, offer liquid barrier properties during use, yet at end of life be preferably totally water-soluble, or rapidly biodegradable. Yet another embodiment may include flexible woven fabric or non-woven fabrics composed of, for example, cellulose or polyester. In some preferred embodiments, another characteristic for the materials is that they do not decompose or melt when the delivery device is in direct sunlight or in a location where the temperature exceeds normal room temperature. Non-limiting examples of suitable materials may include any one or more of: a polyalkene, such as polypropylene (PP) and polyethylene (PE). The polyalkene can be high molecular weight or low molecular weight. The polyalkene can be "oxo-biodegradable" by being manufactured from a polyethylene incorporating an additive which causes degradation and then biodegradation of the polymer (polyethylene) due to oxidation; thermoplastic elastomers such as thermoplastic polyurethane or elastic rubber. The thermoplastic polyurethane can be biodegradable, where at least one component of alternating sequences of hard and soft segments is biodegradable; elastic rubber. The rubber or silicone rubber can be synthetic or natural. The rubber can be biodegradable. The rubber can be copolymerised by bioplastics such as polylactic acid, polyglycolic acid, or Poly(3-hydroxybutyrate-co-3-hydroxy valerate) or PHBY; or bioplastic elastomers verified to meet U.S. (ASTMD6400-04) and E.U. (EN 13432). The rubber can be a biodegradable rubber by crosslinking poly(hydroxyalkanoate) or polyesters.

[0074] Referring to Figures 1 A to IB, the collapsible sheath 4 has a first face 6 forming an inner surface and a second face 7 forming an outer surface, when the delivery device 1 is in the first retracted state. The first face 6 of the collapsible sheath 4 is adapted to surround the insertable 2 allowing the delivery device 1 to provide a housing for the insertable 2 during use, when the delivery device 1 is in the first retracted state. The collapsible sheath 4 forms a tapered cylindrical shape such that its radius adjacent to the base portion 5 is less than its radius adjacent to the ring 3. However, it is to be appreciated that the collapsible sheath may be configured in a variety of suitable shapes, as could be readily determined by the person skilled in the art, and that the examples shown and described herein are by way of non-limiting examples only. For example (and without limitation), the collapsible sheath 4 may be configured in shape to resemble a cone, a rectangular cone, a frustum, a tapered elliptical cylinder, a paraboloid, a truncated pyramid, or any other suitable shape thereof. Preferably, the collapsible sheath 4 forms a uniform taper such that the diameter of the collapsible sheath 4 steadily changes along its length. Preferably, the collapsible sheath 4 tapers at an angle of between about 0° to about 25°, more preferably between about 10° to about 25°. The tapered configuration allows the collapsible sheath 4 to invert such that the second face 7 folds onto itself, gradually exposing the first face 6 and the insertable 2 housed therein, while concurrently covering the second face 7 as the delivery device 1 moves from the first retracted state to the second extended state. The ability for the collapsible sheath 4 to fold over onto itself is further facilitated in some embodiments in which the collapsible sheath 4 thickness is adapted to accommodate a change in the delivery device 1 from the first retracted to the second extended state. In preferred embodiments, the collapsible sheath 4 thickness is between 0.2 mm and 1.0 mm, and in yet still further preferred embodiments, the collapsible sheath 4 thickness is between about 0.25 mm and 0.5 mm. A particularly preferred embodiment discloses the collapsible sheath 4 thickness as about 0.3 mm.

[0075] The collapsible sheath has a length greater than the length of the insertable such that the insertable is contained or housed within the collapsible sheath, when the delivery device is in the first retracted state. The collapsible sheath has a length sufficient to allow a user’s inserting digit to engage with the base portion, when the collapsible sheath is inverted and the delivery device moves from the first retracted state to the second extended state. Such configuration and length of the collapsible sheath enables the user’s inserting digit to guide, feel, and accurately place the insertable into an adjacent orifice. Preferably, the collapsible sheath 4 has a length of between about 5cm to about 20cm, more preferably between about 5cm to about 15cm, more preferably 7cm to about 10cm. Preferably, the collapsible sheath 4 has a diameter of between about 1cm to about 5 cm, more preferably between about 2cm to about 4cm. More preferably, the diameter of the collapsible sheath 4 adjacent to the base portion 5 is between about 1cm to about 3cm, more preferably between about 1 cm to about 2cm, and the diameter of the collapsible sheath 4 adjacent to the ring 3 is between about 2cm to about 5cm, more preferably between about 3 cm to about 4cm, wherein the diameter of the collapsible sheath 4 gradually tapers along its longitudinal axis. However, it is to be appreciated that the person skilled in the art may readily configure the collapsible sheath 4 to be any suitable length to sufficiently surround and house the insertable 2 during use, when the delivery device 1 is in the first retracted state. For example, in an embodiment wherein the insertable 2 is a tampon, the collapsible sheath 4 preferably has a length of between about 7cm to about 10cm. In this example, the collapsible sheath 4 is longer than a conventional tampon, allowing an interior space 8 of the delivery device 1 to house, enclose, or surround the tampon, when the delivery device 1 is in the first retracted state.

[0076] The collapsible sheath 4 is flexible and resilient, allowing the delivery device 1 to easily move between the first retracted state and the second extended state. Preferably, the collapsible sheath 4 has elastic properties enabling the collapsible sheath 4 to maintain its structural and functional integrity as the delivery device 1 moves between the first retracted state and the second extended state. The collapsible sheath 4 may be constructed of any suitable material achieving the desired flexibility, resilience, and / or elasticity, as could be readily determined by the person skilled in the art. Non-limitingexamples of suitable materials may include any one or more of: elastomers, thermoplastic elastomers, mouldable bioplastic elastomers. Further non-limiting examples include: elastic rubber. The rubber or silicone rubber can be synthetic or natural. The rubber can be biodegradable. The rubber can be copolymerised by bioplastics such as polylactic acid, polyglycolic acid, or Poly(3 -hydroxy butyrate-co-3- hydroxy valerate) or PHBY; or bioplastic elastomers verified to meet U.S. (ASTM D6400-04) and E.U. (EN 13432). The rubber can be a biodegradable rubber by crosslinking poly(hydroxyalkanoate) or polyesters; or a combination thereof. Polyurethane (PU) offers flexibility, durability, and excellent abrasion resistance. Ethylene Propylene Diene Monomer (EPDM) Rubber offers good weather, heat and ozone resistance. Nitrile Rubber (NBR): offers good oil and fuel resistance and is suitable for applications requiring chemical resistance. Natural Rubber: This product offers high resilience, elasticity, and tensile strength. Polyvinyl Chloride: This is a cost-effective and versatile material that can be formulated for flexibility. Polypropylene (PPF): offers lightweight and chemical-resistant properties and can be blended with elastomers for flexibility. Styrene-Butadiene Rubber (SBR): offering good abrasion resistance. Fluoroelastomers (FKM) offer excellent chemical and heat resistance properties and are suitable for harsh environments. Acrylonitrile Styrene Block Copolymer (ASBC) combines the properties of styrenic and acrylonitrile materials, offering good impact resistance and chemical stability. Thermoplastic Polyurethane (TPU) offers excellent elasticity, abrasion resistance, and versatility for various applications. Polyethylene: lightweight and flexible and can be modified for increased elasticity. Bio-based polymers: Materials such as polylactic acid (PLA) or polyhydroxyalkanoates (PHA) offer environmentally friendly alternatives with varying properties. Liquid Silicone Rubber (LSR): offers properties similar to silicone but with increased flexibility and processing capabilities. Flexible Polyamide (Nylon): offers good wear resistance and flexibility. Thermoplastic Copolyester (TPC): offers good flexibility and chemical resistance and is suitable for dynamic applications requiring durability. Preferably, for reusable delivery devices, the collapsible sheath 4 is constructed of silicone.

[0077] The collapsible sheath 4 is optionally translucent. Embodiments, wherein the collapsible sheath 4 is translucent, may allow for visual inspection of the contents within the delivery device 1 prior to deployment (and optionally when sealed with a lid), when the delivery device 1 is in the first retracted state (such as the insertable or residual contents following the deployment of the insertable). Thus, in such embodiments, the user can easily determine if the contained insertable is the correct item for deployment, and can monitor both the insertable and the delivery device’s condition, ensuring each remains clean and free from bacteria or residual content. For example, visibility of the interior or internal space of the delivery device allows the user to ensure that the delivery device is in proper working order and free from contamination, improving hygiene and usability.

[0078] Referring to Figure 2, the second face 7 of the collapsible sheath 4 optionally includes a plurality of protrusions 9, when the delivery device 1 is in the first retracted state. The plurality of protrusions 9 are spaced circumferentially and equidistantly along the longitudinal axis of the collapsible sheath 4, and, together, substantially extend the length of the collapsible sheath 4. The plurality of protrusions 9 may advantageously provide a gripping surface, when the delivery device 1 is in the second extended state, thereby improving user control during deployment of the insertable 2.

[0079] Still referring to Figure 2, the ring 3 is in connection with the collapsible sheath 4. An upper edge 10 of the ring 3 is in connection with and circumferentially extends around a distal end 11 of the collapsible sheath 4. An outer face 12 of the ring 3 includes a circumferentially extending groove 13 that is centrally positioned equidistant from the upper edge 10 and a lower edge 14 of the ring 3. The circumferentially extending groove 13 forms a symmetrical and circumferential concavity that is adapted to provide a gripping surface for the user. For example, the circumferentially extending groove 13 aligns with the natural shape and positioning of the user’s finger(s), providing a secure gripping surface during use of the delivery device 1. Further, the circumferentially extending groove 13 accommodates varying finger sizes, improving comfort, usability and functionality of the delivery device 1. In an alternate embodiment (not shown), theouter face 12 of the ring 3 may include a first groove and a second groove, wherein each groove is positioned at diametrically opposing regions of the ring. In this embodiment, preferably, each groove is substantially circular or oval-shaped to complement the shape of a user’s fingertip(s).

[0080] The ring 3 may be constructed of any suitable material as could be readily determined by the person skilled in the art. Non-limiting examples of suitable materials may include any one or more of: a paper-based material (such as cardboard), plastic resins (such as, and without limitation, high impact polystyrene (HIPS), polypropylene (PP), acrylonitrile butadiene styrene (ABS), high density poly ethylene (HDPE), low density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyvinyl chloride (PVC), nylon, acetal, or any combination thereof), paper-based materials (such as, and without limitation, cardboard, formed paper, molded paper, or any combination thereof), bio resins (such as, and without limitation, polylactic acid (PLA), polyvinyl alcohol (PVOH), or a combination thereof), or any combination thereof. Preferably, for a single-use delivery device, the ring 3 is constructed of at least one paper-based material, more preferably, cardboard. The ring 3 may optionally have an outer coating that substantially covers or overlays at least a portion of the ring, preferably at least the outer face of the ring. Preferably, the outer coating is soft, flexible, and / or pliable to provide a cushioned layer for the ring. Thus, the outer coating may reduce pressure and discomfort, and conform to the shape of the user’s fingers during use. The outer coating may form a smooth, textured, or tacky surface on the outer face of the ring 3.

[0081] Still referring to Figure 2, the base portion 5 and the collapsible sheath 4 form a continuous surface such that the base portion 5 is fully exposed when the delivery device 1 is in the first retracted state. The base portion 5 extends parallel to the longitudinal axis of the collapsible sheath 4 and is adapted to fittingly engage at least a proximal portion 15 of the insertable 2. Preferably, the base portion 5 has a length of between about 1cm to about 6cm, more preferably between about 1cm to about 5 cm, more preferably between about 2cm to about 4cm.

[0082] Still referring to Figure 2, a first end 16 of the base portion 5 optionally includes a depression 17 for accommodating the user’s fingertip. The depression 17 is centrally positioned on an outer surface of the base portion 5, when the delivery device is in the first retracted state. The depression 17 forms a uniform shallow concavity having smooth sloped edges. The depression 17 advantageously provides a secure anchor port by centrally guiding the user’s fingertip during use, ensuring even force distribution as the user moves the base portion 5 along the longitudinal axis of the collapsible sheath 4. The depression 17 may have any depth capable of accommodating the user’s fingertip, as could be readily determined by the person skilled in the art. In use, the user engages or contacts their fingertip with the depression 17 and pushes the base portion 5 along the longitudinal axis of the collapsible sheath 4 to a position beyond the ring 3, causing the collapsible sheath 4 to invert, which thereby facilitates movement of the delivery device 1 from the first retracted state to the second extended state.

[0083] The base portion 5 has a greater rigidity than the collapsible sheath 4 allowing the base portion 5 to maintain its structural integrity as the delivery device 1 moves between the first retracted state and the second extended state. The rigidity of the base portion 5 improves the delivery device’s 1 overall control, functionality, and usability. For example, as shown in Figure 3, the base portion 5 forms a digit orientation guide 18 for guiding the insertable 2 as the base portion 5 moves along the longitudinal axis of the collapsible sheath 4, when the delivery device 1 is in the second extended state.

[0084] The base portion 5 can be adapted to have a greater rigidity than the collapsible sheath 4 in a variety of suitable ways. For example, in the embodiment shown in Figures 2 to 3, the base portion 5 has a circumferentially extending lobed profile 19. In this embodiment, the base portion 5 includes a plurality of ribs 20 that extend in the same direction as the longitudinal axis of the collapsible sheath 4, wherein each rib 20a is spaced equidistantly and circumferentially around the perimeter of the base portion 5 to provide the circumferentially extending lobed profile 19. In an alternate embodiment (not shown), the base portion may include a plurality of ribs that extend in a direction perpendicular to the longitudinal axis of the collapsible sheath, wherein each rib is spacedequidistantly and circumferentially along the length of the base portion. In yet another alternate embodiment (not shown), the base portion may include at least one rib that continuously spirals around the perimeter of the base portion in a coiled configuration. It is to be appreciated that the base portion 5 may include any number of ribs such as, and without limitation, at least one rib, at least two ribs, at least three ribs, at least four ribs, at least five ribs, at least six ribs, at least seven ribs, at least eight ribs, at least nine ribs, at least ten ribs, at least eleven ribs, or at least twelve ribs, and that the examples shown and described herein are by way of non-limiting examples only. The rib or the plurality of ribs advantageously provides structural support for the base portion. In an alternate or preferred embodiment, the base portion 5 may optionally have a thickened cross-section relative to the collapsible sheath 4. In yet a further alternate or preferred embodiment, the base portion 5 may be constructed of or reinforced with a rigid material (such as, and without limitation, polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS), polycarbonate, nylon (polyamide), thermoplastic elastomers, paper- based materials (such as cardboard, formed paper, molded paper, or any combination thereof), or any combination thereof), or a material having greater rigidity to that of the collapsible sheath 4, as could be readily determined by the person skilled in the art. It is to be appreciated that the base portion 5 may be adapted to achieve the desired rigidity in a variety of suitable ways as could be readily determined by the person skilled in the art, and that the examples shown and described herein are by way of non-limiting examples only.

[0085] Embodiments, wherein the base portion 5 has a greater rigidity than the collapsible sheath 4, ensure the base portion 5 maintains structural integrity and resists compression and deformation as the base portion 5 moves along the longitudinal axis of the collapsible sheath 4, when the delivery device 1 moves between the first retracted state and the second extended state. Further, the aforementioned rigidity ensures the insertable is securely engageable within the base portion 5 as the delivery device 1 moves between the first retracted state and the second extended state. In turn, such configuration enhances the overall control and functionality of the delivery device 1 as the user deploys the insertable 2 into the orifice, when in use.

[0086] Referring to Figure 3, the base portion 5 is parallel to the longitudinal axis of the collapsible sheath 4. As the base portion 5 moves along the longitudinal axis of the collapsible sheath 4, a narrow gap 21 forms between an outer face 22 of the base portion 5 and the second face 7 of the collapsible sheath 4, when the delivery device 1 is in the second extended state. The depth of the narrow gap 21 corresponds to the length of the base portion 5. The narrow gap 21 is adapted to accommodate the user’s fingernail when the delivery device 1 is in the second extended state. Thus, the narrow gap 21 may advantageously protect the user’s fingernail from damage, breakage, or general discomfort during use of the delivery device 1.

[0087] Referring to Figure 2, the delivery device 1 optionally includes a lid 23 removably engageable with the ring 3 to substantially seal the interior space 8 of the delivery device 1, when the delivery device 1 is a closed configuration in the first retracted state. A first attachment ring 24 is mounted to an underside of the lid, wherein the first attachment ring 24 is removably couplable with the ring 3. The first attachment ring 24 is adapted in shape and size to fit snugly within the ring 3, facilitating a locking engagement between the lid 23 and the ring 3. For example, in the embodiment shown, the first attachment ring 24 is an O-ring being shaped and sized to be tightly engageable within the ring 3.Preferably, the O-ring is constructed of or encapsulated with an elastomeric material (such as silicone), and the ring 3 is constructed of or encapsulated with an elastomeric material (such as silicone), providing a compressible and conforming elastomeric surface interaction between the O-ring and the ring 3, when the delivery device 1 is in the closed configuration. Further, in this embodiment, the elastomeric surface interaction allows for slight deformation and ensures that the O-ring tightly and securely fittingly engages within the ring 3, forming a watertight seal.

[0088] The lid 23 optionally includes a handle (not shown). Preferably, the handle is provided by an elongate member that extends across an upper side of the lid. A first end of the elongate member is attached to a first edge of the lid and a second end of the elongate member is attached to a second diametrically opposing edge of the lid, wherein the elongate member forms a raised arch for receiving the user’s finger, when in use. Theupper side of the lid further includes an elongate depression that extends substantially the width of the lid and is positioned perpendicular to the elongate member. The elongate depression is adapted to accommodate the user’s finger, improving comfort and ease of removal of the lid. It is to be appreciated that the handle may be configured in any suitable way as could be readily determined by the person skilled in the art, and that the example described herein is by way of a non-limiting example only.

[0089] In use, the insertable 2 is positioned in the delivery device 1, when the delivery device 1 is in the first retracted state. More particularly, the proximal portion 15 of the insertable 2 is secured within the base portion 5 such that the delivery device 1 houses the insertable 2 in a deployment orientation. The user grasps the outer face 12 of the ring 3 with a first hand and places a finger from the second hand into the depression 17 of the base portion 5. Using their second hand, the user applies pressure or a push force, causing the base portion 5 to move along the longitudinal axis of the delivery device 1 to a position beyond the ring 3. Movement of the base portion 5 along the longitudinal axis causes the delivery device 1 to move between the first retracted state and the second extended state. As the delivery device 1 moves to the second extended state, the collapsible sheath 4 folds onto itself, exposing a distal end portion of the insertable 2 for delivery or deployment. As the base portion 5 moves along the longitudinal axis, the base portion 5 forms the digit orientation guide 18, allowing the user to guide and direct the exposed insertable 2 for delivery or deployment into an orifice.

[0090] Referring to Figures 4A to 4C, there is provided a second preferred embodiment of a delivery device 101 for deploying an insertable 102 into an orifice guided by a user’s digit. The delivery device 101 comprises a ring 103 in connection with a collapsible sheath 104; and a base portion 105 for loading the insertable 102 in a deployment orientation. Preferably, the ring is rigid. The base portion 105 and the collapsible sheath 104 form a continuous surface allowing movement of the delivery device 101 between a first retracted state and a second extended state. It is to be appreciated that the second preferred embodiment of the delivery device 101 described herein includes additional or modified features to those of the first preferred embodiment of the delivery device 1. Forclarity purposes, the following description of the second preferred embodiment does not repeat the description of the features consistent between the first and second preferred embodiments. However, the features consistent between embodiments (including the respective advantages) are hereby incorporated in full in the following description.

[0091] In this embodiment, the delivery device 101 is preferably a single use device, meaning that the delivery device 101 is disposed of following the deployment of the insertable into the orifice. Such embodiments are suited, for example, to embodiments in which the delivery device and insertable assembly are packaged and / or marketed as a single unit.

[0092] Referring to Figures 4A to 4C, the collapsible sheath 104 has a first face 106 forming an inner surface and a second face 107 forming an outer surface, when the delivery device 101 is in the first retracted state. As with the first preferred embodiment, the first face 106 of the collapsible sheath 104 is adapted to surround the insertable 102 allowing the delivery device 101 to provide a housing for the insertable 102 during use, when the delivery device 101 is in the first retracted state. The collapsible sheath 104 tapers in shape such that its width adjacent to the base portion 105 is less than its width adjacent to the ring 103. Preferably, the collapsible sheath 104 forms a uniform taper such that the width of the collapsible sheath 104 steadily tapers along its length.Preferably, the collapsible sheath 104 is resilient allowing the delivery device 101 to easily move between the first retracted state and the second extended state. Preferably, the collapsible sheath 104 is liquid impermeable and is designed of sufficient strength to withstand rupture during use. Preferably, the collapsible sheath 104 is inelastic.Preferably, the collapsible sheath 104 is constructed of or comprises a plastic resin, a thermoplastic, a thin-wall plastic, a biodegradable plastic, a bio resin, or a combination thereof. Non-limiting examples of suitable materials for constructing the collapsible sheath may include any one or more of: high impact polystyrene (HIPS), polypropylene, polyethylene (PE), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), high density poly ethylene (HDPE), low density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyvinyl chloride (PVC), nylon, acetal, poly lactic acid (PLA),polyvinyl alcohol (PVOH), or any combination thereof. Alternatively, the collapsible sheath may be constructed from a material suitable for use in a multi-use or reusable delivery device. Non-limiting examples of materials suitable for constructing the collapsible sheath for multi-use or reusability include silicone, thin silicone, thermoplastic elastomer (TPE), or any combination thereof.

[0093] In a preferred embodiment, the collapsible sheath may be constructed using a first laminar sheet and a second laminar sheet, joined along the perimeters of each respective laminar sheet through welding, glueing, or any suitable bonding technique well-known in the art. In this embodiment, the first laminar sheet is bonded to the second laminar sheet such that the collapsible sheath forms a substantially flat profile or planar configuration, when in an inactive or non-use state. The substantially flat profile or planar configuration allows for compact packaging and storage of the delivery device prior to use. During the use of the delivery device, the insertable is positioned within the collapsible sheath, causing the collapsible sheath to expand and transition from the flat profile into a three-dimensional, tapered shape that conforms to the contour of the insertable.

[0094] Still referring to Figures 4A to 4C, the ring 103 is in connection with the collapsible sheath 104. An outer face 112 of the ring 103 includes a circumferentially extending groove 113 that is centrally positioned equidistant from an upper edge and the lower edge of the ring, wherein the circumferentially extending groove 113 forms a symmetrical and circumferential concavity that provides a gripping surface for the user. In one example, the upper edge of the ring 103 may be in connection with and circumferentially extends around a distal end of the collapsible sheath 104. In an alternate example, a distal end portion of the collapsible sheath 104 may at least partially encircle, surround, or extend around the ring 103 to facilitate connection between the two components. In yet another example, the distal end portion of the collapsible sheath 104 may be connected to an outer surface or an inner surface of the ring 103 to facilitate connection between the two components. Any suitable technique or combination of techniques may be used to join the ring 103 and the collapsible sheath 104, as could be readily determined by the person skilled in the art. For example (and without limitation),joined by an injection over-moulding, dip moulding, heat welding, ultrasonic welding, laser welding, or heating processes, chemical bonding, mechanical clamping using clips or snap-fits, press-fit, or shrink fit, such as using heat-shrink polymer film, and any combination of these processes may be used to join the collapsible sheath 104 and the ring 103. An adhesive - such as UV LED light cured Medical Grade adhesive - may instead or additionally be used to join the components together.

[0095] Preferably, the joining technique or process creates a fixed or permanent attachment between the ring 103 and the collapsible sheath 104. In yet another (nonlimiting) example, the ring 103 and the collapsible sheath 104 may be moulded as a single or integrated unit. In an alternate embodiment, the ring may be detachably connectable to the collapsible sheath. In this embodiment, the ring is securely attachable to the collapsible sheath during the use of the delivery device (such as during movement of the delivery device between the first retracted state and the second extended state, and preparation, insertion or deployment of the insertable from the delivery device) and is detachable from the collapsible sheath after use of the delivery device (such as after deployment of the insertable). The detachability of the collapsible sheath allows for its removal and optional disposal after use. The collapsible sheath may be detachably connectable to the ring using a variety of suitable detachable connection as could be readily determined by the person skilled in the art. For example (and without limitation), the collapsible sheath may be detachably connectable to the ring using a tension or stretch fit mechanism. In this example, the collapsible sheath is constructed of an elastic or stretchable material adapted to expand over and securely attach to the ring to facilitate tight attachment between the collapsible sheath and the ring during use of the delivery device. The elasticity or stretchability of the collapsible sheath enables it to be stretched and easily detached from the ring after use.

[0096] The ring optionally has a plurality of perforations located about the circumference such that the ring forms a porous structure. In one example (not shown), the ring includes a first inner ring adapted to engage with a second inner ring. In this example, the first inner ring includes a plurality of perforations located about the circumference of the firstinner ring, wherein each perforation forms an opening on a lower edge of the first inner ring. Alternately, each perforation may form an opening on an upper edge of the first inner ring. The second inner ring includes a plurality of vertically extending undulations located about the circumference of the second inner ring. The plurality of vertically extending undulations are adapted and positioned to engage within the plurality of perforations, thereby facilitating attachment of the first inner ring with the second inner ring. Preferably, the ring further includes a first outer ring that complements the shape and size of the first and second inner rings, wherein the first outer ring is adapted to engage with and surround an outer surface of the first inner ring. Preferably, the first outer ring has a porous structure. Embodiments wherein the ring includes a first inner ring, a second inner ring, and optionally a first outer ring advantageously allow the ring to withstand compression and increase the dissolvability, compostability, and watersolubility due to its porous structure. Thus, such an embodiment may be particularly advantageous for single-use delivery devices.

[0097] Still referring to Figures 4A to 4C, the base portion 105 and the collapsible sheath 104 form a continuous surface such that the base portion 105 is fully exposed when the delivery device 1 is in the first retracted state. The base portion 105 extends parallel to the longitudinal axis of the collapsible sheath 104 and is adapted to fittingly engage or accommodate at least a proximal portion 115 of the insertable 102. Preferably, the base portion 105 has a length of between about 1 cm to about 6cm, more preferably between about 1cm to about 5 cm, more preferably between about 2cm to about 4cm.

[0098] Referring to Figure 4A, the delivery device 101 comprises a first preferred example of a securing mechanism 116A positioned along the longitudinal axis of the base portion 105, wherein the securing mechanism 116A is interposed between the base portion 105 and the collapsible sheath 104. The securing mechanism 116A includes a first indentation 117 interposed between the base portion 105 and the collapsible sheath 104 on a first side 118 of the delivery device 101, and a second indentation 119 interposed between the base portion 105 and the collapsible sheath 104 on a second diametrically opposing side 120 of the delivery device 101. Each indentation 117, 119forms a shallow depression that depresses towards the central axis of the delivery device 101 such that the first indentation 117 and the second indentation 119 cooperate to form a narrowing region 121 at a position adjacent to the base portion 105. The narrowing region 121 narrows the circumference or width of the delivery device 101 thereby providing a gripping mechanism for the insertable 102, when in use. The first indentation 117 is contactable with a first lengthwise surface region of the insertable 102, and the second indentation 119 is contactable with a second diametrically opposing lengthwise surface region of the insertable 102 to provide the gripping mechanism, enabling the base portion 105 to accommodate or receive the insertable 2 securely, during use. It is to be appreciated that the securing mechanism may include any number of indentations and that the embodiments shown and described herein are by way of non-limiting examples only. For example, the securing mechanism may include a first plurality of indentations that together substantially or partially extend the length of the base portion on a first side of the delivery device, and a second plurality of indentations that together substantially or partially extend the length of the base portion on the second diametrically opposing side of the delivery device.

[0099] In an alternate embodiment, as shown in Figure 4B, the delivery device comprises a second preferred example of a securing mechanism 116B that is formed at a junction 122 between the collapsible sheath 104 and the base portion 105. The base portion 105 is parallel to the longitudinal axis of the collapsible sheath 104. The collapsible sheath 104 extends from the base portion 105 at an angle of between about 0 degrees to about 15 degrees creating a narrowed crosswise region 123 of the delivery device 101 that extends continuously from the junction 122 along the length of the base portion 105. The narrowed crosswise region 123 provides a gripping mechanism for the insertable 102, when in use. More particularly, the narrowed crosswise region forms a narrowed circumferential region that conforms to the shape of the insertable to thereby grip the insertable, when in use. For example, a first junction 122A is contactable with a first lengthwise surface region of the insertable 102, and a second junction 122B is contactable with a second diametrically opposing lengthwise surface region of theinsertable 102 to provide the gripping mechanism for the insertable 102, as the base portion 105 tightly or securely accommodates or receives the insertable 102 during use.

[0100] The collapsible sheath preferably forms a substantially flat or planar configuration when the delivery device is not in use and is in the first retracted state. In use and when the delivery device is in the first retracted state, the insertable 102 is positioned in the delivery device lOlMore particularly, the insertable is placed within the collapsible sheath such that the proximal end 115 of the insertable 102 is positioned at the base portion 105. Placement of the insertable at the base portion of the collapsible sheath causes deformation of the narrowed crosswise region, thereby activating and enabling the securing mechanism to securely grip the proximal end of the insertable. More particularly, the securing mechanism 116 engages with or contacts the proximal end 115 of the insertable 102, securing the insertable 102 at the base portion 105 and positioning it for deployment when the delivery device 101 is in the first retracted state. The user grasps the outer face 112 of the ring 103 with a first hand and contacts a finger from the second hand with a distal end of the base portion 105. Using their second hand, the user applies pressure or a push force, causing the base portion 105 to move along the longitudinal axis of the delivery device 101 to a position beyond the ring 103. Movement of the base portion 105 along the longitudinal axis causes the delivery device 101 to move between the first retracted state and the second extended state. As the delivery device 101 moves to the second extended state, the collapsible sheath 104 folds onto itself, exposing a distal end portion of the insertable 102 for delivery or deployment into an orifice.

[0101] Referring to Figures 5A to 6B, there is provided a retrieval device 201 for retrieving an insertable from an orifice guided by a user’s digit. In an alternate or additional embodiment, the retrieval device is suitable for retrieving or collecting a sample from a surface or an orifice guided by a user’s digit. The retrieval device 201 comprises a collapsible sheath 204 in connection with a platform 205, wherein a first side 206 of the platform 205 comprises a first attachment mechanism 207 for releasably securing a proximal end of the insertable, and wherein the platform 205 is moveablealong the longitudinal axis of the collapsible sheath 204 allowing movement of the retrieval device 201 between a first retracted state (as shown in Figure 5 A) and a second extended state (as shown in Figure 5B).

[0102] The retrieval device 201 includes a first end 208 for receiving the user’s digit and a second end 209 for receiving the insertable. More particularly, and referring to Figures 5A to 5B, the retrieval device 201 includes the collapsible sheath 204, wherein the collapsible sheath 204 has a first face 210 forming an inner surface and a second face 211 forming an outer surface, when the retrieval device 201 is in the first retracted state. The collapsible sheath 204 is adapted to surround the insertable allowing the retrieval device 201 to provide a housing for the insertable during use of the retrieval device, when the retrieval device 201 is in the first retracted state. The first end of the collapsible sheath 204 defines a first opening for receiving the user’s digit, and a second opposing end of the collapsible sheath 204 defines a second opening for receiving the insertable. The collapsible sheath 204 forms a tapered cylindrical shape such that the radius of the first opening is less than the radius of the second opposing opening. However, it is to be appreciated that the collapsible sheath may be configured in a variety of suitable shapes, as could be readily determined by the person skilled in the art, and that the examples shown and described herein are by way of non-limiting examples only. For example (and without limitation), the collapsible sheath 204 may be configured in a shape to resemble a cone, a rectangular cone, a frustum, a tapered elliptical cylinder, a paraboloid, a truncated pyramid, or any other suitable shape thereof. Preferably, the collapsible sheath 204 forms a uniform taper such that the diameter of the collapsible sheath steadily changes along its length. Preferably, the collapsible sheath tapers at an angle of between about 0° to about 25°, more preferably between about 10° to about 25°. The tapered configuration allows the collapsible sheath 204 to invert such that the second face 211 folds onto itself, gradually exposing the first face 210 and the insertable housed therein, while concurrently covering the second face 211 as the retrieval device 201 moves from the first retracted state to the second extended state. Preferably, the collapsible sheath 204 has a length of between about 5cm to about 20cm, more preferably between about 5cm to about 15cm, more preferably 7cm to about 10cm. Preferably, the collapsible sheath 204has a diameter of between about 1cm to about 5 cm, more preferably between about 2cm to about 4cm. More preferably, the second end of the collapsible sheath has a diameter of between about 2cm to about 5cm, more preferably between about 3cm to about 4cm and the first end of the collapsible sheath has a diameter of between about 1cm to about 3 cm, more preferably between about 1 cm to about 2cm, wherein the diameter of the collapsible sheath 204 gradually and steadily tapers along its longitudinal axis.

[0103] The collapsible sheath 204 is flexible and resilient, allowing the retrieval device 201 to easily move between the first retracted state and the second extended state. Preferably, the collapsible sheath 204 has elastic properties enabling the collapsible sheath 204 to maintain its structural and functional integrity as the retrieval device 201 moves between the first retracted state and the second extended state. The collapsible sheath 204 may be constructed of any suitable material achieving the desired flexibility, resilience, and / or elasticity, as could be readily determined by the person skilled in the art. Non-limiting examples of suitable materials may include any one or more of:Seaweed-Based Materials; Alginates: Derived from brown seaweed, alginates can be processed into flexible films and gels with good elasticity; Seaweed Bioplastics: These materials utilize seaweed extracts to create biodegradable alternatives to traditional plastics; Potato Skin Bioplastics: Made from the starch and cellulose in potato skins, these bioplastics can be processed into flexible materials with elastic properties; Natural Rubber: Sourced from rubber trees, natural rubber maintains excellent elasticity and is biodegradable, making it a sustainable alternative to synthetic elastomers; Corn-Based Polymers; Polylactic Acid (PLA): Biodegradable and derived from corn starch, PLA can be blended with elastomers to enhance flexibility and performance; Mushroom-Based Materials; Mycelium Composites: Made from the root structure of mushrooms, these materials can be engineered for elasticity and have a low environmental impact; Coconut Coir: The fibers from coconut husks can be processed into flexible composites, offering natural elasticity and biodegradability; Cellulose-Based Materials: Derived from wood or plant fibers, cellulose can be modified to create flexible and elastic materials suitable for various applications; Hemp and Flax Composites: These plant fibers can be combined with biopolymers to develop eco-friendly materials with good elasticity and strength; SoyProtein Plastics: Made from soybeans, these plastics can be engineered to have elastic properties and are biodegradable; Natural Latex: Harvested from rubber trees, natural latex is highly elastic and biodegradable, providing a sustainable alternative to synthetic rubber materials; Algae-Based Materials; Pine Resin Composites: Derived from pine trees, resin can be used to create flexible and elastic materials through various processing techniques. Preferably, the collapsible sheath is constructed of silicone, more preferably, medical grade silicone(s). The collapsible sheath is optionally translucent.

[0104] Referring to Figures 5 A to 5B, a first ring 212 extends circumferentially around the first end of the collapsible sheath 204 to define the second opening. The first ring 212 is partially flexible and has greater rigidity than the collapsible sheath 204 such that the first ring 212 maintains its structural integrity as the retrieval device 201 moves between the first retracted state and the second extended state. The first ring 212 may achieve a greater rigidity than the collapsible sheath 204 in a variety of suitable ways, as could be readily determined by the person skilled in the art. For example, in the embodiment shown, the first ring 212 has a thickened cross-sectional profile relative to the collapsible sheath 204. Alternately, the first ring 212 may be constructed of or reinforced with a material having greater rigidity to that of the collapsible sheath 204.

[0105] The collapsible sheath 204 is in connection with the platform 205. In the embodiment shown in Figure 5B, the collapsible sheath 204 forms a first cylinder, wherein the first cylinder is in connection with a second cylinder 213 adapted to be housed within the first cylinder. The first cylinder is integrally formed with the second cylinder 213, wherein the platform 205 is provided at a first end of the second cylinder 213. The first cylinder is tapered in shape along its longitudinal axis, and the second cylinder 213 has a cylindrical shape that extends parallel to the longitudinal axis of the first cylinder. The second cylinder 213 has a diameter less than the diameter of the first cylinder to allow longitudinal movement of the second cylinder 213 within the first cylinder.

[0106] The first face 210 of the collapsible sheath 204 optionally has a textured surface. The textured surface advantageously allows the platform 205 and the secondcylinder 213 to freely move along the longitudinal axis of the retrieval device 201, facilitating smooth movement of the retrieval device 201 between the first retracted state and the second extended state. For example, the textured surface reduces the surface contact between the platform 205 and the second cylinder 213 with the first face 210 of the collapsible sheath 204, thereby reducing friction and allowing the platform 205 and the second cylinder 213 to move freely along the longitudinal axis as the retrieval device 201 moves between the first extended state and the second retracted state.

[0107] Preferably, the platform 205 area is shaped so as to substantially correspond to a shape of a cross-section of the insertable. In the embodiment shown, the first side of the platform 205 has a circular shape. The platform is integrally formed with the collapsible sheath 204 and is positioned interiorly of the collapsible sheath 204, wherein the first side of the platform 205 provides a surface for accommodating the insertable. Referring to Figure 5B, the first side of the platform 205 optionally includes a first tab 214 extending parallel to the longitudinal axis of the collapsible sheath 204 from a first side edge, and a second tab 215 extending parallel to the longitudinal axis of the collapsible sheath 204 from a second opposing side edge. The first tab 214 is adapted to contact a first surface region of the insertable and the second tab 215 is adapted to contact a second opposing surface region of the insertable, further securing and stabilising the positioning of the insertable within the retrieval device during use.

[0108] In the embodiment shown, the first attachment mechanism is a first latching mechanism. It is to be appreciated that the latching mechanism includes any attachment mechanism capable of releasably securing the proximal end of the insertable to the platform of the delivery device. In the embodiment shown in Figures 6A to 6B, the first side of the platform 205 includes the first latching mechanism 207 for grasping and securing the insertable, wherein the first latching mechanism 207 is moveable between a first activated configuration (as shown in Figure 6B) and a second deactivated configuration (as shown in Figure 6A). In the embodiment shown, the first latching mechanism 207 comprises a plurality of castellations 216 arranged circumferentially around the first side of the platform 205. In the first activated configuration, the pluralityof castellations 216 deform inwardly, causing the first side of the platform 205 to concave toward the central axis of the retrieval device 201 (as shown in Figure 6B). In this first activated configuration, the plurality of castellations 216 are adapted to grasp and secure the proximal end of the insertable 202 within a concavity formed at the first side of the platform 205. In the second deactivated configuration, the plurality of castellations 216 extend outwardly, causing the first side of the platform 205 to radially convex away from the central axis of the retrieval device 201 (as shown in Figure 6A). In this second deactivated configuration, the plurality of castellations 216 are adapted to release the proximal end of the insertable as they extend outwardly, allowing the insertable 202 to be disengaged from a convexity formed at the first side of the platform 205.

[0109] A second side of the platform 205 comprises a release mechanism 217 for deactivating the first latching mechanism 207. Preferably, the release mechanism 217 comprises a lever 218, wherein the lever 218 is operably connected to the first latching mechanism 207 to facilitate the deformation of the plurality of castellations 216 and flexure of the first side of the platform 205 between a concave and convex configuration. A first end of the lever 218 is operably connected to and centrally extends from the second side of the platform 205, and a second opposing end of the lever 218 is adapted to engage the user’s digit. The lever 218 is directionally moveable in a first direction and a second direction to activate and deactivate the first latching mechanism 207. In the first direction, the lever 218 centrally pushes towards the second side of the platform 205 generating an input push force that causes the plurality of castellations 216 to extend outwardly and the first side of the platform 205 to radially convex away from the central axis of the retrieval device 201. In the second direction, the lever 218 centrally retracts away from the second side of the platform 205 generating an input pull force that causes the plurality of castellations 216 to deform inwardly and the first side of the platform 205 to concave toward the central axis of the retrieval device 201.

[0110] Referring to Figures 5 A to 6B, the first end of the retrieval device 201 comprises a digit orientation guide 219 having an opening for receiving the user’s digit, wherein the opening is surrounded by a plurality of deformable teeth 220 for engagingthe user’s digit. In use, the user inserts a digit into the digit orientation guide 219, directionally moves the lever 218 in a first direction and applies a push force causing the collapsible sheath to move along the longitudinal axis of the retrieval device thereby facilitating movement of the collapsible sheath from the first retracted state to the second extended state. Movement of the collapsible sheath from the first retracted state to the second extended state causes the plurality of deformable teeth 220 to deform inwardly and constrict to interlock and tightly secure the user’s digit within the digit orientation guide 219. The constricting action of the plurality of deformable teeth 220 advantageously allows the retrieval device to firmly grip and accommodate a wide range of finger or digit sizes. Such configuration advantageously allows the user to securely and controllably engage the lever 218 to facilitate movement of the first latching mechanism 207 between the first activated configuration and the second deactivated configuration, and further, controllably move the platform 205 along the longitudinal axis of the collapsible sheath 204.

[0111] It is to be appreciated that the attachment mechanism may be configured as any suitable attachment mechanism that releasably secures attachment between the proximal end of the insertable and the platform of the retrieval device. For example, in an alternate embodiment (not shown), the first attachment mechanism is operably configured as a snap-lock mechanism. In this embodiment, the proximal end of the insertable includes a ball and the first side of the platform includes a socket, wherein the ball is adapted to snap-lock into the socket to secure attachment between the insertable and the platform of the delivery device. Preferably, the second side of the platform comprises a release mechanism for deactivating or disengaging the snap-lock mechanism. Preferably, the release mechanism includes a lever operably connected to the socket to facilitate deformation and flexure of the socket thereby enabling the release of the snap-lock attachment.

[0112] In yet a further alternate embodiment (not shown), the attachment mechanism is configured as a screw mechanism. In this embodiment, the proximal end of the insertable includes a first threaded rod, and the first side of the platform includes afirst threaded nut, wherein the first threaded rod is threadably engageable with the first threaded nut to facilitate releasably attachment between the insertable and the platform of the retrieval device. Preferably, the platform further includes a protrusion that extends centrally from the first side of the platform, wherein the protrusion is adapted to engage or interlock with a complementary recess extending longitudinally from the proximal end of the insertable, thereby further securing attachment of the insertable to the platform of the retrieval device.

[0113] The retrieval device optionally includes a lid removably engageable with the first ring at the second end of the collapsible sheath to substantially cover an interior space of the retrieval device, when the retrieval device is in a closed configuration in the first retracted state (not shown). Preferably, a second attachment ring is mounted to an underside of the lid, wherein the second attachment ring is removably couplable with the first ring. The second attachment ring is adapted in shape and size to fit snugly within the first ring, facilitating a locking engagement between the lid and the first ring. For example, in the embodiment shown, the second attachment ring is an O-ring being shaped and sized to be tightly engageable within the first ring. Preferably, the O-ring is constructed of or encapsulated with an elastomeric material (such as silicone), and the first ring is constructed of or encapsulated with an elastomeric material (such as silicone), providing a compressible and conforming elastomeric surface interaction between the O-ring and the first ring, when the retrieval device is in the closed configuration. Further, in this embodiment, the elastomeric surface interaction allows for slight deformation and ensures that the O-ring tightly and securely fittingly engages within the first ring, forming a watertight seal.

[0114] In use, the insertable is positioned in the retrieval device 201, when the retrieval device 201 is in the first retracted state. More particularly, the proximal end of the insertable engages with the first side of the platform 205, activating the first latching mechanism 207. As the first latching mechanism 207 moves to the first activated state, the plurality of castellations 216 deform inwardly to grasp the proximal end of the insertable, and the first side of the platform 205 concaves towards the central axis of theretrieval device 201, thereby securing the insertable within the concavity formed at the first side of the platform 205.

[0115] The user grasps the first ring 212 at the second end of the collapsible sheath 204 with a first hand and inserts a second finger from the second hand into the second opening of the collapsible sheath 204. The user contacts the second side of the platform 205 using their second finger, causing the plurality of deformable teeth 220 to deform inwardly to interlock and tightly secure the second finger within the digit orientation guide 219 formed at the first opening of the collapsible sheath 204. The user pushes against the second side of the platform 205, causing the platform 205 to move along the longitudinal axis of the collapsible sheath 204 in a first direction, causing the retrieval device 201 to move from the first retracted state to the second extended state, and thereby exposing a distal end of the insertable for sampling. In the second extended state, the user inserts the distal end of the insertable into an orifice for sampling.Alternatively, the user may contact the distal end of the insertable on a surface for sampling. After sampling, the user can optionally move the lever 218 in the first direction, causing the plurality of castellations 216 to extend outwardly and the first side of the platform 205 to radially convex away from the central axis of the retrieval device 201, thereby causing the release and disengagement of the proximal end of the insertable from the first latching mechanism 207.

[0116] Alternatively, the user can retract the retrieval device 201 by pulling against the second side of the platform 205, causing the platform 205 to move along the longitudinal axis of the collapsible sheath 204 in a second direction causing the retrieval device 201 to move from the second extended state to the first retracted state. More specialised embodiments of this retrieval device my employ additional levers, handles, pull tabs, cords or other activating mechanisms to remotely active the inner workings, particularly where more remote operation is desirable. The user can optionally engage the lid with the first ring formed at the second opening of the collapsible sheath to cover and secure the contaminated or sampled insertable within the retrieval device.

[0117] In yet a further example, the insertable may be a collection swab (such as a specimen collection swab stick). In this example, the insertable is positioned in the retrieval device, when the retrieval device is in the first retracted state. More particularly, the proximal end of the insertable engages with the first side of the platform, activating the attachment mechanism, thereby securing attachment between the insertable and the first side of the platform of the retrieval device. The user grasps the first ring at the second end of the collapsible sheath with a first hand and inserts a second finger from the second hand into the second opening of the collapsible sheath. The user contacts the second side of the platform using their second finger, causing the plurality of deformable teeth to deform inwardly to interlock and tightly secure the second finger within the digit orientation guide formed at the first opening of the collapsible sheath. The user pushes against the second side of the platform, causing the platform to move along the longitudinal axis of the collapsible sheath in a first direction, causing the retrieval device to move from the first retracted state to the second extended state, and thereby exposing a distal end of the insertable for collection of a sample (such as a swab collection). In the second extended state, the user contacts the distal end of the insertable on a surface for sample collection. After sample collection, the user can optionally retract the platform securely attached to the insertable, causing the retrieval device to move from the second extended state to the first retracted state.

[0118] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein.

[0119] The present invention and the described preferred embodiments specifically include at least one feature that is industrial applicable.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. A delivery device for deploying an insertable into an orifice guided by a user’s digit, the delivery device comprising:a ring in connection with a collapsible sheath; anda base portion for loading the insertable in a deployment orientation,wherein the base portion and the collapsible sheath form a continuous surface, andwherein the base portion is moveable relative to the ring along the longitudinal axis of the collapsible sheath allowing movement of the delivery device between a first retracted state and a second extended state.

2. The delivery device of claim 1 , wherein the ring is rigid.

3. The delivery device of claim 1 or claim 2, wherein the base portion is moveable along the longitudinal axis of the collapsible sheath to a position beyond the ring, when the delivery device is in the second extended state.

4. The delivery device of any one of the preceding claims, wherein the base portion is adapted to fittingly engage at least a proximal portion of the insertable.

5. The delivery device of any one of the preceding claims, wherein the ring is constructed of cardboard.

6. The delivery device of any one of the preceding claims, wherein the delivery device tapers in shape such that the base portion is narrower in width than the ring.

7. The delivery device of any one of the preceding claims, wherein the collapsible sheath is translucent.

8. The delivery device of any one of the preceding claims, wherein the base portion is parallel to the longitudinal axis of the collapsible sheath.

9. The delivery device of any one of the preceding claims, wherein an outer face of the ring comprises a circumferentially extending groove for accommodating a user’s finger(s).

10. The delivery device of any one of the preceding claims, wherein the base portion has a greater rigidity than the collapsible sheath.

11. The delivery device of any one of the preceding claims, wherein the base portion comprises a depression for accommodating the user’s digit.

12. The delivery device of any one of the preceding claims, wherein the base portion has a length of between about 1cm to about 2cm.

13. The delivery device of any one of the preceding claims, wherein the base portion has a circumferentially extending lobed profile.

14. The delivery device of claim 13 wherein the base portion comprises a plurality of ribs that extend in the same direction as the longitudinal axis of the collapsible sheath.

15. The delivery device of any one of the preceding claims, wherein the collapsible sheath and the base portion are constructed of silicone.

16. The delivery device of any one of the preceding claims, wherein the delivery device further comprises a lid removably engageable with the ring.

17. The delivery device of any one of the preceding claims, wherein an outer face of the collapsible sheath comprises a plurality of protrusions, when the delivery device is in the first retracted state.

18. The delivery device of any one of the preceding claims, wherein the collapsible sheath forms an angle of about 0° to about 25°.

19. The delivery device of any one of the preceding claims, wherein the collapsible sheath is in connection with an upper edge of the ring.

20. The delivery device of any one of claims 1 to 9, wherein the delivery device comprises a securing mechanism along the longitudinal axis of the base portion.

21. The delivery device of claim 20, wherein the securing mechanism is interposed between the base portion and the collapsible sheath along the longitudinal axis of the base portion.

22. The delivery device of any one of claims 21 to 22, wherein the securing mechanism comprises a first indentation interposed between the collapsible sheath and the base portion on a first side of the delivery device, and a second indentation interposed between the collapsible sheath and the base portion on a second diametrically opposing side of the delivery device.

23. The delivery device of any one of claims 1 to 9 or 20 to 22, wherein the collapsible sheath and the base portion are flexible and resilient.

24. The delivery device of claim 24, wherein the collapsible sheath and the base portion are constructed of biodegradable material.

25. The delivery device of any one of the preceding claims, wherein the ring has a porous structure.

26. A retrieval device for retrieving an insertable from an orifice or a surface guided by a user’s digit, the retrieval device comprising:a collapsible sheath in connection with a platform,wherein a first side of the platform comprises a first attachment mechanism for releasably securing a proximal end of the insertable, andwherein the platform is moveable along the longitudinal axis of the collapsible sheath allowing movement of the retrieval device between a first retracted state and a second extended state.

27. The retrieval device of claim 26, wherein the first attachment mechanism is a first latching mechanism for releasably grasping and securing the proximal end of the insertable.

28. The retrieval device of claim 27, wherein the first latching mechanism comprises a plurality of castellations adapted to releasably grasp the proximal end of the insertable.

29. The retrieval device of any one of claims 26 to 28, wherein a second side of the platform comprises a release mechanism for deactivating the first latching mechanism.

30. The retrieval device of any one of claims 28 to 29, wherein the collapsible sheath and the platform are integrally formed.

31. The retrieval device of any one of claims 27 to 30, wherein a first end of the retrieval device comprises a digit orientation guide having an opening for receiving the user’s digit.

32. The retrieval device of claim 31, wherein the opening is surrounded by a plurality of deformable teeth adapted to engage the user’s digit, when in use.

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