Deployment mechanisms for insertable objects and methods of use and manufacture thereof

Abstract

The present invention relates to a delivery device for the guided deployment of an insertable into an aperture by a finger, the delivery device comprising: an insertable orientation mechanism having a first longitudinal axis and a base, the insertable orientation mechanism being adapted to load and position the insertable in a deployed orientation; and a skirt member extending from the vicinity of the insertable object orientation mechanism and having a skirt length and including opposing finger-contacting surfaces and aperture-contacting surfaces, wherein the skirt member is adapted to be movable substantially parallel to the first longitudinal axis and along the skirt length between: a configuration surrounding an insertable object, wherein a contact aperture section of a surface of the contact aperture substantially faces the insertable object orientation mechanism and any loaded insertable object; and a configuration surrounding the finger, wherein a contact aperture section of a surface of the contact aperture substantially faces away from the insertable object orientation mechanism and any loaded insertable object. A method of deploying an insertable object into an aperture guided by a finger using a delivery device of the invention is also disclosed. The delivery devices and methods of the present invention are well suited for deployment of tampons into the vaginal cavity. A manufacturing mold adapted to mold the delivery device of the invention, a manufacturing jig for assembling the delivery device of the invention and the insertable object, and a manufacturing method for manufacturing an assembly of the delivery device and the insertable object are also disclosed.

Description

Technical Field

[0001] The present invention relates to devices for deploying an insertable into an orifice. In particular, the present invention relates to devices and methods for finger-guided deployment of an insertable into an orifice. The present invention also relates to methods of making such devices. Background Art

[0002] It is well known that various insertable objects are inserted into an orifice, such as the vaginal opening or anus, for the treatment and / or diagnosis of various diseases, as well as for various other purposes. For example, people use tampons during menstruation to absorb menstrual fluid, etc. Tampon use may be associated with a significant risk of infection and disease. For example, urinary tract infections are associated with a higher risk of urinary tract cancer (Japanese Cancer Society https: / / onlinelibrary.wiley.com / doi / full / 10.1111 / cas.12127 ). This may be caused by poor hygiene during insertion and / or removal of the tampon.

[0003] There are essentially two modes of insertion of tampons currently in use. The first mode is direct insertion by finger. The user inserts the tampon into the vagina with a finger. This can be unhygienic and invasive, and in some cases, an embarrassing process for the user, especially when in a public facility. For a novice, i.e., someone who has just started experiencing menstruation, the process can be awkward and painful. The contact between the finger and the vaginal wall can potentially result in foreign microorganisms being introduced into the vagina, while increasing the likelihood that the inserter's finger will be soiled by the process.

[0004] Basic hygiene may be lacking when inserting or removing items such as finger-insertable tampons. Visible blood may remain on the user's fingers, which may transfer to clothing, doors, faucets, anything that is touched after insertion and before washing, which is unsanitary and unpleasant for the next user.

[0005] The second current mode of inserting a tampon is through an applicator that is typically made of cardboard, plastic material, or organic material. Tampon applicators currently on the market are generally considered to provide a more sanitary process than finger insertion. In addition, tampon applicators are sometimes considered to make insertion of the tampon more reliable and correct.

[0006] Problems with current tampon applicators include that they are difficult to handle ((non-full width, full text replacement) often involving multiple movable parts) and require relatively bulky packaging. In addition, the tampon applicator may cause the vaginal wall to be squeezed. The tampon applicator is invasive and has a significant environmental impact when discarded. An applicator stained with blood is also a biohazard. Given the typical length of the tampon applicator, the tampon applicator is more conspicuous and more difficult to transport and handle in a discreet manner. In addition, the tampon enclosed in many tampon applicators cannot be inspected before insertion, which is known to result in the user inserting an unsanitary tampon. The tampon applicator may also require some manual dexterity to operate, which is particularly challenging for new and inexperienced users and people with disabilities.

[0007] Suppositories are considered an acceptable alternative formulation for drug delivery. Rectal suppositories are used to apply a variety of drugs through the rectum. Rectal suppositories are conveniently used in pediatric and geriatric populations. However, people of all ages use rectal suppositories. Vaginal suppositories and pessaries are also used to administer vaginal contraceptives, relieve pain, and treat various gynecological conditions. Pessaries come in different sizes and shapes, including, for example, donut-style pessaries, ring pessaries with supports, and Gellhorn pessaries. Pessaries can also be used to provide support for vaginal tissue that has been displaced by pelvic organ prolapse. Like tampons, finger insertion is often used to insert suppositories or pessaries, and has similar biohazard risks, as well as some or all of the other difficulties associated with finger insertion of tampons noted above.

[0008] WO2006 / 086849 discloses an insertable member for insertion into an orifice of a human or animal by means of a finger, which can be used to insert a tampon. The insertable member comprises an elongated insertion body to be received in the orifice and a sheath member detachably connected to at least a portion of the elongated insertion body. The sheath member is movable between a first configuration and a second configuration relative to the elongated insertion body, such that when the sheath member is in the second configuration, the sheath member is sized to receive at least a portion of one or more fingers of a user. The sheath member accommodates a tampon, suppository, tablet or pessary and is hygienically sealed at the top. However, it has been found that the present invention does not allow a firm grip of the fingers.

[0009] WO2005 / 058218 and WO2006 / 123132 disclose sanitary products for human use for absorbing menstrual fluid, comprising a plug (a term used in both specifications to refer to tampons) and a pad connected by a sheath. In place, when the plug is in the vaginal cavity, the pad remains outside the vagina but has an absorbent layer on the inside adjacent to the plug and a liquid-impermeable layer on the outside. The sheath may comprise a tube of absorbent material for wicking excess menstrual fluid from the plug to the pad, and the sheath has a layer of liquid-impermeable material on its inner surface. A cord extending from the outer end of the plug into the sheath is provided to assist in removing the product.

[0010] When using the invention disclosed in WO2005 / 058218 and WO2006 / 123132, the wearer can insert a finger from the outside of the pad into the sheath to help insert the plug into the vaginal cavity. In this configuration, the proximal portion of the plug contacts the user's fingertips, unless in one embodiment, the film surrounding the proximal portion of the plug is substantially between the user's fingertips and the proximal portion of the plug. In these embodiments, the film surrounding the proximal portion of the plug is so thin that the user still feels as if she is touching the proximal end of the plug. However, the combination of the plug and the pad may be cumbersome and cumbersome to insert and place as well as to remove and discard. Although both patent specifications indicate that the pad can be moved away from the urethral opening so that the pad will not be soiled by urine during urination, the reality is that the pad is likely to be exposed to urine anyway.

[0011] WO 2021 / 237269 A1 of Meditati Private Limited discloses a delivery device for deploying an insertable object into an orifice guided by a finger. The delivery device includes an insertable orientation mechanism suitable for positioning the insertable object in a deployment orientation and a finger orientation mechanism suitable for positioning a portion of at least one finger in a navigation orientation, the insertable orientation mechanism and the finger orientation mechanism are adjacent to each other by a partition having a partition cross-section, and the deployment orientation and the navigation orientation are arranged to deploy the insertable object into the orifice under finger guidance. A method for deploying an insertable object into an orifice guided by a finger using the delivery device of the disclosed invention is also disclosed. It is claimed that the delivery device and method of the disclosed invention are very suitable for deploying a tampon into the vaginal cavity. However, it was found that the present invention requires a complex manufacturing method, which brings the associated complexity of maintaining strict quality control and is expensive, limiting commercial feasibility.

[0012] Another significant problem with tampon applicator products is that the used applicator cannot be discarded by flushing it down the toilet because current applicators are not currently manufactured using dissolvable or flushable materials. Applicators that are not made of dissolvable materials but are still flushed down the toilet can cause severe damage and blockages to sewer system pipes.

[0013] WO 2018 / 102155 A1 of Kimberly-Clark Worldwide discloses a flushable tampon applicator product comprising an outer tube for accommodating a tampon; an inner tube, at least a portion of which extends into the outer tube, wherein the outer tube comprises an outer body-contacting surface, wherein the inner tube is movable relative to the outer tube and is configured to expel the tampon from the outer tube, and wherein at least one of the outer tube and the inner tube comprises a thermoplastic composition comprising partially hydrolyzed polyvinyl alcohol (PVOH), polyethylene glycol (PEG), a plasticizer, and a hydrophobic polymer component. However, such barrel-shaped tampon applicators can be awkward and cumbersome to use, and are difficult for young and inexperienced users or disabled people because it is difficult to determine whether placement is correct.

[0014] Another disadvantage of some prior art devices adapted for delivering tampons into the vaginal opening is that the use of these devices is limited to tampons, meaning that these devices cannot be appropriately configured for delivering other forms of insertables such as pessaries, suppositories, tablets, sample screening devices, or other devices that are desired to be deployed into the orifice.

[0015] There is a need for improved devices for deploying insertables into orifices that are preferably easy, comfortable, hygienic, and safe to use and that can be manufactured in large quantities at a reasonable cost.

[0016] Any reference or discussion in this specification to any document, act or item of knowledge is included solely for the purpose of providing a background to the present invention. It does not suggest or represent that any one or any combination of these matters was part of the common general knowledge as of the priority date or was known to be relevant in attempting to solve any problem addressed by the present specification. Summary of the invention

[0017] In this specification, unless otherwise specified, discussions of embodiments of the invention describing the apparatus should be understood to be embodiments applicable to all aspects of the apparatus of the invention. Even so, those skilled in the art will readily understand which embodiments may be used for which aspects of the apparatus of the invention. The same approach applies to embodiments of the invention describing aspects of the method or process of the invention or any other aspect.

[0018] According to a first aspect, the present invention provides a delivery device for finger-guided deployment of an insertable into an orifice, the delivery device comprising:

[0019] an insertable orienting mechanism having a first longitudinal axis and a base, the insertable orienting mechanism being adapted to load an insertable and position the insertable in a deployed orientation, and

[0020] a skirt member extending from adjacent the insertable object orienting mechanism and having a skirt length and including opposing finger contacting surfaces and an orifice contacting surface, wherein the skirt member is adapted to be generally parallel to the first longitudinal axis and movable along the skirt length between the following configurations:

[0021] a configuration surrounding an insertable wherein the aperture contacting segment of the aperture contacting surface generally faces the insertable orienting mechanism and any loaded insertable; and

[0022] A finger-encircling configuration wherein an aperture-contacting segment of the aperture-contacting surface faces generally away from the insertable orienting mechanism and any loaded insertable.

[0023] In some preferred embodiments, when the skirt member is moved along the length of the skirt from the configuration around the insertable object toward the configuration around the finger, the first portion of the skirt member is adapted to form a finger orientation mechanism adapted to position at least a portion of at least one finger in a navigation orientation adapted to guide deployment of the insertable object into the orifice. Preferably, the distal end of the finger orientation mechanism is located on the underside of the base of the insertable orientation mechanism.

[0024] In some preferred embodiments and some alternative embodiments, the first portion of the skirt member forming the finger orientation mechanism is adjacent to a portion of the skirt member that is interposed between the first portion of the skirt member and the underside of the insertable orientation mechanism. In some such embodiments and other embodiments, the finger orientation mechanism includes a finger engagement mechanism that is adapted to temporarily engage at least a portion of a finger adjacent to the first portion of the skirt member. According to such embodiments, the finger engagement mechanism includes a roughened or otherwise patterned section of the first portion of the skirt member. The roughened or patterned section is preferably adapted to create a substantially mating engagement between the finger orientation mechanism and at least a portion of the finger so as to releasably retain the finger in the navigation orientation.

[0025] The skirt member of the preferred embodiment extends from the vicinity of the insertable object orientation mechanism. In some embodiments, the skirt member extends from an outer section of the base of the insertable object orientation mechanism. In other embodiments, the skirt member extends from the underside of the base of the insertable object orientation mechanism. In some alternative embodiments, the skirt member extends from the distal end of the insertable object orientation mechanism.

[0026] Preferably, near the location where the skirt member extends from near the insertable object orientation mechanism, the skirt member rotates about itself so that when the skirt member is extended from a configuration surrounding the insertable object toward a configuration surrounding the finger, the first portion of the contact aperture segment can face or contact the second portion of the contact aperture segment. In a preferred embodiment, the section where the skirt member rotates about itself is the inflection point.

[0027] In preferred embodiments, movement of the skirt member along the length of the skirt from a configuration surrounding the insertable toward a configuration surrounding the finger correspondingly causes the contact finger segment of the surface of the contact finger to face or contact at least a portion of at least one finger when the finger is surrounded by the skirt member. As discussed below with respect to the method of use of the present invention, in some preferred embodiments, the underside of the base of the insertable orientation mechanism is pushed to cause the skirt member to be moved from a configuration surrounding the insertable toward a configuration surrounding the finger, so that the first portion of the skirt member forms the finger orientation mechanism. In other preferred embodiments, the distal end of the skirt member is pulled so that the skirt member moves from a configuration surrounding the insertable toward a configuration surrounding the finger, so that the first portion of the skirt member forms the finger orientation mechanism. In yet other preferred embodiments, when the underside of the base of the insertable orientation mechanism is pushed and the skirt member is pulled, so that the skirt member moves from a configuration surrounding the insertable toward a configuration surrounding the finger, the first portion of the skirt member forms the finger orientation mechanism.

[0028] Preferably, movement of the skirt member along the length of the skirt from a configuration that surrounds an insertable toward a configuration that surrounds a finger correspondingly causes a first portion of the orifice-contacting segment of the surface that contacts the aperture to face or contact a second portion of the orifice-contacting segment of the surface that contacts the aperture. In some preferred embodiments, this occurs as the skirt member moves about its inflection point. In preferred embodiments and some alternative embodiments, as the skirt member approaches the configuration that surrounds a finger, at least a portion of the orifice-contacting surface reaches a position where, when any loaded insertable is inserted into the aperture, at least a portion of the orifice-contacting surface faces or can contact the inner side of the aperture.

[0029] In some preferred embodiments, when the skirt member is in a configuration that surrounds a finger, substantially all of the finger-contacting segments of the surface that contacts the finger face or contact at least a portion of at least one finger when the finger is surrounded by the skirt member, and substantially all of the orifice-contacting segments of the surface that contacts the orifice may face or contact the inner side of the orifice.

[0030] In still other preferred embodiments, when the skirt member is in a configuration around the finger, the portion of the insertable orienting mechanism facing the aperture can face the inside of the aperture and can contact the inside of the aperture, and any loaded insertable can face the inside of the aperture and can contact the inside of the aperture. In some such embodiments, the portion of the insertable orienting mechanism facing the aperture and the loaded insertable are exposed and ready for the insertable to be deployed into the aperture.

[0031] As described above, movement of the skirt member along the length of the skirt from a configuration that surrounds a finger toward a configuration that surrounds an insertable preferably results in a first portion of the contacting aperture segment of the surface that contacts the aperture facing or contacting a second portion of the contacting aperture segment of the surface that contacts the aperture, respectively. In some preferred embodiments, the movement occurs about an inflection point. In preferred embodiments and some alternative embodiments, as the skirt member approaches closer and closer to the configuration that surrounds the insertable, at least a portion of the surface that contacts the aperture may face or may contact a portion of the insertable orienting mechanism that faces the aperture and any loaded insertable.

[0032] Preferably, movement of the skirt member along the length of the skirt from a configuration surrounding a finger toward a configuration surrounding an insertable object causes the finger contacting segment of the surface contacting the finger to move away from, or out of contact with, at least a portion of any finger located in the finger orientation mechanism.

[0033] When the skirt member is in a configuration surrounding the insertable, preferably, substantially all of the contact orifice segment of the surface that contacts the orifice faces the portion of the insertable orienting mechanism that faces the orifice and any loaded insertable for deployment, and substantially all of the contact finger segment of the surface that contacts the finger faces away from the insertable orienting mechanism and any loaded insertable for deployment.

[0034] The present invention contemplates other mechanisms for achieving movement of the skirt member along the length of the skirt member between a configuration that surrounds the insertable object and a configuration that surrounds the finger. However, the following text further describes the mechanisms described above.

[0035] According to some preferred embodiments and some alternative embodiments, after the insertable is deployed into the orifice, the skirt member can move from a configuration surrounding the finger toward, but not reaching, a configuration surrounding the insertable to be in a disposable configuration.

[0036] Preferably, when the delivery device is in a disposable configuration, at least some of the contents within any orifice that are withdrawn when the delivery device is withdrawn from the orifice can be substantially contained between overlapping portions of the surface contacting the orifice, on portions of the surface contacting the orifice that face the insertable orienting mechanism, and / or within and around the insertable orienting mechanism.

[0037] When the delivery device is in a disposable configuration, preferably, the mutually overlapping portions of the surface that contacts the orifice and the other portions of the surface that contacts the orifice substantially concentrically surround the finger orientation mechanism and the insertable object orientation mechanism. In some preferred embodiments and some alternative embodiments, the length of the substantially concentrically arranged portions is about one-eighth to about one-half of the length of the delivery device in the configuration surrounding the finger, more preferably about one-quarter to about three-eighths of the length of the delivery device in the configuration surrounding the finger. According to some embodiments, the disposable configuration is adapted to facilitate hygienic disposal of the delivery device after the insertable object is inserted into the orifice.

[0038] When used in this specification, the word "sanitary" and its grammatical variants used to describe a clean state means a clean state that is sufficiently clean for medical and paramedical applications, such as, for example, a clean state suitable for inserting a tampon. In some embodiments, the word "sanitary" may also mean a clean state that is acceptable to therapeutic goods regulatory agencies (such as the Australian Therapeutic Goods Administration and the Australian Pesticides and Veterinary Medicines Authority or the U.S. Food and Drug Administration) (the original text has no brackets, please confirm whether this form is used) to grant marketing authorization for the sale of insertables suitable for insertion into orifices in the body of animals (including human animals) without the need for prior sterilization. In this context, "sterile" and its grammatical variants refer to a sterile state, meaning the absence of bacteria and other living microorganisms.

[0039] In some preferred embodiments, the delivery device further comprises at least one lubricating mechanism along, associated with, or applied to at least a portion of the length of the skirt, the lubricating mechanism being adapted to facilitate movement of the skirt member along the length of the skirt between a configuration surrounding an insertable object and a configuration surrounding a finger. Each lubricating mechanism is preferably selected from the group consisting of: an indentation formed in the wall of the skirt member, a kink formed in the wall of the skirt member, a pattern of protrusions, a pattern of depressions, or a pattern of protrusions and depressions formed on the wall of the skirt member, and a lubricating composition applied to a portion of the surface that contacts the orifice.

[0040] Embodiments of the delivery device provide that at least one lubrication mechanism is an indentation formed in the wall of the skirt member. In some such embodiments, the indentation takes the form of a groove that facilitates movement of one portion of the surface contacting the orifice over another portion of the surface contacting the orifice. Preferably, the indentation extends substantially continuously around the skirt member. In one such preferred embodiment, the indentation includes a series of parallel ridges that are adapted to enable movement of the skirt member along the length of the skirt by substantially rotational movement of the ends of the skirt member in a helical direction along the parallel ridges. The indentation may take other forms that are adapted to facilitate movement of sections of the skirt member over each other (preferably, portions of the surface contacting the orifice move over each other).

[0041] In some embodiments of the delivery device, wherein the at least one lubricating mechanism comprises a kink formed in the wall of the skirt member, each kink is preferably located along the length of the skirt member. In some preferred embodiments, the kink is generally S-shaped in longitudinal cross-section, thereby creating concave and convex inflection points around which the skirt member can rotate. In some such embodiments, by providing additional inflection points around which the skirt member can rotate, movement of one portion of the surface contacting the orifice on another portion of the surface contacting the orifice is facilitated. In embodiments where the kink is generally S-shaped or has other longitudinal cross-sectional shapes (such as W-shaped or, for example, C-shaped), by having concave and / or convex inflection points along the length of the skirt, the introduction of a kink along the length of the skirt preferably facilitates movement of one portion of the surface contacting the orifice on another portion of the surface contacting the orifice. The kink can take other forms suitable for facilitating movement of the skirt member segments on each other (preferably, the portions of the surface contacting the orifice move on each other).

[0042] In some preferred and alternative embodiments, at least one lubricating mechanism comprises a pattern of protrusions, a pattern of depressions, or a pattern of protrusions and depressions formed on the wall of the skirt member. In a particularly preferred embodiment, the pattern is formed at an angle so that when multiple portions of the skirt length overlap each other, the protrusions and depressions on the corresponding cross-angle patterns can be substantially prevented from engaging with each other. In other embodiments, the lubricating mechanism comprises a pattern of protrusions, a pattern of depressions, or a pattern of protrusions and depressions formed on the wall of the skirt member, and the pattern is irregular. Preferred and alternative embodiments of the pattern of protrusions, depressions, or patterns of protrusions and depressions are selected from the group consisting of: a cross-hatched pattern, a spiral pattern, a honeycomb pattern, a pattern of multiple approximately hemispherical indentations in a parallel or hexagonal layout, and a corrugated pattern. The pattern can take other forms suitable for facilitating the movement of the sections of the skirt member on each other (preferably, the sections of the surface of the contact orifice move on each other).

[0043] In yet other embodiments, at least one lubricating mechanism comprises a lubricating composition applied to at least a portion of the surface contacting the orifice, the lubricating composition being selected from the group consisting of one or more of: mineral oil, synthetic oil, solid lubricant, aqueous lubricant, and biological lubricant. The lubricating composition is preferably selected based on the application of the delivery device. For example, when the delivery device is used in a medical or paramedical setting, the lubricating composition comprises one or more compositions suitable for contacting an orifice of the body.

[0044] In some preferred and alternative embodiments of the delivery device including a lubrication mechanism, two or more of the above-mentioned lubrication mechanisms or other lubrication mechanisms are employed.

[0045] The base of the insertable orienting mechanism of the preferred embodiment forms the bottom of the substantially U-shaped longitudinal cross-section of the insertable orienting mechanism. Preferably, the substantially U-shaped relative arm portions are adapted to provide support for temporarily holding the insertable in the deployment orientation. In some further preferred embodiments, when the insertable is in the insertable orienting mechanism, the proximal end of the insertable is adjacent to or more preferably contacts the upper side of the base of the insertable orienting mechanism (at the bottom of the U-shaped insertable orienting mechanism) so that the proximal end of the insertable is held within the U-shaped shape. In some embodiments, the rigidity of some or all of the U-shaped insertable orienting mechanism is greater than the rigidity of the skirt member.

[0046] As described above, in some preferred embodiments, the first portion of the skirt member forms a finger orientation mechanism. In some such embodiments and some alternative embodiments, the longitudinal cross-sections of both the insertable orientation mechanism and the portion of the skirt member that forms the finger orientation mechanism have a generally H-shaped shape. Preferably, the opposing arm portions at the bottom of the H-shaped shape are adapted to provide support for temporarily holding the finger in the navigation orientation. In some such embodiments, when a portion of at least one finger is in the finger orientation mechanism, the distal end of at least one finger is adjacent to or more preferably in contact with the underside of the base of the insertable orientation mechanism, in these embodiments, the underside of the base is formed by the top of the generally ∩-shaped component of the generally H-shaped shape. Preferably, the distal end of the finger is held within the ∩-shaped shape. In some embodiments, the stiffness of some or all of the H-shaped longitudinal cross-sections of both the insertable orientation mechanism and the portion of the skirt member that forms the finger orientation mechanism is greater than the stiffness of the remainder of the skirt member.

[0047] In some preferred and alternative embodiments employing the above-described generally U-shaped and / or generally H-shaped longitudinal cross-sections, the base of the U-shape or the horizontal portions of the H-shape are not generally straight, but rather the delivery device is formed such that these portions have a generally S-shape that lies flat or is at an acute angle to the horizontal plane, or another shape adapted to offset the opposite sides of the skirt member relative to each other at the location where the skirt member extends from the insertable orienting mechanism. In some such embodiments, the offset has the effect of one opposite side of the skirt member moving ahead of or behind the other opposite side of the skirt member as the skirt member moves between the configuration surrounding the insertable and the configuration surrounding the finger.

[0048] In some preferred embodiments, the base of the insertable orienting mechanism includes a divider adapted to separate an insertable oriented for deployment from a finger positioned in the finger orienting mechanism. In some embodiments of the delivery device, wherein the insertable orienting mechanism is substantially U-shaped in longitudinal cross-section, the divider is formed by the bottom of the U-shape. In some embodiments of the delivery device, wherein the insertable orienting mechanism and the finger orienting mechanism have substantially H-shaped in longitudinal cross-section, the divider is formed at a horizontal cross-section of the H-shape. In some preferred and alternative embodiments, the divider is formed as a portion of a substantially S-shape lying flat or at an acute angle to a horizontal plane, or another shape adapted to offset opposite sides of the skirt member relative to each other at a location where the skirt member extends from the insertable orienting mechanism.

[0049] Several preferred and alternative embodiments provide that the cross-section of the insertable orienting mechanism is generally circular or generally elliptical. However, the cross-sectional shape of the insertable orienting mechanism is generally determined by taking into account the cross-sectional shape of the insertable to be loaded into the delivery device for deployment. By way of example only, when the insertable to be loaded into the delivery device is a tampon or suppository, the cross-sectional shape of the insertable orienting mechanism will preferably be circular. By way of further example only, when the insertable to be loaded into the delivery device is a pessary (e.g., a donut-type pessary), the cross-sectional shape of the insertable orienting mechanism will preferably be elliptical or other cross-sectional shapes suitable for adapting to the cross-sectional shape of a donut-type pessary.

[0050] In a preferred embodiment, the distal end of the skirt member passes substantially concentrically through the insertable orienting mechanism when the skirt moves between the configuration surrounding the insertable object and the configuration surrounding the finger. However, in alternative embodiments, the cross-section of the insertable orienting mechanism can have different shapes, including a polygonal shape, or, for example, a square, triangle, polygon, or star shape. Some embodiments of the orienting mechanism (wherein the cross-section has sharp corners) can also be adapted to be rounded at these corners, for example, a square shape can be rounded to have a lipstick box-shaped cross-section.

[0051] Likewise, preferred embodiments of the finger orientation mechanism provide for a variety of cross-sectional shapes. However, it is particularly preferred that the finger orientation mechanism have a generally circular cross-section that is adapted to accommodate at least a portion of at least one finger. Such a generally circular cross-section is also preferred for providing generally controlled and generally uniform movement of the skirt member between a configuration surrounding the insertable object and a configuration surrounding a finger.

[0052] In some preferred and alternative embodiments of the present invention, an insertable ejection mechanism is provided that is adapted to facilitate the ejection of an insertable from the insertable orienting mechanism. Preferably, the insertable ejection mechanism is positioned adjacent to the distal portion of at least one finger in the finger orienting mechanism. More preferably, the insertable ejection mechanism is positioned at the underside of the base of the insertable orienting mechanism. In some such embodiments, the insertable ejection mechanism is generally contained within the finger orienting mechanism. Preferably, the insertable ejection mechanism is a depressible member that can be depressed by the distal portion of at least one finger in the finger orienting mechanism, thereby causing the proximal end of the insertable to eject from the insertable orienting mechanism.

[0053] In some preferred and alternative embodiments, the portion of the finger orientation mechanism adjacent to the insertable ejection mechanism can accommodate a distal segment of the nail that extends beyond the tip of the finger. Similarly, some embodiments of the delivery device (which are formed so that the horizontal portion of the above-mentioned U-shaped or H-shaped longitudinal cross-section has a generally S-shaped shape lying flat or at an acute angle to the horizontal plane, or another shape suitable for offsetting the opposite sides of the skirt member relative to each other at the position where the skirt member extends from the insertable orientation mechanism) can accommodate a distal segment of the nail that extends beyond the tip of the finger in the convex portion of such a shape.

[0054] The skirt member of some preferred embodiments also includes a mechanism for receiving the parts of the insertable object, and the mechanism for receiving the parts of the insertable object is suitable for receiving the parts of the insertable object. For the insertable object with the parts that cannot be inserted into the orifice, such an embodiment is particularly preferred. Preferably, the mechanism for receiving the parts of the insertable object is selected from the group consisting of: a skirt member width channel between an opening on the surface of the contact finger and an opening on the surface of the contact orifice, and a skirt member width slit-type channel that is open at the far end of the skirt member and extends along at least a portion of the skirt length. However, the mechanism for receiving the parts of the insertable object is preferably shaped to accommodate the parts of the insertable object. For example, the insertable object may include a retrieval line, and the retrieval line itself is not intended to be inserted into the orifice, as in the case of a tampon. In such an embodiment, the mechanism for receiving the parts of the insertable object is shaped to receive at least a portion of a retrieval line that is connected to the insertable object or is integrally formed with the insertable object.

[0055] Preferred and alternative embodiments of the skirt member have a tapered configuration along the length of the skirt, being generally widest at the distal end of the skirt member and generally narrowest at the location where the skirt member extends from the insertable object orienting mechanism. In some such embodiments, the tapered portion extends from the distal end of the skirt member to about one-eighth to about one-half of the length of the skirt member, more preferably to about one-quarter to about three-eighths of the length of the skirt member, along the length of the skirt, where the tapered portion stops. In some embodiments, whether tapered or not, the portion of the skirt member discussed in the previous sentence has a higher stiffness than the remainder of the skirt member, preferably about 0.2 times to about 2 times higher stiffness than the remainder of the skirt member, more preferably about 0.5 times to 1.5 times higher stiffness.

[0056] The tapered configuration of some embodiments is adapted to facilitate movement of the skirt member between a configuration around the insertable object and a configuration around the finger, as is a configuration that is not tapered but in which a portion of the skirt member adjacent the distal end of the skirt member is thicker than the remainder of the skirt length. In particularly preferred embodiments, the wider or thicker portion of the skirt member is adapted to be retained by a user to facilitate movement of the skirt member between a configuration around the insertable object and a configuration around the finger, and in some embodiments to a disposable configuration. In some such preferred and alternative embodiments, the widest portion of the skirt member thickness is about 0.1% to about 10.0% thicker than the remainder of the skirt member, more preferably about 1% to about 8% thicker, and more preferably about 2.5% to about 6% thicker.

[0057] The base of the insertable object orientation mechanism of some preferred embodiments also includes an insertable object engagement mechanism, which is suitable for engaging at least the proximal end of the insertable object. In some such and other embodiments, the insertable object orientation mechanism is suitable for compression engagement with at least a portion of the insertable object (such as the proximal end of the insertable object). In some such embodiments, for example, the shape and / or size of the insertable object orientation mechanism is relatively smaller than at least a portion of the insertable object, so that at least a portion of the insertable object is temporarily accommodated in the proximal portion of the insertable object orientation mechanism, because during manufacturing or by manual manipulation of the user (for example, when reloading the delivery device), the proximal end of the insertable object is forced to be inserted into the insertable object orientation mechanism.

[0058] Alternatively, the size and shape of the insertable engagement mechanism are arranged so that the proximal end of the insertable is compressively retained in the insertable orientation mechanism. According to some such embodiments, the insertable engagement mechanism includes at least one rib member. Some such embodiments disclose that engagement can occur by a plurality of rib members. In some embodiments, a plurality of rib members correspond to one or more groove members in at least the proximal portion of the insertable. Some preferred and alternative embodiments provide that the rib members are equally spaced along the periphery of the insertable orientation mechanism. As will be appreciated by those skilled in the art, in the case where the insertable is a tampon, some such embodiments are particularly preferred because some commercially available tampons are manufactured with groove members equally spaced around the periphery of the tampon.

[0059] In embodiments where the insertable has additional components such as a retrieval string (as in the case of a tampon), an orifice may be formed in the base or divider of the insertable orienting mechanism to allow passage of a retrieval string (for enabling removal of the tampon from the vaginal cavity), which typically extends from the proximal portion of a commercially available tampon. Some embodiments of the delivery device that allow passage of a retrieval string through the base or divider of the insertable orienting mechanism are adapted so that the orifice for receiving the retrieval string has a diameter or widest portion that is only minimally larger than the cross-section of the one or more retrieval strings. In some preferred embodiments, the material forming the base or divider of the insertable orienting mechanism that is punctured applies a compressive force to the one or more retrieval strings.

[0060] Because some commercially available tampons have a knot at or near the proximal end of the retrieval cord, the diameter or widest portion of the passageway through which the retrieval cord is allowed to pass can be slightly smaller than the knot. In such an embodiment, the knot can still be "squashed" or "compressed" through the passageway when the tension provided exceeds the tension required to pull the remainder of the retrieval cord through the passageway. When the tampon has been deployed into the vaginal cavity and remains in the vaginal cavity, it provides an anchor point for the distal end of the retrieval cord through which the tension can be applied, thereby facilitating the application of sufficient tension to "squash" or "compress" the knot through the passageway and / or to expand the orifice of the passageway to enable the knot to pass through the base or partition.

[0061] In particularly preferred embodiments, the passageway is configured such that the extent of fluid communication through the thickness of the base or divider of the insertable orienting mechanism is preferably minimized.In some embodiments, the aperture for receiving the retrieval wire is sized to compressively hold the retrieval wire against movement without user intervention.

[0062] In some such preferred embodiments, the distal end of the retrieval string is connected to the proximal end of the tampon, or is interwoven with other materials forming the tampon, so that even when the tampon has been deployed into the vaginal cavity, at least the distal end of the retrieval string remains with the proximal end of the tampon. When in place, the proximal end of the retrieval string hangs outside the vagina. When needed, the user can grasp the distal end of the retrieval string and pull the retrieval string to remove the tampon from the vagina.

[0063] The finger orientation mechanism of the preferred embodiment also includes a portion adapted to snugly retain a portion of at least one finger in a navigation orientation. Preferred and alternative embodiments of the present invention disclose that the finger orientation mechanism also includes a distal portion adjacent to the base or divider of the insertable orientation mechanism. In some such embodiments, the distal portion of the finger orientation mechanism is adapted to snugly retain a proportion of the distal phalanges of a user's finger. In other embodiments, the distal portion of the finger orientation mechanism may accommodate a segment of one or more phalanges of a finger.

[0064] It is particularly preferred that the distal portion of the finger orientation mechanism accommodates at least a portion of one finger. However, some alternative embodiments of the distal portion of the finger orientation mechanism are also adapted to accommodate at least a portion of more than one finger (e.g., two fingers or three fingers). Although this is not typical, in some alternative embodiments, the distal portion of the finger orientation mechanism is adapted to accommodate four fingers or five fingers. In some alternative embodiments, the finger is a finger-shaped member in the form of a finger. Some such alternative embodiments provide that the finger-shaped member is a rod-shaped device or other similarly shaped device that can be manipulated by a manual mechanical or electromechanical mechanism, and can include a robotically controlled finger-shaped member.

[0065] Preferred and some alternative embodiments provide a navigation orientation such that in the navigation orientation, a portion of at least one finger is oriented to apply at least one directional force to the insertable in the deployment orientation to deploy the insertable through the physical structure defining the orifice. In some such embodiments, the deployment orientation has a longitudinal axis and the navigation orientation has a longitudinal axis, and the deployment orientation and the navigation orientation are arranged so that the deployment orientation longitudinal axis and the navigation orientation longitudinal axis intersect in a manner that is substantially parallel to each other, substantially aligned with each other, or at an angle suitable to facilitate deployment of the insertable into the orifice.

[0066] In some embodiments, the selected alignment of the longitudinal axis of the navigation orientation and the longitudinal axis of the deployment orientation is further adapted to account for at least one method being spatially accessible by a hand, with at least one finger extending from the hand to the physical structure defining the orifice.

[0067] According to some preferred and alternative embodiments, the spatially accessible method is a method that takes into account anthropometric measurements that enables a user to insert the insertable with ergonomic efficiency, meaning starting from an ergonomic position and in a time frame that is roughly equivalent to the normal time frame for inserting the insertable into an orifice without the device. In some such embodiments, the expression "ergonomic" refers to a method that does not cause the user to overextend the normal range of rotation of their shoulder joint and / or enables the insertable to be deployed into the orifice with minimal discomfort. Another advantage of the present invention is that it is particularly suitable for an ergonomic method that enables the insertable to be deployed into the orifice with minimal discomfort, which is prominent in cases where the insertable is a tampon and the person may experience high sensitivity in and around the vagina (particularly related to insertion, such as vaginismus).

[0068] In some embodiments, the methods encompassed by "ergonomic" are methods that a user may employ when self-applying the device to insert a tampon. For example, a user may employ a hand-down motion to use the device to insert a tampon. In another example, the user may be in a standing position or a crouching position. In such an example and others, the user will space her thighs apart and may use her other hand to spread the labia to facilitate insertion of the delivery device loaded with a tampon. The method may include moving the hand inwardly and upwardly in a curvilinear motion such that the longitudinal axis of the deployment orientation is tilted toward the lumbar region of the user's spine.

[0069] In some embodiments, the insertable is in a deployed orientation when the longitudinal axis of the insertable is substantially parallel to the longitudinal axis of the distal end of the finger orientation mechanism. In other embodiments, the insertable is in a deployed orientation when the longitudinal axis of the insertable is at an angle to the longitudinal axis of the distal end of the finger orientation mechanism. In preferred and alternative variations of this embodiment, the physical relationship between the insertable orientation mechanism and the finger orientation mechanism is configured such that a side view of the delivery device reflects an extended state of the natural curvature of a user's finger, particularly the natural curvature of an index finger.

[0070] In other particularly preferred embodiments, a portion of at least one finger is in the navigation orientation when the longitudinal axis of the at least one finger is substantially parallel to the longitudinal axis of the proximal end of the insertable object orienting mechanism. In some of these embodiments and in other embodiments, at least one orienting force is substantially aligned with the central axis of the orifice.

[0071] It is particularly preferred that the navigation orientation orients at least one finger to apply a plurality of directional forces to the insertable in the deployed orientation, the plurality of directional forces being suitable for guiding the insertable through the physical structure defining the aperture and / or guiding the insertable into the aperture.

[0072] In preferred embodiments, the delivery device is adapted such that advancement of the insertable through the physical structure defining the orifice can transmit proprioceptive and tactile cues to a portion of at least one finger through the base or divider of the insertable orienting mechanism, thereby enabling an informed selection of one or more directional forces necessary to guide the insertable through the physical structure defining the orifice and / or into the orifice. In some embodiments, the transmission of proprioceptive and tactile cues through the base or divider of the insertable orienting mechanism preferably occurs because the navigation orientation causes at least a portion of the finger to press against the divider.

[0073] However, in particularly preferred embodiments, proprioceptive and tactile cues are also transmitted to at least one finger of the user through the skirt member. This is because, in such embodiments, at least a portion of the skirt member surrounding the finger has a thickness that enables the user to feel the physical structure defining the orifice as if a glove were interposed between the user's finger and such physical structure.

[0074] As will be appreciated by those skilled in the art, the orifice into which the insert is deployed is an orifice inside an animal (including humans and non-human animals). Some embodiments of the delivery device are adapted so that an orifice inside an animal is accessible through an orifice external to the animal. In preferred and alternative embodiments, the orifice is an opening into the vagina, an opening into the anus, an opening into the urinary tract, an opening into the penis, a nostril, an opening into the ear, a mouth. In some alternative embodiments, the orifice is an opening into a wound or incision.

[0075] The delivery device of preferred and alternative embodiments is suitable for deploying various types of insertables. In some such embodiments, the insertable is a tampon, pessary, suppository, enema, a delivery device for delivering liquids, creams and / or lubricants, a clinical screening device, a swab or wiping device, a cream, a lubricant, a tablet, a capsule, a caplet, a pellet, a supplement, an implantable medical device or a surgical device, a therapeutic agent or other insertables suitable for having a therapeutic or diagnostic benefit. In yet other embodiments, the insertable can be an active or passive implant or a device such as a sensor for monitoring, alarming, recording or transmitting data recorded from an orifice (such as biological data), or an implantable therapeutic device for treating or medical intervention as required.

[0076] In some preferred embodiments, the delivery device can be a disposable device, which means that the delivery device is discarded after the insertable is deployed in the orifice. For example, such an embodiment is suitable for the embodiment in which the assembly of the delivery device and the insertable is packaged and / or sold as a single unit. However, the delivery device can also be a device that can be used repeatedly. In some such embodiments, no matter whether the delivery device carries the insertable when being packaged and / or sold or whether the insertable is loaded into the insertable directing mechanism, the user can clean the delivery device between multiple uses after the insertable has been deployed. When the insertable needs to be deployed next, the user can insert the insertable into the insertable directing mechanism, and then continue according to the previous situation.

[0077] The materials used to make the preferred embodiments of the delivery device are selected so that they exhibit one or more of the following properties: medical grade, moldable, reversible (including reversible without cracking), non-porous, flexible, resilient, durable, stable at room and shipping temperatures, water soluble, rapidly biodegradable, non-allergenic, approved by therapeutic regulatory agencies for use in pharmaceutical or ingested drug delivery, and have a shelf life of more than 2 years, more preferably 3 years, more preferably 5 years when stored according to storage instructions. In some preferred embodiments, another feature of the material is that the material does not decompose or melt when the delivery device is exposed to direct sunlight or in a location where the temperature exceeds normal room temperature.

[0078] In particularly preferred embodiments, the one or more materials forming the delivery device include a thermoplastic elastomer or a moldable bioplastic elastomer (including a biodegradable bioplastic thermoplastic elastomer).

[0079] Some other materials that can be used to make the delivery device include gelatin or potato starch, gel caps, plasticizers such as glycerol and sorbitol. Coloring or flavoring agents can also be incorporated into the manufacture of the delivery device.

[0080] Some specific materials from which the delivery device may be formed include, but are not limited to, those selected from the group consisting of: MOWIFLEX® from Kuraray Co., Ltd. TM , Mitsubishi Chemical Corporation's BioPBS TM , BIOPLAST of Bio-tec BiologscheNaturverpackungen GmbH&Co.KG TM TPS, REVODE213 of Zhejiang Hisun Biomaterials Co., Ltd. TM 、ZELAS of Mitsubishi Chemical Corporation TM , TEFABLOC of Mitsubishi Chemical Corporation TMOne or more products of the TOFI210 series and styrenic block copolymers, including but not limited to THERMOLAST from Kraton Polymers Research BV TMTM One or more of the M complexes.

[0081] In some preferred embodiments, the delivery device is made of a water-soluble material. In a particularly preferred embodiment, the device is made of a polyvinyl alcohol polymer (PVA / PVOH). In some preferred and alternative embodiments, the delivery device is made of one or more materials including a bioplastic elastomer including a biodegradable thermoplastic elastomer.

[0082] In some preferred embodiments, the material of the delivery device is a flushable material. According to the INDA / EDANA guidance document, the flushable material can be selected from: polyvinyl alcohol resin with fillers, natural polymer materials (such as carbohydrates, such as starch or cellulose), and plasticizers (such as polyols, such as glycerol or sorbitol). The polyvinyl alcohol resin raw material can include a low alcoholysis degree polyvinyl alcohol resin with an alcoholysis degree of about 80 mol% to 93 mol% and a high alcoholysis degree polyvinyl alcohol resin with an alcoholysis degree of about 93.1 mol% to 99.99 mol%, and the ratio of the low alcoholysis degree polyvinyl alcohol resin to the high alcoholysis degree polyvinyl alcohol resin is about 90:10 to 0:100 (weight ratio).

[0083] Suitable materials for forming the delivery device are further discussed below in conjunction with the manufacturing mold and manufacturing method aspects of the present invention.

[0084] According to a second aspect, the invention provides a method for finger-guided deployment of an insertable into an orifice, the method comprising:

[0085] a. Providing a delivery device according to the first aspect of the present invention, wherein the insertable is loaded into the insertable orientation mechanism and is positioned in a deployment orientation;

[0086] b. If the skirt member:

[0087] i. in the configuration surrounding the insertable, advancing a portion of at least one finger against an underside of the base of the insertable orienting mechanism so that the first portion of the skirt member forms a finger orienting mechanism adapted to position at least a portion of at least one finger in a navigation orientation adapted to guide deployment of the insertable into the orifice; or

[0088] ii. being between the configuration surrounding the insertable object and the configuration surrounding the finger or in the configuration surrounding the finger, advancing a portion of at least one finger into the finger orientation mechanism so that the finger is in the navigation orientation;

[0089] c. if not already in the configuration around the finger, deforming the skirt member into the configuration around the finger, thereby exposing the insertable object;

[0090] d. using at least one finger to guide the deployment of the insertable object into the orifice; and

[0091] e. Withdrawing the delivery device, leaving the insertable deployed in the orifice.

[0092] A method according to the second aspect of the present invention, wherein, after withdrawing the delivery device, the method further comprises moving the skirt member from the finger-surrounding configuration toward the insertable-surrounding configuration but not reaching the insertable-surrounding configuration, wherein at least some of the contents within any orifice withdrawn from the orifice are typically contained between overlapping portions of the orifice-contacting surface, on portions of the orifice-contacting surface facing the insertable orienting mechanism, and / or in and around the insertable orienting mechanism.

[0093] The method according to the second aspect of the present invention, wherein the finger is withdrawn from the finger orientation mechanism after the delivery device is withdrawn.

[0094] A method according to the second aspect of the invention, wherein the insertable object is a tampon with a retrieval string extending from a proximal end of the tampon, and the orifice is a vaginal orifice, and wherein the step of withdrawing the delivery device includes allowing the retrieval string to pass through a passage formed in the base of the insertable object orientation mechanism and out the distal end of the finger orientation mechanism, thereby allowing the retrieval string to extend or hang from the vaginal orifice.

[0095] Preferred and alternative embodiments of the method disclose that the step of advancing a portion of at least one finger into the finger orientation mechanism includes adjusting the positioning of the portion of at least one finger until the portion of at least one finger is in the navigation orientation. Various configurations of the positioning of the portion of at least one finger have been described differently throughout the specification for different embodiments of the delivery device.

[0096] For example, in some embodiments, the insertable is a tampon having a retrieval string extending from a proximal portion of the tampon body, and a passage is formed in a base or divider of the insertable orientation mechanism that is adapted to accommodate a cross-section of the retrieval string. According to some of these embodiments, a proximal end of the retrieval string is in a freely movable configuration within the finger orientation mechanism, or in a noodle-like configuration near a distal end of the finger orientation mechanism. For this type of embodiment, when a portion of at least one finger is inserted into the finger orientation mechanism, the retrieval string is compressively held between a portion of at least one finger and / or a side of the portion and an inner wall of the finger orientation mechanism and / or a distal end of the finger orientation mechanism.

[0097] According to some preferred embodiments of the method, the step of using at least one finger to guide the deployment of the insertable into the orifice includes applying at least one directional force such that the insertable is directed through the physical structure defining the orifice. In another preferred embodiment of this step, in response to proprioceptive and tactile cues being transmitted to a portion of at least one finger through the base or divider of the insertable orienting mechanism and / or through the portion of the skirt member surrounding the finger, the user selects one or more directional forces necessary to guide the insertable through the physical structure defining the orifice and / or into the orifice.

[0098] Additional steps and / or portions of steps associated with the method of the second aspect of the invention are also discussed above when describing the positioning and alignment of the finger orientation mechanism and the insertable orientation mechanism for deploying the insertable into the orifice.

[0099] According to a third aspect, the present invention provides a manufacturing mould suitable for moulding a delivery device according to the first aspect of the present invention.

[0100] Preferably, the manufacturing mold comprises at least one core plate and at least one cavity plate. In alternative embodiments, more than one core plate and more than one cavity plate may be used for the manufacturing mold.

[0101] In a preferred embodiment, the manufacturing mold further comprises at least two gates adapted to receive the material in molten form to fill the mold cavity, thereby molding the delivery device. In a particularly preferred embodiment, at least three gates are used.

[0102] In some preferred and alternative embodiments, at least three gates are selectively positioned substantially circumferentially and distributed substantially equidistantly around the skirt member and spaced a predetermined distance apart relative to where the skirt member extends from the insertable object orientation mechanism. Preferably, the predetermined distance for selectively positioning the at least three gates is determined by reference to the position of the delivery device to be molded between the configuration surrounding the insertable object and the configuration surrounding the finger when the mold is set up to mold the delivery device.

[0103] In an embodiment where the mold is configured to mold a delivery device, wherein the skirt member:

[0104] In the wrap-around insertable configuration, the predetermined distance is preferably about 0.1% to about 5% of the length of the skirt;

[0105] approximately midway between the around-the-insert configuration and the around-the-finger configuration, the predetermined distance preferably being from about 5% to about 25% of the length of the skirt; and

[0106] In the configuration for encircling the finger, the predetermined distance is preferably from about 95% to about 95.9% of the length of the skirt.

[0107] In embodiments where the mold is configured to mold a delivery device and wherein the skirt member is in the configurations listed in the above 3 points, a person skilled in the art may refer to the information in these 3 points to estimate the predetermined distances for selectively positioning at least three gates.

[0108] In alternative embodiments, different numbers of gates may be used at different locations around the manufacturing mold. The number of gates and appropriate locations of the gates are preferably identified by reference to the equipment and machinery available in a particular manufacturing plant, and the goal is to provide a mold that satisfies the delivery device described in the first aspect of the present invention. In an alternative embodiment, by way of example only, at least three gates are selectively positioned adjacent to the end of the skirt member.

[0109] Preferred and alternative embodiments of the manufacturing mold are suitable for molding the delivery device from a suitable material that is suitable for the application that the delivery device is to be used in. In particularly preferred embodiments, the material has a Shore hardness value of about 20 to about 60 on the Shore hardness scale A. For embodiments of the delivery device suitable for use in medical or paramedical applications, the material used will preferably also meet biocompatibility certification standards.

[0110] The material used to form the delivery device is preferably selected from the group consisting of: thermoplastic elastomers (TPE), thermoplastic polyurethanes (TPU), polyvinyl alcohol (PVA or PVOH), silicone or silicone equivalents, and other bioplastics or other materials having substantially similar performance characteristics to any of these materials. However, as mentioned above, there are other materials suitable for forming the delivery device of the first aspect of the invention.

[0111] According to a fourth aspect, the present invention provides a delivery device moulded using the manufacturing mould of the third aspect of the present invention.

[0112] According to a fifth aspect, the present invention provides a manufacturing jig for assembling a delivery device according to the first aspect of the present invention and an insertable, the manufacturing jig comprising an insertable loading mechanism adapted to load the insertable into the insertable orienting mechanism.

[0113] Preferably, the insertable loading mechanism comprises:

[0114] a. a delivery device support member adapted to support the delivery device so that the delivery device is oriented to receive the insertable object loaded into the insertable object orientation mechanism; and

[0115] b. An insertable support member adapted to support the insertable for loading the insertable into the insertable orienting mechanism.

[0116] Preferred and alternative embodiments of manufacturing the jig provide for the components of the jig to be in a generally unitary track-like arrangement.Preferably, the insertable support member is located distally of the delivery device support member.

[0117] In some preferred embodiments, the insertable has a longitudinal axis and a retrieval line extending generally from the insertable, and the insertable support member is adapted to support the insertable so that the longitudinal axis of the insertable is generally aligned with the first longitudinal axis of the insertable orienting mechanism and the proximal end of the insertable generally faces the insertable orienting mechanism. In some such embodiments, the insertable is a tampon.

[0118] Some preferred and alternative embodiments of the manufacturing jig (which is adapted to facilitate loading of an insertable having a retrieval wire) further include a retrieval wire pulling mechanism having a longitudinal axis and adapted to engage with a proximal end of the retrieval wire for pulling the retrieval wire through a passage formed in a base or divider of the insertable orienting mechanism. In some such embodiments, the retrieval wire pulling mechanism includes a wire engaging mechanism to which the proximal end of the retrieval wire can be engaged.

[0119] Preferably, the longitudinal axis of the retrieval wire pulling mechanism is configured to be substantially aligned with the first longitudinal axis of the insertable object orienting mechanism.

[0120] In preferred and alternative embodiments, the retrieval wire pull mechanism is further adapted to form the passageway in a base or partition of the insertable orienting mechanism. Some such embodiments provide that the retrieval wire pull mechanism further comprises a piercing mechanism adjacent to the wire engagement mechanism. The piercing mechanism of preferred and some alternative embodiments is a sharp member capable of penetrating a base or partition of the orienting mechanism.

[0121] In some preferred embodiments, the cross-sectional shape of the retrieval wire pulling mechanism including the puncture mechanism is substantially the same as the cross-sectional shape of the retrieval wire. Preferably, the cross-sectional shape of the retrieval wire pulling mechanism is sized to be adapted to matingly but releasably engage the retrieval wire. In other preferred embodiments, the puncture mechanism creates a single point puncture or a slit puncture that closes on the inserted one or more retrieval wires to apply a retaining force and preferably minimizes possible contact between a finger and an insertable object.

[0122] In the track-like arrangement and in other arrangements, the retrieval wire pull mechanism is preferably located on the proximal side of the delivery device support member. In some preferred embodiments, the retrieval wire pull mechanism is adapted to be movable along a longitudinal axis of the retrieval wire pull mechanism, and wherein when the retrieval wire pull mechanism is advanced toward the delivery device support mechanism, the piercing mechanism forms a passage in the base or partition of the insertable orienting mechanism and extends toward the insertable support member.

[0123] In a preferred embodiment, the retrieval wire pulling mechanism pulls the proximal end of the retrieval wire through a passage in the base or partition of the insertable orienting mechanism as the retrieval wire pulling mechanism moves away from the insertable orienting mechanism.

[0124] In some embodiments, the engagement of the proximal end of the retrieval wire with the wire engagement mechanism is achieved by cinch-engaging the proximal end of the retrieval wire with a portion of the retrieval wire pulling mechanism. In alternative embodiments, the proximal end of the retrieval wire may be engaged with the wire engagement mechanism by hook engagement, glue point engagement, or by any other form of engagement that will enable the proximal end of the retrieval wire to remain engaged with the wire engagement mechanism as the piercing mechanism pulls the retrieval wire back through a passage formed in the base member or divider of the insertable orienting mechanism.

[0125] The proximal end of the insertable preferably engages the insertable orienting mechanism as the retrieval wire pulling mechanism pulls the retrieval wire back through a passage formed in a base member or divider of the insertable orienting mechanism, thereby loading the insertable into the insertable orienting mechanism. In a preferred embodiment, the proximal end of the retrieval wire is disengaged from the retrieval wire pulling mechanism after the insertable is loaded into the insertable orienting mechanism.

[0126] In other preferred embodiments and some alternative embodiments, the manufacturing jig of the fifth aspect of the present invention further comprises a retrieval wire placement mechanism adapted to place a section of retrieval wire that has been pulled through the passageway near the distal end of the finger orientation mechanism.

[0127] In some preferred embodiments, the section of retrieval line placed near the distal end of the finger orientation mechanism is in a noodle-like configuration. Preferably, the retrieval line placement mechanism includes an air source, which is suitable for blowing the section of retrieval line near the distal end of the finger orientation mechanism. However, in alternative embodiments, the retrieval line placement mechanism can take other forms, such as a guide member suitable for guiding the section of retrieval line near the distal end of the finger orientation mechanism.

[0128] According to a sixth aspect, the present invention provides a method for manufacturing an assembly of a delivery device and an insertable object, the method comprising:

[0129] a. Providing a manufacturing mold according to the third aspect of the present invention, an insert, a material for making a delivery device, and a manufacturing jig according to the fifth aspect of the present invention;

[0130] b. heating the manufacturing mold to a temperature capable of maintaining the material in a molten form, and introducing the molten material into the manufacturing mold;

[0131] c. cooling the manufacturing mold so that the molten material solidifies to form the delivery device, and removing the mold;

[0132] d. loading the formed delivery device and the insert into the manufacturing jig; and

[0133] e. Loading the insertable into the insertable orienting mechanism using the manufacturing jig.

[0134] According to the manufacturing method described in the sixth aspect of the present invention, the step of introducing the molten material into the manufacturing mold is performed under a pressure sufficient to allow the molten material to uniformly fill the mold.

[0135] The manufacturing method of the sixth aspect of the present invention further comprises packaging the delivery device and the insertable component. Preferably, the packaging is formed of a biodegradable material and can also be configured to contain the delivery device and the insertable component so as to substantially prevent the ingress of contaminants.

[0136] In some preferred embodiments, the manufacturing method of the sixth aspect of the present invention uses a process flow technology in which individual processing stations are arranged on a rotating table or along a linear delivery machine, or a robotic arm is used to perform the manufacturing task of forming a defined delivery device.

[0137] According to a seventh aspect, the present invention provides an assembly of a delivery device and an insertable manufactured by the manufacturing method of the sixth aspect of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0138] The present invention is explained in detail below with reference to the accompanying drawings, in which:

[0139] Figure 1 is a cross-sectional view of a delivery device loaded with a tampon according to one embodiment of the present invention. The skirt member of the delivery device is located between a configuration surrounding an insertable object and a configuration surrounding a finger;

[0140] Figure 2 yes Figure 1 a cross-sectional view of the delivery device shown wherein the skirt member has been moved in a direction of a configuration around a finger;

[0141] Figure 3 yes Figure 1 a cross-sectional view of the delivery device shown with the skirt member generally in a configuration to encircle a finger;

[0142] Figure 4 yes Figure 1 a cross-sectional view of the delivery device depicting the tampon having been released from the insertable orienting mechanism;

[0143] Figure 5 is a perspective view of a delivery device according to one embodiment of the present invention, viewing the skirt member toward the insertable orienting mechanism. The insertable is not depicted in this view;

[0144] Figure 6 yes Figure 5 a perspective view of the delivery device shown viewing the skirt member toward the finger orientation mechanism;

[0145] Figure 7 is a perspective view of a delivery device according to one embodiment of the present invention, the perspective view viewing the skirt member toward the insertable object orienting mechanism. The insertable depicted in this view is a tampon;

[0146] Figure 8 yes Figure 7 a perspective view of the delivery device shown with a tampon loaded therein, the perspective view viewing the skirt member toward the finger orientation mechanism;

[0147] Fig. 9 is a cross-sectional view of a delivery device according to one embodiment of the present invention loaded with a tampon and with a lubricating mechanism according to one embodiment of the present invention in the form of an "S" shaped kink formed in the wall of the skirt member;

[0148] Fig.10 yes Fig. 9 A cross-sectional view of a delivery device is shown. The depicted delivery device includes an insertable ejection mechanism according to one embodiment of the present invention;

[0149] Fig.11 yes Fig. 9 A cross-sectional view of the delivery device is shown, illustrating the changing process of the skirt member;

[0150] Fig.12 yes Fig. 9 a cross-sectional view of the delivery device shown wherein the skirt member has been moved in a direction of a configuration around a finger;

[0151] Fig.13 yes Fig. 9 a cross-sectional view of the delivery device shown with the skirt member generally in a configuration to encircle a finger;

[0152] Fig.14 is a perspective view of a delivery device according to one embodiment of the present invention, the perspective view viewing the skirt member toward the insertable object orienting mechanism. The insertable depicted in this view is a tampon;

[0153] Fig.15 yes Fig.14 a perspective view of the delivery device shown with a tampon loaded therein, the perspective view viewing the skirt member toward the finger orientation mechanism;

[0154] Fig.16 is a side view of a delivery device according to one embodiment of the present invention, wherein the skirt member is generally in a configuration surrounding an insertable;

[0155] Fig.17 yes Fig.16 a cross-sectional view of a delivery device shown with a lubricating mechanism in accordance with one embodiment of the present invention in the form of a pattern of projections and depressions formed on the wall of a skirt member;

[0156] Fig.18 yes Fig.17 An enlarged view of the lubrication mechanism shown;

[0157] Fig.19 is a cross-sectional view of a delivery device loaded with a suppository according to one embodiment of the present invention. The skirt member of the delivery device is located between a configuration surrounding an insertable object and a configuration surrounding a finger;

[0158] Fig. 20 is a cross-sectional view of a delivery device loaded with a donut-type pessary according to one embodiment of the present invention. The skirt member of the delivery device is located between a configuration surrounding an insertable object and a configuration surrounding a finger;

[0159] Fig.21 is a perspective view of a delivery device according to one embodiment of the present invention, depicting the contents of an orifice after an insertable is deployed into the orifice, the contents of the orifice being positioned over and around an insertable orienting mechanism;

[0160] Fig. 22 yes Fig.21 a perspective view of the delivery device shown with the skirt member in a disposable configuration or near a disposable configuration;

[0161] Fig.23 is a perspective view of a manufacturing jig according to one embodiment of the present invention. The delivery device is not loaded in this figure;

[0162] Fig.24 According to one embodiment of the present invention, Fig.23 An enlarged view of a delivery device support member of a manufacturing jig is shown;

[0163] Fig.25 According to one embodiment of the present invention, Fig.23 An enlarged view of the retrieval wire mechanism of the manufacturing jig shown;

[0164] Fig.26 yes Fig.23 Different perspective views of the manufacturing jig shown;

[0165] Fig. 27 yes Fig.25 An enlarged view of the engagement portion of the retrieval line pulling mechanism is shown;

[0166] Fig.28 According to one embodiment of the present invention, Fig.23 An enlarged view of the proximal end of an insertable support member of a manufacturing jig is shown.

[0167] Fig.29 yes Fig.23 A perspective view of a manufacturing jig is shown in which a delivery device is loaded into Fig.24 On the delivery device support member shown;

[0168] Fig.30yes Fig.23 Various perspective views of a manufacturing jig are shown with a tampon loaded into an insertable support member. A retrieval wire pull mechanism is shown forming a passageway for the retrieval wire in a base of the insertable orienting mechanism, and the retrieval wire is shown engaged with the retrieval wire pull mechanism;

[0169] Fig.31 is an enlarged view of the tampon retrieval cord engaged with the retrieval cord pulling mechanism;

[0170] Fig.32 yes Fig.30 A perspective view of a manufacturing jig is shown illustrating that the retrieval cord pulling mechanism has pulled the tampon retrieval cord through a passage in the base of the insertable orienting mechanism. The tampon is not visible because it is located in the insertable orienting mechanism of the delivery device;

[0171] Fig.33 yes Fig.32 an enlarged view of the manufacturing jig shown with the tampon retrieval cord disengaged from the retrieval cord pulling mechanism;

[0172] Fig.34 After the delivery device and insertable assembly has been removed from the manufacturing jig Fig.30 An enlarged view of a manufacturing jig is shown. A delivery device loaded with a tampon is illustrated adjacent to an enlarged view of the manufacturing jig. A perspective view of the delivery device viewing the skirt member toward the finger orientation mechanism. The tampon retrieval line is depicted as a noodle-like form adjacent the distal end of the finger orientation mechanism;

[0173] Fig.35 1 is a perspective view of a core plate device for manufacturing a mold according to one embodiment of the present invention. An injection port left from a material entering a gate and a delivery device formed using a mold are respectively shown between the related core plates to illustrate the molding process; and

[0174] Fig.36 is with Fig.35 A perspective view of a cavity plate assembly corresponding to the core plate assembly of the mold is shown in FIG. The remaining sprue and the formed delivery device are shown again separately between the relevant cavity plates to illustrate the molding process. DETAILED DESCRIPTION

[0175] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Although the drawings tend to illustrate embodiments in which the insertable or deployable article is a tampon, as has been explained elsewhere in this specification and is apparent to those skilled in the art, the insertable or deployable article may take many other forms. All of these forms are within the scope of the present invention.

[0176] The figure illustrates a delivery device 10 for deploying an insertable object 20 into an orifice guided by a finger 30. Broadly speaking, the delivery device 10 comprises:

[0177] an insertable orienting mechanism 11 having a first longitudinal axis 15 and a base 12, the insertable orienting mechanism 11 being adapted to load an insertable 20 and position the insertable 20 in a deployed orientation 14, and

[0178] A skirt member 40 extending from adjacent the insertable orienting mechanism 11 and having a skirt length and including opposing finger contacting surfaces 49 and an orifice contacting surface 50, wherein the skirt member 40 is adapted to be generally parallel to the first longitudinal axis and movable along the skirt length between the following configurations:

[0179] a surrounding insertable configuration 41 wherein the aperture contacting segment of aperture contacting surface 50 generally faces insertable orienting mechanism 11 and any loaded insertable 20; and

[0180] A finger-encircling configuration 42 wherein the aperture-contacting segment of aperture-contacting surface 50 faces generally away from insertable orienting mechanism 11 and any loaded insertable 20 .

[0181] As skirt member 40 moves along the length of the skirt from a configuration 41 around the insertable object toward a configuration 42 around the finger, a first portion of skirt member 40 is adapted to form a finger orientation mechanism 13 adapted to position at least a portion of at least one finger 30 in a navigation orientation 16 adapted to guide deployment of insertable object 20 into the orifice. Preferably, a distal end of finger orientation mechanism 13 is located on the underside of base 12 of the insertable object orientation mechanism.

[0182] The finger orientation mechanism 13 includes a finger engagement mechanism adapted to temporarily engage at least a portion of the finger 30 adjacent to the first portion of the skirt member 40. Preferably, the finger engagement mechanism 13 includes a roughened or otherwise patterned section of the first portion of the skirt member 40 adapted to create a substantially mating engagement between the finger orientation mechanism 13 and at least a portion of the finger 30 to releasably retain the finger 30 in the navigation orientation 16.

[0183] The skirt member 40 of the preferred embodiment extends from near the insertable orienting mechanism 11. Preferably, near the location where the skirt member 40 extends from near the insertable orienting mechanism 11, the skirt member 40 rotates about itself so that when the skirt member 40 is extended from the configuration 41 around the insertable toward the configuration 42 around the finger, the first portion of the contact aperture segment can face or contact the second portion of the contact aperture segment. The section where the skirt member 40 rotates about itself is the inflection point.

[0184] The movement of the skirt member 40 along the length of the skirt from the configuration 41 surrounding the insertable toward the configuration 42 surrounding the finger accordingly causes the finger contacting segment of the finger contacting surface 49 to face or contact at least a portion of at least one finger 30 when the finger 30 is surrounded by the skirt member 40. The underside of the base 12 of the insertable orientation mechanism is pushed to cause the skirt member 40 to move from the configuration 41 surrounding the insertable toward the configuration 42 surrounding the finger, so that the first portion of the skirt member 40 forms the finger orientation mechanism 13. In other preferred embodiments, the distal end of the skirt member 44 is pulled to cause the skirt member to move from the configuration 41 surrounding the insertable toward the configuration 42 surrounding the finger, so that the first portion of the skirt member 40 forms the finger orientation mechanism 13. In some further preferred embodiments, when the underside of the base 12 of the insertable object orienting mechanism is pushed and the skirt member 40 is pulled, the skirt member 40 moves from a configuration 41 surrounding the insertable object toward a configuration 42 surrounding the finger, and the first portion of the skirt member 40 forms the finger orienting mechanism 13.

[0185] Preferably, the movement of the skirt member 40 along the length of the skirt from the configuration 41 around the insertable toward the configuration 42 around the finger accordingly causes a first portion of the aperture-contacting segment of the aperture-contacting surface 50 to face or contact a second portion of the aperture-contacting segment of the aperture-contacting surface 50. In some preferred embodiments, this occurs as the skirt member 40 moves about its inflection point. As the skirt member 40 approaches the configuration 42 around the finger, at least a portion of the aperture-contacting surface 50 reaches a position where, when any loaded insertable 20 is inserted into the aperture, at least a portion of the aperture-contacting surface 50 faces or can contact the inside of the aperture.

[0186] When the skirt member 40 is in the finger-encircling configuration 42, substantially all of the finger-contacting segments of the finger-contacting surface 50 face or contact at least a portion of at least one finger 30 when the finger 30 is surrounded by the skirt member 40, and substantially all of the orifice-contacting segments of the orifice-contacting surface 50 may face the inner side of the orifice or may contact the inner side of the orifice.

[0187] When skirt member 40 is in configuration 42 around the finger, the portion of insertable orientation mechanism 11 facing the orifice can face and contact the inner side of the orifice, and any loaded insertable 20 can face and contact the inner side of the orifice. In some such embodiments, the portion of insertable orientation mechanism 11 facing the orifice and the loaded insertable 20 are exposed and ready for insertable 20 to be deployed into the orifice. As skirt member 40 gets closer to configuration 41 around the insertable, at least a portion of surface 50 contacting the orifice can face or can contact the portion of insertable orientation mechanism 11 facing the orifice and any loaded insertable 20.

[0188] Movement of the skirt member 40 along the length of the skirt from the configuration 42 surrounding the finger toward the configuration 41 surrounding the insertable object causes the finger contacting segment of the finger contacting surface 50 to turn away from, or disengage from, at least a portion of any finger 30 located in the finger orientation mechanism 13.

[0189] When skirt member 40 is in configuration 41 surrounding the insertable, preferably, substantially all of the orifice-contacting segment of surface 50 contacting the orifice faces the orifice-facing portion of insertable orienting mechanism 11 and any loaded insertable 20 for deployment, and substantially all of the finger-contacting segment of surface 50 contacting the finger faces away from insertable orienting mechanism 11 and any loaded insertable 20 for deployment.

[0190] like Fig. 22 As illustrated, after insertable 20 is deployed into the orifice, skirt member 40 may move from configuration 42 around the finger toward configuration 41 around the insertable, but not to configuration 41 around the insertable, to be in disposable configuration 43. Preferably, when delivery device 10 is in disposable configuration 43, at least some of the contents 48 within any orifice that are withdrawn when delivery device 10 is withdrawn from the orifice may be substantially contained between overlapping portions of surface 50 that contacts the orifice, on portions of surface 50 that contacts the orifice that face insertable orienting mechanism 11, and / or in and around insertable orienting mechanism 11.

[0191] When the delivery device 10 is in the disposable configuration 43, preferably, the mutually overlapping portions of the surface 50 that contacts the orifice and other portions of the surface 50 that contacts the orifice are generally concentrically arranged around the finger orientation mechanism 13 and the insertable orientation mechanism 11. The length of the generally concentrically arranged portions is about one-quarter to about three-eighths of the length of the delivery device in the configuration 42 that surrounds the finger. The disposable configuration 43 is suitable for facilitating the sanitary disposal of the delivery device 10 after the insertable 20 is inserted into the orifice.

[0192] The delivery device 10 also includes at least one lubricating mechanism 18 along, associated with, or applied to at least a portion of the skirt length, the lubricating mechanism being adapted to facilitate movement of the skirt member 40 along the skirt length between the configuration 41 surrounding the insertable object and the configuration 42 surrounding the finger. Each lubricating mechanism 18 is preferably selected from the group consisting of: an indentation formed in the wall of the skirt member 40, a kink formed in the wall of the skirt member 40, a pattern of protrusions, a pattern of depressions, or a pattern of protrusions and depressions formed on the wall of the skirt member 40, and a lubricating composition applied to a portion of the surface 50 that contacts the orifice.

[0193] Figures 9 to 15 An embodiment of a delivery device 10 is depicted in which one lubrication mechanism 18 comprises a kink formed in the wall of a skirt member 40. The kink 18 depicted in the figure is generally S-shaped in longitudinal cross-section, thereby creating concave and convex inflection points about which the skirt member can rotate. By providing an additional inflection point about which the skirt member 40 can rotate, movement of one portion of the surface 50 that contacts the orifice over another portion of the surface 50 that contacts the orifice is facilitated.

[0194] Figures 16 to 18 An embodiment of a delivery device 10 is depicted in which a lubricating mechanism 18 comprises a pattern of projections, a pattern of depressions, or a pattern of projections and depressions formed on the wall of the skirt member 40. The pattern 18 of the preferred embodiment consists of a plurality of hemispherical dimples arranged in a hexagonal pattern and repeated near each wall of each hexagon, such as Fig.17 and Fig.18 As shown, Fig.18 This is an enlarged view of the pattern.

[0195] The base 12 of the insertable orienting mechanism of the preferred embodiment forms the bottom of the generally U-shaped longitudinal cross-section of the insertable orienting mechanism. Preferably, the opposing arm portions of the generally U-shaped shape are adapted to provide support for temporarily holding the insertable 20 in the deployment orientation 14. In still other preferred embodiments, when the insertable 20 is in the insertable orienting mechanism 11, the proximal end 21 of the insertable 20 is adjacent to or more preferably in contact with the upper side of the base 14 of the insertable orienting mechanism (at the bottom of the U-shaped insertable orienting mechanism 11), so that the proximal end 21 of the insertable 20 is held within the U-shape. In some embodiments, the stiffness of some or all of the U-shaped insertable orienting mechanism 11 is greater than the stiffness of the skirt member 40.

[0196] In some preferred embodiments, the longitudinal cross-section of the finger orientation mechanism portion 13 of the insertable orientation mechanism 11 and the skirt member 40 has a generally H-shaped shape. Preferably, the opposing arm portions at the bottom of the H-shaped shape are adapted to provide support for temporarily holding the finger 30 in the navigation orientation 16. In some such embodiments, when a portion of at least one finger 30 is located in the finger orientation mechanism 13, the distal end of at least one finger 30 is adjacent to or more preferably in contact with the underside of the base 12 of the insertable orientation mechanism, which in these embodiments is formed by the top of the generally ∩-shaped component of the generally H-shaped shape. Preferably, the distal end of the finger 30 is held within the ∩-shaped shape. In some embodiments, the stiffness of some or all of the H-shaped longitudinal cross-sections of the finger orientation mechanism 13 portions of the insertable orientation mechanism 11 and the skirt member 40 is greater than the stiffness of the remaining portions of the skirt member 40.

[0197] The base 12 of the insertable orienting mechanism of some preferred embodiments includes a divider 19 adapted to separate the insertable 20 oriented for deployment from the finger 30 located in the finger orienting mechanism 13. The cross-section of the insertable orienting mechanism 11 is generally circular or generally elliptical. However, the cross-sectional shape of the insertable orienting mechanism 11 is generally determined by considering the cross-sectional shape of the insertable 20 to be loaded into the delivery device for deployment. When the insertable 20 to be loaded into the delivery device 10 is, for example, a tampon 100 or a Fig.19 When the insertable object 20 to be loaded into the delivery device 10 is a pessary (e.g., Fig. 20 When insertable orienting mechanism 11 is used as a donut-type pessary as depicted, the cross-sectional shape of insertable orienting mechanism 11 will preferably be oval or other cross-sectional shape that is compatible with the cross-sectional shape of a donut-type pessary.

[0198] Likewise, preferred embodiments of the finger orientation mechanism 13 provide a variety of cross-sectional shapes. However, it is particularly preferred that the finger orientation mechanism 13 has a generally circular cross-section that is suitable for accommodating at least a portion of at least one finger 30.

[0199] Fig.10 2 is depicted in the figure, which is adapted to facilitate the ejection of the insertable object 20 from the insertable object orientation mechanism 11. Preferably, the insertable ejection mechanism 32 is positioned on the underside of the base 12 of the insertable orientation mechanism, adjacent to the distal portion of at least one finger 30 located in the finger orientation mechanism 13. Fig.10It can be seen that insertable ejection mechanism 32 is generally housed within finger orientation mechanism 13 and is a depressible member that can be depressed by the distal portion of at least one finger 30 located in finger orientation mechanism 13, thereby causing proximal end 21 of insertable 20 to be ejected from insertable orientation mechanism 11. Insertable ejection mechanism 32 is not depicted in the drawings of other embodiments. However, insertable ejection mechanism 32 may also form part of such other embodiments.

[0200] like Fig.10 As shown, the distal segment of nail 31 may be received in a portion of finger orientation mechanism 13 adjacent insertable object ejection mechanism 32 .

[0201] Skirt member 40 of some embodiments further includes insertable component receiving mechanism 47 adapted to receive components of insertable 20 . Figures 9 to 15 Some such embodiments are described in Fig.14 and Fig.15 A preferred embodiment of the insertable component receiving mechanism 47 is clearly depicted in FIG. 1 , wherein the mechanism is formed by a wide slit-type channel of the skirt member 40 that opens at the distal end 44 of the skirt member 40 and extends along at least a portion of the length of the skirt.

[0202] The shape and / or size of insertable orienting mechanism 11 is preferably relatively smaller than at least a portion of insertable 20, so that at least a portion of insertable 20 is temporarily accommodated in the proximal portion of insertable orienting mechanism 11 because the proximal end 21 of the insertable is forcibly inserted into insertable orienting mechanism 11 during manufacturing or through manual manipulation by the user (for example, when reloading the delivery device).

[0203] In embodiments where the insertable 20 has additional components such as a retrieval string 102, as is the case with tampons 100, an aperture may be formed in the base 12 or divider 19 of the insertable orientation mechanism to allow passage of the retrieval string 102 (for enabling removal of the tampon 100 from the vaginal cavity), which typically extends from the proximal portion 101 of commercially available tampons 100. Some embodiments of the delivery device 10 that allow passage of the retrieval string 102 through the base 12 or divider 19 of the insertable orientation mechanism are adapted such that the aperture for receiving the retrieval string 102 has a diameter or widest portion that is only minimally larger than the cross-section of the retrieval string 102. In particularly preferred embodiments, the passageway is configured such that the degree of fluid communication through the thickness of the base 12 or divider 19 of the insertable orientation mechanism is preferably minimized.

[0204] Finger orientation mechanism 13 of the preferred embodiment also includes a portion adapted to snugly hold a portion of at least one finger 30 in navigation orientation 16. Navigation orientation 16 is such that in the navigation orientation, a portion of at least one finger 30 is oriented to apply at least one directional force to insertable object 20 in deployment orientation 14 to deploy the insertable object through the physical structure defining the orifice. Deployment orientation 14 has a longitudinal axis 15, and navigation orientation 16 has a longitudinal axis 17, and deployment orientation 14 and navigation orientation 16 are arranged such that deployment orientation longitudinal axis 15 and navigation orientation longitudinal axis 17 are generally parallel to each other, generally aligned with each other, or intersect at an angle adapted to facilitate deployment of insertable object 20 into the orifice.

[0205] It is particularly preferred that the navigation orientation 16 orients at least one finger 30 to apply multiple directional forces to the insertable 20 in the deployment orientation 14, wherein the multiple directional forces are suitable for guiding the insertable 20 through the physical structure defining the orifice and / or guiding the insertable into the orifice, or into the destination location of the insertable 20.

[0206] In preferred embodiments, delivery device 10 is adapted such that advancement of insertable 20 through a physical structure defining an orifice can deliver proprioceptive and tactile cues to a portion of at least one finger 30 through base 12 of the insertable orienting mechanism or through divider 19, thereby enabling an informed selection of one or more directional forces necessary to guide insertable 20 through the physical structure defining an orifice and / or into the orifice or into a destination location for insertable 20. In some embodiments, delivery of proprioceptive and tactile cues through base 12 or divider 19 of the insertable orienting mechanism preferably occurs because navigation orientation 16 causes at least a portion of finger 30 to press upwardly against an underside of base 12 or divider 19 of the insertable orienting mechanism.

[0207] However, in particularly preferred embodiments, proprioceptive and tactile cues are also transmitted to at least one finger 30 of the user through the skirt member 40. This is because, in such embodiments, at least a portion of the skirt member 40 surrounding the finger 30 has a thickness that enables the user to feel the physical structure defining the orifice, which acts similar to a single glove layer interposed between the user's finger and such physical structure.

[0208] Also disclosed is a method for deploying an insertable object 20 into an orifice guided by a finger 30, wherein the method comprises:

[0209] a. providing a delivery device 10, wherein the insertable object 20 is loaded into the insertable orientation mechanism 11 and is positioned in a deployment orientation 14;

[0210] b. If the skirt member 40:

[0211] i. in the configuration 41 surrounding the insertable object, a portion of at least one finger 30 is advanced against the underside of the base 12 of the insertable object orientation mechanism, so that the first portion of the skirt member 40 forms a finger orientation mechanism 13, which is suitable for positioning at least a portion of at least one finger 30 in a navigation orientation 16, and the navigation orientation 16 is suitable for guiding the deployment of the insertable object 20 into the orifice; or

[0212] ii. between the configuration 41 surrounding the insertable object and the configuration 42 surrounding the finger or in the configuration 42 surrounding the finger, advancing at least a portion of the finger 30 into the finger orientation mechanism 13, so that the finger 30 is in the navigation orientation 16;

[0213] c. if not already in the configuration 42 around the finger, the skirt member 40 is deformed into the configuration 42 around the finger, thereby exposing the insertable 20;

[0214] d. deploying the insertable object 20 into the orifice using the at least one finger 30 to guide; and

[0215] e. Withdrawal of delivery device 10, leaving insertable 20 deployed in the orifice.

[0216] After withdrawing the delivery device 10, the method further includes moving the skirt member 40 from the finger-encircling configuration 42 toward, but not to, the insertable-encircling configuration 41, wherein at least some of any orifice-inside contents 48 withdrawn from the orifice are generally contained between overlapping portions of the orifice-contacting surface 50, on portions of the orifice-contacting surface 50 that face the insertable orienting mechanism 11, and / or in and around the insertable orienting mechanism 11. Likewise, after withdrawing the delivery device 10, the finger 30 is withdrawn from the finger orienting mechanism 13.

[0217] The step of advancing the portion of the at least one finger 30 into the finger orientation mechanism 13 includes adjusting the positioning of the portion of the at least one finger 30 until the portion of the at least one finger 30 is in the navigation orientation 16 .

[0218] In some preferred embodiments, the insertable 20 is a tampon 100 having a retrieval string 102 extending from a proximal portion 101 of the body of the tampon 100, and a passageway adapted to accommodate a cross-section of the retrieval string 102 is formed in the base 12 or the partition 19 of the insertable orientation mechanism. The proximal end 103 of the retrieval string 102 is in a freely movable configuration within the finger orientation mechanism 13, or in a noodle-like configuration near the distal end of the finger orientation mechanism 13. For this type of embodiment, when a portion of at least one finger 30 is inserted into the finger orientation mechanism 13, the retrieval string 102 is compressively held between a portion of at least one finger 30 and / or a side of the portion and an inner wall of the finger orientation mechanism 13 and / or the distal end of the finger orientation mechanism 13.

[0219] The step of directing the deployment of the insertable object 20 into the orifice using at least one finger 30 includes applying at least one directing force such that the insertable object is directed through the physical structure defining the orifice. In another preferred embodiment of this step, in response to proprioceptive and tactile cues being transmitted to a portion of at least one finger 20 through the base 12 or divider 19 of the insertable orienting mechanism and / or through the portion of the skirt member 40 surrounding the finger 30, the user selects one or more directing forces necessary to direct the insertable object 20 through the physical structure defining the orifice and / or into the orifice or into a destination location within the orifice.

[0220] Also disclosed is a manufacturing mold 60 suitable for molding the delivery device 10. Preferably, the manufacturing mold 60 includes at least one core plate 61 and at least one cavity plate 62. The manufacturing mold 60 also includes at least three gates (shown as sprues 63 remaining after molding) that are suitable for receiving material in a molten form to fill the cavity of the mold 60, thereby molding the delivery device 10.

[0221] At least three gates (shown as sprues 63 remaining after molding) are selectively positioned generally circumferentially and distributed generally equidistantly around the skirt member 40, and are spaced apart a predetermined distance relative to where the skirt member 40 extends from the insertable orienting mechanism 11. Preferably, the predetermined distance for selectively positioning the at least three gates is determined by reference to the position of the delivery device 10 to be molded between the configuration 41 surrounding the insertable and the configuration 42 surrounding the finger when the mold 60 is set to mold the delivery device 10.

[0222] In an embodiment where the mold 60 is configured to mold the delivery device 10, wherein the skirt member 40:

[0223] In the wrap-around insert configuration 41, the predetermined distance is preferably about 0.1% to about 5% of the length of the skirt;

[0224] approximately midway between the insert-encircling configuration 41 and the finger-encircling configuration 42, the predetermined distance preferably being from about 5% to about 25% of the length of the skirt; and

[0225] In the finger-encircling configuration 42, the predetermined distance is preferably from about 95% to about 95.9% of the skirt length.

[0226] Preferred embodiments of the manufacturing mold 60 are suitable for molding the delivery device 10 from a suitable material that is suitable for the application in which the delivery device is to be used. In particularly preferred embodiments, the material has a Shore hardness value of about 20 to about 60 on the Shore hardness scale A. For embodiments of the delivery device suitable for use in medical or paramedical applications, the material used will preferably also meet biocompatibility certification standards.

[0227] The material used to form the delivery device is preferably selected from the group consisting of: thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), polyvinyl alcohol (PVA or PVOH), silicone or silicone equivalents, and other bioplastics or other materials having substantially similar performance characteristics to any of these materials. However, as mentioned above, there are other materials suitable for forming the delivery device of the first aspect of the invention.

[0228] Also further disclosed is a delivery device 10 molded using a manufacturing mold 60 .

[0229] Also disclosed is a manufacturing jig 70 for assembling the delivery device 10 and the insertable article 20, such as Figures 23 to 34 The manufacturing jig 70 includes an insertable loading mechanism 80, which is suitable for loading the insertable 20 into the insertable orientation mechanism 11. Preferably, the insertable loading mechanism 80 includes:

[0230] a. a delivery device support member 81 adapted to support the delivery device 10 so that the delivery device 10 is oriented to receive the insertable object 20 loaded into the insertable object orientation mechanism 11; and

[0231] b. Insertable support member 82 adapted to support insertable 20 for loading the insertable into insertable orienting mechanism 11 .

[0232] In a preferred embodiment, the components of the jig 70 are in a generally single track-like arrangement. Preferably, the insertable support member 82 is located distally of the delivery device support member 81 .

[0233] In some preferred embodiments, insertable 20 has a longitudinal axis and a retrieval line 102 extending generally from insertable 20, and insertable support member 82 is adapted to support insertable 20 such that the insertable longitudinal axis is generally aligned with insertable orienting mechanism first longitudinal axis 51, wherein insertable proximal end 21 generally faces insertable orienting mechanism 11. In some such embodiments, the insertable is a tampon 100.

[0234] The manufacturing jig 70 (which is adapted to facilitate loading of the insertable 20 having the retrieval wire 21) also includes a retrieval wire pulling mechanism 71 having a longitudinal axis and adapted to engage with the proximal end 103 of the retrieval wire for pulling the retrieval wire through a passage formed in the base 12 or the partition 19 of the insertable orienting mechanism. The retrieval wire pulling mechanism 71 is mounted to the manufacturing jig 70 via a retrieval wire pulling mechanism support member 75.

[0235] The retrieval wire pull mechanism 71 includes a wire engagement mechanism 72 to which the proximal end 103 of the retrieval wire may be engaged. Preferably, the longitudinal axis of the retrieval wire pull mechanism 71 is configured to be generally aligned with the first longitudinal axis 51 of the insertable orienting mechanism.

[0236] The retrieval wire pulling mechanism 71 is also adapted to form a passage in the base 12 or the partition 19 of the insertable orienting mechanism. Some such embodiments provide that the retrieval wire pulling mechanism 71 further comprises a piercing mechanism 73 adjacent to the wire engaging mechanism 72. The piercing mechanism 73 is preferably a sharp member that is capable of penetrating the base 12 or the partition 19 of the orienting mechanism.

[0237] In the rail-like arrangement and in other arrangements, the retrieval wire pulling mechanism 71 is preferably located on the proximal side of the delivery device support member 81. In some preferred embodiments, the retrieval wire pulling mechanism 71 is adapted to be movable along the longitudinal axis of the retrieval wire pulling mechanism, and wherein, when the retrieval wire pulling mechanism 71 is advanced toward the delivery device support member 81, as shown in FIG. Fig.30 As shown, piercing mechanism 73 forms a passageway in base 12 or divider 19 of the insertable orienting mechanism and extends toward insertable support member 82 .

[0238] In a preferred embodiment, when the retrieval wire pulling mechanism 71 moves away from the insertable orienting mechanism 11, the retrieval wire pulling mechanism pulls the retrieval wire proximal end 103 through the channel in the base 12 or the partition 19 of the insertable orienting mechanism. Fig.32 Depicted in.

[0239] When the retrieval wire pulling mechanism 71 pulls the retrieval wire 102 back through the passage formed in the base member 12 or the partition 19 of the insertable object orienting mechanism, the insertable 20 passes through the insertable receiving aperture 76, as shown in FIG. Fig.28 As shown, the proximal end of the insertable is then preferably engaged with the insertable orientation mechanism 11, thereby loading the insertable 20 into the insertable orientation mechanism 11. In a preferred embodiment, and as shown Fig.33 As depicted, after insertable 20 is loaded into insertable orienting mechanism 11 , proximal end 103 of retrieval wire is disengaged from retrieval wire pulling mechanism 71 .

[0240] The manufacturing jig 70 also includes a retrieval wire placement mechanism 74 that is adapted to place a length of retrieval wire 102 that has been pulled through the passageway proximate the distal end of the finger orientation mechanism 13 .

[0241] In some preferred embodiments, a section of retrieval wire placed near the distal end of the finger orientation mechanism 13 is in a noodle-like configuration. Fig.34 Depicted as 102. Preferably, the retrieval line placement mechanism 74 includes an air source (not shown) adapted to blow a length of retrieval line to the vicinity of the distal end of the finger orientation mechanism 13.

[0242] Further disclosed is a method for manufacturing an assembly of a delivery device 10 and an insertable article 20, the method comprising:

[0243] a. Providing a manufacturing mold 60, an insert 20, a material for making the delivery device 10, and a manufacturing jig 70;

[0244] b. The manufacturing mold 60 is heated to a temperature capable of maintaining the material in a molten form, and the molten material is introduced into the manufacturing mold 60;

[0245] c. Cooling the manufacturing mold 60 so that the molten material solidifies to form the delivery device 10, and removing the mold 60;

[0246] d. loading the formed delivery device 10 and insertable 20 into manufacturing jig 70 ; and e. loading insertable 20 into insertable orienting mechanism 11 using manufacturing jig 70 .

[0247] Preferably, the step of introducing the molten material into the manufacturing mold 60 is performed under a pressure sufficient to allow the molten material to uniformly fill the mold 60 .

[0248] The manufacturing method further includes packaging the assembly of the delivery device 10 and the insertable 20. Preferably, the packaging is formed of a biodegradable material.

[0249] Furthermore, the delivery device 10 can be manufactured in a variety of ways. Preferably, the delivery device is manufactured as a low-cost item and made of a single material without seams during the simultaneous production of multiple delivery devices 10. Single-piece manufacturing requires that the mold 60 be manufactured to the appropriate shape and thickness in different areas of the final molded delivery device 10. By way of example only, the ends of the skirt member 44 with flexible structural strength, the insertable object orientation mechanism 11, and the finger orientation mechanism 13 may require a different thickness than the rest of the skirt member 45, which portions with flexible structural strength require flexibility and thinness to facilitate movement of the skirt member 40 about the inflection point, while other properties are consistent in thickness throughout the delivery device 10.

[0250] As described above, simple injection molding is a particularly preferred method of manufacturing the delivery device 10. However, some variations of injection molding that may be used include two-shot injection molding and injection molding with overmolding (injection). Although more complex and therefore more expensive, the delivery device 10 may also be manufactured using the following methods: injection dip molding, or injection blow molding, injection blow molding with extrusion blow molding, extrusion thermoforming, or forming and welding of a calendered elastic film. These are described in more detail below with respect to alternative embodiments of the manufacturing methods.

[0251] In some alternative embodiments of the manufacturing method, for example, the injection molding machine has at least two injectors, each with a different material or a different grade of material. In some such embodiments, the H-shaped longitudinal cross-sectional portion is manufactured using a selected thermoplastic having one softness grade, while the remainder of the delivery device 10 is manufactured by injection of a different grade of material (e.g., softness, color, additives) formed around the H-shaped longitudinal cross-sectional portion, and the different grades of material are substantially permanently bonded to the H-shaped longitudinal cross-sectional portion. This manufacturing method may require customized molding machinery and molds.

[0252] In some other alternative embodiments of the manufacturing method, for example, the H-shaped longitudinal cross-sectional portion is manufactured by injection molding using a selected thermoplastic having one softness grade. This cross-sectional portion of the delivery device 10 is then placed into another mold of the skirt member 40 for injection overmolding, wherein a material of a different grade (e.g., softness, color, additives) is injected around the first molded portion, and the different grades of material are substantially permanently bonded to the first molded portion.

[0253] In yet other alternative embodiments of the manufacturing method (e.g., injection blow molding), the profile of the H-shaped longitudinal cross-section portion is injection molded at the delivery end to have a spherical shape, thereby creating a "preform". The "preform" is then placed in a custom blow molding machine, where the spherical portion is heated to soften and the internal air pressure expands the spherical portion to fill the forming mold, which is then cooled and the delivery end is then cut off, creating an opening for inserting a delivery device. It is then inverted and ready for filling.

[0254] In some further alternative embodiments of the manufacturing method, for example, a profile of a portion of the delivery device 10, such as the skirt member 40, is made by dip molding in an injection molding machine. The profile of the H-shaped longitudinal cross-section portion is made as a sub-component in the injection molding machine, and then the sub-component is assembled into a dip molding mold. The dip molding mold is dipped into an elastic thermoplastic so that a portion of the injection molded part is dipped to form a bond when cooled. Preferably, the end of the dip molding is cut off to form an opening for inserting the delivery device 10. Subsequently, it is turned over and prepared for filling.

[0255] Other alternative embodiments of the manufacturing method provide, for example, that a profile of a portion of the delivery device 10, such as the H-shaped longitudinal section portion, is formed in an injection molding machine. A profile of another portion of the delivery device 10, such as the skirt member 40, is made by dip molding. The profile of the H-shaped longitudinal section portion and the profile of the skirt member 40 are assembled together. They are then turned over and prepared for filling.

[0256] In another alternative embodiment of the manufacturing method, for example, injection molding and extrusion blow molding are used. A profile of a portion of the delivery device 10 (e.g., the H-shaped longitudinal cross-section portion) is formed in an injection molding machine. A profile of another portion of the delivery device 10 (such as the skirt member 40) is made by extruding an elastic tube (e.g., an intermediate tube). The extrusion is preferably cut to length and heated, and then compressed air blows the polymer into a forming mold to produce a profile of the skirt member 40. The two profile portions are then assembled and inverted to prepare for filling.

[0257] Additional alternative embodiments of the manufacturing method employ injection molding and extrusion thermoforming. For example, injection molding is used to form a profile of a portion of the delivery device 10, such as the H-shaped longitudinal cross-sectional portion. The profile of another portion of the delivery device 10, such as the skirt member 40, is made by extruding an elastic tube (e.g., an intermediate tube). The extrusion is preferably cut to length, heated, and formed by inserting a forming mandrel to form the profile of the skirt member 40. The two profile portions are then assembled and inverted in preparation for filling.

[0258] In yet other alternative embodiments of the manufacturing method, for example, a profile of a portion of the delivery device 10, such as the H-shaped longitudinal cross-section portion, is formed in an injection molding machine. A profile of another portion of the delivery device 10, such as the skirt member 40, is made by calendering an elastic sheet, such as a thin mat. The sheet is preferably punched to shape, heated and formed onto a forming mandrel to form the profile of the skirt member 40 and heat welded along the seam. The two profile portions are then assembled and inverted in preparation for filling.

[0259] Still other alternative embodiments of the manufacturing method provide a delivery device 10, preferably in a configuration 41 around an insertable object, and in some embodiments, the H-shaped longitudinal cross-sectional portion is also substantially inverted to be manufactured by digital manufacturing to extrusion print 3D object layers with a suitable material.

[0260] Also disclosed is an assembly of a delivery device 10 and an insertable 20 manufactured by the manufacturing method described above.

[0261] Example

[0262] The following exemplary description of the evolution of the delivery device of the present invention is now provided and is not intended to be limiting.

[0263] Example 1

[0264] Early designs of suitable mechanisms for deploying an insertable into an orifice identified a number of improvements that would result in a desired, improved delivery device.

[0265] Development work initially focused on producing a device with multiple features, each with different and sometimes conflicting physical requirements. Early design and production trials were able to achieve these different requirements in a single product by using different materials and manufacturing methods for each component with its own set of features. These components were then combined into a single (multi-piece) assembly. However, it was found that this manufacturing method was complex and could be expensive to produce a viable device. It was also found that it was difficult to maintain strict quality control using this manufacturing method.

[0266] Example 2

[0267] Subsequent approaches resulted in the redesign of the device into a single mold, preferably maintaining the desired functionality and enabling simpler assembly. The injection molding approach was selected for multiple design and production trials according to this Example 2, with the goal of molding an approved medical grade elastomeric polymer in a one-piece design. Injection molding was considered ideal for producing large quantities of identical finished devices, but initially resulted in limitations associated with maintaining sufficiently thin wall portions for use in a sheath member adapted to expose the insertable 20 in preparation for insertion into the orifice. Identifying the appropriate material became an important part of the challenge faced in producing the deliverable device 10.

[0268] Multiple design and production trials in this Example 2 confirmed that obtaining a thin wall portion produced an incomplete molded part, while a thicker wall portion compromised effective inversion and the user's ability to obtain sufficient proprioceptive and tactile cues to guide the deployment of insertable object 20 into the orifice through fingers 30 and to determine the correct placement of the insertable within the orifice.

[0269] Example 3

[0270] Another approach subsequently employed was to mold the core socket features, such as the H-shaped longitudinal section, with injection molding, and to extrude and then heat deform the sheath member (which was adapted to be movable between a configuration around the insertable and a configuration around the finger), and to bond the two elements together in an automated process. Again, multiple design and production trials were conducted according to this approach employed in Example 3. However, the elastomeric material used for the sheath member could not withstand all of the process steps being performed and failed. Identifying the appropriate material remains a significant challenge.

[0271] Example 4

[0272] The design and production trials in Examples 1 to 3 also included a molded top seal that enabled the insertable 20 to be hygienically contained between the insertable orientation mechanism 11 and the molded top seal and surrounded by a portion of the sheath member. The molded top seal adds complexity to the material selection and manufacturing process.

[0273] Therefore, the subsequent approach taken was to forgo including a molded top seal and instead rely on the packaging to provide an effective seal to retain the insertable 20 in the insertable orienting mechanism 11. Animated digital simulations were used to simulate the new open top design taking into account the qualities of the different materials.

[0274] The design and production trials in this Example 4 also attempted to employ variations of the method of inverting the sheath member, with the goal of improving the performance of the sheath member as it moves between the configuration surrounding the deployed object and the configuration surrounding the finger. In some of these designs, the finger orientation mechanism is adapted to push through the middle of the sheath member, rather than causing the sheath member to be pulled downward to expose the insertable 20. However, the structural changes to the delivery device that employ this method result in unsatisfactory inversion performance. In other of these designs, a new position for the inversion initiator role (sheath member with a new shape and thickness profile) is employed.

[0275] Identifying the proper relative positions of the moving parts of a delivery device presents challenges such as friction between portions of the overlapping moving sheath member during inversion or reversal.

[0276] Example 5

[0277] Several materials tested were found to exhibit strong "stick" properties when the folded and overlapping portions slid over each other. A lubricant formulation (such as a medical grade lubricant) was applied to the surfaces of the sheath members manufactured in the design and production trials of this Example 5, which would slide over each other during inversion or reversal. While this does improve the ability of these surfaces to slide over each other, it creates an undesirable level of complexity because it may prove difficult (or even impossible) to keep the lubricant formulation on the relevant surfaces of the device when packaged, and the addition of the lubricant formulation to the delivery device 10 creates additional manufacturing steps and may introduce additional manual steps for the user.

[0278] It will be appreciated by those skilled in the art that many changes and / or modifications may be made to the invention shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. Therefore, the present embodiments are to be considered in all aspects as illustrative and not restrictive.

[0279] It should be noted that throughout the description and claims of this specification, the word "comprise" and variations of the word (such as "comprising" and "comprises") are not intended to exclude other variations or additional components, integers or steps. Modifications and improvements to the present invention will be obvious to those skilled in the art. Such modifications and improvements are intended to be within the scope of the present invention.

Claims

1. A delivery device for deploying an insertable object into an orifice guided by a finger, the delivery device comprising: an insertable orienting mechanism having a first longitudinal axis and a base, the insertable orienting mechanism being adapted to load an insertable and position the insertable in a deployed orientation, and a skirt member extending from adjacent the insertable object orienting mechanism and having a skirt length and including opposing finger contacting surfaces and an orifice contacting surface, wherein the skirt member is adapted to be generally parallel to the first longitudinal axis and movable along the skirt length between the following configurations: a configuration surrounding an insertable wherein the aperture contacting segment of the aperture contacting surface generally faces the insertable orienting mechanism and any loaded insertable; and A finger-encircling configuration wherein an aperture-contacting segment of the aperture-contacting surface faces generally away from the insertable orienting mechanism and any loaded insertable.

2. The delivery device according to claim 1, wherein: When the skirt member is moved along the length of the skirt from the configuration surrounding the insertable object toward the configuration surrounding the finger, the first portion of the skirt member is suitable for forming a finger orienting mechanism, which is suitable for positioning at least a portion of at least one finger in a navigation orientation, and the navigation orientation is suitable for guiding the deployment of the insertable object into the orifice.

3. The delivery device according to claim 1 or 2, wherein: Movement of the skirt member along the skirt length from the configuration surrounding the insertable object toward the configuration surrounding the finger accordingly causes the finger contacting segment of the finger contacting surface to face or contact at least a portion of at least one finger when the finger is surrounded by the skirt member.

4. The delivery device according to any one of claims 1 to 3, wherein: Movement of the skirt member along the length of the skirt from the configuration surrounding the insertable object toward the configuration surrounding the finger correspondingly causes a first portion of the contact orifice segment of the surface of the contact orifice to face or contact a second portion of the contact orifice segment of the surface of the contact orifice.

5. The delivery device according to any one of claims 1 to 4, wherein: When the skirt member is in the finger-wrapping configuration, substantially all of the finger-contacting segments of the finger-contacting surface face or contact at least a portion of at least one finger when the finger is surrounded by the skirt member, and substantially all of the orifice-contacting segments of the orifice-contacting surface are able to face or contact the inner side of the orifice.

6. The delivery device according to any one of claims 1 to 5, wherein: When the skirt member is in the finger-wrapped configuration, the portion of the insertable object orienting mechanism facing the orifice can face and contact the inner side of the orifice, and any loaded insertable can face and contact the inner side of the orifice.

7. The delivery device according to any one of claims 1 to 6, wherein: Movement of the skirt member along the length of the skirt from the configuration surrounding the finger toward the configuration surrounding the insertable object correspondingly causes a first portion of the contact orifice segment of the surface of the contact orifice to face or contact a second portion of the contact orifice segment of the surface of the contact orifice.

8. The delivery device according to any one of claims 1 to 7, wherein: Movement of the skirt member along the length of the skirt from the finger-wrapping configuration toward the insertable-wrapping configuration causes the finger-contacting segment of the finger-contacting surface to move away from, or out of contact with, at least a portion of any finger located in the finger orientation mechanism.

9. The delivery device according to any one of claims 1 to 8, wherein: When the skirt member is in the configuration surrounding the insertable, substantially all of the contact orifice segment of the surface of the contact orifice faces and is capable of contacting the portion of the insertable orienting mechanism facing the orifice and any loaded insertable for deployment, and substantially all of the contact finger segment of the surface of the contact finger faces away from the insertable orienting mechanism and any loaded insertable for deployment.

10. The delivery device according to any one of claims 1 to 9, wherein: After the insertable is deployed into the aperture, the skirt member is movable from the finger-surrounding configuration toward, but not to, the insertable-surrounding configuration to be in a disposable configuration.

11. The delivery device of claim 10, wherein: When the delivery device is in the disposable configuration, at least some of the contents within any orifice that are withdrawn when the delivery device is withdrawn from the orifice can be substantially contained between overlapping portions of the orifice-contacting surface, on portions of the orifice-contacting surface facing the insertable orienting mechanism, and / or in and around the insertable orienting mechanism.

12. The delivery device according to claim 10 or 11, wherein: When in the disposable configuration, the mutually overlapping portions of the aperture contacting surface and other portions of the aperture contacting surface generally concentrically surround the finger orientation mechanism and the insertable object orientation mechanism.

13. The delivery device of claim 12, wherein: The generally concentrically arranged portions have a length of about one eighth to about one half of the length of the delivery device in the finger-encircling configuration.

14. The delivery device according to any one of claims 1 to 13, wherein: The delivery device also includes at least one lubrication mechanism along, associated with, or applied to at least a portion of the skirt length, the lubrication mechanism being adapted to facilitate movement of the skirt member along the skirt length between the encircling insertable configuration and the encircling finger configuration.

15. The delivery device of claim 14, wherein each lubricating mechanism is selected from the group consisting of: an indentation formed in the wall of the skirt member, a kink formed in the wall of the skirt member, a pattern of projections, a pattern of depressions, or a pattern of projections and depressions formed on the wall of the skirt member, and a lubricating composition applied to a portion of the surface that contacts the orifice.

16. The delivery device according to claim 14 or 15, wherein: At least one lubrication mechanism is an indentation formed in the wall of the skirt member, and the indentation includes a series of parallel ridges, which are suitable for enabling movement of the skirt member along the length of the skirt to be achieved by generally rotational movement of the end of the skirt member in a helical direction along the parallel ridges.

17. A delivery device according to any one of claims 14 to 16, wherein: At least one lubrication mechanism is a kink formed in the wall of the skirt member, and the kink is generally S-shaped in longitudinal cross-section, thereby creating concave and convex inflection points, and the kink is suitable for enabling the skirt member to move along the length of the skirt across the concave and convex inflection points.

18. A delivery device according to any one of claims 14 to 17, wherein At least one lubrication mechanism includes a pattern of projections, recesses, or both formed on the wall of the skirt member, the pattern being formed at an angle so that, when portions of the skirt length overlap, the projections and recesses on corresponding cross-angle patterns are substantially prevented from interengaging.

19. A delivery device according to any one of claims 14 to 17, wherein: At least one lubrication mechanism includes a pattern of projections, a pattern of depressions, or a pattern of projections and depressions formed on a wall of the skirt member, and the pattern is irregular.

20. The delivery device of claim 18 or 19, wherein: The pattern is selected from the group consisting of a cross-hatched pattern, a spiral pattern, a honeycomb pattern, a pattern including a plurality of approximately hemispherical dimples distributed in parallel or in a hexagonal arrangement, and a corrugated pattern.

21. A delivery device according to any one of claims 14 to 20, wherein: At least one lubrication mechanism includes a lubricating composition applied to at least a portion of the surface contacting the aperture, the lubricating composition selected from the group consisting of one or more of: mineral oils, synthetic oils, solid lubricants, aqueous lubricants, and biolubricants.

22. The delivery device according to any one of claims 1 to 21, wherein The base of the insertable orienting mechanism forms a bottom portion of a generally U-shaped longitudinal cross-section of the insertable orienting mechanism.

23. The delivery device according to any one of claims 1 to 22, wherein: When the first portion of the skirt member forms the finger orientation mechanism, the longitudinal cross-section of both the insertable object orientation mechanism and the portion of the skirt member forming the finger orientation mechanism has a generally H-shaped shape.

24. The delivery device according to any one of claims 1 to 23, wherein: The base of the insertable object orientation mechanism includes a divider adapted to separate an insertable oriented for deployment from a finger positioned in the finger orientation mechanism.

25. The delivery device according to any one of claims 1 to 24, wherein: The insertable object orienting mechanism has a generally circular cross-section.

26. The delivery device according to any one of claims 1 to 25, wherein: The finger pointing mechanism has a generally circular cross-section.

27. The delivery device of any one of claims 1 to 26, further comprising an insertable ejection mechanism adapted to facilitate ejection of the insertable from the insertable orienting mechanism.

28. The delivery device of claim 27, wherein: The insertable object ejection mechanism is positioned adjacent a distal portion of at least one finger positioned in the finger orientation mechanism.

29. The delivery device of claim 27 or 28, wherein: The insertable object ejection mechanism is positioned on the underside of the base of the insertable object orienting mechanism.

30. The delivery device according to any one of claims 27 to 29, wherein The insertable object ejection mechanism is a depressible member that can be depressed by a distal portion of at least one finger positioned in the finger orientation mechanism to cause the proximal end of the insertable to be ejected from the insertable orientation mechanism.

31. A delivery device according to any one of claims 27 to 30, wherein: A portion of the finger orientation mechanism adjacent the insertable object ejection mechanism is configured to receive a distal segment of a nail.

32. The delivery device according to any one of claims 1 to 31, wherein The skirt member further includes an insertable component receiving mechanism adapted to receive the insertable component.

33. The delivery device of claim 32, wherein: The insertable component receiving mechanism is selected from the group consisting of: a skirt member width channel between an opening on the finger contact surface and an opening on the orifice contact surface, and a skirt member width slit-type channel opening at a distal end of the skirt member and extending along at least a portion of the skirt length.

34. The delivery device of claim 32 or 33, wherein: The insertable component receiving mechanism is adapted to receive at least a portion of a retrieval line connected to or integrally formed with the insertable.

35. The delivery device of claim 34, wherein: The retrieval string is the retrieval string of the tampon.

36. The delivery device according to any one of claims 1 to 35, wherein The distal end of the skirt member is thickened relative to the remainder of the skirt member, and the thickened end is about 0.1% to about 10.0% thicker than the remainder of the skirt member.

37. The delivery device of claim 36, wherein: The thickened end portion is adapted to facilitate movement of the skirt member along the length of the skirt between the around-the-insertable configuration and the around-the-finger configuration.

38. The delivery device of any one of claims 1 to 37, wherein: The base portion of the insertable object orienting mechanism also includes an insertable engagement mechanism adapted to engage at least a proximal end of the insertable.

39. The delivery device of claim 38, wherein: The insertable engagement mechanism is sized and shaped such that the proximal end of the insertable is compressively retained within the base of the insertable orienting mechanism.

40. The delivery device according to any one of claims 1 to 39, wherein The finger orientation mechanism also includes a portion adapted to snugly retain a portion of at least one finger in the navigation orientation.

41. The delivery device according to any one of claims 1 to 40, wherein The navigation orientation is such that, in the navigation orientation, a portion of at least one finger is oriented to apply at least one directional force to the insertable in the deployment orientation to deploy the insertable through a physical structure defining the aperture.

42. The delivery device of any one of claims 1 to 41, wherein: The deployment orientation has a longitudinal axis and the navigation orientation has a longitudinal axis, and the deployment orientation and the navigation orientation are arranged so that the longitudinal axis of the deployment orientation and the longitudinal axis of the navigation orientation are generally parallel to each other, generally aligned with each other, or intersect at an angle suitable for facilitating deployment of the insertable into the orifice.

43. A delivery device according to any one of claims 24 to 42, adapted so that advancement of the insertable object through the physical structure defining the orifice can transmit proprioceptive and tactile cues to a portion of at least one finger through the partition, thereby enabling informed selection of one or more directional forces necessary to guide the insertable object through the physical structure defining the orifice and / or into the orifice.

44. The delivery device of any one of claims 1 to 43, wherein: The insertable is selected from the group consisting of tampons, pessaries, suppositories, enemas, delivery devices for delivering liquids, creams and / or lubricants, tablets, capsules, caplets, screening devices, wipe devices, and any other device desired to be deployed into an orifice.

45. A method for finger-guided deployment of an insertable into an orifice, the method comprising: a. Providing a delivery device according to any one of claims 1 to 44, wherein the insertable is loaded in the insertable orienting mechanism and is positioned in a deployed orientation; b. If the skirt member: i. in the configuration surrounding the insertable, advancing a portion of at least one finger against an underside of the base of the insertable orienting mechanism so that the first portion of the skirt member forms a finger orienting mechanism adapted to position at least a portion of the at least one finger in a navigation orientation adapted to guide deployment of the insertable into the orifice; or ii. being between the configuration surrounding the insertable object and the configuration surrounding the finger or in the configuration surrounding the finger, advancing a portion of at least one finger into the finger orientation mechanism so that the finger is in the navigation orientation; c. if not already in the configuration around the finger, deforming the skirt member into the configuration around the finger, thereby exposing the insertable object; d. using said at least one finger pair to guide the deployment of said insertable object into said orifice; and e. Withdrawing the delivery device, leaving the insertable deployed in the orifice.

46. ​​The method of claim 45, wherein: After withdrawing the delivery device, the method further includes moving the skirt member from the finger-wrapping configuration toward but not reaching the insertable-wrapping configuration, wherein at least some of the contents within any orifice withdrawn from the orifice are substantially contained between overlapping portions of the orifice-contacting surface, on portions of the orifice-contacting surface facing the insertable orienting mechanism, and / or in and around the insertable orienting mechanism.

47. The method according to claim 45 or 46, wherein: After withdrawing the delivery device, the finger is withdrawn from the finger orienting mechanism.

48. A method according to any one of claims 45 to 47, wherein: The insertable is a tampon with a retrieval string extending from a proximal end of the tampon, and the orifice is a vaginal orifice, and wherein the step of withdrawing the delivery device includes allowing the retrieval string to pass through a passage formed in a base of the insertable orienting mechanism and out a distal end of the finger orienting mechanism, thereby causing the retrieval string to extend or hang from the vaginal orifice.

49. A manufacturing mould suitable for moulding a delivery device according to any one of claims 1 to 44.

50. The manufacturing mold of claim 49, comprising at least one core plate and at least one corresponding cavity plate.

51. The manufacturing mold of claim 49 or 50, further comprising at least two gates adapted to receive material in molten form to fill the mold cavity to mold the delivery device.

52. The manufacturing mold according to claim 51, wherein: At least three gates are selectively positioned generally circumferentially and distributed generally equidistantly about the skirt member and are spaced a predetermined distance relative to where the skirt member extends from the insertable orienting mechanism.

53. The manufacturing mold according to claim 52, wherein: The predetermined distance for selectively positioning the at least three gates is determined by reference to a position of the delivery device to be molded between the configuration surrounding the insertable and the configuration surrounding the finger when the mold is set up to mold the delivery device.

54. The manufacturing mold of claim 52, wherein: If the skirt member of the delivery device to be molded is in the surrounding insertable configuration when the mold is configured to mold the delivery device, the predetermined distance is about 0.1% to about 5% of the length of the skirt.

55. The manufacturing mold of claim 52, wherein: If the mold is configured to mold the delivery device with the skirt member of the delivery device to be molded approximately midway between the around insertable configuration and the around finger configuration, the predetermined distance is about 5% to about 25% of the skirt length.

56. The manufacturing mold of claim 52, wherein: If the skirt member of the delivery device to be molded is in the finger-encircling configuration when the mold is configured to mold the delivery device, the predetermined distance is about 95% to about 95.9% of the length of the skirt.

57. The manufacturing mold of claim 52, wherein: The at least three gates are selectively positioned adjacent an end of the skirt member.

58. A manufacturing mould according to any one of claims 52 to 57, adapted to mould the delivery device from a material suitable for the application to which the delivery device is to be applied.

59. The manufacturing mold according to claim 58, wherein: At least after molding, the material has a Shore hardness value of about 20 to about 60 on the Shore hardness scale A.

60. A manufacturing mold according to claim 58 or 59, wherein: The delivery device is to be used in medical or paramedical applications and the materials meet biocompatibility certification standards.

61. A manufacturing mould according to any one of claims 58 to 60, wherein: The material is selected from the group consisting of thermoplastic elastomers (TPE), thermoplastic polyurethanes (TPU), polyvinyl alcohol (PVA or PVOH), silicone or silicone equivalents, and other bioplastics or other materials having performance characteristics substantially similar to any of these materials.

62. A delivery device moulded using a manufacturing mould according to any one of claims 49 to 61.

63. A manufacturing jig for assembling a delivery device according to any one of claims 1 to 44 and an insertable according to claim 44, the manufacturing jig comprising an insertable loading mechanism adapted to load the insertable into the insertable orienting mechanism.

64. The manufacturing jig according to claim 63, wherein: The insertable object loading mechanism comprises: a. a delivery device support member adapted to support the delivery device so that the delivery device is oriented to receive the insertable object loaded into the insertable object orientation mechanism; and b. An insertable support member adapted to support the insertable for loading the insertable into the insertable orienting mechanism.

65. The manufacturing jig according to claim 63 or 64, wherein: The insertable support member is located on the distal side of the delivery device support member.

66. A manufacturing jig according to any one of claims 63 to 65, wherein: The insertable is a tampon having a longitudinal axis and a retrieval line extending generally from a proximal end of the tampon, and the insertable support member is adapted to support the tampon so that the longitudinal axis of the tampon is generally aligned with a first longitudinal axis of the insertable orienting mechanism and the proximal end of the tampon generally faces the insertable orienting mechanism.

67. The manufacturing jig of claim 66, further comprising a retrieval wire pulling mechanism having a longitudinal axis and adapted to engage a proximal end of a retrieval wire for pulling the retrieval wire through a passage formed in a base of the insertable orienting mechanism.

68. The manufacturing jig according to claim 67, wherein: The retrieval wire pulling mechanism includes a wire engaging mechanism to which the proximal end of the retrieval wire is engageable.

69. The manufacturing jig according to claim 66 or 67, wherein: The longitudinal axis of the retrieval wire pull mechanism is configured to be generally aligned with the first longitudinal axis of the insertable orienting mechanism.

70. A manufacturing jig according to any one of claims 66 to 69, wherein: The retrieval wire pulling mechanism is further adapted to form the passageway in the base of the insertable orienting mechanism.

71. The manufacturing jig according to claim 70, wherein: The retrieval wire pulling mechanism also includes a piercing mechanism adjacent to the wire engaging mechanism.

72. A manufacturing jig according to any one of claims 66 to 71, wherein: The retrieval wire pulling mechanism is located on the proximal side of the delivery device support member.

73. The manufacturing jig according to claim 72, wherein: The retrieval wire pull mechanism is adapted to be movable along a longitudinal axis of the retrieval wire pull mechanism, and wherein the piercing mechanism forms the passageway in the base of the insertable orienting mechanism and extends toward the insertable support member when the retrieval wire pull mechanism is advanced toward the delivery device support mechanism.

74. The manufacturing jig according to claim 73, wherein: The proximal end of the retrieval line is also engaged with the hook of the retrieval line pulling mechanism.

75. The manufacturing jig according to claim 74, wherein: The retrieval wire pulling mechanism pulls the proximal end of the retrieval wire through the passageway in the base of the insertable orienting mechanism as the retrieval wire pulling mechanism moves away from the insertable orienting mechanism.

76. The manufacturing jig according to claim 75, wherein: As the retrieval wire pulling mechanism is advanced further away from the insertable orienting mechanism, the proximal end of the tampon engages the insertable orienting mechanism, thereby loading the tampon into the insertable orienting mechanism.

77. The manufacturing jig according to claim 76, wherein: The proximal end of the retrieval wire is disengaged from the wire engagement mechanism.

78. A manufacturing jig according to any one of claims 66 to 77, further comprising a retrieval wire placement mechanism adapted to place a length of retrieval wire that has been pulled through the passageway proximate a distal end of the finger orientation mechanism.

79. The manufacturing jig according to claim 78, wherein: The length of retrieval wire positioned adjacent the distal end of the finger orientation mechanism is in a noodle-like configuration.

80. The manufacturing jig according to claim 78 or 79, wherein: The retrieval wire placement mechanism includes an air source adapted to blow the length of retrieval wire proximate a distal end of the finger orientation mechanism.

81. A method of manufacturing a delivery device and an insertable assembly, the method comprising: a. Providing a manufacturing mold according to any one of claims 49 to 61, an insert according to claim 44, a material according to any one of claims 58 to 61, and a manufacturing jig according to any one of claims 63 to 80; b. heating the manufacturing mold to a temperature capable of maintaining the material in a molten form, and introducing the molten material into the manufacturing mold; c. cooling the manufacturing mold so that the molten material solidifies to form the delivery device, and removing the mold; d. loading the formed delivery device and the insert into the manufacturing jig; and e. Loading the insertable into the insertable orienting mechanism using the manufacturing jig.

82. The manufacturing method of claim 81, wherein the step of introducing molten material into the manufacturing mold is performed under a pressure sufficient to cause the molten material to uniformly fill the mold.

83. The method of manufacturing according to claim 81 or 82, further comprising packaging the delivery device and insertable assembly.

84. The manufacturing method according to claim 82, wherein the packaging material used for packaging is formed of a biodegradable material.

85. An assembly of a delivery device and an insertable manufactured by the manufacturing method of any one of claims 81 to 83.

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