GB2590900A

GB2590900A - Devices for insertion into a vaginal or rectal cavity

Info

Publication number: GB2590900A
Application number: GB1918508.1A
Authority: GB
Inventors: Sing Hooi Yu; Vo-Ta Vinh-Thang; Khan Akeel; Radziwon Ewa
Original assignee: Calla Lily Personal Care Ltd
Current assignee: Calla Lily Personal Care Ltd
Priority date: 2019-12-16
Filing date: 2019-12-16
Publication date: 2021-07-14
Also published as: GB201918508D0

Abstract

A tool for use in the manufacture of a device for insertion into a vaginal or rectal cavity comprises a shaft and a hook portion 14 having a curved internal surface configured to retain at least part of a cord 58 of the device during assembly and manufacture. The device may be a drug or hormone delivery device, a sample collector or a tampon sanitary product comprising a plug 52 configured to be worn inside the cavity attached to an externally wearable anchor such as an absorbent pad via a sheath 56 configured to receive a user’s finger for insertion of the device and having a cord 58 or string attached to the plug for removal. The hook has a sharp piercing end and is extended trough a hollow mandrel 30 to pierce the sheath 56 over the mandrel and then retracted though the mandrel 30 to pull the cord 58 and attached plug 52 to abut the sheath 56 for subsequent attachment by heat sealing.

Description

Devices for insertion into a vaginal or rectal cavity This invention relates to a tool and method for manufacturing at least part of a device for insertion into a vaginal or rectal cavity. More specifically but not exclusively, the invention relates to a tool and use of the tool in a method of manufacturing at least part of a device for insertion into a vaginal or rectal cavity, such as a drug or hormone delivery device, sample collector or a sanitary product for use by women for the absorption of menstrual fluid and such like.

Background

Devices may be inserted into a vaginal or rectal cavity for several reasons. For example, during menstruation, women may choose to insert a tampon into a vaginal cavity to absorb menstrual fluid. Devices may also be inserted into a vaginal or rectal cavity in order to deliver drugs or hormones locally or systemically, or to collect samples from the body.

Statements of Invention

Some examples herein relate to a tool for use in the manufacture of a device for insertion into a vaginal or rectal cavity. For example, the device may be a sanitary product, for the absorption of menstrual fluid, or may be a device for drug or hormone delivery or collection of a sample from the cavity. In particular, presented herein is a method for manufacturing at least part of a device for insertion into a vaginal or rectal cavity. For example, the device may comprise a plug (for insertion into a cavity) attached to an externally wearable anchor element (to be worn outside the cavity when the device is in use, e.g. when the plug is worn inside the cavity), via a sheath. A cord is attached to part of the plug and is configured to aid in the removal of the plug from the cavity.

The cavity may be a vaginal cavity, and the device may be a sanitary product for the absorption of menstrual fluid. The cavity may be a vaginal or rectal cavity, and the device may be a drug delivery device. The drug or hormone delivery device may provide for the administration for an accurate amount of a drug or hormone to a targeted area. The target area for the drug or hormone may be behind the cervix for a vaginal drug or hormone, or past the sphincter for a rectal drug or hormone. In the case of a drug or hormone delivery device, the plug may comprise a pharmaceutically active composition. The cavity may be a vaginal or rectal cavity, and the plug may configured to absorb a sample from the body, such that the sample can be tested after removal from the body.

The plug may be an absorbent plug. The plug may comprise an absorbent material and may be configured to absorb fluid, such as menstrual or other bodily fluid. The plug may additionally or alternatively comprise a pharmaceutically active composition.

The externally wearable anchor element may prevent the inserted plug from moving within the cavity. The externally wearable anchor element may comprise an adhesive sheet to secure the anchor element to the wearer's underwear or clothing. The externally wearable anchor element may recover any fluid rejected by the cavity. The externally wearable anchor element may be an absorbent pad. The surface of the anchor element that faces the user may comprise an absorbent material. The surface of the anchor element that faces away from the user may comprise an impermeable material such that the user may grasp this outward face of the anchor element to cleanly remove the device.

The sheath may join the anchor element to the plug. The sheath may be configured to receive the plug. For example, in a stored configuration (e.g. when sold) the plug may be received, e.g. contained, in the sheath. The sheath may be configured to receive a user's finger such that, in use, the user can push the plug out of the sheath and into a vaginal or rectal cavity.

This process may cause the sheath to invert and the user's finger may be received in the sheath as the user's finger advances to further insert the plug into the vaginal or rectal cavity. The user may therefore be able to insert their finger into the sheath, e.g. from an outward side of the anchor element, to assist in the insertion of the plug into the cavity. After use, and during removal of the plug, the user may pull on the cord attached to the plug, which may extend through the sheath, and which will cause the plug to be removed from the cavity. Further pulling on the cord may cause the plug to be received in the sheath.

The sheath may comprise a sleeve, or tube, of material. The material may comprise a plastics material. The sheath may comprise a substantially cylindrical shape and/or may comprise a substantially circular cross section. The sheath may comprise a varying diameter along a length. The sheath may comprise a first end that is to be connected to part of the anchor element and/or the sheath may comprise a second end that is to be connected to part of the plug (for example, in the manufactured device where the anchor element and plug are connected via the sheath). The sheath may comprise a flexible material. The sheath may comprise a liquid impermeable material. For example, the sheath may comprise a liquid impermeable membrane. The sheath may be radially expandable. The sheath may be configured to receive a user's finger.

In order for the device to be used in the manner described above, the sheath must therefore be attached to the plug and the anchor element. According to some examples, there is provided a tool which is suitable for use in part of a manufacturing process to manufacture the device, in particular the tool is suitable to join at least part of the sheath of the device to at least part of the plug of the device, via the cord of the device.

The tool comprises a shaft and a hook portion that is configured to retain at least part of the cord of the device. The hook portion may comprise a surface configured to retain at least part of the cord of the device. The surface is curved. The curved surface of the hook portion that is configured to retain at least part of the cord of the device may be internal to the shaft (e.g. may comprise an internal protrusion) or may be external to the shaft (e.g. may comprise an external protrusion, e.g. an outwardly protruding curved arm). The curved surface of the hook portion may be formed at least in part from a recess in the shaft such that the curved surface comprises a curved internal surface. The curves surface may be located at a distal end of the shaft of the tool. The curved surface may have a center of curvature on, or about, the longitudinal axis of the shaft such that as an upward (referring to the tool in use as will be described below) force is exerted on the cord, the cord is pulled upwards and against the curved surface. Therefore, the curved surface in these examples may be referred to as an upward curved surface. The curved surface may be described as curving downwards. The curved surface may comprise a fillet, for example a curved fillet, for example an internal curved fillet (or, curved chamfer).

The plug may comprise what may be known as a tampon. The plug may comprise a substantially cylindrical plug. The cord may comprise a loop of string.

The tool may be substantially cylindrical and may comprise a substantially elongated body along a longitudinal axis. The shaft of the tool may comprise the body and, accordingly, the shaft may comprise a substantially cylindrical shape. The shaft may comprise substantially circular cross-sections and a shaft longitudinal axis. According to some examples herein, the cord may be placed in the hook portion so that the curved surface of the hook portion retains the cord. As will be described below, this may be performed as part of a method to attach at least part of the sheath to at least part of the plug. The loop may be formed from two strands of string knotted together, or may be formed by a single strand of string having its ends attached to the plug. Accordingly, the cord may comprise a knot. The tool may be substantially cylindrical.

Prior to the manufacture of the device, the protective sheath is configured for attachment to at least part of the plug. The protective sheath may be sized such that a wearer's finger can be received in the sheath to assist insertion of the tampon. In the context of this invention, internally worn may mean inside the vaginal or rectal cavity. In other words, it may mean inwardly of the cavity orifice. In the context of this invention, externally worn may mean outside the vaginal or rectal cavity. In other words, it may mean outwardly of the cavity orifice. If the device is for use in a vaginal cavity, it may be preferred that the anchor element of the invention is worn in the vulva, e.g. between the labia majora.

The sheath may be referred to as a cover, sleeve, tube or neck of material. The material may be a plastics material. The sheath may comprise a substantially cylindrical shape and/or may comprise a substantially circular cross section. The sheath may comprise a varying diameter along a length. The sheath may comprise a first end that is to be connected to part of an anchor element and/or the sheath may comprise a second end that is to be connected to part of the plug (for example, in the manufactured device where the anchor element and plug are connected via the sheath). The sheath may be configured for joining to the anchor element such that the sheath opens through the anchor element so that a finger can be inserted into the sheath from the side of the anchor element that faces away from the body in use. The sheath may comprise a flexible material. The sheath may comprise a liquid impermeable material. For example, the sheath may comprise a liquid impermeable membrane. The sheath may be radially expandable. The sheath may be configured to receive a user's finger. The sheath may be configured to be joined to an end of the plug that is nearest to the cavity opening in use.

The tool according to some examples herein may be used in a manufacturing process to manufacture the device, prior to a step of joining at least part of the sheath to at least part of the plug. For this purpose, the tool comprises a hook portion configured to retain at least part of the cord in a curved surface thereof such that the plug (to which the cord is attached) is effectively anchored, or held in place, in such a way that it abuts the sheath of the device. The curved surface of the hook portion ensures a more uniform distribution of the tensile force when the tool is moved, which will cause the cord to be pulled when the hook retains the cord. For example, the curved surface may substantially eliminate point loads that may occur if the surface of the hook portion retaining the curved contained sharp edges. Thereafter, a separate process may heat seal part of the sheath to part of the plug. In other words, the tool may be suitable for bringing the sheath into abutment with the plug prior to a step of joining the sheath to the plug.

The tool may comprise a piercing element that is configured to pierce the sheath. By providing a piercing element on the tool, the process of manufacturing the device can be made more efficient, as the tool is able to perform the steps of piercing the sheath and hooking the cord onto the hook can be carried out with the same tool. In other words, the hook portion (hereafter will be synonymously referred to as the "hook") is configured to retain the cord of the plug and, as the tool is configured to pierce the sheath, the tool is configured to pierce the sheath with the cord. For example, when the hook of the tool retains the cord of the plug in the curved surface thereof, movement of the piercing element to pierce the sheath may cause the hook of the tool to protrude through the sheath, such that the cord (retained in the hook) moves from a first side of the sheath (the side on which it was dispend prior to piercing) to a second side of the sheath. Effectively, the tool is configured to urge the cord of the plug through a hole in the sheath. For this purpose, the piercing element may be located at a distal end of the shaft and the piercing element may comprise the hook. The hook may be located at the distal end of the shaft. In this way, the part of the tool that is configured to pierce the sheath comprises the hook. In other words, the hook of the tool is configured to pierce the sheath. As above, this can cause the cord of the plug, which is retained in the hook, to pass through an opening (formed by piercing) in the sheath, effectively joining the cord (and therefore the plug) to the sheath prior to a step of heat sealing the heath to the plug. The piercing element may be arranged to pierce the sheath during motion of the tool along the longitudinal axis of the shaft.

The piercing element is therefore movable, e.g. in a piercing direction, between a retracted configuration and an extended configuration, and wherein movement of the piercing element from the retracted configuration to the extended configuration may cause the sheath to be pierced. Additionally, the piercing element comprising the hook provides a compact arrangement of the tool which is able to pierce the sheath and hook the cord onto the hook.

By locating the hook at the distal end of the shaft, the hook may be easily accessible for a user to place the cord onto the hook.

In some examples, the hook may comprise a protrusion (e.g. an arm, or limb) extending away from the body of the shaft or inwardly to the body of the shaft. In some examples, the hook may be formed in a recess of the shaft. The hook may be formed in a cut-away portion of the shaft. The recess may extend at least partially in the circumferential direction of the shaft. The recess may comprise a cylindrical and/or a radial cutout in the shaft. In other words, the recess may comprise a circumferential recess and/or a radial recess. The recess may comprise a substantially arcuate, or semi-circular, recess. As stated above, the shaft of the tool may have a cylindrical shape. The shape of the recess may be approximately that of a quadrant of a cylinder. In other words, the recess may be formed by removing a cylinder quadrant from the shaft. In other words, the recess may comprise, or be formed by, a segmented cylindrical cutout.

By forming the hook in a recess of the shaft, the cord may be retained within the shaft, as opposed to being retained outside of the shaft by an outwardly protruding limb. The hook may retain the cord substantially along the longitudinal axis of the shaft. Forming the hook in a recess of the shaft may allow retraction of the shaft into a mandrel with a substantially constant cross section. In other words, a mandrel having a central opening may be dimensions to receive the shaft and therefore dimensioned to receive the hook.

The recess may comprise, e.g. may define, a first surface (or upper surface) at the distal end of the shaft and a second surface (or lower surface) at an opposite, or proximal, end of the shaft. The first surface may be the surface of the recess at a distal end of the recess (the distal end of the recess being the end of the recess proximate to the distal end of the shaft). The first surface of the recess may comprise the hook. The first surface of the recess may make an angle of approximately 45 degrees with the longitudinal axis of the shaft. In other words, the distal surface of the recess may be sloped so as to define a substantially angular cavity within the shaft. The recess may therefore comprise an angled cutout in the shaft, where the angle an upper surface of the recess, proximate the distal end of the shaft, comprises the hook and therefore makes an angle of 45 degrees with the shaft.

Accordingly, the second surface may be substantially opposite the first surface, and the recess may be at least partially defined by the space in the shaft between the first and second surfaces. The second surface may make an angle of approximately 40 degrees with the longitudinal axis of the shaft. The second surface may be substantially parallel with the first surface. The first and second surfaces may be straight surfaces.

The recess may comprise a third surface, wherein at least part of the third surface is being parallel to the longitudinal axis of the shaft. The first and second surfaces may be disposed at opposite ends of the third surface. In other words, the recess may be defined by three surfaces, an upper surface proximate the distal end of the shaft, an opposing, lower, surface, and a third surface. The third surface may be a straight surface.

The curved surface, that is configured to retain the cord, may join the first and second surfaces.

In other words, the first surface and the second surface may be connected by the curved surface. The radius of curvature of the curved surface may be 0.2mm. A further curved surface may join the second and the third surfaces. In other words, the second and third surfaces may be connected by a further curved surface. The radius of curvature of the further curved surface may be 0.5mm.

The piercing element may comprise a piercing point, e.g. a needle-point or a needle, and the angle of a line extending from the outer diameter of the shaft to the piercing point may be approximately 40 degrees to the longitudinal axis of the shaft. The piercing point may be substantially cone shaped. The tool may be continuous, e. comprise a continuous profile, from the piercing point of the shaft to a distal end of the hook.

The shaft may comprise a first shaft portion of a first diameter, the first shaft portion comprising the distal portion. The shaft may comprise a second shaft portion of a second diameter, the second diameter being greater than the first. The shaft may comprise a frusto-conical portion disposed in between the first and second shaft portions, the frusto-conical portion having a first end of the first diameter and a second end of the second diameter. The frusto-conical portion may thereby smoothly join the first and second shaft portions. In other words the tool may comprise a continuous profile.

The angle that the curved surface of the frusto-conical portion makes with the longitudinal axis of the shaft may be approximately 15 degrees. The curved surface of the frusto-conical portion may be the outer surface of the frusto-conical portion.

The tool may further comprise a mandrel. The tool may be movable with respect to the mandrel. The tool may be movable between a stowed, or retracted, position in which the distal end of the tool is disposed within a body of the mandrel and a deployed, or extended, position in which the distal end of the tool is remote from the body of the mandrel. The mandrel may comprise an internal shaft into which the tool can be received. The piercing element may be in its retracted configuration when the tool is in its stowed position and be in its extended configuration when the tool is in its deployed position. The tool may be movable to and from a cord release position, partway between the stowed and deployed positions. The mandrel may comprise radiused edges, or curved edges, at an entry to the internal shaft, to prohibit damage to a cord retained on the tool. The cord-release position is therefore a position in-between the extreme positions of the tool within the mandrel (the deployed and stowed positions).

The tool may further comprise a foot pedal, and depression of the foot pedal may cause the tool to move from its stowed to its deployed position. Release of the foot pedal may cause the tool to move from the deployed position to the stowed position. Partial depression of the foot pedal may cause the tool to move from the stowed to the cord release position.

The mandrel may be sized such that the mandrel is receivable in the sheath of the device.

According to another example, there is disclosed a method of using the tool as described above to manufacture (part of) a device (at least part of which is suitable) for insertion into a vaginal or rectal cavity. The method comprises placing the cord of the device into the hook so that the cord is at least partially retained in the hook. The method may further comprise moving the tool from a stowed position to a retracted position, e.g. under the control of a foot petal, prior to placing the cord into the hook. The method may comprise loading the sheath of a device (e.g. as describe above) onto the mandrel. The method may comprise moving the tool from a stowed into a retracted position to pierce the sheath. This may be performed while the hook is retaining the cord such that piercing of the sheath moves the cord through a piercing in the sheath.

Brief Description of the Figures

Examples will now be described by way of example only, with reference to the Figures, in which: Figure 1 schematically shows a tool according to the invention; Figure 2 schematically shows a device for insertion into a vaginal or rectal cavity which may be manufactured using the tool of Figure 1; Figure 3A schematically shows an enlarged view of the tool of Figure 1; Figure 38 schematically shows an enlarged view of the tool of Figure 1 in a plane perpendicular to the plane of Figure 2; Figure 4 schematically shows the tool in use, in an extended position, with a sheath placed on the mandrel and the cord of a plug retained on the hook; Figure 5 schematically shows the tool of Figure 4 in a retracted position; and Figure 6 shows the steps of a method of using the tool of Figure 1.

Detailed Description

Figure 1 shows a tool 10 comprising an elongate shaft 12 and a hook portion 14 disposed at a distal end of the shaft 12. The shaft 12 is substantially cylindrical and, in this example, comprises regions of varying diameter, comprising a first region at a distal end, and a second region at a proximal end 18. In other examples however, the shaft may comprise non-varying diameter. The shaft comprises a shaft longitudinal axis A. Between the proximal end 18 and the distal end 16, the shaft 12 comprises a transition region 20 which is frusto-conical in shape and comprises a reducing diameter from the proximal end 18 to the distal end 16. The angle B that the frusto-conical surface of the transition region 20 makes with the longitudinal axis A, in this example, is substantially 15 degrees. The elongate shaft 12 defines a cylindrical coordinate system, comprising the longitudinal axis A, a radial direction R, perpendicular to the longitudinal axis A, and a circumferential, or azimuthal, direction O. Figure 2 shows an example device 50, in this example a sanitary product 50. The tool 10 shown in Figure 1 is suitable for use in the manufacture of the sanitary product 50. The sanitary product 50 comprises an internally wearable plug 52, in this example an absorbent plug 52, and an externally wearable anchor element 54, in this example an absorbent pad 54 joined to one another by a sheath 56. The sheath 56 opens through the pad 54 such that a wearer's finger can be received in the sheath 56 to assist insertion of the absorbent plug 52. A cord 58 is attached to the absorbent plug 52, to assist in removal of the absorbent plug 52 from the vaginal cavity. In this example, the cord 58 comprises two strands of string 60, 62 joined together by a knot 66 to form a loop 64 of material, although it will be appreciated that the loop 64 may be formed of a single strand of string having two ends attached to the absorbent plug 52.1t will also be appreciated that in other examples, the internally wearable plug 52 and/or externally wearable anchor element 54 may be non-absorbent.

Although the detailed description here describes a tool and method with reference to the manufacturing of a sanitary product for insertion into a vaginal cavity, it will be understood by the skilled person that the tool and method disclosed herein are also suitable for the manufacture of alternative devices which are suitable for insertion into a vaginal or rectal cavity, such as a drug or hormone delivery device or a body sample collection device.

The tool 10 may be used for retaining and/or piercing at least part of the sanitary product. For example, the sanitary product 50 may not comprise a cord 58 or sheath 56, but nevertheless the tool 10 may be configured to pierce and/or retain part of the sanitary product other than the cord or sheath. However, according to some examples presented herein, the tool 10 is configured to retain the cord 58, which is attached to the absorbent plug 52 of the sanitary product 50, and pierce the sheath 56 of the sanitary product, as will be described below.

Referring to Figures 3A and 3B, the hook portion 14 of the tool 10 comprises a piercing element 22 disposed on a distal end of the hook 14. The distal end of the hook is at the same end as the distal end of the shaft. For example, the distal end of the hook may comprise a terminal region of the shaft. The piercing element 22 comprises a substantially cone-shaped piercing point, which tapers towards the distal end of the hook 14. It will be appreciated that the tip of the piercing point 22 is configured to pierce another article (e.g. a sheath of the sanitary product as described above). For example, the piercing point 22 may comprise a needle, or needle-point. The piercing point comprises a substantially conical surface, and the angle C that the substantially conical surface of the piercing element 22 makes with the shaft longitudinal axis A is substantially 40° in this example. The piercing element 22 is arranged such that movement of the tool, in the direction of the longitudinal axis A towards the distal end 12 of the tool 10 (relative to a mandrel 30 in which the tool 10 can be located, not shown in Figure 1 but shown in Figures 4 and 5) will pierce a sheath (such as sheath 56) located proximate the distal end of the tool 10 (e.g., as will be described with reference to Figures 4 and 5, a sheath disposed over the mandrel 30).

As shown in Figure 3A, a recess 24 is formed in the shaft 12 of the tool 10 and extends into the body of the shaft 12 in the radial R and circumferential direction 0 of the shaft 12. The recess 24 is a substantially angular cutaway from the shaft comprising the hook 14. The recess 24 is bounded and defined by three surfaces: a first, upper, surface 26 formed in the distal end 16 of the shaft, a second, lower, surface 28, formed substantially opposite the first surface 26, and a third, side, surface 30 which connects the first and second surfaces 26, 28. The first surface 26 comprises the hook portion 13. In other words, the upper surface of the recess comprises the hook 14 of the tool 10. Accordingly, the first surface 26 is arranged at an angle D of substantially 45° to the longitudinal axis A. The second surface 28 is arranged to be at an angle E of substantially 40'to the longitudinal axis of the shaft 12. In some examples the angles D and E may be substantially the same but in other examples they may differ. The third surface 30 in this example extends in a direction substantially parallel to the longitudinal axis A. The hook portion 14 comprises a curved surface 80. The surface 80 is to retain a cord, such as cord 58, therein. The curvature of the surface may be such that the cord is not subject to stress that could cause the cord tearing or breaking when the tool is moved. The tool and hook portion 14 comprise a further curved surface 81. It will be appreciated that the curved surface 80 joins the first and third surfaces 26, 30, and the further curved surface 81 joins the second and third surfaces 28, 30.

The recess 24 extends radially into the shaft 12. In this example, the extent of the recess 24 in the radial direction R is slightly over half the diameter of the first region of the shaft. The recess 24 extends at least partially in a circumferential direction around the shaft 12, and in this example defines an opening of substantially 1800 in the circumferential direction B. In this way, the loop 64 of a cord 58 hooked over the first surface of the recess 24, having tension applied to it in a direction along the longitudinal axis A, will be retained substantially centrally along the longitudinal axis A of the shaft.

As shown in Figures 3A and 3B, the curved surface has a curvature in two dimensions. For example the curved surface 80 comprises curvature, having a centre of curvature in the recess (Figure 3A) and a curvature 32 having a center of curvature outside of the tool, at a distal end thereof. Similarly, the further curved surface 81 comprises curvature in two dimensions.

It will be appreciated that although the hook portion is depicted as having a curved surface that is curved in two dimension, a curved surface curved in one dimensions is within the scope of the claims. For example, even curvature in one dimension may ensure a reduction on the tensile stressed applied to the cord when the tool is moved (to be described later), with the reduction increasing with curvature in additional dimensions.

Figures 4 and 5 shows the tool 10 in use during a process to manufacture part of a sanitary product, for example part of the sanitary product shown in Figure 2. The tool 10 is located within a mandrel 30, e.g. within an opening thereof, and is movable relative to the mandrel 30 between a stowed position (shown in Figure 5), in which the distal end 16 of the tool 10 is disposed within a body of the mandrel 30, and a deployed position (shown in Figure 4), in which the distal end 16 extends out of the body of the mandrel 30. The tool 10 is movable between the stowed and deployed position in a direction substantially parallel to the longitudinal direction A of the shaft. A third position, located partway, or midway, between the stowed and deployed positions is a cord release position in which the cord 58 is removable from the hook 14 by a user. The cord is however removable from the hook at positions of the tool between the partway position and the deployed position (shown in Figure 4). The tool 10 may be movable between the stowed, deployed and cord release positions by the movement of a foot pedal (not shown).

The mandrel 30 has a cylindrical internal shaft, into which the tool 10 can be received. The diameter of the shaft may be approximately 3.5mm to accommodate a knot having a width of up to 2.8mm, however it will be appreciated that for larger knots, a greater internal shaft diameter may be required.

As will be described below with reference to Figure 6, in use, the sheath of a sanitary product is disposed over the mandrel 30 as is shown in Figure 5. The sheath may be attached to the absorbent pad 54 of the sanitary product. At this time the tool 10 may be in its stowed configuration. The tool 10 is then moved to its deployed configuration (shown in Figure 4) causing the piercing element of the tool to pierce the sheath. A cord of the absorbent plug of the sanitary product may then be placed into the tool such that the cord is retained by the hook.

The tool may then be moved back to its stowed configuration (shown in Figure 5) thereby bringing the absorbent plug into abutment with the sheath, at least temporarily joining the plug to the sheath (e.g. prior to the plug being heat-sealed to the sheath). Then, the tool may be moved back to its deployed position so that the user may un-hook the cord from the hook of the tool and remove the sanitary product -however the sanitary product is now part-assembled, in that the plug abuts the sheath and the cord of the plug extends through the sheath. In other words, the sanitary product is substantially in the configuration as shown in Figure 2 but without the sheath being sealed to the plug (this process occurring in a subsequent step).

Figure 6 shows a flowchart of an example method 100, which may comprise a method of manufacturing at least part of a sanitary product 50 using the tool 14 as described above, and which may comprise a method of piercing a sheath of a sanitary product to join a plug thereto.

In a first step 102, a substantially cylindrical sheath 56 is placed over the mandrel 30.

At step 104, an externally wearable absorbent pad 54 is then placed over the mandrel 30 through a hole located in the absorbent pad 54, and is moved to a lower end (a proximal end) of the mandrel 30.

At step 106, the sheath 56 is heat sealed to the externally wearable absorbent pad 54 at an underside of the absorbent pad 54 (i.e. at a proximal end of the mandrel 30).

At step 108, pressure is applied to the sheath 56 on the mandrel 30 to hold it in position, whilst a foot pedal is depressed in order to move the tool 10 from the stowed position to the deployed position. Movement of the tool 10 between the stowed position and the deployed position causes the sheath 56 to be pierced by the piercing element 22, so that at least the hook 14 travels through the sheath material 56 and extends beyond the sheath 56.

At step 110, a user places the loop 64 of a cord 58, attached to an absorbent plug 52, between the curved edges 32, 34, such that the cord 58 is received within the recess 24 and retained by the hook 14, e.g. retained by the curve surface thereof. Tension may therefore be applied to the cord 58 in a direction substantially along the longitudinal axis A of the shaft, such that the cord 58 is retained by the hook 14 (Figure 4).

At step 112, the pedal is released, which moves the tool 10 from the deployed position into the stowed position (Figure 5). Pressure may be applied through the mandrel 30 to pull the knot 66 into the internal shaft of the mandrel 30. In this example a force of 17-22N, in one example, 18N, may be applied to the cord 58 by the hook 14, for example by a linear drive unit applying a pressure of 3 bar.

Once the knot 66 has entered into the internal shaft of the mandrel 30, as shown in Figure 5, the force on the cord 58 is reduced to a maximum of 10N, e.g. by the linear drive unit applying a pressure of 1 bar. The force is reduced after the knot 66 enters the internal shaft of the mandrel 30 in order to minimise damage to the end of absorbent plug 52 and the cord 58. The applied force may keep the string taught and hold the absorbent plug 52 in place on top of the mandrel 30 (as shown in Figure 5) allowing the next step (step 114) of the process to take place. If the force is too high, the absorbent plug 52 may be damaged by spreading of the absorbent plug 52 onto the end of the mandrel 30, and the cord 58 may be stretched. The absorbent plug 52 attached to the cord 58 is thereby retained on a distal end of the mandrel 30 (Figure 5). In this example, the movement of the tool 10 from the deployed position to the stowed position takes place at a speed of at least 250mm/s. In other embodiments, the force applied to the cord 58 and the speed of the tool 10 may be different, and may be dependent upon the dimensions of the tool 10 and mandrel 30.

At step 114, a user moves the absorbent pad 54 towards the distal end of the mandrel 30 and over the absorbent plug 52. This action may remove the absorbent pad 54 and the sheath 56 313 from the mandrel 30, and invert the sheath 56 in the process.

At step 116, the tool 10 is moved from the stowed position to a cord release position, partway between the stowed and deployed positions. The force on the cord 58 is reduced On one example, reduced to 7N).

At step 118, the user unhooks the loop 64 of the cord 58 from within the recess 24, such that the sanitary product 50 can be moved to the next stage of manufacture, which may comprise the heat sealing of the absorbent plug 54 to the sheath 56.

While the present disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Various alternative examples are discussed through the detailed description. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS1 A tool for use in the manufacture of a device for insertion into a vaginal or rectal cavity, the device comprising a plug configured to be worn inside the cavity, and a cord configured to aid in the removal of the plug from the cavity, wherein the tool comprises: a shaft; and a hook portion, wherein the hook portion comprises a curved internal surface configured to retain at least part of the cord of the device.
2. A tool according to claim 1 wherein the hook portion is disposed at a distal end of the shaft.
3 A tool according to claim 1 or 2, wherein the device further comprises a protective sheath attached to at least part of the plug, and wherein the tool further comprises: a piercing element configured to pierce the sheath.
4. A tool according to any preceding claim, wherein the piercing element is located at a distal end of the shaft.
5. A tool according to any of claims 3 or 4, wherein the hook portion comprises the piercing element.
6. A tool according to any preceding claim, wherein the hook portion comprises a recess of the shaft.
7. A tool according to claim 6, wherein the recess extends at least partially in the circumferential direction of the shaft.
8. A tool according to claim 6 or 7, wherein the recess comprises a radial cutout in the shaft.
9 A tool according to any of claims 6-8, wherein the recess comprises a distal end and a proximal end, a first straight surface at the distal end of the shaft and a second straight surface at the proximal end of the shaft.
10. A tool according to claim 9, wherein the first straight surface of the recess makes an angle of approximately 45 degrees with a longitudinal axis of the shaft..
11. A tool according to claim 9 or 10, wherein the second straight surface of the recess makes an angle of approximately 40 degrees with a longitudinal axis of the shaft.
12. A tool according to any of claims 9-11, wherein the recess comprises a third surface, and wherein the recess is at least partially defined by the space in the shaft between the first, second and third surface.
13 A tool according to claim 12, wherein the curved surface joins the first surface to the third surface.
14. A tool according to claim 12 or 13, wherein the recess comprises a further curved surface, wherein the further curved surface joins the second surface to the third surface.
15. A tool according to any claim 14, wherein the further curved surface has a radius of curvature of 0.5mm
16. A tool according to any preceding claim wherein the curved surface has a radius of curvature of 0.2mm.
17. A tool according to any preceding claim, wherein the piercing element comprises a piercing point and wherein the angle of the portion of the shaft extending along the longitudinal axis of the shaft, to the piercing point is approximately 40 degrees to the longitudinal axis of the shaft.
18 A tool according to any preceding claim, wherein the shaft comprises a first shaft portion of a first diameter, the first shaft portion comprising the distal portion, and a second shaft portion of a second diameter, the second diameter being greater than the first, and a frusto-conical portion disposed in between the first and second shaft portions, the frusto-conical portion having a first end of the first diameter and a second end of the second diameter, the frusto-conical portion thereby smoothly joining the first and second shaft portions.
19. A tool according to claim 18, wherein the angle of the curved surface of the frusto-conical portion to the longitudinal axis of the shaft is approximately 15°.
20. A tool according to any of claims 1-19, wherein the tool further comprises a mandrel, and wherein the tool is movable with respect to the mandrel.
21. A tool according to claim 20, wherein the tool is movable between a stowed position in which the distal end of the tool is disposed within a body of the mandrel and a deployed position in which the distal end of the tool is remote from the body of the mandrel.
22. A tool according to claim 21, further comprising a foot pedal, wherein depression of the foot pedal causes the tool to move from its stowed to its deployed position.
23. A tool according to any of claims 20-22, wherein the mandrel is sized such that the mandrel is receivable in the sheath of the device.
24. A tool according to any preceding claim, wherein the plug of the device comprises an absorbent plug
25. A tool according to any preceding claim, wherein the device is a sanitary product for insertion into a vagina.
26. A method of using the tool according to any preceding claim to manufacture a device for insertion into a vaginal or rectal cavity, the method comprising: placing the cord of the device into the hook portion so that the cord is at least partially retained by the curved surface of the hook portion.