WO2021122487A1

WO2021122487A1 - Devices for insertion into a vaginal or rectal cavity

Info

Publication number: WO2021122487A1
Application number: PCT/EP2020/086050
Authority: WO
Inventors: Yu Sing Hooi; Vinh-Thang VO-TA; Ewa Radziwon
Original assignee: Calla Lily Personal Care Ltd
Priority date: 2019-12-16
Filing date: 2020-12-14
Publication date: 2021-06-24
Also published as: GB201918514D0

Abstract

A method for manufacturing a device for insertion into a vaginal or rectal cavity. The method comprises providing an anchor element to be worn outside the vaginal or rectal cavity when the device is in use and forming a line of weakness in the externally wearable anchor element such that the anchor element is disposed to fold about the line of weakness. Forming the line of weakness comprises imprinting the anchor element to form the line of weakness.

Description

Devices for insertion into a vaginal or rectal cavity

This invention relates to an apparatus 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 an apparatus and use of the apparatus in a method for 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 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. In these examples, the sheath is configured to receive the finger of a user such that, in use, the user can 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. A cord may be attached to part of the plug. The cord may be 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 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. When attached to a plug, the externally wearable anchor element may prevent the inserted plug from moving within the cavity.

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.

Some devices having an externally wearable anchor element or pad may be compressed during manufacture to predispose the anchor element to folding, e.g. so that the anchor element may be folded into a stored configuration in which the device is to be sold to a user. However, compressing the anchor element may create tensions in other areas of the anchor element that may cause some of the material forming the anchor element to move, which may affect the properties of the anchor element.

According to some examples, there is provided a method for use in a process to manufacture the device. Some examples relate to a method for creating a line of weakness in an externally- wearable anchor element of a device at least part of which is for insertion into a vaginal or rectal cavity. The line of weakness is such that the anchor element is disposed, or has a tendency to, or is biased to, fold about the line of weakness. For example, the line of weakness may be such that the anchor element is disposed to fold about the line of weakness when a user grasps a surface of the anchor element to remove the device (e.g. a surface of the anchor element facing away from the user in use). This disposition to fold about the line of weakness may reduce the likelihood of parts of the device (e.g. the plug, sheath, and/or a side of the anchor element facing toward the user in use) touching the user. This is particularly advantageous when parts of the device have absorbed menstrual fluid. Furthermore, the line of weakness may mean that as the plug is removed from the cavity the anchor element is predisposed to fold about the plug. In other words, the removal of the plug from the cavity may cause the anchor element to fold about the line of weakness.

According to these examples, a line of weakness is formed in the anchor element by an imprinting process to create the line of weakness about which the anchor element is disposed to fold. The forming of the line of weakness by imprinting may constitute part of a method to manufacture the device as described above (e.g. a device comprising a plug attached to an anchor element via the sheath). For example some of the methods described herein may take place after a manufacturing step of forming the anchor element and prior to a manufacturing step of welding at least part of the sheath to a portion of the anchor element. In other words, the methods described herein may be performed following manufacture of the anchor element (to be described below).

According to one example of the disclosure there is provided a method for manufacturing (at least part of) a device (at least a portion of which is suitable) for insertion into a vaginal or rectal cavity, the method comprising providing an anchor element to be worn outside the cavity when the device is in use, forming a line of weakness in the externally wearable anchor element such that the anchor element is disposed to fold about the line of weakness, wherein forming the line of weakness comprises imprinting the anchor element to form the line of weakness.

Forming the line of weakness in this way avoids folding or otherwise manipulating (e.g. by compression) the anchor element to create a point of weakness which may compromise some of the integrity of the inner material of the anchor element depending on the exact nature of the technique used. For example, manipulating the anchor element in this way may cause some of the inner material to migrate. Using imprints to form the line of weakness has the advantage that the internal structure of the anchor element remains substantially the same before, during, and after the process of forming the line of weakness and the integrity of the inner material of the anchor element is therefore not compromised and should not move during the imprinting process.

Herein, the term “imprinting” may be considered synonymous with the term “stamping” and is intended to comprise the impression of a pattern, or stamp, onto the surface of the article to be imprinted so that the surface is at least partially indented. For example, forming the line of weakness by imprinting may comprise stamping the anchor element, e.g. with a stamp or stamping device. Imprinting may comprise embossing or debossing. Imprinting may comprise at least partially perforating the anchor element, for example at least partially perforating the anchor element to form the line of weakness. Partial perforation of the anchor element may be a perforation through an outer layer of the anchor element, but not an intermediate and/or lower layer of the anchor element. In other words, a partial perforation may comprise a perforation in part of the depth of the pad and imprinting may comprise only partial perforation of the anchor element along the line of weakness. Partial perforation of the anchor element may therefore comprise a perforation which does not extend through the whole thickness of the anchor element. Partial perforation of the anchor element may comprise forming at least one partial perforation or blind hole, etc.

Following the imprinting process, therefore, at least part of the anchor element may be imprinted. The line of weakness may be at least partially formed by an imprinted portion of the anchor element. In other words, following the imprinting process, at least part of the anchor element may be indented. The line of weakness may be at least partially formed by the indented portion of the anchor element. The anchor element may comprise a thickness and the imprinting process may create imprinted, or indented, regions of the anchor element, the imprinted or indented regions of the anchor element being regions of a reduced thickness. The line of weakness may comprise a region of the anchor element, at least part of which comprises a reduced thickness relative to the remainder of the anchor element.

The line of weakness may comprise a partially perforated region of the anchor element. In this example, too, the line of weakness may comprise a region of the anchor element, at least part of which comprises a reduced thickness relative to the remainder of the anchor element (as the perforation may not pass through the whole thickness of the anchor element).

The anchor element may comprises an inward-facing surface and an outward-facing surface, the inward-facing surface intended to be face the user when the device is worn in use, and the outward-facing surface intended to face away from the user when the device is in use. The in-ward facing surface may comprise an absorbent material (for example to absorb any fluid either on the body. The outward-facing surface may comprise a liquid-impermeable material (for example so that this surface of the anchor element remains relatively clean, being the surface of the anchor element that the user will manipulate to remove the device). Forming the line of weakness may comprise imprinting the outward-facing surface of the anchor element. In this example the line of weakness is formed in the surface of the anchor element that the user grasps to remove the anchor element. However, in other examples, forming the line of weakness may comprise imprinting the inward-facing surface of the anchor element. In this example the line of weakness is formed in the surface of the anchor element that faces the user when the device is in use.

The method may further comprise providing a 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. The method may comprise attaching the imprinted anchor element to a sheath of the device.

The method may comprise actuating, by a controller, a stamping device to imprint the line of weakness into the anchor element. In these example, a stamping device, or imprinting device, under the control of the controller, may be actuated to automatically form the line of weakness into the anchor element. Therefore, at least part of the process to manufacture the device (e.g. manufacturing a line of weakness in an anchor element of the device) may be performed automatically. The stamping device may comprise an embossing or debossing device. The stamping device may be actuated, e.g. under the control of a controller, to apply a pressure to the anchor element to imprint or stamp the line of weakness into the anchor element. The stamping device may be actuated to apply a pressure of approximately 6 bar. In other words, the stamping device may be actuated to operate, at a pressure of approximately 6 bar, a cylinder configured to apply the pressure. For example, the stamping device may comprise a 6-bar cylinder actuatable to apply a pressure to the anchor element to imprint or stamp the line into the anchor element.

In these examples, the stamping device (or “stamp”) may comprise an imprint surface comprising at least one of an engraved, patterned, blocked, impressed, indented, and marked surface, the imprint surface being the portion of the stamping device to imprint the line of weakness in the anchor element. The imprint surface may therefore comprise a predetermined pattern, corresponding to the line of weakness that is to form the line of weakness in the anchor element when the stamping device is sued to form the line of weakness. The method may comprise causing, e.g. actuating, by a controller, the imprint surface of the stamping device to come into contact with the anchor element (e.g. an inward-facing or outward-facing surface thereof) to impart the pattern formed on the imprint surface into the anchor element to form the line of weakness in the anchor element.

The imprinting surface may comprise a pattern that corresponds to the line of weakness, in which case, when the imprinting surface is brought into contact with the anchor element, the entire line of weakness is imprinted into the anchor element. Alternatively, the imprinting surface may comprise a pattern that corresponds to a portion of the line of weakness, in which case, when the imprinting surface is brought into contact with the anchor element, the a portion of the line of weakness is imprinted into the anchor element, and the stamping device is then moved to a subsequent position for the imprinting surface to be brought into contact with a second region of the anchor element to print a subsequent portion of the line of weakness. In these examples, a controller may control the movement of the stamping device, e.g. movement of the imprinting surface to imprint, piece-wise, the line of weakness into the anchor element. The controller may cause the imprinting surface to move, and imprint the anchor element, according to instructions that describe the line of weakness to be formed in the anchor element.

The method may further comprise actuating, by a controller, the stamping device to imprint a pattern into the anchor element. In this example, the pattern in the imprint surface of the stamping device that corresponds to the line of weakness may be referred to as a first pattern and the imprint surface may additionally comprise a second pattern that does not correspond to the line of weakness. The second pattern may comprise a bespoke design or logo etc. so that, at the same time as forming the line of weakness, unique designs may be formed in a surface of the anchor element.

The method may comprise actuating, by a controller, a perforating device to cause imprinting of the anchor element by causing at least a portion of the part of the anchor element to be partially perforated to form the line of weakness in the anchor element. In these example, a perforating device, under the control of the controller, may be actuated to automatically form the line of weakness into the anchor element. Therefore, at least part of the process to manufacture the device (e.g. manufacturing a line of weakness in an anchor element of the device) may be performed automatically. In these examples, the perforating device may comprise a perforating needle that is movable into partially through, and back out of a material to form at least one partial perforation in the material. The perforating device may be actuated to form the perforated line in accordance with a set of instructions that control the movement of the perforating device. The set of instructions may describe a pattern that corresponds to the line of weakness such that the instructions cause the line of weakness to be formed in the anchor element, according to the pattern.

The pattern that describes the line of weakness, either formed in an imprint surface of a stamping device or described by a set of instructions that control the movement of a perforating device, may be predetermine and/or adjustable (e.g. by a user). In this way, a user can design the shape and/or appearance of the line of weakness of the anchor element. The line of weakness comprises a plurality of line segments. The line of weakness may therefore comprise discontinuities, or may comprise a discontinuous line. In these examples, to form the line of weakness, a smaller portion of the anchor element (relative to if the line of weakness was a continuous line) may be imprinted to form the line, thereby affecting the integrity of a reduced area of the anchor element when those areas are imprinted to form the line.

Each segment may comprise a reduced width relative to the remainder of the anchor element. Each segment may comprise an imprinted region (depending on the method that was used to form the line of weakness). The line of weakness may be straight (e.g. substantially straight) or may be curved (e.g. substantially curved). Each line segment forming the line of weakness may be straight (e.g. substantially straight) or curve (e.g. substantially curved).

The line of weakness may be substantially parallel, or substantially perpendicular, to the length of the anchor element. The line of weakness may extend for substantially the length of the anchor element. The line of weakness may substantially bisect the anchor element.

The anchor element may comprise a substantially elliptical shape. In these examples, the line of weakness may be substantially parallel, or coincident, to the major axis or the minor axis of the anchor element.

As stated above, the methods described above may be performed following a step of manufacturing the anchor element. Manufacturing the anchor element may comprise forming an inward-facing surface of the anchor element and an outward-facing surface of the anchor element, the inward-facing surface intended to be face the user when the device is worn in use, and the outward-facing surface intended to face away from the user when the device is in use. As described above, the in-ward facing surface may comprise an absorbent material and the outward-facing surface may comprise a liquid-impermeable material. Accordingly, manufacturing the anchor element may comprise joining an absorbent material to a liquid- impermeable material.

According, the method may comprise providing a material at least part of which is to form the anchor element and cutting the anchor element out of the material. The material may be wound around an unwind roller, the method may comprise unwinding the material from the unwind roller prior to cutting the anchor element out of the material. In these examples, the imprinting of the material may be performed as part of an automated manufacturing process where a ream of material is unwound from an unwind roller and, at a printing station, an imprinting device, under control of a controller, is caused to form the line of weakness in a given area of the ream of material that is to form the anchor element, and will be subsequently cut out. Accordingly, a controller may advance the ream of material in a step-wise, or discrete, fashion. Imprinting the anchor element to form the line of weakness may be performed prior to cutting the anchor element out of the material. In words, cutting the material may be performed after the line of weakness is formed.

According to another example of the disclosure there is provided an apparatus for forming an anchor element of a device, the apparatus comprising a roll of material (e.g. wound on an unwind), means to advance the material from the roll of material through an imprinting station (e.g. a roller configured to advance the material), an imprinting device, , configured to imprint a line of weakness into a portion of the material, means (e.g. a roller) to advance the material from the imprinting station to a cutting station, and a cutting device configured to cut the portion of the material comprising the line of weakness to form an anchor element for the device. The means to advance the material may comprise a roller which may be controller by a controller of the apparatus. The controller may further control at least one of: the advancement of the material, the imprinting device, and the cutting device.

According to another example of the disclosure there is provided a non-transitory and machine-readable medium comprising a set of instructions that, when executed by a control unit of an imprinting device cause the imprinting device to imprint a line of weakness into an anchor element of a device according to a pattern described by the set of instructions. The line of weakness, described by the pattern and set of instructions, may comprise the pattern/line of weakness as described above.

Brief Description of the Drawings

Examples will now be described by way of example only, with reference to the Figures, in which:

Figure 1 schematically shows a side view of a device for insertion into a vaginal or rectal cavity which may be manufactured according to the present invention;

Figure 2 schematically shows an underside view of the device of Figure 1;

Figures 3A-3C schematically show a cross sectional view through the device of Figures 1 and 2; Figure 4 shows a flowchart of an example method 400;

Figure 5a schematically shows an apparatus for use in manufacture of the device for insertion into a vaginal or rectal cavity;

Figure 5b schematically shows an apparatus for use in manufacture of the device with a part of the device in position; and

Figure 6 schematically shows part of an apparatus 600 for manufacturing at least part of the device of Figures 1 and 2.

Detailed Description

Figure 1 shows an example device 1 for insertion into a vaginal or rectal cavity, in this example a sanitary product 1. At least part of the sanitary product 1 is for insertion into the human vagina, e.g. for the absorption of menstrual fluid. The sanitary product comprises a plug 2, in this example an absorbent plug 2 and an anchor element 3, in this example an absorbent pad 3 connected by a sheath 4. The plug 2 is substantially cylindrical so that it fits comfortably within the vagina and comprises an innermost end 5 (being the end that, in use, is inserted into the vagina first) and an outermost end 6 (being the end that, in use, is inserted into the vagina last). The innermost 5 and outermost end 6 each comprise domed ends (for example to aid in the insertion of the plug 2 into the vagina). In other examples, the innermost end 5 and/or the outermost end 6 may comprise a flat end.

Although the detailed description here describes a method and apparatus 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 method and apparatus 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 plug 2 may comprise compressed cotton. The plug 2 may comprise, what is known as, a tampon.

The pad 3 may be elliptical or egg-shaped. As shown in Figure 1 , the perimeter of the pad 3 is elliptical in shape, having a broad end 8 and a narrow end 9, the broad end 8 being wider than the narrow end 9, although in other examples the pad 3 may be of a different shape. The pad 3 comprises an inward-facing surface 10, or inward side, and an outward-facing surface 11 , or outward side 11. The inward side 10 is the side of the pad 3 that is in contact with the vagina, and therefore facing the user, in use. The outward side 11 is the side of the pad that faces away from the user, and is in contact with the user’s clothing, in use. Accordingly, and as shown in Figure 1, the pad 3 may be substantially flat.

The inward side 10 of the pad 3 comprises an absorbent layer and the outward side 11 comprises a liquid impermeable layer. The absorbent layer may comprise compressed cotton. The impermeable layer may comprise a plastics material, for example a polymeric material.

It will be appreciated that in other examples, the internally wearable plug 2 and/or externally wearable anchor element 3 may be non-absorbent.

The sheath 4 is a substantially tubular, substantially cylindrical, sleeve of material, and extends from the outward end 6 of the plug 2 to the inward-facing surface 10 of the pad 3. The sheath 4 is open at one end, and is open on the outward-facing surface 11 of the pad 3. In other words, the sheath 4 comprises a sleeve that is open at one end. This may be to accommodate a user’s finger. For example, the sheath 4 may be dimension (e.g. comprise a diameter) so that a user’s finger can be received in the sheath 4. The sheath 4 may be expandable in a radial direction to accommodate fingers of varying thicknesses.

Figure 2 shows a front view of the inward-facing surface 11 of the pad 3. Figure 2 shows that the pad 3 comprises a line of weakness 7. The line of weakness 7 in the Figure 2 example extends for the length of the pad and is parallel, or coincident, to the major axis of the pad 3 which is elliptical in shape in these examples. The line of weakness 7 runs from the broad end 8 to the narrow end 9 of the pad 3. The line of weakness 7 bisects the pad 3.

As Figure 2 shows, the pad 3 comprises an opening 12. The opening 12 is for receipt of a human finger and/or the absorbent plug 2 of the sanitary product 1. The opening 12 of the pad 3 may coincide with an opening (e.g. the open end) of the sheath 4. The sheath 4 may by attached to the pad 3. The open end of the sheath 4 may be joined to the pad 3 at the opening, e.g. via welding. The line of weakness 7 runs through the opening 12.

As also shown in Figures 1 and 2, the sanitary product 1 comprises a cord 13 attached to the outermost end 6 of the plug 2, to assist in removal of the plug 2 from the vaginal cavity.

In the example shown in Figure 2, the line 7 comprises a continuous line (even though the line 7 runs through the opening 12 in the Figure 2b example it can still be considered to be a continuous line in the sense that its discontinuity is due to the opening 12). In other examples, the line 7 may comprise discontinuities. Such an example will be described later.

It will be appreciated that the line of weakness 7 may be formed in the inward-facing surface 11, the outward-facing surface 10, or in both surfaces (in which case the line may be considered to be formed in the entire pad 3).

The line of weakness 7 may be formed by an imprinting process, in which the line 7 is imprinted into the pad 3.

Figures 3A-3C show cross-sectional views of the pad 3 shown in Figure 2 taken, respectively, along the lines A-A, B-B, and C-C, in the example where the line of weakness 7 is formed by imprinting. Figure 3B shows the opening 12 in the pad 3 and therefore the line of weakness 7 is not shown in Figure 3B, but is shown in Figures 3A and 3C. Figures 3A and 3C show that the line of weakness 7 comprises imprinted, or indented, regions, having a thickness less than the overall thickness of the pad, formed by imprinting.

Figure 4 shows a flowchart of an example method 400, which may comprise a computer implemented method, and which may be a method of manufacturing (at least a portion of, e.g. the pad of) the sanitary product 1 shown in Figures 1-3 above. The method 400 may comprise a method of forming a line of weakness in a pad in a sanitary product (e.g. the sanitary product as described above).

At step 402, the method 400 comprises providing a pad to be worn outside the vagina when the sanitary product is in use, for example the pad 3 as described above.

At step 404, the method 400 comprises forming a line of weakness in the externally wearable pad such that the pad is disposed to fold about the line of weakness, for example the line of weakness 7 as described above.

As indicated by block 406, step 404 of the method may comprise imprinting the pad to form the line of weakness. According to step 406, the line of weakness comprises an imprinted region.

As described above with respect to Figure 1 , the pad may comprise an inward-facing surface and an outward-facing surface, the inward-facing surface intended to be face the user when the sanitary product is worn in use, and the outward-facing surface intended to face away from the user when the sanitary product is in use. In such examples, block 406, respectively, may comprise imprinting, the outward-facing surface of the pad.

Blocks 406 and 408, respectively, may comprise actuating, by a controller, a stamping device, to form the line of weakness in the pad.

Step 402, where the pad is provided, may comprise unwinding a roll of material from a unwind roller. Step 402 may comprise advancing a roll of material through an imprinting station, at which a portion of the material corresponding to the pad is imprinted. In this example the imprinting station may comprise an imprinting device, such as a stamping device or a partial perforating device.

Figure 5a shows one such device 500, which in this example comprises a stamping device. The stamping device 500 comprises an imprint surface 510, the imprint surface of this example comprising a first pattern 512 corresponding to a line of weakness that is to be formed a pad (not shown). The imprint surface 510 also comprises a second pattern 513 corresponding, in this example, to a logo to be formed in the pad.

This process may be automated in which case a controller (not shown) of the device 500 may be to control movement of the device, e.g. to cause the line of weakness to be formed in the pad. In this example, the stamping device 500 may be part of a manufacturing line. An imprinting station may therefore comprise the stamping device 500. Accordingly, a roll of material may be advanced through the stamping device such that the stamping device 500 is caused to imprint the line of weakness in an area of material that will correspond to the pad.

The device 500 comprises a movable anvil 515. When the anvil 515 applies a compressive force against a pad that is positioned on the imprint surface 510, the pattern 512, 513 (including the line of weakness) will be formed in the pad. This is shown in Figure 5b. Figure 5b shows a pad 3 being supported on the imprint surface 510. The anvil 515 is movable in the direction of arrow X to apply a compressive force to the pad 3 and cause the pattern formed on the imprint surface 510 to be imprinted into the pad 3. The pad 3 may be positioned such that the inward-facing surface 11 faces toward the imprint surface 510. In other words, the outward-facing surface 10 faces toward the anvil 515. In this example, the imprint surface 510 is opposite the anvil 515 but in other examples the anvil 515 may comprise the imprint surface 510. Referring back to the Figure 4, the method may comprise actuating, by a controller, a stamping device (e.g. the stamping device 500 of Figure 5) to imprint the line of weakness into the pad. For example, the controller may cause the anvil 515 of the stamping device to move in the direction X to apply a compressive force to the pad 3 to form the line of weakness in the pad.

Figure 6 shows part of an apparatus 600 for manufacturing at least part of a sanitary product, e.g. a pad thereof, comprising a means to advance a sheet of material through an imprinting station, and/or a cutting station, to imprint, at the printing station, a line of weakness into the material and to cut, from the sheet of material, a pad, the pad comprising the line of weakness. The apparatus 600 comprises the unwind roller 601 , imprinting station 610 (comprising the imprinting device 615) and cutting station 620 (comprising the cutting device 625). The apparatus 600 comprises a controller 690 to control at least one of the advancement of the material, actuation of the imprinting device, and actuation of the cutting device.

An automated manufacturing process will now be described with reference to the apparatus 600 of Figure 6. In this example, an unwind 601 of material 602 is advanced, via intermediate rollers 603 and 604 (schematically shown at 603 and 604 in order to produce the required tension in the material 602, through an imprinting station 610 and thereafter through a cutting station 620. At imprinting station 610, a line of weakness is imprinted into a portion of the material (that is to correspond to the pad) by an imprinting device 615 (such as that shown in Figure 5) via the compressive action of an anvil onto a surface. For example, the anvil may cause the material to be compressed against an imprinting surface, as shown in Figure 5, or an anvil comprising the imprinting surface may cause the material to be compressed against a further surface. Thereafter, the material advances to the cutting station 620 where a cutting device 625 causes the portion of the material that corresponds to the pad (and which has been imprinted at the imprinting station 610) to be separated, e.g. cut away from, the remainder of the material. As the material further advances, the now cut-out pad falls into a container 630 where they are collected and the remainder of the material is wound on a rewind roller 640. It will be understood that in other examples, the cutting station 620 may be placed before the imprinting station 610.

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

1. A method for manufacturing a device for insertion into a vaginal or rectal cavity, the method comprising: providing an anchor element to be worn outside the cavity when the device is in use; and forming a line of weakness in the externally wearable anchor element such that the anchor element is disposed to fold about the line of weakness, wherein forming the line of weakness comprises: imprinting the anchor element to form the line of weakness.

2. The method of claim 1, wherein providing the anchor element comprises: providing a material at least part of which is to form the anchor element; and cutting the anchor element out of the material.

3. The method of claim 2, wherein imprinting the anchor element to form the line of weakness is performed prior to cutting the anchor element out of the material.

4. The method of claim 2 or 3, wherein the material is wound around an unwind roller, the method further comprising: unwinding the material from the unwind roller prior to cutting the anchor element out of the material.

5. The method of any preceding claim, wherein the anchor element comprises an inward facing surface and an outward-facing surface, the inward-facing surface intended to be face the user when the device is worn in use, and the outward-facing surface intended to face away from the user when the device is in use, and wherein forming the line of weakness comprises: imprinting the outward-facing surface of the anchor element.

6. The method of any preceding claim, further comprising: providing a sheath; and attaching the imprinted anchor element to a sheath of the device.

7. The method of any preceding claim, further comprising: actuating, by a controller, a stamping device to imprint the line of weakness into the anchor element.

8. The method of any preceding claim, wherein the stamping device is actuated to apply a pressure of 6 bar to the pad to imprint the line of weakness into the anchor element.

9. The method of claim 7 or 8, further comprising actuating, by a controller, the stamping device to imprint a pattern into the anchor element.

10. The method of claims 7-9 wherein the stamping device comprises an embossing or debossing device.

11. The method of any preceding claim wherein the line of weakness comprises a plurality of line segments.

12. The method of any preceding claim wherein the line of weakness is substantially parallel to the length of the anchor element.

13. The method of any of claims 1-12 wherein the line of weakness is substantially perpendicular to the length of the anchor element.

14. The method of any preceding claim wherein the line of weakness extends the length of the anchor element.

15. The method of any preceding claim wherein the line of weakness substantially bisects the anchor element.

16. The method of any preceding claims wherein the line of weakness is substantially straight.

17. The method of any preceding claim, wherein the plug of the device comprises an absorbent plug.

18. The method of any preceding claim, wherein the device is a sanitary product for insertion into a vagina.

19. The method of any preceding claim, wherein the anchor element is an absorbent pad.

20. A non-transitory and machine-readable medium comprising a set of instructions that, when executed by a control unit of an imprinting device, cause the imprinting device, to imprint, a line of weakness into an anchor element of a device according to a pattern described by the set of instructions.

21. An apparatus for forming an anchor element of a device, the apparatus comprising: a roll of material; means to advance the material from the roll of material through an imprinting station; an imprinting device, configured to imprint a line of weakness into a portion of the material; and means to advance the material from the imprinting station to a cutting station; a cutting device configured to cut the portion of the material comprising the line of weakness to form an anchor element for the device.

22. The apparatus of claim 21 further comprising a controller to control at least one of: the advancement of the material, the imprinting device, and the cutting device.