WO2021122467A1 - Devices for insertion into a vaginal or rectal cavity - Google Patents

Devices for insertion into a vaginal or rectal cavity Download PDF

Info

Publication number
WO2021122467A1
WO2021122467A1 PCT/EP2020/086005 EP2020086005W WO2021122467A1 WO 2021122467 A1 WO2021122467 A1 WO 2021122467A1 EP 2020086005 W EP2020086005 W EP 2020086005W WO 2021122467 A1 WO2021122467 A1 WO 2021122467A1
Authority
WO
WIPO (PCT)
Prior art keywords
plug
seal
heat sealing
heat
protective sheath
Prior art date
Application number
PCT/EP2020/086005
Other languages
French (fr)
Inventor
Yu Sing Hooi
Vinh-Thang VO-TA
Original Assignee
Calla Lily Personal Care Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Calla Lily Personal Care Ltd filed Critical Calla Lily Personal Care Ltd
Priority to EP20837937.0A priority Critical patent/EP4090517A1/en
Publication of WO2021122467A1 publication Critical patent/WO2021122467A1/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/2082—Apparatus or processes of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/2082—Apparatus or processes of manufacturing
    • A61F13/2085—Catamenial tampons
    • A61F13/2097—Catamenial tampons method of manufacturing tampon applicators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/345—Progressively making the joint, e.g. starting from the middle
    • B29C66/3452—Making complete joints by combining partial joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81411—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat
    • B29C66/81421—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave
    • B29C66/81423—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave being concave
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8145—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/81463—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps comprising a plurality of single pressing elements, e.g. a plurality of sonotrodes, or comprising a plurality of single counter-pressing elements, e.g. a plurality of anvils, said plurality of said single elements being suitable for making a single joint
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
    • B29C66/924—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools
    • B29C66/9241—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force or the mechanical power
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
    • B29C66/929—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools characterized by specific pressure, force, mechanical power or displacement values or ranges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/94—Measuring or controlling the joining process by measuring or controlling the time
    • B29C66/944—Measuring or controlling the joining process by measuring or controlling the time by controlling or regulating the time
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/94—Measuring or controlling the joining process by measuring or controlling the time
    • B29C66/949—Measuring or controlling the joining process by measuring or controlling the time characterised by specific time values or ranges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/82—Testing the joint
    • B29C65/8207—Testing the joint by mechanical methods
    • B29C65/8223—Peel tests
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/812—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
    • B29C66/8122—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps characterised by the composition of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91421—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the joining tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
    • B29C66/924—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools
    • B29C66/9261—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the displacement of the joining tools

Definitions

  • This invention relates to a method and apparatus 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 method and apparatus 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.
  • 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.
  • 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.
  • a method for manufacturing at least part of a device for insertion into a vaginal or rectal cavity 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 may be attached to part of the plug and 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a tool 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 plug may comprise what may be known as a tampon.
  • the plug may comprise a substantially cylindrical plug.
  • the protective sheath may be sized such that a wearer’s finger can be received in the sheath to assist insertion of the plug.
  • the sheath may be elastic in only a circumferential direction.
  • internally worn may mean inside the cavity. In other words, it may mean inwardly of the cavity orifice.
  • the externally worn anchor element (joined to an opposite end of the sheath to the plug) may be intended to be worn outside the cavity.
  • 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 device comprises a sheath that joins the anchor element to the plug.
  • the sheath is attached, e.g. sealed, to both the anchor element and the plug.
  • a manufacturing process to manufacture the device may therefore comprise joining the sheath to the plug and joining the sheath to the anchor element.
  • a method to manufacture (part of a) device for insertion into a vaginal or rectal cavity.
  • the method comprises providing an plug configured to be worn inside a vaginal or rectal cavity, providing a protective sheath configured to accommodate at least part of the plug, and heat sealing (e.g. thermal sealing) at least part of the protective sheath to a first end of the plug.
  • the heat sealing comprises at least one of: heat sealing at a temperature of between 100 and 200°C, in one example between 105 and 120 °C, or in yet another example approximately 110°C, heat sealing at a pressure of between 3 and 7 bar, in one example between 5.5 and 6.5 bar, or in yet another example approximately 6 bar, and heat sealing for a duration of between 0.5 and 4 seconds, in one example between 2 and 3 seconds, in yet another example approximately 2.5 seconds.
  • the heat sealing may be performed at a temperature of greater than 106 °C, or at least 107°C.
  • the heat sealing of the protective sheath to the plug may therefore take place by applying heat and pressure to the protective sheath and plug for a period of time (e.g. for a temperature and/or a pressure and/or for a duration as described above).
  • heat sealing parameters may result in a thermal seal that is strong enough to resist separation of the plug and the protective sheath during insertion or removal of the device, without damaging or weakening the plug or protective sheath.
  • a heat seal which damages and/or weakens the sheath material may cause perforations to occur around the very top perimeter of the heat seal. This may cause a premature failure when force is applied. This may occur if excessive heat, pressure or cycle time is provided during heat sealing.
  • heat sealing or “thermal sealing” it is meant the use of head to join two articles, for example the use of heat and/or pressure to form an attachment, e.g. an attachment between two articles to be heat, or thermally, sealed.
  • the result of a “heat sealing” or “thermal sealing” process is a heat seal.
  • the term “heat sealing” or “thermal sealing” is intended to comprise “welding”. Therefore, examples of this disclosure relate to applying heat to weld at least a portion of the sheath to at least a portion of the plug.
  • Heat sealing at least part of the protective sheath to a first end of the plug may comprise at least one of: heat sealing at a temperature of greater than 106 °C, or between 105 and 120 °C, for example approximately 110 °C, heat sealing at a pressure of between 5.5 and 6.5 bar (e.g. 6 bar), and heat sealing for a duration of between 2-3 seconds (e.g. 2.5 seconds). These heat sealing parameters may be particularly preferable to give a desired heat seal strength.
  • At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a peel-back force of at least 2N per 15mm outer circumference of the plug.
  • peel-back force may refer to an initial pull force required to separate the heat sealed sheath from the lateral surface of the plug.
  • At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a peel-back force of at least 0.2kg, optionally at least 0.4kg.
  • At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a separation force of at least 0.4kg, optionally at least 0.6kg.
  • seal “separation force” may refer to a pull force required to completely separate the sheath from the plug.
  • the separation force is typically higher than the peel back force as exposed fibres in an end region of the plug may bond strongly with the sheath during heat sealing.
  • the plug may have an axial length. At least part of the protective sheath may be heat sealed to the first end of the plug such that the heat sealing extends along at least 20% of the axial length of the plug.
  • Heat sealing at least part of the protective sheath to a first end of the plug may comprise heat sealing part of the sheath to part of the first end of the plug at a plurality of seal regions, the seal regions being offset from one another around an exterior surface of the plug.
  • Heat sealing at least part of the protective sheath to a first end of the plug may comprise heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions.
  • the second plurality of seal regions may be offset around the exterior surface of the plug from the first plurality of seal regions.
  • the heat seal regions may be offset around a lateral surface of the plug so as to provide a heat seal substantially around the entire circumferential surface of the plug.
  • the heat seal regions may overlap or be separated by non-heat sealed regions.
  • the first and second pluralities of seal regions may each comprise 3 seal regions.
  • the two sealing stages may both be performed automatically via the actuation of six sealing arms, each having a sealing head (e.g. comprising a thermal element to apply heat to perform the seal).
  • the sealing arms may also be individually referred to as “jaws” or “sealing jaws”.
  • a method of manufacturing (at least part of) a device (at least part of which is suitable) for insertion into a vaginal or rectal cavity comprising providing an plug configured to be worn inside the vaginal or rectal cavity, providing a protective sheath configured to accommodate at least part of the plug, heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions, the second plurality of seal regions being offset around the exterior surface of the plug from the first plurality of seal regions.
  • This method may comprise actuating a set of six sealing arms.
  • the first stage may comprise actuating three of the six sealing arms and the second stage may comprise actuating the remaining three. More generally, the method may comprise actuating a first plurality of sealing heads to seal the sheath and plug at the first plurality of seal regions and actuating a second plurality of sealing heads to seal the sheath and plug at the second plurality of seal regions.
  • the sealing heads may each be offset from one another in a circumferential direction.
  • the sealing heads may be radially movable toward and away from one another, and may be movable independently of one another.
  • the method described herein may comprise a method of heat sealing at least of a protective sheath of a device to at least part of a plug of a device.
  • a heat sealing apparatus for use in a method of manufacturing (at least part of) a device (at least part of which is suitable) for insertion into a vaginal or rectal cavity, for example the device as described above.
  • the device may therefore comprise a plug configured to be worn inside the vaginal or rectal cavity and a protective sheath configured to accommodate at least part of the plug.
  • the sealing apparatus may comprising a sealing head configured to heat seal at least part of the protective sheath to at least part of a first end of the plug, and a controller configured to cause the heat seal to at least one of: heat seal at a temperature of between 100 and 200°C, heat seal at a pressure of between 3 and 7 bar, and heat seal for a duration of between 0.5 and 4 seconds, to heat seal part of the protective sheath to the first end of the plug.
  • the controller may be configured to cause the heat seal to apply a temperature of between 100 and 200°C to an overlapping area of the sheath and plug; cause the heat seal to apply a pressure of between 3 and 7 bar to an overlapping area of the sheath and plug; and cause the heat seal to apply a temperature and/or a pressure to an overlapping area of the sheath and plug for between 0.5 and 4 seconds.
  • the controller may be configured to cause the head to at least one of: heat seal at a temperature of between 110°C, heat seal at a pressure of between 5.5 and 6.5 bar (e.g. 6 bar), and heat seal at a duration of between 2 and 3 seconds (e.g. 2.5 seconds), to heat seal part of the protective sheath to the first end of the plug.
  • the controller may be configured to cause the heat seal to apply a temperature of 110°C to an overlapping area of the sheath and plug; cause the heat seal to apply a pressure of between 5.5 and 6.5 bar (e.g. 6 bar) to an overlapping area of the sheath and plug; and cause the heat seal to apply a temperature and/or a pressure to an overlapping area of the sheath and plug for between 2 and 3 seconds (e.g. 2.5 seconds).
  • The, or each, head may comprise a polytetrafluoroethylene (PTFE) coating.
  • the coating may comprise a Teflon coating.
  • the coating may comprise Impreglon XP1301 in some examples. This may result in more efficient heat transfer which, in turn, may allow for a reduced heat seal temperature and/or cycle time during production. This may also give a more consistent and improved heat seal when compared with other coatings.
  • the heat sealing apparatus may further comprise a control unit for controlling the actuation of the sealing head.
  • the head may comprise a curved surface, sometimes referred to as a “radiused edge”.
  • the sealing head may comprise a sealing surface having a curvature substantially conforming to the curvature of the plug. In this way, when the sealing surface exerts a force against the absorbent plug (to seal part of the sheath to the plug) deformation of the plug will be minimised, and the chance of perforations forming in the heat seal will be reduced.
  • the curved surface may therefore be configured to conform to an outer profile of the plug.
  • the controller may be configured to cause the head to heat seal part of the protective sheath to the first end of the plug along at least 20% of an axial length of the plug.
  • the controller may be configured to cause the sealing head of the sealing apparatus to exert a sealing force along 20% of the axial length of the plug.
  • the head may comprise a first and second plurality of head portions, wherein the first plurality is independently actuatable from the second plurality.
  • the controller may be configured to cause the first plurality of head portions to heat seal a first region of the protective sheath to a first region of the plug at a first seal region and to cause the second plurality of head portions to heat seal a second region of the protective sheath to a second region of the plug at a second seal region, the first and second seal regions being offset around the exterior surface of the plug from the first plurality of seal regions.
  • the heat seal regions may be configured to overlap. This may ensure a heat seal is provided substantially around the entire exterior surface of the plug by accounting for manufacturing tolerances.
  • the apparatus may comprise six head portions.
  • the first and second plurality of head portions may each comprise three head portions.
  • a sealing apparatus for use in a method of manufacturing (at least part of) a device (e.g. as described above) comprising a plug configured to be worn inside a vaginal or rectal cavity and a protective sheath configured to accommodate at least part of the plug, the apparatus comprising: a first plurality of heads and second plurality of heads, wherein the first plurality is independently actuatable from the second plurality.
  • the first and second plurality of sealing heads may be circumferentially offset from one another and radially movable towards and away from one another.
  • the first plurality of heads may be concurrently actuatable, e.g. actuatable in tandem.
  • the second plurality of heads may be concurrently actuatable, e.g. actuatable in tandem.
  • a non-transitory machine readable medium having a set of instructions stored thereon such that, when executed by a processor of a heat sealing machine, the instructions are to cause a sealing surface of the heat sealing machine to apply a pressure and temperature, for a duration, to at least part of a protective sheath of a device for insertion into a vaginal or rectal cavity to a first end of a plug of a device for insertion into a vaginal or rectal cavity to heat seal the sheath to the plug, wherein the instructions are to cause the sealing surface to at least one of: apply a temperature of between 100 and 200°C, apply a pressure of between 3 and 7 bar, apply a temperature and pressure for a duration of between 0.5 and 4 seconds.
  • the conditions for heat sealing according to the method, apparatus, or instructions described above may comprise a temperature of greater than 106 °C, e.g. at least 107 °C.
  • the temperature may be between 100 and 200°C.
  • the temperature may be between 105 and 120 °C.
  • the temperature may be 110 °C.
  • the conditions may comprise a pressure of between 3 and 7 bar.
  • the pressure may be between 5.5 and 6.5 bar.
  • the pressure may be 6 bar.
  • the time duration that the temperature and pressure is applied for to effect the heat seal may be between 0.5 and 4 seconds.
  • the duration may be between 2 and 3 seconds.
  • the duration may be 2.5 seconds.
  • Figure 1 schematically shows a perspective view of an apparatus according to the invention in a load position
  • Figures 2 and 3 schematically show a device for insertion into a vaginal or rectal cavity which may be manufactured using the apparatus of Figures 1-4;
  • Figure 4 schematically shows a perspective view of the apparatus of Figure 1 in a first heat seal position;
  • Figure 5 schematically shows a perspective view of the apparatus of Figures 1 and 2 in a second heat seal position
  • Figure 6 schematically shows a plan view of the apparatus of Figure 1 ; and Figure 7 shows the steps of an exemplary method of using the apparatus of Figures
  • Figure 1 shows a sealing apparatus 10 comprising a plurality of sealing heads 12, 14, 16, 18, 20, 22.
  • the sealing heads are each evenly, and circumferentially, spaced around a central region 24.
  • the central region 24 is for receipt of a plug of a device.
  • 6 heads are provided, offset by 60°, about the central region 24 but in other examples a different number of heads may be provided and may be offset by a different angle. Indeed, any number of heads (including 1) may be provided according to this disclosure.
  • Each of the heads 12, 14, 16, 18, 20, 22 is linearly, or translatably, movable in a radial direction, i.e. towards and away from the central region 24, and towards and away from one another, by an actuator disposed on each head.
  • a single actuator may actuate the movement of all heads.
  • the actuation of each head 12, 14, 16, 18, 20 may be controlled by a controller 28, for example the controller may operate on instructions that are to cause the movement of the sealing heads.
  • the controller 28 is configured to control the heat sealing conditions of the apparatus 10, such as temperature, pressure, and time.
  • the controller 28 is configured to control the apparatus 10 so as to heat seal a region of a sheath to a region of a plug (as will be described below) at a temperature of between 100 and 200°C (e.g. between 105 and 120 °C, for example 110°C), at a pressure of between 3 and 7 bar (e.g.
  • each sealing head may comprise a heating element and the controller may be to control the actuating and/or temperature of the heating element.
  • the controller may be to control the heating element such that the target pressure is applied to the sheath and plug by a sealing surface of each sealing head.
  • the controller may be configured to control the movement of each sealing head so that the target pressure is applied to the sheath and plug by the sealing surface of each sealing head.
  • the apparatus 10 may be used in a process to manufacture a device.
  • FIG. 2 shows an example device 50, in this example a 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 absorbent plug 52 is substantially cylindrical and has an axial length L and a radius R.
  • 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, and is to assist in removal of the absorbent plug 52 from the cavity.
  • the cord 58 comprises two strands of string 60, 62 joined together by a knot 66 to form a loop 64 of material, but in other examples the cord 58 may comprise a single strand.
  • the absorbent pad 52 and the sheath 56 can be inverted over the absorbent plug 52. This configuration of the device is shown in Figure 3. It will also be appreciated that in other examples, the internally wearable plug 52 and/or externally wearable anchor element 54 may be non-absorbent.
  • FIG 3 shows a heat sealed region 68, or weld region, formed by the sheath 56 and absorbent plug 52 in a region opposite the join of the sheath 56 to the pad 54.
  • the heat seal region 68 may be formed using the apparatus 10 as shown in Figure 1 , as will be described below with reference to Figures 4 and 5.
  • the sheath 56 may comprise a flexible plastics material and may be radially expandable.
  • the absorbent plug 52 is made from compressed cotton or such like.
  • the cord 58 may extend through the sheath 56, and movement of the cord may cause the plug 52 to move. For example, pulling the cord 58 may create a tension in the cord that causes the plug 52 to move. Pulling the cord on the device 50, in its Figure 2 configuration, may cause the plug 52 to advance towards the pad 54, through the sheath 56, and through an opening in the pad 54 and may cause the device to be in the “inverted” configuration shown in Figure 3.
  • the heads 12, 14, 16, 18, 20, 22 comprise a first plurality of heads 12, 16, 20 and a second plurality of heads 14, 18, 22.
  • the first plurality of heads 12, 16, 20 are configured to be actuatable concurrently, e.g. in tandem with one another.
  • the second plurality of heads 14, 18, 22 are configured to be actuatable concurrently, e.g. in tandem with one another.
  • the first and second pluralities of heads are independently actuatable from one another. In this way, the heat sealing can take place in two stages.
  • the first plurality of heads 12, 16, 20 are moved into engagement with the sheath and plug of a device that is placed in the central region 24 to apply a pressure and temperature to the plug and sheath to heat seal the plug and sheath in a first plurality of sealing regions.
  • the second plurality of heads 14, 18, 22 are moved into engagement with the sheath and plug of a device that is placed in the central region 24 to apply a pressure and temperature to the plug and sheath to heat seal the plug and sheath in a second plurality of sealing regions.
  • the first and second pluralities of heads are offset in a circumferential region and, accordingly, the first and second sealing regions are offset in a circumferential region. However, adjacent portions of the first and second sealing regions may overlap.
  • FIGS 4 and 5 respectively, show the apparatus in the first and second sealing stages.
  • Figure 4 shows the first plurality of sealing heads 12, 16, 20 moved into sealing engagement with a plug 52 and a sheath 56 of a device.
  • the apparatus is shown sealing the plug and sheath at a first plurality of sealing regions, each sealing region corresponding to a respective sealing head 12, 16, 20 (having a heating element therein for generating a target pressure to seal the sheath and plug).
  • each sealing region corresponding to a respective sealing head 14, 18, 22 (having a heating element therein for generating a target pressure to seal the sheath and plug).
  • some of the sealing regions may overlap.
  • the degree of overlap will depend, at least in part, on the circumferential spacing of the sealing heads.
  • Each sealing head may comprise a curved sealing surface whose curvature substantially conforms to the curvature of the exterior surface of the plug 52.
  • Each sealing head may therefore comprise an arcuate surface.
  • the radius (of curvature) of the or each sealing surface may be approximately 2mm. This size ensures that the shape of the sealing head conforms to the outer surface of the plug.
  • Figure 6 shows a plan view of the apparatus 10 surrounding an absorbent plug 52 to be heat sealed, the heads 12, 14, 16, 18, 20, 22.
  • Figure 6 shows the curved sealing surface, one of which is labelled 30, of each sealing head.
  • each sealing head comprises a sealing surface configured to apply heat to an object to be sealed, and in this example the sealing surface comprises a curved surface.
  • the surface of each sealing surface comprises substantially a portion of a circumference of a circle.
  • the surface of each sealing portion comprises slightly more than a sixth of a circumference of a circle, there being six sealing heads in this example, such that overlap is formed between the seal regions formed by the first and second plurality of heads.
  • each sealing portion comprises a sixth of a circumference of a circle such that there is no overlap between the seal regions formed by the first and second plurality of heads.
  • the curved surface of each sealing portion may comprise less than a sixth of a circumference of a circle.
  • the first plurality of heads 12, 16, 20 may substantially surround the whole circumference of the device 50 to be heat sealed (as shown in Figure 4).
  • the second plurality of heads 14, 18, 22 may substantially surround the whole circumference of the device 50 to be heat sealed (as shown in Figure 5).
  • the depth of the contact surface, in a direction along the length of the device 50 to be heat sealed, is such that the resultant heat seal has a depth of substantially 20% of the length of the absorbent plug 52.
  • the height of the contact surface, or sealing surface, of each head will correspond to the depth of the seal (or weld).
  • Each of the heads 12, 14, 16, 18, 20, 22 may comprise a polytetrafluoroethylene coating, so as to provide improved heat transfer to the device 50 during heat sealing.
  • Figure 7 shows a method 100 of manufacturing at least part of a device, for example the device 50 as described above, using the apparatus of Figures 1, and 4-6.
  • an unwelded device 50 e.g., as shown in Figure 3
  • the cord 58 of the device may be withdrawn into a recess in the central region 24, using suction, such that it is removed out of the plane of the heads 12, 14, 16, 18, 20, 22.
  • a controller may be configured to create a suction force so as to draw the cord of the device into a recess of the apparatus.
  • the automated arms hold the device 50 in position during the heat sealing steps.
  • a second step 104 the first plurality of heads 12, 16, 20 are actuated to move towards an exert a sealing force on the device 50 (to the position as shown in Figure 4) and, in example, apply a pressure of between 0.55 at a temperature of approximately 110 °C, for a duration of between 2-3 seconds, so as to heat seal the sheath 56 to the plug 52.
  • a third step 106 the first plurality of heads 12, 16, 20 are actuated away from the device 50, and the second plurality of heads 14, 18, 22 are actuated towards the device 50.
  • the second plurality of heads 14, 18, 22 apply a pressure of between 0.55 at a temperature of approximately 110 °C, for a duration of between 2-3 seconds, so as to heat seal the sheath 56 to the plug 52.
  • the heat seal is formed in two steps, which ensures that the sheath 56 is sealed to the plug 52 at substantially the entire circumference of the plug.
  • the resultant heat seal can be characterized by two strength properties- a peel-back force and a separation force.
  • the peel-back force is defined as an initial pull force required to separate the heat sealed sheath 56 from the circumferential surface of the absorbent plug 52.
  • the peel-back force of a heat seal as formed above may be approximately 2N/15mm. That is, manual testing of the heat seal may apply a force of 4N (in a so called “weld test”).
  • the target peel-back force is approximately 2N per segment of the outer circumferential surface of the plug, in one example 2N per 15mm of the circumference of the plug.
  • the separation force is a pull force required to completely separate the sheath from the absorbent plug.
  • the separation force is typically higher than the peel back force as exposed fibres in an end region of the absorbent plug bond strongly with the sheath during heat sealing.
  • the separation force of a heat seal as formed above is 0.6kg.
  • a next step 108 the second plurality of heads 14, 18, 22 are actuated away from the device 50, and the automated arms move the device 50 on to a packaging process.
  • the process described by the method of Figure 7 may be performed after a process of joining the sheath to the plug (e.g. at the cord of the plug).
  • a plurality of sealing heads are described and depicted it is emphasized that an apparatus with a single head is within the scope of this disclosure, the sealing head being actuatable or controllable, to produce a temperature and pressure as described above.
  • the sheath may be sealed to the plug in a single sealing region or at least one of the sealing head or device may be moved, e.g. rotated, in order to effect sealing in a plurality of sealing regions.

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Abstract

A method of manufacturing a device (50) for insertion into a vaginal or rectal cavity. The method comprises providing a plug (52) configured to be worn inside the cavity, and providing a protective sheath (56) configured to accommodate at least part of the plug (52). The method then comprises heat sealing at least part of the protective sheath (56) to a first end of the plug (52) by at least one of: heat sealing at a temperature of between 100 and 200°C, heat sealing at a pressure of between 3 and 7 bar, and heat sealing for a duration of between 0.5 and 4 seconds.

Description

Devices for insertion into a vaginal or rectal cavity
This invention relates to a method and apparatus 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 method and apparatus 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 a method of manufacturing 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 may be attached to part of the plug and 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 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 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 plug may comprise what may be known as a tampon. The plug may comprise a substantially cylindrical plug. The protective sheath may be sized such that a wearer’s finger can be received in the sheath to assist insertion of the plug. The sheath may be elastic in only a circumferential direction. In the context of this invention, internally worn may mean inside the cavity. In other words, it may mean inwardly of the cavity orifice.
The externally worn anchor element (joined to an opposite end of the sheath to the plug) may be intended to be worn outside the cavity. 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.
As stated above, the device comprises a sheath that joins the anchor element to the plug. For this purpose, the sheath is attached, e.g. sealed, to both the anchor element and the plug. A manufacturing process to manufacture the device may therefore comprise joining the sheath to the plug and joining the sheath to the anchor element.
According to an example of the disclosure there is provided a method to manufacture (part of a) device (at least part of which is suitable) for insertion into a vaginal or rectal cavity. The method comprises providing an plug configured to be worn inside a vaginal or rectal cavity, providing a protective sheath configured to accommodate at least part of the plug, and heat sealing (e.g. thermal sealing) at least part of the protective sheath to a first end of the plug. The heat sealing comprises at least one of: heat sealing at a temperature of between 100 and 200°C, in one example between 105 and 120 °C, or in yet another example approximately 110°C, heat sealing at a pressure of between 3 and 7 bar, in one example between 5.5 and 6.5 bar, or in yet another example approximately 6 bar, and heat sealing for a duration of between 0.5 and 4 seconds, in one example between 2 and 3 seconds, in yet another example approximately 2.5 seconds.
In one example, the heat sealing may be performed at a temperature of greater than 106 °C, or at least 107°C. The heat sealing of the protective sheath to the plug may therefore take place by applying heat and pressure to the protective sheath and plug for a period of time (e.g. for a temperature and/or a pressure and/or for a duration as described above).
These heat sealing parameters may result in a thermal seal that is strong enough to resist separation of the plug and the protective sheath during insertion or removal of the device, without damaging or weakening the plug or protective sheath. A heat seal which damages and/or weakens the sheath material may cause perforations to occur around the very top perimeter of the heat seal. This may cause a premature failure when force is applied. This may occur if excessive heat, pressure or cycle time is provided during heat sealing.
Herein, by “heat sealing” or “thermal sealing” it is meant the use of head to join two articles, for example the use of heat and/or pressure to form an attachment, e.g. an attachment between two articles to be heat, or thermally, sealed. The result of a “heat sealing” or “thermal sealing” process is a heat seal. The term “heat sealing” or “thermal sealing” is intended to comprise “welding”. Therefore, examples of this disclosure relate to applying heat to weld at least a portion of the sheath to at least a portion of the plug.
Heat sealing at least part of the protective sheath to a first end of the plug may comprise at least one of: heat sealing at a temperature of greater than 106 °C, or between 105 and 120 °C, for example approximately 110 °C, heat sealing at a pressure of between 5.5 and 6.5 bar (e.g. 6 bar), and heat sealing for a duration of between 2-3 seconds (e.g. 2.5 seconds). These heat sealing parameters may be particularly preferable to give a desired heat seal strength.
At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a peel-back force of at least 2N per 15mm outer circumference of the plug. As used herein, the term “peel back force” may refer to an initial pull force required to separate the heat sealed sheath from the lateral surface of the plug.
At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a peel-back force of at least 0.2kg, optionally at least 0.4kg.
At least part of the protective sheath may be heat sealed to the first end of the plug such that the completed seal has a separation force of at least 0.4kg, optionally at least 0.6kg.
As used herein the term seal “separation force” may refer to a pull force required to completely separate the sheath from the plug. The separation force is typically higher than the peel back force as exposed fibres in an end region of the plug may bond strongly with the sheath during heat sealing.
The plug may have an axial length. At least part of the protective sheath may be heat sealed to the first end of the plug such that the heat sealing extends along at least 20% of the axial length of the plug.
Heat sealing at least part of the protective sheath to a first end of the plug may comprise heat sealing part of the sheath to part of the first end of the plug at a plurality of seal regions, the seal regions being offset from one another around an exterior surface of the plug.
Heat sealing at least part of the protective sheath to a first end of the plug may comprise heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions. The second plurality of seal regions may be offset around the exterior surface of the plug from the first plurality of seal regions.
The heat seal regions may be offset around a lateral surface of the plug so as to provide a heat seal substantially around the entire circumferential surface of the plug. The heat seal regions may overlap or be separated by non-heat sealed regions. The first and second pluralities of seal regions may each comprise 3 seal regions.
As will be described below, the two sealing stages may both be performed automatically via the actuation of six sealing arms, each having a sealing head (e.g. comprising a thermal element to apply heat to perform the seal). The sealing arms may also be individually referred to as “jaws” or “sealing jaws”.
According to one example of this disclosure there is provided a method of manufacturing (at least part of) a device (at least part of which is suitable) for insertion into a vaginal or rectal cavity, the method comprising providing an plug configured to be worn inside the vaginal or rectal cavity, providing a protective sheath configured to accommodate at least part of the plug, heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions, the second plurality of seal regions being offset around the exterior surface of the plug from the first plurality of seal regions. This method may comprise actuating a set of six sealing arms. The first stage may comprise actuating three of the six sealing arms and the second stage may comprise actuating the remaining three. More generally, the method may comprise actuating a first plurality of sealing heads to seal the sheath and plug at the first plurality of seal regions and actuating a second plurality of sealing heads to seal the sheath and plug at the second plurality of seal regions. The sealing heads may each be offset from one another in a circumferential direction. The sealing heads may be radially movable toward and away from one another, and may be movable independently of one another.
Accordingly, the method described herein may comprise a method of heat sealing at least of a protective sheath of a device to at least part of a plug of a device.
According to another example, there is provided a heat sealing apparatus for use in a method of manufacturing (at least part of) a device (at least part of which is suitable) for insertion into a vaginal or rectal cavity, for example the device as described above. The device may therefore comprise a plug configured to be worn inside the vaginal or rectal cavity and a protective sheath configured to accommodate at least part of the plug. The sealing apparatus may comprising a sealing head configured to heat seal at least part of the protective sheath to at least part of a first end of the plug, and a controller configured to cause the heat seal to at least one of: heat seal at a temperature of between 100 and 200°C, heat seal at a pressure of between 3 and 7 bar, and heat seal for a duration of between 0.5 and 4 seconds, to heat seal part of the protective sheath to the first end of the plug. In other words the controller may be configured to cause the heat seal to apply a temperature of between 100 and 200°C to an overlapping area of the sheath and plug; cause the heat seal to apply a pressure of between 3 and 7 bar to an overlapping area of the sheath and plug; and cause the heat seal to apply a temperature and/or a pressure to an overlapping area of the sheath and plug for between 0.5 and 4 seconds.
The controller may be configured to cause the head to at least one of: heat seal at a temperature of between 110°C, heat seal at a pressure of between 5.5 and 6.5 bar (e.g. 6 bar), and heat seal at a duration of between 2 and 3 seconds (e.g. 2.5 seconds), to heat seal part of the protective sheath to the first end of the plug. In other words the controller may be configured to cause the heat seal to apply a temperature of 110°C to an overlapping area of the sheath and plug; cause the heat seal to apply a pressure of between 5.5 and 6.5 bar (e.g. 6 bar) to an overlapping area of the sheath and plug; and cause the heat seal to apply a temperature and/or a pressure to an overlapping area of the sheath and plug for between 2 and 3 seconds (e.g. 2.5 seconds).
The, or each, head may comprise a polytetrafluoroethylene (PTFE) coating. The coating may comprise a Teflon coating. The coating may comprise Impreglon XP1301 in some examples. This may result in more efficient heat transfer which, in turn, may allow for a reduced heat seal temperature and/or cycle time during production. This may also give a more consistent and improved heat seal when compared with other coatings.
The heat sealing apparatus may further comprise a control unit for controlling the actuation of the sealing head.
The head may comprise a curved surface, sometimes referred to as a “radiused edge”. The sealing head may comprise a sealing surface having a curvature substantially conforming to the curvature of the plug. In this way, when the sealing surface exerts a force against the absorbent plug (to seal part of the sheath to the plug) deformation of the plug will be minimised, and the chance of perforations forming in the heat seal will be reduced. In some examples, the curved surface may therefore be configured to conform to an outer profile of the plug.
The controller may be configured to cause the head to heat seal part of the protective sheath to the first end of the plug along at least 20% of an axial length of the plug. In other words, the controller may be configured to cause the sealing head of the sealing apparatus to exert a sealing force along 20% of the axial length of the plug.
The head may comprise a first and second plurality of head portions, wherein the first plurality is independently actuatable from the second plurality. The controller may be configured to cause the first plurality of head portions to heat seal a first region of the protective sheath to a first region of the plug at a first seal region and to cause the second plurality of head portions to heat seal a second region of the protective sheath to a second region of the plug at a second seal region, the first and second seal regions being offset around the exterior surface of the plug from the first plurality of seal regions.
The heat seal regions may be configured to overlap. This may ensure a heat seal is provided substantially around the entire exterior surface of the plug by accounting for manufacturing tolerances.
The apparatus may comprise six head portions. The first and second plurality of head portions may each comprise three head portions.
According to another example herein there is provided a sealing apparatus for use in a method of manufacturing (at least part of) a device (e.g. as described above) comprising a plug configured to be worn inside a vaginal or rectal cavity and a protective sheath configured to accommodate at least part of the plug, the apparatus comprising: a first plurality of heads and second plurality of heads, wherein the first plurality is independently actuatable from the second plurality. The first and second plurality of sealing heads may be circumferentially offset from one another and radially movable towards and away from one another. The first plurality of heads may be concurrently actuatable, e.g. actuatable in tandem. The second plurality of heads may be concurrently actuatable, e.g. actuatable in tandem.
According to another example herein there is provided a non-transitory machine readable medium having a set of instructions stored thereon such that, when executed by a processor of a heat sealing machine, the instructions are to cause a sealing surface of the heat sealing machine to apply a pressure and temperature, for a duration, to at least part of a protective sheath of a device for insertion into a vaginal or rectal cavity to a first end of a plug of a device for insertion into a vaginal or rectal cavity to heat seal the sheath to the plug, wherein the instructions are to cause the sealing surface to at least one of: apply a temperature of between 100 and 200°C, apply a pressure of between 3 and 7 bar, apply a temperature and pressure for a duration of between 0.5 and 4 seconds.
Accordingly, the conditions for heat sealing according to the method, apparatus, or instructions described above may comprise a temperature of greater than 106 °C, e.g. at least 107 °C. In one example, the temperature may be between 100 and 200°C. In yet another example the temperature may be between 105 and 120 °C. In yet another example the temperature may be 110 °C. The conditions may comprise a pressure of between 3 and 7 bar. In one example, the pressure may be between 5.5 and 6.5 bar. In yet another example the pressure may be 6 bar. In one example the time duration that the temperature and pressure is applied for to effect the heat seal may be between 0.5 and 4 seconds. In another example the duration may be between 2 and 3 seconds. In yet another example the duration may be 2.5 seconds.
Brief Description of Drawings
Embodiments will now be described by way of example only, with reference to the Figures, in which:
Figure 1 schematically shows a perspective view of an apparatus according to the invention in a load position;
Figures 2 and 3 schematically show a device for insertion into a vaginal or rectal cavity which may be manufactured using the apparatus of Figures 1-4; Figure 4 schematically shows a perspective view of the apparatus of Figure 1 in a first heat seal position;
Figure 5 schematically shows a perspective view of the apparatus of Figures 1 and 2 in a second heat seal position;
Figure 6 schematically shows a plan view of the apparatus of Figure 1 ; and Figure 7 shows the steps of an exemplary method of using the apparatus of Figures
1-4.
Detailed Description
Figure 1 shows a sealing apparatus 10 comprising a plurality of sealing heads 12, 14, 16, 18, 20, 22. The sealing heads are each evenly, and circumferentially, spaced around a central region 24. The central region 24 is for receipt of a plug of a device. In this example, 6 heads are provided, offset by 60°, about the central region 24 but in other examples a different number of heads may be provided and may be offset by a different angle. Indeed, any number of heads (including 1) may be provided according to this disclosure. Each of the heads 12, 14, 16, 18, 20, 22 is linearly, or translatably, movable in a radial direction, i.e. towards and away from the central region 24, and towards and away from one another, by an actuator disposed on each head. In another example, a single actuator may actuate the movement of all heads. The actuation of each head 12, 14, 16, 18, 20 may be controlled by a controller 28, for example the controller may operate on instructions that are to cause the movement of the sealing heads. The controller 28 is configured to control the heat sealing conditions of the apparatus 10, such as temperature, pressure, and time. For example, the controller 28 is configured to control the apparatus 10 so as to heat seal a region of a sheath to a region of a plug (as will be described below) at a temperature of between 100 and 200°C (e.g. between 105 and 120 °C, for example 110°C), at a pressure of between 3 and 7 bar (e.g. between5.5 and 6.5 bar, for example 6 bar), for a duration of between 0.5 and 4 seconds (e.g. between 2 and 3 seconds, for example 2.5 seconds). For example, each sealing head may comprise a heating element and the controller may be to control the actuating and/or temperature of the heating element. For example, the controller may be to control the heating element such that the target pressure is applied to the sheath and plug by a sealing surface of each sealing head. For example, the controller may be configured to control the movement of each sealing head so that the target pressure is applied to the sheath and plug by the sealing surface of each sealing head. The apparatus 10 may be used in a process to manufacture a device.
Figure 2 shows an example device 50, in this example a 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 absorbent plug 52 is substantially cylindrical and has an axial length L and a radius R. 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, and is to assist in removal of the absorbent plug 52 from the cavity. In the Figure 2 example, the cord 58 comprises two strands of string 60, 62 joined together by a knot 66 to form a loop 64 of material, but in other examples the cord 58 may comprise a single strand. The absorbent pad 52 and the sheath 56 can be inverted over the absorbent plug 52. This configuration of the device is shown in Figure 3. It 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.
Figure 3 shows a heat sealed region 68, or weld region, formed by the sheath 56 and absorbent plug 52 in a region opposite the join of the sheath 56 to the pad 54. The heat seal region 68 may be formed using the apparatus 10 as shown in Figure 1 , as will be described below with reference to Figures 4 and 5.
The sheath 56 may comprise a flexible plastics material and may be radially expandable. The absorbent plug 52 is made from compressed cotton or such like. The cord 58 may extend through the sheath 56, and movement of the cord may cause the plug 52 to move. For example, pulling the cord 58 may create a tension in the cord that causes the plug 52 to move. Pulling the cord on the device 50, in its Figure 2 configuration, may cause the plug 52 to advance towards the pad 54, through the sheath 56, and through an opening in the pad 54 and may cause the device to be in the “inverted” configuration shown in Figure 3. This configuration is referred to as “inverted” since the exterior surface of the sleeve of the sheath in Figure 3 is on the interior of the sheath when the device is in the configuration shown in Figure 2. Referring again to Figure 1 , the heads 12, 14, 16, 18, 20, 22 comprise a first plurality of heads 12, 16, 20 and a second plurality of heads 14, 18, 22. The first plurality of heads 12, 16, 20 are configured to be actuatable concurrently, e.g. in tandem with one another. The second plurality of heads 14, 18, 22 are configured to be actuatable concurrently, e.g. in tandem with one another. However, the first and second pluralities of heads are independently actuatable from one another. In this way, the heat sealing can take place in two stages. Accordingly, in a first weld stage, the first plurality of heads 12, 16, 20 are moved into engagement with the sheath and plug of a device that is placed in the central region 24 to apply a pressure and temperature to the plug and sheath to heat seal the plug and sheath in a first plurality of sealing regions. In a second stage, the second plurality of heads 14, 18, 22 are moved into engagement with the sheath and plug of a device that is placed in the central region 24 to apply a pressure and temperature to the plug and sheath to heat seal the plug and sheath in a second plurality of sealing regions. The first and second pluralities of heads are offset in a circumferential region and, accordingly, the first and second sealing regions are offset in a circumferential region. However, adjacent portions of the first and second sealing regions may overlap.
Figures 4 and 5, respectively, show the apparatus in the first and second sealing stages.
Figure 4 shows the first plurality of sealing heads 12, 16, 20 moved into sealing engagement with a plug 52 and a sheath 56 of a device. It will therefore be appreciated that, prior to movement of any of the sealing heads of the apparatus, a portion of a device comprising at least a sheath and plug may be placed in the central area 24 of the apparatus such that the sheath at least partially surrounds the plug, or, put another way, such that the plug is at least partially surrounded by the sheath. In other words, part of the sheath abuts part of the plug. This configuration ensures that when a sealing head exerts a sealing force against the plug and sheath, that part of the plug is sealed to part of the sheath.
Accordingly, in Figure 4, the apparatus is shown sealing the plug and sheath at a first plurality of sealing regions, each sealing region corresponding to a respective sealing head 12, 16, 20 (having a heating element therein for generating a target pressure to seal the sheath and plug).
In Figure 5, the apparatus is shown sealing the plug and sheath at a second plurality of sealing regions, each sealing region corresponding to a respective sealing head 14, 18, 22 (having a heating element therein for generating a target pressure to seal the sheath and plug). It will be appreciated that some of the sealing regions may overlap. The degree of overlap will depend, at least in part, on the circumferential spacing of the sealing heads. Each sealing head may comprise a curved sealing surface whose curvature substantially conforms to the curvature of the exterior surface of the plug 52. Each sealing head may therefore comprise an arcuate surface. The radius (of curvature) of the or each sealing surface may be approximately 2mm. This size ensures that the shape of the sealing head conforms to the outer surface of the plug.
Figure 6 shows a plan view of the apparatus 10 surrounding an absorbent plug 52 to be heat sealed, the heads 12, 14, 16, 18, 20, 22. Figure 6 shows the curved sealing surface, one of which is labelled 30, of each sealing head. Accordingly, each sealing head comprises a sealing surface configured to apply heat to an object to be sealed, and in this example the sealing surface comprises a curved surface. In this example, the surface of each sealing surface comprises substantially a portion of a circumference of a circle. In this example, the surface of each sealing portion comprises slightly more than a sixth of a circumference of a circle, there being six sealing heads in this example, such that overlap is formed between the seal regions formed by the first and second plurality of heads. In other examples with six sealing heads, the surface of each sealing portion comprises a sixth of a circumference of a circle such that there is no overlap between the seal regions formed by the first and second plurality of heads. In this example, the curved surface of each sealing portion may comprise less than a sixth of a circumference of a circle.
When actuated together, the first plurality of heads 12, 16, 20 may substantially surround the whole circumference of the device 50 to be heat sealed (as shown in Figure 4). When actuated together, the second plurality of heads 14, 18, 22 may substantially surround the whole circumference of the device 50 to be heat sealed (as shown in Figure 5). The depth of the contact surface, in a direction along the length of the device 50 to be heat sealed, is such that the resultant heat seal has a depth of substantially 20% of the length of the absorbent plug 52. The height of the contact surface, or sealing surface, of each head will correspond to the depth of the seal (or weld). Each of the heads 12, 14, 16, 18, 20, 22 may comprise a polytetrafluoroethylene coating, so as to provide improved heat transfer to the device 50 during heat sealing.
Figure 7 shows a method 100 of manufacturing at least part of a device, for example the device 50 as described above, using the apparatus of Figures 1, and 4-6. In a first step 102, an unwelded device 50 (e.g., as shown in Figure 3), comprising an absorbent plug 52, surrounded by a protective sheath 56, is placed into the central region 24 of the apparatus 10. This may be performed manually, or automatically, e.g. by at least one automated arm. The cord 58 of the device may be withdrawn into a recess in the central region 24, using suction, such that it is removed out of the plane of the heads 12, 14, 16, 18, 20, 22. In other words, a controller may be configured to create a suction force so as to draw the cord of the device into a recess of the apparatus. The automated arms hold the device 50 in position during the heat sealing steps.
In a second step 104, the first plurality of heads 12, 16, 20 are actuated to move towards an exert a sealing force on the device 50 (to the position as shown in Figure 4) and, in example, apply a pressure of between 0.55 at a temperature of approximately 110 °C, for a duration of between 2-3 seconds, so as to heat seal the sheath 56 to the plug 52.
In a third step 106, the first plurality of heads 12, 16, 20 are actuated away from the device 50, and the second plurality of heads 14, 18, 22 are actuated towards the device 50. In one example, the second plurality of heads 14, 18, 22 apply a pressure of between 0.55 at a temperature of approximately 110 °C, for a duration of between 2-3 seconds, so as to heat seal the sheath 56 to the plug 52. In this way, the heat seal is formed in two steps, which ensures that the sheath 56 is sealed to the plug 52 at substantially the entire circumference of the plug.
The resultant heat seal can be characterized by two strength properties- a peel-back force and a separation force. The peel-back force is defined as an initial pull force required to separate the heat sealed sheath 56 from the circumferential surface of the absorbent plug 52. Using a Mecmesin AFG 500N Force gauge, the peel-back force of a heat seal as formed above may be approximately 2N/15mm. That is, manual testing of the heat seal may apply a force of 4N (in a so called “weld test”). The target peel-back force is approximately 2N per segment of the outer circumferential surface of the plug, in one example 2N per 15mm of the circumference of the plug. The separation force is a pull force required to completely separate the sheath from the absorbent plug. The separation force is typically higher than the peel back force as exposed fibres in an end region of the absorbent plug bond strongly with the sheath during heat sealing. Again, using a Mecmesin AFG 500N Force gauge, the separation force of a heat seal as formed above is 0.6kg.
In a next step 108, the second plurality of heads 14, 18, 22 are actuated away from the device 50, and the automated arms move the device 50 on to a packaging process. The process described by the method of Figure 7 may be performed after a process of joining the sheath to the plug (e.g. at the cord of the plug). Although a plurality of sealing heads are described and depicted it is emphasized that an apparatus with a single head is within the scope of this disclosure, the sealing head being actuatable or controllable, to produce a temperature and pressure as described above. In this example, the sheath may be sealed to the plug in a single sealing region or at least one of the sealing head or device may be moved, e.g. rotated, in order to effect sealing in a plurality of sealing regions.
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 of manufacturing a device for insertion into a vaginal or rectal cavity, the method comprising: providing a plug configured to be worn inside the cavity; providing a protective sheath configured to accommodate at least part of the plug; heat sealing at least part of the protective sheath to a first end of the plug by at least one of: heat sealing at a temperature of between 100 and 200°C, heat sealing at a pressure of between 3 and 7 bar, and heat sealing for a duration of between 0.5 and 4 seconds.
2. A method according to claim 1, wherein heat sealing at least part of the protective sheath to a first end of the plug comprises at least one of: heat sealing at a temperature of between 105 and 120°C or approximately 110 °C, heat sealing at a pressure of between 5.5 and 6.5 bar, or approximately 6 bar, and heat sealing for a duration of between 2-3 seconds or approximately 2.5 seconds.
3. A method according to claim 1 or 2, wherein at least part of the protective sheath is heat sealed to the first end of the plug such that the completed seal has a peel-back force of at least 2N per 15mm outer circumference of the plug.
4. A method according to any of claims 1-3, wherein at least part of the protective sheath is heat sealed to the first end of the plug such that the completed seal has a separation force of at least 0.4kg, optionally at least 0.6kg.
5. A method according to any of claims 1-4, wherein the plug has an axial length, and wherein at least part of the protective sheath is heat sealed to the first end of the plug such that the heat sealing extends along at least 20% of the axial length of the plug.
6. A method according to any of claims 1-5, wherein heat sealing at least part of the protective sheath to a first end of the plug comprises heat sealing at a plurality of seal regions, the seal regions being offset from one another around an exterior surface of the plug.
7. A method according to any of claims 1-6, wherein heat sealing at least part of the protective sheath to a first end of the plug comprises heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions, the second plurality of seal regions being offset around the exterior surface of the absorbent plug from the first plurality of seal regions.
8. A method according to claim 7, wherein the first and second pluralities of seal regions each comprise 3 seal regions.
9. A method according to any preceding claim, wherein the plug of the device comprises an absorbent plug.
10. A method according to any preceding claim, wherein the device is a sanitary product for insertion into a vagina.
11. A method of manufacturing a device for insertion into a vaginal or rectal cavity, the method comprising: providing an plug configured to be worn inside the cavity; providing a protective sheath configured to accommodate at least part of the plug; heat sealing, in a first seal stage, at a first plurality of seal regions, and heat sealing, in a second seal stage, at a second plurality of seal regions, the second plurality of seal regions being offset around the exterior surface of the plug from the first plurality of seal regions.
12. A heat sealing apparatus for use in a method of manufacturing a device for insertion into a vaginal or rectal cavity , the device comprising a plug configured to be worn inside the cavity and a protective sheath configured to accommodate at least part of the plug, the apparatus comprising: a head configured to heat seal at least part of the protective sheath to a first end of the plug, and a controller configured to cause the heat seal to at least one of: heat seal at a temperature of between 100 and 200°C, heat seal at a pressure of between 3 and 7 bar, and heat seal for a duration of between 0.5 and 4 seconds, to heat seal part of the protective sheath to the first end of the plug.
13. A heat sealing apparatus according to claim 12, wherein the controller is configured to cause the head to at least one of: heat seal at a temperature of between 105 and 120°C, or approximately 110°C, heat seal at a pressure of between 5.5 and 6.5 bar, or approximately 6 bar, and heat seal at a duration of between 2 and 3 seconds, or approximately 2.5 seconds, to heat seal part of the protective sheath to the first end of the plug.
14. A heat sealing apparatus according to claim 12 or 13, wherein the head comprises a polytetrafluoroethylene (PTFE) coating.
15. A heat sealing apparatus according to any of claims 12-14, wherein the heat sealing apparatus further comprises a control unit for controlling the actuation of the head.
16. A heat sealing apparatus according to any of claims 12-15, wherein the head comprises a curved surface.
17. A heat sealing apparatus according to claim 16, wherein the curved surface is configured to conform to an outer profile of the plug.
18. A heat sealing apparatus according to any of claims 12-17, wherein the controller is configured to cause the head to heat seal part of the protective sheath to the first end of the plug along at least 20% of an axial length of the plug.
19. A heat sealing apparatus according to any of claims 12-18, wherein the head comprises a first and second plurality of head portions, wherein the first plurality is independently actuatable from the second plurality.
20. A heat sealing apparatus according to claim 19, wherein the controller is configured to cause the first plurality of head portions to heat seal a first region of the protective sheath to a first region of the plug at a first seal region and to cause the second plurality of head portions to heat seal a second region of the protective sheath to a second region of the plug at a second seal region, the first and second seal regions being offset around the exterior surface of the plug from the first plurality of seal regions.
21. A heat sealing apparatus according to any of claims 12-20, wherein the apparatus comprises six head portions.
22. A heat sealing apparatus according to claim 21 when dependent upon claim 18, wherein the first and second plurality of head portions each comprise three head portions.
23. A heat sealing apparatus for use in a method of manufacturing a device for insertion into a vaginal or rectal cavity, the device comprising an plug configured to be worn inside the cavity and a protective sheath configured to accommodate at least part of the plug, the apparatus comprising: a first plurality of heads and second plurality of heads, wherein the first plurality is independently actuatable from the second plurality.
24. A non-transitory machine readable medium having a set of instructions stored thereon such that, when executed by a processor of a heat sealing machine, the instructions are to cause the heat sealing machine to: heat seal at least part of a protective sheath of a device for insertion into a vaginal or rectal cavity to a first end of an plug of a device for insertion into a vaginal or rectal cavity at least one of: a temperature of between 100 and 200°C, a pressure of between 3 and 7 bar, for a duration of between 0.5 and 4 seconds.
PCT/EP2020/086005 2019-12-16 2020-12-14 Devices for insertion into a vaginal or rectal cavity WO2021122467A1 (en)

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GB1918526.3 2019-12-16
GB1918526.3A GB2590903B (en) 2019-12-16 2019-12-16 Devices for insertion into a vaginal or rectal cavity

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JPS62298356A (en) * 1986-06-18 1987-12-25 ジェクス株式会社 Sanitary tampon
EP0903137A1 (en) * 1997-09-19 1999-03-24 Hauni Richmond, Inc. Tampon and methods of making the same
US20100170069A1 (en) * 2004-05-14 2010-07-08 Curt Binner Intravaginal device with fluid transport plates

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US4743237A (en) * 1986-12-18 1988-05-10 Kimberly-Clark Corporation Container having securely-attached handling cord and method and apparatus for producing the container
SE508451C2 (en) * 1992-12-30 1998-10-05 Sca Hygiene Prod Ab Menstrual tampon and way to produce the same

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US3791902A (en) * 1971-11-12 1974-02-12 Kimberly Clark Co Method for coating tampons with water-soluble film
JPS62298356A (en) * 1986-06-18 1987-12-25 ジェクス株式会社 Sanitary tampon
EP0903137A1 (en) * 1997-09-19 1999-03-24 Hauni Richmond, Inc. Tampon and methods of making the same
US20100170069A1 (en) * 2004-05-14 2010-07-08 Curt Binner Intravaginal device with fluid transport plates

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EP4090517A1 (en) 2022-11-23
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GB201918526D0 (en) 2020-01-29

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