EP4606540A1 - Tooling for cutting of elastomeric components - Google Patents

Tooling for cutting of elastomeric components

Info

Publication number
EP4606540A1
EP4606540A1 EP24305286.7A EP24305286A EP4606540A1 EP 4606540 A1 EP4606540 A1 EP 4606540A1 EP 24305286 A EP24305286 A EP 24305286A EP 4606540 A1 EP4606540 A1 EP 4606540A1
Authority
EP
European Patent Office
Prior art keywords
insert
component
elastomeric
cutting tool
cutting
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP24305286.7A
Other languages
German (de)
French (fr)
Inventor
Coralie VOIRIN
Eloïse PERRIN
Julien GAGLIANO
Nestor RODRIQUEZ SAN JUAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson France SA
Becton Dickinson and Co
Original Assignee
Becton Dickinson France SA
Becton Dickinson and Co
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 Becton Dickinson France SA, Becton Dickinson and Co filed Critical Becton Dickinson France SA
Priority to EP24305286.7A priority Critical patent/EP4606540A1/en
Priority to PCT/US2025/016293 priority patent/WO2025178865A1/en
Publication of EP4606540A1 publication Critical patent/EP4606540A1/en
Pending legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B26HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26DCUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D1/00Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor
    • B26D1/01Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which does not travel with the work
    • B26D1/04Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which does not travel with the work having a linearly-movable cutting member
    • B26D1/06Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which does not travel with the work having a linearly-movable cutting member wherein the cutting member reciprocates
    • B26D1/08Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which does not travel with the work having a linearly-movable cutting member wherein the cutting member reciprocates of the guillotine type
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B26HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26DCUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D3/00Cutting work characterised by the nature of the cut made; Apparatus therefor
    • B26D3/003Cutting work characterised by the nature of the cut made; Apparatus therefor specially adapted for cutting rubber
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B26HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26DCUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D3/00Cutting work characterised by the nature of the cut made; Apparatus therefor
    • B26D3/16Cutting rods or tubes transversely
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B26HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26DCUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D7/00Details of apparatus for cutting, cutting-out, stamping-out, punching, perforating, or severing by means other than cutting
    • B26D7/01Means for holding or positioning work
    • B26D2007/013Means for holding or positioning work the work being tubes, rods or logs

Definitions

  • the present disclosure relates generally to cutting tools and, more particularly, to cutting tools employed for cutting elastomeric components, such as stoppers or needle tip caps in a syringe or other medical injection device.
  • Syringes are used in a variety of environments for administering fluids, such as medications or other drugs, to a patient.
  • a syringe will typically include a glass (or plastic) syringe barrel with an opening at a distal end and a plunger assembly inserted through the opposite proximal end of the barrel.
  • the distal end of the syringe barrel may include a tip through which the opening is formed.
  • the tip may be configured as a luer connection that enables a transfer of fluid out from or into the syringe barrel, while in other embodiments the tip may be configured as a hub that retains a needle therein for the syringe.
  • the plunger assembly typically includes an elongated plunger rod extending out of the barrel and a plunger head or stopper disposed at the distal end of the plunger rod.
  • the stopper is typically made of elastomeric material and is adapted to ensure the container closure integrity of a syringe when the stopper is inserted into the syringe.
  • the plunger assembly is movable within the syringe barrel to force fluid out from an inner volume of the syringe barrel and/or to aspirate fluid into the inner volume of the syringe barrel - with the stopper sliding through the barrel when the plunger assembly is actuated by a user.
  • a rigid tip cap or needle shield is typically included on the syringe to maintain sterility of the syringe tip.
  • the syringe tip may be configured to include a connector thereof (e.g., luer connector), with a rigid tip cap provided to cover the connector.
  • the syringe tip may be configured to include a needle, with a needle shield provided that may be composed of a rigid outer casing that provides structure to the needle shield and a compliant inner casing or "jupe" that surrounds the needle.
  • components of the syringe - including elastomeric components such as the stopper and/or needle shield - may undergo materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe.
  • materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe.
  • it may be required to perform an initial cutting of a component in order to provide a suitable specimen for testing.
  • an elastomeric stopper may need to be cut in cross-section by a cutting tool to specified dimensions (e.g., width, thickness, etc.) to provide for testing thereof.
  • the cutting tool includes a fixed base having a first end and a second end, with the fixed base comprising a grip positioned at the first end, an insert holder positioned at the second end and including a lower support platform and an engagement feature extending upward from the lower support platform, and a guard positioned between the grip and the insert holder, the guard extending upwardly from the grip and the insert holder.
  • the cutting tool also includes an insert engageable with the insert holder and configured to retain an elastomeric component therein, with the insert comprising a flange configured to mate with the engagement feature to secure the insert to the fixed base and a main body joined with the flange and spaced apart therefrom toward the second end, the main body comprising a slot formed orthogonal to the fixed base and in a top surface of the main body and extending downwardly through a portion of the main body, and a component receptacle configured to receive and retain the elastomeric component therein, with the component receptacle intersected by the slot.
  • the cutting tool further includes a cutting blade insertable within the slot and configured to cut the elastomeric component retained within the component receptacle.
  • the slot intersects with the component receptacle such that the cutting blade is positioned to cut the elastomeric component in cross-section.
  • the insert comprises a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  • the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a first orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a first direction.
  • the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a second orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a second direction, as a non-limiting orientation.
  • the insert comprises a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein, the syringe tip cap including an elastomeric inner cap portion.
  • the second component receptacle is configured to receive and retain the syringe tip cap in a first orientation, such that the syringe tip cap is cut in cross-section in a first direction.
  • the second component receptacle is configured to receive and retain the syringe tip cap in a second orientation, such that the syringe tip cap is cut in cross-section in a second direction, as a non-limiting orientation.
  • an entirety of the insert is positioned on a top surface of the lower support platform.
  • the engagement feature comprises a box-shaped receptacle therein having an open top end, and wherein the flange of the insert slides down into the box-shaped receptacle to secure the insert to the fixed base.
  • the fixed base comprises a flat bottom surface including a plurality of anti-skid pads thereon.
  • the cutting tool further includes a blade actuator configured to advance the cutting blade into the slot.
  • the method includes attaching the insert to the insert holder by engaging the flange with the engagement feature, placing the elastomeric component into the component receptacle, and actuating the cutting blade so as to advance the cutting blade into the slot, thereby cutting the elastomeric component.
  • attaching the insert comprises attaching a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  • attaching the insert comprises attaching a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein.
  • At least one of is synonymous with "one or more of'.
  • the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C.
  • "at least one of A, B, and C" includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.
  • the present invention is directed to a cutting tool for the cutting of components formed of an elastomeric material (e.g., rubber), to provide for subsequent materials testing of the component. While specific examples are provided herein of a cutting tool configured to cut elastomeric components included in a medical injection device (e.g., a syringe), it is recognized that the cutting tool could be used to cut other elastomeric components not associated with a medical injection device, and thus the specific examples provided below are not meant to limit the scope of the disclosure.
  • a medical injection device e.g., a syringe
  • FIGS. 1 and 2 shown is a non-limiting embodiment of a medical injection device 10, such as a syringe for example, with which aspects or embodiments of the disclosure may be implemented. While the medical injection device is shown and described hereafter as a syringe 10, it is recognized that other medical injection devices may incorporate aspects of the disclosure, as described in detail here below.
  • a medical injection device such as a syringe for example, with which aspects or embodiments of the disclosure may be implemented. While the medical injection device is shown and described hereafter as a syringe 10, it is recognized that other medical injection devices may incorporate aspects of the disclosure, as described in detail here below.
  • the proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate handling and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 with respect to the plunger assembly 14 during medication administration.
  • the end member 18 may include a shoulder 28 which narrows with respect to the cylindrical outer wall 16, as well as a hub portion 30 extending out distally from shoulder 28.
  • the hub portion 30 is formed as a partially hollow member that defines a channel 32 therethrough in fluid communication with the chamber 20.
  • a needle 34 is attached to the hub portion 30 within channel 32, such as by being glued or otherwise secured to the hub portion 30.
  • - rather than needle 34 - syringe 10 could instead include a luer connection formed at the distal end 24 of syringe barrel 12 that enables the syringe 10 to be directly coupled to a luer connection of an associated medical device or component, to provide for the direct transfer of fluids therebetween.
  • the plunger assembly 14 of syringe 10 is formed of an elongate plunger rod 36 (more generally "plunger 36," as used hereafter) and a plunger head or stopper 38.
  • the plunger 36 may include a main body 40 extending between a plunger proximal end 42 and a plunger distal end 44.
  • the main body 40 may include a plurality of elongate vanes or walls 46 extending axially along a length thereof between the plunger proximal end 42 and the plunger distal end 44.
  • a thumb press 48 is positioned at the plunger proximal end 42 that may be engaged by a thumb (or other finger) of the user to apply a distally directed force to the plunger assembly 14 to move the plunger 36 with respect to the syringe barrel 12.
  • a flanged extension member 50 e.g., disc-shaped flange
  • the plunger distal end 44 may include a female receptacle formed therein that is configured to receive and connect to a protrusion (e.g., pin) extending out proximally from the stopper, with the protrusion and receptacle engaging via threading, for example.
  • the stopper 38 includes a receptacle (not shown) formed therein that is sized and configured to receive the flanged extension member 50 of plunger 36, with the flanged extension member 50 coupling with the receptacle via a press fit connection, for example, to secure the stopper 38 to the plunger 36, although it can be appreciated that the stopper 38 and plunger distal end 44 can be secured by other techniques known in the art.
  • syringe 10 further includes a tip cap 60 that may be coupled to the hub portion 30 of syringe barrel 12. While shown in FIGS. 1 and 2 as a needle shield that is used to protect the needle 34, tip cap 60 could instead be configured as a cap that covers a luer connection. In embodiments where the tip cap 60 is configured as a needle shield, the tip cap 60 may be composed of a rigid outer casing 62 that provides structure to the tip cap 60 and a compliant inner casing 64 that surrounds the needle 34 (when needle shield 60 is coupled to syringe barrel 12).
  • the outer casing 62 may be made of a rigid material, while the inner casing 64 is made of a deformable or elastomeric material (e.g., rubber).
  • the tip cap 60 may be composed of only a rigid material.
  • elastomeric components of the syringe 10 - such as the stopper 38 and/or tip cap 60 (with elastomeric inner casing 64) - may undergo materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe 10.
  • materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe 10.
  • the cutting tool 70 generally includes a fixed base 72, an insert 74 (selected from a number of inserts) configured to retain an elastomeric component therein, and a cutting blade 76 for cutting the elastomeric component.
  • the fixed base 72 of cutting tool 70 is configured as an elongate structure having a first end 78 and a second end 80.
  • a grip 82 is positioned at the first end 78 of the fixed base 72 that enables a user to grasp and secure the cutting tool 70 during use thereof.
  • the grip 82 may have a rounded top surface 84 that is ergonomically designed to enable grasping thereof by a user.
  • An insert holder 86 is positioned at the second end 80 of the fixed base 72 that is configured to receive a removable insert 74, as explained in further detail below. As best shown in FIG.
  • the insert holder 86 includes a lower support platform 88 on which the insert 74 may be positioned, along with an engagement feature 90 extending upward from the lower support platform 88 and that mates with the insert 74 to secure the insert 74 to the fixed base 72.
  • the lower support platform 88 may present a planar top surface 92 on which the insert 74 rests when engaged with the fixed base 72.
  • a profile (i.e., outer perimeter) of the lower support platform 88 generally corresponds in shape to a shape of the insert 74, such that the lower support platform 88 supports an entirety of the insert 74.
  • the engagement feature 90 of insert holder 86 may be configured as a generally box-shaped receptacle ("box-shaped receptacle 90") therein shaped to accommodate a portion of the insert 74 therein.
  • the receptacle 90 may have an open top end 92 that provides for sliding engagement of the insert 74 with the receptacle.
  • the fixed base 72 of cutting tool 70 also includes a guard feature 94 that is positioned between the grip 82 and the insert holder 86.
  • the guard 94 extends upwardly from the grip 82 and the insert holder 86, so as to separate the grip 82 from the insert holder 86 and present a barrier there between.
  • the guard 94 may be structured as a flange that extends up past the grip 82 of fixed base 72 and may have a shape that generally corresponds to the shape of the top surface of grip 82.
  • the guard 94 may have a rounded top edge or profile that generally matches a rounded top surface 84 of grip 82.
  • a bottom surface 96 of the fixed base 72 may include a plurality of anti-skid pads 98 thereon that are dispersed about a perimeter of the fixed base 72.
  • the anti-skid pads 98 may be composed of rubber or another suitable material that provides a high coefficient of friction between the fixed base 72 and a surface on which the cutting tool 70 is placed. The anti-skid pads 98 may thus help to prevent movement of the cutting tool 70 during use thereof.
  • the insert 74 of cutting tool 70 is provided as a separate component from the fixed base 72 that may be selectively added thereto and/or removed therefrom.
  • the insert 74 is formed of a metallic material that resists wear during operation of the cutting tool 70 (and contact between the cutting blade 76 and the insert 74).
  • the insert 74 is engageable with the insert holder 86 and is configured to retain an elastomeric component therein, so as to enable cutting of the component.
  • the insert 74 may be characterized as generally including a main body 102 and a flange 104 - with the flange 104 spaced apart longitudinally from the main body 102 (toward the first end 78) and j oined thereto via a connecting portion 106.
  • the flange 104 of insert 74 is configured to mate with the engagement feature 90 to secure the insert 74 to the fixed base 72.
  • the engagement feature 90 is provided as a box-shaped receptacle 90 as described above
  • the flange 104 may have a rectangular shape configured to be received in the box-shaped receptacle 90 - with the connecting portion 106 of the insert 74 being accommodated by an opening/channel 108 formed in a sidewall 110 of the receptacle.
  • the flange 104 of insert 74 may be slid down into the box-shaped receptacle 90 (through the open top end 92) to secure the insert 74 to the fixed base 72.
  • the main body 102 of insert 74 may comprise a cube-shaped body having a height, H, that matches that of the flange 104, the connecting portion 106, and the box-shaped receptacle 90. As described above, the main body 102 may have a profile/perimeter generally matching that of lower support platform 88, such that an entirety of the main body 102 (and overall insert 74) rests on the platform 88.
  • the main body 102 includes a slot 112 formed therein that extends from a top surface 114 and down through a portion of the height, H, of the main body 102. In some embodiments, the slot 112 may extend down through the main body 102 a majority of the height, H, thereof.
  • the slot 112 is sized and configured to receive the cutting blade 76 therein, with a width of the slot 112 being such that the sides of the blade 76 do not make contact with the main body 102 when the blade is advanced into the slot 112, but with a width of the slot 112 also preventing excess movement/deflection of the blade 76 in the longitudinal direction.
  • the slot 112 is oriented in main body 102 in a direction orthogonal to the longitudinal direction of the fixed base 72 (extending between the first and second ends 78, 80).
  • the slot 112 may extend a full breadth of the main body 102, such that the slot 112 is open on opposed sides of the main body 102.
  • the main body 102 also includes a component receptacle 116 formed therein that is configured to receive and retain the elastomeric component.
  • the component receptacle 116 is formed in the top surface 114 of main body 102 to enable placement of the component therein from a top side of the cutting tool 70.
  • the component receptacle 116 is generally centered on the main body 102 and positioned such that the component receptacle 116 is intersected by the slot 112. With the slot 112 intersecting the component receptacle 116 in this manner, the elastomeric component is retained at a location where the cutting blade 76 acts to cut the elastomeric component in cross-section when advanced into the slot 112.
  • the cutting tool 70 enables the cutting of various types of elastomeric components therein - with inserts 74 of multiple configurations being engageable with the fixed base 72, where each insert 74 may be configured to retain a specific component therein and provide for cutting of the component according to desired specifications (i.e., at a desired width and along a desired cross-sectional cutting line orientation).
  • a cutting tool 70 may be provided that is useable for cutting a variety of different elastomeric components.
  • inserts 74 of many different configurations may be used in the cutting tool 70 - beyond the inserts shown in FIGS. 7 and 8 - including inserts for cutting other elastomeric components of a syringe and elastomeric components used in other devices.
  • FIG. 7 illustrates an insert 74a configured to receive and retain an elastomeric syringe plunger stopper 38 to provide for cutting thereof.
  • the insert 74a includes a flange 104, main body 102, and connecting portion 106 as previously described, with a slot 112 and component receptacle 116 formed in the main body 102.
  • the component receptacle 116 may have a generally rectangular or square profile and may have a rounded (i.e., semi-cylindrical) bottom surface that is configured to receive the stopper 38 therein.
  • the dimensions of the component receptacle 116 may vary depending on the size of the stopper 38 (e.g., for a 1 mL syringe, 5 mL syringe or 10 mL syringe, as non-limiting examples) and/or the orientation in which the stopper 38 is to be positioned therein. That is, the component receptacle 116 may be configured to receive the stopper 38 in a first orientation to enable a cross-sectional cutting thereof in a first direction/dimension or may be configured to receive the stopper 38 in a second orientation to enable a cross-sectional cutting thereof in a second direction/dimension.
  • FIG. 8 illustrates an insert 74b configured to receive and retain a syringe tip cap 60 (including an elastomeric inner casing 64) to provide for cutting thereof.
  • the insert 74b includes a flange 104, main body 102, and connecting portion 106 as previously described, with a slot 112 and component receptacle 116 formed in the main body 102.
  • the component receptacle 116 may have an elongated profile and may have a rounded (i.e., semi-cylindrical) bottom surface that is configured to receive the syringe tip cap 60 therein.
  • the elongated component receptacle 116 may have a first portion having a first diameter and a second portion having a second diameter that is less than the first diameter.
  • the dimensions of the component receptacle 116 may vary depending on the size of the syringe (e.g., for a 1 mL syringe, 5 mL syringe or 10 mL syringe, as non-limiting examples) with which the syringe tip cap 60 is used and/or the orientation in which the syringe tip cap 60 is to be positioned therein.
  • the component receptacle 116 may be configured to receive the syringe tip cap 60 in a first orientation to enable a cross-sectional cutting thereof in a first direction/dimension or may be configured to receive the syringe tip cap 60 in a second orientation to enable a cross-sectional cutting thereof in a second direction/dimension.
  • the cutting blade 76 of cutting tool 70 is shown therein as being configured to be inserted within the slot 112 of insert 74 for cutting of the elastomeric component retained therein.
  • the cutting blade 76 may be configured as a slitter blade with a sharpened front edge 118, although it is recognized that the blade 76 could instead be a circular blade or blade of another suitable configuration.
  • the blade 76 may be formed of a metallic, ceramic, or composite material that is suitable for cutting rubber or another elastomeric material, with the blade 76 being formed of stainless steel, high carbon, solid carbide, ceramic, an aluminum alloy, or beryllium copper, as non-limiting examples.
  • the cutting tool 70 further includes a blade actuator 120 configured to advance the cutting blade 76 into the slot 112.
  • the actuator 120 may comprise a manually drive actuator, such as a handle, that is mechanically connected to the cutting blade 76 and that may be operated by a user to advance the cutting blade 76 into the slot 112 of insert 74 to perform a cutting of the elastomeric component.
  • the actuator 120 may drive the cutting blade 76 in an automated or assisted fashion, with the actuator 120 being provided a hydraulic or pneumatic actuator or as a servo-motor type actuator.
  • the cutting tool 70 as described above may be employed to perform a cutting of an elastomeric component.
  • an insert 74 of a desired configuration is first attached to the fixed base 72 (i.e., to the insert holder 86).
  • the flange 104 on insert 74 may be slid down into an engagement feature 90 (e.g., a box-shaped receptacle 90) of the insert holder 86, to secure the insert 74 to the fixed base 72.
  • a specifically configured insert 74 may be selected that is designed to enable cutting of a desired elastomeric component according to desired specifications (i.e., at a desired width/thickness and along a desired cross-sectional cutting line orientation).
  • an insert 74a having a first configuration may be attached to the fixed base 72 - with the insert 74a having a component receptacle 116 formed in the main body 102 that is configured to receive and retain an elastomeric syringe plunger stopper 38 therein.
  • an insert 74b having a second configuration may be attached to the fixed base 72 - with the insert 74b having a component receptacle 116 formed in the main body 102 that is configured to receive and retain a syringe tip cap 60 (including an elastomeric inner casing 64) therein.
  • an elastomeric component is then placed into the component receptacle 116 of the insert 74.
  • the cutting blade 76 of cutting tool 70 may then be actuated (e.g., manually or via a drive/motor), so as to advance the cutting blade 76 into/through the slot 112 of insert 74, thereby cutting the elastomeric component in cross-section according to a desired profile.
  • the elastomeric component may be removed from the cutting tool 70 and material testing may then be performed on the elastomeric component, such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples.
  • embodiments of the invention thus provide a cutting tool configured to cut elastomeric components (e.g., syringes stoppers or syringe tip caps, as non-limiting examples) according to a desired profile and that provide for subsequent materials testing thereof.
  • the cutting tool is adaptable/configurable to cut multiple different components and to cut a component to a specific width and in different sectional plans, so as to provide flexibility in testing components having different sizes and shapes.
  • the cutting tool provides precise control during cutting and includes ergonomic and safety features thereon, to aid in use of the cutting tool.

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  • Life Sciences & Earth Sciences (AREA)
  • Forests & Forestry (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Provided herein is a cutting tool for cutting an elastomeric component. The cutting tool includes a fixed base having a grip at a first end thereof, an insert holder at a second end thereof having a lower support platform and an engagement feature, and a guard extending upwardly from the grip and the insert holder. The cutting tool also includes an insert engageable with the insert holder and configured to retain an elastomeric component therein, with the insert having a main body and a flange that mates with the engagement feature, with the main body further including a slot formed in a top surface thereof that is orthogonal to the fixed base and a component receptacle intersected by the slot and configured to receive and retain the elastomeric component therein. A cutting blade is insertable within the slot and configured to cut the elastomeric component retained therein.

Description

    BACKGROUND OF THE INVENTION Field of the Invention
  • The present disclosure relates generally to cutting tools and, more particularly, to cutting tools employed for cutting elastomeric components, such as stoppers or needle tip caps in a syringe or other medical injection device.
  • Description of Related Art
  • Syringes are used in a variety of environments for administering fluids, such as medications or other drugs, to a patient. A syringe will typically include a glass (or plastic) syringe barrel with an opening at a distal end and a plunger assembly inserted through the opposite proximal end of the barrel. The distal end of the syringe barrel may include a tip through which the opening is formed. In some embodiments, the tip may be configured as a luer connection that enables a transfer of fluid out from or into the syringe barrel, while in other embodiments the tip may be configured as a hub that retains a needle therein for the syringe. The plunger assembly typically includes an elongated plunger rod extending out of the barrel and a plunger head or stopper disposed at the distal end of the plunger rod. The stopper is typically made of elastomeric material and is adapted to ensure the container closure integrity of a syringe when the stopper is inserted into the syringe. The plunger assembly is movable within the syringe barrel to force fluid out from an inner volume of the syringe barrel and/or to aspirate fluid into the inner volume of the syringe barrel - with the stopper sliding through the barrel when the plunger assembly is actuated by a user.
  • As known in the art, a rigid tip cap or needle shield is typically included on the syringe to maintain sterility of the syringe tip. In some embodiments, the syringe tip may be configured to include a connector thereof (e.g., luer connector), with a rigid tip cap provided to cover the connector. In other embodiments, the syringe tip may be configured to include a needle, with a needle shield provided that may be composed of a rigid outer casing that provides structure to the needle shield and a compliant inner casing or "jupe" that surrounds the needle.
  • With regard to syringes as described above, it is desirable to perform testing on components of the syringe to verify that the components meet manufacturing standards and to compare qualitatively batches. As one example, components of the syringe - including elastomeric components such as the stopper and/or needle shield - may undergo materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe. In performing such testing for certain components of a syringe, it may be required to perform an initial cutting of a component in order to provide a suitable specimen for testing. As one example, an elastomeric stopper may need to be cut in cross-section by a cutting tool to specified dimensions (e.g., width, thickness, etc.) to provide for testing thereof.
  • Accordingly, a need exists in the art for cutting tools that are able to cut syringe components in a manner that provide for subsequent testing thereof. It is desired for such a cutting tool to be adaptable to cutting multiple different components and for the cutting tool to cut a component to a specific width and in different sectional plans, so as to provide flexibility in testing components having different sizes and shapes. It is also desired for the cutting tool to provide precise control during cutting and to include ergonomic and safety features thereon that prevent injury during use, including muscle injuries and tendinitis due to repetitive movements.
  • SUMMARY OF THE INVENTION
  • Provided herein is a cutting tool for cutting an elastomeric component. The cutting tool includes a fixed base having a first end and a second end, with the fixed base comprising a grip positioned at the first end, an insert holder positioned at the second end and including a lower support platform and an engagement feature extending upward from the lower support platform, and a guard positioned between the grip and the insert holder, the guard extending upwardly from the grip and the insert holder. The cutting tool also includes an insert engageable with the insert holder and configured to retain an elastomeric component therein, with the insert comprising a flange configured to mate with the engagement feature to secure the insert to the fixed base and a main body joined with the flange and spaced apart therefrom toward the second end, the main body comprising a slot formed orthogonal to the fixed base and in a top surface of the main body and extending downwardly through a portion of the main body, and a component receptacle configured to receive and retain the elastomeric component therein, with the component receptacle intersected by the slot. The cutting tool further includes a cutting blade insertable within the slot and configured to cut the elastomeric component retained within the component receptacle.
  • In certain configurations, the slot intersects with the component receptacle such that the cutting blade is positioned to cut the elastomeric component in cross-section.
  • In certain configurations, the insert comprises a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  • In certain configurations, the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a first orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a first direction.
  • In certain configurations, the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a second orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a second direction, as a non-limiting orientation.
  • In certain configurations, the insert comprises a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein, the syringe tip cap including an elastomeric inner cap portion.
  • In certain configurations, the second component receptacle is configured to receive and retain the syringe tip cap in a first orientation, such that the syringe tip cap is cut in cross-section in a first direction.
  • In certain configurations, the second component receptacle is configured to receive and retain the syringe tip cap in a second orientation, such that the syringe tip cap is cut in cross-section in a second direction, as a non-limiting orientation.
  • In certain configurations, an entirety of the insert is positioned on a top surface of the lower support platform.
  • In certain configurations, the engagement feature comprises a box-shaped receptacle therein having an open top end, and wherein the flange of the insert slides down into the box-shaped receptacle to secure the insert to the fixed base.
  • In certain configurations, the fixed base comprises a flat bottom surface including a plurality of anti-skid pads thereon.
  • In certain configurations, the cutting tool further includes a blade actuator configured to advance the cutting blade into the slot.
  • Also provided herein is a method for cutting an elastomeric component using the cutting tool as previously described. The method includes attaching the insert to the insert holder by engaging the flange with the engagement feature, placing the elastomeric component into the component receptacle, and actuating the cutting blade so as to advance the cutting blade into the slot, thereby cutting the elastomeric component.
  • In certain configurations, attaching the insert comprises attaching a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  • In certain configurations, attaching the insert comprises attaching a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein.
  • BRIEF DESCRIPTION OF THE DRAWINGS
    • FIG. 1 is a perspective view of a syringe, components of which may be useable with embodiments of the disclosure;
    • FIG. 2 is an exploded view of the syringe of FIG. 1;
    • FIG. 3 is a front perspective view of a cutting tool, in accordance with aspects of the disclosure;
    • FIG. 4 is a top perspective view of the cutting tool of FIG. 3;
    • FIG. 5 is a bottom perspective view of the cutting tool of FIG. 3;
    • FIG. 6 is a perspective view of an insert holder of the cutting tool of FIG. 3;
    • FIG. 7 is a perspective view of an insert of the cutting tool of FIG. 3, in accordance with an aspect of the disclosure; and
    • FIG. 8 is a perspective view of an insert of the cutting tool of FIG. 3, in accordance with another aspect of the disclosure.
    DESCRIPTION OF THE INVENTION
  • The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
  • For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
  • The terms "first", "second", and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
  • As used herein, "at least one of" is synonymous with "one or more of'. For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.
  • The present invention is directed to a cutting tool for the cutting of components formed of an elastomeric material (e.g., rubber), to provide for subsequent materials testing of the component. While specific examples are provided herein of a cutting tool configured to cut elastomeric components included in a medical injection device (e.g., a syringe), it is recognized that the cutting tool could be used to cut other elastomeric components not associated with a medical injection device, and thus the specific examples provided below are not meant to limit the scope of the disclosure.
  • Referring to FIGS. 1 and 2, shown is a non-limiting embodiment of a medical injection device 10, such as a syringe for example, with which aspects or embodiments of the disclosure may be implemented. While the medical injection device is shown and described hereafter as a syringe 10, it is recognized that other medical injection devices may incorporate aspects of the disclosure, as described in detail here below.
  • As shown in FIGS. 1 and 2, the syringe 10 generally includes a syringe barrel 12 and a plunger assembly 14. The plunger assembly 14 is movable within the syringe barrel 12 along a longitudinal axis to an advanced position to facilitate administering of an injectable fluid (e.g., medication) to a patient, for example. The syringe barrel 12 is formed of a generally cylindrical outer wall 16 and an end member 18 that collectively define a chamber 20 for retaining fluid therein. The syringe barrel 12 includes an open proximal end 22 configured to receive the plunger assembly 14 therein and a distal end 24 at which end member 18 is positioned. The proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate handling and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 with respect to the plunger assembly 14 during medication administration. At the distal end 24, the end member 18 may include a shoulder 28 which narrows with respect to the cylindrical outer wall 16, as well as a hub portion 30 extending out distally from shoulder 28. The hub portion 30 is formed as a partially hollow member that defines a channel 32 therethrough in fluid communication with the chamber 20. In some embodiments, a needle 34 is attached to the hub portion 30 within channel 32, such as by being glued or otherwise secured to the hub portion 30. In other embodiments, it is recognized that - rather than needle 34 - syringe 10 could instead include a luer connection formed at the distal end 24 of syringe barrel 12 that enables the syringe 10 to be directly coupled to a luer connection of an associated medical device or component, to provide for the direct transfer of fluids therebetween.
  • The plunger assembly 14 of syringe 10 is formed of an elongate plunger rod 36 (more generally "plunger 36," as used hereafter) and a plunger head or stopper 38. The plunger 36 may include a main body 40 extending between a plunger proximal end 42 and a plunger distal end 44. In some embodiments, the main body 40 may include a plurality of elongate vanes or walls 46 extending axially along a length thereof between the plunger proximal end 42 and the plunger distal end 44. A thumb press 48 is positioned at the plunger proximal end 42 that may be engaged by a thumb (or other finger) of the user to apply a distally directed force to the plunger assembly 14 to move the plunger 36 with respect to the syringe barrel 12. In some embodiments, a flanged extension member 50 (e.g., disc-shaped flange) is positioned at the plunger distal end 44 that is configured to mate with the stopper 38. In other embodiments, the plunger distal end 44 may include a female receptacle formed therein that is configured to receive and connect to a protrusion (e.g., pin) extending out proximally from the stopper, with the protrusion and receptacle engaging via threading, for example.
  • The stopper 38 of plunger assembly 14 is positioned at the plunger distal end 44 so as to be movable along with the plunger 36 within the chamber 20 of syringe barrel 12. The stopper 38 may be made from a material that is different from the material of the plunger 36 and that is capable of forming a tight seal with the syringe barrel 12 as it is advanced therethrough. In some embodiments, the stopper 38 includes a receptacle (not shown) formed therein that is sized and configured to receive the flanged extension member 50 of plunger 36, with the flanged extension member 50 coupling with the receptacle via a press fit connection, for example, to secure the stopper 38 to the plunger 36, although it can be appreciated that the stopper 38 and plunger distal end 44 can be secured by other techniques known in the art.
  • As shown in FIGS. 1 and 2, and now also in FIG. 3, syringe 10 further includes a tip cap 60 that may be coupled to the hub portion 30 of syringe barrel 12. While shown in FIGS. 1 and 2 as a needle shield that is used to protect the needle 34, tip cap 60 could instead be configured as a cap that covers a luer connection. In embodiments where the tip cap 60 is configured as a needle shield, the tip cap 60 may be composed of a rigid outer casing 62 that provides structure to the tip cap 60 and a compliant inner casing 64 that surrounds the needle 34 (when needle shield 60 is coupled to syringe barrel 12). In various embodiments, the outer casing 62 may be made of a rigid material, while the inner casing 64 is made of a deformable or elastomeric material (e.g., rubber). In embodiments where the tip cap 60 is configured as a cap that covers a luer connection, the tip cap 60 may be composed of only a rigid material.
  • According to aspects of the disclosure, it may be desirable to perform testing on certain components of the syringe to verify that the components meet manufacturing standards. As one example, elastomeric components of the syringe 10 - such as the stopper 38 and/or tip cap 60 (with elastomeric inner casing 64) - may undergo materials testing such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples, to ensure that the components will function as required during use of the syringe 10. For performing such testing, it may be required to perform an initial cutting of the stopper 38 or tip cap 60 to provide a suitable specimen for testing, such as by cutting the stopper 38 or tip cap 60 in cross-section to specified dimensions (e.g., width, thickness, etc.).
  • Referring now to FIGS. 3-8, views of a cutting tool 70 for performing a cutting of a stopper 38, tip cap 60, or any other desired elastomeric component, are shown according to an embodiment of the disclosure. The cutting tool 70 generally includes a fixed base 72, an insert 74 (selected from a number of inserts) configured to retain an elastomeric component therein, and a cutting blade 76 for cutting the elastomeric component.
  • The fixed base 72 of cutting tool 70 is configured as an elongate structure having a first end 78 and a second end 80. A grip 82 is positioned at the first end 78 of the fixed base 72 that enables a user to grasp and secure the cutting tool 70 during use thereof. In some embodiments, the grip 82 may have a rounded top surface 84 that is ergonomically designed to enable grasping thereof by a user. An insert holder 86 is positioned at the second end 80 of the fixed base 72 that is configured to receive a removable insert 74, as explained in further detail below. As best shown in FIG. 6, the insert holder 86 includes a lower support platform 88 on which the insert 74 may be positioned, along with an engagement feature 90 extending upward from the lower support platform 88 and that mates with the insert 74 to secure the insert 74 to the fixed base 72.
  • The lower support platform 88 may present a planar top surface 92 on which the insert 74 rests when engaged with the fixed base 72. In some embodiments, a profile (i.e., outer perimeter) of the lower support platform 88 generally corresponds in shape to a shape of the insert 74, such that the lower support platform 88 supports an entirety of the insert 74.
  • According to aspects of the disclosure, the engagement feature 90 of insert holder 86 may be configured as a generally box-shaped receptacle ("box-shaped receptacle 90") therein shaped to accommodate a portion of the insert 74 therein. The receptacle 90 may have an open top end 92 that provides for sliding engagement of the insert 74 with the receptacle.
  • The fixed base 72 of cutting tool 70 also includes a guard feature 94 that is positioned between the grip 82 and the insert holder 86. The guard 94 extends upwardly from the grip 82 and the insert holder 86, so as to separate the grip 82 from the insert holder 86 and present a barrier there between. The guard 94 may be structured as a flange that extends up past the grip 82 of fixed base 72 and may have a shape that generally corresponds to the shape of the top surface of grip 82. Thus, in some embodiments, the guard 94 may have a rounded top edge or profile that generally matches a rounded top surface 84 of grip 82.
  • In some embodiments, a bottom surface 96 of the fixed base 72 may include a plurality of anti-skid pads 98 thereon that are dispersed about a perimeter of the fixed base 72. The anti-skid pads 98 may be composed of rubber or another suitable material that provides a high coefficient of friction between the fixed base 72 and a surface on which the cutting tool 70 is placed. The anti-skid pads 98 may thus help to prevent movement of the cutting tool 70 during use thereof.
  • The insert 74 of cutting tool 70 is provided as a separate component from the fixed base 72 that may be selectively added thereto and/or removed therefrom. In some embodiments, the insert 74 is formed of a metallic material that resists wear during operation of the cutting tool 70 (and contact between the cutting blade 76 and the insert 74). The insert 74 is engageable with the insert holder 86 and is configured to retain an elastomeric component therein, so as to enable cutting of the component. The insert 74 may be characterized as generally including a main body 102 and a flange 104 - with the flange 104 spaced apart longitudinally from the main body 102 (toward the first end 78) and j oined thereto via a connecting portion 106.
  • The flange 104 of insert 74 is configured to mate with the engagement feature 90 to secure the insert 74 to the fixed base 72. Thus, where the engagement feature 90 is provided as a box-shaped receptacle 90 as described above, the flange 104 may have a rectangular shape configured to be received in the box-shaped receptacle 90 - with the connecting portion 106 of the insert 74 being accommodated by an opening/channel 108 formed in a sidewall 110 of the receptacle. The flange 104 of insert 74 may be slid down into the box-shaped receptacle 90 (through the open top end 92) to secure the insert 74 to the fixed base 72.
  • The main body 102 of insert 74 may comprise a cube-shaped body having a height, H, that matches that of the flange 104, the connecting portion 106, and the box-shaped receptacle 90. As described above, the main body 102 may have a profile/perimeter generally matching that of lower support platform 88, such that an entirety of the main body 102 (and overall insert 74) rests on the platform 88. The main body 102 includes a slot 112 formed therein that extends from a top surface 114 and down through a portion of the height, H, of the main body 102. In some embodiments, the slot 112 may extend down through the main body 102 a majority of the height, H, thereof. The slot 112 is sized and configured to receive the cutting blade 76 therein, with a width of the slot 112 being such that the sides of the blade 76 do not make contact with the main body 102 when the blade is advanced into the slot 112, but with a width of the slot 112 also preventing excess movement/deflection of the blade 76 in the longitudinal direction. The slot 112 is oriented in main body 102 in a direction orthogonal to the longitudinal direction of the fixed base 72 (extending between the first and second ends 78, 80). The slot 112 may extend a full breadth of the main body 102, such that the slot 112 is open on opposed sides of the main body 102.
  • The main body 102 also includes a component receptacle 116 formed therein that is configured to receive and retain the elastomeric component. The component receptacle 116 is formed in the top surface 114 of main body 102 to enable placement of the component therein from a top side of the cutting tool 70. The component receptacle 116 is generally centered on the main body 102 and positioned such that the component receptacle 116 is intersected by the slot 112. With the slot 112 intersecting the component receptacle 116 in this manner, the elastomeric component is retained at a location where the cutting blade 76 acts to cut the elastomeric component in cross-section when advanced into the slot 112.
  • According to aspects of the disclosure, the cutting tool 70 enables the cutting of various types of elastomeric components therein - with inserts 74 of multiple configurations being engageable with the fixed base 72, where each insert 74 may be configured to retain a specific component therein and provide for cutting of the component according to desired specifications (i.e., at a desired width and along a desired cross-sectional cutting line orientation). By providing interchangeable inserts 74 that may be added/removed to the fixed base 72, a cutting tool 70 may be provided that is useable for cutting a variety of different elastomeric components.
  • Referring to FIGS. 7 and 8, non-limiting examples of different insert configurations are illustrated that may be interchangeably added/removed to the fixed base 72 to enable cutting of different elastomeric components. It is understood that inserts 74 of many different configurations may be used in the cutting tool 70 - beyond the inserts shown in FIGS. 7 and 8 - including inserts for cutting other elastomeric components of a syringe and elastomeric components used in other devices.
  • FIG. 7 illustrates an insert 74a configured to receive and retain an elastomeric syringe plunger stopper 38 to provide for cutting thereof. The insert 74a includes a flange 104, main body 102, and connecting portion 106 as previously described, with a slot 112 and component receptacle 116 formed in the main body 102. The component receptacle 116 may have a generally rectangular or square profile and may have a rounded (i.e., semi-cylindrical) bottom surface that is configured to receive the stopper 38 therein. The dimensions of the component receptacle 116 may vary depending on the size of the stopper 38 (e.g., for a 1 mL syringe, 5 mL syringe or 10 mL syringe, as non-limiting examples) and/or the orientation in which the stopper 38 is to be positioned therein. That is, the component receptacle 116 may be configured to receive the stopper 38 in a first orientation to enable a cross-sectional cutting thereof in a first direction/dimension or may be configured to receive the stopper 38 in a second orientation to enable a cross-sectional cutting thereof in a second direction/dimension.
  • FIG. 8 illustrates an insert 74b configured to receive and retain a syringe tip cap 60 (including an elastomeric inner casing 64) to provide for cutting thereof. The insert 74b includes a flange 104, main body 102, and connecting portion 106 as previously described, with a slot 112 and component receptacle 116 formed in the main body 102. The component receptacle 116 may have an elongated profile and may have a rounded (i.e., semi-cylindrical) bottom surface that is configured to receive the syringe tip cap 60 therein. In some embodiments, the elongated component receptacle 116 may have a first portion having a first diameter and a second portion having a second diameter that is less than the first diameter. The dimensions of the component receptacle 116 may vary depending on the size of the syringe (e.g., for a 1 mL syringe, 5 mL syringe or 10 mL syringe, as non-limiting examples) with which the syringe tip cap 60 is used and/or the orientation in which the syringe tip cap 60 is to be positioned therein. That is, the component receptacle 116 may be configured to receive the syringe tip cap 60 in a first orientation to enable a cross-sectional cutting thereof in a first direction/dimension or may be configured to receive the syringe tip cap 60 in a second orientation to enable a cross-sectional cutting thereof in a second direction/dimension.
  • Referring again now to FIGS. 3-4 the cutting blade 76 of cutting tool 70 is shown therein as being configured to be inserted within the slot 112 of insert 74 for cutting of the elastomeric component retained therein. According to an embodiment of the disclosure, the cutting blade 76 may be configured as a slitter blade with a sharpened front edge 118, although it is recognized that the blade 76 could instead be a circular blade or blade of another suitable configuration. The blade 76 may be formed of a metallic, ceramic, or composite material that is suitable for cutting rubber or another elastomeric material, with the blade 76 being formed of stainless steel, high carbon, solid carbide, ceramic, an aluminum alloy, or beryllium copper, as non-limiting examples.
  • In certain configurations, the cutting tool 70 further includes a blade actuator 120 configured to advance the cutting blade 76 into the slot 112. The actuator 120 may comprise a manually drive actuator, such as a handle, that is mechanically connected to the cutting blade 76 and that may be operated by a user to advance the cutting blade 76 into the slot 112 of insert 74 to perform a cutting of the elastomeric component. In other embodiments, the actuator 120 may drive the cutting blade 76 in an automated or assisted fashion, with the actuator 120 being provided a hydraulic or pneumatic actuator or as a servo-motor type actuator.
  • According to aspects of the disclosure, the cutting tool 70 as described above may be employed to perform a cutting of an elastomeric component. In performing a cutting operation, an insert 74 of a desired configuration is first attached to the fixed base 72 (i.e., to the insert holder 86). As described above, to engage the insert 74 with the fixed base 72, the flange 104 on insert 74 may be slid down into an engagement feature 90 (e.g., a box-shaped receptacle 90) of the insert holder 86, to secure the insert 74 to the fixed base 72. As described above, in attaching an insert 74 to the fixed base 72, a specifically configured insert 74 may be selected that is designed to enable cutting of a desired elastomeric component according to desired specifications (i.e., at a desired width/thickness and along a desired cross-sectional cutting line orientation). In some embodiments, an insert 74a having a first configuration may be attached to the fixed base 72 - with the insert 74a having a component receptacle 116 formed in the main body 102 that is configured to receive and retain an elastomeric syringe plunger stopper 38 therein. In other embodiments, an insert 74b having a second configuration may be attached to the fixed base 72 - with the insert 74b having a component receptacle 116 formed in the main body 102 that is configured to receive and retain a syringe tip cap 60 (including an elastomeric inner casing 64) therein.
  • Upon attaching of the insert 74 to the fixed base 72, an elastomeric component is then placed into the component receptacle 116 of the insert 74. With the elastomeric component properly placed into the component receptacle 116, the cutting blade 76 of cutting tool 70 may then be actuated (e.g., manually or via a drive/motor), so as to advance the cutting blade 76 into/through the slot 112 of insert 74, thereby cutting the elastomeric component in cross-section according to a desired profile. Upon cutting of the elastomeric component in cross-section, the elastomeric component may be removed from the cutting tool 70 and material testing may then be performed on the elastomeric component, such as tensile strength testing and/or dynamic mechanical analysis, as non-limiting examples.
  • Beneficially, embodiments of the invention thus provide a cutting tool configured to cut elastomeric components (e.g., syringes stoppers or syringe tip caps, as non-limiting examples) according to a desired profile and that provide for subsequent materials testing thereof. The cutting tool is adaptable/configurable to cut multiple different components and to cut a component to a specific width and in different sectional plans, so as to provide flexibility in testing components having different sizes and shapes. The cutting tool provides precise control during cutting and includes ergonomic and safety features thereon, to aid in use of the cutting tool.
  • Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims (15)

  1. A cutting tool for cutting an elastomeric component, the cutting tool comprising:
    a fixed base having a first end and a second end, the fixed base comprising:
    a grip positioned at the first end;
    an insert holder positioned at the second end, the insert holder comprising a lower support platform and an engagement feature extending upward from the lower support platform; and
    a guard positioned between the grip and the insert holder, the guard extending upwardly from the grip and the insert holder;
    an insert engageable with the insert holder and configured to retain an elastomeric component therein, the insert comprising:
    a flange configured to mate with the engagement feature to secure the insert to the fixed base; and
    a main body joined with the flange and spaced apart therefrom toward the second end, the main body comprising:
    a slot formed orthogonal to the fixed base, the slot formed in a top surface of the main body and extending downwardly through a portion of the main body; and
    a component receptacle configured to receive and retain the elastomeric component therein, wherein the component receptacle is intersected by the slot; and
    a cutting blade insertable within the slot and configured to cut the elastomeric component retained within the component receptacle.
  2. The cutting tool of claim 1, wherein the slot intersects with the component receptacle such that the cutting blade is positioned to cut the elastomeric component in cross-section.
  3. The cutting tool of claim 2, wherein the insert comprises a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  4. The cutting tool of claim 3, wherein the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a first orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a first direction.
  5. The cutting tool of claim 3, wherein the first component receptacle is configured to receive and retain the elastomeric syringe plunger stopper in a second orientation, such that the elastomeric syringe plunger stopper is cut in cross-section in a second direction.
  6. The cutting tool of claim 2, wherein the insert comprises a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein, the syringe tip cap including an elastomeric inner cap portion.
  7. The cutting tool of claim 6, wherein the second component receptacle is configured to receive and retain the syringe tip cap in a first orientation, such that the syringe tip cap is cut in cross-section in a first direction.
  8. The cutting tool of claim 6, wherein the second component receptacle is configured to receive and retain the syringe tip cap in a second orientation, such that the syringe tip cap is cut in cross-section in a second direction.
  9. The cutting tool of any of claims 1-8, wherein an entirety of the insert is positioned on a top surface of the lower support platform.
  10. The cutting tool of any of claims 1-9, wherein the engagement feature comprises a box-shaped receptacle therein having an open top end, and wherein the flange of the insert slides down into the box-shaped receptacle to secure the insert to the fixed base.
  11. The cutting tool of any of claims 1-10, wherein the fixed base comprises a flat bottom surface including a plurality of anti-skid pads thereon.
  12. The cutting tool of any of claims 1-11, further comprising a blade actuator configured to advance the cutting blade into the slot.
  13. A method for cutting an elastomeric component using the cutting tool of claim 1, the method comprising:
    attaching the insert to the insert holder by engaging the flange with the engagement feature;
    placing the elastomeric component into the component receptacle; and
    actuating the cutting blade so as to advance the cutting blade into the slot, thereby cutting the elastomeric component.
  14. The method of claim 14, wherein attaching the insert comprises attaching a first insert having a first component receptacle formed in the main body, the first component receptacle configured to receive and retain an elastomeric syringe plunger stopper therein.
  15. The method of claim 14, wherein attaching the insert comprises attaching a second insert having a second component receptacle formed in the main body, the second component receptacle configured to receive and retain a syringe tip cap therein.
EP24305286.7A 2024-02-21 2024-02-21 Tooling for cutting of elastomeric components Pending EP4606540A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP24305286.7A EP4606540A1 (en) 2024-02-21 2024-02-21 Tooling for cutting of elastomeric components
PCT/US2025/016293 WO2025178865A1 (en) 2024-02-21 2025-02-18 Tooling for cutting of elastomeric components

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP24305286.7A EP4606540A1 (en) 2024-02-21 2024-02-21 Tooling for cutting of elastomeric components

Publications (1)

Publication Number Publication Date
EP4606540A1 true EP4606540A1 (en) 2025-08-27

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EP (1) EP4606540A1 (en)
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5890291A (en) * 1997-05-05 1999-04-06 Crum Manufacturing, Inc. Enclosed blade fixture for cutting hoses
US7954408B1 (en) * 2007-02-23 2011-06-07 Keely Sr Sidney E Bagel and english muffin slicing apparatus and associated method

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5890291A (en) * 1997-05-05 1999-04-06 Crum Manufacturing, Inc. Enclosed blade fixture for cutting hoses
US7954408B1 (en) * 2007-02-23 2011-06-07 Keely Sr Sidney E Bagel and english muffin slicing apparatus and associated method

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