Low friction oil-free syringe plunger feed tube and method of using same to feed a plunger into a syringe

Abstract

A supply tube for placing a syringe gasket into a medical barrel, as well as related systems and methods for using such a supply tube, is disclosed. An optional tube according to the present disclosure is configured to hold and supply a syringe gasket to a medical barrel. The tube includes an elongated hollow tubular body including an internal lumen. The lumen has an inner wall consisting of a contact surface configured to contact a portion of the circumferential surface of the gasket and a non-contact surface occupying the remainder of the inner wall.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 268,872, entitled “REDUCED FRICTION OIL-FREE SYRINGE PLUNGER FEEDING TUBS AND METHODS OF USING THE SAME FOR FEEDING PLUNGERS INTO SYRINGES,” filed March 4, 2022, the contents of which are incorporated by reference in their entirety herein.

[0002] 1. Technical Field The disclosed concepts relate to an apparatus and components thereof for feeding a plunger into a syringe barrel. More specifically, the disclosed concepts relate to a plunger feeding tube configuration that provides reduced frictional resistance to facilitate feeding of the plunger into the syringe without a mobile lubricant. [Background technology]

[0003] 2. 2. Description of Related Art There are three conventional methods for assembling a conventional syringe plunger, i.e., a gasket, onto a pre-filled syringe. The first is the use of a vent tube, where the gasket is pushed through a tube placed within the syringe, exiting the bottom of the tube and entering its final position within the syringe barrel. The second is the use of a vacuum, created within the syringe, where the gasket is introduced into its opening. The pressure differential forces the gasket down into the barrel into its final position. The third method, known as vacuum assist, further involves a mechanical element that creates a vacuum and assists in placing the gasket into its final position.

[0004] Regardless of which method is used, feeding the gasket into the syringe involves the use of a tube through which the gasket is inserted and fed into the proximal open end of a medical barrel, e.g., a syringe barrel. Such a "feed tube" is typically made from metal and must be configured to hold the gasket in place when positioned over the open end of the syringe barrel while at the same time allowing the gasket to advance with relatively low frictional resistance in and out of the feed tube. High friction can damage the gasket and slow down the improper or in-line feeding process.

[0005] For purposes of illustrating background and the state of the art, FIG. 6 shows a pre-filled syringe 1010 including a medical barrel 1012 that is filled with a liquid medication 1014. The medical barrel 1012 includes a proximal open end 1018 into which a supply tube 1020 is inserted to deposit a gasket 1016 within the medical barrel 1012. As shown, the gasket 1016 serves to seal the liquid medication 1014 within the medical barrel 1012. When administering the medication 1014 to a patient, the gasket 1016 is advanced distally, for example, with a plunger rod coupled to the gasket 1016 and protruding from the proximal open end 1018 to dispense the medication 1014.

[0006] As shown in FIG. 7, the supply tube 1020 has a circular interior and exterior shape. The supply tube 1020 includes a hollow tubular body 1022 having an interior wall 1026 that defines a lumen 1024. The lumen 1024 is configured to have a gasket placed therein prior to feeding the gasket into the syringe barrel. The interior wall 1026 includes a contact surface 1028 that is configured to contact an exterior wall of a gasket disposed within the lumen 1024. Notably, the interior wall 1026 and the contact surface 1028 of this prior art supply tube 1020 are one and the same. In other words, the interior wall 1026 and the contact surface 1028 are coextensive. Thus, the exterior wall of the gasket is disposed within the lumen 1024, at least along the widest section of its one or more cylindrical portions, and contacts the entirety of the interior wall 1026 as it advances through the lumen 1024. Applicants have determined that such full surface contact provided by conventional feeding tubes is at least partially responsible for the increased frictional resistance as the gasket advances through lumen 1024.

[0007] To address the issue of friction, a liquid or gel-like mobile lubricant such as free silicone oil (e.g., polydimethylsiloxane or PDMS) is typically used to provide lubrication between the gasket and the inner surface of the supply tube to provide a desirably low frictional resistance. For example, the inner surface of the supply tube can be spray-coated with silicone oil. Silicone oil is in fact a standard mobile lubricant used in the industry. However, silicone oil in the supply tube can migrate onto the gasket surface during supply and can be found inside the filled syringe as oil droplets. In some applications, this can be problematic. One reason is that the mobile lubricant can mix and interact with the pharmaceutical agent in the syringe, degrading the drug or otherwise affecting its efficacy and / or safety. Degradation is particularly problematic for protein and polypeptide compositions. Some biopharmaceuticals are susceptible to one or more adverse effects from interactions with particles generated from the mobile lubricant. These adverse effects can include protein denaturation, protein aggregation, protein degradation, eliciting undesirable immune responses in patients administered the drug, and degrading the efficacy of the drug. Furthermore, apart from their effect on the pharmaceutical product, the lubricant itself may present a health risk when injected into a patient. Furthermore, pharmaceutical guidelines limit the presence of particles (e.g. oil particles) that are permitted in drugs. Therefore, in some applications it is desirable to have a means to supply gaskets in pre-filled syringes without mobile lubricants.

[0008] Applicant is currently developing a gasket design and method for making the gasket, which is currently being developed in-house and is not yet publicly available and is not part of the state of the art. Applicant has found that this gasket has demonstrated improved performance when used in a syringe. However, Applicant's own experience testing this gasket design has revealed that the gasket is more prone to radial deformation when fed into a syringe through a standard feeding tube via the method described above. Applicant has therefore determined that there is a need for a method and associated equipment for this unique gasket configuration that reliably promotes a smooth feeding process without distorting the shape of the gasket and preferably without or substantially without any oil for lubrication between the gasket and the feeding tube. Summary of the Invention

[0009] Thus, in one optional aspect, a tube for holding and delivering a syringe gasket to a medical barrel is provided, the tube including an elongated hollow tubular body including an interior lumen, the lumen having an inner wall including a contact surface configured to contact an outer wall of the gasket, the contact surface having a surface area less than the surface area of ​​the inner wall.

[0010] In another aspect, the tube comprises an elongate hollow tubular body including an inner lumen having an inner wall including a contact surface configured to contact an outer wall of the gasket, the contact surface including two or more guide rails extending axially along the lumen.

[0011] Optionally, in any embodiment, the contact surface includes a non-stick coating deposited thereon.

[0012] In one optional embodiment, the disclosed solution reduces risk to the patient since there is no longer any introduction of silicone oil or other mobile lubricant particles into the drug preparation. Another advantage is that the delivery of the gasket is no longer dependent on uniform distribution of lubricant along the glide surface area.

[0013] Optionally, the disclosed concepts are directed to a system for delivering a syringe gasket to a medical barrel. In one optional aspect, the system includes a gasket configured for insertion into the medical barrel. The gasket has a body made of a resilient material and has a distal nosecone configured to face a product stored within the medical barrel when the gasket is inserted into the medical barrel, and a circumferential surface portion extending proximally from the nosecone. At least a portion of the circumferential surface portion is configured to contact an interior sidewall of the medical barrel in compressive engagement. The system further includes a tube for holding the gasket and then delivering the gasket into the medical barrel. The tube includes an elongated hollow tubular body having an interior lumen. The lumen has an interior wall comprised of a contact surface configured to contact a portion of the circumferential surface portion of the gasket and a non-contact surface occupying a remainder of the interior wall. The gasket is positioned within the tube such that along a selected plane perpendicular to the central axis of the tube, a first portion of the circumferential surface portion of the gasket contacts and is in compressive engagement with the contact surface, while a second portion of the circumferential surface portion of the gasket is either not in contact with the non-contact portion or in contact with the non-contact portion but with less compression relative to the non-contact portion than exists between the first portion of the circumferential surface portion of the gasket and the contact surface.

[0014] The disclosed concepts are also directed to a method of supplying a syringe gasket to a medical barrel. Optionally, the method employs the use of the components of the system described in the paragraph immediately above. In an optional aspect, the method includes placing a gasket in a tube such that along a selected plane perpendicular to a central axis of the tube, a first portion of a circumferential surface portion of the gasket contacts and compressively engages with a contact surface, while a second portion of the circumferential surface portion of the gasket does not contact a non-contact portion or contacts the non-contact portion but with less compression relative to the non-contact portion than exists between the first portion of the circumferential surface portion of the gasket and the contact surface. The tube is aligned with a proximal open end of the medical barrel. The gasket is slid through the tube and then transferred from the tube into the medical barrel.

[0015] Optionally, in any embodiment, the contact surface includes two or more guide rails extending axially along the lumen. Optionally, the guide rails are rounded outwardly along a cross-sectional plane perpendicular to the central axis of the tube. As an alternative option, the guide rails are rounded inwardly along the cross-sectional plane. Optionally, the tube includes between 2 and 8 guide rails. Optionally, there is an even number of guide rails, each guide rail facing another guide rail located 180 degrees from it around the lumen.

[0016] Optionally, in any embodiment, the contact surface optionally has a surface area that is less than the surface area of ​​the inner wall, the surface area being less than 75%, optionally less than 65%, optionally less than 50%, optionally less than 40%, optionally less than 30%, optionally between 15% and 50%, or optionally between 25% and 50% of the surface area of ​​the inner wall.

[0017] Optionally, in any embodiment, the contact surface comprises a surface coating having a low surface energy. Optionally, the surface coating comprises a sol-gel coating. Optionally, the surface coating comprises an inorganic-organic hydride polymer, such as an ORMOCER® coating. Optionally, the surface coating comprises a fluorinated polymer, optionally a member selected from the group consisting of fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), and perfluoroalkoxy (PFA).

[0018] Optionally, in any embodiment, the tube is constructed from or includes a polyoxymethylene homopolymer, polytetrafluoroethylene, or a molten mixture of the two.

[0019] Optionally, in any embodiment, the tube is constructed from or comprises a polyoxymethylene homopolymer having polytetrafluoroethylene fibers uniformly blended in the polyoxymethylene homopolymer.

[0020] Optionally, in any embodiment, a circumferential surface portion of the gasket has one or more ribs projecting radially outwardly and configured to engage and provide a seal between the gasket and a medical barrel in which the gasket is disposed. At least one of the one or more ribs includes a channel or channels extending along at least a portion of a circumference of at least one of the one or more ribs. Optionally, the one or more ribs include a distal rib adjacent the nosecone, and the channel or channels are disposed on the distal rib. Optionally, the channel or channels are laser cut. Optionally, the channel or channels are non-contiguous.

[0021] Optionally, in any embodiment of the gasket, the film is present on at least a portion of a circumferential outer portion of the gasket.

[0022] Optionally, in any embodiment, the gasket includes a body having an internal cavity, the cavity being defined by an inner surface portion of the gasket and open at one end. A film is present on at least a portion of a circumferential surface portion of the gasket. The plurality of non-continuous channels in or through the film are generally parallel to the other non-continuous channels. Each non-continuous channel of the plurality of non-continuous channels extends around a circumferential outer surface of the gasket and has a non-channel portion that interrupts the non-continuous channel. The non-channel portion of each non-continuous channel is positioned along the circumferential outer surface portion of the gasket such that the non-channel portion of each non-continuous channel is not aligned with the non-channel portion of an immediately adjacent non-continuous channel. Optionally, the plurality of non-continuous channels are provided on a rib of the gasket, preferably on a distal rib adjacent the nosecone.

[0023] Optionally, in any embodiment of the systems or methods disclosed herein, there is no mobile lubricant in the tube. [Brief description of the drawings]

[0024] The background of the invention and the invention itself will now be described in conjunction with the following drawings, in which like reference numbers designate like elements and in which:

[0025] [Figure 1] FIG. 1 is a cross-sectional view of a syringe including a syringe barrel assembled with a gasket attached to a plunger rod.

[0026] [Diagram 2] FIG. 2 is a partial detailed view of the syringe of FIG.

[0027] [Figure 3A] FIG. 3A is a schematic cross-sectional view taken along section line 3A-3A of FIG.

[0028] [Figure 3B] FIG. 3B is a detailed view of a portion of the structure of FIG. 3A, showing one embodiment of each of the non-continuous channels extending around the circumferential outer surface of the gasket core and generally parallel to the first non-continuous channel and a lip on each side of the channel.

[0029] [Figure 3C] FIG. 3C is a top view of a gasket showing the approximate geometric distribution of the non-continuous channels extending around the circumferential outer surface of the gasket core.

[0030] [Figure 3D] FIG. 3D is a top view of a gasket showing the approximate geometric distribution of three non-contiguous channels extending around the circumferential outer surface of the gasket core, which are axially spaced from one another, each of which includes a respective non-channel portion.

[0031] [Figure 4A]FIG. 4A is a schematic diagram of an assembly of a gasket and a mandrel inserted into the interior cavity of the gasket with a laser beam applied at an angle to an outer portion of a film on a circumferential outer surface portion of the gasket while the mandrel and gasket are rotated along the longitudinal axis of the mandrel to generate non-continuous channels in the film on the circumferential outer portion of the gasket.

[0032] [Figure 4B] FIG. 4B is a schematic cross-sectional view of one embodiment of a gasket taken along section line 4B-4B of FIG. 4A, showing a mandrel secured within the interior cavity of the gasket and non-continuous channels in the outer surface of the film on a circumferential outer surface portion of the gasket.

[0033] [Figure 5A] FIG. 5A is a gasket having a film with a first non-continuous channel within the film.

[0034] [Figure 5B] FIG. 5B is a detailed view of a portion of the gasket of FIG. 5A showing an embodiment of a first non-continuous channel in a surface of the film with a lip on each side of the first non-continuous channel and various dimensions of the first non-continuous channel shown.

[0035] [Figure 6] FIG. 6 is a schematic diagram, shown for background purposes, of a conventional system for supplying gaskets to pre-filled syringes.

[0036] [Figure 7] FIG. 7 is a cross-sectional view of a prior art supply tube.

[0037] [Figure 8] FIG. 8 is a cross-sectional view of a supply tube according to a first optional embodiment of the disclosed concepts.

[0038] [Figure 9]FIG. 9 is a cross-sectional view of a supply tube according to a second optional embodiment of the disclosed concepts.

[0039] [Figure 10] FIG. 10 is a cross-sectional view of a supply tube according to a third optional embodiment of the disclosed concepts.

[0040] [Figure 11] FIG. 11 is a cross-sectional view of a supply tube according to a fourth optional embodiment of the disclosed concepts. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The disclosed concepts will now be more fully described with reference to the accompanying drawings showing several embodiments. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are examples of the present invention having the full scope indicated by the language of the claims. Like numbers refer to like elements throughout. Unless otherwise specified, the features characterizing the embodiments and aspects described in the following disclosure can be combined with each other, and the resulting combinations are also embodiments of the disclosed concepts.

[0042] definition As used in this disclosure, the term "syringe" refers to a device that includes a medical barrel and a gasket disposed within the medical barrel to dispense liquid contents into the medical barrel or to draw liquid into the medical barrel. A syringe is broadly defined to include cartridges, injection "pens," and other types of barrels or reservoirs that are adapted to be assembled with one or more other components to provide a functional syringe. A "syringe" is also broadly defined to include related articles such as automated syringes that provide a mechanism for dispensing contents. Optionally, a syringe may include a pre-filled syringe. As used herein, a syringe may also have applications in diagnostics, e.g., sampling devices that include a medical barrel pre-filled with a diagnostic agent (e.g., contrast dye) or the like. The present invention is not necessarily limited to a particular volume of syringe, but for example, syringes with lumens having void volumes of 0.5-50 mL, optionally 1-10 mL, optionally 0.5-5 mL, and optionally 1-3 mL are envisioned.

[0043] As used herein, the term "gasket" in the context of the present disclosure is a molded piece or ring made of an elastomeric material that can be used to mechanically seal the space between two opposing inner surfaces of a syringe barrel. The gasket is also called a plunger. The gasket is preferably cylindrical in shape with a short axis. The gasket has a circumferential surface portion that is held in substantially air-tight and liquid-tight contact with the inner peripheral surface of the syringe barrel. The gasket of the present disclosure may be a gasket that includes a body made of an elastic material and a film that is present on at least the circumferential surface of the body, the gasket having a circumferential surface portion and an internal cavity (IC) at its center, the cavity being defined by the inner surface of the gasket and one end of the cavity being open.

[0044] The "elastic material" may be a rubber or elastomer. Specifically, preferred types of rubber include butyl rubber, chlorinated butyl rubber, and brominated butyl rubber. Other types of elastic materials may include thermoset rubbers and dynamically crosslinkable thermoplastic elastomers that have crosslinking sites that make them heat resistant. These polymeric components of such elastomers include ethylene-propylene-diene rubber and butadiene rubber. As used herein, the term "film" refers to a material present on at least a circumferential outer surface portion of the body of the gasket. Preferably, the film coats or is present on substantially all of the outer surface of the gasket. The film may have an optional thickness of less than about 100 micrometers (μm or microns), optionally about 10-30 microns, about 15-35 microns, or about 20-50 microns. Most preferably, the thickness of the film is about 20 microns. A variety of different materials may be used for the film, such as, for example, fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), ethylene perfluoroethylene propylene (EFEP), ethylene chlorotrifluoroethylene (ECTFE), polychlorotrifluoroethene (PCTFE), perfluoroalkoxy (PFA), among other coatings. Preferably, the film is an ultra-high molecular weight polyethylene film (UHMWPE) or a fluoropolymer film. Fluoropolymer films such as polytetrafluoroethylene (PTFE) are preferred due to their excellent sliding properties and chemical stability. The type of film provided on the surface of the gasket body is not particularly limited, as long as the film can prevent the migration of materials from the crosslinked rubber (body) and has a sliding property, i.e., a smaller coefficient of friction, compared to the gasket body.

[0045] Optionally, the film may include a CPT fluoropolymer. CPT is a modified perfluoroalkoxy (PFA) that generally involves the addition of PCTFE side chains to a PFA backbone during polymerization.

[0046] The term "channel" as used herein refers to a cut, preferably a laser cut, in the film on the surface of the gasket. The term channel may be used interchangeably with the term "cut". In this disclosure, the term "cut" may also refer to a process using one or more laser beams to create a cut or separation in the film present on at least the circumferential outer surface portion of the gasket. In some embodiments, the channel is a cut in the surface portion of the film. In a more preferred embodiment, the channel extends through the film into the outer surface of the gasket. One or more such channels may be created, each surrounding a portion of the gasket. Each channel has a non-channel portion where no channel / cut is formed. For example, the channel may surround 350 degrees of the gasket and the non-channel portion may surround the remaining 10 degrees of the 360 ​​degree circle on the gasket. When two or more channels are present, they are preferably axially spaced from each other. The non-channel portions of the two or more channels are not aligned on the gasket. For example, a non-channel portion may be located on one side of the gasket and a second non-channel portion may be located on the other side. Each channel has two lips. The term "lip" refers to the structure created by the build-up of film material along both sides of the channel created by laser beam cutting. Each lip is a raised microprojection positioned to intimately contact the inside surface of the barrel. Thus, each channel has two lips that include two sealing microprojections or peaks. In this disclosure, the terms "lip," "peak," and "microprojection" are interchangeable.

[0047] The laser cuts and the resulting channels are characterized by various dimensions including laser cut depth, radial depth, peak width, axial width, and peak height. The "laser cut depth" is measured from the surface of the uncut gasket film to the lowest point in the trough of the channel. The laser cut depth of the channel or channels is independently selected from the ranges of 30-60 microns, 40-50 microns, 50-60 microns, 40-45 microns, 45-50 microns, 50-55 microns, and 55-60 microns. The "radial depth" is measured from the uncut outer surface of the gasket to the lowest trough in the channel. The radial depth of the channel or channels may be independently selected from the ranges of 0-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns. The "peak width" is the distance between the two peaks of the two lips on either side of the channel. The peak width is measured from the top of the peak. The peak width may be one of the ranges of 200 to 1,000 microns, 275 to 550 microns, 300 to 400 microns, and 450 to 500 microns.

[0048] The circumferentially non-continuous channels of the present disclosure have axially opposed "first and second sidewalls" and a "floor". The floor of the channel can be either the film surface or, more preferably, the gasket surface, depending on the thickness of the film and the depth of the cut. The "axial width" is measured from the first sidewall to the second sidewall of the channel across the width of the channel floor. In other words, the "axial width" is measured across its width from one end of the channel to the other end of the channel at the baseline level, i.e., at the non-laser cut outer surface level of the film or gasket. The channel or channels independently have an axial width between sidewalls in one of the ranges of 1-100 microns, 5-50 microns, 10-30 microns, and 15-25 microns.

[0049] "Peak height" is measured from the surface of the uncut gasket film to the highest peak of the lip created by the laser beam along the central axis of the peak, i.e., perpendicular to the surface of the film. The peak height of one or more of the lips of the channels is independently selected from one of the following ranges: 10-100 microns, 15-60 microns, 20-50 microns, and 30-40 microns.

[0050] Supply pipe according to the disclosed concept As noted in the Background section above, Applicant's internally developed novel syringe gasket, while an improvement over the prior art, is more prone to radial deformation than conventional gaskets when fed into a syringe through a standard feed tube (e.g., the prior art feed tube described in the Background section and shown in FIG. 7). In response to this technical challenge, and as described in this disclosure, Applicant has determined that a new and alternative design for the feed tube is needed to overcome the aforementioned problems. It is a further object of the disclosed concept that minimal or no mobile lubricant (e.g., silicone oil) is required to feed the gasket through the feed tube into the syringe barrel.

[0051] 8-11, there are shown optional embodiments of supply tubes 120, 220, 320, 420 in accordance with the disclosed concepts. Each of these figures is a cross-section along a plane perpendicular to the central axis of a given supply tube 120, 220, 320, 420, showing the interior geometry of the supply tube 120, 220, 320, 420. Each supply tube 120, 220, 320, 420 includes a hollow tubular body 122, 222, 322, 422 having an interior wall 126, 226, 326, 426 that defines a lumen 124, 224, 324, 424. The lumen 124, 224, 324, 424 is configured to have a syringe plunger, i.e., a gasket, placed therein prior to feeding the gasket into the syringe barrel. The inner wall 126, 226, 326, 426 includes a contact surface 128, 228, 328, 428 configured to contact, and optionally provide a compressive engagement with, an outer wall of a gasket disposed within the lumen 124, 224, 324, 424.

[0052] Optionally, in any embodiment, the supply tube 120, 220, 320, 420 is constructed from or includes a material that can be machined or molded for precise measurements and tolerances. The material can be selected from a wide range of materials. Such materials can include, for example, metals or plastics that provide a low friction contact surface 128, 228, 328, 428. For example, if a plastic material is used, the plastic can be optionally selected from the group consisting of polystyrene, polycarbonate, polypropylene, polyethylene, polytetrafluoroethylene, ethylenetetrafluoroethylene, and any combination of the foregoing.

[0053] In a preferred embodiment, the supply tubes 120, 220, 320, 420 are constructed from or include polyoxymethylene homopolymer (also known as acetal homopolymer), or include polyoxymethylene copolymers, etc. The polyoxymethylene homopolymer may be formulated as an unmodified homopolymer, or may be formulated in a blend with polytetrafluoroethylene (PTFE). The mixture may be formulated by melting both the polyoxymethylene homopolymer and the PTFE and blending the two polymers. Alternatively, the polyoxymethylene homopolymer may be melted and PTFE fibers may be blended into the homopolymer. This material may be used in moving parts providing low friction and long wear life.

[0054] Unlike the inner wall 1026 and contact surface 1028 of the prior art supply tube 1020, the inner wall 126, 226, 326, 426 and contact surface 128, 228, 328, 428 of the supply tube 120, 220, 320, 420 according to the disclosed concept are not one and the same, nor are they coextensive. Rather, the contact surface 128, 228, 328, 428 has a surface area that is less than the surface area of ​​the inner wall 126, 226, 326, 426. Thus, the inner wall 126, 226, 326, 426 consists only of the contact surface 128, 228, 328, 428 and the non-contact surface 130, 230, 330, 430 (which occupies the remaining portion of the inner wall 126, 226, 326, 426). Mathematically, this can be expressed as follows: IW =A CS +A NC (and its collinear A IW -A CS =A NC and A IW -A NC =A CS ), wherein A IW = area of ​​inner wall, A CS = area of ​​contact surface, and A NC = area of ​​non-contact surface.

[0055] The non-contact surface 130, 230, 330, 430, unlike the contact surface 128, 228, 328, 428, is configured to not contact, or at least provide less contact force (i.e., reduced compressive engagement) against, the outer wall of a gasket disposed within the lumen 124, 224, 324, 424. With the contact surface 128, 228, 328, 428 having a smaller surface area than the total inner wall 126, 226, 326, 426, the supply tube 120, 220, 320, 420 according to the disclosed concepts provides reduced frictional resistance against the gasket along the gasket's path of travel as compared to the prior art. Optionally, in any embodiment, the surface area of ​​the contact surface 128, 228, 328, 428 is less than 75%, optionally less than 65%, optionally less than 50%, optionally less than 40%, optionally less than 30%, optionally between 15% and 50%, or optionally between 25% and 50% of the total surface area of ​​the interior wall 126, 226, 326, 426.

[0056] Thus, optionally, in any embodiment, the inner wall 126, 226, 326, 426 is not perfectly round.

[0057] The exact geometric configuration of the contact surface 128, 228, 328, 428 may vary depending on the application, the relative size and material of the gasket used, and other factors. Optionally, the contact surface 128, 228, 328, 428 may include two or more guide rails 132, 232, 332, 432 that project radially inward from the non-contact surface 130, 230, 330, 430 and extend axially along the length of the lumen 124, 224, 324, 424. The guide rails 132, 232, 332, 432 are preferably evenly spaced from one another to stabilize the gasket as it advances down the supply tube 120, 220, 320, 420. The guide rails 132, 232, 332, 432 are configured to provide a reduced area sliding surface for a gasket advancing down the lumen 124, 224, 324, 424. Optionally, the guide rails 132, 232, 332, 432 provide inwardly or outwardly rounded contact surfaces 128, 228, 328, 428. For example, the contact surfaces 128, 228 are convex and the contact surfaces 328, 428 are concave. The number of guide rails 132, 232, 332, 432 may vary as well, as shown in the different exemplary embodiments.

[0058] To further minimize friction, the contact surfaces 128, 228, 328, 428 should have a low surface roughness and, optionally, include a low surface energy surface coating disposed thereon. This may be done using a wide range of materials. For example, a thin surface coating having low surface energy can be added using a "baked-on" pharmaceutical grade coating, such as a selected sol-gel coating (ORMOCER® coating from the Fraunhofer Institute), or other suitable permanently bonded non-stick coating.

[0059] ORMOCER® coatings, which are organically modified ceramic polymers, are understood to be inorganic-organic hydride polymers. These are silicone polymers known as coating materials for metals, glass, stone, etc. The preparation and composition of inorganic-organic hybrid polymers are described, for example, in DE 4303570C and EP 0610831 B1, both of which are incorporated herein by reference in their entirety.

[0060] Optionally, the ORMOCER® coating is a hybrid organic-inorganic polymeric coating comprising, consisting essentially of, or consisting of: (i) the formula R having the following meaning: m Six 4-m a hydrolysis condensate prepared from the silane of Having a metal compound, R = crosslinkable organic radical X=hydrolyzable group and condensable group m=1 or 2 or 3 (1 is preferred) (ii) a prepolymer crosslinkable with a silane radical R; (iii) one or more (particularly one or two) optional non-crosslinkable organofunctional silanes, and (iv) An optional low volatility oxide.

[0061] Alternatively, the inner wall may have or otherwise include a coating of a polymer having low surface energy, which may include a member selected from the group consisting of fluorinated polymers, optionally fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), and perfluoroalkoxy (PFA).

[0062] The non-stick coating preferably withstands typical sterilization methods, particularly autoclaving, gassing, and / or radiation. The coating should also be suitable for medical use, biocompatible, and cytotoxin-free. The coating should also be of a certain nature and applied in a manner that prevents peeling. It is contemplated that the reduced contact surface area and low surface energy coating eliminate the need for silicone oil or other mobile lubricants. In this regard, the disclosed concept provides an oil-free solution.

[0063] Syringes and syringe plungers (gaskets) are often constructed according to ISO standards. Thus, it is possible to manufacture devices that include a supply tube to accommodate a variety of standard sizes of medical barrels and gaskets. The supply tubes 120, 220, 320, 420 described herein are typically part of a larger machine that precisely positions one or more syringes down a series of one or more gasket insertion devices, which then deliver and insert the gaskets into the pre-filled syringes. The basic function of this system is to insert a gasket (also called a plunger, piston or stopper) into a filled syringe. The syringe is filled with a liquid medium, e.g., a liquid pharmaceutical. The main functional elements of this insertion are a gasket supply tube and a gasket ram. Each functional element is moved relative to each other, for example, by a mechanical cam, servo motor, or robot according to a specific timing. The gasket insertion system includes one plunger supply tube and a gasket ram for positioning and sealing one syringe at a time, or one or more sets for sealing two or more syringes simultaneously.

[0064] For a system for placing and sealing a single gasket in a single syringe, the system operates as follows: A gasket is placed concentrically above a supply tube. Vertical movement of the gasket ram inserts the gasket into the supply tube. The gasket is slightly compressed and therefore held by a slight interference fit within the supply tube. The gasket ram then advances the gasket down the supply tube and into the medical barrel to a predetermined depth. The supply tube then begins to move upward, followed by upward movement of the gasket ram to eject the gasket above the fill level in the medical barrel. The gasket ram and supply tube move to their respective home positions to restart the process with a new gasket and medical barrel. Alternatively, using a more simplified machine, a gasket insertion system could use a vacuum to assist in the insertion of the gasket, as described above in the background section.

[0065] Optional gasket for use in a supply pipe according to the disclosed concepts The gasket used in conjunction with the supply tubes 120, 220, 320, 420 is optionally any gasket suitable for feeding a syringe through the supply tube, such as conventional gaskets in the art.

[0066] Optionally, the gasket used in conjunction with the supply tube 120, 220, 320, 420 is a gasket having one or more channels along a circumferential surface portion of at least one gasket rib, optionally a distal rib, adjacent the gasket nosecone. Preferably, such channels are non-continuous, i.e., do not extend a full 360 degrees around the circumference of the rib.

[0067] In one aspect of a gasket that may optionally have channels along the sides of the gasket and be used in conjunction with a feeding tube according to the disclosed concept, the gasket is as described above, which was developed internally by the applicant and gave rise to the applicant's recognition of the need for innovation in the configuration of the feeding tube. In summary, the gasket has a circumferential surface portion along the gasket sidewall and a film present on at least a portion of the circumferential outer surface portion of the gasket. The film is optionally a fluoropolymer film to promote the sliding properties of the gasket both during feeding and in use for dispensing the syringe contents. The gasket includes an internal cavity at its center. The gasket features a plurality of non-continuous channels in or through the film, each non-continuous channel being approximately parallel to the other non-continuous channels. Each non-continuous channel of the plurality of non-continuous channels has a non-channel portion that extends around the circumferential outer surface of the gasket and interrupts the non-continuous channel. The non-channel portions of each non-contiguous channel are positioned along the circumferential outer surface portion of the gasket such that they are not aligned with the non-channel portions of the immediately adjacent non-contiguous channel or channels.

[0068] Further details regarding optional gaskets that may be used in conjunction with the supply tubes 120, 220, 320, 420 in accordance with the disclosed concepts will now be provided with reference to Figures 1-5B.

[0069] 1 illustrates a syringe 10 of the present disclosure that includes a hollow, cylindrical syringe barrel 12, a plunger rod 26 coupled to and reciprocable within the syringe barrel 12, and a gasket 14 attached to a distal end of the plunger rod 26. The syringe barrel 12 can be similar, substantially similar, or identical to the medical barrel 1012 described above.

[0070] As used herein, the terms "distal" and "proximal" generally refer to a spatial or positional relationship relative to a given reference point, where "proximal" is a position at or relatively close to that reference point, and "distal" is a position further away from that reference point. When applied herein to plunger rod 26, for example, the relevant reference point is the bottom end of plunger rod 26, the distal end attached to gasket 14. When applied herein to syringe barrel 12, for example, the relevant reference point is the bottom end of barrel 12, the distal end attached to a delivery conduit or hypodermic needle.

[0071] Syringe 10 includes a hollow barrel 12, generally of conventional construction and material, preferably plastic, having a central longitudinal axis. The barrel has an interior surface 14 and is configured to hold an injectable liquid therein. A hypodermic needle or delivery conduit is located at the distal end of the barrel and in fluid communication therewith. A plunger rod 26 is also generally of conventional construction and material. A gasket 14 of the present disclosure (shown diagrammatically in FIG. 1) is attached to the distal end of plunger rod 26.

[0072] FIG. 2 shows a fragmentary detail view of the syringe of FIG. 1 showing the inside diameter (ID) of the barrel 12 and the outside diameter (OD) of the gasket 14 conforming within a predetermined tolerance therebetween, and shows the film 16 covering the outer surface of the gasket core 18. The gasket 14 preferably includes a nose cone 27 at its distal end and one or more ribs 19a, 19b, 19c that project radially outward (relative to the central axis of the gasket) from the sidewall of the gasket 14 to engage and provide a liquid-tight and / or air-tight seal between the gasket 14 and the barrel 12. In embodiments with at least two ribs, valleys 13a, 13b separate each such rib. Such a configuration provides the surface contact and compression via the ribs (e.g., 19a, 19b, 19c) necessary for a good seal to protect the quality of the pharmaceutical product contained within the syringe 10. At the same time, the valleys (e.g., 13a, 13b), which have a smaller outer diameter than the ribs (e.g., 19a, 19b, 19c), provide areas of relatively reduced compression, or no contact or compression, with the barrel 12. Thus, the ribs and valleys balance the competing goals of providing a good seal without excessive compression / friction to allow for a reasonably low and consistent plunger force when the plunger rod 26 is depressed distally of the barrel 12 to dispense the contents of the syringe 10.

[0073] In one optional aspect of the disclosed concept, at least one non-continuous channel extends around the outer surface of the gasket. For example, a first non-continuous channel 20 extends around the circumferential outer surface of the gasket core 18, and a second non-continuous channel 21 extends around the circumferential outer surface of the gasket core 18. The second non-continuous channel 21 is optionally approximately parallel to the first non-continuous channel 20 (i.e., in a parallel plane with each other). It is preferred that the channel or channels (e.g., 20 and 21) are provided on a rib (e.g., 19a, 19b and / or 19c) of the gasket 14, more preferably on the distal rib 19a or only on the distal rib 19a.

[0074] 3A is a schematic cross-sectional view taken along section line 3A-3A in FIG. 2 and shows the gasket core 18 in the internal cavity (IC), the film 16, a first non-continuous channel 20 in the film surface (in some embodiments, the channel 20 extends through the film to the outer surface of the gasket), and a second non-continuous channel 21 in the film surface (in some embodiments, the channel 21 extends through the film to the outer surface of the gasket) that is approximately parallel to the first non-continuous channel 20. As shown in this optional embodiment, the non-continuous channels 20, 21 are located on the distal rib 19a.

[0075] 3B is a detailed view of a portion of the structure of FIG. 3A and illustrates one embodiment of each of first non-continuous channel 20 and second non-continuous channel 21 that extend around the circumferential outer surface of gasket core 18. As shown, second non-continuous channel 21 is generally parallel to first non-continuous channel 20 and lips 22 and 24 on each side of channel 20.

[0076] FIG. 3C shows a top view of the gasket 14 and also shows the approximate geometric distribution of the first non-continuous channels 20 extending around the circumferential outer surface of the gasket core 18 and the approximate geometric distribution of the second non-continuous channels 21 extending around the circumferential outer surface of the gasket core 18. This top view is intended to be illustrative of the location of the non-channel portion of each non-continuous channel of the plurality of non-continuous channels. Thus, each non-continuous layer includes a non-channel portion (21a, 20a) associated with the respective non-continuous layer (21, 20). The non-channel portions (21a, 20a) are not aligned with each other on the circumferential outer surface portion of the gasket. Although FIG. 3C illustrates the non-channel portion of the first non-continuous channel positioned 180 degrees from the non-channel portion of the adjacent non-continuous channel around the circumference of the gasket 14, the non-channel portion may be located at alternative locations around the circumference of the gasket 14, so long as the adjacent non-channel portions are not aligned. For example, the non-channel portions of the first non-continuous channel are disposed in a range of 90 degrees to 270 degrees from adjacent non-channel portions along the circumference of the gasket, and the adjacent non-channel portions are not aligned. In a preferred embodiment, the non-channel portions of the first non-continuous channel may be positioned approximately 180 degrees from adjacent non-channel portions around the circumference of the gasket.

[0077] Optionally, in another embodiment, each non-contiguous channel may include multiple non-channel portions disposed about the periphery such that the non-contiguous channels may be a "dashed line" of channel and non-channel portions. Adjacent non-contiguous channels may be "dashed" channels of channel and non-channel portions. The channel and non-channel portions of adjacent non-contiguous channels may be positioned about the periphery of the gasket as long as the adjacent non-channel portions are not aligned.

[0078] 3D shows a top view of an optional embodiment of a gasket and the approximate geometric distribution of three non-continuous channels 20, 21, 23 extending around the circumferential outer surface of the gasket core. This top view is intended to be illustrative of the location of the non-channel portion of each of the non-continuous channels 20, 21, 23 of the plurality of non-continuous channels. Each of the channels 20, 21, 23 extends around the circumferential surface of the gasket and each has a portion that does not include a channel. The three non-continuous channels 20, 21, 23 are axially spaced apart from one another, with the non-continuous channel 20 being positioned closer to the top of the gasket than the other two non-continuous channels 21 and 23, the non-continuous channel 21 being adjacent to the non-continuous channel 20 and distal to the top of the gasket compared to the non-continuous channel 20, and the non-continuous channel 23 being adjacent to the non-continuous channel 21 and distal to the top of the gasket compared to the non-continuous channel 21. Each of the non-continuous channels 20, 21, 23 includes a non-channel portion (20a, 21a, 23a) associated with the non-continuous channel 20, 21, 23. The non-channel portions (20a, 21a, 23a) are positioned so as not to align with the non-channel portions of adjacent non-continuous channels along a circumferential outer surface portion of the gasket. In some embodiments, the non-channel portion of one non-continuous channel may align with the non-channel portion of a non-adjacent non-continuous channel. This is illustrated in the relative position of non-channel portion 20a compared to the relative position of non-channel portion 23a.

[0079] The channels may be formed by laser cutting. FIG. 4A shows a schematic diagram of the laser cutting process in one optional embodiment of the present disclosure. As shown, a laser beam 17 is applied to a circumferential surface portion of a gasket 14 fixed on a mandrel 28 at a desired angle. The angle at which the laser beam 17 is applied may be 5 degrees to 90 degrees from the surface portion of the gasket 14. For the formation of channels in at least a portion of the circumferential surface portion of the gasket 14, a laser beam source 15 is fixed relative to the circumferential surface portion of the gasket 14 having a film 16 present on the outer surface of the gasket 14, and the laser beam 17 is applied to the circumferential surface portion while the gasket 14 fixed on the mandrel 28 rotates about its longitudinal axis. Thus, the laser beam 17 may be applied to any angular position of the circumferential surface portion at a predetermined incidence angle α (e.g., 5° to 90°), thereby forming the channels uniformly.

[0080] While laser beam 17 is applied obliquely to the circumferential surface portion, the gasket may be rotated in a direction such that the circumferential surface portion moves away from the laser beam application location where laser beam 17 is applied. Optionally, the gasket may be rotated clockwise, for example as shown in FIG. 4A.

[0081] 4B shows a schematic cross-sectional view of gasket 14 of 4A taken along section line 4B-4B. As shown, film 16 is present on gasket 14 and has first non-continuous channels 20 and second non-continuous channels 21 on the outer surface of film 16.

[0082] Figure 5A shows a gasket 14 having a film 16 with a first non-continuous channel 20 within the film 16. Figure 5B shows a fragmentary detail view of the structure of Figure 5A, illustrating an embodiment of the first non-continuous channel 20 in the surface of the film with lips 22 and 24 on either side of the first non-continuous channel 20, and showing various dimensions of the first non-continuous channel 20 and the lips 22 and 24, including peak width, axial width, laser cut depth, and radial depth (as these terms are defined above). In another more preferred embodiment, the first non-continuous channel 20 extends through the film 16 to the outer surface of the gasket 14.

[0083] By performing the laser cutting process described above, channels are formed substantially uniformly within film 16 and preferably extend within the circumferential surface portion of the gasket, while simultaneously forming peripheral portions 22 and 24, as shown in FIG. 5B.

[0084] Optional method of providing a gasket according to the disclosed concepts to a medical barrel In an optional aspect, a method of providing a gasket to a medical barrel is provided, the method comprising: Providing a supply conduit 120, 220, 320, 420 according to any embodiment of the disclosed concepts; placing a gasket having an outer wall (circumferential surface portion) within the supply tube 120, 220, 320, 420 in the lumen 124, 224, 324, 424 such that a compression and / or interference fit between the outer wall and the contact surface 128, 228, 328, 428 holds the gasket in place within the lumen 124, 224, 324, 424; aligning the supply tube 120, 220, 320, 420 with the proximal open end of the medical barrel; sliding the gasket through the supply tube 120, 220, 320, 420 so that the outer wall of the gasket only contacts the contact surface of the inner wall 126, 226, 326, 426 and not the entirety of the inner wall; Moving the gasket from the supply tube 120, 220, 320, 420 into the medical barrel.

[0085] Optionally, use of the delivery tubes 120, 220, 320, 420 disclosed herein does not introduce any mobile lubricant particles into the syringe.

[0086] Optionally, in any embodiment, the gasket supplied through the supply tube is a gasket selected from any embodiment disclosed herein or a conventional gasket in the art.

[0087] Thus, the disclosed concepts provide a modified feed tube that is inherently low friction. As disclosed herein, the use of two or more guide rails defines the contact surface and axial travel path of the gasket instead of full surface contact with the tube.

[0088] Exemplary embodiments The following exemplary embodiments further describe optional aspects of the technology of the present disclosure and are part of the detailed description. These exemplary embodiments are not technical claims of the present application, but are described in a format substantially similar to the claims. The following exemplary embodiments refer to each other in a dependent relationship as "embodiments" instead of "claims".

[0089] 1A. A tube for holding and delivering a syringe gasket to a medical barrel, the tube comprising an elongated hollow tubular body including an internal lumen, the lumen having an inner wall including a contact surface configured to contact an outer wall of the gasket, the contact surface optionally having a surface area less than the surface area of ​​the inner wall, the surface area being less than 75% of that of the inner wall, optionally less than 65%, optionally less than 50%, optionally less than 40%, optionally less than 30%, optionally between 15% and 50%, or optionally between 25% and 50% of that of the inner wall.

[0090] 1B. A tube for holding and delivering a syringe gasket within a medical barrel, the tube including an elongated hollow tubular body including an internal lumen, the lumen having an inner wall including a contact surface configured to contact an outer wall of the gasket, the contact surface including two or more guide rails extending axially along the lumen.

[0091] 1C. The tube of embodiment 1A or 1B, wherein the tube is composed of or comprises a polymer or metal.

[0092] 2C. The tube of embodiment 1C, wherein the tube is composed of or comprises a polymer selected from the group consisting of polyoxymethylene homopolymer, polyoxymethylene copolymer polystyrene, polycarbonate, polypropylene, polyethylene, polytetrafluoroethylene, ethylene tetrafluoroethylene, and any combination of the foregoing.

[0093] 3C. The tube of embodiment 2C, wherein the tube is composed of or comprises a polyoxymethylene homopolymer.

[0094] 4C. The tube of embodiment 3C, wherein the tube further comprises polytetrafluoroethylene.

[0095] 5C. The tubing of embodiment 4C, wherein the polyoxymethylene homopolymer and polytetrafluoroethylene are each melted and then homogeneously blended together.

[0096] 6C. The tubing of embodiment 4C, wherein the polyoxymethylene homopolymer is melted and then the polytetrafluoroethylene fibers are homogeneously blended with the polyoxymethylene homopolymer.

[0097] 1D. The tube of any one of embodiments 1A, 1B, and 1C-6C, wherein the contact surface comprises a surface coating or a material having low surface energy.

[0098] 2D. The tube of embodiment 1D, wherein the surface coating comprises a sol-gel coating.

[0099] 3D. The tube of embodiment 1D, wherein the surface coating comprises a hybrid organic-inorganic polymeric coating, optionally an ORMOCER® coating from the Fraunhofer Institute, as described herein.

[0100] 4D. The tube of embodiment 1D, wherein the surface coating or material comprises a member selected from the group consisting of fluorinated polymers, optionally fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), and perfluoroalkoxy (PFA).

[0101] 1E. A method of providing a gasket to a medical barrel, comprising: providing a tube according to any one of configurations 1A, 1B, 1C-6C, and 1D-4D; positioning a gasket having an outer wall within the tube within the lumen such that compression of the outer wall against a contact surface holds the gasket in place within the lumen; aligning the tube with a proximal open end of the medical barrel; sliding the gasket through the tube so that the outer wall of the gasket only contacts the contact surface without contacting the entire inner wall; moving the gasket from the tube into the medical barrel.

[0102] 2E. The gasket is (a) a body made of a resilient material and having a circumferential surface portion and an interior cavity, the cavity being defined by an inner surface portion of a gasket, one end of the cavity being open; (b) a film over at least a portion of the circumferential outer portion of the gasket; and (c) a plurality of non-continuous channels in or through the film generally parallel to other non-continuous channels, each non-continuous channel of the plurality of non-continuous channels extending around a circumferential outer surface of the gasket and having a non-channel portion interrupting the non-continuous channel; The method of embodiment 1E, wherein the non-channel portion of each non-contiguous channel is positioned along the circumferential outer surface portion of the gasket such that it is not aligned with the non-channel portions of the immediately adjacent non-contiguous channel or channels.

[0103] 3E. A gasket is formed by a process for forming a plurality of non-contiguous channels in or through a film present on at least a portion of a circumferential outer surface portion of the gasket, the process comprising: (a) inserting a portion of one end of a mandrel into an open end of a cavity; (b) positioning the mandrel and gasket in proximity to a laser; (c) applying a laser beam emitted from the laser to a plurality of selected locations on a surface portion of the film while rotating the mandrel and gasket along a longitudinal axis of the mandrel to form a plurality of non-contiguous channels in or through the film, each non-contiguous channel being generally parallel to the other non-contiguous channels, each non-contiguous channel of the plurality of non-contiguous channels extending around a circumferential outer surface of the gasket and having a non-channel portion interrupting the non-contiguous channel; The method of embodiment 2E, wherein the non-channel portion of each non-contiguous channel is positioned along the circumferential outer surface portion of the gasket such that it is not aligned with the non-channel portions of the immediately adjacent non-contiguous channel or channels.

[0104] 4E. The method of any one of embodiments 1E-3E, wherein the method is performed without any mobile lubricant between the gasket and the tube.

[0105] While the present invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.

Claims

1. A system for supplying syringe gaskets to a medical barrel, wherein the system is a. A gasket configured for insertion into a medical barrel, wherein the gasket comprises a body made of an elastic material, the gasket having a distal nose cone configured to face a product stored in the medical barrel when inserted into the medical barrel, and a circumferential surface portion extending proximal to the nose cone, the gasket having at least a portion of the circumferential surface portion configured to contact the inner side wall of the medical barrel by compression engagement, b. A tube for holding the gasket and then supplying the gasket into the medical barrel, wherein the tube comprises an elongated hollow tubular body including an internal lumen, the lumen having an inner wall, the inner wall comprising a contact surface configured to contact a portion of the circumferential surface portion of the gasket, and a non-contact surface occupying the remaining portion of the inner wall, Includes, Along a selected plane perpendicular to the central axis of the pipe, a first portion of the circumferential surface portion of the gasket contacts and compressively engages with the contact surface, while a second portion of the circumferential surface portion of the gasket, (i) Not in contact with the non-contact portion, or (ii) Contact with the non-contact portion, but with less compression on the non-contact portion than the compression present between the first portion of the circumferential surface portion of the gasket and the contact surface. A system in which the gasket is placed inside the pipe.

2. A system for supplying syringe gaskets to a medical barrel, wherein the system is a. A gasket configured for insertion into a medical barrel, wherein the gasket comprises a body made of an elastic material, the gasket having a distal nose cone configured to face a product stored in the medical barrel when inserted into the medical barrel, and a circumferential surface portion extending proximal to the nose cone, the gasket having at least a portion of the circumferential surface portion configured to contact the inner side wall of the medical barrel by compression engagement, b. A tube for holding the gasket and then supplying the gasket into the medical barrel, wherein the tube comprises an elongated hollow tubular body including an internal lumen, the lumen having an inner wall, the inner wall comprising a contact surface configured to contact a portion of the circumferential surface portion of the gasket, and a non-contact surface occupying the remaining portion of the inner wall, the contact surface comprising two or more guide rails extending axially along the lumen, Includes, Along a selected plane perpendicular to the central axis of the pipe, a first portion of the circumferential surface portion of the gasket contacts and compressively engages with the two or more guide rails, while a second portion of the circumferential surface portion of the gasket, (i) Not in contact with the non-contact portion, or (ii) Contact with the non-contact portion, but with less compression on the non-contact portion than the compression present between the first portion of the circumferential surface portion of the gasket and the two or more guide rails. A system in which the gasket is placed inside the pipe.

3. A method for supplying a syringe gasket to a medical barrel, wherein the method is a. To provide a gasket configured for insertion into a medical barrel, wherein the gasket comprises a body made of an elastic material, the gasket having a distal nose cone configured to face a product stored in the medical barrel when inserted into the medical barrel, and a circumferential surface portion extending proximal to the nose cone, wherein at least a portion of the circumferential surface portion is configured to contact the inner side wall of the medical barrel by compression engagement, b. Providing a tube for holding the gasket and then supplying the gasket into the medical barrel, wherein the tube comprises an elongated hollow tubular body including an internal lumen, the lumen having an inner wall, the inner wall comprising a contact surface configured to contact a portion of the circumferential surface portion of the gasket, and a non-contact surface occupying the remaining portion of the inner wall, c. Along a selected plane perpendicular to the central axis of the pipe, a first portion of the circumferential surface portion of the gasket contacts and compressively engages with the contact surface, while a second portion of the circumferential surface portion of the gasket, (i) Not in contact with the non-contact portion, or (ii) Contact with the non-contact portion, but with less compression on the non-contact portion than the compression present between the first portion of the circumferential surface portion of the gasket and the contact surface. Thus, the gasket is fixed inside the pipe, d. Aligning the tube with the proximal open end of the medical barrel, e. The gasket is slid through the pipe, such that the contact and compression between the circumferential surface portion of the gasket and the inner wall of the lumen are maintained as the gasket slides through the pipe, as enumerated in step (c). f. Transferring the gasket from the pipe to the medical barrel, Methods that include...

4. A method for supplying a syringe gasket to a medical barrel, wherein the method is a. To provide a gasket configured for insertion into a medical barrel, wherein the gasket comprises a body made of an elastic material, the gasket having a distal nose cone configured to face a product stored in the medical barrel when inserted into the medical barrel, and a circumferential surface portion extending proximal to the nose cone, wherein at least a portion of the circumferential surface portion is configured to contact the inner side wall of the medical barrel by compression engagement, b. Providing a tube for holding the gasket and then supplying the gasket into the medical barrel, wherein the tube comprises an elongated hollow tubular body including an internal lumen, the lumen having an inner wall, the inner wall comprising a contact surface configured to contact a portion of the circumferential surface portion of the gasket, and a non-contact surface occupying the remaining portion of the inner wall, the contact surface comprising two or more guide rails extending axially along the lumen, c. Along a selected plane perpendicular to the central axis of the pipe, a first portion of the circumferential surface portion of the gasket contacts and compressively engages with the two or more guide rails, while a second portion of the circumferential surface portion of the gasket, (i) Not in contact with the non-contact portion, or (ii) Contact with the non-contact portion, but with less compression on the non-contact portion than the compression present between the first portion of the circumferential surface portion of the gasket and the two or more guide rails. Thus, the gasket is fixed inside the pipe, d. Aligning the tube with the proximal open end of the medical barrel, e. The gasket is slid through the pipe, such that the contact and compression between the circumferential surface portion of the gasket and the inner wall of the lumen are maintained as the gasket slides through the pipe, as enumerated in step (c). f. Transferring the gasket from the pipe to the medical barrel, Methods that include...

5. The method according to claim 4, wherein the contact surface has a surface area smaller than the surface area of ​​the inner wall.

6. The method according to claim 4, wherein the guide rail is rounded outward along the cross-sectional plane.

7. The method according to claim 4, wherein the guide rail is curved inward along the cross-sectional plane.

8. The method according to claim 4, wherein the contact surface includes two to eight guide rails.

9. The method according to claim 4, wherein the contact surface comprises an even number of guide rails, each guide rail facing another guide rail located 180 degrees therefrom around the lumen.

10. The system according to claim 2, further comprising a medical barrel whose proximal end is aligned with the pipe and which is configured to receive the gasket from the pipe at this position.

11. The method according to claim 4, wherein the contact surface includes a surface coating having a low surface energy.

12. The method according to claim 11, wherein the surface coating includes a sol-gel coating.

13. The method according to claim 11, wherein the surface coating comprises an inorganic-organic hydride polymer.

14. The aforementioned surface coating a. A hydrolysis condensate prepared from a silane of formula R m SiX 4-m having a metal compound, wherein the formula is as follows: R = Crosslinkable organic radical, X = hydrolyzable group and condensable group, m = 1, 2, or 3 Hydrolyzed condensates have the meaning of, b. A prepolymer that can be crosslinked with the silane radical R, c. One or more non-crosslinkable organic functional silanes, d. Low-volatility oxides and The method according to claim 13, including the method described in claim 13.

15. The method according to claim 11, wherein the surface coating comprises a fluorinated polymer which is a member selected from the group consisting of fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), and perfluoroalkoxy (PFA).

16. The method according to claim 4, wherein the tube is made of a polyoxymethylene homopolymer, polytetrafluoroethylene, or a molten mixture of the two.

17. The method according to claim 4, wherein the tube is made of a polyoxymethylene homopolymer having polytetrafluoroethylene fibers uniformly blended in the polyoxymethylene homopolymer.

18. The method according to claim 4, wherein the circumferential surface portion of the gasket includes one or more ribs that project radially outward and are configured to engage between the gasket and the medical barrel in which the gasket is placed and to provide a seal, and at least one of the one or more ribs includes one or more channels that extend along at least a portion of the circumference of at least one of the one or more ribs.

19. The method according to claim 18, wherein the one or more ribs include a distal rib adjacent to the nose cone, and the one or more channels are provided on the distal rib.

20. The method according to claim 18, wherein one or more of the channels are laser-cut.

21. The method according to claim 18, wherein one or more of the channels are discontinuous.

22. The method according to claim 4, wherein the gasket includes a film present on at least a portion of the outer circumference of the gasket.

23. The aforementioned gasket a. The body including an internal cavity, wherein the cavity is defined by the inner surface portion of the gasket and is an open end at one end, b. A film present on at least a portion of the circumferential surface of the gasket, c. A plurality of discontinuous channels in or through a film substantially parallel to other discontinuous channels, wherein each of the plurality of discontinuous channels has a discontinuous portion that extends around the outer circumferential surface of the gasket and interrupts the discontinuous channel, Includes, The method according to claim 4, wherein the non-channel portion of each discontinuous channel is positioned along the outer circumferential surface portion of the gasket such that it does not align with the non-channel portion of an immediately adjacent discontinuous channel.

24. The method according to claim 23, wherein the plurality of discontinuous channels are provided on the ribs of the gasket.

25. The method according to claim 4, wherein there is no fluid lubricant in the pipe.

26. The method according to claim 24, wherein the rib is a distal rib adjacent to the nose cone.

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