WO2006064753A1 - Cloison artificielle, port sans aiguille associe a cette cloison artificielle, et methode de fabrication de cette cloison artificielle et de ce port sans aiguille - Google Patents

Cloison artificielle, port sans aiguille associe a cette cloison artificielle, et methode de fabrication de cette cloison artificielle et de ce port sans aiguille Download PDF

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Publication number
WO2006064753A1
WO2006064753A1 PCT/JP2005/022754 JP2005022754W WO2006064753A1 WO 2006064753 A1 WO2006064753 A1 WO 2006064753A1 JP 2005022754 W JP2005022754 W JP 2005022754W WO 2006064753 A1 WO2006064753 A1 WO 2006064753A1
Authority
WO
WIPO (PCT)
Prior art keywords
septum
outer end
end surface
surface side
inner end
Prior art date
Application number
PCT/JP2005/022754
Other languages
English (en)
Japanese (ja)
Inventor
Ryoji Fujii
Original Assignee
Jms.Co., Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jms.Co., Ltd filed Critical Jms.Co., Ltd
Priority to JP2006548817A priority Critical patent/JP4940951B2/ja
Publication of WO2006064753A1 publication Critical patent/WO2006064753A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer

Definitions

  • the present invention relates to a septum that is attached to a flow path of a chemical solution and has a blunt tip such as a luer syringe or a luer lock syringe, and an insert can be inserted therein. Regarding the method.
  • blunt tips such as luer syringes or luer lock syringes
  • the needle with a blunt tip is configured in combination with a port into which the needle can be inserted (hereinafter referred to as “needleless port”), and is a combination exclusively for each other.
  • needleless port a port into which the needle can be inserted
  • a luer lock syringe may be inserted when it is difficult to securely hold the lure syringe during insertion.
  • a lure syringe and a luer lock syringe have a structure in which any one of the lure lock syringes can be inserted—a one dollar relief port is being developed.
  • a port disclosed in US Pat. No. 6,089,541 is mounted such that a deformable septum is movable within the main body, and the inside of the septum has a hollow structure except for the opening. Inserting an insert such as a lure into the septum opening provides fluid communication.
  • a male screw for screw locking is formed near the opening of the main body so that a luer lock syringe can be inserted.
  • 5699821 has a deformable longitudinal tubular septum mounted so as to be slidable within the main body, and by inserting an insert such as a luer into the opening of the septum. Liquid communication. In the vertically long septum, a flow path is formed inside, and the flow path is opened in a natural state, that is, before being attached to the port body. And when attached to the main body, it functions as a septum by compressing the entrance (exit).
  • a screw lock is provided near the opening of the main body so that a luer lock syringe can also be inserted.
  • the male screw is formed.
  • the port disclosed in U.S. Pat. No. 5,474,544 has a deformable septum mounted in the body so that it can be expanded. By inserting an insert such as a lure into the opening of the septum, liquid communication is achieved, and the inside of the port is filled by deformation of the septum itself, thereby preventing liquid leakage.
  • a male screw for screw locking is formed near the opening of the main body so that a luer lock syringe can be inserted.
  • the conventional one-dollarless port as described above, especially a luer lock syringe can also be inserted.
  • the inertial plug body (hereinafter referred to as a septum) constituting the one-dollarless port satisfies the following characteristics. It can be requested!
  • a septum made of soft and rubber has a problem of low pressure resistance and low airtightness.
  • the rubber material constituting the septum is a rubber material that satisfies the requirements of flexibility and slipperiness suitable for inserting an insert into the septum, and also the requirements of airtightness. The current situation is that the raw materials are not.
  • a septum is formed of a flexible elastic rubber, and silicon oil is applied to the surface of the septum in order to further improve the slipperiness of the rubber.
  • the septum coated with silicone oil has no problem in terms of initial performance, the port part is usually wiped off before use, for example, with sterilized cotton, so this operation removes the silicone oil. The insertability gradually deteriorates.
  • the present inventor instead of applying the silicone oil, the present inventor had various effects as described in (1) to (3) below.
  • Lubricant blended into the rubber that forms the septum and the ability to bleed out the lubricant from the rubber and give the septum slidability as described above. Since it does not bleed out immediately on the surface, there is no effect until the lubricant bleeds out after wiping.
  • the coating does not follow the expansion and contraction of the rubber, so the silicone resin will peel off the septum body after several uses. It was difficult to eliminate the formed luer lock syringe dead space, and air bubbles stayed there, and there was a problem in safety during blood transfusion and infusion.
  • Patent Document 1 US Pat. No. 6089541
  • Patent Document 2 US Patent No. 5699821
  • Patent Document 3 US Pat. No. 5,474,544
  • the present invention aims to improve the properties of the above-mentioned (1) to (5) required for a septum into which an insert is inserted, and in particular, to improve the slip characteristics of the septum in order to facilitate the insertion of the insert into the septum. It is an object to solve the problem of achieving sufficient pressure resistance of the septum.
  • the present inventor has a through-passage that allows liquid to flow from the outer end surface side to the inner end surface side with the outer end surface side being a slit portion. And a layer for improving the slip characteristics of the septum to facilitate insertion of a luer lock connector or luer connector into the slit of the septum or an insert such as a luer syringe or luer lock syringe on the outer end surface side.
  • the above problem could be solved by providing a septum characterized in that it is formed.
  • the present invention employs means for forming a resin layer that facilitates the insertion of the insert into the slit portion on the outer end surface side of the septum as described above, whereby the slit is formed in the slit portion of the septum.
  • the layer for improving the slip characteristics of the septum in order to facilitate the insertion of the insert into the slit on the outer end surface side of the septum is to twist the septum when inserting the insert into the slit.
  • the outer end surface side of the septum referred to in the present invention is a luer syringe or luer lock syringe.
  • the surface portion of the septum body on the side where the insert such as the die is inserted is referred to, and the outer end surface side of the septum refers to the surface portion of the septum body opposite to the inner end surface side.
  • the through passage refers to a passage through which the outer end surface side force S, which is the outer end surface side force S slit portion, also penetrates toward the inner end surface side, and is configured by the entire through passage force slit portion. Or the one having only the outer end surface side having a hole portion that is continuous with the slit portion toward the inner end surface side.
  • the layer provided on the outer end face side of the septum may be any layer as long as it can achieve the above-mentioned purpose.
  • a layer formed by a CVD method constitutes a layer like a septum. Even if it is an article having flexibility such as rubber, for example, by adjusting the thickness of the layer to be formed, the inherent flexibility of the septum is not lost, and the slit of the septum of the insert is not lost.
  • the layer forming means that can be employed in the present invention is not limited to the CVD method as long as it has the functions described above or can form a layer.
  • the layer formed by the CVD method is a polyparaxylene resin layer, which is an organic resin layer capable of sufficiently achieving the purpose of forming the layer, and is an inorganic layer.
  • DLC Diamond Like Carbon, diamond-like carbon
  • the polyparaxylene resin layer is formed by vaporizing diparaxylylene in a vaporization chamber by thermal CVD and forming diradical paraxylylene from the diparaxylylene force by thermal decomposition in the pyrolysis chamber.
  • the diradical paraxylylene can be simultaneously adsorbed on a septum and polymerized on a polyparaxylene resin.
  • Adsorption and polymerization of diradical paraxylylene on the septum in this vapor deposition chamber can be carried out using either tumble force as shown in Fig. 4 or static force as shown in Fig. 5. can do.
  • Formation of the DLC layer, which is an inorganic layer, by the CVD method can be performed by the plasma CVD method.
  • a raw material gas methane (CH 3), ethane generally used for carbon layer formation can be used. (CH), propane (CH), butane (CH), acetylene (CH), benzene (CH), etc.
  • the hydrocarbon compound gas of 2 6 3 8 4 10 2 2 6 6 and, if necessary, a mixture of these hydrocarbon compound gases with hydrogen gas, inert gas, etc. as a carrier gas can be used.
  • the septum is formed from a rubber material cover, when a fluorine-containing gas plasma is employed, the septum surface is terminated with fluorine, thereby improving the adhesion between the carbon layer to be formed and the septum. be able to.
  • oxygen gas plasma is employed, dirt such as organic matter adhering to the surface of the substrate can be removed particularly efficiently, and the adhesion of the carbon layer to be formed thereafter can be improved. Adhesion with the treated septum can be improved.
  • the polyparaxylene resin layer is formed on the entire septum.
  • the polyparaxylene resin layer is formed on the inner end face side of the septum and the inner surface of the hole layer, but the polyparaxylene resin layer is formed on the septum surface, which is usually formed of a rubber material which is an elastic material.
  • the surface of the rubber constituting the septum is slightly cured, and irregularities are formed, resulting in a rough surface and a poor sealing property.
  • the same phenomenon occurs when the DLC layer is formed on the inner end face side of the septum and the inner surface of the hole layer.
  • a polyparaxylene resin layer formed by thermal CVD can be applied by, for example, masking the inner end surface of a septum with a masking material such as a masking tape and storing it in a deposition chamber.
  • a septum support base for example, a turntable, is provided in the vapor deposition chamber used in the carcass method, and the septum is placed on the turntable with the inner end face side of the septum facing down to perform static carburizing.
  • the layer can be formed on the inner end surface side, the side surface side excluding the inner surface of the hole portion, and the outer end surface side for the purpose of forming the layer as described above. If it is desired to form a layer only on the outer end face side of the septum, the layer may be formed by masking not only the inner end face side but also the side face side.
  • the thickness of the layer formed on the outer end face side of the septum is preferably 1 to 7 / ⁇ ⁇ , more preferably 2 to 6 / ⁇ ⁇ .
  • the septum satisfies the requirement of the thickness of the resin layer, as is apparent from Table 1, the needleless port assembled using the septum is excellent in insertion of a luer and a luer-locked syringe, It has excellent pressure resistance with no leakage from the slit of the septum and the inner end face.
  • the slit refers to a cut portion that is in a close contact state in a normal state and can maintain airtightness, and the hole is configured to have a space portion in a normal state, but the septum is configured as a needleless port or the like. When it is incorporated in, it refers to one that can form a slit state.
  • the polyparaxylene resin used in the present invention is commercially available as norene resin (trade name).
  • the parylene resin (trade name), parylene resin (melting point 280 ° C). Is particularly preferable because the purpose of forming the layer as described above can be more achieved.
  • the polyethylene resin N is represented by the following chemical formula (1).
  • poly (monochloro-low-xylene) represented by the following chemical formula 2 [parylene resin C (Trade name)], but when the septum is treated with this parylene resin C (trade name), the slip properties of the septum are the same as those of the noren resin N (trade name). Not enough compared to.
  • polyethylene resin usable in the present invention is not limited to the above (ii) and (Chemical Formula 2).
  • the effect of the present invention is that, before assembling the septum to the one-dollarless port, at least the outer end surface side is a slit portion and has a through passage that allows liquid to flow from the outer end surface side toward the inner end surface side.
  • the septum is capable of inserting and holding an insert such as a luer syringe or luer lock syringe, the displacement is also effective, but it has been difficult to solve the problems of the present invention with the conventional method.
  • the following septa are particularly effective.
  • a through passage is formed between the outer end surface side and the inner end surface side, which was previously filed by the present inventor shown in FIGS. 1 to 3, and formed on the main body portion and the side portion of the main body portion.
  • a septum having a compression rib (WO2004 / 020037),
  • Anti-twisting material for the septum to prevent twisting of the septum when inserting an insert, such as a luer lock syringe, into the needleless port for example, a donut shape with an irregular shape (a jagged shape) formed on the inner periphery
  • Septum twist prevention material on the outer end face side -Septa used for one dollarless port.
  • a material constituting the septum a material having general rubber-like elasticity is preferable, but a material having a hardness IS-A of 20 to 50 is particularly preferable. If the hardness IS-A is less than 20, the septum is less airtight and is too soft, and therefore the slippage of the insert is low, making it difficult to insert the insert. The insert becomes difficult to insert because it becomes hard.
  • Specific elastic materials constituting the septum include silicone rubber, isoprene rubber, synthetic rubber such as pill rubber and -tolyl rubber, or thermoplastic elastomer.
  • the high tear silicone rubber has a very good adhesion to the polyparaxylene resin and the septum formed from the rubber is not easily damaged by twisting when the insert is inserted into the septum.
  • the material constituting the septum of the present invention is extremely preferable.
  • FIG. 1 is a perspective view of a septum in which a through passage capable of passing liquid is formed between an outer end surface side and an inner end surface side, and has a main body portion and a compression rib formed on the side portion of the main body portion.
  • FIG. 2 is a cross-sectional view of the septum shown in FIG.
  • FIG. 3 is a cross-sectional view of a needleless port assembled using the septum shown in FIGS. 1 and 2.
  • FIG. 4 A diagram illustrating static force.
  • FIG. 5 is a diagram illustrating tumble processing.
  • It comprises a vaporization chamber for diparaxylylene, a thermal decomposition chamber for diparaxylylene, and a static processing vapor deposition chamber that simultaneously adsorbs and polymerizes the diradical paraxylylene formed in the thermal decomposition chamber shown in FIG.
  • a turntable is installed in the vapor deposition chamber of a CVD (chemical vapor deposition) device, and a septum having a structure as shown in FIGS. 1 to 3 formed of silicon rubber of JIS-A25 degrees on the turntable is provided on the inner end face side. Placed and stored with B facing down.
  • diradixyl paraxylylene from a thermal decomposition chamber is supplied into the vapor deposition chamber of the CVD (chemical vapor deposition) apparatus, and the radical is attached and polymerized on the septum by the static cage, and the outer end surface side of the septum.
  • a polyparaxylene resin layer was formed only on the surface on the side surface side and a dollarless port was assembled using the septum.
  • the above-described polyparaxylene resin layer--one dollarless port was tested for the pressure resistance of the septum and the insertion of the syringe into the septum. Table 2 shows the experimental results.
  • the polyparaxylene resin layer was applied to the septum in the same manner as in the previous example, except that the septum was not masked and a tumble force was used instead of static processing. Formed and used its septum-assembled a dollarless port. The needleless port was tested for the pressure resistance of the septum and the insertion property of the syringe into the septum. Table 2 shows the experimental results.
  • Thickness Insertability Material 8 "Rylene Pressure resistance
  • PPL in the column of insertability is a polypropylene luer syringe
  • PCL is a polycarbonate luer connector
  • PCLL is a polycarbonate luer lock connector.
  • Norylene refers to Parylene N (trade name).
  • parylene (trade name) layer thickness m) in Tables 1 and 2 above was determined using a separately prepared calibration curve (the relationship between the raw material and the film thickness was determined in advance).

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention vise à améliorer les caractéristiques requises pour une cloison artificielle dans laquelle est inséré un corps. En particulier, l'invention vise à améliorer la propriété coulissante de cette cloison artificielle afin de pouvoir insérer le corps susmentionné dans la cloison artificielle et de fournir une cloison artificielle présentant une résistance suffisante à la pression. Cette cloison artificielle est caractérisée en ce qu'elle comprend un passage traversant permettant un écoulement de liquide, d'une face d'extrémité extérieure présentant une partie fendue vers une face d'extrémité intérieure, et une couche pour améliorer la propriété coulissante sur la face d'extrémité extérieure formée sur la face d'extrémité extérieure pour faciliter l'insertion du corps susmentionné dans la partie de fente. Ce port sans aiguille comprend la cloison artificielle. La méthode de fabrication de la cloison artificielle est caractérisée en ce qu'au moins la face d'extrémité intérieure de la cloison artificielle présentant le passage est masquée pour former la couche permettant d'améliorer la propriété coulissante de la cloison artificielle pour faciliter l'insertion du corps dans la cloison artificielle, à l'exception au moins du passage traversant et de la face d'extrémité intérieure de la face d'extrémité extérieure, à l'aide d'une méthode de dépôt chimique en phase vapeur.
PCT/JP2005/022754 2004-12-13 2005-12-12 Cloison artificielle, port sans aiguille associe a cette cloison artificielle, et methode de fabrication de cette cloison artificielle et de ce port sans aiguille WO2006064753A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2006548817A JP4940951B2 (ja) 2004-12-13 2005-12-12 セプタム、該セプタムを有するニードルレスポートおよびそれらの製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2004359488 2004-12-13
JP2004-359488 2004-12-13

Publications (1)

Publication Number Publication Date
WO2006064753A1 true WO2006064753A1 (fr) 2006-06-22

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WO (1) WO2006064753A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010148757A (ja) * 2008-12-26 2010-07-08 Nipro Corp 医療用弁
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11276595A (ja) * 1998-03-31 1999-10-12 Nippon Zeon Co Ltd 医療用弁体および医療用挿入補助具
JP2001029447A (ja) * 1999-07-19 2001-02-06 Terumo Corp 体内埋め込み医療器
JP2003512098A (ja) * 1999-10-19 2003-04-02 ラザロフ，ミラディン 生体に適合性のある物品

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11276595A (ja) * 1998-03-31 1999-10-12 Nippon Zeon Co Ltd 医療用弁体および医療用挿入補助具
JP2001029447A (ja) * 1999-07-19 2001-02-06 Terumo Corp 体内埋め込み医療器
JP2003512098A (ja) * 1999-10-19 2003-04-02 ラザロフ，ミラディン 生体に適合性のある物品

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010148757A (ja) * 2008-12-26 2010-07-08 Nipro Corp 医療用弁
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port
USD885557S1 (en) 2017-09-06 2020-05-26 C. R. Bard, Inc. Implantable apheresis port
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same

Also Published As

Publication number Publication date
JPWO2006064753A1 (ja) 2008-06-12
JP4940951B2 (ja) 2012-05-30

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