WO2019188607A1 - Ensemble cathéter et embase de cathéter - Google Patents

Ensemble cathéter et embase de cathéter Download PDF

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Publication number
WO2019188607A1
WO2019188607A1 PCT/JP2019/011538 JP2019011538W WO2019188607A1 WO 2019188607 A1 WO2019188607 A1 WO 2019188607A1 JP 2019011538 W JP2019011538 W JP 2019011538W WO 2019188607 A1 WO2019188607 A1 WO 2019188607A1
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WO
WIPO (PCT)
Prior art keywords
catheter
hub
catheter assembly
connector
skin
Prior art date
Application number
PCT/JP2019/011538
Other languages
English (en)
Japanese (ja)
Inventor
山元翔太
木下秀明
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2020510752A priority Critical patent/JP7264875B2/ja
Publication of WO2019188607A1 publication Critical patent/WO2019188607A1/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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body

Definitions

  • the present invention relates to a catheter assembly and a catheter hub that are punctured and placed in a blood vessel, for example, when infusion is performed on a patient.
  • a catheter assembly used for infusion or the like to a patient is known.
  • This type of catheter assembly includes a hollow catheter, a catheter hub fixed to the proximal end of the catheter, a hollow inner needle that is inserted into the catheter and has a sharp needle tip, and a proximal end of the inner needle. And a needle hub secured to the.
  • This type of catheter and catheter hub is disclosed in, for example, Japanese Patent Laid-Open No. 8-103504.
  • the catheter When the catheter assembly is used, the catheter is advanced to the inner needle after the tip of the inner needle and the catheter is punctured into the skin and blood vessel of the living body, so that the catheter is inserted into the blood vessel for a predetermined length. . Thereafter, a connector connected to an infusion line (tube) is connected to the proximal end portion of the catheter hub.
  • the catheter hub is fixed to the patient's skin with medical tape or the like.
  • the present invention has been made in consideration of such problems, and a catheter assembly and a catheter hub that can reduce irritation to the skin and suppress discomfort to the patient when the catheter hub is fixed to the skin.
  • the purpose is to provide.
  • one aspect of the present invention provides a catheter assembly including a catheter, an inner needle removably inserted into the catheter, and a catheter hub provided at a proximal end of the catheter.
  • the catheter hub includes a hub main body provided with a connection portion connectable to a connector of a liquid feeding line, and an extension portion extending from the hub main body, and the extension portion is In a state where the catheter hub is fixed to the skin, the portion is in contact with the skin, and in a state where the connector is connected to the connection portion of the hub body, the connection portion and the extension portion are A catheter assembly into which a connector is inserted.
  • the tip edge of the connector does not directly contact the skin. For this reason, giving a patient discomfort can be suppressed.
  • the extension portion may extend in a direction inclined with respect to the axis of the hub body.
  • the extension portion may be elastically deformable in a direction approaching and separating from the hub body.
  • This configuration allows the extension part to be deformed according to the size of the connector, so that it can be used for connectors of various sizes.
  • the extension portion may extend from a position on the tip side with respect to the central portion in the length direction of the hub body.
  • This configuration makes it possible to make the extension part relatively long and to ensure an appropriate amount of elastic deformation.
  • At least a portion that can contact the outer peripheral portion of the connector may be made of a hard material.
  • This configuration can effectively suppress the load (load transmission) from the connector to the skin.
  • a concave curved portion may be provided on the upper surface of the extending portion.
  • the extension part may be a plate-like body.
  • the lower surface of the extending portion may be flat.
  • This configuration can reduce the contact pressure between the skin and the extension, and further suppress discomfort to the patient due to contact.
  • the width of the extension part may be larger than the width of the hub body.
  • This configuration can improve the stability when the catheter hub is fixed to the skin.
  • the extending portion may have a shape whose width increases toward the proximal direction.
  • This configuration can contribute to the compactness of the catheter hub since the width is relatively narrow on the distal end side of the extending portion. On the other hand, since the base end side of the extending portion is relatively wide, stability when the catheter hub is fixed to the skin can be improved.
  • the bottom surface of the base end of the extending portion may be curved so as to approach the axis of the hub body toward the base end.
  • This configuration can reduce the load on the skin at the base end of the extension.
  • Another aspect of the present invention is a catheter hub provided at a proximal end of a catheter, the hub body having a connection portion connectable to a connector of a liquid feeding line, and an extending portion extending from the hub body
  • the extension portion is a portion that contacts the skin when the catheter hub is fixed to the skin, and the connector is connected to the connection portion of the hub body, A catheter hub in which the connector is inserted between a connection portion and the extension portion.
  • the catheter assembly and catheter hub of the present invention it is possible to reduce irritation to the skin while the catheter hub is fixed to the skin, and to suppress discomfort to the patient.
  • FIG. 1 is a perspective view of a catheter assembly according to an embodiment of the present invention. It is a side view of the catheter hub of a catheter assembly. It is a top view of a catheter hub. It is operation
  • FIG. 6 is a sectional view taken along line VI-VI in FIG. 5.
  • the catheter assembly 10 shown in the initial state in FIG. 1 is used when infusion or blood transfusion is performed on a patient (living body).
  • the catheter assembly 10 can be configured as a peripheral venous catheter.
  • the catheter assembly 10 may be configured as a catheter (eg, central venous catheter, PICC, midline catheter, etc.) that is longer than the peripheral venous catheter.
  • the catheter assembly 10 is not limited to a venous catheter, and may be configured as an arterial catheter such as a peripheral artery catheter.
  • the catheter assembly 10 includes a catheter 12, a catheter hub 14 connected to the proximal end side of the catheter 12, an inner needle 16 that is removably inserted into the catheter 12, and a needle hub 18 connected to the inner needle 16. Is provided.
  • the catheter assembly 10 forms a double needle structure in which the catheter 12 and the inner needle 16 are overlapped in the radial direction in an initial state before use.
  • the catheter 12 is a flexible medical thin tube. A lumen is formed through the catheter 12.
  • the length of the catheter 12 is not particularly limited, and can be appropriately designed according to the application and various conditions.
  • a resin material in particular, a soft resin material is suitable.
  • soft resin materials include polyurethane (PU), polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorine-based resins such as perfluoroalkoxy fluororesin (PFA), and olefins such as polyethylene. Based resins.
  • the proximal end portion of the catheter 12 is fixed to the distal end portion in the catheter hub 14.
  • the catheter hub 14 is exposed on the patient's skin S (see FIG. 4) in a state where the catheter 12 is inserted into the blood vessel, is affixed with a tape or the like, and is placed with the catheter 12.
  • the catheter hub 14 has a hollow cylindrical hub body 20 and an extending portion 24 extending from the hub body 20 in the proximal direction.
  • the proximal end portion of the catheter 12 is fixed to the distal end portion of the hub body 20.
  • Inside the hub body 20 there is provided a hollow portion 21 that communicates with the lumen of the catheter 12 and can circulate liquid.
  • the hollow portion 21 has a hemostasis valve (not shown) that prevents backflow of blood when the inner needle 16 is punctured and enables infusion with the insertion of the connector 30 (see FIG. 4) of the infusion tube (liquid feeding line).
  • a plug or the like may be accommodated.
  • connection part 26 that can be connected to a cylindrical connector 30 (see FIG. 4) having a female screw formed on the inner peripheral surface is provided at the proximal end portion of the hub body 20.
  • the connection part 26 includes a connection cylinder part 26a and a pair of connection protrusions 26b protruding radially outward from the base end of the connection cylinder part 26a.
  • the pair of connection protrusions 26 b are portions that function as male screws that are screwed into the female screws of the connector 30.
  • a protrusion-like tab for allowing the user to operate the catheter hub 14 in the axial direction may be provided on the outer peripheral portion of the hub body 20.
  • the extension part 24 is a part that contacts the skin S in a state where the catheter hub 14 is fixed to the skin S, and functions as a skin protector that prevents the tip edge 30b of the connector 30 from directly contacting the skin S. Is.
  • the extending portion 24 extends (protrudes) from the lower portion of the hub body 20 in the proximal direction.
  • the extending portion 24 extends in a direction inclined with respect to the axis a of the hub body 20. Specifically, the extending portion 24 is inclined in a direction away from the axis a of the hub body 20 in the proximal direction.
  • a gap G is formed between the extension part 24 and the connection part 26 of the hub body 20.
  • the extending portion 24 faces the connecting portion 26 below the connecting portion 26 of the hub body 20. In a state where the connector 30 is connected to the connection portion 26 of the hub body 20, the connector 30 is inserted between the connection portion 26 and the extension portion 24 (the gap G) (see FIG. 4).
  • the extending portion 24 extends from a position on the tip side of the central portion in the length direction of the hub body 20.
  • the lower surface 24a of the extension part 24 is flat.
  • the base end portion lower surface 24b of the extending portion 24 is curved so as to approach the axis a of the hub body 20 toward the base end direction.
  • a portion of the extending portion 24 on the distal end side with respect to the proximal end portion is configured in a substantially linear shape in a side view.
  • the lower surface 24a of the extending part 24 is made of a soft material.
  • the soft material constituting the extending portion 24 include vinyl chloride, silicone rubber (thermosetting elastomer), olefin thermoplastic elastomer, polybutadiene thermoplastic elastomer, isoprene thermoplastic elastomer, and the like.
  • the extending part 24 is a plate-like body.
  • the extending portion 24 is generally flat.
  • the extending portion 24 can be elastically deformed in the direction of approaching and separating from the hub body 20. That is, the extension part 24 has a spring property.
  • the extending portion 24 has an appropriate thickness. Accordingly, the extending portion 24 is not film-like and has a rigidity that does not bend at least by its own weight.
  • the extending portion 24 is integrally formed with the hub body 20.
  • the extension part 24 may be a separate part fixed to the hub body 20.
  • the catheter hub 14 may be provided with a pair of wings that protrude from the hub body 20 to the left and right sides. In this case, the pair of wings may protrude left and right from the base portion of the extending portion 24 (the connection portion between the extending portion 24 and the hub body 20).
  • the width W2 (maximum width) of the extending portion 24 is larger than the width W1 (maximum width) that is the outer diameter of the hub body 20.
  • both end portions of the extending portion 24 protrude outward from the hub body 20.
  • the extension part 24 has a shape whose width increases toward the proximal direction. Therefore, the extending portion 24 is relatively narrow on the distal end side of the extending portion 24 and relatively wide on the proximal end side of the extending portion 24.
  • the edge portions 24e constituting both ends of the extending portion 24 in the width direction are inclined with respect to the axis a of the hub main body 20 in a direction away from the axis a of the hub main body 20 toward the proximal end direction. Yes.
  • the catheter hub 14 is made of, for example, a hard material such as a hard resin.
  • the constituent material of the catheter hub 14 is not particularly limited.
  • a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer may be applied.
  • the catheter hub 14 may be made of a soft material.
  • the extending portion 24 may be at least partially made of a soft material such as a soft resin.
  • a soft material such as a soft resin.
  • at least a portion of the extending portion 24 that can contact the outer peripheral portion of the connector 30 is made of a hard material.
  • the extension part 24 is integrally formed with the hub body 20 by a hard material.
  • the inner needle 16 is configured as a hollow tube having rigidity capable of puncturing the living body skin S, and is disposed through the lumen of the catheter 12 and the hollow portion 21 of the catheter hub 14.
  • the inner needle 16 is formed to have a full length longer than that of the catheter 12, and a sharp needle tip 16a is provided at the tip thereof.
  • the constituent material of the inner needle 16 include stainless steel, aluminum or aluminum alloy, metal material such as titanium or titanium alloy, hard resin, ceramics, and the like.
  • the needle hub 18 is fixed to the proximal end portion of the inner needle 16. In the initial state, the distal end portion of the needle hub 18 is inserted into the proximal end portion of the catheter hub 14 (specifically, the hub body 20). The needle hub 18 can be detached from the catheter hub 14 in the proximal direction.
  • the resin material which comprises the needle hub 18 is not specifically limited, For example, the material quoted by the catheter hub 14 can be selected suitably.
  • the user performs a puncturing operation for puncturing the catheter assembly 10 into the skin S of the patient.
  • the distal ends of the inner needle 16 and the catheter 12 are punctured into the skin S and the target blood vessel.
  • the user After puncturing, the user advances the catheter 12 while holding the catheter hub 14 while fixing the position of the needle hub 18. Thereby, the catheter 12 is inserted to the target position in the blood vessel. Next, the user pulls the needle hub 18 in the proximal direction while maintaining the position of the catheter 12. As a result, the inner needle 16 is removed from the catheter 12 and the catheter hub 14 in the proximal direction.
  • the user is provided at the end of the infusion tube on the proximal end side (the proximal end portion of the hub body 20) of the catheter 12 and the catheter hub 14 with the inner needle 16 removed.
  • Connected connector 30 is connected.
  • the lock cylinder 30a of the connector 30 is connected to the connection portion 26 of the hub body 20 by screwing.
  • the extension part 24 specifically, the lower surface 24a of the extension part 24
  • the extension part 24 (specifically, the lower surface 24a of the extension part 24) provided in the catheter hub 14 is in contact with the skin S. In this state, the lock cylinder 30 a of the connector 30 is inserted between the extension portion 24 and the hub body 20.
  • an infusion agent (medical solution) is administered from the infusion tube to the patient.
  • the catheter assembly 10 according to the present embodiment has the following effects.
  • the connector 30 when the catheter hub 14 and the connector 30 are connected, the connector 30 is inserted between the connecting portion 26 and the extending portion 24, so that the distal edge 30 b of the connector 30 is attached to the skin S. There is no direct contact. For this reason, irritation
  • the distal end edge 30b of the connector 30 comes into contact with the extending portion 24, so that the screwing of the connector 30 is not loosened.
  • the extending portion 24 extends in a direction inclined with respect to the axis a of the hub body 20. With this configuration, it is possible to form a gap G into which the connector 30 can be inserted between the extension portion 24 and the hub body 20 while forming the distal end side of the catheter hub 14 compactly.
  • the lower surface 24a of the extending portion 24 is made of a soft material, irritation due to the contact of the lower surface 24a of the extending portion 24 with the skin S can be reduced.
  • the extending portion 24 can be elastically deformed in a direction approaching and separating from the hub body 20. With this configuration, the extension portion 24 can be deformed according to the size of the connector 30, so that the connector 30 can be adapted to various sizes.
  • the extending portion 24 extends from a position on the tip side of the central portion in the length direction of the hub body 20. With this configuration, the extending portion 24 can be made relatively long, and an appropriate amount of elastic deformation can be ensured.
  • part which can contact at least the outer peripheral part of the connector 30 among the extension parts 24 is comprised by the hard material, the load (load transmission) from the connector 30 to the skin S can be suppressed effectively. .
  • the extending part 24 is a plate-like body. With this configuration, since the extending portion 24 has a certain thickness, the load on the skin S can be further reduced.
  • the contact pressure between the skin S and the extending part 24 can be reduced, and discomfort to the patient associated with the contact can be further suppressed.
  • the load on the skin S at the base end portion of the extending portion 24 is reduced. can do.
  • the width W2 of the extending portion 24 is larger than the width W1 of the hub body 20, the stability when the catheter hub 14 is fixed to the skin S can be improved.
  • the extending portion 24 has a shape that becomes wider in the proximal direction. With this configuration, the distal end side of the extension portion 24 has a relatively narrow width, which can contribute to the compactness of the catheter hub 14. On the other hand, since the base end side of the extending portion 24 is relatively wide, stability when the catheter hub 14 is fixed to the skin S can be improved.
  • a concave curved portion 34 is provided on the upper surface 24u of the extending portion 24A.
  • the concave curved portion 34 faces the connecting cylinder portion 26a of the hub main body 20, and extends with a certain length along the longitudinal direction of the extending portion 24A.
  • the concave curved portion 34 is an arcuate curved surface. According to the catheter hub 14A configured in this manner, stress concentration due to the connector 30 can be suppressed, and the load on the skin S from the connector 30 can be more effectively suppressed.

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

Abstract

L'invention concerne un ensemble cathéter (10), qui comprend un cathéter (12), une aiguille interne (16), et une embase de cathéter (14). L'embase de cathéter (14) comprend : un corps d'embase (20) qui comporte une partie de liaison (26) qui peut être reliée à un élément de liaison (30) ; et une partie étendue (24) qui s'étend depuis le corps d'embase (20). La partie étendue (24) est une partie qui entre en contact avec la peau (S), l'embase de cathéter (14) étant fixée à la peau (S). L'élément de liaison (30) est inséré entre la partie de liaison (26) et la partie étendue (24), l'élément de liaison (30) étant relié à la partie de liaison (26) du corps d'embase (20).
PCT/JP2019/011538 2018-03-28 2019-03-19 Ensemble cathéter et embase de cathéter WO2019188607A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2020510752A JP7264875B2 (ja) 2018-03-28 2019-03-19 カテーテル組立体及びカテーテルハブ

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018-062521 2018-03-28
JP2018062521 2018-03-28

Publications (1)

Publication Number Publication Date
WO2019188607A1 true WO2019188607A1 (fr) 2019-10-03

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ID=68060566

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PCT/JP2019/011538 WO2019188607A1 (fr) 2018-03-28 2019-03-19 Ensemble cathéter et embase de cathéter

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JP (1) JP7264875B2 (fr)
WO (1) WO2019188607A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08103504A (ja) * 1994-09-16 1996-04-23 Becton Dickinson & Co 医療器具用ネジ付コネクタ
DE19546809A1 (de) * 1995-12-14 1997-07-03 Willing Erika Venenverweilkanüle
US20040044314A1 (en) * 2002-08-27 2004-03-04 Jan Liska Transcutan catheter assembly

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08103504A (ja) * 1994-09-16 1996-04-23 Becton Dickinson & Co 医療器具用ネジ付コネクタ
DE19546809A1 (de) * 1995-12-14 1997-07-03 Willing Erika Venenverweilkanüle
US20040044314A1 (en) * 2002-08-27 2004-03-04 Jan Liska Transcutan catheter assembly

Also Published As

Publication number Publication date
JP7264875B2 (ja) 2023-04-25
JPWO2019188607A1 (ja) 2021-03-18

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