WO2005120621A1 - Intravascular indwelling catheter - Google Patents

Intravascular indwelling catheter Download PDF

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Publication number
WO2005120621A1
WO2005120621A1 PCT/JP2005/010747 JP2005010747W WO2005120621A1 WO 2005120621 A1 WO2005120621 A1 WO 2005120621A1 JP 2005010747 W JP2005010747 W JP 2005010747W WO 2005120621 A1 WO2005120621 A1 WO 2005120621A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
attachment
lumen
indwelling
connector
Prior art date
Application number
PCT/JP2005/010747
Other languages
French (fr)
Japanese (ja)
Inventor
Hiroshi Shibahara
Osamu Isogai
Hiroyuki Kojima
Norio Koike
Original Assignee
Unitika 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 Unitika Ltd. filed Critical Unitika Ltd.
Publication of WO2005120621A1 publication Critical patent/WO2005120621A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0034Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes

Definitions

  • the present invention relates to an intravascular indwelling catheter. More specifically, various medical treatments such as blood purification, infusion and administration of drug solution, blood collection, measurement of pulse pressure and blood flow, electrophysiological examination or temporary and short-term extracorporeal cardiac pacing, etc.
  • the present invention relates to an intravascular indwelling catheter used for diagnosis and treatment. book
  • Non-Patent Document 1 Conventionally, central venous indwelling catheters have been used for patients who need to administer infusions and drug solutions (see Non-Patent Document 1).
  • blood purification is necessary for diseases such as renal failure, diabetes, drug poisoning, systemic inflammatory response syndrome (SIRS), acute respiratory distress syndrome (ARDS), multiple organ failure (M0F), hepatitis, and knee inflammation
  • SIRS systemic inflammatory response syndrome
  • ARDS acute respiratory distress syndrome
  • M0F multiple organ failure
  • hepatitis hepatitis
  • knee inflammation a blood access force table that uses a catheter placed in a blood vessel to remove blood is used (see Non-Patent Document 2).
  • Non-Patent Document 3 a pulse pressure measurement catheter that is placed in the blood vessel and measures venous pressure, and a thermodie that measures blood flow such as cardiac output Reuse catheters are used (see Non-Patent Document 3).
  • cardiac output Reuse catheters There are also short-term pacing catheters used as short-term extracorporeal electrodes for cardiac pacemakers.
  • the above-mentioned catheters usually have a structure in which the lumen of one catheter is divided into a single layer or multiple layers according to the purpose. It has a structure in which electrical signals flow as sensors for measuring blood flow.
  • FIGS. 5A and 5B show a blood access catheter used in hemodialysis and the like as a related technique of the present invention, wherein a coaxial catheter in which a detachable inner catheter is inserted into a lumen of an outer catheter.
  • a coaxial catheter in which a detachable inner catheter is inserted into a lumen of an outer catheter.
  • blood is removed using an outer catheter, and blood is sent using an inner catheter, and an obturator (internal plug) is inserted when not in use.
  • an obturator internal plug
  • Non-patent document 1 Edited by the Japan Society for Parenteral and Enteral Nutrition: Guidelines for Co-medical Intravenous and Enteral Nutrition, 43, Nankodo (2000)
  • Non-patent Document 2 Yuhei Hirasawa: Dialysis Therapy Manual (Revised 5th Edition), 170, Japan Medical Center (1999)
  • Non-patent document 3 Sanae Tsuruta, Kazuko Harada: Postoperative treatment manual, 66, Shorinsha (1991)
  • Non-patent document 4 Shigeru Takagata, Ryuji Hongo, Akira Matsuzaki, Ryuzo Kato, Koetsu Kobayashi, Tadashi Harada , Masayoshi Tsuchida: Invention of Double Noremen Type UK Catheter, Journal of the Japan Dialysis Medical Association 5 (4), 220 (199 0)
  • the above-mentioned single-layer catheter with a single-lumen catheter is made for single-use purposes, and the catheter needs to be placed or replaced according to the purpose.As a result, frequent punctures to the patient are indispensable It was. In addition, even when a single catheter having a lumen divided into multiple layers is used for a plurality of purposes, the lumen is blocked by blood or a drug solution, or sticks to a blood vessel wall when blood is sucked from a side hole of the catheter.
  • the indwelling catheter is
  • the inner catheter comprises two or more single-lumen catheters or one or more multi-lumen catheters. Further, in one or more embodiments of the present invention, two or more single-layer lumen catheters or multiple-layer lumen catheters constituting the inner catheter are separately detachable.
  • the catheter for indwelling in a blood vessel may be provided with a therapeutic or diagnostic sensor through a lumen of an inner catheter, and may also have a therapeutic or diagnostic sensor function. It is a catheter for indwelling in a blood vessel. Further, in one or more embodiments of the present invention, the intravascular indwelling catheter may further include a cardiac pacemaker electrode mounted through a lumen of the inner catheter. It is a utility Tetenore.
  • the intravascular indwelling catheter includes a connector part provided on the outer catheter, a plurality of connection parts provided integrally with the connector and provided on an upper part of the connector part, A screw provided at each connection portion; and an ack ring provided at each of the inner catheters and fastened with the screw.
  • the intravascular indwelling catheter includes a connector part provided on the outer catheter, an attachment screwed to the connector part, and a plurality of parts integrally provided with the attachment. And a connection part.
  • Each of the inner catheters is connected to the outer catheter via a connection.
  • an intravascular indwelling catheter includes: a connector part provided on an outer catheter; and a Y tube part provided on an inner catheter and screwed to the connector part. .
  • the intravascular indwelling catheter includes an attachment for connecting the outer catheter and the inner catheter.
  • the attachment has a screw structure whose length can be adjusted.
  • an intravascular indwelling catheter includes an bellows-type attachment that connects an outer catheter and an inner catheter and has an adjustable length.
  • the indwelling catheter is
  • a plurality of detachable attachments for connecting the outer catheter and the inner catheter By changing the number of detachable attachments, the length of the entire attachment is adjusted.
  • one inner catheter indwelled in a blood vessel can be selectively mounted with an inner catheter having a shape and a number suitable for various purposes, and can be occluded.
  • an inner catheter having a shape and a number suitable for various purposes, and can be occluded.
  • an obturator inner plug
  • a device having a means for removing or collecting a thrombus formed on the outer periphery or the lumen of the catheter during placement can be introduced, so that the catheter can be placed for a long time.
  • FIG. 1A is a schematic diagram showing an example of connecting an inner catheter composed of two single-layer lumen catheters to an arter catheter in one or more embodiments of the present invention.
  • FIG. 1B is a cross-sectional view taken along the line IB-IB of FIG. 1A.
  • FIG. 2A is a schematic diagram illustrating an example of a cross-sectional view illustrating an inner surface of a connector portion of an outer force tail according to one or more embodiments of the present invention.
  • FIG. 2B is a sectional view taken along the line ⁇ B- ⁇ B in FIG. 1A.
  • FIG. 3A is a schematic diagram illustrating an example of mounting two inner catheters on an outer force table in one or more embodiments of the present invention.
  • Fig. 3B is a cross-sectional view of Fig. 3A.
  • FIG. 4A is a lateral view showing an example of a partial shape of a connector for mounting three inner catheters in an outer catheter according to one or more embodiments of the present invention.
  • FIG. 4B is a top view showing an example of a partial shape of a connector for mounting three inner catheters in the outer catheter of one or more embodiments of the present invention.
  • FIG. 5A is a schematic view of the shape of a coaxial blood access catheter according to the related art of the present invention.
  • Figure 5B is a cross-sectional view of VB -VB in Figure 5A.
  • FIG. 6A is a cross-sectional view illustrating an example of a partial structure of an adapter of an inner force table according to one or more embodiments of the present invention.
  • FIG. 6B is a perspective view of a lateral surface showing an example of a partial structure of the adapter of the inner force table according to one or more embodiments of the present invention.
  • FIG.7A is a schematic diagram showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting two inner force catheters in one or more embodiments of the present invention.
  • FIG. 5 is a view from the side of an attachment for attaching the inner catheter of FIG.
  • FIG. 7B illustrates two inner contacts in one or more embodiments of the invention.
  • FIG. 4 is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for attaching a catheter, as viewed from above an attachment for attaching two inner catheters.
  • FIG.8A is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting three inner force catheters according to one or more embodiments of the present invention.
  • FIG. 5 is a view from the side of an attachment for attaching the inner catheter of FIG.
  • FIG.8B is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting three inner force catheters according to one or more embodiments of the present invention.
  • FIG. 2 is a view from above of an attachment for mounting the inner catheter.
  • FIG. 9A is a schematic view showing an example of an attachment to be fitted to a part of a connector of an outer catheter for mounting a double-lumen inner catheter in one or more embodiments of the present invention.
  • FIG.9B is a schematic diagram showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting a double-lumen inner catheter according to one or more embodiments of the present invention.
  • FIG. 1 OA is a schematic diagram showing an example of the structure of a screw-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention.
  • the schematic diagram which shows the whole shape which mounted
  • FIG. 10B is a schematic view showing an example of the structure of a screw-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
  • FIG. 11A illustrates a bellows-type device that can finely adjust the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. It is the schematic which shows an example of the structure of a tument, The schematic which shows the whole shape which mounted the outer catheter and the inner force catheter.
  • FIG. 11B is a schematic view showing an example of the structure of a bellows-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
  • FIG.12A is a schematic diagram showing an example of the structure of a combination type attachment that can finely adjust the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention.
  • FIG. 2 is a schematic diagram showing an overall shape in which an outer catheter and an inner catheter are mounted.
  • FIG.12B is a schematic view showing an example of the structure of a combination type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
  • FIG. 13A is a schematic diagram showing an example of the structure of a fixed fastening attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention.
  • FIG. 1 is a schematic view showing the overall shape of an outer catheter and an inner catheter.
  • FIG.13B is a schematic view showing an example of a structure of a fixed fastening attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention.
  • FIG. 2 is a schematic view showing the structure of an attachment.
  • FIG.13C is a schematic view showing an example of a structure of a fixed fastening attachment that can finely adjust the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention.
  • FIG. 13D shows a tightening fastener that can fine-tune the length of the inner catheter attached to the outer catheter in one or more embodiments of the present invention.
  • FIG. 3 is a schematic view showing an example of the structure of a fixed attachment, and is a schematic view showing the structure of a lumen of the attachment.
  • FIG. 14 illustrates an example of an obturator (inner plug) attached to an outer catheter to prevent thrombus formation in a lumen when the inner power tail is not used in one or more embodiments of the present invention. It is a schematic diagram.
  • FIG. 15 is a schematic diagram illustrating an example of the shape of a device for physically removing a thrombus formed in a lumen of an outer force tail according to one or more embodiments of the present invention.
  • FIG. 16 is a schematic diagram of a catheter with a cuff attached to an outer catheter for intimate contact with subcutaneous tissue in one or more embodiments of the present invention.
  • FIG. 17 is a schematic diagram showing an example of an outer catheter in which a side injection portion can be removed and replaced in one or more embodiments of the present invention.
  • an inner catheter composed of two or more single-layer lumen catheters or one or more multi-layer lumen catheters is removably fitted to the outer catheter.
  • outer catheter used in the present invention or one or more embodiments what is known as an outer catheter in a conventional coaxial catheter can be similarly used.
  • Fig. 1A shows the vascular indwelling catheter detachably fitted by the method a) above.
  • FIG. 1A shows a state in which a part of the adapter of the inner catheter is detached from a part of the connector of the outer catheter for convenience of explanation of the fitting method.
  • the inner catheter 2 penetrates and is fixed to the adapter part 23, and the lower part of the adapter part 23 has a male luer taper 25 (see FIGS. 6A and 6B).
  • the inner lumen has a luer taper structure 26 as shown in Fig. 2A so that the connector part 11 of the outer catheter 1 can be fitted and connected to the adapter part 23 to which the inner catheter 2 is fixed. .
  • a screw portion 19 is formed at the upper connection portion 20 of the connector portion 1 1 of the outer catheter 1, and the adapter ring 23 is attached to and detached from the connector portion 11 by being screwed with the lock ring portion 24. Can be fitted as much as possible.
  • the outer catheter In a catheter for indwelling a blood vessel, the outer catheter has a side injection portion 14 that can be used as a lumen for blood removal or blood transmission, and a thread hook portion 13 for fixing the catheter to the skin with a suture. ing.
  • a hub 15 for connecting to a line such as an extracorporeal circulation circuit, a syringe, or the like is provided on a tube connected to the proximal side tube of the inner power catheter 2 and the side injection section 14 of the outer catheter 1.
  • a clamp 16 to temporarily block the lumen.
  • the outer catheter can be used repeatedly for a long period of time. It is also possible to adopt a structure in which 15 parts can be removed and replaced.
  • the outer catheter 1 is composed of a thread hook portion 13, a clamp tube portion 12, and a connector part 11.
  • the number, length, and number of lumens of the inner catheter are selected according to the purpose. For example, when used as a catheter for central parenteral nutrition, the infusion is administered to an inner catheter. On the other hand, when used for extracorporeal circulation such as blood purification, as shown in Fig. 1A and Fig. 1B, two inner catheters (21 and 22) with different lengths for blood removal are used. Can be connected to circulate blood.
  • the inner catheter 2 has pulse pressure and blood flow through its lumen.
  • Various sensors for the amount and the like and electrodes for cardiac pacing may be mounted.
  • Such an intravascular indwelling catheter can also be used for therapeutic use and diagnostic use.
  • the sensor include a metal wire sensor embedded in a lumen of a catheter and sensing an electric signal or the like.
  • thermodilution catheter when measuring the blood flow, the temperature dilution of the blood when the ice-cold physiological saline is poured from the proximal side of the catheter and the temperature is measured by the sensor at the tip side Measured by As for pressure measurement, there is a method in which air is injected into a balloon provided at the tip of the catheter, and the pressure applied to the balloon is measured by a pressure sensor at hand.
  • Electrodes for cardiac pacing are provided at two points on the distal end of the catheter and on the proximal side.
  • the electrodes are connected to an external pacemaker generator outside the body to perform pacing.
  • the shape of the clamp 16 use a pinch type that closes the tube by pressing it with a finger, or a slit type that closes the tube by sliding a slit into a plate-shaped object with a gradually decreasing width.
  • the shape is not particularly limited as long as it has a function of closing the tube.
  • a check valve structure 18 that minimizes the leakage of blood outside the body when the inner catheter 2 or the obturator 13 is attached.
  • the structure of the check valve may be, for example, a layer with a thickness of elastic rubber containing a slit, but the material and structure are not particularly limited as long as the structure does not leak liquid such as blood. Not something.
  • the catheter may be made of any material that is safe and elastic when placed in the body, especially in blood vessels.
  • examples include polyurethane, silicone, polyvinyl chloride, polybutadiene, polyamide, and ethylene-vinyl acetate copolymer.
  • polyurethane which has the property of maintaining hardness outside the body and being flexible inside the body, is preferred.
  • the outer catheter 1 is in close contact with the subcutaneous tissue 8 as shown in Fig. 16.
  • the cuff 52 having the function of causing the cuff 52 to be attached may be attached at one or more of the force table portions between the skin 7 penetration portion and the blood vessel 9 penetration portion.
  • the shape of the cuff includes a cotton-like fiber, a sponge-like one, a part of a force table with a raised portion, and the like.
  • the material is a synthetic polymer such as polyester, nylon, and acrylic. Compounds or natural polymer compounds such as cotton, silk, chitin and the like.
  • connection part 20 is formed on the upper part of the connector part 11 of the outer catheter 1 so as to correspond to each one of the inner force catheters 2 and is integrated with the connector part 11.
  • a screw 19 is formed at the mouth of the connection part 20 so that the lock ring 24 is screwed.
  • connection portion in b) is directly screwed to the connector portion 11 of the outer catheter via an attachment.
  • FIGS.7A to 8B show the case where two inner catheters are used in FIGS.7A and 7B, and the case where three inner catheters are used in FIGS.8A and 8B. Is shown.
  • the connection part 20 formed corresponding to each inner power catheter 2 is integrated with the attachment.
  • the inner lumen of this attachment is threaded, and a part of the connector of the outer catheter is provided. Screwed to the mouth.
  • an elastic rubber attachment having a tapered inner hole into which the Y-tube portion of the inner catheter can be inserted is partially connected to the connector of the outer catheter. Then, the inner catheter is pushed into the inner hole by a screw. Specifically, this is shown in FIGS. 9A and 9B.
  • Attachment 6 having a structure substantially matching the shape of Y-tube portion 51 of double lumen catheter 5 disclosed in FIG. 9A can be connected to connector portion 11 of the outer catheter.
  • catheters having various shapes can be formed according to the present invention.
  • One catheter 1 can be connected.
  • an attachment for connecting the outer catheter 1 and the inner catheter 2 a structure in which the length of the inner catheter can be finely adjusted while connected to the outer catheter 1 can be employed.
  • FIGS. 1OA and 10B show the attachment body as a threaded structure 53, and the lock ring 24 fitted thereto is rotated to fit the outer catheter 1. Are shown to adjust In addition, there is a method of rotating the lock ring portion 24 of the adapter portion 23 of the inner catheter 2 to adjust the length of the attachment.
  • Fine adjustment of the length of the inner catheter is performed for the purpose of changing the tip of the catheter to a position where it does not contact the blood vessel wall, etc., but the length of the fine adjustment is preferably within 5 cm, More preferably, the function is performed in the range of cm.
  • Other methods for fine-tuning the length of the inner catheter include bellows-type attachments 54 as shown in FIGS. 11A and 11B, as well as those shown in FIGS. 12A and 12B. It may be a combination of multiple detachable attachments 55, and adjust the length while tightening the lock ring as shown in Figs.13A to 13D. Attachment 5 6 to fix and fix. The range of the fine adjustment of the length is as described above.
  • the structure of the attachment may be integrated with the connector portion of the outer catheter 1.
  • an obturator inner plug as shown in Fig. Can also be attached.
  • the structure of the obturator 3 only needs to have the structure of a rod-shaped obturator main body 31 having a thickness to close the inner lumen of the outer catheter and an adapter 23 to be attached to the outer catheter 1.
  • the structure of the adapter 23 may be basically the same as that of the inner catheter 2.
  • An example of the structure of a device for removing or collecting a thrombus is a loop-shaped wire portion 41 for grasping an object such as a thrombus, but the shape of the wire portion 41 is to remove or collect a thrombus.
  • the shape of the wire portion 41 is to remove or collect a thrombus.
  • the structure of the adapter part 23 may be basically the same as that of the inner catheter 2.
  • the structure of the device 4 for removing or collecting thrombus may be a method of removing or collecting thrombus by suction force, instead of the wire shape.
  • the intravascular indwelling catheter of the present invention may be subjected to an antithrombotic treatment in order to prevent formation of a thrombus due to contact with blood during indwelling.
  • plasminogen activator such as perokinase
  • a chemical bonding method for details, see Patent No. 1406803.
  • Various methods have been developed, such as a method of coating a catheter surface with an anticoagulant factor such as palin, but the method is not limited to a specific method.
  • the range of the antithrombotic treatment may be the outer surface, the inner surface, or both of the catheter as long as the portion comes into contact with blood.
  • the catheter for indwelling in the blood vessel according to the present invention includes an antibacterial agent, an antibiotic, or the like on the entire or part of the surface of the force sensor of the base material to prevent infection with bacteria, fungi, viruses, and the like during the indwelling of the catheter.
  • an antibacterial agent for example, JP-A-2001-276210
  • those in which an antibacterial agent is directly kneaded into a substrate for example, see JP-A-8-157). 641).
  • the catheter for indwelling in a blood vessel of the present invention has been subjected to a lubricating treatment such as coating the surface of a base material with a hydrophilic polymer compound in order to facilitate penetration into a subcutaneous tissue or a blood vessel (for example, And Japanese Patent Application Laid-Open No. 10-248919.
  • a lubricating treatment such as coating the surface of a base material with a hydrophilic polymer compound in order to facilitate penetration into a subcutaneous tissue or a blood vessel (for example, And Japanese Patent Application Laid-Open No. 10-248919.
  • Many methods have been developed for lubricating treatment, but any method may be selected.
  • the range of the lubricating treatment may be any part as long as it is a part that comes into contact with the human body or a part that comes into contact with a tool for placing the force catheter.
  • One or more embodiments of the present invention can selectively mount one inner catheter indwelled in a blood vessel to a catheter and a shape suitable for various purposes and a number of inner catheters.
  • a new inner catheter with a different length or thickness can be easily replaced as many times as necessary, and as a result, a catheter for indwelling indwelling that can be indwelled continuously for a long period of time is provided. I do.
  • catheters can be used continuously until the end of the purpose, unless there is a problem with the catheter itself, such as for central parenteral nutrition, which is used over a long period of one month or one year Useful for various purposes.

Abstract

An intravascular indwelling catheter, wherein an outer catheter (1) and inner catheters (21, 22) detachably fitted to the outer catheter (1) in the lumen of the outer catheter (1). The inner catheters are formed of two or more single layer lumen catheters (21, 22) or one or more multi-layer lumen catheters.

Description

血管内留置用カテーテル 技術分野 Technical Field of Intravascular Catheter
本発明は、 血管内留置用カテーテルに関する。 さらに詳しくは、 血液浄 化、 輸液 ·薬液の投与、 採血、 脈圧 ·血流量の測定、 電気生理学的検査または一 時的、 短期的な体外式心臓ぺーシン明グ等、 様々な医療上の診断や治療の目的で使 用される血管内留置用カテーテルに関する。 書  The present invention relates to an intravascular indwelling catheter. More specifically, various medical treatments such as blood purification, infusion and administration of drug solution, blood collection, measurement of pulse pressure and blood flow, electrophysiological examination or temporary and short-term extracorporeal cardiac pacing, etc. The present invention relates to an intravascular indwelling catheter used for diagnosis and treatment. book
背景技術 Background art
従来、 輸液 ·薬液の投与を必要とする患者に対しては、 中心静脈留置用 カテーテルが使用されている (非特許文献 1参照) 。 また、 腎不全、 糖尿病、 薬 物中毒、 全身性炎症反応症候群 (SIRS) 、 急性呼吸促拍症候群 (ARDS) 、 多臓器 不全 (M0F) 、 肝炎、 膝炎等の疾病のために血液浄化を必要とする患者に対して は、 血管内にカテーテルを留置して血液を脱送血するブラッドアクセス力テーテ ルが使用されている (非特許文献 2参照) 。 さらに、 中心静脈圧 ·血流量の測定 を必要とする患者に対しては、 血管内に留置し静脈圧を測定する脈圧測定用カテ 一テル、 心拍出量等血流量を測定するサーモダイリユーシヨンカテーテルが使用 されている (非特許文献 3参照) 。 また、 心臓ペースメーカーの短期的体外式電 極として使用する短期ぺーシング用カテーテルがある。  Conventionally, central venous indwelling catheters have been used for patients who need to administer infusions and drug solutions (see Non-Patent Document 1). In addition, blood purification is necessary for diseases such as renal failure, diabetes, drug poisoning, systemic inflammatory response syndrome (SIRS), acute respiratory distress syndrome (ARDS), multiple organ failure (M0F), hepatitis, and knee inflammation For patients with the above-mentioned, a blood access force table that uses a catheter placed in a blood vessel to remove blood is used (see Non-Patent Document 2). In addition, for patients who need to measure central venous pressure and blood flow, a pulse pressure measurement catheter that is placed in the blood vessel and measures venous pressure, and a thermodie that measures blood flow such as cardiac output Reuse catheters are used (see Non-Patent Document 3). There are also short-term pacing catheters used as short-term extracorporeal electrodes for cardiac pacemakers.
上記のカテーテルは通常、 目的に応じて 1本のカテーテルの内腔が単層あ るいは複数層に分かれた構造をしており、 それぞれの内腔に薬液や血液等が流れ る他、 脈圧や血流量を測定するセンサーとして電気的信号が流れる構造になって いる。  The above-mentioned catheters usually have a structure in which the lumen of one catheter is divided into a single layer or multiple layers according to the purpose. It has a structure in which electrical signals flow as sensors for measuring blood flow.
さらに、 図 5 Aおよび図 5 Bは、 本発明の関連技術として、 血液透析等 において使用されるブラッドアクセスカテーテルであって、 アウターカテーテル の内腔に着脱式のインナーカテーテルを挿入したコアクシャル型のカテーテルを 開示する。 このカテーテルは、 アウターカテーテルで脱血し、 インナ一力テーテ ルで送血し、 非使用時にォブチュレーター (内栓) が挿入される。 (非特許文献 4参照) 。 FIGS. 5A and 5B show a blood access catheter used in hemodialysis and the like as a related technique of the present invention, wherein a coaxial catheter in which a detachable inner catheter is inserted into a lumen of an outer catheter. To Disclose. In this catheter, blood is removed using an outer catheter, and blood is sent using an inner catheter, and an obturator (internal plug) is inserted when not in use. (See Non-Patent Document 4).
[非特許文献 1 ] Θ本静脈経腸栄養学会編集: コメディカルのための静脈 ·経腸 栄養ガイドライン, 43, 南江堂 (2000)  [Non-patent document 1] Edited by the Japan Society for Parenteral and Enteral Nutrition: Guidelines for Co-medical Intravenous and Enteral Nutrition, 43, Nankodo (2000)
[非特許文献 2 ] 平沢由平:透析療法マニュアル (改訂第 5版) , 170, 日本メ ディカルセンター(1999)  [Non-patent Document 2] Yuhei Hirasawa: Dialysis Therapy Manual (Revised 5th Edition), 170, Japan Medical Center (1999)
[非特許文献 3 ] 鶴田早苗, 原田和子:術後処理マニュアル, 66, 照林社(1991) [非特許文献 4 ] 宫形滋, 本郷隆二, 松崎章, 加藤隆三, 小林浩悦, 原田忠, 土 田正義:ダブルノレーメン型 UKカテーテルの考案, 日本透析医会雑誌5 (4),220 (199 0) [Non-patent document 3] Sanae Tsuruta, Kazuko Harada: Postoperative treatment manual, 66, Shorinsha (1991) [Non-patent document 4] Shigeru Takagata, Ryuji Hongo, Akira Matsuzaki, Ryuzo Kato, Koetsu Kobayashi, Tadashi Harada , Masayoshi Tsuchida: Invention of Double Noremen Type UK Catheter, Journal of the Japan Dialysis Medical Association 5 (4), 220 (199 0)
上記した 1本のカテーテルの内腔が単層のカテーテルは、 単独使用の目的 で作られ、 その目的に応じてカテーテルの留置または交換を必要とし、 結果的に 患者への頻回の穿刺が不可欠となっていた。 また、 複数の目的で内腔が複数層に 分かれた 1本のカテーテルを使用した場合でも、 内腔が血液や薬液で閉塞したり 、 カテーテルの側孔から血液を吸引する際に血管壁にへばりついて吸引できなく なるなど目的を果たせなくなるトラブルが発生した場合、 例えば目的とするルー メン以外の他のルーメンが使用できたとしても留置した力テーテノレ全体を交換す る必要があり、 医療従事者、 患者双方に肉体的、 精神的に多大な負担を強いるも のであるばかりでなく、 医療経済上も大きな損失を招くものであった。  The above-mentioned single-layer catheter with a single-lumen catheter is made for single-use purposes, and the catheter needs to be placed or replaced according to the purpose.As a result, frequent punctures to the patient are indispensable It was. In addition, even when a single catheter having a lumen divided into multiple layers is used for a plurality of purposes, the lumen is blocked by blood or a drug solution, or sticks to a blood vessel wall when blood is sucked from a side hole of the catheter. If a trouble occurs that cannot achieve its purpose, such as the inability to aspirate due to a problem, for example, even if other lumens than the intended lumen can be used, it is necessary to replace the entire indwelling force catheter, This not only puts a great physical and mental burden on both patients, but also causes a great loss in healthcare economy.
また、 このようなトラブルによる頻回のカテーテル交換は、 病原菌の侵 入に伴う感染の危険性や血管自体の閉塞の可能性が高まり、 全身性炎症反応症候 群、 急性呼吸促拍症候群、 多臓器不全、 白血病など元来免疫機能が低下して感染 リスクの高い患者や、 血管の脆弱な老人、 血管が細く未発達の乳幼児、 小児にと つては特に重大な問題となっていた。  Frequent catheter replacement due to such troubles increases the risk of infection due to the invasion of pathogens and the possibility of blockage of blood vessels themselves, systemic inflammatory reaction symptoms, acute respiratory distress syndrome, multiple organs This was a particularly serious problem for patients at high risk of infection due to reduced immune function such as insufficiency and leukemia, elderly people with fragile blood vessels, undeveloped infants and children with narrow blood vessels.
さらに上記したコアクシヤノレ型カテーテルについても先に示したカテー テルと同様、 閉塞によりインナ一カテーテルが使用できなくなったとしても、 交 換は可能であるが、 アウターカテーテルが閉塞または脱血不良となった際は、 ァ ウタ一カテーテル自体を抜去することすなわちカテーテル全体を交換することを 余儀なくされていた。 発明の開示 In addition, as with the above-mentioned catheter, even if the inner catheter becomes unusable due to occlusion, replacement is possible, but the outer catheter becomes occluded or has poor blood removal. Is It was necessary to remove the catheter itself, that is, to replace the entire catheter. Disclosure of the invention
本発明の一または一以上の実施例において、 血管内留置用カテーテルは In one or more embodiments of the present invention, the indwelling catheter is
、 アウターカテーテルと、 該アウターカテーテルのルーメン内に揷通され該ァゥ ターカテーテルと着脱可能に嵌合するインナーカテーテルとからなる。 該インナ 一カテーテルは、 2以上の単層ルーメンカテーテルまたは 1もしくは 2以上の複 層ルーメンカテーテルからなる。 また、 本発明の一または一以上の実施例におい て、 インナーカテーテルを構成する 2以上の単層ルーメンカテーテルまたは複層 ルーメンカテーテルは、 各々別個に着脱可能である。 An outer catheter; and an inner catheter which is inserted through the lumen of the outer catheter and is detachably fitted to the outer catheter. The inner catheter comprises two or more single-lumen catheters or one or more multi-lumen catheters. Further, in one or more embodiments of the present invention, two or more single-layer lumen catheters or multiple-layer lumen catheters constituting the inner catheter are separately detachable.
また、 本発明の一または一以上の実施例において、 血管内留置用カテー テルは、 インナーカテーテルのルーメンを通じて治療用又は診断用センサーが装 着されている、 治療用又は診断用センサー機能を併せ持つ前記の血管内留置用力 テーテルである。 さらに、 本発明の一または一以上の実施例において、 血管内留 置用カテーテルは、 インナーカテーテルのルーメンを通じて心臓ペースメーカー 用の電極が装着されている、 心臓べ一シング機能を併せ持つ前記の血管内留置用 力テーテノレである。  In one or more embodiments of the present invention, the catheter for indwelling in a blood vessel may be provided with a therapeutic or diagnostic sensor through a lumen of an inner catheter, and may also have a therapeutic or diagnostic sensor function. It is a catheter for indwelling in a blood vessel. Further, in one or more embodiments of the present invention, the intravascular indwelling catheter may further include a cardiac pacemaker electrode mounted through a lumen of the inner catheter. It is a utility Tetenore.
本発明の一または一以上の実施例において、 血管内留置用カテーテルは 、 アウターカテーテルに設けられたコネクタ一部と、 コネクターと一体化してコ ネクター部の上部に設けられた複数の接続部と、 それぞれの接続部に設けられた ネジと、 インナーカテーテルのそれぞれに設けられ前記ネジとネジ締めされる口 ックリングと、 を備える。  In one or more embodiments of the present invention, the intravascular indwelling catheter includes a connector part provided on the outer catheter, a plurality of connection parts provided integrally with the connector and provided on an upper part of the connector part, A screw provided at each connection portion; and an ack ring provided at each of the inner catheters and fastened with the screw.
本発明の一または一以上の実施例において、 血管内留置用カテーテルは 、 アウターカテーテルに設けられたコネクタ一部と、 コネクタ一部にネジ止めさ れるアタッチメントと、 アタッチメントと一体的に設けられた複数の接続部と、 を備える。 インナーカテーテルのそれぞれは、 接続部を介して、 アウターカテー テルと接続される。 本発明の一または一以上の実施例において、 血管内留置用カテーテルは 、 アウターカテーテルに設けられたコネクタ一部と、 インナーカテーテルに設け られコネクタ一部にネジ止めされる Y管部と、 を備える。 In one or more embodiments of the present invention, the intravascular indwelling catheter includes a connector part provided on the outer catheter, an attachment screwed to the connector part, and a plurality of parts integrally provided with the attachment. And a connection part. Each of the inner catheters is connected to the outer catheter via a connection. In one or more embodiments of the present invention, an intravascular indwelling catheter includes: a connector part provided on an outer catheter; and a Y tube part provided on an inner catheter and screwed to the connector part. .
本発明の一または一以上の実施例において、 血管内留置用カテーテルは 、 アウターカテーテルとインナーカテーテルとを接続するアタッチメントを備え る。 アタッチメントは、 長さを調節可能な、 ネジ構造を有する。  In one or more embodiments of the present invention, the intravascular indwelling catheter includes an attachment for connecting the outer catheter and the inner catheter. The attachment has a screw structure whose length can be adjusted.
本発明の一または一以上の実施例において、 血管内留置用カテーテルは 、 アウターカテーテルと、 インナーカテーテルとを接続し、 長さを調節可能な蛇 腹式アタッチメント、 を備える。  In one or more embodiments of the present invention, an intravascular indwelling catheter includes an bellows-type attachment that connects an outer catheter and an inner catheter and has an adjustable length.
本発明の一または一以上の実施例において、 血管内留置用カテーテルは In one or more embodiments of the present invention, the indwelling catheter is
、 アウターカテーテルと、 インナーカテーテルとを接続する、 複数の着脱式ァタ ツチメント、 を備える。着脱式ァタツチメントの装着個数を変更することにより 、 アタッチメント全体の長さが調整される。 A plurality of detachable attachments for connecting the outer catheter and the inner catheter. By changing the number of detachable attachments, the length of the entire attachment is adjusted.
その他の特徴および効果は、 実施例の記載および添付のクレームより明 白である。 本発明の一または複数の実施例によれば、 血管内に留置された 1本のァ ゥターカテーテルに様々な目的に適した形状及び本数のィンナーカテーテルの選 択的装着が可能で、 閉塞等のトラブルが生じた時には新たなインナーカテーテル を簡便に交換でき、 更に、 不要時にはォブチュレーター (内栓) を挿入し内腔全 体を内封することが可能となる。 また、 留置中にカテーテルの外周または内腔に 形成された血栓を除去または回収する手段を有するデバイスを揷入することもで きるため、 長期にわたるカテーテルの留置が可能である。  Other features and advantages are apparent from the description of the examples and the appended claims. According to one or more embodiments of the present invention, one inner catheter indwelled in a blood vessel can be selectively mounted with an inner catheter having a shape and a number suitable for various purposes, and can be occluded. When troubles such as occur, a new inner catheter can be easily replaced, and when unnecessary, an obturator (inner plug) can be inserted to seal the entire lumen. In addition, a device having a means for removing or collecting a thrombus formed on the outer periphery or the lumen of the catheter during placement can be introduced, so that the catheter can be placed for a long time.
また、 感染を防止するためィンナーカテーテルの定期的交換が簡便に行 える。 また、 アウターカテーテルにカフを設けたものは皮下組織と密着させるこ とができる。 図面の簡単な説明 図 1 Aは、 本発明の一または一以上の実施例のカテーテルにおけるァゥ ターカテーテルと 2本の単層ルーメンカテーテルからなるィンナーカテーテルを 接続する一例を示す概略図である。 In addition, regular replacement of the inner catheter can be easily performed to prevent infection. The outer catheter provided with a cuff can be in close contact with the subcutaneous tissue. Brief Description of Drawings FIG. 1A is a schematic diagram showing an example of connecting an inner catheter composed of two single-layer lumen catheters to an arter catheter in one or more embodiments of the present invention.
図 1 Bは、 図 1 Aの I B - I B断面図。  FIG. 1B is a cross-sectional view taken along the line IB-IB of FIG. 1A.
図 2 Aは、 本発明の一または一以上の実施例におけるアウター力テーテ ルのコネクター部内面を示す断面図の一例を示す概略図である。  FIG. 2A is a schematic diagram illustrating an example of a cross-sectional view illustrating an inner surface of a connector portion of an outer force tail according to one or more embodiments of the present invention.
図 2 Bは、 図 1 Aの Π B - Π B断面図。  FIG. 2B is a sectional view taken along the line ΠB-ΠB in FIG. 1A.
図 3 Aは、 本発明の一または一以上の実施例におけるアウター力テーテ ルにおける 2本のィンナーカテーテルを装着する一例を示す概略図である。  FIG. 3A is a schematic diagram illustrating an example of mounting two inner catheters on an outer force table in one or more embodiments of the present invention.
図 3 Bは、 図 3 Aの ΠΙ Β - ΠΙ Β断面図  Fig. 3B is a cross-sectional view of Fig. 3A.
図 4 Aは、 本発明の一または一以上の実施例のアウターカテーテルにお ける 3本のィンナーカテーテルを装着するためのコネクタ一部形状の一例を示す 横面図。  FIG. 4A is a lateral view showing an example of a partial shape of a connector for mounting three inner catheters in an outer catheter according to one or more embodiments of the present invention.
図 4 Bは、 本発明の一または一以上の実施例のアウターカテーテルにお ける 3本のインナーカテーテルを装着するためのコネクタ一部形状の一例を示す 上面図。  FIG. 4B is a top view showing an example of a partial shape of a connector for mounting three inner catheters in the outer catheter of one or more embodiments of the present invention.
図 5 Aは、 本発明の関連技術にかかるコアクシャル型ブラッドアクセス カテーテルの形状の概略図である。  FIG. 5A is a schematic view of the shape of a coaxial blood access catheter according to the related art of the present invention.
図 5 Bは、 図 5 Aの V B -V B断面図  Figure 5B is a cross-sectional view of VB -VB in Figure 5A.
図 6 Aは、 本発明の一または一以上の実施例におけるインナ一力テーテ ルのアダプタ一部構造の一例を示す横面図。  FIG. 6A is a cross-sectional view illustrating an example of a partial structure of an adapter of an inner force table according to one or more embodiments of the present invention.
図 6 Bは、 本発明の一または一以上の実施例におけるインナ一力テーテ ルのアダプタ一部構造の一例を示す横面の透視図。  FIG. 6B is a perspective view of a lateral surface showing an example of a partial structure of the adapter of the inner force table according to one or more embodiments of the present invention.
図 7 Aは、 本発明の一または一以上の実施例における 2本のインナ一力 テーテルを装着するためアウターカテーテルのコネクタ一部に嵌合させるァタッ チメントの一例を示す概略図であり、 2本のインナーカテーテルを装着するため のアタッチメントの横から見た図。  FIG.7A is a schematic diagram showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting two inner force catheters in one or more embodiments of the present invention. FIG. 5 is a view from the side of an attachment for attaching the inner catheter of FIG.
図 7 Bは、 本発明の一または一以上の実施例における 2本のインナ一力 テーテルを装着するためアウターカテーテルのコネクタ一部に嵌合させるァタッ チメントの一例を示す概略図であり、 2本のィンナーカテーテルを装着するため のアタッチメントの上から見た図。 FIG. 7B illustrates two inner contacts in one or more embodiments of the invention. FIG. 4 is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for attaching a catheter, as viewed from above an attachment for attaching two inner catheters.
図 8 Aは、 本発明の一または一以上の実施例における 3本のインナ一力 テーテルを装着するためアウターカテーテルのコネクタ一部に嵌合させるァタッ チメントの一例を示す概略図であり、 3本のインナーカテーテルを装着するため のアタッチメントの横から見た図。  FIG.8A is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting three inner force catheters according to one or more embodiments of the present invention. FIG. 5 is a view from the side of an attachment for attaching the inner catheter of FIG.
図 8 Bは、 本発明の一または一以上の実施例における 3本のインナ一力 テーテルを装着するためアウターカテーテルのコネクタ一部に嵌合させるァタッ チメントの一例を示す概略図であり、 3本のインナーカテーテルを装着するため のアタッチメントの上から見た図。  FIG.8B is a schematic view showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting three inner force catheters according to one or more embodiments of the present invention. FIG. 2 is a view from above of an attachment for mounting the inner catheter.
図 9 Aは、 本発明の一または一以上の実施例におけるダブルルーメン形 状のィンナーカテーテルを装着するためアウターカテーテルのコネクタ一部に嵌 合させるアタッチメントの一例を示す概略図であり、 全体形状を示す概略図。  FIG. 9A is a schematic view showing an example of an attachment to be fitted to a part of a connector of an outer catheter for mounting a double-lumen inner catheter in one or more embodiments of the present invention. FIG.
図 9 Bは、 本発明の一または一以上の実施例におけるダブルルーメン形 状のインナーカテーテルを装着するためアウターカテーテルのコネクタ一部に嵌 合させるァタツチメントの一例を示す概略図であり、 ァタツチメントの構造を示 す概略図。  FIG.9B is a schematic diagram showing an example of an attachment fitted to a part of a connector of an outer catheter for mounting a double-lumen inner catheter according to one or more embodiments of the present invention. FIG.
図 1 O Aは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができるネジ式ァタ ツチメントの構造の一例を示す概略図であり、 アウターカテーテルとインナ一力 テーテルを装着した全体形状を示す概略図。  FIG. 1 OA is a schematic diagram showing an example of the structure of a screw-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. The schematic diagram which shows the whole shape which mounted | wore the outer catheter and the inner force catheter.
図 1 0 Bは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したインナーカテーテルの長さを微調整することができるネジ式ァタ ツチメントの構造の一例を示す概略図であり、 アタッチメントの構造を示す概略 図。  FIG. 10B is a schematic view showing an example of the structure of a screw-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
図 1 1 Aは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができる蛇腹式ァタ ツチメントの構造の一例を示す概略図であり、 アウターカテーテルとインナ一力 テーテルを装着した全体形状を示す概略図。 FIG. 11A illustrates a bellows-type device that can finely adjust the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. It is the schematic which shows an example of the structure of a tument, The schematic which shows the whole shape which mounted the outer catheter and the inner force catheter.
図 1 1 Bは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したインナーカテーテルの長さを微調整することができる蛇腹式ァタ ツチメントの構造の一例を示す概略図であり、 アタッチメントの構造を示す概略 図。  FIG. 11B is a schematic view showing an example of the structure of a bellows-type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
図 1 2 Aは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したインナーカテーテルの長さを微調整することができる組合せ式ァ タツチメントの構造の一例を示す概略図であり、 アウターカテーテルとインナー カテーテルを装着した全体形状を示す概略図。  FIG.12A is a schematic diagram showing an example of the structure of a combination type attachment that can finely adjust the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. FIG. 2 is a schematic diagram showing an overall shape in which an outer catheter and an inner catheter are mounted.
図 1 2 Bは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができる組合せ式ァ タツチメントの構造の一例を示す概略図であり、 アタッチメントの構造を示す概 略図。  FIG.12B is a schematic view showing an example of the structure of a combination type attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. Schematic diagram showing the structure of the attachment.
図 1 3 Aは、 本発明の一または一以上の実施例におけるアウターカテ一 テルに装着したィンナーカテーテルの長さを微調整することができる締め付け固 定式ァタツチメントの構造の一例を示す概略図であり、 アウターカテーテルとィ ンナーカテーテルを装着した全体形状を示す概略図。  FIG. 13A is a schematic diagram showing an example of the structure of a fixed fastening attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter in one or more embodiments of the present invention. FIG. 1 is a schematic view showing the overall shape of an outer catheter and an inner catheter.
図 1 3 Bは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができる締め付け固 定式アタッチメントの構造の一例を示す概略図であり、 アタッチメントの構造を 示す概略図。  FIG.13B is a schematic view showing an example of a structure of a fixed fastening attachment capable of finely adjusting the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. FIG. 2 is a schematic view showing the structure of an attachment.
図 1 3 Cは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができる締め付け固 定式アタッチメントの構造の一例を示す概略図であり、 アタッチメントにインナ 一カテーテルのロックリング 2 4が嵌合している概略図。  FIG.13C is a schematic view showing an example of a structure of a fixed fastening attachment that can finely adjust the length of an inner catheter attached to an outer catheter according to one or more embodiments of the present invention. The schematic diagram in which the lock ring 24 of the inner catheter is fitted to the attachment.
図 1 3 Dは、 本発明の一または一以上の実施例におけるアウターカテー テルに装着したィンナーカテーテルの長さを微調整することができる締め付け固 定式ァタツチメントの構造の一例を示す概略図であり、 ァタツチメントの内腔の 構造を示す概略図。 FIG. 13D shows a tightening fastener that can fine-tune the length of the inner catheter attached to the outer catheter in one or more embodiments of the present invention. FIG. 3 is a schematic view showing an example of the structure of a fixed attachment, and is a schematic view showing the structure of a lumen of the attachment.
図 1 4は、 本発明の一または一以上の実施例におけるインナ一力テーテ ル非使用時にアウターカテーテルに装着し内腔の血栓形成を防止するためのォブ チュレーター (内栓) の一例を示す概略図である。  FIG. 14 illustrates an example of an obturator (inner plug) attached to an outer catheter to prevent thrombus formation in a lumen when the inner power tail is not used in one or more embodiments of the present invention. It is a schematic diagram.
図 1 5は、 本発明の一または一以上の実施例におけるアウター力テーテ ルの内腔に形成された血栓を物理的に除去するためのデバイスの形状の一例を示 す概略図である。  FIG. 15 is a schematic diagram illustrating an example of the shape of a device for physically removing a thrombus formed in a lumen of an outer force tail according to one or more embodiments of the present invention.
図 1 6は、 本発明の一または一以上の実施例における皮下組織に密着さ せるためアウターカテーテルにカフを取り付けたカテーテルの概略図である。  FIG. 16 is a schematic diagram of a catheter with a cuff attached to an outer catheter for intimate contact with subcutaneous tissue in one or more embodiments of the present invention.
図 1 7は、 本発明の一または一以上の実施例における側注部を取り外し 交換できるアウターカテーテルの一例を示す概略図である。  FIG. 17 is a schematic diagram showing an example of an outer catheter in which a side injection portion can be removed and replaced in one or more embodiments of the present invention.
[符号の説明] [Explanation of symbols]
1 アウターカテーテル  1 Outer catheter
2 ィンナ一力テーテノレ  2 Vinna Teitenore
3 ォブチュレーター (内栓)  3 Obturator (internal stopper)
4 血栓を除去または回収するためのデバイス  4 Devices for removing or collecting thrombus
5 ダブノレノレーメン型カテーテノレ  5 Dubno Reno Remen Type Katatenore
6 ァタツチメント  6 Attachment
7 皮膚  7 skin
8 皮下組織  8 Subcutaneous tissue
9 血管  9 blood vessels
1 1 コネクタ一部  1 1 Connector part
1 2 クランプチューブ部  1 2 Clamp tube
1 3 糸掛部  1 3 Threading section
1 4 側注部  1 4 Side note
1 5 ハブ クランプ 1 5 hub Clamp
逆流防止弁 Check valve
ネジ部 Screw part
接続部 Connection
長さが短い方のインナーカテーテル Shorter inner catheter
長さが長い方のインナーカテーテル Longer inner catheter
アダプタ一部 Adapter part
ロックリング部 Lock ring section
雄ルアーテーパー部 Male luer taper
雌ルアーテーパー部 Female luer taper
弾性ゴム Elastic rubber
インナーカテーテルの先端 Tip of inner catheter
ロックリング内側のネジ形状 Screw shape inside lock ring
棒状ォブチュレーター本体 Rod-shaped obturator body
ループ状ワイヤー Loop wire
操作部 Operation unit
シース部 Sheath part
延長部 Extension
Y管部 Y tube
カフ Cuff
長さの微調整が可能なネジ式ァタツチメント Screw-type attachment with fine adjustment of length
長さの微調整が可能な蛇腹式アタッチメント Bellows attachment with fine adjustment of length
長さの微調整が可能な組合せ式アタッチメント 長さの微調整が可能な締め付け固定式ァタツチメント ァタツチメント本体のネジ構造 Combination type attachment with fine adjustment of length Tightened fixed attachment with fine adjustment of length Screw structure of attachment body
アタッチメント本体の伸縮自在の蛇腹式アタッチメント 複数の組合せ式ァタツチメント Elastic bellows type attachment of attachment body Multiple combination type attachment
アタッチメント本体の溝付ネジ構造 6 5 インナーカテーテル締め付け用ロックリング Slotted screw structure of attachment body 6 5 Lock ring for tightening the inner catheter
6 6 溝部 発明を実施するための最良の形態  6 6 Groove The best mode for carrying out the invention
以下、 本発明の一または一以上の実施例を詳細に説明する。  Hereinafter, one or more embodiments of the present invention will be described in detail.
本発明の一または一以上の実施例においては、 2以上の単層ルーメンカ テーテルまたは 1もしくは 2以上の複層ルーメンカテーテルから構成されるィン ナーカテーテルがアウターカテーテルと着脱可能に嵌合される。  In one or more embodiments of the present invention, an inner catheter composed of two or more single-layer lumen catheters or one or more multi-layer lumen catheters is removably fitted to the outer catheter.
本宪明ーまたは一以上の実施例において用いられるアウターカテーテル は、 従来のコアクシャル型カテーテルにおけるアウターカテーテルとして知られ ているものが同様に使用できる。  As the outer catheter used in the present invention or one or more embodiments, what is known as an outer catheter in a conventional coaxial catheter can be similarly used.
本発明一または一以上の実施例においてィンナーカテーテルとァウタ一 カテーテルを着脱可能に嵌合するための手段としては、 次のように種々の方法が 採用できる。  In one or more embodiments of the present invention, as a means for detachably fitting the inner catheter and the outer catheter, various methods can be adopted as follows.
a ) 複数本のインナーカテーテルが貫通し固定されたアダプタ一部をアウター力 テーテルのコネクタ一部に嵌め込み、 さらに嵌合部を口ックリング部でネジ締め する方法  a) A method in which a part of the adapter through which a plurality of inner catheters penetrates and is fixed is fitted into a part of the connector of the outer force catheter, and the fitting part is screwed with a mouth ring.
b ) 一本毎にインナーカテーテルが貫通し固定されたアダプタ一部を、 アウター カテーテルのコネクタ一部にインナーカテーテル毎に対応して形成した一体化し た接続部に嵌め込み、 ロックリングでネジ締めする方法  b) A method in which a part of the adapter, through which the inner catheter is penetrated and fixed, is inserted into an integrated connection part formed for each inner catheter in a part of the connector of the outer catheter, and screwed with a lock ring.
c ) b ) における接続部がアタッチメントを介してアウターカテーテルのコネク ター部にネジ止めする方法  c) Method of screwing the connection part in b) to the connector part of the outer catheter via the attachment
d ) インナーカテーテルの Y管部が揷入できるテーパー状の内孔を有する弹性ゴ ム製ァタツチメントをアウターカテーテルのコネクタ一部にネジ止めし、 その内 孔にインナーカテーテルを押し込む方法 以下図面を用いて説明する。  d) A method of screwing a rubber attachment having a tapered inner hole into which the Y-tube part of the inner catheter can be inserted into a part of the connector of the outer catheter, and pushing the inner catheter into the inner hole. explain.
図 1 Aは、 上記の a ) の方法により着脱可能に嵌合した血管留置用カテ  Fig. 1A shows the vascular indwelling catheter detachably fitted by the method a) above.
0 一テルの全体図を示している。 図 1 Aは、 嵌合方法を説明する便宜上、 インナー カテーテルのアダプタ一部をアウターカテーテルのコネクタ一部から外した状態 を示している。 インナーカテーテル 2はアダプタ一部 2 3に貫通して固定されて おり、 アダプタ一部 2 3の下部は雄ルアーテーパー 2 5となっている (図 6 A、 図 6 B参照) 。 アウターカテーテル 1のコネクタ一部 1 1はインナーカテーテル 2を固着したアダプタ一部 2 3と嵌合 ·接続できるように、 内腔は図 2 Aに示す ようなルアーテーパー構造 2 6を有している。 0 1 shows a general view of one tell. FIG. 1A shows a state in which a part of the adapter of the inner catheter is detached from a part of the connector of the outer catheter for convenience of explanation of the fitting method. The inner catheter 2 penetrates and is fixed to the adapter part 23, and the lower part of the adapter part 23 has a male luer taper 25 (see FIGS. 6A and 6B). The inner lumen has a luer taper structure 26 as shown in Fig. 2A so that the connector part 11 of the outer catheter 1 can be fitted and connected to the adapter part 23 to which the inner catheter 2 is fixed. .
アウターカテーテル 1のコネクタ一部 1 1の上部の接続部 2 0にはネジ 部 1 9が形成され、 ロックリング部 2 4でネジ締めされることによりアダプター ブ 2 3がコネクタ一部 1 1と着脱可能に嵌合することができる。  A screw portion 19 is formed at the upper connection portion 20 of the connector portion 1 1 of the outer catheter 1, and the adapter ring 23 is attached to and detached from the connector portion 11 by being screwed with the lock ring portion 24. Can be fitted as much as possible.
血管留置用カテーテルにおいて、 アウターカテーテルは血液の脱血また は送血のルーメンとして使用することができる側注部 1 4、 カテーテルと皮膚と を縫合糸で固定するための糸掛部 1 3を備えている。 また、 インナ一力テーテノレ 2の手元側チューブおよびアウターカテーテル 1の側注部 1 4に接続するチュー ブには、 体外循環回路などのラインやシリンジ等に接続するためのハブ 1 5が設' けられ、 また内腔を一時的に遮断するためのクランプ 1 6が備わっている。  In a catheter for indwelling a blood vessel, the outer catheter has a side injection portion 14 that can be used as a lumen for blood removal or blood transmission, and a thread hook portion 13 for fixing the catheter to the skin with a suture. ing. In addition, a hub 15 for connecting to a line such as an extracorporeal circulation circuit, a syringe, or the like is provided on a tube connected to the proximal side tube of the inner power catheter 2 and the side injection section 14 of the outer catheter 1. And a clamp 16 to temporarily block the lumen.
また、 アウターカテーテルは図 1 7に一例を示す様に、 長期間の繰り返 し使用が可能となるよう破損などトラブルの起こりやすい側注部のクランプチュ ーブ部 1 2、 クランプ 1 6、 ハブ 1 5部分を取り外し交換できる構造をとること もできる。 この場合、 アウターカテーテル 1は糸掛部 1 3、 クランプチューブ部 1 2、 コネクタ一部 1 1からなる。  Also, as shown in Fig. 17, the outer catheter can be used repeatedly for a long period of time. It is also possible to adopt a structure in which 15 parts can be removed and replaced. In this case, the outer catheter 1 is composed of a thread hook portion 13, a clamp tube portion 12, and a connector part 11.
インナーカテーテルは、 目的に応じて本数、 長さ、 ルーメンの数が選択 される。 例えば、 中心静脈栄養用のカテーテルとして使用する場合は、 インナー カテーテルに輸液が投与される。 一方、 血液浄化などの体外循環に使用する場合 は、 図 1 Aおよび図 1 Bに示した様に、 脱送血のための長さの異なる 2本 (2 1 および 2 2 ) のインナーカテーテル 2を接続して、 血液を循環させることができ る。  The number, length, and number of lumens of the inner catheter are selected according to the purpose. For example, when used as a catheter for central parenteral nutrition, the infusion is administered to an inner catheter. On the other hand, when used for extracorporeal circulation such as blood purification, as shown in Fig. 1A and Fig. 1B, two inner catheters (21 and 22) with different lengths for blood removal are used. Can be connected to circulate blood.
さらに、 インナーカテーテル 2には、 そのルーメンを通じて脈圧、 血流 量等の各種センサーおよび心臓ぺーシング用の電極が装着されていてもよく、 そ のような血管内留置用カテーテルは、 治療用途、 診断用途としても利用できる。 センサーとしては、 カテーテルの内腔に埋め込み電気信号等を感知する金属線状 のものが挙げられる。 In addition, the inner catheter 2 has pulse pressure and blood flow through its lumen. Various sensors for the amount and the like and electrodes for cardiac pacing may be mounted. Such an intravascular indwelling catheter can also be used for therapeutic use and diagnostic use. Examples of the sensor include a metal wire sensor embedded in a lumen of a catheter and sensing an electric signal or the like.
サーモダイリューシヨンカテーテルを例にとると、 血流量を測定する場 合にはカテーテルの手元側から氷冷した生理食塩水を流し先端側のセンサーで温 度を測定した時の血液の温度希釈度により測定する。 圧力測定に関しては、 カテ 一テル先端に設けられたバルーン内に空気を注入し、 バルーンにかかる圧を手元 側の圧力センサーで測定する方法もある。  Taking a thermodilution catheter as an example, when measuring the blood flow, the temperature dilution of the blood when the ice-cold physiological saline is poured from the proximal side of the catheter and the temperature is measured by the sensor at the tip side Measured by As for pressure measurement, there is a method in which air is injected into a balloon provided at the tip of the catheter, and the pressure applied to the balloon is measured by a pressure sensor at hand.
心臓ぺーシング用電極としては、 カテーテルの先端と手元側の 2力所に 設けられて、 電極は体外部の体外式ペースメーカーのジェネレ-ターに接続する ことによりぺーシングを行う。  Electrodes for cardiac pacing are provided at two points on the distal end of the catheter and on the proximal side. The electrodes are connected to an external pacemaker generator outside the body to perform pacing.
クランプ 1 6の形状については指で押さえてチューブを閉止させるピン チ式、 または板状のものに幅が段階的に狭くなるスリットが入り、 スリットをス ライドさせることによりチューブを閉止するスリット式などの形状があるが、 チ ユーブを閉塞させる機能を有するものであれば形状は問わない。  For the shape of the clamp 16, use a pinch type that closes the tube by pressing it with a finger, or a slit type that closes the tube by sliding a slit into a plate-shaped object with a gradually decreasing width. The shape is not particularly limited as long as it has a function of closing the tube.
また、 図 2 Bに示すように、 インナーカテーテル 2またはォブチユレ一 タ一 3を装着する際に血液が体外に洩れることをできる限り抑える逆流防止弁の 構造 1 8を採ることが好ましいが、 なくても使用は可能である。 逆流防止弁の構 造は、 例えばスリ ッ トの入った弾性ゴムの厚みをもつ層であることもあるが、 血 液等の液体が漏れない構造のものであれば材質、 構造は特に限定するものではな レ、。  In addition, as shown in FIG. 2B, it is preferable to adopt a check valve structure 18 that minimizes the leakage of blood outside the body when the inner catheter 2 or the obturator 13 is attached. Can also be used. The structure of the check valve may be, for example, a layer with a thickness of elastic rubber containing a slit, but the material and structure are not particularly limited as long as the structure does not leak liquid such as blood. Not something.
カテーテルの材質は、 体内、 特に血管内に留置して安全な弾性のある材 質であれば良く、 例えば、 ポリウレタン、 シリコーン、 ポリ塩化ビュル、 ポリブ タジェン、 ポリアミ ド、 エチレン一酢酸ビニル共重合体等が挙げられるが、 好ま しくは体外では硬度を保ち体内で柔軟性をもつ性質をもつポリウレタンが好まし い。  The catheter may be made of any material that is safe and elastic when placed in the body, especially in blood vessels.Examples include polyurethane, silicone, polyvinyl chloride, polybutadiene, polyamide, and ethylene-vinyl acetate copolymer. However, polyurethane, which has the property of maintaining hardness outside the body and being flexible inside the body, is preferred.
アウターカテーテル 1は、 図 1 6に示したような、 皮下組織 8と密着さ せる機能を有するカフ 5 2が皮膚 7刺入部から血管 9刺入部までの間の力テーテ ル部分の 1箇所、 または 2箇所以上取り付けられているものであってもよい。 The outer catheter 1 is in close contact with the subcutaneous tissue 8 as shown in Fig. 16. The cuff 52 having the function of causing the cuff 52 to be attached may be attached at one or more of the force table portions between the skin 7 penetration portion and the blood vessel 9 penetration portion.
カフの形状としては、 繊維の綿状のもの、 スポンジ状のもの、 力テーテ ルの一部が盛り上がつたもの等が挙げられ、 材質としては、 ポリエステル、 ナイ ロン、 アクリル等の合成高分子化合物または綿、 絹、 キチンなどの天然高分子化 合物等が挙げられる。 本発明における他の嵌合方法としては、 上記 b ) のように、 一本毎にィ ンナーカテーテルが貫通し固定されたアダプタ一部を、 アウターカテーテルのコ ネクター部にインナーカテーテル毎に対応して形成した一体化した接続部 2 0に 嵌め込み、 ロックリングでネジ締めする方法が採用できる。 具体的には図 3 A〜 図 4 Bに示されている。 図 3 Aおよび図 3 Bはインナーカテーテルが 2本の場合 、 図 4 Aおよび図 4 Bはインナーカテーテルが 3本の場合を示している。 接続部 2 0は、 アウターカテーテル 1のコネクタ一部 1 1の上部に、 インナ一力テーテ ノレ 2の 1本ごとに対応して形成されており、 コネクタ一部 1 1と一体化している 。 接続部 2 0の口部にはロックリング 2 4がネジ締めされるようにネジ 1 9が形 成されている。 図 3 A〜図 4 Bに示した血管内留置用カテーテルでは、 インナー カテーテル 2を洗浄あるいは交換のために取り外すときには、 目的のィンナ一力 テーテルの口ックリング 2 4を外すことで可能となる。 本発明における別の嵌合方法としては、 上記 c ) のように、 b ) におけ る接続部がァタツチメントを介してアウターカテーテルのコネクタ一部 1 1に直 接ネジ止めする方法が挙げられる。 具体的には、 図 7 A〜図 8 Bに示されており 、 図 7 Aおよび図 7 Bはインナーカテーテルが 2本の場合、 図 8 Aおよび図 8 B はインナーカテーテルが 3本の場合を示している。 この態様では、 インナ一力テ 一テル 2毎に対応して形成される接続部 2 0がアタッチメントと一体化しており 、 このアタッチメントの内腔にはネジが切られ、 アウターカテーテルのコネクタ 一部の口部にネジ止めされる。 さらに、 本発明における別の嵌合方法としては、 上記 d ) のように、 ィ ンナ一カテーテルの Y管部が挿入できるテーパー状の内孔を有する弾性ゴム製ァ タツチメントをアウターカテーテルのコネクタ一部にネジ止めし、 その内孔にィ ンナーカテーテルを押し込む方法が挙げられる。 具体的には、 図 9 Aおよび図 9 Bに示されている。 図 9 Aに開示するダブルル一メンカテーテノレ 5の Y管部 5 1 の形状とほぼ合致するような構造をもつァタツチメント 6をアウターカテーテル のコネクタ一部 1 1に接続することができる。 このアタッチメント 6の嵌合部の 一部である弾性ゴム層 2 7の形状を、 装着するそれぞれのカテーテルの Y管部 5 1の形状に合わせることにより、 様々な形状をもつカテーテルを本発明のァウタ 一カテーテル 1に接続することが可能となる。 なお、 アウターカテーテル 1とインナーカテーテル 2を接続するァタツ チメントを工夫することにより、 アウターカテーテル 1に接続した状態でインナ —カテーテルの長さを微調整できる構造とすることもできる。 The shape of the cuff includes a cotton-like fiber, a sponge-like one, a part of a force table with a raised portion, and the like.The material is a synthetic polymer such as polyester, nylon, and acrylic. Compounds or natural polymer compounds such as cotton, silk, chitin and the like. As another fitting method in the present invention, as described in b) above, a part of the adapter in which the inner catheter penetrates and is fixed one by one to the connector part of the outer catheter corresponding to each inner catheter. A method of fitting into the formed integrated connection part 20 and tightening the screws with a lock ring can be adopted. Specifically, this is shown in FIGS. 3A to 4B. 3A and 3B show the case where there are two inner catheters, and FIGS. 4A and 4B show the case where there are three inner catheters. The connection part 20 is formed on the upper part of the connector part 11 of the outer catheter 1 so as to correspond to each one of the inner force catheters 2 and is integrated with the connector part 11. A screw 19 is formed at the mouth of the connection part 20 so that the lock ring 24 is screwed. In the catheter for indwelling in a blood vessel shown in FIGS. 3A to 4B, when the inner catheter 2 is removed for cleaning or replacement, it is possible to remove the mouth ring 24 of the intended inner force catheter. As another fitting method in the present invention, as in the above c), there is a method in which the connection portion in b) is directly screwed to the connector portion 11 of the outer catheter via an attachment. Specifically, FIGS.7A to 8B show the case where two inner catheters are used in FIGS.7A and 7B, and the case where three inner catheters are used in FIGS.8A and 8B. Is shown. In this embodiment, the connection part 20 formed corresponding to each inner power catheter 2 is integrated with the attachment. The inner lumen of this attachment is threaded, and a part of the connector of the outer catheter is provided. Screwed to the mouth. Further, as another fitting method in the present invention, as described in d) above, an elastic rubber attachment having a tapered inner hole into which the Y-tube portion of the inner catheter can be inserted is partially connected to the connector of the outer catheter. Then, the inner catheter is pushed into the inner hole by a screw. Specifically, this is shown in FIGS. 9A and 9B. Attachment 6 having a structure substantially matching the shape of Y-tube portion 51 of double lumen catheter 5 disclosed in FIG. 9A can be connected to connector portion 11 of the outer catheter. By adjusting the shape of the elastic rubber layer 27, which is a part of the fitting portion of the attachment 6, to the shape of the Y-tube portion 51 of each catheter to be mounted, catheters having various shapes can be formed according to the present invention. One catheter 1 can be connected. By devising an attachment for connecting the outer catheter 1 and the inner catheter 2, a structure in which the length of the inner catheter can be finely adjusted while connected to the outer catheter 1 can be employed.
そのような一例として、 図 1 O Aおよび図 1 0 Bにはァタツチメント本 体部分をネジ構造 5 3として、 これに嵌合するロックリング 2 4部分を回転させ てアウターカテーテル 1に嵌合する長さを調節するものを示している。 この他、 インナ一カテーテル 2のアダプタ一部 2 3のロックリング部分 2 4を回転させて アタッチメントの長さを調節する方法もある。  As one example, FIGS. 1OA and 10B show the attachment body as a threaded structure 53, and the lock ring 24 fitted thereto is rotated to fit the outer catheter 1. Are shown to adjust In addition, there is a method of rotating the lock ring portion 24 of the adapter portion 23 of the inner catheter 2 to adjust the length of the attachment.
ィンナーカテーテルの長さの微調整はカテーテルの先端が血管壁に対し て接触しない位置に変更する等の目的で行われるが、 微調整する長さは 5 c m以 内が好ましいが、 1〜2 c mの範囲で機能を果たすことがさらに好ましい。 インナーカテーテルの長さを微調整する他の方法としては、 図 1 1 Aお よび図 1 1 Bに示すような蛇腹式のアタッチメント 5 4の他、 図 1 2 Aおよび図 1 2 Bに示すような複数の着脱式アタッチメント 5 5の組合せであってもよく、 さらに図 1 3 A〜図 1 3 Dに示すようなロックリングを締め付けながら長さを調 整および固定するァタツチメント 5 6であってもよレ、。 長さの微調整の範囲は先 述した通りである。 インナーカテーテルの長さを微調整するための方法としては、 上記のァ タツチメントの他、 アタッチメントの構造がアウターカテーテル 1のコネクター 部と一体化していてもよレ、。 血管内留置用カテーテルにおいては、 インナーカテーテル 2の未使用時 にアウターカテーテル内腔に血栓が形成されて閉塞することを防止するために、 図 1 4に示すようなォブチュレーター (内栓) 3を装着することもできる。 Fine adjustment of the length of the inner catheter is performed for the purpose of changing the tip of the catheter to a position where it does not contact the blood vessel wall, etc., but the length of the fine adjustment is preferably within 5 cm, More preferably, the function is performed in the range of cm. Other methods for fine-tuning the length of the inner catheter include bellows-type attachments 54 as shown in FIGS. 11A and 11B, as well as those shown in FIGS. 12A and 12B. It may be a combination of multiple detachable attachments 55, and adjust the length while tightening the lock ring as shown in Figs.13A to 13D. Attachment 5 6 to fix and fix. The range of the fine adjustment of the length is as described above. As a method for finely adjusting the length of the inner catheter, in addition to the above attachment, the structure of the attachment may be integrated with the connector portion of the outer catheter 1. In order to prevent the formation of a thrombus in the lumen of the outer catheter and blockage when the inner catheter 2 is not used, an obturator (inner plug) as shown in Fig. Can also be attached.
ォブチュレーター 3の構造としては、 アウターカテーテルの内腔閉塞さ せる太さの棒状ォブチュレーター本体 3 1とアウターカテーテル 1に装着させる ためのアダプター 2 3の構造を有していればよい。 アダプター 2 3の構造はイン ナ一カテーテル 2のものと基本的には同じでよい。 一方、 ォブチュレーター 3を使用せずにへパリン等の抗凝固剤をァウタ 一カテーテル 1の内腔に充填することも可能であるが、 万一、 血栓が形成された 場合、 一例として、 図 1 5に示すような血栓を除去または回収するデバイス 4を 装着して血栓を物理的に除去または回収することも可能である。  The structure of the obturator 3 only needs to have the structure of a rod-shaped obturator main body 31 having a thickness to close the inner lumen of the outer catheter and an adapter 23 to be attached to the outer catheter 1. The structure of the adapter 23 may be basically the same as that of the inner catheter 2. On the other hand, it is also possible to fill the lumen of the catheter 1 with an anticoagulant such as heparin without using the obturator 3, but if a thrombus is formed, one example is shown in FIG. It is also possible to physically remove or collect a thrombus by attaching a device 4 for removing or collecting a thrombus as shown in 15.
血栓を除去または回収するデバイスの構造としては、 その一例として血 栓等の目的物をつかむためのループ状のワイヤー部 4 1が挙げられるが、 ワイヤ 一部 4 1の形状は血栓を除去または回収できる構造をとるものであれば特に問わ ない。 またワイヤー部 4 1を実際にカテーテルから出し入れするための操作部 4 2があり、 アウターカテーテルのコネクタ一部 1 1に嵌合させるためのアダプタ 一部 2 3を有する。 アダプタ一部 2 3の構造はインナーカテーテル 2のものと基 本的には同じでよい。  An example of the structure of a device for removing or collecting a thrombus is a loop-shaped wire portion 41 for grasping an object such as a thrombus, but the shape of the wire portion 41 is to remove or collect a thrombus. There is no particular limitation as long as it has a structure that allows it. There is also an operation part 42 for actually putting the wire part 41 in and out of the catheter, and an adapter part 23 for fitting the connector part 11 of the outer catheter. The structure of the adapter part 23 may be basically the same as that of the inner catheter 2.
また、 血栓を除去または回収するデバイス 4の構造はワイヤー状以外に も吸引力により血栓を除去または回収する方法であってもよい。 本発明の血管内留置用カテーテルは、 留置中に血液に接触して血栓が形 成されるのを防ぐために、 抗血栓性処理が施されていてもよい。 Further, the structure of the device 4 for removing or collecting thrombus may be a method of removing or collecting thrombus by suction force, instead of the wire shape. The intravascular indwelling catheter of the present invention may be subjected to an antithrombotic treatment in order to prevent formation of a thrombus due to contact with blood during indwelling.
抗血栓性処理には、 ゥロキナーゼ等のプラスミノーゲンァクチベータ一 を化学結合法により基材のカテーテル表面に固定ィヒする方法 (詳細は、 特許 1 4 0 6 8 3 0号参照) 、 へパリン等の抗凝固因子をカテーテル表面にコーティング する方法等様々な方法が開発されているが、 特定の方法に限定されるものではな い。  For the antithrombotic treatment, a method of immobilizing plasminogen activator such as perokinase on the surface of the base catheter by a chemical bonding method (for details, see Patent No. 1406803). Various methods have been developed, such as a method of coating a catheter surface with an anticoagulant factor such as palin, but the method is not limited to a specific method.
また、 抗血栓性処理の範囲は血液に接触する部分であればカテーテルの 外面、 内面またはその両方であってもよい。  In addition, the range of the antithrombotic treatment may be the outer surface, the inner surface, or both of the catheter as long as the portion comes into contact with blood.
本発明の血管内留置用カテーテルは、 カテーテル留置中に細菌や真菌、 ウィルスなどに感染することを防止するため、 基材の力テ一テルの全体または一 部の表面に抗菌剤や抗生物質などがコーティングしているもの (例えば、 特開 2 0 0 1 - 2 7 6 2 1 0号公報参照) や、 抗菌剤が基材に直接混練されているもの (例えば、 特開平 8 - 1 5 7 6 4 1号公報参照) であってもよい。  The catheter for indwelling in the blood vessel according to the present invention includes an antibacterial agent, an antibiotic, or the like on the entire or part of the surface of the force sensor of the base material to prevent infection with bacteria, fungi, viruses, and the like during the indwelling of the catheter. (See, for example, JP-A-2001-276210) and those in which an antibacterial agent is directly kneaded into a substrate (for example, see JP-A-8-157). 641).
本発明の血管内留置用カテーテルは、 皮下組織または血管への揷入を容 易にするため、 基材表面を親水性高分子化合物でコーティングするなどの潤滑性 処理が施されているもの (例えば、 特開平 1 0 - 2 4 8 9 1 9号公報参照) であ つてもよい。 潤滑性処理する方法は多くの方法が開発されているが、 特にどの方 法を選択してもよい。 また、 潤滑性処理の範囲は人体に接触する部分、 または力 テーテルを留置する用具等に接触する部分であれば特にどの部分であってもよい  The catheter for indwelling in a blood vessel of the present invention has been subjected to a lubricating treatment such as coating the surface of a base material with a hydrophilic polymer compound in order to facilitate penetration into a subcutaneous tissue or a blood vessel (for example, And Japanese Patent Application Laid-Open No. 10-248919. Many methods have been developed for lubricating treatment, but any method may be selected. The range of the lubricating treatment may be any part as long as it is a part that comes into contact with the human body or a part that comes into contact with a tool for placing the force catheter.
本発明を詳細にまた特定の実施態様を参照して説明したが、 本発明の精 神と範囲を逸脱することなく様々な変更や修正を加えることができることは当業 者にとって明らかである。 Although the present invention has been described in detail and with reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention.
本出願は、 2004年 6月 10日出願の 13本特許出願 (特願 2004— 172729) に基づくものであり、 その内容はここに参照として取り込まれる。 産業上の利用可能性 This application is based on 13 patent applications filed on June 10, 2004 (Japanese Patent Application No. 2004-172729), the contents of which are incorporated herein by reference. Industrial applicability
本発明の一または一以上の実施例は、 血管内に留置された 1本のァウタ 一カテーテルに様々な目的に適した形状及び本数のィンナーカテーテルの選択的 装着が可能で、 閉塞等のトラブルが生じた時には長さあるいは太さ等が異なる新 たなインナーカテーテルを簡便に、 かつ必要な数だけ交換が可能であり、 結果的 に長期にわたり,継続的に留置できる血管内留置用カテーテルを提供する。 特にァ ウタ一カテーテルについてはそれ自身に問題が起こらない限り基本的に目的が終 了するまで継続して利用できるので、 1ヶ月、 1年単位の長期にわたり使用される 中心静脈栄養用をはじめとして様々な目的に有用である。  One or more embodiments of the present invention can selectively mount one inner catheter indwelled in a blood vessel to a catheter and a shape suitable for various purposes and a number of inner catheters. In the event of occurrence of an insufficiency, a new inner catheter with a different length or thickness can be easily replaced as many times as necessary, and as a result, a catheter for indwelling indwelling that can be indwelled continuously for a long period of time is provided. I do. In particular, since catheters can be used continuously until the end of the purpose, unless there is a problem with the catheter itself, such as for central parenteral nutrition, which is used over a long period of one month or one year Useful for various purposes.
7 7

Claims

1 . アウターカテーテルと、 1. An outer catheter,
前記アウターカテーテルのルーメン内に挿通され前記アウター力テーテ ルと着脱可能に嵌合するィンナーカテーテルと、 からなり、  An inner catheter that is inserted into the lumen of the outer catheter and detachably fits with the outer force table.
前記インナーカテーテルが、 2以上の単層ルーメンカテーテル、 または 、 1もしくは 2以上の複層ルーメンカテーテルからなる、  The inner catheter is composed of two or more single-layer lumen catheters, or one or two or more multi-layer lumen catheters,
 Blue
血管内留置用力テーテノレ。 の  Force for indwelling in a blood vessel. of
2 . インナーカテーテルを構成する 2以上の単層ルーメンカテーテルまたは 複層ルーメンカテーテルが、 各々別個に着脱可能である、  2. Two or more single-layer lumen catheters or multiple-layer lumen catheters that constitute the inner catheter are each separately detachable,
請求項 1記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
3 . インナ一カテーテルのルーメンを通じて治療用又は診断用センサ一が装 着されている、 3. A therapeutic or diagnostic sensor is mounted through the lumen of the inner catheter.
請求項 1記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
4 . ィンナーカテーテルのルーメンを通じて治療用又は診断用センサ一が装 着されている、 4. A therapeutic or diagnostic sensor is mounted through the lumen of the inner catheter.
請求項 2記載の血管内留置用力テーテル。  The force catheter for indwelling in a blood vessel according to claim 2.
5 . インナーカテーテルのルーメンを通じて心臓ペースメーカー用の電極が 装着されている、 5. The electrode for the cardiac pacemaker is attached through the lumen of the inner catheter,
請求項 1記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
6 . ィンナーカテーテルのルーメンを通じて心臓ペースメーカー用の電極が 装着されている、 6. The electrode for the cardiac pacemaker is attached through the lumen of the inner catheter.
請求項 2記載の血管内留置用カテーテル。 3. The intravascular indwelling catheter according to claim 2.
7 . 更に、 7.
前記ァゥターカテーテルに設けられたコネクタ一部と、  A connector part provided on the arter catheter,
前記コネクターと一体化して前記コネクタ一部の上部に設けられた複数 の接続部と、  A plurality of connecting portions integrated with the connector and provided on an upper part of the connector;
それぞれの前記接続部に設けられたネジと、  A screw provided at each of the connection portions,
前記インナーカテーテルのそれぞれに設けられ、 前記ネジとネジ締めさ れる、 口ックリングと、  A mouth ring provided on each of the inner catheters and screwed together with the screw,
からなる、 請求項 1に記載の血管内留置用カテーテル。  The catheter for indwelling in a blood vessel according to claim 1, comprising:
8 . 更に、 8. Furthermore,
前記アウターカテーテルに設けられたコネクタ一部と、  A connector provided on the outer catheter,
前記コネクタ一部にネジ止めされるアタッチメントと、  Attachment screwed to the connector part,
前記ァタツチメントと一体的に設けられた複数の接続部と、  A plurality of connecting portions provided integrally with the attachment;
からなり、  Consisting of
前記インナーカテーテルのそれぞれは、 前記接続部を介して、 前記ァゥ ターカテーテルと接続される、  Each of the inner catheters is connected to the catheter via the connection portion.
請求項 1に記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
9 . 更に、 9.
前記アウターカテーテルに設けられたコネクタ一部と、  A connector provided on the outer catheter,
前記インナーカテーテルに設けられ、 前記コネクタ一部にネジ止めされ る Y管部と、  A Y-tube portion provided on the inner catheter and screwed to a part of the connector;
からなる、 請求項 1に記載の血管内留置用カテーテル。  The catheter for indwelling in a blood vessel according to claim 1, comprising:
1 0 . 更に、 1 0.
前記アウターカテーテルと、 前記インナーカテーテルとを接続する、 ァ タツチメント、 からなり、 前記アタッチメントは、 長さを調節可能な、 ネジ構造を有する、 請求項 1に記載の血管内留置用カテーテル。 An attachment for connecting the outer catheter and the inner catheter, The catheter for indwelling in a blood vessel according to claim 1, wherein the attachment has a screw structure whose length is adjustable.
1 1 . 更に、 1 1.
前記アウターカテーテルと、 前記インナーカテーテルとを接続し、 長さ を調節可能な蛇腹式アタッチメント、 からなる、  The outer catheter and the inner catheter are connected to each other, and a bellows-type attachment whose length is adjustable,
請求項 1に記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
1 2 . 更に、 1 2.
前記アウターカテーテルと、 前記インナーカテーテルとを接続する、 複 数の着脱式アタッチメント、 からなり、  A plurality of detachable attachments for connecting the outer catheter and the inner catheter,
前記着脱式アタッチメントの装着個数を変更することにより、 アタッチ メント全体の長さを調整可能な、  By changing the number of attachments of the detachable attachment, the entire length of the attachment can be adjusted,
請求項 1に記載の血管内留置用カテーテル。  2. The intravascular indwelling catheter according to claim 1.
PCT/JP2005/010747 2004-06-10 2005-06-07 Intravascular indwelling catheter WO2005120621A1 (en)

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