WO2016021592A1 - Instrument d'aide à l'introduction avec trou latéral - Google Patents

Instrument d'aide à l'introduction avec trou latéral Download PDF

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Publication number
WO2016021592A1
WO2016021592A1 PCT/JP2015/072071 JP2015072071W WO2016021592A1 WO 2016021592 A1 WO2016021592 A1 WO 2016021592A1 JP 2015072071 W JP2015072071 W JP 2015072071W WO 2016021592 A1 WO2016021592 A1 WO 2016021592A1
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WO
WIPO (PCT)
Prior art keywords
side hole
introduction
tubular body
rigid portion
tubular
Prior art date
Application number
PCT/JP2015/072071
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English (en)
Japanese (ja)
Inventor
保裕 高橋
岡田　浩孝
Original Assignee
株式会社カテラ
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 株式会社カテラ filed Critical 株式会社カテラ
Publication of WO2016021592A1 publication Critical patent/WO2016021592A1/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
    • 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
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to an introduction assisting device that includes a tubular body that is inserted into a tubular organ of a human body and that can introduce a medical device into the tubular organ through the tubular body.
  • an introduction assisting instrument such as a sheath introducer as described in Patent Document 1 or a guiding catheter as described in Patent Document 2 is inserted into the tubular organ, and after placement, A therapeutic instrument such as a therapeutic catheter is introduced into the lesion site through the internal passage of the introduction assisting instrument.
  • the guide wire for the treatment instrument When introducing a treatment instrument to a lesion site through an introduction aid placed in a tubular organ, first insert a guide wire for the treatment instrument into the internal passage of the introduction aid placed in the tubular organ. After the distal end reaches the vicinity of the lesion site, the proximal end of the guide wire for the treatment instrument is inserted into the distal end of the treatment instrument such as a treatment catheter, and the treatment instrument is guided along the guide wire for the treatment instrument to the lesion site. invite. At this time, the guide wire for the therapeutic instrument or the therapeutic instrument is advanced by transmitting the pushing force applied to the therapeutic instrument guide wire or the therapeutic instrument from the base end side (the operation side at hand of the doctor) to the distal end. .
  • introduction blood vessel a blood vessel into which an introduction assisting device is inserted
  • introduction blood vessel a blood vessel into which an introduction assisting device is inserted
  • the introduction assisting device having a curved portion formed in advance so that the distal end of the introduction assisting device can be easily oriented toward the entrance of the target side branch blood vessel
  • the distal end of the introduction assisting device is moved to the side branch blood vessel.
  • a treatment instrument guide wire or a treatment instrument (hereinafter referred to as a guide wire or the like) is extended from the distal end of the introduction assisting instrument and inserted into the side branch vessel for treatment.
  • Patent Document 3 proposes a sheath with a side hole in which a flexible tube of the sheath tube is provided with a side hole smaller than the diameter of the internal passage, and a catheter that cannot pass through the side hole is extended from the distal end opening of the sheath tube.
  • a blood vessel such as a human body is bent or meandered in a complicated manner, and an introduction aid, particularly a tubular body part inserted into the blood vessel, is made of a flexible material so that it can be flexibly deformed along such a blood vessel. It is formed.
  • the introduction assisting device is preferably as small as possible in order to facilitate insertion, and the tubular body portion has an inner diameter that is slightly larger than the outer diameter of the catheter that is desired to be introduced into the target site. It is common to use what has.
  • the object of the present invention is to solve the problems existing in the prior art, and in the introduction aid with a side hole, the portion provided with the side hole is crushed while ensuring the flexibility of the tubular body inserted into the tubular organ. And to reduce the occurrence of kinks.
  • the present invention includes a tubular body that is inserted into a tubular organ of a human body, and a side hole is provided in a peripheral wall of the tubular body, and the medical instrument is inserted into the tubular organ through the side hole of the tubular body.
  • a side hole introduction assisting device wherein the tubular body is provided with a flexible portion that can be bent, and is provided at an intermediate portion of the flexible portion and more than the flexible portion.
  • An introduction assisting device with a side hole is provided that includes a rigid portion having high rigidity, and a slit is formed in a peripheral wall of the rigid portion so as to impart flexibility to the rigid portion.
  • the side hole is provided in a rigid portion having rigidity higher than that of the flexible portion mainly constituting the tubular body, and the strength is reduced by providing the side hole. It is possible to compensate for this by increasing the rigidity of the material, and to reduce the occurrence of crushing and kinking in the portion provided with the side holes. Moreover, by forming a slit in the peripheral wall of the rigid portion where the side hole is provided, the flexibility is increased and the tubular body can be inserted easily.
  • each of both ends of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and the slit is formed on the peripheral wall of both ends of the rigid portion.
  • the plurality of slits extend in the longitudinal direction and are spaced apart from each other in the circumferential direction. In this case, it is preferable that the plurality of slits extending in the longitudinal direction of the tubular body are tapered toward the central portion of the rigid portion.
  • the slit may extend in the circumferential direction or in an oblique direction with respect to the circumferential direction on the peripheral wall of the rigid portion. It is preferable that the slits are a plurality of slits formed at intervals in the direction of the longitudinal axis of the tubular body on the peripheral wall of the rigid portion. In this case, the plurality of slits may be alternately provided on opposite sides of the peripheral wall of the rigid portion.
  • each of the end portions of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and a plurality of slits extending in the longitudinal direction of the tubular body are provided. You may make it form in the surrounding wall of the both ends of the said rigid part at intervals in the circumferential direction.
  • the slit is more preferably tapered toward the center of the rigid portion.
  • the introduction assisting device with a side hole can be, for example, a sheath introducer, a guiding catheter, or a stenosis penetration catheter.
  • the side hole is provided in a rigid part having rigidity higher than that of the flexible part mainly constituting the tubular body, thereby preventing the occurrence of crushing and kinking in the part provided with the side hole. Can be reduced. Moreover, since the slit is provided in the rigid portion, the flexibility in the rigid portion provided with the side hole is ensured, and the tubular body can be easily inserted.
  • FIG. 6 is an enlarged view showing a second modification of the rigid portion shown in FIG. 2.
  • FIG. 2 shows the 3rd modification of the rigid part shown by FIG.
  • 2nd Embodiment of the rigid part of the introduction assistance instrument with a side hole It is explanatory drawing which shows other embodiment of the introduction assistance instrument with a side hole by this invention.
  • the introduction assisting device 11 is inserted into a tubular organ such as a blood vessel (hereinafter referred to as an introduction tubular organ), and introduces a medical device 21 such as a guide wire or a treatment device into a side branch tubular organ branched from the introduction tubular organ. It is an instrument to make it easier.
  • a tubular organ such as a blood vessel (hereinafter referred to as an introduction tubular organ)
  • a medical device 21 such as a guide wire or a treatment device into a side branch tubular organ branched from the introduction tubular organ. It is an instrument to make it easier.
  • the introduction tubular organ is, for example, the ascending aorta or the descending aorta
  • the side branch tubular organ is, for example, the brachiocephalic artery, right subclavian artery, right common carotid artery, left common carotid artery, left common carotid artery, left clavicle branching from the ascending or descending aorta Inferior artery, left renal artery, right renal artery.
  • these are examples, and the introduction tubular organ and the side branch tubular organ are not limited thereto.
  • the introduction assisting device 11 will be described as an example of the introduction assisting device 11 using the sheath introducer.
  • the introduction assisting device 11 is not limited to a sheath introducer as long as it is a device for assisting the introduction of the medical device 21 into a tubular organ such as a human body. It can also be used as a catheter.
  • the introduction auxiliary instrument 11 includes a tubular body 13 extending along the central axis, an instrument body 15, a connection tube 17 extending from the instrument body 15, and a three-way switching valve 19.
  • the tubular body 13 is a flexible tube such as a sheath tube having an internal passage through which the medical instrument 21 can be inserted.
  • the instrument body 15 is a substantially cylindrical member such as a sheath hub formed of an appropriate synthetic resin material, and is externally fixed to the proximal end portion of the tubular body 13.
  • the connection tube 17 is a flexible tube formed of an appropriate synthetic resin material, and is connected to the instrument body 15 so as to communicate with the interior of the instrument body 15.
  • a three-way switching valve 19 is connected to the free end of the connection tube 17 (the end opposite to the end connected to the instrument body 15), and any one of the three ports can be operated by operating the lever. The two can be communicated.
  • Such a three-way switching valve is well-known and has nothing to do with the essential features of the present invention, so a detailed description of its structure is omitted.
  • the tubular body 13 includes a main body portion (that is, a flexible portion) 23 having flexibility, and a rigid portion 25 that is provided at an intermediate portion of the main body portion 23 and has higher rigidity than the main body portion. .
  • the “intermediate portion” means an arbitrary portion excluding both end portions of the main body portion 23.
  • the main body portion 23 is formed of, for example, a flexible synthetic resin material.
  • the rigid portion 25 is formed of a material having higher rigidity than the material forming the main body portion such as metal or hard synthetic resin.
  • the main body portion 23 and the rigid portion 25 may be connected by welding or an adhesive. Further, when the rigid portion 25 is formed of a synthetic resin material, the main body portion 23 and the rigid portion 25 can be integrally formed from different materials.
  • FIG. 2 shows a first embodiment of the rigid portion 25 of the introduction assisting device 11 shown in FIG.
  • a side hole 27 is provided in the peripheral wall of the rigid portion 25, and the side hole 27 functions to allow the medical instrument 21 inserted into the tubular body 13 from the instrument body 15 to pass therethrough and extend to the outside.
  • the size and shape of the side hole 27 can be arbitrarily selected as long as the medical instrument 21 can be passed through. can do.
  • a slit 29 extending in the transverse direction is formed on the peripheral wall of the rigid portion 25.
  • the “transverse direction” means a direction crossing the peripheral wall of the rigid portion 25 of the tubular body 13, that is, a circumferential direction of the peripheral wall of the rigid portion 25 of the tubular body 13 or a direction oblique to the circumferential direction.
  • a plurality of slits 29 are formed on the peripheral wall of the rigid portion 25 on the side where the side holes 27 are provided, and the longitudinal direction of the rigid portion 25 is provided. It is provided at intervals in the axial direction.
  • the plurality of slits 29 may be provided on the side opposite to the side where the side holes 27 are provided, as in the first modified form of the rigid portion 25 shown in FIG.
  • the stiffened portions 25 may be alternately provided in a staggered manner on opposite sides of the peripheral wall of the rigid portion 25 including the side where the side holes 27 are provided. Further, as shown in FIG. 5, the plurality of slits 29 may be formed to extend obliquely with respect to the circumferential direction.
  • the side hole 27 as described above is provided in the tubular body 13, the side hole 27 is arranged in advance at the entrance of the side branch tubular organ, and is inserted into the tubular body 13 from the instrument body 15.
  • the medical device 21 can be easily introduced into the side branch tubular organ. That is, when the medical device 21 is introduced into the side branch tubular organ, it is not necessary to bring the distal end of the tubular body 13 of the introduction assisting device 11 close to the inlet of the side branch tubular organ or to be inserted into the inlet of the side branch tubular organ.
  • the side hole 27 is formed by providing the side hole 27 in the rigid portion 25 having higher rigidity than the main body portion 23 and increasing the rigidity of the material forming the peripheral wall of the rigid portion 25. Therefore, the reduction in strength due to the removal of a part of the peripheral wall of the tubular body 13 is compensated. Therefore, the occurrence of crushing and kinking in the portion where the side hole 27 is provided is reduced.
  • the rigidity of the rigid portion 25 is enhanced by forming a slit 29 extending in the transverse direction. Therefore, even if the rigid part 25 is included in a part of the tubular body 13, it can be flexibly deformed in accordance with the curvature of the introduction tubular conduit, and the insertion work of the tubular body 13 into the introduction tubular organ is facilitated. It can be carried out.
  • the introduction assisting instrument 11 is provided with the side hole 27, and the medical instrument 21 inserted into the tubular body 13 from the instrument body 15 can be extended to the outside from the side hole 27. Therefore, it is not necessary to extend the medical device 21 from the tip of the tubular body 13. Therefore, as shown in FIG. 1, the distal end portion of the tubular body 13 of the introduction assisting device 11 is allowed to pass through the guidewire for the introduction assisting device for guiding the introduction assisting device 11 in the introduction tubular organ. You may connect the front-end
  • the diameter of the tip opening of the through hole of the tip member 31 is determined so as to allow the passage of the guide wire for the introduction assisting device to the minimum, intrusion of body fluid or the like into the tubular body 13 of the introduction assisting device 11 Can be suppressed.
  • the distal end portion of the tubular body 13 of the introduction assisting device 11 is located in the introduction tubular organ and the side hole 27 is located outside the introduction tubular organ, the distal end of the tubular body 13 enters the tubular body 13. For example, there is an effect of suppressing body fluid from entering and flowing back to the outside of the introduction tubular organ through the side hole 27.
  • distal end member 31 is formed so that the outer peripheral surface has a tapered shape as it goes toward the distal end side, insertion of the introduced tubular organ through the puncture hole or the like and expansion of the puncture hole or the like can be performed. Has the effect of facilitating.
  • a guide wire (not shown) for an introduction assisting instrument is inserted into the introduction tubular organ using a puncture needle until the tip reaches the vicinity of the entrance of the side branch tubular organ in the introduction tubular organ.
  • the proximal end portion of the guide wire for the introduction assisting device is inserted into the tubular body 13 through the through hole of the tip member 31 connected to the distal end (distal end portion) of the introduction assisting device 11, thereby introducing the introduction assisting device.
  • the tubular body 13 of the introduction assisting device 11 is inserted into the introduction tubular organ along the guide wire.
  • the introduction assisting device 11 When the introduction assisting device 11 is placed in the introduction tubular organ so that the side hole 27 of the tubular body 13 is positioned in the vicinity of the entrance of the side branch tubular organ branched from the introduction tubular organ, a guide wire for the introduction assisting device is transferred from the introduction assisting device 11. Remove. Since a backflow prevention valve and a three-way switching valve are provided at the proximal end of the instrument body 15 of the introduction assisting instrument 11 and the free end of the connection tube 17, the side hole 27 of the tubular body 13 is inserted into the introduction tubular organ.
  • the introduction assisting instrument 11 Even if the introduction assisting instrument 11 is left in the introduced tubular organ in the state where it has been placed, the blood that has entered the lumen of the tubular body 13 from the side hole 27 can be prevented from flowing out of the body.
  • the diameter of the tip opening of the through hole of the tip member 31 is determined so as to have a minimum size that allows the guide wire for the introduction aid to pass, the introduction aid can be inserted when the introduction aid 11 is inserted. Even when the distal end portion of the 11 tubular body 13 is located in the introduction tubular organ while the side hole 27 is located outside the introduction tubular organ, the body fluid enters the tubular body 13 from the distal end portion of the tubular body 13. It is possible to suppress intrusion and backflow out of the introduction tubular organ through the side hole 27.
  • the side hole 27 provided in the tubular body 13 may be disposed at the entrance of the side branch tubular organ, and the distal end of the tubular body 13 is directed to the entrance of the side branch tubular organ. There is no need. Therefore, it is possible to prevent the entrance of the side branch tubular organ from being damaged by the distal end of the tubular organ 13.
  • the tubular body 13 includes a rigid portion 25 having rigidity higher than that of the main body portion 23.
  • the flexibility is enhanced by a plurality of slits 29 provided in the rigid portion 25 extending in the transverse direction.
  • the tubular body 13 can be flexibly deformed according to the shape of the tubular organ, and the operation of inserting the tubular body into the introduced tubular organ is facilitated.
  • the side hole 27 is provided in the rigid portion 25 having higher rigidity than the main body portion 23 of the tubular body 13, the strength reduction due to the removal of the side wall accompanying the formation of the side hole causes the rigidity of the material forming the rigid portion 25. And the occurrence of crushing and kinking in the portion where the side hole 27 is formed is reduced. Therefore, it is possible to avoid the passage of the medical instrument due to crushing or kinking.
  • a guide wire for a therapeutic instrument as a medical instrument 21 is passed through a backflow prevention valve (not shown) provided at the proximal end of the instrument main body 15 of the introduction assisting instrument 11 inside the tubular body 13 of the introducing assisting instrument 11. It is inserted into the passage and extends from the side hole 27 toward the entrance of the side branch tubular organ, and further pushed forward until the tip exceeds the lesion site.
  • the proximal end portion of the guide wire for the treatment instrument is inserted into the distal end of the treatment instrument as another medical instrument 21, and introduction assistance is performed through the backflow prevention valve provided at the proximal end portion of the instrument body 15 of the introduction assisting instrument 11.
  • the therapeutic instrument is inserted into the tubular body 13 of the instrument 11. Further, along the guide wire for the therapeutic instrument, the therapeutic instrument is pushed forward in the tubular body 13 of the introduction assisting instrument 11 and introduced into the side branch tubular organ through the side hole 27 to treat the lesion site.
  • FIG. 6 shows the rigid portion 25 ′ of the second embodiment of the introduction aid 11.
  • the rigid portion 25 ′ of the second embodiment is different from the slit 29 extending in the transverse direction in that a plurality of slits 33 extending in the longitudinal direction of the tubular body 13 are provided at both ends of the rigid portion 25 ′.
  • the second embodiment is different from the rigid portion 25 of the first embodiment, and has the same configuration as the rigid portion 25 of the first embodiment in other points. Accordingly, here, a description will be given mainly of the configuration different from the rigid portion 25 of the first embodiment, and description of the common configuration will be omitted.
  • a plurality of slits 33 extending in the longitudinal direction of the tubular body 13 are spaced apart from each other in the circumferential direction at both ends of the rigid portion 25 ′. Is formed. Further, each of both end portions of the rigid portion 25 ′ and the end portion of the main body portion 23 are connected and fixed in a state where one is inserted into the other. In the embodiment shown in FIG. Each end of 'is connected and fixed in a state of being inserted into the main body portion 23.
  • both ends of the rigid portion 25 of the first embodiment and the end of the main body portion 23 are connected and fixed in a state where one is inserted into the other, the main body portion 23 suddenly moves to the rigid portion 25. Since the stiffness changes, when the tubular body 13 is bent, bending may occur at the boundary between the main body portion 23 and the rigid portion 25, and the main body portion 23 may be damaged.
  • slits 33 extending in the longitudinal direction of the tubular body 13 are provided at both ends of the rigid portion 25 ′ connected to the flexible main body portion 23.
  • the slit 33 is preferably tapered toward the center in the longitudinal direction of the rigid portion 25 'so that the rigidity gradually changes in the intermediate rigid portion.
  • the slit 33 also has an effect of imparting flexibility to the rigid portion 25 ′ so that it can be flexibly deformed in accordance with the curvature of the introduction tubular conduit. Therefore, when the slit 33 is provided, it is possible to easily perform the operation of inserting the tubular body 13 into the introduction tubular organ without providing the transverse slit 29.
  • the rigid portion 25 has a substantially straight pipe shape, but the shape of the rigid portion 25 is not limited, as shown in FIG. It is also possible to form the tubular body 13 so as to have a curved shape in accordance with the shape of the distal end portion.

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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)

Abstract

L'instrument d'aide à l'introduction (11) de l'invention est équipé d'un corps tubulaire (13) inséré à l'intérieur d'un organe tubulaire du corps humain. Un trou latéral (27) est agencé dans une paroi périphérique du corps tubulaire (13), et un instrument médical (21) peut être introduit via ce trou latéral (27) du corps tubulaire (13), à l'intérieur de l'organe tubulaire. Le corps tubulaire (13) contient une portion corps principal (23) flexible, et une portion rigide (25) agencée dans une partie intermédiaire de la portion corps principal (23) et dont la rigidité est supérieure à celle de cette dernière. Des fentes (29) sont formées dans la paroi périphérique de la portion rigide (25) de manière à conférer à cette dernière une flexibilité.
PCT/JP2015/072071 2014-08-05 2015-08-04 Instrument d'aide à l'introduction avec trou latéral WO2016021592A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014159909A JP2016036394A (ja) 2014-08-05 2014-08-05 側孔付き導入補助器具
JP2014-159909 2014-08-05

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WO2016021592A1 true WO2016021592A1 (fr) 2016-02-11

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6058169A (ja) * 1983-06-14 1985-04-04 トマス・ジエイ・フオガテイ− カテ−テル偏向案内装置及び方法
JPH06277296A (ja) * 1993-01-26 1994-10-04 Terumo Corp 血管拡張器具およびカテーテル
JP2008132332A (ja) * 2006-11-28 2008-06-12 Cathrx Ltd カテーテル操作システム
JP2009142357A (ja) * 2007-12-12 2009-07-02 Piolax Medical Device:Kk 体内留置カテーテル
JP2012531270A (ja) * 2009-06-24 2012-12-10 シファメド・ホールディングス・エルエルシー 操作可能な医療用送達装置および使用方法
WO2015022972A1 (fr) * 2013-08-13 2015-02-19 株式会社カテラ Instrument d'aide à l'introduction avec trou latéral

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6058169A (ja) * 1983-06-14 1985-04-04 トマス・ジエイ・フオガテイ− カテ−テル偏向案内装置及び方法
JPH06277296A (ja) * 1993-01-26 1994-10-04 Terumo Corp 血管拡張器具およびカテーテル
JP2008132332A (ja) * 2006-11-28 2008-06-12 Cathrx Ltd カテーテル操作システム
JP2009142357A (ja) * 2007-12-12 2009-07-02 Piolax Medical Device:Kk 体内留置カテーテル
JP2012531270A (ja) * 2009-06-24 2012-12-10 シファメド・ホールディングス・エルエルシー 操作可能な医療用送達装置および使用方法
WO2015022972A1 (fr) * 2013-08-13 2015-02-19 株式会社カテラ Instrument d'aide à l'introduction avec trou latéral

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