WO2020208961A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet Download PDF

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Publication number
WO2020208961A1
WO2020208961A1 PCT/JP2020/007649 JP2020007649W WO2020208961A1 WO 2020208961 A1 WO2020208961 A1 WO 2020208961A1 JP 2020007649 W JP2020007649 W JP 2020007649W WO 2020208961 A1 WO2020208961 A1 WO 2020208961A1
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WO
WIPO (PCT)
Prior art keywords
balloon
balloon catheter
outer tube
telescopic portion
inner tube
Prior art date
Application number
PCT/JP2020/007649
Other languages
English (en)
Japanese (ja)
Inventor
康宏 村木
隆明 矢吹
貴宏 羽田
孝志 粂野
Original Assignee
株式会社東海メディカルプロダクツ
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 株式会社東海メディカルプロダクツ filed Critical 株式会社東海メディカルプロダクツ
Publication of WO2020208961A1 publication Critical patent/WO2020208961A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon catheter.
  • the removable diameter may be larger than the insertable diameter.
  • a typical example is a balloon catheter used in the aorta, one for touch-up that mainly aims to crimp the inner wall of the blood vessel of the stent graft placed in the aorta, and the other that occludes the inside of the blood vessel and controls blood flow. Occlusion (for occlusion) and balloon catheters for IAB are known.
  • balloon catheters for stent graft expansion and balloon catheters for occlusion used in the aorta it is necessary to greatly expand the balloon in order to make a wide range of contact so that the balloon adheres to the inner wall in the blood vessel or in the stent graft.
  • a balloon having a large expansion diameter and a large injection capacity of an expansion medium is used as compared with other balloon catheters for endovascular treatment.
  • the balloon is generally made of a highly extensible material, the balloon membrane is also formed as thin as possible, and it is folded thin to improve the sheath passage during insertion. I am using the one that is wrapped.
  • a balloon catheter may be inserted directly into the blood vessel without a sheath. Even in this case, there is a problem that it is difficult to pull out the balloon when it is pulled out once the balloon that has been expanded and contracted becomes large.
  • the balloon in order to bring the balloon into close contact with the inner wall inside the blood vessel or stent, it may expand (over-expand) far beyond the volume (standard diameter) at the time of molding the balloon.
  • the membrane of the balloon may be inverted at the joint with the inner tube and the outer tube and may overlap with the tubular portion of the distal portion and the proximal portion (see FIG. 5).
  • IAB is left in the body for a long period of time, so a thin sheath is desired so as not to interfere with peripheral blood circulation.
  • the thickness of the balloon is made as thick as possible due to durability issues. Therefore, the balloon is neatly wrapped to allow it to pass through the sheath before insertion. After use, the balloon is inflated and cannot be folded neatly inside the body, making it difficult to pass through the sheath, which is also usually removed with the sheath.
  • a sheath larger than the insertable size must be selected before use, but even in that case, the resistance when passing through the sheath is large, especially.
  • the balloon length was long, the resistance in the sheath increased, and the balloon was gradually stretched and biased to the distal side, which sometimes made it difficult to remove.
  • the stainless rod inserted into the catheter tube is joined to the distal side of the balloon, and the outer tube is joined to the proximal side of the balloon, so that the stainless rod slides and contracts when the balloon is extended.
  • a balloon catheter has been proposed in which wrinkles are smoothed by increasing the diameter and the passage through the sheath is improved (Patent Document 1).
  • such a balloon catheter has a structure in which the inner tube and the outer tube are not fixed, the inner tube penetrates the outer tube, and the inner tube can freely rotate with respect to the outer tube.
  • the balloon can be easily wound by rotating it, but it is necessary to establish an inner tube that penetrates the outer tube, fix the inner tube when the balloon is expanded, and prevent leakage of the expansion medium. Therefore, there is a problem that the structure becomes complicated and the manufacturing process becomes complicated. Further, there is a problem that it is necessary to adjust the fixed position of the inner according to the work during the treatment.
  • an object of the present invention is to provide a balloon catheter capable of easily storing a balloon catheter expanded in the body in a thin sheath. And.
  • the present invention has adopted the following means in order to achieve the above-mentioned object.
  • the balloon catheter according to the present invention It has a long shaft consisting of an inner tube and an outer tube, and a balloon.
  • the balloon has a distal end directly or indirectly joined to the inner tube and a proximal end directly or indirectly joined to the outer tube to form between the inner tube and the outer tube.
  • the outer pipe is characterized by having an expansion / contraction portion between the outer pipe and the hand side so that the outer pipe can be moved in the axial direction with respect to the inner pipe.
  • the inner tube connected to the distal end of the balloon and the inner tube connected to the proximal end of the balloon can be moved in the axial direction, so that the proximal part of the balloon can be moved.
  • the distance between the ends and the distal ends can be changed. Therefore, when the balloon is contracted to be housed in the sheath, the user can compress the elastic part at hand to stretch the balloon and remove wrinkles, and improve the passageability with a thin sheath. .. That is, it can be contracted thinner, and the balloon can be stored in a thinner sheath.
  • the telescopic portion may be characterized by having a bellows structure, a Miura fold structure or a spiral structure.
  • the outer pipe can be efficiently moved with respect to the inner pipe.
  • the telescopic portion may be characterized by including a spring member that assists the expansion and contraction.
  • the outer tube can be urged in a certain direction, so that the distance between the proximal end and the distal end of the balloon catheter can be adjusted by operating only in one direction.
  • the telescopic portion may be characterized by including a stopper for holding the stretched state.
  • the distance between the distal end and the proximal end of the balloon can be fixed at a constant distance, so that a balloon catheter that is easier to use can be obtained.
  • the telescopic portion may be arranged on the outer peripheral side of the outer tube.
  • the telescopic portion may be characterized by having a tapered shape in the axial direction.
  • either the distal end or the proximal end can be made thicker, so that the elastic part can be easily operated.
  • the balloon catheter according to the present invention may be characterized in that a connector is provided at the proximal end of the shaft, and the telescopic portion is arranged adjacent to the connector.
  • the telescopic part will be placed near the connector, so it is easy to operate on the hand side and it is also possible to operate with one hand.
  • the balloon catheter according to the present invention when the balloon is contracted to be housed in the sheath, the user compresses the elastic part at hand to stretch the balloon to remove wrinkles, and the thin sheath is used. It is possible to provide a balloon catheter that can improve the passage.
  • FIG. 1 is a schematic view of the balloon catheter 100 according to the first embodiment.
  • FIG. 2 is a schematic view showing an example of the configuration of the telescopic portion 30 of the balloon catheter 100 according to the first embodiment.
  • FIG. 3 is a schematic view showing an example of the configuration of the telescopic portion 30 of the balloon catheter 100 according to the first embodiment.
  • FIG. 4 is a schematic view showing a state in which the telescopic portion 30 of the balloon catheter 100 according to the first embodiment is contracted.
  • FIG. 5 is a schematic view showing a state in which the balloon 20 is over-expanded.
  • FIG. 6 is a schematic view showing the telescopic portion 30 of the balloon catheter 100 according to the second embodiment.
  • FIG. 1 is a schematic view of the balloon catheter 100 according to the first embodiment.
  • FIG. 2 is a schematic view showing an example of the configuration of the telescopic portion 30 of the balloon catheter 100 according to the first embodiment.
  • FIG. 3 is a schematic view showing an example of the configuration of
  • FIG. 7 is a schematic view showing the telescopic portion 30 of the balloon catheter 100 according to the third embodiment.
  • FIG. 8 is a schematic view showing the telescopic portion 30 of the balloon catheter 100 according to the fourth embodiment.
  • FIG. 9 is a schematic view showing the telescopic portion 30 of the balloon catheter 100 according to the fifth embodiment.
  • the balloon catheter 100 according to the present invention will be described in detail with reference to the drawings.
  • the embodiments and drawings described below exemplify a part of the embodiments of the present invention, are not used for the purpose of limiting to these configurations, and do not deviate from the gist of the present invention. It can be changed as appropriate within the range.
  • the "distal end” and the “proximal end” refer to the hand side with respect to the balloon catheter 100 as the "proximal end", and the tip thereof. The side is called the "distal end”.
  • the balloon catheter 100 according to the first embodiment is mainly provided on a long shaft 10 including an inner tube 11 and an outer tube 12 and a distal end side of the shaft 10, as shown in FIGS. 1 and 2.
  • the balloon 20 and the telescopic portion 30 provided on the shaft 10 are provided.
  • the shaft 10 has a double pipe structure of an inner pipe 11 and an outer pipe 12, and the lumen 11a in the inner pipe 11 is mainly used for passing a guide wire, and is between the inner pipe 11 and the outer pipe 12.
  • the lumen 12a of the above is mainly used as a space for introducing an expansion fluid for expanding the balloon 20.
  • the inner tube 11 extends to the distal end side of the balloon 20 and is fluid-tightly joined to the distal end side of the balloon 20 either directly or indirectly via a ring near the distal end or the distal end. 11 is arranged in the balloon 20.
  • the outer tube 12 extends to the proximal end side of the balloon 20, and the distal end or the vicinity of the distal end of the outer tube 12 and the proximal end of the balloon 20 are joined directly or indirectly via a ring in a liquid-tight manner. Has been done.
  • the inner pipe 11 and the outer pipe 12 are provided so that their relative positions can be changed in the axial direction.
  • the inner tube 11 is made of a tubular resin, and examples thereof include high-density polyethylene, polyamide, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane, polypropylene, and fluororesin.
  • the outer tube 12 is also made of a tubular resin, and examples thereof include polyamide, polyethylene, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane and polypropylene.
  • the balloon 20 is formed of a resin-made film-like hollow body, and is formed to expand by pressure by supplying an expansion fluid composed of gas or liquid to the inside, and to be contractible by suction. ..
  • Examples of the material constituting the balloon 20 include polyamide, polyamide elastomer, polyethylene terephthalate, polyester elastomer, and polyurethane.
  • the telescopic portion 30 is attached to a part of the outer tube 12 of the balloon 20 as shown in FIG.
  • the telescopic portion 30 has a tubular body that is continuously formed so as to be sealed with respect to the outer tube 12, or a tapered shape in which either the distal end side or the proximal end side is formed thinner than the other. Is formed in. It is preferable to provide the telescopic portion 30 at a position within 10 cm from the hand side so that the telescopic portion 30 can be easily operated. By extending or contracting the telescopic portion 30 in the axial direction, the position of the outer pipe 12 on the distal end side of the telescopic portion 30 with respect to the inner pipe 11 can be moved in the axial direction.
  • the form of the telescopic portion 30 is not particularly limited as long as the position of the outer tube 12 on the distal end side of the telescopic portion 30 can be moved, but for example, as shown in FIG. 2A, the telescopic portion 30 is bellows by a plastic thin film. It may be formed into a structure, a spiral structure as shown in FIG. 2B, or a so-called Miura fold structure (including a PCCP shell structure) as shown in FIG.
  • the balloon catheter 100 produced in this manner has an inner tube 11 connected to the distal end of the balloon 20 and a proximal of the balloon 20 by making the telescopic portion 30 contract in the axial direction or in the stretched state. Since the axial relative position with respect to the outer tube 12 connected to the end can be changed, the distance between the distal end and the proximal end of the balloon 20 can be changed.
  • the balloon 20 when the balloon 20 is contracted, as shown in FIG. 5, the balloon 20 is excessively expanded beyond the overlap near the joint portion of the distal end or the proximal end of the balloon 20, and the balloon 20 is folded over the shaft 10. As shown in FIG. 4, the user compresses the telescopic portion 30 at hand even when the balloon 20 is stretched due to plastic deformation of the material of the balloon 20 to make it difficult to pass through the sheath.
  • the balloon 20 can be stretched to remove wrinkles and improve passage with a thin sheath.
  • FIG. 6A A partially enlarged view of the telescopic portion 30 of the balloon catheter 100 according to the second embodiment is shown in FIG. 6A.
  • the second embodiment is different from the first embodiment in that the telescopic portion 30 is provided with a spring member 60 that assists the expansion and contraction.
  • the operability can be improved because it is only necessary to apply a force in one direction to move the telescopic portion 30. That is, when the spring member 60 for maintaining the stretchable portion 30 in the stretched state is provided in advance, the force needs to be applied only when the stretchable portion 30 is contracted, and when returning to the original state, the hand is released from the stretchable portion 30. By doing so, it can be automatically returned to the initial state.
  • the spring member 60 When arranging the spring member 60 in the telescopic portion 30, as shown in FIG. 6B, a spiral shape is used for the telescopic portion 30, and the rotation pitch of the spring member 60 is set to the spiral pitch of the telescopic portion 30.
  • the spring member 60 can be inserted into the spiral fold portion, and the spring member 60 having a larger outer diameter can be arranged. With such a configuration, the possibility that the spring member 60 becomes a resistance when injecting the expansion fluid can be reduced.
  • FIG. 10 A partially enlarged view of the telescopic portion 30 of the balloon catheter 100 according to the third embodiment is shown in FIG. Since the configuration of the shaft 10 according to the third embodiment, the balloon 20 provided on the distal end side of the shaft 10, and the telescopic portion 30 provided on the shaft 10 is the same as that of the first embodiment, the description thereof will be omitted. To do.
  • the expansion / contraction portion 30 is provided with a stopper 70, and can be fixed at an arbitrary expansion / contraction ratio position according to the expansion / contraction state of the expansion / contraction portion 30.
  • a stopper 70 for example, as shown in FIG. 7, a clip or the like that holds both sides of the telescopic portion 30 and can adjust the distance between the holding portions on both sides to an arbitrary position can be considered.
  • FIG. 10 of the balloon catheter 100 according to the fourth embodiment and the balloon 20 provided on the distal end side of the shaft 10 are the same as those of the first embodiment, and thus the description thereof will be omitted.
  • the telescopic portion 30 is arranged on the outer peripheral side of the outer tube 12, the proximal end of the telescopic portion 30 is connected adjacent to the connector 90 on the hand side, and the distal end side is the outer side. It is connected to a tubular member 35 formed by tightening the pipe 12 with a constant frictional force. Although the tubular member 35 can be moved by human power, it is tightened to such an extent that it cannot be moved by normal balloon expansion and contraction operations, and has a function as a stopper.
  • a part of the outer tube 12 can enter the connector 90 by contracting the telescopic portion 30, and the relative position between the inner tube 11 and the outer tube 12 can be changed, and the balloon can be changed.
  • the distance between the distal and proximal ends of 20 can be adjusted.
  • FIG. 1 A partially enlarged view of the telescopic portion 30 of the balloon catheter 100 according to the fifth embodiment is shown in FIG. Since the balloon 20 related to the balloon catheter 100 according to the fifth embodiment is the same as that of the first embodiment, the description thereof will be omitted.
  • the outer tube 12 of the shaft 10 is formed by being divided into two at the telescopic portion 30, and one outer tube 12c is inserted inside the other outer tube 12b. It is formed like this.
  • the telescopic portion 30 can be arranged on the outer peripheral side of the outer pipe 12. Therefore, since the expansion fluid does not come into contact with the inner surface of the expansion / contraction portion 30, it is possible to prevent the flow of the fluid from being disturbed due to the unevenness of the inner surface of the expansion / contraction portion 30.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (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'invention concerne un cathéter à ballonnet de sorte que l'utilisateur peut comprimer une partie télescopique située sur un côté poignée pour étirer le ballonnet et éliminer des plis lors du dégonflage du ballonnet de façon à se loger dans une gaine, ce qui permet au cathéter à ballonnet de passer à travers des gaines minces plus facilement.　Le cathéter à ballonnet (100) selon la présente invention comprend un corps de cathéter long (10) qui comporte un tube interne (11), un tube externe (12) et un ballonnet (20) qui a une extrémité distale reliée au tube interne et une extrémité proximale reliée au tube externe et qui se gonfle et se dégonfle au moyen de la pression de fluide fournie dans le ballonnet par un espace formé entre le tube interne et le tube externe, ledit cathéter à ballonnet étant caractérisé en ce qu'il comprend une partie télescopique (30) entre le tube externe et le côté poignée pour permettre au tube externe d'être axialement mobile par rapport au tube interne.
PCT/JP2020/007649 2019-04-12 2020-02-26 Cathéter à ballonnet WO2020208961A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019076472A JP2020171601A (ja) 2019-04-12 2019-04-12 バルーンカテーテル
JP2019-076472 2019-04-12

Publications (1)

Publication Number Publication Date
WO2020208961A1 true WO2020208961A1 (fr) 2020-10-15

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PCT/JP2020/007649 WO2020208961A1 (fr) 2019-04-12 2020-02-26 Cathéter à ballonnet

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JP (1) JP2020171601A (fr)
WO (1) WO2020208961A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010533513A (ja) * 2007-07-13 2010-10-28 アボット カーディオバスキュラー システムズ インコーポレイテッド 薬剤被覆したバルーンカテーテル
JP2012502759A (ja) * 2008-09-22 2012-02-02 ボストン サイエンティフィック サイムド，インコーポレイテッド カテーテルバルーンの付勢

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010533513A (ja) * 2007-07-13 2010-10-28 アボット カーディオバスキュラー システムズ インコーポレイテッド 薬剤被覆したバルーンカテーテル
JP2012502759A (ja) * 2008-09-22 2012-02-02 ボストン サイエンティフィック サイムド，インコーポレイテッド カテーテルバルーンの付勢

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