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WO2023087477A1 - Gaine à courbure réglable - Google Patents

Gaine à courbure réglable Download PDF

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Publication number
WO2023087477A1
WO2023087477A1 PCT/CN2021/139706 CN2021139706W WO2023087477A1 WO 2023087477 A1 WO2023087477 A1 WO 2023087477A1 CN 2021139706 W CN2021139706 W CN 2021139706W WO 2023087477 A1 WO2023087477 A1 WO 2023087477A1
Authority
WO
WIPO (PCT)
Prior art keywords
pipe section
bending
bend
section
perfusion
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2021/139706
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English (en)
Chinese (zh)
Inventor
刘载淳
黄定国
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Tendfo Medical Technologies Co Ltd
Original Assignee
Shanghai Tendfo Medical Technologies Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202111363625.0A external-priority patent/CN113908404A/zh
Priority claimed from CN202122816592.2U external-priority patent/CN216824432U/zh
Application filed by Shanghai Tendfo Medical Technologies Co Ltd filed Critical Shanghai Tendfo Medical Technologies Co Ltd
Publication of WO2023087477A1 publication Critical patent/WO2023087477A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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

Definitions

  • the present application relates to the technical field of medical devices, in particular to an adjustable curved sheath.
  • Medical sheaths are used in minimally invasive interventional diagnostic and therapeutic operations to establish channels, transport or recover instruments, input drugs or export body fluids, etc. During the clinical process, according to actual needs and differences in the anatomical shape of the target vessel, the sheath needs to be adjusted to different shapes.
  • the purpose of some embodiments of the present application is to provide an adjustable bendable sheath to solve the problems of complicated structure and poor bending effect of the existing adjustable bendable sheath.
  • An embodiment of the present application provides an adjustable bending sheath, comprising: a support pipe section and a bending adjustment pipe section sequentially connected from the proximal end to the distal end; the support pipe section and the bending adjustment pipe section are provided with the support The proximal end of the pipe section runs through several perfusion channels at the distal end of the bend-adjusting pipe section, and the proximal end of the perfusion channel is open and the distal end is closed;
  • At least part of the bend-adjusting pipe section has elastic deformation capability, and the bending shape of the bend-adjusting pipe section can be controlled by adjusting the fluid pressure in the perfusion channel.
  • the bend-adjusting pipe section includes: a flexible end pipe section, the proximal end of which is connected to the distal end of the support pipe section; wherein, each perfusion channel in the flexible end pipe section corresponds to each perfusion channel in the support pipe section connected; or
  • the bend adjustment pipe section includes: an intermediate bend adjustment pipe section and a flexible end pipe section sequentially connected from the proximal end to the distal end, the proximal end of the intermediate adjustment bend pipe section is connected to the distal end of the support pipe section; wherein,
  • the intermediate bending section includes an intermediate bending unit or a plurality of end-to-end intermediate bending units; each of the intermediate bending units includes a flexible sub-section and a rigid sub-section sequentially connected from the proximal end to the distal end ; Wherein, the respective perfusion channels of the support pipe section, the intermediate bend pipe section and the flexible end pipe section are correspondingly communicated.
  • the perfusion channel of the mid-adjustment elbow section adopts a straight perfusion channel extending along its own axial direction from the proximal end to the distal end with the centerline parallel to the centerline of the mid-adjustment elbow section, and the flexible end
  • the perfusion channel of the pipe segment is arranged in a helical structure along its own axial direction from the proximal end to the distal end.
  • the bend-adjusting pipe section includes a plurality of flexible bend-adjusting pipe sections sequentially connected from the proximal end to the distal end;
  • a plurality of perfusion channels are respectively provided from the proximal end of the support pipe section to the distal side of each flexible bend-adjusting pipe section, so as to adjust the bend of each flexible bend-adjusting pipe section respectively.
  • the perfusion channel of the bend-adjusting pipe section includes:
  • a helical perfusion channel extending in a helical structure around the center of the bend-adjusting pipe segment along the direction from the proximal end to the distal end of the bend-adjusting pipe segment.
  • the perfusion channel of the support tube segment is a straight perfusion channel extending along the direction from the proximal end to the distal end of the support tube segment with a center line parallel to its own center line.
  • the perfusion channels of the support pipe section and the bend-adjusting pipe section are multiple and communicated one by one, and the multiple perfusion channels are evenly spaced in the circumferential direction.
  • the number of perfusion channels of the bend-adjusting pipe segment is greater than the number of perfusion channels of the support pipe segment, and at least one perfusion channel of the support pipe segment communicates with multiple perfusion channels of the bend-adjusting pipe segment.
  • the adjustable bending sheath also includes a developing marking point arranged on the outer periphery of the bending adjustment tube section;
  • the development mark points include: a proximal development point arranged at the proximal side of the bending adjustment tube section and/or a distal development point set at the far end of the bending adjustment tube section.
  • the flexible end pipe section and the flexible sub-pipe section are made of one or more of the following materials: nylon, nylon elastomer, thermoplastic polyurethane elastomer, silica gel or latex;
  • the supporting pipe section and the rigid sub-pipe section are made of one or more of the following materials: nylon, nylon elastomer or polyetheretherketone.
  • the adjustable bending sheath of the embodiment of the present application uses the principle of bionics to make the bending adjustment pipe section elastically deformable, and at the same time, by adjusting the fluid pressure in the perfusion channel of the bending adjustment pipe section, the bending shape of the bending adjustment pipe section can be controlled, and the bending shape of the bending adjustment pipe section can be adjusted.
  • the bend is highly operable, which is conducive to making the sheath closer to the natural vascular bending shape, so as to better conform to the different bending shapes of the blood vessel for pushing.
  • the sheath has a simple structure and a simple and convenient manufacturing process, which is beneficial to clinical popularization and use.
  • FIG. 1 is a schematic structural view of an adjustable curved sheath provided in an embodiment of the present application
  • Fig. 2 is a partial structural schematic diagram of the support tube section of the adjustable curved sheath provided in the embodiment of the present application;
  • Fig. 3 is a schematic diagram of a partial structure of the bend-adjusting tube section of the adjustable bend sheath provided in the embodiment of the present application.
  • proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end.
  • Control adjustable curved sheath Unless otherwise specified, the proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Control adjustable curved sheath.
  • an adjustable curved sheath provided in the embodiment of the present application can cooperate with an injection device to produce different curved shapes, so as to facilitate pushing in blood vessels with different curved shapes.
  • the adjustable bending sheath of the embodiment of the present application mainly includes: a support tube section 1 and a bending tube section 2 connected in sequence from the proximal end to the distal end.
  • the support pipe section 1 and the bend-adjusting pipe section 2 are provided with several perfusion channels that run through from the proximal end of the support pipe section 1 to the distal end of the bend-adjusting pipe section 2.
  • the proximal end of the perfusion channel is open and the distal end is closed.
  • the support pipe section 1 has a perfusion channel 11 thereon
  • the bend-adjusting pipe section 2 has a perfusion channel 21 thereon, and the perfusion channel 11 of the support pipe section 1 and the perfusion channel 21 of the bend-adjustment pipe section 2 communicate to form an adjustable bending sheath perfusion channel.
  • a perfusion device such as a syringe
  • Connecting a perfusion device through the proximal opening of the perfusion channel can inject fluid (liquid or gas) into the perfusion channel, thereby controlling the fluid pressure in the perfusion channel, so that the tube body of the bending tube section 2 is subjected to different degrees of fluid pressure Therefore, directional bending can be performed on the bending-adjusting pipe section 2, and the stimulation to blood vessels is gentler.
  • At least part of the bend-adjusting pipe section 2 has elastic deformation capability, and the bending shape of the bend-adjusting pipe section 2 can be controlled by adjusting the fluid pressure in the perfusion channel.
  • the bend-adjusting pipe section 2 can be made of materials with elastic deformation capacity. In the natural state, the bend-adjusting pipe section 2 is in the shape of a straight pipe.
  • the segment 2 can be elastically deformed under the action of fluid pressure to produce a controllable bending shape, so that the bending shape of the bending adjustment pipe segment 2 can be controlled by designing the direction of the perfusion channel and its combination.
  • the perfusion channel can be opened in the tube walls of the support tube section 1 and the bend-adjusting tube section 2 and runs through the proximal and distal ends of the adjustable curved sheath tube body, and a blind hole with a closed distal end. Utilizing the perfusion channel structure in the tube body of the adjustable bendable sheath for bending adjustment does not occupy the space of the perfusion channel in the adjustable bendable sheath, reduces the space requirement in the bending adjustment process, and is more conducive to passing through tortuous blood vessels. In some examples, the perfusion channel may also protrude beyond the wall of the adjustable bend sheath.
  • the bend-adjusting pipe section 2 may include: an intermediate bend-adjusting pipe section and a flexible end pipe section 27 sequentially connected from the proximal end to the distal end.
  • the proximal end of the middle-adjustment bent pipe section is connected with the distal end of the support pipe section 1 .
  • the intermediate bending pipe section includes an intermediate bending unit.
  • the intermediate bending unit includes a flexible sub-pipe section 25 and a rigid sub-pipe section 26 sequentially connected from the proximal end to the distal end.
  • the perfusion channel 11 of the supporting pipe section 1 and the perfusion channel 21 of the bending adjustment pipe section 2 correspond to each other, that is, a through-flow can be formed. Bend the proximal to distal perfusion channel of the sheath.
  • the flexible tip tube segment 27 may have a frusto-conical tip to facilitate intravascular advancement.
  • the bending pipe section is divided into multiple flexible pipe sections through rigid sub-sections, which facilitates segmental bending adjustment of the bending pipe section 2 .
  • the flexible sub-pipe section 25 and the flexible end pipe section 27 are spaced apart by the rigid sub-pipe section 26, so that the flexible sub-pipe section 25 and the flexible end pipe section 27 can be adjusted for bending.
  • the middle rigid sub-pipe section 26 is similar to the supporting pipe section 1 and maintains its original shape, so that the pipe section can be adjusted 2 segmented bend adjustment.
  • the intermediate bending pipe section may further include a plurality of intermediate bending units.
  • Each intermediate bending unit includes flexible sub-sections 25 and rigid sub-sections 26 that are sequentially connected from the proximal end to the distal end, and each intermediate bending unit is connected end to end. connected, so that the bending adjustment pipe section 2 can be finely divided into a plurality of adjustable bending pipe sections that can be adjusted in sections according to actual needs, which can facilitate accurate bending adjustment according to actual needs.
  • each flexible tube segment can be bent, so that the sheath tube has more bending joints, which can greatly improve the space adjustment operation degree during the bending adjustment process and improve the bending operation performance.
  • the bend-adjusting pipe section 2 may comprise a plurality of flexible bend-adjusting pipe sections sequentially connected from the proximal end to the distal end. A number of perfusion channels are respectively provided from the proximal end of the support pipe section 1 to the distal side of each flexible bend-adjusting pipe section, so as to adjust the bend of each flexible bend-adjusting pipe section respectively.
  • the bend-adjusting pipe section 2 may include two flexible bend-adjusting pipe sections, such as a proximal bend-adjusting section connected to the support pipe section and a terminal bend-adjusting section connected to the distal end of the proximal-end bend-adjusting section.
  • the perfusion channel of the adjustable bending sheath can include a plurality of perfusion channels through the support tube section and the distal end of the proximal bending section, and a plurality of perfusion channels through the support tube section to the distal end of the terminal bending section, so that through the proximal
  • the respective perfusion channels of the bend adjustment section and the end bend adjustment section are adjusted for bending, so that the entire bend adjustment pipe section can be adjusted for bending.
  • the perfusion channel of the bend-adjusting pipe section 2 may include: a straight perfusion channel extending along the centerline parallel to the centerline of the bend-adjusting pipe section 2 in the direction from the proximal end to the distal end of the bend-adjusting pipe section 2 and/or along the direction of the bend-adjusting pipe section 2
  • a helical perfusion channel extending around the center of the bend-adjusting pipe section 2 in a helical structure from the proximal end to the distal end of the pipe section 2 . That is, the perfusion channel on the bend adjusting pipe section 2 may extend parallel to the bend adjusting pipe section 2 and/or extend around the center of the bend adjusting pipe section 2 in a helical structure.
  • the bend-adjusting pipe section By pouring fluid into the straight perfusion channel of the bend-adjusting pipe section 2, the bend-adjusting pipe section can be bent in a plane. For example, when the straight perfusion channel is located on the left side of the bend-adjusting pipe section 2, the bend-adjusting pipe section can The pipe section is bent to the right, and vice versa, so as to facilitate adjustment of the bending shape of the pipe section 2 such as up, down, left, and right.
  • the bend-adjusting pipe section 2 can be spirally bent in three-dimensional space.
  • Various combinations of straight perfusion channels and spiral perfusion channels can be designed according to actual clinical needs.
  • the perfusion channel of the support tube segment 1 is a straight perfusion channel extending along the proximal end to the distal end of the support tube segment 1 with the center line parallel to its own center line. Due to its own rigidity, the support pipe section 1 will not be bent and deformed with the change of the pressure in the channel, so that it can be pushed near the end.
  • the perfusion channels of the support pipe section 1 and the bend adjustment pipe section 2 are multiple and communicated one by one, and the multiple perfusion channels are evenly spaced in the circumferential direction, so that it is convenient to adjust the bend of the bend adjustment pipe section 2 from various angles. improve its versatility. It can be understood that the number of perfusion channels of the bend adjustment pipe section can be greater than the number of perfusion channels of the support pipe section 1, at this time, at least one perfusion channel of the support pipe section 1 communicates with multiple perfusion channels of the bend adjustment pipe section 2.
  • the support pipe section 1 has 4 perfusion channels
  • the bend adjustment pipe section 2 has 6 perfusion channels
  • the two perfusion channels on the upper side and the left side of the support pipe section 1 are respectively connected to the two same-side perfusion channels of the bend adjustment pipe section 2 , so that it is beneficial to make the bending shape of the bending adjustment pipe section 2 more controlled.
  • the perfusion channel of the mid-adjustment elbow section adopts a straight perfusion channel extending along its own axis from the proximal end to the distal end with the centerline parallel to the centerline of the mid-adjustment elbow section, and the perfusion of the flexible end tube section
  • the channel is arranged in a spiral structure from the proximal end to the distal end along its own axial direction, and each straight perfusion channel of the intermediate bend pipe section is connected with a straight perfusion channel of the support pipe section 1 and a helical perfusion channel of the flexible end pipe section 27 respectively.
  • the intermediate bend pipe section includes a flexible sub-pipe section 25 , a rigid sub-pipe section 26 and a flexible end pipe section 27 .
  • the perfusion channels of the flexible sub-pipe section 25 and the rigid sub-pipe section 26 are straight perfusion channels, while the perfusion channels of the flexible end tube section 27 are spiral perfusion channels, and the number of straight perfusion channels is 4, uniformly distributed along the circumferential direction, spiral
  • the number of perfusion channels is also four, two of which are forward helical structures and two are reverse helical structures, and the four helical perfusion channels are uniformly distributed in the circumferential direction. Therefore, the flexible sub-pipe section 25 can be controlled to bend in four directions such as up, down, left, and right, and at the same time, the flexible end pipe section 27 can be controlled to bend in a forward or reverse direction.
  • the cross-sectional shape and size of the perfusion channel of the support pipe section 1 can be the same as the cross-sectional shape and size of the perfusion channel of the bend-adjusting pipe section 2, that is, the cross-sectional area of the perfusion channel of the support pipe section 1 is the same as that of the bend-adjusting pipe section 2.
  • the perfusion channels have the same cross-sectional area.
  • the cross-sectional area of the perfusion channel of the supporting pipe section 1 may also be larger than that of the perfusion channel of the bend-adjusting pipe section 2, which can facilitate the increase of the perfusion speed.
  • the adjustable bending sheath can also include a developing marking point arranged on the outer periphery of the bending adjusting tube section 2 .
  • the development marking points may include: a proximal development point 23 disposed on the proximal side of the bend adjustment tube section 2 and/or a distal development point 24 disposed on the far end of the bend adjustment pipe segment 2 .
  • the near-end developing point 23 can prompt the starting position of the bend-adjusting pipe section 2, and the distal developing point 24 can prompt the end position of the bend-adjusting pipe section 2.
  • the developing solution can also be injected into the perfusion channel, and the bending form of the entire bending adjustment pipe section can be indicated by the developing solution.
  • the rigid pipe sections such as the support pipe section 1 and the rigid sub-pipe section 26 can be made of high-hardness polymer materials or braided composite materials, including but not limited to one or more of the following materials: nylon (Polyamide , referred to as PA), nylon elastomer (Arkema's Pebax) or polyetheretherketone (Poly-ether-ether-Ketone, referred to as PEEK).
  • nylon Polyamide
  • PA nylon elastomer
  • PEEK polyetheretherketone
  • Flexible pipe sections such as the flexible end pipe section 27 and the flexible sub-pipe section 25 can be made of low-hardness polymer materials or elastomer materials, including but not limited to one or more of the following materials: nylon, nylon elastomer, thermoplastic Polyurethane elastomer (Thermoplastic Urethane, TPU for short), silicone or latex.
  • nylon nylon elastomer
  • thermoplastic Polyurethane elastomer Thermoplastic Urethane, TPU for short
  • silicone or latex There is no specific limitation here, as long as the required rigidity and elastic deformation ability can be satisfied.
  • the support pipe section 1 and the bend adjustment pipe section 2 can be processed into one piece, and at the same time, it is sufficient to ensure that the respective perfusion channels of the support pipe section 1 and the bend adjustment pipe section 2 are coaxially matched and communicated.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the bending adjustment tube section has elastic deformation ability, and the bending shape of the bending adjustment tube section can be controlled by adjusting the fluid pressure in the perfusion channel of the bending adjustment tube section, and the bending adjustment is highly operable , It is beneficial to make the sheath tube closer to the bending shape of the natural blood vessel, so as to better conform to the different bending shapes of the blood vessel for pushing.
  • the sheath has a simple structure and a simple and convenient manufacturing process, which is beneficial to clinical popularization and use.

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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

Une gaine à courbure réglable, comprenant une section de support (1) et une section de réglage de courbure (2) reliées de manière séquentielle d'une extrémité proximale à une extrémité distale. La section de support (1) et la section de réglage de courbure (2) sont pourvues d'une pluralité de canaux de perfusion s'étendant à travers l'extrémité proximale de la section de support (1) à l'extrémité distale de la section de réglage de courbure (2), et les canaux de perfusion ont les extrémités proximales ouvertes et les extrémités distales fermées. Au moins une partie de la section de réglage de courbure (2) a une capacité de déformation élastique, et la forme de courbure de la section de réglage de courbure (2) peut être régulée par réglage de la pression de fluide dans les canaux de perfusion. La forme de courbure de la section de réglage de courbure (2) est régulée au moyen de la pression de fluide dans les canaux de perfusion, et, par conséquent, il est avantageux d'améliorer la contrôlabilité de la forme de courbure ; de plus, la structure est simple, l'opération est facile, et les canaux de perfusion de la gaine ne sont pas occupés.
PCT/CN2021/139706 2021-11-17 2021-12-20 Gaine à courbure réglable Ceased WO2023087477A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202122816592.2 2021-11-17
CN202111363625.0A CN113908404A (zh) 2021-11-17 2021-11-17 一种可调弯鞘管
CN202122816592.2U CN216824432U (zh) 2021-11-17 2021-11-17 一种可调弯鞘管
CN202111363625.0 2021-11-17

Publications (1)

Publication Number Publication Date
WO2023087477A1 true WO2023087477A1 (fr) 2023-05-25

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PCT/CN2021/139706 Ceased WO2023087477A1 (fr) 2021-11-17 2021-12-20 Gaine à courbure réglable

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WO (1) WO2023087477A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120402117A (zh) * 2025-07-04 2025-08-01 中铁十九局集团有限公司 隧道注浆装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4890602A (en) * 1987-11-25 1990-01-02 Hake Lawrence W Endoscope construction with means for controlling rigidity and curvature of flexible endoscope tube
US20040186378A1 (en) * 2003-03-21 2004-09-23 Douglas Gesswein Articulating guide catheter
CN101448540A (zh) * 2006-01-06 2009-06-03 科迪斯公司 用于输送医用有效负载的医用输送系统
CN103402577A (zh) * 2011-03-01 2013-11-20 萨诺瓦斯股份有限公司 可操控的导管
CN112515731A (zh) * 2019-09-19 2021-03-19 杭州唯强医疗科技有限公司 分段式可调弯微导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4890602A (en) * 1987-11-25 1990-01-02 Hake Lawrence W Endoscope construction with means for controlling rigidity and curvature of flexible endoscope tube
US20040186378A1 (en) * 2003-03-21 2004-09-23 Douglas Gesswein Articulating guide catheter
CN101448540A (zh) * 2006-01-06 2009-06-03 科迪斯公司 用于输送医用有效负载的医用输送系统
CN103402577A (zh) * 2011-03-01 2013-11-20 萨诺瓦斯股份有限公司 可操控的导管
CN112515731A (zh) * 2019-09-19 2021-03-19 杭州唯强医疗科技有限公司 分段式可调弯微导管

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120402117A (zh) * 2025-07-04 2025-08-01 中铁十九局集团有限公司 隧道注浆装置

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