WO2023179316A1 - 一种医用导管及*** - Google Patents

一种医用导管及*** Download PDF

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Publication number
WO2023179316A1
WO2023179316A1 PCT/CN2023/078480 CN2023078480W WO2023179316A1 WO 2023179316 A1 WO2023179316 A1 WO 2023179316A1 CN 2023078480 W CN2023078480 W CN 2023078480W WO 2023179316 A1 WO2023179316 A1 WO 2023179316A1
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WO
WIPO (PCT)
Prior art keywords
tube body
medical catheter
proximal
distal end
inner cavity
Prior art date
Application number
PCT/CN2023/078480
Other languages
English (en)
French (fr)
Inventor
包俊伟
何志华
甘耀�
Original Assignee
深圳微创踪影医疗装备有限公司
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Publication of WO2023179316A1 publication Critical patent/WO2023179316A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0891—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a medical catheter and system.
  • IVUS Intravascular ultrasound tomography
  • IVUS uses catheter technology to place a miniaturized ultrasound probe into the blood vessel lumen for imaging. It can accurately describe the complex three-dimensional anatomical structure of the blood vessel wall in real time, evaluate the degree of vascular lumen stenosis, and further examine the vulnerability of atherosclerotic plaques. sex and plaque burden, and is considered the new “gold standard” for vascular examination.
  • IVUS can also be used to guide stent placement, evaluate stent intimal hyperplasia, explore the causes of in-stent restenosis, detect late stent malapposition and stent thrombosis, etc.
  • the intravascular ultrasound catheter in the prior art mainly includes a sheath assembly and an inner core assembly.
  • the sheath assembly includes a tube body. A through hole is provided on the distal end of the tube body.
  • the inner core assembly includes a flexible drive shaft and an ultrasound probe.
  • the flexible drive shaft The shaft is partially penetrated in the tube body so that the distal end of the flexible drive shaft is located in the tube body.
  • the ultrasonic probe is disposed at the distal end of the flexible drive shaft.
  • the flexible drive shaft can move along the axial direction of the tube body and can also rotate to drive
  • the ultrasonic probe moves along the axis of the tube body and also rotates.
  • the process of using the intravascular ultrasound catheter is as follows: first, infuse physiological saline into the tube body from the proximal end.
  • the physiological saline carries the air in the tube body and is discharged from the through hole at the distal end of the tube body. Then, the distal end of the intravascular ultrasound catheter is Entering a predetermined position within the blood vessel, the flexible drive shaft is then driven to move in the direction from the distal end to the proximal end (i.e., withdrawn), and also drives the flexible drive shaft to rotate. At the same time, the ultrasonic probe emits ultrasonic signals and collects the data of the blood vessels passing through it. image information. Since the through hole on the distal end of the tube body is always open, during use, especially when the flexible drive shaft is retracting, blood can easily enter the sheath from the through hole, affecting the imaging effect and continuity of use. Therefore, the operator often needs to infuse physiological saline multiple times to drain the blood, which makes the operation cumbersome, prolongs the operation time, and increases the risk of the operation.
  • the object of the present invention is to provide a medical catheter and system, which can be used in blood vessels imaging, and can simplify operations, shorten operation time, and reduce surgical risks.
  • the present invention provides a medical catheter, including:
  • the sheath assembly includes a tube body, the distal end of the tube body is closed, and a one-way channel communicated with the inner cavity of the tube body is formed on the distal side wall of the tube body, the tube body It is configured that when the pressure in the inner cavity of the tube body is greater than or equal to a predetermined value, the one-way channel is opened, and when the pressure in the inner cavity of the tube body is less than the predetermined value, the one-way channel is opened.
  • the channel is closed; and
  • an inner core assembly including a flexible drive shaft and an imaging probe, the distal end of the flexible drive shaft being disposed in the inner cavity of the tube body, the flexible drive shaft being configured to move along the axial direction of the tube body, And it can rotate around its own axis; the imaging probe is arranged at the distal end of the flexible drive shaft.
  • a predetermined area is provided on the distal side wall of the tube body, the predetermined area is configured to be elastic, and a slit is formed on the predetermined area, and the slit constitutes the one-way channel.
  • the sheath assembly further includes a guide head, the guide head is provided at the distal end of the tube body, and a guide wire channel is provided on the guide head, and the axis of the guide wire channel Inclined relative to the axis of the tube body.
  • the distance from the distal end of the slit to the distal end of the guide head is 15 mm to 25 mm; and/or the length of the slit is 1 mm to 3 mm.
  • the material of the predetermined area is selected from any one of polyurethane, polyethylene, silicone, and block polyetheramide elastomer.
  • the flexible drive shaft includes a shaft body and a hydrophilic coating disposed on an outer surface of the shaft body.
  • the sheath assembly further includes a first proximal connection part, an adapter and an irrigation adapter.
  • the adapter is provided at the proximal end of the tube body, and the first proximal connection part is connected to the adapter.
  • the proximal end of the connector is connected, and the inner cavity of the first proximal connection part, the inner cavity of the adapter and the inner cavity of the tube body are connected in sequence, and the flushing connector is provided on the first proximal connection part part and communicates with the inner cavity of the first proximal connecting part.
  • the inner core assembly further includes a second proximal connection portion, the second proximal connection portion is at least partially disposed in the lumen of the first proximal connection portion, the second proximal connection portion
  • the distal end of the connecting part is connected to the flexible drive shaft, and the proximal end of the second proximal connecting part is used to connect to an external driving device. Connected to transmit the driving force provided by the driving device to the flexible driving shaft.
  • a sealing structure is provided between the first proximal connection part and the second proximal connection part.
  • the tube body includes an axially connected proximal tube section and a distal tube section, and the hardness of the proximal tube section is greater than the hardness of the distal tube section.
  • the predetermined value is 20Kpa ⁇ 35Kpa.
  • the present invention also provides a medical system, including:
  • a driving device connected to the flexible driving shaft and used to drive the flexible driving shaft to move along the axial direction of the tube body and to drive the flexible driving shaft to rotate;
  • An imaging host is communicatively connected to the imaging probe.
  • the imaging host is used to send an excitation signal to the imaging probe to drive the imaging probe to emit an image acquisition signal.
  • the imaging host is also used to receive the image obtained by the imaging probe. imaging signal.
  • the medical catheter and system of the present invention have the following advantages:
  • the aforementioned medical catheter includes a sheath assembly and an inner core assembly; wherein, the sheath assembly includes a tube body, the distal end of the tube body is closed, and a unidirectional guide is formed on the distal side wall of the tube body. channel, the tube body is configured to open the one-way channel when the pressure in the inner cavity of the tube body is greater than or equal to a predetermined value, and when the pressure in the inner cavity of the tube body is less than the predetermined value When Moving along the axial direction of the tube body and capable of rotating around its axis, the imaging probe is disposed at the distal end of the flexible drive shaft.
  • the medical catheter can be used for intravascular imaging.
  • physiological saline When used, physiological saline is first perfused into the inner cavity of the tube body from the proximal end of the tube body, and the pressure exerted by the physiological saline on the tube body is greater than The predetermined value, so that the one-way channel is opened, and the physiological saline carries the air in the tube and is discharged from the tube body from the one-way channel, so that the tube body is no longer under pressure, and the one-way The channel is closed; then the distal end of the medical catheter is transported to a predetermined position in the blood vessel according to conventional methods, and then the flexible driving shaft is controlled to move in the direction from the distal end to the proximal end, and the flexible driving shaft is controlled to move around its The axis rotates to drive the imaging probe to rotate.
  • the imaging probe emits images
  • the image collects signals and receives imaging signals from the blood vessel wall.
  • the one-way channel is closed, which can prevent blood from entering the inner cavity of the tube body from the one-way channel, thereby eliminating the need for multiple Infusing normal saline to drain the blood vessels entering the tube body can avoid interference from blood vessels on imaging, allowing continuous imaging. It also simplifies imaging operations, shortens operation time, and reduces surgical risks.
  • Figure 1 is a schematic structural diagram of a medical catheter provided according to an embodiment of the present invention.
  • Figure 2 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention. The figure shows a one-way channel, and the one-way channel is closed;
  • Figure 3 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention.
  • the figure shows a one-way channel, and the one-way channel is open;
  • Figure 4 is a partial structural schematic diagram of a medical catheter provided according to an embodiment of the present invention, showing a guide head and a guide wire channel;
  • Figure 5 is a schematic structural diagram of a medical system provided according to an embodiment of the present invention.
  • each embodiment described below has one or more technical features, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement them in different embodiments separately. some or all of the technical features.
  • those skilled in the art can selectively implement some or all of the technical features in any embodiment based on the disclosure of the present invention and design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a,” “an,” and “the” include plural referents, and the plural form “plurality” includes two or more referents unless the content clearly dictates otherwise.
  • the term “or” is generally used in its sense including “and/or” unless the content clearly indicates otherwise, and the terms “installed”, “connected” and “connected” shall To be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection.
  • the connection can be mechanical or electrical. It can be a direct connection or an indirect connection through an intermediary. It can be an internal connection between two elements or an interaction between two elements.
  • the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
  • proximal and distal refer to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a physician using the medical device, although “proximal”, “distal” ” is not meant to be limiting, but “proximal” generally refers to the end of the medical device that is closest to the physician during normal operation, while “distal” generally refers to the end that first enters the patient’s body.
  • FIG. 1 shows a schematic structural diagram of a medical catheter 10 provided by an embodiment of the present invention
  • FIGS. 2 and 3 show partial structural schematic diagrams of the medical catheter 10
  • the medical catheter 10 includes a sheath assembly 100 and an inner core assembly 200 .
  • the sheath assembly 100 includes a tube body 110, the distal end of the tube body 110 is closed, and a one-way channel 111 is formed on the distal side wall of the tube body 110.
  • the tube body 110 is configured such that when the pressure in the inner cavity of the tube body 110 is greater than or equal to a predetermined value, the one-way channel 111 opens to communicate the inner cavity with the outside world (as shown in Figure 3).
  • the core assembly 200 includes a flexible drive shaft 210 and an imaging probe 220 .
  • the distal end of the flexible drive shaft 210 is disposed in the inner cavity of the tube body 110 .
  • the flexible drive shaft 210 is configured to move along the axial direction of the tube body 110 and to rotate around its axis.
  • the imaging probe 220 is disposed at the distal end of the flexible drive shaft 210 .
  • the medical catheter 10 may be used for intravascular imaging, such that the imaging probe 220 may be an ultrasound transducer.
  • the use process of the medical catheter 10 includes the following steps:
  • Step S1 Perfuse physiological saline from the proximal end of the tube body 110 into the inner cavity of the tube body 110.
  • the physiological saline generates fluid pressure in the inner cavity of the tube body 110.
  • the one-way channel 111 is opened, and the physiological saline is discharged from the tube body 110 from the one-way channel 111, and during the discharge process, the physiological saline also carries the tube
  • the air in the body 110 escapes from the tube body 110 together. It will be appreciated that this step is performed outside the patient's body.
  • Step S2 Transport the distal end of the medical catheter 10 to a predetermined position in the blood vessel along the guide wire that has been introduced into the blood vessel in advance.
  • Step S3 Control the flexible driving shaft 210 to move in the direction from the distal end to the proximal end, and control the flexible driving shaft 210 to rotate around its own axis, so that the imaging probe 220 moves along the flexible driving shaft 210.
  • the distal end moves toward the proximal end and rotates around the axis of the flexible drive shaft 210 .
  • the imaging probe 220 also transmits image acquisition signals and receives image signals, and the image signals are used to obtain intravascular image information.
  • the filling of the tube body 110 has stopped. Inject physiological saline, so the pressure in the tube body 110 disappears and the one-way channel 111 is closed, so the blood can be prevented from entering the inner cavity of the tube body 110 from the one-way channel 111, preventing blood from affecting the imaging process. Without causing interference, there is no need to repeatedly infuse physiological saline to flush the tube body, thereby simplifying the operating steps of the imaging process, improving the continuity of the imaging process, shortening the operation time, and improving the safety of the operation.
  • a predetermined area is provided on the distal side wall of the tube body 110, the predetermined area is configured to be elastic, and a slit is formed in the predetermined area.
  • the predetermined area deforms and stores elastic potential energy, so that the slit opens.
  • the predetermined area releases elastic potential energy and resumes deformation, so that the slit is closed.
  • the slits constitute the one-way channel 111 .
  • the material of the predetermined area is selected from any one of polyurethane, polyethylene, silicone and block polyetheramide elastomer (Pebax).
  • the slit extends along the axial direction of the tube body 110 such that the slit has opposite proximal ends and distal ends in the axial direction of the tube body 110 . It can be understood that the slit may be parallel to the axis of the tube body 110 or may be inclined relative to the axis of the tube body 110, which is not limited in this embodiment.
  • the predetermined value is related to the size of the slit, and the length of the slit cannot be too large or too small. If the length of the slit is too large, it is not conducive to the closing of the slit. If the length of the seam is too small, the predetermined value will be too large.
  • the length of the slit is 1 mm to 3 mm, and accordingly, the predetermined value is 20 Kpa to 35 Kpa.
  • the slit should be as close as possible to the distal end of the tube body 110. In this way, the physiological saline can be used to remove as much gas as possible within the entire axial length of the tube body 110. discharge.
  • the tube body 110 may include an axially connected proximal tube section 112 and a distal tube section 113.
  • the hardness of the proximal tube section 112 is greater than that of the distal tube section 113, so that the medical catheter 10 has a higher hardness. Good push capability.
  • the slit is provided on the distal tube section 113 .
  • the sheath assembly 100 further includes a guide head 120, which is disposed at the distal end of the tube body 110, and is provided with There is a guide wire channel 121, and the axis of the guide wire channel 121 is inclined relative to the axis of the tube body 110.
  • the sheath assembly 100 is sleeved on the guide wire through the guide wire channel 121, and then The distal end of the tube body 110 can reach a predetermined position in the blood vessel under the guidance of the guide wire.
  • the distance from the distal end of the guide head 120 to the distal end of the slit is preferably 15 mm to 25 mm.
  • the guide head 120 is also provided with a developing element (not shown in the figure).
  • the developing element is used to display the position of the guide head 120 within the blood vessel, thereby facilitating the operator to determine the location of the guide head 120 .
  • the sheath assembly 100 further includes a first proximal connection part 130, an adapter 140 and an irrigation connector 150.
  • the adapter 140 connects the tube body 110 and the first proximal connection part 130 .
  • the first proximal connection part 130 includes a head 131 and a coupling tube 132.
  • the head 131 is provided at the proximal end of the coupling tube 132.
  • the adapter 140 specifically connects the distal end of the coupling tube 132 and the coupling tube 132.
  • the irrigation connector 150 is provided on the first proximal connecting part 130 , specifically on the head 131 , and communicates with the inner cavity of the tube body 110 .
  • the irrigation connector 150 is, for example, a Luer connector, which is used to connect with an external perfusion mechanism for perfusing physiological saline into the tube body 110 .
  • the flushing connector 150 is also provided with a one-way valve to prevent the reflux of physiological saline.
  • the flexible driving shaft 210 includes a shaft body 211 and a hydrophilic coating 212 provided on the outer surface of the shaft body 211 .
  • the hydrophilic coating 212 may be polyvinylpyrrolidone (PVP) or any other suitable hydrophilic coating.
  • the shaft body 211 is preferably a three-dimensional spiral spring structure, which has sufficient flexibility while maintaining the rigidity required for rotation.
  • the inner core assembly 200 further includes a second proximal connection part 230 , the second proximal connection part 230 is provided at the proximal end of the flexible drive shaft 210 , and the third The proximal ends of the two proximal connecting parts 230 are used to connect with an external driving device 20 (as shown in FIG. 5 ), so as to transmit the driving force provided by the driving device 20 to the flexible driving shaft 210, thereby driving the
  • the flexible driving shaft 210 moves along the axial direction of the tube body 110, and also drives the flexible driving shaft 210 to move along the axial direction of the tube body 110.
  • Shaft 210 rotates.
  • the sheath assembly 100 can be assembled first, and then the inner core assembly 200 can be assembled, and then the distal end of the flexible driving shaft 210 can be inserted into the tube body 110, and the third
  • the two proximal connection parts 230 are at least partially disposed in the first proximal connection part 130, specifically the inner cavity of the head 131, and between the first proximal connection part 130 and the second proximal end
  • a sealing structure 300 is provided between the connecting parts 230 to prevent air from entering the tube body 110 from the first proximal connecting part 130 .
  • the imaging probe 220 when assembling the medical catheter 10, should be as close as possible to the distal end of the tube body 110, so that the flexible driving shaft 210 drives the imaging probe 220 along the distal direction.
  • the imaging probe 220 can move as far as possible in the axial direction of the tube body 110, so that the imaging probe 220 moves along the axial direction of the blood vessel.
  • the moving distance should be as large as possible to increase the imaging range of blood vessels.
  • an embodiment of the present invention also provides a medical system 1 , which includes the medical catheter 10 , the driving device 20 and the imaging host 30 as mentioned above.
  • the driving device 20 is connected to the proximal end of the flexible driving shaft 210 and is used to drive the flexible driving shaft 210 to move along the axial direction of the tube body 110 and to drive the flexible driving shaft 210 to rotate around its axis.
  • the imaging host 30 is communicatively connected with the imaging probe 220.
  • the imaging host 30 is used to send an excitation signal to the imaging probe 220 to drive the imaging probe 220 to emit an image acquisition signal.
  • the imaging host 30 also uses to receive the imaging signal obtained by the imaging probe 220 . It can be understood that when the imaging probe 220 is an ultrasonic transducer, the image acquisition signal is an ultrasonic wave, and the imaging signal is an electrical signal obtained by the imaging host 30 according to the wave signal returned by the blood vessel wall.

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Abstract

本发明提供了一种医用导管及***，所述医用导管包括：鞘管组件，包括管体，所述管体的远端端部封闭，且所述管体的远端侧壁上形成有单向通道，所述管体被配置为当所述管体的内腔中的压力大于或等于预定值时，所述单向通道打开，当所述管体的内腔中的压力小于所述预定值时，所述单向通道关闭；以及，内芯组件，包括柔性驱动轴和成像探头，所述柔性驱动轴的远端设置在所述管体的内腔中，所述柔性驱动轴被配置为能够沿所述管体的轴向移动，且能够绕自身轴线自转；所述成像探头设置在所述柔性驱动轴的远端。该医用导管可用于血管内成像，并能够简化成像操作、缩短手术时间，提高安全性。

Description

一种医用导管及*** 技术领域
本发明涉及医疗器械技术领域，具体涉及一种医用导管及***。
背景技术
血管内超声成像(Intravascular ultrasound tomography，IVUS)，是一种结合了无创的超声检查与微创的导管介入技术的新型诊断方法。IVUS通过导管技术将微型化的超声探头置于血管腔内进行成像，能实时准确地描述血管壁复杂的三维解剖结构，评估血管腔狭窄程度，并可进一步检查动脉粥样硬化斑块的易损性和斑块负荷，被认为是血管检查的新的“金标准”。此外，IVUS还可以用于指导支架的置入、支架内膜增生的评价、支架内再狭窄原因的探讨、支架晚期贴壁不良和支架内血栓的检出等。
现有技术中的血管内超声导管主要包括鞘管组件和内芯组件，鞘管组件包括管体，管体的远端上设有一通孔，内芯组件包括柔性驱动轴和超声探头，柔性驱动轴部分地穿设在管体内以使得柔性驱动轴的远端位于管体内，超声探头设置在柔性驱动轴的远端，该柔性驱动轴能够沿管体的轴向移动且还能够自转，以带动超声探头沿管体的轴向移动并还进行自转。血管内超声导管的使用过程为：首先从近端向管体灌注生理盐水，生理盐水携带管体内的空气，并一起从管体远端的通孔处排出，然后使血管内超声导管的远端进入血管内的预定位置，接着驱使柔性驱动轴沿远端向近端的方向移动(即回撤)，并还驱使柔性驱动轴旋转，同时超声探头发射超声波信号，并采集其经过部位的血管的图像信息。由于管体远端上的通孔始终处于开放状态，在使用过程中，尤其是在柔性驱动轴在回撤时，血液极容易从通孔处进入鞘管，影响成像效果及使用的连续性，因此施术者往往还需要多次灌注生理盐水以排出血液，导致操作繁琐，延长手术时间，增加手术风险。
发明内容
本发明的目的在于提供一种医用导管及***，该医用导管可用于血管内 成像，并能够简化操作，缩短手术时间，减少手术风险。
为实现上述目的，本发明提供了一种医用导管，包括：
鞘管组件，包括管体，所述管体的远端端部封闭，且所述管体的远端侧壁上形成有与所述管体的内腔相通的单向通道，所述管体被配置为当所述管体的内腔中的压力大于或等于预定值时，所述单向通道打开，当所述管体的内腔中的压力小于所述预定值时，所述单向通道关闭；以及
内芯组件，包括柔性驱动轴和成像探头，所述柔性驱动轴的远端设置在所述管体的内腔中，所述柔性驱动轴被配置为能够沿所述管体的轴向移动，且能够绕自身轴线自转；所述成像探头设置在所述柔性驱动轴的远端。
可选地，所述管体的远端侧壁上设有一预定区域，所述预定区域被配置为具有弹性，所述预定区域上形成有切缝，所述切缝构成所述单向通道。
可选地，所述鞘管组件还包括导引头，所述导引头设置在所述管体的远端，且所述导引头上设置有导丝通道，所述导丝通道的轴线相对于所述管体的轴线倾斜。
可选地，所述切缝的远端端部到所述导引头的远端的距离为15mm～25mm；和/或，所述切缝的长度为1mm～3mm。
可选地，所述预定区域的材料选自聚氨酯、聚乙烯、硅胶、及嵌段聚醚酰胺弹性体中的任一种。
可选地，所述柔性驱动轴包括轴体和设置在所述轴体的外表面的亲水涂层。
可选地，所述鞘管组件还包括第一近端连接部、转接头和冲洗接头，所述转接头设置在所述管体的近端，所述第一近端连接部与所述转接头的近端连接，且所述第一近端连接部的内腔、所述转接头的内腔以及所述管体的内腔依次连通，所述冲洗接头设置在所述第一近端连接部上，并与所述第一近端连接部的内腔连通。
可选地，所述内芯组件还包括第二近端连接部，所述第二近端连接部至少部分地设置在所述第一近端连接部的内腔中，所述第二近端连接部的远端与所述柔性驱动轴连接，所述第二近端连接部的近端用于与外部的驱动装置 连接，以将所述驱动装置提供的驱动力传递至所述柔性驱动轴。
可选地，所述第一近端连接部与所述第二近端连接部之间设置有密封结构。
可选地，所述管体包括轴向连接的近端管段和远端管段，所述近端管段的硬度大于所述远端管段的硬度。
可选地，所述预定值为20Kpa～35Kpa。
为实现上述目的，本发明还提供了一种医用***，包括：
如前任一项所述的医用导管；
驱动装置，与所述柔性驱动轴连接，并用于驱使所述柔性驱动轴沿所述管体的轴向移动，以及驱使所述柔性驱动轴自转；
成像主机，与所述成像探头通信连接，所述成像主机用于向所述成像探头发送激励信号以驱使所述成像探头发射图像采集信号，所述成像主机还用于接收所述成像探头获得的成像信号。
与现有技术相比，本发明的医用导管及***具有如下优点：
前述的医用导管包括鞘管组件和内芯组件；其中，所述鞘管组件包括管体，所述管体的远端端部封闭，且所述管体的远端侧壁上形成有单向通道，所述管体被配置为当所述管体的内腔中的压力大于或等于预定值时，所述单向通道打开，当所述管体的内腔中的压力小于所述预定值时，所述单向通道关闭；所述内芯组件包括柔性驱动轴和成像探头，所述柔性驱动轴的远端设置在所述管体的内腔中，所述柔性驱动轴被配置为能够沿所述管体的轴向移动，且能够绕其轴线自转，所述成像探头设置在所述柔性驱动轴的远端。所述医用导管可用于血管内成像，使用时，首先从所述管体的近端向所述管体的内腔中灌注生理盐水，且所述生理盐水施加于所述管体上的压力大于所述预定值，从而单向通道打开，且所述生理盐水携带管体内的空气一起从所述单向通道处排出所述管体，并使所述管体内不再受到压力，所述单向通道关闭；然后按照常规方法将所述医用导管的远端输送至血管内的预定位置处，再控制所述柔性驱动轴沿远端向近端的方向移动，以及控制所述柔性驱动轴绕其轴线自转，以带动所述成像探头自转，与此同时，所述成像探头发射图 像采集信号并接收血管壁的成像信号。所述医用导管的使用过程中，当所述医用导管的远端进入血管内后，所述单向通道关闭，可以阻止血液从所述单向通道处进入管体的内腔，进而无需多次灌注生理盐水以排出进入管体的血管，也即可以避免血管对成像造成干扰，使得成像可以连续的进行，还简化了成像操作，缩短手术时间，降低手术风险。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1是本发明根据一实施例所提供的医用导管的结构示意图；
图2是本发明根据一实施例所提供的医用导管的局部结构示意图，图中示出单向通道，且单向通道关闭；
图3是本发明根据一实施例所提供的医用导管的局部结构示意图，图中示出单向通道，且单向通道打开；
图4是本发明根据一实施例所提供的医用导管的局部结构示意图，图中示出导引头及导丝通道；
图5是本发明根据一实施例所提供的医用***的结构示意图。
[附图标记说明如下]：
1-医用***；
10-医用导管，100-鞘管组件，110-管体，111-单向通道，112-近端管段，
113-远端管段，120-导引头，121-导丝通道，130-第一近端连接部，131-头部，132-接合管，140-转接头，150-冲洗接头，200-内芯组件，210-柔性驱动轴，211-轴体，212-亲水涂层，220-成像探头，230-第二近端连接部，300-密封结构；
20-驱动装置；
30-成像主机。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由 本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的型态、数量及比例可为一种随意的改变，且其组件布局型态也可能更为复杂。
另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本文中，术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的 比例，仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
图1示出了本发明一实施例所提供的医用导管10的结构示意图，图2及图3示出了所述医用导管10的局部结构示意图。如图1至图3所示，所述医用导管10包括鞘管组件100和内芯组件200。其中，所述鞘管组件100包括管体110，所述管体110的远端端部封闭，且所述管体110的远端侧壁上形成有单向通道111。所述管体110被配置为当所述管体110的内腔中的压力大于或等于预定值时，所述单向通道111打开以将内腔与外界连通(如图3所示)，当所述管体110的内腔中压力小于所述预定值时，所述单向通道111关闭(如图2所示)。所述内芯组件200包括柔性驱动轴210和成像探头220。所述柔性驱动轴210的远端设置在所述管体110的内腔中，所述柔性驱动轴210被配置为能够沿所述管体110的轴向移动，且能够绕其轴线自转。所述成像探头220设置在所述柔性驱动轴210的远端。
所述医用导管10可以用于血管内成像，如此，所述成像探头220可以是超声波换能器。所述医用导管10的使用过程包括如下步骤：
步骤S1：从所述管体110的近端向所述管体110的内腔灌注生理盐水，所述生理盐水在所述管体110的内腔中产生流体压力，当所述流体压力大于所述预定值时，所述单向通道111打开，并使得所述生理盐水从所述单向通道111处排出所述管体110，且在排出的过程中，所述生理盐水还携带所述管体110内的空气一起脱离所述管体110。可以理解，本步骤在患者的体外进行。
步骤S2：沿预先导入血管的导丝将所述医用导管10的远端输送至血管内的预定位置。
步骤S3：控制所述柔性驱动轴210沿远端向近端的方向移动，以及控制所述柔性驱动轴210绕其自身的轴线自转，从而所述成像探头220随所述柔性驱动轴210一起沿远端向近端的方向移动，并绕所述柔性驱动轴210的轴线旋转。与此同时，所述成像探头220还发射图像采集信号，并接收图像信号，所述图像信号用于获取血管内图像信息。
在此，当所述医用导管10的远端进入血管时，已停止向所述管体110灌 注生理盐水，因而所述管体110内的压力消失，所述单向通道111关闭，故而可以阻止血液从所述单向通道111处进入所述管体110的内腔，避免血液对成像过程造成干扰，也就无需重复多次地灌注生理盐水以冲洗所述管体，由此可以简化成像过程的操作步骤，提高成像过程的连续性，缩短手术时间，提高手术安全性。
可选地，所述管体110的远端侧壁上设有一预定区域，所述预定区域被配置为具有弹性，所述预定区域上形成有切缝。当所述管体110的内腔中的压力大于或等于所述预定值时，所述预定区域发生变形并存储弹性势能，以使得所述切缝打开，当所述管体110内的压力小于所述预定值时，所述预定区域释放弹性势能并恢复形变，以使得所述切缝闭合。换句话说，本实施例中，所述切缝构成所述单向通道111。所述预定区域的材料选自聚氨酯、聚乙烯、硅胶及嵌段聚醚酰胺弹性体(Pebax)中的任一种。
所述切缝沿所述管体110的轴向延伸，以使得所述切缝在所述管体110的轴向上具有相对的近端和远端。可以理解，所述切缝可以与所述管体110的轴线平行，也可以相对于所述管体110的轴线倾斜，本实施例对此不做限定。所述预定值与所述切缝的尺寸有关，所述切缝的长度不能太大也不能太小，若所述切缝的长度太大，不利于所述切缝的闭合，若所述切缝的长度太小，又会导致所述预定值过大。可选地，所述切缝的长度为1mm～3mm，与之相应地，所述预定值为20Kpa～35Kpa。此外，所述切缝应尽可能地靠近所述管体110的远端端部，这样做，可以利用生理盐水尽可能地将位于所述管体110的轴向的全部长度范围内的气体全部排出。
另外，所述管体110可以包括轴向连接的近端管段112和远端管段113，所述近端管段112的硬度大于所述远端管段113的硬度，以使得所述医用导管10具有较好的推送能力。所述切缝设置在所述远端管段113上。
以及，如图1及图4所示，所述鞘管组件100还包括导引头120，所述导引头120设置在所述管体110的远端，且所述导引头120上设有导丝通道121，所述导丝通道121的轴线相对于所述管体110的轴线倾斜。如此，在前述的步骤S2中，所述鞘管组件100通过所述导丝通道121套设在所述导丝上，进 而所述管体110的远端可以在所述导丝的导引下抵达血管内的预定位置。所述导引头120的远端到所述切缝的远端端部的距离优选为15mm～25mm。
可选地，所述导引头120上还设置有显影元件(图中未示出)，所述显影元件用于显示所述导引头120在血管内的位置，进而便于施术者判断所述管体110的远端在血管内的位置。
进一步地，所述鞘管组件100还包括第一近端连接部130、转接头140和冲洗接头150。所述转接头140连接所述管体110和所述第一近端连接部130。所述第一近端连接部130包括头部131和接合管132，所述头部131设置在所述接合管132的近端，所述转接头140具体连接所述接合管132的远端和所述管体110的近端，通过设置所述转接头140可以使得两段不同的管材牢固地接合在一起。并且，所述第一近端连接部130内腔、所述转接头140的内腔和所述管体110的内腔依次连通。所述冲洗接头150设置在所述第一近端连接部130上，具体是设置在所述头部131上，并与所述管体110的内腔连通。所述冲洗接头150例如是鲁尔接头，其用于与外部的灌注机构连接，以用于向所述管体110灌注生理盐水。可选地，所述冲洗接头150上还设置有单向阀，以阻止生理盐水反流。
进一步地，所述柔性驱动轴210包括轴体211和设置在所述轴体211的外表面的亲水涂层212。通过在所述轴体211的外表面上设置所述亲水涂层212可以在灌注生理盐水的时候使得生理盐水快速地浸润所述柔性驱动轴210的外表面，减少附着在所述柔性驱动轴210上的气泡，以尽可能地排出管体110内的空气。所述亲水涂层212可以是聚乙烯吡咯烷酮(PVP)或其他任意合适的亲水涂层。另外，所述轴体211优选为三维螺旋的弹簧结构，其在具有足够柔软性的同时也能够保持旋转所需的刚性。
进一步地，请返回参考图1，所述内芯组件200还包括第二近端连接部230，所述第二近端连接部230设置在所述柔性驱动轴210的近端，且所述第二近端连接部230的近端用于与外部的驱动装置20(如图5所示)连接，以用于将所述驱动装置20提供的驱动力传递至所述柔性驱动轴210，进而驱使所述柔性驱动轴210沿所述管体110的轴向移动，同时还驱使所述柔性驱动 轴210自转。
组装所述医用导管10时，可以首先组装所述鞘管组件100，然后组装所述内芯组件200，再将所述柔性驱动轴210的远端***所述管体110，并使所述第二近端连接部230至少部分地设置在所述第一近端连接部130具体是所述头部131的内腔中，且在所述第一近端连接部130与所述第二近端连接部230之间设置密封结构300，以避免空气从所述第一近端连接部130处进入所述管体110。并且，在组装所述医用导管10时，所述成像探头220应尽可能地靠近所述管体110的远端端部，以使得所述柔性驱动轴210带动所述成像探头220沿远端向近端的方向在所述管体110内移动时，所述成像探头220可以在所述管体110的轴向上的移动距离尽可能地大，进而使得所述成像探头220沿血管的轴向上的移动距离尽可能地大，达到增大血管的成像范围的效果。
进一步地，如图5所示，本发明实施例还提供了一种医用***1，所述医用***1包括如前所述的医用导管10、驱动装置20和成像主机30。所述驱动装置20与所述柔性驱动轴210的近端连接，并用于驱使所述柔性驱动轴210沿所述管体110的轴向移动，以及驱使所述柔性驱动轴210绕其轴线自转。所述成像主机30与所述成像探头220通信连接，所述成像主机30用于向所述成像探头220发送激励信号，以驱使所述成像探头220发射图像采集信号，所述成像主机30还用于接收所述成像探头220所获得的成像信号。可以理解，当所述成像探头220为超声波换能器时，所述图像采集信号即超声波，所述成像信号即为所述成像主机30根据被血管壁返回的波信号所得到的电信号。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (12)

  1. 一种医用导管，其特征在于，包括：
    鞘管组件，包括管体，所述管体的远端端部封闭，且所述管体的远端侧壁上形成有与所述管体的内腔相通的单向通道，所述管体被配置为当所述管体的内腔中的压力大于或等于预定值时，所述单向通道打开，当所述管体的内腔中的压力小于所述预定值时，所述单向通道关闭；以及，
    内芯组件，包括柔性驱动轴和成像探头，所述柔性驱动轴的远端设置在所述管体的内腔中，所述柔性驱动轴被配置为能够沿所述管体的轴向移动，且能够绕自身轴线自转；所述成像探头设置在所述柔性驱动轴的远端。
  2. 根据权利要求1所述的医用导管，其特征在于，所述管体的远端侧壁上设有一预定区域，所述预定区域被配置为具有弹性，所述预定区域上形成有切缝，所述切缝构成所述单向通道。
  3. 根据权利要求2所述的医用导管，其特征在于，所述鞘管组件还包括导引头，所述导引头设置在所述管体的远端，且所述导引头上设置有导丝通道，所述导丝通道的轴线相对于所述管体的轴线倾斜。
  4. 根据权利要求3所述的医用导管，其特征在于，所述切缝的远端到所述导引头的远端端部的距离为15mm～25mm；和/或，
    所述切缝的长度为1mm～3mm。
  5. 根据权利要求2所述的医用导管，其特征在于，所述预定区域的材料选自聚氨酯、聚乙烯、硅胶及嵌段聚醚酰胺弹性体中的任一种。
  6. 根据权利要求1所述的医用导管，其特征在于，所述柔性驱动轴包括轴体和设置在所述轴体的外表面的亲水涂层。
  7. 根据权利要求1所述的医用导管，其特征在于，所述鞘管组件还包括第一近端连接部、转接头和冲洗接头，所述转接头设置在所述管体的近端，所述第一近端连接部与所述转接头的近端连接，且所述第一近端连接部的内腔、所述转接头的内腔以及所述管体的内腔依次连通，所述冲洗接头设置在所述第一近端连接部上，并与所述第一近端连接部的内腔连通。
  8. 根据权利要求7所述的医用导管，其特征在于，所述内芯组件还包括第二近端连接部，所述第二近端连接部至少部分地设置在所述第一近端连接部的内腔中，所述第二近端连接部的远端与所述柔性驱动轴连接，所述第二近端连接部的近端用于与外部的驱动装置连接，以将所述驱动装置提供的驱动力传递至所述柔性驱动轴。
  9. 根据权利要求8所述的医用导管，其特征在于，所述第一近端连接部与所述第二近端连接部之间设置有密封结构。
  10. 根据权利要求1-9中任一项所述的医用导管，其特征在于，所述管体包括轴向连接的近端管段和远端管段，所述近端管段的硬度大于所述远端管段的硬度。
  11. 根据权利要求1-9中任一项所述的医用导管，其特征在于，所述预定值为20Kpa～35Kpa。
  12. 一种医用***，其特征在于，包括：
    如权利要求1-11中任一项所述的医用导管；
    驱动装置，与所述柔性驱动轴连接，并用于驱使所述柔性驱动轴沿所述管体的轴向移动，以及驱使所述柔性驱动轴自转；
    成像主机，与所述成像探头通信连接，所述成像主机用于向所述成像探头发送激励信号以驱使所述成像探头发射图像采集信号，所述成像主机还用于接收所述成像探头获得的成像信号。
PCT/CN2023/078480 2022-03-21 2023-02-27 一种医用导管及*** WO2023179316A1 (zh)

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