WO2024041570A1 - Dispositif d'administration et système médical - Google Patents

Dispositif d'administration et système médical Download PDF

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Publication number
WO2024041570A1
WO2024041570A1 PCT/CN2023/114444 CN2023114444W WO2024041570A1 WO 2024041570 A1 WO2024041570 A1 WO 2024041570A1 CN 2023114444 W CN2023114444 W CN 2023114444W WO 2024041570 A1 WO2024041570 A1 WO 2024041570A1
Authority
WO
WIPO (PCT)
Prior art keywords
reducing
undulating
rotating shaft
bending
bendable
Prior art date
Application number
PCT/CN2023/114444
Other languages
English (en)
Chinese (zh)
Inventor
胡占明
周冠冠
李文思
李芳�
Original Assignee
应脉医疗科技(上海)有限公司
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 CN202222240440.7U external-priority patent/CN218943605U/zh
Priority claimed from CN202211024156.4A external-priority patent/CN115531040A/zh
Application filed by 应脉医疗科技(上海)有限公司 filed Critical 应脉医疗科技(上海)有限公司
Publication of WO2024041570A1 publication Critical patent/WO2024041570A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • the embodiments of the present application relate to the technical field of medical devices, and in particular to a delivery device and a medical system.
  • these valves may fail or decay due to congenital and acquired factors.
  • the valve between the left atrium and left ventricle is called the mitral valve.
  • mitral valve fails to work properly, blood from the left ventricle can flow back into the left atrium during systole, which is called mitral regurgitation.
  • the disease is generally treated surgically.
  • One procedure involves suturing parts of the mitral valve leaflets directly to each other (called an "Alfieri” suture), which is extremely difficult and prone to many complications.
  • an "Alfieri” suture suturing parts of the mitral valve leaflets directly to each other
  • transseptal technology and related devices have been developed to treat this type of disease through minimally invasive intervention.
  • the transseptal technique involves inserting a catheter into the right femoral vein, up the inferior vena cava, and into the right atrium, and then passing the catheter through the right interatrial septum into the left atrium.
  • a leaflet clip is delivered to the heart and clamped onto the coapting edges of the mitral valve leaflets and holds them together to simulate the "Alfieri" suture.
  • the delivery equipment includes an adjustable bending sheath tube, a bending control device, etc. The operator adjusts the different bending angles of the end of the adjustable bending sheath tube by operating the adjustment handle to deliver the leaflet clip to the appropriate position in the heart.
  • the degree of bending of the end of the adjustable sheath tube in existing delivery equipment needs to be judged by ultrasound, X-ray and other imaging means, and imaging means is used to determine whether the bending angle of the end of the adjustable sheath tube has been It is not accurate and reliable enough to reach the extreme position. Therefore, the operator may use excessive force when rotating the adjustment handle, which may cause the sheath control wire to break and cause a medical accident.
  • Embodiments of the present application provide a delivery device and a medical system that allow the operator to accurately determine the degree of bending of the bendable portion, ensure the normal use of the delivery device, improve the safety of the delivery device, and prevent medical accidents.
  • a conveying device including:
  • the sheath assembly includes an adjustable and bendable sheath.
  • the proximal end of the adjustable and bendable sheath is fixed on the base.
  • the adjustable and bendable sheath is fixed on the base.
  • the distal end of the sheath is provided with a bendable portion; a bending control component provided on the base, the bending control component is used to control the bending of the bendable portion; and a sound warning component, the sound warning component It includes a undulating member and a reducing member. When the bendable part approaches a preset angle, the undulating member contacts the reducing member to emit a warning sound.
  • Embodiments of the present application also provide a medical system, including an implant prosthesis and a delivery device as described in the first aspect, the implant prosthesis is detachably connected to the bendable part, or the implant The prosthesis is carried on the flexible part.
  • Embodiments of the present application also provide a medical system, including an actuator and the delivery device as described in the first aspect, the actuator being connected to the bendable portion.
  • the delivery equipment provided by the embodiment of the present application includes a base, a sheath assembly disposed on the base, a bending control assembly and an audio warning assembly, wherein the sheath assembly includes an adjustable bending The proximal end of the adjustable and bendable sheath is fixed on the base, the distal end of the adjustable and bendable sheath is provided with a bendable part, the bending control component is used to control the bending of the bendable part, and the sound warning component includes a wave component and a The reducing member, when the bendable part approaches the preset angle under the control of the bending control component, the undulating member contacts the reducing member to emit a warning sound.
  • the operator can accurately judge the bending degree of the bendable part by using the warning sound information (for example, the presence or absence of the sound, the size, the frequency of the sound, etc.) emitted by the sound warning component, ensuring the normal use of the conveying equipment, and improving the efficiency of the conveying equipment. Safety to prevent medical accidents.
  • the warning sound information for example, the presence or absence of the sound, the size, the frequency of the sound, etc.
  • Figure 1 is a cross-sectional view of the overall structure of the conveying equipment according to one embodiment of the present application
  • Figure 2 is an enlarged schematic view of the proximal end of the delivery device shown in Figure 1;
  • Figure 3 is a schematic diagram of the cooperation between the undulating member and the reducing member in the sound warning assembly when the bendable part is not bent according to an embodiment of the present application;
  • Figure 4 is a schematic diagram of the cooperation between the wave column and the reducing member in the sound warning assembly when the bendable portion is bent according to an embodiment of the present application;
  • Figure 5 is a schematic structural diagram of a wave member in the sound warning assembly according to an embodiment of the present application.
  • Figure 6 is a schematic structural diagram of another wave member in the sound warning assembly according to an embodiment of the present application.
  • Figure 7 is a schematic structural diagram of another wave member in the sound warning assembly according to an embodiment of the present application.
  • Figure 8 is a schematic structural diagram of a diameter reducing member in the sound warning assembly according to an embodiment of the present application.
  • Figure 9 is a schematic structural diagram of another reducing part in the sound warning assembly according to an embodiment of the present application.
  • Figure 10 is a schematic structural diagram of another reducing part in the sound warning assembly according to an embodiment of the present application.
  • Figure 11 is a schematic structural diagram of a housing of a conveying device according to an embodiment of the present application.
  • Figure 12 is a schematic structural diagram of the diameter reducing member in the sound warning assembly according to one embodiment of the present application being arranged on the housing;
  • Figure 13 is a schematic structural diagram of the sound warning component and the bending control component of another embodiment of the present application.
  • Figure 14 is a schematic structural diagram of the sound warning component in Figure 13 after its position has been changed;
  • Figure 15 is a schematic structural diagram of the sound warning component and the bending control component of another embodiment of the present application.
  • Figure 16 is a schematic structural diagram of the sound warning component in Figure 15 after its position has been changed;
  • Figure 17 is a schematic diagram of a medical system according to an embodiment of the present application.
  • Figure 18 is a schematic diagram of a medical system according to an embodiment of the present application.
  • the terms “upper”, “lower”, “left”, “right”, “front”, “back”, “top”, “bottom”, “inner”, “outer”, “middle” ”, “vertical”, “horizontal”, “horizontal”, “longitudinal”, etc. indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings. These terms are mainly used to better describe the present application and its embodiments and are not intended to limit the indicated device, element or component to having a specific orientation, or to be constructed and operated in a specific orientation.
  • the terms “installed”, “set up”, “provided”, “established”, “connected” and “connected” should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or between two devices, components or components. internal connectivity.
  • installed can be a fixed connection, a detachable connection, or an integral structure
  • it can be a mechanical connection or an electrical connection
  • it can be directly connected, or indirectly connected through an intermediate medium, or between two devices, components or components. internal connectivity.
  • first means two or more.
  • the delivery equipment provided by one embodiment of the present application, as shown in Figures 1 to 4, includes: a base 100, a sheath assembly 200 provided on the base 100, a bending control assembly 300 and an audio warning assembly 400, wherein,
  • the sheath assembly 200 includes an adjustable and bendable sheath 210.
  • the proximal end of the adjustable and bendable sheath 210 is fixed on the base 100.
  • the distal end of the adjustable and bendable sheath 210 is provided with a bendable portion 211.
  • the bending control assembly 300 is In order to control the bending of the bendable part 211, the sound warning component 400 includes a undulating member 410 and a reducing member 420. When the bendable part 211 approaches the preset angle under the control of the bending control component 300, the undulating member 410 and the reducing member 420 Touch to make a warning sound.
  • this embodiment uses the warning sound information emitted by the sound warning component, so that the operator can accurately determine the degree of bending of the flexible part 211 in the body without relying on diagnostic equipment such as CT and X-ray, ensuring that the delivery equipment Normal use improves the safety of transportation equipment and prevents medical accidents.
  • This embodiment has no special restrictions on the "preset angle". It can be the maximum bending angle reached by the bendable portion when the bendable portion is bent or the control wire is stressed to the physical limit, or it can be the product of the maximum bending angle and the safety factor, that is, the maximum The safety angle is either the angle corresponding to the limit of the surgical operation or the angle corresponding to the specific purpose.
  • the sheath assembly 200 includes a proximal end and a distal end, and the adjustable-bend sheath 210 extends from the proximal end of the sheath assembly 200 to the distal end of the sheath assembly 200 and forms an adjustable-bend sheath axis.
  • the proximal end of the adjustable and curved sheath 210 can be rigid to provide support, and the proximal end of the adjustable and curved sheath 210 can be flexible to improve compliance and facilitate the entry of the adjustable and curved sheath 210 into the natural orifice of the human body.
  • the proximal end of the adjustable bending sheath 210 can also be partially rigid and partially flexible along the axial direction, thus providing sufficient support while extending along the natural orifice of the human body.
  • the bendable portion 211 is provided at the distal end of the adjustable bending sheath 210, and the bendable portion 211 can be deflected relative to the axis of the adjustable bending sheath, so that the prosthesis can be detachably connected to or carried by the bending portion 211, or Connected actuators allow for more precise movement or placement.
  • the specific structure of the bendable portion 211 is not particularly limited, as long as the bendable portion 211 can meet actual needs.
  • the bendable part 211 may be a tube made of elastic material; for another example, the bendable part 211 may be a mechanical structure with multiple bending degrees of freedom, such as a Hooke hinge or a universal joint; for another example, the bendable part 211 It can also have a bent structure such as a hypotube structure or a corrugated tube structure.
  • the bendable portion 211 may bend upward and/or downward. In some other embodiments, the bendable portion 211 may bend to the left and/or right (ie, perpendicular to the direction of the paper of FIG. 1 ). In other embodiments, the bendable portion 211 may be bent in other directions.
  • the proximal end of the adjustable and bendable sheath 210 in the sheath assembly 200 is fixed to the base 100 .
  • the base 100 is provided with an axial through hole for accommodating the adjustable bending sheath 210 .
  • the adjustable bending sheath 210 passes through the axial through hole and is fixedly connected to the base 100 .
  • the sheath assembly 200 further includes a sheath mounting seat, which is used to connect the adjustable bending sheath 210 and the base 100 , that is, the sheath mounting seat is accommodated in the base 100 and is connected to the base 100 .
  • 100 are fastened with screws, and the sheath tube mounting seat is set on the adjustable bending sheath tube 210 and fixed and bonded with medical glue.
  • the material of the adjustable bending sheath 210 is relatively soft. If there is no sheath mounting seat, directly tightening the screws on the adjustable bending sheath 210 will cause the adjustable bending sheath 210 to deform. In other embodiments, the adjustable bending sheath 210 can also be bonded and fixed with the axial through hole through medical glue.
  • the bending control component 300 is used to control the bending or reset of the bendable portion 211 .
  • the bending control assembly 300 includes a rotating shaft 310 and a control wire 320 .
  • the rotating shaft 310 is rotatably disposed on the base 100.
  • the axis of the rotating shaft 310 is perpendicular to the axis of the adjustable bending sheath 210, and the rotating shaft 310 and the adjustable bending sheath 210 are arranged in a staggered manner.
  • the distal end of the control wire 320 is connected to the bendable part 211 of the adjustable bending sheath 210, and the proximal end of the control wire 320 is connected to the rotating shaft 310 to drive the bendable part to bend or reset under the driving of the rotating shaft 310.
  • the axis of the rotating shaft 310 is parallel to or located in a plane defined by the bending of the bendable portion 211 of the adjustable bending sheath 210 .
  • the plane formed by bending the bendable portion 211 is coplanar with the paper surface, and the axis of the rotating shaft 310 is also located on the paper surface.
  • the bending control assembly 300 may also use other structures to drive the bendable portion to bend or reset. For example, this is achieved by driving the gear set and connecting rod structure (such as a parallelogram structure) through the rotating shaft 310 .
  • the bending control assembly 300 also includes a wire winding wheel 330.
  • the wire winding wheel 330 is fixedly sleeved on the rotating shaft 310.
  • One end of the control wire 320 is fixedly connected to the bendable portion of the adjustable bending sheath 210. 211.
  • the other end of the control wire 320 is wound on the wire winding wheel 330.
  • the wire winding wheel 330 When the wire winding wheel 330 is rotated, the wire winding wheel 330 winds the control wire 320 or releases the control wire 320, thereby driving the bendable portion 211 of the wire winding wheel 330 to bend or reset.
  • the wire winding wheel 330 is provided with a receiving groove along its circumferential direction, and the control wire 320 wound on the wire winding wheel 330 is located in the receiving groove.
  • the accommodating groove plays a role in limiting the control wire 320, preventing the control wire 320 from breaking away from the wire winding wheel 330 and causing the conveying equipment to fail.
  • the control wire 320 includes a first control wire 321 and a second control wire 322.
  • the first control wire 321 is used to control the bendable portion 211 to bend toward the first direction
  • the second control wire 322 is used to control the bendable portion 211 to bend in the first direction.
  • the first direction is opposite to the second direction.
  • the first direction is upward and the second direction is downward.
  • the wire winding wheel 330 includes a first wire winding wheel 331 and a second wire winding wheel 332 arranged axially symmetrically along the axis of the adjustable bending sheath 210.
  • the first control wire 321 is wound around the first wire winding wheel 331 along the third direction.
  • the second control wire 322 is wound around the second wire winding wheel 332 in a fourth direction, and the third direction is opposite to the fourth direction.
  • the first wire winding wheel 331 rotates to tighten the first control wire 321
  • the second wire winding wheel 332 releases the second control wire 322, and the bendable portion 211 bends toward the first direction;
  • the first wire winding wheel 331 retracts
  • the first control wire 321 is tightened
  • the second wire winding wheel 332 releases the second control wire 322, and the bendable portion 211 is bent in the second direction, and the changes in the first control wire 321 and the second control wire 322 are equivalent, which can improve
  • the bending control component 300 controls the bending angle of the bendable portion 211 with precision.
  • first wire winding wheel 331 is provided with a first accommodation groove 331a
  • first control wire 321 wound on the first wire winding wheel 331 is located in the first accommodation groove 331a
  • second wire winding wheel 332 is provided with a first accommodation groove 331a.
  • a second receiving groove 332a is provided, and the second control wire 322 wound on the second wire winding wheel 332 is located in the second receiving groove 332a.
  • the adjustable bending sheath 210 is provided with a first control wire channel and a second control wire channel symmetrically arranged along the axial direction for accommodating the first control wire 321 and the second control wire 322 respectively.
  • the near end of 210 is provided with a first window and a second window.
  • the distal end of the first control wire 321 extends proximally from the flexible portion 211 connected thereto along the first control wire channel, passes out of the first window, and is wound around the first wire winding wheel 331 .
  • the distal end of the second control wire 322 extends proximally from the flexible portion 211 connected thereto along the second control wire channel, passes out of the second window, and is wound around the second wire winding wheel 332 .
  • the first control wire channel and the second control wire channel are located in a plane defined by the bending of the bendable portion 211 .
  • the bending control component 300 when the bending control component 300 controls the bending of the bendable portion 211, the bending control component 300 also drives the relative movement between the undulating member 410 and the reducing member 420. In this way, it can be ensured that the motion between the undulating member 410 and the reducing member 420 is correlated with the bending of the bendable portion 211, ensuring that when the bendable portion 211 approaches the preset angle, there is no movement between the undulating member 410 and the reducing member 420. The warning sound sounds to remind the operator.
  • the bending control assembly 300 drives the undulating member 410 to move relative to the reducing member 420 . In other embodiments, the bending control assembly 300 drives the reducing member 420 to move relative to the undulating member 410 .
  • the undulating member 410 includes a undulating column 411
  • the reducing member 420 includes a reducing portion 421
  • the undulating column 411 and the reducing portion 421 are configured to operate when the bendable portion
  • the wave column 411 is adjacent to the variable diameter part 421.
  • the wave column 411 and the variable diameter part 421 Touch to make a warning sound.
  • the undulating member 410 also includes an elastic connecting portion 412.
  • the reducing portion 421 includes a body portion 421a and a protruding portion 421b. There are multiple protruding portions 421b, which are sequentially provided on the body portion 421a, and the body portion 421a.
  • the portion 421a can be adjacent to the wave column 411, and the protruding portion 421b can be in contact with the wave column 411.
  • the connecting portion 412 deforms so that the wave column 411 passes over the protruding portion 421b and restores its shape at the connecting portion 412 At this time, the wave column 411 contacts the other protruding portion 421b and emits a warning sound.
  • the connecting portion 412 is in the shape of a straight rod. In this way, the warning sound can be made clearer during rotation.
  • the connecting portion 412 can also be horn-shaped, and its tip is connected to the wave column 411.
  • the connecting part 412 includes a connecting part main body 412a and an extending part 412b. One end of the extending part 412b is connected to the connecting part main body 412a, and the other end is connected to the wave column 411.
  • the extending part 412b at least partially surrounds the connecting part main body 412a.
  • at least the extension portion 412b is made of elastic material. In this way, the extension portion 412b can squeeze the gap 412c closer to the connecting portion main body 412a under the action of external force, and restore the shape after the force is removed.
  • the connecting portion 412 is configured as a whole in a disk-like shape, that is, the outer edge of the connecting portion body 412a is arc-shaped, and the outer edge of the extension portion 412b is also arc-shaped, and the two can be spliced to form Roughly round in shape.
  • the bending control assembly 300 drives the undulating member 410 and the reducing member 420 to rotate relative to each other.
  • the body portion 421a of the reducing portion 421 of the reducing member 420 has an arc shape. In this way, when the bending control assembly 300 drives the bendable portion 211 to bend, it directly drives the relative rotation between the wave member 410 and the reducing member 420, simplifying the structure and more accurately reflecting the bending amplitude of the bendable portion 211.
  • the bending control assembly 300 drives the undulating member 410 to rotate relative to the reducing member 420 , and the reducing member 420 remains stationary relative to the base 100 . In this way, it is prevented that force is applied to the reducing member 420 during the rotation of the undulating member 410 so that the reducing member 420 is displaced, and when the bendable portion 211 approaches the preset angle, the reducing member 420 is displaced and causes the undulating member 410 and the reducing member to be displaced.
  • the corresponding relationship between the interaction of the member 420 and the bending angle of the bendable portion 211 is misaligned, so that the operator cannot be accurately warned.
  • the undulating member 410 also includes a fixed part 413.
  • the fixed part 413 is fixedly sleeved on the rotating shaft 310.
  • the connecting part 412 is connected to the fixed part 413.
  • the rotating shaft 310 rotates, the fixed part 413 is driven to rotate, thereby driving the connection.
  • the portion 412 and the wave column 411 move relative to the reducing portion 421, thereby emitting a warning sound.
  • the length of the wave column 411 and/or the fixed part 413 in the axial direction of the rotating shaft 310 is greater than the length of the connecting part 412 in the axial direction of the rotating shaft 310 . That is, the length of the wave column 411 in the axial direction of the rotating shaft 310 is greater than the length of the connecting portion 412 in the axial direction of the rotating shaft 310 , or the length of the fixed portion 413 in the axial direction of the rotating shaft 310 is greater than the length of the connecting portion 412 in the axial direction of the rotating shaft 310 .
  • the length, or the length of the wave column 411 and the fixed part 413 in the axial direction of the rotating shaft 310 is greater than the length of the connecting part 412 in the axial direction of the rotating shaft 310 .
  • the length of the wave column 411 and the fixed part 413 in the axial direction of the rotating shaft 310 is greater than the length of the connecting part 412 in the axial direction of the rotating shaft 310 .
  • the reducing member 420 is arc-shaped, the undulating member 410 is located inside the reducing member 420, and the bending control assembly 300 drives the undulating member 410 relative to the reducing member 420.
  • the reducing portion 421 It includes a body part 421a and a protruding part 421b. There are multiple protruding parts 421b and they are arranged on the body part 421a in sequence.
  • the reducing member 420 further includes a smooth portion 422. The body portion 421a is connected to the smooth portion 422.
  • Both the body portion 421a and the smooth portion 422 are arc-shaped, and the diameter of the body portion 421a is equal to the diameter of the smooth portion 422.
  • the reducing member is circular as a whole.
  • the body portion 421a of the reducing portion 421 can be adjacent to the wave column 411, and the protruding portion 421b can be in contact with the wave column 411.
  • the connecting portion 412 deforms so that the wave column 411 passes over the protruding portion 421b.
  • the connecting portion 412 recovers its shape, the wave
  • the pillar 411 contacts the other protruding portion 421b and emits a warning sound.
  • adjacency in this embodiment means that there is a gap between the wave column 413 and the body part 421a, or that the wave column 413 slightly contacts the body part 421a and does not emit sound that causes human ears to perceive/obviously perceive it.
  • the undulating member 410 rotates relative to the reducing member 420, the undulating column 413 faces the smooth part 422 and the reducing part 421.
  • the wave column 413 faces the protruding part 421b, it first contacts a protruding part 421b, and with the relative movement between the wave member 410 and the reducing member 420, the connecting part 412 deforms to make the wave column 413 passes over the protruding part 421b, and when the connecting part 412 recovers its shape, the wave column 413 contacts the other protruding part 421b and emits a warning sound.
  • protruding portion 421b is serrated. In this way, when the wave column 413 passes over a protruding portion 421b, the protruding portion 421b resists the wave column 413, preventing the wave column 413 from being forced to move in the opposite direction of the preset direction, that is, preventing the wave member 410 from rotating, ensuring that the bendable portion The bending of 211 is kept under control to avoid accidents. Further, the protruding portion 421b is provided in an isosceles sawtooth shape. In this way, the resistance to the rotation and gyration of the wave member 410 can be made moderate.
  • the reducing part 421 may include a first reducing part 421c and a second reducing part 421d.
  • the smooth part 422 may include a first smooth part 422a and a second smooth part 422b, wherein the first variable diameter part 421c, the first smooth part 422a, the second variable diameter part 421d and the second smooth part 422b are connected in sequence, and the first The variable diameter portion 421c and the second variable diameter portion 421d are spaced apart.
  • the wave column 413 contacts the protruding part of the first reducing part 421c to emit a warning sound; when the bendable part 211 bends along the second direction and approaches the first preset angle At the second preset angle, the wave column 413 contacts the protruding portion of the second diameter reducing portion 421d to emit a warning sound.
  • the bendable part 211 bends in different directions and approaches the corresponding preset angle, there is a corresponding reducing part that can interact with the wave column 413 to emit a warning sound, ensuring that the operator makes the bendable part 211 face different directions. When bending, there will be a warning sound to remind the operator to bend.
  • first preset angle and the second preset angle are equal.
  • the first variable diameter portion 421c and the second variable diameter portion 421d can be configured symmetrically.
  • the bending control component 300 controls the bendable part 211 to rotate to a preset angle
  • the wave column 413 moves in the preset direction relative to the first variable diameter part 421c.
  • the spacing distance between two adjacent protruding portions of the first reducing portion 421c is set to decrease along the preset direction.
  • the frequency of interaction between the wave column 413 and the protruding portion of the first variable diameter portion 421c is higher, and the frequency of the warning sound is also higher, which can facilitate the operation.
  • the reader clearly realizes that the bendable portion 211 is getting closer to the preset angle.
  • the bending control component 300 controls the bendable portion 211 to rotate to a preset angle
  • the wave column 413 moves in the preset direction relative to the first reducing portion 421c, and the first reducing portion
  • the heights of the plurality of protruding parts 421c are set incrementally along the preset direction.
  • the deformation amplitude of the connecting portion 412 gradually increases due to the increasing height of the protruding portion.
  • the wave column 413 crosses one protruding portion, the wave column 413 is connected to the other protruding portion. The collision of the protruding part becomes stronger, and the warning sound gradually increases, which can make the operator clearly aware that the bendable part 211 is getting closer to the preset angle.
  • the conveying equipment also includes a housing 500, which is used to accommodate the sound warning component 400.
  • the reducing member 420 is disposed on the inner wall of the housing 500 . In this way, the cavity formed by the housing 500 can amplify the warning sound generated when the undulating member 410 and the reducing member 420 interact, so that the operator can hear the warning sound more clearly.
  • the reducing member 420 may be integrally formed with the housing 500 , or may be prepared separately from the housing 500 and then fixed by gluing, welding, or other methods.
  • the conveying equipment is also provided with a handle 600 .
  • the handle 600 is fixedly connected to the rotating shaft 310 and is located outside the housing 500 .
  • the operator can hold the housing 500 and then rotate the first wire winding wheel 331 and the second wire winding wheel 332 by rotating the handle 600, and then use the first control wire 321 or the second control wire 322.
  • the bendable portion 211 is driven to bend in a specific direction. It is understandable that the size of the handle 600 is generally designed to be larger. In this way, the operator exerting a small force on the handle 600 can bring about a large torque to rotate the handle 600, making the operation more labor-saving.
  • the bending control assembly 300 drives the reducing member to rotate relative to the undulating member. Accordingly, the undulating member remains stationary relative to the base 100 .
  • the bending control assembly 300 also includes a connecting piece, which is used to connect the rotating shaft 310 and the reducing member.
  • the undulating member is no longer fixed to the rotating shaft 310 , but is fixed to the base 100 or the housing 500 through the fixing part, so as to remain stationary relative to the base 100 . In this way, when the rotating shaft 310 rotates, the reducing member is driven to rotate through the connecting member.
  • the parts of the undulating element, such as the undulating column, the connecting portion and the reducing element which are similar to those in the above embodiment will not be described again.
  • the bending control assembly 300 drives the relative movement between the undulating member and the reducing member.
  • the body portion of the reducing portion of the reducing member is strip-shaped.
  • the strip-shaped reducing parts reduce the processing difficulty of the reducing parts, thus reducing the conveying equipment. The difficulty of manufacturing the equipment.
  • the wave column 413 is adjacent to the reducing part without contact.
  • the wave column 413 is in contact with the reducing part to issue a warning. sound.
  • there are multiple reducing portions they are arranged spaced apart from each other.
  • the undulating member 410 moves in the preset direction relative to the reducing member 420, and the spacing distance between the two adjacent protruding portions 421a Decrementally set in the preset direction.
  • the bending control assembly 300 controls the bendable portion 211 to rotate to a preset angle, the undulating member 410 moves in the preset direction relative to the reducing member 420, and the heights of the plurality of protruding portions 421a are set incrementally along the preset direction. The relevant content will not be described again.
  • the bending control assembly 300 can drive the reducing member 420 to move relative to the undulating member 410 .
  • the undulating member 410 is configured to remain stationary with the base 100 (for example, fixed on the base 100 through the fixing part 413 or fixed on the housing 500 ), the reducing member 420 is configured to be movable relative to the base 100.
  • the bending control assembly 300 also includes a gear 340 sleeved on the rotating shaft 310. The reducing member 420 and the gear 340 are meshed and connected to form a rack-and-pinion structure.
  • the reducing member 420 and the gear 340 are configured such that when the bendable portion 211 approaches the preset angle under the control of the bending control assembly 300, the reducing member 420 contacts the undulating member 410 driven by the gear 340 to emit a warning sound. Similarities to the above embodiments will not be described again.
  • the moving direction of the reducing member 420 is perpendicular to the direction of the axis of the adjustable bending sheath 210.
  • the reducing portion 430 includes a first reducing portion 421c, a second reducing portion 421d and a first smooth portion. 422a, the first reduced diameter part 421c and the second reduced diameter part 421d are connected through the first smooth part 422a, and the main body parts of the first reduced diameter part 421c and the second reduced diameter part 421d and the first smooth part 422a form a strip 432.
  • a rack tooth 431 is provided on the opposite side of the side where the protruding portion of the strip 432 is provided, and the rack tooth 431 is used to form a meshing relationship with the gear 340 .
  • the undulating member 410 is disposed at the distal end of the reducing member 420, and the undulating column 411 can be adjacent to the strip 432 and can contact the protruding portion. In this way, when the rotating shaft 310 drives the bendable portion 211 to bend, through the meshing relationship between the gear 340 and the rack teeth 431, the reducing member 420 is driven to move relative to the wave member 410, and when the bendable portion 211 approaches the preset angle , the reducing member 420 contacts the undulating member 410 to emit a warning sound.
  • the difference from the embodiment shown in FIG. 13 is that the moving direction of the reducing member 420 is along the axis of the adjustable bending sheath 210 , and the undulating member 410 and the rotating shaft 310 are respectively located on the reducing member 420 .
  • the wave column 411 can be adjacent to the fixed plate 432 and can be in contact with the protruding portion.
  • the bending control assembly 300 can drive the undulating member 410 to move relative to the reducing member.
  • the control assembly 300 also includes a gear 340 sleeved on the rotating shaft 310.
  • the undulating member 410 and the gear 340 are meshed and connected to form a rack-and-pinion structure.
  • the member 410 and the gear 340 are configured such that when the bendable portion 211 approaches the preset angle under the control of the bending control assembly 300, the undulating member 410 is driven by the gear 340 and contacts the reducing member 420 to emit a warning sound. Similarities to the above embodiments will not be described again.
  • the moving direction of the undulating member 410 is perpendicular to the direction of the axis of the adjustable bending sheath 210.
  • the fixed portion 413 of the undulating member 410 is in a strip shape, and is opposite to the side connected to the connecting portion 412.
  • the other side is provided with rack teeth 431 for forming a meshing relationship with the gear 340 .
  • the reducing member 420 is arranged perpendicular to the axis of the adjustable bending sheath 210 and includes a first reducing portion 421c and a second reducing portion 421d.
  • the first reducing portion 421c and the second reducing portion 421d are coaxially arranged.
  • the first reduced diameter portion 421c and the second reduced diameter portion 421d are connected by the first smooth portion 422a.
  • the reducing member 420 is disposed at the distal end of the undulating member 410, and the undulating column 411 may be adjacent to the main body part and may contact the protruding part. In this way, when the rotating shaft 310 drives the bendable portion 211 to bend, through the meshing relationship between the gear 340 and the rack teeth 431, the undulating member 410 is driven to move relative to the reducing member 420, and when the bendable portion 211 approaches the preset angle , the undulating member 410 contacts the reducing member 420 to emit a warning sound.
  • the difference from the embodiment shown in Figure 15 is that the moving direction of the wave member 410 is along the axis of the adjustable bending sheath 210, and the reducing member 420 is also along the direction of the axis of the adjustable bending sheath 210. Disposed, and the rotating shaft 310 is respectively located on one side of the undulating member 410, the undulating column 411 can be adjacent to the fixed plate 432, and can be in contact with the protruding portion. It can be understood that the positions of the undulating member 410 and the reducing member 420 relative to the gear 340 can also be adjusted accordingly.
  • the positions of the undulating member 410 and the reducing member 420 are not specifically limited, as long as the rotating shaft 310 is rotated so that the gear 340 can drive the undulating member 410 to move relative to the reducing member 420 and emit a warning sound.
  • One embodiment of the present application provides a medical system, as shown in Figure 17, including an implanted prosthesis 700 and the above-mentioned delivery device.
  • the implanted prosthesis 700 is detachably connected to the bendable portion 211, or the implanted prosthesis 700 700 is carried on the bendable part 211.
  • this embodiment uses the above-mentioned delivery device to detachably connect or carry the implanted prosthesis 700.
  • the handle 600 is rotated to transport the implanted prosthesis 700 to the desired position, if the bendable portion 211 is close to the preset position, angle, the sound warning component 400 emits a warning sound to remind the operator.
  • the operator can accurately determine the bending degree of the flexible portion 211 without relying on diagnostic equipment such as CT and X-ray, ensuring that the transportation equipment is used within the normal range, improving the safety of the transportation equipment, and preventing medical accidents.
  • the implanted prosthesis 700 may be a valve clip, an artificial valve prosthesis for treating valve regurgitation, a left atrial appendage occluder for preventing possible thromboembolism formed in the left atrial appendage, or a vascular stent for treating vascular stenosis. wait.
  • the valve clamp and the left atrial appendage occluder can be threadedly connected to the flexible part 211.
  • the artificial valve prosthesis and vascular stent can be compressed and mounted on the flexible part 211.
  • the operator detachably connects the mitral valve clip to the flexible part 211, and then The operator then holds the housing 500 and moves the mitral valve clamp toward the desired position.
  • the mitral valve clamp reaches near the atrioventricular orifice, the operator then rotates the handle 600.
  • the wire wheel rotates and the wave member 410 also changes in diameter.
  • the member 420 rotates.
  • the first wire winding wheel 331 tightens the first control wire 321, and the second wire winding wheel 332 releases the second control wire 322.
  • the bendable portion 211 bends toward the first direction. By bending 211, the mitral valve clamp is moved to the desired position.
  • the mitral valve clamp When the mitral valve clamp reaches the expected position, if the bending angle of the bendable portion 211 approaches the preset angle, the undulating member 410 contacts the reducing member 420 and emits a warning sound. In this way, the operator can judge through the warning sound that the bending angle of the bendable part 211 is close to the preset angle, and at the same time stop rotating the handle 600, adjust the attitude of the conveying equipment in time, and re-control the bending of the bendable part 211 to prevent the bendable part 211 from bending. , control wire breakage to avoid damage to the conveying equipment, improve the safety of the conveying equipment, and prevent medical accidents.
  • One embodiment of the present application provides a medical system, as shown in FIG. 18 , including an actuator 800 and the above-mentioned delivery device.
  • the actuator 800 is connected to the flexible part 211.
  • an actuator is a tool that can perform surgical operations on the human body, such as surgical forceps, staplers, surgical scissors, or electrosurgers.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention se rapporte au domaine technique des instruments médicaux, et en particulier, à un dispositif d'administration et à un système médical. Le dispositif d'administration comprend : une base (100) ; un ensemble gaine (200) disposé sur la base (100), comprenant une gaine réglable en flexion (210), l'extrémité proximale de la gaine réglable en flexion (210) étant fixée à la base (100), et l'extrémité distale de la gaine réglable en flexion (210) étant pourvue d'une partie pliable (211) ; un ensemble de commande de réglage de courbure (300) disposé sur la base (100), configuré pour régler la courbure de la partie pliable (211) ; et un ensemble alarme sonore (400), comprenant un élément de fluctuation (410) et un élément irrégulier (420). Lorsque la partie pliable (211) s'approche d'un angle prédéfini, l'élément de fluctuation (410) est en contact avec l'élément irrégulier (420) et émet un son d'alarme, de sorte qu'un opérateur peut déterminer avec précision la courbure de la partie pliable (211), ce qui garantit le fonctionnement normal du dispositif d'administration, améliore la sécurité d'utilisation et prévient les accidents médicaux.
PCT/CN2023/114444 2022-08-24 2023-08-23 Dispositif d'administration et système médical WO2024041570A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202222240440.7U CN218943605U (zh) 2022-08-24 2022-08-24 输送设备及医疗系统
CN202211024156.4 2022-08-24
CN202222240440.7 2022-08-24
CN202211024156.4A CN115531040A (zh) 2022-08-24 2022-08-24 输送设备及医疗系统

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WO2024041570A1 true WO2024041570A1 (fr) 2024-02-29

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CN212308128U (zh) * 2020-05-11 2021-01-08 上海纽脉医疗科技有限公司 一种二尖瓣修复控制手柄及二尖瓣修复设备
CN214181407U (zh) * 2020-09-10 2021-09-14 杭州德柯医疗科技有限公司 可控制鞘管调弯的手柄及介入器械
CN114632252A (zh) * 2020-12-15 2022-06-17 张海军 一种智能导管调弯系统及其制造方法
WO2022142819A1 (fr) * 2020-12-31 2022-07-07 先健科技(深圳)有限公司 Cathéter à courbure réglable
CN115531040A (zh) * 2022-08-24 2022-12-30 应脉医疗科技(上海)有限公司 输送设备及医疗系统
CN218943605U (zh) * 2022-08-24 2023-05-02 应脉医疗科技(上海)有限公司 输送设备及医疗系统

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CN107550602A (zh) * 2017-09-28 2018-01-09 沛嘉医疗科技(苏州)有限公司 一种经导管主动脉瓣输送系统及其使用方法
CN208851537U (zh) * 2018-03-16 2019-05-14 上海形状记忆合金材料有限公司 一种能够显示弯曲角度的可调弯输送鞘管
CN110786966A (zh) * 2019-12-11 2020-02-14 上海纽脉医疗科技有限公司 一种人造瓣膜输送系统
CN110916852A (zh) * 2019-12-12 2020-03-27 上海纽脉医疗科技有限公司 一种外管移动机构及一种瓣膜输送装置
CN212308128U (zh) * 2020-05-11 2021-01-08 上海纽脉医疗科技有限公司 一种二尖瓣修复控制手柄及二尖瓣修复设备
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CN114632252A (zh) * 2020-12-15 2022-06-17 张海军 一种智能导管调弯系统及其制造方法
WO2022142819A1 (fr) * 2020-12-31 2022-07-07 先健科技(深圳)有限公司 Cathéter à courbure réglable
CN115531040A (zh) * 2022-08-24 2022-12-30 应脉医疗科技(上海)有限公司 输送设备及医疗系统
CN218943605U (zh) * 2022-08-24 2023-05-02 应脉医疗科技(上海)有限公司 输送设备及医疗系统

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