WO2021129493A1 - 输送器和管腔器械输送系统 - Google Patents

输送器和管腔器械输送系统 Download PDF

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Publication number
WO2021129493A1
WO2021129493A1 PCT/CN2020/136981 CN2020136981W WO2021129493A1 WO 2021129493 A1 WO2021129493 A1 WO 2021129493A1 CN 2020136981 W CN2020136981 W CN 2020136981W WO 2021129493 A1 WO2021129493 A1 WO 2021129493A1
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WO
WIPO (PCT)
Prior art keywords
tube
sheath
section
delivery sheath
proximal end
Prior art date
Application number
PCT/CN2020/136981
Other languages
English (en)
French (fr)
Inventor
肖本好
张军强
Original Assignee
先健科技(深圳)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
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to EP20905409.7A priority Critical patent/EP4082492A4/en
Priority to US17/779,760 priority patent/US20220409411A1/en
Publication of WO2021129493A1 publication Critical patent/WO2021129493A1/zh

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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
    • A61F2/95—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
    • 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
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the utility model relates to the field of interventional instruments, in particular to a conveyor and a tube cavity instrument delivery system.
  • the interventional treatment method is mainly to transport the vascular stent-loaded conveyor to the pre-designated position of the vascular disease through human puncture, and then release the stent through the withdrawal of the sheath, so that the stent covers the vascular diseased position. So as to achieve the purpose of treating vascular diseases.
  • the use of interventional therapy to treat vascular diseases has the characteristics of low cost, short treatment period and less trauma to the human body, so it has gradually become the mainstream way of treating vascular diseases.
  • Interventional treatment methods have certain requirements for the delivery sheath of the conveyor, which are mainly reflected in the following aspects: (1) The design of the inner diameter of the delivery sheath should be reasonable, so that the stent can be normally installed in the delivery sheath after compression; (2) the delivery sheath The tube outer diameter size design should be reasonable, so that the delivery sheath loaded with the stent can smoothly deliver the stent to the pre-designated position of the disease during the interventional clinical process; (3) The delivery sheath has a certain degree of pushability and flexural resistance to ensure that it can The stent can be smoothly delivered to the pre-designated position of the lesion without breaking or breaking; (4) The delivery sheath should have a certain degree of tensile resistance.
  • the delivery sheath Due to the certain release resistance during the release of the stent, the delivery sheath has A certain degree of stretch resistance can avoid the risk that the stent cannot be released from the sheath after the sheath becomes longer due to the excessive stent release force; (5) Whether the delivery sheath can be smoothly released after the stent is released Withdraw from the body. It can be seen that the performance of various aspects of the delivery sheath plays an important role in the process of vascular stent intervention.
  • the inner and outer diameters are required to be higher.
  • the inner diameter must be large enough to be able to load the compressed stent and other equipment.
  • the smaller its outer diameter the better, which will inevitably lead to a smaller wall thickness of the delivery sheath.
  • a delivery sheath with a smaller wall thickness its pushability, flexural resistance and tensile strength will be reduced, which may adversely affect the smooth progress of interventional surgery.
  • a conveyor includes a sheath core tube, a delivery sheath tube, and an operating handle.
  • the proximal end of the sheath core tube and the proximal end of the delivery sheath are both connected to the operating handle.
  • the delivery sheath and the The sheath core tubes are all hollow tubes, the delivery sheath tube is slidably sleeved on the sheath core tube, the delivery sheath tube and the sheath core tube form a receiving cavity; the delivery sheath tube includes The loading section, the pushing section and the connecting section, the proximal end of the loading section is connected with the distal end of the pushing section, the proximal end of the pushing section is connected with the distal end of the connecting section, and the proximal end of the connecting section Connected to the operating handle, the inner diameter of the loading section is 0.05-1 mm larger than the inner diameter of the pushing section, and the outer diameters of the loading section and the pushing section are equal, and the axial length of the loading section
  • the pushing section includes a first region and a second region axially connected to the first region, the wall thickness of the second region is constant, and the inner diameter of the loading section is larger than that of the The inner diameter of the second area is greater than 0.05-1 mm.
  • the distal end of the first area is connected to the proximal end of the loading section. From the distal end to the proximal end of the first area, the wall thickness of the first area Gradually increase from a value equal to the wall thickness of the loading section to a value equal to the wall thickness of the second region.
  • the delivery sheath tube in a radial direction from inside to outside, includes an inner tube, a middle tube, and an outer tube in sequence.
  • the middle tube is sleeved on the inner tube, and the outer tube The tube is sleeved on the middle tube.
  • the inner tube is a polytetrafluoroethylene tube
  • the middle tube is a stainless steel wire braided mesh tube
  • the outer tube is a Pebax tube.
  • the distal end face of the inner tube is flush with the distal end face of the outer tube, and the distal end face of the intermediate tube is closer to the inner tube than the distal end face of the inner tube The proximal end face.
  • the sheath core tube includes a first inner tube and a second inner tube fixedly connected to the proximal end of the first inner tube, and the outer diameter of the second inner tube is larger than that of the first inner tube.
  • the outer diameter of the inner tube is larger than that of the first inner tube.
  • the transporter further includes a sheath tube connector that is connected to the connecting section of the delivery sheath tube, and the delivery sheath tube is connected to the operating handle through the sheath tube connector .
  • the sheath tube connector includes a connecting portion and a fixing portion connected to the connecting portion, the connecting portion is sleeved on the connecting section, and the outer diameter of the connecting section is larger than the outer diameter of the connecting section.
  • the outer diameter of the pushing section, the fixed part is fixedly connected with the operating handle.
  • the operating handle includes a fixed handle and a movable handle, the proximal ends of the sheath core tube and the delivery sheath both penetrate the fixed handle and the movable handle in the axial direction, and the sheath core
  • the tube is fixedly connected with the fixed handle, and the delivery sheath tube is fixedly connected with the movable handle through the sheath tube joint.
  • a delivery system for a lumen device includes a lumen device and the above-mentioned conveyor, and the lumen device is accommodated in the containing cavity.
  • the inner diameter of the loading section of the delivery sheath of the above-mentioned conveyor is 0.05-1 mm larger than the inner diameter of the pushing section, and the outer diameters of the loading section and the pushing section are the same, that is, increase reasonably without increasing the outer diameter of the delivery sheath
  • the inner diameter of the loading section makes the inner diameter and the outer diameter relatively moderate, which can smoothly realize the loading and delivery of luminal instruments.
  • the axial length of the loading section accounts for 1% to 5% of the total length of the delivery sheath to avoid excessively long axial length of the loading section with a smaller wall thickness, which will affect the pushability and flexural resistance of the delivery sheath. And stretch resistance.
  • Fig. 1 is a schematic structural diagram of a lumen device delivery system according to an embodiment
  • FIG. 2 is a schematic diagram of the structure of a conveyor according to an embodiment
  • Figure 3 is a partial enlarged view of Figure 1;
  • Figure 4 is a schematic diagram of a state in which a delivery sheath and a sheath joint are connected according to an embodiment
  • Fig. 5 is a schematic diagram showing a connection state of a delivery sheath and a sheath connector according to another embodiment
  • Fig. 6 is a schematic diagram of a partial cross-sectional structure of a loading section of a delivery sheath according to an embodiment.
  • distal end is defined as the end far away from the operator during the operation
  • proximal end is defined as the end close to the operator during the operation.
  • Axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device
  • radial refers to the direction perpendicular to the above-mentioned axis.
  • a luminal instrument delivery system 100 includes a luminal instrument 1 and a conveyor 2.
  • the lumen device 1 is a blood vessel stent.
  • the lumen device 1 is a stent graft, and the stent graft includes a support frame and a membrane covering the support frame. The covering film covers the support frame to form a circumferentially closed lumen structure.
  • the luminal device 1 is a bare stent, that is, it only includes a support frame and does not include a membrane.
  • the conveyor 2 includes a sheath core tube 20, a delivery sheath tube 30 and an operating handle 40. Both the sheath core tube 20 and the delivery sheath tube 30 are hollow tubes.
  • the delivery sheath 30 is sleeved on the sheath core tube 20 and the delivery sheath 30 and the sheath core tube 20 are coaxial.
  • the delivery sheath tube 30 is axially slidable relative to the sheath core tube 20.
  • the delivery sheath 30 and the sheath core tube 20 enclose a ring-shaped receiving cavity 50, and the compressed lumen device 1 is received in the ring-shaped receiving cavity 50, as shown in FIG. 3.
  • the sheath core tube 20 includes a first inner tube 21 and a second inner tube 22 fixedly connected to the proximal end of the first inner tube 21. Both the first inner tube 21 and the second inner tube 22 are hollow tubular members.
  • the first inner tube 21 is a tubular structure with an equal outer diameter
  • the second inner tube 22 is also a tubular structure with an equal outer diameter
  • the outer diameter of the first inner tube 21 is smaller than the outer diameter of the second inner tube 22.
  • the inner diameter of the first inner tube 21 and the inner diameter of the second inner tube 22 are equal.
  • the sheath core tube 20 can be formed by integral molding.
  • the inner diameter of the first inner tube 21 is smaller than the inner diameter of the second inner tube 22, and the second inner tube 22 is sleeved and fixed to the proximal end of the first inner tube 21.
  • the distal end of the second inner tube 22 and the proximal end of the first inner tube 21 can be connected by bonding, welding, or the like.
  • the sheath core tube 20 includes a second inner tube 22 with a larger outer diameter, so that the second inner tube 22 can form a better support for the delivery sheath 30 in the area of the delivery sheath 30 that is not covered by the lumen device 1, which is beneficial to Prevent the delivery sheath 30 from bending.
  • the delivery sheath 30 includes a loading section 31, a pushing section 32, and a connecting section 33 that are axially connected in sequence.
  • the proximal end of the loading section 31 is connected with the distal end of the pushing section 32
  • the proximal end of the pushing section 32 is connected with the distal end of the connecting section 33
  • the proximal end of the connecting section 33 is connected with the operating handle 40 (not shown in FIG. 4).
  • the loading section 31 is a hollow tube with a constant inner diameter and a constant outer diameter.
  • the inner diameter of the loading section 31 is 0.05-1 mm larger than the inner diameter of the pushing section 32, and the outer diameters of the loading section 31 and the pushing section 32 are equal.
  • the axial length of the loading section 31 accounts for 1% to 5% of the total length of the delivery sheath 30.
  • the axial length of the loading section 31 with a smaller wall thickness only accounts for 1% to 5% of the total length of the delivery sheath 30, which is beneficial to avoid the delivery sheath 30 from being broken or broken during the delivery process.
  • the release force of the lumen device 1 is too large, which causes the delivery sheath 30 to be subjected to a relatively large tension and becomes longer, resulting in the failure of the lumen device 1 to be released.
  • the pushing section 32 is a hollow tube with a constant inner diameter and outer diameter.
  • the pushing section 32 includes a first area A and a second area B axially connected to the first area A.
  • the distal end of the first area A is connected to the proximal end of the loading section 31, and the proximal end of the first area A is connected to the distal end of the second area B.
  • the wall thickness of the second area B is constant, and the inner diameter of the loading section 31 is larger than the inner diameter of the second area B by 0.05-1 mm. Extending axially from the distal end to the proximal end of the first area A, the wall thickness of this area gradually increases, and gradually increases from a value equal to the wall thickness of the loading section 31 to a value equal to the wall thickness of the second area B Numerical value.
  • the axial length of the first area A is very small, about 3-10 mm, so it will not affect the overall pushability, flexural resistance and stretch resistance of the push section 32.
  • the inner diameter of the connecting section 33 is equal to the inner diameter of the pushing section 32.
  • the outer diameter of the connecting section 33 is equal to the outer diameter of the pushing section 32 (as shown in FIG. 4) or the outer diameter of the connecting section 33 is larger than the outer diameter of the pushing section 32 (as shown in FIG. 5).
  • the outer diameter of the connecting section 33 is equal to the outer diameter of the pushing section 32, which makes the processing more convenient.
  • the delivery sheath 30 may be an integral structure, that is, the delivery sheath 30 including the loading section 31, the pushing section 32, and the connecting section 33 is integrally formed. Alternatively, the loading section 31, the pushing section 32 and the connecting section 33 are axially connected in order to form the delivery sheath 30.
  • the pushing section 32 includes a first area A with a gradual wall thickness, so that the wall thickness of the loading section 31 and the pushing section 32 are smoothly transitioned.
  • This design on the one hand, is more convenient for processing; on the other hand, it can avoid sharp changes in stress. Therefore, it is possible to avoid the risk of breaking the delivery sheath 30 during the process of entering a complicated blood vessel due to stress concentration at the bent position.
  • the delivery sheath 30 in the radial direction from the inside to the outside (from the inner cavity to the outer wall), the delivery sheath 30 includes an inner tube 301, a middle tube 302, and an outer tube 303 in turn.
  • the middle tube 302 is sleeved on the inner tube 301
  • the outer tube 303 is sleeved on the middle tube 302.
  • the inner tube 301, the middle tube 302, and the outer tube 303 are closely attached to each other to form a dense sheath wall.
  • the three are melted into one body by means of hot melting.
  • the inner tube 301 is a polytetrafluoroethylene (PTFE) tube
  • the middle tube 302 is a stainless steel wire braided mesh tube
  • the outer tube 303 is a Pebax tube.
  • the three materials respectively form the inner tube 301, the middle tube 302, and the outer tube 303, and the loading section 31 is reasonably set to account for 1% to 5% of the total axial length of the delivery sheath 30.
  • the delivery sheath 30 is made as a whole It has sufficient structural strength, sufficient push performance, flexural resistance and stretch resistance to ensure smooth delivery and release, and improve the success rate of surgery. At the same time, it can also avoid that the structural strength of the inner tube 301, the middle tube 302, and the outer tube 303 after being integrated into one body is too high, which makes it difficult for the delivery sheath 30 to pass through the curved blood vessel part.
  • the distal end 3012 of the inner tube 301 and the distal end 3032 of the outer tube 303 are flush, the distal end 3022 of the middle tube 302 is closer to the proximal end of the inner tube 301 than the distal end 3012 of the inner tube 301
  • the end surface (the proximal end surface of the inner tube 301 is not shown in FIG. 6).
  • the proximal end surface of the inner tube 301, the proximal end surface of the outer tube 303, and the proximal end surface of the intermediate tube 302 are flush.
  • the conveyor 2 further includes a guide head 10, and the guide head 10 is a tapered hollow cavity structure with open ends.
  • the guiding head 10 is preferably a TIP guiding head, so that the guiding head 10 is more flexible.
  • the distal end of the sheath core tube 20 extends from the proximal open end of the guide head 10 into the guide head 10 and is fixedly connected to the guide head 10, and the cavity of the sheath core tube 20 communicates with the cavity of the guide head 10 to form a guide wire Channel to ensure that the transporter 2 loaded with the lumen device 1 can smoothly enter the blood vessel under the guidance of the guide wire.
  • the first inner tube 21 of the sheath core tube 20 is fixedly connected to the guide head 10.
  • the distal end of the delivery sheath 30 in the loaded state, is sleeved on the guide head 10, and the distal end 3022 of the intermediate tube 302 is larger than the distal end 3012 of the inner tube 301. It is closer to the proximal end surface of the inner tube 301, so that the distal end of the delivery sheath 30 is relatively soft.
  • the rigidity of the guide head 10 is not significantly increased to facilitate the guiding The head 10 smoothly passes through the tortuous blood vessel path.
  • the distance between the distal end surface 3012 of the inner tube 301 and the distal end surface 3022 of the intermediate tube 302 is 1 to 3 millimeters.
  • the delivery sheath 30 further includes a marking ring 304, the marking ring 304 is sleeved on the distal end of the middle tube 304, and the marking ring 304 is embedded in the wall of the outer tube 303.
  • the material of the marking ring 304 is a material with good visibility under medical imaging equipment such as DSA.
  • the marking ring 304 is provided to enhance the visibility of the delivery sheath 30.
  • the distal end surface 3042 of the marking ring 304 is flush with the distal end surface 3022 of the intermediate tube 302.
  • the distal end surface 3042 of the marking ring 304 is flush with the distal end surface 3022 of the intermediate tube 302, so that the marking ring 304 is provided to enhance visibility without increasing the rigidity of the distal end of the delivery sheath 30, so that when the delivery sheath 30 When the distal end of is sleeved on the guide head 10, the rigidity of the guide head 10 is not significantly increased.
  • the operating handle 40 includes a fixed handle 41 and a movable handle 42.
  • the fixed handle 41 has a first accommodating cavity 412 with openings at both ends, and the openings at the two ends are axially opposite.
  • the movable handle 42 has a second accommodating cavity 422 with openings at both ends, and the openings at the two ends are axially opposite.
  • the proximal ends of the sheath core tube 20 and the delivery sheath tube 30 both penetrate the fixed handle 41 and the movable handle 42 along the axial direction, and the sheath core tube 20 is fixedly connected with the fixed handle 41, and the delivery sheath 30 and the movable handle 42 are fixedly connected.
  • the movable handle 42 can slide axially relative to the fixed handle 41 and drive the delivery sheath 30 to slide axially accordingly.
  • the movable handle 42 drives the delivery sheath 30 to slide axially away from the fixed handle 41 to release the lumen device 1.
  • the delivery sheath 30 is connected to the operating handle 40 through the sheath connector 60.
  • the delivery sheath 30 is fixedly connected to the movable handle 42 through the sheath connector 60.
  • the sheath tube joint 60 includes a connecting portion 61 and a fixing portion 62 connected to the connecting portion 61.
  • the connecting portion 61 has an inner cavity, the connecting portion 61 is sleeved on the connecting section 33 of the delivery sheath 30, and the fixed portion 62 is connected with the inner wall of the movable handle 42 to realize a fixed connection between the delivery sheath 30 and the movable handle 42.
  • connection between the fixed portion 62 and the inner wall of the movable handle 42 refers to a direct connection or an indirect connection.
  • a clamping plate fixed on the inner wall of the movable handle 42 may be provided, and the fixing portion 62 is fixedly connected to the clamping plate.
  • the connecting portion 61 has a hollow cylindrical structure
  • the fixing portion 62 has two sheet-like structures.
  • the two sheet structures are symmetrically arranged on the side surface of the connecting portion 61 with the central axis of the connecting portion 61 as the symmetry axis, and extend from the side surface of the connecting portion 61 in a direction away from the side surface.
  • the connecting portion 61 is sleeved on the connecting section 33 of the delivery sheath 30 and is fixedly connected to the connecting section 33.
  • the fixed connection methods include, but are not limited to, glue bonding, ultrasonic welding, threaded connection, injection molding connection and other connection methods mastered by those skilled in the art.
  • the outer diameter of the connecting section 33 is larger than the outer diameter of the pushing section 32, which is beneficial to the connecting portion 61 of the sheath tube joint 60 and the connecting section 33 to be fully combined, which can increase the degree of fixed connection between the two, so that the sheath tube joint 60 and the delivery
  • the connecting force of the sheath tube 30 is increased, so as to avoid the risk of the sheath tube connector 60 and the delivery sheath tube 30 being pulled off if the release resistance is too large.
  • the luminal instrument 1 When assembling the above-mentioned luminal instrument delivery system 100, the luminal instrument 1 is compressed and loaded into the accommodating cavity 50 enclosed by the sheath core tube 20 and the delivery sheath 30, so that the luminal instrument 1 is loaded on the conveyor 2 in.
  • the distal end surface of the delivery sheath 30 abuts against the proximal end surface of the guide head 10 or the distal end of the delivery sheath 30 is sleeved on the proximal end of the guide head 10.
  • the lumen device 1 (as shown in FIG. 1) is bound by the delivery sheath 30.
  • the movable handle 42 axially slides toward the proximal end to drive the delivery sheath 30 to slide axially toward the proximal end to release the luminal instrument 1.
  • the inner diameter of the loading section 31 of the delivery sheath 30 of the aforementioned conveyor 2 is 0.05-1 mm larger than the inner diameter of the pushing section 32, and the outer diameters of the loading section 31 and the pushing section 32 are the same, that is, the outer diameter of the delivery sheath 30 is not increased Under the premise of, the inner diameter of the loading section 31 is reasonably increased to make the inner diameter and outer diameter relatively moderate, so that the equipment can be loaded and transported smoothly.
  • the loading section 31 occupies 1% to 5% of the total axial length of the delivery sheath 30, so as to prevent the axial length of the loading section 31 with a smaller wall thickness from being too long and affecting the pushability and flexural resistance of the delivery sheath 30 And stretch resistance.
  • the above-mentioned conveyor 2 can be applied to the lumen device 1 with a larger radial size after compression, and is more suitable for the lumen device 1 with a larger radial size after compression, and has good adaptability.
  • the use of the luminal instrument delivery system 100 to treat vascular diseases is beneficial to the smooth progress of the implantation operation, and at the same time, avoids the failure of the operation to cause secondary trauma to the patient.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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Abstract

一种输送器（2）和管腔器械输送系统（100），输送器（2）包括鞘芯管（20）、输送鞘管（30）和操作手柄（40），鞘芯管（20）的近端和输送鞘管（30）的近端均与操作手柄（40）相连，输送鞘管（30）和鞘芯管（20）均为中空管，输送鞘管（30）可轴向滑动地套设于鞘芯管（20）上，输送鞘管（30）和鞘芯管（20）形成收容腔（50）；输送鞘管（30）包括装载段（31）、推送段（32）和连接段（33），装载段（31）的近端与推送段（32）的远端相连，推送段（32）的近端与连接段（33）的远端相连，连接段（33）的近端与操作手柄（40）相连，装载段（31）的内径比推送段（32）的内径大0.05～1毫米，且装载段（31）和推送段（32）的外径相等，装载段（31）的轴向长度占输送鞘管（30）的总长度的百分比为1％～5％。该输送器（2）的输送鞘管（30）的内径和外径较为适中，且其推送性、抗折能力和抗拉伸能力较好。

Description

输送器和管腔器械输送系统 技术领域
本实用新型涉及介入式器械领域，特别是涉及一种输送器和管腔器械输送系统。
背景技术
本部分提供的仅仅是与本公开相关的背景信息，其并不必然是现有技术。
对于血管类疾病来说，介入治疗方式主要为将装载有血管支架的输送器通过人体穿刺方式输送到血管病变预指定位置，然后通过鞘管后撤实现支架释放，进而使支架覆盖血管病变位置，从而达到治疗血管疾病的目的。采用介入治疗方式治疗血管疾病具有成本低、治疗周期短及对人体创伤小的特点，因而逐渐成为治疗血管疾病的主流方式。
介入治疗方式对输送器的输送鞘管具有一定要求，主要体现在以下方面：(1)输送鞘管内径尺寸设计应合理，便于支架在压缩后能够正常装进输送鞘管内；(2)输送鞘管外径尺寸设计应合理，便于介入临床过程中装载有支架的输送鞘管能够顺利将支架输送到病变预指定位置；(3)输送鞘管具有一定的推送性和抗折能力，以保证能够将支架顺利输送到病变预指定位置并且不会出现打折或折断现象；(4)输送鞘管应具有一定程度的抗拉伸能力，由于支架释放过程中存在一定的释放阻力，输送鞘管的具有一定程度的抗拉伸能力可以避免因支架释放力过大造成鞘管受较大拉力变长后支架无法从鞘管里面释放出来的风险；(5)输送鞘管在支架释放完成后能否顺利撤出体外。由此可见输送鞘管的各个方面的性能是否优良在血管支架介入治疗过程中起着重要作用。
对于压缩后径向尺寸较大的支架类产品的输送器，其内外径尺寸要求较高，首先，其内径必须足够大以能够装载压缩后的支架等器械。并且，为了能够保证顺利进入血管，在保持其内径不变的情况下，其外径尺寸越小越好，这必然导致输送鞘管的壁厚尺寸较小。然而，对于壁厚尺寸较小的输送鞘管，其推送性、抗折能力和抗拉伸强度将会有所降低，这可能会对介入手术的顺利进行产 生不良影响。
实用新型内容
基于此，有必要提供一种输送器，该输送器的输送鞘管的内径和外径较为适中，且其推送性、抗折能力和抗拉伸能力较好。
一种输送器，包括鞘芯管、输送鞘管和操作手柄，所述鞘芯管的近端和所述输送鞘管的近端均与所述操作手柄相连，所述输送鞘管和所述鞘芯管均为中空管，所述输送鞘管可轴向滑动地套设于所述鞘芯管上，所述输送鞘管和所述鞘芯管形成收容腔；所述输送鞘管包括装载段、推送段和连接段，所述装载段的近端与所述推送段的远端相连，所述推送段的近端与所述连接段的远端相连，所述连接段的近端与所述操作手柄相连，所述装载段的内径比所述推送段的内径大0.05～1毫米，且所述装载段和所述推送段的外径相等，所述装载段的轴向长度占所述输送鞘管的总长度的百分比为1％～5％。
在其中一个实施例中，所述推送段包括第一区域及与所述第一区域轴向相连的第二区域，所述第二区域的壁厚恒定，且所述装载段的内径比所述第二区域的内径大0.05～1毫米，所述第一区域的远端与所述装载段的近端相连，从所述第一区域的远端至近端，所述第一区域的壁厚从与与所述装载段的壁厚相等的数值逐渐增大至与所述第二区域的壁厚相等的数值。
在其中一个实施例中，沿径向按从里向外的方向，所述输送鞘管依次包括内管、中间管和外管，所述中间管套设于所述内管上，所述外管套设于所述中间管上。
在其中一个实施例中，所述内管为聚四氟乙烯管，所述中间管为不锈钢丝编织网管，所述外管为Pebax管。
在其中一个实施例中，所述内管的远端端面和所述外管的远端端面平齐，所述中间管的远端端面较所述内管的远端端面更靠近所述内管的近端端面。
在其中一个实施例中，所述鞘芯管包括第一内管及与所述第一内管的近端固定连接的第二内管，所述第二内管的外径大于所述第一内管的外径。
在其中一个实施例中，所述输送器还包括鞘管接头，所述鞘管接头与所述 输送鞘管的连接段相连，所述输送鞘管通过所述鞘管接头与所述操作手柄相连。
在其中一个实施例中，所述鞘管接头包括连接部及与所述连接部相连的固定部，所述连接部套设于所述连接段上，且所述连接段的外径大于所述推送段的外径，所述固定部与所述操作手柄固定连接。
在其中一个实施例中，所述操作手柄包括固定手柄和活动手柄，所述鞘芯管和输送鞘管的近端均沿轴向穿入所述固定手柄和活动手柄中，且所述鞘芯管与所述固定手柄固定连接，所述输送鞘管通过所述鞘管接头与所述活动手柄固定连接。
一种管腔器械输送系统，包括管腔器械和上述输送器，所述管腔器械收容于所述收容腔中。
上述输送器的输送鞘管的装载段的内径比推送段的内径大0.05～1毫米，且装载段和推送段的外径相同，即不增加输送鞘管的外径的前提下合理地增大装载段的内径，使内径和外径较为适中，能够顺利实现管腔器械的装载和输送。并且，装载段的轴向长度占输送鞘管的总长度的百分比为1％～5％，避免壁厚较小的装载段的轴向长度过长而影响输送鞘管的推送性、抗折能力和抗拉伸能力。
附图说明
图1为一实施方式的管腔器械输送系统的结构示意图；
图2为一实施方式的输送器的结构示意图；
图3为图1的局部放大图；
图4为一实施方式的输送鞘管与鞘管接头连接的状态示意图；
图5为另一实施方式的输送鞘管与鞘管接头连接的状态示意图；
图6为一实施方式的输送鞘管的装载段的局部剖面结构示意图。
具体实施方式
为使本实用新型的上述目的、特征和优点能够更加明显易懂，下面结合附图对本实用新型的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本实用新型。但是本实用新型能够以很多不同于在此描 述的其它方式来实施，本领域技术人员可以在不违背本实用新型内涵的情况下做类似改进，因此本实用新型不受下面公开的具体实施的限制。
除非另有定义，本文所使用的所有的技术和科学术语与属于本实用新型的技术领域的技术人员通常理解的含义相同。本文中在本实用新型的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本实用新型。
在介入医疗器械领域，定义“远端”为手术过程中远离操作者的一端，定义“近端”为手术过程中靠近操作者的一端。“轴向”指平行于医疗器械远端中心和近端中心连线的方向，“径向”指垂直于上述轴向的方向。
请参阅图1，一实施方式的管腔器械输送系统100，包括管腔器械1和输送器2。
在一实施方式中，管腔器械1为血管支架。在一实施方式中，管腔器械1为覆膜支架，覆膜支架包括支撑骨架和覆盖支撑骨架的覆膜。覆膜包覆在支撑骨架上形成周向封闭的管腔结构。在一实施方式中，管腔器械1为裸支架，即仅包括支撑骨架，不包括覆膜。
请一并参阅图1和图2，输送器2包括鞘芯管20、输送鞘管30和操作手柄40。鞘芯管20和输送鞘管30均为中空管。输送鞘管30套设于鞘芯管20上且输送鞘管30和鞘芯管20同轴。并且，输送鞘管30相对鞘芯管20可轴向滑动。输送鞘管30和鞘芯管20围成环形的收容腔50，压缩后的管腔器械1收容于环形的收容腔50中，如图3所示。
在一实施方式中，请再次参阅图2，鞘芯管20包括第一内管21及与第一内管21的近端固定连接的第二内管22。第一内管21和第二内管22均为中空的管状构件。第一内管21为等外径的管状结构，第二内管22也为等外径的管状结构，且第一内管21的外径小于第二内管22的外径。在一实施方式中，第一内管21的内径和第二内管22的内径相等。这种实施方式中，可以通过一体成型的方式形成鞘芯管20。在另外的实施方式中，第一内管21的内径小于第二内管22的内径，第二内管22套设并固定于第一内管21的近端。可以通过粘接、焊接等方式将第二内管22远端与第一内管21的近端相连。
鞘芯管20包括外径较大的第二内管22，使得第二内管22在输送鞘管30的 未覆盖管腔器械1的区域能够对输送鞘管30形成较好的支撑，有利于防止输送鞘管30弯折。
请参阅图4，输送鞘管30包括依次轴向相连的装载段31、推送段32和连接段33。其中，装载段31的近端与推送段32的远端相连，推送段32的近端与连接段33的远端相连，连接段33的近端与操作手柄40(图4未示)相连。
装载段31为内径和外径恒定的中空管。装载段31的内径比推送段32的内径大0.05～1毫米，并且装载段31和推送段32的外径相等。装载段31的轴向长度占输送鞘管30的总长度的百分比为1％～5％。壁厚较小的装载段31的轴向长度仅占输送鞘管30的总长度的1％～5％，有利于避免在输送过程中输送鞘管30打折或折断。并且，避免在释放过程中，管腔器械1的释放力过大造成输送鞘管30受较大拉力变长后而导致无法释放管腔器械1的后果。
在一实施方式中，推送段32为内径和外径恒定的中空管。
在另一实施方式中，请参阅图4，推送段32包括第一区域A和与第一区域A轴向相连的第二区域B。第一区域A的远端与装载段31的近端连接，第一区域A的近端与第二区域B的远端连接。第二区域B的壁厚恒定，且装载段31的内径比第二区域B的内径大0.05～1毫米。从第一区域A的远端轴向延伸至近端，该区域的壁厚逐渐增大，且从与装载段31的壁厚相等的数值逐渐增大至与第二区域B的壁厚相等的数值。第一区域A的轴向长度很小，约为3～10毫米，因而不会影响推送段32整体的推送性、抗折能力和抗拉伸能力。
连接段33的内径与推送段32内径的相等。连接段33的外径与推送段32的外径相等(如图4)或者连接段33的外径大于推送段32的外径(如图5)。连接段33的外径与推送段32的外径相等，使得加工的较为方便。输送鞘管30可以为一体式结构，即一体成型形成包括装载段31、推送段32和连接段33的输送鞘管30。或者，装载段31、推送段32和连接段33按顺序轴向相连形成输送鞘管30。
推送段32包括壁厚渐变的第一区域A，使得装载段31的壁厚与推送段32的壁厚平滑过渡，这样设计，一方面，加工较为方便；另一方面，能够避免应力急剧变化，因而能避免在弯曲的位置容易产生应力集中而造成输送鞘管30在 进入复杂血管过程中产生的折断风险。
请参阅图6，沿径向按从里向外(从内腔至外壁)的方向，输送鞘管30依次包括内管301、中间管302和外管303，中间管302套设于内管301上，外管303套设于中间管302上。并且，内管301、中间管302和外管303三者紧密贴合，形成密实的鞘管壁。例如，内管301、中间管302和外管303按上述方式布置后，采用热熔的方式使三者熔为一体。
在一实施方式中，内管301为聚四氟乙烯(PTFE)管，中间管302为不锈钢丝编织网管，外管303为Pebax管。三种材料分别形成内管301、中间管302和外管303，并合理地设置装载段31占输送鞘管30的总轴向长度的1％～5％，一方面，使输送鞘管30整体具有足够的结构强度，具有足够的推送性能、抗折能力和抗拉伸能力，以保证输送和释放顺畅，提高手术成功率。同时，还可以避免内管301、中间管302和外管303融合为一体后的结构强度过高而导致输送鞘管30难以通过弯曲的血管部位。
请对照图6，内管301的远端端面3012和外管303的远端端面3032平齐，中间管302的远端端面3022较内管301的远端端面3012更靠近内管301的近端端面(图6未示出内管301的近端端面)。内管301的近端端面、外管303的近端端面和中间管302的近端端面平齐。
进一步地，请再次参阅图1和图2，输送器2还包括导向头10，导向头10为两端开口的锥形中空腔体结构。导向头10优选为TIP导向头，以使导向头10的柔顺性较好。鞘芯管20的远端从导向头10的近端开口端伸入导向头10中并与导向头10固定连接，且鞘芯管20的空腔与导向头10的腔体连通而形成导丝通道，以确保装载有管腔器械1的输送器2在导丝的引导下可以顺利地进入血管。具体地，鞘芯管20的第一内管21与导向头10固定连接。
为保证装载的稳定性，在一实施方式中，在装载状态，输送鞘管30的远端部分套设于导向头10上，中间管302的远端端面3022较内管301的远端端面3012更靠近内管301的近端端面，使得输送鞘管30的远端相对较为柔软，当输送鞘管30的远端套设于导向头10上，不显著增加导向头10的刚性，以利于导向头10顺利经过弯曲的血管路径。
在一实施方式中，内管301的远端端面3012与中间管302的远端端面3022之间的距离为1～3毫米。
在一实施方式中，如图6所示，输送鞘管30还包括标记环304，标记环304套设于中间管304的远端，并且，标记环304嵌入外管303的壁中。标记环304的材料为在DSA等医学影像设备下可视性较好的材料。设置标记环304，有利于增强输送鞘管30的可视性。在一实施方式中，标记环304的远端端面3042与中间管302的远端端面3022平齐。标记环304的远端端面3042与中间管302的远端端面3022平齐，使得设置标记环304以增强可视性，但又不增加输送鞘管30远端的刚性，使得当输送鞘管30的远端套设于导向头10上时，不显著增加导向头10的刚性。
请回到图1和图2，操作手柄40包括固定手柄41和活动手柄42。固定手柄41具有两端开口的第一容置腔412，两端的开口轴向相对。活动手柄42具有两端开口的第二容置腔422，两端的开口轴向相对。
鞘芯管20和输送鞘管30的近端均沿轴向穿入固定手柄41和活动手柄42中，且鞘芯管20与固定手柄41固定连接，输送鞘管30与活动手柄42固定连接。活动手柄42可相对固定手柄41轴向滑动，并带动输送鞘管30相应地轴向滑动。活动手柄42带动输送鞘管30向远离固定手柄41的方向轴向滑动以释放管腔器械1。
请参阅图1，在一实施方式中，输送鞘管30通过鞘管接头60与操作手柄40相连。具体地，输送鞘管30通过鞘管接头60与活动手柄42固定相连。如图4和图5，鞘管接头60包括连接部61及与连接部61相连的固定部62。连接部61具有内腔，连接部61套设于输送鞘管30的连接段33上，固定部62与活动手柄42的内壁相连，以实现输送鞘管30与活动手柄42固定连接。需要说明的是，固定部62与活动手柄42的内壁相连是指直接相连或间接相连。例如，可以设置固定于活动手柄42的内壁上的卡接板，固定部62与卡接板固定相连。
在一更具体的实施方式中，连接部61为中空的圆柱结构，固定部62为两个片状结构。两个片状结构以连接部61的中心轴线为对称轴，对称设置地设置于连接部61的侧面上，并从连接部61的侧面向远离该侧面的方向延伸。
连接部61套设于输送鞘管30的连接段33上，并与连接段33固定连接。固定连接的方式包括但不限于胶水粘结、超声波焊接、螺纹连接和注塑连接等其他本领域技术人员掌握的连接方式。连接段33的外径大于推送段32的外径，有利于鞘管接头60的连接部61与连接段33能够充分结合，可以增加两者之间的固定连接程度，使鞘管接头60和输送鞘管30的连接力增强，避免在释放阻力过大情况下鞘管接头60和输送鞘管30发生被拉脱的风险。
当组装上述管腔器械输送系统100时，将管腔器械1压缩后装入鞘芯管20和输送鞘管30所围成的容置腔50中，从而将管腔器械1装载于输送器2中。在装载状态下，输送鞘管30的远端端面与导向头10的近端端面抵接或输送鞘管30的远端套设在导向头10的近端。此时，管腔器械1(如图1所示)被输送鞘管30所束缚。
在手术过程中，当将管腔器械1输送至病变部位后，通过使活动手柄42向近端轴向滑动时带动输送鞘管30向近端轴向滑动以释放管腔器械1。
上述输送器2的输送鞘管30的装载段31的内径比推送段32的内径大0.05～1毫米，且装载段31和推送段32的外径相同，即不增加输送鞘管30的外径的前提下合理地增大装载段31的内径，使内径和外径较为适中，能够顺利实现器械的装载和输送。并且，装载段31占输送鞘管30的总轴向长度的1％～5％，避免壁厚较小的装载段31的轴向长度过长而影响输送鞘管30的推送性、抗折能力和抗拉伸能力。
上述输送器2能够适用于压缩后径向尺寸较大的管腔器械1，更能适用于用于压缩后径向尺寸较大的管腔器械1，适应性好。
因此，使用该管腔器械输送系统100治疗血管疾病，有利于植入手术顺利进行，同时避免手术故障而对患者造成二次创伤。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本实用新型的几种实施方式，其描述较为具体和 详细，但并不能因此而理解为对实用新型专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本实用新型构思的前提下，还可以做出若干变形和改进，这些都属于本实用新型的保护范围。因此，本实用新型专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种输送器，其特征在于，包括鞘芯管、输送鞘管和操作手柄，所述鞘芯管的近端和所述输送鞘管的近端均与所述操作手柄相连，所述输送鞘管和所述鞘芯管均为中空管，所述输送鞘管可轴向滑动地套设于所述鞘芯管上，所述输送鞘管和所述鞘芯管形成收容腔；所述输送鞘管包括装载段、推送段和连接段，所述装载段的近端与所述推送段的远端相连，所述推送段的近端与所述连接段的远端相连，所述连接段的近端与所述操作手柄相连，所述装载段的内径比所述推送段的内径大0.05～1毫米，且所述装载段和所述推送段的外径相等，所述装载段的轴向长度占所述输送鞘管的总长度的百分比为1％～5％。
  2. 根据权利要求1所述的输送器，其特征在于，所述推送段包括第一区域及与所述第一区域轴向相连的第二区域，所述第二区域的壁厚恒定，且所述装载段的内径比所述第二区域的内径大0.05～1毫米，所述第一区域的远端与所述装载段的近端相连，从所述第一区域的远端至近端，所述第一区域的壁厚从与与所述装载段的壁厚相等的数值逐渐增大至与所述第二区域的壁厚相等的数值。
  3. 根据权利要求1所述的输送器，其特征在于，沿径向按从里向外的方向，所述输送鞘管依次包括内管、中间管和外管，所述中间管套设于所述内管上，所述外管套设于所述中间管上。
  4. 根据权利要求3所述的输送器，其特征在于，所述内管为聚四氟乙烯管，所述中间管为不锈钢丝编织网管，所述外管为Pebax管。
  5. 根据权利要求3所述的输送器，其特征在于，所述内管的远端端面和所述外管的远端端面平齐，所述中间管的远端端面较所述内管的远端端面更靠近所述内管的近端端面。
  6. 根据权利要求1所述的输送器，其特征在于，所述鞘芯管包括第一内管及与所述第一内管的近端固定连接的第二内管，所述第二内管的外径大于所述第一内管的外径。
  7. 根据权利要求1所述的输送器，其特征在于，所述输送器还包括鞘管接头，所述鞘管接头与所述输送鞘管的连接段相连，所述输送鞘管通过所述鞘管接头与所述操作手柄相连。
  8. 根据权利要求7所述的输送器，其特征在于，所述鞘管接头包括连接部及与所述连接部相连的固定部，所述连接部套设于所述连接段上，且所述连接段的外径大于所述推送段的外径，所述固定部与所述操作手柄固定连接。
  9. 根据权利要求7所述的输送器，其特征在于，所述操作手柄包括固定手柄和活动手柄，所述鞘芯管和输送鞘管的近端均沿轴向穿入所述固定手柄和活动手柄中，且所述鞘芯管与所述固定手柄固定连接，所述输送鞘管通过所述鞘管接头与所述活动手柄固定连接。
  10. 一种管腔器械输送系统，其特征在于，包括管腔器械和如权利要求1～9任一项所述的输送器，所述管腔器械收容于所述收容腔中。
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