WO2020011132A1 - 管腔支架输送器 - Google Patents

管腔支架输送器 Download PDF

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Publication number
WO2020011132A1
WO2020011132A1 PCT/CN2019/095115 CN2019095115W WO2020011132A1 WO 2020011132 A1 WO2020011132 A1 WO 2020011132A1 CN 2019095115 W CN2019095115 W CN 2019095115W WO 2020011132 A1 WO2020011132 A1 WO 2020011132A1
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WO
WIPO (PCT)
Prior art keywords
conveyor
connecting portion
core tube
head
sheath core
Prior art date
Application number
PCT/CN2019/095115
Other languages
English (en)
French (fr)
Inventor
张军强
Original Assignee
先健科技(深圳)有限公司
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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
Publication of WO2020011132A1 publication Critical patent/WO2020011132A1/zh

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    • 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
    • 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Definitions

  • the invention relates to the field of medical equipment, and in particular to a lumen stent conveyor.
  • the human aorta is divided into ascending aorta, aortic arch, descending thoracic aorta, and abdominal aorta. Due to various pathological changes, such as inflammation and ulcers, it can cause damage to the aorta vascular intima or vessel wall. Under the combined action of blood flow impact, aneurysm disease is prone to occur. Once an aneurysm ruptures, a large amount of blood will flow out of the blood vessel, and the blood volume of the patient's blood circulation is insufficient, causing shock or death in the human body.
  • aneurysm disease For the treatment of aneurysm disease, it is commonly divided into surgical treatment and drug treatment. At present, the main treatment method is surgery. Traditional surgery is also surgery. After the extracorporeal blood circulation is established, the aneurysm diseased blood vessels are removed, and then artificial blood vessels are used to connect the blood vessels to achieve the normal circulation of arterial blood. As traditional aneurysm disease is treated with traditional surgery, it has a high risk of surgery and is relatively traumatic to humans. It takes a long time to recover after surgery. It will cause great physical trauma to the elderly and frail people.
  • Stent stent refers to artificial blood vessels that are compatible with the size of blood vessels. It is mainly composed of stent and supporting stent.
  • the stent is composed of polyester or e-PTFE membrane.
  • the support stent is mainly made of stainless steel wire or nickel-titanium alloy wire. The process of using a stent graft is to first compress the stent into the sheath of the stent delivery device.
  • the blood vessel is punctured at the femoral or iliac artery, and a guide wire is used to establish the track.
  • the stent is passed through the iliac artery-abdominal aorta-thoracic aorta.
  • Aortic arch the ascending aorta establishes a delivery path, and then delivers it to the designated location of the lesion, and then releases the stent.
  • the stent is deployed close to the wall of the aneurysm.
  • the stent cover isolates blood flow from the diseased site and eliminates blood flow to the diseased site aneurysm.
  • the impact of the wall establishes a channel for normal blood circulation, and then withdraws the guide wire and the conveyor to achieve interventional treatment of aneurysms and arterial dissections.
  • Covered stent interventional therapy has low cost, short treatment period, and small trauma to the human body, and has gradually become the mainstream for the treatment of aortic aneurysm diseases.
  • the requirements of stent graft intervention methods are mainly reflected in the following aspects: (1) whether the indicators of the stent graft meet the requirements; (2) whether the conveyor can normally load, transport and safely release the stent graft; (3) Whether the clinician can operate the conveyor normally and smoothly to ensure the normal operation of the surgery; (4) Whether the conveyor can be smoothly withdrawn from the body after the stent is released. It can be seen that the covered stent conveyor plays an important role in the interventional treatment of the covered stent.
  • the structure of the covered stent conveyor is mainly composed of the conveyor head, the sheath core tube, the push rod, the sheath tube, and the handle assembly.
  • the conveyor head and the sheath core tube are fixedly connected.
  • the fixed connection method between the conveyor head and the sheath core tube mainly adopts a welding fixation method, and the welding position is mainly at the contact position between the tail end of the conveyor head and the sheath core tube.
  • the welding will cause the surface of the sheath core tube Structural changes due to high temperature heating will cause stress concentration when the welding area is bent.
  • the welding position is likely to cause the conveyor to be stressed due to stress concentration.
  • the head and sheath core tube were broken, causing it to fall into the body, which caused the operation to fail.
  • a lumen stent delivery device includes a delivery head, a sheath core tube, and a connecting piece.
  • the connecting piece is at least partially accommodated in the delivery head, and the connecting piece includes a first connecting portion and a connection with the A second connection portion connected to a proximal end of the first connection portion, the first connection portion is fixedly connected to the sheath core tube, the second connection portion is fixedly connected to the conveyor head, and the second The axial length of the connecting portion is greater than the outer diameter of the sheath core tube.
  • first connection portion is sleeved on the sheath core tube, and an inner surface of the first connection portion is fixedly connected to an outer surface of the sheath core tube.
  • the second connecting portion is sleeved on the sheath core tube, and an outer surface of the second connecting portion is fixedly connected to an inner surface of the head of the conveyor.
  • an anchoring structure is formed on an outer surface of the second connection portion.
  • the anchoring structure is selected from at least one of a thread structure, a groove structure, and an open groove structure.
  • an outer surface of the second connection portion is a rough surface.
  • connection portion is connected to the conveyor head by glue or by injection molding.
  • first connection portion is located inside the conveyor head, and the second connection portion is at least partially located on the conveyor head.
  • the proximal end of the second connection portion protrudes from the conveyor head, and the proximal end of the second connection portion has a smooth s surface.
  • the connecting member further includes an abutting portion, the abutting portion is connected to a distal end of the first connecting portion, and a distal end of the sheath core tube abuts against the abutting portion.
  • the lumen stent conveyor is provided with a connecting member between the head of the transmitter and the sheath core tube, and the connecting member is provided with a first connecting portion and a second connecting portion.
  • the first connecting portion is fixedly connected to the sheath core tube, and the second connecting portion And the axial length of the second connecting part is larger than the outer diameter of the sheath core tube, so that when the lumen stent conveyor enters a complex tortuous vascular environment, the location of stress concentration can be in the tube of the connecting piece Inside the cavity, the bending force position can avoid the location of the stress concentration point, and can withstand large bending forces, so that no breakage occurs, and the head of the conveyor is prevented from falling off in the human blood vessel.
  • FIG. 1 is a schematic structural diagram of a lumen stent conveyor according to a first embodiment
  • FIG. 2 is a cross-sectional view of a connector, a conveyor head, and a sheath core tube according to a first embodiment
  • FIG. 3 is a cross-sectional view of the connecting member and the sheath core tube in FIG. 2;
  • FIG. 4 is a schematic structural diagram of a connecting member in which the anchoring structure of the second connecting portion in FIG. 3 is a groove;
  • FIG. 5 is a schematic structural diagram of a connecting member in which an anchoring structure of a second connecting portion according to a second embodiment is an open slot;
  • FIG. 6 is a cross-sectional view of a connecting member whose outer surface of the second connecting portion is a matte surface according to a third embodiment
  • FIG. 7 is a cross-sectional view of a threaded connecting member of an anchoring structure of a second connecting portion according to a fourth embodiment
  • FIG. 8 is a cross-sectional view of a connecting member and a sheath core tube according to a fifth embodiment
  • FIG. 9 is a schematic structural diagram of a connecting member whose anchoring structure of the second connecting portion is a groove according to a fifth embodiment
  • FIG. 10 is a cross-sectional view of a connector, a conveyor head, and a sheath core tube according to a sixth embodiment
  • FIG. 11 is a schematic structural diagram of a connecting member according to a sixth embodiment.
  • FIG. 12 is a schematic diagram of a lumen stent conveyor in a complex blood vessel model according to an embodiment of the present invention.
  • Lumen stent conveyor 100 Conveyor head 1 Sheath tube 2 Putter 3 Sheath tube 4 Proximal end face of conveyor head 13 Distal end face of putter 33 Distal end of sheath 44 Connector 5 First connection 52 Second connection 53 First through hole 522 Second through hole 532 Third through hole 55 Open slot 521,531,530 Groove 533 Raised 534, 5341 Abutment 54 Distal end of sheath tube twenty two Anchor part of the second connection part 57 Exposed part of the second connection part 58
  • proximal end refers to the end close to the operator during operation; the “distal end” refers to the end far from the operator during operation; “Axial” refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device.
  • a first embodiment provides a lumen stent conveyor 100, which includes a transporter head 1 and a sheath core tube 2, a push rod 3, and a sheath tube which are arranged inwardly from the outer sleeve in order. 4.
  • Sheath core tube 2, putter 3 and sheath tube 4 are coaxial.
  • the sheath-core tube 2 has a lumen structure, and the distal end of the sheath-core tube 2 is fixedly connected to the head 1 of the conveyor.
  • the putter 3 is a lumen structure, the putter 3 is sleeved on the proximal end of the sheath core tube 2, and the putter 3 and the sheath core tube 2 are kept relatively fixed.
  • there is a distance between the push rod 3 and the conveyor head 1 so that a part of the sheath core tube 2 is exposed outside the push rod 3 and the conveyor head 1. It can be understood that the exposed distance of this segment is the effective length after compression of the stent.
  • the sheath tube 4 has a lumen structure.
  • the sheath tube 4 is sleeved on the push rod 3, and the sheath tube 4 can slide axially relative to the push rod 3 and the sheath core tube 2.
  • the conveyor head 1 has a proximal end face 13 of the conveyor head, the sheath 4 has a distal end face 44 of the sheath, and the pusher 3 has a distal end face 33 of the pusher.
  • the distal end 44 of the sheath is near the conveyor head
  • an annular cavity is formed between the bare part of the sheath tube 4, the sheath core tube 2, the push rod 3 and the conveyor head 1, and the annular cavity is used to receive the compressed bracket ( Figure 1). Not shown).
  • FIG. 2 illustrates a connection manner of the conveyor head 1 and the sheath core tube 2 in the first embodiment.
  • the conveyor head 1 and the sheath core tube 2 are fixedly connected through a connecting member 5.
  • the connecting member 5 is completely accommodated in the conveyor head 1.
  • the sheath core tube 2 includes a distal end of the sheath core tube, and the distal end of the sheath core tube is fixedly connected with the connecting member 5.
  • Both the delivery head 1 and the sheath core tube 2 have a cavity structure and communicate with each other as a channel for the guide wire to ensure that the lumen stent conveyor 100 can smoothly enter the vascular lesion through the guide wire after passing through the guide wire. Pre-specified position.
  • the connecting member 5 includes a first connecting portion 52 and a second connecting portion 53 connected to a proximal end of the first connecting portion 52, wherein the first connecting portion 52 is fixedly connected to the sheath core tube 2 and the second connecting portion 53 is fixedly connected to the conveyor head 1.
  • the longitudinal center axes of the first connection portion 52 and the second connection portion 53 are collinear.
  • the sheath core tube 2 is sleeved in the connection 5, the sheath core tube 2 is coaxial with the connecting member 5.
  • the axial length of the first connecting portion 52 is L1 and the axial length of the second connecting portion 53 is L2.
  • the axial length L2 of the second connecting portion 53 is greater than the outer diameter of the sheath core tube 2.
  • the location of stress concentration can be inside the lumen of the connector 5, while the location of the bending force can avoid the location of the stress concentration point, and can withstand large bending forces, thereby No breakage will occur, thereby preventing the conveyor head 1 from falling out of the human blood vessel.
  • the first connecting portion 52 is a cylindrical structure. Please refer to 3 again, a first through hole 522 is defined in the middle of the first connecting portion 52.
  • the first connection portion 52 is sleeved on the sheath core tube 2, and the inner surface of the first connection portion 52 is fixedly connected to the outer surface of the sheath core tube 2.
  • the second connection portion 53 has a substantially cylindrical structure.
  • a second through hole 532 is defined in a middle portion of the second connecting portion 53.
  • the second through hole 532 is in communication with the first through hole 522, so that the sheath core tube 2 can be axially penetrated in the connecting member 5, that is, the connecting member 5 is sleeved on the sheath core tube 2.
  • the second connection portion 53 is sleeved on the sheath core tube 2, and the outer surface of the second connection portion 53 is fixedly connected to the inner surface of the conveyor head 1.
  • the first connection portion 52 and the second connection portion 53 may be integrally formed, or may be fixedly connected by welding or the like.
  • the manner in which the first connection portion 52 is fixedly connected to the sheath core tube 2 is selected from welding, glue connection, or injection molding fixed connection.
  • the welding is selected from metal laser welding, argon arc welding or ultrasonic welding.
  • the fixing manner between the first connecting portion 52 and the sheath core tube 2 may be several fixing points, or one or several fixing regions.
  • the connecting member 5 and the sheath core tube 2 are tightly fixedly connected; in other parts, such as the second connecting portion 53 It is not fixedly connected to the sheath core tube 2, and the second connection portion 53 is substantially the same as the inner diameter of the sheath core tube 2.
  • the position where the stress is concentrated is further inside the lumen of the connecting member 5, so that the bending stress position avoids the position of the stress concentration point, and a larger bending force is assumed, so as to avoid the occurrence between the sheath core tube 2 and the connecting member 5. fracture.
  • the manner in which the second connection portion 53 is fixedly connected to the conveyor head 1 is selected from glue connection or injection molding fixed connection.
  • the second connecting portion 53 has an anchoring structure 57, and glue or injection molding material is injected into the anchoring structure 57, so that the second connecting portion 53 is fixedly connected to the conveyor head 1 through the anchoring structure 57.
  • the anchoring structure 57 is selected from at least one of a threaded structure, a groove structure, and an open groove structure.
  • the anchoring structure 57 is located on the outer surface of the second connecting portion 53 and is in direct contact with the inner area of the conveyor head 1, which can increase the connection force between the conveyor head 1 and the connecting member 5.
  • the outer surface of the second connection portion 53 is a rough surface.
  • the outer surface of the second connection portion 53 is a matte surface, and the matte surface is coated with glue or injection molding material so that the matte surface is in direct contact with the inner area of the conveyor head 1, and the conveyor head 1 may also be added.
  • the connecting force with the connecting member 5 is a matte surface, and the matte surface is coated with glue or injection molding material so that the matte surface is in direct contact with the inner area of the conveyor head 1, and the conveyor head 1 may also be added.
  • the anchoring structure 57 of the second connection portion 53 in FIG. 3 is a groove structure, and the groove structure is filled with glue or injection-molded material, so that the second connection portion 53 and the conveyor head 1 are fixed by glue or injection-molding. connection.
  • a plurality of grooves 533 may be formed on an outer wall of the second connection portion 53 to form a trench structure.
  • a plurality of protrusions 534 may be provided on an outer wall of the second connection portion 53, and a groove 533 is formed between two adjacent protrusions 534 to form a trench structure.
  • the groove structure is uniformly distributed along the circumferential direction of the second connection portion 53, which is beneficial to increase the contact portion of the second connection portion 53 with the glue connection or injection molding connection of the conveyor head 1 and improve the reliability of the connection.
  • the protrusion 534 includes a protrusion 5341 which is ring-shaped and is provided at a connection point with the first connecting portion 52.
  • the protrusion 5341 may also be a plurality of small protrusions. It is the same as or different from the other protrusions 534.
  • the distribution of the groove structure is not limited to a uniform distribution, and any distribution that can satisfy the reliable connection of the second connection portion 53 and the conveyor head 1 may be used.
  • the connecting member 5 includes a first connecting portion 52 and a second connecting portion 53 connected to the proximal end of the first connecting portion 52.
  • the axial length of the first connecting portion 52 is L1 and the axial length of the second connecting portion 53 is L2.
  • the first connecting portion 52 and the second connecting portion 53 are both hollow cylindrical structures, and the connecting member 5 is a hollow cylindrical structure integrally formed by the first connecting portion 52 and the second connecting portion 53.
  • the anchoring structure of the second connection portion 53 is two opening grooves 530 and 531 opened at the proximal end of the second connection portion 53.
  • the opening groove 530 and the opening groove 532 are arranged symmetrically with respect to the longitudinal center axis of the connecting member 5.
  • the opening groove 530 and the opening groove 532 are both U-shaped grooves, and the opening direction of the U-shaped grooves is toward the proximal end in the axial direction.
  • the number of the open slot structure is not limited to two, and may be multiple.
  • the shape of the open slot structure is not limited to a “U” shape, and may be a circle, a square, a diamond, or an irregular shape. An injection-molded material or glue is added into the open slot structure, so that the connecting member 5 is fixedly connected to the conveyor head 1.
  • the first connecting portion 52 is further provided with an open groove structure. As shown in FIG. 5, two opening grooves 521 are also formed on the distal end of the first connecting portion 52.
  • the two opening grooves 521 are U-shaped grooves, and the two opening grooves 521 are symmetrically arranged along the longitudinal center axis of the connecting member 5.
  • the opening direction of the U-shaped groove is toward the distal end in the axial direction, and the first connection
  • the two opening grooves 521 on the portion 52 and the two opening grooves 530 and 532 of the second connecting portion 53 are respectively disposed symmetrically with respect to the lateral center axis of the connecting member 5.
  • the number of the opening grooves on the first connecting portion 52 is not limited to two, and may be multiple.
  • the shape of the opening groove structure is not limited to a “U” shape, and may be circular, square, diamond, or not. In a regular shape, the position of the opening groove may not be symmetrical to the opening groove of the second connecting portion 53 with the lateral central axis of the connecting member 5.
  • the connecting member 5 is a hollow cylindrical structure formed integrally by the first connecting portion 52 and the second connecting portion 53.
  • the outer surface of the second connection portion 53 is a matte rough surface structure.
  • the injection-molded material or glue covers the matte rough surface structure, and then directly contacts and is fixedly connected with the conveyor head 1.
  • the matte rough surface structure has better anti-skid performance, which is beneficial to make the conveyor head 1 and the second connection portion 53 more reliably connected.
  • the connecting member 5 is a hollow cylindrical structure integrally formed by the first connecting portion 52 and the second connecting portion 53.
  • An anchoring structure is formed on the outer surface of the second connection portion 53.
  • the anchoring structure is a threaded structure.
  • the injection-molded material or glue covers the threaded structure, and then comes into direct contact with the conveyor head 1 and is fixedly connected.
  • the screw structure has better anti-slip performance, which is beneficial to make the conveyor head 1 and the second connection portion 53 more reliably connected.
  • connection 5 of the fifth embodiment is shown in FIGS. 8 and 9.
  • the structure of the connector 5 of this embodiment is substantially the same as that of the connector 5 of the first embodiment.
  • the connection 5 in this embodiment further includes an abutting portion 54.
  • the abutting portion 54 is axially connected to the distal end of the first connecting portion 52.
  • a third through hole 55 is defined in a middle portion of the abutting portion 54.
  • the third through hole 55 communicates with the first through hole 522 (see FIG. 3) of the first connection portion 52 and the second through hole 532 of the second connection portion 53.
  • the diameter of the third through hole 55 is smaller than the diameter of the first through hole 522 and the diameter of the second through hole 532, and the diameter of the third through hole 55 is smaller than the outer diameter of the sheath core tube 2.
  • the sheath core tube 2 also includes a distal end surface 22 of the sheath core tube, and the distal end of the sheath core tube is inserted into the connecting member 5 so that the distal end surface 22 of the sheath core tube is in contact with the abutment portion 54 so that the sheath core tube 2 cannot be connected through Piece 5, but the guide wire can be allowed to pass through the connecting piece 5, and finally the guide wire is passed through the cavity of the head 1 of the conveyor. It can be understood that, in this fifth embodiment, other parts are the same as the first connection mode.
  • a sixth embodiment of the present invention is shown. Compared with the fifth embodiment, the difference lies in the connection manner between the connecting member 5 and the conveyor head 1.
  • the connector 5 is partially accommodated in the conveyor head 1, wherein the first connection portion 52 is located inside the conveyor head 1, and the second connection portion 53 is located in the conveyor head 1, wherein the second connection The portion 53 includes an anchor portion 57 and a bare portion 58.
  • a portion of the connector 5 inside the conveyor head 1 (including the anchoring portion 57 of the first connecting portion 52 and the second connecting portion 53) and a portion exposed outside the conveyor head 1 (including The exposed portions 58) of the second connecting portion 53 may be the same material or different materials.
  • the structure of the exposed portion 58 of the second connection portion 53 is different from the anchor portion 57 of the second connection portion 53.
  • the exposed portion 58 of the second connection portion 53 has a smooth surface.
  • the smooth surface includes a smooth outer peripheral surface and a smooth proximal end surface.
  • the anchoring structure 57 of the second connecting portion 53 of the connecting member 5 is a groove structure, and the groove structure is located in the conveyor head 1.
  • the groove structure here is slightly different from the groove structure in the fifth embodiment (see FIG. 9).
  • the groove structure here is formed by forming an annular groove 533 between two annular protrusions 534.
  • the groove structure in the first embodiment is composed of a plurality of small protrusions distributed in a ring shape to form a mesh groove. It can be understood that the trench structures mentioned in the first embodiment and the second embodiment may be the same or different.
  • the trench structure can also be irregularly distributed with a number of small protrusions, or a number of protrusions with different sizes and shapes.
  • the anchoring structure 57 of the second connecting portion 53 of the connecting member 5 may be further selected from at least one of a screw structure, a groove structure, and an open groove structure.
  • the outer surface of the second connection portion 53 is a rough surface.
  • the outer surface of the second connection portion 53 is a matte surface, and the matte surface is coated with glue or injection molding material so that the matte surface is in direct contact with the inner area of the conveyor head 1, and the conveyor head 1 may be added The connecting force with the connecting member 5.
  • the other components and the connection methods of the components are the same as those of the first embodiment, and will not be repeated here.
  • the part of the connecting member 5 accommodated in the conveyor head cannot protrude from the outer edge surface of the conveyor head 1, so as to be exposed on the outer edge surface of the conveyor head 1, so as to avoid nakedness. Scraping blood vessels during the clinical process.
  • the lumen stent conveyor 100 described above is provided with a connector 5 between the transmitter head 1 and the sheath core tube 2, and the connector 5 is provided with a first connection portion 52 and a second connection portion 53.
  • the first connection portion 52 and the sheath The core tube 2 is fixedly connected, the second connection portion 53 is fixedly connected to the conveyor head 1, and the axial length of the second connection portion 53 is greater than the outer diameter of the sheath core tube 2, so that the lumen stent conveyor 100 enters a complex tortuous In a blood vessel 200 environment, as shown in FIG. 12, the location of stress concentration can be inside the lumen of the connector 5, and the location of the bending force can avoid the location of the stress concentration point, and it can withstand large bending forces, which will not occur. Rupture, thereby preventing the conveyor head 1 from falling out of the human blood vessel 200.

Abstract

本发明涉及一种管腔支架输送器，包括输送器头部、鞘芯管和连接件，连接件至少部分容纳于输送器头部中，连接件包括第一连接部和与第一连接部的近端相连的第二连接部，第一连接部与鞘芯管固定连接，第二连接部与输送器头部固定连接，且第二连接部的轴向长度大于鞘芯管的外径，从而确保鞘芯管与输送器头部连接安全、可靠，进而保证临床操作能够正常进行。

Description

管腔支架输送器 技术领域
本发明涉及医疗器械领域，特别是涉及一种管腔支架输送器。
背景技术
人体的主动脉分为升主动脉、主动脉弓、胸降主动脉和腹主动脉。由于各种病理改变，如炎症、溃疡等会造成主动脉血管内膜或血管壁的损伤，在血流冲击力的共同作用下，容易发生动脉瘤疾病。动脉瘤一旦破裂，大量血液将会流出血管，病人血液循环的血量不足，造成人体休克或死亡。
对于动脉瘤疾病的治疗方法，常见的分为手术治疗和药物治疗。目前治疗方式以手术治疗为主，传统手术治疗也就是开刀手术，在建立体外血液循环后，将动脉瘤病变血管进行切除，再利用人造血管连接血管，实现动脉血液的正常循环。由于采用传统手术治疗动脉瘤疾病的方式手术风险高、对人创伤较大，术后需要较长的时间恢复，对老年、体弱人群，将会造成很大身体创伤。
近年来，利用介入治疗方式治疗心血管疾病成为一种新的治疗方法。随着介入技术的不断发展，采用覆膜支架治疗主动脉瘤和动脉夹层疾病的优势日显突出，覆膜支架是指与血管大小相适应的人工血管，它主要由覆膜和支撑覆膜的支架组成，覆膜一般是由涤纶或e-PTFE膜制成，支撑支架主要由不锈钢丝或镍钛合金丝编织而成。覆膜支架使用过程是先将支架压缩进支架输送器的鞘管内，一般选择在股动脉或髂动脉位置穿刺血管，利用导丝建立轨道，将输送器经髂动脉—腹主动脉—胸主动脉—主动脉弓—升主动脉建立输送路径，进而输送到病变指定位置，然后释放支架，支架展开紧贴动脉瘤管壁，支架的覆膜将血流和病变部位隔绝，消除血流对病变部位动脉瘤壁的冲击，建立血液正常循环的通道，然后撤出导丝和输送器，实现对动脉瘤和动脉夹层的介入治疗。
采用覆膜支架介入治疗方法成本低、治疗周期短、对人体创伤小，逐渐成为治疗主动脉瘤疾病的主流。然而覆膜支架介入方法对支架的要求主要体现在以下方面：(1)覆膜支架的各项指标是否达到要求；(2)输送器能否能将覆膜 支架正常装载、输送和安全释放；(3)临床医生能否正常顺利对输送器进行操作，保证手术正常进行；(4)输送器在支架释放完成后能否顺利撤出体外。由此可见覆膜支架的输送器在覆膜支架介入治疗过程中起着重要作用。
覆膜支架输送器的构成主要由输送器头部、鞘芯管、推杆、鞘管、手柄组件几部分组成，输送器头部和鞘芯管之间为固定连接。目前，输送器头部和鞘芯管之间固定连接方式主要采用焊接的固定方式，并且焊接位置主要在输送器头部的尾端与鞘芯管的接触位置，由于焊接会使鞘芯管表面因高温受热发生结构变化，进而使焊接区域在弯曲的情况下会产生应力集中，在装载有支架的输送器沿着导丝进入复杂的血管模型时，焊接位置容易因产生应力集中而使输送器头与鞘芯管发生折断，使造成其掉进体内，进而造成手术失败。
发明内容
基于此，有必要提供一种具有可靠的鞘芯管与输送器头部固定连接方式的管腔支架输送器，确保鞘芯管与输送器头部连接安全、可靠，进而保证临床操作能够正常进行。
一种管腔支架输送器，包括输送器头部、鞘芯管和连接件，所述连接件至少部分容纳于所述输送器头部中，所述连接件包括第一连接部和与所述第一连接部的近端相连的第二连接部，所述第一连接部与所述鞘芯管固定连接，所述第二连接部与所述输送器头部固定连接，且所述第二连接部的轴向长度大于所述鞘芯管的外径。
进一步地，所述第一连接部套设于所述鞘芯管上，且所述第一连接部的内表面与所述鞘芯管的外表面固定连接。
进一步地，所述第二连接部套设于所述鞘芯管上，且所述第二连接部的外表面与所述输送器头部的内表面固定连接。
进一步地，所述第二连接部的外表面形成有锚定结构。
进一步地，所述锚定结构选自螺纹结构、沟槽结构及开口槽结构中的至少一种。
进一步地，所述第二连接部的外表面为粗糙面。
进一步地，所述第二连接部与所述输送器头部通过胶水连接或通过注塑连接。
进一步地，所述第一连接部位于所述输送器头部的内部，所述第二连接部至少部分位于所述输送器头部。
进一步地，当所述第二连接部部分位于所述输送器头部时，所述第二连接部的近端伸出所述输送器头部，且所述第二连接部的近端具有光滑的表面。
进一步地，所述连接件还包括抵接部，所述抵接部与所述第一连接部的远端连接，所述鞘芯管的远端与所述抵接部抵接。
上述管腔支架输送器通过在输送器头部和鞘芯管之间设置连接件，在连接件设置第一连接部和第二连接部，第一连接部与鞘芯管固定连接，第二连接部与输送器头部固定连接，且第二连接部的轴向长度大于鞘芯管的外径，使管腔支架输送器进入复杂曲折的血管环境时，应力集中的位置能处于连接件的管腔内部，而弯曲受力位置能够避开应力集中点位置，可以承受较大的弯曲力，进而不会产生断裂，进而避免输送器头部脱落在人体血管中。
附图说明
图1为第一实施方式提供的管腔支架输送器的结构示意图；
图2为第一实施方式提供的连接件与输送器头部和鞘芯管的剖视图；
图3为图2中连接件与鞘芯管的剖视图；
图4为图3中第二连接部的锚定结构为沟槽的连接件的结构示意图；
图5为第二实施方式提供的第二连接部的锚定结构为开口槽的连接件的结构示意图；
图6为第三实施方式提供的第二连接部的外表面为磨砂面的连接件的剖视图；
图7为第四实施方式提供的第二连接部的锚定结构为螺纹的连接件的剖视图；
图8为第五实施方式提供的连接件与鞘芯管的剖视图；
图9为第五实施方式提供的第二连接部的锚定结构为沟槽的连接件的结构 示意图；
图10为第六实施方式提供的连接件与输送器头部和鞘芯管的剖视图；
图11为第六实施方式提供的连接件的结构示意图；
图12为本发明实施例提供的管腔支架输送器在复杂血管模型中的示意图。
主要元件符号说明
管腔支架输送器 100
输送器头部 1
鞘芯管 2
推杆 3
鞘管 4
输送器头部近端端面 13
推杆远端端面 33
鞘管远端端面 44
连接件 5
第一连接部 52
第二连接部 53
第一通孔 522
第二通孔 532
第三通孔 55
开口槽 521，531，530
凹槽 533
凸起 534、5341
抵接部 54
鞘芯管远端端面 22
第二连接部的锚定部分 57
第二连接部的裸露部分 58
血管 200
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明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发明。但是本发明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发明内涵的情况下做类似改进，因此本发明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发明的技术领域的技术人员通常理解的含义相同。本文中在本发明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，不是旨在于限制本发明。
首先，需要在此强调的是本发明实施方式中提到的“近端”是指在操作过程中，靠近操作者的一端；“远端”是指在操作过程中，远离操作者的一端；“轴向”指平行于医疗器械远端中心和近端中心连线的方向。
参照图1，第一实施方式提供了一种管腔支架输送器100，该管腔支架输送器100包括输送器头部1和依次由内向外套设的鞘芯管2、推杆3和鞘管4，鞘芯管2、推杆3和鞘管4同轴。
其中，鞘芯管2为管腔结构，鞘芯管2的远端与输送器头部1固定连接。推杆3为管腔结构，推杆3套设于鞘芯管2的近端，推杆3与鞘芯管2保持相对固定。并且，推杆3和输送器头部1之间具有一段距离，使鞘芯管2的一部分裸露于推杆3和输送器头部1之外。可以理解的，该段裸露的距离为支架压缩后的有效长度。
鞘管4为管腔结构。鞘管4套设于推杆3上，鞘管4相对于推杆3和鞘芯管2可轴向滑动。
输送器头部1具有输送器头部近端端面13，鞘管4具有鞘管远端端面44，推杆3具有推杆远端端面33，当鞘管远端端面44与输送器头部近端端面13合拢时，鞘管4、鞘芯管2的裸露部分、推杆3和输送器头部1四者之间形成一个环形腔体，环形腔体用于容纳压缩后的支架(图1未示)。当鞘管4进行轴向滑 动并且后撤到鞘管远端端面44与推杆远端端面33保持平齐或者推杆3部分裸露在鞘管4外面时，环形腔体消失，支架释放打开。
请参照图2，图2示出了第一实施方式中输送器头部1与鞘芯管2的连接方式。输送器头部1与鞘芯管2通过连接件5固定连接。本实施方式中，连接件5完全容纳于输送器头部1中。鞘芯管2包括鞘芯管远端，鞘芯管远端与连接件5固定连接。输送器头部1和鞘芯管2均呈腔体结构，并且相互连通，以作为导丝的通道，保证管腔支架输送器100穿过导丝后通过导丝的引导可以顺利地进入血管病变预指定位置。
请参阅图2，连接件5包括第一连接部52和与第一连接部52的近端相连的第二连接部53，其中第一连接部52与鞘芯管2固定连接，第二连接部53与输送器头部1固定连接。第一连接部52和第二连接部53的纵向中心轴线共线。鞘芯管2套设于连接5中时，鞘芯管2与连接件5同轴。请参阅图3，第一连接部52的轴向长度为L1，第二连接部53的轴向长度为L2，其中第二连接部53的轴向长度L2大于鞘芯管2的外径，使管腔支架输送器100进入复杂曲折的血管环境时，应力集中的位置能处于连接件5的管腔内部，而弯曲受力位置能够避开应力集中点位置，可以承受较大的弯曲力，进而不会产生断裂，进而避免输送器头部1脱落在人体血管中。
具体地，请参阅图4，本实施方式中，第一连接部52为圆柱体结构。请再次参阅3，第一连接部52的中部开设有第一通孔522。第一连接部52套设于鞘芯管2上，且第一连接部52的内表面与鞘芯管2的外表面固定连接。
第二连接部53大致为圆柱体结构。第二连接部53的中部开设有第二通孔532。第二通孔532与第一通孔522连通，使得鞘芯管2能够轴向穿设于连接件5中，即连接件5套设于鞘芯管2上。第二连接部53套设于鞘芯管2上，且第二连接部53的外表面与输送器头部1的内表面固定连接。
第一连接部52和第二连接部53可以一体成型，也可以通过焊接等方式固定连接。
第一连接部52与鞘芯管2固定连接的方式选自焊接、胶水连接或注塑固定连接。其中焊接选自金属激光焊接、氩弧焊接或超声波焊接。在本实施例中， 第一连接部52与鞘芯管2之间固定的方式可以为若干个固定点，或者一个或几个固定区域。
值得说明的是，连接件5与鞘芯管2之间，在第一连接部52的固定点处，连接件5与鞘芯管2为紧密固定连接；在其他部位，如第二连接部53与鞘芯管2之间并非固定连接，第二连接部53与鞘芯管2内径尺寸大致相同。如此设计，进一步地使应力集中的位置处于连接件5的管腔内部，使弯曲受力位置避免应力集中点位置，承担较大的弯曲力，从而避免鞘芯管2与连接件5之间产生断裂。
第二连接部53与输送器头部1固定连接的方式选自胶水连接或注塑固定连接。第二连接部53具有锚定结构57，并在锚定结构57内注入胶水或注塑材料，使第二连接部53通过锚定结构57与输送器头部1固定连接。在一实施方式中，该锚定结构57选自螺纹结构、沟槽结构及开口槽结构中的至少一种。锚定结构57位于第二连接部53的外表面，与输送器头部1的内部区域直接接触，可以增加输送器头部1与连接件5的连接力。或者，第二连接部53的外表面为粗糙面。例如，第二连接部53的外表面为磨砂面，在该磨砂面上涂上胶水或注塑材料，使该磨砂面与输送器头部1的内部区域直接接触，也可以增加输送器头部1与连接件5的连接力。
具体地，图3中第二连接部53的锚定结构57为沟槽结构，该沟槽结构内充满胶水或注塑的材料，使得第二连接部53与输送器头部1通过胶水或注塑固定连接。
具体地，如图4所示，在一实施方式中，可以在第二连接部53的外壁上开设多个凹槽533以形成沟槽结构。或者，在另外的实施方式中，也可以在第二连接部53的外壁上设置多个凸起534，相邻的两个凸起534之间形成凹槽533，从而形成沟槽结构。本实施方式中，沟槽结构沿第二连接部53的周向均匀分布，有利于增加第二连接部53与输送器头部1的胶水连接或注塑连接的接触部位，提高连接的可靠性。在图4中，该凸起534包括凸起5341，该凸起5341呈环状，设置在与第一连接部52连接处，在其他实施方式中，该凸起5341也可为多个小凸起，与其它的凸起534相同或不同。
可以理解，在其他实施方式中，沟槽结构的分布不限于均匀分布，任何能够满足第二连接部53与输送器头部1可靠连接的沟槽结构的分布均可。
第二实施方式的连接件5的结构如图5所示。连接件5包括第一连接部52和与第一连接部52的近端相连的第二连接部53，其中第一连接部52的轴向长度为L1，第二连接部53的轴向长度为L2。第一连接部52和第二连接部53均为中空的圆柱体结构，连接件5为由第一连接部52和第二连接部53一体式形成的中空的圆柱体结构。在本实施方式中，第二连接部53的锚定结构为在第二连接部53的近端开设的两个开口槽530、531。开口槽530和开口槽532以连接件5的纵向中心轴线对称设置。本实施方式中，开口槽530和开口槽532均为U形槽，U形槽的开口方向沿轴向方向朝向近端。在其他实施方式中，该开口槽结构的数量不限于两个，可以为多个，该开口槽结构的形状不限于“U”形，可以为圆形、方形、菱形或不规则形状。在开口槽结构内加入注塑的材料或胶水，使连接件5与输送器头部1固定连接。
进一步地，第一连接部52上还设有开口槽结构。如图5所示，在第一连接部52的远端上也开设有两个开口槽521。本实施方式中，两个开口槽521均为U形槽，该两个开口槽521以连接件5的纵向中心轴线对称设置，U形槽的开口方向沿轴向方向朝向远端，第一连接部52上的两个开口槽521与第二连接部53的两个开口槽530、532分别以连接件5的横向中心轴线对称设置。在其他实施方式中，第一连接部52上的开口槽的数量不限于两个，可以为多个，该开口槽结构的形状不限于“U”形，可以为圆形、方形、菱形或不规则形状，该开口槽的位置可不与第二连接部53的开口槽以连接件5的横向中心轴线对称设置。
第三实施方式的连接件5的结构如图6所示。本实施方式中，连接件5为由第一连接部52和第二连接部53一体式形成的中空圆柱体结构。第二连接部53的外表面为磨砂粗糙面结构。注塑的材料或胶水覆盖在磨砂粗糙面结构上，然后与输送器头部1直接接触并固定连接。磨砂粗糙面结构具有较好的防滑性能，有利于使输送器头部1与第二连接部53更可靠地连接。
第四实施方式的连接件5的结构如图7所示。本实施方式，连接件5为由第一连接部52和第二连接部53一体式形成的中空圆柱体结构。第二连接部53 的外表面形成有锚定结构。锚定结构为螺纹结构。注塑的材料或胶水覆盖在螺纹结构上，然后与输送器头部1直接接触并固定连接。螺纹结构具有较好的防滑性能，有利于使输送器头部1与第二连接部53更可靠地连接。
第五实施方式的连接件5的结构如图8和图9所示。本实施方式的连接件5与第一实施方式的连接件5的结构大致相同。不同的是，本实施方式的连接5还包括抵接部54。抵接部54与第一连接部52的远端轴向连接。抵接部54的中部开设有第三通孔55。第三通孔55与第一连接部52的第一通孔522(参看图3)和第二连接部53的第二通孔532连通。并且，第三通孔55的孔径均小于第一通孔522的孔径和第二通孔532的孔径，第三通孔55的孔径小于鞘芯管2的外径。鞘芯管2还包括鞘芯管远端端面22，鞘芯管远端插入连接件5中，使鞘芯管远端端面22与抵接部54抵接，从而使鞘芯管2不能贯穿连接件5，但是可以允许导丝穿过连接件5，最终使导丝贯穿输送器头部1的腔体。可以理解的，在该第五实施方式中，其他部分均与第一连接方式相同。
请参照图10和图11，展示了本发明的第六实施方式，与第五实施方式相比，区别在于连接件5与输送器头部1的连接方式。在本实施方式中，连接件5部分容纳于输送器头部1，其中第一连接部52位于输送器头部1的内部，第二连接部53部分位于输送器头部1，其中第二连接部53包括锚定部分57和裸露部分58。在本实施方式中，连接件5位于输送器头部1内的部分(包括第一连接部52和第二连接部53的锚定部分57)和裸露在输送器头部1外的部分(包括第二连接部53的裸露部分58)可以为同种材质，也可以为不同种材质。该第二连接部53的裸露部分58的结构不同于第二连接部53的锚定部分57，该第二连接部53的裸露部分58具有光滑的表面。该光滑的表面包括光滑的外周面和光滑的近端端面。
结合图10和图11，连接件5的第二连接部53的锚定结构57为沟槽结构，该沟槽结构位于输送器头部1内。此处的沟槽结构与第五实施方式中的沟槽结构(参看图9)略有不同，此处的沟槽结构是由两个环形凸起534之间形成环形的凹槽533而组成，而第一实施方式中的沟槽结构为若干个小凸起呈环状分布形成网状凹槽而组成。可以理解的，第一实施方式和第二实施方式中提到的沟 槽结构，可以相同，也可以不相同。该沟槽结构还可以为若干小凸起不规则分布，或者为若干个尺寸和形状不相同的凸起。在本实施方式中，连接件5的第二连接部53的锚定结构57还可以选自螺纹结构、沟槽结构及开口槽结构中的至少一种。或者，第二连接部53的外表面为粗糙面。例如，第二连接部53的外表面为磨砂面，在该磨砂面上涂上胶水或注塑材料，使该磨砂面与输送器头部1的内部区域直接接触，也可以增加输送器头部1与连接件5的连接力。其他元件及元件的连接方式均与第一实施方式相同，在此不再赘述。
在本发明的实施方式中，连接件5容纳到输送器头部的部分不能凸出于输送器头部1的外缘表面，从而裸露在输送器头部1的外缘表面，避免出现裸露而在临床过程中刮伤血管。
上述管腔支架输送器100通过在输送器头部1和鞘芯管2之间设置连接件5，在连接件5设置第一连接部52和第二连接部53，第一连接部52与鞘芯管2固定连接，第二连接部53与输送器头部1固定连接，且第二连接部53的轴向长度大于鞘芯管2的外径，使管腔支架输送器100进入复杂曲折的血管200环境时，如图12所示，应力集中的位置能处于连接件5的管腔内部，而弯曲受力位置能够避开应力集中点位置，可以承受较大的弯曲力，进而不会产生断裂，进而避免输送器头部1脱落在人体血管200中。
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发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种管腔支架输送器，包括输送器头部、鞘芯管和连接件，所述连接件至少部分容纳于所述输送器头部中，其特征在于，
    所述连接件包括第一连接部和与所述第一连接部的近端相连的第二连接部，所述第一连接部与所述鞘芯管固定连接，所述第二连接部与所述输送器头部固定连接，且所述第二连接部的轴向长度大于所述鞘芯管的外径。
  2. 如权利要求1所述的管腔支架输送器，其特征在于，所述第一连接部套设于所述鞘芯管上，且所述第一连接部的内表面与所述鞘芯管的外表面固定连接。
  3. 如权利要求1所述的管腔支架输送器，其特征在于，所述第二连接部套设于所述鞘芯管上，且所述第二连接部的外表面与所述输送器头部的内表面固定连接。
  4. 如权利要求1～3任一项所述的管腔支架输送器，其特征在于，所述第二连接部的外表面形成有锚定结构。
  5. 如权利要求4所述的管腔支架输送器，其特征在于，所述锚定结构选自螺纹结构、沟槽结构及开口槽结构中的至少一种。
  6. 如权利要求3所述的管腔支架输送器，其特征在于，所述第二连接部的外表面为粗糙面。
  7. 如权利要求3所述的管腔支架输送器，其特征在于，所述第二连接部与所述输送器头部通过胶水连接或通过注塑连接。
  8. 如权利要求1所述的管腔支架输送器，其特征在于，所述第一连接部位于所述输送器头部的内部，所述第二连接部至少部分位于所述输送器头部。
  9. 如权利要求8所述的管腔支架输送器，其特征在于，当所述第二连接部部分位于所述输送器头部时，所述第二连接部的近端伸出所述输送器头部，且所述第二连接部的近端具有光滑的表面。
  10. 如权利要求1所述的管腔支架输送器，其特征在于，所述连接件还包括抵接部，所述抵接部与所述第一连接部的远端连接，所述鞘芯管的远端与所述抵接部抵接。
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