CN116212201A - Low-resistance conveying assembly and bracket conveying system - Google Patents

Low-resistance conveying assembly and bracket conveying system Download PDF

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Publication number
CN116212201A
CN116212201A CN202310135815.XA CN202310135815A CN116212201A CN 116212201 A CN116212201 A CN 116212201A CN 202310135815 A CN202310135815 A CN 202310135815A CN 116212201 A CN116212201 A CN 116212201A
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CN
China
Prior art keywords
hypotube
wire
distal end
developing
wire harness
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Granted
Application number
CN202310135815.XA
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Chinese (zh)
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CN116212201B (en
Inventor
崔亚飞
叶嘉铭
王格
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Shanghai Li Kai Technology Co ltd
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Shanghai Li Kai Technology Co ltd
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Priority to CN202310135815.XA priority Critical patent/CN116212201B/en
Publication of CN116212201A publication Critical patent/CN116212201A/en
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Publication of CN116212201B publication Critical patent/CN116212201B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M25/09041Mechanisms for insertion of guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505Instruments 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
    • A61F2002/9511Instruments 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 the retaining means being filaments or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • A61F2002/9665Instruments 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 with additional retaining means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip
    • A61M2025/09183Guide wires having specific characteristics at the distal tip having tools at the distal tip

Abstract

The application relates to a low-resistance conveying assembly, which comprises a conveying core wire, a hypotube, a binding tube and a wire harness; the conveying core wire is fixedly arranged in the hypotube in a penetrating way; the outer wall of the proximal end side of the hypotube is sleeved with a binding tube, and the outer wall of the distal end side of the hypotube is suitable for being attached to a vascular stent; the wire harness is arranged on the hypotube and the binding tube in a penetrating mode, and the wire harness can bind the vascular stent. Through wearing to establish in the hypotube and carry the core silk, and establish the binding tube at the proximal end side outer wall cover of hypotube, and wear to establish the pencil and connect hypotube and binding tube, as low resistance conveying component, establish the vascular support cover on the hypotube, the pencil is bound, the constraint to it from the outside of hypotube is spiral, be used for restricting the radial holding power of vascular support in compression state when carrying, thereby reduce vascular support and hold the extrusion force of state to sheath pipe or microcatheter under pressing, and then effectively reduce the resistance in the transportation.

Description

Low-resistance conveying assembly and bracket conveying system
Technical Field
The application relates to the technical field of medical equipment, in particular to a low-resistance conveying assembly and a bracket conveying system.
Background
Vascular aneurysms (aneurosm) are manifestations of limitation or diffuse expansion or distension of the arterial wall due to lesions or lesions of the arterial wall, with distending, pulsating masses being the main manifestation. Aneurysms can occur anywhere in the arterial system, including abdominal aortic aneurysms, cerebral aneurysms, peripheral aneurysms, visceral aneurysms, and the like. Aneurysms are thin and fragile in wall and are therefore prone to rupture. In interventional therapy, one method commonly used is to implant embolic materials such as releasable balloons and coils into the tumor body of an aneurysm through a catheter, so that the blood flow velocity in the tumor body is obviously slowed down or stagnated, and thrombus is gradually formed so as to block the tumor body, thereby achieving the purpose of preventing the rupture of the aneurysm. Large or giant aneurysms are often wide-necked aneurysms, and the stuffed coils are very prone to protruding into the aneurysm-carrying artery, causing stenosis or even occlusion of the carrying artery. Taking the case of cerebral aneurysms, this can lead to serious consequences such as cerebral ischemia and even cerebral infarction. Second, large or giant aneurysms often have a placeholder effect, with the enlarged body compressing the surrounding vital organs and tissues, affecting their physiological function, and the coil-filled aneurysms, while being capable of occluding the aneurysm, do not address the placeholder effect of the body, and even make the placeholder effect more severe.
A dense-mesh stent-based blood flow guiding device has been developed in recent years that effectively overcomes the above-described drawbacks of the packing-coil therapies in the treatment of large or giant aneurysms. After being implanted into the parent artery, on one hand, the blood flow guiding device can interfere the blood flow entering the aneurysm body from the parent artery by virtue of fine meshes, so that the blood in the aneurysm body is accumulated to form thrombus, and the aneurysm is completely occluded; on the other hand, the blood vessel endothelial cells can climb, and after the blood flow guiding device is covered by the endothelial cells, a permanent biological seal is formed on the neck of the aneurysm, so that the aneurysm-carrying artery is restored to a normal blood vessel.
However, the dense mesh stent-based blood flow guides and coil assist stents described above currently have some disadvantages. In addition to the performance of the stent itself, the design of the delivery system affects the resistance in the delivery process and the experience of the operator, taking the Tubridge blood flow guiding device of the minimally invasive Shentong company as an example, since the stent is pressed and held on the silicone tube on the core, the delivery principle is that the stent is extruded from the inner side of the stent by the deformation of the silicone tube to generate extrusion force, and the silicone tube and the stent wire are embedded and rubbed, so that the stent is driven by the delivery core wire to be delivered to the distal end in the microcatheter through the silicone tube in the distal delivery process. In this process, the stent is pressed outward from the inner wall, and the radial supporting force under the stent restraint becomes large due to the inner side pressing of the silicone tube because the stent is pressed and held in the sheath tube or the microcatheter.
In summary, in the process of conveying the stent to the distal end in the sheath tube or the microcatheter, as the silicone tube extrudes the vascular stent from the inside of the stent to the outer periphery, the radial supporting force of the stent to the outer periphery is increased, so that the resistance of conveying the stent in the microcatheter is increased, and the dense-mesh stent is not easy to convey to the distal end by an operator.
Disclosure of Invention
In view of this, the present application proposes a low resistance delivery assembly comprising a delivery core wire, a hypotube, a binding tube, and a wire harness; the conveying core wire is fixedly arranged in the hypotube in a penetrating way; the outer wall of the proximal end side of the hypotube is sleeved with a binding tube, and the outer wall of the distal end side of the hypotube is suitable for being attached to a vascular stent; the wire harness is arranged in a penetrating mode to connect the hypotube with the wire binding tube, and the wire harness can bind the vascular stent.
In one possible implementation manner, the side wall of the hypotube is provided with a hollow groove, the side wall of the hypotube close to the far end is provided with a wire passing through hole, the wire passing through holes are oppositely arranged on the hypotube, and the wire harness passes through the wire passing through holes to penetrate through the hypotube.
In one possible implementation manner, the side wall, close to the distal end, of the hypotube is provided with hollow grooves, the hollow grooves are arranged in a spiral manner, and the arrangement intervals between the adjacent hollow grooves are gradually reduced from the proximal end direction to the distal end direction of the tube main body.
In one possible implementation manner, a developing end is arranged at the distal end of the hypotube, the developing end is made of developing materials, a cavity communicated with the interior of the hypotube is arranged at the proximal end of the developing end, and the distal end of the developing end is of an arc-shaped structure; the through line through hole is formed in the side wall of the far end of the hypotube.
In one possible implementation manner, the developing end is in a cylindrical structure, the outer diameter of the developing end is slightly larger than that of the hypotube, the proximal end of the developing end is welded and fixed with the hypotube, and the joint of the developing end and the hypotube is smoothly connected.
In one possible implementation manner, a wire fixing through hole is formed in the side wall of the wire binding pipe, the wire fixing through holes are oppositely formed in the wire binding pipe, and two ends of the wire harness are respectively fixed in different wire fixing through holes; one end of the wire harness is fixed to one of the wire fixing through holes, and the other end of the wire harness penetrates through the distal end of the hypotube and is fixed to the other wire fixing through hole.
In one possible implementation, the device further comprises a cutting member; the wire harness penetrates through the hypotube; the cutting piece with carry the core silk can dismantle the connection, just the cutting piece is located carry the distal end of core silk, the cutting piece with carry the terminal surface that the core silk links to each other has core silk connecting hole, the cutting piece has towards the cutting face of pencil.
In one possible implementation manner, a cutting line hole is formed in the middle of the cutting piece, and the cutting piece is turned right angles in the cutting line hole, so that the minimum inner edge of the cutting line hole forms an annular cutting edge; the wire harness is arranged in the secant hole in a penetrating mode.
In one possible implementation, the cutting element, the delivery core wire and the hypotube are coaxially arranged.
In one possible implementation, the cutting element is of a block-like structure, the cutting element extending distally with a coaxial segment; the distal end of coaxial section is the arcwall face, just coaxial section is the cylinder structure, coaxial section's diameter equals with the internal diameter of hypotube.
In one possible implementation, the developing device further comprises a developing ring; the developing ring is made of developing materials, is arranged on the hypotube, is positioned between the fixing points at the far end and the near end of the wire harness, and is provided with a threading channel, and the wire harness passes through the developing ring through the threading channel.
In one possible implementation, the developing ring includes a near point developing ring and a far point developing ring; the proximal end of the near point developing ring is adjacent to or abutted against the distal end of the binding-wire tube; the far point developing ring is arranged at a position close to the far end side of the hypotube.
In another aspect, the present application contemplates a stent delivery system comprising a low resistance delivery assembly, a vascular stent, and a catheter sheath as described in any of the above implementations; the vascular stent is sleeved on part of the low-resistance conveying component, and the vascular stent in a compressed state and the low-resistance conveying component are arranged in the catheter sheath together; wherein, vascular support cover is established the outer wall that the hypotube is close to the distal end, the pencil twines to vascular support's the outside.
In one possible implementation, the wire harness is helically wound around the periphery of the vascular stent.
The beneficial effects of this application: through wearing to establish in the hypotube and carry the core silk, and establish the binding tube at the proximal end side outer wall cover of hypotube, and wear to establish the pencil and connect hypotube and binding tube, as low resistance conveying component, establish the vascular support cover on the hypotube, the pencil is binded, the constraint from the outside of hypotube, be used for restricting the vascular support that is in the compression state radial holding power when carrying, thereby reduce vascular support and hold the extrusion force of state to sheath pipe or microcatheter under pressing, and then effectively reduce the resistance in the transportation. Moreover, under low resistance, the stress of the braided wire and the conveying core wire of the vascular stent is reduced during conveying, the vascular stent is not easy to deform, and the service life of the vascular stent is prolonged.
Other features and aspects of the present application will become apparent from the following detailed description of exemplary embodiments, which proceeds with reference to the accompanying drawings.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments, features and aspects of the present application and together with the description, serve to explain the principles of the present application.
FIG. 1 illustrates a cross-sectional view of a stent delivery system according to an embodiment of the present application;
FIG. 2 illustrates a cross-sectional view of a delivery core wire assembled with a cutting element according to an embodiment of the present application;
FIG. 3 shows a cross-sectional view of a hypotube according to an embodiment of the present application;
FIG. 4 illustrates a cross-sectional view of a low resistance delivery assembly according to an embodiment of the present application;
FIG. 5 illustrates a close-up view of a distal end of a hypotube in accordance with an embodiment of the present application;
FIG. 6 illustrates a perspective view of a near-point developing ring/far-point developing ring according to an embodiment of the present application;
FIG. 7 illustrates a close-up view of the distal end of a low resistance delivery assembly according to an embodiment of the present application;
FIG. 8 illustrates a close-up view of a proximal end of a low resistance delivery assembly according to an embodiment of the present application;
FIG. 9 illustrates a schematic view of a low drag delivery assembly winding a wire harness according to an embodiment of the present application;
FIG. 10 illustrates a schematic flow diagram of a proximal stent access sheath according to an embodiment of the present application;
FIG. 11 illustrates a front-to-back comparison of a cutting member cutting a distal end of a wire harness according to an embodiment of the present application;
FIG. 12 illustrates a schematic view of a partial release of a vascular stent according to an embodiment of the present application;
FIG. 13 illustrates a schematic view of a stent in accordance with an embodiment of the present application with a target vessel divided by a full release;
FIG. 14 is a schematic view showing a retraction procedure of a delivery system after implantation of a vascular stent according to an embodiment of the present application;
FIG. 15 illustrates a schematic view of a fully retracted delivery system after implantation of a vascular stent according to an embodiment of the present application;
fig. 16 shows a perspective view of a cutter according to an embodiment of the present application.
Detailed Description
Various exemplary embodiments, features and aspects of the present application will be described in detail below with reference to the accompanying drawings. In the drawings, like reference numbers indicate identical or functionally similar elements. Although various aspects of the embodiments are illustrated in the accompanying drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
It should be understood, however, that the terms "center," "longitudinal," "transverse," "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," and the like indicate or are based on the orientation or positional relationship shown in the drawings, and are merely for convenience of description or to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operated in a particular orientation, and therefore should not be construed as limiting the present application.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
The word "exemplary" is used herein to mean "serving as an example, embodiment, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.
In addition, numerous specific details are set forth in the following detailed description in order to provide a better understanding of the present application. It will be understood by those skilled in the art that the present application may be practiced without some of these specific details. In some instances, methods, means, elements, and circuits have not been described in detail as not to unnecessarily obscure the present application.
FIG. 1 illustrates a cross-sectional view of a stent delivery system according to an embodiment of the present application; FIG. 2 illustrates a cross-sectional view of a delivery core wire assembled with a cutting element according to an embodiment of the present application; FIG. 3 shows a cross-sectional view of a hypotube according to an embodiment of the present application; FIG. 4 illustrates a cross-sectional view of a low resistance delivery assembly according to an embodiment of the present application; FIG. 5 illustrates a close-up view of a distal end of a hypotube in accordance with an embodiment of the present application; FIG. 6 illustrates a perspective view of a near-point developing ring/far-point developing ring according to an embodiment of the present application; FIG. 7 illustrates a close-up view of the distal end of a low resistance delivery assembly according to an embodiment of the present application; FIG. 8 illustrates a close-up view of a proximal end of a low resistance delivery assembly according to an embodiment of the present application; FIG. 9 illustrates a schematic view of a low drag delivery assembly winding a wire harness according to an embodiment of the present application; FIG. 10 illustrates a schematic flow diagram of a proximal stent access sheath according to an embodiment of the present application; FIG. 11 illustrates a front-to-back comparison of a cutting member cutting a distal end of a wire harness according to an embodiment of the present application; FIG. 12 illustrates a schematic view of a partial release of a vascular stent according to an embodiment of the present application; FIG. 13 illustrates a schematic view of a stent in accordance with an embodiment of the present application with a target vessel divided by a full release; FIG. 14 is a schematic view showing a retraction procedure of a delivery system after implantation of a vascular stent according to an embodiment of the present application; FIG. 15 illustrates a schematic view of a fully retracted delivery system after implantation of a vascular stent according to an embodiment of the present application; fig. 16 shows a perspective view of a cutter according to an embodiment of the present application.
As shown in fig. 1-16, the low-resistance conveying assembly comprises a conveying core wire 10, a hypotube 20, a binding tube 30 and a wire harness 50, wherein the conveying core wire 10 is fixedly arranged in the hypotube 20 in a penetrating manner, the binding tube 30 is sleeved on the outer wall of the proximal end side of the hypotube 20, the outer wall of the distal end side of the hypotube 20 is suitable for being attached to a vascular stent 40, the wire harness 50 is connected with the hypotube 20 and the binding tube 30 in a penetrating manner, and the wire harness 50 can bind the vascular stent 40.
In this embodiment, the conveying core wire 10 is inserted into the hypotube 20, the binding wire tube 30 is sleeved on the outer wall of the proximal end side of the hypotube 20, and the wire harness 50 is inserted into and connected with the hypotube 20 and the binding wire tube 30, so that the vascular stent 40 is sleeved on the hypotube 20 as a low-resistance conveying component during conveying, the wire harness 50 binds and binds the vascular stent 40 in a compressed state from the outer side of the hypotube 20, so as to limit the radial supporting force of the vascular stent 40 during conveying, thereby reducing the extrusion force of the vascular stent 40 on a sheath tube or a micro-catheter in a press-holding state, further effectively reducing the resistance in the conveying process.
The proximal end as described herein is the end that is operated by the proximal operator and the distal end is the end that is proximal to the patient.
It is pointed out here that the low resistance conveying component in this application be applicable to more and carry mesh less, the fine close net support of wire, compare in prior art, from the scheme that close net support was carried to the distal end of internal support, the low resistance conveying component of this application adopts pencil 50 to bind this support from close net support's the outside, under the prerequisite of guaranteeing that the support is difficult for skew, deformation in the transportation, reduce radial holding power, more easily the operator carries the support to the distal end, low resistance conveying component is when using, the operability of operator is stronger for the operation is more controllable, and the security obtains promoting.
In one embodiment, the side wall of the hypotube 20 is provided with a hollow groove 21, the side wall of the hypotube 20 near the distal end is provided with a wire passing through hole 221, the wire passing through holes 221 are oppositely arranged on the hypotube 20, and the wire harness 50 passes through the hypotube 20 through the wire passing through holes 221.
In this embodiment, the side wall of the hypotube 20 is provided with a hollow groove 21, and the hollow groove 21 may be a straight groove structure perpendicular to the axial direction of the hypotube 20 or a spiral groove structure with a certain inclination angle, which is not particularly limited. The number of the through-line holes 221 is generally even, and the through-line holes 221 are disposed on opposite sides of the hypotube 20, which means that the angles of the straight lines connected by the through-line holes 221 disposed opposite to each other are flat angles, and the positions of the two holes are corresponding to each other on both sides of the hypotube 20, so that the wire harness 50 penetrates the hypotube 20 from the hypotube 20 in a radial direction.
Specifically, two oppositely disposed via holes 221 are provided in one group, and one or more groups are provided at the distal end of the hypotube 20. Preferably, the number of the through holes 221 is two, and the opposite arrangement is provided at the distal end of the hypotube 20, so as to facilitate the adjustment of the tightness of the wire harness 50.
In one embodiment, the side wall of the hypotube 20 near the distal end is provided with hollow grooves 21, and the hollow grooves 21 are spirally arranged, and the arrangement interval between the adjacent hollow grooves 21 is gradually reduced from the proximal end direction to the distal end direction of the tube body.
In this embodiment, the spacing between adjacent hollow grooves 21 decreases progressively from the proximal to the distal direction, the less stiff the distal end of hypotube 20, the more advantageous it is to pass through tortuous vessels.
In one embodiment, the distal end of the hypotube 20 is provided with a developing tip 22, the developing tip 22 is made of developing material, the proximal end of the developing tip 22 has a cavity communicating with the interior of the hypotube 20, the distal end of the developing tip 22 has an arc-shaped structure, and the wire passing through hole 221 is formed on the distal side wall of the hypotube 20.
In this embodiment, the through-line hole 221 is formed on the distal side wall of the hypotube 20, and in order to ensure that the operator can clearly observe the specific position of the distal end of the tool in the patient, the distal end of the hypotube is provided with the developing tip 22, and the developing tip 22 may be welded and fixed to the distal end of the hypotube 20, the developing tip 22 is disposed adjacent to the through-line hole 221, and the developing tip 22 is located at the distal end of the through-line hole 221.
In one embodiment, the developing end 22 is in a cylindrical structure, the outer diameter of the developing end 22 is slightly larger than the outer diameter of the hypotube 20, the proximal end of the developing end 22 is welded and fixed with the hypotube 20, and the connection between the developing end 22 and the hypotube 20 is smoothly connected.
In this embodiment, the developing tip 22 is fixedly connected to the hypotube 20, and the developing tip 22 is fixedly connected to the distal end of the hypotube 20 by laser welding.
In one embodiment, the side wall of the binding tube 30 is provided with a wire fixing through hole 31, the wire fixing through holes 31 are oppositely arranged on the binding tube 30, two ends of the wire harness 50 are respectively fixed in different wire fixing through holes 31, one end of the wire harness 50 is fixed to one of the wire fixing through holes 31, and the other end penetrates through the distal end of the hypotube 20 and is fixed to the other wire fixing through hole 31.
In this embodiment, the number of the wire fixing through holes 31 on the wire binding tube 30 is generally even, and the wire fixing through holes 31 are disposed on opposite sides of the wire binding tube 30, which means that the angles of the straight lines connected by the wire fixing through holes 31 disposed opposite to each other are flat angles, and the positions of the two holes are corresponding to each other on both sides of the wire binding tube 30, so that the wire harness 50 can be fixed on the wire binding tube 30. The universality of the low-resistance conveying assembly can be improved by fixing the wire through holes 31 at different positions on the wire binding tube 30 or adjusting the tightness of the wire harness 50 by the length of the wire harness 50, and 90% of the supports in the prior art can be recycled.
Preferably, one end of the wire harness 50 is fixed to one of the wire fixing through holes 31 of the wire binding tube 30, and the other end extends toward the distal end of the hypotube 20, passes through the wire passing through hole 221, radially penetrates the hypotube 20, and is finally fixed to the other wire fixing through hole 31 of the wire binding tube 30.
Preferably, the wire harness 50 is adhesively fixed to the wire binding tube 30.
The wire harness 50 is preferably made of a polymer wire or a material of a common medical device such as nickel titanium, and is not particularly limited.
In one embodiment, the wire harness 50 penetrates through the hypotube 20, the cutting member 11 is detachably connected with the conveying core wire 10, the cutting member 11 is located at the distal end of the conveying core wire 10, the end face of the cutting member 11 connected with the conveying core wire 10 is provided with a core wire connecting hole 113, and the cutting member 11 is provided with a cutting face facing the wire harness 50.
In this embodiment, a cutting member 11 is provided at the distal end of the delivery core wire 10, and after the assembly is delivered in place, the cutting member 11 is capable of cutting the distal wire harness 50 to facilitate subsequent release of the stent 40.
In one embodiment, the middle of the cutting member 11 is provided with a cutting line hole 111, and the cutting member 11 is chamfered in the cutting line hole 111 so that the smallest inner edge of the cutting line hole 111 forms an annular cutting surface, and the wire harness 50 is inserted into the cutting line hole 111.
In this embodiment, the cutting member 11 is provided with a cutting hole 111 in the middle, and preferably, the cutting member 11 is provided with cutting holes 111 at positions which are uniformly chamfered from opposite end surfaces of the opening to the middle, a sharp minimum inner edge is formed at the center of the cutting holes 111 as a ring-shaped blade, and the wire harness 50 is inserted into the cutting holes 111 to prepare for cutting action at a stage to be released.
In one embodiment, the cutting member 11, the delivery core wire 10 and the hypotube 20 are coaxially arranged.
It should be noted that, the cutting element 11, the conveying core wire 10, the hypotube 20 and the wire binding tube 30 sleeved outside the hypotube 20 are coaxial, so that the vascular stent 40 is easily delivered to the distal end by an operator on the premise of ensuring that the low-resistance conveying component and the vascular stent 40 do not deviate during conveying, and the conveying core wire 10 with the cutting element 11 is not easy to deform during the force application process of the operator, so that the service life of the conveying core wire 10 is prolonged.
In one embodiment, the cutting member 11 has a block structure, the cutting member 11 has a coaxial section 112 extending distally, the distal end of the coaxial section 112 has an arcuate surface, and the coaxial section 112 has a cylindrical structure, and the diameter of the coaxial section 112 is equal to the inner diameter of the hypotube 20.
In this embodiment, the distal end of the cutting member 11 has a coaxial section 112 in a cylindrical configuration, the diameter of the coaxial section 112 being equal to the inner diameter of the hypotube 20 to ensure that the distal end of the core wire 10 is delivered and that the cutting member 11 is coaxially disposed with the hypotube 20. In brief, the proximal end of the cutting member 11 is connected to the delivery core wire 10, the middle section has a secant hole 111, and the cylindrical structure of the distal side wall ensures high coaxiality with the hypotube 20.
In one embodiment, the developing device further comprises a developing ring, the developing ring is made of developing materials and is arranged on the hypotube 20, the developing ring is arranged between the fixing points at the far end and the near end of the wire harness 50, the developing ring is provided with a threading channel 25, and the wire harness 50 passes through the developing ring through the threading channel 25.
In this embodiment, the developing ring provided on the hypotube 20 is advantageous in that the operator can observe the condition in the patient from the outside at the time of delivery, and by judging whether the device is delivered in place or not through the position of the developing ring, the stent releasing operation can be performed and the precise operation of the cutting action of the wire harness 50 can be ensured.
Further, the main bodies of the near-point developing ring 24 and the far-point developing ring 23 are both ring-shaped structures. The threading passage 25 may be a threading hole formed in the developing ring in the proximal-distal direction, or may be a threading groove formed in the outer periphery of the developing ring in the axial direction thereof so that the wire harness 50 smoothly passes through the developing ring.
Preferably, the outer surfaces of the near-point developing ring 24 and the far-point developing ring 23 are provided with line grooves along the axial direction of the developing ring.
In one embodiment, the developing ring includes a near-point developing ring 24 and a far-point developing ring 23, the near end of the near-point developing ring 24 being adjacent to or abutting against the distal end of the binding-wire tube 30, the far-point developing ring 23 being disposed at a position near the distal end side of the hypotube 20.
In one embodiment, the distal end of the cutting head is cylindrical in configuration, coaxial with the inner diameter of the distal end of hypotube 20, and the proximal end has a core wire attachment aperture 113, and the distal end of delivery core wire 10 is inserted into core wire attachment aperture 113. The middle part of the cutting head is provided with an annular cutting edge which can cut off the wire harness 50.
In one embodiment, hypotube 20 is a multi-step reducing structure.
In one embodiment, the binder tube 30 is a multi-step reducing structure.
In the above two embodiments, the multi-step reducing structure gradually tapers from the proximal end to the distal end in the body, and the diameters of the hypotube 20 and the wound tube 30 also gradually decrease from the proximal direction to the distal direction.
In summary, the assembly process of the low resistance delivery assembly of the present application is: the cutting member 11 is fixed at the distal end of the conveying core wire 10, the cutting member and the cutting member are assembled and then inserted into the hypotube 20 together, the annular cutting edge on the cutting head coincides with the wire passing through hole 221 on the hypotube 20, the wire binding tube 30 is sleeved at the distal end of the hypotube 20, and the wire binding tube 30 is aligned with the proximal end of the near point developing ring 24 to form a conveying main body.
On the other hand, the present application further proposes a stent delivery system, which comprises the low-resistance delivery assembly, the stent 40 and the catheter sheath 60 described in any one of the above embodiments, wherein the stent 40 is sleeved on a part of the low-resistance delivery assembly, and the stent 40 in a compressed state is disposed in the catheter sheath 60 together with the low-resistance delivery assembly, wherein the stent 40 is sleeved on the outer wall of the hypotube 20 near the distal end, and the wire harness 50 is wound on the outer side of the stent 40.
In this embodiment, the stent 40 is simply bound by a thinner wire harness 50 on the outside of the stent during loading of the stent 40 to limit the radial support force of the stent 40 to the outer circumference, thereby reducing the pressing force on the sheath or microcatheter in the stent crimped state and thus reducing the resistance during delivery. After the stent is delivered to the position of the aneurysm 80 of the target vessel 70, the filaments binding the vascular stent 40 are cut off, the vascular stent 40 pushes out the microcatheter, and simultaneously, the operator pulls the wire harness 50 proximally to enable the vascular stent 40 to be in an unbound state after pushing out the microcatheter, and the vascular stent 40 in a compressed state can be expanded at the position of the aneurysm 80 in the target vessel 70, so that the release of the vascular stent 40 is completed.
It should be noted that, at the proximal end of the stent delivery system of the present application, an operation handle is provided, where the operation handle is connected with the luer connector at the proximal end of the microcatheter, and the operation handle is at least provided with a first operation portion for controlling the delivery core wire 10 to move independently in the distal end and the proximal end, a second operation portion for controlling the hypotube 20 to move independently in the distal end and the proximal end, and a third operation portion for controlling the binding tube 30 to move independently in the distal end and the proximal end, and a fourth operation portion for controlling the delivery core wire 10 and the hypotube 20 to move together in the distal end and the proximal end. The specific structure of the handle is not disclosed in the application, and the handle is only required to be ensured to be capable of realizing that the independent driving components can move, and the two components can move to the far end or the near end together within a certain limit, so that the specific structure of the handle is not limited.
The whole assembly process of the bracket conveying system is as follows:
the first step: the conveying main body passes through the guide sheath, and the position of the wire fixing through hole 31 on the wire binding tube 30 is exposed to the outer side of the distal end of the guide sheath; threading the stent 40 in its natural state on the delivery body; one end of the wire harness 50 is fixed in the wire fixing through hole 31, the wire is spirally wound from the proximal end to the distal end at the periphery of the vascular stent 40, after the distal end of the wire harness 50 penetrates through the wire fixing through hole 221 along the radial direction of the hypotube 20, the wire is reversely spirally wound at the periphery of the vascular stent 40 along the distal end to the proximal end direction, and finally the other end of the wire harness 50 is fixed in the wire fixing through hole 31 of the wire binding tube 30, and the wire winding process ensures that the wire is wound on the vascular stent 40.
And a second step of: the stent 40 is pressed into the introducer sheath together with the wire harness 50 thereon by a stent pressing device, specifically, the stent is gradually pressed into the introducer sheath with the wire harness 50 from the proximal end to the distal end by the stent pressing device, and finally the proximal end of the stent 40 is pressed into the introducer sheath.
And a third step of: the introducer sheath is held stationary and the delivery body is pulled proximally further, since the stent 40 is a braided or closed loop cut stent, the stent 40 itself has continuity, the proximal end of the stent has been cut in sheath and bound by the harness 50, the operator continues to pull the delivery body proximally, the stent and harness 50 thereon will be pulled fully into the introducer sheath, the stent 40 is in a compressed state, and fully into the introducer sheath.
Further, for using the stent delivery system, the specific procedure for releasing the vascular stent 40 to the location of the aneurysm 80 of the target blood vessel 70 is as follows:
the first step: the stent 40 is introduced through the introducer sheath into the microcatheter and the stent 40 is delivered through the microcatheter to the distal end of the microcatheter to the location of the aneurysm 80 of the target vessel 70.
And a second step of: holding the binding tube 30 in place, the operator pulls the delivery core wire 10 proximally, severing the distal end of the wire harness 50, at which point the wire harness 50 breaks away from its distal end as the cutting edge cuts into the wire harness 50.
And a third step of: after the distal end of the binding wire is cut off, the operator operates the conveying core wire 10 and the hypotube 20 to convey to the distal end together through the handle, meanwhile, the binding wire tube 30 is retracted, the wire harness 50 does not extend out of the microcatheter all the time, when the proximal end of the far-point developing ring 23 extends out of the microcatheter, the distal end of the vascular stent 40 gradually extends out of the microcatheter, and the vascular stent 40 gradually begins to be released;
fourth step: and step three, namely, relative to the microcatheter, the operator continues to distally convey the vascular stent 40 by operating the conveying core wire 10 and the hypotube 20 through the handle, simultaneously the wire binding tube 30 continues to be retracted, the vascular stent 40 is continuously released, and the action is stopped until the stent is completely released.
Fifth step: the delivery core wire 10, the hypotube 20 and the ligature tube are kept motionless relative to the microcatheter, the microcatheter is delivered distally along the hypotube 20, and the microcatheter is withdrawn from the vessel together after the distal end of the microcatheter exceeds the distal end of the delivery body, thereby completing implantation of the vascular stent 40.
In one embodiment, the wire harness 50 is helically wound around the circumference of the vascular stent 40.
In this embodiment, both ends of the wire harness 50 are respectively fixed in the wire fixing through holes 31 of the wire binding outer tube, the whole wire is wound on the bracket by a spiral winding manner, and is reversely wound on the bracket through the wire passing holes at the distal end of the hypotube 20, and the other end is fixed in the fixing holes of the wire binding outer tube. Because the binding tube 30 is sleeved on the hypotube 20, the binding tube can be pulled proximally along the hypotube 20, thereby tightening the wire harness 50 and further reducing the radial support force of the stent.
Moreover, the wire harness 50 is spirally wound around the periphery of the vascular stent 40, so that the wire harness 50 can tie the vascular stent 40, the stress is more uniform, and the vascular stent 40 has a certain compression amount on the premise of ensuring the whole shape of the vascular stent 40, and is easy for an operator to convey.
The embodiments of the present application have been described above, the foregoing description is exemplary, not exhaustive, and not limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the various embodiments described. The terminology used herein was chosen in order to best explain the principles of the embodiments, the practical application, or the improvement of technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims (14)

1. The low-resistance conveying assembly is characterized by comprising a conveying core wire, a hypotube, a binding tube and a wire harness;
the conveying core wire is fixedly arranged in the hypotube in a penetrating way;
the outer wall of the proximal end side of the hypotube is sleeved with a binding tube, and the outer wall of the distal end side of the hypotube is suitable for being attached to a vascular stent;
the wire harness is arranged in a penetrating mode to connect the hypotube with the wire binding tube, and the wire harness can bind the vascular stent.
2. The low resistance delivery assembly of claim 1, wherein the hypotube has a hollow channel formed in a side wall thereof, a through-wire via is formed in a side wall of the hypotube adjacent the distal end, the through-wire via being disposed opposite the hypotube, and the harness is threaded through the hypotube through the through-wire via.
3. The low-resistance delivery assembly according to claim 1, wherein hollow grooves are formed in the side wall, close to the distal end, of the hypotube, the hollow grooves are arranged in a spiral shape, and the arrangement intervals between adjacent hollow grooves are gradually reduced from the proximal end direction to the distal end direction of the tube main body.
4. The low resistance delivery assembly of claim 2, wherein the distal end of the hypotube is provided with a developing tip, the developing tip being of a developing material, the proximal end of the developing tip having a cavity in communication with the interior of the hypotube, the distal end of the developing tip being of a hemispherical configuration;
the through line through hole is formed in the side wall of the far end of the hypotube.
5. The low-resistance delivery assembly according to claim 4, wherein the developing tip has a cylindrical structure, the outer diameter of the developing tip is slightly larger than the outer diameter of the hypotube, the proximal end of the developing tip is welded to the hypotube, and the junction of the developing tip and the hypotube is smoothly connected.
6. The low-resistance conveying assembly according to claim 1, wherein a wire fixing through hole is formed in the side wall of the wire binding pipe, the wire fixing through holes are oppositely formed in the wire binding pipe, and two ends of the wire harness are respectively fixed into different wire fixing through holes;
one end of the wire harness is fixed to one of the wire fixing through holes, and the other end of the wire harness penetrates through the distal end of the hypotube and is fixed to the other wire fixing through hole.
7. The low resistance delivery assembly of claim 1, further comprising a cutter;
the wire harness penetrates through the hypotube;
the cutting piece with carry the core silk can dismantle the connection, just the cutting piece is located carry the distal end of core silk, the cutting piece with carry the terminal surface that the core silk links to each other has core silk connecting hole, the cutting piece has towards the cutting face of pencil.
8. The low drag delivery assembly of claim 7, wherein a cut line hole is formed in a middle portion of the cutting element and the cutting element is chamfered within the cut line hole such that a minimum inner edge of the cut line hole forms an annular facet;
the wire harness is arranged in the secant hole in a penetrating mode.
9. The low resistance delivery assembly of claim 7, wherein the cutting element, the delivery core wire, and the hypotube are coaxially disposed.
10. The low resistance delivery assembly of claim 9, wherein the cutting member is a block-like structure, the cutting member extending distally with a coaxial segment;
the distal end of coaxial section is the arcwall face, just coaxial section is the cylinder structure, coaxial section's diameter equals with the internal diameter of hypotube.
11. The low resistance transport assembly of claim 1, further comprising a developer ring;
the developing ring is made of developing materials, is arranged on the hypotube, is positioned between the fixing points at the far end and the near end of the wire harness, and is provided with a threading channel, and the wire harness passes through the developing ring through the threading channel.
12. The low resistance delivery assembly of claim 1, wherein the developing ring comprises a near point developing ring and a far point developing ring;
the proximal end of the near point developing ring is adjacent to or abutted against the distal end of the binding-wire tube;
the far point developing ring is arranged at a position close to the far end side of the hypotube.
13. A stent delivery system comprising the low resistance delivery assembly of any one of claims 1-12, a vascular stent, and a catheter sheath;
the vascular stent is sleeved on part of the low-resistance conveying component, and the vascular stent in a compressed state and the low-resistance conveying component are arranged in the catheter sheath together;
wherein, vascular support cover is established the outer wall that the hypotube is close to the distal end, the pencil twines to vascular support's the outside.
14. The stent delivery system of claim 13, wherein the wire harness is helically wound around the circumference of the vascular stent.
CN202310135815.XA 2023-02-17 2023-02-17 Low-resistance conveying assembly and bracket conveying system Active CN116212201B (en)

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