WO2023125010A1 - 输送系统 - Google Patents

输送系统 Download PDF

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Publication number
WO2023125010A1
WO2023125010A1 PCT/CN2022/139023 CN2022139023W WO2023125010A1 WO 2023125010 A1 WO2023125010 A1 WO 2023125010A1 CN 2022139023 W CN2022139023 W CN 2022139023W WO 2023125010 A1 WO2023125010 A1 WO 2023125010A1
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WO
WIPO (PCT)
Prior art keywords
sheath
handle
rear handle
sheath tube
distal end
Prior art date
Application number
PCT/CN2022/139023
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English (en)
French (fr)
Inventor
唐江峰
肖本好
Original Assignee
先健科技(深圳)有限公司
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Filing date
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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 WO2023125010A1 publication Critical patent/WO2023125010A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a delivery system.
  • Minimally invasive surgery for vascular repair with covered stents is widely used in the treatment of aortic vascular diseases due to its small trauma, fast recovery and good immediate effect.
  • the stent-graft is preloaded into the sheath of the delivery system, and then the stent is delivered to the lesion through the lumen of the human blood vessel through the delivery system, and then the stent is released from the sheath.
  • the stent isolates the blood flow from the vascular lesion to achieve the purpose of treatment.
  • the stent delivery system is the carrier of the stent, which is responsible for delivering the stent to the location of the vascular lesion, and is the key to the immediate success of the operation.
  • the existing stent delivery system generally consists of a sheath tube 2 , a tip 4 , a sheath core 3 , a handle assembly 1 , and a screw assembly 5 .
  • the distal end of the sheath tube 2 is relatively fitted to the Tip 4 before the sterilization treatment.
  • the front and rear handles in the handle assembly 1 are also relatively fitted to form the initial first a state.
  • the sheath tube 2 in the delivery system is usually composed of three layers, as shown in Figure 2, it is composed of an outer layer tube 2-3, an inner layer tube 2-1 and a middle layer spring tube 2-2. , wherein the outer layer tube 2-3 and the inner layer tube 2-1 are high-analysis materials, the middle layer spring tube 2-2 is made of metal material, and the middle layer of the front end of the sheath tube 2 is also provided with a developing ring structure 2-4.
  • the middle spring tube 2-2 is a helical metal spring, which tends to shrink, while the inner and outer polymer tubes tend to expand with heat and contract with cold during heating and cooling.
  • the temperature of the sterilization process is generally much higher than the room temperature. Therefore, the stent system needs to go through the process of heating and cooling during the sterilization and analysis process.
  • the sheath tube 2 tends to have a gap W between the step of the Tip head 4 and the front end of the sheath tube 2 as shown in the partially enlarged part of FIG. 3 .
  • the front port of the sheath tube 2 When there is a gap W between the tip 4 step and the front end of the sheath tube 2, the front port of the sheath tube 2 will be tilted up when the delivery system is pushed in the curved blood vessel, which may cause the risk of scratching the blood vessel. At the same time, the gap also affects The aesthetics of the entire conveying system.
  • the present invention proposes a delivery system, which aims to solve the problem that the front end of the sheath is tilted relative to the tip step and scratches the blood vessel.
  • the present invention provides a delivery system, which includes a handle, a sheath tube, a sheath core and a tip;
  • the handle includes a front handle and a rear handle which are oppositely arranged in the axial direction, and the rear handle can move back and forth relative to the front handle;
  • the distal end of the sheath core is connected to the Tip head, and the proximal end extends into the handle;
  • the sheath tube is coaxially sleeved outside the sheath core, and the proximal end of the sheath tube extends into the handle and It is connected with the rear handle; in the first state where the distal end surface of the sheath is attached to the Tip head, there is a reserved gap with an axial length of h1 between the front handle and the rear handle ; when the rear handle moves toward the front handle to narrow the reserved gap, the rear handle drives the sheath so that the distal end surface of the sheath is pressed against the Tip in a second state,
  • the Tip head includes a first part connected with the distal end of the sheath core and a second part connected with the distal end of the first part, the diameter of the proximal end of the second part is larger than the The diameter of the distal end of the first part, so that a step is formed at the connection between the second part and the first part, and the step has a step surface perpendicular to the axis of the sheath core; in the first state, the The distal end surface of the sheath is in contact with the stepped surface; in the second state, the distal end surface of the sheath is tightly pressed against the stepped surface.
  • a wedge-shaped groove inclined relative to the axis of the sheath core is provided at the junction of the stepped surface and the first part, and the distal end of the wedge-shaped groove is close to the axis of the sheath core while its proximal end is away from the axis of the sheath core;
  • the sheath includes a main body section and a connecting section coaxially connected to the distal end of the main body section, and the outer circumference of the connecting section is inclined inwardly so that the outer circumference of the connecting section is adapted to the wedge-shaped groove. Wedge;
  • the peripheral wedge of the connecting section can guide the connecting section into the wedge-shaped groove.
  • the inner circumference of the connecting section is inclined inwardly, and the outer circumference of the connecting section is inclined at the same angle as the inner circumference, so that the diameter of the connecting section is smaller than the inner diameter of the main body section.
  • the diameter of the connection section is greater than or equal to the maximum diameter of the first part.
  • part of the outer peripheral surface of the first portion is inclined inwardly relative to the axis of the sheath core, so that the outer diameter of the first portion gradually decreases from the proximal end to the distal end.
  • the inclination angle of part of the peripheral surface of the first portion relative to the axis of the sheath core is greater than or equal to 1° and less than or equal to 5°.
  • the maximum axial depth of the wedge-shaped groove is greater than or equal to 0.5 mm and less than or equal to 2 mm.
  • the connection between the proximal end of the sheath and the rear handle includes an axial fixed connection and an axial flexible connection; when the proximal end of the sheath is axially fixed relative to the rear handle, Then 2mm ⁇ h1 ⁇ 10mm; when the proximal end of the sheath is movably connected with the rear handle axially, the distance that the sheath can move axially relative to the rear handle is h2, then 2mm ⁇ h1-h2 ⁇ 10mm.
  • the handle is provided with an accommodating cavity, and the accommodating cavity is provided with a sheath tube joint, and the sheath tube joint includes an axial connection part and a diameter connected to the axial connection part.
  • the connecting part To the connecting part, the proximal end of the sheath extends into the accommodating cavity and is relatively fixed with the axial connecting part; a slot is provided in the cavity wall of the rear handle, and the radial connecting part extends The proximal end of the sheath tube is connected to the rear handle by entering the draw-in groove; wherein, when the axial distance of the draw-in groove is equal to the axial length of the radial connection part, the sheath tube The proximal end is axially relatively fixed to the rear handle; when the axial distance between the slots is greater than the axial length of the radial connection portion, the proximal end of the sheath is axially movably connected to the rear handle , the h2 is the maximum gap between the locking groove and the radial connecting
  • the hardness of the locking groove is greater than the hardness of the sheath tube.
  • a reserved gap is set between the front and rear handles in the first state, and the rear handle is moved to narrow the gap and drive the sheath tube to move so that the distal end of the sheath tube and the tip are slightly squeezed and tight, and the two sides A certain pre-tightening force is formed between them, so that during the pushing process, the pre-tightening force is used to prevent the distal end of the sheath from warping and avoid scratching the blood vessel.
  • the present invention can also use this reserved gap to compensate for the shortening of the sheath due to heating and cooling, so that the distal end of the sheath and the tip of the delivery system after treatment can still be tight , to further avoid the problem that the front end of the sheath tube is tilted and scratched the blood vessel due to the existence of the gap.
  • the front end of the sheath is constricted and the design of the wedge-shaped groove at the tip step can make the front end of the sheath and the tip step set a greater pre-tightening force without making the front end of the sheath wrap the tip step
  • the enlarged reserved gap between the front handle and the rear handle may accommodate a larger shortening deformation of the sheath, further reducing the risk of the gap and reducing the discomfort caused by the differential shortening question.
  • Fig. 1 is the sectional structure diagram of the first state of the existing conveying system
  • Fig. 2 is a partial cross-sectional structural schematic diagram of a sheath tube in an existing delivery system
  • Fig. 3 is the cross-sectional structure schematic diagram of existing conveying system after heating up and cooling and processing
  • Figure 4(a) is a schematic cross-sectional structural view of the first state of the delivery system according to Embodiment 1 of the present invention.
  • Figure 4(b) is a partial schematic diagram of the axial movable connection between the sheath tube joint and the rear handle;
  • FIG. 5 is a schematic cross-sectional view of the Tip head in the delivery system of Embodiment 1 of the present invention.
  • FIG. 6 is a schematic cross-sectional view of a sheath wrapped Tip in the delivery system according to Embodiment 1 of the present invention.
  • FIG. 7 is a schematic cross-sectional structural view of the first state of the delivery system according to Embodiment 2 of the present invention.
  • FIG. 8 is a schematic partial cross-sectional view of the Tip head in the delivery system of Embodiment 2 of the present invention.
  • FIG. 9 is a partial cross-sectional schematic diagram of the sheath tube in the delivery system according to Embodiment 2 of the present invention.
  • Fig. 10 is a schematic partial cross-sectional view of the first part of the Tip in the delivery system according to Embodiment 2 of the present invention, which is arranged obliquely;
  • FIG. 11 is a schematic cross-sectional structural view of the second state of the delivery system according to Embodiment 2 of the present invention.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as “inner”, “outer”, “inner”. “, “Outside”, “Below”, “Below”, “Above”, “Above”, etc.
  • Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” or “beneath” the other elements or features. feature above”. Thus, the example term “below” can encompass both an orientation of above and below.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • proximal end the end of the medical device implanted in the human body or animal body or the delivery system that transports the medical device that is closer to the operator
  • distal end the distance from the operator The far end
  • proximal end and distal end of any part of the medical device or delivery system are defined.
  • Axial generally refers to the length direction of the medical device when it is being transported
  • radial generally refers to the direction perpendicular to the "axial” of the medical device
  • axis" of any part of the medical device is defined according to this principle to” and "radial”.
  • the invention provides a delivery system, which includes a handle, a sheath tube, a sheath core and a Tip head;
  • the handle includes a front handle and a rear handle which are oppositely arranged in the axial direction, and the rear handle can move back and forth relative to the front handle;
  • the distal end of the sheath core is connected to The tip and the proximal end extend into the handle;
  • the sheath tube is coaxially sleeved outside the sheath core, and the proximal end of the sheath tube extends into the handle and is connected with the rear handle, wherein the connection between the proximal end of the sheath tube and the rear handle includes axial Fixed connection or axial movable connection.
  • the radial connection between the proximal end of the sheath tube and the rear handle is not limited, and the proximal end of the sheath tube and the rear handle can rotate relative to each other in the radial direction, and can also be relatively fixed in the radial direction.
  • the distal end surface of the sheath in the first state, is attached to the Tip, and there is a reserved gap with an axial length of h1 between the front handle and the rear handle.
  • the bonding in the present invention refers to adjacent contact without extrusion between each other.
  • the sheath is in a slightly compressed state, and the sheath is relatively fixed with the Tip head and the rear handle in the axial direction, so that the distance between the distal end surface of the sheath and the Tip Keep the squeeze tight.
  • the handle is provided with an accommodating cavity, and a sheath tube connector 13 is arranged in the accommodating cavity, and the sheath tube connector 13 includes an axial connection portion 131 and an axial connection portion 131.
  • the strength and hardness of the insertion groove are much greater than the hardness of the sheath tube when the insertion groove is provided, so as to ensure that the sheath tube is in a pre-tightened extrusion state.
  • the present invention exemplarily provides a delivery system, which includes a handle 10 , a sheath tube 20 , a sheath core 30 and a tip 40 .
  • a delivery system which includes a handle 10 , a sheath tube 20 , a sheath core 30 and a tip 40 .
  • the distal end surface of the sheath tube 20 is relatively attached to the Tip head 40, and there is a reserved gap with an axial length of h1 between the front handle 11 and the rear handle 12, wherein the axial length of the reserved gap is The length h1 is greater than 0, so that the sheath tube can be moved, and the extrusion of the fit state is called the tight state.
  • the axial length h1 of the reserved gap is greater than or equal to the shortening amount of the sheath tube 20 after the delivery system has experienced heating and cooling , so that the reserved gap can further compensate for the shortening of the sheath due to high temperature cooling, and further, when the sheath and the rear handle are axially movably connected, the axial length h1 of the reserved gap is greater than or equal to the shortening of the sheath And the amount of activity of the axial movement of the sheath.
  • the rear handle 12 can be moved forward so that the distal end surface of the sheath tube 20 is pressed against the Tip head 40.
  • the gap compensates for the shortening caused by the heating and cooling of the sheath tube 20, and avoids the problem that the front end of the sheath tube 20 lifts up and scratches the blood vessel due to the gap.
  • the handle 10 includes a front handle 11 and a rear handle 12 which are oppositely arranged in the axial direction. It can move back and forth relative to the front handle 11 on the screw rod 14, that is, the front handle 11 is located at the far end, and the rear handle 12 is located at the near end.
  • the handle 10 is provided with an accommodating cavity, and the accommodating cavity of the rear handle 12 is provided with a sheath tube connector 13 for connecting the sheath tube 20.
  • the sheath 20 connected to the rear handle 12 is movable following the axial movement of the handle 12 .
  • the sheath tube connector 13 can partially protrude from the rear handle 12 and be rotatable relative to the rear handle 12 , so that the sheath tube 20 can rotate with the rotation of the sheath tube connector 13 .
  • the way the sheath tube 20 is connected to the rear handle 12 is not limited to this.
  • the front handle and the rear handle are offset, and there is no gap between the two, while in the conveying system of this embodiment, referring to Figure 4 (a) As shown, there is a reserved gap with an axial length h1 between the front handle 11 and the rear handle 12, through which the shortening caused by the heating and cooling of the sheath tube 20 is compensated.
  • the axial length h1 of the gap reserved between the front handle 11 and the rear handle 12 should not be too long or too short. The reason is that h1 is too short and may not completely offset the shortening of the sheath tube 20 after the sterilization process, so there is still a gap after compensation. If h1 is too long, after the rear handle 12 moves and the front handle 11 is closed, the force exerted by the front end of the sheath tube 20 on the step of the Tip head 40 will be too large. Since the front end of the sheath tube 20 is a thin-walled polymer tube, the continuous force is easy The bell mouth is formed due to deformation, and the tip 40 steps are completely wrapped, as shown in Figure 6.
  • the sheath tube 20 When the Tip 40 is wrapped by the sheath tube 20, it will cause difficulty in exhausting the stent system before the operation, which will affect the normal operation.
  • the sheath tube when the proximal end of the sheath tube is axially fixed relative to the rear handle, then 2mm ⁇ h1 ⁇ 5mm; when the proximal end of the sheath tube is axially movably connected to the rear handle, the sheath tube can be The axial movement distance of the handle is h2, then 2mm ⁇ h1-h2 ⁇ 5mm.
  • the distal end of the sheath core 30 is connected to the Tip 40 , and the proximal end of the sheath core 30 extends into the handle 10 and passes through the handle 10 .
  • the sheath tube 20 is coaxially sleeved outside the sheath core 30, and the proximal end of the sheath tube 20 extends into the handle 10 and is connected with the rear handle 12 through the sheath tube joint 13, so that the sheath tube 20 can move axially after the handle 12;
  • the distal end surface of the sheath 20 is in contact with the Tip 40 , there is the above-mentioned reserved gap with an axial length of h1 between the front handle 11 and the rear handle 12 .
  • the Tip 40 includes a distal end connected to the sheath core 30.
  • the first part 41 and the second part 42 axially connected with the distal end of the first part 41, the proximal end diameter of the second part 42 is greater than the distal end diameter of the first part 41, so that at the joint of the second part 42 and the first part 41 A step is formed, and the step has a step surface 40a perpendicular to the axis X of the sheath core 30.
  • the distal end of the sheath tube 20 can be sleeved on the outer periphery of the first part 41, and the distal end surface of the sheath tube 20 is in line with the step
  • the faces 40a are relatively close to each other.
  • the first part 41 includes a leading section 41a and a socket section 41b connected together.
  • the guiding section 41a is located at the proximal end, and the sleeve section 41b is located at the distal end.
  • the outer peripheral contour of the guiding section 41a shrinks toward the sheath core 30, so that the distal end of the guiding sheath 20 is sleeved on the sleeve section 41b.
  • the distal end of the second part 42 located at the distal end shrinks toward the sheath core 30, so that its entry end is approximately tapered.
  • the radial thickness of the step is equal to the wall thickness of the sheath tube 20, so that the largest outer peripheral surface of the second part 42 is flush with the outer peripheral surface of the sheath tube 20 sleeved on the first part 41, which is convenient for the delivery system to enter the blood vessel process Scratches the blood vessel wall.
  • the end of the sheath can be pressed against the tip, and at the same time, the shortening caused by the heating and cooling of the sheath can be compensated, so that The sheath tube can be pressed against the Tip head before and after the treatment, which avoids the problem that the front end of the sheath tube 20 tilts up and scratches the blood vessel.
  • this embodiment is provided with a wedge-shaped groove 40a1 inclined relative to the axis X of the sheath core 30 at the junction of the stepped surface 40a and the first part 41, and the wedge-shaped groove
  • the distal end of the groove 40a1 is close to the axis X of the sheath core 30 and its proximal end deviates from the axis X of the sheath core 30.
  • the inclined wedge-shaped groove 40a1 is intended to guide the sheath tube 20 to enter on the one hand, and on the other hand to allow the sheath tube 20 to move axially.
  • the tip is embedded in the tip 40 to cooperate with the tip 40 , and the tip 40 can constrain the end of the sheath tube 20 .
  • the wedge-shaped groove 40a1 is connected with the first part 41 .
  • the step radially includes two parts, and the wedge-shaped groove 40a1 is close to the inner side
  • the outer circumference of the wedge-shaped groove 40a1 includes an abutment surface 40a2, and the connection between the abutment surface 40a2 and the wedge-shaped groove 40a1 can adopt a smooth transition, so that when the distal end surface of the sheath tube 20 touches the abutment surface 40a2, the When pushing axially, the distal end of the sheath tube 20 can smoothly slide into the wedge-shaped groove 40a1 , avoiding the formation of a flared mouth around the Tip 40 .
  • the maximum axial depth S of the wedge-shaped groove 40a1 is greater than or equal to 0.5mm and less than or equal to 2mm.
  • the distal end of the sheath tube 20 is set in a wedge shape that matches the wedge-shaped groove 40a1, so that the distal end of the sheath tube 20 enters the wedge-shaped groove 40a1.
  • the sheath tube 20 includes a main body section 21 and a connecting section 22 coaxially connected to the distal end of the main body section 21.
  • the connecting section 22 is located at the end of the main body section 21, and its length accounts for a small proportion.
  • the outer circumference of the connecting section 22 is inclined inwardly. , so that the outer circumference of the connecting section 22 is wedge-shaped to fit the wedge-shaped groove 40a1.
  • the connecting section 22 When the handle 12 of the sheath tube 20 moves toward the proximal end, the connecting section 22 is squeezed and its peripheral wedge-shaped guiding connecting section slides into the wedge-shaped groove 40a1 Inside, the wedge-shaped surface of the wedge-shaped groove 40a1 abuts against the peripheral wedge-shaped surface of the connecting section 22 to form a surface contact.
  • the front end of the sheath tube 20 is a thin-walled polymer tube, it is very difficult to provide a wedge shape that fits the wedge-shaped groove 40a1 on the outer periphery of the thin-walled tube.
  • the inner circumference of the connection 22 is also inclined inwardly, and the inclination angles of the outer circumference and the inner circumference of the connecting section 22 are equal, so that the entire connecting section 22 is inclined relative to the main body section 21.
  • only the front end of the existing thin-walled sheath tube 20 is slightly bent and heat-set to form the connecting section 22 inclined relative to the main section 21, which greatly reduces the difficulty and cost of the process.
  • the caliber D1 of the connecting section 22 is slightly smaller than the inner diameter of the main body section 21, and it is necessary to ensure that the sheath tube 20 can be sleeved on the Tip On the first part 41 of 40 , further referring to FIG. 10 , it is required that the diameter D1 of the connecting section 22 must be greater than or equal to the maximum diameter D2 of the first part 41 . However, if the caliber D1 of the connecting section 22 is smaller than the maximum diameter D2 of the first part 41 , assembly will be difficult and the release force of the stent may be increased.
  • the caliber D1 of the connecting section 22 must be greater than or equal to the maximum diameter D2 of the socket section 41b.
  • the reason for adopting the maximum diameter here is that when the outer surface of the sleeve section 41b is set flush, that is, the outer peripheral surface is not inclined relative to the axis X of the sheath core 30, then the diameters of each section on the sleeve section 41b are equal, and the maximum The diameter is equal to its actual radial length.
  • the connection section 22 when the outer surface of the sleeve section 41b is not flush, that is, the outer peripheral surface is arranged obliquely relative to the axis X of the sheath core 30, the radial lengths of each section on the sleeve section 41b are not equal, and there must be a maximum diameter , when the caliber D1 of the connection section 22 must be greater than or equal to the maximum diameter of the first part 41, then the connection section 22 must pass through the first part 41 so that the sheath tube 20 is sleeved on the first part 41 of the Tip 40.
  • the thickness t of the step of the Tip head 40 matches the wall thickness of the sheath tube 20, that is, the radial height of the step of the Tip head 40 is equivalent to the wall thickness of the sheath tube 20, then at the connecting section of the sheath tube 20
  • the inward bending of 22 it will cause when the sheath tube 20 is sleeved on the first part 41, the bent tip of the connecting section 22 will abut against the first part 41, and the outer diameter of the sheath tube 20 will be high. Excluding the outer diameter of the Tip head 40, the two are not flush, which will cause the raised part to scratch the blood vessel wall.
  • part of the outer peripheral surface of the first part 41 is inclined inwardly relative to the axis X of the sheath core 30, so that from the proximal end of the first part 41 to the Its outer diameter gradually decreases at the distal end.
  • part of the outer peripheral surface of the sleeve section 41b in the first part 41 is inclined inwardly relative to the axis X of the sheath core 30 .
  • the axis X is inclined inward with an inclination angle of ⁇ , so that its outer diameter gradually decreases from the proximal end to the distal end, so that the side wall of the wedge-shaped groove 40a1 close to the axis X of the sheath core 30 and the sleeve section of the first part 41
  • the distal end of 41b is smoothly transitioned to increase the size of the wedge-shaped groove 40a1 at the step of the Tip head 40 .
  • part of the outer peripheral surface of the sleeve section 41b of the first part 41 in this embodiment is inclined inwardly relative to the axis X of the sheath core 30, referring to the part of the outer peripheral surface of the sleeve section 41b near the distal end, while the sleeve The rest of the peripheral surface of the connecting section 41b near the proximal end is still arranged parallel to the axis X of the sheath core 30, that is to say, the sleeve section 41b includes an inclined section and a non-inclined section, and the non-inclined section at the proximal end is provided for the sheath When the tube is withdrawn, the small port of the sheath tube that is squeezed in front can be enlarged, thereby reducing the resistance of the sheath tube acting on the stent and reducing the release force of the stent.
  • the inclination angle ⁇ of the outer peripheral surface of the first part 41 relative to the axis X of the sheath core 30 cannot be too large or too small; if the inclination angle ⁇ is too large, the Tip 40 will be ejected from the mold because the Tip 40 is injection molded. Difficult, the inclination angle ⁇ is too small to effectively ensure that the outer diameter of the sheath tube 20 is flush with the outer diameter of the Tip head 40 after being sleeved.
  • the inclination angle ⁇ of the outer peripheral surface of the first part 41 relative to the axis X of the sheath core 30 The angle is greater than or equal to 1° and less than or equal to 5°. This angle not only satisfies the requirement that the outer circumference is flush, but also does not cause too much difficulty in demoulding the Tip head 40 .
  • the axial length h1 of the reserved gap existing between the front handle 11 and the rear handle 12 in this embodiment can be designed to be larger.
  • the proximal end of the sheath tube is axially fixed relative to the rear handle, then 2mm ⁇ h1 ⁇ 10mm;
  • the moving distance is h2, then 2mm ⁇ h1-h2 ⁇ 10mm.
  • the sheath tube 20 will be squeezed along the direction of the wedge-shaped groove 40a1 of the Tip head 40, and the connecting section 22 at the front end of the sheath tube 20 will shrink inwardly and enter the wedge-shaped groove 40a1 Inside, instead of expanding outwards and enveloping the Tip 40.
  • a reserved gap is set between the front and rear handles in the first state, and the rear handle is moved to narrow the gap and drive the sheath tube to move so that the distal end of the sheath tube and the tip are slightly squeezed and tight, and the two sides A certain pre-tightening force is formed between them, so that during the pushing process, the pre-tightening force is used to prevent the distal end of the sheath from warping and avoid scratching the blood vessel.
  • the present invention can also use this reserved gap to compensate for the shortening of the sheath due to heating and cooling, so that the distal end of the sheath and the tip of the delivery system after treatment can still be tight , to further avoid the problem that the front end of the sheath tube is tilted and scratched the blood vessel due to the existence of the gap.
  • the front end of the sheath is constricted and the design of the wedge-shaped groove at the tip step can make the front end of the sheath and the tip step set a greater pre-tightening force without making the front end of the sheath wrap the tip step
  • the enlarged reserved gap between the front handle and the rear handle may accommodate a larger shortening deformation of the sheath, further reducing the risk of the gap and reducing the discomfort caused by the differential shortening question.

Abstract

一种输送系统，包括手柄（10）、鞘管（20）、鞘芯（30）和Tip头（40）,其中手柄（10）包括轴向前后相对设置的前手柄（11）和后手柄（12）,后手柄（12）可相对前手柄（11）前后移动；鞘芯（30）的远端连接Tip头（40）,近端伸入手柄内；鞘管（20）同轴套接于鞘芯（30）夕卜，其近端伸入手柄（10）内并与后手柄（12）连接。在鞘管（20）的远端端面与Tip头（40）贴合的第一状态下，前手柄（11）和后手柄（12）之间存在轴向长度为hl的预留间隙，在后手柄（12）朝向前手柄（11）移动缩小预留间隙时，后手柄（12）带动鞘管（20）使得鞘管（20）的远端端面与Tip头（40）抵紧呈第二状态，在第二状态下鞘管（20）与Tip头（40）和后手柄（12）轴向相对固定。该输送系统解决了鞘管（20）前端相对Tip头（40）台阶翘起刮伤血管的问题。

Description

输送系统 技术领域
本发明涉及介入医疗器械技术领域，尤其涉及一种输送系统。
背景技术
覆膜支架血管修复微创手术由于创伤小，恢复快，即时效果好，被广泛运用于治疗主动脉血管疾病。在临床植入时，先将覆膜支架预装进输送系统的鞘管中，经人体血管管腔，通过输送系统将支架输送至病变位置后，再将支架从鞘管中释放出来。支架将血流与血管病变位置隔绝，达到治疗的目的。
支架输送系统是支架的载体，负责将支架输送至血管病变位置，是手术即刻成功的关键。如图1所示，现有的支架输送系统通常由鞘管2、Tip头4、鞘芯3、手柄组件1和螺杆组件5等结构组成。在输送系统装配完支架后灭菌处理前鞘管2的远端末端是与Tip头4相对贴合的，此时手柄组件1中的前后把手之间是也是相对贴合的，形成初始的第一状态。采用这种状态下的输送系统在输送弯曲过程中，贴合的鞘管前端相对Tip头台阶会翘起刮伤血管。更为严重的是，由于输送系统中的鞘管2通常由三层结构组成，如图2所示，分别为外层管2-3、内层管2-1和中层弹簧管2-2组成，其中外层管2-3和内层管2-1为高分析材料，中层弹簧管2-2为金属材料，在鞘管2前端中层还设置有显影环结构2-4。中层弹簧管2-2为螺旋的金属弹簧，有收缩的趋势，同时内外层高分子管受热和冷却过程容易出现热胀冷缩的显现。输送系统装配完支架后，需要进行灭菌处理，灭菌工艺温度一般远高于室温条件，因此灭菌及解析工艺，支架系统需要经历升温和冷却的过程。鞘管2在这个过程中容易出现如图3中局部放大部分所示的Tip头4台阶和鞘管2前端之间间隙W的情况。当Tip头4台阶和鞘管2前端之间出现间隙W时，输送系统在弯曲血管中推送过程中，鞘管2前端口更会翘起，存在导致刮伤血管 的风险，同时，间隙也影响整个输送系统的美观性。
发明内容
基于此，本发明提出一种输送系统，其旨在解决鞘管前端相对Tip头台阶翘起刮伤血管的问题。
为达此目的，本发明采用以下技术方案：
本发明提供一种输送系统，包括手柄、鞘管、鞘芯及Tip头；所述手柄包括轴向前后相对设置的前手柄和后手柄，所述后手柄可相对所述前手柄前后移动；所述鞘芯的远端连接所述Tip头、近端伸入所述手柄内；所述鞘管同轴套接于所述鞘芯外，所述鞘管的近端伸入所述手柄内并与所述后手柄连接；在所述鞘管的远端端面与所述Tip头贴合的第一状态下，所述前手柄与所述后手柄之间存在轴向长度为h1的预留间隙；在所述后手柄朝向所述前手柄移动缩小所述预留间隙时，所述后手柄带动所述鞘管使得所述鞘管的远端端面与所述Tip头抵紧呈第二状态，第二状态下所述鞘管与所述Tip头和所述后手柄轴向相对固定。
在其中一个实施例中，所述Tip头包括与所述鞘芯的远端相连的第一部分和与所述第一部分的远端相连的第二部分，所述第二部分的近端直径大于所述第一部分的远端直径，使得在所述第二部分与所述第一部分的相连处形成一台阶，所述台阶具有一与所述鞘芯的轴线垂直的台阶面；第一状态下，所述鞘管的远端端面与所述台阶面贴合；第二状态下，所述鞘管的远端端面与所述台阶面抵紧。
在其中一个实施例中，所述台阶面的与所述第一部分的相连处设有一相对所述鞘芯的轴线倾斜的楔形凹槽，所述楔形凹槽的远端靠近所述鞘芯的轴线而其近端远离所述鞘芯的轴线；
所述鞘管包括主体段及同轴连接于所述主体段远端的连接段，所述连接段的外周向内倾斜设置，使得所述连接段的外周呈与所述楔形凹槽适配的楔形；
在所述鞘管随所述后手柄朝向近端移动过程中，所述连接段的外周楔形可 引导所述连接段进入所述楔形凹槽内。
在其中一个实施例中，所述连接段的内周向内倾斜设置，所述连接段的外周与内周的倾斜角度相等，使得所述连接段的口径小于所述主体段的内径。
在其中一个实施例中，所述连接段的口径大于等于所述第一部分的最大直径。
在其中一个实施例中，所述第一部分的部分外周表面相对所述鞘芯的轴线向内倾斜，使得自所述第一部分的近端至远端其外径逐渐减小。
在其中一个实施例中，所述第一部分的部分外周表面相对所述鞘芯的轴线的倾斜角大于等于1°而小于等于5°。
在其中一个实施例中，所述楔形凹槽的轴向最大深度大于等于0.5mm而小于等于2mm。
在其中一个实施例中，所述鞘管的近端与所述后手柄连接包括轴向固定连接和轴向活动连接；当所述鞘管的近端与所述后手柄轴向相对固定时，则2mm≤h1≤10mm；当所述鞘管的近端与所述后手柄轴向活动连接时，所述鞘管可相对所述后手柄轴向移动的距离为h2，则2mm≤h1-h2≤10mm。
在其中一个实施例中，所述手柄内设有容置腔，所述容置腔内设有鞘管接头，所述鞘管接头包括轴向连接部和与所述轴向连接部连接的径向连接部，所述鞘管的近端伸入所述容置腔内并与所述轴向连接部相对固定；所述后手柄的腔壁内设有卡槽，所述径向连接部伸入所述卡槽内实现所述鞘管的近端与所述后手柄连接；其中，在所述卡槽的轴向间距等于所述径向连接部的轴向长度时，所述鞘管的近端与所述后手柄轴向相对固定；在所述卡槽的轴向间距大于所述径向连接部的轴向长度时，所述鞘管的近端与所述后手柄轴向活动连接，所述h2为所述卡槽与所述径向连接部之间的最大间隙。
在其中一个实施例中，所述卡槽的硬度大于所述鞘管的硬度。
本发明的输送系统在第一状态下的前后手柄之间设置预留间隙，通过移动后手柄来缩小间隙并带动鞘管移动从而使得鞘管远端与tip头之间微挤压 抵紧，两者之间形成一定的预紧力，从而在推送过程中，通过预紧力来防止鞘管远端翘起，避免刮伤血管。更重要的是，本发明还可通过这一预留间隙来补偿鞘管由于升温和冷却所带来的短缩量，使得经处理后的输送系统的鞘管远端与tip头依然可以抵紧，进一步避免了由于存在间隙而导致的鞘管前端翘起刮伤血管的问题。进一步，该输送系统中鞘管前端缩口和Tip头台阶处楔形凹槽的设计，可以使鞘管前端与Tip头台阶设置更大的预紧力，而不使鞘管前端包裹住Tip头台阶，同时加大的前手柄和后手柄之间的预留间隙，可能容纳更大的鞘管短缩变形量，进一步降低间隙带来的风险的同时降低了差异性短缩量所带来的不适问题。
附图说明
图1为现有输送系统第一状态的剖视结构示意图；
图2为现有输送系统中鞘管的局部剖视结构示意图；
图3为现有输送系统经升温和冷却和处理后的剖视结构示意图；
图4(a)为本发明实施例1的输送系统第一状态的剖视结构示意图；
图4(b)为鞘管接头与后手柄轴向活动连接的局部示意图；
图5为本发明实施例1的输送系统中Tip头的剖视示意图；
图6为本发明实施例1的输送系统中鞘管包裹Tip头的剖视示意图；
图7为本发明实施例2的输送系统第一状态的剖视结构示意图；
图8为本发明实施例2的输送系统中Tip头的局部剖视示意图；
图9为本发明实施例2的输送系统中鞘管的局部剖视示意图；
图10为本发明实施例2的输送系统中Tip头的第一部分倾斜设置的局部剖视示意图；
图11为本发明实施例2的输送系统第二状态的剖视结构示意图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，下面将参照附图更详细地描述本公开的示例性实施方式。虽然附图中显示了本公开的示例性实施 方式，然而应当理解，可以以各种形式实现本公开而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本公开，并且能够将本公开的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的，并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在，但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行，除非明确指出执行顺序。还应当理解，可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此，以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如，如果在图中的装置翻转，那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此，示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
另外，需要说明的是，在介入医疗器械领域，一般将植入人体或动物体内 的医疗器械或者输送该医疗器械的输送系统的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，并依据此原理定义医疗器械或者输送系统的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的与其“轴向”垂直的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
本发明提供一种输送系统，其包括手柄、鞘管、鞘芯及Tip头；手柄包括轴向前后相对设置的前手柄和后手柄，后手柄可相对前手柄前后移动；鞘芯的远端连接Tip头、近端伸入手柄内；鞘管同轴套接于鞘芯外，鞘管的近端伸入手柄内并与后手柄连接，其中，鞘管的近端与后手柄连接包括轴向固定连接或轴向活动连接。其中，此处对鞘管的近端与后手柄的径向上的连接并不做限定，鞘管的近端与后手柄径向上可相对转动，也可径向上相对固定。
本发明的输送系统，在第一状态下，鞘管的远端端面与Tip头贴合，前手柄与后手柄之间存在轴向长度为h1的预留间隙。本发明所述的贴合指相邻接触，彼此之间并不存在挤压。在后手柄朝向前手柄移动缩小预留间隙时，后手柄带动鞘管使得鞘管的远端端面与Tip头抵紧呈第二状态，此时的第二状态中鞘管的远端端面与Tip头挤压抵紧，两者之间存在预紧力，此时鞘管处于一个微压缩状，鞘管与Tip头和后手柄轴向相对固定，使得鞘管的远端端面与Tip头之间保持挤压抵紧的状态。其中，轴向长度h1大于0。应当说明的是，在第二状态下，前后手柄之间的预留间隙的轴向长度h1≥0，在h1＝0时，则第二状态下的鞘管的远端端面与Tip头抵紧，同时前后手柄之间不再存在间隙，前后手柄贴合。在h1＞0时，则第二状态下的鞘管的远端端面与Tip头抵紧，同时前后手柄之间仍然存在间隙，通过这一间隙可进一步补偿鞘管经历升温和冷却后鞘管的短缩量。
其中，当鞘管的近端与后手柄轴向相对固定时，则2mm≤h1≤10mm；当鞘管的近端与后手柄轴向活动连接时，鞘管可相对后手柄轴向移动的距离为h2，则2mm≤h1-h2≤10mm。
示例性的，参图4(a)和图4(b)手柄内设有容置腔，容置腔内设有鞘管接,13，鞘管接头13包括轴向连接部131和与轴向连接部131连接的径向连接部132，鞘管13的近端伸入容置腔内并与轴向连接部131相对固定；后手柄12的 腔壁内设有卡槽121，径向连接部132伸入卡槽121内实现鞘管的近端与后手柄连接；其中，在卡槽121的轴向间距m1等于径向连接部132的轴向长度m2时，鞘管的近端与后手柄轴向相对固定；在卡槽121的轴向间距m1大于径向连接部132的轴向长度m2时，鞘管的近端与后手柄轴向活动连接，h2为卡槽121与径向连接部132之间的最大间隙。其中，可理解的，为了能够形成挤压，在设置所述卡槽时，卡槽的强度和硬度远大于鞘管的硬度，从而保证鞘管处于预紧挤压的状态。
实施例1
参照图4(a)所示，本发明示例性的提供一种输送系统，所述输送系统包括手柄10、鞘管20、鞘芯30及Tip头40。在初始的第一状态下，鞘管20的远端端面与Tip头40相对贴合，前手柄11与后手柄12间存在轴向长度为h1的预留间隙，其中，预留间隙的轴向长度h1大于0，使得可以使鞘管移动将贴合状态挤压称为抵紧状态，优选的，预留间隙的轴向长度h1大于等于输送系统经历升温和冷却后鞘管20的短缩量，使得预留间隙可以进一步补偿鞘管因为高温冷却而导致的短缩量，进一步，当鞘管与后手柄轴向活动连接时，预留间隙的轴向长度h1大于等于鞘管的短缩量以及鞘管轴向移动的活动量。使得当输送系统经历升温和冷却后Tip头40台阶和鞘管20前端之间存在间隙时，可通过后手柄12向前移动使得鞘管20的远端端面与Tip头40抵紧，该预留间隙补偿了由于鞘管20升温和冷却所带来的短缩量，避免了由于存在间隙而导致的鞘管20前端翘起刮伤血管的问题。
具体的，继续参照图4(a)，手柄10包括轴向前后相对设置的前手柄11和后手柄12，后手柄12内穿设一螺杆14，前手柄11与螺杆14相对固定，后手柄12可在螺杆14上相对前手柄11前后移动，即前手柄11位于远端，后手柄12设于近端。手柄10内设有容置腔，后手柄12的容置腔内设有用于连接鞘管20的鞘管接头13，鞘管接头13与后手柄12轴向上相对固定，使得通过鞘管接头13与后手柄12连接的鞘管20可随后手柄12的轴向移动而移动。另外，鞘管接头13也可局部伸出后手柄12并相对后手柄12可转动，从而使得鞘管20可随鞘管接头13转动而转动。需要说明的是，鞘管20与后手柄12连接的方式 并不限于此。在输送系统第一状态，现有的输送系统中，如图1所示，前手柄和后手柄相抵，两者之间不存在间隙，而本实施例的输送系统中，参照图4(a)所示，前手柄11和后手柄12之间是存在一轴向长度为h1的预留间隙的，通过这一预留间隙以补偿由于鞘管20升温和冷却所带来的短缩量。
前手柄11和后手柄12之间预留间隙的轴向长度h1不宜太长或者太短。原因在于：h1太短，可能不能完全抵消鞘管20经过灭菌工艺的短缩量，从而在补偿后仍然存在间隙的情况。h1太长，后手柄12移动与前手柄11闭合后，鞘管20前端作用到Tip头40台阶处的力会偏大，由于鞘管20前端是薄壁的高分子管，持续的作用力容易导致变形而形成喇叭口，将Tip头40台阶完全包裹，如图6所示。当Tip头40被鞘管20包裹后会造成手术前支架系统排气操作困难，影响正常的手术。鉴于此，本实施例中，当鞘管的近端与后手柄轴向相对固定时，则2mm≤h1≤5mm；当鞘管的近端与后手柄轴向活动连接时，鞘管可相对后手柄轴向移动的距离为h2，则2mm≤h1-h2≤5mm。
继续参照图4(a)，鞘芯30的远端连接Tip头40，鞘芯30的近端伸入手柄10内并穿出手柄10。鞘管20同轴套设于鞘芯30外，鞘管20的近端伸入手柄10内并通过鞘管接头13与后手柄12连接，使得鞘管20可随后手柄12轴向移动；在输送系统第一状态，当鞘管20的远端端面与Tip头40相对贴合时，前手柄11与后手柄12间存在上述所述的轴向长度为h1的预留间隙。
示例性的，结合图4(a)和图5所示，作为鞘管20的远端端面与Tip头40相对贴合的一种实施方式，Tip头40包括与鞘芯30的远端相连的第一部分41和与第一部分41的远端轴向相连的第二部分42，第二部分42的近端直径大于第一部分41的远端直径，使得在第二部分42与第一部分41的相连处形成一台阶，台阶具有一与鞘芯30的轴线X垂直的台阶面40a，在装配完成后，鞘管20的远端可套设于第一部分41外周，且鞘管20的远端端面与台阶面40a相对贴合。
其中，第一部分41包括相连的引导段41a和套接段41b。引导段41a位于近端，套接段41b位于远端，引导段41a的外周轮廓朝向鞘芯30收缩，便于引导鞘管20的远端套接于套接段41b上。同样的，为了便于Tip头40引导输送系 统进入血管，位于远端的第二部分42的远端朝向鞘芯30收缩，使其进入端呈近似锥形。进一步的，台阶的径向厚度与鞘管20的壁厚相等，使得第二部分42的最大外周面与套接于第一部分41上的鞘管20的外周面齐平，便于输送系统进入血管过程中对血管壁造成刮伤。
本实施例的输送系统通过在前后手之间设置预留间隙，以此可以使得鞘管端部与tip头抵紧，同时还可以补偿由于鞘管升温和冷却所带来的短缩量，使得鞘管在处理前和处理后均可与Tip头抵紧，避免了鞘管20前端翘起刮伤血管的问题。
实施例2
在实际的设计过程中发现，由于鞘管20弹簧管密度一致性难以保证，同时内外层高分子管材存在一定差异性，经过灭菌工序后，短缩量变化差异性也较大，前手柄11和后手柄12之间预留间隙的轴向长度h1不太好确定。若预留太小，如图3所示，则会在前手柄11和后手柄12闭合后依然存在间隙，导致依然存在鞘管前端翘起刮伤血管的问题。而若预留太大，会存在如图6所示的Tip头40被鞘管20包裹，导致排气操作困难的问题，鉴于此，本实施例在实施例1的基础上进一步改进。
参照图7和图8所示，本实施例在实施例1的基础上，在台阶面40a的与第一部分41的相连处设有一相对鞘芯30的轴线X倾斜的楔形凹槽40a1，楔形凹槽40a1的远端靠近鞘芯30的轴线X而其近端偏离鞘芯30的轴线X，倾斜的楔形凹槽40a1一方面旨在引导鞘管20进入，另一方面使得鞘管20可轴向上嵌入Tip头40内与Tip头40配合，Tip头40可对鞘管20的末端进行约束。优选的，楔形凹槽40a1与第一部分41相连。另外，由于在初始装配完未处理的情况下，鞘管20的远端端面依然是与Tip头40的台阶面40a相对贴合，因此，台阶径向上包括两部分，楔形凹槽40a1是靠近内侧设置，在楔形凹槽40a1外周包括一周抵接面40a2，抵接面40a2与楔形凹槽40a1的连接处可采用圆滑过渡，便于在鞘管20的远端端面与抵接面40a2相抵时，受到轴向的推送时，鞘管20 的远端可顺畅的滑入楔形凹槽40a1内，而避免其形成喇叭口包裹Tip头40。优选地，由于Tip头40是注塑成型，因此，为了避免造成Tip头40脱模困难，如图8所示，楔形凹槽40a1的轴向最大深度S大于等于0.5mm而小于等于2mm。
参照图7和图9所示，基于上述楔形凹槽40a1的设置，鞘管20的远端处设置成与该楔形凹槽40a1配合的楔形状，从而便于鞘管20的远端进入楔形凹槽40a1。具体的，鞘管20包括主体段21及同轴连接于主体段21远端的连接段22，连接段22位于主体段21的末端，其长度占比较少，连接段22的外周向内倾斜设置，使得连接段22的外周呈与楔形凹槽40a1适配的楔形，在鞘管20随后手柄12朝向近端移动过程中，连接段22受挤压其外周楔形引导连接段滑入楔形凹槽40a1内，楔形凹槽40a1的楔形面与连接段22的外周楔形面抵接，形成面接触。
进一步地，继续参照图7和图9，由于鞘管20前端是薄壁的高分子管，因此，在薄壁的管的外周设置与楔形凹槽40a1适配的楔形的难度很大，鉴于此，本实施例中将连接,22的内周同样向内倾斜设置，且使连接段22的外周与内周的倾斜角度相等，这样就使得连接段22整体相对主体段21倾斜设置，在工艺的实现过程中，仅将现有的具有薄壁的鞘管20前端微微弯折并热定型即可形成相对主体段21倾斜的连接段22，极大的降低了工艺难度与成本。可理解的是，由于位于鞘管20末端的连接段22向内弯折形成，则就导致连接段22的口径D1略小于主体段21的内径，而要保证鞘管20可套接于Tip头40的第一部分41上，则进一步结合图10所示，要求连接段22的口径D1必须要大于等于第一部分41的最大直径D2。而若连接段22的口径D1如果小于第一部分41的最大直径D2就会造成装配困难，同时还可能增加支架释放力。应当注意的是，当第一部分41存在引导段41a和套接段41b时，则要求的是连接段22的口径D1必须要大于等于套接段41b的最大直径D2。此处采用最大直径的原因在于，当套接段41b的外表面齐平设置时，即外周表面相对鞘芯30的轴线X非倾斜设置，则套接段41b上的各段直径都相等，最大直径等于其实际的径向长度。但当套接段41b的外表面非齐平设置时，即外周表面相对鞘芯30的轴线X倾斜设置，则套接段41b上的各段径向长度不等，其中其必然存在一个最大直径，当连接 段22的口径D1必须大于等于第一部分41的最大直径时，则必然的连接段22是可穿过第一部分41使得鞘管20套接于Tip头40的第一部分41上。
结合图10和图11所示，由于Tip头40台阶的厚度t是与鞘管20壁厚相匹配，即Tip头40台阶径向高度与鞘管20壁厚相当，那么在鞘管20的连接段22的向内弯折设置时，则会导致当鞘管20套接在第一部分41上时，连接段22的弯折的尖部与第一部分41相抵，则会使得鞘管20的外径高出Tip头40的外径，两者不齐平，这样导致高出部分会对血管壁造成刮伤。因此，为了尽可能保证Tip头40外周与鞘管20外周齐平，在上述基础上，第一部分41的部分外周表面相对鞘芯30的轴线X向内倾斜，使得自第一部分41的近端至远端其外径逐渐减小。优选的，第一部分41中的套接段41b的部分外周表面相对鞘芯30的轴线X向内倾斜，此时，楔形凹槽40a1的靠近鞘芯30轴线X的侧壁也是相对鞘芯30的轴线X向内倾斜，其倾斜角为α，使得其近端至远端其外径逐渐减小，从而使得楔形凹槽40a1的靠近鞘芯30轴线X的侧壁与第一部分41的套接段41b的远端平滑过渡连接，以此来增大Tip头40台阶处楔形凹槽40a1的尺寸。这使得弯折的连接段22滑入楔形凹槽40a1后，在连接段22的口径轮廓与楔形凹槽40a1靠近鞘芯30轴线X的侧壁抵接时，Tip头40外周与鞘管20外周齐平，保证两者的相对连接处外表面的平滑度，便于输送系统顺畅进入血管，避免刮伤血管。另外，参照图10，本实施例中的第一部分41的套接段41b的部分外周表面相对鞘芯30的轴线X向内倾斜指套接段41b中的靠近远端的部分外周表面，而套接段41b的靠近近端的其余外周表面仍然相对鞘芯30的轴线X平行设置，也就是说，套接段41b包括倾斜段和无倾斜段，近端无倾斜段的设置，是为了在鞘管后撤时前面被挤压小的鞘管端口能被扩大，从而可以降低鞘管作用在支架上的阻力，降低支架的释放力。
优选地，第一部分41的外周表面相对鞘芯30的轴线X的倾斜角α不能太大也不能太小；倾斜角α太大，由于Tip头40是注塑成型，因此会成Tip头40脱模困难，倾斜角α太小，不能有效保证鞘管20在套接后其外径与Tip头40外径平齐，鉴于此，第一部分41的外周表面相对鞘芯30的轴线X的倾斜角α大于等于1°而小于等于5°，这一角度既满足了外周平齐的要求，同时并未给 Tip头40脱模造成太大难度。
基于上述结构的设置，本实施例的前手柄11与后手柄12之间存在的预留间隙的轴向长度h1可以设计的更大。本实施例中，当鞘管的近端与后手柄轴向相对固定时，则2mm≤h1≤10mm；当鞘管的近端与后手柄轴向活动连接时，鞘管可相对后手柄轴向移动的距离为h2，则2mm≤h1-h2≤10mm。参照图11，当前手柄11和后手柄12闭合后，鞘管20会沿着Tip头40的楔形凹槽40a1的方向挤压，鞘管20前端的连接段22向内内收缩进入楔形凹槽40a1内，而不会向外扩张而包裹住Tip头40。
本发明的输送系统在第一状态下的前后手柄之间设置预留间隙，通过移动后手柄来缩小间隙并带动鞘管移动从而使得鞘管远端与tip头之间微挤压抵紧，两者之间形成一定的预紧力，从而在推送过程中，通过预紧力来防止鞘管远端翘起，避免刮伤血管。更重要的是，本发明还可通过这一预留间隙来补偿鞘管由于升温和冷却所带来的短缩量，使得经处理后的输送系统的鞘管远端与tip头依然可以抵紧，进一步避免了由于存在间隙而导致的鞘管前端翘起刮伤血管的问题。进一步，该输送系统中鞘管前端缩口和Tip头台阶处楔形凹槽的设计，可以使鞘管前端与Tip头台阶设置更大的预紧力，而不使鞘管前端包裹住Tip头台阶，同时加大的前手柄和后手柄之间的预留间隙，可能容纳更大的鞘管短缩变形量，进一步降低间隙带来的风险的同时降低了差异性短缩量所带来的不适问题。
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 (11)

  1. 一种输送系统，其特征在于，包括手柄、鞘管、鞘芯及Tip头；所述手柄包括轴向前后相对设置的前手柄和后手柄，所述后手柄可相对所述前手柄前后移动；所述鞘芯的远端连接所述Tip头、近端伸入所述手柄内；所述鞘管同轴套接于所述鞘芯外，所述鞘管的近端伸入所述手柄内并与所述后手柄连接；在所述鞘管的远端端面与所述Tip头贴合的第一状态下，所述前手柄与所述后手柄之间存在轴向长度为h1的预留间隙；在所述后手柄朝向所述前手柄移动缩小所述预留间隙时，所述后手柄带动所述鞘管使得所述鞘管的远端端面与所述Tip头抵紧呈第二状态，第二状态下所述鞘管与所述Tip头和所述后手柄轴向相对固定。
  2. 根据权利要求1所述的输送系统，其特征在于，所述Tip头包括与所述鞘芯的远端相连的第一部分和与所述第一部分的远端相连的第二部分，所述第二部分的近端直径大于所述第一部分的远端直径，使得在所述第二部分与所述第一部分的相连处形成一台阶，所述台阶具有一与所述鞘芯的轴线垂直的台阶面；第一状态下，所述鞘管的远端端面与所述台阶面相对贴合；第二状态下，所述鞘管的远端端面与所述台阶面抵紧。
  3. 根据权利要求2所述的输送系统，其特征在于，所述台阶面的与所述第一部分的相连处设有一相对所述鞘芯的轴线倾斜的楔形凹槽，所述楔形凹槽的远端靠近所述鞘芯的轴线而其近端远离所述鞘芯的轴线；
    所述鞘管包括主体段及同轴连接于所述主体段远端的连接段，所述连接段的外周向内倾斜设置，使得所述连接段的外周呈与所述楔形凹槽适配的楔形；
    在所述鞘管随所述后手柄朝向近端移动过程中，所述连接段的外周楔形可引导所述连接段进入所述楔形凹槽内。
  4. 根据权利要求3所述的输送系统，其特征在于，所述连接段的内周向内倾斜设置，所述连接段的外周与内周的倾斜角度相等，使得所述连接段的口径小于所述主体段的内径。
  5. 根据权利要求4所述的输送系统，其特征在于，所述连接段的口径大于等于所述第一部分的最大直径。
  6. 根据权利要求5所述的输送系统，其特征在于，所述第一部分的部分外周表面相对所述鞘芯的轴线向内倾斜，使得自所述第一部分的近端至远端其外径逐渐减小。
  7. 根据权利要求6所述的输送系统，其特征在于，所述第一部分的部分外周表面相对所述鞘芯的轴线的倾斜角大于等于1°而小于等于5°。
  8. 根据权利要求3所述的输送系统，其特征在于，所述楔形凹槽的轴向最大深度大于等于0.5mm而小于等于2mm。
  9. 根据权利要求1～8任一所述的输送系统，其特征在于，所述鞘管的近端与所述后手柄连接包括轴向固定连接或轴向活动连接；当所述鞘管的近端与所述后手柄轴向相对固定时，则2mm≤h1≤10mm；当所述鞘管的近端与所述后手柄轴向活动连接时，所述鞘管可相对所述后手柄轴向移动的距离为h2，则2mm≤h1-h2≤10mm。
  10. 根据权利要求9所述的输送系统，其特征在于，所述手柄内设有容置腔，所述容置腔内设有鞘管接头，所述鞘管接头包括轴向连接部和与所述轴向连接部连接的径向连接部，所述鞘管的近端伸入所述容置腔内并与所述轴向连接部相对固定；所述后手柄的腔壁内设有卡槽，所述径向连接部伸入所述卡槽内实现所述鞘管的近端与所述后手柄连接；其中，在所述卡槽的轴向间距等于所述径向连接部的轴向长度时，所述鞘管的近端与所述后手柄轴向相对固定；在所述卡槽的轴向间距大于所述径向连接部的轴向长度时，所述鞘管的近端与所述后手柄轴向活动连接，所述h2为所述卡槽与所述径向连接部之间的最大间隙。
  11. 根据权利要求10所述的输送系统，其特征在于，所述卡槽的硬度大于所述鞘管的硬度。
PCT/CN2022/139023 2021-12-31 2022-12-14 输送系统 WO2023125010A1 (zh)

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