WO2019128806A1 - 主动脉支架的输送释放装置 - Google Patents

主动脉支架的输送释放装置 Download PDF

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Publication number
WO2019128806A1
WO2019128806A1 PCT/CN2018/122095 CN2018122095W WO2019128806A1 WO 2019128806 A1 WO2019128806 A1 WO 2019128806A1 CN 2018122095 W CN2018122095 W CN 2018122095W WO 2019128806 A1 WO2019128806 A1 WO 2019128806A1
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WO
WIPO (PCT)
Prior art keywords
handle
delivery
sliding handle
aortic stent
release device
Prior art date
Application number
PCT/CN2018/122095
Other languages
English (en)
French (fr)
Inventor
王永胜
李建民
吴世超
符伟国
Original Assignee
杭州唯强医疗科技有限公司
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Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Publication of WO2019128806A1 publication Critical patent/WO2019128806A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a delivery and release device for treating a stent of an aortic aneurysm and aortic dissection.
  • Aortic diseases mainly include aortic true aneurysms, aortic pseudoaneurysms, and aortic dissection aneurysms.
  • the aortic true aneurysm is not a true tumor, but a local or general expansion of the aorta due to various reasons, and the aortic diameter is greater than 50% of the normal diameter of the pathological changes.
  • Aortic pseudoaneurysm is the tearing or piercing of the arterial wall, from which the blood flows out and is surrounded by tissue adjacent to the aorta to form a hematoma, mostly due to trauma.
  • Aortic dissection aneurysm is due to local aortic insufficiency, high pressure blood flow into the vessel wall, causing a tear in the middle membrane (the middle layer is usually split in the middle layer 1/3 and the outer 2/3 interface)
  • the intact aortic wall structure is divided into two, forming a sandwich cavity in the cleavage gap between the inner and outer walls of the interlayer.
  • the mezzanine cavity is called a pseudocavity
  • the aortic cavity is called a true cavity.
  • Aortic true aneurysms and aortic dissection aneurysms are extremely dangerous diseases.
  • the mortality rate is more than 50% within 48 hours after onset, and the mortality rate is more than 85% within two weeks after onset, which has seriously threatened human health. With the advent of China's aging trend, its incidence will continue to rise.
  • a stent is implanted in the aortic lesion for treatment.
  • the stent is implanted by compressing the stent into the delivery release device, then guiding the guide wire through the minimally invasive incision of the femoral artery, and then guiding the stent to the aorta via the delivery system along the guide wire previously implanted into the human body.
  • the stent is released and implanted into the lesion.
  • Patent document CN102488576A discloses a delivery and release device for a stent graft, which adjusts the rotary handle to drive the threaded connector to move axially along the guidewire tube, where the adjustment handle is not provided with a control switch when the operator is During the use of the conveyor, it is highly probable that the adjustment handle rotates the adjustment handle here. If the bracket has not reached the release requirement, the proximal end or the distal end of the adjustment handle adjustment has been released, resulting in the release of the bracket. The position is not accurate, and eventually it will have very serious consequences. The release of the bracket fails.
  • the invention provides a stent delivery device with simple operation, release control, safety and reliability.
  • a delivery release device for an aortic stent comprising a sheath core assembly, an outer sheath tube and a control handle for controlling axial movement of the sheath core assembly and the outer sheath tube;
  • the control handle comprising a support body, a fixed handle and a movable sleeve a sliding handle on the support body, the outer sheath tube being coupled to the sliding handle, the sheath core assembly being coupled to the support body, the sliding handle sliding axially relative to the support body and circumferentially rotating, depending on the axis of the sliding handle
  • the sliding handle and the fixed handle have an axial abutting state and a separated state; in the abutting state, the sliding handle and the fixed handle are rotationally engaged in a line contact manner.
  • the fixed handle and the sliding handle have a matching contact portion.
  • the contact area is excessively generated to generate a large rotational resistance.
  • the fixed handle and the sliding handle generally adopt a split structure, and the resistance is too large. Causes the circumferential resistance to unscrew during the process of stress, causing the release failure during use.
  • the fixed handle of the present invention and the sliding handle are rotationally coupled in line contact, which can greatly reduce the resistance and potential safety risks.
  • a locking mechanism for holding the sliding handle in an abutting state is provided on the fixed handle.
  • the locking mechanism on the one hand defines the axial position of the sliding handle and, in addition, allows the sliding handle to rotate.
  • the locking mechanism on the fixed handle comprises:
  • the hook is driven to lock the drive spring of the sliding handle.
  • the fixed handle in order to maintain the axial position of the sliding handle when operating, the fixed handle is provided with a hook.
  • the sliding handle generally changes the position of the outer sheath by rotating and threading the linkage, and at the same time In the quick adjustment, the sliding handle is directly pushed and pulled in the axial direction.
  • the focus of the hook in the invention is to limit the axial position of the sliding handle, and the sliding handle can be allowed to rotate around the axis of the control handle as needed.
  • the release button and the hook are disposed on the fixed handle, and the unlocking button can be prevented from being triggered by mistake when the sliding handle is operated, thereby further improving safety.
  • the proximal end refers to the end of the surgical operator, that is, the side away from the lesion.
  • the distal end refers to the end of the operator away from the operator, that is, the side close to the lesion.
  • the side of the fixed handle adjacent to the sliding handle is a proximal end portion of the outer circumference of the support body, and the proximal end portion is provided with a mounting hole, and the release button is provided. Embedded in the mounting hole.
  • a part of the release button is exposed in the area of the mounting hole for pressing operation, and a non-slip line may be provided on the release button.
  • the shape of the release button in the present invention is not strictly limited.
  • the release button and the hook are fixedly connected, matched or integrated.
  • the sliding handle is provided with a positioning groove for receiving the hook.
  • the positioning groove can accommodate and restrain the hook therein, and the positioning groove can be provided integrally with the sliding handle or can be additionally installed. Since the fixing handle has a contact portion with the sliding handle, the groove of the positioning groove can be The hook is received in position, and a part of the groove wall blocks the hook from exiting.
  • the part of the groove wall is preferably at the end face of the distal end of the sliding handle, and the end face is provided with an opening so that the hook protrudes into the positioning groove through the opening,
  • the portion of the groove wall can also be considered equivalently as a blocking member that cooperates with the hook to maintain the axial position after the buckle is in place.
  • the positioning groove is an annular shape distributed around the axis of the control handle, and is rotated and matched with the hook and axially restricted.
  • the positioning groove is annular and distributed on the inner wall of the sliding handle, and when the sliding handle is rotated, no positional interference with the hook is generated, but the axial positioning is always maintained.
  • the drive spring is pressed between the release button and the outer wall of the support body.
  • One side of the fixed handle adjacent to the sliding handle is fixedly sleeved on the outer circumference of the supporting body, one end of the driving spring is opposite to the release button, and the other end directly abuts against the outer circumference of the supporting body.
  • the releasing button is opposite to the supporting body.
  • At least one of the driving springs is provided with a positioning post or a positioning hole, and the end of the driving spring is sleeved on the positioning post or placed in the positioning hole.
  • the position of the release button opposite to the support body is provided with a positioning post, and the driving spring is a coil spring, and the two ends are respectively sleeved on the corresponding positioning posts to prevent offset or misalignment when the pressure is applied.
  • the fixed handle is fixed on the support body and located on the distal end side of the sliding handle, and the side of the fixed handle adjacent to the sliding handle is fixedly sleeved at the proximal end of the outer circumference of the support body, and the sliding handle is locked by the hook In the state, the proximal end surface of the fixed handle and the axial end surface of the sliding handle are rotatably engaged in a line contact manner.
  • At least one of the proximal end face of the fixed handle and the axial end face of the sliding handle has a friction reducing collar disposed about the axis of rotation of the sliding handle.
  • the drag reducing rings on the two are arranged in a dislocation in the radial direction to avoid interference.
  • the drag reducing ring is continuously extended or intermittently distributed.
  • the drag ring In the circumferential direction, the drag ring can be continuously extended or intermittently distributed, and the contact area can be further reduced when the distribution is intermittent.
  • the circumferential ends of each of the drag reducing rings are generally rounded to avoid local tip.
  • the convex top of the drag reducing ring is curved or ribbed.
  • the form of the line contact may be a convex ring.
  • the shape of the convex portion may be a sharp angle or an arc shape, and the line contact may be realized by the sharp corner or the top position of the arc, and the curved shape is preferably adopted.
  • the drag reducing rings are at least two channels arranged concentrically.
  • the proximal end of the fixed handle is sleeved with a rotating cover, and the proximal end surface of the rotating cover is rotatably engaged with the axial end surface of the sliding handle in a line contact manner.
  • the proximal end portion of the rotating cover and the fixed handle may be in a threaded manner, etc., and the rotating cover, that is, the partial split structure, is provided to make the component more convenient for disassembly and maintenance, and the line contact may be in the form of the drag reducing convex ring described above.
  • the distal end of the sliding handle is sleeved with a rotating cover, and the distal end surface of the rotating cover is rotatably engaged with the axial end surface of the fixed handle in a line contact manner.
  • the distal end of the rotating cover and the sliding handle may be in a threaded manner, etc., and the rotating cover, that is, the partial split structure, is provided to make the component more convenient for disassembly and maintenance.
  • the wire contact may be in the form of a drag reducing collar as described above.
  • the rotating cover is threadedly engaged with the distal end side of the sliding handle, the distal end side of the rotating cover is turned inward, and the proximal end side of the burring portion forms the positioning groove.
  • the supporting body is an axial through structure, and the side wall is provided with a sliding groove extending in the axial direction, and the proximal side of the outer sheath tube Extending into the support body and fixing a linkage, a portion of the linkage extends radially out of the slot and is threadedly engaged with the inner wall of the sliding handle.
  • the sliding handle has an internal thread, which can drive the linkage to drive the outer sheath tube to move axially, and the axially extending sliding groove can guide and limit the circumferential position of the linkage to prevent the linkage and the outer sheath.
  • the tube turns.
  • the sliding handle is of a two-layer structure, wherein the inner layer is threadedly engaged with the linkage.
  • the double-layer structure can meet the strength requirement and the weight reduction.
  • the split fit can be adopted to facilitate assembly and avoid space interference.
  • the sliding handle is provided with a transparent material or a hollow observation window at a position corresponding to the linkage.
  • the sliding handle is provided with a scale indicating the relative position of the linkage.
  • the position of the linkage can also be identified during operation by the viewing window in combination with the scale, i.e., the position of the outer sheath relative to the sheath core assembly to guide the release state of the access device.
  • the sheath core assembly comprises an inner sheath core and an outer sheath core tube, the outer sheath core tube being slidably sleeved outside the inner sheath core.
  • the sheath core assembly of the present invention may adopt prior art, for example, an inner sheath core and an outer sheath core tube which are nested inside and outside and which are relatively axially slidable, and the outer sheath tube is located on the outer circumference of the outer sheath core tube, and the control handle may be disposed An outer sheath core adjusting mechanism that drives the outer sheath core tube to slide axially relative to the inner sheath core.
  • the present invention can maintain the axial relative position when operating the sliding handle by providing a locking mechanism on the fixed handle, avoiding unnecessary separation to improve safety, and further adopting a line contact between the fixed handle and the sliding handle. Reduces drag, improves smoothness and feel of the operation, and avoids the risk of component disintegration.
  • Figure 1 is a schematic structural view of a delivery release device of the present invention
  • FIG. 2 is a schematic structural view of a sliding handle
  • Figure 3 is a cross-sectional view of the transport release device of Figure 1;
  • Figure 4 is a cross-sectional view of the conveying release device of Figure 1 at another angle;
  • Figure 5 is an enlarged view of a portion A in Figure 3;
  • Figure 6 is an enlarged view of a portion B of Figure 5;
  • Figure 7 is a front elevational view of the rotary cover
  • Figure 8 is an enlarged view of a portion C of Figure 5;
  • Figure 9 is an enlarged view of a portion D of Figure 5.
  • the delivery release device of the present invention comprises a sheath core assembly, an outer sheath tube 7 and a control handle for controlling relative axial movement of the sheath core assembly and the outer sheath tube 7, the distal end of the sheath core assembly being connected conical TIP head (boot head) 1.
  • the control handle includes a support body 17, a fixed handle 9 mounted on the support body 17, and a sliding and rotatable sliding handle 16 sleeved on the support body 17, wherein the outer sheath tube 7 is coupled to the sliding handle, the sheath core assembly and the support body 17 is connected, and a locking mechanism is provided between the fixed handle 9 and the sliding handle 16 to cooperate with each other to maintain the axial position of the sliding handle 16.
  • the locking handle 10 of the locking mechanism is provided on the fixed handle 9.
  • the sliding handle 16 has a double-layer structure, which can increase the support strength and is easy to operate.
  • the outer layer has an observation window 16a and a scale mark 16b, and the inner layer is a transparent material, which can still pass through the inner strength while increasing the support strength.
  • the position of the teeth indirectly determines the length of the sheath released by the stent.
  • the distal end side of the slide handle 16 is screwed with a rotary cover 13, and the end surface of the distal end portion of the rotary cover 13 is rotatably fitted in line contact with the axial end surface of the proximal end side of the fixed handle 9.
  • the distal end side of the fixed handle 9 is threaded with a fixed handle screw cap.
  • Bracket fixing assembly (only for temporary labeling, the same below)
  • a hollow tube is axially formed in a middle portion of the TIP head 1;
  • the sheath core assembly includes an inner sheath core 4 and an outer sheath core tube 5 which are nested inside and outside and are axially slidable, and the inner sheath core 4 has the same end as the TIP head.
  • the tail end of 1 is fixedly connected and communicates with the hollow tube passage of the TIP head 1 described above; the other end of the inner sheath core 4 extends into the control handle, and the control handle correspondingly sets the fixing mechanism of the inner sheath core 4.
  • the outer sheath core tube 5 is placed on the outer wall of the inner sheath core 4, and can slide along the outer wall of the inner sheath core, and the outer sheath tube 7 is sleeved outside the outer sheath core tube 5, and can slide along the outer side of the outer sheath core, For loading the covered bracket.
  • a bracket fixing component is disposed adjacent to the TIP head 1 , including a fixing anchor 2 and a barb 3 , and the fixing anchor 2 is fixedly connected with the distal end of the outer sheath core tube 5 , and has a claw-like structure, and the barb 3 and the inner sheath core 4 are spot-welded and fixed.
  • the connection is further molded with the TIP head 1 and the bracket fixing component can be used for positioning the proximal end of the stent graft, wherein the anchor anchor 2 fixes the proximal end of the stent, and the barb 3 positions the stent.
  • the outer sheath tube 7 is fixedly coupled to the sheath joint 15, the sheath joint 15 is located inside the support body 17, and the support body 17 is provided with an axially extending guide.
  • the strip hole and the sheath joint 15 are fixed with a main body block 34 extending radially from the guide strip hole.
  • the sheath joint 15 is provided with the main body. The block 34 abuts against the mating flap 35.
  • the inner wall of the sliding handle 16 is provided with an inner tooth 14 , and the main body block 34 extends out of the guiding strip hole to cooperate with the inner tooth 14 , so that the sliding handle 16 can be sequentially driven through the main body block 34 and the sheath joint 15 as a linkage.
  • the sheath 7 is moved axially.
  • the release handle button 9 is fitted with a release button 10, and the release button 10 has a hook 10b of a unitary structure, and the hook 10b extends toward the side of the sliding handle 16.
  • a fixed position between the fixed handle 9 and the support body 17 is fixed between the button support body 12 and the button support body 12, such as a positioning post 10a on the release button 10, and two positioning posts.
  • a drive spring 11 is pressed against it to urge the hook 10b into position.
  • the rotating cover 13 on one side of the sliding handle 16 has an inner flange 13b, the hook 10b can be inserted into and engaged with the inner flange 13b, and the inner flange 13b can be engaged with the side of the hook 10b to be regarded as a circular positioning.
  • the slot which limits the axial position of the hook 10b, in turn allows the sliding handle 16 to rotate relative to the fixed handle 9.
  • the rotating cover 13 is provided with two concentrically arranged drag reducing rings 13a, which are brought into line contact by the surface contact between the drag reducing ring 13a and the fixed handle 9, thereby greatly reducing the The contact area reduces the resistance during relative motion and the release process is smoother and more accurate.
  • the support body 17 is integrally located on the outer side of the outer sheath tube, one end of which is connected to the fixed handle 9, and the other end is provided with a tail end fixing member 21 which fixes the inner liner 22 through the tail end. It is fixedly connected to the support body 17.
  • the pusher assembly is provided at the proximal end, that is, the tail portion of the support body 17, and includes a push rod fixing member 23 fixed coaxially with the support main body 17, and the push rod fixing member 23 is locked by the tail end fixing member inner liner 22, and the push rod supports the tube 18
  • One end is coaxially fixed to the push rod fixing member 23, and the other end is placed on the inner side of the outer sheath tube 7.
  • One end of the push rod 6 is coaxially fixed on the push rod joint 23 and placed inside the push rod support tube 18, and the other end is placed on the outer sheath.
  • Inside the tube 7, one end of the TPU hose 36 is connected to the three-way valve 20, and the other end is connected to the circumferential branch pipe of the push rod fixing member 23.
  • the pusher assembly located on the inner layer of the outer sheath tube and the outer layer of the outer sheath core tube serves as an axial support for the sheath portion of the conveyor; on the other hand, during the release of the stent, the sliding handle drives the outer sheath tube Withdrawing, the push rod assembly exerts a forward pushing reaction force on the axial direction of the bracket, which is favorable for the stent to release the sheath tube.
  • the fixing mechanism of the inner sheath core 4 includes a steel sleeve 26, an inner sheath core block 27 and a luer connector 32, which are connected to the inner sheath core 4 by one or more of screw locking, welding and bonding. Fixed by line.
  • the inner sheath core block 27 is sleeved on the outer side of the inner sheath core 4, and is fixed on the inner side of the tail end slide 31.
  • the steel sleeve 26 is disposed outside the inner sheath core 4 and fixed to one end of the inner sheath core block 27.
  • the Luer connector 32 intermediate through hole sleeve is disposed outside the inner sheath core and is fixed to the outside of the tail end slide 31.
  • a displacement adjusting mechanism of the outer sheath core tube 5 is also provided.
  • the displacement adjusting mechanism of the outer sheath core tube 5 includes a fixed anchor release knob block 29 disposed on the outer side of the tail release steel sleeve 30, and the nut 28 is placed at one end of the fixed release knob block 29, and is placed on the tail end to release the steel sleeve. On the outer side of the 30, the fixing release knob block 29 is fastened.
  • the distal end of the outer sheath core tube 5 is fixedly connected with the fixed anchor 2, the proximal end and the tail end release steel sleeve 30 are butted, and the outer sheath core support tube 19 is sleeved at the butt joint portion, and the outer sheath core support tube 19 is sleeved by bonding. Placed outside the outer sheath core tube 5.
  • the tubular tail end slide 31 is connected to the proximal end side of the tail end fixing member 21, the tail end releasing inner teeth 25 sets are disposed outside the tail end slide 31, and the tail end releasing inner tooth outer casing 24 is placed at the rear end to release the inner teeth 25 The end of the tail releasing inner casing 24 is attached to the end fixing member 21.
  • the inner edge of the end fixing member 21 is provided with a positioning protrusion 21a, and the tail end releasing inner tooth housing 24 is circumferentially positioned to ensure that it cannot rotate freely in the circumferential direction, and only the rear end is released from the rear end of the positioning protrusion 21a.
  • the tooth housing 24 can be rotated.
  • the inner end of the inner end release inner casing 24 is provided with a rotation linkage matched with the tail end release inner tooth 25, specifically a matching positioning rib 24a and a positioning rib groove structure, that is, The tail end releasing inner tooth outer casing 24 and the tail end releasing inner tooth 25 are allowed to slide axially, and can be circumferentially linked.
  • the end releasing inner tooth 25 is a hollow tube structure with a screw thread on the inner circumferential surface
  • the fixed release knob block 29 is an outer circumferential surface with a threaded cylindrical structure, the two are screwed together, and the tail end releases the inner tooth housing 24 to rotate.
  • the tail end release inner 25 can be driven to move axially along with the outer sheath core tube to adjust the forward and backward movement of the fixed anchor 2.
  • the procedure for treating aortic aneurysm or aortic dissection using the delivery delivery device of the present invention is as follows:
  • the stent delivery device is delivered to the aorta along the guide wire.
  • the stent delivery release device is moved to the vicinity of the lesion position, the left hand holds the fixed handle, and the right hand rotates the sliding handle 16 to slowly release the stent.
  • the bracket When the stent is released to a certain position, due to the proximal end of the stent At the position where the anchor 2 is restrained, when the bracket is not fully opened, the bracket is moved to the most suitable release position by moving the transport release device; after this operation is completed, the rotary handle is continued or the left hand is pressed by the button 10 and the right hand is simultaneously The sliding handle 16 is pulled back, the main body of the bracket is released, and then the proximal end of the bracket is released, the tail end is released, and the inner casing 24 is pulled back to release the rotation lock, and then rotated to retract the outer sheath core tube relative to the inner sheath core.
  • the proximal end of the stent When rotated to a certain distance, the proximal end of the stent disengages from the anchor 2 under the action of its own tension and automatically opens, completely disengages from the delivery release device, completes the release process, and finally withdraws the stent delivery device along the guide wire.

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

Abstract

一种主动脉支架的输送释放装置，包括鞘芯组件，外鞘管（7）以及用于控制鞘芯组件和外鞘管（7）轴向运动的控制手柄；该控制手柄包括支撑主体（17），固定手柄（9）以及活动套设在支撑主体（17）上的滑动把手（16），该外鞘管（7）与滑动把手（16）相连，该鞘芯组件与支撑主体（17）相连，该滑动把手（16）相对于支撑主体（17）轴向滑动以及周向旋转配合，依据滑动把手（16）的轴向位置，滑动把手（16）与固定手柄（9）之间具有沿轴向的抵靠状态以及分离状态；抵靠状态下滑动把手（16）与固定手柄（9）的之间以线接触的方式转动配合。该主动脉支架的输送释放装置的固定手柄（9）与滑动把手（16）之间采用线接触的方式，降低阻力，改善操作的顺滑性和手感，也避免了部件解体的风险。

Description

主动脉支架的输送释放装置 技术领域
本发明属于医疗器械领域，具体涉及一种治疗主动脉瘤和主动脉夹层的支架的输送释放装置。
背景技术
主动脉疾病主要包括主动脉真性动脉瘤、主动脉假性动脉瘤和主动脉夹层动脉瘤。其中主动脉真性动脉瘤不是真正的肿瘤，而是由于各种原因造成的主动脉局部或普遍扩张，主动脉直径大于正常直径50％以上的病理性改变。主动脉假性动脉瘤是动脉管壁被撕裂或穿破，血液自此破口流出而被主动脉邻近的组织包裹而形成血肿，多由于创伤所致。
主动脉夹层动脉瘤是由于主动脉内膜局部破损，高压血流冲入血管壁，造成中膜撕裂(中层的裂开通常是在中层内1/3和外2/3交界面)，使完整的主动脉壁结构一分为二，在夹层的内、外壁间的裂开间隙中形成一个夹层腔。为了与主动脉腔区别，夹层腔称为假腔，主动脉腔称为真腔。
主动脉真性动脉瘤和主动脉夹层动脉瘤都是极为凶险的疾病，发病后48小时内的死亡率大于50％，发病后两周内的死亡率大于85％，已经严重威胁人类健康。随着中国老龄化趋势的到来，其发病率将不断攀升。
一直以来所采用的主动脉疾病外科手术切除方法成功率低，而且在手术过程中容易因主动脉出血而危及患者的生命，因而近年来多采用新兴的微创、简捷的介入手术方法，通过在主动脉病变部位植入支架进行治疗。支架的植入方法是将支架压缩进输送释放装置后，然后通过股动脉的微创切口植入导丝引导，再沿着事先植入人体的导丝引导将支架经输送系统送到主动脉的病变位置，并在显影设备的辅助下输送至准确的病变部位后，将支架释放植入至病变部位。
专利文献CN102488576A公开了一种覆膜支架的输送释放装置，该输送系统通过调节转柄，带动螺纹连接件沿着导丝管轴向运动，此处调节转柄没有设 置控制开关，当操作者在使用输送器的过程中，极可能操作失误旋动此处的调节转柄，支架在还没有达到释放要求的情况，调节转柄控制的近端或者远端就已经释放出来，从而导致支架释放的位置不准确，最终会产生非常严重的后果，支架的释放失败；另一方面，其外导动套在向后端释放的过程中，会有一个向前拉外导动套的力，而外导动套与外壳固定套是面接触，外导动套转动时此处可能会产非常大的阻力，从而操作者也需要提供一个相对较大的扭力，才能顺利的把产品释放出来，这会导致释放支架的操作困难。
发明内容
本发明提供一种操作简单、释放可控、安全可靠的支架输送器释放装置。
一种主动脉支架的输送释放装置，包括鞘芯组件，外鞘管以及用于控制鞘芯组件和外鞘管轴向运动的控制手柄；所述控制手柄包括支撑主体，固定手柄以及活动套设在支撑主体上的滑动把手，所述外鞘管与滑动把手相连，所述鞘芯组件与支撑主体相连，所述滑动把手相对于支撑主体轴向滑动以及周向旋转配合，依据滑动把手的轴向位置，滑动把手与固定手柄之间具有沿轴向的抵靠状态以及分离状态；抵靠状态下滑动把手与固定把手的之间以线接触的方式转动配合。
现有技术中固定把手与滑动把手具有相抵配合的接触部位，两者相对转动时，接触面积过大会产生很大的转动阻力，固定把手与滑动把手一般采用分体结构，由于阻力过大很容易造成在受力的过程中被周向阻力旋开，造成在使用的过程中释放失败。
本发明固定把手与滑动把手以线接触的方式转动配合，可以大大降低阻力以及潜在的安全风险。
作为优选，在固定手柄上设有将滑动把手保持在抵靠状态的锁定机构。
锁定机构一方面限定滑动把手的轴向位置，另外还容许滑动把手转动。
作为优选，所述固定手柄上的锁定机构包括：
限制滑动把手轴向位置的卡勾；
与所述卡勾相连的释锁按钮；以及
驱使卡勾锁定滑动把手的驱动弹簧。本发明中为了在操作滑动把手时保持其轴向位置，固定手柄上设置了卡勾，现有技术中，滑动把手一般是通过旋转 并螺纹配合联动件的方式改变外鞘管位置，同时在需要快速调节时，直接沿轴向推拉滑动把手，本发明卡勾中重点在于限制滑动把手轴向位置，可根据需要容许滑动把手绕控制手柄轴线转动。
不仅如此，本发明中将释锁按钮和卡勾设置在固定手柄上，也可以避免在操作滑动手柄时误触发释锁按钮，进一步提高安全性。
本发明中近端指的是手术时，临近手术操作者的一端，即远离病灶的一侧。远端指的是手术时，远离手术者操作者的一端，即靠近病灶的一侧。
为了安装释锁按钮，并便于操作，作为优选，所述固定把手临近滑动把手的一侧为固定套在支撑主体外周的近端部，该近端部上设有安装孔，所述释锁按钮嵌装在该安装孔内。
释锁按钮的一部分暴露在安装孔区域，用以按压操作，释锁按钮上可以设置防滑纹等，本发明中释锁按钮的形状没有严格限制。
可选的，所述释锁按钮与卡勾之间固定连接、相抵配合或一体结构。
作为优选，所述滑动把手上设有与容纳卡勾的定位槽。
定位槽可容纳并将卡勾限制在其内，定位槽可以是与滑动把手一体结构形成也可以额外安装的部件提供，由于固定把手与滑动把手具有相抵配合的接触部位，定位槽的槽内可容纳就位后的卡勾，而一部分槽壁则阻挡卡勾退出，该部分槽壁优选在滑动把手远端侧的端面部位，端面部位设有开口使得卡勾经由开口伸入定位槽中，就该部分槽壁而言也可等价视为与卡勾相配合的阻挡部件，以保持卡扣就位后的轴向位置。
所述定位槽为绕控制手柄轴线分布的环形，与卡勾转动配合且轴向限位。
为了允许滑动把手转动，定位槽为环形且分布在滑动把手的内壁，在滑动把手转动时，不产生与卡勾之间的位置干涉，但始终保持轴向定位。
作为优选，所述驱动弹簧抵压在释锁按钮与支撑主体的外壁之间。
固定把手临近滑动把手的一侧固定套在支撑主体外周，驱动弹簧一端与释锁按钮相抵，另一端直接与支撑主体外周相抵，作为进一步的优选，所述释锁按钮与支撑主体相对的部位上，至少一者设有定位柱或定位孔，所述驱动弹簧的该端套在定位柱上或置入定位孔中。
例如，释锁按钮与支撑主体相对的部位上均设有定位柱，驱动弹簧为螺旋弹簧，两端分别套设在对应的定位柱上，可以防止受压时产生偏移或错位。
作为优选，所述固定把手固定在支撑主体上，且位于滑动把手的远端侧，所述固定把手临近滑动把手的一侧为固定套在支撑主体外周的近端部，滑动把手受卡勾锁定状态下，固定把手的近端部端面与滑动把手的轴向端面之间以线接触的方式转动配合。
作为优选，固定把手的近端部端面与滑动把手的轴向端面两者之间，至少一者带有绕滑动手柄旋转轴线布置的减摩凸环。
当固定把手与滑动把手均设有减阻凸环时，两者上的减阻凸环在径向上错位布置，以避免干涉。
作为优选，所述减阻凸环连续延伸或间断分布。
在周向上减阻凸环可以连续延伸或间断分布，间断分布时可以进一步减小接触面积，每段减阻凸环的周向两端一般采用圆角处理，避免产生局部尖端。
作为优选，所述减阻凸环的凸起顶部为弧形或凸棱。
线接触的形式可以采用凸环，凸环截面中，凸起部位的形状可以是尖角或弧形，通过尖角或弧顶部位都可实现线接触，作为优选采用弧形。
作为优选，所述减阻凸环为同心布置的至少两道。
作为优选，所述固定把手的近端套设有旋转盖，所述旋转盖的近端部端面与滑动把手的轴向端面之间以线接触的方式转动配合。
旋转盖与固定把手的近端部位可以是螺纹配合等方式，设置旋转盖即局部的分体结构使得部件更加便于拆装维护，线接触可采用之前所述的减阻凸环形式。
作为优选，所述滑动把手的远端套设有旋转盖，所述旋转盖的远端部端面与固定把手的轴向端面之间以线接触的方式转动配合。
旋转盖与滑动把手的远端部位可以是螺纹配合等方式，设置旋转盖即局部的分体结构使得部件更加便于拆装维护，线接触可采用之前所述的减阻凸环形式。
作为优选，所述旋转盖与滑动把手的远端侧螺纹配合，所述旋转盖的远端侧向内翻边，翻边部位的近端侧形成所述定位槽。
通过旋转盖的内翻边，来限制卡勾的轴向位置，也恰好可以实现与卡勾的转动配合。
为了实现滑动把手的转动以及螺纹方式驱动外鞘管，作为优选，所述支撑 主体为轴向贯通结构，其侧壁上设有沿轴向延伸的滑槽，所述外鞘管的近端侧伸入支撑主体内并固定有联动件，该联动件的一部分沿径向延伸出滑槽并与滑动把手的内壁螺纹配合。
滑动把手带有内螺纹，旋转时可以带动联动件即带动外鞘管轴向运动，沿轴向延伸的滑槽可以起到导向作用，并限定联动件的周向位置，防止联动件以及外鞘管转动。
作为优选，所述滑动把手为双层结构，其中内层与所述联动件螺纹配合。
采用双层结构，既可以满足强度要求又兼顾轻量化，就每一层而言可采用分体扣合的方式，便于组装，避免空间干涉。
作为优选，所述滑动把手在与联动件相应的位置上设有透明材质或镂空的观察窗。
作为优选，所述滑动把手上设有指示联动件相对位置的刻度。
通过观察窗结合刻度也可以在操作过程中识别联动件的位置，即得到外鞘管相对于鞘芯组件的位置，用以指导接入器械的释放状态。
作为优选，所述鞘芯组件包括内鞘芯和外鞘芯管，所述外鞘芯管滑动套设在内鞘芯外。
本发明鞘芯组件可采用现有技术，例如包括内外嵌套且可相对轴向滑动的内鞘芯和外鞘芯管，而外鞘管则处在外鞘芯管的外周，控制手柄上可以设置驱动外鞘芯管相对内鞘芯轴向滑动的外鞘芯调节机构。
本发明通过在固定把手上设置锁定机构，可在操作滑动把手时保持轴向的相对位置，避免不必要的分离以提高安全性，更进一步的在固定把手与滑动把手之间采用线接触的方式，降低阻力，改善操作的顺滑性和手感，也避免了部件解体的风险。
附图说明
图1为本发明输送释放装置的结构示意图；
图2为滑动把手的结构示意图；
图3为图1中输送释放装置的剖面图；
图4为图1中输送释放装置另一角度的剖面图；
图5为图3中A部分放大图；
图6为图5中B部分放大图；
图7为旋转盖的正视图；
图8为图5中C部分放大图；
图9为图5中D部分放大图。
具体实施方式
下面将结合附图和具体实施例对本发明进行详细说明。
结合图1，本发明的输送释放装置，包括鞘芯组件，外鞘管7以及用于控制鞘芯组件和外鞘管7相对轴向运动的控制手柄，鞘芯组件远端连接有圆锥形的TIP头(引导头)1。
控制手柄包括支撑主体17，安装支撑主体17上的固定把手9以及滑动且可以转动的套设在支撑主体17上的滑动把手16，其中外鞘管7与滑动把手相连，鞘芯组件与支撑主体17相连，固定把手9与滑动把手16之间设有相互配合以保持滑动把手16轴向位置的的锁定机构，在固定把手9上设有锁定机构的释锁按钮10。
结合图2，滑动把手16为双层结构的，可增加支撑强度，便于操作，外层带有观察窗16a以及刻度标志16b，内层为透明材料，在增加支撑强度的同时，仍能够通过内牙位置间接判断出支架释放出鞘管的长度。滑动把手16的远端侧螺纹配合有旋转盖13，该旋转盖13的远端部端面与固定把手9近端侧的轴向端面之间以线接触的方式转动配合。固定把手9的远端侧螺纹安装有固定把手旋盖。
支架固定组件(仅作临时标注，下同)
结合图5，TIP头1其中部沿轴向成型一中空管道；鞘芯组件包括内外嵌套且可相对轴向滑动的内鞘芯4和外鞘芯管5，内鞘芯4一端同TIP头1的尾端固定连接，且同所述的TIP头1的中空管通道相连通；内鞘芯4另一端延伸至控制手柄中，控制手柄相应的设置内鞘芯4的固定机构。
外鞘芯管5套置于内鞘芯4的外壁上，且可沿着内鞘芯的外壁滑动，外鞘管7套置于外鞘芯管5外侧，可沿外鞘芯外侧滑动，用于装载包覆支架。
在邻近TIP头1部位设置支架固定组件，包括固定锚2和倒钩3，固定锚2与外鞘芯管5远端固定连接，呈爪状结构，倒钩3与内鞘芯4点焊固定连接，再与TIP头1注塑在一起成型，支架固定组件可用于定位覆膜支架近端，其中固定锚2对支架近端起固定作用，倒钩3对支架起定位作用。
调节外鞘管以及锁定和减阻
图3结合图6，为了调节外鞘管7轴向位置，外鞘管7与鞘管接头15固定连接，鞘管接头15位于支撑主体17内部，支撑主体17上设有沿轴向延伸的导向条孔，鞘管接头15上固定有沿径向延伸出导向条孔的主体牙块34，为了限定主体牙块34在鞘管接头15上的轴向位置，鞘管接头15上设有与主体牙块34相抵定位配合的挡片35。
滑动把手16内壁设有内牙14，主体牙块34延伸出导向条孔与内牙14配合，使得滑动把手16旋转时可依次通过作为联动件的主体牙块34、鞘管接头15进而驱动外鞘管7作轴向运动。
为了更精确的控制外鞘管7的轴向运动，固定把手上9上嵌装有释锁按钮10，释锁按钮10带有一体结构的卡勾10b，卡勾10b朝滑动把手16一侧延伸，固定把手9上与支撑本体17之间固定有按钮支撑体12释锁按钮10与按钮支撑体12之间设有位置相对的定位柱，例如释锁按钮10上的定位柱10a，两定位柱之间抵压有驱动弹簧11，以驱使卡勾10b就位。
滑动把手16一侧的旋转盖13具有内翻边13b，卡勾10b可伸入并卡合在内翻边13b处，内翻边13b卡合卡勾10b的一侧即可视为环形的定位槽，即限制了卡勾10b的轴向位置，又允许滑动把手16相对于固定把手9旋转。
如图7所示，旋转盖13上设有两道同心布置的减阻凸环13a，通过减阻凸环13a与固定把手9之间由面接触变为线接触，大大减小两者间的接触面积，使其在相对运动时的阻力减小，释放过程更加平稳和准确。
推杆组件
结合图8，支撑主体17在整体上处在外鞘管的外侧，其一端同固定把手9相连接，另一端通过设有尾端固定件21，该尾端固定件21通过尾端固定内衬22与支撑主体17固定连接。
支撑主体17近端即尾部设有推杆组件，包括与支撑主体17同轴线固定的推杆固定件23，推杆固定件23通过尾端固定件内衬22锁紧，推杆支撑管18一端同轴固定于推杆固定件23上，另一端置于外鞘管7内侧推杆6一端同轴固定于推杆接头23上并置于推杆支撑管18内侧，另一端置于外鞘管7内侧，TPU软管36一端与三通阀20相连接，另一端与推杆固定件23圆周分支管连接。
一方面，位于外鞘管内层，外鞘芯管外层的推杆组件对输送器鞘管部分起到轴向支撑的作用；另一方面，在支架释放过程中，滑动把手带动外鞘管后撤，推杆组件对支架轴向起到前推的反作用力，有利于支架释放出鞘管。
内鞘芯固定机构
结合图8，内鞘芯4的固定机构包括钢套26、内鞘芯挡块27和鲁尔接头32，其通过螺丝锁、焊接和粘接中的一种或几种方式对内鞘芯4经行固定。其中内鞘芯挡块27套置于内鞘芯4外侧，固定于所述尾端滑道31内侧，钢套26置于内鞘芯4外侧，且固定于所述内鞘芯挡块27一端，鲁尔接头32中间通孔套置于内鞘芯外侧，固定于尾端滑道31外侧。
外鞘芯管位移调节机构
结合图8，控制手柄中为了驱使外鞘芯管5相对内鞘芯4运动，还设置了外鞘芯管5的位移调节机构。
外鞘芯管5的位移调节机构包括固定锚释放旋钮牙块29套置于尾端释放钢套30外侧，螺帽28置于固定释放旋钮牙块29一端，并套置于尾端释放钢套30外侧，对固定释放旋钮牙块29起到紧固作用。
外鞘芯管5的远端与固定锚2固定连接，近端与尾端释放钢套30对接，在对接部位套设有外鞘芯支撑管19，外鞘芯支撑管19通过粘接方式套置于外鞘芯管5外侧。
管状的尾端滑道31连接于尾端固定件21近端侧，尾端释放内牙25套置于尾端滑道31外侧，尾端释放内牙外壳24置于尾端释放内牙25外侧；尾端释放内牙外壳24一端连接在尾端固定件21上。
尾端固定件21内缘设有定位凸起21a，对尾端释放内牙外壳24起到圆周方向定位作用，保证其在圆周方向不能自由旋转，只有后撤脱离定位凸起21a尾端释放内牙外壳24才可以旋转。
为了驱使尾端释放内牙25转动，尾端释放内牙外壳24内侧设有与尾端释放内牙25相配合的旋转联动件，具体为相互配合的定位筋条24a和定位筋槽结构，即允许尾端释放内牙外壳24与尾端释放内牙25之间可轴向滑动，有可以周向联动。
尾端释放内牙25为一内侧圆周面带螺牙的中空管结构，固定释放旋钮牙块29为一外侧圆周面带有螺纹圆柱结构，两者螺纹连接，尾端释放内牙外壳24转动可驱使尾端释放内牙25连同外鞘芯管轴向移动从而来调节固定锚2的前后移动。
使用过程
采用本发明输送释放装置在治疗主动脉瘤或者主动脉夹层时的操作过程如下：
手术时，先从右侧股动脉穿刺，插入导丝，然后沿导丝将支架输送释放装置送入主动脉。在X光透视监视下，将支架输送释放装置移动到病变位置的附近，左手握住固定把手不动，右手旋转滑动把手16缓慢释放支架，当支架释放到一定位置时，由于支架的近端还处于束缚固定锚2的位置上，此时支架尚未完全打开，通过移动输送释放装置，将支架移动到最合适的释放位置；此操作完成后，继续旋转滑动把手或左手按下按钮10右手同时将滑动把手16往后拉，支架主体释放完成；紧接着释放支架近端，把尾端释放内牙外壳24往后拉脱开旋转锁定，然后旋转使得外鞘芯管相对于内鞘芯后撤，当旋转到一定的距离时，支架近端在自身张力的作用下脱离固定锚2的并自动张开，与输送释放装置完全脱离，完成释放过程，最后将支架输送装置沿导丝撤离出体外。
以上公开的仅为本发明的具体实施例，但是本发明并非局限于此，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。显然这些改动和变型均应属于本发明要求的保护范围保护内。此外，尽管本说明书中使用了一些特定的术语，但这些术语只是为了方便说明，并不对本发明构成任何特殊限制。

Claims (22)

  1. 一种主动脉支架的输送释放装置，包括鞘芯组件，外鞘管以及用于控制鞘芯组件和外鞘管轴向运动的控制手柄；所述控制手柄包括支撑主体，固定手柄以及活动套设在支撑主体上的滑动把手，所述外鞘管与滑动把手相连，所述鞘芯组件与支撑主体相连，其特征在于，所述滑动把手相对于支撑主体轴向滑动以及周向旋转配合，依据滑动把手的轴向位置，滑动把手与固定手柄之间具有沿轴向的抵靠状态以及分离状态；抵靠状态下滑动把手与固定把手的之间以线接触的方式转动配合。
  2. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，在固定手柄上设有将滑动把手保持在抵靠状态的锁定机构。
  3. 如权利要求2所述的主动脉支架的输送释放装置，其特征在于，所述固定手柄上的锁定机构包括：
    限制滑动把手轴向位置的卡勾；
    与所述卡勾相连的释锁按钮；以及
    驱使卡勾锁定滑动把手的驱动弹簧。
  4. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，所述固定把手临近滑动把手的一侧为固定套在支撑主体外周的近端部，该近端部上设有安装孔，所述释锁按钮嵌装在该安装孔内。
  5. 如权利要求4所述的主动脉支架的输送释放装置，其特征在于，所述释锁按钮与卡勾之间固定连接、相抵配合或一体结构。
  6. 如权利要求5所述的主动脉支架的输送释放装置，其特征在于，所述滑动把手上设有与容纳卡勾的定位槽。
  7. 如权利要求6所述的主动脉支架的输送释放装置，其特征在于，所述定位槽为绕控制手柄轴线分布的环形，与卡勾转动配合且轴向限位。
  8. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，所述驱动弹簧抵押在释锁按钮与支撑主体的外壁之间。
  9. 如权利要求8所述的主动脉支架的输送释放装置，其特征在于，所述释锁按钮与支撑主体相对的部位上，至少一者设有定位柱或定位孔，所述驱动弹簧的该端套在定位柱上或置入定位孔中。
  10. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，所述固定把手固定在支撑主体上，且位于滑动把手的远端侧，所述固定把手临近滑动把手的一侧为固定套在支撑主体外周的近端部，抵靠状态下，固定把手的近端部端面与滑动把手的轴向端面之间以线接触的方式转动配合。
  11. 如权利要求10所述的主动脉支架的输送释放装置，其特征在于，固定把手的近端部端面与滑动把手的轴向端面两者之间，至少一者带有绕滑动手柄旋转轴线布置的减阻凸环。
  12. 如权利要求11所述的主动脉支架的输送释放装置，其特征在于，所述减阻凸环连续延伸或间断分布。
  13. 如权利要求12所述的主动脉支架的输送释放装置，其特征在于，所述减阻凸环的凸起顶部为弧形或凸棱。
  14. 如权利要求11所述的主动脉支架的输送释放装置，其特征在于，所述减阻凸环为同心布置的至少两道。
  15. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，所述固定把手的近端套设有旋转盖，所述旋转盖的近端部端面与滑动把手的轴向端面之间以线接触的方式转动配合。
  16. 如权利要求6所述的主动脉支架的输送释放装置，其特征在于，所述滑动把手的远端套设有旋转盖，所述旋转盖的远端部端面与固定把手的轴向端面之间以线接触的方式转动配合。
  17. 如权利要求16所述的主动脉支架的输送释放装置，其特征在于，所述旋转盖与滑动把手的远端侧螺纹配合，所述旋转盖的远端侧向内翻边，翻边部位的近端侧形成所述定位槽。
  18. 如权利要求1～17任一项所述的主动脉支架的输送释放装置，其 特征在于，所述支撑主体为轴向贯通结构，其侧壁上设有沿轴向延伸的滑槽，所述外鞘管的近端侧伸入支撑主体内并固定有联动件，该联动件的一部分沿径向延伸出滑槽并与滑动把手的内壁螺纹配合。
  19. 如权利要求18所述的主动脉支架的输送释放装置，其特征在于，所述滑动把手为双层结构，其中内层与所述联动件螺纹配合。
  20. 如权利要求18所述的主动脉支架的输送释放装置，其特征在于，所述滑动把手在与联动件相应的位置上设有透明材质或镂空的观察窗。
  21. 如权利要求18所述的主动脉支架的输送释放装置，其特征在于，所述滑动把手上设有指示联动件相对位置的刻度。
  22. 如权利要求1所述的主动脉支架的输送释放装置，其特征在于，所述鞘芯组件包括内鞘芯和外鞘芯管，所述外鞘芯管滑动套设在内鞘芯外。
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