CN109602522B - Self-expanding braided stent and conveying device thereof - Google Patents
Self-expanding braided stent and conveying device thereof Download PDFInfo
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- CN109602522B CN109602522B CN201811488344.6A CN201811488344A CN109602522B CN 109602522 B CN109602522 B CN 109602522B CN 201811488344 A CN201811488344 A CN 201811488344A CN 109602522 B CN109602522 B CN 109602522B
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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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
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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Abstract
The invention relates to a self-expansion type braided stent and a conveying device thereof. Specifically, the invention provides a self-expanding braided stent, wherein the length of the stent before release is 1.82-2.22 times of the length of the stent after release; the axial short shrinkage rate of the bracket is 45-55%; the weaving angle of the bracket is 90-140 degrees. The invention also provides a conveying device for conveying the bracket. The self-expansion type braided stent avoids the stent from being elongated and released from the design angle, and the stent propelling tube moves towards the far end in the releasing process, so that the axial shortening amount of the released stent is compensated, the patency rate of the blood vessel of the implanted braided stent is improved, and the treatment effect of the stent is improved.
Description
The application is a divisional application of an invention application with the application date of 2017, 12 and 07, the application number of 201711285758.4 and the name of 'self-expanding braided stent and a delivery device thereof'.
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a self-expansion type braided stent and a conveying device thereof.
Background
Vascular diseases, called vascular diseases in traditional Chinese medicine, have obviously increased incidence in recent years, and are commonly seen as arterial stenotic lesions, arteriovenous thrombosis, aneurysms and the like. Peripheral arterial stenosis occlusive lesions, which are commonly seen in atherosclerosis, diabetes, aortic inflammation and the like, are mainly characterized by skin temperature reduction, muscle atrophy, pulse failure or pulse attenuation, intermittent claudication, distal limb necrosis even amputation in severe cases and life danger in severe cases; venous thrombosis disease can cause blood stasis and swelling of affected limbs, and has risk of fatal pulmonary artery embolism; the aneurysm diseases have the risk of rupture, massive hemorrhage and death of the aneurysm body at any time. The vascular diseases have high disability rate and certain fatality rate, the medical treatment effect is very little, and the surgical treatment is an invasive treatment method and has limited effect.
According to the consensus statement of endovascular intervention in peripheral arterial disease issued by the american society for cardiovascular imaging and intervention (SCAI) 2014, almost all of the main-iliac Peripheral Arterial Disease (PAD) can be treated with endovascular intervention, but there is no evidence to show that one stent is superior to the other type. For main-iliac artery PAD graded as grade A, B, C for TASC (TransAtlantic Inter-society consensus group) endovascular intervention was superior to endarterectomy, evidence indicating that the former was more advantageous in reducing patient mortality (endarterectomy hospitalized mortality rate 2.7%). Open surgical treatment is the last choice for this type of disease due to surgical risk issues; the success rate of intravascular interventional therapy exceeds 90 percent, the mortality rate is low, and the intravascular interventional therapy is a suitable treatment strategy for patients who cannot effectively control symptoms by changing life style and exercise.
The classification standards of the vascular stent are various, and the stent release mode can be divided into a balloon expansion type stent and a self-expansion type stent, and the stent function can be divided into a bare stent, a drug coating stent and a covered stent. The stent structure is divided into a tubular stent, a ring stent, a winding stent and a braided stent. Stent materials include stainless steel, nickel titanium and cobalt chromium alloy stents.
Sacculus expansion support itself inelasticity, its design is that the support is adorned in advance on the sacculus, carries the support to vascular pathological change department through sacculus pipe, and the sacculus expands to rely on the vascular wall to retract the power to attach in the vascular wall after certain diameter, does not produce the tension of continuously expanding to the vascular wall. The maximum advantage is that the release positioning is accurate, and the device is suitable for the open lesions, such as vertebral artery open lesions and renal artery open lesions. In addition, the stent has the characteristics of unobvious axial shortening phenomenon after release, stronger radial supporting force than that of a self-expanding stent and the like. However, the balloon expandable stent is poor in elasticity, is easy to collapse and occlude after being pressed, is poor in flexibility, and is not suitable for parts which are easy to be pressed or move joints, such as extracranial carotid artery, femoral popliteal artery and the like. The peripheral blood vessel is suitable for the limited short-segment narrow occlusion lesion (<4cm) in a straight and non-movable joint area.
Self-expanding stent is through compressing the support in carrying the sheath and carrying vascular pathological change department, and the sheath is withdrawn outward and is released the support, thereby relies on obtaining the equilibrium relation between the elasticity restriction of support self expansion tension and vascular wall. But self-expanding stents have drawbacks including: when the stent is released, the phenomena of forward jumping and axial shortening exist, and the precise positioning and releasing are difficult; the axial length of the stent released from the sheath tube is obviously reduced, the length of the stent is obviously shortened in the axial direction, the stent can shift to the near end along with the release in the release process, the position of a conveying system needs to be manually adjusted by an operator in the operation process, so that the operator cannot accurately control the positioning of the stent in the operation process, the positioning of the far end and the near end of the stent is difficult, and the release position is not ideal; the flexibility and the bending and twisting resistance of the stent can not completely adapt to the complex stress of the blood vessel caused by the long-term continuous mechanical motion of the human body, and the stent is easy to generate stress fatigue after being implanted for a long time to generate stent fracture, so that the blood vessel has the symptom of restenosis. The long-term patency rate of the blood vessel is reduced. Therefore, the stents are always poor in treating the vascular diseases.
Therefore, there is a need in the art to develop an intravascular stent and a delivery device thereof, wherein the stent has good performance and the delivery device can accurately and rapidly release the stent into a target lesion.
Disclosure of Invention
The invention aims to provide a self-expansion type braided stent and a conveying device thereof, which can realize accurate release in a blood vessel, avoid excessive elongation/compression release, improve the patency rate of the blood vessel, have accurate positioning and convenient operation.
In a first aspect of the present invention, there is provided a self-expanding braided stent having a length before release that is 1.82 to 2.22 times the length after release of the stent; the axial short shrinkage rate of the bracket is 45-55%; the weaving angle of the bracket is 90-140 degrees.
In another preferred embodiment, the length of the stent before release is 1.85 to 2.1 times, preferably 1.9 to 1.95 times the length of the stent after release.
In another preferred embodiment, the stent has an axial foreshortening of 46-52%, preferably 47-49%.
In another preferred embodiment, the braiding angle of the stent is 110-.
In another preferred embodiment, the outer diameter of the stent after loading compression is 1.6-2.13 mm.
In another preferred embodiment, the outer diameter of the stent after loading compression is 1.7-2.0mm, preferably 1.75-1.9 mm.
In another preferred embodiment, the wire diameter of the stent is 0.1-0.2 mm.
In another preferred embodiment, the diameter of the stent is 4-8 mm.
In another preferred embodiment, the diameter of the stent is 4.5-7.0 mm.
In another preferred example, the number of weaving heads of the stent is 4-8.
A second aspect of the present invention provides a stent delivery device, the delivery device comprising: (a) the self-expanding braided stent provided by the first aspect of the invention; (b) and a conveying component.
In another preferred embodiment, the conveying component comprises an inner tube, a stent propelling tube, a stent binding tube, a handle shell, a driving device joint, a luer joint, a stent binding tube joint, a stent propelling tube driving device and a transmission device.
In another preferred embodiment, the stent constraining tube has an outer diameter of 2.0-2.33 mm.
In another preferred embodiment, the inner diameter of the stent restraining tube is 1.6-2.13 mm.
In another preferred embodiment, the stent pusher tube driving device includes a rigid pusher tube connected to the stent pusher tube, and a driving handle connected to the rigid pusher tube, a distal end of the rigid pusher tube is connected to a proximal end of the stent pusher tube, and the driving device joint is fixed to an outer surface of the rigid pusher tube.
In another preferred example, the distal end of the rigid push tube is placed in the stent restraining tube.
In another preferred example, the driving handle connected with the rigid pushing tube is provided with a scale display for displaying the distance of the distal movement of the rigid pushing tube.
In another preferred example, the distance between the proximal end of the rigid push tube and the proximal end of the stent constraining tube is 2-2.5 times the nominal length of the loaded self-expanding braided stent.
In another preferred embodiment, the inner tube is provided with a development ring mark for indicating the proximal and distal positions after the stent is released.
In another preferred embodiment, the drive means joint and the bracket restraint pipe joint move towards each other along the rigid slide rod.
In another preferred embodiment, the transmission device consists of a conveyor belt and a fixed pulley.
In another preferred example, the rack restraining pipe is used for restraining a loaded rack, the transmission device is composed of a conveyor belt and a fixed pulley, the conveyor belt penetrates through the fixed pulley, one end of the conveyor belt is connected with the outer surface of the rack restraining pipe through a rack restraining pipe joint, the rack restraining pipe joint is fixed on the outer surface of the near end of the rack restraining pipe, the near end of the rack pushing pipe is connected with the rack pushing pipe driving device, and the other end of the conveyor belt is connected with the rack pushing pipe driving device through the driving device joint.
In another preferred embodiment, the transmission device is composed of a gear and a rack.
In another preferred example, the stent restraining tube is used for restraining a loaded stent, the transmission device is composed of two racks S1 and S2 moving in opposite directions and a gear S3, the rack S2 is connected with the stent restraining tube through a conveyor belt and a stent restraining tube joint, the rack S1 is connected with the stent pushing tube through a rigid pushing tube, the gear S3 moves clockwise to drive the racks S1 and S2 to move in opposite directions, the stent restraining tube joint is fixed on the outer surface of the proximal end of the stent restraining tube, and the proximal end of the stent pushing tube is connected with the stent pushing tube driving device.
In another preferred embodiment, the support push pipe driving device used in cooperation with the transmission device formed by the gear and the rack is driven by a gun-type handle, and the gun-type handle, the gear and the rack form a separate handle.
In another preferred embodiment, the stent restraining tube is connected with a rigid connecting piece of the gun-type handle through a buckle, and the rigid connecting piece drives the stent restraining tube to move towards the distal end when moving towards the distal end; the bracket propelling tube is also connected with the rigid connecting piece of the gun type handle through the buckle, when the rigid connecting piece moves towards the near end, the bracket propelling tube is driven to move towards the near end, and the rigid connecting piece realizes opposite movement through the gun type handle, so that the bracket restraining tube and the bracket propelling tube (2) are driven to keep opposite movement.
In another preferred embodiment, the buckle is composed of a positioning chuck and a positioning card, the positioning chuck is fixed on the surface of the bracket bounding tube, and the positioning card is fixed on the hard connecting piece.
In another preferred example, the buckle is composed of a positioning chuck and a positioning card, the positioning chuck is fixed on the surface of the bracket pushing pipe), and the positioning card) is fixed on the hard connecting piece.
In another preferred embodiment, the rigid connector is connected with the rack S2, and the rigid connector is connected with the rack S1. The handle drive gear S3 makes a clockwise motion.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.
Drawings
FIG. 1 is a schematic view of the weave angles in one embodiment of the present invention.
Figure 2 is an elevation view of a braided stent of nominal length and loaded in accordance with one embodiment of the present invention.
Fig. 3 is a schematic view of a fixed pulley conveyor according to an embodiment of the present invention.
FIG. 4 is a schematic view of a rack and pinion conveyor according to one embodiment of the present invention.
Fig. 5 is a cross-sectional view of a pistol grip of one embodiment of the present invention.
FIG. 6 is a schematic view of a snap in one embodiment of the present invention.
FIG. 7 shows the 1-year patency rate of the blood vessels of different release effects of the braided stent of a comparative example of the present invention
Wherein, the number A1 represents the braiding angle, L represents the nominal length of the stent, D represents the nominal diameter of the stent, and D1 represents the loaded diameter of the stent; l1 represents the stent loaded length. 1 represents an inner tube, 2 represents a stent pusher tube, 3 represents a stent binder tube, 4 represents a handle housing, 5 represents a driver fitting, 6 represents a luer fitting, 7 represents a stent binder fitting, 8 represents a stent pusher tube driver, 9 represents a conveyor belt, 10 represents a fixed pulley, 11 and 12 represent rigid connectors, 13 and 14 represent gun-type handles, 15 represents a snap, 151 represents a positioning card, and 152 represents a positioning chuck.
Detailed Description
The invention develops a self-expanding braided stent and a conveying device thereof for the first time through extensive and intensive research, wherein the length of the stent before release is 1.82-2.22 times of the length of the stent after release; the axial short shrinkage rate of the bracket is 45-55%; the weaving angle of the bracket is 90-140 degrees. The self-expansion type braided stent and the conveying device thereof, which are developed by the invention, can realize accurate release of the stent, avoid the elongated release of the stent, obviously improve the patency rate of blood vessels after the stent is implanted, and have the advantages of accurate positioning and convenient operation. Based on the above findings, the inventors have completed the present invention.
Term(s) for
As used herein, the term "nominal length" refers to the length of the stent after release, i.e., the axial length of the stent after detachment from the stent constraining tube.
As used herein, the term "diameter of the stent" refers to the outer diameter of the stent.
As used herein, the term "wire diameter of a stent" refers to the diameter of a stent wire.
As used herein, the term "stent loaded compressed outer diameter" refers to the outer diameter of a stent that is loaded compressed inside a delivery system.
As used herein, the term "pre-stent-release length" refers to the axial length of the stent loaded within the stent constraining tube.
As used herein, the term "post-stent-release length" refers to the axial length of the stent after release from the interior of the delivery system.
As used herein, the term "axial foreshortening" refers to the change in length of the stent as a percentage of the length of the stent before release and after release.
Self-expanding braided stent
The invention provides a self-expanding braided stent, wherein the length of the stent before release is 1.82-2.22 times of the length of the stent after release; the axial short shrinkage rate of the bracket is 45-55%; the weaving angle of the bracket is 90-140.
The axial foreshortening ratio is referred to as the percentage change in the length of the stent before release and the length of the stent after release.
In another preferred embodiment, the length of the stent before release is 1.85 to 2.1 times, preferably 1.9 to 1.95 times the length of the stent after release.
In another preferred embodiment, the stent has an axial foreshortening of 46-52%, preferably 47-49%.
In another preferred embodiment, the braiding angle of the stent is 110-.
The braiding angle a1 is defined as the angle a1 formed by crossing stent filaments in the axial direction when the stent is at a nominal diameter D, which is the diameter of the stent at its nominal length, i.e., the diameter of the stent after release, as shown in fig. 1.
Through repeated experiments and researches of the inventor, the weaving angle A1 of the self-expanding type woven stent is 90-140 degrees, the stent has better radial supporting force and flexibility and lower axial shrinkage, the larger the weaving angle A1 is, the better the supporting force and the flexibility are, but the larger the axial shrinkage of the stent is, the more difficult the delivery is. Further, through a plurality of experimental researches, the inventor finds that when the weaving angle A1 of the stent is 110-135 degrees, the supporting force, the flexibility and the axial shortening rate of the stent reach a perfect balance. Furthermore, the weaving angle A1 of the stent is at 115-125 ℃, so that the stent has good supporting force and flexibility and appropriate axial shrinkage. The axial shrinkage of the stent is 47-49%. The length of the stent before release is 1.90-1.95 times of the length of the stent after release. As shown in fig. 2.
In the present invention, the length of the stent before release is 1.82 to 2.22 times, preferably 1.85 to 2.1 times, more preferably 1.9 to 1.95 times the length of the stent after release, so that the stent can be prevented from being released by axial elongation. The self-expanding braided stent of the invention is released by slight axial compression, overcoming the problem that the stent is slightly elongated and lengthened in the axial direction because an operator may slightly move the delivery system to the proximal end in the process of releasing the stent in the operation. The existing clinical trial researches find that the patency rate of the diseased blood vessel is obviously reduced after the stent is axially elongated. The self-expanding braided stent of the present invention is therefore able to compensate for the possible slight elongated release of the stent during surgery.
In a preferred embodiment of the present invention, the inventors respectively and preferably design the characteristics of the stent of the self-expandable braided stent, such as the outer diameter after loading and compressing, the wire diameter of the stent, the diameter of the stent, and the number of braided heads, and specifically as follows:
in a preferred embodiment, the compressed outer diameter of the loaded vascular stent has a greater influence on the passability of the stent and the delivery device. The smaller the outer diameter of the stent after loading compression, the smaller the diameter of the stent-constraining tube used to load the stent can be, the better the stent and delivery system will pass through the vessel. But the outer diameter of the blood vessel stent after being loaded and compressed is smaller, so that the difficulty of releasing the stent from the stent restraining tube is increased, the releasing force of pushing the stent from the stent restraining tube is obviously increased, the outer diameter of the stent after being reloaded and compressed is selected to be 1.6-2.13mm, preferably 1.7-2.0mm, and more preferably 1.75-1.9 mm.
In a preferred embodiment, the wire diameter of the stent has a significant influence on the supporting force of the stent, the supporting force of the stent is increased almost in a square order when the wire diameter of the stent is larger, but the larger wire diameter of the stent also influences the effect of the blood vessel on the endothelial hyperplasia coating of the stent. According to the invention, through experimental design and optimization research, the wire diameter of the stent is 0.1-0.2mm, so that the stent has good supporting performance and can complete endothelialization in a short time.
In a preferred embodiment, the diameter of the stent is 4-8 mm. In the embodiment of the invention for treating the stenosis of the peripheral lower limbs, the self-expanding braided stent with the diameter of 4-8mm has good supporting performance for a blood vessel, can keep effective support for a stenosis patch, has low radial outward force, avoids the vascular endothelium from being excessively proliferated due to stimulation of the stent on vascular tissues, has good flexibility and bending resistance in the blood vessel, can adapt to the distortion form and the complex stress environment of the blood vessel, ensures that the supporting force can be rapidly transmitted and released, and has low axial shrinkage. In another preferred embodiment of the present invention, the diameter of the stent is 4.5-7.0 mm.
In another preferred example, the number of the weaving heads of the stent is defined as the number of meshes in the circumferential direction of the stent, and the number of the weaving heads of the woven stent determines the size of the mesh area of the stent under the condition that the diameter of the stent is determined, thereby influencing the metal coverage area of the stent in a blood vessel. The more the weaving heads are, the smaller the mesh area of the stent is, the more the metal covering area of the stent in the blood vessel can be increased, which can seriously affect the endothelialization process of the stent covered by the endothelial cells, and through our experimental design and optimization, the weaving heads of the stent are 4-8. The stent has a more suitable mesh area and the metal coverage area of the stent is between 16-27%.
Self-expanding braided stent delivery device
The invention provides a conveying device, which comprises:
(a) a self-expanding braided stent;
(b) and a conveying component.
In a preferred embodiment of the invention, the conveying component comprises an inner tube 1, a stent pushing tube 2, a stent binding tube 3, a handle shell 4, a driving device joint 5, a luer joint 6, a stent binding tube joint 7, a stent pushing tube driving device 8 and a transmission device;
it has been experimentally investigated that the stent binder tube 3 preferably used for loading compressed stents has an outer diameter of 6-7F, i.e. the outer diameter of the stent binder tube is between 2.0-2.33 mm.
In another preferred embodiment, the inner diameter of the stent restraining tube 3 is 1.6-2.13 mm. The inventor finds that the influence of the outer diameter of the stent after being loaded and compressed on the axial shortening rate of the stent is small in a certain range, and the slight change of the knitting angle has a large influence on the outer diameter of the stent after being loaded and compressed but has a small influence on the axial shortening rate of the stent because the knitting angle of the stent in the stent binding tube after being loaded and compressed is small. Therefore, the stent loading has approximate axial shrinkage within the stent constraining tube with the inner diameter of 1.6-2.13 mm.
In another preferred embodiment, the stent pusher tube driving device 8 includes a rigid pusher tube connected to the stent pusher tube 2, and a driving handle connected to the rigid pusher tube, the distal end of the rigid pusher tube is connected to the proximal end of the stent pusher tube 2, and the driving device joint 5 is fixed on the outer surface of the rigid pusher tube. Preferably, the distal end of the rigid push tube is arranged in the stent restraining tube 3. In another preferred embodiment, the distance between the proximal end of the rigid push tube and the proximal end of the stent constraining tube 3 is 2-2.5 times the nominal length of the loaded self-expanding braided stent. When the stent is released, the distal end of the rigid push tube moves to the distal end and enters the stent binding tube 3, and the proximal end of the stent binding tube 3 moves to the proximal end, so that the stent is released at the position of a target lesion blood vessel in an in-situ compensation manner.
In another preferred example, the driving handle connected with the rigid pushing tube is provided with a scale display for displaying the distance of the distal movement of the rigid pushing tube. The operator can observe the released length of the bracket conveniently.
In another preferred embodiment, the inner tube 1 is provided with a developing ring mark for indicating the proximal and distal positions after the stent is released.
In another preferred embodiment, the drive means joint 5 and the bracket binding pipe joint 7 move towards each other along a rigid sliding rod.
In another preferred embodiment, the transmission device is composed of a conveyor belt 9 and a fixed pulley 10.
In another preferred embodiment, the stent restraining tube 3 is used for restraining a loaded stent, the transmission device is composed of a conveyor belt 9 and the fixed pulley 10, the conveyor belt 9 passes through the fixed pulley 10, one end of the conveyor belt 9 is connected with the outer surface of the stent restraining tube 3 through the stent restraining tube joint 7, the stent restraining tube joint 7 is fixed on the outer surface of the proximal end of the stent restraining tube 3, the proximal end of the stent pushing tube 2 is connected with the stent pushing tube driving device 8, and the other end of the conveyor belt 9 is connected with the stent pushing tube driving device 8 through the driving device joint 5. As shown in fig. 3. In a preferred embodiment of the present invention, the conveyor belt 9 passes through the fixed pulley 10 and is in a tension state, the stent pushing tube driving device 8 drives the stent pushing tube 2 to move towards the distal end, and since the stent restraining tube 3 is connected with the stent pushing tube 2 through the conveyor belt 9 and the fixed pulley, the stent pushing tube driving device 8 also synchronously drives the stent restraining tube 3 to move towards the proximal end in a facing manner, that is, the stent restraining tube 3 and the stent pushing tube 2 keep the same moving speed and move in a facing manner.
In another preferred embodiment, the transmission device comprises a gear and a rack, except that the transmission device which combines a conveyor belt and a fixed pulley is adopted to realize the opposite movement. As shown in fig. 4.
In another preferred embodiment, the stent restraining tube 3 is used for restraining a loaded stent, the transmission device is composed of two racks S1, S2 and a gear S3 which move in opposite directions, the rack S2 is connected with the stent restraining tube 3 through a conveyor belt and the stent restraining tube joint 7, the rack S1 is connected with the stent pushing tube 2 through a rigid pushing tube, the gear S3 moves clockwise to drive the racks S1 and S2 to move in opposite directions, the stent restraining tube joint 7 is fixed on the outer surface of the proximal end of the stent restraining tube 3, and the proximal end of the stent pushing tube 2 is connected with the stent pushing tube driving device 8.
In another preferred embodiment, the support push tube driving device 8 used in cooperation with the transmission device formed by the gear and the rack is driven by a gun-type handle, and the gun-type handle, the gear and the rack form a separate handle. The separated handle and the bracket conveying device can be assembled and used in the operation process without preoperative packaging.
In another preferred embodiment, the stent restraining tube 3 is connected with the rigid connector 11 of the gun-type handle through a buckle 15, and when the rigid connector 11 moves towards the distal end, the rigid connector drives the stent restraining tube 3 to move towards the distal end; the stent pushing tube 2 is also connected with the rigid connecting piece 12 of the gun type handle through the buckle 15, when the rigid connecting piece 12 moves towards the proximal end, the rigid connecting piece 12 drives the stent pushing tube 2 to move towards the proximal end, and the rigid connecting pieces 11 and 12 realize opposite movement through the gun type handles 13 and 14, so that the stent binding tube 3 and the stent pushing tube 2 are driven to keep opposite movement. As shown in fig. 5.
Further, the handle and the stent restraining tube and the stent pushing tube can be assembled for use before operation. In another preferred embodiment, as shown in fig. 6, the snap 15 is composed of a positioning chuck 152 and a positioning card 151, the positioning chuck 152 is fixed on the surface of the stent restraining tube 3, and the positioning card 151 is fixed on the hard connecting member 11. Before operation, the positioning clamping piece 151 is clamped in the inter-ring gap of the positioning clamping disc 152, so that the handle drives the rigid connecting piece 11 to drive the stent restraining tube 3 to move.
In another preferred embodiment, the snap 15 is composed of a positioning chuck 152 and a positioning card 151, the positioning chuck 152 is fixed on the surface of the support pushing pipe 2, and the positioning card 151 is fixed on the hard connecting member 12. Before operation, the positioning clamping piece 151 is clamped in the inter-ring gap of the positioning clamping disc 152, so that the handle drives the hard connecting piece 12 to drive the bracket pushing tube 2 to move.
In another preferred embodiment, the rigid connector 11 is connected to the rack S2, and the rigid connector 12 is connected to the rack S1. The handles 13, 14 drive the gear S3 in a clockwise motion.
The main technical advantages of the invention
(1) The invention realizes the accurate release of the stent, avoids the excessive elongation/compression release of the stent in the surgical implantation process and obviously improves the patency rate of the blood vessel after the stent is implanted.
(2) In addition, the technical scheme effectively solves the problem that the proximal end of the stent is not clearly positioned, which is complained by current vascular surgeons, in the reciprocating design in the prior art, the stent is pushed out section by section, the stretching or the compression of the stent depends on the on-site instant operation of the surgeon, and the surgeon cannot determine the release position of the proximal end of the stent in the operation. If the proximal end of the stent is closer to the bifurcation of the blood vessel, the bifurcated blood vessel is likely to be blocked, and the current common practice of doctors is to control the proximal end of the released stent to have a certain distance from the bifurcated blood vessel as a buffer after the selected stent is released. But the amount of the buffer distance cannot be controlled. If the distance from the stent to the bifurcated vessel is too large after the stent is released and the lesion cannot be completely covered, a short stent needs to be additionally placed at the near end. Resulting in an increase in the cost of treatment for the patient. The invention effectively solves the problem. In the invention, the length of the released stent is nearly half of the length of the released stent, the release position of the proximal end of the stent can be observed and judged before the stent is released, the release position of the proximal end of the stent is usually marked by arranging the developing mark on the surface of the inner tube, and in the invention, the inner tube is kept fixed in position in the process of releasing the stent, which is beneficial for a doctor to judge the proximal end position of the released stent.
(3) The pushing release bracket is adopted, so that the complicated operation of reciprocating release is avoided, the bracket release process is consistent with the release process of the existing common nickel-titanium cutting bracket in the operation, and an operator does not need to learn the release operation again; the reciprocating release in the prior art requires the operator to control the amount of the stent release compensation by himself, requires a high level of release skill, and thus has a long learning curve.
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers.
Example 1
In this example, the stent was woven with 0.15mm ni-ti wires, 4.5mm in diameter, 4 stent weaving heads, 120 degrees in weaving angle a1, the stent was loaded and compressed in the stent constraining tube, and the stent released from the stent constraining tube had an axial shrinkage of 47.6% at an inner diameter of about 1.75 mm. In this embodiment, the fixed pulley transmission device is used to control the support binding tube 3 and the support pushing tube 2 to move in opposite directions. The transmission device comprises a conveying belt 9 and a fixed pulley 10, one end of the conveying belt is connected with the outer surface of the support binding pipe 3 through a support binding pipe joint 7, the support binding pipe joint 7 is fixed on the outer surface of the near end of the support binding pipe 3, the near end of the support pushing pipe 2 is connected with a driving device 8, and the other end of the conveying belt 9 is connected with the support pushing pipe driving device 8 through a driving device joint 5. The conveyor belt 9 passes over a fixed pulley 10 and is under tension. The driving device 8 drives the support pushing pipe 2 to move towards the far end, and the support binding pipe 3 is connected with the support pushing pipe 2 through the driving belt 9 and the fixed pulley, so that the driving device 8 synchronously drives the support binding pipe 3 to move towards the near end in the opposite direction. Namely, the stent restraining tube 3 and the stent propelling tube 2 move towards each other at the same moving speed. Meanwhile, the driving device 8 comprises a rigid pushing pipe connected with the support pushing pipe and a driving handle connected with the rigid pushing pipe. The far end of the hard pushing pipe is connected with the near end of the bracket pushing pipe 2, and the driving device joint 5 is fixed on the outer surface of the hard pushing pipe. Preferably the distal end of the rigid push tube is placed in the stent constraining tube 3. The distance between the proximal end of the rigid pusher tube and the proximal end of the stent constraining tube 3 should exceed 2 times the nominal length of the loaded stent. When the stent is released, the distal end of the rigid pushing tube moves to the distal end and enters the stent binding tube 3, and the proximal end of the stent binding tube 3 moves to the proximal end, so that the stent is released at the position of a target lesion blood vessel in an in-situ compensation manner.
Example 2
In this example, the stent was woven with 0.18mm ni-ti wires, 7.0mm in diameter, 6 stent weaving heads, a weaving angle a1 of 118.5 °, the stent was loaded and compressed in the stent constraining tube, and the stent released from the stent constraining tube had an axial shrinkage of 46.6%, at which time the inner diameter of the stent constraining tube was about 1.9 mm. In this embodiment, the rack and pinion transmission device is used to control the stent restraining tube 3 and the stent pushing tube 2 to move in opposite directions. The transmission device comprises two racks S1 and S2 moving in opposite directions and a gear S3, wherein the rack S2 is connected with the bracket bounding tube through a conveyor belt and a bracket bounding tube joint, and the rack S1 is connected with the bracket pushing tube through a rigid pushing tube. By mounting the rotary handle on the gear S3, the drive gear S3 rotates clockwise, which in turn drives the racks S1 and S2 to move toward each other.
Example 3
In this example, the stent was woven with 0.15mm ni-ti wires, 6.0mm in diameter, 6 stent weaving heads, a weaving angle a1 of 119 °, the stent was loaded and compressed in the stent constraining tube, and the stent released from the stent constraining tube had an axial shrinkage of 46.9%, at which time the inner diameter of the stent constraining tube was about 1.65 mm. In this embodiment, the same rack and pinion transmission device as that of embodiment 2 is used to control the stent restraining tube 3 and the stent pushing tube 2 to move in opposite directions. Except that the preoperative separable gun handle drive gear S3 is used for clockwise rotation.
The specific process is as follows: the bracket binding tube 3 is connected with the hard connecting piece 11 of the handle through the buckle 15, and the hard connecting piece 11 drives the bracket binding tube 3 to move towards the far end when moving towards the far end (right end); the stent propelling tube 2 is also connected with the rigid connecting piece 12 of the handle through a buckle, and when the rigid connecting piece 12 moves towards the near end (left end), the stent propelling tube 2 is driven to move towards the near end. While the hard links 11 and 12 are moved towards each other by the gun type handles 13 and 14, thereby driving the stent restraining tube 3 and the stent pushing tube 2 to keep moving towards each other.
Still further, the handle and stent constraining tube stent pusher tube may be assembled for use prior to surgery. The buckle 15 is composed of 152 and 151, as shown in fig. 6, the 152 is fixed on the surface of the stent binding tube 3, and the 151 is fixed on the hard connecting member 11. Before operation, the support 151 is clamped in the inter-ring gap of the support 152, so that the rigid connecting piece 11 is driven by the handle to drive the support binding tube 3 to move.
The same holds 152 to the surface of the stent push tube 2 and 151 to the hard coupling 12. Before operation, the tube 151 is clamped in the inter-ring gap of the tube 152, so that the rigid connecting piece 12 is driven by the handle to drive the bracket pushing tube 2 to move.
Wherein, the hard connecting member 11 is connected to S2, and the hard connecting member 12 is connected to S1. Handles 13 and 14 drive S3 clockwise. The driving process is the same as the conventional gun type motion mechanism.
Study on 1-year patency rate of different release effects of braided stent
The current clinical results show (as shown in fig. 7) that the 1-year patency rate of the blood vessels with different release effects of the braided stent is released in a reciprocating manner, only 36% of the stents achieve the release of the stent according to the nominal length, 50% of the stents are released in an elongated manner, and 14% of the stents are released in a compressed manner. Wherein the patency of the stent vessel released by elongation is reduced by at least 15%. The treatment effect of the woven stent is seriously influenced. The self-expansion type braided stent avoids the stent from being excessively elongated or compressed and released from the design angle, and the stent propelling tube moves towards the far end in the releasing process, so that the axial shortening amount after the stent is released is compensated, the stent vessel patency rate of the braided stent is improved, and the treatment effect of the stent is improved.
All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.
Claims (8)
1. A stent delivery device, the delivery device comprising:
(a) a self-expanding braided stent;
(b) a conveying member;
the length of the stent before release is 1.82-2.22 times of the length of the stent after release; the axial short shrinkage rate of the bracket is 45-55%; the weaving angle of the stent is 90-140 degrees, the outer diameter of the stent after being loaded and compressed is 1.6-2.13mm, and the wire diameter of the stent is 0.1-0.2 mm; the diameter of the bracket is 4-8 mm;
the conveying component comprises an inner pipe (1), a support pushing pipe (2), a support binding pipe (3), a handle shell (4), a driving device joint (5), a luer joint (6), a support binding pipe joint (7), a support pushing pipe driving device (8) and a transmission device;
the support pushing pipe driving device (8) comprises a rigid pushing pipe connected with the support pushing pipe (2) and a driving handle connected with the rigid pushing pipe, the far end of the rigid pushing pipe is connected with the near end of the support pushing pipe (2), and a connector (5) of the driving device is fixed on the outer surface of the rigid pushing pipe;
the distal end of the rigid push tube is placed in the stent constraining tube;
the driving handle connected with the rigid pushing pipe is provided with a scale display for displaying the moving distance of the rigid pushing pipe to the far end;
the distance between the proximal end of the stiff pusher tube and the proximal end of the stent constraining tube is 2-2.5 times the nominal length of the loaded self-expanding braided stent;
the inner tube is provided with a developing ring mark for indicating the positions of the near end and the far end after the stent is released;
the transmission device consists of a conveying belt and a fixed pulley, the support binding pipe is used for binding a loaded support, the transmission device consists of a conveying belt and a fixed pulley, the conveying belt penetrates through the fixed pulley, one end of the conveying belt is connected with the outer surface of the support binding pipe through a support binding pipe joint, the support binding pipe joint is fixed on the outer surface of the near end of the support binding pipe, the near end of the support pushing pipe is connected with the support pushing pipe driving device, and the other end of the conveying belt is connected with the support pushing pipe driving device through the driving device joint; or the transmission device consists of a gear and a rack, the stent binding tube is used for binding a loaded stent, the transmission device consists of two racks S1 and S2 which move in opposite directions and a gear S3, the rack S2 is connected with the stent binding tube through a conveyor belt and a stent binding tube joint, the rack S1 is connected with the stent pushing tube through a rigid pushing tube and a stent pushing tube, the rack S1 and the rack S2 are driven to move in opposite directions through the clockwise motion of the gear S3, the stent binding tube joint is fixed on the outer surface of the proximal end of the stent binding tube, and the proximal end of the stent pushing tube is connected with the stent pushing tube driving device;
the driving device joint and the support binding pipe joint move oppositely along the hard sliding rod.
2. The stent delivery device of claim 1, wherein the pre-stent release length is 1.9 to 1.95 times the post-stent release length.
3. The stent delivery device of claim 1, wherein the stent loaded compressed outer diameter is 1.75-1.9 mm.
4. The stent delivery device of claim 1, wherein the number of braiding ends of the stent is 4-8.
5. The stent delivery device of claim 1, wherein the stent is woven at an angle of 115 ° and 125 °.
6. The delivery device according to claim 1, wherein the stent constraining tube (3) has an outer diameter of 2.0-2.33 mm.
7. The delivery device of claim 1, wherein said stent constraining tube has an inner diameter of 1.6-2.13 mm.
8. The delivery device of claim 1, wherein said rack and pinion assembly comprises a rack and pinion drive mechanism, said rack and pinion drive mechanism being driven by a pistol-type handle, said pistol-type handle and said rack comprising a separate handle;
the bracket binding tube is connected with a hard connecting piece of the gun-type handle through a buckle, and the hard connecting piece drives the bracket binding tube to move towards the far end when moving towards the far end; the bracket propelling tube is also connected with the rigid connecting piece of the gun type handle through the buckle, when the rigid connecting piece moves towards the near end, the bracket propelling tube is driven to move towards the near end, and the rigid connecting piece realizes opposite movement through the gun type handle, so that the bracket restraining tube and the bracket propelling tube (2) are driven to keep opposite movement.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811488344.6A CN109602522B (en) | 2017-12-07 | 2017-12-07 | Self-expanding braided stent and conveying device thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811488344.6A CN109602522B (en) | 2017-12-07 | 2017-12-07 | Self-expanding braided stent and conveying device thereof |
| CN201711285758.4A CN107837135B (en) | 2017-12-07 | 2017-12-07 | Self-expansion type braided support and its conveying device |
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| CN201711285758.4A Division CN107837135B (en) | 2017-12-07 | 2017-12-07 | Self-expansion type braided support and its conveying device |
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| CN109602522B true CN109602522B (en) | 2019-12-27 |
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| CN201711285758.4A Active CN107837135B (en) | 2017-12-07 | 2017-12-07 | Self-expansion type braided support and its conveying device |
| CN201811488344.6A Active CN109602522B (en) | 2017-12-07 | 2017-12-07 | Self-expanding braided stent and conveying device thereof |
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| CN107837135B (en) * | 2017-12-07 | 2019-12-03 | 苏州恒瑞宏远医疗科技有限公司 | Self-expansion type braided support and its conveying device |
| US20210386567A1 (en) * | 2018-10-05 | 2021-12-16 | W. L. Gore & Associates, Inc. | Constraining mechanisms for selective deployment and associated methods |
| CN113827386B (en) * | 2021-11-29 | 2022-03-29 | 艾柯医疗器械(北京)有限公司 | Self-expanding type stent leading-in device |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5968052A (en) * | 1996-11-27 | 1999-10-19 | Scimed Life Systems Inc. | Pull back stent delivery system with pistol grip retraction handle |
| US7052511B2 (en) * | 2002-04-04 | 2006-05-30 | Scimed Life Systems, Inc. | Delivery system and method for deployment of foreshortening endoluminal devices |
| ITTO20030037A1 (en) * | 2003-01-24 | 2004-07-25 | Sorin Biomedica Cardio S P A Ora S Orin Biomedica | CATHETER DRIVE DEVICE. |
| DE102006004123A1 (en) * | 2006-01-25 | 2007-08-02 | Jotec Gmbh | Feed system for the insertion of expandable stents into cardiac arteries uses a hand held grip |
| WO2012082453A1 (en) * | 2010-12-16 | 2012-06-21 | Cook Medical Technologies Llc | Handle control system for a stent delivery system |
| CN102283728B (en) * | 2011-06-28 | 2014-09-10 | 先健科技(深圳)有限公司 | Lumen bracket conveying system |
| CN110063825B (en) * | 2013-11-08 | 2021-09-14 | 波士顿科学国际有限公司 | Endoluminal device |
| CN106456349B (en) * | 2014-03-24 | 2018-07-06 | 波士顿科学国际有限公司 | Self-expanding stent transport system |
| CN206102784U (en) * | 2016-08-15 | 2017-04-19 | 苏州天鸿盛捷医疗器械有限公司 | Support conveyer |
| CN107837135B (en) * | 2017-12-07 | 2019-12-03 | 苏州恒瑞宏远医疗科技有限公司 | Self-expansion type braided support and its conveying device |
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2017
- 2017-12-07 CN CN201711285758.4A patent/CN107837135B/en active Active
- 2017-12-07 CN CN201811488344.6A patent/CN109602522B/en active Active
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| CN109602522A (en) | 2019-04-12 |
| CN107837135A (en) | 2018-03-27 |
| WO2019109981A1 (en) | 2019-06-13 |
| CN107837135B (en) | 2019-12-03 |
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