CN118649011B - A vascular stent system - Google Patents
A vascular stent system Download PDFInfo
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- CN118649011B CN118649011B CN202411124142.9A CN202411124142A CN118649011B CN 118649011 B CN118649011 B CN 118649011B CN 202411124142 A CN202411124142 A CN 202411124142A CN 118649011 B CN118649011 B CN 118649011B
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Classifications
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (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
本发明涉及一种血管支架系统，其包括支架组件和输送系统，支架组件包括多个沿轴向排列且相互独立设置的自膨支架单元，输送系统包括内管、连接件、外鞘管、操作手柄、第一释放机构和第二释放机构，内管外部固定设置多个沿内管的轴向间隔分布的限位部，自膨支架单元套设在内管上且相邻两个限位部之间设有一个自膨支架单元；连接件用于将自膨支架单元可活动地连接束缚在内管上；外鞘管相对可活动地套设在内管上；操作手柄设置在外鞘管和所述内管的近端；第一释放机构设置在操作手柄和所述外鞘管之间，用于驱动外鞘管相对内管沿所述内管的轴向滑动；第二释放机构设置在操作手柄和/或内管上，用于断开自膨支架单元和内管之间的连接。
The present invention relates to a vascular stent system, which comprises a stent assembly and a delivery system. The stent assembly comprises a plurality of self-expanding stent units arranged axially and independently of each other. The delivery system comprises an inner tube, a connector, an outer sheath tube, an operating handle, a first release mechanism and a second release mechanism. A plurality of limiting portions spaced along the axial direction of the inner tube are fixedly arranged on the outer side of the inner tube. The self-expanding stent unit is sleeved on the inner tube and a self-expanding stent unit is provided between two adjacent limiting portions. The connector is used to movably connect and restrain the self-expanding stent unit on the inner tube. The outer sheath tube is relatively movably sleeved on the inner tube. The operating handle is arranged at the proximal end of the outer sheath tube and the inner tube. The first release mechanism is arranged between the operating handle and the outer sheath tube, and is used to drive the outer sheath tube to slide relative to the inner tube along the axial direction of the inner tube. The second release mechanism is arranged on the operating handle and/or the inner tube, and is used to disconnect the connection between the self-expanding stent unit and the inner tube.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a vascular stent system.
Background
Atherosclerosis often results in a variety of conditions and even life threatening. For example, atherosclerosis of coronary arteries supplying blood to the heart can lead to stenosis of the lumen of the coronary arteries, insufficient blood supply to the heart muscle, angina pectoris, secondary thrombosis if atheromatous plaque breaks, occlusion of the coronary arteries, and myocardial infarction. Cerebral angiogenic atherosclerosis can lead to the initiation of stroke by stenosis or blockage of the lumen of a blood vessel supplying blood to brain tissue. Carotid atherosclerosis can cause carotid stenosis or blockage resulting in cerebral infarction. If the atheromatous plaque breaks, the fragments fall off and block cerebral arteries with blood flow, and cerebral infarction can be caused. Atherosclerosis of lower limb arteries can cause peripheral vascular disease, and initial patients may have lameness, which in turn may cause various complications due to insufficient blood supply to lower limb, and serious patients may even need amputation.
The most common modes of endoluminal intervention used today to treat the above conditions are percutaneous transluminal balloon dilation and endoluminal stent implantation. The patency rates of different parts of the former are different, but are far lower than those of the latter.
The vascular stents used in the endoluminal stent implantation are mainly divided into two types, namely cutting type and braiding type. The braided stent is mainly braided by metal wires and is integrally braided and formed. The cutting type support comprises a plurality of closed rings and connecting parts, wherein the plurality of closed rings are distributed at intervals along the axial direction, and the connecting parts are used for connecting the two adjacent closed rings. While woven stents have some flexibility and fatigue resistance, but very high axial shrinkage and relatively weak radial support, cut stents generally have better radial support and less axial shrinkage, but less fatigue resistance and flexibility. On the basis of the two, the high polymer film is used as a carrier, the braided or cut closed ring is used as a tectorial membrane bracket of a supporting structure, the axial shrinkage rate of the tectorial membrane bracket is higher than that of the cut type bracket, the fatigue resistance and the flexibility of the tectorial membrane bracket are stronger than those of the braided type bracket, but the compressible maximum loading outer diameter is larger, and the tectorial membrane bracket is difficult to be applied to the blood vessel with the smaller diameter.
Because calcification on two sides of the vessel wall of the lesion part causes larger gradient difference with the inner diameter of the vessel at the normal vessel part, and the original vessel is not uniform in inner diameter from the anatomical point of view, after the main flow stent is implanted into a human body, the radial force applied to the vessel wall and the outer diameter of the main flow stent in a stent release state preset in the manufacturing stage cannot meet the best working state, and the main flow stent has the advantages that 1. The radial force is too low or the outer diameter is too small, the stent implanted in the vessel at the lesion part has insufficient radial force to cause stent collapse or displacement of the section stent at the normal vessel part, 2. The radial force is too high or the outer diameter is too large, the stent transition expansion implanted in the normal vessel part causes damage to the vessel, and 3. Adjacent units of the stent implanted at the site with larger gradient difference in the inner diameter are mutually influenced, so that a metal rod breaks to damage the vessel wall. And the above problems are more pronounced when implanting long gauge stents. Therefore, for the lesion part with larger inner diameter change, a stent system capable of flexibly setting and adjusting the inner diameter of the stent according to the inner diameter change of the blood vessel is not available at present, the existing stent system still has a lesion position which cannot be overcome, in particular to a lower limb artery with larger movement amplitude and larger inner diameter change, and no main flow is available for the blood vessel stent below the knee at present.
There is a strong need for a spring loaded, modular support in which adjacent support rings are independent of each other in the released condition and the radial forces and outer diameters do not affect each other.
Disclosure of Invention
The invention aims to provide a stent system which has better compliance and fatigue resistance and can be highly matched with the change of the inner diameter of a blood vessel in a release state and can be used for arterial blood vessels with frequent movement and complex working conditions.
In order to achieve the above purpose, the invention adopts the following technical scheme:
a vascular stent system includes a stent assembly and a delivery system.
The bracket component comprises a plurality of self-expanding bracket units which are arranged along the axial direction and are mutually independent, and the self-expanding bracket units are annular and have radial expansion states and radial compression states.
The delivery system includes an inner tube, a connector, an outer sheath, an operating handle, a first release mechanism, and a second release mechanism. The self-expanding stent comprises an inner tube, a plurality of limiting parts, a connecting piece, an operating handle, a first release mechanism and a second release mechanism, wherein the limiting parts are fixedly arranged outside the inner tube and are distributed at intervals along the axial direction of the inner tube, the self-expanding stent units are sleeved on the inner tube, one self-expanding stent unit is arranged between two adjacent limiting parts, the connecting piece is used for movably connecting and binding each self-expanding stent unit on the inner tube, the outer sheath is sleeved on the inner tube relatively movably, the operating handle is arranged at the proximal ends of the outer sheath and the inner tube, the first release mechanism is arranged between the operating handle and the outer sheath and is used for driving the outer sheath to slide along the axial direction of the inner tube relative to the inner tube, and the second release mechanism is arranged on the operating handle and/or the inner tube and is used for disconnecting each self-expanding stent unit from the inner tube.
The vascular stent system of the present invention has an assembled state, a partially released state, and a fully released state.
When the vascular stent system is in the assembled state, the self-expanding stent unit is positioned between the inner tube and the outer sheath tube and connected with the inner tube through the connecting piece, and the self-expanding stent unit is in the radial compression state and has a movement tendency converted from the radial compression state to the radial expansion state.
When the vascular stent system is in the partially released state, the self-expanding stent unit is located outside of the inner tube and the outer sheath tube and is still bound to the inner tube by the connection of the connector, the self-expanding stent unit being in the radially expanded state.
When the vascular stent system is in the fully released state, the self-expanding stent unit is located outside of the inner tube and the outer sheath and disconnected from the inner tube, the self-expanding stent unit being in the radially expanded state.
According to some embodiments, the connecting piece is a wire harness, the wire harness is fixedly connected with the inner tube locally, an annular cavity extending along the axial direction of the wire harness is formed in the inner tube, a plurality of through holes for communicating the annular cavity with the outside are formed in the outer wall of the inner tube along the axial direction of the inner tube, one end of the wire harness sequentially penetrates through the through holes and the self-expanding bracket unit along the axial direction of the annular cavity and then is connected with the other end of the wire harness to form an annular coil, the self-expanding bracket unit is connected and bound to the inner tube, the wire harness is basically positioned in the annular cavity, when the vascular bracket system is in the assembled state, the wire harness is in a loose state, and when the vascular bracket system is in the partially released state, the wire harness is in a tensioning state. The second release mechanism comprises a movable cutting component arranged on the operating handle and/or the inner tube, and when the cutting component is in contact with the wire harness, the wire harness can be cut off, so that the annular coil is broken into a line segment fixedly connected with the inner tube.
Preferably, the through holes include a plurality of rows arranged at intervals along a circumferential direction of the inner tube, and the wire harness includes a plurality of rows arranged at intervals along the circumferential direction of the inner tube.
More preferably, the self-expandable stent unit includes a wavy annular structure forming peaks and valleys in a circumferential direction, and the peaks and/or valleys of different self-expandable stent units located in the same radial direction are bound to the inner tube by the same wire harness connection.
More preferably, the proximal end of the inner tube extends to the outside of the proximal end of the operating handle, the proximal end of the inner tube is provided with a fixing block, the cutting member is disposed at the proximal end of the inner tube and located at the outer side of the fixing block, the wire harness is wound on the fixing block and located partially between the cutting member and the outer surface of the fixing block, and when the cutting member is brought close to the fixing block by an external force, the wire harness can be contacted with and cut off.
More preferably, the material of the connecting piece is degradable or non-degradable material, for example, the connecting piece is composed of a single strand of non-degradable suture thread, the material is preferably high polymer material PET, the material of the sharp edge of the cutting component for cutting the connecting piece is preferably stainless steel, for example SUS304, and the material of the other components of the vascular stent system is preferably high polymer material, including but not limited to PEBAX, PEEK, PC, ABS, PP, POM, PE.
According to other embodiments, the connecting piece includes a plurality of the axial interval setting along the inner tube, the connecting piece is the pencil, be formed with in the inner tube along its axial direction annular cavity that extends, a plurality of will be seted up along its axial on the outer wall of inner tube annular cavity and outside intercommunication's through-hole, second release mechanism is for can follow the axial of annular cavity sets up the push rod in the annular cavity with sliding, the push rod is followed the axial extension of annular cavity, a plurality of bar grooves are seted up along its axial interval on the push rod, the proximal end of bar groove is equipped with cutting member just cutting member with can cut off when the connecting piece contacts the connecting piece, one end of connecting piece with push rod looks fixed connection, pass a self-expanding support unit after the other end passes a through-hole, pass a bar groove after passing same through-hole again, finally with annular cavity's inner wall looks fixed connection. The through hole through which the connector passes is distant from the bar slot and is in the distal direction of the bar slot when the vascular stent system is in the assembled state, the portion of the connector located in the bar slot is in abutting contact with the distal end of the bar slot, and the through hole through which the connector passes is close to and substantially aligned with the bar slot when the vascular stent system is in the partially released state, the connector being located approximately in the middle of the bar slot.
Preferably, the through holes include a plurality of rows arranged at intervals along the circumferential direction of the inner tube, the connection member includes a plurality of rows arranged at intervals along the circumferential direction of the inner tube, the push rod is tubular coaxial with the inner tube and the bar-shaped groove includes a plurality of rows arranged at intervals along the circumferential direction of the push rod.
Preferably, the self-expandable stent unit comprises a wave-shaped circular ring structure with peaks and valleys formed in the circumferential direction, and the peaks and/or valleys of each self-expandable stent unit are respectively connected and bound to the inner tube by one connecting piece.
More preferably, the proximal end of the inner tube extends to the outside of the proximal end of the operating handle, the proximal end of the inner tube is provided with a relief groove extending from the proximal end thereof to the distal end direction, the proximal end of the push rod extends to the outside of the proximal end of the inner tube, the proximal end of the push rod is provided with a push-pull portion, and the push-pull portion is slidably inserted in the relief groove.
More preferably, the material of the connecting piece is degradable or non-degradable, the material of the sharp edge of the cutting component for cutting the connecting piece is preferably stainless steel, such as SUS304, and the material of the other components of the vascular stent system is preferably polymer material, including but not limited to PEBAX, PEEK, PC, ABS, PP, POM, PE the material of the connecting piece is double-strand metal material.
More preferably, the connection means of the connection member to the push rod and the inner tube includes, but is not limited to, bonding, welding or tying dead knots.
According to still other embodiments, the connecting member includes a plurality of wire harness loops arranged at intervals along an axial direction of the inner tube, the connecting member is a wire harness loop wound on the self-expanding bracket unit, an annular cavity extending along an axial direction of the inner tube is formed in the inner tube, a plurality of through holes for communicating the annular cavity with the outside are formed in an outer wall of the inner tube along an axial direction of the inner tube, the second release mechanism includes a push rod slidably arranged in the annular cavity along an axial direction of the annular cavity, the push rod extends along an axial direction of the annular cavity, a plurality of deformable hooks are arranged on the push rod at intervals along an axial direction of the push rod, the hooks include an arm portion and a hook portion, one end of the arm portion is connected with the inner tube in a relatively rotatable manner, and the hook portion is arranged on the other end of the arm portion. When the vascular stent system is in the assembled state, the hook is positioned in the annular cavity, a part of the connecting piece penetrates through a through hole to be matched and connected with the hook part, and the hook part of the hook is positioned below the through hole. When the vascular stent system is in the partial release state, the arm part of the hook penetrates through the through hole and is tensioned, the hook part is connected with the connecting piece in a matching way, and the connecting part of the arm part and the inner tube is positioned below the through hole. When the vascular stent system is in the completely released state, the arm part of the hook penetrates through the through hole, the hook part is separated from the connecting piece, and the connecting position of the arm part and the inner tube is positioned in the distal end direction of the through hole.
Preferably, the through holes comprise a plurality of rows arranged at intervals along the circumferential direction of the inner tube, the self-expandable stent units comprise wave-shaped circular ring structures forming wave crests and wave troughs in the circumferential direction, each wave crest and/or wave trough of the self-expandable stent unit is provided with one connecting piece respectively, the push rod is tubular coaxial with the inner tube and the hooks comprise a plurality of rows arranged at intervals along the circumferential direction of the push rod.
More preferably, the proximal end of the inner tube extends to the outside of the proximal end of the operating handle, the proximal end of the inner tube is provided with a avoiding groove extending from the proximal end to the distal end direction thereof, the proximal end of the push rod extends to the outside of the proximal end of the inner tube, the proximal end of the push rod is provided with a push-pull part, and the push-pull part is positioned in the avoiding groove.
In this embodiment, the position of the self-expanding stent unit may also be fine-tuned by manipulating the wire harness at the proximal end of the inner tube after the outer sheath is withdrawn.
More preferably, the material of the connecting piece and the pushing rod is NiTi wire, the material of the connecting piece is single-strand degradable suture thread, the material is preferably polymer material PLGA, and the material of other parts of the vascular stent system is preferably polymer material, including but not limited to PEBAX, PEEK, PC, ABS, PP, POM, PE.
Preferably, the number of peaks and valleys of each of the self-expanding stent units is equal.
Preferably, the first release mechanism comprises a rack and a gear assembly which are arranged on the operating handle and are mutually matched and connected, the distal end of the rack is fixedly connected with the outer sheath tube, the operating handle is fixedly connected with the proximal end of the inner tube, the gear assembly is rotatably arranged on the operating handle, and the gear assembly can drive the rack to axially move along the gear assembly when working.
More preferably, the gear assembly includes a drive wheel and a driven wheel. The driving wheel is rotatably arranged on the operating handle, the driven wheel is connected with the driving wheel and the rack in a matched mode, and when external force rotates the driving wheel, the driving wheel drives the driven wheel to rotate so as to drive the rack to move, and then the outer sheath tube is driven to slide relative to the inner tube.
In the present invention, the diameters of the stent units in the expanded state are equal or different, and specifically, different self-expanding stent units may be selected according to the change of the inner diameters of the blood vessel lesion and the blood vessel in the vicinity thereof.
Preferably, the distal end of the inner tube is provided with a guide portion which extends all the way out of the distal end portion of the outer sheath. The guide portion is used for guiding the bracket assembly to a lesion.
Preferably, each self-expanding stent unit is provided with a developing mark for positioning the intraoperative and postoperative stent components.
Preferably, the self-expanding stent units are made of nickel-titanium alloy.
The invention also provides a using method of the vascular stent system, which comprises the following steps:
(1) Venting the vascular stent system;
(2) Introducing the vascular stent system into the lesion site along the guide wire, and adjusting the vascular stent system to an expected position;
(3) Controlling the first release mechanism to withdraw the outer sheath tube, and expanding the self-expanding stent unit;
(4) Controlling the first release mechanism to disconnect the self-expanding stent unit from the inner tube;
(5) The delivery system is withdrawn from the body.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
The stent components in the vascular stent system are mutually independent, are in a state and a modularized stent with the radial force and the outer diameter not mutually influenced, and realize the delivery and release of the stent components through a matched delivery system. When the vascular stent system is used, the size of each independent self-expanding stent unit can be selected according to the vascular stenosis condition of a lesion part of a patient and the inner diameters of adjacent normal blood vessels, so that the stent component has more excellent suitability and meets the human anatomy. Compared with a covered stent, the vascular stent system provided by the invention has a smaller loading outer diameter, greatly improves the trafficability of a conveying system, and can be suitable for a blood vessel which is severely narrow and can not be reached by the covered stent conveying system. Compared with other main flow stents (woven stents and cutting stents), the self-expanding stent units are not connected with each other, so that the compliance and fatigue resistance of the stent component are greatly enhanced, and the self-expanding stent can be used in arterial vessels with frequent movement and complex working conditions, such as lower limb below knee arterial vessels which cannot be developed in the current stent implantation.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of the overall structure (with portions at the distal end in section) of one embodiment of a vascular stent system of the present invention;
FIG. 2 is a schematic view of the distal end of the vascular stent system of FIG. 1 in a diseased region;
FIG. 3 is a schematic view of the stent assembly of the vascular stent system of FIG. 1 in a diseased site;
FIG. 4 is a schematic illustration of the structure of a self-expanding stent unit in the vascular stent system shown in FIG. 1;
FIG. 5 is a schematic view of a partial structure of an inner tube (stopper not shown) in the vascular stent system shown in FIG. 1;
FIG. 6 is a schematic cross-sectional view of the vascular stent system of example 1 in an assembled state;
FIG. 7 is an enlarged view at A in FIG. 6;
FIG. 8 is an enlarged view at B in FIG. 6;
FIG. 9 is a schematic cross-sectional view of the vascular stent system of example 1 in a partially released state;
Fig. 10 is an enlarged view of fig. 9 at C;
fig. 11 is an enlarged view of D in fig. 9;
Fig. 12 is a schematic cross-sectional structural view (delivery system withdrawing portion) of the vascular stent system of embodiment 1 in a completely released state;
FIG. 13 is an enlarged view of FIG. 12 at E;
Fig. 14 is a schematic sectional view of the vascular stent system of embodiment 2 in an assembled state;
fig. 15 is an enlarged view of F in fig. 14;
FIG. 16 is a schematic cross-sectional view of the vascular stent system of example 2 in a partially released state;
fig. 17 is an enlarged view at G in fig. 16;
fig. 18 is a schematic cross-sectional structure of the vascular stent system of example 2 in a partially released state (state where the cutting member cuts the connecting member);
fig. 19 is an enlarged view of H in fig. 18;
FIG. 20 is a schematic cross-sectional view of the vascular stent system of example 2 in a fully released state;
FIG. 21 is an enlarged view of the portion I of FIG. 20;
FIG. 22 is a schematic cross-sectional view of the vascular stent system of example 3 in an assembled state;
fig. 23 is an enlarged view at J in fig. 22;
FIG. 24 is a schematic cross-sectional view of the vascular stent system of example 3 in a partially released state;
FIG. 25 is an enlarged view of K in FIG. 24;
Fig. 26 is a schematic cross-sectional structural view of the vascular stent system of embodiment 3 in a partially released state (with the hooks separated from the connectors);
fig. 27 is an enlarged view of L in fig. 26;
FIG. 28 is a schematic cross-sectional view of the vascular stent system of example 3 in a fully released state;
figure 29 is an enlarged view of M in figure 28,
In the above figures:
11. The self-expanding stent comprises a self-expanding stent unit, 111, a trough, 112, a crest, 21, an inner tube, 211, a limiting part, 212, an annular cavity, 213, a through hole, 214, a fixed block, 215, a push rod, 2151, a strip-shaped groove, 216, a hook, 22, a connecting piece, 23, an outer sheath, 24, an operating handle, 25, a first releasing mechanism, 251, a rack, 252, a driving wheel, 253, a driven wheel, 26, a second releasing mechanism, 261, a cutting part, 3, a blood vessel, 4 and a luer connector.
Detailed Description
Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
In the description of the present invention, it will be understood that distal refers to the end of the instrument or component that is distal from the operator, proximal refers to the end of the instrument or component that is proximal to the operator, axial refers to the direction parallel to the line connecting the distal end of the instrument or component to the center of the proximal end, and radial refers to the direction perpendicular to the axial, and inner and outer refer to positions defined by the distance from the center of the instrument or component, wherein inner is the position proximal to the center of the instrument or component and outer is the position distal from the center of the instrument or component. The above description of orientation words is merely for convenience in describing embodiments of the present invention and for simplicity of description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting embodiments of the present invention.
In the description of the present invention, unless explicitly stated and limited otherwise, the terms "coupled," "affixed," and the like are to be construed broadly, and may be, for example, fixedly coupled, detachably coupled, or integrally formed. The specific meaning of the above terms in the embodiments of the present invention will be understood by those of ordinary skill in the art according to specific circumstances.
In the description of the present invention, plural means two or more.
The annular cavity 212 on the inner tube 21 of the present invention may also be used for preoperative infusion venting.
The degradable material refers to a material which can be completely degraded in vivo within one to fifteen days.
The following disclosure provides many different implementations, or examples, for implementing different configurations of embodiments of the invention. In order to simplify the disclosure of embodiments of the present invention, components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present invention.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Example 1
The embodiment provides a vascular stent system and a use method thereof, and particularly as shown in fig. 6-13, the vascular stent system of the embodiment comprises a stent component and a conveying system.
Specifically, the stent assembly includes a plurality of self-expanding stent units 11 arranged in an axial direction and disposed independently of each other, the self-expanding stent units 11 being annular in shape and each having a radially expanded state and a radially compressed state. In the present embodiment, the self-expanding stent unit 11 includes a wavy annular structure in which peaks 112 and valleys 111 are formed in the circumferential direction.
Specifically, the delivery system includes an inner tube 21, a connector 22, an outer sheath 23, an operating handle 24, a first release mechanism 25, and a second release mechanism 26. The inner tube 21 is fixedly provided with a plurality of limiting parts 211 outside, the limiting parts 211 are distributed at intervals along the axial direction of the inner tube 21, the self-expanding stent units 11 are sleeved on the inner tube 21, one self-expanding stent unit 11 is arranged between two adjacent limiting parts 211, a connecting piece 22 is used for movably connecting and binding each self-expanding stent unit 11 on the inner tube 21, an outer sheath tube 23 is sleeved on the inner tube 21 relatively movably, an operating handle 24 is arranged at the proximal ends of the outer sheath tube 23 and the inner tube 21, a first release mechanism 25 is arranged between the operating handle 24 and the outer sheath tube 23 and used for driving the outer sheath tube 23 to slide along the axial direction of the inner tube 21 relative to the inner tube 21, and a second release mechanism 26 is arranged on the operating handle 24 and/or the inner tube 21 and used for disconnecting each self-expanding stent unit 11 from the inner tube 21. The vascular stent system of the present invention has an assembled state, a partially released state, and a fully released state.
In the present embodiment, when the vascular stent system is in the assembled state, the self-expanding stent unit 11 is located between the inner tube 21 and the outer sheath 23 and is connected to the inner tube 21 by the connector 22, and the self-expanding stent unit 11 is in the radially compressed state and has a movement tendency to shift from the radially compressed state to the radially expanded state. When the vascular stent system is in the partially released state, the self-expanding stent unit 11 is located outside the inner tube 21 and the outer sheath 23 and still is connected and constrained to the inner tube 21 by the connector 22, the self-expanding stent unit 11 being in the radially expanded state. When the vascular stent system is in the fully released state, the self-expanding stent unit 11 is located outside the inner tube 21 and the outer sheath 23 and disconnected from the inner tube 21, and the self-expanding stent unit 11 is in the radially expanded state.
More specifically, in this embodiment, the connecting member 22 is a wire harness, the wire harness is fixedly connected to the inner tube 21 locally, an annular cavity 212 extending along the axial direction of the wire harness is formed in the inner tube 21, a plurality of through holes 213 communicating the annular cavity 212 with the outside are formed in the outer wall of the inner tube 21 along the axial direction of the inner tube, one end of the wire harness sequentially passes through the through holes 213 and the self-expandable stent unit 11 along the axial direction of the annular cavity 212 and then is connected to the other end of the wire harness to form an annular coil and connect and bind the self-expandable stent unit 11 to the inner tube 21, the wire harness is basically located in the annular cavity 212, when the vascular stent system is in an assembled state, the wire harness is in a loose state, and when the vascular stent system is in a partially released state, the wire harness is in a tensioned state. The second release mechanism 26 includes a movable cutting member 261 provided on the inner tube 21, and when the cutting member 261 contacts the wire harness, the wire harness can be cut off so that the loop coil is broken into a line segment fixedly connected with the inner tube 21.
More specifically, in the present embodiment, the through holes 213 include a plurality of rows arranged at intervals along the circumferential direction of the inner tube 21, and the wire harness includes a plurality of peaks 112 and valleys 111 of the different self-expanding stent units 11 located in the same radial direction are bound to the inner tube 21 by the same wire harness connection.
More specifically, in the present embodiment, the proximal end of the inner tube 21 extends to the outside of the proximal end of the operating handle 24, the proximal end of the inner tube 21 is provided with the fixing block 214, the cutting member 261 is provided at the proximal end of the inner tube 21 and located outside the fixing block 214, the wire harness is wound around the fixing block 214 and located partially between the cutting member 261 and the outer surface of the fixing block 214, and when the cutting member 261 is brought close to the fixing block 214 by an external force, it can be brought into contact with the wire harness and cut off it.
More specifically, in this embodiment, the first release mechanism 25 includes a rack 251 and a gear assembly, which are disposed on the operating handle 24 and are cooperatively connected, wherein the distal end of the rack 251 is fixedly connected to the outer sheath 23, the operating handle 24 is fixedly connected to the proximal end of the inner tube 21, the gear assembly is rotatably disposed on the operating handle 24, and the gear assembly is operative to drive the rack 251 to move axially along the gear assembly. The gear assembly includes a drive wheel 252 and a driven wheel 253. The driving wheel 252 is rotatably disposed on the operating handle 24, and the driven wheel 253, the driving wheel 252 and the rack 251 are cooperatively connected, when an external force rotates the driving wheel 252, the driving wheel 252 drives the driven wheel 253 to rotate and then drives the rack 251 to move, so as to drive the outer sheath 23 to slide relative to the inner tube 21.
More specifically, in the present embodiment, the material of the connector 22 is a double-strand metal material NiTi wire, the material of the cutting member 261 for cutting the sharp edge of the connector 22 is SUS304, and the material of the other members of the vascular stent system is a polymer material.
More specifically, in the present embodiment, the distal end of the inner tube 21 is provided with a guide portion which always protrudes from the distal end portion of the outer sheath 23. The guide part is used for guiding the bracket component to the lesion. Each self-expanding stent unit 11 is provided with a development marker for intraoperative and postoperative stent assembly positioning, respectively. The self-expanding stent units 11 are each made of nickel-titanium alloy.
The application method of the embodiment is as follows:
(1) Injecting heparin saline into the annular cavity 212 to vent the vascular stent system (by injecting fluid through luer fitting 4 removably mounted at the proximal end of inner tube 21);
(2) Introducing the vascular stent system into the lesion of the blood vessel 3 along the guide wire, and adjusting the vascular stent system to an expected position;
(3) The rotation driving wheel 252 withdraws the outer sheath 23, and the self-expanding stent unit 11 expands;
(4) Pressing the cutting member 261 to cut the connector 22;
(5) The delivery system is withdrawn from the body.
Example 2
The present embodiment provides another vascular stent system and a method for using the same, and is particularly shown in fig. 14 to 21.
The vascular stent system of this embodiment includes a stent assembly and a delivery system, wherein the stent assembly is the same as embodiment 1 and the delivery system is slightly different from embodiment 1.
Specifically, in this embodiment, the connecting member 22 includes a plurality of connecting members 22 disposed at intervals along an axial direction of the inner tube 21, the connecting members 22 are wire bundles, an annular cavity 212 extending along an axial direction of the connecting members is formed in the inner tube 21, a plurality of through holes 213 for communicating the annular cavity 212 with the outside are formed in an outer wall of the inner tube 21 along the axial direction of the inner tube, the second release mechanism 26 is a push rod 215 slidably disposed in the annular cavity 212 along the axial direction of the annular cavity 212, the push rod 215 extends along the axial direction of the annular cavity 212, a plurality of bar-shaped grooves 2151 are formed in the push rod 215 along the axial intervals, a cutting member 261 is disposed at a proximal end of the bar-shaped groove 2151, the cutting member 261 can cut off the connecting members 22 when contacting the connecting members 22, one end of the connecting members 22 is fixedly connected with the push rod 215, and the other end passes through a self-expanding bracket unit 11 after passing through a through hole 213, then passes through a bar-shaped groove 2151 after passing through the same through the through hole, and finally is fixedly connected with an inner wall of the annular cavity 212. When the vascular stent system is in the assembled state, the through hole 213 through which the connector 22 passes is distant from the bar-shaped groove 2151 and the through hole 213 is in the distal direction of the bar-shaped groove 2151, the portion of the connector 22 located in the bar-shaped groove 2151 is in contact with the distal end of the bar-shaped groove 2151, and when the vascular stent system is in the partially released state, the through hole 213 through which the connector 22 passes is close to and substantially aligned with the bar-shaped groove 2151, the connector 22 being located substantially in the middle of the bar-shaped groove 2151.
Specifically, in the present embodiment, the through holes 213 include a plurality of rows spaced apart along the circumferential direction of the inner tube 21, the connection members 22 include a plurality of rows spaced apart along the circumferential direction of the inner tube 21, the push rod 215 is tubular coaxially with the inner tube 21, and the bar-shaped grooves 2151 include a plurality of rows spaced apart along the circumferential direction of the push rod 215.
Specifically, in the present embodiment, the self-expandable stent units 11 include a wavy annular structure in which peaks 112 and valleys 111 are formed in the circumferential direction, and the valleys 111 at the proximal end of each self-expandable stent unit 11 are respectively connected and bound to the inner tube 21 by one connecting member 22.
Specifically, in the present embodiment, the proximal end of the inner tube 21 extends to the outside of the proximal end of the operating handle 24, the proximal end of the inner tube 21 is provided with a relief groove extending in the distal direction from the proximal end thereof, the proximal end of the push rod 215 extends to the outside of the proximal end of the inner tube 21, the proximal end of the push rod 215 is provided with a push-pull portion, and the push-pull portion is slidably inserted in the relief groove.
Specifically, in this embodiment, the connecting member 22 is formed by a non-degradable suture, the connecting member 22 is bonded to the push rod 215 and the inner tube 21, the cutting member 261 is made of SUS304 for cutting the sharp edge of the connecting member 22, and the other members of the vascular stent system are preferably made of polymer materials.
More specifically, in the present embodiment, the distal end of the inner tube 21 is provided with a guide portion which always protrudes from the distal end portion of the outer sheath 23. The guide part is used for guiding the bracket component to the lesion. Each self-expanding stent unit 11 is provided with a development marker for intraoperative and postoperative stent assembly positioning, respectively. The self-expanding stent units 11 are each made of nickel-titanium alloy.
The application method of the embodiment is as follows:
(1) Injecting heparin saline into the annular cavity 212 to vent the vascular stent system (by injecting fluid through luer fitting 4 removably mounted at the proximal end of inner tube 21);
(2) Introducing the vascular stent system into the lesion of the blood vessel 3 along the guide wire, and adjusting the vascular stent system to an expected position;
(3) The rotation driving wheel 252 withdraws the outer sheath 23, and the self-expanding stent unit 11 expands;
(4) Pushing the push rod 215 in the distal direction of the inner tube 21 to sever the connector 22;
(5) The delivery system is withdrawn from the body.
Example 3
The present embodiment provides another vascular stent system and a method for using the same, and is particularly shown in fig. 22-29.
The vascular stent system of this embodiment includes a stent assembly and a delivery system, wherein the stent assembly is the same as embodiment 1 and the delivery system is slightly different from embodiment 1.
Specifically, in the present embodiment, the connecting member 22 includes a plurality of wire harness loops arranged at intervals along the axial direction of the inner tube 21, the connecting member 22 is a wire harness loop wound around the self-expanding stent unit 11, an annular cavity 212 extending along the axial direction thereof is formed in the inner tube 21, a plurality of through holes 213 communicating the annular cavity 212 with the outside are formed in the outer wall of the inner tube 21 along the axial direction thereof, the second release mechanism 26 includes a push rod 215 slidably arranged in the annular cavity 212 along the axial direction of the annular cavity 212, the push rod 215 extends along the axial direction of the annular cavity 212, a plurality of deformable hooks 216 are arranged on the push rod 215 at intervals along the axial direction thereof, the hooks 216 include arm portions and hook portions, one ends of the arm portions are rotatably connected to the inner tube 21 in opposition to the other ends of the arm portions. When the vascular stent system is in the assembled state, the hooks 216 are positioned in the annular cavity 212, and a portion of the connector 22 passes through a through hole 213 to be cooperatively connected with the hooks, and the hooks of the hooks 216 are positioned below the through hole 213. When the vascular stent system is in the partially released state, the arm portion of the hook 216 passes through the through hole 213 and is tensioned, the hook portion is connected in a matched manner with the connecting piece 22, and the connection position of the arm portion and the inner tube 21 is positioned below the through hole 213. When the vascular stent system is in the fully released state, the arm portion of the hook 216 passes through the through hole 213, the hook portion is separated from the connector 22, and the connection of the arm portion and the inner tube 21 is located in the distal direction of the through hole 213.
Specifically, in the present embodiment, the through holes 213 include a plurality of rows arranged at intervals along the circumferential direction of the inner tube 21, the self-expandable stent units 11 include a wavy annular structure forming peaks 112 and valleys 111 in the circumferential direction, the valleys 111 at the proximal ends of each self-expandable stent unit 11 are respectively provided with one connecting piece 22, the push rod 215 is tubular coaxially with the inner tube 21 and the hooks 216 include a plurality of rows arranged at intervals along the circumferential direction of the push rod 215.
Specifically, in this embodiment, the proximal end of the inner tube 21 extends to the outside of the proximal end of the operating handle 24, the proximal end of the inner tube 21 is provided with a relief groove extending in the distal direction from the proximal end thereof, the proximal end of the push rod 215 extends to the outside of the proximal end of the inner tube 21, the proximal end of the push rod 215 is provided with a push-pull portion, and the push-pull portion is located in the relief groove.
Specifically, in this embodiment, the push rod 215 and the hook 216 are made of NiTi filaments, the connecting piece 22 is made of a single-strand degradable suture, the material is PLGA, and the material of other components of the vascular stent system is preferably a polymer material.
More specifically, in the present embodiment, the distal end of the inner tube 21 is provided with a guide portion which always protrudes from the distal end portion of the outer sheath 23. The guide part is used for guiding the bracket component to the lesion. Each self-expanding stent unit 11 is provided with a development marker for intraoperative and postoperative stent assembly positioning, respectively. The self-expanding stent units 11 are each made of nickel-titanium alloy.
The application method of the embodiment is as follows:
(1) Injecting heparin saline into the annular cavity 212 to vent the vascular stent system (by injecting fluid through luer fitting 4 removably mounted at the proximal end of inner tube 21);
(2) Introducing the vascular stent system into the lesion of the blood vessel 3 along the guide wire, and adjusting the vascular stent system to an expected position;
(3) The rotation driving wheel 252 withdraws the outer sheath 23, and the self-expanding stent unit 11 expands;
(4) Pushing the push rod 215 in the distal direction of the inner tube 21 to separate the hook from the connector 22;
(5) The delivery system is withdrawn from the body.
In all of the above embodiments 1 to 3, the problem of injuring the blood vessel by transitional expansion of the main stent can be avoided by selecting the self-expandable stent units 11 with a large gradient and a proper outer diameter, and meanwhile, the respective expandable stent units 11 are mutually independent, so that the phenomenon of stress concentration is avoided greatly, and the self-expandable stent can be used for the blood vessel below the knee.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (14)
1. A vascular stent system, characterized by: the vascular stent system comprises:
the bracket component comprises a plurality of self-expanding bracket units (11) which are arranged along the axial direction and are mutually independent, wherein the self-expanding bracket units (11) are annular and have a radial expansion state and a radial compression state;
A delivery system, comprising:
The self-expanding stent comprises an inner tube (21), wherein a plurality of limiting parts (211) are fixedly arranged outside the inner tube (21), the limiting parts (211) are distributed at intervals along the axial direction of the inner tube (21), the self-expanding stent units (11) are sleeved on the inner tube (21), and one self-expanding stent unit (11) is arranged between two adjacent limiting parts (211);
-a connector (22) for movably connecting and binding each self-expanding stent unit (11) to the inner tube (21);
an outer sheath tube (23) which is relatively movably sleeved on the inner tube (21);
An operation handle (24) provided at the proximal ends of the outer sheath tube (23) and the inner tube (21);
A first release mechanism (25) provided between the operation handle (24) and the outer sheath tube (23) for driving the outer sheath tube (23) to slide in the axial direction of the inner tube (21) with respect to the inner tube (21);
a second release mechanism (26) provided on the operating handle (24) and/or the inner tube (21) for disconnecting each of the self-expanding stent units (11) and the inner tube (21),
The vascular stent system has an assembled state, a partially released state and a fully released state,
When the vascular stent system is in the assembled state, the self-expanding stent unit (11) is positioned between the inner tube (21) and the outer sheath tube (23) and is connected with the inner tube (21) through the connecting piece (22), the self-expanding stent unit (11) is in the radial compression state and has a movement tendency of being converted from the radial compression state to the radial expansion state,
When the vascular stent system is in the partially released state, the self-expanding stent unit (11) is positioned outside the inner tube (21) and the outer sheath (23) and still is connected and bound to the inner tube (21) by the connecting piece (22), the self-expanding stent unit (11) is in the radially expanded state,
When the vascular stent system is in the fully released state, the self-expanding stent unit (11) is located outside the inner tube (21) and the outer sheath (23) and disconnected from the inner tube (21), the self-expanding stent unit (11) is in the radially expanded state,
The connecting piece (22) is a wire harness which is locally and fixedly connected with the inner pipe (21),
An annular cavity (212) extending along the axial direction of the inner tube (21) is formed in the inner tube (21), a plurality of through holes (213) for communicating the annular cavity (212) with the outside are formed on the outer wall of the inner tube (21) along the axial direction of the inner tube, one end of the wire harness sequentially penetrates through the through holes (213) and the self-expanding support unit (11) along the axial direction of the annular cavity (212) and then is connected with the other end of the wire harness to form an annular coil, the self-expanding support unit (11) is connected and bound to the inner tube (21), the wire harness is basically positioned in the annular cavity (212),
When the vascular stent system is in the assembled state, the wire harness is in a relaxed state,
When the vascular stent system is in the partially released state, the wire harness is in a tensioned state,
The second release mechanism (26) comprises a movable cutting part (261) arranged on the operating handle (24) and/or the inner tube (21), and when the cutting part (261) is in contact with the wire harness, the wire harness can be cut off, so that the annular coil is broken into a line segment fixedly connected with the inner tube (21).
2. The vascular stent system according to claim 1, wherein the through holes (213) include a plurality of rows arranged at intervals along a circumferential direction of the inner tube (21), and the wire harness includes a plurality of rows arranged at intervals along the circumferential direction of the inner tube (21).
3. Vascular stent system according to claim 2, characterized in that the self-expanding stent units (11) comprise a wave-shaped ring structure forming peaks (112) and valleys (111) in the circumferential direction, the peaks (112) and/or valleys (111) of different self-expanding stent units (11) located in the same radial direction being bound to the inner tube (21) by the same wire harness connection.
4. The vascular stent system according to claim 1, wherein the proximal end of the inner tube (21) extends to the outside of the proximal end of the operating handle (24), a fixing block (214) is provided at the proximal end of the inner tube (21), the cutting member (261) is provided at the proximal end of the inner tube (21) and outside the fixing block (214), and the wire harness is wound around the fixing block (214) and partially between the cutting member (261) and the outer surface of the fixing block (214) so as to be contacted with and cut off from the wire harness when the cutting member (261) is brought close to the fixing block (214) by an external force.
5. A vascular stent system, characterized by: the vascular stent system comprises:
the bracket component comprises a plurality of self-expanding bracket units (11) which are arranged along the axial direction and are mutually independent, wherein the self-expanding bracket units (11) are annular and have a radial expansion state and a radial compression state;
A delivery system, comprising:
The self-expanding stent comprises an inner tube (21), wherein a plurality of limiting parts (211) are fixedly arranged outside the inner tube (21), the limiting parts (211) are distributed at intervals along the axial direction of the inner tube (21), the self-expanding stent units (11) are sleeved on the inner tube (21), and one self-expanding stent unit (11) is arranged between two adjacent limiting parts (211);
-a connector (22) for movably connecting and binding each self-expanding stent unit (11) to the inner tube (21);
an outer sheath tube (23) which is relatively movably sleeved on the inner tube (21);
An operation handle (24) provided at the proximal ends of the outer sheath tube (23) and the inner tube (21);
A first release mechanism (25) provided between the operation handle (24) and the outer sheath tube (23) for driving the outer sheath tube (23) to slide in the axial direction of the inner tube (21) with respect to the inner tube (21);
a second release mechanism (26) provided on the operating handle (24) and/or the inner tube (21) for disconnecting each of the self-expanding stent units (11) and the inner tube (21),
The vascular stent system has an assembled state, a partially released state and a fully released state,
When the vascular stent system is in the assembled state, the self-expanding stent unit (11) is positioned between the inner tube (21) and the outer sheath tube (23) and is connected with the inner tube (21) through the connecting piece (22), the self-expanding stent unit (11) is in the radial compression state and has a movement tendency of being converted from the radial compression state to the radial expansion state,
When the vascular stent system is in the partially released state, the self-expanding stent unit (11) is positioned outside the inner tube (21) and the outer sheath (23) and still is connected and bound to the inner tube (21) by the connecting piece (22), the self-expanding stent unit (11) is in the radially expanded state,
When the vascular stent system is in the fully released state, the self-expanding stent unit (11) is located outside the inner tube (21) and the outer sheath (23) and disconnected from the inner tube (21), the self-expanding stent unit (11) is in the radially expanded state,
The connecting piece (22) comprises a plurality of connecting pieces (22) which are arranged at intervals along the axial direction of the inner tube (21), the connecting piece (22) is a wire harness, an annular cavity (212) which extends along the axial direction of the inner tube is formed in the inner tube (21), a plurality of through holes (213) which are used for connecting the annular cavity (212) with the outside are formed in the outer wall of the inner tube (21) along the axial direction of the inner tube, the second release mechanism (26) is a push rod (215) which is slidably arranged in the annular cavity (212) along the axial direction of the annular cavity (212), the push rod (215) extends along the axial direction of the annular cavity (212), a plurality of strip-shaped grooves (2151) are formed in the push rod (215) at intervals along the axial direction of the push rod, a cutting part (261) is arranged at the proximal end of the strip-shaped groove (2151), the cutting part (261) can cut off the connecting piece (22) when being contacted with the connecting piece (22), one end of the connecting piece (22) is fixedly connected with the push rod (215), the other end of the connecting piece (215) passes through a through hole (213) and then passes through a bulge bracket unit (11) and finally passes through the annular groove (2151) to pass through the same through the annular groove (213),
When the vascular stent system is in the assembled state, the through hole (213) through which the connecting piece (22) passes is far away from the bar-shaped groove (2151) and the through hole (213) is in the distal direction of the bar-shaped groove (2151), the part of the connecting piece (22) positioned in the bar-shaped groove (2151) is abutted against the distal end of the bar-shaped groove (2151),
When the vascular stent system is in the partially released state, the through hole (213) through which the connector (22) passes and the bar-shaped groove (2151) are close to and substantially aligned, and the connector (22) is located substantially in the middle of the bar-shaped groove (2151).
6. The vascular stent system according to claim 5, wherein the through holes (213) comprise a plurality of rows arranged at intervals along a circumferential direction of the inner tube (21), the connection member (22) comprises a plurality of rows arranged at intervals along a circumferential direction of the inner tube (21), the push rod (215) is tubular coaxially with the inner tube (21) and the bar-shaped groove (2151) comprises a plurality of rows arranged at intervals along a circumferential direction of the push rod (215).
7. The vascular stent system according to claim 6, wherein the self-expanding stent units (11) comprise a wave-shaped ring structure forming peaks (112) and valleys (111) in the circumferential direction, the peaks (112) and/or valleys (111) of each self-expanding stent unit (11) being respectively bound to the inner tube (21) by one of the connectors (22).
8. A vascular stent system, characterized by: the vascular stent system comprises:
the bracket component comprises a plurality of self-expanding bracket units (11) which are arranged along the axial direction and are mutually independent, wherein the self-expanding bracket units (11) are annular and have a radial expansion state and a radial compression state;
A delivery system, comprising:
The self-expanding stent comprises an inner tube (21), wherein a plurality of limiting parts (211) are fixedly arranged outside the inner tube (21), the limiting parts (211) are distributed at intervals along the axial direction of the inner tube (21), the self-expanding stent units (11) are sleeved on the inner tube (21), and one self-expanding stent unit (11) is arranged between two adjacent limiting parts (211);
-a connector (22) for movably connecting and binding each self-expanding stent unit (11) to the inner tube (21);
an outer sheath tube (23) which is relatively movably sleeved on the inner tube (21);
An operation handle (24) provided at the proximal ends of the outer sheath tube (23) and the inner tube (21);
A first release mechanism (25) provided between the operation handle (24) and the outer sheath tube (23) for driving the outer sheath tube (23) to slide in the axial direction of the inner tube (21) with respect to the inner tube (21);
a second release mechanism (26) provided on the operating handle (24) and/or the inner tube (21) for disconnecting each of the self-expanding stent units (11) and the inner tube (21),
The vascular stent system has an assembled state, a partially released state and a fully released state,
When the vascular stent system is in the assembled state, the self-expanding stent unit (11) is positioned between the inner tube (21) and the outer sheath tube (23) and is connected with the inner tube (21) through the connecting piece (22), the self-expanding stent unit (11) is in the radial compression state and has a movement tendency of being converted from the radial compression state to the radial expansion state,
When the vascular stent system is in the partially released state, the self-expanding stent unit (11) is positioned outside the inner tube (21) and the outer sheath (23) and still is connected and bound to the inner tube (21) by the connecting piece (22), the self-expanding stent unit (11) is in the radially expanded state,
When the vascular stent system is in the fully released state, the self-expanding stent unit (11) is located outside the inner tube (21) and the outer sheath (23) and disconnected from the inner tube (21), the self-expanding stent unit (11) is in the radially expanded state,
The connecting piece (22) comprises a plurality of wire harness rings which are arranged at intervals along the axial direction of the inner tube (21), the connecting piece (22) is a wire harness ring which is wound on the self-expanding bracket unit (11), an annular cavity (212) which extends along the axial direction of the inner tube (21) is formed in the inner tube (21), a plurality of through holes which are used for communicating the annular cavity (212) with the outside are formed on the outer wall of the inner tube (21) along the axial direction of the inner tube, the second release mechanism (26) comprises a push rod (215) which is slidably arranged in the annular cavity (212) along the axial direction of the annular cavity (212), the push rod (215) extends along the axial direction of the annular cavity (212), a plurality of deformable hooks (216) are arranged on the push rod (215) along the axial direction of the inner tube at intervals, the hooks (216) comprise an arm part and a hook part, one end of the arm part is rotatably connected with the inner tube (21) in a relative mode, the hook part is arranged on the other end of the arm part,
When the vascular stent system is in the assembled state, the hook (216) is positioned in the annular cavity (212), the part of the connecting piece (22) passes through a through hole (213) to be matched and connected with the hook part, the hook part of the hook (216) is positioned below the through hole (213),
When the vascular stent system is in the partial release state, the arm part of the hook (216) passes through the through hole (213) and is tensioned, the hook part is matched and connected with the connecting piece (22), the connecting part of the arm part and the inner tube (21) is positioned below the through hole (213),
When the vascular stent system is in the completely released state, the arm portion of the hook (216) passes through the through hole (213), the hook portion is separated from the connecting piece (22), and the connection position of the arm portion and the inner tube (21) is located in the distal direction of the through hole (213).
9. The vascular stent system according to claim 8, wherein the through holes (213) comprise a plurality of rows arranged at intervals along the circumferential direction of the inner tube (21), the self-expandable stent unit (11) comprises a wave-shaped ring structure forming peaks (112) and valleys (111) in the circumferential direction, the peaks (112) and/or valleys (111) of each self-expandable stent unit (11) are provided with one connecting piece (22), respectively, the push rod (215) is tubular coaxial with the inner tube (21) and the hooks (216) comprise a plurality of rows arranged at intervals along the circumferential direction of the push rod (215).
10. The vascular stent system according to claim 3 or 7 or 9, wherein the number of peaks (112) and valleys (111) of each self-expanding stent unit (11) is equal.
11. The vascular stent system according to claim 1,5 or 8, wherein the first release mechanism (25) comprises a rack (251) and a gear assembly which are arranged on the operating handle (24) and are connected in a matched manner, the distal end of the rack (251) is fixedly connected with the outer sheath tube (23), the operating handle (24) is fixedly connected with the proximal end of the inner tube (21), the gear assembly is rotatably arranged on the operating handle (24), and the gear assembly can drive the rack (251) to axially move along the axial direction when in operation.
12. The vascular stent system according to claim 1, 5 or 8, wherein the stent units are of equal or unequal diameters in the deployed state.
13. The vascular stent system according to claim 1 or 5 or 8, wherein the distal end of the inner tube (21) is provided with a guide portion which extends all the way out of the distal end of the outer sheath (23).
14. The vascular stent system according to claim 1 or 5 or 8, wherein each of the self-expanding stent units (11) is provided with a visualization mark, respectively;
And/or, the self-expanding bracket units (11) are made of nickel-titanium alloy.
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| CN202411124142.9A CN118649011B (en) | 2024-08-16 | 2024-08-16 | A vascular stent system |
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| CN202411124142.9A CN118649011B (en) | 2024-08-16 | 2024-08-16 | A vascular stent system |
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| CN118649011B true CN118649011B (en) | 2025-04-15 |
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| CN118649011A (en) | 2024-09-17 |
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