CN109431666B - Intraoperative stent delivery devices and intraoperative stent systems - Google Patents
Intraoperative stent delivery devices and intraoperative stent systems Download PDFInfo
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- CN109431666B CN109431666B CN201811654752.4A CN201811654752A CN109431666B CN 109431666 B CN109431666 B CN 109431666B CN 201811654752 A CN201811654752 A CN 201811654752A CN 109431666 B CN109431666 B CN 109431666B
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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
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
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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
- 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
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- 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)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Abstract
本发明涉及医疗器械领域，提供了一种术中支架输送装置和一种术中支架系统。所述术中支架输送装置用于组装和释放分支型术中支架，分支型术中支架包括主体支架和侧支支架，术中支架输送装置包括用于支撑主体支架的侧支内衬和用于支撑侧支支架的侧支内衬、用于束缚侧支支架的软膜以及回撤件，侧支内衬为贯通结构，回撤件在侧支内衬内可移动，软膜在侧支内衬的远端集中后与回撤件的远端连接。其中，软膜还可以作为分支阻断部件防止目标位置的分支血管返流，保证支架手术范围内的视野清晰，方便医生操作，阻断过程不需要单独分步操作，缩短手术时间，提高手术的成功率和术后效果。所述术中支架系统包括上述术中支架输送装置。
The present invention relates to the field of medical devices, and provides an intraoperative stent delivery device and an intraoperative stent system. The intraoperative stent delivery device is used to assemble and release a branch-type intraoperative stent, which includes a main stent and a side branch stent. The intraoperative stent delivery device includes a side branch liner for supporting the main stent and a side branch liner for supporting the side branch stent, a soft membrane for restraining the side branch stent, and a retraction member. The side branch liner is a through structure, and the retraction member is movable in the side branch liner. The soft membrane is connected to the distal end of the retraction member after being concentrated at the distal end of the side branch liner. Among them, the soft membrane can also be used as a branch blocking component to prevent the backflow of branch blood vessels at the target position, ensure a clear field of vision within the stent operation range, facilitate the doctor's operation, and the blocking process does not require separate step-by-step operations, shortening the operation time, and improving the success rate of the operation and the postoperative effect. The intraoperative stent system includes the above-mentioned intraoperative stent delivery device.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an intraoperative stent delivery device and an intraoperative stent system comprising the intraoperative stent delivery device.
Background
In recent years, a method of implanting a stent used by an endoluminal isolation technique to a diseased site of an aorta under a surgical condition has been widely used in many lesions of the thoracic aorta, abdominal aorta, iliac vessels, etc. due to a small wound and a high success rate. Where the stent is surgically implanted to the corresponding lesion site, such stents are often referred to as intraoperative stents. The stent can be implanted to the corresponding lesion position by means of the delivery device, namely, the diameter of the stent is reduced by the delivery device, the stent is released after being delivered to the corresponding lesion position, if necessary, the stent is sutured with the artificial blood vessel, and finally, the delivery device is withdrawn. However, due to the complexity of the anatomy of the aortic portion, current delivery devices still present significant problems in delivering intraoperative stents.
Taking aortic lesions as an example, aortic aneurysms or dissection often widely involve the ascending aorta, aortic arch and descending aorta, surgical excision and vascular reconstruction are quite complex, and common treatment methods are to replace the diseased vessels of the ascending and arch parts of the human body by surgical implantation. The traditional trunk (ET) operation is performed by inserting a section of artificial blood vessel (commonly called nose) into the vacuum cavity of the descending aorta while performing aortic arch replacement operation, so as to reduce the difficulty of distal re-operation, and is usually completed in two stages. The traditional trunk operation can generate brain and spinal cord injury, embolism, blood circulation disorder, bleeding and other related complications due to extracorporeal circulation and cryogenic stop circulation.
At present, a bracket trunk operation is often adopted clinically, and the structural principle of the bracket trunk operation is shown in figure 1. Wherein, the artificial blood vessel 110 is connected with the intraoperative stent 130 through the suture port 120, the intraoperative stent 130 is implanted into the descending aorta 10 and released by the conveying device under the direct view of the primary operation, the proximal empty membrane section of the intraoperative stent 130 is released, and the distal end of the artificial blood vessel 110 is anastomosed with the aortic wall or the blood vessel of the replacement bow. The trunk operation combines the trunk principle and the concept of intervention of the trunk blood vessel, can be completed through the sternum median incision, and has the advantages of being anchored at a specific level of the descending aortic aneurysm wall, promoting thrombosis between the trunk blood vessel and the aneurysm wall, avoiding secondary operation possibly performed due to advanced aneurysm or rupture of the descending aortic artery, simplifying operation and reducing complications compared with the traditional trunk operation.
The intraoperative stent shown in fig. 1 is a straight-tube type stent, which has the problem that the stent is difficult to be completely matched with the branches of blood vessels of a human body, so that the stent is usually implanted in the branch type intraoperative stent at present, when the branch type intraoperative stent and an artificial blood vessel are adopted for aortic lesion surgery, the branch blood vessels of the upper head arm of an arch are required to be dissociated, blocked, anastomosed and the like, and a plurality of important tissue structures including trachea, esophagus, nerves, chest catheters and the like are arranged around the aortic arch, so that the technology requirements for the dissociation of the blood vessels of the head arm are very high, and the difficulty of the branch blood vessels on the free arch is increased. In the prior art (such as CN 104873305A), it is proposed to block the aortic vessel and the branch vessel on the aortic arch by adding a flexible sheet or inflatable balloon at the junction of the branch stent graft and the main body vessel or in the lumen of the branch stent graft. However, the blocking device using the flexible sheet needs to pass the release line from the outer side of the artificial blood vessel cavity of the main body along the inner hole of the double-folded suture line, and the release line is easy to cause when released, so that the side branch stent is tightened to cause torsional deformation of the side branch stent, and the occlusion is caused for a long time. And by using the plugging device capable of filling the balloon, the whole section of the side branch stent is increased, and the balloon is required to be filled and sucked back, so that the operation time is increased. Therefore, when the aortic lesion operation is performed by using the intraoperative stent, how to make the visual field of the suture position of the branch stent and the artificial blood vessel clear after the branch stent is placed, reduce the operation difficulty and the operation time, so as to improve the success rate and the postoperative effect of the operation, and the method is still an important problem to be solved in the field.
Disclosure of Invention
In order to make the suture part of the main body stent and the artificial blood vessel after the stent is placed in the open chest operation treatment clear in view, reduce the operation difficulty and the operation time, increase the success rate and the postoperative effect of the aortic lesion operation, the invention provides an intraoperative stent conveying device and an intraoperative stent system.
According to one aspect of the present invention, there is provided an intraoperative stent delivery device for delivering and releasing a branched intraoperative stent comprising a main body stent and a side branch stent, the intraoperative stent delivery device comprising a main body liner for supporting the main body stent and a side branch liner for supporting the side branch stent, a flexible membrane for binding the side branch stent, and a withdrawal member, the side branch liner being of a hollow structure, the withdrawal member being movable within the side branch liner, the flexible membrane being connected to a distal end of the withdrawal member after a distal end of the side branch liner is tightened.
Optionally, the proximal aperture of the side branch liner is smaller than the distal aperture.
Optionally, the retraction member comprises a retraction guidewire.
Optionally, the proximal aperture of the side branch liner is greater than the diameter of the withdrawal guide wire and less than or equal to twice the diameter of the withdrawal guide wire.
Optionally, the intraoperative stent conveying device further comprises a control end and a supporting rod connected with the control end, the main lining is connected with the distal end of the supporting rod, the side branch lining is arranged on the supporting rod, and the supporting rod is of a hollow tubular structure.
Optionally, the intraoperative stent delivery device further comprises a retraction track, wherein the retraction track penetrates through the support rod and the communicated interior of the side branch lining, and is arranged between the control end and the distal end of the side branch lining.
Optionally, the control end includes a first wire puller, and the proximal end of the withdrawal member is connected to the first wire puller.
Optionally, the control end further comprises a second wire puller for releasing the main body support.
Optionally, the control end further comprises a handle and a sliding block arranged on the handle in a sliding manner, wherein the sliding block is connected with the side branch lining so as to control the angle between the side branch lining and the supporting rod.
Optionally, the material of the side branch lining comprises at least one of soft silica gel, rubber, nylon elastomer, low density polyethylene, polyester, ultra-high molecular polyethylene, stainless steel and nickel titanium, and the material of the soft film comprises at least one of terylene, polytetrafluoroethylene and derivatives thereof, polyethylene terephthalate and derivatives thereof.
According to another aspect of the present invention, there is also provided an intraoperative stent system comprising a branched intraoperative stent and the aforementioned intraoperative stent delivery device, the branched intraoperative stent comprising a main body stent and a side branch stent, the main body stent being sleeved outside a main body liner of the delivery device, the side branch stent being sleeved outside a side branch liner of the intraoperative stent delivery device, the side branch stent being constrained within a soft membrane of the intraoperative stent delivery device before release.
Optionally, the branched intraoperative stent further comprises an artificial blood vessel connected and communicated with the proximal end of the main body stent.
The intraoperative stent conveying device is used for conveying and releasing branch type intraoperative stents, in particular to a side branch stent, and comprises a side branch lining used for supporting the side branch stent, a soft film used for binding the side branch stent and a withdrawing piece, wherein the side branch lining is of a hollow structure, the withdrawing piece is movable in the side branch lining, and the soft film is connected with the distal end of the withdrawing piece after the distal end of the side branch lining is tightened. The intraoperative stent delivery device has the following advantages:
Firstly, a retracting piece is arranged on a conveying device, one side of the far end of a side branch lining is connected with a soft film used for binding the side branch stent, after the side branch stent is conveyed to a target position, the near end of the side branch stent is released first, the soft film covers the far end of the side branch lining and the side branch stent which is partially released, so that the soft film can also be used as a branch blocking component to prevent branch blood vessels at the target position from flowing back, the visual field in the operation range of the stent is ensured to be clear, a doctor can conveniently perform operations such as releasing a main body stent, suturing an artificial blood vessel and the like, the operation time is shortened, and the success rate and the postoperative effect of the operation are improved.
And secondly, the withdrawing piece and the soft membrane are used as a part of the intraoperative stent conveying device, the functions of blocking and conducting the branch blood vessel at the target position can be utilized according to the needs in the processes of releasing the branch intraoperative stent and withdrawing the intraoperative stent conveying device, the blocking process does not need separate step operation, the operation is convenient, and the surgical time is shortened.
And thirdly, the side branch stent is gradually released from the proximal end to the distal end through the linkage of the retracting piece and the soft membrane, and the releasing mode can prevent the side branch stent from shrinking and avoid the stenosis or even occlusion of the long-term stent.
The intraoperative stent system provided by the invention comprises a branched intraoperative stent and the intraoperative stent conveying device, and has the same or similar advantages as the intraoperative stent conveying device.
Drawings
Fig. 1 is a schematic structural diagram of a stent trunk surgery.
Fig. 2 is a schematic view of a branched intraoperative stent.
Fig. 3 is a schematic view of an intraoperative stent delivery device according to an embodiment of the present invention.
Fig. 4 is an enlarged schematic view of a side branch liner in an intraoperative stent delivery device in accordance with one embodiment of the present invention.
FIG. 5 is a schematic view of a side branch liner utilizing an embodiment of the present invention in a tightened state after assembly of the side branch stent.
Fig. 6 is a schematic view of a blocking a branch vessel using an intraoperative stent delivery device in accordance with one embodiment of the present invention.
Fig. 7 is a schematic view of an intraoperative stent system in accordance with one embodiment of the present invention.
Fig. 8 is a schematic view of a release branch stent using an intraoperative stent system in accordance with one embodiment of the present invention.
Fig. 9 is a schematic view of suturing a vascular prosthesis using an intraoperative stent system in accordance with one embodiment of the present invention.
Reference numerals illustrate:
110. 210-vascular prosthesis, 120, 220-suture, 130-intraoperative stent, 200-branch intraoperative stent, 230-main body stent, 240-side branch stent, 10-descending aorta;
300-intraoperative stent delivery device, 310-side branch lining, 320-soft membrane, 330-withdrawal piece, 20-connection point of withdrawal piece and soft membrane, 331-withdrawal track, 340-main body lining, 341-main body guide head, 342-guide wire hole, 350-control end, 351-handle, 352-slide block, 353-first wire puller, 354-second wire puller, 360-support rod and 400-intraoperative stent system.
Detailed Description
The intraoperative stent delivery device and the intraoperative stent system of the present invention are described in further detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely to facilitate a convenient and clear description of embodiments of the invention.
Fig. 2 is a schematic view of a branched intraoperative stent. Referring to fig. 2, the branched intraoperative stent 200 includes a main body stent 230 and a side branch stent 240, and the main body stent 230 is sutured to the artificial blood vessel 210 through a suture port 220. Taking aortic arch replacement operation as an example, the main body stent 230 needs to be implanted into the descending aorta 10, the side branch stent 240 is implanted into the left subclavian artery, and because the left subclavian artery is deeper, free dissection and suture are difficult, the operation difficulty is high, free dissection and left subclavian artery suture time in operation can be avoided by increasing the side branch stent 240, the operation difficulty is reduced, the operation time is reduced, and the damage degree of free tissues to surrounding tissues is reduced.
In order to further solve the problems of high branch vessel free difficulty, long operation time and the like in the operation by utilizing the branch type intraoperative stent, the invention provides an intraoperative stent conveying device and an intraoperative stent system comprising the same, and aims to set a component with a branch blocking function in the conveying device of the branch type intraoperative stent, prevent the branch vessel from flowing back in the processes of releasing the branch type intraoperative stent and withdrawing the intraoperative stent conveying device, ensure clear view in the operating range of the stent, facilitate the operation of doctors, shorten the operation time and improve the success rate and the postoperative effect of the operation.
Fig. 3 is a schematic view of an intraoperative stent delivery device according to an embodiment of the present invention. Fig. 4 is an enlarged schematic view of a side branch liner in an intraoperative stent delivery device in accordance with one embodiment of the present invention. Referring to fig. 2 to 4, in an embodiment of the present invention, an intraoperative stent delivery apparatus 300 is used to deliver and release a branched intraoperative stent 200, the branched intraoperative stent 200 includes a main body stent 230 and a side branch stent 240, the intraoperative stent delivery apparatus 300 includes a side branch liner 310 for supporting the side branch stent 240, a flexible membrane 320 for binding the side branch stent 240, and a withdrawing member 330, the side branch liner 310 is of a hollow structure, the withdrawing member 330 is movable within the side branch liner 310, and the flexible membrane 320 is connected with a distal end of the withdrawing member 330 after a distal end of the side branch liner 310 is tightened.
Hereinafter, the end of the branched intraoperative stent 200 facing the implanted descending aorta is taken as a distal end, the end far away from the implanted descending aorta is taken as a proximal end, and correspondingly, the joint of the side branch stent 240 and the main body stent 230 is taken as a proximal end of the side branch lining 310, and conversely, is taken as a distal end of the side branch lining 310. That is, in fig. 3, the end proximal to the delivery device body is the proximal end of the side branch liner 310 and the end distal to the delivery device body is the distal end of the side branch liner 310.
The above-mentioned intraoperative stent delivery device 300 may further include a main body liner 340, the main body liner 340 is used for supporting the main body stent 230, a main body guide head 341 and a guide wire hole 342 are provided at the distal end of the main body liner 340, the main body guide head 341 is used as the distal end of the intraoperative stent delivery device 300, the surface is streamline, so as to facilitate the delivery of the branched intraoperative stent 200, during the process of delivering the main body stent 230 to the target position, one end of a main body guide wire (not shown) penetrates into the true lumen of the diseased aorta (for example, the descending aorta), the other end penetrates into the guide wire hole 342, and then the intraoperative stent delivery device 300 is wholly passed through the true lumen of the diseased aorta (for example, the descending aorta) along the main body guide wire, and the main body stent 230 is implanted into the true lumen of the diseased aorta. The main body guide head 341 may be made of a polymer material with good biocompatibility, such as a low density polyethylene (LDFE) material, a nylon elastomer (Pebax) material, or other polymer materials with the same properties.
When the branch type intraoperative stent 200 is delivered by the intraoperative stent delivery device 300, the main body lining 340 is inserted into the main body stent 230, the side branch lining 310 is inserted into the side branch stent 240, or the main body stent 230 is sleeved outside the main body lining 340, and the side branch stent 240 is sleeved outside the side branch lining 310. Typically, the external portion of the branch stent 200 is provided with a constraining member for attaching the stent to the outer surfaces of the main body liner 340 and the side branch liner 310 under the action of compressive force, so that the branch stent 200 is delivered to a target site by means of the intra-operative stent delivery device 300, for example, the main body stent 230 is delivered into the lumen of the descending aorta 10, the side branch stent 240 is delivered into the left subclavian artery, and then the compressive force of the constraining member to the main body stent 230 and the side branch stent 240 is released at the target site, thereby releasing the branch stent 200 at the target site.
With continued reference to fig. 2 and 3, in this embodiment, the intraoperative stent delivery device 300 further includes a control end 350 and a support rod 360 connected to the control end 350, and the side branch liner 310 is disposed outside the support rod 360. The body liner 340 is preferably flexible to facilitate adjusting the relative position and angle of the body liner 340 and the side branch liner 310 of the intraoperative stent delivery device 300 and to match the configuration of the target site for release of the branched intraoperative stent 200. The support rod 360 may be a tubular structure to facilitate the attachment of the control end 350 to the body liner 340, the side branch liner 310, the body support 230, and the side branch support 240. In some embodiments, the support rod 360 is a hollow tubular structure.
The control end 350 is controlled by the operator to control the position of the side branch liner 310, and the operator can control the release of the branched intra-operative stent 200 through the control end 350 after delivering the branched intra-operative stent 200 to the target site. As shown in fig. 3, in the intraoperative stent delivery device 300 of the present embodiment, the control end 350 includes a handle 351, and the handle 351 may be designed to be convenient for an operator to grasp and may be in communication with the inside of the support rod 360, the main body liner 340 and the side branch liner 310 to provide specific control means for performing operations related to implantation of the branched intraoperative stent 200, such as installation, transmission, release, etc.
Illustratively, to control the angle between the side branch liner 310 and the support rod 360, a slider 352 is slidably disposed on the handle 351, and the angle between the side branch liner 310 and the body liner 340 (or the support rod) may be adjusted by sliding the slider 352 in a sliding groove on the handle 351. The slider 352 and the side branch liner 310 may be connected by, for example, a linkage mechanism.
Referring to fig. 4, in the present embodiment, the stent delivery device 300 binds the side branch stent 240 by using the flexible membrane 320, and when delivering the branched type stent 200, the flexible membrane 320 is located outside the side branch liner 310 to cover the side branch stent 240. The material of the flexible film 320 may include at least one of polyester, polytetrafluoroethylene (PTFE) and its derivatives, polyethylene terephthalate (PET) and its derivatives, and in this embodiment, the material of the flexible film is expanded polytetrafluoroethylene (expanded PTFE). After the branch stent 200 is delivered to the target site, the side branch stent 240 may be released into the corresponding vessel by releasing the constraint of the flexible membrane 320 on the covered side branch stent 240. It should be noted that, in this embodiment, the problem of how to prevent the branch vessel from flowing back, facilitate the operation of the doctor, and shorten the operation time is mainly described in the process of delivering and releasing the branch type intraoperative stent by using the intraoperative stent delivery device of the present invention, but the soft membrane may be disposed in other areas to realize other corresponding functions. For example, in another embodiment, another flexible membrane may be provided on the exterior of the body liner 340 to encase the body support 230. The soft membrane cladding branch type intraoperative stent is utilized for conveying, so that the smoothness of the whole stent can be increased, the blood vessel is prevented from being scratched, and the stent is convenient to push.
FIG. 5 is a schematic view of a side branch liner utilizing an embodiment of the present invention in a tightened state after assembly of the side branch stent. Referring to fig. 3 to 5, in the present embodiment, the side branch liner 310 is of a hollow structure, where hollow means that the side branch liner 310 as a whole is penetratable, for example, can be penetrated from a distal end (proximal end) of the side branch liner 310 into the side branch liner 310 and penetrated from a proximal end (distal end), so that the connection point 20 of the retracting member 330 and the flexible membrane 320 can be led out from the proximal end of the side branch liner 310, and further connected with the control end 350, for example, so that the movement of the retracting member 330 within the side branch liner 310 (for example, the movement of the retracting member 330 between the distal end and the proximal end of the side branch liner 310 as needed) can be controlled by the control end 350. Hereinafter, the front end portion of the withdrawing member 330 when moving toward the distal end of the side branch liner 310 is referred to as the distal end of the withdrawing member 330, and the end portion of the withdrawing member 330 opposite to the distal end (or the end near the control end) is referred to as the proximal end of the withdrawing member 330.
Illustratively, prior to assembly of the side branch stent 240 described above, the flexible membrane 320 is disposed outside the side branch liner 310 to bind the side branch stent 240 assembled outside the side branch liner 310. In this embodiment, the flexible membrane 320 is attached to the distal end of the withdrawal element 330 after the distal end of the side branch liner 310 is tightened (e.g., withdrawn without a gap). The retractor 330 is positioned inside the side branch liner 310 and is movable within the side branch liner 310. When the retracting member 330 is moved in a distal direction away from the side branch liner 310, the flexible membrane 320 is driven into the side branch liner 310, and at the same time, a portion of the flexible membrane 320 near the proximal side of the side branch liner 310 is moved toward the distal end of the side branch liner 310, so that the side branch stent 240 can be gradually released from the proximal end to the distal end by the movement of the retracting member 330. The release mode from the near to the far can prevent the side branch stent from shrinking and avoid the stenosis and even occlusion of the long-term stent.
The delivery and release of the branched intra-operative stent 200 to the target site using the intra-operative stent delivery apparatus 300 described above may be accomplished under the control of the control end 350. In particular, the control end 350 may include a first wire puller 353, for example, disposed at an end of the handle 351 remote from the support rod 360, the first wire puller 353 may be coupled to the proximal end of the retractor 330 through the handle 351 such that movement of the retractor 330 within the side branch liner 310 may be inhibited by pulling the first wire puller 353. Accordingly, the control end 350 may further include a second wire stretcher 354 for releasing the main body support 230, where the second wire stretcher 354 may also be disposed at an end of the handle 351 away from the support rod 360, and the second wire stretcher 354 may specifically be a detachable component disposed at a side of the handle 351 away from the support rod 360, where the distal end of the second wire stretcher 354 facing the main body liner 340 is connected to a constraining component for constraining the main body support 230 outside the main body liner 340, and when the second wire stretcher 354 (or the detachable component) moves in a direction away from the handle 351, the constraining component releases the constraint on the main body support 230 to release the main body support 230.
The intra-operative stent delivery device 300 of this embodiment can not only complete the release of the branch-type intra-operative stent 200 by using the above-mentioned linkage of the retracting member 330 and the flexible membrane 320, but also block the blood flow of the branch vessel by using the flexible membrane 320 as a branch blocking member according to the operation requirement, thereby preventing the intra-operative reflux. Fig. 6 is a schematic view of a blocking a branch vessel using an intraoperative stent delivery device in accordance with one embodiment of the present invention. Referring to Figs. 2 to 6, after the branch stent 200 is delivered to the target site, the method of blocking the blood flow of the branch vessel at the target site using the above-mentioned flexible membrane 320 as a branch blocking member is such that when the distal end of the withdrawal member 330 is moved in a direction away from the distal end of the side branch liner 310, the portion of the flexible membrane 320 located on the proximal end side of the side branch liner 310 is moved a distance toward the distal end of the side branch liner 310 (or the side branch stent 240), at which time only the proximal end of the side branch stent 240 is released, the flexible membrane 320 is partially opened by the released side branch stent 240 and covers the distal end of the side branch liner 310 and the side branch stent 240 (continuously covers the surface of the side branch stent 240 toward the distal end of the side branch liner 310), thereby having the effect of blocking the blood flow of the branch vessel at the target site, thereby achieving the effect of preventing reflux.
When the above blocking method is used to block the blood flow of the branch vessel at the target position during the release process of the side branch stent 240, in order to prevent the flexible membrane 320 from moving away from the side branch liner 310 along with the movement of the retracting member 330 and improve the blocking effect of the flexible membrane 320, in this embodiment, the proximal aperture of the side branch liner 310 is preferably smaller than the distal aperture thereof, and specifically, the side branch liner 310 may have a horn-shaped structure or a structure surrounded by a frustum and a pyramid, but not limited thereto, the side branch liner 310 may have other regular or irregular shapes, for example, the side branch liner 310 may also include a wavy surface. The material of the side branch lining 310 may include any one of soft silica gel, rubber, nylon elastomer, low density polyethylene, polyester, ultra high molecular polyethylene, and other high molecular materials, and may also include any one of metal materials such as stainless steel, nickel titanium, and the like, and the material of the main body lining 340 may be selected to be the same as the material of the side branch lining 310. It will be appreciated that the intraoperative stent delivery device 300 is preferably made of a biocompatible material.
In this embodiment, the retraction member 330 is connected to the flexible membrane 320 at its distal end, so that the gradual release of the side stent 240 can be achieved while pulling on the retraction of the flexible membrane 320, while simultaneously blocking the vascular reflux at the target site as required by the procedure. The flexible membrane 320 may be connected between the concentrated portion of the distal end of the side branch liner 310 and the distal end of the retracting member 330 disposed in the side branch liner 310 by means of binding, clamping, or the like, or an intermediate connecting member may be disposed therebetween to connect them. For example, the portion of the flexible membrane 320 on the distal side of the side branch liner 310 may be attached to the distal end of the withdrawal element 330 by tightening.
The retractor 330 may include a retractor guide wire, a connecting wire, etc., and may include other transmission or linkage components, for example, the retractor 330 may also include pulleys, gears, and belts. In this embodiment, the retractor 330 comprises a retractor guidewire having a diameter and length that may be specifically selected based on the use and overall construction of the intraoperative stent delivery device 300. Specifically, the distal end of the withdrawal guide wire may be connected to the flexible membrane 320, while the proximal end of the withdrawal guide wire preferably extends outside the side branch liner 310, through the support rod 360 to the control end 350, so that an operator can control the movement of the distal end of the withdrawal guide wire within the side branch liner 310 via the control end 350. In order to facilitate the recovery of the flexible membrane 320 by retracting the guide wire without removing the side branch liner 310, preferably, the portion of the side branch liner 310 near the proximal end of the support rod 360 is thin enough to easily pass through the retracting guide wire. Optionally, the proximal aperture of the side branch liner 310 is greater than one diameter of the pull-back guidewire and less than or equal to two diameters of the pull-back guidewire.
The intraoperative stent delivery apparatus 300 of the present embodiment may further include a retraction track 331 for moving the retraction member 330, wherein the retraction track 331 penetrates the support rod 360 and the inside of the communication of the side branch liner 310 and is disposed between the control end 350 and the distal end of the side branch liner 310, so as to limit the movement range of the retraction member 330 and improve the operation accuracy. For example, with a withdrawal guide wire as the withdrawal element 330, the withdrawal guide wire may be moved along the withdrawal track 331 within the side branch liner 310 and between the proximal end of the side branch liner 310 and the control end 350. For the portion of the side branch liner 310 between the proximal end and the control end 350, a retraction track 331 may be provided inside the tubular structure of the support rod 360.
The assembly and release of the branched stent 200 by using the above-mentioned stent delivery device 300 has the advantages that firstly, the withdrawing member 330 is disposed on the stent delivery device 300 and connected to the flexible membrane 320 for constraining the side stent 240 at the distal end side of the side stent liner 310, after the side stent 240 is delivered to the target site, the proximal end of the side stent 240 is released first, the flexible membrane 320 is covered on the distal end of the side stent liner 310 and the partially released side stent 240, so that the flexible membrane 320 can also serve as a branch blocking member to prevent the reflux of the branched vessel at the target site, ensuring the clear view in the stent operation range, facilitating the operation such as suturing the artificial vessel 210 (see fig. 2), shortening the operation time, improving the success rate and the postoperative effect of the operation, and secondly, the withdrawing member 330 and the flexible membrane 320 serve as a part of the stent delivery device 300, the function of blocking and conducting the branched vessel at the target site can be utilized step by step according to the need in the process of releasing the branched stent 200 and the in the process of the branched stent delivery device, the separate operation is not convenient for the side stent 320 to be released from the distal end of the side stent 240, and the side stent 240 can be prevented from being gradually shortened by the operation time, and the side stent is prevented from being released by the side stent 240.
This embodiment also includes an intraoperative stent system comprising the intraoperative stent delivery device 300 described above and a branched intraoperative stent 200. Fig. 7 is a schematic view of an intraoperative stent system in accordance with one embodiment of the present invention. Referring to fig. 2 to 7, in the intraoperative stent system 400 of the present embodiment, the branched intraoperative stent 200 includes a side branch stent 240, the side branch stent 240 is sleeved outside the side branch liner 310 of the intraoperative stent delivery device 300, and the side branch stent 240 is constrained in the flexible membrane 320 of the intraoperative stent delivery device 300 before being released. Typically, the branched intraoperative stent 200 further comprises a main body stent 230 and an artificial blood vessel 210 connected to and communicating with the proximal end of the main body stent 230, the artificial blood vessel 210 being configured to fit over the main body liner 340.
The branched intraoperative stent 200 may be a stent graft, specifically, the main stent 230 may include a main stent body and a main stent graft (not shown) covered on the main stent body, the side stent 240 may include a side stent body and a side stent graft (not shown) covered on the side stent graft, and the soft membrane 320 in this embodiment may cover the outer surface of the side stent graft when assembled, and in another embodiment, the outer surface of the main stent graft may also cover another soft membrane.
Taking aortic arch replacement surgery as an example, the delivery of the above-described stent system 400 to a target site, the release of the branched intra-operative stent 200 therein, and the withdrawal of the intra-operative stent delivery device 300 using the intra-operative stent delivery device 300 of the present embodiment may include the following procedures:
Firstly, evaluating the bending states of an aortic arch and a descending aorta before operation, and adjusting the main body lining 340 according to the bending degree of the descending aorta to enable the main body lining 340 to form an angle so as to obtain corresponding matching bending degree;
then, the left subclavian artery position is observed after incision through the ascending aorta or aortic arch, and the angle between the side branch stent 240 and the main body stent 230 is adjusted by moving the slider 352 on the handle 351 back and forth;
Next, the intraoperative stent system 400 is delivered to the target site (or lesion), more specifically, referring to fig. 3-7, one end of the main body guidewire is threaded into a guidewire hole 342 in a main body guidewire 341, the intraoperative stent system 400 is delivered along the main body guidewire to the target site (here, for example, in the descending aortic lumen), and the side branch stent 240 is positioned into a branch vessel (here, for example, in the left subclavian artery);
Then, the release of the branch-type intraoperative stent 200 is started in the order of proximal ends of the main body stent 230, the artificial blood vessel 210 and the side branch stent 240, more specifically, referring to fig. 3,5 and 8, the main body stent 230 and the artificial blood vessel 210 are released by the second wire puller 354, and then the retraction guide wire of the retraction member 330 is pulled by the first wire puller 353 to move from a direction away from the distal end of the side branch liner 310, so that the pulling of the first wire puller 353 is suspended after the proximal end of the side branch stent 240 is released;
Next, the side branch lining 310, the retracting guide wire and the retracting track 331 are kept still, and the other parts of the conveying device are retracted, wherein the branch blood vessel for placing the side branch stent 240 is blocked by the soft membrane 320 and is in a blocking state, and no blood flows back as shown in fig. 6;
then, the four-branch artificial blood vessel or the artificial blood vessel with other shape (namely, the artificial blood vessel 210) is sleeved on the outer ring of the retracting guide wire of the retracting member 330, then end-to-end anastomosis (or suture) is carried out on the artificial blood vessel at the proximal end of the autologous blood vessel and the main body stent 230, at the moment, the suture of the artificial blood vessel and the ascending aorta is completed, and the suture is stopped after the suture is carried out to a 3-5 needle distance from the starting point, as shown in fig. 9;
Next, the side branch stent 240 is fixed, the soft membrane 320 is withdrawn into the side branch lining 310 from the distal end through the withdrawing guide wire, and the side branch stent 240 is released from the proximal end to the distal end;
Finally, the side branch lining 310 is withdrawn together with the whole intraoperative stent delivery device 300, and the surgical suture portion is ended after the 3-5 needle suture of the remaining artificial blood vessel is completed. Through implantation of the stent and the artificial blood vessel, a new blood flow channel is formed at the lesion part, more specifically, a tumor cavity can be isolated outside a blood circulation system, so that the blood pressure of the hemangioma wall is not born any more, the tumor body is prevented from being broken, and the treatment purpose is achieved.
The intraoperative stent system 400 of this embodiment includes the intraoperative stent delivery device 300 described above, and in the assembly, implantation, and release processes of the branch-type intraoperative stent 200, the peripheral region (or stent operation region) where the branch-type stent 200 is placed can be made clear in view, the suction time can be reduced, the suture effect can be improved, and the suture time can be reduced, so that the treatment of the thoracotomy can be facilitated, the operation time can be reduced, the operation difficulty can be reduced, and the success rate and the postoperative effect of the thoracotomy can be improved.
In this embodiment, the description is performed in a progressive manner, and the following structural emphasis description is merely to refer to the differences from the previous structure.
The foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the claims, and any person skilled in the art may make any possible variations and modifications to the technical solution of the present invention using the method and technical content disclosed above without departing from the spirit and scope of the invention, so any simple modification, equivalent variation and modification made to the above embodiments according to the technical matter of the present invention fall within the scope of the technical solution of the present invention.
Claims (9)
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| CN102166143B (en) * | 2011-05-23 | 2014-04-09 | 先健科技(深圳)有限公司 | Device for conveying bracket in operation |
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| US9955971B2 (en) * | 2015-12-30 | 2018-05-01 | Lifetech Scientific (Shenzhen) Co. Ltd. | Method for treating aortic arch diseases |
| CN108309507A (en) * | 2018-02-14 | 2018-07-24 | 朱效华 | A kind of compound arch of aorta reconstructing system and its application method |
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| CN2762776Y (en) * | 2004-12-30 | 2006-03-08 | 深圳市先健科技股份有限公司 | Reversely-released aorta coated stand transfer system |
| CN106618822A (en) * | 2016-12-26 | 2017-05-10 | 微创心脉医疗科技（上海）有限公司 | Intraoperative support conveying system and intraoperative support system |
| CN209678769U (en) * | 2018-12-28 | 2019-11-26 | 上海微创心脉医疗科技股份有限公司 | Support system in stent conveying device and art in art |
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