• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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  • 法律状态
  • 优先权
    • 专利摘要:
    GUIDING CATHETER AND BRANCHED STENT GRAFT IMPLANTATION SYSTEM. The present invention deals with a guide catheter (8, 8') for a branched stent graft implant system and the branched stent graft implant system, the guide catheter (8, 8') being used for the introduction of the guide wires (5 , 6, 7) in the corresponding cavities of a branched blood vessel, so that the stent branches (10, 11, 12) of a branched stent (9) are subsequently drawn into their corresponding branched blood vessel cavities, which the guide catheter (8, 8') characterized in that it is provided with at least one axially extending guide wire channel to guide the guide wires (5, 6, 7), of which each of the guide wire channels is provided with an inlet (a, b, c) and a corresponding outlet (d, e, f) for the guide wires, and that the guide catheter (8, 8') is axially divided between the inlet for the guide wire ( a, b, c) and the guidewire outlet (d, e, f) of the respective guidewire channels to form incisions (30, 100, 100', 100"), through d which the respective guide wires (5, 6, 7) can be detached from the guide catheter (8, 8').
    公开号:BR112014017341B1
    申请号:R112014017341-9
    申请日:2013-01-10
    公开日:2021-05-04
    发明作者:Qing Zhu；Dingguo Huang；Qiyi Luo；Yanbin Gao
    申请人:Microport Endovascular (Shanghai) Co., Ltd；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [0001] The invention is related to a medical instrument, in particular a guide catheter of a branched stent implant system that is useful for the surgical treatment of aortic lesions. The invention further relates to a branched stent graft implant system comprising such a guide catheter. HISTORIC
    [0002] In clinical practice, a substantial part of aortic aneurysms involve a number of branched aortic arteries. In traditional treatment, for patients suffering from a Stanford Type A aortic dissection, that is, an entire aortic lesion (including the ascending aorta, aortic arch, descending aorta, and abdominal aorta), an operation is usually performed. of median thoracotomy, in which an artificial blood vessel is used in place of the arch of the ascending aorta, and an artificial blood vessel prosthesis (commonly known as an elephant's trunk) is inserted into the true lumen of the descending aorta to prepare for a second operation or a second interventional treatment (Covered Endoprosthesis Implantation). For most patients, treatment cannot be completed in a single operation, and the second operation requires a thoracotomy under the left ribs. The second operation has a high risk, a high cost, and it is a little difficult to connect the operations. Such traditional prosthetic blood vessel replacement is extremely complex, causes a very large wound, and the mortality rate is extremely high. Thus, it is necessary to carry out the treatment using a minimally invasive surgical method.
    [0003] An intraoperative endoprosthesis has been developed in recent years and can effectively solve the above problem which occurs due to the second operation, ie the entire treatment can be completed in a single operation. In operation, a covered endoprosthesis is implanted directly into the true lumen of the descending aorta, which cannot be exposed through the aorta that has been cut open, thus achieving the goal of treatment. The intraoperative stent graft cover material can be sutured with the artificial blood vessel used in the operation, thus obtaining a complete artificial vascular graft replacement system and achieving the goal of completing the entire treatment in a single operation. Adopting an intraoperative stent graft to perform the operation not only completes the entire treatment in a single operation, but also shortens the operation time and alleviates the pain suffered by a patient due to the second operation.
    [0004] Chinese patent application CN101332133A describes an interlacing device for a branched stent graft or implant and a manufacturing method for the same, in which a single mesh formed by interlacing a plurality of filaments has a trunk portion and two legs hinged together. The legs include the entire plurality of filaments, and the trunk portion includes a subset of the same plurality of filaments. The method of fabrication comprises braiding the hinged legs on a mandrel and maintaining a wire ring between the two hinged legs to braid the trunk portion of the stent or implant.
    [0005] However, in the current minimally invasive surgery of the thoracic aorta and of a plurality of branched arteries, there is a difficulty in safely and smoothly implanting the respective branches of a multi-branch stent graft at the sites of injury within the respective blood vessel cavities to safely release the stent graft.
    [0006] Chinese patent application CN101897629A refers to a branched covered stent graft implant system, which describes the implantation of a unilateral branch stent or a single branch. This implant system cannot solve the problem of safe release during the multi-branch stent graft implantation process. In the case of the multi-branch stent graft, this system cannot ensure that the plurality of guide wires do not tangle and interfere with each other and cannot cause the respective guide wires to smoothly enter the respective cavities of the branched blood vessels. SUMMARY OF THE INVENTION
    [0007] In view of the above, the object of the invention is to solve the difficulty of safely and smoothly implanting a branched stent graft at the sites of injury of corresponding branched blood vessels in a minimally invasive surgery of the thoracic aorta and of a plurality of arteries branched.
    [0008] According to a first aspect of the invention, there is provided a guide catheter for a branched stent graft implant system, the guide catheter being used to guide a guide wire to a corresponding cavity of a branched blood vessel, so that a stent branch of a branched stent graft is subsequently drawn into its respective branched blood vessel cavity. The guide catheter is provided with at least one axially extending guidewire channel to guide the guidewire, each guidewire channel being provided with an inlet for the guidewire and a corresponding outlet for the guidewire, and the guide catheter. being axially divided between the guidewire inlet and the guidewire outlet of the respective guidewire channel to form an incision through which the respective guidewire can be separated from the guide catheter. In this way, the catheter can be separated from the guidewire with the catheter not being withdrawn at its proximal and distal ends.
    [0009] Generally, the branched stent graft has three stent branches to three branched aortic arteries. Thus, the guide catheter has three guidewire channels, each of the channels guiding a guidewire.
    [0010] The guide catheter is made of a polymeric composite material or a metallic material, or is a tube connection in the form of a composite structure. The guide catheter can be constructed as a double-layer or multi-layer tube connection, which includes an inner tube connection and an outer tube connection, both of which the inner and the outer tube connection are axially divided between the inlet. to the guide wire and the guide wire exit from the respective guide wire channel to form the incision. The guide catheter can also be constructed as a single tube connection. According to the invention, the incision is in the form of a line, a tear line or a groove.
    [0011] Alternatively, the guide catheter may be a combined split-portion tube connection, the incision is defined at the junction between the split portions.
    [0012] Preferably, the guide catheter is provided with a radiopaque mark at the exit of the respective guide wire. This can facilitate accurate positioning of the guide catheter during operation.
    [0013] In accordance with the invention, the guide catheter may additionally include an axially extending control guidewire channel to guide a control guidewire.
    [0014] Preferably, the guide catheter is also split axially in an extension of the control guidewire channel to form an incision, through which the control guidewire can be separated from the guide catheter. The incision can be in the form of a line, a tear line or a groove.
    [0015] When the guide catheter is a split-portion combined tube connection, an incision is further defined at the junction of the split-portions, through which the control guidewire can pass, so as to be separated from the guide catheter.
    [0016] According to a second aspect of the invention, there is provided a branched endoprosthesis implant system, which system comprises the aforementioned guide catheter.
    [0017] According to the invention, the branched stent graft implant system further comprises a manipulation handle, a sheath, a branched stent graft, a control guidewire for introducing and releasing the branched stent graft and a control switch, the stent graft branched being connected to the control guide wire and comprising at least one stent branch and the system comprising a guide wire for dragging the stent branch, the manipulation handle and control switch being controlled in such a way that, first, a guide catheter is introduced until the outlet of the respective guide wire is aligned with a corresponding branched blood vessel; thereafter, the guidewire is guided to a corresponding branched blood vessel cavity through the guide catheter; then the guide catheter is separated from the guide wire, with the guide wire being held in the branched blood vessel cavity; thereafter, the branched stent graft is introduced via the control guidewire such that the stent graft is drawn into its respective branched blood vessel cavity via the guidewire; finally, the branched stent graft is released via the control guidewire, and the guidewire and control guidewire are withdrawn.
    [0018] According to the invention, the guide catheter can be withdrawn after being separated from the guide wire, and the control guide wire can be independently introduced through another catheter.
    [0019] Preferably, the manipulation handle and the control switch can be controlled in such a way that both the guide wire and the control guide wire are guided to the respective aortic blood vessel cavity and to the blood vessel cavity. of the branched artery through the guide catheter and then the guide catheter is separated from the guide wire and control guide wire, with the guide wire and control guide wire being held in the respective cavities of the blood vessels.
    [0020] According to the invention, the control guide wire and the guide wire can be introduced simultaneously or not.
    [0021] The guide catheter and the stent implant system according to the invention can ensure that the guide wires do not tangle and interfere with each other during the implantation process and can ensure that the respective guide wires enter smoothly and securely in the respective branched blood vessel cavities. Additionally, in accordance with the invention, the guidewire is first introduced into the cavity of the branched blood vessel through the guide catheter, thus creating a passage for dragging the stent branch. In this way, the stent graft can be safely and smoothly implanted into its respective branched blood vessel cavity along the created passageway. BRIEF DESCRIPTION OF THE DRAWINGS
    [0022] Figure 1 is a schematic diagram of the construction of an endoprosthesis implant system and a guide catheter according to the invention;
    [0023] Figures 1A-1B are partial enlarged views of a guide catheter according to the invention;
    [0024] Figures 2-2A are a schematic diagram and a partial enlarged view of a guide catheter in the form of a single tube connection;
    [0025] Figures 3-3A are a schematic diagram and a partial enlarged view of a guide catheter in the form of a double layer tube connection;
    [0026] Figures 4A-4C are schematic views of incision types for a guide catheter;
    [0027] Figures 5A-5C are schematic views of incision types with the control guidewire channel also being provided with an incision;
    [0028] Figure 6 is a schematic diagram of a guide catheter in the form of a combined split-portion tube connection;
    [0029] Figure 7 is a schematic diagram of the introduction of a guidewire into a branched blood vessel cavity through a guide catheter;
    [0030] Figure 8 is a schematic diagram of dragging a stent graft to a branched blood vessel cavity via a guidewire;
    [0031] Figure 9 is a schematic diagram after the release of a stent graft. List of reference numbers
    [0032] 1 - Handling handle
    [0033] 2 - Control guide wire
    [0034] 3 - Control switch
    [0035] 4 - Sheath
    [0036] 5, 6, 7 - Guide wire
    [0037] 8, 8' - Guide catheter
    [0038] 9 - Branched endoprosthesis
    [0039] 10, 11, 12 - Endoprosthesis branch
    [0040] 20, 20' - Conical head of the guide catheter
    [0041] 30 - Guidewire removal incision
    [0042] 100, 200 - Incision in the form of a line
    [0043] 100', 200' - Incision in the form of a tear line
    [0044] 100", 200" - Incision in the form of a groove
    [0045] a, b, c - Entry for the guide wire
    [0046] d, e, f, - Output to the guide wire. DETAILED DESCRIPTION
    [0047] Detailed descriptions of the specific embodiments of the invention are given below, with reference to the figures.
    [0048] In the modalities below, the branched stent graft has three stent branches to three branched arteries. Thus, the guide catheter has three guidewire channels, each of the channels guiding a guidewire, in order to draw the three branches of the stent, respectively. However, it is evident to those skilled in the art that the number of guidewire channels may vary depending on the number of branches of the stent graft. If there is only one stent graft or two stent graft branches, there may be only one or two guidewire channels.
    [0049] Additionally, in the embodiments below, the guide catheter has a control guidewire cavity. However, it is evident to those skilled in the art that the control guidewire can be guided into the aortic blood vessel cavity through another catheter. Additionally, the control guide wire and guide wire can be introduced simultaneously or not.
    [0050] Additionally, for the purpose of description, the terms "distal end" and "proximal end" are used in this document. An end proximal to the operating end (i.e., a manipulating handle 1) is referred to as a proximal end, and an end distal to the manipulating handle 1 is referred to as a distal end.
    [0051] As shown in Figure 1, the stent graft system of the invention comprises a manipulation handle 1, a control guide wire 2, a control switch 3, a sheath 4, guide wires 5, 6, 7 and a guide catheter 8. Sheath 4 is made of a flexible polymeric material such as PET and PTFE. A t z z . . Releasable branched stent graft 9 and fully or semi-entirely enclosed by sheath 4. Alternatively, sheath 4 can be constructed as a multilayer sheath as described in Chinese patent application CN101897629A in the name of the applicant.
    [0052] The stent graft 9 has three stent graft branches 10, 11, 12, the stent graft body and the stent graft branches are connected to the control guide wire 2 and the guide wires 5, 6, 7, respectively, in order to be dragged, and both the stent graft branches and the stent graft body 1 are released by operating the control guide wire 2. The respective guide wires can be activated via the manipulation handle 1 and the control switch 3. The above contents are well known to those skilled in the art.
    [0053] Now go to Figures 1A-1B. As shown in the figures, the guide catheter 8 is provided, at its proximal end, with three inlets a, b, c for the guide wires and is provided, at its distal end, with three outlets d, e, f for the guide wires . The three guide wires 5, 6, 7 can be introduced from the inputs and extend out from the outputs. The outlets are additionally provided with a radiopaque mark (not shown) to facilitate accurate placement of the catheter. The guide catheter 8 is made of a polymeric composite material or a metallic material, or it is constructed as a tube connection in the form of a composite structure.
    [0054] As shown in Figures 2-2A, the guide catheter 8 is provided, at its distal end, with a conical head 20 to facilitate the introduction of the catheter into the blood vessel of the aorta and is axially divided between the inlet for the guide wire and exiting the guidewire from the respective guidewire channels to form incisions. Guide catheter 8 is additionally provided with a control guidewire channel (not indicated) to guide control guidewire 2. In this case, guide catheter 8 is a single tube connection. Alternatively, guide catheter 8 may be a double layer tube connection, as shown in Figures 3-3A, wherein both the inner and outer tube connection are axially divided between the inlets for the guide wires and the outlets for the guide wires from the respective guide wire channels to form incisions. Guidewire withdrawal incisions 30 are indicated in Figure 3A.
    [0055] The incisions may be incisions in the form of a line 100 as shown in Figure 4A, in the form of a tear line 100' as shown in Figure 4B, or in the form of a groove 100' as shown in Figure 4C. tear line incisions refer to a series of intermittent tear lines formed axially along the guide catheter 8. When the guide wire is separated from the guide catheter, a through incision can be easily formed by breaking the tear lines .
    The guide catheter 8 can be split axially in an extension of the control guidewire channel to form an incision, as shown in Figures 5A-5C. The incision may also be an incision in the form of a line 200, in the form of a tear line 200' or in the form of a groove 200".
    [0057] As an alternative, the guide catheter can be constructed as an 8' combined split-portion tube connection, as shown in Figure 6, and the incision is formed at the junction of the split portions of the tube connection. The 8' tube fitting also has a 20' taper head.
    [0058] Descriptions of the method of operation of the branched stent graft implant system of the invention are given as follows with reference to Figures 7-9. First, guide catheter 8 is introduced from the iliac artery of the human body until the respective guide wire outlets d, e, f of guide catheter 8 are aligned with corresponding branched blood vessels, respectively. A radiopaque mark may be provided at the guidewire exits to facilitate accurate placement of the catheter.
    [0059] Then, the guide wires 5, 6, 7 are introduced from the respective guide wire entries a, b, c of the guide catheter 8, respectively, until the guide wires 5, 6, 7 extend out of the guide wire outputs d, e, f, as shown in Figure 1. Then guide wires 5, 6, 7 are introduced into the respective branched blood vessel cavities, respectively, as shown in Figure 7. Control guide wire 2 can be introduced simultaneously with the guide wires through the guide catheter 8.
    [0060] Then, while the guide wires 5, 6, 7 are kept in the respective cavities of the branched blood vessel, the guide wires 5, 6, 7 are separated from the guide catheter 8 through the respective incisions, in order to withdraw the guide catheter 8 of the human body. Thus, the guide wires reach the desired positions of the blood vessel without getting tangled and interfering with each other. Control guidewire 2 can also be separated from guide catheter 8 through the respective incision.
    [0061] Then, the branched stent graft 9 is implanted in place through the branched stent graft catheter and the control guide wire 2, with the branches of the stent graft 10, 11, 12 being drawn into the respective cavities of the branched blood vessel through guide wires 5, 6, 7, as shown in Figure 8.
    [0062] Thereafter, the branched stent graft 9 is released by means of the control guide wire 2 and then the respective guide wires 5, 6, 7 and the control guide wire 2 are removed, as shown in Figure 9. The guide wires they may extend outside the branching aortic blood vessels and be removed distally. Finally, sheath 4 is removed from the human body, thus completing the endoprosthesis implantation operation.
    [0063] The guide catheter 8 of the invention ensures that the plurality of guide wires 5, 6, 7 do not entangle, not interfering with each other during the implantation process and can ensure that the guide wires enter the respective blood vessel cavities branched. Additionally, the branches of the stent are introduced along the passages created by the guide wires so that the branched stent graft 9 is safely and smoothly implanted at the sites of injury of the aortic blood vessel and the plurality of the branched arterial blood vessels and the stent 9 is released safely.
    [0064] The guide catheter and implant system provided by the invention are not only suitable for implanting a branched stent graft in the aorta, but also suitable for implanting a branched stent graft in other blood vessels.
    [0065] The invention is by no means limited to the specific description mentioned in the specific embodiments above. Those skilled in the art can think of other variations, modifications and additions without departing from the scope of the invention.
    权利要求:
    Claims (9)
    [0001]
    1. Guide catheter (8) for a branched stent graft implant system, which is used to introduce a guidewire (5, 6, 7) into a corresponding branched blood vessel cavity, in order to have a branched stent graft (10 11, 12) of a branched stent graft (9) is subsequently drawn into its corresponding branched blood vessel cavity, the guide catheter (8) is provided with at least one axially extending guidewire channel to guide the guidewire (5, 6, 7), wherein each guidewire channel is provided with an inlet (a,b,c) and a corresponding outlet (d,e,f) for the guidewire, the guide catheter (8) is axially divided between the guidewire inlet and guidewire outlet of the respective guidewire channel to form an incision through which the respective guidewire (5, 6, 7) can be separated from the guide catheter (8) , the guide catheter (8) further comprises an axially extending control guidewire channel to guide a control guidewire (2), wherein that the guide catheter (8) is axially divided into an extension of the control guide wire channel to form another incision, through which the control guide wire (2) can be separated from the guide catheter (8), characterized in that the catheter guide (8) is a tube connection (8') combining split portions, with the incision being defined at the junction between the split portions, and wherein the guide catheter (8) further comprises an extending control guidewire cavity axially to guide a control guidewire (2), and that another incision is further defined at the junction of the split portions, through which the control guidewire (2) can pass, so as to be separated from the guide catheter (8 ).
    [0002]
    2. Guide catheter (8), according to claim 1, characterized in that the guide catheter (8) is constructed as a double-layer or multi-layer tube connection, which includes an inner tube connection and a outer tube connection, both the inner and outer tube connections being axially divided between the guidewire inlet and the guidewire outlet of the respective guidewire channel to form the incision.
    [0003]
    3. Guide catheter (8), according to claim 1, characterized in that the guide catheter (8) is constructed as a single tube connection.
    [0004]
    4. Guide catheter (8), according to any one of claims 1 to 3, characterized in that the incision is in the form of a line (100, 200), a tear line (100', 200') or a groove (100”, 200”).
    [0005]
    5. Guide catheter (8), according to any one of claims 1 to 3, characterized in that the guide catheter (8) is provided with a radiopaque mark on its outlet for the guide wire (d, e, f ).
    [0006]
    6. Guide catheter (8), according to claim 1, characterized in that each incision is in the form of a line (200), a tear line (200') or a groove (200”).
    [0007]
    7. Branched endoprosthesis implant system, characterized in that it comprises a guide catheter (8), as defined in claim 1.
    [0008]
    8. Branched endoprosthesis implant system, according to claim 7, characterized in that it additionally comprises a manipulation handle (1), a sheath (4), a branched endoprosthesis (9), a control guide wire ( 2) to introduce and release the branched stent graft (9) and a control switch (3), the branched stent graft (9) being connected to the control guide wire (2) and comprising at least one stent graft (10, 11, 12), and the system comprising a guide wire (5, 6, 7) for dragging the endoprosthesis branch (10, 11, 12), whereby the manipulation handle (1) and the control switch (3) are controlled such that the guide catheter (8) is first introduced until the respective outlet for the guide wire is aligned with a corresponding branched blood vessel; thereafter, the guidewire (5, 6, 7) is guided to a corresponding cavity of the branched blood vessel through the guide catheter (8); then the guide catheter (8) is separated from the guide wire (5, 6, 7), with the guide wire being held in the cavity of the branched blood vessel; thereafter, the branched stent (9) is introduced via the control guide wire (2) in such a way that the stent branch (10, 11, 12) is drawn into the respective cavity of the branched blood vessel through the guide wire (5, 6, 7); finally, the branched stent graft (9) is released via the control guide wire (2) and the guide wire (5, 6, 7) and the control guide wire (2) are withdrawn.
    [0009]
    9. Branched endoprosthesis implant system, according to claim 8, characterized in that the manipulation handle (1) and the control switch (3) are controlled in such a way that the guide wire (5, 6 , 7) and the control guide wire (2) are guided to the respective blood vessel cavity through the guide catheter (8), and then the guide catheter (8) is separated from the guide wire (5, 6, 7) and of the control guide wire (2), with the guide wire and control guide wire being held in the blood vessel cavity.
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    同族专利:
    公开号 | 公开日
    CN102525699B|2015-06-10|
    BR112014017341A8|2017-07-04|
    WO2013104324A1|2013-07-18|
    EP2803340B1|2017-10-04|
    BR112014017341A2|2017-06-13|
    CN102525699A|2012-07-04|
    EP2803340A4|2015-10-28|
    EP2803340A1|2014-11-19|
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    WO2019227358A1|2018-05-30|2019-12-05|Li Lei|Precise stent implanting system for bifurcated vessel|
    法律状态:
    2018-02-27| B25A| Requested transfer of rights approved|Owner name: MICROPORT ENDOVASCULAR (SHANGHAI) CO., LTD. (CN) |
    2019-12-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-04-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-04| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/01/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    CN201210008588.6|2012-01-12|
    CN201210008588.6A|CN102525699B|2012-01-12|2012-01-12|Branch type intraoperative stent conveying system and guiding catheter for same|
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