Remounting device and method for covered stent after in-vitro windowing

Abstract

The invention discloses a device and method for reassembling a covered stent after in-vitro windowing, a stent system comprises a mandrel tube, a handle assembly, an outer sheath tube, the covered stent, a fixator and a receiver, and the released covered stent can be hung on the fixator and can be separated from the fixator; the pull wire penetrates through the mandrel tube and the handle assembly and is used for pulling the whole stent system to move, the gathering device is used for applying radial inward clamping force to the fixator, the loading tube and the loading tool are used for loading the covered stent with the window into the outer sheath tube, and the breaking device is used for cutting the loading tube. According to the reassembling device and the recycling method, in the reassembling process of the covered stent, the gatherer can prevent the fixing device from deforming, the covered stent after window opening is pulled into the loading tube and the outer sheath tube through the loading tool, the covered stent is not prone to being damaged, the stay wire can pull the covered stent into the outer sheath tube in a linear path, and therefore the covered stent can be recycled. And the position of the covered stent after the windowing is not easy to change after the covered stent is reassembled.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and particularly relates to a device and method for reinstalling an aortic arch covered stent after in vitro fenestration. Background Art

[0002] Minimally invasive treatment of diseases involving the aortic arch is a new treatment method for aortic diseases. Currently, the minimally invasive treatment of aortic arch diseases generally adopts the multi-branch endovascular reconstruction technology of the aortic arch. The main method is to use a stent delivery system to deliver an aortic covered stent to the position of the diseased aortic arch. The aortic covered stent supports inside the diseased aortic arch and forms a new blood flow channel, thereby achieving the treatment purpose.

[0003] However, since there are many branch arteries on the aortic arch (including the innominate artery, left common carotid artery, left subclavian artery, and variant vertebral artery and aberrant right subclavian artery, etc.), after the aortic covered stent is placed in the aortic arch, the aortic covered stent will block the blood supply of the branch arteries. These branch arteries are responsible for supplying blood to the brain and upper limbs. Once the brain blood supply is blocked for more than five minutes, it will cause severe irreversible damage to the brain due to hypoxia and even lead to the death of the patient. Therefore, it is necessary to fenestrate at the position of the branch artery corresponding to the aortic covered stent to ensure the normal blood supply in the branch artery.

[0004] Since the number, diameter, spacing, position, and direction of the branch arteries on the aortic arch vary from person to person and there is no obvious regularity, it is impossible to solve the blood flow supply problem of the branch arteries by prefabricating fenestrations on the aortic covered stent. Currently, it is generally solved by in-situ fenestration technology and fenestration technology.

[0005] The in-situ fenestration technology is to implant the aortic covered stent into the aortic arch, then perform in-situ fenestration according to the position of the branch arteries on the aortic arch, and then implant a branch artery covered stent at the in-situ fenestration position. However, the time of in-situ fenestration is difficult to control. If the in-situ fenestration operation time exceeds 5 minutes, it will cause intracranial ischemia, resulting in irreversible damage and even leading to the death of the patient. Therefore, it is difficult to be widely promoted and applied.

[0006] The in-vitro fenestration technology is to first obtain the number and position of the branch arteries on the patient's aortic arch, 3D print the model of the patient's aortic arch and branch arteries in vitro, then implant the aortic covered stent into the model for marking and fenestration, and then reinstall the aortic covered stent after in-vitro fenestration into the delivery sheath of the stent delivery system. The stent delivery system implants the fenestrated aortic covered stent into the patient's aortic arch. The whole process does not require in-vivo fenestration of the aortic covered stent, and the surgical safety is better.

[0007] However, in the prior art, the covered stent after fenestration is manually reinstalled into the delivery sheath. The manual reinstallation method of the covered stent is as follows: An assistant ties the most distal released covered stent with a silk thread to contract the covered stent; another assistant rotates the handle and pushes the delivery sheath forward; the operator manually inserts the covered stent into the delivery sheath to complete the reinstallation. This way of reinstalling the covered stent requires the operator to cooperate tacitly with two assistants. During the process of reinstalling the covered stent into the delivery sheath, it is easy to cause the covered stent to twist or be axially extruded. The retracted shape of the covered stent after fenestration reinstallation is different from the original shape, and the release performance of the covered stent will change. After the fenestrated covered stent is delivered to the aortic arch and released internally, it is easy to cause the fenestration position on the covered stent not to correspond to the position of the branch artery. Therefore, how to achieve the smooth reinstallation of the covered stent after extracorporeal fenestration and make the state of the covered stent after reinstallation consistent with the original product is a problem that urgently needs to be solved. Summary of the Invention

[0008] In view of this, the purpose of the present invention is to provide a reinstallation device and method for a covered stent after extracorporeal fenestration, so as to solve the problems of difficult extracorporeal reinstallation of the existing covered stent, easy deformation or damage of the covered stent during the rotation process, and difficulty in ensuring that the retracted shape of the covered stent after reinstallation is consistent with the original shape.

[0009] To solve the above technical problems, the technical solution of the present invention is as follows:

[0010] A reinstallation device for a covered stent after extracorporeal fenestration, the reinstallation device is used to reinstall the covered stent after extracorporeal fenestration into the outer sheath of the stent system, and the stent system includes:

[0011] A mandrel tube, with a handle assembly provided at its proximal end;

[0012] An outer sheath, sleeved on the outer periphery of the mandrel tube and detachably connected to the handle assembly at its proximal end;

[0013] A covered stent, which is a self-expanding structure and has a retracted state accommodated in the outer sheath and an expanded state that radially expands outward after the outer sheath is withdrawn; a bare stent section is provided at the distal end of the covered stent;

[0014] A fixator, movably sleeved on the mandrel tube and located at the distal end of the covered stent; the distal end of the covered stent is hung on the fixator, and when the covered stent is in the expanded state and the fixator moves proximally, the distal end of the covered stent can be detached from the fixator;

[0015] The reinstallation device includes:

[0016] A pull wire, the proximal end of which is fixed to the handle assembly or the core shaft tube of the stent system, and the distal end of which extends outward from the distal opening of the core shaft tube; the pull wire is used to pull the core shaft tube, the fixator and the stent graft to form an overall movement;

[0017] A loading tool is provided with a tapered cavity with a large proximal opening and a small distal opening; the distal end of the loading tool is detachably connected to the proximal end of the outer sheath tube, and the loading tool is used to guide the fixator and the coated stent on the core shaft tube into the interior of the outer sheath tube.

[0018] Furthermore, the reloading device also includes a loading tube and a breaker;

[0019] The distal end of the loading tool can be detachably connected to the proximal end of the loading tube. When the loading tool is connected to the proximal end of the loading tube, the loading tube is used to guide the fixator on the core shaft tube and the stent graft into the interior of the loading tube; when the loading tool is connected to the proximal end of the outer sheath tube, the loading tool is used to guide the fixator and the stent graft in the loading tube into the interior of the outer sheath tube;

[0020] The breaker is used to cut the loading tube after the fixator and the stent graft are loaded into the outer sheath tube, so that the proximal end of the outer sheath tube is connected to the handle assembly.

[0021] Furthermore, a conical head is fixed at the distal end of the core shaft tube, and the bracket system also includes a receiver, which is fixedly connected to the proximal end of the conical head and located at the distal end of the fixator. The proximal end of the receiver is provided with a receiving hole, and the fixator can be inserted into the receiving hole; the reinstallation device also includes a gatherer, which is used to apply a radial inward force to the fixator so that the fixator can be inserted into the receiving hole after being folded.

[0022] Furthermore, the reinstallation device also includes a protective cover, which is used to be sleeved on the outer periphery of the distal opening of the outer sheath tube before the coated stent is released from the distal end of the outer sheath tube to prevent the distal end of the outer sheath tube from deforming; the reinstallation device also includes a clamp, which is used to clamp the pull wire and pull the pull wire to move.

[0023] Furthermore, a pull wire limiter is provided on the pull wire, and the pull wire limiter is fixed on the core shaft tube of the stent system or its handle assembly or conical head.

[0024] Further, the handle assembly includes a cable handle and a tail end joint fixed to the proximal end of the cable handle. The cable stopper is connected to the distal end of the cable and fixed to the tail end joint; or, the cable stopper is connected to the proximal end of the cable and fixed to the tapered head at the distal end of the mandrel tube.

[0025] Further, a locking joint is provided at the distal end of the handle assembly, and the proximal end of the outer sheath tube is detachably connected to the locking joint.

[0026] An embodiment of the present invention further provides a method for recycling a covered stent after extracorporeal fenestration. The recycling method is used to reinstall the covered stent after extracorporeal fenestration into the outer sheath tube of the stent system; the stent system includes:

[0027] A mandrel tube, with a handle assembly provided at its proximal end;

[0028] An outer sheath tube, sleeved on the outer periphery of the mandrel tube and detachably connected to the handle assembly at its proximal end;

[0029] A covered stent, which is a self-expanding structure and has a retracted state accommodated in the outer sheath tube and an expanded state radially expanding outward after the outer sheath tube is withdrawn; a bare stent section is provided at the distal end of the covered stent;

[0030] A fixator, movably sleeved on the mandrel tube and located at the distal end of the covered stent; the distal end of the covered stent is hung on the fixator. When the covered stent is in the expanded state and the fixator moves proximally, the distal end of the covered stent can be disengaged from the fixator;

[0031] The recycling method includes the following steps:

[0032] S1. Pass a cable through the mandrel tube and the handle assembly of the stent system, and remove the outer sheath tube from the stent system. At this time, the bare stent section at the distal end of the covered stent after fenestration is hung on the fixator;

[0033] S2. Sleeve the loading tooling and the outer sheath tube on the cable, connect the loading tooling to the proximal end of the outer sheath tube, keep the overall position formed by the outer sheath tube and the loading tooling unchanged, pull the cable distally, and the cable drives the entire stent system to move relative to the outer sheath tube and the loading tooling. The covered stent after fenestration is pulled into the outer sheath tube through the loading tooling;

[0034] S3. Then remove the loading tooling at the proximal end of the outer sheath tube, pull the cable to bring the proximal end of the outer sheath tube and the handle assembly closer, and lock and fix the proximal end of the outer sheath tube to the handle assembly to end the assembly.

[0035] Further, the reinstallation device further includes a loading tube and a cutter; the distal end of the loading tooling is also detachably connected to the proximal end of the loading tube, and the cutter is used to cut the loading tube; the step of S2 includes:

[0036] S21. Sleeve the loading tube and the loading tooling on the guy wire, and connect the loading tooling to the proximal end of the loading tube; keep the overall position formed by the loading tube and the loading tooling unchanged, pull the guy wire distally, the guy wire drives the entire stent system to move relative to the loading tube and the loading tooling, and the fenestrated covered stent is pulled into the loading tube through the loading tooling, and finally the loading tooling is removed from the loading tube;

[0037] S22. Sleeve the outer sheath tube on the guy wire, and connect the removed loading tooling to the proximal end of the outer sheath tube; keep the overall position formed by the loading tube and the loading tooling unchanged, pull the guy wire distally, the guy wire drives the entire stent system to move relative to the outer sheath tube and the loading tooling, and the fenestrated covered stent in the loading tube is loaded into the outer sheath tube through the loading tooling; use the cutter to cut and remove the loading tube.

[0038] Further, a conical head is fixed at the distal end of the mandrel tube, the stent system further includes a receiver, the receiver is fixedly connected to the proximal end of the conical head and is located at the distal end of the fixator, and a receiving hole is provided at the proximal end of the receiver;

[0039] Before the step of S1, it further includes: S0. Before the handle assembly releases the non-fenestrated covered stent from the outer sheath tube, a protective sleeve is sleeved on the outer periphery of the distal opening of the outer sheath tube;

[0040] Before the step of S2 and after the step of S1, it further includes: clamping the outside of the fixator with a gatherer, and pushing the fixator distally to insert the fixator into the receiving hole of the receiver;

[0041] In the steps of S2 and S3, a clamp is used to clamp the guy wire to pull the guy wire to move.

[0042] Further, before the step of S1, it further includes: suturing a branch stent at the fenestration position of the fenestrated covered stent.

[0043] The technical solution of the present invention has the following advantages: During the reinstallation process of the covered stent, by detachably connecting a loading tool with a conical cavity having a large proximal opening and a small distal opening to the proximal end of the outer sheath tube, and utilizing the overall movement formed by pulling the core shaft tube, the fixator, and the covered stent with a wire, it is convenient to smoothly pull the fixator and the covered stent on the core shaft tube into the interior of the outer sheath tube, which can reduce the damage to the proximal opening of the outer sheath tube during the reinstallation process of the covered stent. In addition, the gatherer clamps the fixator, which can prevent the fixing pins on the fixator from turning outwards, facilitating the smooth pushing of the fixator into the receiving hole of the receiver. The method of first loading the fenestrated covered stent into the loading tube and then into the outer sheath tube can further reduce the damage to the covered stent. The entire reinstallation process only requires a wire, a loading tool, and a loading tube to pull the fenestrated covered stent into the outer sheath tube, and the matching breaker cuts the loading tube. The reinstallation device has a simple structure and the reinstallation method is easy to operate; during the reinstallation process, the covered stent can be pulled into the outer sheath tube along a straight path by the wire. After reinstallation, the fenestrated covered stent is not prone to torsion or axial extrusion. The retracted form of the fenestrated covered stent after reinstallation can be the same as the original form of the non-fenestrated covered stent pre-installed in the stent system. The release performance of the fenestrated covered stent will not change. After the fenestrated covered stent is delivered to the aortic arch and released internally, it is not easy to have the problem that the fenestration position on the covered stent does not correspond to the position of the branch artery, which is beneficial to the smooth progress of the subsequent endovascular stent-graft treatment surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0045] Figure 1 It is a schematic structural diagram of the non-fenestrated covered stent part being released outward from the distal end of the outer sheath tube in the first embodiment of the present invention;

[0046] Figure 2 It is a schematic structural diagram of the bare stent segment of the fenestrated covered stent hanging on the fixator and the gatherer clamping outside the fixator in the first embodiment of the present invention;

[0047] Figure 3 It is a schematic structural diagram of the bare stent segment of the fenestrated covered stent hanging on the fixator when the fixator is inserted into the receiver in the first embodiment of the present invention;

[0048] Figure 4 It is a schematic structural diagram of the fenestrated covered stent being loaded into the loading tube through the loading tool in the first embodiment of the present invention;

[0049] Figure 5 Schematic diagram of the structure when the fenestrated covered stent in the loading tube in the first embodiment of the present invention is loaded into the outer sheath tube through the loading tooling;

[0050] Figure 6 Schematic diagram of the structure when the cutter in the first embodiment of the present invention cuts the loading tube;

[0051] Figure 7 Schematic diagram of the structure of the stent system after the fenestrated covered stent in the first embodiment of the present invention is reinstalled;

[0052] Figure 8 Schematic diagram of the structure when the fenestrated covered stent in the second embodiment of the present invention is loaded into the loading tube through the loading tooling;

[0053] Figure 9 Schematic diagram of the structure of the stent system after the fenestrated covered stent in the second embodiment of the present invention is reinstalled.

[0054] Explanation of reference numerals: A01, wire; A02, protective sleeve; A03, wire stopper; A04, gatherer; A05, clamp; A06, loading tube; A07, loading tooling; A08, cutter; B01, tapered head;

[0055] B02, non-fenestrated covered stent; B03, outer sheath tube; B04, wire handle; B05, tail end joint; B06, delivery handle; B07, fixed handle; B08, locking joint; B09, receiver; B10, fixator; B11, guide; B12, fenestrated covered stent; B13, mandrel tube. Detailed implementation manners

[0056] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0057] In the description of the present application, it should be understood that the terms "proximal end" and "distal end" throughout the text refer to near and far relative to the operator. When the present invention is in use, the end close to the doctor or the operator is the "proximal end", that is, the end where the operator is located, and the end far from the doctor or the operator is the "distal end". The above-mentioned orientation description is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0058] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection or an indirect connection through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0059] Endovascular aortic repair is a minimally invasive endovascular treatment technique. Through an incision in the femoral artery, a covered stent is sent to the diseased site of the aorta, and the aortic lesion is repaired from within the artery, thus avoiding open surgery; compared with traditional surgical procedures, endovascular aortic repair greatly reduces the trauma of surgery, significantly shortens the operation time, and reduces surgical complications and mortality.

[0060] The in vitro fenestration technique of aortic covered stents is mainly used for the treatment of aortic aneurysms or aortic dissections in the aortic arch. The biggest difficulty in endovascular treatment surgery is to retain the blood flow supply of important branch arteries in the aortic arch while isolating the aorta and the dissection tear within the cavity. Therefore, according to the number and location of the branch arteries above the aortic arch of the patient, fenestrations need to be made at the corresponding positions of the covered stent before the covered stent is implanted into the aortic arch.

[0061] However, in the prior art, the covered stent after fenestration is manually reinstalled into the delivery sheath of the stent system. During the reinstallation process of the covered stent, the covered stent is prone to torsion or axial extrusion. The retracted shape of the covered stent after fenestration reinstallation is different from the original shape, and the release performance of the covered stent will change. After the covered stent after fenestration is delivered to the aortic arch and released, it is easy to cause the position of the fenestration on the covered stent to not correspond to the position of the branch artery. Therefore, how to achieve smooth reinstallation of the covered stent after in vitro fenestration and ensure that the state of the covered stent after reinstallation is the same as that of the original product is a problem that urgently needs to be solved.

[0062] To solve the above problems, the present invention provides a reinstallation device for a covered stent after in vitro fenestration. This reinstallation device is used to reinstall the covered stent B12 after in vitro fenestration into the outer sheath tube B03 of the stent system. To distinguish the reinstallation device and the stent system, the components with the code A are the components of the reinstallation device, and the components with the code B are the components of the stent system.

[0063] Embodiment 1

[0064] As Figure 1 - Figure 7 shown, the stent system includes a mandrel tube B13, a handle assembly, an outer sheath tube B03, a covered stent, a fixator B10, and a receiver B09.

[0065] In some embodiments, the mandrel tube B13 is a long tubular structure extending longitudinally, and a conical head B01 is fixed at the distal end of the mandrel tube B13. The handle assembly includes a wire pull handle B04, a delivery handle B06 and a fixed handle B07 connected in sequence from the proximal end to the distal end, the fixed handle B07 is detachably connected to the distal end of the delivery handle B06, the wire pull handle B04 is connected to the proximal end of the delivery handle B06; the delivery handle B06 is fixedly connected to the proximal end of the mandrel tube B13. The outer sheath tube B03 is sleeved on the outer periphery of the mandrel tube B13, and a locking joint B08 is provided at the distal end of the delivery handle B06, and the proximal end of the outer sheath tube B03 is detachably connected to the locking joint B08. The coated stent is a self-expanding structure, and the coated stent has a retracted state contained in the outer sheath tube B03 and an expanded state radially expanded outward after the outer sheath tube B03 is withdrawn; the distal end of the coated stent is provided with a bare stent segment. For ease of description, the stent graft before and after fenestration is recorded as the unfenestrated stent graft B02 and the stent graft after fenestration B12, respectively.

[0066] Among them, the fixator B10 is movably sleeved on the core shaft tube B13, and the fixator B10 is located at the distal end of the coated stent. The fixator B10 can specifically adopt a mechanical lock or a ring structure. The proximal end of the fixator B10 is connected with a pull rope for pulling the fixator B10 to move axially along the core shaft tube B13. The bare stent segment at the distal end of the coated stent is hung on the fixator B10. When the coated stent is released and unfolded to the unfolded state in the body, the fixator B10 is pulled proximally by the pull rope, and the bare stent segment at the distal end of the coated stent can be detached from the fixator B10, so that the coated stent is implanted in the corresponding position in the body, and the core shaft tube B13 and the fixator B10 of the stent system can be withdrawn. In some embodiments, the end of the bare stent segment is temporarily connected to the fixator B10 through a barb, a protrusion or an elastic arm. This design allows the coated stent and the fixator to remain connected in the early stage of release, while creating conditions for subsequent detachment. When the outer sheath tube B03 is withdrawn in vitro, the stent graft expands by itself, and the bare stent segment at the distal end of the stent graft hangs on the fixture B10. The stent graft and the fixture B10 are not separated, which is convenient for the subsequent reinstallation of the stent graft. When the outer sheath tube B03 is withdrawn in vitro, the stent graft expands by itself in vivo, and the bare stent segment at the distal end of the stent graft hangs on the fixture B10. When the stent graft is released in vivo, the fixture B10 is pulled toward the proximal end by the pull rope. At this time, the bare stent segment at the distal end of the stent graft and the fixture B10 will be separated, so that the core shaft tube B13 and the fixture B10 can be withdrawn from the body.

[0067] In some embodiments of the present embodiment, the receiver B09 is located at the distal end of the fixator B10. The receiver B09 is fixed to the proximal end of the tapered head B01 or the receiver B09 and the tapered head B01 are of an integral structure. A receiving hole is provided at the proximal end of the receiver B09, and the fixator B10 can be inserted into the receiving hole. In some alternative embodiments, the receiver B09 of the stent system can also be omitted.

[0068] In some embodiments of the present embodiment, the reinstallation device includes a pulling wire A01 and a loading tooling A07. The pulling wire A01 is specifically a steel wire. Among them, the pulling wire A01 passes through the entire stent system composed of the mandrel tube B13 and the handle assembly. The proximal end of the pulling wire A01 is fixed to the pulling wire handle B04, and the distal end of the pulling wire A01 extends outwards from the distal opening of the mandrel tube B13; the pulling wire A01 is used to pull the whole formed by the mandrel tube B13, the fixator B10 and the fenestrated covered stent B12 to move linearly. In some alternative embodiments, the proximal end of the pulling wire A01 can also be directly fixed to the tapered head B01.

[0069] In some embodiments of the present embodiment, the reinstallation device further includes a gatherer A04. The gatherer A04 has a scissor-like structure similar to pliers. One end of the gatherer A04 is an operating end and the other end is a gathering end. The gathering ends are closed together in the natural state, and the gathering ends can be driven to open by holding the operating end. In the present application, the gathering ends of the gatherer A04 are clamped outside the fixator B10, and the gatherer A04 exerts a radially inward acting force on the fixator B10 to prevent the fixing pins on the fixator B10 from being radially expanded outwards or even folded under the radial expansion force of the bare stent section, protecting the fixator B10 from deformation and also facilitating the smooth pushing of the fixator B10 into the receiver B09.

[0070] In some embodiments of the present embodiment, the backloading device further includes a loading tube A06 and a cutter A08. Both the loading tube A06 and the loading tooling A07 can be sleeved on the pull wire A01. The loading tube A06 is in a long tubular shape and can be cut by the cutter A08. The loading tooling A07 is conical, and a conical cavity with a large proximal opening and a small distal opening is provided inside the loading tooling A07. The distal end of the loading tooling A07 is detachably connected to the proximal end of the loading tube A06, and the distal end of the loading tooling A07 is also detachably connected to the proximal end of the outer sheath tube B03. During the external backloading process of the covered stent, when the loading tooling A07 is connected to the proximal end of the loading tube A06, the loading tooling A07 is used to guide the conical head B01, the fixator B10, and the fenestrated covered stent B12 into the interior of the loading tube A06; when the loading tooling A07 is connected to the proximal end of the outer sheath tube B03, the loading tooling A07 is used to guide the fixator B10 and the fenestrated covered stent B12 inside the loading tube A06 into the interior of the outer sheath tube B03. The cutter A08 is used to cut the loading tube A06 after the fixator B10 and the fenestrated covered stent B12 are loaded into the outer sheath tube B03, so that the proximal end of the outer sheath tube B03 can be connected to the locking joint B08 of the delivery handle B06. The fenestrated covered stent B12 is pulled into the loading tube A06 and the outer sheath tube B03 through the loading tooling A07, which is not likely to damage the fenestrated covered stent B12; the method of first loading the fenestrated covered stent B12 into the loading tube A06 and then into the outer sheath tube B03 can further reduce the damage to the fenestrated covered stent B12. Moreover, the loading tooling A07 can be reused, which can reduce the complexity of the backloading device. In some alternative embodiments, the loading tube A06 and the cutter A08 can be omitted. During the external backloading process of the covered stent, the distal end of the loading tooling A07 is directly connected to the proximal end of the outer sheath tube B03, and the loading tooling A07 guides the conical head B01, the fixator B10, and the fenestrated covered stent B12 directly into the interior of the outer sheath tube B03.

[0071] In some embodiments of the present embodiment, the backloading device further includes a clamp A01 and a protective sleeve A02. The clamp A05 is used to clamp the pull wire A01 and pull the pull wire A01 to move; the protective sleeve A02 is used to sleeve the outer periphery of the distal opening of the outer sheath tube B03 before the covered stent is released from the distal end of the outer sheath tube B03 to prevent the distal end of the outer sheath tube B03 from deforming.

[0072] In some embodiments of the present embodiment, the backloading device further includes a pull wire stopper A03 fixedly connected to the proximal end of the pull wire A01. A tail end joint B05 is fixed to the proximal end of the pull wire handle B04, and the pull wire stopper A03 is fixed on the tail end joint B05. The pull wire stopper A03 is beneficial to pulling the covered stent into the outer sheath tube B03 along a straight path through the pull wire A01, so that the fenestrated covered stent B12 is not likely to twist or be axially extruded after backloading.

[0073] For the recycling device of the covered stent after external fenestration, only the pull wire A01, the loading tooling A07 and the loading tube A06 are needed to pull the covered stent B12 after fenestration into the outer sheath tube B03, and the matching cutter A08 cuts the loading tube A06, so the recycling device has a simple structure; during the recycling process, the covered stent can be pulled into the outer sheath tube B03 along a straight path by the pull wire A01. After recycling, the covered stent B12 after fenestration is not prone to torsion or axial extrusion. The retracted form of the covered stent B12 after fenestration can be the same as the original form of the non-fenestrated covered stent B02 pre-installed in the stent system. The release performance of the covered stent B12 after fenestration will not change. After the covered stent B12 after fenestration is delivered to the aortic arch and released internally, there is not likely to be a problem that the fenestration position on the covered stent B12 after fenestration does not correspond to the position of the branch artery, which is beneficial to the smooth progress of the subsequent endovascular stent-grafting treatment operation.

[0074] Embodiment 1 of the present invention also provides a method for recycling a covered stent after external fenestration. The recycling method is used to reinstall the covered stent B12 after external fenestration into the outer sheath tube B03 of the stent system. In some embodiments, the recycling method includes the following steps:

[0075] Step S1: Pass the pull wire A01 through the mandrel tube B13 and the handle assembly of the stent system, and remove the outer sheath tube B03 from the stent system. At this time, the bare stent segment at the distal end of the covered stent B12 after fenestration hangs on the fixator B10; then use the gatherer A04 to clamp the outside of the fixator B10 and push the fixator B10 in the distal direction so that the fixator B10 is inserted into the receiving hole of the receiver B09;

[0076] Step S21: Sleeve the loading tube A06 and the loading tooling A07 on the pull wire A01, connect the loading tooling A07 to the proximal end of the loading tube A06, and fix the proximal end of the pull wire A01 on the handle assembly; keep the overall position formed by the loading tube A06 and the loading tooling A07 unchanged, pull the pull wire A01 in the distal direction, and the pull wire A01 drives the entire stent system to move relative to the loading tube A06 and the loading tooling A07. The covered stent B12 after fenestration is pulled into the loading tube A06 through the loading tooling A07, and finally the loading tooling A07 is removed from the loading tube A06;

[0077] Step S22: Sleeve the outer sheath tube B03 on the pull wire A01, and connect the removed loading tooling A07 to the proximal end of the outer sheath tube B03; keep the overall position formed by the loading tube A06 and the loading tooling A07 unchanged, pull the pull wire A01 in the distal direction, and the pull wire A01 drives the entire stent system to move relative to the outer sheath tube B03 and the loading tooling A07. The covered stent B12 after fenestration in the loading tube A06 is loaded into the outer sheath tube B03 through the loading tooling A07; use the cutter A08 to cut and remove the loading tube A06;

[0078] Step S3: Remove the loading tool A07 at the proximal end of the outer sheath tube B03, pull the wire A01, bring the proximal end of the outer sheath tube B03 closer to the handle assembly, and lock and fix the proximal end of the outer sheath tube B03 on the handle assembly to complete the assembly.

[0079] In an alternative embodiment, during the process of reloading the covered stent outside the body, the loading tube A06 and the dissector A08 can also be omitted. The distal end of the loading tool A07 is directly connected to the proximal end of the outer sheath tube B03. Keep the overall position formed by the outer sheath tube B03 and the loading tool A07 unchanged, pull the wire A01 distally. The wire A01 drives the entire stent system to move relative to the outer sheath tube B03 and the loading tool A07, and the fenestrated covered stent B12 is pulled into the outer sheath tube B03 through the loading tool A07.

[0080] In some embodiments, before step S1, it further includes: Step S0: Before the handle assembly releases the non-fenestrated covered stent B02 from the outer sheath tube B03, a protective sleeve A02 is sleeved on the outer periphery of the distal opening of the outer sheath tube B03. The protective sleeve A02 can prevent the proximal end of the outer sheath tube B03 from deforming. After step S1 and after step S21, it further includes: Clamp the outside of the fixator B10 with a gatherer A04, and push the fixator B10 distally to insert the fixator B10 into the receiving hole of the receiver B09. In steps S2 and S3, a clamp A05 is used to clamp the wire A01 to pull the wire A01 to move.

[0081] During the in vitro reloading process of the covered stent, by detachably connecting a loading tool A07 with a conical cavity having a large proximal opening and a small distal opening to the proximal end of the outer sheath tube A03, the overall movement formed by pulling the core shaft tube B13, the fixator B10, and the fenestrated covered stent B12 with the pulling wire A01 is utilized, which facilitates smoothly pulling the fixator B10 on the core shaft tube B13 and the fenestrated covered stent B12 into the interior of the outer sheath tube A03, and can reduce the damage caused to the proximal opening of the outer sheath tube A03 during the reloading process of the fenestrated covered stent B12. In addition, the gatherer A04 can clamp and deform the fixator B10 to prevent the fixing pins on the fixator B10 from turning outwards, which is convenient for the fixator B10 to be smoothly pushed into the receiving hole of the receiver B09. The fenestrated covered stent B12 is pulled into the loading tube A06 and the outer sheath tube B03 through the loading tool A07, and it is not easy to cause damage to the fenestrated covered stent B12. The method of first loading the fenestrated covered stent B12 into the loading tube A06 and then into the outer sheath tube B03 can further reduce the damage to the fenestrated covered stent B12. The entire reloading process only requires the pulling wire A01, the loading tool A07, and the loading tube A06 to pull the fenestrated covered stent B12 into the outer sheath tube B03, and the matching breaker A08 cuts the loading tube A06. The reloading device has a simple structure and the reloading method is convenient to operate; during the reloading process, the fenestrated covered stent B12 can be pulled into the outer sheath tube B03 along a straight path by the pulling wire A01. After reloading, the fenestrated covered stent B12 is not prone to torsion or axial extrusion. The retracted form of the fenestrated covered stent B12 after reloading can be the same as the original form of the non-fenestrated covered stent B02 pre-installed in the stent system. The release performance of the fenestrated covered stent B12 will not change. After the fenestrated covered stent B12 is released inside the aortic arch during delivery, it is not easy to have the problem that the fenestration position on the fenestrated covered stent B12 does not correspond to the position of the branch artery, which is beneficial to the smooth progress of the subsequent endovascular stent-grafting treatment surgery.

[0082] Embodiment 2

[0083] Embodiment 2 of the present invention provides a recovery device and a recovery method for a covered stent after in vitro fenestration, as Figure 8 and Figure 9 shown. The overall structure and working principle of the reloading device in the Embodiment 2 solution are basically the same as those in the Embodiment 1 solution. The difference between the recovery method and that in Embodiment 1 is that before reloading the fenestrated covered stent B12, a branch stent is sutured at the fenestration position of the fenestrated covered stent B12. Since the setting of the branch stent will increase the cross-sectional area of the overall compressed stent, in order to protect the stent from damage, a sheath tube B14 with a larger size is selected for assembly.

[0084] Obviously, the above embodiments are merely examples for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all implementation manners here. And the obvious changes or modifications derived therefrom still fall within the protection scope of the present invention.

Claims

1. A reinstallation device after extracorporeal fenestration of a covered stent, characterized in that, The reinstallation device is used to reinstall the coated stent (B12) after the in vitro fenestration into the outer sheath (B03) of the stent system, and the stent system comprises: A mandrel tube (B13) having a handle assembly at its proximal end; An outer sheath tube (B03) is sleeved on the outer circumference of the core shaft tube (B13) and the proximal end of which is detachably connected to the handle assembly; The coated stent is a self-expanding structure having a retracted state in which it is contained in the outer sheath tube (B03) and an expanded state in which it is radially expanded outward after the outer sheath tube (B03) is withdrawn; A fixator (B10) is movably sleeved on the core shaft tube (B13) and is located at the distal end of the stent graft; the distal end of the stent graft is hung on the fixator (B10), and when the stent graft is in an expanded state and the fixator (B10) moves toward the proximal end, the distal end of the stent graft can be separated from the fixator (B10); The reloading device comprises: A pull wire (A01), the proximal end of which is fixed on the stent system; the pull wire (A01) is used to pull the stent system to move; A loading tool (A07) is provided with a conical cavity having a large proximal opening and a small distal opening; the distal end of the loading tool (A07) is detachably connected to the proximal end of the outer sheath tube (B03), and the loading tool (A07) is used to guide the fixator (B10) and the coated stent on the core shaft tube (B13) into the interior of the outer sheath tube (B03).

2. The device for reinstalling the covered stent after external fenestration according to claim 1, characterized in that, The reloading device also includes a loading tube (A06) and a breaker (A08); The distal end of the loading tool (A07) can also be detachably connected to the proximal end of the loading tube (A06). When the loading tool (A07) is connected to the proximal end of the loading tube (A06), the loading tube (A06) is used to guide the fixator (B10) and the coated stent on the core shaft tube (B13) into the interior of the loading tube (A06); when the loading tool (A07) is connected to the proximal end of the outer sheath tube (B03), the loading tool (A07) is used to guide the fixator (B10) and the coated stent in the loading tube (A06) into the interior of the outer sheath tube (B03); The breaker (A08) is used to cut the loading tube (A06) after the fixator (B10) and the coated stent are loaded into the outer sheath tube (B03), so that the proximal end of the outer sheath tube (B03) is connected to the handle assembly.

3. The reinstallation device after external fenestration of the covered stent according to claim 1, characterized in that A conical head (B01) is fixed at the distal end of the core shaft tube (B13), and the support system also includes a receiver (B09), which is fixedly connected to the proximal end of the conical head (B01) and located at the distal end of the fixer (B10). The proximal end of the receiver (B09) is provided with a receiving hole, and the fixer (B10) can be inserted into the receiving hole; the reinstallation device also includes a gatherer (A04), and the gatherer (A04) is used to apply a radial inward force to the fixer (B10) so that the fixer (B10) can be inserted into the receiving hole after being folded.

4. The device for reinstalling the covered stent after external fenestration according to claim 1, wherein The reinstallation device further includes a protective sleeve (A02) which is used to sleeve the outer periphery of the distal opening of the outer sheath tube (B03) before the covered stent is released from the distal end of the outer sheath tube (B03) to prevent the distal end of the outer sheath tube (B03) from deforming; and / or, the reinstallation device further includes a clamp (A05) which is used to clamp the pull wire (A01) and pull the pull wire (A01) to move.

5. The backloading device after extracorporeal fenestration of the covered stent according to claim 1, wherein A pull wire stopper (A03) is provided on the pull wire (A01), and the pull wire stopper (A03) is fixed on the mandrel tube (B13) of the stent system or its handle assembly or the tapered head (B01).

6. The backloading device after external fenestration of the covered stent according to claim 5, characterized in that The handle assembly includes a pull wire handle (B04) and a tail end joint (B05) fixed to the proximal end of the pull wire handle (B04). The pull wire stopper (A03) is connected to the proximal end of the pull wire (A01), and the pull wire stopper (A03) is fixed on the tail end joint (B05); or, The pull wire stopper (A03) is connected to the distal end of the pull wire (A01), and the pull wire stopper (A03) is fixed on the tapered head (B01) at the distal end of the mandrel tube (B13).

7. The device for reinstalling the covered stent after external fenestration according to claim 1, characterized in that, A locking joint (B08) is provided at the distal end of the handle assembly, and the proximal end of the outer sheath tube (B03) is detachably connected to the locking joint (B08).

8. A method for retrieving a covered stent after fenestration in vitro, characterized in that, The recovery method is used to reinstall the covered stent (B12) after in vitro fenestration into the outer sheath tube (B03) of the stent system; the stent system includes: A mandrel tube (B13) with a handle assembly provided at its proximal end; An outer sheath tube (B03) sleeved on the outer periphery of the mandrel tube (B13) and the proximal end thereof is detachably connected to the handle assembly; A covered stent, which is a self-expanding structure and has a retracted state accommodated in the outer sheath tube (B03) and an expanded state radially expanding outward after the outer sheath tube (B03) is withdrawn; A fixator (B10) movably sleeved on the mandrel tube (B13) and located at the distal end of the covered stent; the distal end of the covered stent is hung on the fixator (B10), and when the covered stent is in the expanded state and the fixator (B10) moves proximally, the distal end of the covered stent can be disengaged from the fixator (B10); The recovery method includes the following steps: S1. Pass a pull wire (A01) through the mandrel tube (B13) of the stent system to remove the outer sheath tube (B03) from the stent system. At this time, the distal end of the fenestrated covered stent (B12) is hung on the fixator (B10); S2. Sheath the loading tooling (A07) and the outer sheath tube (B03) on the pulling wire (A01), connect the loading tooling (A07) to the proximal end of the outer sheath tube (B03), keep the overall position formed by the outer sheath tube (B03) and the loading tooling (A07) stationary, pull the pulling wire (A01) distally. The pulling wire (A01) drives the entire stent system to move relative to the outer sheath tube (B03) and the loading tooling (A07). The fenestrated membrane stent (B12) is loaded into the outer sheath tube (B03) through the loading tooling (A07). S3. Remove the loading tooling (A07) at the proximal end of the outer sheath tube (B03), pull the pulling wire (A01) to bring the proximal end of the outer sheath tube (B03) close to the handle assembly, and lock and fix the proximal end of the outer sheath tube (B03) to the handle assembly to complete the assembly.

9. The method for retrieving a covered stent after external fenestration according to claim 8, wherein The reinstallation device further includes a loading tube (A06) and a cutter (A08); the distal end of the loading tooling (A07) is also detachably connected to the proximal end of the loading tube (A06), and the cutter (A08) is used to cut the loading tube (A06); the steps of S2 include: S21. Sheath the loading tube (A06) and the loading tooling (A07) on the pulling wire (A01), and connect the loading tooling (A07) to the proximal end of the loading tube (A06); keep the overall position formed by the loading tube (A06) and the loading tooling (A07) stationary, pull the pulling wire (A01) distally. The pulling wire (A01) drives the entire stent system to move relative to the loading tube (A06) and the loading tooling (A07). The fenestrated membrane stent (B12) is pulled into the loading tube (A06) through the loading tooling (A07), and finally the loading tooling (A07) is removed from the loading tube (A06). S22. Sheath the outer sheath tube (B03) on the pulling wire (A01), and connect the removed loading tooling (A07) to the proximal end of the outer sheath tube (B03); keep the overall position formed by the loading tube (A06) and the loading tooling (A07) stationary, pull the pulling wire (A01) distally. The pulling wire (A01) drives the entire stent system to move relative to the outer sheath tube (B03) and the loading tooling (A07). The fenestrated membrane stent (B12) in the loading tube (A06) is loaded into the outer sheath tube (B03) through the loading tooling (A07); use the cutter (A08) to cut and remove the loading tube (A06).

10. The recovery method for the covered stent after extracorporeal fenestration according to claim 8, wherein, A conical head (B01) is fixed to the distal end of the mandrel tube (B13), and the stent system further includes a receiver (B09). The receiver (B09) is fixedly connected to the proximal end of the conical head (B01) and is located at the distal end of the fixator (B10). A receiving hole is provided at the proximal end of the receiver (B09). Before the step of S1, it further includes: S0. Before the handle assembly releases the non-fenestrated membrane stent (B02) from the outer sheath tube (B03), sheath the outer periphery of the distal opening of the outer sheath tube (B03) with a protective sleeve (A02). After the step of S1 and before the step of S2, it further includes: using a gatherer (A04) to clamp the outside of the fixator (B10), and pushing the fixator (B10) in the distal direction to insert the fixator (B10) into the receiving hole of the receiver (B09). In the steps of S2 and S3, use a clamp (A05) to clamp the wire (A01) to pull the wire (A01) to move.

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