CN108652786B - Bracket windowing device and bracket system - Google Patents

Bracket windowing device and bracket system Download PDF

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Publication number
CN108652786B
CN108652786B CN201710208449.0A CN201710208449A CN108652786B CN 108652786 B CN108652786 B CN 108652786B CN 201710208449 A CN201710208449 A CN 201710208449A CN 108652786 B CN108652786 B CN 108652786B
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China
Prior art keywords
catheter
stent
wire
guide wire
bracket
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CN201710208449.0A
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CN108652786A (en
Inventor
欧敬民
吴洪远
潘畅
阙亦云
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Shanghai Microport Longmai Medical Equipment Co ltd
XinHua Hospital Affiliated To Shanghai JiaoTong University School of Medicine
Original Assignee
Shanghai Microport Longmai Medical Equipment Co ltd
XinHua Hospital Affiliated To Shanghai JiaoTong University School of Medicine
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Priority to CN201710208449.0A priority Critical patent/CN108652786B/en
Publication of CN108652786A publication Critical patent/CN108652786A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes

Abstract

The invention provides a stent windowing device and a stent system, wherein the stent windowing device comprises a catheter and a guide wire, a side hole which is communicated with an inner cavity of the catheter is formed in the side wall of the catheter, the guide wire is placed in the catheter in a non-working state and extends out of the catheter through the side hole in the working state, the stent system comprises a covered stent and the stent windowing device, and the head end part of the guide wire extends out of the catheter through the side hole and is used for contacting with the covered stent to puncture the covered stent. The bracket windowing device is used for solving the problems that the existing windowing bracket needs foreign customization, has long customization period and high customization price and has limited application range, and is used for solving the problem that the I-type internal leakage occurrence rate is easy to occur by adopting a film covered bracket with standard specification in the chimney technology.

Description

Bracket windowing device and bracket system
Technical Field
The invention relates to the technical field of medical equipment, in particular to a bracket windowing device and a bracket system.
Background
With the improvement of the living standard of people and the deterioration of the industrial environment, abdominal aortic aneurysm (AAA: abdominal Aortic Aneurysm) has become one of the common arterial dilatation diseases threatening the survival of human beings. Clinical randomized controlled trials have found that complete AAA patients have a 5-year survival of 65% whereas ruptured AAA has a survival of only 41%. In 1991, parodi et al reported for the first time 21 cases of endovascular exclusion of abdominal aortic aneurysms, marking the entry of new phases of abdominal aortic aneurysm treatment. Literature shows that the success rate of the endovascular repair of abdominal aortic aneurysms (EVAR: endo-Vascular Aneurysm Repair) is high and the rate of relay opening is low. However, patients who are able to meet the EVAR anatomical criteria account for only 20% to 50% of the total. Some patients often have unacceptable EVAR due to too short a proximal neck and difficult stent anchoring. In addition, stent occlusion of the inferior mesenteric artery and the internal iliac artery openings can cause corresponding complications, mainly including intestinal ischemia, changes in sacral caudal and pelvic ischemia, paraplegia, and the like. In view of the above, a window bracket opening and chimney technology and the like have been developed.
The teaching of korean Jae Hyung Park in 1996 initiated the windowing technique to repair abdominal aortic aneurysms. The window bracket is formed by opening holes on the position of the endovascular graft, which is opposite to the opening positions of the internal organs such as the renal arteries, and can create enough proximal anchoring areas while keeping important internal organs, thereby effectively plugging the tumor body. However, the main popularization obstacle of the windowing technology is that the windowing bracket needs to be customized abroad, a period of about 2-3 months is needed, the price is high, and the customized windowing bracket is designed according to the size of foreigners and needs larger access blood vessels, so that part of the foreigners cannot be suitable for female patients in particular.
The chimney technology is to apply a covered stent or a bare metal stent between the covered branch vessel and the proximal aorta to anchor the aortic graft side by side in the process of embedding the aortic intracavity implant, when the important branches are required to be covered due to the operation, so as to achieve the purpose of protecting the covered branch blood supply. Compared with a windowed stent, the chimney technology has the advantages that the adopted covered stent is of standard specification, and a stent system does not need to be independently customized according to the anatomical form of an individual. However, it is reported in the relevant literature that chimney technology has a high incidence of type I endoleaks (i.e. the presence of stents in the branch vessels makes the aortic stents alongside them not fully attached to the arterial wall). In theory, the larger the number of the chimney supports is, the larger the supports are, and the possibility of internal leakage is also higher, so that the long-term curative effect and the long-term patency rate of the chimney supports are to be observed.
Disclosure of Invention
The invention aims to provide a stent windowing device and a stent system, which can form a window by opening a hole at a branch vessel corresponding to a covered stent after the covered stent is released in vivo so as to realize the retention or repair of the branch vessel, and solve the problems of high customization cost, long customization period, small application range, complex operation, I-type internal leakage risk of a smoke cooker stent and the like of the windowed stent.
In order to solve the technical problems, the invention provides a bracket windowing device, a side hole which is communicated with an inner cavity of a catheter is formed in the side wall of the catheter, a guide wire comprises a guide wire head end and a guide wire main body, the diameter of the guide wire main body is smaller than that of the catheter, and the maximum size of the cross section of the guide wire head end is smaller than the aperture of the side hole; the guidewire has opposite proximal and distal ends, and the guidewire head end is located at the distal end of the guidewire.
Further, the guidewire has opposite proximal and distal ends; the guidewire includes a tip portion disposed on the distal end of the guidewire and extending out of the catheter through the side hole.
Further, the tip portion has a tapered sharp edge.
Further, the end of the guide wire has a bend angle relative to the guide wire body, the bend angle being between 0 and 180 degrees.
Further, the guidewire body includes at least a core wire having opposite proximal and distal ends and a wire wrap wound around the core wire from the proximal end of the core wire in an axial direction of the core wire; the portion of the wire wrap extending beyond the distal end of the core wire forms the guidewire tip.
Further, the guidewire body further includes a safety wire disposed between the core wire and the wire wrap; the safety wire has opposite proximal and distal ends, the distal end of the safety wire extending to the guidewire tip.
Further, the spinneret end comprises a developing section, and the developing section is made of a material with developing performance.
Further, the number of the side holes is one or more, and the hole walls of the side holes are provided with materials with developing performance.
Further, the catheter at least comprises a catheter head end and a main body section, wherein the hardness of the main body section is larger than that of the catheter head end, the main body section is of a three-layer structure, at least one reinforcing layer is arranged between the outer layer and the inner layer of the main body section, and the strength of the reinforcing layer is higher than that of the outer layer and/or the inner layer.
Further, the present invention further provides a stent system, including a stent graft and a stent windowing device as described in any one of the above, wherein another portion of the guide wire extends out of the catheter through the side hole and is used for contacting the stent graft to puncture the stent graft to form a window.
The tectorial membrane support includes main part support and side branch support, the side support is through the window extends to the main part support outside.
The bracket windowing device and the bracket system have the following advantages:
the first, the invention of the bracket window opening device is used for solving the problems that the existing window opening bracket needs foreign customization, the customization period is long, the customization price is high and the application range is limited, and on the other hand, the invention is used for solving the problem that the I-type inner leakage is easy to cause by adopting the standard film covered bracket in the chimney technology. Specifically, the customized windowing bracket not only has long preparation period in the preoperative period, but also needs more auxiliary surgical instruments, but the bracket windowing device only windows on the conventional tectorial bracket, and the implantation process of the conventional tectorial bracket is relatively simple and the clinical application is mature, so that the application of the bracket windowing device shortens the preparation period of the operation, reduces the use amount of the auxiliary surgical instruments, saves the operation cost, simplifies the operation, and particularly, the conventional tectorial bracket can be suitable for general population, especially female patients, has higher applicability, thereby improving the treatment range of the operation treatment, especially improving the ratio of receiving EVAR in the abdominal aortic aneurysm interventional operation, and having good social effect.
The stent windowing device directly windows on the covered stent to establish a window matched with the branch vessel, and when the stent windowing device is used, the window is matched with the branch vessel, so that the blood supply of the branch vessel is ensured, and in the smoke range technology, the usage amount of the covered stent implanted into the branch vessel can be reduced, and the risk of I-type internal leakage of a patient after operation is reduced.
Thirdly, the stent windowing device provided by the invention can continuously use the conventional implantation and release method of the covered stent by using the windowing stent, so that the stent release operation difficulty is reduced, the learning time is shortened, the self time of an operation is shortened, the contrast agent dosage and the radiation are reduced, and the patient death rate in the operation period is reduced.
Fourth, the stent windowing device of the invention can perform windowing according to the pathological changes of patients when windowing the stent graft, has high flexibility, and forms a window with relatively accurate positioning with the branch blood vessel, thus being capable of establishing a good blood flow channel and effectively reducing the complications caused by unsmooth blood flow of the branch blood vessel.
Drawings
Fig. 1 is a schematic structural diagram of a bracket window opening device according to an embodiment of the present invention;
FIG. 2 is a cross-sectional view of a guidewire of a stent windowing device in accordance with an embodiment of the present invention;
FIG. 3 is a schematic view of a stent windowing device according to an embodiment of the present invention, in which a branch vessel to be reserved is implanted in a catheter;
FIG. 4 is a schematic view of a guidewire according to an embodiment of the present invention inserted into the catheter shown in FIG. 3 and the end of the guidewire extending out of the catheter through the side hole;
FIG. 5 is a schematic view of the directional opening of the spinneret end of the guidewire shown in FIG. 4 in an implanted stent graft;
FIG. 6 is a schematic cross-sectional view of a body section of a catheter in accordance with an embodiment of the present invention.
The reference numerals are explained as follows:
10-a bracket windowing device; 11-a catheter; 12-a guidewire; 111-side holes; 112-catheter head end; 113-a body section; 1131-an outer layer; 1132-inner layer; 1133-enhancement layer; 114-a control section; 115-diffusion stress tube; 121-a guidewire tip; 1210-tip portion; 122-core wire; 123-winding; 124-a security thread; 20-branching a blood vessel; 30-tectorial membrane stent.
Detailed Description
In order to make the contents of the present invention more clear and understandable, the bracket windowing device and the bracket system of the present invention will be further described with reference to fig. 1 to 6 of the accompanying drawings. Of course, the invention is not limited to this particular embodiment, and common alternatives known to those skilled in the art are also encompassed within the scope of the invention.
Next, the present invention will be described in detail with reference to the drawings, which are only for the purpose of detailing examples of the present invention, and should not be construed as limiting the present invention. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "proximal" generally refers to an end proximal to an operator and "distal" refers to an end distal from the operator. The same or similar reference numbers in the drawings refer to the same or similar parts.
The stent system of the present invention comprises a stent windowing device 10 and a stent graft 30, wherein the stent windowing device 10 is used for forming at least one window on the stent graft 30, and the window is used for aligning with the inlet of the branch vessel 20, so as to ensure the blood supply of the branch vessel 20 and avoid the complication caused by the occlusion of the branch vessel 20 by the stent on the main vessel.
Referring to fig. 1 to 5, fig. 1 is a schematic structural view of a stent windowing device 10 according to an embodiment of the present invention, fig. 2 is a cross-sectional view of a guide wire 12 of the stent windowing device 10 according to an embodiment of the present invention, fig. 3 is a schematic view of a catheter 11 of the stent windowing device 10 according to an embodiment of the present invention being implanted in a branch vessel to be preserved, fig. 4 is a schematic view of a guide wire 12 according to an embodiment of the present invention being inserted into the catheter 11 shown in fig. 3 and a guide wire end 121 being protruded out of the catheter 11 through a side hole 111, and fig. 5 is a schematic view of a guide wire end 121 of the guide wire 12 shown in fig. 4 being directionally perforated on a stent graft 30 implanted in a body.
As shown in fig. 1 to 5, the stent windowing device 10 comprises a catheter 11 and a guide wire 12, wherein a side hole 111 penetrating through the inner cavity of the catheter 11 is formed on the side wall of the catheter 11, when in use, the guide wire 12 is inserted into the catheter 11, a part of the guide wire 12 is arranged in the catheter 11, and the other part of the guide wire 12 can extend out of the catheter 11 through the side hole 111 for puncturing the corresponding position of the covered stent 30 (actually, only the covered film of the covered stent 30 is required to be punctured) at the position where the covered stent 30 of the abdominal aortic aneurysm is released and the branch vessel 20 are corresponding.
The usage principle of the bracket windowing device 10 of the present embodiment includes:
the first step: as shown in fig. 3, under conventional intervention, the catheter 11 is implanted into a human body by means of guidance of a DSA device, and the catheter head end 112 of the catheter 11 is inserted into a branch vessel 20 (the branch vessel 20 is, for example, a renal artery, an superior mesenteric artery, a peritoneal trunk, an aortic arch branch, a deep femoral artery, or the like) to be reserved; as shown in fig. 3, a common guide wire can be first placed into the branch vessel 20, so that the catheter 11 is positioned into the branch vessel 20 along the common guide wire, and the catheter head end 112 of the catheter 11 is bent and inserted into the branch vessel 20 at a certain angle, so that the side hole 111 of the catheter head end 112 corresponds to the opening position of the branch vessel 30, and the function of accurately positioning the opening position of the branch vessel 30 is achieved;
thereafter, the second step: as shown in fig. 4, the guidewire 12 is inserted into the catheter 11 and moved along the extension path of the catheter 11 until the guidewire tip 121 of the guidewire 12 reaches the side hole 111 of the catheter 11;
next, a third step: as shown in fig. 5, after the stent graft 30 is implanted, for example, through a femoral artery implantation procedure, and released after the stent graft 30 reaches a lesion site, (preferably, the implantation position of the stent graft 30 is monitored in real time by Digital Subtraction Angiography (DSA)), the window is established by piercing the stent graft 30 with the guide wire head end 121 extending out of the side hole 111 in the region of the stent graft 30 corresponding to the branched blood vessel 20, so as to realize directional perforation of the stent graft 30;
subsequently, the fourth step: retracting the guide wire 12 to the inside of the catheter 11, and retracting the guide wire 12 together with the catheter 11 from the human body;
finally, as an optional fifth step: after the guide wire 12 is completely withdrawn from the catheter 11, the guide wire is replaced for use, balloon dilation is performed along the guide wire at the window of the stent graft 30 to enlarge the window, or another stent graft is placed, which is used for implantation of the branched vessel 20 to establish a long-term reliable blood flow channel, as required. Specifically, the stent graft 30 comprises a main body stent and a side branch stent which are independent from each other, the side branch stent is implanted in the branch vessel 20 by extending out of the main body stent through the established window, and the guide wire and the balloon catheter or the stent delivery system are withdrawn after the blood flow channel is established.
After the above steps, a blood flow channel is established between the stent graft 30 and the branch vessel 20 to be reserved, so that complications caused by the blockage of the branch vessel 20 by the stent graft 30, such as intestinal ischemia, changes in sacral caudal and pelvic ischemia, paraplegia and the like caused by the blockage of the openings of the inferior mesenteric artery and the internal iliac artery, are avoided. Moreover, by creating a window over the stent graft in the main vessel (herein, the main vessel is correspondingly defined as the aorta and the branch vessel corresponds to the branch artery) relative to the smoke focus stent, the use of multiple rows of stent grafts can be avoided, enabling the stent graft in the aorta to achieve good adhesion to the arterial wall, reducing the risk of stent leakage.
Further, the number of the side holes 111 is not limited to one, and in practical application, may be plural, and windows corresponding to different branch vessels may be established on the stent graft 30 through different side holes 111. In order to reduce the cost and simplify the operation, it is preferable to set up different windows on the stent graft 30 through one side hole 111, specifically, the window with different positions and orientations can be conveniently and rapidly set up on the stent graft 30 by only adjusting the angle of the end 121 of the wire guide extending out of the side hole 111. It is apparent that the shape, size and opening direction of the side hole 111 are not particularly limited in the present invention, so that the threading of the spinneret end 121 can be facilitated.
Preferably, the catheter tip 112 has a developing property, for example, the catheter tip 112 includes a developing section made of a material having a developing property, and the optional metal developer is selected from barium sulfate (BaSO 4), bismuth oxide (Bi 2O 3), tungsten powder, or the like, so that the implantation position of the catheter 11 can be better tracked under the conventional interventional operation, for example, through DSA real-time monitoring. In one embodiment, the development section of the catheter tip 112 is directly machined from a material having development properties, and in other embodiments, the development section of the catheter tip 112 is coated with a layer of a material having development properties.
More preferably, the walls of the side holes 111 are developable to determine the position and orientation of the side holes to precisely establish a window in the stent graft 30. For example, a layer of a material having a high brightness development property, such as Pt-Ir alloy, ta metal, au metal, or the like, is coated on the wall of the side hole 111, and the coated portion may be a ring shape or a part of a ring shape, preferably a ring shape.
Further, the catheter 11 includes a body section 113 in addition to the catheter head end 112, the catheter head end 112 being connected to the distal end of the body section 113 in a bendable manner relative to the body section 113. In particular, the hardness of the main body section 113 is greater than that of the catheter head end 112, and the softness of the catheter head end 112 is utilized to well accommodate complex human anatomy while the supportability of the main body section 113 is utilized to better push the catheter. The catheter head 112 may have different curved configurations relative to the body section 113, such as Cobra 2 (matable to an Cobra catheter), RH (matable to a hepatic arterial catheter), etc., depending on the location of application.
In this embodiment, the catheter head end 112 and the body section 113 may have the same outer diameter, preferably 6F-12F.
Further, the catheter 11 further comprises a control portion 114 fixedly arranged at the proximal end of the main body section 113 and adapted to force the main body section 113 for movement, such as pushing the catheter 11 under the driving of the control portion 114 or twisting the catheter 11.
Still further, the catheter 11 further includes a diffusion stress tube 115 sleeved on the proximal end of the main body section 113 (the main body section 113 has opposite proximal and distal ends, the distal end of the main body section 113 is connected to the catheter head end 112), and the control portion 114 is fixedly disposed on the diffusion stress tube 115, and the diffusion stress tube 115 has a hardness less than that of the main body section 113. By the provision of the diffusion stress tube 115, it is facilitated to uniformly conduct the torsion or axial force received by the control portion 114 to the main body section 113.
In a preferred embodiment, as shown in fig. 6, the main body section 113 is a composite structure of at least three layers of materials, and at least one reinforcing layer 1133 is disposed between the outer layer 1131 and the inner layer 1132 of the main body section 113, where the reinforcing layer 1133 has a higher strength than the inner layer 1132 and the outer layer 1131. Optionally, the material of the inner layer 1132 is selected from polytetrafluoroethylene, polyamide-polyether block copolymer or other high polymer materials with low friction coefficient, and may be a combination of these materials. The material of the reinforcing layer 1133 is one or more selected from stainless steel (SUS 304, SUS 304V), nickel-titanium alloy, kevlar and nylon, and the reinforcing layer 1133 may be formed by a process of braiding or winding, wherein the reinforcing layer 1133 may be formed by stainless steel wire, nickel-titanium wire, kevlar fiber or nylon wire. The material of the outer layer 1131 is one or more of polyurethane and polyamide-polyether block copolymer. The outer layer 1131 of the present embodiment refers to a portion contacting human tissue, the inner layer 1132 refers to a portion contacting the guide wire, and at least one layer of reinforcing material is filled between the outer layer 1131 and the inner layer 1132, and the outer layer 1131 and the inner layer 1132 are not limited to the reinforcing material, but may be filled with the same material as the inner layer 1132 or the outer layer 1131. Whether the outer layer 1131 or the inner layer 1132, it is required that the outer wall of the outer layer 1131 and the inner wall of the inner layer 1132 be smooth, that is, have a relatively small friction coefficient, so that the pushing resistance of the guide wire 12 is reduced by the smoothness of the inner layer 1132, and the pushing resistance of the catheter 12 is reduced by the smoothness of the outer layer 1131 while avoiding damage to human tissues.
Next, referring again to fig. 2, the guide wire 12 includes a guide wire end 121 and a guide wire body, and the guide wire end 121 is connected to the distal end of the guide wire body in a bendable manner with respect to the guide wire body, preferably, the guide wire end 121 has a higher supporting strength than the guide wire body to smoothly pierce the stent graft 30. Preferably, the guide wire end 121 has developing property, and in particular, the guide wire end 121 includes a developing section, and the developing section of the guide wire end 121 includes a material having high brightness developing property. The guide wire head 121 is bent at an angle of between 0 and 180 ° relative to the guide wire body, for example, the guide wire head 121 shown in fig. 2 is initially set to bend at 180 ° relative to the guide wire body, i.e., a semicircular structure is formed.
In addition, the end of the spinneret end 121 has a certain sharpness to smoothly puncture the coating of the coating bracket 30. Optionally, the end of the guide wire head 121 is provided with a tip portion 1210 for puncturing the covering film, and the tip portion 1210 has a tapered sharp edge. The same or different coatings can be coated on the outer wall of the guide wire end 121 and the outer wall of the guide wire main body, and the materials of the coatings are hydrophilic coatings such as PVP, MA and the like, and hydrophobic coatings such as PTFE and the like.
In this embodiment, the guide wire body includes at least a core wire 122 and a wire winding 123, the wire winding 123 is wound around the core wire 122 in an axial direction of the core wire 122, and a portion of the wire winding 123 extending through a distal end of the core wire 122 forms a guide wire end 121. The wire winding 123 of the present embodiment is wound on the core wire 122 in a spiral manner.
Preferably, the guidewire body further includes a safety wire 124 disposed between the winding wire 123 and the core wire 122. The distal end of the safety wire 124 extends to a spinneret end 121, and in this embodiment, one end of the safety wire 124 is connected to a tip 1210.
The core wire 122 is in this embodiment of solid construction and has a hardness which is greater than the hardness of the wire winding 123, on the one hand by the high strength of the core wire 122 supporting the guide wire and on the other hand by the softness of the wire winding 123 protecting the human tissue. The material of the core wire 122 is selected from metal materials such as stainless steel (SUS 304, SUS 304V) or nitinol. The wire winding 123 is made of a metal material selected from stainless steel (SUS 304, SUS 304V), nitinol, gold, platinum, or tungsten. The material of the safety wire 124 is selected from stainless steel (SUS 304, SUS 304V), nickel-titanium alloy, gold, platinum, tungsten, or other metal materials.
The preferred embodiments of the present invention are described above, but not limited to the scope of the disclosure of the embodiments, for example, the stent windowing device of the present invention is not limited to be used for windowing a stent graft, but can also be used for reaming other stents, for example, enlarging the size of a hollowed-out structure on a stent, etc.
The bracket windowing device is used for solving the problems that the existing windowing bracket needs foreign customization, has long customization period and high customization price and has limited application range, and is used for solving the problem that the I-type internal leakage occurrence rate is easy to occur by adopting a film covered bracket with standard specification in the chimney technology.
Specifically, the customized windowing bracket has long preparation period before operation and needs more auxiliary surgical instruments, but the bracket windowing device only windows on the conventional tectorial membrane bracket, and the implantation process of the conventional tectorial membrane bracket is relatively simple and the clinical application is mature, so the application of the bracket windowing device shortens the preparation period of operation, reduces the use amount of the auxiliary surgical instruments, saves the operation cost, simplifies the operation, and particularly, the conventional tectorial membrane bracket can be suitable for general population, especially female patients, has higher applicability, thereby the treatment range of the operation treatment is improved, especially the ratio of receiving EVAR in the abdominal aortic aneurysm interventional operation is improved, and has good social effect.
In addition, the stent windowing device directly windows on the covered stent, establishes a window matched with the branch vessel, and when in use, the window is matched with the branch vessel, so that the blood supply of the branch vessel is ensured, and in the smoke range technology, the using amount of the covered stent implanted into the branch vessel can be reduced, and the risk of I-type internal leakage of a patient after operation is reduced.
In addition, the use of the stent windowing device enables the windowing stent to continuously use the conventional implantation and release method of the covered stent, reduces the difficulty of stent release operation, shortens the learning time, shortens the self time of operation, reduces the contrast agent dosage and the radiation, and reduces the patient death rate in the operation period.
Particularly, when the stent windowing device is used for windowing a covered stent, windowing can be performed according to the pathological change condition of a patient, the flexibility is high, and the formed window and the branch blood vessel are positioned accurately, so that a good blood flow channel can be established, and the complication problem caused by unsmooth blood flow of the branch blood vessel is effectively reduced.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims (7)

1. The bracket windowing device is characterized by comprising a catheter and a guide wire, wherein a side hole which is communicated with an inner cavity of the catheter is formed in the side wall of the catheter, the guide wire comprises a guide wire head end and a guide wire main body, the diameter of the guide wire main body is smaller than that of the catheter, and the maximum size of the cross section of the guide wire head end is smaller than the aperture of the side hole; the guide wire having opposite proximal and distal ends, the guide wire head end being located at the distal end of the guide wire; the catheter head end of the catheter is used for being inserted into a branch blood vessel, so that the side hole corresponds to the opening position of the branch blood vessel; the guide wire is used for being inserted into the catheter, and the wire guiding head end is used for extending out of the catheter through the side hole so as to puncture the covered stent to form a window in the area of the covered stent corresponding to the branch vessel; the guide wire comprises a tip part and is arranged at the head end of the guide wire; the tip portion having a tapered sharp edge; the wire guiding end is provided with a bending angle relative to the wire guiding main body, and the bending angle is 0-180 degrees.
2. The stent windowing device of claim 1, wherein the guidewire body comprises at least a core wire having opposite proximal and distal ends and a wire wrap wound around the core wire from the proximal end of the core wire in an axial direction of the core wire; the portion of the wire wrap extending beyond the distal end of the core wire forms the guidewire tip.
3. The stent windowing device of claim 2, wherein the guidewire body further comprises a safety wire disposed between the core wire and the wrap wire; the safety wire has opposite proximal and distal ends, the distal end of the safety wire extending to the guidewire tip.
4. The bracket windowing apparatus of claim 1, wherein the spinneret end comprises a development section made of a material having development properties.
5. The stent windowing device of claim 1, wherein the number of the side holes is one or more, and a material with developing property is arranged on the hole wall of the side hole.
6. The stent windowing device of claim 1, wherein the catheter comprises at least a catheter head end and a body section, the body section has a hardness greater than that of the catheter head end, the body section has at least a three-layer structure, at least one reinforcing layer is disposed between an outer layer and an inner layer of the body section, and the reinforcing layer has a strength higher than that of the outer layer and/or the inner layer.
7. A stent system comprising a stent graft and a stent windowing device as claimed in any one of claims 1 to 6, wherein the spinneret end of the guidewire extends out of the catheter through the side hole for contact with the stent graft to puncture the stent graft to form a window.
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