WO2021068421A1 - Cathéter spécial pour l'aspiration de thrombus à partir d'un vaisseau cérébral distal - Google Patents
Cathéter spécial pour l'aspiration de thrombus à partir d'un vaisseau cérébral distal Download PDFInfo
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- WO2021068421A1 WO2021068421A1 PCT/CN2019/130545 CN2019130545W WO2021068421A1 WO 2021068421 A1 WO2021068421 A1 WO 2021068421A1 CN 2019130545 W CN2019130545 W CN 2019130545W WO 2021068421 A1 WO2021068421 A1 WO 2021068421A1
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Images
Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
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- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
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- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
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- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
Definitions
- the invention relates to a surgical tool for preparing a brain tube, in particular to a patented catheter for cerebrovascular diseases.
- Cerebral infarction also known as ischemic cerebrovascular disease, is a disease caused by thrombosis, embolism, or other causes of insufficient blood supply in the cerebral blood vessels.
- the death toll from acute cerebrovascular disease in my country accounts for 36% of the total death toll, and it is one of the common diseases that seriously endanger the health of middle-aged and elderly people.
- Intravenous heavy tissue fibrinogen activator is a method approved by the US FDA for acute ischemic stroke, but due to the limited treatment time after symptoms appear, only a small number of patients receive treatment. In addition, the effect of intravenous treatment of large vessel occlusion is limited.
- Stent thrombus removal using minimally invasive interventional therapy to place the thrombus removal stent through a catheter at the thrombus site. After a few minutes, it will be combined with the thrombus to directly grasp the thrombus and pull the thrombus out of the cerebrovascular so that the occluded blood vessel can be recanned.
- stent thrombus removal also has its drawbacks.
- the stent thrombus removal needs to be operated through a micro-guide wire and the distal end of the micro-catheter. At the same time, the stent needs to pass through the thrombus. This requires a higher requirement for beginners, and the treatment cost is also relatively expensive.
- ADAPT advanced neurointerventional technology
- ADAPT technology can increase the recanalization rate and shorten the recanalization time, and the use of ADAPT technology is safe and effective, device-related complications are lower than stent removal, and symptomatic bleeding is zero.
- the existing thrombus suction systems on the market are represented by Navien catheters and Penumbra catheters.
- the current clinical data tells us that Navien and Penumbra also have many problems and cannot meet clinical needs.
- the middle layer of the Navien tube body is a spring structure, which does not have good pushing performance, and the distal end of the Navien catheter has poor flexibility, and it cannot reach the diseased location through the tortuous blood vessel path.
- the middle layer of the Penumbra catheter is also a spring structure, which lacks good force transmission performance, and the Penumbra has a small internal cavity and poor suction effect.
- the current thrombus aspiration catheters on the market cannot meet the clinical needs of ADAPT technology.
- the purpose of the present invention is to provide a cerebrovascular thrombus aspiration catheter with good flexibility, which can reach tortuous lesion positions and has a larger lumen. Effectively, it is convenient for doctors to operate and saves the time of thrombus aspiration operation.
- a catheter dedicated to aspiration of thrombus at the distal end of a cerebrovascular vessel which is composed of a catheter base, a stress relief tube and a tube body, the main part of the tube body Consists of three layers, inner layer, braided layer, and outer layer;
- the outer layer material is designed in segments, designed according to the physiological anatomy of the cerebral blood vessel, and according to the different segments of the blood vessel, providing corresponding flexibility; mainly using one or more of nylon 12, PEBAX, and TPU polyester materials to cooperate with each other production;
- the middle layer adopts a double-layer structure combining Braid and Coil.
- the braid layer is made of heat-treated 304 stainless steel flat wire material, consisting of 12 to 20 flat wires.
- the braid density is preferably 60PPI at the proximal end and 60PPI at the distal end. 80 to 100PPI; the woven shape is a mesh, the spiral layer is wrapped around the braided layer;
- the inner layer is made of PTFE material, and the wall thickness of the inner tube is 0.001; the tube body corresponding to the M and M2 sections at the top of the tube is composed of only the inner and outer layers; a spring is added at the distal end; the diameter of the spring wire is preferably 0.0015 inches, The pitch is preferably 0.0035 inches, and the material is preferably 304 stainless steel; the distal end is equipped with a C-shaped imaging ring; the top of the tube body is extended to the intracranial M1 or M2 section; the M1 or M2 section is directly inserted into the plug operation.
- the segmentation of the outer layer material of the catheter of the present invention is designed according to the physiological anatomical structure of the cerebral blood vessel, and provides corresponding flexibility and pushing performance according to different segments of the blood vessel, so that the catheter can effectively adapt to the vascular structure and facilitate the catheter to reach the diseased location. .
- the middle of this solution is a braided layer, and the middle layer adopts a double-layer structure combining a braid layer and a spiral layer (coil).
- the braided structure can provide good pushing performance and torsion performance for the catheter, and the spring layer can suck the thrombus. During the process, it provides good anti-negative pressure ability, which can reach the distal M2 segment (the middle cerebral artery surrounding segment) and has good suction performance at the same time.
- the outer layer material of the distal end of the catheter uses a polymer material with low hardness, which provides good flexibility for the catheter and facilitates the catheter to reach the diseased location.
- the inner layer is preferably PTFE material, and the wall thickness of the inner tube is 0.001", which meets the requirements of high temperature resistance, corrosion resistance, low friction coefficient, non-adhesion, and non-toxicity.
- the distal end of the catheter of this solution is a C-shaped imaging ring, which can provide good radial elasticity during the pushing process, and is convenient to pass through the tortuous cerebrovascular system.
- the C-shaped imaging ring design provides good radial tension, which is convenient for the thrombus to be sucked into the catheter.
- the length of the product is designed to meet the required vascular location according to different types of lesions, and the farthest to reach the distal M2 segment (the middle cerebral artery surrounding segment), in order to facilitate the identification of the product location, it needs to be under X-ray Visibility, especially the distal end must be clearly visible under X-rays.
- the specific segment design is shown in the following embodiments.
- the radiopaque material preferably uses barium sulfate, bismuth subcarbonate, etc. to be added to the outer layer material.
- the diameter of the distal end of the product should be suitable for the part of the blood vessel to be reached, and cannot exceed the diameter of the blood vessel reached.
- the product is designed with two outer diameters, one of which can reach the M2 segment (the middle cerebral artery surrounding segment), and the other The outer diameter can reach the M1 segment (the horizontal segment of the middle cerebral artery).
- the product tube body is designed in sections according to the anatomical structure of the cerebral blood vessel, and the characteristics of each section of the blood vessel are considered in the design to balance the appropriate length and hardness of each section of the product.
- the cerebrovascular anatomical diagram is as follows, including the extracranial segment of the internal carotid artery (C1), petrosal segment (C2), ruptured foramen segment (C3), cavernous sinus segment (C4), clinoid segment (C5), and ophthalmic artery segment (C6) , The posterior traffic section (C7), the horizontal section of the middle artery (M1), and the surrounding section of the middle artery (M2).
- the catheter In order to integrate the push capability and overall performance of the catheter, the catheter is divided into three layers, an inner layer, a braided layer, and an outer layer.
- the material hardness of the proximal end including the material hardness of the braided layer, PPI (woven density), the weaving method, and the selection of the material of the outer layer.
- the outer layer is made of nylon 12, PEBAX, TPU and other polyester materials.
- the middle layer adopts a double-layer structure combining Braid and Coil.
- the braid adopts heat-treated 304 stainless steel flat wire material.
- the braid density is preferably 60PPI (mesh per inch) at the proximal end to achieve better Supporting force, the distal end is preferably 80PPI (mesh per inch) in order to achieve better flexibility.
- the inner layer is preferably PTFE material, and the wall thickness of the inner tube is 0.001", which meets the requirements of high temperature resistance, corrosion resistance, low friction coefficient, non-adhesion, and non-toxicity.
- the catheter needs to have flexibility, especially the flexibility of the front-end bending material. At the same time, it is required to have good bending ability, torsion transmission ability, anti-bending ability, and good lubricity when passing through each segment of blood vessel.
- the product When the product is delivered through the catheter sheath, it should be smooth and without resistance.
- the micro-catheter When the product passes through the corresponding micro-catheter in the lumen, the micro-catheter is easy to transport without bending. At the same time, it is necessary to ensure that the lumen is large enough to satisfy the interventional operation when the outer diameter meets the requirements.
- the outer diameter has to be restricted, that is, the wall thickness is controlled.
- the inner diameter achieved by the present invention can meet the minimum breakthrough of 1.804 mm, and the maximum outer diameter can be controlled at 2.133 mm.
- the present invention breaks through the technical problem of adding Coil (spring) to the distal end E section (see Figure 3), and satisfies both flexibility and resistance to negative pressure suction.
- the spring wire The diameter is preferably 0.0015", the pitch is 0.0035", and the material is preferably 304 stainless steel.
- the above technical solution is further refined, and the inner diameter of the catheter is controlled within 1.804mm, and the maximum outer diameter can be controlled at 2.133mm.
- the catheter is made in sections, from the proximal end to the distal end in sequence A, B, C, D, E, F; the processes of each section are the same or different.
- the distal tip of the catheter should be round and smooth, and the distal tip is designed as the first segment.
- the outer layer is polyester elastomer and mixed nylon.
- the outer layers of the A section and the B section are made of nylon elastomer mixed with 20% Baso4; the outer layer of the C section is made of polyurethane TPU mixed with 20% Baso4, and the outer layers of the D, E, and F sections are made of a composite of polyether and polyamide. Material and 20% (BIO) 2 CO 3.
- the woven mesh knitted in the middle of D and E is 80PPI, and the size is 0.003"*0.001".
- the inner layer is dip coated with Dip Coating.
- the structure disclosed herein is suitable for establishing a thrombus aspiration guide tube combining distal access and thrombus suction in the treatment of cerebrovascular diseases.
- the structure has high blast pressure resistance, breaking strength, tensile strength, flexibility, torsion transmission ability, bending resistance, and good self-lubrication.
- Figure 1 is an anatomical diagram of cerebrovascular.
- Figure 2 shows the overall structure of the product.
- Figure 3 is a schematic diagram of a section of the tube body.
- Figure 4 is a schematic diagram of a molding needle.
- Figure 5 is a schematic diagram of the guide sheath.
- A, B, C, D, E, and F represent the segments from the proximal end to the distal end of the tube.
- proximal and distal refer to the direction along the longitudinal axis of the catheter, and the proximal end refers to The end of the catheter closer to the operator, the distal end refers to the end of the catheter closer to the patient.
- the method includes the following steps: the clinician shapes the tip of the catheter according to the position and condition of the patient's cerebrovascular disease: bend the shaping needle shown in Figure 4 to the desired angle, and be careful Put the catheter into the distal end of the catheter, steam the shaped needle and catheter together on steam for 30 seconds, immediately put the catheter shaped distal end of the catheter into normal saline for shaping, and then remove the shaped needle from the catheter.
- FIG. 1 shows the overall structure of the guiding catheter.
- Barium sulfate is preferably added to the proximal outer layer material, and bismuth subcarbonate is preferably added to the distal outer layer material.
- Figure 2 shows a schematic sectional view of the product and a cross-sectional view of the catheter body.
- the distal tip of the catheter should be smooth, and the distal tip is designed as the first segment;
- the diameter of the M1 section is 2.5 ⁇ 4.0mm, and the length is 12 ⁇ 30mm; there is a bifurcation angle of 90° to 120° from C7 to M1;
- the diameter of the blood vessel is small, and the catheter part of the M1 segment has the most tortuous paths; so it must have good flexibility, the catheter has a small radial force and is easy to bend, but it must have a certain push performance, so Design the second section of the distal end of the catheter;
- the horizontal part has a length of 15-25mm, the vertical part has a length of 6-15mm, and the included angle is about 100°.
- the included angle between C3 and C4 is about 120°;
- Segment C4 (cavernous sinus segment): from the upper petrolingual ligament along the horizontal line to the anterior bed, the diameter increases, and the anterior and posterior S-shaped and C-shaped, with varying degrees of tortuosity. Starting from C3, they are the posterior ascending segment, the horizontal segment, and the anterior segment. Ascending section, diameter 4 ⁇ 5.5mm;
- C5 segment (clinoid segment): the part between the distal dural ring and the proximal dural ring, with a diameter of 4 to 5 mm;
- C6 segment ophthalmic artery segment: the diameter is about 3.5 ⁇ 5mm, and the length is about 5 ⁇ 11mm, bending backward and upward;
- Section C7 (rear traffic section): 3.5 ⁇ 4.5mm in diameter
- C2 section In the carotid artery tube, it is divided into a vertical cranial section and a horizontal section.
- the vertical section is about 2-10mm
- the horizontal section is about 12-20mm
- the included angle is 90-100°.
- C1 section extracranial section: inner diameter 4 ⁇ 7mm, from bifurcation to petrous bone;
- section C1 The path of section C1 is relatively straight and easy to pass, but the catheter needs to have better push delivery, so it is the fifth section of the distal end.
- Femoral artery to left common carotid artery the maximum diameter of the end of the common artery is 6-8mm, and the maximum internal diameter of the beginning of the internal carotid artery is 4-6mm;
- the catheter product is designed as a three-layer structure inner layer, braided layer, and outer layer.
- the design requirements of the inner tube high temperature resistance, corrosion resistance, low friction coefficient, non-adhesion, non-toxic.
- PTFE is resistant to high temperature, low friction coefficient, non-adhesive, and has no adverse reactions as artificial blood vessels and organs implanted in the body. Therefore, our design scheme prefers the inner layer material to be PTFE.
- the middle layer of the medical guiding catheter is the core part of the whole product. It has a mesh structure made of braided wire and a coil (spring) structure that is wound. Its function is to make the catheter resistant to breaking and twisting, and at the same time to make it resistant to breaking and twisting. Obtain a certain degree of compliance and flexibility. Based on the above characteristics, 304 stainless steel meets the design requirements.
- round wires and flat wires are commonly used.
- the radial force of the round wires is smaller, and the flat wires can reduce the wall thickness and increase the inner cavity;
- E segment is braid
- Coil (spring) structure can enhance E segment’s anti-negative pressure capability.
- Outer layer material design The outer layer material of the guiding catheter determines its shape, hardness and friction with the intima of the blood vessel. Therefore, the material selection is easy to process, light, soft and tough, with good resilience and Good resistance to flexural fatigue, less mechanical performance loss under repeated deformation.
- polyester elastomers and mixed nylon can meet the above requirements.
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
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CN115054320A (zh) * | 2021-12-08 | 2022-09-16 | 上海心玮医疗科技股份有限公司 | 一种颅内取栓支架的输送系统 |
CN115192855A (zh) * | 2022-07-13 | 2022-10-18 | 适介医疗科技(广州)有限公司 | 导管塑形装置及塑形组件 |
EP4091657A1 (fr) * | 2021-05-20 | 2022-11-23 | Creganna Unlimited Company | Cathéter d'aspiration et système d'élimination de caillot |
CN115644990A (zh) * | 2022-12-09 | 2023-01-31 | 上海珩畅医疗科技有限公司 | 用于介入手术的抽吸导管 |
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CN110537956A (zh) * | 2019-10-09 | 2019-12-06 | 上海加奇生物科技苏州有限公司 | 专用于脑血管远端血栓抽吸的导管 |
CN112401976A (zh) * | 2020-12-05 | 2021-02-26 | 北京先瑞达医疗科技有限公司 | 一种血栓抽吸导管 |
CN113144377A (zh) * | 2021-04-22 | 2021-07-23 | 深圳麦普奇医疗科技有限公司 | 远端通路导引导管 |
CN115153711A (zh) * | 2022-06-15 | 2022-10-11 | 四川艾迈思生物医疗科技股份有限公司 | 一种颅内神经微导管 |
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CN115054320A (zh) * | 2021-12-08 | 2022-09-16 | 上海心玮医疗科技股份有限公司 | 一种颅内取栓支架的输送系统 |
CN115192855A (zh) * | 2022-07-13 | 2022-10-18 | 适介医疗科技(广州)有限公司 | 导管塑形装置及塑形组件 |
CN115644990A (zh) * | 2022-12-09 | 2023-01-31 | 上海珩畅医疗科技有限公司 | 用于介入手术的抽吸导管 |
CN115644990B (zh) * | 2022-12-09 | 2024-04-23 | 上海珩畅医疗科技有限公司 | 用于介入手术的抽吸导管 |
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