Nicking sheath tube

Abstract

The invention provides a nicking sheathing canal. The nicking sheathing canal comprises a tubular body with an inner cavity and a canal wall. The inner cavity can accommodate an instrument for applying expansion force; the pipe wall is provided with a plurality of hollowed-out seams, ribs and joints, wherein the ribs and the joints are formed by an array of the seams. The tubular main body has an initial state with an initial radial dimension and an expanded state which is increased relative to the initial radial dimension; certain sections of ribs which are arranged between two ends of the tubular main body and are fixedly connected with two sides of the tubular main body form a pressure focusing group unit; each of the joints and the ribs comprises a blade part; the pressure focusing group unit has a deflection form, so that the pressure application effect of the pressure focusing group unit on the hollow anatomical structure from point to line development is realized; in the expansion state, the joints have the lateral tipping action for forming the deflection state of the pressure focusing group unit, and the blade parts of the joints rotate around shafts which are not overlapped with the central axes of the joints and are far away from the initial state axis of the tubular main body. The nicking sheathing canal can be flexibly assembled with balloons of various sizes and specifications, and the pressure focusing group unit can achieve efficient force gathering nicking.

Description

Technical Field

[0001] The present invention relates to an interventional medical device, and particularly to a notched sheath tube. Background Art

[0002] In order to better treat the lesion site, especially severely calcified or fibrotic lesions, before performing peripheral and arteriovenous fistula treatments, sufficient pre-dilation of the lesion site is carried out to obtain a larger lumen diameter for better subsequent treatment. This has become the main research direction in the medical industry. The treatment method of using greater pressure or more focused pressure to fully open the stenotic lesion has become a development trend. Intervention strategies including ultra-high pressure balloons, cutting balloons, notched balloons, plaque rotational ablation, etc. focus on physically fragmenting methods to dilate the lesion. After the lesion is dilated, a drug balloon is used to assist in the treatment to achieve longer-term vascular patency.

[0003] Currently on the market, the types of peripheral special balloons include cutting balloons, notched balloons, spine balloons, papillary balloons, constrained balloons, etc.; the domestic and foreign R & D enterprises involved include Boston Scientific, Bard, Spectranetics, Ev3 / Medtronic and other enterprises. In the above-mentioned prior art, the blade / notched wire / constrained structure needs to be fixed to the balloon catheter by welding or bonding; thus, in different lesion sites / lumens, it is often necessary to equip peripheral special balloon products with different model specifications / sizes, which greatly increases the treatment cost for patients; in addition, in the above-mentioned prior art, the process is relatively complex, the production process involves more than 10 steps, and the cost of a single peripheral special balloon product is high. Currently, these special balloons have the following problems:

[0004] 1) The existing structure in which a similar longitudinal blade is firmly adhered to the balloon is generally considered the most effective structure for cutting plaques or fibers, but this structure is not flexible enough and usually cannot reach and treat very tortuous lesions because the balloon diameter of the products with such a structure is generally small and the length is short. In addition, there is a risk of blade or notched component detachment in the way of inlaying or bonding blades and notched components on the balloon surface through special processes.

[0005] 2) The existing structure uses a spiral scoring wire wrapped around the periphery of the balloon. When expanded, the structure produces a spiral scoring groove at the lesion. However, in the actual implementation process, as the scoring balloon expands, the spiral cutting method is more likely to become uncontrolled, and the elastic recovery of the blood vessels after surgery is poor. In addition, the spiral scoring wire also has the problem of limiting the degree of balloon expansion. The existing multi-guide wire scoring balloon is to evenly arrange one or more straight scoring wires on the balloon surface along the longitudinal direction of the balloon, so that longitudinal scoring grooves can be produced. However, the scoring effect of this structure is related to the number of wires. The more wires there are, the better the cutting effect. However, when the number of wires is greater than 3, the guide wires are prone to entanglement, so the actual application effect is not very ideal.

[0006] 3) If these special balloons are drug-loaded balloons, when using drug balloons to treat lesions, if the drug falls off during the delivery process, it may damage the peripheral nerves under the action of blood flow flushing. At this time, if a notched sheath is used as an auxiliary delivery device, nerve damage caused by blood flow flushing during drug delivery can be avoided. In addition, it can also be used as an auxiliary device for targeted release of drug balls to increase the utilization rate of drugs.

[0007] In summary, existing cutting or scoring balloons have problems such as poor structural stability of the cutting or scoring components on the balloon surface, or restricting balloon expansion, which results in less than ideal scoring effects, leading to poor treatment effects and potential safety hazards. When these balloons are drug-loaded balloons, the drugs may fall off during delivery and damage the peripheral nerves, resulting in nerve damage.

[0008] Existing patent publications: US Patent Publication No. US8992553B2 (named Cutting balloon assembly and method of manufacturing thereof) discloses a cutting balloon assembly, including a delivery catheter, an expandable balloon mounted on the distal end of the catheter, and a scoring net arranged around the expandable balloon. In the cutting balloon assembly, both ends of the scoring net are fixed to the catheter / balloon, so it is not flexible or compatible with the treatment of lumens of various sizes. In addition, in the cutting balloon assembly, the scoring net contacts the lumen wall over a large area, which is not conducive to focusing the pressure and increasing the scoring effect.

[0009] Therefore, it is necessary to design a new lesion expansion device that can be used in lumens of various sizes, has strong compatibility, simple process, and high efficiency of force focusing and scoring (for example, changing from line pressure focusing to point pressure focusing). Summary of the invention

[0010] In view of the above-mentioned disadvantages of the prior art, the object of the present invention is to provide a notched sheath tube, which on the one hand solves the problem in the prior art that different models / sizes of peripheral special balloon products need to be replaced in various lumen scenarios, and on the other hand solves the problem that the traditional notched grid cannot reduce the pressure acting surface in the longitudinal direction of the hollow anatomical structure (that is, it cannot achieve that the pressure acting area applied to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular main body, or it cannot achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line).

[0011] To achieve the above object and other related objects, the present invention is realized by including the following technical solutions.

[0012] In the first aspect of the present invention, a notched sheath tube is provided, which includes a tubular main body having an inner cavity and a tube wall; the inner cavity can accommodate an instrument for applying an expansion force; there are a number of hollowed-out slits on the tube wall, as well as ribs and nodes formed by an array of the slits; the tubular main body has an initial state with an initial radial dimension and an expanded state with a radial dimension increased relative to the initial radial dimension; between the two ends of the tubular main body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; both the node and the rib include a blade part; the pressure focusing group unit has a deflection form to achieve that the pressure acting area applied by the blade part to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular main body, or to achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line; in the expanded state, the node has a lateral tipping action to form the deflection form of the pressure focusing group unit, and the blade part of the node rotates around an axis that does not coincide with the central axis of the node and moves away from the axis of the initial state of the tubular main body.

[0013] In the second aspect of the present invention, another notched sheath tube is provided, which includes a tubular main body having an inner cavity and a tube wall; the inner cavity can accommodate an instrument for applying an expansion force; there are a number of hollowed-out slits on the tube wall, as well as ribs and nodes formed by an array of the slits; the tubular main body has an initial state with an initial radial dimension and an expanded state with a radial dimension increased relative to the initial radial dimension; between the two ends of the tubular main body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; one side of the pressure focusing group unit includes a blade part; the pressure focusing group unit has a deflection form to achieve that the pressure acting area applied by the blade part to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular main body, or to achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line; in the expanded state, the pressure focusing group unit has a local tipping action towards one side of the node and around an axis other than the central axis of the node to form a deflection form exposing the blade part.

[0014] The third aspect of the present invention provides another notched sheath tube, which includes a tubular body having an inner cavity and a tube wall; the inner cavity can accommodate an instrument for applying an expansion force; the tube wall has a plurality of hollowed-out slits, as well as ribs and nodes formed by an array of the slits; the tubular body has an initial state with an initial radial dimension and an expanded state with a relatively increased radial dimension; between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; one side of the pressure focusing group unit includes a blade part; in the expanded state, the pressure focusing group unit has a deflection form that tends to the node side and flips around a non-node central axis; the pressure focusing group unit in the deflection form is used to achieve that the pressure acting area applied by the blade part to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or is used to achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line.

[0015] The fourth aspect of the present invention provides another notched sheath tube. A notched sheath tube includes: a tubular body having an inner cavity extending axially and a tube wall; a plurality of hollow slit arrays formed on the tube wall and distributed circumferentially and longitudinally, defining alternately connected ribs and nodes; the tubular body has a first radial dimension in the initial state and an expanded state that can be expanded to a second radial dimension; at least one pressure focusing group unit is composed of a node and the ribs fixedly connected to both sides thereof; one side of the pressure focusing group unit includes a blade part; in the expanded state, the pressure focusing group unit has a deflection form that tends to the node side and flips around a non-node central axis, so that the blade part forms a radially protruding structure; the protruding structure is configured to: achieve that the pressure acting area applied by the blade part to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line.

[0016] The fifth aspect of the present invention provides another notched sheath tube, which includes: a tubular body having an inner cavity and a tube wall with a hollow slit array, and the slit array forms alternately arranged ribs and nodes; the tubular body has a first radial dimension in the initial state and a second radial dimension in the expanded state; at least one pressure focusing group unit is composed of a node and the ribs fixedly connected to both sides thereof; one side of the pressure focusing group unit includes a blade part; the pressure focusing unit is configured to: in the expanded state, the pressure focusing group unit has a local tipping action that tends to the node side and around a non-node central axis to form a deflection form exposing the blade part;

[0017] The deflection form includes at least one feature selected from the following group:

[0018] (a) The blade part forms a wavy profile with a greater radial height in the middle than at both ends;

[0019] (b) The ribs where the blade parts of adjacent pressure focusing units are located are alternately connected to the ribs where the non-blade parts are located to form a continuous longitudinal arrangement;

[0020] (c) The deflected morphology of the scored sheath produces a longitudinally distributed cyclic pressure gradient on the hollow anatomical structure.

[0021] In some embodiments of any of the above-mentioned scored sheaths, the ribs where the blades of some adjacent pressure focusing units are located are alternately connected with the ribs where the non-blade portions are located, so that the pressure focusing group units are arranged longitudinally to form pressure focusing row units; in the deflected form, the distance between the blade of the pressure focusing row unit and the axis of the tubular body has a periodic change in the longitudinal direction.

[0022] In some further embodiments of the scored sheath described above, some pressure focusing row units are arranged along the circumferential direction to form a scored segment with a longitudinal length on the wall of the tubular body.

[0023] In some embodiments of any of the above-mentioned scored sheaths, the device applying the expansion force includes one or a combination of a balloon dilatation catheter, a drug-coated balloon dilatation catheter, a braided balloon dilatation catheter, and an expansion stent; the scored sheath can assist or cooperate with the device to expand the hollow anatomical structure; the device applying the expansion force is non-fixedly matched with the scored sheath.

[0024] In some embodiments of any of the above-mentioned scored sheaths, a non-expanded region with a relatively fixed radial dimension value is disposed near the distal end of the tubular body, and the non-expanded region is used for one end of the radial limiting rib.

[0025] In some further embodiments of the notched sheath described above, the non-expanded region has a hollow cavity, through which a guide wire can be tracked to enter a lesion in a hollow anatomical structure; and the non-expanded region has a smooth, developable distal end.

[0026] In some embodiments of any of the above-mentioned notched sheaths, a slender wire is fixedly connected to the proximal end of the tubular body for pulling and retracting the notched sheath; or, a slender hypotube is fixedly connected to the proximal end of the tubular body for pulling and pushing the notched sheath.

[0027] In some embodiments of any of the above-mentioned scored sheaths, an instrument introduction region is deployed near the proximal end of the tubular body; the instrument introduction region is used to guide an instrument that applies an expansion force into the inner cavity of the tubular body.

[0028] In some further embodiments of the scored sheath described above, the instrument introduction area includes a manifold unit and a transition seam; the manifold unit is used to guide the instrument into the inner cavity of the tubular body, and the transition seam is used to guide and transition the expansion trend of the instrument introduction area to the distal side of the tubular body; the manifold unit has a shape that converges 2 or more ribs into 1 rib; some transition seams extend toward the distal side of the tubular body to the nodes of the pressure focusing group unit.

[0029] In some embodiments of the notched sheath described above, the instrument introduction region includes an inclined opening that forms an inclined angle with the axis of the tubular body.

[0030] In some embodiments of the notched sheath described above, near the proximal side of the instrument introduction region, a slit is deployed where one end slit is larger than the other end slit.

[0031] In some embodiments of any of the notched sheaths described above, a drug coating is deployed on the wall of the tubular body.

[0032] In some embodiments of any of the notched sheaths described above, the notched sheath is intended for the dilation of stenotic blood vessels, including stenosis in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infra-popliteal artery, renal artery; or is intended for the adjuvant treatment of stenosis of autologous and artificial arteriovenous dialysis fistulas.

[0033] This application provides a notched sheath that can be flexibly assembled with balloons of various sizes and specifications, and the pressure focusing group unit can achieve efficient force concentration for notching; it has the effects of being applicable to lumens of various sizes and specifications, having strong compatibility, and efficient force concentration for notching; it can solve the problem that the traditional notched grid cannot reduce the pressure acting surface longitudinally on a hollow anatomical structure, and realize that the pressure acting area applied to the hollow anatomical structure gradually increases longitudinally on the tubular body, or realize the pressure application effect of the pressure focusing group unit on the hollow anatomical structure developing from a point to a line. The ingenious topological geometric structure design forces the blade part of the node to rotate around an axis that does not coincide with the central axis of the node (that is, the pressure focusing group unit has a tendency to one side of the node and flips around a non-node central axis), which can improve the stability / reliability of the flipping of the pressure focusing group unit, the fatigue resistance of multiple flips, the controllability of the flipping behavior / action, and the controllability of the flipping angle / deflection angle; and after the dilation force applied by the dilation instrument (such as a balloon catheter) to the notched sheath is removed, the repeated stability, controllability, and resilience performance of the pressure focusing group unit returning from the deflected state to the initial state; and during the dilation process of the notched sheath, improve the stability of the chain flipping of the series of pressure focusing row units. Description of the Drawings

[0034] Figure 1 Shown is a three-dimensional structural schematic diagram of an embodiment of the notched sheath 1000 of the present invention.

[0035] Figure 2 Shown is a partial two-dimensional plane unfolded structural schematic diagram of the notched section 1200 in the natural state with the feature of side-turning ribs in the same direction of the present invention.

[0036] Figure 3 Shown is a partial physical diagram of the notched section 1200 with the notched sheath 1000 sleeved on the balloon and in the initial state 501.

[0037] Figure 4Partial physical diagram of the scored section 1200 of the scored sheath tube 1000 sleeved on the balloon and in the transition state 508

[0038] Figure 5 Partial physical diagram of the scored section 1200 of the scored sheath tube 1000 sleeved on the balloon and in the flipped state 509.

[0039] Figure 6 Shown as Figure 5 Schematic diagram of the shape and position of each rib in the transverse section when the pressure focusing group unit 1400 is in the deflected shape.

[0040] Figure 7 Physical diagram of the scored sheath tube 1000 in the deflected shape of the pressure focusing group unit 1400.

[0041] Figure 8 Physical diagram of the deflected shape of the pressure focusing group unit 1400 arranged longitudinally to form a pressure focusing row unit.

[0042] Figure 9 Physical diagram of the deflected shape of the pressure focusing group unit 1400 on the balloon.

[0043] Figure 10 Schematic diagram of the deduction that the distance between the rib of the pressure focusing row unit and the axis of the tubular main body changes periodically longitudinally.

[0044] Figure 11 Schematic diagram of the distal local structure of a scored sheath tube.

[0045] Figure 12 Schematic diagram of the proximal local structure of a scored sheath tube.

[0046] Figure 13 Shown as Figure 1 Assembly schematic diagram of the scored sheath tube and the balloon catheter.

[0047] Figure 14 Schematic diagram of the local two-dimensional plane unfolding structure of another scored sheath tube 2000 of the present invention.

[0048] Figure 15 Schematic diagram of the deflected shape after expansion of the expandable part of the scored sheath tube 2000.

[0049] Figure 16 Schematic diagram of the local deflected shape structure with the pressure focusing unit 1600 and the pressure support unit 1700 longitudinally distributed on the same rib.

[0050] Figure 17 Schematic diagram of the local deflected shape structure where the rib flipping directions at different node units are opposite to each other

[0051] Figure 18 It shows a partial deflection morphological structure diagram in which the rib parts on both sides at the node unit are folded, flipped / deflected.

[0052] Figure 19 Shown as Figure 15 A diagram showing the morphology and position of each rib in the transverse section when in the deflected form.

[0053] Figure 20 It shows a three-dimensional structure diagram of an open-loop thrombus removal stent in the prior art.

[0054] Figure 21 It shows a schematic diagram of the area relationship between the gap and the ribs when the natural state of the introduction structure is unfolded flat.

[0055] Figure 22 It shows a flat unfolded diagram of the first form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0056] Figure 23 It shows a flat unfolded diagram of the second form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0057] Figure 24 It shows a flat unfolded diagram of the third form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0058] Figure 25 It shows a flat unfolded diagram of the fourth form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0059] Figure 26 It shows a flat unfolded diagram of the fifth form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0060] Figure 27 It shows a flat unfolded diagram of the sixth form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0061] Figure 28 It shows a flat unfolded diagram of the seventh form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0062] Figure 29 It shows one of the three-dimensional schematic diagrams of the seventh form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0063] Figure 30 It shows the second three-dimensional schematic diagram of the seventh form of the progressive introduction structure for assisting rapid exchange devices in the present invention.

[0064] Figure 31Schematic diagram of the bifurcated unit structure Figure One 。

[0065] Figure 32 Schematic diagram of the bifurcated unit structure Figure Two 。

[0066] Figure 33 Schematic diagram of the transition seam structure in the progressive introduction structure

[0067] Figure 34 Schematic diagram of the seam structure that is not interconnected / communicated with the main seam of the cage-like outer skeleton in the progressive introduction structure

[0068] Figure 35 Schematic diagram of the expanded state of the progressive introduction structure

[0069] Figure 36 Schematic diagram of the deflection form of the scoring unit 500 in a rapid exchange scoring sheath of the present invention

[0070] Figure 37 Schematic diagram of the three-dimensional structure of a rapid exchange scoring sheath of the present invention

[0071] Figure 38 Schematic diagram of the balloon catheter structure adapted to the rapid exchange scoring sheath

[0072] Figure 39 Schematic diagram of the three-dimensional structure of a peripheral vascular scoring catheter of the present invention

[0073] Figure 40 Schematic diagram of the three-dimensional structure of a scoring section having protrusions or teeth 600 of the present invention

[0074] Figure 41 Schematic diagram of the height of the scoring unit 500 after flipping of the present invention

[0075] Figure 42 Schematic diagram of the three-dimensional structure of the balloon introducer tube 700 used in conjunction with the peripheral vascular scoring catheter of the present invention

[0076] Figure 43 Schematic diagram of the scoring method in which the pressure focusing unit or pressure focusing group unit of the present invention gradually forms a line from points

[0077] Figure 44 Partial physical diagram of the scoring section 1200 when the scoring sheath tube 3000 of the present invention is in the initial state 501

[0078] Figure 45 Partial physical diagram of the scoring section 1200 when the scoring sheath tube 3000 of the present invention is in the flipped state 509

[0079] Figure 46 Shown as Figure 45 Schematic diagram of the local two-dimensional planar unfolding structure of the notch segment 1200 with directional / controlled rollover of the medium pressure focusing unit.

[0080] Figure 47 Shown as the schematic diagram of the local two-dimensional planar unfolding structure of the introduction structure 3300 where the notch sheath tube 3000 of the present invention extends away from the notch segment 1200 towards the proximal end of the tubular body.

[0081] Figure 48 Shown as the schematic diagram of the local two-dimensional planar unfolding structure of the introduction structure 3300 with the stability enhancement unit 3400.

[0082] Figure 49 Shown that the present invention also provides an introduction structure 2300 different from 1300 and 3300.

[0083] Figure 50 Shown as the schematic diagram of the node structure of the pressure focusing unit 1400. Detailed implementation manners

[0084] The following specific embodiments illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0085] Please refer to Figures 1 to 50 . It should be noted that the structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those skilled in the art to understand and read, and are not used to limit the limited conditions for the implementation of the present invention. Therefore, they do not have technical essential meanings. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the effects that the present invention can produce and the purposes that can be achieved, should still fall within the scope that the technical content disclosed by the present invention can cover. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" cited in this specification are only for the convenience of clear description and are not used to limit the scope for the implementation of the present invention. The change or adjustment of their relative relationships, without substantial change in the technical content, should also be regarded as the scope within which the present invention can be implemented.

[0086] The term "expansion performance" in this specification refers to the ability of medical devices (such as the notched sheath, progressive introduction structure, and rib described below) to smoothly expand and maintain their structural integrity and functionality under predetermined conditions during use. The key parameters of expansion performance include: 1) Expansion ratio: It refers to the ratio of the maximum diameter of the medical device after expansion to its initial diameter. A high expansion ratio means that the device can adapt to a larger diameter change; 2) Expansion uniformity: It refers to whether each part of the device can expand evenly during the expansion process, avoiding local over-expansion or deformation; 3) Force transmission efficiency: It refers to whether the force applied to the device can be evenly transmitted to each part to ensure the smoothness of the expansion process; 4) Rebound performance: It refers to whether the device can quickly return to its original state after expansion, especially in the case of multiple expansions and contractions.

[0087] In this application, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator; the longitudinal direction is the axial length direction of the notched sheath; the circumferential direction is the direction around the axis of the notched sheath for one circle.

[0088] Currently on the market, the types of peripheral special balloons include cutting balloons, notched balloons, spiky balloons, papillary balloons, constrained balloons, etc. The blades / etching wires / constraint structures of these special balloons need to be welded or bonded to the balloon catheter to form an integral and inseparable or detachable functional component; such an integral and inseparable or detachable functional component can only adapt to multiple lumen treatment scenarios by replacing functional components of different models / specifications / sizes; in other words, the integral and inseparable or detachable peripheral special balloons do not support multiple lumen treatment scenarios. In addition, some special balloons have poor ability to pass through tortuous blood vessels. To solve the problem of multi-specification and multi-size compatibility of peripheral special balloons, after extensive and in-depth research, the applicant proposed a solution for flexible replacement of the blade / etching wire / constraint structure: the notched sheath 1000 / 2000 that is split from the balloon catheter, and the notched sheath 1000 / 2000 mostly presents a cage shape in most scenarios; on the one hand, it solves the problem in the prior art that different models / specifications / sizes of peripheral special balloon products need to be replaced in multiple lumen scenarios, and on the other hand, it solves the problem that the traditional notched grid cannot reduce the pressure acting surface longitudinally on the hollow anatomical structure (it is hoped that the pressure acting on the hollow anatomical structure longitudinally is a progressive notch formed by several points gradually extending into a line, such as Figure 43 shown: the progressive notch line 800 formed by several points 801 gradually extending into a line, realizing that the pressure acting area on the hollow anatomical structure gradually increases longitudinally in the tubular main body, or realizing the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure from point to line).

[0089] To achieve the functions of the notched sheath tube mentioned above, there are usually two challenges: one is the structural design of the notched section 1200; the other is the design of the rapid exchange structure 1300.

[0090] Regarding the structural design of the notched section of the notched sheath tube: By exchanging the inflation and expansion of balloons 200 with different size specifications (such as length / size), the diseased area can be dilated at low pressure to restore blood circulation, achieving the purpose of multiple uses of one sheath. The structure of the notched section 1200 is the key structure for the notched sheath tube to achieve safe and efficient notching or cutting functions. Through the special size design of the ribs and nodes 1230, the ribs 1220 of the notched sheath tube are induced to become unstable during expansion. After becoming unstable, the ribs 1220 will be more likely to deform in the direction of the least resistance, and then form a deflection morphology 1400 / 1600 of lateral turning in the same direction or folding and lateral turning on both sides (as Figure 5 and Figure 18 shown); compared with the non-deflected ribs, these ribs / nodes with the deflection morphology 1400 / 1600 can further reduce the pressure acting surface on the inner wall of the hollow anatomical structure (realize that the pressure acting area applied to the hollow anatomical structure gradually increases in the longitudinal direction of the tubular main body, or realize the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure from point to line), so as to achieve the purpose of concentrated force notching / cutting; especially the deflection morphology 1400, which can gradually form a progressive notching line of several points extending into a line in the longitudinal direction of the hollow anatomical structure. As Figure 43 shown: A progressive notching line 800 formed by several points 801 gradually extending into a line can notch more efficiently and controllably compared with traditional blades / notching wires.

[0091] As Figures 2 to 9 shown, regarding the formation / generation of the deflection / turning / lateral turning morphology of the pressure focusing group unit 1400 (the structure usually includes the node 1230, the ribs 1224, 1225, 1226, 1227 fixedly connected to the node 1230; and the edge 506 for applying shear force / pressure to the hollow anatomical structure): As Figure 2 and Figure 50 shown, the slit 1210 of the notched section 1200 is distributed indirectly; ribs 1220 are fixedly connected to both sides (the node restraint side 12304 and the node restraint side 12305) in the longitudinal direction (the length direction of the notched section 1200) of the node 1230; the node central axis 12303 is defined as the axis between the two sides (the node free side 12301 and the node free side 12302) of the node 1230 where the ribs are not fixedly connected. As Figure 3As shown, before using the notched sheath 1000, through an on-site assembly operation, the notched sheath 1000 is sleeved on the unfilled balloon 200 (on-site assembly); at this time, the slit 1210 of the notched sheath 1000 presents a natural form gap 12101 because the rib strips on both sides of the node 1230 (such as the rib strips 1224, 1225, 1226, 1227 fixed to the same node 1230) are not radially expanded by the balloon 200; at the same time, both sides of the pressure focusing group unit 1400 (the notched section 1200 usually has a plurality of pressure focusing group units arranged circumferentially, such as 1410, 1420, 1480) have a tendency to conform to the circumferential smoothness of the balloon 200 (that is, to maintain the original natural state / form / morphology of the notched sheath 1000); this state is defined as the initial state 501 of the notched sheath 1000. In the initial state 501, the blade part 506 is usually received (or hidden) in the natural form gap 12101. When the balloon 200 is gradually filled, as the diameter of the balloon body gradually increases and exceeds the pipe diameter size of the notched sheath 1000 (notched section 1200) in the natural form (radially expanded by the balloon 200); the pressure focusing group unit 1400 of the notched section 1200 successively experiences: a transitional state 508 without flipping / deflecting / rolling over, and a deflected / rolled-over state 509 with a deflected form / morphology after flipping / deflecting / rolling over. As Figure 4 shown, in the transitional state 508 where the pressure focusing group unit 1400 does not flip, the rib strips store energy for the node, enabling it to have a tendency to flip; the fixed connection area of the node ( Figure 9In the area where the arrows are located on both sides of the slit 1210, there is a tendency to stretch outward along the circumferential direction (the two free sides 12301 / 12302 of the node); therefore, at the initial stage of expansion, the node remains circumferentially stationary, and the radial expansion causes the shape of the slit to gradually transition to a rhombus-like shape, and the length of the notched sheath slightly shortens; during this process, under the radial expansion applied by the balloon 200 and the constraint of the structure of the notched section 1200, the ends of the ribs (1224, 1225, 1226, 1227) far from the end fixed to the node 1230 gradually undergo relative displacement (deviating from the original gap 12101 maintaining the natural shape), thereby forming / generating a transitional shape gap 12102 (the shape of the transitional shape gap 12102 is usually similar to an olive shape); the development of this relative displacement continues until the flipping tendency of the node overcomes the tendency to maintain the circumferential smoothness of the balloon 200, causing the pressure focusing group unit 1400 to flip / deflect / roll over. In the transitional state 508, the blade part 506 (still / always) is received in (or hidden in) the transitional shape gap 12102. The shape and size of the transitional shape gap 12102 further develop and expand as the diameter of the balloon continues to expand; this means that the bending deformation of the ribs along the length direction further intensifies (that is, the force exerted on the node by the end of the rib fixed to the node further increases); in the area where the node 1230 is fixed to the ribs (1224, 1225, 1226, 1227) (the area where the arrows are located on both sides of the slit 1210), stress concentration / stress surge occurs; in addition, one node 1230 is fixed to 4 ribs at the same time (rib 1224, rib 1225, rib 1226, rib 1227), so there are 4 fixed areas on both sides of the node (the fixed areas between the node and the rib ends); at a certain moment or during a certain period of time, the stress concentration level / stress surge degree of these 4 fixed areas may not be the same; this series of changes (including structural shape changes and structural mechanics changes) trigger local instability of the node (such as one side 12302 of the node lifting away from the balloon surface 201) to relieve redundant stress, promoting plastic deformation of the structure shape of the pressure focusing group unit and accumulating strain energy. The forces at both ends of the node are transformed into a tilting moment as the node 1230 becomes unstable, causing the node to flip / roll over (for example, using one side 12301 of the node as a pivot (this pivot usually does not coincide with the central axis 12303 of the node), and the other side 12302 opposite to the pivot lifts away from the balloon surface 201 ( Figure 5 in the arrow direction), forming as shown in Figure 5 and Figure 6 the deflected shape of the exposed blade part 506 of the pressure focusing group unit 1400, driving the ribs on both sides to flip, and generating a chain reaction, (starting from the flipping of one node initially, after the chain reaction, it develops into the flipping of all the pressure focusing group units 1400 covered by the length of the balloon, as shown in Figure 7 ), causing all parts of the entire notched section 1200 to flip. As shown in Figure 5In the deflection / tilt state 509 of the pressure focusing group unit 1400 shown, the blade part 506, from its original received / hidden state (during the initial state 501 and the transition state 508), is forced to rotate around an axis that does not coincide with the node central axis and move away from the axis of the initial state of the tubular body, and is gradually exposed; in other words, the pressure focusing group unit 1400 tends towards the node side and makes a local tilting movement around a non-node central axis to form a deflected shape that exposes the blade part 506; in this state, the blade part 506 of one pressure focusing group unit (such as 1410) and the non-blade part 507 of another pressure focusing group unit (such as 1420), from their original side-by-side state facing each other (during the initial state 501 and the transition state 508), are forced to gradually move apart in space (i.e., change to a non-side-by-side state facing each other), forming a deflected shape gap 12103 (different in morphology from the transition shape gap 12102, where the two boundary rib strips change from the originally side-by-side blade part 506 and non-blade part 507 to the inner wall surface 510 and the outer wall surface 511 that are basically facing each other), so as to restore the structural mechanics of the system to balance. The flipping / deflection of the pressure focusing group unit 1400 is achieved by configuring the geometric parameters of the rib strips and the node (such as the ratio of width to thickness); the ultimate goal of this configuration is that the critical force required for the node to undergo unstable flipping and the resistance required to overcome the opening deformation in the thickness direction are both much smaller than the resistance required to overcome the opening deformation in the width direction; after this configuration is completed, the node will flip / deflect following the expansion of the balloon, and as the balloon diameter increases, the rib strips are further pulled apart to adapt to a larger diameter balloon; substituting the parameters into the well-known moment of inertia calculation formula for deduction and calculation can further verify the rationality of this structural design. It can be understood that: the deflected shape of the pressure focusing group unit 1400 is the result of one side of the node 1230 rising relative to the other side and then, along with the rib strip end (section) fixedly connected thereto, flipping / deflecting around the pivot axis (the side of the node that has not risen, such as 12301) (as shown in Figure 5 and Figure 6 ); this pivot axis usually deviates from the central axis between the two sides (12301, 12302) of the node (i.e., the pivot axis does not coincide with the central axis) and tends to be close to one side edge (such as 12301); during the transition state / period, at least some nodes 1230 rise from the balloon surface 201 (the transition / change from contacting the balloon surface 201 to moving away from the balloon surface 201); the system structure follows the principle of tending towards the lowest energy state, and the rib strips (1224, 1225, 1126, 1227) undergo torsion / distortion of the rib strip body as the node 1230 flips / tilts (the torsion / distortion of the rib strip body is due to the constraints on both ends of the rib strip by the node) to adapt to the radial expansion of the balloon 200. As shown in Figure 5The deflection shape of the pressure focusing group unit 1400 is shown. After the section 1230 flips / turns over around the pivot side 12301, the ribs (1224, 1225, 1226, 1227) fixed to the same section 1230 tend to change to a shape with the lowest energy / potential energy (stable state, such as Figure 8 and Figure 9 As shown in the figure), a deflected gap 12103 (two opposite ribs are spaced apart from each other, such as 1224 and 1225) is formed which is different from the transitional gap 12102; in the deflected form, the rib has a torsion / twisted form (that is, the surface / blade used for focusing the score tends to face radially outward of the balloon); in the torsion / twisted form, the rib surface / blade used for focusing the score twists from the middle of the rib along the length path to the two ends of the rib to smoothly connect the side (12301 or 12302) surface of the joint; as shown in the figure, the deflected gap 12103 (two opposite ribs are spaced apart from each other, such as 1224 and 1225) of the transitional gap 12102 is formed; in the deflected form, the rib has a torsion / twisted form (that is, the surface / blade used for focusing the score tends to face radially outward of the balloon); in the torsion / twisted form, the rib surface / blade used for focusing the score twists from the middle of the rib along the length path to the two ends of the rib to smoothly connect the side (12301 or 12302) surface of the joint; Figure 9 As shown, in the deflected / flipped / rolled-over pressure focusing group unit 1400, a group of ribs (such as 1224 and 1226) away from the balloon surface 201 form a slope that gradually increases in the direction of the joint (such as Figure 9 , the height H2 from the outer side of the rib to the balloon surface 201 gradually increases to H3, and then gradually decreases). Figure 3 As shown, the width of node 1230 (the black rectangular box area in the figure) of the pressure focusing group unit 1400 (the geometric dimension spanning from side 12301 to side 12302) is usually equal to or greater than the sum of the widths of the two ribs 1220 and the width of the seam 1210 on the same side (for example, the width of node 1230 is equal to the width of rib 1224 plus the width of seam 12301 plus the width of rib 1225).

[0092] The ingenious topological geometric structure design forces the blade 506 of the segment 1230 to rotate around an axis that does not coincide with the segment centerline 12303 (that is, it forces the pressure focusing group unit 1400 to tend toward one side of the segment 1230 and flip around the non-segment centerline 12303); in other words, the segment has a lateral tilting action that forms a deflected form of the pressure focusing group unit (the pressure focusing group unit has a local tilting action tending toward one side of the segment and around the non-segment centerline); it can improve the stability / reliability of the pressure focusing group unit flipping, fatigue resistance of multiple flipping, controllability of flipping behavior / action, controllability of flipping angle / deflection angle; and after the expansion force applied by the expansion device (such as a balloon catheter) to the scored sheath is removed, the pressure focusing group unit can recover from the deflected form to the initial state. Repeated stability, controllability, and resilience performance; and during the expansion process of the scored sheath, the stability of the chain flipping of a series of pressure focusing row units is improved.

[0093] like Figures 5 to 9 As shown, in the expanded state, the pressure focusing group unit 1400 has a deflection shape that tends to the joint side and flips around the non-joint center axis, so that the blade portion 506 forms a radially outward protrusion structure toward the balloon 200 (for example,Figure 9 Among them, the distance between the cutting edge 506 and the balloon surface 201: H3 is greater than H2); in other words, the cutting edge 506 forms a wavy profile with a middle radial height (distance from the balloon surface 201) greater than that at both ends. The convex structure is configured to: achieve that the pressure application area of the cutting edge on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or achieve the effect of the pressure focusing unit applying pressure to the hollow anatomical structure developing from a point to a line. As Figure 7 , Figure 8 and Figure 10 shown, the ribs where the cutting edges 506 of adjacent pressure focusing units are located and the ribs where the non-cutting edges are located are alternately connected to form a continuous longitudinal arrangement; the deflected notch sheath tube generates a longitudinally distributed periodic pressure gradient on the hollow anatomical structure.

[0094] As Figures 2 to 10 shown, in the pressure focusing unit 1400, the order of node flipping and rib torsion:

[0095] 1) Initial state: When the notch section 1200 is not expanded, both the rib 1220 and the node 1230 maintain their original positions. The ribs and nodes are arranged circumferentially, the slit 1210 is located between the ribs, and the inner wall surface 510 (or the outer wall surface 511) of the rib 1220 and the node 1230 maintains its original position. The surface of the cutting edge 506 between the inner wall surface 510 and the outer wall surface 511 maintains its original position (hidden in the slit 1210). The surface of the cutting edge 506 generally includes the cutting edge surface 5062 located on the rib 1220 and the cutting edge surface 5061 located on the node 1230. The inner wall surface 510 is on the side of the inner cavity wall surface of the tubular body of the notch sheath tube, and the outer wall surface 511 is on the side of the outer peripheral wall surface of the tubular body of the notch sheath tube.

[0096] 2) Expansion process: When the notch section 1200 is gradually radially expanded by the balloon 200, due to the action of the radial expansion force, the slit 1210 between the ribs 1220 gradually increases, and the constrained sides (12304 and 12305) of the node start to be stretched and squeezed; the pressure focusing unit 1400 successively experiences: the transition state 508, the flipping state 509. During the transition state 508 when the rib stores energy for the node, the (partial or all) inner wall surface 510 of the node 1230 is forced to change from being close to the balloon surface 201 to lifting away from the balloon surface 201 (that is, during the transition state 508, there is a gap between the node 1230 and the balloon 200); the gap distance between the node 1230 and the balloon 200 is usually smaller than the distance from the central axis 12303 of the node to one side (12301 or 12302).

[0097] iii) Flip of Section 1230: As the seam 1210 further increases, after experiencing the transition state 508, the free side (12301 / 12302) of section 1230 starts to flip / tilt before the rib 1220. This flip usually starts from one side 12302 of section 1230 lifting away from the balloon surface 201. During the flipping process, the cutting edge surface 5061 of section 1230 will protrude / expose outward, so as to contact the surface to be treated and produce a scoring effect.

[0098] iv) Response of Rib 1220: During the flipping process of section 1230, the rib 1220 will also deform. Since the ends of the ribs are fixedly connected to section 1230, they will move and adjust their positions as the section flips. However, the ribs 1220 themselves do not actively flip, but passively adjust their spatial configuration as section 1230 flips (for example, the rib body is forced to twist, so that the cutting edge surface 5062 located on the rib 1220 flips and exposes along with the cutting edge surface 5061 of section 1230).

[0099] v) Maintenance of the Deflection Shape: When the pressure focusing group unit reaches the critical stress and flips during the expansion process, one side (the cutting edge 506) of the pressure focusing group unit flips and lifts away from the balloon surface 201 (the lifting direction is as shown by the arrow); at this time, the hoop force generated by the pressure focusing group unit on the expansion unit changes. Since the wall thickness of the section is much smaller than the width, the hoop force decreases rapidly after flipping. Therefore, after the section flips up, it usually continues to flip to a certain angle to reach a new equilibrium; at this time, if the expansion unit continues to expand, the flipping angle of the section will gradually increase, and the distance between the sections will also increase accordingly, and the rib connecting the two sections will bend and deform until the flipping angle of the section reaches 90°. Figure 5

[0100] vi) Elimination of the Deflection Shape: As the balloon 200 is depressurized / its diameter retracts, the radial expansion force exerted by the balloon 200 on the scoring section 1200 gradually decreases to be released, and the deformed ribs 1220 gradually recover to the initial state 501, and drive section 1230 to reset. Until the radial dimension of the scoring section 1200 shrinks and recovers to be smaller than a certain diameter during the transition state 508 (recovers to be smaller than the upper limit diameter dimension of the scoring section 1200 during the transition state 508), section 1230 is completely reset.

[0101] Figure 9 For the scoring sheath 1000 / 3000 provided by the present invention, the pressure focusing group unit can tilt and deflect to form a radial convex structure (such as Figure 9); During the balloon inflation and dilation period, the pressure focusing group units sequentially experience the initial state 501, the transition state 508, and the deflection state 509. The pressure focusing group units can form a radial convex structure by means of the lateral turning and deflection of the nodes; during the balloon inflation and dilation period, the pressure focusing group units sequentially experience the initial state 501, the transition state 508, and the deflection state 509. In the deflection state 509, the nodes of the pressure focusing group units turn and deflect laterally prior to their fixedly connected rib strips; the lateral turning and deflection of one node drives the rib strips on both sides to turn; through chain conduction, it drives the lateral turning and deflection of other associated pressure focusing group units. In the transition state 508, the nodes of the pressure focusing group units lift from the balloon surface to form a gap. The gap distance between the node and the balloon is less than the distance from the central axis of the node to one side. In the initial state and the transition state, the pressure focusing group units do not undergo lateral turning and deflection. The pressure focusing group units that form the radial convex structure can return to the initial state of the pressure focusing group units during the period when the tubular body tends to change to the initial radial dimension; in the initial state, the pressure focusing group units have rib strips that extend substantially parallel to the axis of the tubular body. Defining the reset of the pressure focusing group units to the initial position after lateral turning and deflection as one expansion use cycle; the number of failure expansion use cycles of the notched sheath is greater than 10. After the tubular body returns to a diameter size less than the upper limit diameter dimension at the time of the transition state period, the nodes are completely reset. The notched sheath 1000 / 3000 provided by the present invention further includes an introduction structure (which can be one of 1300, 2300, 3300) near the proximal end of the tubular body.

[0102] As Figures 44 to 46 shown, further, the structural configuration of the pressure focusing group units 1800 for controlling / restraining / defining the deflection direction (for example, a number of pressure focusing group units 1800 deflect in a predetermined (expected) counterclockwise direction in the circumferential direction of the balloon): Usually, the flipping direction (counterclockwise / clockwise) of the pressure focusing group units 1400 of the notched sheath 1000 is random (because the nodes are completely symmetrical. Assuming that the notched segment nodes are designed as an asymmetrical structure, at this time the nodes are unevenly stressed, and then they will fixedly flip to one side), uncontrollable (there is a flip different from the expected one); by configuring the symmetry on both sides of the node 1230, increasing the material on one side of the node to make it larger (the geometric dimension increases, for example Figure 46 in, the free side 12332 of the node 1233), and reducing the material on the other side to make it smaller (the geometric dimension decreases, for example Figure 46 in, the free side 12331 of the node 1233), making the two sides of the node 1230 have unbalanced characteristics, so as to achieve the deflection of the node 1230 to one side according to the expectation (controllable / fixed) during the expansion process of the notched segment 1200 (if the expectation is a counterclockwise flip, then the actual flip of the pressure focusing group unit 1400 should also be counterclockwise; for example Figure 45In it, the pressure focusing group unit 1800 always performs the periodic reciprocating motion of turning - over and resetting according to the unique turning - over direction 1850 and resetting direction 1860), forming a pressure focusing group unit 1800 such as. The pressure focusing group unit 1800 can turn over in the expected direction (as Figure 45 shown), and reset in the direction reverse to the turning - over direction (as Figure 44 shown); alternatively, the pressure focusing group unit can be controlled to turn over and reset. For example Figure 46 shown, the pressure focusing group unit 1800 is configured such that: the center of gravity of section 1233 biases towards one side of the free side of the section (12332 / 12331) (for example Figures 44 to 46 the free side 12332 of the section in, tends to have a larger geometric size relative to the other free side 12331 of the geometric central axis 12303); or, the torques on the two free sides (12332 and 12331) of the section are different; or, the two sides of the section are asymmetrically configured. The purpose of the configuration is to change / suppress the randomness of the turning - over direction (counter - clockwise / clockwise turning on the cross - section of the pipe body axis) of the pressure focusing group unit 1400, forcing / restraining / controlling / limiting it to perform the turning - over action in the scheduled direction. The two constrained sides of the section are the section fixed side 12333 and the section fixed side 12334.

[0103] The pressure focusing unit 1800 includes at least one of the following features:

[0104] (a) The pressure focusing unit 1800 includes a raised structure 610 deployed on one side surface 5062 of the rib (the side surface 5062 is located in the seam 1210, between the inner wall surface 510 and the outer wall surface 511 of the tubular body);

[0105] (b) In the initial state 501, the raised structure 610 is received 1801 in the hollow seam 1210; in the expanded state 509, the raised structure 610 is exposed 1802 from the hollow seam;

[0106] (c) When the pressure focusing group unit 1800 turns over, one of its ribs (for example, rib 1228) forms a wavy profile with a greater radial height in the middle than at both ends.

[0107] In the pressure focusing group unit 1800, two ribs fixed to the same side of the section 1233 (for example Figure 46 in, rib segment 12281 and rib 12291 segment are two ribs on the same side; rib segment 12282 and rib 12292 segment are two ribs on the same side), the section close to the section has mutually different geometric sizes (the geometric size of rib segment 12291 is greater than the geometric size of rib segment 12281 on the other side of the central axis 12303).

[0108] The pressure focusing group unit 1800 is configured such that the torques on the two free sides (the free side 1810 of the pressure focusing group unit and the free side 1820 of the pressure focusing group unit) are different to achieve a controlled one-way rollover action. The constrained sides (1830 and 1840) of the pressure focusing group unit 1800 are affected by the constraints of other pressure focusing group units.

[0109] The tubular body generally further includes an introduction structure for introducing a balloon into the lumen (which can be one of 1300 / 2300 / 3300).

[0110] As Figure 30 and Figure 47 shown, the introduction structure of the tubular body includes a manifold unit and a transition seam; the manifold unit has a form in which two or more ribs are converged into one rib; the introduction structure includes at least two levels or more of manifold units (for example, the introduction structure 3300 includes the manifold unit group level 3311, the manifold unit group level 3312, the manifold unit group level 3313, a three-level manifold unit); the manifold units of the same level are arranged circumferentially along the tubular body. The purpose of setting the introduction structure is as follows: for the same patient, a single notched sheath can be flexibly replaced with various sizes of balloons during the operation, reducing the burden on the patient; for the doctor, the replacement operation is convenient and efficient; for the notched sheath, with a reasonable design of the introduction structure, it can avoid damaging the key structure of the notched sheath during the introduction of the balloon and reduce the interference with the subsequent rollover action of the pressure focusing group unit.

[0111] As Figure 47 shown, the manifold unit 3320 includes a converging portion 3321 for converging ribs 3322 (for example, the ribs 33222 and 33223 on both sides of the transition seam 3330 are converged into the rib 33221), and at least some of the converging portions are configured such that the torques on the two free sides (the free side 33211 and the free side 33212) are different to achieve a controlled one-way rollover action. The purpose of configuring the converging portion is to ensure that the pressure focusing group unit performs a directional rollover action (cooperating with the pressure focusing group unit to be able to perform the scheduled directional rollover action as scheduled after replacing the balloon or performing multiple rollover actions). For two ribs on the same side (for example, the rib 33222 and the rib 33223), a section thereof close to the converging portion (for example, the rib section 332221 and the rib section 332231) has different geometric dimensions (the geometric dimension of the rib section 332231 is greater than the geometric dimension of the rib section 332221 on the other side of the central axis 12303).

[0112] As Figure 47 shown, the manifold units of the introduction structure are arranged away from the pressure focusing group unit along the axis of the tubular body, and the number of manifold units is arranged and deployed in a decreasing manner step by step.

[0113] As Figure 48As shown, the introduction structure further includes a stability enhancement unit 3400 for assisting the controlled rollover of the pressure focusing group unit. The purpose of configuring the stability enhancement unit is to increase the stability of the two ribs between the bifurcated units (such as bifurcated unit 33201 and bifurcated unit 33202), and filter out the interference torque generated by the balloon / balloon introduction tube 700 in the introduction structure on the pressure focusing group unit. For example, the convex structure 610 of the pressure focusing group unit 1800 is initially configured to face the side of the bifurcated unit 33201 from the bifurcated unit 33203 (such as Figure 44 and Figure 46 in the orientation of the convex structure 610). If a connecting member 3410 is deployed between the bifurcated unit 33201 and the bifurcated unit 33202, the rib 3322 of the bifurcated unit 33201 will be inhibited from flipping, thereby inhibiting the occurrence of the convex structure 610 flipping towards the balloon surface.

[0114] The stability enhancement unit 3400 is a connecting member 3410 that spans the transition seam 3330 between two bifurcated units.

[0115] The stability enhancement unit 3400 is deployed and fixedly connected between the bifurcated units of the same level.

[0116] As Figure 49 shown, the present invention also provides an introduction structure 2300 different from 1300 and 3300. The introduction structure 2300 includes a guiding rib 2430 that extends / develops substantially parallel to the axis 2310, and bifurcated units 2320 symmetrically deployed on both sides in the length direction of the guiding rib 2430. The diverging ribs 23203 of the bifurcated units 2320 converge at the converging portion 23201 and then extend out the main rib 23202; the main rib 23202 is spaced from the transition seam 2330 along the length direction of the guiding rib 2430 and is fixedly connected to the guiding rib 2430 in sequence. Further, the introduction structure 2300 is often deployed as having only one level of bifurcated unit group level. Further, the bifurcated units 2320 on the guiding rib 2430 of the introduction structure 2300 are substantially flush between the converging portions 23201.

[0117] Regarding the two-sided folding rollover (as Figures 14 to 19 shown): During the expansion process, in addition to the thrust generated by the inflation of the balloon 200, the ribs 1221 / 1222 also receive the acting forces of the nodes on both sides. Since the wall thickness dimensions of the ribs 1221 / 1222 are extremely small, the ribs 1221 / 1222 only need a small acting force to become unstable and thus flip (as Figure 5 shown); such a flip is usually that the ribs on both sides of the node (including the node) roll over in the same direction, rather than the two-sided ribs folding and flipping. Through further special design of the node (such as Figure 14As shown, the geometric dimension of section 1231 is larger than that of section 1232 (e.g., 1.5 times): adjacent nodes on the same rib are on both sides of the rib respectively, and there are significant differences in the length and slit width of the two nodes; the node with greater stiffness (e.g., compared with section 1232, section 1231 has greater stiffness) is not easily stretched and unfolded circumferentially, and the ribs on both sides of it tend to fold and turn downward. The ribs on both sides of the node with smaller stiffness have more room for movement. At the same time, due to the different positions from the node with greater stiffness, the ribs of the node with smaller stiffness tend to turn upward and protrude outward. When the balloon is expanded until the outer surface of the balloon just contacts the inner surface of the scoring sheath, a uniformly distributed and vertically outward acting expansion force is applied radially to the scoring sheath. When the balloon is expanded again, the whole sheath will be continuously affected by the tensile force, and the greater the degree of expansion (diameter), the greater the tensile force. If the sheath is a hollow tube (without material removal) at this time, the forces received in all regions are the same, that is, the force received in a single region is equal. In other words, theoretically, the force magnitude in unit region n is F1, and the force magnitude of each small unit is F1 / n. After removing some materials at this time, there are (n - n1) units in the unit region, and the force magnitude is still F1, then the force magnitude of each small unit is F1 / (n - n1), that is, the more materials are removed from a position, the greater the tensile force received. When the tensile force is greater than a certain value, this region will become unstable and buckle; as Figure 2 shown, if each node is the same and flips in a single direction; as Figure 14 shown, if the nodes are different and the remaining materials in the region of section 1231 are significantly more than those in the region of section 1232, then the units in the region of section 1232 are subject to greater tensile force and are more likely to become unstable and produce large deformations; when the balloon is expanded to a certain extent, the region of section 1232 is more likely to deform, and the materials on both sides will turn upward, while the materials on both sides of the region of section 1231 will turn downward. It is found that the longer the length of the nodes of the scoring tube, the better the stability of the nodes during the expansion process and the less likely to achieve flipping. Therefore, by reducing the node length of the scoring sheath, the node stability can be reduced to a certain extent, thereby increasing the probability of inducing node folding.

[0118] The scoring sheath 2000 provided by the present invention (as Figures 14 to 19 ) has a structural configuration with the characteristic that the two sides are folded and turned over to form a pressure focusing group unit 1600 (pressure support unit 1700): the scoring section 1200 is configured to include at least two different types of sections (e.g., section 1231 and section 1232, usually with differences in geometric dimension parameters; the geometric dimension parameters include the length / width / thickness of the section), the ribs are slender (usually slenderer than the ribs of the pressure focusing group unit 1400), and the number of ribs is small (usually fewer than the number of ribs of the pressure focusing group unit 1400).

[0119] In the pressure focusing group unit 1600 (pressure support unit 1700), the order of node flipping and rib torsion:

[0120] (I) Initial state: When the notched section 1200 is not expanded, the ribs (1221 and 1222) and nodes (1231 and 1232) of the pressure focusing unit 1600 (pressure support unit 1700) maintain their original positions. The ribs are arranged circumferentially, and the node 1232 is located in the slot 1210 between the ribs.

[0121] (II) Expansion process: When the notched section 1200 starts to expand, due to the action of the radial expansion force, the slot 1210 of the pressure focusing unit 1600 (pressure support unit 1700) gradually increases, and the nodes (1231 and 1232) begin to be stretched and squeezed.

[0122] (III) Rib flipping: As the slot 1210 further increases, the ribs of the pressure focusing unit 1600 (pressure support unit 1700) are spread obliquely on a larger arc surface (relative to the same state of 1400). At the same time, the slender rib design makes the rib stability extremely low, and the ribs first become unstable and flip during expansion. During this process, the nodes are driven by the ribs to flip. This flipping usually starts from the middle of the ribs and gradually extends to both ends. During the flipping process, the edges or corners of the ribs will protrude outward, so as to contact the surface to be treated and produce a notching effect.

[0123] (IV) Response of nodes (1231 and 1232): During the rib flipping process, the nodes (1231 and 1232) of the pressure focusing unit 1600 (pressure support unit 1700) will also deform. Since the nodes (1231 and 1232) are located between the ribs, they will move and adjust their positions as the ribs flip. However, the nodes (1231 and 1232) themselves do not actively flip, but passively adjust their spatial configurations as the ribs flip.

[0124] (V) Ribs flip first: During the flipping process of the pressure focusing unit 1600 (pressure support unit 1700), it is the ribs that flip first, not the nodes. The flipping of the ribs is due to the direct action of the radial expansion force on the ribs themselves, causing the ribs to rotate along their longitudinal axes.

[0125] (VI) Nodes (1231 and 1232) adjust subsequently: As the ribs flip, the nodes (1231 and 1232) of the pressure focusing unit 1600 (pressure support unit 1700) passively adjust their positions to adapt to the new spatial configuration. The nodes (1231 and 1232) themselves do not have the ability to actively flip, but as the connection points between the ribs, they play a role in supporting and transmitting forces when the ribs flip.

[0126] Regarding the rapid exchange structural design of the notched sheath tube (such as Figures 22 to 35As shown in the figure): It is used for the rapid introduction of the lumen of the notched sheath for a balloon catheter or for the convenient exchange of the balloon catheter in the lumen of the notched sheath. The rapid exchange structure is the key structure for the notched sheath to achieve the function of safely and efficiently introducing the dilation force application device. The problem solved by the rapid exchange structure is: how to safely and efficiently introduce a balloon catheter 200 or other devices with a diameter much larger than the initial size of the notched tube into the notched tube and expand it. For adaptability, the initial size of the notched sheath is small, but the diameter of the balloon catheter to be introduced into its lumen is large, and this magnification factor often reaches more than 2 times; due to the excessive magnification factor, the situation where the balloon introduction tube 700 / balloon 200 is difficult to penetrate into the lumen of the notched sheath occurs; therefore, an introduction structure with a large expansion ratio needs to be designed to facilitate the introduction of the balloon. Usually, an open-loop setting (circumferentially non-closed, such as in the prior art, as shown in) can bring a good expansion ratio to the introduction structure; however, in the process of pushing and retrieving this open-loop introduction structure, the overall force on the open-loop structure is divergent. When the relatively thick balloon introduction tube 700 / balloon 200 is embedded inside it, due to uneven force, the proximal part will bend downward, resulting in the balloon introduction tube 700 / balloon 200 being difficult to enter the lumen of the thinner tube; during retrieval, it is also easy to get stuck on the sheath, which is not conducive to the realization of the function of the notched sheath. The present invention provides a solution / strategy: progressive introduction; that is, longitudinally, two or more types of ribs are arranged in sequence, and different types of ribs (such as in, different types of ribs 1301, 1302, 1303, 1306) have different deformation constraint forces or expansion properties, so that the device (such as the balloon introduction tube 700 / balloon 200) can be progressively introduced into the lumen of the notched sheath. The progressive introduction structure (such as in, such as different structural forms of progressive introduction structures 401-407) includes a first type of rib 1301 and a second type of rib 1302 with different expansion properties; the first type of rib 1301 and the second type of rib 1302 are arranged longitudinally; the ribs of the same type are arranged circumferentially. Further, the expansion property of the second type of rib 1302 is greater than that of the first type of rib 1301; the gap between the second type of ribs is greater than the gap between the first type of ribs; the geometric size of the second type of rib is greater than, equal to, or less than the geometric size of the first type of rib. Assume that the introduction structure is formed by etching a hollow tube wall; in the natural state planar development diagram of the introduction structure (as shown in), the total area of the gap and the ribs is S = length × width = L Figure 20 As shown, the gap 310 runs through the open-loop thrombus removal stent 300 at both ends) can bring a good expansion ratio to the introduction structure; however, in the process of pushing and retrieving this open-loop introduction structure, the overall force on the open-loop structure is divergent. When the relatively thick balloon introduction tube 700 / balloon 200 is embedded inside it, due to uneven force, the proximal part will bend downward, resulting in the balloon introduction tube 700 / balloon 200 being difficult to enter the lumen of the thinner tube; during retrieval, it is also easy to get stuck on the sheath, which is not conducive to the realization of the function of the notched sheath. The present invention provides a solution / strategy: progressive introduction; that is, longitudinally, two or more types of ribs are arranged in sequence, and different types of ribs (such as in, different types of ribs 1301, 1302, 1303, 1306) have different deformation constraint forces or expansion properties, so that the device (such as the balloon introduction tube 700 / balloon 200) can be progressively introduced into the lumen of the notched sheath. The progressive introduction structure (such as in, such as different structural forms of progressive introduction structures 401-407) includes a first type of rib 1301 and a second type of rib 1302 with different expansion properties; the first type of rib 1301 and the second type of rib 1302 are arranged longitudinally; the ribs of the same type are arranged circumferentially. Further, the expansion property of the second type of rib 1302 is greater than that of the first type of rib 1301; the gap between the second type of ribs is greater than the gap between the first type of ribs; the geometric size of the second type of rib is greater than, equal to, or less than the geometric size of the first type of rib. Assume that the introduction structure is formed by etching a hollow tube wall; in the natural state planar development diagram of the introduction structure (as shown in), the total area of the gap and the ribs is S = length × width = L Figures 22 to 28 In, different types of ribs 1301, 1302, 1303, 1306) have different deformation constraint forces or expansion properties, so that the device (such as the balloon introduction tube 700 / balloon 200) can be progressively introduced into the lumen of the notched sheath. The progressive introduction structure (such as in, such as different structural forms of progressive introduction structures 401-407) includes a first type of rib 1301 and a second type of rib 1302 with different expansion properties; the first type of rib 1301 and the second type of rib 1302 are arranged longitudinally; the ribs of the same type are arranged circumferentially. Further, the expansion property of the second type of rib 1302 is greater than that of the first type of rib 1301; the gap between the second type of ribs is greater than the gap between the first type of ribs; the geometric size of the second type of rib is greater than, equal to, or less than the geometric size of the first type of rib. Assume that the introduction structure is formed by etching a hollow tube wall; in the natural state planar development diagram of the introduction structure (as shown in), the total area of the gap and the ribs is S = length × width = L Figures 22 to 28 In, such as different structural forms of progressive introduction structures 401-407) includes a first type of rib 1301 and a second type of rib 1302 with different expansion properties; the first type of rib 1301 and the second type of rib 1302 are arranged longitudinally; the ribs of the same type are arranged circumferentially. Further, the expansion property of the second type of rib 1302 is greater than that of the first type of rib 1301; the gap between the second type of ribs is greater than the gap between the first type of ribs; the geometric size of the second type of rib is greater than, equal to, or less than the geometric size of the first type of rib. Assume that the introduction structure is formed by etching a hollow tube wall; in the natural state planar development diagram of the introduction structure (as shown in), the total area of the gap and the ribs is S = length × width = L Figure 21 As shown), the total area of the gap and the ribs is S = length × width = L S ·W S , the total area of the ribs is Q = Q i+Q j +Q k +…+Q n , then define: duty cycle η=Q / S; duty cycle η represents the percentage of the entity in the total. It can also be defined as follows: Assuming that the introduction structure is etched from a circular tube, the circumference of the circular tube is d, and it is divided into n equal parts, d ribs + d gaps = d / n; duty cycle η=d ribs / (d ribs + d gaps). The smaller the duty cycle η, the smaller the constraint of the structure on the ribs, the greater the expansion performance of the ribs, and the easier the ribs are to expand. The duty cycle η of the second type of ribs is smaller than that of the first type of ribs, which can make the end have a larger deformation amount to facilitate better embedding of the thicker tube at the end, and limit the embedded thicker tube to facilitate its continuous and smooth introduction; while the expansion performance of the first type of ribs is relatively weak, which can ensure that the ribs used for deflecting the notch in the notched sheath are not affected by the interference of the large expansion ratio ribs in the proximal introduction structure.

[0127] The design of the notched segment structure and the rapid exchange structure makes the notched sheath of the present invention no longer limited to a balloon catheter of a single size, and can realize on-site instant exchange of balloon catheters of various sizes and specifications, and flexibly handle target blood vessel cavities of different diameters and lengths.

[0128] In some specific embodiments, the present invention provides a scored sheath tube (such as Figures 1 to 12 As shown). The notched sheath comprises a tubular body 1000 having an inner cavity and a tube wall; the inner cavity can accommodate an instrument (such as a balloon catheter 200) that applies an expansion force; the tube wall has a plurality of hollow slits 1210, and ribs 1220 and nodes 1230 formed by an array of slits 1210; the node 1230 is fixed between two ribs 1221 / 1222, and the longitudinal dimension of the node is smaller than the longitudinal dimension of the rib (as shown in FIG. Figure 3 As shown); the tubular body 1000 has an initial radial dimension in an initial state (as shown Figure 1 As shown, the tubular body 1000 is in an initial state when it is not expanded by the balloon catheter 200), and in an expanded state with an increased radial dimension relative to the initial state; between the two ends of the tubular body 1000, some nodes are connected to the ribs on both sides thereof to form a pressure focusing group unit 1400; in the expanded state (such as Figure 7 As shown, the tubular body 1000 is in an expanded state when the filled balloon catheter 200 is expanded), the pressure focusing group unit 1400 is used to reduce the pressure application surface of the ribs on the hollow anatomical structure in the longitudinal direction, or the pressure focusing group unit 1400 is used to gradually increase the pressure application surface of the ribs on the hollow anatomical structure in the longitudinal direction; the pressure focusing group unit 1400 has a radially outward deflection shape (such as rib 1221) relative to the initial state, with one side of the ribs as the pivot. Figure 6 and Figure 9 As shown inFigure 7 and Figure 8 As shown, the scored area (scored section 1200) of the tubular body 1000 is composed of an array of pressure focusing group units 1400, and the scored area is used to assist or cooperate with an instrument (such as a balloon catheter) that applies a dilating force to dilate a hollow anatomical structure; as Figure 8 and Figure 9 shown, in the expanded state, the pressure focusing group unit 1400 has a radially outward deflection relative to the initial state and forms a shape with the middle higher than both ends, which is used to generate a locally concentrated punctiform dilation stress in the longitudinal direction of the hollow anatomical structure. One of the ribs of the pressure focusing group unit can continue this punctiform dilation stress in the longitudinal direction to form a linear dilation stress (as Figure 43 shown). The structural design of the pressure focusing group unit 1400 of the scored sheath tube applies the principle of topology, and can unfold the ribs to form a cutting surface during the expansion of the balloon 200, forming pressure focusing, dilating the diseased blood vessel at low pressure, and improving the blood flow of the blood vessel; after the balloon is depressurized, the scored sheath tube uses the mechanical properties of its own structure to realize the reset of the ribs and jointly realize the re-embrace with the balloon. As Figure 36 shown, when the balloon expands, the pressure focusing group unit 1400 deflects 45° - 90° with one of its ribs as the pivot (the deflection angle 502 is 45° - 90°) to perform pressure focusing, and the cutting function is strong; after the balloon is depressurized, the rib automatically returns to its original position, which helps the re-embrace and withdrawal of the bare balloon. The cost of manufacturing this scored sheath tube is low, and there are few specifications, and it can be applicable to various types of PTA ordinary balloons (with strong adaptability); it can optimize the torsional (shearing) stress and longitudinal elongation applied to the blood vessel during the expansion of the ordinary bare balloon.

[0129] In some specific embodiments, a scored sheath tube includes a tubular body 1000 having an inner cavity and a tube wall; the inner cavity can accommodate an instrument that applies a dilating force; there are a number of hollowed-out slits on the tube wall, as well as ribs and nodes formed by an array of the slits; the nodes are fixedly connected between two ribs, and the longitudinal dimension of the nodes is smaller than the longitudinal dimension of the ribs; the tubular body has an initial state with an initial radial dimension and an expanded state with a relative increase in the initial radial dimension; between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof constitute a pressure focusing group unit; in the expanded state, the pressure focusing group unit has a radially outward deflection shape relative to the initial state with one of its ribs as the pivot; in the deflection shape, the rib on the non-pivot side (such as rib 1222), the part deformed to be close to the node is higher in the radial direction than its two ends (such as Figure 9 shown, the pressure focusing group unit 1400 has the shape of a mountain peak, or as Figure 8 shown, the pressure focusing group unit 1410 and the pressure focusing group unit 1430 form a continuous wave shape in the longitudinal direction). As Figure 3 shown, in the initial state, the pressure focusing group unit has the shape of an H; as Figure 9As shown, in the expanded state, the pressure focusing group unit has a radially outward deflection relative to the initial state and forms a shape with the middle higher than both ends, which is used to generate a locally concentrated punctate expansion stress in the longitudinal direction of the hollow anatomical structure. One of the ribs of the pressure focusing group unit can continue this punctate expansion stress in the longitudinal direction to form a linear expansion stress. The notched sheath tube of the present invention is compatible with guide wires of various specifications (0.014" - 0.035"), can be adapted to balloons with specifications of 5F and 6F, and has a length of 20 - 380 mm. During the expansion process, the sheath tube ribs slowly stand up and apply an increasingly large stress concentration force to the plaque. This form of gradually applying force without mutation causes less damage to the blood vessel wall.

[0130] In some specific embodiments, a notched sheath tube includes a tubular body 1000 having a lumen and a tube wall; the lumen can accommodate an instrument for applying an expansion force; the tube wall has a number of hollowed-out slits, as well as ribs and nodes formed by an array of slits; the nodes are fixedly connected between two ribs, and the longitudinal dimension of the nodes is smaller than the longitudinal dimension of the ribs; the tubular body has an initial state with an initial radial dimension and an expanded state with a relative increase in the initial radial dimension; between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof constitute a pressure focusing group unit 1400; in the expanded state, the pressure focusing group unit is used to reduce the pressure acting surface of the ribs on the hollow anatomical structure in the longitudinal direction; the pressure focusing group unit 1400 has a radially outward deflection shape (such as Figure 9 shown) relative to the initial state, pivoting around one side rib (such as rib 1221); in the deflection shape, the rib on the non-pivoting side (such as rib 1222) deforms such that the part close to the node is higher in the radial direction than both ends (as Figure 4 shown. During the expansion process, in addition to the thrust from the expansion of the balloon 200, the ribs 1221 / 1222 also receive the pulling force from the nodes on both sides. Due to the extremely small wall thickness dimension of the ribs 1221 / 1222, the ribs 1221 / 1222 will become unstable with only a small pulling force and thus flip; Figure 5 shows the process of the pressure focusing group unit 1400 changing from the initial state to the deflection shape; Figure 6 shows the cross-sectional shape of the pressure focusing group unit 1400 standing on the surface of the balloon 200 after flipping / deflecting. This cross-sectional shape shows that the rib 1222 has a cross-sectional part overlapping the rib 1222; this cross-sectional shape also shows that the side of the rib 1222 / rib 1221 opposite to the balloon 200 has a gap with a gradually changing distance from the balloon surface). In the initial state, the pressure focusing group unit has an H shape on the same curved surface (such as Figure 3As shown, the H shape is composed of the section 1230 and the ribs 1221 / 1222 fixedly connected to both sides thereof); in the expanded state, a partial pressure focusing group unit 1400 including the section is supported or pivoted by one of the ribs (rib 1221) and deflects radially outward; in the expanded state, some non-supporting or non-pivoting ribs (rib 1222) have a middle part higher than both ends thereof (such as Figure 8 and Figure 9 As shown, the rib 1222 does not always maintain a parallel relationship with the outer surface of the balloon 200. The rib 1222 is like a toppled wavy line, with the trough contacting the balloon surface and the peak away from the balloon surface, thus periodically extending longitudinally on the balloon surface); the pressure focusing group unit is used to generate a locally concentrated expansion stress in the longitudinal direction of the hollow anatomical structure. With a split sheath design, in the non-expanded state, the whole structure is similar to a sheath, and during delivery or retraction, the damage to the blood vessel wall is small, and the intervention process is safe and reliable. When using a drug balloon to treat a lesion, during the delivery process, if the drug falls off, under the flushing action of the blood flow, the fallen drug may damage the peripheral nerves, resulting in nerve damage; at this time, if a notched sheath is used as an auxiliary delivery device, the nerve damage caused by the blood flow flushing during the drug delivery can be avoided; it can also be used as an auxiliary device for targeted drug release of the drug balloon to improve the drug utilization rate.

[0131] Some ribs serving as pivots are connected in sequence, so that the pressure focusing group units are arranged longitudinally to form a pressure focusing row unit. As Figure 8 shown, the pressure focusing group unit 1410 and the pressure focusing group unit 1430 form a pressure focusing row unit, and the pressure focusing group unit 1420 and the pressure focusing group unit 1440 form another adjacent pressure focusing row unit. In the deflected state, the distance between the ribs of the pressure focusing row unit and the axis of the tubular main body has a periodic change in the longitudinal direction; as Figure 6 and Figure 10 shown, the rib 1222 does not always maintain a parallel relationship with the outer surface of the balloon 200. The rib 1222 is like a toppled wavy line, with the trough contacting the balloon surface and the peak away from the balloon surface, thus periodically extending longitudinally on the balloon surface); if according to Figure 10In the left - hand mode, the distance 1411 between the trough where the rib 1222 contacts the balloon surface and the balloon axis 1413, and the distance 1412 between the peak of the rib 1222 away from the balloon surface and the balloon axis 1413, in the coordinate system with the balloon axial length X - the distance Y from the balloon axis 1413 to the side of the rib 1222 facing the balloon, the distance between the rib of the pressure - focusing row unit and the axis of the tubular main body has a periodic change 1414 in the longitudinal direction. The rib with the periodic change 1414 can continue this punctiform expansion stress in the longitudinal direction to form a linear expansion stress, and apply a gradually increasing stress - concentration force to the plaque. This form of applying force without sudden change and gradually is less damaging to the blood - vessel wall.

[0132] Some pivot ribs of the pressure - focusing row units are non - pivot ribs of other pressure - focusing row units; for example, Figure 8 As shown, the pivot ribs 1223 that make up the pressure - focusing group unit 1420 and the pressure - focusing group unit 1440 are non - pivot ribs of the pressure - focusing group unit 1410 and the pressure - focusing group unit 1430.

[0133] For example, Figure 7 As shown, some pressure - focusing row units are arranged circumferentially, forming a notch segment 1200 with a longitudinal length on the wall of the tubular main body.

[0134] The device for applying the expansion force includes one or a combination of a balloon - dilation catheter, a drug - coated balloon - dilation catheter, a braided balloon - dilation catheter, and an expandable stent; the notched sheath can assist or cooperate with the device to dilate the hollow anatomical structure.

[0135] A non - dilation area 1100 with a relatively fixed radial dimension value is deployed near the distal end of the tubular main body 1000. The non - dilation area 1100 is used to radially limit one end of the rib. The non - dilation area 1100 has a hollow cavity, and can track the guide wire through the hollow cavity into the diseased part of the hollow anatomical structure; the non - dilation area 1100 has a smooth and radiopaque distal end.

[0136] For example, Figure 13 As shown, a slender wire 1500 is fixedly connected to the proximal end of the tubular main body, for pulling back the notched sheath; or, a slender hypotube is fixedly connected to the proximal end of the tubular main body, for pulling and pushing the notched sheath.

[0137] For example, Figure 12 and Figures 22~30 As shown, a device - introduction area 1300 is deployed near the proximal end of the tubular main body 1000; the device - introduction area 1300 is used to guide the device for applying the expansion force into the inner cavity of the tubular main body 1000.

[0138] The device introduction area 1300 includes a branch unit 1320 and a transition seam 1331; the branch unit 1320 is used to guide the device (such as a balloon dilatation catheter, a drug-coated balloon dilatation catheter, and a braided balloon dilatation catheter) into the inner cavity of the tubular body, and the transition seam 1331 is used to guide and transition the expansion trend of the device introduction area to the distal end of the tubular body; the branch unit 1320 has a shape that converges two or more ribs into one rib; some transition seams extend to the distal end of the tubular body to the node of the pressure focusing group unit. The gap of the transition seam 1331 usually spans across both ends of the node, and in different types of ribs (such as Figures 22 to 28 In the embodiment, different types of ribs 1301, rib 1302, rib 1303, rib 1306) pass through and extend between each other; the shape of the transition seam 1331 is sometimes set to be a needle shape with one end large and the other end small, and sometimes is set to be a shape similar to a thumbtack.

[0139] The instrument introduction region 1300 includes a bevel 1310 that is at an oblique angle to the axis of the tubular body.

[0140] Near the proximal side of the instrument introduction region 1300, a slit (eg, transition slit 1331) having a gap at one end larger than the gap at the other end is disposed.

[0141] In some embodiments, a drug coating is disposed on the wall of the tubular body 1000 .

[0142] In some specific embodiments, the present invention provides another (such as Figures 14 to 19 As shown in FIG. 1 ): a notched sheath tube 2000 with the ribs on both sides of the section folded and turned sideways. A notched sheath tube includes at least an expandable portion (such as Figure 15 As shown, the expandable portion has a cage-type skeleton / frame), the expandable portion includes a plurality of ribs 1220, any of the ribs 1220 extends along the length of the expandable portion, and the plurality of ribs are arranged around the circumference of the expandable portion to circumferentially limit the expandable portion; the solid part of the expandable portion also includes a plurality of node units, and the plurality of node units are formed between two ribs adjacent to each other in the circumferential direction; in the expanded state, the expandable portion has a mesh structure formed by connecting the ribs, and the mesh structure includes a second seam 1211 of a different form from the seam 1210, and a part of each rib is folded and flipped / deflected with another part adjacent to it; the node unit includes nodes 1231 and 1232 of different geometric sizes. A non-expanded area 1100 with a relatively fixed radial dimension value is arranged near the distal end of the expandable portion, and the non-expanded area 1100 is used to radially limit one end of the rib 1220.

[0143] like Figure 16 and Figure 17As shown, when the expandable part expands radially, the rib parts on both sides at the node units (1231 / 1232) are folded and flipped / deflected; and / or, the folding and flipping directions are opposite to each other. In most cases, the rib folding and flipping / deflection at different node units (1231 / 1232) have opposite flipping directions; as shown in the figure, for any rib on the side away from the node in the pressure focusing unit 1600, it flips / deflects away from the axis of the expandable part along the arrow direction; while for any rib on the side away from the node in the pressure support unit 1700, it flips / deflects towards the axis of the expandable part along the arrow direction. If a balloon catheter is used to expand the expandable part, when the balloon inflates, any rib on the side away from the node in the pressure focusing unit 1600 deflects by 45° - 90° (the deflection angle 502 is 45° - 90°) for pressure focusing, with strong cutting function; after the balloon deflates, the rib automatically returns to the original position, which helps the bare balloon to embrace and retract. In most cases, the pressure focusing unit 1600 and the pressure support unit 1700 share a common rib. When the expandable part expands radially, in most cases, the nodes of the pressure support unit 1700 also show non-plastic bending as the expansion degree increases (such as Figure 19 in which the node 1231 shows an arc-shaped bend).

[0144] As Figure 14 shown, the geometric size of the node 1231 is larger than that of the node 1232, preferably 1.5 - 8 times the area parameter. The transverse width of the node 1231 is 0.5 - 3 times the transverse width of the node 1232; the longitudinal length of the node 1231 is 0.5 - 3 times the longitudinal length of the node 1232.

[0145] The number of ribs arranged along the circumferential direction of the expandable part is 2n, where n is an integer; and / or, the length of any node unit is 0.25 - 0.75 times the width of the node unit.

[0146] When not expanded, the transverse width of the slit 1210 is 0.5 - 3 times the transverse width of the second slit 1211; the longitudinal length of the slit 1210 is 0.5 - 5 times the longitudinal length of the second slit 1211.

[0147] When the expandable part expands radially, as Figure 16 and Figure 17As shown, the node and the ribs fixedly connected to both sides thereof form a pressure focusing unit 1600 that is away from the balloon surface and protrudes outward; the node and the ribs fixedly connected to both sides thereof form a pressure support unit 1700 that contacts the balloon surface and is recessed inward. The coordinated cooperation of the pressure focusing unit 1600 and the pressure support unit 1700 enables the pressure support unit 1700 to support the pressure focusing unit 1600 to protrude outward after the expandable part is deployed. When cutting the plaque of the cutting plate, as the stress gradually increases, the notch with a certain flexibility can be compressed downward, playing a buffering role to reduce the possible stress concentration, and achieving the protection and fatigue resistance effects on the notch.

[0148] The proximal end of the expandable part of the notch sheath 2000 further includes an instrument introduction area 1300; the instrument introduction area 1300 is used to guide the instrument applying the expansion force into the inner cavity of the tubular body 1000. When necessary, the notch sheath 2000 further includes other functional structures in the tubular body 1000, such as the wire 1500, etc.

[0149] In some specific embodiments, the present invention further provides an auxiliary introduction structure for conveniently exchanging the instruments in the cavity of the notch sheath (1000 / 2000); this auxiliary introduction structure can also be deployed on any cage outer skeleton so that other instruments (such as balloon catheters, balloon introduction tubes) can be quickly exchanged and enter the cavity of the cage outer skeleton. For example Figures 22 to 35As shown, a medical device includes a cage-shaped outer skeleton (such as the notched sheath 1000 / 2000) for sleeving on the device; a device inlet is provided at the proximal end of the cage-shaped outer skeleton (such as the beveled opening 1310, which can also be other non-inclined openings), and the device can enter or exit the inner cavity of the cage-shaped outer skeleton through the device inlet; a longitudinally extending progressive introduction structure (such as the progressive introduction structures 401-407) formed by curvilinear solid hollowing is provided near the device inlet; the progressive introduction structure can adapt to the change in the relative initial geometric size of the device inlet increasing radially (such as the balloon introduction tube 700 sleeved outside the balloon catheter in the storage state, whose initial diameter size is often larger than the device inlet size of the notched sheath, and the slits or ribs or bifurcated units of the progressive introduction structure can be passively expanded to adapt to the outer contour size of the balloon introduction tube 700); the progressive introduction structure includes a first type of rib 1340 and a second type of rib 1350 with different expansion properties; the first type of rib 1340 and the second type of rib 1350 are arranged longitudinally; the ribs of the same type (1301 / 1302 / 1303 / 1306) are arranged circumferentially; and / or, the progressive introduction structure includes slits (1330 / 1331 / 1332 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338) with different expansion properties. The expansion properties include: 1) Expansion ratio: the ratio of the maximum diameter of the progressive introduction structure after expansion to its initial diameter, and a high expansion ratio means that the progressive introduction structure can adapt to a larger device introduction; 2) Expansion uniformity: during the expansion process of the progressive introduction structure, each part can be uniformly expanded to avoid local over-expansion or deformation; such as Figure 35As shown, after the free ends 1371 / 1372 expand away from each other by a distance L, the expansion gap at the distal end of the slit 1330 is basically the same as the size of the proximal / middle expansion gap near the transition slit 1331 (i.e., it can expand evenly); 3) Force transfer efficiency: The progressive introduction structure makes the gradual introduction process of the balloon introducer tube 700 continuous and smooth; this structure can ensure the rigidity of the pushing structure (the pushing force is evenly diffused to the working strips), and the uniform contraction of the force during retraction; 4) Rebound performance: The progressive introduction structure can still quickly return to the original state in the case of multiple expansions and contractions, thus ensuring or not affecting the function realization of the cage outer skeleton (such as the notched section of the notched sheath). Especially when it is desired to restrain / restrict the radial expansion of one end of the rib near the proximal end of the notched section, it is very important to guide the progressive introduction structure to expand step by step in segments to adapt to the outer contour size of the balloon introducer tube 700 (or other instruments), and ensure that the proximal end of the notched section can be restricted, so as to deploy the first type of ribs and the second type of ribs (or deploy slits with different expansion performances) longitudinally. The slits with different expansion performances can be arranged circumferentially and alternately around the axis, or arranged adjacent to / at intervals longitudinally; the slits can have different gap sizes or different shapes; whether it is the arrangement between the slits, or the deployment of the gap size, or the deployment of the slit shape, the design purpose is to enable the progressive introduction structure to have different expansion performances longitudinally (such as Figures 22 to 28 In, by adjusting / designing the gap and shape of the slit, the longitudinal density deployment of the ribs, and the longitudinal deployment of the bifurcation units, different structural designs of the progressive introduction structure are formed). Compared with the open-loop thrombus extraction stent 300 with the relative slit 310 penetrating both ends, in most cases, the distal end / distal segment of these progressive introduction structures has a closed-loop structure (that is, in the circumferential direction, the connection between the ribs and the nodes forms a continuous ring structure, or the connection between the ribs and the ribs forms a continuous ring structure); as Figures 22 to 28 In, the connection between the closed-loop connection point 1304 and the closed-loop connection point 1305 forms a closed-loop connection at the distal end of the progressive introduction structure. This closed-loop structure can ensure the desired restraint of the proximal end of the notched section of the notched sheath. The progressive introduction structure makes the force transfer path more uniform during the pushing and retracting processes, so that the pushing and retracting are easier, and there will be no problems such as uneven distribution in the whole notched sheath, such as local knotting or excessive local opening while local opening is too small.

[0150] Assume that the progressive introduction structure is etched from a circular tube with a circular circumference of d. The same type of rib area is divided into n equal parts. Then, for each type of rib area, the rib d + the slit d = d / n, equation ①, and the rib length is L n; Duty cycle η = d ribs / (d ribs + d gaps) equation ②, duty cycle η represents the percentage of the entity to the total. Assuming the wall thickness of the circular tube is h, and a force F is applied in the direction of the wall thickness, the deflection of a single rib expansion is equivalent to a cantilever beam structure, and the deflection y = (F·L n 3 ) / (3·E·I) equation ③, E is the elastic modulus of the material, I is the moment of inertia in the thickness direction of the rib; I=(h·d 3 筋条 ) / 12 equation ④. Assuming that the progressive introduction structure expands from the initial form Φd1 to the form Φd2, the total force value of the same type of rib area is P, then the force value of a single rib is F=P / n equation ⑤, and the simultaneous solution of equations ①-⑤, the deformation capacity of a single rib y=(4·P·L n 3 ·n 2 ) / (h·(( d 筋条 +d 缝隙 )·n·η) 3 ); total deformation capacity Y = ny. Define the deformation caused by unit force K = Y / P = (4·L n 3 ·n 3 ) / (h·(( d 筋条 +d 缝隙 )·n·η) 3 The K value can be used to measure the expansion and deformation ability of the ring. The larger the K value, the easier it is to deform overall; the smaller the K value, the more difficult it is to deform.

[0151] Furthermore, in some specific embodiments, the expansion performance of the second type of ribs is greater than the expansion performance of the first type of ribs.

[0152] Furthermore, in some specific embodiments, Figure 31 and Figure 32 As shown, one second type rib is fixedly connected to two or more first type ribs to form a first bifurcated unit 1320. Further, in some specific embodiments, a third type rib is also included, and one third type rib is fixedly connected to two or more second type ribs to form a second bifurcated unit (1321 / 1322 / 1323).

[0153] Furthermore, in some specific embodiments, Figure 29 and Figure 30 As shown, some of the second type of ribs have a spiral shape extending around the center line of the cage-type outer frame. Different from the axial horizontal-vertical rib structure of the general hypotube, the spatial spiral shape of the ribs can evenly distribute the force value on each rib when pushing and pulling back the scored sheath, so that the pushing and pulling performance is improved.

[0154] Furthermore, in some specific embodiments,Figures 22 to 28 As shown, the number of second bifurcation units is less than that of the first bifurcation units.

[0155] Furthermore, in some specific embodiments, such as Figures 22~28 and Figures 33~34 shown, it further includes a slit 1330 that is hollowed out between two rib strips; a transition slit (1331 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338) between two second-type rib strips, the gap near its distal end is larger than the gap near its proximal end, and its distal end is communicated with the first-type rib strip slit; the slit of the first-type rib strip is less than or equal to the proximal slit of the second-type rib strip slit. The transition slit is generally designed to span two or more types of rib strips, or span both ends of a segment; the transition slit generally also has a morphology / shape with a relatively larger local slit compared to other slits; the transition slit is generally used to guide and transition the expansion trend of the progressive introduction structure (i.e., the instrument introduction area 1300) to the distal side, or to make the expansion slits at both ends of the progressive introduction structure evenly distributed (as Figure 35 shown in the expansion state of the progressive introduction structure, the expansion gap at the distal end of slit 1330 is basically the same as the expansion gap near the proximal / middle part of transition slit 1331). In some progressive introduction structures, such as Figure 25 shown, four categories of rib strips (1340 / 1350 / 1360 / 1390) are longitudinally arranged, so that the progressive introduction structure has a longer gradual guiding stroke, effectively suppressing the abrupt change of the expansion trend. In some progressive introduction structures, such as Figure 28 shown, two categories of rib strips (1350 / 1360) are longitudinally arranged; compared with other forms of progressive introduction structures, the guiding stroke of this structure is shortened to increase the convenience of exchange operations. In some progressive introduction structures, not shown in the figure, it is also possible to deploy only one rib strip that is superior to the cage outer skeleton main body in terms of expansion performance; in such structures, the slit of the progressive introduction structure is larger than the slit of the cage outer skeleton main body. In some progressive introduction structures, such as Figure 27 and Figure 34 shown, this type of progressive introduction structure usually has a slit 1332 that is not interconnected / communicated with the slit of the cage outer skeleton main body to ensure the constraint of the proximal rib strip of the cage outer skeleton main body; the expansion performance of this type of progressive introduction structure is usually not affected by the expansion performance of the cage outer skeleton main body. Slit 1332 usually has a appearance with a larger gap at one end than the other end.

[0156] Furthermore, in some specific embodiments, such as Figures 26 to 30As shown, it further includes an annular unit 1370 provided at the proximal end or proximal segment of the progressive introduction structure and having an opening; the diameter size of the annular hole of the annular unit 1370 can be adaptively increased; the annular unit includes two half-rings fixedly connected at one end, and the other ends of the half-rings are free ends 1371 / 1372; it is defined that the diameter size of the outer contour of the instrument is D; after the annular unit accommodates the instrument, the distance between the free ends 1371 / 1372 of the two half-rings is L; then the condition L≥π·D / 2 is satisfied. Based on the performance requirements of a large expansion ratio, in some stress conditions, the front end part of the progressive introduction structure will bend downward, resulting in difficulty for the instrument to enter the inner cavity of the progressive introduction structure; the annular unit 1370 of the present invention can maintain a semi-wrapping shape (that is, a shape of semi-clamping the outer contour of the instrument) during the process of introducing the instrument, that is, L≥π·D / 2. The design advantage of the annular unit 1370 is that the semi-wrapping ring structure can make the progressive introduction structure (that is, the instrument introduction area 1300) have a part of the semi-wrapping ring always tightly buckled on the instrument during the expansion process, making the introduction of the instrument smoother and avoiding the occurrence of the "pressing down head" phenomenon at the head end.

[0157] Further, in some specific embodiments, such as Figures 29 to 30 As shown, one side of the free ends 1371 / 1372 of the half-rings is fixedly connected to the rib; the annular unit 1370 is inclined with respect to the center line of the cage-like outer skeleton. The annular unit includes a first annular unit and a second annular unit 1380; the free ends of the half-rings of the first annular unit are fixedly connected to the free ends of the half-rings of the second annular unit 1380.

[0158] Further, in some specific embodiments, the instrument is one or a combination of a catheter, a balloon catheter, a drug-coated balloon catheter, and a guide wire.

[0159] Further, in some specific embodiments, the cage-like outer skeleton is one or a combination of a mesh stent, a notched sheath, and a balloon outer skeleton.

[0160] In some specific embodiments, the applicant unexpectedly found that: for the notched sheath (1000 / 2000) at different radial expansion sizes (non-plastic expansion), the notch units 500 (such as the pressure focusing group unit 1400 / pressure focusing unit 1600) used to gather the pressure acting surface have deflection angles that all fall within the range of greater than or equal to 45 degrees and less than or equal to 90 degrees, and the deflection angles within this range are beneficial to the notch effect of gathering pressure. The present invention also provides a kind of: such as Figures 36 to 39As shown, a rapid exchange notched sheath includes a tubular body having a lumen and a tube wall; the lumen is capable of accommodating a balloon catheter for applying a dilating force; the tube wall has a plurality of perforated slits 1210, as well as ribs 1220 and nodes (1230 / 1231 / 1232) formed by an array of slits; the nodes are fixedly connected between two ribs, and the longitudinal dimension of the nodes is smaller than the longitudinal dimension of the ribs; the tubular body has an initial state 501 with an initial radial dimension, and a dilated state with an increased radial dimension relative to the initial radial dimension; in the dilated state, some notching units 500 for aggregating pressure acting surfaces (such as pressure focusing group unit 1400 / pressure focusing unit 1600) have a deflected form with one side 506 away from the axis relative to the initial state 501 and a deflection angle 502 relative to the initial state 501 (one side of the deflection angle 502 is the surface of the balloon 200, and the other side is the connection line of the two side surfaces 506 / 507); the dilated state includes a first dilated state and a second dilated state, and the radial dimension value of the second dilated state is greater than the radial dimension value of the first dilated state; in the first dilated state, the deflection angle of the notching unit 500 is greater than or equal to 45 degrees and less than or equal to 90 degrees; and / or, in the second dilated state, the deflection angle of the notching unit 500 is greater than or equal to 45 degrees and less than or equal to 90 degrees. Further, in the range where the expansion ratio of the notched section 1200 of the notched sheath tube (1000 / 2000) is 1.5 to 15 or 2 to 10 or 3 to 6, the deflection angles of the first dilated state and the second dilated state are greater than or equal to 45 degrees and less than or equal to 90 degrees; when the expansion ratio of the notched section 1200 of the notched sheath tube (1000 / 2000) is 2, 4, 6, 8, and 10, the deflection angles of the first dilated state and the second dilated state are greater than or equal to 45 degrees and less than or equal to 90 degrees. The deflection angle of the notching unit remains substantially the same or within a substantially the same range at different radially expanded dimensions (non-plastic expansion), which is beneficial for the notched sheath tube (1000 / 2000) to be flexibly applicable or compatible with the treatment of various sizes of lumens; this significantly reduces the treatment cost of patients.

[0161] In some specific embodiments, the notching unit 500 of the rapid exchange notched sheath includes one or a combination of ribs and nodes.

[0162] In some specific embodiments, as Figure 40 shown, in the dilated state, some ribs of the notching unit have protrusions or tooth-like structures 600 facing away from the axis 505 and outward.

[0163] In some specific embodiments, near the proximal end of the tubular body of the rapid exchange notched sheath, there is an exchange port (i.e., bevel 1310) formed by slitting the tube wall of the tubular body. The exchange port is used for the rapid introduction of the balloon catheter into the lumen of the tubular body; and / or, the exchange port is used for the convenient exchange of the balloon catheter in the lumen of the tubular body; the plane where the exchange port is located is set at an inclined angle with respect to the axis of the tubular body.

[0164] In some specific embodiments, the tube wall segment for forming the rapid exchange notch sheath exchange opening includes a bifurcation unit 1320 extending distally and a transition slit (1331 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338); the bifurcation unit 1320 is used to guide the balloon catheter 200 into the lumen of the tubular body, and the transition slit is used to guide the deformation trend of adapting or conforming the exchange opening to the initial size of the guide balloon catheter towards the distal side of the tubular body; the bifurcation unit has a configuration in which two or more ribs converge into one rib. The bifurcation unit and the transition slit constitute a progressive introduction structure (i.e., the instrument introduction region 1300).

[0165] In some specific embodiments, a slender rod (i.e., wire 1500) for pushing or pulling the tubular body is provided at the proximal end of the tubular body of the rapid exchange notch sheath.

[0166] In some specific embodiments, the rapid exchange notch sheath includes a non-expansion region 1100 at one end of the radially limiting rib provided at the distal end of the tubular body. The non-expansion region is provided with a tapered head with a smooth end fixedly connected to the tubular body. The tapered head is a polymer and has radiopacity. The polymer is preferably polyether block amide + 35% BaSO 4。

[0167] The present invention also provides a kind of: as Figure 39 As shown, a peripheral vascular notch catheter includes a rapid exchange notch sheath and a balloon catheter. The notch unit has a longitudinal and circumferential deployment on the tubular body to form a notch segment; the longitudinal length of the notch segment 1200 is 10 - 350 mm; the balloon catheter includes a balloon body 200 supported on the distal segment of the catheter; the longitudinal length of the balloon body is less than or equal to the longitudinal length of the notch segment 1200.

[0168] The peripheral vascular notch catheter includes a group of balloon catheters with different dilation diameters; and / or, includes a group of balloon catheters with different longitudinal lengths. Usually, the balloon catheter specifications are configured as: balloon diameter is 1.5 - 15 mm, length is 10 - 320 mm; or balloon catheters with a specification of 5F or above.

[0169] The peripheral vascular notch catheter may also include a balloon catheter with a drug.

[0170] When the balloon body 200 is inflated, the notch segment 1200 is in an expanded state. For some notch units 500 of the peripheral vascular notch catheter, the height H1 from the surface 506 facing away from the outer surface of the balloon body to the outer surface of the balloon body is 0.05 - 5 mm.

[0171] The peripheral vascular notch catheter includes a tubular balloon introduction tube 700 (such as Figure 42As shown in the figure, one end of the balloon introducer tube 700 has an inclined opening; the balloon introducer tube 700 is sleeved outside the balloon catheter to assist in introducing the balloon catheter into the inner cavity of the rapid exchange notched sheath.

[0172] The peripheral vascular notched catheter is used to dilate the internal stenosis of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infra-popliteal artery, and renal artery; or to dilate the stenosis of the autologous or artificial arteriovenous dialysis fistula.

[0173] In some specific embodiments, the present invention provides a peripheral vascular notched catheter composed of a distal end, a notched section, a guide wire, a fixing seat, and a balloon introducer tube. The distal end of the peripheral vascular notched catheter is soft and has a certain taper, making it easy to penetrate and reach the stenosis site. The peripheral vascular notched catheter needs to be combined with a commercially available balloon catheter and used after being assembled in vitro. Distal end: used to track the guide wire through the blood vessel and enter the lesion site; the distal end is smooth and conical, making it easy to penetrate and reach the stenosis site, and the material itself has radiopacity. Notched section: the notched section can be expanded by balloon inflation to dilate the lesion site at low pressure and restore blood circulation. Guide wire: used to pull back the instrument. Balloon introducer tube: the balloon introducer tube is used to introduce the balloon catheter to form a combined instrument. The peripheral notched catheter can be adapted to 0.014", 0.018", 0.035" series, and can be adapted to peripheral balloon dilatation catheters with an effective balloon length of 20 - 220 mm or 10 - 320 mm and a balloon diameter of 3 - 8 mm.

[0174] Advantages of the peripheral vascular notched catheter:

[0175] 1) It can be compatible with guide wires of various specifications (0.014" - 0.035"), and can be adapted to balloons with 5F and 6F specifications and a length of 40 - 120 mm.

[0176] 2) The treatment effect is excellent. During the dilation process, the sheath barbs slowly stand up and apply an increasing stress concentration force to the plaque. Its final cutting effect is equivalent to that of the blade-type cutting balloon with excellent treatment effect on the market. In addition, this form of gradually applying force without mutation causes less damage to the blood vessel wall.

[0177] 3) The interventional process is safe and reliable. It adopts an integrated sheath design. In the non-dilated state, the whole structure is similar to a sheath, and less damage is caused to the blood vessel wall during delivery or withdrawal. When using a drug balloon to treat a lesion, during the delivery process, if the drug falls off, under the action of blood flow flushing, the fallen drug may damage the peripheral nerves and cause nerve damage. At this time, if a notched sheath is used as an auxiliary delivery instrument, it can avoid nerve damage caused by blood flow flushing during the delivery of the drug. In addition, it can also be used as an auxiliary instrument for targeted drug release to improve the utilization rate of the drug.

[0178] 4) Operational convenience: The contrast window can be used to observe / monitor blood vessel dilation and the postoperative treatment effect at any time.

[0179] 5) The original materials of the notched sheath can be stainless steel, Co-Cr alloy, or nitinol alloy, and it shows excellent performance in the market competition.

[0180] 6) This structure takes into account the safety during the delivery process and is safer than the cutting balloon during the delivery process.

[0181] The above embodiments are only illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical idea disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A notched sheath tube, comprising a tubular body having an inner cavity and a tube wall; the inner cavity being capable of accommodating an instrument for applying an expansion force; the tube wall having a plurality of hollowed-out slits, and ribs and nodes formed by an array of the slits; the tubular body having an initial state with an initial radial dimension and an expanded state with a radial dimension increased relative to the initial radial dimension; characterized in that, Between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; both the nodes and the ribs include cutting edges; the pressure focusing group unit has a deflection shape to achieve that the pressure acting area exerted by the cutting edges on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or to achieve the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure developing from a point to a line; in the expanded state, the nodes have a lateral tipping action to form the deflection shape of the pressure focusing group unit, and the cutting edges of the nodes rotate around an axis that does not coincide with the central axis of the nodes and are away from the axis of the initial state of the tubular body.

2. A notched sheath tube, comprising a tubular body having an inner cavity and a tube wall; the inner cavity being capable of accommodating an instrument for applying an expansion force; the tube wall having a plurality of hollow slits, as well as ribs and nodes formed by an array of the slits; the tubular body having an initial state with an initial radial dimension, and an expanded state with a radial dimension increased relative to the initial radial dimension; characterized in that, Between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; one side of the pressure focusing group unit includes a cutting edge; the pressure focusing group unit has a deflection shape to achieve that the pressure acting area exerted by the cutting edge on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or to achieve the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure developing from a point to a line; In the expanded state, the pressure focusing group unit has a local tipping action towards one side of the node and around an axis other than the central axis of the node to form a deflection shape that exposes the cutting edge.

3. A notched sheath tube, comprising a tubular body having an inner cavity and a tube wall; the inner cavity being capable of accommodating an instrument for applying an expansion force; the tube wall having a plurality of hollowed-out slits, as well as ribs and nodes formed by an array of the slits; the tubular body having an initial state with an initial radial dimension and an expanded state with a radial dimension increased relative to the initial radial dimension; characterized in that, Between the two ends of the tubular body, some nodes and the ribs fixedly connected to both sides thereof form a pressure focusing group unit; one side of the pressure focusing group unit includes a cutting edge; in the expanded state, the pressure focusing group unit has a deflection shape that tends towards one side of the node and flips around an axis other than the central axis of the node; the pressure focusing group unit with the deflection shape is used to achieve that the pressure acting area exerted by the cutting edge on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or is used to achieve the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure developing from a point to a line.

4. A notched sheath tube, characterized in that, Comprising: A tubular body having a lumen extending axially and a tube wall; A plurality of perforated slit arrays formed on the tube wall and distributed circumferentially and longitudinally, defining alternately connected ribs and nodes; The tubular body has a first radial dimension in the initial state and an expanded state expandable to a second radial dimension; At least one pressure focusing group unit composed of nodes and the ribs fixedly connected to both sides thereof; One side of the pressure focusing group unit includes a cutting edge; In the expanded state, the pressure focusing group unit has a deflection shape that tends towards one side of the node and flips around an axis other than the central axis of the node, such that the cutting edge forms a radially protruding structure; The protruding structure is configured to: achieve that the pressure acting area exerted by the cutting edge on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or achieve the effect of the pressure focusing group unit applying pressure to the hollow anatomical structure developing from a point to a line.

5. A scoring sheath tube, comprising: A tubular body having a lumen and a tube wall with a perforated slit array, the slit array forming alternately arranged ribs and nodes; The tubular body has a first radial dimension in the initial state and a second radial dimension in the expanded state; Characterized in that: At least one pressure focusing group unit composed of nodes and the ribs fixedly connected to both sides thereof; one side of the pressure focusing group unit includes a cutting edge; The pressure focusing unit is configured to: in the expanded state, the pressure focusing group unit has a local tipping action towards one side of the node and around an axis other than the central axis of the node to form a deflection shape that exposes the cutting edge; The deflection pattern includes at least one feature selected from the group consisting of: (a) The blade portion forms a wavy profile with a greater radial height in the middle than at both ends; (b) The ribs where the blade portions of adjacent pressure focusing units are located and the ribs where the non-blade portions are located are alternately connected to form a continuous longitudinal arrangement; (c) The notched sheath tube of the deflection pattern generates a longitudinally distributed periodic pressure gradient on the hollow anatomical structure.

6. The notched sheath tube according to any one of claims 1 to 4, characterized in that, The ribs where the blade portions of some adjacent pressure focusing units are located and the ribs where the non-blade portions are located are alternately connected, so that the pressure focusing group units are arranged longitudinally to form pressure focusing row units; in the deflection pattern, the distance between the blade portion of the pressure focusing row unit and the axis of the tubular body changes periodically in the longitudinal direction.

7. The notched sheath tube according to claim 6, characterized in that, Some pressure focusing row units are arranged circumferentially to form a notched section with a longitudinal length on the wall of the tubular body.

8. The notched sheath tube according to any one of claims 1 to 5, characterized in that, The device for applying an expansion force includes one or a combination of a balloon dilation catheter, a drug-coated balloon dilation catheter, a braided balloon dilation catheter, and an expandable stent; the notched sheath tube can assist or cooperate with the device to dilate the hollow anatomical structure; the device for applying an expansion force is non-fixedly engaged with the notched sheath tube.

9. The notched sheath tube according to any one of claims 1 to 5, characterized in that, A non-dilation area with a relatively fixed radial dimension value is deployed near the distal end of the tubular body, and the non-dilation area is used to radially limit one end of the rib.

10. The notched sheath tube according to claim 9, characterized in that, The non-dilation area has a hollow cavity, and the guide wire can be tracked through the hollow cavity into the lesion site of the hollow anatomical structure; the distal end of the non-dilation area is smooth and radiopaque.

11. The notched sheath tube according to any one of claims 1 to 5, characterized in that, A slender wire is fixedly connected to the proximal end of the tubular body for pulling back the notched sheath tube; or, a slender hypotube is fixedly connected to the proximal end of the tubular body for pulling and pushing the notched sheath tube.

12. The notched sheath tube according to any one of claims 1 to 5, characterized in that, An instrument introduction area is deployed near the proximal end of the tubular body; the instrument introduction area is used to guide the device for applying an expansion force into the inner cavity of the tubular body.

13. The notched sheath tube according to claim 12, characterized in that, The instrument introduction area includes a bifurcation unit and a transition slit; the bifurcation unit is used to guide the instrument into the inner cavity of the tubular body, and the transition slit is used to guide and transition the expansion trend of the instrument introduction area to the distal side of the tubular body; the bifurcation unit has a form of converging two or more ribs into one rib; some transition slits extend to the node of the pressure focusing group unit on the distal side of the tubular body.

14. The notched sheath tube according to claim 13, wherein, The instrument introduction area includes an oblique opening that forms an angle with the axis of the tubular body.

15. The notched sheath tube according to claim 13, wherein, Near the proximal side of the instrument introduction area, a slit with a larger gap at one end than the other end is deployed.

16. The notched sheath tube according to any one of claims 1 to 5, characterized in that, A drug coating is deployed on the wall of the tubular body.

17. The notched sheath tube according to any one of claims 1 to 5, characterized in that, The notched sheath tube is intended for the dilation of stenotic blood vessels, including stenosis in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infrapopliteal artery, and renal artery; or is intended for the adjuvant treatment of stenosis of autologous and artificial arteriovenous dialysis fistulas.

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