Rapid exchange nick sheath and peripheral blood vessel nick catheter

Abstract

The invention provides a rapid exchange nick sheath and a peripheral blood vessel nick catheter. The rapid exchange nick sheath comprises a tubular main body with an inner cavity and a tube wall; the inner cavity can accommodate a balloon catheter 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 joints are fixedly connected between the two ribs, and the longitudinal size of the joints is smaller than that of the ribs; 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; the device is characterized in that in the expansion state, some nicking units used for gathering the pressure acting surface have deflection forms with one sides far away from the axis relative to the initial state and deflection angles relative to the initial state; the expansion state comprises a first expansion state and a second expansion state, and the radial size value of the second expansion state is larger than that of the first expansion state. The rapid exchange nick sheath and the catheter formed by the rapid exchange nick sheath can be better suitable for operation of various different peripheral blood vessels.

Description

Technical Field

[0001] The present invention relates to interventional medical devices, in particular to a rapid exchange scoring sheath and a peripheral vascular scoring catheter. Background Art

[0002] Vascular disease is one of the primary factors threatening global human health, and it places a heavy burden on people's lives, health, and social development.

[0003] In order to better treat the lesions, especially those with severe calcification or fibrosis, sufficient pre-dilation of the lesions before peripheral and arteriovenous fistula treatment to obtain a larger lumen diameter for better subsequent treatment has become a major research direction in the medical industry. Treatment methods that require greater pressure or more focused pressure to fully open stenotic lesions have become a development trend. Interventional strategies including ultra-high pressure balloons, cutting balloons, scored balloons, and plaque atherectomy focus on physical fragmentation to expand the lesions. After the lesions are expanded, they are assisted by drug balloons to achieve longer-term vascular patency.

[0004] Currently, peripheral specialty balloons available on the market include cutting balloons, scoring balloons, spinous process balloons, mastoid balloons, and constrained balloons. Domestic and international R&D companies include Boston Scientific, Bard, Spectranetics, Ev3, and Medtronic. In these existing technologies, the blades / scoring wires / constraint structures must be welded or bonded to the balloon catheter. Consequently, different models, specifications, and sizes of peripheral specialty balloons are often required for different lesion sites / lumens, significantly increasing treatment costs. Furthermore, these existing technologies are complex, involving more than ten production steps, resulting in high costs for each individual peripheral specialty balloon.

[0005] Currently, these specialized balloons have the following problems:

[0006] 1) Existing designs, such as those with longitudinal blades firmly adhered to the balloon, are generally considered the most effective for cutting plaque or fibrosis. However, these structures are inflexible and often cannot reach and treat very tortuous lesions because the balloons are typically small in diameter and short in length. Furthermore, the specialized process of inlaying or bonding the blades and scoring components onto the balloon surface carries the risk of blades or scoring components falling off.

[0007] 2) The existing structure uses a spiral scoring wire wrapped around the periphery of the balloon. When expanded, this structure produces a spiral scoring groove at the lesion. However, in actual implementation, 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.

[0008] 3) If these specialized balloons are drug-loaded and used to treat lesions, the drug could potentially dislodge during delivery and be flushed by the bloodstream. This dislodged drug could potentially damage peripheral nerves, leading to nerve damage. In this case, using a scored sheath as an auxiliary delivery device can prevent nerve damage caused by bloodstream flushing during drug delivery. Furthermore, it can also serve as an auxiliary device for targeted drug delivery, improving drug utilization.

[0009] In summary, existing cutting or scoring balloons suffer from issues such as poor structural stability of the cutting or scoring components on the balloon surface, or they restrict balloon expansion, resulting in less-than-ideal scoring effects. This, in turn, leads to poor therapeutic efficacy and safety risks. When these balloons are drug-loaded, the drug may dislodge during delivery and damage peripheral nerves, leading to nerve damage.

[0010] Existing patent publications include U.S. Patent Publication No. US8992553B2 (entitled "Cutting Balloon Assembly and Method of Manufacturing Thereof"), which discloses a cutting balloon assembly comprising a delivery catheter, an expandable balloon mounted on the distal end of the catheter, and a scoring mesh disposed around the expandable balloon. In this cutting balloon assembly, the scoring mesh is affixed to the catheter / balloon at both ends, making it inflexible and incompatible with treatment of various lumen sizes. Furthermore, the scoring mesh's large surface area in contact with the lumen wall hinders pressure focusing and enhances the scoring effect.

[0011] Therefore, it is necessary to design a new lesion expansion device that is suitable for lumens of various sizes, has strong compatibility, simple process, and high-efficiency force-focusing scoring (for example, changing from line pressure focusing to point pressure focusing). Summary of the Invention

[0012] In view of the shortcomings of the prior art mentioned above, the purpose of the present invention is to provide a quick-exchange scoring sheath, which on the one hand solves the problem in the prior art that special peripheral balloon products of different models, specifications / sizes need to be replaced in scenarios with multiple luminal sizes, and on the other hand solves the problem that the traditional scoring grid cannot reduce the pressure application surface of the hollow anatomical structure in the longitudinal direction (that is, it is impossible to achieve a gradual increase in the pressure application area applied to the hollow anatomical structure in the longitudinal direction of the tubular body, or it is impossible to achieve the pressure application effect of the pressure focusing group unit on the hollow anatomical structure from point to line).

[0013] To achieve the above-mentioned purpose and other related purposes, the present invention is implemented by including the following technical solutions.

[0014] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a quick-exchange scoring sheath and a peripheral vascular scoring catheter, so that the scoring sheath and the scoring catheter can be applicable to a variety of different peripheral vascular application scenarios.

[0015] The present invention provides a rapid exchange scoring sheath, comprising a tubular body having an inner cavity and a tube wall; the inner cavity can accommodate a balloon catheter for applying an expansion force; the tube wall has a plurality of hollow slits, and ribs and nodes formed by an array of the slits; the node is fixed between two ribs, and the longitudinal dimension of the node is smaller than the longitudinal dimension of the rib; the tubular body has an initial state with an initial radial dimension, and an expansion state with an increase relative to the initial radial dimension; in the expansion state, some scoring units for gathering pressure action surfaces have a deflection shape with one side away from the axis relative to the initial state and a deflection angle relative to the initial state; the expansion state includes a first expansion state and a second expansion state, the radial dimension value of the second expansion state is greater than the radial dimension value of the first expansion state; the deflection angle of the scoring unit in the first expansion state is greater than or equal to 45 degrees and less than or equal to 90 degrees; and / or, the deflection angle of the scoring unit in the second expansion state is greater than or equal to 45 degrees and less than or equal to 90 degrees.

[0016] In some embodiments, the scoring unit includes one or a combination of ribs and nodes.

[0017] In some embodiments, in the expanded state, some of the ribs that are scoring units have protrusions or teeth facing outward away from the axis.

[0018] In some embodiments, an exchange port formed by a slit in the wall of the tubular body is provided near the proximal end of the tubular body, and the exchange port is used for quickly introducing a balloon catheter into the inner cavity of the tubular body; and / or, the exchange port is used for conveniently exchanging the balloon catheter in the inner cavity of the tubular body; the surface where the exchange port is located is set at an inclined angle to the axis of the tubular body.

[0019] In some embodiments, the tube wall segment formed with the exchange port includes a bifurcated unit and a transition seam extending toward the distal end; the bifurcated unit is used to guide the balloon catheter into the inner cavity of the tubular body, and the transition seam is used to adapt the exchange port to or follow the deformation trend of the initial size of the balloon catheter to guide it toward the distal side of the tubular body; the bifurcated unit has a shape that converges two or more ribs into one rib.

[0020] In some embodiments, a slender rod for pushing or pulling the tubular body is provided at the proximal end of the tubular body.

[0021] In some embodiments, the present invention includes a non-expanded region at one end of the radially limiting rib disposed at the distal end of the tubular body.

[0022] In some embodiments, the non-expanded region is provided with a tapered head with a smooth end fixed to the tubular body, wherein the tapered head is made of a polymer and has developability.

[0023] The present invention also provides a peripheral vascular scoring catheter, comprising any one of the above-mentioned rapid exchange scoring sheaths and a balloon catheter.

[0024] In some embodiments, the scoring unit is longitudinally and circumferentially deployed on the tubular body to form a scoring segment; the longitudinal length of the scoring segment is 10 to 350 mm; the balloon catheter includes a balloon body 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 scoring segment.

[0025] In some embodiments, a set of balloon catheters having different expanded diameters is included; and / or a set of balloon catheters having different longitudinal lengths is included.

[0026] In some embodiments, a balloon catheter with medication is included.

[0027] In some embodiments, the balloon body is inflated so that the scored segment is in an expanded state, and some scored units face away from the outer surface of the balloon body, with a height of 0.05 to 5 mm from the outer surface of the balloon body.

[0028] In some embodiments, the invention comprises a tubular balloon introduction tube, one end of which has an inclined opening; the balloon introduction tube is sheathed outside the balloon catheter to assist the balloon catheter in being introduced into the inner cavity of the rapid exchange scoring sheath.

[0029] In some embodiments, the peripheral vascular scoring catheter is used to dilate an internal stenosis of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, subpopliteal artery, or renal artery; or to dilate a stenosis of an autologous or artificial arteriovenous dialysis fistula.

[0030] The rapid exchange scoring sheath provided by the present invention can match different balloon catheters to form different expansion states, so that it can be applied to more peripheral vascular operation scenarios to achieve efficient force-focused scoring; it can be flexibly assembled with balloons of various sizes and specifications, and the pressure focusing group unit can achieve efficient force-focused scoring; it has the effect of being applicable to lumens of various sizes and specifications, strong compatibility, and efficient force-focused scoring; it can solve the problem that the traditional scoring grid cannot reduce the pressure action surface of the hollow anatomical structure in the longitudinal direction, and realize the gradual increase of the pressure action area applied to the hollow anatomical structure in the longitudinal direction of the tubular body, or realize the pressure application effect of the pressure focusing group unit on the hollow anatomical structure from point to line.

[0031] The ingenious topological geometric structure design forces the blade of the segment to rotate around an axis that does not coincide with the segment's central axis (that is, the pressure focusing group unit has a tendency to flip toward one side of the segment and around the non-segment central axis), which can improve the stability / reliability of the pressure focusing group unit flipping, fatigue resistance of multiple flipping, controllability of flipping behavior / action, and controllability of flipping angle / deflection angle; as well as the repeated stability, controllability, and resilience of the pressure focusing group unit returning from the deflected form to the initial state after the expansion force applied to the scored sheath by the expansion device (such as a balloon catheter) is removed; and improve the stability of the chain flipping of the series of pressure focusing row units during the expansion process of the scored sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 Shown is a schematic diagram of the three-dimensional structure of an embodiment of the scored sheath 1000 of the present invention.

[0033] Figure 2 It shows a schematic diagram of a partial two-dimensional planar unfolded structure of the notched segment 1200 in a natural state having the same-direction rollover rib feature according to the present invention.

[0034] Figure 3 A partial, physical picture of the scored segment 1200 of the scored sheath 1000 being sleeved on the balloon and in the initial state 501 is shown.

[0035] Figure 4 A partial physical image of the scored segment 1200 showing the scored sheath 1000 being placed over the balloon and in a transitional state 508

[0036] Figure 5 A partial, physical view of the scored segment 1200 of the scored sheath 1000 being placed on the balloon and in an inverted state 509 is shown.

[0037] Figure 6 Display as Figure 5 Schematic diagram of the shape and position of each rib in the transverse cross-section of the pressure focusing group unit 1400 when it is in a deflected state.

[0038] Figure 7 A pictorial representation of the scored sheath 1000 is shown with the pressure focusing group unit 1400 in a deflected configuration.

[0039] Figure 8 The diagram shows a deflected configuration of a pressure focusing row of units formed by a pressure focusing group of units 1400 arranged longitudinally.

[0040] Figure 9 Shown is a practical diagram of the deflected configuration of the pressure focusing group unit 1400 on the balloon.

[0041] Figure 10 Schematic diagram showing the periodic variation in the distance between the ribs of the pressure focusing row unit and the axis of the tubular body in the longitudinal direction.

[0042] Figure 11 A schematic diagram showing the distal local structure of a scored sheath.

[0043] Figure 12 Schematic diagram showing the proximal local structure of a scored sheath.

[0044] Figure 13 Display as Figure 1 Schematic diagram of the assembly of the scored sheath and balloon catheter.

[0045] Figure 14 It shows a schematic diagram of a partial two-dimensional planar unfolded structure of another notched sheath tube 2000 of the present invention.

[0046] Figure 15 A schematic diagram of the post-expansion deflected configuration of the expandable portion of the scored sheath 2000 is shown.

[0047] Figure 16 It shows a schematic diagram of a local deflection structure of a pressure focusing unit 1600 and a pressure supporting unit 1700 longitudinally distributed on the same rib.

[0048] Figure 17 A schematic diagram of the local deflection structure showing opposite flipping directions of the ribs at different node elements.

[0049] Figure 18 A schematic diagram of the local deflection structure showing the ribs on both sides of the node element partially folded and flipped / deflected.

[0050] Figure 19 Display as Figure 15 Schematic diagram of the shape and position of each rib in the transverse section in the deflected state.

[0051] Figure 20 Shown is a schematic diagram of the three-dimensional structure of an open-loop thrombectomy stent in the prior art.

[0052] Figure 21 A schematic diagram showing the relationship between the gap and rib areas when the imported structure is unfolded in its natural state.

[0053] Figure 22 It shows a planar unfolding schematic diagram of the progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0054] Figure 23 It shows a two-plane unfolding schematic diagram of the progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0055] Figure 24 It shows a three-plane unfolding schematic diagram of the progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0056] Figure 25 Shown is a four-plane unfolding schematic diagram of the progressive introduction structure for assisting rapid exchange of instruments in the present invention.

[0057] Figure 26 Shown is a five-plane unfolding schematic diagram of the progressive introduction structure for assisting rapid exchange of instruments in the present invention.

[0058] Figure 27 Shown is a six-plane unfolding schematic diagram of the progressive introduction structure for assisting rapid exchange of instruments in the present invention.

[0059] Figure 28 It shows a seven-plane unfolding schematic diagram of the progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0060] Figure 29 It shows one of the three-dimensional schematic diagrams of the seventh progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0061] Figure 30 The figure shows the second three-dimensional schematic diagram of the seventh progressive introduction structure for assisting the rapid exchange of instruments in the present invention.

[0062] Figure 31 Shown as a schematic diagram of the unit structure Figure 1 .

[0063] Figure 32 Shown as a schematic diagram of the unit structure Figure 2 .

[0064] Figure 33 Shown is a schematic diagram of the transition joint structure in the progressive import structure.

[0065] Figure 34 Schematic diagram showing the seam structure in the progressive introduction structure that is not interconnected / connected with the main seam of the cage exoskeleton.

[0066] Figure 35 Schematic diagram showing the expanded state of the structure with gradual introduction.

[0067] Figure 36 Schematic diagram showing the deflection configuration of the scoring unit 500 in a rapid exchange scoring sheath according to the present invention.

[0068] Figure 37 A schematic diagram showing the three-dimensional structure of a rapid exchange scoring sheath of the present invention.

[0069] Figure 38 Schematic diagram showing the structure of a balloon catheter adapted for use with a rapid exchange scored sheath.

[0070] Figure 39 Shown is a schematic diagram of the three-dimensional structure of a peripheral vascular scoring catheter of the present invention.

[0071] Figure 40 It shows a schematic diagram of a three-dimensional structure of a scoring segment with protrusions or teeth 600 according to the present invention.

[0072] Figure 41 It is a highly schematic diagram of the scoring unit 500 of the present invention after being turned over.

[0073] Figure 42 A schematic diagram showing the three-dimensional structure of a balloon introduction tube 700 used in conjunction with a peripheral vascular scoring catheter of the present invention is shown.

[0074] Figure 43 It shows a schematic diagram of the scoring method of the pressure focusing unit or pressure focusing group unit of the present invention, which gradually forms lines from points.

[0075] Figure 44 A partial physical diagram of the scored segment 1200 of the scored sheath 3000 of the present invention is shown in the initial state 501 .

[0076] Figure 45 A partial physical diagram of the scored segment 1200 of the scored sheath 3000 of the present invention is shown in the flipped state 509 .

[0077] Figure 46 Display as Figure 45 Schematic diagram of the partial two-dimensional plane unfolding structure of the medium pressure focusing unit with the scored segment 1200 having directional / controlled rollover.

[0078] Figure 47 It shows a schematic diagram of a partial two-dimensional planar expansion structure of an introduction structure 3300 extending away from the scoring segment 1200 toward the proximal end of the tubular body of the scoring sheath 3000 of the present invention.

[0079] Figure 48 It is a schematic diagram of a partial two-dimensional planar unfolded structure of an introduction structure 3300 having a stabilization reinforcement unit 3400.

[0080] Figure 49 Shown as the present invention also provides an introduction structure 2300 different from 1300 and 3300.

[0081] Figure 50 Shown is a schematic diagram of the section structure of the pressure focusing unit 1400. DETAILED DESCRIPTION

[0082] The following describes the implementation of the present invention through specific embodiments. People skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0083] See also Figures 1 to 50 . It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they have no substantive technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0084] The term "expansion performance" in this specification refers to the ability of a medical device (such as the scored sheath, progressive introduction structure, and ribs mentioned below) to expand smoothly under predetermined conditions and maintain its structural integrity and functionality during use. The key parameters of expansion performance include: 1) Expansion ratio: 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 larger diameter changes; 2) Expansion uniformity: refers to whether the various parts of the device can expand evenly during the expansion process to avoid local over-expansion or deformation; 3) Force transmission efficiency: 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) Resilience: refers to whether the device can quickly return to its original state after expansion, especially when multiple expansion and contraction are required.

[0085] The proximal end mentioned in this application is the end close to the operator, and the distal end is the end away from the operator; the longitudinal direction is the axial length direction of the scored sheath; and the circumferential direction is the direction around the axis of the scored sheath.

[0086] Currently, the types of peripheral specialty balloons on the market include cutting balloons, scoring balloons, spinous process balloons, mastoid balloons, and constrained balloons. The blades / scoring wires / constraint structures of these specialty balloons must be welded or bonded to the balloon catheter, forming an integral, inseparable, or non-detachable functional component. This integral, inseparable, or non-detachable functional component can only be adapted to multiple lumen treatment scenarios by replacing it with a different model, specification, or size. In other words, these integral, inseparable, or non-detachable peripheral specialty balloons do not support multiple lumen treatment scenarios. Furthermore, some specialty balloons have limited ability to navigate tortuous vessels. In order to solve the compatibility problem of multiple specifications and sizes of peripheral special balloons, the applicant has proposed a solution for flexible replacement of blades / scoring wires / constraint structures after extensive and in-depth research: the scoring sheath 1000 / 2000 is separate from the balloon catheter, and the scoring sheath 1000 / 2000 presents a cage-like shape in most scenarios; on the one hand, it solves the problem in the prior art that peripheral special balloon products of different models, specifications / sizes need to be replaced in scenarios with multiple luminal sizes; on the other hand, it solves the problem that the traditional scoring grid cannot reduce the pressure application surface on the hollow anatomical structure in the longitudinal direction (it is hoped that the pressure application on the hollow anatomical structure in the longitudinal direction is a progressive scoring that gradually extends from several points to form a line, such as Figure 43 As shown: a plurality of points 801 gradually extend to form a progressive scoring line 800, so as to achieve a gradual increase in the area of pressure applied to the hollow anatomical structure in the longitudinal direction of the tubular body, or to achieve the effect of the pressure application of the pressure focusing group unit on the hollow anatomical structure from point to line).

[0087] In order to realize the functions of the above-mentioned scored sheath, there are usually two challenges: one is the structural design of the scored segment 1200; the other is the design of the rapid exchange structure 1300.

[0088] Regarding the scoring segment structural design of the scoring sheath: by exchanging balloons 200 of different sizes (such as length / size) to inflate and expand, the lesion site can be expanded at low pressure to restore blood circulation and achieve the purpose of one sheath with multiple uses. The scoring segment 1200 structure is the key structure for the scoring sheath to achieve safe and efficient scoring or cutting functions. Through the special rib and section 1230 size design, the ribs 1220 of the scoring sheath are induced to become unstable during expansion. After instability, the ribs 1220 will be more likely to deform in the direction of least resistance, thereby forming a deflected morphology 1400 / 1600 (such as flipping in the same direction or folding in half on both sides) Figure 5 and Figure 18As shown); relative to the undeflected ribs, these ribs / segments with deflected morphologies 1400 / 1600 can further reduce the pressure acting surface on the inner wall of the hollow anatomical structure (realizing that the pressure acting area on the hollow anatomical structure gradually increases in the longitudinal direction of the tubular body, or realizing that the pressure applying effect of the pressure focusing group unit on the hollow anatomical structure develops from point to line), thereby achieving the purpose of force scoring / cutting; in particular, the deflected morphology 1400 can achieve a progressive scoring of the longitudinal pressure effect on the hollow anatomical structure by gradually extending from several points to form a line, such as Figure 43 As shown, a plurality of points 801 gradually extend to form a progressive scoring line 800, which can score more efficiently and controllably than a traditional blade / scoring wire.

[0089] like Figures 2 to 9 As shown, regarding the formation / generation of the deflection / flip / rollover configuration of the pressure focusing group unit 1400 (the structure generally includes a section 1230, ribs 1224, ribs 1225, ribs 1226, and ribs 1227 fixed to the section 1230; and a blade 506 for applying shear force / pressure to the hollow anatomical structure): Figure 2 and Figure 50 As shown, the slits 1210 of the scored segment 1200 are distributed indirectly; the two sides of the segment 1230 in the longitudinal direction (the length direction of the scored segment 1200) (segment constraint side 12304 and segment constraint side 12305) are fixed with ribs 1220; the segment center axis 12303 is defined as the axis between the two sides of the segment 1230 that are not fixed with ribs (segment free side 12301 and segment free side 12302). Figure 3As shown, before using the scored sheath 1000, the scored sheath 1000 is put on the unfilled balloon 200 through on-site assembly operation (on-site assembly); at this time, the cut 1210 of the scored sheath 1000 presents a natural gap 12101 because the ribs on both sides of the section 1230 (such as the ribs 1224, 1225, 1226, and 1227 fixed to the same section 1230) are not radially expanded by the balloon 200; at the same time, the two sides of the pressure focusing group unit 1400 (the scored segment 1200 usually has multiple pressure focusing group units arranged along the circumferential direction, such as 1410, 1420, and 1480) have a tendency to conform to the circumferential smoothness of the balloon 200 (that is, maintaining the original natural state / shape / morphology of the scored sheath 1000); this state is defined as the initial state 501 of the scored sheath 1000. In the initial state 501, the blade 506 is usually accommodated (or hidden) in the natural morphological gap 12101. When the balloon 200 is gradually inflated, as the balloon body diameter gradually increases and exceeds the diameter of the scored sheath 1000 (scoring segment 1200) in its natural state (radially expanded by the balloon 200), the scored segment 1200 pressure focusing group unit 1400 sequentially experiences: a transition state 508 of not flipping / deflecting / rolling over, and a deflected / flipping state 509 with a deflected shape / morphology after flipping / deflecting / rolling over. Figure 4 As shown, in the transition state 508 where the pressure focusing group unit 1400 is not turned over, the ribs store energy for the nodes, making them have a tendency to turn over; the fixed area of the node ( Figure 9In the figure, the area where the arrows on both sides of the slit 1210 are located has a tendency to stretch outward along the circumferential direction (the two free sides 12301 / 12302 of the segment); therefore, in the initial stage of expansion, the node remains circumferentially stationary, and the radial expansion causes the slit shape to gradually transition to a shape similar to a diamond, and the length of the notched sheath is slightly shortened; in this process, under the radial expansion imposed by the balloon 200 and the constraint of the notched segment 1200 structure, the ribs (1224, 1225, 1226, 1227) gradually move relative to the end fixed to the segment 1230 (deviating from the original natural shape gap 12101), thereby forming / producing a transitional shape gap 12102 (the shape of the transitional shape gap 12102 is usually olive-shaped); this relative displacement develops until the segment flipping trend overcomes the circumferential smooth trend of the balloon 200, causing the pressure focusing group unit 1400 to flip / deflect / roll over. In transition state 508, blade 506 is (still / as always / always) housed in (or hidden in) transitional gap 12102. The shape and size of transitional gap 12102 further develop and expand as the balloon diameter continues to expand; this means that the bending deformation of the ribs along the length direction is further aggravated (i.e., the force exerted on the ribs by the ends of the ribs fixed to the segments is further increased); stress concentration / stress surge occurs in the area where segment 1230 is fixed to ribs (1224, 1225, 1226, 1227) (the area indicated by the arrows on both sides of the slit 1210); in addition, one segment 1230 is simultaneously fixed to four ribs (ribs 1224, 1225, 1226, 1227). 5. Ribs 1226 and 1227), so there are 4 fixed areas on both sides of the node (fixed areas between the node and the rib ends); at a certain moment or over a certain period of time, the stress concentration levels / stress surges in these 4 fixed areas are (possibly) different; this series of changes (including structural shape changes and structural mechanics changes) stimulates local instability of the node (for example, one side 12302 of the node lifts away from the sac surface 201) to relieve redundant stress, causing the pressure focusing group unit structure to produce plastic deformation and accumulate strain energy. The forces at both ends of the node are transformed into rolling moments as the node 1230 becomes unstable, causing the node to flip / roll over (for example, with one side 12301 of the node as the pivot (the pivot usually does not coincide with the center axis 12303 of the node), the other side 12302 opposite to the pivot lifts away from the sac surface 201 ( Figure 5 in the direction of the arrow), forming Figure 5 and Figure 6 The deflection of the exposed blade 506 of the pressure focusing group unit 1400 drives the ribs on both sides to flip over, and a chain reaction occurs (from the initial flip of one section, after the chain reaction, the pressure focusing group units 1400 covering the length of the balloon are flipped, such as Figure 7 As shown in FIG. 1 , the entire notched section 1200 is turned over. Figure 5In the deflected / flipped state 509 of the pressure focusing group unit 1400, the blade 506 is forced to rotate around an axis that does not coincide with the center axis of the segment and away from the initial axis of the tubular body from the original stored / hidden state (in the initial state 501 and the transition state 508), and is gradually exposed. In other words, the pressure focusing group unit 1400 tends to one side of the segment and partially flips around the non-center axis of the segment to form a deflected state that exposes the blade 506. In this state, one of the pressure focusing group units (for example, 1410 ) The blade portion 506 and the non-blade portion 507 of another pressure focusing group unit (for example, 1420) are forced to gradually spatially stagger (that is, change to non-facing side by side) from their original facing side-by-side state (in the initial state 501 and the transition state 508), forming a deflected morphological gap 12103 (different from the transitional morphological gap 12102, the two boundary ribs are changed from the blade portion 506 and the non-blade portion 507 that were originally facing side by side to the inner wall surface 510 and the outer wall surface 511 that are basically facing each other), so that the structural mechanics of the system return to balance. The flipping / deflection of the pressure focusing group unit 1400 is achieved by configuring the geometric parameters of the ribs and nodes (such as the ratio of width to thickness); the ultimate goal of this configuration is to make the critical force required for the node to flip due to instability, and the resistance required to overcome in the thickness direction to open and deform, are much smaller than the resistance required to overcome in the width direction to open and deform; after completing this configuration, the node will flip / deflect as the balloon expands, and as the balloon diameter increases, the ribs are further stretched to accommodate the larger diameter balloon; substituting the parameters into the 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 deflection form of the pressure focusing group unit 1400 is the result of one side of the node 1230 being lifted relative to the other side, and the rib end (segment) fixed thereto flipping / deflecting around the pivot (the side of the node that is not lifted, such as 12301) (such as Figure 5 and Figure 6 As shown); the pivot axis is usually offset from the central axis between the two sides of the segment (12301, 12302) (that is, the pivot axis and the central axis do not coincide), and tends to be close to one edge (for example, 12301); in the transition state / period, at least some segments 1230 are lifted from the balloon surface 201 (transition / change from contacting the balloon surface 201 to being away from the balloon surface 201); the system structure follows the principle of tending to the lowest energy state, and the ribs (1224, 1225, 1126, 1227) are twisted / distorted as the segment 1230 flips / turns over (the twisting / distortion of the rib body is due to the constraints of the segments at both ends of the rib) to adapt to the radial expansion of the balloon 200. Figure 5As shown in the deflection state of the pressure focusing group unit 1400, after the section 1230 flips / turns sideways around the pivot side 12301, the ribs (1224, 1225, 1226, 1227) fixed to the same section 1230 tend to change to the state with the lowest energy / potential energy (stable state, such as Figure 8 and Figure 9 As shown in FIG, a deflected gap 12103 is formed that is different from the transitional gap 12102 (two opposing ribs are spatially offset from each other, such as 1224 and 1225); in the deflected form, the rib has a twisted / distorted shape (i.e., the surface / edge used for the force-concentrating notch tends to face radially outward from the balloon); in the twisted / distorted shape, the rib surface / edge used for the force-concentrating notch twists from the middle of the rib along the length path toward the ends of the rib to smoothly connect the side (12301 or 12302) of the joint; as shown in FIG. Figure 9 As shown, in the deflected / flipped / rolled pressure focusing group unit 1400, a group of ribs (such as 1224 and 1226) away from the balloon surface 201 form a slope gradually increasing in the nodal direction (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 the section 1230 (the black rectangular 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 the section 1230 is equal to the width of the rib 1224 plus the width of the seam 12301 plus the width of the rib 1225).

[0090] 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 the 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 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, the fatigue resistance of multiple flipping, the controllability of the flipping behavior / action, and the controllability of the flipping angle / deflection angle; and after the expansion force applied to the scored sheath by the expansion device (such as a balloon catheter) is removed, the pressure focusing group unit returns to its initial state from the deflected form with repeated stability, controllability, and resilience; and improve the stability of the chain flipping of the series of pressure focusing row units during the expansion process of the scored sheath.

[0091] 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 side of the segment and flips around the non-segmental axis, so that the blade 506 forms a radially outward convex structure toward the balloon 200 (for example, Figure 9 In the figure, the distance between the blade 506 and the balloon surface 201 is: H3 is greater than H2); in other words, the blade 506 forms a wavy profile with a radial height in the middle (from the balloon surface 201) greater than that at the ends. The raised structure is configured to achieve a gradual increase in the area of pressure applied by the blade on the hollow anatomical structure in the longitudinal direction of the tubular body, or to achieve a pressure application effect of the pressure focusing group unit on the hollow anatomical structure from a point to a line. Figure 7 、 Figure 8 and Figure 10 As shown, the ribs where the blades 506 of adjacent pressure focusing units are located are alternately connected with the ribs where the non-blade parts are located to form a continuous longitudinal arrangement; the deflected notched sheath generates a longitudinally distributed periodic pressure gradient on the hollow anatomical structure.

[0092] like Figures 2 to 10 As shown in FIG. 1 , the order of node flipping and rib twisting in the pressure focusing group unit 1400 is:

[0093] 1) Initial State: When the scoring segment 1200 is not expanded, the ribs 1220 and nodes 1230 maintain their original positions. The ribs and nodes are arranged circumferentially, and the slits 1210 are located between the ribs. The inner wall surfaces 510 (or outer wall surfaces 511) of the ribs 1220 and nodes 1230 maintain their original positions. The blade portion 506 between the inner wall surface 510 and the outer wall surface 511 maintains its original position (hidden within the slit 1210). The blade portion 506 generally includes a blade surface 5062 located on the ribs 1220 and a blade surface 5061 located on the nodes 1230. The inner wall surface 510 is located on the inner lumen side of the scoring sheath tubular body, and the outer wall surface 511 is located on the outer circumferential side of the scoring sheath tubular body.

[0094] II) Expansion Process: As the scored segment 1200 is gradually radially expanded by the balloon 200, the radial expansion force gradually increases the gap 1210 between the ribs 1220, and the constrained sides (12304 and 12305) of the segment begin to be stretched and squeezed. The pressure focusing group unit 1400 sequentially undergoes: a transition state 508 and a flipping state 509. During the transition state 508, when the ribs are storing energy for the segment, the (partial or complete) inner wall surface 510 of the segment 1230 is forced to transition from being in close contact with the balloon surface 201 to being lifted away from the balloon surface 201 (i.e., during the transition state 508, a gap exists between the segment 1230 and the balloon 200). The gap between the segment 1230 and the balloon 200 is typically less than the distance from the segment's central axis 12303 to one of its sides (12301 or 12302).

[0095] 3) Segment 1230 Flipping: As the gap 1210 further enlarges and passes through the transition state 508, the free side (12301 / 12302) of the segment 1230 begins to flip / tip over before the rib 1220. This flipping typically begins with one side 12302 of the segment 1230 lifting away from the balloon surface 201. During the flipping process, the blade surface 5061 of the segment 1230 protrudes / is exposed, thereby contacting the surface to be treated and producing a scoring effect.

[0096] 4) Rib 1220 Response: During the reversal of segment 1230, rib 1220 also deforms. Because the ends of the ribs are fixed to segment 1230, they move and adjust their position as the segment revolves. However, rib 1220 itself does not actively revolve; rather, it passively adjusts its spatial configuration as segment 1230 revolves (for example, the rib body is forced to twist, exposing the blade surface 5062 on rib 1220 along with the blade surface 5061 of segment 1230).

[0097] V) Maintenance of deflection shape: When the pressure focusing unit reaches the critical stress during expansion and flips over, one side of the pressure focusing unit (the blade 506) flips up away from the balloon surface 201 (the direction of the lift is as follows: Figure 5 (indicated by the arrows); at this point, the hoop force exerted by the pressure focusing group unit on the expansion unit changes. Because the wall thickness of the segment is much smaller than its width, the hoop force decreases rapidly after flipping. Therefore, after flipping, the segment usually continues to flip to a certain angle to reach a new equilibrium. At this time, if the expansion unit continues to expand, the segment will gradually increase its flip angle, and the spacing between the segments will also increase accordingly. The ribs connecting the two segments will bend and deform until the segment flip angle reaches 90°. VI) Elimination of the deflected shape: As the balloon 200 is depressurized and its diameter shrinks, the radial expansion force exerted by the balloon 200 on the scored segment 1200 gradually decreases until it is released. The deformed ribs 1220 gradually return to the initial state 501, driving the segment 1230 to reset. When the radial dimension of the scored segment 1200 shrinks to a diameter smaller than that during the transition state 508 (recovering to a diameter smaller than the upper limit of the scored segment 1200 during the transition state 508), the segment 1230 is fully reset.

[0098] The scoring sheath 1000 / 3000 provided by the present invention can have a pressure focusing unit that can be tilted and deflected to form a radially protruding structure (such as Figure 9); during the balloon filling and expansion period, the pressure focusing group unit sequentially undergoes the initial state 501, the transition state 508, and the deflection state 509. The pressure focusing group unit can form a radial convex structure by virtue of the rollover deflection of the segment; during the balloon filling and expansion period, the pressure focusing group unit sequentially undergoes the initial state 501, the transition state 508, and the deflection state 509. In the deflection state 509, the segment of the pressure focusing group unit rolls over and deflects before its fixed ribs; the rollover deflection of one segment drives the ribs on both sides to flip; through chain conduction, it drives other associated pressure focusing group units to roll over and deflect. In the transition state 508, the segment of the pressure focusing group unit is lifted from the balloon surface to form a gap. The gap distance between the segment and the balloon is less than the distance from the axis of the segment to one side. In the initial state and the transition state, the pressure focusing group unit does not roll over and deflect. The pressure focusing group unit forming a radial convex structure can return to the initial state of the pressure focusing group unit during the period when the tubular body tends to change in the initial radial size; in the initial state, the pressure focusing group unit has ribs extending substantially parallel to the axis of the tubular body. It is defined that the pressure focusing group unit returns to the initial position after tipping over and deflecting as an expansion use cycle; the number of failed expansion use cycles of the scored sheath is greater than 10. After the tubular body returns to a diameter smaller than the upper limit diameter scored during the transition state, the section is completely reset. The scored sheath 1000 / 3000 provided by the present invention also includes an introduction structure near the proximal end of the tubular body (which can be one of 1300, 2300, and 3300).

[0099] like Figures 44 to 46 As shown, further, the pressure focusing group unit 1800 has a structural configuration in which the deflection direction can be controlled / constrained / limited (for example, a plurality of pressure focusing group units 1800 deflect in a predetermined (expected) counterclockwise direction in the circumferential direction of the balloon): Under normal circumstances, the flipping direction (counterclockwise / clockwise) of the pressure focusing group unit 1400 of the scored sheath 1000 is random (because the nodes are completely symmetrical, assuming that the scored segment nodes are designed as asymmetric structures, the nodes are unevenly stressed and will be fixed to one side and flipped), and is uncontrollable (a flip different from the expected one occurs); by configuring the symmetry of both sides of the node 1230, adding material to one side of the node to make it larger (the geometric size increases, for example Figure 46 In the middle, the free side 12332 of the section 1233), the other side is made smaller by reducing the material (geometric size is reduced, e.g. Figure 46 In the embodiment of the present invention, the free side 12331 of the segment 1233 is provided, so that the two sides of the segment 1230 have an unbalanced characteristic, thereby achieving the expected (controllable / fixed) deflection to one side of the segment 1230 during the expansion process of the scoring segment 1200 (the expected flip is counterclockwise, and the actual flip of the pressure focusing group unit 1400 should also be counterclockwise; for example Figure 45In the embodiment, the pressure focusing group unit 1800 always performs a periodic reciprocating action of rolling-resetting in a unique rolling direction 1850 and reset direction 1860, forming a pressure focusing group unit 1800. The pressure focusing group unit 1800 can roll over in the expected direction (such as Figure 45 ), and reset in the opposite direction of rollover (as shown Figure 44 Alternatively, the pressure focusing unit can be controlled to flip and reset. Figure 46 As shown, the pressure focusing group unit 1800 is configured such that the center of gravity of the section 1233 is biased toward one side (e.g., Figures 44 to 46 The free side 12332 of the segment often has larger geometric dimensions than the free side 12331 of the other segment, which is located along the geometric center axis 12303); or, the torques on the two free sides of the segment (12332 and 12331) are different; or, the two sides of the segment are asymmetrically configured. The purpose of this configuration is to alter / suppress the randomness of the rollover direction (counterclockwise / clockwise flipping on the axial cross-section of the tube) of the pressure focusing group unit 1400, forcing / constraining / controlling / limiting it to perform the intended directional rollover. The two constrained sides of the segment are the fixed side 12333 and the fixed side 12334.

[0100] The pressure focusing unit 1800 includes at least one feature selected from the group consisting of:

[0101] (a) The pressure focusing unit 1800 includes a plurality of protruding structures 610 disposed on a side surface 5062 of the rib (the side surface 5062 is located in the slot 1210 and between the inner wall surface 510 and the outer wall surface 511 of the tubular body);

[0102] (b) In the initial state 501 , the protruding structure 610 is accommodated 1801 in the hollowed-out slot 1210 ; in the expanded state 509 , the protruding structure 610 is exposed 1802 from the hollowed-out slot;

[0103] (c) The pressure focusing group unit 1800 is flipped sideways so that one of the ribs (such as the rib 1228) forms a wavy profile with a radial height in the middle greater than that at both ends.

[0104] In the pressure focusing group unit 1800, two ribs (eg Figure 46 In the figure, rib segment 12281 and rib segment 12291 are two ribs on the same side; rib segment 12282 and rib segment 12292 are two ribs on the same side), and the section close to the node has different geometric dimensions (the geometric dimensions of rib segment 12291 are larger than the geometric dimensions of rib segment 12281 on the other side of the central axis 12303).

[0105] The pressure-focused group unit 1800 is configured such that the torques on its two free sides (pressure-focused group unit free side 1810 and pressure-focused group unit free side 1820) are different to achieve a controlled, one-way rollover motion. The constrained sides (1830 and 1840) of the pressure-focused group unit 1800 are affected by the constraints of the other pressure-focused group units.

[0106] The tubular body generally further includes an introduction structure (which may be one of 1300 / 2300 / 3300) for introducing a balloon into the inner cavity.

[0107] like Figure 30 and Figure 47 As shown, the introduction structure of the tubular body includes a branch unit and a transition seam; the branch unit has a shape that combines two or more ribs into one rib; the introduction structure includes at least two levels of branch units (for example, the introduction structure 3300 includes a branch unit group 3311, a branch unit group 3312, and a branch unit group 3313, a three-level branch unit); the branch units of the same level are arranged circumferentially along the tubular body. The purpose of setting up the introduction structure is: for the same patient, a scoring sheath can be flexibly replaced with balloons of various sizes as needed during surgery, reducing the burden on the patient; for the doctor, the replacement operation is convenient and efficient; for the scoring sheath, a reasonable introduction structure design can avoid the balloon damaging the key structure of the scoring sheath during the introduction process, and reduce interference with the later rollover action of the pressure focusing group unit.

[0108] like Figure 47 As shown, the manifold unit 3320 includes a converging portion 3321 for converging ribs 3322 (e.g., ribs 33222 and ribs 33223 on both sides of the transition seam 3330 converge to form ribs 33221). At least some of the converging portions are configured so that the torques on the two free sides (free side 33211 and free side 33212) differ, thereby achieving a controlled, unidirectional rollover. The purpose of configuring the converging portion is to ensure that the pressure focusing unit performs a directional rollover (enabling the pressure focusing unit to continue to perform the intended directional rollover after balloon replacement or multiple rollovers). The two ribs on the same side (for example, rib 33222 and rib 33223) have different geometric dimensions at a section close to the convergence portion (for example, rib segment 332221 and rib segment 332231) (the geometric dimensions of rib segment 332231 are larger than the geometric dimensions of rib segment 332221 on the other side of the central axis 12303).

[0109] like Figure 47 As shown, the manifold units of the introduction structure are arranged away from the pressure focusing group units along the axis of the tubular body, and the number of manifold units is gradually reduced.

[0110] like Figure 48As shown, the introduction structure also includes a stabilization enhancement unit 3400 for assisting the controlled rollover of the pressure focusing group unit. The purpose of configuring the stabilization enhancement unit is to increase the stability of the two ribs between the two bifurcated units (for example, bifurcated unit 33201 and bifurcated unit 33202) and filter out the interference torque generated by the balloon / balloon introduction tube 700 on the pressure focusing group unit in the introduction structure. For example, the convex structure 610 of the pressure focusing group unit 1800 is initially configured to be from the bifurcated unit 33203 to the side of the bifurcated unit 33201 (for example, Figure 44 and Figure 46 In the embodiment of the present invention, when the connector 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 over, thereby inhibiting the protrusion structure 610 from flipping over toward the balloon surface.

[0111] The stabilizing and reinforcing unit 3400 is a connecting member 3410 that spans the transition gap 3330 between the two bifurcated units.

[0112] The stability reinforcement unit 3400 is deployed and fixed between the manifold units at the same level.

[0113] like Figure 49 As shown, the present invention also provides an introduction structure 2300 that is different from 1300 and 3300. The introduction structure 2300 includes a guide rib 2430 extending / developing substantially parallel to the axis 2310, and diverging units 2320 symmetrically arranged on both sides of the length direction of the guide rib 2430. The diverging ribs 23203 of the diverging units 2320 converge at the converging portion 23201 to extend into main ribs 23202; the main ribs 23202 are sequentially fixed to the guide ribs 2430 with transition seams 2330 spaced apart along the length direction of the guide rib 2430. Furthermore, the introduction structure 2300 is often arranged to have only one level of diverging units. Furthermore, the diverging units 2320 on the guide ribs 2430 of the introduction structure 2300 are substantially flush with each other at their converging portions 23201.

[0114] About the folding and rolling of both sides (such as Figures 14 to 19 As shown in FIG2 ): During the expansion process, in addition to the thrust of the balloon 200, the ribs 1221 / 1222 are also subjected to the force of the nodes on both sides. Since the wall thickness of the ribs 1221 / 1222 is very small, the ribs 1221 / 1222 only need a small force to become unstable, thereby flipping (as shown in FIG2 ). Figure 5 Such a flip usually means that the bars on both sides of the node (including the node) flip in the same direction, rather than the bars on both sides folding in half. Figure 14As shown, the geometric dimensions of section 1231 are larger than those of section 1232, for example, 1.5 times): the adjacent nodes on the same rib are on both sides of the rib, and the lengths and slit widths of the two nodes are quite different; the nodes with greater stiffness (for example, compared with section 1232, section 1231 has greater stiffness) are not easily stretched and expanded in the circumferential direction, and the ribs on both sides of the nodes with smaller stiffness have a tendency to fold downward and flip over, while the ribs on both sides of the nodes with smaller stiffness have a larger space for movement. At the same time, due to the differentiated position with the nodes with larger stiffness, the ribs of the nodes with smaller stiffness have a tendency to flip upward and bulge outward. When the balloon is expanded to the point where the outer surface of the balloon just contacts the inner surface of the scored sheath, the scored sheath is radially subjected to a uniformly distributed vertical outward expansion force. When the balloon is expanded again, the sheath as a whole will be subjected to continuous tension, and the greater the degree of expansion (diameter), the greater the tension it is subjected to. If the sheath is a hollow tube (no material is removed) at this time, all regions are subjected to the same force, that is, the force on a single region is equal. In other words, theoretically, the force on unit area n is F1, and the force on each small unit is F1 / n. At this time, after removing some material, there are (n-n1) units in the unit area, and the force is still F1, so the force on each small unit is F1 / (n-n1). That is, the more material is removed, the greater the tensile force is. When the tensile force exceeds a certain value, the area will become unstable and buckle; Figure 2 As shown, if each node is consistent and flips in a single direction; Figure 14 As shown, if the nodes are different, and the remaining material in section 1231 is significantly greater than that in section 1232, then the units in section 1232 are subject to greater tension, are more prone to instability, and produce larger deformations. When the balloon expands to a certain extent, section 1232 is more likely to deform, and the material on both sides will flip upward, while the material on both sides of section 1231 will flip downward. Studies have found that the longer the length of the scored tube node, the better the node stability during expansion, and the less likely it is to flip. Therefore, by reducing the node length, the scored sheath can reduce the node stability to a certain extent, thereby increasing the probability of inducing the node to fold in half.

[0115] The scoring sheath 2000 provided by the present invention (such as Figures 14 to 19 ), having a structural configuration with the characteristics of the pressure focusing group unit 1600 (pressure supporting unit 1700) being folded and turned sideways on both sides: the scoring segment 1200 is configured to include at least two different nodes (for example, node 1231 and node 1232, which usually have different geometric size parameters; the geometric size parameters include the length / width / thickness of the node), the ribs are slender (usually slenderer than the ribs of the pressure focusing group unit 1400), and the number of ribs is small (usually less than the number of ribs of the pressure focusing group unit 1400).

[0116] In the pressure focusing group unit 1600 (pressure support unit 1700), the order of node flipping and rib twisting is:

[0117] 1) Initial state: When the scoring segment 1200 is not expanded, the ribs (1221 and 1222) and nodes (1231 and 1232) of the pressure focusing group unit 1600 (pressure supporting unit 1700) maintain their original positions, the ribs are arranged in the circumferential direction, and the node 1232 is located in the gap 1210 between the ribs.

[0118] II) Expansion process: When the scoring segment 1200 begins to expand, due to the radial expansion force, the gap 1210 of the pressure focusing group unit 1600 (pressure supporting unit 1700) gradually increases, and the nodes (1231 and 1232) begin to be stretched and squeezed.

[0119] 3) Rib flipping: As the gap 1210 continues to grow, the ribs of the pressure focusing group unit 1600 (pressure support unit 1700) are spread out diagonally on a circular arc surface with a larger span (relative to the same state as 1400). At the same time, the slender rib design makes the ribs extremely unstable, and they are the first to become unstable and flip during expansion. During this process, the nodes are driven to flip by the ribs. This flipping usually starts from the middle of the rib and gradually expands to both ends. During the flipping process, the edges or corners of the ribs will protrude outward, thereby contacting the surface to be treated and producing a scoring effect.

[0120] IV) Response of Nodes (1231 and 1232): During rib flipping, nodes (1231 and 1232) of pressure focusing group unit 1600 (pressure support unit 1700) also deform. Because nodes (1231 and 1232) are located between the ribs, they move and adjust their position as the ribs flip. However, nodes (1231 and 1232) themselves do not actively flip, but rather passively adjust their spatial configuration as the ribs flip.

[0121] 5) Rib flips first: During the flipping process of the pressure focusing unit 1600 (pressure support unit 1700), the ribs flip first, not the nodes. The rib flips because the radial expansion force acts directly on the ribs themselves, causing them to rotate along their longitudinal axis.

[0122] VI) Nodes (1231 and 1232) subsequently adjust: As the ribs flip, nodes (1231 and 1232) of pressure focusing unit 1600 (pressure support unit 1700) passively adjust their positions to accommodate the new spatial configuration. Nodes (1231 and 1232) themselves do not have the ability to actively flip, but rather serve as connection points between ribs, providing support and transmitting force during rib flipping.

[0123] Regarding the rapid exchange structure design of the notched sheath (such as Figures 22 to 35As shown): used for the rapid introduction of a balloon catheter into the inner lumen of a scored sheath, or for the convenient exchange of a balloon catheter in the inner lumen of a scored sheath. The rapid exchange structure is a key structure for the scored sheath to achieve the function of safely and efficiently applying expansion force to introduce an instrument. The problem that the rapid exchange structure solves is: how to safely and efficiently introduce a balloon catheter 200 or other instrument with a diameter much larger than the initial size of the scored tube into the scored tube and allow it to expand. For adaptability, the initial size of the scored sheath is small, but the diameter of the balloon catheter to be introduced into its inner lumen is large, and the magnification factor often reaches more than 2 times; due to the excessive magnification factor, it becomes difficult for the balloon introduction tube 700 / balloon 200 to penetrate the inner lumen of the scored sheath; therefore, it is necessary to design an introduction structure with a large expansion ratio to facilitate the introduction of the balloon. Usually, an open-loop setting (circumferentially non-closed, such as in the prior art, such as Figure 20 As shown, the open-loop thrombectomy stent 300 with a gap 310 running through both ends can bring a good expansion ratio to the introduction structure; however, during the pushing and retrieval process of this open-loop introduction structure, the overall force of the open-loop structure is divergent, and when the thicker balloon introduction tube 700 / balloon 200 is embedded inside it, the uneven force will cause the proximal part to bend downward, making it difficult for the balloon introduction tube 700 / balloon 200 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 functional realization of the scored sheath. The present invention provides a solution / strategy: progressive introduction; that is, in the longitudinal direction, 2 or more types of ribs are deployed in sequence, and different types of ribs (such as Figures 22 to 28 In the embodiment, different types of ribs (1301, 1302, 1303, 1306) have different deformation constraints or expansion properties, so that the device (such as the balloon introduction tube 700 / balloon 200) can be gradually introduced into the inner cavity of the scored sheath. Figures 22 to 28 In the embodiment, the progressive introduction structure 401 to 407 of different structural forms 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. Furthermore, the expansion property of the second type of rib 1302 is greater than the expansion property of the first type of rib 1301; the gaps between the second type of ribs are greater than the gaps between the first type of ribs; the geometric dimensions of the second type of ribs are greater than the geometric dimensions of the first type of ribs, or the geometric dimensions of the second type of ribs are equal to the geometric dimensions of the first type of ribs, or the geometric dimensions of the second type of ribs are smaller than the geometric dimensions of the first type of ribs. Assume that the introduction structure is formed by etching the hollow tube wall; in the natural state plane unfolding diagram of the introduction structure (such as Figure 21 As shown), the total area of the gap and ribs is S = length times 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; the expansion performance of the first type of ribs is relatively weak, which can ensure that the ribs used for deflecting the notch of the notched sheath are not affected by the interference of the large expansion ratio ribs in the proximal introduction structure.

[0124] The design of the scoring segment structure and the rapid exchange structure means that the scoring sheath of the present invention is no longer limited to a single size balloon catheter, and can realize on-site instant exchange of balloon catheters of various sizes, and flexibly handle target blood vessel cavities of different diameters and lengths.

[0125] In some specific embodiments, the present invention provides a scoring sheath with ribs and sections turned sideways in the same direction (e.g. Figures 1 to 12 As shown). The scored sheath comprises a tubular body 1000 having an inner cavity and a wall; the inner cavity is capable of accommodating an instrument for applying expansion force (such as a balloon catheter 200); the wall is provided with a plurality of hollow slits 1210, and ribs 1220 and nodes 1230 formed by the 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 ribs (such as Figure 3 The tubular body 1000 has an initial radial dimension (as shown); Figure 1 As shown, the tubular body 1000 is in its initial state before being expanded by the balloon catheter 200), and in its expanded state with an increased radial dimension relative to the initial state; between the two ends of the tubular body 1000, some nodes and ribs fixed to both sides thereof constitute the pressure focusing group unit 1400; in the expanded state (as shown Figure 7 As shown, the tubular body 1000 is in an expanded state when the balloon catheter 200 is filled and 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 the rib 1221) relative to the initial state with one side of the ribs as the pivot. Figure 6 and Figure 9 As shown). Figure 7 and Figure 8 As shown, the scored area (scored segment 1200) of the tubular body 1000 is formed by 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 an expansion force to expand a hollow anatomical structure; Figure 8 and Figure 9 As 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 in which the middle portion is higher than the two ends, so as to generate a localized point-shaped expansion stress in the longitudinal direction of the hollow anatomical structure. One of the ribs of the pressure focusing group unit can continue this point-shaped expansion stress in the longitudinal direction to form a linear expansion stress (such as Figure 43 As shown). The pressure focusing unit 1400 of the scored sheath is designed based on topological principles. During the expansion of the balloon 200, the ribs are deployed to form a cutting surface, forming a pressure focus, dilating the diseased blood vessels under low pressure and improving the blood flow of the blood vessels. After the balloon is decompressed, the scored sheath uses the mechanical properties of its structure to achieve the repositioning of the ribs and achieves retraction together with the balloon. Figure 36 As shown, during balloon inflation, the pressure focusing unit 1400 pivots 45° to 90° (deflection angle 502 is 45° to 90°) around one of the ribs on one side, focusing pressure and enhancing cutting capabilities. After balloon decompression, the ribs automatically return to their original positions, facilitating the retraction and retraction of the bare balloon. This scored sheath offers low manufacturing costs and a limited number of specifications, making it suitable for various types of conventional PTA balloons (highly adaptable). It can also optimize the torsional (shear) stress and longitudinal elongation applied to blood vessels by conventional bare balloons during expansion.

[0126] In some specific embodiments, a scored sheath includes a tubular body 1000 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 hollow slits, and ribs and nodes formed by an array of slits; the node is fixed between two ribs, and the longitudinal dimension of the node is smaller than the longitudinal dimension of the rib; the tubular body has an initial state with an initial radial dimension, and an expanded state with an increase relative to the initial radial dimension; between the two ends of the tubular body, some nodes and the ribs fixed on both sides thereof constitute a pressure focusing group unit; in the expanded state, the pressure focusing group unit has a radially outward deflected form relative to the initial state, with one side rib as the pivot; in the deflected form, the rib on the non-pivot side (such as rib 1222) is deformed so that the portion close to the node is radially higher than its two ends (such as Figure 9 As shown, the pressure focusing group unit 1400 has a peak shape, or as Figure 8 As shown, the pressure focusing group unit 1410 and the pressure focusing group unit 1430 form a continuous wave shape in the longitudinal direction. Figure 3 As shown, in the initial state, the pressure focusing group unit has the shape of H; 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 in which the middle part is higher than the two ends, which is used to generate a localized point-like expansion stress in the longitudinal direction of the hollow anatomical structure. One of the ribs of the pressure focusing group unit can continue this point-like expansion stress in the longitudinal direction to form a linear expansion stress. The notched sheath of the present invention is compatible with guidewires of various specifications (0.014"-0.035") and can be adapted to 5F and 6F specifications and balloons of 20-380mm in length. During the expansion process, the sheath ribs slowly stand up and apply a gradually increasing stress concentration force to the plaque. This form of action of gradually applying force without sudden changes causes less damage to the blood vessel wall.

[0127] In some specific embodiments, a scored sheath includes a tubular body 1000 having an inner cavity and a tube wall; the inner cavity can accommodate an instrument that applies an expansion force; the tube wall has a plurality of hollow slits, and ribs and nodes formed by an array of slits; the node is fixed between two ribs, and the longitudinal dimension of the node is smaller than the longitudinal dimension of the rib; the tubular body has an initial state with an initial radial dimension, and an expanded state with an increase relative to the initial radial dimension; between the two ends of the tubular body, some nodes and the ribs fixed on both sides thereof constitute a pressure focusing group unit 1400; in the expanded state, the pressure focusing group unit is used to reduce the longitudinal pressure application surface of the ribs on the hollow anatomical structure; the pressure focusing group unit 1400 has a radially outward deflection shape (such as rib 1221) relative to the initial state, with one side rib as the pivot. Figure 9 In the deflected configuration, the ribs on the non-pivot side (eg, ribs 1222) are deformed so that the portion near the node is radially higher than the ends thereof (eg, Figure 4 As shown, during the expansion process, in addition to the thrust from the balloon 200, the ribs 1221 / 1222 are also subjected to tension from the nodes on both sides. Since the wall thickness of the ribs 1221 / 1222 is extremely small, the ribs 1221 / 1222 only require a relatively small tension to become unstable and thus flip over. Figure 5 The process of the pressure focusing group unit 1400 changing from the initial state to the deflected state is shown; Figure 6 The cross-sectional shape of the pressure focusing group unit 1400 after flipping / deflection and standing on the surface of the balloon 200 is shown. The cross-sectional shape shows that the rib 1222 has a cross-sectional portion overlapping the rib 1222; the cross-sectional shape also shows that the side of the rib 1222 / rib 1221 opposite to the balloon 200 has a gradually changing gap 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 a section 1230 and ribs 1221 / 1222 fixed to its two sides); in the expanded state, the pressure focusing group unit 1400 containing the section deflects radially outward with one of the ribs (rib 1221) as a support or pivot; in the expanded state, some non-supporting or non-pivoting ribs (rib 1222) have a middle portion higher than their two ends (such as Figure 8 and Figure 9 As shown, the ribs 1222 and the outer surface of the balloon 200 are not always parallel. The ribs 1222 are like inverted wavy lines, with the troughs touching the balloon surface and the crests away from the balloon surface, thus periodically extending longitudinally on the balloon surface); the pressure focusing group unit is used to generate locally concentrated expansion stress in the longitudinal direction of the hollow anatomical structure. A split sheath design is adopted. In the non-expanded state, the entire structure is similar to a sheath. During delivery or withdrawal, the damage to the blood vessel wall is small, and the interventional process is safe and reliable. When using a drug balloon to treat lesions, if the drug falls off during delivery, the drug may damage the peripheral nerves under the action of blood flow flushing, causing nerve damage; 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; it can also be used as an auxiliary device for targeted release of a drug ball to increase the utilization rate of the drug.

[0128] Some pivoting ribs are connected in sequence, so that the pressure focusing group units are arranged longitudinally to form pressure focusing row units, such as Figure 8 As shown, pressure focusing group unit 1410 and pressure focusing group unit 1430 constitute a pressure focusing row unit, and pressure focusing group unit 1420 and pressure focusing group unit 1440 constitute 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 body has a periodic change in the longitudinal direction; as shown in FIG. Figure 6 and Figure 10 As shown, the ribs 1222 and the outer surface of the balloon 200 are not always parallel to each other. The ribs 1222 are like inverted wave lines, with the troughs touching the balloon surface and the crests away from the balloon surface, and thus periodically extending longitudinally on the balloon surface. Figure 10In the left-hand approach, the distance 1411 between the trough of rib 1222 contacting the balloon surface and the balloon axis 1413, as well as the distance 1412 between the peak of rib 1222 away from the balloon surface and the balloon axis 1413, are longitudinally periodically varied 1414 in the coordinate system defined by the balloon's axial length (X) minus the distance (Y) from the balloon's axis 1413 to the side of rib 1222 facing the balloon. This periodic variation 1414 in the ribs of the pressure focusing row unit and the tubular body's axis continues this point-like expansion stress into a linear expansion stress in the longitudinal direction, exerting a gradually increasing concentrated stress force on the plaque. This gradual force application without sudden changes reduces damage to the vessel wall.

[0129] The pivot bars of some pressure focusing rows are non-pivot bars of other pressure focusing rows; Figure 8 As shown, the pivot ribs 1223 constituting 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 .

[0130] like Figure 7 As shown, some pressure focusing row units are arranged circumferentially to form a scoring segment 1200 having a longitudinal length on the wall of the tubular body.

[0131] The device for applying 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.

[0132] Near the distal end of tubular body 1000, a non-expandable region 1100 with relatively fixed radial dimensions is positioned to radially limit one end of the rib. Non-expandable region 1100 has a hollow cavity, allowing a guidewire to be tracked through it to access the lesion within the hollow anatomical structure. Non-expandable region 1100 also has a smooth, radiopaque distal end.

[0133] like Figure 13 As shown, the proximal end of the tubular body is fixedly connected with a slender wire 1500 for pulling and retracting the scoring sheath; or, the proximal end of the tubular body is fixedly connected with a slender hypotube for pulling and pushing the scoring sheath.

[0134] like Figure 12 and Figures 22 to 30 As shown, an instrument introduction region 1300 is disposed near the proximal end of the tubular body 1000 ; the instrument introduction region 1300 is used to guide an instrument for applying expansion force into the inner cavity of the tubular body 1000 .

[0135] The instrument introduction area 1300 includes a bifurcated unit 1320 and a transition seam 1331; the bifurcated unit 1320 is used to guide the instrument (such as a balloon dilatation catheter, a drug-coated balloon dilatation catheter, or 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 instrument introduction area toward the distal end of the tubular body; the bifurcated unit 1320 has a shape that combines two or more ribs into one rib; some transition seams extend toward the distal end of the tubular body to the section of the pressure focusing group unit. The gap of the transition seam 1331 usually spans across both ends of the section, and in different types of ribs (such as Figures 22 to 28 In the figure, 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 a needle shape with one end large and the other end small, and sometimes it is set to a shape similar to a thumbtack.

[0136] The instrument introduction region 1300 includes a bevel 1310 that is angled obliquely to the axis of the tubular body.

[0137] Near the proximal side of the instrument introduction region 1300, a slit (eg, a transition slit 1331) is disposed with a gap at one end larger than the gap at the other end.

[0138] In some embodiments, a drug coating is disposed on the wall of tubular body 1000 .

[0139] In some specific embodiments, the present invention provides another (eg Figures 14 to 19 As shown): a notched sheath 2000 with the ribs on both sides of the section folded and turned sideways. A notched sheath comprises at least an expandable portion (such as Figure 15 As shown, the expandable portion has a cage-like skeleton / framework. The expandable portion includes a plurality of ribs 1220, each of which extends along the length of the expandable portion. The plurality of ribs are arranged circumferentially around the expandable portion to circumferentially define the expandable portion. The solid portion of the expandable portion also includes a plurality of node units, each of which is formed between two circumferentially adjacent ribs. In the expanded state, the expandable portion has a mesh structure formed by connecting the ribs. The mesh structure includes a second slit 1211 of a different configuration from the slit 1210. A portion of each rib is folded / deflected relative to its adjacent portion. The node units include nodes 1231 and 1232 of different geometric dimensions. A non-expandable region 1100 with a relatively fixed radial dimension is disposed near the distal end of the expandable portion. The non-expandable region 1100 is used to radially limit one end of the rib 1220.

[0140] like Figure 16 and Figure 17As shown, when the expandable portion radially expands, the ribs on both sides of the node units (1231 / 1232) fold in half, flip, or deflect; and / or, the folding and flipping occur in opposite directions. In most cases, the ribs at different node units (1231 / 1232) fold in half, flip, or deflect in opposite directions. As shown in the figure, any rib in the pressure-focusing unit 1600, located on the side away from the node, flips in the direction of the arrow, away from the axis of the expandable portion; while any rib in the pressure-supporting unit 1700, located on the side away from the node, flips in the direction of the arrow, toward the axis of the expandable portion. If the expandable portion is expanded using a balloon catheter, when the balloon is inflated, any rib in the pressure-focusing unit 1600, located on the side away from the node, deflects 45° to 90° (deflection angle 502 is 45° to 90°), providing pressure focusing and enhancing cutting performance. After the balloon is depressurized, the ribs automatically return to their original positions, facilitating the retraction and withdrawal of the bare balloon. In most cases, the pressure focusing unit 1600 and the pressure supporting unit 1700 have a common rib. When the expandable portion radially expands, in most cases, the nodes of the pressure supporting unit 1700 will also show non-plastic bending (such as Figure 19 In the figure, section 1231 is curved in an arc shape).

[0141] like Figure 14 As shown, the geometric dimensions of segment 1231 are larger than those of segment 1232, preferably 1.5 to 8 times the area parameter. The transverse width of segment 1231 is 0.5 to 3 times the transverse width of segment 1232; and the longitudinal length of segment 1231 is 0.5 to 3 times the longitudinal length of segment 1232.

[0142] The number of ribs arranged along the circumference of the expandable portion is 2n, where n is an integer; and / or the length of any node unit is 0.25 to 0.75 of the width of the node unit.

[0143] When not expanded, the transverse width of the slit 1210 is 0.5 to 3 times the transverse width of the second slit 1211 ; the longitudinal length of the slit 1210 is 0.5 to 5 times the longitudinal length of the second slit 1211 .

[0144] When the expandable portion is radially expanded, as Figure 16 and Figure 17As shown, the segment and the ribs fixed on both sides form a pressure-focusing unit 1600 that is away from the balloon surface and protrudes outward; the segment and the ribs fixed on both sides form a pressure-supporting unit 1700 that contacts the balloon surface and is recessed inward. The coordinated cooperation between pressure-focusing unit 1600 and pressure-supporting unit 1700 allows pressure-focusing unit 1600 to protrude outward after the expandable portion is deployed. When cutting the plaque, as stress gradually increases, the flexible notches can compress downward, acting as a buffer to reduce possible stress concentration, protect the notches, and provide fatigue resistance.

[0145] The proximal end of the expandable portion of the scored sheath 2000 further includes an instrument introduction region 1300, which is used to guide an instrument that applies an expansion force into the lumen of the tubular body 1000. If necessary, the scored sheath 2000 may further include other functional structures in the tubular body 1000, such as a wire 1500.

[0146] In some specific embodiments, the present invention further provides an auxiliary introduction structure for conveniently exchanging intracavitary instruments with the scored sheath (1000 / 2000); the auxiliary introduction structure can also be deployed on any cage-type exoskeleton to facilitate the rapid exchange of other instruments (such as balloon catheters and balloon introduction tubes) into the cage-type exoskeleton cavity. Figures 22 to 35As shown, a medical device includes a cage-type exoskeleton (such as a notched sheath 1000 / 2000) for being sheathed on the device; an instrument introduction port (such as an oblique port 1310, or other non-oblique ports) is provided at the proximal end of the cage-type exoskeleton, through which the device can enter or withdraw from the inner cavity of the cage-type exoskeleton; a longitudinally extending progressive introduction structure (such as progressive introduction structures 401-407) is provided near the device introduction port, which is formed by hollowing out a curved solid body to form a plurality of ribs; the progressive introduction structure can adapt to the radial increase of the initial geometric size of the device introduction port relative to the initial geometric size (such as the balloon introduction tube 700 sheathed outside the balloon catheter in the storage state, whose initial diameter size is 200). The progressive introduction structure is often larger than the size of the instrument introduction port of the scored sheath, and the seams, ribs or bifurcated units of the progressive introduction structure can passively expand 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 seams (1330 / 1331 / 1332 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338) with different expansion properties. Expansion performance includes: 1) Expansion ratio: the ratio of the maximum diameter of the progressive introduction structure after expansion to its initial diameter. A high expansion ratio means that the progressive introduction structure can adapt to the introduction of larger instruments; 2) Expansion uniformity: during the expansion process, each part of the progressive introduction structure can expand evenly to avoid local over-expansion or deformation; 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 slit 1330 and the expansion gap at the proximal end / middle of transition slit 1331 are substantially the same size (i.e., they can expand evenly). 3) Force transmission efficiency: The progressive introduction structure ensures a continuous and smooth introduction of the balloon introduction tube 700. This structure ensures the rigidity of the push structure (the push force is evenly distributed to the working ribs) and the uniform contraction of the force during withdrawal. 4) Resilience: The progressive introduction structure can quickly return to its original state even when multiple expansions and contractions are required, thereby ensuring or not affecting the function of the cage-like exoskeleton (such as the scored segment of a scored sheath). In particular, when one end of the rib near the proximal end of the scored segment is desired to be constrained / restrained from radial expansion, it is crucial to guide the progressive introduction structure to expand in stages to accommodate the outer dimensions of the balloon introduction tube 700 (or other device), while ensuring that the proximal end of the scored segment is constrained, thereby allowing for the longitudinal deployment of the first and second types of ribs (or slits with different expansion properties). The slits with different expansion properties can be arranged in a staggered manner around the axis, or arranged adjacently / at intervals in the longitudinal direction; the gaps between the slits can be different in size, or the shapes of the slits can be different; no matter the arrangement between the slits, the gap size arrangement, or the slit shape arrangement, the purpose is to enable the progressive introduction structure to achieve different expansion properties in the longitudinal direction (such as Figures 22 to 28 By adjusting / designing the gap and shape of the slits, the longitudinal density of the ribs, and the longitudinal deployment of the bifurcated units, different progressive introduction structure designs can be formed. Compared to the open-loop thrombectomy stent 300 with the slit 310 extending through both ends, in most cases, the distal end / distal segment of these progressive introduction structures has a closed loop structure (i.e., in the circumferential direction, the connection between the ribs and the segments forms a continuous loop structure, or the connection between the ribs forms a continuous loop structure); Figures 22 to 28 In the figure, closed-loop connection point 1304 is connected to closed-loop connection point 1305 to form a closed-loop connection at the distal end of the progressive introduction structure. This closed-loop structure ensures the desired constraint of the proximal end of the scored segment of the scored sheath. The progressive introduction structure ensures a more uniform force transmission path during the push and pull process, making push and pull easier. The entire scored sheath will not experience problems such as local knotting, excessive opening in one area and insufficient opening in another, and uneven stepping.

[0147] Assuming that the progressive lead-in structure is made by etching a circular tube, the circumference of the circular tube is d, and the same type of rib area is divided into n equal parts, then d ribs + d gaps = d / n in each type of rib area, equation ①, the rib length is L nDuty cycle η = d ribs / (d ribs + d gaps) Equation ②, where 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 thickness direction of the tube wall, 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 reinforcement area is P, then the force value of a single reinforcement is F = P / n equation ⑤. Solving equations ①-⑤ simultaneously, the deformation capacity of a single reinforcement y = (4·P·L n 3 ·n 2 ) / (h·((d 筋条 +d 缝隙 )·n·η) 3 ); total deformation capacity Y = ny. The deformation caused by unit force is defined as 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 ring's ability to expand and deform. The larger the K value, the easier it is to deform overall; the smaller the K value, the harder it is to deform.

[0148] 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.

[0149] 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. Furthermore, 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).

[0150] Furthermore, in some specific embodiments, Figure 29 and Figure 30 As shown, some of the second-class ribs have a spiral shape extending around the centerline of the cage-like exoskeleton. Unlike the axial horizontal-vertical rib structure of a typical hypotube, the spatial spiral shape of these ribs can evenly distribute the force when pushing and pulling the scored sheath, thereby improving the push and pull performance.

[0151] Furthermore, in some specific embodiments, Figures 22 to 28 As shown, the number of the second branched units is less than the number of the first branched units.

[0152] Furthermore, in some specific embodiments, Figures 22 to 28 and Figures 33 and 34 As shown, it also includes a hollowed-out seam 1330 between two ribs; a transition seam (1331 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338) between two second-type ribs, the gap near its distal end is larger than the gap near its proximal end, and its distal end is connected to the first-type rib seam; the gap of the first-type rib seam is smaller than or equal to the proximal gap of the second-type rib seam. The transition seam is usually designed to span two or more types of ribs, or span across both ends of a section; the transition seam usually also has a morphology / shape in which the local gap is larger than other gaps; the transition seam is usually 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 evenly distribute the expansion gaps at both ends of the progressive introduction structure (such as Figure 35 13. In the expanded state of the progressive introduction structure, the distal expansion gap of the slit 1330 is substantially the same as the proximal / middle expansion gap of the transition slit 1331. In some progressive introduction structures, such as Figure 25 As shown in the figure, four types of ribs (1340 / 1350 / 1360 / 1390) are deployed longitudinally, which makes the progressive introduction structure have a longer gradual guide stroke and effectively suppresses the abrupt change of the expansion trend. In some progressive introduction structures, such as Figure 28 As shown, two types of ribs (1350 / 1360) are deployed longitudinally; compared with other forms of progressive introduction structures, this structure shortens the guide stroke to increase the convenience of the exchange operation. In some progressive introduction structures, not shown in the figure, only one rib with better expansion performance than the cage exoskeleton body can be deployed; in such structures, the gap of the progressive introduction structure is larger than the gap of the cage exoskeleton body. In some progressive introduction structures, such as Figure 27 and Figure 34 As shown, this type of progressive introduction structure typically has a gap 1332 that is not interconnected with the main cage exoskeleton seam to ensure the restraint of the proximal ribs of the main cage exoskeleton. The expansion performance of this type of progressive introduction structure is typically independent of the expansion performance of the main cage exoskeleton. The gap 1332 typically appears larger at one end than at the other.

[0153] Furthermore, in some specific embodiments, Figures 26 to 30As shown, it also includes an annular unit 1370 with an opening, which is arranged on the proximal end or proximal segment of the progressive introduction structure; the diameter of the annular hole of the annular unit 1370 can be adaptively increased; the annular unit includes two half rings fixed to each other at one end, and the other end of the half ring is a free end 1371 / 1372; definition: the outer diameter 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, the progressive introduction structure will bend downward at the front end under certain stress conditions, making it difficult for the instrument to enter the lumen of the progressive introduction structure; the annular unit 1370 of the present invention can maintain a semi-enclosed shape (i.e., a shape that half-hoops the outer contour of the instrument) during the process of introducing the instrument, i.e., L≥π·D / 2. The design advantage of the annular unit 1370 is that the half-ring structure allows the progressive introduction structure (i.e., the instrument introduction area 1300) to always have a portion of the half-ring fastened to the instrument at the free end 1371 / 1372 during the expansion process, making the introduction of the instrument smoother and avoiding the occurrence of the "downward pressure head" phenomenon at the head end.

[0154] Furthermore, in some specific embodiments, Figures 29 and 30 As shown, one side of the free end 1371 / 1372 of the semi-ring is fixed to the rib; the annular unit 1370 is arranged at an angle to the centerline of the cage-type outer frame. The annular unit includes a first annular unit and a second annular unit 1380; the semi-ring free end of the first annular unit and the semi-ring free end of the second annular unit 1380 are fixed to each other.

[0155] Furthermore, in some specific embodiments, the device is one or a combination of a catheter, a balloon catheter, a drug-coated balloon catheter, and a guidewire.

[0156] Furthermore, in some specific embodiments, the cage exoskeleton is one or a combination of a dense mesh stent, a scored sheath, and a balloon exoskeleton.

[0157] In some specific embodiments, the applicant unexpectedly discovered that: under different radial expansion sizes (non-plastic expansion), the scoring unit 500 (such as the pressure focusing group unit 1400 / pressure focusing unit 1600) for the concentrated pressure action surface of the scoring sheath (1000 / 2000) has a deflection angle that falls within a range of greater than or equal to 45 degrees and less than or equal to 90 degrees, and the deflection angle within this range is conducive to the concentrated pressure scoring effect. The present invention also provides: Figures 36 to 39As shown, a rapid exchange scoring sheath includes a tubular body having an inner cavity and a tube wall; the inner cavity can accommodate a balloon catheter that applies an expansion force; the tube wall has a plurality of hollow slits 1210, and ribs 1220 and nodes (1230 / 1231 / 1232) formed by the array of slits; the node is fixed between two ribs, and the longitudinal dimension of the node is smaller than the longitudinal dimension of the rib; the tubular body has an initial state 501 with an initial radial dimension, and an expanded state with an increased radial dimension relative to the initial radial dimension; in the expanded state, some scoring units 500 for concentrating the pressure acting surface (such as pressure focusing group unit 1400 / pressure focusing group unit 1400) are provided. The force focusing unit 1600 has a deflection shape in which one side 506 is 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 line connecting the two side surfaces 506 / 507); the expansion state includes a first expansion state and a second expansion state, and the radial dimension value of the second expansion state is greater than the radial dimension value of the first expansion state; the deflection angle of the scoring unit 500 in the first expansion state is greater than or equal to 45 degrees and less than or equal to 90 degrees; and / or, the deflection angle of the scoring unit 500 in the second expansion state is greater than or equal to 45 degrees and less than or equal to 90 degrees. Furthermore, when the expansion ratio of the scored segment 1200 of the scored sheath (1000 / 2000) is within the range of 1.5 to 15, 2 to 10, or 3 to 6, the deflection angle of the first expanded state and the second expanded state is greater than or equal to 45 degrees and less than or equal to 90 degrees; when the expansion ratio of the scored segment 1200 of the scored sheath (1000 / 2000) is 2, 4, 6, 8, and 10, the deflection angle of the first expanded state and the second expanded state is greater than or equal to 45 degrees and less than or equal to 90 degrees. The deflection angle of the scored unit remains basically the same or remains within basically the same range under different radial expansion sizes (non-plastic expansion), which is conducive to the flexible application or compatibility of the scored sheath (1000 / 2000) for the treatment of lumens of various sizes; this significantly reduces the treatment cost of patients.

[0158] In some embodiments, the scoring unit 500 of the rapid-exchange scoring sheath includes ribs, segments, or a combination thereof.

[0159] In some specific embodiments, Figure 40 As shown, in the expanded state, some of the ribs that are scoring units have protrusions or teeth 600 facing outward away from the axis 505.

[0160] In some specific embodiments, the rapid exchange notched sheath is provided near the proximal end of the tubular body with an exchange port (i.e., oblique port 1310) formed by a slit in the wall of the tubular body. The exchange port is used for quickly introducing a balloon catheter into the inner cavity of the tubular body; and / or, the exchange port is used for convenient exchange of the balloon catheter in the inner cavity of the tubular body; the surface where the exchange port is located is set at an inclined angle to the axis of the tubular body.

[0161] In some specific embodiments, the tube wall segment used to form the exchange port of the rapid exchange notched sheath includes a distally extending manifold unit 1320 and transition seams (1331 / 1333 / 1334 / 1335 / 1336 / 1337 / 1338). The manifold unit 1320 is used to guide the balloon catheter 200 into the lumen of the tubular body, and the transition seams are used to guide the exchange port toward the distal end of the tubular body to adapt to or conform to the deformation trend of the initial size of the guide balloon catheter. The manifold unit has a shape that combines two or more ribs into a single rib. The manifold unit and the transition seams constitute a progressive introduction structure (i.e., the instrument introduction area 1300).

[0162] In some specific embodiments, a slender rod (ie, wire 1500 ) for pushing or pulling the tubular body is provided at the proximal end of the rapid exchange scoring sheath tubular body.

[0163] In some embodiments, the rapid-exchange scoring sheath includes a non-expandable region 1100 disposed at the distal end of the tubular body, at one end of a radially restraining rib. The non-expandable region includes a smoothly tapered tip affixed to the tubular body. The tip is a polymer with a developable surface. The polymer is preferably a polyether block amide with 35% BaSO₄.

[0164] The present invention also provides a method: Figure 39 As shown, a peripheral vascular scoring catheter includes a rapid-exchange scoring sheath and a balloon catheter. The scoring unit is longitudinally and circumferentially arranged on a tubular body to form a scoring segment. The scoring segment 1200 has a longitudinal length of 10 to 350 mm. The balloon catheter includes a balloon body 200 supported on the distal end of the catheter. The longitudinal length of the balloon body is less than or equal to the longitudinal length of the scoring segment 1200.

[0165] Peripheral vascular scoring catheters include balloon catheter sets with different expansion diameters and / or balloon catheter sets with different longitudinal lengths. Typically, balloon catheters are configured with balloon diameters of 1.5-15 mm and lengths of 10-320 mm, or balloon catheters of 5 French or larger.

[0166] Peripheral vascular scoring catheters may also include medicated balloon catheters.

[0167] The filling of the balloon body 200 causes the scoring segment 1200 to be in an expanded state. Some scoring units 500 of the peripheral vascular scoring catheter face away from the surface 506 of the outer surface of the balloon, and the height H1 from the outer surface of the balloon is 0.05-5 mm.

[0168] The peripheral vascular scoring catheter includes a tubular balloon introduction tube 700 (such as Figure 42 As shown), one end of the balloon introduction tube 700 has an inclined opening; the balloon introduction tube 700 is sleeved outside the balloon catheter to assist the balloon catheter in being introduced into the inner cavity of the rapid exchange notched sheath.

[0169] The peripheral vascular scoring catheter is used to dilate the internal stenosis of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, subpopliteal artery, and renal artery; or to dilate the stenosis of autologous or artificial arteriovenous dialysis fistula.

[0170] In some specific embodiments, the present invention provides a peripheral vascular scoring catheter consisting of a tip, a scoring segment, a traction wire, a fixing seat, and a balloon introduction tube. The tip of the peripheral vascular scoring catheter is soft and has a certain taper, making it easy to pass through and reach the stenosis. The peripheral vascular scoring catheter needs to be combined with a commercially available balloon catheter and used after being assembled in vitro. The tip: is used to track the guide wire through the blood vessel and enter the lesion site; the tip is smooth and tapered, making it easy to pass through and reach the stenosis site, and the material itself has visualization properties. Scoring segment: The scoring segment can be expanded by balloon inflation, low-pressure dilation of the lesion site, and blood circulation is restored. Traction wire: is used to pull and withdraw the device. Balloon introduction tube: The balloon introduction tube is used to introduce the balloon catheter to form a combined device. The peripheral scoring catheter can be adapted to 0.014", 0.018", and 0.035" series, and is adapted to peripheral balloon dilation catheters with an effective balloon length of 20 to 220 mm or 10 to 320 mm and a balloon diameter of 3 to 8 mm.

[0171] Advantages of peripheral vascular scoring catheters:

[0172] 1) Compatible with guidewires of various specifications (0.014”-0.035”), and can adapt to 5F and 6F balloons with lengths of 40-120mm.

[0173] 2) Excellent therapeutic effect: During the dilation process, the sheath wicks slowly stand up and apply a gradually increasing stress concentration force to the plaque. The final cutting effect is comparable to that of the blade-type cutting balloon with excellent therapeutic performance on the market. In addition, this form of action without sudden changes in force causes less damage to the blood vessel wall.

[0174] 3) The interventional process is safe and reliable, with an integrated sheath design. In the non-expanded state, the entire structure is similar to a sheath, causing less damage to the blood vessel wall during delivery or withdrawal. When using a drug balloon to treat lesions, if the drug falls off during delivery, it will be flushed by the blood flow. The detached drug may damage the peripheral nerves and cause nerve damage. 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 medicine balls to increase the utilization rate of drugs.

[0175] 4) Convenience of operation: the angiography window can be used to observe / monitor vasodilation and postoperative treatment effects at any time.

[0176] 5) The original material of the notched sheath can be made of stainless steel, Co-Cr alloy, and nickel-titanium alloy, and has excellent market competitiveness.

[0177] 6) This structure takes into account the safety during the delivery process and is safer during the delivery process than the cutting balloon.

[0178] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical principles disclosed herein are intended to be covered by the claims of the present invention.

Claims

1. A rapid exchange scoring sheath, comprising a tubular body having an inner lumen and a tubular wall; the inner lumen being capable of accommodating a balloon catheter for applying an expansion force; the tubular wall having a plurality of hollowed-out slits, and ribs and nodes formed by an array of slits; a node being fixed between two ribs, and having a longitudinal dimension smaller than that of the ribs; the tubular body having an initial state with an initial radial dimension, and an expanded state with an increased radial dimension relative to the initial radial dimension; characterized in that: In the expanded state, some notched units for gathering pressure action surfaces have a deflection shape with one side away from the axis relative to the initial state and a deflection angle relative to the initial state; the expanded state includes a first expanded state and a second expanded state, and the radial dimension value of the second expanded state is greater than the radial dimension value of the first expanded state; the deflection angle of the notched unit in the first expanded state is greater than or equal to 45 degrees and less than or equal to 90 degrees; and / or, the deflection angle of the notched unit in the second expanded state is greater than or equal to 45 degrees and less than or equal to 90 degrees.

2. The rapid exchange scoring sheath according to claim 1, characterized in that The scoring unit includes one or a combination of ribs and nodes.

3. The rapid exchange scoring sheath according to claim 2, characterized in that In the expanded state, some of the ribs that are notched units have protrusions or teeth facing outward away from the axis.

4. The rapid exchange scoring sheath according to claim 1, characterized in that Near the proximal end of the tubular body, there is an exchange port formed by a slit in the wall of the tubular body. The exchange port is used for quickly introducing a balloon catheter into the inner cavity of the tubular body; and / or, the exchange port is used for conveniently exchanging the balloon catheter in the inner cavity of the tubular body; the surface where the exchange port is located is set at an inclined angle to the axis of the tubular body.

5. The rapid exchange scoring sheath according to claim 4, characterized in that The tube wall section with the exchange port includes a bifurcated unit and a transition seam extending toward the distal end; the bifurcated unit is used to guide the balloon catheter into the inner cavity of the tubular body, and the transition seam is used to guide the exchange port toward the distal end of the tubular body to adapt to or follow the deformation trend of the initial size of the balloon catheter; the bifurcated unit has a shape that converges two or more ribs into one rib.

6. The rapid exchange scoring sheath according to claim 1, characterized in that The proximal end of the tubular body is provided with a slender rod for pushing or pulling the tubular body.

7. The rapid exchange scoring sheath according to claim 1, characterized in that It includes a non-expanded area at one end of a radial limiting rib arranged at the distal end of the tubular body.

8. The rapid exchange scoring sheath according to claim 1, characterized in that The non-expanded area is provided with a tapered head with a smooth end fixed to the tubular body. The tapered head is made of polymer and has developability.

9. A peripheral vascular scoring catheter comprising the rapid exchange scoring sheath according to any one of claims 1 to 8, and a balloon catheter.

10. The peripheral vascular scoring catheter according to claim 9, characterized in that: The scoring unit is longitudinally and circumferentially deployed on the tubular body to form a scoring segment; the longitudinal length of the scoring segment is 10 to 350 mm; the balloon catheter includes a balloon body supported on the distal end of the catheter; the longitudinal length of the balloon body is less than or equal to the longitudinal length of the scoring segment.

11. The peripheral vascular scoring catheter according to claim 10, characterized in that: The invention also provides a balloon catheter group having different expanded diameters; and / or a balloon catheter group having different longitudinal lengths.

12. The peripheral vascular scoring catheter according to claim 10, characterized in that: Includes a balloon catheter with medication.

13. The peripheral vascular scoring catheter according to claim 10, characterized in that: The balloon body is filled so that the scored segment is in an expanded state, and some scored units are away from the outer surface of the balloon body, with a height of 0.05 to 5 mm from the outer surface of the balloon body.

14. The peripheral vascular scoring catheter according to claim 9, characterized in that The invention comprises a tubular balloon introduction tube, one end of which is provided with an inclined opening; the balloon introduction tube is sleeved outside the balloon catheter and assists the balloon catheter in being introduced into the inner cavity of the rapid exchange notched sheath.

15. The peripheral vascular scoring catheter according to claim 9, characterized in that The peripheral vascular scoring catheter is used to dilate the internal stenosis of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, subpopliteal artery, and renal artery; or to dilate the stenosis of autologous or artificial arteriovenous dialysis fistula.

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