Medical instrument

Abstract

The invention provides a medical instrument which comprises a cage type outer skeleton used for being arranged on the instrument in a sleeving mode, an instrument leading-in opening is formed in the near end of the cage type outer skeleton, and the instrument can enter or exit from an inner cavity of the cage type outer skeleton through the instrument leading-in opening; a progressive leading-in structure which is provided with a plurality of ribs and extends longitudinally is arranged close to the instrument leading-in opening, and the curved-surface solid is hollowed out to form the plurality of ribs; the gradual leading-in structure can adapt to the radial increasing change of the instrument leading-in opening relative to the initial geometric dimension; the progressive lead-in structure comprises a first type of ribs and a second type of ribs which have different expansion properties; the first type of ribs and the second type of ribs are longitudinally arranged; the ribs of the same type are arranged in the circumferential direction; and / or the progressive lead-in structure comprises seams with different expansion properties. According to the medical instrument provided by the invention, the gradual lead-in structure is arranged, so that the requirement of replacing peripheral special balloon products with different models, specifications / sizes under the scene of lumens with various sizes is met.

Description

Technical Field

[0001] The present invention relates to an interventional medical device, in particular to a medical device. Background Art

[0002] Vascular disease is one of the leading factors threatening human health worldwide. With the acceleration of aging, the number of patients with peripheral arterial disease continues to increase.

[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 can be used in lumens of various sizes, has strong compatibility, simple process, and high efficiency of force concentration and scoring. Summary of the Invention

[0012] In view of the shortcomings of the prior art described above, the purpose of the present invention is to provide a scored sheath, which, on the one hand, solves the problem in the prior art of needing to replace special peripheral balloon products of different models, specifications / sizes in scenarios with multiple lumen sizes, and on the other hand, solves the problem that the traditional scored grid cannot reduce the pressure application surface of the hollow anatomical structure in the longitudinal direction.

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

[0014] The present invention provides a medical device, comprising a cage-type exoskeleton for being sleeved on the device, wherein the proximal end of the cage-type exoskeleton is provided with an instrument introduction port, through which the device can enter or withdraw from the inner cavity of the cage-type exoskeleton; a longitudinally extending progressive introduction structure is provided near the instrument introduction port, wherein the progressive introduction structure is formed by hollowing out a curved solid body to form a plurality of ribs; the progressive introduction structure can adapt to radial increases in the geometric dimensions of the device introduction port relative to an initial dimension; the progressive introduction structure includes a first type of ribs and a second type of ribs having different expansion properties; the first type of ribs and the second type of ribs are arranged longitudinally; ribs of the same type are arranged circumferentially; and / or the progressive introduction structure includes slits having different expansion properties.

[0015] In some embodiments, the second type of tendons has a greater expansion performance than the first type of tendons.

[0016] In some embodiments, one second-type rib is fixedly connected to two or more first-type ribs to form a first bifurcated unit.

[0017] In some embodiments, some of the second type of ribs have a shape that extends helically around the centerline of the cage exoframe.

[0018] In some embodiments, a third type of rib is further included, and one third type of rib is fixedly connected to two or more second type of ribs to form a second bifurcated unit.

[0019] In some embodiments, the number of the second branched units is less than the number of the first branched units.

[0020] In some embodiments, it also includes a hollowed-out seam between two ribs; the seam between two second-type ribs has a gap larger near its distal end than near its proximal end, and its distal end is connected to the seam of the first-type rib; the gap of the first-type rib seam is smaller than or equal to the proximal gap of the second-type rib seam.

[0021] In some embodiments, the invention further comprises an annular unit having an opening and disposed at the proximal end or proximal segment of the progressive introduction structure; the diameter of the annular hole of the annular unit can be adaptively increased; the annular unit comprises two half rings fixed to each other at one end, and the other end of the half ring is a free end;

[0022] Definition: The outer diameter of the device is D. After the annular unit accommodates the device, the distance between the free ends of the two half rings is L. Then the condition L ≥ π·D / 2 is satisfied.

[0023] In some embodiments, one side of the free end of the semi-ring is fixed to the rib; the annular unit is arranged obliquely to the center line of the cage-type outer frame.

[0024] In some embodiments, the annular unit includes a first annular unit and a second annular unit; a semi-ring free end of the first annular unit and a semi-ring free end of the second annular unit are fixedly connected to each other.

[0025] In some embodiments, the medical device is one or a combination of a catheter, a balloon catheter, a drug-coated balloon catheter, and a guidewire.

[0026] In some embodiments, the cage exoskeleton is one or a combination of a dense mesh stent, a scored sheath, and a balloon exoskeleton.

[0027] The medical device provided by the present invention meets the demand for replacing peripheral special balloon products of different models, specifications / sizes in various lumen scenarios through the setting of a progressive introduction structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Shown is a schematic diagram of the three-dimensional structure of an embodiment of the medical device of the present invention.

[0029] 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.

[0030] Figure 3 Display as Figure 2 Schematic diagram of the state of the pressure focusing group unit 1400 in the scoring segment 1200 when it is not expanded.

[0031] Figure 4 Display as Figure 2 Schematic diagram of the deflection shape of the pressure focusing group unit 1400 in the scoring segment 1200 when it expands.

[0032] Figure 5 It is a schematic diagram showing the morphological change of the pressure focusing group unit 1400 from non-expanded to expanded.

[0033] Figure 6 Display as Figure 4 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.

[0034] Figure 7 Display as Figure 4 Actual image of the deflection shape of the pressure focusing group unit 1400 when expanded.

[0035] 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.

[0036] Figure 9 Shown is a pictorial diagram of the deflected configuration of the pressure focusing group unit 1400.

[0037] 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.

[0038] Figure 11 Shown is a schematic diagram of the distal local structure of a medical device.

[0039] Figure 12 Shown is a schematic diagram of the proximal local structure of a medical device.

[0040] Figure 13 Display as Figure 1 Schematic diagram of the assembly of the scored sheath and balloon catheter.

[0041] Figure 14 It shows a schematic diagram of a partial two-dimensional planar unfolded structure of the notched segment 1200 in a natural state with the ribs on both sides of the segment being folded and flipped sideways according to the present invention.

[0042] Figure 15 Display as Figure 14 Schematic diagram of the deflected shape of the expandable part after expansion.

[0043] 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.

[0044] Figure 17 A schematic diagram of the local deflection structure showing opposite flipping directions of the ribs at different node elements.

[0045] 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.

[0046] Figure 19 Display as Figure 15 Schematic diagram of the shape and position of each rib in the transverse section in the deflected state.

[0047] Figure 20 Shown is a schematic diagram of the three-dimensional structure of an open-loop thrombectomy stent in the prior art.

[0048] Figure 21A schematic diagram showing the relationship between the gap and rib areas when the imported structure is unfolded in its natural state.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] Figure 31 Shown is one of the schematic diagrams of the unit structure.

[0059] Figure 32 Shown is the second schematic diagram of the subunit structure.

[0060] Figure 33 Shown is the third schematic diagram of the subunit structure.

[0061] Figure 34 Shown is the fourth schematic diagram of the unit structure.

[0062] Figure 35 Shown is one of the schematic diagrams of the transition joint structure in the progressive introduction structure.

[0063] Figure 36 Schematic diagram showing the seam structure in the progressive introduction structure that is not interconnected / connected with the main seam of the cage exoskeleton.

[0064] Figure 37 Shown is the second schematic diagram of the transition joint structure in the progressive introduction structure.

[0065] Figure 38 Schematic diagram showing the expanded state of the structure with gradual introduction.

[0066] Figure 39 Schematic diagram showing the deflection configuration of the scoring unit 500 in a rapid exchange scoring sheath according to the present invention.

[0067] Figure 40 Shown is a schematic diagram of the three-dimensional structure of a rapid exchange scoring sheath of the present invention.

[0068] Figure 41 Schematic diagram showing the configuration of a balloon catheter adapted for use with a rapid exchange scored sheath.

[0069] Figure 42 Shown is a schematic diagram of the three-dimensional structure of a peripheral vascular scoring catheter of the present invention.

[0070] Figure 43 It shows a schematic diagram of a three-dimensional structure of a scoring segment with protrusions or teeth 600 according to the present invention.

[0071] Figure 44 It is a highly schematic diagram of the scoring unit 500 of the present invention after being turned over.

[0072] Figure 45 Shown is a three-dimensional structural schematic diagram of a balloon introduction tube 700 used in conjunction with a peripheral vascular scoring catheter according to the present invention.

[0073] Figure 46 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. DETAILED DESCRIPTION

[0074] 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.

[0075] See also Figures 1 to 46. 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.

[0076] 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.

[0077] 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 medical device (such as the scored sheath); and the circumferential direction is the direction of a circle around the axis of the medical device (such as the scored sheath).

[0078] 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 46 As shown: a problem of a progressive scoring line 800 where several points 801 gradually extend to form a line.

[0079] In order to realize the functions of the above-mentioned medical device (such as the 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.

[0080] Regarding the scoring segment structural design of medical devices (such as scoring sheaths): by exchanging balloons 200 of different sizes (such as length / size), the lesion site can be inflated and expanded at low pressure to restore blood circulation and achieve the purpose of one sheath with multiple uses. The scoring segment structure 1200 is the key structure for the scoring sheath to achieve safe and efficient scoring or cutting functions. Through the special size design of the ribs 1220 and the nodes 1230, the ribs 1220 of the scoring sheath are induced to become unstable during expansion. The unstable 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 18 As shown); Compared with the undeflected ribs, these ribs / sections with deflected morphologies 1400 / 1600 can further reduce the pressure acting on the inner wall of the hollow anatomical structure, thereby achieving the purpose of force-concentrated scoring / cutting; in particular, the deflected morphology 1400 can exert pressure on the hollow anatomical structure in the longitudinal direction, which is a progressive scoring that gradually extends from several points to form a line, such as Figure 46As 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.

[0081] Regarding the same direction of the ribs turning over (such as Figures 2 to 9 As shown): The notch section is distributed indirectly; the structural design induces the designated ribs 1221 / 1222 to turn upward or relatively downward at the expansion section 1230, such as Figure 5 As shown in FIG, after expansion, the deformation can be a convex section (upward) and a concave section (downward pressure); Figure 6 As shown, during the expansion process, the upper rib 1222 is gradually lifted up, and the rib flips upward to contact the plaque and cut the plaque; the lower rib 1221 is gradually pressed down, and the rib flips downward to directly contact the balloon 200; this structural design 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 rib / node to become unstable and flip, and the resistance required to overcome in the thickness direction to expand and deform, much smaller than the resistance required to overcome in the width direction; after completing this configuration, the rib / node will flip / deflect as the balloon expands, and as the balloon diameter increases, the ribs are further pulled apart to accommodate a 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.

[0082] 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 tension 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 tension 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.

[0083] Regarding the design of rapid exchange structure of medical devices (such as notched sheaths) Figures 22 to 38As 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.

[0084] 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.

[0085] In some specific embodiments, the present invention provides a medical device: comprising a scored sheath tube (such as 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 46 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 39 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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 .

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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 .

[0095] 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.

[0096] The instrument introduction region 1300 includes a bevel 1310 that is angled obliquely to the axis of the tubular body.

[0097] 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.

[0098] In some embodiments, a drug coating is disposed on the wall of tubular body 1000 .

[0099] In some specific embodiments, the present invention provides another medical device (such as Figures 14 to 19 As shown): a scoring sheath 2000 comprising ribs on both sides of the section folded and turned sideways. A scoring 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.

[0100] 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).

[0101] 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.

[0102] 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.

[0103] 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 .

[0104] 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.

[0105] 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.

[0106] In some specific embodiments, the present invention further provides a medical device: comprising an auxiliary introduction structure for conveniently exchanging intracavitary devices with a scored sheath (1000 / 2000); the auxiliary introduction structure can also be deployed on any cage-type exoskeleton to facilitate the quick exchange of other devices (such as balloon catheters, balloon introduction tubes) into the cage-type exoskeleton cavity. Figures 22 to 38As 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 38As 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.

[0107] 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 gap)·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.

[0108] 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.

[0109] Furthermore, in some specific embodiments, Figure 31 As shown, one second-type rib is fixedly connected to two or more first-type ribs to form a first bifurcated unit 1320 .

[0110] 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.

[0111] Furthermore, in some specific embodiments, Figures 32 to 34 As shown, it also includes a third type of rib, and one third type of rib is fixedly connected to two or more second type of ribs to form a second bifurcated unit (1321 / 1322 / 1323).

[0112] 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.

[0113] Furthermore, in some specific embodiments, Figures 22 to 28 and Figures 35 to 37 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 38 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 36 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] In some specific embodiments, the applicant unexpectedly discovered that: in medical devices such as scored sheaths (1000 / 2000), under different radial expansion sizes (non-plastic expansion), the deflection angles of the scored units 500 (such as the pressure focusing group unit 1400 / pressure focusing unit 1600) used for the concentrated pressure action surface all fall within the range of greater than or equal to 45 degrees and less than or equal to 90 degrees, and the deflection angles within this range are conducive to the concentrated pressure scoring effect. The present invention also provides: Figures 39 to 42As 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.

[0119] In some embodiments, the scoring unit 500 of the rapid-exchange scoring sheath includes ribs, segments, or a combination thereof.

[0120] In some specific embodiments, Figure 43 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.

[0121] 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.

[0122] 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).

[0123] 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.

[0124] 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.

[0125] The present invention also provides a method: Figure 42 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.

[0126] 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.

[0127] Peripheral vascular scoring catheters may also include medicated balloon catheters.

[0128] 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.

[0129] The peripheral vascular scoring catheter includes a tubular balloon introduction tube 700 (such as Figure 45 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.

[0130] 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.

[0131] 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.

[0132] Advantages of peripheral vascular scoring catheters:

[0133] 1) Compatible with guidewires of various specifications (0.014”-0.035”), and can adapt to 5F and 6F balloons with lengths of 40-120mm.

[0134] 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.

[0135] 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.

[0136] 4) Convenience of operation: the angiography window can be used to observe / monitor vasodilation and postoperative treatment effects at any time.

[0137] 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.

[0138] 6) This structure takes into account the safety during the delivery process and is safer during the delivery process than the cutting balloon.

[0139] 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 medical device, comprising a cage-type exoskeleton for sleeved on the device, characterized in that: An instrument introduction port is provided at the proximal end of the cage exoskeleton, through which instruments can enter or withdraw from the inner cavity of the cage exoskeleton; a longitudinally extending progressive introduction structure is provided near the instrument introduction port, with a plurality of ribs formed by hollowing out a curved solid; the progressive introduction structure can adapt to changes in the radial increase of the instrument introduction port relative to the initial geometric dimensions; the progressive introduction structure includes a first type of ribs and a second type of ribs with different expansion properties; the first type of ribs and the second type of ribs are arranged longitudinally; ribs of the same type are arranged circumferentially; and / or the progressive introduction structure includes seams with different expansion properties.

2. The medical device according to claim 1, characterized in that: The expansion performance of the second type of reinforcement is greater than that of the first type of reinforcement.

3. The medical device according to claim 2, characterized in that: One second-type rib is fixedly connected to two or more first-type ribs to form a first bifurcated unit.

4. The medical device according to claim 3, characterized in that: Some of the second type of ribs have a configuration that extends helically around the centerline of the cage exoframe.

5. The medical device according to claim 3, characterized in that: It also includes a third type of rib, where one third type of rib is fixedly connected to two or more second type of ribs to form a second bifurcated unit.

6. The medical device according to claim 5, characterized in that: The number of the second branched units is less than the number of the first branched units.

7. The medical device according to claim 1, characterized in that: It also includes a hollowed-out seam between two ribs; the seam between two second-type ribs has a gap larger near its distal end than near its proximal end, and its distal end is connected to the seam of the first-type rib; the gap of the first-type rib seam is smaller than or equal to the proximal gap of the second-type rib seam.

8. The medical device according to claim 1, characterized in that: The invention also includes an annular unit with an opening, which is arranged at the proximal end or proximal end section of the progressive introduction structure; the diameter of the annular hole of the annular unit 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; Definition: The outer diameter of the device is D. After the annular unit accommodates the device, the distance between the free ends of the two half rings is L. Then the condition L ≥ π·D / 2 is satisfied.

9. The medical device according to claim 8, characterized in that: One side of the free end of the semi-ring is fixedly connected to the rib; the annular unit and the center line of the cage-type outer frame are arranged obliquely.

10. The medical device according to claim 9, characterized in that: The annular unit comprises a first annular unit and a second annular unit; a semi-annular free end of the first annular unit and a semi-annular free end of the second annular unit are fixedly connected to each other.

11. The medical device according to claim 1, characterized in that: The device is one or a combination of a catheter, a balloon catheter, a drug-coated balloon catheter, and a guidewire.

12. The medical device according to claim 1, characterized in that: The cage exoskeleton is one or a combination of a dense mesh stent, a scored sheath, and a balloon exoskeleton.

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