An interventional device

Abstract

The application provides an interventional device which is inserted into a target lumen comprising several predetermined regions, the predetermined regions being at least partially curved; the interventional device comprises a tubular member having a plurality of rings and a plurality of beams, the beams connecting the plurality of rings; except for one ring located at a designated end of the tubular member, the other part of the tubular member comprises a plurality of repeating units, each repeating unit comprising at least one ring and a beam connected to the ring and extending towards the designated end; the rotation offset between two adjacent repeating units; the tubular member comprises several sub-segments, each sub-segment being arranged in a predetermined region; the length L of the repeating unit located in any sub-segment, the angle a of the rotation offset between two adjacent repeating units located in the sub-segment and the minimum curvature K of the predetermined region corresponding to the sub-segment satisfy the relationship: the interventional device determines the cutting parameters of the tubular member according to the relevant parameters of the target lumen, which is beneficial to the distal end of the interventional device to reach the target position.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an interventional device. BACKGROUND

[0002] Cardiovascular and cerebrovascular diseases seriously affect people's physical health and quality of life. Vascular interventional surgery is an important means of treating cardiovascular and cerebrovascular diseases, which has the advantages of small trauma, rapid postoperative recovery and the like compared with traditional surgical treatment. The process of vascular interventional surgery usually includes puncturing a superficial artery or superficial vein of a human body using a puncture needle, then using a medical guide wire to enter the human body vascular system through the puncture point incision, and using the medical guide wire to guide other instruments to enter the blood vessel and reach the lesion. Therefore, the medical guide wire is crucial for vascular interventional surgery, and whether the medical guide wire can reach and pass through the lesion position greatly affects the success of the surgery.

[0003] The medical guide wire in the prior art usually includes a mandrel and a hypotube sleeved on a distal end portion of the mandrel, and the flexibility and torque control effect of the medical guide wire are realized through a cut groove on the hypotube. However, the change of flexibility and support performance of these medical guide wires does not conform to the change of the curved segment of the blood vessel, so that the distal end of the medical guide wire is difficult to reach the lesion position. SUMMARY

[0004] The present application aims to provide an interventional device, the change of flexibility of which can conform to the change of the curved segment of the blood vessel and smoothly reach the lesion position.

[0005] To achieve the above-mentioned purpose, the present application provides an interventional device for inserting into a target lumen, the target lumen comprising a plurality of predetermined regions, the predetermined regions being at least partially curved; the interventional device comprising a tubular member having a first inner cavity, a plurality of through grooves being arranged on the side wall of the tubular member and communicating with the first inner cavity, so that a plurality of circumferentially extending rings and a plurality of axially extending beams connecting the rings are formed on the tubular member;

[0006] Except for one ring located at a designated end of the tubular member, the other part of the tubular member is divided into a plurality of repeating units, each of the repeating units comprising at least one ring and the beam connected to the ring and extending towards the designated end; one of the two adjacent repeating units is rotationally offset with respect to the other, so that the plurality of repeating units are spirally arranged around the axis of the tubular member; the designated end is a distal end or a proximal end;

[0007] The tubular member comprises a plurality of sub-segments, and one of the sub-segments is arranged in one of the predetermined regions; the length L of the repeating unit on any one of the sub-segments, the angle a of the rotational offset between two adjacent repeating units on the sub-segment, and the minimum curvature K of the predetermined region corresponding to the sub-segment satisfy the following relationship: K > 0.

[0008] Optionally, the length of any one of the sub-segments is greater than the length of the predetermined region corresponding to the sub-segment.

[0009] Optionally, the pitch of the helical structure on any one of the sub-segments is greater than or equal to the length of the predetermined region corresponding to the sub-segment.

[0010] Optionally, all the beams are arranged around the axis of the tubular member and form at least one helical structure; the repeating unit comprises at least one ring; when the repeating unit comprises more than two rings, all the beams in the repeating unit are divided into a plurality of beam groups along the circumferential direction of the tubular member, and the number of beams in each beam group is equal to the number of rings in the repeating unit; all the beams in the same beam group are arranged in sequence along the axial direction and are located on different helical structures, and at least part of the beams in the same beam group are aligned in the circumferential direction, or all the beams in the same beam group are staggered in the circumferential direction.

[0011] Optionally, the flexibility of the tubular member increases in the direction from the proximal end to the distal end.

[0012] Optionally, the interventional device further comprises a mandrel, the mandrel comprises a first segment and a second segment connected to the distal end of the first segment, the outer diameter of the second segment is less than or equal to the minimum outer diameter of the first segment, and the second segment is arranged in the first inner cavity of the tubular member and connected with the tubular member; the flexibility of the interventional device increases in the direction from the proximal end to the distal end.

[0013] Optionally, the mandrel has a second inner cavity extending through the axial direction thereof.

[0014] Optionally, the cross section of the second segment is circular; or, the cross section of the second segment is flat; or, the cross section of the proximal end portion of the second segment is circular, and the cross section of the distal end portion of the second segment is flat; the flat shape comprises any one of an oval, an ellipse or a rectangle.

[0015] Optionally, the interventional device further comprises a visualization element for displaying the position of the tubular member.

[0016] Optionally, the developing element is arranged in the first inner cavity and sleeved on the mandrel.

[0017] Optionally, the interventional device further comprises a filling element filled in the first inner cavity.

[0018] Optionally, the interventional device further comprises atraumatic joints arranged at the distal end of the interventional device and connecting the distal end of the tubular member with the distal end of the mandrel.

[0019] Compared with the prior art, the interventional device has the following advantages:

[0020] The aforementioned interventional device is used for inserting into a target lumen, the target lumen comprising a plurality of predetermined regions, the predetermined regions being at least partially curved; the target lumen comprising the interventional device comprising a tubular member having a first inner cavity, a plurality of through grooves being arranged on the side wall of the tubular member and communicating with the first inner cavity, and a plurality of circumferentially extending rings and a plurality of axially extending beams connecting the rings being formed on the tubular member; except for one ring located at a designated end of the tubular member, the other part of the tubular member is divided into a plurality of repeating units, each of the repeating units comprising at least one ring and the beam connected to the ring and extending towards the designated end; one of the two adjacent repeating units is rotationally offset with respect to the other, so that the plurality of repeating units are arranged in a helix around the axis of the tubular member; the designated end is a distal end or a proximal end; the tubular member comprises a plurality of sub-segments, and one of the sub-segments is used for being arranged in one of the predetermined regions; the length L of the repeating units located on any one of the sub-segments, the angle a of the rotational offset between the two adjacent repeating units located on the sub-segment, and the minimum curvature K of the predetermined region corresponding to the sub-segment satisfy the following relationship: K>0. In this way, the flexibility of any one of the sub-segments of the tubular member can be adapted to the curvature change of the predetermined region corresponding to the sub-segment, so that the part of the interventional device corresponding to the sub-segment matches the curvature change of the predetermined region, which is beneficial to pushing the interventional device to the target lumen and making the distal end of the interventional device reach the target position in the target lumen.

[0021] Further, the length of any one of the sub-segments is greater than the length of the predetermined region corresponding to the sub-segment, and preferably the pitch of the helical structure on any one of the sub-segments is greater than or equal to the length of the predetermined region corresponding to the sub-segment, so as to ensure that the distal end of the interventional device reaches the target position of the target lumen. BRIEF DESCRIPTION OF DRAWINGS

[0022] The accompanying drawings are used to better understand the present application and do not constitute undue limitations on the present application.

[0023] Figure 1 is a structural schematic diagram of a medical guide wire provided by the present application according to an embodiment.

[0024] Figure 2 is a structural schematic diagram of a mandrel of a medical guide wire provided by the present application according to an embodiment.

[0025] Figure 3 is a partial sectional view of a medical guide wire provided by the present application according to an embodiment.

[0026] Figure 4a is a structural schematic diagram of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which the planar unfolded shape of the through slot is a right-angled rectangle.

[0027] Figure 4b is a structural schematic diagram of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which the planar unfolded shape of the through slot is a rounded rectangle.

[0028] Figure 5a is a radial sectional view of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which two adjacent rings are connected by one beam.

[0029] Figure 5b is a radial sectional view of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which two adjacent rings are connected by two beams.

[0030] Figure 5c is a radial sectional view of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which two adjacent rings are connected by three beams.

[0031] Figure 6a is a partial enlarged schematic diagram of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which each repeating unit includes one ring.

[0032] Figure 6b is a partial enlarged schematic diagram of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which each repeating unit includes two rings, and two beams in the same beam group are aligned in the circumferential direction of the tubular component.

[0033] Figure 6c is a partial enlarged schematic diagram of a tubular component of a medical guide wire provided by the present application according to an embodiment, in which each repeating unit includes two rings, and two beams in the same beam group are staggered in the circumferential direction of the tubular component.

[0034] Figure 7is a use scenario diagram of the medical guide wire provided by the embodiment of the present application.

[0035] Figure 8 is a local diagram of a human body blood vessel, and the dashed line is the boundary line of the first region, the second region and the third region.

[0036] Figure 9a is Figure 2 is a radial sectional view of the second segment of the mandrel of the medical guide wire provided by the embodiment of the present application, and the cross section of the mandrel is circular.

[0037] Figure 9b is Figure 2 is a radial sectional view of the second segment of the mandrel of the medical guide wire provided by the embodiment of the present application, and the cross section of the mandrel is a waist circle.

[0038] Figure 10 is an axial sectional view of the mandrel of the medical guide wire provided by the embodiment of the present application.

[0039] Figure 11a is a local sectional view of the medical guide wire provided by the embodiment of the present application, and the diagram shows a developing element, and the developing element comprises one developing spring.

[0040] Figure 11b is a local sectional view of the medical guide wire provided by the embodiment of the present application, and the diagram shows a developing element, and the developing element comprises two developing springs.

[0041] Figure 11c is a local sectional view of the medical guide wire provided by the embodiment of the present application, and the diagram shows a developing element, and the developing element comprises several developing rings.

[0042] In the drawings: 10 - medical guide wire; 100 - tubular component, 101 - first inner cavity, 102 - through slot, 103 - ring, 104 - beam, 104a - first beam, 104b - second beam, 110 - repeating unit, 120 - beam group, 111a - first sub-segment, 111b - second sub-segment, 111c - third sub-segment, 111d - fourth sub-segment, 111e - fifth sub-segment, 200 - mandrel, 210 - first segment, 211 - proximal segment, 212 - first transition section, 213 - first intermediate segment, 214 - second transition section, 215 - second intermediate segment, 216 - third transition section, 220 - second segment, 201 - second inner cavity; 300 - joint; 400 - developing element; 21 - first region, 22 - second region, 23 - third region. DETAILED DESCRIPTION

[0043] The present application is herein described, by way of example only, with the comprehension that the advantages and utility thereof are apparent and that modifications, of form, arrangement, proportions, and details of the herein described embodiments can be made by those skilled in the art without departing from the spirit and essential characteristics of the application. It is to be expressly understood, therefore, that the drawings are for the purpose of illustration only and the scope of the application is not to be limited as to the precise details shown. The description of the embodiments of the application herein made is not intended to limit the scope of the application, but rather, these embodiments are intended to serve as illustrative examples of the application.

[0044] In addition, each of the embodiments described below has one or more technical features, but this does not mean that all technical features in any embodiment must be implemented at the same time, or that only one or all technical features in different embodiments can be implemented separately. In other words, under the premise of implementation, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present application, and according to design specifications or implementation needs, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present application.

[0045] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise, and the terms "mounting," "connected," and "connection" should be interpreted broadly, for example, as fixedly connected, removably connected, or integrally connected. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium. It can be the internal communication of two elements or the interaction relationship between two elements. Those skilled in the art can understand the specific meaning of the above terms in the present application according to the specific circumstances.

[0046] In this paper, the terms "proximal" and "distal" are the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of the doctor using the medical device, although "proximal" and "distal" are not restrictive, but "proximal" generally refers to the end of the medical device close to the doctor during normal operation, and "distal" generally refers to the end first entering the patient's body.

[0047] The core idea of the present application is to provide an intervention device for insertion into a target lumen, and the distal end of the intervention device is used to reach a target position in the target lumen. The present application reasonably sets the structure of the intervention device, so that the intervention device has the effects of flexibility and twist control, and the flexibility and support of the intervention device can also adapt to the curvature change of the curved section of the target lumen, thereby ensuring that the distal end of the intervention device can reach the target position.

[0048] To achieve the above-mentioned purpose, the intervention device comprises a tubular member having a first inner cavity, a plurality of through grooves are arranged on the side wall of the tubular member and communicate with the first inner cavity, so that a plurality of circumferentially extending rings and a plurality of beams connecting the rings are formed on the tubular member. Except for one ring located at a specified end of the tubular member, the other part of the tubular member is divided into a plurality of repeating units, each of the repeating units comprises at least one ring and the beam connected to the ring and extending to the specified end; one of the two adjacent repeating units is rotationally offset with respect to the other, so that a plurality of repeating units are arranged in a spiral around the axis of the tubular member; the specified end is the distal end or the proximal end; the tubular member comprises a plurality of sub-segments, one of the sub-segments is arranged in a predetermined area of the target lumen, and the predetermined area is at least partially curved. The length L of the repeating unit located on any one of the sub-segments, the angle a of the rotational offset between the two adjacent repeating units located in the sub-segment, and the minimum curvature K of the predetermined area corresponding to the sub-segment satisfy the following relationship: K>0.

[0049] In some embodiments of the present application, the intervention device can be a medical catheter. In other embodiments of the present application, the intervention device can be a medical guide wire.

[0050] In order to make the purpose, advantages and characteristics of the present application more clear, the following will further describe the present application in detail by taking the intervention device as a medical guide wire and combining with the drawings. It should be noted that the drawings are very simplified and use non-precise proportions, only for the purpose of facilitating and clearly assisting the description of the embodiments of the present application. The same or similar reference signs in the drawings represent the same or similar parts.

[0051] As Figures 1 to 3As shown, the medical guide wire 10 comprises a tubular member 100 and a mandrel 200. The tubular member 100 has a first inner cavity 101. The mandrel 200 comprises a first segment 210 and a second segment 220 connected to a distal end of the first segment 210, an outer diameter of the second segment 220 is less than or equal to a minimum outer diameter of the first segment 210, and the second segment 220 is arranged in the first inner cavity 101 of the tubular member 100 and connected with the tubular member 100. The softness of the medical guide wire 10 increases from proximal end to distal end.

[0052] As shown in Figure 4a and Figure 4b As shown, the raw material of the tubular member 100 is a cylindrical tube, and a plurality of through grooves 102 are cut on the side wall of the tube by means of laser cutting or mechanical cutting to communicate with the first inner cavity 101, so that a plurality of circumferentially extending rings 103 and a plurality of beams 104 connecting adjacent two rings 103 are formed on the tubular member 100. The planar developed shape of the through groove 102 can be a right-angled rectangle (as shown in Figure 4a ), a rounded rectangle (as shown in Figure 4b ), or a waist-round shape. In addition, at least one through groove 101 can be cut on the same circumference of the tubular member 100, specifically one (as shown in Figure 5a ), two (as shown in Figure 5b ), three (as shown in Figure 5c ), or more, which is not limited by the embodiments of the present application.

[0053] Optionally, please refer back to Figure 1 , and combine with Figures 6a to 6c , except for one ring 103 at the end of the designated end of the tubular member 100, the other parts of the tubular member 100 are divided into a plurality of repeating units 110. The designated end can be a distal end or a proximal end, and the distal end is taken as the designated end for illustration in this paper. Each repeating unit 110 comprises at least one ring 103 and the beam 104 connected to the ring 103 and extending distally. One of the adjacent two repeating units 110 is rotationally offset with respect to the other, so that a plurality of repeating units 110 are arranged in a spiral around the axis of the tubular member 100, and in turn, all the beams 104 of the tubular member 100 are arranged around the axis of the tubular member 100 and form at least one spiral structure.

[0054] For example, as shown in Figure 5aAs shown, a through groove 101 is formed on the same circumference of the tubular component 100, such that adjacent rings 103 are connected by a beam 104. Thus, when each repeating unit 110 includes a ring 103, each repeating unit 110 also includes a beam 104. Starting from the second repeating unit 110, along the proximal-to-distal direction, one repeating unit 110 is rotated relative to the previous repeating unit 110 by an angle α, such that all the beams 104 form a spiral structure (not shown), and one of two adjacent beams 104 is also rotated relative to the other by an angle α. Here, the previous repeating unit 110 refers to the one closer to the proximal end of two adjacent repeating units 110.

[0055] Or, such as Figure 5b As shown, two spaced-apart through grooves 101 are formed on the same circumference of the tubular component 100, such that adjacent rings 103 are connected by two beams 104, preferably the two beams 104 are arranged at equal intervals along the circumference of the tubular component 100. Figure 6a As shown, when each repeating unit 110 includes one ring 103, each repeating unit 110 also includes two beams 104. Starting from the second repeating unit 110, along the proximal-to-distal direction, each repeating unit 110 is rotated relative to the previous repeating unit 110 by an angle α, such that all the beams 104 form a first helical structure S1 and a second helical structure S2 that are parallel to each other, and the angle of rotational offset between two adjacent beams 104 on the same helical structure is also α.

[0056] Or, as Figure 6b and Figure 6cAs shown, each repeating unit 110 includes two or more rings 103, and all beams 104 in the same repeating unit 110 are divided into several beam groups 120 along the circumference of the tubular component 100. The number of beams 104 in each beam group 120 is equal to the number of rings 103 in one repeating unit 110. All beams 104 in the same beam group 120 are arranged sequentially along the axial direction, and at least some beams 104 in the same beam group 120 are aligned in the circumferential direction, or all beams 104 in the same beam group 120 are staggered in the circumferential direction. Since the multiple repeating units 110 are spirally arranged, the corresponding beam groups 120 of different repeating units 110 are spirally arranged, and all beams 104 in the same beam group 120 are located on different spiral structures. Thus, the number of spiral structures formed by all beams 104 is the product of the number of beam groups 120 and the number of beams 104 in each beam group 120. Specifically, taking the example of two through grooves 101 formed on the same circumference of the tubular component 100, please refer to [reference needed]. Figure 6b and Figure 6c When the repeating unit 110 includes two rings 103, and each repeating unit 110 includes three beam groups 120 (i.e., three spaced-apart through slots 102 are formed on the same circumference of the tubular component 100), each beam group 120 includes two beams 104 arranged axially, namely a first beam 104a and a second beam 104b. The first beam 104a and the second beam 104b are aligned circumferentially with respect to the tubular component 100 (e.g., ...). Figure 6b (as shown), or the first beam 104a and the second beam 104b are offset circumferentially from the tubular member 100 (as shown). Figure 6c (As shown). All of the beams 104 form mutually parallel first helical structures S1, second helical structure S2, third helical structure S3, fourth helical structure S4, fifth helical structure (not shown in the figure) and sixth helical structure (not shown in the figure).

[0057] Of course, the repeating unit 110 may also include more rings 103, such as three. Correspondingly, all the beams 104 may form more helical structures. For example, when two through slots 101 are formed on the same circumference of the tubular component 100 and the repeating unit 110 includes three rings 103, all the beams 104 may form six helical structures. When three through slots 101 are formed on the same circumference of the tubular component 100 and the repeating unit 110 includes three rings 103, all the beams 104 may form nine helical structures.

[0058] like Figure 7 As shown, the medical guidewire 10 is used for insertion into a target lumen, which may be a blood vessel. The tubular component 100 is configured such that its flexibility increases from proximal to distal, facilitating insertion. Generally, when the length L of the repeating unit 110 remains constant, the greater the ratio of the width D1 of the through groove 102 to the width D2 of the beam 104, the greater the flexibility of the tubular component 100. Furthermore, when the ratio of the width D1 of the through groove 102 to the width D2 of the beam 104 remains constant, the smaller the length L of the repeating unit 110, the greater the flexibility of the tubular component 100. Therefore, those skilled in the art can adjust the flexibility of the tubular component 100 at any position by changing at least one of the ratio of the width D1 of the through groove 102 to the width D2 of the beam 104 and changing the length L of the repeating unit 110. The width D1 of the through groove 102 refers to the circumferential dimension of the through groove 102 in the tubular component 100, and the width D2 of the beam 104 refers to the circumferential dimension of the beam 104 in the tubular component 100. The length L of the repeating unit 100 refers to the axial dimension of the repeating unit 100 in the tubular component 100.

[0059] Furthermore, the target lumen includes several predetermined regions, and the predetermined regions are at least partially curved. Correspondingly, in this embodiment of the invention, the tubular component 100 includes several sub-segments, and when the medical guidewire 10 is inserted into the target lumen, one of the sub-segments passes through a corresponding predetermined region. The length L of the repeating unit 100 located on any of the sub-segments, the rotational offset angle α between two adjacent repeating units 100 located on that sub-segment (i.e., the rotational offset angle between two adjacent repeating units 110), and the minimum curvature K of the predetermined region corresponding to that sub-segment satisfy the following relationship (1): It is understandable that K > 0. Additionally, it should be noted that in different sub-segments of the tubular component 100, the rotational offset angle α of two adjacent repeating units 110 (or two adjacent beams 104 in the same helical structure) may be the same or different, depending on the specific requirements.

[0060] For example, the distal end of the medical guidewire 10 can enter the intracranial artery through a puncture site on the carotid artery. Figure 8As shown, starting from a designated location on the carotid artery, the blood vessel is divided into three sequentially connected regions: a first region 21, a second region 22, and a third region 23, based on its morphology. The first region 21 can be the distal end of the carotid artery, while the second and third regions 22 are located intracranial. Each of the three regions includes a tortuous portion, thus constituting the predetermined region. Please refer back to the reference. Figure 1 The tubular component 100 includes a first sub-segment 111a, a second sub-segment 111b, and a third sub-segment 111c, which are connected sequentially from proximal to distal. The first sub-segment 111a is inserted into the first region 21, the second sub-segment 111b into the second region 22, and the third sub-segment 111c into the third region 23. The cutting parameters of the first sub-segment 111a, the second sub-segment 111b, and the third sub-segment 111c can be determined according to the relationship (1). Specifically, the length of the repeating unit 110 located at the first sub-segment 111a, the rotational offset angle between two adjacent repeating units 110 located at the first sub-segment 111a, and the minimum curvature of the first region 21 conform to the relationship (1). The length of the repeating unit located at the second sub-segment 111b, the rotational offset angle between two adjacent repeating units 110 located at the second sub-segment 111b, and the minimum curvature of the second region 22 conform to the relationship (1). Similarly, the length of the repeating unit 110 located at the third sub-segment 111c, the rotational offset angle between two adjacent repeating units 110 located at the third sub-segment 111c, and the minimum curvature of the third region 23 conform to the relationship (1). That is, in this embodiment of the invention, the cutting parameters of at least a portion of the segments of the tubular component 100 can be reasonably set according to the curvature of each region of the target lumen, so that the flexibility of each sub-segment of the tubular component 100 adapts to the curvature change of the corresponding predetermined region, thereby matching the flexibility of the medical guidewire 10 with the curvature change of each predetermined region of the target lumen. In this way, the flexibility of the medical guide wire 10 is within a suitable range, that is, the medical guide wire 10 is neither too soft nor too hard, and can maintain good support performance while controlling cutting costs.

[0061] In addition, the tubular component 100 also includes a fourth sub-segment 111d and a fifth sub-segment 111e, wherein the fifth sub-segment 111e is connected to the proximal end of the first sub-segment 111a, and the fourth sub-segment 111d is connected to the proximal end of the fifth sub-segment 111e. The fourth sub-segment 111d and the fifth sub-segment 111e are used to pass through the straight segment (not shown in the figure) of the carotid artery. Therefore, the flexibility of the fourth sub-segment 111d and the fifth sub-segment 111e only needs to meet the requirement of increasing in the direction from the proximal end to the distal end.

[0062] To ensure that the distal end of the medical guidewire 10 reaches the predetermined position within the target lumen, in this embodiment, it is further preferred that the length of the sub-segment is greater than the length of the predetermined region corresponding to the sub-segment, and that the pitch of the helical structure on the sub-segment is greater than or equal to the length of the predetermined region corresponding to the sub-segment. For Figure 8 For the illustrated blood vessel, the length of the first sub-segment 111a is greater than the length of the first region 21, and the pitch of the helical structure on the first sub-segment 111a is greater than the length of the first region 21; the length of the second sub-segment 111b is greater than the length of the second region 22, and the pitch of the helical structure on the second sub-segment 111b is greater than the length of the second region 22; the length of the third sub-segment 111c is greater than the length of the third region 23, and the pitch of the helical structure on the third sub-segment 111c is greater than the length of the third region 23. It can be understood that the pitch refers to the distance traveled by the helical structure in the axial direction of the tubular component 100 when the helical structure rotates one revolution; in other words, the pitch is the distance between the two ends of one helical loop of the helical structure in the axial direction of the tubular component 100. The length of the first region 21 refers to the size of the region when the first region 21 of the blood vessel is stretched into a linear shape. Similarly, the length of the second region 22 refers to the size of the region when the second region 22 of the blood vessel is stretched into a linear shape. The length of the third region 23 refers to the size of the region when the third region 23 of the blood vessel is stretched into a linear shape.

[0063] Still with Figure 8 Taking the blood vessel shown as an example, the lengths and minimum curvatures of the first region 21, the second region 22, and the third region 23 are obtained from clinical anatomical data, and the relevant parameters of the first sub-segment 111a, the second sub-segment 111b, and the third sub-segment 111c of the tubular component 100 are obtained by combining the relation (1) as shown in Table 1. The relevant parameters include the length L of the repeating unit 100 located in each sub-segment, and the rotational offset angle α between two adjacent beams 104 on the same helical structure.

[0064] Table 1

[0065]

[0066] Please return to the reference. Figure 2 The outer diameter of the mandrel 200 decreases from the proximal end to the distal end, thereby increasing the flexibility of the medical guidewire 10 from the proximal end to the distal end. In an optional implementation, the first segment 210 may include a proximal segment 211, a first transition segment 212, a first intermediate segment 213, a second transition segment 214, a second intermediate segment 215, and a third transition segment 216 connected sequentially from the proximal end to the distal end. The first segment 211 has a uniform outer diameter. The first transition segment 212 is a tapered segment whose cross-section decreases from the proximal end to the distal end, and the maximum outer diameter of the first transition segment 212 is equal to the outer diameter of the proximal segment 211. The first intermediate segment 213 has a uniform outer diameter, and the outer diameter of the first intermediate segment 213 is equal to the minimum outer diameter of the first transition segment 212. The second transition segment 214 is a tapered segment whose cross-section decreases from the proximal end to the distal end, and the maximum outer diameter of the second transition segment 214 is equal to the outer diameter of the first intermediate segment 213. The second intermediate segment 215 has a uniform outer diameter, which is equal to the minimum outer diameter of the second transition segment 214. The third transition segment 216 is also a tapered segment, with its cross-section decreasing from the proximal end to the distal end, and the maximum outer diameter of the third transition segment 216 is equal to the outer diameter of the second intermediate segment 215. The second segment 220 of the mandrel 200 may have a uniform outer diameter, which is equal to the minimum outer diameter of the third transition segment 216. It should be noted that in some embodiments, the cross-section of the second segment 220 at any position is circular (e.g., ...). Figure 9a As shown), in some other implementations, the cross-section at at least a portion of the second segment 220 is flat, the flat shape including an oval shape (e.g., ...). Figure 9b As shown), ellipse or rectangle, etc. In this case, the outer diameter of the second segment 220 refers to the diameter of the circumcircle of the cross-section at any position of the second segment 220.

[0067] Preferably, the cross-section of at least a portion of the mandrel 200 is flat, specifically, the cross-section of any position of the second segment 220 is flat. Alternatively, the cross-section of the proximal portion of the second segment 220 is circular, and the cross-section of the distal portion of the second segment 220 is flat. This improves the malleability of the distal end of the mandrel 200, thereby enhancing the malleability of the distal end of the medical guidewire 10, allowing the operator to easily bend the distal end of the medical guidewire 10 during actual use.

[0068] In addition, such as Figure 10 As shown, the mandrel 200 may also have a second inner cavity 201 extending axially through, which can be used to transfer other components to the target location.

[0069] Furthermore, the distal end of the second segment 220 of the mandrel 200 can be connected via a non-invasive joint 300 (e.g., Figure 1 , Figure 3 , Figure 11a , Figure 11b and Figure 11c (As shown) is connected to the distal end of the tubular component 100. The joint 300 can be formed by dispensing or hot melting, or by welding.

[0070] Furthermore, such as Figures 11a to 11c As shown, the medical guidewire 10 further includes a radiopaque element 400, which is used to display the position of the tubular component 100. The radiopaque element 400 can be disposed within the first inner cavity 101 and mounted on the second segment 220 of the mandrel 200. The radiopaque element 400 can specifically be a radiopaque spring or a radiopaque ring, and the number of radiopaque elements 400 is not limited in this embodiment of the invention; it can be one (as shown in 11a) or multiple (as shown in 11a). Figure 11b and Figure 11c As shown, when there are multiple developing elements 400, the multiple developing elements 400 can be arranged continuously or spaced apart along the axial direction of the tubular component 100.

[0071] Preferably, the medical guidewire 10 may further include a filling element that fills the first lumen to further improve the malleability of the distal portion of the medical guidewire 10 (i.e., the region where the tubular component 100 is located). Optionally, the imaging element 400 constitutes at least a portion of the filling element.

[0072] In the interventional device provided by the embodiments of the present invention, the cutting parameters of the tubular component of the interventional device that match the predetermined region are determined by the length and minimum curvature of the predetermined region of the target lumen, thereby improving the flexibility of the interventional device and the matching degree of the target lumen, which in turn facilitates the insertion of the interventional device into the target lumen and allows the distal end of the interventional device to be smoothly pushed into the target position within the target lumen.

[0073] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. An interventional device for insertion into a target lumen, the target lumen comprising a plurality of predetermined regions, the predetermined regions being at least partially curved; characterized in that, The interventional device includes a tubular component having a first inner cavity, and a plurality of through grooves communicating with the first inner cavity are provided on the side wall of the tubular component, so that a plurality of circumferentially extending rings and a plurality of beams connecting the rings are formed on the tubular component. Except for one ring located at a designated end of the tubular component, the other portions of the tubular component are divided into a plurality of repeating units, each repeating unit including at least one ring and a beam connected to the ring and extending toward the designated end; one of two adjacent repeating units is rotated relative to the other such that the plurality of repeating units are spirally arranged about the axis of the tubular component; the designated end is either a distal end or a proximal end; The tubular component comprises a plurality of sub-segments, and one of the sub-segments is used to pass through a predetermined region; the length L of the repeating unit located on any one of the sub-segments, and the rotational offset angle between two adjacent repeating units located on that sub-segment. and the minimum curvature of the predetermined region corresponding to the sub-segment. The following relationship must be satisfied: , .

2. The interventional device according to claim 1, characterized in that, The length of any of the sub-segments is greater than the length of the predetermined region corresponding to that sub-segment.

3. The interventional device according to claim 1, characterized in that, All the beams are arranged around the axis of the tubular component and form at least one helical structure, wherein the pitch of the helical structure on any of the sub-segments is greater than or equal to the length of the predetermined region corresponding to that sub-segment.

4. The interventional device according to claim 1, characterized in that, All the beams are arranged around the axis of the tubular component and form at least one helical structure; the repeating unit includes at least one ring; when the repeating unit includes two or more rings, all the beams in the repeating unit are divided into several beam groups along the circumference of the tubular component, and the number of beams in each beam group is equal to the number of rings in the repeating unit; all the beams in the same beam group are arranged sequentially along the axial direction and located on different helical structures, and at least some of the beams in the same beam group are aligned in the circumferential direction, or all the beams in the same beam group are staggered in the circumferential direction.

5. The interventional device according to claim 1, characterized in that, The flexibility of the tubular component increases from the proximal end to the distal end.

6. The interventional device according to any one of claims 1-5, characterized in that, The interventional device further includes a mandrel, which includes a first segment and a second segment connected to the distal end of the first segment. The outer diameter of the second segment is less than or equal to the minimum outer diameter of the first segment, and the second segment is disposed in the first inner cavity of the tubular component and connected to the tubular component. The flexibility of the interventional device increases from the proximal end to the distal end.

7. The interventional device according to claim 6, characterized in that, The mandrel has a second inner cavity extending through it along its axial direction.

8. The interventional device according to claim 6, characterized in that, The cross-section of the second segment is circular; or, the cross-section of the second segment is flat; or, the cross-section of the proximal portion of the second segment is circular, and the cross-section of the distal portion of the second segment is flat; the flat shape includes any one of oval, elliptical, or rectangular.

9. The interventional device according to claim 6, characterized in that, The interventional device also includes a imaging element for displaying the position of the tubular component.

10. The interventional device according to claim 9, characterized in that, The developing element is disposed in the first inner cavity and mounted on the mandrel.

11. The interventional device according to claim 6, characterized in that, The interventional device further includes a filling element that fills the first cavity.

12. The interventional device according to claim 6, characterized in that, The interventional device further includes a non-invasive joint disposed at the distal end of the interventional device, which connects the distal end of the tubular component to the distal end of the mandrel.

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