WO2023125027A1 - 一种介入装置 - Google Patents

一种介入装置 Download PDF

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Publication number
WO2023125027A1
WO2023125027A1 PCT/CN2022/139157 CN2022139157W WO2023125027A1 WO 2023125027 A1 WO2023125027 A1 WO 2023125027A1 CN 2022139157 W CN2022139157 W CN 2022139157W WO 2023125027 A1 WO2023125027 A1 WO 2023125027A1
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WO
WIPO (PCT)
Prior art keywords
segment
interventional device
sub
beams
tubular member
Prior art date
Application number
PCT/CN2022/139157
Other languages
English (en)
French (fr)
Inventor
周炯
周成全
Original Assignee
神途医疗科技(上海)有限公司
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Publication of WO2023125027A1 publication Critical patent/WO2023125027A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09166—Guide wires having radio-opaque features

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an interventional device.
  • vascular interventional surgery is an important method for the treatment of cardiovascular and cerebrovascular diseases. Compared with traditional surgical treatment, it has the advantages of less trauma and faster postoperative recovery.
  • the process of vascular intervention usually includes using a puncture needle to puncture the superficial artery or superficial vein of the human body, then using a medical guide wire to enter the human vascular system through the incision at the puncture point, and using the medical guide wire to guide other instruments into the blood vessel and reach the lesion. Therefore, the medical guide wire is very important for vascular interventional surgery. Whether the medical guide wire can reach and pass through the lesion position greatly affects the success of the operation.
  • the medical guide wire in the prior art usually includes a mandrel and a hypotube sleeved on the distal part of the mandrel, and the flexibility and twist control of the medical guide wire can be achieved through the slots on the hypotube. Changes in the flexibility and support performance of these medical guide wires do not conform to changes in the curved section of the blood vessel, making it difficult for the distal end of the medical guide wire to reach the lesion.
  • the purpose of the present invention is to provide an interventional device, the change of its flexibility can follow the change of the curved section of the blood vessel, and can reach the lesion position smoothly.
  • the present invention provides an interventional device for inserting into a target lumen, the target lumen includes several predetermined areas, and the predetermined areas are at least partially curved; the interventional device includes a first lumen A tubular component, the side wall of the tubular component is provided with a plurality of through grooves communicating with the first inner cavity, so that a plurality of circumferentially extending rings and a plurality of axially extending rings are formed on the tubular component. beams extending and connecting the rings;
  • the rest of said tubular member is divided into a plurality of repeating units, each of said repeating units comprising at least one of said rings and connected to said rings, and the beam extending toward the specified end; one of the two adjacent repeating units is rotationally offset relative to the other, so that a plurality of the repeating units are helically arranged around the axis of the tubular member;
  • the specified end is a distal end or a proximal end;
  • the tubular component includes several sub-sections, and one of the sub-sections is used to pass through one of the predetermined regions; the length L of the repeating unit located on any one of the sub-sections is located in the sub-section.
  • the angle a of the rotation offset between the segment and two adjacent repeating units, and the minimum curvature K of the predetermined area corresponding to the sub-segment satisfy the following relationship: K>0.
  • the length of any one of the sub-segments is greater than the length of the predetermined region corresponding to the sub-segment.
  • 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.
  • all the beams are arranged around the axis of the tubular part and form at least one helical structure; the repeating unit includes at least one ring; when the repeating unit includes more than two rings , all the beams in the repeating unit are divided into several beam groups along the circumferential direction of the tubular part, and the number of beams included in each beam group is the same as the number of beams included in the repeating unit The number of rings is equal; all the beams in the same beam group are arranged in sequence along the axial direction, and are located on different spiral structures, and at least some of the beams in the same beam group are aligned in the circumferential direction, or the same beam group All said beams in said beam group are circumferentially staggered.
  • the flexibility of the tubular member increases in a proximal to distal direction.
  • the interventional device further includes a mandrel, the mandrel 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 lumen of the tubular member and connected to the tubular member; the softness of the interventional device Increases in proximal to distal direction.
  • the mandrel 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 lumen of the tubular member and connected to the tubular member; the softness of the interventional device Increases in proximal to distal direction.
  • the mandrel has a second lumen extending through it axially.
  • the cross section of the second section is circular; or, the cross section of the second section is flat; or, the cross section of the proximal part of the second section is circular , the cross-section of the distal end portion of the second segment is a flat shape; the flat shape includes any one of waist circle, ellipse or rectangle.
  • the interventional device further includes a developing element for displaying the position of the tubular component.
  • the developing element is disposed in the first inner cavity and sleeved on the mandrel.
  • the interventional device further includes a filling element, and the filling element is filled in the first lumen.
  • the interventional device further includes an atraumatic joint, which is disposed at the distal end of the interventional device and connects the distal end of the tubular member to the distal end of the mandrel.
  • the interventional device of the present invention has the following advantages:
  • the aforementioned interventional device is used for inserting into a target lumen, the target lumen includes several predetermined areas, and the predetermined areas are at least partially curved; the target lumen includes the interventional device including a tubular member having a first lumen, The side wall of the tubular member is provided with a plurality of through grooves communicating with the first inner cavity, and the tubular member is formed with a plurality of circumferentially extending rings and a plurality of axially extending and connected a beam of said rings; except for one said ring at a given end of said tubular member, the remainder of said tubular member is divided into a plurality of repeating units, each of said repeating units comprising at least one of said rings and connecting said beam on said ring and extending toward said designated end; one of adjacent two said repeating units is rotationally offset relative to the other such that a plurality of said repeating units surround said tubular member
  • the axis is helically arranged; the specified end is the distal end or the proxi
  • Such setting can make the softness of any sub-section of the tubular member adapt to the curvature change of the predetermined area corresponding to the sub-section, so that the part of the interventional device corresponding to the sub-section is in line with the
  • the matching of the curvature changes of the predetermined area facilitates pushing the interventional device to the target lumen, and makes the distal end of the interventional device reach the target position in the target lumen.
  • 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.
  • the length of the predetermined area corresponding to the sub-segments ensures that the distal end of the interventional device reaches the target position of the target lumen.
  • Fig. 1 is a schematic structural view of a medical guide wire provided by the present invention according to an embodiment.
  • Fig. 2 is a schematic structural view of a mandrel of a medical guide wire according to an embodiment of the present invention.
  • Fig. 3 is a partial cross-sectional view of a medical guide wire provided according to an embodiment of the present invention.
  • Fig. 4a is a schematic structural view of the tubular part of the medical guide wire according to an embodiment of the present invention, in which the planar development shape of the through groove is a right-angled rectangle.
  • Fig. 4b is a schematic structural view of the tubular part of the medical guide wire provided according to an embodiment of the invention, in which the planar development shape of the through groove is a rounded rectangle.
  • Fig. 5a is a radial cross-sectional view of the tubular part of the medical guide wire according to an embodiment of the present invention, in which two adjacent rings are connected by a beam.
  • Fig. 5b is a radial cross-sectional view of the tubular part of the medical guide wire according to an embodiment of the present invention, in which two adjacent rings are connected by two beams.
  • Fig. 5c is a radial cross-sectional view of the tubular part of the medical guide wire according to an embodiment of the present invention, in which two adjacent rings are connected by three beams.
  • Fig. 6a is a partially enlarged schematic view of the tubular part of the medical guide wire according to an embodiment of the present invention, and each repeating unit in the figure includes a ring.
  • Fig. 6b is a partially enlarged schematic view of the tubular part of the medical guide wire according to an embodiment of the present invention, each repeating unit in the figure includes two rings, and the two beams in the same beam group are aligned in the circumferential direction of the tubular part .
  • Fig. 6c is a partially enlarged schematic view of the tubular part of the medical guide wire according to an embodiment of the present invention.
  • each repeating unit includes two rings, and the two beams in the same beam group are staggered in the circumferential direction of the tubular part.
  • Fig. 7 is a schematic diagram of the use scene of the medical guide wire provided by the embodiment of the present invention.
  • Fig. 8 is a partial schematic diagram of a human blood vessel, in which the dotted line is the boundary line between the first area, the second area and the third area.
  • Fig. 9a is a radial sectional view of the second segment of the mandrel of the medical guide wire provided in Fig. 2, in which the cross section of the mandrel is circular.
  • Fig. 9b is a radial sectional view of the second segment of the mandrel of the medical guide wire provided in Fig. 2, in which the cross section of the mandrel is waist-shaped.
  • Fig. 10 is an axial cross-sectional view of a mandrel of a medical guide wire according to an embodiment of the present invention.
  • Fig. 11a is a partial cross-sectional view of a medical guide wire according to an embodiment of the present invention, in which a developing element is shown, and the developing element includes a developing spring.
  • Fig. 11b is a partial cross-sectional view of a medical guide wire provided by an embodiment of the present invention, in which a developing element is shown, and the developing element includes two developing springs.
  • Fig. 11c is a partial cross-sectional view of a medical guide wire provided by an embodiment of the present invention, in which a developing element is shown, and the developing element includes several developing rings.
  • 10-medical guide wire 100-tubular component, 101-first lumen, 102-through groove, 103-ring, 104-beam, 104a-first beam, 104b-second beam, 110-repeat 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-core Shaft, 210-first segment, 211-proximal segment, 212-first transition segment, 213-first intermediate segment, 214-second transition segment, 215-second intermediate segment, 216-third Transition section, 220-second segment, 201-second inner cavity; 300-joint portion; 400-developing element; 21-first area, 22-second area, 23-third area.
  • each embodiment of the content described below has one or more technical features, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • proximal refers to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although “proximal”, “distal ” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the practitioner during normal operation, and “distal” generally refers to the end that enters the patient first.
  • the core idea of the present invention is to provide an interventional device for inserting into a target lumen, and the distal end of the interventional device is for reaching a target position in the target lumen.
  • the present invention rationally arranges the structure of the interventional device so that the compliance and support of the interventional device can conform to the requirements of the The change in curvature of the curved section of the target lumen ensures that the distal end of the interventional device can reach the target position.
  • the interventional device includes a tubular part with a first lumen, and a plurality of through grooves communicating with the first lumen are provided on the side wall of the tubular part, so that the tubular part A plurality of circumferentially extending rings and a plurality of beams connecting the rings are formed thereon.
  • the rest of said tubular member is divided into a plurality of repeating units, each of said repeating units comprising at least one of said rings and connected to said rings, and the beam extending toward the specified end; one of the two adjacent repeating units is rotationally offset relative to the other, so that a plurality of the repeating units are helically arranged around the axis of the tubular member;
  • the designated end is a distal end or a proximal end;
  • the tubular member includes several sub-sections, one of which is adapted to be threaded in a predetermined region of the target lumen, the predetermined region 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 rotation offset between two adjacent repeating units located in the sub-segment, and corresponding to the sub-segment The minimum curvature K of the predetermined area satisfies the following relationship: K>0.
  • the interventional device may be a medical catheter. In some other embodiments of the present invention, the intervention device may be a medical guide wire.
  • the medical guide wire 10 includes a tubular component 100 and a mandrel 200 .
  • the tubular part 100 has a first lumen 101 .
  • the mandrel 200 includes a first segment 210 and a second segment 220 connected to the distal end of the first segment 210, the outer diameter of the second segment 220 is smaller than or equal to the first segment 210 , and the second section 220 is disposed in the first lumen 101 of the tubular component 100 and connected with the tubular component 100 .
  • the softness of the medical guide wire 10 increases from the proximal end to the distal end.
  • the raw material of the tubular member 100 is a cylindrical tube, and a plurality of tubes are cut on the side wall of the tube by laser cutting or mechanical cutting to form multiple
  • the cavity 101 communicates with the through groove 102 , so that a plurality of rings 103 extending along the circumferential direction and a plurality of beams 104 connecting two adjacent rings 103 are formed on the tubular member 100 .
  • the planar development shape of the through groove 102 may be a right-angled rectangle (as shown in FIG. 4a ), or a rounded rectangle (as shown in FIG. 4b ), or a waist circle.
  • At least one through groove 102 can be cut and formed, specifically one (as shown in FIG. 5a ), two (as shown in FIG. 5b ), three (as shown in FIG. 5c), or more, which is not limited in this embodiment of the present invention.
  • each of the repeating units 110 includes at least one ring 103 and the beam 104 connected to the ring 103 and extending distally.
  • One of the two adjacent repeating units 110 is rotationally offset relative to the other, so that a plurality of repeating units 110 are helically arranged around the axis of the tubular member 100 , so that the tubular member 100 All said beams 104 are arranged around the axis of said tubular part 100 and form at least one said helical structure.
  • each repeating unit 110 includes one ring 103 , each repeating unit 110 also includes one beam 104 .
  • one repeating unit 110 is rotationally offset relative to the previous repeating unit 110, and the angle of the rotational offset is a, so that all The beams 104 form a helical structure (not shown in the figure), and the angle of rotation offset of one of the two adjacent beams 104 relative to the other is also a.
  • the previous repeating unit 110 refers to the one of the two adjacent repeating units 110 that is closer to the proximal end.
  • each repeating unit 110 when each repeating unit 110 includes one ring 103 , each repeating unit 110 also includes two beams 104 .
  • each repeating unit 110 is rotationally offset relative to the previous repeating unit 110, and the angle of the rotational offset is a, so that All the beams 104 form a first helical structure S 1 and a second helical structure S 2 parallel to each other, and the angle of rotation offset between two adjacent beams 104 on the same helical structure is also a.
  • each of the repeating units 110 includes more than two rings 103, and all the beams 104 in the same repeating unit 110 run along the tubular member 100
  • the circumferential direction of is divided into several beam groups 120, and the number of beams 104 included in each beam group 120 is equal to the number of rings 103 included in one repeating unit 110. All the beams 104 in the same beam group 120 are arranged in sequence along the axial direction, and at least some of the beams 104 in the same beam group 120 are aligned in the circumferential direction, or in the same beam group 120 All beams 104 of are staggered in the circumferential direction.
  • the number of the helical structures formed by all the beams 104 is the product of the number of the beam groups 120 and the number of the beams 104 in each beam group 120 .
  • each beam set 120 includes two The two beams 104 arranged in the axial direction are respectively a first beam 104a and a second beam 104b.
  • the first beam 104a and the second beam 104b are aligned in the circumferential direction of the tubular member 100 (as shown in FIG. 6b ), or the first beam 104a and the second beam 104b are aligned in the tubular member
  • the circumferential direction of 100 is staggered (as shown in Fig. 6c).
  • All the beams 104 form a first helical structure S 1 , a second helical structure S 2 , a third helical structure S 3 , a fourth helical structure S 4 , a fifth helical structure (not shown) and Sixth helix (not shown in figure).
  • the repeating unit 110 may also include more rings 103 , for example three.
  • all the beams 104 can form more spiral structures, for example, when two through grooves 102 are formed on the same circumference of the tubular member 100, and the repeating unit 110 includes three
  • all the beams 104 can form six helical structures.
  • all the beams 104 can form nine helical structures.
  • the medical guide wire 10 is used to insert into a target lumen, which may be a blood vessel.
  • the tubular member 100 is configured to increase its softness from the proximal end to the distal end, which is conducive to pushing.
  • 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 member 100 .
  • 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 is, the greater the flexibility of the tubular member 100 is.
  • the tubular member 100 can adjust the tubular member 100 by changing the ratio of the width D1 of the through groove 102 to the width D2 of the beam 104 and changing at least one of the length L of the repeating unit 110 Softness at any position.
  • the width D1 of the through groove 102 refers to the dimension of the through groove 102 in the circumferential direction of the tubular member 100
  • the width D2 of the beam 104 refers to the dimension of the beam 104 in the circumferential direction of the tubular member 100
  • the length L of the repeating unit 110 refers to the dimension of the repeating unit 110 in the axial direction of the tubular component 100 .
  • the target lumen includes several predetermined areas, and the predetermined areas are at least partially curved.
  • the tubular component 100 includes several sub-segments, and when the medical guide wire 10 is inserted into the target lumen, one of the sub-segments passes through a corresponding one. within the predetermined area.
  • the length L of the repeating unit 110 located on any one of the sub-sections, the angle a of the rotation offset between two adjacent repeating units 110 located in the sub-section (that is, two adjacent repeating units 110 The angle of rotation offset between the units 110), and the minimum curvature K of the predetermined area corresponding to the sub-section satisfy the following relationship (1): It is understood that K>0.
  • the rotations of two adjacent repeating units 110 are offset
  • the angle a may be the same value, or may be different values, which are specifically determined according to requirements.
  • the distal end of the medical guide wire 10 can enter the intracranial artery along the puncture port on the carotid artery of the human body.
  • the blood vessel is divided into sequentially connected first area 21, second area 22 and third area 23 according to the shape of the blood vessel, wherein the first area 21 It may be the end of the carotid artery, the second region 22 and the third region 23 are located in the cranium, and the first region 21, the second region 22 and the third region 23 all include curved parts, so the first region 21.
  • the second area 22 and the third area 23 are the predetermined areas. Please refer back to FIG.
  • the tubular member 100 includes a first sub-section 111a, a second sub-section 111b and a third sub-section 111c, the first sub-section 111a, the second sub-section 111b and the third subsection 111c are sequentially connected from the proximal end to the distal end.
  • the first subsection 111a is used to penetrate in the first region 21
  • the second subsection 111b is used to penetrate in the second region 22, and the third subsection
  • the segment 111c is used to pass through the third region 23 .
  • the cutting parameters of the first sub-section 111a, the second sub-section 111b and the third sub-section 111c can be determined according to the relational formula (1).
  • the length of the repeating unit 110 located at the first subsection 111a, the angle of rotation offset between two adjacent repeating units 110 located at the first subsection 111a, and The minimum curvature of the first region 21 conforms to the relationship (1).
  • the length of the repeating unit located at the second subsection 111b, the angle of rotation offset between two adjacent repeating units 110 located at the second subsection 111b, and the second The minimum curvatures of the two regions 22 conform to the relation (1).
  • the length of the repeating unit 110 located at the third subsection 111c, the angle of rotation offset between two adjacent repeating units 110 located at the third subsection 111c, and The minimum curvature of the third region 23 conforms to the relationship (1).
  • the embodiment of the present invention can reasonably set the cutting parameters of at least a part of the segments of the tubular component 100 according to the curvature of each region of the target lumen, so that the softness of each sub-segment of the tubular component 100 Adapt to the curvature changes of the corresponding predetermined regions, so that the softness of the medical guide wire 10 matches the curvature changes of each predetermined region of the target lumen.
  • the flexibility of the medical guide wire 10 is in an appropriate range, that is, the medical guide wire 10 is neither too soft nor too hard, and can maintain good supporting performance and control cutting costs.
  • the tubular component 100 also includes a fourth subsection 111d and a fifth subsection 111e, wherein the fourth subsection 111d is connected to the proximal end of the first subsection 111a, and the fifth The subsection 111e is connected to the proximal end of the fourth subsection 111d, and the fourth subsection 111d and the fifth subsection 111e are used to pass through the straight section of the carotid artery (in the figure not shown), therefore, the softness of the fourth subsection 111d and the fifth subsection 111e only needs to meet the requirement of increasing along the direction from the proximal end to the distal end.
  • the length of the sub-segment is greater than the length of the predetermined region corresponding to the sub-segment
  • 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.
  • the length of the first subsection 111a is greater than the length of the first region 21, and the pitch of the helical structure on the first subsection 111a is greater than the The length of the first region 21; the length of the second subsection 111b is greater than the length of the second region 22, and the pitch of the helical structure on the second subsection 111b is greater than that of the second region 22 length; the length of the third subsection 111c is greater than the length of the third region 23, and the pitch of the helical structure on the third subsection 111c is greater than the length of the third region 23 .
  • 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 once.
  • the pitch is the distance traveled by the helical structure The distance between two ends of a helical turn 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 form.
  • the length of the second region 22 refers to the size of the first region 21 of the blood vessel.
  • the length of the third region 23 refers to the length of the third region 23 of the blood vessel when stretched into a linear shape. The dimensions of the area.
  • 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 combined with relational expression (1)
  • the related parameters of obtaining the first subsection 111a, the second subsection 111b and the third subsection 111c of the tubular component 100 are shown in Table 1.
  • the relevant parameters include The length L of the repeating unit 110 and the angle a of the rotational offset between two adjacent beams 104 on the same helical structure.
  • the outer diameter of the mandrel 200 decreases from the proximal end to the distal end, so that the softness of the medical guide wire 10 increases from the proximal end to the distal end.
  • the first segment 210 may include a proximal segment 211, a first transition segment 212, a first intermediate segment 213, and a second transition segment sequentially connected from the proximal end to the distal end. 214 , the second middle section 215 and the third transition section 216 .
  • the proximal section 211 has a uniform outer diameter.
  • the first transition section 212 is a tapered section whose cross section decreases along the direction from the proximal end to the distal end, and the maximum outer diameter of the first transition section 212 is equal to the outer diameter of the proximal section 211 .
  • the first intermediate section 213 has a uniform outer diameter, and the outer diameter of the first intermediate section 213 is equal to the smallest outer diameter of the first transition section 212 .
  • the second transition section 214 is a tapered section whose cross section decreases from the proximal end to the distal end, and the maximum outer diameter of the second transition section 214 is equal to the outer diameter of the first intermediate section 213 .
  • the second intermediate section 215 has a uniform outer diameter, and the outer diameter of the second intermediate section 215 is equal to the smallest outer diameter of the second transition section 214 .
  • the third transition section 216 is also a tapered section, the cross section of which decreases along the direction from the proximal end to the distal end, and the maximum outer diameter of the third transition section 216 is equal to the outer diameter of the second intermediate section 215. path.
  • the second section 220 of the mandrel 200 may have a uniform outer diameter, and its outer diameter is equal to the smallest outer diameter of the third transition section 216 . It should be noted that, in some implementations, the cross-section at any position of the second segment 220 is circular (as shown in FIG.
  • the second segment 220 The cross section at at least a part of the position is a flat shape, and the flat shape includes waist circle (as shown in FIG. 9b ), ellipse or rectangle, etc.
  • the outer diameter of the second segment 220 is refers to the diameter of the circumscribed circle of the cross section at any position of the second segment 220 .
  • the cross section at at least a part of the mandrel 200 is the flat shape, specifically, the cross section at any position of the second segment 220 is the flat shape.
  • the cross-section of the proximal part of the second segment 220 is circular, and the cross-section of the distal part of the second segment 220 is flat.
  • the plasticity of the distal end of the mandrel 200 can be improved, and further the plasticity of the distal end of the medical guide wire 10 can be improved, so that the operator can conveniently adjust the medical guide wire 10 when actually using the medical guide wire 10.
  • the distal end of the medical guide wire 10 is bent.
  • the mandrel 200 can also have a second lumen 201 extending axially through, and the second lumen 201 can be used to transport other components to the target position.
  • the distal end portion of the second section 220 of the mandrel 200 can be connected to a non-traumatic junction 300 (as shown in FIGS. 1 , 3 , 11a, 11b and 11c ).
  • the distal ends of the tubular member 100 are connected.
  • the joint part 300 can be formed by dispensing or hot melting, and can also be formed by welding.
  • the medical guide wire 10 further includes a developing element 400 for displaying the position of the tubular component 100 .
  • the developing element 400 can be disposed in the first inner cavity 101 and sleeved on the second section 220 of the mandrel 200 .
  • the developing element 400 may specifically be a developing spring or a developing ring, and the embodiment of the present invention does not limit the number of the developing element 400, which may be one (as shown in 11a) or multiple (as shown in FIG. 11b and FIG. 11c ), when the number of the developing elements 400 is multiple, the multiple developing elements 400 can be arranged continuously, or arranged at intervals along the axial direction of the tubular member 100 .
  • the medical guide wire 10 may also include a filling element, and the filling element is filled in the first lumen to further improve the distal end portion of the medical guide wire 10 (ie, the tubular member 100 The plasticity of the area in which it is located).
  • the developing element 400 constitutes at least a part of the filling element.
  • the cutting parameters of the sub-segments of the tubular part of the interventional device that match the predetermined area are determined by the length and minimum curvature of the predetermined area of the target lumen, and the The degree of matching between the softness of the interventional device and the target lumen is conducive to inserting the interventional device into the target lumen and making the distal end of the interventional device smoothly pushed into the target lumen. target location.

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Abstract

一种介入装置，插入包括若干预定区域的目标管腔，预定区域至少部分弯曲；介入装置包括具有多个环(103)和多个梁(104)的管状部件(100)，梁(104)连接多个环(103)；除位于管状部件(100)的指定端的一个环(103)外，管状部件(100)的其他部分包括多个重复单元(110)，重复单元(110)包括至少一个环(103)和连接于环(103)上并向指定端延伸的梁(104)；相邻两个重复单元(110)中之间旋转偏移；管状部件(110)包括若干子节段，每个子节段穿设在一个预定区域内；位于任一个子节段的重复单元(110)的长度L、位于该子节段且相邻的两个重复单元(110)之间旋转偏移的角度a、以及与该子节段相对应的预定区域的最小曲率K满足关系： (I) ，K＞0。介入装置根据目标管腔的相关参数来确定管状部件(100)的切割参数，有利于使介入装置的远端抵达目标位置。

Description

一种介入装置 技术领域
本发明涉及医疗器械技术领域，具体涉及一种介入装置。
背景技术
心脑血管疾病严重影响了人们的身体健康和生活质量。血管介入手术是治疗心脑血管疾病的重要手段，其与传统的外科手术治疗相比具有创伤小、术后恢复快等优点。血管介入手术的过程通常包括使用穿刺针穿刺人体体表浅动脉或浅静脉，接着使用医用导丝经穿刺点切口进入人体血管系统，并利用所述医用导丝引导其他器械进入血管并抵达病灶。因此，医用导丝对于血管介入手术来说至关重要，医用导丝能否到达并通过病变位置，在很大程度上影响了手术的成功与否。
现有技术中的医用导丝通常包括芯轴和套装在芯轴之远端部分的海波管，通过海波管上的切槽实现医用导丝的柔顺性与扭控性并存的效果，但是这些医用导丝的柔顺性及支撑性能的变化不符合血管弯曲段的变化，使得医用导丝的远端难以到达病变位置。
发明内容
本发明的目的在于提供一种介入装置，其柔顺性的变化能够顺应血管弯曲段的变化，并顺利抵达病变位置。
为实现上述目的，本发明提供了一种介入装置，用于插入目标管腔，所述目标管腔包括若干预定区域，所述预定区域至少部分弯曲；所述介入装置包括具有第一内腔的管状部件，所述管状部件的侧壁上设置有多个与所述第一内腔相连通的贯穿槽，以使得所述管状部件上形成多个沿周向延伸的环和多个沿轴向延伸并连接所述环的梁；
除位于所述管状部件的指定端的一个所述环以外，所述管状部件的其他部分被划分为多个重复单元，每一个所述重复单元包括至少一个所述环和连接于所述环上，并向所述指定端延伸的所述梁；相邻两个所述重复单元中的一个相对于另一个旋转偏移，以使得多个所述重复单元绕所述管状部件的轴线螺旋排布；所述指定端为远端或近端；
所述管状部件包括若干子节段，且一个所述子节段用于穿设在一个所述预定区域内；位于任一个所述子节段上的所述重复单元的长度L、位于该子节段且相邻的两个所述重复单元之间的旋转偏移的角度a、以及与该子节段相对应的所述预定区域的最小曲率K满足如下关系：
Figure PCTCN2022139157-appb-000001
K＞0。
可选地，任一个所述子节段的长度大于与该子节段对应的所述预定区域的长度。
可选地，所述螺旋结构在任一个所述子节段上的节距大于或等于与该子节段相应的所述预定区域的长度。
可选地，所有的所述梁绕所述管状部件的轴线排布并形成至少一个螺旋结构；所述重复单元包括至少一个所述环；当所述重复单元包括两个以上的所述环时，所述重复单元中的所有所述梁沿所述管状部件的周向被划分为若干个梁组，且每个所述梁组包括的所述梁的数量与所述重复单元包括的所述环的数量相等；同一个所述梁组中的所有所述梁沿轴向依次布置，并位于不同的所述螺旋结构上，且同一个所述梁组中的至少部分所述梁在周向上对齐，或者同一个所述梁组中的所有所述梁在周向上错开。
可选地，所述管状部件的柔软度沿近端向远端的方向增大。
可选地，所述介入装置还包括芯轴，所述芯轴包括第一节段和连接于所述第一节段之远端的第二节段，所述第二节段的外径小于或等于所述第一节段的最小外径，且所述第二节段设置于所述管状部件的所述第一内腔中，并与所述管状部件连接；所述介入装置的柔软度沿近端向远端的方向增大。
可选地，所述芯轴具有沿其轴向贯通地延伸的第二内腔。
可选地，所述第二节段的横截面为圆形；或者，所述第二节段的横截面为扁平形状；或者，所述第二节段的近端部分的横截面为圆形，所述第二节段的远端部分的横截面为扁平形状；所述扁平形状包括腰圆形、椭圆形或矩形中的任一种。
可选地，所述介入装置还包括显影元件，所述显影元件用于显示所述管状部件的位置。
可选地，所述显影元件设置于所述第一内腔中，并套装在所述芯轴上。
可选地，所述介入装置还包括填充元件，所述填充元件填充于所述第一内腔中。
可选地，所述介入装置还包括无创伤性的接合部，所述接合部设置于所述介入装置的远端，并使所述管状部件的远端与所述芯轴的远端连接。
与现有技术相比，本发明的介入装置具有如下优点：
前述的介入装置用于插入一目标管腔，所述目标管腔包括若干预定区域，所述预定区域至少部分弯曲；所述目标管腔包括所述介入装置包括具有第一内腔的管状部件，所述管状部件的侧壁上设置有多个与所述第一内腔相连通的贯穿槽，并使所述管状部件上形成多个沿周向延伸的环和多个沿轴向延伸并连接所述环的梁；除位于所述管状部件的指定端的一个所述环以外，所述管状部件的其他部分被划分为多个重复单元，每一个所述重复单元包括至少一个所述环和连接于所述环上，并向所述指定端延伸的所述梁；相邻两个所述重复单元中的一个相对于另一个旋转偏移，以使得多个所述重复单元绕所述管状部件的轴线螺旋排布；所述指定端为远端或近端；所述管状部件包括若干子节段，且一个所述子节段用于穿设在一个所述预定区域内；位于任一个所述子节段上的所述重复单元的长度L、位于该子节段且相邻的两个所述重复单元之间旋转偏移的角度a、以及与该子节段相对应的所述预定区域的最小 曲率K满足如下关系：
Figure PCTCN2022139157-appb-000002
K＞0。如此设置，可使得所述管状部件的任一个子节段的柔软度与与该子节段相对应的预定区域的曲率变化相适应，进而使得所述介入装置对应于该子节段的部分与所述预定区域的曲率变化相匹配，有利于将所述介入装置推送至目标管腔，并使所述介入装置的远端抵达所述目标管腔内的目标位置。
进一步地，任一个所述子节段的长度大于与该子节段相对应的所述预定区域的长度，并优选所述螺旋结构在任一个所述子节段上的节距大于或等于与该子节段对应的所述预定区域的长度，以确保所述介入装置的远端抵达所述目标管腔的目标位置。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。
图1是本发明根据一实施例所提供的医用导丝的结构示意图。
图2是本发明根据一实施例所提供的医用导丝的芯轴的结构示意图。
图3是本发明根据一实施例所提供的医用导丝的局部剖视图。
图4a是本发明根据一实施例所提供的医用导丝的管状部件的结构示意图，图中贯穿槽的平面展开形状为直角矩形。
图4b是发明根据一实施例所提供的医用导丝的管状部件的结构示意图，图中贯穿槽的平面展开形状为圆角矩形。
图5a是本发明根据一实施例所提供的医用导丝的管状部件的径向剖视图，图中相邻的两个环之间通过一个梁连接。
图5b是本发明根据一实施例所提供的医用导丝的管状部件的径向剖视图，图中相邻的两个环之间通过二个梁连接。
图5c是本发明根据一实施例所提供的医用导丝的管状部件的径向剖视图，图中相邻的两个环之间通过三个梁连接。
图6a是本发明根据一实施例所提供的医用导丝的管状部件的局部放大示意图，图中的每个重复单元包括一个环。
图6b是本发明根据一实施例所提供的医用导丝的管状部件的局部放大示意图，图中的每个重复单元包括两个环，且同一个梁组中的两个梁在管状部件的周向上对齐。
图6c是本发明根据一实施例所提供的医用导丝的管状部件的局部放大示意图，图中每一个重复单元包括两个环，且同一个梁组中的两个梁在管状部件的周向上错开。
图7是本发明实施例所提供的医用导丝的使用场景示意图。
图8是人体血管的局部示意图，图中虚线为第一区域、第二区域及第三区域的分界线。
图9a是图2所提供的医用导丝的芯轴的第二节段的径向剖视图，图中芯轴的横截面为圆形。
图9b是图2所提供的医用导丝的芯轴的第二节段的径向剖视图，图中芯轴的横截面为腰圆形。
图10是本发明根据一实施例所提供的医用导丝的芯轴的轴向剖视图。
图11a是本发明根据一实施例所提供的医用导丝的局部剖视图，图中示出显影元件，且显影元件包括一个显影弹簧。
图11b是本发明根据一实施例所提供的医用导丝的局部剖视图，图中示出显影元件，且显影元件包括两个显影弹簧。
图11c是本发明根据一实施例所提供的医用导丝的局部剖视图，图中示出显影元件，且显影元件包括若干个显影环。
附图中：10-医用导丝；100-管状部件，101-第一内腔，102-贯穿槽，103-环，104-梁，104a-第一梁，104b-第二梁，110-重复单元，120-梁组，111a-第一子节段，111b-第二子节段，111c-第三子节段，111d-第四子节段，111e-第 五子节段，200-芯轴，210-第一节段，211-近端节段，212-第一过渡段，213-第一中间节段，214-第二过渡段，215-第二中间节段，216-第三过渡段，220-第二节段，201-第二内腔；300-接合部；400-显影元件；21-第一区域，22-第二区域，23-第三区域。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的型态、数量及比例可为一种随意的改变，且其组件布局型态也可能更为复杂。
另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接， 也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本文中，术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
本发明的核心思想在于提供一种介入装置，所述介入装置用于插入目标管腔，且所述介入装置的远端用于到达所述目标管腔中的一目标位置。本发明通过对所述介入装置的结构进行合理设置，以使所述介入装置在兼具柔顺性和扭控性的效果的情况下，还使得所述介入装置的柔顺性和支撑性能够顺应所述目标管腔的弯曲段的曲率变化，进而确保所述介入装置的远端能够抵达所述目标位置。
为实现上述目的，所述介入装置包括具有第一内腔的管状部件，所述管状部件的侧壁上设有多个与所述第一内腔相连通的贯穿槽，以使得所述管状部件上形成多个沿周向延伸的环和多个连接所述环的梁。除位于所述管状部件的指定端的一个所述环以外，所述管状部件的其他部分被划分为多个重复单元，每一个所述重复单元包括至少一个所述环和连接于所述环上，并向所述指定端延伸的所述梁；相邻两个所述重复单元中的一个相对于另一个旋转偏移，以使得多个所述重复单元绕所述管状部件的轴线螺旋排布；所述指定端为远端或近端；所述管状部件包括若干子节段，一个所述子节段用于穿设在所述目标管腔的一个预定区域内，所述预定区域至少部分弯曲。位于任一个所述子节段上的所述重复单元的长度L、位于该子节段且相邻的两个所述重复单元之间旋转偏移的角度a、以及与该子节段相对应的所述预定区域的最小曲率K满足如下关系：
Figure PCTCN2022139157-appb-000003
K＞0。
在本发明的一些实施例中，所述介入装置可以是医用导管。在本发明的另一些实施例中，所述介入装置可以是医用导丝。
为使本发明的目的、优点和特征更加清楚，以下结合附图并以所述介入装置为医用导丝为例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
如图1至图3所示，所述医用导丝10包括管状部件100和芯轴200。所述管状部件100具有第一内腔101。所述芯轴200包括第一节段210和连接于所述第一节段210之远端的第二节段220，所述第二节段220的外径小于或等于所述第一节段210的最小外径，且所述第二节段220设置于所述管状部件100的所述第一内腔101中，并与所述管状部件100连接。所述医用导丝10的柔软度沿近端向远端增大。
其中，如图4a及图4b所示，所述管状部件100的原材料为一圆柱状管材，通过激光切割或机械切割的方式在所述管材的侧壁上切割形成多个与所述第一内腔101相连通的贯穿槽102，以使得所述管状部件100上形成多个沿周向延伸的环103和多个连接相邻两个所述环103的梁104。所述贯穿槽102的平面展开形状可以是直角长方形(如图4a所示)，也可以是圆角长方形(如图4b所示)，还可以是腰圆形。以及，在所述管状部件100的同一圆周上，可以切割形成至少一个所述贯穿槽102，具体可以是一个(如图5a所示)、两个(如图5b所示)、三个(如图5c所示)，或者更多个，本发明实施例对此不作限定。
可选地，请返回参考图1，并结合图6a至图6c，除位于所述管状部件100的指定端的端部的一个所述环103以外，所述管状部件100的其他部分被划分为多个重复单元110。所述指定端可以是远端，也可以是近端，本文中以远端为所述指定端为例进行说明。每个所述重复单元110包括至少一个所述环 103和连接于所述环103上并向远端延伸的所述梁104。相邻两个所述重复单元110中的一者相对于另一者旋转偏移，以使得多个所述重复单元110绕所述管状部件100的轴线螺旋排列，进而使得所述管状部件100的所有的所述梁104绕所述管状部件100的轴线排布并形成至少一个所述螺旋结构。
举例来说，如图5a所示，所述管状部件100的同一个圆周上形成一个所述贯穿槽102，以使得相邻两个所述环103之间通过一个所述梁104连接。如此，当每个所述重复单元110包括一个所述环103时，每个所述重复单元110还包括一个所述梁104。沿近端到远端的方向，从第二个所述重复单元110开始，一个所述重复单元110相对于上一个所述重复单元110旋转偏移，旋转偏移的角度为a，以使得所有的所述梁104形成一个所述螺旋结构(图中未示出)，且相邻两个所述梁104中的一者相对于另一者旋转偏移的角度也为a。在此，所述上一个重复单元110是指相邻的两个重复单元110中更靠近近端的一个。
或者，如图5b所示，所述管状部件100的同一圆周上形成两个相互间隔的所述贯穿槽102，以使得相邻两个所述环103之间通过两个所述梁104连接，优选两个所述梁104沿所述管状部件100的周向等间距地布置。如图6a所示，当每个所述重复单元110包括一个所述环103时，每个所述重复单元110还包括两个所述梁104。沿近端到远端的方向，从第二个所述重复单元110开始，每个所述重复单元110相对于上一个所述重复单元110旋转偏移，旋转偏移的角度为a，以使得所有的所述梁104形成相互平行的第一螺旋结构S 1及第二螺旋结构S 2，且同一个所述螺旋结构上的相邻两个所述梁104之间旋转偏移的角度也为a。
又或者，如图6b及图6c所示，每个所述重复单元110包括两个以上的所述环103，并且同一个所述重复单元110中的所有所述梁104沿所述管状部件100的周向被划分为若干个梁组120，每个所述梁组120中包括的所述梁104 的数量与一个所述重复单元110中包括的所述环103的数量相等。同一个所述梁组120中的所有所述梁104沿轴向依次布置，且同一个所述梁组120中的至少部分所述梁104在周向上对齐，或者同一个所述梁组120中的所有梁104在周向上错开。由于多个所述重复单元110螺旋排布，因此不同的所述重复单元110的对应的所述梁组120螺旋排布，且同一个所述梁组120中的所有梁104位于不同的所述螺旋结构上，这样一来，所有的所述梁104所形成的所述螺旋结构的数量为所述梁组120的数量与每一个所述梁组120中的所述梁104的数量的乘积。具体地，仍以所述管状部件100的同一个圆周上形成两个所述贯穿槽102为例，请继续参考图6b及图6c，当所述重复单元110包括两个所述环103，每个所述重复单元110中包括三个所述梁组120(也即所述管状部件100的同一圆周上形成三个相互间隔的所述贯穿槽102)时，每个所述梁组120包括两个沿轴向布置的所述梁104，分别为第一梁104a和第二梁104b。所述第一梁104a和所述第二梁104b在所述管状部件100的周向上对齐(如图6b所示)，或者所述第一梁104a和所述第二梁104b在所述管状部件100的周向上错开(如图6c所示)。所有的所述梁104形成相互平行的第一螺旋结构S 1、第二螺旋结构S 2、第三螺旋结构S 3、第四螺旋结构S 4、第五螺旋结构(图中未示出)及第六螺旋结构(图中未示出)。
当然，所述重复单元110中也可以包括更多个所述环103，例如三个。相应地，所有的所述梁104可以形成更多个所述螺旋结构，例如，当所述管状部件100的同一圆周上形成两个所述贯穿槽102，且所述重复单元110包括三个所述环103时，所有的所述梁104可以形成六个所述螺旋结构。当所述管状部件100的同一个圆周上形成三个所述贯穿槽102，且所述重复单元110包括三个所述环103时，所有的所述梁104可以形成九个所述螺旋结构。
如图7所示，所述医用导丝10用于插入目标管腔，所述目标管腔可以是血管。所述管状部件100被配置为其柔软度由近端向远端的方向增大，有利 于推送。通常，当所述重复单元110的长度L保持不变时，所述贯穿槽102的宽度D1与所述梁104的宽度D2的比值越大，所述管状部件100的柔软度越大。以及，在所述贯穿槽102的宽度D1与所述梁104的宽度D2的比值保持不变的情况下，所述重复单元110的长度L越小，所述管状部件100的柔软度越大。故而，本领域技术人员可以通过改变所述贯穿槽102的宽度D1与所述梁104的宽度D2的比值，以及改变所述重复单元110的长度L中的至少一者来调整所述管状部件100在任意位置处的柔软度。所述贯穿槽102的宽度D1是指所述贯穿槽102在所述管状部件100的周向上的尺寸，以及所述梁104的宽度D2是指所述梁104在所述管状部件100的周向上的尺寸，所述重复单元110的长度L是指所述重复单元110在所述管状部件100的轴向上的尺寸。
不仅于此，所述目标管腔包括若干个预定区域，且所述预定区域至少部分弯曲。与之相应地，本发明实施例中，所述管状部件100包括若干个子节段，当所述医用导丝10插入所述目标管腔内时，一个所述子节段穿设在相应的一个所述预定区域内。位于任一个所述子节段上的所述重复单元110的长度L、位于该子节段且相邻两个所述重复单元110之间旋转偏移的角度a(也即相邻两个重复单元110之间旋转偏移的角度)、以及与该子节段相对应的所述预定区域的最小曲率K满足如下关系式(1)：
Figure PCTCN2022139157-appb-000004
可以理解的是，K＞0。另外，需要说明的是，在所述管状部件100的不同子节段，相邻两个所述重复单元110(或者说是同一螺旋结构中的相邻两个所述梁104)的旋转偏移的角度a可能是相同的数值，也可能是不同的数值，具体根据需要确定。
举例来说，所述医用导丝10的远端可以沿人体的颈部动脉上的穿刺口进入颅内动脉。如图8所示，从颈部动脉的一指定位置开始，根据血管的形态将血管划分为依次连接的第一区域21、第二区域22和第三区域23，其中，所述第一区域21可以为颈部动脉末端，所述第二区域22及所述第三区域23 位于颅内，且第一区域21、第二区域22及第三区域23均包括弯曲部分，如此所述第一区域21、所述第二区域22及所述第三区域23为所述预定区域。请再返回参考图1，所述管状部件100包括第一子节段111a、第二子节段111b和第三子节段111c，所述第一子节段111a、所述第二子节段111b及所述第三子节段111c沿近端向远端依次连接。其中，所述第一子节段111a用于穿设在所述第一区域21内、所述第二子节段111b用于穿设在所述第二区域22内、所述第三子节段111c用于穿设在所述第三区域23内。那么，所述第一子节段111a、所述第二子节段111b及所述第三子节段111c的切割参数可根据所述关系式(1)来确定。具体是位于所述第一子节段111a处的所述重复单元110的长度、位于所述第一子节段111a且相邻的两个所述重复单元110之间旋转偏移的角度、以及所述第一区域21的最小曲率之间符合所述关系式(1)。位于所述第二子节段111b处的所述重复单元的长度、位于所述第二子节段111b且相邻的两个所述重复单元110之间旋转偏移的角度、以及所述第二区域22的最小曲率之间符合所述关系式(1)。以及，位于所述第三子节段111c处的所述重复单元110的长度、位于所述第三子节段111c且相邻的两个所述重复单元110之间旋转偏移的角度、以及第三区域23的最小曲率之间符合所述关系式(1)。也即本发明实施例可以根据所述目标管腔的各个区域的曲率来合理设置所述管状部件100的至少一部分节段的切割参数，以使得所述管状部件100的各个子节段的柔软度与相应的预定区域的曲率变化相适应，进而使得所述医用导丝10的柔软度随目标管腔的各个预定区域的曲率变化相匹配。如此一来，所述医用导丝10的柔顺性处于合适的范围，即所述医用导丝10既不会过软，也不会过硬，还能够保持良好的支撑性能，并控制切割成本。
此外，所述管状部件100还包括第四子节段111d和第五子节段111e，其中所述第四子节段111d连接于所述第一子节段111a的近端，所述第五子节段111e连接于所述第四子节段111d的近端，所述第四子节段111d及所述第五 子节段111e用于穿设在颈部动脉的平直段(图中未示出)内，因此所述第四子节段111d和所述第五子节段111e的柔软度只需要符合沿近端向远端的方向增大的要求即可。
为确保所述医用导丝10的远端抵达所述目标管腔内的预定位置，本实施例中还优选所述子节段的长度大于与该子节段相对应的所述预定区域的长度，以及所述螺旋结构在所述子节段上的节距大于或等于与该子节段相对应的所述预定区域的长度。针对图8所示的血管来说，所述第一子节段111a的长度大于所述第一区域21的长度，所述螺旋结构在所述第一子节段111a上的节距大于所述第一区域21的长度；所述第二子节段111b的长度大于所述第二区域22的长度，所述螺旋结构在所述第二子节段111b上的节距大于所述第二区域22的长度；所述第三子节段111c的长度大于所述第三区域23的长度，所述螺旋结构在所述第三子节段111c上的节距大于所述第三区域23的长度。可以理解，所述节距是指所述螺旋结构旋转一周时，所述螺旋结构在所述管状部件100的轴向上所走过的距离，换句话说，所述节距是所述螺旋结构的一个螺旋圈的两端在所述管状部件100的轴向上的距离。所述第一区域21的长度是指所述将血管的所述第一区域21拉伸为线型形态时该区域的尺寸，同理，所述第二区域22的长度是指所述将血管的所述第二区域22拉伸为线型形态时该区域的尺寸，以及，所述第三区域23的长度是指所述将血管的所述第三区域23拉伸为线型形态时该区域的尺寸。
仍以图8所示的血管为例，由临床解剖数据获得所述第一区域21、所述第二区域22、以及所述第三区域23的长度及最小曲率，并结合关系式(1)获得一所述管状部件100的所述第一子节段111a、所述第二子节段111b及所述第三子节段111c相关参数如表1所示，相关参数包括位于各个子节段的所述重复单元110的长度L，以及同一螺旋结构上的相邻两个所述梁104之间旋转偏移的角度a。
表1
Figure PCTCN2022139157-appb-000005
请返回参考图2，所述芯轴200的外径沿近端向远端的方向减小，进而使得所述医用导丝10的柔软度沿近端向远端增大。在一个可选的实现方式中，所述第一节段210可包括沿近端向远端依次连接的近端节段211、第一过渡段212、第一中间节段213、第二过渡段214、第二中间节段215及第三过渡段216。其中，所述近端节段211具有均一的外径。所述第一过渡段212为锥形段，其横截面沿近端向远端的方向减小，且所述第一过渡段212的最大外径等于所述近端节段211的外径。所述第一中间节段213具有均一的外径，所述第一中间节段213的外径等于所述第一过渡段212的最小外径。所述第二过渡段214为锥形段，其横截面沿近端向远端的方向减小，且所述第二过渡段214的最大外径等于所述第一中间节段213的外径。所述第二中间节段215具有均一的外径，所述第二中间节段215的外径等于所述第二过渡段214的最小外径。所述第三过渡段216也为锥形段，其横截面沿近端向远端的方向减小，且所述第三过渡段216的最大外径等于所述第二中间节段215的外径。所述芯轴200之所述第二节段220可具有均一的外径，且其外径等于所述第三过渡段216的最小外径。需要说明的是，在一些实施方式中，所述第二节段220的任意位置处的横截面为圆形(如图9a所示)，在另一些实现方式中，所述第二节段220的至少一部分位置处的横截面为扁平形状，所述扁平形状包括腰圆形(如图9b所示)、椭圆形或矩形等，这种情况下，所述第二节段220的外径是指所述第二节段220任意位置处的横截面的外接圆的直径。
优选地，所述芯轴200的至少一部分位置处的横截面为所述扁平形状，具体地，所述第二节段220的任意位置处的横截面为扁平形状。或者所述第二节段220的近端部分的横截面为圆形，所述第二节段220的远端部分的横截面为扁平形状。这样做，可以改善所述芯轴200之远端的可塑性，进而提升所述医用导丝10的远端的可塑性，使得施术者在实际使用所述医用导丝10时，能够方便地对所述医用导丝10的远端进行弯曲。
此外，如图10所示，所述芯轴200还可以具有轴向贯通地延伸的第二内腔201，所述第二内腔201可以用于将其他部件传输至目标位置。
以及，所述芯轴200之所述第二节段220的远端端部可通过一无创伤性的接合部300(如图1、图3、图11a、图11b及图11c所示)与所述管状部件100的远端端部连接。所述接合部300可通过点胶或热熔方式形成，也可以通过焊接形成。
进一步地，如图11a至图11c所示，所述医用导丝10还包括显影元件400，所述显影元件400用于显示所述管状部件100的位置。所述显影元件400可设置于所述第一内腔101内并套装在所述芯轴200的所述第二节段220上。所述显影元件400具体可以是显影弹簧或者显影环，且本发明实施例对所述显影元件400的数量也不作限定，其可以是一个(如11a所示)，也可以是多个(如图11b及图11c所示)，当所述显影元件400的数量为多个时，多个所述显影元件400可连续布置，也可以沿所述管状部件100的轴向间隔地布置。
较佳地，所述医用导丝10还可以包括填充元件，所述填充元件填充于所述第一内腔中，以进一步改善所述医用导丝10的远端部分(即所述管状部件100所在的区域)的可塑性。可选地，所述显影元件400构成至少一部分的所述填充元件。
本发明实施例所提供的介入装置中，通过目标管腔的预定区域的长度及最小曲率来确定所述介入装置之管状部件的与所述预定区域相匹配的子节段 的切割参数，提高所述介入装置的柔软度与所述目标管腔的匹配度，进而有利于将所述介入装置插入所述目标管腔，并使所述介入装置的远端顺利推入所述目标管腔内的目标位置。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

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  1. 一种介入装置，用于插入目标管腔，所述目标管腔包括若干预定区域，所述预定区域至少部分弯曲；其特征在于，所述介入装置包括具有第一内腔的管状部件，所述管状部件的侧壁上设置有多个与所述第一内腔相连通的贯穿槽，以使得所述管状部件上形成多个沿其周向延伸的环和多个连接所述环的梁；
    除位于所述管状部件的指定端的一个所述环以外，所述管状部件的其他部分被划分为多个重复单元，每一个所述重复单元包括至少一个所述环和连接于所述环上，并向所述指定端延伸的所述梁；相邻两个所述重复单元中的一个相对于另一个旋转偏移，以使得多个所述重复单元绕所述管状部件的轴线螺旋排布；所述指定端为远端或近端；
    所述管状部件包括若干子节段，且一个所述子节段用于穿设在一个所述预定区域内；位于任一个所述子节段上的所述重复单元的长度L、位于该子节段且相邻的两个所述重复单元之间旋转偏移的角度a、以及与该子节段相对应的所述预定区域的最小曲率K满足如下关系：
    Figure PCTCN2022139157-appb-100001
  2. 根据权利要求1所述的介入装置，其特征在于，任一个所述子节段的长度大于与该子节段对应的所述预定区域的长度。
  3. 根据权利要求1所述的介入装置，其特征在于，所述螺旋结构在任一个所述子节段上的节距大于或等于与该子节段相应的所述预定区域的长度。
  4. 根据权利要求1所述的介入装置，其特征在于，所有的所述梁绕所述管状部件的轴线排布并形成至少一个螺旋结构；所述重复单元包括至少一个所述环；当所述重复单元包括两个以上的所述环时，所述重复单元中的所有所述梁沿所述管状部件的周向被划分为若干个梁组，且每个所述梁组包括的所述梁的数量与所述重复单元包括的所述环的数量相等；同一个所述梁组中 的所有所述梁沿轴向依次布置，并位于不同的所述螺旋结构上，且同一个所述梁组中的至少部分所述梁在所述周向上对齐，或者同一个所述梁组中的所有所述梁在所述周向上错开。
  5. 根据权利要求1所述的介入装置，其特征在于，所述管状部件的柔软度沿近端向远端的方向增大。
  6. 根据权利要求1-5中任一项所述的介入装置，其特征在于，所述介入装置还包括芯轴，所述芯轴包括第一节段和连接于所述第一节段之远端的第二节段，所述第二节段的外径小于或等于所述第一节段的最小外径，且所述第二节段设置于所述管状部件的所述第一内腔中，并与所述管状部件连接；所述介入装置的柔软度沿近端向远端的方向增大。
  7. 根据权利要求6所述的介入装置，其特征在于，所述芯轴具有沿其轴向贯通地延伸的第二内腔。
  8. 根据权利要求6所述的介入装置，其特征在于，所述第二节段的横截面为圆形；或者，所述第二节段的横截面为扁平形状；或者，所述第二节段的近端部分的横截面为圆形，所述第二节段的远端部分的横截面为扁平形状；所述扁平形状包括腰圆形、椭圆形或矩形中的任一种。
  9. 根据权利要求6所述的介入装置，其特征在于，所述介入装置还包括显影元件，所述显影元件用于显示所述管状部件的位置。
  10. 根据权利要求9所述的介入装置，其特征在于，所述显影元件设置于所述第一内腔中，并套装在所述芯轴上。
  11. 根据权利要求6所述的介入装置，其特征在于，所述介入装置还包括填充元件，所述填充元件填充于所述第一内腔中。
  12. 根据权利要求6所述的介入装置，其特征在于，所述介入装置还包括无创伤性的接合部，所述接合部设置于所述介入装置的远端，并使所述管状部件的远端与所述芯轴的远端连接。
PCT/CN2022/139157 2021-12-30 2022-12-15 一种介入装置 WO2023125027A1 (zh)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004012804A2 (en) * 2002-08-05 2004-02-12 Boston Scientific Limited Medical device with collapse-resistant liner and method of making same
US20110160680A1 (en) * 2009-12-29 2011-06-30 Cook Incorporated Wire guide with cannula
CN202020777U (zh) * 2011-03-31 2011-11-02 先健科技(深圳)有限公司 可调弯导管
CN104812420A (zh) * 2012-08-17 2015-07-29 波士顿科学西美德公司 引导延伸导管
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