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WO2021047604A1 - Structure d'implant intracavitaire et filtre de veine cave ayant ladite structure - Google Patents

Structure d'implant intracavitaire et filtre de veine cave ayant ladite structure Download PDF

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Publication number
WO2021047604A1
WO2021047604A1 PCT/CN2020/114575 CN2020114575W WO2021047604A1 WO 2021047604 A1 WO2021047604 A1 WO 2021047604A1 CN 2020114575 W CN2020114575 W CN 2020114575W WO 2021047604 A1 WO2021047604 A1 WO 2021047604A1
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WIPO (PCT)
Prior art keywords
outer circumference
section
central axis
rod
structure according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/114575
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English (en)
Chinese (zh)
Inventor
沈斌
赵向前
陈奕龙
吴梅周
邱剑滔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Kyd Biomedical Technology Co Ltd
Original Assignee
Shenzhen Kyd Biomedical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Kyd Biomedical Technology Co Ltd filed Critical Shenzhen Kyd Biomedical Technology Co Ltd
Priority to CN202080060864.6A priority Critical patent/CN114401695B/zh
Publication of WO2021047604A1 publication Critical patent/WO2021047604A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements

Definitions

  • the present invention relates to the technical field of implanted medical devices, in particular to an intracavitary implant structure, in particular to a vena cava filter.
  • Implanted medical devices refer to medical devices that can stay in the body for a short or long period of time to support and maintain life, are potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled.
  • Expansible implantable medical devices such as vascular stents, vena cava filters, occluders, and ventricular volume reduction devices can be compressed to a very small volume and implanted into the body cavity through interventional procedures. The compressed devices are released and expanded at the desired position in the body Afterwards, the therapeutic effect is achieved, such as the expansion, support, closure, volume reduction of blood vessels or body cavities, or the prevention of the circulation of thrombus in the blood.
  • the longitudinal axis of the implant should usually be kept at The center of the implanted body cavity, that is, the implant has good neutralization, otherwise it may cause the weakening or loss of the function of the implant.
  • a typical situation is a parachute-shaped vena cava filter, such as Gunther Tulip TM Filter and Celect TM Filter produced and sold by William Cook Company, and related documents such as US5324304A.
  • This type of filter is mainly composed of slender supports arranged or woven to form an umbrella-shaped filter part to block the thrombus in the vein from passing through the filter. At least one end of the slender support is gathered at the center of the umbrella-shaped body, which is usually set to release or recycle The part, such as the recovery hook, is used to release or recover the umbrella-shaped body in cooperation with the sheath.
  • the parachute-shaped vena cava filter lacks an effective limit near the recovery hook, and the probability of the filter tilting is higher when the filter is implanted and during the implantation.
  • Filter tilt is defined as the angle between the longitudinal axis of the filter and the central longitudinal axis of the vena cava> 15°. Severe filter tilt causes the recovery hook to stick to the wall of the inferior vena cava or adhere to it. Serious events such as reduced thrombus filtering effect and perforation. Some literatures indicate that the cause of the filter tilt may be related to factors such as aortic pulsation, gastrointestinal peristalsis, the anatomy of the inferior vena cava itself, and the location of the filter.
  • the rod of the limit mechanism may deflect to its side under pressure and lose the limit effect.
  • the extension space and the compression force of the inner wall of the cavity when the rods in each direction of the limit mechanism are released are different.
  • the limit mechanism on the side of the inner wall of the cavity is close to The rod has a higher probability of lateral deflection.
  • the present invention provides an intracavitary implant structure and a vena cava filter having the structure, which at least has the characteristics of solving or improving one or more of the above-mentioned shortcomings.
  • One aspect of the present invention is to provide an intracavitary implant structure, which includes a central part with a central axis and a functional part with an outer circumference formed by a plurality of rods extending outward from the central part, and the outer circumference of the functional part surrounds the center.
  • the central axis can be compressed.
  • the functional part can at least be used as a positioning structure of the implant.
  • the functional part can be compressed to make it elastic.
  • the implant can be anchored by the elastic force of the functional part in the compressed state that tends to return to the uncompressed state.
  • the central axis can be inclined to be located at the center of the human body lumen, or the functional part can conform to the shape of the human body lumen.
  • At least one rod is provided with a bending part protruding to the outside of the functional part, and is divided into upper and lower branch sections with different angles from the central axis above and below the bending part.
  • the rod is also provided with a side branch section protruding outwards near the bending portion or the bending section. In the non-compressed state, the farthest end of the side branch section from the central axis is located at the end of the lower branch section and the bending section. Between the bends.
  • the side branch section is coplanar with the central axis, and two lower branch sections are led out below the bent portion, and the two lower branch sections are respectively located on both sides of the coplanar surface. .
  • the angle between the extension direction of the upper branch and the central axis is greater than the angle between the extension direction of the lower branch and the central axis.
  • the side branch section includes an upwardly extending arc-shaped curved section, and the deflection angle of the end of the arc-shaped curved section relative to the starting end thereof is greater than 90 degrees.
  • the radius of curvature of the arc-shaped curved section gradually increases toward its end.
  • the side branch section further includes a straight section, and the straight section is substantially parallel to the lower branch section and is led out from the bent portion, and then transitions to the arc-shaped curved section. segment.
  • the number of the lower branch sections is at least two, and they are arranged along the rod width direction with the straight section located between them.
  • the portion of the arc-shaped curved section near the end thereof is substantially parallel to the central axis or approximately parallel to the central axis.
  • the side branch section further includes a tail section, which is led out from the end of the arc-shaped curved section, the tail section points in the direction of the central axis, and the rod width of the tail section is smaller than that of the tail section.
  • the bar width of other parts in the arc-shaped curved section is smaller than that of the tail section.
  • the tail section may have a spherical body or a spherical body-like end with a flanged spherical surface structure.
  • the width of the upper branch section is larger than the widths of the lower branch section and the side branch section respectively, and the arc-shaped curved section of the side branch section includes a parallel section substantially parallel to the central axis, so as to The inner wall of the body cavity forms a pressure contact.
  • the radius of curvature of the arc-shaped curved section gradually increases from its starting end to the end of the pressure contact section.
  • a curved tail section extends in the direction of the central portion, and the width of the tail section is smaller than that of the The width of other sections in the side branch.
  • the change of the width can reduce the resistance of the rod retracting into the sheath or releasing the sheath, and the maneuverability of the implant during release and recovery is improved.
  • the width of the tail section can effectively prevent the side branch from getting stuck in the sheath port when it is retracted into the sheath, because when the implant implanted in the blood vessel is retrieved, the central axis of its central part is almost impossible to match the sheath port. If the central axes of the two coincide with each other, at least some of the side branches must be drawn into the sheath port in an oblique posture, which leads to a high incidence of jamming of the side branches in the sheath port.
  • the intracavitary implant structure may also have one or any combination of the following structural features:
  • the straight section forms an angle with the central axis
  • the arc-shaped curved section has a lowest point in the direction of the central axis, and the lowest point is located between the proximal end and the distal end of the arc-shaped curved section;
  • the deflection angle of the distal end of the arc-shaped curved section relative to the proximal end thereof is not greater than 180 degrees.
  • the deflection angle of the distal end of the side branch segment relative to the proximal end thereof is greater than 180 degrees.
  • the rods constituting the functional part are not fixedly connected.
  • Another aspect of the present invention is to provide a vena cava filter having an intracavitary implant structure as described above.
  • the rods of the functional part are evenly distributed along the circumferential direction, and are used to block thrombus in the vena cava from passing through the functional part.
  • each rod of the functional part leads out two oppositely extending lower branches at the bending part, and in the compressed state, the adjacent rods pass through two adjacent lower branches.
  • the branches abut or cross each other, so that the functional part forms a network structure.
  • the two lower branches can improve the support performance of the outer periphery, and the lower branch and the side branch are staggered, which can reduce the release resistance of the rod.
  • the two inferior branches are not fixedly connected, so that the inferior branches have a greater degree of freedom, so it is easier to withdraw from the endothelial tissue, reducing the damage to the blood vessel, and at the same time, the contact between the two inferior branches can also improve the rod’s
  • the supporting ability and the stability of the shape enable the filter to be more stably maintained at the fixed point release position in the blood vessel according to the required shape, and prevent the filter from migrating.
  • two adjacent lower branch segments between the adjacent rods collide away from their ends.
  • Another aspect of the present invention is to provide another structure of an intracavitary implant or an intracavitary implant having such a structure, comprising a central portion with a central axis and a plurality of strips extending outward from the central portion
  • the rod constitutes a functional part having an outer periphery, and the functional part is compressible.
  • the functional part can at least be used as a positioning structure of the implant.
  • the functional part can be compressed to make it elastic.
  • the implant can be anchored by the elastic force of the functional part in the compressed state that tends to return to the uncompressed state.
  • the central axis can be inclined to be located at the center of the human body lumen, or the functional part can conform to the shape of the human body lumen.
  • the functional part when in a non-compressed state, at least includes a first outer circumference, a second outer circumference, and a second outer circumference formed by the flanges or free ends of a plurality of rods arranged around the central axis.
  • Three outer circumferences, the first outer circumference, the second outer circumference, and the third outer circumference are sequentially arranged outwards from the central portion and are not coplanar with each other, and the first outer circumference and the second outer circumference are compared with the third outer circumference
  • the direction of the central axis is closer to the central part;
  • the flange or free end of the rod can be pressed to move toward the central axis, and the second and third outer circumferences can be pressed to make the implant in the first posture in the cavity where it is implanted Position retention;
  • the implant When any one or more flanges or free ends constituting the first outer periphery are compressed, the implant can be positioned and maintained in the cavity in which it is implanted approaching the first posture.
  • the flange refers to the outer direction of the functional part, so as to provide a possible support site when the implant is in an anchored state.
  • the second outer periphery and the third outer periphery constitute two layers of support sites distributed along the long axis of the cavity for the functional part, which can be in contact with the inner wall of the cavity where the implant body is implanted.
  • the second outer periphery and The third outer periphery is subjected to the pressure of the cavity inner wall, can resist the inclination of the central part or the central axis toward the cavity inner wall, maintain a certain distance between the central part and the cavity inner wall, and form a desired first posture.
  • any one or more rods of the second outer circumference When the supporting function of the flange or free end of any one or more rods of the second outer circumference is lost due to various factors, for example, the flange or free end is offset to its side, and its supporting function is lost or weakened.
  • the flange or free end of the rod on the first outer periphery near the support site can abut against the inner wall of the cavity to form a second posture to resist the inclination of the central part or the central axis to the side of the cavity inner wall where the offset support site is located, Prevent the central part from sticking to the wall, that is, the implant can keep the second posture as close to the first posture as possible.
  • the number of flanges or free ends constituting the first outer circumference is not less than the number of flanges or free ends constituting the second outer circumference, and at least one corresponds to each other.
  • the flange or free end constituting the first outer circumference and the corresponding flange or free end constituting the second outer circumference may be substantially in the same radial direction.
  • the one-to-one corresponding preferred embodiment may refer to a flange or free end constituting the first outer circumference and another flange or free end corresponding to the second outer circumference. The ends are basically in the same radial direction.
  • the first outer circumference is located between the second outer circumference and the third outer circumference along the central axis direction.
  • the second outer circumference is located between the first outer circumference and the third outer circumference in the direction of the central axis.
  • the first outer circumference is formed by the flange of the rod.
  • any outer circumference can be optionally formed by a flange or a free end.
  • the third outer circumference and the second outer circumference are both constituted by the free end, or the third outer circumference is constituted by the free end and the second outer circumference is constituted by the flange.
  • the rods constituting the outer circumference may include at least a first array rod and a second array rod.
  • the third outer circumference is formed by an arrangement of free ends of the first array rods, and the second outer circumference is formed by an array of free ends or flanges of the second array rods.
  • the third outer circumference is formed by the free ends of the first array rods, the first array rod is further provided with branches, and the second outer circumference is arranged by the free ends or flanges of the first array rods. constitute.
  • the first array rod is further provided with a flange, and the first outer circumference is formed by the flange of the first array rod.
  • each of the first array rods has a bending portion, and the first array rod forms an angle at the bending portion at the front and rear sections of the respective bending portions, and the bending portion of the first array rod forms an angle. ⁇ ledges.
  • the free end or the flange where the second outer circumference is formed has a curved section extending in a direction away from the third outer circumference, and the end or protruding end of the curved section constitutes the free end of the second outer circumference. End or flange.
  • the second outer circumference approaches the first outer circumference in a radial direction.
  • the first outer circumference, the second outer circumference and the third outer circumference are all located on the same side of the central part.
  • the flange or the free end has a smooth curved surface, and can contact the inner wall of the cavity into which the implant body is implanted through the smooth curved surface.
  • the number of flanges or free ends constituting the third outer circumference is greater than the number of flanges or free ends constituting the second outer circumference.
  • the number of flanges or free ends constituting the third outer circumference is twice the number of flanges or free ends constituting the second outer circumference, and the number of flanges or free ends constituting the third outer circumference is two by two.
  • Distributed in pairs, each pair of flanges or free ends constituting the third outer circumference and the flanges or free ends constituting the second outer circumference are staggered distributed along the circumferential direction of the central axis.
  • each rod of the functional part is formed by integrally cutting a pipe and then shaping it.
  • Another aspect of the present invention is to provide a vena cava filter having an intracavitary implant structure as described above, and the rods of the functional part are evenly distributed in the circumferential direction to block thrombus in the vena cava from passing through the vena cava filter. Function department.
  • a retrievable intracavitary implant structure or a retrievable intracavitary implant having the structure comprising a central part having a central axis and a plurality of rods extending outward from the central part
  • the functional parts arranged around the central axis can be positioned and maintained in the cavity where the implant body is implanted by compression of the functional part by the cavity inner wall.
  • the functional part can at least be used as a positioning structure of the implant.
  • the functional part can be compressed to make it elastic.
  • the implant can be anchored by the elastic force of the functional part in the compressed state that tends to return to the uncompressed state.
  • the central axis can be inclined to be located at the center of the human body lumen, or the functional part can conform to the shape of the human body lumen.
  • At least one rod includes an arc-shaped curved section, and the arc-shaped curved section gradually increases in radius of curvature from its proximal end close to the central portion to its distal end.
  • the radius of curvature gradually increases, and the more straight the arc-shaped curved section toward its distal end, the smaller the resistance when retracting into the sheath.
  • the distal end of the arc-shaped curved section adjacent to the central axis is substantially parallel to or approximately parallel to the central axis.
  • the rod further has a tail section extending at the distal end of the arc-shaped curved section.
  • the tail section is parallel to the central axis or curved in the direction of the central axis.
  • the end of the rod is a spherical body or a similar spherical body with a flanged spherical surface structure.
  • the rod as a whole has a tendency to reduce the rod width toward its end.
  • the diameter of the end spherical body or similar spherical body of the rod is larger than the rod width of the adjacent section.
  • the rod width of the tail section is smaller than the rod width of the arc-shaped curved section.
  • the rod is further provided with a straight section on the proximal side of the arc-shaped curved section, the rod extends from the straight section to the arc-shaped curved section, and the straight section It forms an angle with the central axis.
  • the arc-shaped curved section has a lowest point in the direction of the central axis, and the lowest point is located between the proximal end and the distal end of the arc-shaped curved section.
  • the deflection angle of the distal end of the arc-shaped curved section relative to the proximal end thereof is greater than 90 degrees.
  • Another aspect of the present invention is to provide a vena cava filter having the aforementioned retrievable intracavitary implant structure.
  • the intracavitary implant structure and the vena cava filter having the structure as a preferred or preferred embodiment of the present invention can have good neutralization, transportability, safety and ease of operation.
  • the intracavitary implant or the vena cava filter can be used as a retrievable device, which can have a longer implantation period, a higher success rate of recovery, and low damage to the vena cava.
  • Figures 1 and 2 are schematic diagrams of a single rod of two embodiments of the implant structure of the present invention
  • 3-9 are schematic diagrams of two symmetrical rods of different implanted body structure embodiments of the present invention.
  • 10-12 are views along the central axis of three embodiments of the implant structure of the present invention.
  • FIG. 13 and 14 are schematic diagrams of different directions of a preferred embodiment of the vena cava filter of the present invention.
  • Fig. 15 is a partial enlarged schematic diagram of Fig. 13;
  • 16 and 17 are respectively two different effect diagrams of a preferred embodiment of a vena cava filter of the present invention after being implanted in the cavity;
  • Figures 18 and 19 are respectively the finite element analysis diagrams of two embodiments of the vena cava filter simulating the force applied after being implanted in the cavity.
  • a type of intracavitary implant structure in the prior art includes a central part with a central axis and a functional part with an outer circumference formed by several rods extending outward from the central part.
  • the outer circumference of the functional part surrounds the central axis and can be covered by the inner wall of the cavity. Compression tends to the central axis, so that the implant is positioned and maintained in the cavity where it is implanted.
  • a typical implant structure of this type can be found in the filter structure disclosed in WO2017186025A1 of the inventor of the present application, and the full text of it is incorporated into this patent.
  • the aforesaid implant in a stronger compressed state has a small shape and volume, so it can be placed in a sheath, and transported through the sheath in the human lumen.
  • the surgeon operates to make the implantation
  • the body is released from the sheath, and the aforementioned implant in the stronger compression state expands and tends to the non-compression state.
  • Its functional part rod expands away from the central axis and presses against the inner wall of the implanted cavity.
  • a plurality of rods form an alignment.
  • the circumferential support of the implant body, at this time, the functional part expands relative to its stronger compression state and maintains it to a weaker compression state so that the implant body is positioned and maintained in the cavity where it is implanted.
  • an object of the present invention is to provide an improved intracavity implant structure.
  • the functional part When in a non-compressed state, the functional part at least includes a first outer periphery 31 and a first outer periphery 31 formed by a plurality of rod flanges or free ends arranged around the central axis.
  • the second outer circumference 32 and the third outer circumference 33, the first outer circumference 31, the second outer circumference 32 and the third outer circumference 33 are arranged in sequence outwards from the central part 1 and are not coplanar with each other.
  • the first outer circumference 31 and the second outer circumference 32 are compared to The third outer circumference 33 is closer to the central portion 1 along the central axis direction;
  • the flange or free end of the rod can be pressed to move to the central axis, and the second outer circumference 32 and the third outer circumference 33 can be pressed to position and maintain the implant in the first posture in the cavity where it is implanted;
  • the implant body When any one or more flanges or free ends constituting the first outer circumference 31 are compressed, the implant body can be positioned and maintained in the first posture in the cavity where it is implanted.
  • the flange faces the outer direction of the functional part.
  • the flange according to the embodiment of the present invention may be the bent portion 211 of the rod, which faces the outer direction of the functional part. Refer to Figs. 1-9, or it may be the most distal end of the arc-shaped bending section from the central axis, refer to Fig. 15.
  • the radius of curvature is the segment of D2.
  • those skilled in the art can also choose other forms of flanges, which can be used as support sites, and contact with the inner wall of the implanted cavity to limit and support the implant.
  • the flange is preferably the bent portion 211 of the rod. Referring to FIGS. 1-9 or 13, the bent portion 211 has a non-arc bend, so that the rod forms a relatively fixed angle above and below the bent portion 211.
  • the compression force can be reduced to be transmitted to the root of the rod, because the angle of the bent portion 211 can be reduced due to the pressure on the end of the rod, which can buffer or reduce the transmission to the root of the rod. force.
  • the lower branch section of the rod drawn below the bent portion 211 provides the end of the rod.
  • the lower branch section has greater elastic restoring force due to the reduced angle of the bent portion 211, thereby providing the implant body Stronger support and positioning in the implant cavity.
  • the segment with a radius of curvature D2 can be a pressure contact segment that is substantially parallel to the central axis or tends to be parallel to the central axis, and can be in pressure contact with the inner wall of the implanted cavity , To form a support or support the positioning of the implant.
  • the radius of curvature of the entire arc-shaped curved section gradually increases from its starting end to the end of the pressure contact section.
  • the inclination is parallel to the central axis, and the angle between the substantially linear pressure contact section and the central axis is not more than 15 degrees.
  • This arrangement not only facilitates the recovery of the pressure contact section into the recovery sheath when the implant is recovered, reduces the recovery resistance to the deformation of the implant caused by the inner wall of the body cavity and the mouth of the recovery sheath, and is also conducive to the implantation state.
  • the pressure contact section provides a larger area of contact with the inner wall of the body cavity and improves the stability of anchoring.
  • each rod of the functional part of the implant in Fig. 12 can be any of the shapes shown in Figs. 7-9, and the shape of each rod of the functional part of the implant in Figs. 10 and 11 can be any of the shapes of Figs. 1-6 .
  • the main difference between Fig. 10 and Fig. 11 is the number and shape of the lower branches of the rod.
  • the second outer periphery 32 and the third outer periphery 33 constitute two layers of support sites distributed along the long axis of the cavity for the functional part, which can be in contact with the inner wall of the cavity where the implant is implanted.
  • the second The outer periphery 32 and the third outer periphery 33 are pressed by the cavity inner wall, can resist the central portion 1 or the inclination of the central axis toward the cavity inner wall, maintain a certain distance between the central portion 1 and the cavity inner wall, and form a desired first posture.
  • any one or more rods of the second outer circumference 32 When the supporting function of the flange or free end of any one or more rods of the second outer circumference 32 is lost due to various factors, for example, the flange or free end is offset to its side, and its supporting function is lost or weakened,
  • the flange or free end of the rod of the first outer periphery 31 near the support site can abut against the inner wall of the cavity to form a second posture, resisting the central portion 1 or the central axis toward the inner wall of the cavity.
  • the inclination of, prevents the central part 1 from sticking to the cavity wall, that is, the implant can keep the second posture as close to the first posture as possible.
  • the implant After the implant is released in the cavity through the sheath, it can directly assume the second posture instead of the first posture.
  • the first posture can be the ideal implant desired by the surgeon.
  • Figures 13 and 14 show a preferred embodiment of an implant of the present invention.
  • the top view along the central axis of the central part 1 is similar to Figure 11, with three outer circumferences.
  • Figures 16 and 17 show the implanted cavity.
  • the posture of the implant shown in Fig. 16 is usually desired.
  • at least one support site of the second outer circumference 32 fails due to lateral offset, and the vicinity of which constitutes the first outer circumference 31
  • the bent portion 211 of the rod functions as a supporting site. This implant posture avoids more excessive inclination of the central portion 1 or the central axis, and maintains an appropriate distance between the central portion 1 and the cavity wall.
  • the number of flanges or free ends constituting the first outer circumference 31 is not less than the number of flanges or free ends constituting the second outer circumference 32, and at least corresponds to one by one.
  • Figures 10 and 11 show a way to correspond in the radial direction of the outer circumference, in which the number of flanges or free ends constituting the first outer circumference 31 and the number of flanges or free ends constituting the second outer circumference 32 are equal, and two The flanges or free ends corresponding to the outer periphery are basically in the same radial direction, which makes the first outer periphery 31 have a better effect of supporting site supplementation, and the supplementary support for the failure site of the second outer periphery 32 is more accurate, and the tilt of the filter The angle can therefore be controlled smaller.
  • FIG. 12 shows another non-radially corresponding way, which is between any two adjacent flanges or free ends of the second outer periphery 32 corresponding to a flange or free end of the first outer periphery 31.
  • the number of flanges or free ends of the first outer circumference 31 in FIGS. 10-12 is equal to the number of flanges or free ends of the second outer circumference 32.
  • the first outer circumference 31 is located between the second outer circumference 32 and the third outer circumference 33 along the central axis direction. Refer to the distribution of the outer circumference radii shown in FIGS. 1 and 2. In other alternative embodiments, the second outer circumference 32 is located between the first outer circumference 31 and the third outer circumference 33 along the central axis direction, as shown in FIG. 5.
  • the third outer circumference 33, the second outer circumference 32, and the first outer circumference 31 may all be formed by free ends of rods, for example, the free ends of the first array rod 2, the second array rod 4, and the third array rod in sequence.
  • the first outer circumference 31 is formed by the flange of the rod
  • the third outer circumference 33 and the second outer circumference 32 are both formed by free ends
  • the third outer circumference 33 is formed by the free end
  • the second outer circumference 32 is formed by the flange .
  • the third outer circumference 33 is composed of the free ends of the first array rods 2
  • the second outer circumference 32 is composed of the free ends or flanges of the second array rods 4.
  • the shape of each rod may be as shown in FIG. 7.
  • the third outer circumference 33 is composed of the free ends of the first array rods 2, the first array rods 2 are also provided with branches, and the second outer circumference 32 is branched by the free ends of the first array rods 2.
  • the shape of the first array rod 2 and its branches can be any of Figs. 1-9.
  • the first array rod 2 may also be provided with a flange, and the first outer circumference 31 is formed by the flange of the first array rod 2.
  • each of the first array rods 2 has a bending portion 211, and the first array rod 2 forms an angle at the bending portion 211 at the front and rear sections of the respective bending portions 211, and the bending portion 211 of the first array rod 2 forms Flange, refer to Figure 1-6.
  • the rod where the free end or flange of the second outer periphery 32 is located has a curved section extending away from the third outer periphery 33, and the end or protruding end of the curved section constitutes the free end or flange of the second outer periphery 32.
  • the first array rod 2 has branches, extending from the upper branch section 21 to the lower branch section 22 and the side branch section 23.
  • the side branch section 23 has a curved section, which can be bent according to the shape of the curved section.
  • the end of the segment serves as a free end to constitute the second outer circumference 32, or the outermost protruding end of the curved segment serves as a flange to constitute the second outer circumference 32.
  • the second outer circumference 32 approaches the first outer circumference 31 in the radial direction. That is, the distance between the first outer circumference 31 and the second outer circumference 32 in the radial direction may be smaller than the distance between the second outer circumference 32 and the third outer circumference 33 in the radial direction.
  • first outer circumference 31 and the second outer circumference 32 are respectively located on two sides of the central portion 1 and the third outer circumference 33 is located on one side of the central portion 1.
  • first outer circumference 31, the second outer circumference 32, and the third outer circumference 33 are all located on the same side of the central portion 1.
  • the flange or the free end has a smooth curved surface, and can contact the inner wall of the cavity where the implant is implanted through the smooth curved surface.
  • the number of flanges or free ends constituting the third outer circumference 33 is greater than the number of flanges or free ends constituting the second outer circumference 32.
  • the first array rod 2 is divided into two lower branch sections 221, 222 from the bending part 211, and the adjacent lower branch sections of two adjacent first array rods 2 can be in contact with each other. But not fixed connection, refer to Figure 12, 16 or 19.
  • the number of flanges or free ends constituting the third outer circumference 33 is twice the number of flanges or free ends constituting the second outer circumference 32, and the flanges or free ends constituting the third outer circumference 33 are distributed in pairs, Each pair of flanges or free ends constituting the third outer circumference 33 and the flanges or free ends constituting the second outer circumference 32 are staggered along the circumferential direction of the central axis, see FIG. 14.
  • the rods of the functional part of the implant of the present invention are preferably formed by integrally cutting the pipes and then shaping them.
  • the pipe material can be a shape memory material such as stainless steel, nickel-titanium alloy, etc., and a design shape in a non-compressed state is obtained through heat setting.
  • At least one rod is provided with a bent part 211 protruding to the outside of the functional part, and is divided into and centered above and below the bent part 211
  • the upper branch section 21 and the lower branch section 22 with different axis angles the rod is also provided with an outwardly extending side branch section 23 near the bending part 211 or the bending part 211. In the non-compressed state, the side branch section 23 is away from the center The most distal end of the axis is located between the end of the lower branch 22 and the bent portion 211.
  • the two figures show two types of rods that constitute the functional part.
  • the distance between the aforementioned most distal end of the side branch 23 and the central axis is b, and the distance between the bending part 211 and the central axis It is c, and the distance from the end of the lower branch 22 to the central axis is a.
  • the side branch section 23 in this embodiment includes an arc-shaped curved section extending upward.
  • the flange formed at the end or the outermost end of the arc-shaped curved section can abut against the inner wall of the implanted cavity in the cavity, and play a supporting role.
  • the rod where the bending part 211 is located is in the implant cavity, and the distal end of the side branch 23 and the end of the lower branch 22 form two supporting sites distributed along the long axis of the cavity to resist the central part.
  • the inclination of the inner wall of the cavity in the direction of the side where the rod is located keeps a certain distance between the central part 1 and the inner wall of the cavity, see the embodiment in FIG. 12.
  • the bent portion 211 of the rod can resist against the inner wall of the cavity and resist the central portion 1.
  • the bent portion 211 and the lower branch 22 can be completely against the inner wall of the cavity, the supporting area of the rod is increased, and the support of the functional part is more stable, but the unit pressure on the inner wall of the cavity is weak, which can avoid crushing or crushing. Stabbing the inner wall of the blood vessel, see the embodiment in Figure 17.
  • the side branch section 23 can be arranged to be led out by the bent portion 211 of the rod, see Figures 1 and 5, the side branch section 23 shown in Figure 1 is an upwardly extending arc-shaped curved section, and the side branch section 23 shown in Figure 5 is a downwardly extending section. Straight section.
  • the side branch 23 is provided near the bent portion 211 of the rod and is led out.
  • the side branch section 23 is led out by the upper branch section 21, see Figures 2 and 4, the side branch section 23 shown in Figure 2 may be an upwardly extending arc-shaped curved section, and the side branch section 23 shown in Figure 4 is a downwardly extending section.
  • the curved section of the arc may be an upwardly extending arc-shaped curved section, and the side branch section 23 shown in Figure 4 is a downwardly extending section.
  • the side branch section 23 may be led out by the lower branch section 22, see FIG. 3 and FIG. 6.
  • the structure and shape of the rod shown in FIG. 6 is a preferred embodiment.
  • the rod has an upper branch 21 leading from the central part 1, and a lower branch 22 leading from the bent part 211.
  • the side branch section 23 is led out from the lower branch section 22 and includes an arc-shaped curved section.
  • the deflection angle of the end of the side branch 23 relative to its starting end is greater than 180 degrees, and its end points to the direction of the central axis.
  • the radius of curvature of the arc-shaped curved section gradually increases toward its end.
  • the arc-shaped curved section in Fig. 15 is composed of three sections.
  • the radius of curvature is D1, D2, and D3, and increases sequentially, so that the side branch section 23 can be as close as possible to the blood vessel wall.
  • the side branch section 23 is drawn near the bent portion 211, and can have a shorter length than that drawn from the central portion 1, so its ability to resist deflection is stronger.
  • the gradual increase in the radius of curvature can make The contact between the side branch segment 23 and the blood vessel wall is line contact instead of point contact.
  • the flange formed at the end or the outermost end of the arc-shaped curved section can abut against the inner wall of the implanted cavity in the cavity, and play a supporting role.
  • the rod where the bent portion 211 is located is implanted in the cavity, and the distal end of the side branch 23 and the end of the lower branch 22 form two supporting sites distributed along the long axis of the cavity to resist the function of the functional portion toward the cavity.
  • the inclination of the inner wall in the direction of the side where the rod is located keeps a certain distance between the central part 1 and the inner wall of the cavity, see the embodiment in FIG. 16.
  • the bent portion 211 of the rod can resist against the inner wall of the cavity, and resist the function of the The inner wall of the cavity is inclined in the direction of the side where the rod is located.
  • the bent portion 211 and the lower branch 22 can be completely against the inner wall of the cavity, the supporting area of the rod is increased, and the support for the functional part is more stable, but the unit pressure on the inner wall of the cavity is weak, which can avoid crushing. Or puncture the inner wall of the blood vessel, see the embodiment in Figure 17.
  • the side branch section 23 also includes a straight section L.
  • the straight section and the lower branch section 22 are basically parallel to each other and are led out by the bending portion 211, and then transition into an arc-shaped curved section.
  • the lower branch 22 can be one, two or more, and those skilled in the art can set it as needed.
  • the side branch section 23 is located between the two lower branch sections 221 and 222, and the straight section and the lower branch section of the side branch section 23 are arranged along the rod width direction.
  • the side branch 23 can be selected to be coplanar or non-coplanar with the central axis. Non-coplanar side branches 23 may be more difficult to release and recover.
  • the side branch section 23 is coplanar with the central axis, and the bent portion 211 of the rod where the side branch section 23 is located leads to a lower branch section 22.
  • the side branch section 23 shown in FIG. 11 is coplanar with the central axis.
  • the bent portion 211 of the rod where the side branch section 23 is located leads to two lower branch sections 221, 222, which are respectively located on both sides of the coplanarity. .
  • the functional part of the implant of Fig. 10 and Fig. 11 is formed by six ends of the lower branch of the first array rod 2 at equal intervals around the central axis to form a third outer circumference 33, and six side branch sections 23 of the first array rod 2
  • the farthest end of the distance from the central axis shown is arranged at equal intervals around the central axis to form a second outer circumference 32, and the bending portions 211 of the six first array rods 2 are arranged at equal intervals around the central axis to form a first outer circumference 31.
  • the functional part of the implant in FIG. 12 is composed of 6 first array rods 2 and 6 second array rods 4 alternately in the circumferential direction.
  • the diameter of the third outer circumference 33 is 1.5-4 times the diameter of the second outer circumference 32, and the second outer circumference 32 approaches the first outer circumference 31 in the radial direction.
  • the upper branch section 21 and the lower branch section 22 may have bends or bends.
  • the lower branch sections 221 and 222 shown in FIGS. 11, 13, and 14 each have an S-shaped curved section.
  • the implant of FIG. 10 has 6 lower branch ends, and the implant of FIG. 11 may have 6 or 12 lower branch ends.
  • the two adjacent rods of the implant of FIG. 8 are opposed to or crossed by two adjacent lower branches, so that the functional part forms a net-like structure, but the 12 ends are still free. End, see Figure 13 and Figure 14.
  • another option is that every two adjacent rods of the implant of Fig. 8 are fixed to one end by two adjacent lower branch segments, so that the implant can have 6 such ends.
  • the embodiment of the present invention preferably, referring to Figs. 1 and 2, the angle ⁇ between the extending direction of the upper branch 21 and the central axis is greater than the angle ⁇ between the extending direction of the lower branch 21 and the central axis.
  • This structure can have a relatively small height (that is, the length along the central axis) under the condition that the maximum outer circumference of the functional part is determined, which is very advantageous in most cases.
  • the width of the rod constituting the functional part is reduced from the central part 1 to the outside as a whole.
  • the width of the upper branch section 21 is greater than that of the lower branch section 22 (or 221, 222) and the side branch section 23.
  • the width of the side branch 23 as a whole decreases from its starting end to its end.
  • the side branch section 23 is divided into two sections with different widths from the bottom of the arc-shaped curved section extending upward.
  • the end of the second half of the narrower width can be provided with a round head similar to a spherical shape, which can avoid puncturing the inner wall of the cavity.
  • the length of the upper branch section 21 is preferably much smaller than the length of the lower branch section 22 (or 221, 222), and the length ratio can be 0.2-0.05.
  • the end of the side branch 23 is located at or near the central portion 1 along the central axis direction.
  • Another aspect of the present invention is to provide a vena cava filter with any of the foregoing intracavitary implant structures, the rods of the functional part are evenly distributed in the circumferential direction, and are used to block the thrombus in the vena cava from passing through the functional part. .
  • Figures 13 and 14 are a preferred vena cava filter provided by the present invention.
  • Each rod of the functional part leads out two oppositely extending lower branches 221 and 222 at the bending part 211.
  • the adjacent rods abut or cross each other through two adjacent lower branches, so that the functional part forms a net-like structure, see Figs. 16, 17 and 19.
  • the side branch section 23 is led out by the bending part 211, and first leads out as a straight section substantially parallel to the lower branch section, and then transitions to an arc-shaped curved section with a gradually increasing radius of curvature.
  • the deflection angle of the tip relative to its starting end is greater than 180 degrees, and its tip points to the direction of the central axis.
  • the side branch section 23 is located between the two lower branch sections 221 and 222, and the straight section of the side branch section 23 and the lower branch section 22 are arranged along the rod width direction.
  • the preferred embodiment of the vena cava filter of the present invention has more excellent structural mechanics, and the overall stress is reduced.
  • Figure 19 shows the preferred embodiment of the vena cava filter of the present invention, the stress at the root (ie the starting end) of the side branch 23 is significantly reduced, and there is no stress concentration area at the root Compared with the comparative example shown in Figure 18, it can significantly reduce the risk of the side branch section 23 breaking at the root, and at the same time, lower stress is conducive to the compression and recovery of the side branch section 23, avoiding forward jumping or reducing the recovery resistance, and operability And security is greatly improved.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une structure d'implant intracavitaire et un filtre de veine cave ayant ladite structure, comprenant une partie centrale (1) ayant un axe central et une partie fonctionnelle ayant une périphérie externe et constituée par une pluralité de tiges (2, 4) s'étendant vers l'extérieur à partir de la partie centrale (1) ; par amélioration de l'agencement, de la structure et de la forme des tiges (2, 4) constituant la partie fonctionnelle, l'implant est amené à avoir un meilleur effet neutralisant.
PCT/CN2020/114575 2019-09-12 2020-09-10 Structure d'implant intracavitaire et filtre de veine cave ayant ladite structure Ceased WO2021047604A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202080060864.6A CN114401695B (zh) 2019-09-12 2020-09-10 一种腔内植入体结构及具有该结构的腔静脉滤器

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
CN201921520236.2 2019-09-12
CN201910864992.5 2019-09-12
CN201921520226 2019-09-12
CN201921520236 2019-09-12
CN201910864991 2019-09-12
CN201910864992 2019-09-12
CN201910864146.3 2019-09-12
CN201921520226.9 2019-09-12
CN201910864991.0 2019-09-12
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Publication number Priority date Publication date Assignee Title
CN217118685U (zh) * 2020-12-25 2022-08-05 深圳市科奕顿生物医疗科技有限公司 一种可植入管腔的滤器

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US20060015137A1 (en) * 2004-07-19 2006-01-19 Wasdyke Joel M Retrievable intravascular filter with bendable anchoring members
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CN104434339A (zh) * 2013-09-25 2015-03-25 傅强 腔静脉滤器
US20170105830A1 (en) * 2015-10-19 2017-04-20 Cook Medical Technologies Llc Biodegradable vascular filter
WO2017186025A1 (fr) * 2016-04-28 2017-11-02 深圳市科奕顿生物医疗科技有限公司 Filtre de veine cave inférieure

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US5324304A (en) * 1992-06-18 1994-06-28 William Cook Europe A/S Introduction catheter set for a collapsible self-expandable implant
US8500774B2 (en) * 2004-01-22 2013-08-06 Rex Medical, L.P. Vein filter
MX2007013932A (es) * 2005-05-12 2008-01-28 Bard Inc C R Filtro de coagulo de sangre removible.
CA2633859A1 (fr) * 2005-12-30 2007-07-12 C.R. Bard Inc. Filtre amovible pour caillot sanguin a bord permettant de couper a travers l'endothelium
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Publication number Priority date Publication date Assignee Title
CN2394594Y (zh) * 1999-10-14 2000-09-06 徐克� 支架型滤过器
US20060015137A1 (en) * 2004-07-19 2006-01-19 Wasdyke Joel M Retrievable intravascular filter with bendable anchoring members
US20140107695A1 (en) * 2005-05-12 2014-04-17 C. R. Bard, Inc. Tubular Filter
CN104434339A (zh) * 2013-09-25 2015-03-25 傅强 腔静脉滤器
CN104352287A (zh) * 2014-10-13 2015-02-18 陈奕龙 腔静脉过滤器
US20170105830A1 (en) * 2015-10-19 2017-04-20 Cook Medical Technologies Llc Biodegradable vascular filter
WO2017186025A1 (fr) * 2016-04-28 2017-11-02 深圳市科奕顿生物医疗科技有限公司 Filtre de veine cave inférieure

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CN214180704U (zh) 2021-09-14
CN112120828A (zh) 2020-12-25
CN112120828B (zh) 2025-05-02
CN214180705U (zh) 2021-09-14
CN114401695A (zh) 2022-04-26
CN214511417U (zh) 2021-10-29
CN114401695B (zh) 2025-04-04

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