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WO2019227859A1 - Support structure, prosthesis, and prosthesis system - Google Patents

Support structure, prosthesis, and prosthesis system Download PDF

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Publication number
WO2019227859A1
WO2019227859A1 PCT/CN2018/114424 CN2018114424W WO2019227859A1 WO 2019227859 A1 WO2019227859 A1 WO 2019227859A1 CN 2018114424 W CN2018114424 W CN 2018114424W WO 2019227859 A1 WO2019227859 A1 WO 2019227859A1
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WO
WIPO (PCT)
Prior art keywords
brim
structures
support structure
prosthesis
extension
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/CN2018/114424
Other languages
French (fr)
Chinese (zh)
Inventor
张劼
陈齐欧
张立争
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.)
Shanghai Microport Medical Group Co Ltd
Original Assignee
Shanghai Microport Medical Group 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 Shanghai Microport Medical Group Co Ltd filed Critical Shanghai Microport Medical Group Co Ltd
Publication of WO2019227859A1 publication Critical patent/WO2019227859A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2/2814Bone stump caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2/2846Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • A61F2002/30566Helical springs

Definitions

  • the invention relates to the technical field of medical devices, and in particular, to a support structure, a prosthesis, and a prosthesis system.
  • patent application CN107518961A discloses a magnetothermal prolongable prosthesis, which includes a magnetic generating control device for controlling the magnetic generating device to generate an alternating magnetic field.
  • a magnetothermal prolongable prosthesis which includes a magnetic generating control device for controlling the magnetic generating device to generate an alternating magnetic field.
  • the boss of the support tube heats up and melts the limit structure, and furthermore, the support tube moves relative to the limit structure by the elastic force of the compression spring, thereby achieving the effect of non-contact extension.
  • the object of the present invention is to provide a support structure, a prosthesis, and a prosthesis system to solve one or more of the problems of insufficient support force of the existing prosthesis and failure of the extension function of the spring.
  • a support structure for supporting a prosthesis, including an extension member and a blocking member;
  • the extension member includes a body and a plurality of brim structures located at a proximal end of the body; each of the brim structures extends radially outwardly of the body to extend into a limiting piece, and a plurality of the brim
  • the structure is also arranged along the axial direction of the body;
  • the body has an inner cavity closed at the distal end, and the body is provided with a hollow structure at a position adjacent to a plurality of the brim structures;
  • the blocking member is a hollow structure with open ends and is disposed in the inner cavity, For covering the hollow structure;
  • a prosthesis including a shell, a limiting member, an elastic member and the supporting structure, wherein:
  • the housing has a first open end at a distal end and a first closed end at a proximal end;
  • the limiting member is accommodated in the casing, and is configured to be at least axially relatively stationary with the casing;
  • the extension of the support structure is accommodated in the limiting member, and extends to the distal end of the housing, and is configured to remain relatively stationary at least circumferentially with the housing, and the extension of A plurality of the brim structures project into the limiting member;
  • the elastic member is partially accommodated in the inner cavity of the extension member, and one end of the elastic member extends to a distal end portion of the inner cavity, and the other end is from a proximal end portion of the inner cavity. Extending out to the proximal end of the housing or the stopper;
  • a prosthesis system including the prosthesis and an alternating magnetic field generating device, the alternating magnetic field generating device is configured to provide an alternating magnetic field, and The eaves structure generates heat under the action of a magnetic field.
  • the brim structure has a tip portion to extend into the limiting member, the tip portion has a first included angle, and the first included angle is between 30 ° and 60 °.
  • the first included angle is 45 °.
  • the first included angle is defined by a side edge of the brim structure and a bottom edge, the bottom edge extends in a radial direction of the body, and the bottom edge and an axial direction of the body A second included angle is formed, and the second included angle is between 80 ° and 110 °.
  • the second included angle is 90 °.
  • the maximum diameter of one of the brim structures closest to the proximal end of the body is larger than the maximum diameter of the other brim structures.
  • the maximum diameter of one of the brim structures closest to the proximal end of the body is 1.05 times the maximum diameter of the other brim structures.
  • a plurality of the brim structures are connected end to end along the axial direction.
  • a plurality of the brim structures are arranged at intervals in the axial direction.
  • the hollowed-out structure includes a plurality of hollowed-out structures, wherein a part of the hollowed-out structures is located at least partially between adjacent hat brim structures.
  • the body includes a connection portion, a support portion, and a heating portion in order from the distal end to the proximal end; the connection portion is used to connect an external member, and the inner cavity extends axially from the proximal end of the heating portion to The distal end of the support portion, wherein a plurality of the brim structures are disposed outside the heating portion, and the floor structure is located on an area of the heating portion adjacent to the support portion.
  • the supporting structure further includes a prism member, a cross section of the prism member is polygonal, and the prism member is located at the connecting portion and / or the supporting portion.
  • the inner cavity includes a reserved space segment, the inner diameter of the reserved space segment is greater than the inner diameter of the rest of the inner cavity, the blocking member is located in the reserved space segment, and the blocking The outer diameter of the piece matches the inner diameter of the reserved space segment.
  • the number of cap structures is 2-8.
  • the limiting member is a hollow structure with two ends open.
  • the support structure, prosthesis, and prosthesis system provided by the present invention, by providing a plurality of cap structures at the proximal end of the extension of the support structure, and adding a blocking member in the inner cavity of the extension, the said A part of the material of the prosthesis restraint piece cut by the brim structure will not overflow into the inner cavity of the extension member for placing the elastic member, and can instead overflow between the brim structures, thereby increasing the strength of the brim structure, Improve the structural support of the prosthesis, while ensuring that the extension function of the prosthesis is stable and effective.
  • the brim structure has a tip portion protruding into the stopper, and a first included angle of the tip portion is between 30 ° and 60 °, and more preferably 45 °, within these angle ranges.
  • the inner brim structure can provide better structural support, and can also ensure smooth movement of the extension.
  • FIG. 1 is an exploded schematic view of a prosthesis according to an embodiment of the present invention
  • FIG. 2 is a schematic structural diagram of an extension piece according to an embodiment of the present invention.
  • FIG 3 is an assembly diagram of an extension member and an elastic member according to an embodiment of the present invention.
  • FIG. 4 is a schematic axial sectional view of an extension member according to an embodiment of the present invention.
  • FIG. 5 is a perspective view of a proximal end of an extension piece according to an embodiment of the present invention.
  • FIG. 6 is a schematic diagram of a stress of an extension member cooperating with a limit member and an external force under an embodiment of the present invention
  • FIG. 7 is a schematic view of a force of an extension member cooperating with a limiting member and under an external force according to another embodiment of the present invention.
  • FIG. 8 is a drawing of a raw material stretching curve of a stopper according to an embodiment of the present invention.
  • Limiting piece-1 supporting structure-2; extension piece-21; blocking piece-22; elastic piece-3; connecting portion-211; supporting portion-212; heating portion-213; connecting hole-2111; inner cavity-2112 Hollow structure-2113; Hat eaves structure-2114; Reserved space section-2115; Pin hole-2116; Cutting tube section -1001; Material stacking tube section -1002.
  • distal and distal refer to the extensible side of the prosthesis; correspondingly, “proximal” and “proximal” are opposite to “distal” and “distal” The side.
  • the core idea of the present invention is to provide a support structure, a prosthesis and a prosthesis system, so as to solve the problems of insufficient support force of the existing prosthesis extension, failure of the spring extension function and the like.
  • the present invention provides a support structure, the support structure includes an extension member and a blocking member;
  • the extension member includes a body and a plurality of brim structures at a proximal end of the body; a plurality of the brim
  • the structure extends outward in the radial direction of the body to extend into a limiting piece, and a plurality of the brim structures are also arranged along the axial direction of the body;
  • the body has an inner cavity closed at the distal end, and
  • the body is provided with a hollow structure at a position adjacent to a plurality of the hat eaves structures;
  • the blocking member is a hollow structure with open ends and is disposed in the inner cavity to cover the hollow structure; wherein: when a plurality of When the brim structure heats up, the positions where the stopper is in contact with a plurality of the brim structure are melted to release the stopper from restricting the support structure.
  • the present invention also provides a prosthesis including the supporting structure, and the prosthesis further includes a shell, a limiting member, and an elastic member, wherein the shell has a first open end portion at a distal end and a proximal portion The first closed end of the end; the limiting member is accommodated in the housing, and is configured to maintain at least axial relative static with the housing; the extension of the support structure is accommodated in the housing In the stopper, extending to the distal end of the housing, and configured to maintain at least a relative circumferential staticness with the housing, and a plurality of the brim structures of the extension member project into the stopper;
  • the elastic member is partially accommodated in the inner cavity of the extension member, that is, one end of the elastic member extends to a distal end portion of the inner cavity, and the other end passes through the blocking member from the inner portion.
  • the proximal end of the cavity extends out to the proximal end of the housing or the limiter; when an alternating magnetic field is applied to the outside of the housing, a plurality of the brim structures heat up, causing the limit The parts contacting a plurality of the brim structures are melted, so that the elastic parts are Pushing force of the extension member along the axial direction of the stopper member, moves toward the distal end of the housing.
  • the present invention also provides a prosthesis system including the prosthesis and an alternating magnetic field generating device, the alternating magnetic field generating device is configured to provide the alternating magnetic field, that is, an alternating The variable magnetic field is generated by an alternating magnetic field generating device, which is a trigger for prosthesis extension of the present invention.
  • an eddy current is formed at the brim structure of the extension member under the action of the alternating magnetic field, and the heat generated by the eddy current makes the limiting member contact a plurality of the brim structures
  • the melting of the part reduces the limiting effect of the limiting member on the supporting structure.
  • the supporting structure is moved by the elastic member along the axial direction of the prosthesis to the distal end of the shell, that is, toward the false Extension outside the body.
  • the prosthesis system of the present invention has a simple design structure, can provide higher support force during daily use, and has high reliability.
  • an embodiment of the present invention provides a prosthesis.
  • the prosthesis includes a shell, a limiting member 1, a supporting structure 2, and an elastic member 3.
  • the supporting structure 2 includes an extension member 21 and a blocking member 22.
  • the casing is not shown in the drawings, but those skilled in the art should be able to know how to implement the structure of the casing according to the prior art.
  • the limiter 1 is housed in the housing and is configured to maintain at least axial relative static with the housing.
  • the limiter 1 is used to limit the support structure 2; the limiter
  • the material of 1 is preferably a resin, more preferably a polyacetal resin, at least the distal end of the stopper 1 is open (preferably both ends are open), the support structure 2 is accommodated in the stopper 1, and
  • the extension piece 21 extends to the outside of the distal end of the housing. Further, the extension piece 21 is configured to remain relatively stationary with the housing in the circumferential direction, so that the extension piece 21 cannot rotate at will relative to the housing.
  • an embodiment of the present invention provides a support structure 2.
  • the support structure 2 includes the extension member 21 and a blocking member 22.
  • the extension member 21 includes a main body and a proximal end provided on the main body.
  • a plurality of brim structures 2114 are arranged along an axial direction of the body. Wherein, any one of the brim structures 2114 extends outward in the radial direction of the body and projects into the limiting member 1.
  • the “radial extension” here cannot be narrowly considered that the brim structure 2114 can only extend in a direction perpendicular to the axial direction of the body, but it should be broadly understood that the brim structure does not extend in the axial direction of the body.
  • the extension piece 21 is an axially movable part relative to the shell. The extension piece 21 is used to release the restriction member 1 from the restriction by the heat generated by the plurality of brim structures 2114 to achieve the extension of the prosthesis.
  • the body of the extension piece 21 has a closed inner cavity 2112 (which is an internal structure, and is shown by dashed lines in FIGS. 2 and 3), and the body of the extension piece 21 is adjacent to a plurality of the brim
  • a hollow structure 2113 is also provided at the part of the structure 2114 to prevent the body part from heating under the action of an alternating magnetic field.
  • the blocking member 22 is located in the inner cavity 2112 to cover all the hollow structures 2113 on the body, and can prevent the hot-melt material generated by the heating of the stopper 1 from flowing into the inner cavity 2112 through the hollow structure 2113. Promote the hot-melt material to stay between the brim structures 2114, and provide sufficient support for the daily use of the prosthesis after condensation.
  • the blocking member 22 is also a hollow structure with open ends to allow the elastic member 3 to pass through.
  • the proximal end of the inner cavity 2112 of the extension member 21 is open but the distal end is closed, that is, the inner cavity 2112 is a blind hole extending from the proximal end to the distal end of the body. structure.
  • the elastic member 3 is partially accommodated in the inner cavity 2112, that is, one end of the elastic member 3 extends to the distal end of the inner cavity 2112, and the other end passes through the blocking member 22 from the inner cavity.
  • the proximal end portion of 2112 extends out and further extends to the proximal end portion of the housing, wherein the portion of the elastic member 3 in the extension member 21 is shown by dashed lines in the figure.
  • the limiting member 1 may be a hollow structure with two ends open to allow the elastic member 3 to pass through its proximal end and connect with the shell.
  • the limiting member 1 may be a hollow structure with a closed proximal end, and the proximal end of the elastic member 3 is connected to the closed end of the limiting member 1.
  • the elastic member 3 is configured to provide an elastic force to the extension member 21, and a direction of the elastic force is directed to a distal end of the extension member 21.
  • the elastic member 3 generally uses a spring, such as a spring made of a cobalt-chromium alloy material, and the length of the spring is not specifically limited, so as to provide sufficient elastic force.
  • the inventor has found that due to the complex movements of the human body, the forces on the support structure 2 are also relatively complicated.
  • the limit member 1 pairs the support structure.
  • the stopper 1 at this time obviously provides a supporting force to the supporting structure 2.
  • FIG. 7 when the force F1 exerted on the support structure 2 by the outside of the prosthesis is smaller than the elastic force F2 provided by the elastic member 3 on the support structure 2, the limit member 1 affects the support structure 2.
  • the stopper 1 provides a blocking force to the support structure 2. Therefore, according to the magnitude of the acting force F1 exerted on the support structure 2 by the outside of the prosthesis, the limiter 1 can provide the supporting structure 2 with a supporting force in the same direction as the elastic force F2 or the elastic force F2. The blocking force in the opposite direction. It should be understood that the force provided by the limiter 1 on the support structure 2 refers to the force exerted by the limiter 1 on the brim structure 2114 on the extension member 21.
  • the prosthesis when the prosthesis is extended, the patient lies flat on the surgical bed, and F1 can be approximately zero due to the limbs lying flat.
  • an alternating magnetic field is applied to the brim structure 2114, and the stopper 1 corresponds to the brim structure At 2114, it becomes soft due to heat, so that the force F3 'exerted by the limiter 1 on the extension member 21 becomes smaller, thereby facilitating the elastic force to overcome the blockage of the limiter 1, and finally the extension member 21 in the elastic member 3
  • the elastic force F2 moves relative to the limiting member 1.
  • the cap structure 2114 cuts the stopper 1 that is softened due to heat, thereby forming the cut pipe portion 1001 on the stopper 1.
  • a part of the hot-melt material generated by the thermal melting of the limiter will overflow into the space between the extension and the limiter, and a part will flow into the inner cavity of the extension through the hollow structure and condense on the elastic member. , Affecting the expansion and contraction of the elastic member.
  • the inventor also found that in the traditional prosthesis, when the prosthesis is extended, the supporting force exerted by the stopper 1 on the brim structure 2114 on the extension 21 is mainly provided by the cut tube portion 1001. achieve.
  • there is usually only one brim structure on the extension member so that the support provided by the cut pipe portion of the stopper to the brim structure is insufficient.
  • the present invention overcomes the above-mentioned defects by providing a plurality of cap structures 2114 along the axial direction on the body of the limiting member 1 and a blocking member 22 covering the hollow structure 2113 in the inner cavity 2112. Specifically, during the extension of the prosthesis, due to the role of the blocking member 22, the penetration of the hot-melt material into the inner cavity 2112 through the hollow structure 2113 is avoided, and the hot-melt material will in turn overflow into the material formed between the brim structures 2114 Stacked tube section 1002.
  • This part of the material stacking pipe portion 1002 will provide the supporting force to the brim structure 2114 after condensing, and combined with the supporting force provided by the cut pipe portion 1001, the two will jointly increase the supporting force of the supporting structure 2 to solve a single brim structure The problem of insufficient support.
  • the hot melt material can also be prevented from flowing into the inner cavity 2112 of the extension member 21 through the hollow structure 2113 to condense on the elastic member, ensuring the normal expansion and contraction of the elastic member 3, and ensuring the extension of the prosthesis.
  • the material of the blocking member 22 is preferably a heat-resistant material, so as to prevent the blocking member 22 from being melted or softened by heat and affecting its use.
  • a reserved space section 2115 is provided at the proximal end of the inner cavity 2112, and the inner diameter of the reserved space section 2115 is larger than the inner diameter of the rest of the inner cavity 2112.
  • the inner diameter of the reserved space segment 2115 matches the outer diameter of the blocking member 22 (such as an interference fit) to accommodate the blocking member 22.
  • the inner diameter of the blocking member 22 allows the elastic member 3 to pass through and freely expand and contract with respect to it.
  • the axial length of the reserved space segment 2115 and the blocking member 22 is sufficiently long so that the blocking member 22 can cover all the hollow structures 2113.
  • the axial length of the reserved space segment 2115 may be equal to the axial length of the heating portion 213 described below, but is not limited thereto, and is specifically determined according to the axial range in which the hollow structure 2113 is arranged.
  • the body of the extension member 21 includes a connecting portion 211, a supporting portion 212, and a heating portion 213 in order from the distal end to the proximal end, that is, the AB segment corresponds to the connecting portion 211, BC The segment corresponds to the support portion 212, and the CD segment corresponds to the heating portion 213.
  • the connection portion 211 is used to connect external components (such as femoral embedding segments), for example, as shown in FIG. 2 and FIG.
  • connection portion 211 is connected to the external component through a blind hole-type connection hole 2111, and the connection here
  • the hole 2111 is also an internal structure and is shown by a dotted line in the figure.
  • the connecting portion 211 is also provided with a pin hole 2116 (the invisible portion is shown by a dotted line) penetrating perpendicularly to the connecting hole 2111.
  • a pin is provided to fix the extension piece 21 to prevent the extension piece 21 from moving relative to an external member;
  • the inner cavity 2112 runs through the support portion 212 and the heating portion 213, that is, the proximal end of the inner cavity 2112 from the heating portion 213 axially Extending to the distal end of the support portion 212, which is the proximal end of the connection portion 211;
  • the brim structure 2114 is located on the outer periphery of the heating portion 213, and the hollow structure 2113 is located on the heating portion An area on 213 adjacent to the support portion 212.
  • the support structure 2 further includes a prism member, specifically, the body of the extension member 21 further includes the prism member, and the cross section of the prism member is polygonal, preferably Regular polygon.
  • the prism member is located on at least one of the support portion 212 and the connection portion 211, that is, a cross-sectional (radial cross-section) shape of at least a portion of the body is configured into a prism shape.
  • the angular number of the prism shape here can be any natural number greater than 2, such as a triangle, a quadrangle, a pentagon, a hexagon, and the like.
  • the outer shell also has a partial cross-sectional shape that matches the shape of the prism member, so as to prevent the extension member 21 from rotating randomly relative to the outer shell.
  • a plurality of the brim structures 2114 may be closely connected, that is, the head and tail are continuously arranged, and the heads and tails may be spaced apart, or further, as shown in FIGS. 4 and 5, a hollow structure 2113 may be provided between adjacent brim structures 2114.
  • the hollow structures 2113 may be provided in the intervals between all the brim structures 2114, or the hollow structures 2113 may be provided in the intervals between a part of the brim structures.
  • the arrangement of the hollow structure can effectively isolate the body, so that the brim structure generates heat, but the body does not generate heat, so that the heating of the limiter 1 is more concentrated.
  • the number of cap structures 2114 is preferably two to eight, and more preferably two.
  • the brim structure 2114 can smoothly move to the target position, and at the same time, there can be sufficient contact between the stopper 1 and the brim structure 2114 to achieve the limit
  • the supporting effect of the piece 1 on the brim structure 2114 and the pressure of the elastic member 3 are shared.
  • the shape of the longitudinal section (axial section) of the brim structure 2114 is designed as a polygon, and more preferably a quadrangle. Viewed from the angle shown in FIG. 4, the longitudinal cross-sectional shape (one side) of the brim structure 2114 is trapezoidal, preferably a right-angled trapezoid, but is not limited to a trapezoid, as long as it is a polygon.
  • the brim structure 2114 has a tip portion to extend into the limiting member 1.
  • the tip portion has a first included angle ⁇ , and the first included angle ⁇ is preferably between 30 ° and 60 °, and more preferably 45 °. At this time, it can provide better support and ensure smooth movement of the extension member.
  • the first included angle ⁇ may be defined by a side edge and a bottom edge of the brim structure 2114, and the side edge is located at a distal end of the bottom edge, that is, the side edge is from the distal end toward the proximal end. Extending outward. The bottom edge extends substantially along the radial direction of the body.
  • the "radial extension" here also needs to be understood from a broad perspective, that is, the bottom edge does not necessarily extend strictly perpendicular to the axial direction. As long as it does not extend in the axial direction.
  • a second included angle ⁇ is formed between the bottom edge and the axial direction of the body, the second included angle is used to define a radial extension direction of the brim structure, and the second included angle ⁇ is preferably at It is between 80 ° and 110 °, and more preferably 90 °.
  • the largest diameter of the brim structure 2114 closest to the proximal end of the body is preferably larger than the maximum diameter of the other brim structures, for example, about 1.05 times the maximum diameter of the other brim structures, in the prosthesis During the extension, the large diameter of a brim structure near the proximal end of the extension 21 can be used to further block the flow of the hot melt material to the proximal end, so that more material stacking tube portions 1002 can be obtained between the brim structure and the support structure 2 Can get enough support.
  • a tensile curve of a raw material for preparing a stopper wherein the raw material for the preparation is polyacetal material (POM), the abscissa is strain (%), and the ordinate is stress (MPa).
  • the corresponding test temperature from top to bottom is -40 ° C, 23 ° C, 40 ° C, 60 ° C, 80 ° C. It can be seen from the figure that the limiting stress value of the polyacetal material is about 60Mpa at a room temperature of 23 ° C (the test method is based on the standard GB / T 22271.2-2008).
  • the relationship between the load of the prolongable prosthesis with a single brim structure in the prior art CN107518961A and the extendable prosthesis with a double brim structure of the present invention and the stress resistance of the limiter 1 is shown in the following table (test The method is based on the standard GB / T7314-2017), in which the longitudinal section shapes of the brim structure 2114 of the prior art and the present invention are right-angled trapezoids, the first included angle ⁇ is 45 °, and the second included angle ⁇ is 90 ° The maximum outer diameter of the brim structure 2114 is 19 mm.
  • the load that the prolongable prosthesis in this embodiment can withstand is 2-3 times that of the prior art. Therefore, the extendable prosthesis of the present invention can provide sufficient support.
  • the support structure 2 includes the extension member 21 and the blocking member 22.
  • the extension piece 21 includes a main body and a plurality of hat eaves structures 2114 located at the proximal end of the body. The plurality of hat eaves structures extend outward in the radial direction of the body and extend into the stopper 1 so that the stopper 1 and the extension 21 It is fixed under normal circumstances and will not produce axial relative movement.
  • an alternating magnetic field is applied to the prosthesis, and the brim structure generates heat to melt the stopper 1 in contact with the prosthesis. Then, under the action of elastic force, the extension 21 moves to the distal end, and the The extension member 21 is provided with a plurality of brim structures 2114 and a blocking member 22 is provided in the inner cavity 2112 to cover the hollow structure 2113, so that the material left by the cutting on the stopper 1 enters between the brim structures 2114 to increase support.
  • the supporting force of the structure 2 prevents the material from overflowing into the inner cavity 2112 through the hollow structure 2113, and affects the expansion and contraction of the elastic member 3.
  • the above embodiments have described in detail the different configurations of the support structure, the prosthesis, and the prosthesis system.
  • the present invention includes, but is not limited to, the configurations listed in the above embodiments. Any of the configurations provided in the above embodiments The content that is transformed on the basis of the model belongs to the scope protected by the present invention. Those skilled in the art can learn from the contents of the above embodiments.

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  • Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (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

A support structure, a prosthesis, and a prosthesis system, to enhance the support strength of a prosthesis and ensure a stable and effective extension function of the prosthesis. The support structure comprises an extending member (21) and a blocking member (22). The extending member (21) comprises a body and a plurality of brim structures (2114) at a proximal end of the body. The plurality of brim structures (2114) extend outwards in a radial direction of the body into a limiting member (1), and the plurality of brim structures (2114) are also arranged in an axial direction of the body. The body has an inner cavity (2112) closed at one end, and the body is provided with a hollow structure (2113) at a position adjacent to the plurality of brim structures (2114). The blocking member (22) is a hollow structure open at both ends and is disposed in the inner cavity (2112) to cover the hollow structure (2113). When the plurality of brim structures (2114) generate heat, part of the limiting member (1) in contact with the plurality of brim structures (2114) softens, so as to eliminate the limiting of the limiting member (1) on the support structure.

Description

支撑结构、假体以及假体系统Support structure, prosthesis and prosthesis system 技术领域Technical field

本发明涉及医疗器械技术领域,特别涉及一种支撑结构、假体以及假体系统。The invention relates to the technical field of medical devices, and in particular, to a support structure, a prosthesis, and a prosthesis system.

背景技术Background technique

近几年,可延长假体在保肢技术中得到了广泛应用,尤其是儿童恶性骨肿瘤保肢技术,其可以避免二次手术,有效减少给患者带来的二次创伤,从而获得良好的临床疗效。In recent years, prolongable prosthesis has been widely used in limb salvage technology, especially in children with malignant bone tumor limb salvage technology, which can avoid secondary surgery and effectively reduce secondary trauma to patients, thus obtaining good Clinical efficacy.

目前提供了多种可延长假体的结构,例如专利申请CN107518961A公开了一种磁热型可延长假体,其包括磁发生控制装置,用于控制磁发生装置产生交变磁场,在交变磁场的作用下,支撑管的凸台发热,并融化限位结构,进而在压缩弹簧的弹性力推动之下,支撑管相对限位结构移动,从而达到非接触式延长的效果。然而,目前在临床应用上,磁热型可延长假体存在着由于支撑力不足导致的支撑结构错位的问题。此外,磁热过程中,一旦热熔材料流入压缩弹簧所在支撑管腔体中,还可导致压缩弹簧延长功能失效。类似的可延长假体结构还可见于专利US2003/0032958A1中,然而该专利也存在与CN107518961A相同的问题。At present, a variety of prolongable prosthesis structures are provided. For example, patent application CN107518961A discloses a magnetothermal prolongable prosthesis, which includes a magnetic generating control device for controlling the magnetic generating device to generate an alternating magnetic field. Under the action of the support, the boss of the support tube heats up and melts the limit structure, and furthermore, the support tube moves relative to the limit structure by the elastic force of the compression spring, thereby achieving the effect of non-contact extension. However, currently in clinical applications, there is a problem of misalignment of the support structure due to insufficient support force of the magnetothermal prolongable prosthesis. In addition, during the magnetic heating process, once the hot-melt material flows into the support tube cavity where the compression spring is located, the extension function of the compression spring may also be invalidated. A similar prolongable prosthesis structure can also be found in patent US2003 / 0032958A1, however this patent also has the same problems as CN107518961A.

发明内容Summary of the Invention

有鉴于此,本发明的目的在于提供一种支撑结构、假体以及假体系统,以解决现有的假体支撑力不足、弹簧延长功能失效等问题中的一个或多个。In view of this, the object of the present invention is to provide a support structure, a prosthesis, and a prosthesis system to solve one or more of the problems of insufficient support force of the existing prosthesis and failure of the extension function of the spring.

根据本发明的一个方面,提供了一种支撑结构,用于假体的支撑,包括延长件和阻挡件;According to one aspect of the present invention, a support structure is provided for supporting a prosthesis, including an extension member and a blocking member;

所述延长件包括本体和位于所述本体之近端的多个帽檐结构;每个所述帽檐结构沿所述本体径向向外延伸,以伸入一限位件,且多个所述帽檐结构还沿所述本体的轴向排布;The extension member includes a body and a plurality of brim structures located at a proximal end of the body; each of the brim structures extends radially outwardly of the body to extend into a limiting piece, and a plurality of the brim The structure is also arranged along the axial direction of the body;

所述本体具有远端封闭的内腔,且所述本体在邻近多个所述帽檐结构的部 位设有镂空结构;所述阻挡件为两端开放的中空结构并设置于所述内腔中,用以覆盖所述镂空结构;The body has an inner cavity closed at the distal end, and the body is provided with a hollow structure at a position adjacent to a plurality of the brim structures; the blocking member is a hollow structure with open ends and is disposed in the inner cavity, For covering the hollow structure;

其中:当多个所述帽檐结构发热时,所述限位件与多个所述帽檐结构相接触的部位融化,以解除所述限位件对所述支撑结构的限位。Wherein, when a plurality of the brim structures are heated, the contact portions of the stopper with the plurality of brim structures are melted, so as to release the stoppers from restricting the support structure.

进一步,根据本发明的另一个方面,提供了一种假体,包括外壳、限位件、弹性件和所述的支撑结构,其中:Further, according to another aspect of the present invention, a prosthesis is provided, including a shell, a limiting member, an elastic member and the supporting structure, wherein:

所述外壳具有位于远端的第一开口端部和位于近端的第一封闭端部;The housing has a first open end at a distal end and a first closed end at a proximal end;

所述限位件容置于所述外壳中,并被配置为与所述外壳至少保持轴向相对静止;The limiting member is accommodated in the casing, and is configured to be at least axially relatively stationary with the casing;

所述支撑结构的所述延长件容置于所述限位件中,并向所述外壳的远端延伸,并被配置为与所述外壳至少保持周向相对静止,且所述延长件的多个所述帽檐结构伸入所述限位件;The extension of the support structure is accommodated in the limiting member, and extends to the distal end of the housing, and is configured to remain relatively stationary at least circumferentially with the housing, and the extension of A plurality of the brim structures project into the limiting member;

所述弹性件部分容置于所述延长件的所述内腔中,且所述弹性件的一端延伸至所述内腔的远端端部,另一端从所述内腔的近端端部延伸出并延伸至所述外壳或所述限位件的近端端部;The elastic member is partially accommodated in the inner cavity of the extension member, and one end of the elastic member extends to a distal end portion of the inner cavity, and the other end is from a proximal end portion of the inner cavity. Extending out to the proximal end of the housing or the stopper;

当所述外壳的外侧施加一交变磁场时,多个所述帽檐结构发热,使所述限位件与多个所述帽檐结构相接触的部位融化,以使所述弹性件以弹性力推动所述延长件沿所述限位件的轴向,向所述外壳的远端移动。When an alternating magnetic field is applied to the outer side of the shell, a plurality of the brim structures heat up, and the portions where the stopper contacts the plurality of brim structures are melted, so that the elastic member is pushed by the elastic force. The extension piece moves to the distal end of the casing along the axial direction of the limiting piece.

进一步,根据本发明的又一个方面,提供了一种假体系统,包括所述的假体和交变磁场发生装置,所述交变磁场发生装置用于提供交变磁场,在所述交变磁场作用下所述帽檐结构发热。Further, according to another aspect of the present invention, there is provided a prosthesis system including the prosthesis and an alternating magnetic field generating device, the alternating magnetic field generating device is configured to provide an alternating magnetic field, and The eaves structure generates heat under the action of a magnetic field.

优选的,所述帽檐结构具有一尖端部以伸入所述限位件,所述尖端部具有第一夹角,且所述第一夹角在30°~60°之间。Preferably, the brim structure has a tip portion to extend into the limiting member, the tip portion has a first included angle, and the first included angle is between 30 ° and 60 °.

优选的,所述第一夹角为45°。Preferably, the first included angle is 45 °.

优选的,所述第一夹角由所述帽檐结构的一侧边以及一底边限定而成,所述底边沿所述本体的径向延伸,且所述底边与所述本体之轴向形成第二夹角,所述第二夹角在80°~110°之间。Preferably, the first included angle is defined by a side edge of the brim structure and a bottom edge, the bottom edge extends in a radial direction of the body, and the bottom edge and an axial direction of the body A second included angle is formed, and the second included angle is between 80 ° and 110 °.

优选的,所述第二夹角为90°。Preferably, the second included angle is 90 °.

优选的,最靠近所述本体之近端的一个所述帽檐结构的最大直径大于其余 帽檐结构的最大直径。Preferably, the maximum diameter of one of the brim structures closest to the proximal end of the body is larger than the maximum diameter of the other brim structures.

优选的,最靠近所述本体之近端的一个所述帽檐结构的最大直径为其余帽檐结构的最大直径的1.05倍。Preferably, the maximum diameter of one of the brim structures closest to the proximal end of the body is 1.05 times the maximum diameter of the other brim structures.

优选的,多个所述帽檐结构沿轴向首尾连接设置。Preferably, a plurality of the brim structures are connected end to end along the axial direction.

优选的,多个所述帽檐结构沿轴向间隔设置。Preferably, a plurality of the brim structures are arranged at intervals in the axial direction.

优选的,所述镂空结构包括多个,其中部分镂空结构位于相邻帽檐结构之间至少部分的间隔。Preferably, the hollowed-out structure includes a plurality of hollowed-out structures, wherein a part of the hollowed-out structures is located at least partially between adjacent hat brim structures.

优选的,所述本体从远端至近端依次包括连接部分、支撑部分和加热部分;所述连接部分用于连接一外部构件,所述内腔自所述加热部分的近端轴向延伸至所述支撑部分的远端,其中:多个所述帽檐结构设置于所述加热部分的外侧,且所述楼空结构位于所述加热部分上邻近所述支撑部分的区域。Preferably, the body includes a connection portion, a support portion, and a heating portion in order from the distal end to the proximal end; the connection portion is used to connect an external member, and the inner cavity extends axially from the proximal end of the heating portion to The distal end of the support portion, wherein a plurality of the brim structures are disposed outside the heating portion, and the floor structure is located on an area of the heating portion adjacent to the support portion.

优选的,所述支撑结构还包括棱柱件,所述棱柱件的横截面为多边形,所述棱柱件位于所述连接部分和/或所述支撑部分。Preferably, the supporting structure further includes a prism member, a cross section of the prism member is polygonal, and the prism member is located at the connecting portion and / or the supporting portion.

优选的,所述内腔包括一预留空间段,所述预留空间段的内径大于所述内腔之其余部分的内径,所述阻挡件位于所述预留空间段中,且所述阻挡件的外径与所述预留空间段的内径相匹配。Preferably, the inner cavity includes a reserved space segment, the inner diameter of the reserved space segment is greater than the inner diameter of the rest of the inner cavity, the blocking member is located in the reserved space segment, and the blocking The outer diameter of the piece matches the inner diameter of the reserved space segment.

优选的,所述帽檐结构为2~8个。Preferably, the number of cap structures is 2-8.

优选的,所述限位件为两端开放的中空结构。Preferably, the limiting member is a hollow structure with two ends open.

综上,在本发明提供的支撑结构、假体以及假体系统中,通过在支撑结构的延长件之近端设置多个帽檐结构,以及在延长件的内腔中增设阻挡件,使得所述假体的限位件被所述帽檐结构切削过的材料的一部分不会溢入延长件用于放置弹性件的内腔中,转而能够溢入帽檐结构之间,从而增加帽檐结构的强度,提升假体的结构支撑力,同时确保假体的延长功能稳定有效。In summary, in the support structure, prosthesis, and prosthesis system provided by the present invention, by providing a plurality of cap structures at the proximal end of the extension of the support structure, and adding a blocking member in the inner cavity of the extension, the said A part of the material of the prosthesis restraint piece cut by the brim structure will not overflow into the inner cavity of the extension member for placing the elastic member, and can instead overflow between the brim structures, thereby increasing the strength of the brim structure, Improve the structural support of the prosthesis, while ensuring that the extension function of the prosthesis is stable and effective.

在优选的实施例中,所述帽檐结构具有伸入限位件的尖端部,且所述尖端部的第一夹角在30°~60°之间,更优选为45°,在这些角度范围内的帽檐结构,其能够提供较优异的结构支撑,且还能够确保延长件运动的顺畅。In a preferred embodiment, the brim structure has a tip portion protruding into the stopper, and a first included angle of the tip portion is between 30 ° and 60 °, and more preferably 45 °, within these angle ranges. The inner brim structure can provide better structural support, and can also ensure smooth movement of the extension.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1是本发明一实施例的假体的分解示意图;FIG. 1 is an exploded schematic view of a prosthesis according to an embodiment of the present invention;

图2是本发明一实施例的延长件的结构示意图;2 is a schematic structural diagram of an extension piece according to an embodiment of the present invention;

图3是本发明一实施例的延长件与弹性件的装配示意图;3 is an assembly diagram of an extension member and an elastic member according to an embodiment of the present invention;

图4是本发明一实施例的延长件的轴向剖面示意图;4 is a schematic axial sectional view of an extension member according to an embodiment of the present invention;

图5是本发明一实施例的延长件之近端的立体图;5 is a perspective view of a proximal end of an extension piece according to an embodiment of the present invention;

图6是本发明一实施例的延长件与限位件相配合并在外部力作用下的受力示意图;FIG. 6 is a schematic diagram of a stress of an extension member cooperating with a limit member and an external force under an embodiment of the present invention; FIG.

图7是本发明另一实施例的延长件与限位件相配合并在外部力作用下的受力示意图;FIG. 7 is a schematic view of a force of an extension member cooperating with a limiting member and under an external force according to another embodiment of the present invention; FIG.

图8是本发明一实施例的限位件制备原料拉伸曲线。FIG. 8 is a drawing of a raw material stretching curve of a stopper according to an embodiment of the present invention.

图中:In the picture:

限位件-1;支撑结构-2;延长件-21;阻挡件-22;弹性件-3;连接部分-211;支撑部分-212;加热部分-213;连接孔-2111;内腔-2112;镂空结构-2113;帽檐结构-2114;预留空间段-2115;销孔-2116;受切削管部-1001;材料堆积管部-1002。Limiting piece-1; supporting structure-2; extension piece-21; blocking piece-22; elastic piece-3; connecting portion-211; supporting portion-212; heating portion-213; connecting hole-2111; inner cavity-2112 Hollow structure-2113; Hat eaves structure-2114; Reserved space section-2115; Pin hole-2116; Cutting tube section -1001; Material stacking tube section -1002.

具体实施方式Detailed ways

为使本发明的目的、优点和特征更加清楚,以下结合附图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。In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and all use inaccurate proportions, which are only used to facilitate and clearly assist the description of the embodiments of the present invention.

如在本发明中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本发明中所使用的,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。在本发明中所述的“远端”、“远侧”是指假体可延伸的一侧;相应的,“近端”、“近侧”是与“远端”、“远侧”相对的一侧。As used in the present invention, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in the present invention, the term "or" is generally used in a meaning including "and / or" unless the content clearly dictates otherwise. In the present invention, "distal" and "distal" refer to the extensible side of the prosthesis; correspondingly, "proximal" and "proximal" are opposite to "distal" and "distal" The side.

本发明的核心思想在于提供一种支撑结构、假体及假体系统,以解决现有的假体延长支撑力不足、弹簧延长功能失效等问题。The core idea of the present invention is to provide a support structure, a prosthesis and a prosthesis system, so as to solve the problems of insufficient support force of the existing prosthesis extension, failure of the spring extension function and the like.

为实现上述思想,本发明提供了一种支撑结构,所述支撑结构包括延长件和阻挡件;所述延长件包括本体和位于所述本体之近端的多个帽檐结构;多个所述帽檐结构沿所述本体径向向外延伸,以伸入一限位件,且多个所述帽檐结构还沿所述本体的轴向排布;所述本体具有远端封闭的内腔,且所述本体在邻 近多个所述帽檐结构的部位设有镂空结构;所述阻挡件为两端开放的中空结构并设置于所述内腔中,用以覆盖所述镂空结构;其中:当多个所述帽檐结构发热时,使所述限位件与多个所述帽檐结构相接触的部位融化,以解除所述限位件对所述支撑结构的限位。To achieve the above idea, the present invention provides a support structure, the support structure includes an extension member and a blocking member; the extension member includes a body and a plurality of brim structures at a proximal end of the body; a plurality of the brim The structure extends outward in the radial direction of the body to extend into a limiting piece, and a plurality of the brim structures are also arranged along the axial direction of the body; the body has an inner cavity closed at the distal end, and The body is provided with a hollow structure at a position adjacent to a plurality of the hat eaves structures; the blocking member is a hollow structure with open ends and is disposed in the inner cavity to cover the hollow structure; wherein: when a plurality of When the brim structure heats up, the positions where the stopper is in contact with a plurality of the brim structure are melted to release the stopper from restricting the support structure.

进而,本发明还提供了包括所述支撑结构的假体,且所述假体还包括外壳、限位件和弹性件,其中:所述外壳具有位于远端的第一开口端部和位于近端的第一封闭端部;所述限位件容置于所述外壳中,并被配置为与所述外壳至少保持轴向相对静止;所述支撑结构的所述延长件容置于所述限位件中,并向所述外壳的远端延伸,并被配置为与所述外壳至少保持周向相对静止,且所述延长件的多个所述帽檐结构伸入所述限位件;所述弹性件部分容置于所述延长件的所述内腔中,即所述弹性件的一端延伸至所述内腔的远端端部,另一端穿过所述阻挡件从所述内腔的近端端部延伸出并延伸至所述外壳或者限位件的近端端部;当所述外壳的外侧施加一交变磁场时,多个所述帽檐结构发热,使所述限位件与多个所述帽檐结构相接触的部位融化,以使所述弹性件以弹性力推动所述延长件沿所述限位件的轴向,向所述外壳的远端移动。Furthermore, the present invention also provides a prosthesis including the supporting structure, and the prosthesis further includes a shell, a limiting member, and an elastic member, wherein the shell has a first open end portion at a distal end and a proximal portion The first closed end of the end; the limiting member is accommodated in the housing, and is configured to maintain at least axial relative static with the housing; the extension of the support structure is accommodated in the housing In the stopper, extending to the distal end of the housing, and configured to maintain at least a relative circumferential staticness with the housing, and a plurality of the brim structures of the extension member project into the stopper; The elastic member is partially accommodated in the inner cavity of the extension member, that is, one end of the elastic member extends to a distal end portion of the inner cavity, and the other end passes through the blocking member from the inner portion. The proximal end of the cavity extends out to the proximal end of the housing or the limiter; when an alternating magnetic field is applied to the outside of the housing, a plurality of the brim structures heat up, causing the limit The parts contacting a plurality of the brim structures are melted, so that the elastic parts are Pushing force of the extension member along the axial direction of the stopper member, moves toward the distal end of the housing.

另外,本发明还提供了一种假体系统,所述假体系统包括所述的假体以及交变磁场发生装置,所述交变磁场发生装置用于提供所述交变磁场,即,交变磁场由交变磁场发生装置产生,交变磁场发生装置是本发明的假体延长的触发器。In addition, the present invention also provides a prosthesis system including the prosthesis and an alternating magnetic field generating device, the alternating magnetic field generating device is configured to provide the alternating magnetic field, that is, an alternating The variable magnetic field is generated by an alternating magnetic field generating device, which is a trigger for prosthesis extension of the present invention.

具体来说,通过在外壳外侧,即人体外设置交变磁场,在交变磁场作用下延长件的帽檐结构处形成涡流,涡流产生的热量使所述限位件与多个所述帽檐结构接触的部位发生融化,减弱了限位件对支撑结构的限位作用,所述支撑结构在所述弹性件推动下沿所述假体的轴向,向所述外壳的远端移动,即向假体外部延长。本发明的假体系统,设计结构简单,日常使用过程可以提供较高的支撑力,可靠性高。Specifically, by providing an alternating magnetic field on the outer side of the shell, that is, outside the human body, an eddy current is formed at the brim structure of the extension member under the action of the alternating magnetic field, and the heat generated by the eddy current makes the limiting member contact a plurality of the brim structures The melting of the part reduces the limiting effect of the limiting member on the supporting structure. The supporting structure is moved by the elastic member along the axial direction of the prosthesis to the distal end of the shell, that is, toward the false Extension outside the body. The prosthesis system of the present invention has a simple design structure, can provide higher support force during daily use, and has high reliability.

如图1所示,本发明实施例提供一种假体,所述假体包括外壳、限位件1、支撑结构2和弹性件3,所述支撑结构2包括延长件21和阻挡件22。为了便于叙述,所述外壳并未在图中示出,但本领域技术人员根据现有技术应能知晓如何实现所述外壳的结构。As shown in FIG. 1, an embodiment of the present invention provides a prosthesis. The prosthesis includes a shell, a limiting member 1, a supporting structure 2, and an elastic member 3. The supporting structure 2 includes an extension member 21 and a blocking member 22. For ease of description, the casing is not shown in the drawings, but those skilled in the art should be able to know how to implement the structure of the casing according to the prior art.

所述限位件1容置于所述外壳中,并被配置为与所述外壳至少保持轴向相对静止,所述限位件1用于对支撑结构2进行限位;所述限位件1的材料优选为树脂,更优选为聚缩醛树脂,所述限位件1的至少远端开放(优选两端开放),所述支撑结构2容置于限位件1中,并且其中的延长件21向所述外壳的远端外部延伸,进一步所述延长件21被配置为与所述外壳保持周向相对静止,以此延长件21不能相对于所述外壳随意转动。The limiter 1 is housed in the housing and is configured to maintain at least axial relative static with the housing. The limiter 1 is used to limit the support structure 2; the limiter The material of 1 is preferably a resin, more preferably a polyacetal resin, at least the distal end of the stopper 1 is open (preferably both ends are open), the support structure 2 is accommodated in the stopper 1, and The extension piece 21 extends to the outside of the distal end of the housing. Further, the extension piece 21 is configured to remain relatively stationary with the housing in the circumferential direction, so that the extension piece 21 cannot rotate at will relative to the housing.

如图2所示,本发明实施例提供一种支撑结构2,所述支撑结构2包括所述延长件21和阻挡件22,所述延长件21包括本体以及设于所述本体之近端的多个帽檐结构2114,多个所述帽檐结构2114沿所述本体的轴向排列。其中:任意一个所述帽檐结构2114沿所述本体径向向外延伸并伸入所述限位件1。这里的“径向延伸”不能狭义认为所述帽檐结构2114只能沿垂直于本体轴向的方向延伸,而应广义的理解为所述帽檐结构不是沿所述本体的轴向方向延伸。所述延长件21是相对于外壳为轴向可移动的部分,其利用多个帽檐结构2114的发热解除限位件1对其的限位,以实现假体的延长。As shown in FIG. 2, an embodiment of the present invention provides a support structure 2. The support structure 2 includes the extension member 21 and a blocking member 22. The extension member 21 includes a main body and a proximal end provided on the main body. A plurality of brim structures 2114 are arranged along an axial direction of the body. Wherein, any one of the brim structures 2114 extends outward in the radial direction of the body and projects into the limiting member 1. The “radial extension” here cannot be narrowly considered that the brim structure 2114 can only extend in a direction perpendicular to the axial direction of the body, but it should be broadly understood that the brim structure does not extend in the axial direction of the body. The extension piece 21 is an axially movable part relative to the shell. The extension piece 21 is used to release the restriction member 1 from the restriction by the heat generated by the plurality of brim structures 2114 to achieve the extension of the prosthesis.

此外,所述延长件21的本体具有远端封闭的内腔2112(为内部结构,在图2和图3中以虚线绘示),且所述延长件21的本体在临近多个所述帽檐结构2114的部位还设有镂空结构2113,以阻止本体部分在交变磁场作用下加热。另外,所述阻挡件22位于所述内腔2112中,用以覆盖所述本体上所有镂空结构2113,可以阻止限位件1受热产生的热熔材料通过镂空结构2113流入内腔2112内,同时促使所述热熔材料滞留于帽檐结构2114之间,冷凝后为可延长假体的日常使用提供足够的支撑力。其次,所述阻挡件22还为两端开放的中空结构以允许弹性件3穿设。In addition, the body of the extension piece 21 has a closed inner cavity 2112 (which is an internal structure, and is shown by dashed lines in FIGS. 2 and 3), and the body of the extension piece 21 is adjacent to a plurality of the brim A hollow structure 2113 is also provided at the part of the structure 2114 to prevent the body part from heating under the action of an alternating magnetic field. In addition, the blocking member 22 is located in the inner cavity 2112 to cover all the hollow structures 2113 on the body, and can prevent the hot-melt material generated by the heating of the stopper 1 from flowing into the inner cavity 2112 through the hollow structure 2113. Promote the hot-melt material to stay between the brim structures 2114, and provide sufficient support for the daily use of the prosthesis after condensation. Secondly, the blocking member 22 is also a hollow structure with open ends to allow the elastic member 3 to pass through.

具体而言,如图3所示,所述延长件21的所述内腔2112的近端开放但远端封闭,即该内腔2112为自所述本体的近端向远端延伸的盲孔结构。实际上,所述弹性件3部分容置于所述内腔2112中,即所述弹性件3的一端延伸至所述内腔2112的远端端部,另一端穿过阻挡件22从内腔2112的近端端部延伸出并进一步延伸至所述外壳的近端端部,其中,该弹性件3在延长件21内的部分在图中以虚线绘示。此时,所述限位件1可以是两端开放的中空结构,以允许弹性件3穿过其近端并与外壳连接。亦或,所述限位件1可以是近端封闭的中空 结构,所述弹性件3的近端与所述限位件1的封闭端连接。所述弹性件3用以向所述延长件21提供弹性力,该弹性力的方向指向延长件21的远端。所述弹性件3一般选用弹簧,如钴铬合金材料制成的弹簧,所述弹簧的长度不作具体的限定,以能够提供足够的弹性力为宜。Specifically, as shown in FIG. 3, the proximal end of the inner cavity 2112 of the extension member 21 is open but the distal end is closed, that is, the inner cavity 2112 is a blind hole extending from the proximal end to the distal end of the body. structure. In fact, the elastic member 3 is partially accommodated in the inner cavity 2112, that is, one end of the elastic member 3 extends to the distal end of the inner cavity 2112, and the other end passes through the blocking member 22 from the inner cavity. The proximal end portion of 2112 extends out and further extends to the proximal end portion of the housing, wherein the portion of the elastic member 3 in the extension member 21 is shown by dashed lines in the figure. At this time, the limiting member 1 may be a hollow structure with two ends open to allow the elastic member 3 to pass through its proximal end and connect with the shell. Alternatively, the limiting member 1 may be a hollow structure with a closed proximal end, and the proximal end of the elastic member 3 is connected to the closed end of the limiting member 1. The elastic member 3 is configured to provide an elastic force to the extension member 21, and a direction of the elastic force is directed to a distal end of the extension member 21. The elastic member 3 generally uses a spring, such as a spring made of a cobalt-chromium alloy material, and the length of the spring is not specifically limited, so as to provide sufficient elastic force.

发明人发现,由于人体运动复杂,导致所述支撑结构2受力也比较复杂。简单而言,如图6所示,当所述假体的外部对支撑结构2施加的作用力F1大于弹性件3对支撑结构2提供的弹性力F2时,所述限位件1对支撑结构2所提供的作用力F3的方向与F1的方向相反,即,F1=F2+F3,显然,此时的限位件1明显对支撑结构2提供支撑力。然而,如图7所示,当所述假体的外部对支撑结构2施加的作用力F1小于弹性件3对支撑结构2提供的弹性力F2时,所述限位件1对支撑结构2所提供的作用力F3'的方向与F1的方向相同,即,F2=F1+F3',此时,所述限位件1便对支撑结构2提供阻挡力。因此,根据假体的外部对支撑结构2所施加的作用力F1的大小的不同,所述限位件1能够对支撑结构2提供与弹性力F2方向相同的支撑力,或提供与弹性力F2方向相反的阻挡力。其中,应理解,所述限位件1对支撑结构2所提供的作用力,即是指限位件1对延长件21上帽檐结构2114所施加的作用力。The inventor has found that due to the complex movements of the human body, the forces on the support structure 2 are also relatively complicated. In brief, as shown in FIG. 6, when the force F1 applied to the support structure 2 by the outside of the prosthesis is greater than the elastic force F2 provided by the elastic member 3 to the support structure 2, the limit member 1 pairs the support structure. The direction of the acting force F3 provided by 2 is opposite to the direction of F1, that is, F1 = F2 + F3. Obviously, the stopper 1 at this time obviously provides a supporting force to the supporting structure 2. However, as shown in FIG. 7, when the force F1 exerted on the support structure 2 by the outside of the prosthesis is smaller than the elastic force F2 provided by the elastic member 3 on the support structure 2, the limit member 1 affects the support structure 2. The direction of the applied force F3 ′ is the same as the direction of F1, that is, F2 = F1 + F3 ′. At this time, the stopper 1 provides a blocking force to the support structure 2. Therefore, according to the magnitude of the acting force F1 exerted on the support structure 2 by the outside of the prosthesis, the limiter 1 can provide the supporting structure 2 with a supporting force in the same direction as the elastic force F2 or the elastic force F2. The blocking force in the opposite direction. It should be understood that the force provided by the limiter 1 on the support structure 2 refers to the force exerted by the limiter 1 on the brim structure 2114 on the extension member 21.

因此,当对假体进行延长操作时,病人平躺在手术病床上,由于肢体平放,F1可近似为零,此时对帽檐结构2114处施加交变磁场,限位件1对应于帽檐结构2114处由于受热而变软,使得限位件1对所述延长件21施加的作用力F3'变小,从而便于弹性力克服限位件1的阻挡,最终使延长件21在弹性件3的弹性力F2作用下相对于所述限位件1运动。而且,在相对运动中,所述帽檐结构2114会切削受热而变软部分的限位件1,从而在限位件1上形成被切削过的受削管部1001。Therefore, when the prosthesis is extended, the patient lies flat on the surgical bed, and F1 can be approximately zero due to the limbs lying flat. At this time, an alternating magnetic field is applied to the brim structure 2114, and the stopper 1 corresponds to the brim structure At 2114, it becomes soft due to heat, so that the force F3 'exerted by the limiter 1 on the extension member 21 becomes smaller, thereby facilitating the elastic force to overcome the blockage of the limiter 1, and finally the extension member 21 in the elastic member 3 The elastic force F2 moves relative to the limiting member 1. In addition, during relative movement, the cap structure 2114 cuts the stopper 1 that is softened due to heat, thereby forming the cut pipe portion 1001 on the stopper 1.

在传统的假体中,限位件受热熔化产生的热熔材料,一部分会溢入延长件与限位件之间的空间,一部分会通过镂空结构流入延长件的内腔,凝结在弹性件上,影响弹性件的伸缩。此外,发明人还发现,在传统的假体中,当实施假体延长术后,所述限位件1对延长件21上帽檐结构2114所施加的支撑力,主要由受削管部1001来实现。但是,在传统的假体中,延长件上通常只设有一个帽檐结构,使得限位件的受削管部对帽檐结构提供的支撑力明显不足。In a traditional prosthesis, a part of the hot-melt material generated by the thermal melting of the limiter will overflow into the space between the extension and the limiter, and a part will flow into the inner cavity of the extension through the hollow structure and condense on the elastic member. , Affecting the expansion and contraction of the elastic member. In addition, the inventor also found that in the traditional prosthesis, when the prosthesis is extended, the supporting force exerted by the stopper 1 on the brim structure 2114 on the extension 21 is mainly provided by the cut tube portion 1001. achieve. However, in the traditional prosthesis, there is usually only one brim structure on the extension member, so that the support provided by the cut pipe portion of the stopper to the brim structure is insufficient.

为此,本发明通过在限位件1的本体上沿轴向设置多个帽檐结构2114和在内腔2112中设置覆盖镂空结构2113的阻挡件22,克服了上述缺陷。具体来说,在假体延长过程中,由于阻挡件22的作用,避免了热熔材料通过镂空结构2113渗入内腔2112中,所述热熔材料转而会溢入帽檐结构2114之间形成材料堆积管部1002。这部分材料堆积管部1002在冷凝后会对所述帽檐结构2114提供支撑力,并结合所述受削管部1001提供的支撑力,两者共同提升支撑结构2的支撑力,解决单个帽檐结构支撑力不足这一问题。与此同时,由于所述阻挡件22的设置,还能够阻止热熔材料通过镂空结构2113流入延长件21的内腔2112凝结在弹性件上,确保弹性件3的正常伸缩,保障假体的延长功能。For this reason, the present invention overcomes the above-mentioned defects by providing a plurality of cap structures 2114 along the axial direction on the body of the limiting member 1 and a blocking member 22 covering the hollow structure 2113 in the inner cavity 2112. Specifically, during the extension of the prosthesis, due to the role of the blocking member 22, the penetration of the hot-melt material into the inner cavity 2112 through the hollow structure 2113 is avoided, and the hot-melt material will in turn overflow into the material formed between the brim structures 2114 Stacked tube section 1002. This part of the material stacking pipe portion 1002 will provide the supporting force to the brim structure 2114 after condensing, and combined with the supporting force provided by the cut pipe portion 1001, the two will jointly increase the supporting force of the supporting structure 2 to solve a single brim structure The problem of insufficient support. At the same time, due to the installation of the blocking member 22, the hot melt material can also be prevented from flowing into the inner cavity 2112 of the extension member 21 through the hollow structure 2113 to condense on the elastic member, ensuring the normal expansion and contraction of the elastic member 3, and ensuring the extension of the prosthesis. Features.

所述阻挡件22的材料优选为耐热材料,以避免阻挡件22受热融化或变软,影响其使用。The material of the blocking member 22 is preferably a heat-resistant material, so as to prevent the blocking member 22 from being melted or softened by heat and affecting its use.

如图4所示,所述内腔2112的近端设有预留空间段2115,且所述预留空间段2115的内径大于内腔2112之其余部分的内径。所述预留空间段2115的内径与阻挡件22的外径相匹配(如过盈配合),以容纳所述阻挡件22。所述阻挡件22的内径可允许弹性件3穿过并相对于其自由伸缩。这里,所述预留空间段2115和阻挡件22的轴向长度足够长,以使阻挡件22能覆盖所有的镂空结构2113。本发明实施例中,所述预留空间段2115的轴向长度可等于下述加热部分213的轴向长度,但不以此为限,具体根据镂空结构2113所布置的轴向范围来确定。As shown in FIG. 4, a reserved space section 2115 is provided at the proximal end of the inner cavity 2112, and the inner diameter of the reserved space section 2115 is larger than the inner diameter of the rest of the inner cavity 2112. The inner diameter of the reserved space segment 2115 matches the outer diameter of the blocking member 22 (such as an interference fit) to accommodate the blocking member 22. The inner diameter of the blocking member 22 allows the elastic member 3 to pass through and freely expand and contract with respect to it. Here, the axial length of the reserved space segment 2115 and the blocking member 22 is sufficiently long so that the blocking member 22 can cover all the hollow structures 2113. In the embodiment of the present invention, the axial length of the reserved space segment 2115 may be equal to the axial length of the heating portion 213 described below, but is not limited thereto, and is specifically determined according to the axial range in which the hollow structure 2113 is arranged.

进一步,如图2所示,所述延长件21的所述本体从远端至近端依次包括连接部分211、支撑部分212和加热部分213,亦即,AB段对应的是连接部分211,BC段对应的是支撑部分212,CD段对应的是加热部分213。但各部分的轴向长度占延长件21的总长度的比值不作具体限制。其中:所述连接部分211用于连接外部构件(如股骨嵌入段),例如图2和图3所示,所述连接部分211通过盲孔型的连接孔2111连接所述外部构件,这里的连接孔2111亦为内部结构并在图中以虚线绘示;优选的,所述连接部分211上还设有与连接孔2111垂直贯通的销孔2116(不可见部分以虚线绘示),用于穿设销轴以固定延长件21,防止延长件21相对于外部构件运动;所述内腔2112贯穿所述支撑部分212和加热部分213,即所述内腔2112自加热部分213的近端轴向延伸至支撑部分212的远端,所述支撑部分212的远端亦即为连接部分211的近端;所述帽檐结构2114 位于所述加热部分213的外周,且所述镂空结构2113位于加热部分213上邻近支撑部分212的区域。Further, as shown in FIG. 2, the body of the extension member 21 includes a connecting portion 211, a supporting portion 212, and a heating portion 213 in order from the distal end to the proximal end, that is, the AB segment corresponds to the connecting portion 211, BC The segment corresponds to the support portion 212, and the CD segment corresponds to the heating portion 213. However, the ratio of the axial length of each part to the total length of the extension piece 21 is not specifically limited. Wherein, the connection portion 211 is used to connect external components (such as femoral embedding segments), for example, as shown in FIG. 2 and FIG. 3, the connection portion 211 is connected to the external component through a blind hole-type connection hole 2111, and the connection here The hole 2111 is also an internal structure and is shown by a dotted line in the figure. Preferably, the connecting portion 211 is also provided with a pin hole 2116 (the invisible portion is shown by a dotted line) penetrating perpendicularly to the connecting hole 2111. A pin is provided to fix the extension piece 21 to prevent the extension piece 21 from moving relative to an external member; the inner cavity 2112 runs through the support portion 212 and the heating portion 213, that is, the proximal end of the inner cavity 2112 from the heating portion 213 axially Extending to the distal end of the support portion 212, which is the proximal end of the connection portion 211; the brim structure 2114 is located on the outer periphery of the heating portion 213, and the hollow structure 2113 is located on the heating portion An area on 213 adjacent to the support portion 212.

进一步,为了防止延长件21相对于外壳随意转动,所述支撑结构2还包括棱柱件,具体为所述延长件21的本体还包括所述棱柱件,所述棱柱件的横截面为多边形,优选正多边形。所述棱柱件位于所述支撑部分212和连接部分211的至少一个上,亦即,所述本体的至少一部分的横截面(径向截面)形状被构造成棱柱形。显然,这里的棱柱形的角数可以为大于2的任一自然数,例如是三角形、四角形、五角形、六角形等。相应地,所述外壳也有部分横截面形状与所述棱柱件形状相匹配,如此以防止延长件21相对于外壳随意转动。Further, in order to prevent the extension piece 21 from rotating randomly with respect to the housing, the support structure 2 further includes a prism member, specifically, the body of the extension member 21 further includes the prism member, and the cross section of the prism member is polygonal, preferably Regular polygon. The prism member is located on at least one of the support portion 212 and the connection portion 211, that is, a cross-sectional (radial cross-section) shape of at least a portion of the body is configured into a prism shape. Obviously, the angular number of the prism shape here can be any natural number greater than 2, such as a triangle, a quadrangle, a pentagon, a hexagon, and the like. Correspondingly, the outer shell also has a partial cross-sectional shape that matches the shape of the prism member, so as to prevent the extension member 21 from rotating randomly relative to the outer shell.

进一步,多个所述帽檐结构2114可以紧密连接,即首尾连续设置,还可以首尾间隔设置,或者进一步,如图4和图5所示,还可以在相邻帽檐结构2114之间设置镂空结构2113,可以是所有的帽檐结构2114之间的间隔均设置有镂空结构2113,也可以是一部分帽檐结构之间的间隔设置有镂空结构2113。镂空结构的设置,能够有效隔离本体,而使帽檐结构发热,而本体不发热,从而使得限位件1受热更加集中。所述帽檐结构2114在本实施例中,优选为2~8个,更优选为2个。Further, a plurality of the brim structures 2114 may be closely connected, that is, the head and tail are continuously arranged, and the heads and tails may be spaced apart, or further, as shown in FIGS. 4 and 5, a hollow structure 2113 may be provided between adjacent brim structures 2114. The hollow structures 2113 may be provided in the intervals between all the brim structures 2114, or the hollow structures 2113 may be provided in the intervals between a part of the brim structures. The arrangement of the hollow structure can effectively isolate the body, so that the brim structure generates heat, but the body does not generate heat, so that the heating of the limiter 1 is more concentrated. In this embodiment, the number of cap structures 2114 is preferably two to eight, and more preferably two.

为了使限位件1与帽檐结构2114的接触部位融化后,所述帽檐结构2114能够顺利移动到达目标位置,同时所述限位件1与帽檐结构2114之间能够有充分的接触以实现限位件1对帽檐结构2114的支撑作用,分担弹性件3的压力,所述帽檐结构2114的纵剖面(轴向剖面)形状被设计为多边形,更优选为四边形。从图4所示的角度来观察,所述帽檐结构2114的纵剖面形状(单侧)为梯形,优选直角梯形,但不限于梯形,只要为多边形即可。In order to melt the contact portion between the stopper 1 and the brim structure 2114, the brim structure 2114 can smoothly move to the target position, and at the same time, there can be sufficient contact between the stopper 1 and the brim structure 2114 to achieve the limit The supporting effect of the piece 1 on the brim structure 2114 and the pressure of the elastic member 3 are shared. The shape of the longitudinal section (axial section) of the brim structure 2114 is designed as a polygon, and more preferably a quadrangle. Viewed from the angle shown in FIG. 4, the longitudinal cross-sectional shape (one side) of the brim structure 2114 is trapezoidal, preferably a right-angled trapezoid, but is not limited to a trapezoid, as long as it is a polygon.

如图4和图5所示,所述帽檐结构2114具有一尖端部以伸入限位件1。所述尖端部具有第一夹角α,第一夹角α优选在30°~60°之间,更优选为45°,此时能够提供较优异的支撑力,还能够确保延长件运动的顺畅。所述第一夹角α可由所述帽檐结构2114的侧边以及底边限定而成,所述侧边位于底边的远端,也就是说,所述侧边是从远端朝向近端径向向外延伸的。所述底边大致沿所述本体的径向延伸,同理,此处的“径向延伸”亦需要从广义的角度去理解,即所述底边不一定要严格垂直于轴向方向延伸,只要不是沿轴向方向延伸即可。 此外,所述底边与所述本体之轴向还形成第二夹角β,所述第二夹角用于限定所述帽檐结构的径向延伸方向,且所述第二夹角β优选在80°~110°之间,更优选为90°。如此配置,所述帽檐结构在受力均匀、防止损伤以及易加工等方面具有一定的优势。As shown in FIGS. 4 and 5, the brim structure 2114 has a tip portion to extend into the limiting member 1. The tip portion has a first included angle α, and the first included angle α is preferably between 30 ° and 60 °, and more preferably 45 °. At this time, it can provide better support and ensure smooth movement of the extension member. . The first included angle α may be defined by a side edge and a bottom edge of the brim structure 2114, and the side edge is located at a distal end of the bottom edge, that is, the side edge is from the distal end toward the proximal end. Extending outward. The bottom edge extends substantially along the radial direction of the body. Similarly, the "radial extension" here also needs to be understood from a broad perspective, that is, the bottom edge does not necessarily extend strictly perpendicular to the axial direction. As long as it does not extend in the axial direction. In addition, a second included angle β is formed between the bottom edge and the axial direction of the body, the second included angle is used to define a radial extension direction of the brim structure, and the second included angle β is preferably at It is between 80 ° and 110 °, and more preferably 90 °. With this configuration, the brim structure has certain advantages in terms of uniform force, damage prevention, and easy processing.

进一步,在多个帽檐结构中,最靠近所述本体之近端的一个帽檐结构2114的最大直径优选大于其余帽檐结构的最大直径,例如为其余帽檐结构之最大直径的1.05倍左右,在假体延长时,可通过靠近延长件21近端的一个帽檐结构的大直径来进一步阻挡热熔材料向近端流动,以使得帽檐结构之间可以获得更多的材料堆积管部1002,保障支撑结构2能获得足够的支撑力。Further, among the plurality of brim structures, the largest diameter of the brim structure 2114 closest to the proximal end of the body is preferably larger than the maximum diameter of the other brim structures, for example, about 1.05 times the maximum diameter of the other brim structures, in the prosthesis During the extension, the large diameter of a brim structure near the proximal end of the extension 21 can be used to further block the flow of the hot melt material to the proximal end, so that more material stacking tube portions 1002 can be obtained between the brim structure and the support structure 2 Can get enough support.

如图8所示为本发明一实施例的限位件制备原料的拉伸曲线,其中的制备原料为聚缩醛材料(POM),横坐标为应变(%),纵坐标为应力(MPa),且自上而下所对应的测试温度为-40℃、23℃、40℃、60℃、80℃。从图中可以看出,在室温23℃下,所述聚缩醛材料的极限应力值为60Mpa左右(测试方法依据标准GB/T 22271.2-2008)。此外,作为对比,将现有技术CN107518961A中采用单帽檐结构的可延长假体与本发明双帽檐结构的可延长假体承受载荷与限位件1的承受应力关系列示于下表中(测试方法依据标准GB/T 7314-2017),其中现有技术与本发明的帽檐结构2114的纵剖面形状均为直角梯形,第一夹角α均为45°,第二夹角β均为90°,帽檐结构2114的最大外径均为19mm。As shown in FIG. 8, a tensile curve of a raw material for preparing a stopper according to an embodiment of the present invention, wherein the raw material for the preparation is polyacetal material (POM), the abscissa is strain (%), and the ordinate is stress (MPa). , And the corresponding test temperature from top to bottom is -40 ° C, 23 ° C, 40 ° C, 60 ° C, 80 ° C. It can be seen from the figure that the limiting stress value of the polyacetal material is about 60Mpa at a room temperature of 23 ° C (the test method is based on the standard GB / T 22271.2-2008). In addition, as a comparison, the relationship between the load of the prolongable prosthesis with a single brim structure in the prior art CN107518961A and the extendable prosthesis with a double brim structure of the present invention and the stress resistance of the limiter 1 is shown in the following table (test The method is based on the standard GB / T7314-2017), in which the longitudinal section shapes of the brim structure 2114 of the prior art and the present invention are right-angled trapezoids, the first included angle α is 45 °, and the second included angle β is 90 ° The maximum outer diameter of the brim structure 2114 is 19 mm.

Figure PCTCN2018114424-appb-000001
Figure PCTCN2018114424-appb-000001

从表中可以看出,在限位件的聚缩醛材料的极限应力值附近,本实施例中的可延长假体的可以承受载荷是现有技术的2~3倍。因此,本发明的可延长假体可提供足够的支撑力。It can be seen from the table that, in the vicinity of the limit stress value of the polyacetal material of the stopper, the load that the prolongable prosthesis in this embodiment can withstand is 2-3 times that of the prior art. Therefore, the extendable prosthesis of the present invention can provide sufficient support.

总之,在本发明提供的支撑结构、假体及假体系统设计结构简单,日常使用时可以提供较高的支撑力,假体向外部延长的过程稳定可控,克服了现有技术中的假体安全性差的问题。所述支撑结构2包括所述延长件21和阻挡件22。所述延长件21包括本体和位于本体近端的多个帽檐结构2114,多个所述帽檐结构沿本体径向向外延伸并延伸进入限位件1,可使限位件1与延长件21在平时情况下固定,不会产生轴向相对移动。在需要延长时,对假体施以交变磁场,所述帽檐结构发热以融化与其接触部分的限位件1,进而在弹性力作用下,所述延长件21向远端移动,而所述延长件21设有多个帽檐结构2114以及阻挡件22设置在内腔2112中以覆盖镂空结构2113,使所述限位件1上被切削留下的材料进入帽檐结构2114之间,增加对支撑结构2的支撑力,同时避免了材料通过镂空结构2113溢入内腔2112,影响弹性件3的伸缩。In short, the support structure, prosthesis, and prosthesis system provided by the present invention have a simple design structure, which can provide a high support force in daily use, and the process of extending the prosthesis to the outside is stable and controllable, which overcomes the false in the prior art. The problem of poor body safety. The support structure 2 includes the extension member 21 and the blocking member 22. The extension piece 21 includes a main body and a plurality of hat eaves structures 2114 located at the proximal end of the body. The plurality of hat eaves structures extend outward in the radial direction of the body and extend into the stopper 1 so that the stopper 1 and the extension 21 It is fixed under normal circumstances and will not produce axial relative movement. When prolongation is required, an alternating magnetic field is applied to the prosthesis, and the brim structure generates heat to melt the stopper 1 in contact with the prosthesis. Then, under the action of elastic force, the extension 21 moves to the distal end, and the The extension member 21 is provided with a plurality of brim structures 2114 and a blocking member 22 is provided in the inner cavity 2112 to cover the hollow structure 2113, so that the material left by the cutting on the stopper 1 enters between the brim structures 2114 to increase support. The supporting force of the structure 2 prevents the material from overflowing into the inner cavity 2112 through the hollow structure 2113, and affects the expansion and contraction of the elastic member 3.

综上,上述实施例对支撑结构、假体及假体系统的不同构型进行了详细说明,当然,本发明包括但不同限于上述实施中所列举的构型,任何在上述实施例提供的构型基础上进行变换的内容,均属于本发明所保护的范围。本领域技术人员可以根据上述实施例的内容举一反三。In summary, the above embodiments have described in detail the different configurations of the support structure, the prosthesis, and the prosthesis system. Of course, the present invention includes, but is not limited to, the configurations listed in the above embodiments. Any of the configurations provided in the above embodiments The content that is transformed on the basis of the model belongs to the scope protected by the present invention. Those skilled in the art can learn from the contents of the above embodiments.

上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the art according to the above disclosure shall fall into the protection scope of the claims.

Claims (17)

一种支撑结构,用于假体的支撑,其特征在于,包括延长件和阻挡件;A support structure for supporting a prosthesis, characterized in that it includes an extension member and a blocking member; 所述延长件包括本体和位于所述本体之近端的多个帽檐结构;每个所述帽檐结构沿所述本体径向向外延伸,以伸入一限位件,且多个所述帽檐结构还沿所述本体的轴向排布;The extension member includes a body and a plurality of brim structures located at a proximal end of the body; each of the brim structures extends radially outwardly of the body to extend into a limiting piece, and a plurality of the brim The structure is also arranged along the axial direction of the body; 所述本体具有远端封闭的内腔,且所述本体在邻近多个所述帽檐结构的部位设有镂空结构;所述阻挡件为两端开放的中空结构并设置于所述内腔中,用以覆盖所述镂空结构;The body has an inner cavity closed at the distal end, and the body is provided with a hollow structure at a position adjacent to a plurality of the brim structures; the blocking member is a hollow structure with open ends and is disposed in the inner cavity, For covering the hollow structure; 其中:当多个所述帽檐结构发热时,所述限位件与多个所述帽檐结构相接触的部位融化,以解除所述限位件对所述支撑结构的限位。Wherein, when a plurality of the brim structures are heated, the contact portions of the stopper with the plurality of brim structures are melted, so as to release the stoppers from restricting the support structure. 根据权利要求1所述的支撑结构,其特征在于,所述帽檐结构具有一尖端部以伸入所述限位件,所述尖端部具有第一夹角,且所述第一夹角在30°~60°之间。The support structure according to claim 1, wherein the brim structure has a tip portion to extend into the limiting member, the tip portion has a first included angle, and the first included angle is 30 ° ~ 60 °. 根据权利要求2所述的支撑结构,其特征在于,所述第一夹角为45°。The support structure according to claim 2, wherein the first included angle is 45 °. 根据权利要求2所述的支撑结构,其特征在于,所述第一夹角由所述帽檐结构的一侧边以及一底边限定而成,所述底边沿所述本体的径向延伸,且所述底边与所述本体之轴向形成第二夹角,所述第二夹角在80°~110°之间。The support structure according to claim 2, wherein the first included angle is defined by a side edge and a bottom edge of the brim structure, and the bottom edge extends along a radial direction of the body, and A second included angle is formed between the bottom edge and the axial direction of the body, and the second included angle is between 80 ° and 110 °. 根据权利要求4所述的支撑结构,其特征在于,所述第二夹角为90°。The support structure according to claim 4, wherein the second included angle is 90 °. 根据权利要求1或2所述的支撑结构,其特征在于,最靠近所述本体之近端的一个所述帽檐结构的最大直径大于其余帽檐结构的最大直径。The support structure according to claim 1 or 2, wherein a maximum diameter of one of the brim structures closest to the proximal end of the body is larger than a maximum diameter of the other brim structures. 根据权利要求6所述的支撑结构,其特征在于,最靠近所述本体之近端的一个所述帽檐结构的最大直径为其余帽檐结构的最大直径的1.05倍。The support structure according to claim 6, wherein the maximum diameter of one of the brim structures closest to the proximal end of the body is 1.05 times the maximum diameter of the remaining brim structures. 根据权利要求1或2所述的支撑结构,其特征在于,多个所述帽檐结构沿轴向首尾连接设置。The support structure according to claim 1 or 2, wherein a plurality of the brim structures are connected end to end along the axial direction. 根据权利要求1或2所述的支撑结构,其特征在于,多个所述帽檐结构沿轴向间隔设置。The support structure according to claim 1 or 2, wherein a plurality of the brim structures are arranged at intervals in the axial direction. 根据权利要求9所述的支撑结构,其特征在于,所述镂空结构包括多个,其中部分镂空结构位于相邻帽檐结构之间至少部分的间隔。The support structure according to claim 9, wherein the hollowed-out structure comprises a plurality of hollowed-out structures, wherein a part of the hollowed-out structures are located at least partially between adjacent hat brim structures. 根据权利要求1或2所述的支撑结构,其特征在于,所述本体从远端至近端依次包括连接部分、支撑部分和加热部分;所述连接部分用于连接一外部构件,所述内腔自所述加热部分的近端轴向延伸至所述支撑部分的远端,其中:多个所述帽檐结构设置于所述加热部分的外侧,且所述镂空结构位于所述加热部分上邻近所述支撑部分的区域。The support structure according to claim 1 or 2, wherein the body comprises a connecting portion, a supporting portion, and a heating portion in order from the distal end to the proximal end; the connecting portion is used to connect an external member, the inner portion The cavity extends axially from the proximal end of the heating portion to the distal end of the support portion, wherein a plurality of the brim structures are disposed outside the heating portion, and the hollow structure is located adjacent to the heating portion An area of the support portion. 根据权利要求11所述的支撑结构,其特征在于,所述支撑结构还包括棱柱件,所述棱柱件的横截面为多边形,所述棱柱件位于所述连接部分和/或所述支撑部分。The support structure according to claim 11, wherein the support structure further comprises a prism member, a cross section of the prism member is polygonal, and the prism member is located at the connection portion and / or the support portion. 根据权利要求1或2所述的支撑结构,其特征在于,所述内腔包括一预留空间段,所述预留空间段的内径大于所述内腔之其余部分的内径,所述阻挡件位于所述预留空间段中,且所述阻挡件的外径与所述预留空间段的内径相匹配。The support structure according to claim 1 or 2, wherein the inner cavity includes a reserved space segment, an inner diameter of the reserved space segment is greater than an inner diameter of the remaining portion of the inner cavity, and the blocking member It is located in the reserved space section, and an outer diameter of the blocking member matches an inner diameter of the reserved space section. 根据权利要求1或2所述的支撑结构,其特征在于,包括2~8个所述帽檐结构。The support structure according to claim 1 or 2, further comprising 2 to 8 of the brim structures. 一种假体,其特征在于,包括外壳、限位件、弹性件和如权利要求1-14中任一项所述的支撑结构,其中:A prosthesis, comprising a housing, a limiting member, an elastic member, and the supporting structure according to any one of claims 1-14, wherein: 所述外壳具有位于远端的第一开口端部和位于近端的第一封闭端部;The housing has a first open end at a distal end and a first closed end at a proximal end; 所述限位件容置于所述外壳中,并被配置为与所述外壳至少保持轴向相对静止;The limiting member is accommodated in the casing, and is configured to be at least axially relatively stationary with the casing; 所述支撑结构的所述延长件容置于所述限位件中,并向所述外壳的远端延伸,并被配置为与所述外壳至少保持周向相对静止,且所述延长件的多个所述帽檐结构伸入所述限位件;The extension of the support structure is accommodated in the limiting member, and extends to the distal end of the housing, and is configured to remain relatively stationary at least circumferentially with the housing, and the extension of A plurality of the brim structures project into the limiting member; 所述弹性件部分容置于所述延长件的所述内腔中,且所述弹性件的一端延伸至所述内腔的远端端部,另一端穿过所述阻挡件从所述内腔的近端端部延伸出并延伸至所述外壳或者所述限位件的近端端部;The elastic member is partially accommodated in the inner cavity of the extension member, and one end of the elastic member extends to a distal end of the inner cavity, and the other end passes through the blocking member from the inner portion. The proximal end of the cavity extends out and extends to the proximal end of the housing or the stopper; 当所述外壳的外侧施加一交变磁场时,多个所述帽檐结构发热,使所述限位件与多个所述帽檐结构相接触的部位融化,以使所述弹性件以弹性力推动所述延长件沿所述限位件的轴向,向所述外壳的远端移动。When an alternating magnetic field is applied to the outer side of the shell, a plurality of the brim structures heat up, and the portions where the stopper contacts the plurality of brim structures are melted, so that the elastic member is pushed by the elastic force. The extension piece moves to the distal end of the casing along the axial direction of the limiting piece. 根据权利要求15所述的假体,其特征在于,所述限位件为两端开放的 中空结构。The prosthesis according to claim 15, wherein the limiting member is a hollow structure with two ends open. 一种假体系统,其特征在于,包括如权利要求15或16所述的假体和交变磁场发生装置,所述交变磁场发生装置用于提供交变磁场,在所述交变磁场作用下所述帽檐结构发热。A prosthesis system, comprising the prosthesis according to claim 15 or 16 and an alternating magnetic field generating device, wherein the alternating magnetic field generating device is used to provide an alternating magnetic field, and acts on the alternating magnetic field. The brim structure described below generates heat.
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CN108261269B (en) * 2018-05-31 2018-08-28 上海微创医疗器械(集团)有限公司 Support structure, prosthesis and prosthesis system
CN112674912B (en) * 2020-12-30 2022-04-12 北京爱康宜诚医疗器材有限公司 Long bone lengthening prosthesis
CZ310545B6 (en) * 2024-05-31 2025-11-12 Prospon, Spol. S R.O. A distraction device of non-invasively extendable implants

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US9421051B2 (en) * 2013-09-06 2016-08-23 Biomet Manufacturing, Llc Implant fixation assembly
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CZ309950B6 (en) * 2022-09-06 2024-02-28 Prospon, Spol. S R.O. Distraction device for implants

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