WO2022242450A1 - Push rod assembly and medical device - Google Patents

Push rod assembly and medical device Download PDF

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Publication number
WO2022242450A1
WO2022242450A1 PCT/CN2022/090375 CN2022090375W WO2022242450A1 WO 2022242450 A1 WO2022242450 A1 WO 2022242450A1 CN 2022090375 W CN2022090375 W CN 2022090375W WO 2022242450 A1 WO2022242450 A1 WO 2022242450A1
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WO
WIPO (PCT)
Prior art keywords
push rod
sub
rod assembly
limiting
limiting mechanism
Prior art date
Application number
PCT/CN2022/090375
Other languages
French (fr)
Chinese (zh)
Inventor
杨波
张广建
王洪杰
刘梦钦
郭澜涛
苗铮华
Original Assignee
上海鸿脉医疗科技有限公司
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Publication date
Application filed by 上海鸿脉医疗科技有限公司 filed Critical 上海鸿脉医疗科技有限公司
Publication of WO2022242450A1 publication Critical patent/WO2022242450A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

Definitions

  • the invention relates to the technical field of medical devices, in particular to a push rod assembly and a medical device.
  • Cardiovascular disease has become the number one killer threatening human health, including various vascular access abnormalities such as hemangioma, dissection, embolism, and stenosis.
  • embolization coils can be used for embolization therapy.
  • An embolic coil is a permanently implanted wire-wound structure that, when implanted in a diseased area, can form a thrombus in the diseased area to form an embolized blood vessel.
  • the embolic coils can have different lengths or different diameters.
  • the embolic coil is connected to the push rod assembly in the slender form of the primary spring and fixed in the introduction sheath.
  • the loop is pushed into the target area of the blood vessel for release.
  • the embolic coil transforms from a primary spring to a complex 3D shape, such as a spiral, diamond, spherical, etc.
  • Embolic coils are highly flexible and capable of delivery through narrow or tortuous vessel structures, but when closure of larger diameter vessels is required, multiple embolic coils may be required.
  • the purpose of the present invention is to provide a push assembly and a medical device.
  • the push assembly is used to push the medical implant, the medical implant can still be recovered and repositioned after entering the blood vessel, which is beneficial to improve the treatment effect.
  • a push rod assembly comprising:
  • the push rod has a first inner cavity axially penetrated
  • the limiting mechanism includes a first sub-limiting mechanism and a second sub-limiting mechanism; the first sub-limiting mechanism is formed with a first limiting area, and also includes a first stop, the first stop It is arranged at the proximal end of the first limiting area, and the first stop part is provided with a first through hole communicating with the first limiting area; the second sub-limiting mechanism is connected to the the distal end of the push rod; and,
  • the push rod assembly is configured such that when the distal end of the control rod passes through the first inner cavity and the first through hole, and is connected with the distal end portion of the second sub-limiting mechanism, and will When the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in the locked position; when the control rod moves along the axial direction of the first through hole, And when the distal part of the second sub-limiting mechanism is allowed to break away from the first limiting area, the push rod assembly is in the unlocked position.
  • the first limiting area is formed on the side of the first sub-limiting mechanism, and is radially inwardly recessed; the side of the second sub-limiting mechanism is formed with a The second limiting area is recessed inside, and also includes a second stopper, the second stopper is arranged at the distal end of the second limiting area and constitutes the distal part of the second sub-limiting mechanism, A second through hole is provided on the second blocking portion, and the second through hole, the second limiting area and the first inner cavity are sequentially communicated with each other;
  • the control rod When the push rod assembly is in the locked position, the control rod also constrains the first stop part in the second limiting area, and the distal end of the control rod also passes through the first Two through holes; when the control rod moves in the direction from the distal end to the proximal end and the distal end of the control rod is located on the proximal side of the second limiting area, the push rod assembly is in the The unlocked position also allows the first blocking part to disengage from the second limiting area.
  • the second sub-limiting mechanism further includes a first engaging portion, the first engaging portion is located at the proximal end of the second limiting area and is connected to the distal end of the push rod;
  • a third through hole is provided on the first joint portion, and the third through hole communicates with the first inner cavity and the second limiting area, and is used for the distal end of the control rod to pass through.
  • the push rod assembly is used to movably pass through the second lumen of a catheter, so as to deliver a medical implant to a target position.
  • the ratio of the sum of the width of the first blocking portion and the width of the second blocking portion to the diameter of the second inner cavity ranges from 1 to 1.5.
  • the second sub-limiting mechanism includes a deformation part, the deformation part is arranged around the control rod, and the proximal end of the deformation part is connected to the first connection point on the push rod, so The distal end of the deformation part is connected to the second connection point on the control rod; the distal part of the deformation part is the distal part of the second sub-limiting mechanism;
  • the push rod assembly is configured when the distal portion of the deformation part passes through the first through hole and is located in the first limiting area, and the axis between the second connection point and the first connection point When the distance in the radial direction is less than a predetermined value, the distal end portion of the deformation portion is radially expanded to a radial maximum dimension larger than the diameter of the first through hole, so that the distal end portion of the deformation portion is restricted within the first limit.
  • the deformation part In the position zone, when the control rod moves in the direction from the proximal end to the distal end and makes the axial distance from the second connection point to the first connection point equal to the predetermined value, the deformation part The distal end portion of the deformation portion is radially contracted to a radial dimension smaller than or equal to the diameter of the first through hole, so as to allow the distal end portion of the deformation portion to break away from the first limiting area.
  • the deformation part includes a plurality of elastic pieces, and the plurality of elastic pieces are sequentially arranged around the control rod; or, the deformation part is an elastic sleeve, and is sleeved on the outside of the control rod.
  • the first sub-limiting mechanism has a third inner cavity, and the third inner cavity constitutes the first limiting area.
  • the push rod is braided from wire.
  • the diameter of the control rod is 50%-60% of the diameter of the first through hole.
  • the first sub-limiting mechanism further includes a second engaging portion disposed at a distal end of the first limiting area.
  • the present invention also provides a medical device, including a medical implant and the push rod assembly as described in any one of the preceding items, the first sub-limiting mechanism is used to connect to the medical implant the proximal end.
  • the medical implant includes an embolic coil.
  • the pushing assembly and the medical device of the present invention have the following advantages:
  • the foregoing medical device includes a medical implant and a push rod assembly;
  • the push rod assembly includes a push rod, a limit mechanism and a control rod;
  • the push rod has a first inner cavity axially penetrated;
  • the limit mechanism includes The first sub-limiting mechanism and the second sub-limiting mechanism;
  • the first sub-limiting mechanism is connected to the proximal end of the medical implant, and a first limiting area is formed thereon, and also includes a first stop part, the first stop part is arranged at the proximal end of the first limit area, and the first stop part is provided with a first through hole communicating with the first limit area;
  • the second The sub-limiting mechanism is connected to the distal end of the push rod;
  • the push rod assembly is configured such that when the distal end of the control rod passes through the first inner cavity and the first through hole, and is connected with the When the distal part of the second sub-limiting mechanism is connected and the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push
  • the medical implant when the medical implant is pushed by the push rod assembly, as long as the push rod assembly is in the locked position, the medical implant is controlled by the push rod, even if the Once the medical implant has entered the blood vessel, it can still be recovered and repositioned through the push rod, so as to improve the positioning accuracy of the medical implant.
  • the first sub-limiting mechanism and the second sub-limiting mechanism occur when the medical implant is pushed through the curved part of the blood vessel. In the case of early separation, the reliability of the push rod is improved.
  • Fig. 1 is a schematic structural view of the push rod assembly provided according to Embodiment 1 of the present invention, in which the first sub-limiting mechanism is connected to the medical implant;
  • Fig. 2 is a schematic structural view of the first sub-limiting mechanism of the push rod assembly provided according to Embodiment 1 of the present invention
  • Fig. 3 is a schematic diagram of the connection relationship between the first sub-limiting mechanism of the push rod assembly and the medical implant according to Embodiment 1 of the present invention
  • Fig. 4 is a schematic structural view of the second sub-limiting mechanism of the push rod assembly provided according to Embodiment 1 of the present invention.
  • Fig. 5 is a schematic diagram of the connection relationship between the second sub-limiting mechanism, the push rod and the control rod of the push rod assembly provided by the first embodiment of the present invention
  • Fig. 6 is a schematic view of the use scene of the push rod assembly provided according to the first embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located in the second lumen of the catheter;
  • Fig. 7 is a schematic diagram of the use scene of the push rod assembly provided according to the first embodiment of the present invention, which shows that the proximal end of the medical implant is located outside the catheter, and the push rod assembly is still in the locked position;
  • Fig. 8 is a schematic view of the use scene of the push rod assembly provided according to Embodiment 1 of the present invention. It shows that the proximal end of the medical implant is located outside the catheter, the push rod assembly is in the unlocked position, and the first stop can be disengaged from the first limit. Position zone, the second gear can break away from the second limit zone;
  • Fig. 9 is a schematic diagram of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located in the second lumen of the catheter;
  • Fig. 10 is a schematic diagram of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located outside the catheter;
  • Fig. 11 is a schematic view of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the unlocked position, and the distal part of the second sub-limiting mechanism is located in the first limiting area ;
  • Fig. 12 is a schematic view of the use scene of the push rod assembly provided by the second embodiment of the present invention.
  • the push rod assembly is in the unlocked position, and the distal part of the second sub-limiting mechanism is out of the first limiting area.
  • each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • the core idea of the present invention is to provide a push rod assembly, which is used to connect with a medical implant, and push the medical implant to the target position of the target area in the patient's body along a catheter to carry out freed.
  • the push rod assembly includes a push rod, a limit mechanism and a control rod.
  • the push rod has a first inner cavity axially penetrated;
  • the limiting mechanism includes a first sub-limiting mechanism and a second sub-limiting mechanism.
  • the first sub-limiting mechanism is used to connect to the proximal end of the medical implant, the first sub-limiting mechanism is formed with a first limiting area, and also includes a first stop portion, the first sub-limiting mechanism A blocking portion is arranged at the proximal end of the first limiting area, and a first through hole communicating with the first limiting area is formed on the first blocking portion.
  • the second sub-limiting mechanism is connected to the distal end of the push rod.
  • the push rod assembly is configured such that when the distal end of the control rod passes through the first inner chamber and the first through hole and is connected with the distal end portion of the second sub-limiting mechanism, and the When the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in a locked state, and at this time the push rod passes through the limiting mechanism and the medical implant Things stay connected.
  • the control rod moves axially along the first through hole and allows the distal part of the second sub-limiting mechanism to break away from the first limiting area, the push rod assembly is in an unlocked state, In this case the medical implant is decoupled from the push rod or both are allowed to be decoupled.
  • the push rod assembly when the push rod assembly is pushing the medical implant, as long as the push rod assembly is kept at the locked position, even if the medical implant has been completely pushed out of the guide tube (i.e. The proximal end of the medical implant has broken away from the catheter), the push rod can still be used to reclaim the medical implant and adjust the position of the medical implant to improve the medical implant
  • the positioning accuracy of drug release is conducive to improving the therapeutic effect.
  • the medical implant generally refers to an embolism coil.
  • proximal refers to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although “proximal”, “distal ” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the practitioner during normal operation, and “distal” generally refers to the end that enters the patient first.
  • Fig. 1 shows a schematic structural view of the push rod assembly provided by this embodiment.
  • the push rod assembly includes a push rod 100, a limiting mechanism 200 and a control rod 300.
  • the push rod 100 has a first inner cavity axially penetrating.
  • the limiting mechanism 200 includes a first sub-limiting mechanism 210 and a second sub-limiting mechanism 220 .
  • the first sub-limiting mechanism 210 is provided with a first limiting area 211, and also includes a first blocking portion 212, and the first blocking portion 212 is arranged at the proximal end of the first limiting area 211.
  • the first stop portion 212 is provided with a first through hole 213 communicating with the first limiting area 211 .
  • the second sub-limiting mechanism 220 is connected to the distal end of the push rod 100 .
  • the control rod 300 is configured to be movably passed through the first inner cavity and the first through hole 213 .
  • the first sub-limiting mechanism 210 of the push rod assembly is used to be connected to the proximal end of a medical implant such as the embolic coil 10, and is used to push the embolic coil along the second lumen of a catheter 1. 10 is pushed and released to the target location in the target blood vessel in the patient.
  • the push rod assembly has a locked position and an unlocked position.
  • the distal end portion of the second sub-limiting mechanism 220 is located inside the first limiting area 211, and the distal end of the control rod 300 passes through the
  • the first inner chamber and the first through hole 213 are also connected to the distal part of the second sub-limiting mechanism 220, so that the distal part of the second sub-limiting mechanism 220 is limited to the inside the first limiting area 211, and prevent the distal part of the second sub-limiting mechanism 220 from breaking away from the first limiting area, so that the second sub-limiting mechanism 220 and the first sub-limiting mechanism 220
  • the mechanism 210 remains connected so that the operator can control the embolic coil 10 through the push rod 100 and adjust the position of the embolic coil 10 at any time.
  • this push rod assembly is that as long as the push rod assembly is kept at the locking position, in the process of releasing the embolic coil 10, once the operator finds that the position of the embolic coil 10 is not good, Even if the embolic coil 10 has been completely pushed out of the catheter 1, the embolic coil 10 can still be recovered into the catheter 1 and the position of the embolic coil 10 can be readjusted by operating the push rod assembly After releasing, it is beneficial to improve the positioning accuracy of the embolic coil 10 and improve the therapeutic effect.
  • the cross-section of the catheter 1 will be deformed from a circular shape to an ellipse, resulting in an increase in the radial dimension of the cross-section of the catheter 1 in a certain direction.
  • the push rod assembly pushes the embolism coil 10 through the bending position
  • the push rod assembly is in the locked position under the presence of the control rod 300, avoiding the first sub-limit mechanism 210 and
  • the second sub-limiting mechanism 220 is separated in advance due to the change of the radial dimension of the cross-section of the catheter 1 at the bending area (that is, the distal end portion of the second sub-limiting mechanism 220 breaks away from the The above-mentioned first limiting area 211) improves the reliability of the push rod assembly.
  • the push rod 100 can be a tubular structure formed by helically braiding metal wires or cut from a metal tube, which has good flexibility and cornering performance, and can reduce stagnation, Probability of occurrence of discounts etc.
  • the control rod 300 is generally made of a single strand of metal wire, and its diameter may be 50% to 60% of the diameter of the first through hole 213, which not only makes the push rod assembly have better overall flexibility, It also makes the movement space of the control rod 300 smaller in the radial direction, thereby reducing the shaking range of the first sub-limit mechanism 210 and the embolism coil 10 when pushing.
  • a radially inwardly recessed groove is formed on the side of the first sub-limiting mechanism 210 , and the groove can serve as the first limiting area 211 .
  • the first sub-limiting mechanism 210 also includes a second engaging portion 214, the second engaging portion 214 is arranged at the distal end of the first limiting area 211, and constitutes the distal end of the groove side wall.
  • the second engaging portion 214 is used to connect with the proximal end of the embolic coil 10 (as shown in FIG. 3 ).
  • the first blocking portion 212 , the first limiting area 211 and the second joint portion 214 can be formed simultaneously by removing a part of material in the middle area of a cylinder.
  • the distal end of the second engaging portion 214 can be formed such that the cross-section gradually decreases from the proximal end to the distal end.
  • the conical head, and the distal end surface of the conical head matches the cross section of the embolic coil 10 .
  • the second joint portion 214 is provided with a fourth through hole 215 communicating with the first limiting area 211 and the inner cavity of the embolic coil 10 .
  • a second limiting area 221 radially inwardly recessed, and the second limiting area 221 is aligned with the first limiting area of the push rod 100 .
  • the lumen is connected.
  • the second sub-limiting mechanism 220 also includes a second stopper 222, the second stopper 222 is arranged at the distal end of the second limiter area 221, and the second stopper 222 constitutes the second limiter.
  • the second blocking portion 222 is provided with a second through hole 223 , and the second through hole communicates with the second limiting area 221 .
  • the second sub-limiting mechanism 220 also includes a first joint portion 224, which is arranged at the proximal end of the second limiting area 221 and connected with the push rod 100 (as shown in FIG. 5 ).
  • the first joint portion 224 is provided with a third through hole 225 , and the third through hole 225 is used to communicate with the first inner cavity and the second limiting area 221 .
  • the second sub-limiting mechanism 220 can also simultaneously form the second stopper 222 and the second limiting mechanism by removing a part of material in the middle area of a cylinder.
  • the bit area 221 and the first bonding portion 224 are examples of material that are connected to communicate with the first inner cavity and the second limiting area 221 .
  • the first stopper 212 is located in the second limiting area 221
  • the second The blocking part 222 (that is, the distal part of the second sub-limiting mechanism 220) is located in the first limiting area 211, and the distal end of the control rod 300 passes through the first inner cavity, the The third through hole 225, the first through hole 213, the second through hole 223, and preferably through the fourth through hole 215, so that the second blocking portion 222 is limited in the first within the limiting area 211 , and limit the first blocking portion 212 within the second limiting area 221 .
  • the distal end of the control rod 300 can also extend into the lumen of the embolic coil 10 .
  • the first through hole 213 and the fourth through hole 215 extend along the axial direction of the first sub-limiting mechanism 210, and the second through hole 223 and the The third through hole 225 extends along the axial direction of the second sub-limiting mechanism 220 .
  • the push rod assembly uses the push rod assembly to push the embolic coil 10 to the target position in the body along the second lumen of the catheter 1 (at this time, the embolic coil 10 is completely located outside the catheter 1), and The operator can pull the control rod 300 in the direction from the distal end to the proximal end, and when the control rod 300 is retracted until its distal end is on the proximal side of the second limiting area 221, the push rod
  • the second stopper 222 can break away from the first limiting area 211
  • the first stopper 212 can break away from the second limiting area 221
  • the embolism coil 10 is separated from the push rod 100 together with the first sub-limiting mechanism 210 .
  • the ratio of the sum of the width of the first blocking portion 212 and the width of the second blocking portion 222 to the diameter of the second lumen of the catheter 1 is (1 ⁇ 1.5) , for example the ratio is 1.1, 1.2, 1.3 or 1.4 etc. So set, on the one hand, it can ensure that the push rod assembly can push the embolism coil 10 to move along the second inner cavity; Bit mechanism 220 has sufficient strength.
  • the width of the first blocking portion 212 is the depth of the first limiting area 211
  • the width of the second blocking portion 222 is the depth of the second limiting area 221
  • the first The depth of the limiting area 211 and the second limiting area 221 refers to the size of the corresponding limiting area in the radial direction of the push rod assembly.
  • the push rod assembly and the embolism coil 10 are assembled, and the push rod assembly is in the locked position.
  • the embolic coil 10 is introduced into the second lumen of the catheter 1 pre-implanted in the patient's body by using a sheath.
  • the operator applies a pushing force to the push rod assembly at the proximal end of the push rod 100, and pushes the embolic coil 10 to the target position in the body along the second lumen of the catheter 1 , and push the embolic coil 10 to the outside of the catheter 1 (as shown in FIG. 6 and FIG. 7 ), when the embolic coil 10 is completely outside the catheter 1 (as shown in FIG.
  • the operator can apply a retraction force on the proximal end of the control rod 300, so that the control rod 300 moves from the distal end to the proximal end to
  • the proximal side of the second limiting area 221 moves into the first inner cavity of the push rod 100 (as shown in FIG. 8 ), so that the push rod assembly is in the unlocked position, and at this time
  • the second blocking portion 222 can disengage from the first limiting area 211
  • the first blocking portion 212 can disengage from the second limiting area 221 to realize the release of the embolic coil 10 .
  • the operator Before switching the push rod assembly to the unlocked position, if the position of the embolic coil 10 deviates from the target position, the operator can apply a retraction force on the proximal end of the push rod 100 to push the The embolic coil 10 is recovered into the second inner cavity, and released again after the position of the embolic coil 10 is adjusted.
  • this embodiment also provides a medical device, including the medical implant such as the embolic coil 10 and the push rod assembly, the first sub-limiting mechanism 210 of the push rod assembly is connected to The proximal end of the medical implant.
  • the second sub-limiting mechanism 220 includes a deformation part, the deformation part is arranged around the control rod 300, and the proximal end of the deformation part is connected to the At the first connection point on the push rod 100 , the distal end of the deformation part is connected to the second connection point on the control rod 300 .
  • the first connection point is located at the distal end of the push rod 100 and the second connection point is located at the distal end of the control rod 300 . In this way, the distal portion of the deformation portion is the distal portion of the second limiting mechanism 220 .
  • the push rod assembly is configured such that when the distal end of the deformation portion passes through the first through hole 213 together with the distal end of the control rod 300 and is located in the first limiting area 211 , and the When the axial distance from the second connection point to the first connection point is less than a predetermined value, the distal portion of the deformation portion expands radially until the maximum radial dimension of this portion is greater than that of the first through hole 213 Aperture, the distal portion of the deformation part is restricted in the first limiting area 211, so that the push rod assembly is in the locking position.
  • the distal portion of the deformation portion radially shrinks to The maximum radial dimension of this part is less than or equal to the diameter of the first through hole 213, so as to allow the distal part of the deformation part to pass through the first through hole 213 in the direction from the distal end to the proximal end and to be disengaged.
  • the first limiting area 211 at this time, the push rod assembly is in the unlocked position.
  • the radial size of the deformation portion refers to the size of the deformation portion on the radial section of the first sub-limiting mechanism 210 .
  • the meanings of radial expansion and radial contraction are relative, the radial dimension of the distal part of the deformation part changes from small to large, that is, radial expansion, and the radial dimension of this part changes from large to small That is radial shrinkage.
  • the deformation part includes an elastic sleeve, and the elastic sleeve is disposed on the outside of the control rod 300 .
  • the deformation portion includes a plurality of elastic pieces arranged around the control rod 300 , in this case, the predetermined value is equal to the length of the deformation portion in a natural state, and the natural state refers to the When the deformation part is not subjected to external force, the radial dimension of the distal part of the deformation part in the natural state is smaller than or equal to the diameter of the first through hole 213, so that this part of the deformation part can pass through The first through hole 213 .
  • the distal end portion of the deformation portion When the axial distance between the second connection point and the first connection point is smaller than the predetermined value, the distal end portion of the deformation portion is bent and deformed and radially expanded, and when the second connection point and the first connection point are When the axial distance between the first connection points is equal to the predetermined value, the distal end portion of the deformation part returns to a natural state.
  • the deformation part is a self-expanding structure
  • the deformation part may include a plurality of rods that are pre-shaped into an arc, and the plurality of rods are arranged around the control rod 300, and the rods The concave side of is facing the control rod 300, where the predetermined value is greater than the axial length of the control rod 300 when the deformation part is in the natural state, when the deformation part is in the natural state , the radial dimension of the distal portion of the deformation portion is larger than the diameter of the first through hole 213, so that when the push rod assembly is in the locked position, the distal end of the rod body of the deformation portion The part is still in an arc shape, so that the entire distal end of the deformation part is in the shape of a lantern, and when the push rod assembly is in the unlocked position, the rod body can be stretched into a straight shape.
  • the self-expanding structure means that the structural member itself has good resilience, and it deforms when it is subjected to an external force, and when the external force is canceled, the structural member can recover under the action of its own resilience.
  • the self-expanding structure can be made of shape memory alloy.
  • the structure of the first sub-limiting mechanism 210 may be completely the same as that in Embodiment 1, or it may be different.
  • the first sub-limiting mechanism 210 described in the illustration is a hollow structure, which has a third inner cavity, and the third inner cavity constitutes the first limiting area 211 .
  • the second engaging portion 214 of a sub-limiting mechanism 210 may not be provided with a fourth through hole.
  • the push rod assembly and the embolism coil 10 are assembled, and the push rod assembly is in the locked position.
  • the embolic coil 10 is introduced into the second lumen of the catheter 1 that has been pre-implanted in the patient's body through a sheath.
  • a pushing force to the push rod assembly, when the embolic coil 10 is completely outside the catheter 1, if the embolic coil 10 has been correctly positioned, the operator can press the control rod 300 near the end to apply a pushing force, and make the control rod 300 move from the proximal end to the distal end until the axial distance between the second connection point and the first connection point is equal to the predetermined value, so that the The distal portion of the deformation portion is radially contracted until the radial dimension of this portion is smaller than or equal to the diameter of the first through hole 213 , and at this time the push rod assembly is in the unlocked position.
  • the control rod 300 and the push rod 100 axially relatively stationary, and apply a retraction force on the proximal ends of the control rod 300 and the push rod 100, so that the control rod 300 and the push rod 100
  • the rod 100 moves synchronously along the direction from the distal end to the proximal end until the distal end portion of the control rod 300 carries the distal end portion of the deformable portion through the first through hole 213 and is positioned at the first through hole 213.
  • the embolic spring coil 10 carries the first sub-limiting mechanism 210 and disengages from the push rod 100 .
  • the operator Before switching the push rod assembly to the unlocked position, if the positioning of the embolic coil 10 is found to be inaccurate during the process of pushing the embolic coil 10, the operator can withdraw the push rod Assembly to recover the embolic coil 10 to the second lumen of the catheter 1 and release it after adjusting the position.
  • This embodiment also provides a medical device, including a medical implant and the push rod assembly, and the first sub-limiting mechanism 210 of the push rod assembly is connected to the proximal end of the medical implant.
  • the push rod assembly can be switched between the locked position and the unlocked position, and the push rod assembly is used to push and
  • the medical implant can be recovered at any time, so as to adjust the position of the medical implant, which is beneficial to improve
  • the positioning accuracy of the medical implant improves the therapeutic effect.
  • it can also avoid the situation that the first sub-limiting mechanism and the second sub-limiting mechanism disengage early when passing through the bending area of the blood vessel, thereby improving reliability.

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Abstract

A push rod assembly and a medical device. The medical device comprises the push rod assembly and a medical implant. The push rod assembly comprises: a push rod (100), having a first inner cavity; a position-limiting mechanism (200), comprising a first sub position-limiting mechanism (210) and a second sub position-limiting mechanism (220), the first sub position-limiting mechanism (210) being provided at the proximal end of the medical implant, having a first position-limiting area (211) formed thereon, and comprising a first blocking portion (212), the first blocking portion (212) being provided at the proximal end of the first position-limiting area (211), a first through hole (213) being formed in the first blocking portion (212), and the second sub position-limiting mechanism (220) being connected to the distal end of the push rod (100); and a control rod (300), when the distal end of the control rod (300) passes through the first inner cavity and the first through hole (213) and the distal portion of the second sub position-limiting mechanism (220) is limited within the first position-limiting area (211), the push rod assembly being in a locked position, and when the control rod (300) moves along the axial direction of the first through hole (213) to allow the distal portion of the second sub position-limiting mechanism (220) to be separated from the first position-limiting area (211), the push rod assembly being in an unlocked position. When the push rod assembly is used to push a medical implant, the precision of positioning for the medical implant can be improved.

Description

一种推杆组件及医用装置A push rod assembly and medical device 技术领域technical field
本发明涉及医疗器械技术领域,具体涉及一种推杆组件及医用装置。The invention relates to the technical field of medical devices, in particular to a push rod assembly and a medical device.
背景技术Background technique
心血管疾病已成为威胁人类健康的第一杀手,其包括各种血管通路异常例如血管瘤、夹层、栓塞、狭窄等。对于血管疾病例如血管瘤或夹层等,可采用栓塞弹簧圈进行栓塞治疗。栓塞弹簧圈是一种永久植入的绕线结构,其在被植入病变区域时,可在病变区域形成血栓来形成栓塞血管。为了能够栓塞不同直径的血管,栓塞弹簧圈可以具有不同的长度或不同的直径。在使用过程中,栓塞弹簧圈以初级弹簧的细长形态与推杆组件相连并固定在导入鞘中,在导入鞘的作用下,推杆组件将栓塞弹簧圈推进导管,进而沿导管将栓塞弹簧圈推入血管的目标区域进行释放。栓塞弹簧圈被释放之后由初级弹簧转变为复杂的3D形状,例如螺旋型、钻石型、球形等。栓塞弹簧圈高度灵活且能够通过狭窄或曲折的血管结构进行输送,但当需要闭合较大直径的血管时,可能需要使用多个栓塞弹簧圈。Cardiovascular disease has become the number one killer threatening human health, including various vascular access abnormalities such as hemangioma, dissection, embolism, and stenosis. For vascular diseases such as hemangioma or dissection, embolization coils can be used for embolization therapy. An embolic coil is a permanently implanted wire-wound structure that, when implanted in a diseased area, can form a thrombus in the diseased area to form an embolized blood vessel. In order to be able to embolize blood vessels of different diameters, the embolic coils can have different lengths or different diameters. During use, the embolic coil is connected to the push rod assembly in the slender form of the primary spring and fixed in the introduction sheath. The loop is pushed into the target area of the blood vessel for release. After the embolic coil is released, it transforms from a primary spring to a complex 3D shape, such as a spiral, diamond, spherical, etc. Embolic coils are highly flexible and capable of delivery through narrow or tortuous vessel structures, but when closure of larger diameter vessels is required, multiple embolic coils may be required.
在推送及释放栓塞弹簧圈的操作中,存在诸多不确定性的因素可能导致线圈不能很好的在血管中定位,进而引起释放位置不准确,并且现有技术中的推送组件一旦将栓塞弹簧圈推送出导管并进入血管后,难以回撤栓塞弹簧圈,也就难以对栓塞弹簧圈重新定位。In the operation of pushing and releasing the embolic coil, there are many uncertain factors that may cause the coil to not be well positioned in the blood vessel, thereby causing inaccurate release positions, and once the push assembly in the prior art pushes the embolic coil After advancing out of the catheter and into the blood vessel, it is difficult to withdraw the embolic coil, and it is also difficult to reposition the embolic coil.
发明内容Contents of the invention
本发明的目的在于提供一种推送组件及医用装置,利用该推送组件推送医用植入物时,在医用植入物进入血管后仍可以进行回收并重新定位,有利于提高治疗效果。The purpose of the present invention is to provide a push assembly and a medical device. When the push assembly is used to push the medical implant, the medical implant can still be recovered and repositioned after entering the blood vessel, which is beneficial to improve the treatment effect.
为实现上述目的,本发明提供了一种推杆组件,包括:To achieve the above object, the present invention provides a push rod assembly, comprising:
推杆,具有轴向贯通的第一内腔;The push rod has a first inner cavity axially penetrated;
限位机构,包括第一子限位机构和第二子限位机构;所述第一子限位机 构上形成有第一限位区,并还包括第一挡部,所述第一挡部设置于所述第一限位区的近端,且所述第一挡部上设有与所述第一限位区连通的第一通孔;所述第二子限位机构连接于所述推杆的远端;以及,The limiting mechanism includes a first sub-limiting mechanism and a second sub-limiting mechanism; the first sub-limiting mechanism is formed with a first limiting area, and also includes a first stop, the first stop It is arranged at the proximal end of the first limiting area, and the first stop part is provided with a first through hole communicating with the first limiting area; the second sub-limiting mechanism is connected to the the distal end of the push rod; and,
控制杆;Controller;
所述推杆组件被配置为当所述控制杆的远端穿过所述第一内腔及所述第一通孔,并与所述第二子限位机构的远端部分连接,且将所述第二子限位机构的远端部分限制于所述第一限位区内时,所述推杆组件处于锁定位置;当所述控制杆沿所述第一通孔的轴向移动,并允许所述第二子限位机构的远端部分脱离所述第一限位区时,所述推杆组件处于解锁位置。The push rod assembly is configured such that when the distal end of the control rod passes through the first inner cavity and the first through hole, and is connected with the distal end portion of the second sub-limiting mechanism, and will When the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in the locked position; when the control rod moves along the axial direction of the first through hole, And when the distal part of the second sub-limiting mechanism is allowed to break away from the first limiting area, the push rod assembly is in the unlocked position.
可选地,所述第一限位区形成于所述第一子限位机构的侧面上,并沿径向向内凹陷;所述第二子限位机构的侧面上形成有沿径向向内凹陷的第二限位区,并还包括第二挡部,所述第二挡部设置于所述第二限位区的远端并构成所述第二子限位机构的远端部分,所述第二挡部上设有第二通孔,且所述第二通孔、所述第二限位区及所述第一内腔依次连通;Optionally, the first limiting area is formed on the side of the first sub-limiting mechanism, and is radially inwardly recessed; the side of the second sub-limiting mechanism is formed with a The second limiting area is recessed inside, and also includes a second stopper, the second stopper is arranged at the distal end of the second limiting area and constitutes the distal part of the second sub-limiting mechanism, A second through hole is provided on the second blocking portion, and the second through hole, the second limiting area and the first inner cavity are sequentially communicated with each other;
当所述推杆组件处于所述锁定位置时,所述控制杆还将所述第一挡部限制于所述第二限位区内,且所述控制杆的远端还穿过所述第二通孔;当所述控制杆沿由远端向近端的方向移动并使所述控制杆的远端位于所述第二限位区的近端侧时,所述推杆组件处于所述解锁位置,并还允许所述第一挡部脱离所述第二限位区。When the push rod assembly is in the locked position, the control rod also constrains the first stop part in the second limiting area, and the distal end of the control rod also passes through the first Two through holes; when the control rod moves in the direction from the distal end to the proximal end and the distal end of the control rod is located on the proximal side of the second limiting area, the push rod assembly is in the The unlocked position also allows the first blocking part to disengage from the second limiting area.
可选地,所述第二子限位机构还包括第一接合部,所述第一接合部位于所述第二限位区的近端,并与所述推杆的远端连接;所述第一接合部上设有第三通孔,所述第三通孔与所述第一内腔及所述第二限位区连通,并用于供所述控制杆的远端贯穿。Optionally, the second sub-limiting mechanism further includes a first engaging portion, the first engaging portion is located at the proximal end of the second limiting area and is connected to the distal end of the push rod; A third through hole is provided on the first joint portion, and the third through hole communicates with the first inner cavity and the second limiting area, and is used for the distal end of the control rod to pass through.
可选地,所述推杆组件用于可活动地穿设于一导管的第二内腔中,以将一医用植入物输送至目标位置。Optionally, the push rod assembly is used to movably pass through the second lumen of a catheter, so as to deliver a medical implant to a target position.
可选地,所述第一挡部的宽度与所述第二挡部的宽度之和与所述第二内腔的直径的比值范围为1~1.5。Optionally, the ratio of the sum of the width of the first blocking portion and the width of the second blocking portion to the diameter of the second inner cavity ranges from 1 to 1.5.
可选地,所述第二子限位机构包括形变部,所述形变部环绕所述控制杆 布置,且所述形变部的近端连接于所述推杆上的第一连接点处,所述形变部的远端连接于所述控制杆上的第二连接点处;所述形变部的远端部分即为所述第二子限位机构的远端部分;Optionally, the second sub-limiting mechanism includes a deformation part, the deformation part is arranged around the control rod, and the proximal end of the deformation part is connected to the first connection point on the push rod, so The distal end of the deformation part is connected to the second connection point on the control rod; the distal part of the deformation part is the distal part of the second sub-limiting mechanism;
所述推杆组件被配置当所述形变部的远端部分穿过所述第一通孔并位于所述第一限位区,且所述第二连接点到所述第一连接点的轴向距离小于预定值时,所述形变部的远端部分径向扩张至径向最大尺寸大于所述第一通孔的孔径,使得所述形变部的远端部分被限制在所述第一限位区内,当所述控制杆沿由近端向远端的方向移动,并使所述第二连接点到所述第一连接点的轴向距离等于所述预定值时,所述形变部的远端部分径向收缩至径向尺寸小于或等于所述第一通孔的孔径,以允许所述形变部的远端部分脱离所述第一限位区。The push rod assembly is configured when the distal portion of the deformation part passes through the first through hole and is located in the first limiting area, and the axis between the second connection point and the first connection point When the distance in the radial direction is less than a predetermined value, the distal end portion of the deformation portion is radially expanded to a radial maximum dimension larger than the diameter of the first through hole, so that the distal end portion of the deformation portion is restricted within the first limit. In the position zone, when the control rod moves in the direction from the proximal end to the distal end and makes the axial distance from the second connection point to the first connection point equal to the predetermined value, the deformation part The distal end portion of the deformation portion is radially contracted to a radial dimension smaller than or equal to the diameter of the first through hole, so as to allow the distal end portion of the deformation portion to break away from the first limiting area.
可选地,所述形变部包括多个弹片,多个所述弹片环绕所述控制杆依次布置;或者,所述形变部为弹性套,并套设在所述控制杆的外部。Optionally, the deformation part includes a plurality of elastic pieces, and the plurality of elastic pieces are sequentially arranged around the control rod; or, the deformation part is an elastic sleeve, and is sleeved on the outside of the control rod.
可选地,所述第一子限位机构具有第三内腔,所述第三内腔构成所述第一限位区。Optionally, the first sub-limiting mechanism has a third inner cavity, and the third inner cavity constitutes the first limiting area.
可选地,所述推杆由丝材编织成型。Optionally, the push rod is braided from wire.
可选地,所述控制杆的直径为所述第一通孔的孔径的50%~60%。Optionally, the diameter of the control rod is 50%-60% of the diameter of the first through hole.
可选地,第一子限位机构还包括第二接合部,设置于所述第一限位区的远端。Optionally, the first sub-limiting mechanism further includes a second engaging portion disposed at a distal end of the first limiting area.
为实现上述目的,本发明还提供了一种医用装置,包括医用植入物和如前任一项所述的推杆组件,所述第一子限位机构用于连接于所述医用植入物的近端。To achieve the above object, the present invention also provides a medical device, including a medical implant and the push rod assembly as described in any one of the preceding items, the first sub-limiting mechanism is used to connect to the medical implant the proximal end.
可选地,所述医用植入物包括栓塞弹簧圈。Optionally, the medical implant includes an embolic coil.
与现有技术相比,本发明的推送组件及医用装置具有如下优点:Compared with the prior art, the pushing assembly and the medical device of the present invention have the following advantages:
前述的医用装置包括医用植入物和推杆组件;所述推杆组件包括推杆、限位机构和控制杆;所述推杆具有轴向贯通的第一内腔;所述限位机构包括第一子限位机构和第二子限位机构;所述第一子限位机构连接于所述医用植入物的近端,其上形成有第一限位区,并还包括第一挡部,所述第一挡部设 置于所述第一限位区的近端,且所述第一挡部上设有与所述第一限位区连通的第一通孔;所述第二子限位机构连接于所述推杆的远端;所述推杆组件被配置为当所述控制杆的远端穿过所述第一内腔及所述第一通孔,并与所述第二子限位机构的远端部分连接且将所述第二子限位机构的远端部分限制于所述第一限位区内时,所述推杆组件处于锁定位置;当所述控制杆沿所述第一通孔的轴向移动并允许所述第二子限位机构的远端部分脱离所述第一限位区时,所述推杆组件处于解锁位置。也就是说,在利用所述推杆组件推送所述医用植入物时,只要所述推杆组件处于所述锁定位置,所述医用植入物就受到所述推杆的控制,即使所述医用植入物已进入血管内,仍可以通过所述推杆进行回收并重新对其定位,提高所述医用植入物的定位准确性。不仅于此,通过所述控制杆与所述限位机构的配合,还避免了在推送所述医用植入物通过血管弯曲部位时发生第一子限位机构和所述第二子限位机构提前分离的情况,提高推送杆的使用可靠性。The foregoing medical device includes a medical implant and a push rod assembly; the push rod assembly includes a push rod, a limit mechanism and a control rod; the push rod has a first inner cavity axially penetrated; the limit mechanism includes The first sub-limiting mechanism and the second sub-limiting mechanism; the first sub-limiting mechanism is connected to the proximal end of the medical implant, and a first limiting area is formed thereon, and also includes a first stop part, the first stop part is arranged at the proximal end of the first limit area, and the first stop part is provided with a first through hole communicating with the first limit area; the second The sub-limiting mechanism is connected to the distal end of the push rod; the push rod assembly is configured such that when the distal end of the control rod passes through the first inner cavity and the first through hole, and is connected with the When the distal part of the second sub-limiting mechanism is connected and the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in a locked position; when the control When the rod moves axially along the first through hole and allows the distal portion of the second sub-limiting mechanism to disengage from the first limiting area, the push rod assembly is in the unlocked position. That is to say, when the medical implant is pushed by the push rod assembly, as long as the push rod assembly is in the locked position, the medical implant is controlled by the push rod, even if the Once the medical implant has entered the blood vessel, it can still be recovered and repositioned through the push rod, so as to improve the positioning accuracy of the medical implant. Not only that, through the cooperation of the control rod and the limiting mechanism, it is also avoided that the first sub-limiting mechanism and the second sub-limiting mechanism occur when the medical implant is pushed through the curved part of the blood vessel. In the case of early separation, the reliability of the push rod is improved.
附图说明Description of drawings
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:The accompanying drawings are used to better understand the present invention, and do not constitute improper limitations to the present invention. in:
图1是本发明根据实施例一所提供的推杆组件的结构示意图,图示中第一子限位机构与医用植入物连接;Fig. 1 is a schematic structural view of the push rod assembly provided according to Embodiment 1 of the present invention, in which the first sub-limiting mechanism is connected to the medical implant;
图2是本发明根据实施例一所提供的推杆组件的第一子限位机构的结构示意图;Fig. 2 is a schematic structural view of the first sub-limiting mechanism of the push rod assembly provided according to Embodiment 1 of the present invention;
图3是本发明根据实施例一所提供的推杆组件的第一子限位机构与医用植入物的连接关系示意图;Fig. 3 is a schematic diagram of the connection relationship between the first sub-limiting mechanism of the push rod assembly and the medical implant according to Embodiment 1 of the present invention;
图4是本发明根据实施例一所提供的推杆组件的第二子限位机构的结构示意图;Fig. 4 is a schematic structural view of the second sub-limiting mechanism of the push rod assembly provided according to Embodiment 1 of the present invention;
图5是本发明根据实施例一所提供的推杆组件的第二子限位机构、推杆及控制杆的连接关系示意图;Fig. 5 is a schematic diagram of the connection relationship between the second sub-limiting mechanism, the push rod and the control rod of the push rod assembly provided by the first embodiment of the present invention;
图6是本发明根据实施例一所提供的推杆组件的使用场景示意图,图示中推杆组件处于锁定位置,且医用植入物的近端位于导管的第二内腔中;Fig. 6 is a schematic view of the use scene of the push rod assembly provided according to the first embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located in the second lumen of the catheter;
图7是本发明根据实施例一所提供的推杆组件的使用场景示意图,图示中医用植入物的近端位于导管外部,且推杆组件仍处于锁定位置;Fig. 7 is a schematic diagram of the use scene of the push rod assembly provided according to the first embodiment of the present invention, which shows that the proximal end of the medical implant is located outside the catheter, and the push rod assembly is still in the locked position;
图8是本发明根据实施例一所提供的推杆组件的使用场景示意图,图示中医用植入物的近端位于导管外部,推杆组件处于解锁位置,第一挡部脱离能够第一限位区,第二挡部能够脱离第二限位区;Fig. 8 is a schematic view of the use scene of the push rod assembly provided according to Embodiment 1 of the present invention. It shows that the proximal end of the medical implant is located outside the catheter, the push rod assembly is in the unlocked position, and the first stop can be disengaged from the first limit. Position zone, the second gear can break away from the second limit zone;
图9是本发明根据实施例二所提供的推杆组件的使用场景示意图,图示中推杆组件处于锁定位置,且医用植入物的近端位于导管的第二内腔中;Fig. 9 is a schematic diagram of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located in the second lumen of the catheter;
图10是本发明根据实施例二所提供的推杆组件的使用场景示意图,图示中推杆组件处于锁定位置,且医用植入物的近端位于导管外部;Fig. 10 is a schematic diagram of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the locked position, and the proximal end of the medical implant is located outside the catheter;
图11是本发明根据实施例二所提供的推杆组件的使用场景示意图,图示中推杆组件处于解锁位置,且第二子限位机构的远端部分位于所述第一限位区内;Fig. 11 is a schematic view of the use scene of the push rod assembly provided according to the second embodiment of the present invention, in which the push rod assembly is in the unlocked position, and the distal part of the second sub-limiting mechanism is located in the first limiting area ;
图12是本发明根据实施例二所提供的推杆组件的使用场景示意图,图示中推杆组件处于解锁位置,且第二子限位机构的远端部分脱离第一限位区。Fig. 12 is a schematic view of the use scene of the push rod assembly provided by the second embodiment of the present invention. In the illustration, the push rod assembly is in the unlocked position, and the distal part of the second sub-limiting mechanism is out of the first limiting area.
[附图标记说明如下]:[the reference signs are explained as follows]:
1-导管;1 - conduit;
10-栓塞弹簧圈;10-Embolic coil;
100-推杆,200-限位机构,210-第一子限位机构,211-第一限位区,212-第一挡部,213-第一通孔,214-第二接合部,215-第四通孔,220-第二子限位机构,221-第二限位区,222-第二挡部,223-第二通孔,224-第一接合部,225-第三通孔,300-控制杆。100-push rod, 200-limiting mechanism, 210-first sub-limiting mechanism, 211-first limiting area, 212-first stop, 213-first through hole, 214-second joint, 215 - the fourth through hole, 220 - the second sub-limiting mechanism, 221 - the second limiting area, 222 - the second blocking part, 223 - the second through hole, 224 - the first joint part, 225 - the third through hole , 300-control lever.
具体实施方式Detailed ways
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构 想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。Embodiments of the present invention are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation modes, and various modifications or changes can be made to the details in this specification based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the diagrams provided in this embodiment are only schematically illustrating the basic idea of the present invention, and only the components related to the present invention are shown in the diagrams rather than the number, shape and shape of the components in actual implementation. Dimensional drawing, the type, quantity and proportion of each component can be changed arbitrarily during actual implementation, and the component layout type may also be more complicated.
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施例中部分或全部的技术特征的组合,借此增加本发明实施时的弹性。In addition, each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数形式“多个”包括两个以上的对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。As used in this specification, the singular forms "a", "an" and "the" include plural objects, and the plural form "a plurality" includes two or more objects, unless the content clearly states otherwise. As used in this specification, the term "or" is generally used in the sense including "and/or", unless the content clearly indicates otherwise, and the terms "install", "connect" and "connect" should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
本发明的核心思想在于提供一种推杆组件,该推杆组件用于与一医用植入物连接,并沿一导管将所述医用植入物推送至患者体内的目标区域的目标位置后进行释放。所述推杆组件包括推杆、限位机构和控制杆。其中,所述推杆具有轴向贯通的第一内腔;所述限位机构包括第一子限位机构和第二子限位机构。所述第一子限位机构用于连接于所述医用植入物的近端,所述第一子限位机构上形成有第一限位区,并还包括第一挡部,所述第一挡部设置 于所述第一限位区的近端,且所述第一挡部上设有与所述第一限位区连通的第一通孔。所述第二子限位机构连接于所述推杆的远端。所述推杆组件被配置为当所述控制杆的远端穿过所述第一内腔及所述第一通孔并与所述第二子限位机构的远端部分连接,且将所述第二子限位机构的远端部分限制在所述第一限位区内时,所述推杆组件处于锁定状态,此时所述推杆通过所述限位机构与所述医用植入物保持连接。当所述控制杆沿所述第一通孔的轴向移动,并允许所述第二子限位机构的远端部分脱离所述第一限位区时,所述推杆组件处于解锁状态,此情形下所述医用植入物与所述推杆解除连接或允许两者解除连接。也就是说,所述推杆组件在推送所述医用植入物的过程中,只要使所述推杆组件保持在锁定位置,即使所述医用植入物已经被完全地推出所述导管(即所述医用植入物的近端已经脱离所述导管),仍可以利用所述推杆回收所述医用植入物并对所述医用植入物的位置进行调整,以提高所述医用植入物释放时的定位准确性,有利于改善治疗效果。本发明实施例中,所述医用植入物通常是指栓塞弹簧圈。The core idea of the present invention is to provide a push rod assembly, which is used to connect with a medical implant, and push the medical implant to the target position of the target area in the patient's body along a catheter to carry out freed. The push rod assembly includes a push rod, a limit mechanism and a control rod. Wherein, the push rod has a first inner cavity axially penetrated; the limiting mechanism includes a first sub-limiting mechanism and a second sub-limiting mechanism. The first sub-limiting mechanism is used to connect to the proximal end of the medical implant, the first sub-limiting mechanism is formed with a first limiting area, and also includes a first stop portion, the first sub-limiting mechanism A blocking portion is arranged at the proximal end of the first limiting area, and a first through hole communicating with the first limiting area is formed on the first blocking portion. The second sub-limiting mechanism is connected to the distal end of the push rod. The push rod assembly is configured such that when the distal end of the control rod passes through the first inner chamber and the first through hole and is connected with the distal end portion of the second sub-limiting mechanism, and the When the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in a locked state, and at this time the push rod passes through the limiting mechanism and the medical implant Things stay connected. When the control rod moves axially along the first through hole and allows the distal part of the second sub-limiting mechanism to break away from the first limiting area, the push rod assembly is in an unlocked state, In this case the medical implant is decoupled from the push rod or both are allowed to be decoupled. That is to say, when the push rod assembly is pushing the medical implant, as long as the push rod assembly is kept at the locked position, even if the medical implant has been completely pushed out of the guide tube (i.e. The proximal end of the medical implant has broken away from the catheter), the push rod can still be used to reclaim the medical implant and adjust the position of the medical implant to improve the medical implant The positioning accuracy of drug release is conducive to improving the therapeutic effect. In the embodiment of the present invention, the medical implant generally refers to an embolism coil.
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。附图中相同或相似的附图标记代表相同或相似的部件。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings. It should be noted that all the drawings are in a very simplified form and use imprecise scales, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.
在本文中,术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向,尽管“近端”、“远端”并非是限制性的,但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端,而“远端”通常是指首先进入患者体内的一端。In this context, the terms "proximal", "distal" refer to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although "proximal", "distal ” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the practitioner during normal operation, and “distal” generally refers to the end that enters the patient first.
<实施例一><Example 1>
图1示出了本实施例所提供的推杆组件的结构示意图。如图1所示,所 述推杆组件包括推杆100、限位机构200和控制杆300。所述推杆100具有轴向贯通的第一内腔。所述限位机构200包括第一子限位机构210和第二子限位机构220。其中,所述第一子限位机构210上设有第一限位区211,并还包括第一挡部212,所述第一挡部212设置于所述第一限位区211的近端,且所述第一挡部212上设有与所述第一限位区211连通的第一通孔213。所述第二子限位机构220连接于所述推杆100的远端。所述控制杆300用于可活动地穿设在所述第一内腔及所述第一通孔213中。Fig. 1 shows a schematic structural view of the push rod assembly provided by this embodiment. As shown in FIG. 1 , the push rod assembly includes a push rod 100, a limiting mechanism 200 and a control rod 300. The push rod 100 has a first inner cavity axially penetrating. The limiting mechanism 200 includes a first sub-limiting mechanism 210 and a second sub-limiting mechanism 220 . Wherein, the first sub-limiting mechanism 210 is provided with a first limiting area 211, and also includes a first blocking portion 212, and the first blocking portion 212 is arranged at the proximal end of the first limiting area 211. , and the first stop portion 212 is provided with a first through hole 213 communicating with the first limiting area 211 . The second sub-limiting mechanism 220 is connected to the distal end of the push rod 100 . The control rod 300 is configured to be movably passed through the first inner cavity and the first through hole 213 .
所述推杆组件的所述第一子限位机构210用于连接于一医用植入物例如栓塞弹簧圈10的近端,并用于沿一导管1的第二内腔将所述栓塞弹簧圈10推送并释放至患者体内的目标血管的目标位置处。The first sub-limiting mechanism 210 of the push rod assembly is used to be connected to the proximal end of a medical implant such as the embolic coil 10, and is used to push the embolic coil along the second lumen of a catheter 1. 10 is pushed and released to the target location in the target blood vessel in the patient.
所述推杆组件具有锁定位置和解锁位置。当所述推杆组件处于所述锁定位置时,所述第二子限位机构220的远端部分位于所述第一限位区211内部,且所述控制杆300的远端穿过所述第一内腔及所述第一通孔213,并还与所述第二子限位机构220的远端部分连接,以将所述第二子限位机构220的远端部分限制在所述第一限位区211内,并阻止所述第二子限位机构220的远端部分脱离所述第一限位区,使得所述第二子限位机构220与所述第一子限位机构210保持连接,从而施术者可通过所述推杆100控制所述栓塞弹簧圈10,并随时调整所述栓塞弹簧圈10的位置。当所述控制杆300沿所述第一通孔213的轴向移动至允许所述第二子限位机构220的远端部分脱离所述第一限位区211位置时,所述推杆组件处于所述解锁位置。此时所述第二子限位机构220与所述第一子限位机构210能够解除连接,进而所述栓塞弹簧圈10(携带所述第一子限位机构210一起)能够脱离所述推杆100。该推杆组件的优点在于,只要使所述推杆组件保持在所述锁定位置,在释放所述栓塞弹簧圈10的过程中,施术者一旦发现所述栓塞弹簧圈10的位置不佳,即使所述栓塞弹簧圈10 已经被完全推出所述导管1,仍可以通过操作所述推杆组件将所述栓塞弹簧圈10回收至所述导管1内并重新调整所述栓塞弹簧圈10的位置后再进行释放,有利于提高所述栓塞弹簧圈10的定位准确性,改善治疗效果。不仅于此,在血管弯曲位置,所述导管1的横截面会由圆形变形为椭圆形,导致所述导管1的横截面的某一方向的径向尺寸增大。所述推杆组件推送所述栓塞弹簧圈10经过该弯曲位置时,在所述控制杆300的存在下使得所述推杆组件处于所述锁定位置,避免所述第一子限位机构210和所述第二子限位机构220在弯曲区域处因所述导管1的横截面的径向尺寸的变化而发生提前分离的情况(即所述第二子限位机构220的远端部分脱离所述第一限位区211),提高推杆组件的使用可靠性。The push rod assembly has a locked position and an unlocked position. When the push rod assembly is in the locked position, the distal end portion of the second sub-limiting mechanism 220 is located inside the first limiting area 211, and the distal end of the control rod 300 passes through the The first inner chamber and the first through hole 213 are also connected to the distal part of the second sub-limiting mechanism 220, so that the distal part of the second sub-limiting mechanism 220 is limited to the inside the first limiting area 211, and prevent the distal part of the second sub-limiting mechanism 220 from breaking away from the first limiting area, so that the second sub-limiting mechanism 220 and the first sub-limiting mechanism 220 The mechanism 210 remains connected so that the operator can control the embolic coil 10 through the push rod 100 and adjust the position of the embolic coil 10 at any time. When the control rod 300 moves axially along the first through hole 213 to a position allowing the distal end portion of the second sub-limiting mechanism 220 to disengage from the first limiting area 211, the push rod assembly in the unlocked position. At this time, the second sub-limiting mechanism 220 can be disconnected from the first sub-limiting mechanism 210, and then the embolism coil 10 (carrying the first sub-limiting mechanism 210) can be separated from the push button. Rod 100. The advantage of this push rod assembly is that as long as the push rod assembly is kept at the locking position, in the process of releasing the embolic coil 10, once the operator finds that the position of the embolic coil 10 is not good, Even if the embolic coil 10 has been completely pushed out of the catheter 1, the embolic coil 10 can still be recovered into the catheter 1 and the position of the embolic coil 10 can be readjusted by operating the push rod assembly After releasing, it is beneficial to improve the positioning accuracy of the embolic coil 10 and improve the therapeutic effect. Not only that, at the bending position of the blood vessel, the cross-section of the catheter 1 will be deformed from a circular shape to an ellipse, resulting in an increase in the radial dimension of the cross-section of the catheter 1 in a certain direction. When the push rod assembly pushes the embolism coil 10 through the bending position, the push rod assembly is in the locked position under the presence of the control rod 300, avoiding the first sub-limit mechanism 210 and The second sub-limiting mechanism 220 is separated in advance due to the change of the radial dimension of the cross-section of the catheter 1 at the bending area (that is, the distal end portion of the second sub-limiting mechanism 220 breaks away from the The above-mentioned first limiting area 211) improves the reliability of the push rod assembly.
优选地,所述推杆100可以是由金属丝螺旋编织而成的管状结构或者由金属管切割而成的管状结构,其具有良好的柔顺性和过弯性能,减少推送过程中发生阻滞、打折等情况的发生概率。所述控制杆300通常由单股金属丝构成,其直径可为所述第一通孔213的直径的50%~60%,这样不仅可使得所述推杆组件具有较好的整体柔顺性,还使得所述控制杆300在径向上的移动空间较小,进而减小所述第一子限位机构210及所述栓塞弹簧圈10在推送时晃动幅度。Preferably, the push rod 100 can be a tubular structure formed by helically braiding metal wires or cut from a metal tube, which has good flexibility and cornering performance, and can reduce stagnation, Probability of occurrence of discounts etc. The control rod 300 is generally made of a single strand of metal wire, and its diameter may be 50% to 60% of the diameter of the first through hole 213, which not only makes the push rod assembly have better overall flexibility, It also makes the movement space of the control rod 300 smaller in the radial direction, thereby reducing the shaking range of the first sub-limit mechanism 210 and the embolism coil 10 when pushing.
请参考图2,所述第一子限位机构210的侧面上形成有沿径向向内凹陷的凹槽,该凹槽即可作为所述第一限位区211。进一步地,所述第一子限位机构210还包括第二接合部214,所述第二接合部214设置在所述第一限位区211的远端,并构成所述凹槽的远端侧壁。所述第二接合部214用于与所述栓塞弹簧圈10的近端连接(如图3所示)。本实施例中,可通过在一圆柱体上的中间区域去除一部分材料以同时形成所述第一挡部212、所述第一限位区211和所述第二接合部214。可理解的是,当所述圆柱体的横截面大于所述栓塞弹 簧圈10的横截面时,可使所述第二接合部214的远端形成为横截面由近端向远端逐渐减小的锥形头,且所述锥形头的远端端面与所述栓塞弹簧圈10的横截面相匹配。此外,还优选所述第二接合部214上设有与所述第一限位区211及所述栓塞弹簧圈10的内腔相连通的第四通孔215。Please refer to FIG. 2 , a radially inwardly recessed groove is formed on the side of the first sub-limiting mechanism 210 , and the groove can serve as the first limiting area 211 . Further, the first sub-limiting mechanism 210 also includes a second engaging portion 214, the second engaging portion 214 is arranged at the distal end of the first limiting area 211, and constitutes the distal end of the groove side wall. The second engaging portion 214 is used to connect with the proximal end of the embolic coil 10 (as shown in FIG. 3 ). In this embodiment, the first blocking portion 212 , the first limiting area 211 and the second joint portion 214 can be formed simultaneously by removing a part of material in the middle area of a cylinder. It can be understood that when the cross-section of the cylinder is larger than the cross-section of the embolic coil 10, the distal end of the second engaging portion 214 can be formed such that the cross-section gradually decreases from the proximal end to the distal end. The conical head, and the distal end surface of the conical head matches the cross section of the embolic coil 10 . In addition, preferably, the second joint portion 214 is provided with a fourth through hole 215 communicating with the first limiting area 211 and the inner cavity of the embolic coil 10 .
请参考图4,所述第二子限位机构220的侧面上形成有沿径向向内凹陷的第二限位区221,所述第二限位区221与所述推杆100的第一内腔连通。所述第二子限位机构220还包括第二挡部222,所述第二挡部222设置在所述第二限位区221的远端,该第二挡部222构成所述第二限位机构220的远端部分。所述第二挡部222上设有第二通孔223,所述第二通孔与所述第二限位区221连通。进一步地,所述第二子限位机构220还包括第一接合部224,设置在所述第二限位区221的近端,并与所述推杆100连接(如图5所示)。所述第一接合部224上设有第三通孔225,所述第三通孔225用于连通所述第一内腔和所述第二限位区221。类似于所述第一子限位机构210,所述第二子限位机构220也可通过在一圆柱体的中间区域去除一部分材料而同时形成所述第二挡部222、所述第二限位区221和所述第一接合部224。Please refer to FIG. 4 , on the side of the second sub-limiting mechanism 220 is formed a second limiting area 221 radially inwardly recessed, and the second limiting area 221 is aligned with the first limiting area of the push rod 100 . The lumen is connected. The second sub-limiting mechanism 220 also includes a second stopper 222, the second stopper 222 is arranged at the distal end of the second limiter area 221, and the second stopper 222 constitutes the second limiter. The distal portion of the bit mechanism 220. The second blocking portion 222 is provided with a second through hole 223 , and the second through hole communicates with the second limiting area 221 . Further, the second sub-limiting mechanism 220 also includes a first joint portion 224, which is arranged at the proximal end of the second limiting area 221 and connected with the push rod 100 (as shown in FIG. 5 ). The first joint portion 224 is provided with a third through hole 225 , and the third through hole 225 is used to communicate with the first inner cavity and the second limiting area 221 . Similar to the first sub-limiting mechanism 210, the second sub-limiting mechanism 220 can also simultaneously form the second stopper 222 and the second limiting mechanism by removing a part of material in the middle area of a cylinder. The bit area 221 and the first bonding portion 224 .
装配所述推杆组件及所述栓塞弹簧圈10,并使所述推杆组件处于所述锁定位置时,所述第一挡部212位于所述第二限位区221内,所述第二挡部222(即所述第二子限位机构220的远端部分)位于所述第一限位区211内,且所述控制杆300的远端依次穿过所述第一内腔、所述第三通孔225、所述第一通孔213、所述第二通孔223,还优选穿过所述第四通孔215,从而将所述第二挡部222限制在所述第一限位区211内,以及将所述第一挡部212限制在所述第二限位区221内。可选地,所述控制杆300的远端还可伸入所述栓塞弹簧圈10的内腔。为方便组装,本实施例中,优选所述第一通孔213及所述第四通孔215沿所述第一子限位机构210的轴向延伸,所述第二通孔223及 所述第三通孔225沿所述第二子限位机构220的轴向延伸。When the push rod assembly and the plug spring ring 10 are assembled, and the push rod assembly is in the locked position, the first stopper 212 is located in the second limiting area 221, and the second The blocking part 222 (that is, the distal part of the second sub-limiting mechanism 220) is located in the first limiting area 211, and the distal end of the control rod 300 passes through the first inner cavity, the The third through hole 225, the first through hole 213, the second through hole 223, and preferably through the fourth through hole 215, so that the second blocking portion 222 is limited in the first within the limiting area 211 , and limit the first blocking portion 212 within the second limiting area 221 . Optionally, the distal end of the control rod 300 can also extend into the lumen of the embolic coil 10 . For the convenience of assembly, in this embodiment, preferably, the first through hole 213 and the fourth through hole 215 extend along the axial direction of the first sub-limiting mechanism 210, and the second through hole 223 and the The third through hole 225 extends along the axial direction of the second sub-limiting mechanism 220 .
利用所述推杆组件沿所述导管1的第二内腔将所述栓塞弹簧圈10推送至体内的目标位置(此时所述栓塞弹簧圈10已完全位于所述导管1的外部),施术者可沿由远端向近端的方向拉动所述控制杆300,当所述控制杆300回撤至其远端处于所述第二限位区221的近端侧时,所述推杆组件处于所述解锁位置,此时所述第二挡部222可脱离所述第一限位区211,所述第一挡部212可脱离所述第二限位区221,所述栓塞弹簧圈10携带所述第一子限位机构210一起脱离所述推杆100。Use the push rod assembly to push the embolic coil 10 to the target position in the body along the second lumen of the catheter 1 (at this time, the embolic coil 10 is completely located outside the catheter 1), and The operator can pull the control rod 300 in the direction from the distal end to the proximal end, and when the control rod 300 is retracted until its distal end is on the proximal side of the second limiting area 221, the push rod When the assembly is in the unlocked position, the second stopper 222 can break away from the first limiting area 211, the first stopper 212 can break away from the second limiting area 221, and the embolism coil 10 is separated from the push rod 100 together with the first sub-limiting mechanism 210 .
可选地,本实施例中,所述第一挡部212的宽度与所述第二挡部222的宽度之和与所述导管1的第二内腔的直径的比值为(1~1.5),例如该比值为1.1、1.2、1.3或1.4等。如此设置,一方面可确保所述推杆组件可推送所述栓塞弹簧圈10沿所述第二内腔移动,另一方面也使所述第一子限位机构210和所述第二子限位机构220具有足够的强度。可理解,所述第一挡部212的宽度即为所述第一限位区211的深度,所述第二挡部222的宽度为所述第二限位区221的深度,所述第一限位区211及所述第二限位区221的深度是指相应的限位区在所述推杆组件的径向上的尺寸。Optionally, in this embodiment, the ratio of the sum of the width of the first blocking portion 212 and the width of the second blocking portion 222 to the diameter of the second lumen of the catheter 1 is (1˜1.5) , for example the ratio is 1.1, 1.2, 1.3 or 1.4 etc. So set, on the one hand, it can ensure that the push rod assembly can push the embolism coil 10 to move along the second inner cavity; Bit mechanism 220 has sufficient strength. It can be understood that the width of the first blocking portion 212 is the depth of the first limiting area 211, the width of the second blocking portion 222 is the depth of the second limiting area 221, and the first The depth of the limiting area 211 and the second limiting area 221 refers to the size of the corresponding limiting area in the radial direction of the push rod assembly.
接下去介绍所述推杆组件推送并释放所述栓塞弹簧圈10的过程。Next, the process of pushing and releasing the embolism coil 10 by the push rod assembly will be described.
首先,组装所述推杆组件及所述栓塞弹簧圈10,并使所述推杆组件处于所述锁定位置。Firstly, the push rod assembly and the embolism coil 10 are assembled, and the push rod assembly is in the locked position.
然后,利用鞘管将所述栓塞弹簧圈10导入预先植入患者体内的所述导管1的第二内腔中。Then, the embolic coil 10 is introduced into the second lumen of the catheter 1 pre-implanted in the patient's body by using a sheath.
之后,施术者在所述推杆100的近端向所述推杆组件施加推送力,并沿所述导管1的所述第二内腔将所述栓塞弹簧圈10推送至体内的目标位置,并将所述栓塞弹簧圈10推送至所述导管1的外部(如图6及图7所示),当所 述栓塞弹簧圈10已完全位于所述导管1的外部时(如图7所示),若所述栓塞弹簧圈10已经准确定位,施术者可在所述控制杆300的近端施加回撤力,以使所述控制杆300沿由远端向近端的方向移动至所述第二限位区221的近端侧例如移动至所述推杆100的所述第一内腔中(如图8所示),使得所述推杆组件处于所述解锁位置,此时所述第二挡部222可脱离所述第一限位区211,所述第一挡部212可脱离所述第二限位区221,以实现所述栓塞弹簧圈10的释放。在将所述推杆组件切换至所述解锁位置之前,若所述栓塞弹簧圈10的位置偏离所述目标位置,施术者可在所述推杆100的近端施加回撤力,以将所述栓塞弹簧圈10回收至所述第二内腔中,并在调整所述栓塞弹簧圈10的位置后重新进行释放。Afterwards, the operator applies a pushing force to the push rod assembly at the proximal end of the push rod 100, and pushes the embolic coil 10 to the target position in the body along the second lumen of the catheter 1 , and push the embolic coil 10 to the outside of the catheter 1 (as shown in FIG. 6 and FIG. 7 ), when the embolic coil 10 is completely outside the catheter 1 (as shown in FIG. 7 shown), if the embolic coil 10 has been correctly positioned, the operator can apply a retraction force on the proximal end of the control rod 300, so that the control rod 300 moves from the distal end to the proximal end to The proximal side of the second limiting area 221 moves into the first inner cavity of the push rod 100 (as shown in FIG. 8 ), so that the push rod assembly is in the unlocked position, and at this time The second blocking portion 222 can disengage from the first limiting area 211 , and the first blocking portion 212 can disengage from the second limiting area 221 to realize the release of the embolic coil 10 . Before switching the push rod assembly to the unlocked position, if the position of the embolic coil 10 deviates from the target position, the operator can apply a retraction force on the proximal end of the push rod 100 to push the The embolic coil 10 is recovered into the second inner cavity, and released again after the position of the embolic coil 10 is adjusted.
进一步地,本实施例还提供了一种医用装置,包括所述医用植入物例如栓塞弹簧圈10和所述推杆组件,所述推杆组件的所述第一子限位机构210连接于所述医用植入物的近端。Further, this embodiment also provides a medical device, including the medical implant such as the embolic coil 10 and the push rod assembly, the first sub-limiting mechanism 210 of the push rod assembly is connected to The proximal end of the medical implant.
<实施例二><Example 2>
本实施例与实施例一的区别之处主要在于所述第二子限位机构的结构不同。请参考图9至图12,本实施例中,所述第二子限位机构220包括形变部,所述形变部环绕所述控制杆300布置,且所述形变部的近端连接于所述推杆100上的第一连接点处,所述形变部的远端连接于所述控制杆300上的第二连接点处。优选地,所述第一连接点位于所述推杆100的远端端部,所述第二连接点位于所述控制杆300的远端端部。如此,所述形变部的远端部分即为所述第二限位机构220的远端部分。The difference between this embodiment and the first embodiment mainly lies in the structure of the second sub-limiting mechanism. Please refer to FIG. 9 to FIG. 12 , in this embodiment, the second sub-limiting mechanism 220 includes a deformation part, the deformation part is arranged around the control rod 300, and the proximal end of the deformation part is connected to the At the first connection point on the push rod 100 , the distal end of the deformation part is connected to the second connection point on the control rod 300 . Preferably, the first connection point is located at the distal end of the push rod 100 and the second connection point is located at the distal end of the control rod 300 . In this way, the distal portion of the deformation portion is the distal portion of the second limiting mechanism 220 .
所述推杆组件被配置为当所述形变部的远端部分随所述控制杆300的远端一起穿过所述第一通孔213并位于所述第一限位区211内,且所述第二连 接点到所述第一连接点的轴向距离小于预定值时,所述形变部的远端部分沿径向扩张至该部分的最大径向尺寸大于所述第一通孔213的孔径,所述形变部的远端部分被限制在所述第一限位区211内,以使所述推杆组件处于所述锁定位置。当所述控制杆300由近端向远端移动至所述第二连接点到所述第一连接点的轴向距离等于所述预定值时,所述形变部的远端部分径向收缩至该部分的最大径向尺寸小于或等于所述第一通孔213的孔径,以允许所述形变部的远端部分沿由远端向近端的方向穿过所述第一通孔213而脱离所述第一限位区211,此时所述推杆组件处于所述解锁位置。可理解,所述形变部的径向尺寸是指所述形变部在所述第一子限位机构210的径向截面上的尺寸。以及,径向扩张与径向收缩的含义是相对而言的,所述形变部的远端部分的径向尺寸由小变大即为径向扩张,而该部分的径向尺寸由大变小即为径向收缩。The push rod assembly is configured such that when the distal end of the deformation portion passes through the first through hole 213 together with the distal end of the control rod 300 and is located in the first limiting area 211 , and the When the axial distance from the second connection point to the first connection point is less than a predetermined value, the distal portion of the deformation portion expands radially until the maximum radial dimension of this portion is greater than that of the first through hole 213 Aperture, the distal portion of the deformation part is restricted in the first limiting area 211, so that the push rod assembly is in the locking position. When the control rod 300 moves from the proximal end to the distal end until the axial distance from the second connection point to the first connection point is equal to the predetermined value, the distal portion of the deformation portion radially shrinks to The maximum radial dimension of this part is less than or equal to the diameter of the first through hole 213, so as to allow the distal part of the deformation part to pass through the first through hole 213 in the direction from the distal end to the proximal end and to be disengaged. The first limiting area 211, at this time, the push rod assembly is in the unlocked position. It can be understood that the radial size of the deformation portion refers to the size of the deformation portion on the radial section of the first sub-limiting mechanism 210 . And, the meanings of radial expansion and radial contraction are relative, the radial dimension of the distal part of the deformation part changes from small to large, that is, radial expansion, and the radial dimension of this part changes from large to small That is radial shrinkage.
在一些实现方式中,所述形变部包括弹性套,所述弹性套套设在所述控制杆300的外部。或者,所述形变部包括多个弹片,多个弹片围绕所述控制杆300布置,此情形下,所述预定值等于所述形变部在自然状态下的长度,所述自然状态是指所述形变部不受外力作用时的状态,处于所述自然状态的所述形变部的远端部分的径向尺寸小于或等于所述第一通孔213的孔径,以使形变部的该部分能够通过所述第一通孔213。当所述第二连接点与所述第一连接点之间的轴向距离小于所述预定值时,所述形变部的远端部分弯曲变形并径向扩张,当所述第二连接点与所述第一连接点之间的轴向距离等于所述预定值时,所述形变部的远端部分恢复至自然状态。在另一些实现方式中,所述形变部为自膨式结构,例如所述形变部可包括多根被预定型为弧形的杆体,多根杆体围绕所述控制杆300布置,且所述杆体的凹侧朝向所述控制杆300,在此所述预定值大于所述形变部处于自然状态下时在所述控制杆300的 轴向上的长度,当所述形变部处于所述自然状态时,所述形变部的远端部分的径向尺寸大于所述第一通孔213的孔径,这样一来,当所述推杆组件处于所述锁定位置时,所述形变部的杆体的远端部分仍呈弧形状态,以使整个所述形变部的远端部分呈灯笼状,而当所述推杆组件处于解锁位置时,所述杆体可被拉伸为直线形态。所述自膨式结构是指该结构件本身具有良好的回弹力,当其受到外部作用力时发生形变,当外部作用力被取消时,结构件可在其自身回弹力的作用下复原。通常所述自膨式结构可采用形状记忆合金制作而成。In some implementation manners, the deformation part includes an elastic sleeve, and the elastic sleeve is disposed on the outside of the control rod 300 . Alternatively, the deformation portion includes a plurality of elastic pieces arranged around the control rod 300 , in this case, the predetermined value is equal to the length of the deformation portion in a natural state, and the natural state refers to the When the deformation part is not subjected to external force, the radial dimension of the distal part of the deformation part in the natural state is smaller than or equal to the diameter of the first through hole 213, so that this part of the deformation part can pass through The first through hole 213 . When the axial distance between the second connection point and the first connection point is smaller than the predetermined value, the distal end portion of the deformation portion is bent and deformed and radially expanded, and when the second connection point and the first connection point are When the axial distance between the first connection points is equal to the predetermined value, the distal end portion of the deformation part returns to a natural state. In some other implementation manners, the deformation part is a self-expanding structure, for example, the deformation part may include a plurality of rods that are pre-shaped into an arc, and the plurality of rods are arranged around the control rod 300, and the rods The concave side of is facing the control rod 300, where the predetermined value is greater than the axial length of the control rod 300 when the deformation part is in the natural state, when the deformation part is in the natural state , the radial dimension of the distal portion of the deformation portion is larger than the diameter of the first through hole 213, so that when the push rod assembly is in the locked position, the distal end of the rod body of the deformation portion The part is still in an arc shape, so that the entire distal end of the deformation part is in the shape of a lantern, and when the push rod assembly is in the unlocked position, the rod body can be stretched into a straight shape. The self-expanding structure means that the structural member itself has good resilience, and it deforms when it is subjected to an external force, and when the external force is canceled, the structural member can recover under the action of its own resilience. Usually, the self-expanding structure can be made of shape memory alloy.
此外,本实施例中,所述第一子限位机构210的结构可与实施例一中完全相同,也可以不同。请继续参考图9至图12,图示中所述的第一子限位机构210为中空结构,其具有第三内腔,该第三内腔构成所述第一限位区211,该第一子限位机构210的所述第二接合部214上可不设置第四通孔。In addition, in this embodiment, the structure of the first sub-limiting mechanism 210 may be completely the same as that in Embodiment 1, or it may be different. Please continue to refer to FIG. 9 to FIG. 12 , the first sub-limiting mechanism 210 described in the illustration is a hollow structure, which has a third inner cavity, and the third inner cavity constitutes the first limiting area 211 . The second engaging portion 214 of a sub-limiting mechanism 210 may not be provided with a fourth through hole.
接下去介绍本实施例所提供的推杆组件推送所述医用植入物(即栓塞弹簧圈10)的过程。Next, the process of pushing the medical implant (ie, the embolic coil 10 ) by the push rod assembly provided in this embodiment will be described.
首先,组装所述推杆组件及所述栓塞弹簧圈10,并使所述推杆组件处于所述锁定位置。Firstly, the push rod assembly and the embolism coil 10 are assembled, and the push rod assembly is in the locked position.
之后,通过一鞘管将所述栓塞弹簧圈10导入已预先植入患者体内的所述导管1的第二内腔中。Afterwards, the embolic coil 10 is introduced into the second lumen of the catheter 1 that has been pre-implanted in the patient's body through a sheath.
然后施术者在所述推杆100的近端向所述推杆组件施加推送力,并将所述栓塞弹簧圈10输送至体内。继续向所述推杆组件施加推送力,当所述栓塞弹簧圈10完全位于所述导管1外部时,若所述栓塞弹簧圈10已准确定位,施术者可在所述控制杆300的近端施加推送力,并使所述控制杆300沿由近端向远端方向移动至所述第二连接点和所述第一连接点之间的轴向距离等于所述预定值,以使得所述形变部的远端部分径向收缩至该部分的径向尺寸小 于或等于所述第一通孔213的孔径,此时所述推杆组件处于所述解锁位置。然后保持所述控制杆300和所述推杆100轴向相对静止,并在所述控制杆300和所述推杆100的近端施加回撤力,以使所述控制杆300和所述推杆100同步地沿由远端向近端的方向移动,直至所述控制杆300的远端端部携带所述形变部的远端部分穿过所述第一通孔213并位于所述第一挡部212的近端侧时,所述栓塞弹簧圈10携带所述第一子限位机构210脱离所述推杆100。在将所述推杆组件切换至所述解锁位置之前,若在推送所述栓塞弹簧圈10的过程中发现所述栓塞弹簧圈10的定位不准确,施术者可通过回撤所述推杆组件来将所述栓塞弹簧圈10重新回收至所述导管1的所述第二内腔,并在调整位置后重新释放。The operator then applies a pushing force to the push rod assembly at the proximal end of the push rod 100 and delivers the embolic coil 10 into the body. Continue to apply pushing force to the push rod assembly, when the embolic coil 10 is completely outside the catheter 1, if the embolic coil 10 has been correctly positioned, the operator can press the control rod 300 near the end to apply a pushing force, and make the control rod 300 move from the proximal end to the distal end until the axial distance between the second connection point and the first connection point is equal to the predetermined value, so that the The distal portion of the deformation portion is radially contracted until the radial dimension of this portion is smaller than or equal to the diameter of the first through hole 213 , and at this time the push rod assembly is in the unlocked position. Then keep the control rod 300 and the push rod 100 axially relatively stationary, and apply a retraction force on the proximal ends of the control rod 300 and the push rod 100, so that the control rod 300 and the push rod 100 The rod 100 moves synchronously along the direction from the distal end to the proximal end until the distal end portion of the control rod 300 carries the distal end portion of the deformable portion through the first through hole 213 and is positioned at the first through hole 213. At the proximal side of the blocking portion 212 , the embolic spring coil 10 carries the first sub-limiting mechanism 210 and disengages from the push rod 100 . Before switching the push rod assembly to the unlocked position, if the positioning of the embolic coil 10 is found to be inaccurate during the process of pushing the embolic coil 10, the operator can withdraw the push rod Assembly to recover the embolic coil 10 to the second lumen of the catheter 1 and release it after adjusting the position.
本实施例还提供了一种医用装置,包括医用植入物和所述推杆组件,所述推杆组件的所述第一子限位机构210连接于所述医用植入物的近端。This embodiment also provides a medical device, including a medical implant and the push rod assembly, and the first sub-limiting mechanism 210 of the push rod assembly is connected to the proximal end of the medical implant.
本发明实施例所提供的技术方案中,通过所述控制杆与所述限位机构的配合,使得所述推杆组件可在锁定位置和解锁位置之间切换,利用所述推杆组件推送并释放所述医用植入物时,只要所述推杆组件保持在所述锁定位置,便可随时回收所述医用植入物,以便于对所述医用植入物的位置进行调整,有利于提高所述医用植入物的定位精度,改善治疗效果。不仅如此,当所述推杆组件处于所述锁定位置时,还可避免在通过血管弯曲区域时发生第一子限位机构和所述第二子限位机构提前脱离的情况,提高可靠性。In the technical solution provided by the embodiment of the present invention, through the cooperation between the control rod and the limit mechanism, the push rod assembly can be switched between the locked position and the unlocked position, and the push rod assembly is used to push and When the medical implant is released, as long as the push rod assembly remains at the locking position, the medical implant can be recovered at any time, so as to adjust the position of the medical implant, which is beneficial to improve The positioning accuracy of the medical implant improves the therapeutic effect. Not only that, when the push rod assembly is at the locking position, it can also avoid the situation that the first sub-limiting mechanism and the second sub-limiting mechanism disengage early when passing through the bending area of the blood vessel, thereby improving reliability.
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。Although the present invention is disclosed above, it is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims (13)

  1. 一种推杆组件,其特征在于,包括:A push rod assembly is characterized in that it comprises:
    推杆,具有轴向贯通的第一内腔;The push rod has a first inner cavity axially penetrated;
    限位机构,包括第一子限位机构和第二子限位机构;所述第一子限位机构上形成有第一限位区,并还包括第一挡部,所述第一挡部设置于所述第一限位区的近端,且所述第一挡部上设有与所述第一限位区连通的第一通孔;所述第二子限位机构连接于所述推杆的远端;以及,The limiting mechanism includes a first sub-limiting mechanism and a second sub-limiting mechanism; the first sub-limiting mechanism is formed with a first limiting area, and also includes a first stop, the first stop It is arranged at the proximal end of the first limiting area, and the first stop part is provided with a first through hole communicating with the first limiting area; the second sub-limiting mechanism is connected to the the distal end of the push rod; and,
    控制杆;Controller;
    所述推杆组件被配置为当所述控制杆的远端穿过所述第一内腔及所述第一通孔,并与所述第二子限位机构的远端部分连接,且将所述第二子限位机构的远端部分限制于所述第一限位区内时,所述推杆组件处于锁定位置;当所述控制杆沿所述第一通孔的轴向移动,并允许所述第二子限位机构的远端部分脱离所述第一限位区时,所述推杆组件处于解锁位置。The push rod assembly is configured such that when the distal end of the control rod passes through the first inner cavity and the first through hole, and is connected with the distal end portion of the second sub-limiting mechanism, and will When the distal part of the second sub-limiting mechanism is limited in the first limiting area, the push rod assembly is in the locked position; when the control rod moves along the axial direction of the first through hole, And when the distal part of the second sub-limiting mechanism is allowed to break away from the first limiting area, the push rod assembly is in the unlocked position.
  2. 根据权利要求1所述的推杆组件,其特征在于,所述第一限位区形成于所述第一子限位机构的侧面上,并沿径向向内凹陷;所述第二子限位机构的侧面上形成有沿径向向内凹陷的第二限位区,并还包括第二挡部,所述第二挡部设置于所述第二限位区的远端并构成所述第二子限位机构的远端部分,所述第二挡部上设有第二通孔,且所述第二通孔、所述第二限位区及所述第一内腔依次连通;The push rod assembly according to claim 1, wherein the first limiting area is formed on the side of the first sub-limiting mechanism, and is radially inwardly recessed; the second sub-limiting area The side of the positioning mechanism is formed with a second limiting area radially inwardly recessed, and also includes a second blocking portion, which is arranged at the distal end of the second limiting area and constitutes the The distal part of the second sub-limiting mechanism, the second stopper is provided with a second through hole, and the second through hole, the second limiting area and the first inner cavity are sequentially connected;
    当所述推杆组件处于所述锁定位置时,所述控制杆还将所述第一挡部限制于所述第二限位区内,且所述控制杆的远端还穿过所述第二通孔;当所述控制杆沿由远端向近端的方向移动并使所述控制杆的远端位于所述第二限位区的近端侧时,所述推杆组件处于所述解锁位置,并还允许所述第一挡部脱离所述第二限位区。When the push rod assembly is in the locked position, the control rod also constrains the first stop part in the second limiting area, and the distal end of the control rod also passes through the first Two through holes; when the control rod moves in the direction from the distal end to the proximal end and the distal end of the control rod is located on the proximal side of the second limiting area, the push rod assembly is in the The unlocked position also allows the first blocking part to disengage from the second limiting area.
  3. 根据权利要求2所述的推杆组件,其特征在于,所述第二子限位机构还包括第一接合部,所述第一接合部位于所述第二限位区的近端,并与所述推杆的远端连接;所述第一接合部上设有第三通孔,所述第三通孔与所述第 一内腔及所述第二限位区连通,并用于供所述控制杆的远端贯穿。The push rod assembly according to claim 2, wherein the second sub-limiting mechanism further comprises a first engaging portion, the first engaging portion is located at the proximal end of the second limiting area, and is in contact with The distal end of the push rod is connected; the first joint part is provided with a third through hole, the third through hole communicates with the first inner cavity and the second limiting area, and is used for the The distal end of the control rod penetrates.
  4. 根据权利要求2所述的推杆组件,其特征在于,所述推杆组件用于可活动地穿设于一导管的第二内腔中,以将一医用植入物输送至目标位置。The push rod assembly according to claim 2, wherein the push rod assembly is used to movably pass through the second lumen of a catheter to deliver a medical implant to a target position.
  5. 根据权利要求4所述的推杆组件,其特征在于,所述第一挡部的宽度与所述第二挡部的宽度之和与所述第二内腔的直径的比值范围为1~1.5。The push rod assembly according to claim 4, characterized in that, the ratio of the sum of the width of the first blocking portion and the width of the second blocking portion to the diameter of the second inner cavity ranges from 1 to 1.5 .
  6. 根据权利要求1所述的推杆组件,其特征在于,所述第二子限位机构包括形变部,所述形变部环绕所述控制杆布置,且所述形变部的近端连接于所述推杆上的第一连接点处,所述形变部的远端连接于所述控制杆上的第二连接点处;所述形变部的远端部分即为所述第二子限位机构的远端部分;The push rod assembly according to claim 1, wherein the second sub-limiting mechanism includes a deformation portion, the deformation portion is arranged around the control rod, and the proximal end of the deformation portion is connected to the At the first connection point on the push rod, the distal end of the deformation part is connected to the second connection point on the control rod; the distal part of the deformation part is the part of the second sub-limiting mechanism. remote part;
    所述推杆组件被配置当所述形变部的远端部分穿过所述第一通孔并位于所述第一限位区,且当所述第二连接点到所述第一连接点的轴向距离小于预定值时,所述形变部的远端部分径向扩张至径向最大尺寸大于所述第一通孔的孔径,使得所述形变部的远端部分被限制在所述第一限位区内,当所述控制杆沿由近端向远端的方向移动,并使所述第二连接点到所述第一连接点的轴向距离等于所述预定值时,所述形变部的远端部分径向收缩至径向尺寸小于或等于所述第一通孔的孔径,以允许所述形变部的远端部分脱离所述第一限位区。The push rod assembly is configured when the distal portion of the deformation part passes through the first through hole and is located in the first limiting area, and when the second connection point is connected to the first connection point When the axial distance is less than a predetermined value, the distal end portion of the deformation portion is radially expanded to a radially largest dimension larger than the diameter of the first through hole, so that the distal end portion of the deformation portion is restricted within the first through hole. In the limit area, when the control rod moves in the direction from the proximal end to the distal end, and the axial distance from the second connection point to the first connection point is equal to the predetermined value, the deformation The distal portion of the deformation portion is radially shrunk to a radial dimension smaller than or equal to the diameter of the first through hole, so as to allow the distal portion of the deformation portion to break away from the first limiting area.
  7. 根据权利要求6所述的推杆组件,其特征在于,所述形变部包括多个弹片,多个所述弹片环绕所述控制杆依次布置;或者,所述形变部为弹性套,并套设在所述控制杆的外部。The push rod assembly according to claim 6, wherein the deformation part includes a plurality of elastic pieces, and the plurality of elastic pieces are sequentially arranged around the control rod; or, the deformation part is an elastic sleeve, and is sleeved on the outside of the control rod.
  8. 根据权利要求6所述的推杆组件,其特征在于,所述第一子限位机构具有第三内腔,所述第三内腔构成所述第一限位区。The push rod assembly according to claim 6, wherein the first sub-limiting mechanism has a third inner cavity, and the third inner cavity constitutes the first limiting area.
  9. 根据权利要求1所述的推杆组件,其特征在于,所述推杆由丝材编织成型。The push rod assembly according to claim 1, wherein the push rod is braided from wire.
  10. 根据权利要求1所述的推杆组件,其特征在于,所述控制杆的直径为所述第一通孔的孔径的50%~60%。The push rod assembly according to claim 1, wherein the diameter of the control rod is 50%-60% of the diameter of the first through hole.
  11. 根据权利要求1所述的推杆组件,其特征在于,第一子限位机构还包括第二接合部,设置于所述第一限位区的远端。The push rod assembly according to claim 1, wherein the first sub-limiting mechanism further includes a second engaging portion disposed at a distal end of the first limiting area.
  12. 一种医用装置,其特征在于,包括医用植入物和如权利要求1-11中任一项所述的推杆组件,所述第一子限位机构用于连接于所述医用植入物的近端。A medical device, characterized in that it comprises a medical implant and the push rod assembly according to any one of claims 1-11, the first sub-limiting mechanism is used to connect to the medical implant the proximal end.
  13. 根据权利要求12所述的医用装置,其特征在于,所述医用植入物包括栓塞弹簧圈。The medical device of claim 12, wherein the medical implant comprises an embolic coil.
PCT/CN2022/090375 2021-05-21 2022-04-29 Push rod assembly and medical device WO2022242450A1 (en)

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