CN116549045A - Engagement assemblies, core assemblies, systems, and methods for delivering implants - Google Patents
Engagement assemblies, core assemblies, systems, and methods for delivering implants Download PDFInfo
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- 210000003484 anatomy Anatomy 0.000 claims description 4
- 230000003902 lesion Effects 0.000 description 9
- 210000004204 blood vessel Anatomy 0.000 description 6
- 230000009467 reduction Effects 0.000 description 5
- 206010002329 Aneurysm Diseases 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- 230000009471 action Effects 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
- A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
An engagement assembly, core assembly, system and method for delivering an implant, the engagement assembly capable of clamping and releasing the implant, the engagement assembly comprising: a pin member including a pin head having a diameter that tapers from a distal end to a proximal end; and a proximal pusher including a chamber for receiving the pin head, a surface of the chamber in clearance fit with a surface of the pin head; the proximal end of the proximal end pusher is provided with an opening; wherein the proximal end of the pin element is fixedly connected to the distal end of a first elongate delivery member in the catheter via the aperture, and the proximal end of the proximal pusher is fixedly connected to the distal end of a second elongate delivery member in the catheter; the pin head is movable relative to the proximal pusher along the longitudinal axis of the catheter by relative movement between the first elongate delivery member and the second elongate delivery member. The core assembly and system include the engagement assembly. The present invention enables the implant to be retrieved and repositioned after release and effectively prevents slippage between the implant and the engagement assembly.
Description
Technical Field
The present invention relates to an engagement assembly, a core assembly, a system and a method for delivering an implant.
Background
Minimally invasive interventions are a treatment for vascular aneurysms and generally involve the delivery of vascular implants, such as, but not limited to, stents, coils, aneurysm occlusion devices, to a lesion site via a delivery system. The delivery system generally includes a catheter, a guidewire, and an implant engagement assembly, wherein the catheter is for insertion into a blood vessel to receive a vascular implant and to direct the vascular implant to a lesion in the blood vessel; the guidewire is generally fixedly attached to a portion of the implant engagement assembly; the implant engaging assembly is typically in contact with the implant for delivering the implant along the catheter to the lesion site under the influence of the guidewire.
However, the implant is not always deployed in the exact location that the physician or operator may want, and thus may need to be retracted into the catheter prior to full deployment. In conventional prior delivery systems, the implant is typically released immediately after being pushed out of the distal end of the catheter and cannot be retrieved back into the delivery tube for re-release. In this case, even if the release position of the implant is incorrect, no adjustment can be made. This can cause adverse complications to the procedure, increasing the risk of the procedure.
For this reason, it is desirable to design a delivery system that can be re-retrieved into the delivery catheter for re-release after the implant is released.
Currently, known patent CN112716667a discloses an endovascular implant fixation retention structure and an endovascular implant delivery system, comprising: the device comprises a conveying pipe, a guide wire penetrating through the conveying pipe and a holder connected to the guide wire. In the initial stage of conveying, the guide wire and the conveying pipe are kept relatively fixed, and the holder is positioned at the head of the conveying pipe and plays a role in fixing the implant; in the later stage of delivery, the guide wire and the delivery tube perform relative movement, the holder extends out of the head of the delivery tube, and the implant is released. When the length of the implant extending out of the distal end of the delivery tube does not exceed a certain value, the implant can be recovered through the guide wire to the position in the delivery tube for adjusting and re-releasing.
However, patent CN112716667a has the following problems:
on the one hand, the implant is driven to slide along the conveying pipe by the friction force between the implant and the holder, and the relative sliding of the implant and the holder and even the falling-off of the implant from the holder can possibly influence the conveying of the implant in the conveying pipe due to the change of the bending of the blood vessel morphology and the influence of the friction force of the two friction forces and the flatness of the inner wall of the guide pipe.
On the other hand, the relative position of the implant and the holder is uncertain when being assembled, and meanwhile, the relative sliding possibly occurs in the delivery process of the implant and the holder exacerbates the uncertainty of the relative position of the implant and the holder, so that the release position of the implant is inaccurate, the position of the implant needs to be adjusted for multiple times, and the problems of reduction of the release efficiency of the bracket, increase of the operation duration, increase of the operation risk and the like can be caused.
Disclosure of Invention
It is an object of the present invention to provide an engagement assembly for delivering an implant that allows for retrieval of the implant after release, allowing repositioning of the implant as desired, while ensuring delivery of the implant to the lesion.
It is another object of the present invention to provide a core assembly for delivering an implant.
It is another object of the present invention to provide a system for delivering an implant.
It is yet another object of the present invention to provide a method for delivering an implant.
According to a first aspect of the present invention, an engagement assembly for delivering an implant is disclosed, adapted to clamp and release the implant when the implant is delivered via a catheter. The engagement assembly includes: a pin member including a pin head having a diameter that tapers from a distal end to a proximal end; a proximal pusher comprising a cavity adapted to receive the pin head, a surface of the cavity in clearance fit with a surface of the pin head; the proximal end of the proximal end pusher is provided with an opening; wherein the proximal end of the pin element is fixedly connected to the distal end of a first elongate delivery member in the catheter via the aperture, and the proximal end of the proximal pusher is fixedly connected to the distal end of a second elongate delivery member in the catheter; wherein the pin head is movable relative to the proximal pusher in the direction of the longitudinal axis of the catheter by relative movement between the first and second elongate delivery members to move the pin head into or out of the lumen of the proximal pusher.
Preferably, the engagement assembly includes a clamped condition in which the pin head is located within the chamber of the proximal pusher and a gap between a surface of the pin head and a surface of the chamber is no greater than a thickness of the implant to enable a proximal end of the implant to be clamped between the pin head and the chamber of the proximal pusher.
Preferably, the engagement assembly includes a released state in which a gap between a surface of the pin head and a surface of the cavity is greater than a thickness of the implant to enable the implant to be released from the engagement assembly.
Further, the pin head decreases in diameter linearly from the distal end to the proximal end; or the diameter of the pin head is reduced from the distal end to the proximal end in a nonlinear manner; or the pin head diameter decreases piecewise linearly from the distal end to the proximal end.
Preferably, the pin head is a conical or frustoconical pin head.
Preferably, the conical surface of the conical or frustoconical pin head is angled no more than 30 degrees, more preferably no more than 20 degrees, from the central axis.
Preferably, in said clamped state, the length of the proximal end of said implant clamped between the pin head and the chamber of the proximal pusher is comprised between 5% and 30% of the total length of the implant.
Preferably, the first elongate delivery member is a guidewire and the second elongate delivery member is a tubular member that is over the guidewire.
Preferably, the tubular member is a hypotube.
Preferably, the proximal end of the pin element is fixedly connected to the first elongate delivery member by welding, bonding, hinging and/or clamping, and the proximal end of the proximal pusher is fixedly connected to the second elongate delivery member by welding, bonding, hinging and/or clamping.
Preferably, the pin element further comprises a pin shank connected to the pin head, the pin head being fixedly connected to the first elongate delivery member via the pin shank; the aperture is in clearance fit with the pin shank. Preferably, the pin head and the pin shank are integrally formed.
Preferably, the proximal pusher has a cylindrical outer surface; the distal-most end of the pin head has a diameter less than the diameter of the cylindrical outer surface of the proximal pusher.
Preferably, the diameter of the aperture is smaller than the diameter of the proximal most end of the pin head.
According to a second aspect of the present invention, a core assembly for delivering an implant is provided. The core assembly comprising an engagement assembly for delivering an implant according to the first aspect of the invention, further comprising: a first elongate delivery member and a second elongate delivery member positioned in the catheter.
According to a third aspect of the present invention, a system for delivering an implant is disclosed. The system comprises a core assembly for delivering an implant according to the second aspect of the invention, further comprising a catheter and an implant.
According to a fourth aspect of the present invention, a method for delivering an implant is disclosed. The method uses an engagement assembly for delivering an implant according to the first aspect of the invention, the method comprising: pushing the first and second elongate delivery members while retracting the first elongate delivery member relative to the second elongate delivery member to deliver the engagement assembly and implant to a designated location of the hollow anatomical structure within the catheter with the proximal end of the implant sandwiched between the pin head and the chamber of the proximal pusher; after the implant reaches the prescribed position, pulling the catheter proximally, causing the engagement assembly and implant to extend out of the catheter; pushing the first elongate delivery member to move the pin head away from the pusher chamber and determining whether adjustment of the implant position is required: if the position of the implant needs to be adjusted, the first elongated delivery member is pulled back to re-enter the pin head into the chamber of the proximal pusher to allow the engagement assembly to re-grip the implant; if no adjustment of the position of the implant is necessary, the first and second elongate delivery members are retracted to release the implant and withdraw the engagement assembly.
Compared with the prior art, the invention has the following advantages:
1. the implant can also be retrieved after release, allowing repositioning of the implant as desired, while ensuring delivery of the implant to the lesion site.
2. The pin head with the diameter gradually reduced from the far end to the near end and the cavity of the near-end pusher can ensure large pushing force and clamping force, and prevent the implant from accidentally breaking loose and falling off. This is because, on the one hand, during the delivery of the implant, the chamber surface of the proximal pusher will actually act against the engagement portion of the implant, thus generating a forward thrust on the engagement portion of the implant, which is more robust and reliable than the thrust generated by friction alone; on the other hand, the pin head with the diameter gradually decreasing from the distal end to the proximal end can increase the contact area with the implant under the condition of the same length relative to the cylindrical pin head, and the clamping force is increased along with the increase of the pull-back force of the pin head, so that the clamping force of the implant can be effectively ensured and regulated.
3. Due to the abutting action of the joint component on the implant and the large clamping force, the implant can be effectively prevented from sliding with a delivery device (such as a bracket joint component and the like) in the delivery process, so that the cut-off point of the implant is fixed, the implant can be more accurately delivered to a lesion position in the process of observing the positioning of the implant by means of development and combining the delivery operation to place the implant, the adjustment times of the implant position are reduced, and the operation time is saved.
Drawings
The accompanying drawings illustrate embodiments of the invention by way of example and not limitation, in which:
FIG. 1 shows a schematic diagram of a transport system according to one embodiment of the invention;
FIG. 2 illustrates a schematic view of disengaging the distal end of the pin member from the proximal pusher in preparation for releasing the stent in the delivery system according to one embodiment of the present invention;
fig. 3 shows a schematic view of a stent being fully released in a delivery system according to one embodiment of the invention.
Detailed Description
The technical scheme of the present invention will be described in further detail below by way of examples with reference to the accompanying drawings, but the present invention is not limited to the following examples.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the embodiments described herein, the preferred methods, devices, and materials are described herein.
The terms "distal", "distal" or "proximal", "proximal" refer in the following description to a position or orientation relative to the operator. "distal" or "distal" refers to a location or direction away from the operator.
The terms "connected," "connected," or "fixedly connected" refer to a connection between two elements, and are not only intended to encompass the direct connection or contact between the two elements, but also to the connection between the two elements through one or more intermediate elements, as well as to the integral formation of the two elements. Furthermore, the term "fixedly attached" refers to a connection having little relative movement after two elements are secured, including releasable and non-releasable connections.
Fig. 1 shows a schematic configuration of a conveying system 10 according to an embodiment of the present invention.
According to this embodiment, the delivery system of the present invention may be used to deliver and/or deploy an implant (e.g., a stent) into a hollow anatomical structure such as a blood vessel. As shown in fig. 1, the delivery system of the present invention includes a stent 11, a core assembly, and a catheter 13.
The stent 11 may comprise a braided stent or other form of stent, such as a laser cut stent, a roll stent, or the like. In embodiments related to braided stents, the stent 11 may be braided from round or oval wire filaments. Further, the stent 11 is self-expanding and one or more filaments may be formed from a biocompatible metallic material or a biocompatible polymer.
The conduit 13 is located outside of a core assembly that is relatively slidable within the conduit, and the core assembly may be configured to carry a stent through the conduit. Once the distal end of the catheter 13 is at the desired location, the stent 11 may be pushed out of the catheter 13 by withdrawing the catheter 13, or the stent 11 may be pushed out of the catheter 13 by pushing the core assembly. The catheter 13 is of elongate construction comprising a proximal end, a distal end and a central lumen, the distal end of the catheter 13 being provided with an opening to facilitate the core assembly carrying the stent 11 to extend the catheter 13 from the opening to release the stent 11. The catheter 13 may be a microcatheter or a sheath.
The core assembly is located within the central cavity of said conduit 13 and is axially movable as a whole with respect to the conduit 13. The core assembly may be advanced within the lumen of the catheter 13 (or the catheter 13 may be retracted) to expose the stent 11 and allow it to expand within the patient's blood vessel. The core assembly includes an engagement assembly, a second elongate delivery member 15, a first elongate delivery member, and the like. The engagement assembly is located at the distal ends of the first and second elongate delivery members, and the proximal end of the stent 11 engages the engagement assembly to allow the user to push the crimped stent 11 forward out of the catheter 13.
The engagement assembly further comprises a pin element 41 and a proximal pusher 42.
The pin element 41 may comprise a pin head 43 and a pin shank 44 connected, wherein the pin head 43 and the pin shank 44 are located at the distal and proximal ends of the pin element 41, respectively. The pin shank 44 is in a rod shape, a bar shape or a flat strip shape, the pin head 43 is in a structure that the diameter gradually decreases from the distal end to the proximal end, and the gradual decrease of the diameter of the pin head 43 from the distal end to the proximal end can be linear decrease or nonlinear decrease. When this decrease is a linear decrease, the pin head 43 is configured in a tapered or frustoconical configuration. When the reduction is a non-linear reduction, the pin head 43 may be configured in a generally conical configuration or other suitable configuration, such as a top, horn, bell, or the like. Furthermore, the reduction may also be a piecewise linear reduction. For example, the pin head 43 may include a distal segment and a proximal segment, wherein the distal segment and the proximal segment are frustoconical structures having different apex angles.
In particular, when the pin head 43 is a tapered or frustoconical pin head, the conical surface of the tapered or frustoconical pin head is at an angle of no more than 30 degrees, preferably no more than 20 degrees, from the central axis. Such an angle may allow the bracket 11 to be more firmly and stably clamped between the pin head 43 and the proximal pusher 42, and may not easily deform the bracket 11.
In a preferred embodiment, the pin head 43 and pin shank 44 are integrally formed. In some embodiments, the pin head 43 and the pin shank 44 may be formed separately and fixedly attached by welding, bonding, hinging, and/or clamping.
In the preferred embodiment, the outer surface of the proximal pusher 42 is cylindrical and includes an open cavity, which cavity of the proximal pusher 42 is adapted to receive the pin head 43 of the pin member 41. Which is in a clearance fit with the pin head 43 of the pin element 41. In other words, the chamber diameter of the proximal pusher 42 also tapers proximally from the distal end. The proximal end of the proximal pusher 42 is vented to mate with a pin shank 44 of the pin element 41. The term "mated" as used herein means that the pin shank 44 is approximately the same size as the aperture so that the pin shank 44 can pass through the aperture. Meanwhile, the shape of the cross section of the pin shank 44 may or may not be identical to the shape of the opening, as long as it is ensured that the pin shank 44 can pass through the opening. The aperture is preferably located at a proximal central location of the proximal pusher 42.
The engagement assembly includes a gripping state and a release state. In the clamped state the pin head 43 of the engagement assembly is located in the cavity of the proximal pusher 42 with a certain gap 45 between the surface of the pin head 43 of the pin element 41 and the surface of the cavity of the proximal pusher 42, said gap 45 being adapted to receive the proximal end of the stent 11, the thickness of the gap 45 being no greater than the thickness of said stent, which ensures that the stent is firmly gripped, i.e. that the proximal end of the stent 11 can be clamped between the pin head 43 and the cavity of the proximal pusher 42. In the released state, the gap between the surface of the pin head 43 and the surface of the chamber is greater than the thickness of the bracket 11 to enable the bracket 11 to be released from the engagement assembly. In the released state, the pin head 43 may be located entirely outside the chamber of the proximal pusher 42 or may not completely leave the chamber of the proximal pusher 42.
Furthermore, in the clamped state, the length of the proximal end of the stent 11 clamped between the pin head 43 and the chamber of the proximal pusher 42 preferably accounts for 5% -30% of the total length of the stent. Such a clamping ratio ensures that the stent 11 is clamped more stably and firmly, prevents the stent 11 from falling off or slipping relative to the engagement assembly during delivery, thereby affecting the accuracy of the stent release position, and is less likely to cause stent deformation.
The distal end of the first elongate delivery member is fixedly connected to the proximal end of the pin shank 44 of the pin element 41 via the aperture of the proximal pusher, and the distal end of the second elongate delivery member 15 is fixedly connected to the proximal end of the proximal pusher 42. The fixed connection between the first elongate delivery member and the pin shank 44 of the pin element 41 and the fixed connection between the second elongate delivery member 15 and the proximal pusher 42 may be by welding, adhesive, hinging, and/or snap-fit, etc.
It should be noted that although in the previous description it was mentioned that the pin element 41 comprises a pin shank 44 and that the pin head 43 is connected to the first elongated delivery member by means of the pin shank 44, in practice the pin element 41 does not necessarily comprise a pin shank 44. For example, in some embodiments, the distal end of the first elongate delivery member may also be fixedly attached directly to the pin head 43 via an opening in the proximal end of the proximal pusher 42, where the opening in the proximal end of the proximal pusher 42 mates with the distal end of the first elongate delivery member. In this case, the distal end of the first elongate delivery member is directly push-pull controlled by the pin head 43. Of course, the presence of the pin shank 44 is also advantageous, for example, in that the pin element 41 and the elongated delivery member can be easily and fixedly connected by the pin shank 44, which is more efficient and quick to assemble.
In this embodiment, the first elongate delivery member is a guidewire and the second elongate delivery member 15 is a delivery tube. The delivery tube is sleeved on the guide wire, so that the guide wire can be supported and protected to a certain extent. It is noted that in other embodiments, the first and second delivery members may also comprise a guidewire, a delivery tube, a coil, or any combination thereof. The guide wire may be a metal filament made of a metal material, and its specific shape and structure are not described herein. The delivery tube may be a hypotube or other suitable tubular structure.
Further, the distal-most end of pin head 43 preferably has a diameter less than the diameter of the cylindrical outer surface of proximal pusher 42. In this way, when the pin head 43 fully enters the cavity of the proximal pusher 42, the distal-most end of the pin head 43 does not extend radially beyond the proximal pusher 42. Preferably, the diameter of the aperture is smaller than the diameter of the proximal most end of the pin head 43 and the diameter of the aperture is greater than or equal to the diameter of the pin shank 44 so that the pin head 43 can become lodged in the cavity of the proximal pusher 42 when the pin shank 44 is pulled back by the guidewire.
According to the design described above, clamping, delivery, release, re-clamping and re-release of the stent 11 can be achieved by controlling the axial movement of the delivery tube and guidewire along the catheter 13, respectively, to control the axial movement of the pin element 41 and proximal pusher 42 along the catheter 13, respectively.
For example, when the guidewire is advanced relative to the delivery tube, the pin element 41 is moved forward relative to the proximal pusher 42 to unseat the pin head 43 of the pin element 41 from the lumen of the proximal pusher 42 to facilitate release of the proximal end of the stent 11. For another example, when the guidewire is pulled back relative to the delivery tube, the pin element 41 moves back relative to the proximal pusher 42, and the pin head 43 of the pin element 41 enters the chamber of the proximal pusher 42 to facilitate engagement or re-engagement of the proximal end of the stent 11. For another example, when the pin head 43 of the pin element 41 is fully advanced into the lumen of the proximal pusher 42 and simultaneously pushes the delivery tube and guidewire distally along the catheter 13, the engagement assembly remains engaged with the proximal end of the stent 11 and simultaneously pushes the stent 11 distally.
Meanwhile, according to the above design, since the stent 11 is actually wrapped and gripped in the cavity of the proximal pusher 42 and the cavity is adapted to the shape of the pin head 43, the diameter of which is gradually reduced from the distal end to the proximal end, the cavity surface of the proximal pusher 42 is actually abutted against the engaging portion of the stent 11 during the delivery of the stent 11, thereby generating a forward pushing force on the engaging portion of the stent 11. This abutment thrust is quite different from the thrust produced by friction alone in the prior art. Compared with the pushing force generated by friction, the pushing force generated by the abutting action is more stable and reliable, and the sliding of the stent 11 and a delivery device (such as a stent joint assembly and the like) in the delivery process can be effectively prevented, so that the stent 11 can be delivered to a lesion position more accurately, the number of times of stent position adjustment is reduced, and the operation time is further saved.
This embodiment discusses the case when the implant is a stent and the delivery system with respect to the stent, however other annular implants are contemplated for delivery by the delivery system, such as microcoils, occluders or the like. The stent may include a proximal end and a distal end. The implant may be configured to interfere with blood flow for the purpose of treating aneurysms, such as aneurysms in blood vessels including arteries in the brain or elsewhere in the body, such as peripheral arteries.
A method for delivering an implant is described below in accordance with one embodiment of the present invention.
FIG. 2 shows a schematic view of the distal end of the pin element 41 disengaged from the proximal pusher; fig. 3 shows a schematic view of the stent being fully released.
As shown in fig. 2 and 3, the method generally comprises the steps of:
(1) The engagement assembly and stent 11 are loaded into the catheter 13 and delivered via the catheter 13 to the vicinity of a designated location (i.e., lesion) of the hollow anatomical structure.
In this step, the engagement assembly is held in a clamped state by manipulating the delivery tube and guidewire while the stent 11 is delivered within the catheter 13, with the proximal end of the stent 11 clamped between the pin head and the chamber of the proximal pusher. The particular manner of operation is to simultaneously push the delivery tube and guidewire and simultaneously pull the guidewire back relative to the delivery tube to remain relatively stationary during delivery, thereby allowing the engagement assembly to push the stent 11 distally to a designated position while simultaneously clamping the stent 11.
(2) When the stent 11 is delivered to the lesion, the engagement assembly is brought into a released state by manipulating the delivery tube and guidewire in preparation for releasing the stent, including pulling the catheter 13 proximally first, extending the engagement assembly out of the catheter 13, thereby exposing a majority of the stent (i.e., the portion of the stent 11 other than the proximal end); the guide wire is then pushed distally to push the pin shank 44 of the pin member 41 distally through the guide wire, causing the pin head 43 of the pin member 41 to gradually move away from the cavity of the proximal pusher 42, such that the gap between the surface of the pin head 43 and the surface of the cavity of the proximal pusher 42 is greater than the thickness of the stent 11, such that the proximal end of the stent 11 loses clamping force and can be released.
(3) After pin head 43 exits the chamber of proximal pusher 42, it may be further determined whether the position of bracket 11 needs to be adjusted. If it is desired to adjust the position of the stent 11 or if it is otherwise desired to retract the stent, the guidewire may be retracted to pull the pin shank 44 of the pin element 41 in a proximal direction and again pull the pin head 43 of the pin element 41 into the cavity of the proximal pusher 42, which may place the engagement assembly in a clamped condition, reclamping the stent 11 to perform the recapture and repositioning (Re-capture and Re-positioning). If the stent 11 can be released without the need to readjust the position of the stent 11, the guidewire and delivery tube are simultaneously retracted to simultaneously pull the pin element 41 and proximal pusher 42 in a proximal direction, the engagement assembly will remain released, while the friction of the stent 11 with tissue at the designated location (e.g., vessel wall) holds the position of the stent 11 unchanged, and retraction of the proximal pusher 42 disengages the proximal end of the stent 11 from the lumen of the proximal pusher 42, allowing the stent 11 to be fully released.
The foregoing description, for purposes of explanation, has been presented with reference to particular embodiments of the invention. However, the illustrative description above is not intended to be exhaustive or to limit the invention to the precise form disclosed.
Claims (16)
1. An engagement assembly for delivering an implant adapted to clamp and release the implant when delivered via a catheter, the engagement assembly comprising:
a pin member including a pin head having a diameter that tapers from a distal end to a proximal end;
a proximal pusher comprising a cavity adapted to receive the pin head, a surface of the cavity in clearance fit with a surface of the pin head; an opening is formed in the proximal end of the proximal end pusher;
wherein the proximal end of the pin element is fixedly connected to the distal end of a first elongate delivery member in the catheter via the aperture, and the proximal end of the proximal pusher is fixedly connected to the distal end of a second elongate delivery member in the catheter;
wherein the pin head is movable relative to the proximal pusher in the direction of the longitudinal axis of the catheter by relative movement between the first and second elongate delivery members to move the pin head into or out of the lumen of the proximal pusher.
2. The engagement assembly for delivering an implant of claim 1, comprising a clamped state in which the pin head is located within a chamber of a proximal pusher and a gap between a surface of the pin head and a surface of the chamber is no greater than a thickness of the implant such that a proximal end of the implant can be clamped between the pin head and the chamber of the proximal pusher.
3. The engagement assembly for delivering an implant of claim 1 or 2, comprising a released state in which a gap between a surface of the pin head and a surface of the cavity is greater than a thickness of the implant to enable release of the implant from the engagement assembly.
4. The engagement assembly for delivering an implant of claim 2, wherein in the clamped state, the length of the proximal end of the implant clamped between the pin head and the chamber of the proximal pusher is 5% -30% of the total length of the implant.
5. The engagement assembly for delivering an implant of claim 1, wherein the pin head decreases in diameter linearly from distal to proximal; or the diameter of the pin head is reduced from the distal end to the proximal end in a nonlinear manner; or the pin head diameter decreases piecewise linearly from the distal end to the proximal end.
6. The engagement assembly for delivering an implant of claim 1, wherein the pin head is a tapered or frustoconical pin head.
7. The engagement assembly for delivering an implant of claim 6, wherein the conical surface of the tapered or frustoconical pin head is angled no more than 30 degrees from the central axis.
8. The engagement assembly for delivering an implant of claim 1, wherein the first elongate delivery member is a guidewire and the second elongate delivery member is a tubular member that fits over the guidewire.
9. The joint assembly for delivering an implant of claim 8, wherein the tubular member is a hypotube.
10. The engagement assembly for delivering an implant of claim 1, wherein a proximal end of the pin element is fixedly connected to the first elongate delivery member by welding, bonding, hinging, and/or clamping, and a proximal end of the proximal pusher is fixedly connected to the second elongate delivery member by welding, bonding, hinging, and/or clamping.
11. The engagement assembly for delivering an implant of claim 1, wherein the pin element further comprises a pin shank connected to the pin head, the pin head being fixedly connected to the first elongate delivery member via the pin shank; the aperture is in clearance fit with the pin shank.
12. The engagement assembly for delivering an implant of claim 1, wherein the proximal pusher has a cylindrical outer surface; the distal-most end of the pin head has a diameter less than the diameter of the cylindrical outer surface of the proximal pusher.
13. The engagement assembly for delivering an implant of claim 1, wherein the diameter of the aperture is less than the diameter of the proximal-most end of the pin head.
14. A core assembly for delivering an implant, comprising the engagement assembly for delivering an implant according to any one of claims 1-13, further comprising: the first elongate delivery member and the second elongate delivery member.
15. A system for delivering an implant, comprising the core assembly for delivering an implant according to claim 14, further comprising the catheter and the implant.
16. A method for delivering an implant, characterized in that an engagement assembly for delivering an implant according to any one of claims 1-13 is used, the method comprising:
pushing the first and second elongate delivery members while retracting the first elongate delivery member relative to the second elongate delivery member to deliver the engagement assembly and implant to a designated location of the hollow anatomical structure within the catheter with the proximal end of the implant sandwiched between the pin head and the chamber of the proximal pusher;
after the implant reaches the prescribed position, pulling the catheter proximally, causing the engagement assembly and implant to extend out of the catheter;
pushing the first elongate delivery member to move the pin head away from the pusher chamber and determining whether adjustment of the implant position is required:
if the position of the implant needs to be adjusted, the first elongated delivery member is pulled back to re-enter the pin head into the chamber of the proximal pusher to allow the engagement assembly to re-grip the implant;
if no adjustment of the position of the implant is necessary, the first and second elongate delivery members are retracted to release the implant and withdraw the engagement assembly.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210113811.7A CN116549045A (en) | 2022-01-30 | 2022-01-30 | Engagement assemblies, core assemblies, systems, and methods for delivering implants |
| PCT/CN2023/073841 WO2023143607A1 (en) | 2022-01-30 | 2023-01-30 | Engagement assembly, core assembly, system, and method for delivering implant |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210113811.7A CN116549045A (en) | 2022-01-30 | 2022-01-30 | Engagement assemblies, core assemblies, systems, and methods for delivering implants |
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| Publication Number | Publication Date |
|---|---|
| CN116549045A true CN116549045A (en) | 2023-08-08 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210113811.7A Pending CN116549045A (en) | 2022-01-30 | 2022-01-30 | Engagement assemblies, core assemblies, systems, and methods for delivering implants |
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| CN (1) | CN116549045A (en) |
| WO (1) | WO2023143607A1 (en) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2788964A1 (en) * | 2010-02-08 | 2011-08-11 | Surpass Medical Ltd. | Method and device for treating cerebrovascular pathologies and delivery system therefor |
| GB201017834D0 (en) * | 2010-10-21 | 2010-12-01 | Angiomed Ag | System to deliver a bodily implant |
| US9956103B2 (en) * | 2013-03-11 | 2018-05-01 | DePuy Synthes Products, Inc. | Stent delivery system and method |
| CA2922681C (en) * | 2013-08-27 | 2018-05-01 | Covidien Lp | Luminal stenting |
| CN112716667A (en) * | 2021-01-22 | 2021-04-30 | 江苏暖阳医疗器械有限公司 | Implant fixing and holding structure in blood vessel and implant conveying system in blood vessel |
| CN217548130U (en) * | 2022-01-30 | 2022-10-11 | 苏州徕瑞医疗技术有限公司 | Engagement assemblies, core assemblies, and systems for delivering implants |
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2022
- 2022-01-30 CN CN202210113811.7A patent/CN116549045A/en active Pending
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- 2023-01-30 WO PCT/CN2023/073841 patent/WO2023143607A1/en unknown
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| WO2023143607A1 (en) | 2023-08-03 |
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