WO2023223332A1 - Implant detachment mechanism - Google Patents
Implant detachment mechanism Download PDFInfo
- Publication number
- WO2023223332A1 WO2023223332A1 PCT/IN2022/050550 IN2022050550W WO2023223332A1 WO 2023223332 A1 WO2023223332 A1 WO 2023223332A1 IN 2022050550 W IN2022050550 W IN 2022050550W WO 2023223332 A1 WO2023223332 A1 WO 2023223332A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- implant
- block
- detaching mechanism
- pin
- pusher block
- Prior art date
Links
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Classifications
-
- 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
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- 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
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- 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
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
Definitions
- the present invention relates to a percutaneous implant delivery system and methods to deliver an implant inside a human or animal body. Specifically, the invention is related to an implant detachment mechanism for assisting in deployment of a coronary or a peripheral implant.
- an alternative less invasive transcatheter approach that delivers an implant using a percutaneous catheter transvascularly through variety of access points in a cardiovascular network e.g., through femoral artery, transapically, transaortic, trans-axillary etc.
- These implants may be, but not limited to, a stent, a valve, a mesh, a balloon, a patch, a drug-containing matrix, a shunt, or a combination thereof.
- a catheter delivery system carrying an implant, plays a vital role as the operator’s maneuvering actions at proximal end (handle) of a delivery system directly impacts the positioning, movement of the distal section (tip and capsule), and performance of the implant after the deployment.
- the effect of maneuvering actions transfers through a catheter shaft from the proximal end to the distal end.
- the catheter shaft is situated between the proximal end and the distal end.
- the implant doesn’t get detached from the delivery i system quickly and requires additional maneuvering that consumes additional time and may also reduce accuracy in positioning of the implant.
- an implant detaching mechanism to detach an implant from an implant holder comprises a catheter having a guidewire shaft, an inner shaft, a handle and a rotary knob.
- a release block and a pusher block combinedly forms the implant holder.
- the release block has a detaching end that has an impact surface
- the pusher block has at least a pin
- the pusher block is fixed on the inner shaft
- the release block is fixed on the guidewire shaft.
- the relative movement between the inner shaft and the guidewire shaft causes the release block and the pusher block to move closer and apart.
- the pin is used for engaging the implant.
- the impact surface at the detaching end of the release block impacts the pin and the resultant impact force contributes in detachment of the engaged implant from the pin.
- an implant detaching mechanism to detach an implant from an implant holder comprises a catheter having a guidewire shaft, an inner shaft, a rotary knob and a handle.
- a release block containing at least one leg and a pusher block containing at least one sliding slot combinedly forms the implant holder, wherein the leg and the sliding slot are arranged in a sliding manner.
- the release block comprises a releasing part that along its length has a symmetric or asymmetric shape. On moving the release block towards the pin and due to symmetric or asymmetric shape of the releasing part, a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin as the release block approaches the pin.
- the pusher block is movable due to longitudinally movable inner shaft and on moving the pusher block, the pin moves towards the release block and due to linear or non-linear shape of the releasing part, a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin as the release block approaches the pin.
- an implant detaching mechanism to detach an implant from an implant holder comprises a catheter having a guidewire shaft, an inner shaft, a rotary knob and a handle.
- a riser, a receiver and a movable pin combinedly forms the implant holder.
- the riser and the receiver have at least one inclined end.
- the riser and the receiver are fixed on the guidewire shaft and their inclined ends face each other.
- the movable pin is made of cylindrical part and a hook, wherein the cylindrical part is slidingly movable in a slot in the inner shaft.
- the hook has two inclined surface, and the hook is situated, without any fixed connection, between the riser and the receiver, each inclined surface of the hook accommodates with the inclined surfaces of the riser and the receiver.
- each inclined surface of the hook accommodates with the inclined surfaces of the riser and the receiver.
- the cylindrical part of the movable pin moves through the slot in the inner shaft in vertical direction and the inclined surfaces of the hook slides on the inclined surfaces of the riser and the receiver.
- FIG. 1 illustrates a side view of a typical catheter delivery system, according to an embodiment of the present invention
- FIG. 1 A illustrates an isotropic view of a handle of the catheter delivery system
- FIG. IB shows a cross-sectional view of the handle of the catheter delivery system, according to an embodiment of the present invention
- FIG. 1C shows a cross-sectional view of the handle of the catheter delivery system, according to an embodiment of the present invention
- FIG. 2 and 2A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to an embodiment of the present invention
- FIG. 2B illustrates a magnified, side view and a cross-sectional view along A-A plane of a pusher block of an implant holder of a catheter delivery system, depicting pushing surfaces and seating notch, according to an embodiment of the present invention
- FIG. 2C illustrates a magnified and isotropic view of a release block of an implant holder of a catheter delivery system, depicting detaching end and legs attached to the release block, according to an embodiment of the present invention
- FIG. 3 and 3A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to another embodiment of the present invention
- FIG. 4 and 4A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to yet another embodiment of the present invention
- FIG. 5 and 5A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to yet another embodiment of the present invention
- FIG. 6 and 6A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to yet another embodiment of the present invention
- FIG. 7 and 7A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block around a pin wherein one arrangement causes detachment of the implant from the implant holder, according to yet another embodiment of the present invention
- FIG. 8 and 8A illustrate a magnified and side view of an implant holder of a catheter delivery system, depicting two arrangements of a pusher block and a release block in the implant holder wherein one arrangement causes detachment of the implant from the implant holder, according to yet another embodiment of the present invention
- FIG. 9, 9B and 9D illustrate a side view, a cross-sectional side view and a three- dimensional side view respectively, of an implant holder of a catheter delivery system depicting a mechanism of using a movable pin where the pin is in disappearing position, according to yet another embodiment of the present invention
- FIG. 9A, 9C and 9E illustrate a side view, a cross-sectional side view and a three- dimensional side view respectively, of an implant holder of a catheter delivery system depicting a mechanism of using a movable pin where the pin is in visible position, according to yet another embodiment of the present invention.
- FIG. 9F illustrate a cross-sectional side view of a movable pin of an implant holder of a catheter delivery system, according to yet another embodiment of the present invention.
- a catheter delivery system for trans-vascularly delivering and deploying an implant in a human or animal organ, comprises a detachment mechanism to ensure disconnect of the implant from the catheter delivery system once the implant reaches its deployment location and it is in correct position too.
- the detachment of the implant from the catheter delivery system is an incident after which the implant cannot be maneuvered anymore and the next process steps of retraction of the catheter from the deployment site initiate.
- a typical catheter delivery system comprises a distal section, a middle section, and a proximal section.
- the proximal section remains outside the human body and comprises a handle housing that encompasses mechanisms to control the movements at the distal section of the catheter.
- the distal section comprises a tip, an inner shaft, a guidewire shaft, an implant holder and a capsule wherein, in a loaded state, the distal section comprises an implant too.
- the middle section is connected proximally with the handle housing and distally it connects to the distal section.
- the capsule is a hollow, cylindrical part that is movable through movement mechanisms present in the middle section and actuated from the proximal section.
- the capsule provides an inside space where the implant is loaded in compressed form and the capsule helps in retaining the implant in compressed form.
- capsule-based catheter delivery systems are used for delivery of implants whose frame structure is made of shape memory alloys e.g., Nitinol. Such implants don’t require any external force to regain their un-compressed structure. Due to shape -memory property, such implants start attaining their normal structure from an end once the capsule is moved to uncover the implant, starting from the end.
- the implant is situated over the guidewire shaft and in between the tip and the implant holder.
- the inner shaft extends longitudinally along the middle section from a proximal end of the distal section and further extends till a proximal end of the proximal section.
- the guidewire shaft extends from the proximal end of the proximal section till a distal end of the distal section.
- the guidewire shaft is connected to a threaded shaft and that connects to a rotary knob.
- the inner shaft is fixed to the handle housing and not movable. However, by rotating the rotary knob, the threaded shaft moves in longitudinal direction which in turn moves the guidewire shaft.
- the inner shaft is connected to the threaded shaft and that connects to the rotary knob.
- the guidewire shaft is fixed to the handle housing and not movable. However, by rotating the rotary knob, the threaded shaft moves in longitudinal direction which in turn moves the inner shaft.
- the engaging part of the frame of the implant gets engaged with the pin of the implant holder.
- the capsule is moved to compress and house the implant inside the hollow cylindrical part of the capsule.
- the capsule is moved to uncover the implant and the engaged part of the frame of the implant moves back to its original shape. In normal operation, this is sufficient to disengage the implant from the frame holder. However, in some cases, additional maneuvering is required to ensure detachment of the implant frame.
- the implant holder is a two-part hub-like cylindrical part and situated inside the capsule at a proximal end of the distal section.
- a pusher block of the implant holder is attached to the inner shaft whereas a second part, a release block, is attached to the guidewire shaft.
- Distal side of the pusher block has a plurality of pins on its peripheral surface. These pins are, optionally, at equal distance and angle from each other circumferentially.
- Distal side of the release block of the implant holder is fixed to the guidewire shaft.
- Proximal side of the pusher block of the implant holder is fixed to the inner shaft.
- Proximal side of the release block has a plurality of legs where any two legs have a space between them to accommodate at least one pin located on the distal side of the pusher block.
- the pusher block has at least one sliding slot to accommodate at least one leg of the release block in sliding manner.
- the leg In assembled state, the leg is accommodated inside the sliding slot and on moving the guide wire shaft, the release block moves in longitudinal direction and the leg travels in the sliding slot.
- the inner shaft is movable in longitudinal direction and the guidewire shaft is fixed. In this arrangement, on moving the inner shaft, the pusher block moves in longitudinal direction and the release block is fixed.
- the accommodation of the leg in the sliding slot remains same and the sliding movement of the leg in the sliding slot also remains the same.
- the pusher block has a plurality of sliding slots and the release block has a plurality of legs which are accommodated in the sliding slots in sliding manner.
- the release block doesn’t have legs to accommodate in the sliding slots of the pusher block.
- the release block has a surface or a notch that comes in contact of the pin’s peripheral surface on movement of the guidewire shaft or the inner shaft.
- a portion of the release block comprises at least a leg, at least a releasing part along its length and at least a detaching end.
- the releasing part and the detaching end construct a detaching mechanism for detaching the engaging part of the frame from the pin.
- the length of the releasing part is sufficient to remain in contact of peripheral surface of the pin during movement of the guidewire shaft or the inner shaft.
- the height of the pin is either less or almost equal to the height of the detaching end.
- the detaching end is situated towards the distal side of the release block and connects to the releasing part and the releasing part is connected to the leg.
- the impact surface of the detaching end that comes in contact of the pin can be selected from a flat surface, an inclined surface, a curved surface, a concave surface, a convex surface, a V-shaped notch, a U-shaped notch, an elliptical surface, an oblong surface, an irregular geometrical surface or a combination thereof.
- the edges, along the length, of the releasing part can be of different shapes selected from a linear edge or a non-linear edge selected from a tapered edge, a curved edge, a concave edge, a convex edge, an elliptical edge, an edge with at least one step change in the width of the leg in circumferential direction, an irregular geometrical edge or a combination thereof.
- the direction of the non-linear edge is such that so the higher extent of non-linearity is either towards the proximal section of the catheter delivery system or towards the detaching end.
- the extent of non-linearity is equally distributed over the length of the releasing part.
- the pins get engaged with the frame of the implant at the time of loading the implant and they get disengaged at the time of deployment.
- the implant doesn’t get disengaged quickly and requires additional maneuvering to get the implant dislodged. This increases procedure time, and the positioning of the implant may also get affected.
- the mechanism of the two-part implant holder helps in ensuring the detachment of the frame of the implant from the pins of the implant holder of the catheter delivery system.
- the release block of the implant holder On moving the guidewire shaft, the release block of the implant holder also moves in longitudinal direction and the releasing part also moves. The movement path is from one end of the releasing part to another end of the releasing part.
- the pins are away from the detaching end and an engaging part of the implant frame is engaged to these pins.
- the engagement mechanism is simply hooking at least a part of the implant frame to the pin.
- the detaching end moves towards the pin and due to linear or non-linear shape of the releasing part, a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin as the detaching end approaches the pin.
- the pusher block is movable due to longitudinally movable inner shaft and on moving the pusher block, the pin moves towards the detaching end and due to linear or non-linear shape of the releasing part, a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin as the detaching end approaches the pin.
- the release block moves on moving the guidewire shaft and the detaching end impacts the peripheral surface of the pin. Due to this sudden impact or shock, the engaging part of the frame detaches from the pin.
- the guidewire shaft is fixed and not movable in longitudinal direction.
- the release block attached to the guidewire shaft is also fixed.
- the pusher block of the implant holder is attached to the inner shaft and the pins are situated on the distal end of the pusher block.
- the inner shaft is movable in longitudinal direction.
- the pusher block is also movable.
- the pin attached to the pusher block On moving the inner shaft, the pin attached to the pusher block also moves along the releasing part present on the release block and disengages the engaging part of the implant frame from the pin.
- the detaching end doesn’t play a functional role in detachment and only the releasing part is functional in the release block.
- the releasing part provides a upside force that acts on the engaging part of the frame and detaches the frame from the pin.
- a seating notch is present that provides a space around the pin for the engaging part of the frame to get accommodated. Also, due to the seating notch, a pushing surface is also created that helps in transferring a force from the catheter shaft to the implant holder and to the engaging part of the frame. The force is applied in longitudinal direction towards the distal section of the catheter delivery system by the physician and the peripheral surface of the pin provides a base support while the pushing surface is applying the force on the engaging part of the frame.
- the legs and the releasing parts are not present in the release block and on moving the pins situated on the pusher block, due to movement of the inner shaft, come in contact of the impact surface of the detaching end and due to this sudden impact or shock, the engaging part of the frame detaches from the pin
- the pins are movable in vertical direction through a slot in the inner shaft.
- the implant holder comprises three parts - a movable pin, a riser and a receiver.
- the riser is attached to the inner shaft and has an inclined surface facing towards the proximal section of the catheter delivery system.
- the receiver is also attached to the inner shaft and has another inclined surface. The another inclined surface faces towards the distal section of the catheter delivery system.
- the movable pin is situated in between the riser and the receiver. Shape of the movable pin is made of a cylindrical part and a hook part.
- the engaging part of the implant frame engages with the cylindrical part of the movable pin.
- the movable pin For disengaging the implant from the movable pin, the movable pin is moved in vertical direction using the riser, the receiver, and longitudinal movement of the guidewire shaft.
- the hook part of the movable pin is parallelogram-shaped situated at an angle with the longitudinal axis of the guidewire shaft.
- One end of the hook part is fixed to the cylindrical part of the movable pin and an other end is situated between the riser and the receiver in such a way so that one side surface of the parallelogram is in sliding contact with the inclined surface of the riser and other side surface is in sliding contact with the inclined surface of the receiver.
- inclined surfaces of the riser and the receiver are parallel to each other i.e., on bringing closer, the inclined surfaces of the riser and the receiver contact each other at 0° angle.
- the hook part of the movable pin is not fixed to any surface.
- the receiver On longitudinal movement of the guidewire shaft towards the distal section, the receiver moves forward and forces the hook part of the movable pin to move towards the guidewire shaft.
- the receiver On forward movement of the guidewire shaft, the receiver also moves forward and applies a downward force on the inclined surface of the flat part. This downward force pushes the movable pin to move downwards in the space created and the cylindrical part of the movable pin gets accommodated in the slot in the inner shaft.
- the riser On longitudinal movement of the guidewire shaft towards the proximal section, the riser also moves towards the proximal section and applies an upward force on the other inclined surface of the flat part and helps in upward movement of the movable pin through the slot in the inner shaft.
- the pin can be of various sizes and shapes, specifically selected from, but not limited to, rectangular, circular, D-shaped, ovel, hexagonal, pentagonal, octagonal, triangular configurations and a combination thereof.
- the implant holder comprises at least one radiopaque marker.
- the radiopaque marker is situated on the peripheral surface of the implant holder and its components including, but not limited to, the pusher block, the release block, the pin, the riser, the receiver, the legs, the sliding slot, the slot, the releasing part or a combination thereof.
- shape of the radiopaque marker present on the percutaneous catheter is selected from a circle, rectangular, square, oval, hexagonal, oblong, star-shaped, diamond-shaped, a circumferential ring, an irregular-shaped circumferential ring, an incomplete circumferential ring, an incomplete irregular circumferential ring or a combination thereof.
- the implant is used in treating any abnormality or in any medical procedure related to heart, kidney, lever, brain, pancreas, lungs, digestive system, endovascular system, any tract, duct or any conduit in animal or human body. More specifically, the implant can be deployed in an artery, vein, heart valves, esophageal duct, bile duct, urinary tract, alimentary tract, tracheobronchial tree, cerebral aqueduct or genitourinary system of an animal or human body.
- the present subject matter also envisages a method for fabricating the implant holder as explained above.
- the method requires loading of a medically clean and approved workpiece in a designing instrument.
- the workpiece can be in shape of a hollow circular tube, or a solid cylinder, or a sheet.
- the workpiece is prepared from a composition in powder form or prepared from a composition in liquid form.
- the required design of the implant holder is set-up or uploaded in the designing instrument, such as a computer-numerical controlled (CNC) machine for manufacturing. Subsequently, the required design is carved out of the workpiece to fabricate the implant holder.
- CNC computer-numerical controlled
- the fabrication technique used in the designing instrument is selected from laser fabrication, chemical-etching, mechanical machining, chemical machining, metal injection molding, vacuum casting, milling, photochemicaletching, electro-discharge machining, 3D-printing technique, additive manufacturing technique or a combination thereof.
- the implant holder is fabricated by slitting a metallic hollow circular tube with a laser beam, the laser beam following a predefined cutting contour to produce the design of the implant holder.
- the implant holder is be manufactured using 3D printing technique or additive manufacturing. Once the implant holder has been manufactured, the undesired material is removed from the surface of the implant holder for finishing. The cleaned and finished implant holder can then be polished or coated with an appropriate coating.
- the implant holder can be coated with an anti-reactive agent which prevents it from reacting with the atmosphere where either the implant is stored or deployed.
- the implant holder can be covered with a medicinal substance or radiopaque substance, depending on the purpose, mode, and location of deployment of the implant holder.
- 3D printing technique can be selected from but not limited to Stereolithography (SLA), Digital light processing (DLP), Fused deposition modelling (FDM), Selective laser sintering (SLS), Selective laser melting (SLM), Electronic beam melting (EBM), Laminated object manufacturing (LOM), Polyjet technology or a combination of thereof.
- SLA Stereolithography
- DLP Digital light processing
- FDM Fused deposition modelling
- SLS Selective laser sintering
- SLM Selective laser melting
- EBM Electronic beam melting
- LOM Laminated object manufacturing
- Polyjet technology or a combination of thereof.
- Fig. 1 represents, according to an embodiment of the present disclosure, a typical catheter delivery system.
- the catheter delivery system (100) comprises a distal section (160), a middle section (150), and a proximal section (140).
- the proximal section (140) remains outside the human body and comprises a handle (120) to control the movements at the distal section (160) of the catheter.
- the distal section comprises a tip (126), an inner shaft (104), a guidewire shaft (114), a implant holder (102) and a capsule (128).
- the middle section (150) is connected proximally with the handle (120) and distally it connects to the distal section (160).
- Fig. 1A represents a magnified view of a part of the handle (120) assembly that has a rotary knob (108).
- Fig. IB represents a side cross-sectional view of a part of the handle (120) that comprises a rotary knob (108).
- the rotary knob (108) is connected to a threaded shaft (106) that is fixed to the guidewire shaft (114).
- the guidewire shaft (114) goes through the inner shaft (104) and extends till the tip (126) in the distal section (160).
- the distal section (160) mainly comprises the tip (126), the guidewire shaft (114), the implant holder (102) and the capsule (128).
- the capsule (128) provides an inside space where the implant is loaded in compressed form and the capsule (128) helps in retaining the implant in compressed form.
- the implant is situated over the guidewire shaft (114) and in between the tip (126) and the implant holder (102).
- the implant holder (102) is situated on the guidewire shaft (114) and situated inside the capsule (128) at a proximal end of the distal section (160).
- the guidewire shaft (114) is movable in longitudinal direction due to rotational movement of the rotary knob (108).
- Fig. 1C represents a side cross-sectional view of a part of the handle (120) that comprises a rotary knob (108).
- the rotary knob (108) is connected to a threaded shaft (106) that is fixed to the inner shaft (104).
- the guidewire shaft (114) goes through the inner shaft (104) and extends till the tip (126) in the distal section (160).
- the inner shaft (104) is movable in longitudinal direction due to rotational movement of the rotary knob (108).
- the implant holder (102) is a two-part hub-like cylindrical structure and comprises of a pusher block (112) and attached to the inner shaft (104) whereas a release block (116) is attached to the guidewire shaft (114).
- the release block has a plurality of legs (130).
- the pusher block (112) has a plurality of pins (110) and a plurality of sliding slots (122).
- the legs (130) are arranged in the sliding slots (122) in sliding manner.
- Each pin (110) is placed between two adjacent legs (130).
- the pusher block (112) also has a seating notch (136) around the pin (110) that accommodates the engaging part of the frame.
- a pushing surface (138) is created that helps in transferring of the to the engaging part of the frame wherein the force is applied by the physician in longitudinal direction of the catheter delivery system.
- the release block (116) moves in longitudinal direction and the legs (130) slide in the sliding slots (122).
- at least one leg (130) has a releasing part (124) along its length having a symmetric or asymmetric shape.
- the releasing part (124) has a detaching end (132) that has a height almost equal to the height of the pin.
- the pins (110) are engaged with frame of the implant.
- the release block (116) of the implant holder (102) On moving the guidewire shaft ( 114) in longitudinal direction, the release block (116) of the implant holder (102) also moves and so does the releasing part (124). In initial position, the pins (110) are away from the detaching end (132). On moving the release block (116), the detaching end (132) moves towards the pin (110) and due to shape of the releasing part (124), a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin (110) as the detaching end (132) approaches the pin (110).
- the detaching end (132) is towards the distal section (160) of the catheter delivery system.
- the pusher block (112) has a pushing surface (138) and seating notch (136) between the pin (110) and the pushing surface (138).
- FIG. 2C shows a impact surface (139) present at a detaching end (138).
- Fig. 3 and 3A represent another embodiment of the present disclosure where in initial position, the detaching end (132) is towards the proximal section
- the guidewire shaft (114) is fixed and not movable in longitudinal direction.
- the release block (116) attached to the guidewire shaft (114) is also fixed.
- the rotary knob in the handle (120) is connected to a threaded shaft that is fixed to the inner shaft ( 104) .
- the pusher block (112) of the implant holder (102) is also attached to the inner shaft (104).
- the inner shaft (104) is movable in longitudinal direction and the pusher block (112) also moves.
- the pins (110) attached to the pusher block (112) also moves along the releasing part (124) present on the release block (116), towards the detaching end (132), and disengages the engaging part of the implant frame from the pin (110).
- the pins (110) move towards the detaching end (132) and due to inclined shape ofthe releasing part (124), a vertical force is applied on the engaging part of the implant frame and the engaging part comes out of the pin (110).
- the inner shaft (104) is not movable, hence, the pins (110) attached to the pusher block (112) are also not movable.
- the guidewire shaft (114) is movable in longitudinal direction due to rotational motion of the rotary knob (108).
- the release block (116) also moves in longitudinal direction due to movement of the guidewire shaft (114) movement, and the concave-shaped edge of the releasing part ( 124) applies an uplifting force on the engaging part of the frame to aid its detachment from the pins (110).
- Fig. 6 and 6A depict yet another embodiment of the present disclosure, wherein the inner shaft (104) is not movable, hence, the pins (110) attached to the pusher block (112) are also not movable.
- the guidewire shaft (114) is movable in longitudinal direction due to rotational motion of the rotary knob (108).
- the release block (116) also moves in longitudinal direction due to movement of the guidewire shaft (114) movement, and the linear edge, with no angle change with respect to the longitudinal axis ofthe guidewire shaft, ofthe releasing part (124) applies a frictional force on the engaging part of the frame to aid its detachment from the pins (110).
- the inner shaft (104) is not movable, hence, the pins (110) attached to the pusher block (112) are also not movable.
- the guidewire shaft (114) is movable in longitudinal direction due to rotational motion of the rotary knob (108).
- the release block (116) also moves in longitudinal direction due to movement of the guidewire shaft (114) movement, and the convex-shaped edge of the releasing part ( 124) applies an uplifting force on the engaging part of the frame to aid its detachment from the pins (110).
- the inner shaft (104) is not movable, hence, the pins (110) attached to the pusher block (112) are also not movable.
- the guidewire shaft (114) is movable in longitudinal direction due to rotational motion of the rotary knob (108).
- the release block optionally, does not have the legs and/or the releasing part.
- the release block (116) also moves in longitudinal direction due to movement of the guidewire shaft (114) movement, and the U-shaped notch of the releasing part (124) comes in contact of the peripheral surface of the pins (110) and the impact surface ( 118) of the detaching end (132) applies a shock or impact on the pin that aids in detachment of the engaging part of the frame the pins (110).
- Fig. 9 to 9F depict yet another embodiment of the present invention, wherein, due to longitudinal movement of the guidewire shaft (114), a movable pin (170) moves vertical to the longitudinal axis through a slot (134) in the inner shaft (104).
- the movable pin (170) comprises a cylindrical part (176) and a hook part (178).
- the hook part (178) is parallelogram-shaped and has parallel inclined side surfaces. These side surfaces are in sliding contact with a riser (172) and a receiver (174).
- the riser (172) and the receiver (174) also have at least one inclined side surface which are also parallel to each other, parallel to the inclined side surfaces of the hook part (178).
- the riser (172) and the receiver (174) are in sliding contact with the inclined side surfaces of the hook part (178).
- the riser (172) and the receiver (174), both are attached to the inner shaft (104) whereas the movable pin (170) is not fixed to any part of the catheter delivery system.
- the cylindrical part (176), whose one end is attached to the hook part (178), is placed inside the slot (134) in the inner shaft (104).
- the movable pin (170) is situated between the riser (172) and the receiver (174).
- the engaging part of the implant frame engages with the cylindrical part (176) of the movable pin (170).
- the receiver (174) moves forward and forces the hook part (178) of the movable pin (170) to move towards the guidewire shaft (114).
- the receiver (174) On forward movement of the guidewire shaft (114), the receiver (174) also moves forward and applies a downward force on the inclined surface of the hook part (178). This downward force pushes the movable pin ( 170) to move downwards in the space created and the cylindrical part (176) of the movable pin (170) gets accommodated in the slot (134) in the inner shaft (104).
- the riser (172) On longitudinal movement of the guidewire shaft (114) towards the proximal section (140), the riser (172) also moves towards the proximal section (140) and applies an upward force on the other inclined surface of the hook part (178) and helps in upward movement of the movable pin (170) through the slot (134) in the inner shaft (104).
- the movable pin (170) is moved in vertical downward direction using the riser (172), the receiver (174), and longitudinal movement of the guidewire shaft (114).
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA3192312A CA3192312A1 (en) | 2022-05-18 | 2022-06-16 | Implant detachment mechanism |
CN202280005887.6A CN117425451A (en) | 2022-05-18 | 2022-06-16 | Implant detachment mechanism |
AU2022331908A AU2022331908A1 (en) | 2022-05-18 | 2022-06-16 | Implant detachment mechanism |
EP22734086.6A EP4297696A1 (en) | 2022-05-18 | 2022-06-16 | Implant detachment mechanism |
US17/816,560 US20230372682A1 (en) | 2022-05-18 | 2022-08-01 | Implant detachment mechanism |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN202221028620 | 2022-05-18 | ||
IN202221028620 | 2022-05-18 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/816,560 Continuation US20230372682A1 (en) | 2022-05-18 | 2022-08-01 | Implant detachment mechanism |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2023223332A1 true WO2023223332A1 (en) | 2023-11-23 |
Family
ID=82483347
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IN2022/050550 WO2023223332A1 (en) | 2022-05-18 | 2022-06-16 | Implant detachment mechanism |
Country Status (1)
Country | Link |
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WO (1) | WO2023223332A1 (en) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012166804A1 (en) * | 2011-06-03 | 2012-12-06 | Reverse Medical Corporation | Embolic implant and method of use |
US20180325667A1 (en) * | 2012-11-09 | 2018-11-15 | Medtronic CV Luxembourg S.a.r.l. | Medical Device Delivery System and Methods of Delivering Medical Devices |
US20200000589A1 (en) * | 2017-03-08 | 2020-01-02 | Epygon | Delivery System for Transcatheter Prosthetic Heart Valves |
WO2020202046A1 (en) * | 2019-04-03 | 2020-10-08 | V-Wave Ltd. | Systems for delivering implantable devices across an atrial septum |
-
2022
- 2022-06-16 WO PCT/IN2022/050550 patent/WO2023223332A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012166804A1 (en) * | 2011-06-03 | 2012-12-06 | Reverse Medical Corporation | Embolic implant and method of use |
US20180325667A1 (en) * | 2012-11-09 | 2018-11-15 | Medtronic CV Luxembourg S.a.r.l. | Medical Device Delivery System and Methods of Delivering Medical Devices |
US20200000589A1 (en) * | 2017-03-08 | 2020-01-02 | Epygon | Delivery System for Transcatheter Prosthetic Heart Valves |
WO2020202046A1 (en) * | 2019-04-03 | 2020-10-08 | V-Wave Ltd. | Systems for delivering implantable devices across an atrial septum |
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