CN112603599A - Implant delivery system - Google Patents
Implant delivery system Download PDFInfo
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- CN112603599A CN112603599A CN202011642708.9A CN202011642708A CN112603599A CN 112603599 A CN112603599 A CN 112603599A CN 202011642708 A CN202011642708 A CN 202011642708A CN 112603599 A CN112603599 A CN 112603599A
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- handle
- implant
- rod
- push rod
- delivery system
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Images
Classifications
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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
- A61F2/02—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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
-
- 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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
-
- 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
- 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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2002/249—Device completely embedded in the heart wall
Abstract
The invention provides an implant conveying system which comprises a first handle connected with an outer sheath tube, a second handle connected with an inner push rod, and an implant loading device arranged at the far end of the inner push rod, which is far away from the second handle, wherein the outer sheath tube can axially adjust and move relative to the first handle, and the inner push rod can axially adjust and move relative to the second handle; and a connecting assembly is further arranged between the first handle and the second handle, and when the first handle and the second handle are connected through the connecting assembly, the inner push rod penetrates through the outer sheath. The implant delivery system provided by the invention can effectively control the speed and distance of implant release at each stage, and compared with the prior art that the implant is directly pushed manually, the implant delivery system realizes the controllability of implant release and effectively prevents the release accident caused by the control error formed by pushing the inner push rod or withdrawing the outer sheath tube in the implant release process.
Description
Technical Field
The invention relates to the technical field of medical instrument design, in particular to an implant conveying system.
Background
Heart failure (heart failure) refers to a heart circulatory disturbance syndrome caused by venous return blood volume not being discharged from the heart sufficiently due to the failure of the systolic function and/or diastolic function of the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system. Heart failure is a serious disease with high incidence and mortality, and can be classified into left heart failure, right heart failure and whole heart failure according to the occurrence part of the heart failure, and also classified into systolic heart failure and diastolic heart failure according to the clinical manifestations of the heart failure, wherein the Diastolic Heart Failure (DHF) accounts for about half of all patients with heart failure. More than 1200 thousands of heart failure patients exist in China, namely the incidence rate of heart failure is about 2-3%, wherein about 600 thousands of diastolic heart failure patients exist, heart failure of old people is mainly diastolic heart failure, and the number of the diastolic heart failure patients of the old people is 66.99% of the total number of the diastolic heart failure patients.
When the heart failure is treated, the existing various means have defects, and the drug treatment cannot fundamentally remove the cause of the disease and has the possibility of repeated attack; cardiac Resynchronization Therapy (CRT), ineffective in at least 20% of patients with heart failure; left Ventricular Assist Device (LVAD) operation needs extracorporeal circulation, which not only has high incidence rate of large trauma and complications, but also is expensive and difficult to obtain; heart transplantation, which can fundamentally solve the problem, but the donor source is very limited and expensive.
The method of using an atrial shunt is a new approach to treating heart failure by making an ostium at the interatrial septum between the left atrium and the right atrium of a patient and implanting a shunt device to create a shunt between the left and right atrium, and implantable atrial shunt devices have been successfully used in patients with severe symptomatic heart failure. By transferring or shunting blood from the Left Atrium (LA) to the Right Atrium (RA), the pressure in the left atrium is reduced or prevented from rising (left atrial decompression). Such regimen may prevent, alleviate or limit symptoms, signs and syndromes associated with pulmonary congestion, including severe shortness of breath, pulmonary edema, hypoxia, and the like.
Implantation of the shunt device requires manipulation by the delivery system. Generally, the implant is delivered to the interatrial septum location along an introducer sheath by a delivery system, which, upon movement of the catheter, releases the left atrial portion of the implant followed by the right atrial portion. Because implantation of an atrial shunt requires sequential release of the left and right atrial portions of the implant by controlling the relative motion between the different components of the delivery system multiple times, the difficulty of control is great and the degree of control accuracy directly affects the release. If the pushing distance is too long, the implant risks falling into the left atrium, and if the pushing distance is too short, release of the right atrial portion is affected. In the prior art, the manual control is only realized by depending on the experience of an operator, which easily causes positioning errors, leads to falling of the implant and failure of the operation.
Therefore, there is a need for a delivery system with controllable and easily controllable release rate and release distance to ensure the accuracy of the implantation position and improve the success rate of the surgery.
Disclosure of Invention
The invention provides an implant delivery system, which comprises a first handle connected with an outer sheath tube, a second handle connected with an inner push rod, and an implant loading device arranged at the far end of the inner push rod far away from the second handle, wherein the outer sheath tube can axially adjust and move relative to the first handle, and the inner push rod can axially adjust and move relative to the second handle; and a connecting assembly is further arranged between the first handle and the second handle, and when the first handle and the second handle are connected through the connecting assembly, the inner push rod penetrates through the outer sheath.
In some embodiments, the proximal end of the outer sheath and the proximal end of the inner push rod are axially adjustably mounted to the first handle portion and the second handle portion, respectively, by fine adjustment assemblies; in some embodiments, the fine tuning component comprises:
one end of the adjusting rod is axially movably arranged in the first handle/the second handle, and the other end of the adjusting rod is provided with an adjusting part; the near end of the outer sheath tube/the inner push rod is coaxially connected with the adjusting rod;
and the adjusting piece is arranged on the first handle/the second handle, is connected with the adjusting part in a matching way, and drives the adjusting piece to drive the adjusting rod to move axially.
In some embodiments, the adjusting portion is a threaded rod, the adjusting member is a threaded knob, the threaded knob is sleeved on the threaded rod and connected with the threaded rod in a threaded manner, and the threaded knob is axially limited and circumferentially rotatably mounted on the first handle/the second handle.
In some embodiments, the adjusting lever is provided with at least one guiding protrusion, the guiding groove is parallel to the axial direction of the adjusting lever, and the corresponding position of the first handle/the second handle is provided with a guiding groove, and the guiding protrusion is arranged in the guiding groove and can move along the guiding groove.
In some embodiments, a locking device is disposed between each of the first and second handles and the adjustment lever for limiting axial movement of the adjustment lever relative to the first and second handles.
In some embodiments, the locking device comprises a locking ring, the locking ring is sleeved on one circle of the adjusting rod, a locking ring elastic piece is arranged between one side of the locking ring and the inner wall of the first handle/the second handle, and a key extending out of the first handle/the second handle is arranged on the other opposite side;
the locking part is arranged on the inner ring of the locking ring and opposite to the elastic piece, the locking part is abutted against the adjusting rod under the action of the elastic piece of the locking ring to realize locking, the key is pressed to drive the locking ring to move, and the locking part is separated from the adjusting rod to realize unlocking.
In some embodiments, when the adjusting part on the adjusting rod is a threaded rod, the locking part is a threaded part matched with the threaded rod, and the threaded part and the threaded rod are matched together to realize locking.
In some embodiments, the coupling assembly includes a first hook structure disposed on the first handle and a second hook structure disposed on the second handle, and an unlocking structure disposed on the first handle or the second handle;
the first handle is coaxially butted with the second handle, and the first hook-shaped structure and the second hook-shaped structure are buckled together to realize fixation; and pushing the unlocking structure, wherein the unlocking structure pushes the first hook structure or the second hook structure, so that the first hook structure is separated from the second hook structure to realize unlocking.
In some embodiments, the unlocking structure comprises:
the shell of the second handle is provided with a sliding groove, and the sliding block is arranged in the sliding groove;
the first inclined surface structure is positioned in the second handle and is connected with the sliding block;
a second ramp structure disposed on the second hook structure;
after the first hook-shaped structure and the second hook-shaped structure are connected together, the first inclined plane structure is abutted against the second inclined plane structure; and sliding the sliding block, wherein the first inclined surface structure slides along the second inclined surface structure, and the second hook-shaped structure is pushed to move along the radial direction of the second handle to be separated from the second hook-shaped structure.
In some embodiments, a sliding block elastic piece is arranged between the sliding block and the sliding groove, when the sliding block moves along the sliding groove for unlocking, the sliding block elastic piece deforms for energy storage, and after unlocking is completed, the sliding block resets under the action of the sliding block elastic piece.
In some embodiments, the implant loading device comprises a loading catheter disposed on the distal end of the inner push rod, and the distal end of the inner push rod is axially movably disposed through the loading catheter; the distal end part of the inner push rod is also provided with a fixing piece for fixing the implant.
In some embodiments, a reinforcing tube is further disposed on the proximal end of the inner ram adjacent the second handle.
Due to the adoption of the technical scheme, compared with the prior art, the invention has the following advantages and positive effects:
according to the implant delivery system provided by the invention, the outer sheath tube and the inner push rod are independently arranged and can independently control movement, so that the outer sheath tube and the inner push rod can be respectively used as a catheter sheath and a push rod; the outer sheath tube and the inner push rod can be connected through the first handle, the second handle and the connecting assembly, and the first handle, the second handle and the connecting assembly are matched to complete the stable and accurate conveying function of the implant, so that the application range is greatly widened; further, when the first handle and the second handle are used in combination, the implant is loaded in the implant loading device at the distal end of the inner push rod, the implant loading device with the implant and the inner push rod are inserted into the outer sheath, and the inner push rod pushes the implant from the implant loading device into the outer sheath; the inner push rod pushes the implant to advance towards the far end along the outer sheath tube until the first handle and the second handle are connected together to form a complete handle; the inner push rod is then adjusted to move axially distally relative to the second handle while the outer sheath is relatively stationary to push the implant portion out of the distal end of the outer sheath, and the outer sheath is adjusted to move axially proximally relative to the first handle while the inner push rod is relatively stationary to release the remaining portion of the implant out of the distal end of the outer sheath. Compared with the prior art in which the implant is directly pushed manually, the implant pushing mode can effectively control the speed and distance of implant release at each stage, realize the controllability of implant release, and effectively prevent the release accident caused by the control error formed by pushing the inner push rod or withdrawing the outer sheath tube in the implant releasing process.
Drawings
The above and other features and advantages of the present invention will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a schematic view of the overall structure of an implant delivery system provided by the present invention;
FIG. 2 is a schematic view of the inner push rod of the present invention loaded into the outer sheath;
FIG. 3 is a schematic view of the present invention with the inner shaft separated from the outer sheath;
FIG. 4 is a cross-sectional view of an implant delivery system provided by the present invention;
FIG. 5 is a partial cross-sectional view of a trim assembly, locking device of the present invention;
FIG. 6 is a schematic view of the present invention with the adjustment lever locked;
FIG. 7 is a schematic view of the present invention after the adjustment lever is unlocked;
FIG. 8 is a schematic view of a connecting assembly according to the present invention;
FIG. 9 is a schematic view of the structure of the implant loading device of the present invention;
FIG. 10 is a schematic view of the present invention with an implant loaded on a fixture;
FIG. 11 is a schematic view of a heart shunt device of the present invention;
FIG. 12 is a schematic view of a cardiac shunt device of the present invention mounted on the atrial septum.
Detailed Description
The present invention will be described in more detail below with reference to the accompanying drawings, which illustrate embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of hierarchical regions may be exaggerated for clarity.
It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.
Referring to fig. 1-10, the present invention provides an implant delivery system comprising a first handle 1 to which an outer sheath 3 is connected, a second handle 2 to which an inner push rod 4 is connected, an implant loading device disposed on a distal end of the inner push rod 4 remote from the second handle, and the outer sheath 3 being axially adjustably movable relative to the first handle 1 and the inner push rod 4 being axially adjustably movable relative to the second handle 2; still be provided with coupling assembling 5 between first handle 1 and the second handle 2, after first handle 1 is connected through coupling assembling 5 with second handle 2, interior push rod 4 wears to establish in sheath pipe 3.
Wherein, one end close to the operator is defined as a near end, and the other end far away from the operator is defined as a far end; namely, one end of the invention close to the first handle and the second handle is a near end, and the other opposite end is a far end.
According to the implant delivery system provided by the invention, the outer sheath tube 3 and the inner push rod 4 are independently arranged and can independently control movement, so that the outer sheath tube and the inner push rod can be respectively used as a catheter sheath and a push rod; the outer sheath tube 3 and the inner push rod 4 can be connected through the first handle, the second handle and the connecting assembly, the first handle, the second handle and the connecting assembly are matched to complete stable and accurate conveying functions of the implant, and the application range is greatly widened.
Further, when the first handle 1 and the second handle 2 are used in cooperation, the implant is loaded in the implant loading device 11 at the distal end of the inner push rod 4, the loading device with the implant and the inner push rod are inserted into the outer sheath tube 3, and the inner push rod pushes the implant from the implant loading device into the outer sheath tube; the inner push rod pushes the implant to advance towards the far end along the outer sheath tube until the first handle and the second handle are connected together to form a complete handle; the inner push rod is then adjusted to move axially distally relative to the second handle 2, with the outer sheath relatively stationary, to push the implant portion out of the distal end of the outer sheath, and the outer sheath is adjusted to move axially proximally relative to the first handle 1, with the inner push rod relatively stationary, to cause the remaining portion of the implant to be released out of the distal end of the outer sheath. Compared with the prior art in which the implant is directly pushed manually, the implant pushing mode can effectively control the speed and distance of implant release at each stage, realize the controllability of implant release, and effectively prevent the release accident caused by the control error formed by pushing the inner push rod in the implant releasing process.
The present invention provides an implant delivery system suitable for delivery of various types of implants, and is not limited herein; the device is particularly suitable for delivery of a heart shunt device, and is described in detail below as being applied to a heart shunt device.
In this embodiment, the proximal end of the outer sheath tube 3 is axially adjustably mounted to the first handle 1 by a first fine adjustment assembly.
Specifically, as shown in fig. 4, the first fine adjustment assembly includes a first adjustment rod 12 and a first adjustment member 6, a proximal end of the first adjustment rod 12 is axially movably mounted in the first handle 1, and a distal end thereof is provided with a first adjustment portion 1201; the near end of the outer sheath tube 3 is coaxially connected with the first adjusting rod 12, and a through hole communicated with the outer sheath tube 3 is arranged on the first adjusting rod 12 in the axial direction; the first adjusting part 6 is mounted on the first handle 1 and is connected with the first adjusting part 1201 in a matching mode, and the first adjusting part 6 is driven to drive the first adjusting rod to move axially, so that the outer sheath tube 3 is driven to move axially to be adjusted. The embodiment realizes the precise control of the moving speed and the moving distance when the outer sheath tube 3 moves axially relative to the first handle 1 through the first fine adjustment component, so that the release speed of the implant can be controlled, and the problem of displacement caused by the rapid release of the implant is prevented; in addition, in the embodiment, the first adjusting rod and the sheath base of the outer sheath 3 are combined into a whole, so that the basic sheath base function is satisfied, fine adjustment and movement of the outer sheath are realized, and the space of the first handle 1 is saved to a great extent.
The proximal end 1203 of the first adjusting rod 12 is axially movably mounted on the first handle 1, and a hemostatic valve is additionally arranged on the port of the first adjusting rod, so that the first adjusting rod can be used as a sheath seat for independent use.
One or more first guide protrusions 1202 are further arranged on the outer wall of the first adjusting rod 12, matched first guide grooves are arranged on the inner wall of the first handle 1 corresponding to the first guide protrusions 1202, and the first guide protrusions 1202 and the first guide grooves are arranged in parallel with the axial extension of the outer sheath tube 3; the first guide protrusion 1202 is disposed in the first guide groove and is movable along the first guide groove. In the embodiment, the first guide protrusion 1202 and the first guide groove are cooperatively arranged, so that the axial linear motion of the first adjusting rod 12 and the outer sheath tube 3 is ensured, and the function of radial position limitation is also realized. Of course, in other embodiments, the guiding structure of the first adjusting lever 12 and the first handle 1 is not limited to the above, and for example, the guiding structure may also be a guiding protrusion structure provided on the first handle 1 or a guiding groove structure provided on the first adjusting lever 12, which is not limited herein and can be adjusted according to specific situations.
Further, a first convex ring 101 is arranged on the inner wall of the first handle 1, a first guide groove is arranged on the inner wall of the first convex ring 101, a first adjusting rod 12 is arranged in the first convex ring 101 in a penetrating manner, and a first guide protrusion 1202 is arranged in the first guide groove; the first adjusting lever 12 is further provided with two first limiting rings 1203, the two first limiting rings 1203 are located at two ends of the first guiding protrusion 1202 and located at two axial sides of the first protruding ring 101, and the first limiting rings 1203 are arranged to limit the distance of the first adjusting lever 12 moving axially relative to the first handle 1.
Wherein, first regulating part 1201 adopts the threaded rod, and first regulating part 6 adopts the screw thread knob, and the screw thread knob cover is established on the threaded rod and threaded connection, and the screw thread knob axial is spacing, the rotatable installation of circumference on first handle 1, clockwise or anticlockwise rotation screw thread knob can control the back-and-forth movement of sheath pipe. Furthermore, the first handle 1 is provided with a recess so that the threaded knob at least partially extends out of the first handle, thereby facilitating the control of the threaded knob by an operator; further, concave-convex structures are added on the surface of the threaded knob so as to increase the friction force during contact.
Of course, in other embodiments, the implementation of the first adjusting portion and the first adjusting member is not limited to the matching scheme of the threaded rod and the threaded knob, and may also be other fine adjustment structures, such as the matching scheme of the rack and the gear, or the matching scheme of the slide rail type, or the matching scheme of the ratchet wheel type, as long as the rotation and moving processes can be slowly controlled, and the implementation scheme is not limited herein, and can be adjusted according to specific situations.
In the embodiment, a first locking device 8 is further arranged between the first handle 1 and the first adjusting rod 12, and the first locking device 8 is used for limiting the axial movement of the first adjusting rod 12 relative to the first handle 1; normally, the first locking device 8 realizes the fixed setting of the sheath tube 3 relative to the first handle 1, when the sheath tube 3 needs to be adjusted, the first locking device 8 is unlocked, and unnecessary handle operation and sheath tube movement can be avoided through the setting of the first locking device 8.
Specifically, with reference to fig. 5-7, the first locking device 8 includes a first locking ring 801, the first locking ring 801 is sleeved on a circle of the threaded rod of the first adjusting rod 12, a first locking ring elastic member 802 is disposed between one side of the first locking ring and the inner wall of the first handle 1, and a button 804 extending out of the first handle 1 is disposed on the opposite side; a first locking portion 803 is arranged on the inner ring of the first locking ring 801 opposite to the first locking ring elastic piece 802, the first locking portion 803 is abutted to the threaded rod under the action of the first locking ring elastic piece 802 to achieve locking, as shown in fig. 6, the first key 804 is pressed to drive the first locking ring 801 to move, and the first locking portion 803 is separated from the threaded rod to achieve unlocking, as shown in fig. 7.
Further, the first locking ring elastic member 802 may be implemented by a spring, and the like, which is not limited herein.
Further, the first locking portion 803 is a threaded portion matched with the threaded rod, and the threaded portion and the threaded rod are matched together to realize locking. Of course, in other embodiments, the first locking portion 803 may also be a protrusion that is engaged in the threaded portion of the threaded rod, and the like, and is not limited herein and may be adjusted according to specific situations.
Of course, the implementation of the first locking device 8 in other embodiments is not limited to the above, and can be adjusted according to specific situations; in some embodiments, when the first fine tuning assembly has a self-locking function, the arrangement of the first locking device 8 can be omitted, and is not limited herein and can be adjusted according to specific situations.
In this embodiment, the proximal end of the inner push rod 4 is axially adjustably mounted to the second handle 2 by a second fine adjustment assembly.
Specifically, as shown in fig. 4, the second fine adjustment assembly comprises a second adjustment rod 13 and a second adjustment member 7, wherein the distal end of the first adjustment rod 13 is axially movably mounted in the second handle 2, and the proximal end is provided with a second adjustment portion 1301; the near end of the inner push rod 4 is coaxially and fixedly connected with a second adjusting rod 13; the second adjusting part 7 is mounted on the second handle 2 and is connected with the second adjusting part 1301 in a matching manner, and the second adjusting part 7 is driven to drive the second adjusting rod 13 to move axially, so that the inner push rod 4 is driven to move axially for adjustment. The embodiment realizes the accurate control of the moving speed and the moving distance of the inner push rod 4 relative to the second handle 2 during the axial movement through the second fine adjustment component, thereby ensuring the safety and the accuracy of the releasing process.
One or more second guide protrusions 1302 are further arranged on the outer wall of the second adjusting rod 13, matched second guide grooves 201 are arranged on the inner wall of the second handle 2 corresponding to the second guide protrusions 1302, and the second guide protrusions 1302 and the second guide grooves 201 are arranged in parallel with the axial extension of the inner push rod 4; the second guide protrusion 201 is disposed in the second guide groove 1302 and is movable along the second guide groove 1302. In the embodiment, the second guide groove 1302 and the second guide protrusion 201 are cooperatively arranged, so that the axial linear motion of the second adjusting rod 13 and the inner push rod 4 is ensured, and meanwhile, the function of radial limiting is also realized. Of course, in other embodiments, the guide structure between the second adjustment lever 13 and the second handle 2 is not limited to the above, and may be, for example, a guide projection structure provided on the second handle 2 or a guide groove structure provided on the second adjustment lever 13, which is not limited herein and may be adjusted according to specific situations.
Further, a second convex ring 201 is arranged on the inner wall of the second handle 2, a second guide groove is arranged on the inner wall of the second convex ring 201, the second adjusting rod 13 is arranged in the second convex ring 201 in a penetrating manner, and the second guide protrusion 1302 is arranged in the second guide groove; the second adjusting lever 13 is further provided with two second limiting rings 1303, the two second limiting rings 1303 are located at two ends of the second guiding protrusion 1302 and located at two axial sides of the second convex ring 201, and the second limiting rings 1303 are arranged to limit the axial movement distance of the second adjusting lever 13 relative to the second handle 2.
The second adjusting part 1301 is a threaded rod, the second adjusting part 7 is a threaded knob, the threaded knob is sleeved on the threaded rod and connected in a threaded mode, the threaded knob is axially limited and circumferentially rotatably mounted on the second handle 2, and the threaded knob is rotated clockwise or anticlockwise to control the back and forth movement of the inner push rod. Furthermore, the second handle 2 is provided with a recess so that the threaded knob at least partially extends out of the second handle 2, thereby facilitating the control of the threaded knob by an operator; further, concave-convex structures are added on the surface of the threaded knob so as to increase the friction force during contact.
Of course, in other embodiments, the implementation of the second adjusting portion and the second adjusting member is not limited to the matching scheme of the threaded rod and the threaded knob, and may also be other fine adjustment structures, such as the matching scheme of the rack and the gear, or the matching manner of the slide rail type, or the matching manner of the ratchet wheel type, as long as the rotation and moving processes can be slowly controlled, and the implementation is not limited herein, and can be adjusted according to specific situations.
In this embodiment, a reinforcing tube 10 is further disposed on the proximal end of the inner push rod 4 connected to the second handle 2, and the reinforcing tube 10 is used for increasing the rigidity of the proximal end of the inner push rod 4.
The reinforcing tube 10 can be made of a stainless steel metal material with good biocompatibility or a high polymer material with high hardness, so that the problem that the inner push rod 4 cannot be conveyed continuously due to bending caused by insufficient rigidity of the inner push rod when pushed can be solved.
The reinforcing pipe 10 can be connected with the inner push rod 4 by splicing or the like, or can be connected by sleeving or the like, and is not limited here and can be adjusted according to specific conditions.
In the embodiment, a second locking device 9 is further arranged between the second handle 2 and the second adjusting rod 13, and the second locking device 9 is used for limiting the second adjusting rod 13 to move axially relative to the second handle 2; normally, the second locking device 9 realizes the fixed arrangement of the inner push rod 4 relative to the second handle 2, when the outer push rod 4 needs to be adjusted, the second locking device 9 is unlocked, and unnecessary handle operation and movement of the inner push rod can be avoided through the arrangement of the second locking device 9.
Specifically, the second locking device 9 comprises a second locking ring, the second locking ring is sleeved on a circle of the threaded rod of the second adjusting rod 13, a second locking ring elastic part is arranged between one side of the second locking ring and the inner wall of the second handle 2, and a key extending out of the second handle 2 is arranged on the opposite side; a second locking part is arranged on the inner ring of the second locking ring and opposite to the second locking ring elastic piece, the second locking part is abutted against the threaded rod under the action of the second locking ring elastic piece to realize locking, a second key is pressed to drive the second locking ring to move, and the second locking part is separated from the threaded rod to realize unlocking.
Further, the second locking part is a threaded part matched with the threaded rod, and the threaded part is matched with the threaded rod to realize locking. Of course, in other embodiments, the second locking portion may also be a protrusion that is engaged in the threaded portion of the threaded rod, and the like, and is not limited herein and may be adjusted according to specific situations.
Of course, the implementation of the second locking device 9 in other embodiments is not limited to the above, and can be adjusted according to specific situations; in some embodiments, when the second fine tuning assembly has a self-locking function, the second locking device 9 can be omitted, and is not limited herein and can be adjusted according to specific situations.
In this embodiment, with reference to fig. 4 and 8, the connecting assembly comprises a first hook structure 501 provided on the first handle 1 and a second hook structure 502 provided on the second handle 2, and an unlocking structure provided on the first handle 1 or the second handle 2; the first handle 1 and the second handle 2 are coaxially butted, and the first hook-shaped structure 501 and the second hook-shaped structure 502 are buckled together to realize locking connection; the unlocking structure is slid backwards, and the unlocking structure pushes the first hook structure 501 or the second hook structure 502, so that the first hook structure 501 is separated from the second hook structure 502 to realize unlocking.
Further, as shown in fig. 8, the unlocking structure includes a slider 503, a first slope structure 504, and a second slope structure 505; the side wall of the second handle 2 is provided with a sliding groove 202, the sliding block 503 is arranged in the sliding groove 202 and can move along the sliding groove 202, and the moving direction is parallel to the axial direction of the inner push rod 4 and the outer sheath tube 3; the first slope structure 504 is located in the second handle 2 and connected with the sliding block 503 through a connecting part; a second hook structure 502 is displaced below the runner 202, and a second ramp structure 505 is disposed on the second hook structure 502 opposite the first ramp structure 504; after the first hook structure 501 and the second hook structure 502 are connected together, the first inclined plane structure 504 is abutted against the second inclined plane structure 505; the sliding block 503, the first inclined surface structure 504 slides along the second inclined surface structure 505, and pushes the second hook-shaped structure 502 to move along the second handle 2 in the radial direction, so that the second hook-shaped structure 502 is separated from the second hook-shaped structure, and the unlocking is realized.
Further, a sliding block elastic piece 506 is arranged between the sliding block 503 and the sliding groove 202, when the sliding block 503 moves along the sliding groove 202 for unlocking, the sliding block elastic piece 506 deforms for energy storage, and after unlocking is completed, the sliding block resets under the action of the sliding block elastic piece 506. The slider elastic member 506 may be implemented by a spring, and the like, which is not limited herein.
The coupling assembling that this embodiment provided adopts the form of elasticity buckle to realize, and it has advantages such as simple structure, convenient operation, and other connection structure also can select for use in other embodiments of course, do not do the restriction here.
In the present embodiment, referring to fig. 9-10, the implant loading device 11 includes a loading catheter 1101 disposed on the distal end of the inner pushing rod 4, the loading catheter 1101 is mounted on the distal end of the inner pushing rod 4 through a loading catheter holder 1103, the inner pushing rod 4 is axially movable relative to the loading catheter 1101 and the loading catheter holder 1103, and the distal end of the inner pushing rod 4 is axially movably inserted into the loading catheter 1101; the distal end of the inner push rod 4 is further provided with a fastener 1102 for fixing an implant.
Wherein, the fixing member 1102 is provided with a groove structure 1104 for fixing the implant 14, as shown in fig. 10, the implant is sleeved on the end of the fixing member 1102 and is partially arranged in the groove structure 1104; of course, the specific structure of the fixing member 1102 is not limited to the above, and may be adjusted according to the structure of the implant, and is not limited thereto.
The material of the fixing member 1102 may be a metal or a polymer material with suitable hardness and good biocompatibility, such as stainless steel, which is not limited herein and can be adjusted according to specific situations.
The following description will be made specifically for the case where the present invention is applied to the delivery of a heart shunt device; therein, as shown in fig. 11-12, the cardiac shunt device is divided into a first region 1401, a second region 1402, and a third region 1403. The cardiac shunt 14 can be implanted by: a puncture is made through the interatrial septum and then a cardiac shunt device 14 is inserted percutaneously therethrough such that the first region 1401 extends into the left atrium of the patient, the second region 1402 is embedded in the puncture, and the third region 1403 extends into the right atrium of the patient, preferably the third region 1403 extends at least 5mm into the right atrium of the patient such that the exit of the third region 1403 is located outside the natural circulatory flow path of blood from the inferior vena cava into the right atrium of the patient, which prevents emboli entrained in the inferior vena cava flow from being directed into the exit of the third region 1403.
The release of the implant 14 is divided into the release of the left atrial stent and the release of the right atrial stent. The specific operation is as follows:
1. the implant 14 is loaded and pressed into the loading catheter 1101, specifically, the implant 14 is matched and connected with the groove structure 1104 on the fixing piece 1102 through the ear structure on the implant 14, and then the implant is pressed into the loading catheter 1101;
2. pushing the loading catheter 1101 with the implant into the sheath 3, then pushing the inner push rod 4, pushing the implant 14 from the loading catheter into the sheath 3 through the fastener 1102, the loading catheter 1101 staying at the proximal end of the sheath 3;
3. and continuing to push the second handle 2, pushing the implant 14 by the inner push rod 4 to advance along the inner wall of the outer sheath 3 until the first handle 1 and the second handle 2 are combined and locked by the connecting component and fixed with each other to form a complete handle. After combination, the implant 14 is at a distance of 3-5mm from the distal end of the exposed sheath 3 (the distance tolerance is compensated for by assembly errors);
4. the key of the second locking device 9 is pressed down and kept in a pressed-down state, and then the threaded knob on the second handle 2 is rotated to push the inner push rod 4 to continue to advance towards the far end; the left atrial part of the implant 14 is slowly released from the head end of the outer sheath 3, when released to the waist (region 1402) of the implant 14, the operation of the screw knob is stopped, the second locking means 9 is released, so that the inner push rod 4 is restored to be fixed relative to the second handle 2;
5. after the left atrial portion is completely released, the delivery system is entirely withdrawn, so that the delivery system and the implant 14 are entirely withdrawn until the waist of the implant 14 is just caught on the atrial septum;
6. pressing down the key 804 of the first locking device 8 to keep the pressed state, rotating the threaded knob on the first handle to withdraw the outer sheath 3, slowly releasing the right atrium portion (region 1403) of the implant 14 until the hangers are completely exposed, disengaging the implant 14 from the fixing piece to realize complete release, and then loosening the first locking device 8;
7. after release, the delivery system is withdrawn from the body by total withdrawal.
It will be appreciated by those skilled in the art that the invention can be embodied in many other specific forms without departing from the spirit or scope thereof. Although embodiments of the present invention have been described, it is to be understood that the present invention should not be limited to those precise embodiments, and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined by the appended claims.
Claims (11)
1. An implant delivery system comprising a first handle to which an outer sheath is connected, a second handle to which an inner pusher is connected, and an implant loading device disposed on a distal end of the inner pusher remote from the second handle, wherein the outer sheath is axially adjustably moveable relative to the first handle and the inner pusher is axially adjustably moveable relative to the second handle; and a connecting assembly is further arranged between the first handle and the second handle, and when the first handle and the second handle are connected through the connecting assembly, the inner push rod penetrates through the outer sheath.
2. The implant delivery system of claim 1, wherein the proximal end of the outer sheath and the proximal end of the inner pusher are axially adjustably mounted to the first handle portion and the second handle portion, respectively, by a fine adjustment assembly. Preferably, the fine adjustment assembly comprises:
one end of the adjusting rod is axially movably arranged in the first handle/the second handle, and the other end of the adjusting rod is provided with an adjusting part; the near end of the outer sheath tube/the inner push rod is coaxially connected with the adjusting rod;
and the adjusting piece is arranged on the first handle/the second handle, is connected with the adjusting part in a matching way, and drives the adjusting piece to drive the adjusting rod to move axially.
3. The implant delivery system according to claim 2, wherein the adjustment portion is a threaded rod, the adjustment member is a threaded knob, the threaded knob is disposed on the threaded rod and threadedly engaged with the threaded rod, and the threaded knob is axially and circumferentially rotatably mounted on the first/second handles.
4. The implant delivery system according to claim 2, wherein the adjustment rod is provided with at least one guide protrusion, the guide groove is parallel to the axial direction of the adjustment rod, and the first/second handles are provided with a guide groove at the corresponding position, and the guide protrusion is disposed in the guide groove and can move along the guide groove.
5. The implant delivery system according to claim 2 or 3, wherein a locking device is provided between the first handle, the second handle and the adjustment rod for limiting axial movement of the adjustment rod relative to the first handle and the second handle.
6. The implant delivery system according to claim 5, wherein the locking device comprises a locking ring, the locking ring is sleeved on one circle of the adjusting rod, a locking ring elastic member is arranged between one side of the locking ring and the inner wall of the first handle/the second handle, and a key extending out of the first handle/the second handle is arranged on the opposite side;
the locking part is arranged on the inner ring of the locking ring and opposite to the elastic piece, the locking part is abutted against the adjusting rod under the action of the elastic piece of the locking ring to realize locking, the key is pressed to drive the locking ring to move, and the locking part is separated from the adjusting rod to realize unlocking.
7. The implant delivery system of claim 6, wherein when the adjustment portion on the adjustment rod is a threaded rod, the locking portion is a threaded portion that mates with the threaded rod, and the threaded portion mates with the threaded rod to effect locking.
8. The implant delivery system of claim 1, wherein the coupling assembly includes a first hook structure disposed on the first handle and a second hook structure disposed on the second handle, and an unlocking structure disposed on the first handle or the second handle;
the first handle is coaxially butted with the second handle, and the first hook-shaped structure and the second hook-shaped structure are buckled together to realize fixation; and when the unlocking structure is pressed, the unlocking structure pushes the first hook structure or the second hook structure, so that the first hook structure is separated from the second hook structure to realize unlocking.
9. The implant delivery system of claim 8, wherein the unlocking structure comprises:
the shell of the second handle is provided with a sliding groove, and the sliding block is arranged in the sliding groove;
the first inclined surface structure is positioned in the second handle and is connected with the sliding block;
a second ramp structure disposed on the second hook structure;
after the first hook-shaped structure and the second hook-shaped structure are connected together, the first inclined plane structure is abutted against the second inclined plane structure; and sliding the sliding block, wherein the first inclined surface structure slides along the second inclined surface structure, and the second hook-shaped structure is pushed to move along the radial direction of the second handle to be separated from the second hook-shaped structure.
10. The implant delivery system according to claim 9, wherein a slider elastic member is disposed between the slider and the sliding groove, when the slider moves along the sliding groove for unlocking, the slider elastic member deforms for storing energy, and after unlocking is completed, the slider is reset under the action of the slider elastic member.
11. The implant delivery system according to claim 1, wherein the implant loading device includes a loading catheter disposed on the distal end of the inner push rod, and the distal end of the inner push rod is axially movably disposed through the loading catheter; the distal end of the inner push rod is further provided with a fixing piece for fixing an implant, and preferably, the proximal end of the inner push rod, which is close to the second handle, is further provided with a reinforcing tube.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011642708.9A CN112603599A (en) | 2020-12-30 | 2020-12-30 | Implant delivery system |
| EP21912993.9A EP4272700A1 (en) | 2020-12-30 | 2021-07-02 | Implant delivery system |
| PCT/CN2021/104351 WO2022142239A1 (en) | 2020-12-30 | 2021-07-02 | Implant delivery system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011642708.9A CN112603599A (en) | 2020-12-30 | 2020-12-30 | Implant delivery system |
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| Publication Number | Publication Date |
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| CN112603599A true CN112603599A (en) | 2021-04-06 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202011642708.9A Pending CN112603599A (en) | 2020-12-30 | 2020-12-30 | Implant delivery system |
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| CN (1) | CN112603599A (en) |
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