CN113796988A - Valve conveying system capable of adjusting positioning - Google Patents
Valve conveying system capable of adjusting positioning Download PDFInfo
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- CN113796988A CN113796988A CN202011087181.8A CN202011087181A CN113796988A CN 113796988 A CN113796988 A CN 113796988A CN 202011087181 A CN202011087181 A CN 202011087181A CN 113796988 A CN113796988 A CN 113796988A
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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
- A61F2/2427—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
- A61F2/02—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
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/2439—Expansion controlled by filaments
Abstract
The application relates to an adjustable positioning valve delivery system, which comprises a valve prosthesis, a control handle, an inner tube and a rotating part, wherein an adjusting mechanism and a control release device are connected between the inner tube and an outer sheath, the rotating part is connected with the adjusting mechanism in a matching way, one end of the valve prosthesis is connected with one end of the adjusting mechanism in a matching way, the control release device is sleeved on the other end part of the valve prosthesis and limits the radial expansion of the other end part of the valve prosthesis, the rotating part is operated and drives the adjusting mechanism to rotate, the adjusting mechanism drives the valve prosthesis to rotate, and in the process, the control release device rotates along with the valve prosthesis and keeps relative static with the valve prosthesis; the invention solves the problems that the position of the valve prosthesis can not be adjusted after the positioning part of the existing valve prosthesis is released, so that the positioning part of the valve prosthesis is not accurate enough to be positioned in the sinus, and the stent flies when the valve prosthesis is released in the heart without limitation.
Description
Technical Field
The invention belongs to the field of medical equipment, and particularly relates to an adjustable positioning valve delivery system.
Background
Aortic Stenosis (AS) is one of the common valvular diseases, with a 4.6% incidence rate in people over 75 years of age in the united states, and the third most common cardiovascular disease in the united states following coronary heart disease and hypertension. Surgical aortic valve replacement has long been the only accepted treatment for long term efficacy. Nevertheless, based on high risk assessment of surgery and concern for postoperative complications, there are 1/3-2/3 patients who abandon surgical treatment and therefore have an average annual mortality rate of 50-60% once symptomatic. Due to continuous innovation of heart intervention means and medical instruments, medical catheter treatment, especially Percutaneous Aortic Valve Replacement (PAVR) gradually becomes a mainstream operation mode, and clinical tests prove that the medical catheter treatment is simple, convenient and feasible, and brings good news to patients who cannot receive surgical treatment.
The main options for percutaneous aortic valve replacement currently available are three surgical approaches, namely the anterior (transfemoral and interatrial puncture), the reverse (retrograde entry into the aortic arch via the femoral artery) and the non-extracorporeal direct access valve replacement (transapical), the second of which is the most convenient and rapid technique and is widely used. The existing stent delivery systems in the market are represented by an Edwards balloon-expanded SAPIEN valve stent delivery system and a Corevalveve self-expanding ReValling valve stent delivery system, and research and development personnel continuously provide technical schemes and instrument innovations so as to improve the survival rate of patients and the living condition of the patients.
Nevertheless, PAVR still faces technical difficulties such as target population selection, long-term efficacy and complications. Research shows that improvement of a valve stent delivery system and an operation technology plays a crucial role in inhibiting complications such as aortic perforation, paravalvular leakage, thrombus, cerebral apoplexy and the like. For example, in patent cn201110092241.x, edward life sciences provides a heart valve delivery system (10) in which a prosthetic valve (16) is mounted on a valve catheter (23) inside a delivery sleeve (24). A step balloon (18) extends from the delivery cannula and provides a tapered surface for facilitating advancement through a body vessel. The stage balloon also facilitates passage through the leaflets of the native valve. After the prosthetic valve is positioned within the native valve, the delivery sleeve is retracted to expose the prosthetic valve. In one embodiment, the delivery sleeve is retracted by use of a lead screw (500) that effects relative movement between the valve catheter and the delivery sleeve. The prosthetic valve is preferably self-expanding. If desired, the stage balloon can be expanded to securely seat the prosthetic valve at the native valve site. The prosthetic valve is preferably connected to the valve catheter by a plurality of flexible extension arms (80) which enable the prosthetic valve to be collapsed after initial deployment of the prosthetic valve so that the prosthetic valve can be repositioned if desired; the technical scheme has the defects that: when the artificial valve is released to be positioned in the heart, the circumferential position of the artificial valve needs to be adjusted, so that the positioning of the artificial valve can be more accurate, and the design scheme does not design a structure which can enable the artificial valve to be adjusted in the circumferential position, so that the valve cannot be adjusted in the positioning position, the artificial valve is positioned in the heart by one step, the fault tolerance rate is very low, and the risk coefficient of the operation is greatly improved.
Therefore, the aortic valve replacement operation performed at present does not have a structure which can enable the valve prosthesis to be adjusted in the circumferential position after the positioning piece is released in the heart, so that the positioning piece can enter the sinus more accurately during positioning, and the operation risk is reduced. Therefore, a stent delivery system that is simpler to operate, more accurate in positioning, less in surgical complications and shorter in surgical time is urgently desired by both medical personnel and patients.
Disclosure of Invention
It is an object of the present invention to overcome the deficiencies of the prior art and to provide an adjustably positionable valve delivery system for patients with aortic stenosis and requiring interventional procedures. The invention solves the problems that the position of the valve prosthesis can not be adjusted after the positioning part of the existing valve prosthesis is released, so that the positioning part/positioning part is not accurately positioned in the sinus, and the bracket flies when the valve prosthesis is released in the heart without limitation.
The purpose of the invention is realized by the following scheme:
the utility model provides an adjustable location's valve delivery system, includes valve prosthesis, brake valve lever, the inner tube of being connected with brake valve lever cooperation, sets up the rotating member on brake valve lever, still the cooperation is connected with guiding mechanism and control release between inner tube and the sheath, the rotating member is connected with guiding mechanism cooperation, the one end of valve prosthesis with guiding mechanism's one end cooperation is connected, control release device cover is established on another tip part of valve prosthesis and restriction the radial expansion of another tip part of valve prosthesis, the operation the rotating member drives guiding mechanism is rotatory, guiding mechanism drives the valve prosthesis is rotatory, at this in-process, control release follows the valve prosthesis is rotatory together and with the valve prosthesis keeps relative stillness.
The purpose of the invention can be further realized by the following technical scheme:
in one embodiment, the control handle is provided with a control release member, an adjusting mechanism moving member and a locking switching device, the control release member controls the axial movement of the control release member, the adjusting mechanism moving member can control the axial movement of the adjusting mechanism, the locking switching device can be operated to enable the control release member and the adjusting mechanism moving member to be in a locking state or a separation state, and when the control release member and the adjusting mechanism moving member are in the locking state, the inner tube and the adjusting mechanism can synchronously move axially.
In one embodiment, when the valve prosthesis needs to be axially adjusted, the locking and switching device is operated to enable the valve delivery system to be in a locked state, and the inner tube and the adjusting mechanism can synchronously and axially move under the condition that the outer sheath is not moved by continuously operating the control release part or the adjusting mechanism moving part, so that the axial position of the valve prosthesis is adjusted.
In one embodiment, when the locking and switching device is operated to separate the valve delivery system after the valve prosthesis is positioned/implanted in the desired position, the control release member is operated to release the other end portion of the valve prosthesis.
In one embodiment, the adjustment mechanism includes a transmission member cooperatively connected to the control handle, and a coupling member cooperatively connected to a distal end of the transmission member, the coupling member cooperatively connected to a proximal end of the valve prosthesis.
In one embodiment, the connecting piece comprises a base fixedly connected to the far end of the transmission piece, and a plurality of connecting claws uniformly distributed on the base, wherein hole-shaped structures are arranged on the connecting claws; a proximal portion of the valve prosthesis passes through the aperture-like structure.
In one embodiment, the transmission member is a rod member.
In a preferred embodiment, the transmission member is made of a medical grade stainless steel material.
In a preferred embodiment, the valve delivery system further comprises a stop member disposed on the inner tube, the stop member being connected to the other end of the valve prosthesis when the implantation instrument is loaded with the delivery system, the stop member being capable of cushioning-releasing the other end of the valve prosthesis and gradually disengaging from the control-releasing device during distal movement of the control-releasing device by operating the control handle.
In one embodiment, a rotating structure is disposed between the inner tube and the control release device, and when the control handle is operated to make the adjusting mechanism drive the valve prosthesis to rotate and further drive the control release device to rotate, the inner tube and the outer sheath tube are both kept stationary.
In one embodiment, the rotational structure includes a protrusion disposed on the inner tube and a groove disposed within the controlled release device, the protrusion being disposed within the groove.
In a preferred embodiment, the rotating structure may be a bearing, the end portion of the distal end of the inner tube is sleeved in the bearing, and an outer ring of the bearing is fixed to the control release device, so that when the control handle is operated, the adjusting mechanism drives the valve prosthesis to rotate and further drives the control release device to rotate, the inner tube and the outer sheath tube are both kept stationary.
In one embodiment, the controlled release device is a wire-like member or the controlled release device is a withdrawal sheath.
In a preferred embodiment, the controlled release device is a withdrawal sheath; when the positioning part on the valve prosthesis is released, the distal part of the valve prosthesis is limited in the withdrawing sheath, the rotating part is controlled to drive the adjusting mechanism and the adjusting mechanism to drive the valve prosthesis to rotate, and the valve prosthesis and the control releasing device synchronously rotate along with the adjusting mechanism.
In another preferred embodiment, the control release device is a linear member, the control release device may be a thread or a wire, one end of the control release device is connected with the control handle in a matching manner, the other end of the control release device is detachably connected with the distal end portion of the valve prosthesis, when the positioning element on the valve prosthesis is released, the rotating element is operated to drive the adjusting mechanism and the adjusting mechanism to drive the valve prosthesis to rotate, and the valve prosthesis and the control release device rotate synchronously along with the adjusting mechanism.
In one embodiment, a hollow lumen is further disposed between the inner tubing and the outer sheath, and the adjustment mechanism proximal portion is disposed within the hollow lumen.
In a preferred embodiment, an adjusting bending pipe is further arranged between the cavity pipe and the outer sheath, the control handle is provided with an adjusting bending knob for controlling the adjusting bending pipe to realize angle adjustment, the adjusting bending pipe comprises an adjusting bending inner pipe and an adjusting bending outer pipe, the distal end of the adjusting bending inner pipe and the distal end of the adjusting bending outer pipe are both provided with a cutting slit, and the cutting slits of the adjusting bending inner pipe and the adjusting bending outer pipe are arranged oppositely.
In one embodiment, a plurality of channels are disposed within the hollow tube, the adjustment mechanism is disposed within one channel, and the control release is disposed within another channel; the design has the advantages that: effectively distinguish two device structures and do not generate interference between the two device structures.
In one embodiment, a plurality of control wires are further arranged in the cavity tube.
In a preferred embodiment, the control wire is made of nitinol wire with a diameter of 0.2mm to 0.5 mm.
In one embodiment, a stopper is disposed on the proximal end of the valvular prosthesis, the stopper protrudes from the hole-like structure, and the control wire penetrates through the stopper, so that the proximal end of the valvular prosthesis is detachably connected to the control wire.
In one embodiment, the control handle is provided with a spinning knob capable of operating the control wire and a control release button capable of operating the control release device.
Compared with the prior art, the invention has the advantages that:
1. different from the prior art, the invention is provided with the adjusting mechanism and the controlled release device, when the positioning part on the valve prosthesis is released, the outer sheath is kept still, the distal part of the valve prosthesis is limited to be released by the controlled release device and is kept relatively still with the controlled release device, the adjusting mechanism is matched and connected with the proximal end of the valve prosthesis and drives the valve prosthesis to carry out circumferential position adjustment so that the positioning part on the valve prosthesis can be positioned/implanted to an ideal position, and then the distal part of the valve prosthesis is released, so that the valve prosthesis can be accurately positioned at a target position; meanwhile, the valve conveying system can also utilize the locking and switching device to perform movement adjustment on the axial position of the valve prosthesis on the premise that the bending angle is fixed, and in the process of axial adjustment, the central axis position of the valve prosthesis and the central axis position of the autologous valve are always in an aligned state and do not deviate, and if the control handle is directly pushed/jacked, the central axis of the valve prosthesis and the central axis of the autologous valve are not overlapped/not parallel, and an included angle is formed between the central axis of the valve prosthesis and the central axis of the autologous valve, so that the valve prosthesis cannot reach a correct release position;
2. the adjusting mechanism can adjust the angle of the valve prosthesis in the circumferential position (the positioning part can be accurately positioned in an ideal position) when the valve prosthesis is partially released, and can also adjust the valve prosthesis in the axial position by using the locking and switching device, so that the positioning and the releasing of the valve prosthesis are more accurate, other structures are not needed to be newly added for adjustment and control, the valve prosthesis is very convenient to operate and control, and the structure is simplified;
3. in the prior art, the scheme of adjusting/rotating the valve prosthesis is achieved by directly rotating the control handle, and because the outer sheath and the vascular wall have friction and the distance of the blood vessel in a human body is far and meanders, the adjustment of the control handle and the valve prosthesis at the far end is difficult to achieve accurate transmission all the time, and when the valve prosthesis needs a specific circumferential position, accurate adjustment and control cannot be achieved; meanwhile, one surface with sparse grids can be aligned to the coronary ostia, so that the coronary blockage is avoided; or the valve prosthesis with the positioning piece is precisely introduced into the sinus;
4. the valve prosthesis release device is provided with the control wire and the control release device which respectively realize the controllable release of the proximal end and the distal end of the valve prosthesis, so that the whole valve prosthesis can be released in a limited way after the positioning part is released, and the positioning part can be better found or adjusted to an ideal sinus entering position;
5. the control wire penetrates through the limiting piece, so that the proximal end of the valve prosthesis is detachably connected with the control wire, the proximal end of the valve prosthesis is controllably released, and the proximal end of the valve prosthesis is prevented from rebounding to stab surrounding heart tissues after the outer sheath is released;
6. because the path of a blood vessel in a human body is far and the path is tortuous, one end of the inner tube is connected with the control release part and controls the axial movement of the inner tube, if the valve prosthesis rotates along with the valve prosthesis in the process of rotating adjustment, the resistance of the rotating adjustment of the control handle can be greatly increased, and then the inner tube not only pushes the control release device to enable the far end of the valve prosthesis to be released, but also rotates along with the valve prosthesis, so that the structural design of the control handle of the conveying system is quite complex, and the inner tube needs to be kept still when the valve prosthesis rotates; because friction force exists between the valve prosthesis and the control release device when the valve prosthesis rotates, if the control release device is kept still, the friction force between the valve prosthesis and the control release device when the valve prosthesis rotates can damage the valve prosthesis, so when the valve prosthesis rotates, the control release device rotates along with the valve prosthesis; based on this, when the valve prosthesis rotates, the control release device rotates, and the inner tube needs to be kept still, so the rotating structure is arranged between the far end of the inner tube and the control release device, the inner tube and the control release device keep relative rotation, and the problems are ingeniously solved.
Drawings
Fig. 1a to 1c are schematic structural views of the present invention, wherein fig. 1a is a schematic overall structural view, fig. 1b is a partially enlarged view of fig. 1a, and fig. 1c is a schematic structural view of a connecting member.
Fig. 2a-2h are schematic views of the delivery system of the present invention manipulating circumferential adjustment of a valvular prosthesis within the heart.
Fig. 3a to 3c are schematic views of various embodiments of the rotating structure of the present invention.
Fig. 4 is a schematic structural diagram of another embodiment of the controlled release device of the present invention.
Fig. 5 a-5 c are schematic views illustrating the process of the delivery system of the present invention for manipulating the valve prosthesis to perform axial adjustment in the heart, wherein fig. 5c is a schematic view illustrating the prior art for directly pushing/ejecting the control handle to achieve axial adjustment of the valve prosthesis.
Fig. 6a to 6c are schematic structural views of the control handle of the present invention.
The specific implementation mode is as follows:
in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.
The far end of the invention refers to the end far away from the operator, and the near end refers to the end close to the operator.
The first embodiment is as follows:
in one embodiment, as shown in fig. 1a, for example, to treat aortic valvular disease, an adjustable positioning valve delivery system includes a valvular prosthesis 1, a control handle 2, an inner tube 3 connected to the control handle 2, and an outer sheath 4, an adjusting mechanism 5 and a control release device 6 are further connected between the inner tube 3 and the outer sheath 4, the control handle 2 is connected to the adjusting mechanism 5, one end of the valvular prosthesis 1 is connected to one end of the adjusting mechanism 5, the control release device 6 is sleeved on the other end of the valvular prosthesis 1 and limits the other end of the valvular prosthesis 1 from expanding radially, the control handle 2 is operated and the adjusting mechanism 5 is driven to rotate, the adjusting mechanism 5 drives the valvular prosthesis 1 to rotate, during which, the outer sheath 4 remains stationary, and the control release device 6 rotates with the valvular prosthesis 1 and remains with the valvular prosthesis 1 Relatively static; after the positioning element 11 on the valve prosthesis 1 is released, the outer sheath 4 remains motionless, the distal end portion of the valve prosthesis 1 is limited to be released by the control release device 6 and remains relatively static with the control release device 6, the adjusting mechanism 5 is connected with the proximal end of the valve prosthesis 1 in a matching manner and drives the valve prosthesis 1 to perform circumferential position adjustment so that the positioning element 11 on the valve prosthesis 1 can be positioned/implanted to an ideal position, and then the distal end portion of the valve prosthesis 1 is released so that the valve prosthesis 1 can be accurately positioned at a target position, and when the position is adjusted, because the outer sheath 4 remains motionless all the time, damage to a blood vessel wall can be avoided, and a protection effect is achieved.
In one embodiment, the control handle 2 is provided with a control release member 23 (for controlling the inner tube to move axially), a rotating member 21 (for controlling the adjustment mechanism 5 to rotate), an adjustment mechanism moving member 25, a wire drawing knob 22, and a locking switching device 24, as shown in fig. 6a and 6b, the rotating member 21 can control the adjustment mechanism 5 to rotate (the control rotation can be connected by a knob and a screw), the wire drawing knob 22 can operate the control wire 8, and the control release member 23 can control the control release device 6; the locking switching device 24 can switch the inner tube 3 and the adjusting mechanism 5 back and forth between a locking state and a separation state (as shown in fig. 6 c); when the locking and switching device 24 is operated to separate the inner tube 3 from the adjusting mechanism 5, the control release member 23 is operated to axially move the inner tube 3 relative to the adjusting mechanism 5, so that the other end portion of the valvular prosthesis 1 is released; the controlled release device 6 may employ a withdrawal sheath 62 and, similarly, a wire-like member 61 (shown in fig. 4).
In one embodiment, as shown in fig. 1b, the adjusting mechanism 5 comprises a transmission member 51 cooperatively connected with the control handle 2, and a connecting member 52 cooperatively connected with the distal end of the transmission member 51, wherein the connecting member 52 is cooperatively connected with the proximal end of the valvular prosthesis 1.
In one embodiment, the valve delivery system further comprises a stop member 12, the stop member 12 is sleeved on the inner tube 3, and when the implantation instrument and the delivery system are loaded, the stop member 12 is connected with the distal end of the valve prosthesis 1.
In another embodiment, as shown in fig. 1c, the connecting element 52 includes a base 521 fixedly connected to the distal end of the transmission element 51, and a plurality of connecting claws 522 uniformly distributed on the base 521, wherein the connecting claws 522 are provided with hole-shaped structures 523; the proximal part of the valve prosthesis 1 passes through the porous structure 523; after the positioning element 11 on the valvular prosthesis 1 is released, the proximal end portion of the valvular prosthesis 1 is still in fit connection with the hole-shaped structure 523, and the control handle 2 is operated, so that the transmission member 51 drives the connecting member 52 and the connecting member 52 to drive the valvular prosthesis 1 to perform adjustment in the circumferential direction, and in the adjustment process, the control release device 6 and the distal end portion of the valvular prosthesis 1 are always kept relatively stationary.
In one embodiment, the transmission member 51 is a rod member; the transmission member 51 is made of medical stainless steel.
In one embodiment, as shown in fig. 3a and 3b, a rotating structure 10 is arranged between the inner tube 3 and the control release device 6, so that the inner tube 3 and the control release device 6 always keep relative rotation, the rotating structure comprises a protrusion 101 arranged on the inner tube 3 and a groove 102 arranged in the control release device 6, the protrusion is arranged in the groove 102, when the adjustment mechanism 5 drives the valvular prosthesis 1 to rotate, the valvular prosthesis 1 drives the control release device 6 to rotate due to friction between the valvular prosthesis 1 and the control release device 6; meanwhile, the inner tube 3 is kept still, so that the valve prosthesis 1 has smaller resistance in the rotation adjustment process and is convenient to adjust.
In another embodiment, as shown in fig. 3c, the rotating structure 10 may be a bearing 103, the distal end of the inner tube 3 is sleeved in the bearing 103, and the outer ring of the bearing 103 is fixed to the release control device 6, so that the inner tube 3 and the release control device 6 always maintain relative rotation.
In another embodiment, a hollow tube 7 is further disposed between the inner tube 3 and the outer sheath 4, and the proximal end portion of the adjustment mechanism 5 and the proximal end portion of the control release device 6 are disposed within the hollow tube 7; the cavity pipe 7 is made of high polymer materials.
In a preferred embodiment, an adjusting pipe 9 is further disposed between the cavity tube 7 and the outer sheath 4, and the adjusting pipe 9 includes an adjusting inner pipe 91 and an adjusting outer pipe 92.
In one embodiment, a plurality of channels are provided within the hollow tube 7, the adjustment mechanism 5 is provided in one channel, and the control release 6 is provided in another channel; the design has the advantages that: effectively distinguish two device structures and do not generate interference between the two device structures.
In one embodiment, a plurality of control wires 8 are also arranged in the cavity tube 7.
In a preferred embodiment, the control wire 8 is made of nitinol wire with a diameter of 0.2mm to 0.5 mm.
In one embodiment, as shown in fig. 2b, a stopper 12 is disposed on the proximal end of the valvular prosthesis 1, the stopper 12 protrudes from the hole-like structure 523, and the control wire 8 passes through the stopper 12, so that the proximal end of the valvular prosthesis 1 is detachably connected to the control wire 8; when the positioning part 11 of the valve prosthesis 1 is released, the proximal end and the distal end of the valve prosthesis 1 are respectively limited and released by the control wire 8 and the control release device 6, so that the valve prosthesis 1 is still in a compressed state, and the adjustment mechanism 5 is operated to adjust the circumferential/axial position of the whole valve prosthesis 1 (including the positioning part 11), so that the delivery system can be positioned when the valve prosthesis 1 only releases the positioning part 11 and the whole valve prosthesis 1 is still in the compressed state, and the valve prosthesis 1 can be adjusted in time in the positioning process.
The working principle of the invention is as follows:
as shown in fig. 2a-2h, the conveying system comprises a control handle 2, the control handle 2 is provided with a rotating member 21, a wire drawing knob 22 and a control releasing member 23, which respectively control the adjusting mechanism 5, the control wire 8 and the control releasing device 6; the control handle 2 is also provided with a locking switching device 24, and the locking switching device 24 can control the inner tube 3 and the adjusting mechanism 5 to switch back and forth between a locking state and a separation state; the distal end of the control handle 2 is connected with an inner tube 3 in a matching way and an outer sheath 4 connected to the periphery of the inner tube 3 in a matching way, an adjusting mechanism 5 and a control releasing device 6 are further connected between the inner tube 3 and the outer sheath 4 in a matching way, the valve prosthesis 1 with a positioning piece 11 is installed in a conveying system, the proximal end of the valve prosthesis 1 is connected with the distal end of the adjusting mechanism 5 in a matching way, the distal end part of the valve prosthesis 1 is connected with the control releasing device 6 in a matching way, more specifically, the distal end part of the valve prosthesis 1 is arranged in the control releasing device 6, a limiting piece 12 at the proximal end of the valve prosthesis 1 penetrates through a hole-shaped structure 523 on the adjusting mechanism 5, and a control wire 8 penetrates through the limiting piece 12, so that the proximal end of the valve prosthesis 1 is detachably connected with the control wire 8; after the delivery system enters the heart, the outer sheath 4 is released firstly, when the outer sheath 4 is withdrawn to the proximal part of the valve prosthesis 1, the positioning piece 11 on the valve prosthesis 1 is released, at the moment, the rotating piece 21 is operated to drive the transmission piece 51 to rotate, the transmission piece 51 drives the connecting piece 52 to rotate, and the connecting piece 52 drives the valve prosthesis 1 to rotate, meanwhile, the release control device 6 and the valve prosthesis 1 are kept relatively static, so that the adjusting mechanism 5 can drive the whole valve prosthesis 1 to rotate when rotating, and the positioning piece 11 can be positioned to an ideal position conveniently; after the positioning member 11 is positioned at the desired position, when the locking and switching device 24 is operated to separate the inner tube 3 from the adjusting mechanism 5, the control release member 23 is operated to release the other end portion of the valvular prosthesis 1, the control release device 6 is separated from the distal end of the valvular prosthesis 1, and then the control wire 8 is withdrawn from the retaining member 12 by operating the wire-drawing knob 22, so that the proximal end of the valvular prosthesis 1 is also released, and finally the implantation is completed (as shown in fig. 2 h).
The second embodiment is as follows:
in another embodiment, as shown in fig. 5a and 5b, for example, to treat aortic valvular disease, an adjustable positioning valve delivery system includes a valvular prosthesis 1 having a positioning member 11, a control handle 2, an inner tube 3 cooperatively connected with the control handle 2, an outer sheath 4, and a rotating member 21 disposed on the control handle 2, an adjusting mechanism 5 and a control releasing device 6 are further cooperatively connected between the inner tube 3 and the outer sheath 4, the rotating member 21 is cooperatively connected with the adjusting mechanism 5, one end of the valvular prosthesis 1 is cooperatively connected with one end of the adjusting mechanism 5, the control releasing device 6 is sleeved on the other end portion of the valvular prosthesis 1 and limits radial expansion of the other end portion of the valvular prosthesis 1, the rotating member 21 is operated and drives the adjusting mechanism 5 to rotate, the adjusting mechanism 5 drives the valvular prosthesis 1 to rotate, in the process, the control release device 6 rotates along with the valve prosthesis 1 and keeps relatively static with the valve prosthesis 1; the adjusting mechanism 5 can adjust the angle of the valve prosthesis 1 in the circumferential position (the positioning piece 11 can be accurately positioned in an ideal position) when the positioning piece 11 is released from the valve prosthesis 1 but the whole valve prosthesis 1 is not released, and can also adjust the valve prosthesis 1 in the axial position by using the locking and switching device 24 on the premise of fixing the bending angle, and the outer sheath 4 can be kept still all the time, so that the conditions that plaque falls off, stroke occurs and the vascular wall is laminated due to the fact that the outer sheath 4 can scrape the vascular wall in the adjusting process can be avoided, and meanwhile, in the axial adjusting process, the central axis position of the valve prosthesis 1 and the central axis position of the autologous valve are always aligned, and deviation does not occur; if the control handle 2 is pushed/jacked directly, as shown in fig. 5c, the central axis of the valvular prosthesis 1 is not coincident/parallel with the central axis of the native valve and the central axis of the valvular prosthesis 1 is included with the central axis of the native valve, so that the valvular prosthesis 1 cannot reach the correct release position.
In one embodiment, the control handle is provided with a control release member 23, a rotating member 21, an adjusting mechanism moving member 25 and a locking switching device 24, the rotating member 21 can control the adjusting mechanism 5 to rotate (the connection mode of the control rotation can adopt a connection mode of a knob and a screw), the control release member 23 controls the axial movement of the inner tube 3, the adjusting mechanism moving member 25 can control the axial movement of the adjusting mechanism 5, the control release member 23 and the adjusting mechanism moving member 25 can be in a locking state or a separation state by operating the locking switching device 24, and when the control release member 23 and the adjusting mechanism moving member 25 are in the locking state, the inner tube 3 and the adjusting mechanism 5 can synchronously move axially.
In one embodiment, when the valvular prosthesis 1 needs to be axially adjusted, the locking and switching device 24 is operated to enable the control release member 23 and the adjusting mechanism moving member 25 to be in a locked state, and the control release member 23 is continuously operated, so that the inner tube 3 and the adjusting mechanism 5 can synchronously and axially move under the condition that the outer sheath does not move, the valvular prosthesis 1 is connected with the adjusting mechanism 5, and the axial position of the valvular prosthesis 1 can be adjusted.
In one embodiment, when the valve prosthesis 1 is positioned/implanted at the desired position, the locking and switching device 24 is operated to keep the control release member 23 and the adjustment mechanism moving member 25 in a separated state, and at this time, the operation between the control release member 23 and the adjustment mechanism moving member 25 is not affected, the control release member 23 is operated to axially move the inner tube 3 relative to the transmission member 51 (i.e., the adjustment mechanism 5), so that the control release device 6 (i.e., the withdrawing sheath) is separated from the distal end portion of the valve prosthesis 1, and finally, the control release device 6 is separated from the other end portion of the valve prosthesis 1, and the distal end portion of the valve prosthesis 1 is released.
Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A valve delivery system capable of adjusting and positioning comprises a valve prosthesis, a control handle, an inner tube and an outer sheath, wherein the inner tube and the outer sheath are connected with the control handle in a matched mode.
2. The adjustably positionable valve delivery system of claim 1, wherein the control handle is provided with a control release member, a moving member of the adjustment mechanism, and a locking switch device, the control release member controlling axial movement of the control release member, the moving member of the adjustment mechanism controlling axial movement of the adjustment mechanism, the locking switch device being operable to lock or unlock the control release member and the moving member of the adjustment mechanism, the inner tube and the adjustment mechanism being synchronously axially movable when the control release member and the moving member of the adjustment mechanism are in the locked state.
3. The valve delivery system with adjustable positioning of claim 2, wherein when the valve prosthesis needs to be axially adjusted, the locking and switching device is operated to enable the valve delivery system to be in the locked state, and the inner tube and the adjusting mechanism can synchronously and axially move under the condition that the outer sheath is not moved by continuously operating the control release member or the moving member of the adjusting mechanism, so as to adjust the axial position of the valve prosthesis.
4. The adjustably positionable valve delivery system of claim 2, wherein when the valve prosthesis is positioned/implanted in the desired position, the locking switch is operated to release the other end portion of the valve prosthesis by operating the control release member while the valve delivery system is in the disengaged state.
5. The system of claim 1, wherein the adjustment mechanism comprises a transmission member coupled to the control handle, and a coupling member coupled to an end of the transmission member, the coupling member being coupled to an end of the valve prosthesis.
6. The adjustable positioning valve delivery system of claim 5, wherein the connecting member comprises a base fixedly connected to the other end of the driving member, and a plurality of connecting claws uniformly arranged on the base, and the connecting claws are provided with hole-shaped structures.
7. The adjustably positionable valve delivery system of claim 1, further comprising a stop member disposed on the inner tube, the stop member being coupled to the other end of the valve prosthesis when the implantation instrument is loaded with the delivery system.
8. The system of claim 1, wherein a rotational structure is disposed between the inner tube and the control release device, and the inner tube and the outer sheath remain stationary when the control handle is operated to rotate the adjustment mechanism to rotate the valve prosthesis and further rotate the control release device.
9. The adjustably positionable valve delivery system of claim 8, wherein the rotational structure comprises a protrusion disposed on the inner tube and a recess disposed in the control release device, the protrusion being disposed in the recess.
10. The system of claim 1, wherein a lumen is disposed between the inner and outer sheaths, the other end portion of the adjustment mechanism being disposed within the lumen, and a plurality of control wires being disposed within the lumen.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011087181.8A CN113796988A (en) | 2020-10-12 | 2020-10-12 | Valve conveying system capable of adjusting positioning |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011087181.8A CN113796988A (en) | 2020-10-12 | 2020-10-12 | Valve conveying system capable of adjusting positioning |
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| CN113796988A true CN113796988A (en) | 2021-12-17 |
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| CN202011087181.8A Pending CN113796988A (en) | 2020-10-12 | 2020-10-12 | Valve conveying system capable of adjusting positioning |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023236242A1 (en) * | 2022-06-09 | 2023-12-14 | 金仕生物科技（常熟）有限公司 | Valve delivery system |
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2020
- 2020-10-12 CN CN202011087181.8A patent/CN113796988A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023236242A1 (en) * | 2022-06-09 | 2023-12-14 | 金仕生物科技（常熟）有限公司 | Valve delivery system |
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