WO2017101232A1 - 人工心脏瓣膜支架、人工心脏瓣膜及植入方法 - Google Patents
人工心脏瓣膜支架、人工心脏瓣膜及植入方法 Download PDFInfo
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- WO2017101232A1 WO2017101232A1 PCT/CN2016/076778 CN2016076778W WO2017101232A1 WO 2017101232 A1 WO2017101232 A1 WO 2017101232A1 CN 2016076778 W CN2016076778 W CN 2016076778W WO 2017101232 A1 WO2017101232 A1 WO 2017101232A1
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- heart valve
- inflow
- inflow side
- skirt
- outflow
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A61B2017/00238—Type of minimally invasive operation
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- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
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- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
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- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
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- 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
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Definitions
- the present invention relates to the field of interventional medical devices, and in particular to a prosthetic heart valve stent, a prosthetic heart valve having the prosthetic valve stent, and an implantation method of the prosthetic heart valve.
- the heart valve grows between the atria and the ventricles, between the ventricles and the aorta, and acts as a one-way valve to help the blood flow in one direction.
- the four valves of the human body are called the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. If these valves have lesions, they will affect the movement of the bloodstream, causing abnormal heart function and eventually leading to heart failure.
- valvular lesion is usually narrow or incomplete.
- Stenosis refers to the insufficient opening of the valve, resulting in a decrease in blood entering the next heart chamber; incomplete closure means that the valve is not tight, resulting in partial blood reflux.
- stenosis and/or insufficiency occurs, it will impede normal blood flow and increase the corresponding burden on the heart, causing normal functional damage of the heart, leading to heart failure and changes in the body's multiple organ function.
- valvular heart disease is mainly divided into two methods: 1) valvuloplasty, which repairs the damaged valve; 2) valve replacement, which is replaced by artificial mechanical or biological valve.
- Valvuloplasty is commonly used for mild mitral or tricuspid valves, and for severe heart valve disease, especially rheumatic valvular disease, valve replacement is often used.
- the main methods of valvuloplasty are Key's forming, DeVega forming, and forming by C-ring.
- Valve replacement uses artificial valves to replace human diseased heart valves, such as mechanical and biological valves.
- the mechanical valve has a long life, but it needs to take antibiotics for life and is prone to complications.
- the biological valve does not need life-time anticoagulation, but has a short life span.
- the right heart system of the human heart (shown in Figure 1) includes the right atrium 3 and the right ventricle 5; the left heart system of the human heart includes the left atrium 4, the left ventricle 6, and the mitral annulus between the left atrium 4 and the left ventricle 6 8, mitral anterior leaflet 15, mitral posterior leaflet 12, and chordae 16.
- Prior art prosthetic valve devices include a anterior leaflet anchor and a posterior leaflet anchor. The anterior leaflet anchor and the posterior leaflet anchor are respectively fixed to the mitral valve leaflet 15 and the mitral valve leaflet 12 to prevent the prosthetic valve device from falling off to the left atrium 4 under the impact of blood flow.
- the leaflet tissue is relatively fragile.
- the anterior leaflet anchor 4 and the posterior leaflet anchor 3 are not only easy to damage the leaflets, but also easily fall off from the leaflets, thereby directly causing the artificial heart valve to be on the heart valve tissue. Poor stability affects the life of the prosthetic heart valve and increases the risk of the patient replacing the valve again.
- the prosthetic heart valve stent can be stably disposed on the heart valve tissue. Prolongs the life of the prosthetic heart valve and reduces the risk of the patient replacing the valve again.
- the present invention provides a prosthetic heart valve stent comprising a tubular stent body having opposing inflow-side and outflow-side ends, an inflow-side skirt surrounding the outer wall of the stent body, and an outflow side surrounding the outer wall of the stent body Skirt.
- a prosthetic heart valve stent comprising a tubular stent body having opposing inflow-side and outflow-side ends, an inflow-side skirt surrounding the outer wall of the stent body, and an outflow side surrounding the outer wall of the stent body Skirt.
- the free ends of the inflow side skirt and the outflow side skirt both extend toward the inflow side end side, and the inflow side skirt is configured to cooperate with the outflow side skirt to clamp the heart valve organization.
- the prosthetic heart valve stent further includes a tubular connecting bracket surrounding the outer wall of the stent body, the inflow side skirt and the inflow side skirt being respectively located at opposite ends of the tubular connecting bracket.
- tubular connecting bracket and the main body bracket are separately formed separately and fixedly connected together.
- the projection of the end of the inflow side skirt associated with the tubular stent body in a section parallel to the longitudinal central axis of the tubular stent body, with the inflow side end are phase separated.
- the distance between the end of the inflow side skirt that is connected to the tubular bracket body and the inflow side end is greater than or equal to the tubular shape of the outflow side skirt The distance between the end of the bracket body and the end of the outflow side.
- the projection of the end of the outflow side skirt associated with the tubular stent body in a section parallel to the longitudinal central axis of the tubular stent body, with the outflow side end are phase separated.
- the inflow side skirt includes an inflow side clamping portion connected to the bracket body, and an inflow side lifting portion connected to the inflow side clamping portion, the inflow side clamping a portion between the inflow-side tilting portion and the bracket body, the end portion of the inflow-side tilting portion away from the inflow-side grip portion being a free end of the inflow-side skirt, and the inflow The side lifted portion has an angle with the inflow side sandwiching portion.
- the inflow side lift portion includes an inflow side wave structure surrounding the holder body.
- the outflow side skirt includes an outflow side clamping portion connected to the bracket body, and an outflow side lifting portion connected to the outflow side clamping portion, the outflow side clamping a portion between the outflow side lifting portion and the bracket body, the end portion of the outflow side lifting portion away from the outflow side clamping portion is a free end of the outflow side skirt, and the outflow The side raised portion has an angle with the outflow side clamping portion.
- the inflow side skirt includes a plurality of first skirt subunits that are separated from one another, each of the first skirt subunits being disposed on the bracket body by a braiding method.
- the inflow side skirt is provided with a plurality of inflow side anchors, and the free end of the inflow side anchor on the inflow side skirt extends toward the outflow side end side.
- the distance between the end of the inflow side skirt that is connected to the tubular stent body and the end of the outflow side skirt that is connected to the tubular stent body ranges from 2 to 6 mm.
- a plurality of connecting elements are provided on the free end of the inflow side skirt.
- At least one of the inflow side skirt and the outflow side skirt is covered with a baffle.
- the present invention also provides a prosthetic heart valve comprising the prosthetic heart valve stent and the leaflets described above, the leaflets being disposed inside the tubular stent body.
- the invention also provides a method for implanting an interventional medical device, comprising: forming a small incision on the right chest to expose the atrium, and feeding the artificial heart valve to the implantation site of the cardiac system through the small incision, and fixing On the organization of the heart system.
- the heart valve is an artificial mitral valve
- the step of delivering the heart valve through the small incision to the implantation site of the cardiac system Previously, the implantation method further included the step of delivering a guidewire through the small incision to the left ventricle.
- the feeding of the guide wire through the small incision to the left ventricle includes the steps of: sewing a purse-shaped purse on the wall of the atrium; feeding the tip of the puncture needle into the left atrium through the sputum purse; And the distal end of the guide wire is sent into the left atrium along the lumen of the puncture needle, and enters the left ventricle through the mitral valve.
- the feeding of the guide wire through the small incision to the left ventricle includes the steps of: suturing a purse-type purse on the right atrium wall; passing the tip of the radiofrequency perforating needle through the crotch-type purse, right The atrium and the atrial septum are delivered to the left atrium; and the distal end of the guidewire is delivered into the left atrium along the lumen of the radiofrequency perforating needle and into the left ventricle through the mitral valve.
- the feeding of the guide wire through the small incision to the left ventricle includes the steps of: sewing a purse-like purse around the pre-puncture position of the chamber ditch; and sending the tip of the puncture needle through the crotch-type purse Entering the left atrium; and feeding the distal end of the guide wire into the left atrium along the lumen of the puncture needle and into the left ventricle through the mitral valve.
- the inflow side skirt and the outflow side skirt of the artificial heart valve stent of the present invention cooperate with the heart valve tissue, so that the artificial heart valve stent can be stably disposed on the heart valve tissue, and the artificial heart is extended.
- the lifespan of the prosthetic heart valve of the valve stent reduces the risk of the patient replacing the valve again.
- the implantation method of the present invention has at least the following advantages: (1) during the surgical operation of the present invention, no extracorporeal circulation is required, and the hazard of surgical trauma is avoided; (2) the surgical operation of the present invention During the process, the small chest incision is punctured, and the vascular path is not required.
- the size of the interventional medical device is not limited by the size of the blood vessel, which is advantageous for the flexibility of the structural design of the interventional medical device; (3) during the surgical operation of the present invention, The right atrial puncture with lower blood flow pressure than the left ventricle blood flow pressure and thinner muscle layer, no puncture point or less bleeding and easy puncture; (4) The interventional medical device recovery device of the present invention is disposed in the left atrium.
- the delivery device carrying the interventional medical device is far away from the sling, and the delivery device or the interventional medical device is prevented from touching the sling It reduces the occurrence of chordae winding device or interventional medical device, making the operation safer.
- Figure 1 is a schematic diagram of a human heart system
- FIG. 2 is a schematic diagram of an interventional medical device replacement system according to a first embodiment of the present invention
- Figure 3 is a schematic illustration of the delivery device of the interventional medical device replacement system of Figure 2;
- Figure 4 is a cross-sectional view taken along line IV-IV of Figure 3;
- Figure 5 is an enlarged view of the portion P in Figure 3;
- Figure 6 is a partial structural schematic view of the push rod drive assembly of the transport device of Figure 2;
- Figure 7 is an enlarged view of the portion Q in Figure 3;
- Figure 8 is a partial structural schematic view of the sheath driving assembly of the delivery device of Figure 2;
- Figure 9 is an enlarged view of M in Figure 3.
- Figure 10 is a schematic view showing the state in which the stopper in the connecting assembly of the conveying device of Figure 2 is connected to the connecting member;
- Figure 11 is a schematic view of the delivery device of Figure 2 connected to an interventional medical device
- Figure 12 is a schematic structural view of the interventional medical device of Figure 2;
- Figure 13 is a schematic illustration of the stent of the interventional medical device of Figure 13;
- Figure 14 is a schematic view of the stent of the interventional medical device of Figure 12 with the obstruction film removed;
- Figure 15 is a schematic structural view of the stent body of the stent of Figure 14;
- Figure 16 is a schematic view of the annulus seal of Figure 14 after removal of the baffle;
- Figure 17 is an enlarged view of N in Figure 16;
- Figure 18 is a plan view of Figure 16 as seen from the side of the outflow side skirt.
- Figure 19 is a schematic view of the pouch after the pouch is placed at the right atrial appendage
- Figure 20 is a schematic view of the puncture needle after entering the left atrium through the purse of Figure 19;
- Figure 21 is a schematic view of the guide wire after passing through the lumen of the puncture needle of Figure 20 to the left ventricle;
- Figure 22 is a schematic view of measuring the size of the annulus
- Figure 23 is a schematic view of the delivery device loaded with the interventional medical device after the guide wire reaches the mitral valve;
- Figure 24 is a schematic illustration of the portion of the interventional medical device in the cardiac system exposed from the delivery device
- Figure 25 is a schematic view showing the positional relationship between the partially exposed interventional medical device and the delivery device
- Figure 26 is a schematic illustration of all of the interventional medical devices in the cardiac system exposed from the delivery device
- Figure 27 is a schematic illustration of the positional relationship between the fully exposed interventional medical device and the delivery device
- FIG. 28 is a schematic illustration of a post-release interventional medical device in a cardiac system
- Figure 29 is a schematic view of the interventional medical device completely separated from the delivery device
- Figure 30 is a schematic view of the inner sheath core and the outer sheath tube of the delivery device after being closed;
- Figure 31 is a schematic view of the inner sheath core and the outer sheath tube in the heart system
- Figure 32 is a schematic view of the guide wire after entering the left atrium through the delivery device
- Figure 33 is a schematic view showing the occlusion device sealing the interatrial septum and ligating the purse;
- Figure 34 is a schematic view of the second implantation method after the puncture needle passes through the purse into the right atrium;
- Figure 35 is a schematic view of the distal end of the guide wire taken along the lumen of the puncture needle of Figure 34 to the right atrium;
- Figure 36 is a schematic view of the puncture needle of Figure 35 after being withdrawn from the right atrium;
- Figure 37 is a schematic view of the distal end of the delivery sheath taken along the guide wire of Figure 36 to the right atrium;
- Figure 38 is a schematic view of the guide wire of Figure 37 after being withdrawn from the right atrium;
- 39 is a schematic view of the distal end of the delivery sheath of FIG. 38 after the distal end of the puncture needle or radiofrequency perforating needle is delivered to the left atrium through the interatrial septum;
- Figure 40 is a schematic view of the distal end of the guide wire after the distal end of the guide wire is delivered to the left ventricle via the internal cavity of the puncture needle or the radio frequency perforating needle of Figure 39;
- Figure 41 is a schematic view showing the arrangement of two purses on the front atrium of the right atrium in the third implanting method
- Figure 42 is a schematic view of the two puncture needles entering the left atrium through the two purses of Figure 41;
- Figure 43 is a schematic view of the two guide wires after entering the left atrium through the lumens of the two puncture needles in Figure 42;
- Figure 44 is a schematic view of the puncture needle after withdrawal from the cardiac system
- Figure 45 is a schematic illustration of the distal end of the delivery sheath with the dilator through the guidewire into the left atrium;
- Figure 46 is a schematic view of the surgical aid device after being delivered to the left atrium via the delivery sheath;
- Figure 47 is a schematic illustration of the distal end of a delivery device loaded with an interventional medical device after another guidewire has reached the mitral valve;
- 48 is a schematic view showing an occluder for sealing two interatrial septal puncture holes and ligating two purses;
- Figure 49 is a schematic view showing a pre-puncture position on a room ditch in the fourth planting method
- Figure 50 is a schematic view showing the pouch after the pouch is placed around the pre-piercing position in Figure 49;
- Figure 51 is a schematic view of the puncture needle after entering the left atrium through the purse of Figure 50;
- Figure 52 is a schematic view of the interventional medical device after implantation through the chamber
- 53 is a schematic view of a stent for an interventional medical device according to still another embodiment of the present invention.
- Figure 54 is a schematic view showing the outflow side skirt and the baffle cloth of the holder of Figure 53;
- Figure 55 is a plan view of Figure 54;
- Figure 56 is a schematic view showing the inflow side skirt and the choke cloth of the holder of Figure 53;
- Figure 57 is a plan view of Figure 56.
- an element when referred to as being “fixed” to another element, it can be directly on the other element or the element can be present. When an element is considered to be “connected” to another element, it can be directly connected to the other element or.
- the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.
- the implantation method of the interventional medical device of the present invention is described by taking an artificial heart valve implanted with a mitral valve as an example, and the concept of the present invention can also be used for implanting a left atrial appendage occluder, atrial septum. Interventional medical devices such as defect occlusion devices.
- the heart valve tissue according to the present invention refers to a combination of one or several kinds of tissues in heart tissue such as an annulus, a leaflet, a chordae, and a papillary muscle.
- the prosthetic heart valve is contracted in the delivery device to facilitate delivery; in the deployed state, the prosthetic heart valve is detached from the delivery device, and radially expanded to fit and integrate with the heart tissue.
- the interventional medical device replacement system 100 includes a delivery device 40, an interventional medical device 50, and a loader (not shown).
- the interventional medical device 50 is loaded onto the delivery device 40 using a loader and the interventional medical device 50 is transported to the implantation site of the cardiac system using the delivery device 40 to complete the implantation of the interventional medical device 50.
- the interventional medical device 50 is a manual mitral valve; the delivery device 40 implants the interventional medical device 50 onto the mitral valve 2 of the cardiac system.
- the delivery device 40 includes an operating handle 41, a push rod 42, an outer sheath tube 43, an inner sheath core 44, and an instrument connection assembly 48.
- the operating handle 41 includes a handle housing 45, a push rod drive assembly 46, and a sheath drive assembly 47.
- the handle housing 45 includes an upper case 451 and a lower case 453 having an outer diameter different from the outer diameter of the upper case 451.
- the upper case 451 and the lower case 453 are assembled to have an eccentric structure.
- the outer diameter of the upper case 451 is smaller than the outer diameter of the assembly having the smaller outer diameter of the push rod drive assembly 46 and the sheath drive assembly 47
- the outer diameter of the lower case 453 is greater than the push rod drive assembly 46 and The outer diameter of the assembly having a larger outer diameter in the sheath drive assembly 47.
- the push rod driving assembly 46 and the sheath driving assembly 47 can be partially located in the outer casing 45, but also the push rod driving assembly 46 and the sheath driving assembly 47 can be partially located outside the outer casing 45, facilitating the operator to operate outside the outer casing 45.
- the push rod drive assembly 46 and the sheath drive assembly 47 can be partially located outside the outer casing 45, facilitating the operator to operate outside the outer casing 45.
- the upper casing 451 is provided with a first receiving hole 455 and a second receiving hole 457 (see FIG. 3) communicating with the inner cavity of the outer casing 45.
- the shape of the first receiving hole 455 in the cross section including the longitudinal central axis of the outer casing 45 is T-shaped, and the outer diameter of the end of the first receiving hole 455 close to the inner cavity of the outer casing 45 is larger than the outer side of the first receiving hole 455 near the outer casing 45.
- the outer diameter of the end portion of the push rod driving assembly 46 is partially received in the inner portion of the outer casing 45 and the first receiving hole 455, and is partially exposed from the first receiving hole 455.
- the shape of the second receiving hole 457 in the cross section including the longitudinal center axis of the outer casing 45 is T-shaped, and the outer diameter of the end of the second receiving hole 457 close to the inner cavity of the outer casing 45 is larger than the outer side of the second receiving hole 457 close to the outer casing 45.
- the outer diameter of the end portion; the sheath driving assembly 47 is partially received in the inner portion of the outer casing 45 and the second receiving hole 457, and partially exposed from the second receiving hole 457.
- a portion of the inner wall of the lower casing 453 is recessed toward the outer casing to form a first receiving groove 458 corresponding to the first receiving hole 455 and a second receiving groove 459 corresponding to the second receiving hole 457.
- the shape of the first receiving groove 458 on the cross section including the longitudinal center axis of the outer casing 45 is T-shaped, and the outer diameter at the notch of the first receiving groove 458 is larger than the outer diameter of the groove bottom of the first receiving groove 458.
- the shape of the first receiving groove 458 on the cross section including the longitudinal center axis of the outer casing 45 is T-shaped, and the outer diameter at the notch of the first receiving groove 458 is larger than the outer diameter of the groove bottom of the first receiving groove 458.
- the push rod driving assembly 46 includes a first supporting tube 461 , a first rotating barrel 463 surrounding the first supporting tube 461 , and being received in the first supporting tube 461 and along the first support A hollow first slider 465 is moved by the longitudinal central axis of the tube 461.
- the first support tube 461 is received in a space formed by the first receiving hole 455 and the first receiving groove 458 , and is fixed to the inner wall of the outer casing 45 .
- the side walls at both ends of the first support tube 461 are provided with a first annular groove 462 surrounding the longitudinal center line of the first support tube 461 in the circumferential direction of the first support tube 461.
- the side wall of the first support tube 461 is provided with two opposite first guide holes 464 which are elongated and framed and located between the two first annular grooves 462 along the length direction of the first support tube 461.
- the first rotating cylinder 463 surrounds the first supporting tube 461, and one end thereof is movably received in one first annular groove 462, and the other end is movably received in the other first annular groove 462.
- An internal thread 466 is provided on the inner wall of the first rotating cylinder 463.
- the inner diameter of the two ends of the first rotating cylinder 463 is smaller than the inner diameter of the other portions of the first rotating cylinder 463, so that the end of the first rotating cylinder 463 can be received in the first annular groove 462, and the first The intermediate portion of the spinner 463 can be separated from the first support tube 461; the first spinner 463 includes opposing and connected two half-shells 467 (shown in Figure 4).
- the first spinner 463 includes opposing and connected two half-shells 467 (shown in Figure 4).
- the two ends of one half-shell 467 are respectively placed in the two first annular grooves 462, and the two ends of the other half-shell 467 are respectively placed.
- the two first annular grooves 462 are respectively engaged with the two ends of the half-shell 467 which have been inserted into the first annular groove 462 into a single body.
- the first slider 465 is received in the first support tube 461, and two first guiding holes 464 are respectively protruded from opposite sides of the first slider 465.
- the first slider 465 is threadedly coupled to the first drum 463.
- the rotating first rotating cylinder 463 drives the first slider 465 to move axially along the first guiding hole 464.
- the distal end of the first slider 465 is coupled to the push rod 42 such that axial movement of the first slider 465 can cause the push rod 42 to move axially.
- the first slider 465 has a T-shaped structure, and the proximal end outer diameter of the first slider 465 is larger than the outer diameter of the distal end thereof, and the proximal end thereof is received in the first support tube 461, and the distal end The first support tube 461 is protruded.
- the first slider 465 is provided with a T-shaped axial through hole 468 extending through the proximal end surface and the distal end surface thereof.
- the outer diameter of the distal end of the axial through hole 468 is larger than the outer diameter of the proximal end of the axial through hole 468, and the outer diameter of the distal end of the axial through hole 468 is slightly larger than the outer diameter of the push rod 42 so that the push rod 42 can be received in the shaft.
- the through hole 468 is slightly larger than the outer diameter of the push rod 42 so that the push rod 42 can be received in the shaft.
- the first slider 465 includes a knob connection 469 near its proximal end.
- the drum connecting portion 469 is substantially a rectangular parallelepiped structure, and the opposite parallel side walls are respectively in contact with the inner wall opposite to the first supporting tube 461, and the other pair of parallel side walls are respectively provided with the internal thread 466. Teeth 4691 used.
- the sheath driving assembly 47 includes a second supporting tube 471, a second rotating barrel 472 surrounding the second supporting tube 471, and being received in the second supporting tube 471 and along the second supporting tube.
- a hollow second slider 473 which has a longitudinal central axis of 471, and a bend unit 474.
- the second support tube 471 is received in a space formed by the second receiving hole 457 and the second receiving groove 459 and is fixed to the inner wall of the outer casing 45.
- the side walls of both ends of the second support tube 471 are each provided with a second annular groove 475 surrounding the longitudinal center line of the second support tube 471 in the circumferential direction of the second support tube 471.
- the side wall of the second support tube 471 is provided with two opposite second guide holes 476 which are formed in an elongated frame shape and located between the two second annular grooves 475 along the length direction of the second support tube 471.
- the second rotating cylinder 472 surrounds the second supporting tube 471, and one end thereof is movably received in one second annular groove 475, and the other end is movably received in the other second annular groove 475.
- the structure of the second rotating drum 472 is the same as that of the first rotating drum 463, and the second rotating drum 472 also includes the internal thread 477; the size of the second rotating drum 472 is the same as that of the first rotating drum 463.
- the dimensions are also the same and will not be described here. It can be understood that in other embodiments, the size of the second rotating drum 472 and the size of the first rotating drum 463 may also be different, and are set according to actual needs.
- the second slider 473 is received in the second support tube 471, and two second guiding holes 476 are respectively protruded from opposite sides of the second slider 473.
- the second slider 473 is threadedly coupled to the second drum 472.
- the rotating second rotating cylinder 472 drives the second slider 473 to move axially along the second guiding hole 476.
- the distal end of the second slider 473 is coupled to the proximal end of the outer sheath tube 43, such that axial movement of the second slider 473 can cause the outer sheath tube 43 to move axially.
- the second slider 473 is further provided with an axial through hole 478 extending through the proximal end surface and the distal end surface thereof.
- the axial through hole 478 has a larger diameter than the outer diameter of the push rod 42 so that the proximal end of the push rod 42 can be connected to the first slider 465 through the sheath driving assembly 47, and the push rod 42 can be opposite to the second support tube 471. Moving in the axial direction of the second support tube 471.
- the second slider 473 includes a knob connection 479 near its proximal end.
- the drum connecting portion 479 is substantially a rectangular parallelepiped structure, the opposite parallel side walls are respectively in contact with the inner wall opposite to the second supporting tube 471, and the other pair of parallel side walls are respectively provided with the internal thread 477. Teeth 4791 used.
- the adjusting unit 474 is for adjusting the angle of the distal end of the outer sheath tube 43, and includes a pulling wire 4741 connected to the distal end of the outer sheath tube 43 and a driving member 4742 for driving the pulling wire 4741 to move.
- the proximal end of the driving member 4742 is connected to the distal end of the pulling wire 4741, and the distal end protrudes from the outer casing 45, so that the operator can operate the driving member 4742 to drive the pulling wire 4741 to perform the turning of the distal end of the outer sheath tube 43.
- the structure and principle of the driving member 4742 can be the same as the structure and principle of the push rod driving assembly 46.
- the slider of the driving member 4742 is connected with the pulling wire 4741, and the slider of the driving member 4742 is in the rotating barrel.
- the purpose of the present invention can be achieved by driving the lower pulling wire 4741 to move, and details are not described herein again.
- the push rod 42 is received in the outer sheath tube 42 and surrounds the inner sheath core 44.
- the proximal end of the push rod 42 is coupled to the push rod drive assembly 46, and the distal end of the push rod 42 extends out of the outer casing 411 and extends toward the distal end of the delivery device 40.
- Rotating the first knob 463 drives the first slider 465 to move the push rod 42 axially relative to the outer casing 411.
- the outer sheath tube 43 surrounds the push rod 42 and has a proximal end coupled to the sheath drive assembly 47, the distal end of which extends out of the outer casing 411 and extends toward the distal end of the delivery device 40.
- Rotating the second rotating cylinder 472 drives the second sliding block 473 to drive the outer sheath tube 43 to move axially relative to the outer casing 411.
- the inner sheath core 44 is received in the push rod 42 and its proximal end passes through the sheath drive assembly 47, the push rod drive assembly 46, and is connected to the outer casing 411.
- the distal end of the inner sheath core 44 passes out of the outer casing 411 and is farther from the operating handle 41 than the distal end of the push rod 42.
- the instrument connection assembly 48 includes a connector 481 disposed at the distal end of the push rod 42 and a stopper 483 disposed on the inner sheath core 44.
- the connector 481 cooperates with the stop 483 to control the connection and release between the medical device 50 and the delivery device 40.
- the connector 481 includes a plurality of connecting rings 485 and a plurality of connecting posts 487.
- One end of each connecting ring 485 is connected to the push rod 42 and the other end is a free end.
- One end of each connecting post 487 is connected to the push rod 42 and the other end is a free end, and the free end of each connecting post 487 faces the upper stop 483.
- the non-free end of each connecting ring 485 and the non-free end of the connecting post 487 are connected to the distal end surface of the push rod 42; the number of connecting posts 487 is equal to the number of connecting rings 485, and more
- the connecting rings 485 are in one-to-one correspondence with the plurality of connecting posts 487.
- Each connecting ring 485 is adjacent to a respective connecting post 487.
- the stop 483 is disposed at the distal end of the inner sheath core 44 and is closer to the distal end of the delivery device 40 than the connector 481.
- the stopper 483 is provided with a plurality of receiving bodies 489 for receiving the connecting posts 487 enclosing the connecting ring 485.
- the connecting ring 485 After the free end of the to-be-connected ring 485 passes through the interventional medical device 50, the free end of the connecting ring 485 is sleeved on the connecting post 487; after the connecting post 487 of the connecting ring 485 is received in the receiving body 489, the connecting ring The 485 will not be detached from the connecting post 487 under the action of external force, and the interventional medical device 50 is connected to the conveying device 40; the connecting column 487 to be sheathed with the connecting ring 485 is separated from the receiving body 489 by external force, and the medical intervention is performed. The instrument 50 is separated from the delivery device 40 to complete the release of the interventional medical device 50.
- the stopper 483 surrounds the inner sheath core 44 and is fixed to the outer wall of the inner sheath core 44; the receiving body 489 is a through hole penetrating the proximal end and the distal end of the stopper 483; the number of the receiving body 489
- the number of the connecting columns 487 is equal, and the plurality of receiving bodies 489 are in one-to-one correspondence with the plurality of connecting columns 487.
- the diameter of each of the receiving bodies 489 is greater than or equal to the outer diameter of the corresponding connecting post 487, so as to facilitate a connecting column.
- the 487 can be housed in the corresponding housing 489.
- the connecting medical device 50 and the conveying device are connected by a connecting ring 485, and the connecting ring 485 is a soft structure, which is not easy to cause human tissue damage, and has a simple structure and is easy to manufacture.
- the interventional medical device 50 is used for replacing a diseased mitral valve, which includes a prosthetic heart valve stent 10 and a prosthetic leaflet disposed in the prosthetic heart valve stent 10 . 30.
- the prosthetic heart valve stent 10 includes a tubular stent body 11 and an annulus seal 13 that surrounds the outer wall of the stent body.
- the stent body 11 and the annulus seal 13 are separately molded and then integrally fixed, thereby improving the overall strength of the artificial heart valve stent 10 and prolonging the life of the interventional medical device 50.
- the tubular stent body 11 is a mesh structure formed by wire braiding or tube cutting and shaping, and is used to carry the artificial leaflets 30.
- the tubular stent body 11 is a mesh structure cut and shaped by a nickel-titanium metal pipe.
- the nickel-titanium wire can be woven and shaped to form the stent body, or a polymer fiber made of a polymer material (for example, polycarbonate filament, polypropylene filament, poly.
- the amide filament is woven or a polymer tube made of a polymer material is cut and shaped to form a stent body.
- the bracket body 11 includes opposing inflow side end portions 111 and outflow side end portions 113.
- a plurality of solder joints 115 are provided on the pattern of the holder main body 11.
- a plurality of solder joints 115 are evenly spaced along the same circumferential direction of the stent body 11, and a plurality of solder joints 115 are coaxial with the central axis of the stent body 11 for soldering to the annulus seal 13.
- the outline of the solder joint 115 is a polygon, and the inscribed circle diameter of the polygon is 0.5 mm to 2 mm, which is at least larger than the diameter of the weld pool.
- the distance between the center of the pad 115 and the end portion 111 of the inflow side is greater than the distance between the center of the pad 115 and the end portion 113 of the outflow side.
- the annulus seal 13 includes a hollow tubular connecting bracket 131 for attaching the bracket body 11, an inflow side skirt 133 connected to one end of the tubular connecting bracket 131 and extending outward, and a tubular shape.
- An outflow side skirt 134 which is connected to the other end of the bracket 131 and extends outward, and a baffle cloth 135.
- the connecting bracket 131 is a mesh structure formed by wire braiding or pipe cutting and shaping.
- the connecting bracket 131 is a mesh structure cut and shaped by a nickel-titanium metal pipe; the inflow side skirt 133, the outflow side skirt 134 and the tubular connecting bracket 131 are integrally formed.
- the nickel-titanium wire can be woven and shaped to form a connecting bracket, or a polymer fiber made of a polymer material (for example, polycarbonate wire, polypropylene wire, poly.
- the amide silk is woven or the polymer tube made of a polymer material is cut and shaped to form a joint bracket.
- Both the inflow side skirt 133 and the free end of the outflow side skirt 134 extend toward the inflow side end portion 111 side.
- the inflow side skirt 133 is configured to cooperate with the outflow side skirt 134 to hold the prosthetic heart valve tissue.
- the distance between the end of the inflow side skirt 133 that is connected to the bracket body 11 and the end of the outflow side skirt 134 that is connected to the bracket body 11 ranges from 2 to 6 mm.
- a baffle cloth 135 is provided on at least one of the inflow side skirt 133 and the outflow side skirt 134 for preventing backflow of blood flow at the annulus seal 13 to prevent paravalvular leakage.
- the heart valve tissue that is engaged with the inflow side skirt 133 and the outflow side skirt 134 is an annulus 8, a leaflet 15 and a leaflet 12; the choke cloth 135 is disposed on the inflow side skirt 133.
- the surface of the outflow side end portion 113, the outer wall of the connection bracket 131 between the inflow side skirt 133 and the outflow side skirt 134, and the outflow side skirt 134 face the surface of the inflow side end portion 111.
- the baffle cloth 135 may be disposed only on the inflow side skirt 133 or the outflow side skirt 134.
- connection bracket 131 is provided with a plurality of solder joints 1311.
- the solder joints 1311 and the solder joints 115 on the bracket body 11 are mated and welded.
- the shape and size of the solder joints 1311 are the same as those of the solder joints 115, and the soldering may be laser welding or electric resistance welding.
- the inflow side skirt 133 surrounds the tubular connecting bracket 131, and includes an inflow side clamping portion 1331 connected to the connecting bracket 131 and surrounding the connecting bracket 131, and an inflow side clamping portion. 1331 is connected and surrounds the inflow side lift portion 1333 of the inflow side grip portion 1331. The inflow side clamping portion 1331 is located between the inflow side lifting portion 1333 and the connection bracket 131.
- the end portion of the inflow side skirt 133 connected to the tubular bracket main body 11 is parallel to the longitudinal central axis of the tubular bracket main body 11
- the upper projection is separated from the projection of the inflow side end portion 111 in a section parallel to the longitudinal center axis of the tubular holder main body 11, that is, the inflow side skirt 133 is coupled to the bracket main body 11 except the inflow side end portion 111.
- the inflow side skirt 133 can also be coupled to the inflow side end portion 111 of the bracket body 11.
- the inflow side clamping portion 1331 is connected between the connection bracket 131 and the inflow side lifting portion 1333, and is formed to extend outward from the outer wall of the connection bracket 131.
- the inflow-side clamping portion 1331 is substantially parallel to a section perpendicular to the longitudinal central axis of the connection bracket 131 in the deployed state; the inflow-side clamping portion 1331 includes a plurality of diamond-shaped meshes 1334. The centers of the plurality of diamond meshes 1334 are joined to form an annular structure surrounding the connection brackets 131.
- the inflow-side lifted portion 1333 is formed to extend from the outer edge of the inflow-side sandwiching portion 1331 toward the side closer to the inflow-side end portion 111 side.
- the end portion of the inflow-side lifted portion 1333 which is away from the inflow-side grip portion 1331 is the free end of the inflow-side skirt 133, and has a clip between the inflow-side lift portion 1333 and the inflow-side grip portion 1331 in the unfolded state. angle.
- the inflow side skirt 133 is then carried on the mitral annulus 6 after the instrument is inserted into the medical device, avoiding the edge of the inflow side skirt 133 from cutting the left atrium.
- the degree of the angle between the inflow-side lifted portion 1333 and the inflow-side grip portion 1331 is ninety degrees. It can be understood that the degree of the angle between the inflow-side lifting portion 1333 and the inflow-side clamping portion 1331 in the unfolded state may be thirty degrees, sixty degrees, or one hundred twenty degrees, etc., as needed. The set degree is not limited to ninety degrees in the present embodiment.
- a plurality of connecting members 1335 for connecting a conveying system are provided on the edge of the inflow-side lifting portion 1333 which extends toward the inflow-side end portion 111 side.
- the edge of the free end of the inflow-side tilting portion 1333 forms an inflow-side wave structure surrounding the connection bracket 131, and the connecting member 1335 is a connecting hole and is located on the peak of the inflow-side wave structure.
- the connecting element 1335 can also be a connecting hook.
- the inflow side skirt 133 is further provided with an inflow side anchor having a plurality of free ends facing the left ventricle side (that is, the side of the outflow side end portion 113). It can also be understood that the inflow side anchor may be provided on the inflow side lifting portion 1333, and may be set according to actual needs.
- the outflow side skirt 134 surrounds the tubular connecting bracket 131 , and includes an outflow side clamping portion 1341 that is connected to the connecting bracket 131 and surrounds the connecting bracket 131 and is clamped to the outflow side.
- the portion 1341 is connected and surrounds the outflow side lift portion 1343 of the outflow side grip portion 1341.
- the outflow side clamping portion 1341 is located between the outflow side lifting portion 1343 and the connection bracket 131.
- the projection of the end portion of the outflow side skirt 134 connected to the bracket main body 11 in a section parallel to the longitudinal central axis of the bracket main body 11 is parallel to the bracket main body 11 with the outflow side end portion 133.
- the projections on the section of the longitudinal central axis are phase separated, and the distance between the end of the outflow side skirt 134 connected to the bracket body 11 and the outflow side end 113 is smaller than that of the inflow side skirt 133 connected to the bracket body 11.
- the distance between the end of the end and the end of the inflow side 111 to reduce the risk of obstruction of the outflow tract.
- outflow side skirt 134 can also be connected to the outflow side end portion 113 of the bracket body 11. It will also be understood that the distance between the end of the outflow side skirt 134 that is connected to the bracket body 11 and the outflow side end 113 may also be equal to the end of the inflow side skirt 133 that is connected to the bracket body 11 and the inflow. The distance between the side ends 111.
- the outflow side clamping portion 1341 is connected between the connection bracket 131 and the outflow side lifting portion 1343, and is formed to extend outward from the outer wall of the connection bracket 131.
- the distance between the end of the outflow-side clamping portion 1341 connected to the connection bracket 131 and the end of the inflow-side clamping portion 1331 connected to the connection bracket 131 ranges from 2 to 6 mm.
- the outflow-side clamping portion 1341 and the longitudinal center axis of the connection bracket 131 form an acute angle; the end portion of the outflow-side clamping portion 1341 connected to the connection bracket 131 and the inflow-side clamping portion 1331
- the distance between the ends connected to the connecting bracket 131 is 6 mm; the distance between the outflow-side clamping portion 1341 and the inflow-side clamping portion 1331 along the longitudinal central axis of the connecting bracket 131 gradually increases outward from the connecting bracket 131 Reduced.
- the outflow side lifted portion 1343 is formed to extend from the outer edge of the outflow side sandwiching portion 1341 toward the side closer to the inflow side end portion 111 side.
- the end of the outflow side lift portion 1343 away from the outflow side grip portion 1341 is the free end of the inflow side skirt 133.
- the outflow side lift portion 1343 is an outflow side wave structure surrounding the bracket body 11, and the outflow side lift portion 1343 is parallel to the longitudinal center axis of the joint bracket 131 in the unfolded state.
- a plurality of outflow side anchors 1347 are also disposed on the outflow side skirt 134.
- the free end of the outflow side anchor 1347 faces the left ventricle side (that is, the side of the outflow side end 113).
- the anchor 1347 is used to secure the prosthetic heart valve 100 to the annulus 8 as the prosthetic heart valve 100 is deployed.
- the outflow side anchor 1347 is provided on the peak of the outflow side wave structure of the outflow lifted portion 1343. It can be understood that the outflow side anchor 1347 can also be disposed on the outflow side clamping portion 1341, and can be set according to actual needs.
- the artificial heart valve in the embodiment of the invention has the following obvious advantages:
- the inflow side skirt of the artificial heart valve stent cooperates with the outflow side skirt to hold the artificial heart valve tissue, so that the artificial heart valve stent can be stably placed on the artificial heart valve tissue, and the prosthetic heart valve stent is extended.
- the lifespan of the prosthetic heart valve reduces the risk of the patient replacing the valve again.
- the artificial heart valve stent is provided with an anchoring member to improve the stability of the artificial heart valve having the prosthetic heart valve stent after implantation.
- the artificial heart valve stent is provided with a obstruction cloth, which can effectively prevent the occurrence of paravalvular leakage after prosthetic heart valve implantation;
- the delivery device 40 and the interventional medical device 50 need to be separately packaged.
- the interventional medical device 50 is loaded into the interior of the delivery device 40 prior to surgery. Inserting the interventional medical device 50 into the interior of the delivery device 40 includes the steps of first passing the free end of the attachment ring 485 through the connection member 1335 of the interventional medical device 50 and onto the connection post 487; then, driving the push rod 42 to The connecting post 487 is moved toward the stop 483 until the connecting post 487 receives the receiving body 489 of the stop 483; then, the interventional medical device 50 is again slowly loaded into the distal end of the outer sheath 43.
- the first method of implantation is performed with the aid of a thoracoscope, which includes the following steps.
- the first step is to sew a squat purse 201 at the right atrial appendage, which includes: first, the patient is placed on the left side of the left side about 30 degrees, and the left side of the fourth intercostal sternum is opened about 3 cm. Ground, in turn cut the skin, subcutaneous tissue and muscular fascia, blunt dissection of the muscle layer to the pleural cavity; secondly, reveal the pericardium; then, cut the happy bag and suspend the pericardium, expose the right atrium; then, at the right atrial appendage A sash purse 201 is sewn.
- the patient may be placed on the left side by an angle of about 30 degrees to 45 degrees depending on individual differences and actual needs of the patient.
- a squat purse can be sewed on the front atrial wall of the right atrium according to individual differences and actual needs of the patient, so that the puncture needle enters the left atrium 4 in the subsequent step. It can be understood that, in other embodiments, according to the individual difference of the patient and the actual needs, in order to facilitate the operation, two or more small incisions other than the incision required for the thoracoscopic can be formed on the right chest, It is limited to a small incision other than the incision required for the thoracoscopic mirror in the present embodiment.
- the needle tip of the puncture needle 202 is sent into the left atrium 4, specifically, the needle tip of the puncture needle 202 is punctured from the middle of the sputum purse 201 into the right atrium 3, and puncture through the interatrial septum 31. Enter the left atrium 4. It can be understood that in other embodiments, the needle tip of the puncture needle 202 can also be punctured into the left atrium 4 via the fossa ovalis 301 according to individual differences and actual needs of the patient.
- the distal end of the guide wire 204 is sent into the left atrium 4 along the lumen of the puncture needle 202, and enters the left ventricle 6 through the mitral valve 2.
- the puncture needle 202 is withdrawn from the heart system.
- the fifth step please refer to FIG. 22 together to measure the size of the mitral annulus 8.
- the distal end of the delivery system 43a carrying the pulsator 207 is sent along the guide wire 204 to the left atrium 4, and secondly, the valvator 207 is released from the delivery system 43a, and the mitral valve is measured. The size of the ring 8 and, finally, the retractor 207 is retracted into the delivery system 43a.
- the delivery system 43a loaded with the valvator 207 is withdrawn from the cardiac system and the appropriate size of the interventional medical device 50 is selected in accordance with the measured size of the mitral annulus 8. It will be appreciated that in other embodiments, if the size of the mitral annulus 8 is measured by ultrasound and/or computed tomography prior to surgery, the fifth and sixth steps may omit.
- the seventh step the distal end of the delivery device 40 carrying the appropriate size of the interventional medical device 50 is transported along the guide wire 204 to the left ventricle 6, tightening the squat pocket 201, and adjusting the bend.
- Unit 474 adjusts the angle of the distal end of outer sheath tube 43 such that the distal end of outer sheath tube 43 is perpendicular to the plane in which mitral annulus 8 is located.
- the guidewire 204 is withdrawn from the heart system.
- the interventional medical device 50 is entirely exposed from the delivery device 40 and is fixed to the mitral valve tissue.
- the second rotating cylinder 472 is rotated, and the rotating second rotating cylinder 472 drives the outer sheath tube 43 to move slowly relative to the push rod 42 toward the proximal end of the conveying device 40, gradually exposing the interventional medical device 50 until the interventional medical device
- the outflow side skirt 134 exposes the outer sheath tube 43;
- the driving member 4742 of the adjusting and bending unit 474 is adjusted, and the driving member 4742 drives the pulling wire 4741 of the adjusting unit 474 to adjust the angle of the distal end of the outer sheath tube 43 so that the mitral valve
- the leaflets 15, 12 are placed within an angle between the outflow side skirt 134 and the stent body 10 (as shown in Figures 24 and 25); then, the second coil 472 is continued to rotate, the second coil 472 being rotated
- the outer sheath tube 43 is driven to move slowly relative to the push rod 42 toward the proximal end of the delivery device 40, the interventional medical device 50 is gradually pushed out of the outer shea
- the mitral annulus 8 is internal to increase the stability of the interventional medical device 50 in the body (as shown in Figures 26 and 27).
- the connecting distal member 1335 on the interventional medical device 50 is connected to the distal end of the push rod 42 via the connecting ring 458.
- the second rotating cylinder 472 can be rotated, and the outer sheath tube 43 is advanced until the interventional medical device 50 is completely collected into the sheath 43, and the interventional medical device 50 is re-introduced from the delivery device 40 after the position is adjusted. All of them are exposed and fixed on the mitral valve tissue.
- the interventional medical device 50 is released from the delivery device 40. Specifically, first, in a state where the outer sheath tube 43 is kept stationary relative to the outer casing 41, the first rotating cylinder 463 is rotated, and the rotating first rotating cylinder 463 drives the first slider 465 and the push rod connected to the first slider 465. 42 moves slowly toward the proximal end relative to the outer casing 41, and the push rod 42 that moves toward the proximal end drives the connecting member 481 away from the stopper 483 to release the binding of the connecting post 487 to the connecting ring 485, thereby the interventional medical device 50 from the conveying device 40. Released (as shown in Figures 28 and 29).
- the inner sheath core 44 is received into the outer sheath tube 43, and the distal end of the outer sheath tube 43 and the proximal end of the outer sheath tube 43 are adjusted to the same straight line.
- the second spinner 472 is rotated, and the rotating second spinner 472 drives the distal end of the outer sheath tube 43 to slowly move toward the distal end of the inner sheath core 44.
- the distal end of the guidewire 204 is again placed into the left atrium 4 along the lumen of the inner sheath 44 in the delivery device 40, the delivery device 40 is withdrawn, and the guidewire 204 is retained. In the left atrium 4 .
- the occlusion device 208 is implanted under the guidance of the guide wire 204 to block the puncture site of the interatrial septum 31 (as shown in FIG. 33); if there is no residual shunt
- the guide wire 204 is withdrawn from the cardiac system, and the purse 201 is ligated, and a small incision of the right chest is sutured to complete the entire surgical procedure.
- the implantation method of the present invention has the following advantages:
- the small chest incision is punctured without the need of a vascular path, and the size of the interventional medical device is not limited by the size of the blood vessel, which is advantageous for the flexibility of the structural design of the interventional medical device;
- the right atrial puncture with a lower blood flow pressure than the left ventricle and a thinner muscle layer, the puncture point does not bleed or the amount of bleeding is small and the puncture is easy;
- the interventional medical device recovery device of the present invention is disposed in the left atrium to avoid the occurrence of obstruction of the left ventricular outflow tract and improve the safety of the operation;
- the delivery device carrying the interventional medical device is far away from the chord, and the delivery device or the interventional medical device is prevented from touching the chordae, thereby reducing the occurrence of the chordae wrapping device or the interventional medical device. Make the surgery safer.
- a second method of implanting a medical device includes the following steps:
- the first step it is the same as the first step in the first implantation method, and will not be described again here.
- the needle tip of the puncture needle 202 is punctured from the middle of the jaw bag 201 into the right atrium 3.
- the distal end of the guide wire 204 is sent to the right atrium 3 along the inner cavity of the puncture needle 202, the puncture needle 202 is withdrawn from the right atrium 3, and the guide wire is retained. 204 is in the right atrium 3.
- the delivery sheath 80 is sent to the right atrium 3 along the guide wire 204, the guide wire 204 is withdrawn from the right atrium 3, and the delivery sheath 80 is retained in the right atrium. 3 inside.
- the delivery sheath 80 includes an associated body segment 801 and a distal segment 803.
- the proximal end of the distal section 803 is coupled to the distal end of the body section 801 and the distal end of the distal section 803 extends toward the distal end of the delivery sheath 80 (ie, the distal end of the distal section 803 faces away from the proximal end of the body section 801 The direction of the extension).
- the extending direction of the distal end section 803 toward the distal end and the extending direction of the distal end of the main body section 801 have an angle of an angle of about 20 degrees to 30 degrees, that is, the delivery sheath 80 has a predetermined 20 degrees. To an angle of 30 degrees.
- the extending direction 803 of the distal end portion to the distal end and the extending direction of the distal end portion of the main body segment 801 have an angle of about 30 degrees.
- the extending direction of the distal end section 803 to the distal end and the extending direction of the distal end of the main body section 801 may have an angle of about 20 degrees, 25 degrees, or 28 degrees. The angle of the.
- the delivery sheath 80 used in the implantation method of the present embodiment has a predetermined angle, and the position of the puncture chamber interval 31 can avoid the puncture needle puncture the posterior wall of the left atrium 4 during the operation, thereby reducing the risk of surgery.
- the distal end of the guide wire 204 is sent to the left ventricle 6.
- the needle tip of the puncture needle or the RF punching needle 90 is sent from the inside of the delivery sheath 80 to the right atrium 3, and the tip of the puncture needle or the RF punching needle 90 is pierced or perforated through the interatrial septum.
- the delivery sheath 80 is withdrawn from the right atrium 3; then, the distal end of the guide wire 204 is sent to the left atrium 4 along the lumen of the puncture needle or radiofrequency perforating needle 90, and The mitral valve 2 enters the left ventricle 6; then, the puncture needle or RF punch needle 90 is withdrawn from the cardiac system and the distal end of the guidewire 204 is retained within the left ventricle 6. As such, the distal end of the guidewire 204 is delivered to the left ventricle 6.
- a third method of implanting an interventional medical device includes the following steps:
- two squat pockets 201, 203 are sewed on the front side wall 32 of the right atrium 3, specifically, including: first, the patient is placed on the left side about 40 degrees, and the right chest is placed on the fourth side of the sternum.
- a small incision of centimeter specifically, incision of the skin, subcutaneous tissue and muscular fascia, blunt separation of the muscle layer to the pleural cavity; secondly, revealing the pericardium; then, cut the happy bag and suspend the pericardium, exposing the right atrium;
- the purse-type purse 201 and the purse-type purse 203 (shown in FIG. 41) are sewn on the right atrium front wall 32.
- two or more small incisions may be formed on the right chest according to individual differences and actual needs of the patient, and are not limited to one small incision in this embodiment.
- the needle tips of the puncture needles 202 and 205 are respectively sent to the left atrium 4, and specifically, the needle tips of the puncture needles 202 and 205 are respectively punctured from the middle of the sputum purse 201 and the middle of the purse 203 into the right atrium 3, and puncture
- the room 31 enters the left atrium 4 (as shown in Figure 42).
- the distal end of the guide wire 204 is sequentially inserted into the left ventricle 6 through the right atrium 3, the interatrial septum 31, the left atrium 4, and the mitral valve 2 along the lumen of the puncture needle 202.
- the lumen of the needle 205 enters the left atrium 4 through the right atrium 3 and the interatrial septum 31 (as shown in Figure 43).
- the surgical aid 73 is delivered to the left atrium 4. Specifically, first, the puncture needles 202 and 205 are withdrawn from the cardiac system (as shown in FIG. 44); secondly, the distal end of the delivery sheath 70 with the dilator 71 is introduced into the left atrium 4 along the guide wire 206, And tightening the enamel purse 203 (as shown in FIG. 45); then, the guide wire 206 and the dilator 71 are withdrawn from the cardiac system; finally, the surgical aid 73 is sent to the left atrium 4 through the delivery sheath 70, To assist with surgery (as shown in Figure 46).
- the surgical aid 73 is an ultrasonic probe. In other embodiments, the surgical aid 73 can also be a surgical robot.
- the distal end of the delivery device 40 carrying the valve device 50 is transported along the guide wire 204 to the left ventricle 6, the squat pocket 201 is tightened, and the outer sheath tube 43 is adjusted under the aid of the surgical aid 73.
- the angle of the distal end of the sheath 43 is made perpendicular to the plane of the mitral valve 2 (as shown in Figure 47).
- the third implanting method may further include a step of measuring the size of the mitral annulus 8 as in the first implantation method between the fourth step and the fifth step to help The steps of intervening medical device 50 are selected.
- the surgical aid 73 when the surgical aid 73 is an ultrasound probe, the distal end of the delivery device 40 carrying the valve instrument 50 in the fourth and fifth steps is transported along the guide wire 204 to the left.
- the ventricles 6 can be performed simultaneously, as long as the distal angle of the outer sheath tube 43 is adjusted, the surgical aid 73 has been delivered to the left atrium 4 and can assist in adjusting the outer sheath tube 43.
- the distal end of the delivery device 40 carrying the valve instrument 50 in the fifth step is also delivered along the guidewire 204 to the left ventricle 6 This can be done before the fourth step, as long as the distal angle of the outer sheath tube 43 is adjusted, the surgical aid 73 has been delivered to the left atrium 4 and can assist in adjusting the outer sheath tube 43.
- the sixth step to the twelfth step are the same as the sixth step to the twelfth step in the first implantation method, and are not described herein again.
- the occlusion device 208 is implanted under the guidance of the guide wire 204 to block the puncture site of the interatrial septum 31 (as shown in FIG. 48); if there is no residual shunt.
- the delivery device 40, the delivery sheath 70 and the surgical aid device 73 are withdrawn from the cardiac system, the purse 201 and the purse 203 are ligated, and the right chest small incision is sutured to complete the entire surgical procedure.
- the above two puncture channels can also be used as a puncture channel. To replace.
- the present invention also provides a fourth method of implanting an interventional medical device 50, which is performed with the aid of a thoracoscope, which includes the following steps:
- a squat purse 201 is sewed in the pre-puncture position 36 of the room ditch, which comprises: first, opening a small incision of about 2.5 cm in the fourth intercostal space of the front front chest line. Specifically, the skin, subcutaneous tissue and myometrial fascia are sequentially cut, the muscle layer is bluntly separated to the pleural cavity; secondly, the pericardium is exposed; then, the pericardium is cut and suspended, and the chamber ditch 310 is exposed; then, The pre-puncture position 36 is determined under the guidance of a thoracoscope and a squat pocket 201 is sewn around the pre-puncture position 36.
- the needle tip of the puncture needle 202 is inserted into the left atrium 4 from the middle of the jaw bag 201.
- the third step to the eleventh step are substantially the same as the steps from the third step to the eleventh step in the first implant method, and are not described herein again.
- the fourth planting into the interventional medical device 50 of the invention does not require extracorporeal circulation, thereby avoiding the hazard of surgical trauma; the small chest incision puncture does not require a transvascular path, and the size of the interventional medical device is not limited by the size of the blood vessel.
- the blood flow pressure is smaller than the left ventricular blood flow pressure, the puncture point will not bleed or the amount of bleeding is small and the puncture is easy; the interventional medical device recovery device is set on the left The atrium avoids the occurrence of obstruction of the left ventricular outflow tract; the delivery device carrying the interventional medical device is far away from the chordae, and the delivery device or the interventional medical device is difficult to touch the chordae, reducing the possibility of the chordae winding device or the interventional medical device.
- the operation process is relatively simple.
- a squat purse can also be sewn on the left atrium wall, and the needle tip of the puncture needle can also be punctured into the left atrium through the squat purse on the left atrium wall.
- the puncture is to be punctured.
- the other steps of the implantation method can also adopt the third step to the twelfth step of the fourth implantation method.
- the implantation method of the present invention can be used not only for implantation of a prosthetic mitral valve, but also with a slight modification to complete tricuspid valve replacement, mitral annulus repair, left atrial appendage closure, heart Surgery and other operations.
- a further embodiment of the present invention provides a prosthetic heart valve stent 10a, which includes a tubular stent body 11a, an inflow side skirt 133a disposed on an outer wall of the stent body 11a, and an outflow disposed on the outer wall of the stent body 11a.
- the side skirt 134a and the choke cloth 135a provided on the outflow side skirt 134a.
- the free ends of the inflow side skirt 133a and the outflow side skirt 134a both extend toward the inflow side end portion 111a side of the holder main body 11a.
- the inflow side skirt 133a is configured to cooperate with the outflow side skirt 134a to hold the prosthetic heart valve tissue.
- the distance between the end portion of the inflow side skirt 134a connected to the bracket main body 11a and the end portion of the outflow side skirt 134a connected to the bracket main body 11a ranges from 2 to 6 mm.
- the inflow side skirt 133a and the outflow side skirt 134a are both disposed on the bracket body 11a by knitting, and the choke cloth 135a is only disposed on the outflow side skirt 134a; the inflow side skirt 134a and the bracket
- the distance between the end portion where the main body 11a is connected and the end portion of the outflow side skirt 134a which is connected to the holder main body 11a is 2 mm.
- the inflow side skirt 133a is provided on the inflow side end portion 111a of the bracket main body 11a, and includes a plurality of first skirt sub-units 1332a which are separated from each other.
- Each of the first skirt sub-units 1331a is woven and shaped by a nickel-titanium wire, and is disposed on the bracket main body 11a by a knitting method.
- Each of the first skirt sub-units 1332a includes an inflow-side gripper sub-unit 1331a and an inflow-side scooping sub-unit 1333a.
- the inflow-side grip portion sub-unit 1331a is located between the inflow-side lift-up portion sub-unit 1333a and the holder main body 11a.
- Each of the inflow side grip portion sub-units 1331a is substantially parallel to a cross section of the holder main body 11a perpendicular to its longitudinal center line.
- Each of the inflow side lifter sub-units 1333a is substantially parallel to the longitudinal centerline of the stent body 11a.
- the plurality of inflow-side gripping unit sub-units 1331a collectively constitute an inflow-side gripping portion of the inflow-side skirt portion 133a
- the plurality of inflow-side tilting-portion sub-units 1333a collectively constitute an inflow-side tilting portion of the inflow-side skirt 133a.
- At least one first skirt sub-unit 1332a of the inflow side skirt 133a can also be connected by welding to other parts of the bracket body 11a except for the inflow side end portion 111a according to actual needs. It can also be understood that the inflow side skirt 133a can also be provided with an inflow side anchor with a free end facing the outflow side end 113a side; the inflow side skirt 133a can also be provided with a connecting element that can be detachably connected to the transport system. .
- the outflow side skirt 134a includes a plurality of second skirt sub-units 1342a that are separated from one another.
- the number of the second skirt sub-units 1342a is equal to the number of the first skirt sub-units 1332a, and the plurality of second skirt sub-units 1342a and the plurality of first skirt sub-units 1332a one-to-one correspondence.
- Each of the second skirt sub-units 1342a is woven and shaped by a nickel-titanium wire, and is disposed on the bracket main body 11a by a knitting method.
- Each of the second skirt sub-units 1342a includes an outflow-side gripper sub-unit 1341a and an outflow-side scooping sub-unit 1343a.
- the outflow side grip portion sub-unit 1341a is located between the outflow side lift portion sub-unit 1343a and the holder main body 11a.
- Each of the outflow side grip portion sub-units 1341a has an angle with a longitudinal center line of the holder main body 11a.
- each of the outflow-side clamping portion sub-unit 1341a and the longitudinal center line of the bracket main body 11a has an angle of fifty degrees; each of the outflow-side clamping portion sub-units 1341a and the corresponding inflow-side clamp The distance between the holding portion sub-units 1331a along the longitudinal center axis of the holder main body 11a gradually decreases outward from the holder main body 11a.
- Each of the outflow side lifter sub-units 1343a is substantially parallel to the longitudinal centerline of the stent body 11a.
- the plurality of outflow side gripping portion subunits 1341a collectively constitute an outflow side gripping portion of the outflow side skirt 134a
- the plurality of outflow side tilting section subunits 1343a collectively constitute an outflow side tilting portion of the outflow side skirt 134a.
- Each of the second skirt sub-units 1342a further includes a grid 1345a formed by a plurality of braided lines intersecting to facilitate better placement of the baffle cloth 135a. It will be appreciated that the outflow side anchors may also be provided on the grid of the grid 1345a.
- At least one of the second skirt sub-units 1342a in the outflow side skirt 134a can also be disposed on the bracket body 11a by welding. It will also be appreciated that the outflow side skirt 134a may also be replaced by the outflow side skirt 134 in the first embodiment. It will also be appreciated that the inflow side skirt 133a may also be replaced by the inflow side skirt 133 in the first embodiment.
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Abstract
一种心脏瓣膜支架(10),其包括具有相对的流入侧端部(111)及流出侧端部(113)的管状支架主体(11)、围绕所述支架主体(11)外壁的流入侧裙边(133)及围绕所述支架主体(11)外壁的流出侧裙边(134),在展开状态下,所述流入侧裙(133)边及所述流出侧裙边(134)的自由端均朝所述流入侧端部(111)侧延伸,所述流入侧裙边(133)用于与流出侧裙边(134)配合夹持心脏瓣膜组织。所述人工心脏瓣膜支架(10)可以稳固地设置于心脏瓣膜组织上,延长了人工心脏瓣膜的使用寿命,降低了患者再次置换瓣膜的风险。
Description
【技术领域】
本发明涉及介入医疗器械领域,尤其涉及一种人工心脏瓣膜支架、具有该人工瓣膜支架的人工心脏瓣膜及该人工心脏瓣膜的植入方法。
【背景技术】
心脏瓣膜生长在心房和心室之间、心室和大动脉之间,起到单向阀门的作用,帮助血流单方向运动。人体的四个瓣膜分别称为二尖瓣、三尖瓣、主动脉瓣和肺动脉瓣。这些瓣膜如果出现了病变,就会影响血流的运动,从而造成心脏功能异常,最终导致心功能衰竭。
瓣膜病变的类型通常是狭窄或者关闭不全。狭窄指瓣膜张开的幅度不够,造成进入下一个心腔的血液减少;关闭不全指瓣膜关的不严,造成部分血液返流。一旦出现狭窄和/或关闭不全,便会妨碍正常的血液流动,增加相应的心脏负担,从而引起心脏正常功能损害,导致心力衰竭和机体多脏器机能的改变。
目前心脏瓣膜病的外科手术治疗主要分两种方法:1)瓣膜成形术,即对损害的瓣膜进行修理;2)瓣膜置换术,用人工机械瓣或生物瓣进行替换。
瓣膜成形术通常用于病变轻微的二尖瓣或三尖瓣,而对于严重的心脏瓣膜病变,特别是风湿性心脏瓣膜病,多选择瓣膜置换术。瓣膜成形术的主要方法如Key氏成形、DeVega成形以及利用C型环成形等方式。瓣膜置换术系采用人工瓣膜对人病变心脏瓣膜进行置换,如机械瓣、生物瓣等。机械瓣寿命长,但需要终生服药抗凝,容易产生并发症,而生物瓣不需终生抗凝,却寿命短。
近年来,对于尖瓣狭窄和反流的患者也可以行经皮经鞘管的尖瓣瓣膜置换术,即通过介入、微创的方法进行此项手术,让患者避免了开胸手术之苦。
人体心脏右心系统(如图1所示)包括右心房3及右心室5;人体心脏左心系统包括左心房4、左心室6、位于左心房4和左心室6之间的二尖瓣环8、二尖瓣前瓣叶15、二尖瓣后瓣叶12、以及腱索16。现有技术中的人工瓣膜装置包括前瓣叶锚定件及后瓣叶锚定件。前瓣叶锚定件和后瓣叶锚定件分别固定于二尖瓣前瓣叶15和二尖瓣后瓣叶12上以防止人工瓣膜装置在血流的冲击下脱落到左心房4。然瓣叶组织比较脆弱,故,前瓣叶锚定件4和后瓣叶锚定件3不仅易损伤瓣叶,且易从瓣叶上面脱落,从而直接导致人工心脏瓣膜在心脏瓣膜组织上的稳定性较差,影响了人工心脏瓣膜的使用寿命,增加了患者再次置换瓣膜的风险。
【发明内容】
基于此,有必要提供一种人工心脏瓣膜支架、一种具有该人工心脏瓣膜支架的人工心脏瓣膜及该人工心脏瓣膜的植入方法,该人工心脏瓣膜支架可以稳固地设置于心脏瓣膜组织上,延长了人工心脏瓣膜的使用寿命,降低了患者再次置换瓣膜的风险。
本发明提供一种人工心脏瓣膜支架,其包括具有相对的流入侧端部及流出侧端部的管状支架主体、围绕所述支架主体外壁的流入侧裙边及围绕所述支架主体外壁的流出侧裙边。在展开状态下,所述流入侧裙边及所述流出侧裙边的自由端均朝所述流入侧端部侧延伸,所述流入侧裙边用于与流出侧裙边配合夹持心脏瓣膜组织。
在其中一个实施例中,所述人工心脏瓣膜支架还包括围绕所述支架主体外壁的管状连接支架,所述流入侧裙边及流入侧裙边分别位于所述管状连接支架的两端。
在其中一个实施例中,所述管状连接支架与所述主体支架分别单独成型再固定连接为一体。
在其中一个实施例中,所述流入侧裙边的与所述管状支架主体相连的端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影,与所述流入侧端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影相分离。
在其中一个实施例中,所述流入侧裙边的与所述管状支架主体相连的端部与所述流入侧端部之间的距离,大于或等于所述流出侧裙边的与所述管状支架主体相连的端部与所述流出侧端部之间的距离。
在其中一个实施例中,所述流出侧裙边的与所述管状支架主体相连的端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影,与所述流出侧端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影相分离。
在其中一个实施例中,所述流入侧裙边包括与所述支架主体相连的流入侧夹持部、及与所述流入侧夹持部相连的流入侧翘起部,所述流入侧夹持部位于所述流入侧翘起部与所述支架主体之间,所述流入侧翘起部远离所述流入侧夹持部的端部为所述流入侧裙边的自由端,且所述流入侧翘起部与所述流入侧夹持部之间具有夹角。
在其中一个实施例中,所述流入侧翘起部包括围绕所述支架主体的流入侧波形结构。
在其中一个实施例中,所述流出侧裙边包括与所述支架主体相连的流出侧夹持部、及与所述流出侧夹持部相连的流出侧翘起部,所述流出侧夹持部位于所述流出侧翘起部与所述支架主体之间,所述流出侧翘起部远离所述流出侧夹持部的端部为所述流出侧裙边的自由端,且所述流出侧翘起部与所述流出侧夹持部之间具有夹角。
在其中一个实施例中,所述流入侧裙边包括多个相互分离的第一裙边子单元,每个所述第一裙边子单元均通过编织的方法设于所述支架主体上。
在其中一个实施例中,所述流入侧裙边上设有多个流入侧锚定件,所述流入侧裙边上的流入侧锚定件的自由端朝所述流出侧端部侧延伸。
在其中一个实施例中,所述流入侧裙边的与所述管状支架主体相连的端部和所述流出侧裙边的与所述管状支架主体相连的端部之间的距离范围为2至6毫米。
在其中一个实施例中,所述流入侧裙边的自由端上设有多个连接元件。
在其中一个实施例中,所述流入侧裙边与流出侧裙边中至少一个裙边上覆盖有阻流布。
本发明还提供一种人工心脏瓣膜,其包括上述的人工心脏瓣膜支架和瓣叶,所述瓣叶设于所述管状支架主体内部。
本发明还提供一种介入医疗器械的植入方法,其包括:在右胸上形成小切口露出心房,及将上述的人工心脏瓣膜经所述小切口送至心脏系统的植入位置,并固定于心脏系统的组织上。
在其中一个实施例中,所述心脏瓣膜为人工二尖瓣瓣膜,在右胸上形成小切口露出心房步骤之后,将所述的心脏瓣膜经所述小切口送至心脏系统的植入位置步骤之前,所述植入方法还包括将导丝经所述小切口送至左心室的步骤。
在其中一个实施例中,将所述导丝经所述小切口送至左心室包括步骤:在心房壁上缝一个褥式荷包;将穿刺针的针尖经所述褥式荷包送入左心房;及将导丝的远端沿着所述穿刺针内腔送入左心房,并经过二尖瓣进入左心室。
在其中一个实施例中,将所述导丝经所述小切口送至左心室包括步骤:在右心房壁上缝一个褥式荷包;将射频打孔针的针尖经所述褥式荷包、右心房及房间隔送至左心房;及将所述导丝的远端沿着所述射频打孔针内腔送入左心房,并经过二尖瓣进入左心室。
在其中一个实施例中,将所述导丝经所述小切口送至左心室包括步骤:在房间沟的预穿刺位置周围缝一个褥式荷包;将穿刺针的针尖经所述褥式荷包送入左心房;及将所述导丝的远端沿着所述穿刺针内腔送入左心房,并经过二尖瓣进入左心室。
与现有技术比较,本发明人工心脏瓣膜支架的流入侧裙边与流出侧裙边配合夹持心脏瓣膜组织,使得人工心脏瓣膜支架可以稳固地设置于心脏瓣膜组织上,延长了具有该人工心脏瓣膜支架的人工心脏瓣膜的使用寿命,降低了患者再次置换瓣膜的风险。与现有技术相比,本发明的植入方法至少具有以下优点:(1)本发明的手术操作过程中,无需体外循环,避免了外科手术创伤大的危害;(2)本发明的手术操作过程中,经右胸小切口穿刺,无需经血管路径,介入医疗器械尺寸不受血管尺寸大小的限制,有利于介入医疗器械结构设计的灵活性;(3)本发明的手术操作过程中,经血流压力较左心室血流压力小且肌层较薄的右心房穿刺,穿刺点不会出血或者出血量较少且穿刺容易;(4)本发明的介入医疗器械回收装置设置在左心房,避免左室流出道梗阻的发生,提高手术的安全性;(5)本发明的手术操作过程中,承载介入医疗器械的输送装置距离腱索较远,避免输送装置或介入医疗器械碰触腱索,减少了腱索缠绕输送装置或者介入医疗器械的发生,使手术更安全。
【附图说明】
图1是人体心脏系统示意图;
图2是本发明第一实施例提供的介入医疗器械置换系统的示意图;
图3是图2中的介入医疗器械置换系统的输送装置的示意图;
图4是图3沿IV-IV线的剖视图;
图5是图3中P处放大图;
图6是图2中的输送装置的推杆驱动组件的部分结构示意图;
图7是图3中Q处的放大图;
图8是图2中的输送装置的鞘管驱动组件的部分结构示意图;
图9是图3中M处的放大图;
图10是图2中的输送装置的连接组件中的止挡件与连接件相连时的状态示意图;
图11是图2中的输送装置与介入医疗器械相连的示意图;
图12是图2中的介入医疗器械的结构示意图;
图13是图13中的介入医疗器械的支架的示意图;
图14是图12中介入医疗器械的支架去除阻流膜后的示意图;
图15是图14中支架的支架主体的结构示意图;
图16是图14中的瓣环密封件去除阻流膜后的示意图;
图17是图16中N处的放大图;
图18是图16从流出侧裙边侧看去的俯视图。
图19是在右心耳处设置荷包后的示意图;
图20是穿刺针经图19的荷包进入左心房后的示意图;
图21是导丝经图20中的穿刺针的内腔到达左心室后的示意图;
图22是测量瓣环尺寸的示意图;
图23是装载有介入医疗器械的输送装置沿导丝到达二尖瓣后的示意图;
图24是心脏系统中的介入医疗器械部分从输送装置中露出后的示意图;
图25是部分露出的介入医疗器械与输送装置之间的位置关系示意图;
图26是心脏系统中的介入医疗器械全部从输送装置中露出后的示意图;
图27是全部露出的介入医疗器械与输送装置之间的位置关系示意图;
图28是心脏系统中的释放后的介入医疗器械的示意图;
图29是介入医疗器械与输送装置完全分离后的示意图;
图30是输送装置的内鞘芯与外鞘管合拢后的示意图;
图31是心脏系统中内鞘芯与外鞘管合拢后的示意图;
图32是导丝经输送装置进入左心房后的示意图;
图33是设置封堵器封堵房间隔穿刺孔及结扎荷包后的示意图;
图34是第二种植入方法中穿刺针经荷包进入右心房后的示意图;
图35是将导丝的远端沿图34的穿刺针内腔送至右心房后的示意图;
图36是将图35中的穿刺针从右心房撤出后的示意图;
图37是沿图36中的导丝将输送鞘管的远端送至右心房后的示意图;
图38是将图37中的导丝从右心房中撤出后的示意图;
图39是经图38中的输送鞘管的内腔将穿刺针或者射频打孔针的远端经房间隔送至左心房后的示意图;
图40是经图39中的穿刺针或者射频打孔针的内腔将导丝的远端送至左心室后的示意图;
图41是第三种植入方法中在右心房前侧壁上设置两个荷包后的示意图;
图42是两根穿刺针分别经图41的两个荷包进入左心房后的示意图;
图43是两根导丝分别经图42中的两根穿刺针的内腔进入左心房后的示意图;
图44是穿刺针从心脏系统撤出后的示意图;
图45是带有扩张器的输送鞘管的远端经导丝进入左心房后的示意图;
图46是手术辅助装置经输送鞘管送至左心房后的示意图;
图47是装载有介入医疗器械的输送装置的远端经另外一个导丝到达二尖瓣后的示意图;
图48是设置封堵器封堵两个房间隔穿刺孔及结扎两个荷包后的示意图;
图49是第四种植入方法中在房间沟上的预穿刺位置的示意图;
图50是在图49中的预穿刺位置周围设置荷包后的示意图;
图51是穿刺针经图50的荷包进入左心房后的示意图;
图52是经房间沟植入介入医疗器械后的示意图;
图53是本发明又一实施例提供的介入医疗器械的支架的示意图;
图54是将图53中的支架的流出侧裙边及阻流布去除之后的示意图;
图55是图54的俯视图;
图56是将图53中的支架的流入侧裙边及阻流布去除之后的示意图;
图57是图56的俯视图。
【具体实施方式】
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。
需要说明的是,当元件被称为“固定于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。在介入领域,通常将相对操作者近的一端称为近端,相对操作者远的一端称为远端。
还需要说明的是,本发明的介入医疗器械的植入方法以植入二尖瓣的人工心脏瓣膜为例进行说明,而本发明的构思还可以用在植入左心耳封堵器、房间隔缺损封堵器等介入医疗器械。还需要说明的是,本发明所涉及的心脏瓣膜组织是指瓣环、瓣叶、腱索、乳头肌等心脏组织中的一种或者几种组织的组合。在输送状态下,人工心脏瓣膜收缩于输送装置中,便于输送;在展开状态下,人工心脏瓣膜从输送装置中脱离,径向膨胀后与心脏组织贴合固定为一体。
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
请参阅图2,本发明第一实施例提供的介入医疗器械置换系统100包括输送装置40、介入医疗器械50以及装载器(图中未示出)。使用装载器将介入医疗器械50装载于输送装置40上,并使用输送装置40将介入医疗器械50运送至心脏系统的植入位置,完成介入医疗器械50的植入。本实施例中,介入医疗器械50为人工二尖瓣瓣膜;输送装置40将介入医疗器械50植入心脏系统的二尖瓣2上。
输送装置
请参阅图3,输送装置40包括操作手柄41、推杆42、外鞘管43、内鞘芯44及器械连接组件48。
操作手柄41包括手柄外壳45、推杆驱动组件46及鞘管驱动组件47。
请一并参阅图4,手柄外壳45包含上壳451和具有外径不同于上壳451外径的下壳453。上壳451与下壳453组装后为偏心结构。优选地,本事实例中,上壳451的外径小于推杆驱动组件46及鞘管驱动组件47中具有较小外径的组件的外径,下壳453的外径大于推杆驱动组件46及鞘管驱动组件47中具有较大外径的组件的外径。如此,不仅能够使推杆驱动组件46及鞘管驱动组件47部分位于外壳45内,又能够使推杆驱动组件46及鞘管驱动组件47部分位于外壳45外部,便于操作者在外壳45外部操作推杆驱动组件46及鞘管驱动组件47。
上壳451设有与外壳45内腔相连通的第一收容孔455及第二收容孔457(见图3)。第一收容孔455在包括外壳45纵向中心轴线的截面上的形状为T型,且第一收容孔455的靠近外壳45内腔的端部的外径大于第一收容孔455的靠近外壳45外部的端部的外径;推杆驱动组件46部分收容于外壳45内部及第一收容孔455中,且部分从第一收容孔455露出。第二收容孔457在包括外壳45纵向中心轴线的截面上的形状为T型,且第二收容孔457的靠近外壳45内腔的端部的外径大于第二收容孔457的靠近外壳45外部的端部的外径;鞘管驱动组件47部分收容于外壳45内部及第二收容孔457中,且部分从第二收容孔457露出。
下壳453的部分内壁向壳外凹陷形成空间上与第一收容孔455相对应的第一收容槽458及空间上与第二收容孔457相对应的第二收容槽459。第一收容槽458在包括外壳45纵向中心轴线的截面上的的形状为T型,且第一收容槽458槽口处的外径大于第一收容槽458的槽底处的外径。第一收容槽458在包括外壳45纵向中心轴线的截面上的的形状为T型,且第一收容槽458槽口处的外径大于第一收容槽458的槽底处的外径。
请一并参阅图5及图6,推杆驱动组件46包括第一支撑管461、环绕第一支撑管461的第一旋筒463、及收容于第一支撑管461内且可沿第一支撑管461的纵向中心轴移动的中空的第一滑块465。
第一支撑管461收容于第一收容孔455及第一收容槽458围合形成的空间中,且固定于外壳45的内壁上。
第一支撑管461两端的侧壁沿第一支撑管461的周向开设有一个环绕第一支撑管461的纵向中心线的第一环形槽462。第一支撑管461的侧壁沿着第一支撑管461的长度方向开设有两个相对的呈狭长框状且位于两个第一环形槽462之间的第一引导孔464。
第一旋筒463环绕第一支撑管461,且其一端可动地收容于一个第一环形槽462中,另一端可动地收容于另一个第一环形槽462中。第一旋筒463内壁上设有内螺纹466。
优选地,本实施例中,第一旋筒463两端的内径小于第一旋筒463其他部分的内径,如此,第一旋筒463的端部可以收容于第一环形槽462中,且第一旋筒463的中间部分可以与第一支撑管461相分离;第一旋筒463包括相对且相连的两个半壳467(如图4所示)。将第一旋筒463组装于第一支撑管461过程中,可先将一个半壳467的两端分别置于两个第一环形槽462中,再将另一个半壳467的两端分别置于两个第一环形槽462中,且分别与已经置入第一环形槽462中的半壳467的两端卡合连接为一体。
第一滑块465收容于第一支撑管461中,且第一滑块465的相对两侧分别凸出两个第一引导孔464。第一滑块465与第一旋筒463螺纹相连。旋转的第一旋筒463带动第一滑块465沿第一引导孔464轴向移动。第一滑块465的远端与推杆42相连,从而使得第一滑块465的轴向移动可带动推杆42轴向移动。
优选地,本实施例中,第一滑块465为T型结构,第一滑块465的近端外径大于其远端外径,且其近端收容于第一支撑管461内,远端凸出第一支撑管461。第一滑块465设有一个贯穿其近端端面及远端端面的T型轴向通孔468。轴向通孔468的远端外径大于轴向通孔468的近端外径,且轴向通孔468远端外径略大于推杆42的外径,以便于推杆42可以收容于轴向通孔468中。
第一滑块465包括靠近其近端的旋筒连接部469。本实施例中,旋筒连接部469大致为长方体结构,其相对的平行的侧壁分别与第一支撑管461相对的内壁接触,其另一对平行的侧壁分别设置有与内螺纹466配合使用的齿牙4691。
请一并参阅图7及图8,鞘管驱动组件47包括第二支撑管471、环绕第二支撑管471的第二旋筒472、收容于第二支撑管471内且可沿第二支撑管471的纵向中心轴移动的中空的第二滑块473、及调弯单元474。
第二支撑管471收容于第二收容孔457及第二收容槽459围合形成的空间中,且固定于外壳45的内壁上。第二支撑管471的两端的侧壁沿第二支撑管471的周向均开设有一个环绕第二支撑管471的纵向中心线的第二环形槽475。第二支撑管471的侧壁沿着第二支撑管471的长度方向开设有两个相对的呈狭长框状且位于两个第二环形槽475之间的第二引导孔476。
第二旋筒472环绕第二支撑管471,且其一端可动地收容于一个第二环形槽475中,另一端可动地收容于另一个第二环形槽475中。优选地,本实施例中,第二旋筒472的结构与第一旋筒463的结构相同,第二旋筒472也包括内螺纹477;第二旋筒472的尺寸与第一旋筒463的尺寸也相同,在此不再赘述。可以理解的是,其他实施方式中,第二旋筒472的尺寸与第一旋筒463的尺寸也可以不相同,根据实际需要来设定。
第二滑块473收容于第二支撑管471中,且第二滑块473的相对两侧分别凸出两个第二引导孔476。第二滑块473与第二旋筒472螺纹相连。旋转的第二旋筒472带动第二滑块473沿第二引导孔476轴向移动。第二滑块473的远端与外鞘管43的近端相连,从而使得第二滑块473的轴向移动可带动外鞘管43轴向移动。
第二滑块473还设有一个贯穿其近端端面及远端端面的轴向通孔478。轴向通孔478的孔径大于推杆42的外径,以便于推杆42的近端可穿过鞘管驱动组件47与第一滑块465相连,且推杆42可以相对第二支撑管471沿第二支撑管471的轴向移动。
第二滑块473包括靠近其近端的旋筒连接部479。本实施例中,旋筒连接部479大致为长方体结构,其相对的平行的侧壁分别与第二支撑管471相对的内壁接触,其另一对平行的侧壁均设置有与内螺纹477配合使用的齿牙4791。
调弯单元474用于调节外鞘管43远端的角度,其包括与外鞘管43远端相连的牵引丝4741及带动牵引丝4741移动的驱动件4742。驱动件4742的近端与牵引丝4741的远端相连,远端凸出外壳45,便于操作者操作驱动件4742带动牵引丝4741移动,进行对外鞘管43的远端进行调弯。可以理解的是,驱动件4742的结构和原理可以与推杆驱动组件46的结构和原理相同,此时,驱动件4742的滑块与牵引丝4741相连,驱动件4742的滑块在旋筒的带动下带动牵引丝4741移动即可实现本发明的目的,在此不再赘述。
推杆42收容于外鞘管42中,且环绕内鞘芯44。推杆42的近端与推杆驱动组件46相连,推杆42的远端穿出外壳411且向输送装置40的远端延伸。旋转第一旋筒463即可驱动第一滑块465带动推杆42相对外壳411轴向移动。
外鞘管43环绕推杆42,且其近端与鞘管驱动组件47相连,其远端穿出外壳411且向输送装置40的远端延伸。旋转第二旋筒472即可驱动第二滑块473带动外鞘管43相对外壳411轴向移动。
内鞘芯44收容于推杆42内,且其近端依次穿过鞘管驱动组件47、推杆驱动组件46,并于外壳411相连。内鞘芯44的远端穿出外壳411,且较推杆42的远端远离操作手柄41。
请一并参阅图9及图10,器械连接组件48包括设于推杆42远端的连接件481及设于内鞘芯44的止挡件483。连接件481与止挡件483相配合来控制医疗器械50与输送装置40之间的连接与释放。
连接件481包括多个连接环485及多个连接柱487。每个连接环485的一端均连接于推杆42上,另一端为自由端。每个连接柱487的一端均连接于推杆42上,另一端为自由端,且每个连接柱487的自由端均朝上止挡件483。优选地,本实施例中,每个连接环485非自由端及连接柱487的非自由端均连接于推杆42远端端面;连接柱487的个数等于连接环485的个数,且多个连接环485与多个连接柱487一一对应。每个连接环485均邻近于相应的连接柱487。
请一并参阅图11,止挡件483设于内鞘芯44的远端,且较连接件481靠近输送装置40的远端。止挡件483设有多个收容体489,以收容套有连接环485的连接柱487。如此,待连接环485的自由端穿过介入医疗器械50后,连接环485的自由端套于连接柱487上;待套有连接环485的连接柱487收容于收容体489中后,连接环485在无外力作用下将无法从连接柱487上脱离,进而将介入医疗器械50与输送装置40相连;待套有连接环485的连接柱487在外力作用下与收容体489分离后,介入医疗器械50与输送装置40相分离,完成介入医疗器械50的释放。
本实施例中,止挡件483环绕内鞘芯44,且固设于内鞘芯44的外壁;收容体489为贯穿止挡件483近端及远端的通孔;收容体489的个数与连接柱487的个数相等,且多个收容体489与多个连接柱487一一对应,每个收容体489的孔径均大于或者等于相应的连接柱487的外径,以便于一个连接柱487可以收容于相应的收容体489中。
本发明中采用连接环485连接介入医疗器械50与输送装置,连接环485为软性结构,不易造成人体组织损伤,且结构简单,容易制作。
介入医疗器械
请参阅图12及图13,本发明第一实施例提供的介入医疗器械50用于置换病变的二尖瓣瓣膜,其包括人工心脏瓣膜支架10及设于人工心脏瓣膜支架10内的人工瓣叶30。
人工心脏瓣膜支架10包括管状支架主体11及围绕在支架主体外壁的瓣环密封件13。本实施例中,支架主体11与瓣环密封件13分别单独成型后再固接为一体,提高人工心脏瓣膜支架10整体强度,延长了介入医疗器械50的寿命。
管状支架主体11是由丝编织或者管材切割且定型后而形成的网状结构,用于承载人工瓣叶30。优选地,本实施例中,管状支架主体11为采用镍钛金属管材切割且定型而成的网状结构。可以理解的是,其他实施例中,还可以采用镍钛丝编织且定型后形成支架主体,也可以采用由高分子材料制成的高分子丝(例如:聚碳酸酯丝、聚丙烯丝、聚酰胺丝)编织或者由高分子材料制成的高分子管材切割且定型后形成支架主体。
请一并参阅图14及图15,支架主体11包括相对的流入侧端部111及流出侧端部113。支架主体11的花纹上设置有多个焊点115。多个焊点115沿支架主体11的同一周向上均匀间隔分布,多个焊点115的连线与支架主体11的中轴线同轴,用于与瓣环密封件13焊接。本实施例中,焊点115的轮廓线为多边形,且该多边形的内切圆直径大小为0.5mm~2mm,至少大于焊接熔池直径。本实施例中,焊点115中心和流入侧端部111之间的距离,大于焊点115中心和流出侧端部113之间的距离。
请再次参阅图13及图14,瓣环密封件13包括用于连接支架主体11的中空的管状连接支架131、与管状连接支架131的一端相连且向外延伸的流入侧裙边133、与管状连接支架131的另一端相连且向外延伸的流出侧裙边134、及阻流布135。其中,连接支架131是由丝编织或者管材切割且定型后而形成的网状结构。优选地,本实施例中,连接支架131为采用镍钛金属管材切割且定型而成的网状结构;流入侧裙边133、流出侧裙边134及管状连接支架131一体成型。可以理解的是,其他实施例中,还可以采用镍钛丝编织且定型后形成连接支架,也可以采用由高分子材料制成的高分子丝(例如:聚碳酸酯丝、聚丙烯丝、聚酰胺丝)编织或者由高分子材料制成的高分子管材切割且定型后形成连接支架。
流入侧裙边133及流出侧裙边134的自由端均朝流入侧端部111侧延伸。流入侧裙边133用于与流出侧裙边134配合夹持人工心脏瓣膜组织。流入侧裙边133的与支架主体11相连的端部与流出侧裙边134的与支架主体11相连的端部之间的距离范围为2至6毫米。阻流布135设于流入侧裙边133及流出侧裙边134的至少一个裙边上,用于阻止血流在瓣环密封件13处的返流,防止出现瓣周漏。优选地,本实施例中,流入侧裙边133与流出侧裙边134配合夹持的心脏瓣膜组织为瓣环8、瓣叶15及瓣叶12;阻流布135设于流入侧裙边133朝向流出侧端部113的表面、连接支架131的位于流入侧裙边133与流出侧裙边134之间的外壁、及流出侧裙边134朝向流入侧端部111的表面上。在其他一些实施例中,阻流布135可仅设于流入侧裙边133或者流出侧裙边134上。
请一并参阅图16,连接支架131设置有多个焊点1311。焊点1311和支架主体11上的焊点115进行配合焊接,焊点1311的形状和大小分别与焊点115的形状及大小相同,焊接可采用激光电焊或电阻焊。
请一并参阅图17及图18,流入侧裙边133围绕管状连接支架131,其包括与连接支架131相连且围绕所述连接支架131的流入侧夹持部1331、及与流入侧夹持部1331相连且围绕流入侧夹持部1331的流入侧翘起部1333。流入侧夹持部1331位于流入侧翘起部1333与连接支架131之间。优选地,本实施例中,待瓣环密封件13连接于主体支架11上时,流入侧裙边133的与管状支架主体11相连的端部在平行于管状支架主体11的纵向中心轴线的截面上的投影,与流入侧端部111在平行于管状支架主体11的纵向中心轴线的截面上的投影相分离,也就是说,流入侧裙边133连接在支架主体11除流入侧端部111的其他根据实际需要的部位。可以理解的是,流入侧裙边133也可以连接在支架主体11的流入侧端部111。
流入侧夹持部1331连接于连接支架131与流入侧翘起部1333之间,其自连接支架131的外壁朝外延伸形成。本实施例中,流入侧夹持部1331在展开状态下大致平行于垂直于连接支架131纵向中心轴的截面;流入侧夹持部1331包括多个菱形网格1334。多个菱形网格1334的中心相连形成一个围绕连接支架131的环形结构。
流入侧翘起部1333由流入侧夹持部1331的外缘朝靠近流入侧端部111侧的方向延伸形成。流入侧翘起部1333远离流入侧夹持部1331的端部即为流入侧裙边133的自由端,且在展开状态下的流入侧翘起部1333与流入侧夹持部1331之间具有夹角。由此流入侧裙边133在器械介入医疗器械内后承载于二尖瓣瓣环6上,避免流入侧裙边133的边缘对左心房切割。本实施例中,在展开状态下,流入侧翘起部1333与流入侧夹持部1331之间的夹角的度数为九十度。可以理解的是,在展开状态下的流入侧翘起部1333与流入侧夹持部1331之间的夹角的度数也可以为三十度、六十度或者一百二十度等根据需要所设定的度数,不限于本实施例中的九十度。
在流入侧翘起部1333的向流入侧端部111侧延伸的边缘上还设有多个用于连接输送系统(图未示)的连接元件1335。优选地,本实施例中,流入侧翘起部1333的自由端的边缘形成围绕连接支架131的流入侧波形结构,连接元件1335为连接孔,且位于流入侧波形结构的波峰上。可以理解的是,连接元件1335也可以为连接钩。
可以理解的是,流入侧裙边133上还设置有多个自由端朝向左心室侧(也就是流出侧端部113侧)的流入侧锚定件。还可以理解的是,流入侧锚定件也可以设于流入侧翘起部1333上,可以根据实际需要来设定。
请再次参阅图13、图14及图16,流出侧裙边134围绕管状连接支架131,包括与连接支架131相连且围绕所述连接支架131的流出侧夹持部1341、及与流出侧夹持部1341相连且围绕流出侧夹持部1341的流出侧翘起部1343。流出侧夹持部1341位于流出侧翘起部1343与连接支架131之间。
优选地,本实施例中,流出侧裙边134的与支架主体11相连的端部在平行于支架主体11的纵向中心轴线的截面上的投影,与流出侧端部133在平行于支架主体11的纵向中心轴线的截面上的投影相分离,且流出侧裙边134的与支架主体11相连的端部与流出侧端部113之间的距离,小于流入侧裙边133的与支架主体11相连的端部与流入侧端部111之间的距离,以降低流出道梗阻的风险。
可以理解的是,流出侧裙边134也可以连接在支架主体11的流出侧端部113。还可以理解的是,流出侧裙边134的与支架主体11相连的端部与流出侧端部113之间的距离,也可以等于流入侧裙边133的与支架主体11相连的端部与流入侧端部111之间的距离。
流出侧夹持部1341连接于连接支架131与流出侧翘起部1343之间,其自连接支架131的外壁朝外延伸形成。流出侧夹持部1341的与连接支架131相连的端部与流入侧夹持部1331的与连接支架131相连的端部之间的距离范围为2至6毫米。
本实施例中,在展开状态下,流出侧夹持部1341与连接支架131纵向中心轴之间形成锐角;流出侧夹持部1341的与连接支架131相连的端部与流入侧夹持部1331的与连接支架131相连的端部之间的距离为6毫米;流出侧夹持部1341与流入侧夹持部1331之间的沿连接支架131的纵向中心轴线的距离从连接支架131向外逐渐减小。
流出侧翘起部1343由流出侧夹持部1341的外缘朝靠近流入侧端部111侧的方向延伸形成。流出侧翘起部1343远离流出侧夹持部1341的端部即为流入侧裙边133的自由端。优选地,本实施例中,流出侧翘起部1343为围绕支架主体11的流出侧波形结构,且流出侧翘起部1343在展开状态下平行于连接支架131纵向中心轴。
流出侧裙边134上还设置有多个流出侧锚定件1347。流出侧锚定件1347的自由端朝向左心室侧(也就是流出侧端部113侧)。锚定件1347用于在人工心脏瓣膜100展开时将人工心脏瓣膜100固定在瓣环8上。本实施例中,流出侧锚定件1347设于流出翘起部1343的流出侧波形结构的波峰上。可以理解的是,流出侧锚定件1347也可以设于流出侧夹持部1341上,可以根据实际需要来设定。
与现有技术相比,本发明实施例中的人工心脏瓣膜具有如下明显优势:
(1)该人工心脏瓣膜支架的流入侧裙边与流出侧裙边配合夹持人工心脏瓣膜组织,使得人工心脏瓣膜支架可以稳固地设置于人工心脏瓣膜组织上,延长了具有该人工心脏瓣膜支架的人工心脏瓣膜的使用寿命,降低了患者再次置换瓣膜的风险。
(2)人工心脏瓣膜支架的支架主体与连接支架分别单独成型后再固接为一体,故,在连接支架的裙边的制作过程中,支架主体的结构完整性及力学性能不会被降低,且在使用过程中,人工心脏瓣膜组织对连接支架的裙边所施加的力在连接支架的连接部缓冲的作用下,难以全部传递给支架主体进而难以改变支架主体的形状及尺寸,难以影响瓣叶的流体力学性能。
(3)人工心脏瓣膜支架的心房侧裙边上设有连接孔,便于人工心脏瓣膜的释放和回收。
(4)人工心脏瓣膜支架设有锚定件,提高了具有该人工心脏瓣膜支架的人工心脏瓣膜植入后的稳定性。
(5)人工心脏瓣膜支架设有阻流布,可以有效地防止人工心脏瓣膜植入后瓣周漏的产生;
需要说明的是,因介入医疗器械50需放置于防钙化溶液中保存,所以输送装置40与介入医疗器械50需分开包装。手术前再将介入医疗器械50装载至输送装置40内部。将介入医疗器械50装入输送装置40内部包括以下步骤:首先,将连接环485的自由端穿过介入医疗器械50的连接元件1335,并套于连接柱487上;然后,驱动推杆42以带动连接柱487朝向止挡件483运动,直至连接柱487收容止挡件483的收容体489中;接着,再缓慢地将介入医疗器械50全部装载进入外鞘管43的远端内。
手术方法
以下将详细说明采用输送装置40及介入医疗器械50来置换病变二尖瓣瓣膜的方法。
第一种植入方法在胸腔镜的辅助下进行,其包括以下步骤。
请参阅图19,第一步,在右心耳处缝一个褥式荷包201,其包括:首先,患者左侧卧约30度,在右胸第4肋间胸骨旁开约3厘米小切口,具体地,依次切开皮肤、皮下组织和肌层筋膜,钝性分离肌层至胸膜腔;其次,露出心包;接着,切开心包并悬吊心包,暴露出右心房;然后,在右心耳处缝一个褥式荷包201。其他实施例中,可以根据患者的个体差异及实际需要,患者可左侧卧约30度至45度中的某一角度。可以理解的是,其他实施例中,可以根据患者的个体差异及实际需要,也可以在右心房前侧壁上缝一个褥式荷包,以便后续步骤中穿刺针进入左心房4。可以理解的是,其他实施例中,根据患者的个体差异及实际需要,为了方便手术操作,在右胸上还可以形成除胸腔镜所需的切口之外的两个或者多个小切口,不限于本实施例中的除胸腔镜所需的切口之外的一个小切口。
请一并参阅图20,第二步,将穿刺针202的针尖送入左心房4,具体地,将穿刺针202的针尖从褥式荷包201中部穿刺进入右心房3,并经房间隔31穿刺进入左心房4。可以理解的是,其他实施例中,可以根据患者的个体差异及实际需要,穿刺针202的针尖也可以经卵圆窝301穿刺进入左心房4。请一并参阅图21,第三步,将导丝204的远端沿着穿刺针202内腔送入左心房4,并经过二尖瓣2进入左心室6。
第四步,将穿刺针202从心脏系统撤出。
第五步,请一并参阅图22,测量二尖瓣瓣环8的尺寸。具体地,首先,将载有测瓣器207的输送系统43a的远端沿着导丝204送至左心房4,其次,将测瓣器207从输送系统43a中释放,并测量二尖瓣瓣环8的尺寸,最后,将测瓣器207收回至输送系统43a中。
第六步,将装载有测瓣器207的输送系统43a从心脏系统撤出,并按照所测量的二尖瓣瓣环8的尺寸大小选择合适规格的介入医疗器械50。可以理解的是,其他实施例中,若在术前通过超声和/或电子计算机断层扫描来测量二尖瓣瓣环8的尺寸,则第五步和第六步可以省略不要。
请一并参阅图23,第七步,将载有合适规格的介入医疗器械50的输送装置40的远端沿着导丝204输送至左心室6,勒紧褥式荷包201,并通过调弯单元474调整外鞘管43远端的角度,使得外鞘管43远端与二尖瓣瓣环8所在平面垂直。
第八步,将导丝204从心脏系统撤出。
第九步,将介入医疗器械50从输送装置40中全部露出,并固定于二尖瓣组织上。
具体地,首先,转动第二旋筒472,旋转的第二旋筒472带动外鞘管43相对推杆42向输送装置40的近端缓慢移动,逐渐露出介入医疗器械50,直至介入医疗器械的流出侧裙边134露出外鞘管43;其次,调节调弯单元474的驱动件4742,驱动件4742带动调弯单元474的牵引丝4741来调整外鞘管43远端的角度,使得二尖瓣瓣叶15、12置于流出侧裙边134与支架主体10之间的夹角内(如图24和图25所示);接着,继续旋转第二旋筒472,旋转的第二旋筒472带动外鞘管43相对推杆42向输送装置40的近端缓慢移动,逐渐将介入医疗器械50从外鞘管43中完全推出,且流出侧裙边134上的流出侧锚定件1347扎入二尖瓣瓣环8内,以增加介入医疗器械50在体内的稳定性(如图26和图27所示)。此时,介入医疗器械50上的连接远件1335与推杆42远端通过连接环458相连。若介入医疗器械50位置不够理想时可以转动第二旋筒472,外鞘管43前进,直至将介入医疗器械50全部收入鞘管43中,调整好位置后重新将介入医疗器械50从输送装置40中全部露出,并固定于二尖瓣组织上。
第十步,将介入医疗器械50从输送装置40上释放。具体地,首先,在保持外鞘管43相对外壳41静止的情况下,转动第一旋筒463,转动的第一旋筒463带动第一滑块465及与第一滑块465相连的推杆42相对外壳41缓慢地向近端移动,向近端移动的推杆42带动连接件481远离止挡件483以解除连接柱487对连接环485的束缚,进而将介入医疗器械50从输送装置40上释放(如图28和图29所示)。
第十一步,将内鞘芯44收入外鞘管43内,再将外鞘管43的远端与外鞘管43的近端调整至同一直线上。具体地,首先,在推杆42相对外壳41静止的情况下,转动第二旋筒472,旋转的第二旋筒472驱动外鞘管43的远端缓慢地朝内鞘芯44的远端移动,直至内鞘芯44的远端收入外鞘管43内;其次,通过调弯单元471将外鞘管43的远端与外鞘管43的近端调整至同一直线上(如图30及31所示)。
请参阅图32,第十二步,将导丝204的远端沿着输送装置40中内鞘芯44的内腔再次置入左心房4,撤出输送装置40,并将导丝204保留于左心房4中。
第十三步,通过超声检查房间隔31的穿刺处是否有残余分流。若残余分流明显,需行房间隔封堵术,即,在导丝204的引导下植入封堵器器208对房间隔31穿刺处进行封堵(如图33所示);若无残余分流,将导丝204从心脏系统撤出,并结扎荷包201,缝合右胸小切口,完成整个手术过程。
与现有技术相比,本发明的植入方法具有以下优点:
(1)本发明的手术操作过程中,无需体外循环,避免了外科手术创伤大的危害;
(2)本发明的手术操作过程中,经右胸小切口穿刺,无需经血管路径,介入医疗器械尺寸不受血管尺寸大小的限制,有利于介入医疗器械结构设计的灵活性;
(3)本发明的手术操作过程中,经血流压力较左心室血流压力小且肌层较薄的右心房穿刺,穿刺点不会出血或者出血量较少且穿刺容易;
(4)本发明的介入医疗器械回收装置设置在左心房,避免左室流出道梗阻的发生,提高手术的安全性;
(5)本发明的手术操作过程中,承载介入医疗器械的输送装置距离腱索较远,避免输送装置或介入医疗器械碰触腱索,减少了腱索缠绕输送装置或者介入医疗器械的发生,使手术更安全。
第二种植入介入医疗器械的方法包括如下步骤:
第一步,其与第一种植入方法中的第一步相同,在此不再赘述。
第二步,请参阅图34,将穿刺针202的针尖从褥式荷包201中部穿刺进入右心房3。
第三步,请一并参阅图35及图36,将导丝204的远端沿着穿刺针202的内腔送至右心房3,将穿刺针202从右心房3撤出,并保留导丝204于右心房3内。
第四步,请一并参阅图37及图38,沿着导丝204将输送鞘管80送至右心房3,将导丝204从右心房3撤出,并保留输送鞘管80在右心房3内。输送鞘管80包括相连的主体段801及远端段803。远端段803的近端与主体段801的远端相连,且远端段803的远端朝输送鞘管80的远端延伸(即远端段803的远端朝远离主体段801的近端的方向延伸)。远端段803向远端的延伸方向与主体段801向远端的延伸方向之间具有约20度至30度中某一角度的夹角,也就是说,输送鞘管80具有预定的20度至30度中某一角度。本实施例中,远端段向远端的延伸方向803与主体段801向远端的延伸方向之间具有约30度的夹角。其他实施例中,可以根据患者的个体差异及实际需要,远端段803向远端的延伸方向与主体段801向远端的延伸方向之间可以具有约20度、25度或者28度等角度的夹角。正是由于本实施例的植入方法中采用的输送鞘80具有预定角度,穿刺房间隔31位置时,能够避免手术过程中穿刺针穿刺左心房4的后壁,降低手术风险。
第五步,请一并参阅图39及图40,将导丝204的远端送至左心室6。具体地,首先,将穿刺针或者射频打孔针90的针尖从输送鞘管80内部送至右心房3,并将穿刺针或者射频打孔针90的针尖通过穿刺或者打孔的方式经房间隔31送至左心房4;其次,将输送鞘管80从右心房3撤出;然后,将导丝204的远端沿着穿刺针或者射频打孔针90的内腔送至左心房4,并经过二尖瓣2进入左心室6处;接着,将穿刺针或者射频打孔针90从心脏系统撤出,并保留导丝204的远端在左心室6内。如此,导丝204的远端即被送至左心室6。
其余步骤与第一植入方法中的第五步至第十三步相同,在此不再赘述。
第三种植入介入医疗器械的方法包括如下步骤:
第一步,在右心房3前侧壁32上缝两个褥式荷包201、203,具体地,包括:首先,患者左侧卧约40度,在右胸第4肋间胸骨旁开约3厘米的小切口,具体地,依次切开皮肤、皮下组织和肌层筋膜,钝性分离肌层至胸膜腔;其次,露出心包;接着,切开心包并悬吊心包,暴露出右心房;然后,在右心房前壁32缝褥式荷包201及褥式荷包203(如图41所示)。可以理解的是,其他实施例中,根据患者的个体差异及实际需要,为了方便手术操作,在右胸上还可以形成两个或者多个小切口,不限于本实施例中的一个小切口。
第二步,将穿刺针202、205的针尖分别送入左心房4,具体地,将穿刺针202及205的针尖分别从褥式荷包201中部及荷包203的中部穿刺进入右心房3,并穿刺房间隔31进入左心房4(如图42所示)。
第三步,将导丝204的远端沿着穿刺针202内腔依次经右心房3、房间隔31、左心房4及二尖瓣2进入左心室6将导丝206的远端沿着穿刺针205内腔经右心房3及房间隔31进入左心房4(如图43所示)。
第四步,将手术辅助装置73送至左心房4。具体地,首先,将穿刺针202及205从心脏系统撤出(如图44所示);其次,将带有扩张器71的输送鞘管70的远端沿着导丝206进入左心房4,并勒紧褥式荷包203(如图45所示);接着,将导丝206及扩张器71从心脏系统撤处;最后,将手术辅助装置73通过输送鞘管70送至于左心房4中,以对手术进行辅助(如图46所示)。本实施例中,手术辅助装置73为超声探头。其他实施例中,手术辅助装置73也可以为手术机器人。
第五步,将载有瓣膜器械50的输送装置40的远端沿着导丝204输送至左心室6,勒紧褥式荷包201,并在手术辅助装置73辅助作用下调整外鞘管43,使得鞘管43远端的角度与二尖瓣2所在平面垂直(如图47所示)。可以理解的是,在其他实施例中,第三种植入方法在第四步与第五步之间还可以包括如第一植入方法中的测量二尖瓣瓣环8的尺寸的步骤以帮助选择介入医疗器械50的步骤。
可以理解的是,其他实施例中,当手术辅助装置73为超声探头时,第四步与第五步中的将载有瓣膜器械50的输送装置40的远端沿着导丝204输送至左心室6可以同时进行,只要调整外鞘管43远端角度时,手术辅助装置73已经被送至左心房4且可以辅助调整外鞘管43即可。还可以理解的是,其他实施例中,当手术辅助装置73为超声探头时,第五步中的将载有瓣膜器械50的输送装置40的远端沿着导丝204输送至左心室6也可以在第四步之前进行,只要调整外鞘管43远端角度时,手术辅助装置73已经被送至左心房4且可以辅助调整外鞘管43即可。
第六步至第十二步与第一植入方法中的第六步至第十二步相同,在此不再赘述。
第十三步,通过超声检查房间隔31的穿刺处是否有残余分流。若残余分流明显,需行房间隔封堵术,即,在导丝204的引导下植入封堵器器208对房间隔31穿刺处进行封堵(如图48所示);若无残余分流,则将输送装置40、输送鞘管70及手术辅助装置73从心脏系统撤出,结扎荷包201及荷包203,缝合右胸小切口,完成整个手术过程。
可以理解的是,当输送装置40的外鞘管43具有两个内腔,该两个内腔分别用来输送介入医疗器械及手术辅助装置时,上述的两个穿刺通道也可以被一个穿刺通道来代替。
本发明还提供了第四种植入介入医疗器械50的方法,该方法在胸腔镜的辅助下进行,其包括如下步骤:
第一步,请一并参阅图49及图50,在房间沟的预穿刺位置36缝一个褥式荷包201,其包括:首先,在右前胸腋前线第4肋间开约2.5厘米的小切口,具体地,依次切开皮肤、皮下组织和肌层筋膜,钝性分离肌层至胸膜腔;其次,露出心包;接着,切开心包并悬吊心包,暴露出房间沟310;然后,在胸腔镜引导下确定预穿刺位置36,并在该预穿刺位置36周围缝一个褥式荷包201。
第二步,请参阅图51,将穿刺针202的针尖从褥式荷包201中部穿刺房间沟310进入左心房4。
第三步至第十一步与第一种植入方法中的第三步至第十一步的步骤大致相同,在此不再赘述。
第十二步,请参阅图52,将除介入医疗器械50外的所有器械从患者体内撤出,结扎荷包201,缝合右胸小切口,完成整个手术过程。
本发明第四种植入介入医疗器械50的过程中,无需体外循环,避免了外科手术创伤大的危害;经右胸小切口穿刺,无需经血管路径,介入医疗器械尺寸不受血管尺寸大小的限制,有利于介入医疗器械结构设计的灵活性;经血流压力较左心室血流压力小的房间沟穿刺,穿刺点不会出血或者出血量较少且穿刺容易;介入医疗器械回收装置设置在左心房,避免左室流出道梗阻的发生;承载介入医疗器械的输送装置距离腱索较远,输送装置或介入医疗器械难以碰触腱索,减少了腱索缠绕输送装置或者介入医疗器械的可能性,操作过程较为简单。
可以理解的是,其他实施例中,也可以在左心房壁上缝一个褥式荷包,穿刺针的针尖也可以经左心房壁上的褥式荷包穿刺进入左心房,此种情况下,待穿刺针的针尖进入左心房后,植入方法的其他步骤也可以采用第四种植入方法中的第三步至第十二步。还可以理解的是,本发明的植入方法不单可以用于植入人工二尖瓣瓣膜,还可以稍加改变来完成三尖瓣瓣膜置换、二尖瓣瓣环修复、左心耳封堵,心脏除颤等手术。
请参阅图53,本发明又一实施例提供了一种人工心脏瓣膜支架10a,其包括管状支架主体11a、及设于支架主体11a外壁的流入侧裙边133a、设于支架主体11a外壁的流出侧裙边134a、设于流出侧裙边134a上的阻流布135a。流入侧裙边133a及流出侧裙边134a的自由端均朝支架主体11a的流入侧端部111a侧延伸。流入侧裙边133a用于与流出侧裙边134a配合夹持人工心脏瓣膜组织。流入侧裙边134a的与支架主体11a相连的端部与流出侧裙边134a的与支架主体11a相连的端部之间的距离范围为2至6毫米。本实施例中,流入侧裙边133a及流出侧裙边134a均通过编织的方式设置于支架主体11a上,且阻流布135a仅设于流出侧裙边134a上;流入侧裙边134a的与支架主体11a相连的端部与流出侧裙边134a的与支架主体11a相连的端部之间的距离为2毫米。
请一并参阅图54及55,流入侧裙边133a设于支架主体11a的流入侧端部111a,其包括多个相互分离的第一裙边子单元1332a。每个第一裙边子单元1331a均由镍钛丝编织且定型后形成,且通过编织的方法设置于支架主体11a上。每个第一裙边子单元1332a均包括流入侧夹持部子单元1331a及流入侧跷起部子单元1333a。流入侧夹持部子单元1331a位于流入侧翘起部子单元1333a与支架主体11a之间。每个流入侧夹持部子单元1331a均大致平行于支架主体11a的垂直于其纵向中心线的横截面。每个流入侧翘起部子单元1333a均大致平行于支架主体11a的纵向中心线。多个流入侧夹持部子单元1331a共同构成流入侧裙边133a的流入侧夹持部;多个流入侧翘起部子单元1333a共同构成流入侧裙边133a的流入侧翘起部。
可以理解的是,流入侧裙边133a中的至少一个第一裙边子单元1332a也可以通过焊接的方式连接在支架主体11a除流入侧端部111a的其他根据实际需要的部位。还可以理解的是,流入侧裙边133a上也可以设置自由端朝向流出侧端部113a侧的流入侧锚定件;流入侧裙边133a上也可以设置可以与输送系统可拆卸连接的连接元件。
请一并参阅图56及图57,流出侧裙边134a包括多个相互分离的第二裙边子单元1342a。优选地,本实施例中,第二裙边子单元1342a的个数与第一裙边子单元1332a的个数相等,且多个第二裙边子单元1342a与多个第一裙边子单元1332a一一对应。
每个第二裙边子单元1342a均由镍钛丝编织且定型后形成,且通过编织的方法设置于支架主体11a上。每个第二裙边子单元1342a均包括流出侧夹持部子单元1341a及流出侧跷起部子单元1343a。流出侧夹持部子单元1341a位于流出侧翘起部子单元1343a与支架主体11a之间。每个流出侧夹持部子单元1341a与支架主体11a纵向中心线之间具有夹角。
本实施例中,每个流出侧夹持部子单元1341a与支架主体11a纵向中心线之间具有夹角的度数为五十度;每个流出侧夹持部子单元1341a与相应的流入侧夹持部子单元1331a之间的沿支架主体11a的纵向中心轴线的距离从支架主体11a向外逐渐减小。每个流出侧翘起部子单元1343a均大致平行于支架主体11a的纵向中心线。多个流出侧夹持部子单元1341a共同构成流出侧裙边134a的流出侧夹持部;多个流出侧翘起部子单元1343a共同构成流出侧裙边134a的流出侧翘起部。每个第二裙边子单元1342a还包括由多条编织线交叉形成的网格1345a,以便于更好地设置阻流布135a。可以理解的是,网格1345a的格线上还可以设有流出侧锚定件。
可以理解的是,流出侧裙边134a中的至少一个第二裙边子单元1342a也可以通过焊接的方式设置于支架主体11a上。还可以理解的是,流出侧裙边134a也可以由第一实施例中的流出侧裙边134替代。还可以理解的是,流入侧裙边133a也可以由第一实施例中的流入侧裙边133替代。
可以理解的是,虽然本发明所描述的植入方法并未经血管、经心尖或者其他方式介入,但是依据患者的个体差异及实际情况,经血管或者心尖或者其他方式介入的、和本发明的介入医疗器械50结构相同的介于医疗器械仍然属于本发明所请求保护的介入医疗器械的保护范围。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (20)
- 一种人工心脏瓣膜支架,包括具有相对的流入侧端部及流出侧端部的管状支架主体、围绕所述支架主体外壁的流入侧裙边及围绕所述支架主体外壁的流出侧裙边,在展开状态下,所述流入侧裙边及所述流出侧裙边的自由端均朝所述流入侧端部侧延伸,所述流入侧裙边用于与流出侧裙边配合夹持心脏瓣膜组织。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述人工心脏瓣膜支架还包括围绕所述支架主体外壁的管状连接支架,所述流入侧裙边及流入侧裙边分别位于所述管状连接支架的两端。
- 根据权利要求2所述的人工心脏瓣膜支架,其特征在于,所述管状连接支架与所述主体支架分别单独成型再固定连接为一体。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边的与所述管状支架主体相连的端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影,与所述流入侧端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影相分离。
- 根据权利要求4所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边的与所述管状支架主体相连的端部与所述流入侧端部之间的距离,大于或等于所述流出侧裙边的与所述管状支架主体相连的端部与所述流出侧端部之间的距离。
- 根据权利要求4所述的人工心脏瓣膜支架,其特征在于,所述流出侧裙边的与所述管状支架主体相连的端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影,与所述流出侧端部在平行于所述管状支架主体的纵向中心轴线的截面上的投影相分离。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边包括与所述支架主体相连的流入侧夹持部、及与所述流入侧夹持部相连的流入侧翘起部,所述流入侧夹持部位于所述流入侧翘起部与所述支架主体之间,所述流入侧翘起部远离所述流入侧夹持部的端部为所述流入侧裙边的自由端,且所述流入侧翘起部与所述流入侧夹持部之间具有夹角。
- 根据权利要求7所述的人工心脏瓣膜支架,其特征在于,所述流入侧翘起部包括围绕所述支架主体的流入侧波形结构。
- 根据权利要求7所述的人工心脏瓣膜支架,其特征在于,所述流出侧裙边包括与所述支架主体相连的流出侧夹持部、及与所述流出侧夹持部相连的流出侧翘起部,所述流出侧夹持部位于所述流出侧翘起部与所述支架主体之间,所述流出侧翘起部远离所述流出侧夹持部的端部为所述流出侧裙边的自由端,且所述流出侧翘起部与所述流出侧夹持部之间具有夹角。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边包括多个相互分离的第一裙边子单元,每个所述第一裙边子单元均通过编织的方法设于所述支架主体上。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边上设有多个流入侧锚定件,所述流入侧裙边上的流入侧锚定件的自由端朝所述流出侧端部侧延伸。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边的与所述管状支架主体相连的端部和所述流出侧裙边的与所述管状支架主体相连的端部之间的距离范围为2至6毫米。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边的自由端上设有多个连接元件。
- 根据权利要求1所述的人工心脏瓣膜支架,其特征在于,所述流入侧裙边与流出侧裙边中至少一个裙边上覆盖有阻流布。
- 一种人工心脏瓣膜,其包括如权利要求1所述的人工心脏瓣膜支架和瓣叶,所述瓣叶设于所述管状支架主体内部。
- 一种介入医疗器械的植入方法,其包括:在右胸上形成小切口露出心房,及将如权利要求1所述的人工心脏瓣膜经所述小切口送至心脏系统的植入位置,并固定于心脏系统的组织上。
- 根据权利要求16所述的植入方法,其特征在于,所述心脏瓣膜为人工二尖瓣瓣膜,在右胸上形成小切口露出心房步骤之后,将所述的心脏瓣膜经所述小切口送至心脏系统的植入位置步骤之前,所述植入方法还包括将导丝经所述小切口送至左心室的步骤。
- 根据权利要求17所述的植入方法,其特征在于,将所述导丝经所述小切口送至左心室包括步骤:在心房壁上缝褥式荷包;将穿刺针的针尖经所述褥式荷包送入左心房;及将导丝的远端沿着所述穿刺针内腔送入左心房,并经过二尖瓣进入左心室。
- 根据权利要求18所述的植入方法,其特征在于,将所述导丝经所述小切口送至左心室包括步骤:在右心房壁上缝一个褥式荷包;将射频打孔针的针尖经所述褥式荷包、右心房及房间隔送至左心房;及将所述导丝的远端沿着所述射频打孔针内腔送入左心房,并经过二尖瓣进入左心室。
- 根据权利要求17所述的植入方法,其特征在于,将所述导丝经所述小切口送至左心室包括步骤:在房间沟的预穿刺位置周围缝一个褥式荷包;将穿刺针的针尖经所述褥式荷包送入左心房;及将所述导丝的远端沿着所述穿刺针内腔送入左心房,并经过二尖瓣进入左心室。
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Also Published As
Publication number | Publication date |
---|---|
CN105581858B (zh) | 2018-04-10 |
US20180360600A1 (en) | 2018-12-20 |
EP3391856A1 (en) | 2018-10-24 |
US11071624B2 (en) | 2021-07-27 |
EP3391856B1 (en) | 2023-05-10 |
EP3391856A4 (en) | 2019-07-31 |
CN105581858A (zh) | 2016-05-18 |
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