CN116407363B - A delivery device and delivery system for an interventional heart valve stent - Google Patents
A delivery device and delivery system for an interventional heart valve stent Download PDFInfo
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- CN116407363B CN116407363B CN202210474024.5A CN202210474024A CN116407363B CN 116407363 B CN116407363 B CN 116407363B CN 202210474024 A CN202210474024 A CN 202210474024A CN 116407363 B CN116407363 B CN 116407363B
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 79
- 239000002775 capsule Substances 0.000 claims abstract description 54
- 238000005452 bending Methods 0.000 claims description 39
- 239000000463 material Substances 0.000 claims description 5
- 230000006835 compression Effects 0.000 claims description 3
- 238000007906 compression Methods 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- 230000002457 bidirectional effect Effects 0.000 abstract description 2
- 210000001765 aortic valve Anatomy 0.000 description 11
- 238000000034 method Methods 0.000 description 8
- 208000003017 Aortic Valve Stenosis Diseases 0.000 description 7
- 206010002906 aortic stenosis Diseases 0.000 description 7
- 201000002064 aortic valve insufficiency Diseases 0.000 description 5
- 230000009471 action Effects 0.000 description 4
- 238000002513 implantation Methods 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 206010002915 Aortic valve incompetence Diseases 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 208000018578 heart valve disease Diseases 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000001105 femoral artery Anatomy 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 208000027896 Aortic valve disease Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- GYSSRZJIHXQEHQ-UHFFFAOYSA-N carboxin Chemical compound S1CCOC(C)=C1C(=O)NC1=CC=CC=C1 GYSSRZJIHXQEHQ-UHFFFAOYSA-N 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000002592 echocardiography Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention relates to a conveying device of an interventional heart valve stent, which comprises a conveying main body, wherein the conveying main body comprises an inner core, an inner sheath and an outer sheath which are movably sleeved in sequence from inside to outside, the distal end of the inner core is connected with a TIP head, and a support arm and a fixing block can be respectively detachably connected with the proximal end and the distal end of the heart valve stent through a stent fixing component comprising a limiting piece, a fixing piece, a containing capsule and the fixing block, so that a bidirectional detachable connection mode is realized.
Description
Technical Field
The invention relates to the technical field of interventional heart valve operation related equipment, in particular to a conveying device and a conveying system of an interventional heart valve bracket.
Background
With aging population, the incidence rate of valvular heart disease is obviously increased, and the traditional surgical treatment is still the first treatment means for most patients with severe valvular disease at present, but the risks of great wound, postoperative mortality, higher complications and the like exist. In recent years, transcatheter valve implantation/repair has become mature and widely used, and particularly, transcatheter aortic valve implantation (TAVR/TAVI) has been based on evidence, so that trauma is greatly reduced, recommendations of european and american guidelines for treatment of heart valve diseases are obtained, and the transcatheter valve implantation/repair is a milestone development in the field of interventional treatment of heart valve diseases.
Transcatheter Aortic Valve Implantation (TAVI), a new technique for inserting prosthetic aortic valves by interventional procedures, was first reported in 2002 by Criber physicians in france, and has brought promise for the treatment of patients with severe aortic valve stenosis (AS) who lost surgical opportunities (e.g., >80 years), and has opened a new page in the history of cardiovascular intervention. Over 10 years thereafter, as instruments improve and experience has accumulated, TAVI technology has continued to improve, with sequential expansion in more than 500 heart centers in nearly 40 countries, with a total number of procedures exceeding 15 tens of thousands. Particularly, after a series of registration studies and random control studies have successively confirmed the effectiveness, feasibility and safety of the patients, the TAVI technology has become the treatment of choice for serious AS patients who cannot surgically change petals. Clinically TAVI uses prosthetic biological valves, mainly two types, balloon-inflated EDWARDS SAPIEN (edwardsier, usa) and self-inflated CoreValve (midwifery, usa). TAVI technology has made remarkable progress internationally, has preliminary application in China, has a wide prospect, is a highly monopolized market by foreign brands at present, and takes up about 85% of market share by Edwards Life sciences (Edwards Lifesciences), medun power, livaNova (acquired by Solin), santa hesis (acquired by Yam) and On-X and other foreign enterprises, wherein Edwards Life sciences and Medun power have all product pipelines from mechanical valves, biological valves to transcatheter intervention, and a lot of domestic appliance enterprises are also emerging, and three manufactured transcatheter aortic valves are marketed through the approval of CFDA in China at present, namely J-valve in Venus-A and Suzhou Jie, which are enlightenment medical, and VitaFlow in micro-invasive heart communication, respectively, but none of the domestic enterprises have absolute leading advantages.
According to the echocardiography database statistical analysis of hospital patients, the detection rates of the moderate or severe aortic valve insufficiency (AR) in patients between 65 and 74 years old (49995 cases) and more than or equal to 75 years old (34671 cases) are respectively 2.12 percent and 2.85 percent, the detection rates of the moderate or severe aortic valve stenosis (AS) are respectively 0.75 percent and 0.89 percent, and the detection rates of the two groups in the severe aortic valve insufficiency (SAR) and the severe aortic valve stenosis (SAS) are respectively 0.52 percent VS0.95 percent and 0.54 percent VS0.57 percent. As can be seen, elderly people in china are more prone to aortic insufficiency in aortic valve degeneration. The aortic valve disease patients in China have a certain difference from western countries: ① The proportion of the two-leaf aortic valves in China is high, the proportion of the two-leaf aortic valves is 40% -50%, the proportion is far higher than 1.6% -9.3% of that in Western countries, and a plurality of large-scale TAVR clinical researches in Western countries are used for classifying the two-leaf aortic valves as exclusion criteria. ② The calcification degree of the aortic valve of the patients in China is higher. ③ The aortic valve regurgitation in China is more than aortic valve stenosis. ④ The internal diameter of the femoral artery is thinner, and the average internal diameter of the femoral artery of a TAVR candidate case in China is 6.5mm.
The artificial valve stent can be conveyed to the aortic valve through the conveying system and opened, so that the artificial valve is placed in the aortic valve, the function of the prosthetic valve is recovered, and the problems of influence on the accurate release of the artificial valve stent still exist in the installation of the conveying system and the artificial valve stent.
Disclosure of Invention
Based on the above description, the invention provides a delivery device of an interventional heart valve stent, so as to meet the requirement of accurate release of the heart valve stent.
The technical scheme for solving the technical problems is as follows:
The utility model provides a conveyor of intervention formula heart valve support, includes the transport main part, the transport main part includes interior core, interior sheath pipe and the outer sheath pipe of movable cover of cover setting in proper order from inside to outside, the distal end of interior core is connected with the TIP head, its characterized in that, conveyor still includes support fixed subassembly, the transport main part still includes the support pipe;
the support tube is movably and coaxially sleeved between the inner core and the inner sheath tube, two ends of the inner core extend out of two ends of the support tube respectively, and the far end of the inner sheath tube is provided with an accommodating cavity;
The support fixing assembly comprises a limiting piece, a fixing piece, a containing capsule and a fixing block, wherein the limiting piece is of an elongated strip-shaped structure, the limiting piece axially penetrates through the inner sheath tube and can extend out of two ends of the inner sheath tube, the fixing piece comprises a connecting part positioned at the far end of the inner sheath tube and a support arm extending from the connecting part to the far end, the fixing block is connected to the far end of the support tube, the fixing block is positioned between the fixing piece and the TIP head, the containing capsule is connected to the TIP head, and the near end of the containing capsule is provided with a capsule cavity; the support arm and the fixed block are respectively used for being detachably connected with the proximal end and the distal end of the heart valve bracket so as to place the heart valve bracket in the accommodating cavity or the capsule cavity in a compression mode; the distal end of the stop member is used for limiting the connection of the proximal end of the heart valve stent and the support arm to prevent the proximal end of the heart valve stent and the support arm from being disconnected.
Compared with the prior art, the technical scheme of the application has the following beneficial technical effects:
According to the conveying device provided by the application, the support arm and the fixing block can be detachably connected with the proximal end and the distal end of the heart valve support respectively through the support fixing assembly comprising the limiting piece, the fixing piece and the holding capsule and the fixing block, so that a bidirectional detachable connection mode is realized, compared with a unilateral fixing method, the release position of the heart valve support is more accurate, and redundant adjustment work is avoided.
On the basis of the technical scheme, the invention can be improved as follows.
Further, the support fixing assembly further comprises a dismounting piece, the dismounting piece is detachably mounted at the proximal end of the inner sheath tube and connected with the proximal end of the limiting piece, and when the heart valve support is located in the capsule cavity, the limiting piece can be pulled by the dismounting piece to enable the distal end of the limiting piece to release connection limiting of the proximal end of the heart valve support and the supporting arm.
After the technical scheme is adopted, the remote end of the limiting piece is pulled by the makeup removing piece to release the connection limit of the proximal end of the heart valve support and the support arm, so that the heart valve support is conveniently released, and no deviation is caused between the actual release position and the preset release position.
Further, the capsule comprises a capsule tube section and an extension tube section, and at least part of an inner core positioned in the extension tube section is made of a memory material, so that the capsule and the TIP head can be automatically bent under the action of no external force.
After adopting above-mentioned technical scheme, through the design of extension pipe section and memory material, guaranteed that this conveyor can not exist because of the distal end overlength and impale heart risk, can not receive the restriction of heart size in the use, it is more nimble to use.
Further, the inner diameter dimension of the extension tube section is greater than the inner diameter dimension of the capsule tube section.
After the technical scheme is adopted, most of tension of the heart valve support can be intensively released on the inner wall of the capsule tube section, and the pressure born by the extension tube section is greatly reduced.
Further, the conveying main body further comprises a multi-cavity tube, a through hole is formed between two ends of the multi-cavity tube in a penetrating mode, and the limiting piece movably penetrates through the through hole.
After the scheme is adopted, the movement of the limiting part in the inner sheath tube is not influenced by the movement of the inner core and the inner sheath tube, and the stability of releasing the heart valve support when the limiting part is pulled is ensured.
Further, the conveying device further comprises two bending adjusting handles, the two bending adjusting handles are respectively used for adjusting the bending degree of the inner sheath tube and the bending degree of the outer sheath tube, and the bending adjusting handles used for adjusting the bending degree of the outer sheath tube are connected with the outer sheath tube and detachably sleeved on the inner sheath tube.
Further, the bending handle comprises a first shell, a first sliding block and a bending wire, a first sliding way is formed in the first shell, the first sliding block can slide along the first sliding way, the proximal end of the bending wire is connected with the first sliding block, and the distal end of the bending wire is connected with the distal end of the corresponding inner sheath tube or the distal end of the corresponding outer sheath tube.
Further, the bending handle further comprises a rotating handle, a tooth block and a supporting slide way, the first shell comprises an outer shell and an outer cover which is connected to two ends of the outer shell in a sealing mode, the rotating handle is rotatably installed on the outer shell, an inner thread is arranged on the inner side of the rotating handle, the supporting slide way is installed on the rotating handle, the tooth block can be axially and slidably sleeved on the supporting slide way, a limiting through groove which is matched with a limiting strip on the outer side of the supporting slide way to limit is formed in the inner side of the tooth block, an outer thread which is matched with the inner thread is arranged on the outer side of the tooth block, the first sliding block is slidably sleeved on the supporting slide way, and the tooth block can drive the first sliding block to slide.
After the scheme is adopted, the bending degree of the inner sheath tube and the bending degree of the outer sheath tube can be freely adjusted through the two bending adjusting handles, so that the stable conveying of the heart valve stent by the conveying device is realized.
Further, the conveying device further comprises a telescopic assembly, the telescopic assembly comprises a second shell and a second sliding block, a second slideway is arranged in the second shell, and the second sliding block is fixedly connected with the inner core and can slide along the second slideway.
After the scheme is adopted, the inner core can be pulled or stretched together with the accommodating capsule and the TIP head through the telescopic component, so that the heart valve stent can be conveniently installed and released.
The invention also provides a delivery system comprising a heart valve stent and the delivery device as claimed in any one of claims 1 to 9, wherein the heart valve stent comprises a stent body, a positioning member and a first release member, the stent body can be compressed in the radial direction and is accommodated in the accommodating cavity or the capsule cavity, the positioning member is connected to one end of the stent body and can be folded over naturally towards the other end without being subjected to external force, the proximal end of the stent body can be detachably connected with the support arm, and the first release member is connected to the distal end of the stent body and can be detachably connected with the fixing block.
Compared with the prior art, the technical scheme of the application has the following beneficial technical effects:
According to the conveying system provided by the application, the positioning piece which can be folded is matched with the conveying device, so that the position of two ends of the heart valve support can be fixed, the heart valve support cannot deviate in position in the process of being plugged into the accommodating cavity or the capsule cavity, the heart valve support has an accurate release position, and when the support is plugged into the cavity at one side far away from the positioning piece, the positioning piece does not need to be folded, and can be fed into the cavity along with the feeding of the support body, so that the plugging process of the heart valve support is greatly simplified.
Further, the heart valve stent further comprises a second release member coupled to the proximal end of the stent body and detachably coupled to the arm.
Further, the end part of the support arm is provided with a limiting ring, the second release piece is provided with a coil which can penetrate through the limiting ring, and the far end of the limiting piece can be penetrated through the coil to limit the separation of the coil and the limiting ring.
Furthermore, the number of the second release pieces and the number of the support arms are both greater than or equal to 2, and the distal ends of the limiting pieces can be sequentially penetrated with a plurality of coils.
Further, the fixing piece is provided with a plurality of support arms, the number of the second release piece and the number of the limiting piece are both greater than or equal to 2, and the distal ends of the limiting pieces can be correspondingly penetrated with the coils one by one.
After the scheme is adopted, the coil stretches into the limiting ring to realize detachable connection of the support arm and the second release piece, and meanwhile, the distal end of the limiting piece penetrates through the coil to realize limiting, so that limiting connection of the proximal end of the heart valve support is effectively realized, limiting can be released through pulling of the limiting piece, and mounting and release are facilitated.
Further, the fixing block is provided with a limit groove or a limit protrusion, and the first release piece is provided with a T-shaped part detachably connected with the limit groove or an annular part detachably connected with the limit protrusion.
Drawings
Fig. 1 is a schematic structural diagram of a delivery device for an interventional heart valve stent according to an embodiment of the present invention;
FIG. 2 is a schematic view of an assembled cross-sectional structure of the delivery body and stent fixation assembly;
FIG. 3 is a schematic view of an assembled perspective of the delivery body and the stent fixation assembly;
FIG. 4 is a schematic view of the structure of a multi-lumen tube;
FIG. 5 is a schematic view of the bending of the capsule;
FIG. 6 is a schematic cross-sectional view of a bending handle;
FIG. 7 is a schematic cross-sectional view of a telescoping assembly;
FIG. 8 is a schematic diagram showing the overall structure of a conveying system according to a second embodiment;
FIG. 9 is a schematic cross-sectional view of a fixed block;
FIG. 10 is a schematic perspective view of a fastener;
FIG. 11 is a schematic illustration of the attachment of a heart valve stent to a holder;
fig. 12 is a schematic illustration of the attachment of a heart valve stent to a fixed block.
Detailed Description
In order that the application may be readily understood, a more complete description of the application will be rendered by reference to the appended drawings. Embodiments of the application are illustrated in the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
It will be appreciated that spatially relative terms such as "under … …," "under … …," "under … …," "over … …," "over" and the like may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements or features described as "under" or "beneath" other elements would then be oriented "on" the other elements or features. Thus, the exemplary terms "below … …" and "under … …" may include both an upper and a lower orientation. Furthermore, the device may also include an additional orientation (e.g., rotated 90 degrees or other orientations) and the spatial descriptors used herein interpreted accordingly.
It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or be connected to the other element through intervening elements. In the following embodiments, "connected" is understood to mean "electrically connected", "communicatively connected", and the like, if the connected circuits, modules, units, and the like have electrical or data transferred therebetween.
As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," and/or the like, specify the presence of stated features, integers, steps, operations, elements, components, or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof.
Example 1
As shown in fig. 1 to 3, the present embodiment provides a delivery device of an interventional type heart valve stent, which is used as a delivery unit of a heart valve stent 200, and is mainly used for delivering the heart valve stent 200 from outside to a heart site of a patient, and includes a delivery main body 10 and a stent fixing assembly 20.
Wherein, the conveying main body 10 is taken as a basic component part of the conveying device, and comprises an inner core 11, a supporting tube 12, an inner sheath tube 13 and an outer sheath tube 14 which are movably sleeved in sequence from inside to outside, and the distal end of the inner core 11 is connected with a TIP head 15; the support tube 12 is movably and coaxially sleeved between the inner core 11 and the inner sheath tube 13, two ends of the inner core 11 respectively extend out from two ends of the support tube 12, and a containing cavity is formed at the distal end of the inner sheath tube 13.
It will be appreciated that the proximal end of the present application and embodiments thereof will be referred to as the end of the delivery device that is closer to the user when in use, and the distal end as the end that is closer to the patient.
The bracket fixing assembly 20 includes a stopper 21, a fixing member 22, a receiving capsule 23, a fixing block 24, and a discharging member 25.
Wherein, as shown in FIG. 3, the fixing member 22 includes a connection portion 221 at the distal end of the inner sheath 13 and a support arm 222 extending distally from the connection portion 221; a fixed block 24 is connected to the distal end of the support tube 12, the fixed block 24 is positioned between the fixed member and the TIP head 15, the capsule 23 is connected to the TIP head 15, and the proximal end of the capsule 23 is provided with a capsule cavity; the arms 222 and the fixed block 24 are adapted to be detachably connected to the proximal and distal ends of the heart valve stent 200, respectively, to place the heart valve stent 200 in the receiving or capsule cavity by compression.
The support arm 222 and the fixing block 24 are detachably connected with the proximal end and the distal end of the heart valve stent 200 respectively, and positioning of the two ends can be achieved when the heart valve stent 200 is installed, so that compared with the existing unilateral fixing method on the market, the heart valve stent 200 is more accurate in position in the later release process, and redundant adjustment work is avoided.
The limiting piece 21 is of an elongated strip-shaped structure, the limiting piece 21 axially penetrates through the inner sheath 13 and can extend out of two ends of the inner sheath 13, and the distal end of the limiting piece 21 is used for limiting connection between the proximal end of the heart valve support 200 and the support arm so as to prevent the proximal end of the heart valve support 200 from being separated from the support arm 222.
As shown in fig. 7, the detachable member 25 is detachably mounted on the proximal end of the inner sheath 13 and connected to the proximal end of the stopper 21, and when the heart valve stent 200 is located in the capsule cavity, the distal end of the stopper 21 is released from the connection between the proximal end of the heart valve stent 200 and the arm by pulling the stopper 21 by the detachable member 25.
In some embodiments, the unloading member 25 is movably plugged at the proximal end position of the inner sheath 13, after the proximal end of the heart valve stent 200 and the connection between the support arms are limited, the heart valve stent 200 is conveyed to a proper position by the conveying main body 10, and then the release of the heart valve stent 200 is realized by pulling the unloading member 25 to drive the limiting member to release the limitation, and the release manner is simple and efficient, so that no deviation occurs between the actual release position and the preset release position.
In a preferred embodiment, as shown in fig. 4, the capsule 23 includes a proximal capsule tube segment 231 and a distal extension tube segment 232, at least a portion of the inner core 11 inside the extension tube segment 232 is made of a memory material, so that the capsule and the TIP head can be bent automatically under the action of no external force, and such design effectively increases the length of the capsule 23, so that the capsule cavity has a longer axial depth, and the heart valve stent 200 is convenient to enter the capsule cavity, but due to the size limitation of the heart of a human body, the overlong capsule 23 and the TIP head are arranged, so that the heart is at risk of piercing, so that a portion of the inner core inside the extension tube segment 232 is made of a memory material, so that the inner core 11 can be bent according to a preset memory shape after extending into the heart, and in a specific implementation, the bent shape is preferably a ring-shaped pigtail shape or a sphere shape wrapping the end of the TIP head 15, so that the use of the capsule is not limited by the heart size, and the operation and use of the capsule can be more flexibly made into a flexible tube segment 232 or a flexible tube with a predetermined shape.
When the heart valve stent 200 is compressed and placed in the capsule cavity, part of the heart valve stent is positioned in the capsule tube section 231 and part of the heart valve stent is positioned in the extension tube section 232, and when the extension tube section 232 adopts a flexible hose, the heart valve stent 200 needs to bear large tension force, so that in a more preferred embodiment of the application, the inner diameter size of the extension tube section 232 is larger than the inner diameter size of the capsule tube section 231, and by the arrangement of the size, most of the tension force can be intensively released on the inner wall of the capsule tube section 231, and the pressure born by the extension tube section 232 is greatly reduced.
In order to ensure that when there are a plurality of limiting members 21, the pulling between the limiting members 21 will not affect each other, and further ensure the stability of the heart valve stent 200 released by the pulling of the limiting members 21, the delivery main body 10 further includes a multi-lumen tube 16, and a through hole is formed between two ends of the multi-lumen tube 16, and the limiting members 21 movably penetrate through the through hole.
To facilitate delivery of the heart valve stent 200, as shown in fig. 1 in combination with fig. 6 and 7, the delivery device provided by the present application further includes two bending handles 30 and a telescoping assembly 40.
Specifically, the two bending adjustment handles 30 are respectively used for adjusting the bending degrees of the inner sheath tube 13 and the outer sheath tube 14, wherein the bending adjustment handles 30 used for adjusting the bending degree of the outer sheath tube 14 are connected with the outer sheath tube 14 and detachably sleeved on the inner sheath tube 13.
In an embodiment of the present application, each bending handle 30 includes a first housing 31, a first slider 32, and a bending wire 33.
The first housing 31 is internally formed with a first slide rail axially arranged, along which the first slide rail 32 is slidable, and the proximal end of the bending wire 33 is connected to the first slide rail 32, and the distal end of the bending wire 33 is connected to the distal end of the corresponding inner sheath 13 and the distal end of the corresponding outer sheath 14, respectively, according to the difference in the main body of the bending degree to be adjusted.
Specifically, in order to realize the sliding of the first slider 32 in the first slide way, as a preferred embodiment, the bending handle 30 further includes a knob 34, a tooth block 35 and a supporting slide way 36, the first housing 31 includes a housing 311 and an outer cover 312 sealingly connected to two ends of the housing 311, the knob 34 is rotatably mounted on the housing 311, in this embodiment, as an alternative connection mode, the housing 311 is in a tubular structure, the knob 34 is sleeved on an outer side surface of the housing 311 and can coaxially rotate outside the housing 311, and the outer cover 312 is in a ring-shaped structure having a passage, and is sealingly connected to an end of the housing 311 by a form such as a sealing ring and a pressing block.
The inner side of the rotary handle 34 is provided with an internal thread, the supporting slide way 36 is mounted on the rotary handle, the tooth block 35 is sleeved on the supporting slide way in an axially sliding manner, the inner side of the tooth block 35 is provided with a limiting through groove matched with a limiting strip on the outer side of the supporting slide way 36 to ensure that the tooth block 35 cannot rotate and can only slide along the limiting through groove, the outer side of the tooth block 35 is provided with an external thread matched with the internal thread, the first sliding block 32 is sleeved on the supporting slide way in a sliding manner, and the tooth block 35 can drive the first sliding block 32 to slide.
When the user rotates the knob 34, the threads between the knob 34 and the tooth block 35 move relatively, and the tooth block 35 cannot rotate and can only slide along the limit through groove, so that a movement mechanism of a screw-nut pair is formed, so that the tooth block 35 slides along the first slideway, specifically, when the tooth block 35 moves proximally, the corresponding bending wire 33 on the first slider 32 is pulled proximally, the corresponding inner sheath 13 or outer sheath 14 is pulled and bent, and when the tooth block 35 moves distally, the corresponding bending wire 33 on the first slider 32 is loosened under the action of the elasticity of the inner core, and the inner sheath 13 or outer sheath 14 tends to straighten.
The telescopic assembly 40 comprises a second shell 41 and a second sliding block 42, a second slideway is arranged in the second shell 41, the second sliding block 42 is fixedly connected with the support pipe 12, and the second sliding block 42 can drive the support pipe 12 to slide along the second slideway outside the inner core 11.
The specific structure of the second housing 41 and the second slider 42 may be similar to the connection mode that the turning handle similar to the bending handle rotates to drive the tooth block to slide, or may be a connection mode that two coaxial sliding sleeves pull, in this example, the former scheme is preferred; the main function of the telescopic assembly 40 is to drive the support tube 12 to move axially, and thus drive the heart valve stent connected to the fixed block 24 to slide axially.
In the preferred embodiment of the present application, the second housing 41 is located at the proximal end of the inner core 11, and the detachable member 25 is a fixed cover mounted on the proximal end of the second housing 41, and the fixed cover and the second housing are fixed by a buckle or a rotational bayonet limit, and when the fixed cover is rotated, the fixed cover can be separated from the second housing 41, thereby releasing the heart valve support 200.
In order to place the interference between the telescopic assembly 40 and the bending handle 30, in this embodiment, there is also a stopper 50 detachably mounted between the telescopic assembly 40 and the bending handle 30.
Example two
As shown in fig. 8, the present application provides a delivery system comprising a heart valve stent 200 and the delivery device 100 disclosed in the above embodiments.
As shown in fig. 10 to 12, the heart valve stent 200 includes a stent body 201, a second release member (not shown), a positioning member 203, and a first release member 204.
The support body 201 can be compressed along the radial direction and accommodated in the accommodating cavity or the capsule cavity, the positioning piece 203 is connected to one end of the support body 201 and can be folded towards the other end of the support body naturally without being influenced by external force, and the first release piece 204 is connected to the distal end of the support body 201 and can be detachably connected with the fixed block 24; the proximal end of the holder body 201 is detachably connected to the arm 222.
In the preferred embodiment of the present application, the positioning member 203 is mounted at the proximal end of the support body 201, and can be folded towards the distal end naturally under the condition of no external force, when the support body 201 is received in the capsule cavity in the capsule 23, the end of the capsule 23 near the proximal end pushes the positioning member 203 to fold towards the proximal end naturally until the positioning member 203 forms a compressed form, and the positioning member 203 does not need to be folded reversely manually, so that the mounting process is simplified, the stability of the compressed form of the positioning member 203 is ensured effectively, and the position accuracy of the positioning member 203 when released is ensured.
In some embodiments, the support body 201 is defined by an annular grid structure, the ends of the support arms 222 are connected with the grid side edges of the proximal end of the support body 201 in a hooking manner, and the hooking portions are released by pulling the support arms 222, so that the proximal end of the support body 201 can be released.
In this embodiment, a second release member is connected to the proximal end of the holder body 201, wherein the second release member is detachably connected to the arm 222.
Specifically, in the present embodiment, as shown in fig. 10 and 12, the end of the arm 222 has a stop ring 2221, the second release member has a coil 2021 that can pass through the stop ring 2221 from outside to inside, and the distal end of the stop member 21 can clamp the connection between the coil 2021 and the stop ring 2221 by passing through the inside of the coil 2021, so as to limit the separation of the coil 2021 and the stop ring 2221.
As a preferred embodiment, the fixing member 22 has a plurality of support arms 222, the number of the second release members is equal to the number of the support arms 222, the distal end of the limiting member 21 can be sequentially threaded through a plurality of coils 2021, for example, in a specific use condition, the number of the support arms 22 and the number of the second release members are 3, the distal end of the limiting member 21 sequentially passes through three coils 2021, when the proximal end of the bracket body 201 needs to be released, the pulling and releasing member 25 drives the limiting member 21 to be pulled out from the three coils, and the coils 2021 are separated from the limiting ring 2221 under tension, so as to complete the proximal end release of the bracket.
As another alternative embodiment, the number of the support arms 22 and the number of the second release members are 3, the number of the limiting members 21 is also 3, the distal ends of the 3 limiting members 21 are correspondingly arranged in the three coils 2021 in a penetrating manner, when the proximal end of the support body 201 needs to be released, the pulling and releasing member 25 simultaneously drives the three limiting members 21 to be pulled out of the three coils, and the three second release members are simultaneously released, so that the rapid and stable release of the support body 201 is ensured.
Preferably, as shown in fig. 9 and 12, the fixed block 24 has a limit groove 24a thereon, and the first release member 204 has a T-shaped portion that mates with the limit groove 24 a.
It will be appreciated that in some embodiments, the limiting groove 24a may be an open groove disposed along the radial direction of the support body 201, at this time, the T-shaped portion is directly fastened in the notch of the open groove from the outer side portion of the fixing block 24, the pressure of the inner wall of the accommodating cavity or the capsule cavity ensures the stable connection between the limiting groove 24a and the T-shaped portion, when released, the inner wall of the accommodating cavity or the capsule cavity no longer covers the opening of the limiting groove 24a, and under the action of self-expanding tension, the T-shaped portion expands outwards along with the support body 201 and is separated from the limiting groove 24 a; in other embodiments, the slot may be an axially disposed slot, where the opening of the slot is disposed towards the proximal end, and the T-shaped portion is inserted into the slot from the proximal end surface of the fixed block, and the pressure passing through the inner wall of the accommodating cavity or the capsule cavity includes a tendency of the T-shaped portion to extend distally, so as to be stably inserted into the slot, and when released, the proximal end of the bracket body 201 has a tendency of stretching under self-expanding tension, so as to drive the T-shaped portion to be drawn out from that slot and separate from the limiting slot.
Similarly, the detachable connection scheme may also be that the fixing block 24 is provided with a limiting protrusion, the first release member is provided with an annular portion detachably connected with the limiting protrusion, and the detachable connection between the fixing block 24 and the first release member 204 is realized through the sleeving connection between the annular portion and the limiting protrusion, which is not described herein.
The foregoing is only illustrative of the present invention and is not to be construed as limiting thereof, but rather as various modifications, equivalent arrangements, improvements, etc., within the spirit and principles of the present invention.
Claims (15)
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210474024.5A CN116407363B (en) | 2022-04-29 | 2022-04-29 | A delivery device and delivery system for an interventional heart valve stent |
| EP23795664.4A EP4516264A4 (en) | 2022-04-29 | 2023-04-28 | DELIVERY SYSTEM FOR INTERVENTIONAL HEART VALVE STENTS |
| JP2024564528A JP2025514441A (en) | 2022-04-29 | 2023-04-28 | Interventional Heart Valve Stent Delivery System |
| PCT/CN2023/091868 WO2023208232A1 (en) | 2022-04-29 | 2023-04-28 | Delivery system for interventional heart valve stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210474024.5A CN116407363B (en) | 2022-04-29 | 2022-04-29 | A delivery device and delivery system for an interventional heart valve stent |
Publications (2)
| Publication Number | Publication Date |
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| CN116407363A CN116407363A (en) | 2023-07-11 |
| CN116407363B true CN116407363B (en) | 2024-11-22 |
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| CN202210474024.5A Active CN116407363B (en) | 2022-04-29 | 2022-04-29 | A delivery device and delivery system for an interventional heart valve stent |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117122448B (en) * | 2023-08-31 | 2025-03-07 | 佰仁医疗(江苏)有限公司 | Heart valve transporter |
| CN119632730B (en) * | 2023-09-18 | 2025-11-18 | 深圳市健心医疗科技有限公司 | Connecting devices, tubular components and conveying systems |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN210811767U (en) * | 2019-06-27 | 2020-06-23 | 宁波健世生物科技有限公司 | Valve conveying system capable of reversely bending |
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| US8652202B2 (en) * | 2008-08-22 | 2014-02-18 | Edwards Lifesciences Corporation | Prosthetic heart valve and delivery apparatus |
| US10856978B2 (en) * | 2010-05-20 | 2020-12-08 | Jenavalve Technology, Inc. | Catheter system |
| US9414915B2 (en) * | 2010-09-24 | 2016-08-16 | Symetis Sa | Stent valve, delivery apparatus and method therefor |
| EP2950752B1 (en) * | 2013-02-04 | 2022-07-27 | Twelve, Inc. | Hydraulic delivery systems for prosthetic heart valve devices |
| US10149758B2 (en) * | 2014-04-01 | 2018-12-11 | Medtronic, Inc. | System and method of stepped deployment of prosthetic heart valve |
| JP6829692B2 (en) * | 2015-03-20 | 2021-02-10 | イェーナヴァルヴ テクノロジー インコーポレイテッド | Heart valve prosthesis delivery system and method for delivering the heart valve prosthesis through the introducer sheath |
| CN104758092B (en) * | 2015-04-20 | 2018-09-18 | 上海纽脉医疗科技有限公司 | A kind of insertion type artificial cardiac valve transport system |
| WO2018165356A1 (en) * | 2017-03-10 | 2018-09-13 | St. Jude Medical, Cardiology Division, Inc. | Transseptal mitral valve delivery system |
| CN108371570B (en) * | 2017-10-24 | 2023-10-31 | 杭州启明医疗器械股份有限公司 | Interventional heart valve recyclable conveying system with stable operation |
| CN210330826U (en) * | 2018-01-07 | 2020-04-17 | 苏州杰成医疗科技有限公司 | Heart valve prosthesis |
| CA3143260A1 (en) * | 2019-06-14 | 2020-12-17 | Datascope Corp. | Intra-aortic balloon pump catheter and sheath seal assembly |
| CN214128920U (en) * | 2020-10-12 | 2021-09-07 | 宁波健世科技股份有限公司 | Valve conveying system with movable bending section |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN210811767U (en) * | 2019-06-27 | 2020-06-23 | 宁波健世生物科技有限公司 | Valve conveying system capable of reversely bending |
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