CN117017572A - Split absorbable artificial intervention heart valve system - Google Patents
Split absorbable artificial intervention heart valve system Download PDFInfo
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- CN117017572A CN117017572A CN202310793499.5A CN202310793499A CN117017572A CN 117017572 A CN117017572 A CN 117017572A CN 202310793499 A CN202310793499 A CN 202310793499A CN 117017572 A CN117017572 A CN 117017572A
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 69
- 230000008093 supporting effect Effects 0.000 claims abstract description 58
- 210000002837 heart atrium Anatomy 0.000 claims abstract description 8
- 230000001502 supplementing effect Effects 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 12
- 239000000835 fiber Substances 0.000 claims description 11
- 238000005286 illumination Methods 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 3
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 3
- 229920001610 polycaprolactone Polymers 0.000 claims description 3
- 239000004632 polycaprolactone Substances 0.000 claims description 3
- 239000004626 polylactic acid Substances 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims description 2
- 238000002324 minimally invasive surgery Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 description 43
- 230000000694 effects Effects 0.000 description 21
- 238000002513 implantation Methods 0.000 description 17
- 210000004204 blood vessel Anatomy 0.000 description 11
- 230000006870 function Effects 0.000 description 11
- 238000011282 treatment Methods 0.000 description 9
- 230000000004 hemodynamic effect Effects 0.000 description 8
- 230000001681 protective effect Effects 0.000 description 8
- 230000000747 cardiac effect Effects 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 238000011369 optimal treatment Methods 0.000 description 4
- 238000005457 optimization Methods 0.000 description 4
- 230000001575 pathological effect Effects 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 238000011269 treatment regimen Methods 0.000 description 4
- 238000011084 recovery Methods 0.000 description 3
- 239000000227 bioadhesive Substances 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000005297 material degradation process Methods 0.000 description 2
- 238000004064 recycling Methods 0.000 description 2
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 2
- 241001631457 Cannula Species 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- 239000003364 biologic glue Substances 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 230000002612 cardiopulmonary effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000000696 magnetic material Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 230000002966 stenotic effect Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000005166 vasculature Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—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
- A61F2/2463—Implants forming part of the valve leaflets
-
- 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
- A61F2/2412—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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a split absorbable artificial intervention heart valve system, which relates to the technical field of medical equipment, and specifically comprises a conveying catheter, wherein a first storage area is arranged on the conveying catheter, and a support piece is stored in the first storage area; a guide catheter arranged to connect the delivery catheter first end, the guide catheter having a second receiving area arranged thereon, the second receiving area configured to receive a heart valve body; a power system for moving the support from the first receiving area into the external environment and the heart valve body from the second receiving area into the external environment; the external environment is an atrium and/or a ventricle, the connecting part is arranged on the supporting piece, and the heart valve body and the connecting part on the supporting piece are arranged in a matching way, so that compared with the prior art, the safety of minimally invasive surgery can be improved by the scheme disclosed by the invention.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a split absorbable artificial intervention heart valve system.
Background
Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of heart valve leaflets may be treated with heart valve replacement surgery. Traditional surgical valve replacement procedures require sternotomy and cardiopulmonary bypass, which can cause serious trauma and discomfort to the patient. Traditional surgical valve procedures may also require long recovery and may lead to life threatening complications.
An alternative to traditional surgical valve replacement surgery is to use minimally invasive techniques to deliver implantable medical devices. For example, prosthetic heart valves can be delivered percutaneously and transluminally to the implantation site. In such methods, the prosthetic heart valve may be compressed or crimped onto a delivery cannula for insertion into the vasculature of a patient; advancing to an implantation site; and re-expanded for deployment at the implantation site. Devices commonly used to access blood vessels and other locations within the body and to perform various functions at these locations are medical or delivery cannulas adapted to deliver and deploy medical devices such as prosthetic heart valves, stent grafts, and stents to selected target sites within the body. Such medical devices are typically releasably carried within the distal region of the delivery cannula in a radially compressed delivery state or configuration at the time when the cannula is directed to the target treatment/deployment site, but during actual surgical procedures, after releasing the valve, it may be found that the heart of the patient is not available for valve placement, which is difficult if stent and valve retrieval is desired, due to the complexity of the individual patient's situation.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a split absorbable artificial intervention heart valve system.
The invention is realized by the following technical scheme: the invention discloses a split absorbable artificial intervention heart valve system, which comprises:
a conveying pipe, wherein a first accommodating area is arranged on the conveying pipe, and a supporting piece is accommodated in the first accommodating area;
a guide catheter arranged to connect the delivery catheter first end, the guide catheter having a second receiving area arranged thereon, the second receiving area configured to receive the heart valve body;
a power system for moving the support from the first receiving area into the external environment and the heart valve body from the second receiving area into the external environment;
wherein the external environment is atrium and/or ventricle, the connecting part is arranged on the supporting piece, and the joint part is arranged on the heart valve body and the connecting part on the supporting piece in a matching way.
The delivery catheter is used for delivering the support and the heart valve to a target position, the delivery catheter has certain rigidity, the stent and the heart valve can be pushed in, meanwhile, the inner diameter of the delivery catheter can be capable of accommodating the contracted stent, the specific release process of the support is not limited, the first accommodating area can be arranged as a protective sheath, the protective sheath is a sleeve used for protecting the support and surrounding tissues and is made of soft and smooth materials, the damage of the support to the surrounding tissues during implantation can be reduced, the support can be released through a power system, the power system is used for enabling the protective sheath and the support to fall off, an operator can apply force to the protective sheath or the support through a traction wire, and the whole falling off process is completed.
For the guiding catheter of the present invention, which is used for guiding the whole delivery system to the target position through the blood vessel, the guiding catheter also has good flexibility and operability so as to facilitate navigation in the blood vessel, and the guiding catheter also accommodates the heart valve body, the release of the heart valve body is also performed through the power system, and the heart valve body and the support piece in the present invention are respectively delivered into the heart, and the specific procedures can be as follows:
s1, inserting a guiding catheter into a blood vessel of a patient through X-ray or ultrasonic guiding, and navigating the guiding catheter to a target position;
s2: after the delivery catheter reaches the target position, pushing the support out of the first storage area by operating the power system;
s3: after the support is completely pushed out, the support is expanded by injecting liquid or gas into the air bag on the support, so that the support is fixed at a target position;
s4: placing the prosthetic heart valve at the front end of the guide catheter at the other end, and moving the guide catheter to a position to the support;
s5: after reaching the target position, pushing the valve out of the second storage area by operating the power system, and butting the valve with the support piece through the connecting structure to finish implantation of the valve;
s6: after confirming that the absorbable stent and prosthetic heart valve are properly positioned and functioning properly, the delivery catheter and guide catheter are gradually withdrawn.
For the above-mentioned operation procedure, the heart valve operation is performed by implanting the support member in the heart valve body, the stability of the valve main body is higher in the operation process, the stability of the valve main body can be better considered in the design by separately implanting the valve and the support member, the influence on the valve main body in the deformation process is reduced, in some existing integrated valve support designs, the valve and the support are tightly combined together, in the implantation process, the support may need to undergo a certain degree of deformation to adapt to the space in the heart, the deformation may have a certain influence on the valve main body, so that the valve function is damaged, and the valve main body and the support member are separately implanted in the invention, so that the stability of the valve main body can be better considered in the design, the influence on the valve main body in the deformation process is reduced, for example, the material and the structure of the valve main body can be optimized, so that the stability and the tolerance of the valve main body in the deformation process are improved; furthermore, the support and the valve can be optimized independently in the present invention: the valve and the bracket are separately implanted, so that the characteristics of the valve and the bracket can be respectively optimized, the overall performance and effect are improved, for example, the bracket can be customized according to the heart structure and pathological conditions of a patient, and better supporting and fixing effects are provided; the valve can be optimized according to the hemodynamic requirements of a patient so as to improve the functional performance of the valve, and the independent optimization can enable the valve and the bracket to achieve better performance in respective functional aspects, so that the overall treatment effect is improved; in addition, there may be better personalized treatments: the valve and the stent are separately implanted, and the proper valve and the stent can be selected according to the specific situation of a patient so as to achieve the optimal treatment effect. For example, for some patients, a specially designed stent may be required to accommodate their cardiac structure, while other patients may require a valve with specific functions to meet their hemodynamic requirements. This split mounting approach allows for more flexibility in meeting the needs of different patients, providing a more personalized treatment regimen.
Preferably, the material of the partial area of the support piece is polylactic acid or polycaprolactone, the support piece is made of biodegradable materials, the support piece has good biocompatibility and degradability, the support is gradually degraded within a period of time after implantation and finally is completely absorbed by a body, the foreign matters in a patient are reduced, for the support piece, the material degradation rates of different areas are different, the support piece is gradually reduced in the degradation process instead of suddenly losing the support effect, after the support piece is completely degraded, the valve is well combined with surrounding tissues, and the combination of the valve and the surrounding tissues can provide sufficient support.
Preferably, the support comprises a plurality of annular support members arranged along a first path, the first path being the path of the junction of the atrium and ventricle where the support is placed;
wherein the support member includes peak areas and valley areas alternately arranged, the support member having a compressed state and an expanded state, an end face outer wall dimension of the support member being smaller than an inner wall dimension of the first receiving area when the support member is in the compressed state, and an end face inner wall dimension of the support member being larger than an outer wall dimension of the first receiving area when the support member is in the expanded state;
the area of the valley region in the expanded state is larger than the area of the valley region in the compressed state; by changing the structure of the plurality of support members, the whole structure of the support members is in a compressed state or an expanded state, and a proper mode is purposely selected.
Preferably, the support further comprises an air bag, the support member being arranged at a periphery of the air bag;
the air bag comprises a first state and a second state, the volume of the air bag in the first state is larger than that of the air bag in the second state, and the air bag surrounds and restrains to radially support the supporting member in the expanded state or to deliver the supporting member in the compressed state;
specifically, the invention expands the volume of the balloon to bring the support member into an expanded state, the support and balloon are pre-assembled prior to implantation in the heart, and after reaching the target site, a liquid or gas is injected into the balloon through the delivery catheter to inflate the balloon and expand the support. The stent will then, in its expanded state, lie against the tissue surrounding the heart valve to ensure that the valve can be subsequently secured stably.
Preferably, the conveying conduit comprises a first light emergent region, and the first accommodating region is arranged on one side of the first light emergent region;
the support member is made of memory metal, when the first light emitting area emits light to act on the support member, the support member is converted into a compressed state from an expanded state, specifically, when the support is found to be unsuitable for a patient in the operation process, the support member in the expanded state can be recycled through the first light emitting area, and the specific process comprises the following steps:
moving the position of the first light emergent region to enable the first light emergent region to be surrounded by the support piece in an expanded state;
b: electrifying the first light-emitting area to enable the first light-emitting area to emit light rays with specific wavelengths, wherein the light rays act on the support piece in an expanded state;
c: the support piece is made of memory alloy, and under the action of light with specific wavelength, the support piece is in a compressed state and is attached to the surface of the first light emitting area;
d: and (3) moving the conveying catheter to move the heart valve system outside the blood vessel, continuously maintaining the light emitting effect of the first light emitting area in the process of moving the conveying catheter, and completing the recovery of the supporting piece.
For the procedure of recovering the support, the light with a specific wavelength can be ultraviolet light with a wavelength of-micron, and because the valve body and the support are respectively released and assembled in the invention, when a risk problem is found, the artificial heart valve is also arranged at the front end of the guide catheter at the other end, so that the whole heart valve system can be removed from the heart by only recovering the support, and the technical difficulty is relatively small.
Preferably, for easy understanding, the present invention discloses a specific structure of a first light emitting area, where the first light emitting area includes:
the two light guide pieces are semi-cylindrical; the two light guide pieces are spliced to form a cylinder;
the splicing surfaces of the two light guide pieces are covered on two sides of the light reflecting layer;
the light inlet side of the light guide piece is provided with the lighting unit, and the curved side edge of the light guide piece forms a light outlet surface;
the light emitting surface of the light guide member is a supporting surface, the air bag is supported by the light emitting surface, the light emitted by the lighting unit is conducted through the light guide member in the first light emitting area, and the light emitting surface of the light guide member also has a partial reflection effect, so that the light emitting layer is further arranged for recycling the light, and the light entering the light guide member from the outside and the light reflected by the light guide member are recycled through the light reflecting layer.
Preferably, the light emitting surface of the light guide member comprises a first end close to the lighting unit and a second end far away from the lighting unit, and the surface edge area of the light emitting surface close to the first end and/or the second end is provided with a protruding member;
the protruding piece comprises a reflecting area, the reflecting surface of the reflecting area reflects incident light towards the center of the supporting piece, for the protruding piece in the invention, the protruding piece protrudes outwards relative to the light emitting surface, when the supporting piece is in a compressed state, the protruding block extrudes the inner wall of the supporting piece, further friction force between the supporting piece and the first light emitting area is increased, accidental falling of the supporting piece is prevented when the supporting piece moves in a blood vessel, in addition, the protruding piece also has a reflecting function, part of light cannot be reflected into the light guide piece after being reflected by the supporting piece due to the edge position of the light guide piece, or does not enter the light guide piece, and therefore the brightness of the edge area of the supporting piece is smaller than that of other areas.
Preferably, in order to further increase the amount of light irradiated to the inner wall of the support, a light guide fiber is arranged inside the conveying conduit, a light supplementing region is arranged on the other side of the first light emitting region, and the light guide fiber extends into the light supplementing region; part of the light supplementing region acts on the support member in the expanded state, and then through the arrangement of the light supplementing region, the light of other regions can also be absorbed by the support piece, and specifically, the light supplementing region comprises: an enclosing body enclosing the light guide fiber; the opening groove is formed in the surface of the surrounding body; the first medium fills the notch so as to enable the surrounding body to be in a sealing state; the refractive index of the first medium is larger than that of air, light emitted by the light guide fiber is reflected on the inner wall of the surrounding body, and then is emitted from the position of the notch, the first medium is filled in the position of the notch, the light path of the light passing through the first medium is changed, and the light is refracted to the periphery of the side wall of the first light emitting area and acts on the surface of the support piece.
The invention discloses a split absorbable artificial intervention heart valve system, which is compared with the prior art:
the heart valve system adopts a mode of implanting the support piece into the heart valve body firstly to perform heart valve operation, the stability of the valve main body is higher in the operation process, the stability of the valve main body can be better considered in the design by separately implanting the valve and the support piece, the influence on the valve main body in the deformation process is reduced, in some existing integrated valve support designs, the valve and the support are tightly combined together, in the implantation process, the support possibly needs to undergo a certain degree of deformation to adapt to the space in the heart, the deformation possibly has a certain influence on the valve main body, the valve function is damaged, and the valve main body and the support piece are separately implanted, so that the stability of the valve main body can be better considered in the design, the influence on the valve main body in the deformation process is reduced, for example, the material and the structure of the valve main body can be optimized, and the stability and the tolerance of the valve main body in the deformation process are improved; furthermore, the support and the valve can be optimized independently in the present invention: the valve and the bracket are separately implanted, so that the characteristics of the valve and the bracket can be respectively optimized, the overall performance and effect are improved, for example, the bracket can be customized according to the heart structure and pathological conditions of a patient, and better supporting and fixing effects are provided; the valve can be optimized according to the hemodynamic requirements of a patient so as to improve the functional performance of the valve, and the independent optimization can enable the valve and the bracket to achieve better performance in respective functional aspects, so that the overall treatment effect is improved; in addition, there may be better personalized treatments: the valve and the stent are separately implanted, and the proper valve and the stent can be selected according to the specific situation of a patient so as to achieve the optimal treatment effect. For example, for some patients, a specially designed stent may be required to accommodate their cardiac structure, while other patients may require a valve with specific functions to meet their hemodynamic requirements. This split mounting approach allows for more flexibility in meeting the needs of different patients, providing a more personalized treatment regimen.
Drawings
FIG. 1 is a schematic illustration of a heart valve system in accordance with an embodiment of the present invention;
FIG. 2 is a schematic illustration of an embodiment of a heart valve system in a heart;
FIG. 3 is a schematic view showing an appearance of a supporting member in one state in an embodiment;
FIG. 4 is a schematic view showing an external appearance of a support member in another state in an embodiment;
FIG. 5 is a schematic view of a first state of a support member according to an embodiment;
FIG. 6 is a schematic diagram illustrating a connection between a first light emitting region and a light compensating region according to an embodiment;
FIG. 7 is a schematic view of a second state of the support member according to an embodiment;
FIG. 8 is an enlarged view of a portion of FIG. 7 at position A;
fig. 9 is a schematic diagram of a valve structure for completing implantation in an embodiment.
Description of the embodiments
The following describes in detail the examples of the present invention, which are implemented on the premise of the technical solution of the present invention, and detailed embodiments and specific operation procedures are given, but the scope of protection of the present invention is not limited to the following examples.
As shown in fig. 1, the invention is realized by the following technical scheme: the invention discloses a split absorbable artificial intervention heart valve system, which comprises: a conveying conduit 1, wherein a first receiving area is arranged on the conveying conduit 1, and a supporting piece is received in the first receiving area; a guide catheter 2, the guide catheter 2 being arranged to connect to the first end of the delivery catheter 1, the guide catheter 2 being arranged with a second receiving area, the second receiving area being configured to receive the heart valve body;
a power system 3, the propulsion system 3 being used to move the support from the first receiving area into the external environment and the heart valve body from the second receiving area into the external environment; wherein the external environment is atrium and/or ventricle, the connecting part is arranged on the supporting piece, and the joint part is arranged on the heart valve body and the connecting part on the supporting piece in a matching way.
For the delivery catheter 1 of the present invention, which is used for delivering the support and the heart valve to the target site, as shown in fig. 2, the target site may be a site where the atrium and the ventricle are combined, the delivery catheter has a certain rigidity, so that the stent and the heart valve may be pushed in, meanwhile, the inner diameter of the delivery catheter may be capable of accommodating the contracted stent, for the specific release process of the support, without specific limitation, the first accommodating area may be arranged as a protective sheath, the protective sheath of the present invention is a sleeve for protecting the support and the surrounding tissue, and is made of a soft and smooth material, so that damage to the surrounding tissue during implantation of the support may be reduced, the support may be released by the power system 3, the power system 3 is used for a device for releasing the protective sheath from the support, and an operator may apply a force to the protective sheath or the support through a traction wire, so as to complete the whole release process.
For the guiding catheter 2 of the present invention, which is used for guiding the whole delivery system to the target position through the blood vessel, the guiding catheter also has good flexibility and operability so as to facilitate navigation in the blood vessel, and the guiding catheter 2 also accommodates the heart valve body, the release of the heart valve body is also performed by the power system 3, and the heart valve body and the support piece of the present invention are respectively delivered into the heart, and the specific procedures can be as follows:
s1, inserting a guiding catheter 2 into a blood vessel of a patient through X-ray or ultrasonic guiding, and navigating the guiding catheter to a target position, wherein the state is shown in figure 2;
s2: after the delivery catheter reaches the target position, pushing the support out of the first receiving area by operating the power system 3;
s3: after the support is completely pushed out, the support is expanded by injecting liquid or gas into the air bag on the support, so that the support is fixed at a target position;
s4: placing the prosthetic heart valve at the front end of the guide catheter at the other end, and moving the guide catheter to a position to the support;
s5: after reaching the target position, pushing the valve out of the second storage area by operating the power system 3, and butting the valve with the support piece through the connecting structure to finish implantation of the valve, wherein the region a of the implanted valve is the support piece and the region b is the artificial heart valve body as shown in fig. 9;
s6: after confirming that the absorbable stent and prosthetic heart valve are properly positioned and functioning properly, the delivery catheter and guide catheter are gradually withdrawn.
The above-mentioned joint can be mechanically locked, so that the valve and the stent can be locked by a simple operation after implantation by a mechanical locking structure. For example, a slot-in-slot structure may be designed, the edge of the valve is inserted into the slot of the stent, and then the valve is fixed on the stent by rotating or pushing and pulling; or magnetic adsorption, the magnetic material is arranged at the connecting part of the valve and the bracket, so that the valve and the bracket can be automatically adsorbed together when approaching; or can also be bioadhesive, utilize bioadhesive material (such as biological glue) to bond valve and support together, the invention does not make the sole limit, for the above-mentioned operation procedure, adopt the way of implanting the support piece in the heart valve body first, the valve main body stability is higher in the operation process of the invention, through separately implanting valve and support piece, can consider the stability of the valve main body better in the design, reduce the influence on valve main body in the course of deformation, in some existing integral valve support designs, valve and support are closely combined together, in the course of implantation, the support may need to undergo certain deformation in order to adapt to the space in heart, this deformation may produce certain influence on valve main body, cause valve function to be impaired, and the invention implants valve main body and support piece separately, can consider the stability of valve main body better in the design, reduce the influence on valve main body in the course of deformation, for example, can optimize to material and structure of valve main body, in order to improve its stability and tolerance in the course of deformation; furthermore, the support and the valve can be optimized independently in the present invention: the valve and the bracket are separately implanted, so that the characteristics of the valve and the bracket can be respectively optimized, the overall performance and effect are improved, for example, the bracket can be customized according to the heart structure and pathological conditions of a patient, and better supporting and fixing effects are provided; the valve can be optimized according to the hemodynamic requirements of a patient so as to improve the functional performance of the valve, and the independent optimization can enable the valve and the bracket to achieve better performance in respective functional aspects, so that the overall treatment effect is improved; in addition, there may be better personalized treatments: the valve and the stent are separately implanted, and the proper valve and the stent can be selected according to the specific situation of a patient so as to achieve the optimal treatment effect. For example, for some patients, a specially designed stent may be required to accommodate their cardiac structure, while other patients may require a valve with specific functions to meet their hemodynamic requirements. This split mounting approach allows for more flexibility in meeting the needs of different patients, providing a more personalized treatment regimen.
In one embodiment, the material of the partial area of the supporting piece is polylactic acid or polycaprolactone, the supporting piece is made of biodegradable materials, the supporting piece has good biocompatibility and degradability, the stent is gradually degraded within a period of time after implantation and is finally completely absorbed by a body, foreign matters in a patient are reduced, for the supporting piece, the material degradation rates of different areas are different, the supporting piece is gradually reduced to support the valve in the degradation process instead of suddenly losing the supporting effect, after the stent is completely degraded, the valve is well combined with surrounding tissues, and the combination of the valve and the surrounding tissues can provide sufficient support.
In one embodiment, as shown in fig. 3 and 4, the support comprises a plurality of annular support members arranged along a first path, the first path being the path of the junction of the atrium and ventricle where the support is placed; as in fig. 3 and 4, the a region is the valley region and the b region is the peak region, and the morphology of the support member can be changed by the alternating arrangement of the peak and valley regions.
Wherein the supporting member includes peak areas and valley areas alternately arranged, the supporting member has a compressed state and an expanded state, fig. 4 shows that the outer wall size of the end face of the supporting member is smaller than the inner wall size of the first receiving area when the supporting member is in the compressed state, and fig. 3 shows that the inner wall size of the end face of the supporting member is larger than the outer wall size of the first receiving area when the supporting member is in the expanded state;
the area of the valley region in the expanded state is larger than the area of the valley region in the compressed state; by changing the structure of the plurality of support members, the whole structure of the support members is in a compressed state or an expanded state, and a proper mode is purposely selected.
In one embodiment, the support further comprises an air bag, the support member being arranged at a periphery of the air bag;
the air bag comprises a first state and a second state, the volume of the air bag in the first state is larger than that of the air bag in the second state, and the air bag surrounds and restrains to radially support the supporting member in the expanded state or to deliver the supporting member in the compressed state;
specifically, the present invention allows the support member to be in an expanded state by expanding the volume of the balloon, the support and balloon are pre-assembled prior to implantation in the heart, and after reaching the target site, the balloon can be inflated and expanded by injecting a liquid or gas into the balloon through the delivery catheter 1. The stent will then be in close proximity to the tissue surrounding the heart valve in the expanded state to ensure that the valve can be subsequently secured stably, as shown in fig. 5, with the first receiving region disposed in the D1 region and the balloon disposed in the D1 region.
In one embodiment, as shown in a region D2 in fig. 5, the conveying pipe 1 includes a first light emitting region, and the first receiving region is disposed at one side of the first light emitting region;
the support member is made of memory metal, when the first light emitting area emits light to act on the support member, the support member is converted into a compressed state from an expanded state, specifically, when the support is found to be unsuitable for a patient in the operation process, the support member in the expanded state can be recycled through the first light emitting area, and the specific process comprises the following steps:
moving the position of the first light emergent region to enable the first light emergent region to be surrounded by the support piece in the expanded state, as shown in fig. 7;
b: electrifying the first light-emitting area to enable the first light-emitting area to emit light rays with specific wavelengths, wherein the light rays act on the support piece in an expanded state;
c: the support piece is made of memory alloy, and under the action of light with specific wavelength, the support piece is in a compressed state and is attached to the surface of the first light emitting area;
d: and (3) moving the conveying catheter to move the heart valve system outside the blood vessel, continuously maintaining the light emitting effect of the first light emitting area in the process of moving the conveying catheter, and completing the recovery of the supporting piece.
For the above procedure of recovering the support, the specific wavelength of light may be 0.05-1 μm, and since the valve body and the support are released and reassembled separately in the present invention, when a risk problem is found, the artificial heart valve is still placed at the front end of the guide catheter at the other end, so that the whole heart valve system can be removed from the heart by recovering only the support, which is relatively less difficult in technology.
For convenience of understanding, the present invention discloses a specific embodiment of a first light emitting area, as shown in fig. 6, where the first light emitting area includes: the two light guide pieces 11, the light guide pieces 11 are semi-cylindrical; the two light guide pieces 11 are spliced to form a cylinder; the light reflecting layer 12, the splicing surfaces of the two light guide pieces 11 are covered on two sides of the light reflecting layer 12; the illumination unit 13, the light incident side of the light guide 11 is arranged with the illumination unit 13, and the curved side of the light guide 11 forms a light emitting surface.
The light emitting surface of the light guiding member 11 is a supporting surface, and for the first light emitting area, the light emitted by the lighting unit 13 is conducted through the light guiding member 11, and since the light emitting surface of the light guiding member also has a partial reflection effect, for recycling the light, the light emitting layer 12 is further disposed, and the light entering the light guiding member 11 from the outside and the light reflected by the light guiding member 11 itself are recycled through the light reflecting layer.
In one embodiment, as shown in fig. 8, the light emitting surface of the light guide 11 includes a first end close to the lighting unit 13 and a second end far away from the lighting unit 13, and the protruding member 14 is disposed on the surface edge area of the light emitting surface close to the first end and/or the second end;
the protruding member 14 includes a reflective area, the reflective surface of the reflective area reflects incident light toward the center of the supporting member, for the protruding member in the present invention, it protrudes outwards relative to the light emitting surface, and then when the supporting member is in a compressed state, the protruding block extrudes the inner wall of the supporting member, and further increases friction force between the supporting member and the first light emitting area, preventing the supporting member from accidentally falling off when moving in the blood vessel, in addition, the protruding member further has a reflective function, because the edge of the light guiding member 11 is located, part of light cannot be reflected into the light guiding member 11 again after being reflected by the supporting member, or does not enter into the light guiding member, and further causes the brightness of the edge area of the supporting member to be smaller than other areas, therefore, by arranging the protruding member 14, the light path of the light reflected by the supporting member to the edge area of the light guiding member 11 can be changed, and is continuously used toward the supporting member, and in particular, the reflective area of the protruding member 14 is concavely arranged.
In order to further increase the amount of light irradiated to the inner wall of the support, as shown in fig. 6 and 7, a light guide fiber is disposed inside the conveying conduit 1, and a light supplementing region is disposed at the other side of the first light emitting region, and the light guide fiber extends into the light supplementing region; part of the light supplementing region acts on the support member in the expanded state, and then through the arrangement of the light supplementing region, the light of other regions can also be absorbed by the support piece, and specifically, the light supplementing region comprises: an enclosing body 15, the enclosing body 15 enclosing the light guide fiber; the opening groove is formed on the surface of the enclosing body 15; a first medium 16 filling the slit to place the enclosure 15 in a sealed state; the refractive index of the first medium is greater than that of air, light rays at the position of the notch are refracted towards the direction of the supporting piece, the situation that part of light emitted from the position of the notch cannot act on the supporting piece is avoided, light emitted by the light guide fiber is reflected on the inner wall of the surrounding body 15 and then emitted from the position of the notch, the position of the notch is filled with the first medium, the light path of the light rays passing through the first medium is changed, and the light rays are refracted to the periphery of the side wall of the first light emitting area and act on the surface of the supporting piece.
In summary, the heart valve system of the present invention performs a heart valve operation by implanting the support member first in the manner of implanting the heart valve body, the stability of the valve body is higher in the operation process of the present invention, by separately implanting the valve and the support member, the stability of the valve body can be better considered in the design, the influence on the valve body in the deformation process is reduced, in some existing integrated valve support designs, the valve and the support are tightly combined together, in the implantation process, the support may need to undergo a certain degree of deformation to adapt to the space in the heart, the deformation may have a certain influence on the valve body, which leads to the valve function being damaged, and the valve body and the support member are separately implanted in the present invention, the stability of the valve body can be better considered in the design, the influence on the valve body in the deformation process is reduced, for example, the material and the structure of the valve body can be optimized, so as to improve the stability and tolerance of the valve body in the deformation process; furthermore, the support and the valve can be optimized independently in the present invention: the valve and the bracket are separately implanted, so that the characteristics of the valve and the bracket can be respectively optimized, the overall performance and effect are improved, for example, the bracket can be customized according to the heart structure and pathological conditions of a patient, and better supporting and fixing effects are provided; the valve can be optimized according to the hemodynamic requirements of a patient so as to improve the functional performance of the valve, and the independent optimization can enable the valve and the bracket to achieve better performance in respective functional aspects, so that the overall treatment effect is improved; in addition, there may be better personalized treatments: the valve and the stent are separately implanted, and the proper valve and the stent can be selected according to the specific situation of a patient so as to achieve the optimal treatment effect. For example, for some patients, a specially designed stent may be required to accommodate their cardiac structure, while other patients may require a valve with specific functions to meet their hemodynamic requirements. This split mounting approach allows for more flexibility in meeting the needs of different patients, providing a more personalized treatment regimen.
The present invention is not limited to the above-mentioned embodiments, and any person skilled in the art, based on the technical solution of the present invention and the inventive concept thereof, can be replaced or changed within the scope of the present invention.
It should be noted that in this document, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
Claims (10)
1. A split absorbable artificial intervention heart valve system, comprising:
a delivery conduit having a first receiving area disposed thereon, the first receiving area receiving a support;
a guide catheter arranged to connect the delivery catheter first end, the guide catheter having a second receiving area arranged thereon, the second receiving area configured to receive a heart valve body;
a power system for moving the support from the first receiving area into the external environment and the heart valve body from the second receiving area into the external environment;
the external environment is atrium and/or ventricle, the connecting part is arranged on the supporting piece, and the joint part is arranged on the heart valve body and the connecting part on the supporting piece in a matching way.
2. The split absorbable artificial intervention heart valve system of claim 1, wherein the material of the support member partial region is polylactic acid or polycaprolactone.
3. The split absorbable artificial intervention heart valve system of claim 1, wherein the support comprises a plurality of annular support members arranged along a first path, the first path being a path of a junction of an atrium and a ventricle where the support is placed;
wherein the support member includes peak areas and valley areas alternately arranged, the support member having a compressed state and an expanded state, an end face outer wall dimension of the support member being smaller than an inner wall dimension of the first receiving area when the support member is in the compressed state, and an end face inner wall dimension of the support member being larger than an outer wall dimension of the first receiving area when the support member is in the expanded state;
the area of the valley region in the expanded state is greater than the area of the valley region in the compressed state.
4. A split absorbable artificial intervention heart valve system as in claim 3, wherein said support further comprises a balloon, said support member being disposed about the periphery of said balloon;
the air bag comprises a first state and a second state, the volume of the air bag in the first state is larger than that of the air bag in the second state, and the air bag surrounds and restrains to radially support the supporting member in the expanded state or to deliver the supporting member in the compressed state.
5. The split absorbable artificial intervention heart valve system of claim 4, wherein the delivery catheter comprises a first light emitting region, the first receiving region disposed on one side of the first light emitting region;
the support member is made of memory metal, and when the first light emergent area acts on the support member, the support member is converted from an expanded state to a compressed state.
6. The split absorbable artificial intervention heart valve system of claim 5, wherein the first light emitting region comprises:
the two light guide pieces are semi-cylindrical; the two light guide pieces are spliced to form a cylinder;
the splicing surfaces of the two light guide pieces are covered on two sides of the light reflecting layer;
the light guide piece comprises a light guide piece, a light emitting unit and a light receiving unit, wherein the light guide piece is arranged on the light incident side of the light guide piece, and the curved side edge of the light guide piece forms a light emitting surface;
the light-emitting surface of the light guide piece is a supporting surface, and the air bag is supported through the light-emitting surface.
7. The split absorbable artificial intervention heart valve system of claim 6, wherein the light emitting surface of the light guide comprises a first end close to the illumination unit and a second end far from the illumination unit, and wherein the surface edge area of the light emitting surface close to the first end and/or the second end is provided with a protrusion;
the protrusion includes a reflection area whose reflection surface reflects incident light toward a center position of the support.
8. The split absorbable artificial intervention heart valve system of claim 7, wherein the reflective area of the boss is concavely disposed.
9. The split absorbable artificial intervention heart valve system of claim 8, wherein a light guide fiber is arranged inside the delivery catheter, a light supplementing region is arranged at the other side of the first light emitting region, and the light guide fiber extends into the light supplementing region;
part of the light rays of the light supplementing area act on the support member in an expanded state.
10. The split absorbable artificial intervention heart valve system of claim 9, wherein the light supplementing region comprises:
an enclosure that encloses the light guide fiber;
the notch is formed in the surface of the surrounding body;
the first medium fills the notch so as to enable the surrounding body to be in a sealing state;
wherein the refractive index of the first medium is greater than air.
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| CN202310793499.5A CN117017572A (en) | 2023-06-30 | 2023-06-30 | Split absorbable artificial intervention heart valve system |
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| CN202310793499.5A CN117017572A (en) | 2023-06-30 | 2023-06-30 | Split absorbable artificial intervention heart valve system |
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