CN114504413B - Implantable medical device and implantable medical device kit - Google Patents
Implantable medical device and implantable medical device kit Download PDFInfo
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- CN114504413B CN114504413B CN202210058239.9A CN202210058239A CN114504413B CN 114504413 B CN114504413 B CN 114504413B CN 202210058239 A CN202210058239 A CN 202210058239A CN 114504413 B CN114504413 B CN 114504413B
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- 238000007789 sealing Methods 0.000 claims description 37
- 239000012528 membrane Substances 0.000 claims description 17
- 230000017531 blood circulation Effects 0.000 abstract description 29
- 238000000034 method Methods 0.000 abstract description 19
- 239000010408 film Substances 0.000 description 30
- 238000002513 implantation Methods 0.000 description 17
- 230000003902 lesion Effects 0.000 description 12
- 238000001356 surgical procedure Methods 0.000 description 10
- 210000001765 aortic valve Anatomy 0.000 description 9
- 239000000463 material Substances 0.000 description 9
- 208000002251 Dissecting Aneurysm Diseases 0.000 description 8
- 210000003484 anatomy Anatomy 0.000 description 8
- 206010002895 aortic dissection Diseases 0.000 description 8
- 210000004351 coronary vessel Anatomy 0.000 description 7
- 208000001750 Endoleak Diseases 0.000 description 6
- 239000011248 coating agent Substances 0.000 description 6
- 238000000576 coating method Methods 0.000 description 6
- 239000013039 cover film Substances 0.000 description 6
- 210000000709 aorta Anatomy 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 5
- 230000006835 compression Effects 0.000 description 4
- 238000007906 compression Methods 0.000 description 4
- 206010064396 Stent-graft endoleak Diseases 0.000 description 3
- 210000002376 aorta thoracic Anatomy 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 238000004873 anchoring Methods 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 210000002254 renal artery Anatomy 0.000 description 2
- 238000009958 sewing Methods 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 206010002329 Aneurysm Diseases 0.000 description 1
- 200000000007 Arterial disease Diseases 0.000 description 1
- 229910000684 Cobalt-chrome Inorganic materials 0.000 description 1
- 206010018852 Haematoma Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
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- 238000009954 braiding Methods 0.000 description 1
- 239000010952 cobalt-chrome Substances 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 1
- 229920005570 flexible polymer Polymers 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
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- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 description 1
- 238000002161 passivation Methods 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (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 provides an implantable medical device and an implantable medical device kit, wherein the implantable medical device comprises a main body lumen structure, the main body lumen structure comprises a main body bracket and a covering film, the covering film is covered on the main body bracket to form a conveying channel with two open ends, at least one opening which can be opened and closed is formed on the covering film, the main body lumen structure is divided into a proximal end part and a distal end part by the opening, and when the proximal end part or the distal end part is radially compressed and the distal end part or the proximal end part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radial unfolding state, the opening is in a closing state; in the open state, the opening communicates with the delivery channel. The implantable medical device can keep blood flow smooth in the operation process, and can avoid or reduce internal leakage after the operation is finished.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an implantable medical instrument and an implantable medical instrument kit.
Background
This section provides merely background information related to the present disclosure and is not necessarily prior art.
Aortic dissection, also known as aortic dissection aneurysm, refers to hematoma formed by blood in the aortic lumen entering the middle layer of the aortic wall through a rupture of the intima, which is an arterial disease with high risk and has high mortality and complication rate.
Traditional methods of treating aortic dissection are generally surgical treatments, typically cutting the intimal tear, preventing major bleeding due to dissection and reestablishing blood flow paths through vascular prostheses.
At present, a membrane stent is implanted in a lesion part in a minimally invasive intervention mode so as to isolate blood flow and maintain a normal blood flow channel. Minimally invasive intervention has become a suitable conventional treatment means because of its definite therapeutic effect, small trauma, rapid recovery and few complications.
When a lesion site affects or is close to a branch vessel, for example, the lesion site affects or is close to a branch vessel at the aortic arch; as another example, the lesion is adjacent to a coronary vessel, etc. In order to cover the lesion or to add sufficient anchoring area, the stent graft may cover or block the openings of the branch vessel or coronary vessel, etc. In such cases, it is often necessary to implant a main body stent and a branch stent (or "bypass stent") that cooperate to maintain the blood flow of the aorta and branch vessels or coronary vessels, etc. clear. This adds difficulty to the implantation procedure. Generally, the implantation procedure is performed as follows: the main body stent is firstly conveyed to the corresponding position, then the main body stent is partially released, then the branch stent is conveyed to the corresponding position, then the branch stent is released, the branch stent is matched with the main body stent, and finally the main body stent is completely released, so that the operation is completed.
However, during the release of the branch stent, since the main body stent is located in the blood vessel in the semi-released state, it is not completely opened, which may obstruct the blood flow to some extent. When blood flow is blocked for too long, the health of the patient can be adversely affected, and life can be seriously and even endangered. In addition, for the situation that the main body bracket is matched with the branch bracket, the occurrence of internal leakage is avoided or reduced after the operation is completed.
Thus, during the surgical procedure, blood flow is maintained clear; and avoiding or reducing the occurrence of endoleaks after the surgery is completed.
Disclosure of Invention
In view of this, it is desirable to provide an implantable medical device that maintains blood flow during surgery and that avoids or reduces the occurrence of endoleaks after surgery is completed.
Further, an implantable medical device kit is provided that can maintain blood flow clear during surgery and can avoid or reduce the occurrence of endoleak after surgery is completed.
An implantable medical device, comprising: the main body lumen structure comprises a main body support and a covering film, wherein the covering film is covered on the main body support to form a conveying channel with two open ends, at least one opening which can be opened and closed is formed in the covering film, the opening divides the main body lumen structure into a proximal end part and a distal end part, and when the proximal end part or the distal end part is radially compressed and the distal end part or the proximal end part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radial unfolding state, the opening is in a closing state; in the open state, the opening communicates with the delivery channel.
In one embodiment, the implantable medical device further comprises a seal disposed inside the body lumen structure and surrounding the body lumen structure longitudinal central axis, the seal configured to seal the opening such that the opening is in a closed state.
In one embodiment, the radial support force of the seal is less than the radial support force of the body mount.
In one embodiment, the seal comprises a seal holder and a seal membrane coupled to the seal holder, a projection of the seal membrane onto an inner wall of the body lumen structure covering the opening.
In one embodiment, the implantable medical device further comprises an abutment disposed outside of the body lumen structure; when the proximal or distal portion is radially compressed and the distal or proximal portion is not compressed, the abutment abuts the cover to open the opening.
In one embodiment, the abutment comprises a band surrounding the body lumen structure, the band being located at a proximal or distal end of the opening, and a projection of the band onto the body lumen structure does not overlap the opening.
In one embodiment, the wave ring includes a plurality of supporting portions and a plurality of connecting portions, the supporting portions and the connecting portions are alternately connected to form the wave ring, and an axial distance between the supporting portions and the opening is smaller than an axial distance between the connecting portions and the opening.
In one embodiment, the radial support force of the wave ring is smaller than the radial support force of the body support.
In one embodiment, the supporting member includes a plurality of supporting rods, the plurality of supporting rods are disposed outside the main body lumen structure, one end of each supporting rod is connected with the main body lumen structure, the other end extends towards a direction close to the opening, and one end of each supporting rod close to the opening is located at a proximal end or a distal end of the opening.
In one embodiment, the opening is arcuate, in-line, S-shaped, zig-zag, cross-shaped, or semi-cross-shaped.
In one embodiment, the main body support comprises a first support and a second support connected with the first support, the diameter of one end of the second support connected with the first support is larger than that of one end of the second support far away from the first support, the first support and the second support are covered by the covering film, and the opening is positioned at the second support.
In one embodiment, the implantable medical device further comprises a valve structure coupled to the body support; alternatively, the implantable medical device further comprises a valve structure for use with the body support.
An implantable medical device kit, comprising:
at least one bypass cradle; and
an implantable medical device as in any one of the embodiments above, one end of each of the bypass stents may extend into the opening.
The implementation of the embodiment of the disclosure has the following beneficial effects:
in implantation procedures, the proximal or distal portion of the body lumen structure is released first, maintaining the distal or proximal portion in a radially compressed state, leaving the opening open to communicate with the delivery channel, such that blood flow can flow along the delivery channel through the opening or into the delivery channel from the opening, thereby maintaining blood flow unobstructed during the procedure. After the operation is finished, the main body lumen structure is in a radial unfolding state, so that the opening is in a closing state, and the opening is disconnected with the communication of the conveying channel, namely the side surface of the conveying channel is closed, thereby avoiding or reducing the occurrence of internal leakage.
In the implantable medical device kit of the present disclosure, the implantable medical device of any of the above embodiments is used in combination with a bypass stent, one end of which may extend into an opening of the implantable medical device, and the other end of which is implanted in the bypass anatomy or branch anatomy. Alternatively, the implantable medical device of any of the embodiments described above may be used with a bypass stent using a chimney stent technique. Whether one end of the bypass bracket extends into the opening or not, the implantable medical device of any embodiment is provided with the opening which can be opened and closed, and the opening mode is associated with the implantation, so that blood flow can be kept smooth in the implantation implementation process, and after the operation is finished, the opening is in a closed state, the side face of the conveying channel is closed, and the occurrence of internal leakage is avoided or reduced.
Drawings
In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings may be obtained according to these drawings without inventive effort to a person of ordinary skill in the art.
Wherein:
FIG. 1 is a schematic structural view of an implantable medical device kit according to one embodiment;
FIG. 2 is a schematic structural view of an implantable medical device according to an embodiment;
FIG. 3 is a schematic perspective view of an implantable medical device according to one embodiment;
FIG. 4 is a schematic diagram of a first waveform ring according to an embodiment;
FIG. 5 is a top view of an implantable medical device according to one embodiment;
FIG. 6 is a schematic view of the structure of an implantable medical device according to another embodiment;
FIG. 7 is an enlarged view of a portion of FIG. 2;
FIG. 8 is a schematic structural view of a seal of an embodiment;
FIG. 9 is a schematic view of the seal holder of the seal of an embodiment;
FIG. 10 is a partial schematic structural view of an implantable medical device according to an embodiment;
FIG. 11 is a schematic structural view of another embodiment implantable medical device;
fig. 12 is a schematic view of a state of an implantation process of an implantable medical device according to an embodiment.
Detailed Description
For the purposes of making the objects, technical solutions and advantages of the present disclosure more apparent, the technical solutions in the present disclosure will be clearly and completely described below with reference to the accompanying drawings in which it is apparent that the described embodiments are some, but not all, embodiments of the present disclosure. All other embodiments, which can be made by one of ordinary skill in the art without inventive effort, based on the embodiments in this disclosure are intended to be within the scope of this disclosure.
In the field of interventional medical devices, the end located close to the heart is defined as the proximal end and the end remote from the heart is defined as the distal end. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.
Referring to fig. 1, an embodiment of the present invention provides an implantable medical device kit 1 including an implantable medical device 10 and a bypass cradle 20. The implantable medical device 10 is for implantation in a body lumen anatomy, such as an aorta. The bypass stent 20 is used for implantation in a branched vessel lumen anatomy, such as a branched vessel.
Referring to fig. 2, the implantable medical device 10 includes a body lumen structure 100, the body lumen structure 100 including a body stent 110 and a cover 120. The main body support 110 has a lumen structure, and the covering film 120 is coated on the main body support 110 to form a conveying channel 100a (as shown in fig. 3) with two open ends. The two open ends of the delivery channel 100a are axially opposite.
The covering film 120 is provided with at least one opening 122, and the opening 122 can be opened and closed. When the opening 122 is in an open state, the opening 122 communicates with the delivery channel 100a such that blood flow may flow out of the opening 122 or into the delivery channel 100a from the opening 122 when one open end of the delivery channel 100a is not open, i.e., blood flow may flow out or into the implantable medical device 10 from the side, even if one open end of the body lumen structure 100 is blocked, the blood flow may remain unobstructed. When the opening 122 is closed, blood flow cannot flow out of the side of the implantable medical device 10.
When it is not necessary to pass the bypass stent 20 through the openings 122, the number of openings 122 is at least one. When it is desired to pass the bypass stent 20 through the openings 122, the number of openings 122 is at least 1 greater than the number of bypass stents 20 to ensure blood flow through the openings 122.
In one embodiment, the plurality of openings 122 is provided, and the plurality of openings 122 are spaced apart along the circumference of the covering film 120. In the axial direction, the opening 122 divides the body lumen structure 100 into a proximal portion 100b and a distal portion 100c. Proximal portion 100b is located proximal of opening 122 and distal portion 100c is located distal of opening 122.
When the proximal portion 100b is radially compressed and the distal portion 100c is not radially compressed (i.e., in a radially expanded state), the opening 122 is in an open state. Alternatively, when the proximal portion 100b is radially expanded and the distal portion 100c is radially compressed, the opening 122 is in an open state. The opening 122 is in a closed state when both the proximal portion 100b and the distal portion 100c are radially deployed. When the opening 122 is in a closed position, the sides of the implantable medical device 10 are in a closed position, and the delivery channel 100a has only two axially opposite open ends, with blood flowing in the delivery channel 100a from one open end to the other.
In implantation procedures, either the proximal portion 100b or the distal portion 100c is released first, leaving the distal portion 100c or the proximal portion 100b in a radially compressed state (e.g., the proximal portion 100b or the distal portion 100c is pushed out of the delivery sheath while the distal portion 100c or the proximal portion 110b is not yet released from the delivery sheath and remains radially constrained by the delivery sheath in a radially compressed state; or the distal portion 100c or the proximal portion 100b is pushed out of the delivery sheath but is radially constrained by a constraining member, e.g., a tether, in a radially compressed state), the opening 122 is in an open state and is in communication with the delivery channel 100a such that blood flow along the delivery channel 100a can flow through the opening 122 or into the delivery channel 100a from the opening 122, thereby maintaining blood flow free during the procedure. After the operation is completed, the main body lumen structure 100 is in a radially expanded state, so that the opening 122 is in a closed state, and the opening 122 is disconnected from the delivery channel 100a, i.e., the side surface of the delivery channel 100a is closed, thereby avoiding or reducing the occurrence of endoleak.
During the implantation procedure, opening of the opening 122 can be accomplished to clear blood flow, either by first releasing the proximal portion 100b or by first releasing the distal portion 100 c. And, after the operation is completed, the opening 122 is closed. Thus, the implantable medical device 10 can be adapted for different implantation paths to facilitate selection of an appropriate implantation path according to the patient's actual condition. For example, when the implanted medical device set 1 is used to treat aortic lesions involving coronary arteries, a transapical implantation method, a transfemoral implantation method, or the like may be employed.
With continued reference to fig. 2, the main body support 110 includes a plurality of first wavy annular objects 111 arranged along an axial direction, and the coating film 120 is coated on the plurality of first wavy annular objects 111 to form a conveying channel 100a with two open ends.
In one embodiment, adjacent first wavy loops 111 are connected to each other. As shown in fig. 2, the first wavy annular object 111 and another first wavy annular object 111 adjacent thereto are connected in such a manner that the peaks and the valleys are mutually hung. In one embodiment, the plurality of first undulating rings 111 are connected by an axially extending connecting rod (not shown) such that the main body stent 110 is directional and readily bendable on the side opposite the connecting rod to accommodate the bent luminal anatomy. Alternatively, the plurality of first wavy rings 111 are connected by a plurality of connecting rods, each connecting rod connects two adjacent first wavy rings 111, and the plurality of connecting rods form a straight line in the axial direction, so that the main body support 110 has directivity, and is easy to bend on the opposite side of the connecting rod so as to adapt to the bent lumen anatomy structure. Alternatively, the plurality of first wavy rings 111 are connected by a plurality of connecting rods, each connecting rod connecting two adjacent first wavy rings 111, the adjacent connecting rods being axially offset, in such a way that the body stent 110 is more compliant and is easily passed through the curved luminal anatomy to reach the target site.
In one embodiment, the body support 110 may be formed by braiding a resilient wire, such as a nitinol wire or cobalt chrome wire. In another embodiment, the body support 110 may be formed by cutting and shaping a resilient metal tube, such as a nickel-titanium alloy tube or a cobalt-chromium alloy tube.
The placement of the opening 122 is appropriately set according to the actual situation, so that when the opening 122 is required to be mated with the bypass stent 20 after implantation, the position of the opening 122 is adapted to the end of the bypass stent 20 remote from the opening 122 to extend into the branch vessel, and the proximal portion 100b and the distal portion 100c can cover the lesion and have a sufficient anchoring length.
With continued reference to fig. 2, in one embodiment, the body support 110 further includes a second undulating ring 112. The first wavy annular body 111 and the second wavy annular body 112 are sequentially arranged in the axial direction. In an embodiment, the second wavy annular object 112 is connected to the adjacent first wavy annular object 111 in a mode of hooking peaks and valleys, and the coating film 120 is coated on the first wavy annular object 111 and the second wavy annular object 112 at the same time to form a conveying channel 100a with two open ends.
The number of the second wavy rings 112 may be one or more. When the number of the second wavy rings 112 is plural, the connection mode between the plurality of second wavy rings 112 may be a mode that the peaks and the troughs are hooked and connected with each other, or may be a mode that one connecting rod is adopted for connection or a mode that a plurality of connecting rods are adopted for connection.
The first waveform ring 111 includes a plurality of first waveforms 1111 (as shown in fig. 4), and the plurality of first waveforms 1111 are connected end to form the first waveform ring 111. The second waveform ring 112 includes a plurality of second waveforms 1121, and the plurality of second waveforms 1121 are connected end-to-end to form the second waveform ring 112. The number of first waveforms 1111 is greater than the number of second waveforms 1121, and the width L of the first waveforms 1111 is smaller than the width of the second waveforms 1121. A gap is formed between any adjacent two of the second waveforms 1121, and the opening 122 is located in the gap between the adjacent two of the second waveforms 1121. A second wavy annulus 112 comprising a second wavy shape 1121 of greater width is provided to allow for a larger size opening 122 to be provided to facilitate maintaining blood flow unobstructed during surgery. In addition, the first wavy annular objects 111 including a large number of first wavy annular objects 1111 have better radial support performance of the main body support 110 under the advance of the equal wire diameters of the first wavy annular objects 111 and the second wavy annular objects 112.
In one embodiment, the implantable medical device 10 further comprises a valve structure 200, wherein the valve structure 200 comprises a valve support 210 and a covering film 220 covering the valve support 210, and the covering film 220 is covered on the valve support 210 to form a lumen structure with two open ends, and the lumen structure is communicated with the conveying channel 100 a. Referring to fig. 5, the valve structure 200 further includes three leaflets 230. When the implantable medical device 10 is implanted in the body, the three leaflets 230 close and open as the heart expands and contracts, thereby closing or opening the delivery channel 100 a. The material of the leaflet 230 can be a biomaterial or a polymeric material. It should be noted that, in other embodiments, the leaflet 230 is not limited to three, for example, two or four.
Returning to fig. 2, the valve holder 210 includes a plurality of axially aligned third undulating rings 211. In one embodiment, the plurality of third wavy loops 211 are connected by hooking at the peaks and valleys. In one embodiment, the third undulating ring 211 and the second undulating ring 112 are connected by a connector 114 such that the valve holder 210 is connected to the main body holder 110. The connection member 114 winds around the peaks and valleys to connect the third wavy annulus 211 and the second wavy annulus 112. The connector 114 may be a flexible connection or a rigid connection. In an embodiment, the flexible connection element may be a flexible wire, for example, a flexible polymer wire, to connect the third wavy ring 211 and the second wavy ring 112. The rigid connection may be, for example, a wire or the like.
In another embodiment, the valve structure 200 and the body lumen structure 100 may be connected by suturing. For example, the covering film 220 of the valve structure 200 is inserted into the lumen of the main body lumen structure 100, or the covering film 220 of the valve structure 200 is sleeved on the main body lumen structure 100 and is sutured with a suture to connect the valve structure 200 and the main body lumen structure 100.
It should be noted that, in other embodiments, the valve structure 200 is used in cooperation with the main body lumen structure 100, and before use, the valve structure 200 with a suitable specification is selected according to the actual situation of the patient, and then the valve structure 200 is connected with the main body lumen structure 100.
In one embodiment, the diameters of the first wavy annulus 111, the second wavy annulus 112 and the third wavy annulus 211 are equal.
The materials of the cover 120 and the cover 220 are flexible materials capable of blocking blood flow and suitable for implantation into the human body, including, but not limited to, expanded polytetrafluoroethylene, polyurethane, silicone, and the like.
The materials of the cover film 120 and the cover film 220 may be non-absorbable materials and absorbable materials.
Referring to fig. 6, another embodiment of an implantable medical device 10 is shown having a slightly different body 110 than the embodiment shown in fig. 2. The main body bracket 110 includes a first bracket 110a and a second bracket 110b connected to the first bracket 110 a. The diameter of the end of the second bracket 110b connected to the first bracket 110a is larger than the diameter of the end of the second bracket 110b remote from the first bracket 110 a. In one embodiment, the first support 110a is hollow cylindrical, the second support 110b is hollow truncated cone, and the larger diameter end of the second support 110b is connected to the first support 110a, so that the implantable medical device 10 can be adapted for non-uniform diameter luminal anatomy. For example, when the aortic lesion is close to the aortic valve, the implantable medical device 10 extends from the aortic valve to the ascending aorta, and the implantable medical device 10 is suitable for a case where the diameter of the ascending aorta is larger than that of the aortic valve annulus.
In an embodiment, the first bracket 110a includes a plurality of first wavy annular structures 115 axially arranged, and the connection manner of the plurality of first wavy annular structures 115 is the same as that of the plurality of first wavy annular objects 111 in the above-described embodiment, which is not repeated herein.
The second bracket 110b includes at least one second wavy annular structure 116. When the second bracket 110b includes a second wavy annular structure 116, the second wavy annular structure 116 is connected with the adjacent first wavy annular structure 115 by hooking the peaks and the valleys. When the second bracket 110b includes a plurality of second wavy annular structures 116, the second wavy annular structure 116 closest to the first bracket 110a is hooked adjacent to the adjacent first wavy annular structure 115 by the peaks and valleys. Adjacent second wavy annular structures 116 may also be connected by hooking peaks and valleys.
Alternatively, in an embodiment, the first bracket 110a and the second bracket 110b are integrally formed by integrally cutting and shaping.
In this embodiment, the cover 120 is coated on the first bracket 110a and the second bracket 110b to form a conveying channel 100a with two open ends. The opening 122 is located at the second bracket 110b.
The first wavy annular structure 115 includes a plurality of first waves 1151, and the plurality of first waves 1151 are connected end to form the first wavy annular structure 115. The second wave ring structure 116 includes a plurality of second waves 1161, and the plurality of second waves 1161 are connected end to form the second wave ring structure 116. The number of first waveforms 1151 is greater than the number of second waveforms 1161, and the width of the first waveforms 1151 is smaller than the width of the second waveforms 1161. The openings 122 are located between adjacent second waveforms 1161. The provision of the larger width second waveforms 1161 to provide larger sized openings 122 between adjacent second waveforms 1161 facilitates maintaining blood flow unobstructed during surgery.
With continued reference to fig. 6, in this embodiment, the implantable medical device 10 further includes a valve structure 300. The valve structure 300 is identical to the valve structure 200 and will not be described in detail here. When aortic dissection patients simultaneously develop aortic valve lesions requiring replacement of the native aortic valve, aortic dissection and replacement of the native aortic valve can be simultaneously treated using the above-described implantable medical device 10. With the implantable medical device kit 1, the implantable medical device 20 is matched with the bypass stent 20, the bypass stent 20 is implanted into the coronary blood vessel, and the coronary blood vessel ischemia caused by the blocking of the coronary blood vessel orifice by the covering film 120 is avoided.
Returning to fig. 1, in one embodiment, the openings 122 are multiple and the multiple openings 122 are distributed across two axially spaced sections, dividing the body lumen structure 100 into a proximal portion 100-1, a distal portion 100-2 and a middle portion 100-3 between the proximal portion 100-1 and the distal portion 100-2, the proximal portion 100-1 being connectable with either the valve structure 200 or the valve structure 300. When aortic valve lesions are simultaneously occurring in an aortic dissection patient and aortic dissection affects the aortic arch, with the implantable medical device kit 1 of this embodiment, aortic dissection and replacement of the native aortic valve can be simultaneously treated without occluding the branch vessels of the aortic arch and the coronary vessels of the aortic valve.
It should be noted that the number of bypass holders 20 is not limited and may be selected as needed.
The application site of the implantable medical device set 1 is not limited to the aorta, and may be applied to other sites having branched blood vessels, for example, renal arteries. It will be appreciated that valve structure 200 or valve structure 300 is omitted when applied to renal arteries and the like other locations where replacement of the native valve is not required.
It should be further noted that, in the implantable medical device kit 1 shown in fig. 1, the bypass cradle 20 is mated with the implantable medical device 10 in such a manner that one end of the bypass cradle 20 protrudes into the opening 122. In other embodiments, the implantable medical device 10 and bypass cradle 20 may be mated in a chimney technique.
Returning to FIG. 2, in one embodiment, the opening 122 is arcuate. It should be noted that, in other embodiments, the shape of the opening 122 is not limited to an arc shape, and may be, for example, a straight line, an S-shape, a zigzag shape, a cross shape, a semi-cross shape, or the like.
Referring to fig. 7, in one embodiment, the opening 122 includes a first edge 1221 and a second edge 1222, and when one end of the body lumen structure 100 is compressed, the distance between the first edge 1221 and the second edge 1222 increases, causing the opening 122 to be in an open state.
It is understood that when the opening 122 is in a straight shape, the first edge 1221 and the second edge 1222 are both straight. When the opening 122 is S-shaped, both the first edge 1221 and the second edge 1222 are S-shaped. Also, when the opening 122 is saw-tooth in shape, both the first edge 1221 and the second edge 1222 are saw-tooth. When the opening 122 is cross-shaped or semi-cross-shaped in shape, the opening 122 includes a plurality of edges.
Referring back to fig. 3, in one embodiment, the implantable medical device 10 further includes a seal 130, the seal 130 being disposed inside the body lumen structure 100, and the seal 130 surrounding a longitudinal central axis of the body lumen structure 100. The seal 130 is used to cover or conceal the opening 122 when the body lumen structure 100 is in a radially expanded state.
Referring to fig. 8, in one embodiment, the sealing member 130 includes a sealing bracket 131 and a sealing membrane 132 connected to the sealing bracket 131. Referring to fig. 9, the sealing bracket 131 has a wave-shaped ring structure, and may have a sine wave structure, a Z-wave structure, or the like. The sealing film 132 is fixed to the sealing bracket 131. In one embodiment, the sealing bracket 131 is located on the side of the sealing membrane 132 facing the lumen of the body lumen structure 100. In another embodiment, the sealing membrane 132 includes an outer membrane and an inner membrane, and the sealing bracket 131 is positioned between the outer membrane and the inner membrane.
The edge of one end of the sealing film 132 is rounded and the shape of the edge of the other end matches the shape of the sealing bracket 131. Also, both the proximal and distal edges of the sealing membrane 132 extend beyond the sealing bracket 131 so that the sealing membrane 132 can cover the opening 122.
In one embodiment, the seal 130 is secured to the inner wall of the body lumen structure 100 by stitching. For example, the suture points are located at the peaks and valleys of the sealing bracket 131. In another embodiment, the seal 130 is affixed to the inner wall of the body lumen structure 100 by means of adhesive.
It should be noted that, no matter how the sealing member 130 is fixed to the inner wall of the main body lumen structure 100, the projection of the sealing film 132 on the inner wall of the main body lumen structure 100 covers the opening 122, as shown in fig. 10. Also, the projection of the portion of the seal 130 fixedly connected to the body lumen structure 100 onto the inner wall of the body lumen structure 100 does not cover the opening 122 to avoid difficulty in opening the opening 122. Meanwhile, the projection of the sealing bracket 131 on the inner wall of the main body lumen structure 100 is positioned at the proximal end or the distal end of the opening 122, so that the interference of the sealing bracket 131 on the opening 122 is avoided. The arrangement is such that the opening 122 can be in an open state when one end of the body lumen structure 100 is radially compressed and the other end is not radially compressed. And the sealing bracket 131 is woven by elastic wires, and the sealing membrane 132 is abutted against the inner wall of the main body lumen structure 100 by the radial supporting force of the sealing bracket 131, so that the sealing membrane 132 can cover the opening 122 in the radial expansion state to avoid internal leakage.
In one embodiment, the radial support force of the seal holder 131 is smaller than the radial support force of the body holder 110. The implantable medical device 10 is anchored to the lesion by means of the radial supporting force of the main body stent 110, and thus the radial supporting force of the main body stent 110 needs to be large. The radial supporting force of the seal holder 131 is large enough to enable the seal film 132 to cover the opening 122 without being excessively large. Thus, the seal holder 131 may be made of a thinner wire to reduce the radial dimension of the implantable medical device 10 after compression.
The seal 130 is an annular structure including a seal holder 131 and a sealing membrane 132 such that one seal 130 can cover all of the openings 122 when the plurality of openings 122 are spaced circumferentially along the body lumen structure 100.
In other embodiments, the sealing bracket 131 is not limited to a sine wave structure or a wave structure such as a zigzag wave, and may be configured to be capable of abutting the sealing film 132 in a radially expanded state so that the sealing film 132 can cover the opening 122. For example, in one embodiment, the seal holder 131 is a ring-shaped structure. However, providing the sealing bracket 131 with a wave-like structure such as a sine wave or a Z-wave is advantageous for compressing the sealing bracket 131 for transportation.
Referring back to fig. 6, in an embodiment, the implantable medical device 10 further includes a holding member 140, where the holding member 140 is disposed outside the main body support 110, and when an end of the main body lumen structure 100 where the holding member 140 is located is radially compressed, the holding member 140 holds the covering film 120, so that a distance between the first edge 1221 and the second edge 1222 of the opening 122 is increased, and the opening 122 is in an open state. The holding member 140 is provided outside the main body bracket 110, and may be covered with the coating film 120 or may be sleeved on the coating film 120. The abutment 140 can be fixedly attached to the body lumen structure 100 by stitching, adhesive, or the like.
In one embodiment, the abutment 140 comprises an annular wave ring. The supporting member 140 is sleeved outside the main body bracket 110. The wave ring comprises a plurality of propping parts and a plurality of connecting parts, and the plurality of propping parts and the plurality of connecting parts are alternately adjacent to form an annular wave ring. The abutting portion is used for abutting the covering film 120 to open the opening 122. With continued reference to fig. 6, the abutment 140 includes a plurality of high waveforms 141 and a plurality of low waveforms 142, and the plurality of high waveforms 141 and the plurality of low waveforms 142 are alternately connected to form a closed annular ring. The high waveform 141 serves as a contact portion, and the low waveform 142 serves as a connection portion. The wave height of the high waveform 141 is greater than the wave height of the low waveform 142. At the portion where the opening 122 is formed, the high waveform 141 extends axially to be close to the opening 122, so that the axial distance between the end of the abutting portion close to the opening 122 and the opening 122 is smaller than the axial distance between the end of the connecting portion close to the opening 122 and the opening 122. When one end of the body lumen structure 100 is radially compressed such that the abutment 140 is in a radially compressed state or one end of the abutment 140 distal from the opening 122 is in a radially compressed state, the high waveform 141 abuts the cover film 120 such that the opening 122 is open.
It should be noted that, in other embodiments, the abutment 140 includes a plurality of equal-height waveforms, and the plurality of equal-height waveforms are connected end to form a closed annular wave ring. However, since the plurality of openings 122 are spaced apart in the circumferential direction of the body lumen structure 100, a high waveform 141 and a low waveform 142 are provided, and the openings 122 are driven to open by the high waveform 141, the low waveform 142 serves as a connection. On the one hand, the high waveform 141 and the low waveform 142 are connected, so that when the abutting piece 140 is subjected to radial compression, the high waveform 141 can better abut against the covering film 120 to promote the opening 122 to be opened; on the other hand, the lower wave height of the low wave form 142 is beneficial for reducing the amount of wire used and reducing the local radial dimension of the implantable medical device 10 after radial compression.
In one embodiment, the radial support force of the pulsator is smaller than the radial support force of the main body support 110. When in a radially compressed state, the high waveform 141 of the band can abut against the covering film 120 to open the opening 122, and the band with a large radial supporting force is not required. Accordingly, the wave ring may be made of a thinner wire to reduce the radial dimension of the implantable medical device 10 after compression.
It should be noted that, in other embodiments, the low-wave 142 may be omitted, the supporting member 140 includes a plurality of discrete high-wave 141, and when the plurality of discrete high-wave 141 is radially compressed, the closed end of the high-wave 141 can also support the covering film 120, so as to open the opening 122. The closed end of the high waveform 141 is a closed structure, and has no sharp end, and the coating 120 is not pierced. Further, the two free ends of the high waveform 141 are passivated to avoid puncturing the coating.
Referring to fig. 11, in one embodiment, the supporting member 140 has another structure. The supporting member 140 includes a plurality of discrete supporting rods 143, one end of each supporting rod 143 is connected to the second wavy annular structure 116, and the other end extends axially to be close to the opening 122, when the supporting rods 143 are radially bound in the sheath or partially bound in the sheath, and the other end of the main body lumen structure 100 located in the opening 122 is in a radially expanded state, the supporting rods 143 support the covering film 122, so that the opening 122 is opened.
In one embodiment, the abutment 140 further includes a connecting portion 144, and the connecting portion 144 is connected to an end of the abutment rod 143 away from the opening 122. In one embodiment, the connecting portion 144 is a ring structure, and the connecting portion 144 is hooked on the second wavy ring structure 116. The connecting portion 144 and the holding rod 143 are further connected to the cover film 120 by sewing.
In other embodiments, the connecting portion 144 may be omitted, and the diameter of one end of the supporting rod 143 may be connected to the second wavy annular structure 116, for example, by welding. Then, the end of the holding rod 143 near the opening 122 is connected to the cover film 120 by sewing.
In one embodiment, the abutment 140 further comprises a blunting portion 145, the blunting portion 145 being connected to an end of the abutment rod 143 near the opening 122. The passivation 145 has a rounded surface to avoid the abutment rod 143 from puncturing the cover film 120.
Referring to fig. 12, an implantable medical device 10 is loaded onto a delivery sheath 30. In operation, the implantable medical device 10 is delivered to the lesion through the delivery sheath 30. The distal portion 100c of the body lumen structure 100 is then released, and as shown in fig. 12, the proximal portion 100b is at least partially radially compressed by the delivery sheath 30, with the opening 122 in an open state. The bypass stent 20 (not shown in fig. 12) is delivered to the corresponding location and one end of the bypass stent 20 is passed through one of the openings 122 and the other end is implanted in a branch vessel or coronary vessel. Alternatively, the bypass stent 20 is implanted into a branch vessel or coronary vessel using a chimney technique. Then, the proximal portion 100b of the body lumen structure 100 is released, causing the proximal portion 100b to assume a radially expanded state, closing the opening 122. If the implantable medical device 10 further comprises a valve structure 200 or 300, the valve structure 200 or 300 is continued. Finally, the delivery sheath 30 is withdrawn, completing the procedure.
During implantation of the bypass stent 20, at least one opening 122 is left open to allow blood flow from the opening 122 into the delivery channel 100 a. Or from the delivery channel 100a through the opening 122. Thus, during surgery, the presence of the opening 122 can provide for unobstructed blood flow even if at least a portion of the proximal portion 100b is radially compressed or radially constrained by the delivery sheath 30 to temporarily block one open end of the delivery channel 100a during the procedure, as a result of the need to implant the bypass stent 20. And, when the body lumen structure 100 is completely released, the opening 122 is in a closed state, avoiding endoleak.
By providing the seal 130, the seal 130 is able to seal the opening 122 in a radially expanded state of the body lumen structure 100, which is advantageous in avoiding endoleaks. By providing the holding member 140, the opening 122 is opened or the opening 122 is opened to a larger extent by holding the covering film 120, which is beneficial to ensuring smooth blood flow in the operation process. Opening of the opening 122 is promoted through the abutting piece 140, tightness is further improved through the sealing piece 130, and the opening 122, the sealing piece 130 and the abutting piece 140 are matched, so that smooth blood flow can be guaranteed, internal leakage is avoided, and safety and success rate of operation are improved.
It should be noted that, in other embodiments, the abutting element 140 may be omitted, and when the abutting element 140 is omitted, the opening 122 may be opened when one end of the main body lumen structure 100 is radially compressed and the other end is not radially compressed. However, the provision of the abutment 140 facilitates abutment of the covering film 120, resulting in a greater distance between the first edge 1221 and the second edge 1222 of the opening 122, even though the opening 122 is more open, resulting in a more unobstructed blood flow.
In the description of the embodiments of the present disclosure, it should be noted that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate an azimuth or a positional relationship based on that shown in the drawings, merely for convenience of describing the embodiments of the present disclosure and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific azimuth, be configured and operated in a specific azimuth, and thus should not be construed as limiting the embodiments of the present disclosure. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In describing embodiments of the present disclosure, it should be noted that, unless explicitly stated and limited otherwise, the terms "coupled," "coupled," and "connected" should be construed broadly, and may be either a fixed connection, a removable connection, or an integral connection, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in embodiments of the present invention will be understood in detail by those of ordinary skill in the art.
In the presently disclosed embodiments, unless expressly stated and limited otherwise, a first feature "up" or "down" on a second feature may be that the first and second features are in direct contact, or that the first and second features are in indirect contact via an intermediary. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the embodiments of the present disclosure. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, the different embodiments or examples described in this specification and the features of the different embodiments or examples may be combined and combined by those skilled in the art without contradiction.
Finally, it should be noted that: the above embodiments are merely for illustrating the technical solution of the present disclosure, and are not limiting thereof; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present disclosure.
Claims (12)
1. An implantable medical device, comprising: the main body lumen structure comprises a main body support and a covering film, wherein the covering film is covered on the main body support to form a conveying channel with two open ends, at least one opening which can be opened and closed is formed in the covering film, the opening divides the main body lumen structure into a proximal end part and a distal end part, and when the proximal end part or the distal end part is radially compressed and the distal end part or the proximal end part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radial unfolding state, the opening is in a closing state; in an open state, the opening is communicated with the conveying channel;
the implantable medical device further comprises a sealing element, wherein the sealing element is arranged inside the main body lumen structure and surrounds the longitudinal central axis of the main body lumen structure, and the sealing element is used for sealing the opening to enable the opening to be in a closed state.
2. The implantable medical device according to claim 1, wherein a radial support force of the seal is less than a radial support force of the body mount.
3. The implantable medical device according to claim 1, wherein the seal comprises a seal holder and a seal membrane coupled to the seal holder, a projection of the seal membrane onto an inner wall of the body lumen structure covering the opening.
4. The implantable medical device according to claim 1, further comprising an abutment disposed outside of the body lumen structure; when the proximal or distal portion is radially compressed and the distal or proximal portion is not compressed, the abutment abuts the cover to open the opening.
5. The implantable medical device of claim 4, wherein the abutment comprises a collar surrounding the body lumen structure, the collar being located proximal or distal to the opening, and a projection of the collar onto the body lumen structure does not overlap the opening.
6. The implantable medical device according to claim 5, wherein the collar comprises a plurality of abutments and a plurality of connections, the plurality of abutments and the plurality of connections being alternately connected to form the collar, the axial distance of the abutments from the opening being less than the axial distance of the connections from the opening.
7. The implantable medical device according to claim 5, wherein a radial support force of the pulsator is smaller than a radial support force of the main body stent.
8. The implantable medical device according to claim 4, wherein the holding member includes a plurality of holding rods disposed outside the main body lumen structure, one end of each holding rod is connected to the main body lumen structure, the other end extends in a direction approaching the opening, and one end of the holding rod approaching the opening is located at a proximal end or a distal end of the opening.
9. The implantable medical device according to claim 1, wherein said opening is arcuate, rectilinear, S-shaped, zigzag, cross-shaped or semi-cross-shaped.
10. The implantable medical device according to claim 1, wherein the main body stent comprises a first stent and a second stent connected to the first stent, a diameter of an end of the second stent connected to the first stent is larger than a diameter of an end of the second stent far away from the first stent, the covering film is coated on the first stent and the second stent, and the opening is positioned at the second stent.
11. The implantable medical device according to any one of claims 1-10, further comprising a valve structure coupled to the body support; alternatively, the implantable medical device further comprises a valve structure for use with the body support.
12. An implantable medical device kit, comprising:
at least one bypass cradle; and
the implantable medical device of any one of claims 1-10, wherein one end of each of the bypass stents is extendable into the opening.
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| CN202210058239.9A CN114504413B (en) | 2022-01-19 | 2022-01-19 | Implantable medical device and implantable medical device kit |
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| CN202210058239.9A CN114504413B (en) | 2022-01-19 | 2022-01-19 | Implantable medical device and implantable medical device kit |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111467099A (en) * | 2020-04-16 | 2020-07-31 | 四川大学华西医院 | Intravascular multilayer bare stent system |
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