CN115006053B

CN115006053B - Integrated intraoperative stent

Info

Publication number: CN115006053B
Application number: CN202210947004.5A
Authority: CN
Inventors: 董永贺; 刘颖; 朱明哲; 陈聪; 杜庆庆; 李广师; 罗静云
Original assignee: Beijing Huamai Taike Medical Instrument Co ltd
Current assignee: Beijing Huamai Taike Medical Instrument Co ltd
Priority date: 2022-08-09
Filing date: 2022-08-09
Publication date: 2022-11-15
Anticipated expiration: 2042-08-09
Also published as: CN115006053A

Abstract

The invention relates to the technical field of medical instruments, in particular to an integrated intraoperative stent. The integral intraoperative stent comprises: artificial blood vessels, tectorial membranes and supporting frameworks; the artificial blood vessel comprises a main pipe section, the near end of the covering membrane is continuously or discontinuously connected with the peripheral surface of the main pipe section close to the far end along the circumferential direction of the main pipe section, the supporting framework is positioned at the inner side of the covering membrane, and the far end side of the supporting framework is connected with the far end side of the covering membrane; be equipped with on the lateral wall of being responsible for the section with be responsible for the transport mouth of section inner chamber intercommunication, the transport mouth is used for pulling out the inner chamber that supports the skeleton from being responsible for the section outside to being responsible for to and, supply stretch out and support the skeleton that is in the compression state outside the transport mouth and get into and be responsible for the distal end direction of the section and extend towards being responsible for behind the inner chamber of section. The integrated intraoperative stent provided by the invention solves the problems of internal leakage and displacement risks existing in the prior art due to the split arrangement of the stent and the artificial blood vessel after implantation.

Description

Integrated intraoperative stent

Technical Field

The invention relates to the technical field of medical instruments, in particular to an integrated intraoperative stent.

Background

The aortic lesions of the affected arch mainly include dissect and aneurysm, and can be combined or not combined with lesions of other parts of the aorta, and the main treatment modes include fully open operation under deep low temperature stop and circulation, namely aortic arch artificial blood vessel replacement, aortic intraluminal repair represented by chimney technology, windowing technology and branch stent technology, and Hybrid operation combining surgical open operation and minimally invasive intraluminal repair technology, namely Hybrid technology.

Wherein, the fully open operation has complicated operation and long operation time due to the related deep low temperature circulation, and the traditional aortic arch artificial blood vessel replacement still has higher perioperative mortality and complication incidence for the elderly, high-risk and complicated patients.

The curative effect of the aortic endoluminal repair is restricted by the experience and learning curve of the operator, lacks the evidence of long-term follow-up, and has the possibility of adverse results of vessel reverse tearing, internal leakage, branch occlusion and the like at the near/far stage. At present, the full-cavity technology is not suitable for being comprehensively popularized and applied to the treatment of aortic arch part lesion.

The Hybrid technology combines the open surgery and the minimally invasive intracavity repair technology, and on one hand, an exact and safe anchoring area can be obtained by a surgical means; on the other hand, the surgical trauma can be greatly reduced or the surgical time can be shortened by means of the intracavity repair technology. However, the technology adopts surgical and interventional methods to jointly treat the focus or respectively treat the focus of different parts, the requirement on the matching degree of the surgical and interventional methods is high, a hospital is required to be equipped with a hybridization operating room, many hospitals do not have the condition for carrying out the hybridization operation at present, the surgical and interventional technical levels of each center are different, the surgical and interventional fusion capacities of doctors are different, and the site conditions are different, so that the technology becomes a barrier for carrying out and popularizing the Hybrid technology.

The existing Hybrid surgery based on Hybrid technology comprises a surgery mode of reversely pushing a stent system from an infusion port, and the surgery mode can avoid pushing an interventional stent from a femoral artery in the Hybrid surgery, but the surgery mode at least has the following problems:

(1) The stent and the artificial blood vessel are separated, and the risk of internal leakage and displacement exists after the stent is implanted; (2) Part of interlayer patients may undergo secondary operations of distal diseased vessels, the distal end of the stent needs to be sutured with a new artificial vessel during the secondary operations, the risk of displacement of the stent is increased in the suturing process, in addition, the stent needs to be integrally arranged in a delivery sheath, in order to ensure the diameter of a smaller delivery sheath, a film of the stent needs to be a film with smaller thickness, but the film with smaller thickness has low strength after being sutured, is easy to leak and is not suitable for the secondary operations in the later period; (3) Hybrid surgery requires visualization and is performed in a Hybrid operating room.

Disclosure of Invention

The invention aims to provide an integrated intraoperative stent to solve the problems of internal leakage and displacement risks existing after the stent and an artificial blood vessel are arranged in a split mode in the prior art.

In order to solve the technical problems, the technical scheme provided by the invention is as follows:

in a first aspect, the present invention provides an integrated intraoperative stent comprising: artificial blood vessels, tectorial membranes and supporting frameworks;

the artificial blood vessel comprises a main pipe section, the near end of the covering membrane is continuously or discontinuously connected with the peripheral surface of the main pipe section close to the far end along the circumferential direction of the main pipe section, the supporting framework is positioned at the inner side of the covering membrane, and the far end side of the supporting framework is connected with the far end side of the covering membrane;

the side wall of the main pipe section is provided with a conveying port communicated with the inner cavity of the main pipe section, the conveying port is used for pulling the supporting framework out of the inner cavity of the main pipe section to the outside of the main pipe section, and the supporting framework which extends out of the conveying port and is in a compression state extends towards the far end direction of the main pipe section after entering the inner cavity of the main pipe section.

Further, the proximal end of the support scaffold is located proximal to the proximal edge of the cover membrane.

Furthermore, the supporting framework is of an integrated structure.

Furthermore, the artificial blood vessel further comprises a branch pipe section, wherein the branch pipe section comprises at least one main branch pipe section, the near end of the main branch pipe section is connected to the side surface of the main pipe section, and the inner cavity of the main branch pipe section is communicated with the inner cavity of the main pipe section and is used for matching with the arch branch blood vessel to carry out branch blood supply.

Furthermore, the branch pipe sections further comprise at least one side branch pipe section, the proximal ends of the side branch pipe sections are connected to the side surface of the main branch pipe section and are communicated with the main branch pipe section, and the diameter of the proximal end of the main branch pipe section is larger than that of the distal end of the main branch pipe section.

Furthermore, a pipe fitting structure made of flexible materials is arranged on the conveying opening, and the inner cavity of the pipe fitting structure is communicated with the inner cavity of the main pipe section.

Furthermore, a hemostatic valve is connected to one end of the delivery port, which is far away from the main pipe section.

In a second aspect, the present invention provides a stent implantation method for implanting the integrated intraoperative stent of the first aspect into a patient, the stent implantation method comprising:

the preparation method comprises the following steps: preparing the integrated intraoperative stent, and ensuring that the integrated intraoperative stent is in a state that the supporting framework is pulled out of the outer part of the main pipe section from the inner cavity of the main pipe section, wherein the supporting framework is in a compressed state, and the covering film is in an overturning state that the inner cavity is overturned to the outer side;

implanting the artificial blood vessel: replacing the ascending aorta of the patient with the artificial blood vessel, and performing end-to-end anastomosis on the proximal end and the distal end of the artificial blood vessel and the autologous blood vessel;

a guide wire inserting step: a guide wire penetrates into the main pipe section from the delivery port through the inner part of the support framework in a compressed state and an inner cavity formed by the outer wall of the coating film, finally reaches the aortic arch part or the descending aorta, and is positioned in a true cavity through ultrasound;

conveying a covering film and supporting a framework: the film is conveyed into a conveyor through the conveying opening along the guide wire, and the film is turned over again until the film is pushed to an axial extension state along with the conveyor;

releasing the supporting framework: fixing the covering film and the far end of the supporting framework, releasing the supporting framework by using the conveyor, and radially expanding the covering film by using the supporting framework;

and a pullback conveyor: and after the supporting framework is completely released, the conveyor is withdrawn, and the conveying opening is blocked and sewn.

Further, in the stent implanting method, the preparing step further includes a loading step of: pre-installing the support framework inside the conveying outer pipe, withdrawing the conveying outer pipe so as to pull the support framework out of the main pipe section from the conveying opening, turning the coating film, pulling the far end of the coating film out of the main pipe section from the conveying opening, and enabling the coating film and the support framework to be located at different axial positions of the conveying outer pipe;

in the step of conveying the film and the supporting framework, the conveying outer pipe enters the inner cavity of the main pipe section from the conveying opening and presses the supporting framework towards the far end direction of the main pipe section so as to turn over and axially expand the film;

in the step of releasing the supporting framework, the conveying outer tube is withdrawn so as to release the supporting framework.

Furthermore, the conveyor is provided with a guide wire hole, and in the guide wire inserting step, the guide wire penetrates through the guide wire hole at the handle end of the conveyor and penetrates out of the conveying opening to finally reach the aortic arch part or the true cavity of the descending aorta.

The embodiment of the invention brings the following beneficial effects:

because the invention provides an integrated intraoperative stent, comprising: artificial blood vessels, tectorial membranes and supporting frameworks; the artificial blood vessel comprises a main pipe section, the near end of the covering membrane is continuously or discontinuously connected with the peripheral surface of the main pipe section close to the far end along the circumferential direction of the main pipe section, the supporting framework is positioned at the inner side of the covering membrane, and the far end side of the supporting framework is connected with the far end side of the covering membrane; be equipped with on the lateral wall of being responsible for the section with be responsible for the delivery port of section inner chamber intercommunication, the delivery port is used for pulling out the inner chamber that supports the skeleton from being responsible for the section to being responsible for the section outside to and, supply to stretch out and extend towards the distal end direction of being responsible for the section behind the inner chamber that the support skeleton that is in compression state outside the delivery port got into to be responsible for the section.

The invention also provides a stent implantation method for implanting the integrated intraoperative stent into a patient, which comprises the following steps: the preparation method comprises the following steps: preparing an integrated intraoperative stent, ensuring that the integrated intraoperative stent is in a state that a support framework is pulled out of the outer part of a main pipe section from an inner cavity of the main pipe section, wherein the support framework is in a compressed state, and a covering membrane is in an overturning state that the inner cavity is overturned to the outer side; implanting the artificial blood vessel: replacing the ascending aorta of the patient with the artificial blood vessel, and performing end-to-end anastomosis on the proximal end and the distal end of the artificial blood vessel and the autologous blood vessel; a guide wire inserting step: the guide wire penetrates into the main pipe section from the delivery port through the inner part of the support framework in a compressed state and an inner cavity formed by the outer wall of the covering membrane, finally reaches the aortic arch part or descending aorta, and the guide wire is determined to be positioned in the true cavity through ultrasound; conveying a covering film and supporting a framework: feeding the film to a conveyor through a conveying port along the guide wire, and turning the film again until the film is pushed to an axial extension state along with the conveyor; releasing the supporting framework: fixing the covering film and the far end of the supporting framework, releasing the supporting framework by using a conveyor, and radially expanding the covering film by using the supporting framework; and a pullback conveyor: and after the supporting framework is completely released, the conveyor is withdrawn, and the conveying opening is blocked and sewn.

The effect that sets up support chassis lies in, can play the supporting role to the tectorial membrane, prevents that blood from palirrhea from strikeing the tectorial membrane, and what can be better after support chassis releases makes the tectorial membrane expand to and can make real chamber expand rapidly. The lateral wall of being responsible for the section sets up the effect of carrying the mouth and lies in, can pull out the support chassis and be responsible for the section outside to and, make support chassis get into and be responsible for the distal end direction extension of the section towards being responsible for behind the inner chamber of section through the mouth when carrying support chassis.

For the A-type aortic dissection, the conventional operation mode is a fully open operation, the descending aorta anastomosis port, the far end of the artificial blood vessel and the near end of the supporting framework need to be anastomosed in the operation process, the deep hypothermia and the stop circulation are involved, the operation time is long, the process is complex, the Hybrid operation mode is adopted in the application, the stop circulation is not involved, the operation process is simple, and the injury to a patient is small. Just the utility model provides an integral type support in art, because the near-end of tectorial membrane is in being responsible for the circumferential direction of section and connecting in being close to global of distal end along being responsible for the circumference of section, and the support chassis is located the inboard of tectorial membrane, and the distal end side of support chassis is connected with the distal end side of tectorial membrane, therefore artificial blood vessel, the structure of integral type has been constituteed jointly to tectorial membrane and support chassis, no longer need coincide artificial blood vessel distal end and support chassis near-end in the art, in the aspect of the postoperative effect, the structure of integral type does not have interior hourglass, the risk of aversion, more stable long-term effect has. In addition, the artificial blood vessel, the film and the supporting framework which are integrated do not relate to the problem of inaccurate positioning of a split type in the operation process, and the supporting framework can be released only by pushing the conveyor to the bottom. Because the guide wire is determined to be positioned in the true cavity through ultrasound in the operation, the accurate release of the support framework is ensured, and the re-angiography in the operation is not needed, and the operation is not needed in a hybrid operation room.

In addition, because the supporting framework is connected with the film, the film is connected with the peripheral face of the far end of the main pipe section, and the supporting framework can be pulled out from the inner cavity of the main pipe section at the position of the conveying opening, so that the film and the supporting framework are not required to be integrally filled into the conveyor when the supporting framework is conveyed, the supporting framework is only required to be filled into the conveyor, the film is not required to be filled into the conveyor, the compression volume is reduced, and the pushing and the releasing are convenient. Under the same or even smaller delivery outer tube, a film with larger thickness can be adopted, thereby facilitating the suture of the secondary operation in the later period.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention or related technologies, the drawings used in the description of the embodiments or related technologies will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural diagram of an integrated intraoperative stent provided by an embodiment of the present invention;

FIG. 2 is a schematic view of a main tubular segment of an artificial blood vessel after suturing in accordance with an embodiment of the present invention;

FIG. 3 is a schematic view of a branch tube of an artificial blood vessel provided by an embodiment of the present invention after suturing;

FIG. 4 is a schematic view of a guidewire insertion procedure provided by an embodiment of the present invention;

FIG. 5 is a schematic illustration of a step of delivering a cover and support scaffold provided by an embodiment of the present invention;

FIG. 6 is a schematic illustration of a step of releasing the support scaffold according to an embodiment of the present invention;

fig. 7 is a schematic view of the integrated intraoperative stent provided by the embodiment of the invention after implantation is completed.

Icon:

100-artificial blood vessel; 110-a main pipe section; 120-trunk branch pipe section; 130-side branch sections; 140-a delivery port; 150-a hemostatic valve; 200-coating a film; 300-supporting a framework; 400-a guide wire; 500-conveyor.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. 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. The physical quantities in the formula, if not individually labeled, are to be understood as basic quantities of the international system of units, or derived quantities derived from the basic quantities by mathematical operations such as multiplication, division, differentiation or integration.

Furthermore, the terms "horizontal", "vertical", "suspended" and the like do not imply that the components are absolutely horizontal or suspended, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in a specific case to those of ordinary skill in the art.

In particular, in the present invention, the term "proximal" refers to the end closer to the human heart during surgery, and "distal" refers to the end opposite the "proximal".

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

Example one

The prior Hybrid surgery based on Hybrid technology at least has the following problems: the stent and the artificial blood vessel are separated, and the risk of internal leakage and displacement exists after the stent is implanted; partial interlayer patients may carry out secondary operation on a far-end diseased blood vessel, the far end of the stent and a new artificial blood vessel need to be sutured during the secondary operation, the risk of displacement of the stent is increased in the suturing process, in addition, the stent needs to be integrally arranged in a conveying sheath, in order to ensure the diameter of a smaller conveying sheath tube, a film of the stent needs to be a film with smaller thickness, but the film with smaller thickness has low strength after suturing, is easy to leak and is not suitable for the secondary operation in the later period; hybrid surgery requires visualization and is performed in a Hybrid operating room.

In view of the above, an embodiment of the present invention provides an integrated intraoperative stent, including: the artificial blood vessel 100, the covering film 200 and the supporting framework 300; the artificial blood vessel 100 comprises a main tube segment 110, the proximal end of the covering membrane 200 is continuously or discontinuously connected to the peripheral surface of the main tube segment 110 near the distal end at multiple points along the circumference of the main tube segment 110, the supporting framework 300 is positioned at the inner side of the covering membrane 200, and the distal side of the supporting framework 300 is connected with the distal side of the covering membrane 200; be equipped with on the lateral wall of main pipe section 110 with the delivery port 140 of main pipe section 110 inner chamber intercommunication, delivery port 140 is used for pulling out support frame 300 from the inner chamber of main pipe section 110 outside main pipe section 110 to and, the support frame 300 that supplies to stretch out outside delivery port 140 and be in the compression state extends towards the distal direction of main pipe section 110 after entering the inner chamber of main pipe section 110.

The support skeleton 300 is arranged to support the covering membrane 200, prevent blood from reversely flowing and impacting the covering membrane 200, enable the covering membrane 200 to be better unfolded after the support skeleton 300 is released, and enable the true cavity to be rapidly expanded. The function of providing the delivery opening 140 on the side wall of the main tubular segment 110 is to pull the support framework 300 out of the main tubular segment 110, and to enable the support framework 300 to enter the inner cavity of the main tubular segment 110 and extend towards the distal direction of the main tubular segment 110 through the delivery opening 140 when delivering the support framework 300.

For the A-type aortic dissection, the conventional operation mode is a fully open operation, the descending aorta anastomosis opening, the far end of the artificial blood vessel 100 and the near end of the supporting framework 300 need to be anastomosed in the operation process, the deep hypothermia and the stopping circulation are involved, the operation time is long, the process is complex, the Hybrid operation mode is adopted in the application, the stopping circulation is not involved, the operation process is simple, and the injury to a patient is small. And the support in integral type art that this application provided, because the near-end of tectorial membrane 200 is connected in the peripheral face that is close to the distal end of main pipe section 110 along the circumference of main pipe section 110, and support skeleton 300 is located the inboard of tectorial membrane 200, and the distal end side of support skeleton 300 is connected with the distal end side of tectorial membrane 200, therefore artificial blood vessel 100, tectorial membrane 200 and support skeleton 300 constitute the structure of integral type jointly, no longer need coincide artificial blood vessel 100 far-end and support skeleton 300 near-end in the art, in the aspect of the postoperative effect, the structure of integral type does not have the risk of inner leakage, the aversion, have more stable long-term effect. In addition, the integrated artificial blood vessel 100, the covering film 200 and the support framework 300 can release the support framework 300 only by pushing the conveyor 500 to the bottom without the problem of inaccurate positioning in a split manner in the operation process. Since the guide wire 400 is determined to be located in the true lumen by ultrasound during the operation, accurate release of the support frame 300 is ensured, and re-angiography during the operation is not needed, and the operation is not needed in a hybrid operation room.

In addition, because the support framework 300 is connected with the covering film 200, the covering film 200 is connected with the peripheral surface of the far end of the main pipe section 110, and the support framework 300 can be pulled out from the inner cavity of the main pipe section 110 from the delivery port 140, the covering film 200 and the support framework 300 do not need to be integrally installed in the conveyor 500 when the support framework 300 is delivered, the support framework 300 only needs to be installed in the conveyor 500, the covering film 200 does not need to be installed in the conveyor 500, the compression volume is reduced, and pushing and releasing are facilitated. Under the same or even smaller diameter of the outer delivery tube, the covering film 200 with larger thickness can be adopted, thereby facilitating the suture of the secondary operation in the later period.

The distal end of the artificial blood vessel 100 is provided with a skirt, the proximal end of the skirt is connected to the distal end of the main tube section 110 of the artificial blood vessel 100, the diameter of the distal end of the skirt is larger than that of the proximal end of the skirt, and the distal end of the skirt is a free end. The skirt edge is used for being anastomosed with the distal end of the ascending aorta, and when the diameter of the distal end of the ascending aorta is larger, the skirt edge and the distal end of the ascending aorta with large diameter can be conveniently sewn at the end. In addition, the far end can also be provided with a support ring which is matched with a suture-free buckle ring or a binding wire, so that the aim of avoiding suture at the far end is fulfilled.

The overlay film 200 and the main tube segment 110 may be connected in the following two ways: the first is to continuously connect the proximal end of the membrane 200 to the circumferential surface of the main tube segment 110 near the distal end along the circumferential direction of the main tube segment 110, and specifically, a circumferential complete-fitting connection method may be adopted, which can firmly connect the membrane 200 and the main tube segment 110, and the membrane 200 and the main tube segment 110 will not fall off and separate after a long period of operation. The second is to connect the proximal end of the film 200 to the peripheral surface of the main pipe segment 110 near the distal end intermittently at multiple points along the circumference of the main pipe segment 110, specifically, a circumferential multi-point fixed connection method may be adopted, usually 3 to 8 fixed points may be selected in the circumference, the fixed points may be selected uniformly or non-uniformly along the circumference, and this connection method can simply and rapidly connect the film 200 to the main pipe segment 110, and at the same time, saves the cost.

Referring to fig. 1, the covering membrane 200 is wrapped outside the support framework 300, and the distal end of the covering membrane 200 is fixedly connected to the distal end of the support framework 300, and a suture fixing manner may be adopted, so that an accommodating space for inserting the delivery outer tube is formed between the support framework 300 and the covering membrane 200. Through insert the transport outer tube between supporting framework 300 and tectorial membrane 200, after withdrawing the transport outer tube, supporting framework 300 can pull out outside being responsible for section 110 from delivery port 140, tectorial membrane 200 upset and tectorial membrane 200's distal end also pull out outside being responsible for section 110 from delivery port 140, need not to pack tectorial membrane 200 and supporting framework 300 wholly into in conveyer 500 when carrying supporting framework 300, only need pack into conveyer 500 with supporting framework 300 in, the compression volume has been reduced, be convenient for propelling movement and release, under the transport outer tube of same diameter, can adopt the great tectorial membrane of thickness, the secondary operation in later stage is conveniently sewed up.

Further, the proximal end of the support frame 300 may be disposed on the proximal side of the proximal edge of the cover film 200. The benefit that sets up like this lies in, support chassis 300 stretches into main pipe section 110 and is closer to the near-end in comparison with tectorial membrane 200, can wholly play the supporting role to tectorial membrane 200, prevents that tectorial membrane 200 from taking place the fold, has further strengthened the effect of preventing the palirrhea impact tectorial membrane 200 of blood, can avoid implanting back support chassis 300 simultaneously and support at lesion area blood vessel for support chassis 300 supports in healthy artificial blood vessel 100.

In an alternative of this embodiment, the supporting frame 300 is a one-piece structure. Specifically, the support frame 300 includes a plurality of stent rings disposed along an axial direction, and the stent rings are connected to each other by stitches or wires. In addition, the support frame 300 may be a mesh woven type or a laser engraved type, as long as it is an integrated frame. The support framework 300 with the integrated structure can meet the strength requirement during conveying and releasing, and smooth implantation of the support framework 300 is guaranteed.

In an optional manner of this embodiment, the artificial blood vessel 100 further includes branch tube segments, the branch tube segments include at least one main branch tube segment 120, the proximal end of the main branch tube segment 120 is connected to the side surface of the main tube segment 110, and the inner cavity of the main branch tube segment 120 is communicated with the inner cavity of the main tube segment 110 for performing branch blood supply in anastomosis with the arch branch blood vessel.

Since the artificial blood vessel 100 is to be anastomosed to the ascending aorta end in the operation, the artificial blood vessel 100 needs to include a branch tube section for anastomosing the arch branch. The main branch tube segment 120 is communicated with the inner cavity of the main tube segment 110, and blood flows from the main tube segment 110 through the main branch tube segment 120 to other branch tube segments. The branch pipe sections may comprise one main branch pipe section 120 or two main branch pipe sections 120 each originating from the main pipe section 110.

Further, the branch pipe sections further include at least one side branch pipe section 130, a proximal end of the side branch pipe section 130 is connected to a side surface of the main branch pipe section 120 and is communicated with the main branch pipe section 120, and a proximal end diameter of the main branch pipe section 120 is larger than a distal end diameter.

Referring to fig. 3, the branch tube segment may include only one side branch tube segment 130, and the arch branch without the side branch tube segment 130 anastomoses is communicated with the branch tube segment by means of a bridge or the like to ensure blood supply; the branch tube segments may further include two side branch tube segments 130, and a main branch tube segment 120 and the two side branch tube segments 130 are respectively anastomosed with the arch three branches. In an alternative form of this embodiment, the main tube segment 110 has a diameter in the range of 20-40mm and a length in the range of 40-60mm, the main branch tube segment 120 has a diameter in the range of 10-20mm, and the side branch tube segments 130 have a diameter in the range of 8-12mm. The proximal diameter of the main branch tube section 120 is larger than the distal diameter, so that the blood can still meet the blood supply of the arch branch anastomotic with the main branch tube section 120 after being shunted by the branch tube section 130 in the process that the blood flows from the proximal end to the distal end of the main branch tube section 120. Preferably, the main branch tube segment 120 may be tapered with a proximal diameter of 20mm and a distal diameter of 10mm.

Furthermore, the individual branch tube sections may also be constructed identically to a conventional vessel, i.e. with the main tube section 110 connected in each case at the starting position.

In an optional manner of this embodiment, a tube structure made of a flexible material is disposed on the delivery port 140, and an inner cavity of the tube structure is communicated with an inner cavity of the main tube segment 110. Specifically, the delivery port 140 may be a section of pipeline or may be directly disposed on a vessel wall of the main pipe segment 110, and the delivery port 140 is a flexible structure, so that the pushing angle of the conveyor 500 can be conveniently adjusted, and the transportation of the support frame 300 and the coating film 200 is facilitated. The end of the delivery port 140 away from the main tubular segment 110 is connected to a hemostatic valve 150 to prevent blood leakage during the pushing process of the delivery device 500.

Example two

The embodiment provides a stent implanting method for implanting the integrated intraoperative stent in a patient, which comprises the following steps:

the preparation method comprises the following steps: preparing an integrated intraoperative stent, ensuring that the integrated intraoperative stent is in a state that the support framework 300 is pulled out of the outer part of the main tube section 110 from the inner cavity of the main tube section 110, wherein the support framework 300 is in a compression state, and the covering membrane 200 is in an overturning state that the inner cavity is overturned to the outer side. Specifically, the conveying outer pipe can be inserted between the supporting framework 300 and the coating film 200, after the conveying outer pipe is withdrawn, the supporting framework 300 is pulled out from the conveying port 140 to the outside of the main pipe section 110, at the moment, the coating film 200 is overturned, the far end of the coating film 200 is also pulled out from the conveying port 140 to the outside of the main pipe section 110, the coating film 200 and the supporting framework 300 are located at different axial positions of the conveying outer pipe, the original inner cavity of the coating film 200 is overturned, and the original outer side can be overturned to the inner side. When loading, only the support framework 300 needs to be arranged in the delivery outer tube, the coating 200 does not need to be arranged in the delivery outer tube, or the distal end part of the coating 200 can be arranged in the delivery outer tube, but the compression volume cannot be increased due to different axial positions of the coating 200 and the support framework 300 in the delivery outer tube. In addition, the outer tube may be replaced by a conventional scheme such as compressing a film sleeve or binding a wire, and the wire may be released as long as the support frame 300 is controlled to be released.

Implanting the artificial blood vessel: the patient's ascending aorta is replaced with an artificial blood vessel 100, and the proximal and distal ends of the artificial blood vessel 100 are end-to-end anastomosed to the autologous blood vessel, see fig. 2. Before implantation, artery insertion tubes such as axillary arteries, innominate arteries or femoral arteries and right atrial vein insertion tubes are selected according to team experience and pathological change characteristics, extracorporeal circulation is established, heartbeat is stopped, the proximal end and the distal end of the ascending aorta are blocked by blocking forceps, the ascending aorta is cut, and end-to-end matching is respectively carried out on the proximal end and the distal end of the main tube section 110. Then, the heartbeat is restored, the artificial blood vessel 100 is deflated, the extracorporeal circulation is stopped, the blood supply to the heart is restored, and the arch branch and the branch tube segments are sutured in sequence from the proximal end to the distal end, one open branch is sutured, see fig. 3.

A guide wire inserting step: the guidewire 400 is threaded through the interior of the support frame 300 in a compressed state and through the lumen formed by the outer wall of the covering membrane 200 from the delivery port 140 into the main tubular segment 110 and ultimately to the aortic arch or descending aorta, and the guidewire 400 is ultrasonically identified as being within the true lumen. The delivery device 500 is provided with a guide wire hole, specifically, the guide wire 400 is inserted into the guide wire hole at the tail end of the handle of the delivery device 500, and the guide wire 400 finally extends into the aortic arch or the true lumen of the descending aorta through the delivery port 140, as shown in fig. 4.

Conveying a covering film and supporting a framework: the graft 200 is again inverted by being fed along the guidewire 400 through the delivery port 140 and into the conveyor 500 until the graft 200 is pushed with the conveyor 500 to an axially extended condition. After the conveyor 500 is conveyed to the right position, the conveying outer tube enters the inner cavity of the main tube section 110 from the conveying opening 140, and presses the supporting framework 300 towards the distal direction of the main tube section 110, so as to turn over and axially expand the coating 200. The covering membrane 200 is turned over to a normal state, that is, the inner cavity of the covering membrane 200 returns to the inside, and is axially tensioned and flattened, so that the support framework 300 and the delivery outer tube are both located inside the inner cavity of the covering membrane 200, please refer to fig. 5.

Releasing the support framework: the distal ends of the covering membrane 200 and the support frame 300 are fixed, the support frame 300 is released by the conveyor 500, and the support frame 300 radially bulges the covering membrane 200. Through the fixed tectorial membrane 200 of conveyer 500 or the distal end of support skeleton 300, under the circumstances that support skeleton 300 is not shortened, can also support the support skeleton 300 near-end through middle pipe to guarantee that tectorial membrane 200 and support skeleton 300 distal end are fixed in the release in-process, prevent that support skeleton 300 distal end from taking place to shift. The delivery outer tube is withdrawn to release the supporting framework 300, and the fixed end is released after the supporting framework 300 is released, so that the ideal effect after release is that the far end of the covering membrane 200 is pushed in place without shortening, the supporting framework 300 extends axially, the near end is positioned near the connecting part of the main tube section 110 and the covering membrane 200, and the supporting framework 300 does not shorten, as shown in fig. 6.

And a pullback conveyor: the support frame 300 is completely released and then withdrawn from the transporter 500, the delivery port 140 is blocked and sutured, the excess is cut off, and hemostasis and post-operative care are sutured, as shown in fig. 7.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An integrated intraoperative stent, comprising: artificial blood vessels, tectorial membranes and supporting frameworks;

the artificial blood vessel comprises a main tube section, the near end of the covering membrane is continuously or discontinuously connected with the peripheral surface of the main tube section close to the far end along the circumferential direction of the main tube section, the supporting framework is positioned on the inner side of the covering membrane, and the far end side of the supporting framework is connected with the far end side of the covering membrane;

a conveying port communicated with the inner cavity of the main pipe section is formed in the side wall of the main pipe section, and the conveying port is used for pulling the support framework out of the inner cavity of the main pipe section to the outside of the main pipe section and enabling the support framework which extends out of the conveying port and is in a compressed state to enter the inner cavity of the main pipe section and then extend towards the far end direction of the main pipe section;

in a preparation state, the supporting framework is pulled out of the main pipe section from the inner cavity of the main pipe section, the supporting framework is in a compressed state, and the film is in an overturning state that the inner cavity is overturned to the outer side;

in the operation, the film is conveyed into the conveyor through the conveying opening, the film is turned over again until the film is pushed to an axially extending state along with the conveyor, and the supporting framework radially bulges the film.

2. The integrated intraoperative stent of claim 1, wherein the proximal end of the support scaffold is located on the proximal side of the proximal edge of the cover.

3. The integrated intraoperative stent of claim 1, wherein the support skeleton is an integrated structure.

4. The integrated intraoperative stent according to claim 1, wherein the artificial blood vessel further comprises branch tube sections, each branch tube section comprises at least one main branch tube section, the proximal end of each main branch tube section is connected to the side surface of the main tube section, and the inner cavity of each main branch tube section is communicated with the inner cavity of the main tube section and is used for anastomosing with an arch branch blood vessel to supply branch blood.

5. The integrated intraoperative stent of claim 4, wherein the branch tube segments further comprise at least one side branch tube segment, the proximal end of the side branch tube segment is connected to the side of the main branch tube segment and communicates with the main branch tube segment, the proximal end diameter of the main branch tube segment is larger than the distal end diameter.

6. The integrated intraoperative stent according to claim 1, wherein a pipe structure made of a flexible material is arranged on the delivery port, and the inner cavity of the pipe structure is communicated with the inner cavity of the main pipe section.

7. The integrated intraoperative stent of claim 1 or 6, wherein a hemostatic valve is connected to one end of the delivery port remote from the main tube section.