CN114767328A - Medical system and auxiliary device - Google Patents

Abstract

The invention provides a medical system comprising: artificial blood vessels, including major blood vessels; the covered stent comprises a main stent, wherein the near end of the main stent is used for being connected with the far end of the main vessel; the auxiliary device comprises a first bare stent, an isolation sleeve and a binding piece; the first bare stent is arranged at the far end of the main blood vessel or the near end of the main stent; the distal end of the isolation sleeve is sleeved at the distal end of the main blood vessel or the proximal end of the main support, the isolation sleeve comprises a turnover section, the turnover section is used for being turned outwards, the turnover section is located on the proximal end side of the first bare support before being turned, and after being turned, the turnover section and the first bare support are at least partially overlapped in the axial direction; the isolation sleeve comprises a binding sleeve and an isolation sleeve body, a plurality of positioning holes are formed in the binding sleeve and are circumferentially arranged, at least part of the positioning holes are located on the turnover section, and the isolation sleeve body is sleeved on the outer side of the binding sleeve; the binding piece is positioned on the turnover section and penetrates through at least part of the positioning hole. The medical system is used for full-arch trunk operation, and shortens the time of deep hypothermia circulation stopping.

Description

Medical system and auxiliary device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical system and an auxiliary device.

Background

Aortic dissection is a serious life-threatening health cardiovascular disease with extremely high clinical complications and mortality, with acute aortic dissection having a mortality rate of about 33% within 24 hours, a mortality rate of about 50% within 48 hours, and a mortality rate of up to about 90% within 3 months. The worse prognosis for complex aortic dissection involving the ascending aorta, aortic arch, and descending aortic surface, the treatment of which is a significant challenge in cardiovascular surgery.

With the continuous development of treatment technology and the accumulation of experience, the combination of full aortic arch replacement and descending aorta stent-rhinoplasty (full arch rhinoplasty for short) has become a standard surgical scheme for treating aortic dissection involving the aortic arch. The existing full-arch elephant nose operation needs to be carried out under the assistance of a deep low temperature circulation stopping technology, and the suturing time is longer due to the fact that the suturing difficulty between the covered stent and the autologous blood vessel is larger, so that the deep low temperature circulation stopping time is longer, and the ischemia and hypoxia injury of each visceral organ of the whole body is increased. In addition, after the circulation is restored, bleeding is easily generated at the anastomotic site of the stent graft and the autologous blood vessel due to the influence of hemodynamics, and a doctor is required to perform suture repair.

Disclosure of Invention

The invention aims to provide a medical system and an auxiliary device, aiming at shortening the time of deep low temperature circulation stopping when a full-arch elephant nose operation is executed, improving the sealing property between a covered stent and an autologous blood vessel and reducing the bleeding amount at an anastomotic part.

To achieve the above object, the present invention provides a medical system comprising:

artificial blood vessels, including major blood vessels;

the covered stent comprises a main stent, wherein the near end of the main stent is used for being connected with the far end of the main vessel; and the number of the first and second groups,

the auxiliary device comprises a first bare stent, an isolation sleeve and a binding piece; the first bare stent is disposed on a distal circumferential face of the main vessel or a proximal circumferential face of the main stent; the isolating sleeve is sleeved at the far end of the main blood vessel or the near end of the main support and comprises a turning section, the turning section is used for turning outwards, the turning section is located at the near end side of the first naked support before the turning section is turned, and after the turning section is turned, the turning section is at least partially overlapped with the first naked support in the axial direction; the isolation sleeve comprises a binding sleeve and an isolation sleeve body, a plurality of positioning holes are formed in the binding sleeve at intervals along the circumferential direction, at least part of the positioning holes are located on the turnover section, and the isolation sleeve body is sleeved on the outer side of the binding sleeve; the binding piece is located on the turnover section and penetrates through at least part of the positioning holes.

Optionally, the primary stent and the first bare stent are for insertion into a target lumen; the medical system is configured to: when the first bare stent is inserted into the target lumen and the turning section turns outwards, the turning section covers the outer peripheral surface of the near end of the target lumen, and the binding piece is used for tightening so that the radial size of the turning section at the position of the binding piece is reduced and tightly hooped on the outer peripheral surface of the near end of the target lumen.

Optionally, the first bare stent is arranged at the distal end of the main blood vessel, and the isolation sleeve is sleeved on the outer peripheral surface of the distal end of the main blood vessel; or the first bare stent is arranged at the proximal end of the main stent, and the isolation sleeve is sleeved at the proximal end of the main stent; or the first bare stent is arranged at the near end of the main stent, and the isolation sleeve is sleeved on the outer peripheral surface of the far end of the main blood vessel.

Optionally, when the first bare stent is disposed at the proximal end of the main stent and the isolation sleeve is sleeved at the proximal end of the main stent, the proximal end of the first bare stent is flush with the proximal end of the main stent.

Optionally, the primary stent comprises a second bare stent and a cover; when the first bare stent is arranged at the proximal end of the main stent, the proximal end of the covering membrane exceeds the proximal end of the second bare stent, and the first bare stent is arranged on the part of the covering membrane exceeding the second bare stent.

Optionally, the distal end of the main vessel is connected to the proximal end of the main stent, and the folded section is sleeved on the outer peripheral surface of the distal end of the main vessel.

Optionally, the radial dimension of the restraining sheath and the radial dimension of the isolation sheath body both decrease in a proximal to distal direction.

Optionally, the binding member includes a strip-shaped structure, the positioning hole is a strip-shaped hole extending along the axial direction of the binding sleeve, the axial dimension of the positioning hole is greater than or equal to the width of the binding member, and the circumferential dimension of the positioning hole is greater than or equal to the thickness of the binding member.

Optionally, the binding piece comprises a binding line, each positioning hole comprises a plurality of sub-positioning holes, the sub-positioning holes are arranged at intervals along the proximal end to the distal end, and the diameter of each sub-positioning hole is larger than or equal to the outer diameter of the binding line.

Optionally, the first bare stent is a cutting stent.

Optionally, a first window, a second window and a third window are opened on the side wall of the main blood vessel; the artificial blood vessel further comprises a first branch blood vessel, a second branch blood vessel and a third branch blood vessel; the proximal end of the first branch blood vessel is connected to the first window, the proximal end of the second branch blood vessel is connected to the second window, and the proximal end of the third branch blood vessel is connected to the third window.

Optionally, a fourth window and a fifth window are opened on the side wall of the main vessel, and the artificial vessel further includes a first branch vessel, a second branch vessel and a third branch vessel; the proximal end of the first branch blood vessel is connected to the fourth window, a sixth window is formed in the side wall of the first branch blood vessel, the proximal end of the second branch blood vessel is connected to the sixth window, and the third branch blood vessel is connected to the fifth window.

Optionally, a seventh window is formed in the side wall of the main stent, the covered stent further includes a branch stent, and the proximal end of the branch stent is connected to the seventh window.

Optionally, at least one of the main vessel, the first branch vessel, the second branch vessel, and the third branch vessel is a bellows structure.

Optionally, the main stent has an outer diameter that tapers in a proximal to distal direction.

In order to achieve the purpose, the invention also provides an auxiliary device, which comprises a first naked bracket, an isolation sleeve and a binding piece; the first naked stent is used for being arranged at the far end of a main vessel of an artificial blood vessel or at the near end of a main stent of a covered stent; the separation sleeve is used for being sleeved at the far end of the main blood vessel or the near end of the main support, the separation sleeve comprises a turnover section, the turnover section is used for being turned outwards, the turnover section is located on the near end side of the first naked support before the turnover section is turned over, the turnover section is at least partially overlapped with the first naked support in the axial direction after the turnover section is turned over, the separation sleeve comprises a binding sleeve and a separation sleeve body, a plurality of positioning holes which are circumferentially arranged at intervals are formed in the binding sleeve, the positioning holes are at least partially located in the turnover section, and the separation sleeve body is sleeved on the outer side of the binding sleeve; the binding piece is arranged on the turnover section and penetrates through at least part of the positioning hole.

Compared with the prior art, the medical system, the auxiliary device, the artificial blood vessel component and the tectorial membrane support component have the following advantages: the medical system comprises an artificial blood vessel, a covered stent and an auxiliary device; wherein the artificial blood vessel comprises a main blood vessel, the tectorial membrane stent comprises a main stent, and the proximal end of the main stent is used for being connected with the distal end of the main blood vessel; the auxiliary device comprises a first bare stent, an isolation sleeve and a binding piece; the first bare stent is disposed at a distal end of the main vessel or a proximal end of the main stent; the isolating sleeve is sleeved at the far end of the main blood vessel or the near end of the main support, the isolating sleeve comprises a turnover section, the turnover section is used for being turned outwards, the turnover section is located at the near end side of the first naked support before the turnover section is turned, and after the turnover section is turned, the turnover section and the first naked support are at least partially overlapped in the axial direction; the isolation sleeve comprises a binding sleeve body and an isolation sleeve body, a plurality of positioning holes are formed in the binding sleeve body at intervals along the circumferential direction, at least part of the positioning holes are located on the turning sections, and the isolation sleeve body is sleeved on the outer side of the binding sleeve body; the binding piece is positioned on the turnover section and penetrates through at least part of the positioning hole. The medical system can be applied to a full-arch trunk operation, during the operation, the far end of the main blood vessel and the near end of the main support are used for being placed in an autologous blood vessel, then the turnover section is turned over, and the binding piece is tightened, so that the isolation sleeve can be wrapped at the near end part of the autologous blood vessel and tightly hooped on the outer surface of the autologous blood vessel, the covered stent and the autologous blood vessel can be positioned without sewing, the displacement is prevented, the circulation stopping time at the deep low temperature is shortened, the isolation sleeve body is tightly attached to the outer wall of the autologous blood vessel through the isolation of the isolation sleeve, and the bleeding amount of the anastomotic part of the far end of the autologous blood vessel can be reduced. And the autologous blood vessel is supported by the first bare stent, so that the turnover section of the isolation sleeve is supported, and the first bare stent can provide stronger radial supporting force when the binding piece is tightened, so that the autologous blood vessel cannot be pressed and closed.

Further, the distal end of the main vessel and the proximal end of the main stent can be connected before the operation without suturing in the operation process, so that the suturing time is shortened, and the time of the deep hypothermia stopping circulation is further shortened. Moreover, the artificial blood vessel comprises three branch blood vessels, wherein one branch blood vessel is used for extracorporeal circulation, the other two branch blood vessels are used for suturing the brachiocephalic trunk artery and the left common carotid artery, and the covered stent also comprises a branch stent which is used for being inserted into the left subclavian artery to enable the arcus anastomotic stoma to move forward, so that the depth dissociation of the left subclavian artery is avoided, and the operation difficulty is reduced; meanwhile, on the premise that the medical system has better universal applicability, the parts needing to be anastomosed in the full-arch trunk operation are reduced, the anastomosis time is shortened, and the operation time is further shortened.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention.

FIG. 1 is a schematic view of a medical system according to an embodiment of the present invention showing a first bare stent and a spacer sleeve attached to the proximal end of the main stent.

FIG. 2 is a schematic view of a medical system according to an embodiment of the present invention, showing a first bare stent and a spacer sleeve attached to the proximal end of the main stent, and showing the spacer sleeve body with material removed to reveal the constraining sleeve, locating holes, and constraining members.

FIG. 3 is a schematic view of a medical system according to an embodiment of the present invention showing a first bare stent and a separation sleeve attached to a main vessel.

Fig. 4 is a schematic diagram of a medical system provided in accordance with an alternative embodiment of the present invention.

Fig. 5 is a schematic structural view of a first bare stent of an ancillary device of a medical system according to one embodiment of the present invention.

Fig. 6 is a schematic structural diagram of a spacer sleeve of an auxiliary device of a medical system according to an embodiment of the invention, wherein an included angle between an outer peripheral surface of the spacer sleeve and an axis of the spacer sleeve is marked.

FIG. 7 is a schematic view of a spacer for a medical system according to an embodiment of the present invention with a portion of the material of the spacer body removed to reveal a constraining sheath.

Fig. 8 is a schematic diagram of a restraining sheath of an isolation sheath of a medical system according to an embodiment of the invention.

FIG. 9 is a schematic plan view of a restraining sheath of an isolation sheath of a medical system according to an embodiment of the present invention.

Fig. 10 is a schematic view of a restraining sheath of an isolation sheath of a medical system according to another embodiment of the invention.

FIG. 11 is a schematic plan view of a restraining sheath of a spacer sheath of a medical system according to another embodiment of the present invention.

Fig. 12a is a schematic view of a usage scenario of the medical system provided in fig. 1 and 2, wherein the folded section is not folded.

Fig. 12b is a view of the medical system of fig. 1 and 2 showing the folded section folded but the tether not tightened.

Fig. 12c is a view of the medical system of fig. 1 and 2 showing the folded section folded and the tether tightened, but the third branch vessel not ligated.

Fig. 12d is a view of the medical system of fig. 1 and 2 showing a third branch vessel ligated.

[ reference symbols are explained below ]: 100-a medical system, 1000-an artificial blood vessel, 1100-a main blood vessel, 1200-a first branch blood vessel, 1300-a second branch blood vessel, 1400-a third branch blood vessel, 2000-a tectorial membrane stent, 2100-a main stent, 2110-a second bare stent, 2120-a first tectorial membrane, 2200-a branch stent, 2210-a third bare stent, 2220-a second tectorial membrane, 3000-an auxiliary device, 3100-a first bare stent, 3110-a pore structure, 3200-an isolation sleeve, 3201-a turnover section, 3210-a binding sleeve, 3211-a positioning hole, 3211 a-a sub positioning hole, 3220-an isolation sleeve body and 3300-a binding piece; 10-descending aorta, 20-left subclavian artery, 30-ascending aorta, 40-brachiocephalic trunk, 50-left common carotid artery.

Detailed Description

The following embodiments of the present invention are provided by way of specific examples, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, based on the disclosure of the present invention and according to design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment or selectively implement some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility of the implementation of the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

The terms "proximal" and "distal" are defined herein as the distance of each component, element or action relative to the heart during actual use of the medical system, and although "proximal" and "distal" are not limiting, generally the "proximal" is the end of the medical system and its components closer to the heart and the "distal" is the end of the medical system and its components farther from the heart. Unless the content clearly dictates otherwise.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Referring to fig. 1 to 4, a medical system 100 according to an embodiment of the present invention includes an artificial blood vessel 1000, a stent graft 2000 and an auxiliary device 3000. Wherein the vascular prosthesis 1000 includes a main vessel 1100. The stent graft 2000 includes a main stent 2100, a proximal end of the main stent 2100 being adapted to be coupled to a distal end of the main vessel 1100. The accessory 3000 includes a first bare support 3100, a spacer 3200, and a restraint 3300. The first bare stent 3100 is disposed at a distal end of the main vessel 1100 or at a proximal end of the main stent 2100. The isolation sleeve 3200 is sleeved on the distal end of the main blood vessel 1100 or the proximal end of the main stent 1100, the isolation sleeve 3200 comprises a turnover section 3201, the turnover section 3201 is used for turning over outwards, the turnover section 3201 is located on the proximal end side of the first bare stent 3100 before the turnover section 3201 is turned over, and after the turnover section 3201 is turned over, the turnover section 3201 and the first bare stent 3100 are at least partially overlapped in the axial direction. The isolation sleeve 3200 comprises a binding sleeve 3210 and an isolation sleeve body 3220, a plurality of positioning holes 3211 are formed in the binding sleeve 3210 and are circumferentially arranged at intervals, the positioning holes 3211 are at least partially located in the turnover section 3201, and the isolation sleeve body 3220 is sleeved on the outer side of the binding sleeve 3210. The binding member 3300 is located on the folding segment 3210 and passes through at least a portion of the positioning hole 3211. Here, the term "outwardly folded" means that the folded section 3201 is folded to the outside of the main vessel 1100 (when the isolation sleeve 3200 is sleeved on the distal end of the main vessel 1100), or the folded section 3201 is folded to the outside of the main stent 2100 (when the isolation sleeve 3200 is sleeved on the proximal end of the main stent 2100), the folding direction is shown by an arrow S in fig. 12b, and after folding, on the folded section 3201, the constraining sleeve 3210 is located on the outside of the isolation sleeve body 3220. It should be understood that, for the isolation sleeve 3200, the proximal end thereof refers to the end of the isolation sleeve 3200 close to the heart before the folding end 3201 is folded, and the distal end thereof refers to the end of the isolation sleeve 3200 far from the heart before the folding section 3201 is folded, where the proximal end of the isolation sleeve 3200 is not connected with other structures, that is, the proximal end of the isolation sleeve 3200 is a free end, in order to achieve the purpose that the folding section 3201 is folded outwards. In addition, the distal end of the isolation sleeve body 3220 may be connected to the distal end of the crimp sleeve 3210.

Such a configuration makes the medical system 100 applicable to full-arch trunk surgery. At the time of surgery, the diseased vessel is cut off, and a healthy autologous vessel such as the descending aorta 10 (shown in fig. 12a to 12 d) is left as a target lumen. The proximal end of the main stent 2100 is connected to the distal end of the main vessel 1100 of the artificial blood vessel 1000 and the main vessel 1100 is made to replace the diseased vessel, and the main stent 2100 and the first bare stent 3100 are placed in the target lumen. Then, the folded section 3201 is folded to cover the proximal outer peripheral surface of the target lumen (i.e., the descending aorta 10), so that the isolation sleeve 3200 wraps the proximal end of the target lumen (i.e., the proximal incision of the descending aorta 10), and at the same time, the folded section 3201 is at least partially overlapped with the first bare support 3100 in the axial direction. Since the part of the constraining sheath 3210 located at the folded-back section 3201 is located outside the isolating sheath body 3220 after folding, the radial dimension of the constraining sheath 3210 at the constraining element 3300 can be reduced by tightening the constraining element 3300, and thus the part of the isolating sheath body 3220 located at the folded-back section 3201 can be tightly bound on the proximal outer circumferential surface of the target lumen. Moreover, the target lumen is supported by the first bare support 3100, and the folded section 3201 of the isolation sleeve 3200 is further supported, so that when the binding member 3300 is tightened, the first bare support 3100 can provide a strong radial supporting force, the target lumen is not pressed, the isolation sleeve body 3220 can be tightly attached to the outer wall of the target lumen, the probability of blood leakage at the proximal end of the target lumen is reduced, and the hemostatic effect is improved. By such an operation, the operator does not need to suture the main stent 2100 and the target lumen when performing the full-arch trunk operation, thereby shortening the suturing time, further shortening the deep hypothermia and circulatory arrest time, and reducing the damage to the patient caused by ischemia and hypoxia. Furthermore, in an alternative implementation, the folded-over section 3201 may also be pre-folded before the operation, such that there is an annular gap between the folded-over section 3201 and the main stent 2100 (when the first bare stent 3100 is connected to the main stent 2100) or between the folded-over section 3201 and the main vessel (when the first bare stent 3100 is connected to the main vessel 1100), so that the portion of the isolation sleeve body 3220 located at the folded-over section 3201 can be tightly bound to the proximal outer peripheral surface of the target lumen by inserting the proximal end of the native vessel into the annular gap and then tightening the binding member 3300 during the operation. The distal end of the main vessel 1100 and the proximal end of the main stent 2100 may be pre-attached prior to surgery, for example by suturing, thereby further reducing the number of attachment steps and the time required for surgery. It should be understood that the radial dimensions of the proximal end of the main stent 2100 and the distal end of the main vessel 1100 are configured as the case may be, so long as the proximal end of the main stent 2100 and the distal end of the main vessel 1100 do not create a plication when sutured. After the distal end of the main vessel 1100 is connected to the proximal end of the main stent 2100, the folded sections 3201 are located outside the main vessel 1100. In addition, the proximal inner diameter of the main stent 2100 and the distal inner diameter of the main vessel 1100 may be determined according to the actual anatomical size of the vessel, and are typically 20mm to 34 mm.

In the embodiment of the present invention, the specific arrangement positions of the first bare stent 3100 and the spacer 3200 may be selected in various ways. For example, in one implementation, as shown in fig. 1 and 2, the first bare stent 3100 is disposed at a proximal end of the main stent 2100, and a distal end of the spacer 3200 is sleeved on the proximal end of the main stent 2100. Here, the distal end of the spacer sleeve 3200 may extend into the lumen of the main stent 2100, such that the distal end of the spacer sleeve 3200 is coupled to the proximal inner surface of the main stent 2100, or the distal end of the spacer sleeve 3200 is coupled to the proximal outer surface of the main stent 2100. In another implementation, the first bare stent 3100 is disposed at a proximal end of the main stent 2100, and a distal end of the spacer sleeve is sleeved on a distal outer peripheral surface of the main vessel (not shown). In yet another implementation, as shown in fig. 3, the first bare stent 3100 is disposed at the distal end of the main vessel 1100, and the distal end of the isolation sleeve 3200 is sleeved on the outer peripheral surface of the distal end of the main vessel 1100.

Further preferably, said first bare stent 3100 is disposed at a proximal inner surface of said main stent 2100 (when said first bare stent 3100 is disposed at a proximal end of said main stent 2100) or at a distal inner surface of said main vessel 1100 (when said first bare stent 3100 is disposed at a distal end of said main vessel 1100). This has the advantage that when the first bare stent 3100 is implanted in the target lumen, the first bare stent 3100 does not directly contact the lumen wall of the target lumen, reducing foreign body irritation to the lumen wall of the target lumen.

Next, the components of the medical system 100 will be further described in detail by taking the first bare stent 3100 disposed at the proximal end of the main stent 2100, and the distal end of the isolation sleeve 3200 sleeved on the proximal end of the main stent 2100. It should be understood that the following description may be modified by those skilled in the art to adapt to the situation where the first bare stent 3100 is disposed at the distal end of the main vessel 1100 and the spacer 3200 is sleeved on the outer surface of the distal end of the main vessel 1100, or to adapt to the situation where the first bare stent 3100 is disposed at the proximal end of the main vessel 2100 and the spacer 3200 is sleeved on the outer peripheral surface of the distal end of the main vessel 1100.

Referring to fig. 1 to 4, the artificial blood vessel 1000 may be a three-branch artificial blood vessel, that is, the artificial blood vessel 1000 further includes a first branch blood vessel 1200, a second branch blood vessel 1300 and a third branch blood vessel 1400.

Optionally, as shown in fig. 1 to fig. 3, three windows (not labeled in the figures) are opened on the side wall of the main blood vessel 1100, which are respectively a first window (not labeled in the figures), a second window (not labeled in the figures), and a third window (not labeled in the figures). The proximal end of the first branch vessel 1200 is connected at the first window such that the lumen of the first branch vessel 1200 is in communication with the lumen of the main vessel 1100. The proximal end of the second branch vessel 1300 is connected to the second window such that the lumen of the second branch vessel 1300 communicates with the lumen of the main vessel 1100. The proximal end of the third branch vessel 1400 is connected to the third window such that the lumen of the third branch vessel 1400 is in communication with the main vessel 1100.

Optionally, the first window and the second window are located on the same side of the main vessel 1100 and are spaced apart in the axial direction of the main vessel 1100, for example, the first window is located on the proximal side of the second window. This is done to facilitate anastomosis of the distal end of the first branch vessel 1200 with the brachiocephalic trunk artery 40 (as labelled in figure 12 d), thereby allowing blood to flow from the main vessel 1100 into the first branch vessel 1200 through the first window and into the brachiocephalic trunk artery 40; and facilitating anastomosis of the distal end of the second branch vessel 1300 to the left common carotid artery 50 (as referenced in fig. 12 d) to enable blood flow from the main vessel 1100 through the second window into the second branch vessel 1300 and into the left common carotid artery 50. The purpose of the third branch 1400 is to be connected to an extracorporeal circulation device (e.g., arterial pump) to perform extracorporeal circulation during surgery to restore blood perfusion in the lower body of the patient.

Alternatively, referring to fig. 4, two windows, namely a fourth window (not shown) and a fifth window (not shown), are opened on the side wall of the main vessel 1100. The proximal end of the first branch vessel 1200 is connected to the fourth window, a sixth window is opened on the sidewall of the first branch vessel 1200, the sixth window is located on the side of the sidewall of the first branch vessel 1200 near the distal end as viewed in the circumferential direction of the first branch vessel 1200, and the second window is located at the end of the sidewall of the first branch vessel near the main vessel 1100 as viewed in the axial direction of the first branch vessel 1200. The proximal end of the second branch vessel 1300 is connected to the sixth window. The proximal end of the third branch 1400 is connected to the fifth window.

Compared with a four-branch artificial blood vessel commonly used in the prior art (namely, the artificial blood vessel comprises four branch blood vessels, wherein three branch blood vessels are respectively used for suturing three branch arteries, and the other branch blood vessel is used for extracorporeal circulation), the three-branch artificial blood vessel used in the embodiment of the invention only needs to enable two branch blood vessels to be anastomosed with the corresponding branch arteries (namely, the first branch blood vessel 1200 is anastomosed with the brachiocephalic trunk artery 40, and the second branch blood vessel 1300 is anastomosed with the left common carotid artery 50), so that anastomotic positions are reduced, time required by anastomosis operation is shortened, and further operation time can be shortened.

Preferably, at least one of the main vessel 1100, the first branch vessel 1200, the second branch vessel 1300, and the third branch vessel 1400 is a bellows structure. The corrugated structure has good flexibility, and the bending angle can be larger than 90 degrees, which is beneficial to enabling the first branch blood vessel 1200 to be successfully anastomosed with the brachiocephalic trunk artery 40 and the second branch blood vessel 1300 to be successfully anastomosed with the left common carotid artery 50.

The main vessel 1100 may have an axial length greater than 200mm, specifically tailored to the actual requirements. The inner diameter of the first branch vessel 1200 is 10mm or 12mm, the inner diameter of the second branch vessel 1300 is 8mm, and the inner diameter of the third branch vessel 1400 is 10 mm. The axial lengths of the three branch blood vessels can be larger than 100mm, and the three branch blood vessels are cut according to actual requirements.

In addition, the embodiment of the present invention does not particularly limit the material of the artificial blood vessel 1000, as long as it has good sealing property. Alternative materials include, but are not limited to, at least one of polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), Thermoplastic Polyurethane (TPU). In one non-limiting embodiment, each of the portions of the vascular prosthesis includes an inner layer, an intermediate layer and an outer layer, that is, each of the main vessel 1100, the first branch vessel 1200, the second branch vessel 1300 and the third branch vessel 1400 may include an inner layer, an intermediate layer and an outer layer, wherein the inner layer and the outer layer may be made of polyethylene terephthalate, and the intermediate layer may be made of thermoplastic polyurethane. Further, the artificial blood vessel 1000 may further include a coating layer coated on the outer layer, and the coating layer is made of a material including, but not limited to, a protein, such as at least one of collagen, gelatin, and albumin.

In match with the artificial blood vessel 1000, a seventh window (not labeled) is opened on the sidewall of the main stent 2100, and the stent graft 2000 further includes a branch stent 2200, and the proximal end of the branch stent 2200 is connected to the seventh window, so that the inner cavity of the branch stent 2200 communicates with the inner cavity of the main stent 2100. The distal end of the branch stent 2200 is used for being directly inserted into the left subclavian artery, so that the deep dissociation and anastomosis of the left subclavian artery are effectively avoided, and the operation is obviously simplified. Meanwhile, the configuration enables the stent graft 2000 to match only one branch artery, and does not need to consider the problem of aligning each branch stent with the corresponding branch artery when the stent graft 2000 comprises a plurality of branch stents to match the plurality of branch arteries, so that the stent graft has better universal applicability.

It will be appreciated by those skilled in the art that in other implementations, the artificial blood vessel may be a four-branch artificial blood vessel in the prior art, and accordingly, the stent graft includes only a main stent (not shown in the figure). Alternatively, the artificial blood vessel may be two branch vessels (i.e., the artificial blood vessel includes two branch vessels, one branch vessel for anastomosis with the brachiocephalic trunk artery 40 and the other branch vessel for extracorporeal circulation), and the stent graft further includes two branch stents for insertion into the left common carotid artery 50 and the left subclavian artery 20, respectively.

Further, the outer diameter of the main stent 2100 tapers in a proximal to distal direction to more closely match the main stent 2100 to the anatomy of the target lumen. Optionally, the proximal outer diameter of the main stent 2100 is 0-4 mm larger than the distal outer diameter. In addition, the axial length of the main support 2100 can be 80 mm-200 mm. And the inner diameter of the branch blood vessel 2200 is 6 mm-14 mm, and the axial length is 20 mm-40 mm.

In this embodiment, the main stent 2100 includes a second bare stent 2110 and a coating film, which may be referred to as a first coating film 2120, the first coating film 2120 is coated on a circumferential surface of the second bare stent 2110, and the seventh window is opened on the first coating film 2120. The stent 2200 includes a third bare stent 2210 and a coating film, referred to as a second coating film 2220, coated on the circumferential surface of the third bare stent 2210 with the second coating film 2220. The second bare stent 2110 and the third bare stent 2210 may each include a plurality of wavy coils sequentially arranged along the corresponding axial direction, and each wavy coil may have a constant wave height or a varying wave height, or the second bare stent 2110 and the third bare stent 2210 may be helical structures spirally wound around the corresponding axis, and each helical coil of the helical structures is wavy, which is not limited by the embodiment of the invention. The second bare stent 2110 and the third bare stent 2210 are made of materials including but not limited to nitinol and stainless steel. The materials of the first and second coatings 2120 and 2220 include, but are not limited to, polyethylene terephthalate, polytetrafluoroethylene, and expanded polytetrafluoroethylene.

Further, when the first bare stent 3100 is disposed at the proximal end of the main stent 2100 and the spacer sleeve 3200 is sleeved on the proximal end of the main stent 2100, it is preferable that the proximal end of the first bare stent 3100 is flush with the proximal end of the main stent 2100, so that the spacer sleeve 3200 is at least partially located at the proximal side of the main stent 2100, and the portion of the spacer sleeve 3200 located at the proximal side of the main stent 2100 constitutes the folded-over section 3201.

Further, the proximal end of the first cover 2120 extends beyond the proximal end of the second bare stent 2110, so that the proximal end of the first cover 2120 is the proximal end of the main stent 2100, and the first bare stent 3100 is disposed on the portion of the first cover 2120 that extends beyond the second bare stent 2110. The first bare bracket 3100 may be cut from a metal tube. As shown in fig. 5, a plurality of aperture structures 3110 are formed on the first bare stent 3100 by cutting, and each aperture structure 3110 may be prismatic, which is advantageous in that the metal coverage of the first bare stent 3100 is low, and when the first bare stent 3100 is placed in the target lumen, foreign body irritation to the wall of the target lumen is relatively small, which is beneficial to tissue endothelialization. The axial length of the first bare stent 3100 is 10mm to 15mm, and it is understood that when the first bare stent 3100 is disposed on the inner surface of the main stent 2100, the outer diameter of the first bare stent 3100 is equivalent to the proximal inner diameter of the main stent 2100, in particular, the proximal inner diameter of the first cover 2120. It is also understood that when the first bare stent 3100 is disposed on an inner surface of the main vessel 1100, the outer diameter of the first bare stent 3100 corresponds to the distal inner diameter of the main vessel 1100.

From the viewpoint of easy folding, in the embodiment, the radial dimensions of the constraining sheath 3210 and the isolating sheath body 3220 are gradually reduced from the proximal end to the distal end, so that the overall isolating sheath 3200 has a tapered structure (as shown in fig. 6 and 7). The axial length L of isolation sleeve 3200 is according to first naked support 3100's length setting, the radial dimension D of isolation sleeve 3200's distal end sets up according to actual conditions, as long as it can cup joint the near-end of main support 2100, and can not form the fold can. The angle of an included angle alpha formed between the side wall of the isolation sleeve 3200 and the axis of the isolation sleeve 3200 is 0-90 degrees. It should be understood that, when the isolation sleeve 3200 is sleeved on the outer peripheral surface of the distal end of the main blood vessel 1100, the distal end of the isolation sleeve 3200 is connected with the main blood vessel 1100, and the radial dimension D of the distal end of the isolation sleeve 3200 is set according to the radial dimension of the distal end of the main blood vessel 1100, so that the isolation sleeve 3200 does not form a fold.

The specific form of the positioning hole 3211 on the binding sleeve 3210 is determined according to the structure of the binding member 3300. For example, referring to fig. 8 and 9, in an alternative implementation, the constraining member 3300 includes an elongated strip-shaped structure (as shown in fig. 2), the positioning hole 3211 is an elongated hole extending along an axial direction of the constraining sheath 3210, an axial dimension L1 of the positioning hole 3211 is greater than or equal to a width of the elongated strip-shaped structure, and a circumferential dimension w of the positioning hole 3211 is greater than or equal to a thickness of the elongated strip-shaped structure. Here, the positioning hole 3211 extends in the axial direction of the constraining sheath 3210, which does not mean that the positioning hole 3211 is parallel to the axis of the constraining sheath 3210, but means that the positioning hole 3211 has a proximal end and a distal end opposite to each other in the axial direction of the constraining sheath 3210, the axial dimension of the positioning hole 3211 is the distance between the proximal end and the distal end of the positioning hole 3211, and the circumferential dimension of the positioning hole 3211 is the dimension of the positioning hole 3211 in the circumferential direction of the constraining sheath 3210. Alternatively, referring to fig. 10 and 11, in another alternative implementation manner, the constraining member 3300 includes a constraining line, each positioning hole 3211 includes a plurality of sub-positioning holes 3211a, the plurality of sub-positioning holes 3211a are arranged at intervals in a proximal-to-distal direction, and an aperture p of the sub-positioning holes 3211a is greater than or equal to an outer diameter of the constraining line.

The material of the binding member 3300 may be various polymer materials, including but not limited to at least one of polyethylene terephthalate (pet) or Polyurethane (PU). The material of the spacer body 3220 may be the same as that of the artificial blood vessel 1000, for example, the spacer body 3220 includes an inner layer, an intermediate layer and an outer layer, the inner layer and the outer layer are made of polyethylene terephthalate, and the intermediate layer is made of thermoplastic polyurethane, so that the spacer body 3220 has good sealing property, and the possibility of blood leakage at the proximal end of the target lumen is reduced. The material of the binding sleeve 3210 may also be the same as that of the isolation sleeve body 3220.

Fig. 12a to 12d show the medical system 100 applied to a full-arch trunk operation. In the figure, the aortic arch is affected by pathological changes, three windows (i.e., the first window, the second window and the third window are formed on the sidewall of the main vessel 1100) are formed on the sidewall of the main vessel 1100, the proximal ends of the three branch vessels are respectively connected to the three windows, and the distal end of the main vessel 1100 is connected to the proximal end of the main stent 2100 before the operation.

The operation process is as follows: first, the brachiocephalic trunk 40 and the left common carotid artery 50 are blocked, while selective cerebral perfusion is performed through the right axillary artery, the aortic arch is dissected, and the brachiocephalic trunk 40 and the left common carotid artery 50 are transected, respectively. Next, the morphology of the proximal end of the native vessel (i.e., the target lumen, which in this embodiment is the descending aorta 10) is prepared. Thereafter, the main stent 2100 of the medical system 100 is placed into the descending aorta 10 such that the first bare stent 3100 is placed into the descending aorta 10 along with the main stent 2100, and the branch stent 2200 is inserted into the left subclavian artery 20 (as shown in fig. 12 a). Next, as shown in fig. 12b, the folded-over section 3201 of the isolation sleeve 3200 is folded outwards in the direction of arrow S, so that the folded-over section 3201 covers the proximal outer surface of the descending aorta 10 and wraps the proximal end of the descending aorta 10. At this time, in the turning section 3201, the isolation sleeve body (not shown in fig. 12 b) is in contact with the outer wall of the descending aorta 10, the constraining sleeve 3210 covers the isolation sleeve body, and the constraining sleeve 3210 is exposed in the surgical field, so as to facilitate subsequent tightening of the constraining member 3300, and at this time, the isolation sleeve 3200 axially overlaps at least partially with the first bare stent 3100, so as to facilitate tightening of the constraining member 3300, and provide support for the isolation sleeve 3200. Then, the isolation sleeve 3200 is simply sutured to the descending aorta 10, preferably with sutures, to prevent axial play between the isolation sleeve 3200 and the descending aorta 10. Next, the binder 3300 is tightened to tighten the folded section 3201 of the isolation sleeve 3200 around the outer peripheral surface of the proximal end of the descending aorta 10 (as shown in fig. 12 c). An extracorporeal circulation device (typically an arterial pump) is then connected to the third branch 1400 and extracorporeal circulation is performed to restore blood supply to the lower body of the patient. Next, the distal end of the second branch vessel 1300 is anastomosed to the left common carotid artery 50, and the distal end of the first branch vessel 1200 is anastomosed to the brachiocephalic artery 40. Thereafter, the brachiocephalic trunk 40 and the left common carotid artery 50 are exsufflated and allowed to re-warm, the proximal end of the main vessel 1100 is anastomosed to the distal end of the ascending aorta 30, and finally the third branch vessel 1400 is ligated and the heart cycle is restored (see fig. 12 d).

Furthermore, it should be noted that main stent 2100 and branch stent 2200 may be constrained in any suitable manner during introduction of medical system 100 into a patient to reduce the radial dimensions of main stent 1100 and branch stent 2200.

Further, an auxiliary device is also provided in the embodiments of the present invention, and the auxiliary device is the aforementioned auxiliary device 3000.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (16)

1. A medical system, comprising:

artificial blood vessels, including major blood vessels;

the covered stent comprises a main stent, wherein the proximal end of the main stent is used for being connected with the distal end of the main blood vessel; and (c) a second step of,

the auxiliary device comprises a first bare stent, an isolation sleeve and a binding piece; the first bare stent is disposed on a distal circumferential face of the main vessel or a proximal circumferential face of the main stent; the isolation sleeve is sleeved at the far end of the main blood vessel or the near end of the main support and comprises a turnover section, the turnover section is used for being turned outwards, the turnover section is located on the near end side of the first naked support before the turnover section is turned over, and after the turnover section is turned over, the turnover section and the first naked support are at least partially overlapped in the axial direction; the isolation sleeve comprises a binding sleeve body and an isolation sleeve body, a plurality of positioning holes are formed in the binding sleeve body at intervals along the circumferential direction, at least part of the positioning holes are located on the turning sections, and the isolation sleeve body is sleeved on the outer side of the binding sleeve body; the binding piece is located on the turnover section and penetrates through at least part of the positioning holes.

2. The medical system of claim 1, wherein said main stent and said first bare stent are for insertion into a target lumen; the medical system is configured to: when the first bare stent is inserted into the target lumen and the turning section turns outwards, the turning section covers the outer peripheral surface of the near end of the target lumen, and the binding piece is used for tightening so that the radial size of the turning section at the position of the binding piece is reduced and tightly hooped on the outer peripheral surface of the near end of the target lumen.

3. The medical system according to claim 1 or 2, wherein the first bare stent is disposed at the distal end of the main vessel, and the isolation sleeve is sleeved on the outer peripheral surface of the distal end of the main vessel; or the first bare stent is arranged at the proximal end of the main stent, and the isolation sleeve is sleeved at the proximal end of the main stent; or the first bare stent is arranged at the near end of the main stent, and the isolation sleeve is sleeved on the outer peripheral surface of the far end of the main blood vessel.

4. The medical system of claim 3, wherein when the first bare stent is disposed at the proximal end of the main stent with the isolation sleeve nested at the proximal end of the main stent, the proximal end of the first bare stent is flush with the proximal end of the main stent.

5. The medical system of claim 1, wherein the primary stent comprises a second bare stent and a cover; when the first bare stent is arranged at the proximal end of the main stent, the proximal end of the covering membrane exceeds the proximal end of the second bare stent, and the first bare stent is arranged on the part of the covering membrane exceeding the second bare stent.

6. The medical system of claim 1, wherein the distal end of the main vessel is connected to the proximal end of the main stent, and the folded section is fitted over the outer peripheral surface of the distal end of the main vessel.

7. The medical system of claim 1, wherein the radial dimension of the retaining cuff and the radial dimension of the isolation cuff body each taper in a proximal to distal direction.

8. The medical system of claim 1, wherein the restraining element comprises an elongated strap-like structure, the positioning aperture is an elongated aperture extending in an axial direction of the restraining sheath, the positioning aperture has an axial dimension greater than or equal to a width of the restraining element, and the positioning aperture has a circumferential dimension greater than or equal to a thickness of the restraining element.

9. The medical system according to claim 1, wherein the tether includes a leash line, each of the positioning holes includes a plurality of sub-positioning holes spaced apart in a proximal to distal direction, the sub-positioning holes having a bore diameter greater than or equal to an outer diameter of the leash line.

10. The medical system of claim 1, wherein the first bare stent is a cutting stent.

11. The medical system of claim 1, wherein the side wall of the main vessel defines a first window, a second window, and a third window; the artificial blood vessel further comprises a first branch blood vessel, a second branch blood vessel and a third branch blood vessel; the proximal end of the first branch blood vessel is connected to the first window, the proximal end of the second branch blood vessel is connected to the second window, and the proximal end of the third branch blood vessel is connected to the third window.

12. The medical system of claim 1, wherein a fourth window and a fifth window are opened on the side wall of the main vessel, and the artificial vessel further comprises a first branch vessel, a second branch vessel and a third branch vessel; the proximal end of the first branch blood vessel is connected to the fourth window, a sixth window is formed in the side wall of the first branch blood vessel, the proximal end of the second branch blood vessel is connected to the sixth window, and the third branch blood vessel is connected to the fifth window.

13. The medical system of claim 11 or 12, wherein a seventh window is defined in a sidewall of the main stent, and wherein the stent graft further comprises a branch stent, and a proximal end of the branch stent is connected to the seventh window.

14. The medical system of claim 11 or 12, wherein at least one of the main vessel, the first branch vessel, the second branch vessel, and the third branch vessel is a bellows structure.

15. The medical system of claim 1, wherein an outer diameter of said main stent tapers in a proximal to distal direction.

16. An auxiliary device is characterized by comprising a first bare stent, an isolation sleeve and a binding piece; the first naked stent is used for being arranged at the far end of a main vessel of an artificial blood vessel or at the near end of a main stent of a covered stent; the separation sleeve is used for being sleeved at the far end of the main blood vessel or the near end of the main support, the separation sleeve comprises a turnover section, the turnover section is used for being turned outwards, the turnover section is located on the near end side of the first naked support before the turnover section is turned over, the turnover section is at least partially overlapped with the first naked support in the axial direction after the turnover section is turned over, the separation sleeve comprises a binding sleeve and a separation sleeve body, a plurality of positioning holes which are circumferentially arranged at intervals are formed in the binding sleeve, the positioning holes are at least partially located in the turnover section, and the separation sleeve body is sleeved on the outer side of the binding sleeve; the binding piece is arranged on the turnover section and penetrates through at least part of the positioning hole.

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