CN-121987394-A - Shunt balloon device for blood flow maintenance and aortic tectorial stent system

CN121987394ACN 121987394 ACN121987394 ACN 121987394ACN-121987394-A

Abstract

The invention discloses a shunt saccule device for blood flow maintenance and an aortic tectorial membrane stent system, and relates to the technical field of interventional medical instruments. The shunt balloon device adopts a peripheral constraint type expandable balloon and comprises a cylindrical balloon, a conveying pipe and a balloon supporting component, wherein the cylindrical balloon forms a hollow catheter with two ends penetrating and side walls sealing in an expanded state, the conveying pipe is used for placing the cylindrical balloon in an aorta and a branch artery, a distal opening of the balloon is positioned in the aorta, a proximal opening of the balloon is positioned in the branch artery, blood automatically flows into the branch artery from the aorta through the hollow catheter of the balloon to form a blood flow channel, and the balloon supporting component is used for installing the cylindrical balloon at the distal end of the conveying pipe, expanding and contracting synchronously with the cylindrical balloon and restraining and fixing the cylindrical balloon so as to prevent the cylindrical balloon from falling off. The invention can form a stable and reliable blood flow channel outside the covered stent and has the advantages of reliable effect, easy control, convenient operation and strong applicability.

Inventors

Dou ning
BAO XIANHAO
Pei Diefei
LI XIAOGUANG
TAN JINGJING
ZHANG HENG
BI SHIYUAN
ZHANG LEI
MEN YULONG
ZHANG TING

Assignees

上海市第四人民医院(同济大学附属上海市第四人民医院)

Dates

Publication Date: 20260508
Application Date: 20260320

Claims (10)

1. A shunt balloon apparatus for blood flow maintenance for forming a temporary flow guide channel on the outside of an aortic stent graft for conducting aortic blood flow to a branch artery to maintain blood perfusion of the branch artery, comprising: the tubular saccule is provided with an expansion state and a contraction state, and a hollow catheter with two through ends and sealed side walls is formed in the expansion state; The device comprises a main artery, a tubular balloon, a conveying pipe, a tubular balloon and a tubular stent, wherein the tubular balloon is placed in the main artery and the branch artery, a distal opening of the tubular balloon is positioned in the main artery, a proximal opening of the tubular balloon is positioned in the branch artery, blood automatically flows into the branch artery from the main artery through a hollow catheter of the tubular balloon to form a blood flow channel, and the tubular balloon is withdrawn after the main artery stent is completely fenestrated; the balloon support assembly is used for installing the cylindrical balloon at the distal end of the conveying pipe, expanding and contracting synchronously with the cylindrical balloon and restraining and fixing the cylindrical balloon so as to prevent the cylindrical balloon from falling off.
2. The shunt balloon apparatus according to claim 1, wherein a medium chamber for containing filling medium is provided inside a side wall of the cylindrical balloon, and the cylindrical balloon is put into an expanded state or a contracted state by infusing or extracting the filling medium into the medium chamber through a medium infusion line extending from a delivery tube; The catheter comprises a catheter body, a catheter seat, a tubular balloon and a balloon supporting component, wherein the catheter body is provided with a hollow cavity, a guide wire cavity and a balloon filling cavity are arranged in the catheter body, the proximal end of the catheter body is used for being connected with the catheter seat, the catheter seat at least comprises three ports, one port is connected with the proximal end of the catheter body, one port is used for filling and emptying the balloon, one port is used for using a guide wire, the distal end of the catheter body is telescopically arranged in the delivery sheath, and the tubular balloon and the balloon supporting component can be installed in the delivery sheath in a contracted state.
3. The shunt balloon apparatus according to claim 2, wherein said tubular balloon is of a multi-chamber structure comprising a plurality of individual chambers of a flat annular balloon unit connected in series in an axial direction to form an integral balloon body, thereby forming said tubular balloon; An independent medium infusion pipeline is arranged corresponding to each flat annular bag unit so as to independently control the expansion and contraction of each flat annular bag unit.
4. The shunt balloon apparatus according to claim 2, wherein the delivery sheath is an 8F arterial sheath when forming temporary flow channels for aortic arch and upper brachiocephalic trunk branches, and wherein the diameter of the inner wall of the hollow catheter of the tubular balloon is 3mm or more, and can provide a blood shunt of at least 150ml/min to meet the brain blood supply requirement.
5. The shunt balloon apparatus according to any one of claims 2-4, wherein the balloon support assembly is disposed at a distal end of the delivery tube, comprising an expandable support mesh mounted outside of the cylindrical balloon, the expandable support mesh expanding and contracting in synchronization with the cylindrical balloon; after delivery sheath is delivered to the vicinity of the target site by vascular puncture, the cylindrical balloon and expandable support mesh are advanced to the target site for placement by pushing the delivery catheter in a distal direction.
6. The shunt balloon apparatus according to claim 5 wherein the expandable support mesh comprises a main body section and a proximal connecting section, wherein the main body section is wrapped around the circumference of the tubular balloon to form a wrapped mesh and the length of the main body section is adapted to the length of the tubular balloon; When the expandable support net is in an expanded state, the main body section is in a cylinder shape matched with the cylinder-shaped balloon, and the proximal connecting section is gradually enlarged from the proximal end to the distal end to form an umbrella shape.
7. The shunt balloon apparatus according to claim 5 wherein the expandable support mesh comprises a main body section, a proximal connecting section and a distal connecting section, wherein the main body section is wrapped around the circumference of the tubular balloon to form a wrapped mesh and the length of the main body section is adapted to the length of the tubular balloon, wherein the proximal connecting section is positioned at the proximal end of the main body section and connected to the delivery tube to form a proximal containment structure between the delivery tube and the main body section, wherein the distal connecting section is positioned at the distal end of the main body section to form a distal containment structure, and wherein the distal connecting section is distally provided with a flexible head end; When the expandable support net is in an expanded state, the main body section is in a cylinder shape matched with the cylinder-shaped balloon, the proximal end connecting section is gradually increased from the proximal end to the distal end to form a first umbrella shape, and the distal end connecting section is gradually reduced from the proximal end to the distal end to form a second umbrella shape, so that the expandable support net forms a spindle shape.
8. The shunt balloon apparatus according to claim 5 or 6 wherein the expandable support mesh is of wire skeleton construction and the main section support mesh is snugly fitted around the circumference of the tubular balloon; The proximal and distal holding structures are holding nets, holding wires or holding bars, and when the holding wires or holding bars are adopted, the holding wires or holding bars comprise a plurality of symmetrically arranged supporting wires or supporting rods; the cylindrical balloon is provided with a plurality of development rings formed by forging and pressing, and the development rings are used for marking the length of the cylindrical balloon.
9. An aortic stent graft system comprising an aortic stent graft, a stent delivery device, a rupture device and a shunt balloon apparatus according to any one of claims 1-8, in combination; The delivery tube of the shunt balloon device is used for pushing the cylindrical balloon into the aorta and the branch artery in the delivery sheath, and the cylindrical balloon is infused with a medium from a contracted state to an expanded state after being pushed out from the distal opening of the delivery sheath; The stent conveying device is used for conveying the aortic tectorial membrane stent into the aorta, the cylindrical balloon in the expanded state is positioned at one side of the aortic tectorial membrane stent, and the cylindrical balloon is supported between the vessel wall and the aortic tectorial membrane stent to form a blood flow channel at the outer side of the stent so as to conduct the aortic blood flow with the branch arteries; The rupture membrane apparatus is used for windowing a position to be windowed of the aortic tectorial membrane on the aortic tectorial membrane bracket; after the aortic tectorial stent completes windowing, the tubular saccule is controlled to discharge medium to be in a contracted state, the tubular saccule in the contracted state is retracted to the delivery sheath through the delivery pipe, and then the vessel is withdrawn through the delivery sheath.
10. The aortic stent system as claimed in claim 9, further comprising a modular branched stent graft, the aortic stent graft being used in combination with a branched stent graft, the branched stent graft being attached to a fenestration on the greater curvature side of the aortic stent graft.

Description

Shunt balloon device for blood flow maintenance and aortic tectorial stent system Technical Field The invention relates to the technical field of interventional medical instruments, in particular to a shunt saccule device for maintaining blood flow and an aortic tectorial membrane stent system. Background Aortic diseases are common diseases in the cardiovascular disease spectrum, the incidence rate is rapidly increased, such as aortic aneurysm, atherosclerosis, aortic dissection, aortic ulcer and the like, and the diseases are greatly harmful to human health and even endanger life. The aortic arch is a portion of the aorta and is the critical structure connecting the ascending and descending aorta in an "arch" shape. Above the aortic arch, 3 major branches are given, respectively, the brachiocephalic trunk (innominate artery), the left common carotid artery, and the left subclavian artery, as shown in fig. 1. The aortic arch has a complex bending structure and must retain the branch vessels of the head and arm, and the main clinical difficulty is how to keep the aortic arch lesions isolated and keep the branch vessels on the arch unobstructed. Along with the gradual breakthrough of the restriction of anatomical conditions in the endoluminal treatment technique, the complete endoluminal repair technique is increasingly widely applied to reconstructing the upper branch of the aortic arch, and becomes a true alternative method for treating the aortic arch diseases. The aortic arch intracavity repair has the advantages of small risk, small wound, quick recovery, simplified operation flow and the like by implanting a bracket into a blood vessel to reconstruct the blood vessel and branches so as to ensure blood circulation, and the parallel bracket, the fenestration bracket, the branch bracket and the like are derived at the arch part according to individual differences of cases. The windowing technology is divided into pre-windowing (or external windowing) and in-situ windowing (or in-vivo in-situ windowing). The pre-windowing is to measure the size and the position of the aortic arch branch firstly, then design windowing in vitro, and keep branch blood supply, the technology needs individual customization, and the risk of occurrence of internal leakage of the stent is large, so that the situation that the opening of the branch artery is changed after the main body stent is released in the operation is difficult to deal with. The in-situ windowing is to release the aortic tectorial membrane stent to cover the branch vessel, then use windowing device (such as needle, laser, radio frequency catheter, etc.) to assist in-situ windowing the aortic tectorial membrane stent at the opening of the branch vessel, then implant the proper branch tectorial membrane stent, and ensure the blood perfusion of the aorta and the visceral vessel. In-situ windowing in vivo is an ideal visceral artery reconstruction technology at present. Although in situ windowing has many advantages and is suitable for total reconstruction across the arch, in situ windowing has the problem of isolating the time of visceral branch arteries and possibly causing visceral ischemia injury under the condition of difficult windowing. In particular, in total arch-crossing reconstructions, because the aortic stent graft is released in the thoracic aortic arch, the stent graft will block the branch vessels on the arch, which will cause interruption of cerebral blood flow before the fenestration reconstruction is completed, and the graft will block the branch on the arch and cause intracranial ischemia, resulting in irreversible damage (5 minutes of interruption of cerebral blood flow will result in loss of consciousness of the human body, irreversible damage to the brain and even death of the patient). Currently, in order to ensure cerebral circulation, an extracorporeal circulation or cryogenic stop circulation method is generally adopted to solve the problem that the blood flow of the head is blocked by an aortic stent graft before branch reconstruction. However, both extracorporeal circulation and cryogenic stop circulation techniques have high requirements on hospital conditions and operative levels, and cause problems of high complications. The aortic stent graft can block arterial branch blood flow in the windowing process, which is a technical problem that the in-situ windowing mode cannot be widely popularized and applied. Accordingly, the prior art provides some aortic blood flow maintenance schemes. For example, patent ZL201911403623.2 discloses a vascular reconstruction device, which comprises a covered stent and an expansion piece, wherein the expansion piece can be placed in the covered stent and expanded to be not smaller than the inner diameter of the covered stent, the covered stent comprises a main body consisting of a frame and a covered membrane, the covered stent is used as a treatment stent for treating aortic aneurysm or interlayer, the