Guide magnetic balloon catheter device for branch artery reconstruction

Abstract

The utility model relates to a guiding magnetic balloon catheter device for branch artery reconstruction. A guiding catheter and a magnetizing catheter are fixed side by side; the magnetic balloon is of a double-layer balloon wall structure, an annular cavity is formed between the double layers of balloon walls and filled with magnetic liquid, and a through hole is formed in the center of the balloon. The head of the magnetizing catheter is communicated with the magnetic balloon, and the tail of the magnetizing catheter is connected with the magnetic liquid injection device; the head of the guide catheter is connected with the through hole of the magnetic balloon and is not communicated with the interior of the magnetic balloon; the guide wire penetrates into the guide catheter, and the front end of the guide wire penetrates through the through hole; a marking ring is arranged at the head of the magnetic balloon, and except for the marking ring, the other outer-layer balloon wall is provided with a magnetism isolating layer capable of isolating magnetism; the magnetic balloon head is provided with a balloon head end which is gradually reduced in diameter and is easy to bend under the driving of the guide wire.

Description

Technical Field

[0001] The utility model relates to a guiding magnetic balloon catheter device for branch artery reconstruction, belonging to the technical field of medical equipment. Background Art

[0002] Aortic aneurysm and aortic dissection are common cardiovascular diseases. Rupture of aneurysm causes a greater risk of death and disease burden. With the update of technology and materials, endovascular repair is widely used in aortic reconstruction. However, there are still technical limitations when endovascular repair is applied to complex branch artery reconstruction. The opening position of the aortic branch artery is highly variable. In the diseased state, the aorta is twisted and torn, and it is difficult to determine the opening position of the branch artery during surgery. Endovascular repair requires the use of multiple technologies to reconstruct the blood flow of the visceral artery branches, isolate the aneurysm cavity and avoid visceral ischemia. Currently, parallel stent, branch stent and fenestrated stent repair are widely used.

[0003] 1. Parallel grafting (PG): After the main stent is released, the parallel stent is placed through a reserved guide wire with the proximal end parallel to the main stent and the distal end positioned in the visceral blood vessels to ensure visceral blood supply. It has a high risk of endoleak after surgery and is now rarely used.

[0004] 2. Off-the-shelf branched stent technology (branched endovascular aneurysm repair, BEVAR): The off-the-shelf stent is designed with a bifurcated stent on the main stent, which can simultaneously reconstruct the aorta and branch vessels during surgery. However, the off-the-shelf branched stent is difficult to use in complex aortic branch reconstruction surgery.

[0005] 3. Fenestrated endovascular aneurysm repair (FEVAR):

[0006] 3.1 Customized stents: Customized stents are made by preoperative CT angiography and three-dimensional reconstruction to evaluate the characteristics of the lesion, determine the stent parameters, and customize the stent after the clinician and the engineer reach a consensus. However, customized stents have a long cycle and high price, making them difficult to be widely used.

[0007] 3.2 In vitro fenestration: In vitro fenestration allows the selection of appropriate fenestration sites on the main covered stent under direct in vitro visualization, and alignment with the branch opening during surgery to ensure visceral blood perfusion while avoiding damage to branch vessels caused by in vivo fenestration. However, in vitro fenestration carries a high risk of internal leakage in the stent, and is difficult to cope with changes in the branch artery opening after the main stent is released during surgery.

[0008] 3.3 In situ fenestration in vivo: In situ fenestration in vivo is to open the branch artery opening with a fenestration device (puncture catheter, radiofrequency catheter or laser catheter) after placing the main stent during surgery, and then insert a suitable branch covered stent to ensure blood perfusion of the aorta and visceral vessels. In situ fenestration in vivo is currently an ideal visceral artery reconstruction technology, but it is necessary to find a positioning method to guide the fenestration and protect the visceral vessels.

[0009] Regarding the technical issues of "in situ fenestration in vivo": in situ fenestration has the time of isolating the visceral branch artery, which may cause visceral ischemia and damage when fenestration is difficult. In addition, visceral arteries often vary and twist, and the existing in situ fenestration devices have the risk of damaging visceral blood vessels.

[0010] A Chinese patent document with a publication date of 2022.07.22 and publication number CN114767327A discloses a "magnetic navigation catheter and navigation method for arterial stenting for visceral artery reconstruction". It is a solution for locating the opening of visceral branch arteries by magnetic attraction after the implantation of a covered stent during "in situ fenestration in the body". This application aims to solve the specific technical problems existing in this solution. Utility Model Content

[0011] Based on the prior art CN114767327A, the utility model provides a further optimized branch artery magnetic navigation device for visceral artery reconstruction during arterial stent surgery, which solves the problem of difficulty in accurate positioning of branch artery reconstruction during percutaneous endothelial aortic stent implantation, thereby achieving the purpose of shortening the isolation time of branch vessels and quickly restoring visceral blood supply.

[0012] The utility model adopts the following technical solutions:

[0013] A guided magnetic balloon catheter device for branch artery reconstruction comprises a guiding catheter 9, a magnetized catheter 8, a magnetic balloon 10, a magnetic liquid injection device 12, and a guiding wire 11; the guiding catheter 9 and the magnetized catheter 8 are fixed side by side; the magnetic balloon 10 is a double-layer balloon wall structure, an annular cavity is formed between the double-layer balloon walls, the annular cavity is filled with magnetic liquid, and the balloon center has a through hole; the head of the magnetized catheter 8 is connected to the magnetic balloon 10, and the tail is connected to the magnetic liquid injection device 12; the head of the guiding catheter 9 is connected to the through hole of the magnetic balloon 10 and is not connected to the inside of the magnetic balloon 10; the guiding wire 11 penetrates into the guiding catheter 9, and the front end passes through the through hole; the head of the magnetic balloon 10 is provided with a marking circle 14, and except for the marking circle 14, the remaining outer balloon wall has a magnetic isolation layer that can isolate magnetism; the head of the magnetic balloon 10 has a balloon tip 15 with a gradually decreasing diameter and is easy to bend under the drive of the guiding wire.

[0014] Preferably, the tail end of the guide catheter 9 is connected to an extracorporeal catheter delivery system 13 and can be delivered into the blood vessel cavity by the catheter delivery system 13 .

[0015] Preferably, it also includes a magnetic liquid injection device 12 connected to the tail end of the magnetized catheter 8 , and the expansion and retraction of the magnetic balloon 10 are controlled by the magnetized catheter 8 and the magnetic liquid injection device 12 .

[0016] A method for using a guided magnetic balloon catheter device for branch artery reconstruction, wherein a magnetized catheter 8, a guide catheter 9, a magnetic balloon 10, and a guide wire 11 are collectively referred to as a magnetic balloon adjustable sheath 16; the method comprises the following steps:

[0017] S1. The magnetic balloon adjustable sheath 16 is sent into the aortic cavity along the arterial puncture point. With the help of the guide wire 11, the balloon head 15 of the magnetic balloon 10 is sent along the aorta to the branch artery. The position of the magnetic balloon 10 is adjusted so that the marking circle 14 is tangent to the opening of the branch artery. The magnetic balloon 10 is expanded by the magnetic liquid injection device 12. The guide wire 11 and the balloon head 15 are positioned in the branch artery to position the branch artery while not completely isolating the distal blood supply of the artery, and the rest of the magnetic balloon 10 is closely attached to the aortic wall.

[0018] S2, releasing the main stent graft 17 to the aorta, the marking ring 14 runs outside the stent graft 17, injecting magnetic liquid through the magnetic liquid injection device 12 and further expanding the magnetic balloon 10, so that the magnetic balloon 10 is closely attached to the main stent graft 17, leaving a window space between the aorta and the stent graft 17;

[0019] S3, inserting the adjustable magnetic bending sheath 4 containing the magnetic attraction head 1 into the arterial cavity through percutaneous puncture, so that the adjustable magnetic bending sheath 4 is inserted into the coated stent and reaches the vicinity of the branch artery; during the puncture process, a guide wire is used in the cavity 5 to help the magnetic catheter reach the vicinity of the branch artery;

[0020] S4, adjusting the position and direction of the adjustable bend 2, so that the magnetic attraction head 1 faces the direction of the branch artery opening by rotating;

[0021] S5, the magnetic attraction head 1 is adsorbed by the mutual attraction between the marking circle 14 on the magnetic balloon 10 outside the main covered stent at the opening of the branch artery and the adjustable magnetic bending sheath 4;

[0022] S6, the mutual attraction between the adjustable magnetic bending sheath 4 and the marking ring 14 can indicate the location of the branch artery opening from the aortic stent graft and keep the magnetic attraction head 1 facing the branch artery opening; the laser catheter is sent from the cavity 5, and the laser catheter reaches the branch artery opening in the stent graft 7; the opening of the branch artery is accurately cauterized on the stent graft 17 by the laser catheter;

[0023] S7. After the intravascular treatment is completed, the magnetic liquid is sucked out through the magnetic liquid injection device 12, the magnetic balloon 10 is recovered and loses its magnetism, and is separated from the magnetic attraction head 1, and the magnetic balloon adjustable sheath 14 is withdrawn along the blood vessel cavity.

[0024] The beneficial effects of the utility model are as follows: on the basis of the existing patent CN114767327A, the structure of the branch artery magnetic navigation catheter is improved, and its head is designed as a magnetic balloon, and the head of the magnetic balloon is provided with a marking circle. In addition to the marking circle, the remaining outer balloon wall has a magnetic isolation layer that can isolate magnetism, thereby cleverly forming a circle of parts that can be magnetically adsorbed on the magnetic balloon; at the same time, the head of the magnetic balloon has a balloon head end with a gradually decreasing diameter and easy to bend under the drive of the guide wire, which can cleverly realize the adsorption function with the adjustable magnetic bending sheath, thereby accurately realizing the window positioning of the corresponding part of the coated stent and the branch artery during surgery. Compared with the existing positioning method of CN114767327A, the magnetic liquid is filled in the utility model, which is more conducive to controlling the release and recovery of the balloon and the attraction and separation of the magnetic balloon and the magnetic suction head through the extracorporeal system. At the same time, the positioning of the marking circle is more convenient, the fault tolerance is strong, and the reliability of positioning is significantly improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of an adjustable magnetic bending sheath (same as the prior art).

[0026] Figure 2 It is a schematic diagram of the structure of the end of the adjustable magnetic bending sheath (same as the prior art).

[0027] Figure 3 The utility model is a schematic diagram of a guided magnetic balloon catheter device for branch artery reconstruction. In the figure, the magnetic attraction head and the magnetic balloon attraction positioning form a composite magnetic device.

[0028] Figure 4 yes Figure 3 Physical picture.

[0029] Figure 5 yes Figure 1 The magnetic attraction head and Figure 3 Schematic diagram of the magnetic balloon being adsorbed.

[0030] Figure 6 yes Figure 5 Physical picture.

[0031] Figure 7 It is a schematic diagram of positioning the window portion on the stent graft at the junction of the abdominal aorta and the renal artery by adsorption using a magnetic attraction head and a magnetic balloon in a specific embodiment. DETAILED DESCRIPTION

[0032] The utility model is further described below in conjunction with the accompanying drawings and specific embodiments.

[0033] In order to solve the problem of difficulty in accurately positioning the reconstruction of branch arteries during percutaneous endovascular stent implantation and to achieve the purpose of reducing the isolation time of branch vessels and quickly restoring visceral blood supply, the utility model designs a device that pre-dilates the branch arteries with a magnetic balloon before releasing the main stent, and uses a magnetic catheter to attract and locate the opening of the branch vessels after the main stent is implanted.

[0034] See also Figure 1 , Figure 1 The structure of the adjustable magnetic bending sheath is shown. In the figure, 1. the magnetic attraction area of ​​the adjustable magnetic bending sheath, 2. the bending part, 3. the extension part, 4. the adjustable magnetic bending sheath. This device belongs to the prior art and is described in detail in CN114767327A. In the figure:

[0035] Magnetic attraction head 1: It is a magnetic material, located at the head end of the adjustable magnetic bending sheath 4, and accurately locates the opening of the branch artery by adsorbing the magnetic balloon, and does not adsorb other structures except the magnetic balloon.

[0036] Adjustable bend 2: Modified from an adjustable bend sheath, the bend is made of softer material, and the head is rotated in different directions using an extracorporeal catheter operating device to facilitate the guidance of magnetic attraction.

[0037] Extension 3: The extension of the main catheter is made of a material with a relatively high hardness, and its tail end is connected to the extracorporeal catheter operation device.

[0038] Adjustable magnetic bending sheath 4: The magnetic attraction head 1, the adjustable bending part 2 and the extension part 3 together constitute the adjustable magnetic bending sheath, and the tail of the adjustable magnetic bending sheath is connected to the extracorporeal catheter operation device; in specific application, according to each person's different blood vessel distribution and treatment needs, any catheter structure such as single bend tube, double hook, hunter head, special-shaped tube, Simon wire series, pigtail tube, cobra tube, etc. can be selected to meet the needs of different occasions.

[0039] See also Figure 2 , Figure 2 This is a schematic diagram of the structure of the end of the adjustable magnetic bending sheath, which is also described in detail in CN114767327A.

[0040] Cavity 5: The cavity inside the magnetic device 5 of the main magnetic catheter, through which intravascular treatment instruments can be run; before and after the adjustable magnetic bending sheath and the magnetic balloon are positioned and adsorbed and fixed, the sheath can be guided by a guide wire, and the laser optical fiber can be used to open windows and guide wires in situ. At the same time, intravascular treatment instruments such as thrombus aspiration catheters and branch vessel stents can be run through the cavity, so as to carry out intravascular treatment at the accurate location of the branch vessel.

[0041] Guide wire 6: runs through cavity 5 to guide the adjustable curved sheath into the aortic cavity.

[0042] The laser catheter 7 travels in the cavity 5 , and after the magnetic attraction head and the magnetic balloon 10 attract and position, it emits laser to open a window in situ on the main coated stent 15 .

[0043] Inner protective layer 8: a protective layer on the inner side of the annular electromagnet of the magnetic attraction head 1, which reduces the wear between the instrument running in the cavity 5 and the magnetic attraction head 1, and reduces the influence of the annular magnetic block on the instrument running in the cavity 6.

[0044] See also Figure 3-5 , a guided magnetic balloon catheter device for branch artery reconstruction, comprising a guiding catheter 9, a magnetized catheter 8, a magnetic balloon 10, a magnetic liquid injection device 12, and a guiding wire 11; the guiding catheter 9 and the magnetized catheter 8 are fixed side by side; the magnetic balloon 10 is a double-layer balloon wall structure, and an annular cavity is formed between the double-layer balloon walls, the annular cavity is filled with magnetic liquid, and a through hole is provided in the center; the head of the magnetized catheter 8 is connected to the magnetic balloon 10, and the tail is connected to the magnetic liquid injection device 12; the head of the guiding catheter 9 is connected to the through hole of the magnetic balloon 10 and is not connected to the inside of the magnetic balloon 10; the guiding wire 11 penetrates into the guiding catheter 9, and the front end passes through the through hole; the head of the magnetic balloon 10 is provided with a marking circle 14, and except for the marking circle 14, the rest of the outer balloon wall has a magnetic isolation layer that can isolate magnetism; the head of the magnetic balloon 10 has a balloon head end 15 with a gradually decreasing diameter and easy to bend with the marking circle 14 as the starting point.

[0045] In this embodiment, see Figure 3 The tail end of the guide catheter 9 is connected to an extracorporeal catheter delivery system 13 and can be delivered into the blood vessel cavity by the catheter delivery system 13 .

[0046] In this embodiment, continue to see Figure 3 , and also includes a magnetic liquid injection device 12 connected to the tail of the magnetized catheter 8, and the expansion and retraction of the magnetic balloon 10 are controlled by the magnetized catheter 8 and the magnetic liquid injection device 12.

[0047] See also Figure 3-6 , the names and left and right of each component are described in detail below:

[0048] The magnetized catheter 8 has a head end opening connected to the balloon 10 and a tail end connected to a magnetic liquid injection device 12, which is parallel to the guide catheter 9. The operator injects magnetic liquid to control the expansion and retraction of the balloon 10, making the balloon magnetic.

[0049] Guide catheter 9: The head end opens at the head end of the balloon 10, and the tail end is connected to the extracorporeal catheter delivery system 13, and can be delivered into the blood vessel cavity by the catheter delivery system 13. The guide wire 11 and other intravascular treatment instruments can run inside it. The connection between the head and the balloon 10 is an adjustable curved sheath, which is convenient for the guiding part to be parallel to the main stent and the balloon to be positioned in the branch blood vessel; in specific applications, according to each person's different blood vessel distribution and treatment needs, any catheter structure such as single curved tube, double hook, hunter head, special-shaped tube, Simon wire series, pigtail tube, cobra tube, etc. can be selected to meet the needs of different occasions.

[0050] Magnetic balloon 10: It is a double-layer balloon wall structure. Except for the head and tail ends of the balloon, the balloon wall of other parts is continuous. The expansion and retraction of the balloon 10 are controlled by the magnetized catheter 8 and the magnetic liquid injection device 12. After the magnetic liquid is filled, the balloon 10 expands and becomes magnetic. Except for the marking circle 14, the rest of the outer balloon wall is a carbon fiber structure to isolate magnetism. The main body of the magnetic balloon separates the main covered stent 9 and the abdominal aorta wall by a layer of distance. The balloon head 15 enters the branch artery under the guidance of the guide wire 11, and the marking circle 14 is tangent to the opening of the branch artery. The rest of the parts remain outside the opening of the branch artery, so as to locate the branch artery without isolating the branch blood supply, and to leave space for in situ windowing. The marking circle 14 can be attracted and positioned with the magnetic attraction head 1. After the magnetic liquid is sucked out, the balloon 10 is retracted and loses its magnetism, and is separated from the magnetic attraction head.

[0051] The guide wire 11 runs in the guide catheter 9 and is used to help deliver the magnetized catheter into the blood vessel cavity, locate in the branch artery and cooperate with the balloon tip 15 to guide the position of the branch artery.

[0052] Magnetic liquid injection device 12: contains magnetic liquid with opposite magnetism to the magnetic attraction head 1, controls the expansion and retraction of the balloon 10 through injection and suction operations, and the operator can determine the amount of magnetic liquid to be filled according to different anatomical characteristics to change the volume of the balloon 10.

[0053] Catheter delivery system 13: used to deliver intracavitary therapeutic devices such as magnetized catheter 8, guide catheter 9, magnetic balloon 10 and guide wire 11 into the blood vessel cavity and control their movement

[0054] Marking circle 14: The outer wall of the marking circle is made of magnetic conductive material. After the magnetic liquid is injected through the magnetizing conduit 8, the magnetism at the marking circle is the strongest, and it can attract the magnetic attraction head 1.

[0055] The balloon tip 15 is a cone-shaped structure, located at the tip of the magnetic balloon 10, and enters the branch artery under the guidance of the guide wire 11, without being close to the blood vessel wall, thereby ensuring the blood supply of the branch artery.

[0056] The magnetic balloon adjustable sheath 16 includes components 8-11.

[0057] For specific implementation, see Figure 7 The following steps can be used to locate and guide the right renal artery during right renal artery branch reconstruction during arterial stenting:

[0058] S1. Send the adjustable sheath 16 of the magnetic balloon into the aortic cavity along the arterial puncture point, and with the help of the guide wire 11, send the balloon head 15 of the magnetic balloon 10 along the aorta to the renal artery, adjust the position of the balloon 10, make the marking circle 14 tangent to the opening of the renal artery, expand the balloon 10 through the magnetic liquid injection device 12, guide the guide wire 11 and the balloon head 15 in the renal artery, locate the renal artery while not completely isolating the visceral blood supply, and make the rest of the magnetic balloon 10 close to the abdominal aorta wall.

[0059] S2. The main stent graft 15 is partially released into the aorta using the parallel stent technology. 14 runs outside the stent graft. Magnetic liquid is injected through the magnetic liquid injection device 12 to expand the balloon 10. The balloon 10 is closely attached to the main stent graft 15, leaving a window space between the abdominal aorta and the stent graft.

[0060] S3. Puncture from the femoral artery or percutaneously and deliver the adjustable magnetic sheath 4 containing the magnetic attraction head 1 into the femoral artery cavity, so that the adjustable magnetic sheath runs along the femoral artery and aorta and is delivered into the coated stent to reach the vicinity of the renal artery; during the puncture process, a guide wire can be used in the cavity 5 to help the magnetic catheter reach the vicinity of the renal artery.

[0061] S4. Adjust the position and direction of the adjustable bend 2, and rotate the magnetic attraction head 1 toward the opening of the right renal artery.

[0062] S5. The magnetic attraction head 1 is adsorbed by the mutual attraction between the marking ring 14 on the magnetic balloon 10 outside the main covered stent at the opening of the renal artery and the magnetic sheath 4 .

[0063] S6. The mutual attraction between the magnetic sheath 4 and the marking circle 14 can indicate the position of the renal artery opening from inside the aortic stent graft and keep the magnetic attraction head 1 facing the branch artery opening. The laser catheter 7 is sent into the cavity 5 and reaches the renal artery opening (inside the stent graft). The in vitro laser therapy device connected to the tail of the laser fiber is started to accurately burn the opening of the right renal artery on the stent graft.

[0064] S7. After the intravascular treatment is completed, the magnetic liquid is sucked out through the magnetic liquid injection device 12, the balloon 10 is recovered and loses its magnetism, and is separated from the magnetic attraction head 1, and the magnetic balloon adjustable sheath 14 is withdrawn along the blood vessel cavity, thus completing the operation.

[0065] Based on the existing patent CN114767327A, the utility model improves the structure of the branch artery magnetic navigation catheter, and designs its head into a magnetic balloon. The head of the magnetic balloon is provided with a marking circle. In addition to the marking circle, the remaining outer balloon wall has a magnetic isolation layer that can isolate magnetism, thereby cleverly forming a circle of parts that can be magnetically adsorbed on the magnetic balloon; at the same time, the head of the magnetic balloon has a balloon head end with a gradually decreasing diameter and easy to bend under the drive of the guide wire, which can cleverly realize the adsorption function with the adjustable magnetic bending sheath, thereby accurately realizing the window positioning of the corresponding part of the coated stent and the renal artery during surgery. Compared with the existing positioning method of CN114767327A, the positioning of the marking circle in the utility model is more convenient, has strong fault tolerance, and significantly improves the reliability of positioning.

[0066] Furthermore, it solves the problem of difficult accurate positioning of the window opening, shortens the positioning time, reduces the blood flow isolation time window, restores the blood supply to the visceral branches as soon as possible, and reduces the postoperative visceral injury rate; accurately locates the branch artery opening, reduces the possibility of stent displacement and postoperative internal leakage, and enables the branch artery stent and the main stent to accurately open and fit during the operation.

[0067] The above are preferred embodiments of the present invention. Ordinary technicians in this field can also make their own changes or improvements on this basis. Without departing from the overall concept of the present invention, these changes or improvements should fall within the scope of protection required by the present invention.

Claims

1. A guided magnetic balloon catheter device for branch artery reconstruction, characterized in that: It comprises a guiding catheter (9), a magnetized catheter (8), a magnetic balloon (10), a magnetic liquid injection device (12), and a guiding wire (11); The guide catheter (9) and the magnetized catheter (8) are fixed side by side; The magnetic balloon (10) has a double-layered balloon wall structure, with an annular cavity formed between the double-layered balloon walls. The annular cavity is filled with magnetic liquid and has a through hole in the center. The head of the magnetized catheter (8) is connected to the magnetic balloon (10), and the tail is connected to the magnetic liquid injection device (12); The head of the guide catheter (9) is connected to the through hole of the magnetic balloon (10) and is not connected to the interior of the magnetic balloon (10); The guide wire (11) is inserted into the guide catheter (9), and the front end thereof passes through the through hole; The head of the magnetic balloon (10) is provided with a marking circle (14), and except for the marking circle (14), the rest of the outer balloon wall has a magnetic isolation layer capable of isolating magnetism; the head of the magnetic balloon (10) has a balloon head end (15) with a gradually decreasing diameter and which is easily bent under the drive of a guide wire.

2. The guided magnetic balloon catheter device for branch artery reconstruction according to claim 1, characterized in that: The tail end of the guide catheter (9) is connected to an extracorporeal catheter delivery system (13) and can be delivered into the blood vessel cavity by the catheter delivery system (13).

3. The guided magnetic balloon catheter device for branch artery reconstruction according to claim 1, characterized in that: It also includes a magnetic liquid injection device (12) connected to the tail of the magnetized catheter (8), and the expansion and retraction of the magnetic balloon (10) are controlled by the magnetized catheter (8) and the magnetic liquid injection device (12).

Images