WO2021103982A1

WO2021103982A1 - Degradable patch for treating aneurysm, and blood directing system

Info

Publication number: WO2021103982A1
Application number: PCT/CN2020/126989
Authority: WO
Inventors: 张海军; 侯文博; 李建文; 周文秀; 王燕; 房艺
Original assignee: 张海军
Priority date: 2019-11-27
Filing date: 2020-11-06
Publication date: 2021-06-03
Also published as: CN110934661B; CN110934661A

Abstract

The present invention relates to the field of medical instruments. Provided are a degradable patch (100) for treating an aneurysm, and a blood directing system. The degradable patch (100) comprises a patch main body (110) and an adhesive (120) positioned at an edge of the patch main body (110). The patch main body (110) is made of a degradable material. The degradable patch (100) has favorable wall apposition, can effectively prevent an instrument from moving, and does not affect flow of blood in a branch vessel while occluding an aneurysm.

Description

Degradable patch and blood flow guiding system for treating aneurysm

Technical field

The invention relates to a degradable patch and a blood flow guiding system for treating aneurysms, belonging to the field of interventional medical devices.

Background technique

Vascular aneurysm is due to the disease or injury of the arterial wall, which forms the performance of localized or diffuse expansion or bulging of the arterial wall, with swelling and pulsating masses as the main manifestations. Aneurysms can occur in any part of the arterial system, depending on where the aneurysm appears, including cerebral aneurysms, visceral aneurysms, peripheral aneurysms, abdominal aortic aneurysms, etc.

Interventional therapy is currently an important means of treating aneurysms. In interventional therapy, a commonly used method is to implant releasable balloons, coils and other embolic materials into the aneurysm body through a catheter, so that the blood flow in the tumor body is significantly slowed down or stagnated, and gradually Thrombus is formed to block the tumor body, thereby achieving the purpose of preventing the rupture of the aneurysm.

However, the above-mentioned interventional embolization therapy has obvious defects in the treatment of large (diameter greater than 10mm) or huge (diameter greater than 25mm) aneurysms: because the effect of coils in the treatment of aneurysms is related to the degree of dense embolization, this The surgeon is required to place as many coils as possible during the operation. Therefore, in the treatment of wide-necked and giant aneurysms, coil embolization will cause more obvious gravity and space-occupying effects, and the recurrence rate after surgery is also very high. high. In this context, a new intracranial aneurysm treatment device came into being, that is, the blood flow guide device.

In recent years, a blood flow guiding device, also known as a dense mesh stent, has effectively overcome the shortcomings of the tamponade coil therapy in the treatment of large or huge aneurysms. The mechanism of the blood flow guiding device is that it interferes with the blood flow from the tumor-bearing artery into the aneurysm, causing the blood in the aneurysm to block and stagnate, leading to thrombosis in the aneurysm, and further promoting its complete closure. The current blood flow guide devices on the market are mainly Pipeline Embolization Device (Covedien/ev3), Silk stent (Balt Extrusion), Tubridge (MicroPort Shentong Medical Technology (Shanghai) Co., Ltd.), etc. The Pipeline is braided by 32 metal wires with a metal coverage rate of 30% to 35%. The delivery method consists of a delivery guide wire and a matching 3F microcatheter. At present, more than 2,600 patients have been treated by Pipeline. Silk stent is the first blood flow guiding device approved for clinical treatment. It is composed of 48 nickel-titanium alloys, and its metal coverage is 35%-50%. Its delivery method is also a guide wire and a supporting microcatheter. The micro-catheter has the function of re-recovering the stent. When the release of the stent does not exceed 80%, the stent can be re-recovered into the catheter, thereby realizing the movement and relocation of the stent. The Tubridge device is a domestic dense mesh stent jointly developed by MicroPort Shentong Medical Technology (Shanghai) Co., Ltd. and Shanghai Changhai Hospital. Its composition and principle are roughly the same as the first two, with a mesh rate of 60%-80%. It is transported in the Tubridge device. During the process, the metal coverage at the neck of the aneurysm can be increased to 30%-70% through the cooperation of the guide wire and the microcatheter, while the metal coverage at other locations is only 12%-20%.

The adherence, shortening rate, and influence on the blood flow of branch vessels after the implantation of the vascular guide device are important indicators to ensure its effectiveness.

Summary of the invention

The purpose of the present invention is to provide a degradable patch for the treatment of aneurysms, the patch is made of degradable materials, the degradation process and products will not cause damage to the human body, high safety, and the patch The wall is good, which can effectively reduce the phenomenon of device displacement, and will not affect the blood flow of branch vessels while occluding the aneurysm.

The specific technical scheme of the present invention is as follows:

A degradable patch for treating aneurysms, that is, a blood flow guiding device, comprises a patch body and an adhesive located at the edge of the patch body, the patch body is made of degradable materials.

Further, the section of the patch body is arched, the radius is 2.0-10mm, the central angle is 45°-270°, the length of the patch body is 5-50mm, and the thickness of the patch body is 0.05-1mm.

Further, the patch body is not closed in the circumferential direction and does not cover the branch blood vessels, so the blood flow of the branch blood vessels will not be affected while the aneurysm is occluded.

Further, the patch body is a non-porous solid structure or a porous structure. The porosity of the porous patch body is 10%-70%.

Further, the non-porous solid patch body is made of a biodegradable material through a plate molding method or an injection molding method. The degradable material used here is preferably a polymer degradable material, which can be prepared by the existing flat plate molding method or injection molding method, and the molding is simple.

Further, the porous patch body is woven from a filamentous degradable material, or is obtained by forming holes in a non-porous solid patch body.

Further, the filamentous degradable material is a degradable metal alloy wire, such as zinc alloy wire, magnesium alloy wire, iron alloy wire or other degradable metal alloy wire, etc., or may be a polymer biodegradable wire, such as Polylactic acid-based biodegradable silk, starch-based biodegradable silk, etc. This filamentous degradable material can be maintained in the body for months or years, and the degradation process and products will not cause harm to the human body. The diameter of metal alloy wire or polymer biodegradable wire is 0.025-0.5mm. The weaving method of the filamentous degradable material can be carried out with reference to the methods disclosed in the prior art, and the size, thickness, shape, porosity, etc. of the weaving can be adjusted according to actual needs.

Further, when the patch body is woven from a filamentous degradable material, the patch body has a relatively high weaving coverage, which can reach 30%-90%. At this time, the sum of braid coverage and porosity is 100%.

Further, the method of forming holes on the non-porous solid patch body can be carried out by the methods disclosed in the prior art. For example, the non-porous solid patch body is made first, and then the solid patch body is formed by mechanical means. Pores are formed on the body; or, when preparing the non-porous solid patch body, a certain proportion of porogen is added to the raw material (the porogen particles can be water-soluble inorganic salts such as sodium chloride, sodium tartrate and sodium citrate, or Sugar particles, paraffin particles or ice particles can also be used. The non-porous solid patch body is made by plate molding or injection molding, and then the porogen is precipitated by the precipitation method to obtain a porous patch body.

Further, an adhesive is provided on the patch body, and the adhesive is located on one surface of the patch body and located at the peripheral edge of the patch body. The adhesive is a soft, biologically compatible double-sided tape, which can form a tough bond between the wet blood vessel wall and the patch body, and has good wall adhesion.

Further, the present invention also provides a blood flow guiding system for treating aneurysms, the blood flow guiding system comprising a delivery system and the above-mentioned degradable patch for treating aneurysms. The delivery system includes a puncture kit, a balloon guiding catheter and a balloon delivery catheter, and the degradable patch for treating aneurysms is located on the outer wall of the balloon of the balloon delivery catheter. In use, the balloon guiding catheter and the balloon delivery catheter are used together to deliver the degradable patch to the desired location.

Further, the puncture kit includes a puncture needle, a micro-guide wire, a catheter sheath, and a dilator.

Further, the degradable patch is pressed on the outer wall of the balloon of the balloon delivery catheter, and the biocompatible adhesive is coated on the periphery of the degradable patch. The degradable patch is delivered to the aneurysm through interventional methods, and the expansion After the balloon, the neck of the aneurysm is fully covered, which can effectively reduce the blood flowing into the aneurysm. The degradable patch of the present invention has good adhesion to the wall, can effectively reduce the phenomenon of device displacement, and will not affect the blood flow of branch vessels while occluding the aneurysm.

The beneficial effects of the present invention are:

1. The degradable patch of the present invention is bonded to the inner wall of the blood vessel with a biocompatible adhesive, which can achieve good adhesion and can avoid the phenomenon of device displacement after implantation;

2. The degradable patch of the present invention does not close in the circumferential direction and does not cover the branch blood vessels, so it will not affect the blood flow of the branch blood vessels while occluding the aneurysm.

3. The overall volume of the degradable patch of the present invention is small, the occupancy rate in the blood vessel is reduced, the restenosis in the blood vessel and the formation of intravascular thrombus can be effectively reduced, and it is more safe and reliable.

Description of the drawings

Figure 1 is a schematic diagram of the structure of a woven degradable patch.

Figure 2 is a schematic diagram of the structure of a non-porous material-type degradable patch.

Figure 3 is a schematic diagram of the structure of a porous material-type degradable patch.

Figure 4 is a cross-sectional view of a degradable patch with a central angle of 90°.

Figure 5 is a cross-sectional view of a degradable patch with a central angle of 120°.

Figure 6 is a cross-sectional view of a degradable patch with a central angle of 180°.

Figure 7 is a cross-sectional view of a degradable patch with a central angle of 270°.

Figure 8 is a diagram of the placement position of the degradable patch (an axial cut view of the tumor-bearing blood vessel).

Fig. 9 is a diagram of the placement position of the degradable patch (a sectional view of the axis of the tumor-bearing blood vessel).

Fig. 10 is a schematic diagram of the structure of a balloon guiding catheter and a balloon delivery catheter.

Fig. 11 is a schematic diagram of the structure of the balloon delivery catheter after being placed in the balloon guiding catheter.

FIG. 12 is a schematic diagram of the structure of a balloon fixed with a degradable patch.

Figure 13 is a schematic diagram of the degradable patch transportation process.

Detailed ways

The present invention will be further described below in conjunction with specific drawings.

As shown in Figures 1-3, the degradable patch 100 of the present invention is composed of a patch body 110 and a biocompatible adhesive 120. The adhesive is located on the peripheral edges of the patch body, and is only located on the patch body. On one surface. The patch body is made of degradable material. The patch body is not closed in the circumferential direction, the section is arched, the radius is 2.0-10mm, the central angle is 45°-270°, the length is 5-50mm, and the thickness is 0.05-1mm.

Further, the patch body 110 may have a porous structure. As shown in FIG. 1, the patch body may be woven from a filamentous degradable material, and the filamentous degradable material used may be a metal alloy wire or a polymer. Biodegradable wire, such as zinc alloy, magnesium alloy, iron alloy, etc., and polymer biodegradable wire such as polylactic acid, starch-based, etc. The diameter of the filamentous degradable material is 0.025-0.5mm, and the degradable filament begins to degrade after being implanted in the body for 3 months to 3 years. The patch body 110 can be woven with a 48-, 64-, 72-, or 144-spindle medical precision knitting machine, with a knitting density of 70-200 PPI. The woven patch body has a higher woven coverage, which can reach 30%-90%, and the porosity is 10%-70%.

Further, the patch body 110 may also be a solid structure. As shown in FIG. 2, the patch body 110 may also be made of a non-porous material. The non-porous material may be made of silica gel, polylactic acid and other polymers. It is made of degradable materials, and the preparation method can be made by flat plate molding or injection molding process.

Further, the patch body 110 may also be a porous structure as shown in FIG. 3, and the porous structure may be improved on the basis of the non-porous structure shown in FIG. 2, for example, the non-porous structure shown in FIG. Pore structure, and then further pore-forming treatment to obtain a porous structure, or when preparing the above-mentioned non-porous structure, a certain proportion of porogen is added to the raw material, and then the porogen is precipitated by the precipitation method to obtain a porous structure. The pore size and porosity of the porous structure can be adjusted by selecting the particle size and content of the porogen, and the porosity is 10%-40%.

Figures 4-7 are cross-sectional views of the degradable patch 100, showing different specifications in the circumferential direction of the patch. The degradable patch 100 is not closed in the circumferential direction, and such an unclosed design can effectively avoid affecting the blood flow of branch vessels. In the circumferential direction, whether the degradable patch 100 can cover at least 1.2-1.8 times of the neck of the aneurysm, the central angle α ranges from 45° to 270°. The radius r of the degradable patch can be determined according to the diameter R of the tumor-bearing blood vessel, and the range is 2.0-10.0mm. In the axial direction, the degradable patch 100 should cover at least the neck of the aneurysm and extend 5-10 mm to both sides. Therefore, the specification selection of the degradable patch can be summarized as the following formula:

r=R (1)

L=L′+5～10mm (2)

Explanation: r is the radius in the circumferential direction; R is the diameter of the tumor-bearing vessel; L is the length in the axial direction; L'is the length of the aneurysm neck; α is the central angle in the circumferential direction.

According to the above formula, the length of the degradable patch is generally 5-50mm.

As shown in Figures 1-3, the adhesive 120 is a soft, biocompatible double-sided tape that is evenly and evenly adhered to the periphery of the degradable patch 100. The adhesive 120 can be Absorb the moisture on the surface of the wet tissue within seconds, and at the same time form the cross-linking of physical bonds and covalent bonds with the tissue, strongly bond various soft and wet tissues in the body and implanted equipment, and maintain high bonding strength, high flexibility, and high biology for a long time. Compatibility, final biodegradation, and it needs to be ensured that the adhesive 120 starts to degrade at least 1-3 days longer than the degradable patch 100.

Figures 10-12 show schematic structural diagrams of a blood flow guiding system for treating aneurysm, which includes a balloon delivery system 300 and the above-mentioned degradable patch 100. The degradable patch 100 is inserted into a designated position through the delivery system 300. The balloon delivery system 300 includes a balloon delivery catheter 310, a balloon guiding catheter 320, and a conventional puncture kit, which includes a puncture needle, a micro-guide wire, a catheter sheath, and a dilator. As shown in FIG. 10, the A channel of the balloon guiding catheter 320 is an inflation channel, and the balloon 321 can be expanded to a certain extent by a pressure pump. The B channel is the assembly channel of the balloon delivery catheter 310. The C channel of the balloon delivery catheter 310 is an inflation channel, and the degradable patch 100 is attached to the inner wall of the tumor-bearing blood vessel by expanding the balloon 311. The D channel is the channel of the micro-guide wire. The balloon delivery catheter 310 also includes a balloon 311, and the visualization line 312 is located on one side of the balloon 311. The visualization material may be a visualization material commonly used in medical treatment, such as barium sulfate, bismuth, or tungsten. The assembly process is as follows: the degradable patch 100 is first fixed on the outer wall of the balloon delivery catheter 310 by a crimping device, and the degradable patch is installed on the outer wall of the balloon 311 symmetrically with respect to the development line 312, as shown in FIG. 12 . Then penetrate the distal end of the balloon guide catheter 320 and pass through the reserved holes of the internal fixation frames 322 and 323 to ensure the coaxiality of the balloon delivery catheter 310 and the balloon guide catheter 320, as shown in FIG. 11

The conveying process of the present invention is shown in Figure 13:

S1. Femoral artery puncture, insert the 6F catheter sheath, send the micro-guide wire along the catheter sheath to the tumor-bearing blood vessel, and then send the balloon guiding catheter 320 containing the balloon delivery catheter 310 along the micro-guide wire into close The location of the hemangioma;

S2. Inject liquid to fill the balloon 321 to temporarily block blood flow;

S3. Push out the balloon delivery catheter 310, and determine the release position of the degradable patch according to the relative position of the imaging ring and the aneurysm.

S4. Twist the balloon delivery catheter 310 to observe the relative position of the imaging ring and the imaging line to ensure that the patch can cover the neck of the tumor;

S5. Inject liquid to fill the balloon 311 and keep it for 5-20 seconds to make the degradable patch fully adhere to the tumor-bearing blood vessel wall;

S6. Shrink the balloon and withdraw the balloon delivery catheter together with other instruments from the body. After the operation is completed, the placement position of the degradable patch is shown in Figure 8-9.

The foregoing descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the invention shall be included in the protection scope of the present invention. Inside.

Claims

A degradable patch for treating aneurysms is characterized in that it comprises a patch body and an adhesive located at the edge of the patch body, and the patch body is made of a degradable material.
The degradable patch according to claim 1, wherein the patch body is a non-porous solid structure or a porous structure.
The degradable patch according to claim 2, characterized in that: the non-porous solid patch body is made of degradable material by a flat plate molding method or an injection molding method; the porous patch body is made of filamentous It is woven from degradable materials, or is obtained by forming holes in the body of a non-porous solid patch.
The degradable patch according to claim 3, wherein the filamentous degradable material is a degradable metal alloy wire or a polymer biodegradable wire; preferably, the metal alloy wire comprises a zinc alloy wire , Magnesium alloy wire or iron alloy wire; Preferably, the polymer biodegradable wire includes polylactic acid-based biodegradable wire or starch-based biodegradable wire.
The degradable patch according to claim 3 or 4, wherein the diameter of the filamentous degradable material is 0.025 to 0.5 mm.
The degradable patch according to claim 1, 2, 3 or 4, characterized in that: the cross section of the patch body is arched, the radius is 2.0-10mm, the central angle is 45°-270°, and the patch The length of the body is 5-50mm, and the thickness of the patch body is 0.05-1mm.
The degradable patch according to claim 1, 2, 3 or 4, wherein the patch body is not closed in the circumferential direction.
The degradable patch according to claim 2, characterized in that: the porosity of the porous patch body is 10%-70%; The braiding coverage rate is 30%-90%.
The degradable patch according to claim 1, wherein the adhesive is a double-sided tape with biocompatibility.
A blood flow guidance system for treating aneurysms, which is characterized in that it comprises a delivery system and the degradable patch for treating aneurysms according to any one of claims 1-9, and the delivery system includes a puncture A kit, a balloon guiding catheter and a balloon delivery catheter, the degradable patch for treating aneurysms is located on the outer wall of the balloon of the balloon delivery catheter; preferably, the puncture kit includes a puncture needle and a micro-guide wire , Catheter sheath and dilator.