Endarterium fixing device and endarterium fixing method

Abstract

The invention discloses an endangium fixing device and an endangium fixing method, and belongs to the field of medical instruments, the far end of an inner core sleeved in an outer sheath is an elastic support capable of automatically expanding and sequentially surrounded by a plurality of skeletons, an inner cavity is communicated with a guide wire cavity of the inner core, and a rivet is mounted on the outer surface of the elastic support; after the intimal fixator passes through the flow-limiting interlayer along the guide wire, the sheath is withdrawn, the elastic support is released, the elastic support is automatically expanded, and the rivet is unfolded in a barb shape; the inner core is withdrawn, the barbs penetrate into the blood vessel wall and fall off from the elastic support, and an interlayer in the blood vessel cavity is fixed; and the outer sheath is pushed, the elastic stent is recovered into the outer sheath, and the intima of the artery is fixed. The invention has the advantages that: for the serious interlayers generated after simple endarterium injury caused by trauma and artery occlusion lesion balloon dilatation molding, the injured endarterium can be fixed, and the generation of flow-limiting interlayers can be reduced or avoided, so that the use of the stent is reduced, the treatment cost is reduced, and the long-term treatment effect is improved.

Description

Technical Field

[0001] The present invention relates to medical devices and methods used in arterial vascular interventional surgery, and in particular to an arterial intima fixation device and an arterial intima fixation method. Background Art

[0002] Among the current endovascular interventional treatments for lower limb arterial stenosis and occlusive lesions, the most basic method is balloon angioplasty. The most common problem after balloon angioplasty is that intimal damage often occurs after the operation, leading to arterial dissection. Figure 1 Figure A is the stenosis site of the blood vessel, Figure B shows the placement of the balloon catheter, Figure C shows the radioactive force generated by the expansion balloon acting on the plaque, and Figure D shows the plaque rupture and dissection that can usually be observed at the end of the operation. Severe dissection (flow-limiting dissection) will affect arterial blood flow and cause acute vascular occlusion. According to the data from Iida, Osamu, Yokoi, et al. Angiographic Dissection Patterns and Patency Outcomes After Balloon Angioplasty for Superficial Femoral Artery Disease [J]. Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists, 2017, 24 (3): 367-375., the proportion of severe dissections after balloon angioplasty can be as high as 42%, such as Figure 2 The CDEF diagram indicates a severe dissection, requiring stent implantation to eliminate the impact of the dissection on blood flow. In summary, current devices and methods are designed to minimize the occurrence of dissections. Once a flow-limiting dissection occurs, stent implantation is the only solution to prevent it from impacting blood flow.

[0003] Currently, the long-term efficacy of peripheral arterial stent implantation is unsatisfactory. Therefore, recent clinical research focuses on how to better prepare blood vessels, reduce the occurrence of dissections, and thus reduce the need for stent implantation. Balloon angioplasty, as the primary treatment, is both the foundation and the focus. Current measures include the use of long balloons, prolonged dilation, progressive dilation, constrained balloons, and high-pressure balloons. While these methods have reduced the incidence of flow-limiting dissections, they are still a possibility. Once a severe dissection occurs, stent implantation is the only solution.

[0004] Balloon angioplasty followed by stent implantation is a common treatment for arterial stenosis or occlusion. However, stent implantation can lead to intimal hyperplasia. Severe intimal hyperplasia can gradually lead to stenosis or occlusion of the arterial lumen, a condition known as in-stent restenosis or occlusion. The incidence and duration of in-stent restenosis vary across different locations and are generally related to arterial diameter and stress. Therefore, infragroin arteries are significantly more likely to experience in-stent restenosis than infragroin arteries. Due to the complex stress distribution of the femoral artery, in addition to in-stent restenosis, stent fracture is also a risk. Furthermore, in transarticular sites (such as the common femoral and popliteal arteries), prolonged activity after stent implantation increases the risk of metal fatigue and stent fracture. These sites are often referred to as non-stented areas, but in practice, they often experience severe dissections, necessitating stent implantation. Patency rates after re-intervention following in-stent restenosis are significantly reduced. Therefore, stent implantation is often a remedial measure or a last resort when adequate blood flow cannot be maintained after balloon angioplasty. Current clinical research focuses on utilizing new technologies and devices to reduce the incidence of severe dissections and thus reduce the number of stents implanted. Summary of the Invention

[0005] The purpose of the present invention is to overcome the above-mentioned defects and provide an arterial endothelial fixation device and an arterial endothelial fixation method. For severe dissections that have occurred after balloon angioplasty, the damaged endothelium can be fixed, reducing or avoiding the occurrence of flow-limiting dissections, thereby reducing the use of stents, reducing treatment costs, and improving long-term treatment effects.

[0006] The objective of the present invention is achieved through the following technical solution: an arterial intima fixation device, characterized in that it includes an outer sheath and an inner core sleeved in the outer sheath, the outer sheath is a hollow long tube, a guidewire cavity is provided in the middle of the inner core sleeved in the outer sheath, the distal end of the inner core is an automatically expandable elastic bracket, the elastic bracket is surrounded by two or more skeletons in sequence and fixed to the distal end of the inner core, the inner cavity of the elastic bracket is connected to the guidewire cavity of the inner core, and rivets are installed on the outer surface of the elastic bracket.

[0007] The rivet is fixed on the outer surface of the elastic bracket in a barb shape.

[0008] The rivet is made of medical absorbable material.

[0009] The distal end of the outer sheath is a flush end, and the proximal end is a bell mouth.

[0010] The proximal end of the inner core is a bell mouth.

[0011] An arterial intima fixation method using the arterial intima fixation device is characterized by comprising the following steps:

[0012] Step 1: The inner core is placed inside the outer sheath, a guide wire is inserted into the guide wire lumen of the inner core, the intimal fixation device is inserted into the blood vessel, and the intimal fixation device passes through the flow-limiting dissection along the guide wire;

[0013] Step 2: After the arterial intimal fixation device reaches the flow-limiting dissection, it is positioned. After positioning, the outer sheath is withdrawn proximally, releasing the elastic stent at the distal end of the inner core from the outer sheath. The elastic stent automatically expands, and the rivets on the surface of the elastic stent unfold like barbs.

[0014] Step 3: The inner core is withdrawn proximally. At this time, the barbed rivets of the elastic stent just penetrate the blood vessel wall. The barbed rivets fall off the outer surface of the elastic stent and fix the flow-limiting interlayer in the blood vessel lumen.

[0015] Step 4: Push the outer sheath distally and retract the elastic stent into the outer sheath to complete the fixation of the arterial intima.

[0016] The beneficial effects of the present invention are:

[0017] For simple intimal damage caused by trauma and severe dissection that has occurred after balloon angioplasty for arterial occlusive lesions, the damaged intima can be fixed, reducing or avoiding the occurrence of flow-limiting dissections, thereby reducing the use of stents, lowering treatment costs, and improving long-term treatment effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a coronal image of intimal damage and dissection after balloon dilation.

[0019] Figure 2 It is a sandwich type image.

[0020] Figure 3 It is a cross-sectional schematic diagram of the normal vascular intima, media, and adventitia.

[0021] Figure 4 It is a schematic cross-sectional view of a severe dissection (flow-limiting dissection) caused by vascular intima damage.

[0022] Figure 5 This is a diagram of the vascular anatomy that shows a dissection after balloon dilation.

[0023] Figure 6 This is a diagram of the blood vessel anatomy showing that the dissection disappears and blood flow is unobstructed after stent implantation.

[0024] Figure 7 This is a schematic diagram of the cross-section of a blood vessel covered with a stent after severe dissection.

[0025] Figure 8 It is a schematic diagram of the outer sheath structure.

[0026] Figure 9 It is a schematic diagram of the inner core structure.

[0027] Figure 10 This is an enlarged image of the rivet: point A penetrates the blood vessel wall; segment BC fixes the endothelium; point B is connected to the elastic stent.

[0028] Figure 11 Schematic diagram of the endometrial fixation device assembly.

[0029] Figure 12 This is a schematic diagram of the release of the elastic stent of the endometrial fixation device.

[0030] Figure 13 This is a flow chart of the inner membrane fixation process.

[0031] in:

[0032] 1-outer sheath, 2-inner core, 3-guidewire, 4-elastic stent, 5-rivet, 6-flow-limiting interlayer. DETAILED DESCRIPTION

[0033] Example: Figure 8-12 As shown, an arterial intima fixation device comprises an outer sheath 1 and an inner core 2 sleeved in the outer sheath 1, wherein the outer sheath 1 is a hollow long tube, the distal end of the outer sheath 1 is a flush end, and the proximal end is a bell mouth, which is convenient for withdrawal and advancement, and the inner core 2 is sleeved in the outer sheath 1, and the inner core 2 comprises a body and a proximal end and a distal end located at both ends of the body, the proximal end of the inner core 2 is a bell mouth, which is convenient for a guide wire 3 to enter, and the body of the inner core 2 is provided with a guide wire cavity. When in use, the guide wire 3 is inserted into the guide wire cavity, and the distal end of the inner core 2 is an automatically expandable elastic bracket 4, the elastic bracket 4 is provided with a proximal end and a distal end located at both ends of the body, and the proximal end of the inner core 2 is a bell mouth, which is convenient for a guide wire 3 to enter, and the body of the inner core 2 is provided with a guide wire cavity. When in use, the guide wire 3 is inserted into the guide wire cavity, and the distal end of the inner core 2 is an automatically expandable elastic bracket 4. The bracket 4 is surrounded by N skeletons in sequence and fixed at the distal end of the inner core. The inner cavity of the elastic bracket 4 is connected with the guide wire cavity of the inner core 2. A number of rivets 5 are bonded to the outer surface of the elastic bracket 4. The rivet 5 can be designed to be L-shaped. The three endpoints of the L-shaped rivet 5 are A, B, and C respectively. The B point of the L-shape is bonded to the outer surface of the elastic bracket 4. The AB long side of the L-shape is arranged in a reverse thorn shape with the axis of the inner core 2. The rivet 5 is made of absorbable medical material. After the interlayer is fixed for a period of time, the rivet is absorbed and the foreign body reaction is small.

[0034] Example 2: A method for performing arterial intima fixation using the arterial intima fixation device of Example 1, comprising the following steps:

[0035] Step 1: The inner core 2 is placed inside the outer sheath 1, the guide wire 3 is inserted into the guide wire lumen of the inner core 2, the arterial intima fixation device is inserted into the blood vessel, and the arterial intima fixation device passes through the flow-limiting interlayer 6 along the guide wire 3;

[0036] Step 2: After the arterial intima fixation device reaches the flow-limiting dissection 6, it is positioned. The positioning method is a conventional surgical positioning method and will not be described in detail here. After positioning, the outer sheath 1 is withdrawn proximally to release the elastic support 4 at the distal end of the inner core 2 from the outer sheath 1. The elastic support 4 automatically expands and the rivets 5 on the surface of the elastic support 4 also automatically expand. The expanded rivets 5 are arranged in a barb-like manner with the elastic support 4;

[0037] Step 3: Retract the inner core 2 toward the proximal end. At this time, the A end of the barbed rivet 5 of the elastic stent 4 penetrates the blood vessel wall. Continue to retract the inner core 2, so that the barbed rivet 5 falls off the outer surface of the elastic stent 4. The BC end of the barbed rivet 5 fixes the interlayer 6 in the blood vessel cavity.

[0038] Step 4: The outer sheath 1 is pushed distally, and the elastic stent 4 is retracted into the outer sheath 1 to complete the fixation of the arterial intima.

[0039] This arterial intima fixing device uses a rivet 5 to fix the arterial intima that affects blood flow. When using this device and method, the rivet 5 contacts the blood vessel wall by relying on the expansion force of the self-expanding elastic stent 4. The rivet 5 penetrates the blood vessel wall by withdrawing the inner core 2 to drive the barbed rivet 5 to move. The blood vessel wall is relatively fixed. The rivet 5 penetrates the blood vessel wall as the inner core 2 is withdrawn. The penetrated rivet 5 is relatively fixed to the blood vessel wall. The inner core 2 continues to withdraw, and the rivet 5 is separated from the elastic stent 4 of the inner core 2. The rivet 5 fixes the blood vessel intima to the blood vessel wall, reducing or avoiding the occurrence of flow-limiting dissections, thereby reducing the use of stents, reducing treatment costs, and improving long-term treatment effects.

Claims

1. An arterial intima fixation device, characterized in that: It includes an outer sheath and an inner core inserted in the outer sheath, wherein the outer sheath is a hollow long tube, a guidewire cavity is arranged in the middle of the inner core inserted in the outer sheath, the distal end of the inner core is an automatically expandable elastic support, the elastic support is surrounded by two or more skeletons in sequence and fixed at the distal end of the inner core, the inner cavity of the elastic support is connected with the guidewire cavity of the inner core, and rivets are installed on the outer surface of the elastic support.

2. The arterial intima fixation device according to claim 1, characterized in that: The rivet is fixed on the outer surface of the elastic bracket in a barb shape.

3. The arterial intima fixation device according to claim 1 or 2, characterized in that: The rivet is made of medical absorbable material.

4. The arterial intima fixation device according to claim 1, characterized in that: The distal end of the outer sheath is a flush end, and the proximal end is a bell mouth.

5. The arterial intima fixation device according to claim 1, characterized in that: The proximal end of the inner core is a bell mouth.

6. An arterial intima fixation method using the arterial intima fixation device according to claims 1 to 5, characterized in that: The steps include: Step 1: The inner core is placed inside the outer sheath, a guide wire is inserted into the guide wire cavity of the inner core, the arterial intima fixation device is inserted into the blood vessel, and the arterial intima fixation device passes through the flow-limiting dissection along the guide wire; Step 2: After the arterial intimal fixation device reaches the flow-limiting dissection, it is positioned. After positioning, the outer sheath is withdrawn proximally, so that the elastic stent at the distal end of the inner core is released from the outer sheath, and the elastic stent automatically expands and stretches, and at the same time, the rivets on the surface of the elastic stent are unfolded in a barb shape; Step 3: The inner core is withdrawn toward the proximal end, and the barbed rivets of the elastic stent are inserted into the blood vessel wall. The barbed rivets fall off from the outer surface of the elastic stent and fix the flow-limiting interlayer in the blood vessel cavity. Step 4: Push the outer sheath distally and retract the elastic stent into the outer sheath to complete the fixation of the arterial intima.

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