CN116115399A - Multistage type ball expands tectorial membrane bracket system - Google Patents

Abstract

The invention relates to a multi-section type balloon expandable stent system for treating peripheral vascular stenosis and occlusive lesions, which comprises a plurality of balloon expandable stent frames distributed along the axial direction and a conveying system capable of independently controlling release of each balloon expandable stent frame, so that different stent frames can be accurately released at different lesion positions, and the safety of an operation is improved; the multi-section structure of the invention is beneficial to improving the compliance of the balloon expandable stent system and can improve the passing performance of the delivery system in the body; the invention can treat the blood vessel with lesion area sectionally or single lesion area longer or lesion area with more tortuous, simplify operation, reduce operation time and improve treatment effect.

Description

Multistage type ball expands tectorial membrane bracket system

Technical Field

The invention relates to the field of medical instruments, in particular to a multi-section type ball-expanding tectorial membrane bracket system.

Background

Peripheral vascular disease mainly refers to arterial lumen stenosis and occlusion caused by atherosclerosis, influences blood oxygen supply to surrounding tissues and organs, and then causes ischemia and even necrosis of supplied organs or limbs, and is a non-inflammatory lesion.

Current methods of treatment for peripheral vascular disease are largely divided into two categories: firstly, the statin, the antioxidant, the anti-platelet aggregation and the antihypertensive drugs are used for achieving the treatment effect by anti-inflammatory, antioxidant, endothelial cell protecting, smooth muscle cell proliferation and migration inhibiting, platelet aggregation inhibiting and arterial stiffness improving. And secondly, interventional therapy is carried out at a narrow position by utilizing a peripheral vascular covered stent, a peripheral vascular bare stent or a peripheral balloon.

The peripheral vascular stent graft can be classified into a balloon expandable stent graft and a self-expandable stent graft according to the composition material, supporting force, deformation recovery performance, flexibility and release mode of the stent. Compared with a self-expanding type tectorial membrane stent, the balloon-expanding type tectorial membrane stent has the advantages of high release accuracy and good compression resistance. In clinical use, the balloon expandable stent graft can be released according to the ratio of approximately 1:1 of the diameter of an autologous blood vessel, so that the chronic expansion pressure of the vascular stent graft to the blood vessel can be reduced, the reaction of the blood vessel wall to the stent is lightened, and the possibility of restenosis of the blood vessel is reduced.

Currently, the number of stent graft carried by the balloon expandable stent graft system queried by the prior public information is single (for example, patent CN 108836568A). In clinical use, when the vascular lesion area of a patient is segmented, one-time treatment is difficult to complete by using a single balloon expandable stent, and multiple treatments are required by using a plurality of balloon expandable stent systems carrying the single balloon expandable stent; when the length of a single lesion area of a patient is longer, the compliance of a conveying system is reduced by prolonging the length of a single balloon expandable stent, one-time treatment is difficult to be completed by using the single balloon expandable stent with longer length, and multiple treatments are required by using a plurality of balloon expandable stent systems carrying the single balloon expandable stent; when the vascular lesion area is relatively tortuous, as the balloon expandable stent realizes the release of the stent by means of the inflation of the balloon body, the bending degree of a single stent is limited in a certain range, the single stent is unfavorable for the adhesion with the vascular wall after the release of the stent, the inner leakage is easy to occur, and a plurality of balloon expandable stent systems carrying the single balloon expandable stent with shorter length are also needed to be used for completing the treatment. This can increase the difficulty of the surgeon's operation, extend the duration of the surgery, and increase the risk of the surgery.

Disclosure of Invention

The invention aims to provide a multi-section balloon expandable stent system for treating peripheral vascular stenosis and occlusive lesions, which is used for treating the blood vessels with longer lesion areas or more tortuous lesion areas in a segmented or single lesion area under one-time intervention operation, simplifying operation, reducing operation time and improving treatment effect.

In order to achieve the above purpose, the present invention provides the following technical solutions:

the multi-section type balloon expandable stent-graft system comprises a plurality of balloon expandable stent-grafts distributed along the axial direction and a conveying system capable of independently controlling the release of each balloon expandable stent-graft; the ball expansion tectorial membrane bracket comprises a metal bare bracket and a tectorial membrane; the conveying conduit is a multi-cavity pipe, and the number of the inner cavities is 3-6; the number of the conveying interfaces is 3-6; the delivery hub is connected to the proximal end of the delivery catheter, and one lumen of the delivery catheter is in communication with only one hub of the delivery hub; the number of the ball expansion tectorial membrane brackets is 2-5; the delivery system includes a balloon body, a delivery catheter, a delivery interface, and a visualization marker located at the balloon body.

In the multi-section type ball-expanded tectorial membrane stent system, the length of the ball-expanded tectorial membrane stent is 5-100 mm; the diameter of the ball expansion tectorial membrane bracket is 3-16 mm.

In the multi-section type ball-expanding tectorial membrane stent system, the metal bare stent material of the ball-expanding tectorial membrane stent is selected from one of 316L stainless steel and cobalt-chromium alloy.

In the multi-section type balloon expandable stent system, the balloon expandable stent comprises a drug-loaded stent coated with drugs and a blank stent coated with no drugs; the medicine-carrying tectorial membrane bracket takes tectorial membrane as carrier to carry medicine.

In the multi-section type balloon expandable stent system, the medicine is selected from one or more of rapamycin, rapamycin derivatives, taxol derivatives, probucol, dexamethasone, aspirin, heparin and hirudin.

In the multi-section type balloon expandable stent system, the coating material is selected from one or more of polylactic acid and copolymer thereof, polycaprolactone and copolymer thereof, polylactide and copolymer thereof, medical polydioxanone, polytrimethylene carbonate, polydioxanone, polyglycolic acid, silk fibroin, collagen, gelatin, polytetrafluoroethylene, polyurethane, polyester fabric and silk fabric.

In the multi-section type balloon expandable stent system, the material of the balloon body is one or more selected from nylon (PA), polyethylene terephthalate (PET) and segmented polyether amide resin (PEBAX); the shape of the main body section of the balloon body, which coincides with the balloon expandable stent, is selected from cylindrical or conical.

In the multi-section type balloon expandable stent system, the material for developing the mark is one or more selected from platinum, tungsten, tantalum, platinum iridium alloy, platinum nickel alloy, platinum tungsten alloy, platinum tantalum alloy or gold.

In the multi-section balloon expandable stent system, the sheath size of the delivery system is selected from 4F-12F; the length of the conveying system is selected from 50-150 cm.

The beneficial effects of the invention are as follows:

the multi-section type balloon expandable stent-graft comprises a plurality of balloon expandable stent-grafts distributed along the axial direction and a conveying system capable of independently controlling release of each balloon expandable stent-graft. The multi-section balloon expandable stent graft can be specifically designed according to the specific conditions of the lesion area: the number, length, diameter, material, shape, interval, size of the conveying system and the like of the tectorial membrane stents can realize targeted treatment of different lesion areas. The delivery system capable of independently controlling the release of each balloon expandable stent can accurately release different stent at different lesion sites, thereby improving the safety of the operation. The multi-section structure is beneficial to improving the compliance of the balloon expandable stent system (compared with the balloon expandable stent system with the same total length of the stent and carrying a single stent), and can improve the in-vivo passing performance of the delivery system. The invention has the advantages that the invention can treat the blood vessel with longer lesion area or longer single lesion area or more tortuous lesion area under one interventional operation, simplify the operation, reduce the operation time and improve the treatment effect.

Drawings

FIG. 1 is a schematic view of an unexpanded overall structure according to an embodiment of the invention;

FIG. 2 is a schematic view of the overall structure of an expanded first embodiment of the present invention;

FIG. 3 is a schematic view of a released stent graft according to an embodiment of the present invention;

FIG. 4 is a schematic view of a balloon according to an embodiment of the present invention after inflation;

FIG. 5 is a schematic cross-sectional view of a delivery catheter according to a first embodiment of the present invention;

FIG. 6 is a schematic view of a non-expanded overall structure of a second embodiment of the present invention;

FIG. 7 is a schematic view of the overall structure of the second embodiment of the present invention after expansion;

fig. 8 is a schematic cross-sectional view of a second embodiment of a delivery catheter according to the present invention.

In the figure:

1: a ball-expanding tectorial membrane bracket; 1-1: a first stent graft; 1-2: a second stent graft; 1-3: a third stent graft; 1-4: coating a film; 1-5 metal bare stent; 2: a conveying system; 2-1: a balloon body; 2-1-1: a first balloon body; 2-1-2: a second balloon body; 2-1-3: a third balloon body; 2-2: a delivery catheter; 2-2-1: a first lumen; 2-2-2: a second lumen; 2-2-3: a third lumen; 2-2-4: a fourth lumen; 2-3: a delivery interface; 2-3-1: a first interface; 2-3-2: a second interface; 2-3-3: a third interface; 2-3-4: a fourth interface; 2-4: developing the mark; 2-4-1: a first developing mark; 2-4-2: a second developing mark; 2-4-3: and a third developing mark.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

Referring to fig. 1 to 8, the multi-section balloon expandable stent system comprises a plurality of balloon expandable stent 1 distributed along the axial direction and a conveying system 2 capable of independently controlling release of each balloon expandable stent; the ball-expanded covered stent 1 comprises a metal bare stent 1-5 and a covered stent 1-4; the delivery system includes a balloon body 2-1, a delivery catheter 2-2, a delivery interface 2-3, and a visualization mark 2-4 at the balloon body.

Example 1

Referring to fig. 1 to 5, the multi-section balloon expandable stent graft system of the present invention comprises a plurality of balloon expandable stent grafts 1 and a delivery system 2 capable of independently controlling release of each balloon expandable stent graft; the ball expansion tectorial membrane bracket comprises a metal bare bracket 1-5 and a tectorial membrane 1-4; the delivery system includes a balloon body 2-1, a delivery catheter 2-2, a delivery interface 2-3, and a visualization mark 2-4 located at the balloon body 2-1. The delivery interface 2-3 is connected to the proximal end of the delivery catheter 2-2. In fig. 1 and 2, the right side of the drawing is the proximal end and the left side is the distal end. The developing marks 2-4 comprise a first developing mark 2-4-1 and a second developing mark 2-4-2; the balloon body 2-1 includes a first balloon body 2-1-1 and a second balloon body 2-1-2.

In this embodiment, the number of balloon expandable stent grafts 1 is 2 segments. The diameter of the first covered stent 1-1 is 4mm, the length is 10mm, the material of the metal bare stent 1-5 is 316L stainless steel, and the covered material is expanded polytetrafluoroethylene. The shape of the main body section of the first saccule body 2-1-1 overlapped with the first tectorial membrane bracket 1-1 is cylindrical, and the material of the first saccule body 2-1-1 is PET. The first balloon body 2-1-1 is fixed to the delivery catheter 2-2 by means of heat welding, and the welded portions can form a sealed connection. The diameter of the second covered stent 1-2 is 5mm, the length is 12mm, the material of the metal bare stent 1-5 is 316L stainless steel, the material of the covered film 1-4 is a caprolactone lactate copolymer PLCL, and the covered film carries rapamycin. The shape of the main body section of the second saccule body 2-1-2 overlapped with the second tectorial membrane bracket 1-2 is cylindrical, and the material of the second saccule body 2-1-2 is PA. The second balloon body 2-1-2 is fixed to the delivery catheter 2-2 by means of heat welding, and the welded portions can form a sealed connection.

The delivery catheter 2-2 is a multi-lumen structure and has first, second and third lumens similar to the first, second and third lumens 2-2-1, 2-2-2 and 2-2-3, respectively, shown in fig. 4. These lumens of the delivery catheter 2-2 extend along the longitudinal axis of the catheter. The material of the developing marks 2-4 is platinum iridium alloy.

For the first covered stent 1-1, the second inner cavity 2-2-2 of the conveying catheter 2-2 is communicated with the corresponding inner space of the first balloon body 2-1-1, and the conveying catheter 2-2 in the first balloon body 2-1-1 is provided with a first developing mark 2-4-1. The second stent graft 1-2 is spaced from the first stent graft 1-1 by a distance determined by the distance between adjacent lesion sites. For the second tectorial membrane stent 1-2, the third inner cavity 2-2-3 of the delivery catheter 2-2 is communicated with the corresponding inner space of the second balloon body 2-1-2, and the delivery catheter 2-2 in the second balloon body 2-1-2 is provided with a second developing mark 2-4-2.

The proximal end of the delivery catheter 2-2 is sealingly connected to a delivery hub 2-3, the delivery hub 2-3 having a first hub 2-3-1, a second hub 2-3-2 and a third hub 2-3-3. The first port 2-3-1 is connected to a first lumen 2-2-1 of a delivery catheter 2-2 for surgical threading through a guidewire not shown in FIGS. 1, 2; the second interface 2-3-2 is communicated with a second inner cavity 2-2-2 of the conveying conduit 2-2; the third interface 2-3-3 is communicated with the third inner cavity 2-2-3 of the delivery catheter 2-2, and the second interface 2-3-2 and the third interface 2-3-3 are used for injecting liquid into the first saccule body 2-1-1 and the second saccule body 2-1-2 to pressurize during operation so as to release the first covered stent 1-1 and the second covered stent 1-2.

In the invention, the specific details of each balloon expandable stent can be selected in a certain range in advance before the operation, so that the targeted treatment of different lesion areas can be realized.

Example two

Referring to fig. 5 to 8, a multi-segment balloon expandable stent system according to a second embodiment of the present invention is different from the multi-segment balloon expandable stent system of the first embodiment in that: the multi-section balloon expandable stent graft system according to the second embodiment of the present invention comprises a 3-section balloon expandable stent graft 1, wherein the 3-section balloon expandable stent graft 1 comprises a first stent graft 1-1, a second stent graft 1-2 and a third stent graft 1-3 in this order from the distal end to the proximal end of a delivery catheter 2-2.

In accordance with the arrangement of the balloon expandable stent graft, the number of the inner cavities of the delivery catheter 2-2 is 4, and as shown in fig. 6, the 4 inner cavities are respectively a first inner cavity 2-2-1, a second inner cavity 2-2-2, a third inner cavity 2-2-3 and a fourth inner cavity 2-2-4. The transport interface 2-3 also has 4 interfaces, namely a first interface 2-3-1, a second interface 2-3-2, a third interface 2-3-3, and a fourth interface 2-3-4. Correspondingly, the number of different developing marks is 3, and a first developing mark 2-4-1 is arranged on a conveying catheter 2-2 in a first balloon body 2-1-1; a second developing mark 2-4-2 is arranged on a conveying catheter 2-2 in a second sacculus body 2-1-2; a third development mark 2-4-3 is provided on the delivery catheter 2-2 within the third balloon body 2-1-3, and the three sets of development marks 2-4 may be provided differently from each other in shape or size to enable knowledge of the exact location of the different balloon expandable stents during operation.

The method of operation of the multi-segment balloon stent system of the present invention will be described in detail below.

Taking the multi-section balloon expandable stent system in the first embodiment as an example: the method comprises the steps of firstly penetrating a guide wire into a target blood vessel to reach a lesion area, penetrating the guide wire from the top end of a conveying catheter 2-2 of a multi-section balloon expandable stent graft to a first inner cavity 2-2-1 as shown in fig. 5, then penetrating out of a first interface 2-3-1 of the conveying interface as shown in fig. 1, and pushing the conveying catheter 2-2 along the guide wire to push the first stent graft 1-1 to the corresponding vascular lesion area, wherein the position of the first stent graft 1-1 can be adjusted under digital subtraction angiography DSA through a developing ring. After the first covered stent 1-1 reaches the vascular lesion site, liquid is injected into the second interface 2-3-2 of the delivery interface 2-3, so that the first saccule body 2-1-1 and the first covered stent 1-1 pressed and held on the surface of the first saccule body are expanded under the action of pressure, then the liquid is pumped back through the second interface 2-3-2 of the delivery interface 2-3, so that the first saccule body 2-1-1 is in a negative pressure retraction state, and the first covered stent 1-1 is left at the vascular lesion site to expand a narrow blood vessel.

Continuing pushing the catheter 2-2, displaying the position of the second covered stent 1-2 by developing the mark under the DSA, injecting liquid into the third interface 2-3-3 of the delivery interface 2-3 after the second covered stent 1-2 reaches the vascular lesion site, expanding the second balloon 2-1-2 and the second covered stent 1-2 pressed on the surface of the second balloon under the action of pressure, and then pumping back the liquid through the third interface 2-3-3 of the delivery interface 2-3 to enable the second balloon 2-1-2 to be in a negative pressure retraction state, wherein the second covered stent 1-2 is left at the lesion site to expand the stenosed vessel. In addition, rapamycin medicine is loaded in the coating film of the second coating film bracket 1-2, and the medicine can be used for carrying out medicine administration treatment on the lesion area.

The foregoing description is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art, who is within the scope of the present invention, should make equivalent substitutions or modifications according to the technical solution of the present invention and the inventive concept thereof, and should be covered by the scope of the present invention.

Claims (9)

1. The multi-section type balloon expandable stent-graft system is characterized by comprising a plurality of balloon expandable stent-grafts (1) distributed along the axial direction and a conveying system (2) capable of independently controlling release of each balloon expandable stent-graft; the ball-expanded film-coated stent (1) comprises metal bare stents (1-5) and film-coated stents (1-4), wherein the number of the ball-expanded film-coated stents (1) is 2-5; the conveying system comprises a balloon body (2-1), conveying guide pipes (2-2), conveying interfaces (2-3) and developing marks (2-4) positioned at the balloon body, wherein the conveying guide pipes (2-2) are multi-cavity pipes, and the number of inner cavities is 3-6; the number of the conveying interfaces (2-3) is 3-6; the delivery hub (2-3) is connected to the proximal end of the delivery catheter (2-2), and one lumen of the delivery catheter (2-2) is in communication with only one of the delivery hubs (2-3).

2. The multi-section balloon expandable stent system according to claim 1, characterized in that the length of the balloon expandable stent (1) is 5-100 mm; the diameter of the ball-expanded tectorial membrane bracket (1) is 3-16 mm.

3. The multi-segment balloon expandable stent system according to claim 1, wherein the metallic bare stent (1-5) material of the balloon expandable stent (1) is selected from one of 316L stainless steel, cobalt chrome alloy.

4. The multi-segment balloon expandable stent graft system of claim 1, wherein the balloon expandable stent (1) comprises a drug loaded stent graft loaded with a drug and a blank stent graft not loaded with a drug; the medicine-carrying tectorial membrane bracket takes the tectorial membrane (1-4) as a carrier to carry medicine.

5. The multi-segment balloon expandable stent system of claim 4, wherein the drug is selected from one or more of rapamycin, rapamycin derivatives, paclitaxel derivatives, probucol, dexamethasone, aspirin, heparin, hirudin.

6. The multi-segment balloon expandable stent system according to claim 1, wherein the stent (1-4) material is selected from one or more of polylactic acid and its copolymers, polycaprolactone and its copolymers, polylactide and its copolymers, medical polydioxanone, polytrimethylene carbonate, polydioxanone, polyglycolic acid, silk fibroin, collagen, gelatin, polytetrafluoroethylene, polyurethane, polyester fabric, silk fabric.

7. The multi-segment balloon expandable stent system according to claim 1, wherein the balloon body (2-1) material is selected from one or more of nylon (PA), polyethylene terephthalate (PET), block polyether amide resin (PEBAX); the shape of the main body section of the balloon body (2-1) overlapped with the balloon expandable stent (1) is selected from a cylinder shape or a conical shape.

8. The multi-segment balloon stent graft system of claim 1, wherein the material of the development marks (2-4) is selected from one or more of platinum, tungsten, tantalum, platinum iridium alloy, platinum nickel alloy, platinum tungsten alloy, platinum tantalum alloy, or gold.

9. The multi-segment balloon expandable stent system of claim 1, wherein the sheath size of the delivery system is selected from the group consisting of 4F-12F; the length of the conveying system is selected from 50-150 cm.

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