CN114027938B - Auxiliary system and method for directional vertebral artery straddling eccentric plaque interventional operation - Google Patents

Auxiliary system and method for directional vertebral artery straddling eccentric plaque interventional operation Download PDF

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Publication number
CN114027938B
CN114027938B CN202111310377.3A CN202111310377A CN114027938B CN 114027938 B CN114027938 B CN 114027938B CN 202111310377 A CN202111310377 A CN 202111310377A CN 114027938 B CN114027938 B CN 114027938B
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balloon
cutting device
guide wire
plaque
cutting
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CN114027938A (en
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焦力群
杨斌
王亚冰
马妍
王韬
徐然
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Xuanwu Hospital
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Xuanwu Hospital
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    • A61B2017/22055—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with three or more balloons
    • A—HUMAN NECESSITIES
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    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • A—HUMAN NECESSITIES
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
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    • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
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    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract

The invention relates to an auxiliary system for directional vertebral artery straddling eccentric plaque interventional operation, which can tear plaque side intima more accurately, in particular to an auxiliary system for interventional operation on vertebral artery extending towards subclavian artery and only forming opening of straddling eccentric plaque on one side, at least comprising: a first balloon portion with a controllable form; the cutting device is arranged on the first balloon portion in an offset mode, so that at least the outer wall surface of the first balloon portion is divided into a cutting area and a protection area, and the cutting area can damage the surface of the plaque under the condition that the protection area corresponds to the non-pathological surface through a form changing mode.

Description

Auxiliary system and method for directional vertebral artery striding eccentric plaque interventional operation
Technical Field
The invention relates to the technical field of medical instruments, in particular to an auxiliary system and method for a directional vertebral artery straddling eccentric plaque interventional operation.
Background
Post-circulating ischemic stroke (TIA) accounts for 25-40% of stroke, 70% of post-circulating ischemic stroke is caused by vertebral artery-basal atheromatous plaque formation or arterial occlusion caused by an arterial dissection, the TIA has the characteristics of high morbidity, high mortality, high disability rate and high recurrence rate, and heavy burden is caused to families and society of patients. The origin of Vertebral Artery (VAO) is one of the most important causes of the occurrence of post-circulatory ischemia, because it is the most vulnerable site to atherosclerosis due to its hemodynamic disturbance. Studies have shown that 9% to 33% of patients with posterior ischemic disease have either a vertebral artery initial stenosis (VAOS) or occlusion. The annual incidence of post-circulating ischemia registration in New England is used to measure the VAOS-induced post-circulating ischemia patients of 1-2 ten thousand in the United states each year.
At present, drugs for treating vertebral atherosclerotic stenosis are mainly platelet aggregation resistant drugs, statin lipid lowering drugs and other drugs for controlling risk factors of cerebrovascular diseases, and the like, and can inhibit lipid metabolism, reduce lipid substance deposition and help stabilize plaques. When plaque develops to block the vertebral artery lumen, it causes stenosis of the vessel, and may even cause ischemia or necrosis of the tissue or organ. Interventional therapy is a common minimally invasive treatment means, and can effectively prevent stroke caused by vertebral artery stenosis. The interventional therapy mainly comprises a stent implantation operation and a saccule forming operation. The most important problem existing in the current interventional therapy is that the postoperative restenosis rate is very high, even if a novel drug eluting stent or a drug coating balloon is used, the restenosis rate after 1 year of operation is up to 15% -30%, and the effect of the interventional therapy is greatly reduced.
Drug-coated balloons such as that shown in fig. 2 are currently considered the safest and most effective treatment to minimize restenosis rates. When the drug coating saccule expands a narrow blood vessel, the intima of the blood vessel is slightly torn, and drugs on the saccule can enter the blood vessel wall through the breach of the intima, so that the purpose of inhibiting restenosis is achieved. For example, a prior art in patent publication No. CN106551737B proposes a protective sleeve for a drug-carrying device which can be disassembled in vivo, which comprises a proximal member, a distal member connected to the tail end of the proximal member, and a prefabricated tear line provided on the distal member. Because the last tear line of preprocessing that is equipped with of the distal end part of the medicine carrying instrument protective sheath that provides, accessible full sacculus pipe makes its inflation and breaks the tear line and causes distal end part in vivo disintegration, thereby makes medicine carrying instrument protective sheath and the medicine carrying instrument that carries realize the snap-off in vivo and withdraw from.
However, in the case of the opening stenosis of the vertebral artery caused by the Straddling Eccentric Plaque (Straddling Eccentric Plaque) which is usually close to one side of the blood vessel, since the other side of the blood vessel is the normal wall, the balloon such as the above-mentioned technical proposal applies pressure in the circumferential direction at the same time when expanding, so that the normal wall is also affected by the pressure of the balloon. Moreover, the toughness of the plaque side is higher than that of the normal side due to the existence of the plaque, so the endovascular film of the normal side is inevitably torn firstly when the balloon is expanded, and the tearing effect of the plaque side which needs to be treated is poor, the drug permeation is insufficient, and the effect of the drug coating balloon is greatly reduced. Based on this, a balloon device which can tear the plaque side intima more accurately is needed in clinic.
Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the applicant has studied a great deal of literature and patents when he or she made the present invention, but not limited to the details and contents listed in the section, this invention is by no means free of the features of the prior art, but instead the invention has been provided with all the features of the prior art, and the applicant has retained the right to increase the related art in the background.
Disclosure of Invention
The technical proposal of inhibiting restenosis is realized by expanding a blood vessel, tearing an inner vessel membrane and applying drugs, but the circumferential expansion mode of the device cannot solve the vertebral artery opening stenosis caused by a Straddling Eccentric Plaque (Straddling Eccentric Plaque) close to one side of the blood vessel. The lesion of the blood vessel where the striding eccentric plaque is located is concentrated on one side, and the other side is a normal vessel wall, but the balloon provided by the technical scheme can simultaneously apply pressure in the circumferential direction during expansion, so that the normal vessel wall is also influenced by the pressure of the balloon. Moreover, the toughness of the plaque side is higher than that of the normal side due to the existence of the plaque, so the endovascular film of the normal side is inevitably torn firstly when the balloon is expanded, and the tearing effect of the plaque side which needs to be treated is poor, the drug permeation is insufficient, and the effect of the drug coating balloon is greatly reduced. Based on this, the present application proposes an assistance system for directional vertebral artery astride eccentric plaque intervention operations, which allows a more precise tearing of the plaque-side intima, in particular for intervention operations on the vertebral artery, extending towards the subclavian artery and having only one side formed with the opening of the astride eccentric plaque, comprising at least: a first balloon portion with a controllable form; the cutting device is arranged on the first balloon portion in an offset mode, so that at least the outer wall surface of the first balloon portion is divided into a cutting area and a protection area, and the cutting area can damage the surface of the plaque under the condition that the protection area corresponds to the non-pathological surface through a form changing mode.
In this application, the cutting device is set up with the local region of its utricule with the mode of biasing on the sacculus portion that above-mentioned auxiliary system provided, and correspondingly, the utricule that does not set up cutting device on the sacculus portion forms the protection zone, consequently when driving about the sacculus expansion, can utilize the cutting device that is located sacculus portion to tear the endovascular film better rather than the pressure force tear, is favorable to the medicine infiltration vascular wall, suppresses the intimal hyperplasia, reduces the restenosis rate, prevents the emergence of cerebral apoplexy. Meanwhile, the protection area on the balloon part corresponds to the non-pathological surface in the blood vessel, and the acting force applied to the non-pathological surface when the balloon part expands is relieved. When in actual use, can select for use the cutting device of different specifications as required to be applicable to the blood vessel of different pipe diameters and the plaque of different scopes better. The cutting force, the cutting time and the like of the cutting device can be correspondingly adjusted by adjusting the internal pressure of the balloon part.
The application provides an auxiliary system of directional vertebral artery striding eccentric plaque intervention operation, at least comprising: a guide wire; and a first balloon portion with a controllable form, which is arranged on the guide wire, and is characterized in that a cutting device is arranged on the first balloon portion in an offset mode.
The application provides an auxiliary system of directional vertebral artery striding eccentric plaque intervention operation, at least comprising: the operation guide wire is provided with a first balloon part with controllable shape; the positioning guide wire is used for assisting the operation guide wire to position and is characterized in that a positioning channel used for being connected with the positioning guide wire is arranged on the first balloon portion, the operation guide wire can extend into a vertebral artery from a proximal subclavian artery, and the positioning guide wire can penetrate out of the positioning channel to enter a distal subclavian artery, so that the first balloon portion is positioned at the opening of the vertebral artery.
According to a preferred embodiment, the system further comprises an intervention sheath, a positioning guide wire and an operation guide wire, wherein the first balloon part is arranged on the operation guide wire, the positioning guide wire can enter a distal subclavian artery which is consistent with the extending direction of a proximal subclavian artery, and the operation guide wire can enter a vertebral artery which is different from the extending direction of the proximal subclavian artery.
According to a preferred embodiment, the cutting device comprises a plurality of wires, which are arranged side by side at intervals, and which are arranged on the wall surface of the first balloon portion in such a way that the direction of extension of the wires coincides with the direction of penetration of the vessel section when the first balloon portion enters the vessel section.
According to a preferred embodiment, the wire has a continuously varying width dimension in the height direction formed by the wire relative to the wall surface of the first balloon portion.
According to a preferred embodiment, the width dimension of the wire has a tendency to increase and then decrease in a direction extending outward from one end of the wire to the other end of the wire on the wall surface of the first balloon portion.
The application provides an auxiliary method for a directional vertebral artery striding eccentric plaque interventional operation, which is characterized by at least comprising the following steps of: connecting a positioning guide wire to the first balloon portion of the operating guide wire; moving the positioning guide wire and the operation guide wire to the opening of the vertebral artery; extending an operating guidewire from the proximal subclavian artery into the vertebral artery; the positioning guide wire can penetrate out of the positioning channel and enter the distal subclavian artery, so that the first balloon part is positioned at the opening of the vertebral artery.
According to a preferred embodiment, the system further comprises an intervention sheath, a positioning guide wire and an operation guide wire which are sleeved in the intervention sheath, the first balloon part is arranged on the operation guide wire, the intervention sheath is provided with a first guide hole which is arranged along the extension direction of the intervention sheath, and a second guide hole which is arranged on the tube wall and enables the opening direction to be different from the first guide hole, wherein when the positioning guide wire and the operation guide wire enter the proximal subclavian artery along with the intervention sheath and reach the bifurcation of the proximal subclavian artery, the positioning guide wire enters the distal subclavian artery which is consistent with the extension direction of the proximal subclavian artery in a mode that the positioning guide wire penetrates out of the first guide hole, the operation guide wire enters the vertebral artery which is different from the extension direction of the proximal subclavian artery in a mode that the positioning guide wire penetrates out of the second guide hole, and the guide wire section where the first balloon part is located corresponds to an opening which is arranged on the vertebral artery, extends towards the proximal subclavian artery and is internally provided with a striding eccentric plaque on one side.
This application improves the structure of interveneeing the sheath pipe and its intraductal reservation has the passageway that corresponds to location seal wire and operation seal wire respectively, and wherein the location seal wire can get into distal end subclavian artery through the passageway of reserving to the direction to the sacculus has been fixed a position, makes cutting device can accurately face plaque place face.
Preferably, the steering guidewire can be influenced by positioning an expanded balloon over the guidewire into the vertebral artery. After the positioning guide wire enters the distal subclavian artery, the balloon on the positioning guide wire is expanded to block the channel entering the distal subclavian artery, and the positioning guide wire only needs to enter the vertebral artery upwards when moving to the bifurcation.
According to a preferred embodiment, the cutting device comprises a plurality of wires, which are arranged side by side at intervals, and which are arranged on the wall surface of the first balloon portion in such a way that the direction of extension of the wires coincides with the direction of penetration of the vessel section when the first balloon portion enters the vessel section.
According to a preferred embodiment, the wire has a continuously varying width dimension in a height direction defined with respect to the wall surface of the first balloon portion, and the width dimension of the wire has a tendency to increase and then decrease in a direction extending outward from one end of the wire to the other end of the wire on the wall surface of the first balloon portion.
According to a preferred embodiment, the system further comprises a shape-controllable umbrella structure disposed on the operation guide wire, wherein the umbrella structure is configured to be received on the operation guide wire in a first folded state and can be converted to a unfolded state after the operation guide wire moves to a preset position in the vessel section.
According to a preferred embodiment, the cutting area of the first balloon portion is provided with a drug coating, the drug coating is coated on the wall surface of the first balloon portion so as to enable the first balloon portion to contact the damaged plaque surface under the condition that the cutting device cuts the damaged plaque surface, and the drug coating can include but is not limited to paclitaxel and rapamycin, or a combination of the paclitaxel and the rapamycin.
According to a preferred embodiment, the first balloon portion is expanded in a concave manner in a direction away from the straddling eccentric plaque under an eccentric expansion restriction of the first balloon portion in the direction of length extension of the operating guide wire by a cutting device having a certain expansion strength.
According to a preferred embodiment, the system further comprises a second balloon portion which is arranged on the operation guide wire and is closer to the far end of the guide wire than the first balloon portion, the first developing mark and the second developing mark are pre-configured on the first balloon portion or the second balloon portion, and the cutting position relation formed by the first balloon portion relative to the vertebral artery for assisting the cutting area of the first balloon portion and the plaque located face can be obtained by obtaining the developing position relation of the first developing mark and the second developing mark on a two-dimensional interface.
The application also provides an auxiliary method for the directional vertebral artery straddling eccentric plaque interventional operation, in particular to an auxiliary method for the interventional operation on the vertebral artery, which extends towards the subclavian artery and is only provided with an opening with the straddling eccentric plaque on one side, and the auxiliary method is characterized by at least comprising the following steps: leading the positioning guide wire and the operation guide wire to enter the proximal subclavian artery along with the intervention sheath tube and reach the bifurcation of the proximal subclavian artery; moving the positioning guide wire along a first guide hole of the intervention sheath so as to enable the positioning guide wire to enter a far-end subclavian artery consistent with the extending direction of a near-end subclavian artery; moving the operation guide wire along a second guide hole of the intervention sheath tube to enter a vertebral artery with the extending direction different from the extending direction of the proximal subclavian artery; the guide wire section where the first balloon part is located corresponds to an opening which is formed on one side in a cavity of the guide wire section, extends towards the proximal subclavian artery on the vertebral artery, and is provided with a striding eccentric plaque.
In the prior art, a cutting device usually cuts plaques by directly utilizing the expansion of a balloon, and for plaques with different shapes, the cutting device cannot ensure the cutting degree and the cutting area, so that the cutting operation is extremely easy to damage normal blood vessel walls. In addition, the thickness of the blood vessels of the vertebral artery and the subclavian artery is different, and when the cutting is performed according to the conventional cutting device, the balloons are uniformly expanded before and after the balloon is expanded, so that the balloons on one side can touch the plaque on the side, and the balloons on the other side can not touch the plaque, and a good cutting effect cannot be realized.
In view of the above, the present application proposes an assisting system and an assisting method for a striding eccentric plaque, which enable a cutting device to simulate a blood vessel wall in which the striding eccentric plaque is formed, and thereby enable a cutting degree of the cutting device and a cutting region thereof to be ensured when performing a cutting operation, the cutting degree being determined based on a displacement of the cutting device or an expansion degree of a balloon, and the cutting region being a humped striding eccentric plaque formed with respect to the blood vessel wall. The auxiliary system is particularly used for the interventional operation on the vertebral artery extending towards the subclavian artery and only forming an opening with a striding eccentric plaque on one side, and at least comprises: a first balloon portion with a controllable form; and a guide wire for guiding the first balloon portion to correspond to a cavity where the striding eccentric plaque is located, the cavity comprising a non-diseased surface and a plaque located surface which are sequentially formed along the circumferential direction of the cavity, and further comprising: the cutting device is arranged on the first balloon part in a controllable mode in an offset mode, at least the outer wall surface of the first balloon part is divided into a cutting area and a protection area, and the guide assembly is used for carrying out triggering events on the cutting device entering the cavity in the first mode so as to enable the cutting device to be converted into the second mode, so that the cutting device can damage the face where the plaque is located in the posture formed by the cutting device in the second mode under the condition that the cutting area corresponds to the face where the plaque is located by changing the shape of the first balloon part. Under this setting, on the one hand, the cutting device of different gestures can guide the inflation form of first sacculus portion, makes the shape of first sacculus portion can laminate more and ride the blood vessel cavity at astride nature eccentric plaque place, reaches better cutting effect. On the other hand, the cutting device can adaptively change the posture so as to meet the intervention requirements of different operation stages.
Drawings
FIG. 1 is a simplified schematic diagram of a preferred auxiliary system for directional vertebral artery straddle eccentric plaque interventional procedures;
fig. 2 is a schematic structural view of a conventional drug-coated balloon in a circumferential expansion type.
List of reference numerals
1: the vertebral artery; 2: a proximal subclavian artery; 3: the distal subclavian artery; 4: a first balloon portion; 5: operating a guide wire; 6: positioning a guide wire; 7: no diseased surface; 8: the surface of the plaque; 9: a cutting device; 10: cutting the area; 11: a protection area; 12: inserting a sheath; 13: a striding eccentric plaque; 100: a drug-coated balloon.
Detailed Description
The following detailed description is made with reference to the accompanying drawings.
Reference herein to a Straddling Plaque (Straddling Eccentric Plaque) or atherosclerotic Plaque at the opening of a vertebral artery, and in particular to a Straddling Plaque at the opening of a vertebral artery, or other lesion whose anatomical structure resembles the opening of a vertebral artery. Atherosclerotic plaques at the vertebral artery openings are different from conventional lesions existing on the inner wall of blood vessels, the most common position of atherosclerosis of the vertebral artery 1 is at the vertebral artery openings, namely the openings of the vertebral artery 1 extending towards the subclavian artery, the openings are of a bifurcation structure rather than a conventional strip structure, and the straddling plaques usually cross over the vertebral artery 1 and the subclavian artery, so that the technical schemes which are applied to atherosclerotic plaques in a large amount in the prior art cannot be applied to the straddling plaques. Furthermore, the straddling plaque usually accumulates on the inner side of the opening of the vertebral artery, while the outer side is usually the normal non-diseased intima, and the solutions applied in a large number in the prior art to atherosclerotic plaque all cause pressure on the blood vessel from the periphery, cause unexpected damage to the normal non-diseased intima, and even cause restenosis after interventional treatment of the opening stenosis of the vertebral artery.
The application provides an auxiliary system for directional vertebral artery straddling eccentric plaque intervention operation, in particular for the intervention operation on the vertebral artery extending towards subclavian artery and having only one side formed with opening of straddling eccentric plaque.
For the sake of understanding, the location and connection between the vertebral artery 1 and the subclavian artery will be described first, and the vertebral artery 1 starts from the upper wall of the first segment of the subclavian artery and extends generally upward along the cervical spine after exiting. The subclavian artery can be divided into a proximal subclavian artery 2 and a distal subclavian artery 3 from the location of the junction between the vertebral artery 1 and the subclavian artery. The proximal subclavian artery 2, the distal subclavian artery 3 and the vertebral artery 1 form a three-way bifurcation with each other. The guidewire can be placed from the proximal subclavian artery 2 and moved into the vertebral artery 1 or into the distal subclavian artery 3. The straddling eccentric plaque 13 is usually located at the corner of the vertebral artery ostium that extends toward the vertebral artery 1 along the proximal subclavian artery 2.
In the present application, the cavity formed by the bifurcation structures is referred to as a lumen or a blood vessel lumen, and the inner wall surface of the portion of the lumen where the striding eccentric plaque 13 is formed is the plaque-located surface 8, and correspondingly, the inner wall surface opposite to the plaque-located surface 8 is the non-diseased surface 7. The plaque-bearing surface 8 is relative to the non-diseased surface 7 and does not absolutely refer to a fixed wall surface within the cavity.
As shown in fig. 1, the system includes a first balloon portion 4 and an operating guide wire 5, the first balloon portion 4 being positioned on the operating guide wire 5.
The first balloon portion 4 has a cavity and its form is controllable. The first balloon portion 4 can be expanded or contracted by injecting or discharging a fluid into or from the cavity of the first balloon portion 4. The fluid may be a gas or a liquid.
The first balloon portion 4 can be placed in a blood vessel together with the operation wire 5 and moved to a specified position corresponding to the plaque to be treated. Whether the first balloon portion 4 is located at a specified position or not can be determined by angiography. The designated position is the position of the plaque to be processed.
The operation guide wire 5 is in a strip-shaped structure and is mainly used for leading the first balloon part 4 in a contraction state to be close to the cavity where the striding eccentric plaque 13 is located.
A cutting device 9 is arranged on the first balloon portion 4 to better destroy the plaque to be treated, replacing the traditional technical scheme of forcedly tearing the plaque by means of the pressure formed by balloon inflation.
The cutting means 9 are not arranged around the circumference of the first balloon portion 4 but only on a partial region of the first balloon portion 4. I.e. the cutting means 9 is arranged in an offset manner on the first balloon portion 4.
With this arrangement, the outer wall surface of the first balloon portion 4 is divided into the cut region 10 and the protection region 11. The cutting area 10 is the area of the first balloon portion 4 covered by the cutting device 9. The protection region 11 may be a region on the other side of the first balloon portion 4 opposite to the side where the cutting region 10 is located.
When the first balloon portion 4 is placed in the cavity, the protection area 11 of the first balloon portion 4 corresponds to the non-diseased surface 7 and the cutting area 10 corresponds to the plaque-located surface 8, and the first balloon portion 4 is expanded so that the cutting area 10 is close to the plaque-located surface 8 and cuts the plaque located at that position. On the other side of the first balloon portion 4, the protection area 11 is in contact with the non-diseased surface 7, due to the arrangement of the cutting device 9, the first balloon portion 4 can cut the plaque under a relatively small expansion degree, the protection area 11 does not apply excessive pressure on the non-diseased surface 7, and therefore the protection effect on the non-diseased surface 7 is achieved.
Preferably, in actual use, the cutting device 9 with different specifications can be preset according to requirements so as to be better suitable for blood vessels with different tube diameters and plaques in different ranges.
Preferably, by adjusting the internal pressure of the balloon portion, the cutting force, the cutting time and the like of the cutting device 9 can be adjusted correspondingly.
Preferably, the wall surface of the first balloon portion 4 corresponding to the protection zone 11 is provided with flexible villous protrusions. The flexible villiated protrusions form a barrier over the protective region 11 to prevent the first balloon portion 4 from acting directly on the normal intima of the blood vessel, further enhancing the protective effect on the normal intima of the blood vessel.
The system further comprises an interventional sheath 12 and a positioning guidewire 6. The positioning guide wire 6 and the operation guide wire 5 can be sleeved inside the intervention sheath 12. At the beginning of the interventional procedure, the positioning guidewire 6 and the operation guidewire 5 can be moved together with the interventional sheath 12 into the interior of the blood vessel.
The intervention sheath 12 and the positioning guide wire 6 can be both in a strip-shaped structure, and the guide wire 5 can be operated in an auxiliary way to better intervene in the vertebral artery 1.
Preferably, two juxtaposed cavities may be provided within the interventional sheath 12 for the positioning guidewire 6 and the manipulation guidewire 5, respectively. Preferably, the positioning guide wire 6 and the operation guide wire 5 can also be co-located in a lumen of the interventional sheath 12.
The positioning guide wire 6 and the operation guide wire 5 can respectively penetrate through the intervention sheath 12 and can respectively move in the blood vessel without mutual influence.
Preferably, the intervention sheath 12 is provided with a first guide hole and a second guide hole. The first guide hole is opened along the extending direction of the tube body of the intervention sheath tube 12. The second guiding hole is opened on the wall of the intervention sheath 12 and the opening direction of the second guiding hole is different from that of the first guiding hole.
Preferably, the second guide hole is also opened along the extending direction of the tube body of the intervening sheath tube 12, but the opening direction thereof is different from the first guide hole.
The positioning guide wire 6 and the operation guide wire 5 enter the proximal subclavian artery 2 along with the intervention sheath 12. When the end of the interventional sheath 12 reaches the bifurcation of the proximal subclavian artery 2, the positioning guide wire 6 is passed out of the first guide hole and into the distal subclavian artery 3 in accordance with the extending direction of the proximal subclavian artery 2. The positioning guidewire 6 is kept in the current position, where positioning may be achieved by inflating a balloon structure on the positioning guidewire 6.
And (3) penetrating the operation guide wire 5 out of the second guide hole and into the vertebral artery 1, so that the guide wire section provided with the first balloon part 4 on the operation guide wire 5 is positioned at the opening of the vertebral artery 1, and the first balloon part 4 corresponds to the position of the plaque.
In a preferred embodiment, the first balloon portion 4 is provided with a positioning channel, and the positioning guide wire 6 is placed in the intervention sheath 12 together with the operation guide wire 5 in such a manner that the positioning guide wire penetrates through the positioning channel. The end of the intervention sheath 12 is only provided with a first guide hole, the first guide hole is formed along the extension direction of the intervention sheath 12, and when the end of the intervention sheath 12 reaches the bifurcation of the proximal subclavian artery 2, the positioning guide wire 6 and the operation guide wire 5 penetrate out of the first guide hole. The positioning guidewire 6 is manipulated to extend along the positioning channel toward the distal subclavian artery 3. The guide wire 5 is manipulated to extend into the vertebral artery 1. Therefore, a bifurcation structure is formed between the positioning guide wire 6 and the operation guide wire 5, so that the first balloon portion 4 can be well positioned to the opening of the vertebral artery 1.
Wherein, the positioning channel is arranged on the outer wall of the first balloon part 4 and is not communicated with the inside of the balloon body. The positioning channel is provided at one end of the first balloon portion 4. When the balloon is not inflated, the positioning channel may extend through along the operation guide wire 5, and the extension length of the positioning channel is smaller than that of the first balloon portion 4.
Preferably, the guide wire section of the operation guide wire 5 corresponding to the first balloon portion 4 has a certain rigidity, and is set in advance in a slightly curved posture. Because the guide wire section is continuously connected with other guide wire sections front and back, the bending of the guide wire section can not influence the implantation process or the inner wall of the blood vessel.
Preferably, the cutting means 9 may be several wires. A plurality of wires are juxtaposed at intervals on the wall surface of the first balloon portion 4. The extending direction of the wire coincides with the extending direction of the operating guide wire 5. The cutting device 9 performs a cutting operation on the plaque by means of the restriction of the expansion of the first balloon portion 4 inside the blood vessel, and the degree of cutting can be adjusted by adjusting the degree of expansion of the first balloon portion 4.
Preferably, the wire has a continuously varying width dimension in a height direction formed perpendicular to the wall surface of the first balloon portion 4. Preferably, the width dimension of the wire has a tendency to increase first and then decrease in a direction in which the wire extends outward from one end thereof on the wall surface of the first balloon portion 4 to the other end.
Preferably, when the first balloon portion 4 is expanded to the preset expansion posture, a central angle of a coverage area defined by positions of two outermost wires of the plurality of wires juxtaposed to each other in the circumferential direction of the first balloon portion 4 is between 90 ° and 120 °.
Preferably, the first balloon portion 4 is positioned on the operation guide wire 5 in such a manner that the whole body thereof can rotate relative to the operation guide wire 5, so that the cutting positional relationship thereof formed relative to the vertebral artery 1 satisfies a preset cutting positional relationship. The relative rotation of the first balloon portion 4 may be achieved by a micro motor.
Preferably, the first balloon portion 4 and the second balloon portion may be in a linked relationship. The relative rotation of the first balloon portion 4 can drive the second balloon portion to rotate synchronously. After the first balloon portion 4 is rotated, secondary positioning is performed by the second balloon portion, and it is determined whether the first balloon portion 4 is rotated in place.
Preferably, the system further comprises a protective umbrella structure. The protective umbrella structure is arranged on the operation guide wire 5. The shape of the protective umbrella structure is controllable, and the protective umbrella structure can be switched between a folding state and an unfolding state. The protective umbrella structure is accommodated on the operation guide wire 5 in a first folded state, so that the operation guide wire 5 can be smoothly placed in. After the operation guide wire 5 is moved to a preset position in the blood vessel section, the umbrella structure is switched to the unfolded state.
The umbrella structure can capture the striding eccentric plaque 13 which enters blood after being loosened in the unfolding state, and the captured striding eccentric plaque 13 is taken out of the body along with the withdrawing of the guide wire by the umbrella structure in a mode of retracting from the unfolding state to the first folding state. Due to the morphological change of the umbrella structure behind the capture of the straddling eccentric plaque 13, it will be switched from the unfolded state to the first folded state without capture of the straddling eccentric plaque 13 or the second folded state with capture of the straddling eccentric plaque 13.
Preferably, the cut region 10 of the first balloon portion 4 is provided with a drug coating. When the cutting means 9 cuts the side 8 of the destroyed plaque, the drug coating will come into contact with the side 8 of the destroyed plaque.
Preferably, the drug coating may include, but is not limited to, one or a combination of two of paclitaxel, rapamycin.
The wire has a certain elongation strength, i.e. it has a certain resistance to deformation. In contrast, the first balloon portion 4 has less resistance to deformation on the side where the wire is not provided. In this arrangement, the first balloon portion 4 is inflated in a non-uniform manner and is formed to be recessed inwardly towards the cutting zone 10 where the wire is located. Preferably, the cutting device 9 forms an eccentric expansion restriction of the first balloon portion 4 in the direction of the length extension of the operating wire 5, so that the first balloon portion 4 expands in a direction away from the straddling eccentric plaque 13. The expanded first balloon portion 4 is recessed inward.
The system also includes a second balloon portion. The second balloon portion is arranged on the operation guide wire 5, and the second balloon portion is closer to the distal end of the guide wire relative to the first balloon portion 4. Reference in this application to the distal end of a guidewire may refer to the end that is threaded into a blood vessel. The second balloon portion is mainly used to assist the positioning of the first balloon portion 4 within the vessel.
Preferably, the second balloon portion is provided with a first developing mark and a second developing mark in advance. The cutting position relation of the first balloon portion 4 relative to the vertebral artery 1 for assisting the cutting area 10 of the first balloon portion 4 and the face 8 where the plaque is located can be obtained by acquiring the developing position relation of the first developing mark and the second developing mark on the two-dimensional interface. The visualization position relationship on the two-dimensional interface referred to in the present application may refer to a position relationship between the first visualization marker and the second visualization marker in a picture obtained by contrast.
The second balloon portion enters the vessel segment in a contracted posture and is convertible to a preset first expanded posture so that the first visualization marker and the second visualization marker can be recognized. Preferably, the first developing mark extends continuously in the circumferential direction of the second balloon portion with a constant distance from both ends of the second balloon portion. Preferably, the second developing marks extend continuously along the circumferential direction of the second balloon portion, and the distance between the second developing marks and the two ends of the second balloon portion has a changing trend. Preferably, the first development marks may be arranged in a manner similar to a hoop belt, and the second development marks may be arranged in a manner similar to a spiral belt. With this arrangement, the first and second development marks differ in their spacing, as viewed at different positions in the circumferential direction of the second balloon portion, which can be obtained by the development positional relationship of the first and second development marks with respect to each other on the two-dimensional interface.
Preferably, the inner wall of the balloon portion is provided with a through channel, and the through channel can form a first developing mark and a second developing mark on the inner wall of the balloon portion by introducing a developer to fill the through channel. The through passage includes a first through passage and a second through passage connected to each other, the first through passage extending along an annular shape of the second balloon portion, the second through passage extending spirally upward around a circumferential direction of the second balloon portion.
Preferably, the first and second development marks may be provided in a manner of being applied to the outer side or inner wall of the balloon portion in advance.
The application also provides an auxiliary method of the directional vertebral artery straddling eccentric plaque interventional operation, in particular to an auxiliary method of the interventional operation on an opening which extends towards the subclavian artery on the vertebral artery 1 and is only formed with the straddling eccentric plaque 13 on one side. When the intervention operation is performed, the positioning guide wire 6 and the operation guide wire 5 enter the proximal subclavian artery 2 along with the intervention sheath 12 to reach the bifurcation of the proximal subclavian artery 2. The positioning guidewire 6 is moved along the first guide hole of the access sheath 12 into the distal subclavian artery 3 in line with the extension of the proximal subclavian artery 2. The operation guide wire 5 is moved along the second guide hole of the intervention sheath 12 into the vertebral artery 1 extending in a direction different from the direction in which the proximal subclavian artery 2 extends. The guide wire section of the first saccule part 4 corresponds to the opening of the vertebral artery 1, which extends towards the proximal subclavian artery 2 and is internally provided with a striding eccentric plaque 13 on one side. The first balloon portion 4 is expanded and the cutting device 9 on the first balloon portion 4 performs a cutting disruption on the plaque.
In a preferred embodiment, the cutting device 9 is controllable in form, the cutting device 9 having at least a first form and a second form. The first and second configurations of the cutting device 9 may refer to flexibility and rigidity, respectively. The form of the cutting device 9 is controllable, i.e. the cutting device 9 can be switched between flexible and rigid without affecting its use.
The controllable form of the first balloon portion 4 may be such that the first balloon portion 4 is switched between inflation and deflation by charging and discharging fluid into the cavity of the first balloon portion 4.
The cutting device 9 in the first configuration has a certain flexibility for a more smooth placement of the guide wire into the vessel section or for extending between different vessel sections. The cutting device 9 in the second configuration has a certain rigidity for forming an effective cutting action on the striding eccentric plaque 13.
The assistance system of the present application further comprises a guiding assembly for performing a triggering event on the cutting device 9 entering the cavity in the first configuration to cause the cutting device 9 to switch to the second configuration.
By changing the form of the first balloon portion 4, the cut region 10 can be made to correspond to the plaque-located surface 8. The cutting device 9 is capable of disrupting the plaque-bearing surface 8 in the position it has formed in the second state.
The attitude of the cutting device 9 formed in the second configuration refers to a certain attitude which it forms in the first configuration by the action of an external force and which is fixed by its transformation to the second configuration. The attitude of the cutting device 9 in the second configuration may be made different by different external forces. The external force referred to herein may refer to the force exerted on the cutting device 9 by the operation of the guide wire 5. In particular, the cutting device 9 in the first configuration may be adapted to change as the configuration of the operating wire 5 changes.
Under this setting, on the one hand, the cutting device 9 of different gestures can guide the inflation form of first sacculus portion 4, makes the shape of first sacculus portion 4 can more laminate the vascular cavity that strides eccentric plaque 13 and be located, reaches better cutting effect. On the other hand, the cutting device 9 itself can be adapted to perform posture changes to meet the intervention requirements of different surgical stages.
Preferably, the cutting means 9 may comprise several strips, which are all provided on the outer wall of the first balloon portion 4. The strip-shaped portion has a width dimension that continuously changes in a height direction formed perpendicular to the wall surface of the first balloon portion 4. The strip-shaped portion may be of a triangular prism shape, one end face of which is a quadrangle located on the outer wall of the first balloon portion 4, and the other two end faces of which, adjacent to the end face, are a quadrangle forming cutting faces for cutting plaque. For convenience of understanding, the end surface of the bar-shaped portion on the outer wall of the first balloon portion 4 is taken as a bottom surface, the other two end surfaces of the bar-shaped portion adjacent to the end surface and in a quadrilateral shape are taken as a first side surface and a second side surface, and the end surfaces of the bar-shaped portion at the two ends in the length extending direction are taken as a first end surface and a second end surface. The bottom surface, the first side surface, the second side surface, the first end surface and the second end surface jointly surround to form a cavity in the strip-shaped part.
Preferably, the cavity of the bar is filled with a thermotropic phase change composite material, so that the change of form of the cutting device 9 can be controlled by temperature. In this arrangement, the guiding element is a heat-conducting element and is arranged in the cavity of the bar, which is used to perform a triggering event on the cutting device 9 entering the cavity in the first configuration, i.e. a change in temperature, to switch the cutting device 9 to the second configuration. The guide component can be a strip-shaped flexible heating wire, the deformation capacity of the guide wire is not affected, and the guide component can heat after being electrified, so that the shape of the thermotropic phase change composite material filled in the cavity of the strip-shaped part is changed. Preferably, the thermotropic phase change composite may be a composite composed of high latent heat Paraffin (PA), Olefin Block Copolymer (OBC), Expanded Graphite (EG). Wherein, PA is used as PCM for absorbing heat, OBC is used as a supporting material, and EG is used for improving heat conduction performance. When the PA is below the phase transition temperature, the PA is in a solid phase crystallization state, and the molecular chain segment of the OBC soft segment is frozen. As the temperature increases, the PA changes from a solid to a liquid state and the molecular segments of the soft segments of the OBC are "thawed" and free to move. Meanwhile, the existence of the liquid phase PA can play a role in lubrication in the movement of the chain segment, so that the storage modulus is rapidly reduced, and the material obtains flexibility. Good flexibility can be obtained by triggering the phase change of the PA, so that various deformation modes such as bending and compression are obtained. When the external stress for deforming the material is cancelled, the molecular chain of the soft segment gradually reaches a thermodynamic equilibrium state under the action of entropy elasticity, and the macroscopic expression is the shape recovery. Preferably, each end face of the strip may be made of a thermally insulating material to avoid that temperature variations within the strip have a detrimental effect on the blood vessel.
Preferably, the cavities of the bar are filled with a magneto-rheological composite material, so that the change in form of the cutting device 9 can be controlled by a magnetic field. In this arrangement, the guiding element is a current conductor and is arranged in the cavity of the bar-shaped portion for performing a triggering event on the cutting device 9 entering the cavity in the first configuration to switch the cutting device 9 to the second configuration, the triggering event being a change in the magnetic field. The guide assembly can be a strip-shaped flexible electrified conductor, deformation capacity of the guide wire is not affected, and the guide assembly can generate a magnetic field after being electrified so that the form of the magnetic phase change material filled in the cavity of the strip-shaped portion is changed. Preferably, the magneto-rheological material may be a magneto-rheological fluid which exhibits low viscosity newtonian fluid characteristics in the absence of an external magnetic field. Magnetorheological fluids are typically suspensions of micron-sized or nano-sized ferromagnetic particles (typically carbonyl iron particles) immersed in a non-magnetic carrier liquid, with small amounts of other auxiliary solutions. Exhibits high viscosity, low flow Binghamton fluid (Binghamton) upon application of a magnetic field. The viscosity of the liquid is corresponding to the magnetic flux. This conversion is low in energy consumption, easy to control, and fast in response (milliseconds). Preferably, each end face of the bar portion may be made of an insulating material. As a preferred embodiment, the guiding assembly may also be an extra-corporeal magnetic field applying assembly, which is located outside the body near the surgical site and which is energized to create a magnetic field which covers the cutting device 9 located inside the body. In this arrangement, the guide assembly is not disposed on the guidewire but is external to the body to effect the triggering event.
Preferably, the cavities of the bar are filled with a photo-induced phase change material, so that the change in form of the cutting device 9 can be controlled by light. In this arrangement, the guiding member is a light emitting member and is disposed in the cavity of the bar-shaped portion, and is configured to perform a triggering event on the cutting device 9 entering the cavity in the first form, so as to switch the cutting device 9 to the second form, where the triggering event is a change in light intensity. The guide assembly can be a long flexible transparent optical fiber, deformation capacity of the guide wire is not affected, and the guide assembly can emit light after being electrified, so that the shape of the photoinduced phase change material filled in the cavity of the strip-shaped portion is changed. Preferably, the light-induced phase change material can change the structure thereof according to light with different wavelengths, and can be changed from a rigid substance to a soft substance. The photo-phase change material may be composed of a polymer attached to photosensitive molecules that can alter chemical bonds formed within the material. When a magnetic field is present in the fluid, the magnetic particles align in chains along the magnetic field lines, increasing the stiffness of the fluid and thus simultaneously the overall structure. When the magnetic field is removed, the fluid behaves as a liquid, being able to flow freely.
Preferably, the cavities of the bar are filled with an electrically-responsive phase change material, so that the change in form of the cutting device 9 can be controlled by an electrical signal. In this arrangement, the guiding element is an electrical conductor and is arranged in the cavity of the strip-shaped portion, which is used to perform a triggering event on the cutting device 9 entering the cavity in the first configuration, so as to switch the cutting device 9 to the second configuration, the triggering event being a change in the electrical signal. The guide assembly can be a strip-shaped electric conductor, deformation capacity of the guide wire is not affected, and the guide assembly can transmit an electric signal to the electric signal phase change material after being electrified, so that the form of the electric signal phase change material filled in the cavity of the strip-shaped part is changed. Preferably, the phase change material can change the strength of the material in a few seconds, and the whole quality change process is controlled by the electric signal. The phase change material caused by electric signals can be a metal and liquid mixed material formed by putting a noble metal material such as gold or platinum into an acid solution for corrosion, forming tiny pipelines and holes in the material, then pouring a nano-structure material into the whole pore channel frame, and simultaneously filling each micropore with a conductive liquid. The electric signal induced phase change material can be called as metal water conjunct, and can be excited by an electric signal to rapidly change the material form. Preferably, in the presence of an external current, atomic bonds on the surface of the metal are strengthened, and the hardness of the material is increased; when the current is cut off, atomic bonds are weakened, and the material can also become softer, has stronger damage resistance and better ductility. The mechanical property of the phase-change material caused by the electric signal can be switched back and forth between a soft state and a hard state. Preferably, each end face of the bar may be made of an insulating material.
To achieve a better cutting effect, the system further comprises a second balloon portion and a third balloon portion. The second balloon portion and the third balloon portion are both arranged on the guide wire, and can assist the cutting device 9 in forming a posture required in the operation.
An auxiliary method for directional vertebral artery straddling eccentric plaque intervention operation at least comprises the following steps: after the operation guide wire 5 is placed into the vertebral artery 1, the cutting device 9 in the first state forms a preset posture under the condition that the guide wire sections positioned at two sides of the first balloon portion 4 are respectively positioned into the blood vessel sections by changing the states of the second balloon portion and the third balloon portion.
Preferably, a second balloon portion is provided on the operating guide wire 5, and the second balloon portion can enter the vertebral artery 1 along with the operating guide wire 5. The third balloon portion is arranged on the interventional sheath 12, and the third balloon portion can enter the subclavian artery along with the interventional sheath 12. The second balloon portion and the third balloon portion each enter the blood vessel in a contracted position, and each have a lumen that is expandable upon injection of a fluid.
Preferably, the third balloon portion includes an inner balloon forming a channel for passage of the guide wire and an outer balloon sleeved on the outside of the inner balloon. When fluid is injected between the inner saccule and the outer saccule, the inner saccule contracts inwards under the action of pressure, the guide wire is relatively fixed in the intervention sheath 12 by the third saccule part, and the guide wire cannot slide relative to the intervention sheath 12 at the moment.
After the operation guide wire 5 is placed into the vertebral artery 1, the second balloon portion and the third balloon portion are respectively located on both sides of the first balloon portion 4. Under this setting, the second balloon portion and the third balloon portion are respectively expanded to abut against the blood vessel wall by changing the shapes thereof, thereby forming two positioning points on the operation guide wire 5.
The first balloon portion 4 is located on the wire guide section between the second and third balloon portions. Due to the greater deformability of the cutting device 9 in the first configuration, the guide wire section between the second and third balloon portions is relatively positioned within the vessel section when two positioning points are formed on the operating guide wire 5, so that the guide wire section is bent in a manner simulating the corner position between the proximal subclavian artery 2 and the vertebral artery 1. At the same time, the cutting device 9 on the guide wire section also forms a posture corresponding to the blood vessel section where the plaque is located.
In order to make the guide wire segment better simulate the corner position between the proximal subclavian artery 2 and the vertebral artery 1, the second balloon part and the third balloon part are respectively expanded in a manner that the second balloon part and the third balloon part are respectively perpendicular to the radial direction of the operation guide wire 5 or the intervention sheath 12 so that the operation guide wire 5 or the intervention sheath 12 is inserted in the central area of the expanded second balloon part or the expanded third balloon part. Preferably, the outer wall of the intervention sheath 12 or the operation guide wire 5 where the second and third balloon portions are located is provided with a positioning ring in advance, so as to better match the guide wire segment to the blood vessel wall formed with the straddling eccentric plaque 13.
To ensure the effectiveness of the plaque cutting operation, after the cutting device 9 in the first configuration has been brought into the preset attitude, the cutting device 9 is able to destroy the plaque surface 8 in the attitude it has been brought into in the second configuration, by switching the cutting device 9 into the second configuration, in the case where the cutting area 10 corresponds to the plaque surface 8. The posture formed in the second form here may also be the posture formed in the first form. Since the cutting device 9 in the second state has a certain resistance against deformation, the cutting device 9 is enabled to cut the straddle-type eccentric plaque 13 in a manner simulating the shape of a blood vessel wall. In the prior art, the cutting device 9 usually cuts the plaque directly by means of the expansion of the balloon, and for plaques with different shapes, the cutting device 9 cannot ensure the cutting degree and the cutting area 10, so that the cutting operation is very easy to damage the normal blood vessel wall. In addition, the vertebral artery 1 and the subclavian artery have different blood vessel thicknesses, and if the cutting is performed by the conventional cutting device 9, one balloon may touch the plaque before and after the inflation of the balloon, and the other balloon does not touch the plaque, so that a good cutting effect cannot be realized. In contrast, the present application proposes a system and a method for assisting a straddling eccentric plaque 13, which can simulate a blood vessel wall on which the straddling eccentric plaque 13 is formed by the cutting device 9, and can ensure the cutting degree of the cutting device 9 and the cutting region 10 thereof when performing a cutting operation, wherein the cutting degree can be determined based on the displacement of the cutting device 9 or the expansion degree of the balloon, and the cutting region 10 is the raised straddling eccentric plaque 13 formed on the blood vessel wall.
In order to achieve a better cutting effect, the second balloon portion and the third balloon portion may be both of a combined balloon structure. A modular balloon structure is herein meant to comprise two balloon sections. The two balloon sections are located on opposite sides of the guide wire or interventional sheath 12, respectively, and the expansion of the two sections is separately controlled. By simultaneously expanding the two balloon sections, the cutting device 9 can be brought into a position simulating the vessel wall. By expanding one of the balloon sections and deflating the other balloon section, the cutting device 9 is moved towards the side of the deflated balloon section, cutting the plaque. Preferably, the first balloon portion 4 is in accordance with the regulation of the balloon portion on the third balloon portion to avoid accidental injury of the normal vessel wall by the cutting device 9. Preferably, for the plaque with stronger bias in the direction extending from the proximal subclavian artery 2 to the vertebral artery 1, that is, the plaque on one side of the proximal subclavian artery 2 or vertebral artery 1 is more accumulated than the plaque on the other side, better cutting operation can be realized by asynchronously regulating and controlling the balloon sections on the first balloon section 4 and the third balloon section.
It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not limiting upon the claims. The scope of the invention is defined by the claims and their equivalents. The present description contains several inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally", each indicating that the respective paragraph discloses a separate concept, the applicant reserves the right to submit divisional applications according to each inventive concept. Throughout this document, the features referred to as "preferably" are only optional and should not be understood as necessarily requiring that such applicant reserves the right to disclaim or delete any relevant preferred feature at any time.

Claims (5)

1. An assistance system for directional vertebral artery straddle eccentric plaque intervention procedures, comprising:
a first balloon portion (4) with a controllable form; and
a guide wire for guiding the first balloon part (4) to correspond to a cavity where the striding eccentric plaque (13) is located, the cavity comprises a non-pathological surface (7) and a plaque located surface (8) which are sequentially formed along the circumferential direction of the cavity,
it is characterized in that the preparation method is characterized in that,
the first balloon part (4) is provided with a cutting device (9) in an offset mode, so that the outer wall surface of the first balloon part (4) is divided into a cutting area (10) and a protection area (11), wherein the first balloon part (4) can enable the cutting area (10) to damage the surface (8) where the plaque is located under the condition that the protection area (11) corresponds to the non-pathological surface (7) in a mode of changing the shape,
the cutting device (9) comprises a plurality of strip-shaped parts, the strip-shaped parts are arranged on the outer wall of the first balloon part (4), the strip-shaped parts have continuously changing width sizes in the height direction formed by the wall surface perpendicular to the first balloon part (4), one end surface of each strip-shaped part is quadrangular and is positioned on the outer wall of the first balloon part (4), and the other two end surfaces adjacent to the end surface and being quadrangular form cutting surfaces for cutting plaques, wherein,
the cavity of the bar-shaped part is filled with a thermotropic phase change composite material so as to control the form change of the cutting device (9) through temperature, wherein the guide component is a heat-conducting component and is arranged in the cavity of the bar-shaped part and used for implementing a trigger event on the cutting device (9) entering the cavity in a first form so as to enable the cutting device (9) to be converted into a second form, and the trigger event is the change of the temperature.
2. An assistance system for directional vertebral artery straddle eccentric plaque intervention procedures, comprising:
a guide wire; and
a first balloon portion (4) with a controllable shape, which is arranged on the guide wire,
it is characterized in that the preparation method is characterized in that,
the first balloon portion (4) is provided with a cutting device (9) in an offset manner,
the cutting device (9) comprises a plurality of strip-shaped parts, the strip-shaped parts are arranged on the outer wall of the first balloon part (4), the strip-shaped parts have continuously changing width sizes in the height direction formed by the wall surface perpendicular to the first balloon part (4), one end surface of each strip-shaped part is quadrangular and is positioned on the outer wall of the first balloon part (4), and the other two end surfaces adjacent to the end surface and being quadrangular form cutting surfaces for cutting plaques, wherein,
the cavity of the bar-shaped part is filled with a magneto-induced phase change composite material so as to control the form change of the cutting device (9) through a magnetic field, wherein the guide component is a power-on conductor and is arranged in the cavity of the bar-shaped part, and the guide component is used for implementing a trigger event on the cutting device (9) entering the cavity in a first form so as to enable the cutting device (9) to be converted into a second form, and the trigger event is the change of the magnetic field.
3. An assistance system for directional vertebral artery straddle eccentric plaque intervention procedures, comprising:
the operation guide wire is provided with a first balloon part (4) with controllable shape;
a positioning guide wire for assisting the operation of the guide wire for positioning,
it is characterized in that the preparation method is characterized in that,
the first balloon part (4) is provided with a positioning channel for connecting a positioning guide wire, the operation guide wire can extend from the proximal subclavian artery to enter the vertebral artery, the positioning guide wire can penetrate out of the positioning channel to enter the distal subclavian artery, so that the first balloon part (4) is positioned at the opening of the vertebral artery,
the first balloon portion (4) is provided with a cutting device (9) in an offset mode, the cutting device (9) comprises a plurality of strip-shaped portions, the strip-shaped portions are arranged on the outer wall of the first balloon portion (4), the strip-shaped portions have continuously-changed width sizes in the height direction perpendicular to the wall surface of the first balloon portion (4), one end face of each strip-shaped portion, which is quadrangular, is located on the outer wall of the first balloon portion (4), and the other two end faces, which are adjacent to the end face and are quadrangular, form cutting faces for cutting plaques, wherein the cutting faces are arranged on the outer wall of the first balloon portion (4),
the cavity of the bar-shaped part is filled with a photoinduced phase change material so as to control the form change of the cutting device (9) through light, wherein the guide assembly is a light-emitting part and is arranged in the cavity of the bar-shaped part, and the guide assembly is used for implementing a trigger event on the cutting device (9) entering the cavity in a first form so as to enable the cutting device (9) to be converted into a second form, and the trigger event is the change of light intensity.
4. The system according to claim 1 or 2, further comprising an interventional sheath (12), a positioning guide wire (6) and an operating guide wire (5), the first balloon portion (4) being provided on the operating guide wire (5), wherein the positioning guide wire (6) is accessible to the distal subclavian artery (3) in line with the extension of the proximal subclavian artery (2) and the operating guide wire (5) is accessible to the vertebral artery (1) in line with the extension of the proximal subclavian artery (2).
5. An assistance system for directional vertebral artery straddle eccentric plaque intervention procedures, comprising:
a first balloon portion (4) with a controllable form; and
a guide wire for guiding the first balloon part (4) to correspond to a cavity where the striding eccentric plaque (13) is located, the cavity comprises a non-pathological surface (7) and a plaque located surface (8) which are sequentially formed along the circumferential direction of the cavity,
it is characterized by also comprising:
a cutting device (9) which is controllable in shape and is arranged on the first balloon portion (4) in a biased manner so that the outer wall surface of the first balloon portion (4) is divided into a cutting area (10) and a protection area (11),
a guide assembly for effecting a triggering event to the cutting device (9) entering the cavity in the first configuration to transition the cutting device (9) to the second configuration such that the cutting device (9) is able to disrupt the plaque surface (8) in the attitude it assumes in the second configuration in the event that the cutting region (10) corresponds to the plaque surface (8) by altering the configuration of the first balloon portion (4),
the cutting device (9) comprises a plurality of strip-shaped parts, the strip-shaped parts are arranged on the outer wall of the first balloon part (4), the strip-shaped parts have continuously changing width sizes in the height direction formed by the wall surface perpendicular to the first balloon part (4), one end surface of each strip-shaped part is quadrangular and is positioned on the outer wall of the first balloon part (4), and the other two end surfaces adjacent to the end surface and being quadrangular form cutting surfaces for cutting plaques, wherein,
the cavity of the bar-shaped part is filled with an electric signal phase-change material so as to control the form change of the cutting device (9) through an electric signal, wherein the guide assembly is an electric conductor and is arranged in the cavity of the bar-shaped part and used for executing a trigger event on the cutting device (9) entering the cavity in the first form so as to convert the cutting device (9) into the second form, and the trigger event is the change of the electric signal.
CN202111310377.3A 2021-11-05 2021-11-05 Auxiliary system and method for directional vertebral artery straddling eccentric plaque interventional operation Active CN114027938B (en)

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CN202211366421.7A CN115634012B (en) 2021-11-05 2021-11-05 Cutting device for directional vertebral artery interventional operation auxiliary system
CN202111310377.3A CN114027938B (en) 2021-11-05 2021-11-05 Auxiliary system and method for directional vertebral artery straddling eccentric plaque interventional operation

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