CN114081579A - Mechanical thrombus taking device for cerebral apoplexy and application thereof - Google Patents

Mechanical thrombus taking device for cerebral apoplexy and application thereof Download PDF

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CN114081579A
CN114081579A CN202111429850.XA CN202111429850A CN114081579A CN 114081579 A CN114081579 A CN 114081579A CN 202111429850 A CN202111429850 A CN 202111429850A CN 114081579 A CN114081579 A CN 114081579A
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catheter
stent
thrombus
long sheath
guide wire
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CN202111429850.XA
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张全斌
周晓宇
刘学源
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Shanghai Tenth Peoples Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22001Angioplasty, e.g. PCTA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22038Implements 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 a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22072Implements 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 instrument channel, e.g. for replacing one instrument by the other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22079Implements 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 suction of debris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22094Implements 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 for crossing total occlusions, i.e. piercing

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  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Surgical Instruments (AREA)
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Abstract

The invention relates to a mechanical thrombus taking device for cerebral apoplexy and application thereof, wherein the device consists of a 6F long sheath of 90 cm, a 6F middle catheter and a 6X30 Solitaire FR thrombus taking bracket. The device combines the bracket embolectomy and catheter suction technologies, and has the advantages that: (1) the success rate of the operation is high, and particularly the one-time three-level opening rate is high, so that the opening time is shortened, the operation-related complications are reduced, and the clinical prognosis is obviously improved. (2) The used materials are simple, the cost is saved, and the device is adopted to remove the embolus, so that the average operation consumable is 4 to 5 ten thousand yuan, which is greatly lower than the cost of other operation modes, thereby having economic significance. (3) The used materials are simplified and standardized, the operation process is programmed, the operation process is very easy to master and popularize, in addition, the difficulty of the technology can be further reduced along with the continuous release of new appliances, and the method has good application prospect.

Description

Mechanical thrombus taking device for cerebral apoplexy and application thereof
Technical Field
The invention relates to the technical field of cerebral apoplexy mechanical thrombus removal devices and application thereof, in particular to a cerebral apoplexy mechanical thrombus removal device and application thereof.
Background
Stroke is one of the major diseases causing death and disability in humans. The incidence of stroke in China rises year by year, and national stroke screening data show that the incidence of the first stroke bid of a 40-74 year old resident rises year by year, and the average annual increase is 8.3%. In addition, in the stroke attack population of China, the proportion of patients with the age of less than 70 years is continuously increased, and the trend of the patients is younger. At present, stroke has become the first cause of death in our country. Ischemic stroke accounts for 70% of the total in new patients. Therefore, the level of treatment of Acute Ischemic Stroke (AIS) is related to the health of residents in China.
The cerebral arterial thrombosis caused by the acute cerebral ischemic stroke due to the occlusion of the large blood vessel can restore the cerebral blood flow by a mechanical embolectomy mode, improve the nerve function and remarkably benefit patients, so the cerebral arterial thrombosis is considered as the milestone progress of neuroscience for nearly 20 years. The basic technical modes of current embolectomy include two types, stent embolectomy and catheter aspiration. Among them, Stent Retrieval (SR) embolization has been established as a standard of care for large vessel occlusive acute ischemic stroke.
However, in clinical practice, we find that the total success rate of the single stent thrombus removal and the single catheter suction is only about 70-80%, the one-time opening rate is less than 40%, and the repeated thrombus removal operation or the remedial measures delay the opening time and increase complications such as bleeding, blood vessel dissection, thrombus escape and the like, so that the clinical prognosis of a patient is poor.
The Chinese patent application: CN202010104470.8 discloses a local thrombolysis thrombus extraction device suitable for venous thrombolysis contraindication and its use method. The device comprises a main duct, wherein the two ends of the main duct are respectively a front end and a rear end, the rear end is provided with a plurality of interfaces, and the front end is closed; the main catheter is provided with a thrombolysis section, two ends of the thrombolysis section are respectively provided with a plurality of balloons, the thrombolysis section is provided with a plurality of thrombolysis channel openings, and the balloons are respectively communicated with one interface through balloon lumens; a small circulation tube cavity inlet is arranged between the thrombolysis section and the rear end of the main catheter, and a small circulation tube cavity outlet is arranged between the thrombolysis section and the front end; the inlet of the small circulation lumen is communicated with the outlet of the small circulation lumen through a blood flow lumen inside the main catheter; the openings of the plurality of thrombolysis channels are respectively communicated with one interface through a thrombolysis tube cavity in the main tube. By establishing local thrombolysis circulation, thrombus is gradually dissolved and taken away, and secondary tissue damage and even death caused by thrombus fragmentation and falling to flow to downstream capillary vessels are avoided.
The Chinese patent application: cn201980088158.x discloses a thrombectomy system and method for extracting thrombi. A thrombectomy system comprising: a delivery catheter; an aspiration catheter including an aspiration funnel configured to be movably disposed within the delivery catheter in a retracted position and at least partially disposed outside the delivery catheter in an extended and expanded position, the funnel including an impermeable cover, the funnel configured to adapt its shape and length to a surrounding blood vessel such that the funnel reduces blood flow through the blood vessel and lengthens as it narrows to retain thrombus within the funnel; a clot capture element configured to capture thrombus and to be at least partially withdrawn into the funnel with the captured thrombus; and a microcatheter adapted to carry the clot capture element to the thrombus. The clot capture element is movably disposed within the microcatheter in a retracted position. The micro-catheter is movably disposed within the suction catheter.
However, we have found that either stent embolization alone or catheter aspiration alone is used in the prior art. The invention innovatively discovers for the first time that the two are combined, the result can obtain the effect of '1 +1> 2', and the one-time opening rate and the clinical prognosis of a patient are both obviously improved. The mechanical thrombus extraction device for cerebral apoplexy and the application thereof are not reported at present.
Disclosure of Invention
The invention aims to provide a mechanical thrombus removal device for stroke and application thereof, aiming at the defects of the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that:
in a first aspect, the invention provides a mechanical stroke embolectomy device, which consists of a 6F 90 cm long sheath, a 6F intermediate catheter and a 6X30 Solitaire FR embolectomy stent.
Preferably, the use method of the device comprises the following steps:
(1) femoral artery puncture is carried out, a long sheath of 6F 90 cm, a VTK catheter of 5F and a hard guide wire of a point 35 are combined, the long sheath is sent to a responsible blood vessel, and a primary treatment path is established; delivering the 6F intermediate catheter to a higher position to establish a secondary treatment pathway; the micro-catheter is super-selected to be far away from the thrombus occlusion point under the micro-guide wire guide tube shaped by the pigtail, and the Solitaire FR stent is released;
(2) under the coaxial technique, the 6F long sheath is as high as possible so as to enhance the external support of the 6F middle catheter; a hard guide wire of a built-in point 18 of the 6F middle catheter is used as an inner support, and then the 6F middle catheter is sent to the intracranial section of the responsible vessel by utilizing the anchoring effect of the stent and directly contacts the thrombus;
(3) in a negative pressure suction state, firstly, pulling the stent, then continuously sucking the middle catheter for 1-2 minutes, withdrawing the middle catheter, and sucking the long sheath to finish the whole thrombus removal operation;
(4) obtaining the product.
Preferably, the culprit vessel in step (1) is a carotid or vertebral artery.
In a second aspect, the invention provides the use of a device as described above in mechanical embolectomy of stroke.
Further, the present invention provides the use of a device as described above for reducing complications of bleeding, vascular dissection, and thrombus escape.
In a third aspect, the invention provides a mechanical thrombus removal method for cerebral apoplexy for non-diagnosis or non-treatment purposes, wherein the method uses a device which is as follows: consisting of a 90 cm long 6F sheath, a 6F intermediate catheter and a 6X30 Solitaire FR thrombectomy stent.
Further, the method comprises the steps of:
(1) femoral artery puncture is carried out, a long sheath of 6F 90 cm, a VTK catheter of 5F and a hard guide wire of a point 35 are combined, the long sheath is sent to a responsible blood vessel, and a primary treatment path is established; delivering the intermediate catheter to a higher position to establish a secondary treatment pathway; the micro catheter is super-selected to be far away from the thrombus occlusion point under a micro guide wire guide tube shaped by a pigtail, and the stent is released;
(2) under the coaxial technique, the 6F long sheath is as high as possible so as to enhance the external support of the 6F intermediate catheter; a hard guide wire of a built-in point 18 of the 6F middle catheter is used as an inner support, and then the 6F middle catheter is sent to the intracranial section of the responsible vessel by utilizing the anchoring effect of the stent and directly contacts the thrombus;
(3) in a negative pressure suction state, firstly, pulling the stent, then continuously sucking the middle catheter for 1-2 minutes, withdrawing the middle catheter, and sucking the long sheath to finish the whole thrombus removal operation;
(4) obtaining the product.
Preferably, the culprit vessel in step (1) is a carotid or vertebral artery.
Preferably, the method is a combination of stent embolectomy and catheter aspiration.
The invention has the advantages that:
1. the success rate of the operation is high, and particularly the one-time three-level opening rate is high, so that the opening time is shortened, the operation-related complications are reduced, and the clinical prognosis is obviously improved.
2. The used materials are simple, the cost is saved, and the mechanical device for embolectomy has the average operation consumable of 4 to 5 ten thousand yuan, which is greatly lower than the cost of other operation modes, thereby having economic significance.
3. The used materials are simplified and standardized, the operation process is programmed, the operation process is very easy to master and popularize, and in addition, the difficulty of the technology can be further reduced along with the continuous push-out of new appliances.
4. Compared with the method for taking thrombus by using a pure bracket, the method has the following obvious advantages: when the mechanical stent is used for mechanical thrombus removal, the middle suction catheter directly contacts thrombus, and when the stent is used for mechanical thrombus removal, the middle suction catheter is not stressed to contact the thrombus, so that the stent is safer and more efficient than the stent.
5. Compared with a pure catheter suction plug, the suction plug has the following advantages: the suction of the invention is the suction under the expansion and anchoring of the stent, and compared with the pure catheter suction, the suction has the following advantages: (1) the stent anchors the thrombus, so that the risk of falling and escaping of the thrombus can be prevented or remarkably reduced; (2) after the stent is unfolded, thrombus can be cut, so that the effect of sucking the thrombus by the catheter is improved; (3) the stent is deployed in the blood vessel cavity and the suction catheter, so that the blood vessel cavity and the suction catheter can be prevented from collapsing under negative pressure suction, and the suction effect can be ensured. Thus, stent-assisted aspiration is more efficient, safer, and thus, the device of the present invention has a synergistic effect.
Drawings
FIG. 1 is a stent embolectomy drawing, with FIG. A being a standard stent embolectomy and FIG. B being a stent embolectomy of the present invention.
Fig. 2A is a simple catheter aspiration and fig. 2B is an aspiration under the stent anchoring and cutting thrombus of the present invention.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.
Example 1 apparatus construction
Consisting of a 90 cm long 6F sheath, a 6F intermediate catheter and a 6X30 Solitaire FR thrombectomy stent.
Example 2 method of use
The method comprises the following steps:
(1) femoral artery puncture, namely, a long sheath of 6F 90 cm, a VTK catheter of 5F and a hard guide wire of a point 35 are combined to deliver the long sheath to a responsible vessel (carotid artery or vertebral artery) to establish a primary treatment path; delivering the intermediate catheter to a higher position to establish a secondary treatment pathway; the micro catheter is super-selected to be far away from the thrombus occlusion point under a micro guide wire guide tube shaped by a pigtail, and the stent is released;
(2) under the coaxial technology, the long sheath of 6F is as high as possible, so that the external support of the 6F middle catheter is enhanced to the maximum extent; a hard guide wire of a built-in point 18 of the 6F middle catheter is used as an inner support, and then the 6F middle catheter is sent to the intracranial section of the responsible vessel by utilizing the anchoring effect of the stent and directly contacts the thrombus;
(3) in the negative pressure suction state, firstly, stent thrombus is pulled, then the middle catheter is continuously sucked for 1 to 2 minutes, the middle catheter is withdrawn, the long sheath is also sucked, and the whole thrombus removal operation is completed.
(4) If the opening is obtained, the operation can be ended, and if the opening is not successfully completed, the operation is repeated.
Example 3 application
1 method
Patients who underwent mechanical embolectomy with circulating occlusion before 2016 to 2019 in month 1 were selected as subjects.
Among them, 97 patients used SR thrombectomy, and 81 patients used example 2 thrombectomy.
2 results
See the following Table
TABLE 1
Figure BDA0003379867490000051
Figure BDA0003379867490000061
3 conclusion
The result shows that the blood vessel recanalization rate of the invention is superior to that of SR embolectomy, excessive equipment channels are avoided, operation-related complications are reduced, and the procedure time is shortened.
The reasons why the present invention helps to overcome vascular tortuosity and difficult anatomical conditions are:
(1) advancing the 6F long sheath catheter to as high a position as possible to maximize external support to the 6F intermediate catheter;
(2) a 0.018 inch stiff guidewire was placed directly into the 6F intermediate catheter, obtaining an inner support;
(3) stronger anchoring effect can be obtained by selecting Solitaire FR scaffolds with longer and larger sizes;
if the femoral artery access is difficult to perform the blood vessel over-selection on the aortic arch, the carotid artery or the radial artery is punctured. Intra-operative thrombus escape is one of the major problems with mechanical embolectomy, and the use of balloon catheters (BGCs) to reduce this complication is strongly recommended by many experts. In the present invention, a 6F long sheath catheter is sufficiently high in most cases, and introduction of a 6F intermediate catheter into an intracranial vessel effectively blocks antegrade blood flow, which in effect mimics the effects of BGC. The deep placement of the 6F long sheath catheter and the 6Fr intermediate catheter also raises safety concerns. However, in our case series, the present invention had no procedure-related vascular lesions, whereas 40 patients in the SR group developed such lesions (0% versus 4.1%). Here we consider the coaxial advancement technique to prevent vascular injury. In addition, in the procedure of the present invention, the thrombectomy stent is very close to the intermediate catheter tube, and therefore, the damage to the vessel during the stent pullback process is also minimized. In conclusion, compared with the pure stent embolectomy technology, the invention has the advantages of vessel recanalization and comparable clinical results.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these should also be considered as the protection scope of the present invention.

Claims (9)

1. A mechanical thrombus removal device for cerebral apoplexy is characterized by consisting of a 6F long sheath of 90 cm, a 6F middle catheter and a 6X30 Solitaire FR thrombus removal support.
2. The device of claim 1, wherein the method of using the device comprises the steps of:
(1) femoral artery puncture is carried out, a long sheath of 6F 90 cm, a VTK catheter of 5F and a hard guide wire of a point 35 are combined, the long sheath is sent to a responsible blood vessel, and a primary treatment path is established; delivering the 6F intermediate catheter to a higher position to establish a secondary treatment pathway; the micro-catheter is super-selected to be far away from the thrombus occlusion point under the micro-guide wire guide tube shaped by the pigtail, and the Solitaire FR stent is released;
(2) under the coaxial technique, the long sheath is as high as possible to enhance the external support of the 6F intermediate catheter; a hard guide wire of a built-in point 18 of the 6F middle catheter is used as an inner support, and then the 6F middle catheter is sent to the intracranial section of the responsible vessel by utilizing the anchoring effect of the stent and directly contacts the thrombus;
(3) in a negative pressure suction state, firstly, pulling the stent, then continuously sucking the middle catheter for 1-2 minutes, withdrawing the middle catheter, and sucking the long sheath to finish the whole thrombus removal operation;
(4) obtaining the product.
3. The device of claim 2, wherein the culprit vessel in step (1) is a carotid or vertebral artery.
4. Use of the device of any one of claims 1-3 for mechanical embolectomy in stroke.
5. Use of a device according to any of claims 1-3 for reducing complications of bleeding, vascular dissection, and thrombus escape.
6. A mechanical thrombus removal method for cerebral apoplexy for non-diagnosis or non-treatment purposes, which is characterized in that the method uses the following devices: consisting of a 90 cm long 6F sheath, a 6F intermediate catheter and a 6X30 Solitaire FR thrombectomy stent.
7. A mechanical stroke embolectomy method for non-diagnostic or non-therapeutic purposes, comprising the steps of:
(1) femoral artery puncture is carried out, a long sheath of 6F 90 cm, a VTK catheter of 5F and a hard guide wire of a point 35 are combined, the long sheath is sent to a responsible blood vessel, and a primary treatment path is established; delivering the 6F intermediate catheter to a higher position to establish a secondary treatment pathway; the micro-catheter is super-selected to be far away from the thrombus occlusion point under the micro-guide wire guide tube shaped by the pigtail, and the Solitaire FR stent is released;
(2) under the coaxial technique, the 6F long sheath is as high as possible so as to enhance the external support of the 6F intermediate catheter; a hard guide wire of a built-in point 18 of the 6F middle catheter is used as an inner support, and then the 6F middle catheter is sent to the intracranial section of the responsible vessel by utilizing the anchoring effect of the stent and directly contacts the thrombus;
(3) in a negative pressure suction state, firstly, pulling the stent, then continuously sucking the middle catheter for 1-2 minutes, withdrawing the middle catheter, and sucking the long sheath to finish the whole thrombus removal operation;
(4) obtaining the product.
8. The method of claim 7, wherein the culprit vessel in step (1) is a carotid or vertebral artery.
9. The method of claim 7, wherein the method is a combination stent embolectomy and catheter aspiration.
CN202111429850.XA 2021-11-29 2021-11-29 Mechanical thrombus taking device for cerebral apoplexy and application thereof Pending CN114081579A (en)

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CN108742776A (en) * 2018-08-15 2018-11-06 王鹏 A kind of Manual negative pressure suction combined bracket, which takes, ties system
CN113423348A (en) * 2018-11-13 2021-09-21 阿纳康达生物医学有限公司 Thrombectomy system and method for extracting thrombus from a thrombus site in a patient's blood vessel
CN112057133A (en) * 2020-09-15 2020-12-11 玮铭医疗器械(上海)有限公司 Multifunctional treatment catheter
CN112494104A (en) * 2020-12-15 2021-03-16 上海融脉医疗科技有限公司 Be used for endovascular thrombus suction catheter device and basket subassembly thereof

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Title
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李桂林 等: "Solitaire FR支架机械取栓联合5F Navien导管抽吸技术治疗大脑中动脉急性闭塞的效果分析", 《中国脑血管病杂志》, vol. 14, no. 1, pages 38 *
袁磊 等: "Solitaire支架取栓联合Neuro导管抽吸对颅内大动脉急性闭塞患者血管再通率及远端栓塞事件发生率的影响", 《中国医学工程》, vol. 28, no. 4, pages 66 *
邱玉发 等: "县级综合卒中中心应用Solitaire支架机械取栓联合Navien导管抽吸技术治疗急性前循环大血管闭塞的效果分析", 《中国脑血管病杂志》, vol. 16, no. 12, pages 639 *

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Application publication date: 20220225