WO2024109274A1 - 斑块治疗装置 - Google Patents

斑块治疗装置 Download PDF

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Publication number
WO2024109274A1
WO2024109274A1 PCT/CN2023/118460 CN2023118460W WO2024109274A1 WO 2024109274 A1 WO2024109274 A1 WO 2024109274A1 CN 2023118460 W CN2023118460 W CN 2023118460W WO 2024109274 A1 WO2024109274 A1 WO 2024109274A1
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WO
WIPO (PCT)
Prior art keywords
plaque
catheter
driving
slider
treatment device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2023/118460
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English (en)
French (fr)
Inventor
束宇婷
周奇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Microport Medical Group Co Ltd
Original Assignee
Shanghai Microport Medical Group Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Microport Medical Group Co Ltd filed Critical Shanghai Microport Medical Group Co Ltd
Priority to EP23893367.5A priority Critical patent/EP4623843A4/en
Publication of WO2024109274A1 publication Critical patent/WO2024109274A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A61B2017/22074—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22081—Treatment of vulnerable plaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320064—Surgical cutting instruments with tissue or sample retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • A61F2/014—Retrograde blood flow filters, i.e. device inserted against the blood flow direction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0092—Single injection needle protruding laterally from the distal tip

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a plaque treatment device.
  • Vulnerable plaques are also called unstable plaques, soft plaques, high-risk plaques, etc. They refer to unstable high-risk plaques in atherosclerotic plaques that are rapidly prone to thrombosis.
  • the characteristics of this type of plaque are that the fibrous cap is thin and the lipid core is large, which makes it very easy to rupture, poor stability, and prone to acute cardiovascular and cerebrovascular events.
  • the degree of stenosis in some patients is not serious (less than 50%), but because it is a vulnerable plaque, acute cardiovascular and cerebrovascular events such as myocardial infarction, cardiac arrest, acute cerebral infarction, etc. may occur at any time.
  • Clinically, 75% of acute myocardial infarctions are caused by the rupture of vulnerable plaques, which seriously affects people's living standards.
  • statins to enhance lipid-lowering
  • other drugs such as: anticoagulants and antiplatelet drugs reduce local inflammatory reactions in arteries and inhibit thrombosis after plaque rupture; GPIIb/IIIa antagonists and heparin (UFH) not only improve perfusion levels but also reduce the degree of embolism after use; calcium ion antagonists delay the progression of coronary atherosclerosis and other drugs can play a certain role in the treatment of vulnerable plaques.
  • these drug treatments have problems such as slow onset, long treatment cycle, and unreliable efficacy.
  • the object of the present invention is to provide a plaque treatment device to solve the problem that vulnerable plaques are currently mainly treated by drugs.
  • the present invention provides a plaque treatment device, which includes: a catheter, a plaque destruction mechanism and a content recovery mechanism; the plaque destruction mechanism is configured to switch between an execution state and a first storage state;
  • the plaque destroying mechanism in the first storage state is loaded on the catheter and is used to move with the catheter; the plaque destroying mechanism in the execution state is used to destroy the target The wall of the plaque, and the content recovery mechanism is used to recover the contents of the target plaque.
  • the plaque treatment device also includes a driving mechanism; the driving mechanism is used to drive the plaque destruction mechanism to switch between the execution state and the first storage state; the plaque destruction mechanism includes a sharp portion connected to the driving mechanism, and when the plaque destruction mechanism switches from the first storage state to the execution state, the sharp portion extends radially relative to the catheter to puncture the wall of the target plaque.
  • the driving mechanism includes a slider and a connecting rod, one end of the connecting rod is connected to the slider, and the other end of the connecting rod is connected to the plaque destruction mechanism; the slider is used to move along the axial direction of the catheter to drive the plaque destruction mechanism to switch between the execution state and the first storage state through the connecting rod.
  • the driving mechanism includes a slider accommodating cavity and a driving fluid channel arranged along the axial direction of the catheter, the radial outer contour shape of the slider is adapted to the radial inner contour shape of the slider accommodating cavity, and the slider is movably arranged in the slider accommodating cavity along the axial direction; the driving fluid channel is connected to the slider accommodating cavity, and the driving fluid channel is used to inject the driving fluid into the slider accommodating cavity, or to absorb the driving fluid from the slider accommodating cavity, so as to drive the slider to move axially.
  • the driving mechanism includes a threaded driving member arranged along the axial direction of the catheter, the slider is threadedly connected to the threaded driving member, and the threaded driving member is used for self-rotation to drive the slider to move along the axial direction.
  • the driving mechanism includes two sliders arranged axially at intervals and at least two connecting rods; each of the sliders is connected to at least one of the connecting rods; and the two sliders are configured to move synchronously in opposite directions.
  • the plaque destruction mechanism includes an extension base arranged outside the catheter, the extension base extends along the axial direction of the catheter, the sharp portion is arranged on the extension base, the extension base is connected to the other end of the connecting rod, and the extension base is used to move radially under the drive of the connecting rod; wherein, when the plaque destruction mechanism is in the first storage state, the extension base is abutted against the outer wall of the catheter; when the plaque destruction mechanism is in the execution state, the extension base moves radially away from the catheter and is used to squeeze the wall of the target plaque.
  • the plaque treatment device also includes a driving mechanism; the driving mechanism is used to drive the plaque destruction mechanism to switch between the execution state and the first storage state; the plaque destruction mechanism includes a sharp portion connected to the driving mechanism; the driving mechanism includes a driving wire and a guide member, and the driving wire is connected to the sharp portion; the guide member is used to guide and change the extension direction of the driving wire; wherein, when the plaque destruction mechanism is in the first storage state, the sharp portion does not extend beyond the guide member and the catheter, whichever is closer to the outside; when the plaque destruction mechanism switches from the first storage state to the execution state, the sharp portion, driven by the driving wire, extends out of the guide member and the catheter in a direction angled to the axial direction of the catheter, so as to puncture the wall of the target plaque.
  • the driving mechanism is used to drive the plaque destruction mechanism to switch between the execution state and the first storage state
  • the plaque destruction mechanism includes a sharp portion connected to the driving mechanism
  • the driving mechanism includes a driving wire and a guide member, and the driving wire is connected to
  • the guide member includes an arc-shaped extending guide tube segment, the proximal end of the guide tube segment tangentially extends along the axial direction of the catheter, and the distal end of the guide tube segment tangentially extends at an angle to the axial direction of the catheter and penetrates the outer wall of the catheter; the guide tube segment is used for allowing the drive wire to movably pass through, and for guiding and changing the extension direction of the drive wire.
  • the content recovery mechanism comprises a blocking member, the blocking member has selective permeability, and allows a size of no more than a portion of the content to pass through; the blocking member is configured to switch between a blocking state and a second storage state;
  • the blocking member When the blocking member is in the blocking state, it is used to block the downstream side of the target plaque to collect the contents with a size larger than the permeable size;
  • the blocking member When the blocking member is in the second storage state, the blocking member is loaded on the catheter and is used to move with the catheter;
  • the blocking member when the blocking member is converted from the blocking state to the second receiving state, the collected contents are prevented from escaping from the blocking member.
  • the plaque destruction mechanism includes a sharp portion
  • the content recovery mechanism includes a recovery hole opened on the sharp portion along the axial direction of the sharp portion, and also includes a recovery channel extending along the axial direction of the catheter, and the recovery hole is connected to the recovery channel; the recovery channel and the recovery hole are used for sucking out the contents of the target plaque.
  • the content recovery mechanism further comprises a plurality of side branch holes, the side branch holes being opened on the side wall of the sharp portion along the radial direction of the sharp portion and being connected to the recovery hole; The contents of the target plaque are allowed to pass through.
  • the catheter is a multi-lumen tube.
  • the plaque treatment device includes a catheter, a plaque destruction mechanism and a content recovery mechanism; the plaque destruction mechanism is configured to switch between an execution state and a first storage state; wherein the plaque destruction mechanism in the first storage state is loaded on the catheter and is used to move with the catheter; the plaque destruction mechanism in the execution state is used to destroy the wall of the target plaque, and the content recovery mechanism is used to recover the contents of the target plaque.
  • the plaque destruction mechanism can be used to physically destroy the wall of the target plaque, and then the contents of the target plaque can be recovered by the content recovery mechanism without causing harm with blood circulation.
  • vulnerable plaques it is a mechanical treatment method, and its advantage is that it can quickly solve the fundamental problem, achieve precise treatment, and achieve the purpose of quickly and thoroughly treating vulnerable plaques.
  • FIG1 is a schematic diagram of a plaque treatment device according to an embodiment of the present invention.
  • FIG2 is a schematic diagram of a preferred example of a plaque destruction mechanism and a content recovery mechanism according to an embodiment of the present invention
  • FIG3 is a partial enlarged view of the plaque destruction mechanism shown in FIG2 ;
  • FIG4 is a schematic diagram of a cross section of a catheter according to an embodiment of the present invention.
  • FIG5 is a schematic diagram of a preferred example of a driving mechanism according to an embodiment of the present invention.
  • FIG6 is a schematic diagram of another preferred example of a driving mechanism according to an embodiment of the present invention.
  • FIG7 is a schematic diagram of a preferred example of a sharp portion of an embodiment of the present invention.
  • FIG8 is a schematic diagram of the sharp portion of FIG3 piercing a target plaque
  • FIG9 is a schematic diagram of another preferred example of the plaque destruction mechanism and the content recovery mechanism according to the embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the sharp portion of FIG. 9 piercing the target plaque.
  • the singular forms “a”, “an”, and “the” include plural objects, the term “or” is generally used in a sense that includes “and/or”, the term “several” is generally used in a sense that includes “at least one”, and the term “at least two” is generally used in a sense that includes “two or more”.
  • the terms “first”, “second”, and “third” are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated.
  • features defined as “first”, “second”, and “third” may explicitly or implicitly include one or at least two of the features, and “one end” and “the other end” as well as “proximal end” and “distal end” generally refer to two corresponding parts, which include not only the endpoints.
  • proximal end and distal end are defined herein with respect to a plaque treatment device having an end for intervention in the human body and a manipulation end extending out of the body.
  • proximal end refers to a position of an element that is closer to the control end of a plaque treatment device that extends out of the body
  • distal end refers to a position of an element that is closer to the end of a plaque treatment device that is inserted into the human body and is therefore farther away from the control end of the plaque treatment device.
  • proximal end and distal end are defined herein relative to an operator such as a surgeon or clinician.
  • proximal end refers to a position of an element that is closer to the operator
  • distal end refers to a position of an element that is closer to the plaque treatment device and is therefore farther away from the operator.
  • installed refers to a position of an element that is closer to the operator
  • distal end refers to a position of an element that is closer to the plaque treatment device and is therefore farther away from the operator.
  • installed refers to a position of an element that is closer to the operator
  • distal end refers to a position of an element that is closer to the plaque treatment device and is therefore farther away from the operator.
  • installed”, “connected”, “connected”, and one element is “set” to another element should be understood in a broad sense and generally only mean that There is a connection, coupling, cooperation or transmission relationship between two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one
  • the object of the present invention is to provide a plaque treatment device to solve the problem that vulnerable plaques are currently mainly treated by drugs.
  • An embodiment of the present invention provides a plaque treatment device, which includes: a catheter 1, a plaque destruction mechanism 2 and a content recovery mechanism 3; the plaque destruction mechanism 2 is configured to switch between an execution state and a first storage state; wherein the plaque destruction mechanism 2 in the first storage state is loaded on the catheter 1 and is used to move with the catheter 1; the plaque destruction mechanism 2 in the execution state is used to destroy the wall 41 of the target plaque 4, and the content recovery mechanism 3 is used to recover the content of the target plaque 41.
  • the target plaque 4 can be a vulnerable plaque on the patient's blood vessel, or a plaque prosthesis on a blood vessel model, which can be used for operator training or surgical verification, etc.
  • the present invention does not limit the specific content of the target plaque 4.
  • FIG. 2 and 3 Please refer to Figures 2 and 3, and take a target plaque 4 formed on the side wall of a blood vessel 42 as an example for explanation.
  • the interior of the target plaque 4 contains some roughly solid contents (such as a lipid core) and some liquids, and the inner side of the target plaque 4 facing the blood vessel 42 is its wall 41. It can be understood that after the wall 41 of the target plaque 4 is destroyed by the plaque destruction mechanism 2, the contents in the target plaque 4 will flow into the blood vessel 42. The contents will flow to the narrow part with the blood and cause blockage, thereby triggering acute cardiovascular and cerebrovascular events.
  • the setting of the content recovery mechanism 3 can recover the contents flowing out of the target plaque 4.
  • the plaque destruction mechanism 2 can be used to physically destroy the wall 41 of the target plaque 4, and then the contents of the target plaque 4 can be recovered by the content recovery mechanism 3, and will not cause harm with the blood circulation. It is a mechanical treatment method for vulnerable plaques, and its advantage is that it can It can quickly solve the root problem, realize precise treatment, and achieve the goal of quickly and thoroughly treating vulnerable plaques.
  • the plaque destruction mechanism 2 has an execution state and a first storage state, and is configured to be able to switch between the execution state and the first storage state.
  • the main application scenario of the plaque treatment device provided in this embodiment is to intervene from the blood vessel 42 (or blood vessel model) and advance along the blood vessel to the target plaque 4.
  • the plaque destruction mechanism 2 is mainly in the first storage state, and it can move along the blood vessel 42 relatively smoothly with the catheter 1, and minimize or avoid damage to the blood vessel wall during the movement. It should be noted that there are many ways to implement the way in which the plaque destruction mechanism 2 is loaded on the catheter 1 when it is in the first storage state.
  • the plaque destruction mechanism 2 is radially telescopically arranged on the outside of the catheter 1.
  • the way in which the plaque destruction mechanism 2 is loaded on the catheter 1 can be to shrink along the radial direction until it is close to the outer peripheral wall of the catheter 1.
  • the way in which the plaque destruction mechanism 2 is loaded on the catheter 1 can be to shrink inside the catheter 1.
  • the present invention does not impose any special restrictions on the way in which the plaque destruction mechanism 2 is loaded on the catheter 1. However, it should be ensured that when the plaque destroying mechanism 2 is loaded on the catheter 1, it will not affect the forward and backward movement of the catheter 1 along the blood vessel 42.
  • the plaque destroying mechanism 2 in the execution state can extend out of the catheter 1, so that it can be used to puncture the package wall 41.
  • the target plaque 4 is located on the side wall of the roughly straight section of the blood vessel 42, and the plaque destroying mechanism 2 in the execution state can extend radially relative to the catheter 1.
  • the execution state of the plaque destroying mechanism 2 can also be that the plaque destroying mechanism 2 extends axially relative to the catheter 1, and those skilled in the art can understand and improve it based on the existing technology.
  • the plaque treatment device further comprises a driving mechanism 5; the driving mechanism 5 is used to drive the plaque destruction mechanism 2 to switch between the execution state and the first storage state; the plaque destruction mechanism 2 comprises a sharp portion 21 connected to the driving mechanism 5, and when the plaque destruction mechanism 2 switches from the first storage state to the execution state, the sharp portion 21 extends radially relative to the catheter 1, and is used to puncture the wall 41 of the target plaque 4.
  • the conversion of the plaque destruction mechanism 2 between the execution state and the first storage state can be achieved spontaneously without being driven.
  • the plaque destruction mechanism 2 comprises a self-expanding mesh stent, and when the mesh stent extends from the distal end of the catheter 1, it can expand spontaneously to achieve the conversion from the first storage state to the execution state.
  • the plaque destruction mechanism 2 is driven in the execution state by an additionally provided driving mechanism 5. The transition between the first storage state and the second storage state can reliably realize the state transition of the plaque destroying mechanism 2 and improve the action accuracy of the plaque destroying mechanism 2.
  • the driving mechanism 5 includes a slider 51 and a connecting rod 52, one end of the connecting rod 52 is connected to the slider 51, and the other end of the connecting rod 52 is connected to the plaque destruction mechanism 2; the slider 51 is used to move along the axial direction of the catheter 1 to drive the plaque destruction mechanism 2 to switch between the execution state and the first storage state through the connecting rod 52.
  • the movement of the slider 51 can be achieved by injecting or sucking a driving fluid (liquid or gas).
  • the driving mechanism 5 includes a slider accommodating chamber 53 and a driving fluid channel 54 arranged along the axial direction of the catheter 1, the radial outer contour shape of the slider 51 is adapted to the radial inner contour shape of the slider accommodating chamber 53, and the slider 51 is movably arranged in the slider accommodating chamber 53 along the axial direction; the driving fluid channel 54 is connected to the slider accommodating chamber 53, and the driving fluid channel 54 is used to inject the driving fluid into the slider accommodating chamber 53, or to absorb the driving fluid from the slider accommodating chamber 53, so as to drive the slider 51 to move along the axial direction.
  • the catheter 1 is a multi-lumen tube having multiple cavities in the radial direction, and the slider accommodating cavity 53 is one of the cavities.
  • a block 55 is provided at the proximal end of the slider accommodating cavity 53, and the slider 51 is movably arranged at the distal end of the slider accommodating cavity 53.
  • the radial outer contour of the slider 51 and the radial inner contour of the slider accommodating cavity 53 are both circular, and the outer diameter of the slider 51 matches the inner diameter of the slider accommodating cavity 53.
  • the slider 51 can be sealed against the slider accommodating cavity 53 while sliding, thereby limiting the volume of the slider accommodating cavity 53.
  • the driving fluid channel 54 may also be provided in the catheter 1, which is one of the cavities of the catheter 1.
  • the slider housing cavity 53 and the driving fluid channel 54 are the same cavity, and the two are separated by a block 55.
  • the block 55 has an axial through hole, and the slider housing cavity 53 and the driving fluid channel 54 are connected through the through hole provided on the block 55.
  • the proximal end of the driving fluid channel 54 extends out of the body along the catheter 1, and the operator can inject or aspirate the driving fluid through the proximal end of the driving fluid channel 54.
  • Such a configuration is conducive to reducing the radial size of the catheter 1 and improving the passability.
  • the driving fluid channel 54 may also be another cavity of the catheter 1 different from the slider accommodating cavity 53, or an additional cavity attached to the outside of the catheter 1, and the present invention is not limited to this.
  • the plaque destruction mechanism 2 includes an expansion base 22 disposed outside the catheter 1, the expansion base 22 extends along the axial direction of the catheter 1, the sharp portion 21 is disposed on the expansion base 22, the expansion base 22 is connected to the other end of the connecting rod 52, and the expansion base 22 is used to move radially under the drive of the connecting rod 52; wherein, when the plaque destruction mechanism 2 is in the first storage state, the expansion base 22 is close to the outer wall of the catheter 1; when the plaque destruction mechanism 22 is in the execution state, the expansion base 22 is radially away from the catheter 1 and is used to squeeze the wall 41 of the target plaque 4.
  • the two ends of the connecting rod 52 are respectively hinged to the expansion base 22 and the slider 51.
  • the end of the connecting rod 52 connected to the slider 5 is located inside the catheter 1, and the end connected to the extension base 22 is located outside the catheter 1, so the connecting rod 52 needs to pass through the catheter 1.
  • a through groove can be provided at a position corresponding to the connecting rod 52 in the catheter 1 to facilitate the passing of the connecting rod 52. In this way, the axial sliding of the slider 51 is converted into the radial movement of the extension base 22, thereby driving the sharp portion 21 to move radially to pierce the package wall 41.
  • the plaque destroying mechanism 2 includes at least two expansion bases 22, and the at least two expansion bases 22 are evenly distributed around the axis of the slider accommodating cavity 53, and each expansion base 22 is connected to the slider 51 through a corresponding connecting rod 52.
  • the at least two expansion bases 22 can be uniformly expanded in different directions.
  • the plaque destroying mechanism 2 includes at least two expansion bases 22, only one of the expansion bases 22 is provided with a sharp portion 21, and the other expansion bases 22 are only used for expansion and abutting against the inner wall of the blood vessel 42, providing a reaction force for the expansion base 22 provided with the sharp portion 21, so that the expansion base 22 provided with the sharp portion 21 can squeeze the target plaque 4 and squeeze out the contents of the target plaque 4 as much as possible.
  • the plaque destroying mechanism 2 includes two expansion bases 22, which are symmetrically distributed about the axis of the slider accommodating cavity 53.
  • the expansion base 22 may also be an annular grid body, which is connected to the slider 51 through a plurality of connecting rods 52.
  • the expansion base 22 can be driven to expand or contract radially uniformly.
  • the expansion base 22 may be, for example, an expansion arm or an expansion plate, and its number, size, cross-sectional shape, circumferential extension area, distribution and other parameters depend on the project implementation and the extrusion area of the target plaque 4.
  • the expansion base 22 is preferably made of stainless steel, titanium alloy, or
  • the plastic film is made of biocompatible materials such as organic polymers and should have a certain strength to achieve the extrusion of the target plaque 4.
  • the driving mechanism 5 includes two sliders 51 and at least two connecting rods 52 arranged in an axial direction; each slider 51 is connected to at least one connecting rod 52; and the two sliders 51 are configured to move synchronously in opposite directions.
  • the proximal end of the slider accommodating cavity 53 also uses another slider 51 to replace the fixed block 55, so that the space enclosed between the two sliders 51 defines the slider accommodating cavity 53. In this way, when the driving fluid is injected or sucked into the slider accommodating cavity 53 through the driving fluid channel 54, the two sliders 51 will move synchronously in opposite directions.
  • the two sliders 51 are connected to the extended base 22 through their respective corresponding connecting rods 52, so that the two sliders 51 that move synchronously and oppositely can simultaneously drive the two axial ends of the extended base 22 to move radially together, so that the extended base 22 can move relatively smoothly in the radial direction, for example, in the axial direction perpendicular to the slider accommodating cavity 53.
  • the slider 51 at the proximal end has an axially penetrating through hole, and the slider accommodating cavity 53 is communicated with the driving fluid channel 54 through the through hole opened on the slider 51 .
  • the movement of the slider 51 can be achieved by a threaded mechanical drive.
  • the driving mechanism 5 includes a threaded driving member 56 arranged along the axial direction of the catheter 1, and the slider 51 is threadedly connected to the threaded driving member 56.
  • the threaded driving member 56 is used to rotate to drive the slider 51 to move axially.
  • the threaded driving member 56 is a screw with an external thread
  • the slider 51 has an internal thread that matches the external thread of the screw, so that when the threaded driving member 56 rotates, the slider 51 can be driven to move axially.
  • the threaded driving member 56 can also be a sleeve with an internal thread
  • the slider 51 has an external thread that matches the internal thread of the sleeve, so that the slider 51 can also be driven to move axially by rotating the threaded driving member 56.
  • the driving mechanism 5 may also include two sliders 51 spaced apart in the axial direction, the two sliders 51 are simultaneously threadedly connected to the threaded driving member 56, and the threads of the two sliders 51 have opposite rotation directions, and the threaded driving member 56 has two sections of threads with opposite rotation directions to match the threads of the two sliders 51. With such a configuration, when the threaded driving member 56 rotates, it can synchronously drive the two sliders 51 to move synchronously in opposite directions.
  • the content recovery mechanism 3 includes: The sharp portion 21 is axially penetrated by a recovery hole 31 formed on the sharp portion 21.
  • the content recovery mechanism 3 also includes a recovery channel 32 extending along the axial direction of the catheter 1.
  • the recovery hole 31 is connected to the recovery channel 32.
  • the recovery channel 32 and the recovery hole 31 are used for sucking out the contents of the target plaque 4.
  • the sharp portion 21 is generally a hollow needle body, one end of which is sharp and can pierce the wall 41 of the target plaque 4 and enter the interior of the target plaque 4.
  • the extended base 22 provided with the sharp portion 21 is a hollow part with an inner cavity, the distal end of the inner cavity is closed, and the proximal end of the inner cavity is connected to a cavity of the catheter 1 through a connecting tube.
  • the recovery hole 31 is connected to the inner cavity of the extended base 22.
  • the inner cavity of the extended base 22, the connecting tube and the cavity of the catheter 1 connected in sequence from the distal end to the proximal end together constitute the recovery channel 32.
  • the proximal end of the recovery channel 32 extends out of the body, and the operator can recover the contents contained in the target plaque 4 through the recovery channel 32 and the recovery hole 31, for example, by suction, or by squeezing the target plaque 4 by expanding the base 22.
  • the inner diameter of the recovery channel 32 and the recovery hole 31 should be larger than the size of the contents so that the contents can be discharged smoothly.
  • the content recovery mechanism 3 also includes a plurality of side branch holes 33, which are opened on the side wall of the sharp portion 21 along the radial direction of the sharp portion 21 and are connected to the recovery hole 31; the side branch holes 33 allow the contents of the target plaque 4 to pass through.
  • the entire recovery process of the contents of the target plaque 4 by the content recovery mechanism 3 is examined.
  • the sharp portion 21 first pierces the package wall 41 to enter the target plaque 4.
  • the contents of the target plaque 4 can enter the recovery channel 32 through the recovery hole 31 of the sharp portion 21.
  • the expanded base 22 moves outward and abuts against the package wall 41, squeezing the target plaque 4.
  • the contents of the target plaque 4 can still enter the recovery channel 32 through the recovery hole 31 of the sharp portion 21. Furthermore, in order to remove the contents of the target plaque 4 as cleanly as possible, the expanded base 22 continues to move outward and squeeze the target plaque 4. At this stage, the tip of the sharp portion 21 may have pierced the entire target plaque 4 and penetrated into the blood vessel wall, or even pierced through the blood vessel wall to reach the extravascular tissue. At this stage, the distal end of the recovery hole 31 has exceeded the target plaque 4 and cannot allow the contents to pass through. The setting of the side branch hole 33 provides another way for the contents to enter the recovery hole 31.
  • the contents of the target plaque 4 can enter the recovery hole 31 through the side branch hole 33. It can be understood that since the side branch hole 33 allows the contents to pass through, its inner diameter should be larger than the size of the contents.
  • the outer diameter of the sharp portion 21 should be set as small as possible, for example, the inner diameter of the recovery hole 31 is slightly larger than the possible maximum size of the contents.
  • the plaque destruction mechanism 2 includes more than two sharp portions 21. Increasing the number of sharp portions 21 can reduce the negative impact of the size of the sharp portion 21 on the effectiveness. In one embodiment, the more than two sharp portions 21 are arranged on the same extended base 22.
  • the driving mechanism 5 includes a driving wire (not shown) and a guide 57, wherein the driving wire is connected to the sharp portion 21; the guide 57 is used to guide and change the extension direction of the driving wire, so as to allow the driving wire to drive the plaque destruction mechanism 2 to switch between the execution state and the first storage state; wherein, when the plaque destruction mechanism 2 is in the first storage state, the sharp portion 21 does not exceed the guide 57 and the catheter 1, whichever is closer to the outside; when the plaque destruction mechanism 2 switches from the first storage state to the execution state, the sharp portion 21 extends out of the guide 57 and the catheter 1 in a direction that is angled with the axial direction of the catheter 1 under the drive of the driving wire, so as to puncture the wall 41 of the target plaque 4.
  • the guide 57 may be entirely located in the catheter 1, that is, the catheter 1 is located closer to the outside of the guide 57 and the catheter 1, and the plaque destruction mechanism 2 is in the first storage state, which means that the sharp portion 21 does not extend out of the catheter 1.
  • the guide member 57 may partially extend out of the catheter 1, that is, the guide member 57 is located further out of the catheter 1. In this case, even if the sharp portion 21 extends out of the outer wall of the catheter 1, as long as it does not extend beyond the guide member 57, it does not matter.
  • the guide member 57 is a tubular member, which includes an extension tube segment 571 located in the catheter 1, and the extension tube segment 571 may be a lumen of the catheter 1. Further, the guide member 57 also includes an arc-shaped extending guide tube segment 572, and the proximal end of the guide tube segment 572 extends tangentially along the axial direction of the catheter 1, for example, connected to the extension tube segment 571. The distal end of the guide tube segment 572 extends tangentially at an angle to the axial direction of the catheter 1 and penetrates the outer wall of the catheter 1.
  • the guide tube segment 572 is used for the drive wire to be movably passed through, and is used to guide and change the extension direction of the drive wire.
  • the proximal end of the drive wire passes through the extension tube segment 571 and extends out of the body, and the operator can operate the drive wire to move forward and backward.
  • the drive wire is movably passed through the guide member 57, and its advance and retreat direction will be
  • the driving wire and the sharp portion 21 disposed at the distal end thereof are restricted and guided by the guide member 57.
  • the driving wire and the sharp portion 21 are moved to the distal end to the guide tube section 572, they gradually turn outward.
  • the extension direction of the driving wire and the sharp portion 21 forms an angle with the axial direction of the catheter 1, until the driving wire is extended out of the catheter 1.
  • the driving wire is further pushed to the distal end, so that the sharp portion 21 extends out of the guide tube section 572, and the plaque destruction mechanism 2 is converted to the execution state. It can be understood that when the sharp portion 21 does not extend out of the guide tube section 572, the plaque destruction mechanism 2 can be considered to be in the first storage state.
  • the content recovery mechanism 3 adapted to the plaque destruction mechanism 2 in the exemplary embodiment shown in FIG9 and FIG10 may also be the same as the aforementioned exemplary embodiment, that is, it includes a recovery hole 31 and a recovery channel 32. After the sharp portion 21 pierces the wall 41 of the target plaque 4 and enters the interior of the target plaque 4, the content of the target plaque 4 can be sucked out by suction at the proximal end of the recovery channel 32.
  • the present embodiment provides another preferred example of a content recovery mechanism 3, wherein the content recovery mechanism 3 includes a blocking member 34, wherein the blocking member 34 has selective permeability and allows a permeable size that is not larger than a size of part of the content; the blocking member 34 is configured to switch between a blocking state and a second storage state; when the blocking member 34 is in the blocking state, it is used to block the downstream side of the target plaque 4 to collect the contents whose size is larger than the allowable permeable size; when the blocking member 34 is in the second storage state, it is loaded on the catheter 1 and is used to move with the catheter 1; wherein, during the process of switching from the blocking state to the second storage state, the collected contents are prevented from escaping from the blocking member 34.
  • the blocking member 34 has selective permeability and allows a permeable size that is not larger than a size of part of the content
  • the blocking member 34 is configured to switch between a blocking state and a second storage state; when the blocking member 34 is in the blocking state, it is used to block
  • the blocking member 34 includes an expandable and contractible elastic structure, such as a mesh support made of nickel-titanium wire, so that the blocking member 34 can be contracted and received in the catheter 1, so as to move with the catheter 1 and be transported into the blood vessel 42.
  • the blocking member 34 is driven to extend out of the distal end of the catheter 1, and then the blocking member 34 expands and blocks the downstream of the target plaque 4.
  • the downstream here refers to the downstream side along the blood flow in the blood vessel 42.
  • the blood flow direction is from left to right, and the blocking member 34 is located on the right side of the target plaque 4.
  • the blocking member 34 also includes a semipermeable membrane, which is covered on the elastic structure.
  • the semipermeable membrane and the elastic structure can completely cover the entire cross-section of the blood vessel 42.
  • the semipermeable membrane has selective permeability, and the size allowed to pass is not greater than the size of part of the contents.
  • the permeable size is larger than the size of blood cells and other blood substances.
  • the semipermeable membrane can allow blood cells and other blood substances to pass through.
  • the collected contents can be prevented from escaping from the blocking member 34.
  • the elastic structure of the blocking member 34 is, for example, umbrella-shaped, and the contents will not be escaping when the blocking member 34 moves toward the proximal end and is stored in the catheter 1.
  • the sharp portion 21 may be in the shape of a blade, which can not only penetrate into the target plaque 4 , but also be used to cut open the package wall 41 , so that the contents in the target plaque 4 can quickly flow out into the blood vessel 42 .
  • the catheter 1 is transported along the guide wire to the vicinity of the target plaque 4, and the catheter 1 can rotate circumferentially, and the distal end of the guide tube section 572 is tangentially facing the target plaque 4.
  • the driving blockage member 34 is released at the downstream position of the target plaque 4 and converted to a blocking state to block in the blood vessel 42, and then the driving wire and the sharp portion 21 are pushed forward, so that the driving wire and the sharp portion 21 move forward and extend out of the catheter 1 under the guidance of the guide tube section 572 until the sharp portion 21 faces the target plaque 4; at this time, the sharp portion 21 is operated to cut the wall 41 of the target plaque 4 and release the contents in the target plaque 4.
  • the contents reach the vicinity of the blocking member 34 under the action of blood flow, and are blocked by the semipermeable membrane under the action of blood pressure and collected by the blocking member 34.
  • the plugging member 34 can be recovered and switched to the second storage state, and the plugging member 34 together with the filtered and collected contents can be loaded into the catheter 1 and withdrawn from the body.
  • the preferred example of the content recovery mechanism 3 including the plugging member 34 is not limited to the examples shown in Figures 9 and 10, and can also be applied to the preferred example shown in Figure 2.
  • the content recovery mechanism 3 is not limited to only including one of the plugging member 34 or the recovery hole 31, and can also be a combination of both.
  • the solution of the plugging member 34 can also be combined, so that once a small amount of content is squeezed and leaks out from the bag wall 41, it can also be recovered by the plugging member 34, thereby improving reliability and safety.
  • the plaque treatment device includes a catheter, a plaque destruction mechanism and a content recovery mechanism; the plaque destruction mechanism is configured to switch between an execution state and a first storage state. conversion; wherein the plaque destruction mechanism in the first storage state is loaded on the catheter and is used to move with the catheter; the plaque destruction mechanism in the execution state is used to destroy the wall of the target plaque, and the content recovery mechanism is used to recover the contents of the target plaque.
  • the plaque destruction mechanism can be used to physically destroy the wall of the target plaque, and then the contents of the target plaque can be recovered by the content recovery mechanism without causing harm with the blood circulation. It is a mechanical treatment method for vulnerable plaques, and its advantage is that it can quickly solve the fundamental problem, realize precise treatment, and achieve the purpose of quickly and thoroughly treating vulnerable plaques.

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Abstract

本发明提供一种斑块治疗装置，其包括导管、斑块破坏机构及内容物回收机构；所述斑块破坏机构被配置为在执行状态和第一收纳状态之间转换；其中，处于所述第一收纳状态的所述斑块破坏机构装载于所述导管，并用于随所述导管运动；处于所述执行状态的所述斑块破坏机构用于破坏目标斑块的包壁，所述内容物回收机构用于回收所述目标斑块的内容物。如此配置，斑块破坏机构能够用于以物理的方式破坏目标斑块的包壁，进而目标斑块的内容物能够被内容物回收机构回收，不会随血液循环造成危害。对于易损斑块是一种机械性的治疗方式，其优势在于能够快速解决根本问题，实现精准治疗，达到快速而彻底治疗易损斑块的目的。

Description

斑块治疗装置 技术领域
本发明涉及医疗器械技术领域，特别涉及一种斑块治疗装置。
背景技术
易损斑块又称不稳定斑块、软斑块、高危斑块等，指的是动脉粥样硬化斑块中迅速、具有血栓形成倾向的不稳定性的高危斑块。此类斑块的特点在于纤维帽薄、脂质核心大导致极易发生破裂、稳定性差，容易发生急性心脑血管事件，例如有些患者的狭窄程度并不严重(低于50％)，但是由于是易损斑块，随时可能发生如心肌梗死、心脏骤停、急性脑梗等急性心脑血管事件，临床显示有75％的急性心肌梗死是由于易损斑块的破裂导致，严重影响人们的生活水平。
易损斑块的治疗方式目前主要是药物治疗，例如利用他汀类药物来进行强化降脂是目前最主要的治疗手段。此外还有一些其它药物如：抗凝血和抗血小板药物通过减轻动脉局部的炎症反应、抑制斑块破裂后血栓形成；GPⅡb/Ⅲa拮抗剂和肝素(UFH)使用后不仅提高灌注水平且降低栓塞的程度；钙离子拮抗剂延缓冠状动脉粥样硬化的进程等药物都能对易损斑块的治疗起到一定的作用。然而这些药物治疗的方式，均存在起效慢，治疗周期长，疗效不可靠等问题。
发明内容
本发明的目的在于提供一种斑块治疗装置，以解决现有的易损斑块主要通过药物治疗的问题。
为解决上述技术问题，本发明提供一种斑块治疗装置，其包括：导管、斑块破坏机构及内容物回收机构；所述斑块破坏机构被配置为在执行状态和第一收纳状态之间转换；
其中，处于所述第一收纳状态的所述斑块破坏机构装载于所述导管，并用于随所述导管运动；处于所述执行状态的所述斑块破坏机构用于破坏目标 斑块的包壁，所述内容物回收机构用于回收所述目标斑块的内容物。
可选的，所述斑块治疗装置还包括驱动机构；所述驱动机构用于驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换；所述斑块破坏机构包括与所述驱动机构连接的尖锐部，所述斑块破坏机构自所述第一收纳状态向所述执行状态转换时，所述尖锐部相对所述导管沿径向伸出，用于刺破所述目标斑块的包壁。
可选的，所述驱动机构包括滑块及连杆，所述连杆的一端与所述滑块连接，所述连杆的另一端与所述斑块破坏机构连接；所述滑块用于沿所述导管的轴向移动，以通过所述连杆驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换。
可选的，所述驱动机构包括沿所述导管的轴向设置的滑块容置腔及驱动流体通道，所述滑块的径向外轮廓形状与所述滑块容置腔的径向内轮廓形状相适配，所述滑块沿轴向可移动地设置于所述滑块容置腔内；所述驱动流体通道与所述滑块容置腔连通，所述驱动流体通道用于供驱动流体注入所述滑块容置腔，或自所述滑块容置腔吸取所述驱动流体，以驱使所述滑块沿轴向移动。
可选的，所述驱动机构包括沿所述导管的轴向设置的螺纹驱动件，所述滑块与所述螺纹驱动件螺纹连接，所述螺纹驱动件用于自转，以驱动所述滑块沿轴向移动。
可选的，所述驱动机构包括两个沿轴向间隔布置的滑块以及至少两个连杆；每个所述滑块与至少一个所述连杆连接；两个所述滑块被配置为同步地沿相反的方向移动。
可选的，所述斑块破坏机构包括设置于所述导管外的扩展基体，所述扩展基体沿所述导管的轴向延伸，所述尖锐部设置于所述扩展基体上，所述扩展基体与所述连杆的另一端连接，所述扩展基体用于在所述连杆的驱动下沿径向移动；其中，所述斑块破坏机构处于所述第一收纳状态时，所述扩展基体贴靠于所述导管的外壁；所述斑块破坏机构处于所述执行状态时，所述扩展基体沿径向远离所述导管，并用于挤压所述目标斑块的包壁。
可选的，所述斑块治疗装置还包括驱动机构；所述驱动机构用于驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换；所述斑块破坏机构包括与所述驱动机构连接的尖锐部；所述驱动机构包括驱动丝及导引件，所述驱动丝与所述尖锐部连接；所述导引件用于导引和改变所述驱动丝的延伸方向；其中，所述斑块破坏机构处于所述第一收纳状态时，所述尖锐部不超出所述导引件和所述导管中更靠外的一者；所述斑块破坏机构自所述第一收纳状态向所述执行状态转换时，所述尖锐部在所述驱动丝的驱动下沿与所述导管的轴向成角度的方向伸出所述导引件和所述导管，用于刺破所述目标斑块的包壁。
可选的，所述导引件包括弧形延伸的导向管段，所述导向管段的近端切向沿所述导管的轴向延伸，所述导向管段的远端切向与所述导管的轴向成角度延伸并穿透所述导管的外壁；所述导向管段用于供所述驱动丝可活动地穿设，并用于导引和改变所述驱动丝的延伸方向。
可选的，所述内容物回收机构包括堵塞件，所述堵塞件具有选择性透过性，其允许透过尺寸不大于部分所述内容物的尺寸；所述堵塞件被配置为在堵塞状态和第二收纳状态之间转换；
所述堵塞件处于所述堵塞状态时，用于封堵于所述目标斑块的下游侧，以收集尺寸大于所述允许透过尺寸的所述内容物；
所述堵塞件处于所述第二收纳状态时，装载于所述导管，并用于随所述导管运动；
其中，所述堵塞件由所述堵塞状态转换至所述第二收纳状态的过程中，阻止所收集的所述内容物脱离所述堵塞件。
可选的，所述斑块破坏机构包括尖锐部，所述内容物回收机构包括沿所述尖锐部的轴向贯通开设于所述尖锐部上的回收孔，还包括沿所述导管的轴向延伸设置的回收通道，所述回收孔与所述回收通道连通；所述回收通道和所述回收孔用于供抽吸出所述目标斑块的内容物。
可选的，所述内容物回收机构还包括多个旁支孔，所述旁支孔沿所述尖锐部的径向开设于所述尖锐部的侧壁，并与所述回收孔连通；所述旁支孔允 许所述目标斑块的内容物通过。
可选的，所述导管为多腔管。
综上所述，在本发明提供的斑块治疗装置包括导管、斑块破坏机构及内容物回收机构；所述斑块破坏机构被配置为在执行状态和第一收纳状态之间转换；其中，处于所述第一收纳状态的所述斑块破坏机构装载于所述导管，并用于随所述导管运动；处于所述执行状态的所述斑块破坏机构用于破坏目标斑块的包壁，所述内容物回收机构用于回收所述目标斑块的内容物。
如此配置，斑块破坏机构能够用于以物理的方式破坏目标斑块的包壁，进而目标斑块的内容物能够被内容物回收机构回收，不会随血液循环造成危害。对于易损斑块是一种机械性的治疗方式，其优势在于能够快速解决根本问题，实现精准治疗，达到快速而彻底治疗易损斑块的目的。
附图说明
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限定。其中：
图1是本发明实施例的斑块治疗装置的示意图；
图2是本发明实施例的斑块破坏机构和内容物回收机构的一个优选示例的示意图；
图3是图2所示的斑块破坏机构的局部放大图；
图4是本发明实施例的导管的横截面的示意图；
图5是本发明实施例的驱动机构的一个优选示例的示意图；
图6是本发明实施例的驱动机构的另一个优选示例的示意图；
图7是本发明实施例的尖锐部的一个优选示例的示意图；
图8是图3的尖锐部刺入目标斑块的示意图；
图9是本发明实施例的斑块破坏机构和内容物回收机构的另一个优选示例的示意图；
图10是图9的尖锐部刺入目标斑块的示意图。
附图中：
1-导管；2-斑块破坏机构；21-尖锐部；22-扩展基体；3-内容物回收机构；
31-回收孔；32-回收通道；33-旁支孔；34-堵塞件；4-目标斑块；41-包壁；42-血管；5-驱动机构；51-滑块；52-连杆；53-滑块容置腔；54-驱动流体通道；55-堵块；56-螺纹驱动件；57-导引件；571-延伸管段；572-导向管段。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。
如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，术语“或”通常是以包括“和/或”的含义而进行使用的，术语“若干”通常是以包括“至少一个”的含义而进行使用的，术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的，此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征，“一端”与“另一端”以及“近端”与“远端”通常是指相对应的两部分，其不仅包括端点。术语“近端”和“远端”在本文中相对于斑块治疗装置定义，该斑块治疗装置具有用于介入人体的一端与伸出体外的操控端。术语“近端”是指元件的更靠近斑块治疗装置之伸出体外的操控端的位置，术语“远端”是指元件的更靠近斑块治疗装置之介入人体的一端且因此更远离斑块治疗装置之操控端的位置。可选的，在手动或用手操作的应用场景中，术语“近端”和“远端”在本文中相对于操作者诸如外科医生或临床医生来定义。术语“近端”是指元件的更靠近操作者的位置，并且术语“远端”是指元件的更靠近斑块治疗装置并且因此更远离操作者的位置。此外，如在本发明中所使用的，“安装”、“相连”、“连接”，一元件“设置”于另一元件，应做广义理解，通常仅表示 两元件之间存在连接、耦合、配合或传动关系，且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动，而不能理解为指示或暗示两元件之间的空间位置关系，即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位，除非内容另外明确指出外。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。此外，诸如上方、下方、上、下、向上、向下、左、右等的方向术语相对于示例性实施方案如它们在图中所示进行使用，向上或上方向朝向对应附图的顶部，向下或下方向朝向对应附图的底部。
本发明的目的在于提供一种斑块治疗装置，以解决现有的易损斑块主要通过药物治疗的问题。
以下参考附图进行描述。
请参考图1至图8，本发明实施例提供一种斑块治疗装置，其包括：导管1、斑块破坏机构2及内容物回收机构3；所述斑块破坏机构2被配置为在执行状态和第一收纳状态之间转换；其中，处于所述第一收纳状态的所述斑块破坏机构2装载于所述导管1，并用于随所述导管1运动；处于所述执行状态的所述斑块破坏机构2用于破坏目标斑块4的包壁41，所述内容物回收机构3用于回收所述目标斑块41的内容物。需要说明的，目标斑块4如可为患者的血管上的易损斑块，也可以是在血管模型上的斑块假体，其可供操作者进行训练或手术验证等，本发明对目标斑块4的具体内容不作限制。
请参考图2和图3，以一个形成于血管42的侧壁上的目标斑块4为例进行说明，目标斑块4的内部容置有一些大致呈固态的内容物(如脂质核心)和一些液体，目标斑块4朝向血管42的内侧为其包壁41。可以理解的，采用斑块破坏机构2破坏目标斑块4的包壁41后，目标斑块4中的内容物会流入到血管42中。内容物随血液流动至狭窄处，将会产生堵塞，从而引发急性心脑血管事件。而内容物回收机构3的设置，能够回收从目标斑块4中流出的内容物，如此配置，斑块破坏机构2能够用于以物理的方式破坏目标斑块4的包壁41，进而目标斑块4的内容物能够被内容物回收机构3回收，不会随血液循环造成危害。对于易损斑块是一种机械性的治疗方式，其优势在于能 够快速解决根本问题，实现精准治疗，达到快速而彻底治疗易损斑块的目的。
进一步的，斑块破坏机构2具有执行状态和第一收纳状态，并且被配置为能够在执行状态和第一收纳状态之间转换。本实施例提供的斑块治疗装置主要的应用场景是自血管42(或血管模型)介入，沿血管前进至目标斑块4处。在介入过程中，斑块破坏机构2主要处于第一收纳状态，其能较顺畅地随导管1一同沿血管42移动，并且在移动过程中尽量减少或避免对血管壁造成危害。需要说明的，处于第一收纳状态时的斑块破坏机构2装载于导管1的方式，可以有多种实现方式。例如图1和图2示出的示范例中，斑块破坏机构2是沿径向可伸缩地设置在导管1的外部的，此时斑块破坏机构2装载于导管1的方式，可以是沿径向收缩，至贴靠在导管1的外周壁上。另一些实施例中，例如图9示出的示范例中，斑块破坏机构2装载于导管1的方式，可以是收缩在导管1的内部。基于上述说明，本发明对斑块破坏机构2装载于导管1的方式不作特别的限制。但应保证斑块破坏机构2装载于导管1时，不至于影响导管1沿血管42的进退移动。处于执行状态时的斑块破坏机构2能够伸出导管1之外，从而能够用来刺破包壁41。一些实施例中，目标斑块4位于血管42大致平直段的侧壁上，则处于执行状态时的斑块破坏机构2可以相对导管1的径向伸出。另一些实施例中，目标斑块4位于血管42的转弯处时，斑块破坏机构2的执行状态也可以是斑块破坏机构2相对导管1的轴向伸出，本领域技术人员可根据现有技术进行理解和改进。
优选的，所述斑块治疗装置还包括驱动机构5；所述驱动机构5用于驱动所述斑块破坏机构2在所述执行状态和所述第一收纳状态之间转换；所述斑块破坏机构2包括与所述驱动机构5连接的尖锐部21，所述斑块破坏机构2自所述第一收纳状态向所述执行状态转换时，所述尖锐部21相对所述导管1沿径向伸出，用于刺破所述目标斑块4的包壁41。一些实施例中，斑块破坏机构2在执行状态和第一收纳状态之间的转换可以不经由驱动，自发实现。例如斑块破坏机构2包括具有自膨性的网状支架，则在网状支架自导管1的远端伸出时，其能够自发地膨胀，而实现从第一收纳状态转换至执行状态。但是较佳的，通过额外设置的驱动机构5，来驱动斑块破坏机构2在执行状态 和第一收纳状态之间的转换，能够可靠地实现斑块破坏机构2的状态转换，提高斑块破坏机构2的动作精确度。
如图2所示，可选的，所述驱动机构5包括滑块51及连杆52，所述连杆52的一端与所述滑块51连接，所述连杆52的另一端与所述斑块破坏机构2连接；所述滑块51用于沿所述导管1的轴向移动，以通过所述连杆52驱动所述斑块破坏机构2在所述执行状态和所述第一收纳状态之间转换。
在一个优选示例中，滑块51的移动可通过驱动流体(液体或气体)的注入或抽吸来实现。可选的，所述驱动机构5包括沿所述导管1的轴向设置的滑块容置腔53及驱动流体通道54，所述滑块51的径向外轮廓形状与所述滑块容置腔53的径向内轮廓形状相适配，所述滑块51沿轴向可移动地设置于所述滑块容置腔53内；所述驱动流体通道54与所述滑块容置腔53连通，所述驱动流体通道54用于供驱动流体注入所述滑块容置腔53，或自所述滑块容置腔53吸取所述驱动流体，以驱使所述滑块51沿轴向移动。
请参考图4和图5，可选的，导管1为多腔管，其沿径向具有多个腔道，滑块容置腔53为其中一个腔道。在一个实施例中，滑块容置腔53的近端设有堵块55，滑块51则可活动地设置在滑块容置腔53的远端。较佳的，滑块51的径向外轮廓形状和滑块容置腔53的径向内轮廓形状均为圆形，滑块51的外径与滑块容置腔53的内径相匹配，滑块51能够在滑动的同时与滑块容置腔53密闭抵靠，从而限定了滑块容置腔53的容积。如此配置，在通过驱动流体通道54对滑块容置腔53注入驱动流体时，滑块51将被推往远端方向(图5中为右侧方向)移动。反之，通过驱动流体通道54从滑块容置腔53抽吸驱动流体时，滑块51将被推往近端方向(图5中为左侧方向)移动。可选的，驱动流体通道54也可开设在导管1内，其为导管1的其中一个腔道。优选的，滑块容置腔53与驱动流体通道54为同一腔道，两者被堵块55所分隔开，同时堵块55具有轴向贯通的通孔，滑块容置腔53与驱动流体通道54通过开设在堵块55上的通孔连通。驱动流体通道54的近端沿导管1伸出体外，操作者可通过驱动流体通道54的近端注入或抽吸驱动流体。如此配置有利于减小导管1的径向尺寸，有利于提高通过性。当然在其它的一些实施例 中，驱动流体通道54也可以是导管1的不同于滑块容置腔53的另一个腔道，或者是贴附在导管1外的附设腔道，本发明对此不限。
进一步的，在一个实施例中，所述斑块破坏机构2包括设置于所述导管1外的扩展基体22，所述扩展基体22沿所述导管1的轴向延伸，所述尖锐部21设置于所述扩展基体22上，所述扩展基体22与所述连杆52的另一端连接，所述扩展基体22用于在所述连杆52的驱动下沿径向移动；其中，所述斑块破坏机构2处于所述第一收纳状态时，所述扩展基体22贴靠于所述导管1的外壁；所述斑块破坏机构22处于所述执行状态时，所述扩展基体22沿径向远离所述导管1，并用于挤压所述目标斑块4的包壁41。可选的，连杆52的两端分别与扩展基体22和滑块51铰接。可选的，连杆52与滑块5连接的一端位于导管1内，与扩展基体22连接的一端位于导管1外，因此连杆52需穿出导管1，为此，导管1对应于连杆52的位置可开设通槽，以便于连杆52穿设。这样滑块51的轴向滑动即转换为扩展基体22的径向移动，从而带动尖锐部21沿径向移动，而用于刺破包壁41。
优选的，斑块破坏机构2包括至少两个扩展基体22，至少两个扩展基体22围绕滑块容置腔53的轴线周向均匀分布，每个扩展基体22通过一个对应的连杆52与滑块51连接。如此配置，滑块51轴向移动时，至少两个扩展基体22可实现均匀地向不同的方向扩张。需要说明的，在斑块破坏机构2包括至少两个扩展基体22时，其中仅1个扩展基体22上设置有尖锐部21，其它的扩展基体22仅用于扩张而与血管42的内壁抵靠，为设置有尖锐部21的扩展基体22提供反作用力，以使得设置有尖锐部21的扩展基体22能够挤压目标斑块4，而将目标斑块4的内容物尽量地挤出。图5示出的示范例中，斑块破坏机构2包括两个扩展基体22，其关于滑块容置腔53的轴线对称分布。在其它的一些实施例中，扩展基体22也可以为环形的网格体，其通过多根连杆52与滑块51连接。这样滑块51轴向移动时，可以驱使扩展基体22径向均匀地扩张或收缩。可选的，扩展基体22例如可为扩展臂或扩展板，其数量、尺寸、横截面形状、周向的延伸面积、分布情况等参数取决于工程实施情况以及对目标斑块4的挤压面积而定。扩展基体22优选选用不锈钢、钛合金、有 机高分子等生物相容性材料制成，其应具备一定的强度，以实现对目标斑块4的挤压。
请继续参考图5，在另一个可选的实施例中，所述驱动机构5包括两个沿轴向间隔布置的滑块51以及至少两个连杆52；每个所述滑块51与至少一个所述连杆52连接；两个所述滑块51被配置为同步地沿相反的方向移动。滑块容置腔53的近端也利用另一滑块51来替代固定设置的堵块55，这样两个滑块51之间所封闭的空间即限定形成滑块容置腔53。这样当通过驱动流体通道54向滑块容置腔53中注入或抽吸驱动流体时，两个滑块51将会同步地沿相反的方向移动。进一步的，两个滑块51通过各自对应的连杆52与扩展基体22连接，这样两个同步相反移动的滑块51能够同时驱动扩展基体22的轴向的两个端部一同沿径向移动，从而可使得扩展基体22能够较为平顺地沿径向移动，例如沿垂直于滑块容置腔53的轴向移动。可选的，位于近端的滑块51具有轴向贯通的通孔，滑块容置腔53与驱动流体通道54通过开设在滑块51上的通孔连通。
请参考图6，在另一个优选示例中，滑块51的移动可通过螺纹机械驱动来实现。可选的，所述驱动机构5包括沿所述导管1的轴向设置的螺纹驱动件56，所述滑块51与所述螺纹驱动件56螺纹连接，所述螺纹驱动件56用于自转，以驱动所述滑块51沿轴向移动。在一个实施例中，螺纹驱动件56为具有外螺纹的丝杆，而滑块51具有与丝杆的外螺纹相适配的内螺纹，这样螺纹驱动件56转动时，即可驱动滑块51沿轴向移动。在另一个实施例中，螺纹驱动件56也可以为具有内螺纹的套筒，而滑块51具有与套筒的内螺纹相匹配的外螺纹，这样同样可以实现通过螺纹驱动件56转动而驱动滑块51沿轴向移动。进一步的，驱动机构5同样可以包括两个沿轴向间隔布置的滑块51，该两个滑块51同时与螺纹驱动件56螺纹连接，并且两个滑块51的螺纹的旋向相反，相适配的，螺纹驱动件56具有两段旋向相反的螺纹，以与两个滑块51的螺纹相匹配。如此配置，螺纹驱动件56在转动时，能够同步地驱动两个滑块51同步地沿相反的方向移动。
可选的，请参考图3，在一个优选示例中，所述内容物回收机构3包括沿 所述尖锐部21的轴向贯通开设于所述尖锐部21上的回收孔31，所述内容物回收机构3还包括沿所述导管1的轴向延伸设置的回收通道32，所述回收孔31与所述回收通道32连通；所述回收通道32和所述回收孔31用于供抽吸出所述目标斑块4的内容物。在该优选示例中，尖锐部21大致为中空的针体，其一端尖锐，能够刺破目标斑块4的包壁41而进入目标斑块4的内部。优选的，设置有尖锐部21的扩展基体22为具有内腔的中空件，内腔的远端封闭，内腔的近端通过连接管与导管1的一个腔道连通。回收孔31与扩展基体22的内腔连通。这样自远端向近端依次连接的扩展基体22的内腔、连接管与导管1的腔道共同构成了回收通道32。回收通道32的近端伸出体外，操作者可通过回收通道32和回收孔31回收目标斑块4内部所容置的内容物，例如可以抽吸，也可以通过扩展基体22对目标斑块4的挤压而将内容物挤出。可以理解的，回收通道32和回收孔31的内径应大于内容物的尺寸，以使得内容物能够顺畅地被排出。
请参考图7和图8，进一步的，所述内容物回收机构3还包括多个旁支孔33，所述旁支孔33沿所述尖锐部21的径向开设于所述尖锐部21的侧壁，并与所述回收孔31连通；所述旁支孔33允许所述目标斑块4的内容物通过。结合参考图3，考察内容物回收机构3对目标斑块4的内容物的整个回收流程，尖锐部21首先刺破包壁41进入目标斑块4，该阶段时目标斑块4的内容物可通过尖锐部21的回收孔31进入回收通道32。进而扩展基体22向外移动而与包壁41抵靠，对目标斑块4产生挤压。该阶段时目标斑块4的内容物仍可通过尖锐部21的回收孔31进入回收通道32。进一步的，为了使目标斑块4的内容物能够尽可能排除干净，扩展基体22继续向外移动并挤压目标斑块4，此阶段尖锐部21的尖端有可能已经刺穿整个目标斑块4而穿入血管壁，甚至刺穿血管壁而到达血管外组织中。此阶段回收孔31的远端已超出了目标斑块4而无法供内容物通过。而旁支孔33的设置，即为内容物提供了进入回收孔31的另一途径，通过扩展基体22继续挤压目标斑块4时，目标斑块4的内容物可通过旁支孔33进入回收孔31。可以理解的，由于旁支孔33允许内容物通过，因此其内径应大于内容物的尺寸。
进一步的，为了避免对血管42的过度损伤，尖锐部21的外径应尽可能设置得较小，例如使回收孔31的内径略大于内容物可能的最大尺寸。为加快内容物的排出速度，斑块破坏机构2包括两个以上的尖锐部21。增加尖锐部21的数量，可降低尖锐部21的尺寸对有效性带来的负面影响。一个实施例中，两个以上的尖锐部21均布置于同一扩展基体22上。
请参考图9和图10，在另一个优选示例中，所述驱动机构5包括驱动丝(未图示)及导引件57，所述驱动丝与所述尖锐部21连接；所述导引件57用于导引和改变所述驱动丝的延伸方向，以允许所述驱动丝驱动所述斑块破坏机构2在所述执行状态和所述第一收纳状态之间转换；其中，所述斑块破坏机构2处于所述第一收纳状态时，所述尖锐部21不超出所述导引件57和所述导管1中更靠外的一者；所述斑块破坏机构2自所述第一收纳状态向所述执行状态转换时，所述尖锐部21在所述驱动丝的驱动下沿与所述导管1的轴向成角度的方向伸出所述导引件57和所述导管1，用于刺破所述目标斑块4的包壁41。具体的，一些实施例中，导引件57可能全部位于导管1内，也就是说，导引件57和导管1两者中，导管1是位于更靠外的一者，此时斑块破坏机构2处于第一收纳状态，是指尖锐部21不伸出导管1。此时即使尖锐部21伸出导引件57，只要不超出导管1的外壁，则均能够被导管1所遮蔽和保护。另一些实施例中，导引件57可能有部分伸出导管1外，也就是说，导引件57和导管1两者中，导引件57是位于更靠外的一者。此时即使尖锐部21伸出导管1的外壁之外，只要不伸出导引件57亦无妨。
如图9所示，在一个示范例中，导引件57为管状件，其包括位于导管1内的延伸管段571，延伸管段571如可为导管1的一个腔道。进一步，导引件57还包括弧形延伸的导向管段572，所述导向管段572的近端切向沿所述导管1的轴向延伸，例如与延伸管段571连接。所述导向管段572的远端切向与所述导管1的轴向成角度延伸并穿透所述导管1的外壁。所述导向管段572用于供所述驱动丝可活动地穿设，并用于导引和改变所述驱动丝的延伸方向。可选的，驱动丝的近端穿过延伸管段571并伸出体外，操作者可操作驱动丝进退移动。可以理解的，驱动丝可活动地穿设在导引件57中，其进退方向会 受到导引件57的限制和引导。驱动丝及设置在其远端的尖锐部21向远端移至导向管段572时，逐渐向外转折。进而在通过导向管段572后，驱动丝与尖锐部21的延伸方向即与导管1的轴向形成角度，至伸出导管1。进一步向远端推送驱动丝，使尖锐部21伸出导向管段572，斑块破坏机构2即转换至所述执行状态。可以理解的，尖锐部21未伸出导向管段572时，可认为斑块破坏机构2处于所述第一收纳状态。
适配于图9和图10所示出的示范例中的斑块破坏机构2，内容物回收机构3也可以与前述示范例相同，即包括回收孔31以及回收通道32。在尖锐部21刺入目标斑块4的包壁41而进入目标斑块4的内部后，可通过在回收通道32近端抽吸的方式来吸取目标斑块4的内容物。
进一步的，本实施例还提供内容物回收机构3的另一优选示例，所述内容物回收机构3包括堵塞件34，所述堵塞件34具有选择性透过性，其允许透过尺寸不大于部分所述内容物的尺寸；所述堵塞件34被配置为在堵塞状态和第二收纳状态之间转换；所述堵塞件34处于所述堵塞状态时，用于封堵于所述目标斑块4的下游侧，以收集尺寸大于所述允许透过尺寸的所述内容物；所述堵塞件34处于所述第二收纳状态时，装载于所述导管1，并用于随所述导管1运动；其中，所述堵塞件34由所述堵塞状态转换至所述第二收纳状态的过程中，阻止所收集的所述内容物脱离所述堵塞件34。
可选的，堵塞件34包括可扩张收缩的弹性结构，该弹性结构例如为由镍钛丝编制的网格支撑物，由此堵塞件34能够收缩并被收纳入导管1，以随导管1一同移动而被输送入血管42。到达目标斑块4附近时，堵塞件34被驱动而伸出导管1的远端，进而堵塞件34扩张并堵塞在目标斑块4的下游。需要说明的，这里的下游，指沿着血管42内血液流向的下游侧。例如图9示出的示范例中，血液流向为由左至右，则堵塞件34位于目标斑块4的右侧。由于堵塞件34的弹性结构例如网格支撑物具有较大的空隙，进一步的，堵塞件34还包括半透膜，半透膜覆盖于弹性结构上。优选的，在堵塞件34扩张并堵塞在目标斑块4的下游时，半透膜与弹性结构能完全覆盖血管42的整个横截面。半透膜具有选择性透过性，其允许透过尺寸不大于部分所述内容物的尺寸。 并且，所述允许透过尺寸大于血细胞及其他血液物质的尺寸。这样该半透膜能允许血细胞及其他血液物质通过。在堵塞件34扩张并堵塞在血管42中时，目标斑块4中尺寸较大的能够形成血栓风险的内容物，能够被半透膜阻挡在血液流入的一侧，避免随血液循环而产生风险。
进一步的，堵塞件34由堵塞状态转换至第二收纳状态的过程中，能够阻止所收集的内容物脱离堵塞件34。一个示范例中，堵塞件34的弹性结构例如呈伞状，其在朝向近端移动而被收纳入导管1的过程中，不会使内容物脱离。
优选的，在图9和图10所示出的示范例中，尖锐部21可以呈刀片状，其不仅能够刺入目标斑块4，还可用于切割开包壁41，使目标斑块4中的内容物迅速流出至血管42中。
使用中，将导管1沿导丝输送至目标斑块4附近，导管1可以周向转动，并使导向管段572的远端切向正对目标斑块4。此时，驱动堵塞件34在目标斑块4的下游位置释放并转换至堵塞状态，以堵塞在血管42中，然后推送驱动丝与尖锐部21，使驱动丝与尖锐部21向前移动并沿在导向管段572的导引下伸出导管1，直到尖锐部21正对目标斑块4；此时操作尖锐部21使其划破目标斑块4的包壁41，并释放出目标斑块4中的内容物。内容物在血流作用下到达堵塞件34附近，在血液压力的作用下被半透膜阻挡而被堵塞件34收集。直到目标斑块4中的内容物被基本过滤并吸附在堵塞件34的半透膜表面时，可回收堵塞件34，使堵塞件34转换至第二收纳状态，将堵塞件34连同其过滤而收集的内容物一同装载进导管1并撤出体外。
可以理解的，包括堵塞件34的内容物回收机构3的优选示例，并非局限于应用在如图9和图10所示出的示范例中，其也可应用在如图2所示出的优选示例中。此外，内容物回收机构3不局限于仅包括堵塞件34或回收孔31中的一种，也可以是两者并用，例如在图2示出的示范例中，还可以结合堵塞件34的方案，这样一旦少量内容物被挤压时从包壁41处泄漏出来，也可以被堵塞件34所回收，提高了可靠性和安全性。
综上所述，在本发明提供的斑块治疗装置包括导管、斑块破坏机构及内容物回收机构；所述斑块破坏机构被配置为在执行状态和第一收纳状态之间 转换；其中，处于所述第一收纳状态的所述斑块破坏机构装载于所述导管，并用于随所述导管运动；处于所述执行状态的所述斑块破坏机构用于破坏目标斑块的包壁，所述内容物回收机构用于回收所述目标斑块的内容物。如此配置，斑块破坏机构能够用于以物理的方式破坏目标斑块的包壁，进而目标斑块的内容物能够被内容物回收机构回收，不会随血液循环造成危害。对于易损斑块是一种机械性的治疗方式，其优势在于能够快速解决根本问题，实现精准治疗，达到快速而彻底治疗易损斑块的目的。
需要说明的，上述若干实施例之间可相互组合。上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (13)

  1. 一种斑块治疗装置，其特征在于，包括：导管、斑块破坏机构及内容物回收机构；所述斑块破坏机构被配置为在执行状态和第一收纳状态之间转换；
    其中，处于所述第一收纳状态的所述斑块破坏机构装载于所述导管，并用于随所述导管运动；处于所述执行状态的所述斑块破坏机构用于破坏目标斑块的包壁，所述内容物回收机构用于回收所述目标斑块的内容物。
  2. 根据权利要求1所述的斑块治疗装置，其特征在于，还包括驱动机构；所述驱动机构用于驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换；所述斑块破坏机构包括与所述驱动机构连接的尖锐部，所述斑块破坏机构自所述第一收纳状态向所述执行状态转换时，所述尖锐部相对所述导管沿径向伸出，用于刺破所述目标斑块的包壁。
  3. 根据权利要求2所述的斑块治疗装置，其特征在于，所述驱动机构包括滑块及连杆，所述连杆的一端与所述滑块连接，所述连杆的另一端与所述斑块破坏机构连接；所述滑块用于沿所述导管的轴向移动，以通过所述连杆驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换。
  4. 根据权利要求3所述的斑块治疗装置，其特征在于，所述驱动机构包括沿所述导管的轴向设置的滑块容置腔及驱动流体通道，所述滑块的径向外轮廓形状与所述滑块容置腔的径向内轮廓形状相适配，所述滑块沿轴向可移动地设置于所述滑块容置腔内；所述驱动流体通道与所述滑块容置腔连通，所述驱动流体通道用于供驱动流体注入所述滑块容置腔，或自所述滑块容置腔吸取所述驱动流体，以驱使所述滑块沿轴向移动。
  5. 根据权利要求3所述的斑块治疗装置，其特征在于，所述驱动机构包括沿所述导管的轴向设置的螺纹驱动件，所述滑块与所述螺纹驱动件螺纹连接，所述螺纹驱动件用于自转，以驱动所述滑块沿轴向移动。
  6. 根据权利要求3～5中任一项所述的斑块治疗装置，其特征在于，所述驱动机构包括两个沿轴向间隔布置的滑块以及至少两个连杆；每个所述滑块 与至少一个所述连杆连接；两个所述滑块被配置为同步地沿相反的方向移动。
  7. 根据权利要求3所述的斑块治疗装置，其特征在于，所述斑块破坏机构包括设置于所述导管外的扩展基体，所述扩展基体沿所述导管的轴向延伸，所述尖锐部设置于所述扩展基体上，所述扩展基体与所述连杆的另一端连接，所述扩展基体用于在所述连杆的驱动下沿径向移动；其中，所述斑块破坏机构处于所述第一收纳状态时，所述扩展基体贴靠于所述导管的外壁；所述斑块破坏机构处于所述执行状态时，所述扩展基体沿径向远离所述导管，并用于挤压所述目标斑块的包壁。
  8. 根据权利要求1所述的斑块治疗装置，其特征在于，还包括驱动机构；所述驱动机构用于驱动所述斑块破坏机构在所述执行状态和所述第一收纳状态之间转换；所述斑块破坏机构包括与所述驱动机构连接的尖锐部；所述驱动机构包括驱动丝及导引件，所述驱动丝与所述尖锐部连接；所述导引件用于导引和改变所述驱动丝的延伸方向；其中，所述斑块破坏机构处于所述第一收纳状态时，所述尖锐部不超出所述导引件和所述导管中更靠外的一者；所述斑块破坏机构自所述第一收纳状态向所述执行状态转换时，所述尖锐部在所述驱动丝的驱动下沿与所述导管的轴向成角度的方向伸出所述导引件和所述导管，用于刺破所述目标斑块的包壁。
  9. 根据权利要求8所述的斑块治疗装置，其特征在于，所述导引件包括弧形延伸的导向管段，所述导向管段的近端切向沿所述导管的轴向延伸，所述导向管段的远端切向与所述导管的轴向成角度延伸并穿透所述导管的外壁；所述导向管段用于供所述驱动丝可活动地穿设，并用于导引和改变所述驱动丝的延伸方向。
  10. 根据权利要求1所述的斑块治疗装置，其特征在于，所述内容物回收机构包括堵塞件，所述堵塞件具有选择透过性，其允许透过尺寸不大于部分所述内容物的尺寸；所述堵塞件被配置为在堵塞状态和第二收纳状态之间转换；
    所述堵塞件处于所述堵塞状态时，用于封堵于所述目标斑块的下游侧，以收集尺寸大于所述允许透过尺寸的所述内容物；
    所述堵塞件处于所述第二收纳状态时，装载于所述导管，并用于随所述导管运动；
    其中，所述堵塞件由所述堵塞状态转换至所述第二收纳状态的过程中，阻止所收集的所述内容物脱离所述堵塞件。
  11. 根据权利要求1所述的斑块治疗装置，其特征在于，所述斑块破坏机构包括尖锐部，所述内容物回收机构包括沿所述尖锐部的轴向贯通开设于所述尖锐部上的回收孔，还包括沿所述导管的轴向延伸设置的回收通道，所述回收孔与所述回收通道连通；所述回收通道和所述回收孔用于供抽吸出所述目标斑块的内容物。
  12. 根据权利要求11所述的斑块治疗装置，其特征在于，所述内容物回收机构还包括多个旁支孔，所述旁支孔沿所述尖锐部的径向开设于所述尖锐部的侧壁，并与所述回收孔连通；所述旁支孔允许所述目标斑块的内容物通过。
  13. 根据权利要求1所述的斑块治疗装置，其特征在于，所述导管为多腔管。
PCT/CN2023/118460 2022-11-23 2023-09-13 斑块治疗装置 Ceased WO2024109274A1 (zh)

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