WO2024055927A1 - 医疗导管 - Google Patents

医疗导管 Download PDF

Info

Publication number
WO2024055927A1
WO2024055927A1 PCT/CN2023/117991 CN2023117991W WO2024055927A1 WO 2024055927 A1 WO2024055927 A1 WO 2024055927A1 CN 2023117991 W CN2023117991 W CN 2023117991W WO 2024055927 A1 WO2024055927 A1 WO 2024055927A1
Authority
WO
WIPO (PCT)
Prior art keywords
imaging
component
bending
distal
electrode
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/CN2023/117991
Other languages
English (en)
French (fr)
Inventor
周奇
张正海
岳斌
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 EP23864659.0A priority Critical patent/EP4588427A4/en
Publication of WO2024055927A1 publication Critical patent/WO2024055927A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • 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
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00096—Optical elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00101—Insertion part of the endoscope body characterised by distal tip features the distal tip features being detachable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112—Connection or coupling means
    • A61B1/00121—Connectors, fasteners and adapters, e.g. on the endoscope handle
    • A61B1/00128—Connectors, fasteners and adapters, e.g. on the endoscope handle mechanical, e.g. for tubes or pipes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00158—Holding or positioning arrangements using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00165—Optical arrangements with light-conductive means, e.g. fibre optics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0052—Constructional details of control elements, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0057—Constructional details of force transmission elements, e.g. control wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/042—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by a proximal camera, e.g. a CCD camera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/128—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for regulating temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3137—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for examination of the interior of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • 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
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • 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
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0158—Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00172—Connectors and adapters therefor
    • A61B2018/00178—Electrical connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/0072—Current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00732—Frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0141—Tip steering devices having flexible regions as a result of using materials with different mechanical properties

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a medical catheter that integrates diagnosis and treatment and is controllably bendable.
  • Atherosclerosis is a syndrome affecting arterial blood vessels. Atherosclerosis results in a chronic inflammatory response in the walls of arteries, mostly due to the accumulation of lipids, macrophages, foam cells, and the formation of plaque in the arterial walls. Atherosclerosis is commonly referred to as arteriosclerosis, and the pathophysiology of the disease manifests itself in several different types of lesions, ranging from fibrotic to lipid-laden to calcified. At present, the main mature clinical treatments for atherosclerosis include drugs, interventional and bypass surgery, but there are still problems such as long-term restenosis and thrombosis.
  • Thermal physical therapy has been widely used in clinical practice due to its relatively low cost, few side effects and short treatment time. Thermal physical therapy is achieved through thermal ablation.
  • the energy generation methods for thermal ablation mainly include cryoballoon, focused ultrasound, laser and radio frequency.
  • Clinical studies have shown that radiofrequency ablation has the advantages of a certain safe frequency, controllable thermal energy output and easier functional integration.
  • thermal physical therapy a certain range of tissue damage is required to ensure the ablation effect, but there is currently no relevant technical means to accurately monitor and control the ablation range of fibrous plaques.
  • Intravascular imaging technologies mainly include OCT (optical coherence tomography), IVUS (intravascular ultrasound imaging), angioscopy, and intravascular MRI.
  • OCT technology has obvious advantages in imaging resolution (resolution is better than 10 ⁇ m) and can obtain high-definition images of biological tissues, which is very conducive to accurate imaging and identification of intravascular plaques.
  • diagnosis and treatment processes are usually separated. Therefore, imaging catheters and ablation catheters need to be replaced frequently, which not only increases the overall treatment cost, but also cannot provide timely treatment. In some cases, it still has a high cost. recurrence rate.
  • the ablation catheter often adheres poorly to the tissue (lesion), resulting in poor treatment effects or even failure.
  • the object of the present invention is to provide a medical catheter to solve the problem of poor adhesion between the catheter and the target tissue during the treatment process in the prior art, resulting in poor therapeutic effect or even surgical failure, and to solve the problem of separation of the diagnosis and treatment processes at the same time. problems arise.
  • the present invention provides a medical catheter, which includes a catheter body and a bend control component.
  • the catheter body includes a proximal part and a distal part located at the distal end of the catheter body.
  • the distal part is For imaging monitoring, it is also used to release therapeutic energy and/or therapeutic agents.
  • the distal part is connected to the bending control component and is used to bend relative to the proximal part under the control of the bending control component.
  • the distal portion further includes a distal tube body
  • the proximal portion includes a proximal tube body
  • the hardness of the distal tube body is less than the hardness of the proximal tube body
  • the bending control component includes a bending traction body and a bending control component.
  • the bending control component is disposed at the proximal end of the catheter body.
  • the distal end of the bending traction body is in contact with the distal end.
  • the proximal end of the bending traction body passes through the catheter body and is connected to the bending control part.
  • the bending traction body is used to control the distal part driven by the bending control part. bending.
  • the number of the bending traction bodies is multiple, and the plurality of bending traction bodies are evenly distributed in the circumferential direction around the central axis of the catheter body.
  • each of the bending traction bodies is connected to at least one of the bending control parts, and different bending traction bodies are connected to different bending control parts.
  • the medical catheter further includes an interface portion, and the proximal end of the proximal portion is connected to the interface portion,
  • the bending control part is movably arranged on the interface part.
  • the catheter body further includes an axially extending bending control channel, and the bending traction body passes through the bending control channel.
  • the bending control component includes a magnetically responsive deformation component and/or a photoinduced deformation component.
  • the magnetically responsive deformation component is made of magnetically responsive material and can deform under the action of a magnetic field.
  • the photoinduced deformation component The components are made of photoresponsive materials that can photo-induced deformation after absorbing light energy.
  • the medical catheter further includes an interface portion, the proximal end of the proximal portion is connected to the interface portion, and the interface portion is used to connect with a corresponding external device to input and output information.
  • the distal portion includes an imaging diagnostic component for imaging monitoring and a treatment component for releasing therapeutic energy and/or therapeutic agents;
  • the imaging diagnostic component includes an imaging probe, and the catheter body also includes an axially extending imaging channel.
  • An imaging transmission structure connected to the imaging probe is provided in the imaging channel, and the central axis of the imaging channel is aligned with the imaging probe.
  • the central axes of the catheter bodies coincide with each other.
  • the distal portion further includes an imaging window, and the imaging probe is disposed at the imaging window.
  • the imaging probe is an optical probe.
  • the imaging transmission structure includes an imaging fiber, a protective tube and a torsion spring.
  • the protective tube is sleeved on the imaging fiber, and the torsion spring is provided on the imaging fiber. Between the protective tube and the imaging optical fiber, one end of the imaging optical fiber is connected to the imaging probe, and the other end extends along the imaging channel to the proximal end of the catheter body.
  • the medical catheter further includes an interface portion, the proximal end of the proximal portion is connected to the interface portion, the interface portion includes an imaging interface and a mechanical power transmission interface, and the other end of the imaging optical fiber One end is connected to the mechanical power transmission interface and the imaging interface, and the imaging diagnostic component is used to rotate along the circumferential direction of the catheter body and/or move along the axial direction of the catheter body driven by a driving device.
  • the treatment component includes an energy output component capable of outputting at least one treatment energy of radio frequency, ultrasound, laser, and cryogenic fluid, and/or the treatment component includes a therapeutic agent output component, the therapeutic agent output component includes at least one of a drug coating and a drug release structure, the drug release structure includes a drug delivery hole and/or a drug delivery microneedle.
  • the treatment component includes the energy output component, the energy output component includes an electrode, and the distal part further includes a temperature measurement component disposed on the electrode, and the temperature measurement component is used to Get the electrode surface temperature.
  • the catheter body further includes an axially extending temperature control fluid channel
  • the distal part further includes a temperature control fluid output hole
  • the temperature control fluid output hole is provided on the electrode, so The distal end of the temperature control fluid channel is connected to the temperature control fluid output hole, and the temperature control fluid channel is used to transport temperature control fluid.
  • the catheter body further includes an axially extending temperature control wire channel and an electrode wire channel
  • the temperature measurement component is connected to the distal end of the temperature control wire, and the proximal end of the temperature control wire passes through
  • the temperature control wire channel extends to the proximal end of the catheter body;
  • the electrode is connected to the distal end of the electrode wire, and the proximal end of the electrode wire passes through the electrode wire channel and extends to the catheter body. near end.
  • the energy output component includes electrodes, the electrodes are used to output radio frequency, and the number of the electrodes is multiple and arranged at intervals along the axial direction and/or circumferential direction of the catheter body.
  • the distal end of the distal part is connected to a head end through an elastic connection part, and the head end is provided with a guidewire lumen.
  • the medical catheter provided by the technical solution of the present invention has at least the following beneficial effects:
  • the medical catheter of the present invention has a distal part, which can be used for imaging monitoring and releasing therapeutic energy and/or therapeutic agents, so that the medical catheter realizes the integration of diagnosis and treatment, and the distal part can be Bending under the control of bending control components.
  • the present invention does not need to replace the imaging catheter and the imaging catheter when performing interventional treatment on the lesion.
  • the treatment catheter eliminates the need for frequent catheter replacement, which not only simplifies the surgical process, but also avoids the difficulty of repositioning the catheter after replacing different catheters, ensuring the positioning accuracy of the catheter during the treatment process.
  • the distal part can monitor the treatment effect in real time, which is conducive to accurately regulating the output of treatment energy and/or therapeutic agents.
  • the bending angle of the distal part can be adjusted at any time. It ensures that the distal part and the lesion are always in good contact, and ultimately achieves the purpose of precise targeted treatment of the lesion, improves the treatment effect, improves the success rate of the operation, and shortens the operation time.
  • the bending control function of the medical catheter allows the catheter to be adapted to the treatment of lesions of different shapes, making it more flexible and convenient to use, and has a wider range of applications. Therefore, the medical catheter of the present invention can achieve precise treatment of the lesion, simplify the treatment steps, and facilitate the operation of medical staff.
  • the medical catheter of the present invention can be reused during the treatment process until the treatment is complete, saving material consumption, which is conducive to reducing the incidence of complications after current interventional operations, improving clinical treatment effects, reducing re-hospitalization rates, and reducing disease-related complications. family burden and social and economic losses, and has good economic and ecological benefits.
  • Figure 1 is a schematic diagram of the overall structure of a medical catheter in one embodiment of the present invention.
  • Figure 2 is a detailed structural diagram of a medical catheter in an embodiment of the present invention.
  • FIG. 3 is a detailed structural schematic diagram of the medical catheter in Embodiment 1 of the present invention when a bending control component is provided;
  • Figure 4 is a partial enlarged view of the medical catheter at position a in Figure 3;
  • Figure 5a is a cross-sectional view of the structure in Figure 4 along line A-A;
  • Figure 5b is a cross-sectional view of the structure in Figure 4 along the line B-B;
  • Figure 5c is a cross-sectional view of the structure in Figure 4 along the line C-C;
  • FIG6 is a diagram showing a use scenario of a medical catheter in one embodiment of the present invention being delivered to a blood vessel along a guide wire through a guide wire lumen on a head end;
  • Figure 7 is a usage scenario diagram of a medical catheter in an embodiment of the present invention in which the distal end portion is bent relative to the proximal end portion so that the distal end portion is close to the lesion (fibrous plaque).
  • 10-Medical catheter 1-Interface part; 11-Fluid perfusion interface; 12-Imaging interface; 13-Electrical signal interface; 14-Mechanical power transmission interface; 2-Catheter body; 21-Imaging channel; 22-Temperature control fluid channel ; 23-temperature control wire channel; 24-electrode wire channel; 25-bend control channel; 210-proximal part; 220-distal part; 221-treatment component; 222-imaging diagnostic component; 2221-imaging probe; 2222- Imaging transmission structure; 223-imaging window; 224-temperature-controlled fluid output hole; 225-proximal electrode; 226-distal electrode; 3-head end; 31-guidewire cavity; 4-bending control component; 41-bending adjustment Traction body; 42-bending control piece; 5-connection part; 6-temperature control wire; 7-electrode wire; 20-fibrous plaque; 30-guiding wire.
  • distal and proximal are used for ease of description; “distal” is the side away from the operator of the medical catheter; “proximal” It is the side of the operator close to the medical catheter; “axial” refers to the direction along the central axis of the medical catheter; “circumferential” refers to the direction around the central axis of the medical catheter; “central axis” refers to the direction of the medical catheter. The length direction of the catheter; “radial” refers to the diameter direction of the medical catheter.
  • one embodiment of the present invention provides a medical catheter 10 that integrates diagnosis and treatment, and the distal end of the medical catheter 10 can be bent.
  • the medical catheter 10 provided in this embodiment is not limited to intravascular interventional treatment, but can also be used for interventional treatment in non-vascular lumen such as the esophagus, prostate duct, intestine, etc.
  • the medical catheter 10 involved in this embodiment is used to intervene in coronary blood vessels for treatment, such as treating atherosclerosis and other diseases, and has good therapeutic effects.
  • medical catheter 10 includes catheter body 2 .
  • the catheter body 2 includes a proximal portion 210 and a distal portion 220 located at the distal end of the catheter body 2 .
  • the distal portion 220 can achieve imaging monitoring within the target lumen and can also release therapeutic energy and/or therapeutic agents to the target location within the target lumen.
  • the target lumen refers to a blood vessel or a non-vascular lumen.
  • the type of treatment energy is not limited. For example, it may be at least one of radio frequency, ultrasound, laser and freezing fluid.
  • the therapeutic agents are mainly drugs.
  • the medical catheter 10 according to the embodiment of the present application further includes a bending control component 4 .
  • the bend control component 4 is at least partially disposed in the catheter body 2 .
  • the distal portion 220 is connected to the bending control component 4 and used to bend relative to the proximal portion 210 under the control of the bending control component 4 .
  • the medical catheter 10 of the present invention has the functions of both an imaging catheter and a treatment catheter, realizing the integration of diagnosis and treatment.
  • the imaging catheter and the treatment catheter When performing interventional treatment on the lesion, there is no need to replace the imaging catheter and the treatment catheter, thereby eliminating the need for It not only simplifies the operation process of exchanging catheters, but also avoids the difficulty of re-finding a treatment site after exchanging different catheters.
  • the distal part 220 can also monitor the treatment effect in real time to accurately target the treatment focus and improve the accuracy and effectiveness of the treatment.
  • the bending control component 4 can adjust the bending angle of the distal part 220 at any time, so that the distal part 220 is always in close contact with the lesion, thereby accurately aligning the lesion, and ultimately achieving precise targeting of the lesion. treatment will significantly improve the treatment effect and increase the success rate of surgery.
  • This application does not limit the bending angle of the distal part 220, for example, it may be less than or equal to 90° or greater than 90° and less than 180°.
  • the bending angle of the distal portion 220 can be set according to actual requirements.
  • the distal portion 220 can use one or more imaging methods to achieve imaging monitoring of the target lumen, such as at least one imaging method among optical imaging and ultrasound imaging, preferably OCT optical coherence tomography.
  • OCT has the highest imaging resolution, which is beneficial to the imaging and resolution of intravascular plaques.
  • the distal portion 220 can release one or more therapeutic energies, such as at least one of radio frequency, ultrasound, laser, and cryogenic fluid.
  • the distal portion 220 may use one or more means to release the therapeutic agent to the target location.
  • the therapeutic agent is preferably a drug things.
  • the invention does not limit the types of drugs.
  • the drugs can be selected according to needs, such as anti-proliferation, anti-proliferation, anti-restenosis, anti-inflammatory, antibacterial, anti-tumor, anti-mitosis, anti-metastasis, Antithrombotic, anti-osteoporotic, anti-angiogenic, cytostatic, microtubule-inhibiting drugs.
  • distal portion 220 includes a treatment component 221 and an imaging diagnostic component 222 .
  • the treatment component 221 is used to release at least one of treatment energy and treatment agent to the target location (including lesions, such as fibrous plaques).
  • the treatment component 221 can output at least one treatment energy from radio frequency, ultrasound, laser, and cryogenic fluid, and/or the treatment component 221 uses one or more structures to release therapeutic agents to the target location.
  • the imaging diagnosis component 222 is used to image the lesion area, so as to facilitate the identification of the location and components of the lesion before treatment, and also facilitate the monitoring of the treatment effect or the release degree of the therapeutic agent during the treatment process. It also facilitates the operation of the lesion area after the treatment is completed. Imaging scans evaluate treatment effectiveness. This application does not limit the imaging method of the imaging diagnostic component 222 .
  • the imaging diagnostic component 222 may be optical imaging or ultrasound imaging, preferably OCT imaging.
  • the distal part 220 further includes a distal tube body, and the proximal part 210 includes a proximal tube body.
  • the treatment component 221 is arranged on the distal tube body. Imaging diagnostic component 222 is disposed in the distal tube body. If the treatment component 221 includes electrodes, the electrodes are disposed on the outer peripheral surface of the distal tube body. If the treatment component 221 includes a drug administration hole, the drug administration hole is provided on the outer peripheral surface of the distal tube body and penetrates the tube wall. For another example, when the treatment component 221 includes a drug coating, the drug coating covers the outer peripheral surface of the distal tube body.
  • the distal tube body itself can form a treatment component 221, such as a drug delivery hole, a drug delivery microneedle, etc., so that the treatment component 221 and the distal tube body can be integrated into one body, or can be additionally provided on the distal tube body.
  • the proximal tube body and the distal tube body can be processed and formed independently and then assembled, and the proximal tube body and the distal tube body can also be processed and formed in one piece without assembly.
  • the hardness of the distal tube body is smaller than the hardness of the proximal tube body, making the entire distal tube body softer and easier to control bending, while the overall proximal tube body is harder and easier to push and manipulate.
  • the proximal end of the distal tube body and the distal end of the proximal tube body can be connected in a separate manner or in an integrated manner.
  • the distal tube body and the proximal tube body are both made of polyamide materials such as nylon, PEBAX, etc., and the proximal tube body is configured as a multi-layer tube structure, such as an inner tube At least one metal layer (such as a braided tube or a reed tube) is added between the proximal portion 210 and the outer tube to increase the strength or stiffness of the proximal portion 210 .
  • the proximal tube body and the distal tube body can also be made of materials with different hardnesses.
  • the bending control component 4 includes a bending traction body 41 and a bending control part 42 .
  • the bending control part 42 is provided at the proximal end of the catheter body 2 .
  • the distal end of the bending traction body 41 is connected to the distal part 220 , and the proximal end of the bending traction body 41 passes through the catheter body 2 and is connected to the bend control member 42 .
  • the bending traction body 41 is used to control the bending of the distal portion 220 under the driving of the bending control member 42 .
  • the number of the bending traction bodies 41 may be one or more, usually multiple. When the number of the bending traction bodies 41 is multiple, it may be 2 or more than 2.
  • the number of the bending traction bodies 41 is mainly an even number, such as 2, 4, 6 or more.
  • a plurality of bending traction bodies 41 are evenly arranged in the circumferential direction around the central axis of the catheter body 2 to facilitate 360° all-round bending, making bending more flexible and convenient, and having a wider application range.
  • the number of the bending traction bodies 41 is set to four or six, which can meet actual diagnosis and treatment needs.
  • the bending traction body 41 is preferably made of a material with long life, good recovery, high repeated bending accuracy, and high yield strength, such as nickel-titanium alloy, stainless steel and other metal materials.
  • the bending traction body 41 may be any suitable structure such as a pull rope, a wire, or a rod-shaped structure.
  • the bending traction body 41 is preferably a wire material, such as a round wire material, with a diameter of 0.01 mm to 0.2 mm. This diameter will not increase the overall size of the medical catheter while ensuring that the wire material will not be easily broken. .
  • Different bending traction bodies 41 are controlled by different bending control parts 42, but the number of bending control parts 42 and the number of bending traction bodies 41 may be consistent or inconsistent.
  • one bending control part 42 can control one bending traction body at the same time. body 41, or multiple bending control parts 42 simultaneously control one bending traction body 41.
  • a plurality of bending control parts 42 are connected to a plurality of bending traction bodies 41 in a one-to-one correspondence, so that each bending traction body 41 is controlled by a corresponding bending control part 42.
  • the bending control part 42 can be a bending control knob or a bending control moving part, and can release or tighten the bending traction body 41 by rotating or moving.
  • the medical catheter 10 further includes an interface portion 1 , the proximal end of the proximal portion 210 is connected to the interface portion 1 , and the bending control member 42 is movably provided on the interface portion 1 .
  • “moveably provided” means that the bending control member 42 is provided on the interface portion 1 but can rotate or move relative to the interface portion 1 .
  • the interface part 1 can be eliminated.
  • the bending control component 4 may be a magnetically responsive deformation component disposed in the distal tube body.
  • the magnetically responsive deformation component is made of magnetically responsive material and can deform under the action of an external magnetic field to complete the bending movement. This causes the distal portion 220 to bend relative to the proximal portion 210 . Moreover, after the magnetic field disappears, the magnetically responsive deformation component can return to its original state, thus causing the distal portion 220 to return to its original state.
  • the magnetically responsive deformation component is made of a polymer material compounded with magnetically responsive particles (such as ferric oxide or neodymium iron boron, etc.).
  • the magnetically responsive deformation component produces deformation in different directions and to varying degrees, thereby driving the distal portion 220 to bend at a certain angle.
  • the bending control component 4 can be a photo-induced deformation component disposed in the distal tube body.
  • the photo-induced deformation component is made of a photo-responsive material and can generate photo-induced deformation after absorbing light energy to complete the bending movement. , thereby causing the distal portion 220 to bend relative to the proximal portion 210 .
  • the photodeformation component is a strip-shaped photosensitive element.
  • the strip-shaped photosensitive element is pasted in the distal tube body. The photo-induced deformation of the strip-shaped photosensitive element causes the distal portion 220 to bend relative to the proximal portion 210 .
  • the photodeformable component can return to its original shape, thereby restoring the distal portion 220 to its original state.
  • the photodeformable component is made of photodeformable materials (such as azobenzene polymers, PLTZ ceramics), and is made into a strip structure, which is attached to the distal tube body, and the illumination component in the medical catheter 10 Under irradiation, deformation occurs at a specific irradiation position, thereby driving the distal portion 220 to bend at a certain angle.
  • the bending control component 4 that occupies a small space is used to realize the bending of the distal portion 220 .
  • the bending control component 4 can adopt one or more of the above structures to achieve bending control.
  • the bending control method of the bending traction body 41 has a simpler structure, is relatively easy to implement in terms of technology, and occupies a relatively small space, which is beneficial to controlling the overall size of the medical catheter 10 .
  • the bending control member 42 when the distal part 220 is transported to the designated lesion location, the bending control member 42 can be used to pull the bending traction body 41 to drive the distal part 220 to bend at a certain angle to adapt to the shape of different lesions. Improve fit and treatment effectiveness.
  • the bending control member 42 adjusts the distal portion 220 to form a bending angle of 0° to 90° to achieve conformal fit of the ablation lesion.
  • Conformable here refers to adjusting the bending angle according to the shape of the lesion so that the distal part 220 is in good contact with the lesion.
  • an independent bending control channel 25 (see Figure 5a) is provided in the catheter body 2 for the bending traction body 41 to pass through.
  • the bending control channel 25 can be eliminated, and the bending traction body 41 can be shared with other channels to reduce the number of channels and control the overall size of the medical catheter 10 .
  • the four bending traction bodies 41 are correspondingly provided with four bending control channels 25, and the four bending control channels 25 surround the catheter body 2.
  • the central axes are staggered by 90°, and each bending control channel 25 is only capable of passing through one bending traction body 41.
  • the distal end of the bending traction body 41 is preferably disposed on the proximal side of the imaging diagnostic component 222, specifically disposed on the proximal side of the imaging probe 2221 described below, to avoid the imaging probe 2221, reduce the impact on imaging, and ensure imaging quality.
  • the connection position between the bending traction body 41 and the distal part 220 can be set according to the bending control angle.
  • the proximal end of the proximal part 210 is connected to the interface part 1 , and the interface part 1 is used to connect with external devices to input and output information.
  • the external device may be an imaging system, an energy output system, a fluid perfusion device, a driving device, etc.
  • the information input and output by the interface unit 1 at least includes energy, and the energy at least includes energy for imaging, such as light energy or electrical energy.
  • the interface part 1 includes several interfaces. The number and type of interfaces depend on the remote part. 220's own function settings.
  • the distal end of the distal portion 220 is connected to the head end 3 through the connecting portion 5 .
  • the connecting part 5 serves as a physical end and connects the distal part 220 and the head end 3 .
  • the connecting part 5 is a solid body, which can further seal the distal end of the distal tube body and realize the connection between the distal part 220 and the head end 3 .
  • the connecting portion 5 is made of elastomer to reduce the risk of damage to the head end 3 .
  • the material of the connecting part 5 can be polyurethane or silicone.
  • the diameter of the connecting portion 5 is consistent with the diameter of the catheter body 2 .
  • the length of the connecting portion 5 should not be too long or too short; if it is too long, the pushing performance of the medical catheter 10 will be reduced; if it is too short, the protection effect on the head end 3 will be limited.
  • the axial length of the connecting portion 5 is 1 mm to 10 mm.
  • the head end 3 is a tapered head, which is usually soft and has a damage-free structure, which can reduce damage to blood vessels or tissues.
  • the head end 3 is preferably provided with a guide wire lumen 31 for the guide wire to pass through to achieve rapid exchange.
  • the front placement of the guidewire cavity 31 makes it easier to replace and operate the medical catheter 10 without affecting the overall size of the medical catheter 10 .
  • the diameter of the guide wire cavity 31 should be set in combination with the diameter of the guide wire.
  • the diameter of the guide wire cavity 31 is 0.1 mm to 2 mm.
  • the size of the head end 3 should not be too large, otherwise it will be difficult to pass through the stenotic lesion. Therefore, the size of the head end 3 should be small.
  • the head end 3 is not likely to be too long. If it is too long, the head end 3 will be sharp and may damage blood vessels or tissues. If the head end 3 is too short, the crossing performance will be affected.
  • the axial length of the head end 3 is 5.0 mm to 50 mm, preferably 20 mm.
  • the imaging diagnostic component 222 includes an imaging probe 2221 , and the imaging probe 2221 transmits imaging energy and collected signals through an imaging transmission structure 2222 .
  • one end of the imaging transmission structure 2222 is connected to the imaging probe 2221, and the other end is connected to the interface part 1 after passing through the distal part 220 and the proximal part 210.
  • the imaging probe 2221 includes but is not limited to structures such as microlenses (light gathering components), ultrasonic probes, and light reflecting mirrors.
  • the imaging probe 2221 may use at least one of a microlens, an ultrasonic probe, and a light reflector. That is, the imaging method of the imaging diagnosis component 222 may be one or a combination of two or more.
  • the imaging diagnostic component 222 adopts OCT imaging, which uses ultra-low propagation loss and extremely low diameter (such as 200 ⁇ m) imaging optical fiber as the light guide medium, and uses a microlens at the distal end of the imaging optical fiber as the imaging probe 2221.
  • Microlenses can be light focusing components.
  • the light focusing component may be a ball lens or a gradient index lens. Since the optical fiber itself is made of glass filaments and is very brittle, it can easily break if not protected during use. Therefore, the entire imaging optical fiber is encapsulated in a protective tube to form a conductive optical cable to avoid damage during the movement of the optical elements and the remote light focusing assembly. Mechanical damage, and better tensile and bending resistance.
  • the protective tube may be a transparent tube.
  • the catheter body 2 also includes an imaging channel 21 for accommodating the imaging transmission structure 2222.
  • the imaging channel 21 extends along the axial direction of the catheter body 2.
  • the central axis of the imaging channel 21 is preferably coincident with the central axis of the catheter body 2 , that is, the imaging channel 21 is at the center of the medical catheter 10 .
  • Such an arrangement facilitates the arrangement of channels with other functions on the periphery of the imaging channel 21, so that the internal space of the catheter body 2 can be effectively utilized, and while ensuring that the catheter body 2 has sufficient strength, it avoids increasing the outer diameter of the medical catheter to facilitate intervention. treatment in small blood vessels.
  • distal portion 220 also includes an imaging window 223.
  • the imaging probe 2221 is provided at the imaging window 223.
  • Imaging window 223 is preferably transparent.
  • the imaging window 223 facilitates the imaging probe 2221 to emit and receive light beams.
  • the axial length of the imaging window 223 and the axial length of the distal tube body can be equal, that is, the entire distal tube body can be set as a transparent part.
  • the axial length of the distal tube body is greater than the axial length of the imaging window 223, that is, the distal tube body part is set as a transparent part.
  • the axial length of the imaging window 223 is 2 mm to 100 mm.
  • the axial length of the imaging window 223 can be defined as the axial length extending from the proximal end of the connecting portion 5 toward the direction of the catheter body 2 .
  • the material for preparing the transparent part in the distal tube body may be transparent nylon or the like.
  • the proximal portion 210 is typically made of an opaque material, such as polyamide. It should be noted that if optical imaging is not used, the imaging window 223 can be eliminated.
  • the imaging diagnosis component 222 adopts optical imaging.
  • the imaging transmission structure 2222 includes an imaging optical fiber, and the imaging probe 2221 is an optical probe.
  • the imaging transmission structure 2222 also includes a protective tube and a torsion spring.
  • the protective tube is sleeved on the imaging fiber.
  • the torsion spring is arranged between the protection tube and the imaging fiber. described as One end of the optical fiber is connected to the imaging probe 2221, and the other end is connected to the interface part 1.
  • the setting of the torsion spring can better conduct the torsion, so as to smoothly drive the imaging fiber and the imaging probe 2221 at the distal end of the imaging fiber to move.
  • the interface part 1 includes an imaging interface 12 and a mechanical power transmission interface 14.
  • the other end of the imaging fiber is connected to the mechanical power transmission interface 14 and the imaging interface 12, so that the imaging diagnostic component 222 is
  • the external driving device is driven to rotate in the circumferential direction of the catheter body 2 and/or to move in the axial direction of the catheter body 2 .
  • the mechanical power transmission interface 14 can be integrated with the imaging interface 12 or the two can be provided separately and independently.
  • the driving device drives the imaging transmission structure 2222 and the imaging probe 2221 to move and rotate through the mechanical power transmission interface 14 .
  • the driving device may be a motor.
  • the treatment component 221 includes an energy output component for outputting treatment energy.
  • the energy output component can output at least one treatment energy among radio frequency, ultrasonic wave, laser and freezing fluid.
  • the energy output component may be at least one of an electrode, an ultrasonic transducer, a laser focusing lens, and a freezing fluid channel. That is, the therapeutic energy output by the energy output component may be one type or a combination of two or more types of therapeutic energy.
  • the electrodes are used to output radio frequencies.
  • the ultrasonic transducer is used to generate ultrasonic waves.
  • the laser focusing lens is used to output laser light.
  • the cryofluid channel is used to seal in the medical catheter 10 and perform cryoablation by conducting energy.
  • treatment component 221 includes a therapeutic agent output component for releasing therapeutic agent to a target location.
  • the therapeutic agent output component may be any suitable structure, for example, the therapeutic agent output component may include at least one of a drug coating and a drug release structure.
  • the drug release structure includes drug delivery holes and/or drug delivery microneedles. It should be understood that the drug administration microneedles are arranged on the outer peripheral surface of the distal tube body, and the drug can be stored in advance, or the drug can be administered through the drug administration channel.
  • the drug coating is provided on the outer peripheral surface of the distal tube body.
  • the drug administration hole is provided on the outer peripheral surface of the distal tube body and penetrates the tube wall to communicate with the drug administration channel.
  • the therapeutic agent output component may release therapeutic agents in one way or in a combination of two or more, such as providing both a drug coating and a drug release structure. It should be noted that the energy output component and the therapeutic agent output component can be set at the same time or alternatively.
  • the distal part 220 preferably also includes a temperature measurement component (not shown), which is used to obtain the surface temperature of the target tissue (such as ablation tissue) during the energy treatment process to ensure appropriate energy output. Since the temperature measurement component can obtain more accurate temperature information of the lesion, the treatment effect is improved.
  • the temperature measuring component can be any suitable structure, such as a thermocouple, a thermistor or a thermal signal collection lens.
  • the temperature measuring component may adopt at least one structure selected from the group consisting of a thermocouple, a thermistor, and a thermal signal collection lens.
  • the energy output component includes an electrode, and the temperature measurement component is disposed on the electrode and directly monitors the electrode surface temperature to determine the target tissue surface temperature based on the electrode surface temperature.
  • the catheter body 2 also includes an axially extending temperature control fluid channel 22, and the temperature control fluid channel 22 and the imaging channel 21 are separately provided.
  • the distal portion 220 further includes a temperature-control fluid output hole 224 , and the temperature-control fluid output hole 224 is disposed on the electrode.
  • the distal end of the temperature control fluid channel 22 is connected to the temperature control fluid output hole 224 , and the proximal end extends to the proximal end of the catheter body 2 .
  • the proximal end of the temperature control fluid channel 22 is connected to the interface part 1 .
  • the temperature control fluid channel 22 is used to transport temperature control fluid.
  • the temperature-controlled fluid output hole 224 is used to release temperature-controlled fluid (such as hot fluid or cold fluid) with a certain temperature to the target tissue (such as ablated tissue), thereby reducing overheating damage or supercooling damage to the tissue. Therefore, during the energy treatment process, cold or hot fluid can be delivered to the target tissue by means of the temperature-controlled fluid channel 22 to maintain the temperature of the contact surface between the medical catheter 10 and the target tissue within the normal body temperature range, thereby protecting the non-treatment area. Increase the safety of the treatment process.
  • temperature-controlled fluid such as hot fluid or cold fluid
  • the temperature control fluid output hole 224 is a micropore, and the diameter of the micropore is 50 ⁇ m to 200 ⁇ m.
  • the setting of micropores can reduce the impact on the electrode when the temperature control fluid is output.
  • the temperature of the temperature control fluid can be adjusted according to actual needs, for example, it can be 15°C to 30°C.
  • the temperature and energy output of the temperature-controlled fluid can be adjusted simultaneously to achieve complete endothelial-protective ablation.
  • the catheter body 2 further includes an axially extending temperature control wire.
  • Channel 23 and electrode lead channel 24 are set independently.
  • the temperature control wire channel 23 and the electrode wire channel 24 are both arranged outside the imaging channel 21 .
  • the imaging channel 21 , the temperature control fluid channel 22 , the temperature control wire channel 23 , the electrode wire channel 24 and the bending control channel 25 are independently set up and do not interfere with or influence each other.
  • the bending control channel 25 , the temperature control wire channel 23 , the electrode wire channel 24 and the temperature control fluid channel 22 can be arranged on the same circumference, that is to say, the centers of these channels are on the same circumference and are all arranged around the imaging channel 21 .
  • the bending control channel 25, the temperature control wire channel 23, the electrode wire channel 24 and the temperature control fluid channel 22 can also be arranged on different circumferences, and this is not limited.
  • the temperature measuring component is connected to the distal end of the temperature control wire 6, and the proximal end of the temperature control wire 6 passes through the temperature control wire channel 23 and extends to the proximal end of the catheter body 2, for example, is connected to the interface part 1, specifically to the interface part.
  • the electrical signal interface 13 in 1 is connected.
  • the electrode is connected to the distal end of the electrode lead 7 , and the proximal end of the electrode lead 7 passes through the electrode lead channel 24 and extends to the proximal end of the catheter body 2 , for example, is connected to the interface portion 1 , specifically, can be connected to the electrical signal interface 13 .
  • the catheter body 2 further includes an axially extending administration channel (not shown).
  • the drug administration channel is arranged outside the imaging channel 21 .
  • the distal end of the drug administration channel is connected to the drug release structure, and the proximal end is connected to the interface part 1 .
  • the drug delivery channel is used to deliver drugs, and the drug release structure includes drug delivery holes and/or drug delivery microneedles, and is used to release drugs to target tissues.
  • the catheter body 2 can be directly a multi-lumen tube, and each chamber is directly used as a channel.
  • the catheter body 2 may be a single-lumen tube, and several partitions may be provided inside the catheter body 2 to isolate several channels from each other.
  • the catheter body 2 may be a single-lumen tube, and several small tubes may be wrapped inside the catheter body 2 as channels. Regardless of the structure, the catheter body 2 should have appropriate strength to support each channel. All channels in the catheter body 2 may be spaced apart from each other, may be located close to each other, or may be fixedly connected to each other when located close to each other.
  • the interface part 1 includes a fluid perfusion interface 11 , an imaging interface 12 , an electrical signal interface 13 (including a current interface) and a mechanical power transmission interface 14 .
  • the fluid perfusion interface 11 is used to connect with a fluid perfusion device to inject temperature-control fluid into the medical catheter 10.
  • the temperature-control fluid is generally physiological saline, such as cold saline.
  • the imaging interface 12 is used to connect to an imaging system.
  • the imaging system outputs imaging energy to the medical catheter 10 and receives acquisition signals fed back from the medical catheter 10 to acquire images and display them.
  • the electrical signal interface 13 is used to connect with an energy output system, such as a radio frequency system, which outputs treatment energy, such as radio frequency energy, to the medical catheter 10 .
  • the electrical signal interface 13 can also output electrical energy for temperature monitoring to the medical catheter 10 .
  • the electrical signal interface 13 can also be connected to an external control system, and the control system receives the temperature signal fed back from the medical catheter 10 .
  • the mechanical power transmission interface 14 is used to connect with a driving device, which drives the imaging diagnostic component 222 to rotate and move, so as to adjust the position and orientation of the imaging probe 2221 to align the target part to be monitored for imaging.
  • the energy output component includes an electrode for outputting radiofrequency energy to achieve radiofrequency ablation.
  • the number of electrodes is preferably multiple, and the multiple electrodes are arranged at intervals along the axial direction and/or circumferential direction of the catheter body 2 .
  • the electrodes may be ring electrodes or non-ring electrodes. When the electrode is in a ring shape, it can be suitable for concentric diffuse plaque ablation. When the electrode is non-circular, it is suitable for eccentric plaque ablation.
  • the medical catheter 10 provided in the embodiment of the present application preferably integrates both ring electrodes and non-ring electrodes, so that the medical catheter 10 can treat lesions in different locations to meet different clinical treatment needs.
  • the electrodes can be ring-shaped or strip-shaped, and can be prepared into a sheet-like structure or a mesh-like structure.
  • the electrode may be developable or non-developable, and there is no requirement for this.
  • a certain insulation distance needs to exist between the electrodes, and the insulation distance should not be too small or too large.
  • the insulation distance between electrodes is 1 mm to 5 mm in order to accurately control the ablation range and avoid discharge phenomena caused by too close electrode distance.
  • the size of the electrode can be set according to actual needs. In one embodiment, the width of the electrode along the axial direction of the medical catheter 10 is 2 mm to 10 mm, and the thickness of the electrode along the radial direction of the medical catheter may be 0.05 mm to 0.5 mm.
  • the electrode size should be set according to the size of the lesion. Generally, the larger the electrode size, the larger the ablation range. Since the size of plaque is usually around 1 mm, the axial width of the electrode can basically meet the treatment needs when set to 2 mm to 10 mm.
  • two electrodes are used as a schematic.
  • the two electrodes are the proximal electrode 225 and the distal electrode 226 respectively.
  • the proximal electrode 225 and/or the distal electrode 226 A temperature control fluid output hole 224 is provided on the top.
  • a temperature control fluid output hole 224 is provided on the proximal electrode 225, and the temperature control fluid is released through the temperature control fluid output hole 224 on the proximal electrode 225, so that the temperature control liquid fills the proximal electrode 225 and the distal electrode.
  • the entire ablation zone between 226 is provided on the proximal electrode 225 and the distal electrode 226 respectively.
  • the proximal electrode 225 and/or the distal electrode 226 A temperature control fluid output hole 224 is provided on the top.
  • a temperature control fluid output hole 224 is provided on the proximal electrode 225, and the temperature control fluid is released through the temperature control fluid output hole 224 on the proximal electrode 225, so that the temperature
  • the proximal electrode 225 and the distal electrode 226 are both ring-shaped electrodes, which are arranged at a certain distance in the axial direction, and the imaging probe 2221 is arranged between the proximal electrode 225 and the distal electrode 226 .
  • the area between the proximal electrode 225 and the distal electrode 226 is used as an ablation zone to perform radiofrequency ablation of the lesion, while the imaging probe 2221 monitors the therapeutic effect of the lesion in the ablation zone.
  • the distal end of the bending traction body 41 is connected to the distal tube body corresponding to the proximal end position of the proximal electrode 225 .
  • An electrode lead 7 is welded to each electrode.
  • the electrode lead 7 is specifically welded to the inner surface of the electrode.
  • the far end of the electrode lead 7 can pass through the tube wall and be connected to the inner surface of the electrode.
  • the material of the electrode lead 7 should be set according to the requirements, for example, the material of the electrode lead 7 should be selected according to the impedance value of different lengths.
  • the electrode lead 7 and the temperature control lead 6 may share the same electrical signal interface 13, or they may use two independent electrical signal interfaces 13.
  • the outer diameter of the medical catheter 10 should be set according to the diameter of the inserted lumen.
  • the outer diameter of the medical catheter 10 can be 1.0 mm to 10.0 mm to adapt to systemic diseases. Further, the outer diameter of the medical catheter 10 does not exceed 2 mm to solve the problem of ablation plaque treatment in a smaller size.
  • the outer diameter of the medical catheter 10 mainly refers to the outer diameters of the catheter body 2, the connecting portion 5 and the head end 3.
  • the outer diameters of the catheter body 2 and the connecting portion 5 are usually the same, and the proximal outer diameter of the head end 3
  • the outer diameter of the catheter body 2 is also the same.
  • the medical catheter 10 involved in this embodiment is applied to coronary blood vessels.
  • the outer diameter of the catheter body 2 is 1.0 mm to 3.0 mm, preferably 1.8 mm to 2.0 mm. If the outer diameter of the catheter body 2 exceeds 3.0 mm, the size will be too large and it will be difficult to intervene in coronary blood vessels. If the outer diameter of the catheter body 2 is less than 1.0 mm, it will be difficult to integrate various channels inside it, increasing the process difficulty.
  • the wall thickness of the catheter body 2 can be 0.1 mm to 0.5 mm, which not only ensures the overall strength of the medical catheter 10 but also ensures good flexibility of the medical catheter 10 .
  • the diameter of the imaging channel 21 does not exceed 1.0mm
  • the diameter of the temperature control fluid channel 22 does not exceed 0.5mm
  • the diameter of the electrode wire channel 24 is 0.1mm ⁇ 0.5mm
  • the diameter of the temperature control wire channel 23 is 0.1mm ⁇ 0.5 mm; by controlling the diameter of each channel, while being able to fully accommodate each part of the structure, it also reduces the mutual influence between the various parts of the structure, ensuring that each function can be operated and realized normally.
  • the medical catheter 10 is used as an ablation catheter, and uses OCT imaging and radiofrequency ablation, which is applied to the conformal treatment of atherosclerotic plaques.
  • the outer diameter of the catheter body 2 is 2.0 mm.
  • the catheter body 2 is provided with an imaging channel 21, a temperature control fluid channel 22, two temperature control wire channels 23, two electrode wire channels 24 and four There is a controlled bend channel 25.
  • the temperature measurement component is a thermocouple.
  • the electrodes are two ring-shaped electrodes. The two ring-shaped electrodes are arranged at intervals along the axial direction of the catheter body 2.
  • the two ring-shaped electrodes are made of platinum-iridium alloy and have uniform thickness.
  • the electrode wire 7 and the temperature control wire 6 are welded.
  • the temperature control wire 6 is made of copper-nickel alloy, and the electrode wire 7 is made of platinum-iridium alloy.
  • the two temperature control wires 6 and the two electrode wires 7 are distributed on the imaging channel 21 All around, symmetrically distributed relative to the imaging channel 21, each ring-shaped electrode is provided with a temperature-control fluid output hole 224.
  • the number of the temperature-control fluid output hole 224 is 12, the aperture is 90 ⁇ m, and is evenly distributed along the circumferential direction of the electrode.
  • Curved traction body 41 The number is four, and the four bending traction bodies 41 are arranged in one-to-one correspondence with the four bending control channels 25.
  • the proximal ends of the four bending traction bodies 41 are respectively connected to the four bending control parts 42, and the distal ends are connected to the distal ends.
  • a temperature control fluid channel 22, two temperature control wire channels 23, two electrode wire channels 24 and four bend control channels 25 are arranged on the imaging channel 21 around, the imaging channel 21 is set at the center of the medical catheter 10, the temperature control fluid channel 22, the two temperature control wire channels 23, the two electrode wire channels 24 and the four bend control channels 25 are arranged on the same circumference to reduce
  • the overall outer diameter of the small catheter is 0.5 mm in diameter
  • the diameter of the imaging channel 21 is 0.3 mm
  • the diameter of the temperature control fluid channel 22 is 0.3 mm
  • the two temperature control wire channels 23 are symmetrically arranged relative to the imaging channel 21, and the two electrode wire channels 24 are also arranged relative to the imaging channel 21.
  • the imaging channels 21 are arranged symmetrically. With this arrangement, the problem of integration and compatibility of light, electricity and heat on the medical catheter 10 can be better solved, and the mutual influence and mutual interference between these structures can be reduced.
  • the guide wire delivers the ablation catheter into the blood vessel through the guide wire lumen 31 of the head end 3 .
  • the head end 3 has a quick-exchange design. By placing the guidewire lumen 31 in front, interventional instruments can be quickly replaced and the overall design size of the catheter can be reduced.
  • the diameter of the guidewire cavity 31 is 0.5mm; the axial length of the head end 3 is 30mm.
  • the head end 3 is connected to the distal part 220 through a connecting part 5 made of polyurethane, such as an adhesive connection.
  • the outer diameter of the connecting part 5 is 2.0 mm, and the axial length is 20 mm.
  • the imaging interface 12 and the mechanical power transmission interface 14 are integrated into one, and this integrated interface is connected to the imaging system.
  • the imaging diagnosis component 222 emits laser light and collects blood vessel reflections through a combination of imaging optical fiber and gradient refractive index lens. optical signal to monitor the treatment process of radiofrequency ablation; the imaging probe 2221 uses a gradient refractive index (GRIN) lens, which is set between two ring electrodes and can receive and emit light beams through the imaging window 223; the imaging optical fiber is The imaging channel 21 moves and rotates axially along with the driving device, and at the same time, optical signals are emitted and collected through the gradient refractive index lens.
  • GRIN gradient refractive index
  • cold saline enters the temperature-controlled fluid channel 22 from the fluid perfusion equipment through the fluid perfusion interface 11, flows to the lesion through the temperature-controlled fluid output hole 224 on the electrode, and is cooled during the radiofrequency ablation process to protect endothelial cells. ;
  • the flow rate of cold salt water can be adjusted to meet different cooling needs.
  • the medical catheter 10 of this embodiment can be used in the following ways, specifically including:
  • the energy output system is turned on to release the therapeutic energy or therapeutic agent to the lesion.
  • the imaging probe 2221 continuously monitors the therapeutic effect of the designated part through the imaging window 223. or the extent of therapeutic agent release;
  • each interface in the interface section 1 is connected to the corresponding imaging system, radio frequency system and fluid perfusion equipment. Then, the medical catheter 10 is transported into the blood vessel via the guide wire 30 along the guide wire lumen 31 of the head end 3, and the imaging fiber and the imaging probe 2221 are controlled to move and rotate in the imaging channel 21 through mechanical force, and the imaging probe 2221 emits laser.
  • the imaging system uses OCT analysis to image the blood vessel and analyze the shape and composition of the plaque 20; then, according to the imaging results, align the electrode to the site to be ablated; pull the bending control member 42 to adjust the distal part 220, so that the distal part 220 is tightly attached to the fibrous plaque 20, see Figure 7; then, turn on the radio frequency system, apply radio frequency current through the electrical signal interface 13, and generate impedance within the plaque 20 heat to ablate blood vessel plaques.
  • the imaging fiber continues to rotate to collect real-time signal imaging and monitor the degree of ablation.
  • the thermocouple on the electrode surface monitors the ablation temperature in real time.
  • cold saline is continuously perfused from the temperature-controlled fluid output hole 224. Rinse the electrode and ablate the tissue surface, regulate temperature, and reduce endothelial cell damage. After the ablation of one lesion is completed, the distal part 220 is released (see FIG. 6 ), and the medical catheter 10 is moved to the next lesion to perform the same ablation process. After the treatment, OCT imaging of the entire blood vessel was performed to evaluate the treatment effect. Finally, the catheter is withdrawn and the procedure is completed.
  • the ablation catheter in the embodiment of the present invention is not limited to a radiofrequency ablation catheter, and may also be a cryoablation catheter. If it is a cryoablation catheter, a freezing fluid channel needs to be provided inside the catheter body 2, and an outlet is provided at the distal end of the freezing fluid channel, and is used to spray freezing liquid to the inner surface of the balloon. At this time, a balloon can be coated on the distal part 220. . It is also important to understand that in the current technology, there is no radiofrequency ablation of atherosclerotic plaques guided by intravascular imaging and temperature control.
  • the outer diameter of the medical catheter provided by the present invention can be no more than 2mm.
  • the problem of thermal ablation plaque treatment in smaller sizes can be solved, and through the effective combination of imaging, temperature monitoring and radiofrequency ablation, radiofrequency ablation can be achieved.
  • the ablation is more precise and the ablation effect is better.
  • the bending control function is added to achieve the purpose of conforming the treatment to the shape of the lesion space, allowing more precise targeted treatment and improving the treatment effect.
  • the medical catheter provided by the present invention can diagnose and treat vascular diseases, heart diseases, etc. in one or more ways, such as using OCT imaging to formulate a treatment plan before treatment, and during the treatment process, OCT imaging and temperature Monitor real-time feedback on the treatment effect, and then evaluate the overall treatment effect after the treatment is completed to effectively improve the treatment effect.
  • OCT imaging to formulate a treatment plan before treatment
  • OCT imaging and temperature Monitor real-time feedback on the treatment effect
  • the catheters are arranged in segments and the nesting of functional parts is used to solve the technical problems of component distribution and function realization in a small physical space, and realize the multi-functional and integrated diagnosis and treatment of one tube.
  • the medical catheter can effectively improve the expected clinical effect after application.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Optics & Photonics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Plasma & Fusion (AREA)
  • Mechanical Engineering (AREA)
  • Electromagnetism (AREA)
  • Cardiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明涉及一种医疗导管，包括导管主体和控弯部件，所述导管主体包括近端部分以及位于导管主体远端的远端部分，所述远端部分用于成像监控，还用于释放治疗能量和/或治疗剂，所述远端部分与控弯部件连接，并用于在控弯部件的控制下相对于近端部分弯曲。使用本发明的医疗导管后，在治疗过程中可以实时成像监控治疗效果，还可以随时调整远端部分的弯曲角度，使远端部分与病灶贴靠紧密，从而实现病灶的精准靶向治疗，提升治疗效果，提高手术成功率。

Description

医疗导管 技术领域
本发明涉及医疗器械技术领域，特别涉及一种诊疗一体且可控弯的医疗导管。
背景技术
动脉粥样硬化是影响动脉血管的综合征。动脉粥样硬化导致在动脉的壁中的慢性炎性响应，其大部分是由于脂质、巨噬细胞、泡沫细胞的累积以及在动脉壁中形成斑块所导致。动脉粥样硬化通常称为动脉硬化，疾病的病理生理学显现几种不同类型的病变，范围从纤维化到充满脂质到钙化。目前，临床上针对动脉粥样硬化主要的成熟治疗手段包括药物、介入和搭桥手术，但仍然存在远期再狭窄及血栓形成等问题。
热物理治疗，由于其相对较低的成本、很少的副作用以及较短的治疗时间，已经广泛用于临床中。实现热物理治疗的手段有热消融术。热消融术的能量产生方式主要有冷冻球囊、聚焦超声、激光和射频等。临床研究表明，射频消融有确定的安全频率、热能量输出可控以及更易于功能集成等优势。在热物理治疗时，为了保证消融效果，需要造成一定的组织损伤范围，但是目前还没有相关的技术手段来对纤维斑块消融范围进行精准的监控和控制。
目前的监控手段主要是血管腔内成像。血管腔内成像技术主要包括OCT(光学相干断层成像)、IVUS(血管内超声成像)、血管镜及血管内MRI等。相较于其他成像技术而言，OCT技术在成像分辨率方面具有明显优势(分辨率优于10μm)，更能够获得生物组织的高清图像，非常有利于血管内斑块的精准成像与识别。但在治疗过程中，诊断和治疗过程通常是分开的，因此，需要频繁地更换成像导管和消融导管，不仅会增加整体治疗成本，而且不能提供及时的治疗，在某些情况下仍具有较高的复发率。此外，在治疗过程中，消融导管也会经常因为与组织(病灶)之间的贴靠不良，导致治疗效果不佳甚至失败的问题。
发明内容
本发明的目的在于提供一种医疗导管，以解决现有技术在治疗过程中因为导管与目标组织间的贴靠不良导致治疗效果不佳甚至手术失败的问题，并同时解决诊断和治疗过程分开所产生的问题。
为实现上述目的，本发明提供了一种医疗导管，其包括导管主体和控弯部件，所述导管主体包括近端部分以及位于所述导管主体远端的远端部分，所述远端部分用于成像监控，还用于释放治疗能量和/或治疗剂，所述远端部分与所述控弯部件连接，并用于在所述控弯部件的控制下相对于所述近端部分弯曲。
在一实施方式中，所述远端部分还包括远端管体，所述近端部分包括近端管体，所述远端管体的硬度小于所述近端管体的硬度。
在一实施方式中，所述控弯部件包括调弯牵引体和控弯件，所述控弯件设置在所述导管主体的近端，所述调弯牵引体的远端与所述远端部分连接，所述调弯牵引体的近端穿过所述导管主体后与所述控弯件连接，所述调弯牵引体用于在所述控弯件的驱动下控制所述远端部分弯曲。
在一实施方式中，所述调弯牵引体的数量为多个，多个所述调弯牵引体围绕所述导管主体的中心轴线沿周向均匀布设。
在一实施方式中，每个所述调弯牵引体与至少一个所述控弯件连接，不同的所述调弯牵引体连接不同的所述控弯件。
在一实施方式中，所述医疗导管还包括接口部，所述近端部分的近端连接所述接口部， 所述控弯件可活动地设置在所述接口部上。
在一实施方式中，所述导管主体还包括轴向延伸设置的控弯通道，所述调弯牵引体在所述控弯通道中穿行。
在一实施方式中，所述控弯部件包括磁响应形变部件和/或光致形变部件，所述磁响应形变部件由磁响应材料制成，能够在磁场作用下产生形变，所述光致形变部件由光响应材料制成，能够在吸收光能后产生光致形变。
在一实施方式中，所述医疗导管还包括接口部，所述近端部分的近端连接所述接口部，所述接口部用于与对应的外部设备连接，以输入和输出信息。
在一实施方式中，所述远端部分包括成像诊断部件和治疗部件，所述成像诊断部件用于成像监控，所述治疗部件用于释放治疗能量和/或治疗剂；
所述成像诊断部件包括成像探头，所述导管主体还包括轴向延伸设置的成像通道，所述成像通道中设置有与所述成像探头连接的成像传输结构，所述成像通道的中心轴线与所述导管主体的中心轴线重合。
在一实施方式中，所述远端部分还包括成像窗口，所述成像探头设置在所述成像窗口处。
在一实施方式中，所述成像探头为光学探头，所述成像传输结构包括成像光纤、保护管和扭力弹簧，所述保护管套设于所述成像光纤上，所述扭力弹簧设置在所述保护管和所述成像光纤之间，所述成像光纤的一端连接所述成像探头，另一端沿所述成像通道延伸至所述导管主体的近端。
在一实施方式中，所述医疗导管还包括接口部，所述近端部分的近端连接所述接口部，所述接口部包括成像接口以及机械动力传导接口，所述成像光纤的所述另一端连接所述机械动力传导接口和所述成像接口，所述成像诊断部件用于在驱动设备驱动下沿所述导管主体的周向旋转和/或沿所述导管主体的轴向移动。
在一实施方式中，所述治疗部件包括能量输出部件，所述能量输出部件能够输出射频、超声波、激光及冷冻流体中的至少一种治疗能量，和/或，所述治疗部件包括治疗剂输出部件，所述治疗剂输出部件包括药物涂层和药物释放结构中的至少一种，所述药物释放结构包括给药孔和/或给药微针。
在一实施方式中，所述治疗部件包括所述能量输出部件，所述能量输出部件包括电极，所述远端部分还包括设置在所述电极上的测温部件，所述测温部件用于获取电极表面温度。
在一实施方式中，所述导管主体还包括轴向延伸设置的控温流体通道，所述远端部分还包括控温流体输出孔，所述控温流体输出孔设置在所述电极上，所述控温流体通道的远端与所述控温流体输出孔连接，所述控温流体通道用于输送控温流体。
在一实施方式中，所述导管主体还包括轴向延伸设置的温控导线通道和电极导线通道，所述测温部件与控温导线的远端连接，所述控温导线的近端穿过所述温控导线通道并延伸至所述导管主体的近端；所述电极与电极导线的远端连接，所述电极导线的近端穿过所述电极导线通道并延伸至所述导管主体的近端。
在一实施方式中，所述能量输出部件包括电极，所述电极用于输出射频，所述电极的数量为多个并沿所述导管主体的轴向和/或周向间隔排布。
在一实施方式中，所述远端部分的远端通过弹性连接部连接头端，所述头端设置有导丝腔。
与现有技术相比，本发明技术方案提供的医疗导管至少具有以下有益效果：
本发明的医疗导管具有远端部分，该远端部分既可用于成像监控，还可用于释放治疗能量和/或治疗剂，使医疗导管实现了诊断和治疗的一体化，而且远端部分能够在控弯部件的控制下弯曲。如此设置后，本发明在对病灶部位进行介入治疗时，无需更换成像导管和 治疗导管，省去了频繁更换导管的操作，不仅简化了手术过程，也避免了更换不同导管后重新定位导管的难度，保证了导管在治疗过程中的定位精度。此外在治疗过程中，远端部分可以实时监控治疗效果，有利于精准地调控治疗能量和/或治疗剂的输出，并结合控弯部件的控弯功能，可以随时调整远端部分的弯曲角度，确保远端部分与病灶始终可以良好的贴靠，最终达到精准靶向治疗病灶的目的，提升治疗效果，并提高手术成功率，缩短手术时间。不仅于此，医疗导管的控弯功能使得导管可适应于不同形状的病灶治疗，使用更为灵活和方便，应用范围更广。因此，本发明的医疗导管能够实现病灶部位的精准化治疗，并且精简了治疗步骤，方便了医护人员操作。再者，本发明的医疗导管在治疗过程中可以重复使用直至治疗完全，节省物料消耗，有利于降低当前介入术后并发症发生率，提高临床治疗效果，减少再住院率，减少因疾病带来的家庭负担和社会经济损失，具有较好的经济效益和生态效益。
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。附图中：
图1是本发明一实施方式中的医疗导管的整体结构示意图；
图2是本发明一实施方式中的医疗导管的详细结构示意图；
图3是本发明实施例一中的医疗导管中设置控弯部件时的详细结构示意图；
图4是图3中医疗导管在a位置的局部放大图；
图5a是图4中结构沿A-A连线的剖面图；
图5b是图4中结构沿B-B连线的剖面图；
图5c是图4中结构沿C-C连线的剖面图；
图6是本发明一实施方式中的医疗导管经头端上的导丝腔沿导引导丝输送至血管的使用场景图；
图7是本发明一实施方式中的医疗导管的远端部分相对于近端部分弯曲，使远端部分贴靠病灶(纤维斑块)的使用场景图。
其中，附图标记说明如下：
10-医疗导管；1-接口部；11-流体灌注接口；12-成像接口；13-电信号接口；14-机械动
力传导接口；2-导管主体；21-成像通道；22-控温流体通道；23-温控导线通道；24-电极导线通道；25-控弯通道；210-近端部分；220-远端部分；221-治疗部件；222-成像诊断部件；2221-成像探头；2222-成像传输结构；223-成像窗口；224-控温流体输出孔；225-近端电极；226-远端电极；3-头端；31-导丝腔；4-控弯部件；41-调弯牵引体；42-控弯件；5-连接部；6-控温导线；7-电极导线；20-纤维斑块；30-导引导丝。
具体实施方式
下面将结合示意图对本发明进行更详细的描述，其中表示了本发明的优选实施例，应该理解本领域技术人员可以修改在此描述的本发明，而仍然实现本发明的有利效果。因此，下列描述应当被理解为对于本领域技术人员的广泛知道，而并不作为对本发明的限制。
为了清楚，不描述实际实施例的全部特征。在下列描述中，不详细描述公知的功能和结构，因为它们会使本发明由于不必要的细节而混乱。应当认为在任何实际实施例的开发中，必须做出大量实施细节以实现开发者的特定目标，例如按照有关模组或有关商业的限制，由一个实施例改变为另一个实施例。另外，应当认为这种开发工作可能是复杂和耗费时间的，但是对于本领域技术人员来说仅仅是常规工作。在下列段落中参照附图以举例方式更具体地描述本发明。根据下面说明，本发明的优点和特征将更清楚。需说明的是，附 图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
此外，在本申请使用的术语是仅仅出于描述特定实施方式的目的，而非旨在限制本申请。在本申请中所使用的单数形式的“一种”、“所述”和“该”也旨在包括多数形式，除非上下文清楚地表示其他含义。应当理解，本申请说明书中使用的“一个”或者“一”等类似词语也不表示数量限制，而是表示存在至少一个；“多个”表示两个及两个以上的数量。除非另行指出，“远端”、“近端”、“上方”和/或“下方”等类似词语只是为了便于说明，而并非限于一个位置或者一种空间定向。“包括”或者“包含”等类似词语意指出现在“包括”或者“包含”前面的元件或者物件涵盖出现在“包括”或者“包含”后面列举的元件或者物件及其等同，并不排除其他元件或者物件。还应当理解，本申请说明书中使用的“若干”表示数量不确定的含义。
在以下说明中，为了便于描述，使用了“远端”和“近端”、“轴向”以及“周向”；“远端”是远离医疗导管的操作者的一侧；“近端”是靠近医疗导管的操作者的一侧；“轴向”参照的是沿着医疗导管的中心轴线方向；“周向”参照的是围绕医疗导管的中心轴线方向；“中心轴线”参照的是医疗导管的长度方向；“径向”参照的是医疗导管的直径方向。
下面结合附图和优选实施例，对本申请进行详细说明，且在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。
如图1和图2所示，本发明一实施方式提供了一种医疗导管10，该医疗导管10集诊断和治疗为一体，且医疗导管10的远端还能弯曲。本实施例提供的医疗导管10不限于在血管内介入治疗，还可以在食道、前列腺管道、肠道等非血管腔道中介入治疗。优选地，本实施例所涉及的医疗导管10用于介入冠脉血管进行治疗，如治疗动脉粥样硬化等疾病，治疗效果好。
具体地，医疗导管10包括导管主体2。导管主体2包括近端部分210以及位于导管主体2远端的远端部分220。远端部分220可实现目标管腔内的成像监控，还可在目标管腔内向目标位置释放治疗能量和/或治疗剂。所述目标管腔指的是血管或非血管腔道。所述治疗能量的种类不限定，如可以是射频、超声波、激光及冷冻流体中的至少一种。所述治疗剂主要为药物。如图3所示，本申请实施例的医疗导管10还包括控弯部件4。控弯部件4至少部分设置在导管主体2中。远端部分220与控弯部件4连接，并用于在控弯部件4的控制下相对于近端部分210弯曲。
如此设置后，使本发明的医疗导管10兼具成像导管和治疗导管的功能，实现了诊断和治疗的一体化，在对病灶部位进行介入治疗时，无需更换成像导管和治疗导管，从而省去了交换导管的操作过程，不仅简化了手术过程，也避免了交换不同导管后重新寻找治疗位点的困难。除此之外，治疗过程中，远端部分220还可以实时监控治疗效果，以便精准靶向治疗病灶，提升治疗的精准性和有效性。与此同时，在治疗过程中，控弯部件4可以随时调整远端部分220的弯曲角度，使远端部分220始终与病灶贴靠紧密，从而精准地对准病灶，最终实现病灶的精准靶向治疗，将显著提升治疗效果，提高手术成功率。
本申请对远端部分220的弯曲角度没有限制，如可以为小于或等于90°或者大于90°且小于180°。远端部分220的弯曲角度可以根据实际需求设定。
远端部分220可以采用一种或多种成像方式实现对目标管腔的成像监控，如光学成像及超声成像中的至少一种成像方式，优选采用OCT光学相干断层成像。OCT的成像分辨率最高，有利于血管内斑块的成像和分辨。
远端部分220能够释放一种或多种治疗能量，如能够释放射频、超声波、激光及冷冻流体中的至少一种治疗能量。
远端部分220可以采用一种或多种方式向目标位置释放治疗剂。所述治疗剂优选为药 物。本发明对药物的种类不作限定，所述药物可根据需求选择，如抗增殖的、抗增生的、抗再狭窄的、抗炎的、抗菌的、抗肿瘤的、抗有丝分裂的、抗转移的、抗血栓的、抗骨质疏松症的、抗血管生成的、抑制细胞的、抑制微管的药物。
在一实施方式中，远端部分220包括治疗部件221和成像诊断部件222。治疗部件221用于向目标位置(包括病灶，如纤维斑块)释放治疗能量和治疗剂中的至少一种。治疗部件221可以输出射频、超声波、激光及冷冻流体中的至少一种治疗能量，和/或，治疗部件221采用一种或多种结构向目标位置释放治疗剂。成像诊断部件222用于对病变区域进行成像，便于在治疗之前分辨病灶位置和病灶组分，也便于在治疗过程中监控治疗效果或者监控治疗剂释放程度，还便于在病变区域治疗完毕后，进行成像扫描评估治疗效果。本申请对成像诊断部件222的成像方式不限定。成像诊断部件222可以是光学成像或超声成像，优选为OCT成像。
本实施例中，远端部分220还包括远端管体，近端部分210包括近端管体。治疗部件221设置于远端管体上。成像诊断部件222设置在远端管体中。如治疗部件221包括电极时，电极设置在远端管体的外周面上。如治疗部件221包括给药孔时，给药孔设置在远端管体的外周面上并穿透管壁。又如治疗部件221包括药物涂层时，药物涂层覆盖在远端管体的外周面上。可以理解，远端管体本身可以形成治疗部件221，如给药孔、给药微针等，使治疗部件221和远端管体集成为一体，也可以是在远端管体上额外地设置治疗部件221，如电极、药物涂层等。
需理解，近端管体与远端管体可以独立加工成型后组装，近端管体与远端管体也可以一体加工成型而无需组装。为便于控弯，优选地，所述远端管体的硬度小于近端管体的硬度，使远端管体整体比较柔软，便于控弯，而近端管体整体比较硬，便于推送和操控。所述远端管体的近端与近端管体的远端可以分体式连接或一体式连接。在一具体实施方式中，所述远端管体和近端管体均由聚酰胺类材料如尼龙、PEBAX等制成，并将近端管体设置为多层管结构，如在内层管和外层管之间增加至少一个金属层(如编织管或绕簧管)，从而提升近端部分210的强度或刚度。然而，在本申请其他实施方式中，近端管体和远端管体也可以采用不同硬度的材料制成。
本申请对控弯部件4的结构没有特殊限制。如图3所示，在一实施方式中，控弯部件4包括调弯牵引体41和控弯件42。控弯件42设置在导管主体2的近端。调弯牵引体41的远端与远端部分220连接，调弯牵引体41的近端穿过导管主体2后与控弯件42连接。调弯牵引体41用于在控弯件42的驱动下控制远端部分220弯曲。
调弯牵引体41的数量可以是一个或多个，通常为多个。当调弯牵引体41的数量为多个时，可以是2个或超过2个，调弯牵引体41的数量主要为偶数个，如2个、4个、6个或更多个。优选地，多个调弯牵引体41围绕导管主体2的中心轴线沿周向均匀布设，便于实现360°全方位弯曲，使调弯更灵活和方便，应用范围更广。通常，调弯牵引体41的数量设置为四个或六个，已然能满足实际诊断和治疗需求。调弯牵引体41优选由寿命长、回复性好、重复弯曲精准度高、屈服强度高的材料制备，如镍钛合金、不锈钢等金属材料。调弯牵引体41可以为诸如：拉绳、丝线或杆状结构等任意合适的结构。调弯牵引体41优选为丝材，如圆形丝材，直径可以是0.01mm～0.2mm，该直径在确保丝材不会被轻易拉断的情况下，还不会增加医用导管整体的尺寸。
不同的调弯牵引体41由不同的控弯件42控制，但是控弯件42的数量与调弯牵引体41的数量可以一致或不一致，如可以由一个控弯件42同时控制一个调弯牵引体41，或者由多个控弯件42同时控制一个调弯牵引体41。在本申请实施方式中，多个控弯件42与多个调弯牵引体41一一对应地连接，使每一个调弯牵引体41由对应的一个控弯件42进行控制，这样设置，可使控弯操作更为精准和可靠，控弯难度也降低，而且结构简单易于实 现。控弯件42可以为控弯旋钮或控弯移动件，可以通过转动或移动来释放或收紧调弯牵引体41。
如图1和图2所示，作为一实施方式，医疗导管10还包括接口部1，近端部分210的近端连接接口部1，控弯件42可活动地设置在接口部1上。此处，“可活动地设置”是指，控弯件42设置在接口部1上，但是可以相对于接口部1转动或移动。在本申请其他实施例中，可取消接口部1。
在其他实施方式中，控弯部件4可以是设置在远端管体中的磁响应形变部件，磁响应形变部件由磁响应材料制成，能够在外部磁场作用下产生形变而完成弯曲运动，以此促使远端部分220相对于近端部分210弯曲。而且磁场消失后，磁响应形变部件可以恢复原状，也就使得远端部分220恢复原状。更详细地，磁响应形变部件为由复合了磁响应微粒(如四氧化三铁或钕铁硼等)的聚合物材料制成，可制成棒状并置于远端管体的中间位置附近，轴向位置不局限，在外部磁场驱动下，磁响应形变部件产生不同方向、不同程度的形变，从而带动远端部分220弯曲一定角度。
在其他实施方式中，控弯部件4可以是设置在远端管体中的光致形变部件，光致形变部件由光响应材料制成，能够在吸收光能后产生光致形变而完成弯曲运动，以此促使远端部分220相对于近端部分210弯曲。例如光致形变部件为条形光敏元件，在远端管体中粘贴条形光敏元件，通过条形光敏元件的光致形变促使远端部分220相对于近端部分210弯曲。而且光线消失后，光致形变部件可以恢复原状，也就使得远端部分220恢复原状。更详细地，光致形变部件采用光致形变材料(如偶氮苯类聚合物、PLTZ陶瓷)，并制成条形结构，贴于远端管体中，并在医疗导管10内的光照部件照射下，在特定照射位置产生形变，从而带动远端部分220弯曲一定角度。
优选，采用占用空间小的控弯部件4来实现远端部分220的弯曲。需要说明的是，控弯部件4可以采用以上一种或多种结构实现控弯调控。此外，调弯牵引体41的控弯方式相比于其他控弯方式而言，结构更简单，在工艺上相对容易实现，而且所占空间比较小，有利于控制医疗导管10的整体尺寸。
在本申请实施方式中，远端部分220输送到指定病灶位置时，通过牵引控弯件42，即可拉动调弯牵引体41带动远端部分220弯曲一定角度，以适应不同病灶的形貌，提高贴合程度和治疗效果。可选地，控弯件42调节远端部分220，以形成0°～90°的弯曲角度，实现消融病灶适形贴合的目的。这里的“适形”是指，根据病灶部位的形状调节弯曲角度，使远端部分220与病灶良好的贴靠。
当控弯部件4采用调弯牵引体41进行控弯时，在一些实施例中，导管主体2内设置有独立的控弯通道25(参见图5a)，以供调弯牵引体41穿行。在其他实施例中，可以取消控弯通道25，而与其他通道共用来布设调弯牵引体41，以此减小通道的数量，控制医疗导管10的整体尺寸。
以四个调弯牵引体41为例，如图5a所示，在一具体示例中，四个调弯牵引体41对应设置四个控弯通道25，四个控弯通道25围绕导管主体2的中心轴线错开90°设置，每个控弯通道25仅供一个调弯牵引体41通过。
调弯牵引体41的远端优选设置在成像诊断部件222的近端侧，具体设置在下述的成像探头2221的近端侧，以避开成像探头2221，减小对成像影响，确保成像质量。但是实际上，调弯牵引体41与远端部分220连接的位置根据控弯角度设定即可。
如图1和图2所示，在一实施方式中，近端部分210的近端连接接口部1，接口部1用于与外部设备连接，以输入和输出信息。所述外部设备可以是成像系统、能量输出系统、流体灌注设备、驱动设备等。接口部1所输入和输出的信息至少包括能量，能量至少包括成像用的能量，如光能或电能。接口部1包括若干接口，接口的数量和种类根据远端部分 220本身的功能设定。
如图1和图2所示，在一实施方式中，远端部分220的远端通过连接部5连接有头端3。连接部5起到实体封端以及连接远端部分220和头端3的作用。连接部5为实心体，可以进一步密封远端管体的远端端部，并实现远端部分220与头端3之间的连接。优选地，连接部5为弹性体，以减小头端3的损伤风险。制作连接部5的材料可以是聚氨酯或者硅酮。连接部5的直径与导管主体2的直径一致。连接部5的长度不宜过长或过短；若过长，则会降低医疗导管10的推送性能；若过短，对头端3的保护效果有限。优选地，连接部5的轴向长度为1mm～10mm。
头端3为锥形头，通常较软且为无损伤结构，可以减小对血管或组织的损伤。头端3优选设置有导丝腔31，可供导引导丝穿过，以实现快速交换。导丝腔31的前置，使得在不影响医疗导管10整体尺寸的情况下，更加方便进行医疗导管10的更换与操作。导丝腔31的直径应结合导引导丝的直径设定，如导丝腔31的直径为0.1mm～2mm。此外，头端3的尺寸不宜过大，否则不容易通过狭窄病变，因此，头端3的尺寸较小。头端3不易过长，若过长则头端3比较尖锐，会损伤血管或组织，头端3若过短，则会影响穿越性能。可选地，头端3的轴向长度为5.0mm～50mm，优选为20mm。
在一实施方式中，如图2所示，成像诊断部件222包括成像探头2221，成像探头2221通过成像传输结构2222传输成像用的能量和采集的信号。可选地，成像传输结构2222的一端连接成像探头2221，另一端穿过远端部分220和近端部分210后与接口部1连接。成像探头2221包括但不限于微透镜(光聚集组件)、超声探针和光反射镜等结构。成像探头2221可以采用微透镜、超声探针和光反射镜中的至少一种。也即，成像诊断部件222的成像方式可以是一种或两种以上的组合。
在一实施方式中，成像诊断部件222采用OCT成像，其采用超低传播损耗、极低直径(如200μm)的成像光纤作为导光介质，并采用成像光纤远端的微透镜作为成像探头2221。微透镜可以为光聚焦组件。光聚焦组件可以是球透镜或梯度折射率透镜。由于光纤本身是玻璃丝，很脆，使用时如果不加以保护，极易折断，因此，整根成像光纤封装在一个保护管中形成传导光缆，以避免光学元件和远端光聚焦组件运动过程中的机械损伤，而且抗拉和抗弯折性能更好。所述保护管可选为透明管。
如图4所示，并结合图5a和图5b，导管主体2还包括容纳成像传输结构2222用的成像通道21，成像通道21沿导管主体2的轴向延伸布设。成像通道21的中心轴线优选与导管主体2的中心轴线重合，即，成像通道21处于医疗导管10的中心位置。这样设置，方便在成像通道21的外围布置其他功能的通道，使导管主体2的内部空间被有效利用，在确保导管主体2具有足够强度的同时，避免加大医疗导管的外径，以便于介入细小的血管中治疗。
如图2和图4所示，远端部分220还包括成像窗口223。成像探头2221设置在成像窗口223处。成像窗口223优选为透明。成像窗口223便于成像探头2221发射和接收光束。成像窗口223的轴向长度和远端管体的轴向长度可以相等，即可以将整根远端管体设置为透明部分。或者，远端管体的轴向长度大于成像窗口223的轴向长度，即远端管体部分设置为透明部分。可选地，成像窗口223的轴向长度为2mm～100mm。成像窗口223的轴向长度可以定义为，从连接部5的近端朝导管主体2方向延伸的轴向长度。制备远端管体中的透明部分的材料可以为透明尼龙等。近端部分210通常由不透明材料制成，如聚酰胺等材料制备。需说明的是，若不采用光学成像，则可取消成像窗口223。
在一实施方式中，成像诊断部件222采用光学成像，此时，成像传输结构2222包括成像光纤，成像探头2221为光学探头。优选地，成像传输结构2222还包括保护管和扭力弹簧。所述保护管套设于成像光纤上。所述扭力弹簧设置在保护管和成像光纤之间。所述成 像光纤的一端连接成像探头2221，另一端连接接口部1。扭力弹簧的设置，可以更好地传导扭力，以便顺利地驱动成像光纤和成像光纤远端的成像探头2221运动。
在一实施方式中，如图2所示，接口部1包括成像接口12以及机械动力传导接口14，所述成像光纤的另一端连接机械动力传导接口14和成像接口12，使成像诊断部件222在外部驱动设备驱动下沿导管主体2的周向旋转和/或沿导管主体2的轴向移动。机械动力传导接口14可与成像接口12集成为一体或者两者分开独立设置。所述驱动设备通过机械动力传导接口14带动成像传输结构2222和成像探头2221移动和旋转。所述驱动设备可选用马达。
在一实施例中，治疗部件221包括能量输出部件，用于输出治疗能量。所述能量输出部件能够输出射频、超声波、激光及冷冻流体中的至少一种治疗能量。所述能量输出部件可以是电极、超声换能器、激光聚焦透镜及冷冻流体通道中的至少一种。也即，所述能量输出部件所输出的治疗能量可以是一种或者两种以上治疗能量的组合。所述电极用于输出射频。所述超声换能器用于产生超声波。所述激光聚焦透镜用于输出激光。所述冷冻流体通道用于密封在医疗导管10中，并通过传导能量进行冷冻消融。
在一实施例中，治疗部件221包括治疗剂输出部件，所述治疗剂输出部件用于向目标位置释放治疗剂。所述治疗剂输出部件可以是任意合适的结构，如治疗剂输出部件包括药物涂层和药物释放结构中的至少一种。药物释放结构包括给药孔和/或给药微针。需理解，所述给药微针设置在远端管体的外周面上，可以事先存储药物，也可以经给药通道给药。所述药物涂层设置在远端管体的外周面。所述给药孔设置在远端管体的外周面上并穿透管壁与给药通道连通。所述治疗剂输出部件释放治疗剂的方式可以是一种或两种以上的组合，如既设置药物涂层，又设置药物释放结构。需说明的是，所述能量输出部件和治疗剂输出部件可以同时设置或者择一设置。
当治疗部件221包括能量输出部件时，远端部分220优选还包括测温部件(未图示)，所述测温部件用于获取能量治疗过程中目标组织(如消融组织)表面温度，保证合适的能量输出。由于测温部件可获得更为准确的病灶的温度信息，由此改善治疗效果。所述测温部件可以是任意合适的结构，可以为诸如：热电偶、热敏电阻或者热信号采集镜头。所述测温部件可以采用热电偶、热敏电阻以及热信号采集镜头中的至少一种结构。在本申请实施例中，所述能量输出部件包括电极，所述测温部件设置在电极上，并直接监控电极表面温度，以根据电极表面温度确定目标组织表面温度。
作为一改进方案，如图5a和图5b所示，导管主体2还包括轴向延伸设置的控温流体通道22，控温流体通道22和成像通道21分开设置。
如图4所示，在一实施方式中，远端部分220还包括控温流体输出孔224，控温流体输出孔224设置在电极上。控温流体通道22的远端与控温流体输出孔224连接，近端延伸至导管主体2的近端，例如控温流体通道22的近端与接口部1连接。控温流体通道22用于输送控温流体。控温流体输出孔224用于向目标组织(如消融组织)释放具有一定温度的控温流体(如热流体或冷流体)，以此减小组织的过热损伤或过冷损伤。因此，在能量治疗过程中，可以借助于控温流体通道22，向目标组织输送冷或热流体，以维持医疗导管10与目标组织接触面的温度在正常体温范围内，从而保护非治疗区域，增加治疗过程的安全性。控温流体输出孔224的孔径若太大，则会影响电极整体形状影响消融；控温流体输出孔224的孔径若太小，则会导致因流体粘度太高而无法流出微孔的问题。优选地，控温流体输出孔224为微孔，所述微孔的孔径为50μm～200μm。微孔的设置，可以减小控温流体输出时对电极的影响。控温流体的温度可以根据实际需要调整，例如可以为15℃～30℃。控温流体的温度和能量输出功率可以同时调整，以此达到完整的保护内皮的消融功效。
作为一实施方式，如图5a和图5b所示，导管主体2还包括轴向延伸设置的温控导线 通道23和电极导线通道24，两者独立设置。温控导线通道23和电极导线通道24均设置于成像通道21的外部。在一实施方式中，成像通道21、控温流体通道22、温控导线通道23、电极导线通道24和控弯通道25各自独立地分开设置，互不干扰和互不影响。控弯通道25、温控导线通道23、电极导线通道24以及控温流体通道22可以设置在同一圆周上，也就是说，这些通道的中心在同一圆周上，并均围绕成像通道21布设。控弯通道25、温控导线通道23、电极导线通道24以及控温流体通道22也可以设置在不同圆周上，对此不限定。
所述测温部件与控温导线6的远端连接，控温导线6的近端穿过温控导线通道23并延伸至导管主体2的近端，例如与接口部1连接，具体与接口部1中的电信号接口13连接。所述电极与电极导线7的远端连接，电极导线7的近端穿过电极导线通道24并延伸至导管主体2的近端，例如与接口部1连接，具体可与电信号接口13连接。
此外，当治疗部件221包括治疗剂输出部件时，导管主体2还包括轴向延伸设置的给药通道(未图示)。所述给药通道设置在成像通道21的外部。所述给药通道的远端与药物释放结构连接，近端与接口部1连接。此时，所述给药通道用于输送药物，所述药物释放结构包括给药孔和/或给药微针，并用于向目标组织释放药物。
本申请对导管主体2中各个通道的形成方式不作特殊要求。在一实现方式中，导管主体2可以直接为多腔管，各个腔室直接作为通道使用。或者导管主体2为单腔管，并在导管主体2的内部设置若干隔板互相隔离出若干通道。又或者是导管主体2为单腔管，并在导管主体2的内部包裹若干小管子作为通道。无论何种结构，导管主体2应具备适当的强度以支撑各个通道。导管主体2中的所有通道可以彼此间隔地设置，也可以彼此紧挨设置，或者彼此紧挨设置时还彼此固定连接。
在一具体实施方式中，如图2所示，接口部1包括流体灌注接口11、成像接口12、电信号接口13(包括电流接口)和机械动力传导接口14。流体灌注接口11用于与流体灌注设备连接，以向医疗导管10注入控温流体，控温流体一般为生理盐水，如冷盐水。成像接口12用于与成像系统连接，成像系统向医疗导管10输出成像用的能量，并接收从医疗导管10反馈回的采集信号以获取图像并可进行显示。电信号接口13用于与能量输出系统连接，如射频系统，所述能量输出系统向医疗导管10输出治疗能量，如射频能量。电信号接口13还可以向医疗导管10输出温度监控用的电能。电信号接口13还可以与外部的控制系统连接，控制系统接收从医疗导管10反馈回的温度信号。机械动力传导接口14用于与驱动设备连接，所述驱动设备驱动成像诊断部件222旋转和移动，以便调整成像探头2221的位置和朝向，从而对准需监控的目标部位进行成像。
在一实施方式中，所述能量输出部件包括电极，用于输出射频能量，以实现射频消融。电极可以是一个或多个。电极的数量优选为多个，多个电极沿导管主体2的轴向和/或周向间隔排布。电极可以是环形电极或非环形电极。当电极为环形时，可适用于同心弥漫斑块消融。当电极为非环形时，适用于偏心斑块消融。本申请实施例提供的医疗导管10优选同时集成了环形电极和非环形电极，使得医疗导管10能够对不同位置的病灶进行治疗，以满足临床不同的治疗需求。
电极可以是环状或条状，且可以制备成片状结构或网状结构。电极可以具有显影性或不具有显影性，对此不作要求。本申请对电极的材料没有特殊限定，如可以采用铂铱合金、铂金、铜、铁或不锈钢等材料制作射频电极。此外，电极之间需要存在一定的绝缘距离，绝缘距离不宜过小和过大。产生脉冲电场时，由于脉冲电场在正电极和负电极间以正负电极信号释放，此时，若电极间绝缘距离过小，易产生电火花现象及低温等离子效应，若绝缘距离过大，则会对电场强度产生影响。为此，电极之间的绝缘距离不能随意地设置，绝缘距离应保证电场能量强度并且不产生电离，确保作用在病变处的能量和安全性。在一实 施方式中，电极之间的绝缘距离为1mm～5mm，以便精确地控制消融范围，并避免电极距离太近而出现放电现象。电极的大小可以根据实际需求设置。在一实施方式中，电极沿医疗导管10轴向的宽度为2mm～10mm，电极沿医疗导管径向的厚度可以为0.05mm～0.5mm。需理解，电极尺寸应根据病灶部位的大小设定，一般地，电极尺寸越大，消融范围越大。鉴于斑块的尺寸通常在1mm左右，故而电极的轴向宽度设置为2mm～10mm时基本可以满足治疗需求。
如图3和图4所示，并结合图5a～图5c，以两个电极为示意，两个电极分别为近端电极225和远端电极226，近端电极225和/或远端电极226上设置有控温流体输出孔224。优选地，首先近端电极225上设置控温流体输出孔224，并经由近端电极225上的控温流体输出孔224释放控温流体，使控温液体灌满近端电极225和远端电极226之间的整个消融区。在图示的实施方式中，近端电极225和远端电极226均为环形电极，两者在轴向上间距一定距离设置，且成像探头2221设置在近端电极225和远端电极226之间。近端电极225和远端电极226之间的区域作为消融区，对病灶进行射频消融，同时成像探头2221在消融区监控病灶的治疗效果。在一实施方式中，调弯牵引体41的远端连接于远端管体对应于近端电极225的近端位置。
每个电极上焊接有电极导线7，电极导线7具体焊接在电极的内表面，电极导线7的远端可穿过管壁与电极内表面连接。电极导线7的材料应根据需求设置，如根据不同长度阻抗值选择电极导线7的材料。电极导线7和温控导线6可以共用同一个电信号接口13，或者两者采用独立的两个电信号接口13。
医疗导管10的外径应根据所介入腔道的管径设定。可选第，医疗导管10的外径可以为1.0mm～10.0mm，以适应全身疾病。进一步地，医疗导管10的外径不超过2mm，以解决在更小尺寸下的消融斑块治疗问题。所应理解，医疗导管10的外径主要指导管主体2、连接部5和头端3的外径，导管主体2和连接部5的外径通常是相同的，头端3的近端外径与导管主体2的外径也是相同的。
在一具体的应用场景中，本实施例所涉及的医疗导管10应用于冠脉血管，此时，导管主体2的外径为1.0mm～3.0mm，优选1.8mm～2.0mm。如果导管主体2的外径超过3.0mm，则尺寸过大，难以介入冠脉血管，如果导管主体2的外径小于1.0mm，则难以在其内部集成各个通道，增加工艺难度。导管主体2的壁厚可以为0.1mm～0.5mm，在确保医疗导管10整体强度的同时，还确保医疗导管10有较好的柔顺性。进一步地，成像通道21的直径不超过1.0mm，控温流体通道22的直径不超过0.5mm，电极导线通道24的直径为0.1mm～0.5mm，温控导线通道23的直径为0.1mm～0.5mm；通过对各个通道直径的控制，在能够充分容纳各部分结构时，还减小了各部分结构之间的相互影响，确保各个功能能够正常操作并实现。
作为一具体实施例，如图3～图4以及图5a～图5c所示，医疗导管10作为消融导管使用，并且采用OCT成像以及射频消融，其应用于动脉粥样硬化斑块的适形治疗。在该实施例中，导管主体2的外径为2.0mm，导管主体2中设置有一个成像通道21、一个控温流体通道22、两个温控导线通道23、两个电极导线通道24以及四个控弯通道25，测温部件选用热电偶，电极为环形电极且数量为两个，两个环形电极沿导管主体2的轴向间隔布设，两个环形电极由铂铱合金制成，厚度均为0.1mm，轴向宽度为2.0mm，两个环形电极之间为透明的成像窗口223，成像窗口223的总长度为50mm，成像探头2221设置在两个环形电极之间，每个环形电极上焊接有电极导线7和温控导线6，温控导线6由铜镍合金制成，电极导线7由铂铱合金制成，两路温控导线6和两路电极导线7分布在成像通道21的四周，相对于成像通道21对称分布，每个环形电极上设置有控温流体输出孔224，控温流体输出孔224的数量为12个，孔径为90μm，并沿电极的周向均匀布设，调弯牵引体41的 数量为四个，四个调弯牵引体41与四个控弯通道25一一对应地设置，四根调弯牵引体41的近端分别连接四个控弯件42，远端连接至远端管体上对应于近端电极225的近端所处的位置，控温流体通道22、两个温控导线通道23、两个电极导线通道24以及四个控弯通道25布设在成像通道21的周围，成像通道21设置在医疗导管10的中心位置，控温流体通道22、两个温控导线通道23、两个电极导线通道24以及四个控弯通道25设置在同一个圆周上，以减小导管整体外径，成像通道21的直径为0.5mm，控温流体通道22的直径为0.3mm，两个温控导线通道23相对于成像通道21对称设置，两个电极导线通道24也相对于成像通道21对称设置。如此设置，可以较好地解决光、电和热在医疗导管10上集成兼容的问题，并且减小了这些结构之间的相互影响和相互干扰。
此外，手术过程中，导引导丝经由头端3的导丝腔31，将消融导管输送到血管中。头端3为快速交换式设计，通过将导丝腔31前置，可以快速进行介入器械更换以及降低导管整体设计尺寸。导丝腔31的直径为0.5mm；头端3的轴向长度为30mm。头端3通过聚氨酯制备的连接部5与远端部分220连接，如粘合连接。连接部5的外径为2.0mm，轴向长度为20mm。另外，在消融治疗过程中，成像接口12和机械动力传导接口14集成为一体，将此集成式接口接入成像系统，成像诊断部件222通过成像光纤与梯度折射率透镜组合发射激光与采集血管反射光信号，对射频消融的治疗过程进行监控；成像探头2221选用梯度折射率(GRIN)透镜，梯度折射率透镜设置在两个环形电极之间，可通过成像窗口223接收和发射光束；成像光纤在成像通道21内随着驱动设备进行轴向移动和旋转，同时通过梯度折射率透镜进行光信号的发射与采集。在消融治疗过程中，冷盐水由流体灌注设备经流体灌注接口11进入控温流体通道22，通过电极上的控温流体输出孔224，流到病灶处，在射频消融过程中降温，保护内皮细胞；冷盐水可进行流量大小调控，以满足不同的降温需求。
本实施例的医疗导管10可依据如下方式使用，具体包括：
(1)将成像接口12接入成像系统，电信号接口13接入能量输出系统，流体灌注接口11接入流体灌注设备，机械动力传导接口14接入驱动设备；
(2)整根医疗导管10经由导引导丝输送到病变血管段，然后，开启成像系统，对病变区域进行成像分辨病灶位置和病灶组分；
(3)经过成像诊断后，将远端部分220输送到指定病灶位置，然后，调整控弯部件4，使远端部分220相对于近端部分210产生一定角度与方向，使得远端部分220与病灶紧密贴合；
(4)远端部分220与病灶紧密贴合后，开启能量输出系统，将治疗能量或者治疗剂靶向释放到病灶部位，在此期间，成像探头2221通过成像窗口223持续监控指定部位的治疗效果或者治疗剂释放程度；
(5)待一处病灶治疗完毕，释放远端部分220，使远端部分220恢复原状，然后移动医疗导管10至下一处重复上述过程进行治疗；
(6)病变区域全部治疗完毕，对治疗区域段再进行整段成像扫描评估治疗效果；
(7)最后经由导引导丝，撤出整根医疗导管10，完成治疗过程。
更详细地，参见图6和图7，手术之前，将接口部1中的各个接口与对应的成像系统、射频系统和流体灌注设备连接。然后，将医疗导管10沿着头端3的导丝腔31经由导引导丝30输送到血管中，并通过机械力控制成像光纤和成像探头2221在成像通道21中移动和旋转，成像探头2221发射激光并采集血管反射回的光信号，成像系统使用OCT分析对血管进行成像并分析斑块20形貌及成分；然后，根据成像结果，将电极对齐需消融部位；拉动控弯件42调整远端部分220的弯曲角度，以使远端部分220紧密贴合纤维斑块20，见图7；然后，打开射频系统，通过电信号接口13施加射频电流，在斑块20内产生阻抗 热，对血管斑块进行消融，在该过程中，成像光纤持续旋转采集实时信号成像，监控消融程度，且电极表面的热电偶实时监测消融温度，同时不断从控温流体输出孔224灌注冷盐水冲刷电极与消融组织表面，调节温度，减少内皮细胞的损伤。在对一处消融完成后，释放远端部分220(参见图6)，将医疗导管10移至下一处病灶进行相同的消融处理。治疗完毕后，对整段血管进行OCT成像评估治疗效果。最后，回撤导管，完成手术。
特别需要说明的是，本发明实施例的消融导管不限于为射频消融导管，也可以是冷冻消融导管。若为冷冻消融导管，需要在导管主体2的内部设置冷冻流体通道，冷冻流体通道的远端设置出口，并用于向球囊内表面喷射冷冻液体，此时可在远端部分220上外套球囊。还需理解，在现有技术中，并没有在血管腔内成像和温控指导下针对粥样硬化斑块的射频消融。而本发明提供的医疗导管的外径可做到不大于2mm，此时，可以解决在更小尺寸下的热消融斑块治疗问题，并通过成像、温度监控和射频消融有效地结合，使射频消融更为精准，消融效果更好。尤其在外径小于10mm，特别是2mm以下的医疗导管中增加了控弯功能，实现了治疗与病灶空间形状适形匹配的目的，可以更精准靶向治疗，提升治疗效果。
综上所述，本发明提供的医疗导管可以通过一种或多种方式对血管疾病、心脏疾病等进行诊断和治疗，如在治疗前使用OCT成像制定治疗计划，治疗过程中，OCT成像和温度监控实时反馈治疗效果，治疗结束后再整体评估治疗效果，有效地改善治疗效果。并且在制备医疗导管时，将导管分段设置并利用功能部的嵌套，解决了狭小物理空间的组件分布与功能实现的技术难题，实现了一管多功能以及诊疗一体。该医疗导管应用后可以有效提高预期临床效果。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (19)

  1. 一种医疗导管，其特征在于，包括导管主体和控弯部件，所述导管主体包括近端部分以及位于所述导管主体远端的远端部分，所述远端部分用于成像监控，还用于释放治疗能量和/或治疗剂，所述远端部分与所述控弯部件连接，并用于在所述控弯部件的控制下相对于所述近端部分弯曲。
  2. 根据权利要求1所述的医疗导管，其特征在于，所述远端部分包括远端管体，所述近端部分包括近端管体，所述远端管体的硬度小于所述近端管体的硬度。
  3. 根据权利要求1或2所述的医疗导管，其特征在于，所述控弯部件包括调弯牵引体和控弯件，所述控弯件设置在所述导管主体的近端，所述调弯牵引体的远端与所述远端部分连接，所述调弯牵引体的近端穿过所述导管主体后与所述控弯件连接，所述调弯牵引体用于在所述控弯件的驱动下控制所述远端部分弯曲。
  4. 根据权利要求3所述的医疗导管，其特征在于，所述调弯牵引体的数量为多个，多个所述调弯牵引体围绕所述导管主体的中心轴线沿周向均匀布设。
  5. 根据权利要求4所述的医疗导管，其特征在于，每个所述调弯牵引体与至少一个所述控弯件连接，不同的所述调弯牵引体连接不同的所述控弯件。
  6. 根据权利要求3所述的医疗导管，其特征在于，还包括接口部，所述近端部分的近端连接所述接口部，所述控弯件可活动地设置在所述接口部上。
  7. 根据权利要求3所述的医疗导管，其特征在于，所述导管主体还包括轴向延伸设置的控弯通道，所述调弯牵引体在所述控弯通道中穿行。
  8. 根据权利要求1或2所述的医疗导管，其特征在于，所述控弯部件包括磁响应形变部件和/或光致形变部件，所述磁响应形变部件由磁响应材料制成，能够在磁场作用下产生形变，所述光致形变部件由光响应材料制成，能够在吸收光能后产生光致形变。
  9. 根据权利要求1或2所述的医疗导管，其特征在于，还包括接口部，所述近端部分的近端连接所述接口部，所述接口部用于与对应的外部设备连接，以输入和输出信息。
  10. 根据权利要求1或2所述的医疗导管，其特征在于，所述远端部分包括成像诊断部件和治疗部件，所述成像诊断部件用于成像监控，所述治疗部件用于释放治疗能量和/或治疗剂；
    所述成像诊断部件包括成像探头，所述导管主体还包括轴向延伸设置的成像通道，所述成像通道中设置有与所述成像探头连接的成像传输结构，所述成像通道的中心轴线与所述导管主体的中心轴线重合。
  11. 根据权利要求10所述的医疗导管，其特征在于，所述远端部分还包括成像窗口，所述成像探头设置在所述成像窗口处。
  12. 根据权利要求10所述的医疗导管，其特征在于，所述成像探头为光学探头，所述成像传输结构包括成像光纤、保护管和扭力弹簧，所述保护管套设于所述成像光纤上，所述扭力弹簧设置在所述保护管和所述成像光纤之间，所述成像光纤的一端连接所述成像探头，另一端沿所述成像通道延伸至所述导管主体的近端。
  13. 根据权利要求12所述的医疗导管，其特征在于，还包括接口部，所述近端部分的近端连接所述接口部，所述接口部包括成像接口以及机械动力传导接口，所述成像光纤的所述另一端连接所述机械动力传导接口和所述成像接口，所述成像诊断部件用于在驱动设备驱动下沿所述导管主体的周向旋转和/或沿所述导管主体的轴向移动。
  14. 根据权利要求10所述的医疗导管，其特征在于，所述治疗部件包括能量输出部件，所述能量输出部件能够输出射频、超声波、激光及冷冻流体中的至少一种治疗能量，和/或，所述治疗部件包括治疗剂输出部件，所述治疗剂输出部件包括药物涂层和药 物释放结构中的至少一种，所述药物释放结构包括给药孔和/或给药微针。
  15. 根据权利要求14所述的医疗导管，其特征在于，所述治疗部件包括所述能量输出部件，所述能量输出部件包括电极，所述远端部分还包括设置在所述电极上的测温部件，所述测温部件用于获取电极表面温度。
  16. 根据权利要求15所述的医疗导管，其特征在于，所述导管主体还包括轴向延伸设置的控温流体通道，所述远端部分还包括控温流体输出孔，所述控温流体输出孔设置在所述电极上，所述控温流体通道的远端与所述控温流体输出孔连接，所述控温流体通道用于输送控温流体。
  17. 根据权利要求15所述的医疗导管，其特征在于，所述导管主体还包括轴向延伸设置的温控导线通道和电极导线通道，所述测温部件与控温导线的远端连接，所述控温导线的近端穿过所述温控导线通道并延伸至所述导管主体的近端；所述电极与电极导线的远端连接，所述电极导线的近端穿过所述电极导线通道并延伸至所述导管主体的近端。
  18. 根据权利要求14所述的医疗导管，其特征在于，所述能量输出部件包括电极，所述电极用于输出射频，所述电极的数量为多个并沿所述导管主体的轴向和/或周向间隔排布。
  19. 根据权利要求1或2所述的医疗导管，其特征在于，所述远端部分的远端通过弹性连接部连接头端，所述头端设置有导丝腔。
PCT/CN2023/117991 2022-09-15 2023-09-11 医疗导管 Ceased WO2024055927A1 (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP23864659.0A EP4588427A4 (en) 2022-09-15 2023-09-11 MEDICAL CATHETER

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211123870.9 2022-09-15
CN202211123870.9A CN115463307B (zh) 2022-09-15 2022-09-15 医疗导管

Publications (1)

Publication Number Publication Date
WO2024055927A1 true WO2024055927A1 (zh) 2024-03-21

Family

ID=84333700

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/117991 Ceased WO2024055927A1 (zh) 2022-09-15 2023-09-11 医疗导管

Country Status (3)

Country Link
EP (1) EP4588427A4 (zh)
CN (1) CN115463307B (zh)
WO (1) WO2024055927A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120586293A (zh) * 2025-06-23 2025-09-05 中国人民解放军总医院第二医学中心 基于短波紫外线照射的胃部疾病治疗仪

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115463307B (zh) * 2022-09-15 2025-10-17 上海微创医疗器械（集团）有限公司 医疗导管
CN115463308B (zh) * 2022-09-15 2025-09-26 上海微创医疗器械（集团）有限公司 医用介入导管
CN116531078A (zh) * 2023-03-09 2023-08-04 中国医学科学院阜外医院 具有超声探测功能的消融导管
CN119950007A (zh) * 2025-01-22 2025-05-09 融和医疗科技(浙江)有限公司 一种脉冲消融装置

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060247522A1 (en) * 2005-04-28 2006-11-02 Boston Scientific Scimed, Inc. Magnetic navigation systems with dynamic mechanically manipulatable catheters
CN103830002A (zh) * 2012-11-23 2014-06-04 四川锦江电子科技有限公司 可控弯螺旋灌注导管
CN106691405A (zh) * 2016-12-29 2017-05-24 天津恒宇医疗科技有限公司 一种超细oct成像导管
CN109758674A (zh) * 2019-01-23 2019-05-17 武汉布润脑医学科技有限责任公司 一种脑胶质瘤诊疗装置
CN114424971A (zh) * 2022-01-26 2022-05-03 上海鑫律通生命科技有限公司 一种可双向弯曲的花键篮消融导管
CN114469275A (zh) * 2022-01-18 2022-05-13 蓝线铂立生命科技(苏州)有限公司 可视穿刺射频消融系统
CN114788729A (zh) * 2021-01-24 2022-07-26 中国人民解放军北部战区总医院 一种集超声成像与射频消融于一体的导管
CN114949553A (zh) * 2021-02-22 2022-08-30 石益海 一种可视化导管及带有该可视化导管的切开刀
CN115363709A (zh) * 2022-08-18 2022-11-22 苏州市独墅湖医院(苏州大学附属独墅湖医院) 一种可调弯的血管内超声引导式穿刺方法
CN115463307A (zh) * 2022-09-15 2022-12-13 上海微创医疗器械（集团）有限公司 医疗导管

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102198305B (zh) * 2010-03-23 2013-06-05 上海微创医疗器械（集团）有限公司 用于局部输送治疗剂的装置和系统
WO2015164437A1 (en) * 2014-04-21 2015-10-29 Clph, Llc Imaging apparatus and systems and methods for using them
JP2017536187A (ja) * 2014-12-03 2017-12-07 メタベンション インコーポレイテッド 神経または他の組織を調節するためのシステムおよび方法
US10568687B2 (en) * 2015-01-16 2020-02-25 The Regents Of The University Of California Integrated intraoperative diagnosis and thermal therapy system
CN204562076U (zh) * 2015-03-05 2015-08-19 上海安清医疗器械有限公司 鼻咽镜
CN108294821A (zh) * 2018-01-24 2018-07-20 深圳市凯思特医疗科技股份有限公司 激光成像靶向消融导管
CN108245726B (zh) * 2018-03-05 2024-08-13 温州市中心医院 一种腹膜透析管用漂管矫正器
WO2020002177A1 (en) * 2018-06-28 2020-01-02 Koninklijke Philips N.V. Internal ultrasound assisted local therapeutic delivery
CN114073577B (zh) * 2020-08-17 2024-10-29 上海微创电生理医疗科技股份有限公司 医疗导管
CN112842522A (zh) * 2021-01-27 2021-05-28 北京航空航天大学 一种血管内光学相干断层成像激光消融导管
CN114903491A (zh) * 2021-02-09 2022-08-16 上海微创电生理医疗科技股份有限公司 医疗导管
CN219110541U (zh) * 2022-09-15 2023-06-02 上海微创医疗器械（集团）有限公司 医疗导管

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060247522A1 (en) * 2005-04-28 2006-11-02 Boston Scientific Scimed, Inc. Magnetic navigation systems with dynamic mechanically manipulatable catheters
CN103830002A (zh) * 2012-11-23 2014-06-04 四川锦江电子科技有限公司 可控弯螺旋灌注导管
CN106691405A (zh) * 2016-12-29 2017-05-24 天津恒宇医疗科技有限公司 一种超细oct成像导管
CN109758674A (zh) * 2019-01-23 2019-05-17 武汉布润脑医学科技有限责任公司 一种脑胶质瘤诊疗装置
CN114788729A (zh) * 2021-01-24 2022-07-26 中国人民解放军北部战区总医院 一种集超声成像与射频消融于一体的导管
CN114949553A (zh) * 2021-02-22 2022-08-30 石益海 一种可视化导管及带有该可视化导管的切开刀
CN114469275A (zh) * 2022-01-18 2022-05-13 蓝线铂立生命科技(苏州)有限公司 可视穿刺射频消融系统
CN114424971A (zh) * 2022-01-26 2022-05-03 上海鑫律通生命科技有限公司 一种可双向弯曲的花键篮消融导管
CN115363709A (zh) * 2022-08-18 2022-11-22 苏州市独墅湖医院(苏州大学附属独墅湖医院) 一种可调弯的血管内超声引导式穿刺方法
CN115463307A (zh) * 2022-09-15 2022-12-13 上海微创医疗器械（集团）有限公司 医疗导管

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4588427A4 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120586293A (zh) * 2025-06-23 2025-09-05 中国人民解放军总医院第二医学中心 基于短波紫外线照射的胃部疾病治疗仪

Also Published As

Publication number Publication date
CN115463307A (zh) 2022-12-13
CN115463307B (zh) 2025-10-17
EP4588427A1 (en) 2025-07-23
EP4588427A4 (en) 2026-01-14

Similar Documents

Publication Publication Date Title
WO2024055927A1 (zh) 医疗导管
US11413089B2 (en) Ablation techniques for the treatment of atrial fibrillation
JP6153751B2 (ja) 複合式構成体を有するカテーテル
CN105920717B (zh) 具有流体旋转接头的医疗探针
JP6453769B2 (ja) 高周波焼灼方法、システム及び高周波焼灼設備
US12594438B2 (en) Bronchial denervation using integrated a-mode signal for optimization of ultrasound treatment
US20160287912A1 (en) Method and apparatus for performance of thermal bronchiplasty with unfocused ultrasound
CN112842522A (zh) 一种血管内光学相干断层成像激光消融导管
CN101902972A (zh) 图像引导的脉管内治疗导管
CN219110541U (zh) 医疗导管
WO2024055929A1 (zh) 医用介入导管
CN219941532U (zh) 医用介入导管
CN216823634U (zh) 一种针对肥厚型心肌病的治疗针组件及治疗系统
CN219538476U (zh) 一种消融导管、消融装置及消融系统
CN210697913U (zh) 一种可膨胀式带薄膜测温的食管偏转装置
CN116269735A (zh) 一种对靶标神经消融的装置
CN120203750B (zh) 一种血管介入射频脉冲消融手术系统
JP2001079016A (ja) 加熱治療装置
CN120420003A (zh) 一种血管内成像以及治疗的超声消融导管、治疗系统
CN119925842A (zh) 消融导管及消融设备

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23864659

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2023864659

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2023864659

Country of ref document: EP

Effective date: 20250415

WWP Wipo information: published in national office

Ref document number: 2023864659

Country of ref document: EP