CN-122005004-A - Modularized intravascular treatment system and method based on imaging platform

CN122005004ACN 122005004 ACN122005004 ACN 122005004ACN-122005004-A

Abstract

The invention discloses a modularized intravascular treatment system and a modularized intravascular treatment method based on an imaging platform, comprises a universal operating handle, at least one replaceable treatment module, a modularized instrument interface and an imaging probe. The general operation handle is internally provided with a guide wire channel and at least one fluid channel, and the treatment module is arranged at the far end of the system and is axially communicated with the guide wire channel and is detachably connected with the general operation handle through a modularized instrument interface. The imaging probe may be selectively disposed within the universal operating handle or at the front end of the treatment module and is axially coaxially disposed with the treatment module after assembly of the system, with the axial position thereof being defined as a preset imaging reference position relative to the treatment module. Through the structural configuration, under the condition that the guide wire is not replaced and the system is not wholly withdrawn, continuous imaging monitoring of a corresponding treatment area in the treatment operation process is realized, and the operation consistency and the imaging consistency of the intervention treatment in the blood vessel cavity are improved.

Inventors

GAO BIN
LI ZHEYUN
Mao le
LIU DIEFAN
XIE TIANCHEN
FU WEIGUO

Assignees

上海市老年医学中心

Dates

Publication Date: 20260512
Application Date: 20260212

Claims (10)

1. A modular endovascular therapy system based on an imaging platform, comprising: the universal operation handle comprises a catheter outer sheath (2), a handle guide wire channel (9) arranged in the catheter outer sheath (2) and at least one fluid channel which is axially arranged and communicated with an external fluid source; At least one treatment module arranged at the far end of the system, wherein a treatment passage which is axially communicated with the handle guide wire channel (9) is arranged in the treatment module and is used for performing intracavity treatment operation on a target blood vessel segment under the guidance of a guide wire; The modularized instrument interface (1) is arranged at the far end of the universal operation handle, is used for enabling the universal operation handle to be detachably connected with the treatment module, and limiting the axial assembly position of the treatment module relative to the universal operation handle in an assembly state, so that the handle guide wire channel (9) and the fluid channel are respectively and continuously communicated with corresponding channels in the treatment module; The imaging platform is used for carrying out imaging evaluation on the blood vessel intracavity region corresponding to the treatment module and comprises an imaging probe and an imaging passage (5) communicated with the imaging probe, wherein the imaging probe is axially arranged along the system and can be selectively arranged at any one of the following positions: The device is arranged in the general operating handle and positioned in the proximal direction of the treatment module, or arranged at the front end of the treatment module and positioned in the distal direction of the treatment module; Wherein the imaging probe is coaxially arranged with the treatment module after the universal operating handle and the treatment module are assembled, and the axial position of the imaging probe is defined as a preset imaging reference position relative to the treatment module.
2. The modular endovascular therapy system defined in claim 1, wherein the predetermined imaging reference position is in an axially-opposed position configuration defining a fixed spacing between the imaging probe and the therapy module, wherein, The fixed spacing is defined structurally after the universal operating handle and the treatment module are assembled and remains unchanged during treatment module replacement or treatment operations, the treatment module being held in a predetermined angular orientation relative to the universal operating handle in an assembled state and the treatment module internal passageway being held in a predetermined aligned relationship with a corresponding passageway in the universal operating handle.
3. The modularized intravascular treatment system based on the imaging platform, as set forth in claim 1, characterized in that the imaging platform is an IVUS intravascular ultrasonic imaging platform, the imaging probe is an ultrasonic imaging probe and is electrically connected with an external ultrasonic imaging processing unit through the imaging passage (5) for obtaining the section structure information of the blood vessel cavity and the blood vessel wall in a blood environment, the imaging passage, the treatment passage and the liquid passage which are independent and physically isolated from each other are axially arranged in the treatment module, and each passage is kept in a fixed relative position in the treatment module and is respectively communicated with the corresponding passage in the universal operation handle one by one at the proximal end of the treatment module through the modularized instrument interface (1).
4. The modularized blood vessel intracavity treatment system based on the imaging platform is characterized in that the imaging platform is an OCT optical coherence tomography imaging platform, the imaging probe is an optical imaging probe and is in optical connection with an external optical imaging processing unit through an imaging passage (5) for acquiring imaging information of a high-resolution structure in a blood vessel cavity, an imaging passage, a treatment passage and a liquid passage which are independent and physically isolated from each other are axially arranged in the treatment module, and each passage is kept in a fixed relative position in the treatment module and is respectively communicated with a corresponding passage in the universal operation handle one by one at the proximal end of the treatment module through a modularized instrument interface (1).
5. The modular vascular luminal treatment system of claim 2 in which the imaging probe is disposed in the anterior direction of the atherectomy device (23) and the imaging passageway and the atherectomy passageway are disposed axially side-by-side within the treatment module such that the imaging location is axially forward of the atherectomy region when the treatment module is an atherectomy module.
6. The modular endovascular therapy system defined in claim 5, wherein the fluid pathway of the atherectomy module comprises an inlet fluid pathway (24) and a outlet fluid pathway (25), the inlet fluid pathway (24) and the outlet fluid pathway (25) being located at different lateral positions of the atherectomy pathway, respectively, to form a directional fluid flow path in the atherectomy region.
7. The imaging-platform-based modular endovascular treatment system of claim 1, wherein the universal operating handle is assembled with a plurality of different types of treatment modules including at least one of a balloon module, a stent delivery module, a atherectomy module, or a thrombus aspiration module; After the treatment modules of different types are assembled with the universal operation handle, the internal imaging passages of the treatment modules are coaxially aligned with the imaging passages in the universal operation handle in the axial direction, so that the imaging probes are positioned at the preset imaging reference positions in different treatment module assembling states; the imaging probe comprises a handle front end imaging probe (11) and a treatment module front end imaging probe (14), wherein: the imaging probe (11) at the front end of the handle is arranged in the universal operation handle and positioned in the proximal direction of the treatment module and is used for imaging and evaluating the distal vessel segment of the action area of the treatment module; the treatment module front end imaging probe (14) is arranged at the front end of the treatment module and is positioned in the distal end direction of the treatment module, so that an imaging view field is positioned in front of the treatment module action area in the axial direction.
8. A method of operating an imaging platform based modular endovascular therapy system, based on the implementation of any one of claims 1-7, characterized by the steps of: the universal operation handle is assembled and connected with the selected treatment module through the modularized instrument interface, so that the treatment module is communicated with the handle guide wire channel and the fluid channel, and the axial assembly position of the treatment module relative to the universal operation handle is limited after the assembly is completed; under the guidance of a guide wire, the assembled system is sent into a target lesion area along a vascular access, so that the imaging probe is positioned at a preset imaging reference position relative to the treatment module in the system assembling state; under the condition that the guide wire is not withdrawn, imaging evaluation is carried out on the lesion area through the imaging probe so as to acquire intracavity imaging information of the lesion area corresponding to the treatment module; Maintaining the axial relative position between the imaging probe and the treatment module unchanged, and driving the treatment module to execute corresponding intracavity treatment operation in the lesion area; And according to the result of imaging evaluation after treatment, replacing another treatment module under the condition of not withdrawing the universal operation handle and the guide wire, and repeating the steps until the multi-stage intracavity treatment operation is completed.
9. The method according to claim 8, wherein the imaging probe is positioned at a preset imaging reference position with respect to the treatment module by integrally pushing or retracting the universal operation handle when the imaging probe is disposed inside the universal operation handle, or the imaging probe is automatically positioned at the preset imaging reference position in an assembled state by pushing the treatment module when the imaging probe is disposed at the front end of the treatment module.
10. The method of claim 8, wherein the multi-stage endovascular treatment comprises a rotational atherectomy, a balloon dilation, and a stent implantation performed sequentially, wherein the imaging probe is used to image the same lesion region before and after each stage of treatment module replacement, so as to perform a comparison of the treatment effects of the different treatment stages.

Description

Modularized intravascular treatment system and method based on imaging platform Technical Field The invention relates to the technical field of medical instruments and interventional diagnosis and treatment, in particular to a modularized intravascular treatment system and method based on an imaging platform. Background With the development of vascular interventional technology, the intracavitary treatment means such as balloon dilatation, stent implantation, thrombus aspiration, plaque rotary cutting and the like have been widely applied to the clinical treatment of peripheral vascular diseases and coronary artery diseases. In order to improve the safety and accuracy of the endoluminal procedure, the intravascular imaging technique can provide high resolution cross-sectional images of the lumen and wall structures of the vessel, which are used progressively for lesion assessment and efficacy judgment before and after interventional therapy. However, existing intravascular imaging devices are typically used as stand-alone imaging catheters, whose primary function is to morphologically visualize intravascular lesions, without forming a structurally or functionally integrated design with the particular intraluminal therapeutic device. In the actual operation process, the operator often needs to repeatedly withdraw and reinsert the catheter between the imaging catheter and various kinds of endoluminal apparatuses such as the balloon catheter, the stent delivery system, the plaque treatment device and the like, so as to complete the lesion evaluation and treatment operation respectively. The operation mode not only remarkably prolongs the operation time, but also increases the mechanical stimulation risk to the inner wall of the blood vessel in the process of exchanging the catheter for many times, thereby improving the occurrence probability of complications such as vascular dissection, thrombus shedding and the like, and simultaneously, repeated catheter exchange is usually accompanied with additional perspective confirmation steps, thereby increasing the radiation exposure dose of patients and operators, improving the using amount of contrast agent and adversely affecting the postoperative recovery of the patients. In addition, the existing intravascular treatment devices mostly adopt an integrated structural design, and different treatment functions generally correspond to different types of special catheters. When the treatment strategy is required to be adjusted according to the pathological change condition in the operation, the whole instrument system is often required to be replaced, the steps of disassembly, flushing, reconnection and the like are involved, the operation flow is complex, the flexibility is insufficient, the instrument redundancy is high, and the whole use cost is high. In view of the above, the invention provides a modularized intravascular treatment system and a modularized intravascular treatment method based on an imaging platform. Disclosure of Invention The invention aims to provide a modularized intravascular treatment system and method based on an imaging platform, and aims to solve the technical problems that in the existing intravascular interventional treatment process, imaging equipment and treatment equipment are mutually independent and catheters need to be exchanged repeatedly, so that the operation flow is complex, the real-time visibility is insufficient, and the operation efficiency and safety are limited. In a first aspect, the present invention provides a modular intravascular treatment system based on an imaging platform, comprising: The universal operation handle comprises a catheter outer sheath, a handle guide wire channel arranged in the catheter outer sheath and at least one fluid channel which is axially arranged and communicated with an external fluid source; At least one treatment module arranged at the far end of the system, wherein a treatment passage which is axially communicated with the handle guide wire channel is arranged in the treatment module and is used for performing intracavity treatment operation on a target blood vessel segment under the guidance of a guide wire; the modularized instrument interface is arranged at the far end of the universal operation handle, is used for enabling the universal operation handle to be detachably connected with the treatment module, and limiting the axial assembly position of the treatment module relative to the universal operation handle in an assembly state, so that the handle guide wire channel and the fluid channel are respectively and continuously communicated with corresponding channels in the treatment module; the imaging platform is used for carrying out imaging evaluation on the blood vessel intracavity region corresponding to the treatment module and comprises an imaging probe and an imaging passage communicated with the imaging probe, wherein the imaging probe is axially arranged along the system and