CN117815518A - Occlusion catheter and medical system - Google Patents

Occlusion catheter and medical system Download PDF

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Publication number
CN117815518A
CN117815518A CN202211194223.7A CN202211194223A CN117815518A CN 117815518 A CN117815518 A CN 117815518A CN 202211194223 A CN202211194223 A CN 202211194223A CN 117815518 A CN117815518 A CN 117815518A
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CN
China
Prior art keywords
lumen
section
tube
expandable
occlusion catheter
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.)
Pending
Application number
CN202211194223.7A
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Chinese (zh)
Inventor
时欣
周炯
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Shentu Medical Technology Shanghai Co ltd
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Shentu Medical Technology Shanghai Co ltd
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Publication date
Application filed by Shentu Medical Technology Shanghai Co ltd filed Critical Shentu Medical Technology Shanghai Co ltd
Priority to CN202211194223.7A priority Critical patent/CN117815518A/en
Priority to PCT/CN2023/119636 priority patent/WO2024067241A1/en
Publication of CN117815518A publication Critical patent/CN117815518A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0052Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1072Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1075Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Reproductive Health (AREA)
  • Molecular Biology (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention provides a plugging catheter and a medical system, comprising: a multi-lumen tube, a first expandable member, and a second expandable member; the first expandable element and the second expandable element are disposed at a set distance apart along an axial direction of the multi-lumen tube; the multi-cavity tube is provided with a liquid passing cavity and a conveying cavity; the access lumen extending distally from the proximal end of the multi-lumen tube and communicating with the lumens of the first and second expandable elements; the delivery lumen is disposed therethrough along an axial direction of the multi-lumen tube from a proximal end of the multi-lumen tube to a location between the first expandable element and the second expandable element, the multi-lumen tube having an opening in a sidewall between the first expandable element and the second expandable element, the opening in communication with the delivery lumen for passage of an instrument therethrough. In the operation process, the plugging catheter is used for real-time protection, so that thrombus in the carotid artery can be prevented from escaping.

Description

Occlusion catheter and medical system
Technical Field
The invention relates to the technical field of medical treatment, in particular to a catheter blocking and a medical system.
Background
Fig. 1 is a partial cross-sectional view of a carotid artery, which is typically characterized by plaque B build-up at the internal carotid vessel (ICA), thereby narrowing the vascular line supplying blood to the cranium. If these built-up plaques are unstable, some of the emboli or particles that they produce may be flushed by blood into the more distal, finer blood vessels within the cranium, which may lead to cerebral ischemia, stroke and even death.
At present, there are two main modes for treating carotid stenosis, one is to perform surgery, dissect carotid exposure and perform carotid intima stripping (CEA). Another approach is to perform interventional procedures, and carotid revascularization (CAS) by placing a stent at the carotid artery through a femoral access.
In CEA surgery, the carotid artery needs to be exposed and cut, which is easy to cause complications such as nerve injury, and has large wound and long postoperative bedridden time. Meanwhile, when CEA treatment is carried out, the upper and lower parts of the focus area are clamped and then operated, and in the operation process, blood supply in the brain is mainly provided by contralateral carotid arteries, and CEA operation is long in operation time, and serious damage can be caused to cerebral vessels due to long-time blood supply deficiency in the brain.
In CAS surgery, the operation time is shorter and the wound is smaller, but in the stent placement process, plaque may be caused to fall off and escape to a far-end finer blood vessel, which further causes complications such as cerebral apoplexy. Although there are remote protection umbrellas for embolic harvesting, the placement and function of the remote protection umbrellas are limited for various reasons. And the placement of the distal protective umbrella requires the protective umbrella to be placed more distally through the focal zone, and is free of any embolic protection prior to placement of the umbrella, which is also an important cause of stroke complications.
Disclosure of Invention
The present invention is directed to a occlusion catheter and medical system that address one or more of the problems of the prior art.
In order to solve the above problems, the present invention provides a plugging catheter, which is characterized in that the plugging catheter comprises: a multi-lumen tube, a first expandable member, and a second expandable member;
the first expandable element and the second expandable element are disposed at a set distance interval to the multi-lumen tube along the extension direction of the multi-lumen tube; the multi-cavity tube is provided with a liquid passing cavity and a conveying cavity; the access lumen extending distally from the proximal end of the multi-lumen tube and communicating with the lumens of the first and second expandable elements; the delivery lumen is disposed therethrough along an axial direction of the multi-lumen tube from a proximal end of the multi-lumen tube to a location between the first expandable element and the second expandable element; the multi-lumen tube has an opening in a sidewall between the first and second expandable members, the opening communicating with the delivery lumen for the passage of an instrument passed through the delivery lumen.
Optionally, in the occlusion catheter, the liquid passing cavity includes a first chamber and a second chamber, and the first chamber and the second chamber are respectively communicated with the inner cavities of the first expandable element and the second expandable element.
Optionally, in the plugging catheter, the cross section of the conveying cavity is circular, the axis of the conveying cavity deviates from the axis of the multi-cavity tube, the first cavity is distributed annularly around the conveying cavity, and the second cavity is arranged on one side, with the largest distance, of the conveying cavity and the first cavity and is positioned between the first cavity and the conveying cavity.
Optionally, in the occlusion catheter, the occlusion catheter further includes an elastic structure for sealing the distal end of the multi-cavity body, the elastic structure has a passage through which the guide wire passes out from the distal end of the multi-cavity body, the passage is closed in a natural state, and is engaged with the guide wire by elastic deformation when the guide wire passes through.
Optionally, in the occlusion catheter, the multi-lumen tube comprises a first section and a second section connected to a distal end of the first section, wherein the first expandable element is disposed on the first section, the second expandable element is disposed on the second section, and the opening is located at a connection between the first section and the second section.
Optionally, in the occlusion catheter, an outer diameter of the second section is smaller than an outer diameter of the first section.
Optionally, in the occlusion catheter, a distal end of the first lumen is in communication with a lumen of the first expandable element; or,
the distal end of the first chamber extends to the second section after passing through the first expandable member, and at least the portion of the first chamber that passes out of the distal end of the first expandable member is filled with a stiffener.
Optionally, in the plugging catheter, the cross section of the conveying cavity is circular, the axis of the conveying cavity deviates from the axis of the multi-cavity tube, and the liquid passing cavity is on one side with the largest distance between the conveying cavity and the outer side wall of the multi-cavity tube.
The present invention also provides a medical system comprising:
the occlusion catheter of any of the above claims, and,
and the guide wire is used for penetrating out of the distal end of the blocking catheter along the conveying cavity so as to guide the blocking catheter to reach target tissues.
Optionally, in the medical system, the medical system further includes:
an instrument for penetrating from the delivery lumen and out of the opening for performing a medical procedure on the target tissue.
In summary, the occlusion catheter and the medical system provided by the invention comprise: a multi-lumen tube, a first expandable member, and a second expandable member; the first expandable element and the second expandable element are disposed at a set distance apart along an axial direction of the multi-lumen tube; the multi-cavity tube is provided with a liquid passing cavity and a conveying cavity; the access lumen extending distally from the proximal end of the multi-lumen tube and communicating with the lumens of the first and second expandable elements; the delivery lumen is disposed therethrough along an axial direction of the multi-lumen tube from a proximal end of the multi-lumen tube to a location between the first expandable element and the second expandable element, the multi-lumen tube having an opening in a sidewall between the first expandable element and the second expandable element, the opening in communication with the delivery lumen for passage of an instrument therethrough.
The plugging catheter and the medical instrument provided by the invention have at least the following advantages:
1. in the operation process, the common carotid artery and the external carotid artery are blocked by the blocking catheter for real-time protection, so that thrombus in the internal carotid artery can be better prevented from escaping.
2. The guide wire can be threaded out from the side wall between the two expansion elements, which is beneficial for positioning the two expansion elements on the bifurcated vessel.
3. The distal end is equipped with elastic construction, can prevent again when passing the seal wire that the blood flow from getting into the shutoff region through the distal end mouth, has guaranteed the shutoff effect.
4. The far end is provided with the reinforcing ribs, so that the connection strength and the pushing performance are improved.
Drawings
FIG. 1 is a partial cross-sectional view of a carotid artery;
FIG. 2 is a schematic diagram showing the working state of the occlusion catheter in carotid artery according to the embodiment of the invention;
FIG. 3 is a schematic view of the overall structure of a plugging catheter according to an embodiment of the present invention;
FIG. 4 is a schematic view of a local structure of a distal end of an occlusion catheter according to an embodiment of the present invention;
FIGS. 5 and 6 are schematic views of the elastic structure in a closed state and an open state, respectively, according to an embodiment of the present invention;
FIG. 7 is a schematic view of section A-A of the occlusion catheter of FIG. 3 in accordance with a first embodiment of the invention;
FIG. 8 is a schematic view of section b-b of the occlusion catheter of FIG. 3 in accordance with a first embodiment of the invention;
FIG. 9 is a schematic view of a section b-b of the occlusion catheter shown in FIG. 4 according to a first embodiment of the present invention;
FIG. 10 is a schematic view of a first chamber with a stiffener therein according to an embodiment of the present invention;
FIG. 11 is a schematic view in section A-A shown in FIG. 8;
FIG. 12 is a schematic view of section A-A of the occlusion catheter of FIG. 3 in accordance with a second embodiment of the invention;
FIG. 13 is a schematic view of section b-b of the occlusion catheter of FIG. 3 in accordance with a second embodiment of the invention;
FIG. 14 is a schematic view of a cross-section A-A of the occlusion catheter shown in FIG. 3 according to a second embodiment of the invention;
FIG. 15 is a schematic view of a section b-b of the occlusion catheter shown in FIG. 3 according to a second embodiment of the invention;
wherein, each reference sign is explained as follows:
11-a multi-lumen tube; 12-a first expandable member; 13-a second expandable member; 14-elastic structure; 15-connecting means;
100-a first chamber; 200-a second chamber; 300-a delivery lumen; 400-opening; 500-pass channels; 600-reinforcing ribs;
111-first section; 112-second section.
Detailed Description
The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments. It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.
In this document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to an end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to an end that first enters the patient.
[ embodiment one ]
Referring to fig. 2 in combination with fig. 3, an embodiment of the present invention provides an occlusion catheter, the occlusion catheter comprising: a multi-lumen tube 11, a first inflatable element 12 and a second inflatable element 13.
The first and second inflatable elements 12, 13 are arranged at set distance intervals in the extension direction of the multi-lumen tube 11 in the multi-lumen tube 11.
The multi-lumen tube 11 has a lumen extending distally from the proximal end of the multi-lumen tube 11 and communicating with the lumens of the first and second inflatable elements 12, 13; in order to facilitate the passage of filling fluid to the first and second inflatable elements 12, 13, respectively, to control the expansion of the first and second inflatable elements 12, 13, respectively, it is preferred that the fluid passage comprises a first chamber 100 and a second chamber 200, see fig. 7-9, the first and second chambers 100, 200 being in communication with the inner lumen of the first and second inflatable elements 12, 13, respectively.
The multi-lumen tube 11 also has a delivery lumen 300, the delivery lumen 300 being disposed therethrough in the axial direction of the multi-lumen tube 11 from the proximal end of the multi-lumen tube 11 to a location between the first and second expandable elements 12, 13.
In addition, referring to fig. 4, the multi-lumen tube 11 has an opening 400 in the sidewall between the first and second expandable members 12, 13, the opening 400 being in communication with the delivery lumen 300 for the passage of an instrument penetrating from the delivery lumen 300.
Before the operation starts, the occlusion catheter provided in the embodiment of the present invention reaches the target position through the sheath, and then is guided by the guide wire, and before the operation starts, the first inflatable element 12 is filled with filling liquid through the first chamber 100, so that the first inflatable element 12 occludes the external carotid artery, the second inflatable element 13 is filled with filling liquid through the second chamber 200, so that the second inflatable element 13 occludes the common carotid artery, and after the external carotid artery and the common carotid artery are occluded by the first inflatable element 12 and the second inflatable element respectively, blood cannot flow from bottom to top in the internal carotid artery, so that thrombus cannot escape to a far-end finer blood vessel during the subsequent operation (for example, stent placement). And because the operation process has short operation time compared with CEA operation, serious damage to cerebral vessels caused by long-time cerebral blood supply insufficiency can be avoided.
The occlusion catheter according to the embodiment of the present invention is mainly used for introducing filling liquid into the first chamber 100 and the second chamber 200 for expanding the second expandable member 13 of the first expandable member 12, respectively. The delivery lumen 300 is a multi-functional lumen for threading a guidewire on the one hand so as to be able to be in place under the guidance of the guidewire, and for threading an instrument after withdrawal of the guidewire on the other hand, the instrument being threaded out of the delivery lumen 300 through the opening 400 and into the focal region of the internal carotid artery for surgical procedures. In addition, the delivery lumen 300 may be further used as a reflux lumen, specifically, a reflux line may be externally connected to the distal end of the delivery lumen 300, one end of the reflux line is connected to the distal end of the delivery lumen 300, and the other end is connected to a vein (such as a femoral vein, a jugular vein, etc.), so that the pressure difference between the artery and the vein can be utilized, so that the stagnant blood in the focal region of the carotid artery can flow through the opening 400, the delivery lumen 300, the reflux line, and finally flow to the vein in sequence, a filtering device may be disposed in the reflux line, and thrombus falling off from the focal region during the blood flowing to the vein can be recovered by the filtering device, thereby avoiding thrombus in the blood flowing to the vein. In addition, different sections of the delivery lumen 300 may serve different functions, for example, with the distal lumen of the opening 400 serving as a quick-change port for passage of a guidewire, and the proximal lumen of the opening 400 serving as a lumen for delivery of a medical device through a stent, aspiration catheter, etc.
The first inflatable element 12 and the second inflatable element 13 may be a single-layer or double-layer balloon, and the material may be selected from silica gel, or polymer materials such as polyesters, polyurethanes, thermoplastic elastomers, polyethylene, polyolefin copolymers, or a combination of a plurality of these materials, which will not be described herein.
Referring to fig. 3, in this embodiment, the multi-lumen tube 11 includes a first section 111 and a second section 112 connected to a distal end of the first section 111, and the opening 400 for passing the instrument is provided at a connection point between the first section 111 and the second section 112. The first expandable element 12 is disposed on the first section 111, the second expandable element 13 is disposed on the second section 112, and for omnibearing plugging to ensure a plugging effect, the first expandable element 12 may be sleeved on the first section 111, and the second expandable element 13 may be sleeved on the second section 112.
Preferably, the axis of the first section 111 and the axis of the second section 112 are disposed at an angle so that the second section 112 can pass into a distal branch (e.g., from the common carotid artery into the external carotid artery).
Further preferably, at least the first section 111 is a deformable section, and the first section 111 is configured to adjust an angle with the second section 112 by deformation.
In addition, the outer diameter of the second section 112 is preferably smaller than that of the first section 111, so that the second section 112 can be passed into a branch of a blood vessel with a smaller inner diameter on the one hand, and the second section 112 with a smaller outer diameter has a smaller rigidity than that of the first section 111 on the other hand, so that the shape of the second section is easier to change to adjust the offset angle and direction of the second section with respect to the first section 111.
Preferably, referring to fig. 4, the occlusion catheter further comprises an elastic structure 14, the elastic structure 14 is used for sealing the distal end of the multi-lumen tube 11, the elastic structure 14 has a passage 500 for a guide wire to pass out from the distal end of the multi-lumen tube, and the passage 500 is closed in a natural state and is opened by elastic deformation when the guide wire passes through and is matched with the guide wire. The provision of the elastic structure 14 prevents blood flow from entering the occlusion region through the distal port and affecting the bifurcated vessel during the procedure.
In this embodiment, alternatively, the elastic structure 14 may comprise an elastic tube for passing the guide wire and an elastic ring, wherein the elastic ring is sleeved on the elastic tube after the guide wire is inserted, and the elastic ring presses a partial area of the elastic tube, so that the elastic tube and the guide wire are matched, and after the guide wire is withdrawn from the proximal end, the elastic ring is retracted, so that a corresponding area of the elastic tube is closed, and thus the distal end of the multi-cavity tube 11 can be sealed.
In the alternative embodiments described above, there may be a risk that the elastic ring will fall off during use. Therefore, in this embodiment, as shown in fig. 5 and 6, it is preferable that the elastic structure 14 is an integrally formed elastic body, at least part of the elastic body is in a shape of a flat mouth, and has a through passage 500, the through passage 500 is closed between the guide wire inserts, after the elastic body is pressed and deformed elastically in the width direction, the through passage 500 is opened for the guide wire to pass through, after the guide wire passes through, the pressing is stopped, at this time, the inner diameter of the elastic body is adapted to the outer diameter of the guide wire, and the inner diameter of the elastic body and the outer diameter of the guide wire are matched, so that the distal end of the multi-cavity tube 11 can be sealed, blood is prevented from entering the multi-cavity tube 11 from the distal end of the multi-cavity tube 11, and after the guide wire is withdrawn from the proximal end, the elastic structure 14 is restored to the closed state, and thus the sealing of the distal end of the multi-cavity tube 11 can be maintained.
In this embodiment, referring to fig. 7 and 8, the cross section of the delivery lumen 300 is circular, and the axis of the delivery lumen 300 is offset from the axis of the multi-lumen tube 11, so that one side of the delivery lumen 300 is relatively farther from the outer sidewall of the multi-lumen tube 11 and the other side is relatively closer to the outer sidewall of the multi-lumen tube 11 in the direction of the eccentricity of the delivery lumen 300. In order to facilitate the arrangement of the first and second chambers 100, 200, the first and second chambers 100, 200 are arranged on the side of the delivery lumen 300 having the greatest distance from the outer side wall of the multi-lumen tube 11. When the first chamber 100, the second chamber 200, and the delivery chamber 300 are arranged in this way, the inner cavity of the delivery chamber 300 can be maximized without changing the outer diameter, so that the smoothness of the delivery chamber 300 as a reflow chamber can be better ensured. In other embodiments, the access lumen is a single lumen, the access lumen being located on the side of the delivery lumen 300 having the greatest distance from the outer sidewall of the multi-lumen tube 11.
The cross-sections of the first chamber 100 and the second chamber 200 may be circular, but the application is not limited thereto, and in other embodiments, the cross-sections of the first chamber 100 and the second chamber 200 may be square, triangular, oval, etc. However, in view of the difficulty in practical engineering, it is preferable that the cross sections of the first chamber 100 and the second chamber 200 are circular, and in view of the flow rate requirement of the filling liquid, the first chamber 100 and the second chamber 200 are sequentially disposed in the circumferential direction.
In this embodiment, the distal end of the second lumen 200 extends to the second segment 112 where it communicates with the lumen of the second expandable member 13; for the first chamber 100, optionally, the distal end of the first chamber 100 may extend to not more than the first section 111 to communicate with the inner cavity of the first expandable member 12, or, referring to fig. 9, the distal end of the first chamber 100 may extend to the second section 112 after passing through the first expandable member 12, for example, may extend to the most distal end of the second section 112, and the first chamber 100 may be configured with a variable diameter having a distal diameter smaller than a proximal diameter to match the outer diameters of the first section 111 and the second section 112.
Referring to fig. 10 and 11, preferably, at least the portion of the first chamber 100 that extends beyond the first inflatable element 12 is filled with a stiffener 600. The reinforcing rib 600 may improve the connection strength at the connection between the first section 111 and the second section 112, so as to ensure the pushing performance in the pushing process. The proximal end of the reinforcing rib 600 may extend into the first section 111, the distal end may extend to the most distal end of the second section 112, the reinforcing rib 600 may also be designed with a variable diameter, the outer diameter gradually decreases from the proximal end to the distal end, the hardness gradually decreases from the proximal end to the distal end, and the material may be a developing wire, or a polymer wire wrapping developing metal or common metal, so as to facilitate adhesion with the polymer on the inner surface of the first chamber 100. In addition, in order to facilitate the installation of the reinforcing rib 600, the first section 111 and the second section 112 may be formed separately, and then fixedly connected by welding or the like after the installation of the reinforcing rib 600 is completed.
Preferably, from the first section 111 to the second section 112, the second chamber 200 and the delivery chamber 300 are designed with a variable diameter, i.e. the cross-sectional shape is not changed, and only the dimensions are scaled down to accommodate the dimensions of the first section 111 and the second section 112. The design is beneficial to reducing the splicing difficulty of the first section 111 and the second section 112. If the first chamber 100 extends to the second section 112, the first chamber 100 is also of a variable diameter design.
The occlusion catheter provided in the embodiment of the present invention may further include a connection device 15, where the connection device 15 is connected to the proximal end of the multi-lumen tube 11, the connection device 15 has an inner cavity disposed along an axial direction, and the connection device 15 has a plurality of connectors communicating with the inner cavity, and the plurality of connectors are respectively used for externally connecting filling liquid filling and recovering equipment, and connecting a return tube, etc.
The embodiment of the invention also provides a medical system, which comprises: the occlusion catheter and guide wire provided in this embodiment are used to pass out of the distal end of the occlusion catheter along the delivery lumen 300 to guide the occlusion catheter to the target tissue.
The medical system may also include an instrument for passing into the delivery lumen 300 and out of the opening 400 for performing a medical procedure on the target tissue. The type of the apparatus is not particularly limited, and for example, the apparatus may be a therapeutic apparatus for treating carotid artery or intracranial vascular diseases, an apparatus for placing a vascular stent, or the like.
Optionally, the medical system may further comprise a sheath tube, wherein the sheath tube is used for sleeving the occlusion catheter and guiding the occlusion catheter to reach a target position.
[ example two ]
The second embodiment is similar to the embodiment, and only the differences are described below.
In this embodiment, referring to fig. 12 and 13, the cross section of the conveying chamber 300 is circular, the axis of the conveying chamber 300 is offset from the axis of the multi-lumen tube 11, the first chambers 100 are annularly distributed around the conveying chamber 300 and coaxially arranged with the multi-lumen tube 11, and the second chambers 200 are disposed on the side of the conveying chamber 300 having the greatest distance from the second chambers 200 and between the first chambers 100 and the conveying chamber 300. The shape of the second chamber 200 is not particularly limited in this embodiment, and the cross section of the second chamber 200 may be circular, square, oblong (oval), etc. When the cross section of the second lumen 200 is oblong as shown in fig. 14 and 15, the outer diameter of the multilumen tubing 11 can be minimized with the lumen volume unchanged.
Compared with the first embodiment, the size of the multi-cavity tube in the second embodiment is easier to control, and the processing technology is relatively simpler. In addition, in this embodiment, the thickness of the wall of the multi-lumen tube 11 is thicker, so that the supporting performance is better in the case of equal outer diameters, and in this embodiment, the multi-lumen tube 11 has an inner-outer double-layer structure, so that more material combination modes can be used to adjust the excessive hardness change.
In this embodiment, the second chamber 200 and/or the delivery chamber 300 may be deformed by the second section 112, for example, in a case where the distal end of the first chamber 100 does not extend to the second section 112, the cross section of the second chamber 200 in the second section 112 is not reduced by a certain ratio with respect to the cross section of the first section 111, but may be changed in shape, for example, from an oblong shape to an annular shape distributed around the delivery chamber 300, so that the flow rate of the filling liquid flowing through the second chamber 200 may be increased.
The occlusion catheter provided in the above two embodiments may be selected according to different use cases. For example, the common carotid artery and the external carotid artery are accessed in a way of penetrating the path from the carotid artery, and the whole blood vessel is straight and the path is short from the puncture point to the target blood vessel, so that the plugging catheter provided by the first embodiment can be adopted to enlarge the main cavity as much as possible; if the femoral artery is penetrated into the target blood vessel, the whole path is longer, and a more tortuous blood vessel possibly exists, so that the plugging catheter provided by the second embodiment can be adopted to adjust the hardness supportability and the flexibility of different sections.
In addition, in both the above embodiments, the multi-lumen tube may include an inner tube, and the inner tube may be made of Polytetrafluoroethylene (PTFE) or the like, so as to ensure smooth sliding with other devices. In order to further ensure the supportability and the flexibility, a coiling spring or a braiding structure made of stainless steel, nickel titanium or other materials can be added between the inner layer and the multi-cavity outer layer.
In summary, the occlusion catheter and the medical system provided by the invention comprise: a multi-lumen tube, a first expandable member, and a second expandable member; the first expandable element and the second expandable element are disposed at a set distance apart along an axial direction of the multi-lumen tube; the multi-cavity tube is provided with a liquid passing cavity and a conveying cavity; the access lumen extending distally from the proximal end of the multi-lumen tube and communicating with the lumens of the first and second expandable elements; the delivery lumen is disposed therethrough along an axial direction of the multi-lumen tube from a proximal end of the multi-lumen tube to a location between the first expandable element and the second expandable element, the multi-lumen tube having an opening in a sidewall between the first expandable element and the second expandable element, the opening in communication with the delivery lumen for passage of an instrument therethrough. In the CAS operation, the common carotid artery and the external carotid artery are blocked by the blocking catheter for real-time protection, so that thrombus in the internal carotid artery can be better prevented from escaping.
In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the difference from other embodiments, so that the same similar parts of each embodiment are referred to each other.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims (10)

1. A occlusion catheter, the occlusion catheter comprising: a multi-lumen tube, a first expandable member, and a second expandable member;
the first expandable element and the second expandable element are disposed at a set distance interval to the multi-lumen tube along the extension direction of the multi-lumen tube; the multi-cavity tube is provided with a liquid passing cavity and a conveying cavity; the access lumen extending distally from the proximal end of the multi-lumen tube and communicating with the lumens of the first and second expandable elements; the delivery lumen is disposed therethrough along an axial direction of the multi-lumen tube from a proximal end of the multi-lumen tube to a location between the first expandable element and the second expandable element; the multi-lumen tube has an opening in a sidewall between the first and second expandable members, the opening communicating with the delivery lumen for the passage of an instrument passed through the delivery lumen.
2. The occlusion catheter of claim 1, wherein the access lumen comprises a first chamber and a second chamber, the first chamber and the second chamber in communication with the inner lumen of the first expandable member and the second expandable member, respectively.
3. The occlusion catheter of claim 2, wherein the delivery lumen has a circular cross-section and an axis of the delivery lumen is offset from an axis of the multi-lumen tube, the first lumen is annularly disposed about the delivery lumen, and the second lumen is disposed on a side of the delivery lumen having a greatest distance from the first lumen and between the first lumen and the delivery lumen.
4. The occlusion catheter of claim 1, further comprising an elastic structure for sealing the distal end of the multi-lumen, the elastic structure having a passway through which a guidewire passes from the distal end of the multi-lumen, the passway through being closed in a natural state and mating with the guidewire by elastic deformation as the guidewire passes through.
5. The occlusion catheter of claim 1, wherein the multi-lumen tube comprises a first section and a second section connected to a distal end of the first section, wherein the first expandable element is disposed on the first section and the second expandable element is disposed on the second section, and wherein the opening is located at a connection of the first section and the second section.
6. The occlusion catheter of claim 5, wherein an outer diameter of the second section is smaller than an outer diameter of the first section.
7. The occlusion catheter of claim 5, wherein a distal end of the first lumen is in communication with a lumen of the first expandable element; or,
the distal end of the first chamber extends to the second section after passing through the first expandable member, and at least the portion of the first chamber that passes out of the distal end of the first expandable member is filled with a stiffener.
8. The occlusion catheter of claim 1, wherein the delivery lumen is circular in cross-section and the axis of the delivery lumen is offset from the axis of the multi-lumen tube, the access lumen being on a side of the delivery lumen having a greatest distance from an outer sidewall of the multi-lumen tube.
9. A medical system, the medical system comprising:
the occlusion catheter of any of claim 1-8, wherein the occlusion catheter is configured to receive a catheter,
and the guide wire is used for penetrating out of the distal end of the blocking catheter along the conveying cavity so as to guide the blocking catheter to reach target tissues.
10. The medical system of claim 9, wherein the medical system further comprises:
an instrument for penetrating from the delivery lumen and out of the opening for performing a medical procedure on the target tissue.
CN202211194223.7A 2022-09-28 2022-09-28 Occlusion catheter and medical system Pending CN117815518A (en)

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PCT/CN2023/119636 WO2024067241A1 (en) 2022-09-28 2023-09-19 Occlusion catheter and medical system

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IT1304770B1 (en) * 1998-12-03 2001-03-29 Gioacchino Coppi ENDOVASCULAR SYSTEM FOR THE TREATMENT OF ECATETERE CAROTID STENOSIS FOR SUCH SYSTEM.
WO2014113257A2 (en) * 2013-01-15 2014-07-24 A.V. Medical Technologies, Ltd. Infusion catheter with guidewire valving
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WO2016044647A2 (en) * 2014-09-17 2016-03-24 Metactive Medical, Inc. Expandable body device and method of use
CN210750821U (en) * 2019-05-07 2020-06-16 深圳市业聚实业有限公司 Guide extension catheter for fixing guide wire
CN113995945A (en) * 2021-12-10 2022-02-01 深圳北芯生命科技股份有限公司 Extension catheter
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CN219307683U (en) * 2022-09-28 2023-07-07 神途医疗科技(上海)有限公司 Occlusion catheter and medical system

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