CN113827312B - Delivery system for pulmonary artery embolectomy - Google Patents

Delivery system for pulmonary artery embolectomy Download PDF

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Publication number
CN113827312B
CN113827312B CN202111103019.5A CN202111103019A CN113827312B CN 113827312 B CN113827312 B CN 113827312B CN 202111103019 A CN202111103019 A CN 202111103019A CN 113827312 B CN113827312 B CN 113827312B
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Prior art keywords
tube
outer sheath
assembly
pulmonary artery
thrombus
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CN202111103019.5A
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CN113827312A (en
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周欣
姜程文
梁玉晨
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Chenxing Nantong Medical Instrument Co ltd
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Chenxing Nantong Medical Instrument Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • 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
    • 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
    • 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
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • 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
    • A61M25/0102Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • 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
    • A61M25/0194Tunnelling catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001Angioplasty, e.g. PCTA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • 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
    • A61M25/0194Tunnelling catheters
    • A61M2025/0197Tunnelling catheters for creating an artificial passage within the body, e.g. in order to go around occlusions
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
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  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses a conveying system for pulmonary artery embolectomy, which comprises an outer sheath tube and a sheath tube connecting piece. The sheath tube connecting piece is provided with a tee joint, an elastic tube and an extrusion tube, the distal end of the inner half part of the extrusion tube is abutted against the proximal end of the elastic tube, and the outer half part of the extrusion tube is movably locked outside the proximal section of the tee joint; the outer sheath tube can be sequentially arranged in the tee joint, the elastic tube and the extrusion tube in a penetrating way, and the outer part of the far section of the extrusion tube is locked outside the near section of the tee joint so as to extrude the elastic tube to deform, thereby further extruding the outer sheath tube to seal the outer sheath tube. The pulmonary artery thrombus taking device of the invention enters the vicinity of the thrombus position in the blood vessel in an interventional way, establishes a catheter channel, assists in completing the taking out of pulmonary artery thrombus, is beneficial to reducing the injury of large-area thrombus to human bodies, reducing symptoms such as dyspnea, chest pain and the like, relieving heart failure, simplifying products and optimizing operation.

Description

Delivery system for pulmonary artery embolectomy
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a conveying system for a pulmonary artery thrombus remover.
Background
Pulmonary embolism (Pulmonary Embolism, PE) is a clinical pathophysiological syndrome of pulmonary circulatory disturbance caused by an exfoliated thrombus or other substance blocking a pulmonary artery or its branches. Pulmonary embolism is also often in the form of complications, as various embolic sloughing off of the systemic circulation may cause pulmonary embolism. Emboli are usually derived from deep veins of the lower extremities and pelvis, causing embolism by circulation to the pulmonary artery. To date 2019, global new coronary epidemic has been abused, indirectly pushing the incidence of pulmonary embolism to climax again. Professor Stefan Kluge, major in intensive care clinics, indicated that covd-19 has been observed in daily clinical practice to cause thrombosis and pulmonary embolism in patients in many cases; researchers at the university of Styrasburgh hospital, when examining 106 severe patients with Covid-19, found that the proportion of acute pulmonary angiogenesis embolisms was as high as 30%, much higher than those with severe patients without Covid-19 infection (1.3%).
The traditional methods for treating pulmonary embolism at present comprise drug treatment, thrombolysis treatment and traditional operation treatment. The traditional open surgery has the defects of large bleeding amount, large traumata and higher clinical indication requirement on patients. The minimally invasive interventional therapy can overcome the defects of the drug therapy, thrombolytic therapy and traditional surgical treatment methods.
In the prior art, the design of the conveying system for the thrombus taking device is too complex, and the process cost and the production cost are both higher, so that the technical popularization is not facilitated. For this reason, improvements are needed to overcome the shortcomings in practical applications.
Disclosure of Invention
The invention aims at solving the technical problem that the design of a conveying system for a pulmonary artery thrombus taking device in the prior art is too complex, and aims to provide a novel conveying system for the pulmonary artery thrombus taking device.
The pulmonary artery embolectomy delivery system of the present invention includes:
an outer sheath tube assembly, the outer sheath tube assembly having: an outer sheath and sheath connector in communication with the outer sheath;
wherein the sheath connector has:
a tee, the distal end of the tee being in communication with the proximal end of the outer sheath;
an elastic tube, the distal end of which is propped against the proximal end of the tee joint and is communicated with the tee joint; the elastic tube is a hollow tubular body with two open ends and a middle part contracted towards the middle part along the radial direction;
a squeeze tube, the distal end of the inner half of the squeeze tube being abutted against and in communication with the proximal end of the elastic tube, the outer half of the squeeze tube being movably locked to the exterior of the proximal section of the tee;
the outer part of the distal section of the extrusion tube is locked on the outer part of the proximal section of the tee joint so as to extrude the elastic tube to deform, thereby further extruding the outer sheath tube so as to seal the outer sheath tube.
In a preferred embodiment of the present invention, the extruded tube has:
a transition inner tube which is an inner half part of the extrusion tube, wherein the distal end of the transition inner tube is propped against the proximal end of the elastic tube and is communicated with the elastic tube;
the extrusion outer tube is an outer half part of the extrusion tube, is sleeved outside the transition inner tube and is fixedly connected with the transition inner tube, and is movably locked outside the proximal section of the tee joint.
The transition inner tube does not extend beyond the distal end of the extruded outer tube of the sheath connector to facilitate penetration of other components into and/or out of the sheath connector.
In a preferred embodiment of the present invention, the inner surface of the extruded outer tube has at least one internal thread, and the corresponding position outside the proximal section of the tee has at least one external thread, and the internal thread of the extruded outer tube is screwed on the external thread of the tee, so that the elastic tube can be extruded to deform to form an end seal. More preferably, the inner surface of the extrusion outer tube is provided with two internal threads, the corresponding position outside the proximal section of the tee joint is provided with two external threads, and the two internal threads of the extrusion outer tube are screwed on the two external threads of the tee joint, so that the elastic tube can be extruded to deform to form an end seal.
In a preferred embodiment of the present invention, there are two gaskets respectively abutting against two ends of the elastic tube, by means of which the distal end of the elastic tube abuts against the proximal end of the tee, and the proximal end of the elastic tube abuts against the inner half of the extrusion tube.
In a preferred embodiment of the present invention, the outer surface of the elastic tube is concave along the axial direction, and the elastic tube is made of rubber and is extruded by the extrusion tube to seal the outer sheath tube.
In a preferred embodiment of the present invention, the pulmonary artery embolectomy delivery system further includes a dilator assembly disposed within the outer sheath of the outer sheath assembly for guiding the outer sheath.
The extrusion pipe is provided with a connecting ring, the transition inner pipe is connected in the connecting ring, and the extrusion outer pipe is connected outside the connecting ring. The transition inner tube, the connecting ring and the extrusion outer tube are integrally formed. The transition inner tube is also internally provided with a raised ring.
In a preferred embodiment of the present invention,
the dilator assembly has:
an expansion tube which can be arranged in the outer sheath tube in a penetrating way;
the expansion head end is hollow and cone-like and is used for guiding the outer sheath tube, is connected to the distal end of the expansion tube and can be exposed out of the distal end of the outer sheath tube; the expansion head end drives the outer sheath tube assembly to enter the body along a guide wire, and guides the outer sheath tube assembly to establish an outer sheath tube channel;
the expansion handle is connected to the proximal end of the expansion tube, can be exposed out of the proximal end of the outer sheath tube and is used for operating the expander assembly to conduct guiding action; the outer periphery of the expansion handle is provided with at least one booster, and the booster extends outwards along the outer periphery of the expansion handle.
The pulmonary artery embolectomy delivery system further comprises a guide wire, and the expander assembly drives the outer sheath tube assembly to enter the body along the guide wire and guides the outer sheath tube assembly to establish a sheath tube channel.
In a preferred embodiment of the present invention, the pulmonary artery embolectomy delivery system further includes a negative pressure aspirator in communication with the extruded tube of the sheath connector for aspirating thrombus under negative pressure.
In a preferred embodiment of the present invention, the negative pressure aspirator has:
the negative pressure cylinder body is communicated with the third end of the tee joint, and a clamping column is arranged on the inner wall, close to the cylinder opening, of the negative pressure cylinder body;
the piston plunger is inserted in the negative pressure cylinder in a sealing mode, a plurality of buckles are arranged on the piston plunger at intervals, and the buckles can be matched with the clamping columns to form a clamping structure. The locking structure is formed so as to lock and position at the set volume scale.
In a preferred embodiment of the present invention, the distal end of the negative pressure cylinder may be indirectly connected to the third end of the tee by means of a tee extension.
The negative pressure aspirator may be in communication through a negative pressure aspirator connection, such as a three-way extension tube, and the outer sheath tube assembly to aspirate thrombus in the pulmonary artery.
In a preferred embodiment of the present invention, the pulmonary artery embolectomy delivery system further includes an embolectomy assembly disposed within the outer sheath of the outer sheath assembly for removing thrombus.
In a preferred embodiment of the present invention, the thrombolysis device comprises:
the inner tube is movably arranged in the outer sheath tube of the outer sheath tube assembly in a penetrating way; the inner tube can pass through the outer sheath tube assembly to reach a target position of pulmonary thrombosis, and the sheath tube connecting piece can extrude the elastic tube through the extrusion outer tube which is connected through threads so as to lock the inner tube;
a hemostatic Y-valve in communication with the proximal end of the inner tube and adapted to be exposed at the proximal end of the outer sheath assembly;
the push-pull rod can sequentially penetrate through the inner tube and the hemostatic Y valve, and passes through one inlet end of the hemostatic Y valve, and the proximal end of the push-pull rod can be exposed out of the hemostatic Y valve;
the other inlet end of the hemostatic Y valve is connected with a standard component II through a luer connector, and the hemostatic Y valve can be sealed by a luer cap and can also be used as a spare connector for connecting other products;
the proximal end of the thrombus taking device is fixed at the distal end of the push-pull rod, and the thrombus taking device can be driven by the push-pull rod to be pressed and held in the inner tube so as to convey the thrombus taking device to a target position for taking thrombus near the distal end of the outer sheath assembly.
The thrombus taking device comprises a plurality of thrombus accommodating cavities which are communicated with one another, wherein the thrombus accommodating cavities are of a woven reticular structure, and the thrombus accommodating cavities are made of self-expanding materials.
The invention has the positive progress effects that: the pulmonary artery thrombus taking device of the invention enters the vicinity of the thrombus position in the blood vessel in an interventional way, establishes a catheter channel, assists in completing the taking out of pulmonary artery thrombus, is beneficial to reducing the injury of large-area thrombus to human bodies, reducing symptoms such as dyspnea, chest pain and the like, relieving heart failure, simplifying products and optimizing operation. The outer sheath tube component can be used as a thrombus outflow channel for guiding thrombus out of the body when the negative pressure aspirator sucks thrombus, and can also be used as a catheter channel of the thrombus taking component for assisting the thrombus taking component to quickly reach the front end of the thrombus for thrombus taking operation under the condition of not damaging blood vessels; the invention has simple operation and high safety, and improves the success rate of the operation.
The sheath tube connecting piece can be well matched with other components such as the expander component, the negative pressure aspirator or the thrombus taking component, and can immediately lock or unlock the expander component, the negative pressure aspirator or the thrombus taking component inside by simply screwing or unscrewing the extrusion tube on the sheath tube connecting piece, so that the structure is simple and the operation is convenient.
The conveying catheter system device is simple to prepare, light in weight and easy to popularize, and has small harm to patients in an interventional mode, so that the adverse symptoms of serious patients suffering from large-area embolism can be effectively relieved. .
Drawings
Fig. 1 is a schematic view of an assembled structure of an outer sheath tube assembly 20 of the present invention;
FIG. 2 is a schematic view of an angle structure of the sheath connector 22 according to the present invention;
FIG. 3 is a schematic view of another angular configuration of the sheath connector 22 of the present invention;
FIG. 4 is a schematic diagram showing an assembled structure of an elastic tube 222, an extruded tube 223 and two gaskets 224 according to the present invention;
FIG. 5 is a schematic view of the assembled construction of the dilator assembly 30 of the present invention;
FIG. 6 is a schematic drawing showing the structure of the negative pressure suction apparatus 40 in a pulled-out state according to the present invention;
fig. 7 is a schematic view showing the pushing state of the negative pressure suction apparatus 40 according to the present invention;
FIG. 8 is a schematic diagram of an assembled structure of a thrombolytic device 50 according to the present invention;
FIG. 9 is a schematic illustration of the process configuration of the sheath tube assembly 20 and dilator assembly 30 of the present invention in accessing a vascular target site;
fig. 10 is a schematic view showing a process structure of the thrombus grasping process in the channel formed by the outer sheath tube assembly 20 by the thrombus grasping assembly 50 of the present invention.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention.
In the present invention, "distal", "proximal", "distal" and "proximal" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "distal" refers to an end or section of a surgical procedure that is distal to an operator, and "proximal" refers to an end or section of a surgical procedure that is proximal to an operator. Axial, refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.
As shown in fig. 1 to 8, the pulmonary artery embolectomy delivery system of the present invention includes: a guidewire (not shown), an outer sheath tube assembly 20, a dilator assembly 30, a negative pressure aspirator 40, and a thrombolysis assembly 50.
As further shown in fig. 1 to 4, the outer sheath tube assembly 20 has an outer sheath tube 21 and a sheath tube connecting member 22 connected to the outer sheath tube 21, wherein the proximal end of the outer sheath tube 21 is in a flare design, and is combined with the sheath tube connecting member 22 by means of gluing and screw compaction. The sheath connector 22 has a tee 221, an elastic tube 222, a squeeze tube 223, and two shims 224. Tee 221 is, for example, a T-shaped nonstandard connector, with a proximal end in communication with a proximal end of outer sheath 21. The distal end of the elastic tube 222 abuts against the proximal end of the tee 221 by means of a gasket 224 and is communicated with the tee 221; the elastic tube 222 is a hollow tubular body with two open ends and a central part contracted toward the central part along the radial direction, namely, the outer surface is concave along the axial direction, the elastic tube is made of rubber, and is extruded by the extrusion tube 223 to seal the outer sheath tube 21. The inner half of the extrusion tube 223, i.e., the distal end of the transition inner tube 2231, abuts the proximal end of the elastic tube 222 via a gasket 224 and communicates with the elastic tube 222 to reduce wear on both ends of the extrusion tube 223 during the rotational extrusion of the three-way and extrusion tube 223. The outer half part of the extrusion tube 223, namely the extrusion outer tube 2232, is sleeved outside the transition inner tube 2231 and fixedly connected with the transition inner tube 2231, and is movably locked outside the proximal section of the tee joint 221; the transition inner tube 2231 does not extend beyond the distal end of the extruded outer tube 2232 of the sheath connector 22 to facilitate penetration of other components into and/or out of the sheath connector 22. The extrusion tube 223 has a connection ring 2233, a transition inner tube 2231 is connected to the ring of the connection ring 2233, and an extrusion outer tube 2232 is connected to the outside of the connection ring 2233. The transition inner tube 2231, the connecting ring 2233, and the extruded outer tube 2232 are integrally formed. Also within the transition inner tube 2231 is a raised collar 2231a. The sheath tube connecting piece 22 is formed by combining one or more of PP, silica gel and high polymer materials, and the silica gel of the elastic tube 222 inside the extrusion tube 223 can achieve a completely sealed sealing effect by rotating the nut knob of the extrusion tube 223, so that the product design is simplified. The sheath 21 is made of one or more of PEBAX, PTFE, a polymer material, and stainless steel. The distal end of the sheath 21 is covered with a developing ring (not shown) which is mixed and fixed by one or more of PEBAX, PTFE, polymer material and stainless steel. The developing ring can be formed by mixing any one or more of nickel titanium wires, platinum iridium wires and platinum tungsten wires.
The inner surface of the squeeze outer tube 2232 has at least one internal thread 2232a, such as two internal threads 2232a, 2232b, and at least one external thread 221a, such as two external threads 221a, 221b, at a corresponding location on the exterior of the proximal section of the tee 221. The internal thread 2232a of the squeeze outer tube 2232 is screwed onto the external thread 221a of the tee 221, with the aid that the internal thread 2232b of the squeeze outer tube 2232 is screwed onto the external thread 221b of the tee 221, whereby the squeeze elastic tube 222 deforms to form an end seal. The extruded outer tube 2232, which is externally of the distal section of the extruded tube 223, is locked to the proximal section of the tee 221 so as to compress the elastic tube 222 to deform, thereby further sealing the proximal section of the tee 221 by the distal end of the elastic tube 222 and indirectly sealing the outer sheath 21.
As further shown in fig. 5, the dilator assembly 30 may be inserted into the outer sheath 21 through the sheath connector 22 of the outer sheath assembly 20, and the dilator assembly 30 is screwed and fixed by the extrusion tube of the sheath connector 22, for guiding the outer sheath 21, and the dilator assembly 30 is mixed and fixed by one or more of LDPE, HDPE, PP, PDFE, PA, carbon fiber, glass fiber and polymer materials. The dilator assembly 30 has a dilator tube 31, a dilator head end 32, and a dilator handle 33. The expansion tube 31 can be arranged in the outer sheath tube 21 in a penetrating way, and the core part of the expansion tube 31 is provided with a perforation, thereby having the functions of entering thrombus and passing through a guide wire. An expansion head end 32, which is hollow and cone-like in shape, is used for guiding the outer sheath 21, is connected to the distal end of the expansion tube 31, and can be exposed out of the distal end of the outer sheath 21; the expanding head end 32 drives the outer sheath tube assembly 20 into the body along the guide wire, and guides the outer sheath tube assembly 20 to establish an outer sheath tube channel; the expansion head end 32 is conical, has a smooth surface and no acute angle, and avoids scratching human blood vessels. A handle 33 for expansion connected to the proximal end of the expansion tube 32 and capable of being exposed to the proximal end of the outer sheath 21 for guiding the operation of the expander assembly 30; at least one assist member 331 is provided on the outer periphery of the expansion handle 33, and the assist member 331 extends outward along the outer periphery of the expansion handle 33.
As further shown in fig. 6-7, the negative pressure aspirator 40 may be in communication with the extruded tube of the sheath connector 22 for aspirating thrombus under negative pressure. The negative pressure suction device 40, like a syringe, has a negative pressure cylinder 41 and a piston plunger 42. The negative pressure cylinder 41 can be communicated with a third end 2211 of the tee joint 221, and the inner wall of the negative pressure cylinder 41 close to the cylinder mouth is provided with a clamping column 411. The piston plunger 42 is inserted in the negative pressure cylinder 41 in a piston sealing manner, a plurality of buckles 421 are arranged on the piston plunger 42 at intervals, and the buckles 421 can be matched with the clamping columns 411 to form a clamping structure. The locking structure is formed so as to lock and position at the set volume scale. The negative pressure cylinder 41 may be indirectly connected to the third port 2211 of the tee 221 by a negative pressure aspirator connecting member such as an extension tube 2212 made of TPU, so as to aspirate thrombus in the pulmonary artery. The TPU extension tube 2212 communicates with the third end 2211 of the tee 221. The tee 221 extension 2212 connects to the negative pressure aspirator 40. The negative pressure aspirator 40, in combination with the outer sheath tube assembly 20, can aspirate large and easily aspirated thrombus into the outer sheath 21, avoiding some of the sequence of subsequent thrombus removal device introductions. The tee 221, the outer sheath 21 and the extension tube may be combined by pressure bonding, cementing, or the like. The catch 421 can cooperate with the catch post 411 to form a snap fit structure that can be locked at any location along the length of the negative pressure cylinder 41 and can hold a vacuum for assisting in vacuum pumping of the internal plug.
As further shown in FIG. 8, a thrombus removal assembly 50 may be disposed within the outer sheath 21 of the outer sheath tube assembly 20 for thrombus disruption and grasping. The thrombolysis unit 50 has an inner tube 51, a hemostatic Y-valve 52, a push-pull rod 53 and a thrombolysis device 54. The inner tube 51 is movably arranged in the outer sheath tube 21 of the outer sheath tube assembly 20 in a penetrating manner; the inner tube 51 is mixed and fixed by one or more of PEBAX, PTFE, high polymer material and stainless steel, the inner tube 51 can pass through the outer sheath tube assembly 20 to reach the target position of pulmonary thrombosis, and the sheath connector 22 can press the elastic tube 222 through the screw-connected pressing outer tube 2232 so as to lock the inner tube 51. The hemostatic Y valve 52 is communicated with the proximal end of the inner tube 51 through an inner sheath connector (the inner sheath connector is made of one or more of PC and polymer materials), the hemostatic Y valve 52 can be exposed out of the proximal end of the outer sheath tube assembly 20, the tail end of the inner sheath connector is a standard luer, the hemostatic Y valve 52 can be connected through a luer connector, and the push-pull rod 53 can be pulled and positioned through a knob of the hemostatic Y valve 52. The push-pull rod 53 can sequentially penetrate through the inner tube 51 and the hemostatic Y-valve 52, the push-pull rod 53 penetrates through one inlet end of the hemostatic Y-valve 52, and the proximal end can be exposed out of the hemostatic Y-valve 52; the other inlet end of the hemostatic Y-valve 52 is connected to the standard two-way connector via a luer fitting, either closed with a luer cap or used as a back-up fitting for other products. The proximal end of the thrombus taking device 54 is fixed at the distal end of the push-pull rod 53, the thrombus taking device 54 comprises a plurality of thrombus accommodating cavities 541 which are mutually communicated, the thrombus accommodating cavities 541 are of a woven net structure, and the thrombus accommodating cavities 541 are made of self-expanding materials. The thrombus remover 54 may be held pressed within the inner tube 51 by a push-pull rod 53 to deliver the thrombus remover 54 to a target site for removal of thrombus near the distal end of the outer sheath 21 of the outer sheath assembly 20. The push-pull rod 53 of the thrombus remover 54 is controlled to be led in, led out and positioned by being connected with the standard hemostatic Y-valve 52 through a luer connector.
The conveying system for the pulmonary artery thrombus remover establishes a catheter channel in an interventional way, assists in completing the extraction of pulmonary artery thrombus, is beneficial to reducing the injury of large-area thrombus to human bodies and relieving symptoms such as dyspnea, chest pain and the like, and is specifically used according to the following principle:
as shown in fig. 9, first, after the dilator assembly 30 and the outer sheath 21 are assembled by the sheath connector 22 and the squeeze tube 223 is screwed and fixed, the guide wire is introduced through the middle perforation of the dilator tube 31 of the dilator assembly 30, a hole with a diameter of about 5mm is opened at the femoral vein, the guide wire is introduced into the target position of the pulmonary artery through the right femoral vein, the inferior vena cava, the right atrium, the right ventricle, the dilator assembly 30 passes through the outer sheath 21 of the outer sheath assembly 20, the distal end 32 of the dilator assembly 30 is exposed out of the distal end of the outer sheath 21 and serves as a guide for the outer sheath 21, the distal end of the dilator assembly 30 is introduced into the human body along the guide wire from the proximal end of the guide wire, the outer sheath 21 is carried to the target position of the blood vessel, a delivery path is formed, and the tasks of the dilator assembly 30 and the guide wire are completed. The extruded tube 223 of the sheath connector 22 is then unscrewed and the dilator assembly 30 is withdrawn quickly, the dilator assembly 30 and guidewire are withdrawn quickly from the vessel, whereupon the extruded tube 223 of the sheath connector 22 is locked and the outer sheath 21 in the delivery system reaches a location adjacent to the large area thrombus 91 in the vessel 90 under the guidance of the dilator assembly 30.
Next, the thrombus 91 is taken out by the following procedure:
in the first embodiment, an attempt is made to withdraw the thrombus 91 in the blood vessel 90 by using the negative pressure suction device 40, the negative pressure suction device 40 is connected to the extension tube 2212 of the three-way tube 221, the piston plunger 42 is pulled outward, and the thrombus near the distal end of the sheath tube 21 is sucked out by the negative pressure. Generally, the patient is sucked 2-3 times, and if the target thrombus 91 cannot be sucked, the first scheme is abandoned.
In a second embodiment, as shown in fig. 10, the thrombus removing device 54 is pushed into the inner tube 51, the distal guide head of the thrombus removing device 54 is exposed out of the inner tube 51, the thrombus removing device 54 is covered on the distal end portion of the inner tube 51, the proximal end of the push-pull rod 53 is exposed out of the hemostatic Y valve 52 of the thrombus removing assembly 50, the screw cap of the hemostatic Y valve 52 is screwed, and the thrombus removing device 54 is fixed. The thrombus removal assembly 50 is then advanced from the sheath connector 22 into the outer sheath 21 and gradually advanced to a first target site (the inner tube 51 passing through the distal end of the thrombus) and then into the vessel 90 through the passageway created by the outer sheath 21 to the front end of the thrombus 91. Multiple visualization points may also be provided on the distal end of the embolectomy 54 to indicate the location of the distal end of the embolectomy. After reaching the first target position, the sheath connecting piece 22 is screwed, the inner tube 51 is fixed, the inner tube 51 is not pushed any more, the nut of the hemostatic Y valve 52 is unscrewed, the push-pull rod 53 is pushed to the distal end, the thrombus remover 54 is released from the inner tube 51, the thrombus removing process is completed in the releasing process of the thrombus remover 54, and the nut of the hemostatic Y valve 52 is screwed for fixation. Unscrewing the sheath connector 22 to such an extent that the thrombus removal assembly 50 is integrally withdrawn, slowly withdrawing the inner tube 51 until after the thrombus and thrombus removal assembly 50 has been withdrawn into the outer sheath 21, screwing the sheath connector 22, and withdrawing the entire delivery system from the body to complete the thrombus removal.
According to the invention, the thrombus in the pulmonary artery is taken out by the outer sheath 21, the sheath connecting piece 22, the dilator assembly 30, the thrombus taking assembly 50 and the established catheter channel through intervening the blood vessel and establishing the conveying channel in the blood vessel to assist the thrombus taking device 54, so that the blood vessel is quickly dredged, the symptoms of chest pain, respiratory obstruction, even syncope shock and the like caused by large-area blockage of the blood vessel are relieved, the traumas are small, the effect is quick, the success rate of the operation and the operation convenience are improved, and the patient condition is stabilized in a short time.
The present invention has been described in detail with reference to the embodiments of the drawings, and those skilled in the art can make various modifications to the invention based on the above description. Accordingly, certain details of the embodiments are not to be interpreted as limiting the invention, which is defined by the appended claims.

Claims (13)

1. A pulmonary artery embolectomy delivery system, comprising:
an outer sheath tube assembly, the outer sheath tube assembly having: an outer sheath and a sheath connector in communication with the outer sheath;
characterized in that the sheath tube connector comprises:
a tee, the distal end of the tee being in communication with the proximal end of the outer sheath;
an elastic tube, the distal end of which is propped against the proximal end of the tee joint and is communicated with the tee joint;
a squeeze tube, the distal end of the inner half of the squeeze tube being abutted against and in communication with the proximal end of the elastic tube, the outer half of the squeeze tube being movably locked to the exterior of the proximal section of the tee;
locking the outer part of the distal section of the extrusion tube on the outer part of the proximal section of the tee joint so as to extrude the elastic tube to deform, thereby further extruding the outer sheath tube so as to seal the outer sheath tube;
the outer surface of the elastic tube is concave along the axial direction, the elastic tube is made of rubber, and is extruded by the extrusion tube to seal the outer sheath tube.
2. The pulmonary artery embolectomy delivery system of claim 1 wherein the extruded tube has:
a transition inner tube which is an inner half part of the extrusion tube, wherein the distal end of the transition inner tube is propped against the proximal end of the elastic tube and is communicated with the elastic tube;
the extrusion outer tube is an outer half part of the extrusion tube, is sleeved outside the transition inner tube and is fixedly connected with the transition inner tube, and is movably locked outside the proximal section of the tee joint.
3. The pulmonary artery embolectomy delivery system of claim 2 wherein the inner surface of the extruded outer tube has at least one internal thread and the proximal portion of the tee has at least one external thread at a corresponding location, the internal thread of the extruded outer tube being threadably received on the external thread of the tee to compress the elastic tube for deformation.
4. The pulmonary artery embolectomy delivery system of claim 3 wherein the inner surface of the extruded outer tube has two internal threads and the proximal portion of the tee has two external threads at corresponding locations, the two internal threads of the extruded outer tube being threadably received on the two external threads of the tee to compress the elastic tube for deformation.
5. A pulmonary artery embolectomy delivery system according to any one of claims 1 to 3, further comprising two gaskets, each abutting against a respective end of the flexible tube, whereby the distal end of the flexible tube abuts against the proximal end of the tee and the proximal end of the flexible tube abuts against the inner half of the extruded tube.
6. The pulmonary artery embolectomy delivery system of claim 5 further comprising a dilator assembly disposed within the outer sheath of the outer sheath assembly for guiding the outer sheath.
7. The pulmonary artery embolectomy delivery system of claim 6, wherein the dilator assembly has:
an expansion tube which can be arranged in the outer sheath tube in a penetrating way;
an expansion head end for guiding the outer sheath tube, connected to the distal end of the expansion tube and capable of being exposed from the distal end of the outer sheath tube;
and the expansion handle is connected to the proximal end of the expansion tube, can be exposed out of the proximal end of the outer sheath tube and is used for operating the expander assembly to conduct guiding action.
8. The pulmonary artery embolectomy delivery system of claim 1 further comprising a negative pressure aspirator in communication with the extruded tube of the sheath connector for aspirating thrombus under negative pressure.
9. The pulmonary artery embolectomy delivery system of claim 8, wherein the negative pressure aspirator has:
the negative pressure cylinder body is communicated with the third end of the tee joint, and a clamping column is arranged on the inner wall, close to the cylinder opening, of the negative pressure cylinder body;
the piston plunger is inserted in the negative pressure cylinder in a sealing mode, a plurality of buckles are arranged on the piston plunger at intervals, and the buckles can be matched with the clamping columns to form a clamping structure.
10. The pulmonary artery embolectomy delivery system of claim 9 wherein the negative pressure cartridge is in indirect communication with the third end of the tee via a tee extension.
11. The pulmonary artery embolectomy delivery system of claim 1 further comprising an embolectomy assembly disposed within the outer sheath of the outer sheath assembly for removing thrombus.
12. The pulmonary artery embolectomy delivery system of claim 11, wherein the embolectomy assembly has:
the inner tube is movably arranged in the outer sheath tube of the outer sheath tube assembly in a penetrating way;
a hemostatic Y-valve in communication with the proximal end of the inner tube and adapted to be exposed at the proximal end of the outer sheath assembly;
the push-pull rod can sequentially penetrate through the inner tube and the hemostatic Y valve, and the proximal end of the push-pull rod can be exposed out of the hemostatic Y valve;
the proximal end of the thrombus taking device is fixed at the distal end of the push-pull rod, and the thrombus taking device can be driven by the push-pull rod to be pressed and held in the inner tube and is used for taking thrombus near the distal end of the outer sheath assembly.
13. The pulmonary artery embolectomy delivery system of claim 6 further comprising a guidewire along which the dilator assembly moves the outer sheath assembly into the body, the outer sheath assembly being guided to establish a sheath channel.
CN202111103019.5A 2021-09-18 2021-09-18 Delivery system for pulmonary artery embolectomy Active CN113827312B (en)

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