CN106333749A - Unfolded catheter - Google Patents

Unfolded catheter Download PDF

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Publication number
CN106333749A
CN106333749A CN201610855500.2A CN201610855500A CN106333749A CN 106333749 A CN106333749 A CN 106333749A CN 201610855500 A CN201610855500 A CN 201610855500A CN 106333749 A CN106333749 A CN 106333749A
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CN
China
Prior art keywords
conduit
expansion
distal tip
handle
plunger
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.)
Granted
Application number
CN201610855500.2A
Other languages
Chinese (zh)
Other versions
CN106333749B (en
Inventor
D·奥康奈尔
E·利杰格伦
D·H·迪拉德
H·X·冈萨雷斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jieruishi Co., Ltd
Original Assignee
Spiration Inc
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Filing date
Publication date
Application filed by Spiration Inc filed Critical Spiration Inc
Priority to CN201610855500.2A priority Critical patent/CN106333749B/en
Publication of CN106333749A publication Critical patent/CN106333749A/en
Application granted granted Critical
Publication of CN106333749B publication Critical patent/CN106333749B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61B17/12104Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • 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
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F2/9517Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • 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
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044Oesophagi or esophagi or gullets
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/046Tracheae
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • 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
    • A61M25/0051Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • 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
    • A61M25/0053Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

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

Abstract

The invention discloses an unfolded catheter. Preferably, one medical device (such as a valve) is conveyed to a position, such as a trachea, in a body of a patient. Preferably, the unfolded catheter can be configured to combine with a tracheoscope. In certain implementation schemes, a locking lever is arranged so as to reduce the possibility of unfolding the device by accident; and the locking lever is convenient to reset after being used and the device is allowed to be unfolded for a plurality of times.

Description

Launch conduit
The application is the application for a patent for invention of entitled " the expansion conduit " submitted on May 13rd, 2011 2011800024509 divisional application.
Background technology
Technical field
Embodiment of the present invention relates in general to field of medical devices, more particularly, to using conduit by device The mthods, systems and devices that such as valve or other medical treatment device launch and/or implant.
Description of Related Art
Pulmonary disease such as copd, chronic bronchitiss and emophysematous sickness rate, popularity degree and cost All improving.New Therapeutic Method includes the lung volume reduction treatment by selecting minimally invasive non-surgery operation to carry out.In these treatments In situation, valve can be implanted in the lung of patient, to reduce size and/or the treatment gas leakage of lung.It is thus desirable to a kind of be used for safety And as one man such valve or other medical treatment device are implanted patient's trachea (airways) thus treat pulmonary disease equipment and Method.
Content of the invention
Each embodiment of the present invention relates generally to, via conduit, medical treatment device (such as valve) is introduced internal dress Put, system and method.Conduit is a kind of to be inserted into internal or body cavity, pipeline or vascular pipe.Conduit can be used for permission will Fluid is discharged or is injected to internal, or provides entrance internal path by surgical unit and/or implantable device.In order to So that implantable device is entered internal, implantable device can be inserted in conduit first.In order to device is delivered to suitably Air flue in position, such as lung, tracheascope or other devices can be provided with a service aisle, and described conduit can introduce this work and lead to In road.Then the conveying of device and the expansion to being inserted in described conduit can be carried out.In a preferred embodiment, fill Valve is delivered to one of lung qi pipe position by the conduit being loaded with valve.
Using method described herein, system and device, can be by valve or other medical treatment device (extensible or other forms ) introducing conduit or other launch apparatus.Have been loaded into into described conduit or other expansion in described valve or other medical treatment device After apparatus, by described valve or other medical treatment device implantation or patient body can be positioned at using described conduit or other apparatus that launches Interior.Preferably, described valve or other medical treatment device are loaded in described conduit or the distal tip region of other expansion apparatus The chamber of setting or other space.In some embodiments, described conduit or other launch apparatus can be loaded into tracheascope or its The service aisle of its such apparatus, and walked (navigated) to suitable expanded position, the such as trachea of patient.
The embodiment of described apparatus can have additional feature (alone or in combination), and these features can show Help advantage and the use of expansion aspect.For example, it is possible to one locking lever of setting, it reduces or eliminates valve or other device meaning The probability of outer expansion, also can reset after the expansion, to carry out multiple device expansion.Additionally, a clamping part can be arranged, It is c shape handle in certain embodiments, it could be sandwiched in tracheascope, to help valve or other medical treatment device to launch, also simultaneously One ergonomic hand knob of setting.Telltale mark also can be arranged on this apparatus, especially in the far-end near apparatus, described The expanding unit bit alignment that telltale mark can help operator by implantable device and select.Distal tip part also can be constructed Become cage sleeve-like structure, and one or more fenestras (fenestration) can be provided with, described fenestra allows to observe and confirmation is described Valve or medical treatment device have correctly been loaded in distal tip.Certainly, also will be discussed in detail other features and thin herein Section.
In one embodiment, describe for a device being launched the expansion conduit into pulmonary, wherein this expansion Conduit includes:
Including the near-end of handle portion, described handle portion includes a plunger, and this plunger is by a moveable handle Around described moveable handle is configured to axially upwardly slide at least one of side of the length along described plunger Dynamic, and wherein said plunger also includes the locking lever that can switch between locked and unlocked positions, this locking lever It is configured as, in described latched position, preventing described moveable handle from sliding to described plunger in the proximal direction, but It is allowed to described moveable handle slides in the proximal direction when in described unlocked position, and wherein said locking lever is also It is configured to be reset to latched position;
Conduit shaft portion, this conduit shaft portion includes the stable line within catheter shaft and described catheter shaft, wherein said leads Pipe axle is fixed to described moveable handle in the proximal end of this catheter shaft, and wherein said line of stablizing is fixed to described post Plug;And
Distal tip part, it is configured to receive in a chamber by a medical treatment device, wherein said distal tip Part is fixed to the far-end of the catheter shaft of described hollow, and described distal tip part also includes receiving the propulsion in described chamber Device plunger, described propeller plunger connects to the described far-end stablizing line.
Some embodiments provide makes the plunger of near-end include c shape handle in its near-end.In some embodiments, described Locking lever includes being configured to the lock tab engaging with the recess in described moveable handle.Described locking lever also may be used Including the spring being attached to described locking lever, this spring is configured in described medical treatment device from described expansion conduit exhibition After opening, described locking lever is reset to latched position.
In some embodiments, described conduit shaft portion includes high flexibility (flexibility) area positioned at its far-end Domain, described high flexibility region may include indenting (jigsaw) construction, snake construction or overlapping straight cuts portion.
Other embodiments provide makes described distal tip portion divide including cage set, and this cage set is configured to at least one Receive the chamber of a medical treatment device.Described cage set can have the stay arrangement forming spiral structure, and may include one or more Big fenestra.In some embodiments, one or more of big fenestras are configured to allow to observe and confirm described doctor Treat device already loaded in described chamber.Described distal tip part may also include at least one telltale mark, described positioning Labelling is configured to indicate the substantially expanded position of described medical treatment device.In some embodiments, described telltale mark is yellow Color, two extra black bands are located at both sides.In some embodiments, the far-end of described conduit shaft portion is also included at least One long telltale mark.
In some embodiments, described handle portion also includes the strain relief member of a frustum of a cone, and it is around institute State the proximal end region of conduit shaft portion.Some embodiments may also include outer sheath, and it is at least about described conduit shaft portion Proximal end region.Preferred embodiment can be configured to be loaded into a tracheascope.
Further embodiment provides a kind of method that a medical treatment device is expanded to patient pulmonary, the method bag Include:
Described medical treatment device is loaded in the chamber of distal tip part launching conduit;
Described expansion conduit is introduced a tracheascope;
Lung qi pipe is inserted in described tracheascope;
Described tracheascope is made to walk to the part to be treated of lung qi pipe;
The part to be treated of described lung qi pipe is partly gone up at least with positioned at the described distal tip launching conduit One telltale mark be aligned;
The unblock supravasal locking lever of described expansion;And
Described medical treatment device is expanded to the part to be treated of described lung qi pipe.
In some embodiments, after described device expansion, described locking lever resets to latched position.At other In embodiment, described expansion conduit includes the c shape handle in its near-end, and wherein said c shape handle is attached to described trachea A part for mirror.In a further embodiment, the step that described tracheascope is walked is made also to include chasing after using radial imaging instrument Launch conduit described in track.
Brief description
Accompanying drawing below with reference to each embodiment describes the aforementioned of the present invention and other features, aspect and excellent in detail Gesture, described accompanying drawing is intended to show that and the unrestricted present invention.Described accompanying drawing includes following figure, wherein:
Fig. 1 shows the side view of an embodiment of conduit.
Fig. 2 shows the close-up side view of an embodiment of the handle portion of conduit.
Fig. 3-4 respectively illustrates the top and bottom perspective views of an embodiment of the handle portion of conduit.
Fig. 5 a-b shows the left view of an embodiment and the right view of conduit.
Fig. 6 shows the sectional view of an embodiment of catheter shaft.
Fig. 7 is the sectional view of an embodiment of the handle portion of conduit.
Fig. 8 shows the close-up section of an embodiment of occlusion of catheter mechanism.
Fig. 9 a-b shows the close up view of the skewer of an embodiment that catheter shaft is attached to modular catheter.
The embodiment that Figure 10 a-c shows the high flexibility region presenting on catheter shaft.
Figure 11 a-b respectively illustrates the enforcement of the distal tip without loading valve and the conduit being wherein mounted with valve The close up view of scheme.
Figure 12 a-b respectively illustrates the enforcement of the distal tip without loading valve and the conduit being wherein mounted with valve The close-up section of scheme.
Figure 13 is the close up view of the distalmost end of the distal tip of an embodiment of conduit.
Figure 14 shows the embodiment that can be used for the connector mechanism that distal tip is attached to catheter shaft.
Figure 15 shows the close up view of the distal tip of the embodiment of the catheter shaft being added with localizer markers.
Figure 16 a-h shows the different embodiments of the distal tip of conduit.
Figure 17 is the view of the embodiment of the conduit and valve loader system encapsulating.
The embodiment that Figure 18 a shows the conduit of tracheascope being loaded into insertion lung qi pipe.
Figure 18 b shows the embodiment with the conduit of clamping part being attached to tracheascope.
Figure 19 a-c shows how the blocking mechanism in an embodiment being presented on modular catheter operates.
Figure 20 a-c shows, using the valve of an embodiment being loaded into conduit, valve is launched air inlet pipe.
Specific embodiments
Referring now to the Description of Drawings conduit development system of one or more embodiments and the associated components of system And part.It is not intended to be explained with any limitation or ways to restrain in terminology used herein provided herein.On the contrary, only The detailed description of the embodiment of coupling system, method and associated components uses term.Additionally, each embodiment may include New feature, the single feature in these features does not individually make expected contribution, or it is not considered that single feature is for reality Existing invention described herein is requisite.
Terms used herein " valve (valve) ", " extensible medical treatment device (deployable medical Device) ", " medical treatment device (medical device) " and " device (device) " is the interchangeable terms of broad sense, unless separately Point out, in its implication, described term can include support, valve, lung volume reduction valve, air bag, probe, labelling (bag without limitation Include the reference mark of radiopaque labelling and other forms), anchor or any other be configured to load or introduce lead Pipe or other medical treatment device (deployable or other forms) launching apparatus and subsequently being conveyed or launch.While characterized as Some embodiments be directed to medical treatment device be deployed in trachea, but present disclosure not limited to this, but be deployed to Such as but not limited to other vasculars of humans and animals, path and body cavity.In certain embodiments, described valve and/or medical treatment dress Putting is type disclosed in U.S. Patent No. 6,293, No. 951 or the 7th, 757, No. 692, and described two patents are each all received Enter herein.
Fig. 1 shows an embodiment launching conduit system 101.It is coefficient not that this system 101 includes some Same part.The near-end of system 101 includes handle portion 103, and this handle portion is attached to conduit shaft portion 105, conduit shaft portion The 105 distal tip parts 107 terminating at system 101 far-end.In a preferred embodiment, proximal handle portion 103 Connect to distal tip part 107 through described conduit portion 105, described distal tip part 107 preferably comprises to use system The medical treatment device of 101 proper site to be extended to.In some embodiments, distal tip part 107 can comprise (or to be joined It is set to reception) device of valve in trachea path for example to be deployed in.
Fig. 2-5 shows other external views of handle portion 103.Handle portion 103 is preferably suitable to user and holds or hold Hold, and include some parts.Handle portion 103 includes the clamping part 202 connecting to plunger 204.Movably handle 206 is attached To plunger 204, for example, can arrange around plunger 204.Conduit shaft portion 105 connects to handle portion in the far-end of handle portion 103 Divide 103.
The clamping part 202 of handle portion 103 may be structured to, with recess, be included in distal tip part when preparing expansion During device in 107, this recess can allow the thumb of user to hold or catch handle portion 103.As shown, clamping part 202 can form c shape clamping part.Clamping part 202 can adopt other shapes, and such as but not limited to, clamping part 202 can have u shape, v Shape or the inner surface of depression.In some embodiments, following article Figure 18 b describes in further detail, and clamping part 202 can be attached To a device, such as endoscope, or more specifically it is attached to tracheascope.The clamping holding or operating being available for users to The miscellaneous part of portion 202 and system 101 can be provided with anti-skidding or rubber processing coating, extra to provide to user Grip.
Clamping part 202 is attached to plunger 204.Plunger 204 can be provided with ergonomics finger embossing 205, when operating system 101 When, ergonomics finger embossing 205 can provide more firm or comfortable gripping for the finger of user.
Movably handle 206 is configured to movably engage with plunger 204, so that moveable 206, handle As can be along at least a portion of plunger 204 in longitudinal axial direction slide anteroposterior.Position shown in from Fig. 2, moveable handss Handle 206 can shift to clamping part 202 in proximal direction.
In the far-end of moveable handle 206, firm fin (securement tab) 208 and locking lever 210 can be attached It is connected to plunger 204.Locking lever 210 is configured as in the latched position illustrating, it is engaged with moveable handle 206, To reduce or to eliminate the probability that clamping part 202 shifted to by moveable handle 206 in proximal direction.Movably handle 206 is excellent Selection of land includes ergonomics adminicle such as ridge 207, and it makes user can easily grasp during launching medical treatment device Make and pull moveable handle 206.In some embodiments, all parts of moveable handle 206 or a part can It is provided with anti-skidding or rubber processing coating, to provide extra grip to user.
Handle portion 103 may also include strain relief member 212.Preferably, this strain relief member 212 is attached to handle Part 103, and be made up of following elastomeric material, such as polymer, including (such as but not limited to) rubber, thermoplastic elastomer (TPE) (such as santoprenetm,), polyurethane, polrvinyl chloride,And siloxanes.Strain relief member 212 Shape can be approximately conical or conical butt, the central opening with longitudinal extension, this central opening is configured to Fit tightly with the outer sheath 316 (if being provided with) of conduit shaft portion 105 or catheter shaft 302.Strain relief member 212 can be Reduce the probability of conduit shaft portion 105 kinking or bending, especially near the abutment of conduit shaft portion 105 and handle portion 103 It is when conduit shaft portion 105 is inserted into instrument (such as tracheascope), and when being operated in use.
Referring now to Fig. 6, it illustrates the sectional view of conduit shaft portion 105.Catheter shaft 302 is hollow, and is included therein The stable line 304 of longitudinal extension.Catheter shaft 302 preferably constructs (for example a kind of metal by elastic and durable (robust) material Or various metals), described material stretch-proof and plastic deformation, keep enough flexibilities, to be conducted through zigzag channel simultaneously Converging duct similar with other.Suitable metal may include rustless steel, Nitinol (nitinol) etc..In some embodiments, Polymer pipe respond well, some embodiments for example can by continuous polymer extrude manufacture.These extrusions may also include Interweave to obtain extra intensity and ruggedness, and can be by polymer such as polyimide features.Stablize line 304 same Sample can be constructed by similar material.
In some embodiments, smooth coating or material can be added into one of stable line 304 or catheter shaft 302 Or both, this can help both parts more freely mutually to slide through, and does not totally have obstruction or viscous card.For example, gather Compound (such as ptfe or Parylene) can be applied on stable line 304.Coating (such as fep) also can be extruded into stable Line.Thermal polycondensation compound (such as ptfe or polyethylene) also can be added into stable line 304.
In some embodiments it is preferred that ground, described stablize the diameter that line 304 can have change along its length.This diameter The mode that for example can continuously or gradually reduce changes, or is changed in stepwise (stepwise) mode.Be not intended to theoretical It is believed that the following embodiment stablizing line 304 is favourable in the case of restriction, i.e. in near-end (i.e. towards handle Part 103) there is larger diameter, to reduce or to eliminate the probability of flexing in the case of applying higher load;Court simultaneously Far-end (i.e. near tip portion 107) and there is less diameter, to provide extra flexibility.In one embodiment, surely Alignment 304 proximally starts the diameter always with 0.020 inch, until by outer sheath 316, approximate 1 inch just changes.Surely The diameter stepwise of the remainder of alignment 304 is changed to 0.016 inch.It is approximate 0.022- that this embodiment can be used on internal diameter In 0.024 inch of catheter shaft 302, so that catheter shaft 302 and stablize gap on each side between line 304 and in near-end be Approximate 0.001-0.002 inch, far-end is 0.003 inch.
With reference to Fig. 7, it illustrates the sectional view of handle portion 103.Fig. 8 shows the close up view of this sectional view.Excellent one In the embodiment of choosing, clamping part 202 connects to stablizing line 304, although in some embodiments, stablizes line 304 and also can connect It is connected to plunger 204, or be coupled instead to plunger 204.Stablize line 304 to be disposed in catheter shaft 302, catheter shaft 302 is excellent Selection of land is configured to slide with regard to stablizing line 304 in a longitudinal direction.
In certain embodiments, crimp tube 305 connects to clamping part 202 for stablizing line 304.Crimp tube 305 is excellent Selection of land is by the metal construction harder than stablizing line 304, such as stainless steel alloy (such as ss304), and is formed as hypotube (hypotube).Preferably, crimp tube 305 is crimped onto the near-end of stable line 304, and the near-end of crimp tube 305 is maintained at clamping Inside portion 202, the far-end of crimp tube 305 is maintained in the remainder of the main body of plunger 204.In some embodiments, Crimp tube 305 can partly extend on catheter shaft 302, for example, extend 0.1 inch of short length, because when power applies to catheter shaft When 302, this can provide extra anti-flexibility for catheter shaft 302.In some embodiments, crimp tube 305 can have approximately 0.039 inch of internal diameter, 0.010 inch of wall thickness.
Catheter shaft 302 connects to moveable handle 206 through a skewer 216.Because moveable handle 206 is preferred Be configured to along plunger 204 slide anteroposterior, and because moveable handle 206 is attached to catheter shaft 302, removable Dynamic handle 206 mobile can lead to catheter shaft 302 with respect to stablize line 304 corresponding movement.As discussed below, this shifting The dynamic device ejection allowing to be contained in distal tip 107 and expansion.Additionally, locking lever 210 can be provided with a lock tab 222, This lock tab 222 is engaged with the recess 220 on moveable handle 206, thus helping reduce or eliminating moveable handle 206 probabilities slided along plunger 204.This set can be used for helping reduce or eliminates unexpected or prematurely from conduit system Unite 101 expanding units.In certain embodiments, catheter shaft 302 may be alternatively connected to plunger 204, and stablizing line 304 can be through institute State skewer 216 to connect to moveable handle 206.
Catheter shaft 302 is preferably fixed to handle portion 103, and in certain embodiments, one or more middle structures Part can form a part for this connection.In some embodiments, referring now to Fig. 9 a-b, catheter shaft 302 can be fixed in fork-shaped Between component, such as skewer 216, and catheter shaft 302 for example can be clamped in the recess of fork-shaped intermediate member.Skewer 216 Body connects to moveable handle 206 again.For clear, eliminate moveable handle 206, but moveable handle 206 and its The relation of his part can be found out in Fig. 7-8.
Skewer 216 preferably includes at least two prongs 217.These prongs 217 have an interval each other, between being somebody's turn to do Every the diameter less than catheter shaft 302.In order to connect catheter shaft 302 to skewer 216, catheter shaft 302 (is preferably configured with justifying Shape cross section) can thus have the one or more breach being formed on or chamber 308.Described breach or chamber 308 allow to lead Pipe axle 302 receives in the interval between two prongs 217, this is because chamber 308 will lead to along the distance of catheter shaft 302 Pipe axle 302 has a segment distance of less cross section, with allow catheter shaft 302 be inserted and fixed in two skewers 217 it Between interval in.Correspondingly, axial restraint can be formed between catheter shaft 302 and skewer 216 connect.Because stablizing line 304 It is therefore necessary to notice that relatively freely moving of catheter shaft 304 is not substantially interfered in breach or chamber 308,310 in catheter shaft 302 Dynamic, or do not cut into catheter shaft 304.
Test it has been shown that the skewer 216 by stainless steel construction of an embodiment (skewer 216 can be by appointing What suitable constructed of rigid materials, for example, include stainless metal) power more than 20 pounds can be born before disabling.Because making User can not possibly apply so big power during launching, and therefore this construction makes system 101 more likely remain intact, and forked The inefficacy of thing 216 is likely to result in catheter shaft 302 and is separated with the remainder of system 101.
Referring again to Fig. 1, outer sheath 316 also can be arranged on conduit shaft portion 105.Outer sheath 316 can be located at catheter shaft Between 302 and strain relief member 212, and can be used for (together with strain relief member 212, if being provided with strain relief structure If part 212) so that the kinking of conduit portion 105 and torsional load is minimized.For guaranteeing being reliably connected of sheath 316, preferably will Sheath 316 is fixed to plunger 204, for example, pass through insert moulding (insert molding) or binding agent.In some embodiments, Outer sheath size between 22 to 39 inches, wall thickness between approximate 0.005-0.015 inch, preferably 0.010 inch.Preferably Ground, outer sheath 316 has space or gap at itself and catheter shaft 302 between.In some embodiments, the chi in this gap Between the very little inch in about 0.003-0.010, preferably every side is 0.005 inch.It is configured to aseptic (for example making at some Use eo sterilization method) embodiment in, the gap between catheter shaft 302 and outer sheath 316 is designed to permit Permitted the abundant flowing of antibacterial between two parts.
Outer sheath 316 is preferably constructed by following material, including for example with single polymer extrusion (single polymer Extrusion the polymer) being formed, such as hdpe, PA-12,Polyurethane, or the mixing of above material Thing.In some embodiments, outer sheath 316 is formed by two kinds of different materials co-extrusions.In outer sheath 316 towards catheter shaft 302 Side, lubricious material, such as hdpe, fep can be used, or other suitable material.In the outside of sheath 316, can be using polymerization Thing is for exampleOr PA-12 or other suitable material are to obtain the balance between each factor as follows, institute Factor of stating such as can promote ability (for example limiting the amount of power that user can apply), mechanical strength (such as under a load anti- Deformability), buckle resistance and the friction within tracheascope and manufacturability.In some embodiments, ray can not Material (such as barium sulfate) can be included into sheath 316 and/or the other elements of conduit system 101 thoroughly.
With reference to Figure 10 a-c, a series of cutting parts can be formed along the substantially all or part of of catheter shaft 302.These cuttings Portion can limit one or more flexible regions 330 increasing, and region 330 usually can be than remaining uncut catheter shaft 302 Preferably bending or warpage.If in some embodiments it has been found that a part for the far-end of catheter shaft 302 has cutting Enter high flexibility region 330 therein, then conduit system 101 show must well, this is because the distal portions of catheter shaft 302 need more The bending of big degree, with by for example tortuous trachea path.The flexibility in high flexibility region 330 can wanting according to concrete application Ask and be designed.For example pass through to change the thickness of catheter shaft 302, the cutting in material and high flexibility region 330 used in it Interval between portion, pitch (pitch) and angle are changing flexibility.Preferably, cutting part is along catheter shaft 302 in a spiral manner Extend.
Additionally, high flexibility region 330 needs not be the single pitch shown in Figure 10 a, but with reference to Figure 10 b, high flexibility area Domain 330 can be alternatively variable pitch, and wherein interval or pitch can be changed with consecutive variations or stepwise.Although additionally, at this A little cutting parts shown in figure can make continuously single cutting part, but can use one or more discontinuous cutting parts Manufacture high flexibility region.In these figures, the cutting part constituting high flexibility region 330 is to form sawtooth or zigzag pattern " indenting " configuration is made.Other feasible cutting parts are that following article Figure 16 b and c illustrates and " snake is discussed (serpentine) " configure.In the configuration of this snake, cutting part is more smooth than indenting pattern, more round, and has longer Amplitude.Other cutting part types are also feasible and are contemplated that, including straight cuts portion, local or dotted line cutting part, in a zigzag Cutting part, sinusoid cutting part etc..
Figure 10 c shows an embodiment in the high flexibility region 330 including overlapping discontinuous straight cuts portion, often The half of the circumference approximately about catheter shaft 302 for the individual cutting part extends.In this embodiment, punching 331 may be provided at each One or more ends of cutting part.In some cases, punching 331 can be used as the cut work for producing cutting part A part for skill and make, but these cutting parts can use any suitable technique manufacture, such as chemical etching.Punching 331 Can be additionally used in providing extra intensity to catheter shaft 302, this is because believing that punching 331 can help reduce or eliminate in catheter shaft The probability of cracks can spread during 302 experience different stress.
In practice, the processing of high flexibility region 330 and the cutting part constituting this high flexibility region 330 can exist as desired Appropriate balance is found between the flexibility requiring and cutting part type.For example although wider or larger cutting part can provide volume Outer flexibility, but these can weaken catheter shaft 302 to unacceptable degree in some cases.Different cutting part types Also more or less satisfactorily can work in fatigue test.Additionally, some cutting parts may result in the part in high flexibility region 330 The service aisle of abrasion tracheascope, but the rear processing after cutting part produces may include and at least can partly mitigate this misgivings The step of such as deburring or ultrasound wave cleaning.Above-described cutting part type also can be according to one or more high flexibility regions 330 length and adjust.
In preferred embodiments it has been found that size is in 3 to 6 inches of high flexibility region 330 (between cutting part Pitch is between 0.010 to 0.100 inch) can effectively work.It has been found that in some embodiments, cutting part width (is cut Seam) it is gratifying between 0.0015-0.0030 inch.
In certain embodiments, preferably flexible cover sheet such as polymer or heat-shrinkage material are adopted extremely Cover high flexibility region 330 less.This protective layer can at least partly reduce the service aisle of the tracheascope leading to due to cutting part Internal abrasion, and also can reduce or eliminate catheter shaft 302 damage or excessively elongation probability, this can help so that conduit can Launch for multiple.Additionally, this protective layer can also be smooth or lubrication, thus allowing catheter shaft 302 in tracheascope work Make more easily to slide in passage.
Referring now to Figure 11 a-b and 12a-b, distal tip part 107 can be bonded to conduit shaft portion through connector 402 105.More specifically, in some embodiments, connector 402 connects outer catheter axle 302 to distal tip part 107.? In preferred embodiment, distal tip part 107 may include cage set 404, and this cage set 404 connects to conduit through connector 402 Axle 302.This cage set 404 can be made up of one or more material durable enough, and described material includes metal, for example rustless steel and Nitinol.In some embodiments, cage set 404 can be constructed by preformed tubing, and some other embodiments can have Have by the cage set 404 of the flat construction of material, described material is subsequently wound formation pipe in longitudinal direction or the hand of spiral.
Distal tip part 107 is preferably configured as comprising position chamber 405 in the inner, and the size in chamber 405 is designed to Accommodate suitable device subsequently to be unfolded.Preferably, cage set 404 includes covering the chamber 405 of 404 inner spaces positioned at cage.
In some embodiments, as shown in Figure 11 b and 12b, chamber 405 can accommodate medical treatment device, such as valve 500.? In some situations, using in us serial number 12/249,243 and 12/422, the valve loader of type described in 179, can pass through remote Valve 500 is loaded into chamber 405 by end opening 410, and described us serial number 12/249,243 and 12/422,179 here is each received in full Enter herein.Once being loaded into chamber 405, the proximal end in abutment of device (such as valve 500) is against propeller plunger 408, propeller plunger 408 then connect to stablizing line 304.In use, moveable handle 206 is near in handle portion 103 with regard to plunger 204 End is moved, and leads to cage set 404 to be retracted with respect to propeller plunger 408, thus being contained in the dress chamber 405 from opening 410 release Put (such as valve 500).
Fenestra 409 is preferably located at least a portion of cage set 404, and can be used for improving the device being located therein can Depending on property and the flexibility of improving distal tip part 107.Remaining stay 411 forms cage set or tower structure, and may include Spiral or interlaced helical pattern, however different configurations and pattern are also feasible.Fenestra 409 for example can be cut by laser Cut.It is also with other methods, such as photochemistry milling.
Preferably, cage set 404 also includes one or more big fenestras 413.This big fenestra 413 facilitates look at position Device in chamber 405, and confirm device by suitably or have been properly loaded in chamber 405.Big fenestra 413 can be additionally used in One clear area being used for telltale mark band or other telltale mark (being discussed in detail below) is provided.Preferably, whole cage set 404 Constructed by single piece of material, and include the distal portions of the cage set 404 at edge 415 and can connect to cage set 404 through longitudinal stay 414 Proximal part.
It is advantageously that coated distal end tip portion 107 and cage cover 404 inside in the manufacture of distal tip part 107 Part and/or exterior section.For example, the softer material (such as polymer) of coating can be effectively prevented from when using conduit to body The injury of body tissue, and help distal tip part 107 freely to slide in the service aisle of tracheascope or Other Instruments.This Outward, coating conduit interior section can help reduce or eliminate to the destruction being loaded in medical treatment device therein, or reduce or Eliminate the probability hindering medical treatment device to launch.
Therefore, some embodiments provide the lining being located at least a portion of inner surface of cage set 404 or chamber 405 (being for example made up of polymer such as politef), in conjunction with the outer surface being located at least in distal tip 107 part On lining (can by polymer for exampleComposition).
In some embodiments, these coating or lining can soft heat (reflowed) to distal tip part 107.Make Motive axle, can apply heat with by these lining soft heats in the metal part of far-end 302.Preferably, selected lining with regard to Fenestra 409,413 is at least partly transparent, so that loading medical treatment device therein can be checked.Along distal tip 107 not Same part, can use different polymer and polymer type, wherein for example a part only along distal tip 107 uses Transparent polymer, and along distal tip 107 a different piece use opaque or coloured polymer, with allow by Conduit is specially processed into expected application and purposes.Discuss in following article and Figure 15, these polymer coatings and soft heat are also Telltale mark can be incorporated in distal tip part 107 or in distal tip part 107.Can use different methods for remote End tip portion 107 coating, including immersion coating, extruding, applies heat-shrinkage material etc..
In a preferred embodiment, around the edge 415 of the opening 410 positioned at distal tip part 107 far-end It is configured to smooth and atraumatic, to reduce or to eliminate in the device that insertion and expansion are located in chamber 405 to body group The probability of the damage knitted.
Preferably, with reference to Figure 13, edge 415 includes a series of little weld part circumferentially around opening 410 (welds), described weld part for example can be made using laser welding, to provide smooth, rounded ends.In this case, side Atraumatic tip thus can be configured to supply along 415, this tip make the obstruction to the device launching from chamber 405 or its His clamping is minimum, also makes it durable simultaneously and can support multiple use.In other embodiments, edge 415 can be gathered Compound or other soft material layer cover.
Now referring again to Figure 11 a-b and 12a-b, in some embodiments, via cage set 404 or catheter shaft 302 remote End, connector 402 can be along being bonded to the border of distal tip part 107 by roll welding (seam-welded) by connector 402. This welding is preferably as it provides the more smooth transition from conduit shaft portion 105 to distal tip part 107, Thus reduce the operation easier of operator, and the movement of smooth and continuous during launching for the offer system 101 is provided.Can also Using spot welding, it should be noted that reducing the size of spot welding, prevent from excessively projecting, this is because there is this weld part in tracheascope The danger inside blocked or hinder.
With reference to Figure 14, some embodiments provide by the connector 402 of multi-part design construction.In these embodiments In, compression circular cone 430 for example passes through to be attached to the far-end of outer conduit axle 302.Lasso (ferrule) 432 for example passes through Weld or be attached to far-end 402 simply by mechanical interlocking, lasso 432 subsequently can be forced past compressing circular cone 430, with The near-end of cage set 404 is clipped in the middle.This interlocking connects and includes connector 402, and is formed and can resist connecting by force of most pulling force Connect.Test sample can bear at least pulling force of 100n.
Turning now to Figure 15, an embodiment of system 101 can be provided with telltale mark.These telltale marks for example can be arranged In a part for distal tip part 107 and the far-end of conduit shaft portion 105.Generally, telltale mark helps operator to determine System 101 is with regard to the position of external object.Telltale mark can be visual, therefore in visibility constrained environment for example It is useful in the field of view scope seen by tracheascope.More specifically, telltale mark can help to as being loaded in Medical treatment device in conduit selects and instruction is suitable launches position, and be used for allowing operator determine conduit whether from The service aisle of tracheascope or other conveyer device extend too remote.
Some embodiments can be provided with one or more telltale marks, such as line 445,446,447, and these telltale marks can Help select for the medical treatment device loading in the catheter and instruction suitable expansion position.Herein, when the conduit accommodating device It is loaded into tracheascope, and when being directed to a part (the such as lung qi pipe) of body requiring treatment, operator can use line Position to be unfolded with medical treatment device for conduit is aligned by 445, because line 445 can indicate that medical treatment device discharges from opening 410 Apparent position.In some embodiments, device can be the valve 500 launching in trachea, and in these cases, line 445 Generally will seal, with the film of valve 500, the airways region propping up to be aligned.These embodiments are below and Figure 20 a-c is further Describe in detail.
Line 445 may be particularly advantageous for helping seeing suitable expansion position by trachea sem observation passage, and some enforcements Scheme make line 445 by other black or have the color belts 446,447 of different contrasts around or be clipped in the middle, to provide Extra contrast.Although line 445 can be marked at by far-end end using suitable means such as bat printing or ink jet printing Taper divides 107, it is contemplated that biocompatibility, line 445 sometimes must be made not adopt the pigment of exposure in its construction.At this In a little situations, some embodiments can use the labelling band around distal tip part 107 arrangement.These labelling bands can be by being polymerized Thing band forms, for example by heat-shrinkable polymer for exampleConstruction.Due to having been found that yellow line 445 It is favourable in some applications, therefore golden labelling band can be enclosed within distal tip part 107.Labelling band can be by any conjunction Suitable material is constituted, and is preferably made up of the material of highly-visible.It has been found that the material of the gold or platinum being for example mixed with iridium is can The material accepting.Optionally, the labelling band as line 445 can be encapsulated in below the lining described in softening-melting process above, Or be encapsulated in that one other and preferably at least partially transparent polymer (for example) below layer.
In some embodiments, line can be formed by a row or a series of fenestra are cut into distal tip part 107 445 or other telltale marks, so that do not need extra material to form corresponding telltale mark.Although additionally, retouching above The line 445 stated is located in distal tip part 107, but line 445 can be placed in other portions of system 101 by other embodiments Point.For example, line 445 can be on stablizing line 304 or plunger 408, wherein if necessary, far-end end can be cut into associated Taper divides 107 aperture or fenestra, to allow to see line 445.
Additionally, some embodiments can arrange long telltale mark 448, for example, it is located at the distal portions of catheter shaft 105.Should Long telltale mark 448 can serve as the cautionary characteristic to operator, and warning conduit system 101 has extended through tracheascope too Far.This long telltale mark 448 is preferably coloring or coloured, for example, contrast color (such as yellow), easily to lead Pipe will be seen by operator when will extend through tracheascope.Can be using (the description for line before inclusion of any suitable means 445th, 446,447 means) long telltale mark 448 is placed on catheter shaft 105.Preferably, long telltale mark 448 is permissible Constructed by suitable heat-shrinkable polymeric thing, in some cases, this polymer can subsequently be gathered by pure or colourless protection Compound layer is covered.In some embodiments, the size of long telltale mark 448 can between 5 to 10 inches, preferably 6 Inch, and may be located at approximate 2 inches of distal tip.
Although telltale mark discussed above generally refers to visual indicant, positioning mark used in system 101 Note is also configured to position using other means.For example, any telltale mark or line 445,446,447,448 can by ray not Material (such as barium sulfate) construction thoroughly, or include radiopaque material (such as barium sulfate), to use radiographic imaging method To position.In the compatible embodiment of the mri of system 101, mri contrast medium also can be incorporated into telltale mark.Active (carried For power) or passive (for example passive rfid) witness marker lamp (beacon) also can combine into distal tip part 107, described Witness marker lamp together can be worked with above-mentioned telltale mark, or replacement telltale mark discussed above works, and described Telltale mark lamp can work together with mapping software, with the position of real-time tracing distal tip part 107, and does not need requirement to regard Feel and confirm distal tip part 107 with respect to the position launching position.These telltale marks can also be with reference to multiple localization methods Mixed positioning labelling, the such as not only impermeable but also visual telltale mark of ray.
Figure 16 a-h shows the different embodiments of distal tip part 107.Although these design with Figure 11 a-b and 12a-b has some to be similar to, but here will discuss extra difference and feature.It is tuning firstly to Figure 16 a, distal tip is shown One embodiment of part 107, it include coiled arrangement staggered in cage set 404 (with the continuous spiral in Figure 11 a-b or Helix configuration contrast).The extra material that stay 411 is linked together can provide additional intensity, to resist and to use When can apply the external force to tip and internal power (such as twisting resistance or bending force).In a preferred embodiment, cage set 404 can be chemically etched, and be rolled onto cylinder by Nitinol sheet configuration.
Additionally, connector 402 here is provided with a multi-part connector discussing similar to Figure 14.Also can present including line 445 telltale mark.As previously discussed, this embodiment includes carrying indenting cutting part configuration on catheter shaft 302 High flexibility region 330.
Figure 16 b shows the similar embodiment carrying different high flexibility regions 330 on catheter shaft 302, and this is second highest Flexible region 330 is with snake design forming.
Turning now to Figure 16 c, this embodiment includes the high flexibility region 450 being integrated in distal tip part 107, And this other aspect of high flexibility region 450 is similar to the high flexibility region 330 shown in Figure 16 a, except region 450 herein is In distal tip part 107.This sentence the high flexibility region 450 made of snake cutting part configuration through connector 402 connect to Conduit shaft portion 105, and connect to cage set 404 via the second connector 430.Additionally, except high flexibility region shown herein 450, some applications may need to increase another extra high flexibility region 330 describing type before to catheter shaft 302.? In some situations, the inside that can cover region in high flexibility region and/or cage is provided with ptfe or the lining of other smooth polymer, So that stablizing the flexing minimum that line extends through finished product conduit.
Figure 16 d shows another enforcement of the distal tip part 107 similar to the embodiment described in Figure 16 c Scheme.Herein, high flexibility region 450 includes indenting design.
Figure 16 e shows an embodiment party of the distal tip part 107 similar to the embodiment illustrating in fig. 11 a Case, wherein cage set 404 includes coiled arrangement.Herein, the high flexibility region 330 on catheter shaft 302 includes overlapping not connecting Continuous straight cuts portion, each cutting part extends around an approximate semi-circumference of catheter shaft 302.These cutting parts can be similar in figure Configuration shown in 10c.Because these cutting parts are discontinuous, therefore lead to compare other high flexibility areas more as shown herein Field type, some embodiments in this high flexibility region 330 can have extra intensity.
Figure 16 f shows an embodiment of the distal tip part 107 including conical section.Herein, cage covers 404 warps Second connector 403 connects to conical section 452, and the diameter of this conical section 452 tapers into towards its near-end.Conical section 452 connect to catheter shaft 302 through connector 402, and can be provided with similar to the high flexibility region 330 being described above.Real at some Apply in scheme, conical section and/or cage set can be formed in the following way, i.e. using the rigid material through photochemical etching The sheet stock of material (such as Nitinol) is made spiral packaging thing to form (different metals or material however may also be employed).Should Some advantages of taper embodiment may include the smoother tracheascope service aisle that is moved through of conduit system 101 and move.
Figure 16 g shows another embodiment of the distal tip part 107 of the conical section different including.This Place, cage set 404 is formed as individual unit (with Figure 16 e contrast) in itself, and tapers into towards its proximate dimensional.In some situations In, the more than one piece of Figure 16 e that compares designs, and the manufacture of this cage Analysis of Nested Design of Figure 16 g and assembling are more cheap, and in some cases Can be by single Nitinol sheet material through photochemical etching, subsequent rolling shapes.This single-piece taper embodiment can also quilt So manufacture so that staggered coiled arrangement shown herein does not extend near as shown herein, so that this reality But the scheme of applying can be similar to the embodiment shown in Figure 16 f do not have the second connector 403.Preferably, cage set 404 use Connector 402 type described in above-mentioned Figure 14 is attached to conduit shaft portion 105.Such as Figure 16 f, high flexibility region 330 is (herein It is " indenting " type) can be presented on catheter shaft 302.
Figure 16 h shows one of cage set 404 used in some embodiments of distal tip part 107 not With configuration.Herein, cage set 404 is not spiral or helix configuration, but is formed with the intertexture configuration illustrating.This configuration is preferably Cut is formed, but different manufacture method (such as photochemistry milling) is also feasible.This embodiment party of cage set 404 The configuration of case requires in the application of extra flexibility to be favourable in distal tip part 107.In some configurations, for example work as cage When set 404 is constructed by Nitinol, using Nitinol compression ring, cage set 404 can be fixed to conduit shaft portion 105, rather than connect Connector type shown in part 402 or Figure 14.
Referring now to Figure 17, conduit system 101 can with for protecting conduit shaft portion 105 and distal tip part 107 Pipe 110 together encapsulates.May also provide valve loader 115, valve loader 115 is used for for valve or other medical treatment devices being loaded into far-end Tip portion 107., in us serial number 12/249,243 and 12/422, described in 179, this two for the example of this valve loader 115 Piece document is each all included herein.Using packaging 118, whole system 101 and valve loader 115 can be packaged together, and altogether With a whole set of assembly 120 of formation.
Figure 18 a shows a possible purposes of conduit system 101.Herein, conduit system 101 may be inserted into tracheascope 510 service aisle 511.Tracheascope 510 can be the tracheascope of commercially available model, the bf-p180 that such as olympus manufactures.Excellent Selection of land, except allow tracheascope be maneuvered into leading to the visual channel of the patient's trachea 601 of lung 600, this tracheascope be provided with to The service aisle of few 2.0mm.Certainly, except tracheascope, endoscope can be used for different operations, and these endoscopies preferably set There is at least service aisle of 2.0mm.The endoscope (inclusion tracheascope) used along with system 101 is preferably more than 110cm's Length.
Figure 18 b shows the alternative method using conduit system 101 together with tracheascope 510.Herein, as shown, clamp Portion 202 can be clamped in a part for tracheascope 510, and wherein tracheascope is received in the recess of clamping part 202.Clamping part 202 some embodiments may be structured to form c shape handle, and this handle can advantageously allow for the company more firm with tracheascope Connect.After clamping part 202 is fixed to tracheascope 510, conduit shaft portion 105 and distal tip part 107 are inserted tracheascope 510 Service aisle 511.In some embodiments it is advantageously that using tuohy-borst adapter 515, as shown at present. Because tuohy-borst adapter 515 helps fixing outer catheter sheath 316, during launching, the accurate placement of device does not need the Two people or other fixing meanss are pinching or to keep catheter sheath.
Figure 19 a-c shows an embodiment party of blocking mechanism used in some embodiments described herein The using and discharge of case.Figure 19 a presents the initial configuration of handle portion 103, and this system 101 is preferably subsequently provided to fill Carry valve therein or other medical treatment device.Herein, locking lever 210 in latched position, in this embodiment, send out by latched position Raw in locking lever 210 with respect to firm fin 208 to remote extension when.As shown in Figure 8 and above-described, work as lock Determine lever 210 when this position, be attached to the recess in the lock tab 222 and moveable handle 206 of locking lever 210 220 joints, thus reduce or eliminate the probability of moveable handle 206 movement.
Figure 19 b shows the system 101 in unblock (but not deployed) position.Herein, pass through with regard to pivot in this case Axle point 226 pivots locking lever 210, and locking lever 210 has been pushed to firm fin 208.When in this position, again With reference to Fig. 8, lock tab 222 pivots downwards or mobile, and departs from the recess 220 on moveable handle 206, therefore fair Permitted moveable handle 206 to slide axially towards clamping part 202 in near-end longitudinal direction.
After Figure 19 c shows that the device in being loaded in distal tip 107 launches, the configuration of handle portion 103.Herein, Movably handle 206 axially slides to or shifts to clamping part 202 on near-end longitudinal direction.Some embodiments can be arranged Locking lever 210 automatically resets to latched position.For example, the end of lock tab 222 is moved through in moveable handle 206 Afterwards, spring or other restoring force can promote or pivot locking lever 210 and return towards latched position, such as via being attached at The spring 228 (as shown in Figure 8) of lock tab 222 lower section.Correspondingly, if user distally return slip removable Dynamic handle 206, handle portion 203 will automatically reset the configuration shown in Figure 19 a, thus allows the exhibition of another device Open, remember reset lockout lever 210 without user.
Figure 20 a-c shows the conduit system 101 with the valve 500 in the chamber 405 being loaded in distal tip part 107 Embodiment.Notice that some structural details are shown in broken lines, or not shown for clarity purposes.Conduit system 101 have been inserted into tracheascope (not shown), and tracheascope is directed to the part of the requirement treatment of lung, is trachea in this case 601.
When determining the suitable expansion position (being represented) of valve 500 by expansion position 606 herein, operator can use line 445 The position being unfolded 606 is aligned by distal tip part 107 with valve, valve 500 can be from online 445 expressions of the far-end 410 of conduit Approximated position at discharge.In some embodiments, the airways region that line 445 substantially can be sealed against with valve 500 is aligned, because This can be aligned with expected expansion position 606.Line 446,447 positioned at line 445 side is preferably darker color, or uses Black colorant, to provide extra contrast, thus allow operator easily to see line 445 by tracheascope observation port.Again Person, in use, operator can make conduit extend distally beyond line 447, subsequently proximally withdraws conduit, until reaching line 445.When withdrawing, the First Line 447 running into is used as boundary mark, and instruction is closing on line 445.If so arranged, it is in The telltale mark 448 (as shown in Figure 15) of the length on the distal portions of conduit shaft portion 105 also can advantageously act as separately now One security feature, too remote to guarantee that conduit will not be extended beyond tracheascope by operator.
Online 445 with expected expansion position 606 to punctual, and locking lever 210 mobile to its unlocked position when, behaviour Moveable handle 206 is pulled to clamping part 202 (totally referring to Figure 19 a-c) by author in the proximal direction.This expansion is mobile to receive Return catheter shaft 302 and cage set 404, Simultaneous Stabilization line 304 keeps substantially static.In the pusher plunger 408 stablizing line 304 end Be preferably configured as contacting the center rod 502 of the valve 500 being inserted in chamber 405, thus keep valve 500 cage set 404 around Valve 500 is in basic same position when withdrawing.Through distal openings 410 after conduit discharges, the anchor extension of valve 500, from And contact with the wall of air flue 601, and valve 500 extends, so that the summit of its cup-like portion is totally selecting along lung qi pipe 601 Position 606 at come in contact.This method of deploying is useful, because by being aligned with line 445, it allows dress to be unfolded Put closely selected expansion position 606.Because distal tip part 107 withdraws around this device (such as valve 500), phase Relatively only from the device of the prior art of the far-end device for ejecting of conduit, this device in the present invention can more accurately be positioned And expansion.
Some embodiments of conduit system 101 also may conform to some benchmark and specification, with some situations and application Acceptably operate.For example, in the embodiment that system 101 is used for expansion valve in trachea, described above, The service aisle 511 of system 101 meeting partial insertion tracheascope 510.Because tracheascope 510 can the tortuous trachea through patient be inserted into With walk, system 101 therein allows for abundant flexing, and bears and will apply to its power, includes reversing, bends and kinking Power.Preferably, system 101 especially conduit shaft portion 105 is configured to balance following demand: needs firm enough Property, to transmit for making system 101 walk to the suitable power launching position, simultaneously sufficiently flexible, to travel through tortuous sky Between, and reduce the probability damaging or penetrating tracheal wall when extending through tracheascope service aisle.Additionally, system 101 is preferred Ground is designed such that, the possible inefficacy of any component stays in patient body all without by part.
Because system 101 would generally suffer from tension force or pulling force, therefore distal tip part 107 preferably in operation It is configured to remain attached to conduit shaft portion 105, to reduce or to eliminate some probabilities being partially left in patient body.Far End tip portion 107 preferably resists the kinking of cage set 404 or other components, and this can successfully convey and expansion is loaded in it In medical treatment device.
As shown in Figure 19 a-c and 20a-c, the embodiment of system 101 is preferably configured and makes in tracheascope Insertion and during the operation, and during the device being loaded into distal tip part 107 is launched, the constraint to movement for its component Minimum with resistance.The outside of conduit shaft portion 105 and distal tip part 107 is preferably configured to relative smooth, produces Minimum friction, so that these components slide in tracheascope service aisle freely.Additionally, stablizing line 304 and catheter shaft 302 and/or distal tip part 107 inside between friction be preferably also minimized.Preferably, it is used for overcoming and be loaded into far End tip 107 chamber 405 in the friction of device (such as valve 500) power should be less than as Figure 19 a-c and 20a-c discuss due to Development system 101 and pass through the power that handle portion 103 can apply.When configured in this manner, these embodiments can will fill Put smoother, be more accurately expanded to target site.
In use, the pulmonary of patient is inserted in tracheascope 510 by user, is treated from conduit system 101 expansion with using Device is treated.Subsequently, (device with such as valve 500, this device has been preinstalled and has been loaded into far-end end conduit system 101 In the chamber 405 of the tip 107) it is inserted into the service aisle 511 of tracheascope 510.Referring now to Figure 19 a-c, selecting and walking to suitable Expansion position after, locking lever 210 is moved into its unlocked position.
After confirming the position with regard to expansion position for the distal tip part 107, this may include expected expansion position It is aligned with any telltale mark such as line 445 (figure 15 illustrates), sliding cylinder 206 is slided to folder by user in the proximal direction Hold portion 202, thus the trachea in patient is in expansion position expansion medical treatment device (such as valve 500).
In some embodiments, the accuracy of pipe guide expansion can be improved in the following way: pinch or with it Outer sheath 316 on his mode A/C shaft portion, when catheter shaft 302 proximally withdraws, to be maintained at stablizing line 304 The position of geo-stationary.In preferred embodiments, conduit 101 can remove from tracheascope service aisle 511, and removable Dynamic handle 206 returns to its initial position, with another device of reloading.Therefore, repeatedly can be filled in patient's trachea Put expansion, remove from the pulmonary 600 of patient without by tracheascope 510.
It should be understood that the conduit system 101 that the expansion illustrating at present enters in lung is not restricted, and it should be understood that system 101 Can be used for for different device being deployed into patient's other positions, including stomach, endoscope or other correct position.Similarly, trachea Mirror is not required, and it is also possible to use being capable of receiving system 101 and can be directed to other of expanded position and properly fill Put, including but not limited to different endoscopies or laparoscopic insertion.
Although having disclosed the present invention, those skilled in the art under the description of some embodiments and embodiment It should be understood that the scope of the present invention not only covers specific embodiments disclosed, and also extend to other alternate embodiment and/or The purposes of the present invention and obvious remodeling and equivalent.In addition although being shown specifically and having described some of the present invention Modification, but on the basis of present disclosure, those skilled in the art are readily apparent that what other fell within the scope of the present invention Remodeling.Also it is envisioned that, combination or the sub-portfolio of the specific features to embodiment and aspect can be made, they still fall in the present invention In the range of.It should be understood that the different characteristic of disclosed embodiment and aspect can be mutually combined or replace, public herein to be formed The multi-form of the present invention opening or embodiment.As such, it is noted that the scope of present invention disclosed herein should not be by retouching above The specific embodiments disclosed stated limit.

Claims (17)

1. a kind of expansion conduit for a device being deployed into pulmonary, this expansion conduit includes:
Including the near-end of handle portion, described handle portion includes plunger, and this plunger is by moveable handle around described removable Dynamic handle is configured to axially upwardly slide at least one of side of the length along described plunger, and wherein said post Plug also includes the locking lever that can switch between locked and unlocked positions, and this locking lever is configured as described Prevent described moveable handle from sliding to described plunger in the proximal direction during latched position, but when in described unlocked position Allow described moveable handle to slide in the proximal direction, and wherein said locking lever is additionally configured to be reset to locking bit Put;
Conduit shaft portion, this conduit shaft portion includes the stable line within catheter shaft and described catheter shaft, wherein said catheter shaft It is fixed to described moveable handle in the proximal end of this catheter shaft, and wherein said line of stablizing is fixed to described plunger; And
Distal tip part, it is configured to receive in a chamber by a medical treatment device, wherein said distal tip part It is fixed to the far-end of the catheter shaft of hollow, and this distal tip part also includes receiving the propeller plunger in described chamber, Described propeller plunger connects to the described far-end stablizing line;
The plunger of wherein near-end also includes c shape handle in its near-end, and this c shape handle includes the opening for receiving endoscope.
2. expansion conduit according to claim 1, wherein said locking lever is attached in the far-end of moveable handle To plunger.
3. expansion conduit according to claim 1, wherein said locking lever includes being attached to the bullet of described locking lever Spring, this spring is configured to, after described medical treatment device launches from described expansion conduit, described locking lever be reset to Latched position.
4. expansion conduit according to claim 1, wherein said conduit shaft portion includes the high flexibility area positioned at its far-end Domain.
5. expansion conduit according to claim 4, wherein said high flexibility region is the construction of indenting form.
6. expansion conduit according to claim 4, wherein said high flexibility region is the construction of snake form.
7. expansion conduit according to claim 4, wherein said high flexibility region includes overlapping discontinuous straight cuts Portion.
8. expansion conduit according to claim 1, wherein said distal tip portion is divided including cage set, and this cage set is with least One is configured to receive the chamber of medical treatment device.
9. expansion conduit according to claim 8, wherein said cage tackling has the stay arrangement forming spiral structure.
10. expansion conduit according to claim 8, wherein said cage set includes one or more big fenestras.
11. expansion conduits according to claim 10, wherein said one or more big fenestras are configured to allow to see Examine and confirm described medical treatment device already loaded in described chamber.
12. expansion conduits according to claim 1, wherein said distal tip portion is divided including at least one telltale mark, Described telltale mark is configured to indicate the substantially expanded position of described medical treatment device.
13. expansion conduits according to claim 12, wherein said telltale mark is yellow, two extra black bands Positioned at both sides.
14. expansion conduits according to claim 1, the far-end of wherein said conduit shaft portion also includes at least one length Telltale mark.
15. expansion conduits according to claim 1, the strain that wherein said handle portion also includes a frustum of a cone disappears Except part, it is centered around around the proximal end region of described conduit shaft portion.
16. expansion conduits according to claim 1, also include an outer sheath, and it is at least about described conduit shaft portion Proximal end region.
17. expansion conduits according to claim 1, wherein said expansion conduit is configured to be loaded into a tracheascope.
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GB2511375A (en) 2014-09-03
DE112011105242B4 (en) 2024-04-25
CN106333749B (en) 2020-01-03
JP6026513B2 (en) 2016-11-16
CN202723895U (en) 2013-02-13
GB201318950D0 (en) 2013-12-11
GB2511375B (en) 2017-07-26
CN102970945A (en) 2013-03-13
DE112011105242T5 (en) 2014-03-06
WO2012158152A1 (en) 2012-11-22

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