CN102970945A - Deployment catheter - Google Patents

Deployment catheter Download PDF

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Publication number
CN102970945A
CN102970945A CN2011800024509A CN201180002450A CN102970945A CN 102970945 A CN102970945 A CN 102970945A CN 2011800024509 A CN2011800024509 A CN 2011800024509A CN 201180002450 A CN201180002450 A CN 201180002450A CN 102970945 A CN102970945 A CN 102970945A
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CN
China
Prior art keywords
catheter shaft
distal tip
handle
tracheascope
plunger
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2011800024509A
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Chinese (zh)
Inventor
D·奥康奈尔
E·利杰格伦
D·H·迪拉德
H·X·冈萨雷斯
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Spiration Inc
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Spiration Inc
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Publication date
Application filed by Spiration Inc filed Critical Spiration Inc
Priority to CN201610855500.2A priority Critical patent/CN106333749B/en
Publication of CN102970945A publication Critical patent/CN102970945A/en
Pending legal-status Critical Current

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    • 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
    • A61F2/962Instruments 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
    • A61F2/95Instruments 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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

A deployment catheter is described herein that preferably is configured to deliver a medical device such as a valve to a location in a patient such as a patient's airway. Preferably, such a deployment catheter is configured to be used in conjunction with a bronchoscope. In some embodiments, a locking lever is provided to reduce the likelihood of accidental deployment of the device, and which resets conveniently after use to as to permit multiple device deployments.

Description

Launch conduit
Background technology
Technical field
Embodiment of the present invention relate in general to field of medical devices, more specifically, relate to and utilize conduit to install--for example valve or other medical treatment device--mthods, systems and devices that launch and/or implant.
Description of Related Art
Sickness rate, popularity degree and the cost of pulmonary disease--for example COPD, chronic bronchitis and emphysema--all improving.New Therapeutic Method comprises that the lung that is undertaken by the non-surgery operation of selecting Wicresoft subtracts the appearance treatment.In these treatment situations, can the lung with the valve implant patient in, with size and/or the treatment gas leakage that reduces lung.Therefore need a kind of for safety and as one man will such valve or other medical treatment device implant patient trachea (airways) thus treat equipment and the method for pulmonary disease.
Summary of the invention
Each embodiment of the present invention relates in general to for via conduit medical treatment device (for example valve) being introduced body interior device, system and method.Conduit is a kind ofly to be inserted in the body or the pipe of body cavity, pipeline or vascular.Conduit can be used to allow fluid expulsion or be injected in the body, perhaps provides the path that enters in the body by surgical unit and/or implantable device.For implantable device is entered in the body, at first implantable device can be inserted in the conduit.For device being delivered to suitable position, the air flue in the lung for example, tracheascope or other devices can be provided with a service aisle, and described conduit can be introduced in this service aisle.Then can carry out conveying and expansion to being inserted in the device in the described conduit.In a preferred embodiment, the conduit that is mounted with valve is delivered to a position in the lung qi pipe with valve.
Use mthods, systems and devices described herein, valve or other medical treatment device (extensible or other forms of) can be introduced conduit or other expansion apparatus.Be loaded into after described conduit or other launch apparatus at described valve or other medical treatment device, can have used described conduit or other to launch apparatus described valve or other medical treatment device are implanted or be positioned in the patient body.Preferably, described valve or other medical treatment device are loaded into chamber or other space that arranges in the distal tip zone of described conduit or other expansion apparatus.In some embodiments, described conduit or other launch apparatus can be loaded into the service aisle of tracheascope or other this type of apparatus, and is walked (navigated) to suitable expanded position, for example patient's trachea.
The embodiment of described apparatus can have additional feature (alone or in combination), and these features can show advantage and the use aspect the help expansion.For example, a locking lever can be set, its reduction or elimination valve or the unexpected probability of launching of other device also can reset after launching, in order to repeatedly install expansion.In addition, a clamping part can be set, be C shape handle in certain embodiments, and it can be clipped in the tracheascope, launches to help valve or other medical treatment device, and an ergonomics handle also is set simultaneously.Also can telltale mark be set at this apparatus, especially at the far-end near apparatus, described telltale mark can help the operator that implantable device is aimed at selected expansion position.Distal tip partly also can be configured to the cage sleeve-like structure, and can be provided with one or more fenestras (fenestration), and described fenestra allows to observe and confirm that described valve or medical treatment device correctly are loaded in the distal tip.Certainly, this paper also will at length discuss other features and details.
In one embodiment, described for the expansion conduit that a device is launched pulmonary, wherein this expansion conduit comprises:
The near-end that comprises handle portion, described handle portion comprises a plunger, this plunger by one movably handle center on, described movably handle is configured to endwisely slip in the direction along at least a portion of the length of described plunger, and wherein said plunger also comprises the locking lever that can switch between locked, this locking lever is configured to when in described latched position, prevent that described movably handle from sliding to described plunger at proximal direction, but when at described unlocked position, allow described movably handle to slide at proximal direction, and wherein said locking lever also is configured to be reset to latched position;
Catheter shaft part, this catheter shaft partly comprise the stability line of catheter shaft and described catheter shaft inside, and wherein said catheter shaft is fixed to described movably handle in the proximal end of this catheter shaft, and wherein said stability line is fixed to described plunger; And
The distal tip part, it is configured to a medical treatment device is received in the chamber, wherein said distal tip partly is fixed to the far-end of the catheter shaft of described hollow, and described distal tip part also comprises the propeller plunger that is received in the described chamber, and described propeller plunger is connected to the far-end of described stability line.
Some embodiments provide the plunger that makes near-end to comprise C shape handle at its near-end.In some embodiments, described locking lever comprises and is configured to the lock tab that engages with recess in the described movably handle.Described locking lever also can comprise the spring that is attached to described locking lever, and this spring is configured to after described medical treatment device launches from described expansion conduit described locking lever be reset to latched position.
In some embodiments, described catheter shaft partly comprises high flexibility (flexibility) zone that is positioned at its far-end, and described high flexibility zone can comprise interlocking (jigsaw) structure, snake structure or overlapping straight cuts section.
Other embodiments provide and described distal tip portion are divided comprise the cage cover, and this cage cover is configured to receive the chamber of a medical treatment device with at least one.Described cage cover can have the stay that forms spiral structure to be arranged, and can comprise one or more large fenestras.In some embodiments, described one or more large fenestra is configured to allow to observe and confirm that described medical treatment device has been loaded in the described chamber.Described distal tip partly also can comprise at least one telltale mark, and described telltale mark is configured to indicate the roughly expanded position of described medical treatment device.In some embodiments, described telltale mark is yellow, and two extra black bands are positioned at both sides.In some embodiments, the far-end of described catheter shaft part also comprises the telltale mark that at least one is long.
In some embodiments, described handle portion also comprises the strain relief member of a frustum of a cone, and it is around the proximal end region of described catheter shaft part.Some embodiments also can comprise outer sheath, and it is at least around described catheter shaft proximal end region partly.Preferred embodiment can be configured to be loaded into a tracheascope.
Another embodiment provides a kind of a medical treatment device has been expanded to the method for patient pulmonary, and the method comprises:
Described medical treatment device is loaded into the chamber that is arranged in the distal tip part of launching conduit;
Described expansion conduit is introduced a tracheascope;
The lung qi pipe is inserted in described tracheascope;
Make described tracheascope walk part to be treated to the lung qi pipe;
The part to be treated of described lung qi pipe is aimed at at least one telltale mark on the distal tip part that is positioned at described expansion conduit;
The supravasal locking lever of the described expansion of release; And
Described medical treatment device is expanded to the part to be treated of described lung qi pipe.
In some embodiments, after described device launched, described locking lever reset to latched position.In other embodiments, described expansion conduit is included in the C shape handle of its near-end, and wherein said C shape handle is attached to the part of described tracheascope.In other embodiments, the step that described tracheascope is walked also comprises uses the radial imaging instrument to follow the trail of described expansion conduit.
Description of drawings
The accompanying drawing of each embodiment of hereinafter with reference is described aforementioned and other features, aspect and advantage of the present invention in detail, and described accompanying drawing is intended to illustrate and unrestricted the present invention.Described accompanying drawing comprises following each 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 shows respectively the top and bottom perspective views of an embodiment of the handle portion of conduit.
Fig. 5 A-B shows left view and the right view of an embodiment 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 feature sectional view of an embodiment of occlusion of catheter mechanism.
Fig. 9 A-B shows the close up view of skewer that catheter shaft is attached to an embodiment of modular catheter.
Figure 10 A-C shows the embodiment in the high flexibility zone that presents at catheter shaft.
Figure 11 A-B shows respectively the close up view of embodiment of distal tip that does not wherein load valve and wherein be mounted with the conduit of valve.
Figure 12 A-B shows respectively the feature sectional view of embodiment of distal tip that does not wherein load valve and wherein be mounted with the conduit of valve.
Figure 13 is the close up view of distal-most end of distal tip of an embodiment of conduit.
Figure 14 shows the embodiment that can be used for distal tip is attached to the connector mechanism of catheter shaft.
Figure 15 shows the close up view of distal tip of the embodiment of the catheter shaft that is added with the localizer labelling.
Figure 16 A-H shows the different embodiments of the distal tip of conduit.
Figure 17 is the conduit of encapsulation and the view of the embodiment of valve loader system.
Figure 18 A shows the embodiment of the conduit that is loaded into the tracheascope of inserting the lung qi pipe.
Figure 18 B shows the embodiment with the conduit of the clamping part that is attached to tracheascope.
How the blocking mechanism that Figure 19 A-C shows in the embodiment that is presented on modular catheter operates.
Figure 20 A-C shows and uses the valve of an embodiment that is loaded into conduit that valve is launched air inlet pipe.
Specific embodiments
Associated components and the parts of conduit development system and system are described referring now to the accompanying drawing of one or more embodiments.The term that uses in the description that provides herein is not intended to be explained with any limitation or ways to restrain.On the contrary, only the detailed description of the embodiment of coupling system, method and associated components is used term.In addition, each embodiment can comprise some New Characteristics, and the single feature in these features is not made separately the contribution of expection, or should not think that single feature is for realizing that invention described herein is absolutely necessary.
Term used herein " valve (valve) ", " extensible medical treatment device (deployablemedical device) ", " medical treatment device (medical device) " and " device (device) " is the interchangeable terms of broad sense, unless point out in addition, in its implication, described term can comprise support without limitation, valve, lung subtracts the appearance valve, air bag, probe, labelling (comprising radiopaque labelling and other forms of reference mark), anchor, or any other is configured to load or introduce conduit or other medical treatment device (deployable or other forms of) that launches apparatus and be transferred subsequently or launch.Although embodiments more described herein are for being deployed into medical treatment device in the trachea, present disclosure is not limited to this, but is deployed to other vasculars, path and body cavity such as but not limited to humans and animals.In certain embodiments, described valve and/or medical treatment device are at United States Patent (USP) the 6th, 293, No. 951 or the 7th, 757, and disclosed type in No. 692, described two pieces of patents are all included this paper separately in.
Fig. 1 shows an embodiment launching conduit system 101.This system 101 comprises some coefficient different pieces.The near-end of system 101 comprises handle portion 103, and this handle portion is attached to catheter shaft part 105, and catheter shaft part 105 ends at the distal tip part 107 of system's 101 far-ends.In a preferred embodiment, proximal handle part 103 is connected to distal tip part 107 through described duct portion 105, and described distal tip part 107 preferably comprises the medical treatment device of use system 101 proper site to be extended to.In some embodiments, distal tip part 107 can comprise (or be configured to receive) for example device of the valve in the trachea path to be deployed in.
Fig. 2-5 shows other external views of handle portion 103.Handle portion 103 preferably is suitable for user to be held or grips, and comprises some parts.Handle portion 103 comprises the clamping part 202 that is connected to plunger 204.Movably handle 206 is attached to plunger 204, for example can arrange around plunger 204.Catheter shaft part 105 is connected to handle portion 103 at the far-end of handle portion 103.
The clamping part 202 of handle portion 103 can be constructed to recess, and when the device that prepare to launch to be included in the distal tip part 107, this recess can allow the thumb of user to hold or catch handle portion 103.As shown, clamping part 202 can form C clamp and hold section.Clamping part 202 can adopt other shapes, such as but not limited to, clamping part 202 can have the inner surface of U-shaped, V-arrangement or depression.In some embodiments, following texts and pictures 18B describes in further detail, and clamping part 202 can be attached to a device, and for example endoscope perhaps more specifically is attached to tracheascope.The clamping part that holds or operate 202 that is available for users to and the miscellaneous part of system 101 can be provided with coating anti-skidding or rubber processing, so that extra grip to be provided to user.
Clamping part 202 is attached to plunger 204.Plunger 204 can be provided with the embossing 205 of ergonomics finger, and when operating system 101, the finger that the embossing 205 of ergonomics finger can be user provides more firm or comfortable gripping.
Movably handle 206 is constructed to engage with plunger 204 movably, so that movably handle 206 for example can vertically slide before and after the axial direction along at least a portion of plunger 204.From the position shown in Fig. 2, movably handle 206 can be shifted to clamping part 202 at proximal direction.
At the far-end of handle 206 movably, firm fin (securement tab) 208 and locking lever 210 can be attached to plunger 204.Locking lever 210 is configured to when in the latched position that illustrates, and it engages with handle 206 movably, to reduce or to eliminate handle 206 is movably shifted to clamping part 202 at proximal direction probability.Movably handle 206 preferably includes the ergonomics adminicle--and for example ridge 207, and it is so that user is launching can easily to operate and spur movably handle 206 during the medical treatment device.In some embodiments, movably all parts of handle 206 or a part can be provided with coating anti-skidding or rubber processing, so that extra grip to be provided to user.
Handle portion 103 also can comprise strain relief member 212.Preferably, this strain relief member 212 is attached to handle portion 103, and is made by following elastomeric material, polymer for example, comprise (such as but not limited to) rubber, thermoplastic elastomer (TPE) (Santoprene for example TM,
Figure BDA0000120526840000071
), polyurethane, polrvinyl chloride,
Figure BDA0000120526840000072
And siloxanes.The shape of strain relief member 212 can be approximate circle taper or conical butt, and with the central opening of longitudinal extension, this central opening is configured to fit tightly with outer sheath 316 (if being provided with) or the catheter shaft 302 of catheter shaft part 105.Strain relief member 212 can reduce by 105 kinkings of catheter shaft part or crooked probability near the abutment of catheter shaft part 105 and handle portion 103, especially when catheter shaft part 105 is inserted into instrument (for example tracheascope), and when in use being operated.
Refer now to Fig. 6, it illustrates the sectional view of catheter shaft part 105.Catheter shaft 302 is hollow, and is included in the wherein stability line 304 of longitudinal extension.Catheter shaft 302 is preferably by elasticity and durable (robust) material structure (for example a kind of metal or various metals), described material stretch-proof and plastic deformation, keep simultaneously enough flexibilities, to be conducted through zigzag channel and other similar converging ducts.Suitable metal can comprise rustless steel, Nitinol (Nitinol) etc.In some embodiments, polymer pipe respond well, some embodiments for example can be by continuous polymer-extruded manufacturing.These are extruded and also can comprise and interweave to obtain extra intensity and ruggedness, and can be by polymer--for example polyimides--structure.Stability line 304 can be constructed by similar material equally.
In some embodiments, smooth coating or material can be added in stability line 304 or the catheter shaft 302 one or both, and this can help these two parts more mutually to slide through freely, and totally do not have and block or sticking card.For example, polymer (for example PTFE or Parylene) can be applied on the stability line 304.Coating (for example FEP) also can be extruded into stability line.Thermal polycondensation compound (for example PTFE or polyethylene) also can be added into stability line 304.
In some embodiments, preferably, described stability line 304 can be along the vicissitudinous diameter of its length tool.This diameter for example can be continuously or the mode that reduces gradually change, perhaps change in stepwise (stepwise) mode.In the situation of not wishing to be bound by theory, we think that the following embodiment of stability line 304 is favourable, that is, has larger diameter at near-end (namely towards handle portion 103), to reduce or to eliminate in the probability that applies flexing in the situation of higher load; Has less diameter towards far-end (namely near tip part 107) simultaneously, so that extra flexibility to be provided.In one embodiment, stability line 304 begins to have 0.020 inch diameter from near-end always, until be similar to 1 inch just variation by outer sheath 316.The diameter stepwise of the remainder of stability line 304 is changed to 0.016 inch.This embodiment can be used in the catheter shaft 302 of internal diameter for approximate 0.022-0.024 inch, so that the gap on each side is approximate 0.001-0.002 inch at near-end between catheter shaft 302 and the stability line 304, far-end is 0.003 inch.
With reference to figure 7, it shows the sectional view of handle portion 103.Fig. 8 shows the close up view of this sectional view.In a preferred embodiment, clamping part 202 is connected to stability line 304, although in some embodiments, stability line 304 also can be connected to plunger 204, perhaps alternatively is connected to plunger 204.Stability line 304 is disposed in the catheter shaft 302, and catheter shaft 302 preferably is configured to slide about stability line 304 in a longitudinal direction.
In certain embodiments, crimp tube 305 is used for stability line 304 is connected to clamping part 202.Crimp tube 305 is preferably by the metal construction harder than stability line 304, stainless steel alloy (for example SS304) for example, and form hypotube (hypotube).Preferably, crimp tube 305 is crimped onto the near-end of stability line 304, and the near-end of crimp tube 305 is maintained at clamping part 202 inside, and the far-end of crimp tube 305 is maintained in the remainder of main body of plunger 204.In some embodiments, crimp tube 305 can partly extend on the catheter shaft 302, for example extends 0.1 inch short length, because when power is applied to catheter shaft 302, this can be catheter shaft 302 extra anti-flexibility is provided.In some embodiments, crimp tube 305 can have approximate 0.039 inch internal diameter, 0.010 inch of wall thickness.
Catheter shaft 302 is connected to movably handle 206 through a skewer 216.Because movably handle 206 preferably is configured to slide along plunger 204 front and back, and because movably handle 206 is attached to catheter shaft 302, so movably the movement of handle 206 can cause catheter shaft 302 with respect to the corresponding movement of stability line 304.As discussed below, this moves the device that allows to be contained in distal tip 107 and ejects and expansion.In addition, locking lever 210 can be provided with a lock tab 222, and this lock tab 222 engages with recess 220 on the handle 206 movably, thereby helps to reduce or eliminate the probability that handle 206 movably slides along plunger 204.This set can be used for help reducing or eliminates unexpected or prematurely from conduit system 101 expanding units.In certain embodiments, catheter shaft 302 alternately is connected to plunger 204, and stability line 304 can be connected to movably handle 206 through described skewer 216.
Catheter shaft 302 preferably is fixed to handle portion 103, and in certain embodiments, one or more intermediate members can form the part of this connection.In some embodiments, refer now to Fig. 9 A-B, catheter shaft 302 can be fixed to the fork-shaped intermediate member, and for example skewer 216, and catheter shaft 302 for example can be clamped in the recess of fork-shaped intermediate member.Skewer 216 itself is connected to again movably handle 206.For clear, omitted movably handle 206, but movably handle 206 can be found out in Fig. 7-8 with the relation of miscellaneous part.
Skewer 216 preferably includes at least two prongs 217.These prongs 217 have an interval each other, and this interval is less than the diameter of catheter shaft 302.For catheter shaft 302 is connected to skewer 216, catheter shaft 302 (preferably being configured with circular cross section) can have one or more breach or the chamber 308 that forms thus thereon.Described breach or chamber 308 allow catheter shaft 302 is received in two intervals between the prong 217, this is because chamber 308 will cause catheter shaft 302 to have a segment distance of less cross section along the distance of catheter shaft 302, inserts and is fixed in two intervals between the skewer 217 to allow catheter shaft 302.Correspondingly, can form axial restraint between catheter shaft 302 and skewer 216 connects.Therefore because stability line 304 is positioned at catheter shaft 302, must be noted that breach or chamber 308,310 do not interfere in fact relatively moving freely of catheter shaft 304, or do not cut into catheter shaft 304.
Test demonstrates, and the skewer 216 (skewer 216 can by any suitable constructed of rigid materials, for example comprise stainless metal) by the rustless steel structure of an embodiment can bear the power greater than 20 pounds before losing efficacy.Therefore because user can not apply large like this power during launching, this structure is so that system 101 more may remain intact, and the inefficacy of skewer 216 unlikely causes catheter shaft 302 to separate with the remainder of system 101.
Again with reference to figure 1, also can outer sheath 316 be set in catheter shaft part 105.Outer sheath 316 can be between catheter shaft 302 and strain relief member 212, and can be used for (with strain relief member 212, if be provided with strain relief member 212) kinking of duct portion 105 and torsional load are minimized.For guaranteeing the reliable connection of sheath 316, preferably sheath 316 is fixed to plunger 204, for example by insert moulding (insert molding) or binding agent.In some embodiments, the outer sheath size between 22 to 39 inches, wall thickness between approximate 0.005-0.015 inch, preferably 0.010 inch.Preferably, outer sheath 316 has space or gap between itself and catheter shaft 302.In some embodiments, the size in this gap is between about 0.003-0.010 inch, and preferably each side is 0.005 inch.Be configured in the embodiment of aseptic (for example using the eo sterilization method) at some, the gap between catheter shaft 302 and the outer sheath 316 can be designed to allow fully flowing of antibacterial between two parts.
Outer sheath 316 is preferably by following material structure, comprises the polymer that for example forms with single polymer-extruded (single polymer extrusion), for example HDPE, PA-12, Polyurethane, the perhaps mixture of above material.In some embodiments, outer sheath 316 is formed by two kinds of different materials co-extrusions.Externally sheath 316 can use lubricious material towards a side of catheter shaft 302, for example HDPE, FEP, or other suitable material.In the outside of sheath 316, can use polymer--for example
Figure BDA0000120526840000102
Or PA-12 or other suitable material--obtaining the balance between following each factor, described factor such as can promote ability (for example limiting the amount of the power that user can apply), mechanical strength (for example non-deformability under load), bending resistance folding endurance, with friction and the manufacturability of tracheascope inside.In some embodiments, ray thoroughly material (for example barium sulfate) can be included into other elements of sheath 316 and/or conduit system 101.
With reference to figure 10A-C, can be along a series of cutting parts of all or part of formation of the cardinal principle of catheter shaft 302.These cutting parts can limit one or more flexible zones 330 that increase, and zone 330 usually can be than remaining uncut catheter shaft 302 better bending or warpage.In some embodiments, have been found that if the part of the far-end of catheter shaft 302 has the high flexibility zone 330 of cutting wherein, then conduit system 101 puts up a good show, and this is because the distal portions of catheter shaft 302 needs greatly bending, to pass through for example tortuous trachea path.The flexibility in high flexibility zone 330 can be designed according to the requirement of concrete application.For example change flexibility by interval, pitch (pitch) and angle between the cutting part in thickness, use therein material and the high flexibility zone 330 of revising catheter shaft 302.Preferably, cutting part extends in a spiral manner along catheter shaft 302.
In addition, high flexibility zone 330 needs not be the single pitch shown in Figure 10 A, but with reference to figure 10B, high flexibility zone 330 alternatively can be variable pitch, and wherein interval or pitch can change or the stepwise variation continuously.In addition, although can make continuous single cutting part at the cutting part shown in these figure, can use one or more discontinuous cutting parts to make the high flexibility zone.In these figure, the cutting part that consists of high flexibility zone 330 is made with " interlocking " configuration that forms sawtooth or zigzag pattern.Other feasible cutting parts are that following texts and pictures 16B and C illustrate and discuss " snake (serpentine) " configuration.In this snake configuration, cutting part is more smooth, round than indenting pattern, and has long amplitude.Other cutting part types are also feasible and can imagine, and comprise straight cuts section, part or dotted line cutting part, in a zigzag cutting part, sinusoid cutting part etc.
Figure 10 C shows an embodiment in the high flexibility zone 330 that comprises overlapping discontinuous straight cuts section, half extension of the approximate circumference around catheter shaft 302 of each cutting part.In this embodiment, punching 331 can be arranged on one or more ends of each cutting part.In some cases, punching 331 can be used as for generation of the part of the laser cutting parameter of cutting part and makes, but these cutting parts can use any suitable technique manufacturing, for example chemical etching.Punching 331 also can be used for guide tubular axis 302 provides extra intensity, and this is can help to reduce or eliminate the probability of cracks can spread when the different stress of catheter shaft 302 experience because believe punching 331.
In practice, high flexibility zone 330 and consist of that the processing of the cutting part in this high flexibility zone 330 can be such as expectation between the flexibility that requires and cutting part type, find appropriate balance.For example, although wider or larger cutting part can provide extra flexibility, these can weaken catheter shaft 302 to unacceptable degree in some cases.Different cutting part types also can more or less be worked in fatigue test satisfactorily.In addition, some cutting part can cause the service aisle of the part wearing and tearing tracheascope in high flexibility zone 330, but the post-treatment after cutting part produces can comprise for example deburring that can partly alleviate at least this misgivings or the step of ultrasonic waves for cleaning.Above-described cutting part type also can be adjusted according to the length in one or more high flexibilities zone 330.
In preferred embodiments, have been found that size can effectively work in 3 to 6 inches high flexibility zone 330 (pitch between the cutting part is between 0.010 to 0.100 inch).Having been found that in some embodiments, is gratifying in the scope of cutting part width (joint-cutting) between the 0.0015-0.0030 inch.
In certain embodiments,--for example polymer or heat-shrinkage material--covers high flexibility zone 330 at least can preferably to adopt the flexible protective layer.This protective layer can at least part of minimizing because the wearing and tearing of the service aisle inside of the tracheascope that cutting part causes, and also can reduce or eliminate the probability of catheter shaft 302 damages or excess elongation, this can help so that conduit can be used for repeatedly launching.In addition, this protective layer can also be smooth or lubricated, thereby allows catheter shaft 302 more easily to slide in the tracheascope service aisle.
Refer now to Figure 11 A-B and 12A-B, distal tip part 107 can be engaged to catheter shaft part 105 through connector 402.More specifically, in some embodiments, connector 402 is connected to distal tip part 107 with outer catheter axle 302.In preferred embodiments, distal tip part 107 can comprise cage cover 404, and this cage cover 404 is connected to catheter shaft 302 through connector 402.This cage cover 404 can by one or more enough durable material make, described material comprises metal, for example rustless steel and Nitinol.In some embodiments, cage cover 404 can be by preformed tubing structure, and some other embodiment can have the cage cover 404 by the flat structure of material, and described material is wound in longitudinal direction or the hand of spiral subsequently and forms pipe.
Distal tip part 107 preferably is configured to comprise chamber 405 in the inner, position, and the size in chamber 405 is configured to receive suitable device subsequently to be unfolded.Preferably, cage cover 404 comprises and is positioned at the chamber 405 that cage overlaps 404 inner spaces.
In some embodiments, illustrate such as Figure 11 B and 12B, chamber 405 can hold medical treatment device, and for example valve 500.In some cases, use in US serial number 12/249,243 and 12/422, the valve loader of type described in 179 can be loaded into chamber 405 with valve 500 by distal openings 410, described US serial number 12/249,243 and 12/422,179 includes in full this paper in separately at this.In case be loaded into chamber 405, the proximal end in abutment of device (for example valve 500) is against propeller plunger 408, propeller plunger 408 then be connected to stability line 304.In use, movably handle 206 moves about the near-end of plunger 204 in handle portion 103, causes cage cover 404 to be retracted with respect to propeller plunger 408, thereby discharges the device (for example valve 500) that is contained in the chamber 405 from opening 410.
Fenestra 409 is preferably located at least a portion of cage cover 404, and the flexibility that can be used for improving the visuality that is positioned at device wherein and improve distal tip part 107.Remaining stay 411 forms cage cover or tower structure, and can comprise spiral or interlaced helical pattern, and however different configurations and pattern also are feasible.Fenestra 409 for example can be by cut.Also can utilize other method, for example photochemistry milling.
Preferably, cage cover 404 also comprises one or more large fenestras 413.This large fenestra 413 is conducive to observe the device that is positioned at chamber 405, and confirms that device suitably or correctly is loaded in the chamber 405.Large fenestra 413 also can be used for providing one for the clear area of telltale mark band or other telltale mark (hereinafter discussing in detail).Preferably, whole cage cover 404 is constructed by single piece of material, and comprises that the distal portions of the cage cover 404 at edge 415 can be connected to through vertical stay 414 proximal part of cage cover 404.
In the manufacturing of distal tip part 107, advantageously coated distal end tip part 107 and cage overlap 404 interior section and/or exterior section.For example, apply softer material (for example polymer) and can effectively avoid when using conduit systemic injury, and help distal tip part 107 in the service aisle of tracheascope or Other Instruments, freely to slide.In addition, the interior section that applies conduit can help to reduce or eliminate being loaded in the destruction of medical treatment device wherein, perhaps reduces or eliminate the probability of obstruction medical treatment device expansion.
Therefore, some embodiment provides lining at least a portion of the inner surface that is positioned at cage cover 404 or chamber 405 (--for example politef--forms for example by polymer), in conjunction with the lining on the outer surface that is positioned at least distal tip 107 parts (can be by polymer--for example
Figure BDA0000120526840000131
--form).
In some embodiments, but these coating or lining soft heat (reflowed) to distal tip part 107.Use axle, can apply heat with these lining soft heats on the metal part of far-end 302.Preferably, selected lining is about fenestra 409,413 at least part of transparent, so that can check loading medical treatment device wherein.Different piece along distal tip 107, can use different polymer and polymer type, wherein for example only use transparent polymer along a part of distal tip 107, and use opaque or coloured polymer along a different piece of distal tip 107, to allow that conduit is processed into application and the purposes of expection specially.As hereinafter with among Figure 15 discussing, these polymer coatings and soft heat also can be incorporated in telltale mark on the distal tip part 107 or in the distal tip part 107.Useful diverse ways makes distal tip part 107 coating, comprises immersion coating, pushes, applies heat-shrinkage material etc.
In a preferred embodiment, be configured to around the edge 415 of opening 410 that is positioned at distal tip part 107 far-ends smooth and atraumatic, to reduce or to eliminate when inserting and launching to be arranged in the device in chamber 405 probability to systemic damage.
Preferably, with reference to Figure 13, edge 415 comprises a series of little weld part (welds) around opening 410 circumferential arrangement, and described weld part for example can adopt laser weld to make, so that smooth, rounded ends to be provided.In this case, edge 415 can be configured to provide atraumatic tip thus, and this tip is so that minimum to obstruction or other clampings of 405 devices that launch from the chamber, simultaneously also so that it is durable and can support multiple use.In other embodiments, edge 415 can be aggregated thing or the covering of other soft material layer.
Now again with reference to figure 11A-B and 12A-B, in some embodiments, via the far-end of cage cover 404 or catheter shaft 302, connector 402 can be along the border that connector 402 is engaged to distal tip part 107 by roll welding (seam-welded).This welding is preferred, because it provides the more smooth transition from catheter shaft part 105 to distal tip part 107, has reduced thus operator's operation easier, and helps to provide the movement of the smooth and continuous of system 101 during launching.Also can use spot welding, but should note reducing the size of spot welding, prevent from excessively giving prominence to, this is because the danger that exists this weld part to block in tracheascope or hinder.
With reference to Figure 14, some embodiment provides the connector 402 by the multi-part design structure.In these embodiments, compression circular cone 430 for example is attached to the far-end of outer conduit axle 302 by welding.Lasso (ferrule) 432 is for example by welding or being attached to far-end 402 by mechanical interlocking simply, and lasso 432 can be pushed subsequently crosses compression circular cone 430, is clipped in the middle with the near-end with cage cover 404.This interlocking connects and comprises connector 402, and forms the strong connection that can resist most pulling force.Specimen can be born at least pulling force of 100N.
Now forward Figure 15 to, an embodiment of system 101 can be provided with telltale mark.These telltale marks for example can be arranged on the part of far-end of distal tip part 107 and catheter shaft part 105.Usually, telltale mark helps the operator to determine that system 101 is about the position of external object.Telltale mark can be visual, is useful at the visibility constrained environment in--field of view scope of for example seeing by tracheascope--therefore.More specifically, telltale mark can help to select and indicate suitable expansion position for the medical treatment device that is loaded in the conduit, and is used for allowing the operator to determine that whether conduit extends too far away from service aisle or other conveyer device of tracheascope.
Some embodiment can be provided with one or more telltale marks, and line 445,446,447 for example, these telltale marks can help to select and indicate suitable expansion position for the medical treatment device that is loaded in the conduit.Herein, when the conduit that accommodates device is loaded into tracheascope, and when being directed to the part (for example lung qi pipe) of the health that requires treatment, the operator can use line 445 position that conduit and medical treatment device is to be unfolded to aim at, because the apparent position that line 445 can indicate medical treatment device to discharge from opening 410.In some embodiments, device can be the valve 500 that launches in trachea, and in these cases, line 445 films common and valve 500 will seal the air flue regional alignment that props up.These embodiments hereinafter and Figure 20 A-C describe in further detail.
Line 445 can be particularly advantageous in and help to observe passage by tracheascope and see suitable expansion position, and some embodiments so that line 445 by other black or have different contrasts color belts 446,447 around or be clipped in the middle, so that extra contrast to be provided.--for example bat printing or ink jet printing--is marked at distal tip part 107 with line 445, considers biocompatibility although can adopt suitable means, sometimes must make line 445 not adopt the pigment of exposure in its structure.In these cases, some embodiments can be used the indicia band of arranging around distal tip part 107.These indicia band can be comprised of polymer belt, for example by heat-shrinkable polymer--and for example
Figure BDA0000120526840000151
--structure.Owing to have been found that yellow line 445 is favourable in some applications, therefore golden indicia band can be enclosed within on the distal tip part 107.Indicia band can be made of any suitable material, and preferably the material by highly-visible consists of.Have been found that the gold that for example is mixed with iridium or the material of platinum are acceptable materials.Optionally, can be encapsulated in the lining below of describing in above the softening-melting process as the indicia band of line 445, perhaps be encapsulated in one other and preferably at least part of transparent polymer is (for example
Figure BDA0000120526840000152
) layer below.
In some embodiments, can be by a row or a series of fenestra be cut into distal tip part 107 formation line 445 or other telltale marks, so that do not need extra material to form corresponding telltale mark.In addition, although above-described line 445 is positioned on the distal tip part 107, other embodiments can place line 445 other parts of system 101.For example, line 445 can on stability line 304 or plunger 408, wherein if necessary, can advance with the cutting that is associated aperture or the fenestra of distal tip part 107, to allow to see line 445.
In addition, some embodiment can arrange long telltale mark 448, for example is positioned at the distal portions of catheter shaft 105.This long telltale mark 448 can be used the cautionary characteristic of doing the operator, and it is too far away that warning conduit system 101 has extended through tracheascope.This long telltale mark 448 is preferably painted or coloured, for example be contrast color (for example yellow), with easily when conduit will extend through tracheascope the person of being operated see.Can use any suitable means (describe before comprising be used for line 445,446,447 means) that long telltale mark 448 is placed catheter shaft 105.Preferably, long telltale mark 448 can be by suitable thermal contraction polymer architecture, and in some cases, this polymer can be covered by pure or colourless protection polymeric layer subsequently.In some embodiments, the size of long telltale mark 448 can be preferably 6 inches between 5 to 10 inches, and can be positioned at apart from approximate 2 inchs of distal tip.
Although telltale mark discussed above mainly refers to visual indicant, the telltale mark that uses in the system 101 also can be configured to use other means location.For example, any telltale mark or line 445,446,447,448 can be constructed by radiopaque material (for example barium sulfate), or include radiopaque material (for example barium sulfate), in order to locate with the radial imaging method.In the embodiment of the MRI of system 101 compatibility, the MRI contrast medium also can be incorporated into telltale mark.Active (being provided power) or passive (for example passive RFID) witness marker lamp (beacon) also can be incorporated into distal tip part 107, described witness marker lamp can together work with above-mentioned telltale mark, or alternative 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 do not need requirement visual confirmation distal tip part 107 with respect to the position of launching the position.These telltale marks are also in conjunction with the mixed positioning labelling of multiple localization method, for example not only ray not thoroughly, but also visual telltale mark.
Figure 16 A-H shows the different embodiments of distal tip part 107.Although these designs have some similar with Figure 11 A-B and 12A-B, at this extra difference and feature will be discussed.At first forward Figure 16 A to, an embodiment of distal tip part 107 is shown, it comprises coiled arrangement staggered in the cage cover 404 (with continuous spiral or the helix configuration contrast among Figure 11 A-B).The extra material that stay 411 is linked together can provide additional intensity, resists external force and the internal forces (for example twisting resistance or bending force) that can be applied in use tip.In a preferred embodiment, cage cover 404 can by Nitinol sheet material structure, by chemical etching, and be rolled onto cylindrical.
In addition, connector 402 is provided with one at this and is similar to the multi-part connector that Figure 14 discusses.Also can present the telltale mark that comprises line 445.As previously discussed, this embodiment comprises on the catheter shaft 302 the high flexibility zone 330 with the cutting part configuration of interlocking.
Figure 16 B shows on catheter shaft 302 the similar embodiment with different high flexibility zones 330, and current high flexibility zone 330 is with the snake design forming.
Now go to Figure 16 C, this embodiment comprises the high flexibility zone 450 that is integrated on the distal tip part 107, and 450 other aspects, this high flexibility zone are similar to the high flexibility zone 330 shown in Figure 16 A, except herein zone 450 is on distal tip part 107.This sentences the high flexibility zone 450 that snake cutting part configuration makes and is connected to catheter shaft part 105 through connector 402, and is connected to cage cover 404 via the second connector 430.In addition, except the high flexibility zone 450 that illustrates herein, some application may need guide tubular axis 302 to increase another extra high flexibility zone 330 of describing type before.In some cases, can be in the high flexibility zone and/or the inside in cage cover zone be provided with the lining of PTFE or other smooth polymer minimum so that stability line extends through the flexing of finished product conduit.
Figure 16 D shows another embodiment of the distal tip part 107 that is similar to the embodiment of describing in Figure 16 C.Herein, high flexibility zone 450 comprises indenting design.
Figure 16 E shows an embodiment that is similar in the distal tip part 107 of the embodiment shown in Figure 11 A, and wherein cage cover 404 comprises coiled arrangement.Herein, be positioned at high flexibility zone 330 on the catheter shaft 302 and comprise overlapping discontinuous straight cuts section, each cutting part is around approximate half circumferential extension of catheter shaft 302.These cutting parts can be similar in the configuration shown in Figure 10 C.Because these cutting parts are discontinuous, other high flexibility area types shown in this paper that therefore cause comparing, some embodiments in this high flexibility zone 330 can have extra intensity.
Figure 16 F shows an embodiment of the distal tip part 107 that comprises tapering part.Herein, cage cover 404 is connected to tapering part 452 through the second connector 403, and the diameter of this tapering part 452 diminishes gradually towards its near-end.Tapering part 452 is connected to catheter shaft 302 through connector 402, and can be provided with the high flexibility zone 330 that is similar to the preamble description.In some embodiments, tapering part and/or cage cover can form in the following way, that is, use is made the spiral packaging thing through the sheet stock of the rigid material (for example Nitinol) of photochemical etching and is formed (however also can adopt different metals or material).Some advantages of this taper embodiment can comprise that the conduit system 101 more level and smooth tracheascope service aisles that move through move.
Figure 16 G shows another embodiment of the distal tip part 107 that comprises a different tapering part.Herein, cage cover 404 itself forms individual unit (with Figure 16 E contrast), and diminishes gradually towards its near-end size.In some cases, many designs of Figure 16 E that compares, the manufacturing 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, and subsequently rolling is shaped.This single-piece taper embodiment can also be made like this, so that the staggered coiled arrangement that illustrates is not extended closely as illustrating herein, so that can being similar to the embodiment shown in Figure 16 F, this embodiment do not have the second connector 403 herein.Preferably, cage cover 404 uses connector 402 types of describing among above-mentioned Figure 14 to be attached to catheter shaft part 105.As Figure 16 F, high flexibility zone 330 (being " interlocking " type) can be presented on the catheter shaft 302 herein.
Figure 16 H shows a different configuration of the cage cover 404 that can use in some embodiment of distal tip part 107.Herein, cage cover 404 is not spiral or helix configuration, but forms with the configuration that interweaves that illustrates.The preferred cut of this configuration forms, but different manufacture methods (for example photochemistry milling) also is feasible.This embodiment of cage cover 404 to be configured in the application that distal tip part 107 requires extra flexibility be favourable.In some configurations, for example when cage cover 404 construct by Nitinol, can use the Nitinol compression ring that cage is overlapped 404 and be fixed to catheter shaft part 105, rather than the connector type shown in connector 402 or Figure 14.
Refer now to Figure 17, conduit system 101 can together encapsulate with the pipe 110 for the protection of catheter shaft part 105 and distal tip part 107.Also can provide valve loader 115, valve loader 115 is used for valve or other medical treatment devices are loaded into distal tip part 107.The example of this valve loader 115 is described in US serial number 12/249,243 and 12/422,179, and these two pieces of documents are all included this paper separately in.Can use packing 118 that whole system 101 and valve loader 115 are packaged together, and jointly form a whole set of assembly 120.
Figure 18 A shows a possibility purposes of conduit system 101.Herein, conduit system 101 can be inserted the service aisle 511 of tracheascope 510.Tracheascope 510 can be the tracheascope of commercially available model, for example the BF-P180 of Olympus manufacturing.Preferably, handle the visual channel that enters the patient's trachea 601 of leading to lung 600 except allowing tracheascope, this tracheascope is provided with at least service aisle of 2.0mm.Certainly, except tracheascope, endoscope can be used for different operations, and these endoscopies are provided preferably with at least service aisle of 2.0mm.The endoscope that together uses with system 101 preferably is no more than (comprising tracheascope) length of 110cm.
Figure 18 B shows the alternative method of using conduit system 101 together with tracheascope 510.Herein, as shown, clamping part 202 can be clamped on the part of tracheascope 510, and wherein tracheascope is received in the recess of clamping part 202.Some embodiments of clamping part 202 can be configured to form C shape handle, and this handle can advantageously allow and more firm being connected of tracheascope.After clamping part 202 is fixed to tracheascope 510, catheter shaft part 105 and distal tip part 107 are inserted the service aisle 511 of tracheascope 510.In some embodiments, advantageously use Tuohy-Borst adapter 515, as illustrating at present.Because Tuohy-Borst adapter 515 helps fixedly outer catheter sheath 316, during launching, the accurate placement of device does not need second people or other fixing means to pinch or keeps catheter sheath.
Figure 19 A-C shows the using and discharge an of embodiment of the blocking mechanism that can use in some embodiment described herein.Figure 19 A has presented the initial configuration of handle portion 103, and this system 101 preferably is provided to load valve or other medical treatment device wherein subsequently.Herein, locking lever 210 is in latched position, and in this embodiment, latched position occurs in locking lever 210 with respect to firm fin 208 during to remote extension.As shown in Figure 8 and above-described, when locking lever 210 during in this position, be attached to the lock tab 222 of locking lever 210 and engage with recess 220 on the handle 206 movably, thereby reduce or eliminate the probability that handle 206 movably moves.
Figure 19 B shows the system 101 in release (but not launching) position., pass through about pivoting point 226 pivot spin locking levers 210 in this case, locking lever 210 has been pushed to firm fin 208 herein.When in this position, refer again to Fig. 8, the downward pivots rotation of lock tab 222 or mobile, and break away from recess 220 on the handle 206 movably, therefore allowing movably, handle 206 endwisely slips towards clamping part 202 at the near-end longitudinal direction.
Figure 19 C shows device in being loaded in distal tip 107 launch after, the configuration of handle portion 103.Herein, movably handle 206 has axially slided to or has shifted to clamping part 202 on the near-end longitudinal direction.Some embodiments can arrange locking lever 210 and automatically reset to latched position.For example, after movably handle 206 moves through the end of lock tab 222, spring or other restoring force can promote or pivot spin locking lever 210 returns towards latched position, for example via the spring 228 (as shown in Figure 8) that is attached at lock tab 222 belows.Correspondingly, if user returns the movably handle 206 that slides along distal direction, handle portion 203 will automatically reset to the configuration shown in Figure 19 A, allows thus the expansion of another device, and does not need user to remember reset lockout lever 210.
Figure 20 A-C shows the embodiment with the conduit system 101 of the valve 500 in the chamber 405 that is loaded in the distal tip part 107.Notice that some structural details are shown in broken lines, or for purpose is not shown clearly.Conduit system 101 has been inserted into the tracheascope (not shown), and tracheascope is directed to the part of the requirement treatment of lung, is trachea 601 in this case.
When (representing by launching position 606) at the suitable expansion position of determining valve 500 herein, the operator can use line 445 that distal tip part 107 is aimed at the position 606 that is unfolded with valve, and the approximated position that valve 500 can represent from the far-end 410 online 445 of conduit discharges.In some embodiments, line 445 substantially with valve 500 can sealing against the air flue regional alignment, therefore can aim at the expansion position 606 of expection.The line 446,447 that is positioned at line 445 sides is darker color preferably, perhaps uses black colorant, so that extra contrast to be provided, thereby allows the operator easily to see line 445 by the tracheascope observation port.Moreover in use, the operator can make conduit surpass line 447 to remote extension, regains conduit with backward near-end, until arrive line 445.When regaining, the First Line 447 that runs into can be used as boundary mark, and indication is closing on line 445.If arrange like this, the telltale mark 448 (as shown in Figure 15) that then is presented on the length on the distal portions of catheter shaft part 105 also can be advantageously as another security feature, and is too far away to guarantee that the operator can not extend beyond conduit tracheascope.
Online 445 is punctual with 606 pairs at the expansion position of expection, and locking lever 210 is when moving to its unlocked position, the operator proximal direction movably handle 206 pull to clamping part 202 (totally referring to Figure 19 A-C).This launches mobile catheter shaft 302 and the cage cover 404 regained, and Simultaneous Stabilization line 304 keeps substantially static.Pusher plunger 408 in stability line 304 ends preferably is configured to contact the center rod 502 of the valve 500 that is inserted in the chamber 405, and maintaining valve 500 is in basic same position at cage cover 404 when valve 500 is regained thus.After distal openings 410 discharges from conduit, the anchor expansion of valve 500, thus contact with the wall of air flue 601, and valve 500 expansions, so that the summit of its cup-like portion totally comes in contact at 606 places, position of selecting along lung qi pipe 601.This method of deploying is useful, because by aiming at line 445, it allows device to be unfolded very near selected expansion position 606.Because distal tip part 107 is regained around this device (for example valve 500), only to compare from the device of the prior art of the far-end device for ejecting of conduit, this device among the present invention can be located and be launched more accurately.
Some embodiments of conduit system 101 also can meet some benchmark and specification, to operate acceptably in some situation with in using.For example, be used in the embodiment of expansion valve in trachea in system 101, described above, the service aisle 511 of system's 101 meeting partial insertion tracheascopies 510.Because tracheascope 510 can be inserted into and walk through patient's tortuous trachea, system 101 wherein is flexings fully, and bear reverse being applied to its power, comprising, bending and kinking power.Preferably, system 101--especially catheter shaft part 105--is configured to the following demand of balance: need enough rigidity, be used for system 101 is walked to the power at suitable expansion position in order to transmit, enough flexible simultaneously, walking by tortuous space, and be reduced in the probability of damage when extending through the tracheascope service aisle or sweep gas tube wall.In addition, system 101 is designed such that preferably may losing efficacy of any member can not stayed parts in the patient body.
Because system 101 can suffer tension force or pulling force usually in operating process, so distal tip part 107 preferably is configured to keep being attached to catheter shaft part 105, to reduce or to eliminate some part is stayed probability in the patient body.Distal tip part 107 is also preferably resisted the kinking of cage cover 404 or other members, and this can successfully carry and launch to be loaded in medical treatment device wherein.
Illustrate such as Figure 19 A-C and 20A-C, the embodiment of system 101 preferably is configured such that insertion and the operating period in tracheascope, and during the device that will be loaded into distal tip part 107 launched, its member was minimum to mobile constraint and resistance.The outside of catheter shaft part 105 and distal tip part 107 preferably all is configured to relative smooth, produces minimum friction, so that these members slide in the tracheascope service aisle freely.In addition, the friction between the inside of stability line 304 and catheter shaft 302 and/or distal tip part 107 preferably also is minimized.Preferably, be used for overcoming the chamber 405 that is loaded into distal tip 107 device (for example valve 500) friction power should less than as the power that can apply owing to development system 101 and by handle portion 103 discussed of Figure 19 A-C and 20A-C.When disposing by this way, these embodiments can be with more level and smooth, the more accurate target site that is expanded to of device.
In use, the pulmonary that user inserts patient with tracheascope 510 treats to treat from the device that conduit system 101 is launched with use.Subsequently, conduit system 101 (with for example device of valve 500, this device is advanced in the chamber 405 of distal tip 107 by preloaded) is inserted into the service aisle 511 of tracheascope 510.Refer now to Figure 19 A-C, selecting and walking to suitable expansion position, locking lever 210 is moved into its unlocked position.
After confirming that distal tip part 107 is about the position of launching the position, this can comprise will expection expansion position and any telltale mark for example line 445 (shown in Figure 15) aim at, user slides to clamping part 202 with sliding cylinder 206 on proximal direction, the trachea patient is in expansion position expansion medical treatment device (for example valve 500) thus.
In some embodiments, can improve in the following way the accuracy that pipe guide launches: pinch or the outer sheath 316 on the A/C shaft portion otherwise, with when catheter shaft 302 is regained to near-end, stability line 304 is remained on relatively static position.In preferred embodiments, conduit 101 can remove from tracheascope service aisle 511, and movably handle 206 is got back to its initial position, with another device of reloading.Therefore, can in patient's trachea, repeatedly install expansion, and not need the pulmonary 600 of tracheascope 510 from patient removed.
Should be understood that the conduit system 101 that the expansion that illustrates is at present advanced in the lung is not restrictive, and should be understood that system 101 can be used for different device is launched to enter other positions of patient, comprise stomach, endoscope or other correct position.Similarly, tracheascope not necessarily, and also can use can containment 101 and can be directed to other appropriate device of expanded position, includes but not limited to different endoscopies or peritoneoscope intubate.
Although under the description of some embodiment and embodiment, disclose the present invention, but it will be understood by those skilled in the art that, scope of the present invention not only contains concrete disclosed embodiment, but also prolongs and other alternate embodiment and/or purposes of the present invention and obvious remodeling and equivalent.In addition, although be shown specifically and described some modification of the present invention, on the basis of present disclosure, those skilled in the art understand other within the scope of the invention remodeling of falling easily.Also should predict, can make the specific features of embodiment and combination or the sub-portfolio of aspect, they still fall within the scope of the invention.The different characteristic and the aspect that should be understood that disclosed embodiment can make up or replace mutually, to form of the present invention multi-form or embodiment disclosed herein.Therefore, it should be noted that scope of the present invention disclosed herein should not limited by above-described concrete disclosed embodiment.

Claims (22)

1. one kind is used for installing the expansion conduit that launches to enter pulmonary with one, and this expansion conduit comprises:
The near-end that comprises handle portion, described handle portion comprises plunger, this plunger is centered on by handle movably, described movably handle is configured to endwisely slip in the direction along at least a portion of the length of described plunger, and wherein said plunger also comprises the locking lever that can switch between locked, this locking lever is configured to when in described latched position, prevent that described movably handle from sliding to described plunger at proximal direction, but when at described unlocked position, allow described movably handle to slide at proximal direction, and wherein said locking lever also is configured to be reset to latched position;
Catheter shaft part, this catheter shaft partly comprise the stability line of catheter shaft and described catheter shaft inside, and wherein said catheter shaft is fixed to described movably handle in the proximal end of this catheter shaft, and wherein said stability line is fixed to described plunger; And
The distal tip part, it is configured to a medical treatment device is received in the chamber, wherein said distal tip partly is fixed to the far-end of the catheter shaft of hollow, and this distal tip part also comprises the propeller plunger that is received in the described chamber, and described propeller plunger is connected to the far-end of described stability line.
2. apparatus according to claim 1, wherein the plunger of near-end also comprises C shape handle at its near-end.
3. apparatus according to claim 1, wherein said locking lever comprises lock tab, this lock tab is configured to engage with recess in the described movably handle.
4. apparatus according to claim 1, wherein said locking lever comprises the spring that is attached to described locking lever, this spring is configured to after described medical treatment device launches from described expansion conduit described locking lever be reset to latched position.
5. apparatus according to claim 1, wherein said catheter shaft partly comprise the high flexibility zone that is positioned at its far-end.
6. apparatus according to claim 5, wherein said high flexibility zone is the structure of indenting form.
7. apparatus according to claim 5, wherein said high flexibility zone is the structure of snake form.
8. apparatus according to claim 5, wherein said high flexibility zone comprise overlapping discontinuous straight cuts section.
9. apparatus according to claim 1, wherein said distal tip portion is divided and is comprised the cage cover, and this cage cover is configured to receive the chamber of medical treatment device with at least one.
10. apparatus according to claim 9, wherein said cage tackling have the stay that forms spiral structure to arrange.
11. apparatus according to claim 9, wherein said cage cover comprises one or more large fenestras.
12. apparatus according to claim 11, wherein said one or more large fenestras are configured to allow to observe and confirm that described medical treatment device has been loaded in the described chamber.
13. dividing, apparatus according to claim 1, wherein said distal tip portion comprise that at least one telltale mark, described telltale mark are configured to indicate the roughly expanded position of described medical treatment device.
14. apparatus according to claim 13, wherein said telltale mark is yellow, and two extra black bands are positioned at both sides.
15. apparatus according to claim 1, the far-end of wherein said catheter shaft part also comprises the telltale mark that at least one is long.
16. apparatus according to claim 1, wherein said handle portion also comprises the strain relief member of a frustum of a cone, and it is centered around around the proximal end region of described catheter shaft part.
17. apparatus according to claim 1 also comprises an outer sheath, it is at least around described catheter shaft proximal end region partly.
18. apparatus according to claim 1, wherein said expansion conduit is configured to be loaded into a tracheascope.
19. one kind is expanded to the method for patient pulmonary with a medical treatment device, the method comprises:
Described medical treatment device is loaded into a chamber of the distal tip part that is arranged in an expansion conduit;
Described expansion conduit is introduced a tracheascope;
A lung qi pipe is inserted in described tracheascope;
Make described tracheascope walk part to be treated to the lung qi pipe;
The part to be treated of described lung qi pipe is aimed at at least one telltale mark on the distal tip part that is positioned at described expansion conduit;
With the supravasal locking lever release of described expansion; And
Described medical treatment device is expanded to the part to be treated of described lung qi pipe.
20. method according to claim 19, wherein after described device launched, described locking lever reset to latched position.
21. method according to claim 19, wherein said expansion conduit are included in the C shape handle of its near-end, and wherein said C shape handle is attached to the part of described tracheascope.
22. also comprising, method according to claim 19, the step that described tracheascope is walked use the radial imaging instrument to follow the trail of described expansion conduit.
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DE112011105242T5 (en) 2014-03-06
CN106333749B (en) 2020-01-03
JP2014519376A (en) 2014-08-14
CN202723895U (en) 2013-02-13
JP6026513B2 (en) 2016-11-16
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GB2511375B (en) 2017-07-26
WO2012158152A1 (en) 2012-11-22

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Application publication date: 20130313