CN106333749B - Deployment catheter - Google Patents

Deployment catheter Download PDF

Info

Publication number
CN106333749B
CN106333749B CN201610855500.2A CN201610855500A CN106333749B CN 106333749 B CN106333749 B CN 106333749B CN 201610855500 A CN201610855500 A CN 201610855500A CN 106333749 B CN106333749 B CN 106333749B
Authority
CN
China
Prior art keywords
catheter
catheter shaft
deployment
deployment catheter
portion
Prior art date
Application number
CN201610855500.2A
Other languages
Chinese (zh)
Other versions
CN106333749A (en
Inventor
D·奥康奈尔
E·利杰格伦
D·H·迪拉德
H·X·冈萨雷斯
Original Assignee
斯波瑞申有限公司
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 斯波瑞申有限公司 filed Critical 斯波瑞申有限公司
Priority to CN2011800024509A priority Critical patent/CN102970945A/en
Priority to PCT/US2011/036549 priority patent/WO2012158152A1/en
Priority to CN201610855500.2A priority patent/CN106333749B/en
Publication of CN106333749A publication Critical patent/CN106333749A/en
Application granted granted Critical
Publication of CN106333749B publication Critical patent/CN106333749B/en

Links

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
    • A61F2/02Prostheses 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
    • 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
    • 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
    • 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

Abstract

A deployment catheter is disclosed herein that is preferably configured to deliver a medical device (e.g., a valve) to a location within a patient, such as the trachea of the patient. Preferably, the deployment catheter is configured for use in conjunction with a bronchoscope. In some embodiments, a locking lever is provided to reduce the likelihood of accidental deployment of the device, and the locking lever is conveniently reset after use to allow multiple device deployments.

Description

Deployment catheter

This application is a divisional application of invention patent application 2011800024509 entitled "deployment catheter" filed on 5/13/2011.

Background

Technical Field

Embodiments of the present invention generally relate to the field of medical devices, and more particularly, to methods, systems, and devices for deploying and/or implanting a device, such as a valve or other medical device, into a body using a catheter.

Description of the related Art

The incidence, prevalence and cost of pulmonary diseases such as COPD, chronic bronchitis and emphysema are increasing. The new treatment method includes lung volume reduction treatment by selective minimally invasive, non-surgical procedures. In these treatment situations, a valve may be implanted in the patient's lungs to reduce the size of the lungs and/or treat the leak. There is therefore a need for an apparatus and method for safely and consistently implanting such valves or other medical devices in the trachea of a patient (airways) for the treatment of pulmonary diseases.

Disclosure of Invention

Embodiments of the present invention generally relate to devices, systems, and methods for introducing a medical device (e.g., a valve) into a body via a catheter. A catheter is a tube that can be inserted into the body, or a body cavity, duct or vessel. Catheters may be used to allow drainage or injection of fluids into the body, or to provide access into the body by surgical instruments and/or implantable devices. To access the implantable device into the body, the implantable device may first be inserted into a catheter. In order to deliver the device to a suitable location, such as the airways in the lungs, a bronchoscope or other device may be provided with a working channel into which the catheter may be introduced. Delivery and deployment of the device inserted in the catheter may then be performed. In a preferred embodiment, a catheter loaded with a valve delivers the valve to a location in the pulmonary trachea.

Using the methods, systems, and devices described herein, a valve or other medical device (deployable or otherwise) can be introduced into a catheter or other deployment instrument. After the valve or other medical device has been loaded into the catheter or other deployment instrument, the valve or other medical device may be implanted or positioned within the patient using the catheter or other deployment instrument. Preferably, the valve or other medical device is loaded into a lumen or other space provided in the distal tip region of the catheter or other deployment instrument. In some embodiments, the catheter or other deployment instrument can be loaded into the working channel of an bronchoscope or other such instrument and navigated to a suitable deployment location, such as the trachea of a patient.

Embodiments of the instrument may have additional features (alone or in combination) that may exhibit advantages and usefulness in aiding deployment. For example, a locking lever may be provided that reduces or eliminates the possibility of accidental deployment of the valve or other device, and may also be reset after deployment to allow for multiple device deployments. In addition, a grip, in some embodiments a C-handle, may be provided that may be clipped onto the bronchoscope to assist in deployment of the valve or other medical device, while also providing an ergonomic handle. Positioning markers may also be provided on the device, particularly near the distal end of the device, which may assist the operator in aligning the implantable device with the selected deployment site. The distal tip portion may also be configured as a cage-like structure and may be provided with one or more fenestrations (fenestrations) that allow for visualization and confirmation that the valve or medical device has been properly loaded into the distal tip. Of course, other features and details will be discussed in detail herein.

In one embodiment, a deployment catheter for deploying a device into a lung is described, wherein the deployment catheter comprises:

a proximal end comprising a handle portion, the handle portion comprising a plunger surrounded by a movable handle configured to slide axially in a direction along at least a portion of a length of the plunger, and wherein the plunger further comprises a locking lever switchable between a locked position and an unlocked position, the locking lever configured to prevent the movable handle from sliding proximally toward the plunger when in the locked position, but to allow the movable handle to slide proximally when in the unlocked position, and wherein the locking lever is further configured to return to the locked position;

a catheter shaft portion comprising a catheter shaft and a stabilizing wire inside the catheter shaft, wherein the catheter shaft is fixed to the movable handle at a proximal end of the catheter shaft, and wherein the stabilizing wire is fixed to the plunger; and

a distal tip portion configured to receive a medical device in a lumen, wherein the distal tip portion is secured to the distal end of the hollow catheter shaft, and the distal tip portion further comprises an advancer plunger received in the lumen, the advancer plunger being connected to the distal end of the stabilizing wire.

Some embodiments provide for the proximal plunger to include a C-shaped handle at its proximal end. In some embodiments, the locking lever includes a locking tab configured to engage with a notch in the movable handle. The locking lever may also include a spring attached to the locking lever, the spring configured to return the locking lever to a locked position after the medical device has been deployed from the deployment catheter.

In some embodiments, the catheter shaft portion includes a high flexibility region at its distal end, which may include a staggered-canine (splice), serpentine, or overlapping straight cuts.

Other embodiments provide for the distal tip portion to include a cage with at least one lumen configured to receive a medical device. The cage may have an arrangement of struts forming a helical configuration and may include one or more large fenestrations. In some embodiments, the one or more large fenestrations are configured to allow for visualization and confirmation that the medical device has been loaded into the lumen. The distal tip portion may also include at least one positioning marker configured to indicate an approximate deployment position of the medical device. In some embodiments, the positioning mark is yellow, with two additional black bands on either side. In some embodiments, the distal end of the catheter shaft portion further comprises at least one long positioning marker.

In some embodiments, the handle portion further comprises a frustoconical strain relief surrounding a proximal region of the catheter shaft portion. Some embodiments may also include an outer sheath surrounding at least a proximal region of the catheter shaft portion. Preferred embodiments may be configured to be loaded into a bronchoscope.

Another embodiment provides a method of deploying a medical device into a lung of a patient, the method comprising:

loading the medical device into a lumen located at a distal tip portion of a deployment catheter;

introducing said deployment catheter into a bronchoscope;

inserting the bronchoscope into a pulmonary trachea;

passing the bronchoscope to a portion of a lung trachea to be treated;

aligning a portion of the pulmonary trachea to be treated with at least one positioning marker located on a distal tip portion of the deployment catheter;

unlocking a locking lever on the deployment catheter; and

deploying the medical device to a portion of the pulmonary trachea to be treated.

In some embodiments, the locking lever returns to a locked position after the device is deployed. In other embodiments, the deployment catheter comprises a C-shaped handle at its proximal end, and wherein the C-shaped handle is attached to a portion of the bronchoscope. In further embodiments, the step of navigating the bronchoscope further comprises tracking the deployment catheter using a radiographic imaging tool.

Drawings

The foregoing and other features, aspects and advantages of the present invention are described in detail below with reference to the drawings of various embodiments, which are intended to illustrate and not to limit the present invention. The drawings include the following figures, wherein:

figure 1 shows a side view of one embodiment of a catheter.

FIG. 2 shows a close-up side view of one embodiment of a handle portion of a catheter.

Fig. 3-4 show top and bottom views, respectively, of an embodiment of a handle portion of a catheter.

Fig. 5A-B show left and right side views of one embodiment of a catheter.

Fig. 6 shows a cross-sectional view of one embodiment of a catheter shaft.

FIG. 7 is a cross-sectional view of one embodiment of a handle portion of a catheter.

Fig. 8 shows a close-up cross-sectional view of one embodiment of a catheter lock mechanism.

Fig. 9A-B show close-up views of prongs of one embodiment of attaching a catheter shaft to a catheter handle.

Fig. 10A-C illustrate embodiments of regions of high flexibility present on a catheter shaft.

Figures 11A-B show close-up views of embodiments of a distal tip of a catheter without a loading valve therein and with a valve loaded therein, respectively.

Figures 12A-B show close-up cross-sectional views of embodiments of a distal tip of a catheter without a loading valve therein and with a valve loaded therein, respectively.

FIG. 13 is a close-up view of the distal-most end of the distal tip of one embodiment of a catheter.

Fig. 14 shows an embodiment of a connector mechanism that may be used to attach the distal tip to the catheter shaft.

Fig. 15 shows a close-up view of the distal tip of an embodiment of a catheter shaft with locator markings added.

Fig. 16A-H illustrate different embodiments of the distal tip of the catheter.

Fig. 17 is a view of an embodiment of an encapsulated catheter and valve loader system.

Figure 18A shows an embodiment of a catheter loaded into a bronchoscope inserted into a lung trachea.

Figure 18B shows an embodiment of a catheter with a grip attached to a bronchoscope.

Fig. 19A-C illustrate how the latching mechanism present in one embodiment of a catheter handle operates.

Figures 20A-C illustrate deployment of a valve into an air inlet tube using a valve of one embodiment loaded into a catheter.

Detailed description of the preferred embodiments

The catheter deployment system and related components and components of the system will now be described with reference to the drawings of one or more embodiments. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner. Rather, the terminology is used only in connection with the detailed description of the embodiments of the systems, methods, and related components. Moreover, embodiments may include several novel features, no single one of which is solely responsible for its desirable attributes or which should not be considered essential to practicing the inventions herein described.

The terms "valve", "deployable medical device", "medical device", and "device" as used herein are broadly interchangeable terms, and unless otherwise indicated, in their meaning, may include, without limitation, stents, valves, lung volume reduction valves, balloons, probes, markers (including radiopaque and other forms of fiducial markers), anchoring devices, or any other medical device (deployable or otherwise) configured to be loaded or introduced into a catheter or other deployment instrument and subsequently delivered or deployed. Although some embodiments described herein are directed to deploying medical devices into the trachea, the present disclosure is not so limited, but may be deployed to other vessels, passageways, and body cavities, such as, but not limited to, humans and animals. In certain embodiments, the valve and/or medical device is of the type disclosed in U.S. patent No. 6,293,951 or 7,757,692, each of which is incorporated herein in its entirety.

Fig. 1 shows one embodiment of a deployment catheter system 101. The system 101 comprises several co-acting different parts. The proximal end of the system 101 comprises a handle portion 103 coupled to a catheter shaft portion 105, the catheter shaft portion 105 terminating in a distal tip portion 107 at the distal end of the system 101. In a preferred embodiment, the proximal handle portion 103 is connected to the distal tip portion 107 via the catheter portion 105, the distal tip portion 107 preferably containing a medical device to be deployed into position using the system 101. In some embodiments, the distal tip portion 107 may include (or be configured to receive) a device such as a valve to be deployed in a tracheal passage.

Fig. 2-5 show other external views of handle portion 103. Handle portion 103 is preferably adapted to be grasped or held by a user and includes several components. The handle portion 103 includes a grip 202 connected to a plunger 204. A movable handle 206 is attached to the plunger 204, such as may be disposed about the plunger 204. A catheter shaft portion 105 is connected to the handle portion 103 at the distal end of the handle portion 103.

The grip portion 202 of the handle portion 103 may be configured with a notch that may allow a user's thumb to grasp or grasp the handle portion 103 when the device contained in the distal tip portion 107 is ready for deployment. As shown, the clamp 202 may form a C-clamp. The clamp portion 202 may take other shapes, for example, but not limited to, the clamp portion 202 may have a U-shaped, V-shaped, or concave inner surface. In some embodiments, as described in further detail below in fig. 18B, the grip 202 can be attached to a device, such as an endoscope, or more specifically, a bronchoscope. The grip 202, which may be held or operated by a user's hand, and other components of the system 101 may be provided with a non-slip or rubberized coating to provide additional grip to the user.

The grip 202 is attached to a plunger 204. The plunger 204 may be provided with an ergonomic finger embossing 205, which ergonomic finger embossing 205 may provide a more secure or comfortable grip for a user's fingers when operating the system 101.

The movable handle 206 is configured to movably engage with the plunger 204 such that the movable handle 206 is slidable back and forth in a longitudinal axial direction, for example, along at least a portion of the plunger 204. From the position shown in fig. 2, the movable handle 206 may be moved in a proximal direction towards the grip 202.

At the distal end of the movable handle 206, a securing tab (security tab)208 and a locking lever 210 may be attached to the plunger 204. The locking lever 210 is configured to engage the movable handle 206 when in the illustrated locked position to reduce or eliminate the possibility of the movable handle 206 moving in a proximal direction toward the grip 202. The movable handle 206 preferably includes an ergonomic aid, such as a ridge 207, that allows a user to easily manipulate and pull the movable handle 206 during deployment of the medical device. In some embodiments, all or a portion of the movable handle 206 may be provided with a slip-resistant or rubberized coating to provide additional grip to the user.

Handle portion 103 may also include a strain relief member 212. Preferably, the strain relief member 212 is coupled to the handle portion 103 and is made of an elastic material, such as a polymer, including, for example and without limitation, rubber, a thermoplastic elastomer (e.g., Santoprene)TM,) Polyurethane, polyvinyl chloride,And a siloxane. The strain relief member 212 may be approximately conical or frustoconical in shape with a longitudinally extending central opening configured to closely conform to the outer sheath 316 (if provided) of the catheter shaft portion 105 or the catheter shaft 302. The strain relief member 212 may reduce the likelihood of kinking or bending of the catheter shaft portion 105 near the point of engagement of the catheter shaft portion 105 with the handle portion 103, particularly when the catheter shaft portion 105 is inserted into an instrument (e.g., a bronchoscope), and is manipulated during use.

Referring now to fig. 6, a cross-sectional view of the catheter shaft portion 105 is shown. The catheter shaft 302 is hollow and includes a stabilizing wire 304 extending longitudinally therein. The catheter shaft 302 is preferably constructed of a resilient and durable (robust) material (e.g., metal or metals) that resists stretching and plastic deformation while remaining flexible enough to be guided through tortuous passageways and other similar converging conduits. Suitable metals may include stainless steel, Nitinol (Nitinol), and the like. In some embodiments, polymer tubes work well, and some embodiments may be made, for example, from continuous polymer extrusion. These extrusions may also include interweaving for additional strength and durability, and may be constructed from polymers such as polyimide. The stabilizing wire 304 may likewise be constructed of similar materials.

In some embodiments, a lubricious coating or material may be added to one or both of the stabilization wire 304 or catheter shaft 302, which may help the two components slide past each other more freely and generally without clogging or sticking. For example, a polymer (e.g., PTFE or parylene) may be coated on the stabilization wire 304. A coating (e.g., FEP) may also be extruded onto the stabilizing wire. A heat shrinkable polymer (e.g., PTFE or polyethylene) may also be added to the stabilizing wire 304.

In some embodiments, the stabilizing wire 304 may preferably have a varying diameter along its length. The diameter may vary, for example, in a continuous or gradual decrease, or in a stepwise (stepwise) manner. Without wishing to be bound by theory, it is believed that some embodiments of the stabilizing wire 304 having a larger diameter at the proximal end (i.e., toward the handle portion 103) to reduce or eliminate the possibility of buckling under higher loads; while having a smaller diameter toward the distal end (i.e., near the tip portion 107) to provide additional flexibility. In one embodiment, the stabilizing wire 304 has a diameter of 0.020 inches from the proximal end until approximately 1 inch is passed through the outer sheath 316. The diameter of the remainder of the stabilizing wire 304 is stepped to 0.016 inches. This embodiment may be used in a catheter shaft 302 having an inner diameter of approximately 0.022-0.024 inches such that the gap between the catheter shaft 302 and the stabilization wire 304 on each side is approximately 0.001-0.002 inches at the proximal end and 0.003 inches at the distal end.

Referring to fig. 7, a cross-sectional view of handle portion 103 is shown. Figure 8 shows a close-up of the cross-sectional view. In a preferred embodiment, the grip 202 is connected to the stabilizing wire 304, although in some embodiments, the stabilizing wire 304 may also be connected to the plunger 204, or alternatively to the plunger 204. The stabilization wire 304 is disposed within the catheter shaft 302, the catheter shaft 302 preferably being configured to slide in a longitudinal direction about the stabilization wire 304.

In certain embodiments, a crimp tube 305 is used to connect the stabilizing wire 304 to the clip portion 202. The crimp tube 305 is preferably constructed of a harder metal than the stabilizing wire 304, such as a stainless steel alloy (e.g., SS304), and is formed as a hypotube (hypotube). Preferably, the crimp tube 305 is crimped over the proximal end of the stabilizing wire 304, the proximal end of the crimp tube 305 being held within the grip 202 and the distal end of the crimp tube 305 being held within the remainder of the body of the plunger 204. In some embodiments, the crimp tube 305 may extend partially over the catheter shaft 302, for example, a short length of 0.1 inches, as this may provide additional resistance to buckling of the catheter shaft 302 when force is applied to the catheter shaft 302. In some embodiments, crimp tube 305 may have an inner diameter of approximately 0.039 inches with a wall thickness of 0.010 inches.

The catheter shaft 302 is connected to the movable handle 206 via one prong 216. Because movable handle 206 is preferably configured to slide back and forth along plunger 204, and because movable handle 206 is coupled to catheter shaft 302, movement of movable handle 206 causes corresponding movement of catheter shaft 302 relative to stabilization wire 304. This movement allows the device mounted on distal tip 107 to pop up and deploy, as will be discussed below. In addition, the locking lever 210 may be provided with a locking tab 222, which locking tab 222 engages a notch 220 on the movable handle 206, thereby helping to reduce or eliminate the possibility of the movable handle 206 sliding along the plunger 204. Such an arrangement may be used to help reduce or eliminate unintended or premature deployment of the device from the catheter system 101. In certain embodiments, the catheter shaft 302 may instead be connected to the plunger 204 and the stabilizing wire 304 may be connected to the movable handle 206 via the prongs 216.

The catheter shaft 302 is preferably secured to the handle portion 103, and in certain embodiments, one or more intermediate members may form part of this connection. In some embodiments, referring now to fig. 9A-B, catheter shaft 302 may be secured to a forked intermediate member, such as fork 216, and catheter shaft 302 may be clamped, for example, in a notch of the forked intermediate member. The prong 216 is in turn connected to the movable handle 206. The movable handle 206 is omitted for clarity, but the relationship of the movable handle 206 to other components can be seen in fig. 7-8.

Fork 216 preferably includes at least two tines 217. The tines 217 have a spacing from one another that is less than the diameter of the catheter shaft 302. To connect the catheter shaft 302 to the prongs 216, the catheter shaft 302 (preferably configured with a circular cross-section) may thus have one or more indentations or cavities 308 formed thereon. The notch or cavity 308 allows the catheter shaft 302 to be received in the space between the two prongs 217, as the distance of the cavity 308 along the catheter shaft 302 will result in a distance of smaller cross-section of the catheter shaft 302 to allow the catheter shaft 302 to be inserted and secured in the space between the two prongs 217. Accordingly, an axially fixed connection may be formed between the catheter shaft 302 and the prongs 216. Because the stabilizing wire 304 is positioned within the catheter shaft 302, care must be taken that the notches or cavities 308, 310 do not substantially interfere with the relative free movement of the catheter shaft 304 or cut into the catheter shaft 304.

Testing has shown that prongs 216 of one embodiment constructed of stainless steel (prongs 216 may be constructed of any suitable rigid material, such as a metal comprising stainless steel) can withstand greater than 20 pounds of force before failing. This configuration makes the system 101 more likely to remain intact because the user is unlikely to apply such a large force during deployment, and failure of the prongs 216 is less likely to cause the catheter shaft 302 to separate from the rest of the system 101.

Referring back to fig. 1, an outer sheath 316 may also be provided over the catheter shaft portion 105. The outer sheath 316 may be positioned between the catheter shaft 302 and the strain relief member 212 and may be used (along with the strain relief member 212, if provided with the strain relief member 212) to minimize kinking and torsional loading of the catheter portion 105. To ensure a reliable connection of the sheath 316, the sheath 316 is preferably secured to the plunger 204, such as by insert molding (insert molding) or adhesive. In some embodiments, the outer sheath is between 22 and 39 inches in size and the wall thickness is between approximately 0.005-0.015 inches, preferably 0.010 inches. Preferably, the outer sheath 316 has a void or gap between itself and the catheter shaft 302. In some embodiments, the gap is between about 0.003-0.010 inches in size, preferably 0.005 inches on each side. In some embodiments configured to be sterile (e.g., using ethylene oxide gas sterilization), the gap between the catheter shaft 302 and the outer sheath 316 may be designed to allow sufficient flow of sterilant between the two components.

The outer sheath 316 is preferably constructed of a material including, for example, a polymer formed in a single polymer extrusion (single polymer extrusion), such as HDPE, nylon-12, polyethylene terephthalate, and polyethylene terephthalate,Polyurethane, or mixtures of the above. In some embodiments, the outer sheath 316 is co-extruded from two different materials. On the side of the outer sheath 316 facing the catheter shaft 302, a lubricious material, such as HDPE, FEP, or other suitable material may be used. On the outside of the sheath 316, polymers can be used-for exampleOr nylon-12, or other suitable material to achieve a balance between pushability (e.g., limiting the amount of force that a user may apply), mechanical strength (e.g., resistance to deformation under load), kink resistance, friction with the interior of the bronchoscope, and manufacturability. In some embodiments, radiopaque materials (e.g., barium sulfate) may be incorporated into the sheath 316 and/or other components of the catheter system 101.

Referring to fig. 10A-C, a series of cuts may be formed along substantially all or a portion of the catheter shaft 302. These cuts may define one or more regions of increased flexibility 330, the regions 330 generally being able to bend or flex better than the remaining uncut catheter shaft 302. In some embodiments, it has been found that the catheter system 101 performs well if a portion of the distal end of the catheter shaft 302 has a highly flexible region 330 cut into it, as the distal portion of the catheter shaft 302 requires a greater degree of bending to pass through, for example, tortuous tracheal passages. The flexibility of the high flexibility region 330 may be designed according to the requirements of a particular application. The flexibility is varied, for example, by modifying the thickness of the catheter shaft 302, the material used therein, and the spacing, pitch, and angle between cuts in the high flexibility region 330. Preferably, the cut extends in a helical fashion along the catheter shaft 302.

Further, the high flexibility region 330 need not be a single pitch as shown in fig. 10A, but rather, with reference to fig. 10B, the high flexibility region 330 may instead be a variable pitch, where the spacing or pitch may vary continuously or in steps. Furthermore, although the cuts shown in these figures may be made as a continuous single cut, one or more discontinuous cuts may be used to make the highly flexible region. In these figures, the cuts that make up the high flexibility region 330 are made in a "dog-staggered" configuration that forms a zigzag or zig-zag pattern. Other possible cuts are the "serpentine" configuration as shown and discussed below in fig. 16B and C. In this serpentine configuration, the cuts are smoother, more rounded, and have a longer amplitude than the canine staggered pattern. Other cut types are possible and contemplated, including straight cuts, partial or dashed cuts, zig-zag cuts, sinusoidal cuts, and the like.

Fig. 10C shows one embodiment of a high flexibility region 330 comprising overlapping discontinuous linear cuts, each cut extending approximately about half of the circumference of the catheter shaft 302. In this embodiment, a punch 331 may be provided at one or more ends of each cut. In some cases, punch holes 331 may be made as part of a laser cutting process used to create the cuts, but the cuts may be made using any suitable process, such as chemical etching. The punched holes 331 may also be used to provide additional strength to the catheter shaft 302, as it is believed that the punched holes 331 may help reduce or eliminate the possibility of crack propagation when the catheter shaft 302 is subjected to different stresses.

In practice, the machining of the highly flexible region 330 and the cuts making up the highly flexible region 330 may find the right balance between the required flexibility and the type of cut as desired. For example, while wider or larger cuts may provide additional flexibility, in some cases these may weaken the catheter shaft 302 to an unacceptable degree. Different cutting section types may also work more or less satisfactorily in fatigue tests. In addition, some cuts may cause a portion of the highly flexible region 330 to abrade the working channel of the bronchoscope, but post-processing after the cut is made may include steps such as edging or ultrasonic cleaning that may at least partially alleviate such concerns. The type of cut described above may also be adjusted according to the length of the one or more highly flexible regions 330.

In a preferred embodiment, a highly flexible region 330 having a size of 3 to 6 inches (pitch between cuts between 0.010 to 0.100 inches) has been found to work effectively. It has been found that in some embodiments, a cut width (kerf) in the range of between 0.0015 and 0.0030 inches is satisfactory.

In certain embodiments, it may be preferable to cover at least the high flexibility region 330 with a flexible protective layer, such as a polymer or heat shrink material. Such a protective layer may at least partially reduce wear inside the working channel of the bronchoscope due to the cut, and may also reduce or eliminate the possibility of damage or over-elongation of the catheter shaft 302, which may help make the catheter available for multiple deployments. In addition, the protective layer may also be lubricious or lubricious, thereby allowing the catheter shaft 302 to slide more easily within the bronchoscope working channel.

Referring now to fig. 11A-B and 12A-B, the distal tip portion 107 may be joined to the catheter shaft portion 105 via a connector 402. More specifically, in some embodiments, the connector 402 connects the outer catheter shaft 302 to the distal tip portion 107. In a preferred embodiment, the distal tip portion 107 may include a cage 404, the cage 404 being connected to the catheter shaft 302 via a connector 402. The cage 404 may be made of one or more sufficiently durable materials, including metals such as stainless steel and nitinol. In some embodiments, the cage 404 may be constructed from preformed tubing, and some other embodiments may have the cage 404 constructed from flat portions of material that are subsequently wound in a longitudinal or helical direction to form a tube.

The distal tip portion 107 is preferably configured to contain a lumen 405 therein, the lumen 405 being sized to accommodate a suitable device to be subsequently deployed. Preferably, the cage 404 includes a cavity 405 located within the interior space of the cage 404.

In some embodiments, as shown in fig. 11B and 12B, the lumen 405 can house a medical device, such as the valve 500. In some cases, valve 500 may be loaded into cavity 405 through distal opening 410 using a valve loader of the type described in US serial nos. 12/249,243 and 12/422,179, each of which US serial nos. 12/249,243 and 12/422,179 is incorporated herein in its entirety. Once loaded into the cavity 405, the proximal end of the device (e.g., valve 500) abuts against the pusher plunger 408, which in turn connects to the stabilizing wire 304. In use, proximal movement of the movable handle 206 with respect to the plunger 204 in the handle portion 103 causes the cage 404 to retract with respect to the pusher plunger 408, thereby releasing a device (e.g., valve 500) received in the cavity 405 from the opening 410.

Fenestrations 409 are preferably located on at least a portion of the cage 404 and may be used to improve visualization of the device located therein and to improve flexibility of the distal tip portion 107. The remaining struts 411 form a cage or frame-like structure and may include a helical or staggered helical pattern, although different configurations and patterns are possible. Fenestrations 409 may be laser cut, for example. Other methods, such as photochemical milling, may also be utilized.

Preferably, the cage 404 also includes one or more large fenestrations 413. This large aperture 413 facilitates viewing of the device located within the cavity 405 and confirms that the device has been properly or properly loaded in the cavity 405. The large aperture 413 may also be used to provide a blank area for a band of location markers or other location markers (discussed in detail below). Preferably, the entire cage 404 is constructed from a single piece of material, and a distal portion of the cage 404, including the rim 415, may be connected to a proximal portion of the cage 404 via longitudinal struts 414.

In the manufacture of the distal tip portion 107, it may be advantageous to coat the distal tip portion 107 and the inner and/or outer portions of the cage 404. For example, coating with a softer material (e.g., a polymer) may effectively avoid injury to body tissue during use of the catheter and help the distal tip portion 107 slide freely within the working channel of a bronchoscope or other instrument. In addition, coating the interior portion of the catheter may help reduce or eliminate damage to the medical device loaded therein, or reduce or eliminate the possibility of obstructing the deployment of the medical device.

Thus, certain embodiments provide a liner (e.g., composed of a polymer such as polytetrafluoroethylene) on at least a portion of the inner surface of the cage 404 or cavity 405, in combination with a liner (which may be composed of a polymer such as polytetrafluoroethylene) on at least the outer surface of the distal tip 107 portion-composition).

In some embodiments, these coatings or liners may be reflowed (reflowed) onto the distal tip portion 107. Using a mandrel, heat may be applied to reflow the liners onto the metal portion of the distal end 302. Preferably, the selected liner is at least partially transparent with respect to the fenestrations 409, 413 so that the medical device loaded therein can be inspected. Different polymers and polymer types may be used along different portions of distal tip 107, with, for example, a clear polymer being used along only one portion of distal tip 107, while an opaque or colored polymer is used along a different portion of distal tip 107, to allow the catheter to be specifically tailored for the intended application and use. These polymer coatings and reflowing may also incorporate locating marks on or in the distal tip portion 107, as discussed below and in fig. 15. Different methods may be used to coat the distal tip portion 107, including dip coating, extrusion, application of heat shrink material, and the like.

In a preferred embodiment, the rim 415 around the opening 410 at the distal end of the distal tip portion 107 is configured to be smooth and atraumatic to reduce or eliminate the possibility of damage to body tissue during insertion and deployment of a device located in the cavity 405.

Preferably, referring to fig. 13, the rim 415 includes a series of small welds (welds) arranged circumferentially around the opening 410, which may be made, for example, using laser welding to provide smooth, rounded ends. In this case, the rim 415 may thus be configured to provide an atraumatic tip that minimizes snagging or other catching of the device being deployed from the cavity 405, while also making it durable and capable of supporting multiple uses. In other embodiments, the rim 415 may be covered by a layer of polymer or other soft material.

Referring now back to fig. 11A-B and 12A-B, in some embodiments, the connector 402 may be roll welded (seam-welded) along the boundary joining the connector 402 to the distal tip portion 107 via the cage 404 or the distal end of the catheter shaft 302. Such welding is preferred because it provides a smoother transition from the catheter shaft portion 105 to the distal tip portion 107, thereby reducing operator handling difficulties and helping to provide smooth continuous movement of the system 101 during deployment. Spot welding may also be used, but care should be taken to reduce the size of the spot weld to prevent over-projection, since there is a risk that such a weld will catch or snag within the bronchoscope.

Referring to fig. 14, certain embodiments provide a connector 402 constructed from a multi-part design. In these embodiments, the compression cone 430 is attached to the distal end of the outer catheter shaft 302, such as by welding. A ferrule (ferule) 432 is attached to the distal end 402, such as by welding or simply by mechanical interlocking, and the ferrule 432 may then be pushed over the compression cone 430 to sandwich the proximal end of the cage 404. The interlocking connection includes a connector 402 and forms a strong connection that is able to withstand most tensile forces. The samples have been tested to be able to withstand a tensile force of at least 100N.

Turning now to fig. 15, one embodiment of the system 101 may be provided with locating marks. These positioning markers may be provided, for example, on a portion of the distal tip portion 107 and the distal end of the catheter shaft portion 105. Generally, the positioning marks help the operator to determine the position of the system 101 with respect to an external target. The locating marks may be visible and thus useful in a limited visibility environment, such as the field of view seen through a bronchoscope. More specifically, the positioning indicia may aid in selecting and indicating the appropriate deployment site for a medical device loaded in the catheter, and for allowing the operator to determine whether the catheter has extended too far out of the working channel of the bronchoscope or other delivery device.

Certain embodiments may be provided with one or more positioning indicia, such as wires 445, 446, 447, which may aid in selecting and indicating the appropriate deployment site for a medical device loaded in the catheter. Here, when the catheter containing the device is loaded into the bronchoscope and guided to a portion of the body requiring treatment (e.g., the pulmonary trachea), the operator may use line 445 to align the catheter with the site where the medical device is to be deployed, as line 445 would indicate the approximate location where the medical device is to be released from opening 410. In some embodiments, the device may be a valve 500 deployed in the trachea, and in these cases, the line 445 is generally aligned with the airway region against which the membrane of the valve 500 is to be sealed. These embodiments are described in further detail below and in fig. 20A-C.

The line 445 may be particularly advantageous to aid in the visualization of a suitable deployment site through a bronchoscopic viewing channel, and some embodiments allow the line 445 to be surrounded or sandwiched by other black or differently contrasting bands of color 446, 447 to provide additional contrast. Although wire 445 may be marked at distal tip portion 107 by suitable means, such as pad printing or ink jet printing, it is sometimes necessary to not employ exposed pigment in the construction of wire 445 for reasons of biocompatibility. In these cases, some embodiments may use marker bands disposed around the distal tip portion 107. These marking tapes may consist of polymeric tapes, e.g. of heat-shrinkable polymers-e.g. of the type-construction. Since the yellow wire 445 has been found to be advantageous in certain applications, a gold marker band may be sleeved over the distal tip portion 107. The marker bands may be constructed of any suitable material, preferably a highly visible material. Materials such as gold or platinum mixed with iridium have been found to be acceptable materials. Alternatively, the marker band as line 445 may be encapsulated under a liner as described above in the reflow process, or encapsulated in a further, and preferably at least partially transparent, polymer (e.g., such as) Below the layer.

In some embodiments, a line 445 or other positioning marker may be formed by cutting a row or series of fenestrations into the distal tip portion 107 such that no additional material is required to form the corresponding positioning marker. Further, although wire 445 is described above as being located on distal tip portion 107, other embodiments may place wire 445 in other portions of system 101. For example, the line 445 may be on the stabilizing wire 304 or plunger 408, with an associated aperture or fenestration cut into the distal tip portion 107 to allow the line 445 to be seen, if desired.

In addition, certain embodiments may be provided with long positioning markers 448, for example, at the distal portion of the catheter shaft 105. The long positioning indicia 448 may serve as a warning feature to the operator that the catheter system 101 has extended too far through the bronchoscope. The long positioning indicia 448 is preferably colored or tinted, such as a contrasting color (e.g., yellow), to be easily visible to the operator when the catheter is to extend through the bronchoscope. The long positioning indicia 448 may be placed on the catheter shaft 105 using any suitable means, including those previously described for the wires 445, 446, 447. Preferably, the long positioning indicia 448 may be constructed of a suitable heat-shrinkable polymer, which in some cases may be subsequently covered by a clear or colorless protective polymer layer. In some embodiments, the long positioning indicia 448 may be between 5 and 10 inches in size, preferably 6 inches, and may be located approximately 2 inches from the distal tip.

Although the positioning markers discussed above refer primarily to visual indicators, the positioning markers used in system 101 may also be configured to be positioned using other means. For example, any of the positioning markers or lines 445, 446, 447, 448 may be constructed of or include a radiopaque material (e.g., barium sulfate) for positioning using a radiographic method. In MRI compatible embodiments of system 101, MRI contrast agents may also be incorporated into the localization markers. An active (powered) or passive (e.g., passive RFID) location marker light (beacon) may also be incorporated into the distal tip portion 107, which may function in conjunction with or in place of the location markers discussed above, and which may function in conjunction with mapping software to track the location of the distal tip portion 107 in real time and without requiring visual confirmation of the location of the distal tip portion 107 relative to the deployment site. These registration marks may also be hybrid registration marks combining multiple registration methods, such as both radio-opaque and visible registration marks.

Fig. 16A-H illustrate different embodiments of the distal tip portion 107. Although these designs are somewhat similar to FIGS. 11A-B and 12A-B, additional differences and features will be discussed herein. Turning first to fig. 16A, one embodiment of the distal tip portion 107 is shown that includes a staggered helical configuration in the cage 404 (as opposed to a continuous helical or spiral configuration in fig. 11A-B). The additional material joining struts 411 together may provide additional strength against external and internal forces (e.g., torsional or bending forces) that may be applied to the tip during use. In a preferred embodiment, the cage 404 may be constructed from a nitinol sheet, chemically etched, and rolled into a cylindrical shape.

In addition, the connector 402 is provided herein with a multi-part connector similar to that discussed with respect to FIG. 14. A location marker including line 445 may also be presented. As previously discussed, this embodiment includes a highly flexible region 330 with a dog-staggered cut configuration on the catheter shaft 302.

Fig. 16B shows a similar embodiment with a different high flexibility region 330 on the catheter shaft 302, this time the high flexibility region 330 is formed in a serpentine design.

Turning now to fig. 16C, this embodiment includes a high flexibility region 450 that has been integrated onto the distal tip portion 107, and this high flexibility region 450 is otherwise similar to the high flexibility region 330 shown in fig. 16A, except that here the region 450 is on the distal tip portion 107. The highly flexible region 450, here made in a serpentine cut configuration, is connected to the catheter shaft portion 105 via a connector 402 and to the cage 404 via a second connector 430. Furthermore, in addition to the high flexibility region 450 shown here, some applications may require the addition of another additional high flexibility region 330 of the type previously described to the catheter shaft 302. In some cases, a lining of PTFE or other lubricious polymer may be provided on the interior of the highly flexible region and/or the cage region to minimize buckling of the stabilization wire extending through the finished catheter.

Fig. 16D shows another embodiment of the distal tip portion 107 similar to the embodiment described in fig. 16C. Here, the high flexibility region 450 includes a canine-staggered design.

Fig. 16E illustrates an embodiment of the distal tip portion 107 similar to the embodiment illustrated in fig. 11A, wherein the cage 404 comprises a helical configuration. Here, the high flexibility region 330 located on the catheter shaft 302 includes overlapping discontinuous linear cuts, each cut extending around approximately one-half of the circumference of the catheter shaft 302. These cuts may be similar to the configuration shown in fig. 10C. Because these cuts are discontinuous, some embodiments of such high flexibility regions 330 may have additional strength compared to other high flexibility region types shown herein.

Fig. 16F shows one embodiment of the distal tip portion 107 including a tapered portion. Here, the cage 404 is connected to a tapered portion 452 via the second connector 403, the tapered portion 452 having a diameter that tapers towards its proximal end. The tapered portion 452 is connected to the catheter shaft 302 via a connector 402 and may be provided with a highly flexible region 330 similar to that described previously. In some embodiments, the tapered portion and/or cage may be formed by making a spiral wrap from a sheet of a rigid material (e.g., nitinol) that has been photochemically etched (although different metals or materials may be used). Some advantages of this tapered embodiment may include smoother movement of the catheter system 101 through the bronchoscope working channel.

Fig. 16G shows another embodiment of the distal tip portion 107 including a different tapered portion. Here, the cage 404 itself is formed as a single unit (in contrast to fig. 16E) and tapers in size towards its proximal end. In some cases, such a cage design of fig. 16G is cheaper to manufacture and assemble than the multi-piece design of fig. 16E, and in some cases may be photochemically etched from a single nitinol sheet, followed by roll forming. This one-piece tapered embodiment may also be manufactured such that the staggered spiral configuration shown here does not extend as close as shown here, such that this embodiment may be similar to the embodiment shown in fig. 16F but without the second connector 403. Preferably, the cage 404 is attached to the catheter shaft portion 105 using a connector 402 of the type described above in fig. 14. As with fig. 16F, a highly flexible region 330 (here of the "interdigitation" type) may be present on the catheter shaft 302.

Fig. 16H illustrates a different configuration of a cage 404 that may be used in certain embodiments of the distal tip portion 107. Here, the cage 404 is not a helical or spiral configuration, but is formed in an interwoven configuration as shown. This configuration is preferably formed by laser cutting, but different manufacturing methods (e.g., photochemical milling) are also possible. The configuration of this embodiment of cage 404 is advantageous in applications where additional flexibility is required of distal tip portion 107. In some configurations, such as when the cage 404 is constructed of nitinol, a nitinol compression ring may be used to secure the cage 404 to the catheter shaft portion 105, rather than the connector 402 or the type of connector shown in fig. 14.

Referring now to fig. 17, the catheter system 101 may be packaged with a tube 110 for protecting the catheter shaft portion 105 and the distal tip portion 107. A valve loader 115 may also be provided, the valve loader 115 being used to load a valve or other medical device into the distal tip portion 107. Examples of such valve loader 115 are described in US serial numbers 12/249,243 and 12/422,179, each of which is incorporated herein in its entirety. The entire system 101 and valve loader 115 may be packaged together using packaging 118 and together form a kit 120.

Fig. 18A shows one possible use of the catheter system 101. Here, the catheter system 101 may be inserted into the working channel 511 of the bronchoscope 510. Bronchoscope 510 may be a commercially available model bronchoscope, such as BF-P180 manufactured by Olympus. Preferably, such bronchoscopes are provided with a working channel of at least 2.0mm, in addition to allowing the bronchoscope to maneuver into a visual path of the patient's trachea 601 leading to the lung 600. Of course, endoscopes other than bronchoscopes may be used for different procedures, and these are preferably provided with a working channel of at least 2.0 mm. Endoscopes (including bronchoscopes) used with system 101 are preferably no longer than 110cm in length.

Fig. 18B shows an alternative method of using the catheter system 101 in conjunction with a bronchoscope 510. Here, as shown, the grip 202 may be clipped onto a portion of the bronchoscope 510, wherein the bronchoscope is received within a recess of the grip 202. Some embodiments of the clip portion 202 may be configured to form a C-shaped handle, which may advantageously allow for a more secure connection with the bronchoscope. After the clip 202 is secured to the bronchoscope 510, the catheter shaft portion 105 and distal tip portion 107 are inserted into the working channel 511 of the bronchoscope 510. In some embodiments, it is advantageous to use a Tuohy-Borst adapter 515, as presently shown. Because the Tuohy-Borst adapter 515 helps secure the outer catheter sheath 316, precise placement of the device does not require a second person or other securing method to pinch or hold the catheter sheath during deployment.

19A-C illustrate the use and release of one embodiment of a latching mechanism that may be used in certain embodiments described herein. Fig. 19A presents an initial configuration of the handle portion 103, the system 101 preferably being subsequently provided to load a valve or other medical device therein. Here, the locking lever 210 is in a locked position, which in this embodiment occurs when the locking lever 210 extends distally relative to the securing tab 208. As shown in fig. 8 and described above, when the locking lever 210 is in this position, the locking tab 222 attached to the locking lever 210 engages the notch 220 on the movable handle 206, thereby reducing or eliminating the possibility of movement of the movable handle 206.

Fig. 19B shows the system 101 in an unlocked (but not deployed) position. Here, the locking lever 210 has been pushed towards the securing flap 208 by pivoting the locking lever 210 about the pivot point 226 in this case. When in this position, referring again to fig. 8, the locking tab 222 pivots or moves downward and disengages the notch 220 on the movable handle 206, thus allowing the movable handle 206 to slide axially in the proximal longitudinal direction toward the grip 202.

Fig. 19C shows the configuration of handle portion 103 after deployment of the device loaded in distal tip 107. Here, the movable handle 206 has been axially slid or moved in a proximal longitudinal direction towards the grip 202. Some embodiments may provide for the locking lever 210 to automatically return to the locked position. For example, after the movable handle 206 moves past the end of the locking tab 222, a spring or other restoring force may push or pivot the locking lever 210 back toward the locked position, such as via a spring 228 attached beneath the locking tab 222 (as shown in fig. 8). Accordingly, if the user slides the movable handle 206 back in the distal direction, the handle portion 203 will automatically reset to the configuration shown in FIG. 19A, thereby allowing deployment of another device without requiring the user to remember to reset the latch lever 210.

Fig. 20A-C illustrate an embodiment of a catheter system 101 with a valve 500 loaded into a lumen 405 in the distal tip portion 107. It is noted that some structural elements have been shown in phantom or not shown for clarity. The catheter system 101 has been inserted into a bronchoscope (not shown) that is introduced to the part of the lung requiring treatment, in this case the trachea 601.

In determining the appropriate deployment site for the valve 500 (represented here by deployment site 606), the operator may use line 445 to align the distal tip portion 107 with the site 606 where the valve is to be deployed, and the valve 500 will be released from the distal end 410 of the catheter at the approximate location represented by line 445. In some embodiments, the line 445 is generally aligned with the region of the airway against which the valve 500 will seal, and thus may be aligned with the intended deployment site 606. Lines 446, 447 flanking line 445 are preferably darker colored or colored in black to provide additional contrast to allow the operator to easily see line 445 through the bronchoscope viewing port. Again, in use, the operator may extend the catheter distally beyond the line 447 and then retract the catheter proximally until the line 445 is reached. Upon retraction, the first line 447 encountered may be used as a landmark, indicating that line 445 is approaching. If so provided, a long positioning marker 448 (as shown in FIG. 15) present on the distal portion of the catheter shaft portion 105 may also be advantageous as another safety feature to ensure that the operator does not extend the catheter too far beyond the bronchoscope.

When the line 445 is aligned with the desired deployment location 606, and the lock lever 210 is moved to its unlocked position, the operator pulls the movable handle 206 in a proximal direction toward the grip 202 (see generally fig. 19A-C). This deployment movement retracts the catheter shaft 302 and the cage 404 while the stabilizing wire 304 remains generally stationary. The pusher plunger 408 at the end of the stabilizing wire 304 is preferably configured to contact the central stem 502 of the valve 500 inserted in the cavity 405, thereby maintaining the valve 500 in substantially the same position as the cage 404 is retracted around the valve 500. After release from the catheter through the distal opening 410, the anchoring means of the valve 500 expands to contact the wall of the airway 601, and the valve 500 expands such that the apex of its cup portion generally comes into contact at a selected location 606 along the pulmonary trachea 601. This deployment method is useful because by aligning with line 445, it allows the device to be deployed to be in close proximity to the selected deployment site 606. Because the distal tip portion 107 is retracted around the device (e.g., valve 500), the device of the present invention can be more accurately positioned and deployed than prior art devices that merely eject the device from the distal end of the catheter.

Some embodiments of the catheter system 101 may also comply with certain benchmarks and specifications to perform acceptably in certain situations and applications. For example, in one embodiment where the system 101 is used to deploy a valve in the trachea, the system 101 would be partially inserted into the working channel 511 of the bronchoscope 510, as described above. Since bronchoscope 510 is inserted and navigated through the patient's tortuous trachea, system 101 therein must be able to flex sufficiently and withstand the forces to be applied thereto, including torsional, bending and kinking forces. Preferably, the system 101, in particular the catheter shaft portion 105, is configured to balance the following requirements: sufficient rigidity is required to transmit forces for navigating the system 101 to the appropriate deployment site, while being flexible enough to navigate through tortuous spaces and reduce the likelihood of damaging or penetrating the tracheal wall while extending through the bronchoscope working channel. In addition, the system 101 is preferably designed so that any possible failure of any component will not leave the component in the patient.

Since the system 101 is typically subjected to tension or pulling forces during operation, the distal tip portion 107 is preferably configured to remain attached to the catheter shaft portion 105 to reduce or eliminate the possibility of leaving certain portions within the patient. The distal tip portion 107 also preferably resists kinking of the cage 404 or other member, which can successfully deliver and deploy a medical device loaded therein.

As shown in fig. 19A-C and 20A-C, the embodiment of the system 101 is preferably configured such that its components minimize constraints and resistance to movement during insertion and manipulation in a bronchoscope, and during deployment of a device loaded into the distal tip portion 107. The exterior of the catheter shaft portion 105 and the distal tip portion 107 are preferably both configured to be relatively smooth, creating minimal friction, so that these components slide freely within the bronchoscope working channel. In addition, friction between the stabilization wire 304 and the interior of the catheter shaft 302 and/or distal tip portion 107 is preferably also minimized. Preferably, the force used to overcome the friction of a device (e.g., valve 500) loaded into lumen 405 of distal tip 107 should be less than the force that can be applied through handle portion 103 due to deployment of system 101 as discussed in FIGS. 19A-C and 20A-C. When configured in this manner, these embodiments can provide smoother, more accurate deployment of the device to the target site.

In use, a user inserts bronchoscope 510 into a patient's lungs for treatment with a device to be deployed from catheter system 101. Subsequently, catheter system 101 (with a device such as valve 500 already preloaded into lumen 405 of distal tip 107) is inserted into working channel 511 of bronchoscope 510. Referring now to fig. 19A-C, after selection and navigation to the appropriate deployment site, the locking lever 210 is moved to its unlocked position.

After confirming the location of the distal tip portion 107 with respect to the deployment site, which may include aligning the intended deployment site with any positioning indicia, such as a line 445 (shown in fig. 15), the user slides the sliding barrel 206 in a proximal direction toward the grip 202, thereby deploying the medical device (e.g., valve 500) at the deployment site at the patient's trachea.

In some embodiments, the accuracy of catheter device deployment may be improved by: an outer sheath 316 on the catheter shaft portion is pinched or otherwise secured to maintain the stabilization wire 304 in a relatively stationary position as the catheter shaft 302 is proximally withdrawn. In a preferred embodiment, catheter 101 can be removed from bronchoscope working channel 511 and movable handle 206 returned to its original position to reload another device. Thus, multiple device deployments may be performed within the trachea of a patient without the need to remove the bronchoscope 510 from the lungs 600 of the patient.

It should be understood that the presently illustrated catheter system 101 deployed into the lung is not limiting, and that the system 101 may be used to deploy different devices into other locations of a patient, including the stomach, an endoscope, or other suitable locations. Similarly, a bronchoscope is not required, and other suitable devices capable of housing system 101 and being guided to a deployed position may also be used, including, but not limited to, various endoscopic or laparoscopic cannulae.

Although the invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the scope of the invention encompasses not only the specifically disclosed embodiments, but also other alternative embodiments and/or uses of the invention and obvious modifications and equivalents. In addition, while several variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying forms or embodiments of the inventions disclosed herein. Therefore, it should be noted that the scope of the invention disclosed herein is not to be limited by the particular disclosed embodiments described above.

Claims (17)

1. A deployment catheter for deploying a device into a lung, the deployment catheter comprising:
a proximal end comprising a handle portion comprising a plunger surrounded by a movable handle configured to slide axially in a direction along at least a portion of a length of the plunger, and wherein the plunger further comprises a locking lever switchable between a locked position and an unlocked position, the locking lever configured to prevent the movable handle from sliding in the proximal direction toward the plunger when in the locked position, but to allow the movable handle to slide in the proximal direction when in the unlocked position, and wherein the locking lever is further configured to reset to the locked position;
a catheter shaft portion comprising a catheter shaft and a stabilizing wire inside the catheter shaft, wherein the catheter shaft is fixed to the movable handle at a proximal end of the catheter shaft, and wherein the stabilizing wire is fixed to the plunger; and
a distal tip portion configured to receive a medical device in a lumen, wherein the distal tip portion is secured to the distal end of the hollow catheter shaft, and further comprising an advancer plunger received in the lumen, the advancer plunger being connected to the distal end of the stabilizing wire;
wherein a C-handle is attached to the plunger at a proximal end of the plunger and the C-handle is fixed to a bronchoscope, the catheter shaft portion and the distal tip portion being inserted into a working channel of the bronchoscope, and wherein in the unlocked position the movable handle is allowed to move in a proximal direction towards the C-handle.
2. The deployment catheter of claim 1, wherein said locking lever is attached to a plunger at a distal end of a movable handle.
3. The deployment catheter of claim 1, wherein the locking lever comprises a spring attached to the locking lever, the spring configured to return the locking lever to a locked position after the medical device has been deployed from the deployment catheter.
4. The deployment catheter of claim 1, wherein said catheter shaft portion comprises a highly flexible region at a distal end thereof.
5. The deployment catheter of claim 4, wherein said high flexibility region is a dog-staggered form configuration.
6. The deployment catheter of claim 4, wherein said high flexibility region is a serpentine-type configuration.
7. The deployment catheter of claim 4, wherein said high flexibility regions comprise overlapping discontinuous linear cuts.
8. The deployment catheter of claim 1, wherein said distal tip portion comprises a cage with at least one lumen configured to receive a medical device.
9. The deployment catheter of claim 8, wherein said cage has an arrangement of struts forming a helical configuration.
10. The deployment catheter of claim 8, wherein said cage comprises one or more large fenestrations.
11. The deployment catheter of claim 10, wherein said one or more large fenestrations are configured to allow visualization and confirmation that the medical device has been loaded into the lumen.
12. The deployment catheter of claim 1, wherein said distal tip portion comprises at least one positioning marker configured to indicate an approximate deployment position of said medical device.
13. The deployment catheter of claim 12, wherein said positioning marker is yellow, with two additional black bands on either side.
14. The deployment catheter of claim 1, wherein the distal end of said catheter shaft portion further comprises at least one elongated positioning marker.
15. The deployment catheter of claim 1, wherein said handle portion further comprises a frustoconical strain relief surrounding a proximal region of said catheter shaft portion.
16. The deployment catheter of claim 1, further comprising an outer sheath surrounding at least a proximal region of said catheter shaft portion.
17. The deployment catheter of claim 1, wherein said deployment catheter is configured to be loaded into a bronchoscope.
CN201610855500.2A 2011-05-13 2011-05-13 Deployment catheter CN106333749B (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN2011800024509A CN102970945A (en) 2011-05-13 2011-05-13 Deployment catheter
PCT/US2011/036549 WO2012158152A1 (en) 2011-05-13 2011-05-13 Deployment catheter
CN201610855500.2A CN106333749B (en) 2011-05-13 2011-05-13 Deployment catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610855500.2A CN106333749B (en) 2011-05-13 2011-05-13 Deployment catheter

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN2011800024509A Division CN102970945A (en) 2011-05-13 2011-05-13 Deployment catheter

Publications (2)

Publication Number Publication Date
CN106333749A CN106333749A (en) 2017-01-18
CN106333749B true CN106333749B (en) 2020-01-03

Family

ID=47177224

Family Applications (3)

Application Number Title Priority Date Filing Date
CN2011800024509A CN102970945A (en) 2011-05-13 2011-05-13 Deployment catheter
CN201610855500.2A CN106333749B (en) 2011-05-13 2011-05-13 Deployment catheter
CN2012200373342U CN202723895U (en) 2011-05-13 2012-02-06 Unfolded catheter

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN2011800024509A CN102970945A (en) 2011-05-13 2011-05-13 Deployment catheter

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN2012200373342U CN202723895U (en) 2011-05-13 2012-02-06 Unfolded catheter

Country Status (5)

Country Link
JP (1) JP6026513B2 (en)
CN (3) CN102970945A (en)
DE (1) DE112011105242T5 (en)
GB (1) GB2511375B (en)
WO (1) WO2012158152A1 (en)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030050648A1 (en) 2001-09-11 2003-03-13 Spiration, Inc. Removable lung reduction devices, systems, and methods
US6592594B2 (en) 2001-10-25 2003-07-15 Spiration, Inc. Bronchial obstruction device deployment system and method
US6866679B2 (en) 2002-03-12 2005-03-15 Ev3 Inc. Everting stent and stent delivery system
US20030181922A1 (en) 2002-03-20 2003-09-25 Spiration, Inc. Removable anchored lung volume reduction devices and methods
US20030216769A1 (en) 2002-05-17 2003-11-20 Dillard David H. Removable anchored lung volume reduction devices and methods
US7533671B2 (en) 2003-08-08 2009-05-19 Spiration, Inc. Bronchoscopic repair of air leaks in a lung
US7691151B2 (en) 2006-03-31 2010-04-06 Spiration, Inc. Articulable Anchor
US20100191168A1 (en) 2009-01-29 2010-07-29 Trustees Of Tufts College Endovascular cerebrospinal fluid shunt
US20130226278A1 (en) 2012-02-23 2013-08-29 Tyco Healthcare Group Lp Methods and apparatus for luminal stenting
US9072624B2 (en) 2012-02-23 2015-07-07 Covidien Lp Luminal stenting
US9078659B2 (en) 2012-04-23 2015-07-14 Covidien Lp Delivery system with hooks for resheathability
US9724222B2 (en) 2012-07-20 2017-08-08 Covidien Lp Resheathable stent delivery system
CN106691630A (en) * 2013-03-14 2017-05-24 斯波瑞申有限公司 Valve loading method, system, and apparatus
US10130500B2 (en) 2013-07-25 2018-11-20 Covidien Lp Methods and apparatus for luminal stenting
US9782186B2 (en) 2013-08-27 2017-10-10 Covidien Lp Vascular intervention system
US10265207B2 (en) 2013-08-27 2019-04-23 Covidien Lp Delivery of medical devices
US10448862B2 (en) 2013-09-06 2019-10-22 Covidien Lp System and method for light based lung visualization
US10098566B2 (en) 2013-09-06 2018-10-16 Covidien Lp System and method for lung visualization using ultrasound
US10201265B2 (en) 2013-09-06 2019-02-12 Covidien Lp Microwave ablation catheter, handle, and system
JP6461159B2 (en) * 2013-09-06 2019-01-30 コビディエン エルピー Microwave ablation catheter, handle, and system
JP6196110B2 (en) * 2013-09-25 2017-09-13 テルモ株式会社 Long member for medical use
US9737696B2 (en) 2014-01-15 2017-08-22 Tufts Medical Center, Inc. Endovascular cerebrospinal fluid shunt
JP6586172B2 (en) 2014-10-31 2019-10-02 セレバスク,エルエルシーCereVasc,LLC Method and system for treating hydrocephalus
WO2017004194A1 (en) * 2015-06-30 2017-01-05 Boston Scientific Scimed, Inc. Medical device having outer polymeric member including one or more cuts
WO2017021993A1 (en) * 2015-07-31 2017-02-09 マルホ発條工業株式会社 Slit pipe and medical-treatment shaft member in which same is used
EP3368137A1 (en) 2015-10-30 2018-09-05 Cerevasc, LLC Systems and methods for treating hydrocephalus
WO2018160966A1 (en) * 2017-03-02 2018-09-07 Cerevasc, Llc Catheter systems and methods for medical procedures using catheters
US10376396B2 (en) 2017-01-19 2019-08-13 Covidien Lp Coupling units for medical device delivery systems
US20180303609A1 (en) * 2017-04-19 2018-10-25 Medtronic Vascular, Inc. Catheter-based delivery device having segment with non-uniform width helical spine
WO2019146086A1 (en) * 2018-01-26 2019-08-01 朝日インテック株式会社 Catheter
WO2019146088A1 (en) * 2018-01-26 2019-08-01 朝日インテック株式会社 Catheter

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4995872A (en) * 1989-10-04 1991-02-26 Ferrara Janice J Expandable catheter and bridge device
JPH10503411A (en) * 1995-05-25 1998-03-31 メドトロニック・インコーポレーテッド Stent assembly and method of using the same
US7879022B2 (en) * 1998-02-06 2011-02-01 Medrad, Inc. Rapid exchange fluid jet thrombectomy device and method
US6602280B2 (en) * 2000-02-02 2003-08-05 Trivascular, Inc. Delivery system and method for expandable intracorporeal device
WO2003004086A2 (en) * 2001-07-05 2003-01-16 Precision Vascular Systems, Inc. Troqueable soft tip medical device and method of usage
US20050080434A1 (en) * 2003-10-08 2005-04-14 Cedars-Sinai Medical Center Laparoscopic retractable dissector and suture and needle passer
EP1656963B1 (en) * 2004-11-10 2007-11-21 Creganna Technologies Limited Stent delivery catheter assembly
AU2007261046A1 (en) * 2006-06-20 2007-12-27 Aortx, Inc. Torque shaft and torque drive
AU2008299144B2 (en) * 2007-09-12 2011-11-24 Transluminal Technologies, Llc Closure device, deployment apparatus, and method of deploying a closure device
US8043301B2 (en) * 2007-10-12 2011-10-25 Spiration, Inc. Valve loader method, system, and apparatus
US8114144B2 (en) * 2007-10-17 2012-02-14 Abbott Cardiovascular Systems Inc. Rapid-exchange retractable sheath self-expanding delivery system with incompressible inner member and flexible distal assembly
EP2845569A1 (en) * 2008-10-01 2015-03-11 Cardiaq Valve Technologies, Inc. Delivery system for vascular implant

Also Published As

Publication number Publication date
WO2012158152A1 (en) 2012-11-22
GB201318950D0 (en) 2013-12-11
CN106333749A (en) 2017-01-18
DE112011105242T5 (en) 2014-03-06
CN102970945A (en) 2013-03-13
JP2014519376A (en) 2014-08-14
JP6026513B2 (en) 2016-11-16
GB2511375B (en) 2017-07-26
CN202723895U (en) 2013-02-13
GB2511375A (en) 2014-09-03

Similar Documents

Publication Publication Date Title
US20170209668A1 (en) Intravenous Catheter And Insertion Device With Reduced Blood Spatter
US20160262932A1 (en) Probes For Use In Ophthalmic And Vitreoretinal Surgery
JP6114766B2 (en) Expandable transluminal sheath
US10076316B2 (en) Needle biopsy device
US20190183471A1 (en) Adapter for Attaching Devices to Endoscopes
EP2667792B1 (en) Systems for sealing a tissue wall puncture
JP5587981B2 (en) Medical system, device and method for suturing perforations
US7896861B2 (en) Catheter with a pre-shaped distal tip
JP5728023B2 (en) Endoscope cap with an inclined part
US8454536B2 (en) Guide wire advancer assembly and methods for advancing a guide wire
ES2271105T3 (en) Medical use clamping device.
AU2003282886B2 (en) Stent delivery system and method of use
US5316543A (en) Medical apparatus and methods for treating sliding hiatal hernias
US20160000451A1 (en) Medical retrieval devices
EP1100381B1 (en) Devices for the repair of arteries
JP5090600B2 (en) Improved device for accurately marking tissues
US8267987B2 (en) Medical appliance delivery apparatus and method of use
JP2018140198A (en) Rapid exchange stent delivery system
CA2656388C (en) Suction clip
US7798995B2 (en) Adjustable tip needle apparatus
JP4477382B2 (en) Endoscopic intraperitoneal treatment system
US8328841B2 (en) Embolization coil delivery systems and methods
DE602004005116T2 (en) Introducer device for a trocar
DE69732965T2 (en) Medical multiple instrument with spring device
US8784304B2 (en) Over-tube, method of manufacturing over-tube, method of disposing over-tube, and method of treatment in abdominal cavity

Legal Events

Date Code Title Description
PB01 Publication
C06 Publication
SE01 Entry into force of request for substantive examination
C10 Entry into substantive examination
GR01 Patent grant
GR01 Patent grant
TR01 Transfer of patent right

Effective date of registration: 20200522

Address after: Massachusetts, USA

Patentee after: Jieruishi Co., Ltd

Address before: Washington State

Patentee before: SPIRATION, Inc.

TR01 Transfer of patent right