Valve Loader Method, System, and Device

Abstract

A valve loading system uses a valve loader to convey a valve or other medical device from a storage cartridge into a deployed catheter. After the valve or other medical device has been compressed and loaded into the catheter using the valve loader, the valve or other medical device can be implanted or positioned within a patient using the catheter. The process can then be repeated by loading or introducing another valve or other medical device into the catheter using the valve loading system. The valve loading system includes a loading pin sized to limit contact with the medical device during loading.

Description

Background Art

[0001] A catheter is a tube that can be inserted into the body or into a body cavity, duct, or blood vessel. A range of polymers - including but not limited to silicone, rubber, latex, polyurethane, nylon, Pebax, and thermoplastic elastomers - are used to construct catheters. Silicone is one of the most common choices because silicone is generally inert and typically does not react with the body fluids and a range of medical liquids with which it may come into contact. Catheters can be used to allow the guiding or injection of liquids into the body, or to intervene in the body through surgical instruments and / or implantable devices. In order for a catheter to access the body, the implantable device must be inserted into the catheter. Summary of the Invention

[0002] Embodiments of the present invention generally relate to loader devices, systems, and methods for loading and / or introducing valves or other medical devices for implantation into the body into a catheter. In certain embodiments, the medical devices, systems, and methods allow the catheter to be loaded or introduced with multiple valves or other medical devices.

[0003] For purposes of overview, certain aspects, advantages, and novel features of the present invention are described herein. It should be understood that it is not necessary to employ and / or implement all of these aspects, advantages, and features in any particular embodiment of the present invention. Thus, for example, those skilled in the art will recognize that the present invention may be practiced or carried out in a manner that achieves one advantage or a set of advantages taught herein, without necessarily achieving other advantages taught or suggested herein. Brief Description of the Drawings

[0004] The foregoing and other features, aspects, and advantages of the present invention are described in detail below with reference to the drawings of different embodiments, which are intended to illustrate rather than limit the present invention. The drawings include the following figures, wherein:

[0005] Figure 1 is a system diagram of an embodiment of a valve loading system for loading and / or introducing a valve or other medical device into an arranged catheter or other arranged device.

[0006] Figure 2 is Figure 1 a perspective view of an embodiment of a valve loader of the system for loading and / or introducing a valve or other medical device into an arranged catheter or other arranged device.

[0007] Figure 3 is Figure 2 a sectional view of the valve loader.

[0008] Figure 4 is Figure 2 an exploded perspective view of the valve loader.

[0009] Figure 5 is Figure 2 Another exploded perspective view of the valve loader.

[0010] Figure 6 is Figure 1 A cross-sectional view of the system components, which shows the state where an embodiment of the valve loader is combined with an embodiment of the cartridge and an embodiment of the medical device to be loaded into an embodiment of a catheter or other deployment device.

[0011] Figure 7 is the valve loader loaded within the cartridge, and Figure 6 the medical device is loaded into Figure 2 a cross-sectional view of the state of the loader.

[0012] Figure 8 is Figure 2 An enlarged perspective view of the valve loader after specific components are removed.

[0013] Figure 9 is Figure 2 A cross-sectional view of the plunger and locking mechanism of the valve loader.

[0014] Figure 10 is Figure 2 A partially enlarged cross-sectional view of the valve loader.

[0015] Figure 11 is Figure 2 Another partially enlarged cross-sectional view of the valve loader.

[0016] Figure 12 is together with Figure 2 A perspective view of the cartridge used with the valve loader.

[0017] Figure 13 is Figure 12 Another perspective view of the cartridge.

[0018] Figure 14 is Figure 12 A front view of the cartridge.

[0019] Figure 15 is Figure 12 Another front view of the cartridge with the lid removed.

[0020] Figure 16 is Figure 12 A rear view of the cartridge.

[0021] Figure 17 is Figure 12 A top view of the cartridge.

[0022] Figure 18 is Figure 12Bottom view of the box.

[0023] Figure 19 is Figure 12 Left side view of the box.

[0024] Figure 20 is Figure 12 Right side view of the box.

[0025] Figure 21 is Figure 12 Sectional perspective view of the box.

[0026] Figure 22 is in Figure 1 Perspective view of an embodiment of an arrangement conduit or other arrangement device used in the system.

[0027] Figure 23 is Figure 22 Side view of the arrangement conduit or other arrangement device.

[0028] Figure 24 is for Figure 23 taken at circle 24 in Figure 23 Enlarged view of the distal end of the arrangement conduit or other arrangement device.

[0029] Figure 25 is a sectional view taken along Figure 24 line 25 - 25, which shows Figure 22 the distal end of the arrangement conduit or other arrangement device.

[0030] Figure 26 is Figure 22 Enlarged perspective view of the control part of the arrangement conduit or other arrangement device.

[0031] Figure 27 is the first section taken through Figure 22 the arrangement conduit or other arrangement device.

[0032] Figure 28 is the second section taken at approximately 90 degrees to the first section shown in Figure 27 [description of the figure].

[0033] Figure 29 is a sectional view of the valve loader inside the box and Figure 6 the medical device is loaded into Figure 2 the valve loader.

[0034] Figure 30 is Figure 29 Stereo cross-sectional view of the box and perspective view of the loader pin and conduit.

[0035] Figure 31 is Figure 30Stereoscopic cross-sectional view of a part of the cartridge and a stereoscopic view of the loader pin. Detailed Description

[0036] Reference is now made to the drawings of one or more embodiments to describe a valve loading system and related components. The terms used in the present specification are not intended to be construed in any limiting or restrictive manner. Rather, the terms are used only in conjunction with a detailed description of embodiments of the system, method, and related components. Additionally, an embodiment may include some novel features, and any single one of these novel features may not alone determine its desired properties or be considered essential for achieving the present invention.

[0037] As used herein, the terms "valve", "deployable medical device", and "medical device" are broad and interchangeable terms, and unless otherwise indicated, the meaning of these terms may non-restrictively include stents, valves, lung volume reduction valves, coils, filters, embolic protection devices, inflatable balloons, augmentation devices, probes, anchors, sponges, or any other medical device (deployable or otherwise) configured to be loaded or introduced into a catheter or other deployment device. In a particular embodiment, the valve and / or medical device is of the type disclosed in U.S. Patent No. 6,293,951 or U.S. Patent Application Publication No. 2003-0050648, both of which are hereby incorporated by reference in their entirety.

[0038] In a particular embodiment, the valve loading system described herein may be configured to load valves or medical devices as small as about 5 mm, 6 mm, 7 mm, and 9 mm in diameter. In a particular embodiment, the valve loading system may be configured to use a bronchoscope having a working channel diameter of about 2.0 mm or greater (e.g., about 2.6 mm) to compress or collapse the valve or medical device for deployment. In a particular embodiment, the valve or medical device includes a radiopaque material that is visible through the deployment catheter or other deployment device, bronchoscope, or body.

[0039] As used herein, the terms "body" and "patient" are broad and interchangeable terms that generally refer to the body of a mammal (human or animal), patient, organ, lumen, cavity, blood vessel, passage, channel, etc.

[0040] As described above, 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 device. In some embodiments, a valve loading system is provided that generally but non - restrictively includes: a deployment catheter or other deployment device, a valve loader, a valve - carrying cassette (also referred to herein as a replaceable medical device cassette), and / or other components. After the valve or other medical device has been loaded into the catheter or other deployment device using the valve loader, the catheter or other deployment device can be used to load or position the valve or other medical device within a patient. In some embodiments, the process can be repeated by loading or introducing another valve or other medical device into the catheter (the term "catheter" as used herein non - restrictively includes any other deployment device) using the valve loading system.

[0041] Figure 1 An embodiment of a valve loading system 100 arranged and configured in accordance with specific features, aspects, and advantages of the present invention is shown. The illustrated valve loading system 100 generally includes a deployment catheter 102, a cassette 104, and a valve loader 106. The cassette 104 carries, transports, and / or stores a valve or other medical device. In some configurations, the cassette 104 is designed to store a valve or other medical device for a limited time or for a longer period. In some embodiments, the cassette 104 is replaceable with another cassette. The valve loader can include a first open cavity 214 that receives the cassette 104. With the cassette 104 positioned within the cavity 214 and the distal end 112 of the deployment catheter 104 positioned within the connection port 108, the valve loader 106 can be used to transport a valve or other medical device from the cassette 104 to the deployment catheter 102. Thus, the illustrated valve loader 106 can be configured to provide a sterile loading of a valve or other medical device into the deployment catheter 102.

[0042] The illustrated valve loader 106 includes an outer housing structure 202. In some embodiments, the outer housing structure 202 is constructed of plastic, metal, or other similar materials. Preferably, the outer housing structure 202 is sized and configured to be held in a hand. In some embodiments, the outer housing structure 202 can have a length that allows for easy placement in a user's hand. For example, the length of the outer housing structure 202 can be 5, 6, 7, or 8 inches, which is easily adaptable to fit within a user's hand. The outer housing structure 202 can include a generally cylindrical shape or other suitable form to enhance ergonomics and make it easy to place in a person's hand or be controlled by a person's hand. In the illustrated configuration, the outer housing structure 202 includes a flattened cylindrical shape. Other structures, materials, shapes, and sizes are also possible.

[0043] As Figure 1 and Figure 2As shown, the housing structure 202 may have a top side 204, a bottom side 206, a proximal end 208, and a distal end 210. Any directional terms used herein provide only a reference frame and should not be considered as limiting the scope of the present invention. As used herein, "distal" refers to the position toward which the valve or other medical device will be disposed, and "proximal" refers to the user of the component (e.g., the user of the valve loader 106).

[0044] The outer housing structure 202 preferably has a plurality of depressions 212 along the top side 204 and the bottom side 206. The outer housing structure 202 shown includes two depressions 212 along the top side 204 and four depressions 212 along the bottom side 206. In some embodiments, two of the depressions 212 along the top side 204 are generally aligned with two of the four depressions 212 along the bottom side 206. Preferably, the two depressions 212 are disposed at opposite ends of the top side 204. More preferably, the two depressions 212 on the top side 204 are disposed such that one of the two depressions 212 is on each side of a first open cavity 214.

[0045] The first open cavity 214 may have any suitable configuration. In some embodiments, the first open cavity 214 includes a generally rectangular shape with an angled portion 216; however, other shapes and sizes are possible. In a particular embodiment, the shape and configuration of the first open cavity 214 correspond to the outer shape and configuration of the cartridge 104 such that the cartridge 104 can be inserted into the first open cavity 214 in only one direction, orientation, or position. In other words, the cavity 214 of the housing 202 may include a first shape and the cartridge 104 may include a complementary shape such that when the cartridge 104 is inserted into or coupled with the housing 202, the cartridge 104 is properly oriented for its intended use.

[0046] Reference Figure 1 and Figure 2 and, the housing structure 202 may include a connection port 108 partially defined by a second open cavity 218 that may receive the distal end 112 of the deployment catheter 102 or other device, such as a shipping lock 114. In some embodiments, the proximal end of the shipping lock 114 may be shaped and configured to closely correspond to the shape and configuration of the distal end 112 of the deployment catheter 102. Although the housing structure 202 shown includes a second open cavity 218, the housing structure 202 may include a generally flat distal end 210 or a protruding distal end 210, and the second open cavity 218 includes a funnel-shaped configuration that aids in receiving the distal end 112 of the deployment catheter 102.

[0047] The housing structure 202 of the valve loader 106 can be composed of two halves or sides 202A, 202B that are fixed together in any suitable manner. In some configurations, the two parts 202A, 202B are snapped together and can be fixed together with posts or the like. Preferably, one of the two parts 202B is considered the convex part and the other part 202A of the two parts is considered the concave part, and the convex part and the concave part can be joined together in any suitable manner.

[0048] In a particular embodiment and as Figure 3 and Figure 4 best shown, the housing structure 202 defines one or more inner chambers containing a plurality of components, the plurality of components including but not limited to a loader plunger 220 (also referred to herein as an actuator), a cartridge locking mechanism 222, an alignment insert 224, an alignment tube 226, and first and second jaws 228A and 228B.

[0049] Reference Figure 4 and Figure 5, the loader plunger or actuator 220 is configured to slide within the illustrated housing structure 202 along the axial center of the housing structure. In a particular embodiment, the loader plunger or actuator 220 is configured to be screwed or turned into the housing structure 202 along the axial center of the housing structure 202. In a particular embodiment, the housing structure 202 includes a stop device to signal or indicate to the user when the plunger or actuator 220 has traveled to the correct position in the housing for fully loading the valve or medical device into the deployment catheter or device. In a particular embodiment, the cartridge 104 includes a lid, cap, or cover 422 with a thicker tab 431 to serve as a stop device to signal or indicate to the user when the plunger or actuator 220 has traveled to the correct position in the housing for fully loading the valve or medical device into the deployment catheter or device. In a particular embodiment, the length, shape, and / or size of the thicker tab 431 are changed to determine how far the plunger or actuator 220 can enter the housing, thereby affecting the position of the valve or medical device in the deployment catheter or device. In a particular embodiment, the lid, cap, or cover 422 can be positioned flush with the outer surface of the cartridge 104, or the lid, cap, or cover 422 can be positioned (at different depths) inset from the outer surface of the cartridge 104 to determine how far the plunger or actuator 220 can enter the housing, thereby affecting the position of the valve or medical device in the deployment catheter or device. In a particular embodiment, the cartridge 104 includes a lid, cap, or cover 422 with teeth or thinner tabs 430 that provide an audible indication that the plunger or actuator 220 has traveled to the correct position in the housing for fully loading the valve or other medical device into the deployment catheter or device. As Figure 5 shown, the loader plunger or actuator 220 can have an axial slot 230 that extends along at least a portion of the loader plunger 220. The axial slot 230 preferably terminates adjacent the distal end of the loader plunger 220. The distal end of the axial slot 230 preferably terminates within another slot 232 that extends diagonally across the axial slot 230 (see Figure 4 ).

[0050] As Figure 4 , 5 and as shown in 6, a cartridge locking mechanism 222 (also referred to herein as a safety device) can be disposed within the housing structure 202. The illustrated cartridge locking mechanism 222 includes a generally "U" - shaped configuration, etc., that includes a first end 234 and a second end. The first end 234 of the illustrated cartridge locking mechanism 222 is supported by and / or coupled to a pivot pin 236, and the balance portion of the locking mechanism 222 is allowed to rotate or swing or move about the pivot pin.

[0051] As Figure 5 and Figure 9 shown, the locking mechanism 222 includes a first nub 238 and a second nub 240. In the illustrated configuration, the first nub 238 and the second nub 240 face the convex half 202A of the illustrated outer housing 202. The first nub 238 is slightly larger than the second nub 240, and the shape and orientation of the first nub 238 generally correspond to the shape and orientation of the slot 232. The first nub 238 is separated from the second nub 240 by a distance that can accommodate at least one of the surfaces extending axially along the axial slot 230. Additionally, the second nub 240 is sized such that it can be received within the axial slot 230, while the first nub 238 is sized such that it cannot be received within the axial slot 230.

[0052] Thus, as the loader plunger 220 is pushed into the housing structure 202, the locking mechanism 222 rotates slightly as the first nub 238 moves within the generally diagonal slot 232 until the second nub 241 aligns with the axial slot 230. When the locking mechanism 222 has rotated and the second nub 240 is aligned with the axial slot 230, further advancing the loader plunger 220 into the housing structure 202 causes the loader plunger 220 to move distally, and the second nub 240 to move axially along the axial slot 232. During this continuous movement, the locking mechanism is fixed against rotation since the second nub 240 is disposed within the axial slot 230.

[0053] Similarly, as the loader plunger is withdrawn from the housing structure 202, the axial slot 230 moves relative to the second nub 240 until the second nub 240 reaches the diagonal slot 232. When the second nub 240 reaches the diagonal slot 232, the second nub 240 slides within the diagonal slot, which causes the locking mechanism 222 to rotate. The rotation of the locking mechanism 222 drags the first nub 238 into the diagonal slot 232. After the first nub 238 is disposed within the diagonal slot 232, the first nub 238 stops the loader plunger 220 from being further withdrawn from the outer housing structure 202.

[0054] Referring Figure 8 , the locking mechanism 222 further includes a first stop device 242 and a second stop device 244. The rotational movement of the locking mechanism 222 is limited by the first stop device 242 and the second stop device 244 in the illustrated configuration. The first stop device 242 moves to abut against the first surface 246 of the housing structure 202 during rotation in a first direction (i.e., upward or clockwise), and the second stop device 244 moves to abut against the second surface 248 of the housing structure 202 during rotation in a second direction (i.e., downward or counterclockwise). Other configurations may also be used to limit the range of rotational movement of the locking mechanism 222.

[0055] As described above, the illustrated locking mechanism 222 also includes a second end portion 250. The second end portion extends through an opening 252 leading to the first open cavity 214. The second end portion 250 of the cartridge locking mechanism 222 serves as an arm or a bracket or a rod that secures the cartridge 104 within the first open cavity 214 of the housing structure 202, or reduces the likelihood of inserting the cartridge 104 into the first open cavity 214 in the event that the loader plunger 220 is not fully retracted from the housing structure 202. As such, the locking mechanism 222 protects the plunger 220 from damage caused by inserting or removing the cartridge 104 in the event that the plunger 220 is not fully retracted from the first open cavity 214 or the cartridge 104. As the locking mechanism 222 rotates, pivots or moves towards the first open cavity 214 of the housing structure 202, the arm, bracket or rod of the second end portion 250 passes through the opening 252 and into or into the first open cavity 214 of the housing structure 202. If the cartridge 104 is located within the first open cavity 214, the arm, bracket or rod of the second end portion 250 may engage with the first open cavity 214, or may lock the cartridge 104 into the first open cavity 214. As the loader plunger 220 is pulled out of the housing structure 202, the cartridge locking mechanism 222 rotates, pivots or moves the cartridge locking mechanism 222 away from the first open cavity 214 of the housing structure 202, thereby allowing the arm, bracket or rod of the second end portion 250 to be removed or substantially removed from the first open cavity 214 of the housing structure 202, and unlocking or disengaging the cartridge 104 if the cartridge is located within the first open cavity 214.

[0056] Reference Figure 10 and Figure 11 , the alignment insert 224 generally defines a passageway 252. At least a portion of the passageway 252 decreases in diameter from the proximal end of the portion to the distal end of the portion. In some embodiments, the diameter decreases from the proximal end of the alignment insert 224 to a midpoint position of the alignment insert 224. Other configurations are possible.

[0057] Although the external structure of the alignment insert 224 may have any suitable configuration, the illustrated configuration includes a generally cylindrical proximal end 254 and a generally cylindrical proximal end 256 of smaller diameter. Preferably, the proximal end 254 of the alignment insert 224 is positioned such that its proximal surface is generally flush with the surrounding or adjacent surface of the first open cavity 214.

[0058] The alignment insert 224 can be disposed within the housing structure 202 and can be configured to guide and / or compress a valve or medical device 704 into a compressed state for insertion or placement of the deployment catheter 102. The alignment insert 224 can be constructed of plastic, metal, or other similar materials. In the illustrated configuration, the proximal end 254 includes two or more fins 258. The fins 258 can be disposed within recesses formed in the outer housing 202. Thus, the fins 258 can help to properly position the alignment insert 224 within the outer housing 202 and limit axial movement of the alignment insert 224 relative to the outer housing 202.

[0059] The passageway 252 defined by the alignment insert 224 is preferably axially aligned with the passageway 260 defined by the alignment tube 226. The passageway 260 includes a generally cylindrical proximal portion 262, a tapered or funnel-shaped channel 264, a generally cylindrical portion 266 of smaller diameter, another generally cylindrical portion 268 of slightly larger diameter, and a slightly expanded portion 270. The passageway also includes a generally cylindrical distal portion 272 and a distal portion 274 configured to be generally conical.

[0060] The portion 266 of smaller diameter is preferably smaller than the outer diameter of the catheter (for which the loader 106 is designed to be used with), while the portion 268 of slightly larger diameter is slightly larger than the above outer diameter. Accordingly, during insertion, the distal end of the deployment catheter 102 can abut against a step defined between these two portions 266, 268.

[0061] The generally cylindrical proximal portion 262 of the alignment tube 226 is preferably sized and configured to receive the distal end 256 of the alignment insert 224. As shown, the distal-facing surface of the proximal end 254 of the alignment insert 224 can include a shallow channel 276, and the proximal-facing proximal surface of the proximal end of the alignment tube 226 can be provided with a deeper channel 278.

[0062] A spring 280 or the like can be disposed such that the proximal end is within the shallow channel 276 of the alignment insert 224 and the distal end is within the deeper channel 278 of the alignment tube 226. The spring 280 or other biasing member advantageously biases the alignment insert 224 and the alignment tube 226 apart. Since the alignment insert 224 is generally axially fixed relative to the outer housing 202 by the fins 258, the alignment tube 226 can axially move relative to the outer housing 202 and can be biased by the spring 280 to a first position, which can be defined by features of the surrounding portion of the outer housing 202.

[0063] The alignment tube 226 can be constructed of plastic, metal, or other similar materials. In a particular embodiment, the alignment tube 226 has a generally rectangular outer shape (however, other shapes and configurations are feasible without departing from the spirit of the embodiment).

[0064] The alignment tube 226 preferably has an opening 282. The illustrated opening 282 is generally vertical. Preferably, the opening 282 extends through the central portion of the illustrated alignment tube 226. The opening 282 is configured to receive the first jaw 228A and the second jaw 228B on either side thereof. In a particular embodiment, the opening 282 has a rectangular shape, but other shapes and configurations are also possible. The alignment tube 226 also preferably includes first and second external posts 284. The posts 284 extend laterally outward from the lateral surface of the alignment tube 226. Preferably, the posts 284 are located on each lateral side of the opening 282 such that the axial position of the posts 284 is between the proximal and distal ends of the opening 282. Other configurations are possible.

[0065] The first jaw 228A and the second jaw 228B are preferably constructed of plastic, rubber, polymer, or other similar materials. The first jaw 228A may be generally located above the alignment tube 226, while the second jaw 228B may be generally located below the alignment tube 226. Each jaw 228A, 228B may include first ends 286A, 286B that are supported and / or coupled to respective pivot pins 288A, 228B by the respective pivot pins 288A, 228B, and the pivot pins 288A, 228B are connected to the housing structure 202. Thus, the jaws 228A, 228B are allowed to swing or rotate about the pivot pins 288A, 228B. Each jaw 228A, 228B may also have second ends 290A, 290B.

[0066] The second ends 290A, 290B in the illustrated configuration each include clamping portions 292A, 292B and surrounding portions 294A, 294B. The clamping portions 292A, 292B may be configured to be at least partially inserted into the opening 282 of the alignment tube 226, and the surrounding portions 294A, 294B may be configured to at least partially surround the outer surface of the alignment tube 226. More preferably, the surrounding portions 294A, 294B abut the posts 284 of the alignment tube 226. Even more preferably, the mounting recesses 296A, 296B formed in the surrounding portions 294A, 294B abut the posts 284 of the alignment tube 226, and the mounting recesses 296A, 296B are offset in the distal direction relative to the axis of rotation defined by the pins 288A, 288B. The slight offset of the position of the recesses 296A, 296B relative to the axis of rotation defined by the pins 288A, 288B causes the alignment tube 226 to snap into the first position following any slight displacement in the proximal direction.

[0067] In a default or normal position, the jaws 228A, 228B can be substantially perpendicular to the alignment tube 226. When the second ends 290A, 290B of the first and second jaws 228A, 228B are disposed within the alignment tube 226, the first clamping portion 300A and the second clamping portion 300B come together and form a generally cylindrical or tubular region or clamp that is configured to grip, hold, retain, lock, and / or clamp the disposed conduit 102 within the alignment tube 226.

[0068] The first and second clamping portions 300A, 300B include vertices, sharp features, or ribs 302. As shown, the ribs 302 are preferably configured to define a larger inner diameter at the proximal and distal ends and a smaller inner diameter at the middle. Thus, as the jaws 228A, 228B rotate in the proximal direction, when the jaws 228A, 228B rotate back towards the starting position (i.e., the first position corresponding to the insert tube 226), the diameter defined by the ribs that are generally orthogonal to each other is larger than the diameter defined by the intermediate, generally orthogonal ribs.

[0069] Accordingly, in the starting position, the central ribs of the ribs 302 cooperate with each other to hold the end of the disposed conduit, and once rotated in the proximal direction from the starting position, the larger ribs cooperate together and define a larger diameter such that the disposed conduit can be inserted into or removed from the jaws 228A, 228B.

[0070] In some configurations, one or more of the jaws 228A, 228B abut at least a portion of the release mechanism 304. The illustrated release mechanism 304 includes a leaf spring 306. A first portion 308 of the leaf spring 306 is supported by and / or coupled to a pivot pin 310, and the leaf spring 306 is allowed to rotate at least partially about the pivot pin 310. The first portion 308 of the leaf spring 306 includes a cantilever portion 312 that can engage a button 314. The leaf spring 306 includes a second portion 316 that can be configured to rest at least partially against an internal structure of the outer housing 202, the alignment tube 226, etc. The first portion 308 and the second portion 316 can be joined at the proximal end and can extend at an angle to each other. Additionally, the first portion 308 is preferably more rigid than the second portion 310 (e.g., having a greater thickness to resist bending). Rotation of the first portion 308 about the pivot pin 310 causes buckling of the second portion 316 such that the second portion 316 resists rotation of the first portion 308 about the pivot pin 310. More preferably, if the cantilever portion 312 is moved downward by the button 314 in the illustrated configuration, the second portion 316 biases the first portion 308 to the starting position.

[0071] AsFigure 10 and 11 As shown, in certain embodiments, the leaf spring 306 includes a cam portion 318 that engages the jaw 228A. In certain embodiments, the jaws 228A, 228B include a ledge, lip, groove, or cavity 320 that engages the cam portion 318 of the leaf spring 306 when the cam portion 318 slides upward along the side of the jaw 228A a sufficient distance. Thus, the cam portion 318 of the jaw 228A can be locked in a deflected position until a proximally directed force is applied to the alignment tube 226. When the leaf spring 308 is snapped into place on the ledge of the jaw 228A, the leaf spring 308 can make a distinctive clicking sound or other audible noise.

[0072] As discussed above, when the button 314 is pressed into the housing structure 202, the button 314 applies a force to the cantilever portion 312, thereby causing the leaf spring 306 to rotate, pivot, or swing about the pivot pin 310. Movement of the cantilever portion 312 of the leaf spring 306—and thus the first portion 308—causes the cam portion 318 to rotate, which causes the cam portion 318 to effectively slide along a portion of the jaw 228A and snap into place along the jaw 228A. Interaction between the cam portion 318 and the jaw 228A causes the jaw 228A to rotate away from the pivot pin 310. Due to the interface between the mounting recesses 296A, 296B and the posts 284, movement of the jaw 228A causes the alignment tube 226 to move in the proximal direction. Movement of the alignment tube 226 causes both jaws 228A, 228B to rotate, and the clamping on any catheter previously secured within the alignment tube 226 is released such that the catheter can be removed.

[0073] Preferably, the cam portion 318 remains in contact with the surface of the jaw 228A until a subsequent catheter insertion occurs. In the illustrated embodiment, there is provided the slight step 320 against which a portion of the cam portion 318 rests. Movement of the cam portion 318 along the edge of the step 320 produces a sound indicative of the release of the clamping of the catheter for removal. Subsequent insertion of a catheter drives the alignment tube 226 further in the proximal direction, which allows the cam portion 318 of the leaf spring to drop off the step 320 and snap back to its original position, accompanied by a sound indicative of the clamping of the catheter.

[0074] The button 314 can be constructed of plastic, metal, or other suitable materials and can be movably disposed within the housing structure 202. In certain embodiments, the button 314 is coupled to, connected to, or engaged by a spring or other biasing element 322 that applies a force to urge the button 314 toward the outer surface of the top side 204 of the housing structure 202, which is the normal position for the button 314. The button 314 includes a lip or ledge 324 that can be configured to prevent the button 314 from being forced completely out of the housing structure 202 by the spring or other biasing element 322. The spring or other biasing element 322 can be mounted on the stem 323 of the button 314. When the button 314 is pressed into the housing structure 202, the button 314 moves toward a second position where the spring 322 is compressed. In the second position, the button 314 engages and / or applies a force on the cantilever portion 312 of the leaf spring 306, thereby causing the cam portion 318 of the leaf spring 306 to engage the first jaw 228A, resulting in the release of the deployed catheter 102. In certain embodiments, the button 314 engages and / or applies a force on the cantilever portion 312 of the leaf spring 306, thereby causing the cam portion 318 of the leaf spring 306 to engage the first jaw 228A to move or rotate the first jaw 228A toward the proximal end, resulting in the release of the deployed catheter 102. In certain embodiments, the first and second jaws 228A, 228B are coupled (e.g., since the two jaws are connected to the alignment tube 226), and accordingly, when the leaf spring 306 moves or rotates the first jaw 228A toward the proximal end, the first and second jaws 228A, 228B move or rotate toward the proximal end in unison, thereby releasing the clamping of the jaws 228A, 228B on the deployed catheter 102.

[0075] In certain embodiments, the button 314 is also coupled to and / or engaged with a safety slide mechanism 326, as Figure 10 and 11 shown. The safety slide mechanism 326 can be configured to reduce or eliminate the likelihood of the button 314 being pushed into the housing structure 202 unless such movement is desired. The safety slide mechanism 326 can be constructed of plastic, metal, or other similar materials. The safety slide mechanism 326 includes a proximal end 328 and a distal end 330. In certain embodiments, the proximal end 328 includes a cavity or slot 332 that can be configured to engage or receive the lip or ledge 324 of the button 314. In other words, when the slide mechanism is in the proximal position, the edge, ridge, lip, or ledge 324 of the button 314 is disposed within the cavity or slot 332 of the slide mechanism 326, and thus, the slide mechanism 326 reduces the likelihood of the button 314 being accidentally pressed.

[0076] The distal end 330 of the safety slide mechanism 326 is coupled to, or connected, in contact with, or engaged with, a spring or other biasing element 336 that applies a force to urge the safety slide mechanism 326 toward the button 314 such that a lip or ledge 324 of the button 314 engages a cavity or slot 332 of the slide mechanism 326. In some configurations, the safety slide mechanism 326 includes a recess that receives at least a portion of the spring or other biasing element 336. When the safety slide mechanism moves or slides distally toward a second position, the safety slide mechanism 326 releases, disengages, and / or permits the button 314 to be depressed into the housing structure 202.

[0077] Accordingly, in order to remove or unlock or release the distal end of the disposed catheter 102 from the alignment tube, a two-step unlocking process is used in certain embodiments. To unlock the disposed catheter 102, a user first slides the safety slide mechanism 326 toward the distal end, and then the user depresses the button 314 into the housing structure 202 to unlock the disposed catheter 102 and pull the disposed catheter 102 out of the housing structure 202. The two-step unlocking process reduces or eliminates the likelihood of breaking the disposed catheter 102 when the valve 704 is inserted into the disposed catheter 102. Additionally, the two-step unlocking process reduces or eliminates the likelihood of removing the disposed catheter 102 before the valve 704 has been properly positioned within the disposed catheter 102.

[0078] Box

[0079] The cartridge 104 can have any suitable size, shape, and configuration. In the illustrated embodiment, the size, shape of the cartridge 104 is adjusted and the cartridge 104 is configured to be received within the first open cavity 214. More preferably, the size and shape of the cartridge 104 is adjusted and the cartridge 10 is configured to be received within the first open cavity 214 in only one orientation.

[0080] As Figures 12 - 21As shown, the illustrated cartridge 104 generally includes a proximal wall 400 and a distal wall 402, and a first side wall 404 and a second side wall 406 generally extend between the proximal wall 400 and the distal wall 402. The illustrated cartridge 104 also includes a top wall 408 which, for aesthetic reasons, is associated with (e.g., mates with) the outer housing 202 of the valve loader 106 in shape and configuration. The term "wall" should not be construed narrowly as any single surface or member, but rather should be construed broadly, and a wall can be composed of multiple surfaces that are not in a single plane but cooperate with each other to form a general boundary. Thus, the illustrated cartridge 104 includes a generally rectangular box shape with a circular top wall. Other configurations and shapes (e.g., circular, cylindrical square, triangular, conical, trapezoidal, oval, or combinations of these shapes) are also possible.

[0081] The cartridge 104 can be formed in any suitable manner and from any suitable material. In some embodiments, most of the cartridge 104 is molded from plastic or metal or another suitable material.

[0082] The cartridge 104 preferably defines at least one channel 410 extending in the proximal-to-distal direction. In some embodiments, the channel 410 extends from the proximal wall 400 to the distal wall 402. Preferably, the channel 410 includes: a first tapered portion or tapered cavity tube 412 that tapers from proximal to distal, a generally cylindrical portion 414, and a second tapered portion 416 that also tapers from proximal to distal. Thus, the channel 410 extends from a proximal opening 418 to a distal opening 420, and the proximal opening 418 is larger than the distal opening 420. Other configurations are possible, but preferably the diameter of the channel 410 generally decreases from the proximal opening 418 to the distal opening 420.

[0083] The proximal opening 418 is preferably substantially closable using a cap, lid, or cover 422. The cover 422 is Figure 14 shown in Figure 15 and removed in

[0084] The lid 422 preferably defines an opening 428. The opening 428 can have any suitable size and configuration. In the illustrated embodiment, the size and shape of the opening 428 are generally associated with the cross-sectional configuration of the plunger 220. Additionally, teeth or thinner fins 430 extend upwardly into the illustrated opening 428. The teeth 430 are preferably deflectable. The plunger 220 is received within the opening 428 during use, and the teeth 430 snap into place on ribs formed on the plunger. Thus, the teeth 430 serve as an indicator when the plunger 220 is fully depressed, and the teeth 430 also hold the plunger 220 in the fully depressed position until the plunger 220 is acted upon by sufficient force to retract the plunger 220 in the proximal direction.

[0085] At least one channel 410 is preferably configured to receive and store a valve or other medical device 500. The lid 422 is configured to reduce or eliminate the likelihood of the valve or other medical device 500 being removed from the cartridge 104 when it is desired to store the valve or other medical device 500 within the cartridge 104. As shown, the medical device 500 can include a plurality of anchors 502. The anchors 502 can define a diameter. Preferably, the proximal opening 418 located between the lid 422 and the first tapered portion 412 includes a counterbore 432, the outer diameter of the counterbore 432 being greater than the diameter defined by the anchors 502 and the inner diameter being slightly less than the diameter defined by the anchors 502. Thus, the anchors 502 can be captured between the distal wall of the counterbore 432 and the shroud 422.

[0086] In a particular embodiment, the channel 410 can be configured to receive and / or store more than one valve or other medical device 500 having the same or different sizes, shapes, or types. Preferably, different cartridges 104 include different colors, markings, numbers, and / or other unique identifiers to indicate that different sized valves or medical devices 500 are stored within the cartridge 104. In some configurations, the cartridge 104 can use other identification markers (e.g., numbers, colors, letters, patterns, etc.) to indicate different medical devices, including whether different drugs, coatings, etc. are used.

[0087] In a particular embodiment, the cartridge 104 can include a plurality of channels 410 or chambers for storing a plurality of valves or medical devices 500, and the plurality of hollow portions or chambers can be coupled to a daisy wheel or other rotator within the cartridge 104 such that the daisy wheel or other rotator can be rotated or moved (e.g., raised or lowered) by the user, thereby allowing the plurality of valves 500 to be loaded into the delivery catheter 102.

[0088] Cartridge 104 preferably further includes at least one release flap 434. The release flap 434 is connected to the cartridge at the base and may be integrally formed with the cartridge 104. In the illustrated embodiment, each of the two lateral sides has a release flap 434. The end of each release flap 434 includes a finger pad 436 and a locking protrusion 438 just below the finger pad 436. The locking protrusion 438 engages a corresponding structure on the valve loader 106 to lock the cartridge 104 into the first open cavity 214 of the housing structure 202. When the finger pads 436 of the two release flaps 434 are squeezed towards each other, the locking protrusion 438 separates from the structure of the housing 102, and the cartridge 104 is released from the first open cavity 214 of the housing structure 202. In one embodiment, the release flap 434 is integrally formed with the cartridge 104 and is constructed of plastic, polymer, or other suitable material. Other locking configurations may also be used.

[0089] The proximal wall 400 of the cartridge 104 may include at least one groove region or recess 440 that receives an arm, bracket, or rod of the second end 250 of the cartridge locking mechanism 222. Thus, when the second end 250 extends into the first open cavity 214, the second end 250 engages the groove region 440 of the cartridge 104.

[0090] Arrangement conduit

[0091] It should be understood that any type of delivery conduit 102 can be used with the valve loader 106, and the following description of the illustrated delivery conduit 102 is only intended as a general example and not intended to be limiting.

[0092] Reference Figure 22 , the delivery conduit 102 has a proximal end 700 and a distal end 702. The control section 704 is located at the proximal end 700, and the delivery section 706 is located at the distal end 702.

[0093] Reference Figures 22 - 25 , the conduit shaft 710 extends from the proximal end to the distal end. The conduit shaft 710 may be configured to be inserted into a bronchoscope or into the body. Preferably, the conduit shaft 710 includes a lumen tube 712 and a distally located cavity 714. The lumen tube 712 has a distal end that communicates with the cavity 714. In some embodiments, the lumen tube 712 of the conduit shaft 710 may have a coating (e.g., Teflon), or a lining (e.g., a polytetrafluoroethylene (PTFE) lining), or a combination of both. Other configurations are also possible.

[0094] The catheter shaft 710 can be constructed of plastic, metal, polymer, rubber, nylon, other flexible materials, or combinations thereof. In certain embodiments, the catheter shaft 710 is constructed of a flexible polymer extrusion - such as Pebax or nylon. In certain embodiments, the catheter shaft 710 can have different regions including different hardness levels. For example, most of the proximal end of the catheter shaft 710 can have a harder hardness to prevent stretching, while the distal end of the catheter shaft 710 can have a softer hardness to increase flexibility. In some configurations, the catheter shaft 710 can include different fillers or components, such as colorants for coloring, barium sulfate for radiopaque applications, and Teflon for lubrication.

[0095] The distal end of the catheter shaft 710 can include a catheter tip 716. In some embodiments, the catheter tip 716 can be located at the farthest part of the distal end 702. The catheter tip 716 can define at least a portion of a catheter sheath 718 that is retractable relative to the valve 500 such that the valve 500 can be deployed or implanted into the body from the catheter shaft 710.

[0096] In some embodiments, at least a portion of the catheter sheath 718 includes a transparent or translucent material. The catheter sheath 718 and / or the catheter tip 716 can include a valve line (in certain embodiments, the valve line includes a yellow pigment embedded in the catheter sheath 718) to verify proper placement of the valve 500. The valve line indicates where the valve 500 will be positioned in the body.

[0097] The catheter tip 716 preferably includes a metal tip and / or a plastic tip (e.g., Isoplast or other urethane), or other suitable structure that allows the jaws 228A, 228B to clamp and arrange the catheter 102 during loading. In certain embodiments, the plastic tip and / or the metal tip 716 is adhered to, attached to, and / or embedded in the distal end of the catheter 102.

[0098] In certain embodiments, the inner surface of the tip 718 can be coated with a polyurethane anti - caking coating to reduce friction during valve loading and deployment. In some embodiments, the inner surface of the tip 716 or the catheter 102 is uncoated. Instead, the inner surface of the tip 716 or the catheter 102 can include a polytetrafluoroethylene (PTFE) lining on a portion of the end of the catheter 102 being deployed and / or on the inner surface of the tip 718 and / or the tip 716 to reduce friction between the catheter 102 and the valve 500 (including but not limited to any membrane materials on the valve 500). In certain embodiments, the PTFE lining can be a more durable coating (e.g., a wear - reducing coating).

[0099] In certain embodiments, the PTFE liner can be smooth on the inner diameter of the deployment catheter 102—where it contacts the valve 500 here—and chemically etched on the outer diameter of the deployment catheter 102 to provide a rough surface for better adhesion of the outer extrusion. The PTFE liner can be very thin (e.g., wall thickness of about 0.001 inches to 0.002 inches). In certain embodiments, a heat treatment and a sacrificial extrusion (e.g., fluorinated ethylene propylene (FEP) or paraffin wax) can then be used on the outside of the outer catheter extrusion to soft-melt the liner to the outer extrusion of the catheter. The process can be heated to adhere the liner to the extrusion while the sacrificial extrusion (FEP or paraffin wax) is compressed in diameter to provide the force to melt the two materials together.

[0100] In certain embodiments, the deployment catheter 102 can include a deployment guide on the outside of the deployment catheter. The deployment guide can be positioned or embedded at the distal end of the deployment catheter 1020. The deployment guide can comprise a radiopaque material visible to the patient and / or the bronchoscope. The visible nature of the deployment guide allows the user to properly position the valve at the target location.

[0101] Reference Figure 25 , the proximal end of the catheter shaft lumen 714 includes the end 720 of the stabilization wire 722. The stabilization wire end 720 is preferably attached or coupled to the stabilization wire 722 such that the two components move together axially relative to the catheter shaft 710. The end 720 can have any suitable configuration, but preferably includes a recess 724 at the distal end. The recess 724 can be used to enhance control of the valve 500 during deployment.

[0102] The stabilization wire 722 extends through the lumen 712 or passageway in the catheter shaft 710. As discussed above, the lumen 712 in the catheter shaft 710 can be coated to allow the stabilization wire 724 to move more easily within the catheter shaft 710. The stabilization wire 722 will move axially relative to the catheter shaft 710. Thus, the stabilization wire 722 can slide within the catheter shaft 710, move through the catheter shaft 710, or advance within the stabilization wire 722. The stabilization wire 722 can be a stainless steel coil coated with Teflon over a stainless steel wire to allow the catheter shaft 710 to easily pass through the bronchoscope or body passageway.

[0103] In some embodiments, an enhanced shaft portion may be present at the proximal end of the catheter shaft 710, the enhanced shaft portion including a PTFE lining on the interior of the catheter shaft 710. The lining at the proximal end of the catheter shaft 710 is preferably generally thicker than the lining at the distal end of the catheter shaft 710. The thicker lining improves pushability, but reduces the bendability of the enhanced portion, and thus the thinner lining at the distal end enables the catheter shaft 710 to be rotated at a steeper radius than at the proximal end.

[0104] In certain embodiments, the proximal end of the catheter shaft 710 includes a braid located between the PTFE lining and the polymeric extrudate (including, for example, Pebax or nylon). In some embodiments, the braid provides resistance to stretching, buckling, and / or kinking during delivery of the valve or medical device 500 to a desired location. The braid is preferably closer to the inner diameter to reduce stiffness, thereby increasing the flexibility of the catheter shaft 710. The braid may include a polymer (such as nylon, which may be transparent and used for MRI applications), flat wire (such as 0.001 inches by 0.005 inches), or other similar materials. In certain embodiments, the braid includes a 60 pixels per inch configuration, where a pixel refers to the number of open spaces per inch.

[0105] Reference Figure 26 and Figure 27 , the stabilization wire 722 - connected at its distal end to the stabilization wire tip 724 - extends proximally to the cap 726 of the control section 704. For better illustration thereof, the stabilization wire 722 has been labeled at the proximal end of the control section 704 (i.e., at the cap 726) and at the distal end of the control section 704. The proximal end of the stabilization wire 722 may be connected to the cap 726 in any suitable manner. In some instances, the stabilization wire 722 and the cap 726 are press fit, glued, adhered, bonded, comolded, etc.

[0106] The stabilization wire 722 extends proximally through a telescoping hypotube 728. The hypotube 728 encloses a portion of the stabilization wire 722. Thus, the hypotube 728 may provide lateral support to the stabilization wire 722 and may help reduce the likelihood of the stabilization wire 722 buckling, bending, or deforming excessively within the region of the hypotube 728. The hypotube 728 is preferably connected to the cap 726 at the proximal end and abuts the proximal end of the sheath holder 730 at its distal end.

[0107] The distal end of the hypotube 728 is nested within the cannula holder 730. Preferably, the hypotube 728 is axially movable within the cannula holder 730. Thus, in this manner, the hypotube 728 is telescoped relative to the cannula holder 730. The cannula holder 730 extends toward the distal end of the hypotube 728 and extends beyond the proximal end of the catheter shaft 710. Preferably, the proximal end of the catheter shaft 710 extends into the central portion of the cannula holder 730. More preferably, the catheter shaft 710 and the cannula holder 730 are coupled together for axial movement. Any suitable connection may be used.

[0108] The proximal end of a sleeve slider housing 732 snaps into the cap 726, while the distal portion of the sleeve slider housing 732 encases the sleeve holder 730. Other connections may also be used to join the sleeve slider housing 732 and the cap 726. However, the snap fit simplifies construction and manufacturing.

[0109] The distal end of the cannula slider housing 732 tapers toward the proximal portion of the catheter shaft 710. The cannula slider housing 732 allows relative axial movement between the cannula holder 730 and the cannula slider housing 732. In other words, the cannula slider housing 732 is designed to allow the cannula holder 730 to slide proximally relative to the cannula slider housing 732 during deployment of the valve 500. The proximal relative movement causes relative movement between the catheter shaft 710, which is connected to the cannula holder 730, and the stabilizing wire 722, which is connected to the cannula slider housing 732 by being commonly connected to the cap 726.

[0110] Preferably, the sleeve slider housing 732 includes an enlarged slot or window 734. Figure 28 As shown, the slot or window 734 accommodates two fingers 736 of the cannula holder 730. The fingers 736 engage with slots 738 formed in the cannula slider 740. Thus, the cannula slider 740 is coupled to the cannula holder 730 for axial movement and is coupled to the catheter shaft 710 through the cannula holder 730. Thus, any proximally oriented axial movement of the cannula slider 740 will result in proximally oriented axial movement of the catheter shaft 710 relative to the cannula slider housing 732 and the attached stabilization wire 722. In other words, movement of the outer cannula slider 740 relative to the cap 726 and the cannula slider housing 732 will result in movement of the catheter shaft 710 relative to the stabilization wire 722.

[0111] A strain relief tube 742 may wrap at least a proximal portion of the catheter shaft 710. The strain relief tube 742 may extend distally from the control section 704 to a location slightly proximal to the distal end of the catheter shaft 710. In some configurations, the strain relief tube 742 extends between the catheter shaft 710 and a channel within the cannula slider housing 732, and the catheter shaft 710 moves relative to the strain relief tube 742. Thus, in some configurations, the catheter shaft 710 is capable of axial movement relative to the strain relief tube 742. Any suitable material may form the strain relief tube 742. The control section 704 may be constructed of plastic, metal, or other suitable material. Preferably, the cannula slider 740 is a plastic molded part. Accordingly, the formation of the ribs 744 that define the finger hold can be relatively low cost and relatively simple. Other configurations are also possible.

[0112] As described above, by retracting the catheter shaft 710 relative to the stabilizing wire 720, movement of the cannula slider 740 toward the cap 726 can cause deployment movement that ejects the valve 500 from the catheter tip 716 of the catheter shaft 710. Thus, in some embodiments, it is desirable to have a locking feature 746 that reduces or eliminates the inadvertent deployment of the valve 500 from the catheter tip 716.

[0113] The illustrated locking feature 746 includes at least one member that extends between the cap 726 and the cannula slider 740. By extending between at least these two components, the locking feature 746 can reduce the likelihood of inadvertent relative movement between the catheter shaft 710 and the stabilizing wire 720. Of course, it is possible to configure other locking features between the catheter shaft 710 and the stabilizing wire 720 in other ways, by directly or indirectly connecting to the catheter shaft 710 and the stabilizing wire.

[0114] Referring Figure 26 , the locking feature 746 includes a yoke shaped lock lever 748. The lever 748 includes two legs 750 that are joined together at a partial collar 752. Each leg 750 has a peg 754 that snaps into an opening in the cannula slider 740. The peg 754 is pivotable relative to the cannula slider 740 such that the legs 750 and thus the lever 748 as a whole are pivotable relative to the cannula slider 740.

[0115] As discussed above, the lever 748 includes a partial collar 752. The partial collar may extend approximately half way around the lower portion of the cap 726. The degree to which the cap 726 is surrounded can vary depending on the application, but the partial collar 752 preferably extends around the cap 726 by slightly more than 180 degrees. Other configurations are possible.

[0116] The leg 750 bends in a direction opposite to that of the local ring 752. The bending of the leg 750 enables the user to easily manipulate it with one hand. In other words, the bent leg 750 creates a pair of manipulation positions 754, which are further strengthened by the large gasket, thereby facilitating the easy disengagement of the ring 752 from the cap 726. Once the ring 752 is disengaged from the cap 726, the handle 748 can be removed, and the sleeve slider 740 can be pulled upward towards the cap 726 so that the valve 500 can be arranged.

[0117] Refer again to Figure 1 , the transport lock 114 is a generally cylindrical tube in a particular embodiment and may include an inner cavity tube. The transport lock 114 may generally include a shape and size similar to that of the conduit shaft 710 of the arrangement conduit 102. When the valve loader 106 is transported or stored for later use, the transport lock 114 can be configured to be placed in the second open cavity 218 of the housing structure 202. In one embodiment, the transport lock 114 can be inserted into the second open cavity 214 of the housing structure 202 and into the alignment tube 226, where the alignment tube 226 clamps and / or locks the transport lock 114 within the alignment tube 226 in a manner similar to how the arrangement conduit 102 can be locked in the alignment tube 226.

[0118] In a particular embodiment, the loader plunger 220 can be placed or pushed into the housing structure 202 and through the first open cavity 214 of the housing structure 202 into the inner cavity tube of the transport lock 114. Since the distal end of the loader plunger 220 is telescoped, nested, and / or placed in the inner cavity tube of the transport lock 126, the loader plunger 220 can be generally kept stable during transportation and storage, and the flutter or lateral movement of the loader plunger 220 within the alignment tube 226 during transportation and / or storage can be generally prevented. Since the loader plunger 220 is basically placed within the housing structure 202, the breakage of the loader plunger 220 during the transportation and storage of the valve loader 106 is prevented. By inserting the transport lock 114 into the alignment tube 226, the jaws 228A, 228B are in a tension, stress, and / or strain state, which basically prevents the leaf spring 306 from disengaging or uncoupling from the first jaw 228A. When the transport lock 114 is removed, the jaws 228A, 228B advantageously return to their default positions and can be configured to receive the arrangement conduit 102.

[0119] In certain embodiments, the valve loading system 100 is a kit for storage, transportation, and / or loading, and includes a deployment conduit 102, at least one cartridge 104 including a valve 500, and a valve loader 106. In certain embodiments, the cartridge 104 is a separately packaged sterile cartridge 104 for single use and / or disposable use.

[0120] In certain embodiments, the kit and / or components are sterilized by ethylene oxide for single patient use or disposable use. In certain embodiments, the cartridge, valve loader, kit, and / or other components are sterilized or processed for multiple uses.

[0121] Usage method

[0122] The method of using the valve loading system 100 may be described in conjunction with the drawings. However, it should be understood that the various surgical procedures (e.g., pulmonary valve implantation procedure, stent implantation procedure, etc.) that may use the valve loading system 100 may vary depending on the specific purpose and / or technique of the procedure. Accordingly, the following description is only intended to generally illustrate and not limit the method.

[0123] As mentioned above, the user obtains the valve loading system 100. In some configurations, the valve loading system 100 may be obtained from a sterile single patient using a kit that includes a deployment conduit 102, at least one cartridge 104 including a valve 500, and a valve loader 106. The user may slide or move the safety slide mechanism 326 towards the distal end of the housing structure 202 to unlock the button 314 or allow the button 314 to be pressed into the housing structure 202. By pressing the button 314 into the housing structure 202, the transport lock 114 may be unlocked and the user may remove the transport lock 114 from the second access cavity 218. After removing the transport lock 114, the user may release the button 114 and the safety slide mechanism 326. In some configurations, simply pressing the button 314 causes the transport lock 114 to be released, so the button 314 may be released before the transport lock 114 is removed. Then the distal end of the deployment conduit 102 may be inserted into the second access cavity 218. The user may insert the deployment conduit 102 into the second access cavity 218 until the user hears a click or other audible sound that indicates to the user that the deployment conduit 102 has been locked in the housing structure 202 and has been properly positioned within the alignment tube 226.

[0124] In certain embodiments, the user may retract, slide back, or move the loader plunger 220 within the housing structure 202, thereby moving the arm, bracket, or rod of the second end 250 of the cartridge locking mechanism 222 out of the first open cavity 214. The user may select a desired cartridge 104 that includes a valve or medical device 500 of an appropriate size, shape, and / or type. In certain embodiments, the user may appropriately align the cartridge 104 with the first open cavity 214 to insert the cartridge 104 into the first open cavity 214. After the cartridge 104 is fully inserted into the first open cavity 214, the user may push, slide, or move the loader plunger 220 into the housing structure 202, thereby allowing the bayonet end of the loader plunger 220 to contact the valve or medical device 500 within the cartridge 104.

[0125] As the plunger 220 contacts the loader pin ( Figures 29 to 31 described in more detail herein) and pushes the valve or medical device 500 via the central portion towards the distal end of the cartridge 104 and through the tapered or funnel portion of the cartridge 104, the valve or medical device 500 becomes compressed. With the valve or medical device 500 compressed, the user may continue to push the loader plunger 220 into the housing structure 202, thereby pushing the compressed valve or medical device 500 through the alignment insert 224 and alignment tube 226 and into the distal end of the deployment catheter 102. With the deployment catheter 102 loaded with the valve or medical device 500, the user may slide or move the safety slide mechanism 326 towards the distal end of the housing structure 202 to unlock the button 314 or allow the button 314 to be depressed into the housing structure 202.

[0126] When the button 314 is depressed into the housing structure 202, the deployment catheter 102 is unlocked such that the user may remove the deployment catheter 102 from the second open cavity 218. In certain embodiments, the user may place the loaded deployment catheter 102 at a desired location within the patient's body to implant the valve or medical device 500 within the patient. In certain embodiments, the deployment catheter 102 advances through the channel of a bronchoscope and is navigated to the target implantation location. In certain embodiments, the valve or medical device 500 (e.g., including radiopaque material) may be visible through the deployment catheter 102, allowing the user to properly position the valve at the target location. In certain embodiments, the user may use a guide (which may include radiopaque material visible through the body) to allow the user to properly position the valve at the target location.

[0127] In certain embodiments, to deploy the valve or medical device 500, the user unlatch, rotate, or swing the locking feature 746 to disengage the locking feature 746 from the housing 726. The user can actuate the control portion 704 to cause the catheter sheath 710 to retract relative to the stabilizing wire 722, thereby releasing the valve or medical device 500. Through the stabilizing wire 722, the position of the valve or medical device 500 is stabilized at the target position during deployment.

[0128] In certain embodiments, after the valve or medical device 500 has been deployed, the deployment catheter 102 can be retrieved from the patient's body and another valve or medical device 500 can be reloaded using the foregoing process. Using the foregoing process, the deployment catheter 102 can be reloaded with a different valve or medical device 500 having different shapes, sizes, and / or types. The foregoing process also allows the valve or medical device 500 to remain in a default configuration, as opposed to a substantially compressed or compacted configuration, thereby reducing the likelihood of failure, wear, and / or deterioration of the valve or medical device 500. In other words, the cartridge 104 stores the valve or medical device 500 in a non-compressed state, which reduces wear and tear on the medical device 500 and decreases the likelihood of adverse clinical events associated with the materials or construction of the medical device 500.

[0129] In one embodiment, as Figures 29 to 31 shown, the proximal end of the loader pin 800 is attached to the distal end of the plunger 220. The plunger is secondarily formed on the proximal end of the loader pin 800. The proximal end of the loader pin 800 can include a flange. The loader pin 800 has a proximal portion with a first cross-sectional dimension and a distal portion with a second cross-sectional dimension. In a previous configuration of the loader pin, the proximal and distal ends of the loader pin had equal cross-sectional dimensions. When the anchor 502 is compressed and when the valve is fully loaded into the deployment catheter, the strut contacts the distal end of the loader pin. When the loader pin is retracted after loading the valve, the contact with the anchor 502 causes some friction, with the possibility of altering the position of the loaded valve. Accordingly, a low-friction coating is applied to the distal end of the loader pin to reduce this friction. In one embodiment, the first cross-sectional dimension is greater than the second cross-sectional dimension. The reduced cross-sectional dimension at the distal portion reduces or eliminates contact with the anchor 502 when the valve is loaded into the deployment catheter. Accordingly, when the loader pin 800 is retracted after the step of loading the valve into the catheter, the friction is eliminated or greatly reduced.

[0130] In one embodiment, the loader pin 800 is made of stainless steel and hardened to spring temper. The spring temper allows the pin 800 to withstand the loading force without warping.

[0131] In one embodiment, the distal surface of the loader pin 800 is cup-shaped (i.e., concave). The cup shape can provide additional alignment with the center of the valve during loading.

[0132] In one embodiment, the surface of the loader pin 800 is manufactured to have a smoother surface than the anchor 502.

[0133] In one embodiment, the surface of the loader pin 800 is manufactured to have a rougher surface than the anchor strut. Since the anchor 502 has a smooth, plated surface, the slightly rougher loader pin 800 can reduce the coefficient of friction between the anchor 502 and the loader pin 800.

[0134] In one embodiment, the loader pin includes an inner pin and an outer tube. They are inserted together, but then the pin is removed, allowing the tube to partially collapse and reduce in diameter. This facilitates easier removal. The collapsing force is a compressive force from the anchor strut. The force that deforms the tube will depend on the wall thickness of the tube. For example, the wall thickness will be <.003”.

[0135] In one embodiment, the loader pin 800 includes a tapered portion between the proximal portion and the distal portion. Other transitions may occur between the proximal portion and the distal portion.

[0136] Although the invention has been disclosed in the context of specific embodiments and examples, those skilled in the art will understand that the scope of the invention can extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as obvious modifications and equivalents. Additionally, although several variations of the invention have been shown and described in detail, other modifications that fall within the scope of the invention will be apparent to those skilled in the art based on this disclosure. Combinations and sub-combinations of the specific features and aspects of the embodiments are also contemplated and still fall within the scope of the invention. It should be understood that the different features and aspects of the disclosed embodiments can be combined or substituted for one another to form different modes or embodiments of the disclosed invention. Therefore, it is intended that the scope of the invention disclosed herein not be limited by the specific disclosed embodiments described above.

Claims

1. A valve loader, comprising: a housing including a cavity configured to receive at least one replaceable medical device cartridge configured to contain a deployable medical device therein, the housing further comprising: an actuator configured to direct the deployable medical device from the at least one replaceable medical device cartridge to a discharge end of the housing, the discharge end configured to receive a deployment device into which the deployable medical device can be loaded, the actuator including: a loader pin, the actuator being overmolded on a proximal end of the loader pin, struts of an anchor of the deployable medical device contacting a distal end of the loader pin, the loader pin including a proximal portion having a first cross-sectional dimension and a distal portion having a second cross-sectional dimension less than the first cross-sectional dimension to reduce frictional contact with the deployable medical device.

2. The valve loader according to claim 1, wherein the loader pin is configured to reduce contact with the deployable medical device when the actuator is in a fully actuated state.

3. The valve loader according to claim 1, wherein a distal surface of the loader pin is cup-shaped, i.e., concave.

4. A valve loading system, comprising: a valve loader including: an outer housing structure having a proximal end and a distal end, the distal end including a cavity; a first open cavity positioned between the proximal end and the distal end; and a loading device slidably received within a cavity tube at the proximal end, the loading device including: an actuator extending outside of the outer housing structure; and a loader pin located at the distal end of the outer housing structure, the loader pin including: a proximal portion having a first cross-sectional dimension, the actuator being overmolded on the proximal end of the loader pin; and a distal portion having a second cross-sectional dimension less than the first cross-sectional dimension; a deployment device configured to be received within the cavity at the distal end of the outer housing structure; and a cartridge configured to contain a deployable medical device and configured to be received within the first open cavity, struts of an anchor of the deployable medical device contacting a distal end of the loader pin, and wherein distal movement of the loading device causes the loader pin to direct the deployable medical device into the deployment device when the deployable medical device is received within the cavity at the distal end of the outer housing structure.

5. The valve loading system according to claim 4, wherein the cavity at the distal end of the outer housing structure includes a funnel-shaped channel positioned away from the first open cavity, the funnel-shaped channel configured to permit the deployable medical device to pass therethrough when the loader pin directs the deployable medical device from the cartridge into the deployment device.

6. The valve loading system according to claim 4, wherein the outer housing structure further includes a clip configured to secure the placement device to the outer housing structure when the deployable medical device is loaded into the placement device.

7. The valve loading system according to claim 4, wherein the outer housing structure further includes a locking device to prevent the placement device from being inadvertently released before the deployable medical device is properly loaded into the placement device.

8. The valve loading system according to claim 4, wherein the cartridge includes a stop device to signal that the loading device has traveled to the correct position for fully loading the deployable medical device into the placement device.

9. The valve loading system according to claim 4, wherein the cartridge includes a device for providing an audible sound to signal to the user that the loading device has traveled to the correct position for fully loading the deployable medical device into the placement device.

10. The valve loading system according to claim 6, wherein the outer housing structure further includes a device for providing an audible sound to signal to the user that the placement device has been locked into the clip and loading can begin.

11. The valve loading system according to claim 4, wherein the outer housing structure further includes a safety device to prevent damage to the loading device due to improper installation or removal of the cartridge within the first open cavity.

12. The valve loading system according to claim 4, wherein the distal surface of the loader pin is cup-shaped, i.e., concave.

Images