Integrated loading and storage system for implantable medical devices

Abstract

The loading device includes a locking ring assembly having a proximal end, a distal end, and a loading channel formed therebetween. The device also includes a loading funnel coupled to the distal end of the locking ring assembly at the proximal end of the loading funnel. The loading funnel is configured to store a collapsible medical device in a partially collapsed state within a conical interior volume of the loading funnel. The conical interior volume decreases in volume from the distal end of the loading funnel to the proximal end of the loading funnel.

Description

Technical Field

[0001] The present technology generally relates to loading and storage systems for medical devices. Background Art

[0002] Currently, implantable medical devices, such as stents, frameworks, and other cardiac interventional devices containing organic tissue (e.g., bovine and porcine), require on-site installation onto a delivery device. This is because the implantable devices must be stored under specific conditions to preserve the organic tissue. Typically, a detailed procedure must be performed to install the medical device onto the delivery device. However, this detailed procedure can be cumbersome and costly due to the potential for damage to the implantable medical device during installation. Summary of the Invention

[0003] The technology of the present disclosure generally relates to a combination storage and loading system for loading an implantable medical device onto a delivery device and converting the implantable medical device from an uncompressed state to a compressed state.

[0004] In one aspect, the present disclosure provides a device for storing and loading medical devices onto a delivery device. The device includes a locking ring assembly having a proximal end, a distal end, and a loading channel formed therebetween. The device also includes a loading funnel coupled to the distal end of the locking ring assembly at the proximal end of the loading funnel. The loading funnel is configured to store a collapsible medical device in a partially collapsed state within a conical interior volume of the loading funnel. The conical interior volume decreases from the distal end of the loading funnel to the proximal end of the loading funnel. The device includes a retainer positioned at the distal end of the locking ring assembly along with the loading channel and includes a connector configured to connect to the delivery device. The collapsible medical device can be coupled to the retainer. Prior to connection to the delivery device, the retainer holds the collapsible medical device within the loading funnel. The device also includes a nose cone pin coupled to the retainer and positioned within the conical interior volume of the loading funnel. The device also includes a storage tank coupled to the distal end of the loading funnel. The storage canister is configured to retain the collapsible medical device and the nose cone pin within the conical interior volume of the loading funnel.

[0005] In another aspect, the present disclosure provides a device for storing and loading medical devices onto a delivery device. The device includes a locking ring assembly having a proximal end, a distal end, and a loading channel formed therebetween. The device also includes a loading funnel coupled to the distal end of the locking ring assembly at the proximal end of the loading funnel. The loading funnel is configured to store a partially collapsed collapsible medical device within a conical interior volume of the loading funnel. The conical interior volume decreases from the distal end of the loading funnel to the proximal end of the loading funnel. The device also includes a retainer positioned at the distal end of the locking ring assembly along with the loading channel and including a connector configured to connect to the delivery device. The collapsible medical device can be coupled to the retainer. Prior to connection to the delivery device, the retainer holds the collapsible medical device within the loading funnel. The device includes a nose cone pin coupled to the retainer and positioned within the conical interior volume of the loading funnel. The device also includes a funnel cap coupled to the distal end of the loading funnel. The funnel cap is configured to retain the collapsible medical device and the nose cone pin within the conical interior volume of the loading funnel.

[0006] In another aspect, the present disclosure provides a method for storing and loading a medical device onto a delivery device. The method includes washing a collapsible medical device stored in a partially collapsed state within a conical interior volume of a loading device with a sterile solution. The method also includes coupling the delivery device to a retainer positioned within the loading device. Prior to coupling to the delivery device, the retainer retains the collapsible medical device within the loading device in the partially collapsed state. Furthermore, the method includes retracting the retainer through a loading channel of the loading device, wherein retracting the retainer causes the collapsible medical device to move through the conical interior volume to compress the collapsible medical device. The method includes removing the loading device from the delivery device. The method also includes sealing the collapsible medical device within the delivery device.

[0007] The details of one or more aspects of the present disclosure are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of the technology described in this disclosure will become apparent from the detailed description and drawings, as well as the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The foregoing and other features and advantages of the present disclosure will become apparent from the following description of the embodiments illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, further serve to explain the principles of the present disclosure and to enable one skilled in the relevant art to make and use the embodiments of the present disclosure. The drawings are not drawn to scale.

[0009] Figure 1A Depicted is a perspective view of a loading system for use with a medical device, according to an embodiment thereof.

[0010] Figure 1B Described according to the embodiment Figure 1A Cross-section of the loading system.

[0011] Figures 2A-2C Described according to the embodiment Figure 1A and 1B Several illustrations of the locking ring assembly of the loading system.

[0012] Figure 3A and 3B Described according to the embodiment Figure 1A and 1B Illustration of the loading funnel of the loading system.

[0013] Figure 4A and 4B Described according to the embodiment Figure 1A and 1B Illustration of the funnel cap of the loading system.

[0014] Figure 5A and 5B Described according to the embodiment Figure 1A and 1B Illustration of the device holder of the loading system.

[0015] Figure 6 Described according to the embodiment Figure 1A and 1B Illustration of the nose cone pin of the loading system.

[0016] Figure 7 Described according to the embodiment Figure 1A and 1B Illustration of the storage of the loading system.

[0017] Figure 8 Depicts a method for operating according to an embodiment thereof Figure 1A and 1B Flowchart of the process of loading the system.

[0018] Figures 9A-9I Described according to the embodiment Figure 1A and 1B Several illustrations of the operation of the loading system.

[0019] Figure 10A Depicted is a perspective view of another loading system for use with a medical device, according to embodiments thereof.

[0020] Figure 10B Described according to the embodiment Figure 10A Cross-section of the loading system.

[0021] Figure 11A and11B Described according to the embodiment Figure 10A and 10B Illustration of the locking ring of the loading system.

[0022] Figure 12A and 12B Described according to the embodiment Figure 10A and 10B Illustration of the cap of the loading system.

[0023] Figure 13A and 13B Described according to the embodiment Figure 10A and 10B Illustration of the loading funnel of the loading system.

[0024] Figures 14A-14C Described according to the embodiment Figure 10A and 10B Several illustrations of the storage tanks of the loading system.

[0025] Figure 15A and 15B Described according to the embodiment Figure 10A and 10B Illustration of the fluid ports of the loading system.

[0026] Figure 16 Depicts a method for operating according to an embodiment thereof Figure 10A and 10B Flowchart of the process of loading the system.

[0027] Figures 17A-17I Described according to the embodiment Figure 10A and 10B Several illustrations of the operation of the loading system. DETAILED DESCRIPTION

[0028] Specific embodiments of the present disclosure are now described with reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements.

[0029] The following detailed description describes examples of embodiments and is not intended to limit the technology or its applications and uses. Although the embodiments herein are described in the context of a storage and loading device for a prosthetic heart valve, the technology may also be used in other devices. Furthermore, no intention is to be bound by any expressed or implied theory presented in the preceding technical field, background, summary, or the following detailed description.

[0030] Embodiments disclosed herein relate to a loading system for storing an implantable medical device and loading the implantable medical device onto a delivery device. In an embodiment, the loading system stores a medical device, such as an artificial heart valve, in a partially compressed or "loaded" state. The loading system stores the medical device in a preservation fluid so that the medical device can be stored for a period of time without degrading the medical device. When the medical device is ready for implantation, the loading system is attached to the delivery device. The loading system enables the medical device to be loaded into the delivery device without directly interacting with the medical device. Thus, the loading system can provide storage and loading of implantable medical devices at a reduced cost and in a portable manner. The integrated design of the loading system reduces the steps of cleaning, sterilizing, and loading the implantable medical device.

[0031] Figure 1A and 1B An example of a loading system 100 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 1A and 1B An example of a loading system is shown and Figure 1A and 1B Existing components shown in FIG. 1 may be removed and / or additional components may be added to loading system 100 .

[0032] like Figure 1A As shown, the loading system 100 includes a locking ring assembly 102, which includes a split ring 104 and a locking ring 106. The loading system 100 also includes a loading funnel 108 and a funnel cap 110. Figure 1B As shown, the locking ring assembly 102 further includes a device holder 112 and a nose cone pin 114. When coupled to the loading system 100, the device holder 112 is positioned within the locking ring 106 of the locking ring assembly 102. The nose cone pin 114 is coupled to the device holder 112 and extends through the loading funnel 108.

[0033] The device holder 112 is coupled to an implantable medical device 116. In an embodiment, any type of implantable medical device that needs to be converted from an uncompressed state to a compressed state and that needs to be loaded onto a delivery device can be used with the loading system 100. In one embodiment, the implanted medical device 116 can include a component intended to repair or support a human body system, for example, an artificial heart valve comprising organic tissue, which is coupled to a self-expanding or balloon-expandable stent / frame. For example, the loading system 100 can be used on implantable medical devices that are to be delivered transluminally, for example, via a catheter, and need to be loaded onto or into a catheter. The stent / frame can be radially compressed to have a low profile and loaded into / onto the delivery device so that the heart valve prosthesis can be delivered to a target location through a blood vessel in a compressed state and then expanded at the target location, for example, via a self-expanding stent / frame or balloon of the delivery device, for example to replace a natural heart valve.

[0034] The loading system 100 is configured to store the implantable medical device 116 in a partially compressed or "loaded" state. That is, the loading funnel 108 is configured to apply a force to the implantable medical device 116 to partially compress the implantable medical device 116 and maintain the implantable medical device 116 in the partially compressed state during storage. In an embodiment, as further described below, the loading funnel 108 is formed with a tapered lumen that maintains the implantable medical device 116 in the partially compressed state and operates to further compress the implantable medical device 116 when the implantable medical device 116 is loaded onto a delivery device.

[0035] The locking ring assembly 102 enables a delivery device, such as a catheter, to be attached to the device holder 112 with minimal interaction with the implantable medical device 116. In one embodiment, as further described below, the delivery device (or a component of the delivery device) is inserted into the locking ring assembly 102 and attached to the device holder 112. To load the implantable medical device 116, the device holder 112 is retracted into the delivery device. As the device holder 112 is retracted, the implantable medical device 116 is further compressed by the loading funnel 108.

[0036] Figures 2A-2C An example of a locking ring assembly 102 according to an embodiment thereof is shown. Those skilled in the art will recognize that Figures 2A-2C An example of a locking ring assembly is shown and Figures 2A-2C Existing components shown may be removed and / or additional components may be added to locking ring assembly 102 .

[0037] like Figure 2A As shown, the split ring 104 includes a first half-ring 202 and a second half-ring 204. When joined, the first half-ring 202 and the second half-ring 204 form a proximal opening 206, a distal opening 208, and a loading channel 212. The loading channel 212 is formed into a substantially cylindrical shape with a circular cross-section and has an inner diameter d1. The loading channel 212 is formed with a diameter d1 to accommodate the device holder 112 and allow a delivery device, such as a catheter, to be inserted into the split ring 104. In an embodiment, the diameter d1 of the device channel 212 can depend on the French (FR) size of the catheter. For example, the diameter d1 of the loading channel 212 can be formed to accommodate a catheter of 18-33 Fr. In an embodiment, the delivery device can be inserted into the proximal opening 206, and the device holder 112 can be positioned at or near the distal opening 208. The split ring 104 can be formed of any suitable material, such as, but not limited to, a polymeric material.

[0038] For example, the loading system 100 can be configured to store and load a 42 millimeter (mm) transcatheter mitral valve replacement (TMVR) device, such as a heart valve and frame. In such an embodiment, the loading channel 212 can be formed to have a diameter d1 in the range of about 6 mm to about 13 mm. In another example, the loading system 100 can be configured to store and load a 48 mm TMVR device. In such an embodiment, the loading channel 212 can be formed to have a diameter d1 in the range of about 6 mm to about 13 mm. Those skilled in the art will recognize that the loading channel 212 can be formed to any size and / or cross-sectional shape to accommodate different medical devices and / or delivery devices.

[0039] The first half-ring 202 and the second half-ring 204 include tabs 214. The tabs 214 can be configured to provide a connection and / or interface point to the loading funnel 108. The tabs 214 allow fluid to enter the interior space of the split ring 104 and allow air to exit the interior space of the split ring 104. This may prevent air from being trapped between the implantable medical device 116 and the delivery device.

[0040] The first half ring 202 and the second half ring 204 include a connector pin 216 and a connector hole 218. When the first half ring 202 and the second half ring 204 are joined to form the split ring 104, the connector pin 216 aligns with the connector hole 218 to engage with the connector hole 218. The split ring 104 includes the first half ring 202 and the second half ring 204 to allow the split ring 104 to be separated and removed once the implantable medical device 116 is loaded into the delivery device.

[0041] like Figure 2B As shown, the split ring 104 further includes a circular ridge 220 positioned adjacent to and / or proximal to the distal opening 208. The circular ridge 220 extends radially inward from the inner surface of the split ring 104. In one embodiment, the circular ridge 220 can be formed in an approximately annular and / or toroidal shape. The circular ridge 220 is formed to have a diameter d2 that is smaller than the diameter d1 of the loading channel 212. In one embodiment, the circular ridge 220 can be formed to have a diameter d2 that is larger than the diameter of the device holder 112 but smaller than the outer diameter of the delivery device, such as the diameter of the outer shaft of the delivery device to be inserted into the locking ring 104. In this embodiment, the circular ridge 220 can prevent the implantable medical device 116 from contacting the delivery device during the loading process, that is, provide protection for the implantable medical device 116 during the loading process.

[0042] The split ring 104 includes male threads 210 formed on an outer surface of the split ring 104 and positioned at or near the distal opening 208. The male threads 210 are configured to engage the female threads 256 ( Figure 2C) and secures the split ring 104 to the locking ring 106. Female threads 256 are formed on the inner surface of the locking ring 106 and are located along the entire length of the inner surface of the locking ring 106. As described herein, "female" threads and / or connectors are generally receptacles that receive and retain "male" threads and / or connectors. Once the locking ring 106 is secured to the split ring 104, the locking ring 106 applies a force to the first and second half rings 202, 204 to hold the first and second half rings 202, 204 together.

[0043] although Figures 2A-2C Threads are shown for coupling the split ring 104 and the locking ring 106, but those skilled in the art will appreciate that other types of connectors may be used to mechanically couple the split ring 104 and the locking ring 106. In some embodiments, the split ring 104 and the locking ring 106 may comprise a push-fit locking ring that acts as an interference fit to couple the split ring 104 and the locking ring 106. For example, the outer diameter of the split ring 104 may be larger than the inner diameter of the locking ring 106. In some embodiments, the split ring 104 and the locking ring 106 may comprise a C-clip mechanism connector that acts as a mechanical interference between the split ring 104 and the locking ring 106. In some embodiments, the split ring 104 and the locking ring 106 may comprise a snap-fit ​​connection (e.g., cantilever, torsion, and / or annular). For example, the split ring 104 may include a protruding edge or tab, and the locking ring 106 may include an engaging area (e.g., a groove, a channel, etc.) for receiving and locking the protruding edge or tab. Likewise, for example, the locking ring 106 may include a protruding edge or tab, and the split ring 104 may include an engaging area (eg, a groove, a channel, etc.) for receiving and locking the protruding edge or tab.

[0044] like Figure 2A and 2C As shown, the locking ring 106 includes a first end 250 and a second end 252. The locking ring 106 includes an external ridge 254. The external ridge 254 may provide a textured surface to help secure the locking ring 106 to the split ring 104. The locking ring 106 may be formed from any suitable material such as, but not limited to, a polymeric material.

[0045] Figure 3A and 3B An example of a loading hopper 108 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 3A and 3B An example of a loading hopper is shown and Figure 3A and 3B Existing components shown in FIG. 1 may be removed and / or additional components may be added to the funnel 108 .

[0046] like Figure 3AAs shown, the loading funnel 108 includes a funnel body 302 having a proximal end 304 and a distal end 306. The funnel body 302 is formed into an approximately conical shape, with the proximal end 304 having a smaller diameter than the distal end 306. The loading funnel 108 includes a male thread 308 formed on an outer surface of the loading funnel at the distal end 306 of the funnel body 302. The male thread 308 is configured to engage with a female thread of the funnel cap 110, as described below. The funnel body 302 can be formed from any suitable material, such as, but not limited to, stainless steel.

[0047] like Figure 3A and 3B As shown, the loading funnel 108 includes a proximal opening 310 having a diameter f1 formed in the proximal end 304 of the funnel body 302. The loading funnel 108 also includes a distal opening 312 having a diameter f2 formed in the distal end 306 of the funnel body 302. The interior of the funnel body 302 forms a compression volume 311. The compression volume 311 is formed in a substantially funnel or conical shape, with a volume decreasing from the distal end 306 to the proximal end 304 of the funnel body. In one embodiment, the compression volume 311 tapers with a decreasing diameter from the diameter f2 at the distal end 306 to the diameter f1 at the proximal end 304. The compression volume 311 may be formed by a first funnel portion 314, a second funnel portion 316, a third funnel portion 318, and a fourth funnel portion 320. Each of first funnel portion 314, second funnel portion 316, third funnel portion 318, and fourth funnel portion 320 can be formed in the shape of a funnel, each having a different degree of volume reduction from distal end 306 to proximal end 304. In an embodiment, the volume of compression volume 311 operates to maintain implantable medical device 116 in a partially compressed state during storage.

[0048] In embodiments, the degree of volume reduction, such as the taper angle, can affect the angle at which the implant attachment tab exits the funnel, with a longer taper improving loading of the implantable medical device 116. A longer taper can provide a smoother transition for the implantable medical device 116 during loading into the delivery device. A shorter taper can impose compressive strain on the implantable medical device 116, may require greater force during loading, may result in uneven crimping, may cause inflow of the implantable medical device 116, or may impose additional compressive loads on the implantable medical device 116 during storage. Depending on the degree of volume reduction, for example, the taper angle can be set to minimize these and ensure the integrity of the implantable medical device 116.

[0049] In an embodiment, when the device holder 112 is retracted through the loading channel 212, the reduced volume of the compression volume 311 operates to exert a compressive force on the implantable medical device 116. That is, when the device holder 112 is retracted into the delivery device positioned in the loading channel 212, the implantable medical device 116 is retracted through the proximal opening 310 in the loading direction L. As the implantable medical device 116 moves through the compression volume 311, the inner surface of the loading funnel 302 exerts a compressive force on the surface of the implantable medical device 116.

[0050] In an embodiment, the diameter f1 of the proximal opening 310 can depend on the FR size of the catheter. For example, the diameter f1 of the proximal opening 310 can be formed to accommodate an 18-33 Fr catheter. In an embodiment, the diameter f2 of the distal opening 312 can depend on the outer diameter of the implantable medical device 116.

[0051] In some embodiments, the loading system 100 can be configured to store and load a 42 mm TMVR device, and in such embodiments, the diameter f1 can be in the range of approximately 6 mm to approximately 13 mm, and the diameter f2 can be in the range of approximately 20 mm to approximately 60 mm. In another example, the loading system 100 can be configured to store and load a 48 mm TMVR device, and the proximal opening 310 can be formed to have a diameter f1, and the distal opening 312 can be formed to have a diameter f2. In such embodiments, the diameter f1 can be in the range of approximately 6 mm to approximately 13 mm, and the diameter f2 can be in the range of approximately 20 mm to approximately 60 mm. Those skilled in the art will recognize that the compression volume 311 can be formed to any size and / or cross-sectional shape to accommodate different medical devices and / or delivery devices.

[0052] Figure 4A and 4B An example of a funnel cap 110 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 4A and 4B An example of a funnel cap is shown and Figure 4A and 4B Existing components shown in FIG. 1 may be removed and / or additional components may be added to the funnel cap 110 .

[0053] like Figure 4A As shown, the funnel cap 110 includes a cap body 402 and a nose cone pin housing 404. The cap body 402 can be formed into an approximately cylindrical shape and include a cap recess 406. For example, Figure 4AAs shown, the cap body 402 may include four (4) cap notches 406 positioned at opposing locations around the cap body 402. The cap notches 406 may provide locations for applying leverage when removing the hopper cap 110 from the loading hopper 108, as described in further detail below. The cap body 402 may be formed from any suitable material, such as, but not limited to, a polymeric material.

[0054] The cap body 402 may further include a female thread 408 formed on an inner surface of the cap body 402. The female thread 408 may be formed to mate with and engage with the male thread 308 on the outer surface of the loading funnel 108 to secure the funnel cap 110 to the loading funnel 108. The nose cone pin housing 404 may be formed into a generally cylindrical shape. The nose cone pin housing 404 is configured to retain the nose cone pin 114. That is, when the nose cone pin 114 is stored within the loading system 100, the nose cone pin 114 abuts the bottom surface of the nose cone pin housing 404. The sidewalls of the nose cone pin housing 404 hold the nose cone pin 114 in place and prevent the nose cone pin 114 from moving laterally within the loading system 100. The nose cone pin housing 404 may be formed from any suitable material, such as, but not limited to, a polymeric material.

[0055] like Figure 4A and 4B As shown, the cap body 402 and the nose cone pin housing 404 include a port 410. The port 410 can be configured to enable fluid to enter and exit the interior of the funnel cap 110. The funnel cap 110 operates to prevent the device holder 112 and the implantable medical device 116 from exiting the distal opening 312 of the loading funnel 108. That is, the nose cone pin housing 404 (e.g., the bottom surface) exerts a force on the nose cone pin 114 connected to the device holder 112 to prevent the device holder 112 and the implantable medical device 116 from sliding distally out of the loading funnel 108 due to the compressive force of the loading funnel 108 when the implantable medical device 116 is in a partially compressed state.

[0056] although Figure 3A 、 3B 4A and 4B illustrate threads for connecting the loading funnel 108 and the funnel cap 110 , but those skilled in the art will appreciate that other types of connectors may be used to mechanically couple the loading funnel 108 and the funnel cap 110 .

[0057] In some embodiments, the loading funnel 108 and the funnel cap 110 may include a push-fit locking ring that acts as an interference fit to couple the loading funnel 108 and the funnel cap 110. For example, the outer diameter of the loading funnel 108 may be larger than the inner diameter of the funnel cap 110.

[0058] In some embodiments, the loading funnel 108 and the funnel cap 110 may include a C-clip mechanism connector that serves as a mechanical interference between the loading funnel 108 and the funnel cap 110. In some embodiments, the loading funnel 108 and the funnel cap 110 may include a snap-fit ​​connection (e.g., cantilever, twist, and / or annular). For example, the loading funnel 108 may include a protruding edge or tab, and the funnel cap 110 may include a snap-fit ​​connection (e.g., a groove, a channel, etc.) for receiving and locking the protruding edge or tab. Similarly, for example, the funnel cap 110 may include a protruding edge or tab, and the loading funnel 108 may include a snap-fit ​​connection (e.g., a groove, a channel, etc.) for receiving and locking the protruding edge or tab.

[0059] Figure 5A and 5B An example of a device holder 112 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 5A and 5B An example of a device holder is shown and Figure 5A and 5B Existing components shown in FIG. 1 may be removed and / or additional components may be added to the device holder 112 .

[0060] like Figure 5A As shown, the device holder 112 includes a first portion 502 formed at the proximal end of the device holder 112 and a third portion 506 formed at the distal end 509 of the device holder 112. The device holder 112 also includes a second portion 504 formed between the first portion 502 and the third portion 506. The first portion 502 is configured to be coupled to a delivery device, as described in further detail below. The third portion 506 is configured to be coupled to the implantable medical device 116. The first portion 502, the second portion 504, and the third portion 506 are formed into a cylindrical shape. The second portion 504 can be formed to have an outer diameter smaller than the first, second, and third portions 502, 506. In one embodiment, the second portion 504 can be used as a channel for receiving a sealing ring (e.g., an O-ring). The sealing ring can operate to form a hydraulic circuit in the delivery device as part of a pressurization system that seals a component (e.g., a capsule) of the delivery device.

[0061] Device holder 112 includes a fourth portion 508 formed at a distal end 509 of device holder 112. Fourth portion 508 includes a locking channel 510, a distal opening 512, female threads 514, and a port 516. Locking channel 510 is configured to engage with implantable medical device 116. In one example, locking channel 510 can be a T-shaped slot configured to receive a T-shaped tab on the frame / support of implantable medical device 116. That is, the T-shaped tab on implantable medical device 116 can be configured to lock into the T-shaped slot of locking channel 510 to secure implantable medical device 116 to device holder 112. Port 516 allows an operator of the delivery device to degas the area surrounding implantable medical device 116 before and / or after loading implantable medical device 116. For example, liquid can be injected into the port at the proximal end of the delivery device and exit through port 516.

[0062] Female threads 514 are formed on the inner surfaces of the third portion 506 and the fourth portion 508. The female threads 520 are configured to mate with the male threads of the nose cone pin 114 (e.g., Figure 6 The nose cone pin 114 is engaged with the male thread 616 shown to secure the nose cone pin 114 to the device holder 112. The device holder 112 may be formed from any suitable material such as, but not limited to, a polymeric material.

[0063] like Figure 5B As shown, the device holder 112 includes a proximal opening 518. The device holder 112 includes female threads 520 on an inner surface of the first portion 502. The female threads 520 are configured to engage with male threads of a delivery device to secure the device holder 112 to the delivery device.

[0064] Figure 6 An example of a nose cone pin 114 according to an embodiment thereof is shown. Those skilled in the art will recognize that Figure 6 An example of a nose cone pin is shown and Figure 6 Existing components shown in FIG. 1 may be removed and / or additional components may be added to the nose cone pin 114 .

[0065] like Figure 6 As shown, the nose cone pin 114 includes a first portion 602 formed at the distal end of the nose cone pin 114. The first portion 602 includes a male thread 604 formed adjacent to and / or near the distal end of the nose cone pin 114. The male thread 604 is configured to engage with a female thread of one or more devices that may be associated with the delivery device. For example, the male thread 604 can be configured to engage with a female thread of a nose cone or cap that seals the delivery device once the implantable medical device 116 is loaded. The nose cone pin 114 can be formed from any suitable material, such as, but not limited to, a polymeric material.

[0066] The nose cone pin 114 includes a second portion 606 formed adjacent to the first portion 602. The second portion 606 is formed into a cylindrical shape and includes a distal tapered edge 608 and a proximal tapered edge 610. The second portion 606 is formed into a diameter that matches a delivery device, such as an outer shaft. The nose cone pin 114 includes a third portion 612 formed adjacent to the second portion 606 and a fourth portion 614 formed adjacent to the third portion 612. The third portion 606 and the fourth portion 614 are formed into a cylindrical shape. The fourth portion 614 includes a male thread 616 formed at a distal end of the nose cone pin 114. The male thread 616 is configured to engage with the female thread 512 of the device holder 112.

[0067] Figure 7 An example of a storage tank 700 according to an embodiment thereof is shown. Those skilled in the art will recognize that Figure 7 An example of a storage tank is shown and Figure 7 Existing components shown in FIG. 700 may be removed and / or additional components may be added to storage tank 700 .

[0068] In an embodiment, an implantable medical device 116 can be loaded into the loading system 100. For example, the implantable medical device 116 can be coupled to the device holder 112, and the nose cone pin 114 can be secured to the device holder 112 by engaging the male threads 616 of the nose cone pin 114 with the female threads 514 of the device holder 112. The device holder 112, including the implantable medical device 116 and the nose cone pin 114, can be inserted into the loading funnel 108 and the locking ring assembly 102 (attached to the loading funnel 108) to partially compress the implantable medical device 116. For example, the device holder 112 can be inserted into the distal opening 306 of the loading funnel 108 and retracted through the loading funnel 108 into the loading channel 212 of the split ring 104. The funnel cap 110 can then be coupled to the loading funnel 108 by engaging the female threads 408 of the funnel cap 110 with the male threads 308 of the loading funnel 108.

[0069] Once the implantable medical device 116 is loaded into the loading system 100, the loading system 100 may be stored for a period of time until the implantable medical device 116 is used in surgery. To do so, the loading system 100 may be placed in a storage tank 700. The storage tank 700 may be filled with a preservation fluid 702. The preservation fluid 702 may be any type of fluid that maintains the integrity and quality of the loading system 100. For example, if the implantable medical device 116 includes an organic material, the preservation fluid 702 may include formaldehyde to maintain the integrity of the organic material.

[0070] Figure 8 and Figures 9A-9I Shown for operation Figure 1A and Figure 1BAn example of a process 800 of a loading system 100 for loading an implantable medical device into a delivery device is shown. Figure 8 and Figures 9A-9I Various operations that can be performed in process 800 are shown, but those skilled in the art will recognize that existing operations can be removed and additional operations can be added. Likewise, those skilled in the art will recognize that the order of operations can be changed in certain circumstances.

[0071] In step 802, process 800 includes removing the loading system from the storage tank. For example, the loading system 100 may be stored in the storage tank 700. The storage tank 700 may be opened and the loading system 100 removed, for example, as Figure 9A shown.

[0072] At step 804, process 800 includes flushing the loading system in a sterile bath. Figure 9B As shown, the loading system 100 with the implantable medical device 116 loaded therein can be placed in a sterile bath 902. The sterile bath 902 can include any suitable fluid, such as saline, to sterilize the loading system 100 and remove unwanted materials from the loading system 100. For example, the sterile bath 902 can be used to remove any preservation fluid 702 from the storage tank 700. When the loading system 100 is placed in the sterile bath 902 and agitated, the fluid of the sterile bath 902 cleans the exterior of the loading system 100. Similarly, the fluid of the sterile bath 902 can enter the interior of the loading system 100, for example, through the port 410, to clean the interior of the loading system 100 and the implantable medical device 116.

[0073] In step 806, process 800 includes attaching the delivery device to the device holder of the loading system. Figure 9C As shown, a delivery device 904 can be attached to the device holder 112. The delivery device 904 can include an outer shaft and an inner shaft disposed within the lumen of the outer shaft. The inner shaft can include male threads at its distal end that engage with the female threads 514 of the device holder 112. The outer shaft can be inserted into the split ring 104 of the locking ring assembly 102. The inner shaft can extend from the outer shaft and can be attached to the device holder 112, for example, by being screwed in.

[0074] In step 808, process 800 includes loading the valve into a capsule of a delivery device. In an embodiment, the capsule can be a distal portion of an outer shaft of the delivery device 904. Figure 9D and 9EAs shown, the inner shaft can be retracted into the outer shaft. As the inner shaft retracts, the device holder 112 also retracts into the outer shaft. Simultaneously, the implantable medical device 116 attached to the device holder 112 is retracted through the loading funnel 108 in the loading direction L. As the implantable medical device 116 moves through the compression volume 311, the inner surface of the loading funnel body 302 exerts a compressive force on the surface of the implantable medical device 116.

[0075] At step 810, process 800 includes removing the loading hopper of the loading system. Figure 9F As shown, the loading funnel 108 can be removed from the locking ring assembly 102. For example, the loading funnel 108 can be disengaged from the locking ring assembly 102. The partially compressed implantable medical device 116 exerts an outward spring force on the loading funnel 108, which pulls the loading funnel 108 upward against the locking ring assembly 102. This force can increase during loading until the locking ring assembly 102 exits the loading funnel 108, thereby releasing the loading funnel 108 from the locking ring assembly 102.

[0076] At step 812, process 800 includes removing the locking ring assembly of the loading system. Figure 9G As shown, the locking ring assembly 102 can be removed from the delivery device 904 in a single action. For example, the locking ring assembly 102 can be slid off the outer shaft of the delivery device 904. Similarly, in another example, the locking ring 106 can be removed from the split ring 104, and then the split ring 104 can be removed. For example, the split ring 104 can be detached from the locking ring 106, such as by unscrewing it, and the split ring 104 can be separated into the first half ring 202 and the second half ring 204.

[0077] In step 814, process 800 includes attaching the nose cone to the nose cone pin. For example, Figure 9H As shown, the nose cone 906 may be attached to the nose cone pin 114 by engaging the male threads 604 with the female threads of the nose cone 906 .

[0078] In step 816, process 800 includes sealing the capsule. Figure 9I As shown, the inner shaft can be further retracted into the outer shaft until the nose cone 906 engages and forms a seal with the outer shaft.

[0079] Figure 10A and 10B Another example of a loading system 1000 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 10A and 10B An example of a loading system is shown and Figure 10A and 10B Existing components shown in FIG. 100 may be removed and / or additional components may be added to loading system 1000 .

[0080] like Figure 10A As shown, the loading system 1000 includes a locking ring assembly 1002. The locking ring assembly 1002 includes a cap 1004 and a locking ring 1006. The loading system 1000 also includes a loading funnel 1008 and an integrated storage tank 1010. Figure 10B As shown, loading system 1000 includes a device holder 1012 and a nose cone pin 1014. Device holder 1012 secures an implantable medical device 1016. When coupled to loading system 1000, device holder 1012 is positioned within locking ring 1006 of locking ring assembly 1002. Nose cone pin 1014 is coupled to device holder 1012 and extends through loading funnel 1008. Loading system 1000 also includes a fluid port 1018.

[0081] The device holder 1012 is coupled to an implantable medical device 1016. As described above, any type of implantable medical device that needs to be converted from an uncompressed state to a compressed state and that needs to be loaded onto a delivery device can be used with the loading system 1000. In one embodiment, the implanted medical device 1016 can include a component intended to repair or support a human body system, such as an artificial heart valve that includes a stent / frame coupled to a self-expanding or balloon-expandable stent. For example, the loading system 1000 can be used on implantable medical devices that are to be delivered transluminally, for example, via a catheter, and need to be loaded onto or into a catheter. The stent / frame can be radially compressed to have a low profile and loaded into / onto the delivery device so that the heart valve prosthesis can be delivered to a target location through a blood vessel in a compressed state and then expanded at the target location, for example, via a self-expanding stent / frame or balloon of the delivery device, for example to replace a natural heart valve.

[0082] The loading system 1000 is configured to store the implantable medical device 1016 in a partially compressed or "loaded" state. That is, the loading funnel 1008 is configured to apply a force to the implantable medical device 1016 to partially compress the implantable medical device 1016 and maintain the implantable medical device 1016 in the partially compressed state during storage. In an embodiment, as further described below, the loading funnel 1008 is formed with a tapered lumen that maintains the implantable medical device 1016 in the partially compressed state and operates to further compress the implantable medical device 1016 when the implantable medical device 1016 is loaded onto a delivery device.

[0083] The locking ring assembly 1002 allows a delivery device, such as a catheter, to be attached to the device holder 1012 with minimal interaction with the implantable medical device 1016. In one embodiment, as further described below, the delivery device (or a component of the delivery device) is inserted into the locking ring assembly 1002 and coupled to the device holder 1012. To load the implantable medical device 1016, the device holder 1012 is retracted into the delivery device. As the device holder 1012 is retracted, the implantable medical device 116 is further compressed by the loading funnel 1008.

[0084] Although not described in further detail, device holder 1012, nose cone pin 1014, and implantable medical device 1016 may comprise the same components of device holder 112, nose cone pin 114, and implantable medical device 116, respectively, as described above.

[0085] Figure 11A and 11B An example of a locking ring 1006 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 11A and 11B An example of a locking ring is shown and Figure 11A and 11B Existing components shown in FIG. 1004 may be removed and / or additional components may be added to locking ring 1006 .

[0086] like Figure 11A As shown, locking ring 1006 includes a locking ring neck 1102 and a locking ring base 1104. Locking ring 1006 includes a proximal opening 1106 located in locking ring neck 1102 and a distal opening 1108 located in locking ring base 1104. Locking ring neck 1102 includes a circular channel 1110. Circular channel 1110 can be configured to receive a sealing member, such as an O-ring, that provides a fluid seal between locking ring neck 1102 and cap 1004.

[0087] like Figure 11BAs shown, locking ring neck 1102 includes a loading channel 1112. Loading channel 1112 extends from proximal opening 1106 to the top of locking ring base 1104. Loading channel 1112 is formed into a substantially cylindrical shape with a circular cross-section, having an inner diameter d1. Loading channel 1112 is formed with a diameter d1 to accommodate device holder 1012 and allow a delivery device, such as a catheter, to be inserted into locking ring neck 1102. In embodiments, diameter d1 of device channel 212 may depend on the FR size of the catheter. For example, diameter d1 of loading channel 212 may be formed to accommodate an 18-33 Fr catheter. In one embodiment, a delivery device may be inserted into proximal opening 1106, and device holder 1012 may be positioned at or near the bottom of locking ring neck 1102. Locking ring 1006 may be formed from any suitable material, such as, but not limited to, a polymeric material.

[0088] For example, the loading system 1000 can be configured to store and load 42 millimeter (mm) TMVR devices, such as heart valves and frames. In such an embodiment, the loading channel 1112 can be formed to have a diameter d1 in the range of about 6 mm to about 13 mm. In another example, the loading system 1000 can be configured to store and load 48 mm TMVR devices. In such an embodiment, the loading channel 1112 can be formed to have a diameter d1 in the range of about 6 mm to about 13 mm. Those skilled in the art will recognize that the loading channel 1112 can be formed to any size and / or cross-sectional shape to accommodate different medical devices and / or delivery devices.

[0089] like Figure 11B As shown, locking ring neck 1102 further includes a circular ridge 1113 located distal to loading channel 1112. Circular ridge 1113 extends radially inward from the inner surface of locking ring neck 1102. In one embodiment, circular ridge 1113 can be formed in a substantially annular and / or toroidal shape. Circular ridge 1113 is formed with a diameter d2 that is smaller than diameter d1 of loading channel 1112. In one embodiment, circular ridge 1113 can be formed with a diameter d2 that is larger than the diameter of device holder 1012 but smaller than the outer diameter of a delivery device, such as the diameter of an outer shaft of a delivery device to be inserted into locking ring neck 1102. In this embodiment, circular ridge 1113 can serve as a stopper to prevent the delivery device from being inserted through circular ridge 1113.

[0090] The locking ring base 1104 includes a female thread 1114. The female thread 1114 is formed at the bottom of the locking ring base 1104 near the distal opening 1108. The female thread 1114 is configured to mate with the loading funnel 1008 (at the bottom). Figure 13A and 13B1008 to secure the loading funnel 1008 to the locking ring 1006. The locking ring base 1104 also includes a cavity 1115. The cavity 1115 is formed by a first portion 1116 positioned adjacent to or near the distal opening 1108 and a second portion 1118 positioned adjacent to or near the distal end of the loading channel 1112. The first portion 1116 and the second portion 1118 are formed to match the shape and size of the loading funnel 1008, as further described below.

[0091] Figure 12A and 12B An example of a cap 1004 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 12A and 12B An example of a cap is shown and Figure 12A and 12B Existing components shown in FIG. 1004 may be removed and / or additional components may be added to cap 1004 .

[0092] like Figure 12A As shown, the cap 1004 includes a cap neck 1202 and a cap base 1204. The cap neck 1202 is formed into an approximately rectangular polygon. Figure 12B As shown, the cap base 1204 includes a cap opening 1206 leading to a cap channel 1208. The cap channel 1208 has a generally cylindrical shape with a circular cross-section and a diameter c that is approximately equal to or greater than the outer diameter of the cap neck 1202. For example, the cap channel 1208 may have a diameter c of approximately 15 mm and may have an overall height of approximately 40 mm. Figure 10A and 10B As shown, cap 1004 slides over cap neck 1202 to provide a fluid seal to loading channel 1112, for example, via a sealing member disposed in circular channel 1110. Cap 1004 may be formed from any suitable material, such as, but not limited to, a polymeric material.

[0093] Figure 13A and 13B An example of a loading hopper 1008 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 13A and 13B An example of a loading hopper is shown and Figure 13A and 13B Existing components shown in may be removed and / or additional components may be added to funnel 1008 .

[0094] like Figure 13AAs shown, the loading funnel 1008 includes a first portion 1302, a second portion 1304, a third portion 1306, a fourth portion 1308, and a fifth portion 1310. The loading funnel 1008 includes a proximal opening 1312 and a distal opening 1314. The loading funnel 1008 includes a ring 1316 formed at the proximal end of the second portion 1304 and adjacent to and / or near the third portion 1306. The ring 1316 is formed into a cylindrical shape extending radially outward from the outer surface of the second portion 1304. The loading funnel 1008 includes a male thread 1318. The male thread 1318 is formed on the first portion 1302 adjacent to and / or near the distal opening 1314. The male thread 1318 is configured to engage with the thread of the integrated storage tank 1010 (in the following Figures 14A-14C 1008) to secure the integrated storage tank 1010 to the loading funnel 1008. The ring 1316 can act as a stopper or seal when the integrated storage tank 1010 is attached to the loading funnel 1008. For example, the ring 1316 can include one or more large O-ring seals that can prevent liquid from leaking into the loading system 1000.

[0095] The loading funnel 1008 includes male threads 1320. The male threads 1320 are formed on the fourth portion 1308 adjacent to and / or near the proximal opening 1312. The male threads 1320 are configured to engage with the female threads 1114 of the locking ring 1006 to secure the loading funnel 1008 to the locking ring 1006. The loading funnel 1008 can be formed of any suitable material, such as, but not limited to, stainless steel.

[0096] The loading funnel 1008 is formed into an approximately conical shape, the diameter of the fifth portion 1310 is smaller than the diameter of the fourth portion 1308, and the diameter of the fourth portion is smaller than the diameters of the first portion 1302, the second portion 1304, and the third portion 1306. Figure 13BAs shown, the loading funnel 1008 forms a compressed volume 1321 within the loading funnel 1008. The compressed volume 1321 opens at a proximal opening 1312 and a distal opening 1314. The compressed volume 1321 is formed by a first chamber 1322, a second chamber 1324, and a third chamber 1326. The proximal opening 1312 is formed in the fifth portion 1310 having a diameter f1. The distal opening 1314 is formed in the first portion 1302 having a diameter f2. The interior of the loading funnel 1008 forms the compressed volume 1321. The compressed volume 1321 is formed into an approximately funnel-shaped or conical shape, with its volume decreasing from the first portion 1302 to the fifth portion 1310. In one embodiment, the compressed volume 1321 tapers in diameter from the diameter f2 at the distal opening 1314 to the diameter f1 at the proximal opening 1312. Each of first chamber 1322, second chamber 1324, and third chamber 1326 can be formed in the shape of a funnel, each having a varying degree of volume reduction from distal opening 1314 to proximal opening 1312. In embodiments, the volume of compression volume 1321 operates to maintain implantable medical device 1016 in a partially compressed state.

[0097] In embodiments, the degree of volume reduction, such as the taper angle, can affect the angle at which the implant attachment tab exits the funnel, with a longer taper improving loading of the implantable medical device 116. A longer taper can provide a smoother transition for the implantable medical device 116 during loading into the delivery device. A shorter taper can impose compressive strain on the implantable medical device 116, may require greater force during loading, may result in uneven crimping, may cause inflow of the implantable medical device 116, or may impose additional compressive loads on the implantable medical device 116 during storage. Depending on the degree of volume reduction, for example, the taper angle can be set to minimize these and ensure the integrity of the implantable medical device 116.

[0098] In embodiments, the reduced volume of compression volume 1321 also operates to exert a compressive force on implantable medical device 1016 as device holder 1012 is retracted through loading channel 1112. That is, as device holder 1012 is retracted into a delivery device positioned in loading channel 1112, implantable medical device 1016 is retracted through proximal opening 1312 in loading direction L. As implantable medical device 1016 moves through compression volume 1321, the inner surface of loading funnel 1008 exerts a compressive force on the surface of implantable medical device 1016.

[0099] In an embodiment, the diameter f1 of the proximal opening 1312 can be determined by the FR size of the catheter. For example, the diameter f1 of the proximal opening 1312 can be formed to accommodate an 18-33 Fr catheter. In an embodiment, the diameter f2 of the distal opening 1314 can be determined by the outer diameter of the implantable medical device 116.

[0100] In some embodiments, the loading system 100 can be configured to store and load 42 mm TMVR devices, and in such embodiments, the diameter f1 can be in the range of about 6 mm to about 13 mm, and the diameter f2 can be in the range of about 20 mm to about 60 mm.

[0101] For example, the loading system 1000 can be configured to store and load a 42 mm TMVR device, and the proximal opening 1312 can be formed with a diameter f1, and the distal opening 1314 can be formed with a diameter f2. In such an embodiment, the diameter f1 can be in the range of approximately 6 mm to approximately 13 mm, and the diameter f2 can be in the range of approximately 20 mm to approximately 60 mm. In another example, the loading system 1000 can be configured to store and load a 48 mm TMVR device, and the proximal opening 1312 can be formed with a diameter f1, and the distal opening 1314 can be formed with a diameter f2. In such an embodiment, the diameter f1 can be in the range of approximately 6 mm to approximately 13 mm, and the diameter f2 can be in the range of approximately 20 mm to approximately 60 mm. Those skilled in the art will recognize that the compression volume 1321 can be formed with any size and / or cross-sectional shape to accommodate different medical devices and / or delivery devices.

[0102] although Figure 11A 、 11B, 13A, and 13B illustrate threads for coupling the locking ring 1006 and the loading hopper 1008, but those skilled in the art will recognize that other types of connectors may be used to mechanically couple the locking ring 1006 and the loading hopper 1008. In some embodiments, the locking ring 1006 and the loading hopper 1008 may include a push-fit locking ring that provides an interference fit to couple the locking ring 1006 and the loading hopper 1008. For example, the outer diameter of the locking ring 1006 may be larger than the inner diameter of the loading hopper 1008. In some embodiments, the locking ring 1006 and the loading hopper 1008 may include a C-clip mechanism connector that provides mechanical interference between the locking ring 1006 and the loading hopper 1008. In some embodiments, the locking ring 1006 and the loading hopper 1008 may include a snap-fit ​​connection (e.g., cantilever, torsion, and / or annular). For example, the locking ring 1006 may include a protruding edge or tab, and the loading hopper 1008 may include an engaging area (e.g., a groove, channel, etc.) to receive and lock the protruding edge or tab. Likewise, for example, the loading funnel 1008 may include a protruding edge or tab, and the locking ring 1006 may include an engaging area (eg, a groove, a channel, etc.) for receiving and locking the protruding edge or tab.

[0103] Figures 14A-14C An example of an integrated storage tank 1010 according to an embodiment thereof is shown. Those skilled in the art will recognize that Figures 14A-14C An example of an integrated storage tank is shown and Figures 14A-14C Existing components shown in FIG. 10 may be removed and / or additional components may be added to the integrated storage tank 1010 .

[0104] like Figure 14A As shown, the integrated storage tank 1010 includes a tank body 1402. The tank body 1402 is formed into a generally cylindrical shape. The tank body 1402 includes a proximal opening 1404 and a distal opening 1406. The integrated storage tank 1010 includes female threads 1408. The female threads 1408 are formed at the proximal end of the tank body 1402, adjacent to or near the proximal opening 1404. The female threads 1408 are configured to engage with the male threads 1318 of the loading funnel 1008 to secure the integrated storage tank 1010 to the loading funnel 1008. The integrated storage tank 1010 can be formed from any suitable material, such as, but not limited to, a polymeric material.

[0105] The integrated storage tank 1010 includes a tank base 1410. The tank base 1410 includes an opening 1412. The opening 1412 is configured to receive a fluid port 1018. When the fluid port 1018 is inserted into the opening 1412, the tank base 1410 forms a fluid chamber 1413. The fluid chamber 1413 is configured to receive and retain a fluid, such as a preservation fluid and / or a sterile fluid, within the loading system 1000.

[0106] The integrated storage tank 1010 includes a nose cone pin retainer 1414. The nose cone pin retainer 1414 is configured to receive the nose cone pin 1014 and secure the nose cone pin 1014 in place when the integrated storage tank 1010 is attached to the loading funnel 1008. The nose cone pin retainer 1414 is formed into a generally cylindrical shape. The nose cone pin retainer 1414 is configured to secure the nose cone pin 1014 in place and prevent the nose cone pin 1014 from moving. That is, when the nose cone pin 114 is stored within the loading system 1000, the nose cone pin 114 abuts the bottom surface of the nose cone pin retainer 1414. The side walls of the nose cone pin retainer 1414 secure the nose cone pin 114 in place and prevent the nose cone pin 114 from moving laterally within the loading system 1000.

[0107] In an embodiment, nose cone pin retainer 1414 operates to prevent device holder 1012 and implantable medical device 1016 from exiting distal opening 1314 of loading hopper 1008. That is, nose cone pin retainer 1414 (e.g., a bottom surface) exerts a force on nose cone pin 1014 connected to device holder 1012 to prevent device holder 1012 and implantable medical device 1016 from sliding out of loading hopper 1008 due to the compressive force of loading hopper 1008 when implantable medical device 1016 is in a partially compressed state.

[0108] although Figure 13A 、 13B 14A-14C illustrate threads for coupling the loading hopper 1008 and the integrated storage tank 1010, but one skilled in the art will appreciate that other types of connectors may be used to mechanically couple the loading hopper 1008 and the integrated storage tank 1010. In some embodiments, the loading hopper 1008 and the integrated storage tank 1010 may include a push-fit locking ring that acts as an interference fit to couple the loading hopper 1008 and the integrated storage tank 1010. For example, the outer diameter of the loading hopper 1008 may be larger than the inner diameter of the integrated storage tank 1010. In some embodiments, the loading hopper 1008 and the integrated storage tank 1010 may include a C-clip mechanism connector that acts as mechanical interference between the loading hopper 1008 and the integrated storage tank 1010. In some embodiments, the loading hopper 1008 and the integrated storage tank 1010 may include a snap-fit ​​connection (e.g., cantilever, torsion, and / or annular). For example, the loading hopper 1008 may include a protruding edge or tab, and the integrated storage tank 1010 may include a snap-fit ​​area (e.g., a groove, a channel, etc.) for receiving and locking the protruding edge or tab. Likewise, for example, the integrated storage tank 1010 may include a protruding edge or tab, and the loading hopper 1008 may include a snap-fit ​​area (e.g., a groove, a channel, etc.) for receiving and locking the protruding edge or tab.

[0109] Figure 15A and 15B An example of a fluid port 1018 according to an embodiment thereof is shown. Those skilled in the art will appreciate that Figure 15A and 15B An example of a fluid port is shown and Figure 15A and Figure 15B Existing components illustrated in FIG. 10 may be removed and / or additional components may be added to the fluid port 1018 .

[0110] In an embodiment, the fluid port 1018 can operate as a Luer connector to allow a syringe to be attached. Figure 15A As shown, fluid port 1018 includes a port base 1502 and a port neck 1504. Port base 1502 is formed in an approximately cylindrical shape and includes a proximal opening 1506 formed at the proximal end of fluid port 1018. The port neck includes a distal opening 1508 formed at the distal end of the port neck. Port base 1502 includes a first base portion 1510 formed adjacent the proximal end of fluid port 1018 and a second base portion 1512 formed adjacent the first base portion 1510 and the distal end of port base 1502. Port base 1502 also includes a ridge 1514. Ridge 1514 operates to secure fluid port 1018 to opening 1412 of integrated reservoir 1010. For example, ridge 1514 may secure fluid port 1018 to opening 1412 via friction. In other embodiments, fluid port 1018 may be secured to opening 1412 using other types of connections, such as adhesives, welding, or threaded / screwed connections.

[0111] The port neck 1504 includes a first neck portion 1516 formed adjacent to the port base 1502, a second neck portion 1518 formed adjacent to the first neck portion 1516, and a third neck portion 1520 formed adjacent to the second neck portion 1518 and the distal end of the fluid port 1018. Each of the first neck portion 1516, the second neck portion 1518, and the third neck portion 1520 is formed in a generally cylindrical shape.

[0112] like Figure 15B As shown, fluid port 1018 includes fluid channel 1522. Fluid channel 1522 extends from proximal opening 1506 to distal opening 1508. Fluid channel 1522 allows fluid to be injected and extracted from loading system 1000. For example, a fluid delivery device, such as a syringe, can be attached to fluid port 1018 to extract and inject fluid.

[0113] In an embodiment, an implantable medical device 1016 can be loaded into the loading system 1000. For example, the implantable medical device 1016 can be coupled to the device holder 1012, and the nose cone pin 1014 can be secured to the device holder 1012 by engaging the male threads of the nose cone pin 1014 with the female threads of the device holder 1012. The device holder 1012, including the implantable medical device 1016 and the nose cone pin 1014, can be inserted into the loading funnel 1008 and the locking ring assembly 1002 (attached to the loading funnel 1008) to partially compress the implantable medical device 1016. For example, the device holder 1012 can be inserted into the distal opening 1314 of the loading funnel 1008 and retracted through the loading funnel 1008 into the loading channel 1112 of the locking ring 1006. The integrated storage tank 1010 may then be coupled to the loading funnel 1008 by engaging the female threads 1408 of the integrated storage tank 1010 with the male threads 1318 of the loading funnel 1008 .

[0114] In an embodiment, once the implantable medical device 1016 is loaded into the loading system 1000, the loading system 1000 can be stored for a period of time until the implantable medical device 1016 is used in surgery. The loading system 1000 can be filled with a preservation fluid via a fluid port 1018 in the integrated storage tank 1010. The preservation fluid can be any type of fluid that maintains the integrity and quality of the loading system 1000. For example, if the implantable medical device 1016 includes an organic material, the preservation fluid can include formaldehyde to maintain the integrity of the organic material.

[0115] Figure 16 and Figures 17A-17I Shown for operation Figure 10A and 10B An example of a process 1600 for loading an implantable medical device into a delivery system is shown. Figure 16 and Figures 17A-17I Various operations that may be performed in process 1600 are shown, but those skilled in the art will recognize that existing operations may be removed and additional operations may be added. Likewise, those skilled in the art will recognize that the order of the operations may be changed.

[0116] At 1602, process 1600 includes removing a cap from a loading system. For example, Figure 17A and 17B As shown, cap 1004 can be removed from loading system 1000. For example, a force can be applied to cap 1004 to extract cap 1004 from locking ring neck 1102.

[0117] At 1604, process 1600 includes attaching a fluid source to a fluid port of the loading system. At 1606, process 1600 includes flushing the loading system with a sterile solution. For example, Figure 17C As shown, syringe 1702 can be attached to fluid port 1018 of loading system 1000. Syringe 1702 can then be operated to introduce a sterile solution, such as saline, into loading system 1000 through fluid channel 1522. The saline can replace the preservation fluid contained in the loading system and clean the interior of loading system 1000.

[0118] At 1608, process 1600 includes attaching a delivery device to a device holder of a loading system. For example, Figure 17D As shown, a delivery device 1704 can be attached to the device holder 1012. The delivery device 1704 can include an outer shaft and an inner shaft that is retracted into the lumen of the inner shaft. The inner shaft can include male threads that engage with female threads of the device holder 1012. The outer shaft can be inserted into the locking ring neck 1102. The inner shaft can extend from the outer shaft and can be attached to the device holder 1012, for example, by being screwed in.

[0119] At 1610, process 1600 includes loading the valve into a capsule of a delivery device. In embodiments, the capsule may be a distal portion of an outer shaft of the delivery device 1704. Figure 17E and 17G As shown, the inner shaft can be retracted into the outer shaft. As the inner shaft retracts, the device holder 1012 also retracts into the outer shaft. Simultaneously, the implantable medical device 1016 is retracted through the loading funnel 1008 in the loading direction L. As the implantable medical device 1016 moves through the compression volume 1321, the inner surface of the loading funnel 1008 exerts a compressive force on the surface of the implantable medical device 1016. As the inner shaft retracts, additional sterile solution can be injected into the loading system 1000 using the syringe 1702.

[0120] At 1612, process 1600 includes removing the locking ring, loading funnel, and storage tank. Figure 17H As shown, the loading system 1000 can be removed from the locking ring neck 1102 as a single unit, for example, by sliding the outer shaft from the locking ring neck 1102.

[0121] At 1614, process 1600 includes attaching the nose cone to the nose cone pin. For example, Figure 17H As shown, the nose cone 1706 can be attached to the nose cone pin by engaging the male threads with the female threads of the nose cone 1706.

[0122] At 1616, process 1600 includes sealing the capsule of the delivery device. For example, Figure 17IAs shown, the inner shaft can be further retracted into the outer shaft until the nose cone 1706 engages and forms a seal with the outer shaft.

[0123] Additional discussion of various embodiments follows:

[0124] Example 1 is a device for storing and loading medical devices onto a delivery device. The device includes a locking ring assembly having a proximal end, a distal end, and a loading channel formed therebetween. The device also includes a loading funnel coupled to the distal end of the locking ring assembly at the proximal end of the loading funnel. The loading funnel is configured to store a collapsible medical device in a partially collapsed state within a conical interior volume of the loading funnel. The conical interior volume decreases from the distal end of the loading funnel to the proximal end of the loading funnel. The device includes a retainer positioned at the distal end of the locking ring assembly along with the loading channel and includes a connector configured to connect to a delivery device. The collapsible medical device can be coupled to the retainer. Prior to connection to the delivery device, the retainer holds the collapsible medical device within the loading funnel. The device also includes a nose cone pin coupled to the retainer and positioned within the conical interior volume of the loading funnel. The device also includes a storage tank coupled to the distal end of the loading funnel. The storage canister is configured to retain the collapsible medical device and the nose cone pin within the conical interior volume of the loading funnel.

[0125] Example 2 includes the apparatus of Example 1, and further includes a cap removably coupled to the locking ring assembly, wherein the cap and the reservoir retain fluid within the interior volume of the reservoir, the tapered interior volume of the loading funnel, and the loading channel of the locking ring assembly.

[0126] Example 3 includes the device of Example 2, wherein the locking ring assembly comprises a locking ring neck configured to receive the cap and a locking ring body comprising female threads formed on an inner surface of the locking ring body.

[0127] Example 4 includes the device of Example 3, wherein the loading funnel comprises: a male thread formed at a proximal end of the loading funnel, wherein the male thread is configured to engage the female thread of the locking ring body, and a male thread formed at a distal end of the loading funnel.

[0128] Example 5 includes a device according to Example 4, wherein the storage tank includes: a female thread formed at a proximal end of the storage tank, wherein the female thread is configured to engage a male thread formed at a distal end of the loading funnel to secure the storage tank to the loading funnel; and one or more fluid ports configured to selectively allow fluid to flow into and out of the interior volume of the storage tank and the loading funnel.

[0129] Example 6 includes the device of any of Examples 1-5, wherein the tapered interior volume comprises an approximately conical shape.

[0130] Example 7 includes the device of any of Examples 1-6, wherein the connector of the retainer comprises female threads configured to engage male threads of the delivery device.

[0131] Example 8 includes the device of any of Examples 1-7, wherein the collapsible medical device is an expansion frame comprising a heart valve.

[0132] Example 9 is a device for storing and loading medical devices onto a delivery device. The device includes a locking ring assembly having a proximal end, a distal end, and a loading channel formed therebetween. The device also includes a loading funnel coupled to the distal end of the locking ring assembly at the proximal end of the loading funnel. The loading funnel is configured to store a partially collapsed collapsible medical device within a conical interior volume of the loading funnel. The conical interior volume decreases from the distal end of the loading funnel to the proximal end of the loading funnel. The device also includes a retainer positioned at the distal end of the locking ring assembly along with the loading channel and including a connector configured to connect to the delivery device. The collapsible medical device is coupled to the retainer. Prior to connection to the delivery device, the retainer holds the collapsible medical device within the loading funnel. The device includes a nose cone pin coupled to the retainer and positioned within the conical interior volume of the loading funnel. The device also includes a funnel cap coupled to the distal end of the loading funnel. The funnel cap is configured to retain the collapsible medical device and the nose cone pin within the conical interior volume of the loading funnel.

[0133] Example 10 includes a device according to Example 9, wherein the locking ring assembly comprises: a split locking ring comprising a first half ring and a second half ring; and a locking ring detachably connected to a distal portion of the first half ring and the second half ring, wherein the locking ring secures the first half ring and the second half ring to the loading funnel to define a loading channel.

[0134] Example 11 includes the device of any of Examples 9-10, wherein the tapered interior volume comprises an approximately conical shape.

[0135] Example 12 includes the device of any of Examples 9-11, wherein the loading funnel includes male threads formed at a distal end of the loading funnel.

[0136] Example 13 includes a device according to Example 12, wherein the funnel cap comprises: a female thread formed at a proximal end of the funnel cap, wherein the female thread is configured to engage a male thread of the loading funnel to secure the funnel cap to the loading funnel; and one or more fluid ports configured to allow fluid to flow into and out of the interior volume of the loading cap and the loading funnel.

[0137] Example 14 includes the device of any of Examples 9-13, wherein the connector of the retainer comprises female threads configured to engage male threads of the delivery device.

[0138] Example 15 includes the device of any of Examples 9-14, wherein the collapsible medical device is an expansion frame comprising a heart valve.

[0139] Example 16 includes the device of any of Examples 9-15, wherein the device is configured to be held by a storage tank containing a preservation fluid.

[0140] Example 17 is a method for storing and loading a medical device onto a delivery device, the method comprising washing a collapsible medical device stored in a partially collapsed state within a conical interior volume of a loading device with a sterile solution. The method further comprises coupling the delivery device to a retainer positioned within the loading device. Prior to coupling to the delivery device, the retainer retains the collapsible medical device within the loading device in a partially collapsed state. Furthermore, the method comprises retracting the retainer through a loading channel of the loading device, wherein retracting the retainer causes the collapsible medical device to move through the conical interior volume to compress the collapsible medical device. The method comprises removing the loading device from the delivery device. The method further comprises sealing the collapsible medical device within the delivery device.

[0141] Example 18 includes the method of Example 17, wherein cleaning the collapsible medical device comprises: connecting a fluid delivery device to a fluid port of the loading device; and engaging the fluid delivery device to flow sterile fluid into the loading system.

[0142] Example 19 includes a method according to any of Examples 17-18, wherein cleaning the collapsible medical device comprises immersing the loading system in a bath containing the sterile fluid, wherein the loading system comprises one or more fluid ports configured to allow the sterile fluid to flow into and out of the loading device.

[0143] Example 20 includes the method of any of Examples 17-19, wherein sealing the collapsible medical device within the delivery device comprises attaching a nose cone to a nose cone pin connected to the retainer.

[0144] It should be understood that the various embodiments disclosed herein may be combined in combinations different than those specifically presented in the specification and drawings. It should also be understood that, depending on the example, the acts or events of any process or method described herein may be performed in a different order, may be added, combined, or excluded entirely (e.g., all described acts and events may not be necessary to perform the technique). Additionally, although certain aspects of the present invention are described as being performed by a single load or component for purposes of clarity, it should be understood that the techniques of the present invention may be performed by a combination of loads or components associated with, for example, a medical load.

Claims

1. A loading device for loading a medical device onto a delivery device, the loading device comprising: a loading funnel configured to store a collapsible medical device in a partially collapsed state within a tapered interior volume of the loading funnel, wherein the tapered interior volume decreases in volume from a distal end of the loading funnel to a proximal end of the loading funnel; a funnel cap coupled to the distal end of the loading funnel; a nose cone pin extending through the loading hopper; as well as A medical device holder is coupled to a proximal portion of the nose cone pin, the medical device holder configured to hold the collapsible medical device on a delivery device.

2. The device of claim 1, wherein fluid is able to flow into and out of the interior volume of the loading funnel and the funnel cap.

3. The device of claim 2, wherein the funnel cap comprises a fluid port configured to enable fluid to enter and exit the interior of the funnel cap.

4. The device of claim 2, wherein the loading funnel comprises male threads at the distal end of the loading funnel, wherein the male threads are configured to engage female threads of the funnel cap.

5. The device of claim 4, wherein the loading funnel comprises male threads at the distal end of the loading funnel, and wherein the funnel cap comprises female threads configured to engage the male threads at the distal end of the loading funnel to secure the funnel cap to the loading funnel.

6. The device of claim 1, wherein the nose cone pin has threads at a distal end thereof, the threads configured to couple with threads of a nose cone of a delivery device.

7. The device of claim 1, wherein the medical device holder has threads at its proximal end configured to couple with threads of an inner shaft of the delivery device.

8. The device of claim 1, wherein the funnel cap includes an opening that enables fluid to enter and / or exit the interior volume of the loading funnel.

9. The device of claim 1 , further comprising a locking ring assembly coupled to the proximal end of the loading funnel, wherein the locking ring assembly comprises a loading channel, wherein the medical device holder is positioned within the loading channel.

10. The device of claim 9, wherein the funnel cap comprises a fluid port configured to enable fluid to enter and exit the interior of the funnel cap.

11. The apparatus of claim 9, wherein the locking ring assembly comprises: a split locking ring comprising a first half ring and a second half ring; and A locking ring is removably coupled to the first and second half rings, wherein the locking ring secures the first and second half rings together to the loading hopper to define the loading channel.

12. A loading and storage system, comprising: collapsible medical devices; a loading funnel, wherein in a stored state, the collapsible medical device is partially collapsed within a tapered interior volume of the loading funnel, wherein the tapered interior volume decreases in volume from a distal end of the loading funnel to a proximal end of the loading funnel; a funnel cap coupled to the distal end of the loading funnel; a nose cone pin extending through the loading hopper; as well as A medical device holder is coupled to the proximal portion of the nose cone pin and to the collapsible medical device, the medical device holder being configured to be coupled to a delivery device.

13. The system of claim 12, wherein fluid is able to flow into and out of the interior volumes of the loading funnel and the funnel cap.

14. The system of claim 13, wherein the funnel cap includes a fluid port configured to enable fluid to enter and exit the interior of the funnel cap.

15. The system of claim 12, wherein the funnel cap includes an opening that enables fluid to enter and / or exit the interior volume of the loading funnel.

16. The system of claim 12, further comprising a locking ring assembly coupled to the proximal end of the loading funnel, wherein the locking ring assembly includes a loading channel, wherein the retainer is positioned within the loading channel.

17. The system of claim 16, wherein the funnel cap includes a fluid port configured to enable fluid to enter and exit the interior of the funnel cap.

18. The system of claim 16, wherein the locking ring assembly comprises: a split locking ring comprising a first half ring and a second half ring; and A locking ring is removably coupled to the first and second half rings, wherein the locking ring secures the first and second half rings together to the loading hopper to define the loading channel.

19. A method for storing a medical device and loading the medical device onto a delivery device, the method comprising: partially collapsing a collapsible medical device in a loading funnel, the loading funnel having a tapered interior volume that decreases in volume from a distal end of the loading funnel to a proximal end of the loading funnel; coupling a funnel cap to the distal end of the loading funnel; coupling the distal end of the nose cone pin to the nose cone; coupling a retainer to the proximal portion of the nose cone pin and the collapsible medical device; as well as Fluid is allowed to flow into the interior volume of the loading funnel and the funnel cap.

20. The method of claim 19, wherein fluid is able to flow into and out of the interior volumes of the loading funnel and the funnel cap.

21. The method of claim 19, wherein flowing fluid into the interior volume of the loading funnel and the funnel cap comprises placing the loading funnel with the collapsible medical device partially collapsed within the conical interior volume within a canister containing a preservation fluid.

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