JPWO2020010292A5 - - Google Patents

Description

Cross-reference to related applications This application claims the benefit of US Provisional Patent Application No. 62 / 649,660 filed July 6, 2018, and the entire disclosure of this related application is in its entirety. Incorporated herein by reference.

The present disclosure relates generally to the field of medical devices. More specifically, the present disclosure relates to storage devices, loading devices, supply systems, auxiliary devices, kits and related methods for implantable medical devices.

Various implantable medical devices have been developed that provide mechanisms for treating various disorders. For example, one potential clinical use of implantable valves is chronic venous insufficiency, where the natural valves in the veins of the lower extremities malfunction, resulting in reflux, increased venous pressure and decreased blood flow. Is to treat. Another clinical use of implantable valves is to treat pulmonary insufficiency, where the pulmonary valve is dysfunctional and allows regurgitation from the pulmonary artery to the right ventricle of the heart. Implantable valves may include mechanical structures and implantable materials. In certain valve structures, the valve implant material may require the implantable valve to be stored in a wet state to maintain the integrity of the implant material. For example, implantable valves can be stored in a chemical solution such as glutaraldehyde, in which case the solution needs to be rinsed off the implantable valve prior to implantation. .. The need for rinsing is a common practice in the field of bioprosthetic valves. For example, when the heart valve is stored in a solution such as glutaraldehyde or formaldehyde, the valve is removed from the storage container, rinsed off in a bowl of saline at the patient's bedside, and before the implantation procedure. It is a common practice to be loaded into the supply system, which increases the likelihood of contamination of implantable medical equipment.

Therefore, there is a need for new and useful storage devices, loading devices, supply systems, auxiliary devices, kits and related methods.

Various storage devices, loading devices, supply systems, kits and methods are described herein.

An exemplary storage device includes a storage member, a first cap, and a second cap. The storage member has a first end, a second end, a first opening, a second opening, a passageway, a separation wall, and a body defining a plurality of holes. The passageway extends from the first opening to the second opening and has a first portion and a second portion. The separation barrier extends into the passageway at a location between the first and second ends. The first portion of the passageway extends from the first end of the storage member to the separation wall, and the second portion of the passageway extends from the second end of the storage member to the separation wall. The second part is sized and configured to accommodate implantable medical devices. Each hole of the plurality of holes extends through the separation barrier and provides access between the first part of the passageway and the second part of the passageway. The first cap is releasably attached to the first end of the storage member. The second cap is releasably attached to the second end of the storage member.

An exemplary loading device includes a storage member, a first cap, a loading member, and a second cap. The storage member has a first end, a second end, a first opening, a second opening, a passageway, a separation wall, and a body defining a plurality of holes. The passageway extends from the first opening to the second opening and has a first portion and a second portion. The separation barrier extends into the passageway at a location between the first and second ends. The first portion of the passageway extends from the first end of the storage member to the separation wall, and the second portion of the passageway extends from the second end of the storage member to the separation wall. The second part is sized and configured to accommodate implantable medical devices. Each hole of the plurality of holes extends through the separation barrier and provides access between the first part of the passageway and the second part of the passageway. The first cap is releasably attached to the first end of the storage member. The loading member is releasably mounted on the second end of the storage member, and has a first end, a second end, a first opening, a second opening, and a first to second opening. It has a body that defines a passageway that extends to. The passageway of the loading member has a first portion, a second portion, a third portion, and a fourth portion. The first portion of the passageway of the loading member extends from the first end of the loading member to the second portion of the passageway of the loading member and has a first inner diameter. The second part of the passageway of the loading member extends from the first part of the passageway of the loading member to the third part of the passageway of the loading member, and from the first part of the passageway of the loading member to the third part of the passageway of the loading member. It has a second inner diameter that is tapered to. The third portion of the passageway of the loading member extends from the second portion of the passageway of the loading member to the second end of the loading member, and has a third inner diameter smaller than the first inner diameter of the first portion of the passageway of the loading member. Have. The fourth portion of the passageway of the loading member extends from the third portion and has a width larger than the third inner diameter of the third portion of the passageway. The second cap is releasably attached to the second end of the loading member.

An exemplary supply system includes a sheath, an elongated member, a tip, and a grip member. The sheath has a first end, a second end, a length, and a body defining the lumen. The length of the sheath extends from the first end to the second end. The lumen extends throughout the length of the sheath. The elongated member has a longitudinal axis, a first end, a second end, a body defining the outer surface, and a notch. The notch extends from the outer surface into the body of the elongated member towards the second end of the elongated member at an angle greater than 0 degrees with respect to the longitudinal axis. The tip is disposed on the second end of the elongated member and has a first end and a second end. The gripping member is attached to an elongated member between the notch and the first end of the tip. The gripping member has a first end, a second end, a length, and a body. The grip member is sized and configured to be disposed within the sheath. The notch is disposed between the first end of the elongated member and the gripping member.

An exemplary kit includes a storage device, a device guard, a supply system, and a loading member. The storage device includes a storage member, a first cap, and a second cap. Another exemplary kit includes a loading device, a device guard, and a supply system. The loading device includes a storage member, a first cap, a loading member, and a second cap.

Exemplary methods of disinfecting implantable medical devices include inserting the implantable medical device into the storage member, attaching the first cap to the storage member, and disinfecting the disinfectant material into the storage member. It includes a step of introducing, a step of introducing the holding material into the storage member so that the disinfectant material is removed from the storage member, and a step of attaching the second cap to the storage member.

Exemplary methods of storing implantable medical devices include inserting a disinfected implantable medical device into the storage member, attaching a first cap to the storage member, and storing the holding material. It includes a step of introducing into the member and a step of attaching the second cap to the storage member.

An exemplary method of rinsing an implantable medical device is to attach the device containing the rinse material to one valve of the storage device and to introduce the rinse material into the storage device so that it passes through the storage device. A step of stopping the step of introducing the rinsed material into the storage device.

Exemplary methods of loading implantable medical equipment onto the supply system include removing the cap from the storage component containing the implantable medical device, removing the diffuser from the storage component, and device guard. A step of attaching the storage member to the storage member, a step of removing the second cap, a step of attaching the storage member to the loading member of the guide system, and a step of passing through the storage member and partially disposed in the device guard. A step of applying an axial force to a portion of the supply system, a step of positioning the loading puller within a notch defined by an elongated member of the supply system, and a step of moving and filling the loading puller into its open configuration. A step of applying an axial force to the elongated member of the supply system to move away from the storage member until it is free from the implantable medical device, a step of removing the loading puller from the supply system and the loading member, and the sheath loading. The step of applying an axial force to the sheath of the supply system towards the loading member while maintaining the position of the elongated member until the point of contact with the member, the elongated member retracting from the loading member, and the medical device sheathing. Includes a step of applying an axial force to the elongated member while maintaining the position of the sheath to advance inward and a step of removing the supply system from the loading member.

Another exemplary method of loading implantable medical devices onto a supply system is to remove the cap from the storage component containing the implantable medical device, and to remove the diffuser from the storage component. A step of attaching the device guard to the storage member, a step of applying an axial force to a portion of the supply system so that it passes through the storage member and is partially disposed within the device guard, and an elongated supply system. Axial forces on the elongated member of the supply system until the step of positioning the loading puller within the notch defined by the member and the point at which the loading puller moves into its open configuration and is free from implantable medical devices. And the step of removing the loading puller from the feeding system and the loading member, and the axis to the sheath of the feeding system towards the loading member while maintaining the position of the elongated member until the sheath comes into contact with the loading member. A step of applying a directional force and a step of applying an axial force to the elongated member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Includes steps to remove the supply system from the loading member.

Another exemplary method of loading an implantable medical device onto a supply system is the step of obtaining an implantable medical device with an attached loading puller, and the implantable medical device and loading from a container. A step to remove the puller, a step to rinse off the implantable medical device and the loading puller, a step to advance the loading assister through the passageway defined by the loading member, and a step to attach the loading assister to the loading puller. A step of retracting the loading assister from the loading member, a step of removing the loading assister from the loading puller, a step of attaching the device guard to the loading member, and a step of passing through the loading member and partially disposed within the device guard. The step of applying an axial force toward the loading member to the elongated member of the feeding system, the step of positioning the loading puller in the notch defined by the elongated member of the feeding system, and the first of the loading pullers. A step of applying an axial force away from the loading member to the elongated member of the feeding system, and the feeding system and loading, until the first and second ends are disposed within the fourth portion of the loading member. The step of removing the loading puller from the member and the step of applying an axial force toward the loading member to the sheath of the supply system while maintaining the position of the elongated member until the sheath contacts the loading member. A step of applying an axial force away from the loading member to the elongated member while maintaining the position of the sheath so that the member retracts from the loading member and the medical device advances into the sheath, and loading. Includes a step of removing the supply system from the component.

Further understanding of exemplary storage devices, loading devices, supply systems, auxiliary devices, kits and related methods can be obtained by reviewing the following detailed description and accompanying drawings.

FIG. 3 is an exploded cross-sectional view of a first exemplary storage device acquired along a longitudinal axis of a storage member. It is an end view of the storage member shown in FIG. It is a perspective view of the storage member shown in FIG. FIG. 3 is a partial cross-sectional view of a second exemplary storage device acquired along a longitudinal axis of a storage member. It is a perspective view of the apparatus guard shown in FIG. It is an exploded sectional view of the 3rd exemplary storage apparatus acquired along the longitudinal axis of a storage member. It is a perspective view of the storage member shown in FIG. It is an exploded perspective view of the 4th exemplary storage device. FIG. 8 is an exploded cross-sectional view of the storage device shown in FIG. 8 acquired along the longitudinal axis of the storage member. It is an end view of the storage member shown in FIG. It is a perspective view of the storage member shown in FIG. 11 is an enlarged view of Area I-I shown in FIG. It is a perspective view of the diffuser shown in FIG. FIG. 8 is another perspective view of the diffuser shown in FIG. It is a front view of the 5th exemplary storage device. It is sectional drawing of the storage apparatus shown in FIG. 15 acquired along the longitudinal axis of a storage member. FIG. 16 is a plan view of the loading puller shown in FIG. FIG. 3 is a partial plan view of a loading puller mounted on a implantable medical device. It is a partially disassembled sectional view of the 1st exemplary loading apparatus acquired along the longitudinal axis of a loading member. It is a front view of the 2nd exemplary loading device. FIG. 18 is an exploded cross-sectional view of the loading device shown in FIG. 18, acquired along the longitudinal axis of the storage member. It is a perspective view of the loading member shown in FIG. FIG. 18 is another perspective view of the loading member shown in FIG. It is an end view of the loading member shown in FIG. FIG. 18 is an end view of the second cap shown in FIG. It is a perspective view of the storage member shown in FIG. It is a perspective view of the 1st cap shown in FIG. It is a perspective view of the connector shown in FIG. It is a partial front view of the first exemplary supply system. It is an enlarged view of the area II-II shown in FIG. 27. It is a partial front view of the second exemplary supply system. FIG. 3 is a partial perspective view of a third exemplary supply system. FIG. 3 is a perspective view of an alternative tip that may be included on an elongated member of the feeding system. It is a front view of the tip shown in FIG. FIG. 3 is a perspective view of another alternative tip that may be included on an elongated member of the feeding system. It is an end view of the tip shown in FIG. 32A. FIG. 3 is a perspective view of an alternative device guard that may be included on a storage device or loading device. FIG. 32C is an end view of the device guard shown in FIG. 32C. It is a perspective view of an exemplary guide system. It is a top view of the guide board shown in FIG. 33. It is a perspective view of a part of the loading member shown in FIG. 33. FIG. 33 is a perspective view of another portion of the loading member shown in FIG. 33. It is a perspective view of a part of the guide member shown in FIG. 33. FIG. 33 is a perspective view of another portion of the guide member shown in FIG. 33. An exemplary kit including a storage device is shown. An exemplary kit including a loading device is shown. FIG. 3 is a schematic representation of an exemplary method of disinfecting a implantable medical device. FIG. 6 is a cross-sectional view of a implantable medical device stored in an exemplary storage member. FIG. 3 is a schematic representation of another exemplary method of disinfecting a implantable medical device. FIG. 6 is a cross-sectional view of a implantable medical device stored in an exemplary storage member. FIG. 3 is a schematic representation of an exemplary method of preserving a implantable medical device. FIG. 3 is a schematic representation of an exemplary method of rinsing a implantable medical device. It is a schematic of an exemplary method of loading an implantable medical device onto a supply system. It is sectional drawing of the storage member attached to the loading member of a guide system. It is an enlarged view of the area III-III shown in FIG. 46. FIG. 6 is a cross-sectional view of a supply system partially disposed within a device guard and a loading puller disposed within a notch defined by an elongated member. It is an enlarged view of the area IV-IV shown in FIG. 47. It is sectional drawing of the loading puller in an open structure. It is an enlarged view of the area VV shown in FIG. 48. It is sectional drawing of the sheath which comes into contact with a loading member. It is an enlarged view of the area VI-VI shown in FIG. 49. FIG. 3 is a schematic representation of another exemplary method of loading implantable medical devices onto a supply system. FIG. 6 is a cross-sectional view of a supply system partially disposed within a device guard and a loading puller disposed within a notch defined by an elongated member. It is an enlarged view of the area VII-VII shown in FIG. 51. FIG. 6 is a cross-sectional view of a supply system partially disposed within a device guard and a loading puller disposed within a notch defined by an elongated member. The loading puller is in an open configuration. It is an enlarged view of the area VIII-VIII shown in FIG. 52. FIG. 3 is a cross-sectional view of a supply system partially disposed within a device guard and a sheath in contact with a loading member. It is an enlarged view of the area IX-IX shown in FIG. 53. It is a partial perspective view of the 4th exemplary supply system. FIG. 3 is a perspective view of an alternative device guard that can be used with a loading member. It is a perspective view of an exemplary loading assister. It is a partial front view of the loading assister shown in FIG. 56. FIG. 3 is a plan view of another exemplary loading puller. It is a front view of the loading puller shown in FIG. 58. FIG. 58 is a plan view of the loading puller shown in FIG. 58 mounted on a implantable medical device. It is a perspective view of another exemplary loading member. It is an end view of the loading member shown in FIG. 61. It is another end view of the loading member shown in FIG. 61. It is sectional drawing of the loading member shown in FIG. 61 acquired along the longitudinal axis of a loading member. Another cross-sectional view of the loading member shown in FIG. 61, taken along the longitudinal axis of the loading member. Another cross-sectional view of the loading member shown in FIG. 61, taken along the longitudinal axis of the loading member. FIG. 3 is a schematic representation of another exemplary method of loading implantable medical devices onto a supply system. It shows a loading assister that is partially disposed through the loading member and is releasably mounted on a loading puller that is free from the loading member. Implantable medical devices are releasably mounted on the loading puller. It shows a loading assister that is free from the loading member and is releasably mounted on a loading puller partially disposed within the loading member. The implantable medical device is releasably mounted on the loading puller and is generally disposed within the loading member. The loading puller partially disposed in the loading member is shown. The implantable medical device is releasably mounted on the loading puller and is generally disposed within the loading member. The device guard is releasably attached to the loading member. Shown are loading pullers that are partially disposed within the loading member and disposed within a notch defined by an elongated member of the supply system. The implantable medical device is releasably mounted on the loading puller and is generally disposed within the loading member. The device guard is releasably attached to the loading member.

The following detailed description and accompanying drawings describe and illustrate various exemplary embodiments of storage devices, loading devices, supply systems, auxiliary devices, kits and methods. Descriptions and illustrations of these examples are provided to allow one of ordinary skill in the art to manufacture and use storage devices, loading devices, supply systems, auxiliary devices, manufacture kits, and implement methods. Is. These are by no means intended to limit the scope of the claims.

As used herein, the term "diameter" means the length of a straight line that passes from one side to the other through the center of a body, element or feature, and is arbitrary with respect to the body, element or feature. It does not give a structural structure.

As used herein, the term "periphery" means the boundaries surrounding a body, element or feature and does not confer any structural configuration with respect to the body, element or feature.

1, FIG. 2 and FIG. 3 show a first exemplary storage device 10 including a storage member 12, a first cap 14, and a second cap 16. In the illustrated embodiment, each of the first cap 14 and the second cap 16 is releasably attached to the storage member 12.

The storage member 12 includes a longitudinal axis 13, a first end 20, a second end 22, a peripheral wall 26, a first opening 28, a second opening 30, a passage way 32, a separation wall 34, and a plurality of holes. It has a main body 24 that defines 36. The passage way 32 extends from the first opening 28 to the second opening 30 and extends from the first end 20 to the separation wall 34 through the storage member 12, from the first portion 38 and the second end 22. It has a second portion 40 extending to the separation wall 34. The first portion 38 has a first inner diameter 39. The second portion 40 is in the separation wall 34, which is more than 39 smaller than the first inner diameter so that the second portion 40 is tapered from the second end 22 to the separation wall 34 (eg, to form a partial cone). It has a second inner diameter 41 and a third inner diameter 43 at the second end 22 that is equal to the first inner diameter 39. In the illustrated embodiment, the second portion 40 is sized and configured to accommodate an implantable medical device, as described in more detail herein. The separation wall 34 extends within the passageway 32 at a location between the first end 20 and the second end 22 positioned relatively close to the first end 20. The separation wall 34 defines a through hole 42 having an inner diameter 45 smaller than the second inner diameter 41 of the second portion 40. Each hole of the plurality of holes 36 extends through the separation wall 34 and allows fluid that has passed through the storage member 12 to pass through on the outer and inner surfaces of the medical device disposed within the second portion of the passageway 40. It provides access between the first portion 38 of the passageway 32 and the second portion 40 of the passageway 32 so that it can pass through the holes 42 and / or the plurality of holes 36. Each hole of the plurality of holes 36 is equally separated from the adjacent holes of the plurality of holes 36, and is arranged at the same distance from the peripheral wall 26 with respect to the other holes of the plurality of holes 36.

Although the storage member 12 is shown to have a particular structural configuration, the storage member can have any suitable structural configuration and is suitable for the storage member. The choice of can be based on various considerations, including the type of implantable medical device intended to be stored within the storage component. For example, the passageway 32 is shown to have a first portion 38 and a second portion 40, but the passageway defined by the body of the storage member is one, at least one, two, plural, or three. It can have any suitable number of parts, such as four and any other number deemed appropriate for a particular embodiment. The second portion 40 is illustrated as having a second inner diameter 41 at the separation wall 34 that is smaller than the first inner diameter 39 and a third inner diameter 43 at the second end 22 that is equal to the first inner diameter 39. , The second portion can have any suitable inner diameter. For example, the second portion is equal to, less than, greater than or equal to the first inner diameter of the first portion, equal to, less than, greater than or equal to the second inner diameter and / or first inner diameter of the separation barrier. It can have an equal third inner diameter at the second end. The separation wall 34 is shown to be positioned relatively close to the first end 20, where the separation wall is any suitable location between the first and second ends of the storage member. Can be positioned to. For example, the separation wall can be placed in the center of the storage member between the first and second ends, or can be positioned relatively close to the second end of the storage member. .. In the storage member 12, each hole of the plurality of holes 36 is equally separated from the adjacent holes of the plurality of holes 36, and the storage member 12 is arranged at the same distance from the peripheral wall 26 with respect to the other holes of the plurality of holes 36. As such, although illustrated as defining a plurality of holes 36, the storage member can include any suitable number of holes positioned in any suitable orientation. Examples of the number of holes considered appropriate for the body of the storage member to demarcate on the separation barrier are one, at least one, two, plural, three, four, five, five and more. Includes more than 10 and any other number deemed appropriate for a particular embodiment. An example of a position that is considered appropriate for arranging multiple holes is that each hole of the multiple holes is equally or irregularly separated from the adjacent holes of the multiple holes, and is plural. Includes those that are disposed at the same or different distances from the peripheral wall with respect to other holes in the hole.

Each of the first cap 14 and the second cap 16 is sized and configured to be releasably mounted on the storage member 12. The first cap 14 is releasably attached to the first end 20 of the storage member 12, and the second cap 16 is releasably attached to the second end 22 of the storage member 12. When attached to the storage member 12, each of the first cap 14 and the second cap 16 seals the passage way 32 defined by the storage member 12. In the illustrated embodiment, each of the first cap 14 and the second cap 16 is provided by the storage member 12 in order to realize a releasable attachment between the storage member 12 and the first and second caps 14, 16. Define the thread that joins the defined thread.

The first cap 14 is shown to be coupled to the storage member 12, and the second cap 16 is shown to be coupled to the storage member 12. The cap and the second cap can be attached to the storage member by using any appropriate attachment technique or method, and of the appropriate attachment technique or method between the cap and the storage member. The choice may be based on various considerations, including one or more materials forming the cap and / or storage member. Appropriate between the cap and the storage member, between the storage member and any other component, between the loading member and any other component and / or between the two components described herein. Examples of mounting techniques and methods that are considered are screw connections, avoiding rotation of storage components (eg, to avoid destruction of implantable medical devices stored within the storage device when the cap is fitted). Use of threaded connections, snap-fit mounts, one or more connectors, one or more coupling slots and protrusions, one or more Includes sealed coupling, tapered mounting (eg, molding taper) and the use of any mounting technique or method deemed appropriate for a particular application.

4 and 5 show another exemplary storage device 110. The storage device 110 is similar to the storage device 10 shown in FIGS. 1, 2 and 3 and described above, except as detailed below. The storage device 110 includes a storage member 112, a first cap 114, and a second cap 116. In the illustrated example, each of the first cap 114 and the second cap 116 is a storage member 112 to provide a releasable snap fit fit between the storage member 112 and the first and second caps 114, 116. Defines the structure to be combined with the structure defined by.

In the illustrated embodiment, the storage member 112 includes a port 121 extending from the main body 124 and a first two-way valve 123 mounted on the port 121. In addition, the second cap 116 defines a passageway 125 that extends through the body of the second cap 116 that communicates with the second two-way valve 127. This structural configuration complicates disinfection, storage, rinsing and / or loading of implantable medical devices, disinfecting and / or rinsing implantable medical devices stored within the storage device 110. And provides a mechanism for minimizing the risks associated with the handling of implantable medical devices intended to be positioned within the storage device. In one alternative embodiment, the port 121, the first two-way valve 123, the passageway 125 and / or the second two-way valve 127 may be omitted.

In the illustrated embodiment, the first cap 114 is a device guard 146 that is releasably attached to the first end 120 of the storage member 112 and partially extends within the passageway 132 defined by the storage member 112. include. The device guard 146 has a longitudinal axis 147, a first end 148, a second end 150, and a body 152 defining a base 154, a first protrusion 156, a second protrusion 158, and a recess 160. The base 154 is disposed between the first end 148 and the second end 150 and is sized and configured to be releasably mounted within the passageway 132 of the storage member 112. In the illustrated embodiment, the base 154 has an outer diameter 155, a first side portion 162, and a second side portion 164, and uses a snap fit fit between the device guard 146 and the storage member 112. It is sized and configured to be releasably mounted on the storage member 112 in the passageway 132. Accordingly, the storage member 112 and the device guard 146 define a coupling structure that provides a releasable snap-fit fit between the storage member 112 and the device guard 146.

The first protrusion 156 extends from the first side portion 162 to the first end portion 148, and the second protrusion 158 extends from the second side portion 164 to the second end portion 150. The first protrusion 156 has an outer diameter 157 that is tapered from the base 154 to the first end 148, which positions a implantable medical device between the first protrusion 156 and the storage member 112. Provides a mechanism for. The second protrusion 158 has a first outer diameter 149 at the base 154, a second outer diameter 151 between the base 154 and the second end 150, and a third outer diameter 153 at the second end 150. The second outer diameter 151 is smaller than the first outer diameter 149, and the third outer diameter 153 is smaller than the second outer diameter 151. The recess 160 extends from the first end 148 towards the second end 150 to the recess base 166 and is sized and configured to accommodate a portion of the supply system, as will be described in more detail below. .. The recess 160 has a first portion 168, a second portion 170, and a third portion 172. The first portion 168 has an inner diameter 167 that increases from the first end portion 148 to the second portion 170. The second portion 170 has an inner diameter of 169 tapered from the first portion 168 to the third portion 172. The third portion 172 has an inner diameter 171 smaller than the inner diameter 169 of the second portion 170. Each of the first portion 168 and the second portion 170 has a partial conical configuration, and the third portion 172 is disposed within the third portion 172 as described in more detail herein. When sized and configured to be coupled to a portion of the supply system (eg, tip 1516) such that a portion of the supply system is rotatably secured to the device guard 146. In the illustrated embodiment, the third portion 172 is sized and configured to be coupled to a portion of the tip of the feeding system (eg, the flat surface 1572 of the tip 1516), as further detailed herein. Also, a flat surface 173 extending from the second portion 170 to the recess base 166 is defined. When mounted on the storage member 112, the device guard 146 is positioned such that the first projection 156 extends through the through hole 142 of the separation wall 134. In use, the device guard 146 acts as a mechanical stop to advance of the supply system through the storage member, as further detailed herein.

Although the device guard 146 is shown to have a particular structural configuration, the device guard can have any suitable structural configuration and is a suitable structural configuration for the device guard. The choice of can be based on various considerations, including the type of implantable medical device in which the device guard is intended to be implanted using its component storage device. For example, the device guard 146 is shown as a single component, but the device guard is a plurality of components (eg, base, first protrusion, second protrusion) that are either releasably mounted or fixedly mounted to each other. ), While the first protrusion can have a constant outer diameter along its length, and the second protrusion can have a constant outer diameter along its length. It is possible to have and / or the first portion can have a constant inner diameter from the first end to the second end. Each of the first portion 168 and the second portion 170 is shown to have a partial conical configuration, and the third portion 172 is a flat surface 173 extending from the second portion 170 to the recess base 166. Although shown as having, the recess defined by the device guard can have any suitable configuration. For example, the recess can define any structural configuration sized and configured to accommodate any suitable portion of the supply system (eg, a portion of the tip, the entire tip) and / or. When disposed within the device guard, a portion of the supply system can be rotatably secured to the device guard. The device guard 146 is shown to be releasably mounted on the storage member 112, but any device guard, such as those described herein (eg, device guard 715, device guard 1714). , Can be releasably attached to the storage member.

6 and 7 show another exemplary storage device 210. The storage device 210 is similar to the storage device 10 shown in FIGS. 1, 2 and 3 and described above, except as detailed below. The storage device 210 includes a storage member 212, a first cap 214, and a second cap 216.

In the illustrated embodiment, the second portion 240 has a first inner diameter 239 such that the second portion 240 has a constant inner diameter 241 from the separation wall 234 to the second end 222 (eg, to produce a cylinder). It has a second inner diameter 241 at the same separation wall 234. In addition, each of the holes of the plurality of holes 236 defined by the body 224 of the storage member 212 is not equally separated from the adjacent holes of the plurality of holes 236 and with respect to the other holes of the plurality of holes 236. It is arranged at a different distance from the peripheral wall 226. The main body 224 of the storage member 212 has first and second protrusions 276 and 278 extending from the peripheral wall 226, a first passage way 280 extending through the first protrusion 276, and a second passage way extending through the second protrusion 278. Delimits 282. The protrusions 276, 278 and passageways 280, 282 are with the loading member and / or the guide member so that the storage member 212 can be releasably mounted on the loading member and / or the guide member, as further described herein. It is sized and configured to combine. The storage member 212 is shown to include a particular structural configuration to provide releasable attachment to the loading member and / or guide member, but is optional to achieve such releasable attachment. Appropriate structure can be used. Any embodiment of the storage member described herein allows the storage member to be releasably mounted on the loading member and / or the guide member, as described in more detail herein. And / or can optionally include one or more protrusions (eg, protrusions 276, 278) and one or more passageways (passageways 280, 282) for use with the guide system.

In the illustrated embodiment, the second cap 216 is releasably attached to the second end 222 of the storage member 212. The second cap 216 has a longitudinal axis 283, a first end 284, a second end 286, and a body 288 defining a recess 290 extending within the second cap 216. The recess 290 has a first portion 292 and a second portion 294 and extends to the recess base 296. The first portion 292 extends from the first end portion 284 toward the second end portion 286 and has a first inner diameter 291. The second portion 294 has a second inner diameter 293 that extends from the first portion 292 to the recess base 296 and is tapered from the first portion 292 to the recess base 296.

8, FIG. 9, FIG. 10, FIG. 11, FIG. 12, FIG. 13 and FIG. 14 show another exemplary storage device 310. The storage device 310 is similar to the storage device 210 shown in FIGS. 6 and 7 and described above, except as detailed below. The storage device 310 includes a storage member 312, a first cap 314, a second cap 316, a first one-sided valve 410, a second one-sided valve 412, and a diffuser 414.

In the illustrated embodiment, the inner diameter of the second portion 340 of the storage member 312 is the second in the separation wall 334 that positions the peripheral wall 326 within the second portion 340 of the passageway 332 so as to partially block the plurality of holes 336. It has 2 inner diameters 341. As shown in FIGS. 10, 11 and 12, the main body 324 of the storage member 312 defines a plurality of recesses 416. Each recess of the plurality of recesses 416 extends into the peripheral wall 326 to the recess base 418 and extends from the separation wall 334 toward the second end 322. In the illustrated embodiment, each recess of the plurality of recesses 416 extends to the second end 322. Each recess of the plurality of recesses 416 communicates with one hole of the plurality of holes 336, and in the recess base 418 which is larger than the first width 415 and the first width 415 in the separation wall 334 in the recess base 418. It has a second width 417 between the separation wall 334 and the second end 322. By positioning each recess of the plurality of recesses 416 so as to be adjacent to and communicate with the holes of the plurality of holes 336, the storage member 312 passes from the first one-sided valve 410 toward the second one-sided valve 412. The resulting fluid can flow through the plurality of holes 336 and in the plurality of recesses 416 in order to increase the amount of fluid in contact with any implantable medical device disposed within the storage member 312. The through holes 342 defined by the body 324 of the storage member 312 are sized and configured to accommodate a portion of the diffuser 414, as described in more detail herein.

Each recess of the plurality of recesses 416 extends from the separation wall 334 to the second end 322, communicates with one hole of the plurality of holes 336, and the separation wall 334 in the recess base 418. The first width 415 in the above and the second width 417 between the separation wall 334 and the second end 322 in the recess base 418, which is larger than the first width 415, are shown, but each recess is , Can have any suitable structural configuration. The choice of the appropriate structural configuration for each recess contained in the storage member depends on various considerations, including the structural configuration of the implantable medical device intended to be disposed within the storage member. It can be based. For example, storage components may be one, at least one, two, plural, three, four, five, more than five, more than ten, and any other that are considered appropriate for a particular embodiment. Any suitable number of recesses, such as the number of recesses, can be defined. The recess included on the storage member can extend by any suitable length of the storage member. For example, each recess in one recess or multiple recesses can be from the separation wall to the second end of the storage member, from the separation wall to the location between the separation wall and the second end, from the separation wall to the second end. From the location between the portions to the second end, from the first location between the separation wall and the second end to the second location between the first location and the second end, and in particular embodiments. It can be extended by any other length of storage material that is deemed appropriate for. The recess contained on the storage member can have any suitable width along its length. For example, the recesses of one recess or recesses each have a first width at the first end of the recess base (eg, at a separation wall) and more than, less than, equal to, or nearly equal to the first width. It can have a second width (eg, between the separation wall and the second end) at the second end of the recess base. The recesses contained on the storage member have any suitable structural configuration, such as curved, cubic, prismatic and any other structural configuration, which is considered appropriate for a particular embodiment. be able to.

In the illustrated embodiment, the second cap 316 is releasably attached to the second end 322 of the storage member 312. The passageway 390 of the second cap 316 has a first portion 392, a second portion 394, a third portion 396, and a fourth portion 398. The first portion 392 extends from the first end portion 384 toward the second end portion 386 and has a first inner diameter 391. The second portion 394 has a second inner diameter 393 that extends from the first portion 392 to the third portion 396 and is tapered from the first portion 392 to the third portion 396. The third portion 396 has an inner diameter 395 that extends from the second portion 394 to the fourth portion 398 and is tapered from the second portion 394 to the fourth portion 398. The fourth portion 398 extends from the third portion 396 to the second end 386, and as described in more detail herein, the fluid passes through the passageway 390 to the second one-way valve 412. It has an inner diameter of 397 that is sized and configured to allow.

In the illustrated embodiment, the first cap 314 has a first end 420, a second end 422, and a body 424 defining the passage way 426 and the recess 428. The passageway 426 extends from the first end 420 to the recess 428 and is sized and configured to allow fluid to pass through the passageway 426. The first one-sided valve 410 is releasably mounted on the first end 420 of the first cap 314, and the second one-sided valve 412 is releasably mounted on the second end 386 of the second cap 316. Each of the first and second one-way valves 410 and 412 has a first opening 430 and a second opening 432 and is adapted to allow fluid to pass through the valve in one direction. ing. In the illustrated embodiment, the first one-way valve 410 is adapted to allow fluid to pass through the valve from the first opening 430 to the second opening 432, and the second one-way valve 412 is fitted with the fluid. It is adapted to allow passage through the valve from the second opening 432 to the first opening 430. Alternatively, the first one-way valve can be adapted to allow fluid to pass through the valve from the first opening to the second opening or from the second opening to the first opening. And / or the second one-way valve can be adapted to allow fluid to pass through the valve from the first opening to the second opening or from the second opening to the first opening. In an alternative embodiment, the first one-sided valve and / or the second one-sided valve can be omitted from the storage device and / or the loading device as described in more detail herein, and the first cap is. , The recess can be defined and the inclusion of the passage way can be omitted, the second cap can define the recess and the inclusion of the passage way can be omitted. Yes and / or the loading member can define the recess and omit the inclusion of the passage way. Alternatively, the first and / or second one-way valves can be omitted from the storage and / or loading device, as described in more detail herein, and have one fluid or more. A cap is first placed to seal the passageway defined by the first cap, the passageway defined by the second cap, and / or the passageway defined by the loading member so that it cannot pass through the plurality of passageways. It can be disposed on the first end of the cap, the second end of the second cap and / or the second end of the loading member. Alternatively, the first one-way valve and / or the second one-way valve can be omitted from the storage and / or loading device, as further detailed herein, and the first two-way valve and / or the second one-way valve and / Or the second two-way valve may be included in the storage device and / or the loading device in place of any other one-way valve. Alternatively, the first and / or second one-sided valves contained within the storage device can also be permanently secured to the cap, within the recess defined by the storage device cap or other component. It can also be arranged.

The diffuser 414 is releasably disposed in the first portion of the passageway 332 and the through hole 342 of the separation wall 334. As shown in FIGS. 13 and 14, the diffuser 414 has a first end 434, a second end 436, a base 438, and a frame 440. The base 438 extends from the second end 436 towards the first end to the frame 440 and is sized and configured to be accepted by the through holes 342 of the separation wall 334. The base 438 has an outer diameter 439 equal to the inner diameter of the through hole 342 (eg, such that the diffuser seals the through hole 342). However, alternative embodiments may include a diffuser having a base having an outer diameter that is less than, greater than, or substantially equal to the inner diameter of the through hole. The storage member 312 and the diffuser 414 define a coupling structure that provides a snap-fit fit between the base 438 of the diffuser 414 and the separation wall 334 of the storage member 312. The frame 440 extends from the base 438 to the first end 434 and defines a plurality of struts defining a plurality of openings 446 sized and configured to allow fluid to pass through the frame 432 in use. It has 442. The diffuser 414 passed through the storage member 312 in use so that the fluid could pass through the plurality of holes 336 and / or through holes 342 in embodiments where the base 438 of the diffuser 414 did not seal through holes 342. A mechanism for supplying a fluid is provided. In an alternative embodiment, the diffuser can be omitted from the storage and / or loading device, as described in more detail herein.

Although the diffuser 414 is shown to have a particular structural configuration and to be releasably disposed within the first portion of the storage member, the diffuser shall have any suitable structural configuration. And can be positioned within the storage member at any suitable location. The selection of the appropriate structural configuration for the diffuser and the appropriate location for positioning the diffuser within the storage component is based on various considerations, including the structural configuration of the storage component in which the diffuser is located. Can be. Examples of suitable locations for positioning the diffuser within the storage component are such that the diffuser is releasably disposed within the first portion of the storage device, releasably within the second portion of the storage device. Those that are disposed, those that are permanently or releasably attached to the caps of the storage device (eg, first cap, second cap), those that are permanently or releasably (eg, first of the passageways). Includes those such as those mounted on storage members (within a portion, within the second portion of the passageway) as well as any other location deemed appropriate for a particular embodiment.

The storage device 310 reduces the complexity of disinfection, storage, rinsing and / or loading of implantable medical devices and the risks associated with handling implantable medical devices intended for implantation. Provides a mechanism for minimizing. For example, the storage device 310 disinfects, stores, and rinses implantable medical devices using a closure system that reduces interaction with implantable medical devices during disinfection, storage, rinsing and / or loading. And / or provide a mechanism for loading.

15, 16 and 16A show another exemplary storage device 510. The storage device 510 is shown in FIGS. 8, 9, 10, 10, 11, 12, 13, and 14, and is similar to the storage device 310 described above, except as detailed below. ing. The storage device 510 includes a storage member 512, a first cap 514, a second cap 516, a first one-sided valve 610, a second one-sided valve 612, a diffuser 614, an implantable medical device 650, and loading. Includes puller 652 and.

In the illustrated embodiment, the implantable member device 650 includes a frame 654 and a material 656 mounted on the frame 654. The implantable medical device 650 implants the fluid as it passes through the first portion 538 of the storage member 512 and into the second portion 540 through the plurality of holes 536 and through holes 542 of the separation wall 534. It is disposed within a second portion 540 of the storage member 512 so that it can pass over the outer and inner surfaces of a possible medical device 650.

In the illustrated embodiment, the loading puller 652 is releasably mounted on a implantable medical device 650 and is partially disposed within each of the storage member 512 and the second cap 516. The loading puller 652 has a longitudinal axis 657, a first end 658, a second end 660, a length 661, a first bend 664, a second bend 666, a third bend 668 and a fourth. It has a main body 662 that defines a bent portion 670. The loading puller 657 is sized and configured to join a notch defined by an elongated member of the supply system, as detailed herein. When the loading puller 652 is releasably mounted on the implantable medical device 650, the loading puller has two hooked ends 672, 674 that partially surround a portion of the frame 654 of the implantable medical device 650. The first bent portion 664 is positioned in the vicinity of the first end portion 658 between the first end portion 658 and the second bent portion 666, and the fourth bent portion 670 is the second end. It is positioned in the vicinity of the second end portion 660 between the portion 660 and the third bent portion 668. The first hooked end 672 is positioned opposite to the second hooked end 674 with respect to the longitudinal axis 657 of the loading puller 652. The second bent portion 666 is arranged between the first bent portion 664 and the third bent portion 668 so that the loading puller 652 defines the U-shaped member 676, and the third bent portion 668 is It is arranged between the second bent portion 666 and the fourth bent portion 670. The loading puller 652 is movable between a first uncompressed or open configuration and a second compressed or closed configuration. In a closed configuration, the loading puller 652 is between the hooked ends 672, 674, which is smaller than the outer diameter of the implantable medical device so that the loading puller 652 can be releasably mounted on the implantable medical device. It has an arranged width. In the closed configuration, as shown in FIG. 16B, a portion of the loading puller 652 (eg, hooked ends 672, 674) will have the loading puller 652 when an axial force is applied to the loading puller 652. , Disposed within one or more openings 651 defined by a frame of the implantable medical device 650 so as to have the ability to apply an axial force to the implantable medical device 650. .. In the open configuration, the loading puller 652 was disposed between hooked ends 672, 674, which is larger than the outer diameter of the implantable medical device so that the loading puller is free from the implantable medical device. Has a width. In the illustrated embodiment, the loading puller 652 is urged to an open configuration.

Although the loading puller 652 has been shown to have a particular structural configuration, the loading puller provides a releasable attachment to a implantable medical device, as further detailed herein. And can have any suitable structural configuration capable of advancing implantable medical devices through storage and / or loading devices. The selection of the appropriate structural configuration for the loading puller may be based on various considerations such as the structural configuration of the implantable medical device in which the loading puller is intended to be fitted. For example, the loading puller 652 is shown to have a first hooked end 672 positioned opposite the second hooked end 674 with respect to the longitudinal axis 657 of the loading puller 652. The first hooked end can be positioned at any suitable location relative to the second hooked end with respect to the longitudinal axis of the loading puller. Although the loading puller 652 is shown as defining four bends, the loading puller can define any number of bends. Examples of the number of bends considered appropriate for the defined loading puller are one, at least one, two, plural, three, four, five, more than five and for certain embodiments. Includes any other number deemed appropriate. For example, the loading puller can define only the first and second bends to define the first and second hooked ends, and the first hooked end is the second hooked end. A curve defined between the first bent portion and the second bent portion can be included so as to be positioned on the opposite side of the portion. Alternatively, the loading puller can also define only the first, second and third bends to define the first and second hooked ends, and the third bend is the first. It can also be defined between the first bend and the second band so that the one hooked end is positioned on the opposite side of the second hooked end.

The loading puller 652 can be formed from any suitable material and using any manufacturing method, and the selection of the appropriate material and manufacturing method is that the loading puller is releasably mounted. It can be based on various considerations, including the materials that form the intended implantable medical device. Examples of materials considered suitable for forming loading pullers are biocompatible materials, materials that may have biocompatibility, metals, shape memory alloys, Nitinols, plastics and conforming to specific embodiments. Includes any other material that is considered to be. In the illustrated embodiment, the loading puller is made from Nitinol.

FIG. 17 shows an exemplary loading device 710. The loading device 710 includes a loading member 712, a first cap 714, a second cap 716, a implantable medical device 718, and a loading puller 720. The implantable medical device 718 is similar to the implantable medical device 650 shown in FIGS. 15 and 16 and described above, except as detailed below. The loading puller 720 is similar to the loading puller 652 shown in FIGS. 15 and 16 and described above, except as detailed below.

In the illustrated embodiment, the loading member 712 is a body 726 defining a longitudinal axis 721, a first end 722, a second end 724, a first opening 728, a second opening 730 and a passageway 732. And have. The passageway 732 extends from the first opening 728 to the second opening 730 and has a first portion 734, a second portion 736, a third portion 738, and a fourth portion 740. The passageway 732 is sized and configured to accommodate a implantable medical device 718. The first portion 734 extends from the first end portion 722 to the second portion 736 and has an inner diameter of 735. The second portion 736 has an inner diameter 737 that extends from the first portion 734 to the third portion 738 and is tapered from the first portion 734 to the third portion 738. The third portion 738 extends from the second portion 736 toward the second end. In the illustrated embodiment, the third portion 738 extends from the second portion 736 to the second end 724 and has a first cross-sectional configuration obtained along a plane orthogonal to the longitudinal axis 721 (eg, circular). It has an inner diameter 739 smaller than the inner diameter 735 of the first portion 734). The fourth portion 740 extends from the third portion 738 (eg, the location between the second end 724 and the second end 736) to the second end 724 and is along a plane orthogonal to the longitudinal axis 721. Has a second cross-sectional structure (eg, elongated cross-sectional structure, rectangular cross-sectional structure) obtained above, and is larger than the inner diameter 739 of the third portion 738 and smaller than the inner diameter 735 of the first portion 734 of the passageway 732. It has a width 741 (measured on a plane orthogonal to the longitudinal axis 721). In use, as the loading puller 720 moves through the second portion 736 of the passageway 732 as it is pulled through the passageway 732, the loading puller 720 is in its closed configuration and the implantable medical device 718. It is in its compressed configuration. When the loading puller 720 reaches the fourth portion of the passageway 732, the loading puller expands into its open configuration, while the implantable medical device 718 remains in its compressed configuration. The implantable medical device 718 is shown to be disposed within the first portion 734 of the passageway 732, whereas the implantable medical device is disposed within any suitable portion of the loading member. can do. Depending on the structural configuration of the implantable medical device intended to be positioned within the loading device, the passageway can have any suitable structural configuration. For example, various parts of the passageway can have any suitable cross-sectional composition such as circular, elongated, elliptical, rectangular, etc., and a part of the passageway has a constant inner diameter, along the length of the part. Inner diameter that varies along the length of the portion (eg, tapered towards a location between the first and second ends towards the second or second end). The shoulder is defined within the portion so that the first inner diameter is between the first end and the shoulder and the second inner diameter larger than the first inner diameter is between the shoulder and the second end. ) Or any other configuration that is considered suitable for a particular embodiment.

The second cap 716 is releasably attached to the second end 724 of the loading member 712, and has a first end 742, a second end 744, and a body 746 defining the recess 748 and the recess base 750. Have. The recess 748 has a first portion 752 and a second portion 754. The first portion 752 has a first inner diameter 753, and the second portion 754 has a second inner diameter 755 that is smaller than the first inner diameter 753 of the first portion 752. The second portion 754 is sized and configured to accommodate a portion of the loading puller 720. The second cap 716 and the loading member 712 define a coupling structure that realizes snap-fit mounting between the second cap 716 and the loading member 712.

In the illustrated embodiment, the first cap 714 is releasably mounted on the first end 722 of the loading member 712 and partially extends within the passageway 732 defined by the loading member 712, the device guard 715. including. The device guard 715 has a first end 756, a second end 758, and a body 760 defining a base 762, a side wall 764, a protrusion 766 and a recess 768 extending within the protrusion 766. The base 762 and side walls 764 co-define a cavity 770 sized and configured to accommodate a portion of the loading member 712. The protrusion 766 extends from the base 762 through the cavity 770 to the environment outside the cavity 770. The recess 768 extends from the second end 758 toward the first end 756 to the recess base 769. The recess 768 is sized and configured to accommodate a portion of the supply system, as further detailed herein. The device guard 715 is shown to be releasably mounted on the loading member 712, but any suitable device guard such as those described herein (eg, device guard 146, device guard 1714). ) Or caps such as those described herein (eg, cap 14) can be releasably attached to the loading member. An alternative embodiment has an opening or hollow extension on the first end that is above or equal in length to the tip of the supply system or is sized and configured to accommodate a portion of the tip of the supply system. Can include device guards, including protrusions, that define.

In the illustrated embodiment, the loading puller 720 is releasably mounted on a implantable medical device 718 and is partially disposed within each of a loading member 712 (eg, passageway 732) and a second cap 716. ing. In embodiments that include first and second tracks, the loading puller is partially located within the passageway defined by the loading member, first track and second track, as further detailed herein. It is set up.

Optionally, the loading device includes a port (eg, port 121), a first two-way valve (eg, valve 123), a passageway defined on the first cap (eg, passageway 426), and a second cap. A passageway defined above (eg, passageway 125) and a second two-way valve (eg, valve 127) can be included. In these embodiments, the implantable medical device can be positioned within the loading member (eg, the first portion of the passageway), and the cap is on the loading member as described. Can be positioned. As a result, if not already disinfected, the implantable medical device can be implanted by passing the disinfectant material through the loading member using the first and second two-way valves and any suitable component mounted on the valve. For disinfection, disinfectant material can be passed through the loading component using the port. After disinfection, to rinse off implantable medical devices by passing the rinse-off material through the loading member using the first and second two-way valves and any suitable component mounted on the valve. The port can be used to pass the rinse material through the loading component. Hold to preserve implantable medical devices by optionally passing the holding material through the loading member using the first and second two-way valves and any suitable component mounted on the valve. The material can be passed through the loading component using the port. This structural configuration, as described herein, is by any component of the implantable medical device until the time the supply system is used to supply the implantable medical device. Provides a mechanism for disinfecting, rinsing and storing implantable medical devices to prevent contact.

The loading device 710 reduces the complexity of disinfection, rinsing and / or loading of implantable medical devices and risks associated with the handling of implantable medical devices intended to be implanted. It provides a mechanism for minimization. For example, the loading device 710 disinfects, stores, rinses implantable medical devices using a closure system that reduces interaction with implantable medical devices during disinfection, storage, rinsing and / or loading. Provides a mechanism for dropping and / or loading.

18, 19, FIG. 20, FIG. 21, FIG. 22, FIG. 23, FIG. 24, FIG. 25 and FIG. 26 show another exemplary loading device 810. The loading device 810 includes a storage member 812, a first cap 814, a first one-way valve 910, a second one-sided valve 912, a diffuser 914, a loading member 1012, a second cap 1014, a connector 1016, and loading. Includes puller 1020 and. Each of the storage member 812, the first cap 814, the first one-way valve 910, the second one-way valve 912, and the diffuser 914, respectively, except for the contents detailed below, are shown in FIGS. 8, 9, and 10. It is similar to the storage member 312, the first cap 314, the first one-way valve 410, the second one-sided valve 412 and the diffuser 414 shown in FIGS. 11, 12, 13 and 14, and described above. Each of the loading member 1012 and the second cap 1014 is similar to the loading member 712 and the cap 714 shown in FIG. 17 and described above, respectively, except for the contents detailed below.

As shown in FIGS. 19 and 24, the body 824 of the storage member 812 defines first and second posts 1074, 1076, ridges 1078, and recesses 1079. Each of the first and second posts 1074, 1076 extends from the first end 820 and to the end 1073 away from the second end 822. Each of the posts 1074, 1076 has a first outer diameter 1075 at the end 1073 of the post and a second outer diameter 1077 between the end of the post and the first end 820 of the first cap 812. .. The second outer diameter is smaller than the first outer diameter. Each ridge 1078 extends away from the second end 822 and away from the first end 820 and is accepted by the recess 1098 defined by the loading member 1012 as shown in FIG. The size is set and configured in. The recess 1079 extends from the outer surface into the body 824 and toward the longitudinal axis 813 of the storage member 812. The recess 1079 is sized and configured to accommodate a portion of the connector 1016, as further detailed herein.

As shown in FIGS. 19 and 25, the diffuser 914 is permanently attached to the first cap 814, the first one-sided valve 910 is permanently attached to the first cap 814, and the first cap. The 814 define first and second openings 1080, 1082, respectively, sized and configured to accommodate a portion of the posts 1074, 1076 defined by the storage member 812. The openings 1080, 1082 of the first portion 1084, which is sized and configured to accommodate a portion of the post 1074, 1076 having a first outer diameter 1075, and the posts 1074, 1076, which have a second outer diameter 1077. It has a second portion 1086 which is sized and configured to accept a portion. In use, the first cap 814 is placed on the storage member 812 such that the first post 1074 is disposed in the first opening 1080 and the second post 1076 is disposed in the second opening 1082. It is positioned. After the posts 1074, 1076 are positioned within the openings 1080, 1082, the first cap 814 is the length of the storage member 812 to provide a releasable fit between the storage member 812 and the first cap 814. It rotates about the direction axis 813 with respect to the storage member 812.

In the illustrated embodiment, the loading member 1012 is releasably mounted to the storage member 812 using the connector 1016, and the body 1026 of the loading member 1012 has a plurality of recesses 1088, a first track 1090, and a second. The track 1092, the first and second posts 1094, 1096, the plurality of recesses 1098, and the recesses 1099 are defined. Each recess of the plurality of recesses 1088 extends from the first end 1022 to the second end 1024 of the loading member 1012 and joins between the first portion 1034 and the second portion 1036 of the passageway 1032. It is finished in the department. Each recess of the plurality of recesses 1088 has a first width 1087 at the first end 1022 of the loading member 1012 and a second width 1089 between the first end 1022 and the second end 1024. The first width 1087 is larger than the second width 1089 so that each recess of the plurality of recesses is tapered from the first end 1022 to the second end 1024. Each of the first track 1090 and the second track 1092 passes through the first portion 1034, the second portion 1036 and a part of the passageway 1032 from the first end 1022 of the loading member 1012 into the main body 1026, respectively, and the fourth portion of the passageway 1032. It extends to 1040 and is sized and configured to accommodate a portion of the loading puller 1020. Each of the first and second trucks 1090 and 1092 provides a mechanism for guiding the loading puller 1020 through the loading member 1012 in use. Each of the first and second posts 1094 and 1096 extends from the second end 1024 of the loading member 1012 and to the end 1093 away from the first end 1022. Each of the posts 1094 and 1096 has a first outer diameter of 1095 at the end of the post 1093 and a second outer diameter of 1097 between the end of the post 1093 and the second end 1024 of the loading member 1012. The second outer diameter 1097 is smaller than the first outer diameter 1095. Each recess 1098 extends from the first end 1022 into the body 1026 of the loading member 1012 and is sized and configured to accommodate the ridge 1078 defined by the storage member 812. When the ridge 1078 is received in the recess 1098, the plurality of recesses 916 defined by the storage member 812 are aligned with the plurality of recesses 1088 defined by the loading member 1012. The recess 1099 extends into the body 1026 from the outer surface and towards the longitudinal axis 1021 of the loading member 1012. The recess 1099 is sized and configured to accommodate a portion of the connector 1016, as further detailed herein.

Each recess of the plurality of recesses 1088 extends from the first end 1022 of the loading member 1012 toward the second end 1024 and joins between the first portion 1034 and the second portion 1036 of the passageway 1032. A first width 1087 at the first end of the loading member 1012 and a second width 1089 between the first end 1022 and the second end 1024, which is smaller than the first width 1087. Although shown as having, each recess can have any suitable structural configuration. The selection of the appropriate structural configuration for each recess contained within the loading member is based on various considerations, including the structural configuration of the implantable medical device intended to pass through the loading member. Can be For example, the loading member is one, at least one, two, plural, three, four, five, five or more, more than ten, and any other that is deemed appropriate for a particular embodiment. Any suitable number of recesses, such as a number, can be defined. The recess contained on the loading member may extend to any suitable length of the loading member. For example, each recess of one recess or a plurality of recesses is from the first end to the second end of the loading member, between the first end to the first end and the second end of the loading member. From place to place, from place between the first and second ends of the loading member to the second end, from place 1 to place 1 between the first and second ends of the loading member It may extend to a second location between and the second end, and by any other length of the loading member deemed appropriate for a particular embodiment. The recess contained on the loading member can have any suitable width along its length. For example, the recesses of one recess or recesses each have a first width at the first end (eg, at the first end of the loading member) and more than, less than, equal to, or nearly equal to the first width. It can have an equal second width (eg, between the first and second ends of the loading member) at the second end. The recesses contained on the loading member have any suitable structural configuration, such as curved, cubic, prismatic, and any other structural configuration deemed appropriate for a particular embodiment. be able to.

In the illustrated embodiment, the second cap 1014 is releasably mounted on the second end 1024 of the loading member 1012, and the second one-sided valve 912 is permanently attached to the second end 1044 of the second cap 1014. It is installed. However, alternative embodiments may include a cap that incorporates a one- or two-way valve within the cap so that a separate component mounted on the cap is not required. The body 1046 of the second cap 1014 extends through the second end 1044 and defines a passageway 1102 that provides access to the recess 1048. As shown in FIG. 23, the second cap 1014 has first and second openings 1104, 1106, respectively sized and configured to accommodate a portion of posts 1094, 1096 defined by the loading member 1012, respectively. Is defined. Each opening 1104, 1106 has a first outer diameter 1095, a first portion 1108 sized and configured to accommodate a portion of the post 1094, 1096, and a second outer diameter 1097, a post 1094, It has a second portion 1110 sized and configured to accept a portion of the 1096. In use, the second cap 1014 is placed on the loading member 1012 such that the first post 1094 is disposed in the first opening 1104 and the second post 1096 is disposed in the second opening 1106. It is positioned. After the posts 1094 and 1096 are positioned within the openings 1104 and 1106, the second cap 1014 is the length of the loading member 1012 to provide an releasable fit between the loading member 1012 and the second cap 1014. It rotates with respect to the loading member 1012 about the direction axis 1021.

The connector 1016 is releasably attached to the storage member 812 and the loading member 1012. The connector 1016 has a longitudinal axis 1113, a first end 1114, a second end 1116, and a body 1118 defining the first projection 1120 and the second projection 1122. Each of the first protrusion 1120 and the second protrusion 1122 extends from the main body 1118 and toward the longitudinal axis 1113 of the connector 1016. The first protrusion 1120 is sized and configured to be received by the recess 1079 defined by the storage member 812, and the second protrusion 1122 is sized and configured to be received by the recess 1099 defined by the loading member 1012. It is configured. The connector 1016 provides a releasable fit between the storage member 812 and the loading member 1012. In one alternative embodiment, the connector can be omitted and the storage member uses any suitable method or technique for achieving releasable attachment, such as those described herein. Thereby, it can be directly attached to the loading member. Alternatively, the connector can be permanently attached to the storage and loading members (eg, using crimp connections).

Any of the storage and / or loading devices described herein can optionally include implantable medical devices housed within a second portion of the storage member. Any suitable implantable medical device can be included within the storage component, and the selection of a suitable implantable medical device will include a variety of treatments intended to be performed. It can be based on considerations. Examples of implantable medical devices that are considered appropriate for inclusion within storage components are implantable medical devices, including frames such as support frames, frames and implantable materials that include material attached to the frame. Includes frame with medical devices, venous valves, heart valves, stents, leaflets or transplant material lacking openings that are sutured to each other or otherwise fitted to permanently close the associated valve openings. Includes closure plugs and any other implantable medical device deemed appropriate for a particular embodiment.

Examples of frames that are considered appropriate for inclusion on implantable medical devices include those that include an inflatable frame that is radially compressed and has a configuration that expands in the radial direction. Such frames are sized and configured for navigation within the body's blood vessels, by minimally invasive techniques such as supply and deployment by supply systems such as those described herein. It can be implanted at the point of treatment within the blood vessel. Regardless of the type and / or characteristics of the frame, implantable medical devices such as frames can be supplied by the relevant supply system, such as those described herein, by surgical techniques, or within body blood vessels. Implantation within a body vessel at the desired point of treatment using conventional minimally invasive techniques, such as by any other suitable technique for placing the frame or medical device at the point of treatment. Keep in mind that you can.

The frame may be self-expandable or may require an input of force to achieve expansion, such as a balloon inflatable frame. The frame can provide a stenting function, i.e., a radial outward force can be exerted on the inner wall of the frame or the blood vessel in which the implantable medical device containing the frame is implanted. By including such a force-acting frame, implantable medical devices can provide multiple functions, such as stent and valve function, at the point of treatment within the body's blood vessels. It may be desirable in certain situations, such as when a predetermined degree of vascular stenosis, occlusion and / or weakening is present.

The frame of the implantable medical device is a conventional structural that facilitates mooring of the frame at any suitable structural element such as struts and bends, and points of treatment within the body's blood vessels such as barbs and / or microbarbs. Features can include structural features such as radiopaque markers that facilitate frame visualization in conventional or other medical visualization techniques such as radiography, fluorescence fluoroscopy and other techniques. In addition, the frame can include structural features such as small holes, barbs, strips and other suitable structures that provide mounting points for transplantation and other materials.

The frame can be manufactured from any suitable material, and the selection of the appropriate material for use within the frame according to a particular embodiment is a variety of including any desired flexibility and visualization properties. It can be based on considerations. The material selected for the frame only needs to be or may be biocompatible. Examples of suitable materials are, without limitation, stainless steel, nickel titanium (NiTi) alloys such as Nitinol, other shape memory and / or superelastic materials, molybdenum alloys, tantalum alloys, titanium alloys, noble metal alloys, etc. Includes Nickel Chromium Alloys, Cobalt Chromium Alloys, Nickel Cobalt Chromium Alloys, Nickel Cobalt Chromium Molybdenum Alloys, Nickel Titanium Chromium Alloys, Linear Elastic Nitinol Wires, Polymer Materials and Composite Materials. Absorbable and bioreconstructable materials can also be used to form the frame. As used herein, the term "absorbable" means the ability of a material to decompose upon contact with tissue and / or body fluid and to be absorbed into tissue and / or body fluid. Some absorbable materials are known in the art and any suitable absorbable material can be used. Examples of suitable types of absorbable materials include absorbable homopolymers, copolymers or blends of absorbable polymers. Specific examples of suitable absorbable materials are poly-alpha hydroxy acids such as polylactic acid, polylactide, polyglycolic acid (PGA) or polyglycolide, trimethylene carbonate, polycaprolactone, polyhydroxybutyrate or polyhydroxyvalerate. Poly-beta hydroxy acids or polyphosphazenes such as, polyorganophosphazene, polyanhydrides, polyesteramides, polyorthostel, polyethylene oxides, polyester-ethers (eg, polydioxanone) or polyamino acids (eg, poly-L). -Contains other polymers such as glutamate or poly-L-lysine). There are also some naturally occurring absorbable polymers that may be suitable, including modified polysaccharides such as cellulose, chitin and dextran as well as modified proteins such as fibrin and casein.

Stainless steel and nitinol are currently considered suitable materials for use within the frame of implantable medical devices, at least due to their biocompatibility, formability and well-characterized properties. Has been done. Also included are cold drawn cobalt chromium alloys such as ASTM F562 and ASTM F1058 (commercial examples thereof include MP35N ™ and Elguiloy ™), both obtained from Fort Wayne Metals, Fort Wayne, IN. It is possible, MP35N is a registered trademark of SPS Technologies, Inc. (Jenkintown, PA, USA), and Elgily is a registered trademark of Chicago LLC (Elk Grove Village, IL, USA), which is also a registered trademark of Currently. In, considered to be suitable materials for frames, because at least these provide useful magnetic resonance imaging (MRI) compatibility and with some other materials such as stainless steel. This is because it is a non-magnetic material that normally avoids associated MRI artifacts.

The frame can be manufactured by any suitable method and technique, and the choice of the appropriate method and / or technique for manufacturing the frame includes various considerations including the properties of the material from which the frame is manufactured. It can be based on the matter. Examples of suitable techniques are frames from tubular sections of the appropriate material, such as by wrapping the appropriate wire around the appropriate mandrel, steps to form the frame from the wire, laser cutting the support frame from the metal tubular member, etc. The desired structure in the sheet shape is formed by cutting steps and vapor deposition or other suitable techniques, the sheet is formed into a tubular shape by rolling or other techniques, and by laser welding or other suitable techniques. Includes steps to secure the frame in a tubular shape.

If the implantable medical device includes a frame and a material mounted on the frame, the material mounted on the frame is capable of forming any suitable structure and is mounted on the frame to form. The choice of the appropriate structure for the material can be based on various considerations, including the treatment intended to be performed. Any suitable material can be attached to the frame to form an implantable medical device, and the selection of the appropriate material to be used with the frame within the implantable medical device is embedded. It can be based on various considerations, including the intended use and desired function of the implantable medical device. For valve devices such as venous valves, heart valves or any other valve device, one or more leaflets, each with a free edge, can be mounted on the frame, with the leaflets along the individual mounting pathways. Can include sections of material such as seats that are mounted on the frame. The leaflets can be formed from any suitable material and need only be biocompatible or biocompatible. The material can be formed from a bendable material. Examples of suitable materials used as leaflets in implantable medical devices include natural materials, synthetic materials and combinations of natural and synthetic materials. Examples of suitable natural materials include extracellular matrix (ECM) such as small intestinal submucosa (SIS) and other bioreconstructable materials such as bovine pericardium. Other examples of suitable ECM materials that may be used include gastric submucosal tissue, liver basement membrane, bladder submucosal tissue, tissue mucosa and dura mater. Other examples of suitable natural materials are parenchyma such as kidney fascia, abdominal fascia, abdominal parenchyma, connecting tissue, lung or lung ligament, tissue laminate and natural valve lobules with or without adjacent vessel wall. including. The pleura, including the visceral pleura, is also considered a suitable natural material. Fixed tissue, including fixed SIS, fixed pericardium, fixed lung or pulmonary ligaments and any other suitable fixed natural tissue, is also considered appropriate. When a fixed structure is used, any suitable fixing technique and / or procedure comprising aldehydes such as formaldehyde, glutaraldehyde and formalin and chemical fixing agents such as carbodiimides such as ethyldimethylaminopropylcarbodiimide, dicyclohexylcarbodiimide and the like. Can be used. Physical fixation techniques and / or procedures involving exposure to heat and / or radiation can also be used. Also, lyophilized and chemically dried preparations of these natural materials are considered appropriate. Examples of suitable synthetic materials include polymeric materials such as expanded polytetrafluoroethylene, polyurethane, polyurethane wear, polycarbonate and polyester.

Any material mounted on the frame can have the appropriate size, shape and composition. For example, the valve device can include one, two or more leaflets, which are sheet-like sections of material mounted on the frame. Another example of a material that can be mounted on a frame is a tubular structure that is mounted around the perimeter of the frame. In fact, a tubular structure and one, two or more leaflets can be attached to the frame to form a valve device with an outer sleeve.

Any material and / or element mounted on the frame can be mounted on the frame by any suitable method and with any suitable structure and / or material. For example, the leaflets can be sutured, tissue welded, one or more adhesives, one or more mechanical attachments, a combination of these methods and any other suitable structure and / or material. It can be mounted on the frame within the valve device.

The loading device 810 reduces the complexity of disinfection, storage, rinsing and / or loading of implantable medical devices and risks associated with the handling of implantable medical devices intended for implantation. It provides a mechanism for minimization. For example, the loading device 810 disinfects implantable medical devices by using a closure system that reduces interaction with implantable medical devices during disinfection, storage, rinsing and / or loading. Provides a mechanism for storage, rinsing and / or loading.

27 and 28 show an exemplary supply system 1210. The supply system 1210 includes a sheath 1212, an elongated member 1214, and a tip 1216.

The sheath 1212 extends through the first end 1220, the second end 1222, the length 1223, and the total length 1223, and comprises a portion of the elongated member 1214, a portion of the tip 1216, and a portion of the implantable device. Includes a body 1224 that defines a lumen 1226 sized and configured to accept. The second end of the sheath may optionally include a radiation opaque material. The elongated member 1214 has a longitudinal axis 1229, a first end 1230, a second end 1232, and a body 1234 defining an outer surface 1236, an inner surface 1238, a cavity 1240, and a notch 1242. In the illustrated embodiment, the elongated member 1214 is made of 304 stainless steel. The lumen 1240 extends through the entire length of the elongated member 1214 and is sized (eg, 0.035 ″) and configured to accommodate a portion of the wire guide or another medical device. The notch 1242 extends from the outer surface 1236 to the inner surface 1238 within the body 1234 of the elongated member 1214 towards the longitudinal axis 1229 and towards the second end 1232 of the elongated member 1214 at an angle 1243. In the illustrated embodiment, the angle 1243 is greater than zero degrees with respect to the longitudinal axis 1229 of the elongated member 1214. The notch is defined at any suitable angle, such as an angle equal to, less than, greater than or equal to 15 degrees, 30 degrees, 45 degrees, 60 degrees or 75 degrees with respect to the longitudinal axis of the elongated member. be able to. The notch 1242 is sized and configured to accept and bind a portion of the loading puller, as further detailed herein. In the illustrated embodiment, the angle 1243 is equal to about 45 degrees with respect to the longitudinal axis 1229 of the elongated member 1214. The elongated member 1214 is shown as defining an inner surface 1238 and a lumen 1240, but an alternative embodiment comprises an elongated member having a solid piece of material that does not include an inner surface defining the lumen. obtain. In this alternative embodiment, as described above for the elongated member 1214, the notch can be defined within the body as an elongated member.

The tip 1216 is disposed on the second end 1232 of the elongated member 1214 and has a first end 1246, a second end 1248, a cavity 1251, a first part 1252, a second part 1254 and a third. It has a body 1250 that defines a portion 1256. The tip 1216 is partially disposed within the sheath 1212 and is sized and configured to accept the implantable medical device above it so that the implantable medical device can be fed to the point of treatment. Has been done. In the illustrated embodiment, the first portion 1252 is sized and configured to be disposed within the sheath 1212. In one alternative embodiment, the elongated member can be disposed through a lumen defined by the tip such that the tip is disposed on a portion of the length of the elongated member. The notch 1242 may be open to implantable medical devices in which the loading puller may be disposed within the notch and may be disposed between the notch 1242 and the tip 1216 or disposed on the tip 1216. It is positioned at a distance of 1257, which is greater than the length of the loading puller, from the first end 1246 of the tip 1216 so that it can be mounted on. Although the tip 1216 is shown as defining the lumen 1251, one alternative embodiment may include a tip containing a solid piece of material with the lumen omitted.

FIG. 29 shows another exemplary supply system 1310. The supply system 1310 is similar to the supply system 1210 shown in FIGS. 27 and 28 and described above, except as detailed below. The supply system 1310 includes a sheath 1312, an elongated member 1314, a tip 1316, and a gripping member 1360.

In the illustrated embodiment, the elongated member 1314 has a longitudinal axis 1329, a first end 1330, a second end 1332, and a body 1334 defining the outer surface 1336. The grip member 1360 is mounted on the elongated member 1314 between the first end 1330 of the elongated member 1314 and the first end 1346 of the tip 1316. The grip member 1360 has a first end 1362, a second end 1364, a length 1365, and a body 1366. In use, the grip member 1360 is sized to be disposed within the lumen 1326 defined by the sheath 1312 and within the lumen defined by the implantable medical device disposed within the storage member. It is set and configured. The grip member 1360 provides a frictional force between the frame of the implantable medical device and the sheath 1312 and prevents the implantable medical device from jumping when released from the sheath 1312. It supports the controlled release of implantable medical devices at the time of supply. In embodiments where the balloon is included on the feeding system, the balloon can be positioned between the tip and the grip member, or can be considered a tip, and is positioned distal to the grip member. can do. In these embodiments, the elongated member is fluid communicating with the balloon chamber and can define an inflatable lumen extending to an inflatable port defined distal to the sheath.

The grip member can be formed from any suitable material and can have any suitable structural configuration, and the choice of suitable material and structural configuration for the grip member is , The grip member may be based on various considerations including the intended use of the supply system including the gripping member. Examples of materials that are considered appropriate for the grip member are any material, polymer, silicone, polyurethane, rubber and certain implementations that have a coefficient of friction greater than the coefficient of friction of the material forming the elongated member to which the grip member is mounted. Includes any other material deemed appropriate for morphology.

FIG. 30 shows another exemplary supply system 1410. The supply system 1410 is similar to the supply system 1210 shown in FIGS. 27 and 28 and described above, except as detailed below. The supply system 1410 includes a sheath 1412, an elongated member 1414, a tip 1416, and a gripping member 1460.

In the illustrated embodiment, the supply system comprises a grip member 1460 mounted on an elongated member 1414 between the notch 1442 and the first end 1446 of the tip 1416. The grip member 1460 has a first end 1462, a second end 1464, a length 1465, and a body 1466. In use, the grip member 1460 is sized to be disposed within the lumen 1426 defined by the sheath 1412 and within the lumen defined by the implantable medical device disposed within the storage member. It is set and configured. In the illustrated example, the grip member 1460 is positioned from the notch 1442 to a distance greater than the length of the loading puller intended to be used with the supply system 1410 (eg, length 661, length 2761). There is. Optionally, the supply system can include an inner pusher catheter disposed within the sheath and on an elongated member that can be used to assist in the supply of implantable medical devices. In addition, the supply system can include one or more calfs located between the notch and the near end of the elongated member.

31 and 32 show an alternative tip 1516 that can be disposed at the second end of an elongated member of an exemplary supply system. Tip 1516 is similar to Tip 1216 shown in FIG. 27 and described above, except as detailed below.

In the illustrated embodiment, the body 1550 of the tip 1516 defines the delimiter 1570 and the flat surface 1572. The shoulder 1570 is disposed between the first end 1546 of the tip 1516 and the second end 1548 of the tip 1516. The flat surface 1572 extends from the shoulder 1570 towards the second end 1548 to a location between the shoulder 1570 and the second end 1548. The inclusion of the shoulder 1570 and the flat surface 1572 is the tip 1516 and relative to other components such as those described herein (eg, loading member, storage member, device guard, flat surface of device guard). Provides a mechanism for orienting a mounted elongated member.

32A and 32B show alternative tips 1516'that can be disposed at the second end of an elongated member of an exemplary supply system. Tip 1516'is similar to Tip 1216 shown in FIG. 27 and described above, except as detailed below.

In the illustrated embodiment, the body 1550'of the tip 1516' defines the first recess 1570' and the second recess 1572'. Each of the first recess 1570'and the second recess 1572' extends from the first end 1546'to the second end 1548', and the tip 1516'and the attached elongated member are described herein. To accept a portion of a device guard or cap so that it can be oriented with respect to another component such as that described in (eg, loading member, storage member, device guard, flat surface of device guard). It is sized and configured. In the illustrated embodiment, each of the first recess 1570'and the second recess 1572' is disposed on a plane extending through the longitudinal axis of the tip 1516'. However, in the alternative embodiment, the first concave portion disposed on the first plane extending through the longitudinal axis of the tip and the tip at an arbitrary appropriate angle (for example, 45 degrees) with respect to the first plane. It can include a second recess disposed on a second plane extending through a longitudinal axis.

Although the first recess 1570'and the second recess 1572' are shown, the body of the tip is any suitable number of recesses to assist in orientation of the tip with respect to a portion of the storage and / or loading device. The choice of the appropriate number of recesses for the body of the tip to be defined can be based on various considerations such as the type of material forming the tip. Examples of the appropriate number of recesses for the body of the tip to be defined are one, two, plural, three, four, five, five or more and any deemed appropriate for a particular embodiment. Includes other numbers.

32C and 32D show an alternative first cap 114'that can be releasably attached to a storage member of an exemplary storage device or a loading member of an exemplary loading device. The first cap 114'is similar to the first cap 114 shown in FIGS. 4 and 5 and described above, except as detailed below.

In the illustrated embodiment, the first cap 114'includes a device guard 146' that can be releasably attached to the first end of the storage member or loading member. The device guard 146'has a longitudinal axis 147', a first end 148', a second end 150', a base 154', a first protrusion 156', a recess 160', a first protrusion 161'and a first. It has a main body 152'which defines two protrusions 163'. The base 154'extends from the first end 148'to the second end 150' and is sized and configured to be releasably mounted within the passageway of the storage member. In the illustrated embodiment, the base 154'has an outer diameter of 155', a first side portion 162', a second side portion 164', and a snap fit between the device guard 146'and the storage member. By using mounting, it is sized and configured to be releasably mounted on the storage member within the passageway.

The first protrusion 156'extends from the second side portion 164' to the second end portion 150'. The first protrusion 156'has an outer diameter 157' tapered between the base 154'and the second end 150'. The recess 160'extends from the first end 148'to the second end 150'to the recess base 166' and, as further detailed herein, is a portion of the supply system (eg, eg). , Tip 1516'), sized and configured to accept. The recess 160'has a first portion 168'and a second portion 170'. The first portion 168'has an inner diameter 167' that is constant from the first end portion 148'to the second portion 170'. The second portion 170'has an inner diameter of 169'that is tapered from the first portion 168'to the recess base 166'. The first portion 168'has a cylindrical configuration and the second portion 170'has a conical configuration. Each of the first protrusion 161'and the second protrusion 163' extends into the recess 160', and when the protrusions 161'and 163' are disposed in the recess defined by the tip of the supply system. The supply system is disposed so as to be rotationally secured to the device guard 146'so that it is coupled to the tip and in a recess defined by the tip (eg, recess 1570', recess 1572'). The size is set and configured so as to.

Although the first protrusion 161'and the second protrusion 163' are shown, the body of the device guard is any suitable number of protrusions to assist in tip orientation with respect to a portion of the storage device and / or loading device. The choice of the appropriate number of protrusions for the body of the device guard to be defined can be based on various considerations such as the type of material forming the tip. .. Examples of the appropriate number of protrusions for the body of the device guard to be defined are considered appropriate for one, two, plural, three, four, five, five or more and specific embodiments. Includes any other number.

33, 34, 35 and 36 show an exemplary guide system 1610. The guide system 1610 includes a guide board 1612, a loading member 1614, and a guide member 1616. The loading member 1614 is similar to the loading member 712 shown in FIG. 17 and described above, except as detailed below. The guide system 1610 can be used with any suitable storage device described herein, such as storage device 10, storage device 110, storage device 210, storage device 310 and / or storage device 510.

The guideboard 1612 includes a first end 1620, a second end 1622, a first side 1624, a second side 1626, an upper surface 1628, a lower surface 1630, a notch 1634 and a plurality of apertures. It has a body 1632 that defines 1636. The notch 1634 extends from the first end 1620 to the second end 1622 and, as described herein, includes a loading member 1614, a guide member 1616 and a storage member or an attached device guard. It is sized and configured to accommodate the including storage components. The first set 1638 of the apertures of the plurality of apertures 1636 is disposed in the vicinity of the first end 1620, and the second set 1640 of the apertures of the plurality of apertures 1636 is the first set 1638 and the first set of apertures. It is disposed between the two ends 1622.

In the illustrated embodiment, the loading member 1614 is disposed within the notch 1634 and is releasably mountable to the guideboard 1612 using mounting pins (not shown). The loading member 1614 has a first portion 1615 that is releasably mounted to the second portion 1617 using a mounting pin. Alternatively, the first and second parts of the loading member can be positioned in a mutual relationship and can not be mounted releasably from each other. The loading member 1614 includes a longitudinal axis 1644, a first end 1646, a second end 1648, a first opening 1652, a second opening 1654, a passageway 1656, a first track 1658, a second track 1660, It has a third track 1662, a fourth track 1677, a plurality of mounting passageways 1663 and a body 1650 defining guide pins 1665. The first opening 1652, the second opening 1654, the passageway 1656, the first track 1658, the second track 1660 and the plurality of mounting passageways 1663 are co-defined by the first and second portions 1615, 1617, respectively. ing. The passageway 1656 extends from the first opening 1652 to the second opening 1654 and includes a first portion 1664, a second portion 1666, a third portion 1668, a fourth portion 1670, and a fifth portion 1672. Has. The passageway 1656 is sized and configured to accommodate a portion of implantable medical devices, loading pullers and supply systems such as those described herein. The first portion 1664 extends from the first end portion 1646 to the second portion and has a constant inner diameter. However, alternative embodiments may omit inclusion of the first part (eg, first part 1664). The second portion 1666 has an inner diameter of 1667 extending from the first portion 1664 to the third portion 1668 and tapered from the first portion 1664 to the third portion 1668. The third portion 1668 extends from the second portion 1666 to the fifth portion 1672 and has an inner diameter 1669 that is smaller than the inner diameter 1667 of the first portion 1664 at the first end 1646. The third portion 1668 is sized and configured to accommodate a portion of the implantable medical device, a loading puller and a portion of the feeding system (eg, gripping member). The fourth portion 1670 extends from the third portion 1668 to the second end 1648 and has a width 1671 greater than the inner diameter 1669 of the third portion 1668. Fourth portion 1670 is sized and configured to accept a portion of the loading puller in an open or partially open configuration, as further detailed herein. The fifth portion 1672 extends from the third portion 1668 (eg, the location between the second end 1648 and the third end 1668) to the second end 1648 and is smaller than the width 1671 of the fourth portion 1670. And has an inner diameter 1673 that is larger than the inner diameter 1669 of the third portion 1668. The fifth portion 1672 is sized and configured to accommodate a portion of the sheath of the supply system, as further detailed herein. The reduction in diameter between the fifth portion 1672 and the third portion 1668 has produced a shoulder 1674 that acts as a mechanical stop for the advancement of the sheath of the supply system through the passageway 1656. In the illustrated embodiment, the third portion 1668 has a first cross-sectional configuration (eg, a circular cross-sectional configuration) acquired along a plane orthogonal to the longitudinal axis 1644, and the fourth portion 1670 is a third portion. A second cross-sectional configuration obtained along a plane extending from 1668 (eg, the location between the second end 1648 and the second end 1666) to the second end 1648 and orthogonal to the longitudinal axis 1644. (Eg, an elongated cross-section configuration, a rectangular cross-section configuration), and the fifth portion 1672 has a third cross-section configuration (eg, circular cross-section configuration) acquired along a plane orthogonal to the longitudinal axis 1644. .. In the illustrated embodiment, the first and third cross-sectional configurations are identical and circular, and the second cross-sectional configuration is different from the first and third cross-sectional configurations and is elongated.

In use, when the loading puller is pulled through the passageway 1656, the loading puller is compressed as it moves through the second portion 1666 of the passageway 1656 and then expands when it reaches the fourth portion 1670 of the passageway 1656. do.

Each of the first track 1658 and the third track 1662 is disposed on a plane including the longitudinal axis 1644 of the loading member, extends into the body 1650 to the base 1651, and has a first end 1646 to a fourth portion. It extends to 1670. However, in the alternative embodiment, each of the first and second tracks is arranged on a plane that does not include or contacts the longitudinal axis of the loading member, or one of the first and second tracks. The first track and the second track can be defined such that only one is disposed on a plane that includes or contacts the longitudinal axis of the loading member. Each of the first track 1658 and the third track 1662 has a thickness measured at a location orthogonal to the longitudinal axis 1644 when the first and second portions 1615, 1617 of the loading member 1614 are mounted to each other. Have. The distance between the base 1651 of the first track 1658 and the base 1651 of the third track 1662 along the first portion 1664 of the passageway 1656 is greater than the inner diameter of the first portion 1664. The distance between the base 1651 of the first track 1658 and the base 1651 of the third track 1662 along the second portion 1666 of the passageway 1656 is greater than the inner diameter 1667 of the second portion 1666. The distance between the base 1651 of the first track 1658 and the base 1651 of the third track 1662 along the third portion 1668 of the passageway 1656 is greater than the inner diameter 1669 of the third portion 1668 and the width of the fourth portion 1670 1674. Smaller. Each of the second track 1660 and the fourth track 1677 extends from the first end 1646 to the fifth portion 1672. In the alternative embodiment, the second track and the fourth track can be omitted from the loading member. Each of the first track 1658 and the third track 1662 is sized and configured to accommodate a portion of the loading puller and provides a mechanism for guiding the loading puller through the loading member 1614 in use. Each of Track 2 1660 and Track 4 1677 is sized and configured to accommodate a portion of implantable medical device. For example, in embodiments, the implantable medical device comprises a frame having a portion (eg, one or more markers, one or more barbs) extending outward from the longitudinal axis of the frame. One or each of the two tracks and the fourth track provides a mechanism for guiding an implantable medical device through the loading member 1614 in use.

Each of the multiple mounting passageways 1663 has one or more alignment pins (not shown) positioned within the passageway and aperture to maintain the position of the loading member 1614 with respect to the guideboard 1612. It is sized and configured to align with the second set 1640 of the aperture of the guideboard 1612 so that it may be. Each of the guide pins 1665 extends away from the first end 1646 of the first portion 1615 of the loading member 1614 away from the second end 1648 and provides alignment between the storage member and the loading member 1614. To be accepted by a passageway defined by a storage member (eg, passageway 280, passageway 282).

The guide member 1616 is disposed within the notch 1634 and is releasably mountable to the guideboard 1612 using mounting pins (not shown). The guide member 1616 has a first portion 1619 that is releasably mounted to the second portion 1621 using a mounting pin. The guide member 1616 is a body 1680 defining a longitudinal axis 1675, a first end 1676, a second end 1678, a first opening 1682, a second opening 1684, a passageway 1686 and a plurality of mounting passageways 1688. And have. The first opening 1682, the second opening 1684, the passageway 1686 and the plurality of mounting passageways 1688 are co-defined by the first and second portions 1619, 1621, respectively. The passageway 1686 extends from the first opening 1682 to the second opening 1684 and is sized and configured to accommodate a portion (eg, sheath) of the supply system, such as that described herein. ing. Guide member 1616 provides a mechanism for maintaining the position of the supply system while loading implantable medical devices, as further detailed herein. Each passageway of the plurality of mounting passageways 1688 has one or more mounting pins (not shown) positioned within the passageway and aperture to maintain the position of the guide member 1616 with respect to the guideboard 1612. It is sized and configured to align with the first set 1638 of the aperture of the guideboard 1612 so that it may be. Although the guideboard 1612, loading member 1614 and guide member 1616 are shown as separate elements, the guideboard can be an integrated component with loading and / or guide members. For example, the guide member can be permanently mounted on the guide board.

FIG. 37 shows a storage device 1712 according to an embodiment, a device guard 1714 according to an embodiment, a supply system 1716 according to an embodiment, a guide system 1718 according to an embodiment, an instruction 1720 for use, and a storage container. An exemplary kit 1710 comprising 1722 and is shown.

Any suitable storage device, device guard, supply system, loading member, loading assister, loading puller and guide system can be included in the kit and the appropriate storage device, device guard, supply included in the kit. The choice of system, loading member, loading assister, loading puller and guide system is based on various considerations, including the type of implantable medical device intended to be implanted using the kit. Can be. Examples of storage devices that are considered appropriate for inclusion in the kit are storage device 10, storage device 110, storage device 210, storage device 310, storage device 510, variants of the storage device described herein. Includes any other storage device according to embodiments and embodiments. Examples of device guards deemed appropriate for inclusion in the kit are device guard 146, device guard 715, device guard 1714, device guard 2615, variants and embodiments of the device guard described herein. Includes any other device guard by. Examples of supply systems that are considered appropriate for inclusion in the kit are supply system 1210, supply system 1310, supply system 1410, supply system 2510, variants and embodiments of the supply system described herein. Includes any other supply system by. Examples of loading members deemed appropriate for inclusion in the kit include loading member 712, loading member 1012, loading member 1614, loading member 2814, variants and embodiments of the loading member described herein. Includes any other loading member by. Examples of loading assisters that are considered appropriate for inclusion in the kit include the loading assister 2710 and any other loading assisters that are considered appropriate for a particular embodiment. Examples of loading pullers deemed appropriate for inclusion in the kit include loading puller 652, loading puller 2752 and any other loading puller deemed appropriate for a particular embodiment. Examples of guide systems deemed appropriate for inclusion in the kit include guide system 1610, variants of the guide system described herein and any other guide system according to one embodiment. In the illustrated embodiment, the kit 1710 is shown in the storage device 510 shown in FIGS. 15, 16 and 16A, the supply system 1410 shown in FIG. 30, and in FIGS. 33, 34, 35 and 36. Includes the indicated guide system 1610.

In the illustrated embodiment, the device guard 1714 is similar to the device guard 715 shown in FIG. 17 and described above, except as detailed below. The device guard 1714 can be releasably attached to the first end 520 of the storage member 512, and the body 1760 of the device guard 1714 has a base 1762, a side wall 1764, a protrusion 1766, and a first opening 1768. , The second opening 1770 and the passageway 1772 are defined. The base 1762 and side walls 1764 co-define a cavity 1770 sized and configured to accommodate a portion of the storage member 512. The protrusion 1766 extends from the base 1762 through the cavity 1770 to the environment outside the cavity 1770. The passageway 1772 extends from the first opening 1768 to the second opening 1770 and is sized and configured to accommodate a portion of the supply system, as detailed herein.

Kit 1710 is shown as including a single storage device 510, a single device guard 1714, a single supply system 1310 and a single guide system 1610, but is described herein. Any suitable number and type of storage device, device guard, supply system, loading member, loading puller, loading assister and / or guide system can be included in the kit. A selection of the appropriate number of storage devices, device guards, supply systems, loading components, loading pullers, loading assisters and / or guide systems included in the kit according to one particular embodiment shall be implanted using the kit. It can be based on various considerations such as the type of implantable medical device intended. An appropriate number of examples of storage devices, device guards, supply systems, loading components, loading pullers, loading assisters and / or guide systems included in the kit are at least one, one, two, plural, three. Includes four and any other number deemed appropriate for a particular embodiment.

The kit 1710 is shown to include only the storage device 1712, device guard 1714, supply system 1716, guide system 1718, instructions for use 1720 and storage container 1720, although the kit is of any suitable number. Can include optional components. (Eg, loading, pre-mounted on a loading puller, pre-mounted on a loading puller and placed in a container, provided without a storage device, disposed within a storage device. An example of the number of optional components considered appropriate for inclusion in the kit, such as implantable medical devices (pre-mounted on the puller and disposed within the loading member), is one. Includes at least one, two, plural, three, four, five, more than five and any other number deemed appropriate for a particular embodiment. Examples of optional components and / or devices deemed appropriate for inclusion in the kit are containers or bags (eg IV) filled with saline, lubricants, rinse solutions or wash solutions. Includes bags), tubes, balls, guide wires, catheters, syringes and / or any other component and / or device deemed appropriate for a particular embodiment.

The storage container included in the kit can have any suitable structural configuration and can be formed from any suitable material and is suitable structure for forming the storage container. The choice of configuration and materials may be based on various considerations including the number of storage devices, device guards, supply systems, loading components and / or guide systems included in the kit. Examples of structural configurations that are considered appropriate for forming storage containers are boxes, boxes with lids, boxes with lids mounted on boxes (eg, rotatably mounted), bags and Includes any other structural configuration deemed appropriate for a particular embodiment. Examples of materials that are considered appropriate for forming storage containers are metals, plastics, glass, combinations of materials described herein and any other that is considered appropriate for a particular embodiment. Including materials. In the illustrated embodiment, the storage container 1722 is a box 1723 made of rigid plastic.

FIG. 38 is an exemplary kit 1810 comprising a loading device 1812 according to one embodiment, a device guard 1814 according to one embodiment, a supply system 1816 according to one embodiment, instructions 1818 for use, and a storage container 1820. Is shown.

Any suitable loading device, device guard and supply system can be included in the kit, and the selection of the appropriate loading device, device guard and supply system included in the kit is implanted using the kit. It can be based on various considerations, including the type of implantable medical device intended to be. Examples of loading devices deemed appropriate to include in the kit include loading device 710, loading device 810, variants of the loading device described herein and any other loading device according to one embodiment. include. Examples of device guards deemed appropriate for inclusion in the kit are device guard 146, device guard 715, device guard 1714, device guard 2615, variants of the device guard described herein and one embodiment. Includes any other device guard by mode. Examples of supply systems that are considered appropriate for inclusion in the kit are supply system 1210, supply system 1310, supply system 1410, supply system 2510, variants and embodiments of the supply system described herein. Includes any other supply system by mode. In the illustrated embodiment, the kit 1810 is shown in FIGS. 18, 19, 20, 21, 21, 22, 23, 24, 25 and 26 with the loading device 810 shown in FIG. Includes the supply system 1410 and the like.

Kit 1810 is shown to include a single loading device 1812, a single device guard 1814 and a single supply system 1816, but any suitable number, such as those described herein. And types of loading devices, device guards and / and supply systems can be included in the kit. A selection of the appropriate number of loading devices, device guards and / or supply systems included within the kit according to a particular embodiment of the implantable medical device intended to be implanted using the kit. It can be based on various considerations such as type. An appropriate number of examples of loading devices, device guards and / or supply systems included in the kit are considered appropriate for at least one, one, two, plural, three, four and specific embodiments. Includes any other number.

The kit 1810 is shown to include only the loading device 1812, the device guard 1814, the supply system 1816, the instructions 1818 for use and the storage container 1820, but the kit is an arbitrary number of optional components. Can be included. (Eg, loading, pre-mounted on the loading puller, pre-mounted on the loading puller and placed in the container, provided without the loading device, disposed within the loading device. An example of the number of optional components considered appropriate for inclusion in the kit, such as implantable medical devices (pre-mounted on the puller and disposed within the loading member), is one. Includes at least one, two, plural, three, four, five, more than five and any other number deemed appropriate for a particular embodiment. Examples of optional components and / or devices deemed appropriate for inclusion in the kit are containers or bags filled with saline, lubricants, rinse solutions or wash solutions (eg IV). Includes bags), tubes, balls, guide wires, catheters, syringes and / or any other component and / or device deemed appropriate for a particular embodiment.

Storage members, caps, device guards, one-way valves, two-way valves, diffusers, loading members, loading pullers, loading assisters, connectors, catheters, elongated members, push members, tips, guides of embodiments described herein. Boards, guide members and any other device, component, element or feature can be formed from any suitable material and by using any suitable manufacturing method. The choice of suitable materials and manufacturing methods can be based on various considerations, including the intended use of equipment, components, elements or features. Storage members, caps, device guards, one-way valves, two-way valves, diffusers, loading members, loading pullers, loading assisters, connectors, catheters, elongated members, push members, tips, guides of embodiments described herein. Examples of materials that are considered suitable for forming boards, guide members and any other device, component, element or feature are biocompatible materials, materials that may have biocompatibility, metals, plastics, etc. Includes polymers, transparent materials, opaque materials and any other material deemed appropriate for a particular embodiment. Optionally, the storage member, cap, device guard, one-way valve, two-way valve, diffuser, loading member, loading puller, loading assister, connector, catheter, elongated member, push member of the embodiments described herein. , A tip, a guide board, a guide member and any other device, component, element or feature of the gasket (eg,) disposed between itself and another element to which it is mounted. , O-ring) can be included.

Storage members, caps, device guards, one-way valves, diffusers, loading members, loading pullers, loading assisters, connectors, catheters, elongated members, push members, tips, guideboards, guide members and others described herein. Any attachment between elements can utilize any suitable technique or method of attachment between elements. The choice of appropriate technique or method of attachment between the two elements can be based on various considerations, including one or more materials forming the element. Examples of mounting techniques and methods deemed appropriate between the two elements described herein are those shown, threaded connections, use of snap-fit mounting, and one or more connectors. Use, one or more coupling slots and protrusions, perforable membranes between elements, releasable attachments, permanent attachments and any other technique or method of attachment deemed appropriate for a particular application. including.

As used herein, various types of disinfecting implantable medical devices, storing implantable medical devices, rinsing implantable medical devices, and loading implantable medical devices onto supply systems. It describes how to do it. Although the methods described herein are illustrated and described as a series of actions, some actions are shown and / or described in different order and / in accordance with these methods. Or understand and recognize that the method is not limited by the order of the acts, as they can occur simultaneously with the other acts described herein.

FIG. 39 is a schematic representation of an exemplary method 1900 for disinfecting implantable medical devices.

Step 1902 includes inserting a implantable medical device into the storage member. Another step 1904 includes attaching the first cap to the storage member. Another step 1906 includes introducing the disinfectant material into the storage member. Another step 1908 includes introducing the retaining material into the storage member so that the disinfectant material is removed from the storage member. Another step 1910 includes attaching the second cap to the storage member.

Step 1902 can be accomplished by using any suitable implantable medical device, such as those described herein. In the illustrated embodiment, exemplary methods of disinfecting implantable medical devices 1900 include methods of disinfecting valve devices. Step 1902 is along the longitudinal axis of the storage member until the implantable medical device is disposed within a portion of the passageway defined by the storage member (eg, first and second parts). This can be achieved by applying an axial force towards the end of the storage member (eg, first end, second end) to the implantable medical device . Any other storage member, such as the storage member described herein, can be used to complete Method 1900. Optional steps that may be completed before or after step 1902 include the releasably mounting of the loading puller on an implantable medical device.

Step 1904 can be implemented using any suitable cap, such as the cap described herein, and the cap shall be attached to the first or second end of the storage member. Can be done. Alternatively, step 1904 may include mounting the loading member on the storage member and may be implemented using any suitable loading member, such as the loading member described herein. Can be done.

Step 1906 is by using any suitable method or technique for introducing disinfectant material into the storage member (eg, using a syringe) and within the passageway defined by the storage member (eg, the first of the passageway). Disinfectant material is applied to the first opening of the storage member or so that it accumulates in only two parts, only in the first part of the passageway, in both the first and second parts of the passageway) or through the passageway. It can be realized by passing it through the second opening. It is possible to introduce any suitable disinfectant material into the storage member, and the selection of the appropriate disinfectant material will take into account various considerations, including the type of implantable medical device disposed within the storage member. It can be based on the matter. Examples of disinfectant materials include glutaraldehyde, formaldehyde, alcohol and any other disinfectant material deemed appropriate for a particular embodiment. The optional step includes removing the disinfectant material from the storage member. By optional option, step 1906 can be realized before step 1904.

Step 1908 is by using any suitable method or technique for introducing the holding material into the storage member (eg, using a syringe) and within the passageway defined by the storage member (eg, the first of the passageways). To accumulate in only two parts, only in the first part of the passageway, in both the first and second parts of the passageway) or through the passageway and to replace any disinfectant material in the storage member. In addition, it can be realized by passing the holding material through the first opening or the second opening of the storage member. It is possible to introduce any suitable holding material into the storage member, and the selection of the appropriate holding material will take into account various considerations, including the type of implantable medical device disposed within the storage member. It can be based on the matter. Examples of retention materials are glutaaldehyde, saline, formal hide, phosphate buffer, phosphate buffered saline (PBS), agonists, biological agonists, coatings, absorbable coatings, drugs, etc. Includes quenching solutions, quenching solutions that may contain amino acids, anti-mineralization materials, rinse fluids, wash fluids and any other retention material deemed appropriate for a particular embodiment. Depending on the option, step 1908 can be completed multiple times (eg, two or three times). By optional option, step 1908 can be realized before step 1904 and after step 1906.

Step 1910 can be implemented using any suitable cap, such as the caps described herein, where the cap is the first or second end of the storage member without the cap. Can be attached to. In one alternative embodiment, step 1904 may include attaching a cap to the storage material, and step 1910 may include attaching the loading member to the storage member. FIG. 40 shows an implantable medical device 1912 stored within an exemplary storage member 1914.

Although various steps, alternative steps and optional steps have been described above for exemplary method 1900, these steps, alternative steps and optional steps are exemplified in Method 2000, Exemplary Method 2100. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2200, an exemplary method 2300, an exemplary method 2400 and / or an exemplary method 2900. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

FIG. 41 shows a schematic of another exemplary method 2000 for disinfecting implantable medical devices.

Step 2002 includes inserting a implantable medical device into the storage member. Another step 2004 includes attaching the first cap to the storage member. Another step 2006 includes attaching the second cap to the storage member. Another step 2008 includes introducing the disinfectant material into the storage member. Another step 2010 includes introducing the retaining material into the storage member so that the disinfectant material is removed from the storage member.

Step 2002 can be realized as described above for step 1902.

Step 2004 can be implemented using any suitable cap, such as the caps described herein, and the cap is attached to the first or second end of the storage member. Can be done. Alternatively, step 2004 may include mounting the loading member on the storage member and may be accomplished using any suitable loading member, such as the loading member described herein. Can be done.

Step 2006 can be implemented using any suitable cap, such as the caps described herein, where the cap is the first or second end of the storage member without the cap. Can be attached to.

In step 2008, the disinfectant material passes through the first or second opening of the storage member and is within the passageway defined by the storage member (eg, only within the second portion of the passageway, only within the first portion of the passageway). Achieve using any suitable method or technique of introducing disinfectant material into the storage component so that it accumulates (in both the first and second parts of the passageway) or passes through the passageway. Can be done. For example, a syringe or line connected to a bag containing the disinfectant material can be attached to the first one-sided valve, and the disinfectant material is contained within the storage member and does not pass through the second one-sided valve. As such, the disinfectant fluid can be used to introduce into the storage member. Instead, to allow the disinfectant fluid to pass through the second one-way valve and into the storage member, or through the first one-sided valve, the storage member and the second one-sided valve, or through the second one-sided valve, the storage member and the first one-sided valve. , A syringe or line connected to the bag can also be used. Any suitable disinfectant material can be introduced into storage components such as those described herein. Optional steps include removing the syringe or line from the one-way valve.

In step 2010, the holding material passes through the first or second opening of the storage member and is within the passageway defined by the storage member (eg, only within the second portion of the passageway, only within the first portion of the passageway). , Into both the first and second parts of the passageway) or through the passageway, using any suitable method or technique to introduce the retaining material into the storage member. be able to. For example, a syringe or line connected to a bag containing the holding material can be attached to the first one-way valve, and the holding material is housed in the storage member and does not pass through the second one-way valve. , Can be used to introduce the holding fluid into the storage member. Instead, to pass the holding fluid through the second one-way valve and into the storage member, or through the first one-sided valve, the storage member and the second one-sided valve, or through the second one-sided valve, the storage member and the first one-sided valve. A syringe or line attached to the bag can also be used. Optional steps include removing the syringe or line from the one-way valve. Any suitable holding material, such as those described herein, can be introduced into the storage member. Depending on the option, step 2010 can be completed multiple times (eg, two or three times). This can be completed over a specific period of time (eg, 1 minute, 5 minutes) each time step 2010 is completed and / or until a defined retention fluid volume passes through the storage member. FIG. 42 shows a implantable medical device 2012 stored in an exemplary storage member 2014, and first and second bends and first and first bends pre-mounted on the implantable medical device 2012. 2 Shows a loading puller 2016 that defines only the curvature between the bends.

Although various steps, alternative steps and optional steps have been described above for exemplary method 2000, these steps, alternative steps and optional steps are exemplified in Method 1900, Exemplary Method 2100. Within the methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2200, an exemplary method 2300, an exemplary method 2400 and / or an exemplary method 2900. It can be included in, and at the same time, it can be realized, and / or it can be realized as an alternative form thereof.

FIG. 43 is a schematic representation of an exemplary method 2100 for preserving implantable medical devices.

Step 2102 includes inserting a disinfected implantable medical device into the storage member. Another step 2104 includes attaching the first cap to the storage member. Another step 2106 includes introducing the holding material into the storage member. Another step 2108 includes attaching the second cap to the storage member.

Step 2102 can be implemented as described above for step 1902. Optional steps that may be completed prior to step 2102 include disinfecting the implantable medical device, rinsing the implantable medical device and / or attaching a loading puller to the implantable medical device. Including steps. These optional steps can be accomplished using conventional disinfection and / or rinsing methods or those described herein. In an alternative embodiment, step 2102 may include obtaining a disinfected implantable medical device disposed within a storage member.

Step 2104 can be implemented using any suitable cap, such as the caps described herein, and the cap is attached to the first or second end of the storage member. Can be done. Alternatively, step 2104 may include mounting the loading member on the storage member and may be accomplished using any suitable loading member, such as the loading member described herein. Can be done.

Step 2106 uses any suitable method or technique for introducing the holding member into the storage member (eg, using a syringe) and within the passageway defined by the storage member (eg, second of the passageway). Retaining material is placed in the first opening or first opening of the storage member so that it accumulates in or passes through the passageway, either within the portion only, within the first portion of the passageway only, within both the first and second portions of the passageway). It can be realized by passing it through two openings. Any suitable holding material, such as those described herein, can be introduced into the storage member. Depending on the option, step 2106 can be completed multiple times (eg, two or three times). By optional option, step 2106 can be realized before step 2104 or after step 2108. In an embodiment in which step 2106 is realized following step 2108, step 2106 is for the holding material to pass through a first or second opening of the storage member and in a passageway defined by the storage member (eg, for example. Introduce the retaining material into the storage member so that it accumulates or passes through the passageway (inside only the second part of the passageway, only in the first part of the passageway, in both the first and second parts of the passageway). It can be achieved using any suitable method or technique. For example, a syringe containing the holding material can be mounted in the first one valve, and the holding fluid is placed in the storage member so that the holding material is housed in the storage member and does not pass through the second one valve. Can be used to introduce to. Instead, to allow the holding fluid to pass through the second one-way valve and into the storage member, or through the first one-sided valve, the storage member and the second one-sided valve, or through the second one-sided valve, the storage valve and the first one-sided valve. You can use a syringe in the storage. In this embodiment, step 2106 can be completed multiple times (eg, two or three times). This can be completed over a specific period of time (eg, 1 minute, 5 minutes) each time step 2106 is completed and / or until a defined retention fluid volume passes through the storage member. Optional steps include removing the syringe or line from the one-way valve.

Step 2108 can be implemented using any suitable cap, such as the cap described herein, where the cap is the first or second end of the storage member without the cap. Can be attached to.

Although described above with respect to the exemplary method 2100 for various steps, alternative steps and optional steps, these steps, alternative steps and optional steps are exemplified in Method 1900, Exemplary Method 2000. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2200, an exemplary method 2300, an exemplary method 2400 and / or an exemplary method 2900. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

FIG. 44 is a schematic representation of an exemplary method 2200 for rinsing implantable medical devices.

Step 2202 includes mounting a device containing the rinse material on one valve of the storage device. Another step 2204 includes introducing the rinse material into the storage device so that it passes through the storage device. Another step 2206 includes stopping the step of introducing the rinse material into the storage device.

Step 2202 is a syringe, line and any other device deemed appropriate for a particular embodiment by using any suitable mounting method or technique and mounted on a bag containing a rinse material. This can be achieved by using any suitable device, including rinsing materials such as. It is possible to include any suitable rinsing material within the device, and the selection of the appropriate rinsing material will take into account various considerations, including the type of implantable medical device disposed within the storage member. It can be based on the matter. Examples of rinse-off materials are suitable for saline, agonists, biological agonists, coatings, absorbable coatings, agents, phosphate buffers, phosphate buffered saline (PBS) and certain embodiments. Includes any other rinse material that is considered to be. In the embodiments described, the device is mounted on the first one-way valve of the storage device. However, the alternative embodiment may include a device mounted on the second one-way valve or two-way valve of the storage device.

Although step 2202 is described as being completed by mounting the device on the storage device, alternative embodiments may include mounting the device on the loading device. In step 2202, the device is the first one-way valve of the storage device and / or the loading device, the first two-way valve of the storage device and / or the loading device, the second one-way valve of the storage device and / or the loading device, or the storage device and /. Alternatively, it can be realized by attaching it to the second two-way valve of the loading device.

In step 2204, the rinse material passes through the first or second opening of the storage member and is within the passageway defined by the storage member (eg, only within the second portion of the passageway, only the first portion of the passageway). Within, in both the first and second parts of the passageway) or through the passageway, using any suitable method or technique to introduce the rinse material into the storage device. Can be done. Instead, the rinse fluid is passed through the second one-way valve and into the storage member, or through the first one-sided valve, the storage member and the second one-sided valve, or through the second one-sided valve, the storage member and the first one-sided valve. A syringe can also be used for this. Alternatively, a syringe containing the rinse material can be attached to the first one-way valve, and the rinse fluid is contained within the storage member and does not pass through the second one-way valve. Can also be used to introduce into the storage component. Step 2204 can be completed multiple times (eg, two or three times). This can be completed over a specific period of time (eg, 1 minute, 5 minutes) each time step 2204 is completed and / or up to the point at which the specified rinse fluid volume passes through the storage member.

Optionally, steps 2202, 2204, 2206 can be repeated one or more times by using a second rinse fluid that is different from the rinse fluid initially passed through the storage member. The optional step includes rocking the storage member at or after the completion of step 2204.

Method 2200 has been described as being implemented using one-sided valves, but other embodiments may include storage devices and / or loading devices that omit the inclusion of one or more one-sided valves. In these embodiments, the method 2200 comprises a step of removing the first cap, a second cap, a first one-sided valve and / or a second one-sided valve, a step of immersing the storage member in the rinse material, optionally. A step of rocking the storage member and a step of removing the storage member from the rinse material can be included. In the method described herein, any inclusion of a one-way valve can be replaced with a two-way valve in an alternative embodiment.

Although described above with respect to the exemplary method 2200 for various steps, alternative steps and optional steps, these steps, alternative steps and optional steps are exemplified in Method 1900, Exemplary Method 2000. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2100, an exemplary method 2300, an exemplary method 2400 and / or an exemplary method 2900. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

FIG. 45 is a schematic representation of an exemplary method 2300 for loading an implantable medical device onto a supply system.

Step 2302 includes removing the first cap from the storage member accommodating the implantable medical device. Another step 2304 includes removing the diffuser from the storage member. Another step 2306 includes attaching the device guard to the storage member. Another step 2308 includes removing the second cap from the storage member. Another step 2310 includes attaching the storage member to the loading member of the guide system. Another step 2312 includes applying an axial force towards the storage member to a portion of the supply system such that it passes through the storage member, the loading member, and is partially disposed within the device guard. .. Another step 2314 comprises positioning the loading puller within a notch defined by an elongated member of the supply system. Another step 2316 is an axial force towards the elongated member of the supply system away from the storage member until the first and second ends of the loading puller are disposed within the fourth portion of the loading member. Includes the step of applying. Another step 2318 includes removing the loading puller from the supply system and loading members. Another step 2320 comprises applying an axial force towards the loading member to the sheath of the supply system while maintaining the position of the elongated member until the sheath contacts the loading member. Another step 2322 is an axial force on the elongated member towards the elongated member away from the storage member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Includes the step of applying. Another step 2324 includes removing the supply system from the loading member.

Step 2302 can be realized by applying a force (for example, an axial force, a rotational force) toward the first cap so as to remove the cap from the storage member . The type of force will depend on the type of attachment between the cap and the storage member.

Step 2304 can be realized by any suitable method such as applying a force toward the diffuser away from the storage member in the embodiment in which the diffuser is disposed so as to be releasable in the storage member. Alternatively, in embodiments where the diffuser is permanently or releasably attached to the cap, step 2304 can be realized at the same time as step 2302.

Step 2306 can be realized by applying a force toward the storage member to the device guard until the time when the device guard is attached to the storage member. Step 2306 can be implemented using any suitable device guard, such as the device guard described herein. In one alternative embodiment, step 2306 can be omitted from the method of loading implantable medical devices onto the supply system.

Step 2308 can be realized by applying a force (eg, axial force, rotational force) toward the second cap away from the storage member so that the cap is removed from the storage member. The type of force will depend on the type of attachment between the cap and the storage member.

Step 2310 applies a force toward the loading member to the storage member until the storage member is mounted on the loading member, or directs the storage member toward the storage member until the storage member is mounted on the loading member. This is achieved by applying a force or applying a force toward the loading member to the storage member and applying a force toward the storage member to the loading member until the time when the storage member is mounted on the loading member. be able to. 46 and 46A show the storage member 2330 mounted on the loading member 2332 of the guide system 2334.

Step 2312 can be implemented using any suitable supply system, such as the supply system described herein. Step 2312 maintains the position of the sheath and the loading member onto the elongated member until the elongated member passes through the storage member, the loading member and is partially (eg, tipped) disposed within the device guard. It can be realized by applying an axial force toward .

Step 2314 can be realized by applying a force towards the elongated member of the supply system to the loading puller until the loading puller is disposed in the notch defined by the elongated member. 47 and 47A show a supply system 2336 partially disposed within the device guard 2338 and a loading puller 2340 disposed within a notch 2342 defined by an elongated member 2344. 48 and 48A show a loading puller 2340 that is free from implantable medical devices in an open state and is disposed within a fourth portion of the loading member. As further detailed herein, in embodiments where the loading puller 2752 is utilized, another step is initially longitudinal direction of the loading puller 2752 with respect to each of the first and second parts. A step of applying an axial force directed away from the longitudinal axis 2757 to move the loading puller into the open configuration after being directed to the axis 2757 and the first and second portions have passed the longitudinal axis 2757. including.

Step 2318 can be realized by applying an axial force away from the supply system to the loading puller until it is free from the supply system. 49 and 49A show a sheath advancing towards the loading puller to contact the loading member (eg, it is in contact with the delimiter 1674 defined within the delimitation way defined by the loading member. , It is in contact with the second end of the loading member).

Step 2322 optionally provides a releasable fit between the loading member and the sheath so that the position of the sheath can be maintained while the elongated member retracts into the sheath. This can be achieved by using a structure that is attached to or separate from the member. For example, the loading member is sized and configured to bond to the sheath and maintain the position of the sheath until an axial force is applied to the sheath to remove it from the loading member. Can include collets or bendable flaps that extend within the passageway defined by.

Step 2324 can be realized by applying an axial force to the supply system towards a point away from the loading member until the supply system is free from the loading member. The optional step involves implanting a implantable medical device within the patient's body. Another optional step involves orienting the tip of the supply system to implantable medical devices using device guards.

Although various steps, alternative steps and optional steps have been described for exemplary method 2300, these steps, alternative steps and optional steps are described in exemplary method 1900, exemplary method 2000. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2100, an exemplary method 2200, an exemplary method 2400 and / or an exemplary method 2900. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

FIG. 50 is a schematic representation of another exemplary method 2400 for loading implantable medical devices onto a supply system.

Step 2402 includes removing the cap from the storage member accommodating the implantable medical device. Another step 2404 includes removing the diffuser from the storage member. Another step 2406 includes attaching the device guard to the storage member. Another step 2408 is to provide the storage member to the elongated member of the supply system while maintaining the position of the sheath of the supply system so that the elongated member passes through the storage member and is partially disposed within the device guard. Includes a step of applying an axial force towards . Another step 2410 includes positioning the loading puller within a notch defined by an elongated member of the supply system. Another step 2412 is an axial force towards the elongated member of the supply system away from the loading member until the first and second ends of the loading puller are disposed within the fourth portion of the loading member. Includes the step of applying. Another step 2414 includes removing the loading puller from the supply system and loading members. Another step 2416 comprises applying an axial force towards the loading member to the sheath of the supply system while maintaining the position of the elongated member until the sheath contacts the loading member. Another step 2418 is an axial force towards the elongated member away from the loading member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Includes the step of applying. Another step 2420 includes removing the supply system from the loading member.

Step 2404 can be realized as described above with respect to step 2304. Step 2406 can be implemented using any suitable device guard, such as the device guard described herein. In one alternative embodiment, step 2406 can be omitted from the method of loading implantable medical devices onto the supply system. Step 2408 can be implemented using any suitable supply system, such as the supply system described herein. Depending on the configuration of the storage member used in the method of loading the implantable medical device onto the supply system, the implantable medical device can have wettability in the loading process. 51 and 51A show a supply system 2422 partially disposed within the device guard 2424 and a loading puller 2426 disposed within a notch 2428 defined by an elongated member 2430. 52 and 52A show the loading puller 2426 in an open configuration. 53 and 53A show the sheath 2432 advanced towards the loading member 2434 so as to come into contact with the loading member 2434. When disposed within the supply system, the implantable medical device may be partially disposed on the grip member and may be entirely disposed in the vicinity of the tip. Optional steps include implanting an implantable medical device within the patient's body. Another optional step involves orienting the tip of the supply system to implantable medical devices using device guards. Another optional step involves removing the second cap from the loading member to expose the loading puller.

Although described above with respect to the exemplary method 2400 for various steps, alternative steps and optional steps, these steps, alternative steps and optional steps are exemplified in Method 1900, Exemplary Method 2000. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2100, an exemplary method 2200, an exemplary method 2300 and / or an exemplary method 2900. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

FIG. 54 shows another exemplary supply system 2510. The supply system 2510 is similar to the supply system 1410 shown in FIG. 30 and described above, except as detailed below. The supply system 2510 includes a sheath 2512, an elongated member 2514, a tip 2516, a grip member 2560, and a push member 2570.

In the illustrated embodiment, the push member 2570 is partially disposed within the lumen 2526 defined by the sheath 2512 and has a first end 2572, a second end 2574, a length 2575 and a length. It has a body 2576 that defines the lumen 2578, which extends throughout the 2575 and is sized and configured to accommodate a portion of the elongated member 2514. Optionally, the material forming the push member can include a radiopaque body filled for improved visualization, and / or the push member may include a grip member and / or a portion of the tip. Can be sized and configured to accept. The lumen 2526 defined by the sheath 2512 is sized to accommodate a portion of the elongated member 2514, a grip member 2560, an elongated member and / or an implantable medical device disposed on the grip member and a portion of the tip 2516. It is set and configured. However, alternative embodiments may include a sheath that defines a lumen sized and constructed so as not to accept a portion of the tip. When in use, if it is desirable to deploy an implantable medical device disposed within the lumen 2526 defined by the sheath 2512, the user may maintain the position of the elongated member 2514 and the push member 2570 while maintaining the tip. An axial force is applied to the sheath 2512 towards the first end 2530 of the elongated member 2514, which is directed away from 2516. Instead, the user applies an axial force directed at the sheath to the elongated member 2514 and the push member 2570 while maintaining the position of the sheath 2512. Once the second end 2522 of the sheath 2512 is positioned at a point between the grip member 2560 and the notch 2542, the user can maintain the position of the push member 2570 and the tip 2516 is of the sheath 2512. It is possible to apply an axial force away from the sheath to the elongated member 2514 so as to advance towards the second end 2522, or the second end 2574 of the push member 2570 is at the tip. Axial forces can be applied to the push member 2570 while maintaining the position of the elongated member 2514 so as to advance towards 2516 or beyond the second end 2548 of the tip 2516. It provides a mechanism for supplying implantable medical devices at the point of treatment.

FIG. 55 shows an alternative device guard 2615 that can be used with a loading member such as the loading member 1614 or any other suitable loading member further detailed herein. The device guard 2615 has a first end 2656, a second end 2658, and a body 2660 defining a base 2662, a first protrusion 2664, a second protrusion 2666, a third protrusion 2668 and a passageway 2670. Each of the first protrusion 2664 and the second protrusion 2666 extends from the base 2662 to the second end 2658 of the device guard 2615. The third protrusion 2668 extends from the base 2662 toward the second end 2658 to the end 2672 and has a longitudinal axis 2673. In the illustrated embodiment, the third protrusion 2668 has a length less than the length of each of the first and second protrusions 2664, 2666. When the device guard 2615 is attached to the loading member (eg, loading member 2814), the longitudinal axis 2673 of the third projection 2668 is coaxial with the axis of the passageway defined by the loading member. Each of the first and second protrusions 2664 and 2666 is arranged on a plane that does not come into contact with the longitudinal axis 2673. However, the alternative embodiment is disposed on a plane that includes or is in contact with the longitudinal axis of the third projection and / or has a length equal to or less than the length of the third projection. The first and second protrusions can be included. The body 2660 defines the passageway 2670 through the base 2662 and the third protrusion 2668. The passageway 2670 is sized and configured to accommodate a portion of the supply system (eg, elongated member, tip), as further detailed herein. Any suitable structure, such as a snap-fit connection, and any other structure deemed appropriate for a particular embodiment, such as those described herein, provides an releasable attachment to the device guard. It may be included on a device guard such as device guard 2615 to achieve.

56 and 57 show an exemplary loading assister 2710. The loading assister 2710 has a first end 2712, a second end 2714, a shaft 2716, and a hook 2718.

The shaft 2716 has a first end portion 2720, a second end portion 2722, and a body 2724 defining the first portion 2726 and the second portion 2728. The first portion 2726 has a width of 2727, a length of 2729, and a thickness of 2731. The second portion 2728 has a width of 2733, a length of 2735, and a thickness of 2737. The thickness 2737 of the second portion 2728 is equal to the thickness 2731 of the first portion 2726. The width 2733 of the second portion 2728 is smaller than the width 2727 of the first portion 2726 and is defined by the passageway and / or the loading member as the first and second tracks (eg, first and second). It is sized and configured to be accepted by Tracks 1090, 1092, 1st and 2nd Tracks 1658, 1662, 1st and 2nd Tracks 2858, 2862). The length 2733 of the second portion 2728 is greater than the length 2729 of the first portion 2726 and greater than the length of the passageways (eg, passageway 1032, passageway 1656, passageway 2856) defined by the loading member. In the illustrated embodiment, the width 2731 of the second portion 2728 is the fourth portion of the passageway defined by the loading member (eg, the fourth portion 1040 of the passageway 1032, the fourth portion 1670 of the passageway 1656, the fourth portion of the passageway 2856). The base of the first track and the base of the third track (eg, the base of the first track 1658 along the third portion 1668 of the passageway 1656), which is smaller than the width 1671 of the portion 2870) and along the third portion of the passageway of the loading member. It is less than the distance between the base 1651 and the base 1651) of the third track 1662. The thickness 2737 of the second portion 2728 is less than the thickness of each of the first and third tracks (eg, first and third tracks 1658, 1662) of the loading member defined by the loading member 1614. This structural configuration provides a mechanism for the loading assister to advance and then retract through the passageway defined by the loading member.

Hook 2718 is a separate component mounted to the second end 2722 of the shaft 2716 and has a first end 2740, a second end 2742, and a body 2744 defining curves 2746 and recesses 2748. .. Curve 2746 is defined between the first and second ends 2740, 2742. The recess 2748 extends from the second end 2742 and away from the first end 2740 and is part of a loading puller such as that described herein (eg, a third bend in the loading puller 652). The portion between the portion 668 and the fourth bent portion 670, curve 2768) is sized and configured to accommodate.

Although the loading assister 2710 is shown as having a particular structural configuration and having a hook mounted to the shaft, the loading assister can have any suitable structural configuration. .. The choice of suitable structural configuration may be based on various considerations such as the structural configuration of the loading member intended for the loading assister to pass through. For example, the loading assister may be a shaft having first and second parts of the same or different length, width and / or thickness, hooks and / or attached to any suitable part of the shaft (eg, eg). Hooks formed from the material forming the shaft can be defined (so that the shaft and hook are formed as a single integral component).

58, 59 and 60 show another exemplary loading puller 2752. The loading puller 2752 is similar to the loading puller 652 shown in FIGS. 16 and 16A and described above, except as detailed below.

In the illustrated embodiment, the loading puller 2752 has a longitudinal axis 2757, a first end 2758, a second end 2760, a length 2761, a first part 2763, a second part 2765, and a first. It has a bent portion 2764, a second bent portion 2766, a curve 2768, a third bent portion 2770, and a main body 2762 that defines a fourth bent portion 2772. The first bend 2764 is positioned in the vicinity of the first end 2758 between the first end 2758 and the second bend 2766, and the fourth bend 2772 is a medical device in which the loading puller 2752 can be implanted. When releasably mounted on the device, the loading puller defines two hooked ends 2774, 2776 adapted to partially surround a portion of the frame of the implantable medical device. It is positioned in the vicinity of the second end 2760 between the second end 2760 and the third bend 2770. The second bent portion 2766 is disposed between the first bent portion 2764 and the curve 2768, and the third bent portion 2770 defines a U-shaped member 2778 including a portion where the loading puller 2752 intersects with each other. As such, it is arranged between the curve 2768 and the fourth bent portion 2772.

The loading puller 2752 is adapted to be disposed within the loading member and has a first closed configuration shown in FIGS. 58 and 59 and a second open configuration shown in FIG. 60. It is possible to move between. The loading puller 2752 is urged to a closed configuration. In the closed configuration, the first portion 2763 overlaps the second portion 2765 so that the hooked ends 2772, 2774 are oriented away from each other. In the open configuration, the first portion 2763 does not overlap the second portion 2765, and the hooked ends 2772, 2774 have the first hooked end 2774 on the longitudinal axis 2757 of the loading puller 2752. On the other hand, they are oriented toward each other so as to be positioned opposite to the second hooked end 2776. The movement of the loading puller 2752 from the closed configuration to the open configuration is initially directed to the longitudinal axis 2757 of the loading puller 2752, and once the first and second parts pass the longitudinal axis 2757, from the longitudinal axis 2757. It can be realized by applying an axial force directed toward the distance to each of the first and second portions . As shown in FIG. 60, in order to attach the loading puller 2752 to the implantable medical device 2780, the loading puller 2752 is such that the loading puller 2752 is larger than the outer diameter of the implantable medical device 2780. It has been moved to an open configuration so that it has a width disposed between the hooked ends 2772, 2774. The loading puller 2752 then advances towards the implantable medical device, and the axial force is releasably attached to the implantable medical device 2780 by the loading puller 2752, and the hooked end 2772. , 2774 are removed from the first and second portions 2763, 2765 so that the width disposed between them is smaller than the outer diameter of the implantable medical device 2780. When mounted on a implantable medical device 2780, a portion of the loading puller 2752 (eg, hooked ends 2772, 2774) is loaded by the loading puller 2752 with an axial force along its longitudinal axis 2757. One or more openings 2781 defined by the frame of the implantable medical device 2780 so as to have the ability to apply an axial force to the implantable medical device 2780 when applied to the puller 2752. It is arranged inside. As shown in FIG. 60, removal of the loading puller 2752 from the releasable attachment to the implantable medical device 2780 is the time until the loading puller 2752 is free from the implantable medical device 2780. This can be achieved by applying an axial force away from the longitudinal axis 2757 to each of the first and second portions 2763 and 2765. Loading pullers, such as those described herein, can optionally be pre-attached to implantable medical devices (eg, disinfected implantable medical devices) and disinfected. It is also possible and / or can be disposed in a liquid material (eg, a holding material) in a sealed package. The loading puller 2752 provides a mechanism for maintaining attachment between the loading puller 2752 and the implantable medical device during use until an external force is applied to the loading puller 2752 and / or the implantable device. offer.

61, 62, 63, 64, 65 and 66 show another exemplary loading member 2814. The loading member 2814 is similar to the loading member 1614 shown in FIGS. 33, 35 and 35A and described above, except as detailed below.

In the illustrated embodiment, the loading member 2814 is formed as a single integral component. The loading member 2814 includes a longitudinal axis 2844, a first end 2846, a second end 2848, a first opening 2852, a second opening 2854, a passageway 2856, a first track 2858, and a second track 2860. It has a third track 2862, a fourth track 2877, and a main body 2850 that defines the guide passage way 2865. The passageway 2856 extends from the first opening 2852 to the second opening 2854, and has a first portion 2864, a second portion 2866, a third portion 2868, a fourth portion 2870, and a fifth portion 2872. Has. Each of the first track 2858 and the third track 2862 has a thickness of 2853. Each of the second track 2860 and the fourth track 2877 extends from the first end 2846 toward the fifth portion 2872 to a location within the third portion 2868. Each of the first track 2858 and the third track 2862 is sized and configured to accommodate a portion of the loading assister and / or loading puller and guides the loading assister and / or loading puller through the loading member 2814 during use. Provides the mechanism of. Each of the guide passageways 2865 extends from the first end 2846 into the body 2850 towards the second end 2848 and is an alignment and / or releasable fit between the loading member 2814 and the device guard. Is sized and configured to accommodate protrusions (eg, first protrusion 2664, second protrusion 2666) defined by a device guard (eg, device guard 2615).

FIG. 67 is a schematic representation of another exemplary method 2900 for loading implantable medical devices onto a supply system.

Step 2902 includes acquiring an implantable medical device with a mounted loading puller. Another step 2904 comprises removing implantable medical devices and loading pullers from the container. Another step 2906 includes rinsing off implantable medical devices and loading pullers. Another step 2908 includes advancing the loading assister through a passageway defined by a loading member. Another step 2910 includes mounting the loading assister on the loading puller. Another step 2912 includes retracting the loading assister from the loading member. Another step 2914 comprises removing the loading assister from the loading puller. Another step 2916 includes attaching the device guard to the loading member. Another step 2918 comprises applying an axial force towards the loading member to the elongated member of the supply system so that it passes through the loading member and is partially disposed within the device guard. Another step 2920 comprises positioning the loading puller within a notch defined by an elongated member of the supply system. Another step 2922 is an axial force directed away from the loading member on the elongated member of the supply system until the first and second ends of the loading puller are disposed within the fourth portion of the loading member. Includes the step of applying. Another step 2924 comprises removing the loading puller from the supply system and loading members. Another step 2926 maintains the position of the elongated member until the sheath contacts the loading member (eg, disposed within the loading member and contacts a portion of the loading member (eg, shoulder)) . It involves applying an axial force towards the loading member to the sheath of the supply system. Another step 2928 is an axial force towards the elongated member away from the loading member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Includes the step of applying. Another step 2930 includes removing the supply system from the loading member.

Step 2902 acquires any suitable implantable medical device having any suitable pre-mounted loading puller, such as the loading puller 2752, and the implantable medical device 2780 shown in FIG. This can be achieved. Implantable medical devices and pre-mounted loading pullers can be placed in containers filled with retaining material. Instead, step 2902 includes a variety of separate steps, including obtaining an implantable medical device, removing the implantable medical device from the container, and attaching the loading puller to the implantable medical device. Can include steps. Alternatively, step 2902 can be omitted from method 2900.

Step 2904 can be accomplished using any suitable method or technique for removing implantable medical devices and pre-mounted loading pullers from the container. Alternatively, step 2904 can be omitted from method 2900.

Step 2906 is accomplished using any method or technique for rinsing implantable medical devices and / or loading pullers and any suitable rinsing material such as those described herein. can do. Alternatively, step 2906 can be omitted from method 2900.

Step 2908 is accomplished using any suitable loading assister, such as the loading assister 2710, and any suitable loading member, such as those described herein (eg, loading puller 2814). Can be done. Step 2908 is an axis toward the passageway defined by the loading member in the loading assister while maintaining the position of the loading member until the second end of the loading assister passes through the passageway defined by the loading member. This can be achieved by applying a directional force or by applying an axial force towards the loading assister to the loading member. Alternatively, step 2908 can be realized by maintaining the position of the loading assister while applying an axial force towards the loading assister to the loading member.

Step 2910 is a recess (eg, eg, a portion of the loading puller 652 between the second bend 666 and the third bend 668, the curve 2768 of the loading puller 2752) defined by a loading assister. It can be realized by advancing into the recess 2748). Optionally, step 2910 can be implemented such that the loading puller, loading assister and implantable medical device are vertically positioned. 68 is the loading assister 2710, the loading assister 2710 shown in FIGS. 56 and 57, advanced through the loading member 2814 shown in FIGS. 61, 62, 63, 64, 65 and 66. 58, 59 and 60 are shown in FIGS. 58, 59 and 60, which are releasably mounted and free from the loading member 2814 (eg, a curve 2768 disposed in a recess 2748 defined by a loading assister 2710). The loading puller 2752 and the implantable medical device 2780 releasably mounted on the loading puller 2752 are shown. In the illustrated embodiment, the loading member 2814 is made of a transparent material.

Step 2912 maintains the position of the loading assister until the second end of the loading assister passes through the passageway defined by the loading member and the loading assister is freed from the loading member. This can be achieved by applying an axial force toward the loading member away from the loading member, or by applying an axial force toward the loading member away from the loading assister . Alternatively, step 2912 can also be realized by maintaining the position of the loading assister while applying an axial force towards the loading member away from the loading assister. Optionally, step 2912 can be implemented such that the loading puller, loading assister and implantable medical device are vertically positioned. FIG. 69 shows a medical device 2780 free from the loading member 2814, with the loading puller 2752 releasably mounted on the loading assister 2710 and partially disposed within the loading member 2814, and the implantable medical device 2780. Shown is a loading assister 2710 retracted from the loading member 2814 so as to be releasably mounted on the 2752 and disposed entirely within the loading member 2814.

Step 2914 is a portion of the loading puller from a recess (eg, recess 2748) defined by the loading assister (eg, between the second bend 666 and the third bend 668 of the loading puller 652, the loading puller 2752. This can be achieved by retreating the curve 2768). FIG. 70 shows a loading puller 2752, which is free from the loading assister and is partially disposed within the loading member 2814, and which is releasably mounted on the loading puller 2752 and wholly disposed within the loading member 2814. The implantable medical device 2780 and the like.

Step 2916 can be implemented using any suitable device guard (eg, device guard 2615), such as the device guard described herein. Step 2916 maintains the position of the loading member until the device guard is releasably attached to the loading member (eg, the first and second projections 2664, 2666 are disposed within the guide passage way 2865). However, this can be achieved by applying an axial force toward the loading member to the device guard or by applying an axial force toward the device guard to the loading member. Alternatively, step 2916 can be realized by maintaining the position of the device guard while applying an axial force towards the device guard to the loading member. FIG. 70 shows the device guard 2615 mounted on the loading member 2814.

Step 2918 can be implemented using any suitable supply system, such as the supply system described herein (eg, supply system 2510). Step 2918 serves while maintaining the position of the supply system (eg, sheath, push member) and the rest of the loading member until the second end of the elongated member passes through the passageway defined by the loading member. An axial force towards a passageway defined by the loading member is applied to a portion of the feeding system (eg, elongated member 2514), or an axial force towards a portion of the feeding system (eg , elongated member) to the loading member. It can be realized by applying the force of. Alternatively, step 2918 can be accomplished by applying an axial force towards the loading assister to the loading member while maintaining the position of a portion of the supply system (eg, an elongated member).

Step 2920 can be accomplished by applying a force to the loading puller towards the notch defined by the elongated member of the supply system until the loading puller (eg, curve 2768) is disposed in the notch. can. FIG. 71 shows a supply system 2510 partially disposed within the device guard 2615 and the loading member 2814, and a loading puller 2752 disposed within the notch 2542 defined by the elongated member 2514. In addition, FIG. 71 shows a loading puller 2752 partially disposed within the loading member 2814 and a releasably mounted implantable implantable implant that is releasably mounted within the loading member 2814 and is entirely disposed within the loading member 2814. 2780 is a medical device.

Step 2922 moves away from the loading member to the elongated member while maintaining the position of the loading member until the first and second ends of the loading puller are disposed within the fourth portion of the loading member. This can be achieved by applying an axial force or by applying an axial force to the loading member in a direction away from the elongated member . Alternatively, step 2922 can also be realized by maintaining the position of the elongated member while applying an axial force to the loading member towards a distance away from the elongated member. As the implantable medical device is compressed within the loading member, part or all of the implantable medical device is crushed onto the grip member, thereby providing the grip member and the implantable medical device. Friction is provided between.

In an embodiment in which the loading puller 2752 is used in method 2900, step 2924 is longitudinal to each of the first and second portions 2763, 2765 until the loading puller 2752 is free from the implantable medical device 2780. This can be achieved by applying an axial force away from the directional axis 2757 and then applying an axial force away from the loading member to the loading puller. In an embodiment in which the loading puller 652 is utilized in method 2900, step 2924 can be realized by applying an axial force to the loading puller towards away from the loading member .

Although described above with respect to the exemplary method 2900 for various steps, alternative steps and optional steps, these steps, alternative steps and optional steps are described in the exemplary method 1900, exemplary method 2000. , The methods, steps, alternative steps and / or optional steps described herein with respect to an exemplary method 2100, an exemplary method 2200, an exemplary method 2300 and / or an exemplary method 2400. It can be included within, can be realized at the same time, and / or can be realized as an alternative form thereof.

The exemplary storage devices, loading devices, guide systems, supply systems, loading pullers and methods described herein reduce the complexity of disinfection, storage, rinsing and / or loading of implantable medical devices. It provides a mechanism for reducing and minimizing the risks associated with the handling of implantable medical devices intended for implantation. For example, exemplary storage devices, loading devices, guide systems, supply systems and methods described herein interact with implantable medical devices during disinfection, storage, rinsing and / or loading. Provides a mechanism for disinfecting, storing, rinsing and / or loading implantable medical devices using a closure system that reduces.

Those skilled in the art will appreciate that various modifications and modifications of the embodiments described and illustrated may be implemented in light of the overall teachings of the present disclosure. Accordingly, the particular configurations disclosed are for purposes of illustration only and limit the scope of the invention to which the claims and any and all equivalents thereof are to be given the full scope. Please interpret it as something that does not.

Claims (26)

A method of loading implantable medical devices onto a supply system.
Steps to position implantable medical devices within the loading member,
A step of positioning a portion of an elongated member of a feeding system within the loading member, wherein the feeding system includes the elongated member, a sheath, and a gripping member, the elongated member being partially in the sheath. Disposed, having a first end and a second end, the gripping member is attached to the elongated member between the first end of the elongated member and the second end of the elongated member. Have been, steps and
A step of crushing the implantable medical device onto the gripping member,
A step of applying a force to the sheath while maintaining the position of the elongated member until the sheath comes into contact with the loading member.
Axial forces on the elongated member towards away from the loading member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Steps to apply and
The step of removing the supply system from the loading member,
How to prepare. The supply system comprises a tip disposed at the second end of the elongated member.
The method of claim 1, wherein the gripping member is attached to the elongated member between the first end and the tip of the elongated member. The step of attaching the device guard to the loading member and
A step of applying force to the elongated member of the supply system so that the supply system is partially disposed within the loading member and the device guard.
The method according to claim 1, further comprising. The method of claim 1, wherein the implantable medical device comprises a frame and a material mounted on the frame. The method of claim 4, wherein the implantable medical device is a venous valve. The method according to claim 4, wherein the material mounted on the frame is a natural material. The method of claim 4, wherein the frame is an inflatable frame. The loading member has a first end, a second end, and a passageway, wherein the passageway has a first portion, a second portion, a third portion, a fourth portion, and a fifth portion. The first portion extends from the first end portion of the loading member to the second portion and has a constant inner diameter, and the second portion extends from the first portion to the third portion. The third portion has an inner diameter tapered from the first portion to the third portion, and the third portion extends from the second portion to the fifth portion at the first end portion of the loading member. The fourth portion has an inner diameter smaller than the inner diameter of the first portion, and the fourth portion extends from the third portion to the second end portion of the loading member and has a width larger than the inner diameter of the third portion. The fifth portion extends from the third portion to the second end portion of the loading member, and has an inner diameter smaller than the width of the fourth portion and larger than the inner diameter of the third portion. The method according to claim 1. The reduction in the inner diameter between the fifth portion and the third portion creates a shoulder in the passageway defined by the loading member.
The eighth aspect of the present invention, wherein the step of applying the force to the sheath while maintaining the position of the elongated member until the sheath contacts the loading member is performed until the sheath contacts the shoulder. Method. The method of claim 1, wherein the gripping member is made of a polymer. The step of positioning the implantable medical device in the loading member comprises a step of positioning the implantable medical device and the loading puller in the loading member, wherein the loading puller is the implantable medical device. The method according to claim 1, which is mounted on the device. The step of positioning the implantable medical device and the loading puller within the loading member
A step of advancing the loading assister through the passageway defined by the loading member, and
The step of attaching the loading assister to the loading puller,
A step of retracting the loading assister from the loading member such that the loading puller is partially disposed within the loading member and the implantable medical device is entirely disposed within the loading member. When,
The step of removing the loading assister from the loading puller,
11. The method of claim 11. The loading assister has a hook, the hook having a first end, a second end, and a body defining curves and recesses.
12. The method of claim 12, wherein the step of attaching the loading assister to the loading puller is performed by advancing a portion of the loading puller into the recess defined by the loading assister. A step of retracting the loading assister from the loading member such that the loading puller is partially disposed within the loading member and the implantable medical device is entirely disposed within the loading member. The method of claim 12, wherein the method is performed while the loading puller, loading assister, and implantable medical device are vertically positioned. 11. The method of claim 11, wherein the elongated member defines a notch. 15. The method of claim 15, further comprising positioning the loading puller within the notch defined by the elongated member. The loading puller can be placed in the supply system, the loading member, and the implant before the step of applying force to the sheath while maintaining the position of the elongated member until the sheath contacts the loading member. 16. The method of claim 16, further comprising removing from the medical device. The loading puller has a first portion and a second portion and is movable between a first closed configuration and a second open configuration, wherein in the first closed configuration the first portion is said. 17. The method of claim 17, which is adapted to overlap the second portion. The loading puller has a longitudinal axis and
The first and second portions until the step of removing the loading puller from the supply system, the loading member, and the implantable medical device is free from the implantable medical device. 18. The method of claim 18, wherein an axial force is applied to each of the above-mentioned longitudinal forces toward a direction away from the longitudinal axis. 15. The method of claim 15, wherein the gripping member is disposed between the notch and the second end of the elongated member. The loading puller has a first end, a second end, and a body, which defines a first bend, a second bend, a curve, a third bend, and a fourth bend. The first bent portion is arranged between the first end portion and the second bent portion of the loading puller, and the second bent portion is arranged between the first bent portion and the curve. The third bent portion is arranged between the curve and the fourth bent portion, and the fourth bent portion is arranged between the second end portion and the third bent portion of the loading puller. 18. The method of claim 18, wherein the loading puller defines two hooked ends that partially surround a portion of the implantable medical device. The implantable medical device comprises a frame and materials mounted on the frame, wherein the frame defines one or more openings.
11. The method of claim 11, wherein the loading puller is disposed in the one or more openings. The loading member has a first end, a second end, and a passageway, wherein the passageway has a first portion, a second portion, a third portion, a fourth portion, and a fifth portion. The first portion extends from the first end portion of the loading member to the second portion and has a constant inner diameter, and the second portion extends from the first portion to the third portion. The third portion has an inner diameter tapered from the first portion to the third portion, and the third portion extends from the second portion to the fifth portion at the first end portion of the loading member. The fourth portion has an inner diameter smaller than the inner diameter of the first portion, and the fourth portion extends from the third portion to the second end portion of the loading member and has a width larger than the inner diameter of the third portion. It has a width and extends from the fifth portion, the third portion to the second end portion of the loading member, and has an inner diameter smaller than the width of the fourth portion and larger than the inner diameter of the third portion. The method according to claim 11. The loading puller has a first end and a second end.
23. The method of claim 23, further comprising positioning the first and second ends of the loading puller within the fourth portion of the loading member. A method of loading implantable medical devices onto a supply system.
A step of positioning the implantable medical device and the loading puller mounted on the implantable medical device in the loading member, and
A step of applying an axial force towards the loading member to an elongated member of the feeding system such that the feeding system is partially disposed within the loading member, wherein the feeding system is the elongated member. The elongated member is partially disposed within the sheath, has a first end and a second end, and defines a notch, wherein the grip member is the cut. A step and a step attached to the elongated member between the notch and the second end of the elongated member.
A step of positioning the loading puller within the notch defined by the elongated member, and
A step of applying an axial force to the elongated member away from the loading member so that the implantable medical device collapses onto the grip member.
A step of removing the loading puller from the supply system, the loading member, and the implantable medical device.
A step of applying an axial force toward the loading member to the sheath while maintaining the position of the elongated member until the sheath comes into contact with the loading member.
Axial forces on the elongated member towards away from the loading member while maintaining the position of the sheath so that the elongated member is retracted from the loading member and the medical device advances into the sheath. Steps to apply and
The step of removing the supply system from the loading member,
How to prepare. A method of loading implantable medical devices onto a supply system.
A step of positioning the implantable medical device and loading puller within the loading member, wherein the implantable medical device comprises an inflatable frame and a natural material mounted on the frame, the frame. Demarcates one or more openings, and the loading puller is partially disposed within the one or more openings, with a step.
A step of applying an axial force towards the loading member to an elongated member of the feeding system such that the feeding system is partially disposed within the loading member, wherein the feeding system is the elongated member. The elongated member is partially disposed within the sheath, includes a first end and a second end, and defines a notch, wherein the grip member comprises the cut. A step and a step attached to the elongated member between the notch and the second end of the elongated member.
A step of positioning the loading puller within the notch defined by the elongated member, and
A step of applying an axial force toward the elongated member away from the loading member so that the implantable medical device collapses on the grip member.
A step of removing the loading puller from the supply system, the loading member, and the implantable medical device.
A step of applying an axial force toward the loading member onto the sheath while maintaining the position of the elongated member until the sheath comes into contact with the loading member.
Axial forces on the elongated member towards away from the loading member while maintaining the position of the sheath so that the elongated member retracts from the loading member and the medical device advances into the sheath. Steps to apply and
The step of removing the supply system from the loading member,
How to prepare.