No touch sterile medical device packaging

A packaging assembly may retain a sterile medical device for use in a surgical setting, such as an orthopedic implant or instrument. The packaging assembly may have a first packaging component and a second packaging component. The first packaging component and the second packaging component may be attachable to each other to define a first interior space containing the medical device. The first packaging component may have a first retention feature that defines a first interior receptacle shaped to receive at least part of the medical device such that a user can manually grip the medical device through the first retention feature. The first interior space may be manually opened by a user grasping the medical device through the first retention feature.

TECHNICAL FIELD

The present disclosure relates to packaging systems, and more specifically, packaging for keeping medical devices, such as surgical implants and instruments, in a sterile condition until use.

BACKGROUND

In many cases, medical implants or instruments must be sterilized, and stored in a sterile condition, until they are to be used. Many types of packaging are used to provide a hermetic seal to maintain such a sterile condition. However, significant drawbacks are present with many known packaging types. Some packaging assemblies are bulky, heavy, expensive, and/or difficult to open. Many do not have any mechanism whereby the user can easily keep the medical device from contamination after the packaging has been opened and before surgical use. In many instances, sterile packaging is opened outside the sterile field, and a practitioner with contaminated fingers or gloves may inadvertently touch the medical device, rendering it unusable.

SUMMARY

In some embodiments, a packaging assembly may be provided, for retaining a medical device, such as an implant or instrument, for use in a surgical setting. The packaging assembly may have a first packaging component and a second packaging component. The first packaging component and the second packaging component may be attachable to each other to define a first interior space containing the medical device. The first interior space may be sealed from ambient space. The first packaging component may have a first retention feature that defines a first interior receptacle shaped to receive at least part of the medical device such that a user can manually grip the medical device through the first retention feature.

The first retention feature may further define a first recess proximate the medical device. The first recess may be shaped to receive at least part of a user's hand.

The medical device may have a first end and a second end. The first recess may have a substantially annular shape that defines the first interior receptacle. The first interior receptacle may be shaped to receive the first medical device end.

The second packaging component may have a second retention feature that defines a second interior receptacle that receives the second medical device end.

The medical device may have a first end and a second end. The second packaging component may have a first end at which the second packaging component is secured to the first packaging component, and a second end defining a base capable of supporting the packaging assembly in an upright orientation, with the first packaging component over the second packaging component, and the medical device upright with the first end over the second end.

The first packaging component may be detachable from the second packaging component in response to manual exertion of a detachment force exerted by a user gripping the medical device through the first retention feature.

The packaging assembly may further have a third packaging component securable to the second packaging component to define a second interior space between the first interior space and an ambient space outside the packaging assembly.

The packaging assembly may further have a cap securable to the first packaging component. The cap may define a seal that seals the first interior space from ambient space.

The medical device may have a first medical device end and a second medical device end. The second packaging component may have a second retention feature that defines a second interior receptacle. With the first packaging component and the second packaging component attached to each other to define a first interior space, the first medical device end may reside in the first interior receptacle and the second medical device end may reside in the second interior receptacle.

In some embodiments, a method may be used to remove a medical device, for use during a surgical procedure, from a packaging assembly. The method may include grasping a first packaging component of the packaging assembly by grasping the medical device through a first retention feature of the first packaging component, with the medical device residing in an interior space between the first packaging component and a second packaging component of the packaging assembly. The method may further include grasping the second packaging component and, with the medical device grasped through the first retention feature, exerting a detachment force to detach the first packaging component from the second packaging component to access a first interior space between.

The first retention feature may further define a first interior receptacle. Grasping the medical device through the first retention feature may include grasping the medical device with at least part of the medical device residing in the first interior receptacle.

The first retention feature may further have a first recess. Grasping the medical device through the first retention feature may further include inserting at least part of a user's hand into the first recess.

The medical device may have a first device end and a second device end. The first recess may have a substantially annular shape that defines the first interior receptacle. Grasping the device through the first retention feature may further include grasping the first device end with the first device end residing in the first interior receptacle.

The second packaging component may have a second retention feature that defines a second interior receptacle. Grasping the second packaging component may include grasping the second packaging component with the second device end residing in the second interior receptacle.

The method may further include grasping a third packaging component secured to the second packaging component to define a second interior space between the first interior space and an ambient space outside the packaging assembly, and exerting a second detachment force to break a second seal between the third packaging component and the second packaging component to access the second interior space.

The method may further include grasping a cap secured to the second packaging component, and exerting a second detachment force to detach the cap from the first packaging component and break a seal between the cap and the first packaging component.

The medical device may have a first device end and a second device end. The second packaging component may have a second retention feature that defines a second interior receptacle. Grasping the second packaging component of the packaging assembly may include grasping the second packaging component of the packaging assembly with the second device end residing in the second interior receptacle.

According to some embodiments, a system may include a medical device for use during a surgical procedure, which may be an implant or instrument. The medical device may have a first device end and a second device end. The system may further include a packaging assembly with a first packaging component with a first retention feature that defines a first interior receptacle in which the first device end resides, and a recess sized to receive at least part of a hand of a user and shaped to permit the user to compress the first interior receptacle against the first end of the device. The packaging assembly may further include a second packaging component with a second retention feature that defines a second interior receptacle in which the second device end resides. The first packaging component and the second packaging component may be attachable to each other to define a first interior space containing the medical device in a sealed condition.

The system may further have a third packaging component securable to the second packaging component to define a second interior space between the first interior space and an ambient space outside the packaging assembly.

The first packaging component may be detachable from the second packaging component in response to manual exertion of a detachment force exerted by a user gripping the medical device through the first retention feature.

It is to be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent limitations to the scope of the disclosure.

DETAILED DESCRIPTION

Exemplary embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the invention, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method, as represented inFIGS. 1 through 5C, is not intended to limit the scope of the invention, as claimed in this or any other application claiming priority to this application, but is merely representative exemplary of exemplary embodiments of the invention.

The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature. The phrase “manually touching” refers to touching an object with hands or other body parts, without regard as to whether the hands or other body parts are gloved or otherwise protected. “Without manually touching” refers to an action that is carried out on an object without touching the object with hands or other body parts, without regard as to whether the hands or other body parts are gloved or otherwise protected.

Referring toFIGS. 1, 2A, 2B, 2C, and 3, a side elevation, section view, a plan view, an alternative side elevation section view, a perspective view, and a side elevation, exploded view show a packaging assembly100, according to one embodiment. The packaging assembly100may be used to contain a medical device110, which may be any type of device that is usable in a surgical environment, such as a surgical implant or instrument. For example, the medical device110may be a bone screw, a spinal stabilization rod, an intervertebral implant, a stent, or any other implantable device known in the medical arts. In alternative embodiments, the medical device110may be an instrument retained in sterile condition in the packaging assembly100.

FIG. 4is a side elevation view of the packaging assembly100, with the packaging assembly100open to permit removal of the medical device110. In some embodiments, the medical device110may already be packaged in another form of sterile packaging prior to insertion into the packaging assembly100. The retaining features of the packaging assembly100can then engage the other sterile packaging. In such a situation, the packaging assembly100may provide a second sterile barrier to further protect the medical device110from contamination.

In the exemplary embodiment ofFIG. 1, the medical device110is shown as a spinal stabilization rod, and may thus have a generally cylindrical, elongated shape. The medical device110may have a first end112and a second end114. The medical device110may be used for posterior vertebral stabilization, in connection with a series of pedicle screws with polyaxially-adjustable rod receivers (not shown).

In order to avoid introduction of infection in the surgical site, it may be desirable for the medical device110to remain sterile until it is needed. Accordingly, in addition to safely storing the medical device110, the packaging assembly100may maintain the medical device110in a sterile environment until it is time to use the medical device110surgically. Optionally, the packaging assembly100may enable an operator to remove the medical device110from the packaging assembly100without requiring the operator to manually touch the medical device110, thus preserving the sterile state of the medical device110. The medical device110may then, in its sterile state, be transferred directly to the sterile field or the surgical site for use.

According to some embodiments, the packaging assembly100may have a first packaging component120, a second packaging component122, and a third packaging component124. In some embodiments, the first packaging component120, the second packaging component122, and the third packaging component124may each be generally radially symmetrical about an axis125of the first packaging component120. The second packaging component122may seat securely into the first packaging component120.

In some embodiments, the first packaging component120and the second packaging component122may be seated together in a manner that provides a seal. However, in alternative embodiments, no seal may be provided by the interface between the first packaging component120and the second packaging component122. Rather, a cap160may be sealed onto the first packaging component120to create the sterile seal. The cap160may be a Tyvek layer or the like. In other embodiments, the packaging assembly100may provide multiple seals, for example, with a first seal between the first packaging component120and the second packaging component122, and a second seal between the first packaging component120and the cap160.

The first packaging component120and the second packaging component122may be complementarily shaped such that they can be easily secured together to define a first interior space126between them. Further, the third packaging component124may be complementarily shaped with the first packaging component120and/or the second packaging component122such that the third packaging component124can be secured to the first packaging component120and/or the second packaging component122. In some embodiments, the third packaging component124may be secured to the first packaging component120to define a seal. This may be done in addition to, or in the alternative to, seals between the first packaging component120and the third packaging component124and/or the cap160. Attachment of the third packaging component124to the first packaging component120may define a second interior space128generally between the second packaging component122and the third packaging component124. The medical device110may reside in the first interior space126. The second interior space128may, if sealed, provide a supplemental seal between the first interior space126and an ambient space129outside the packaging assembly100.

The second packaging component122may have a first end130, a second end132, a shoulder134, and a retention feature136. The first end130may be generally open toward the third packaging component124, such that the second interior space128is accessible through the first end130. The second interior space128may generally reside within the first packaging component120. The second end132may be closed to provide a barrier, and in some embodiments a seal, between the first interior space126and the second interior space128. In embodiments in which the first packaging component120is sealed to the second packaging component122, the shoulder134may provide a generally annular surface that can readily be attached to and/or sealed against the second packaging component122, as will be described subsequently.

The retention feature136may retain the first end112of the medical device110in such a manner that the first end112can be gripped through the second packaging component122. More particularly, the retention feature136may have a recess138with a generally annular shape that surrounds the first end112, to define a second interior receptacle139that receives the first end112. The recess138may be sized such that an operator, such as a surgeon or other clinician, can insert the tips of his or her fingers and/or thumb into the recess138and grip the first end112of the medical device110through the second packaging component122. This may facilitate removal of the medical device110from the packaging assembly100without requiring the clinician to touch the medical device110with his or her fingers or gloves.

The generally annular shape of the recess138is merely exemplary. In alternative embodiments, a wide variety of other shapes may be used. According to one alternative embodiment (not shown), multiple distinct recesses may be used for different digits of the user. For example, a first recess may receive the user's thumb and a second recess may receive one or more of the user's fingers. The user may compress the adjacent walls of the recesses toward each other to grip the medical device between the first and second recesses.

Notably, the existence of a recess is optional. In some alternative embodiments (not shown), a retention feature may define an interior receptacle that can receive at least part of a medical device, but may not define a recess in which the user's hand is received. Rather, the receptacle may be defined by the interior of a boss or other projecting feature that can be grasped by hand. Such a projecting feature need not be positioned within a recess, but may instead protrude from the surrounding surface(s) of the packaging component of which it is a part.

Returning to the packaging assembly100ofFIGS. 1 through 4, the first packaging component120may have a first end140, a second end142, a shoulder144, and a retention feature146. The first end140may be open toward the third packaging component124such that the first interior space126and the second interior space128are both accessible through the first end140. The first interior space126and the second interior space128may both reside within the first packaging component120. The first end140may define a flange141that facilitates sealed attachment of the cap160to the first packaging component120, as will be described subsequently.

The second end142may be closed to keep the first interior space126separate from and sealed from the ambient space129. The second end142may define a bottom surface143that may rest on a horizontal surface in such a manner that the packaging assembly100is stable and upright, maintaining the medical device110in a generally vertical orientation.

The shoulder144may have a generally annular shape that abuts a corresponding generally annular shape of the shoulder134of the second packaging component122. This abutment may be a mechanical coupling only, such as a snug friction fit, or may include a seal, as discussed above. In some embodiments, the shoulder134and the shoulder144may optionally be bonded, welded, mechanically fastened, or otherwise secured together. In some embodiments, where the first packaging component120and the second packaging component122are both formed of plastic materials, ultrasonic welding or other polymer attachment methods may be used to secure the shoulder134to the shoulder144, forming a mechanical attachment and/or a seal between the shoulder134and the shoulder144. In alternative embodiments, any other form of attachment may be used, including but not limited to mechanical fastening (for example, threaded interconnection, bayonet fittings, clips, clasps, and the like), adhesive bonding, chemical bonding, and the like.

The retention feature146may be configured somewhat similarly to the retention feature136of the second packaging component122, and may retain the second end114of the medical device110in a manner similar to retention of the first end112of the medical device110by the retention feature136of the second packaging component122, as described previously. More precisely, the retention feature146may have a recess148with a generally annular shape that surrounds the second end114, to define a first interior receptacle149that receives the second end114. The recess148may optionally be large enough to accommodate fingertips, but in the alternative, the recess148maybe significantly smaller than the recess138of the second packaging component122, as the operator need not grip the second end114of the medical device110through the first packaging component120, but may instead simply grip the exterior of the second packaging component122as the first end112of the medical device110is gripped through the recess138(for example, with the operator's other hand) and pulled out of the first interior space126. Thus, the retention feature146may simply provide retention force sufficient to retain the second end114of the medical device110against the second end142of the first packaging component120until the medical device110is to be removed from the packaging assembly100. The retention feature146may help to keep the medical device110in a stable, upright orientation until it is to be used.

The third packaging component124may be generally disc-shaped, with a central expanse154and a rim156, which may protrude from the central expanse154toward the first packaging component120and the second packaging component122. The outer annular region of the central expanse154may abut the flange141of the first packaging component120. In some embodiments, this outer annular region of the central expanse154may be attached and/or sealed to the flange141. However, this optional; in some embodiments, the third packaging component124may not be sealed to any other component, and may instead act as a protective cap. As with attachment of the shoulder134to the shoulder144, any known attachment technique may be used, such as welding, bonding, mechanical fastening, and/or the like. In embodiments in which the third packaging component124does not define a seal, it may provide a simple friction fit or the like with the first packaging component120.

In some embodiments, the attachment of the central expanse154to the flange141, and the attachment of the shoulder134to the shoulder144, may be manually breakable (i.e., breakable by hand, without the need for tooling). Thus, a user may be able to open the packaging assembly100and withdraw the medical device110without the need for any particular tool.

The first packaging component120, the second packaging component122, and the third packaging component124may be formed of a variety of materials. The first packaging component120, the second packaging component122, and/or the third packaging component124may optionally be made of translucent or transparent materials to facilitate user recognition of the medical device110, without needing to open the packaging assembly100. In some embodiments, one or more polymers may be used. For example, the first packaging component120, the second packaging component122, and/or the third packaging component124may be composed of polyethylene terephthalate (PET), or any other materials known in the art suitable for use in sterilization processes.

Various components of the packaging assembly100may optionally be shaped to help prevent inadvertent non-sterile access to the first interior space126. For example, the diameter of the second packaging component122may be large enough that a user gripping the second packaging component122via the recess138may be unable to move fingers of the gripping hand around the rim of the second packaging component122, proximate the first end130of the second packaging component122. Similarly, the first packaging component120may have a combination of length and diameter sufficient that a user gripping the first packaging component120via the recess148may be unable to move fingers of the gripping hand around the rim of the first packaging component120, proximate the first end140of the first packaging component120.

A user gripping the packaging assembly100to open the packaging assembly100need not have hands in a sterile condition. The user may be physically blocked from inserting potentially non-sterile digits into the first interior space126. Thus, accidental contamination of the medical device110may be avoided.

Optionally, the packaging assembly100may have a protective insert158that holds the first end112of the medical device110within the second interior receptacle139. The protective insert158may be a, rubber cap, or other member that covers the first end112. The protective insert158may protect the first end112from damage during storage or use, or may protect other devices or individuals from harm that could otherwise be caused by the first end112. For example, if the first end112has a sharp end, serrations, or other features that could cause harm or damage, the protective insert158may help prevent such harm or damage. It may be removed prior to or during surgical use of the medical device110.

In addition or in the alternative to serving a protective function, the protective insert158may enhance the ability of the second interior receptacle139to securely grip the first end112of the medical device110. The protective insert158is an optional feature; in some embodiments, it may be omitted in favor of direct retention of the first end112within the second interior receptacle139. The protective insert is not shown inFIGS. 2, 3, and 4.

In the exemplary embodiment ofFIGS. 1-4, the medical device110is stored such that the first end112of the medical device110is already retained in the second interior receptacle139. In alternative embodiments (not shown), a medical device may be stored such that the portion of the medical device that is to be gripped through the packaging is not disposed within the receptacle that is to be used to grip and withdraw it. Rather, prior to withdrawing the medical device, the receptacle and/or the medical device may be maneuvered to insert the portion of the medical device into the receptacle, where it can be gripped by the packaging. In some embodiments, a portion of the packaging having the receptacle (for example, a lid) may be sized to be insertable into the interior space containing the medical device, so that it can be maneuvered by the user to reach into the packaging and grip the medical device.

In some embodiments, an assembly may have an interior receptacle that flexes to permit the user to selectively grip the medical device. For example, with reference to the packaging assembly100ofFIGS. 1-4, the second interior receptacle139may be flexible so that the user can, in some configurations, grip the first end112of the medical device110, and in other configurations, not grip the medical device110. For example, the second interior receptacle139may have an undeflected shape in which the second interior receptacle139is significantly larger than the first end112, so that the first end112is freely insertable into and removable from the second interior receptacle139. The second interior receptacle139may further have a deflected shape that can be obtained by manually compressing the second interior receptacle139with fingers within the recess138. In the deflected shape, the second interior receptacle139may fit more tightly around the first end112, so that the first end112can be gripped in the second interior receptacle139until the user relaxes his or her grip on the second interior receptacle139. Thus, the user may have the option to release the medical device110without having to actively pull it from the second interior receptacle139(for example, with a second hand). Such a variable-shaped receptacle may be particularly useful for configurations in which the medical device is not stored in the receptacle.

Returning to the embodiment ofFIGS. 1-4, the packaging assembly100may be assembled in a variety of ways. The medical device110may first be inserted into the first interior space126. The second end114of the medical device110may be inserted into the first interior receptacle149of the second packaging component122. Then, the second packaging component122may be inserted through the first end140of the first packaging component120, such that the first end112of the medical device110enters the second interior receptacle139of the second packaging component122. The shoulder134may then be secured to the shoulder144, optionally sealing the first interior space126such that the first interior space126, and thus the medical device110, is isolated from the ambient space129.

In some embodiments, a cap160(shown inFIG. 3) may be used to provide a seal. The cap160may, for example, be secured to the flange141of the first packaging component120and may reside within the third packaging component124when the packaging assembly100is fully assembled. In some embodiments, the cap160may be secured to the flange141so as to form a seal that effectively isolates the first interior space126and the second interior space128from the ambient space129. Any attachment method may be used, such as the ultrasonic welding, mechanical fastening, chemical bonding, and adhesive bonding techniques mentioned previously.

The third packaging component124may then be positioned such that the central expanse154abuts the cap160. In some embodiments, a hermetic seal may be formed between the outer annular ring of the central expanse154and the flange141of the first packaging component120. Such a seal may be used in addition to or in place of the seal provided between the cap160and the first packaging component120. In alternative embodiments, only a single seal may be provided, such as the seal between the cap160and the first packaging component120.

In other alternative embodiments, various components may be omitted. For example, in some embodiments, the third packaging component124may be omitted such that the cap160is exposed to the ambient space129. In other embodiments, the third packaging component124and the cap160may both be omitted so that the exterior of the second packaging component122is exposed to the ambient space129. In such an embodiment, a seal may be formed between the first packaging component120and the second packaging component122, as described above.

In other embodiments, the cap160may be omitted, and the third packaging component124may remain. The first packaging component120and the second packaging component122may form a seal, or in some embodiments, may not form a seal. Rather, a seal may exist between the first packaging component120and the third packaging component124. In still other embodiments, particularly where the cap160and/or the third packaging component124are omitted, in place of a seal between the first packaging component120and the third packaging component124, a seal may exist between the second packaging component122and the third packaging component124, which may be shaped to come into contact with each other (for example, at the rim of the second packaging component122, proximate the first end130of the second packaging component122) to define the seal.

In some embodiments, a single-seal embodiment as described above may contain an independently sealed package, with its own membrane. For example, a single-sealed assembly (not shown) as described above may contain a blister pack or other sealed package that, in turn, contains the medical device. Thus, the medical device may be doubly-sealed from the ambient space129. In yet other alternative embodiments, a multi-sealed assembly may contain such a blister pack or other sealed package containing the medical device, providing three or more seals between the medical device and the ambient space129.

Once the packaging assembly100has been assembled with the medical device110inside, the medical device110and the packaging assembly100may be sterilized. Any known sterilization methods, such as gamma sterilization, may be used. In alternative embodiments, rather than sterilizing the packaging assembly100and the medical device110after assembly, the medical device110and the packaging assembly100may instead be sterilized prior to assembly, and assembled in a sterile environment.

The packaging assembly100and the medical device110may be used in a variety of ways. According to one way, the operator may first grip the rim156of the third packaging component124and pull the rim156away from the first packaging component120, removing the third packaging component124from the second packaging component122. If the third packaging component124is not part of the seal and is not secured to the cap160, the cap160may then be removed from the flange141, opening the seal.

Then, the operator may grip the first packaging component120with one hand, and insert the fingertips of the other hand into the second interior receptacle139of the second packaging component122to grip the first end112of the medical device110through the recess138of the second packaging component122, as shown inFIG. 4. While gripping the first end112through the recess138, the operator may pull the first end112out of the first interior space126. The operator may then insert the medical device110directly into the sterile field, avoiding the need for the user to contact the medical device110with his or her hands or gloves.

As indicated previously, packaging assemblies of a wide variety of shapes and sizes may be used.FIGS. 5A, 5B, and 5Care plan, side elevation, and perspective views of an assembly500according to one alternative embodiment. The packaging assembly500may be used to store a medical device510with an elongated (non-cylindrical) cross-sectional shape. In order to accommodate the shape of the medical device510, the packaging assembly500may have a first packaging component520, a second packaging component522, and a third packaging component524that all have a similarly elongated shape. These components may not be radially symmetrical like their counterparts of the packaging assembly100but may instead have extra length in the vertical direction ofFIG. 5Ato accommodate the shape of the medical device510.

Other shapes may be used in other alternative embodiments (not shown). For example, some assemblies may have the shape of a rectangular prism, a triangular prism, a pyramid, a cone, a frustoconical shape, and/or the like. Those of skill in the art will recognize that the packaging assembly100, the packaging assembly500, and the alternatives described above represent just a small sample of many possible assembly shapes that may be used within the scope of the present disclosure. Many other shapes may be used to store medical devices of various shapes and sizes.

In some alternative embodiments (not shown), multiple medical devices (for example, multiple sizes of a single implant or instrument type, or multiple implants and/or instruments intended to be used together) may be stored and sealed together in a single packaging assembly. Some packaging assemblies may have multiple distinct, and optionally sealed, interior spaces, each containing one or more medical devices. Such interior spaces may be independently opened to unseal and use one or more medical devices, leaving the remainder in a sealed condition. Numerous modifications may be made to suit various medical devices, procedures, and/or operating environments.