阅读说明：本技术 预装式无菌袋 (Pre-assembled aseptic bag ) 是由 B·埃尔玛纳沃伊 M·S·皮亚斯 A·阿尔特舒勒 于 2020-04-22 设计创作，主要内容包括：一种用于覆盖医疗器械的无菌袋(1200),包括：屏障部(1210)、柔性主体部(1202)和附接部(1220)。柔性主体部具有从近端延伸到远端的管状以及外表面、内表面和开口端。屏障部联接到近端,附接部形成在柔性主体部的远端处。屏障部是刚性或半刚性部件,其将无菌袋以打褶或折叠状态附接到医疗器械的无菌部件(1122)或非无菌部件(1130)。柔性主体部配置成展开在非无菌部件上,以将非无菌部件包封在柔性主体部的内表面内。非无菌部件可经由屏障部(1210)的中心开口(1211)连接到无菌部件。(A sterile bag (1200) for covering a medical instrument, comprising: a barrier portion (1210), a flexible body portion (1202), and an attachment portion (1220). The flexible body portion has a tubular shape extending from a proximal end to a distal end, and an outer surface, an inner surface, and an open end. The barrier portion is coupled to the proximal end, and the attachment portion is formed at a distal end of the flexible body portion. The barrier is a rigid or semi-rigid component that attaches the sterile bag in a pleated or folded state to a sterile component (1122) or a non-sterile component (1130) of the medical instrument. The flexible body portion is configured to be deployed over the non-sterile component to encapsulate the non-sterile component within an inner surface of the flexible body portion. The non-sterile component may be connected to the sterile component via a central opening (1211) of the barrier (1210).)

1. A sterile cover for covering a medical instrument, comprising:

a barrier portion having a central opening; and

a flexible body portion coupled to the barrier portion, the flexible body portion extending from a proximal end to a distal end and having an outer surface, an inner surface, and an open end,

wherein a barrier portion is coupled to the proximal end of the flexible body portion, the barrier portion configured to pre-load the sterile cover onto a sterile component of the medical device or to attach the sterile cover to a non-sterile component of the medical device,

wherein the flexible body portion is configured to be deployed over the non-sterile component to encapsulate the non-sterile component within an inner surface of the flexible body portion,

wherein the non-sterile component is connectable to the sterile component via the central opening of the barrier portion.

2. The sterile hood according to claim 1, wherein,

wherein the sterile cover is configured to be pre-assembled to the sterile component,

wherein the sterile cover is pre-assembled by sliding the central opening of the barrier portion onto a sterile component connection portion that mates with the non-sterile component.

3. The sterile cover of claim 1, wherein the sterile cover is configured to be temporarily attached to the non-sterile components in a pleated or folded state such that the sterile cover can be removed from the non-sterile components and replaced with a different sterile cover at any point before or after deployment of the sterile cover or at any point before or after engagement of the sterile components and the non-sterile components.

4. An aseptic closure as defined in claim 1, wherein the aseptic closure is a first aseptic closure configured to be temporarily attached to the sterile component or non-sterile component in a pleated or folded state such that the first aseptic closure can be enclosed by a second aseptic closure at any point after deployment of the first aseptic closure.

5. The sterile cover of claim 1, wherein the barrier portion is configured to be temporarily attached to a sterile component connection portion that mates with a non-sterile component such that the barrier portion can be removed and replaced without removing the flexible body portion after deployment of the sterile cover.

6. The sterile hood of claim 1, further comprising:

an attachment portion disposed at the distal end of the flexible body portion, the attachment portion configured to provide an interface for a non-sterile user to deploy the sterile cover over the non-sterile component without contacting a sterile surface and for securing the distal end of the flexible body portion after deployment to prevent contact with the non-sterile surface.

7. The sterile hood according to claim 6, wherein,

wherein the attachment portion comprises one or more pull tabs disposed about the open end of the flexible body portion at the distal end of the flexible body portion,

wherein the one or more pull tabs are configured to attach to a non-sterile surface of a medical instrument.

8. The sterile cover according to claim 1, wherein the barrier portion is a rigid or semi-rigid component having a through hole configured to fit tightly over the connection portion of the sterile component.

9. An aseptic closure as claimed in claim 8, wherein the barrier portion comprises a plurality of perforations radially surrounding the through-hole.

10. The sterile hood according to claim 8,

wherein the through hole is said central opening, having a diameter smaller than the diameter of the engaging element of the aseptic component,

wherein the barrier comprises a plurality of flexible branches radially surrounding the through hole.

11. The sterile hood according to claim 8,

wherein the through hole is said central opening, having a diameter substantially equal to a diameter of the engaging element of the aseptic component,

wherein the barrier portion comprises one or more circular cut-outs or scallops which act as a locking mechanism configured to engage with one or more keys formed in an engagement element of the sterile component.

12. The sterile hood according to claim 1, wherein,

wherein the barrier is an adhesive-backed rigid or semi-rigid member having a through-hole,

wherein the adhesive-backed rigid or semi-rigid component is configured to be temporarily attached to the distal end of the non-sterile component,

wherein the through hole is aligned with the connection portion of the aseptic component.

13. The sterile hood according to claim 1, wherein,

wherein the flexible main body part is a long tubular plastic bag, the bottom of the plastic bag is provided with holes, the holes at the bottom of the plastic bag are central openings of the barrier part,

wherein the sterile part is connected to the non-sterile part via a hole in the bottom of the plastic bag.

14. The sterile cover of claim 1, wherein the flexible body portion has a tubular shape configured to fit over the non-sterile component.

15. The sterile hood according to claim 6, wherein,

wherein the attachment portion comprises an annular structure disposed at a distal end of the flexible body portion around the open end of the flexible body portion,

wherein the annular structure has one or more apertures configured to engage a non-sterile surface of a medical instrument.

16. A sterile barrier/drape configured to be pre-assembled to sterile or non-sterile components to be mated or joined with one another, the sterile barrier comprising:

a barrier member having a central opening; and

a flexible body coupled to the barrier member, the flexible body having a hollow channel extending from a proximal end to a distal end and having an outer surface, an inner surface, and an open end,

wherein the barrier member is coupled to the proximal end of the flexible body, the central opening of the barrier member configured to couple the sterile barrier/drape to a sterile component or a non-sterile component;

wherein the flexible body is configured to enclose a non-sterile component removably connected to the sterile component via the central opening of the barrier component within an inner surface of the flexible body.

17. The sterile barrier/curtain of claim 16, wherein the sterile barrier/curtain is a first sterile barrier/curtain, is configured to be temporarily attached to a sterile component, and is configured to be removed from the sterile component and replaced with, or only replaced with, a second sterile barrier/curtain at any point before or after deployment of the barrier and mating of the sterile component and a non-sterile component.

18. The sterile barrier/curtain of claim 16, wherein the sterile barrier/curtain is configured such that the sterile components can be removed and replaced after the barrier/curtain is deployed without removing the sterile barrier/curtain.

19. The sterile barrier/curtain of claim 16, wherein the sterile barrier/curtain has a tubular opening with a proximal end and a distal end,

further comprising: a securing device on the distal end of the sterile barrier/drape for providing an interface for a non-sterile user to deploy the sterile barrier/drape without contacting the sterile surface and secure the distal end of the sterile barrier/drape after deployment to prevent contact with the non-sterile surface.

20. A method of providing a sterile barrier/drape that is pre-installed onto a sterile component of a medical device or attachable to a non-sterile component of a medical device, the method comprising:

providing a sterile barrier/drape having a barrier portion and a flexible body portion, the flexible body portion being coupled to the barrier portion; the barrier portion has a central opening, the flexible body portion has a tubular shape extending from a proximal end to a distal end, and has an outer surface, an inner surface, and an open end;

preassembling the barrier onto the sterile component by sliding the central opening of the barrier onto the connecting portion of the sterile component or by attaching the barrier to the distal end of the non-sterile component aligned with the connecting portion of the sterile component; and

the flexible body portion is deployed over the non-sterile component to encapsulate the non-sterile component within an inner surface of the flexible body portion while the sterile component is connected to the non-sterile component via the central opening of the barrier portion.

21. The method of claim 19, further comprising: after the flexible body portion is deployed on the non-sterile component, the barrier portion is removed and replaced or just replaced without removing the flexible body portion.

22. The method of claim 19, further comprising: after the flexible body portion is deployed over the non-sterile component, the barrier portion and/or the flexible body portion is removed and replaced or only replaced without disconnecting the sterile component from the non-sterile component.

Technical Field

The present disclosure relates to medical devices.

More specifically, the present disclosure illustrates a sterile bag pre-loaded onto a sterile medical device and methods of deploying and using the sterile bag during interaction of the sterile medical device and a non-sterile medical device.

Prior Art

Sterilization refers to any process that effectively renders any surface, instrument, or article free of viable microorganisms. Sterility and its maintenance as well as prevention of cross-infection are the primary factors in any key factor option in patient care. However, in practice it is not possible to prove that all organisms have been destroyed. Therefore, Sterility Assurance Level (SAL) is used as a measure of the level of microbial survival after terminal sterilization. For example, in europe, items such as medical devices can be marked as "sterile" only if the chance of remaining contaminated after sterilization is less than or equal to one part per million. Therefore, the packaging surrounding the medical devices is carefully designed to allow for sterilization of the devices, provide a microbial barrier, and effectively maintain sterility until the point of use. This type of packaging is known as a sterile barrier system. Sterile barrier systems are an important component of sterile medical devices.

In the medical field, for devices that require non-sterile and sterile components to interface with each other and enter the sterile field together, the prior art relies primarily on a removable sterile cover (e.g., a drape or bag) that acts as a barrier when deployed over the non-sterile components. Removable covers of this type are in the form of sterile drapes, blankets, or bags, which are typically rolled or pleated prior to being unrolled onto non-sterile components to minimize the chance of losing sterility. To facilitate deployment, the deployed end of the barrier includes a pull tab for the user to grasp when deploying the barrier. To facilitate attachment, an attached component or other attachment mechanism with good rigidity may anchor the barrier to the component covered by the barrier. Examples of patent publications relating to such removable sterile barriers that may be deployed over non-sterile components include U.S. patent 8459266B2 entitled "Pleated bag for interventional pullback systems" and pre-issued patent application publication US20140338676a1 entitled "Medical drape and methods for covering an instrument with a Medical drape". Other examples of sterile enclosures are disclosed in pre-grant patent application publications US20170333147a1, US20160361129a1 and US20170258544a 1.

For medical systems that require the covering of non-sterile components that interface with the sterile components and enter the sterile field with sterile bags or drapes, the bags or drapes are not pre-assembled onto the sterile components. Thus, the use of such barriers requires the user to load the sterile barrier into the sterile/non-sterile interface, deploy the bag or drape over the non-sterile components, and then load or attach the sterile disposable components to the already covered non-sterile components. This process is time consuming and prone to accidental loss of sterility when the sterile components are in contact with non-sterile users or non-sterile components.

Furthermore, the prior art lacks the ability to replace the sterile barrier without removing the disposable, sterile, disposable component from the interface where the sterile barrier contacts the non-sterile component. If there is a mechanism to prevent reuse/reattachment of the sterile components after removal and replacement of the barrier, removal and replacement of the barrier requires removal and replacement of the disposable sterile components, although sterility of the disposable components is maintained.

Furthermore, if the disposable sterile components need to be removed and/or replaced after deployment of the sterile barrier, the prior art requires removal of the sterile barrier, which further increases costs and user burden. In addition, current sterile barriers/drapes lack a means of securing the barrier aperture at the non-sterile end to prevent contact between the sterile outer surface of the barrier and the non-sterile surface prior to entering the sterile field, thereby increasing the likelihood of compromising sterility of the sterile barrier.

Thus, there is a clear need for an improved sterile barrier/curtain that can provide rapid deployment and improved sterility.

Background information

Disclosure of Invention

In accordance with at least one embodiment of the present disclosure, there is provided an apparatus comprising a sterile bag pre-loaded onto a disposable sterile component (e.g., a catheter handle) in a rolled or folded state; the pre-filled sterile bag is configured to be deployed over a non-sterile component, wherein the deployment is performed concurrently with engagement of the sterile component and the non-sterile component (e.g., the deployment of the sterile bag is performed concurrently with engagement of the catheter motor). Once deployed, the distal end of the sterile bag may be attached to the equipment cart by an attachment to minimize the possibility of contact with non-sterile surfaces or components. If the non-sterile surface of the bag is contacted by a non-sterile component, the sterile bag can be removed from the catheter handle to allow replacement.

In its simplest form, the present disclosure provides a sterile cover for covering a medical instrument, comprising: a barrier component configured to be coupled to a sterile component of a medical instrument; a flexible body coupled to the barrier component, the flexible body having a tubular shape extending from a proximal end to a distal end and having an outer surface, an inner surface, and an open end, wherein the flexible body is configured to enclose a non-sterile component connectable to the sterile component within the inner surface.

These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings and the appended claims.

Drawings

Other objects, features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying drawings which illustrate exemplary embodiments of the disclosure.

Fig. 1 illustrates an exemplary medical imaging system in which a sterile cover or bag may be applied.

Fig. 2 illustrates an exemplary embodiment of a sterile cover deployed over non-sterile components of an imaging system.

Fig. 3A, 3B, and 3C show various views of an exemplary sterile hood or bag 1200 according to embodiments of the present disclosure. Fig. 3A shows a plan view of barrier 1210, fig. 3B shows a plan view of attachment 1220, fig. 3C shows a three-dimensional view of an exemplary sterile cover or bag 1200 pre-assembled to a sterile component, with flexible body portion 1202 coupled to barrier 1210 and attachment 1220.

Fig. 4A illustrates an exemplary sterile cover or bag 1200 pre-loaded onto a sterile component, and fig. 4B illustrates an exemplary process of deploying the pre-loaded sterile cover 1200 onto a non-sterile component simultaneously with engagement of the sterile component with the non-sterile component.

Fig. 5A, 5B, 5C, 5D, 5E, and 5F each illustrate a different design of barrier portion 1210 of sterile enclosure or bag 1200, wherein the barrier portion has an opening configured to engage with connection 1152 of a sterile component.

Fig. 6A illustrates a plan view of an exemplary connection 1152, connection 1152 being configured to engage barrier 1210 of fig. 5E; fig. 6B illustrates a plan view of an exemplary connection 1152, connection 1152 being configured to engage barrier 1210 of fig. 5F.

Fig. 7A, 7B, and 7C illustrate details of an exemplary sterile cover, drape, or bag 1200 configured to be pre-assembled onto a sterile component or attached to a non-sterile component of a medical device.

Throughout the drawings, the same reference numerals and characters, unless otherwise specified, are used to designate the same features, elements, components or portions of the illustrated embodiments. Further, while the present disclosure will now be described in detail with reference to the drawings, this is done in connection with the illustrative exemplary embodiments. Changes and modifications to the described exemplary embodiments may be made without departing from the true scope and spirit of the present disclosure, which is defined by the appended claims.

When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," "coupled," or the like to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although one embodiment has been described or illustrated, features and elements so described or illustrated in one embodiment may be applicable to other embodiments. Those skilled in the art will also appreciate that references to a structure or feature being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

Detailed Description

Embodiments are based on the object of providing a sterile cover for covering a medical instrument, which comprises sterile and non-sterile components. The sterile hood includes: a barrier component configured to be coupled to a sterile component of a medical instrument; a flexible body coupled to the barrier member, the flexible body having a tubular shape extending from a proximal end to a distal end and having an outer surface, an inner surface, and an open end. The flexible body is configured to enclose within its inner surface a non-sterile component that is connectable to the sterile component.

Many medical devices require sterile components that can extend into the sterile field without the risk of contaminating the sterile field, where the sterile components interface with the non-sterile components required to operate the device. In such a case, non-sterile components may enter the sterile zone and deny the sterility of the sterile zone. A solution to prevent loss of sterility is to deploy a sterile barrier over any non-sterile components that enter the sterile field. This is particularly applicable to medical devices used in an in vivo environment where sterile components such as an interventional deployment system catheter must be interfaced with an electronic controller that cannot be sterilized.

Examples of such systems that can be deployed into the body include Optical Coherence Tomography (OCT) catheter systems, which include a catheter containing imaging optics that interface with a pullback system that can deploy the catheter and perform imaging functions. The pull back system interfaces with the computer system responsible for the digital operation of the system.

Fig. 1 shows an exemplary medical imaging system 1100. The medical imaging system 1100 includes an imaging console 1110 and a mechanically rotating optical probe 1120 (e.g., an endoscope or catheter). A Patient Interface Unit (PIU)1130 connects the optical probe 1120 to the imaging console 1110 using a cable bundle 1106. The imaging console 1110 includes a computer cart 1102 and one or more displays 1104 or the like. The optical probe 1120 may include, for example, a fiber-based catheter 1124 and a catheter handle 1122. Handle 1122 has a proximal end extending in the z-axis direction and a distal end. In an exemplary imaging procedure, imaging system console 1100 controls catheter 1124 via PIU1130 to obtain images of a target specimen (not shown), such as a cardiovascular body cavity of a patient.

The PIU1130 is the main interface between the probe 1120 and the system console 1110. The PIU1130 provides a means for rotating and linearly translating the imaging core of the catheter within the fixed outer sheath (not labeled) of the catheter. The system console 1110 and the PIU1130 are interconnected by a cable bundle 1106. The cable bundle 1106 includes a cable for transmitting power, a cable for transmitting a communication signal, and an optical fiber for illuminating light. During use of the imaging system console 1100, the entire PIU1130 is preferably covered by the sterile drape/bag 1200 and placed on a patient bed or table. The PIU1130 may provide a user interface for operating the imaging functionality of the probe from the sterile field by using the operable buttons 1131; these buttons 1131 may reflect other controls provided on a Graphical User Interface (GUI) at the imaging console 1110. The status (e.g., active, inactive, warning, etc.) of each button 1131 is communicated via an indicator LED disposed on the PIU housing; and these indicators are also reflected on the GUI of the display 1104. Thus, a user of the medical imaging system 1100 may perform the same operations from a non-sterile field using the GUI in the display 1104 or from a sterile field using the button 1131 on the PIU 1130. The PIU1130 is comprised of a beam combiner (not shown), a Fiber Optic Rotary Joint (FORJ), a motion mechanism including a rotary motor and linear stage, an electronic control board, control buttons and/or LED panel 1131, and a catheter hub 1150.

The catheter 1124 and handle 1122 to which the catheter is attached are intended to be a single use sterile component. However, the PIU1130 and the pull-back unit interfaced with the catheter (included in the PIU, but not shown) must be multi-use and non-sterile due to the costs associated with maintaining or rendering sterility prior to use or the costs associated with implementation as a disposable component. The PIU1130 and pullback unit, when attached to a catheter, must enter the sterile field to facilitate proper catheter deployment control and repositioning. Therefore, a sterile barrier must be introduced between the PIU1130 and its cable bundle 1106 and the sterile surfaces (e.g., operating table) and catheter handle in contact to avoid contaminating these sterile surfaces.

To this end, the present disclosure provides a novel sterile barrier (sterile bag or sterile hood) 1200 that extends over the non-sterile components of the device (which are required to enter the sterile field). Notably, this novel sterility barrier allows for interfacing with the sterile components of the device while meeting the need to maintain sterility in the sterile field during deployment and use of the device.

Fig. 2 illustrates an exemplary embodiment of a sterile bag 1200 deployed over non-sterile components of an imaging system 1100. In fig. 2, the proximal and distal pouch ends are shown in the deployment direction. As shown in fig. 2, sterile bag 1200 includes flexible body portion 1202, barrier portion 1210, and attachment portion 1220. The flexible body portion 1202 has a tubular shape extending from a proximal end to a distal end, and has an outer surface, an inner surface, and an open end. The term "tubular" as used herein means: the flexible body portion 1202 is any sterile cover structure having a hollow opening through the center, forming a tube, and can have many different sizes and shapes. For example, in some embodiments the flexible body portion 1202 may have a long, narrow tubular shape, while in other embodiments the flexible body portion 1202 may have a short, wide tubular shape. Further, the term "tubular" does not necessarily limit the flexible body portion 1202 to a tubular shape having a circular cross-section. In the present disclosure, the flexible body portion 1202 may have a generally cylindrical tubular shape, as in the example shown in fig. 2. In other embodiments, the tubular shape of the flexible body portion 1202 may have a rectangular cross-section, thereby having a rectangular tubular shape. In further embodiments, the flexible body portion 1202 may have an irregular tubular shape; or the flexible body portion 1202 may be unfolded into a flat sheet, rolled up at one end to form the outer edge of the barrier portion 1210, and the other end (attachment portion 1220) glued onto the surface of the computer cart 1102. In fig. 2, the flexible body portion 1202 is shown as a tube for ease of illustration, but it is not limited to being tubular. Indeed, to facilitate manipulation and engagement/disengagement of sterile and non-sterile components, the flexible body portion 1202 may take any shape to even conform to the shape of the covered medical instrument. In terms of materials, the flexible body portion 1202 may be made of any suitable flexible material, including fabrics and/or plastic materials commonly used for conventional medical drapes.

Barrier 1210 includes an outer edge 1212 and a channel 1211 (central opening or through hole). Attachment portion 1220 includes one or more attachment members, such as attachment tab 1221 having through-hole 1222. In the deployed state, the flexible body portion 1202 of the sterile bag (or sterile enclosure) 1200 has a substantially tubular shape configured to enclose non-sterile components therein, which in this embodiment include at least the PIU1130 and the cable bundle 1106.

In one embodiment, to reduce the likelihood of contact between sterile bag 1200 and a non-sterile surface during or after deployment, attachment portion 1220 may include two or more pull tabs 1221, each pull tab 1221 having a small diameter through-hole 1221. Additionally, a small hook 1223 for each pull tab 1221 may also be installed around the interface between the non-sterile cable bundle 1106 and the body of the computer cart 1102. The sterile bag 1200 may be held by hooks 1223 when deployed by a non-sterile user to avoid contact between the sterile surface of the bag and the user. When fully deployed, pull tab 1221 may be attached to hook 1223 on the body of computer cart 1102, thereby temporarily holding the barrier in place while repositioning non-sterile components (e.g., PIU 1130). Thus, the likelihood of the outer surface of the sterile bag coming into contact with non-sterile surfaces outside the sterile field is reduced. Fig. 2 shows the complete device with sterile bag 1200 unfolded and attached to hook 1223, reducing the possibility of contact between barrier 1210 and non-sterile components (PIU1130, cable bundle 1106).

Conventionally, the process of unfolding the sterile bag over non-sterile components (e.g., PIU1130, cables, etc.) is slow because the sterile bag is provided as a separate package and must be unfolded over the PIU before the conduit 1124 is engaged with the PIU. During this process, if the sterile bag comes into contact with non-sterile components, surfaces, or users, the sterile bag may lose sterility even before entering the sterile field.

In accordance with the present disclosure, the sterile bag is configured to be pre-loaded onto the disposable catheter handle 1122 in a compact (rolled or pleated) state. In this manner, deployment of the sterile bag can occur simultaneously (concurrently) with the catheter engaging the PIU during deployment. To this end, the sterile bag 1200 disclosed herein utilizes specially designed components (portions) to allow the sterile bag to remain compactly attached to the catheter handle prior to deployment and to be quickly deployable during engagement of the catheter with the motor.

Fig. 3A and 3B illustrate exemplary embodiments of attachment portion 1220 and barrier portion 1210 of sterile bag 1200. As shown in fig. 2, the flexible body portion 1202 of the sterile bag 1200 has a proximal end and a distal end. At the proximal end, the flexible body portion 1202 terminates or is attached to the barrier portion 1210. At the distal end, the flexible body portion 1202 terminates in an attachment portion 1220. Fig. 3A shows an exemplary embodiment of barrier 1210 viewed along the z-axis. Barrier 1210 has or forms an opening 1211 having a diameter D1 sized to fit over connection 1152 (the engagement element) of catheter handle 1122. Connecting portion 1152 (the engagement element) of catheter handle 1122 has a diameter "D" (D ≈ D1) of substantially the same size as diameter D1. Fig. 3B shows an exemplary embodiment of the attachment portion 1220, also viewed in the z-axis direction. Attachment portion 1220 includes one or more (two in the embodiment of fig. 3B) attachment tabs 1221, each having a through hole 1222. The attachment portion 1220 having an annular shape has or forms an opening 1225 with a diameter D2 (greater than D1) sized to allow non-sterile components (e.g., the PIU1130 and cable bundle 1106) to pass through.

Here, "loop" attachment 1220 is an alternative or alternative embodiment for attaching a sterile bag or drape to the system. As noted above with respect to fig. 2 and mentioned elsewhere in this disclosure, sterile bag 1200 includes attachment portion 1220 (attachment member) of any shape or structure to allow the distal end of the bag to be securely attached to a fixed surface of the system. To this end, any other attachment structure may be used (e.g., such asSuch as an adhesive) attaches the distal end of the sterile bag 1200 to a non-sterile surface (e.g., a surface of the computer cart 1102). The attachment means may comprise other attachment structures that may be attached and removed in any suitable manner, such as fasteners, clasps, snaps, zippers, or any other suitable mechanism.

The attachment portion 1220 (attachment member) having a ring shape may be made of a rigid polymer, such as nylon; it may be cut from a sheet of semi-rigid polyester (Mylar), or it may even be made from sterilized cardboard or the like. Alternatively, the loop attachment 1220 may simply be the open end of a sterile plastic bag. For example, in one embodiment, the simplest implementation of the sterile bag 1200 or sterile hood can be just a long plastic bag with a hole punched in the bottom of the bag through which the connection between the PIU and the catheter handle can be made. In this case, the open end of the plastic bag may be reinforced with a rigid or semi-rigid material to form a ring-shaped member around the edge of the bag, and the reinforced edge may be attached to the computer cart of the system. In another alternative, the open end of the plastic bag may have one hole or more than one hole punched around the edge of the bag so that the bag may be attached directly to some structure of the system computer cart.

Fig. 3C shows (for ease of illustration) the sterile bag 1200 in a pre-deployment state, wherein the flexible body portion 1202 of the sterile bag 1200 is rolled or crumpled or folded or pleated to remain compact prior to deployment.

In fig. 3C, when the sterile bag 1200 is preloaded onto the proximal end of the catheter handle 1122, the opening 1211 of the barrier 1210 slides over the connection 1152 of the catheter handle 1122 while pulling the attachment portion 1220 and flexible body portion 1202 in the z-axis direction (toward the distal end of the catheter handle). The opening 1211 slides over the connection 1152 until the barrier 1210 abuts the flange 1122a of the catheter handle 1122. To maintain the sterility of the catheter handle 1122 and sterile bag 1200, at least a portion of the inner surface 1202a of the flexible body portion 1202 is exposed outwardly during pre-assembly. Then, after pre-loading the sterile bag onto catheter handle 1122, flexible body portion 1202, barrier portion 1210, and attachment portion 1220 are rolled or creased or folded or pleated to remain compact prior to deployment. In other embodiments, the sterile bag 1200 may be expanded onto a non-sterile device without pre-assembly onto a sterile device.

Fig. 4A and 4B illustrate an exemplary process of concurrently deploying a pre-filled sterile bag 1200 over non-sterile components while the catheter is engaged to the PIU. Preloading of the sterile bag 1200 onto the sterile components of the system in accordance with the present disclosure provides significant advantages in terms of usability such that any necessary splicing procedures between the two components, manifested as electrical, mechanical, optical, etc., can occur in parallel with deployment of the sterile bag 1200 onto the non-sterile components (e.g., the PIU1130 and the cable bundle 1106) as the mating process between the sterile and non-sterile components proceeds. Considering that the engagement procedure can take several seconds, pre-assembling the sterile bag on the sterile component eliminates any additional time required to first unfold the non-pre-assembled bag on the non-sterile component and then time-mate and engage the sterile and non-sterile components.

Fig. 4A shows a pre-deployment state, in which the sterile bag 1200 is pre-loaded at the proximal end of the catheter handle 1122. The general pre-deployment configuration shown in fig. 4A is characterized by the sterile bag 1200 being comprised of a rigid or semi-rigid component (barrier 1210) having a circular surface containing through-holes 1211 to allow passage of the engagement elements (connections 1152) of the sterile component (catheter handle 1122) responsible for mating with the non-sterile component (PIU 1130). The rigid or semi-rigid component (barrier 1210) is attached to the flexible body portion 1202, the flexible body portion 1202 forming a majority of the surface area of the sterile bag 1200, and the sterile bag 1200 is pleated or folded such that the flexible body surface 1202a, which will contact the surface of the non-sterile component when unfolded, faces outward before unfolding, and the outward sterile surface 1202b faces inward, maintaining sterility before unfolding. The semi-rigidity of barrier portion 1210 in engagement with the engagement element (connection 1152) of the sterile component allows for compression of barrier portion 1210 prior to removal of the sterile component and pre-filled bag from the package while still maintaining the integrity of the connection of the sterile bag to the engagement element prior to and during deployment. The flexible body portion 1202 of the sterile bag 1200 may be rolled or pleated or crumpled or folded such that the inner surface 1202a faces outward (see fig. 3C) prior to being unfolded to minimize the likelihood of contact between the outer surface 1202b and other non-sterile surfaces that need to be maintained sterile.

Fig. 4B shows the unfolded state of the sterile bag 1200. Sterile bag 1200 may be positioned on engagement element (1152) of sterile component (1122) prior to pre-loading and deployment. This is suggested to facilitate minimizing interference with the sterile component handling after the sterile bag 1200 is unfolded onto the non-sterile component 1130. In particular, to facilitate unrolling over the non-sterile components and securing the semi-rigid components of the sterile barrier between the non-sterile components and the sterile components after mating and engagement, it is advantageous to pre-load sterile bag 1200 onto engagement element (1152) of sterile component (1122).

In the event that the sterility of the sterile bag 1200 is compromised, such as where the bag 1200 may lose sterility through contact with non-sterile surfaces after deployment or where the flexible body portion 1202 may be punctured, cut, etc., it is proposed that the sterile bag 1200 disclosed herein may be easily removed and replaced, or simply replaced. This process may be performed before or after mating of the sterile and non-sterile components. In the case of removal and replacement of the sterile bag prior to mating of the components and unfolding of the bag, removal of the folded/pleated sterile barrier from the engagement element (1152) simply involves disengaging the mechanism (such as one of those shown in fig. 3C) that temporarily attaches it to the element and using the same mechanism to attach a new folded/pleated sterile barrier. In the case of mating and post-splicing replacement of the sterile barrier, the barrier may be removed before or after deployment by one of the aforementioned splicing element mechanisms without removing the sterile component, and a new folded/pleated sterile barrier may be placed over the sterile component and attached by the same mechanism. Further, if the integrity of the barrier to be replaced permits, a new barrier or sterile bag 1200 can simply be attached and unfolded over the previous barrier or sterile bag without removing the other barrier or sterile bag. This mechanism allows barrier or bag 1200 to be replaced without the need to remove or replace sterile components, providing significant time and cost advantages over permanently attached barriers.

In the event that the sterile components are compromised, such as where the engagement mechanism may fail or the sterility of the sterile components is compromised, if the sterile barrier or bag 1200 has been deployed over a non-sterile component, the bag or barrier may remain deployed, removed from the sterile component, and attached to a new sterile component, which is then mated and engaged with the non-sterile component. This mechanism allows sterile components to be replaced without having to replace sterile barrier or bag 1200 that has already been deployed over non-sterile components, providing a significant time advantage over a permanently attached barrier and requiring the barrier to be re-deployed when sterile components need to be replaced.

As described above, the manner in which the sterile bag 1200 is preloaded onto the catheter handle 1122 is not limited to the use of a rigid or semi-rigid barrier 1210. The present disclosure also utilizes several other configurations to attach the rigid or semi-rigid barrier 1210 to the engagement element (1152) of the catheter handle. The basic construction may be characterized in that the semi-rigid barrier member (barrier 1210) described previously has a through hole 1211, the diameter D1 of the through hole 1211 being slightly smaller than the diameter of the engagement element (1152). This allows the barrier 1210 to be held in place using the spring force and friction of the barrier member. However, other structures and configurations may be used for barrier 1210, as shown in fig. 5A-5F.

Fig. 5A shows an embodiment of barrier 1210 as a separate barrier component made of a semi-rigid material having a through hole with a diameter D1, as described above with reference to fig. 3A. Fig. 5B shows another embodiment of a barrier 1210 as a barrier component made of a rigid material (having a higher stiffness than the barrier component of fig. 5A). The barrier component of fig. 5B includes a plurality of perforations "p" for providing some flexibility or resiliency to the rigid material. In fig. 5B, barrier 1210 has an internal opening or through-hole 1211 that is slightly smaller in diameter than the engaging element (1152) but has a higher stiffness at the sides, allowing for higher resistance during pre-assembly and easier translation of the flexible body portion in the deployment direction.

Fig. 5C shows another embodiment of barrier 1210, having a "garland" concept, relying on a ring with a diameter D1 smaller than the diameter of the junction element (1152), but with 3 branches 1213 with a radius larger than the junction element radius. Fig. 5D shows the "garland" concept, relying on a ring with a diameter D1 smaller than the diameter of the engagement element (1152), but with 4 branches 1213 with a radius larger than the engagement element radius. In fig. 5C and 5D, barrier 1210 has a through hole with a smaller diameter than engaging element (1152), but the material has higher rigidity. In this case, the multiple branches of the garland are flexible, allowing easier translation in the direction of pre-installation of the bag (see fig. 3C) and more difficult translation in the direction of deployment of the bag onto the non-sterile components (see fig. 4B).

Fig. 5E and 5F illustrate another embodiment of barrier 1210, shown as a rigid barrier member having a slotted hole or central opening 1211, with a circular cutout (cut-away sector) configured for engagement with a sector protrusion or key 1153 of an engagement element (connector 1152) of a sterile member. These circular cutouts (or cut out sectors) around the through-hole 1211 serve as the locking mechanism 1215. The barrier member 1210 shown in fig. 5E and 5F is configured to mate with an engagement element (1152) having a key 1153 (shown in fig. 6A and 6B). In this embodiment, the rigid barrier member 1210 is first aligned with the key 1153 to match the cut out sector 1215 to the key 1153, and then rotated in the direction R to mismatch the cut out sector with the orientation of the key 1153 on the engagement element (1152) to lock the sterile bag (attached to the barrier member) in place.

Barrier member 1210 may be made of a rigid polymer (e.g., nylon), stamped from a thin semi-rigid polyester sheet, or even sterilized cardboard, among others. Alternatively, it may simply punch a hole in the closed proximal end of the tubular body around which it is attached by glue to a rigid flange integral with the catheter handle. In the latter case, the flange may be removed with the handle, but the tubular body may be left on the PIU if desired. For example, in one embodiment, the simplest implementation of a sterile bag or cover may be just a long plastic bag with a hole punched into the bottom of the bag through which the connection between the PIU and the catheter handle is made. As described above, the holes punched in the bag may be reinforced with a rigid or semi-rigid material to form the barrier member, and the bag may be attached to the catheter handle flange with temporary glue and removed when needed. In other embodiments, a plastic bag with holes punched in the bottom may be attached directly to the flange 1122a of the catheter handle 1122. In this case, barrier member 1210 has no physical outer edges because it is simply the bottom of the tubular bag glued to flange 1122 a.

In accordance with the present disclosure, by pre-assembling sterile bag 1200 to catheter handle 1122 (the sterile component), such that the non-sterile surface of the flexible body of the bag faces outward prior to deployment, and allowing the drape deployment to proceed simultaneously with the mating of the non-sterile and sterile components of the device, a reduction in the time required to completely prepare the device for use is achieved. Furthermore, the method of attaching the barrier component to the sterile component allows for rapid removal and replacement of the sterile bag or deployment of another sterile bag over an already deployed bag without the need to remove sterile components already connected to non-sterile components in the event that sterility of the outer surface of the sterile bag is compromised. This advantageously reduces the time and cost associated with replacing a damaged sterile bag or replacing a sterile component. Further, the sterile components of the device can be replaced without replacing the sterile barrier, and the barrier can remain unfolded while the sterile components are replaced if the barrier has been unfolded over non-sterile components of the device, which also reduces the time and burden required to remove and re-unfold the sterile bag if it is permanently attached to the sterile components.

Another advantage is the provision of an attachment tab at the distal end of the sterile bag, allowing for non-tamperingThe sterility of the pouches is easily deployable by non-sterile users, and also provides a means of attaching the sterile barrier to a surface so as to avoid contact between the exterior sterile surface and the non-sterile surface before bringing the barrier into the sterile zone. In this regard, although it has been described that the attachment member is an attachable tab having a through hole that engages with a hook, the attachment member is not limited to tabs and corresponding hooks. Any other attachment structure may be employed (e.g., such asSuch as an adhesive) attaches the distal end of the sterile bag 1200 to a non-sterile surface (e.g., a surface of the computer cart 1102). The attachment means may comprise other attachment structures that may be attached and removed in any suitable manner, such as fasteners, clasps, snaps, zippers, or any other suitable mechanism.

The material of the sterile cover should be selected to provide a sufficient barrier to prevent penetration contamination. Therefore, nonwoven polymer films (e.g., polyethylene, polyvinyl chloride, polyurethane, polystyrene, polycarbonate, acrylic, silicone rubber, polypropylene, synthetic rubber, etc.) are typically employed, preferably transparent for ease of use. Furthermore, the materials selected should be able to withstand the sterilization method selected for the sterile component. For example, for sterile parts that contain plastic and require ethylene oxide (EtO) sterilization processes, 2 mil thick polyethylene films and 10 mil thick polyester semi-rigid barrier parts may be used.

Embodiments of the present disclosure may be modified and/or combined with each other. In addition, it will be understood that various modifications may be made without departing from the scope of the disclosed embodiments.

In the present disclosure, preloading the sterile barrier onto the sterile components of the medical device system provides a significant advantage in terms of usability, such that any necessary engagement procedures between the two components, manifested as electrical, mechanical or optical procedures, etc., can be performed simultaneously with deploying the sterile barrier onto the non-sterile components as the mating process between the sterile and non-sterile components is performed. Considering that the engagement procedure can take several seconds, pre-assembling the barrier to the sterile component eliminates any additional time required to first deploy the non-pre-assembled barrier on the non-sterile component and then time-mate and engage the sterile and non-sterile components. The pre-deployment general configuration shown in fig. 4A is characterized by the sterility barrier comprising a barrier member in the shape of a semi-rigid circular surface containing a through-hole (central opening) to allow passage of an engagement element (connection 1152) of the sterility member (catheter handle 1122) responsible for mating with a non-sterility member. Semi-rigid barrier component 1210 is attached to flexible body portion 1202 that constitutes the majority of the surface area of sterile barrier or bag 1200, which is pleated or folded such that flexible body surface 1202a, which would be in contact with non-sterile component surfaces when unfolded, is facing outward when prior to unfolding, while the outward sterile surface 1202b of the flexible body is facing inward, thereby maintaining sterility prior to unfolding. The semi-rigidity of the barrier member allows for interfacing with an engagement element (1152) of the sterile member and for pressing the flexible body against the barrier member prior to removal of the sterile member and pre-assembled barrier from the package while still maintaining the integrity of the connection of the sterile barrier to the engagement element prior to and during deployment. The barrier may be rolled/pleated so that the inner surface faces outward prior to unrolling to minimize the likelihood of contact between the outer surface, which needs to be kept sterile, and other non-sterile surfaces. The barrier prior to deployment may be positioned on the engagement elements of the sterile components in order to minimize interference with the handling of the sterile components after deployment, ease of deployment on the non-sterile components, and secure the semi-rigid components of the sterile barrier between the non-sterile components and the sterile components after mating and engagement.

According to another embodiment, sterile bag 1200 is not pre-assembled on sterile components, but rather may be deployed directly on non-sterile components while (or just prior to) being engaged with non-sterile components that have been covered by a sterile barrier, drape, or bag 1200. Fig. 7A, 7B, and 7C show details of an exemplary sterile cover, drape, or bag 1200. Fig. 7A shows a perspective view of a sterile cover, drape, or bag 1200 in a pre-filled and pre-deployed state. Sterile bag 1200 has a tubular flexible body portion 1202, a barrier portion 1210, and an attachment portion 1220. In the pre-installed state, at least a portion of the non-sterile interior surface 1202a of the bag 1200 is exposed. According to the embodiment shown in fig. 7A-7C, in the pre-assembled state, the flexible body portion 1202 is rolled or creased or folded or pleated (see detail a) to remain compact prior to deployment. Fig. 7B shows detail a of fig. 7A as one example of a way to fold bag 1200 prior to loading and unfolding the bag. Specifically, prior to deployment, the sealed end (barrier side) and the open end (attachment side) are substantially in the same plane, and the body portion 1202 is folded into a plurality of z-folded layers to form a compact package. Fig. 7C shows the unfolded state of the sterile bag 1200. To facilitate easy deployment by a non-sterile user, one or more pull tabs 1221 are provided around the open end of the body portion 1202. The pull tab 1221 is attached to the non-sterile inner surface 1202a by an adhesive 1227 (e.g., a medical device adhesive or curable material).

In the embodiment shown in fig. 7A-7C, the barrier 1210 has an opening 1211 and a semi-rigid ring (see fig. 3A) backed adhesive intended to provide a means to temporarily attach the bag 1200 to the edge or distal end of the PIU1130 (see fig. 1-2) prior to deployment. Of course, as described in the previous embodiments, the adhesive backed semi-rigid ring of the barrier 1210 may also provide a means to pre-load and temporarily attach the bag 1200 to the proximal end of the catheter handle 1122 prior to deployment. The curtain or bag 1200 is pleated in a z-fold fashion prior to deployment, with the inner surface 1202a of the curtain facing outward prior to deployment. A pull tab 1221 with optional aperture 1222 is attached to the curtain pleated inner surface 1202a proximal to the semi-rigid ring prior to curtain deployment. The way the bag is pulled and unfolded with the pull tab 1221 is as follows: the drape is deployed towards the proximal end of the PIU by placing the bag over the most distal non-sterile component (primarily the PIU1130), adhering the interior of the loop to the catheter handle or PIU rim and aligning the opening 1211 around the catheter insertion point, and then by pulling the pull tab 1221 in the deployment direction (see fig. 7C). Similar to the previous embodiments, diameter D1 of opening 1211 is approximately equal to diameter "D" of connection 1152 or the sterile component (catheter handle 1122). When fully deployed, the drape or bag 1200 will fully contain the non-sterile components of the PIU into the non-sterile area and the position will be maintained and not cover the catheter insertion point on the catheter handle or PIU due to the adhesion provided by the semi-rigid ring adhesive or by the lock provided at the PLU/catheter handle junction. In addition, to secure the unfolded sterile barrier or bag 1200 to non-sterile components, the pull tab 1221 may be tied, adhered, attached, or otherwise secured to the proximal end of the PIU or some structure of the console 1110.

In the embodiment of fig. 7A-7C, similar to the embodiment of fig. 4A-4B, the sterile bag 1200 may be easily removed and replaced, or simply replaced, before or after mating of the sterile and non-sterile components in the event that the sterility of the sterile bag 1200 is compromised, such as if the bag 1200 loses sterility by contact with non-sterile surfaces after deployment or if the flexible body portion 1202 is punctured, cut, etc. In the case of removal and replacement of the sterile bag 1200 prior to mating of the components, removal of the folded/pleated sterile bag 1200 from the PIU distal end involves detaching the adhesive backed semi-rigid ring 1210 from the catheter handle or PIU and attaching a new folded/pleated sterile bag 1200 using the same mechanism. In the event that the compromised sterile barrier is replaced after the sterile and non-sterile components have been mated and joined, the compromised sterile bag 1200 may be left in place and a new folded/pleated sterile barrier may be slipped on and attached by the same procedure. That is, if the integrity of a new sterile barrier or bag 1200 can be maintained, this new barrier or sterile bag 1200 can simply be attached and unfolded over the previous barrier or sterile bag without removing the other compromised barrier. Such a mechanism allows replacement of the barrier or bag 1200 without the need to remove or replace sterile components, providing a significant time saving advantage over permanently attached barriers.

An advantage of the sterile barrier disclosed herein is that it provides for pre-assembling the sterile barrier to the sterile component through the use of a rigid or semi-rigid barrier component. In this manner, the non-sterile surface of the barrier can be pre-loaded in an outward manner prior to barrier deployment and allows barrier deployment to occur simultaneously with the mating of the non-sterile and sterile components of the device during barrier deployment, reducing the time required to fully prime the device for use. Furthermore, the method for attaching the barrier to the sterile component allows for the removal and replacement of the sterile barrier or the deployment of another barrier over the barrier already in place, thereby eliminating the need to remove the sterile component of the device in the event that the sterility of the outer surface of the barrier is compromised, reducing the time and cost associated with requiring replacement of the sterile component to replace the barrier. Furthermore, the sterile components of the device can be replaced without the need to replace the sterile barrier, and the barrier, if already deployed on non-sterile components of the device, can keep the barrier deployed while the sterile components are replaced, which also reduces the time burden required to remove and re-deploy the sterile barrier if permanently attached to the sterile components.

Another advantage of providing pull tab 1221 at the distal end of sterile barrier or bag 1200 is that it allows the sterile barrier to be easily deployed by a non-sterile user without compromising the sterility of the barrier, and also provides a means of attaching the barrier to a surface to avoid contact between outer sterile surface 1202b and non-sterile components prior to bringing barrier or bag 1200 into the sterile field.

In the description, specific details are set forth in order to provide a thorough understanding of the disclosed examples. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure the present disclosure. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The scope of the invention is not limited by the subject specification, but only by the plain meaning of the claim terms employed. The term "sterile" as used herein refers to its usual medical definition, meaning completely clean and substantially free of bacteria or other living microorganisms. Similarly, the terms "non-sterile" and "non-sterile" are used interchangeably to mean not free of living organisms and microorganisms, as is the case with medical procedures performed in non-sterile medical instruments or in non-sterile environments.

It will be understood that if an element or portion is referred to herein as being "on …," "against," "connected to," or "coupled to" another element or portion, it can be directly on …, against, connected to, or coupled to the other element or portion, or intervening elements or portions may be present. In contrast, if an element is referred to as being "directly on" …, "directly connected to" or "directly coupled to" another element or portion, there are no intervening elements or portions present. The term "and/or" when used may be abbreviated as "/", and includes any and all combinations of one or more of the associated listed items, if provided.

Spatially relative terms, such as "below …," "below …," "below …," "lower," "above …," "upper," "proximal," "distal," and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature, as illustrated in the figures. It will be understood, however, that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, spatially relative terms such as "below …" may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, where applicable, the terms "proximal" and "distal" with respect to space may also be interchanged.

The term "about" or "approximately" as used herein means, for example, within 10%, within 5%, or less. In some embodiments, the term "about" may mean within measurement error. In this regard, where described or claimed, all numbers may be understood to begin with the word "about" or "approximately" even if the term does not expressly appear. The phrases "about" or "approximately" when describing a size and/or position may be used to indicate that the value and/or position being described is within a reasonable expected range of values and/or positions. For example, a numerical value can have a value within +/-0.1% of the value (or range of values) listed, +/-1% of the value (or range of values) listed, +/-2% of the value (or range of values) listed, +/-5% of the value (or range of values) listed, +/-10% of the value (or range of values) listed, and the like. Any numerical range (if mentioned herein) is intended to include all sub-ranges subsumed therein.

The terms first, second, third, etc. may be used herein to describe various elements, components, regions, sections and/or regions. It will be understood that these elements, components, regions, sections and/or regions should not be limited by these terms. These terms are only used to distinguish one element, component, region, section or section from another region, region or section. Thus, a first element, component, region, section or section discussed below could be termed a second element, component, region, section or section without departing from the teachings herein.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, components, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, components, steps, operations, elements, components, and/or groups thereof that are not expressly listed. It should also be noted that some claims may be drafted to exclude any optional element; such claims may use the exclusive term "only," "only," or the like in connection with the recitation of claim elements, or may use a "negative" limitation.

In describing the example embodiments illustrated in the drawings, specific terminology is employed for the sake of clarity. However, the disclosure of this patent specification is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner.

While the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the disclosure is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.