Prefilled sterile bags

Abstract

A sterile bag (1200) for covering a medical device comprises: a barrier portion (1210), a flexible main body portion (1202) and an attachment portion (1220). The flexible main 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 connected to the proximal end, and the attachment portion is formed at the distal end of the flexible main body portion. The barrier portion is a rigid or semi-rigid component that attaches the sterile bag to a sterile component (1122) or a non-sterile component (1130) of the medical device in a pleated or folded state. The flexible main body portion is configured to unfold on the non-sterile component to enclose the non-sterile component within the inner surface of the flexible main body portion. The non-sterile component can be connected to the sterile component via a central opening (1211) of the barrier portion (1210).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Application No. 16 / 854,366, filed on April 21, 2020, which claims priority to Provisional Application No. 62 / 840,932, filed on April 30, 2019, the disclosures of which are incorporated herein by reference in their entireties.

[0003] Background Information Technical Field

[0004] The present disclosure relates to medical devices.

[0005] More specifically, the present disclosure exemplifies sterile bags pre-loaded on sterile medical devices and methods of deploying and using the sterile bags during interaction between the sterile medical devices and non-sterile medical devices. Prior art

[0006] Sterilization is any process that effectively renders any surface, device or article free of viable microorganisms. Sterility and its maintenance, as well as the prevention of cross infection, are paramount in any critical factor selection in patient care. However, in practice it is impossible to prove that all organisms have been destroyed. Therefore, the 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 only be labeled "sterile" if the probability of contamination after sterilization is less than or equal to one in a million. Therefore, the packaging surrounding medical devices is carefully designed to allow these devices to be sterilized, provide a microbial barrier, and effectively maintain sterility until the point of use. This type of packaging is called a sterile barrier system. Sterile barrier systems are an important component of sterile medical devices.

[0007] 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 mainly relies on removable sterile covers (e.g., drapes or bags) that act as a barrier when deployed over the non-sterile components. This type of removable cover is in the form of a sterile drape, blanket, or bag that is usually rolled or pleated before being deployed over the non-sterile component 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 with good rigidity or other attachment mechanism can anchor the barrier to the component covered by the barrier. Patent disclosure examples related to such removable sterile barriers that can be deployed on non-sterile components include U.S. Patent No. 8,459,266B2 entitled "Pleated bag for interventional pullback systems" and pre-grant patent application publication US20140338676A1 entitled "Medical drape and methods of covering equipment with medical drapes". Other examples of sterile covers are disclosed in pre-grant patent application publications US20170333147A1, US20160361129A1, and US20170258544A1.

[0008] For medical systems that require a sterile bag or drape to cover a non-sterile component that interfaces with a sterile component and enters a sterile field, the bag or drape is not pre-installed on the sterile component. Therefore, the use of such a barrier requires the user to attach the sterile barrier to the sterile / non-sterile interface, unfold the bag or drape over the non-sterile component, and then load or connect the sterile disposable component to the already covered non-sterile component. This process is time consuming and prone to accidental loss of sterility when the sterile component comes into contact with a non-sterile user or non-sterile component.

[0009] Furthermore, in the case where the sterile barrier contacts non-sterile components, the prior art lacks the ability to replace the sterile barrier without removing the disposable, sterile, disposable components from the interface. If there is a mechanism to prevent the sterile components from being reused / reattached after the barrier is removed and replaced, although the sterility of the disposable components is maintained, the removal and replacement of the barrier also requires the removal and replacement of the disposable sterile components.

[0010] Furthermore, if the disposable sterile components need to be removed and / or replaced after the sterile barrier is deployed, the prior art requires removal of the sterile barrier, further increasing costs and user burden. Additionally, current sterile barriers / drapes lack a method of securing the barrier apertures at the non-sterile end to prevent the sterile outer surface of the barrier from contacting the non-sterile surface prior to entering the sterile field, thereby increasing the potential for compromising the sterility of the sterile barrier.

[0011] Therefore, there is a clear need for improved sterile barriers / drapes that can provide rapid deployment and improved sterility. Summary of the invention

[0012] According to at least one embodiment of the present disclosure, a device is provided, which includes a sterile bag preloaded onto a disposable sterile component (e.g., a catheter handle) in a rolled or folded state; the preloaded sterile bag is configured to be unfolded on a non-sterile component, wherein the unfolding process is performed simultaneously with the engagement of the sterile component and the non-sterile component (e.g., the sterile bag unfolding is performed simultaneously with the engagement of the catheter motor). Once unfolded, the distal end of the sterile bag can be attached to an equipment cart via 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.

[0013] In its simplest form, the present disclosure provides a sterile cover for covering a medical device, comprising: a barrier component configured to be connected to a sterile component of the medical device; a flexible body connected 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 that can be connected to the sterile component within the inner surface.

[0014] These and other objects, features and advantages of the present disclosure will become apparent from a reading of the following detailed description of exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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 present disclosure.

[0016] Figure 1 An exemplary medical imaging system is shown in which a sterile drape or bag may be applied.

[0017] Figure 2 An exemplary embodiment of a sterile drape deployed over non-sterile components of an imaging system is shown.

[0018] Figure 3A , Figure 3B and Figure 3CVarious views of an exemplary sterile cover or bag 1200 are shown in accordance with an embodiment of the present disclosure. Figure 3A A plan view of the barrier portion 1210 is shown, Figure 3B A plan view of the attachment portion 1220 is shown, Figure 3C A three-dimensional view of an exemplary sterile cover or bag 1200 pre-assembled onto a sterile component is shown with a flexible body portion 1202 coupled to a barrier portion 1210 and an attachment portion 1220 .

[0019] Figure 4A An exemplary sterile cover or bag 1200 is shown pre-installed on sterile components. Figure 4B An exemplary process of deploying a pre-installed sterile cover 1200 over a non-sterile component simultaneously with engagement of the sterile component with the non-sterile component is shown.

[0020] Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5F Each shows a different design of a barrier portion 1210 of a sterile cover or bag 1200, wherein the barrier portion has an opening configured to engage with a connection portion 1152 of a sterile component.

[0021] Fig. 6A A plan view of an exemplary connection portion 1152 is shown, and the connection portion 1152 is configured to Figure 5E The barrier portion 1210 is engaged; Figure 6B A plan view of an exemplary connection portion 1152 is shown, and the connection portion 1152 is configured to Fig. 5F The barrier portion 1210 is engaged.

[0022] Fig. 7A , Figure 7B and Figure 7C Details of an exemplary sterile cover, drape or bag 1200 are shown that is configured to be pre-installed onto a sterile component or attached to a non-sterile component of a medical device.

[0023] In all drawings, unless otherwise indicated, the same reference numerals and characters are used to represent the same features, elements, components or parts of the illustrated embodiments. In addition, although the present disclosure will now be described in detail with reference to the accompanying drawings, this is done in conjunction with illustrative exemplary embodiments. Changes and modifications may be made to the described exemplary embodiments without departing from the true scope and spirit of the present disclosure as defined by the appended claims.

[0024] When a feature or element is mentioned as "on" another feature or element in this article, it can be directly on another feature or element, or there can also be intermediate features and / or elements. On the contrary, when a feature or element is mentioned as "directly on" another feature or element, there is no intermediate feature or element. It will also be understood that when a feature or element is mentioned as "connected", "attached", "coupled", etc. to another feature or element, it can be directly connected, attached or coupled to another feature or element or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although an embodiment has been described or shown, the features and elements so described or shown in one embodiment can be applicable to other embodiments. It will also be understood by those skilled in the art that when a structure or feature is mentioned to be "adjacent" to another feature, there can be a part overlapping or located under the adjacent feature with the adjacent feature. DETAILED DESCRIPTION

[0025] The purpose on which the embodiments are based is to provide a sterile cover for covering a medical device, the medical device comprising a sterile component and a non-sterile component. The sterile cover comprises: a barrier component configured to be coupled to the sterile component of the medical device; 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. The flexible body is configured to enclose a non-sterile component that can be connected to the sterile component within its inner surface.

[0026] Many medical devices require sterile components that can be extended into the sterile field without risk of contaminating the sterile field, where the sterile components interface with non-sterile components required to operate the device. In such cases, non-sterile components may enter the sterile field and negate the sterility of the sterile field. The 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 catheters of invasive deployment systems must interface with electronic controllers that cannot be sterilized.

[0027] Examples of such in vivo deployable systems include optical coherence tomography (OCT) catheter systems, which include a catheter containing imaging optics that interfaces with a pullback system capable of catheter deployment and imaging. The pullback system interfaces with a computer system responsible for digital operation of the system.

[0028] Figure 1An exemplary medical imaging system 1100 is shown. The medical imaging system 1100 includes an imaging console 1110 and a mechanically rotating optical probe 1120 (e.g., an endoscope or a 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, etc. The optical probe 1120 may include, for example, a fiber-based catheter 1124 and a catheter handle 1122. The handle 1122 has a proximal end and a distal end extending in the z-axis direction. In an exemplary imaging procedure, the imaging system console 1100 controls the catheter 1124 via the PIU 1130 to obtain an image of a target sample (not shown), such as a cardiovascular body cavity of a patient.

[0029] PIU1130 is the main interface between the probe 1120 and the system console 1110. PIU1130 provides a means for rotating and linearly translating the imaging core of the catheter within the fixed outer sheath (not marked) of the catheter. The system console 1110 and PIU1130 are interconnected by a cable bundle 1106. The cable bundle 1106 contains cables for transmitting power and cables for communication signal transmission and optical fibers for illumination light. During the use of the imaging system console 1100, the entire PIU1130 is preferably covered by a sterile drape / bag 1200 and placed on a bed or operating table. PIU1130 can provide a user interface for operating the imaging function of the probe from the sterile field by using operable buttons 1131; these buttons 1131 can reflect other controls provided on the graphical user interface (GUI) at the imaging console 1110. The status of each button 1131 (e.g., active, inactive, warning, etc.) is communicated through indicator LEDs 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 can perform the same operations from a non-sterile area using the GUI in the display 1104 or from a sterile area using the buttons 1131 on the PIU 1130. The PIU 1130 consists of a beam combiner (not shown), a fiber optic rotary joint (FORJ), a motion mechanism including a rotary motor and a linear stage, an electronic control board, a control button and / or LED panel 1131, and a catheter receptacle 1150.

[0030] The catheter 1124 and the handle 1122 to which the catheter is attached are intended to be single-use, sterile components. However, due to the costs associated with maintaining or rendering sterility prior to use or the costs associated with implementation as a disposable component, the PIU 1130 and the pullback unit that interfaces with the catheter (included in the PIU, but not shown) must be multiple-use and non-sterile. The PIU 1130 and the pullback unit must enter the sterile field when attached to the catheter to facilitate proper catheter deployment control and repositioning. Therefore, a sterile barrier must be introduced between the PIU 1130 and its cable bundle 1106 and the sterile surfaces (e.g., an operating table) and the catheter handle with which it contacts to avoid contaminating these sterile surfaces.

[0031] To this end, the present disclosure provides a novel sterile barrier (sterile bag or sterile cover) 1200, which extends over the non-sterile components of the device (non-sterile components are required to enter the sterile field). It is worth noting that this novel sterile barrier allows the sterile components of the device to be interfaced while meeting the need to maintain sterility in the sterile field during device deployment and use.

[0032] Figure 2 An exemplary embodiment of a sterile bag 1200 is shown deployed over non-sterile components of an imaging system 1100. Figure 2 In the figure, the proximal end of the bag and the distal end of the bag are shown along the deployment direction. Figure 2 As shown, the sterile bag 1200 includes a flexible main body portion 1202, a barrier portion 1210, and an attachment portion 1220. The flexible main 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 that the flexible main body portion 1202 is any sterile covering structure having a hollow opening passing through the center, forming a tube, and can have many different sizes and shapes. For example, in some embodiments the flexible main body portion 1202 can have a long and narrow tubular shape, while in other embodiments the flexible main body portion 1202 can have a short and wide tubular shape. In addition, the term "tubular" does not necessarily limit the flexible main body portion 1202 to a tubular shape having a circular cross-section. In the present disclosure, the flexible main body portion 1202 can have a generally cylindrical tubular shape, such as Figure 2 1202. 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 other embodiments, the flexible body portion 1202 may have an irregular tubular shape; or the flexible body portion 1202 may be opened as a flat plate, rolled up at one end to form the outer edge of the barrier portion 1210, and the other end (attachment portion 1220) is attached to the surface of the computer cart 1102. Figure 2In the embodiment of the present invention, for the convenience of explanation, the flexible main body portion 1202 is shown as a tube, but it is not limited to a tube shape. In fact, in order to facilitate the manipulation and engagement / disengagement of sterile and non-sterile components, the flexible main body portion 1202 can adopt any shape to even conform to the shape of the covered medical device. In terms of materials, the flexible main body portion 1202 can be made of any suitable flexible material, including fabrics and / or plastic materials commonly used for conventional medical drapes.

[0033] The barrier portion 1210 includes an outer edge 1212 and a channel 1211 (a central opening or through hole). The attachment portion 1220 includes one or more attachment components, such as an attachment pull tab 1221 having a through hole 1222. In the unfolded state, the flexible body portion 1202 of the sterile bag (or sterile cover) 1200 has a substantially tubular shape and is configured to enclose non-sterile components therein, and in this embodiment, the non-sterile components include at least the PIU 1130 and the cable bundle 1106.

[0034] In one embodiment, in order to reduce the possibility of contact between the sterile bag 1200 and non-sterile surfaces during or after deployment, the attachment portion 1220 may include two or more pull tabs 1221, each pull tab 1221 having a small diameter through hole 1221. In addition, 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 computer cart 1102 body. The sterile bag 1200 can be held by the hook 1223 when it is deployed by a non-sterile user to avoid contact between the sterile surface of the bag and the user. When fully deployed, the pull tab 1221 can be attached to the hook 1223 on the computer cart 1102 body, thereby temporarily holding the barrier in place while repositioning non-sterile components (e.g., PIU 1130). Therefore, the possibility of contact between the outer surface of the sterile bag and the non-sterile surface outside the sterile field is reduced. Figure 2 The complete device is shown with the sterile bag 1200 deployed and attached to the hook 1223, reducing the possibility of contact between the barrier portion 1210 and the non-sterile components (PIU 1130, cable bundle 1106).

[0035] Conventionally, the process of deploying a sterile bag over non-sterile components (e.g., PIU 1130, cables, etc.) is slow because the sterile bag is provided as a separate package and must be deployed over the PIU before the catheter 1124 is engaged with the PIU. During this process, if the sterile bag comes into contact with non-sterile components, surfaces, or the user, the sterile bag may lose sterility before even entering the sterile field.

[0036] According to the present disclosure, the sterile bag is configured to be pre-installed on the disposable catheter handle 1122 in a compact (rolled or pleated) state. In this way, during the deployment process, the deployment of the sterile bag can be carried out simultaneously (in parallel) with the engagement of the catheter with the PIU. 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 before deployment and can be quickly deployed during the engagement of the catheter with the motor.

[0037] Figure 3A and Figure 3B An exemplary embodiment of the attachment portion 1220 and the barrier portion 1210 of the sterile bag 1200 is shown. Figure 2 As shown, 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 at or is attached to the barrier portion 1210. At the distal end, the flexible body portion 1202 terminates at the attachment portion 1220. Figure 3A An exemplary embodiment of the barrier portion 1210 viewed along the z-axis direction is shown. The barrier portion 1210 has or forms an opening 1211 having a diameter D1, which is sized to fit the connecting portion 1152 (engaging element) of the catheter handle 1122. The connecting portion 1152 (engaging element) of the catheter handle 1122 has a diameter "d" that is approximately the same size as the diameter D1 (d≈D1). Figure 3B An exemplary embodiment of the attachment portion 1220 is also shown as viewed along the z-axis direction. The attachment portion 1220 includes one or more (in Figure 3B In the embodiment of the present invention, there are two) attachment tabs 1221, each of which has a through hole 1222. The annular attachment portion 1220 has or forms an opening 1225 with a diameter D2 (greater than D1) and is sized to allow non-sterile components (such as PIU 1130 and cable bundle 1106) to pass through.

[0038] Here, the "loop" attachment 1220 is an optional or alternative embodiment for attaching a sterile bag or drape to the system. Figure 2 As noted and elsewhere in this disclosure, the sterile bag 1200 includes an 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. For this purpose, any other attachment structure (e.g., such as The distal end of the sterile bag 1200 is attached to a non-sterile surface (e.g., the surface of the computer cart 1102) by adhesive (e.g., adhesive such as adhesive). The attachment member may include other attachment structures that can be attached and removed in any suitable manner, such as fasteners, buckles, snaps, zippers, or any other suitable mechanism.

[0039] The annular attachment portion 1220 (attachment member) can be made of a rigid polymer, such as nylon; it can be cut from a semi-rigid polyester (Mylar) sheet, or it can even be made from sterilized cardboard, etc. Alternatively, the annular attachment portion 1220 can be just the open end of a sterile plastic bag. For example, in one embodiment, the simplest implementation of the sterile bag 1200 or sterile cover 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 implemented. In this case, the open end of the plastic bag can be reinforced with a rigid or semi-rigid material to form an annular member around the edge of the bag, and this reinforced edge can be attached to the system's computer cart. In another alternative, the open end of the plastic bag can have one or more holes punched around the edge of the bag so that the bag can be directly attached to some structure of the system's computer cart.

[0040] Figure 3C The sterile bag 1200 is shown (for ease of illustration) 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.

[0041] exist Figure 3C In the embodiment of the present invention, when the sterile bag 1200 is pre-installed on the proximal end of the catheter handle 1122, the opening 1211 of the barrier portion 1210 slides over the connecting portion 1152 of the catheter handle 1122 while the attachment portion 1220 and the flexible main body portion 1202 are pulled in the z-axis direction (toward the distal end of the catheter handle). The opening 1211 slides on the connecting portion 1152 until the barrier portion 1210 abuts against the flange 1122a of the catheter handle 1122. In order to maintain the sterility of the catheter handle 1122 and the sterile bag 1200, at least a portion of the inner surface 1202a of the flexible main body portion 1202 is exposed to the outside during the pre-installation process. Then, after the sterile bag is pre-installed on the catheter handle 1122, the flexible main body portion 1202, the barrier portion 1210 and the attachment portion 1220 are rolled or wrinkled or folded or pleated to maintain compactness before unfolding. In other embodiments, the sterile bag 1200 can be deployed onto a non-sterile device without being pre-installed onto a sterile device.

[0042] Figure 4A and Figure 4BAn exemplary process of deploying a preloaded sterile bag 1200 on a non-sterile component in parallel with the catheter being engaged to the PIU is shown. According to the present disclosure, preloading the sterile bag 1200 on the sterile component of the system provides a significant advantage in usability, such that when the mating process between the sterile component and the non-sterile component is carried out, any necessary bonding procedures between the two components, which are manifested as electrical, mechanical, optical processes, etc., can occur in parallel with the deployment of the sterile bag 1200 on the non-sterile component (e.g., PIU 1130 and cable bundle 1106). Considering that the bonding procedure can take several seconds, preloading the sterile bag on the sterile component eliminates any additional time required for the situation where a non-preloaded bag is first deployed on the non-sterile component and then takes time to mate and engage the sterile component and the non-sterile component.

[0043] Figure 4A A pre-deployment state is shown, wherein the sterile bag 1200 is pre-installed on the proximal end of the catheter handle 1122. Figure 4A The feature of the general structure before unfolding shown is that the sterile bag 1200 is composed of a rigid or semi-rigid component (barrier portion 1210) having a circular surface, which contains a through hole 1211 to allow the passage of the engaging element (connection portion 1152) of the sterile component (catheter handle 1122) responsible for cooperating with the non-sterile component (PIU 1130). The rigid or semi-rigid component (barrier portion 1210) is connected to a flexible main body portion 1202, which constitutes most of the surface area of ​​the sterile bag 1200. The sterile bag 1200 is pleated or folded so that the flexible main body surface 1202a that will contact the surface of the non-sterile component when unfolded faces outward before unfolding, and the outward sterile surface 1202b faces inward, and remains sterile before unfolding. The semi-rigidity of the barrier portion 1210 engaged with the engagement element (connection portion 1152) of the sterile component allows the barrier portion 1210 to be compressed before the sterile component and pre-filled bag are removed from the package, while maintaining the integrity of the connection between the sterile bag and the engagement element before and during deployment. The flexible body portion 1202 of the sterile bag 1200 can be rolled or pleated or wrinkled or folded before deployment so that the inner surface 1202a faces outward (see Figure 3C ) to minimize the possibility of contact between the outer surface 1202b that needs to be maintained sterile and other non-sterile surfaces.

[0044] Figure 4BThe sterile bag 1200 is shown in its unfolded state. The sterile bag 1200 before preloading and unfolding can be located on the engagement element (connection portion 1152) of the sterile component (catheter handle 1122). It is recommended to do so in order to minimize interference with the operation of the sterile component after the sterile bag 1200 is unfolded on the non-sterile component 1130. Specifically, it is advantageous to preload the sterile bag 1200 on the engagement element (connection portion 1152) of the sterile component (catheter handle 1122) in order to facilitate unfolding on the non-sterile component and fix the semi-rigid component of the sterile barrier between the non-sterile component and the sterile component after mating and engagement.

[0045] In the event that the sterility of the sterile bag 1200 is compromised, such as when the bag 1200 may lose sterility after deployment through contact with a non-sterile surface or the flexible body portion 1202 may be punctured, cut, etc., it is proposed that the sterile bag 1200 disclosed herein can be easily removed and replaced, or simply replaced. This process can be performed before or after the sterile and non-sterile components are mated. In the event that the sterile bag is removed and replaced before the components are mated and the bag is deployed, removing the folded / pleated sterile barrier from the engaging element (connecting portion 1152) simply involves disengaging the mechanism that temporarily attaches it to the element (e.g., at the end of the bag). Figure 3C ) and attach a new folded / pleated sterile barrier using the same mechanism. In the event that the sterile barrier is replaced after mating and engagement, the barrier can be removed by one of the aforementioned engagement element mechanisms before or after deployment without removing the sterile components, and a new folded / pleated sterile barrier can be put over the sterile components and attached by the same mechanism. In addition, if the integrity of the barrier to be replaced permits, the new barrier or sterile bag 1200 can simply be attached and deployed over the previous barrier or sterile bag without removing the other barrier or sterile bag. This mechanism allows the barrier or bag 1200 to be replaced without removing or replacing sterile components, thereby providing significant time and cost advantages compared to permanently attached barriers.

[0046] In the event that the sterile component is compromised, such as when the engagement mechanism may fail or the sterility of the sterile component is compromised, if the sterile barrier or bag 1200 has been deployed on the non-sterile component, the bag or barrier can 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 replacement of sterile components without having to replace the sterile barrier or bag 1200 that has been deployed on the non-sterile component, providing a significant time advantage over permanently attached barriers that need to be re-deployed when sterile components need to be replaced.

[0047] As described above, the manner of preloading the sterile bag 1200 onto the catheter handle 1122 is not limited to the use of a rigid or semi-rigid barrier portion 1210. The present disclosure also utilizes several other structures to attach the rigid or semi-rigid barrier portion 1210 to the coupling element (connecting portion 1152) of the catheter handle. The basic structure may be characterized in that the previously described semi-rigid barrier component (barrier portion 1210) has a through hole 1211, and the diameter D1 of the through hole 1211 is slightly smaller than the diameter of the coupling element (connecting portion 1152). This allows the barrier portion 1210 to be held in place using the elastic force and friction of the barrier component. However, other structures and configurations may also be used for the barrier portion 1210, such as Figure 5A-5F shown.

[0048] Figure 5A An embodiment of the barrier portion 1210 is shown 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 Figure 3A as described. Figure 5B Another embodiment of the barrier portion 1210 is shown as a barrier component made of a rigid material (such as Figure 5A The barrier components have a higher stiffness). Figure 5B The barrier member includes a plurality of perforations "p" for providing a certain flexibility or elasticity to the rigid material. Figure 5B In the embodiment, the barrier portion 1210 has an internal opening or through hole 1211, which has a diameter slightly smaller than the diameter of the engagement element (connection portion 1152), but the sides have a higher stiffness, allowing for higher resistance during pre-installation and easier translation of the flexible main body portion in the deployment direction.

[0049] Figure 5C Another embodiment of the barrier portion 1210 is shown, having a "roset" concept, relying on a ring with a diameter D1 smaller than the diameter of the engagement element (connection portion 1152), but with 3 branches 1213 having a radius larger than the engagement element radius. Figure 5D A "roset" concept is shown, relying on a ring with a diameter D1 smaller than the diameter of the engagement element (connection 1152), but with 4 branches 1213 with a radius larger than the engagement element radius. Figure 5C and Figure 5D In the embodiment, the barrier portion 1210 has a through hole with a smaller diameter than the coupling element (connection portion 1152), but the material has a higher rigidity. In this case, the multiple branches of the wreath are flexible, allowing the bag to be pre-loaded in the direction (see Figure 3C ) is easier to translate and in the direction of the bag unfolding onto the non-sterile parts (see Figure 4B ) is more difficult to translate.

[0050] Figure 5E and Fig. 5FAnother embodiment of a barrier portion 1210 is shown, shown as a rigid barrier component having a slot or central opening 1211, with circular cutouts (cut-out sectors) configured to engage with sector protrusions or keys 1153 of an engagement element (connection portion 1152) of a sterile component. These circular cutouts (or cut-out sectors) around the through hole 1211 serve as a locking mechanism 1215. Figure 5E and Fig. 5F The barrier component 1210 shown in FIG. 1 is configured to be connected to a key 1153 (such as Fig. 6A and Figure 6B In this embodiment, the rigid barrier component 1210 is first aligned with the key 1153 so that the cut-out sector 1215 matches the key 1153, and then rotated in the direction R so that the cut-out sector does not match the orientation of the key 1153 on the engagement element (connection portion 1152), thereby locking the sterile bag (attached to the barrier component) in place.

[0051] The barrier component 1210 can be made of a rigid polymer (e.g., nylon), stamped from a thin semi-rigid polyester sheet, or even made from sterilized cardboard, etc. Alternatively, it can simply be a hole punched in the closed proximal end of a tubular body that is connected to a rigid flange integral with a catheter handle by glue around it. In the latter case, the flange can be removed with the handle, but the tubular body can remain on the PIU if necessary. For example, in one embodiment, the simplest implementation of a sterile bag or cover 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 is made. As described above, the holes punched in the bag can be reinforced with a rigid or semi-rigid material to form the barrier component, and the bag can be attached to the catheter handle flange with temporary glue and removed when needed. In other embodiments, the plastic bag with holes punched in the bottom can be directly attached to the flange 1122a of the catheter handle 1122. In this case, the barrier component 1210 has no physical outer edge because it is simply glued to the bottom of the tubular bag of the flange 1122a.

[0052] According to the present disclosure, by pre-loading the sterile bag 1200 to the catheter handle 1122 (sterile component), the non-sterile surface of the flexible body of the bag is facing outward before deployment, and the drape deployment is allowed to be carried out simultaneously with the coordination of the non-sterile and sterile components of the device, so that the time required to fully prepare the device for use is reduced. In addition, in the case where the sterility of the outer surface of the sterile bag is compromised, the method of attaching the barrier component to the sterile component allows for the rapid removal and replacement of the sterile bag or the deployment of another sterile bag on the already deployed bag without removing the sterile component that has been connected to the non-sterile component. This advantageously reduces the time and cost associated with replacing a damaged sterile bag or replacing the sterile component. In addition, the sterile component of the device can be replaced without replacing the sterile barrier, and if the barrier has been deployed on the non-sterile component of the device, the barrier can remain deployed when the sterile component is replaced, which also reduces the time and burden required to remove and re-deploy the sterile bag if the sterile bag is permanently attached to the sterile component.

[0053] Another advantage is that an attachment tab is provided at the distal end of the sterile bag, thereby allowing easy deployment by a non-sterile user without compromising the sterility of the sterile bag, and also providing a method of attaching the sterile barrier to a surface so as to avoid contact between the external sterile surface and the non-sterile surface before the barrier is brought into the sterile field. In this regard, although the attachment component has been described as an attachable tab having a through hole that engages with a hook, the attachment component is not limited to a tab and a corresponding hook. Any other attachment structure (e.g., such as The distal end of the sterile bag 1200 is attached to a non-sterile surface (e.g., the surface of the computer cart 1102) by adhesive (e.g., adhesive such as adhesive). The attachment member may include other attachment structures that can be attached and removed in any suitable manner, such as fasteners, buckles, snaps, zippers, or any other suitable mechanism.

[0054] The material of sterile cover should be selected to provide enough barriers to prevent penetration contamination. Therefore, conventionally adopt nonwoven polymer film (such as polyethylene, polyvinyl chloride, polyurethane, polystyrene, polycarbonate, acrylic resin, silicone rubber, polypropylene, synthetic rubber etc.), preferably transparent so that easy to use. In addition, selected material should be able to withstand the sterilization method selected for aseptic parts. For example, for the aseptic parts comprising plastics and needing ethylene oxide (EtO) sterilization method, 2 mil thick polyethylene film and 10 mil thick polyester semi-rigid barrier parts can be used.

[0055] The embodiments of the present disclosure may be modified and / or combined with each other. In addition, it should be understood that various modifications may be made without departing from the scope of the disclosed embodiments.

[0056] In the present disclosure, pre-loading the sterile barrier onto the sterile component of the medical device system provides a significant advantage in usability, so that when the mating process between the sterile component and the non-sterile component is carried out, any necessary bonding procedures between the two components, such as electrical, mechanical or optical processes, etc., can be carried out simultaneously with the deployment of the sterile barrier onto the non-sterile component. Considering that the bonding procedure can take several seconds, pre-loading the barrier onto the sterile component eliminates any additional time required to first deploy the non-pre-loaded barrier onto the non-sterile component and then take the time to mate and bond the sterile component and the non-sterile component. Figure 4A The general configuration before deployment shown in is characterized in that the sterile barrier includes a barrier component in the shape of a semi-rigid circular surface, the circular surface containing a through hole (central opening) to allow the passage of the engaging element (connecting portion 1152) of the sterile component (catheter handle 1122) responsible for mating with the non-sterile component. The semi-rigid barrier component portion 1210 is connected to the flexible main body portion 1202 that constitutes most of the surface area of ​​the sterile barrier or bag 1200, and the sterile barrier or bag is pleated or folded so that the flexible main body surface 1202a that will contact the non-sterile component surface when deployed faces outward before deployment, while the outward sterile surface 1202b of the flexible body faces inward, thereby maintaining sterility before deployment. The semi-rigidity of the barrier component allows the interface with the engaging element (connecting portion 1152) of the sterile component and allows the flexible body to be pressed against the barrier component before the sterile component and the pre-installed barrier are removed from the package, while maintaining the integrity of the connection between the sterile barrier and the engaging element before and during deployment. The barrier can be rolled / pleated so that the inner surface faces outward before deployment to minimize the possibility of contact between the outer surface that needs to remain sterile and other non-sterile surfaces. The barrier before deployment can be located on the engaging element of the sterile component to minimize interference with the operation of the sterile component after deployment, to facilitate deployment on the non-sterile component, and to secure the semi-rigid component of the sterile barrier between the non-sterile component and the sterile component after mating and engagement.

[0057] According to another embodiment, the sterile bag 1200 is not pre-installed on the sterile component, but can be directly deployed on the non-sterile component while (or just before) the sterile component is joined with the non-sterile component that is already covered by the sterile barrier, drape or bag 1200. Fig. 7A , Figure 7B and Figure 7C Details of an exemplary sterile cover, drape or bag 1200 are shown. Fig. 7A A perspective view of a sterile cover, drape or bag 1200 is shown in a pre-assembled and pre-deployed state. The sterile bag 1200 has a tubular flexible body portion 1202, a barrier portion 1210 and an attachment portion 1220. In the pre-assembled state, at least a portion of the non-sterile inner surface 1202a of the bag 1200 is exposed to the outside. Figure 7A-7CIn the illustrated embodiment, in the pre-assembled state, the flexible main body portion 1202 is rolled or wrinkled or folded or pleated (see detail A) to maintain compactness before unfolding. Figure 7B Shows Fig. 7A Detail A is provided as an example of how the bag 1200 is folded before loading and unfolding the bag. Specifically, before unfolding, the sealed end (barrier portion side) and the open end (attachment portion side) are substantially in the same plane, and the main body 1202 is folded into multiple z-folded layers to form a compact package. Figure 7C The unfolded state of the sterile bag 1200 is shown. In order to facilitate easy unfolding by a non-sterile user, one or more pull tabs 1221 are provided around the open end of the main body 1202. The pull tabs 1221 are attached to the non-sterile inner surface 1202a by an adhesive 1227 (e.g., a medical device adhesive or a curable material).

[0058] exist Figure 7A-7C In the illustrated embodiment, the barrier portion 1210 has an opening 1211 and a semi-rigid ring (see Figure 3A ), the semi-rigid loop backing adhesive is intended to provide temporary attachment of the bag 1200 to the PIU 1130 prior to deployment (see Figure 1-Figure 2 ) edge or distal end. Of course, as described in the previous embodiments, the semi-rigid ring of the adhesive backing of the barrier portion 1210 can also provide a means for pre-loading and temporarily attaching 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 manner prior to deployment, with the inner surface 1202a of the curtain facing outward prior to deployment. Before the curtain is deployed, a pull tab 1221 with an optional hole 1222 is attached to the pleated inner surface 1202a of the curtain proximal to the semi-rigid ring. The pull tab 1221 is used to pull and deploy the bag as follows: by placing the bag on the distal-most non-sterile component (primarily the PIU 1130), adhering the interior of the ring to the edge of the catheter handle or PIU and aligning the opening 1211 around the catheter insertion point, and then pulling the pull tab 1221 in the deployment direction (see Figure 7C ) to unfold the drape toward the proximal end of the PIU. Similar to the aforementioned embodiments, the diameter D1 of the opening 1211 is approximately equal to the diameter "d" of the connection portion 1152 or the sterile component (catheter handle 1122). When fully unfolded, the drape or bag 1200 will completely contain the PIU non-sterile components entering the non-sterile area, and the position will be maintained and the catheter insertion point on the catheter handle or PIU will not be covered due to the adhesion provided by the semi-rigid ring adhesive or the lock provided by the PLU / catheter handle joint. In addition, in order to secure the unfolded sterile barrier or bag 1200 to the non-sterile component, the pull tab 1221 can be tied, adhered, attached or otherwise secured to a structure on the proximal end of the PIU or the console 1110.

[0059] exist Figure 7A-7C In the embodiment, similar to Figure 4A-4B In an embodiment, in the event that the sterility of the sterile bag 1200 is compromised, such as when the bag 1200 loses sterility after being unfolded through contact with a non-sterile surface or the flexible body portion 1202 is punctured, cut, etc., the sterile bag 1200 can be easily removed and replaced, or only replaced, before or after the sterile and non-sterile components are mated. In the event that the sterile bag 1200 is removed and replaced before the components are mated, removing the folded / pleated sterile bag 1200 from the distal end of the PIU involves removing the semi-rigid ring 1210 of the backing adhesive from the catheter handle or PIU, and attaching a new folded / pleated sterile bag 1200 using the same mechanism. In the event that the damaged sterile barrier is replaced after the sterile and non-sterile components have been mated and engaged, the damaged sterile bag 1200 can be left in place and a new folded / pleated sterile barrier can be put on and attached by the same procedure. That is, if the integrity of a new sterile barrier or bag 1200 can be maintained, the new barrier or bag 1200 can simply be attached and deployed over the previous barrier or bag without removing the other damaged barrier. This mechanism allows the barrier or bag 1200 to be replaced without removing or replacing sterile components, thereby providing a significant time saving advantage over permanently attached barriers.

[0060] The advantage of the sterile barrier disclosed herein is that the sterile barrier is preloaded to the sterile part by using a rigid or semi-rigid barrier component. In this way, the non-sterile surface of the barrier can be preloaded in an outward manner before the barrier is unfolded, and the barrier is allowed to unfold and the non-sterile and sterile parts of the device are coordinated at the same time during the barrier unfolding, reducing the time required for the device to be fully prepared for use. In addition, the method for attaching the barrier to the sterile part allows the sterile barrier to be removed and replaced or another barrier to be unfolded on the barrier already in place, thereby eliminating the need to remove the sterile part of the device when the sterility of the outer surface of the barrier is impaired, reducing the time and cost associated with the requirement to replace the sterile part to replace the barrier. In addition, the sterile part of the device can be replaced without the need to replace the sterile barrier, and the barrier, if already unfolded on the non-sterile part of the device, can keep the barrier unfolded when the sterile part is replaced, which also reduces the time burden required to remove and re-expand the sterile barrier if the sterile barrier is permanently attached to the sterile part.

[0061] Another advantage of providing a pull tab 1221 at the distal end of the sterile barrier or bag 1200 is that it allows the sterile barrier to be easily unfolded by a non-sterile user without compromising the sterility of the barrier, and also provides a method for attaching the barrier to a surface to avoid contact between the exterior sterile surface 1202b and non-sterile components before the barrier or bag 1200 is brought into the sterile field.

[0062] When describing, specific details are set forth to provide a thorough understanding of the disclosed examples. In other cases, well-known methods, procedures, components and circuits are not described in detail to avoid unnecessarily lengthening the present disclosure. Unless otherwise defined herein, all scientific and technological terms used herein are the same as the meanings commonly understood by those of ordinary skill in the art to which the present invention belongs. The scope of the present invention is not limited by the subject specification, but only by the simple meaning of the claimed terms adopted. 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 "unsterilized" are used interchangeably to indicate that it is not free of living organisms and microorganisms, such as in non-sterile medical devices or in medical operations performed in non-sterile environments.

[0063] It should be understood that if an element or portion is referred to herein as "on," "against," "connected to," or "coupled to" another element or portion, it may be directly on, against, connected to, or coupled to the other element or portion, or there may be intervening elements or portions. Conversely, if an element is referred to as "directly on," "directly connected to," or "directly coupled to" another element or portion, there may be no intervening elements or portions. When used, the term "and / or" may be abbreviated as " / ," which includes any and all combinations of one or more of the associated listed items (if provided).

[0064] Spatially related terms, such as "below," "beneath," "under," "lower," "above," "upper," "near," "far," and the like, may be used herein for ease of description to describe the relationship of one element or feature relative to another element or feature, as shown in the various figures. It should be understood, however, that the spatially related terms are intended to encompass different orientations of the device in use or operation, in addition to the orientations depicted in the figures. For example, if the device in the figures is flipped, an element described as "below other elements or features" or "below other elements or features" would be oriented as "above the other elements or features." Thus, spatially related terms such as "below" may include both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein will be interpreted accordingly. Similarly, the spatially related terms "near" and "far" may also be interchangeable, where applicable.

[0065] As used herein, the term "about" or "roughly" refers to, for example, within 10%, within 5% or less. In some embodiments, the term "about" may be expressed as being within the range of measurement error. In this regard, in the description or claim, all numbers may be understood to begin with the term "about" or "roughly", even if the term does not appear explicitly. When describing size and / or position, the phrase "about" or "roughly" may be used to indicate that the value and / or position described is within the reasonable expected range of value and / or position. For example, a numerical value may have a value within the range of + / -0.1% of the listed value (or value range), + / -1% of the listed value (or value range), + / -2% of the listed value (or value range), + / -5% of the listed value (or value range), + / -10% of the listed value (or value range), etc. Any numerical range (if mentioned in this article) is intended to include all subranges contained therein.

[0066] The terms first, second, third, etc. may be used in this article to describe various elements, components, regions, parts and / or sections. It should be understood that these elements, components, regions, parts and / or sections should not be limited by these terms. These terms are only used to distinguish an element, component, region, part or section from another region, part or section. Therefore, without departing from the teachings of this article, the first element, component, region, part or section discussed below may be referred to as the second element, component, region, part or section.

[0067] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to be limiting. The singular forms "one", "an", "said", "the" used herein are also intended to include plural forms unless the context clearly indicates otherwise. It should also be understood that the terms "include" and / or "comprise" when used in this specification indicate the presence of listed features, components, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, components, steps, operations, elements, parts and / or their groups that are not explicitly listed. It should also be noted that some claims may be written to exclude any optional elements; such claims may use exclusive terms such as "only", "only" and the like related to the description of claim elements, or may use "negative" limitations.

[0068] In describing the example embodiments shown 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.

[0069] Although the present disclosure has been described with reference to exemplary embodiments, it should be understood that the present 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 modifications and equivalent structures and functions.

Claims

1. A sterile cover for covering a medical device, comprising: a barrier portion made of a rigid or semi-rigid material and having a central opening; and a flexible main body portion extending from the proximal end to the distal end and having an outer surface, an inner surface and an open end, wherein the barrier portion is coupled to the proximal end of the flexible main body portion, Among them, when the barrier part is installed on the sterile part of the medical device, the sterile cover is in a pre-installed state. The sterile cover is in an unfolded state when the flexible main body is unfolded on the non-sterile component to enclose the non-sterile component in the flexible main body. Wherein, the sterile component comprises a connecting portion, which is configured to pass through the central opening of the barrier portion and connect to the non-sterile component; wherein the central opening includes a plurality of flexible branches arranged in a circular arrangement and configured to fit tightly over and slide over the connection portion of the sterile component; The diameter of the circular arrangement of the plurality of flexible branches is smaller than the diameter of the connecting portion, so that the resistance to translation of the barrier portion on the connecting portion is smaller in the pre-installed state than in the deployed state.

2. The sterile cover according to claim 1, in, The flexible main body portion is placed on the sterile component before deployment by sliding the central opening of the barrier portion onto the sterile component connecting portion that mates with the non-sterile component.

3. The sterile cover according to claim 1, wherein: The sterile drape is pre-installed on the sterile component in a pleated or folded state.

4. The sterile cover according to claim 1, further comprising: An attachment portion is disposed at the distal end of the flexible body portion, the attachment portion being configured to provide an interface for a non-sterile user to unfold the sterile cover over a non-sterile component without contacting a sterile surface and to secure the distal end of the flexible body portion after unfolding to prevent contact with the non-sterile surface.

5. The sterile cover according to claim 4, in, The attachment portion includes one or more pull tabs arranged at the distal end of the flexible body portion around the open end of the flexible body portion, Wherein, the one or more pull tabs are configured to be attached to a non-sterile surface of a medical device.

6. 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 onto the connecting portion of the sterile component.

7. The sterile cover according to claim 1, in, The barrier is an adhesive-backed rigid or semi-rigid component having through holes. wherein the adhesive-backed rigid or semi-rigid component is configured to be temporarily attached to the distal end of the non-sterile component, Therein, the through hole is aligned with the connecting portion of the sterile component.

8. The sterile cover according to claim 1, in, The flexible main body is a long tubular plastic bag with a hole at the bottom. The hole at the bottom of the plastic bag is the central opening of the barrier part. The sterile part is connected to the non-sterile part via a hole in the bottom of the plastic bag.

9. The sterile cover according to claim 1, wherein: The flexible body portion has a tubular shape configured to fit over a non-sterile component.

10. The sterile cover according to claim 4, in, The attachment portion includes an annular structure disposed at a distal end of the flexible main body portion around an open end of the flexible main body portion, Therein, the annular structure has one or more holes configured to engage with a non-sterile surface of a medical device.

11. A sterile barrier or drape configured to be pre-installed on a sterile component to be mated or engaged with a non-sterile component, the sterile barrier or drape comprising: a barrier member made of a rigid or semi-rigid material and having a central opening; and a flexible body having a hollow passage extending from a proximal end to a distal end and having an outer surface, an inner surface and an open end, wherein the barrier component is coupled to the proximal end of the flexible body; Among them, when the barrier component is installed on the sterile component, the sterile barrier or curtain is in a pre-installed state. wherein the sterile barrier or drape is in an unfolded state when the flexible body is configured to unfold over the non-sterile component to enclose the non-sterile component within the inner surface of the flexible body, and the non-sterile component is removably connected to the sterile component by passing the connecting portion of the sterile component through the central opening of the barrier component; wherein the central opening of the barrier member includes one or more cutouts extending from the central opening; Wherein, the one or more cutouts are configured to rotatably engage with one or more keys formed in the connecting portion of the sterile component so that the one or more cutouts serve as a locking mechanism to removably secure the sterile barrier or drape to the sterile component.

12. The sterile barrier or drape of claim 11, wherein: The sterile barrier or drape is a first sterile barrier or drape configured to be temporarily attached to the sterile component and configured to be removed from the sterile component and replaced with, or only replaced with, a second sterile barrier or drape at any point before or after the barrier is deployed and the sterile and non-sterile components are mated.

13. The sterile barrier or drape of claim 11, wherein: The sterile barrier or drape is configured such that sterile components can be removed and replaced without removing the sterile barrier or drape after the barrier or drape is deployed.

14. The sterile barrier or drape of claim 11, wherein: The sterile barrier or drape has a tubular opening with a proximal end and a distal end. Also included is a fixing device on the distal end of the sterile barrier or drape for providing an interface for a non-sterile user to unfold the sterile barrier or drape without contacting a sterile surface and to fix the distal end of the sterile barrier or drape after unfolding, thereby preventing contact with a non-sterile surface.

15. A method of providing a sterile barrier or drape pre-installed on a sterile component of a medical device, the sterile component being attachable to a non-sterile component of the medical device, the method comprising: providing a sterile barrier or drape having a barrier portion and a flexible body portion coupled to the barrier portion; The barrier portion has a central opening, and 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; pre-installing the barrier portion onto the sterile component by sliding the central opening of the barrier portion onto the connecting portion of the sterile component; and while passing the connecting portion of the sterile component through the central opening of the barrier portion and connecting the sterile component to the non-sterile component via the central opening of the barrier portion, unfolding the flexible main body portion over the non-sterile component to enclose the non-sterile component within the inner surface of the flexible main body portion; Wherein, the barrier part is made of a rigid or semi-rigid material; wherein the central opening of the barrier portion includes one or more cutouts extending from the central opening; Wherein, the one or more cutouts are configured to rotatably engage with one or more keys formed in the connecting portion of the sterile component so that the one or more cutouts serve as a locking mechanism to removably secure the sterile barrier or drape to the sterile component.

16. The method according to claim 15, further comprising: After the flexible body portion is deployed on the non-sterile component, the barrier portion is removed and replaced without removing the flexible body portion or only replaced.

17. The method according to claim 15, further comprising: After the flexible body portion is deployed over the non-sterile component, the barrier portion and / or the flexible body portion are removed and replaced or only replaced without disconnecting the sterile component from the non-sterile component.

18. A method of providing a sterile cover for covering a medical device, the method comprising: providing a sterile cover having a barrier portion and a flexible body portion, the flexible body portion coupled to the barrier portion; The barrier portion has a central opening, and 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; Pre-installing the sterile cover onto the sterile component by sliding the central opening of the barrier portion onto the connecting portion of the sterile component, thereby placing the sterile cover in a pre-installed state; and While passing the connecting portion of the sterile component through the central opening of the barrier portion and connecting the sterile component to the non-sterile component via the central opening of the barrier portion, unfolding the flexible main body portion on the non-sterile component to enclose the non-sterile component within the inner surface of the flexible main body portion, thereby placing the sterile cover in an unfolded state; Wherein, the barrier part is made of a rigid or semi-rigid material; wherein the central opening includes a plurality of flexible branches arranged in a circular arrangement and configured to fit tightly over and slide over the connection portion of the sterile component; The diameter of the circular arrangement of the plurality of flexible branches is smaller than the diameter of the connecting portion, so that the resistance to translation of the barrier portion on the connecting portion is smaller in the pre-installed state than in the deployed state.

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