Sterile sheath with access port

Abstract

A sterile sheath is configured to encase a non-sterile medical instrument. Certain non-sterile medical instruments, such as consoles and computing devices, are not easily sterilized without damaging the instrument itself. Therefore, such non-sterile medical instruments are left outside the sterile field. Engaging these non-sterile medical instruments with sterile medical instruments within the sterile field can compromise the sterility of the sterile field. Disclosed herein is a sheath configured to encase a portion of a non-sterile medical instrument. Additionally, the sheath may include an access port that allows one or more sterile medical instruments to engage the non-sterile medical instruments disposed within the sheath.

Description

[Technical Field]

[0001] The present invention relates to a sterile sheath having an access port. Summary of the Invention

[0002] Briefly summarized, embodiments disclosed herein relate to an apparatus and method for a sterile sheath configured to enshroud a non-sterile medical instrument. Within a sterile environment, a variety of sterile medical instruments may be brought into the sterile field. These sterile medical instruments tend to be disposable and / or cleanable for re-sterilization and reuse. However, certain non-sterile medical instruments, such as consoles, computing devices, etc., are not easily sterilized without damaging the device itself and / or are too expensive for single-use. Therefore, such non-sterile medical instruments remain outside the sterile field.

[0003] Situations may arise where a non-sterile medical instrument needs to engage or communicate with a sterile medical instrument within a sterile field without compromising the sterile field. For example, to communicate wirelessly, the non-sterile medical instrument needs to be in close proximity to the patient or in close proximity to the sterile medical instrument. Alternatively, for wired communication, the non-sterile medical instrument needs to be directly engaged (e.g., connected) to the sterile medical instrument.

[0004] Disclosed herein is a sheath for encasing a non-sterile medical instrument, the sheath including: a body defining an elongated cavity and communicating with an opening at a first end; and a port disposed at a second end of the body opposite the first end, the port defining an aperture and including a cap selectively removable from the aperture to allow a portion of the sterile medical instrument to pass through the opening.

[0005] In some embodiments, the body is formed from a first material that is a flexible, gas impermeable material. In some embodiments, the body includes a sterile surface on a first side and a non-sterile surface on a second side opposite the first side.

[0006] In some embodiments, the body is configured to pass through an opening at the first end to transition the body between a first configuration in which the non-sterile surface is disposed on the outside and a second configuration in which the sterile surface is disposed on the outside.

[0007] In some embodiments, the sheath further includes a first adhesive layer disposed on at least a portion of the first side and configured to secure the sheath to a portion of the sterile field. In some embodiments, the first adhesive layer extends from the port to the opening in the first end.

[0008] In some embodiments, the sheath further comprises a release layer disposed on the first adhesive layer. In some embodiments, the sheath further includes a second adhesive layer disposed on at least a portion of the second side and configured to releasably secure a portion of the sheath to a non-sterile medical instrument.

[0009] In some embodiments, the port is formed from a second material that is stiffer than the first material. In some embodiments, the second material comprises a plastic, a polymer, a rubber, or a silicone rubber.

[0010] In some embodiments, one or both of the cap and the port opening include an adhesive layer configured to releasably secure the cap over the opening and provide a seal therebetween.

[0011] In some embodiments, the cap engages the opening with a threaded, press-fit, interference, or snap-fit ​​engagement to releasably secure the cap over the opening and form a seal therebetween.

[0012] Also disclosed herein is a method of securing a non-sterile medical instrument within a sterile field, the method including: providing a sheath having an elongate body defining a cavity and extending to an opening disposed at a first end, the sheath including a non-sterile surface disposed on a first side of the body and a sterile surface disposed on a second side of the body; inverting the elongate body to a first configuration by urging the body through the opening so that the non-sterile surface is disposed outward, engaging a portion of the non-sterile surface with the non-sterile medical instrument; inverting the elongate body from the first configuration to a second configuration in which the sterile surface is disposed outward; and adhering a portion of the second side of the elongate body to the sterile field.

[0013] In some embodiments, the method further includes removing a cap from a port aperture located at a second end of the sheath opposite the opening at the first end to provide access to a non-sterile medical instrument placed within the cavity.

[0014] In some embodiments, the method further includes extending a portion of the sterile medical instrument through the port opening and securing a cap to the port opening, wherein the portion of the sterile medical instrument passes between the cap and a wall of the opening and is sealed therein to maintain a barrier between the non-sterile medical instrument and the sterile field.

[0015] A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1] 1 illustrates a sheath in an exemplary environment of use, according to embodiments disclosed herein. [Figure 2A] 1 illustrates a sheath in a first configuration according to an embodiment disclosed herein. [Figure 2B] 1 illustrates a sheath in a second configuration according to an embodiment disclosed herein. [Figure 3A] 1 illustrates an exemplary method of use of a sheath according to embodiments disclosed herein. [Figure 3B] 1 illustrates an exemplary method of use of a sheath according to embodiments disclosed herein. [Figure 3C] 1 illustrates an exemplary method of use of a sheath according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0017] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0018] term With regard to the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Designations such as "left," "right," "up," "down," "top," "bottom," "front," and "rear" are used for convenience and do not, for example, imply a specific, fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction.

[0019] In the following description, the terms "or" and "and / or" as used herein should be interpreted as being inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A, B, C, A and B, A and C, B and C, A, B and C." "any of the following: A, B, C, A and B, A and C, B and C, A, B and C." ← Deleted later. Exceptions to this definition occur only where combinations of elements, components, features, steps or actions are in some way inherently mutually exclusive.

[0020] To aid in illustrating the embodiments described herein, a coordinate axis representation is shown in FIG. 2B, where the longitudinal axis of the sheath extends parallel to the axial length of the sheath's cavity, the transverse axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and transverse axes.

[0021] For example, references to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0022] For example, references to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is in use with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. FIG. 1 illustrates an exemplary use environment 10 for a sterile sheath ("sheath") 100 as disclosed herein. The exemplary use environment 10 may include an operating table, an operating room, a sterile drape, or any area where a sterile field is established. As shown, the exemplary use environment 10 may include, but is not limited to, a sterile field 18 with an operating table 12 on which a patient 14 is positioned. The exemplary use environment 10 may include one or more sterile medical instruments 28 that may enter (i.e., be disposed within) the sterile field 18. Exemplary sterile medical instruments 28 include, but are not limited to, catheters, needles, stylets, scalpels, gauze, drapes, etc. The exemplary use environment 10 may further include one or more non-sterile medical instruments, e.g., a console 22, disposed outside the sterile field 18, i.e., within a non-sterile field 20.

[0024] In one embodiment, one or more non-sterile medical devices, e.g., connector 24 and / or wire harness 26, must extend into the sterile field 18 to be positioned near the patient 14 in order to function properly. For example, connector 24 may include a wireless antenna that must be within range of a sterile wireless medical device 28 within the sterile field 18. Alternatively, the sterile medical device 28 must engage with the non-sterile connector 24 to establish wired communication therebetween. Advantageously, sheath 100 can encase a portion of the non-sterile medical device, e.g., connector 24, to maintain a boundary between the non-sterile connector 24 and the sterile field 18. This allows the non-sterile connector 24 to be positioned in proximity to the patient 14 without compromising the sterile field 18. The non-sterile connector 24 and / or wire harness 26 are exemplary and not intended to be limiting. Accordingly, sheath 100 can be configured to encase a variety of non-sterile probes, ultrasound probes, sensors, connectivity modules, communication modules, etc., allowing these devices to enter the sterile field 18 without compromising the sterility of the sterile field 18.

[0025] 2A and 2B show further details of the sheath 100. In one embodiment, the sheath 100 can include an elongate body (or wall) 106 defining a cavity 102 extending axially along a longitudinal axis. The body 106 can be formed of a first material, e.g., a thin, flexible, gas-impermeable material such as a woven or nonwoven fabric, transparent, translucent, or opaque, plastic, polymer, polyurethane, or combinations thereof. The cavity 102 can communicate with an opening 104 disposed at a first end. The opening 104 can be disposed outside the sterile field 18. The body 106 of the sheath 100 can extend from the opening 104 at the first end to a base 108 disposed at a second end opposite the first end. Additionally, the body 106 of the sheath 100 may include a sterile surface 110 disposed on a first side of the body 106 and a non-sterile surface 112 disposed on a second side of the body 106 opposite the first side.

[0026] As shown in Figures 2A and 2B, the sheath 100 is reversible between a first configuration (Figure 2A) and a second configuration (Figure 2B). As shown in Figure 2A, the body 106 can be urged from the opening 104 toward the cavity 102 so that the non-sterile surface 112 faces outward and the sterile surface 110 faces inward, thereby forming the sterile cavity 102. As shown in Figure 2B, the sheath 100 can be transitioned from the first configuration to the second configuration by urging the body 106 from the opening 104 so that the sterile surface 110 faces outward and the non-sterile surface 112 faces inward, thereby forming the non-sterile cavity 102.

[0027] In an exemplary method of use, the sheath 100 can be provided in a first configuration (FIG. 2A) as described herein. A clinician can place a sterile hand through the opening 104 into the sterile cavity 102, with the sterile surface 110 of the body 106 facing the interior of the cavity 102. The clinician can then grasp the non-sterile connector 24 by bringing the non-sterile surface 112 of the exteriorly disposed body 106 into contact with the non-sterile connector 24.

[0028] The clinician can then invert the sheath 100 from the first configuration to the second configuration to encase the non-sterile connector 24 within the sheath 100. In the second configuration, the sheath 100 defines a non-sterile cavity 102 having an inwardly facing non-sterile surface 112. The opening 104 can then be positioned outside the sterile field 18, while the non-sterile connector 24 housed within the cavity 102 can be positioned within the sterile field 18 (FIG. 1) without compromising the sterile field 18.

[0029] In one embodiment, the sheath 100 can include a first adhesive layer 114 disposed on a portion of the sterile surface 110, for example, adjacent the connector 24. In one embodiment, the adhesive layer 114 can extend along the entire length of the sheath 100 from the base end 108 to the opening 104. In one embodiment, the adhesive layer 114 can include a release layer 116 disposed thereon. A portion of the release layer 116 can be peeled away to expose a portion of the adhesive layer 114 disposed thereunder, allowing a user to adhere the sheath 110, including the connector 24 disposed therein, to the sterile field 18, for example, to a portion of the sterile field 18 or to a sterile object within the sterile field 18. Advantageously, the first adhesive layer 114 can mitigate slippage of the sheath 100 and connector 24 assembly from the sterile field 18. In one embodiment, the first adhesive layer 114 may be a relatively low-tac adhesive configured to allow a clinician to attach and detach the sheath 100 from the sterile field 18 as needed. In one embodiment, the release layer 116 may include one or more tear lines 116A, such as perforations, laser cut lines, score lines, etc., configured to allow a first portion of the release layer 116 to be removed while allowing a second portion of the release layer 116 to remain in place. Thus, a user can selectively expose different portions of the first adhesive layer 114 and adhere those portions to the sterile field 18 as needed, while the remainder of the first adhesive layer 114 remains covered.

[0030] In one embodiment, sheath 100 may include a second adhesive layer 118 disposed on a portion of non-sterile surface 112 and configured to releasably engage a non-sterile medical implement, such as a portion of one or both of connector 24 and wire harness 26, to, for example, secure sheath 100 thereto. Second adhesive layer 118 may also optionally include a release layer 119, similar to release layer 116, disposed thereon. Advantageously, release layer 119 disposed thereon may be selectively removable from second adhesive layer 118 depending on whether a clinician desires to further secure connector 24 within cavity 102 or whether the clinician prefers connector 24 to move freely within cavity 102. Similar to release layer 116, release layer 119 may include one or more tear lines 119A.

[0031] As shown in FIGS. 3A-3C , in one embodiment, the sheath 100 can further include a port 120 disposed at the proximal end 108 of the sheath 100 opposite the opening 104. The port 120 can generally include a port opening 122 (see FIG. 3B ) and a cap 124. In one embodiment, one or both of the wall defining the port opening 122 and the cap 124 can be formed of the same material as the body 106, i.e., the first material. The cap 124 can cover the port opening 122 (as shown in FIG. 3A ) to maintain the integrity of the sterile barrier formed by the sheath 100. The cap 124 can transition between an open configuration and a closed configuration to allow a clinician to selectively access the connector 24 through the port opening 122 of the port 120.

[0032] In one embodiment, one or both of the cap 124 and the wall defining the port opening 122 may include an adhesive layer 125 for releasably securing the cap 124 over the port opening 122. The adhesive of the adhesive layer 125 may be a relatively low tack adhesive configured to allow the cap 124 to be attached and detached from the port opening 122.

[0033] In one embodiment, a portion of the sterile medical instrument 28 can extend through the port opening 122 to engage the non-sterile connector 24 disposed within the non-sterile cavity 102. In one embodiment, a portion of the cap 124 can engage the port opening 122 and flexibly deform to form a seal around the portion of the sterile medical instrument 28 extending through the port opening 122.

[0034] In one embodiment, the port 120 can be formed of a second material that is different from the first material of the sheath body 106. In one embodiment, the port 120 can be formed of a flexible silicone rubber material. Additionally, the cap 124 can be molded into a bistable shape such that the cap 124 can remain in either an open or a closed configuration and can transition between the open and closed configurations. Additionally, the cap 124 can flexibly deform to form a seal around a portion of the sterile medical instrument 28 extending through the port opening 122, as described herein.

[0035] In one embodiment, the port 120 may be formed from a relatively rigid material and may define a port opening 122 and a cap 124. The cap 124 may be selectively attached over the port opening 122 using a threaded engagement, a press fit, an interference fit, a snap fit engagement, combinations thereof, or the like. In one embodiment, the cap 124 may be hinged to the port opening 122 using either a living hinge or a mechanical hinge. In one embodiment, the cap 124 may further include a tab, handle, finger loop, or similar gripping feature extending therefrom and configured to facilitate grasping the cap 124.

[0036] In an exemplary method of use, as shown in Figures 3A-3C, a connector 24 or similar non-sterile medical device can be placed within the sheath 100 as described herein (Figures 2A and 2B). Exemplary non-sterile medical devices include, but are not limited to, connectors 24 and wire harnesses 26 for ultrasound imaging devices, tracking devices for intracorporeal or intravascular medical devices, patient attribute recording devices configured to record pulse rate, respiratory rate, blood pressure, electrocardiogram (ECG), temperature, etc., or similar consoles 20 positioned outside the sterile field 18. Once placed within the sheath 100, the connector 24 can be placed in close proximity to the patient 14 without compromising the sterile field 18.

[0037] In one embodiment, a clinician may desire to selectively couple a sterile medical instrument 28 to the connector 24. Exemplary sterile medical instruments 28 may include, but are not limited to, an ultrasound probe, a sensor-enabled intravascular medical instrument (such as a catheter, guidewire, or stylet), an electrode, combinations thereof, or the like. Thus, as shown in FIG. 3A, a clinician can selectively remove the cap 124 to expose the port opening 122 therebelow. As shown in FIG. 3B, the clinician can then advance the sterile contacts 30 of the sterile medical instrument 28 through the port opening 122 to engage the connector 24 disposed within the sheath 100.

[0038] As shown in FIG. 3C , with a portion of the sterile medical instrument 28 extending through the port opening 122, the clinician can close the cap 124 over the port opening 122 to seal around the portion of the sterile medical instrument 28 extending through the port opening 122. For example, if the cap 124 is formed of a relatively flexible material, the cap 124 can flexibly deform around the portion of the sterile medical instrument 28. Optionally, an adhesive layer can secure the cap 124 around the portion of the sterile medical instrument 28. In one embodiment, if the cap 124 is formed of a more rigid material, the cap 124 can include a notch, gasket, bearing, valve, or similar structure configured to allow a portion of the sterile medical instrument 28 to extend therethrough while maintaining the boundary between the sterile field 18 and the non-sterile connector 24. The sheath 100 can then optionally be adhered in place using a first adhesive layer 114 disposed on the sterile surface 112. Advantageously, the sheath 100 allows the clinician to access non-sterile medical instruments within the sterile field 18 without compromising the sterility of the sterile field 18 .

[0039] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A sheath for enclosing non-sterile medical instruments, A body that defines an elongated cavity and communicates with the opening at the first end, A sheath comprising a port located at a second end of the main body opposite to the first end, the port comprising an opening and a cap selectively removable from the opening through which a portion of a sterile medical instrument can pass.

2. The sheath according to claim 1, wherein the main body is formed of a first material which is a flexible, gas-impermeable material.

3. The sheath according to claim 1 or 2, wherein the main body includes a sterile surface on a first side and a non-sterile surface on a second side opposite to the first side.

4. The sheath according to claim 3, wherein the main body is configured to pass through the opening at the first end in order to move the main body between a first configuration in which the non-sterile surface is positioned on the outside and a second configuration in which the sterile surface is positioned on the outside.

5. The sheath according to claim 3, further comprising a first adhesive layer disposed on at least a portion of the first side and configured to fix the sheath to a portion of the sterile field.

6. The sheath according to claim 5, wherein the first adhesive layer extends from the port to the opening of the first end.

7. The sheath according to claim 5, further comprising a release layer disposed on the first adhesive layer.

8. The sheath according to claim 3, further comprising a second adhesive layer disposed on at least a portion of the second side and configured to releasably secure a portion of the sheath to the non-sterile medical instrument.

9. The sheath according to claim 2, wherein the port is formed of a second material which has higher rigidity than the first material.

10. The sheath according to claim 9, wherein the second material comprises plastic, polymer, rubber, or silicone rubber.

11. The sheath according to claim 1 or 2, wherein one or both of the cap and the port opening include an adhesive layer configured to releasably secure the cap over the opening and seal the space between them.

12. The sheath according to claim 1 or 2, wherein the cap engages with the opening by screw engagement, press-fit engagement, crimp-fit ​​engagement, or snap-fit ​​engagement, thereby releasably fixing the cap over the opening and sealing the space between them.

13. A method for fixing non-sterile medical instruments within a sterile field, To provide a sheath having a long body that defines a cavity and extends to an opening located at a first end, wherein the sheath includes a non-sterile surface located on the first side of the body and a sterile surface located on the second side of the body. The main body is inverted to the first configuration by biasing it from the opening so that the non-sterile surface is positioned on the outside, A portion of the non-sterile surface is engaged with the non-sterile medical instrument, The main body is inverted from the first configuration to a second configuration in which the sterilized surface is positioned on the outside, A method comprising adhering a portion of the second side of the main body to the sterilization field.

14. The method according to claim 13, further comprising removing the cap from a port opening located at the second end of the sheath, opposite the opening at the first end, in order to access the non-sterile medical instrument placed in the cavity.

15. The method according to claim 14, further comprising extending a portion of a sterile medical instrument through the port opening and fixing the cap to the port opening, wherein the portion of the sterile medical instrument passes between the cap and the wall of the port opening and is sealed to the wall of the port opening to maintain a boundary between the non-sterile medical instrument and the sterile field.

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