Connection system and method thereof

Abstract

For example, the connection system may include a male connector associated with the SPU medical device and a female connector associated with the MPU medical device. The male connector may include a flexible member around the male connector and proximal to the plug of the male connector. The female connector may include a rigid member around the opening of the receptacle of the female connector. The flexible member may be configured to conform to the rigid member when the plug of the male connector is inserted into the receptacle of the female connector, with a procedure barrier between the flexible member and the rigid member. Insertion of the plug of the male connector into the receptacle of the female connector can establish one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device.

Description

[Background technology]

[0001] A procedural field is typically established around a patient using one or more procedural barriers before any medical procedure. For example, a sterile field can be established above or around the patient by draping the patient with a sterile drape. Often, medical procedures require multiple patient-use ("MPU") medical devices that cannot be sterilized, and such medical devices are required to be placed under a sterile drape. However, sterile single patient-use ("SPU") medical devices often need to be functionally connected to an MPU medical device. Some existing solutions rely on intentionally tearing the sterile drape to functionally connect the sterile SPU and MPU medical devices. However, this intentional tearing of the sterile drape risks contaminating the carefully established sterile field around the patient. Therefore, establishing some functional connections between the sterile SPU and MPU medical devices can be difficult, especially due to the inherent danger of tearing the sterile drape. What is needed is a connection system for establishing a safe, routine, and functional connection between a sterile SPU medical device and an MPU medical device.

[0002] Disclosed herein are connection systems and methods that address the above. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is a connection system including a male connector associated with an SPU medical device and a female connector associated with an MPU medical device. The male connector includes a flexible member around the male connector, the flexible member being proximal to a plug of the male connector. The female connector includes a rigid member around an opening of a receptacle of the female connector. The flexible member of the male connector is configured to conform to the rigid member with a procedure barrier between the SPU medical device and the MPU medical device when the plug of the male connector is inserted into the receptacle of the female connector. Insertion of the plug of the male connector into the receptacle of the female connector establishes one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device.

[0004] In some embodiments, the flexible member is fixedly coupled to the male connector. In some embodiments, the flexible member is removably coupled to the male connector.

[0005] In some embodiments, the flexible member is a flexible disc. In some embodiments, the rigid member is fixedly coupled to the female connector. In some embodiments, the rigid member is removably coupled to the female connector.

[0006] In some embodiments, the rigid member is a rigid bowl that opens away from the receptacle of the female connector. In some embodiments, when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is magnetically secured to the female connector via one or more magnets in each of the flexible and rigid members.

[0007] In some embodiments, when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is mechanically secured to the female connector via one or more retractable protrusions extending from the plug of the male connector and one or more corresponding recesses on the interior wall of the receptacle.

[0008] In some embodiments, when the plug of the male connector is inserted into the receptacle of the female connector, the one or more retractable protrusions and one or more corresponding recesses produce an audible click that indicates that the male connector is mechanically locked to the female connector.

[0009] In some embodiments, when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is adhesively secured to the female connector via adhesive on the mating surfaces of the flexible and rigid members.

[0010] In some embodiments, the flexible member conforms to the rigid member to form a fluid-tight seal. In some embodiments, the one or more functional connections are selected from an electrical connection, an optical connection, and a fluid connection.

[0011] In some embodiments, the treatment barrier is a sterile drape such that one or more functional connections across the treatment barrier between the SPU medical device and the MPU medical device extend from a sterile field containing the SPU medical device and a non-sterile field containing the MPU medical device.

[0012] Also disclosed herein, in some embodiments, is a method of connection system, including an inserting step. The inserting step includes inserting a male connector associated with the SPU medical device across a procedure barrier into a female connector associated with the multi-patient use MPU medical device. The male connector includes a flexible member around the male connector, the flexible member being proximal to a plug of the male connector. The female connector includes a rigid member around an opening of a receptacle of the female connector. The flexible member is configured to fit along the rigid member with the procedure barrier between the flexible member and the rigid member. Inserting the plug of the male connector into the receptacle of the female connector during the inserting step establishes one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device. In some embodiments, the flexible member is a flexible disk that is fixedly or removably coupled to the male connector.

[0013] In some embodiments, the rigid member is a rigid bowl fixedly or removably coupled to the female connector, the rigid bowl opening away from the receptacle of the female connector.

[0014] In some embodiments, the male connector is magnetically, mechanically, or adhesively secured to the female connector upon insertion of the plug of the male connector into the receptacle of the female connector in the inserting step, with the flexible member conforming to the rigid member to form a fluid-tight seal.

[0015] In some embodiments, the one or more functional connections are selected from an electrical connection, an optical connection, and a fluid connection. In some embodiments, the treatment barrier is a sterile drape such that one or more functional connections across the treatment barrier between the SPU medical device and the MPU medical device extend from a sterile field containing the SPU medical device and a non-sterile field containing the MPU medical device.

[0016] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0017] [Figure 1] 1 illustrates a connection system for establishing one or more functional connections across a treatment barrier between an SPU medical device and an MPU medical device, according to some embodiments. [Figure 2] 1 illustrates a detailed view of a connection system, according to some embodiments. [Figure 3] 1A-1C show longitudinal cross sections of a connection system before and after a plug of a male connector is inserted into a receptacle of a female connector, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0018] 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 a specific embodiment disclosed herein may have features that are readily separable from the specific embodiment and that can be combined or substituted in any way with features of any of the other embodiments disclosed herein.

[0019] Regarding the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and are not intended to 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 sequential 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. In addition, any of the aforementioned features or steps may similarly include one or more further features or steps unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," and "back" are used for convenience and do not imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0020] With respect to "proximal," for example, the "proximal portion" or "proximal section" of a medical device includes the portion of the medical device intended to be near the clinician when used on a patient. Similarly, the "proximal length" of a medical device includes the length of the medical device intended to be near the clinician when used on a patient. The "proximal end" of a medical device is the end of the medical device intended to be near the clinician when used on a patient. The proximal portion, section, or length of a medical device may include the proximal end of the medical device. In such cases, the proximal portion, section, or length of a medical device may be further specified as the "proximal end portion," "proximal end section," or "proximal end length" of the medical device. That is, the proximal portion, section, or length of a medical device need not include the proximal end of the medical device. Indeed, unless the context suggests otherwise, a proximal portion, section, or length of a medical device is not a terminal portion, section, or length of the medical device.

[0021] With respect to "distal," for example, a "distal portion" or "distal section" of a medical device includes a portion of the medical device intended to be near or within a patient when the medical device is used with the patient. Similarly, a "distal length" of a medical device includes a length of the medical device intended to be near or within a patient when the medical device is used with the patient. A "distal end" of a medical device is an end of the medical device intended to be near or within a patient when the medical device is used with the patient. A distal portion, section, or length of a medical device may include the distal end of the medical device. In such cases, the distal portion, section, or length of a medical device may be further specified as a "distal end portion," "distal section," or "distal end length" of the medical device. That is, a distal portion, section, or length of a medical device need not include the distal end of the medical device. Indeed, unless the context suggests otherwise, a distal portion, section, or length of a medical device is not the terminal portion, section, or length of the medical device.

[0022] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Again, a treatment field is typically established around a patient using one or more treatment barriers before any medical procedure. For example, a sterile field can be established above or around a patient by draping the patient with a sterile drape. Often, medical procedures require MPU medical devices that cannot be sterilized, and such medical devices are required to be placed under a sterile drape. However, sterile single-patient-use SPU medical devices often need to be functionally connected to an MPU medical device. Some existing solutions rely on intentionally tearing the sterile drape to establish a functional connection between the sterile SPU medical device and the MPU medical device. However, this intentional tearing of the sterile drape carries the risk of contaminating the carefully established sterile field around the patient. Furthermore, establishing some functional connections between a sterile SPU medical device and an MPU medical device can be difficult, especially due to the intentional tearing of the sterile drape. What is needed is a connection system for establishing a safe, routine functional connection between a sterile SPU medical device and an MPU medical device.

[0023] Disclosed herein are connection systems and methods that address the above. For example, the connection system may include a male connector associated with an SPU medical device and a female connector associated with an MPU medical device. The male connector may include a flexible member around the male connector and proximal to the plug of the male connector. The female connector may include a rigid member around the opening of the receptacle of the female connector. The flexible member may be configured to conform to the rigid member with a procedure barrier therebetween when the plug of the male connector is inserted into the receptacle of the female connector. Insertion of the plug of the male connector into the receptacle of the female connector can establish one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device.

[0024] Connected Systems 1-3 illustrate a connection system 100 for establishing one or more functional connections across a procedure barrier 102 between an SPU medical device 104 and an MPU medical device 106, according to some embodiments.

[0025] As shown, the connection system 100 may include a male connector 108 associated with the SPU medical device 104 and a female connector 110 associated with the MPU medical device 106. As described in further detail below, insertion of the male connector 108 into the female connector 110 may establish one or more functional connections across the procedure barrier 102 between the SPU medical device 104 and the MPU medical device 106, thereby maintaining the environment in which each of the SPU medical device 104 and the MPU medical device 106 is located.

[0026] Notably, the aforementioned or primary configuration of the connection system 100 may be reversed in a secondary configuration of the connection system 100, where the male connector 108 is associated with the MPU medical device 106 and the female connector 110 is associated with the SPU medical device 104. However, the primary configuration of the connection system 100 is particularly advantageous when the procedure barrier 102 separates a sterile field including the SPU medical device 104 from a non-sterile field including the MPU medical device 106. This is because the primary configuration of the connection system 100 does not require breaching the sterile field with non-sterile components as is required in the secondary configuration of the connection system 100. In fact, the secondary configuration of the connection system 100 requires breaching a sterile field including the female connector 110 of the SPU medical device 104 with the male connector 108 from a non-sterile field including the male connector 108 and the MPU medical device 106 to establish one or more functional connections.

[0027] The male connector 108 may include a plug 112 and a flexible member 114 that surrounds the male connector 108 and is proximal to the plug 112 . The plug 112 may be configured to be inserted into the receptacle 116 of the female connector 110. Such a plug 112 may be circular, rectangular, trapezoidal, or any other shape having rotational symmetry of C1 or greater in a cross-section of the plug 112. Having the plug 112 circular in its cross-section may be advantageous in that a clinician need not be concerned with a specific rotation of the plug 112 about its central axis to align it with the receptacle 116 of the female connector 110. Thus, having the plug 112 circular in its cross-section is generally associated with establishing a single functional connection that is aligned with the central axes of the plug 112 and the receptacle 116. In contrast, having the plug 112 rectangular, trapezoidal, etc. in its cross-section is generally associated with establishing two or more functional connections that are parallel to the central axes of the plug 112 and the receptacle 116 by aligning a specific rotation of the plug 112 with the receptacle 116 of the female connector 110.

[0028] Flexible member 114 may be fixedly coupled to male connector 108, or flexible member 114 may be removably coupled to male connector 108. Additionally, flexible member 114 may be a flexible disk, although it should be understood that the shape of flexible member 114 is not limited to a disk. Indeed, regardless of whether flexible member 114 has a disk shape or some other shape, flexible member 114 may be configured to conform to rigid member 118 of female connector 110 with procedure barrier 102 therebetween when plug 112 is inserted into receptacle 116. Notably, flexible member 114 may also function as a guard to keep the clinician's hand holding the male connector proximal to the guard, thereby preventing the clinician's hand from crossing from a procedure field, such as a sterile field, to another field, such as a non-sterile field.

[0029] The female connector 110 may include a receptacle 116 and a rigid member 118 around the opening of the receptacle 116 . The receptacle 116 of the female connector 110 may be configured to receive the plug 112 of the male connector 108. Accordingly, the receptacle 116 may similarly be circular, rectangular, trapezoidal, or any other shape having rotational symmetry of C1 or greater in the transverse cross-section of the receptacle 116.

[0030] Rigid member 118 may be fixedly coupled to female connector 110, or rigid member 118 may be removably coupled to female connector 110. Additionally, rigid member 118 may be a rigid bowl that opens away from receptacle 116 of female connector 110. However, it should be understood that rigid member 118 is not limited to a bowl shape. Indeed, regardless of whether rigid member 118 has a bowl shape, a dome shape, or other shape, rigid member 118 may be configured to support flexible member 114 of male connector 108 with procedure barrier 102 therebetween when plug 112 is inserted into receptacle 116.

[0031] Notwithstanding the above, it should be understood that flexible member 114 and rigid member 118 may be interchangeably coupled to either male connector 108 or female connector 110. Indeed, in alternatives to what has been described above, flexible member 114 may be fixedly or removably coupled to female connector 110, and rigid member 118 may be fixedly or removably coupled to male connector 108.

[0032] The male connector 108 and the female connector 110 may be configured relative to one another such that insertion of the plug 112 of the male connector 108 into the receptacle 116 of the female connector 110 magnetically secures the male connector 108 to the female connector 110, mechanically secures the male connector 108 to the female connector 110, or adhesively secures the male connector 108 to the female connector 110. Combinations of the above are also possible. Regardless of whether and how the male connectors 108 and female connectors 110 are secured to one another as described above, insertion of the plug 112 into the receptacle 116 may be configured such that a fluid-tight seal is formed by the flexible member 114 of the male connector 108 lining up with the rigid member 118 of the female connector 110.

[0033] With regard to magnetically securing the male connector 108 to the female connector 110, the male connector 108 may be magnetically secured to the female connector 110 via one or more opposing magnets on each of the flexible member 114 and the rigid member 118.

[0034] With regard to mechanically securing the male connector 108 to the female connector 110, the male connector 108 may be mechanically secured to the female connector 110 via one or more retractable protrusions 120 protruding from an outer wall of the plug 112 of the male connector 108 and one or more corresponding recesses 121 on an inner wall of the receptacle 116 of the female connector 110. Advantageously, the one or more retractable protrusions 120 and the one or more corresponding recesses 121 may be configured to produce an audible click upon insertion of the plug 112 of the male connector 108 into the receptacle 116 of the female connector 110. Such an audible click may be used to indicate that the male connector 108 has been mechanically secured to the female connector 110. In particular, one or more retractable protrusions 120 may be spring-biased to protrude from the outer wall of the plug 112 so as to be retracted by a lever 122 extending from the male connector 108 proximal to the retractable protrusions 120.

[0035] With regard to adhesively securing male connector 108 to female connector 110, male connector 108 may be adhesively secured to female connector 110 via an adhesive on mating surfaces of one or both of flexible member 114 and rigid member 118. Additionally or alternatively, adhesive may be present around plug-shaped holes on one or both sides of a plastic window in procedure barrier 102 interposed between flexible member 114 and rigid member 118.

[0036] When the plug 112 of the male connector 108 is inserted into the receptacle 116 of the female connector 110, one or more functional connections can be established across the treatment barrier 102 between the SPU medical device 104 and the MPU medical device 106. The one or more functional connections are selected from an electrical connection, an optical connection, and a fluid connection.

[0037] The procedure barrier 102 may be a sterile drape (e.g., a polypropylene drape) with a plug-sized hole in the sterile drape's plastic window. The plastic window is placed within the larger window-sized hole in the sterile drape to seal the flexible member 114 and the rigid member 118 to one another. In particular, the plug-shaped hole may be covered with an adhesive pull tab before using the sterile drape. The plastic window may be configured to be positioned between the flexible member 114 of the male connector 108 and the rigid member 118 of the female connector 110. The plug-shaped hole is centered over the receptacle 116 of the female connector 110. Again, each side of the plastic window may include an adhesive thereon. Thus, one or more functional connections may be made across the sterile drape between the SPU medical device 104 and the MPU medical device 106 from a sterile field containing the SPU medical device 104 and a non-sterile field containing the MPU medical device 106.

[0038] method Methods of connection system 100 include methods of using connection system 100. Such methods include at least the step of inserting a male connector 108 associated with an SPU medical device 104 across a procedure barrier 102 into a female connector 110 associated with an MPU medical device 106. As described above, the male connector 108 may include a flexible member 114 around the male connector 108 proximal to a plug 112 of the male connector 108. The female connector 110 may include a rigid member 118 around an opening of a receptacle 116 of the female connector 110. Again, the flexible member 114 may be configured to conform to the rigid member 118 with the procedure barrier 102 between the flexible member 114 and the rigid member 118. Additionally, when the plug 112 of the male connector 108 is inserted into the receptacle 116 of the female connector 110 during the insertion step, one or more functional connections can be established across the treatment barrier 102 between the SPU medical device 104 and the MPU medical device 106.

[0039] Although some specific embodiments are disclosed herein, and 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, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A connection system comprising: a male connector associated with a single patient use (SPU) medical device, the male connector including a flexible member around the male connector, the flexible member being proximal to a plug of the male connector; A connection system comprising: a female connector associated with a multi-patient use (MPU) medical device, the female connector including a rigid member around an opening of a receptacle of the female connector, the flexible member configured to fit along the rigid member with a procedure barrier between the flexible member and the rigid member when the plug of the male connector is inserted into the receptacle of the female connector, thereby establishing one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device.

2. The connection system of claim 1 , wherein the flexible member is fixedly coupled to the male connector.

3. The connection system of claim 1 , wherein the flexible member is removably coupled to the male connector.

4. The connection system of any one of claims 1 to 3, wherein the flexible member is a flexible disk.

5. The connection system of any one of claims 1 to 4, wherein the rigid member is fixedly coupled to the female connector.

6. The connection system of any one of claims 1 to 4, wherein the rigid member is removably coupled to the female connector.

7. 7. The connection system of claim 1, wherein the rigid member is a rigid bowl that opens away from the receptacle of the female connector.

8. 8. The connection system of claim 1, wherein when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is magnetically secured to the female connector via one or more magnets on each of the flexible member and the rigid member.

9. 8. The connection system of claim 1, wherein when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is mechanically secured to the female connector via one or more retractable protrusions extending from the plug of the male connector and one or more corresponding recesses on an inner wall of the receptacle.

10. 10. The connection system of claim 9, wherein upon insertion of the plug of the male connector into the receptacle of the female connector, the one or more retractable protrusions and the one or more corresponding recesses produce an audible click, thereby indicating that the male connector is mechanically secured to the female connector.

11. 8. The connection system of claim 1, wherein when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is adhesively secured to the female connector via adhesive on the mating surfaces of the flexible member and the rigid member.

12. The connection system of any preceding claim, wherein the flexible member conforms to the rigid member to form a fluid-tight seal.

13. The connection system of any one of claims 1 to 12, wherein the one or more functional connections are selected from an electrical connection, an optical connection, and a fluid connection.

14. The connection system of any one of claims 1 to 13, wherein the treatment barrier is a sterile drape such that the one or more functional connections across the treatment barrier between the SPU medical device and the MPU medical device extend from a sterile field containing the SPU medical device and a non-sterile field containing the MPU medical device.

15. 1. A method of a connection system, comprising: A method of connection system comprising inserting a male connector associated with a single-patient use (SPU) medical device across a procedure barrier into a female connector associated with a multi-patient use (MPU) medical device, wherein the male connector includes a flexible member around the male connector, the flexible member being proximal to a plug of the male connector, and the female connector includes a rigid member around an opening of a receptacle of the female connector, the flexible member being configured to fit along the rigid member with the procedure barrier between the flexible member and the rigid member, thereby establishing one or more functional connections across the procedure barrier between the SPU medical device and the MPU medical device.

16. 16. The method of claim 15, wherein the flexible member is a flexible disk fixedly or removably coupled to the male connector.

17. 17. The method of claim 15 or 16, wherein the rigid member is a rigid bowl fixedly or removably coupled to the female connector, the rigid bowl opening away from the receptacle of the female connector.

18. 18. The method of any one of claims 15 to 17, wherein when the plug of the male connector is inserted into the receptacle of the female connector, the male connector is magnetically, mechanically or adhesively secured to the female connector, and the flexible member conforms to the rigid member, thereby forming a fluid-tight seal.

19. The method of any one of claims 15 to 18, wherein the one or more functional connections are selected from electrical connections, optical connections, and fluid connections.

20. The method of any one of claims 15 to 19, wherein the treatment barrier is a sterile drape such that the one or more functional connections across the treatment barrier between the SPU medical device and the MPU medical device extend from a sterile field containing the SPU medical device and a non-sterile field containing the MPU medical device.

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