Protective sleeve for conduit cable

Abstract

A protective sleeve for protecting an electrophysiological cable from spatter of blood and fluid, the sleeve including a distal member having a first through-hole, a proximal member having a second through-hole, and an elongate flexible tubular member between the distal member and the proximal member through which the cable may extend. When used with a catheter control handle, the sleeve may assume a stored configuration and a deployed configuration. The sleeve may be stored in and deployed from the proximal end of the control handle. When the cable is connected to the catheter control handle, the sleeve may also be stored separately from the control handle and mounted to the catheter control handle to extend over the cable for deployment. The sleeve may be readily handled with a catheter control handle intended for single use.

Description

Technical Field

[0001] The present invention relates to electrophysiology catheters, and in particular to electrophysiology catheters for use with cables for relaying signals and power. Background Art

[0002] Arrhythmias are irregular beatings of the heart caused by abnormal electrical signals. Arrhythmias can reduce quality of life and increase the risk of stroke and heart failure. Arrhythmias can be located and identified via diagnostic catheters. These catheters can be used to create electroanatomical maps to help electrophysiologists understand lesions and plan and deliver treatments, which may include ablation via therapeutic catheters.

[0003] Conventional electrophysiology (EP) catheters, whether diagnostic or therapeutic, are connected to advanced imaging systems that utilize electromagnetic technology to create real-time three-dimensional (3D) maps of the patient's cardiac structure. The system is designed to help electrophysiologists navigate the heart by generating accurate 3D maps and pinpointing the exact position and orientation of the catheter in the heart during diagnostic and therapeutic procedures. The system includes hardware and software modules that provide various features and functions, including delivering power and ablation energy to the catheter and processing signals sensed and relayed by the catheter via a cable that connects the catheter to the system. When the catheter is introduced into the patient's vascular system, blood and other body fluids can splash from the entry point onto nearby devices and equipment. However, catheters are designed and manufactured for disposal after a single use, and cables are intended to be reused between patients or between procedures, and therefore require sterilization, which is a process of exposing the cable to harsh treatments (including, intense heat or chemicals) that can degrade the cable.

[0004] Applicants have therefore recognized a need to provide a cable with splash proof barrier and protection through the use of a disposable protective sleeve that can be easily installed onto or conveniently stored in a catheter control handle and easily deployed to extend over a cable connected to the catheter control handle. Summary of the invention

[0005] In some embodiments, a sleeve for providing splash protection for a reusable cable connected to a medical probe or catheter intended for single use includes a distal member having a first through hole, a proximal member having a second through hole, and an elongated flexible tubular member including a distal end attached to the distal member and a proximal end attached to the proximal member. The tubular member includes a channel through which the cable extends. The channel is in communication with the first through hole at the distal end and in communication with the second through hole at the proximal end.

[0006] In some embodiments, the distal member of the sleeve is configured for attachment to a catheter control handle.

[0007] In some embodiments, the distal member and the proximal member of the sleeve are releasably coupled to each other.

[0008] In some embodiments, the sleeve further comprises a releasable adhesive between the distal member and the proximal member.

[0009] In some embodiments, the distal member includes a threaded distal portion that is received in the proximal end of the catheter control handle.

[0010] In some embodiments, the tubular member is comprised of a flexible thin plastic film.

[0011] In some embodiments, the tubular member is fluid-tight.

[0012] In some embodiments, each of the distal member and the proximal member has a generally circular cross-sectional configuration.

[0013] In some embodiments, a protective sleeve configured for use with a catheter control handle includes an elongated tubular member including a distal end, a proximal end, and a flexible body portion between the distal end and the proximal end. The distal end is attached to the control handle, and the proximal end and the body portion extend proximally from the catheter control handle.

[0014] In some embodiments, the sleeve further includes a resilient ring member extending circumferentially around the distal end of the sleeve and the control handle.

[0015] In some embodiments, the distal end of the tubular member includes a portion that is wedged into a slot provided in the control handle.

[0016] In some embodiments, the tubular member is comprised of a flexible thin plastic film.

[0017] In some embodiments, a catheter control handle for use with a cable includes a distal end electrical connector and a housing having a longitudinal axis and a proximal end extending circumferentially around the electrical connector relative to the longitudinal axis. Also included is an elongated sleeve having a distal end, a proximal end, and a flexible tubular portion between the distal end and the proximal end, wherein the distal end of the sleeve is attached to the proximal end of the catheter control handle, and the sleeve is configured to assume an expanded configuration when the cable is attached to the catheter control handle, and to assume a stored configuration when the cable is detached from the catheter control handle.

[0018] In some embodiments, the stored configuration includes the tubular portion of the sleeve collapsed within the proximal end of the housing.

[0019] In some embodiments, the expanded configuration includes the proximal end of the sleeve and the tubular portion extending proximally from the control handle.

[0020] In some embodiments, the electrical connector is configured to connect to a cable, and the sleeve in the expanded configuration includes a tubular portion of the sleeve extending over at least a distal portion of the cable and a proximal end.

[0021] In some embodiments, the proximal end includes an inner surface to which the distal end of the elongated sleeve is attached.

[0022] In some embodiments, the sleeve comprises a flexible thin plastic film construction material.

[0023] In some embodiments, a sleeve for use with a cable configured to be attached to a connector cable extending from a catheter includes an elongated tubular member including a distal end, a proximal end, and an intermediate portion extending between the distal end and the proximal end. The distal end of the tubular member is attached to the proximal end of the connector cable, which is attached to a control handle of the catheter at its distal end, such that when the distal end of the cable is connected to the proximal end of the connector cable, the proximal end and the intermediate portion of the elongated tubular member extend proximally over the cable.

[0024] In some embodiments, the sleeve comprises a flexible thin plastic film construction material. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] These and other features and advantages of embodiments of the present invention will be better understood by referring to the following detailed description when considered in conjunction with the accompanying drawings. It should be understood that selected structures and features are not shown in certain drawings in order to provide a better view of the remaining structures and features.

[0026] Figure 1 is a top plan view of a protective sleeve covering a cable connected to a catheter control handle according to one embodiment.

[0027] Figure 2 is a perspective view of a protective sleeve in a deployed configuration extending proximally from a proximal end of a catheter control handle according to one embodiment.

[0028] Figure 3 yes Figure 2 A perspective view of a protective sleeve in a storage configuration collapsed within the proximal end of a catheter control handle.

[0029] Figure 4A is a top plan view of a protective sleeve in a stored configuration with a proximal ring member positioned on a proximal end of a catheter control handle according to one embodiment.

[0030] Figure 4B is in the expanded configuration Figure 4AA top plan view of a protective sleeve of the invention is shown, wherein the proximal ring member and the protective sleeve extend over a cable connected to a catheter control handle.

[0031] Figure 4C is a top plan view of a protective sleeve in an expanded configuration and a proximal ring member having a threaded distal portion according to one embodiment.

[0032] Figure 5 is a perspective view of a protective sleeve with a distal end mounted on an outer surface of a catheter control handle according to one embodiment.

[0033] Figure 6 is a perspective view of a protective sleeve according to another embodiment, the distal end of the protective sleeve being mounted on an outer surface of a catheter control handle.

[0034] Fig. 7A is a perspective view of a protective sleeve according to yet another embodiment, the distal end of the protective sleeve being mounted on an outer surface of a catheter control handle.

[0035] Figure 7B yes Fig. 7A Detailed view of the catheter handles.

[0036] Fig. 8A is a side elevation view of a sleeve having distal and proximal members releasably adhered to one another.

[0037] Figure 8B yes Fig. 8A A side elevation view of a sleeve with the distal member and the proximal member disengaged from each other.

[0038] Figure 8C yes Figure 8B A cross-sectional view of a sleeve.

[0039] Fig.8D is a top plan view of a catheter control handle configured to be used with Fig. 8A , Figure 8B and Figure 8C to provide a splash shield for the cable connected to the catheter control handle.

[0040] Fig. 9 is a top plan view of a conduit having an electrical connector cable to which a sleeve and an electrical cable protected by the sleeve are attached.

[0041] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0043] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a value range of ±20% of the recited value, for example, "about 90%" can refer to a value range of 71% to 99%. In addition, as used herein, the terms "patient", "host", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

[0044] Reference Figure 1 and Figure 2 , the electrophysiology catheter 10 includes an elongated shaft 12, a distal end effector 14, and a control handle 16. The control handle 16 has a longitudinal axis LA defined by its length and is configured to be connected to a cable 20, which includes a distal connector 20D, a proximal connector 20P, and an elongated cable body 20B extending between the distal connector and the proximal connector. In some embodiments, the control handle 16 has a housing 22, the housing 22 has a proximal end 22P, and the proximal end 22P has a circumferential wall 22W relative to the longitudinal axis LA. The wall 22W has an inner surface 26 and a proximal opening 32, the inner surface 26 defines a cavity 30, and the proximal opening 32 provides access to an electrical connector 28 located in the cavity 30. The electrical connector 28 having a pin 28P and a socket 28S is configured to be connected to the distal connector 20D of the cable 20 having a corresponding socket 20S and a pin 20P. The outer surface 24 of the housing 22 may be formed with one or more lateral extensions or arms 25 to facilitate other connections to the control handle 16 , such as irrigation tubing 30 connected to a luer hub 32 .

[0045] Advantageously, an elongated protective sleeve 40 straddles the cable 20, acting as a splash shield to protect against blood and other body fluids that may leak from the catheter's entry point into the patient's body and otherwise contaminate the cable 20, and require the cable to be sterilized prior to use on another patient or in another procedure. The sleeve 40 has a distal end 40D, a proximal end 40P, and an elongated tubular body 40B extending therebetween. The tubular body 40B has a passageway therethrough, with a distal opening at the distal end 40D and a proximal opening at the proximal end 40P. Figure 1 and Figure 2 In the illustrated embodiment, the distal end 40D of the sleeve 40 is circumferentially attached and attached to the inner surface 26 of the distal wall 22W of the catheter housing, wherein the electrical connector 28 of the control handle 16 extends through the distal opening of the sleeve. When the connector 28 of the control handle 16 is connected to the distal connector 20D of the cable 20, the cable body 20B extends through the tubular body 40B, wherein the tubular body 40B circumferentially surrounds the cable body. The length of the tubular body 40B can be at least comparable to the length of the cable body 20B (e.g., Figure 1 ), if not longer, its length is sufficient to cover the proximal connector 20P (as shown in the solid line in FIG. Figure 1 ).

[0046] The sleeve 40 is configured to assume at least two configurations, namely, Figure 1 and Figure 2 The expanded or deployed configuration shown, and Figure 3 The collapsed or stored configuration is shown. Figure 3 In the storage configuration, the sleeve 40 body is collapsed (e.g., stuffed, folded, or flattened) into a roughly annular or "donut" shape utilizing a through hole adapted in the cavity 30 of the housing 22, wherein the electrical connector 28 of the control handle 16 extends through the through hole so that the electrical connector 28 remains exposed and can be used to connect to the distal connector 20D of the cable 20.

[0047] After the distal connector 20D of the cable 20 is connected to the electrical connector 28, the sleeve body 40B can be unfolded from its attached distal end 40D and extended from the cavity 30, wherein the proximal end 40P is pulled along the cable body 20B toward the proximal connector 20P, into the Figure 1 and Figure 2 After completing the procedure on the patient, the distal connector 20D of the cable 20 can be disconnected from the electrical connector 28 of the control handle 16, and the cable 20 can be pulled out from the proximal end 40P of the sleeve 40 through its proximal end 20P, whereby the catheter 10 together with the attached sleeve 40 can be disposed of as a single unit.

[0048] In some embodiments, sleeve 40 includes a proximal ring member 60, such as Figure 4A and Figure 4B The ring member 60 is attached to and extends circumferentially around the proximal opening of the sleeve 40 and is configured to fit circumferentially on the outer surface 24 of the distal wall 22W, wherein the tubular body 40 is inserted and stored in the cavity 30 of the control handle 16 in an annular or "donut" shape. After the distal connector 20D of the cable 20 is connected to the electrical connector 28 of the control handle 16 through the open center of the ring member 60 and the through hole of the sleeve 40 stored in the cavity 30 in an annular shape, the tubular body 40B can be easily deployed to the deployed configuration by the user sliding the ring member 60 proximally on the cable 20, as shown. Figure 4B As shown by arrow A in FIG.

[0049] In some embodiments, such as Figure 4C As shown, the proximal ring member 60 has a cylindrical threaded distal portion 64 adapted to couple with the threaded inner surface 26 (shown in phantom) at the proximal end 22P of the control handle 16. Prior to use, the threaded distal portion 64 is screwed into the proximal end 22P with the protective sleeve 40 inserted and stored within the cavity 30. To deploy the protective sleeve 40, the user rotates the ring member 60 relative to the control handle 16 to release the ring member 60 from the proximal end 22P, whereupon the user can slide the ring member 60 proximally over the cable 20 to deploy the protective sleeve over the cable 20.

[0050] In the aforementioned embodiments, the distal end of the sleeve 40 is attached to the control handle at or near the interior of the cavity 30 at the proximal end 22P. In other embodiments to be described below, the sleeve 40 is attached to the control handle 16 outside the cavity 30 at its distal end 40D. Figure 5As shown, the distal end 40D of the sleeve 40 is mounted on the outer surface 24 of the control handle housing 22, which has a slot 50 that can be formed, for example, below the arm 25. The user can first connect the cable 20 to the electrical connector 28 of the control handle 16, and then slide the distal opening of the sleeve 40 over the proximal connector 20P of the cable 20, the cable body 20B, and the proximal end 22P of the control handle 16. The user can then pull the distal end 40D toward the slot 50 and wedge the distal end 40D into the slot and anchor the distal end 40D to the control handle housing 22. It should be understood that the sleeve 40 can alternatively be attached to the housing 22 first, and then the distal connector 20D of the cable 20 is passed through the sleeve 40 and connected to the electrical connector 28 of the control handle 16. After the procedure, the distal connector 20D of the cable 20 can be disconnected from the control handle 16, and the sleeve 40 can remain attached to the catheter 10 for disposal as a single unit. Alternatively, the distal end 40D of the sleeve may be pulled and released from the slit 50 to be separated from the control handle 16, whereby the sleeve 40 and the catheter 10 may be disposed of separately from each other.

[0051] like Figure 6 As shown, in some embodiments, the outer surface 24 of the housing 22 of the control handle 16 is configured with a hook 52 to which the distal end 40D of the sleeve 40 can be fastened. The distal end 40D of the sleeve 40 can be configured with a pre-formed hole 54, or the sleeve 40 can be pressed and pierced onto the hook 52 so that the sleeve 40 is fastened to the hook. After the procedure and the cable 20 are disconnected from the control handle 16, the sleeve 40 can remain attached to the catheter 10 for disposal as a single unit. Alternatively, the distal end 40D can be untied from the hook 52 to be separated from the control handle 16 for separate disposal.

[0052] like Fig. 7A and Figure 7B As shown, in some embodiments, the outer surface 24 of the housing 22 is configured to have a circumferential groove 54, which is covered by the distal end 40D of the sleeve 40. An elastic band 58 configured to fit tightly in the groove 54 can be initially positioned (or stored) on the housing 22 between the groove 54 and the arm 25, and then rolled or otherwise repositioned on the distal end 40D to be located in the groove when the distal end 40D of the sleeve 40 is fastened to the housing 22. After the protocol and cable 20 are disconnected from the control handle 16, the sleeve 40 can be kept attached to the catheter 10 by the elastic band 56 to be handled as a single unit. Alternatively, the elastic band 56 can be removed from the groove 54 to release the distal end 40D from the control handle 16 for separate handling of the sleeve 40 and the control handle 16.

[0053] In some embodiments, sleeve 40 assumes a storage configuration that is independent and separate from catheter 10 and a deployed configuration after it is installed on catheter 10. Fig. 8A , Figure 8B and Figure 8C As shown in , the sleeve 40 includes a proximal ring member 60, a tubular body 40B, and a distal ring member 66 having a cylindrical threaded distal portion 68, wherein the proximal end of the tubular body 40 is attached to the proximal ring member 60 (its inner or outer surface), and the distal end of the tubular body 40 is attached to the distal ring member 66 (its inner or outer surface). The distal surface 60D of the proximal ring member 60 includes a releasable adhesive 62 for releasably attaching to the distal ring member 66, wherein the tubular body 40 is collapsed and packed within the interior 80 of each proximal ring member 60 and distal ring member 66.

[0054] like Fig.8D As shown, to install the sleeve 40 on the control handle 16 of the catheter 10, the user can screw the distal threaded insertion portion 68 onto the threaded inner surface 26 of the proximal end 22P of the control handle 16. The user can then connect the distal end 20D of the cable 20 to the electrical connector 28 by passing the distal end 20D through the proximal ring member 60, the tubular body 40, and the distal ring member 66. The user can then disengage the proximal ring member 60 from the distal ring member 66 by breaking the bond of the adhesive 62 and slide the proximal ring member 62 proximally along the cable 20 toward the proximal connector 20P. When disposing, the user can disconnect the distal connector 20D of the cable 20 from the electrical connector 28 of the control handle 16, slide the cable proximally out of the tubular body 40B through the proximal ring member 60, and dispose of the catheter 10 and sleeve 40 joined together.

[0055] It should be understood that the sleeve 40 may also be used to protect the cable 20 connected to the electrical connector cable 90, which is connected to the catheter 10, such as Fig. 9 As shown, it has any or all of the structural elements and embodiments described above.

[0056] Sleeve 40 may be constructed of any suitable fluid-impermeable material, such as a flexible thin plastic film, such as polyethylene.

[0057] The above description has been presented with reference to the currently disclosed embodiments of the present invention. Those skilled in the art to which the present invention pertains will appreciate that changes and modifications may be made to the structures described without intentionally departing from the principles, spirit and scope of the present invention. Any feature or structure disclosed in one embodiment may be incorporated as needed or appropriate to replace or supplement other features of any other embodiment. As will be appreciated by those of ordinary skill in the art, the drawings are not necessarily drawn to scale. Therefore, the above-described specific embodiments should not be interpreted as being suitable only for the precise structures described and illustrated in the drawings, but rather should be interpreted as being consistent with and supporting the following claims, which have a full and fair scope of the present invention.

Claims

1. A sleeve, comprising: a distal member having a first through hole; a proximal member having a second through hole; and A slender flexible tubular member, the slender flexible tubular member including a distal end attached to the distal member and a proximal end attached to the proximal member, the tubular member including a channel therethrough, the channel communicating with the first through hole at the distal end and communicating with the second through hole at the proximal end.

2. The sleeve according to claim 1, wherein The distal member is configured for attachment to a catheter control handle.

3. The sleeve according to claim 1, wherein: The distal member and the proximal member are releasably coupled to each other.

4. The sleeve of claim 1 further comprising a releasable adhesive between the distal member and the proximal member.

5. The sleeve according to claim 1, wherein: The distal member includes a threaded distal portion.

6. The sleeve according to claim 1, wherein: The tubular member is composed of a flexible thin plastic film.

7. The sleeve according to claim 1, wherein: The tubular member is fluid-tight.

8. The sleeve according to claim 1, wherein: Each of the distal member and the proximal member has a generally circular cross-sectional configuration.

9. A protective sleeve configured for use with a catheter control handle, comprising: An elongated tubular member includes a distal end, a proximal end, and a main body portion therebetween, wherein the distal end is configured to be attached to the control handle, and the proximal end and the main body portion are configured to extend proximally from the control handle.

10. The sleeve of claim 9, further comprising a resilient ring member configured to extend circumferentially around the distal end of the sleeve and the control handle.

11. The sleeve according to claim 9, wherein: The distal end of the tubular member includes a portion configured to be wedged into a slot provided in the control handle.

12. The sleeve according to claim 9, wherein: The tubular member is composed of a flexible thin plastic film.

13. A catheter control handle for use with an electrical cable, comprising: a distal end electrical connector; a housing having a longitudinal axis and a proximal end extending circumferentially about the electrical connector relative to the longitudinal axis; A slender sleeve includes a distal end, a proximal end and a tubular portion therebetween, wherein the distal end is attached to the proximal end of the housing, the sleeve being configured to assume an expanded configuration when the cable is attached to the catheter control handle and to assume a stored configuration when the cable is detached from the catheter control handle.

14. The control handle according to claim 13, wherein: The stored configuration includes the tubular portion of the sleeve collapsed within the proximal end of the housing.

15. The control handle according to claim 13, wherein: The expanded configuration includes the proximal end and the tubular portion extending proximally past the control handle.

16. The control handle according to claim 13, wherein: The electrical connector is configured for connection to a cable, and the sleeve in the expanded configuration includes the tubular portion extending proximally over at least a distal portion of the cable and the proximal end.

17. The control handle according to claim 13, wherein: The sleeve comprises a construction material of a flexible thin plastic film.

18. The control handle according to claim 13, wherein: The proximal end includes an inner surface to which the distal end of the elongated sleeve is attached.

19. A sleeve for use with an electrical cable configured for attachment to a connector cable extending from a conduit, the sleeve comprising: A slender tubular member, comprising a distal end, a proximal end, and an intermediate portion extending between the distal end and the proximal end, the distal end being configured for attachment to the proximal end of the connector cable, the connector cable being attached to the control handle of the catheter at its distal end, the proximal end and the intermediate portion of the slender tubular member extending proximally over the cable when the distal end of the cable is connected to the proximal end of the connector cable.

20. The sleeve according to claim 19, wherein The sleeve comprises a construction material of a flexible thin plastic film.

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