CN-122028868-A - Protective cover for reusable hand-held instrument

Abstract

A sterile adapter is provided for electrically coupling a conductive wire of a medical device to an electrical port of a handheld instrument. The sterile adapter includes a sterile sleeve sized to removably receive a handheld instrument, a hub assembly secured to the sterile sleeve for receiving a proximal end of a conductive wire of a medical device, and a conductive shaft secured to the hub assembly and received within the sterile sleeve. The conductive shaft has a distal end secured to the hub assembly and a proximal end configured for insertion into an electrical port of a handheld instrument. The conductive shaft has a lumen in which a proximal end of the conductive wire of the medical device is slidably disposed when received by the hub assembly.

Inventors

• Josh Lazar
• Lai Yuyou
• Terra Engo
• Brandon Cohen

Assignees

• 斯瑞克公司
• 史赛克欧洲运营有限公司

Dates

Publication Date

20260512

Application Date

20240809

Priority Date

20230816

Claims (20)

1. 1. A sterile adapter for electrically coupling a conductive wire of a medical device to an electrical port of a handheld instrument, the sterile adapter comprising: A sterile sleeve sized to removably receive the handheld instrument; a hub assembly secured to the sterile sleeve for receiving a proximal end of the conductive wire of the medical device, and A conductive shaft secured to the hub assembly and received within the sterile sleeve, the conductive shaft having a distal end secured to the hub assembly and a proximal end configured for insertion into the electrical port of the handheld instrument, the conductive shaft having a lumen in which the proximal end of the conductive wire of the medical device is slidably disposed when received by the hub assembly.
2. 2. The sterile adapter of claim 1, wherein the sterile sleeve is optically transparent.
3. 3. The sterile adapter of claim 1, wherein the sterile sleeve has a sealable opening into which the hand-held instrument is insertable and from which the hand-held instrument is removable.
4. 4. The sterile adapter of claim 1, further comprising a clamping mechanism secured to the sterile sleeve, the clamping mechanism configured for clamping the handheld instrument when the handheld instrument is received in the sterile sleeve.
5. 5. The sterile adapter of claim 1, wherein the hub assembly comprises a hub secured to the sterile sleeve, and a Rotary Hemostatic Valve (RHV) secured to the rotary hemostatic valve for reversibly securing the conductive wire of the medical device relative to the hub.
6. 6. The sterile adapter of claim 1, wherein the conductive shaft is a hypotube.
7. 7. The sterile adapter of claim 1, wherein the lumen of the conductive shaft is closed at a proximal end of the conductive shaft.
8. 8. The sterile adapter of claim 7, wherein the proximal end of the conductive shaft has a conductive epoxy cap.
9. 9. The sterile adapter of claim 1, wherein the electrically conductive shaft has a proximal shaft portion, a distal shaft portion, and an electrically insulating element disposed between the proximal shaft portion and the distal shaft portion.
10. 10. The sterile adapter of claim 9, wherein the proximal shaft portion is a proximal hypotube and the second shaft portion is a distal hypotube, wherein one of the proximal hypotube and the distal hypotube is partially inserted into the other of the proximal hypotube and the distal hypotube to form an overlap region, and wherein the electrically insulating element is an electrically insulating layer disposed between and spanning the overlap region of the proximal hypotube and the distal hypotube.
11. 11. A medical kit, comprising: a medical device comprising a conductive wire; a hand-held instrument comprising an electrical port having at least one electrical terminal, and A sterile adapter includes a sterile sleeve sized to removably receive the handheld instrument, a hub assembly attached to the sterile sleeve for receiving a proximal end of the conductive wire of the medical device, and a conductive shaft secured to the hub assembly and housed within the sterile sleeve, the conductive shaft having a distal end secured to the hub assembly and a proximal end configured to be inserted into the electrical port of the handheld instrument such that the at least one electrical terminal of the handheld instrument electrically contacts the conductive shaft, the conductive shaft having a lumen in which the proximal end of the conductive wire of the medical device is slidably disposed when received by the hub assembly such that the conductive wire is electrically coupled to the at least one electrical terminal of the handheld instrument via the conductive shaft of the sterile adapter.
12. 12. The medical kit of claim 11, wherein the medical device is a vascular occlusion assembly comprising a vascular occlusion device electrolytically attached to a distal end of the conductive wire, and wherein the handheld instrument is a handheld electrolytic separation device.
13. 13. The medical kit of claim 11, wherein the handheld instrument comprises at least one control device for delivering electrical current to the medical device via the at least one electrical terminal, and wherein the sterile sleeve is optically transparent.
14. 14. The medical kit of claim 11, wherein the sterile sleeve has a sealable opening into which the handheld instrument is insertable and from which the handheld instrument is removable.
15. 15. The medical kit of claim 11, wherein the sterile adapter further comprises a clamping mechanism secured to the sterile sleeve, the clamping mechanism configured for clamping the handheld instrument when the handheld instrument is received within the sterile sleeve.
16. 16. The medical kit of claim 11, wherein the hub assembly comprises a hub secured to the sterile sleeve, and a Rotary Hemostatic Valve (RHV) secured to the hub for reversibly securing the conductive wire of the medical device relative to the hub.
17. 17. The medical kit of claim 11, wherein the conductive shaft is a hypotube.
18. 18. The medical kit of claim 11, wherein the lumen of the conductive shaft is closed at a proximal end of the conductive shaft.
19. 19. The medical kit of claim 18, wherein the proximal end of the conductive shaft has a conductive epoxy cap.
20. 20. The medical kit of claim 11, wherein the at least one electrical terminal of the handheld instrument comprises a power terminal disposed in the electrical port, wherein the medical device comprises a power terminal disposed on the conductive wire, and wherein the sterile adapter comprises a power terminal disposed on the conductive shaft such that when a proximal end of the conductive wire is inserted into the lumen of the conductive shaft of the sterile adapter, the power terminal of the medical device electrically contacts the power terminal of the sterile adapter, and such that when a proximal end of the conductive shaft of the sterile adapter is inserted into the electrical port of the handheld instrument, the power terminal of the handheld instrument electrically contacts the power terminal of the sterile adapter.

Description

Protective cover for reusable hand-held instrument Technical Field The present disclosure relates generally to medical devices and, more particularly, to a sterile barrier for isolating a reusable handheld instrument from a sterile medical device. Background During medical procedures that require introduction of a sterile medical device through an opening in a patient (e.g., a minimally invasive opening or a surgical opening), it is desirable to maintain a sterile field around the opening into which the medical device is to be introduced. For example, in a typical medical procedure, a sterile barrier (e.g., a sterile drape) is placed over a patient to establish a sterile field for introducing a medical device into the patient. However, it is often desirable to break the sterile barrier to form an electrical connection between the sterile medical device and the handheld instrument to transfer electrical energy or electrical communication to and/or from the sterile medical device without compromising the sterility of the sterile field. For example, in one medical procedure, a vaso-occlusive device (e.g., a vaso-occlusive coil, such as that described in U.S. Pat. No. 4,994,069, expressly incorporated herein by reference) may be introduced intravascularly into a patient and delivered into an aneurysm sac until the aneurysm sac is completely filled with the vaso-occlusive device. A highly desirable means of delivering a vaso-occlusive coil into an aneurysm sac is to employ an electrolytic separation procedure, such as that described in U.S. patent No. 5,122,136, which is expressly incorporated herein by reference. After loading an electrically conductive delivery wire (e.g., comprised of stainless steel) with an attached vaso-occlusive coil into a delivery catheter that was previously intravascularly introduced into a patient and advancing the delivery wire distally to insert the vaso-occlusive coil into an aneurysm sac, such electrolytic detachment procedures involve severing the vaso-occlusive coil from the distal end of the delivery wire by applying a small electrical current through the delivery wire to an electrolytically severable joint between the vaso-occlusive coil and the distal end of the delivery wire, thereby permanently delivering the detached vaso-occlusive coil into the aneurysm sac. A hand-held electrolytic separation device (such as InZone cube separation system manufactured by Stryker Neurovascular) may be employed to deliver a small current to the electrolytically severable joint between the vaso-occlusive coil and the distal end of the delivery wire and detect and report separation of the vaso-occlusive coil from the delivery wire. One embodiment of such a handheld electrolytic separation device includes a wire insertion port into which a proximal end of a delivery wire may be inserted for delivering electrical current to an electrolytically severable joint in either a monopolar or bipolar arrangement. In a monopolar arrangement, the handheld electrolytic separation device includes a power terminal to which a proximal end of the delivery wire is coupled and a ground terminal to which a ground electrode placed in contact with (e.g., percutaneously inserted into) a patient is coupled via an electrical cable (e.g., inserted into a ground port via a connector of the electrical cable), while in a bipolar arrangement, the handheld electrolytic separation device includes a power terminal and a ground terminal to which a proximal end of the delivery wire is coupled. The electrolytic detachment device may be manipulated (e.g., by depressing a button) on a handle to perform one or more electrolytic detachment cycles (i.e., to deliver one or more current cycles) on the electrolytically severable joint between the vaso-occlusive coil and the distal end of the delivery wire. A handheld instrument, such as a handheld electrolytic separation device, that is proximally connected to a sterile medical device for introduction into a patient's body may be designed to be disposable (single use) or reusable. Of course, single use hand-held instruments add very high fixed costs to each medical procedure and are discarded after each use, resulting in global waste generation and thus are not optimal. In contrast, reusable hand-held instruments must be sterilized prior to each use and, therefore, must be made very durable to withstand repeated sterilization cycles, thereby increasing substantial manufacturing costs. Furthermore, thorough and proper sterilization of reusable hand-held instruments requires special care and is therefore a time-consuming operation. Moreover, adequate sterilization of the reusable hand-held instrument is not ensured, especially if such reusable hand-held instrument has a working channel or other such difficult to clean portion, such as a wire insertion port of a hand-held electrolytic separation device. To eliminate the need for sterilization of the reusable instrument, some manufacturers