Protective jacket for reusable hand-held instrument

Abstract

A sterile adapter is provided for electrically coupling an electrically conductive wire of a medical device to an electrical port of a handheld instrument. In one embodiment, a sterile adapter includes: a sterile cover sized to removably receive a handheld instrument; a seat assembly secured to the sterile sheath for receiving a proximal end of an electrically conductive wire of the medical device; and a conductive shaft fixed to the seat assembly and housed within the sterile sleeve. The conductive shaft has a distal end secured to the seat 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 a conductive wire of the medical device is slidably disposed when received by the seat assembly.

Description

Technical Field

[0001] This disclosure relates generally to medical devices, and more specifically, to a sterile barrier for isolating reusable handheld instruments from sterile medical devices. Background Technology

[0002] During medical procedures requiring the introduction of a sterile medical device through an opening within the patient's body (e.g., a minimally invasive opening or a surgical opening), it is desirable to maintain a sterile zone around the opening into which the medical device will be introduced. For example, in routine medical procedures, a sterile barrier (e.g., a sterile drape) is placed on the patient to establish a sterile zone for the introduction of the medical device. However, it is often necessary to disrupt the sterile barrier to establish an electrical connection between the sterile medical device and a handheld instrument, thereby transmitting electrical energy or electrical communication to and / or from the sterile medical device without compromising the sterility of the sterile zone.

[0003] For example, in a medical procedure, a vascular occlusion device (such as a vascular occlusion coil, as described in U.S. Patent No. 4,994,069, which is expressly incorporated herein by reference) can be introduced intravascularly into the patient and delivered into the aneurysm sac until the aneurysm sac is completely filled with the vascular occlusion device. A highly desirable method for delivering a vascular occlusion coil into the aneurysm sac is by electrolysis, such as that described in U.S. Patent No. 5,122,136, which is expressly incorporated herein by reference. After loading a conductive delivery line (e.g., made of stainless steel) and an attached vascular occlusion coil into a delivery catheter previously introduced into the patient's body within a blood vessel and advancing the delivery line distally to insert the vascular occlusion coil into the aneurysm sac, this electrolytic dissection procedure involves disconnecting the vascular occlusion coil from the distal end of the delivery line by applying a small current via the delivery line to an electrolytically disconnectable joint between the vascular occlusion coil and the distal end of the delivery line, thereby permanently delivering the dissected vascular occlusion coil into the aneurysm sac.

[0004] A handheld electrolytic disconnect device (such as the InZone® disconnect system manufactured by Stryker® Neurovascular) can be used to deliver a small current to an electrolytically disconnectable connector between the occlusion coil and the distal end of the delivery line, and to detect and report the disconnection of the occlusion coil from the delivery line. One embodiment of such a handheld electrolytic disconnect device includes a wire insertion port into which the proximal end of the delivery lead can be inserted to deliver current to the electrolytically disconnectable connector in either a unipolar or bipolar arrangement. In a unipolar arrangement, the handheld electrolytic disconnect device includes a power terminal and a ground terminal, the proximal end of the delivery line being coupled to the power terminal, and a ground electrode positioned for contact with the patient (e.g., inserted transdermally) being coupled to the ground terminal via an electrical cable (e.g., inserted into a ground port via an electrical cable connector). In a bipolar arrangement, the handheld electrolytic disconnect device includes a power terminal and a ground terminal, the proximal end of the delivery line being coupled to both the power terminal and the ground terminal. The handheld electrolytic separation device can be operated on the handle (e.g., by pressing a button) to perform one or more electrolytic separation cycles (i.e., deliver one or more current cycles) on the electrolytically disconnectable joint between the vascular occlusion coil and the distal end of the delivery line.

[0005] Handheld instruments (such as handheld electrolysis devices) that connect proximally to sterile medical devices for introduction into the patient can be designed as disposable (single-use) or reusable. Single-use handheld instruments, of course, add a very high fixed cost to each medical procedure and are discarded after each use, contributing to global waste and are therefore not optimal. In contrast, reusable handheld instruments must be sterilized before each use and therefore must be made very durable to withstand repeated sterilization cycles, adding considerable manufacturing costs. Furthermore, thorough and proper sterilization of reusable handheld instruments requires particular care and is therefore a time-consuming operation. Moreover, adequate sterilization of reusable handheld instruments cannot be guaranteed, especially if such instruments have working channels or other difficult-to-clean parts, such as the wire insertion port of a handheld electrolysis device.

[0006] To eliminate the need for sterilizing reusable instruments, some manufacturers offer inexpensive sterile covers that completely enclose the reusable instrument, thus isolating it from the associated sterile medical device introduced into the patient. In these cases, the need for sterilization of the reusable instrument is eliminated. However, isolating the reusable instrument from the sterile medical device becomes more complex when it directly interfaces with the device, requiring electrical connection through the sterile cover. Additional difficulties may arise when reusable handheld instruments (such as handheld electrolysis devices) have one or more controls that require access by healthcare personnel.

[0007] Therefore, there remains a need for an effective means of isolating reusable handheld instruments from sterile medical devices that require electrical connections between them. Summary of the Invention

[0008] According to one aspect of the invention, a sterile adapter is provided for electrically connecting the conductive wires of a medical device to an electrical port of a handheld instrument.

[0009] The sterile adapter includes a sterile sleeve sized to removably accommodate a handheld instrument. In one embodiment, the sterile sleeve is optically transparent. In another embodiment, the sterile sleeve has a sealable opening into which the handheld instrument can be inserted and removed. In an optional embodiment, the sterile adapter further includes a clamping mechanism secured to the sterile sleeve. The clamping mechanism is configured to clamp the handheld instrument when it is accommodated within the sterile sleeve.

[0010] The sterile adapter also includes a hub assembly that is attached to a sterile sleeve for receiving the proximal end of a conductive wire from a medical device. In one embodiment, the hub assembly includes: a seat attached to a sterile sleeve; and a rotary hemostatic valve (RHV) attached to the seat for reversibly securing the conductive wire of the medical device relative to the seat.

[0011] The sterile adapter also includes a conductive shaft (e.g., a hypotube) that is secured to the base assembly and housed within a sterile sleeve. The conductive shaft has a distal end secured to the base assembly and a proximal end configured for insertion into an electrical port of a handheld instrument. The conductive shaft has a lumen in which the proximal end of the conductive wire of the medical device is slidably disposed when received by the base assembly. In one embodiment, the lumen of the conductive shaft is closed at the proximal end of the conductive shaft, and the proximal end of the conductive shaft has a conductive epoxy cap. In another embodiment, the conductive shaft has a proximal shaft portion, a distal shaft portion, and an electrical insulating element disposed between the proximal and distal shaft portions. In this embodiment, the proximal axis portion can be a proximal thiocyanate tube, the second axis portion can be a distal thiocyanate tube, one of the proximal thiocyanate tube and the distal thiocyanate tube can be partially inserted into the other of the proximal thiocyanate tube and the distal thiocyanate tube to form an overlapping area, and the electrical insulating element can be an electrical insulating layer disposed between the proximal thiocyanate tube and the distal thiocyanate tube and spanning the overlapping area of ​​the proximal thiocyanate tube and the distal thiocyanate tube.

[0012] According to a second aspect of the invention, a medical kit includes: a medical device including a conductive wire; and a handheld instrument including an electrical port having at least one electrical terminal. In one embodiment, the medical device is a vascular occlusion assembly including a vascular occlusion device electrolytically attached to the distal end of the conductive wire, and the handheld instrument is a handheld electrolytic separation device.

[0013] The medical kit also includes a sterile adapter comprising a sterile sleeve sized to removably accommodate a handheld instrument. In one embodiment, the handheld instrument may include at least one control device for supplying current to the medical device via one or more electrical terminals, in which case the sterile sleeve may be optically transparent. In another embodiment, the sterile sleeve has a sealable opening into which the handheld instrument can be inserted and removed. In an optional embodiment, the sterile adapter further includes a clamping mechanism secured to the sterile sleeve. The clamping mechanism is configured to clamp the handheld instrument when it is accommodated within the sterile sleeve.

[0014] The sterile adapter also includes a socket assembly secured to a sterile sleeve for receiving the proximal end of a conductive wire from a medical device. In one embodiment, the socket assembly includes: a seat secured to a sterile sleeve; and an RHV to which the seat is secured, the RHV being used to reversibly secure the conductive wire of the medical device relative to the seat.

[0015] The sterile adapter also includes a conductive shaft (e.g., a hypotube) that is secured to the base assembly and housed within a sterile sleeve. The conductive shaft has a distal end secured to the base assembly and a proximal end configured for insertion into an electrical port of a handheld instrument, such that one or more electrical terminals of the handheld instrument electrically contact the conductive shaft. The conductive shaft has a lumen in which the proximal end of a conductive wire of the medical device is slidably disposed when received by the base assembly, such that the conductive wire is electrically connected via the conductive shaft of the sterile adapter to one or more electrical terminals of the handheld instrument. In one embodiment, the lumen of the conductive shaft is closed at the proximal end of the conductive shaft, and the proximal end of the conductive shaft has a conductive epoxy cap. In another embodiment, the conductive shaft has a proximal shaft portion, a distal shaft portion, and an electrically insulating element disposed between the proximal and distal shaft portions. In this embodiment, the proximal axis portion is a proximal thiocyanate tube, the second axis portion is a distal thiocyanate tube, one of the proximal thiocyanate tube and the distal thiocyanate tube is partially inserted into the other of the proximal thiocyanate tube and the distal thiocyanate tube to form an overlapping region, and the electrical insulating element is an electrical insulating layer disposed between the proximal thiocyanate tube and the distal thiocyanate tube and spanning the overlapping region of the proximal thiocyanate tube and the distal thiocyanate tube.

[0016] In one embodiment, one or more electrical terminals of the handheld instrument include a power terminal disposed in an electrical port, the medical device includes a power terminal disposed on a conductive wire, and the sterile adapter includes a power terminal disposed on a conductive shaft, such that when the 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 the 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. In this embodiment, one or more electrical terminals of the handheld instrument may further include a ground terminal, the medical device may further include a ground terminal disposed on the conductive wire, and the sterile adapter may further include a ground terminal disposed on the conductive shaft, such that when the proximal end of the conductive wire is inserted into the lumen of the conductive shaft of the sterile adapter, the ground terminal of the medical device electrically contacts the ground terminal of the sterile adapter, and such that when the proximal end of the conductive shaft of the sterile adapter is inserted into the electrical port of the handheld instrument, the ground terminal of the handheld instrument electrically contacts the ground terminal of the sterile adapter.

[0017] In this embodiment, the conductive wire of the vascular occlusion assembly may include a first proximal shaft portion, a first distal shaft portion, and a first electrical insulating element disposed between the first proximal shaft portion and the first distal shaft portion, thereby forming a power supply terminal and a ground terminal of the vascular occlusion assembly. The conductive shaft of the sterile adapter may include a second proximal shaft portion, a second distal shaft portion, and a second electrical insulating element disposed between the second proximal shaft portion and the second distal shaft portion, thereby forming a power supply terminal and a ground terminal of the sterile adapter. The first proximal shaft portion may be a first proximal subhose tube, the first distal shaft portion may be a first distal subhose tube, one of the first proximal subhose tube and the first distal subhose tube may be partially inserted into the other of the first proximal subhose tube and the first distal subhose tube to form an overlapping region, the first electrical insulating element may be a first electrical insulating layer disposed between the first proximal subhose tube and the first distal subhose tube and spanning the overlapping region of the first proximal subhose tube and the first distal subhose tube, and the second proximal shaft portion may be a second proximal subhose tube, the second distal shaft portion may be a second distal subhose tube, one of the second proximal subhose tube and the second distal subhose tube may be partially inserted into the other of the second proximal subhose tube and the second distal subhose tube to form an overlapping region, and the second electrical insulating element may be a second electrical insulating layer disposed between the second proximal subhose tube and the second distal subhose tube and spanning the overlapping region of the second proximal subhose tube and the second distal subhose tube.

[0018] Other and further aspects and features of the embodiments will become apparent from the following detailed description taken in conjunction with the accompanying drawings. Attached Figure Description

[0019] The accompanying drawings illustrate the design and practicality of preferred embodiments of the disclosed invention, in which similar elements are denoted by the same reference numerals. It should be noted that the drawings are not drawn to scale, and throughout the drawings, elements having similar structures or functions are denoted by the same reference numerals. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. Furthermore, the illustrated embodiments of the disclosed invention do not need to possess all the aspects or advantages shown. Moreover, the aspects or advantages described in connection with the specific embodiments of the disclosed invention are not necessarily limited to that embodiment and can be practiced in any other embodiment, even if these embodiments are not shown.

[0020] To better understand how the above and other advantages and objectives of the disclosed invention are achieved, a more specific description of the disclosed invention, briefly described above, will be presented by reference to its specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. The invention will be described and explained using the drawings in conjunction with additional features and details, in which: Figure 1 This is a plan view of a vascular occlusion treatment system constructed according to one embodiment of the disclosed invention, specifically showing the vascular occlusion device in a delivery configuration. Figure 2 yes Figure 1 A plan view of a vascular occlusion treatment system, specifically showing the vascular occlusion device in a deployment configuration; Figure 3 yes Figure 1 An enlarged and partially sectional cross-section of a portion of the vascular occlusion component of a vascular occlusion treatment system; Figure 4 yes Figure 1 A top view of the handheld electrolytic separation device of the vascular occlusion treatment system; Figure 5 yes Figure 1 A top view of the sterile adapter of the vascular occlusion treatment system; Figure 6A yes Figure 5 A front view of the sterile sleeve of the sterile adapter, specifically showing the opening of the sterile sleeve in the open position; Figure 6B yes Figure 5 A front view of the sterile sleeve of the sterile adapter, specifically showing the opening of the sterile sleeve when it is in a closed and sealed state; Figure 7 yes Figure 1 A cross-sectional view of the proximal end of the bipolar core wire of the vascular occlusion component of the vascular occlusion treatment system, which is inserted into... Figure 5 Inside the bipolar conductive sleeve of the sterile adapter; Figure 8 yes Figure 1 A cross-sectional view of the proximal end of the monopolar core wire of the vascular occlusion component in a vascular occlusion treatment system, wherein the proximal end is inserted... Figure 5 The sterile adapter's unipolar conductive sleeve; Figure 9 yes Figure 5 One embodiment of the sterile adapter is specifically illustrated for use with Figure 4 The optional clamping mechanism of the electrolytic separation device; and Figure 10 yes Figure 5Another embodiment of the sterile adapter is specifically shown for use with Figure 4 Another optional clamping mechanism for the electrolytic separation device. Detailed Implementation

[0021] This disclosure relates to a sterile adapter that physically isolates a handheld instrument from a sterile medical device with conductive wires, while providing an electrical connection between the handheld instrument and the sterile medical device. By physically isolating the handheld instrument from the sterile environment, the handheld instrument can be reused between medical procedures (instead of being discarded after use) without the risk of cross-contamination. The sterile adapter includes: a sterile sleeve sized to accommodate the handheld instrument therein; a seat assembly secured to the sterile sleeve for receiving the proximal end of the conductive wires of the sterile medical device; and a conductive shaft housed within the sterile sleeve.

[0022] The conductive shaft has a distal end, fixed to a base assembly, and a proximal end, configured for insertion into an electrical port of a handheld device when housed within a sterile sleeve, such that the proximal end of the conductive shaft electrically contacts a power terminal within the electrical port of the handheld device. The conductive shaft of the sterile adapter has a lumen in which the proximal end of the conductive wire can be slidably disposed after being received by the base assembly, such that the conductive wire of the medical device makes electrical contact with the conductive shaft and is thus electrically connected via the conductive shaft to the power terminal of the handheld device. In this manner, the sterile sleeve of the sterile adapter physically isolates the handheld device from the sterile medical device (which resides in a sterile environment), while allowing medical personnel to operate one or more controls on the handheld device and visualize signals from any indicators without disrupting the sterile area, and simultaneously the base assembly and conductive shaft of the sterile adapter facilitate electrical connection between the sterile medical device and the handheld device without disrupting the sterile area.

[0023] Handheld instruments and medical devices can be inherently bipolar. In this case, the electrical port of the handheld instrument can have both a power terminal and a ground terminal. The conductive wire of the medical device can have a proximal wire portion, a distal wire portion, and an electrically insulating element disposed therebetween. The conductive shaft of the sterile adapter is designed to mimic the electrical characteristics of bipolar conductive wires and therefore can have a proximal shaft portion, a distal shaft portion, and an electrically insulating element disposed therebetween. When the proximal end of the conductive shaft of the sterile adapter is inserted into the electrical port of the handheld instrument, the proximal shaft portion electrically contacts one of the power terminal and the ground terminal of the handheld instrument, while the distal shaft portion electrically contacts the other of the power terminal and the ground terminal of the handheld instrument. When the proximal end of the conductive wire of the sterile medical device is received within the seat assembly and slidably disposed within the lumen of the conductive shaft of the sterile adapter, the proximal wire portion of the conductive wire of the sterile medical device electrically contacts the proximal shaft portion of the conductive shaft of the sterile adapter, and is thus electrically connected to one of the power terminal and the ground terminal of the handheld instrument via the proximal shaft portion of the conductive shaft, while the distal wire portion of the conductive wire of the sterile medical device electrically contacts the distal shaft portion of the conductive shaft of the sterile adapter, and is thus electrically connected to the other of the power terminal and the ground terminal of the handheld instrument via the distal shaft portion of the conductive shaft.

[0024] Alternatively, handheld instruments and medical devices can be essentially unipolar, in which case the grounding terminal of the handheld instrument is located away from the power terminal within the electrical port for electrical connection to a grounding electrode that can be positioned to contact a patient. In this case, when the proximal end of the conductive shaft is inserted into the electrical port of the handheld instrument, the conductive shaft of the sterile adapter can make electrical contact with the power terminal of the handheld instrument, and when the proximal end of the conductive wire is received within the seat assembly and slidably disposed within the lumen of the conductive shaft, the conductive wire of the sterile medical device can be electrically connected to the power terminal of the handheld instrument via the conductive shaft of the sterile adapter.

[0025] In one embodiment, the seat assembly of the sterile adapter may include a seat fixed to a sterile sleeve of the sterile adapter, such that a portion of the seat is located outside the sterile sleeve for receiving the proximal end of a conductive wire from a sterile medical device, while a portion of the seat is located inside the sterile sleeve for fixing to a conductive shaft housed within the sterile sleeve. The seat assembly may also include a rotary hemostatic valve (RHV) to which the conductive wire of the sterile medical device can be reversibly fixed relative to the seat. In this manner, movement of the proximal end of the conductive wire within the conductive shaft of the sterile adapter is prevented, thereby ensuring that the conductive wire remains in electrical contact with the conductive shaft.

[0026] The sterile adapter may optionally include a clamping mechanism configured to clamp the handheld instrument when housed within a sterile sleeve. This prevents movement between the proximal end of the conductive shaft of the sterile adapter and the electrical port of the handheld instrument, thereby ensuring that the conductive shaft remains in electrical contact with the power and / or ground terminals of the handheld instrument.

[0027] In the embodiments described herein, the sterile medical device is described as a vascular occlusion assembly having a vascular occlusion device capable of electrolytically separating from the conductive wires of the vascular occlusion assembly, and the handheld instrument is described as a handheld electrolytic separation device. However, it should be understood that the sterile medical device can be any medical device that can be introduced into a patient and has electrical functionality, and the handheld instrument can be any handheld instrument that transmits current to and / or receives current from the sterile medical device.

[0028] refer to Figures 1 to 2 An embodiment of a vascular occlusion treatment system 10 constructed according to the disclosed invention will now be described. The vascular occlusion treatment system 10 includes: a delivery catheter 12; a vascular occlusion component 14 slidably disposed within the delivery catheter 12; an electrolytic separation device 16 to which the vascular occlusion component 14 is removably fixed; and a sterile adapter 18 configured to physically isolate the electrolytic separation device 16 from the vascular occlusion component 14 while facilitating electrical connection between the electrolytic separation device 16 and the vascular occlusion component 14.

[0029] As will be discussed in further detail below, the vascular occlusion assembly 14 includes: a delivery line 20; and a vascular occlusion device 22, which is detachably connected to the delivery line 20 via an electrolytically disconnectable connector 24.

[0030] The delivery catheter 12 has a tubular configuration and may take the form of, for example, a microcatheter, a sheath, etc. The delivery catheter 12 includes: an elongated sheath body 26 having a proximal segment 28 and a distal segment 30; and an inner lumen 32 extending through the sheath body 26 between the proximal segment 28 and the distal segment 30 (shown in dashed lines), within which a vascular occlusion assembly 14 is housed. In an alternative embodiment, the delivery catheter 12 may include two inner lumens (not shown) extending through the sheath body 26 between the proximal segment 28 and the distal segment 30, and two vascular occlusion assemblies (not shown) may be housed in each of these two inner lumens, respectively. The free end of the proximal segment 28 of the sheath body 26 remains outside the patient and is accessible by an operator (e.g., a physician or doctor), while the remainder of the sheath body 26 (including the distal segment 30) is sized and designed to reach distal locations within the patient's vascular system. The sheath body 26 has an appropriate length for accessing a target tissue site within the patient from the vascular access point. The target tissue site depends on the medical procedure in which the delivery catheter 12 is used. For example, when the delivery catheter 12 is used to access the vascular system in the patient's brain from the femoral artery approach in the groin, the total length of the sheath body 26 can be from 125 cm to 200 cm. Additionally, the outer diameter of the sheath body 26 can be in the range of 3F to 10F. In one embodiment, the outer diameter of the sheath body 26 can be uniform along its length. In another embodiment, the outer diameter of the sheath body 26 can taper gradually or stepwise from a first outer diameter at the proximal segment 28 to a second outer diameter at the distal segment 30 to facilitate navigation in tortuous vascular systems. Although depicted as having a generally circular cross-sectional shape, it is understood that the sheath body 26 can include other cross-sectional shapes or combinations of shapes, such as oval, rectangular, triangular, polygonal, etc.

[0031] The delivery catheter 12 may include one or more regions along its length with different configurations and / or characteristics. For example, the outer diameter of the distal segment 30 of the sheath body 26 may be smaller than the outer diameter of the proximal segment 28 of the sheath body 26 to reduce the profile of the distal segment 30 and facilitate navigation in tortuous vascular systems. Furthermore, the distal segment 30 may be more flexible than the proximal segment 28. Typically, the proximal segment 28 may be formed of a more rigid material than the distal segment 30 of the sheath body 26, giving it sufficient pushability to advance through the patient's vascular system, while the distal segment 30 may be formed of a more flexible material, allowing it to remain flexible and more easily followed along the guideline to approach distal locations in tortuous regions of the vascular system. The sheath body 26 may be constructed of suitable polymeric materials, metals, and / or alloys, such as polyethylene, stainless steel, or other suitable biocompatible materials or combinations thereof. In some cases, the proximal segment 28 may include a reinforcing layer (such as a braided or wrapped layer) to enhance the pushability of the sheath body 26. The sheath body 26 may include a transition region located between the proximal segment 28 and the distal segment 30.

[0032] The delivery catheter 12 includes a distal port 34 communicating with the inner lumen 32 of the delivery catheter 12, from which the vascular occlusion device 22 is deployed. The delivery catheter 12 also includes a proximal adapter 36, which is secured to the proximal segment 28 of the sheath body 26 by suitable means (e.g., adhesive, welding, etc.). The proximal adapter 36 includes a central hole 38 (shown in dashed lines) communicating with the lumen 32 of the delivery catheter 12. The central hole 38 terminates at the proximal port 40 to allow loading of the vascular occlusion assembly 14 into the delivery catheter 12.

[0033] The delivery catheter 12 also includes one or more radiopaque marker bands 44 (in this case, two distal and proximal bands 44a, 44b) disposed on the distal segment 30 of the delivery catheter 12 near the distal port 34, which can be identified using medical imaging techniques (e.g., fluoroscopy). The distal band 44a can be used to position the distal end of the delivery catheter 12 within the patient's vascular system, while the proximal band 44b can be used to position the delivery catheter 12 relative to the partially or fully deployed vascular occlusion device 22, such that the delivery catheter 12 and the delivery line 20 can be longitudinally aligned to ensure that the electrolytically disconnectable connector 24 is located just distal to the distal port 34 of the delivery catheter 12 and in contact with bodily fluids in the patient's vascular system, facilitating electrolytic separation of the vascular occlusion device 22 from the delivery line 20, as will be discussed in further detail below. The radiopaque marker bands 44 can be made of suitable radiopaque materials, such as gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc.

[0034] Typically, the vascular occlusion device 22 has a delivery configuration when confined within the delivery catheter 12. Figure 1 ), and has a deployment configuration that conforms to the internal shape of the aneurysm sac (not shown) when deployed from the delivery catheter 12. Figure 2 The vascular occlusion device 22 can be pre-biased to form a cylindrical, conical, or other desired shape. The vascular occlusion device 22 can be flexible and its overall shape is easily deformable. In the illustrated embodiment, the vascular occlusion device 22 is shown as a helical coil formed from a wire having a suitable diameter (e.g., 1 mil to 6 mil). When in a delivery configuration, the diameter of the vascular occlusion device 22 can be, for example, 8 mil to 30 mil. The vascular occlusion device 22 can have any desired and suitable length for the site to be occluded, for example, 1 cm to 50 cm. In alternative embodiments, the vascular occlusion device 22 can take the form of a structure other than a coil, such as a braid. The vascular occlusion device 22 can optionally be covered or connected by a fibrous material bound to the outside of the coil or braid. The vascular occlusion device 22 can be made of a suitable biocompatible and radiopaque material, such as platinum, gold, tungsten, iridium, or alloys thereof, or other metals. In the illustrated embodiment, the vascular occlusion device 22 has an end cap or end that prevents the aneurysm sac from being punctured when it is delivered into the aneurysm sac.

[0035] The delivery line 20 can be a coil, wire, etc. (e.g., a conventional guide wire, a twistable cable tube, or a hypotube) that has sufficient columnar strength to allow the vascular occlusion device 22 to be pushed into the aneurysm sac. The delivery line 20 can have a suitable outer diameter (e.g., 10 mil to 30 mil) and a suitable length (e.g., 50 cm to 300 cm). The materials used to construct the delivery line 20 are chosen to impart different flexibility and stiffness properties to different sections of the delivery line 20. For example, the delivery line 20 can be formed of different materials along its length, such as materials with different elastic moduli, thus causing differences in flexibility.

[0036] In the illustrated embodiment, the delivery line 20 generally includes a conductive core wire 46 and a sheath 48 made of an electrically insulating material, such as polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, or other suitable polymeric material. The core wire 46 has: a proximal section 50 extending proximally from the proximal portion 30 of the delivery catheter 12 for physician manipulation; a distal section 52 to which the vascular occlusion device 22 is attached; and an intermediate section 54 disposed between the proximal section 50 and the distal section 52. The proximal section 50 of the core wire 46 tapers distally toward the medial section 54. The distal section 52 of the core wire 46 extends from the intermediate section 54 and tapers further distally to provide flexibility to the distal end of the delivery line 20. The delivery line 20 may include a coil (not shown) fixed around the distal section 52 of the core wire 46 to provide some columnar strength to the distal end of the delivery line 20 without adversely affecting the flexibility of the tapered distal section 52 of the core wire 46. A sleeve 48 is disposed on the distal segment 52 of the core wire 46 and, as discussed in further detail, serves to electrically isolate the portion of the distal segment 52 of the core wire 46 proximal to the electrolytically disconnectable connector 24 and the coil of the delivery line 20 from the blood in the patient's vascular system. The delivery line 20 also includes a radiopaque marking strip 56 disposed on the sleeve 48, which can be identified using medical imaging techniques (e.g., projection). The marking strip 56 can be used to position the delivery catheter 12 relative to the partially or fully deployed vascular occlusion device 22 (by aligning it relative to the proximal mark 44b of the delivery catheter 12), such that the delivery catheter 12 and the delivery line 20 can be longitudinally aligned to ensure that the electrolytically disconnectable connector 24 is located just distal to the distal port 34 of the delivery catheter 12 and in contact with the body fluids in the patient's vascular system, facilitating electrolytic dissociation of the vascular occlusion device 22 from the delivery line 20, as will be discussed in further detail below. The radiopaque marking band 56 can be made of a suitable radiopaque material, such as gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc.

[0037] Further reference Figure 3The vascular occlusion device 22 is secured to the distal portion 56 of the core wire 48 via an electrolytically resistant bushing 58. An electrolytically degradable connector 24, in the form of an electrolytically degradable section, is located on the core wire 46 between the electrically insulating bushing 48 and the vascular occlusion device 22 for electrolytically disconnecting the vascular occlusion device 22 from the delivery line 20, and this electrolytically degradable connector is situated on the core wire 46 between the electrically insulating bushing 48 and the vascular occlusion device 22. Therefore, when current is supplied to the core wire 46, current flows to the electrolytically degradable connector 24. However, the electrolytically degradable connector 24 is not electrically insulating and is therefore more readily electrolytically dissolved in blood than the portion of the core wire 46 covered by the electrically insulating bushing 48 and the vascular occlusion device 22. Thus, the electrolytically degradable connector 24 will dissolve substantially or completely, thereby allowing the release of the vascular occlusion device 22. Preferably, the length of the electrolytically degradable connector 24 is not much greater than the diameter of the electrolytically degradable connector 24. For example, the length of the electrolytic connector 24 can be as short as 0.00085 inches and typically does not exceed 0.15 inches.

[0038] Return to reference Figure 1 and Figure 2 Therefore, the delivery line 20 is inherently bipolar because it is capable of conducting current to and from the electrolytically disconnectable connector 24. For this purpose, the delivery line includes a proximal terminal 66a (in this case, a power terminal) and a distal terminal 66b (in this case, a return terminal) for delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 and for returning current from the electrolytically disconnectable connector 24 to the electrolytically disconnectable device 16, respectively. As will be described in further detail below, the delivery line 20 is specifically configured to provide an electrically isolated forward path to the electrolytically disconnectable connector 24 and an electrically isolated return path from the electrolytically disconnectable connector. In an alternative embodiment, the delivery line 20 may be inherently unipolar because it is only capable of delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24, and then returning that current to the distal grounding electrode in contact with the patient. In this case, the delivery line 20 may only include a power terminal (not shown) for delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24.

[0039] Further reference Figure 4The physician can operate the electrolytic separation device 16 to perform an electrolytic separation procedure. The electrolytic separation device 16 includes: a housing 62; an electrical port 64 (e.g., funnel-shaped) configured for electrical connection via a sterile adapter 18 (described in further detail below) to the delivery line 20 of the vascular occlusion assembly 14, and thus to an electrolytically disconnectable connector 24; electronic components (not shown) housed within the housing 62 for controlled current delivery to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14; a current delivery button 66, attached to the housing 62, for manually initiating current flow from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14; and a plurality of indicators 68 configured to report various events to the physician during the electrolytic separation procedure.

[0040] The housing 62 is constructed of a suitable material, such as acrylonitrile-butadiene-styrene (ABS) or polycarbonate, and its shape and size are designed for ergonomic grip by a physician using one hand. In the illustrated embodiment, the electrolytic separation device 16 is inherently bipolar, in which case the electrolytic separation device 16 includes both a power terminal 66a and a ground terminal 66b (in... Figure 7 As shown in the diagram, the power terminal and ground terminal are housed within electrical port 64 for connection to electronic components housed in housing 62. In an alternative embodiment, the electrolytic separation device 16 may include additional terminals (not shown) housed within electrical port 64, thereby enabling, for example, the electrolytic separation device 16 to identify the type of vascular occlusion assembly 22 electrically connected to it. In this way, the electrolytic separation device 16 can deliver current to the vascular occlusion assembly 22 according to electrical parameters corresponding to the type of vascular occlusion assembly 22 identified by the electrolytic separation device 16. In an alternative embodiment, the electrolytic separation device 16 is essentially unipolar, in which case the ground terminal would not be housed within electrical port 64 but would be located away from the electrical port (e.g., opposite to electrical port 64 in housing 62) for connection to a cable associated with a grounding electrode (not shown) positioned to contact the patient. The sterile adapter 18 may include an additional seat assembly (not shown) fixed to the sterile sleeve 70 to facilitate electrical connection between the individual ground terminal of the electrolytic separation device 16 and the cable connector associated with the grounding electrode.

[0041] Electronic components are configured to supply current to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 during one or more electrolytic separation cycles until the vascular occlusion device 22 is electrolytically separated from the delivery line 20, and to report various events occurring during the electrolytic separation procedure to the physician. In the illustrated embodiment, the current delivery button 66 is in the form of a push button that can be pressed to manually command the electrolytic separation device 16 to perform an electrolytic separation cycle (i.e., the time period during which current is supplied from the electronic components to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14). Alternatively, other types of manual control devices (e.g., switches, dials, etc.) can be used to manually command the electrolytic separation device 16 to perform an electrolytic separation cycle. Indicator 68 is configured to report various events to the physician during the electrolytic separation procedure, such as energization of the electrolytic separation device 16, active delivery of current from the electrolytic separation device 16 to the vascular occlusion assembly 22, assessment of successful electrolytic separation events, low battery indication, etc.

[0042] Further reference Figure 5 , Figure 6A and Figure 6B The sterile adapter 18 is designed to be disposable and therefore includes components that are less expensive compared to the electrolysis separation device 16. The sterile adapter 18 typically includes: a sterile sleeve 70, sized to removably accommodate the electrolysis separation device 16; a seat assembly 72, attached to the sterile sleeve 70 for receiving the proximal end of the core wire 46 of the vascular occlusion assembly 14; and a conductive shaft 74, attached to the seat assembly 72 and accommodated within the sterile sleeve 70.

[0043] In the illustrated embodiment, the handheld instrument is designed to be housed within a sterile sleeve 70, and in this case, the electrolytic separation device 16 determines the size and shape of the sterile sleeve 70. In the illustrated embodiment, the sterile sleeve 70 is constructed from two planar rectangular sheets 76a, 76b (in... Figure 6A and Figure 6B The aseptic sleeve 70 is in the form of a bag or pouch (best shown in the illustration), with two planar rectangular sheets joined together at three edges (in this case, the distal edge 78a and the opposing longitudinal edges 78b, 78c). The aseptic sleeve 70 is preferably closable, sealable, and openable. In the illustrated embodiment, the aseptic sleeve 70 has a sealable opening 80 located at the proximal edge 78d through which the electrolytic separation device 16 can be introduced into the interior of the aseptic sleeve 70. Although the aseptic sleeve 70 is shown as rectangular, it should be understood that the aseptic sleeve 70 can have any shape, including elliptical, hexagonal, egg-shaped, triangular, etc., or any other shape that can accommodate the insertion and removal of the electrolytic separation device 16.

[0044] In the illustrated embodiment, the opening 80 is reversibly sealed such that the electrolytic separation device 16 can be introduced into the interior of the sterile sleeve 70 through the opening 80 before sealing, and such opening 80 can subsequently be unsealed so that the electrolytic separation device 16 can be removed from the interior of the sterile sleeve 70 through the unsealed opening 80 without damaging the sterile sleeve 70. For example, the opening 80 can take the form of a zipper-type or sliding channel-type mechanism that can be pressed between the thumb and forefinger and slid along the proximal edge 78d of the sterile sleeve 70 in one direction, or otherwise pulled up, to seal the electrolytic separation device 16 within the sterile sleeve 70. The sealed opening 80 can then be reopened by pulling open or otherwise opening the sealed opening 80 at the proximal edge 78d using planar rectangular sheets 76a, 76b. In an alternative embodiment, opening 80 may be permanently sealed, for example using a plastic sealer, such that the electrolysis separation device 16 can be introduced into the interior of the sterile sleeve 70 through opening 80 before permanent sealing of opening 80, and then, after permanent sealing of opening 80, the electrolysis separation device 16 can be removed from the interior of the sterile sleeve 70 by tearing open the sterile sleeve 70 or otherwise cutting a hole in the sterile sleeve. The sterile sleeve 70 is made of a flexible polymer material, such as polyethylene or polypropylene. Preferably, the material constituting the sterile sleeve 70 is optically transparent, such that when the electrolysis separation device 16 is housed within the sterile sleeve 70, the current delivery button 66 and indicator 68 (in...) are visible. Figure 4 (As shown in the image) can be visualized.

[0045] The seat assembly 72 includes a seat 82 attached to the sterile sleeve 70, such that the proximal end of the core wire 46 of the vascular occlusion assembly 14 can be introduced from the outside of the sterile sleeve 70 into the conductive shaft 74 (described in further detail below) via the seat 82. The seat 82 includes a funnel-shaped port 84 through which the proximal end of the core wire 46 can enter the conductive shaft 74, as will be described in further detail below. In the illustrated embodiment, the seat 82 is configured to pass through the distal edge 78a of the sterile sleeve 70, such that the distal portion of the seat 82 resides outside the sterile sleeve 70, while the proximal portion of the seat 82 resides inside the sterile sleeve 70. During the manufacture of the sterile adapter 18, two planar rectangular sheets 76a, 76b of the sterile sleeve 70 can be joined together on the seat 82 at the distal edge 78a, such that when the opening 80 of the sterile sleeve 70 is sealed, the interior of the sterile sleeve 70 (the exterior of the conductive shaft 74) is sealed relative to the exterior of the sterile sleeve 70. Seat 82 may be made of a suitable rigid material, such as, for example, a rigid polymer (e.g., polystyrene, nylon, polycarbonate or methacrylate).

[0046] The conductive shaft 74 includes a lumen 88 in which the proximal end of the core wire 46 of the vascular occlusion assembly 14 can be slidably disposed when received by the seat 82. For this purpose, the distal end of the conductive shaft 74 is fixed to the seat 82 such that the lumen 88 of the conductive shaft 74 is coupled to a port 84 of the seat 82. For example, the seat 82 may include a proximal lumen 90 coupled to the port 84, and the distal end of the conductive shaft 74 is disposed within this proximal lumen and, for example, properly fixed within it by means of coupling.

[0047] The seat assembly 72 optionally includes a rotary hemostatic valve (RHV) 86, with which the seat 82 mates. The RHV 86 includes: a cylindrical tube 92 having a central lumen 94; a conventional convex Touhy-Borst connector 96 rotatably secured to the distal end of the cylindrical tube 92; and a Luer connector 98 secured to the proximal end of the cylindrical tube 92. The Luer connector 98 can mate with the seat 82 of the seat assembly 72. For example, the Luer connector 98 can be in the form of a complementary Luer connector that mates with the Luer connector 98. The proximal end of the core wire 46 of the vascular occlusion assembly 14 can then be inserted through the central lumen 94 of the RHV 86, through the port 84 of the seat 82, and into the lumen 88 of the conductive shaft 74. The RHV 86 may also include one or more seals (not shown) disposed within the central lumen 94 for sealing fluid flow between the outer surface of the core wire 46 and the inner surface of the cylindrical tube 92. The RHV86 is configured to reversibly secure the core wire 46 relative to the seat 82. To this end, the RHV 86 also includes a clamping nut 100 configured to press one of a plurality of seals against the outer surface of the core wire 46 to secure it when the Touhy-Borst connector 96 rotates in one direction, and to release the seal from the outer surface of the core wire 46 to release it when the Touhy-Borst connector 96 rotates in the opposite direction.

[0048] The proximal end of the conductive shaft 74 is configured for tight insertion into the electrical port 64 of the electrolytic separation device 16. In the illustrated embodiment, the sterile adapter 18 is essentially bipolar because it enables current to be delivered from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 and back from the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 to the electrolytic separation device 16. For this purpose, the sterile adapter 18 includes a proximal terminal 106a (in this case, a power terminal) and a distal terminal 106b (in this case, a distal terminal) for delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 and for returning current from the electrolytically disconnectable connector 24 to the electrolytic separation device 16, respectively. As will be described in further detail below, the conductive shaft 74 is specifically configured to provide an electrically isolated forward path to the electrolytically disconnectable connector 24 and an electrically isolated return path from the electrolytically disconnectable connector. In an alternative embodiment, the sterile adapter 18 may be essentially unipolar, as it is only capable of delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24, and then returning that current to the distal grounding electrode in contact with the patient. In this case, the delivery line 20 may consist only of a power terminal (not shown) for delivering current from the electrolytic separation device 16 to the electrolytically disconnectable connector 24.

[0049] It is worth noting that when the proximal end of the core wire 46 of the vascular occlusion assembly 14 is fully inserted into the lumen 88 of the conductive shaft 74 via the port 84 of the seat 82 of the sterile adapter 18, the power supply terminals and ground terminals 66a and 66b of the vascular occlusion assembly 14 (in) Figures 1 to 2 (As shown in the diagram) the power terminals and ground terminals 106a and 106b of the sterile adapter 18 are respectively electrically contacted, and when the proximal end of the conductive shaft 74 is fully inserted into the electrical port 64 of the electrolytic separation device 16 (in Figure 5 As shown in the figure, the power supply and grounding terminals 106a and 106b of the sterile adapter 18 make electrical contact with the power supply and grounding terminals 66a and 66b of the electrolysis separation device 16, respectively.

[0050] Therefore, when the electrolytic separation device 16 is housed and sealed within the sterile sleeve 70 of the sterile adapter 18, the power supply terminals and grounding terminals 66a and 66b of the vascular occlusion assembly 14 are electrically connected to the power supply terminals and grounding terminals 66a and 66b of the electrolytic separation device 16 via the power supply terminals and grounding terminals 106a and 106b of the sterile adapter 18, respectively. This allows current to be supplied from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 in response to manual actuation of the current supply button 66 of the electrolytic separation device 16, and current can also be returned from the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 to the electrolytic separation device 16, while simultaneously physically isolating the electrolytic separation device 16 from the vascular occlusion assembly 14. The proximal end of the conductive shaft 74 is sealed so that when the electrical port 64 of the electrolytic separation device 16 is contained and sealed within the sterile sleeve 70, contaminants cannot enter the electrical port 64 of the electrolytic separation device 16 through the port 84 of the seat 82 or through the lumen 88 of the conductive shaft 74.

[0051] Of course, if the vascular occlusion assembly 14, the sterile adapter 18, and the electrolytic separation device 16 are essentially unipolar, then when the electrolytic separation device 16 is housed and sealed within the sterile sleeve 70 of the sterile adapter 18, only the power terminal of the vascular occlusion assembly 14 will be electrically connected to the power terminal of the electrolytic separation device 16 via the power terminal of the sterile adapter 18. This would allow current to be delivered from the electrolytic separation device 16 to the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 in response to manual actuation of the current delivery button 66 of the electrolytic separation device 16, and current can also be returned from the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14 to a separate grounded electrode placed away from the electrolytic separation device 16 and in contact with the patient, while physically isolating the electrolytic separation device 16 from the vascular occlusion assembly 14.

[0052] It should be noted that the spacing and size of the power supply terminals and grounding terminals 66a, 66b of the vascular occlusion assembly 14, as well as the corresponding spacing and size of the power supply terminals and grounding terminals 106a, 106b of the sterile adapter 18, can be selected so that one or more status terminals 66c, 66d in the electrical ports 64 of the electrolytic separation device 16 (in Figure 7 (As shown in the figure) The power supply terminal and grounding terminal 106b, 106a of the sterile adapter 18 can be electrically contacted in a unique manner to determine the type of vascular occlusion assembly 14 currently used with the electrolytic separation device 16, as will be described in further detail below.

[0053] Now for reference Figure 7 This section describes a specific implementation of the core wire 46 of the vascular occlusion assembly 14 and the conductive shaft 74 of the sterile adapter 18. In this implementation, the vascular occlusion assembly 14 and the sterile adapter 18 are essentially bipolar.

[0054] The core wire 46 of the vascular occlusion assembly 14 includes: a proximal conductive shaft portion (in this case, a thiopancreatic tube) 108a; a distal conductive shaft portion (in this case, a thiopancreatic tube) 108b, partially overlapping the proximal thiopancreatic tube 108a to form an overlap region 110; and an electrically insulating element (in this case, a layer) 112, disposed between the proximal and distal thiopancreatic tubes 108a, 108b and spanning the overlap region 110 of the proximal and distal thiopancreatic tubes. The proximal and distal thiopancreatic tubes 108a, 108b can be made of a suitable conductive material, such as, for example, stainless steel, while the electrically insulating layer 112 can be made of a suitable electrically insulating material, such as, for example, polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, or other suitable polymer materials. It should be noted that the exposed portion of the proximal thiopancreatic tube 108a corresponds to the power terminal 66a (in... Figures 1 to 2 (as shown in the image), while the exposed portion of the distal submersible 108b corresponds to the grounding terminal 66b (in... Figures 1 to 2 (As shown in the figure). The core wire 46 also includes: a conductive epoxy dome 114 formed on the free end of the near-end of the submersible tube 108a; and an insulating conductor 116 fixed between the conductive epoxy dome 114 and the electrolytically disconnectable connector 24.

[0055] Similarly, the conductive shaft 74 of the sterile adapter 18 includes: a proximal conductive shaft portion (in this case, a thiopanle) 118a; a distal conductive shaft portion (in this case, a thiopanle) 118b, partially overlapping the proximal thiopanle 118a to form an overlap region 120; and an electrically insulating element (in this case, a layer) 122, disposed between the proximal thiopanle 118a and the distal thiopanle 118b and spanning the overlap region 120 of the proximal and distal thiopanles. The proximal and distal thiopanles 118a, 118b can be made of a suitable conductive material, such as, for example, stainless steel, while the electrically insulating layer 122 can be made of a suitable electrically insulating material, such as, for example, polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, or other suitable polymer materials. It should be noted that the exposed portion of the proximal thiopanle 118a corresponds to the power terminal 106a (in... Figure 5 (as shown in the diagram), while the exposed portion of the distal submersible 118b corresponds to the grounding terminal 106b (in... Figure 5 (As shown in the figure). The conductive shaft 74 also includes a conductive epoxy dome 124 formed on the free end of the near-end of the submersible tube 118a, thereby sealing the lumen 88 of the conductive shaft 74, as discussed above.

[0056] When the proximal end of the core wire 46 of the vascular occlusion assembly 14 is fully inserted into the lumen 88 of the conductive shaft 74 of the sterile adapter 18, as Figure 7As shown, conductive epoxy resin domes 114 and 124 are in electrical contact with each other, near-end thiopanles (power terminals 66a and 106a) 108a and 118a are in electrical contact with each other, and far-end thiopanles 108b and 118b (ground terminals 66b and 106b) are in electrical contact with each other. Furthermore, when the near-end of the conductive shaft 74 of the sterile adapter 18 is fully inserted into the electrical port 64 of the electrolytic separation device 16, as... Figure 7 As shown, the near-end and far-end thiopant tubes 108a and 108b (power supply terminals and grounding terminals 106a and 106b) of the conductive shaft 74 are in electrical contact with the power supply terminals and grounding terminals 66a and 66b of the electrolytic separation device 16, respectively.

[0057] Therefore, an advancing electrical path 126a is formed from the power terminal 66a of the electrolytic separation device 16, through the proximal thiopanle 118a / conductive epoxy dome 124 of the conductive shaft 74 of the sterile adapter 18, through the proximal thiopanle 108a / conductive dome 114 of the vascular occlusion assembly 14, and along the insulating conductor 116 to the electrolytically disconnectable connector 24. At the same time, a returning electrical path 126b is formed from the electrolytically disconnectable connector 24 of the vascular occlusion assembly 14, along the distal thiopanle 108b, through the distal thiopanle 118b of the sterile adapter 18, and to the ground terminal 66b of the electrolytic separation device 16.

[0058] It should be noted that the proximal tube 118a of the sterile adapter is in electrical contact with one or more of the status terminals 66c, 66d of the electrolytic separation device 16. The type of the vascular occlusion assembly 14 used with the electrolytic separation device 16 can be encoded into the length of the proximal tube 118a of the conductive shaft 74 of the sterile adapter 18, so that the electrolytic separation device 16 can identify the type of vascular occlusion assembly 14 to which it is connected. For example, in the illustrated embodiment, the length of the proximal tube 118a has been selected such that it spans and is in electrical contact with all three terminals 66a and 66c-66d, thereby short-circuiting the three terminals 66a-66c together and indicating to the electrolytic separation device 16 that the vascular occlusion assembly 14 is of the first type. The length of the proximal tube 118a can be shortened so that it spans the power terminal 66a and the status terminal 66b and makes electrical contact with these terminals, thereby short-circuiting only these two terminals 66a-66b (while the status terminal 66c remains open) and indicating to the electrolytic separation device 16 that the vascular occlusion assembly 14 is of the second type.

[0059] In an alternative embodiment where the vascular occlusion assembly 14 and the sterile adapter 18 are essentially unipolar, the core wire 46 of the vascular occlusion assembly 14 simply comprises a single shaft (or thiopanthus tube) electrically connected to an electrolytically disconnectable connector 24, to which a conductive epoxy dome 114 is fixed, while the conductive shaft 74 of the sterile adapter 18 comprises a single conductive shaft to which a conductive epoxy dome 124 is fixed, as... Figure 8 As shown. In this configuration, when the proximal end of the core wire 46 of the vascular occlusion assembly 14 is fully inserted into the lumen 88 of the conductive shaft 74 of the sterile adapter 18, the conductive epoxy domes 114 and 124 are in electrical contact with each other, and the core wire 46 and the conductive shaft 74 are in electrical contact with each other. Furthermore, when the proximal end of the conductive shaft 74 of the sterile adapter 18 is fully inserted into the electrical port 64 of the electrolytic separation device 16, the conductive shaft 74 is in electrical contact with the power terminal 66a of the electrolytic separation device 16. Thus, a forward electrical path 126a is formed from the power terminal 66a of the electrolytic separation device 16, through the conductive epoxy domes and conductive shaft 74 of the sterile adapter 18, through the conductive dome 114 of the vascular occlusion assembly 14, and along the core wire 48 to the electrolytically disconnectable connector 24. The sterile adapter 18 may include an additional socket assembly (not shown) for insertion into a separate grounding port (not shown) of the electrolytic separation device 16. This additional mounting assembly may include a cable assembly (not shown) having: a plug residing within a sterile sleeve 70 for connection to a separate grounding port of the electrolytic separation device 16; a cable extending from the plug through the sterile sleeve 70; and another plug for connection to a grounding electrode.

[0060] exist Figure 9 and Figure 10 In the optional embodiment shown, the sterile adapter 18' further includes a clamping mechanism 130 ( Figure 9 The clamping mechanism 130' shown Figure 10 The clamping mechanism 130" shown is configured to clamp the electrolytic separator 16 when it is housed within the sterile sleeve 70 of the sterile adapter 18. Each of these clamping mechanisms 130', 130" includes a block 132 fixed to the distal edge 78a of the sterile sleeve. Each of the clamping mechanisms 130', 130" includes a clamping arm located inside the sterile sleeve 70 and whose base is fixed to the block 132.

[0061] Specifically, Figure 9The clamping mechanism 130' shown includes a pair of elastic arms 134, each having an outwardly curved region 136 spaced apart from each other in such a way that the outwardly curved regions 136 of the respective elastic arms 134 clamp the opposing curved edges 138 of the housing 62 of the electrolytic separator 16. Thus, when the electrolytic separator 16 is inserted through the opening 80 into the interior of the sterile sleeve 70, the conductive shaft 74 of the sterile adapter 18 can be inserted into the electrical port 64 of the electrolytic separator 16, while the opposing curved edges 138 of the housing 62 of the electrolytic separator 16 push the pair of elastic arms 134 away from each other until the outwardly curved regions 136 of the respective elastic arms 134 coincide with and laterally clamp the opposing curved edges 138 of the housing 62 of the electrolytic separator 16.

[0062] On the contrary, Figure 10 The clamping mechanism 130 shown includes a pair of arms 140, each of which includes a pair of resilient fingers 142 spaced apart from each other in such a way that the multiple pairs of resilient fingers 142 clamp the opposing top and bottom surfaces 144 of the housing 62 of the electrolytic separator 16. Thus, when the electrolytic separator 16 is inserted through the opening 80 and into the interior of the sterile sleeve 70, the conductive shaft 74 of the sterile adapter 18 can be inserted into the electrical port 64 of the electrolytic separator 16, while the opposing curved edges 138 of the housing 62 of the electrolytic separator 16 push the multiple pairs of resilient fingers 142 away from each other, and the multiple pairs of resilient fingers laterally clamp the opposing top and bottom surfaces 144 of the housing 62 of the electrolytic separator 16.

[0063] In this way, movement between the proximal end of the conductive shaft 74 of the sterile adapter 18 and the electrical port 64 of the electrolytic separator 16 can be prevented, thereby ensuring that the conductive shaft 74 remains in electrical contact with the power supply terminal 66a and / or grounding terminal 66b of the electrolytic separator 16.

[0064] Although specific embodiments have been shown and described herein, those skilled in the art will understand that these specific embodiments are not intended to limit the disclosed invention, and it will be apparent to those skilled in the art that various changes, modifications, and alterations (e.g., sizes of various parts, combinations of parts) can be made without departing from the scope of the disclosed invention, the scope of which is defined only by the appended claims and their equivalents. Therefore, the specification and drawings are to be regarded as illustrative rather than restrictive. The various embodiments shown and described herein are intended to cover alternatives, variations, and equivalents of the disclosed invention, which may be included within the scope of the appended claims.

Claims

1. A sterile adapter for electrically connecting a conductive wire of a medical device to an electrical port of a handheld instrument, the sterile adapter comprising: A sterile sleeve, the size of which is designed to removably accommodate the handheld instrument; A seat assembly is attached to the sterile sleeve for receiving the proximal end of the conductive wire of the medical device; as well as A conductive shaft, fixed to the base assembly and housed within the sterile sleeve, the conductive shaft having a distal end fixed to the base 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 base assembly.

2. The sterile adapter according to claim 1, wherein, The sterile sleeve is optically transparent.

3. The sterile adapter according to claim 1, wherein, The sterile sleeve has a sealable opening into which the handheld instrument can be inserted and removed.

4. The sterile adapter of claim 1 further includes a clamping mechanism fixed to the sterile sleeve, the clamping mechanism being configured to clamp the handheld instrument when it is housed in the sterile sleeve.

5. The sterile adapter according to claim 1, wherein, The seat assembly includes: a seat fixed to the sterile sleeve; and a rotary hemostatic valve (RHV) fixed to the seat, the rotary hemostatic valve being used to reversibly secure the conductive wire of the medical device relative to the seat.

6. The sterile adapter according to claim 1, wherein, The conductive shaft is a sodium hypochlorite tube.

7. The sterile adapter according to claim 1, wherein, The lumen of the conductive shaft is closed at the proximal end of the conductive shaft.

8. The sterile adapter according to claim 7, wherein, The near end of the conductive shaft has a conductive epoxy resin cap.

9. The sterile adapter according to claim 1, wherein, The 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. The sterile adapter according to claim 9, wherein, The proximal axial portion is a proximal sub-thiocyanate tube, and the second axial portion is a distal sub-thiocyanate tube, wherein one of the proximal sub-thiocyanate tube and the distal sub-thiocyanate tube is partially inserted into the other of the proximal sub-thiocyanate tube and the distal sub-thiocyanate tube to form an overlapping region, and wherein the electrical insulating element is an electrical insulating layer disposed between the proximal sub-thiocyanate tube and the distal sub-thiocyanate tube and spanning the overlapping region of the proximal sub-thiocyanate tube and the distal sub-thiocyanate tube.

11. A medical kit comprising: Medical devices, including conductive wires; A handheld instrument, including an electrical port having at least one electrical terminal; as well as A sterile adapter includes: a sterile sleeve, the size of which is designed to removably accommodate the handheld instrument; A base assembly, attached to the sterile sleeve, for receiving the proximal end of the conductive wire of the medical device; and a conductive shaft, fixed to the base assembly and housed within the sterile sleeve, the conductive shaft having a distal end fixed to the base assembly and a proximal end configured to be inserted into the electrical port of the handheld instrument, such that at least one electrical terminal of the handheld instrument is in electrical contact with 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 base assembly, such that the conductive wire is electrically connected to at least one electrical terminal of the handheld instrument via the conductive shaft of the sterile adapter.

12. The medical kit of claim 11, wherein, The medical device is a vascular occlusion assembly, which includes a vascular occlusion device electrolytically attached to the distal end of the conductive wire, and wherein the handheld instrument is a handheld electrolytic separation device.

13. The medical kit of claim 11, wherein, The handheld instrument includes at least one control device for supplying current to the medical device via the at least one electrical terminal, and wherein the sterile sheath is optically transparent.

14. The medical kit of claim 11, wherein, The sterile sleeve has a sealable opening into which the handheld instrument can be inserted and removed.

15. The medical kit of claim 11, wherein, The sterile adapter also includes a clamping mechanism fixed to the sterile sleeve, the clamping mechanism being configured to clamp the handheld instrument when it is contained within the sterile sleeve.

16. The medical kit of claim 11, wherein, The seat assembly includes: a seat fixed to the sterile sleeve; and a rotary hemostatic valve (RHV) fixed to the seat, the rotary hemostatic valve being used to reversibly secure the conductive wire of the medical device relative to the seat.

17. The medical kit of claim 11, wherein, The conductive shaft is a sodium hypochlorite tube.

18. The medical kit of claim 11, wherein, The lumen of the conductive shaft is closed at the proximal end of the conductive shaft.

19. The medical kit of claim 18, wherein, The near end of the conductive shaft has a conductive epoxy resin cap.

20. The medical kit of claim 11, wherein, The at least one electrical terminal of the handheld instrument includes a power terminal disposed in the electrical port, wherein the medical device includes a power terminal disposed on the conductive wire, and wherein the sterile adapter includes a power terminal disposed on the conductive shaft, such that when the 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 the 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.

21. The medical kit of claim 20, wherein, The at least one electrical terminal of the handheld instrument further includes a grounding terminal, wherein the medical device further includes a grounding terminal disposed on the conductive wire, and wherein the sterile adapter further includes a grounding terminal disposed on the conductive shaft, such that when the proximal end of the conductive wire is inserted into the lumen of the conductive shaft of the sterile adapter, the grounding terminal of the medical device electrically contacts the grounding terminal of the sterile adapter, and such that when the proximal end of the conductive shaft of the sterile adapter is inserted into the electrical port of the handheld instrument, the grounding terminal of the handheld instrument electrically contacts the grounding terminal of the sterile adapter.

22. The medical kit according to claim 21, in, The conductive wire of the vascular occlusion assembly includes a first proximal shaft portion, a first distal shaft portion, and a first electrical insulating element disposed between the first proximal shaft portion and the first distal shaft portion, thereby forming a power supply terminal and a ground terminal of the vascular occlusion assembly. and The conductive shaft of the sterile adapter includes a second proximal shaft portion, a second distal shaft portion, and a second electrically insulating element disposed between the second proximal shaft portion and the second distal shaft portion, thereby forming the power supply terminal and grounding terminal of the sterile adapter.

23. The medical kit according to claim 22, in, The first proximal shaft portion is a first proximal sodium thiosulfate tube, and the first distal shaft portion is a first distal sodium thiosulfate tube, wherein one of the first proximal sodium thiosulfate tube and the first distal sodium thiosulfate tube is partially inserted into the other of the first proximal sodium thiosulfate tube and the first distal sodium thiosulfate tube to form an overlapping region, and wherein the first electrical insulating element is a first electrical insulating layer disposed between the first proximal sodium thiosulfate tube and the first distal sodium thiosulfate tube and spanning the overlapping region of the first proximal sodium thiosulfate tube and the first distal sodium thiosulfate tube; and Wherein, the second proximal shaft portion is a second proximal subcapsule tube, the second distal shaft portion is a second distal subcapsule tube, wherein one of the second proximal subcapsule tube and the second distal subcapsule tube is partially inserted into the other of the second proximal subcapsule tube and the second distal subcapsule tube to form an overlapping region, and wherein the second electrical insulating element is a second electrical insulating layer disposed between the second proximal subcapsule tube and the second distal subcapsule tube and spanning the overlapping region of the second proximal subcapsule tube and the second distal subcapsule tube.

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