Apparatus and Device for the Electrical Interconnect of Implantable Devices

20210187308 · 2021-06-24

    Inventors

    Cpc classification

    International classification

    Abstract

    A device and means of electrical interconnection and electrical circuit isolation between an implantable stimulation, receiving and/or data transmission lead and a pulse generating or monitoring device. Pulse generating and monitoring devices require an electrical and mechanical interconnection between the stimulation, recording and/or data transmission wires and the active electronic system, each channel or circuit electrically isolated with a high impendence barrier. This device will allow for a rectangular, high-density, unibody, secured, low insertion force connector configuration, increasing the number of connectors and reducing implant size while increasing the number of stimulation and recording channels.

    Claims

    1. An electrical contact connector for electrically coupling a contact ring of a stimulation, recording and/or data transmission lead to an active implantable medical device, said contact comprising: a rectangular framed, uni-body housing having a hollow center for the reception of said lead; said hollow center exhibiting a center axis running coaxially with the centrally deposed axis of said lead; said rectangular framed, uni-body housing exhibiting integrated upper and lower depressions for the internal positioning and securing of a pair of parallel coil springs; said rectangular framed, uni-body housing exhibiting internal side recesses for the acceptance of radial expansion of said coil springs upon lead insertion; said framed coil springs made to at least partially extend into said hollow center and made to accept said lead contact ring; and said each housing coil springs made to accept exactly one lead contact ring.

    2. The electrical contact connector of claim 1, wherein said rectangular framed housing may be metallic, semi-metallic or non-metallic.

    3. The electrical contact connector of claim 2, wherein said uni-body framed housing contact connector is metallic or semi-metallic and is constructed using additive manufacturing.

    4. The electrical contact connector of claim 1, wherein said parallel coil springs are made to flex radially outward into said internal side recesses upon insertion of said lead.

    5. The electrical contact connector of claim 1, wherein exhibited depressions may have centrally deposed posts for the positioning and securing of a pair of parallel coil springs.

    6. The said coil springs of claim 1, wherein each coil spring may have varying diameters and varying pitches per individual coil spring.

    7. The depressions of claim 1, wherein said depressions may be cylindrical, square, octagonal or any shape made to accommodate said coil spring.

    8. An electrical contact connector for electrically coupling a contact ring of a stimulation, recording and/or data transmission lead to an active implantable medical device, said contact comprising: a rectangular framed, uni-body housing having a hollow center for the reception of said lead; said hollow center exhibiting a center axis running coaxially with the centrally deposed axis of said lead; said rectangular framed, uni-body housing exhibiting integrated upper and lower posts for the internal positioning and securing of a pair of parallel coil springs; said rectangular framed, uni-body housing exhibiting internal side recesses for the acceptance of radial expansion of said coil springs upon lead insertion; said framed coil springs made to at least partially extend into said hollow center and made to accept said lead contact ring; and said each housing coil springs made to accept exactly one lead contact ring.

    9. The electrical contact connector of claim 10, wherein said uni-body framed housing contact connector is metallic or semi-metallic and is constructed using additive manufacturing.

    10. The said coil springs of claim 10, wherein each coil spring may have varying diameters and varying pitches per individual coil spring.

    11. The depressions of claim 10, wherein said depressions may be cylindrical, square,

    12. A method of securing a contact connector ring of a stimulation, recording and/or data transmission lead to a contact connector of an active implantable medical device comprising the steps of: constructing a uni-body, rectangular framed housing contact connector exhibiting a hollow center; inserting within said framed housing parallel, coil springs running coplanar within said frame; said parallel coil springs residing at least partially within said hollow center; coupling a feedthrough wire from said implantable device to said contact connector; inserting into a medical stimulation or recording device a plurality of contact connectors in series and perpendicular to an insertable stimulation or recording implantable lead's axis; inserting into said medical device a stimulation or recording lead exhibiting contact rings proximal to said implantable medical device and implantable electrodes or another medical device distal to said implantable medical device; securing said insertable stimulation or recording implantable lead through each contact connector wherein exactly one contact ring is made to connect to one contact connector; and said stimulation or recording implantable lead, after reaching a terminal point within the implantable device is secured by set screws.

    13. The method of claim 8, wherein said uni-body framed housing contact connector is metallic or semi-metallic and is constructed using additive manufacturing.

    14. The method of claim 8, wherein parallel coil springs may be inserted and secured within said frame via depressions manufactured within the frame, posts within the frame or a combination thereof.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0026] Novel features characteristics of the application are set forth in the appended claims. However, the application itself, as well as a preferred mode of use, and further objectives and advantages thereof, will best be understood by referencing the following detailed description when read in conjunction with the accompanying drawings, wherein:

    [0027] FIG. 1. shows an isometric view of the front side of a 32-channel implantable medical device and leads.

    [0028] FIG. 2. illustrates an isometric view of the back side of a 32-channel implantable medical device and leads.

    [0029] FIG. 3 displays an isometric exploded view of the back side of a 32-channel implantable medical device and leads of FIG. 2.

    [0030] FIG. 4a shows an top view of the of a 32-channel implantable medical device and leads wherein the top half of the connector assembly has been sectioned to show the internal components and certain sections have been enlarged to show detail.

    [0031] FIG. 4b exhibits a lead axis and perpendicular orientation of lead connectors in series.

    [0032] FIG. 5a is an isometric view of the “thick” rectangular dual spring side loading connector assembly utilizing securing depressions and/or posts.

    [0033] FIG. 5b depicts an isometric view of the “thin” rectangular dual spring side loading connector assembly utilizing securing posts.

    [0034] FIG. 6a shows the orthographic view of a “thick” rectangular dual spring side loading connector assembly with inserted coil spring.

    [0035] FIG. 6b shows the orthographic view of a “thin” rectangular dual spring side loading connector assembly with inserted coil spring.

    [0036] FIG. 7. shows the orthographic and isometric views of the dual spring side loading housing without an inserted coil spring.

    [0037] FIG. 8 (9) shows the isometric views of the 16 channel neurostimulation lead and the dual side loading connector assembly, before engagement, spring coils largely parallel, and after engagement, spring coils deformed radially outward.

    [0038] FIG. 10 exhibits coil springs of varying diameters as to better accommodate lead insertion.

    [0039] And while the device, system and method of use of the present application is susceptible to various modifications and alternative forms, specific embodiments included herewith have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description, describing specific embodiments, is not intended to limit the application to the particular embodiment disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present application as defined by the appended claims read in context of the disclosure.

    DETAILED DESCRIPTION AND BEST MODE OF IMPLEMENTATION

    [0040] Illustrative embodiments of preferred embodiment are described below and depicted in the figures. It must be appreciated that in the development of any preferred embodiments, numerous references are made to the spatial relationships between various components and to the spatial orientation of various aspects of components as the devices depicted in the appended drawings. However, as will be recognized by those skilled in the art after a complete reading of the present application, the devices, members, and apparatuses described herein may be positioned in any desired orientation which addresses the above deficiencies of the prior art. Thus, the use of terms to describe a spatial relationship between various components or to describe the spatial orientation of aspects of such components (e.g. lead connectors, lead electrodes, impulse generating devices, coil springs and the like) should be understood to describe a relative relationship between the components or a spatial orientation of aspects of such components, respectively, whereas the device described herein may be oriented as to provide an ergonomic, rectangular and compact uni-body lead connector construct that is designed explicitly for low-force lead insertion, high-density and compacted arrangements providing for increased connector capacity, enhanced modulation and connector expansion leading to a smaller impulse generator device footprint.

    [0041] The present invention will be understood by those having skill in the art, both as to its structure and operation, taken in conjunction with the accompanying description and drawings. It should be understood that various components, parts, and features of the different embodiments may be combined together and/or interchanged with one another, all of which are within the scope of the present application, even though not all variations and particular embodiments are shown in the drawings. It should also be understood that the mixing and matching of features, elements, and/or functions between various embodiments is expressly contemplated herein so that one of ordinary skill in the art would appreciate from this disclosure that the features, elements, and/or functions of one embodiment may be incorporated into another embodiment as appropriate.

    [0042] Referring to FIG. 1, FIG. 1 illustrates a medical implant device 10 consisting of an electrical interconnect system 12, consisting of internalized implantable pulse generator electronics 15 and two 16-channel stimulation/recording leads 20 (evidenced as 20a and 20b). FIG. 1 exhibits upper and lower stimulation/recording leads 20a and 20b which are held securedly within electrical interconnect system 12 through insertion of set screws 60 through upper and lower apertures 62a and 62b of externally residing set screw guide 62.

    [0043] FIG. 2 provides for a reverse view of FIG. 1 wherein upper stimulation/recording lead 20a and lower stimulation/recording lead 20b are seen to pass through set screw block 70a and 70b, respectively, and into electrical interconnect system 12.

    [0044] FIG. 3, shows an exploded view of FIG. 2, displays two 16-channel stimulation/recording leads 20a and 20b, a truncated set of stimulation electrodes 25a and 25b, set screw bands 30a and 30b, interconnect bands 40a and 40b, which are inserted into electrical interconnect system 12, connector housing 50, secured by set screws 60a and 60b and set screw blocks 70a and 70b, through each side load spring contact assembly 100, which corresponds to exactly one feedthrough wire 120 and into the internalized portion implantable pulse generator electronics 15. And while each side load spring contact assembly 100 may be seen removed from the connector housing 50 in FIG. 3 in the exploded view, it is to be understood that each side load spring contact assembly 100 is placed and secured into designated receiving slots, above and below, wherein contact connector rings 25a and 25b reside on lead 20a and 20b. It may be noted that the distal end of recording and stimulation lead 20a, 20b may as well be another medical stimulation or recording device.

    [0045] FIG. 4a illustrates a top view neurostimulation system 10 and FIG. 4b a side view showing medical implant device 10 and a 32-channel neurostimulation system with two 16-channel stimulation/recording leads 20 inserted and held in place by the tightening of the sets screw 60 and set screw block 70 against a set screw band.

    [0046] Referring to FIG. 4a, FIG. 4a displays a (a) top view, and two exploded views: (b) top left set screw sectional view and (c) bottom right connector/lead sectional view showing a neurostimulation system 10 encompassing two 16-channel stimulation/recording leads, 20a visible and 20b beneath 20a, whose insertion causes each side load spring contact 140 to deform in an outward manner as a mechanical and electrical connection is created between an interconnect band 40a, corresponding to the 16-channel stimulation/recording lead 20a, and interconnect band 40b, corresponding to the 16-channel stimulation/recording lead 20b, whereby the implantable pulse generator electronic system 15 supplies and receives impulses via attached feedthrough wires 120 (see FIG. 3) into receiving slots 55. Receiving slots 55 evidencing an upper and lower set of connectors 100 (see FIG. 4b below) and insulator seals 131 placed between spring contacts 100.

    [0047] Referring to FIG. 4b, FIG. 4b depicts a side detailed view showing 2 leads 20a, 20b of a 32-channel neurostimulation system 10 with two 16-channel stimulation/recording leads 20 inserted through screw set 70a and 70b, respectfully and through individual hollow cores 170 of connectors 100 along axis 220. FIG. 4b additionally shows insulator seal 131 placed between spring contacts 100 (See as well FIG. 3) of receiving slots 55 in a largely connector 100-seal 131-connector 100-seal 131 configuration. Insulator seal 131 creates a high impendence electrical path between spring contacts 140 and set screw block 70 (also shown in top left of FIG. 4a). The insulator seal 131 is an integral part of the connector housing's interior 80 or may be a separate component assembled into connector housing 12. The width of seal 131 can range from 0.050 inch (1.27 mm) to 0.005 inch (0.127 mm). The spacing between spring contact 140 to spring contact 140 can range from 0.050 inch (1.27 mm) to 0.005 inch (0.127 mm). The spacing between spring contact 140 to set screw back 70 can range from 0.050 inch (1.27 mm) to 0.005 inch (0.127 mm). Seal 131 is a compliant or flexible material such as silicone rubber, urethane or a combination of other flexible materials.

    [0048] Referring now to FIGS. 5a, 5b, 6a and 6b, two possible versions of the side load spring contact assembly 110 is exhibited where the side load spring contact 140 captured by the housing frame 130a is held and secured by depressions 132 and 133 (which may also harbor securing posts 132 and 133) and 130b shows coil spring 140 held and secured by posts 139 and 139. The center axis 180a through the hollow core 170 of housing frame 130a in FIG. 5a represents the ultimate receptacle of the cylindrical axis 220 (see FIG. 4), running coaxially, of the 16-channel stimulation/recording lead 20. The center axis 180b through the hollow core 170 of housing frame 130b in FIG. 5b represents the ultimate receptacle of the cylindrical axis 220 (see FIG. 4), running coaxially, of the 16-channel stimulation/recording lead 20.

    [0049] Referring now to FIG. 6a and FIG. 6b, a side, top and sectional view show the two possible versions of FIGS. 5a (thick 130a) and 5b (thin 130b) where FIG. 6a exhibits housing frame 130a harboring depressions 132 and 133 and posts 136 and 137 and FIG. 6b exhibits posts 138 and 139. The thickness (130a) or thinness (130b) of the side load spring contact 140 and the housing frame 130 is illustrated by 160a and 160b at the bottom figures of FIG. 6a and FIG. 6b, wherein this width 160b of connector 130b may range from 0.013 inch to 0.060 inch (0.3 mm to 1.5 mm). The distance of the side load spring contact 140 from the center axis 180a and 180b is illustrated by distance 150, wherein this distance may range from 0.000 inch to 0.040 inch (0 mm to 1 mm).

    [0050] Further evidenced are side recess spaces 155 allowing for coil spring 140 movement outward and radially into said recess space 155 (as further depicted in FIGS. 8 and 9 upon insertion of lead 20) as well as upper and lower lead 20 guiding and coil spring 140 support protrusions 122 on each interior side of each coil spring 140 end and reciprocal demarcating shelf features 125 on each exterior coil spring 140 end of frame 130b. And whereas 130b requires a shelf 125-post 138, 139-convex protrusion 122 support structure, 130a's circular depressions 132, 133 serves as coil spring 140's end placement and support. Representationally, from top to bottom, both housing frame 130a (thick, left) and 130b (thin, right), are represented as (a) a lateral cross section, (b) a top view, (c) a side view and (d) a horizontal cross section.

    [0051] FIG. 7 is a sectional view showing the two possible versions of FIGS. 5 (130a and 130b) with the side load spring contact 140 removed. The housing 130a contains a depression 133 to hold and secure the side load spring contact 140 as illustrated in FIG. 7 left. The housing 130a contains a recess 200 to accommodate the displacement of the side load spring contact 140 (not shown) as the 16-channel stimulation/recording lead 20 is inserted into the side load spring contact assembly 130a. To further aid the capture of the side load coil spring 140 contact within housing 130a one or more post 136-139 (FIG. 6a and FIG. 6b) maybe added providing proper placement and securing with and without depressions 132 and 133.

    [0052] Referring to FIG. 8 and FIG. 9 an isometric view of the present invention before inserting the 16-channel stimulation/recording lead 20 exhibiting connector lead rings 88 into the side load spring contact assembly 110 and an isometric view of after the 16-channel stimulation/recording lead 20 is inserted into the side load spring contact assembly 110 (thin 130b) showing the first interconnect band (ring) 40 making contact with side load spring contact 140 resulting in deformation 150 outward (indicated by both right and left arrows).

    [0053] Referring to FIG. 10, side load spring contact assembly 130b shows the use of variable coil pitch and coil diameters 210 of the side load spring 140 of side load spring contact 130b as to better accommodate and secure stimulation/recording leads 20 insertion.

    [0054] The particular embodiments disclosed above are illustrative only, as the application may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. It is therefore evident that the particular embodiments disclosed above may be altered or modified, and all such variations are considered within the scope and spirit of the application. Accordingly, the protection sought herein is as set forth in the description. It is apparent that an application with significant advantages has been described and illustrated. Although the present application is shown in a limited number of forms, it is not limited to just these forms, but is amenable to various changes and modifications without departing from the spirit thereof.