High voltage connectors and electrodes for pulse generators

Inventors

Kreis, Mark P.Danitz, David J.Hinman, Cameron D.Finson, Sean N.

Assignees

Pulse Biosciences Inc

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Publication Number

US-11253695-B2

Patent

Publication Date

2022-02-22

Expiration Date


Abstract

A handheld, therapeutic electrode and connector that are compatible with high voltages from a pulse generator are disclosed. The electrode includes therapeutic terminals on a tip configured to deliver high voltage pulses safely to a patient. The electrode includes sleeves, bosses, wiring channels, and other features that maximize a minimum clearance distance (across non-conductive surfaces) and air clearance between conductive connectors themselves or the connectors and a user, thus preventing dangerous arcing. Internal surfaces and seams are taken into account. The connector and its mating outlet can include similar features to maximize clearance distance. Skirts, skirt holes, and finger stops are also employed, and they can be on either the connector or outlet, or the tip or handle of the electrode.

Core Innovation

The invention provides a high voltage therapeutic electrode apparatus having a tip with an insulative tip housing supporting a plurality of therapeutic terminals and connection terminals connected to the plurality of therapeutic terminals. The apparatus further includes a handle with an insulative handle housing and electrical connectors adapted to mate with the connection terminals of the tip and connected to an input cable. The apparatus also includes a sleeved receptacle and an insulative portion having a wiring channel within, where the insulative portion is in direct contact with the sleeved receptacle.

The tip and handle are configured to mate together such that one of the sleeved receptacle and insulative portion is within the tip and the other is within the handle. The mated tip/handle structure is sized and configured to provide a minimum clearance distance to prevent or minimize current leakage. The minimum clearance distance is provided between at least one of: connection terminals of the tip, or a connection terminal and a hand grip portion on the handle.

The invention relates to configuring clearance and creepage, and air clearances between high voltage conductive elements of the tip and connectors to prevent or minimize arcing. The described designs include insulating surfaces, internal seams, skirts, skirt holes, finger stops, standoffs, and insulative bosses or portions on the connector and electrode at the mating outlet, with structural features that define minimum clearance distance and minimum air or surface-path separation between conductive parts.

Claims Coverage

Independent claim clm-00001 covers an insulative tip and handle that mate while providing a minimum clearance distance to prevent or minimize current leakage, including leakage to a hand grip portion. Dependent claims further specify quantified minimum clearance and define how clearance distance is measured, and they add therapeutic electric-field timing and control monitoring refinements including pulse counting and storage.

Insulative tip housing with therapeutic terminals and connection terminals

A tip comprising an insulative tip housing supporting a plurality of therapeutic terminals and connection terminals connected with the plurality of therapeutic terminals.

Mating insulative handle housing connectors to mate with tip connection terminals

A handle comprising an insulative handle housing and electrical connectors adapted to mate with the connection terminals of the tip, the electrical connectors connected to an input cable.

Sleeved receptacle and insulative portion with wiring channel in direct contact

A sleeved receptacle and an insulative portion having a wiring channel within, the insulative portion being in direct contact with the sleeved receptacle.

Tip and handle mating positioning sleeved receptacle and insulative portion

One of the sleeved receptacle and insulative portion is within the tip and the other of the sleeved receptacle and insulative portion is within the handle, the tip and handle configured to mate together.

Minimum clearance distance sized to prevent or minimize current leakage

One or both of the insulative portion and the sleeved receptacle is sized and configured to provide a minimum clearance distance to prevent or minimize current leakage between at least one of: the connection terminals of the tip, or one of the connection terminals and a hand grip portion on the handle.

Minimum clearance distance at least 0.85 centimeters

The apparatus is configured so that the minimum clearance distance is at least 0.85 centimeters.

Minimum clearance distance measured through air or along an insulative surface path

The minimum clearance distance between conductive parts is measured either through air or along an insulative material surface path to prevent or minimize an arc.

Minimum clearance distance based on expected voltage

The minimum clearance distance is set at least partly on an expected voltage that will be applied to multiple therapeutic terminals.

Sub-microsecond pulsed electric fields

The apparatus is configured to apply sub-microsecond pulsed electric fields.

Sealed multi-channel tip wiring channels and insulative portions within the sleeved receptacle

The apparatus includes multiple tip wiring channels sealed from each other in an insulative tip housing and multiple insulative portions inside a sleeved receptacle, with each insulative portion forming part of a tip wiring channel.

Overall, the claims coverage centers on a handheld high voltage therapeutic electrode apparatus where an insulative tip and an insulative handle mate to establish a defined minimum clearance distance that prevents or minimizes current leakage, including leakage toward a hand grip portion. The covered refinements include quantifying the minimum clearance distance, specifying whether clearance is measured through air or along an insulative surface path to prevent or minimize arcing, tying the clearance to expected voltage, narrowing the therapy to sub-microsecond pulsed electric fields, and implementing sealed multi-channel wiring structures.

Stated Advantages

Prevents or minimizes current leakage between conductive parts, including between connection terminals and a hand grip portion.

Prevents or minimizes an arc by providing minimum clearance distance through air or along an insulating surface path.

Configures minimum clearance distance to be sized and configured to prevent or minimize leakage in the mated tip/handle structure.

Documented Applications

Therapeutic application involving tumor apoptosis and immunogenic apoptosis, including calreticulin.

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