US6312428B1 — Methods and apparatus for therapeutic cauterizati…

Claim 1

Independent Claim 173 words

Apparatus connectable with a power source to provide current flow based therapeutic cauterization of a volume of biological tissue, exhibiting a predetermined shape and size, the apparatus comprising: a base having a longitudinal axis; a distal electrode disposed on the base and having a surface area and configuration, energizable for effecting said therapeutic cauterization of said volume of biological tissue by deriving a current flow substantially only within a zone of current flow encompassing and conforming in correspondence with said tissue predetermined shape and size a proximal electrode disposed on the base and having a surface area and configuration energizable for effecting said therapeutic cauterization in operational association with said distal electrode, and being spaced and electrically isolated a length therefrom a distance corresponding with and establishing along said length said current flow with a shape of said zone encompassing and conforming in correspondence with said tissue shape and size; and control means for controllably, electrically coupling said distal electrode and said proximal electrode with said power source to effect said energization thereof.

Claim 2

Dependent Claim 173 words

Apparatus connectable with a power source to provide current flow based therapeutic cauterization of a volume of biological tissue, exhibiting a predetermined shape and size, the apparatus comprising: a base having a longitudinal axis; a distal electrode disposed on the base and having a surface area and configuration, energizable for effecting said therapeutic cauterization of said volume of biological tissue by deriving a current flow substantially only within a zone of current flow encompassing and conforming in correspondence with said tissue predetermined shape and size a proximal electrode disposed on the base and having a surface area and configuration energizable for effecting said therapeutic cauterization in operational association with said distal electrode, and being spaced and electrically isolated a length therefrom a distance corresponding with and establishing along said length said current flow with a shape of said zone encompassing and conforming in correspondence with said tissue shape and size; and control means for controllably, electrically coupling said distal electrode and said proximal electrode with said power source to effect said energization thereof.

Claim 3

Dependent Claim 18 words

The apparatus as defined in claim 1 , wherein the proximal electrode is coaxial with the distal electrode.

Claim 4

Dependent Claim 21 words

The apparatus as defined in claim 2 , wherein the distal electrode comprises a sharpened end of a solid cylindrical shaft.

Claim 5

Dependent Claim 17 words

The apparatus as defined in claim 2 , wherein the distal electrode comprises a hollow cylindrical shaft.

Claim 6

Dependent Claim 28 words

The apparatus as defined in claim 4 , wherein the distal electrode has a sharpened edge to facilitate introduction and advancement of the energy applicator into biological tissue.

Claim 7

Dependent Claim 37 words

The apparatus as defined in claim 4 , wherein an extraction device is located within the hollow cylindrical shaft, the extraction device being operable in combination with the energy applicator to sever a sample of biological tissue.

Claim 8

Dependent Claim 88 words

The apparatus as defined in claim 1 , wherein said control means comprises: control circuitry including a current detector that measures a current flowing between the proximal and distal electrodes during said energization, the current detector measuring a first current value upon initial energization of said distal and proximal electrodes and a second current value at an interval following said initial energization thereof; and wherein the control circuitry terminates activation of said electrodes when the present current value falls to a predetermined percentage of the initial current value.

Claim 9

Dependent Claim 36 words

The apparatus as defined in claim 7 , wherein the control circuitry terminates energization of said electrodes when a present current value falls to a value between five and thirty percent of the initial current value.

Claim 10

Dependent Claim 24 words

The apparatus as defined in claim 1 , wherein the proximal electrode is slidably adjustable along said axis with respect to the distal electrode.

Claim 11

Dependent Claim 24 words

The apparatus as defined in claim 1 , comprising multiple said proximal electrodes that may be selectively energized in combination with the distal electrode.

Claim 12

Dependent Claim 43 words

The apparatus as defined in claim 1 , wherein said control means further comprises: a timer that measures a preset period of time from energization of said electrodes; and circuitry that terminates supply of power to said electrodes when said preset period elapses.

Claim 13

Dependent Claim 55 words

The apparatus as defined in claim 1 , wherein said control means further comprises: a coding element; and circuitry that measures a value of a parameter of the coding element to determine an upper power or current limit value corresponding to a maximum power density or current density to be applied to the biological tissue.

Claim 14

Dependent Claim 40 words

The apparatus as defined in claim 1 , further comprising an expandable member having a contracted diameter for insertion into the biological tissue and an expanded diameter, one of the proximal electrode and distal electrode disposed on the expandable member.

Claim 15

Dependent Claim 34 words

The apparatus as defined in claim 13 , further comprising means for injecting a pressurizing fluid into the expandable member, the pressurizing fluid moderating the temperature of the electrode disposed on the expandable member.

Claim 16

Dependent Claim 70 words

The apparatus of claim 1 , in which: said proximal electrode comprises an expandable member having a contracted diameter for insertion to a select position with respect to said biological tissue and actuable to an expanded diameter defining a proximal outer surface when operationally located with respect to said tissue predetermined volume; and said proximal electrode surface area is disposed upon at least a portion of said proximal outer surface.

Claim 17

Dependent Claim 67 words

The apparatus of claim 15 , in which: said distal electrode comprises an expandable member having a contracted diameter for insertion to a select position with respect to said biological tissue and expandable to an expanded diameter defining a distal outer surface when operationally located with respect to said tissue; and said distal electrode surface area is disposed upon at least a portion of said outer surface.

Claim 18

Dependent Claim 94 words

The apparatus of claim 1 , in which: said proximal electrode is disposed about said axis and said surface area thereof extends about said axis along a length, L PE ; said distal electrode is disposed about said axis and extends therealong a length, L DE ; said proximal electrode is spaced along said axis from said distal electrode a length, L ES ; and said lengths L PE , L DE and L ES are selected to effect said derivation of said zone of current flow encompassing said tissue predetermined shape and size.

Claim 19

Dependent Claim 58 words

The apparatus of claim 17 , in which: said distal electrode is configured having a maximum diameter, D DE ; said proximal electrode is configured having a diameter, D PE ; and said diameter D DE and D PE are selected to effect said derivation of said zone of current flow encompassing said tissue predetermined shape and size.

Claim 20

Dependent Claim 134 words

Apparatus connectible with a power source for providing current flow based therapeutic cauterization of a volume of biological tissue exhibiting a predetermined shape and size, the apparatus comprising: an energy applicator having unique electrode parameters that provide cauterization of a predetermined volume of biological tissue when said energy applicator is activated, said applicator comprising: a shaft having a longitudinal axis; first and second mutually electrically isolated electrodes disposed on the shaft exhibiting respective surface areas and spaced apart a distance along the longitudinal axis, the distance between the first and second electrodes and said respective surface areas determining a current flow substantially only within a zone of size and shape encompassing and conforming with said volume predetermined shape and size of biological tissue; and a handle that couples said applicator to the power source.

Claim 21

Dependent Claim 134 words

Apparatus connectible with a power source for providing current flow based therapeutic cauterization of a volume of biological tissue exhibiting a predetermined shape and size, the apparatus comprising: an energy applicator having unique electrode parameters that provide cauterization of a predetermined volume of biological tissue when said energy applicator is activated, said applicator comprising: a shaft having a longitudinal axis; first and second mutually electrically isolated electrodes disposed on the shaft exhibiting respective surface areas and spaced apart a distance along the longitudinal axis, the distance between the first and second electrodes and said respective surface areas determining a current flow substantially only within a zone of size and shape encompassing and conforming with said volume predetermined shape and size of biological tissue; and a handle that couples said applicator to the power source.

Claim 22

Dependent Claim 17 words

The apparatus as defined in claim 19 , wherein the first and second electrodes are coaxially aligned.

Claim 23

Dependent Claim 13 words

The apparatus as defined in claim 19 wherein the shaft includes a lumen.

Claim 24

Dependent Claim 32 words

The apparatus as defined in claim 21 , further comprising a biopsy cannula disposed within the lumen, the biopsy cannula operable to isolate by severance and remove a sample of biological tissue.

Claim 25

Dependent Claim 26 words

The apparatus as defined in claim 19 wherein the shaft has a sharpened tip to facilitate introduction and advancement of the energy applicator into biological tissue.

Claim 26

Dependent Claim 76 words

The apparatus as defined in claim 19 , further comprising: a current detector that measures a current level between the first and second electrodes, the current detector measuring an initial current value upon activation of the energy applicator and a present current value following initial activation of the energy applicator; and circuitry for terminating the supply of power to the energy applicator when the present current value reaches a predetermined percentage of the initial current value.

Claim 27

Dependent Claim 36 words

The apparatus as defined in claim 24 , wherein the supply of power to the energy applicator is terminated when the present current value is between about five and thirty percent of the initial current value.

Claim 28

Dependent Claim 21 words

The apparatus as defined in claim 19 , wherein the second electrode is slidably adjustable with respect to the first electrode.

Claim 29

Dependent Claim 41 words

The apparatus as defined in claim 19 , further comprising: a timer that measures a preset period of time from activation of the energy applicator; and circuitry for terminating supply of power to the energy applicator when the preset period elapses.

Claim 30

Dependent Claim 57 words

The apparatus as defined in claim 19 , wherein the energy applicator contains a coding element, the apparatus further comprising circuitry that measures a value of a parameter of the coding element to determine an upper power or current limit value corresponding to a maximum power density or current density to be applied to the biological tissue.

Claim 31

Dependent Claim 38 words

The apparatus as defined in claim 19 , wherein said applicator further comprises an expandable member having a contracted diameter for insertion into the biological tissue and an expanded diameter, the first electrode disposed on the expandable member.

Claim 32

Dependent Claim 33 words

The apparatus as defined in claim 29 wherein the energy applicator further comprises means for injecting a pressurizing fluid into the expandable member, the pressurizing fluid moderating the temperature of the first electrode.

Claim 33

Independent Claim 166 words

A method for cauterizing a volume of biological tissue exhibiting a given shape and size comprising: providing apparatus comprising an energy applicator having first and second electrodes disposed along a base having a longitudinal axis and exhibiting unique electrode parameters when activated, that provide a cauterization zone of current therebetween corresponding with said given size and shape of said volume of biological tissue; determining the size and shape of said volume of biological tissue; selecting the spacing along said axis between said first and second electrodes as a said unique electrode parameter to derive a said cauterization zone of current substantially encompassing and conforming with said determined size and shape of said volume of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into a location with respect to said volume of biological tissue effective to apply said zone of current substantially only thereto; and activating the energy applicator for a period of time to cauterize the volume of biological tissue.

Claim 34

Independent Claim 166 words

A method for cauterizing a volume of biological tissue exhibiting a given shape and size comprising: providing apparatus comprising an energy applicator having first and second electrodes disposed along a base having a longitudinal axis and exhibiting unique electrode parameters when activated, that provide a cauterization zone of current therebetween corresponding with said given size and shape of said volume of biological tissue; determining the size and shape of said volume of biological tissue; selecting the spacing along said axis between said first and second electrodes as a said unique electrode parameter to derive a said cauterization zone of current substantially encompassing and conforming with said determined size and shape of said volume of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into a location with respect to said volume of biological tissue effective to apply said zone of current substantially only thereto; and activating the energy applicator for a period of time to cauterize the volume of biological tissue.

Claim 35

Dependent Claim 78 words

The method as defined in claim 31 , further comprising steps of: detecting an initial current value of current supplied to said first and second electrodes of the energy applicator upon initial activation of the energy applicator; detecting a present current value during continued activation of the first and second electrode of the energy applicator; and terminating supply of power to the energy applicator when the present current value reaches a predetermined percentage of the initial current value.

Claim 36

Dependent Claim 52 words

The method as defined in claim 31 , further comprising steps of: measuring a preset time period from initial activation of the first and second electrode of the energy applicator; and terminating supply of power to the first and second electrode of the energy applicator when the preset period of time elapses.

Claim 37

Independent Claim 174 words

A method for cauterizing biological tissue comprising: providing apparatus comprising a handle and a plurality of energy applicators, each one of the plurality of energy applicators having unique electrode parameters that provide cauterization of correspondingly different predetermined volumes of biological tissue; determining the size and shape of an abnormal mass of biological tissue; selecting an energy applicator having electrode parameters that provide cauterization of a predetermined volume of biological tissue suitable for cauterizing a volume the size and shape of the abnormal mass of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into the abnormal mass of biological tissue; activating the energy applicator for a period of time to cauterize the abnormal mass of biological tissue; and wherein the step of selecting the electrode parameters includes selecting an energy applicator having at least a first electrode disposed upon an expandable member, the method further comprising, before the step of activating the energy applicator, a step of expanding the expandable member to increase a surface area of the electrode.

Claim 38

Independent Claim 174 words

A method for cauterizing biological tissue comprising: providing apparatus comprising a handle and a plurality of energy applicators, each one of the plurality of energy applicators having unique electrode parameters that provide cauterization of correspondingly different predetermined volumes of biological tissue; determining the size and shape of an abnormal mass of biological tissue; selecting an energy applicator having electrode parameters that provide cauterization of a predetermined volume of biological tissue suitable for cauterizing a volume the size and shape of the abnormal mass of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into the abnormal mass of biological tissue; activating the energy applicator for a period of time to cauterize the abnormal mass of biological tissue; and wherein the step of selecting the electrode parameters includes selecting an energy applicator having at least a first electrode disposed upon an expandable member, the method further comprising, before the step of activating the energy applicator, a step of expanding the expandable member to increase a surface area of the electrode.

Claim 39

Independent Claim 174 words

A method for cauterizing biological tissue comprising: providing apparatus comprising a handle and a plurality of energy applicators, each one of the plurality of energy applicators having unique electrode parameters that provide cauterization of correspondingly different predetermined volumes of biological tissue; determining the size and shape of an abnormal mass of biological tissue; selecting an energy applicator having electrode parameters that provide cauterization of a predetermined volume of biological tissue suitable for cauterizing a volume the size and shape of the abnormal mass of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into the abnormal mass of biological tissue; activating the energy applicator for a period of time to cauterize the abnormal mass of biological tissue; and further comprising steps of: inserting an extraction device through the lumen and into the abnormal mass of biological tissue; extending the energy applicator into the biological tissue to gather a tissue sample in the extraction device; and retrieving the extraction device through the lumen after the tissue sample has been gathered.

Claim 40

Independent Claim 174 words

A method for cauterizing biological tissue comprising: providing apparatus comprising a handle and a plurality of energy applicators, each one of the plurality of energy applicators having unique electrode parameters that provide cauterization of correspondingly different predetermined volumes of biological tissue; determining the size and shape of an abnormal mass of biological tissue; selecting an energy applicator having electrode parameters that provide cauterization of a predetermined volume of biological tissue suitable for cauterizing a volume the size and shape of the abnormal mass of biological tissue; coupling the energy applicator to a power source; inserting the energy applicator into the abnormal mass of biological tissue; activating the energy applicator for a period of time to cauterize the abnormal mass of biological tissue; and further comprising steps of: inserting an extraction device through the lumen and into the abnormal mass of biological tissue; extending the energy applicator into the biological tissue to gather a tissue sample in the extraction device; and retrieving the extraction device through the lumen after the tissue sample has been gathered.

Claim 41

Dependent Claim 33 words

The method of claim 31 wherein said step of selecting the spacing between said first and second electrodes includes the step of selecting the surface areas thereof as a said unique electrode parameter.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2004-11-05	2005-05-07	2005-11-06	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2008-11-05	2009-05-07	2009-11-06	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2012-11-05	2013-05-07	2013-11-06	$7700.00	Window Closed / Lapsed

Methods and apparatus for therapeutic cauterization of predetermined volumes of biological tissue

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