US5433708A — Method and device for thermal ablation having imp…

Claim 1

Independent Claim 130 words

A thermal ablation catheter comprising: an elongate member adapted for insertion into a hollow body cavity; said elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends; a convective heating element disposed over a predetermined length of the distal end of the elongate member and exposed to an environment external to said catheter; means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element; and means for distributing a heat transfer fluid from the lumen to the circulation region between the member surface and the heating element, wherein the heating element is capable of heating said heat transfer fluid to a temperature above 45° C.

Claim 2

Dependent Claim 130 words

A thermal ablation catheter comprising: an elongate member adapted for insertion into a hollow body cavity; said elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends; a convective heating element disposed over a predetermined length of the distal end of the elongate member and exposed to an environment external to said catheter; means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element; and means for distributing a heat transfer fluid from the lumen to the circulation region between the member surface and the heating element, wherein the heating element is capable of heating said heat transfer fluid to a temperature above 45° C.

Claim 3

Dependent Claim 18 words

A thermal ablation catheter as is in claim 1, wherein the elongate member is at least partly flexible.

Claim 4

Dependent Claim 20 words

A thermal ablation catheter as in claim 1, wherein the heating element is an electrically resistive coil having spaced-apart windings.

Claim 5

Dependent Claim 38 words

A thermal ablation catheter as in claim 1, wherein the means for suspending comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation region.

Claim 6

Dependent Claim 31 words

A thermal ablation catheter as in claim 4, wherein the means for distributing a heat transfer fluid comprises a plurality of ports in the elongate member opening into the trough regions.

Claim 7

Dependent Claim 56 words

A thermal ablation catheter as in claim 5, wherein the heating element is a coiled wire having a diameter in the range from about 0.05 mm to 0.25 mm, wherein adjacent windings of the coil are spaced-apart by from 0.5 to 2 wire diameters to permit free flow of heat transfer fluid through the heating element.

Claim 8

Dependent Claim 32 words

A thermal ablation catheter as in claim 1, further comprising a cage structure surrounding the heating element and means for expanding the cage structure at the distal end of the elongate member.

Claim 9

Dependent Claim 34 words

A thermal ablation catheter as in claim 7, wherein the means for expanding a cage is an introducer sheath having a proximal end, a distal end, and the expandable cage at its distal end.

Claim 10

Dependent Claim 88 words

A thermal ablation system comprising: a catheter including an elongate member having proximal and distal ends an axial lumen, a resistive heating element mounted on an exterior surface over a predetermined length at the distal end of the elongate member, and a plurality of apertures extending radially outward from the axial lumen within the predetermined length of the exterior surface; a power supply connected to the resistive heating element; and means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element in two directions.

Claim 11

Dependent Claim 88 words

A thermal ablation system comprising: a catheter including an elongate member having proximal and distal ends an axial lumen, a resistive heating element mounted on an exterior surface over a predetermined length at the distal end of the elongate member, and a plurality of apertures extending radially outward from the axial lumen within the predetermined length of the exterior surface; a power supply connected to the resistive heating element; and means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element in two directions.

Claim 12

Dependent Claim 61 words

A thermal ablation system as in claim 9, further comprising: an introducer sheath having a proximal end, a distal end, an axial lumen for receiving the elongate member of the catheter, and an expandable cage at its distal end, wherein the expandable cage will surround the heating element when the catheter is in place in the axial lumen of the sheath.

Claim 13

Dependent Claim 20 words

A thermal ablation system as in claim 10, further comprising at least one temperature sensing element on the expandable cage.

Claim 14

Dependent Claim 25 words

A thermal ablation system as in claim 11, wherein the temperature sensing element is at a point of maximum radial expansion on the expandable cage.

Claim 15

Dependent Claim 32 words

A thermal ablation system as in claim 9, wherein the means for inducing an oscillatory flow includes: an oscillatory pump connected to a proximal end of the lumen in the elongate member.

Claim 16

Dependent Claim 23 words

A thermal ablation system as in claim 13, wherein the oscillatory pump is a syringe connected to the lumen of the elongate member.

Claim 17

Dependent Claim 49 words

A thermal ablation system as in claim 9, wherein the resistive heating element comprises a coil having spaced-apart windings and the catheter further includes means for suspending the coil away from an exterior surface of the elongate member to form a circulation region between the surface and the coil.

Claim 18

Dependent Claim 40 words

A thermal ablation system as in claim 15, wherein the means for suspending the coil comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation regions.

Claim 19

Independent Claim 151 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heating element is directly exposed to fluid within the organ; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means past the heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 20

Independent Claim 151 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heating element is directly exposed to fluid within the organ; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means past the heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 21

Dependent Claim 37 words

A method as in claim 17, further comprising: expanding a cage structure within the hollow body organ; and positioning the heating element of the catheter within the expanded cage structure prior to heating the thermally conductive medium.

Claim 22

Dependent Claim 22 words

A method as in claim 18, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

Claim 23

Dependent Claim 23 words

A method as in claim 19, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

Claim 24

Dependent Claim 23 words

A method as in claim 17, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

Claim 25

Dependent Claim 24 words

A method as in claim 17, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

Claim 26

Dependent Claim 24 words

A method as in claim 17, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

Claim 27

Dependent Claim 20 words

A method as in claim 17, wherein the preselected temperature is in the range from 45° C. to 70° C.

Claim 28

Dependent Claim 63 words

A method as in claim 17, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50° C. to 65° C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

Claim 29

Dependent Claim 120 words

A thermal ablation catheter comprising: an elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends; a heating element disposed over a predetermined length of the distal end of the elongate member; means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element, wherein the means for suspending comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation region; and means for distributing a heat transfer fluid from the lumen to the region between the member surface and the heating element.

Claim 30

Dependent Claim 120 words

A thermal ablation catheter comprising: an elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends; a heating element disposed over a predetermined length of the distal end of the elongate member; means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element, wherein the means for suspending comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation region; and means for distributing a heat transfer fluid from the lumen to the region between the member surface and the heating element.

Claim 31

Dependent Claim 18 words

A thermal ablation catheter as is in claim 26, wherein the elongate member is at least partly flexible.

Claim 32

Dependent Claim 18 words

A thermal ablation catheter as in claim 26, wherein the heating element is a coil having spaced-apart windings.

Claim 33

Dependent Claim 31 words

A thermal ablation catheter as in claim 26, wherein the means for distributing a heat transfer fluid comprises a plurality of ports in the elongate member opening into the trough regions.

Claim 34

Dependent Claim 56 words

A thermal ablation catheter as in claim 29, wherein the heating element is a coiled wire having a diameter in the range from about 0.05 mm to 0.25 mm, wherein adjacent windings of the coil are spaced-apart by from 0.5 to 2 wire diameters to permit free flow of heat transfer fluid through the heating element.

Claim 35

Dependent Claim 32 words

A thermal ablation catheter as in claim 26, further comprising a cage structure surrounding the heating element and means for expanding the cage structure at the distal end of the elongate member.

Claim 36

Dependent Claim 34 words

A thermal ablation catheter as in claim 31, wherein the means for expanding a cage is an introducer sheath having a proximal end, a distal end, and the expandable cage at its distal end.

Claim 37

Dependent Claim 98 words

A thermal ablation system comprising: a catheter including an elongate member adapted for insertion into a hollow body cavity; said elongate member having proximal and distal ends and a resistive heating element having spaced-apart windings mounted on an exterior surface at the distal end of the elongate member; means for suspending the coil away from an exterior surface of the elongate member to form a circulation region between the surface and the coil; a power supply connected to the resistive heating element; and means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element.

Claim 38

Dependent Claim 98 words

A thermal ablation system comprising: a catheter including an elongate member adapted for insertion into a hollow body cavity; said elongate member having proximal and distal ends and a resistive heating element having spaced-apart windings mounted on an exterior surface at the distal end of the elongate member; means for suspending the coil away from an exterior surface of the elongate member to form a circulation region between the surface and the coil; a power supply connected to the resistive heating element; and means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element.

Claim 39

Dependent Claim 62 words

A thermal ablation system as in claim 33, further comprising: an introducer sheath having a proximal end, a distal end, and an axial lumen for receiving the elongate member of the catheter, and an expandable cage at its distal end, wherein the expandable cage will surround the heating element when the catheter is in place in the axial lumen of the sheath.

Claim 40

Dependent Claim 20 words

A thermal ablation system as in claim 34, further comprising at least one temperature sensing element on the expandable cage.

Claim 41

Dependent Claim 25 words

A thermal ablation system as in claim 35, wherein the temperature sensing element is at a point of maximum radial expansion on the expandable cage.

Claim 42

Dependent Claim 61 words

A thermal ablation system as in claim 33, wherein the means for inducing an oscillatory flow includes: a lumen extending from the proximal end to the distal end of the elongate member; an oscillatory pump connected to the proximal end of the lumen; and a plurality of ports in the elongate member opening from the lumen and through the heating element.

Claim 43

Dependent Claim 23 words

A thermal ablation system as in claim 37, wherein the oscillatory pump is a syringe connected to the lumen of the elongate member.

Claim 44

Dependent Claim 40 words

A thermal ablation system as in claim 33, wherein the means for suspending the coil comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation regions.

Claim 45

Independent Claim 147 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ; expanding a cage structure within the hollow body organ; positioning the heating element of the catheter within the expanded cage structure; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 46

Independent Claim 147 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ; expanding a cage structure within the hollow body organ; positioning the heating element of the catheter within the expanded cage structure; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 47

Dependent Claim 22 words

A method as in claim 40, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

Claim 48

Dependent Claim 23 words

A method as in claim 41, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

Claim 49

Dependent Claim 23 words

A method as in claim 40, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

Claim 50

Dependent Claim 24 words

A method as in claim 40, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

Claim 51

Dependent Claim 24 words

A method as in claim 40, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

Claim 52

Dependent Claim 20 words

A method as in claim 40, wherein the preselected temperature is in the range from 45° C. to 70° C.

Claim 53

Dependent Claim 63 words

A method as in claim 40, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50° C. to 65° C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

Claim 54

Independent Claim 139 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ and the fluid distributing means directs fluid generally radially through the heating element; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 55

Independent Claim 139 words

A method for ablating a hollow body organ, said method comprising: percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ and the fluid distributing means directs fluid generally radially through the heating element; introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ; heating the thermally conductive medium within the hollow body organ using the heating element; and alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 56

Dependent Claim 37 words

A method as in claim 48, further comprising: expanding a cage structure within the hollow body organ; and positioning the heating element of the catheter within the expanded cage structure prior to heating the thermally conductive medium.

Claim 57

Dependent Claim 22 words

A method as in claim 49, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

Claim 58

Dependent Claim 23 words

A method as in claim 50, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

Claim 59

Dependent Claim 23 words

A method as in claim 48, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

Claim 60

Dependent Claim 24 words

A method as in claim 48, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

Claim 61

Dependent Claim 24 words

A method as in claim 48, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

Claim 62

Dependent Claim 20 words

A method as in claim 48, wherein the preselected temperature is in the range from 45° C. to 70° C.

Claim 63

Dependent Claim 63 words

A method as in claim 48, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50° C. to 65° C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

Claim 64

Independent Claim 105 words

A method for ablating a hollow body organ, said method comprising: introducing a catheter into the interior of said hollow body organ; introducing a thermally conductive medium into the hollow body organ so that the medium is unconstrained and in direct thermal conduct with the interior wall of the organ; and alternately aspirating and expelling volumes of the thermally conductive medium through the catheter and past a heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 65

Independent Claim 105 words

A method for ablating a hollow body organ, said method comprising: introducing a catheter into the interior of said hollow body organ; introducing a thermally conductive medium into the hollow body organ so that the medium is unconstrained and in direct thermal conduct with the interior wall of the organ; and alternately aspirating and expelling volumes of the thermally conductive medium through the catheter and past a heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

Claim 66

Dependent Claim 12 words

A method as in claim 57, wherein the catheter is introduced percutaneously.

Claim 67

Dependent Claim 16 words

A method as in claim 57, wherein the thermally conductive medium is introduced through the catheter.

Claim 68

Dependent Claim 18 words

A method as in claim 57, wherein the heating element is on the distal end of the catheter.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1998-07-17	1999-01-16	1999-07-18	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2002-07-17	2003-01-16	2003-07-18	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2006-07-17	2007-01-16	2007-07-18	$7700.00	Window Closed / Lapsed

Method and device for thermal ablation having improved heat transfer

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