US5672153A — Medical probe device and method

Claim 1

Independent Claim 199 words

A medical probe device for medical treatment of tissue at a treatment site through a natural body opening defined by a wall, comprising an elongate guide housing having proximal and distal extremities and having a passageway therein extending from the proximal extremity to the distal extremity along a longitudinal axis, a stylet mounted in the guide housing and having proximal and distal extremities, a handle mounted on the proximal extremity of the guide housing, means mounted on the proximal extremity of the guide housing and connected to the stylet for causing advancement of the stylet through the passageway, the distal extremity of the guide housing being in communication with the passageway and permitting the distal extremity of the stylet to be advanced out of the passageway sidewise at an angle with respect to the longitudinal axis into the tissue, the stylet including a conductive radio frequency electrode and a layer of insulating material coaxially disposed on the conductive radio frequency electrode so that a predetermined portion of the conductive radio frequency electrode is exposed in the tissue and the layer of insulating material protects the wall and expandable balloon means mounted on the guide housing for engaging the wall.

Claim 2

Dependent Claim 199 words

A medical probe device for medical treatment of tissue at a treatment site through a natural body opening defined by a wall, comprising an elongate guide housing having proximal and distal extremities and having a passageway therein extending from the proximal extremity to the distal extremity along a longitudinal axis, a stylet mounted in the guide housing and having proximal and distal extremities, a handle mounted on the proximal extremity of the guide housing, means mounted on the proximal extremity of the guide housing and connected to the stylet for causing advancement of the stylet through the passageway, the distal extremity of the guide housing being in communication with the passageway and permitting the distal extremity of the stylet to be advanced out of the passageway sidewise at an angle with respect to the longitudinal axis into the tissue, the stylet including a conductive radio frequency electrode and a layer of insulating material coaxially disposed on the conductive radio frequency electrode so that a predetermined portion of the conductive radio frequency electrode is exposed in the tissue and the layer of insulating material protects the wall and expandable balloon means mounted on the guide housing for engaging the wall.

Claim 3

Dependent Claim 78 words

A medical probe of claim 1 wherein the balloon means includes at least one dilation balloon and wherein the guide housing is provided with a fluid delivery lumen extending from the proximal extremity to the distal extremity of the guide housing so as to be in communication with the dilation balloon whereby the dilation balloon expands outwardly from the distal extremity of the guide housing when fluid is supplied from the fluid delivery lumen to the dilation balloon.

Claim 4

Dependent Claim 39 words

A medical probe of claim 1 wherein the guide housing is provided with a lumen extending in a direction parallel to the longitudinal axis, the lumen having a proximal opening for receiving a scope and a distal viewing port.

Claim 5

Dependent Claim 32 words

A medical probe of claim 3 wherein the scope includes viewing fibers, light fibers and a liquid supply connector for supplying a flushing liquid to the distal extremity of the guide housing.

Claim 6

Dependent Claim 19 words

A medical probe of claim 1 wherein the stylet comprises a tube having an axial lumen extending longitudinally therethrough.

Claim 7

Dependent Claim 13 words

A medical probe of claim 5 wherein the tube is made of nickel-titanium.

Claim 8

Dependent Claim 17 words

A medical probe of claim 5 wherein a temperature sensor is slidably disposed in the axial lumen.

Claim 9

Dependent Claim 23 words

A medical probe of claim 1 including a temperature sensor mounted on the balloon means for measuring the temperature adjacent the balloon means.

Claim 10

Dependent Claim 17 words

A medical probe of claim 1 including a temperature sensor carried by the layer of insulating material.

Claim 11

Dependent Claim 16 words

A medical probe of claim 1 together with an additional stylet mounted in the guide housing.

Claim 12

Dependent Claim 24 words

A medical probe of claim 10 wherein the guide housing includes two stylet ports positioned approximately in a plane perpendicular to the longitudinal axis.

Claim 13

Dependent Claim 20 words

A medical probe of claim 1 together with ultrasound imaging means carried by the distal extremity of the guide housing.

Claim 14

Dependent Claim 59 words

A medical probe of claim 1 together with a stylet guide means carried by the distal extremity of the guide housing for directing the stylet sidewise at an angle with respect to the longitudinal axis, the stylet guide means defining a stylet path from an axial orientation in the guide housing through a curved portion to a lateral orientation.

Claim 15

Dependent Claim 27 words

A medical probe of claim 13 wherein the curved portion has a radius which is sufficient to permit sliding deployment of the stylet in the stylet path.

Claim 16

Dependent Claim 52 words

A medical probe of claim 14 wherein the stylet guide means defines a stylet path terminating at a stylet port, the stylet path having a first curved portion which curves away from the stylet port and a second curved portion continuing from the first curved portion which curves towards the stylet port.

Claim 17

Dependent Claim 70 words

A medical probe of claim 13 wherein the stylet guide means defines at least two non-intersecting stylet paths from parallel axial orientations in the guide housing through curved portions to lateral orientations at respective stylet ports, the central axes of the stylet paths at the stylet ports forming an angle of up to 180° to one other and wherein a stylet is slidably disposed in each of the stylet paths.

Claim 18

Dependent Claim 24 words

A medical probe of claim 16 wherein the angle between the axes of the stylet paths at the stylet ports is less than 90°.

Claim 19

Dependent Claim 22 words

A medical probe of claim 16 wherein the angle between the axes of the stylet paths at the stylet ports is 60°.

Claim 20

Dependent Claim 16 words

A medical probe of claim 13 wherein the stylet guide means is made from a polycarbonate.

Claim 21

Dependent Claim 35 words

A medical probe of claim 1 in combination with at least one grounding plate, the grounding plate adapted to draw electrical energy passing from the conductive radio frequency electrode through target tissue to be ablated.

Claim 22

Dependent Claim 13 words

A medical probe of claim 1 wherein the stylet has a sharpened tip.

Claim 23

Dependent Claim 24 words

A medical probe of claim 1 wherein the layer of insulating material is an insulating sleeve coaxially mounted on the conductive radio frequency electrode.

Claim 24

Dependent Claim 22 words

A medical probe device of claim 22 wherein the insulating sleeve is mounted for longitudinal movement on the conductive radio frequency electrode.

Claim 25

Dependent Claim 59 words

A medical probe of claim 22 wherein the means for causing advancement of the stylet through the passageway includes means connected to the conductive radio frequency electrode and the insulating sleeve for causing relative movement between the insulating sleeve and the conductive radio frequency electrode so that a preselected length of the conductive radio frequency electrode can be exposed.

Claim 26

Dependent Claim 40 words

A medical probe of claim 24 wherein the means for causing relative movement between the insulating sleeve and the conductive radio frequency electrode include separate, adjacent manual movement means mounted on the handle for both separate and coordinated movement thereon.

Claim 27

Dependent Claim 56 words

A medical probe of claim 25 together with means for relating movement of the insulating sleeve to inflation of the balloon means which includes gauge means for measuring the inflation of the balloon means and graduations on the handle for accurate manual adjustment of the insulating sleeve in relation to the inflation of the balloon means.

Claim 28

Dependent Claim 22 words

A medical probe of claim 24 together with means for relating movement of the insulating sleeve to inflation of the balloon means.

Claim 29

Dependent Claim 54 words

A medical probe of claim 27 wherein the means for relating movement of the insulating sleeve to inflation of the balloon means includes automatic linkage means for automatically advancing the sleeve in relation to the expansion of the balloon means, the linkage means having gauge means for measuring the inflation of the balloon means.

Claim 30

Dependent Claim 24 words

A medical probe of claim 28 wherein the linkage means includes a pneumatic or hydraulic cylinder assembly linking the sleeve to the gauge means.

Claim 31

Dependent Claim 22 words

A medical probe of claim 28 wherein the linkage means includes a linear electric motor linking the sleeve to the gauge means.

Claim 32

Dependent Claim 30 words

A medical probe of claim 28 wherein the linkage means includes a servo motor linking the sleeve to the gauge means and electronic control means for controlling the servo motor.

Claim 33

Independent Claim 107 words

A method for medical treatment of a tissue mass comprising: (a) introducing a catheter along a body duct to a zone adjacent to the target tissue to be treated; (b) moving a flexible stylet comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve from the catheter through a catheter port and surrounding tissue into a target tissue to be treated; (c) exerting an outward force on the wall of the body duct by means of a force exerting means attached to the catheter; and (d) generating heat in the target tissue by passing electrical energy from an exposed area of the electrode into the target tissue.

Claim 34

Independent Claim 107 words

A method for medical treatment of a tissue mass comprising: (a) introducing a catheter along a body duct to a zone adjacent to the target tissue to be treated; (b) moving a flexible stylet comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve from the catheter through a catheter port and surrounding tissue into a target tissue to be treated; (c) exerting an outward force on the wall of the body duct by means of a force exerting means attached to the catheter; and (d) generating heat in the target tissue by passing electrical energy from an exposed area of the electrode into the target tissue.

Claim 35

Dependent Claim 29 words

A method of claim 32 comprising moving the non-conductive sleeve relative to the electrode to expose a preselected area of the electrode in the target tissue to be treated.

Claim 36

Dependent Claim 26 words

A method of claim 33 wherein the position of the non-conductive sleeve is adjusted in relation to the position of the wall of the body duct.

Claim 37

Dependent Claim 25 words

A method of claim 34 wherein the sleeve position is automatically adjusted by means of a control means obtaining information from the force exerting means.

Claim 38

Dependent Claim 32 words

A method of claim 32 wherein the force exerting means includes at least one inflatable balloon and wherein exerting a force on the wall of the body duct includes inflating the balloon.

Claim 39

Dependent Claim 20 words

A method of claim 32 wherein the catheter is positioned adjacent to the target tissue by use of ultrasound imaging.

Claim 40

Dependent Claim 17 words

A method of claim 32 wherein the catheter is positioned using a scope connected to the catheter.

Claim 41

Dependent Claim 35 words

A method of claim 32 wherein the stylet comprises a hollow tube and wherein the temperature of the target tissue being treated is monitored during the treatment using a temperature sensor disposed in the tube.

Claim 42

Independent Claim 113 words

A method for treatment of target tissue without exposing tissue surrounding the target tissue to destructive temperatures comprising: (a) advancing a flexible stylet through surrounding tissue into the target tissue to be ablated, the stylet being a radiofrequency electrode surrounded by a moveable non-conductive sleeve means for preventing significant transfer of energy from the electrode to tissue surrounding the sleeve; (b) moving the non-conductive sleeve means to expose a preselected portion of the electrode positioned in the target tissue and generating heat in the target tissue by causing electrical energy to flow between the preselected portion of the electrode and a second electrode; and (c) exerting a compressive force on the target tissue.

Claim 43

Independent Claim 113 words

A method for treatment of target tissue without exposing tissue surrounding the target tissue to destructive temperatures comprising: (a) advancing a flexible stylet through surrounding tissue into the target tissue to be ablated, the stylet being a radiofrequency electrode surrounded by a moveable non-conductive sleeve means for preventing significant transfer of energy from the electrode to tissue surrounding the sleeve; (b) moving the non-conductive sleeve means to expose a preselected portion of the electrode positioned in the target tissue and generating heat in the target tissue by causing electrical energy to flow between the preselected portion of the electrode and a second electrode; and (c) exerting a compressive force on the target tissue.

Claim 44

Independent Claim 30 words

A method of claims 40 further comprising adjusting the position of the sleeve means as the position of the tissue surrounding the target tissue changes due to the compressive force.

Claim 45

Independent Claim 143 words

A method for treating a target tissue such as the prostate of a patient comprising: (a) introducing a catheter into the urethra to a zone adjacent to the prostate target tissue to be treated; (b) moving two flexible stylets, each comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve which is axially moveable relative to the electrode, from the catheter through catheter ports and through the urethra wall and surrounding tissue into the prostate target tissue to be treated, the catheter ports having respective axes disposed relative to each other at an angle of less than 90°; (c) exerting an outwardly directed force on the urethra wall by means of at least one inflatable balloon attached to the catheter; and (d) generating heat in the target tissue by passing electrical energy from the exposed areas of the electrodes into the target tissue.

Claim 46

Independent Claim 143 words

A method for treating a target tissue such as the prostate of a patient comprising: (a) introducing a catheter into the urethra to a zone adjacent to the prostate target tissue to be treated; (b) moving two flexible stylets, each comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve which is axially moveable relative to the electrode, from the catheter through catheter ports and through the urethra wall and surrounding tissue into the prostate target tissue to be treated, the catheter ports having respective axes disposed relative to each other at an angle of less than 90°; (c) exerting an outwardly directed force on the urethra wall by means of at least one inflatable balloon attached to the catheter; and (d) generating heat in the target tissue by passing electrical energy from the exposed areas of the electrodes into the target tissue.

Claim 47

Dependent Claim 35 words

A method of claim 42 further comprising adjusting the position of the sleeve in relation to changes in position of the urethra wall due to the force exerted on the wall by the inflatable balloon.

Claim 48

Dependent Claim 19 words

A method of claim 42 wherein the axes are disposed relative to each other at an angle of 60°.

Claim 49

Dependent Claim 29 words

A method of claim 42 wherein the method includes retracting the sleeves relative to the electrodes to expose preselected portions of the electrodes positioned in the prostate target tissue.

Claim 50

Dependent Claim 31 words

A method of claim 42 wherein grounding plates are placed against the body of the patient to draw electrical energy passing from the electrodes through the target tissue to be ablated.

Claim 51

Dependent Claim 317 words

A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising a guide housing having proximal and distal extremities and having a passageway extending from the proximal extremity to the distal extremity, a stylet slidably mounted in the passageway of the guide housing, guide means carried by the distal extremity of the guide housing and in communication with the passageway for directing the stylet sidewise of the guide housing, the stylet including a flexible radio frequency electrode with a sharpened tip and an insulating sleeve slidably disposed on the radio frequency electrode, handle means mounted on the proximal extremity of the guide housing for introducing the distal extremity of the guide housing into the urethra to the vicinity of the prostate, the handle means including means secured to the stylet for advancing the stylet from the passageway of the guide housing to cause the sharpened tip of the radio frequency electrode and the insulating sleeve to penetrate the urethral wall and to extend into the tissue of the prostate with the insulating sleeve extending through the urethral wall, the handle means also including means for causing relative movement between the insulating sleeve and the radio frequency electrode to expose a predetermined length of the radio frequency electrode in the tissue of the prostate with the insulating sleeve extending through the urethral wall, means for supplying radio frequency energy to the radio frequency electrode to cause the temperature of the tissue of the prostate adjacent the predetermined length of the radio frequency electrode to be raised to cause destruction of cells in the tissue of the prostate, the guide housing having a fluid delivery lumen extending from the proximal extremity to the distal extremity of the guide housing and inflatable balloon means mounted on the distal extremity of the guide housing in communication with the fluid delivery lumen.

Claim 52

Dependent Claim 317 words

A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising a guide housing having proximal and distal extremities and having a passageway extending from the proximal extremity to the distal extremity, a stylet slidably mounted in the passageway of the guide housing, guide means carried by the distal extremity of the guide housing and in communication with the passageway for directing the stylet sidewise of the guide housing, the stylet including a flexible radio frequency electrode with a sharpened tip and an insulating sleeve slidably disposed on the radio frequency electrode, handle means mounted on the proximal extremity of the guide housing for introducing the distal extremity of the guide housing into the urethra to the vicinity of the prostate, the handle means including means secured to the stylet for advancing the stylet from the passageway of the guide housing to cause the sharpened tip of the radio frequency electrode and the insulating sleeve to penetrate the urethral wall and to extend into the tissue of the prostate with the insulating sleeve extending through the urethral wall, the handle means also including means for causing relative movement between the insulating sleeve and the radio frequency electrode to expose a predetermined length of the radio frequency electrode in the tissue of the prostate with the insulating sleeve extending through the urethral wall, means for supplying radio frequency energy to the radio frequency electrode to cause the temperature of the tissue of the prostate adjacent the predetermined length of the radio frequency electrode to be raised to cause destruction of cells in the tissue of the prostate, the guide housing having a fluid delivery lumen extending from the proximal extremity to the distal extremity of the guide housing and inflatable balloon means mounted on the distal extremity of the guide housing in communication with the fluid delivery lumen.

Claim 53

Dependent Claim 24 words

A medical probe as in claim 47 wherein the balloon means extends around only a portion of the distal extremity of the guide housing.

Claim 54

Dependent Claim 52 words

A medical probe as in claim 48 wherein the balloon means is expandable from said portion of the distal extremity of the guide housing and the stylet extends sidewise of the guide housing from another portion of the distal extremity of the guide housing which is generally opposite to said first-named portion.

Claim 55

Dependent Claim 23 words

A medical probe as in claim 47 wherein the stylet passes through the balloon means as it extends sidewise of the guide housing.

Claim 56

Dependent Claim 31 words

A medical probe as in claim 47 together with an additional stylet slidably mounted in the passageway of the guide housing which is of the same type as said first-named stylet.

Claim 57

Dependent Claim 15 words

A medical probe as in claim 47 wherein the balloon means includes an annular balloon.

Claim 58

Independent Claim 146 words

A method for the treatment of benign prostatic hypertrophy in the prostate of the human male having a bladder with a base and a penis with a urethra therein formed by a urethral wall extending into the base of the bladder along a longitudinal axis with the prostate having tissue surrounding the urethra near the base of the bladder, comprising dilating the urethra in the vicinity of the prostate with an expandable balloon disposed in the urethra, selecting a target volume of the tissue of the prostate beyond the urethral wall, introducing radio frequency energy through the urethral wall into the target volume of the tissue of the prostate to cause ablation of tissue in the target volume of the tissue in the prostate and protecting the urethral wall from ablation by the radio frequency energy supplied to the target volume of tissue in the prostate.

Claim 59

Independent Claim 146 words

A method for the treatment of benign prostatic hypertrophy in the prostate of the human male having a bladder with a base and a penis with a urethra therein formed by a urethral wall extending into the base of the bladder along a longitudinal axis with the prostate having tissue surrounding the urethra near the base of the bladder, comprising dilating the urethra in the vicinity of the prostate with an expandable balloon disposed in the urethra, selecting a target volume of the tissue of the prostate beyond the urethral wall, introducing radio frequency energy through the urethral wall into the target volume of the tissue of the prostate to cause ablation of tissue in the target volume of the tissue in the prostate and protecting the urethral wall from ablation by the radio frequency energy supplied to the target volume of tissue in the prostate.

Claim 60

Dependent Claim 76 words

A method as in claim 53 together with a radio frequency electrode formed of an electrically conductive material and a layer of insulating material surrounding at least a portion of the radio frequency electrode, further comprising the step of introducing the radio frequency electrode into the target volume of the tissue of the prostate with the layer of insulating material extending through the urethral wall, the radio frequency energy being supplied to the radio frequency electrode.

Claim 61

Dependent Claim 76 words

A method as in claim 54 wherein the layer of insulating material is an insulating sleeve slidably mounted on the radio frequency electrode, further comprising the step of causing relative sliding movement between the radio frequency electrode and the insulating sleeve to expose a preselected length of the radio frequency electrode corresponding to the size of the target volume while retaining the insulating sleeve in a position so that it continues to extend through the wall.

Claim 62

Independent Claim 188 words

A method for medical treatment of a prostate through a urethra formed by a urethral wall by the use of a catheter having a distal extremity carrying expandable balloon means and having a flexible radio frequency electrode with a sharpened tip and an insulating sleeve mounted on and surrounding the flexible radio frequency electrode to expose a predetermined length of the radio frequency electrode, the radio frequency electrode and the insulating sleeve being slidably mounted in the catheter and being movable through the distal extremity of the catheter, comprising introducing the catheter through the urethra to a region adjacent the prostate, expanding the balloon means in the urethra, advancing the flexible radio frequency electrode and the insulating sleeve using the sharpened tip to penetrate the urethral wall and pass through the urethral wall into the prostate, passing sufficient radio frequency energy through the radio frequency electrode to raise the temperature of the prostate adjacent the predetermined length of the radio frequency electrode to a temperature causing destruction of cells by ablation in the prostate while protecting the urethral wall by the insulating sleeve from the radio frequency energy.

Claim 63

Independent Claim 188 words

A method for medical treatment of a prostate through a urethra formed by a urethral wall by the use of a catheter having a distal extremity carrying expandable balloon means and having a flexible radio frequency electrode with a sharpened tip and an insulating sleeve mounted on and surrounding the flexible radio frequency electrode to expose a predetermined length of the radio frequency electrode, the radio frequency electrode and the insulating sleeve being slidably mounted in the catheter and being movable through the distal extremity of the catheter, comprising introducing the catheter through the urethra to a region adjacent the prostate, expanding the balloon means in the urethra, advancing the flexible radio frequency electrode and the insulating sleeve using the sharpened tip to penetrate the urethral wall and pass through the urethral wall into the prostate, passing sufficient radio frequency energy through the radio frequency electrode to raise the temperature of the prostate adjacent the predetermined length of the radio frequency electrode to a temperature causing destruction of cells by ablation in the prostate while protecting the urethral wall by the insulating sleeve from the radio frequency energy.

Claim 64

Dependent Claim 60 words

A method as in claim 56 wherein the radio frequency electrode and the insulating sleeve are movable relative to each other, further comprising the step of establishing a relationship between the radio frequency electrode and the insulating sleeve so that a predetermined portion of the radio frequency electrode extends out of the insulating sleeve and is exposed in the prostate.

Claim 65

Dependent Claim 35 words

A method as in claim 56 further comprising the step of expanding the balloon means along one side of the distal extremity of the catheter so as to urge the catheter against the urethral wall.

Claim 66

Dependent Claim 24 words

A method as in claim 56 wherein the advancing step includes advancing the radio frequency electrode and the insulating sleeve through the balloon means.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2000-09-29	2001-03-31	2001-09-30	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2004-09-29	2005-03-31	2005-09-30	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2008-09-29	2009-03-31	2009-09-30	$7700.00	Window Closed / Lapsed

Medical probe device and method

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