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US6081749A Expired / Lapsed US ⏱️ 0.0 years remaining

Noninvasive devices, methods, and systems for shrinking of tissues

Assignee: Verathon Inc
•
Filing: 1997-08-13
•
Granted: 2000-06-27
•
Expires: 2017-08-13
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Abstract

Abstract The invention provides improved devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy gently heats fascia and other collagenated support tissues, causing them to contract. The energy will preferably be applied between a pair of large plate electrodes having cooled flat electrode surfaces. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia.

Inventors

  • 👤 Frank Ingle
  • 👤 Garry Carter

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 16:25
CPC Classifications
A; A61; A61B; A61B18/00; A61B18/04; A61B18/12; A61B18/14; A61B18/1485; A61B18/18; A61B18/1815; A61B17/00; A61B2017/00017; A61B2017/00022; A61B2017/00084; A61B17/00234; A61B2017/00292; A61B2017/003; A61B2018/00005; A61B2018/00011; A61B2018/00023; A61B2018/00053; A61B2018/0016; A61B2018/00214; A61B2018/0022; A61B2018/00315; A61B2018/00505; A61B2018/00517; A61B2018/00523; A61B2018/00553; A61B2018/00636; A61B2018/00773; A61B2018/00791; A61B18/1206; A61B2018/1246; A61B2018/1253; A61B2018/126; A61B2018/1273; A61B2018/1467; A61B2018/1472; A61B90/00; A61B90/36; A61B90/37; A61B2090/378; A61B2090/3782; A61B2218/00; A61B2218/001; A61B2218/002; A61N; A61N7/00; A61N7/02

Claims Analysis

Total Claims: 33
Claim 1
Independent Claim 156 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the target tissue comprising a collagenous pelvic support tissue, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue, the probe body having a size and configuration suitable for transvaginal insertion, the electrode surface segments oriented for heating the target tissue through a vaginal wall so that the collagenous pelvic support tissue inhibits incontinence; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature.
Claim 2
Dependent Claim 156 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the target tissue comprising a collagenous pelvic support tissue, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue, the probe body having a size and configuration suitable for transvaginal insertion, the electrode surface segments oriented for heating the target tissue through a vaginal wall so that the collagenous pelvic support tissue inhibits incontinence; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature.
Claim 3
Dependent Claim 26 words
A probe as claimed in claim 1, further comprising an ultrasound transducer disposable adjacent the intermediate tissue to facilitate aligning the probe with the target tissue.
Claim 4
Dependent Claim 39 words
A probe as claimed in claim 2, further comprising a needle extendable from the probe within a field of view of the ultrasound transducer, the needle coupled to a temperature sensor for monitoring a temperature of the target tissue.
Claim 5
Dependent Claim 28 words
A probe as claimed in claim 1, wherein the control system is adapted to effect shrinkage of the target tissue, the target tissue comprising a collagenous support tissue.
Claim 6
Dependent Claim 42 words
A probe as claimed in claim 4, further comprising a tissue temperature sensor coupled to the control system, the control system limiting a radiofrequency energy applied to the electrode surface segments in response to a tissue temperature signal from the temperature sensor.
Claim 7
Dependent Claim 50 words
A probe as claimed in claim 4, wherein the control system limits the energy so that the treatment temperature of the target tissue is in a range from about 60 C to about 110 C while the intermediate tissue engaged by the electrode surface segments remains below about 45 C.
Claim 8
Dependent Claim 42 words
A probe as claimed in claim 6, wherein the control system limits a heating time and heating energy so that the target tissue is at the treatment temperature for a time in a range from about 10 seconds to about 2 minutes.
Claim 9
Dependent Claim 27 words
A probe as claimed in claim 1, wherein the control system is configured to energize the electrode surface segments after the cooling system precools the intermediate tissue.
Claim 10
Dependent Claim 23 words
A probe as claimed in claim 8, wherein the control system is adapted to effect a regimen of timed pre-cooling and then heating.
Claim 11
Independent Claim 115 words
A method for therapeutically heating a target zone of a collagenous support tissue within a female patient body, the method comprising: engaging a probe against the tissue, the probe having a plurality of electrode surface segments; cooling the tissue adjacent the probe with the electrode surface segments; and directing an electrical current flux from the electrode surface segments, through the cooled tissue, and into the target zone by selectively energizing the electrode surface segments so that the current flux substantially evenly heats the target zone without ablating the collagenous support tissue, and so that the collagenous support tissue inhibits incontinence, wherein the cooling step inhibits necrosis of the copied tissue during the flux directing step.
Claim 12
Independent Claim 115 words
A method for therapeutically heating a target zone of a collagenous support tissue within a female patient body, the method comprising: engaging a probe against the tissue, the probe having a plurality of electrode surface segments; cooling the tissue adjacent the probe with the electrode surface segments; and directing an electrical current flux from the electrode surface segments, through the cooled tissue, and into the target zone by selectively energizing the electrode surface segments so that the current flux substantially evenly heats the target zone without ablating the collagenous support tissue, and so that the collagenous support tissue inhibits incontinence, wherein the cooling step inhibits necrosis of the copied tissue during the flux directing step.
Claim 13
Dependent Claim 30 words
A method as claimed in claim 10, wherein the flux directing step comprises applying varying electrical potentials to the surface segments, the surface segments defining a substantially flat electrode surface.
Claim 14
Dependent Claim 40 words
A method as claimed in claim 10, further comprising monitoring a temperature of the cooled tissue, the target zone separated from the probe by a cooled tissue depth, and limiting the current flux in response to the monitored tissue temperature.
Claim 15
Dependent Claim 77 words
A method as claimed in claim 10, wherein the directing energy step comprises applying a bipolar electrical potential between two of the electrode surface segments, the electrode surface segments disposed along a tissue engaging surface of the probe, the cooling step comprising cooling a portion of the tissue engaging surface disposed between the electrode surface segments so that the target zone is separated from the tissue engaging surface by the cooled tissue between the electrode surface segments.
Claim 16
Dependent Claim 21 words
A method as claimed in claim 13, further comprising controlling a depth of heating using a spacing between the bipolar electrodes.
Claim 17
Dependent Claim 37 words
A method as claimed in claim 10, wherein the cooling step comprises precooling an intermediate tissue engaged by the probe before the current directing step, the intermediate tissue disposed between the probe and the collagenous support tissue.
Claim 18
Dependent Claim 21 words
A method as claimed in claim 15, wherein the cooling step further comprises precooling the intermediate tissue for a predetermined time.
Claim 19
Dependent Claim 158 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, the control system selectively energizing the segments in response to a depth of the intermediate tissue between the electrode and the target tissue, the energized segments having a smaller area than a total segment area to reduce heating depth in correlation with the intermediate tissue depth.
Claim 20
Dependent Claim 158 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, the control system selectively energizing the segments in response to a depth of the intermediate tissue between the electrode and the target tissue, the energized segments having a smaller area than a total segment area to reduce heating depth in correlation with the intermediate tissue depth.
Claim 21
Dependent Claim 176 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the target tissue comprising a fascial sheet, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue, the electrode surface segments disposed along a tissue engaging surface of the probe and the target tissue defining a significant misalignment angle with the tissue engaging surface; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, the control system selectively varying an electrical current and heat time from the electrode surface segments in response to the misalignment angle so as to evenly heat the fascial sheet.
Claim 22
Dependent Claim 176 words
A probe for heating a target tissue of a patient body through an intermediate tissue, the target tissue comprising a fascial sheet, the probe comprising: a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue, the electrode surface segments disposed along a tissue engaging surface of the probe and the target tissue defining a significant misalignment angle with the tissue engaging surface; a cooling system coupled to the probe for cooling the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, the control system selectively varying an electrical current and heat time from the electrode surface segments in response to the misalignment angle so as to evenly heat the fascial sheet.
Claim 23
Dependent Claim 210 words
A probe for heating a target tissue of a patient body through a predetermined intermediate tissue, the probe comprising: a probe body supporting a plurality of bipolar electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue; a cooling system coupled to the probe for cooling the electrode surface segments, wherein the cooling system cools the engaged intermediate tissue disposed between the electrode surface segments, the intermediate tissue separating the probe from the target tissue between the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, wherein the control system can apply a bipolar electrical potential between electrode surface segments, and wherein the electrode surface segments are adapted to direct a current flux through the engaged intermediate tissue and into the target tissue, the electrode surface segments separated by a spacing determined by a depth of the predetermined intermediate tissue, the electrode spacing controlling a depth of heating of the bipolar energy.
Claim 24
Dependent Claim 210 words
A probe for heating a target tissue of a patient body through a predetermined intermediate tissue, the probe comprising: a probe body supporting a plurality of bipolar electrode surface segments, the electrode surface segments simultaneously engagable against the intermediate tissue; a cooling system coupled to the probe for cooling the electrode surface segments, wherein the cooling system cools the engaged intermediate tissue disposed between the electrode surface segments, the intermediate tissue separating the probe from the target tissue between the electrode surface segments; and a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature without ablating the target tissue while the cooling system maintains the intermediate tissue disposed between the electrode surface segments and the target tissue below a maximum safe tissue temperature, wherein the control system can apply a bipolar electrical potential between electrode surface segments, and wherein the electrode surface segments are adapted to direct a current flux through the engaged intermediate tissue and into the target tissue, the electrode surface segments separated by a spacing determined by a depth of the predetermined intermediate tissue, the electrode spacing controlling a depth of heating of the bipolar energy.
Claim 25
Dependent Claim 36 words
A probe as claimed in claim 19, wherein the probe has a size and configuration suitable for transvaginal insertion, and wherein the electrode spacing is suitable for heating the collagenous support tissue through a vaginal wall.
Claim 26
Dependent Claim 34 words
A probe as claimed in claim 20, wherein the control system is adapted to effect shrinkage of endopelvic fascia without ablating the endopelvic fascia while the cooling system inhibits necrosis of the vaginal wall.
Claim 27
Dependent Claim 22 words
A probe as claimed in claim 19, wherein the controller is adapted to effect a predetermined regimen of precooling and then heating.
Claim 28
Independent Claim 129 words
A method for therapeutically heating a target zone of a collagenous support tissue within a patient body, the method comprising: inserting a probe transvaginally; engaging the probe against the tissue, the probe having a plurality of electrode surface segments; cooling the tissue adjacent the probe with the electrode surface segments, wherein the cooled tissue comprises a vaginal wall; and directing an electrical current flux from the electrode surface segments, through the cooled tissue, and into the target zone by selectively energizing the electrode surface segments so that the current flux substantially evenly heats the target zone without ablating the collagenous support tissue, wherein the cooling step inhibits necrosis of the cooled tissue during the flux directing step, and wherein the current flux directing step heats the collagenous support tissue.
Claim 29
Independent Claim 129 words
A method for therapeutically heating a target zone of a collagenous support tissue within a patient body, the method comprising: inserting a probe transvaginally; engaging the probe against the tissue, the probe having a plurality of electrode surface segments; cooling the tissue adjacent the probe with the electrode surface segments, wherein the cooled tissue comprises a vaginal wall; and directing an electrical current flux from the electrode surface segments, through the cooled tissue, and into the target zone by selectively energizing the electrode surface segments so that the current flux substantially evenly heats the target zone without ablating the collagenous support tissue, wherein the cooling step inhibits necrosis of the cooled tissue during the flux directing step, and wherein the current flux directing step heats the collagenous support tissue.
Claim 30
Dependent Claim 47 words
A method as claimed in claim 23, wherein the collagenous support tissue comprises endopelvic fascia, wherein the cooling step inhibits necrosis of the vaginal wall, and wherein the flux directing step effects shrinkage of the endopelvic fascia without ablating the endopelvic fascia so as to inhibit incontinence.
Claim 31
Dependent Claim 17 words
A method as claimed in claim 22, wherein the flux directing step shrinks the collagenous support tissue.
Claim 32
Dependent Claim 43 words
A method as claimed in claim 25, wherein the flux directing step heats the collagenous tissue to a treatment temperature in a range from about 60 C to about 110 C while the cooling step maintains the cooled tissue below about 45 C.
Claim 33
Dependent Claim 33 words
A method as claimed in claim 26, wherein the flux directing step heats the collagenous tissue to the treatment temperature for a time in a range from about 10 seconds to 2 minutes.

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