WO2000006035A1 - Dispositifs de transfert de chaleur limite et procedes pour contracter des tissus - Google Patents

Dispositifs de transfert de chaleur limite et procedes pour contracter des tissus Download PDF

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Publication number
WO2000006035A1
WO2000006035A1 PCT/US1999/016548 US9916548W WO0006035A1 WO 2000006035 A1 WO2000006035 A1 WO 2000006035A1 US 9916548 W US9916548 W US 9916548W WO 0006035 A1 WO0006035 A1 WO 0006035A1
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WIPO (PCT)
Prior art keywords
tissue
probe
ofthe
electrodes
energy
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Application number
PCT/US1999/016548
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English (en)
Inventor
Frank W. Ingle
Original Assignee
Surx, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/170,940 external-priority patent/US6067270A/en
Application filed by Surx, Inc. filed Critical Surx, Inc.
Priority to AU52216/99A priority Critical patent/AU5221699A/en
Publication of WO2000006035A1 publication Critical patent/WO2000006035A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B2018/1246—Generators therefor characterised by the output polarity
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
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    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter

Definitions

  • the present invention generally relates to medical devices, methods and systems for selectively contracting tissues, particularly for the treatment of urinary incontinence.
  • Urinary incontinence arises in both men and women with varying degrees of severity, and from different causes.
  • men the condition most frequently occurs as a result of prostatectomies which result in mechanical damage to the urethral sphincter.
  • women the condition typically arises after pregnancy when musculoskeletal damage has occurred as a result of inelastic stretching of the structures which support the genitourinary tract. Specifically, pregnancy can result in inelastic stretching ofthe pelvic floor, the external sphincter, and the tissue structures which support the bladder and bladder neck region.
  • sutures, straps or other artificial structures are often looped around the bladder neck and affixed to the pelvis, the endopelvic fascia, the ligaments which support the bladder, or the like.
  • Other procedures involve surgical injections of bulking agents, inflatable balloons, or other elements to mechanically support the bladder neck.
  • An alternative surgical procedure which is performed to enhance support ofthe bladder is the Kelly plication. This involves midline plication ofthe fascia, particularly for repair of central defects. In this transvaginal procedure, the endopelvic fascia from either side ofthe urethra is approximated and attached together using silk or linen suture.
  • Each of these known procedures has associated shortcomings. Surgical operations which involve midline plications or direct suturing ofthe tissues ofthe urethra or bladder neck region require great skill and care to achieve the proper level of artificial support. In other words, it is necessary to occlude or support the tissue sufficiently to inhibit urinary leakage, but not so much that intentional voiding is made difficult or impossible. Balloons and other bulking agents which have been inserted can migrate or be absorbed by the body. The presence of such foreign body inserts can also be a source of urinary tract infections.
  • the present invention provides improved devices, methods, and systems for repeatably and reliably contracting fascia and other support tissues, particularly for the treatment of urinary incontinence.
  • the techniques ofthe present invention generally enhance the support provided by the natural tissues ofthe pelvic floor. Rather than relying entirely on the surgeon's ability to observe, direct, and manually control the selective shrinking of these tissues, the present invention makes use of tissue contraction systems which limit tissue heating automatically.
  • a probe ofthe system is placed statically against the target tissue. In other embodiments, the probe moves across the tissue, often with a slow rolling contact.
  • the tissue contraction system will limit tissue heating to avoid ablating the target tissue and to limit collateral tissue damage, the system preferably directing only sufficient energy into the tissue so as to shrink the target tissue, with the shrinkage ideally being delivered to a pelvic supported tissue so as to inhibit incontinence.
  • the invention provides a probe for contracting a target tissue of a patient body.
  • the probe comprises a probe body having a tissue engaging surface, and an energy transmitting element disposed along the surface ofthe probe.
  • the energy transmitting element is capable of directing sufficient energy into the target tissue to shrink the target tissue.
  • the energy transmitting element also includes a mechanism that limits transmitted energy so as to avoid injury to the target tissue. Suitable energy limiting mechanisms include a predetermined thermal mass, a limited quantity of a reaction mass, and the like.
  • the invention provides a system for treating a target tissue of a patient body.
  • the target tissue has a tissue surface
  • the system comprises a probe body defining proximal orientation and a distal orientation.
  • a rolling member is rotatably mounted to the probe body.
  • a plurality of electrodes are mounted on the rolling member.
  • An electrical power source is coupled to the electrodes so as to drive a bipolar electrical current between the electrodes.
  • the invention provides a tissue contraction system for shrinking a tissue having a tissue surface.
  • This system comprises a probe having a thermally conductive body.
  • a control unit is electrically coupled to the body. The control unit applies electrical energy to the body so as to heat the body before the body engages the tissue surface. The control unit limits the electrical energy so that the probe heats the tissue to a temperature within a tissue contraction temperature range.
  • the present invention also provides a method for treating tissue.
  • the tissue has a tissue surface, and the method comprises rolling a member against the tissue surface so that electrodes mounted on the member engage the tissue.
  • a bipolar current is driven between the engaging electrodes and through the tissue.
  • Fig. 1 is a lateral cross-sectional view showing the urinary bladder and a bladder support structure.
  • Fig. 2 is a cross-sectional view of a patient suffering from urinary stress incontinence due to inelastic stretching ofthe endopelvic fascia.
  • Fig. 3 shows a known method for treating urinary incontinence by affixing sutures around the bladder neck.
  • Fig. 4 illustrates improved bladder support provided by contracting the endopelvic fascia according to the principles ofthe present invention.
  • Fig. 5 is a perspective view of a probe having a thin flat credit card shaped body and a treatment surface with a two-dimensional array of bi-polar electrode pairs.
  • Fig. 5 A is a front view ofthe probe of Fig. 5.
  • Figs. 5B and C are side and front views, respectively, of a probe having an electrode array supported by a shaft.
  • Figs. 5D-G illustrate the structure and electrical layout ofthe electrode array for the probe of Figs. 5A and B.
  • Figs. 6A-C are schematic block diagram showings of a static tissue contraction system having an electrode array with optional temperature feedback signals.
  • Figs. 7A-E schematically illustrate methods for accessing left and right target regions ofthe endopelvic fascia.
  • Fig. 8 is a cross-sectional view showing a method for treating a left target region ofthe endopelvic fascia.
  • Figs. 9A-D schematically illustrate a picture frame shaped tissue contraction device having an independently energizeable peripheral portion so as to treat tissue surrounding an initially contracted region.
  • Figs. 10A and B illustrate an alternative probe having a two-dimensional electrode array.
  • Figs. 11 A and B illustrate a probe structure having a two-dimensional array of posts for independently engaging, heating and contracting tissue, in which the posts may optionally include resistive heaters and temperature sensors.
  • Fig. 12 is a cross-sectional view of a probe structure having heat transfer surfaces thermally coupled to diodes and to the target tissue so as to allow the diodes to act as both heaters and temperature sensors.
  • Fig. 12A is a drive/feedback block diagram for the probe of Fig. 12.
  • Fig. 13 illustrates an alternative probe structure in which a conduit directs a heated fluid along a treatment surface ofthe probe.
  • Fig. 14 illustrates a still further alternative probe in which a plurality of irrigation ports are disposed between a one-dimensional array of elongate electrodes.
  • Fig. 15 illustrates a semi-rigid probe body which flexes to help ensure the treatment surface ofthe probe is in contact with the target tissue.
  • Fig. 16 illustrates a probe having a cavity that receives the urethra to help ensure that the treatment surface is separated from the urethra by a protection zone.
  • Figs. 17A-C illustrate front and side views of a probe having a balloon which urges the treatment surface ofthe probe against the target tissue.
  • Figs. 18A-C illustrate a minimally invasive probe having interspersed heating and cooling areas to effect tissue contraction with minimal damage to the target tissue, and in which the probe includes a balloon that can be inserted to a treatment site in a narrow configuration and expanded at the treatment site to engage and treat the full target region without moving the probe.
  • Figs. 19A-C illustrate a probe having interspersed hot and cold posts.
  • Fig. 20 is a cross-sectional view showing a probe having a heating element with a limited quantity of a reaction material such that the total heat energy that will be transmitted to the target tissue is limited.
  • Fig. 21 illustrates a tissue contracting kit including the probe of Fig. 5 and instructions for its use.
  • Fig. 22 illustrates a bipolar probe having a series of electrodes mounted to a rolling member, and a method for its use by transmitting bipolar energy between a pair ofthe electrodes while the pair engage a tissue surface ofthe target tissue.
  • Fig. 23 illustrates a probe similar of that of Fig. 22, in which the electrodes have axially elongate tissue engaging surfaces.
  • Fig. 24 schematically illustrates a "branding iron" probe having a thermal mass which can be pre-heated using resistive heating before engaging the tissue surface, together with a simple control unit for limiting the heat energy thermally conducted form the probe to the tissue.
  • the present invention generally provides methods, devices, and systems which repeatably contract tissue, particularly as a therapy for incontinence.
  • the techniques ofthe invention will often involve positioning a probe so that a surface of the probe engages a target tissue statically, that is, without relative movement between the probe and the engaged tissue surface during treatment. Energy will then be transmitted from the treatment surface ofthe probe into the target tissue so as to effect the desired contraction. This allows the contraction to be controlled by the configuration and/or software ofthe system, rather than relying on a surgeon's experience to allow him or her to "paint" a small area electrode surface across a sufficient portion ofthe target region at a proper rate to effect contraction without imposing excessive injury on the target tissue.
  • the probe will move across the target tissue (often with a rolling motion) while limiting the heating ofthe engaged tissue.
  • these techniques will be effective for controllably and repeatably contracting a wide variety of fascia and other collagenated tissues throughout the body, they will find applications in a wide variety of therapies, including skin wrinkle shrinkage, tightening stretched tendons and ligaments in knees, ankles, and wrists, treatment of droopy eyelids, shrinking large earlobes, and the like.
  • the most immediate application for the invention will be to enhance the patient's own natural support ofthe bladder, bladder neck region, and urethra so as to inhibit urinary incontinence.
  • the techniques ofthe present invention will often be used to contract fascia, tendons, and other collagenous tissues, preferably without ablation of these collagenous tissues.
  • Collagenous tissues may occasionally be referred to herein as collagenated tissues.
  • endopelvic fascia EF defines a hammock-like structure which extends laterally between the left and right arcus tendinous fascia pelvis ATFP. These later structures extend substantially between the anterior and posterior portions ofthe pelvis, so that the endopelvic fascia EF largely defines the pelvic floor.
  • the fascial tissue ofthe pelvic floor may comprise tissues referred to under different names by surgeons of different disciplines, and possibly even by different practitioners within a specialty.
  • the collagenous support structure referred to herein as the endopelvic fascia one name when viewed from a superior approach, and a different name when viewed from an inferior approach.
  • Some or all of this support structure may comprise two collagenous layers with a thin muscular layer therebetween, or may comprise a single collagenous layer.
  • the therapy ofthe present invention may be directed toward any ofthe collagenous portions ofthe support structures for the urethra, bladder neck, and bladder.
  • the treated tissues may include and/or be referred to as endopelvic fascia, arcus tendinous fascia ⁇ pelvis, urethropelvic ligaments, periurethral fascia, levator fascia, vesicopelvic fascia, transversalis fascia, and/or vesicle fascia, as well as other collagenous support structures.
  • the bladder In women with urinary stress incontinence due to bladder neck hypermobility, the bladder has typically dropped between about 1.0 cm and 1.5 cm (or more) below its nominal position. This condition is typically due to weakening and/or stretching ofthe pelvic support tissues, including the endopelvic fascia, the arcus tendinous fascia pelvis, and the surrounding ligaments and muscles, often as a result of bearing children.
  • the present invention generally provides a therapy which effectively reduces the length ofthe pelvic support tissues and returns bladder B towards its nominal position.
  • the bladder is still supported by the fascia, muscles, ligaments, and tendons ofthe natural pelvic support tissues.
  • bladder B can be seen to have dropped from its nominal position (shown in phantom by outline 10). While endopelvic fascia EF still supports bladder B to maintain continence when the patient is at rest, a momentary pressure pulse P opens the bladder neck N resulting in a release of urine through urethra UR.
  • a known treatment for urinary stress incontinence relies on suture S to hold bladder neck N closed so as to prevent inadvertent voiding, as seen in Fig. 3.
  • Suture S may be attached to bone anchors affixed to the pubic bone, ligaments higher in the pelvic region, or the like. In any case, loose sutures provide insufficient support of bladder neck N and fail to overcome urinary stress incontinence. Over tightening suture S may make normal urination difficult and/or impossible.
  • bladder B may be elevated from its lowered position (shown by lowered outline 12).
  • contraction of selected tissues may reduce or eliminate slack in the support structures without raising the bladder, and/or may reduce the elongation of the support structures to reduce dropping ofthe bladder when under stress.
  • a pressure pulse P will then be resisted in part by endopelvic fascia EF which supports the lower portion ofthe bladder, helping maintain the bladder neck in a closed configuration.
  • Fine tuning ofthe support provided by the endopelvic fascia is possible through selective modification ofthe anterior portion ofthe endopelvic fascia.
  • To close the bladder neck and raise bladder B upward for example, it may be possible to effect a greater total tissue contraction towards the front.
  • repositioning of bladder B to a more forward position may be affected by selectively contracting the dorsal portion ofthe endopelvic fascia EF to a greater extent then the forward portion.
  • the therapy ofthe present invention may be tailored to the particular weakening exhibited by a patient's pelvic support structures. Regardless, the portion ofthe endopelvic fascia EF adjacent the bladder neck and urethra UR can remain free of sutures or other artificial support structures which might directly compress the urethra.
  • a credit card shaped probe 20 includes a thin flat probe body 22 having a treatment surface 24.
  • a two-dimensional array of electrodes 26 is distributed across treatment surface 24, the electrodes here being arranged in bipolar pairs.
  • treatment surface 24 of probe 20 has a length 29 and a width 30 that are significantly greater than a thickness of probe body 22.
  • Length 24 will typically be at least about 10 mm, while width 30 will generally be at least about 5 mm.
  • length 28 will be between about 10 and 50 mm, with width 30 being between about 5 and 30 mm.
  • Probe body 22 will usually have a thickness of between about 1 and 15 mm. In many embodiments, the thickness of probe body 22 will be about 8 mm or less, typically being from about 8 mm to about 1 mm, and preferably being about 5 mm or less.
  • the probe body will often be at least semi-rigid. In other words, although probe body 22 may flex, the probe body will generally have a stiffness greater than that of fascial tissue. This helps ensure that each of electrodes 26 can be effectively coupled to the fascial tissue surface by urging an interior portion ofthe probe body against the target tissue. Body 22 may flex slightly during such pressure so that both surfaces conform somewhat to each other. Body 22 may be substantially rigid so that the fascial surface conforms substantially entirely to the shape of probe 20.
  • the probe body may comprise a polymer such as polycarbonate, ABS plastic, or the like.
  • the tissue temperature can be controlled in a variety of ways so as to limit variability in efficacy. Feedback to a computer which controls power to electrodes 26 might directly indicate temperature, or the computer might instead control the treatment time. Signals might be provided to the computer indicating the electrical power being used, the electrical energy which has been input to the tissue, or the impedance ofthe tissue as measured by the current and voltage ofthe RF energy deliver to the probe. Additionally, the spacing between created and non- treated regions may be set by the structure ofthe probe and array, and/or by selectively energizing the electrodes ofthe probe. This further controls the therapy to eliminate or reduce user variability.
  • Electrodes 26 may be substantially flush with tissue treatment surface 24, or may alternatively protrude from the tissue treatment surface. When protruding electrodes are used, they will often present a rounded surface for engagement against the fascial tissue so as to minimize the concentration of electrical current density (as might otherwise occur at sharp corners). As is explained in more detail in U.S. Patent Application No. 08/910,370, filed August 13, 1997, the full disclosure of which is incorporated herein by reference, the depth of tissue treatment may be varied when using bi-polar electrodes by setting the spacing 32 between a pair of electrodes 34, and/or by setting a diameter or radius of curvature of electrodes 26 where they engage the tissue surface.
  • the electrodes have a radius of curvature of 0.012 inches, are formed of stainless steel, and are separated by about six times the radius of curvature (between their inner edges) to limit heating depth to less than about 3 mm.
  • the spacing between electrode pairs should allow treatment of a relatively large amount of fascia without damage to the urethra. Spacing between pairs may also leave some untreated tissue interspersed between the treated regions, which will promote healing.
  • the interspersed untreated areas ofthe target tissue may comprise fascia and/or other collagenous tissues, and the pairs may be separated such that at least a portion ofthe untreated tissue can remain at or below a maximum safe tissue temperature throughout treatment, optionally remaining below 60° C, and in some embodiments remaining below 45° C.
  • a fascial tissue can be safely heated to a contraction temperature by transmitting a current between a pair of electrodes having a radius of curvature at the tissue interface in a range from about 0.05 to about 2.0 mm, ideally being about 0.3 mm, where the electrodes are separated by a distance in the range from about 1 to about 10 times the radius of curvature ofthe electrodes.
  • the driving energy may be applied using an intermittent duty cycle to effect the desired increase in temperature.
  • the tissue will be heated to a safe contraction temperature in a range from about 70° C to about 140° C for a time in the range from about 0.5 to about 40 sees, typically for a time from about 0.5 to about 10 sees.
  • probe body 22 is supported by a rigid shaft 23 extending from a handle 25.
  • Shaft 23 may be bent to orient treatment surface 24 to engage the endopelvic fascia.
  • a flex joint 27 may be provided at the junction of shaft 23 and probe body 22 to help ensure that the entire treatment surface 24 engages the fascial surface when the treatment surface is held in position manually from handle 25.
  • Joint 27 may comprise a pliable or resilient structure and/or material adjacent the shaft/body interface, such as an elastomer, a polymer, a ball and socket arrangement, a pair of orthogonal pivots, or the like.
  • Shaft 23 may comprise a stainless steel hypotube containing the conductors coupled to electrodes 26, or any of a variety of alternative metal, polymer, or composite structures.
  • the handle will often comprise a polymer such as polycarbonate, ABS plastic, or the like, and may optionally include controls for energizing the electrodes.
  • the configuration ofthe electrode array is generally fixed by the probe body structure. This often sets the tissue heating pattern (based on the electrode size and spacing between electrode pairs), as the probe body will be held at a fixed position against the tissue during tissue heating. This predetermined heating pattern helps avoid over-treatment of some tissues and under contraction of others, as can occur when manually painting a small treatment surface repeatedly across the target tissue.
  • the shape and layout ofthe electrodes can provide preferential contraction ofthe target tissue along a desired orientation.
  • the engaged tissue can be contracted to a significantly greater extent in width (across the electrode pairs) than in length (along the electrodes).
  • any pattern of elongate heated tissue zones (such as between an elongate pair of electrodes) may provide preferential contraction across the elongate heat zones as compared to along their length, particularly when such elongate heat zones are alternated with elongate untreated zones (such as between the pairs). This can be extremely useful when a surgeon wants to, for example, decrease a lateral width ofthe endopelvic fascia while minimizing the reduction in its anterior/posterior length.
  • Probe body 22 will often be formed as a multilayer structure to facilitate electrically coupling conductors 28 to electrodes 26. As shown in Fig. 5, for monopolar operation, only a single conductor need be electrically coupled to the electrodes, while a separate conductor can be coupled to a large return electrode placed on the leg or back of the patient. Bipolar operation will generally include at least two- conductors, while both monopolar and bipolar probes will often include larger numbers of conductors to selectively vary the electrical power across treatment surface 24.
  • Electrodes 26 are formed from wires of stainless steel, copper, or the like, but may alternatively comprise plates oriented perpendicularly to the treatment surface, the plates having rounded or radiused edges, with only the edges exposed. Electrodes 26 are coupled to the power supply with wires or other conductors disposed between a main probe body 22a and a back insulating layer 22b.
  • the conductors extend proximally through hypotube 23, which may also include a lumen for delivering a conduction enhancing liquid or gel, typically for delivery of about 1 cc/min of saline through one or more weep holes in treatment surface 24 adjacent or between the pairs of electrodes (as can be understood with reference to Fig. 14).
  • Probe body 22 will typically be rigid in this embodiment, often being formed of a polymer such as ABS plastic, polycarbonate, or the like, but may alternatively be semi-rigid (typically comprising silicone or nylon).
  • Probe 20 may optionally include a variety of mechanisms to actively control contraction ofthe target tissue.
  • body 22 may include multiplexing circuitry which selectively directs electrical energy supplied through a limited number of conductors to the electrodes or electrode pairs. Such circuitry will optionally vary the electrical energy or duty cycle ofthe electrodes depending on temperatures measured at or near the electrodes. Alternatively, a uniform heating energy may be directed from treatment surface 24 based on one or more temperature measurements, based on dosimetry, or the like. Circuitry for probe 20 may incorporate microprocessors or the like. Alternatively, signals may be transmitted from the probe to an external processor for control ofthe contraction energy.
  • Exemplary probe circuits are illustrated in Figs. 5F and G.
  • the coupling arrangement illustrated in Fig. 5F allows an M x N array of electrode pairs to be selectably energized using only M+N conductors.
  • This arrangement takes advantage of the fact that current (and heating) will be concentrated along the path of least electrical resistance, which will generally be between the two closest bipolar electrodes.
  • rows of electrodes are coupled together and columns of electrodes are coupled together so that a particular electrode pair 1, 2, 3, ...6 is selected by driving a current between the associated column and the associated row.
  • electrode pair 3 is selected by driving bipolar current between the electrodes of column 1 and the electrodes of row 2.
  • Current (and heating) between energized electrodes other than pair 3 will not be sufficient to significantly contract tissue.
  • the electrode pairs are energized by heating each pair associated with a column starting with the middle pair (for example, pair 3, then pair 1, then pair 5), and then moving on to the next column (for example, pair 4, pair 2, and then pair 6).
  • Temperature sensors 31 may comprise thermistors, thermocouples, or the like, and will be mounted to probe body 22 so as to engage the tissue between a pair of electrodes to limit the number of signal wires, temperature sensors 31 are coupled to a multiplexer MUX mounted in handle 25, or possibly in probe body 22. As such temperature sensors provide temperature signals which are repeatable (for each mounted sensor) though not necessarily predictable, the accuracy ofthe temperature feedback can be enhanced by storing calibration data for this probe, and ideally for each temperature sensor, in a non-volatile memory such as an EEPROM.
  • a non-volatile memory such as an EEPROM.
  • Static contraction systems including probe 20 are shown schematically in Figs. 6A-C.
  • power from an electrical power source 33 is directed to the electrodes of probe 20' by a switching unit 35 under the direction of a processor 37.
  • the temperature may be controlled by selectively energizing and halting power to the probe (sometimes called a bang-bang feedback control) to maintain the desired temperature or temperature profile, or the controller and/or switching unit may selectively vary the power level.
  • the total desired shrinkage of a discrete target region of endopelvic fascia EF may be controlled without moving probe 20.
  • Total contraction of the endopelvic fascia will depend on a number of factors. Generally, tissue will contract locally by up to 70% (areal shrinkage) when heated to a contraction temperature range. Therefore, it is possible to select a probe 20 having a treatment surface 24 with a size and shape suitable for providing a total effective contraction of endopelvic fascia EF so as to provide the desired improvement in support ofthe pelvic floor. It may therefore be desirable to provide a series of differing probes for contracting tissues by differing amounts.
  • a probe having a lateral dimension of 12 mm may be selected to decrease an effective lateral dimension of the right portion ofthe endopelvic fascia by 5 mm.
  • a greater amount of contraction might be effected by selecting an alternate probe with a greater width.
  • Selecting probes having differing lengths, selecting among alternative probes having treatment surfaces 24 which are wider at one end than the other, or selectively positioning the probe along the midline might allow the surgeon to tailor the enhanced support to lift the anterior or posterior portions ofthe bladder to a greater or lesser degree, as desired.
  • Still further alternative contraction control mechanisms might be used.
  • the surgeon may heat the tissue to a lower temperature, and/or may selectively heat only a portion ofthe tissue which engages treatment surface 24 (for example, by energizing only a selected subset of electrodes 26). Electrical properties ofthe system can be monitored before, during, between, and/or after energizing the probe with tissue heating current. For example, as the controller selectively energizes the electrode pairs, the system impedance can be monitored to help ensure that sufficient electrode/tissue coupling is maintained for the desired treatment. In a simple feedback indication arrangement, a warning light may illuminate to inform the surgeon that coupling was (or is) insufficient.
  • More sophisticated feedback systems may re-treat selected undertreated areas by re-energizing electrode pairs for which coupling was compromised.
  • these feedback systems generate a feedback signal FS to indicate an effect ofthe treatment on the tissue, as schematically illustrated in Fig. 6A.
  • Feedback signal FS may simply provide an indication to the surgeon, or may be processed by the controller to modify the treatment. Regardless, this controlled contraction can be provided without moving probe 20.
  • endopelvic fascia EF can be viewed as left and right fascial portions separated at the patient's midline by urethra UR. Endopelvic fascia EF is supported by ligaments ATFP above a vaginal wall VW. It may be desirable to selectively shrink endopelvic fascia EF along target regions 40 which extend in an anterior posterior direction along the left and right sides ofthe endopelvic fascia. This should provide enhanced support of urethra UR, the bladder neck, and the bladder with little risk of heating, denervating or injuring the delicate urethral tissues.
  • a weighted speculum 42 is inserted into the vagina to expose the anterior vaginal wall VW.
  • elongated laterally offset incisions 43 might be made in the anterior vaginal wall so that the vaginal mucosa could be manually dissected to reveal the endopelvic fascia EF.
  • a small incision 44 may be made on either side of urethra UR, thereby allowing access for a minimally invasive blunt dissection device 46.
  • Dissection device 46 includes a mechanical expansion element in the form of a balloon 48 at its distal end.
  • Balloon 48 dissects the back side ofthe vaginal wall from the endopelvic fascia to create a minimally invasive treatment site 50 along each ofthe discrete target regions 40, as seen in Fig. 7D.
  • the exposed endopelvic fascia will preferably be irrigated with saline or the like to reduce fouling ofthe electrodes, and to enhance electrode/tissue coupling with a conductive film.
  • the patient will preferably be positioned so that excess irrigation fluid drains from the tissue surface, and aspiration will often be provided to clear any drained fluids.
  • FIG. 7E An alternative method for accessing the endopelvic fascia is illustrated in Fig. 7E.
  • This is sometimes referred to as the Raz technique, and generally comprises separating an arch-shaped mid-line flap F from the surrounding vaginal wall VW to access the underlying and adjacent endopelvic fascia as shown. This procedure was described in more detail by Shlomo Raz in Female Urology, 2nd. Ed. (1996) on pages 395-397.
  • probe 20 is inserted through incisions 43 or 44 to treatment site 50.
  • Treatment surface 24 is urged against exposed surface 52 of endopelvic fascia EF so that electrodes 26 are effectively coupled with the endopelvic fascia.
  • Probe 20 may be biased against the endopelvic fascia manually by pressing against the wall of vaginal mucosa VM, by pressing directly against the probe using a finger inserted through incision 43 or 44, or using a shaft attached to the probe that extends proximally through the incision.
  • probe 20 may include a mechanical expansion mechanism for urging treatment surface 24 against the endopelvic fascia EF.
  • Electrodes 26 are energized via conductors 28 (see Fig. 5). Electrodes 26 direct electrical current through the endopelvic fascia so that the resistance ofthe fascia causes an increase in tissue temperature.
  • the use of relatively large electrode surfaces having a sufficiently large radius of curvature avoids excessive concentration of electrical current density near the tissue/electrode interface which might cause charring, tissue ablation, or excessive injury to the tissue.
  • probe 20 does not move during this contraction, it should be noted that at least a portion of endopelvic fascia EF may slide along treatment surface 24, since the tissue contracts while the probe generally does not.
  • Fig. 9A schematically illustrates a treatment surface 24 having a peripheral "picture frame" portion 56 which can be energized independently of an interior portion 54.
  • tissue 58 engaging treatment surface 24 contracts inward as shown in Fig. 9B.
  • peripheral portion 56 can be energized independently of the interior portion so that the uncontracted tissue 60 that now engages treatment surface 24 can be safely contracted.
  • electrodes 62 may optionally comprise monopolar or bipolar rounded buttons or flat disks defining a two-dimensional array.
  • a temperature sensor may be provided for each button. For bipolar heating, radiofrequency current may be driven from one button electrode to another. Alternatively, radiofrequency current may be driven from each button to a large surface area pad applied against the patient's back in a monopolar configuration.
  • radiofrequency current When used in a bipolar mode, it may be desirable to drive radiofrequency current between pairs of electrodes that are separated by at least one other electrode. This may allow heating to a more even depth, as heating energy will be concentrated near the engaged tissue surface adjacent each electrode, but will be distributed to a greater depth midway between the electrodes of a bipolar pair. For example, it is possible to drive radiofrequency current from electrode 62a to electrode 62c, from electrode 62b to electrode 62d, from electrode 62e to electrode 62g, from electrode 62f to electrode 62h, and the like.
  • N X M electrode array it is possible to independently drive each of these electrode pairs using only N+M conductors between the driving power source and the electrodes, as described above regarding Fig. 5F.
  • buttons electrodes of Figs. 10A and B may be mounted on an inflatable balloon which could be rolled up into a narrow configuration for insertion to the treatment site. The balloon could then be inflated to allow engagement of the treatment surface against the target tissue.
  • a two-dimensional array of protrusions 64 each include a resistive heater 66 and a temperature sensor 68.
  • the ends of protrusions 64 can safely include corners without concentrating heat.
  • the protrusions can have heat transfer ends that are round, square, hexagonal, or the like, and the protrusions can be cylindrical, conical, or some other desired shape.
  • flush heat transfer surfaces may be formed with similar structures.
  • the protrusions 64 can be pressed against the tissue surface and resistive heaters 66 can be energized while active temperature feedback is provided by temperature sensor 68.
  • This feedback can be used to heat the protrusions to the desired treatment temperature for a predetermined time so as to effect the desired tissue contraction.
  • the temperature sensors may measure the actual temperature ofthe tissue, rather than that ofthe protrusion.
  • a two-dimensional array of heat transfer surfaces 70 might make use of thermally conductive materials that extend from or are flush with treatment surface 24.
  • At least one electrical component 72 is thermally coupled to an associated heat transfer surface 70 so that the component varies in temperature with the temperature ofthe surface.
  • the component will typically have an electrical characteristic which varies with temperature, the component typically comprising a transistor, thermistor, or silicon diode.
  • Component 72 can be coupled to conductor 28 using a printed circuit board 74.
  • the tissue engaging heat transfer surface 24 is heated by passive conduction from heat transfer surfaces 70.
  • the heating electrical current is applied as intermittent pulses. Between heating pulses, a small constant current can be driven through a diode in a forward direction, and the voltage across the junction can be measured using printed circuit board 74.
  • the forward voltage across this junction is often dependent on the temperature of the junction, typically varying by about 2 mV/°C for a silicon diode. This forward voltage can be used to measure the junction temperature.
  • the timing ofthe heating pulses and the structure of heat transfer surface 70 can be set so that the diode junction will indicate the temperature ofthe tissue against which the heat transfer surface is engaged, with the diode junction preferably being at or near an equilibrium temperature during a slow gradual heat cycle.
  • the temperature indication signal provided by the low-power, between heating pulse can be used as a feedback control signal.
  • the array ideally comprises a two-dimensional array, and feedback signals from multiple heat transfer surfaces ofthe array should allow very good control ofthe local tissue contraction temperature throughout the treatment surface/tissue interface.
  • Such an array of transistors or diodes coupled to a power source via conductor 28 and printed circuit board 74 provides a very inexpensive way to selectively control the temperature across treatment surface 24.
  • Fig. 12A is an exemplary circuit including the probe of Fig. 12.
  • a large variable current II is sufficient to heat diodes 72 so as to treat the engaged tissue, preferably under proportional control.
  • a small constant current 12 does not significantly heat the engaged tissue, but does allow measurement ofthe forward voltage drop across each diode. Applying a constant small current 12, the voltage drop across a diode 72 thermally coupled (through a metal plate) to the tissue will be about 0.7 v - 2 mV/°C for a silicon diode so as to indicate the tissue temperature.
  • an EEPROM or other non-volatile memory may store calibration data for each diode, ideally storing calibration constants for at lest two temperatures from calibration tests conducted prior to delivery and/or use ofthe probe.
  • a conduit 76 directs a relatively high temperature fluid along a serpentine path adjacent treatment surface 74, the heated fluid typically comprising steam or the like.
  • a one dimensional array of elongate electrodes 80 is distributed across treatment surface 24, with irrigation ports 82 being disposed between and/or around the electrodes.
  • the midline need not be dissected, as described above. This minimizes the possibility of inadvertently treating and/or injuring the urethra.
  • treatment can be made symmetric by statically positioning the probe against the target region on the left side ofthe endopelvic fascia, and statically positioning the same or a different probe on the right side ofthe endopelvic fascia without accessing the fascia adjacent the urethra.
  • probe body 22 can be understood with reference to Fig. 15.
  • Probe 20 flexes when held against endopelvic fascia EF by a force F to ensure engagement between treatment surface 24 and the endopelvic fascia throughout the desired interface region.
  • probe body 22 may be pre-curved to facilitate coupling between the treatment surface and the target tissue.
  • a thin flat probe body which is slightly convex might be held against the target tissue by pressure F2 at the edges ofthe treatment surface (rather than a central pressure F) until the device becomes substantially flat, thereby indicating to the surgeon that the proper amount of tissue engaging pressure is being applied.
  • Fig. 16 illustrates a structure and method for aligning probe body 22 along the endopelvic fascia so that treatment region 40 is separated from the urethra by a protection zone 86.
  • a catheter 88 is introduced into the urethra, which facilitates identification ofthe urethra along the endopelvic fascia.
  • cooled water may be circulated through the catheter to avoid any injury to the urethra during treatment. It should be understood that such a urethral cooling system may be desirable for many embodiments ofthe present systems and methods.
  • urethra To facilitate aligning treatment surface 24 with target region 40, urethra
  • the probe body 22 may extend bilaterally on both sides ofthe urethra to simultaneously treat the left and right portions ofthe endopelvic fascia, as is indicated by the dashed outline 90.
  • Such a bilateral system can avoid injury to the urethral tissues by heating two (left and right) discrete treatment regions separated by a protection zone.
  • Bilateral systems might evenly treat the two sides ofthe endopelvic fascia by sequentially energizing two separated arrays of electrodes in a mirror-image sequence, the two sides being treated simultaneously, sequentially, or in an alternating arrangement.
  • the static tissue contraction probes ofthe present invention may optionally include an expansion mechanism such as balloon 92 to urge treatment surface 24 against the target tissue.
  • the device might again be inserted through incisions into the anterior vaginal wall on either side of the urethra.
  • Electrodes 26 are again mounted on a probe body 22 which is at least semi-rigid, with a resilient balloon 92 molded to the back of the probe body.
  • the balloon can be inflated after the probe is positioned to urge treatment surface 24 against the target tissue with a repeatable electrode/fascia interface pressure.
  • Balloon 92 will preferably comprise an elastomer such as silicone or the like.
  • defibrillator gel or saline may be provided at the treatment surface/tissue interface.
  • These enhanced coupling materials may be placed on the probe or tissue surface prior to engagement therebetween, or may alternatively be delivered through ports adjacent the electrodes.
  • Figs. 18A-C illustrate a still further alternative probe structure.
  • an expandable probe 94 is inserted through a small incision while the probe is in a narrow configuration.
  • balloon 96 is inflated via an inflation lumen 98. The balloon expands against an opposing tissue so as to urge treatment surface 24 against the endopelvic fascia.
  • fluid is passed through conduits adjacent the treatment surface to thermally treat the endopelvic fascia.
  • a hot fluid conduit 100 is arranged in a serpentine pattern which alternates with a cold fluid conduit 102 so that the treatment surface comprises interspersed zones of heating and cooling. Heating tissues to a safe contraction temperature between cooled zones will induce contraction with less injury to the tissue than would otherwise be imposed, as the regions of heated tissue are interspersed with, and protected by, the tissue cooling.
  • tissue heating and cooling are interspersed using a device which includes a heated plate 104 having a series of heated protrusions 106 in combination with a cooled plate 108 having interspersed cooled protrusions 110 and passages 112. Passages 112 receive heated protrusions 106, while a thermally insulating material 114 insulates the plates surrounding the protrusions from each other and the target tissue.
  • This device may optionally make use of active resistive heating of the entire hot plate 104, in some cases with temperature feedback provided from a single temperature sensor.
  • hot plate 104 will preferably be thick enough so that heat transfer through the plate from protrusion to protrusion is sufficient so that the temperature gradient from one protrusion to another is negligible, allowing uniform treatment across the treatment surface.
  • protrusions 106 may not be actively heated while in contact with the target tissue. Instead, hot plate 104 may be heated prior to contact with the tissue so that heat transfer to the tissue is provided by the heat capacity of hot plate 104, as predetermined from the specific heat ofthe hot plate material, the quantity of hot plate material, and the like. In fact, the device may be preheated in an oven or the like, so that no active heating ofthe plate is provided for.
  • the plate has sufficient heat capacity to treat the tissue if applied to the tissue for a predetermined amount of time.
  • protrusions 106 may include resistive heating elements such as those described above regarding Figs. 11 A- 12, optionally using a combination of resistive heating and the heat capacity ofthe protrusions and/or plate.
  • cold plate 108 may include a chilled fluid conduit, thermoelectric cooling module, or the like for actively cooling the plate, and/or may make use ofthe heat capacity of the plate to passively cool the tissue through cooled protrusions 110.
  • Fig. 20 illustrates an energy transmission element which is self-limiting.
  • a heat transfer surface 116 (typically defined by a metal barrier) is heated by boiling an aqueous gel 118.
  • Gel 118 is boiled by a resistive heater 120, and the steam is directed through a nozzle 122 in an insulating material 124.
  • the heated steam heats the heat transfer surface 116.
  • insulating material 124 substantially blocks the heat from resistive heater 120 from reaching the heat transfer surface 116.
  • this provides a maximum temperature determined by the boiling point ofthe aqueous gel, without requiring a temperature sensor.
  • the maximum amount of heat delivered to the tissue is determined by the initial mass of the aqueous gel provided.
  • Fig. 21 schematically illustrates a kit 130 including probe 20 and its instructions for use 132.
  • Probe 20 may be replaced by any of the probe structure described herein, while instructions for use 132 will generally recite the steps for performing one or more ofthe described methods.
  • the instructions will often be printed, optionally being at least in-part disposed on the packaging.
  • the instructions may alternatively comprise a video tape, a CD-ROM or other machine readable code, a graphical representation, or the like showing the above methods.
  • a rolling probe 202 includes a roller 204 on which a plurality of electrodes 206 are mounted. More specifically, electrodes 206 extend radially outward from roller 204 on posts. A temperature sensor 208 may be mounted on each electrode 206, or may alternatively be disposed between the electrodes, on pins extending radially outwardly from roller 204 into the target tissue, or the like.
  • a surgeon maneuvers a probe body or a handle 210 so that roller 204 rolls against endopelvic facia EF.
  • electrodes 206 will be spaced so that two or more electrodes will be in contact with the facia F at all times.
  • a controller may determine which electrodes are in contact with the tissue. The controller may also measure the tissue temperature using sensor 208. The controller will drive radiofrequency current between a pair of electrodes 206 while the 2 electrodes engage the endopelvic facia EF until the temperature under the forward temperature indicator reaches the target temperature for sufficient time to effect contraction. The controller may then indicate to the operator that is time to roll roller 204 forward.
  • an alternative rolling probe 212 is similar in structure and operation to rolling probe 202 of Fig. 22.
  • an axially elongate roller 204 supports elongate electrodes 206 . While each pair of elongate electrodes 206 engage the target tissue, bipolar current can be driven therebetween as described regarding the static devices above. Hence, it should be possible to selectively contract tissue in a particular orientation (for example, circumferentially) using the probe Fig. 23.
  • Still further alternative rolling probe shapes may be provided.
  • a spherical rolling member may have elongate electrodes or multiple rows of posts.
  • a small tissue sensing current may be driven between all the alternating electrodes by the control system. Electrical characteristics (resistance, impedance, or the like) of any tissue engaged by the electrodes may provide a signal to the controller indicating which electrodes are in contact with the target tissue.
  • Fig. 24 schematically illustrates a simple tissue contraction system 220 in which a single tip probe 222 is coupled to a control unit 224 by a plurality of conductors 226.
  • Probe 222 includes a handle of insulating material which supports a metal tip 228.
  • 228 includes a resistive heater 230 powered by the control unit.
  • Tip 228 will generally be heated by resistive heater 230 prior to engaging the target tissue. Resistive heater 230 will generally heat 228 to a predetermined temperature using feedback control. Tip 228 will generally be heated to a temperature of between about 70 °C and 140 °C before the probe engages the tissue. Once tip 228 is at the desired temperature, a first light 232 on control unit 224 may be illuminated to indicate that the probe is ready. An end surface 234 of tip 228 is then manually pressed against the tissue to be treated.
  • the temperature ofthe tip is monitored when the tip is pressed against the tissue. As the tip heats the tissue, the power required to keep the tip at a particular temperature will drop. Once the power requirement drops to a predetermined level, the controller may indicate that the tissue has been adequately treated by illuminating a second light 234. Alternatively, control unit 224 may simply terminate heating of tip 228 until probe 222 no longer engages the tissue surface. In some embodiments, control unit 224 will both turn off heating power and indicate that it is time for the operator to lift the probe from the treatment surface. Once the tip has been lifted, the controller will again initiate heating. The surgeon will again wait for tip 228 to reheat, and then apply it to the next treatment sight.
  • Treatment surface 234 may be round as shown, or may alternatively be square, hexagonal, or the like.
  • control unit 224 may determine that treatment is complete by monitoring a temperature of tip 228. When the tip first engages the tissue, the temperature will drop. If control unit 224 continues to apply heating power to resistive heater 230, the temperature of tip 228 will then begin to rise. Once tip 228 is heated back to desired value, control unit 224 may terminate heating, indicate that the engage tissue is fully contracted, or the like. Alternatively, control unit 224 may monitor the total heat transferred from probe 222. Still further alternatives are also possible, including a simple measurement ofthe time in which tip 228 engages the tissue.
  • System 220 may also be used in a passive heat-limited mode. By making use of a tip 228 having sufficient thermal mass, the thermal energy stored in tip 228 can be sufficient to heat and contract the engaged tissue. In this mode, tip 228 is pre-heated using resistive heater 230. Once the tip is at the desired temperature, heating ofthe tip is terminated by controller 224, and the tip may be engaged against the tissue without fear of over-treatment.
  • temperature sensors may be mounted on probe 222 to monitor the temperature of tip 228, the tissue engaged by tip 228, or tissue at some depth from the probe (using needle mounted sensors or the like).
  • the temperature of tip 228 may optionally be monitored using an electrical characteristic of resistive heater 230.
  • a probe having a rolling element similar to that illustrated in Fig. 22 may include protrusions which are pre-heated to passively heat the endopelvic facia EF through thermal conduction, as described with reference to Fig. 24. While the exemplary embodiments have been described in some detail, by way of example and for clarity of understanding, a variety of modifications, changes, and adaptations will be obvious to those of skill in the art. Therefore, the scope ofthe present invention is limited solely by the appended claims.

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Abstract

L'invention concerne des dispositifs, procédés, et systèmes améliorés permettant de contracter de manière à la fois sûre et répétée le fascia et d'autres tissus, en particulier pour traiter l'incontinence urinaire. Plutôt que de reposer sur la capacité d'un chirurgien à observer, à diriger, et à réguler la contraction sélective des tissus de support pelvien, on utilise des sondes (20) pour limiter généralement le transfert de chaleur, de sorte que seule une énergie régulée suffisante est transmise à ces tissus depuis la surface d'une sonde (20), afin de contracter ces tissus et d'inhiber l'incontinence (ou, dans une variante, de fournir le résultat thérapeutique souhaité).
PCT/US1999/016548 1998-07-31 1999-07-22 Dispositifs de transfert de chaleur limite et procedes pour contracter des tissus WO2000006035A1 (fr)

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US9494698P 1998-07-31 1998-07-31
US60/094,946 1998-07-31
US09/170,940 US6067270A (en) 1997-11-21 1998-10-13 Multi-bank memory devices having improved data transfer capability and methods of operating same
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US7332029B2 (en) 2002-01-18 2008-02-19 Neuro Probe Incorporated Crystal forming apparatus and method for using same
US11896823B2 (en) 2017-04-04 2024-02-13 Btl Healthcare Technologies A.S. Method and device for pelvic floor tissue treatment

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US5599349A (en) * 1994-09-30 1997-02-04 Circon Corporation V shaped grooved roller electrode for a resectoscope
US5643924A (en) * 1992-05-21 1997-07-01 Monsanto Company Of St. Louis Retroviral protease inhibitors
US5669906A (en) * 1994-09-30 1997-09-23 Circon Corporation Grooved roller electrode for a resectoscope
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US5643924A (en) * 1992-05-21 1997-07-01 Monsanto Company Of St. Louis Retroviral protease inhibitors
US5569242A (en) * 1994-05-06 1996-10-29 Lax; Ronald G. Method and apparatus for controlled contraction of soft tissue
US5599349A (en) * 1994-09-30 1997-02-04 Circon Corporation V shaped grooved roller electrode for a resectoscope
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Publication number Priority date Publication date Assignee Title
US7332029B2 (en) 2002-01-18 2008-02-19 Neuro Probe Incorporated Crystal forming apparatus and method for using same
US11896823B2 (en) 2017-04-04 2024-02-13 Btl Healthcare Technologies A.S. Method and device for pelvic floor tissue treatment

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