Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/12—Devices for heating or cooling internal body cavities
  • A61F7/123—Devices for heating or cooling internal body cavities using a flexible balloon containing the thermal element
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/0085—Devices for generating hot or cold treatment fluids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water

Definitions

• the present invention relates to systems and methods of delivering minimally invasive thermal therapies in a lumen or body cavity of a subject and is particularly suitable for treatment of certain conditions ofthe prostate.
• U.S. Patent No. 6,216,703 describes certain thermal treatment systems (including microwave energy systems) that can allegedly be used to treat both prostatitis and BPH (benign prostatic hyperplasia).
• BPH and prostatitis while both disorders ofthe prostate, are themselves distinct and different conditions and each typically is treated with different treatment strategies and therapies. Additional discussion of prostatitis and suitable treatments is found in co-pending and co-assigned U.S. Provisional Patent Application Serial No. 60/308,344, entitled, Methods of Treating Prostatitis, the contents of which are hereby incorporated by reference as if recited in full herein.
• the circulating hot water is directed through the treatment catheter which is inserted into the penile meatus up through the penile urethra and into the prostate as described above.
• the treatment segment expands with the hot water held therein to press the inflated treatment segment against the prostate, which then conductively heats and thermally ablates the prostatic tissue.
• the circulating water is typically heated to a temperature of about 60°-62°C and the targeted tissue is thermally treated for a period of about 35-45 minutes to locally kill the tissue proximate to the urinary drainage passage in the prostate and thereby enlarging the prostatic urinary passage.
• Embodiments ofthe present invention are directed to providing modular treatment systems, computer program products, methods and devices with enhanced operational features.
• the modular systems include control consoles that are compact and relatively lightweight and catheter assemblies that are configured with a modular cassette that is configured so as to releaseably matably connect to the console during use.
• the console includes a controller, a pump, user input keypad, operational circuitry, display, and power source.
• the console includes a cassette-receiving surface that is configured to matably receive and hold the cassette so that the pump is able to operably engage therewith.
• the cassette housing is configured to securely hold a length of conduit that forms a portion ofthe closed loop fluid circulation flow path as well as selected electronic circuitry.
• the conduit is held in the cassette housing such that it is encased about a portion ofthe cassette housing, exits at a first location in the cassette, and then enters the cassette at a second spatially separate location so as to provide an externally accessible length of conduit.
• the externally accessible length may have a curvilinear configuration.
• the controller can also have computer program code for: (a) disabling operating circuitry in the cassette after the treatment catheter has been used for one treatment procedure (making the cassette and catheter a disposable assembly to promote single-use catheters); (b) automatically deflating the treatment balloon (before introduction or removal ofthe catheter); (c) activating a high speed air bubble purge procedure to filter air bubbles from the circulation path; (d) generating a patient record of treatment; (e) providing predetermined selectable treatment protocols; (f) performing a trouble shooting self-diagnostic test; and (g) automatically recording treatment parameters associated with the delivery of a patient's therapy.
• the systems, methods, and computer program products can be used to treat urinary or prostate disorders or conditions such as prostatitis, BPH, or cancer, or to treat other tissues adjacent or proximate a natural body lumen or cavity.
• the pre-programmed treatment protocols can be for different therapies associated with different conditions ofthe prostate including both BPH and prostate.
• the circulating liquid can be heated to 57°-62°C or higher external ofthe subject and directed into the treatment catheter at an inlet temperature of above about 57°- 62°C or higher for at least about 10-20 minutes.
• Certain embodiments ofthe present invention are directed toward ambulatory thermal treatment systems having a closed loop liquid circulation path.
• the systems can include: (a) a portable control console having opposing front and rear portions and a cassette mounting region; and (b) a cassette housing sized and configured to be releaseably mounted to the console at the console mounting region.
• the console includes a power supply, a controller operably associated with the power supply, and a pump operably associated with the controller.
• the pump is configured to circulate liquid through a closed loop circulation path to administer a desired thermal therapy to a patient.
• the cassette is sized and configured to be releaseably mounted to the console at the console mounting region and the cassette houses a portion ofthe closed loop circulation path.
• the cassettes include: (a) a cassette housing configured with opposing front and rear surfaces, wherein the cassette is sized and configured to be releasably mounted to a control console that controls the administration of a thermal therapy to a subject; (b) a pressure sensor held in the cassette; (c) a cylindrical heater having a central liquid flow channel therethrough held in the cassette; (d) a temperature sensor operably associated with the heater held in the cassette; (e) an externally accessible power interface connection operably associated with the heater, temperature sensor, and pressure sensor; and (f) a length of flexible conduit held in the cassette defining a portion of a circulating liquid flow path, a portion ofthe length of flexible conduit being in communication with the heater.
• Additional embodiments are directed to single-use disposable catheter assemblies.
• the catheter assemblies include: (a) a modular cassette housing having opposing front and rear surfaces, the cassette housing a portion of a circulating liquid flow path; and (b) a treatment catheter configured for insertion into the natural lumen or body cavity of a subject, the treatment catheter having an expandable treatment balloon thereon.
• the treatment catheter defines another portion ofthe circulating liquid flow path and is in fluid communication with the portion ofthe liquid circulating flow path held in the cassette.
• FIG 2 is a side perspective view ofthe console and catheter assembly shown in Figure 1, with the catheter assembly mounted onto the console according to embodiments ofthe present invention.
• Figure 3 is an enlarged view ofthe console shown in Figure 1.
• Figure 7A is an enlarged partial side view ofthe cassette being aligned with the console for attachment thereto according to embodiments ofthe present invention.
• Figure 7B shows the device of Figure 7A with the cassette held in its mounted position against the console according to embodiments ofthe present invention.
• Figure 9 is an opposing side view ofthe device shown in Figure 8.
• Figure 10 is an enlarged front perspective view ofthe device shown in Figure 8 and with the cassette cutaway.
• Figure 21 is pressure control circuit diagram for controlling the pressure in a closed loop system according to embodiments ofthe present invention.
• Figure 22 is a power interface circuit diagram according to embodiments of the present invention.
• the pump 50 is a peristaltic pump with rollers that compress the liquid in the conduit to circulate the liquid in the closed loop system. As such, in proper position, the pump head 50h is able to firmly abut the conduit 24e to compress the conduit 24e in response to a desired pump speed (typically described in a rate of revolutions per minute (rpm)).
• a suitable pump identified by part number 313D (a three roller peristaltic pump with product code 033.3411.000) is available from Watson Marlow, Inc., of Paramus, NJ.
• the tubing or conduit 24 extends from the catheter, a distance in the body ofthe cassette 26, exits at a first location on the cassette 26a ⁇ , enters at a second location 26a2 spaced apart from the first location 26al, and extends out of the cassette 26 and connects to the catheter 22.
• the catheter 22 and the tubing or conduit 24 defines the primary circulation flow path 18f having an inlet channel 24i and outlet channel 24o with respect to the catheter 22 that in operation circulates the thermally treated liquid from and to the expandable treatment balloon 22b.
• the externally accessible pump engaging portion of the conduit 24e is curvilinear or arcuate and bridges two opposing members or arms 26al, 26a2 ofthe cassette 26.
• the system operating pressure (typically ranging from about 0.5 atm- 7 atm or even larger) can be monitored and the pressure adjustment may be carried out to so as to maintain the pressure or adjust the pressure with a pressure resolution of between about 0.01-0.10 psi.
• the input devices include a plurality of membrane switches 131 (that can operate as functional softkeys, the response or input ofthe keys varying based on the step in the procedure) and a membrane arrow scroll pad 132.
• These input devices 30i allow an operator to select pre-programmed treatment procedures or define in situ a desired treatment procedure protocol (temperature, times, and pressures, as desired) and also allows the clinician to enter patient data.
• the console 30 may also include a printer data port 135a ( Figure 5) to allow a clinician to download operation or patient record information.
• Figure 5 illustrates the rear side ofthe console 30.
• the console 30 includes a fan 34 located in fluid communication with the lower portion ofthe console 30 and an air vent 134 located in a top portion ofthe console 30.
• Figures 8-12 illustrate different views ofthe interior components and their locations in the top or bottom compartment 130t, 130b, according to embodiments ofthe present invention.
• Figure 8 illustrates one side view ofthe console 30 and cassette 26.
• the power supply 175 that converts the AC input power (that can accept either 110 or 220 AC) to 24DC is located in the rear ofthe unit.
• a medical grade power supply is available from CONDOR of California.
• the graphic display circuitry 331 is positioned in compartment 130t proximate the display 31.
• the user input overlay 310 is shown where the membrane switches are located.
• FIG 9 illustrates the opposite side view of that shown in Figure 8.
• the pump 50 includes a pump (stepper) motor 50m (24V DC) and is operably associated with a disc 50d with teeth located about its perimeter.
• a photo optical sensor 50s is positioned to extend over a perimeter portion ofthe disc 50d so as to be able to optically read and count the speed of rotation ofthe pump 50.
• the system 10 can be configured to generate an alert if the pump speed does not correspond with the selected mode of operation (such as if the pump has an irregular low speed indicating a potential malfunction that may lead to an overheating condition).
• Figure 10 is a front perspective view with the cassette housing (front and back covers or walls) removed. As shown, the console 30 includes a rear metal wall 30r and a metal floor 30b. Figure 11 illustrates a partial side view enlarged relative to the view of Figure 8.
• Figure 12 is a partial view ofthe back ofthe console 30 with the back wall removed.
• An on off power switch 135p is shown as well as a DC-DC power supply 275 that steps down the voltage from the 24V DC to power certain lower power circuit components.
• the pressure adjustment mechanism assembly 300 (shown in detail in Figure 13) with its associated stepper motor 342, screw 342s, and nut 342n is also shown with respect to its placement in the console 30.
• FIGS 6A-6C illustrate a series of operational configurations according to embodiments ofthe present invention.
• the catheter assembly 20 with cassette 26 can be supplied separately and then mated to the console 30 at the use site.
• the console 30 is a multi-use device that can engage with any suitable catheter assembly 20 with a cassette 26 and any catheter configuration desired, the configuration will of course, correspond to the planned use in a desired region in the body.
• the pump 50 is configured to mate with the cassette 26 without requiring that an operator connect several loose hanging leads.
• the conduit 24 can extend from an end region ofthe cassette 26.
• Figure 6B illustrates the cassette 26 mounted to the console 30.
• valve 150v can be formed by an elliptically shaped cam member 150c that rotates to force fingers 150f to expand outwardly away to compress the proximately positioned flow path shut against a stationary wall member and open the other flow path at desired times. Directing the liquid to travel through the container forces the air bubbles into the top portion ofthe bag 250 out ofthe liquid flow path 18f.
• the cassette 26 may be configured with a window 150w ( Figure 15) that allows a clinician to view the air bubble filtration.
• FIGS. 20-25 illustrate exemplary circuit schematics according to embodiments ofthe present invention.
• Figures 26 A and 26B illustrate a circuit board 240 that includes a heat sensor 140 used as a re-use deterrent mechanism.
• the system 10 may optionally include a user interface in communication with the controller to allow a user to adjust the pressure to a custom comfort level.
• This interface can be a joystick-type peripheral device, a touch screen on a display, a key input or membrane touch switch (such as an arrow) on a keypad, or a voice activated input ("raise” and “lower” or “pressure up” and “pressure down”), or other desired input means.
• the controller can include means to limit the pressure that the patient can introduce into the system (which may be combined with when the input can be operated), and thus, have a control override to a desired normal range of operation.
• the console can be configured as a vertical-rise housing with a reduced footprint to reduce the amount of square feet of real estate used in clinician or hospital facilities.
• the modular cassette is a substantially rigid body that is attached to the catheter and configured with a catheter repeat-use deterrent system (to promote hygienic sterile single uses).
• the controller can have computer program code for (a) activating the pump, the heater, the temperature sensors, the pressure sensor and the pressure adjustment device to substantially continuously circulate heated liquid through the liquid circulation path at a controlled pressure and temperature; and (b) automatically adjusting the pressure in the liquid circulation path to compensate for operational pressure losses or to operate the system at a selected pressure at a desired time.
• the adjustment can be carried out to account for any physiological changes in the tissue proximate the targeted treatment region (such as in the prostatic urethra) so that the system maintains at least one selected operating pressure during administration ofthe thermal therapy.
• the system is configured to accept user input in situ to set the desired operating pressure(s), and other embodiments a series of increasing pressures are used to apply an increased pressure concurrently with heat at the target site in the body.
• the controller can also have computer program code for: (a) disabling operating circuitry in the cassette after the treatment catheter has been used for one treatment procedure (making the cassette and catheter a disposable assembly to promote single-use catheters); (b) automatically deflating the treatment balloon at the end ofthe procedure before removal ofthe catheter (and/or at the beginning of the procedure post priming and before insertion into the subject); (c) activating a high speed air bubble purge procedure to filter air bubbles from the circulation path; (d) generating a patient record of treatment; (e) providing predetermined selectable treatment protocols; (f) performing a trouble shooting self-diagnostic test; and (g) automatically recording treatment parameters associated with the delivery of a patient's therapy.
• the system 10 can be configured to resist disconnection or to impede the withdrawal ofthe catheter from the subject until the pressures in the anchoring balloon 22a and the treatment balloon 22b indicate a deflated state.
• Other catheter configurations can also be used as noted above (including those for sized and configured for arterial uses, female urinary, urethra, endometrium, uterine, or other body lumens, or cavities. See, e.g., U.S. Patent No.
• the circulating heated fluid for thermal ablation treatments can be heated to temperatures above about 45°C and delivered to the targeted tissue to provide the thermal temperatures for different applications for different lengths of treatment as the desired application dictates. For example, this can be carried out by heating the circulating temperature to at least about 50°C and then circulating the heated liquid into the catheter, which is positioned in the desired location in the subject so as to expose the targeted tissue to the heated circulating temperature for about 5-90 minutes, and typically about 20-45 or 20-60 minutes.
• a suitable thermal treatment system and treatment catheters are available from ArgoMed, Inc. located in Cary, North Carolina. See also, U.S. Patent Nos.
• the circulating fluid (and the anchoring balloon inflation media, when separately inflatable) is preferably selected to be non-toxic and to reduce any potential noxious effect to the subject should a situation arise where the balloon integrity may be compromised, accidentally rupture, leak, or otherwise become impaired during service.
• the catheter 22 can be flexibly configured so as to be able to bend and flex to follow the shape ofthe lumen or cavity as it is introduced into the lumen or cavity until a distal portion ofthe catheter 22 reaches the desired treatment site.
• the flexible catheter 22 can also be configured such that it is sufficiently rigid to be able to maintain an opening in the drainage lumen 28 when inserted and in position in situ (and exposed to increased system pressures of about 0.5-3 atm, and typically at least about 1-2 atm during at least a portion ofthe thermal therapy) so that the catheter is configured to retain at least about 50% ofthe cross-sectional area, and preferably at least about 75%-90% or more, ofthe cross-sectional area, of the drainage lumen 28 relative to the pre-insertion catheter size.
• the catheter 22 can be configured such that it is able to maintain a sufficiently sized drainage opening in the drainage lumen 28 to allow desired flow volumes therethrough when exposed to compressive pressures from the treated tissue on the order of about 0.5 atm (7 psi)- 2 atm (28 psi) or 3 atm (42 psi) after exposure to elevated temperatures above about 45°C for at least about 5-10 minutes, and more preferably for above about 20-30 minutes.
• the catheters 22 ofthe instant invention can also be used to maintain an open passage of desired size for other treatments or applications where there is a desire to maintain the open passage in a flexible catheter which is exposed to edema or stress in the subject. See co-pending and co-assigned U.S. Patent Application No. 10/011,700 for additional description of suitable catheter configurations, the contents of which are hereby incorporated by reference as if recited in full herein.
• the Merit and Medex transducers are rated for a compensated pressure range of -10 to 300 mm Hg (maximum design pressure of about 5 psi) and may be used to measure up to about 20 psi in the system.
• Another sensor 15s type is a digital pressure gage with a digital readout in bars (the HBM model as noted above). The gage can be mounted off of a "T" connection with the tubing 24. The T connection can be sized so as not to constrict flow with openings larger than the (2.5 mm) inner diameter ofthe tubing.
• FIG. 17 one embodiment of a pressure adjustment device is shown.
• This embodiment employs a syringe 40 with a quantity of liquid held therein.
• a plunger or piston 40p is used to direct fluid out of or into the syringe 40 from a supplemental fluid path 18s.
• a Y connector 72 defines a junction between the liquid circulation path 18f and the supplemental fluid (adding and removing) path 18s.
• Other connector or joint types can also be used (such as T's or other configurations).
• the patient may control the pressures during substantially the entire active thermal treatment (T) or at selected portions ofthe treatment. For example, at an initial Tl, or subsequent portion ofthe freatment, Ti.
• the pressure increments may vary depending on the patient's tolerance for pain (shown by the different pressure lines, numbered as "1" and "2"). It is contemplated that when a patient has some control over the procedure, he may be more apt to select or willing to experience greater pressures.
• the system can be programmed with a safety override that prevents over-pressures from being selected (shown by the upper limit in the figure).
• a lower limit can be set so that the patient cannot select non-suitable operating conditions (not shown ).
• the upper and lower limits may be a constant value or can be altered depending on the duration or point in time in the treatment (not shown).
• These computer program instructions may also be stored in a computer- readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function or functions specified.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Physics & Mathematics (AREA)
• Thermal Sciences (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (4)

Applications Claiming Priority (2)

Publications (2)

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Cited By (10)

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• 2002
  • 2002-12-12 WO PCT/US2002/039758 patent/WO2003054660A2/en active Application Filing
  • 2002-12-12 AU AU2002353129A patent/AU2002353129A1/en not_active Abandoned
  • 2002-12-12 DE DE10297559T patent/DE10297559T5/de not_active Withdrawn
  • 2002-12-12 JP JP2003555308A patent/JP2005514085A/ja not_active Withdrawn

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