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WO2003033045A2 - Catheters presentant une capacite d'aspiration, procedes et systemes associes permettant d'obtenir des bio-echantillons in vivo - Google Patents

Catheters presentant une capacite d'aspiration, procedes et systemes associes permettant d'obtenir des bio-echantillons in vivo Download PDF

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Publication number
WO2003033045A2
WO2003033045A2 PCT/US2002/030354 US0230354W WO03033045A2 WO 2003033045 A2 WO2003033045 A2 WO 2003033045A2 US 0230354 W US0230354 W US 0230354W WO 03033045 A2 WO03033045 A2 WO 03033045A2
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WO
WIPO (PCT)
Prior art keywords
catheter
fluid
treatment
balloon
prostatic
Prior art date
Application number
PCT/US2002/030354
Other languages
English (en)
Other versions
WO2003033045A3 (fr
Inventor
Iulian Cioanta
Jacob Lazarovitz
Richard Barry Klein
Original Assignee
Wit Ip Corporation
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
Application filed by Wit Ip Corporation filed Critical Wit Ip Corporation
Priority to AU2002337679A priority Critical patent/AU2002337679A1/en
Priority to JP2003535846A priority patent/JP2005505384A/ja
Priority to EP02773564A priority patent/EP1441779A4/fr
Publication of WO2003033045A2 publication Critical patent/WO2003033045A2/fr
Publication of WO2003033045A3 publication Critical patent/WO2003033045A3/fr
Priority to US10/827,741 priority patent/US20050054994A1/en

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • 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
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/046—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in liquid form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0036—Multi-lumen catheters with stationary elements with more than four lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Definitions

  • the present invention relates to catheters configured for insertion into a lumen or body cavity of a subject, and is particularly suitable for catheters configured for insertion into the male urethra.
  • thermal treatment systems have been proposed to treat certain pathologic conditions of the body by heating or thermally ablating targeted tissue.
  • These thermal treatment systems have used various heating sources to generate the heat necessary to treat or ablate the targeted tissue.
  • laser, microwave, and radio-frequency (RF) energy sources have been proposed to produce heat that is then directed to the targeted tissue in or around the selected body cavity.
  • RF energy sources have been proposed to produce heat that is then directed to the targeted tissue in or around the selected body cavity.
  • Thermal treatment systems have been used to thermally ablate prostate tissue as well as to thermally treat or ablate the tissue of other organs, body cavities, and/or natural lumens.
  • Other proposed treatments include balloon dilatation applied internally without the concurrent application of heat.
  • thermal ablation system ablates the prostate by a thermocoagulation process.
  • This thermal ablation system employs a closed loop liquid or water-induced thermotherapy system that heats liquid, typically water, external to the body and then directs the circulating heated water into a treatment catheter.
  • the treatment catheter is inserted through the penile meatus and held in position in the subject prior to initiation of the treatment to expose localized tissue in the prostate to ablation temperatures.
  • the treatment catheter includes an upper end portion which, in operation, is anchored against the bladder neck and an inflatable treatment segment which is held relative to the anchored upper end portion such that it resides along the desired treatment region of the prostate.
  • the treatment segment expands, in response to the captured circulating fluid traveling therethrough, to press against the targeted tissue in the prostate and to expose the tissue to increased temperatures associated with the circulating liquid, thereby thermally ablating the localized tissue at the treatment site, h addition, the pressurized contact can reduce the heat sink effect attributed to blood circulation in the body, thus enhancing the depth penetration of the heat transmitted by the inflatable treatment segment into the prostatic tissue.
  • thermotherapy As an acceptable alternative to surgery (transurethral resection of the prostate (TURP)), the use of water-induced thermotherapy has been shown to be a successful and generally minimally invasive treatment of BPH (benign prostatic hyperplasia).
  • BPH benign prostatic hyperplasia
  • the term "BPH” refers to a condition wherein the prostate gland enlarges and the prostatic tissue increases in density that can, unfortunately, tend to close off the urinary drainage path. This condition typically occurs in men as they age due to the physiological changes of the prostatic tissue (and bladder muscles) over time.
  • 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 45 minutes to locally kill the tissue proximate the urinary drainage passage in the prostate and thereby enlarge the urinary passage through the prostate.
  • prostatitis can occur in both younger (men in age groups of 18-50 (or younger)) and older men (over the age of 50), with the median reported patient age at about 40 years of age. See id. at 1228. It is thought to be the most common urologic diagnosis for men less than 50 years of age.
  • Type I acute bacterial prostatitis
  • Type II chronic bacterial prostatitis
  • Type HI chronic non-bacterial
  • CPPS chronic pelvic pain syndrome
  • Type IN asymptomatic inflammatory prostatitis
  • Type HI prostatitis class non-bacterial chronic prostatitis
  • Type III prostatitis may be further defined as IJIA (inflammatory) or IJIB (noninflammatory).
  • IJIA inflammatory
  • IJIB noninflammatory
  • the IDA inflammatory type prostatitis can be identified based on the presence of leukocytes in expressed prostatic secretions or fluids, post prostatic massage urine, or semen, while the IHB non-inflammatory type can be identified based on the absence of detectable leukocytes in similar specimens.
  • This type of prostatitis may also be associated with variable voiding, sexual dysfunction, and/or psychologic alterations (particularly depression).
  • the present invention provides catheters and related systems, methods, and computer program products that can capture biofluids and/or biosamples in vivo, and/or that may enhance the treatment of certain diseases of the body when the catheter is used both to apply a dilatation and/or thermal therapy to a targeted region in a cavity or lumen of the subject.
  • the present invention may be particularly suitable for collecting prostatic fluid samples and/or for treating diseases of the prostate such as BPH, prostatitis, and cancer.
  • the catheter can be configured to administer a thermal therapy to the targeted region.
  • the thermal therapy can be applied with an internal massage.
  • the collecting or capturing of the biofluids can comprise suctioning the biosamples. The collecting may be carried out continuously, semi-continuously, or at selected times over the course of the treatment. The concurrent combination of pressure and/or heat (thermal with an internal massage therapy) with suctioning may provide increased therapeutic responsiveness over massage and/or thermotherapies alone.
  • drawing biofluid from the prostate may enhance the efficacy of the treatment and/or can provide prostatic fluid specimens that are substantially void of urine.
  • the quantity of biofluid released over the treatment period can be monitored and analyzed (flow rate/volume etc.) to evaluate the treatment delivered with internal tissue activity in the body.
  • the thermal treatment period can extend from about 5 min to about 90 min (or longer).
  • the thermal therapy can be administered by employing circulating heated fluid in the catheter. As such, the fluid can be heated, but controlled, so that the prostatic temperature is exposed to predetermined temperatures for selected time periods. The duration of the treatment may not include the initial time to reach the desired treatment temperature (or the time to decrease therefrom post-treatment).
  • the catheter can be used to capture a biosample of the prostatic fluid to monitor the efficacy of a therapeutic agent or treatment regimen. This may allow easier identification of elevated or decreased levels (or the presence or absence) of an analyte(s) of interest.
  • the amount of biofluid collected over a particular period may be indicative of a disease state, condition, impairment in function of the prostate.
  • the catheters and methods provided by certain embodiments of the present invention can capture the biofluid specimen in a manner that provides the specimen ex vivo in substantially the same condition (concentration/constituents) as it was in vivo at entry into the catheter.
  • the collection of the biosample can be performed such that it is obtained concurrently with, after, or before a radiation treatment (or chemotherapy) to evaluate alterations in quantity or content of the collected biospecimen.
  • Certain embodiments of the present invention are directed to methods for obtaining a sample and/or treating a subject.
  • the method includes: (a) positioning an elongated transurethral catheter in the prostatic urethra of a subject, the catheter having a bladder anchoring balloon, at least one biosample entry port disposed axially away from the bladder anchoring balloon, and an axially extending biosample flow channel in fluid communication with the biosample entry port held internally in the catheter; (b) inflating the anchoring balloon to position the catheter so that the biosample entry port is proximate the prostatic or membraneous urethra of the subject; and (c) suctioning prostatic fluid from the prostatic urethra into the biosample entry port and into the biosample flow channel.
  • the method can be carried out so as to direct the prostatic fluid to exit the body so that the suctioned prostatic fluid is substantially void of urine and then capturing the prostatic fluid after it exits the body.
  • the method may include monitoring the quantity or flow rate of the captured fluid over a predetermined time.
  • the catheter may be configured to capture prostatic fluid at the acini region of the prostate, the fluid exiting this region may be enhanced by temporal thermal internal massage therapy.
  • Other embodiments are directed at methods for treating the prostate of a subject.
  • the operations of the method can include: (a) inserting a catheter into the urethra of a subject, the catheter having, in serial order from the most distal portion, a bladder anchoring balloon, at least one expandable treatment balloon, and at least one fluid entry port formed in the wall of the catheter, the catheter also having an axially extending biosample flow path in fluid communication with the fluid entry port disposed internal of the catheter wall; (b) expanding the bladder anchoring balloon to contact and reside against the bladder neck of the subject to secure the catheter in position in the subject; (c) heating fluid to a desired temperature; (d) directing heated fluid to travel captured in the catheter to the at least one expandable treatment balloon;
  • the suctioning step is carried out at least intermittently during the heating step. In other embodiments, the suctioning step is carried out substantially continuously during the heating step while in still other embodiments the suctioning step is carried out at a plurality of discrete intervals for a predetermined period of time during the treatment.
  • Still other embodiments are directed to methods of collecting a biosample in a subject.
  • the method includes: (a) inserting a catheter into the male urethra, the catheter having a biofluid travel path defined therein; (b) collecting a biosample from the prostatic urethra into the catheter in vivo; and (c) directing the collected biosample to travel in the biofluid travel path and to exit the body in a manner that keeps the biosample substantially void of urine.
  • the collecting step can suction the biosample and the method can also include the steps of applying heat to the prostatic urethra proximate in time to or during the collecting step and/or allowing urine to drain from the bladder of the subject during the collecting or suctioning step.
  • other embodiments are directed to methods of collecting a biosample in a subject that is substantially void of urine.
  • the operations include: (a) inserting a catheter into a urethra of a subject, the catheter having a biofluid travel path defined therein; (b) suctioning a biosample from a targeted location along the urethra into the catheter in vivo; and (c) directing the suctioned biosample to travel in the biofluid travel path and to exit the body in a manner that keeps the biosample substantially void of urine.
  • the urethra can be either the female or male urethra.
  • Still other embodiments are directed to sets of prostatic treatment catheters having expandable treatment balloons.
  • the treatment balloons are configured on a flexible catheter sized and configured to be inserted into the male urethra.
  • the treatment balloons are sized in about 0.5 cm increments from about 1 cm to 6 cm such that, a clinician can select one of the catheters having the desired length treatment balloon.
  • the treatment balloon having a length so that in position in the body it resides above the verumontanum of the subject in the prostatic urethra.
  • Each of the catheters also comprise a plurality of prostate drainage ports in communication with a prostate drainage lumen held internal of the catheter.
  • An additional embodiment of the present invention is directed toward a system for collecting a prostatic fluid specimen in vivo in a subject.
  • the system includes a transurethral elongated catheter having an outer wall.
  • the catheter has at least one prostate drainage port formed through the outer wall and an axially extending prostatic flow channel held therein.
  • the system can include a suction source in fluid communication with the at least one prostate drainage port.
  • the suction source provides a suction force sufficient to draw prostatic fluid into the at least one prostate drainage port and into the prostatic flow channel to thereby cause the prostatic fluid to flow out of the body of the subject so as to be collected for evaluation.
  • the system includes an elongated transurethral catheter having an outer wall.
  • the catheter comprises: (a) a plurality of axially extending internal fluid flow channels disposed in the catheter, an inlet circulating fluid channel, an outlet fluid circulating channel, a urinary drainage channel, and an axially extending prostatic fluid channel, wherein the prostatic fluid channel is in fluid isolation from the urine drainage and inlet and outlet channels; (b) an outwardly expandable treatment or dilatation balloon; (c) a bladder anchoring balloon; and (d) at least one prostate drainage port formed through the outer wall of the catheter in fluid communication with the prostatic fluid channel.
  • the system also includes a quantity of circulating fluid in the inlet and outlet channels; a heater operably associated with fluid traveling in the inlet and outlet channels; a pump operably associated with the circulating fluid to cause the fluid to circulate in the catheter; at least one temperature sensor operably associated with the heater and the circulating fluid in the inlet and outlet channels; and a suction source in fluid communication with the at least one prostate drainage port.
  • the suction source provides a suction force sufficient to draw prostatic fluid into the at least one prostate drainage port and into the prostatic flow channel to thereby flow out of the body of the subject so as to be able to be collected for evaluation.
  • the pump can be a pulsating pump configured to circulate the fluid in a pulsating flow.
  • the prostate drainage port can be a plurality of discrete ports spaced on the catheter such that, in position, they primarily reside proximate the verumontanum region.
  • the present invention is directed to computer program products for obtaining a biosample of the prostatic urethra.
  • the product includes: (a) computer readable program code for activating and applying a suction force to a fluid channel extending from a suction source located external of the body of the subject to the prostatic urethra via a catheter that is in fluid communication with the prostate; and (b) computer readable program code for drawing in and capturing a biosample comprising prostatic fluid in the catheter.
  • the captured biosample can be held so that it is substantially void of urine as it is directed to exit the subject in the catheter.
  • FIG. 1 Another embodiments are directed to computer program products for administering a thermal therapy to a subject, the thermal treatment being provided by a closed loop system having a heater, a circulating fluid pump, a suction source, and a trans-lumenal catheter configured and sized to be inserted through the male urethra.
  • the catheter including a biosample collection port and channel and an outwardly expandable treatment balloon thereon.
  • the balloon is configured, in operation, to expand while the catheter circulates heated fluid to heat the prostatic urethra via the expandable treatment balloon.
  • the computer program product comprises a computer readable storage medium having computer readable program code embodied in the medium, the computer-readable program code comprising: (a) computer readable program code for controlling the temperature of fluid circulating in the catheter so that the temperature of the fluid entering the catheter to travel to the expandable treatment balloon is between about 40-67°C; (b) computer readable program code for timing the duration of the thermal massage treatment so that the treatment lasts from about 20 minutes to 1 hour; and (c) computer readable program code for activating the suction source to draw a biosample from the prostatic urethra into the catheter.
  • the thermal massage can be described as an internal thermal massage where the treatment balloon repetitively expands and contracts to apply a massage to the prostate.
  • Particular embodiments of the present invention are directed to methods for treating prostatitis.
  • the method comprises: (a) inserting a catheter with a suction port and associated flow channel and at least one expandable treatment balloon thereon into the urethra of a subject, the treatment balloon positioned to extend outwardly about the perimeter of a portion of the catheter; (b) inflating the at least one treatment balloon, wherein, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra; (c) heating a targeted region in the prostatic urethra to a temperature of between about 40-47°C for a desired treatment time of at least 20 minutes thereby administering a thermal therapy to the prostate; and (d) collecting prostatic fluid in the catheter proximate in time to and/or during the treatment.
  • the methods include: (a) inserting a catheter with a suction port and associated flow channel and at least one expandable treatment balloon thereon into the urethra of a subject, the treatment balloon positioned to extend outwardly about the perimeter of a portion of the catheter; (b) inflating the at least one treatment balloon, wherein, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra; (c) heating a targeted region in the prostatic urethra to a temperature of between about 40-67°C for a desired treatment time of at least about 20 minutes thereby administering a thermal therapy to the prostate; and (d) collecting prostatic fluid in the catheter proximate in time and/or during the treatment.
  • Figure 1 is a schematic section view illustrating a catheter with an expandable treatment balloon in position in the prostatic urethra according to embodiments of the present invention.
  • Figure 2 is a block diagram of operations of a method according to embodiments of the present invention.
  • Figure 3 is a block diagram of a method of treating the prostate according to embodiments of the present invention.
  • Figure 4 A is a front view of a catheter according to embodiments of the present invention.
  • Figure 4B is a section view of the catheter of Figure 4A taken about line 4B- 4B in Figure 4A.
  • Figure 4C is a section view of an alternate embodiment of the catheter of Figure 4A similar to the view of Figure 4B.
  • Figure 4D is a section view of yet another alternate embodiment of the catheter of Figure 4 A similar to the view of Figure 4B.
  • Figures 4E and 4F are schematic illustrations of exemplary bioentry port configurations.
  • Figure 5 is a schematic view of the catheter of Figure 4A operably associated with a suction pump source according to embodiments of the present invention.
  • Figure 6A is a front view of a catheter according to alternate embodiments of the present invention.
  • Figure 6B is a section view of the catheter taken about line 6B-6B in Figure 6A.
  • Figure 7A is a front view of an additional embodiment of a catheter according to embodiments of the present invention.
  • Figure 7B is a front view on another embodiment of a catheter according to embodiments of the present invention.
  • Figure 7C is a front view of an alternate configuration of a catheter according to embodiments of the present invention.
  • Figure 7D is a section view of the catheter shown in Figure 7C taken along line A-A according to embodiments of the present invention.
  • Figure 8 is a partial cutaway front view of yet another embodiment of a catheter according the present invention.
  • Figures 9A-9D are partial cutaway front views showing another catheter embodiment illustrating the serial progression of different operative configurations according to embodiments of the present invention.
  • Figure 10 is a schematic illustration of a system according to embodiments of the present invention.
  • Figure 11 is a schematic illustration of a system according to embodiments of the present invention with the catheter in position in the body.
  • Figure 12A is a graph of fluid collected over time by a catheter according to embodiments of the present invention.
  • Figure 12B is a graph of the volume of fluid collected during a time interval of interest by a catheter according to embodiments of the present invention.
  • Figure 13 is a schematic illustration of a set of catheters according to embodiments of the present invention.
  • the present invention provides catheters and related systems, methods, and computer program products that can capture biofluids and/or biosamples in vivo, and/or that may enhance the treatment of certain diseases of the body.
  • the present invention is able to monitor the quality or amount of captured biofluids during or at selected times over the course of a treatment.
  • a catheter may be used both to collect a sample from a region in the body and to apply a dilatation, internal massage, and/or thermal therapy to a targeted region in a cavity or lumen of the subject.
  • the catheters may be configured with suction capability to enhance the collection of the desired sample or facilitate the efficacy of certain treatments.
  • the present invention may be particularly suitable for collecting prostatic fluid samples and/or for treating diseases or conditions of the prostate such as BPH, prostatitis, and/or cancer.
  • the present invention may be particularly suitable for treating chronic prostatitis (such as Type II, HI or IN, and more particularly the Type m or IN).
  • the present invention may also be suitable for treating prostatodynia.
  • embodiments of the present invention will be primarily discussed in relation to the male urethra.
  • other transluminal or transcavity catheter configurations may be used for other lumens or natural body cavities.
  • the catheters of the present invention may be alternately configured and adapted as appropriate for insertion in other natural lumens or body cavities such as, but not limited to, the colon, the uterus, the cervix, the female urethra, the throat, mouth or other respiratory passages, the ear, the nose and the like.
  • Figure 1 illustrates a transluminal or transurethral elongated catheter 10 which may be inserted into the prostatic urethra via the penile meatus and up through the male urethra.
  • the catheter 10 can be a flexible catheter so as to be able to be inserted into position in a manner that reduces the likelihood of discomfort (following or bending to the shape of the urethra during insertion).
  • the catheter 10 includes a bladder anchoring balloon 15 and at least one treatment balloon 20 positioned on an outer perimeter thereof.
  • the treatment balloon 20 is outwardly expandable. In position, the treatment balloon 20 is configured and sized to radially expand to contact localized tissue in the prostatic urethra.
  • the single treatment balloon 20 can be configured as a plurality of circumferentially or axially spaced balloons (not shown).
  • the treatment balloon 20 may be configured as substantially round or oval. The length may be about twice the size of the diameter or width when expanded.
  • the tip of the catheter 10 is shown as linear, but may also have other configurations such as a Coude or Tiemann configuration.
  • the Coude tip may be particularly suitable for some oval treatment balloon configurations (because in the relaxed position the urethra can have an arcuate or oval-like shape (viewed anterior to posterior)).
  • the catheter 10 also includes at least one biosample entry port 25 (shown as a plurality of apertures) formed into the outer wall lO of the catheter.
  • the biosample entry port(s) 25 is in fluid communication with a biosample flow channel 25c disposed internal to the catheter 10 ( Figures 4B, 4C).
  • a suction source 40 can be arranged so as to be in fluid communication with the biosample flow channel 25c to draw in or suction biosamples comprising fluid.
  • the biosample can also include tissue or cell samples.
  • the biosample comprises prostatic fluid collected from the prostatic urethra and/or the membraneous urethra.
  • the biosample entry port 25 may be configured so that, in position in the body, the port or ports 25 reside above the urinary sphincter and below the bladder.
  • the catheter 10 can include a urine drainage port 26 and associated urine drainage channel 26c.
  • the urinary drainage channel 26c can be configured to be separate and in fluid isolation from the biosample flow channel 25c. That is, in position, urine can drain through the catheter 10 via the urine drainage channel 26c while the biosample is suctioned into the catheter biosample flow channel 25c such that each is directed through the catheter without intermingling the two fluids.
  • the collected biosample can be delivered out of the body in a condition so as to be substantially void of urine and in substantially the same concentration with the same constituents as that at its point of entry into the catheter.
  • the term "substantially void of urine” means that the collected specimen contains less than about 40% urine, certain embodiments, the collected specimen contains less than about 10-20% urine. In yet other embodiments, the specimen is collected in a manner such that it is not diluted from its in vivo concentration by more than 1-5%.
  • the bladder-anchoring balloon 15 can be configured to substantially block or plug the urethra at the bladder neck so as to inhibit the entry of urine into the prostatic urethra during collection of the prostatic biosample (not shown).
  • Figure 2 illustrates operations that can be performed according to embodiments of the present invention.
  • An elongated transurethral catheter can be positioned into the prostatic urethra of a subject.
  • the catheter can include a bladder anchoring balloon, at least one biosample entry port disposed axially away from the bladder anchoring balloon, and an axially extending biosample flow channel in fluid communication with the biosample entry port (block 100).
  • the anchoring balloon can be inflated to position the catheter so that the fluid entry port is proximate the prostatic or membraneous urethra of the subject (block 110).
  • a biosample comprising prostatic fluid can be directed from the prostatic and/or membraneous urethra and/or into the biosample entry port and into the biosample flow channel (block 120).
  • the directing step can be carried out by suctioning or drawing the biosample into the catheter (block 121).
  • the at least one biosample entry port can be a plurality of entry ports that are positioned to reside proximate the verumontanum during the collection of the biosample (block 122).
  • the catheter 10 can be configured to deliver a thermal therapy in addition to being configured to suction a biosample.
  • the thermal therapy can be applied to targeted tissue at a temperature of between about 40-85°C (or higher for some applications), and is typically between about 40-67°C.
  • the therapy time can be earned out in desired time increments according to the particular application, typically ranging between about 5 minutes to 90 minutes.
  • the administration of a thermal therapy can enhance the quantity of a biosample specimen that can be collected.
  • suctioning fluid biosamples during the thermal therapy may enhance the efficacy of the treatment.
  • the heat can be supplied by any desired heating source including RF, microwave, laser, ultrasound, conductive heat that can be generated with localized or circulating heated fluid, and the like.
  • the heat can be applied using microwave and RF energy to heat the tissue (which may include a distal heating element) and expanding the treatment balloon a desired distance as it resides in the prostatic urethra to provide the internal thermal therapy.
  • the collection of the biosample can be carried out in a number of ways, such as concurrently with the administration of a thermal therapy.
  • the collector can also be carried out intermittently during the course of the treatment as well as either before and/or after the treatment. In other embodiments, the collection can be performed substantially continuously for a major portion or all of the treatment.
  • Figure 12A illustrates that the flow rate or volume of collected biosample over time can be monitored over the treatment period. This data may indicate when to end the therapy, or what the tissue activity is in the body in the treatment region.
  • Figure 12B illustrates that the biofluid can be collected for analysis. It may be possible to develop a predictive behavior, for example, if a lesser volume is obtained relative to standardized norms (set by the subject or a correlated population), this may indicate that the penetration depth of the treatment is reduced or that the tissue is deficient in liquid.
  • the collected biosample can be analyzed for the presence, absence or elevated or deficient levels of one or more analytes of interest to assess the therapeutic response of the subject to a treatment such as a medicament (whether thermal, pharmaceutical, diet, exercise or other behavioral based regimen) or to provide a diagnosis of a condition.
  • a treatment such as a medicament (whether thermal, pharmaceutical, diet, exercise or other behavioral based regimen) or to provide a diagnosis of a condition.
  • the catheter can be alternatively configured to provide the desired access to the desired tissue.
  • the catheter can also be configured to administer a desired medicament whether pharmaceutical or sterile liquid and the like.
  • the medicaments can include, but are not limited to, one or a mixture of antibiotics, anti-inflammatory medication, antioxidants (such as QUERCETIN), anesthetics or pain relief medications, and sterile water.
  • the catheter 10' does not include a treatment balloon and obtains the biosample without the use of a concurrent internally administered thermal therapy or an internal massage.
  • this embodiment does not preclude the use of external or rectal massages and the like that can be performed during and/or proximate in time to the capturing in vivo of the flowably collected biosample.
  • the heat or thermal therapy is supplied by heating fluid external of the body of the subject and directing it so that it travels captured in the catheter to the treatment balloon.
  • the system and the balloon can be configured to continuously circulate heated fluid to a regulated desired thermal treatment temperature.
  • the catheter can have increased insulation regions located about the shaft below the treatment balloon to insulate the non- targeted tissue as the heated fluid travels to the remote in vivo treatment site.
  • the catheter 10 can be configured to deliver a thermal ablation treatment to a targeted region (shown by the arrows in the lined region in the prostate in Figure 1).
  • thermal ablation refers to exposing the targeted tissue to a temperature that is sufficient to kill the tissue.
  • the thermal ablation is carried out by exposing the targeted tissue to thermocoagulation via circulating hot liquid heated external of the body of the subject and directed to expand the treatment balloon 20 in the targeted treatment region.
  • the tissue is exposed to an elevated temperature that is greater than (or equal to) about 45°C for a predetermined period of time such as about 5-20 minutes or longer.
  • the thermal ablation is directed to treating BPH and the thermal therapy is carried out so that the prostatic tissue is exposed to a temperature of about 60-62°C for a treatment period that is about 20-90 minutes in duration, and more preferably about 45 minutes, h other embodiments, the treatment is directed at prostatitis and the targeted tissue is exposed to elevated temperatures in the range of about 40-47°C (at or below minimal ablation temperatures) for a period of about 20-90 minutes.
  • the prostatitis thermal treatment and/or the BPH thermal ablation therapy can be carried out in a localized treatment region within the prostatic urethra, the treatment region being generally described as including the prostatic urethra below the bladder neck and above the verumontanum of the subject.
  • the treatment region may include the bladder neck or a portion of the bladder neck itself.
  • thermotherapy An example of a thermal treatment system that is configured to circulate heated fluid to administer water induced thermotherapy is identified as the Thermq 7ex® system available from ArgoMed, Inc. located in Cary, North Carolina. See also, U.S. Patent Nos. 5,257,977 and 5,549,559 to Eshel, and co-assigned U.S. Patent Application Serial No. 09/433,952 to Eshel et al, the contents of which are hereby incorporated by reference as if recited in full herein.
  • Figure 3 illustrates a flow chart of operations according to one embodiment of the present invention.
  • a catheter can be inserted into the urethra of a subject.
  • the catheter can include, in serial order from the most distal portion, a bladder anchoring balloon, at least one expandable treatment balloon, and at least one fluid entry port formed into the wall of the catheter.
  • the catheter also includes an axially extending biosample flow path in fluid communication with the fluid entry port(s) disposed internal to the catheter wall (block 200).
  • the bladder-anchoring balloon can be expanded to contact and reside against the bladder neck of the subject to secure and position the catheter in the subject (block 210).
  • Fluid can be heated to a desired temperature (block 220) and directed to travel, captured, through the catheter to the at least one expandable treatment balloon (block 230).
  • the at least one treatment balloon inflates responsive to the step of directing heated fluid, hi position, the inflated balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic uretlira (block 240).
  • the targeted tissue in the prostatic urethra can be heated to a temperature of between about 40-67°C for a desired treatment time of at least about 20 minutes (block 250).
  • a biosample comprising prostatic fluid can be suctioned into the fluid entry port and into the biosample flow path of the catheter (block 260). The sample can be analyzed as noted above.
  • the catheter 10 includes an outer wall lOw, the anchoring balloon 15, the treatment balloon 20, and an elongated shaft 21.
  • the catheter 10 also includes inlet and outlet or exit fluid circulating paths 30i, 30e, respectively, as well as a urinary drainage channel 26c (which can also be used to deliver medicaments therethrough while the catheter 10 is in position in the subject by reversing the direction of flow through the channel).
  • the catheter 10 can also include a collar 10c on its proximal end with four separate fluid flow paths 26c, 25c, 30e, 30i.
  • the collar 10c connects the passageways/lumens or channels of the distal portion of the catheter into the desired flow paths external of the body (shown as comprising flexible conduits on the other side of the collar 10c).
  • the anchoring balloon 15 can be in fluid communication with the treatment balloon 20 such that both are inflatable by the circulating heated fluid.
  • the balloons 15, 20 can be in fluid isolation (and separately inflatable).
  • the upper anchoring balloon 15 can be separately inflatable to allow this balloon 15 to be inflated before the treatment balloon 20. This can reduce the likelihood that the balloon 15 or 20 will be inflated below the desired location (potentially introducing damage to the bladder neck or the upper portion of the prostate urethra) and facilitate proper positioning of the catheter 10 in the prostate relative to the bladder.
  • heated fluid is heated external of the subject, directed into the catheter 10 and circulated in the enclosed fluid paths 30i, 30e in the catheter 10.
  • the fluid is directed through the shaft 21 via the inlet path 30i to the treatment balloon 20 located proximate the desired treatment site, then out of the treatment balloon 20 to the outlet path 30e and out of the subject.
  • the system can be configured to operate with a low volume of liquid.
  • low volume means below about 100 ml, and, in conventional circulating systems can be in the range of about 20-50 ml. In certain particular embodiments, about 20-40 ml of liquid can be circulated at any one time in the catheter.
  • the system itself may be configured to hold an additional quantity, such as about 35 ml or more, in reserve.
  • 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 the balloon integrity be compromised, accidentally rupture, leak, or otherwise become impaired during service.
  • the catheter 10 is preferably flexibly configured so as to be able to bend and flex to follow the shape of the lumen (even those with curvatures) as it is introduced into the lumen until a distal portion of the catheter 10 reaches the desired treatment site. It is also prefened that the catheter 10 is configured such that it can flex to follow the contours of the male urethra while having sufficient rigidity to maintain a sufficiently sized opening in the drainage (preferably the central) lumen 26c to allow urine drainage and or flushing or drug delivery during the initial healing period while in position (even after exposure to the thermal ablation therapy described above).
  • the catheter 10 can be sized with a relatively small cross-sectional area with a thin outer wall lOw so as to be able to be inserted into and extend along a length of the desired lumen to reach the desired treatment site.
  • thin outer wall means a wall having a thickness of about 3 mm or less, and preferably about 2 mm or less.
  • the cross-sectional width of the catheter 10 is typically less than about 10 mm and, more typically, the width or outer diameter of the catheter 10 is about 6-9 mm.
  • the catheter 10 can include only a single internal fluid channel, such as the biosample flow channel 25c or the biosample flow channel 25c, and one or more additional channels. As shown in Figure 4B, for certain applications, the catheter 10 includes at least four separate fluid channels: the biosample flow channel 25c; the circulating inlet and outlet channels 30i, 30e; and the fluid drainage channel 26c. As shown in Figure 4B, the urine drainage channel 26c may be disposed intermediate the circulating inlet and outlet channels 30i, 30e.
  • the biosample entry ports 25 can be circumferentially spaced apart about the outer wall lOw of the catheter and terminate into a common biosample flow channel 25c.
  • the catheter 10 can be configured to include a plurality of separate biosample flow channels 25c, each corresponding to one or more entry ports 25.
  • Figure 4D illustrates that the catheter 10 includes a plurality of elongated channels 125c that are positioned between the inner lumens and the outer wall lOw.
  • the elongated channels 125c can be configured as a plurality of separate axially extending elongated tubular members with relatively small internal diameters that circumferentially span the internal lumen passage(s).
  • each biosample flow channel can be in fluid communication with one or a plurality of entry ports 25.
  • the entry ports 25 can be formed to be axially and/or laterally spaced apart about a selected perimeter portion of the catheter.
  • Figure 4E illustrates that the entry ports can be axially and laterally aligned about the perimeter of the catheter 10 while Figure 4F illustrates that the entry ports 25 can be configured to be offset one from the other. Other configurations can also be employed.
  • a common biosample flow channel 25c is configured to encase the urine drainage channel 26c as well as the circulating inlet and outlet channels 30i, 30e.
  • FIG. 4C illustrates a different fluid lumen and wall configuration.
  • the biosample entry ports 25 are arranged to lie within a baffle structure 29 that radially extends from an inner wall IO J to the outer wall lOw to provide lateral structural reinforcement that can provide resistance to closure during operation.
  • the baffle structure 29 is configured in a "V" or laterally extending triangulated or pointed structure.
  • Other baffle or support configurations can be used to laterally reinforce or bolster an open biosample flow channel 25c during operation.
  • a thicker outer and/or wall lOw, 10w can be used about the region of the biosample ports 25 of the catheter.
  • the apertures or ports 25 may also be formed outside the baffle structure 29 (i.e., outside the "N").
  • the inner fluid lumens (the drainage channel 26c, and the inlet and outlet channels 30i, 30e) can be alternately arranged and configured.
  • the inner fluid channels 26c, 30i, 30e are three substantially equal pie-shaped wedges. These are merely examples of wall and lumen configurations and other configurations may also be used as contemplated by the present invention.
  • FIGs 6 A and 6B illustrate a catheter 10' with at least one slotted port 25 that is in fluid communication with the internal discrete biosample flow channel 25c.
  • the catheter 10' can also include the urinary drainage channel 26c.
  • the discrete biosample flow channel 25c may be defined by an insert or tube positioned in the catheter 10 and formed of a material having increased rigidity over the wall of the catheter lOw.
  • a PNC (polyvinylchloride) insert can be disposed between the inner and outer wall lOw, 10 i. Additional discrete or connected channels 25c can also be employed.
  • Figure 7A illustrates the catheter with biosample collection ports 25 disposed above and below the treatment balloon 20 on the catheter 10".
  • Figure 7B illustrates that the treatment balloon 20' may be configured to extend about portions of the perimeter of the catheter shaft so as to be axially intermittently spaced expandable balloons 20' with biosample ports 25 located at one or more of above, below, and intermediate thereof.
  • Figures 7C and 7D illustrate that the treatment balloon 20" can be configured as radially spaced apart expandable balloon segments 20" and the biosample ports 25 can be located radially spaced apart between the balloon segments 20".
  • the biosample ports 25 may be positioned so as to be axially or laterally interspersed or intermediate the expandable treatment balloons 20', 20".
  • the catheter 10 may also include a region with increased insulation 21i
  • the increased insulation regions 21i can reduce the temperature that non-targeted tissue is exposed to along the fluid flow paths in the catheter 10.
  • the increased insulation regions 21i can extend along the portion or length of the catheter that, in operation, resides below or away from the targeted treatment region in the body (below the sphincter in the male urethra in the prostate application as shown in Figure 1) during the thermal therapy to reduce the likelihood that the non-targeted tissue will be exposed to undue elevated temperatures.
  • the increased insulated regions 21 i have been provided by various means such as configuring the catheter with an extra layer or thickness of a material along the proximal or lower shaft portion.
  • insulation means include a series of circumferentially arranged elongated channels or conduits (either filled with air or other material (and that may be sealed enclosures of same), or which are configured to provide lateral thermal resistance), which encircle the heated circulating fluid passages and provide thermal insulation along the elongated shaft portion of the catheter. Additional description and examples of insulation means and configurations, wall structure configurations, and lumen/channel configurations that may be collapse- resistant during operation are found in U.S. Patent Nos. 5,257,977 and 5,549,559 to Eshel, and co-pending and co-assigned U.S. Provisional Patent Application Serial No. 60/248,109, the contents of which are hereby incorporated by reference as if recited in full herein.
  • the insulation means acts to reduce the heat transferred to non-targeted treatment sites, such as along the penile meatus, urethral mucosa, or urefhral sphincter, during the treatment (such as BPH, prostatitis, or cancer therapies).
  • non-targeted treatment sites such as along the penile meatus, urethral mucosa, or urefhral sphincter, during the treatment (such as BPH, prostatitis, or cancer therapies).
  • the catheter 10, 10', 10" can have an outer wall lOw and an inner wall 10Wi , each having a thickness of between about 1-2 mm formed of a thermoplastic elastomer such as silicone, rubber, plasticized PNC, or other suitable biomedically acceptable elastomeric body.
  • a thermoplastic elastomer such as silicone, rubber, plasticized PNC, or other suitable biomedically acceptable elastomeric body.
  • Figure 8 illustrates another embodiment of the present invention.
  • the catheter 10 can include a sleeve 20s disposed over the treatment balloon 20.
  • the sleeve may also extend to cover the anchoring balloon (not shown).
  • the sleeve 20s can compress the treatment balloon 20 to take on a low profile (held snugly against the shaft) during insertion and removal of the catheter from the body.
  • the sleeve 20s may be configured from flexible thin material that is able to compress the treatment balloon 20 against the shaft of the catheter.
  • the sleeve 20s can be configured so that it is able retain its elasticity after exposure to a thermal treatment so that it can cause the treatment balloon to collapse against the shaft when the circulating fluid is removed in preparation for sliding removal from the body, hi certain embodiments a fluid or media 220 can be disposed intermediate the treatment balloon 20 and the sleeve 20s (shown as the shaded area intermediate same in the figure). This fluid or media 220 can be a medicament that leaches into the body over the course of the treatment.
  • the sleeve can be configured as a porous material (or with drug exit ports) that can allow the internally held media or fluid 220 to exit the sleeve 20s during or after treatment. That is, instead of pre-filling the catheter with the medicament or media 220 during fabrication, the medicament or media 220 can be directed into the catheter and then into the sleeve 20s (via a corresponding flow path) during or after administration of the thermal therapy and then released into the body of the subj ect through the porous membrane.
  • a selected coating can be disposed over the treatment balloon or sleeve such that it can be administered or released in vivo during the treatment.
  • the prostate drainage port(s) 25 and channel(s) 25c can be used to administer medicaments sterile liquids and the like at desired times before, during, or after the treatment.
  • one or more of the elongated channels 125c shown in Figure 4D can be used to direct flowable medicines into the prostatic uretlira.
  • the same or different ones of the elongated channels 125c can be used to aspirate and/or deliver medicaments.
  • the elongated channels 125c can also define or form a part of the insulation means for the increased insulation regions 21i on the catheter.
  • Other medication ports and channels can be formed into the catheter as desired.
  • the catheter 10 can be configured to provide an occlusion or segmented region in the urethra in which to administer a medicament. This segmentation can direct the medicament into the desired region and effectively trap the medicament there so as to inhibit its run-off or exit from the treatment region.
  • the entry ports 25 and associated channels 25c are used to introduce a desired medicament at elevated pressures to the prostate proximate in time to the dilatation and heat treatment.
  • the catheter 10 can include a blocking balloon 320 ( Figures 9A-9D) that is configured to close off the lower portion of the urethra from drainage except for the urinary flow through the catheter. See e.g., U.S. Patent No.
  • the blocking balloon can be configured so that in position it expands to contact the membraneous urethra (up to the sphincter) or the bulbous urethra (down to the sphincter).
  • Figures 9A-9D illustrate a sequence of operations for a catheter having an example of a blocking balloon 320.
  • the blocking balloon 320 is positioned below the prostate drainage ports 25.
  • the blocking balloon 320 is positioned on the catheter 10 such that it is below the anchoring balloon 15
  • Figure 9 A illustrates the configuration of the treatment balloon 20 and the blocking balloon 320 during administration of a thermal therapy (and the anchoring balloon 15 also expanded to hold the catheter 10 in its desired position in the body), h other embodiments, the blocking balloon 320 can also be expanded during the entire or selected portions of the therapy.
  • Figure 9B illustrates the blocking balloon 320 having an expanded configuration. As shown, the blocking balloon 320 can have a lateral expansion width L w that is about equal to or larger than the treatment balloon 20.
  • Figure 9C illustrates that the treatment balloon 20 can be collapsed before the blocking balloon 320.
  • a medicament is directed to flow in the channel 25c and exit the ports 25 at an elevated pressure so that it may have increased penetration depth into the prostate proximate in time to the dilatation and heat treatment.
  • the elevated pressure may be selected so that the medicament is expelled from the port 25 with sufficient force to promote tissue penetration and spraying of proximate tissue.
  • the expulsion pressures may be between about 0.1-7 atm, and can, in particular embodiments, be from about 1-2 arm.
  • Figure 9D illustrates the configuration of the catheter upon insertion or removal with the anchoring balloon 15, the treatment balloon 20, and the blocking balloon 320 all collapsed against the shaft of the catheter.
  • the therapeutic treatment delivered by the thermal system can include an internal massage that is delivered by repetitively outwardly expanding and then contracting the treatment balloon 20 a desired distance. See co- pending and co-assigned U.S. Provisional Application Serial No. 60/308,344, the contents of which are hereby incorporated by reference as if recited in full herein.
  • the system can be configured to provide a relative quick massage cycle (such as about 1-12 cycles or pulses every second) or slower massage cycle (20-60 pulses per minute); the rate and force of the massage can be adjusted during the treatment as will be discussed further below.
  • fluid or air provided at a non-elevated (ambient or body) temperature may be used to perform the massage (or an initial portion of the massage) with or without a thermal therapy to relax the local tissue prior to, after, or concunent with suctioning the biosample from the targeted biosample region.
  • therapeutic agent include medicines, food supplements, or bioactive substances or formulations used to treat diseases or symptoms.
  • the therapeutic agent can be delivered either systemically or locally alone or as an adjunct to the thermal or massage therapy, including over-the-counter or prescription pharmaceutical products, vitamins or food, beta radiation, and the like.
  • FIG. 5 illustrates that the thermal treatment system 50 can be configured as a closed loop circulating fluid system
  • the suction source 40 can also be the fluid circulation pump 55.
  • the biosample flow path 25c can include a length of flexible conduit 25f that extends from the catheter external of the body and engages with the pump mechanism 55.
  • the pump 55 draws or directs the fluid therein to discharge downstream of the pump 55 into a biosample collection chamber or container 25cont to provide the suction force in the biosample flow path 25c. See e.g., U.S. Patent Application 09/433,952 and U.S.
  • Patent 5,549,559 the contents of which are hereby incorporated by reference as if recited in full herein, for descriptions of a suitable closed loop circulating fluid system.
  • Fluid circulating WITTM catheters with expandable treatment balloons are available from ArgoMed, Inc., in Cary, NC.
  • the pressure in the treatment balloon (which conesponds to the pressure in the closed loop system) maybe from about 0.5-4 atm, and typically at least about 0.75-2 atm during at least a portion of the treatment to increase the pulsation force presented to the localized tissue.
  • Figure 10 illustrates one embodiment of a system 50 which can be used to collect and/or suction prostatic fluid from biosample ports 25 and that may, in certain embodiments, also heat fluid that is then directed into the catheter 10 to cause the treatment balloon to expand so as to apply a thermal and/or massage therapy to the localized tissue in the prostatic urethra.
  • the system 50 is a closed loop system includes a fluid circulation pump 55, a pressure monitoring and controlling device 56, a heater 57, a controller 59, and temperature sensors 17i, 17o, all of which are operably associated with the catheter 10.
  • the system can be configured as a low volume system (circulating from between about 10-100 ml of fluid).
  • the circulation and/or the internal massage can be provided by using a peristaltic pump to generate pulsatile fluid flow.
  • a three-roller pump may be configured to operate to provide about 1-12 or 1-20 expansion and contraction pulses per minute in the balloon. This action can be caused by using a pulsatile flow pump having three rollers with between about 200-750 rotations per minute while a two roller pump may be configured to operate with between about 200-500 rotations per minute, each can operate so as to provide a conesponding number of pulses to the treatment balloon.
  • Suitable pump heads are available from Watson Marlow Inc., of Wilmington, MA, and Barnant Co., of Barrington, IL. Of course, other methods for expanding and contracting a treatment balloon or generating the pulsatile flow can also be used as will be appreciated by those of skill in the art. As shown in Figure 5, the biosample flexible conduit 25f may be configured to wrap about the pump head/rollers to provide the suction source or other suction sources such as a stand-alone suction pump or piston may also be used.
  • Figure 11 illustrates the catheter 10 in position in the body and operably associated with an associated operating system 50 according to one embodiment of the present invention similar to that shown in Figure 10.
  • the catheter 10 is configured to collect the biosample, but may not employ a suction source. Rather, gravity, capillary action, or other collecting means may be employed.
  • the entry ports 25 are positioned to reside proximate the verumontanum of the subject where increased prostatic fluids may be more prevalent or easier to collect.
  • the entry ports 25 can be alternatively configured on the catheter 10 depending on the targeted region of interest.
  • the pressure adjustment device 56 may also include a pressure sensor 15s to sense pressure in the system and be configured for automatic pressure adjustment to facilitate consistency between treatments and may also be configured to allow the patient to set certain operating pressures in the balloon 20 and/or system 50. Additional description of pressure adjustment systems and devices can be found in co-pending, co-assigned U.S. Provisional Application Serial No. 60/318,556, the contents of which are hereby incorporated by reference as if recited in full herein.
  • the treatment balloon 10 is configured with an axial length that is selected so that, in position, it resides above the verumontanum of the subject.
  • the catheters 10, 10', 10" may be provided as a kit or set of catheters as shown in Figure 13 with various lengths of treatment balloons 20 with the suction ports 25 positioned thereon.
  • the catheters may be configured in an anay of different treatment balloon 20 sizes and/or lengths to provide a custom fit for the subject (the length of the prostatic urethra will vary subject to subject).
  • a set of catheters can be provided such so as to provide, in about 0.5 cm increments, treatment balloon lengths ranging from about 1 cm to 6 cm such that, in operation, a selected treatment balloon resides above the verumontanum of the subject in the prostatic urethra.
  • the concunent combination of suction with or proximate in time to the administration of one or more of pressure (such as massage therapy or balloon dilatation) and/or heat may provide increased therapeutic responsiveness over conventional treatments or may provide improved sample collection techniques, h other embodiments, as an alternative to thermal treatment, the internal massage can be administered alone by using a low heat or cooled or ambient non-heated medium such as water or other biocompatible substance to cause the treatment balloon to expand and suctioning the prostatic urethra or membraneous urethra.
  • the present invention may be embodied as a method, data or signal processing system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product on a computer-usable storage medium having computer-usable program code means embodied in the medium. Any suitable computer readable medium may be utilized including hard disks, CD-ROMs, optical storage devices, or magnetic storage devices.
  • the computer-usable or computer-readable medium may be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. More specific examples (a nonexhaustive list) of the computer-readable medium include the following: an electrical connection having one or more wires, a portable computer diskette, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, and a portable compact disc read-only memory (CD-ROM).
  • RAM random access memory
  • ROM read-only memory
  • EPROM or Flash memory erasable programmable read-only memory
  • CD-ROM portable compact disc read-only memory
  • the computer-usable or computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via, for instance, optical scanning of the paper or other medium, then compiled, interpreted or otherwise processed in a suitable manner if necessary, and then stored in a computer memory.
  • Computer program code for carrying out operations of the present invention may be written in an object oriented programming language such as Java®, Smalltalk, Python, or C++. However, the computer program code for carrying out operations of the present invention may also be written in conventional procedural programming languages, such as the "C" programming language or even assembly language.
  • the program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer. In the latter scenario, the remote computer may be connected to the user's computer through a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
  • LAN local area network
  • WAN wide area network
  • Internet Service Provider for example, AT&T, MCI, Sprint, EarthLink, MSN, GTE, etc.
  • the present invention may include a controller with a suction operation module and may also include a thermal or massage therapy module being an application program.
  • the module(s) can be a stand-alone module or may also be incorporated into the operating system, the I/O device drivers or other such logical division of the data processing or control system.
  • each block in the flow charts or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s).
  • the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may in fact be executed substantially concunently or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.
  • the internal or in vivo collection capability with or without thermal or internal massage therapy provided by operations of the present invention can be carried out in a non-traumatic, minimally invasive manner.
  • the heat generated during the thermal therapy can result in blood flow redistribution, which, in turn, may result in adhesion molecule difference and/or a difference in expression or prostate remodeling and collection of prostatic fluid or suctioning the fluid during the thermal therapy may enhance the therapeutic efficacy of the treatment.
  • Suctioning fluid from the prostate during a thermal therapy provided by the instant invention may help regulate apoptosis in the prostate that may beneficially influence lower urinary tract symptoms in men with BPH or prostatitis.
  • the therapy may act on the nerve endings in the inflamed prostate that may reduce the pain or improve the quality of life for the subject. Also, this may influence the formation of new blood vessels (angiogenisis) that may be considered a major contributor or of tissue development (particularly in BPH therapies).

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  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Percussion Or Vibration Massage (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne des procédés, des systèmes, et des produits de programme informatique permettant d'obtenir un échantillon in vivo et/ou de traiter un sujet. Ces procédés consistent à positionner un cathéter transurétral allongé dans l'urètre prostatique d'un sujet, le cathéter présentant un ballonnet d'ancrage à la vessie, au moins un port d'entrée de bio-échantillon éloigné de manière axiale du ballonnet d'ancrage à la vessie, et un canal d'écoulement de bio-échantillon s'étendant de manière axiale, en communication fluidique avec le port d'entrée de bio-échantillon, maintenu intérieurement dans le cathéter. Le ballonnet d'ancrage est gonflé pour positionner le cathéter, de sorte que le port d'entrée de fluide se trouve à proximité de l'urètre prostatique du sujet, et que le fluide prostatique est aspiré de l'urètre prostatique jusqu'au port d'entrée de bio-échantillon, et jusqu'au canal d'écoulement de bio-échantillon. Le cathéter peut comprendre un ballonnet de traitement thermique et/ou un ballonnet de dilatation, et l'échantillon aspiré peut être obtenu simultanément, ou pendant, ou à peu près au moment de l'application du traitement. Ce cathéter peut être configuré pour permettre à l'urine de le traverser pour être drainée, lors du traitement/recueillement de l'échantillon, tout en maintenant l'urine isolée de l'échantillon de fluide prostatique recueilli.
PCT/US2002/030354 2001-10-17 2002-09-25 Catheters presentant une capacite d'aspiration, procedes et systemes associes permettant d'obtenir des bio-echantillons in vivo WO2003033045A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2002337679A AU2002337679A1 (en) 2001-10-17 2002-09-25 Catheters with suction capability and related methods and systems for obtaining biosamples in vivo
JP2003535846A JP2005505384A (ja) 2001-10-17 2002-09-25 吸引機能を備えたカテーテル、ならびにインビボで生体試料を入手する関連方法およびシステム
EP02773564A EP1441779A4 (fr) 2001-10-17 2002-09-25 CATHETERS PRESENTANT UNE CAPACITE D ASPIRATION, PROCED ES ET SYSTEMES ASSOCIES PERMETTANT D OBTENIR DES BIO-E CHANTILLONS i IN VIVO /i
US10/827,741 US20050054994A1 (en) 2002-09-25 2004-04-19 Catheters with suction capability and related methods and systems for obtaining biosamples in vivo

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US33002901P 2001-10-17 2001-10-17
US60/330,029 2001-10-17

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WO2003033045A2 true WO2003033045A2 (fr) 2003-04-24
WO2003033045A3 WO2003033045A3 (fr) 2003-08-14

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PCT/US2002/030354 WO2003033045A2 (fr) 2001-10-17 2002-09-25 Catheters presentant une capacite d'aspiration, procedes et systemes associes permettant d'obtenir des bio-echantillons in vivo

Country Status (4)

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EP (1) EP1441779A4 (fr)
JP (1) JP2005505384A (fr)
AU (1) AU2002337679A1 (fr)
WO (1) WO2003033045A2 (fr)

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DE202013001998U1 (de) 2013-02-27 2014-03-17 Ullrich Otto Katheter, insbesondere zur Behandlung von Prostata und/oder Blase, und diesen Katheter enthaltendes Kit
WO2014191549A1 (fr) * 2013-05-29 2014-12-04 Speiser Paul Dispositif de cathéter à ballonnets à trois lumières
EP3175879A1 (fr) * 2015-12-02 2017-06-07 Cook Medical Technologies LLC Dispositifs médicaux de chimiothérapie intrapéritonéale et kits
US9757535B2 (en) 2014-07-16 2017-09-12 Fractyl Laboratories, Inc. Systems, devices and methods for performing medical procedures in the intestine
WO2017174715A1 (fr) * 2016-04-07 2017-10-12 Saxonia R + D GmbH & Co. KG Cathéter urinaire amélioré
WO2017189835A1 (fr) 2016-04-28 2017-11-02 The Regents Of The University Of Michigan Dispositif d'extension de l'intestin mécanotransductif présentant une administration locale de liquides médicalement pertinents
US10232143B2 (en) 2013-11-22 2019-03-19 Fractyl Laboratories, Inc. Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract
US10299857B2 (en) 2013-06-04 2019-05-28 Fractyl Laboratories, Inc. Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract
CN111449688A (zh) * 2020-04-13 2020-07-28 西安交通大学医学院第一附属医院 一种早期胃肠道肿瘤的诊断仪
US10765474B2 (en) 2012-02-27 2020-09-08 Fractyl Laboratories, Inc. Injectate delivery devices, systems and methods
US10869718B2 (en) 2014-07-16 2020-12-22 Fractyl Laboratories, Inc. Methods and systems for treating diabetes and related diseases and disorders
US10959774B2 (en) 2014-03-24 2021-03-30 Fractyl Laboratories, Inc. Injectate delivery devices, systems and methods
US10973561B2 (en) 2012-08-09 2021-04-13 Fractyl Laboratories, Inc. Ablation systems, devices and methods for the treatment of tissue
US10980590B2 (en) 2011-01-19 2021-04-20 Fractyl Laboratories, Inc. Devices and methods for the treatment of tissue
US11185367B2 (en) 2014-07-16 2021-11-30 Fractyl Health, Inc. Methods and systems for treating diabetes and related diseases and disorders
US11246639B2 (en) 2012-10-05 2022-02-15 Fractyl Health, Inc. Methods, systems and devices for performing multiple treatments on a patient
US11439457B2 (en) 2012-07-30 2022-09-13 Fractyl Health, Inc. Electrical energy ablation systems, devices and methods for the treatment of tissue
US11986235B2 (en) 2013-09-12 2024-05-21 Fractyl Health, Inc. Systems, methods and devices for treatment of target tissue
US12303185B2 (en) 2022-08-02 2025-05-20 Fractyl Health, Inc. Electrical energy ablation systems, devices and methods for the treatment of tissue

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US7837670B2 (en) 2005-03-22 2010-11-23 Boston Scientific Scimed, Inc. Methods and devices for delivering therapeutic agents into the prostate gland
WO2006102573A1 (fr) * 2005-03-22 2006-09-28 Boston Scientific Scimed, Inc. Methodes et dispositifs permettant d'administrer des agents therapeutiques dans la prostate
US10980590B2 (en) 2011-01-19 2021-04-20 Fractyl Laboratories, Inc. Devices and methods for the treatment of tissue
US10987149B2 (en) 2011-01-19 2021-04-27 Fractyl Laboratories, Inc. Devices and methods for the treatment of tissue
WO2013010600A1 (fr) * 2011-07-21 2013-01-24 Ullrich Otto Cathéter, notamment cathéter à demeure, pour le traitement de dysfonctionnements et/ou de maladies de la vessie et/ou de la prostate
KR102245697B1 (ko) 2012-02-27 2021-04-28 프랙틸 래브러토리스 인코포레이티드 조직의 치료를 위한 열 절제 시스템，장치 및 방법
US10765474B2 (en) 2012-02-27 2020-09-08 Fractyl Laboratories, Inc. Injectate delivery devices, systems and methods
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AU2020202563B2 (en) * 2012-02-27 2022-03-31 Fractyl Health, Inc. Heat ablation systems, devices and methods for the treatment of tissue
EP2819601A4 (fr) * 2012-02-27 2015-09-02 Fractyl Lab Inc Systèmes, dispositifs et méthodes de thermoablation pour le traitement de tissu
US12201342B2 (en) 2012-02-27 2025-01-21 Fractyl Health, Inc. Heat ablation systems, devices and methods for the treatment of tissue
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US10349998B2 (en) 2012-02-27 2019-07-16 Fractyl Laboratories, Inc. Heat ablation systems, devices and methods for the treatment of tissue
WO2013130655A1 (fr) 2012-02-27 2013-09-06 Fractyl Laboratories, Inc. Systèmes, dispositifs et méthodes de thermoablation pour le traitement de tissu
US11419659B2 (en) 2012-02-27 2022-08-23 Fractyl Health, Inc. Heat ablation systems, devices and methods for the treatment of tissue
US12178502B2 (en) 2012-04-19 2024-12-31 Fractyl Health, Inc. Tissue expansion devices, systems and methods
US11439457B2 (en) 2012-07-30 2022-09-13 Fractyl Health, Inc. Electrical energy ablation systems, devices and methods for the treatment of tissue
US12089887B2 (en) 2012-08-09 2024-09-17 Fractyl Health, Inc. Ablation systems, devices and methods for the treatment of tissue
US10973561B2 (en) 2012-08-09 2021-04-13 Fractyl Laboratories, Inc. Ablation systems, devices and methods for the treatment of tissue
US11246639B2 (en) 2012-10-05 2022-02-15 Fractyl Health, Inc. Methods, systems and devices for performing multiple treatments on a patient
DE202013001998U1 (de) 2013-02-27 2014-03-17 Ullrich Otto Katheter, insbesondere zur Behandlung von Prostata und/oder Blase, und diesen Katheter enthaltendes Kit
WO2014131742A1 (fr) 2013-02-27 2014-09-04 Ullrich Otto Cathéter, en particulier destiné au traitement de la prostate et/ou de la vessie, et kit contenant ce cathéter
DE102013003517A1 (de) 2013-02-27 2014-08-28 Ullrich Otto Katheter, insbesondere zur Behandlung von Prostata und/oder Blase, und diesen Katheter enthaltendes Kit
WO2014191549A1 (fr) * 2013-05-29 2014-12-04 Speiser Paul Dispositif de cathéter à ballonnets à trois lumières
US10004484B2 (en) 2013-05-29 2018-06-26 Paul Speiser Three lumen balloon catheter apparatus
US11311333B2 (en) 2013-06-04 2022-04-26 Fractyl Health, Inc. Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract
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US10335573B2 (en) 2015-12-02 2019-07-02 Cook Medical Technologies Llc Intraperitoneal chemotherapy medical devices, kits, and methods
WO2017174715A1 (fr) * 2016-04-07 2017-10-12 Saxonia R + D GmbH & Co. KG Cathéter urinaire amélioré
US11103675B2 (en) 2016-04-07 2021-08-31 Saxonia R + D GmbH & Co. KG Urinary catheter
EP3448492A4 (fr) * 2016-04-28 2019-11-27 The Regents of The University of Michigan Dispositif d'extension de l'intestin mécanotransductif présentant une administration locale de liquides médicalement pertinents
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Also Published As

Publication number Publication date
AU2002337679A1 (en) 2003-04-28
JP2005505384A (ja) 2005-02-24
EP1441779A4 (fr) 2008-01-16
WO2003033045A3 (fr) 2003-08-14
EP1441779A2 (fr) 2004-08-04

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