Patent Application
20050054994
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.
Conventionally, several types of 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 tile targeted tissue. For example, 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. 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.
One particularly successful 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. In operation, 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. In 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.
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). Generally stated, 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. To enlarge the opening in the prostate urethra (without requiring surgical incision and removal of tissue), 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.
It is believed that chronic prostatitis is one of the most common reasons why men visit urologists, even being characterized as the condition responsible for more outpatient visits than benign prostatic hyperplasia (“BPH”) or prostate cancer. At least one report states that 35-50% of men will be affected by prostatitis at some time in their lives. The treatments conventionally used to treat this condition have been generally problematic; most of the treatments have provided little hope that the condition can be predictably treated in a manner which could successfully alleviate the pain experienced by a large percentage of these individuals. Indeed, prostatitis has been termed “a waste basket of clinical ignorance” because of the lack of knowledge about the basic epidemiology of the disease and also the diagnosis and treatments available for same. See McNaughton Collins et al., How Common is Prostatitis? A National Survey of Physician Visits, Jnl. of Urology, Vol. 159, pp. 1224-1228 (April 1998).
Unlike BPH, which occurs primarily in older men, 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.
There are several classifications or types of prostatitis, each of which may have different characteristics, manifestations, symptoms, or treatment protocols. These are Type I (acute bacterial prostatitis), Type II (chronic bacterial prostatitis), Type III chronic (non-bacterial) prostatitis and/or chronic pelvic pain syndrome (CPPS), and Type IV (asymptomatic inflammatory prostatitis). See Nickel et al., Research Guidelines for Chronic Prostatitis: Consensus Report From the First National Institutes of Health International Prostatitis Collaborative Network, Urology, 54(2), pp. 229-233, 230 (1999).
The Type III prostatitis class (non-bacterial chronic prostatitis) is generally associated with urogenital pain in the absence of uropathogenic bacteria detected by standard microbiological methodology. See Nickel et al., Research Guidelines for Chronic, supra, p. 230. Type III prostatitis may be further defined as IIIA (inflammatory) or IIIB (noninflammatory). The IIIA 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 IIIB 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).
Only a small number of reported prostatitis cases are believed to be of the Type I or acute bacterial type, while the remaining classes of chronic prostatitis may affect an estimated 30 million men in the United States. In any event, as noted above, one of the primary symptoms of prostatitis is a chronic urogenital pain that can negatively impact the quality of life of individuals experiencing this condition. This pain may occur with urination, ejaculation, or in other urogential manifestations. It has been stated that the impact on the quality of life may be similar to those patients suffering unstable angina, a recent myocardial infarct, or active Crohn's disease. As such, chronic prostatitis is a major health care issue. See J. Curtis Nickel, Prostatitis: Myth and Realities, Urology 51 (3), pp. 362-366 (1998).
Recently proposed treatments for prostatitis include internally massaging the prostate during the application of thermal treatment. See co-pending and co-assigned Provisional U.S. Patent Application Ser. No. 60/308,344, the contents of which are hereby incorporated by reference as if recited in full herein.
Notwithstanding the above, there remains a need to provide improved methods and devices for treating diseases of the urethra or prostate including one or more of BPH, chronic prostatitis, and cancer.
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.
In certain embodiments, the catheter can be configured to administer a thermal therapy to the targeted region. In particular embodiments, the thermal therapy can be applied with an internal massage. In other embodiments, 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.
In embodiments for treating diseases of the prostate, 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. In addition, 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.
In certain embodiments, the thermal treatment period can extend from about 5 min to about 90 min (or longer). In particular embodiments, 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).
In addition, 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. In addition, 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.
In addition, 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.
In particular embodiments, 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. As such, 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; (e) inflating the at least one treatment balloon responsive to the directing step, wherein, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra; (f) 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; and (g) drawing a biosample comprising prostatic fluid into the fluid entry port and into the biosample flow path of the catheter.
In particular embodiments, 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.
In particular embodiments, 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.
Similarly, 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. In operation, 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.
Other embodiments are directed at systems for collecting a prostatic fluid specimen in vivo in a subject and/or facilitating the administration of a treatment to a subject. 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. In operation, 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.
In particular embodiments, the pump can be a pulsating pump configured to circulate the fluid in a pulsating flow. In addition, 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.
In other embodiments, 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.
Other 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. In particular embodiments, 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.
Other particular embodiments are directed to methods for treating BPH. 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.
The foregoing and other objects and aspects of the present invention are explained in detail in the specification set forth below.
The present invention will now be described more fully hereinafter with reference to the accompanying figures, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Like numbers refer to like elements throughout. In the figures, certain components, features, or layers may be exaggerated for clarity. In the block diagrams or flow charts, broken lines indicate optional features or steps.
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. In other embodiments, 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. As examples, 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. For prostatitis applications, the present invention may be particularly suitable for treating chronic prostatitis (such as Type II, III or IV, and more particularly the Type III or IV). The present invention may also be suitable for treating prostatodynia. Thus, for ease of discussion, embodiments of the present invention will be primarily discussed in relation to the male urethra. However, other transluminal or transcavity catheter configurations may be used for other lumens or natural body cavities. As such, 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.
In the embodiment shown in
The catheter 10 also includes at least one biosample entry port 25 (shown as a plurality of apertures) formed into the outer wall 10w 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 (
Still referring to
In other embodiments, 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).
Referring again to
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. For example, 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.
Of course, with or without the use of a thermal therapy, 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. Thus, 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.
For example, as shown in
In certain embodiments, 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. In these embodiments, the system and the balloon can be configured to continuously circulate heated fluid to a regulated desired thermal treatment temperature. As such, 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.
In particular embodiments, 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
In certain embodiments, 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. In 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. Alternatively, the treatment region may include the bladder neck or a portion of the bladder neck itself.
An example of a thermal treatment system that is configured to circulate heated fluid to administer water induced thermotherapy is identified as the Thermoflex® system available from ArgoMed, Inc. located in Cary, N.C. See also, U.S. Pat. Nos. 5,257,977 and 5,549,559 to Eshel, and co-assigned U.S. patent application Ser. No. 09/433,952 to Eshel et al, the contents of which are hereby incorporated by reference as if recited in full herein.
Referring to
The anchoring balloon 15 can be in fluid communication with the treatment balloon 20 such that both are inflatable by the circulating heated fluid. Alternatively, 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.
Turning to
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 preferred 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 10w so as to be able to be inserted into and extend along a length of the desired lumen to reach the desired treatment site. As used herein, the term “thin outer wall” means a wall having a thickness of about 3 mm or less, and preferably about 2 mm or less. For prostate applications, the cross-sectional width of the catheter 10 is typically less than about 100 mm and, more typically, the width or outer diameter of the catheter 10 is about 6-9 mm.
Referring to
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
Alternatively, 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. For example,
In particular embodiments, as shown in
The catheter 10 may also include a region with increased insulation 21i (
The increased insulated regions 21i 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. Other 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. Pat. Nos. 5,257,977 and 5,549,559 to Eshel, and co-pending and co-assigned U.S. Provisional Patent Application Ser. No. 60/248,109, the contents of which are hereby incorporated by reference as if recited in full herein.
In any event, as the heated fluid travels through the fluid circulating passages, the insulation means acts to reduce the heat transferred to non-targeted treatment sites, such as along the penile meatus, urethral mucosa, or urethral sphincter, during the treatment (such as BPH, prostatitis, or cancer therapies).
In certain embodiments, the catheter 10, 10′, 10″ can have an outer wall 10w 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 PVC, or other suitable biomedically acceptable elastomeric body.
As shown by the dotted shading on the sleeve 20s, 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 subject through the porous membrane.
Alternatively, 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. For additional descriptions of suitable sleeves, materials, and media, see co-pending and co-assigned U.S. Provisional Patent Application Ser. No. 60/288,774, the contents of which are hereby incorporated by reference as if recited in full herein.
In other embodiments, 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. For example, one or more of the elongated channels 125c shown in
In certain embodiments, 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. In particular embodiments, 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. As such, the catheter 10 can include a blocking balloon 320 (
In certain embodiments, 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 Ser. No. 60/308,344, the contents of which are hereby incorporated by reference as if recited in full herein. In certain embodiments, 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.
In addition, 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 concurrent with suctioning the biosample from the targeted biosample region.
The terms “medicament” and “therapeutic agent” include medicines, food supplements, or bioactive substances or formulations used to treat diseases or symptoms. For diseases or conditions of the prostate such as cancer, BPH, and prostatitis or symptoms associated therewith, 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.
In certain embodiments, 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 corresponding number of pulses to the treatment balloon. Suitable pump heads are available from Watson Marlow Inc., of Wilmington, Mass., and Barnant Co., of Barrington, Ill. 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
In
As shown in
The concurrent 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. In 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.
As will be appreciated by one of skill in the art, 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). Note that 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).
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.
The flowcharts and block diagrams of certain of the figures herein illustrate the architecture, functionality, and operation of possible implementations of suction collection or therapy means according to the present invention. In this regard, 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). It should also be noted that in some alternative implementations, 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 concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.
Thus, it will also be understood that one or more blocks of the block diagrams and combinations of blocks in block diagram figures can be implemented or directed to be carried out by computer program instructions. These computer program instructions may be loaded onto a computer or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified in the flowchart block or blocks. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus or associated hardware equipment to function in a particular manner diagrams.
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. In certain embodiments, 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. Further 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).
The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. In the claims, means-plus-function clauses, where used, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.
| Number | Date | Country | Kind |
|---|---|---|---|
| PCT/US02/30354 | Sep 2002 | WO | international |
This application claims priority from U.S. Provisional Application Serial No. 60/330,029, filed Oct. 17, 2001, and PCT Application Serial No. PCT/JUS02/30354, filed Sep. 25, 2002, the contents of which are hereby incorporated by reference as if recited in full herein.
