US20170065160A1 - Method of removing an inflated implant from a bladder - Google Patents

Abstract

An inflated implant, such as an attenuation device, previously implanted in a urinary bladder can later be removed according to a number of different methods. Preferably, removal is accomplished transurethrally. In one embodiment, removal is accomplished by reducing the inflated implant from an enlarged profile to a reduced profile so that it may be withdrawn transurethrally by a removal system. The removal system can be configured differently depending upon whether reduction from the enlarged profile to the reduced profile is accomplished by deflation, compression, and/or other ways.

Description

• This application is a continuation of U.S. patent application Ser. No. 14/512,228, filed Oct. 10, 2014, which is a continuation of U.S. patent application Ser. No. 13/660,814, filed Oct. 25, 2012, now U.S. Pat. No. 8,858,460, which is a continuation of U.S. patent application Ser. No. 12/343,120, filed Dec. 23, 2008, now U.S. Pat. No. 8,298,132, which is a divisional of U.S. patent application Ser. No. 10/391,448 filed Mar. 17, 2003, now U.S. Pat. No. 7,470,228, which is a continuation of U.S. patent application Ser. No. 10/391,446, filed Mar. 17, 2003, now U.S. Pat. No. 6,976,950, which claims priority to U.S. Provisional Patent Appl. No. 60/415,949, filed Oct. 3, 2002, U.S. patent application Ser. No. 10/391,446 is also a continuation-in-part of U.S. patent application Ser. No. 09/723,309 filed on Nov. 27, 2000, now U.S. Pat. No. 6,682,473, which claims priority to U.S. Provisional Patent Appl. No. 60/197,095, filed Apr. 14, 2000; the disclosures of the aforementioned applications are hereby incorporated in their entirety herein by reference. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57.
BACKGROUND
• Field of the Invention
• The present invention relates generally to methods and apparatus for attenuating and/or baffling transient pressure waves in relatively incompressible materials in organs of the body, including, but not limited to the following systems of the human body: cardiovascular, pulmonary, renal/urological, gastrointestinal, hepatic/biliary, gynecological, central nervous, musculoskeletal, otorhinolaryngological and ophthalmic.
• In one particular aspect, the present invention relates generally to the field of urology and gynecology, and in particular to the treatment of disorders of the urinary tract caused by sudden fluctuations of intravesical pressure. More specifically, in this aspect of the present invention, methods and devices are provided for the diagnosis and treatment of urinary disorders such as incontinence, urgency, frequency, interstitial cystitis, irritable bladder syndrome and neurogenic bladders. In addition, delivery and removal systems are also discussed.
• Description of the Related Art
• Pressure waves are known to propagate through incompressible fluids in various organs of the body. These pressure waves may be caused by a number of events including events within the body, such as a beating heart, breathing in the lungs, peristalsis actions in the GI tract, movement of the muscles of the body, or events such as coughing, laughing, external trauma to the body, and movement of the body relative to gravity. As the elasticity of the surrounding tissues and organs, sometimes referred to as compliance, decreases, the propagation of these pressure waves increases. These pressure waves have many undesirable effects ranging from discomfort, to stress on the organs and tissue, to fluid leakage such as urinary incontinence, to renal failure, stroke, heart attack and blindness.
• Pressure accumulators and wave diffusers are types of devices that can modulate pressure waves in various nonanalogous settings. Accumulator technology is well known and used in hydraulic systems in aircraft, manufacturing equipment, and water supply and distribution since the 1940s. Common types of accumulators include bladder accumulators, piston accumulators, non-separator (air over fluid), and weight loaded type accumulators.
• Wave diffusers also affect the transmission of pressure waves in incompressible systems in various settings. The function of such diffusers is to interrupt the progress of a pressure wave and distribute the energy of the wave in so many directions so as to destroy the integrity of a uniform wavefront and its resultant effects. Wave diffusers may be used to protect a specified area from the impact of a wavefront.
• Urinary tract disorders are a widespread problem in the United States and throughout the world, affecting people of all ages both physiologically and psychologically. Urinary tract disorders have a number of causes including birth defects, disease, injury, aging, and urinary tract infection.
• In light of the foregoing, a number of attempts have been made to combat these disorders. One such attempt involves the use of an indwelling catheter connected to a collection bag with a clamping device on the catheter. Indwelling catheters, however, have a number of drawbacks. For instance, there is an infection risk associated with indwelling catheters, which provide a direct passage for bacteria or other microorganisms into the bladder. Thus, indwelling catheters can only be used for relatively short-term situations. In addition, indwelling catheters and associated collection bags are not cosmetically appealing to most patients.
• An attempt at solving urinary incontinence involves the use of prosthetic urethral valves. One such prior art valve utilizes an inflatable cuff that is inserted around the outside of the urethra. The urethral valves of the prior art also have numerous disadvantages. One disadvantage of these valves is that they typically require surgery for installation, and some prior art valves must be operated externally and are therefore dependent on manual intervention.
• The use of intra-urethral valves is also known. Typical intra-urethral valves of the prior art also generally require manual intervention. Another problem associated with prior art intra-urethral valves is that the valves may be displaced into the bladder or expelled from the urethra. There is also an infection risk associated with many such valves since they often extend into the meatus and/or have portions of the device external to the urethra providing a passage for microorganisms into the bladder.
• Electrical stimulation therapy including rectal, intra-vaginal and external has been attempted to tone the muscles and stimulate nerves supporting the bladder and urethra. This therapy requires lengthy and numerous treatments, and any benefits derived from the therapy typically diminish when the treatments are stopped.
• Current surgical incontinence procedures typically focus on the augmentation of urethral flow resistance. Prior art surgical interventions include bladder neck suspensions and bulk (collagen) injections. Although these procedures can be clinically effective with certain patients, problems include widely variable clinical outcomes, relative high costs to perform, potential complications related to surgery, and any effects may be short lived.
• Drug therapy exists for a number of urinary tract conditions, including overactive bladder. These drugs include oral medications (systemic) and drugs delivered directly into the bladder. These drugs typically suffer from side effects, lack of effectiveness and high morbidity. Oral medications typically do not allow immediate relief of symptoms and include side effects such as dry mouth and constipation. Drugs delivered directly into the bladder often require continuous or intermittent catheterization for introduction of the therapeutic agents at the clinically appropriate time.
• The intent of the treatment methods described to date either focus on the augmentation of urethral flow resistance, the temporary stoppage or absorption of all urethral flow, or relaxing the detrusor muscles to minimize unwanted contractions. The disadvantages and limitations of the prior art treatments are numerous and include:
• • an excessively high level of patient interaction is typically required to operate and/or maintain the devices, especially for elderly patients and for physically or mentally challenged patients;
  • limited clinical efficacy;
  • restricted urine outflow;
  • patient discomfort and side effects;
  • urethral and bladder infections related to the devices used; and relatively expensive when compared to non-clinical solutions (diapers, pads, etc.).
• These prior art approaches do not address the reduction in dynamic compliance which results in increased intravesical bladder pressure.
SUMMARY
• There is provided in accordance with one aspect of the present invention, a device for treating symptoms of a urinary tract dysfunction, comprising a compressible attenuation device having an expanded volume within the range of from about 1 cc to about 400 cc, and a valve for permitting filling of the attenuation device through a delivery system.
• In accordance with another aspect of the present invention, there is provided a device for treating symptoms of a urinary tract dysfunction, comprising a compressible attenuation device having an expanded volume within the range of from about 1 cc to about 400 cc, and a valve having a first membrane and a second membrane with a flow passage therebetween for filling the attenuation device.
• In accordance with another aspect of the present invention, there is provided a method of treating a patient after a radical prostatectomy, comprising the step of attenuating an increase in pressure within the bladder by reversibly reducing the volume of the attenuation device in response to the pressure.
• An inflated implant, such as an attenuation device, previously implanted in a urinary bladder can later be removed according to a number of different methods. Preferably, removal is accomplished transurethrally. In one embodiment, removal is accomplished by reducing the inflated implant from an enlarged profile to a reduced profile so that it may be withdrawn transurethrally by a removal system. The removal system can be configured differently depending upon whether reduction from the enlarged profile to the reduced profile is accomplished by deflation, compression, and/or other ways.
• Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates maximum urethral pressure against intravesical pressure during normal voiding.
• FIG. 2 illustrates the intravesical pressure exceeding the maximum urethral pressure in a noncompliant bladder.
• FIG. 3 illustrates an intravesical pressure spike exceeding the maximum urethral pressure during stress incontinence.
• FIG. 4A illustrates the relationship between intravesical pressure and detrusor pressure during cough-induced urgency or frequency.
• FIG. 4B illustrates the relationship between intravesical pressure and detrusor pressure during non-cough-induced urgency or frequency.
• FIG. 5 is a schematic top plan view of an inflatable attenuation device in accordance with one aspect of the invention.
• FIG. 5A is a side elevational cross-section through the attenuation device ofFIG. 5.
• FIG. 6 is a side elevational schematic view of a delivery system for deploying an attenuation device in accordance with one aspect of the present invention.
• FIG. 6A is a side elevational schematic view of one embodiment of the present invention.
• FIG. 6B is a cross-section through theline6B-6B inFIG. 6.
• FIG. 7A is a fragmentary schematic view of the filling tube of a delivery system engaged within the valve of an attenuation device.
• FIG. 7B is a fragmentary schematic view as inFIG. 7A, with the filling tube proximally retracted from the valve.
• FIGS. 8A-8E schematically illustrate different valve constructions for an inflatable attenuation device in accordance with the present invention.
• FIG. 9 is a schematic representation of the delivery system ofFIG. 6, transurethrally positioned within the bladder.
• FIG. 10 is a schematic illustration as inFIG. 9, with the attenuation device inflated.
• FIG. 11 is a schematic view of one embodiment of a delivery system in accordance with the present invention, transurethrally positioned within the bladder.
• FIG. 11A is a cross-section through one embodiment of the delivery system ofFIG. 11.
• FIG. 12 is a side elevational schematic view of an attenuation device removal system in accordance with one aspect of the present invention.
• FIG. 13 is a schematic view of a toroidal shaped attenuation device accordance with one embodiment of the present invention.
• FIG. 13A is a side elevational cross-section view through one embodiment of the attenuation device ofFIG. 13.
• FIG. 14 is a schematic view of a toroidal shaped attenuation device as inFIG. 13, with an integral baffle therein.
• FIG. 14A is a side elevational cross-section view through one embodiment of the attenuation device ofFIG. 14.
• FIG. 15 is a schematic illustration of the attenuation device disrupting the unitary progression of a pressure wavefront.
• FIGS. 16A-D are schematic representations of a variety of inflatable attenuation devices in accordance with the present invention.
• FIG. 17A is a side elevational schematic view of a bellows-type mechanically assisted attenuation device in an expanded configuration.
• FIG. 17B is a side elevational schematic view of the attenuation device ofFIG. 17A, in a compressed configuration attenuating a pressure spike.
• FIG. 18 is a side elevational schematic view of a self-expanding graft type mechanically assisted attenuation device.
• FIG. 19A is a side elevational schematic view of a multiple chamber attenuation device in accordance with a further aspect of the present invention.
• FIG. 19B is a schematic illustration of the multiple chamber attenuation device ofFIG. 19A, in a deployed orientation to ensure retention within the bladder.
• FIG. 20 is a side elevational schematic view of an inflatable balloon-type attenuation device, having a locatable balloon valve thereon.
• FIG. 21 is a schematic perspective view of the attenuation device ofFIG. 20, aligned with the distal end of a delivery or removal system.
• FIG. 22 is a fragmentary cross-sectional view through the distal end of a delivery or removal system, and the proximal end of the valve on an attenuation device, illustrating the valve in a filling or draining orientation.
• FIG. 23 is a fragmentary cross-section as inFIG. 22, showing the valve in a sealed orientation.
• FIG. 24 is a schematic cross-section through a bladder, showing an attenuation device therein, having an attached, external tether.
• FIG. 25 is a schematic cross-section through a bladder, showing a two-component attenuation device in which a primary compressible component is positioned within the bladder and a secondary inflatable component is positioned within the urethra.
• FIG. 25A is a cross-sectional schematic view as inFIG. 25, illustrating the compression of the primary attenuation device in response to elevated abdominal pressure, and the corresponding expansion of the secondary inflatable component.
• FIG. 25B is an enlarged fragmentary schematic view of the inflatable component inFIG. 25A.
• FIG. 25C is a pressure curve showing the intravesical pressure compared to the secondary balloon pressure.
• FIG. 26 illustrates the effect on intravesical pressure of the presence of an implanted attenuation device in accordance with the present invention.
• FIG. 27 is a schematic cross-sectional view through a bladder, showing an attenuation device anchored to the bladder wall.
• FIG. 28 is a schematic cross-sectional view showing a bladder, and the transurethral placement of a dynamic compliancy measurement catheter in accordance with the present invention.
• FIG. 29 is a schematic cross-sectional view through a vessel, illustrating a tubular attenuation device therein.
• FIG. 30A is a schematic cross-section of a left atrial appendage of the heart, having an attenuation device positioned therein.
• FIG. 30B is a schematic cross-section as in30A, showing a bellows-type attenuation device positioned in the left atrial appendage.
• FIG. 31 is a schematic cross-section of a tubular attenuation device positioned within the colon.
• FIG. 32A is a schematic top plan view of an inflatable attenuation device with a duckbill valve design.
• FIG. 32B is a close-up view of the duckbill valve inFIG. 32A.
• FIG. 33A is a schematic top plan view of an inflatable attenuation device with a ring valve design.
• FIG. 33B is a schematic top plan view of an inflatable attenuation device with a fill/plug design.
• FIG. 33C is a schematic top plan view of an inflatable attenuation device with a dome valve design.
• FIG. 34A is an elevated side view of one embodiment of a delivery system for the attenuation device in accordance with one aspect of the present invention.
• FIG. 34B is an elevated side view of one embodiment of a delivery system for the attenuation device with the attenuation device exposed and ejected.
• FIG. 35A is an elevated side view of one embodiment of a delivery system for the attenuation device in accordance with one aspect of the present invention.
• FIG. 35B is an elevated side view of the inflatable attenuation device inFIG. 35A with the sheath slid proximally and the attenuation device exposed.
• FIG. 36 is a schematic top plan view of an inflatable attenuation device with a valve that prevents the influx and/or efflux of media to/from the attenuation device.
• FIG. 37 is a cross-section through the line288-288 inFIG. 36.
• FIG. 38 is a schematic top plan view of a valve with two duckbill structures that prevent the flow of media in both directions.
• FIGS. 39A-D presents graphs of attenuation/pressure reduction vs. time for various attenuation device air volumes.
• FIGS. 40A and 40B illustrate the connective and elastic tissues in the submucosal layer of the bladder.
• FIG. 41 shows a typical cystometrogram.
• FIGS. 42 and 43 provide side elevational cross-sectional views of a partially collapsed bladder.
• FIGS. 44A-D shows pressure vs. time curves generated by a bench top bladder simulator.
• FIG. 45 is a schematic view of one embodiment of an accumulator.
• FIG. 46 is a schematic view of a simple accumulator.
• FIG. 47A is a schematic cross-sectional view through one embodiment of an implantable self-inflating attenuation device.
• FIG. 47B is a schematic cross-sectional view through one embodiment of an implantable self-inflating attenuation device.
• FIG. 47C is a schematic cross-sectional view through one embodiment of an implantable self-inflating attenuation device.
• FIG. 48A is side elevational schematic view of a delivery system for deploying an implantable self-inflating attenuation device in accordance with one aspect of the present invention.
• FIG. 48B is a cross-section through the line442-442 inFIG. 48A.
• FIG. 48C is a schematic cross-sectional view through one embodiment of an implantable self-inflating attenuation device.
• FIG. 48D is an elevated schematic view of a delivery system for deploying an implantable self-inflating attenuation device in accordance with one aspect of the present invention.
• FIG. 49 is a schematic representation of an attenuation device with high vapor pressure gases and/or fluids in accordance with one aspect of the present invention.
DETAILED DESCRIPTION
• Embodiments of the present invention are directed to methods and apparatus for measuring and/or attenuating and/or baffling transient pressure waves in relatively incompressible materials in organs of the body. Illustrative embodiments of the present invention discussed below relate generally to the fields of urology and gynecology, and in particular to the treatment of disorders of the urinary tract exacerbated by sudden fluctuations in intravesical pressure. However, as will be readily understood by those skilled in the art, and as described below, the present invention is not limited to the fields of urology and gynecology and methods and apparatus of embodiments of the present invention may be used in other organs of the body as well to attenuate and/or baffle pressure transients or reversibly occupy intraorgan space.
• Certain embodiments of the present invention dampen transient intravesical pressure including pressure spikes experienced by the urinary tract. During a high frequency transient pressure event, the bladder becomes a relatively non-compliant environment due to a number of factors including the pelvic skeletal structure, the compressive loads of contracting tissues bounding the bladder or the decreased compliance of the musculature, nerve or connective tissue of the bladder. The factors contributing to the reduced compliance of the bladder are aging, anatomic abnormalities or trauma to the structures of the pelvis and abdomen.
• Urine is primarily composed of water and is virtually incompressible in the typical pressure ranges present within the human bladder. The relationship between the maximum urethral pressure and the intravesical pressure for normal voiding of the bladder is well defined. With reference toFIG. 1, relaxation of the urethra occurs before the detrusor muscle contracts to cause theintravesical pressure320 to exceed theurethral pressure322 during normal voiding.
• The bladder serves two mechanical functions: 1) low-pressure storage and 2) high-pressure voiding. During the storage or filling phase, the bladder receives an influx of urine from the kidneys. Compliance of the bladder is defined as the ratio of the change in volume to the change in pressure, and the static compliance of the bladder is measured during a typical urodynamic evaluation. The static compliance index is measured by filling the bladder to cystometric capacity and allowing the pressures to equilibrate for a time period of approximately sixty seconds. The static compliance index is calculated by dividing the bladder capacity by the Detrusor pressure at the end of filling. A normal bladder will typically exhibit static compliance between 15 and 30 ml/cm H₂O. A low static compliance bladder typically will have a compliance index of less than 10 ml/cm H₂O. With reference toFIG. 2 which illustrates different pressures for a non-compliant bladder, a low static compliance bladder typically is poorly distensible and has a high end-filling pressure. Theintravesical pressure320 must increase to higher levels to exceed the maximumurethral pressure324. The steady state compliance of the bladder is used to diagnose patients with naturopathic problems such as damage to the lower motor neurons, upper motor neurons, or multiple sclerosis. In addition, the steady state compliance of the bladder is also used, in some cases, to attempt to diagnose problem of incontinence, including urgency, frequency and cystitis.
• In general, intravesical pressure spikes result from volumetric tissue displacement in response to gravity, muscular activity or rapid acceleration. The lack of compliance of the bladder and the urine contained in the bladder with respect to events of high frequency, result in minimal fluidic pressure attenuation of the higher frequency pressure wave(s) and results in high intravesical pressures that are directly transmitted to the bladder neck and urethra, which may or may not cause detrusor contractions. Under these conditions, the urethra may act as a volumetric pressure relief mechanism allowing a proportional volume of fluid to escape the bladder, to lower the intravesical pressure to a tolerable level. The urethra has a maximum urethral pressure value, and when the intravesical pressure exceeds the maximum urethral pressure, fluid will escape the bladder. Under these conditions, nerve receptors in the bladder and/or bladder neck and/or trigone trigger a detrusor contraction that may lead to matriculation (frequency) or may subside without matriculation (urgency) or may lead to the intravesical pressure exceeding the maximum urethral pressure resulting in fluid escaping the bladder (incontinence). Under these conditions, waves hitting and/or expanding the bladder wall, may cause a patient with cystitis to exhibit significant pain.
• Incontinence is common in males who have undergone radical prostatectomy, particularly where the sphincter has been compromised. In these patients, attenuation in the bladder reduces the intravesical peak pressures, resulting in less urine leakage. The attenuation requirements in these patients can include short duration pressure changes—such as, for example, 50 to 400 ms—and long duration pressure changes—such as, for example, greater than 500 ms—depending on the magnitude of damage to the urinary sphincter.
• The inventors of the present application have recognized that for the vast majority of patients suffering from problems of urinary tract disorders such as frequency, urgency, stress and urge incontinence and cystitis, the cause and/or contributor to the bladder dysfunction is a reduction of overall dynamic bladder compliance rather than steady state bladder compliance. These patients may often have bladders that are compliant in steady state conditions, but have become non dynamically compliant when subjected to external pressure events having a short duration of, for example, less than 5 seconds or in some cases less than 2 seconds or even less than 0.5 seconds. Reduction in dynamic compliance of the bladder is often caused by some of the same conditions as reduction of steady state compliance including aging, use, distention, childbirth and trauma. The anatomical structure of the bladder in relation to the diaphragm, stomach, and uterus (for women) causes external pressure to be exerted on the bladder during talking, walking, laughing, sitting, moving, turning, and rolling over.
• The relationship betweenintravesical pressure320 and the maximumurethral pressure324 for a patient suffering from stress incontinence due to lack of dynamic compliance in the bladder is illustrated inFIG. 3. When the patient coughs (or some other stress event occurs), if the bladder does not have sufficient dynamic compliance in that frequency range aspike326 will occur in the intravesical pressure. Intravesical pressure spikes in excess of 120 cm H₂O have been urodynamically recorded during coughing, jumping, laughing or sneezing. When the intravesical pressure exceeds the maximum urethral pressure value, leakage occurs. In order to retain urine during an intravesical pressure spike, the urinary retention resistance of the continent individual must exceed the pressure spike. Urinary retention resistance can be simplified as the sum total of the outflow resistance contributions of the urethra, bladder neck and meatus. In female patients, it is generally believed that the largest resistance component is provided by the urethra. One measure of urinary resistance is the urodynamic measurement of urethral leak pressure. The incontinent individual typically has a urethral leak pressure less than 80 cm H₂O. The decline of adequate urinary retention resistance has been attributed to a number of factors including reduced blood flow in the pelvic area, decreased tissue elasticity, neurological disorders, deterioration of urethral muscle tone and tissue trauma.
• In practice, the urethral leak point pressure is determined by filling the bladder with a known amount of fluid and measuring the intravesical and abdominal pressures when there is a visible leak from the urethra while the patient is “bearing-down” (valsalva). With an attenuation device in the bladder, the measured intravesical leak point pressure typically increases due to the adsorption of some the abdominal energy by the attenuation device. In this case, the patient has to push harder to achieve the same intravesical pressure. Since the abdominal muscles and muscles surrounding the urethra both contract simultaneously during a valsalva maneuver, the measured intravesical leak point pressure and urethral resistance increases when the attenuation device is in the bladder.
• Urinary disorders, such as urgency, frequency, otherwise known as overactive bladder, and interstitial cystitis are caused or exacerbated when rapid pressure increases or rapid volume increases or other irritable conditions within the bladder cause motor neurons to send signals to the brain to begin the cascade of events necessary for urination. External pressure exerted on the bladder may result in a detrusor contraction that may result in urgency, frequency or incontinence. SeeFIGS. 4A (cough-induced urgency/frequency) and4B (non-cough-induced urgency/frequency). With reference toFIG. 4A, acoughing event328 induces increasedintravesical pressure320 which results in increaseddetrusor pressure330. An increase in thedetrusor pressure330 generally is associated with increased urgency, frequency, or incontinence. Urinary disorders such as interstitial cystitis or irritable bladder conditions are a chronic inflammatory condition of the bladder wall, which includes symptoms of urgency and/or frequency in addition to pain. Therefore, the problem of a pressure spike in the functionally noncompliant bladder can be further exacerbated by a nearly simultaneous contraction of the bladder and a relaxation of the urethra.
• Certain embodiments of the present invention provide for methods and devices for measuring and reporting the dynamic compliance of the bladder. One method of determining dynamic compliance includes the rapid infusion of a volume of fluid into the bladder with immediate measurement of the intravesical pressure. The volume would be more than 50 cc, preferably greater than 100 cc and more preferably greater than 200 cc. The rate of infusion would be less than 10 seconds, preferably less than 5 seconds, and more preferably less than 2 seconds. One embodiment of the present invention includes a two lumen catheter placed within the bladder, wherein a compliant balloon is rapidly filled with a non-compliant material, such as saline is infused through one lumen of the catheter. The resulting intravesical pressure is measured from the other lumen of the catheter. This infusion can be with a syringe, a mechanically assisted syringe or pump.
• An additional embodiment provides methods and devices for treating and/or compensating for reduced dynamic compliance of the bladder. In one embodiment, a device having a compressible element is placed within the human urinary bladder, in a manner that allows the compressible element to act as a pressure accumulator or attenuator to attenuate transient pressure events. The term accumulator refers generally to devices that attenuate pressure, force, or energy in a given locale by absorbing and/or shifting away said pressure, force, or energy from said locale. The term attenuator refers generally to devices that attenuate pressure, force, or energy by dissipating or dampening said pressure, force, or energy. Gases such as atmospheric air, carbon dioxide and nitrogen are very compressible in the pressure ranges typically encountered in the human bladder, and these gases may be used in attenuation devices inserted in the bladder. Furthermore, when compared to the tissues encompassing urine, these gases are significantly more compliant than the immediate environment. The addition of a proportionately smaller volume of unpressurized gas acts as a low rate spring in series with the native fluidic circuit of the urinary tract. Additional information on the basic scientific principles underlying pressure accumulators and methods for controlling transient changes in pressure can be found in E. BENJAMINWYLIE ET AL., FLUIDTRANSIENTS INSYSTEMS§§6, 10, 11, 13 (1993); the entirety of these sections are hereby incorporated by reference herein and made a part of this specification.
• Accumulators can be designed to keep the pressure from exceeding a predetermined value or to prevent low pressures. Accumulators can be designed to protect against rapid transients as well as against longer-period surges in a system. One example of an accumulator is a closed container partially filled with the system liquid and topped with air or gas. The gas may be in contact with the liquid, in which case an air compressor, or gas supply, is used to maintain the proper mass of air or gas, or the gas may be separated from the liquid by a flexible membrane or a piston. The accumulator generally operates at the local system pressure. With reference to the embodiment illustrated inFIG. 45, if thevalve302 of theaccumulator300 is closed abruptly theflow304 enters theair chamber306, the air is compressed, and the flow to themain pipeline308 is gradually reduced as the pressure builds up, thereby provides a way to reduce the peak pressure in thechamber306, themain pipeline308, and other downstream plumbing and equipment.
• In one embodiment, shown inFIG. 46, asingle accumulator300 is assumed to have the same pressure throughout its volume at any given instant. Here, the compressibility of the liquid310 in thevessel312 is considered negligible compared with air compressibility. Assuming inertia and friction are negligible, the gas314 is assumed to follow the reversible polytropic relation H_AVⁿ=C_A, where H_Ais the absolute head equal to the gage plus barometric pressure heads, where Vⁿis the gas volume316, where n is the polytropic exponent, and where C_Ais a constant. The exponent n depends on the thermodynamic process followed by the gas314 in thevessel312. If a perfect gas is assumed, at one extreme the process may be isothermal, n=1, or at the other limit it may be isentropic, in which case n=1.4 for air. It should be noted that computation of the aforementioned values, as well as analogous or related values, can be determined by those skilled in the art by taking into consideration the foregoing discussion.
• In another embodiment, the compression of the enclosed volume of air creates heat that is dissipated into the relatively infinite heat sink of the body. The balance of the energy absorbed by the compressed air is simply returned at a different, lower frequency into the fluidic circuit when the gas is allowed to expand, as the surrounding tissues return to their initial positions. The addition of adequate local compliance can effectively attenuate transient intravesical pressure spikes to levels below the patient's leak pressure, thus obviating the need for relief by means of volumetric displacement of urine, and/or preventing the stimulation of signals to the brain that cause bladder contractions.
• In accordance with one aspect of the present invention, an attenuation device is placed within the human urinary bladder. The attenuation device is intended to be untethered in the bladder and is intended to remain in the bladder for between several hours and one year, between one week and six months, or between one and three months. The attenuation device is a small elastomeric air cell with a relaxed (unstretched) volume of between 1 and 500 cc, more preferably between 1 and 100 cc and more preferably still, between 3 and 25 cc. The attenuation device is a unitary component but can be comprised of two or more subcomponents. The attenuation device has a substantially uniform wall thickness of between 0.25 inch to 0.0001 inch, more preferably between 0.0005 inch and 0.005 inch, but could be designed to vary greatly, and still perform the intended function. In the embodiment described above, attenuation devices having air cells that are free-floating in the bladder have been described. In other embodiments of the present invention, air cells or similar attenuation devices could be surgically affixed to the bladder wall through the use of suture, staples and other accepted methods or placed submucosally or intramuscularly within the bladder wall. Other embodiments could also include attenuation devices with programmable, variable and adjustable buoyancy by using ballasting, specific inflation/deflation solutions, alternative materials of construction or by other means.
• Referring toFIGS. 5 and 5A, there is illustrated one embodiment of anattenuation device66 which comprises a moveable wall such as on aninflatable container68. Theinflatable container68 is illustrated as having a generally circular profile, although other profiles may be utilized in accordance with the present invention. The diameter of theinflatable container68 may be varied within the range of from about 0.25 inches to about 6 inches, in an application of the invention involving the implantation of only a single attenuation device. Many embodiments of theinflatable containers68 will have a diameter within the range from about 1 inch to about 3 inches, with a total volume within the ranges recited above. In general, the specific dimensions and configuration of theinflatable container68 are selected to produce an attenuation device having a desired volume and a desired dynamic compression range, and may be varied from spherical to relatively flat as will be apparent to those of skill in the art based upon the disclosure herein. In certain embodiments, two or three or more discreetinflatable containers68 are utilized. The sum of the volumes of the multiple containers will equal the desired uncompressed displacement.
• Theinflatable container68 illustrated inFIGS. 5 and 5A comprises aflexible wall70, for separating the compressible contents of theattenuation device66 from the external environment.Flexible wall70 comprises a first component74 andsecond component76 bonded together such as by aseam78. In the illustrated embodiment, the first component74 andsecond component76 are essentially identical, such that theseam78 is formed on the outer periphery of theinflatable container68.Seam78 may be accomplished in any of a variety of manners known in the medical device bonding arts, such as heat bonding, adhesive bonding, solvent bonding, RF or laser welding, or others known in the art.
• Theflexible wall70 formed by a bonded first component74 andsecond component76 defines aninterior cavity72. As is discussed elsewhere herein,interior cavity72 preferably comprises a compressible media, such as gas, or foam. Other media or structures capable of reduction in volume through a mechanism other than strict compression may also be used. For example, a material capable of undergoing a phase change from a first, higher volume phase to a second, lower volume phase under the temperature and pressure ranges experienced in the bladder may also be used.
• In order to minimize trauma during delivery of theattenuation device66, the attenuation device is preferably expandable from a first, reduced cross-sectional configuration to a second, enlarged cross-sectional configuration. Theattenuation device66 may thus be transurethrally deployed into the bladder in its first configuration, and enlarged to its second configuration once positioned within the bladder to accomplish the pressure attenuation function. Preferably, a crossing profile or a greatest cross-sectional configuration of theattenuation device66 when in the first configuration is no greater than about 24 French (8 mm), and, preferably, no greater than about 18 French (6 mm). This may be accomplished, for example, by rolling a deflatedinflatable container68 about a longitudinal axis, while theinterior cavity72 is evacuated.
• Once positioned within the bladder, theinterior cavity72 is filled with the compressible media to produce afunctional attenuation device66. The present inventors contemplate fill pressures and volumes of generally less than about 1.5 atmospheres and 50 ml, respectively, and, in some embodiments, less than 0.5 atmospheres and 25 ml, respectively, such as, for example, in the case of an air filledcollapsible attenuation device66. In general, the fill pressure and volume are preferably no more than necessary to keep theattenuation device66 inflated in the absence of pressure spikes. Excessive pressure and volume within theattenuation device66 may shorten the dynamic range of theattenuation device66, thereby lessening the sensitivity to attenuate pressure spikes. Pressures of less than 1 atmosphere, or even vacuums may be utilized if the structure of the attenuation device is sufficient to balance the negative pressure to produce a net force such that attenuation can occur. This may be accomplished, for example, in an embodiment where theattenuation device66 is provided with a self-expandable support structure (e.g. nitinol wire frame), which provides a radially outwardly directed bias.
• The resiliency of the material of the attenuation device, and the pressure and volume of the inflation media are preferably matched to produce a compression cycle time which is fast enough to allow the attenuation device to respond to increases in pressure while not have a clinically detrimental effect on voiding. For example, the attenuation device's compression cycle preferably bottoms out or reaches a maximum in a sufficiently short period of time as detrusor pressure increases that adverse clinical effects on voiding are minimized or prevented.
• To facilitate filling theinterior cavity72 following placement of theattenuation device66 within the bladder, theinflatable container68 is preferably provided with avalve80. In the illustrated embodiment,valve80 is positioned across theseam78, and may be held in place by the same bonding techniques utilized to form theseam78.Valve80 may be omitted in an embodiment in which theattenuation device66 is self-expandable.
• Valve80 generally comprises anaperture82, for receiving a filling tube therethrough.Aperture82 is in fluid communication with theinterior cavity72 by way of aflow path83. At least oneclosure member84 is provided for permitting one way flow throughflow path83. In this manner, a delivery system and filling device can be utilized to displaceclosure member84 and introduce compressible media into theinterior cavity72. Upon removal of the filling device, theclosure member84 prevents or inhibits the escape of compressible media from theinterior cavity72 through theflow path83.
• Thus, theclosure member84 is preferably movable between a first orientation in which it obstructs effluent flow through theflow path83 and a second position in which it permits influent flow through theflow path83. Preferably, theclosure member84 is biased in the first direction. Thus, forward flow may be accomplished by either mechanically moving theclosure member84 into the second position such as using a filling tube, or by moving theclosure member84 into the second position by exerting a sufficient pressure on the compressible media inflow path83 to overcome the closure bias. Certain specific valve structures will be described in connection withFIGS. 8A-E below. However, any of a wide variety of valve designs may be utilized in theattenuation device66 of the present invention as will be apparent to those of skill in the art in view of the disclosure herein.
• In one embodiment, the attenuation device consists of an air cell consisting of 0.0018 inch thick polyurethane sheets that have been bonded together to form a 2⅜ inch circle in top view. In one embodiment, the attenuation device is made from polyurethane and is intended to be inflated to a pressure slightly above atmospheric pressure and a volume less than 50 ml or generally within the range of 0.01 to 1 psi above atmospheric pressure and less than 25 ml. Integral to the sealingedge78 of the attenuation device holds a port/valve80 utilized in the placement, inflation and release of the attenuation device. Into the port/valve structure80 is placed the distal end of a rigid fill tube (0.050″ OD)50. Thevalve80 employed may be one of the valves described in U.S. Pat. No. 5,144,708, which is incorporated herein by reference. In another embodiment, the attenuation device may be ultrasonically, radio frequency, adhesively or heat sealed in situ following inflation, in which case the valve may be omitted.
• Biocompatible lubricating substances may be used to facilitate the placement of the attenuation device/fill tube within the lumen of the introducer. The distal tip of the introducer has been modified to allow a minimally traumatic presentation of the attenuation device to the urethral tissue. Biocompatible lubricating substances may be used to facilitate the insertion of the attenuation device into the urethra.
• In one embodiment, the attenuation device incorporates biocompatible coatings or fillers to minimize irritation to the bladder wall and mucosa and/or to inhibit the formation of mineral deposits (encrustation). The materials can be coated onto the surface or incorporated within the wall of the attenuation device.
• Referring toFIG. 6, there is illustrated one delivery system for deploying the attenuation device into the treatment site, such as, for example, the bladder, in accordance with the present invention. In general, thedelivery system40 is designed to advance an attenuation device66 (not illustrated) transurethrally into the bladder while in a first, reduced cross-sectional configuration, and to thereafter inflate or enlarge or permit the expansion of the attenuation device to a second, implanted orientation. The particular configuration and functionality of thedelivery system40 will therefore be governed in large part by the particular design of theattenuation device66. Thus, as will be apparent to those of skill in the art in view of the disclosure herein, various modifications and adaptations may become desirable to the particular delivery system disclosed herein, depending upon the construction of the corresponding attenuation device.
• Thedelivery system40 comprises an elongatetubular body42 having aproximal end44 and adistal end46.Tubular body42 is dimensioned to transurethrally access the bladder. Thus, thetubular body42 preferably has an outside diameter of no more than about 8 mm, and, preferably, no more than about 4 mm. The length of thetubular body42 may be varied, depending upon the desired proximal extension of thedelivery system42 from the urethra during deployment. In general, an axial length oftubular body42 within the range of from about 1″ to about 10″ for adult female patients and from about 4″ to about 30″ for adult male patients is currently contemplated.
• Thetubular body42 is provided with at least onecentral lumen48 extending axially therethrough.Central lumen48 axially slideably receives a fillingtube50, for filling theattenuation device66. Fillingtube50 comprises a tubular body52 having aproximal end54 and adistal end58. Aninflation lumen60 extends throughout the length of the tubular body52, and is in fluid communication with aproximal hub56.Hub56 comprises a connector such as a standard luer connector for coupling to a source of inflation media.
• The tubular body52 has an axial length which is sufficiently longer than the axial length oftubular body42 to allow theproximal hub56 to remain accessible to the clinician and accomplish the functions of deploying and filling theattenuation device66. In one embodiment, an outer tubular sheath (not illustrated) is slideably carried over thetubular body42, and is spaced radially apart from the tubular body52 to define an annular cavity for receiving a rolledattenuation device66 therein. In this manner, the deflated attenuation device can be rolled around a distal portion of the tubular body52 and carried within the tubular sheath during transurethral placement. Once thedelivery system40 has been properly positioned, proximal retraction of the outer sheath with respect to the tubular body52 exposes the deflatedattenuation device66. A source of inflation media is coupled to theproximal hub56, and media is introduced distally throughcentral lumen60 to inflate theattenuation device66. Following inflation of theattenuation device66, thedelivery system40 is disengaged from theattenuation device66, such as by retracting the fillingtube50 with respect to thetubular body42. Adistal stop surface47 ontubular body42 prevents proximal movement of theattenuation device66 as the fillingtube50 is proximally retracted.Delivery system40 is thereafter removed from the patient, leaving theinflated attenuation device66 within the bladder.
• With reference toFIGS. 6A and 6B, there is illustrated a modified version of thedelivery system40. In this embodiment, acontrol62 is connected by way of aproximal extension60 to the tubular body52. Thecontrol62 may be in any of a variety of forms, such as a knob or a pistol grip. Thecontrol62 may be grasped by the clinician, and utilized to axially advance or retract the fillingtube50 within thetubular body42. Theproximal hub56 is connected to the tubular body52 by way of abifurcation61. As will be appreciated by those of skill in the art, thecentral lumen60 extends through thebifurcation61 and to theproximal hub56.Proximal extension60 may comprise a blocked tubular element or a solid element. Aninflation source64 such as a syringe filled with a predetermined volume of air or other media may be connected to theproximal hub56.
• For patient comfort, the introducer is suitably sized to easily pass through the urethra (approximately 0.5 to 4 mm diameter). Visual feedback is provided to the clinician by means of insertion depth indicators along the longitudinal length of the introducer. The introducer may also have an adjustable depth stop that allows the clinician to pre-set the desired insertion depth. Once the delivery system has been inserted into the urethra to the desired depth the introducer is then kept in a fixed position and the attenuation device mounted on the distal end of the fill tube is then extended in the lumen of the bladder. The attenuation device is then filled with the indicated volume of gas from the attached syringe or similar device. SeeFIGS. 9, 10, 11, and 11A. Once properly inflated, the attenuation device is released from the fill tube using the tip of the introducer as an opposing force disengaging the attenuation device valve from the fill tube. The fill tube is then retracted completely into the lumen of the introducer and the entire delivery system is then withdrawn from the patient. The attenuation device is left in place for the clinically indicated period of time.
• One aspect of the present invention relates to the delivery of a very flexible, thin walled device. Delivery of an attenuation device is typically accomplished via a suitably sized introducer or possibly through the working channel of an endoscope or cystoscope. However, in certain instances the columnar strength of an attenuation device may make it difficult to be pushed through such channels. A further requirement of any delivery system is that it be atraumatic, and not pose a threat of tissue damage. This invention addresses such issues, and offers improvements for accomplishing delivery of such attenuation devices as disclosed in co-pending applications U.S. Application Ser. No. 60/197,095, filed Apr. 14, 2000, titled DEVICES AND METHODS FOR BLADDER PRESSURE ATTENUATION, and U.S. application Ser. No. 09/723,309, filed Nov. 27, 2000, titled DEVICES AND METHODS FOR ATTENUATION OF PRESSURE WAVES IN THE BODY.
• The attenuation device is normally folded on itself along its diameter in order to present a low profile for insertion into, for example, a patient's bladder transurethrally. In this configuration the attenuation device has insufficient column strength to withstand the forces of insertion without buckling. If the attenuation device buckles it cannot be inserted. Following insertion the attenuation device is inflated via an inflation tube to which it is pre-mounted. After inflating the inflation tube is detached and the attenuation device is freed. By way of illustration, various embodiments of the invention will be described in the exemplary context of transurethral insertion of a delivery system into a patient's bladder.
• In one embodiment, shown inFIGS. 34A and 34B, there is provided an delivery system for the attenuation device which consists of an inner fenestrated tubular member which is provided with an atraumatic rounded tip at its distal end, and an slideably mounted outer coaxial tubular member. The rounded tip is shaped such that its proximal end, which is inserted into position in the distal end of the inner tubular member, presents essentially a “ramp” designed to aid ejection of the attenuation device from the fenestration when it is advanced. The attenuation device to be delivered is attached to its inflation tube, folded as previously described, and drawn into the inner sheath through the fenestration. Once situated within the fenestration the outer coaxial tubular member is slid forward to close the fenestration, thus containing the bladder within the inner tube.
• With reference to the embodiment illustrated inFIG. 34A,delivery system370 comprises aninner sheath372, a slideableouter sheath374, anopening376 in the inner sheath, and anatraumatic tip378. With reference to the embodiment illustrated inFIG. 34B,delivery system370 comprises anouter sheath374 that slides backwards and anattenuation device380. Here, theattenuation device380 is exposed through theopening376. Thedelivery system370 comprises aninflation tube382 that is advanced toward theatraumatic tip378, thereby causing theattenuation device380 to be ejected. Acurved ramp384 in thedelivery system370 aids the ejection of theattenuation device380.
• In use the distal end of the delivery system is inserted through the urethra to an appropriate depth, the outer coaxial tube is slid backwards along the inner tube, thus exposing the fenestration in the inner tube. The attenuation device is advanced using the inflation tube and releases easily from the inner tube. The attenuation device is inflated, released from the inflation tube, and floats freely in the bladder.
• In another embodiment, shown inFIGS. 35A and 35B, the attenuationdevice containment tube386 is a simple open-ended cylinder. Theattenuation device380 is folded as described previously and withdrawn into thecontainment tube386. The open end of thecontainment tube386 would present a potentially traumatic edge to the urethra. In order to prevent such trauma, the open end of thecontainment tube386 in this instance has roundedatraumatic end378. Thisend378 containsslits388 which, on sliding thecontainment tube386 backwards allows theend378 to open, thus allowing deployment of theattenuation device380 from thecontainment tube386. On advancing theinflation tube382 with theattenuation device380 attached, theslits388 open and present little barrier to the deployment of the attenuation device.
• In another embodiment, the attenuation device is delivered percutaneously through the pelvis into the bladder. Similar to percutaneous access of arteries or veins, a needle is inserted through the skin and into the bladder. A guide wire is placed through the needle and the needle is removed leaving the guide wire in place. The delivery system and attenuation device are pushed into the bladder over the guide wire. The attenuation device is deployed and the delivery system and guide wire are removed. Guidance using ultrasound can also be employed to help guide the delivery system into the bladder.
• In one embodiment, a removable delivery system is used to deliver, deploy, and fill the attenuation device. The delivery system can take the form of the system taught by U.S. Pat. No. 5,479,945, titled method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders, issued Jan. 2, 1996, the disclosure of which is incorporated in its entirety herein by reference.
• With reference toFIGS. 7A and 7B, there is illustrated one disengagement sequence for deploying theinflatable attenuation device66 from thedelivery system40 in accordance with one aspect of the present invention. As illustrated inFIG. 7A, thedelivery system40 is initially configured with the fillingtube50 positioned within thevalve80. Thedistal end46 of outertubular body42 is dimensioned such that it will not fit through theaperture82 ofvalve80. Once theattenuation device66 has been positioned within the bladder, theattenuation device66 is inflated through fillingtube50.
• With reference toFIG. 7B, the fillingtube50 is proximally retracted following inflation so that it disengages from thevalve80. This is accomplished by obstructing proximal movement of theattenuation device66 bystop surface47 on thedistal end46 oftubular body42. Theattenuation device66 is thereafter fully disengaged from thedelivery system40, and thedelivery system40 may be removed.
• With reference toFIGS. 8A, 32A, and 32B, there is illustrated a duckbill embodiment of thevalve80.Valve80 comprises atubular wall81, having anaperture82 in communication with aflow path83. At least oneclosure member84 is attached to the tubular wall, and extends across theflow path83. In the illustrated embodiment,closure member84 comprises a first and a second duckbill valve leaflets86 and88 which are attached atlateral edges90 and92 to the tubular wall. Theleaflets86 and88 incline medially in the distal direction to a pair of coaptive edges94 and96. This configuration allows forward flow throughflow path83 to separate coaptive edges94 and96, thereby enabling inflation of theattenuation device66. Upon removal of the inflation media source, the inflation media within theattenuation device66 in combination with natural bias of theleaflets86 and88 cause the leaflets to coapt, thereby preventing effluent flow of inflation media through theflow path83.
• Thetubular body81 and first andsecond leaflets86 and88 may be manufactured from any of a variety of materials which will be apparent to those of skill in the art. For example,tubular body81 may be made from polyurethane such as by extrusion.Leaflets86 and88 may be made from any of a variety of flexible materials such as polyurethane, silicone, or polyethylene, and may be bonded to thetubular element81 using adhesives, heat bonding, or other bonding techniques known in the art. Suitable valves include the valve manufactured by Target Therapeutics and sold as the DSB silicon balloon to fill aneurysms and arterial-venous malformations.
• With continued reference toFIGS. 8A, 32A, and 32B, in one method of manufacturing theattenuation device66, thebushing249 is RF welded to theinflatable container68 prior to installing thevalve80. Here, theduckbill valve80 is bonded to thebushing249 after welding. In one method of manufacturing theattenuation device66, the mandrel is installed during welding, resulting in a polished surface with an air-tight seal along the inside of the tube.
• Referring toFIG. 8B, closure is accomplished by two coaptive edges ondistal end106 oftubular body81. This construction is sometimes referred to as a flapper valve. Thetubular body81 in this embodiment is formed by afirst wall96 and asecond wall100 which are bonded or folded along afirst edge102 and asecond edge104 to define aflow path83 extending therethrough. The free distal ends of first andsecond walls96 and100 at thedistal end106 form coaptive leaflets, which may be opened under forward flow pressure through theflow path83 and will inhibit or prevent reverse flow through theflow path83.
• Referring toFIG. 8C, the proximal end of theflow path83 on the flapper valve ofFIG. 8B or other valve structure may be reinforced such as by a reinforcingtube108. Reinforcingtube108 may be manufactured in any of a variety of ways. For example, reinforcingtube108 may be extruded from various densities of polyethylene, Pebax, polyurethane, or other materials known in the art. Reinforcingtube108 may be desired to maintain patency of the pathway to thevalve80, particularly in an embodiment adapted for coupling to a deflation and removal system as will be discussed. In another embodiment, the reinforcingtube108 may be removable and used to prevent sealing of the valve during the manufacturing process and may also ease the placement of a fill tube in the valve. This reinforcingtube108 is removed after the manufacturing process is complete, or may be removed before, during, or after the fill tube is placed.
• With reference toFIGS. 8D and 33A, there is illustrated an additional feature that may additionally be incorporated into any of the valves discussed above. In one embodiment of this feature, anannular sealing ring110 is provided on the interior surface of thetubular body81.Annular sealing ring110 is adapted to provide a seal with the fillingtube50, to optimize the filling performance of the attenuation device.Sealing ring110 is thus preferably formed from a resilient material such as silicone or polyurethane and dimensioned to slideably receive the fillingtube50 therethrough. In another embodiment, sealing with the fill tube may be enhanced by restricting the aperture diameter without the use of adistinct sealing ring110. Exemplary dimensions of theattenuation device66 are shown inFIG. 33A.
• With reference toFIGS. 8E and 33C, the valve may also be placed in the body of the attenuation device, rather than in the seam. In one exemplary embodiment, the throughhole258 has a diameter of 0.062 inches. Here, the inflation channel256 has a diameter of approximately 0.063 to 0.070 inches. The valve can be placed in any number of ways including the methods described in U.S. Pat. No. 5,248,275, titled Balloon with flat film valve and method of manufacture, issued Sep. 28, 1993, and U.S. Pat. No. 5,830,780, titled Self-closing valve structure, issued Nov. 3, 1998; both of these patents are hereby incorporated by reference herein and made a part of this specification.
• In one embodiment, shown inFIG. 33B, thevalve80 has a fill/plug250. In one method of manufacturing the fill/plug attenuation device66, the mandrel is installed during welding, resulting in a polished surface with an air-tight seal along the inside of the tube.
• Theattenuation device66 is preferably also removable from the bladder. Removal may be accomplished in any of a variety of ways, depending upon the construction of the attenuation device. Preferably, removal is accomplished transurethrally. In one embodiment, removal is accomplished by reducing theattenuation device66 from its second enlarged profile to its first, reduced profile so that it may be withdrawn transurethrally by a removal system. The removal system will be configured differently depending upon whether reduction from the second profile to the first profile is accomplished by deflation, or by compression. One embodiment of a removal system utilized to remove aninflatable attenuation device66 will be described below in connection withFIG. 12.
• In another embodiment, the removal procedure involves dissolving or degrading the material or a portion of the material of theattenuation device66 in situ. Material selection and wall thickness of theattenuation device66 may be optimized to provide the desired useful life of theattenuation device66, followed by dissolution in the aqueous environment of the bladder. In one embodiment, dissolution or deflation may be catalyzed or accelerated by an accelerating event such as a change in pH or introduction of an initiator or accelerator into the bladder, or reduction of pressure.
• Attenuation devices having a predetermined dwell time after which they are automatically voided advantageously eliminate the need for a removal procedure. Such temporary attenuation devices can be manufactured in a variety of ways in accordance with the present invention, such as through the use of bioabsorbable or permeable materials. In one embodiment, the entire wall of theinflatable container68 is made from an absorbable material. As used herein “absorbable” means any material which will dissolve, degrade, absorb or otherwise dissipate, regardless of the chemical mechanism, to achieve the purpose recited herein. In another embodiment, only a portion of theflexible wall70 or other portion of the attenuation device such as the valve is made from an absorbable material. As soon as one or more windows or “fuse” components of the attenuation device is absorbed, the attenuation device will deflate through the resulting opening and can be expelled during normal voiding. In yet another embodiment, one or more seams such asseam78 can be bonded by a dissolvable or absorbable material that is designed to fail after a predetermined time in the aqueous environment of the bladder.
• The resulting deflated components from any of the foregoing time limited embodiments can thereafter either be expelled during normal voiding, or can remain in the bladder in a deflated state until removed using a removal system. In one embodiment, the material or portion of theinflatable container68 is made from a gas permeable material. As the gas dissipates from the inflatable container, its ability to spontaneously void increases. In one embodiment, the attenuation device is filled with approximately 20 ml of gas and the attenuation device's material allows approximately 15 ml of gas to permeate out of the attenuation device over certain time intervals, such as, for example, one, three, six, or twelve months. Once the volume remaining is less than approximately 5 ml, the attenuation device is normally voided.
• The predetermined dwell time within the bladder can be influenced by a variety of design factors, including the formulation of the absorbable material and the physical shape, thickness and surface area of the absorbable component. A variety of absorbable polymers which can be used in the present invention are known in the absorbable suture arts. For example, absorbable multifilament sutures such as DEXON sutures (made from glycolide homopolymer and commercially available from Davis & Geck, Danbury, Conn.), VICRYL sutures (made from a copolymer of glycolide and lactide and commercially available from Ethicon, Inc., Somerville, N.J., and POLYSORB sutures (also made from a copolymer of glycolide and lactide and commercially available from United States Surgical Corporation, Norwalk, Conn.) exemplify materials known in the industry and characterized as short term absorbable sutures. The classification short term absorbable sutures generally refers to surgical sutures which retain at least about 20 percent of their original strength at three weeks after implantation, with the suture mass being essentially absorbed in the body within about 60 to 90 days post implantation.
• Certain bioabsorbable elastomers may also be used to form the attenuation devices or fuses in accordance with the present invention. The elastomers can be melt-processed, for example by extrusion to prepare sheets, plugs or tubular structures. In one embodiment, the copolymers can be injection molded to fabricate intricately designed parts, or compression molded to prepare films. For the details of such melt-processing techniques, see, for example, F. Rodriguez, Principles of Polymer Systems, Chapter 12 (McGraw Hill1970).
• The bioabsorbable elastomers can also be solvent cast to prepare thin films. Solvent casting can be accomplished using conventional methods such as first dissolving the copolymer in a suitable solvent to make a solution, then casting the solution on a glass plate to make a film, and then evaporating the solvent from the cast film. In another processing scheme, the copolymers can be lyophilized to prepare foams. Lyophilization can be accomplished by first dissolving the copolymer in an appropriate solvent, freezing the solution, and then removing the solvent under vacuum. The set of appropriate solvents include p-dioxane. Lyophilization techniques to prepare films are described in Louis Rey, Aspects Theoriques Et Industriels De La Lyophilization (1964).
• Certain bioabsorbable elastomers are disclosed in U.S. Pat. No. 6,113,624, titled Absorbable elastomeric polymer, issued Sep. 5, 2000, the disclosure of which is incorporated in its entirety herein by reference. In accordance with the process disclosed therein, a two-step, one-reaction vessel, two-temperature process is utilized in which a mixture of p-dioxanone monomer and p-dioxanone homopolymer, is formed at low temperatures of from about 100° C. to about 130° C., preferably 110° C. The mixture is then reacted with lactide at temperatures from about 120° C. to about 190° C. to form copolymers in which segments or sequences are composed of both p-dioxanone and lactide repeating units. These segmented copolymers are stated to be less crystalline than the block or graft copolymers previously known in the art and, therefore, yield materials with good strength, but shorter BSR (“Breaking Strength Retention”) profiles, faster absorption rates, much longer elongations and lower stiffness than the block copolymers. A wide variety of copolymers of polylactic and polyglycolic acids are also known in the art, particularly for use with absorbable orthopedic screws and fasteners.
• The ideal material can be optimized through routine experimentation taking into account the attenuation device design and the desired indwelling time period. Attenuation devices may be time rated, such as 15 days, 30 days, 45 days, 90 days, 180 days or other as may be desired. The deflated and/or partially dissolved attenuation device will be transurethrally expelled within a few days of the expiration of the rated time period from the time of implantation.
• Referring toFIG. 12, there is illustrated a side elevational schematic view of one embodiment of an intravesical removal system in accordance with the present invention. This removal system is adapted to retrieve the inflatable attenuation device discussed elsewhere herein. Theremoval system150 comprises an elongatetubular body152 which extends between aproximal end154 and adistal end156.Tubular body152 is dimensioned to transurethrally access the bladder. In one embodiment, theremoval system150 is adapted for use in conjunction with standard urological cystoscopes (e.g. approximately 14-24 French), having minimum working channels of approximately 1.8 to 6.0 mm. For this purpose,removal system150 in one embodiment has an overall length of approximately 76 cm and a useable length of approximately 60 cm.
• Thetubular body152 may be manufactured in accordance with any of a variety of techniques well understood in the catheter and other medical device manufacturing arts. In one embodiment,tubular body152 is extruded from a biocompatible material such as TFE, having an inside diameter of approximately 0.09 inches and a wall thickness of about 0.01 inches.
• Theproximal end154 oftubular body152 is connected to a Y-adaptor158. Y-adaptor158 carries acontrol160 for controlling the retrieval system as will be described.Control160 in the illustrated embodiment comprises athumb ring162 which is slideably carried with respect to a pair of finger rings164. Axial movement of thethumb ring162 with respect to the finger rings164 enlarges or retracts aretrieval loop166 extending distally fromdistal end156 oftubular body152.Retrieval loop166 is adapted to surround theinflated attenuation device66. In one embodiment, theloop166 has an enlarged diameter of about 27 mm, and comprises a wire such as 0.016 inch diameter stainless steel cable wire.
• In use, theloop166 is opened once thedistal end156 of thetubular body152 has reached the bladder. Theloop166 is positioned around theattenuation device66, and theproximal control160 is manipulated to tighten theloop166 around theattenuation device66. After theattenuation device66 has been securely grasped by theloop166, a deflatingtube168, preferably having a sharpeneddistal tip169 thereon, is distally advanced through the wall of theattenuation device66. Distal advancement of the deflatingtube168 may be accomplished by distally advancing a proximal control, such ascontrol172. Thedistal tip169 is in fluid communication with a connector such as astandard luer adaptor170 through a central lumen (not illustrated), so that an empty syringe or other device may be connected to theconnector170 and used to evacuate the contents of the ensnaredattenuation device66. As theattenuation device66 is deflated, thecontrol160 may be manipulated to pull thecollapsed attenuation device66 into thedistal end156 of thetubular body152. Theremoval system150 having the reducedattenuation device66 therein or carried thereby may be transurethrally removed from the patient.
• A wide variety of modifications can be made to the foregoingremoval system150, within the spirit of the present invention. For example, theproximal controls160 and172 may be combined into a pistol grip or other configuration.Controller172 orcontrol160 may additionally control deflection of thedistal end156 of thetubular body152, or control rotation of the plane of theloop166. In general, theremoval system150 preferably accomplishes the basic functions of enabling the location of theattenuation device66, capturing the attenuation device, reducing the attenuation device in size and removing the attenuation device from the bladder. The capturing step may be accomplished by visualizing the attenuation device through the urological cystoscope, or by “blind” techniques, such as, for example, light reflectance, impedance, suction, ultrasound, passive induced microchip, or the magnetic locator described in connection withFIGS. 21, 22, 23, below.
• Referring toFIGS. 13 and 13A, there is illustrated a top plan view of one embodiment of anattenuation device180 in accordance with one aspect of the present invention. Theattenuation device180 comprises aninflatable body68 generally as has been described. Anouter seam78 may be provided with avalve80. In this embodiment, aninner seam182 defines acentral region184. Theouter seam78 andinner seam182 define a generally toroidal-shapedinflatable container68. Thecentral region184 may comprise either a membrane or a central opening, depending upon the desired performance characteristics. The center hole may assist in the placement and location of the attenuation device within the bladder, permit additional baffling of the pressure waves within the bladder, minimize the attachment to the bladder wall by surface tension between the attenuation device and the bladder wall, and allow for urine flow through the hole in the event that the attenuation device is in or near the bladder neck.
• In one embodiment, illustrated inFIGS. 14 and 14A, thecentral region184 comprises abaffle186. Thebaffle186 comprises amembrane188 having a plurality ofapertures190 therein. In the illustrated embodiment, approximately nineround apertures190 are provided, each having a diameter of about 0.2 inches. Generally at least about 9apertures190 are provided, and many embodiments include anywhere from about 1 to about 1000 apertures. The optimal number ofapertures190 and sum of the area of theapertures190 compared to the total area of thebaffle186 may be optimized depending upon the desired performance characteristics. Apertures may have any of a variety of configurations, such as round holes, irregular openings, slits or others.
• The wave diffuser function of thebaffle186 is schematically illustrated inFIG. 15. Awave front192 may be generated by any of a wide variety of events, such as coughing, sneezing, laughing, physical movement, muscle spasms or others as is understood. Since urine comprises essentially non-compressible water, and due to the low dynamic compliance of the bladder thewave front192 will propagate rapidly through the bladder to impact structures such as the trigone area and the urethra. Apparent transient pressure spikes as high as 80 cm H₂O or greater can be experienced during normal activities. In addition to reducing the pressure caused by pressure events such as coughing, the attenuation devices discussed above can also provide a baffle that distributes the wave across the bladder distributing and reducing the focused wave front that contacts the bladder neck.
• If theattenuation device180, having abaffle186 is positioned within the bladder, thebaffle186 functions to disrupt the unitary progression of thewavefront192. Theprediffusion wave front192 is thus interrupted into a plurality ofpost-diffusion wave fronts194 by thebaffle186. Although the sum of the resultingpost-diffusion wave fronts194 is essentially equal to theprediffusion wave front192, the greater dispersion of force accomplished by thebaffle186 is believed by the inventors to reduce the apparent magnitude of thewave front192 as experienced by target tissue within the bladder.
• As will be apparent in view of the foregoing, thebaffle186 may be constructed in any of a variety of manners and still accomplish the intended result. Thus, although theattenuation device180 illustrated inFIGS. 13 and 14 comprises a generally toroidal-shaped inflatable container, any of a variety of other support structures may be utilized to maintain thebaffle186 in a useable configuration. Thesupport196 can comprise an inflatable tube, a resilient material such as nitinol wire, or other support structure as may be desired.
• Certain embodiments of the present invention include a device that is mechanically in contact with the mucosal tissue of the bladder or urethra. The sensation caused by the mechanical contact causes nerve receptors to tighten the urethral muscles increasing urethral resistance, thus, reducing or eliminating incontinence events.
• Referring toFIG. 16, there is illustrated a variety of shapes for theattenuation device66, of the inflatable container variety. The devices used in embodiments of the present invention may take many shapes. In some instances it may be desirable for manufacturing purposes to have the shape resemble dip-molded devices like condoms, surgical glove fingers, or children's toys. However, many other forms may provide better performance, in particular for providing baffling of pressure waves as well as attenuation of pressure spikes. Possible shapes for the attenuation devices include toroid like shapes, similar in form but not size to donuts and inner tubes; spoked wheel forms; horseshoe-like forms; mushroom-like forms; and banana-like forms.
• The attenuation devices of the present invention can be dip molded or extruded in a plurality of biocompatible materials. Furthermore, the attenuation devices can be fabricated from a variety of multi-layer composites or produced by a number of different manufacturing processes. Here, the designs of the attenuation devices are characterized by minimization and control of the gas and moisture vapor permeabilities in and out of the attenuation device.
• The gas and moisture vapor permeabilities of any given material will vary depending on the conditions surrounding the material. For example, an attenuation device comprised of a certain material can have different gas and/or moisture permeabilities within the bladder than at standard temperature and pressure. In addition to exposure to urine, the intravesical environment includes exposure to pressure variations in the range of from about 0.05 psi to about 0.25 psi at rest, with transient pressure spikes as high as 2 psi or more. The body temperature is normally about 98 degrees F. or greater, and the attenuation device resides in 100% humidity. Long term efficacy of the attenuation device may be compromised if there exists any fluid or vapor exchange through the wall of the attenuation device in situ. The relative impermeability of the wall under normal intravesical conditions is preferably accomplished without losing the compliancy of the attenuation device which allows it to compress within folds of the bladder as is described elsewhere herein.
• In general, the wall of the attenuation device will comprise at least one gas barrier layer and at least one moisture barrier layer. Any of a variety of gas barrier materials (e.g. polyvinylidene chloride, ethyl vinyl alcohol, fluoropolymers, etc.), available in thin film constructions, may be implemented into the attenuation device design. These materials are generally relatively stiff, have a high moisture vapor permeability, and have low impact strength. Consequently, layering the film with flexible, high moisture barrier, high impact strength polymers is desirable.
• A variety of relatively flexible materials, having high moisture barrier characteristic and optionally high impact strength that can be formed into thin film sheets include but are not limited to: polyamide, polyethylene, polypropylene, polyurethane, polyamide/polyester copolymer, polystyrene/polybutadiene copolymer, etc. In one embodiment, at least one layer on, or the entire attenuation device comprises a blend of a barrier material and a flexible high impact strength material (e.g. polyurethane/polyvinylidene chloride, polyethylene/ethyl vinyl alcohol, etc.).
• The attenuation device typically has two or more layers or barriers. For example, the attenuation device can have a gas barrier layer and a moisture barrier layer. An additional layer may be included to enhance the structural integrity of the attenuation device. In one embodiment, the attenuation device has an outer layer comprising a gas barrier and an inner layer comprising a moisture barrier. In another embodiment, the attenuation device has an outer layer comprising a moisture barrier and an inner layer comprising a gas barrier.
• The attenuation device can have three, four, five, or more layers. In one embodiment, the attenuation device has a gas barrier layer, a moisture barrier layer, and one or more layers composed of at least one high impact strength material. In another embodiment, the attenuation device has multiple gas barrier layers arranged in a nonconsecutive arrangement. In yet another embodiment, the attenuation device has multiple moisture barrier layers arranged in a nonconsecutive arrangement. With respect to those embodiments having multiple, nonconsecutive barrier layers, the other layers of the attenuation device can include high impact strength material layers and/or other types of barrier layers.
• The overall thickness of the wall is preferably minimized, and will often be no more than about 0.03 inches. Preferably, the wall will be no more than about 0.006 inches, and, in some implementations, is no more than about 0.003 inches thick. An outer layer may comprise a soft, conformable material such as polyurethane, EVA, PE, polypropylene, silicone or others, having a thickness within the range of from about 0.0025 inches to about 0.025 inches. The adjacent barrier layer may comprise EVOH, PVDC or other materials in a thin film such as from about 5 microns to about 25 or 30 microns thick. If the attenuation device is fabricated by bonding two sides together, a bonding or tie layer may be provided on the barrier layer. Tie layers comprising polyurethane, EVA or others may be used, having a thickness of preferably no greater than about 0.001 inches. Layers of less than about 0.0008 are preferred, and layer thicknesses on the order of from about 0.0003 to about 0.0005 inches are contemplated.
• The layers of the attenuation device can be formed in any number of ways known to those skilled in the art, including, but not limited to, lamination, coextrusion, dip molding, spray molding, or the like, etc. As discussed above, the layers of the attenuation device can be formed from various materials. With respect to those attenuation devices that are formed by laminating two or more layers together, various different laminating techniques known to those skilled in art can be used, including, but not limited to, heating, solvents, adhesives, tie layers, or the like.
• The material may not need to be elastomeric at all for the attenuation device to function. However, the materials chosen for use in embodiments of the present invention are to be sufficiently flexible in the thickness ranges dictated by the selected designs. When the attenuation device is subjected to external pressures, the attenuation device's material is able to transmit the pressure to the contained air or pressure management construct and respond sacrificially as one of the most compliant members of the urinary system.
• FIG. 16A illustrates a toroidal embodiment, in which a plurality of central spokes are provided.FIG. 16B illustrates a crescent or “C” shaped attenuation device. Any of a variety of spherical, oval, elliptical or other shapes may be utilized such as those illustrated inFIG. 16C, in which the greatest length dimension of the inflated attenuation device is within the range of from about 1 to about 5 times the smallest cross-section.FIG. 16D illustrates a less arcuate variety as shown inFIG. 16B. In general, theattenuation device66 may take any of a variety of forms which provides a sufficient volume to achieve the desired attenuation function, and which will minimize or eliminate risk of loss or obstructing outflow through the urethra.
• Referring toFIGS. 17A and 17B, there is illustrated an axially-compressible mechanical bellows type attenuation device in accordance with the present invention. Attenuation device embodiments of the present invention for absorbing transient pressure changes include diaphragmatic structures, rigid structures both shape changing and rigid with a coating or a bellows or bellows-like structure that can dampen pressure waves in an organ, chamber or cavity of the body as stand alone attenuation devices or as part of the wall or structure of the organ of interest. One embodiment of a mechanically assisted attenuation device is inFIGS. 17A and 17B.FIG. 17A is a mechanical bellows that is in a normally extended position. The pressure within the bellows is reduced such that the bellows normally retains its extended position, but will compress when external pressure is exerted on it. The bellows could be made from plastic or metal, such as, for example, titanium or stainless steel from Senior Flextronics, Inc. Sharon, Mass. The bellows may be sealed, or covered in a material that allows for the reduction of air pressure within the structure.
• This approach has the advantage for significantly greater change of volume with change of pressure. The theoretical limits of the air cell described herein can only be reduced approximately 25% of its volume, but this bellows system can contract to almost 90% of its volume.
• Thebellow attenuation device200 comprises amembrane202, which is collapsible in an accordion fashion. Themembrane202 may be self-supporting, or may be provided with an internal or external frame. The frame may comprise any of a variety of structures, such as a simple spring aligned in parallel with the longitudinal axis of the bellow, or pivotably moveable structures such as an axially compressible wire pantograph as will be understood in the art.
• Referring toFIG. 18, there is illustrated a mechanically-assistedattenuation device210 in accordance with the present invention. In this embodiment, a compressibletubular wall212 having closed ends214,216 is supported by a self-expandingtubular frame218. Any of a variety of self-expanding tubular or spherical frame structures may be utilized, such as “zigzag” wire frames well known in the abdominal aortic aneurysm graft arts. Although the abdominal aortic aneurysm graft application generally requires a relatively high, radially outwardly directed force, the present application would preferably be compressible with a relatively low compressive force (i.e., low radial force). This may be accomplished by using wires of smaller gauge, less wire per graft, leaving adjacent apexes unconnected to each other, or other technique to reduce the radial force of the wire cage. The wire cage or other support structure is preferably surrounded by a water impermeable membrane such as a balloon. Pressure within such balloon may be lower than 1 atm.
• Referring toFIGS. 19A and 19B, there is illustrated another layout for theinflatable attenuation device66 of the present invention. In this embodiment, illustrated inFIG. 19A, a plurality ofattenuation devices67 are connected by acommon flow path65, so that the plurality ofattenuation devices67 can be inflated through a single fill port. In another embodiment, illustrated inFIG. 19B, a plurality of self-expanding attenuation devices are connected by a suture, Nitinol wire, or other tether, thereby minimizing the crossing profile and/or maintaining a constant crossing profile for an attenuation device of any desired total inflated volume.
• FIGS. 20-23 illustrate a magnetic locating system for enabling “blind” retrieval without the use of a cystoscope. To remove the attenuation device from the bladder, the removal system is inserted into the urethra for intravesical capture, deflation, and extraction of the attenuation device. The removal system utilizes a magnet whose polarity and flux path is oriented in a manner to ensure predictable attraction and coupling of a magnet-containing attenuation device to the removal system. The removal system is coupled back to the attenuation device, and the attenuation device may be punctured and deflated using the jaws of biopsy-like forceps (or other solution suitable for deconstructing the device) located at the distal end of the removal system. In one embodiment, residual gas may be passively vented into the bladder or through the retriever body. Once deflated the attenuation device may be withdrawn through the urethra attached to the removal system or allowed to pass out of the bladder as part of the urine flow.
• Thus, referring toFIG. 20, there is illustrated anattenuation device230 such as aninflatable balloon229 as has been described previously herein. Theattenuation device230 is provided with avalve232 and a locatingelement234. Locatingelement234 may be any of the variety of structures which enable location of theattenuation device230, preferably without the need for direct visualization.
• In the illustrated embodiment, the locatingelement234 is one ormore magnets236. In the embodiment illustrated inFIG. 21, themagnet236 comprises an annular ring, for surrounding theflow path83. Acorresponding magnet238 having reversed polarities from the polarity of themagnet236 is provided on the distal end of acatheter240. The attractive forces of the opposingpolarity magnets236 and238 will cause thecatheter240 to couple on to theattenuation device230, as illustrated inFIG. 22, when thecatheter240 is positioned in the vicinity of theattenuation device230.
• Referring toFIG. 22, at least onelumen242 places theattenuation device230 in fluid communication with thecatheter240 when the locatingelement234 is coupled to thecatheter240. Thislumen242 may be utilized to either introduce inflation media or remove inflation media from theattenuation device230. InFIG. 22, thevalve232 is a ball valve, which is biased in the closed orientation. However, the mechanism and structures disclosed herein may be used on any of the other valves disclosed elsewhere herein. In one embodiment, illustrated inFIG. 22, avalve actuator234 may be advanced distally through thelumen242 to displace thevalve232 and enable infusion or removal of inflation media. Following the desired volume of infusion or removal of inflation media, thevalve actuator234 may be proximally retracted, to enable the valve to close under its own bias. SeeFIG. 23.
• The opposingmagnets236 and238 may be utilized solely as a locating structure, such that an additional locking element (not illustrated) may be utilized to lock thecatheter240 on to theattenuation device230. This may be desirable if the strength of the bond formed between the two magnets is insufficient to keep theattenuation device230 coupled to thecatheter240 during the filling or removal steps. In addition, following deflation of theattenuation device230, thecatheter240 will generally require a relatively strong coupling to theattenuation device230 to retrieve theattenuation device230, as will be apparent to those of skill in the art in view of the disclosure herein.
• In accordance with one aspect of the present invention, the removal system is provided with one or more ultrasound transducers near a distal end thereof. An air filled attenuation device should strongly reflect an ultrasound signal, in a manner similar to the reflection achieved at an air-water interface. A removal system provided with a deflectable distal tip and ultrasonic capabilities should be able to navigate through the bladder to locate an attenuation device without the need for visualization. The removal system may additionally be provided with a grasping element, such as two or more opposing mechanical graspers, and/or a vacuum lumen, for attaching to the surface of the attenuation device using suction. Once attached, the attenuation device can be pierced and transurethrally withdrawn.
• In accordance with another aspect of the present invention, there is provided an attenuation device that may assume multiple shapes during the course of its use. For example, the attenuation device may be completely deflated for introduction and inflated to varying degrees after introduction. The attenuation device may be adjusted through the inflation/deflation of secondary or multiple containment cells for such purposes as ballasting or the addition of a diagnostic, therapeutic or signaling substance. This may occur through multiple uses of a single, or single uses of a multi lumen, multi ported structure or combinations thereof.
• In accordance with another aspect of the present invention, the delivery system and the removal system of the attenuation device or accumulator are two separate instruments. In another embodiment, the delivery system and the removal system are implemented using a single instrument. In yet another embodiment, there is provided one instrument having different distal ends for the delivery system and the removal system.
• In accordance with another aspect of the present invention, an endoscope may be used to launch and retrieve the device (i.e. attenuation device, accumulator, etc.).
• In accordance with another aspect of the present invention, the distal tip of the delivery system may be straight, pre-curved, malleable, or steerable (e.g., by pull wires) in order to facilitate delivery and/or release of the device.
• In accordance with another aspect of the present invention, the separation of the attenuation device from the fill tube may be accomplished using the wall of the urethra or neck of the bladder as a mechanically resistant body.
• In accordance with another aspect of the present invention, the delivery system may consist of a single tubular element, a series of concentric tubular elements, a series of non-concentric tubular elements, an extruded element, a spirally wound guidewire element, or any combination of the aforementioned elements arranged in a manner to provide the desired functions.
• In accordance with another aspect of the present invention, irritation concerns are addressed through the use of coatings or fillers to physically or chemically modify the attenuation device in whole or part in order to modulate characteristics such as lubricity and the ability to inhibit the deposition of materials present in the urinary tract. For example, substances such as sulfated polysaccharides may be used before, during, or after introduction to the patient. In addition, the use of a plurality of construction materials with unique surface properties may also be used for this purpose.
• In accordance with another aspect of the present invention, the attenuation device includes a portal that spans the distance from the internal aspect to the external aspect that allows for the location of an erodible substance that would allow for the deflation or deconstruction of the attenuation device after exposure to urinary tract conditions for a prescribed period of time. This approach may also be used for the programmed bolus release of single or multiple therapeutic, diagnostic or signaling substances from single or multiple chambers within the attenuation device.
• In accordance with another aspect of the present invention, the attenuation device is equipped with a valve/port that is programmable, self-regulating or responsive to stimuli, which may or may not be physiological. Telemetry, physical connection or remote signaling may be used to elicit a desired response.
• In accordance with another aspect of the present invention, the attenuation device accepts, captures, and/or translates physical forces within the urinary tract to energize a site within the attenuation device for the positive displacement of substances outside the boundary of the attenuation device in either continuous or bolus presentation.
• In accordance with another aspect of the present invention, there is provided a port/valve that is not associated with the sealing edge of the attenuation device.
• In accordance with another aspect of the present invention, there is provided an attenuation device that includes a thin,pliable safety tether332 long enough to extend from the attenuation device and exit from the meatus. SeeFIG. 24. The tether can be constructed of accepted materials such as those used in the manufacture of sutures, catheters and may also possess anti-microbial properties. In one embodiment, the distal end of the tether may be terminated with alightweight pendant334 of sufficient bulk to prevent ingress of the entire tether into the urethra. During normal use, the pendant may be temporarily affixed to the patient's pelvic region. The tether may be used to remove or deconstruct the attenuation device, and the tether provides the patient with the capability of instant removal of the attenuation device in the event the patient feels compelled to extract the attenuation device.
• In accordance with another aspect of the present invention, there is provided an attenuation device that is a chambered structure consisting of multiple subchambers for multiple functions. SeeFIGS. 25 and 25A-C. Theprimary attenuation device336 may or may not be fluidically connected to thesecondary device338. Thefluidic connection340 also acts as a tether with sufficient service loop to allow thesecondary device338 to be placed into the urethra while theprimary attenuation device336 remains untethered in thebladder63, located above thepubic bone69. During a urinary pressure spike, gas within theprimary attenuation device336 compresses proportionally with the external load. The compressed gas is then allowed to transfer to thesecondary device338, dwelling in the urethra, and causing a proportional expansion of thesecondary device338. The design of thesecondary device338 directs expansion in an outward radial direction, transverse to the longitudinal axis of the urethra, thus augmenting the natural inward radial contraction of the urethra. This type of “on demand” synchronous resistance augmentation may be much more effective than other forms of passive or patient controlled augmentation systems. Another benefit of this embodiment of the present invention is that the synchronous outward radial forces may help to positionally stabilize the secondary device within the urethra. Passive devices must maintain a constant retention capability (force or displacement of tissue) sufficient to resist the maximum expulsion forces at all times. This level of retention may lead to patient discomfort and cause long-term tissue damage.
• With reference toFIG. 25B, compression force (Fcomp) 342 equals the sum of ingress force (Fingress)344 and the egress force (Fegress)346. With reference toFIG. 25C, theintravesical pressure348 exhibits a rapid rise time and a rapid decay time. Thesecondary device pressure350 exhibits a rapid rise time and a delayed decay time.FIG. 26 illustrates the effect of an attenuation device on the intravesical pressure. Here, theintravesical pressure352 with the attenuation device exhibits delayed rise and decay times and remains below the leakage pressure of 80 cm H₂O. This is contrast to theintravesical pressure354 which exceeds the leakage pressure.
• With reference toFIG. 27, in one embodiment, theattenuation device66 is anchored to thebladder wall356. In another embodiment, shown inFIG. 28, theattenuation device66 is part of a transurethrally-placed dynamiccompliancy measurement catheter358. In other embodiments of the present invention, the attenuation device may resemble a small three-spoked automotive steering wheel, or a rotating toroidal space station. SeeFIG. 16A. The outer ring would contain the attenuation device; the inwardly radiating spokes would provide fluid conduits and mechanical support for the secondary device attachment. The attenuation device may also incorporate one or more shape holding super elastic wire members to aid in positional stability. The secondary device could resemble the distal tip section of a small diameter angioplasty device and be affixed to the central hub.
• In accordance with another aspect of the present invention, a secondary device inflation/deflation response can be design regulated. For example, it may be beneficial to inflate the secondary as quickly as possible, but induce a response lag in the deflation/inflation cycle to protect against a second cough, sneeze or sudden mechanical shock.
• In accordance with another aspect of the present invention, there is provided a pressure compensator or bladder trainer that can be implanted within a treatment site, such as, for example, the abdominal cavity, and be hydraulically or pneumatically connected to the bladder or be installed as a component of the bladder wall. The device would be constructed of a rigid external enclosure to shield the compressible elements from abdominal forces. The function of this embodiment would be not only to manage the transvascular pressure in treatment of a clinical insult, but also to introduce pressure waves either outside or inside the bladder in order to increase the muscle tone, compliance or affect the neuromuscular elements of the bladder.
• The embodiments of the present invention have been described for use in the human anatomy. As understood by those skilled in the art, the present invention is not limited to human use; rather appropriately scaled versions of the inventions disclosed herein can be used to provide clinical benefits to other animals, including but not limited to mammalian household pets.
• Certain embodiments of the present invention provide significant advantages over prior art devices. These advantages include but are not limited to: significant reductions in bladder dysfunction related events; the ability to retrain a bladder with other than normal compliance; no patient interaction required to operate or maintain the attenuation device; patient is allowed to void in a normal fashion; no infection conduit between the bladder and the distal end of the meatus; minimal sensation generated by the attenuation device; low cost to manufacture; cost effective solution for patient when compared to existing treatments; and ease of installation and removal for clinician.
• In accordance with one aspect of the present invention, there are provided devices and methods for measuring the dynamic compliance of the bladder. In one embodiment, a device can be used in combination with the fill tube/introducer to measure the dynamic compliance of the bladder. One lumen of the fill tube can be used to rapidly inflate the device, while pressure measurements of the bladder are made via a second lumen. In one embodiment, the volume is expanded by at least about 30 cc or 50 cc up to as much as 200 cc in a time period of from about 0.5 to 10 seconds to measure the dynamic compliance of the bladder.
• In accordance with another aspect of the present invention, there are provided methods and devices for the restoration of dynamic compliance of the bladder by retraining the bladder tissue by introducing pressure waves at a prescribed place and with prescribed characteristics.
• In accordance with another aspect of the present invention, there are provided methods and devices for the programmatic delivery of clinical therapeutics in association with defined pressure events. The present invention could be added to other intravesical devices, such as Foley catheters, intravesical infusers, such as those described in WO1998US0021368, filed Oct. 9, 1998, titled intravesical infuser (the disclosure of which is incorporated in its entirety herein by reference), or the ends of urethral stents to facilitate delivery, to treat multiple symptoms, or to enhance the performance of either device. For example, the attenuation device could work in combination with intravesical infusers, to time the release of medications relative to pressure events within the bladder.
• In accordance with another aspect of the present invention, there is provided an atraumatic method of measuring intravesical pressure without the need for any external connection by placing a pressure transducer and telemetry device within the attenuation device. This secures the transducer within the bladder and prevents the need to attach the transducer to the bladder wall.
• Embodiments of the present invention are not limited to intravesical devices, but also include devices and methods for controlling pressure transients in other organs of the body, as will now be discussed.
• With reference toFIG. 29, which shows atubular attenuation device66 in avessel360, one embodiment of the present invention is intended for use in cardiovascular applications to modulate pressure waves to protect the heart and/or the vasculature from being damaged due to exposure to the pulsatile forces of normal or extreme physiological events by reducing mean arterial pressure, systolic pressure and/or diastolic pressure. An attenuation device can be placed in the wall of the heart, within a major artery, or within the left atrial appendage of the heart (seeFIGS. 30A and 30B) to reduce risk of renal failure, stroke, heart attack, blindness. With reference toFIG. 30A, in one embodiment, an aircell attenuation device66 is positioned in the left atrial appendage of the heart. With reference toFIG. 30B, in one embodiment, a bellows-type attenuation device66 is positioned in the left atrial appendage.
• An attenuation device can be placed on or within the right side of the heart or in a pulmonary artery to reduce symptoms of primary permanent hypertension. An attenuation device can also be placed on the venous side of the vasculature system, such as within the wall of the vena cava or attached to a Greenfield filter within the vena cava to prevent portal hypertension and/or esophageal varices. An attenuation device, such as an air cell, can be attached to or encompass a stent for placement within the vasculature.
• In another embodiment, the attenuation device can be used in the gall bladder to modulate pressure contained therein. Pressure in the gall bladder may lead to undesired events such as the formation of stones or pain for the patient. An attenuation device can also be placed in the esophagus on the end of an NG tube to limit spasm. With reference toFIG. 31, anattenuation device66 can be placed in thebowel364 to treat irritable bowel syndrome, minimize Crohn's disease, cramping, or any other disorder resulting from peristalsis.
• In another embodiment, the attenuation device is used in the field of ophthalmology to support cranio-facial tissue during healing after a traumatic event or intraoptically as therapy for acute angle closure glaucoma. In yet another embodiment, the attenuation device is used in the field of orthopedics as an implantable or external system to protect against pressure waves and control the location of a healing bone after a traumatic event. In still another embodiment, the attenuation device is used in the field of otorhinolaryngology for the management of pressure waves in the sinus cavities, including in and around the ears, the nose and the throat. In another embodiment, an attenuation device is placed in the lung to treat disorders such as, for example, asthma, bronchial spasms or prevent damage from coughing in fragile lung tissues in emphysema sufferers, etc. In yet still another embodiment, an attenuation device is used to prevent Central Nervous System (“CNS”) problems such as, for example, head trauma, cerebral edema, hydrocephalus, etc. Here, the attenuation device can be placed in the epidural pocket under the skull.
• In accordance with one aspect of the present invention, there are provided air cell-like attenuation devices that are placed in the bladder and/or other organs of the body and filled with or comprise one or more compressible substances to provide pressure compensation. Additionally, active, programmable pressure compensators or generators are envisioned to monitor pressure events, respond in a predetermined fashion, and record or transmit that information outside the body. Additionally, a reliable, maintenance-free therapeutic delivery system is described to programmatically release or distribute an agent into an organ of the body using an erodible or deformable support matrix or material of construction, and/or a programmable or responsive valving system.
• In accordance with one aspect of the present invention, there is provided a compressible attenuation device having a valve that permits filling of the attenuation device through a filling device and yet resists deflation and/or additional filling of the attenuation device after the filling device is removed. In one embodiment, illustrated inFIGS. 36 and 37, thevalve80 is formed by twoparallel welds281,283 at the interface between two complementary surfaces—namely, theouter cover280 and theunderlying layer284. Thevalve80 is in effect a collapsible airflow passageway that remains in the collapsed position when the filling device is removed, thereby preventing deflation when the pressure within theattenuation device66 is greater than the pressure immediately outside the attenuation device and preventing the additional filling of theattenuation device66 when external pressure is greater than the pressure within theattenuation device66. Theouter cover280 and theunderlying layer284 function as two flat sheets that stick together regardless of the relationship between the internal attenuation device pressure and the immediate external pressure. In one embodiment (not shown), one or more adhesive materials or general locking mechanisms known in the art of medical device design can be used to shut thevalue80 upon removal of the filling device. It should be noted that once the filling device enters the valve at theentry point82, the attenuation device can be released and/or filled at any point inside of theentry point82, including but not limited to theinterface282 between thevalve80 and the inside of theattenuation device66. The valve of the present embodiment can be constructed according to the disclosure provided by U.S. Pat. No. 5,144,708, titled check valve for fluid bladders, issued Sep. 8, 1992, the disclosure of which is incorporated in its entirety herein by reference.
• In another embodiment, illustrated inFIG. 38, thevalve80 includes two duckbill structures that face opposite each other, thereby permitting filling of the attenuation device through a filling device while resisting deflation and/or additional filling of the attenuation device after the filling device is removed. Thevalve80 generally comprises atubular wall81, having anaperture82 in communication with aflow path298. The valve has two sets of first and a second duckbill valve leaflets86,88,290,292 that are attached to thetubular wall81. Upon removal of the inflation media source, the inflation media withinattenuation device66 in combination with natural bias of theleaflets86 and88 cause the leaflets to coapt, thereby preventing effluent flow of inflation media through theflow path83. In addition, the natural bias of theleaflets290 and292 cause the leaflets to coapt, thereby preventing the additional influx of media. It should be noted that theinternal section294 of the tube will have a pressure equal to the internal pressure of the attenuation device, whereas the external portion or flowpath298 will have a pressure equal to the immediate external pressure. A middle orneutral section296 of the tube is defined by the tubular wall and the two oppositely facing duckbill structures defined byleaflets86,88,290,292.
• In accordance with another aspect of the present invention, there is provided an implantable self-inflating pressure attenuation device that can inflate from a first, deflated configuration to a second, at least partially inflated configuration. Various transformable mediums can be used to inflate the housing of the attenuation device from a deflated configuration to at least a partially inflated configuration.
• With reference toFIGS. 47A-47C, in one embodiment, the transformable medium comprises afirst reactant432 and asecond reactant434. Here, the implantable self-inflating pressure attenuation device430 (shown in its first, deflated configuration) generally comprises afirst reactant432 and asecond reactant434, which are physically separated from each other. When thefirst reactant432 comes into contact thesecond reactant434, a chemical reaction occurs within theattenuation device430, thereby causing theattenuation device430 to transform into at least a partially inflated configuration (not illustrated).
• With reference toFIG. 47A, in one embodiment, thefirst reactant432 is contained within a balloon orcontainer436 that is entirely contained within and free to move within theattenuation device430. Thecontainer436 is generally impermeable toreactants432,434, and can comprise any suitable material known to those skilled in the art. The suitability of a material for thecontainer436 will depend on the chemical characteristics of thereactants432,434. In another embodiment, illustrated inFIG. 47B, thereactants432,434 are compartmentalized and separated within theattenuation device430 by awall438. Thewall438 is generally impermeable toreactants432,434, and can comprise any suitable material known to those skilled in the art. The suitability of a material for thewall438 will depend on the chemical characteristics of thereactants432,434. In yet another embodiment, shown inFIG. 47C, theattenuation device430 has acrease440. Thecrease440 separates thereactants432,434, and thereby prevents the inflation/expansion reaction from occurring until such inflation/expansion is desired and triggered by the user. In still another embodiment (not illustrated), thereactants432,434 are separated within theattenuation device430 by a peelable bond, fold, and/or the like, known to those skilled in the art.
• In one embodiment, the medium capable of transformation comprises gas generating compositions. Various compositions can be used to generate gas in accordance with this invention. One class of compositions is the combination of a base and an acid to produce carbon dioxide. The acid and base are combined in dry form and rendered reactive only when co-dissolved in water. Examples of suitable bases are water-soluble carbonate and bicarbonate salts, nonlimiting examples of which are sodium bicarbonate, heat treated sodium bicarbonate, sodium carbonate, magnesium carbonate, potassium carbonate, and ammonium carbonate. Nonlimiting examples of suitable acids are citric acid, tartaric acid, acetic acid, and fumaric acid. One presently preferred composition is a dry mixture of sodium bicarbonate and citric acid. Compositions containing more than one acid component or base component can also be used.
• Gas generation can be initiated various ways, such as, for example, contact with a fluid, temperature change, ignition, pH change, etc. In one embodiment, the amount of gas generated is equal to the amount of volume dissipated through the air cell, thereby allowing for constant volume device until the gas generating materials are exhausted.
• The amount and rate of gas production can be controlled by certain factors, such as, for example, the amount of reactive materials or reactants, the amount of gas entrapped in the structure, or the solubility of one or both of the chemicals in water, etc. In one embodiment comprising a wick and tablet systems, the available water as delivered by the wick to the tablet dissolves only a limited amount of the reactants and resulting reaction product(s). The reaction is thus limited by the solubility of the chemicals in the limited amount of available water. The rate of water delivery thereby controls the reaction rate. Some examples of the solubility of suitable reaction chemicals per 100 grams of water are as follows: sodium bicarbonate, about 10 g; citric acid, about 200 g; tartaric acid, about 20 g; and fumaric acid, about 0.7 g. The limited solubility and limited water delivery rate through the wick make it unnecessary to keep the acid and base separated either before or during use of the infusion device.
• It is further understood that a catalyst, another chemical species or one of the byproducts of the reaction can propagate the reaction and increase its speed. In the case of sodium bicarbonate and citric acid, the byproducts are carbon dioxide, sodium citrate, and water. A very small amount of water, such as, for example, 0.1 to 0.5 ml, can be used to start the reaction by dissolving the sodium carbonate and citric acid. Since water is produced in the reaction, the reaction speed increases until all of the reactants are exhausted.
• As a manufacturing aid, it may be desirable to add inert agent(s) to the reactant composition to aid in the tableting process and to keep the tablet intact during and after use. Examples of suitable tableting aids include but are not limited to polyvinyl pyrrolidone and anhydrous dibasic calcium phosphate, sold by Edward Mendell Co. (Patterson, N.J., USA) as EMCOMPRESS® Tableting aids can be eliminated for certain compositions with no loss of performance. One such composition is the mixture of sodium bicarbonate and citric acid.
• Chemical compositions that produce oxygen or other gases can also be used. A composition to generate oxygen in the presence of water is disclosed in U.S. Pat. No. 4,405,486, titled Method for Preparing granulated perborate salts containing a polymeric fluorocarbon, issued Sep. 20, 1983, the disclosure of which is incorporated in its entirety herein by reference. The controlled rate of wicking water into such a tablet, and the limited solubility of the constituents can control the rate of oxygen release in a manner similar to that of carbon dioxide in the systems described above.
• In another embodiment, the medium capable of transformation comprises peroxide and/or superoxide chemical systems. In certain embodiments, gas is generated by drawing an aqueous solution of a peroxide or superoxide into an absorbent tablet that contains an enzyme or catalyst which promotes the decomposition of the peroxide or superoxide to decomposition products including oxygen gas. In another embodiment, a solid peroxide or superoxide can be incorporated into the tablet, with oxygen generation being initiated by contact of the peroxide or superoxide with water. Hydrogen peroxide, for example, decomposes into water and oxygen, providing no hazardous reaction products after infusion of the liquid has been completed. Metal peroxides, such as, for example, lithium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, and zinc peroxide, etc., react with water to produce the metal hydroxide and hydrogen peroxide, which then decomposes into water and oxygen. Superoxides, such as, for example, sodium superoxide, potassium superoxide, rubidium superoxide, cesium superoxide, calcium superoxide, tetramethylammonium superoxide, etc., react with water to produce the metal hydroxide and oxygen gas directly. It will be noted that the production of hydrogen peroxide itself is particularly preferred.
• In one embodiment, a suitable tablet contains a water absorbent material to facilitate the wicking action, and the enzyme or catalyst in systems where enzymes or catalysts are used. Examples of water absorbents useful for this purpose include superabsorbent polymers, reconstituted cellulosic materials, compressed zeolite powder (Types 13X and 4A, both unactivated), etc.
• One example of a suitable enzyme is catalase. Lyophilized catalases are generally preferred. Catalysts effective for the decomposition include metals deposited on high surface area substrates, such as, for example, alumina, activated carbon, etc. Examples of suitable catalysts include platinum, palladium, silver, etc.
• Chemical reactants can also be used rather than enzymes or catalysts to decompose hydrogen peroxide. Examples of such reactants include but are not limited to potassium permanganate, sodium hydroxide, etc. It should be noted, however, that there are safety concerns associated with potassium permanganate and sodium hydroxide.
• As between enzymes and catalysts, enzymes provide a cost benefit for single-use systems. For reusable systems, however, catalysts are generally preferred. One significant advantage to the use of a hydrogen peroxide system with a catalyst is the ability to regenerate the system by drying out the tablet and adding more hydrogen peroxide solution to the water reservoir. Regeneration in this type of system is thus easier than regeneration of an absorbent tablet for a system that requires adsorbed gas.
• In another embodiment, the medium capable of transformation comprises chemical reactants that are used effectively to generate a gas to push a fluid from an infusion pump. In order to generate carbon dioxide, two or more reactive chemicals are mixed that, upon reaction, generate a gas. Preferably, one of the reactants is provided in liquid form, i.e., a liquid chemical, a solution, or the like, and another one of the reactants is provided as a solid. Either the liquid or the solid may comprise more than one reactive chemical. However, in one preferred embodiment, each of the liquid and the solid contain only one reactive species.
• Carbon dioxide is generally quite inert and safe at low concentrations. However, other gases could also be used, provided they are relatively inert and safe. For the purposes of the following discussion, it will be assumed that carbon dioxide is to be generated. As mentioned above, to generate the gas, at least two reactants are caused to come into contact. For ease of reference, the reactants will be referred to herein as a first reactant and a second reactant or a solid reactant and a liquid reactant, and particular sets of reactants will be referred to as reactant sets.
• First Reactant: Preferably, the first reactant is selected from a group consisting of carbonates and bicarbonates, particularly, Group I and II metal carbonates and bicarbonates (the “carbonate”). For example, in one embodiment, preferred carbonates include sodium bicarbonate, sodium carbonate, magnesium carbonate, and calcium carbonate. However, sodium bicarbonate, sodium carbonate and calcium carbonate are highly preferred, with sodium carbonate (or soda ash) being the most highly preferred. One desirable feature of sodium carbonate is that it is easily sterilizable. For example, sodium carbonate can be sterilized with heat, such as through autoclaving. This is preferable, since the infusion devices for use with the invention are designed for human use and it is safer to ensure that all of the components are sterile whether it is expected that they will come into contact with the patient or not. Other reactants that are sterilizable with heat, ethylene exposure, or exposure to ionizing radiation are equally useful.
• The carbonate can be either used as a solid reactant or can be dissolved in a solution to form a liquid reactant. In one preferred embodiment, the carbonate is used as a solid. The reason for this choice is that the carbonates are all solids and some are only sparingly soluble in water.
• Second Reactant: The second reactant is preferably an acid. Preferably, the acid is selected from the group consisting of acids, acid anhydrides, and acid salts. Preferably, the second reactive chemical is citric acid, acetic acid, acetic anhydride, or sodium bisulfate. Usually the second reactant is used as the liquid reactant. However, in the case of citric acid and sodium bisulfate, for example, the second reactant can also be the solid reactant. Nevertheless, the second reactant is generally more soluble in water than the first reactant and is, therefore, used to form the liquid reactant.
• Reactant Sets: A reactant set is based upon a variety of considerations. For example, the solubility of the first and second reactants are considered to determine which reactant should be used as the solid or liquid reactant. Also considered is the product of the reaction and its solubility. It is preferred that the products be CO2 gas and a soluble inert compound. Once these factors are considered, appropriate reactant sets can be constructed. For instance, in one embodiment, reaction sets such as those shown in Table I are preferred.

• 	TABLE I
  	Solid Reactant	Liquid Reactant
  	Sodium Carbonate	Citric Acid
  	Calcium Carbonate	Acetic Acid
  	Magnesium Carbonate	Citric Acid

• Additional details may be found in U.S. Pat. No. 5,992,700, titled controlled gas generation for gas-driven infusion devices, issued Nov. 30, 1999, and U.S. Pat. No. 5,588,556, titled method for generating gas to deliver liquid from a container, issued Dec. 31, 1996. Both of these patents are hereby incorporated by reference herein and made a part of this specification.
• In another embodiment, the method of producing gas is entrapped pressurized gas in a sugar or a porous molecular sieve. Generally, gas is liberated when the structure comes in contact with a fluid.
• In accordance with another aspect of the present invention, there is provided a method of delivering the implantable self-inflatingpressure attenuation device430 into the treatment site, such as, for example, the bladder. With reference toFIGS. 48A-48D, in one embodiment, thedelivery system450 includes abifurcated delivery tool452 and adelivery cannula454. Thetool452 has a fork-like shape and can be extended out and retracted into thecannula454. As illustrated, the bifurcations of thetool452 are spaced so as to squeeze or pinch thedevice430, thereby separating afirst portion444 of theattenuation device430 from asecond portion446, and thereby separating afirst reactant432 from asecond reactant434. Because thereactants432,434 do not come into contact with each other, the device remains in its deflated state, thereby facilitating the procedure of delivering theattenuation device430 to the treatment site, such as, for example, the bladder. In one embodiment, shown inFIGS. 48B and 48C, first andsecond portions444,446 of the deflated attenuation device are wound about itself along the axis of thetool452, thereby minimizing the volume of theattenuation device430, and thereby facilitating the delivery of theattenuation device430 into the treatment site.
• In accordance with another aspect of the present invention, there is provided a method of improving the dynamic compliance and/or contractility of the bladder.
• Histology: The mucosal of the bladder is composed of transitional epithelium. Beneath it is a well-developed submucosal layer formed largely of connective and elastic tissues. With reference toFIGS. 40A and 40B, the connective and elastic tissues of the bladder wall generally comprisemucosa394,elastin396,collagen398, andmuscle400.
• With reference toFIG. 40A, as in most tissues,collagen398 is arranged as a coiled or complex helical material within the bladder wall. Whilecollagen398 itself is not very elastic (distensible), the coiled configuration allows expansion of the collagen bundle. When the bundle is extended (seeFIG. 40B), the uncoiled collagen length becomes the limiting size. It is at this point that tension rises rapidly, analogous to the twisting of several strands of rope. When twisted, the combined strands shorten. The combined strands can be lengthened by untwisting without stretching any individual strand. As in other tissues, as the patient ages theelastin396 converts tocollagen398, reducing the compliance of thebladder63. External to the submucosa is thedetrusor muscle400, which is made up of a mixture of smooth muscle fibers arranged in a random, longitudinal, circular, and spiral manner.
• Physiology: The functioning of the bladder includes contributions from each of the layers of thebladder63 described above. One method of understanding the properties of the bladder over time is to evaluate a cystometrogram, which, in one embodiment, is generated by reasonably slow continuous filling of thebladder63.FIG. 41 illustrates a typical cystometrogram. Initially, during Phase I402 when thebladder63 is empty, elastic elements are not stretched. Here, the bladder is in a collapsed state and none of the materials within the wall are expanded. Accordingly, there will be no tension within the wall and pressure within the bladder will be relatively low. DuringPhase II404, as fluid fills the bladder, the walls unfold and elastic structures start to stretch. Now there is some tension and bladder pressure rises. As the bladder continues to fill, and the elastic tension continues to increase, the radius increases as well. From the Law of Laplace for a sphere, (P=2T/R), it will be noted that in order for pressure to remain constant the proportion between tension and radius must remain constant. DuringPhase III406, as the bladder capacity is reached, collagen and/or other less elastic materials have become unfolded and are themselves subject to stress. Since their modulus of elasticity is less than that for elastin and for the other elements on stress up to this point, the wall tension rises quickly and bladder fluid pressure rises steeply. A slight increase in volume or radius will now produce a rapid change in pressure. As this stretch occurs, neurological factors apply as afferent impulses from the bladder in response to stretch begin to occur with a significant frequency.
• Therapeutic Benefits, Methods of Improving the Dynamic Compliance of the Bladder, Methods of Improving the Contractility of the Bladder: Based on demonstrations by Solace, Inc. it is believed that the removal of high frequency, repetitious insults to the bladder wall for a 5 day to 180 day period of time increases the dynamic compliance of the bladder and reduces symptoms of incontinence by: precluding/reducing the stretch of elastin fibers; reducing of the conversion of elastin fibers into collagen; allowing the “stretched” muscles of the bladder wall to shorten, thereby improving compliance and bladder wall contractility; removing pressures exerted on the pelvic floor and connective tissues, allowing retraining and healing, increasing urethral resistance; placing the attenuation device in the bladder provides passive resistance to the bladder neck and bladder wall, allowing the muscles to strengthen. These and other therapeutic benefits could last up to about 30 days to about one year. One additional benefit of attenuation and/or improving bladder compliance includes improved flow during voiding (i.e. method of improving flow during voiding by “smoothing” the pressure within the bladder). Abdominal straining, resulting in a raised abdominal pressure Pabd and, therefore, an increased intravesical pressure is not often employed in normal voiding, nor is it usually as efficient as detrusor contraction in producing voiding. If, however, the detrusor contraction is weak or absent abdominal straining may be the only available way of voiding and may then become of primary importance.
• The detrusor pressure is not by itself a measure of the strength of the detrusor contraction. A satisfactorily contracting detrusor can produce either a high detrusor pressure and a low flow-rate, or a low pressure and a high flow-rate. The tradeoff between the pressure generated and the flow produced results from the force/velocity relationship characteristic of any contracting muscle. Consequently, for patients with low dynamic bladder compliance, any pressure changes during flow can significantly decrease flow rates. For patients that have weak detrusor contractions and/or those that “bear down” for force urine out of the bladder, sometimes referred to “Val Salva voiders,” there is great pressure fluctuations within the bladder during voiding, resulting in reduced flow rates. By attenuating pressures within these patients via an attenuation device, improved flow can be achieved.
• Another benefit of attenuation and/or improving bladder compliance includes improved urethral closure pressures. Changes in abdominal pressure affect not only the intravesical pressure but also the urethra, proximally by direct mechanical action. The result is that when the abdominal pressure rises, as during straining or a cough, the urethral pressure discussed above also rises. The maximum urethral closure pressure therefore does not diminish, and may even increase. This represents a natural defense against leakage during stress. This process is enhanced by the attenuation of intravesical pressures within the bladder, with full exposure of the urethra to increased abdominal pressures.
• Another benefit of attenuation and/or improving bladder compliance includes improving the symptoms of benign prostatic hypertrophy (“BPH”). As the prostate enlarges, flow rates are reduced and residual volumes increase. The symptoms of low flow are increased as the increased intravesical pressure causes a decrease in the compliance of the bladder wall, bladder muscles elongate, elastin converts to collagen in the most severe cases), making it even more difficult for the bladder to “push” the urine through the restricted opening of the prostate. As this cascade continues, the symptoms of benign prostate hyperplasia increase. Placement of an attenuation device in the bladder reduces symptoms of BPH by improving flow, increasing the compliance of the bladder wall, removing high pressure insults to the bladder wall, and allowing the bladder wall muscles to shorten, all permitting the bladder to more effectively “push” the urine through the urethra and prostate. In one embodiment, the attenuation device in the bladder reduces the symptom of BPH by attenuating increases in pressure within the bladder by reversibly reducing its volume in response to the pressure increases. For example, in one embodiment, the attenuation device reduces its volume by at least 5%. In another embodiment, the attenuation device reduces its volume by at least 10%. In yet another embodiment, the attenuation device reduces its volume by at least 25%.
• Conformable Device: Patients generally experience pain and irritation when any foreign object is either wholly or partially in the bladder or bladder neck. With reference toFIG. 42, this pain can occur when the bladder or bladder neck has collapsed onto theforeign object408, perhaps within a fold of the bladder; the pressure exerted on the bladder wall by focal points on the device creates pain and irritation. This pain is typically more acute when the patient is in the horizontal position.
• With reference toFIG. 43, to eliminate pain and irritation of the bladder and bladder neck when the bladder collapses on to any device (wholly or partially in the bladder and bladder neck), the shape of theattenuation device410 can change to conform to the bladder wall in order to maximize the surface area of the attenuation device in contact with the bladder wall so as to dissipate the pressure over as large a surface area of the bladder wall as possible, and thereby prevent the focal points that cause trauma, pain, or irritation to the bladder. In one embodiment, the attenuation device has a compressible wall, thereby resulting in a conformable device where the medium (e.g., gas) within the device can move out of a fold in the bladder wall to reduce trauma. Examples ofsuch attenuation devices410 include but are not limited to: attenuation device having 15 cc of air in a container that is capable of holding 30 cc of volume; Foley catheter or other catheter having an inflatable anchoring balloon; drug delivery infuser; J stent; etc.
• FIGS. 39A-D illustrate attenuation (i.e. pressure reduction) with various attenuation device air volumes. The data for these graphs were generated using a bench top bladder simulation program. Here, the maximum spike pressure is 2.0 psi. The spike event duration is approximately 40 ms, which is approximately equivalent to the duration of a coughing or sneezing event. With reference toFIG. 39A, a test was conducted with a 250 mL rigid plastic container filled with synthetic urine. A regulated pressure of 2.0 psi was introduced into the container via a controlled solenoid valve. A pressure transducer detected the pressure rise. Here, the pressure rise time (Tr) of thecontainer pressure422 to reach 2.0 psi was approximately 40 msec. With reference toFIG. 39B, a similar test was conducted on a 250 mL rigid plastic container. Here, an attenuation device filled with 15 mL of air was placed inside the container willed with synthetic urine. Here, the Tr of thecontainer pressure424 to reach 2.0 psi was approximately 195 msec. Thus the attenuation device slowed the rise time by 4.8×. During the spike event (i.e. when time equaled 40 msec), the pressure inside the container reached 0.7 psi (vs. 2 psi), resulting in a 65% reduction of pressure vs. baseline. With reference toFIG. 39C, a similar test was conducted; the only difference being that the attenuation device was filled with 25 mL of air. Here, the Tr of thecontainer pressure426 to reach 2.0 psi was approximately 290 msec. Thus the attenuation device slowed the rise time by 7.25×. During the spike event (i.e. when time equaled 40 msec), the pressure inside the container reached 0.5 psi (vs. 2 psi), resulting in a 75% reduction of pressure vs. baseline. With reference toFIG. 39D, a similar test was conducted; the only difference being that the attenuation device was filled with 30 mL of air. Here, the Tr of thecontainer pressure428 to reach 2.0 psi was approximately 340 msec. Thus the attenuation device slowed the rise time by 8.5×. During the spike event (i.e. when time equaled 40 msec), the pressure inside the container reached 0.4 psi (vs. 2 psi), resulting in an 80% reduction of pressure vs. baseline.
• FIGS. 44A-D shows pressure vs. time curves generated by a bench top bladder simulator.FIG. 44A shows the baseline pressure-time curve without an attenuation device.FIG. 44B shows the pressure-time curve with an attenuation device having a 15 cc air volume.FIG. 44C shows the pressure-time curve with an attenuation device having a 25 cc air volume.FIG. 44D shows the pressure-time curve with an attenuation device having a 30 cc air volume.
• Algorithm(s) for Measuring Leak Point Pressures: Typical measurement of a patients leak point pressure is taken with pressure catheters in the bladder and in the rectum. The patient tightens the abdominal and pelvic muscles (valsalva) to increase the external pressure exerted on the bladder. At the time when the test administrator identifies visually that leakage has occurred, a button is pressed, and the most recent pressure data points are recorded. Typical urodynamic equipment in use today measures2 to35 data points per second. Given the time delay from when leakage occurs and when leakage is evident to the test administrator, and the fact that pressure decreases when leakage occurs, one embodiment of a more accurate method of measuring leak point pressure involves measuring pressure at the rate of 1000 pts per second, and programming or setting a computer to look at the prior 5/3/2/1 second(s) and to look for the peak-generated pressures when the clinician presses the “leak” button (i.e. a button on or in communication with the computer that the clinician pushes upon seeing or detecting leakage).
• In accordance with another aspect of the present invention, there is provided a method of attenuating pressure changes in the bladder by introducing one or more low permeability gases and/or fluids with higher vapor pressures into an attenuation device. A lower permeability and higher vapor pressure gas or fluid usually has a higher density than air or water, respectively. The solubility of the gas or fluid in urine is commonly very low. With reference toFIG. 49, the illustrative embodiments described herein show anattenuation device66 with one high vapor pressure gas or fluid. However, it will be understood that theattenuation device66 can have one or more high vapor pressure gases and/or fluids, or combinations thereof. Outside the body, the atmospheric pressure (P_a) is equal to the partial pressure of air (P_Air). The pressure within the bladder (P_b) is approximately equal to P_a; however, in practice, P_bis slightly higher P_a. For example, if P_ais 14.7 psi or 1 atm, then P_bcan be approximately 14.85 psi (i.e. 14.7 psi+0.15 psi). There is a usually a pressure gradient from P_bto P_awithin thetissues464 of the body moving from thewalls466 of an individual'sbladder468 to thesurrounding atmosphere460 outside theskin462. Since P_bis greater than P_a, the pressure gradient results in the transfer of gases from the inside the body, such as, for example, from within the bladder outward through the pores in theskin462 of an individual. The total pressure within the attenuation device (P_T) (i.e. within theouter wall470 of the attenuation device66) is equal to the sum of partial or vapor pressures of the high vapor pressure gas or fluid (P_HD) and P_Air.
• With reference toFIG. 49, in one embodiment, theattenuation device66 comprises anouter wall470 and a high vapor pressure gas or fluid that generally has low permeability through theouter wall470. In one embodiment, thewall470 comprises a material, such as, for example, polyurethane, that is characterized by low permeability for the high vapor pressure gases and vapors and moderate to high permeability for air. Examples of suitable high vapor pressure gasses or fluids include, but are not limited to: sulfur hexafluoride hexafluoroethane; perfluorocarbons ranging from perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, perfluoroheptane, perfluorooctane, perfluorodecalin, octafluoropropane, decafluoro-n-butane, perfluorooctylbromide to perfluoroperhydrophenanthrene; and inhaler propellants like heptafluoropropane and tetrafluoroethane.
• With continued reference toFIG. 49, air is dissolved in the urine in the bladder. As explained above, P_bis slightly greater than P_Air. Here, P_T=P_bP_HD+P_Air. In one embodiment, if the material of theattenuation device66 does not allow the higher vapor pressure gas to permeate through thedevice66, air is driven into the attenuation device until the partial pressure of air in the urine matches the partial pressure of air in the attenuation device. In another embodiment, if a high vapor pressure fluid with a vapor pressure (P_HD) greater than the bladder pressure and a low permeability rate through the attenuation device wall were put into theattenuation device66, air would be driven into thedevice66 until the partial pressures of air are equal in theattenuation device66 and in the urine. With a reservoir of fluid in theattenuation device66 more vapor could be evaporated when P_bdecreases and vapor would condense when the P_bincreases, thereby resulting in a constant pressure system.
• In one embodiment, where the average P_bis known, a constant volume system is achieved by using a wall material that is generally taut and rigid in structure, such as, for example, silicone, polyurethane or any derivative thereof, that allows permeability to air but not to the selected high vapor pressure gas or fluid/vapor. Here, theattenuation device66 is placed deflated into the bladder. A mixture of air and higher vapor pressure gas or fluid are injected into theattenuation device66 so that the P_HDmatches the average pressure of the bladder (P_b) minus the atmospheric pressure (P_a). If there is no loss of the higher vapor pressure gas or fluid/vapor through the attenuation device wall, an equilibrium point is reached when the partial pressure of air in the attenuation device matches the partial pressure of air in urine. If the volume of gas in theattenuation device66 puts no tension on the wall of the attenuation device, then the vapor or partial pressure of the higher vapor pressure gas or vapor equals the average bladder pressure minus the atmospheric pressure and the partial pressure of air in the attenuation device equals the partial pressure of air in the urine.
• It will be noted that the pressure in the bladder typically ranges from 0 to 2 psi and is a function of the lifestyle of the individual. In one embodiment, comprising a constant pressure system, the wall of theattenuation device66 can be designed to provide tension to control volume changes due to pressure variations in the bladder. For example, in one embodiment, if theattenuation device66 were designed to match an average bladder pressure of 0.15 psi but the individual's bladder pressure is higher, air would be forced out of theattenuation device66 until the partial pressure of air balances between the attenuation device and the urine or all of the air is forced out of the attenuation device. If the bladder pressure were lower, air would be driven into the attenuation device until the tension on the walls of the attenuation device results in the internal partial pressure of air equaling the bladder partial pressure of air.
• Having thus described certain embodiments of the present invention, various alterations, modifications and improvements will be apparent to those of ordinary skill in the art. Such alterations, variations and improvements are intended to be within the spirit and scope of the present invention. Accordingly, the foregoing description is by way of example and is not intended to be limiting. In addition, any dimensions that appear in the foregoing description and/or the figures are intended to be exemplary and should not be construed to be limiting on the scope of the present invention described herein.

Claims (1)

What is claimed is:

1. A device for treating symptoms of a urinary tract dysfunction, comprising a compressible attenuation device having an expanded volume within the range of from about 1 cc to about 400 cc, and a valve for permitting filling of the attenuation device through a filling device; wherein the valve has a first pair of complementary surfaces for resisting deflation of the attenuation device, and a second pair of complementary surfaces for resisting additional filling of the attenuation device when the attenuation device is exposed to an external pressure which is greater than an internal pressure within the attenuation device.

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