Devices and methods for attenuation of pressure waves in the body

[0001] (Background of invention) Field of invention The present invention generally relates to the following systems of the human body: cardiovascular system, lung, kidney / urinary system, gastrointestinal system, liver / bile duct system, gynecological system, central nervous system, musculoskeletal system, otolaryngology, and ophthalmology. It relates to methods and devices for attenuating and / or diverting transient pressure waves of relatively incompressible material in internal organs including, but not limited to, systems. [0002] In certain aspects, the invention relates generally to the fields of urology and gynecology, and more particularly to the treatment of urethral disorders caused by sudden fluctuations in intravesical pressure. More specifically, in this aspect of the invention, methods and devices for diagnosing and treating dysuria such as incontinence, urinary urgency, pollakiuria, interstitial cystitis, irritable bladder syndrome, neurogenic bladder, etc. Provided. [0003] Description of related technology Pressure waves are known to propagate through incompressible fluids within various organs within the body. These pressure waves can be breathing from the beating heart or lungs, peristaltic movements of the gastrointestinal (GI) ducts, internal events such as body muscle movements, or coughing or laughing, body trauma, body movements against gravity, etc. It can be caused by several events, including external events. Propagation of these pressure waves increases as the elasticity of surrounding tissues and organs, sometimes referred to as compliance, decreases. These pressure waves have many undesired effects, from discomfort to stress on organs and tissues, fluid leaks such as urinary incontinence, renal failure, stroke, heart attack, and blindness. [0004] Pressure accumulators and wave diffusers are a type of device that can modulate pressure waves in a variety of dissimilar settings. Accumulator technology is well known and has been used in aircraft, manufacturing equipment, water supply and distribution hydraulic systems since the 1940s. Common types of accumulators include bladder accumulators, piston accumulators, non-separators (air over fluids), and weight accumulators. [0005] The wave diffuser also affects the transmission of pressure waves in incompressible systems in various settings. The function of such a diffuser impedes the progress of the pressure wave and distributes the energy of the wave in so many directions that the perfect state of the uniform wave surface and the resulting action are destroyed. That is. The wave diffuser can be used to protect a particular area from the impact of the wave surface. [0006] Urethral disorders are a common problem in the United States and around the world, affecting people of all ages, both physiologically and psychologically. Urethral disorders have several causes, including birth defects, illness, injury, aging, and urinary tract infections. [0007] In light of the above, several attempts have been made to address these obstacles. One such attempt involves using the indwelling catheter connected to the collection bag by a clamping device on the indwelling catheter. However, indwelling catheters have some drawbacks. For example, there is a risk of indwelling catheter-related infections, where bacteria or other microbes pass directly through the bladder. For this reason, indwelling catheters can only be used for a relatively short period of time. In addition, indwelling catheters and accompanying collection bags are unattractive to most patients. [0008] Attempts to resolve urinary incontinence include the use of artificial urethral valves. One such prior art valve utilizes an inflatable cuff that is inserted around the outside of the urethra. Conventional urethral valves also have a number of drawbacks. One drawback of these valves is that they generally require surgery to install, and some prior art valves must be operated externally, so these valves are manually operated. Depends on the intervention of. [0009] It is also known to use an intraurethral valve. Typical urethral valves of the prior art also generally require manual intervention. Another problem associated with prior art urethral valves is that the valve can slip into the bladder or be pushed out of the urethra. Again, there is a risk of infection associated with many such valves, but it is because these valves often extend to the urethra and / or have some of the equipment outside the urethra and the microorganisms This is because it moves into the bladder. [0010] Electrical stimulation therapies, including rectal, intravaginal, and external, have been attempted to condition the muscles that support the bladder and urethra and stimulate their nerves. This therapy requires a large number of long-term treatments, and stopping the treatment generally diminishes any benefit from the therapy. [0011] Current surgical incontinence procedures generally focus on increasing urethral flow resistance. Conventional surgical interventions include bladder neck traction and bulk (collagen) injection. While these procedures can be clinically effective for some patients, their clinical outcomes can vary significantly, their costs are relatively high, and their surgery can be complicated. There is a problem, and any effect may not last long. [0012] There are several medications for urethral conditions, including overactive bladder. These drugs include oral medication (systemic) and drugs delivered directly to the bladder. These drugs generally have side effects, are ineffective and have a high prevalence. Oral administration generally does not immediately relieve symptoms and has side effects such as dry mouth and constipation. For drugs delivered directly to the bladder, continuous or intermittent catheter placement is often required to introduce the therapeutic agent at a clinically appropriate time. [0013] The objectives of the treatments described so far have focused on either increasing urethral resistance, temporary arrest or absorption of total urethral flow, or relaxation of the detrusor muscle to minimize unwanted contractions. ing. The shortcomings and limitations of prior art treatments are numerous and include the following: Excessively high levels of patient interaction are generally required to operate and / or maintain the device, especially in older patients and patients with physical or mental disabilities; Limited clinical efficacy; Urine outflow is restricted; It makes the patient uncomfortable and has side effects; Urethral and bladder infections related to the device used; It includes matters such as being relatively expensive when compared to non-clinical solutions (such as diapers and pads). [0014] These prior art approaches do not address the reduced dynamic compliance that results in increased intravesical pressure. [0015] (Outline of the invention) Embodiments of the invention generally provide methods and devices used in the body to measure and / or attenuate and / or control pressure waves of incompressible fluids within body organs and tissues. Embodiments of pressure accumulators include single-unit or multi-units of single-chamber or multi-chamber equipment, bulkhead structures, bellows of various shapes, active and passive mechanical structures capable of managing energy. , And instrumentation for clinical use of the device. [0016] A particular embodiment of the invention is the urethra by increasing the effective dynamic compliance of the bladder or other anatomical structure or system by adding compliant components to the semi-compliant or non-compliant system. Overcome the limitations of the methods and devices described above for treating disorders. The methods and devices of embodiments of the present invention incontinence by reducing transient pressure changes, including impact pressure spikes in the urinary tract, due to some common movements such as coughing, jumping, laughing, and squeezing. Eliminates or alleviates the symptoms of patients suffering from one or more symptoms of overactive bladder, neurogenic bladder, pollakiuria, urinary urgency, interstitial cystitis, and other urinary tract disorders. Moreover, the devices and methods of embodiments of the present invention minimize the likelihood that the patient will suffer from problems such as fixation, irritation, or infection to the patient. In addition, the devices and methods of embodiments of the present invention can address multiple conditions that affect the same patient. Moreover, the devices and methods of embodiments of the present invention are simple and do not necessarily require cystoscopy to place and / or remove the device. [0017] According to one aspect of the invention, there is provided a method of attenuating pressure and / or diverting pressure waves within an anatomical structure. The method includes placing the attenuator in contact with the body cavity and exposing the attenuator to changes in pressure within the body cavity. This pressure change then decays. In general, a pressure change is an increase in pressure. In one embodiment, the placement step comprises placing an attenuator within the body cavity. In one application of the invention, the body cavity is within the bladder. [0018] Attenuating the increased pressure is preferably achieved by reducing the volume of the attenuator. The volume reduction preferably responds to an increase in pressure. In one embodiment, the attenuator includes a compressible wall that compresses in response to intravesical pressure to reduce the volume of the attenuator, thereby attenuating the intravesical pressure spike. [0019] According to another aspect of the invention, there is provided a method of treating stressful or urinary urgency incontinence, or other urethral dysfunction. The method includes identifying a patient who presents with symptoms of urethral dysfunction and positioning a compressive pressure attenuator within the patient's bladder. The positioning step preferably involves carrying the attenuator urethrically to the bladder on the deployer. This method can further include removing the attenuator from the bladder. The compressible pressure attenuator preferably keeps the intravesical pressure lower than the urethral leakage pressure, generally about 80 cmH.₂Approximately 120 cmH from O or less₂It is within the range up to O. [0020] According to another aspect of the invention, an apparatus for treating urethral dysfunction is provided. The device includes a compressible attenuator whose inflated volume is in the range of about 10cc to about 50cc, which is about 80cmH.₂Under O pressure (80 cmH₂120cmH from O₂In the range of O), it can be compressed to about 80% or less of its expanded volume. In one embodiment, the attenuator comprises an inflatable balloon. In an alternative embodiment, the attenuator comprises a compressible bellows. In both embodiments, the attenuator can further include a pressure transducer and an expansion port. Embodiments with an expansion port preferably further include a valve to inflate the attenuator within the bladder. [0021] [0021] According to another aspect of the invention, a method of treating a patient is provided. This method involves preparing a compressible attenuator that can be moved from a first introductory configuration to a second embedded configuration. This attenuator is introduced into the body during the first configuration and transforms into the second configuration within the body. The attenuator then attenuates the pressure spikes in the body by reversibly reducing the volume of the attenuator in response to the pressure spikes. [0022] In one application, the introduction step involves introducing an attenuator transurethrally into the bladder. The deformation step involves inflating the attenuator at least partially. Alternatively, the deformation step involves changing the attenuator under its own pias. The damping step preferably comprises reducing the volume of the attenuator by at least about 5%, preferably at least about 10%, and optionally at least about 25% to dampen the pressure spikes. This method can further include removing the attenuator from the body. [0023] Yet another aspect of the invention provides a method of assessing the dynamic compliance of the bladder. The method includes injecting a volume of liquid into the bladder and measuring the intravesical pressure of the bladder. The infusion step can include injecting a volume of at least about 50 cc over a period of about 10 seconds or less. In one application, the infusion step is implemented by the first lumen of the catheter and the measurement step is implemented by the second lumen of the catheter. [0024] Other features and advantages of the present invention will be appreciated by those skilled in the art in light of the detailed description of preferred embodiments set forth below, when the accompanying drawings and claims are also taken into account. [0025] (Detailed description of preferred embodiments) Embodiments of the invention are directed to methods and devices for measuring and / or attenuating and / or diverting transient pressure waves of relatively incompressible material within body organs. The exemplary embodiments of the invention discussed below generally relate to the fields of urology and gynecology, and more specifically to the treatment of urethral disorders exacerbated by sudden fluctuations in intravesical pressure. However, as will be readily understood by those skilled in the art and as described below, the invention is not limited to the fields of urology and gynecology, and the methods and devices of embodiments of the invention further include pressure transients. Can also be used in other organs of the body to attenuate and / or divert, or to reversibly block organ lumens. [0026] Embodiments of the present invention attenuate transient intravesical pressure, including pressure spikes on the urethra. During frequent transient pressures, the bladder suffers from several factors, including pelvic skeletal structure, compressive loads that contract the tissues that define the bladder, or poor compliance of the bladder's muscle system, nerves, or connective tissue. This creates a relatively non-compliant environment. Factors that result in poor bladder compliance are aging, anatomical abnormalities, or trauma to the pelvic and abdominal structures. [0027] Urine consists primarily of water and is poorly compressed in the typical pressure range within the human bladder. The relationship between maximum urethral pressure and bladder pressure in normal bladder urination has been clarified. Urethral relaxation occurs shortly after detrusor contraction, with intravesical pressure exceeding urethral pressure. See, for example, Figure 1. [0028] The bladder has two mechanical functions: 1) low pressure storage and 2) high pressure urination. During the storage or filling period, the bladder receives urine flowing from the kidneys. Bladder compliance is defined as the ratio of volume change to pressure change, and bladder static compliance is measured during a typical micturition hydraulic assessment. The static compliance index is measured by filling the bladder to an intravesical pressure measurement and equilibrating the pressure for about 60 seconds. The static compliance index is calculated by dividing the bladder capacity by the detrusor muscle pressure at the end of filling. Normal bladder static compliance is 21-100ml / cmH₂It will show a value between O. Bladder with low static compliance generally has a compliance index of 20 ml / cmH.₂It becomes less than O. Bladder with low static compliance is generally poorly inflated and has high pressure at the end of filling. See Figure 2. Bladder steady-state compliance is used to diagnose patients with naturopathic problems such as lower or upper motor neuron damage or multiple sclerosis. In addition, this steady-state compliance of the bladder is sometimes used to investigate incontinence problems, including urinary urgency, pollakiuria, and cystitis. [0029] Intravesical pressure spikes are generally caused by volumetric displacement of tissue in response to gravity, muscle activity, or rapid acceleration phenomena. Insufficient bladder compliance and frequent inclusion of urine in the bladder minimizes fluid pressure attenuation of more frequent pressure waves and increases intravesical pressure that is transmitted directly to the bladder neck and urethra. , May cause detrusor contraction, or may not cause detrusor muscle contraction. Under these conditions, the urethra acts as a volumetric pressure relief mechanism, allowing a proportional volume of fluid to escape from the bladder and reducing the intravesical pressure to an acceptable level. The urethra has a maximum urethral pressure value, and when the bladder pressure exceeds the maximum urethral pressure, fluid will escape from the bladder. Under these conditions, bladder and / or bladder neck and / or triangular nerve receptors can cause detrusor contraction, resulting in urethral contraction (frequent urination) or can be contained without urinary bladder. It is sexual (urinary urgency), or the bladder pressure may exceed the maximum urethral pressure and fluid may escape from the bladder (imminent urinary incontinence). Under these conditions, waves that collide with and / or dilate the bladder wall can cause significant pain in patients with cystitis. [0030] The inventors of this application have found that in the majority of patients suffering from urethral disorders such as pollakiuria, urinary urgency, incontinence, and cystitis, bladder compliance with steady causes and / or triggers for bladder dysfunction. Not noticed a decrease in overall dynamic bladder compliance. These patients often have a compliant bladder under steady-state conditions, but when exposed to external pressure, for example for as short as less than 5 seconds, sometimes less than 2 seconds, or even less than 0.5 seconds. In addition, it can become dynamically non-compliant. Poor bladder dynamic compliance is often caused by some of the same conditions as poor steady-state compliance, including aging, use, swelling, childbirth, and trauma. The anatomy of the bladder, which involves the diaphragm, stomach, and uterus (in women), exerts external pressure on the bladder during conversation, walking, laughing, sitting, moving, turning, and turning over. [0031] Figure 3 shows the relationship between intravesical pressure and maximum urethral pressure in patients suffering from stress incontinence due to lack of dynamic bladder compliance. When a patient coughs (or is subject to some other stress), spikes in bladder pressure will occur if the bladder does not have sufficient dynamic compliance within its frequency range. 120cmH₂Intravesical pressure spikes above O were recorded hydraulically during micturition during coughing, jumping, laughing, or sneezing. Leakage occurs when the bladder pressure exceeds the maximum urethral pressure. To retain urine during the intravesical pressure spike, the incontinence person's urinary retention resistance must exceed the pressure spike. Urinary retention resistance is simplified as the sum of the outflow resistance contributions of the urethra, bladder neck, and opening. For female patients, it is generally considered that the maximum resistance component is provided by the urethra. One measure of urinary resistance is the micturition hydraulic measurement of urethral leakage pressure. Urethral leakage pressure in incontinent people is generally 80 cmH₂Less than O. Sufficient reduction in urinary retention resistance is due to several factors, including decreased blood flow in the pelvic region, decreased tissue elasticity, neuropathy, decreased urethral muscle tone, and tissue trauma. [0032] Dysuria, such as urinary urgency and pollakiuria, also known as overactive bladder, interstitial cystitis, causes motor neurons to signal the brain due to a rapid increase in pressure or volume in the bladder or other hypersensitivity conditions. , Which occurs or exacerbates when a cascade of events required for urination is initiated. External pressure on the bladder can lead to detrusor contraction, which can lead to urinary urgency, pollakiuria, or incontinence. See Figure 4. Urinary disorders such as interstitial cystitis and irritable bladder conditions are chronic inflammatory conditions of the bladder wall, including pain as well as urinary urgency and / or pollakiuria symptoms. Therefore, the problem of functionally non-compliant bladder pressure spikes can be exacerbated by the effects resulting from bladder contraction and urethral relaxation, i.e., higher cognitive center stimulation, which occur at about the same time. Bladder contraction and urethral relaxation are generally slightly behind the onset of spikes and, in unexpected cases, can result in greater leakage than would be caused by pressure spikes alone. [0033] Embodiments of the present invention provide methods and devices for measuring and recording dynamic bladder compliance. One method of determining dynamic compliance involves rapid injection of a volume of fluid into the bladder while making an immediate measurement of bladder pressure. Its volume is greater than 50cc, preferably greater than 100cc, more preferably greater than 200cc. The injection rate will be less than 10 seconds, preferably less than 5 seconds, more preferably less than 2 seconds. One embodiment of the invention comprises a two lumen catheter placed in the bladder, where the compliant balloon is rapidly filled with a non-compliant substance such as saline, which is such a catheter. Infused through one lumen. The resulting intravesical pressure is measured from the other lumen of this catheter. This infusion can be performed by a syringe, mechanically assisted syringe, or pump. [0034] Additional embodiments provide methods and devices for processing and / or compensating for reduced bladder dynamic compliance. In another embodiment of the invention, a device with a compressible element is placed within the human bladder so that the compressible element can act as a pressure attenuator to attenuate transient pressure events. Gases such as air, carbon dioxide, and nitrogen are highly compressible in the pressure range generally applied to the human bladder, so these gases can be used in air chamber-type devices inserted into the bladder. Moreover, these gases are significantly more compliant than the adjacent environment when compared to the tissues surrounding urine. When an unpressurized gas whose volume decreases proportionally is added, it acts as a slow spring that exists in series with the natural fluid circuit of the urethra. [0035] In another embodiment of the invention, compressing a sealed volume of air produces heat that is dissipated into a relatively infinite heat sink in the body. The rest of the energy absorbed by the compressed air is simply returned to another less frequently fluid circuit as the gas expands as the surrounding tissue returns to its initial position. With the addition of sufficient local compliance, transient intravesical pressure spikes can be effectively dampened to levels below the patient's leak pressure so that they do not need to be mitigated by urine volume displacement and / or bladder contraction. The stimulation of the signal to the brain that causes it is prevented. [0036] One pressure compensator of the present invention placed in the human bladder is described below. This device attempts to release the bladder and leave it in the bladder for several hours to a year, one week to six months, or one to three months. It is a thing. This device is a small elastomeric air chamber whose relaxed (non-tensioned) volume is between 1 and 500 cc, more preferably between 1 and 100 cc, and more preferably between 3 and 25 cc. .. The device is a single component, but can consist of two or more sub-components. The device has a substantially uniform wall thickness between 0.64 cm and 0.00025 cm (0.25 inch to 0.0001 inch), more preferably between 0.0013 cm and 0.013 cm (0.0005 inch to 0.005 inch), but with significant variation. It can be designed and still perform its intended function. In the above-described embodiment, a device having an air chamber floating in the bladder has been described. In other embodiments of the invention, the air chamber or similar device can be surgically secured to the bladder wall using sutures, staples, and other acceptable methods. Other embodiments may also include devices having programmable and variable adjustable buoyancy by using ballast materials, specific expansion / contraction solutions, alternative structural materials, or other means. [0037] Referring to FIG. 5, one embodiment of the attenuator 66 including a movable wall such as an inflatable vessel 68 is shown. This inflatable container 68 is shown to have a substantially circular profile, but other profiles can be utilized in accordance with the present invention. In an application of the present invention in which only one attenuator is embedded, the diameter of the inflatable vessel 68 can vary from about 2.54 cm to about 15.2 cm (about 1 inch to about 6 inches). The diameter of many embodiments of the inflatable vessel 68 will be in the range of about 2.54 cm to about 7.62 cm (about 1 inch to about 3 inches) if the total volume is within the range listed above. In general, the particular dimensions and configuration of the vessel 68 have been selected to produce an attenuator with the desired volume and desired dynamic compression range, as will be understood by those skilled in the art based on the disclosure herein. , Can vary from spherical to relatively flat. [0038] In certain embodiments, two or three or more separate inflatable containers 68 are utilized. The sum of the volumes of the plurality of containers is equal to the desired amount of restored displacement. [0039] The inflatable vessel 68 shown in FIG. 5 includes a flexible wall 70 that separates the compressible contents of the attenuator 66 from the external environment. The flexible wall 70 includes a first component 74 and a second component 76 that are joined together by a seam 78 or the like. In the illustrated embodiment, the first component 74 and the second component 76 are essentially identical so that the seam 78 is formed on the outer circumference of the inflatable container 68. The seam 78 is one of a variety of techniques known in the field of medical device bonding technology, such as thermal bonding, adhesive bonding, solvent bonding, RF or laser welding, or other known in the art. It can be realized. [0040] The flexible wall 70 formed by the combined first and second component 76 defines the internal cavity 72. As discussed elsewhere herein, the internal cavity 72 preferably comprises a compressible medium such as a gas or foam. Alternatively, a medium or structure whose volume can be reduced by a mechanism other than strict compression can also be used. For example, materials that can phase change from a higher volume first phase to a lower volume second phase can also be used in the temperature and pressure ranges that occur within the bladder. [0041] In order to minimize trauma when delivering the attenuator 66, the attenuator is preferably inflatable from a first configuration with a small cross-sectional area to a second configuration with a larger cross-sectional area. Therefore, the attenuator 66 can be deployed transurethrally into the bladder in its first configuration and, once positioned in the bladder, can be expanded to its second configuration to achieve a pressure damping function. Preferably, the transverse profile or maximum cross-sectional configuration of the attenuator 66 in the first configuration is about 24 French (8 mm) or less, preferably about 18 French (6 mm) or less. This can be achieved, for example, by rotating the contracted inflatable container 68 around the vertical axis while exhausting the internal cavity 72. [0042] Once positioned within the bladder, the internal cavity 72 is filled with a compressible medium to produce the functional attenuator 66. The inventors of the present invention generally intend to charge a pressure of less than about 1.5 atm, and in some embodiments, intend to charge less than 1 atm in the case of the air-filled foldable attenuator 66. In general, the filling pressure is preferably less than or equal to the pressure required to keep the fully inflated attenuator 66 in the absence of pressure spikes. Excessive pressure in the attenuator 66 can reduce the dynamic range of the attenuator 66, which makes it less sensitive to damping pressure spikes. Pressures below 1 atm, or even vacuum, can be utilized if the structure of the attenuator is sufficient to balance the negative pressures to generate a net force to allow damping. This can be achieved, for example, in embodiments where a self-expanding support structure (eg, a nitinol wire frame) that biases outward in the radial direction is provided on the attenuator 66. [0043] Also, the elasticity of the attenuator material and the pressure of the expansion medium match so that the device produces a compression cycle time fast enough to respond to an increase in pressure that does not have a clinically detrimental effect on urination. It is preferable to do so. For example, the attenuator compression cycle preferably bottoms out or reaches a maximum in a sufficiently short time as the increase in detrusor muscle pressure, which has a clinical adverse effect on micturition, is minimized or impeded. [0044] After placing the attenuator 66 in the bladder, it is preferred that the inflatable vessel 68 be provided with a valve 80 to facilitate filling of the internal cavity 72. In the illustrated embodiment, the valve 80 is positioned to intersect the seam 78 and can be held in place by the same coupling technique used to form the seam 78. The valve 80 can be omitted in embodiments where the attenuator 66 is self-expanding. [0045] The valve 80 generally includes an aperture 82 for receiving a filling tube that passes through the interior. The aperture 82 is in fluid communication with the internal cavity 72 by a flow path 83. At least one closure member 84 is provided so that it flows through the flow path 83 in only one direction. In this way, the unfolding and filling device can be used to stagger the closure member 84 and introduce the compressible medium into the internal cavity 72. When the filling device is removed, the closure member 84 prevents or prevents the compressible medium from escaping from the internal cavity 72 through the flow path 83. [0046] Therefore, the closure member 84 can be moved between the first direction that obstructs the outflow liquid flowing in the flow path 83 and the second position that allows the inflow liquid to flow in the flow path 83. It is preferable to have. The closure member 84 is preferably offset in the first direction. Therefore, the forward flow is to the compressible medium in the flow path 83 by mechanically moving the closure member 84 to a second position, such as by using a filling tube, or to overcome the closure offset. This can be achieved by moving the closure member 84 to a second position by applying sufficient pressure. A particular valve structure is described below in relation to FIGS. 8A-E. However, any of a wide variety of valve designs can be utilized in the attenuator 66 of the present invention, as will be appreciated by those skilled in the art in view of the disclosure herein. [0047] In one embodiment of the invention, the device is a 0.0046 cm (0.0018 inch) thick polyurethane bonded to each other to form a 1.9 cm (2 · (3/8) inch) circle on the plan view. It consists of an air chamber consisting of sheets. In one embodiment, the device is made of polyurethane and is intended to expand to a pressure of about 1 atmosphere, or generally within the range of 0.5 to 1.5 atmospheres. Integrated with the sealing edge 78, the port / valve 80 used for equipment placement, expansion, and release is retained. Inside the port / valve structure 80 is the distal end of the rigid filled tube (0.050OD) 50. The valve 80 used may be one of the valves described in US Pat. No. 5,144,708, which is incorporated herein by reference. In an alternative embodiment, the device can be sealed in place after expansion, in which case the valve can be omitted. [0048] Biocompatible lubricants can be used to facilitate the placement of the device / filling tube within the lumen of the introducer. The distal tip of the introducer was modified to minimize trauma to the urethral tissue. Biocompatible lubricants can be used to easily insert the device into the urethra. [0049] With reference to FIG. 6, one attenuator deployer according to the invention is shown. Generally, the deployer 40 advances the attenuator 66 (not shown) transurethrally in the bladder in the first configuration with a small cross-sectional area, and then inflates or expands, i.e. expands the attenuator. It is designed to be oriented in the second embedding direction. Therefore, the particular configuration and functionality of the deployer 40 will be largely dominated by the particular design of the attenuator 66. Therefore, as will be appreciated by those skilled in the art in light of the disclosure herein, it is believed that various modifications and adaptations will be desirable for the particular deployer disclosed herein, depending on the corresponding attenuator configuration. Be done. [0050] The deployer 40 includes an elongated tubular body 42 having a proximal end 44 and a distal end 46. The tubular body 42 is sized for transurethral access to the bladder. Therefore, the tubular main body 42 preferably has an outer diameter of about 8 mm or less, preferably about 6 mm or less. The length of the tubular body 42 can vary depending on the desired proximal extension of the deployer 42 from the deploying urethra. In general, the axial length of the tubular body 42 ranges from about 5.1 cm to about 25 cm (about 2 "to about 10") for adult female patients and about 10 cm to about 51 cm (about 4) for adult male patients. Those in the range of "to about 20") are currently considered. [0051] The tubular body 42 is provided with at least one central lumen 48 extending axially within it. The central lumen 48 receives the filling tube 50 so that it can slide axially to fill the attenuator 66. The filling tube 50 includes a tubular body 52 having a proximal end 54 and a distal end 58. The inflatable lumen 60 extends over the entire length of the tubular body 52 and fluidly communicates with the proximal hub 56. Hub 56 includes connectors such as standard lure connectors for coupling to an expansion medium source. [0052] The axial length of the tubular body 52 is sufficiently longer than the axial length of the tubular body 42, the proximal hub 56 remains accessible to the clinician, and the attenuator 66 is deployed there. The function of filling in is realized. In one embodiment, an external tubular sheath (not shown) is slidably supported on the surface of the tubular body 42, which sheaths are radially spaced from the tubular body 52 and rolled inside. An annular cavity is defined to receive the mold attenuator 66. Thus, the contracted attenuator is wrapped around the distal portion of the annular body 52 and transferred within the tubular sheath during transurethral placement. Once the deployer 40 is properly positioned, the attenuator 66 in the contracted state is exposed by retracting the outer sheath proximal to the tubular body 52. The expansion medium source is coupled to the proximal hub 56 and the medium is introduced distally through the central lumen 60 to inflate the attenuator 66. After inflating the attenuator 66, the deploying device 40 is removed from the attenuator 66 by pulling the filling tube 50 into the tubular body 42 or the like. The distal stop surface 47 of the tubular body 42 impedes the proximal movement of the attenuator 66 when the filling tube 50 is retracted proximally. The deployer 40 is then removed from the patient, leaving an inflated attenuator 66 in the bladder. [0053] With reference to FIG. 6a, an example of modification of the deploying device 40 is shown. In this embodiment, the controller 62 is connected to the tubular body 52 via a proximal extension 60. The controller 62 may be in any of a variety of shapes, such as knobs and pistol-shaped grips. The clinician can grasp the controller 62 and utilize the filling tube 50 to advance or retract axially within the tubular body 42. A proximal hub 56 is connected to the tubular body 52 via a branch 61. As will be appreciated by those skilled in the art, the central lumen 60 extends within the bifurcation 61 to reach the proximal hub 56. Proximal extension 60 may include a closed tubular element or a solid element. An expansion source 64, such as a syringe, filled with a predetermined volume of air or other medium can be connected to the proximal hub 56. [0054] To ease the patient, the introducer should be properly sized to allow easy passage through the urethra (approximately 0.5-4 mm in diameter). Visual feedback is provided to the clinician via an insertion depth indicator along the longitudinal length of the introducer. The introducer may have an adjustable depth stopper that allows the clinician to preset the desired insertion depth. When the device is inserted into the urethra to the desired depth, the introducer is held in place and then the device attached to the distal end of the filling tube extends into the bladder lumen. The device is then filled with the indicated volume of gas from the attached syringe or similar device. Once properly inflated, the device is released from the filling tube using the tip of the introducer as a resistance to disengage the valve of the device from the filling tube. The filling tube is then fully retracted into the lumen of the introducer and then the entire assembly is withdrawn from the patient. The device is left in place for the clinically indicated period. [0055] With reference to FIGS. 7A-C, a disengagement sequence for deploying the inflatable attenuator 66 from the deployer 40 according to one aspect of the invention is shown. As shown in FIG. 7a, the deployer 40 is initially configured with a filling tube 50 positioned within the valve 80. The distal end 46 of the outer tubular body 42 is sized so that it does not fit into the aperture 82 of the valve 80. After positioning the attenuator 66 in the bladder, the filling tube 50 inflates the attenuator 66. [0056] Referring to FIG. 7B, after expansion, the filling tube 50 is pulled proximally so that it disengages from the valve 80. This is achieved by blocking the proximal movement of the attenuator 66 by the stop surface 47 at the distal end 46 of the tubular body 42. After that, the engagement between the attenuator 66 and the deploying device 40 is completely disengaged, and the deploying device 40 can be removed. [0057] With reference to FIG. 8A, a duck building embodiment of valve 80 is shown. The valve 80 includes a tubular wall 81 having an aperture 82 communicating with the flow path 83. At least one closure member 84 is attached to the tubular wall and extends across the flow path 83. In the illustrated embodiment, closure members 84 include first and second duckbill valve tips 86 and 88, which are attached to the tubular wall at lateral edges 90 and 92. Valve tips 86 and 88 slope distally toward the center into a pair of junction edges 94 and 96. In this configuration, the forward flow through the flow path 83 separates the junction edges 94 and 96, which allows the attenuator 66 to expand. When the expansion medium source is removed, the expansion medium in the attenuator 66 joins the valve leaflets in combination with the natural offset of the valve leaflets 86 and 88, which causes the expansion medium to flow out into the flow path 83. Can be prevented. [0058] [0058] The tubular body 81 and the first and second leaflets 86 and 88 can be made from any of a variety of materials understood by those skilled in the art. For example, the tubular body 81 can be made of polyurethane by extrusion molding or the like. The valve leaflets 86 and 88 can be made from any of a variety of flexible materials such as polyurethane, silicone, polyethylene, etc., using adhesives, thermal bonding, or other bonding techniques known in the art. Can be attached to the tubular element 81. Suitable valves include those made by Target Therapeutics and are marketed as DSB silicone balloons for embolization of aneurysms and arterial-venous malformations. [0059] With reference to FIG. 8B, the closure is realized by two joining edges on the distal end 106 of the tubular body 81. This structure is sometimes called a flapper valve. The tubular body 81 of this embodiment is formed by a first wall 96 and a second wall 100, which are joined or bent along the first edge 102 and the second edge 104 to extend inside. The flow path 83 is defined. The free distal ends of the first and second walls 96 and 100 at the distal end 106 form joint apex, which can be opened under the pressure of forward flow and therefore within the flow path 83. Backflow is blocked or prevented. [0060] With reference to FIG. 8C, the proximal end of the flow path 83 in the flapper valve or other valve structure of FIG. 8B can be reinforced by a reinforcing tube 108 or the like. Reinforcing tube 108 can be manufactured by any of a variety of methods. For example, the stiffening tube 108 can be extruded from various densities of polyethylene, PEBAX, polyurethane, or other materials known in the art. Reinforcing tube 108 is considered desirable to maintain the openness of the valve 80 passage, especially in embodiments adapted for coupling to the contraction and removal devices discussed below. Alternatively, the stiffening tube 108 is removable and can be used to prevent the valve from being sealed during the manufacturing process, and the filling tube can be easily placed within the valve. The reinforcing tube 108 can be removed after the end of the manufacturing process, or can be removed before, during, or after placement of the filling tube. [0061] Reference to FIG. 8D shows additional features that can be additionally incorporated into any of the valves discussed above. In this embodiment, an annular sealing ring 108 is provided on the inner surface of the tubular body 81. The annular sealing ring 108 is adapted to be sealed by the filling tube 50 so that the filling performance of the device is optimized. For this reason, the sealing ring 108 is preferably formed of an elastic material such as silicone or polyurethane and sized within it so that the filling tube 50 is slidably received. Alternatively, sealing with a filling tube can be improved by limiting the aperture diameter without using a separate sealing ring 108. [0062] With reference to Figure 8E, the valve can also be placed within the body of the attenuator rather than at the seam. Valves can be arranged in a number of ways, including those described in US Pat. No. 5,248,275 and US Pat. No. 5,830,780. [0063] It is also preferred that the implantable attenuator 66 be removable from the bladder. The removal can be done by any of various methods depending on the structure of the attenuator. Removal is preferably performed transurethralally. [0064] In most embodiments, removal is performed by reducing the attenuator 66 from its second expansion profile to its first reduction profile so that it can be pulled transurethrally by a recovery device. Become. Recovery catheters are configured in different states depending on whether the reduction from the second profile to the first profile is done by contraction or compression. An embodiment of a recovery device used to remove the inflatable attenuator 66 will be described below in connection with FIG. [0065] An alternative removal procedure involves melting or decomposing the material of the attenuator 66 or a portion of the material in situ. The material selection and wall thickness of the attenuator 66 can be optimized to achieve the desired life of the attenuator 66, which can then be dissolved in the aqueous environment of the bladder. Alternatively, accelerated events such as changes in pH, introduction of initiators or accelerators into the bladder, and reduced pressure can catalyze or accelerate dissolution or contraction. [0066] It is advantageous that the attenuator, which has a predetermined residence time, that is, is automatically emptied after that, does not require a removal procedure. Such temporary attenuators can be manufactured by various methods according to the invention, such as using bioabsorbable materials. In one embodiment, the entire wall of the inflatable container 68 is made of an absorbent material. As used herein, "absorptive" means any that dissolves, decomposes, is absorbed, or otherwise dissipates, regardless of chemical mechanism, in order to achieve the purposes listed herein. Means material. Alternatively, only part of the flexible wall 70, or other parts of the device, such as valves, are made from absorbent material. As soon as one or more windows or "fuse" components of the device are absorbed, the device can contract through the resulting opening and be pushed out during normal urination. In another alternative, one or more seams, such as seam 78, can be joined by a soluble or absorbent material designed to disappear after a given time in the aqueous environment of the bladder. Components that have contracted as a result of any of the time-limited embodiments described above can then be pushed out during normal drainage or in the bladder in a contracted state until removed using a removal device. Can be left in. [0067] The predetermined residence time in the bladder can be influenced by various design factors including the formulation of the absorbent material and the physical shape, thickness and surface area of the absorbent components. Various absorbent polymers that can be used in the present invention are known in the field of absorbent sutures. For example, DEXON sutures (Glycolide homopolymer, commercially available from Davis & Geck, Danbury, Connecticut), VICRYL sutures (copolymerized with glycolide and lactide, commercially available from Ethicon, Inc., Sommerville, NJ). ), POLYSORB sutures (also made of copolymers of glycolide and lactide, commercially available from United States Surgical Corporation in Norwalk, Connecticut) are specific materials known in the industry. An example, characterized as a short-term absorbable suture. Classified as short-term resorbable sutures generally refer to surgical sutures, which retain at least about 20 percent of their original strength 3 weeks after implantation and a mass of suture 60 after implantation. It is basically absorbed by the body within ~ 90 days. [0068] Certain bioabsorbable elastomers can also be used to form the devices or fuses according to the invention. Elastomers can be melted and sheets, plugs and tubular structures can be prepared, for example by extrusion molding. Alternatively, the copolymer can be injection molded to produce parts with complex designs, or compression molded to prepare the film. For more information on such melting techniques, see, for example, F. Rodriquez's "Principles of Polymer System" McGraw Hill, 1970, Chapter 12. [0069] A thin film can also be prepared by casting a solution of the bioabsorbable elastomer. Solution casting involves first dissolving the copolymer in a suitable solvent to make a solution, then casting the solution onto a glass plate to form a film, and then evaporating the solvent from the cast film. It can be achieved using the method. In another processing scheme, the copolymer can be lyophilized to prepare the foam. Freeze-drying can be achieved by first dissolving the copolymer in a suitable solvent, freezing the solvent, and then removing the solvent in vacuo. Suitable solvent sets include p-dioxane. The lyophilization technique for preparing the film is described in Aspects Theoriques Et Industriels De La Lyophilization by Louis Rey, 1964. [0070] Certain bioabsorbable elastomers are described in Bezwada et al., US Pat. No. 6,113,624, entitled Absorbable Elastomeric Polymer, the entire disclosure of which is incorporated herein by reference. According to the process described therein, a two-step, one reaction vessel, two temperature process is utilized and the mixture of p-dioxanone monomer and p-dioxanone homopolymer is from about 100 ° C to about 130 ° C. It is formed at a low temperature of ° C, preferably 110 ° C. The mixture is then reacted with lactide at a temperature of about 120 ° C to about 190 ° C to form a copolymer whose segment or sequence consists of repeating units of p-dioxanone and lactide. These segmented copolymers are less crystalline than previously known block or graft copolymers in the art and therefore have better strength but shorter BSR (break strength retention) profiles than block copolymers. , A material having a high absorption rate, a large elongation, and a low rigidity can be obtained. A wide variety of copolymers of polylactic acid and polyglycolic acid are also known in the art, especially those used with absorbent orthopedic screws and fasteners. [0071] The ideal material can be optimized by routine experimentation, taking into account the attenuator design and the desired indwelling time. The attenuator can be time-limited, such as 15 days, 30 days, 45 days, 90 days, 180 days, or any other number of days that may be required. The contracted or partially dissolved attenuator is transurethrally pushed out within 2-3 days of the expiration of the rated time from implantation. [0072] With reference to FIG. 12, a schematic side view of an embodiment of the intravesical removal device according to the present invention is shown. This device is adapted to recover the inflatable balloon attenuator discussed elsewhere herein. The removal device 150 includes an elongated tubular body 152 extending between the proximal end 154 and the distal end 156. The tubular body 152 is sized for transurethral access to the bladder. In one embodiment, the removal device 150 is adapted for use with a standard urological cystoscope (eg 21-24 French) with a minimum working channel of about 3.0 mm. Therefore, the total length of the removal device 150 in one embodiment is about 76 cm, and the usable length is about 60 cm. [0073] The tubular body 152 can be manufactured according to any of a variety of techniques well understood in the field of catheter or other medical device manufacturing techniques. In one embodiment, the tubular body 152 is extruded from a biocompatible material such as TFE and has an inner diameter of about 0.23 cm (about 0.09 inch) and a wall thickness of about 0.025 cm (about 0.01 inch). [0074] The proximal end 154 of the tubular body 152 is connected to the Y-adapter 158. The Y-adapter 158 supports a controller 160 for controlling the recovery device as described. The controller 160 of the illustrated embodiment includes a thumb receiver 162 that is slidably supported against a pair of finger rings 164. The axial movement of the thumb receiver 162 with respect to the finger ring 164 expands or retracts the recovery loop 166 extending distally from the distal end 156 of the tubular body 152. The recovery loop 166 is fitted to surround the inflatable attenuator 66. In one embodiment, the loop 166 has an expanded diameter of about 27 mm and includes a wire such as a stainless steel cable wire with a diameter of 0.041 cm (0.016 inch). [0075] In use, loop 166 opens when the distal end 156 of the tubular body 152 reaches the bladder. Position the loop 166 around the attenuator 66 and operate the proximal controller 160 to tighten the loop 166 around the attenuator 66. After firmly gripping the attenuator 66 with the loop 166, a contraction tube 168, preferably having a pointed distal tip 169, is advanced distally through the wall of the attenuator 66. Distal advancement of the contraction tube 168 can be achieved by advancing the proximal controller, such as controller 172, distally. The distal tip 169 fluidizes a connector such as a standard lure adapter 170 through a central lumen (not shown), thus connecting an empty syringe or other device to the connector 170 and looping. The contents of the attenuator 66 can be discharged. Since the attenuator 66 contracts, the controller 160 can be operated to pull the collapsed attenuator 66 into the distal end 156 of the tubular body 152. The removal device 150, which has or supports a reduced attenuator 66 internally, can be removed transurethrally from the patient. [0076] The removal device 150 described above can be extensively modified within the spirit of the present invention. For example, the proximal controllers 160 and 172 can be combined with a pistol-shaped grip or other configuration. The controller 172 or 160 can further control the warpage of the distal end 156 of the tubular body 152 or the rotation of the loop 166 plane. In general, the removal device 150 preferably allows the positioning of the attenuator 66, captures the attenuator, reduces the size of the attenuator, and provides the basic function of removing the attenuator from the bladder. The step of capturing the attenuator is by making the attenuator visible with a urological cystoscope, or by a "blind" technique such as the magnetic locator described below in connection with Figures 21, 22 and 23. , Can be realized. [0077] Referring to FIG. 13, a plan view of an alternative attenuator 180 according to the invention is shown. The attenuator 180 generally includes an inflatable body 68 as already mentioned. A valve 80 can be provided at the external seam 78. In this embodiment, the internal seam 182 defines the central region 184. The outer seam 78 and the inner seam 182 define a substantially toroid-shaped inflatable vessel 68. The central region 184 can include a membrane or a central opening depending on the desired performance characteristics. The central hole assists in positioning and positioning the device within the bladder, allowing further diversion of pressure waves within the bladder and minimizing attachment to the bladder wall due to surface tension between the device and the bladder. Urine can flow through the hole if the device is in or near the bladder neck. [0078] In one embodiment shown in FIG. 14, central region 184 includes baffle 186. The baffle 186 includes a film 188 having a plurality of apertures 190 inside. In the illustrated embodiment, about nine round apertures 190 are provided, each having a diameter of about 0.5 cm (about 0.2 inches). Generally, at least about 9 apertures 190 are provided, and many embodiments include a number of apertures between about 1 and about 1000. The optimum number of aperture 190s and the sum of the area of aperture 190 relative to the total area of baffle 186 can be optimized according to the desired performance characteristics. The aperture may be any of round holes, irregular openings, slits, or various other configurations. [0079] The wave diffuser function of the baffle 186 is schematically shown in FIG. Wave surface 192 can be caused by any of a wide variety of events, such as coughing, sneezing, laughing, body movements, muscle cramps, or other events that are understood. Since urine contains incompressible water in nature and the dynamic compliance of the bladder is low, the wave surface 192 propagates rapidly through the bladder, impacting structures such as the triangular region and the urethra. 80cmH during normal activity₂Apparent transient pressure spikes of O or higher can occur. Due to the shape of the bladder, these pressure waves can actually be concentrated in the triangle and bladder neck. In addition to reducing the pressure caused by pressure events such as coughing, the devices discussed above can also provide a baffle that disperses waves throughout the bladder, dispersing and reducing focused wave surfaces in contact with the bladder neck. [0080] [0080] When the attenuator 180 with the baffle 186 is positioned within the bladder, the bladder 186 functions to prevent the centralized progression of the wave surface 192. Therefore, the wave surface 192 before diffusion is blocked by the baffle 186 and becomes a plurality of wave surfaces 194 after diffusion. Although the sum of the resulting post-diffusion wave surfaces 914 is essentially equal to the pre-diffusion wave surface 192, we have seen the wave surface 192 received by the target tissue in the bladder due to the greater distribution of force by the baffle 186. I think that the size of [0081] As will be made clear in light of the above, the baffle 186 can be constructed by any of a variety of methods and the intended result is still achieved. Thus, although the attenuator 180 shown in FIGS. 13 and 14 includes a substantially toroid inflatable vessel, any of a variety of other support structures can be utilized to keep the baffle 186 in a usable configuration. Alternatively, the support 196 can include an elastic tube, an elastic material such as a nitinol wire, or any other support structure desired. [0082] With reference to FIG. 16, various alternative shapes of the type of attenuator 66 that use an inflatable vessel are shown. The device used in the embodiments of the present invention can take many forms. In some cases, for manufacturing purposes, it may be desirable to have a shape similar to a dip-molded instrument such as a condom, a finger of a surgical glove, or a children's toy. However, many other forms can provide better performance, especially to divert the pressure wave with the damping of the pressure spike. Possible device shapes include toroid-like shapes that are similar in shape but not in size to donuts and inner tubes, spoke-wheel shapes, horseshoe-like shapes, mushroom-like shapes, and banana-like shapes. included. [0083] In other embodiments of the invention, the device can be dip-molded or extruded in multiple biocompatible materials. In addition, the device can be made from various multilayer complexes or can be made by several different manufacturing processes. The device can also be formed from thin film sheet stock (mylar, polyethylene, polypropylene, polyurethane). It is important to note that the material need not be at all elastomeric in order for the present invention to function. However, the materials selected for use in embodiments of the present invention should be sufficiently flexible in thickness as required by the design selected. When external pressure is applied to the device, the material of the device can transmit that pressure to the contained air or pressure control structure and respond sacrificially as one of the most compliant members of the urinary system. be able to. [0084] FIG. 16A shows a toroid-shaped embodiment with multiple central spokes. Figure 16B shows a crescent or "C" shaped attenuator. Any of a variety of spherical, oval, oval, or other shapes as shown in Figure 16C is available, in which case the maximum length dimension of the inflatable attenuator is approximately 1 of the minimum cross section. ~ It is within the range of about 5 times. FIG. 16D shows an inadequate bow-shaped type as shown in FIG. 16B. Generally, the attenuator 66 provides one of various forms that provides sufficient volume to achieve the desired damping function and minimizes or eliminates the risk of loss or obstruction of outflow through the urethra. Can be taken. [0085] Referring to FIGS. 17A and 17B, an axially compressible mechanical bellows attenuator according to the present invention is shown. The device of the embodiment of the present invention for absorbing transient pressure changes includes a diaphragmatic structure, a rigid structure, that is, a structure in which both shapes are changed and become rigid by coating, and a bellows or bellows-like device. These are capable of attenuating pressure waves within an organ, cell, or cavity of the body as part of a stand-alone device or wall or structure of a subject organ. An embodiment of a mechanically assisted device is shown in FIG. Figure 17A is a mechanical bellows in a normally extended position. The pressure in this bellows is reduced so that the device keeps its extended position normally but is compressed by the external pressure applied to the device. Bellows can be made from plastic or metal (such as Senior Flextronics, Inc., Sharon, MA titanium or stainless steel). The bellows can be sealed or covered with a material that reduces the air pressure in the device. [0086] This technique is advantageous for changing the volume considerably with changes in pressure. Although the theoretical limits of the air chambers described herein can only be reduced by about 25% of their volume, this bellows device can shrink to nearly 90% of its volume. [0087] The bellows attenuator 200 includes an accordion-foldable membrane 202. The membrane 202 may be self-supporting or may be provided with an inner frame or an outer frame. The frame has a structure such as a simple spring arranged parallel to the vertical axis of the bellows, and a structure such as a wire pantograph that can be compressed in the axial direction and can be swiveled as understood in the art. , Can include any of various structures. [0088] Referring to FIG. 18, an alternative mechanically assisted accumulator 210 according to the present invention is shown. In this embodiment, the compressible tubular wall 212 with closed ends 214, 216 is supported by a self-expanding tubular frame 218. Either a variety of self-expanding tubular or spherical frame structures can be utilized, such as the "zigzag" wire frame well known in the art of abdominal aortic aneurysm grafts. Applications of abdominal aortic aneurysm grafts generally require a relatively high radial outward force, but in the present application, it is preferred to be able to compress with a relatively low compressive force (ie, a low radial force). Be done. This is a smaller gauge wire with fewer wires per graft and is used by using adjacent tips without connecting them to each other, or by reducing the radial force of the wire cage. Can be achieved by using. The wire cage or other support structure is preferably surrounded by a permeable membrane such as a balloon. The pressure in such a balloon may be less than 1 atmosphere. [0089] Referring to FIG. 19, an alternative layout for the inflatable attenuator 66 of the present invention is shown. In this embodiment, the plurality of attenuators are connected by a common flow path, so that the plurality of attenuators can be inflated through a single inlet. Alternatively, multiple self-inflating attenuators are connected by sutures, nitinol wires, or other connecting wires. In this embodiment, the transverse profile can be minimized, or a constant transverse profile can be maintained no matter what value the total product takes as desired when the attenuator expands. it can. [0090] Figures 20-23 show a magnetic positioning system that allows "blind" recovery without the use of a cystoscope. To remove the attenuator from the bladder, a recovery assembly is inserted into the urethra to perform intravesical capture, contraction, and extraction of the attenuator. The recovery assembly utilizes a magnet whose polarity and magnetic path are oriented to ensure a predictable attraction and coupling between the attenuator containing the magnet and the recovery assembly. Coupling the recovery assembly to the attenuator and puncturing and contracting the attenuator using a clip of biopsy forceps (or any other solution suitable for disassembling the device) located at the distal end of the recovery assembly. Can be done. Alternatively, the residual gas can be passively evacuated into the bladder or through the collector body. Once contracted, the attenuator can be pulled out through the urethra attached to the recovery assembly or removed from the bladder as part of the urinary flow. [0091] Thus, with reference to FIG. 20, an attenuator 230, such as an inflatable balloon, is shown, as previously mentioned herein. The attenuator 230 is provided with a valve 232 and a positioning element 234. The positioning element 234 may preferably be of any of a variety of structures capable of positioning the attenuator 230 without the need for direct visibility. [0092] In the illustrated embodiment, the positioning element 234 may be one or more magnets 236. In the embodiment shown in FIG. 21, the magnet 236 constitutes an annular ring surrounding the flow path 83. The distal end of the catheter 240 is provided with a corresponding magnet 238 having a polarity opposite to that of the magnet 236. When the catheter 240 is positioned near the attenuator 230, the attractive forces of the magnets 236 and 238 of opposite polarities cause the catheter 240 to couple to the attenuator 230 as shown in FIG. [0093] Referring to FIG. 20, by connecting the positioning element 234 to the catheter 240, the attenuator 230 is placed in fluid contact with the catheter 240 by at least one lumen 242. The lumen 242 can be used to introduce the expansion medium or remove the expansion medium from the attenuator 230. In FIG. 22, valve 232 is a ball valve, which is urged in a closed orientation. However, the mechanisms and structures disclosed herein can be used with any of the other valves disclosed elsewhere herein. As shown in FIG. 22, the valve actuator 234 can be moved distally within the lumen 242 to displace the valve 232 and inject or remove the expansion medium. After injecting or removing the desired volume of expansion medium, the valve actuator 234 can be retracted proximally to close the valve under its own bias. See Figure 23. [0094] Opposite magnets 236 and 238 can simply be used as positioning structures so that the catheter 240 can be locked to the attenuator 230 using an additional locking element (not shown). This is considered desirable if the strength of the bond formed between the two magnets during the filling or removal step is insufficient to keep the attenuator 230 bound to the catheter 240. Further, as will be apparent to those skilled in the art in light of the disclosure herein, the catheter 240 and the attenuator 230 are generally relatively tightly coupled in order to recover the attenuator 230 after contracting the attenuator 230. Need to be done. [0095] According to another embodiment of the invention, the recovery catheter is provided with one or more ultrasonic transducers at its distal end. An air-filled attenuator should strongly reflect the ultrasonic signal in a manner similar to the reflection achieved at the air-water interface. A recovery catheter with a deflectable distal tip and capable of emitting ultrasound should be able to travel within the bladder so that the attenuator is positioned without the need to make it visible. The recovery catheter may additionally be provided with two or more opposed mechanical gripping elements such as gripping elements and / or vacuum lumens for attachment to the surface of the attenuator by suction. Once attached, the attenuator can be punctured and pulled out transurethrally. [0096] In another embodiment of the invention, the device can take a number of shapes in the process of its use. For example, the device can be fully contracted for introduction and can be expanded to varying degrees after introduction. The device can be adjusted by expansion / contraction of a second or multiple confined cells for purposes such as stabilizing or adding diagnostic, therapeutic, or signaling substances. This can be done with multiple single lumens or single multi-lumens, a multi-port structure, or a combination thereof. [0097] In another embodiment of the invention, the filling tube / introducer assembly and the recovery assembly are two separate instruments. [0098] In another embodiment of the invention, the filling tube / introducer assembly and recovery assembly can be performed using a single instrument. Alternatively, one instrument with separate distal ends can be used for the fill tube / introducer assembly and the recovery assembly. [0099] In another embodiment of the invention, an endoscope can be used to deliver and retrieve the device. [0100] In another embodiment of the invention, the distal end of the filling tube / introducer can be straightened, pre-bent and malleable to facilitate delivery and / or release of the device. Can be or can be made mobile (eg by pull wire). [0101] In another embodiment of the invention, separation of the device from the filling tube can be achieved using the wall of the urethra, or the neck of the bladder, as a mechanically durable material. [0102] In another embodiment of the invention, the filling tube and introducer are a single tubular element, a series of concentric tubular elements, a series of non-concentric tubular elements, an extruded element, a spirally twisted guide wire element, or , Can consist of any combination of the aforementioned elements arranged to exert the desired function. [0103] Other embodiments of the invention use coatings to physically or chemically combine all or part of the device with a coating to alter properties such as lubricity and the ability to prevent the deposition of substances present in the urinary tract. It addresses the problem of irritation by changing to. For example, substances such as sulfated polysaccharides can be used before, during, or after introduction into the patient. Furthermore, for the purposes described above, a plurality of constituent materials having unique surface properties can also be used. [0104] In another embodiment of the invention, the device spans a distance from the inner surface to the outer surface that allows the positioning of erosive substances that are believed to allow the device to contract or decompose after being exposed to urinary tract conditions for a predetermined period of time. It can also include a portal. This technique can also be used to release a single or multiple therapeutic, diagnostic, or signal-generating substance from a single or multiple chambers within the device by programmed massive release. [0105] In another embodiment of the invention, the device comprises a valve / port that is programmable, self-regulating, or responsive to stimuli, which is considered physiological or non-physiological. Telemetry, physical connectivity, or remote signal transmission can also be used to elicit the desired response. [0106] In another embodiment of the invention, the device accepts, captures, and transforms physical forces within the urinary tract to energize sites within the device, either continuously or as a mass, outside the boundaries of the device. The substance can be reliably pushed to the surface. [0107] In another embodiment of the invention, the port / valve of the device need not be associated with the sealing edge of the device. [0108] Other embodiments of the invention include devices similar to other described embodiments, but include thin, flexible, and secure connecting lines that extend from the device and are long enough to exit the urethra. See Figure 24. The connecting line can be made of an acceptable material such as a suture or one used in the manufacture of a catheter, and may also have antibacterial properties. In one embodiment, a lightweight pendant of sufficient bulk is attached to the distal end of the connecting line to prevent the entire connecting line from entering the urethra. In normal use, the pendant can be temporarily attached to the patient's pelvic area. This connecting line can be used to remove or disassemble the device, and this connecting line gives the patient the ability to instantly remove the device when he or she wants to pull it out. It is a thing. [0109] Other embodiments of the present invention are similar to those described above, except that the device has a chambered structure consisting of a large number of subchambers that perform a number of functions. See Figures 25 and 25A-C. The first device may or may not be fluidly connected to the second device. The fluid connection also acts as a connecting line with sufficient service loops, allowing the second device to be placed in the urethra without anchoring the first device in the bladder. During the urine pressure spike, the gas in the first device is compressed in proportion to the external load. The compressed gas then moves to the second device, pauses in the urethra, and the second device expands proportionally. Due to the design of the second device, the swelling occurs radially outward and laterally to the longitudinal axis of the urethra, thus increasing the innate radial inward contraction of the urethra. This type of "on-demand" synchronous resistance augmentation can be even more effective than other forms of passive or patient-controlled augmentation devices. Another advantage of this embodiment of the invention is that synchronous outward radial forces can be utilized to stabilize the position of the device within the urethra. Passive devices must maintain a sufficient holding capacity (tissue displacement or force) at all times to withstand maximum drainage. This retention level can cause patient discomfort and can cause long-term tissue damage. [0110] In another embodiment of the invention, the first device may resemble a small three-spoke automobile steering wheel, or a rotating toroid-shaped space station. See Figure 16A. The outer ring is thought to contain the first device, and the inward radial spokes are thought to provide the fluid conduit and mechanical support for the second device attachment. The first device may also incorporate one or more hyperelastic wire members that retain their shape to help stabilize the position of the first device. The second device can resemble the distal tip section of a small diameter angioplasty device and can be attached to a central hub. [0111] In another embodiment of the invention, the expansion / contraction response of the second device can be designed in a controlled state, if necessary. For example, it may be advantageous to inflate the second device as quickly as possible, but to cause a response lag in the contraction / expansion cycle to protect against the next cough, sneeze, or jump. [0112] In another embodiment of the invention, a pressure compensator or bladder trainer can be implanted intraperitoneally, can be connected to the bladder by water or air pressure, or can be attached as a component of the bladder wall. The device consists of a rigid external enclosure to protect the compressible elements from abdominal forces. The function of this embodiment is not only to manage transvesical pressure in treating clinical complaints, but also to increase muscle tone, compliance, or affect the neuromuscular elements of the bladder. It is thought to introduce a pressure wave on the outside or inside of the bladder. [0113] The above embodiments have been described for use in the human bladder. As will be appreciated by those skilled in the art, the present invention is not limited to human use, and the inventions disclosed herein appropriately scaled in size also include domestic pets that are mammals. But it can bring clinical benefits to other animals. [0114] Embodiments of the present invention offer considerable advantages over prior art devices. These benefits include a significant reduction in events related to bladder dysfunction, the ability to hold the bladder with non-normal compliance, no patient interaction required to operate or maintain the device, and the patient in the usual way. The ability to urinate, the absence of an infectious conduit between the bladder and the distal end of the urethra, minimal sensation caused by the device, low manufacturing costs, and cost-effectiveness for patients compared to existing treatments It includes being a solution and being easy for clinicians to install and remove. [0115] The present invention also provides devices and methods for measuring dynamic bladder compliance. In one embodiment, the device can be used in combination with a filling tube / introducer to measure the dynamic compliance of the bladder. One lumen of the filling tube can be used to rapidly inflate the device and a second lumen can be used to measure bladder pressure. In one embodiment, the volume of the bladder is increased from at least about 30 cc or 50 cc up to 200 cc in about 0.5 to 10 seconds to measure the dynamic compliance of the bladder. [0116] The present invention provides methods and devices for restoring dynamic bladder compliance by re-educating bladder tissue by introducing pressure waves in place with predetermined properties. [0117] The invention also provides methods and devices for programmatically delivering clinical therapeutics in connection with defined pressure events. The present invention can be added to other intravesical devices such as Foley catheters and intravesical infusers, such as those described in WO99 / 24106, or to the ends of urethral stents, thereby delivering delivery. It can be promoted, treat multiple symptoms, or improve the performance of any device. [0118] For example, an attenuator can be activated in combination with an intravesical infuser to time drug release in response to intravesical pressure events. [0119] The present invention also provides a non-traumatic method of measuring intravesical pressure without the need for any external connection by placing a pressure transducer and a telemetry device within the accumulator. In this method, the transducer is fixed in the bladder and there is no need to attach the transducer to the bladder wall. [0120] Embodiments of the present invention are not limited to intravesical devices, but also include devices and methods for controlling transient phenomena of pressure within other organs of the body, as discussed below. [0121] One embodiment of the invention is to reduce the mean arterial pressure, systolic pressure, and / or diastolic pressure to apply the pulsatile force of a normal or highly physiological event to the heart and / or the heart. Alternatively, it is intended for use in cardiovascular applications because it modulates the pressure wave so that the vascular structure is not damaged. See Figure 29. Accumulators can be placed on the wall of the heart, in the major arteries, or in the left atrial appendage of the heart (see Figures 30A and 30B) to reduce the risk of renal failure, stroke, heart attack, and blindness. .. The accumulator can be placed on the right side of the heart, inside the right side, or in the pulmonary artery to alleviate the symptoms of primary persistent hypertension. Accumulators should also be placed on the venous side of the vasculature, such as within the walls of the vena cava, or attached to a greenfield filter within the vena cava to prevent portal hypertension and / or esophageal varices. You can also. An accumulator, such as an air chamber, can be attached to or include a stent for placement within the vascular structure. [0122] Another embodiment of the invention can be used on the gallbladder to modulate the pressure trapped therein. Pressure in the gallbladder can cause undesired events for the patient, such as stones and pain. The accumulator can also be placed at the end of the nasogastric tube in the esophagus to control spasms. The accumulator can be placed in the intestinal tract to treat irritable bowel syndrome and minimize any other disorders resulting from Crohn's disease, spasms, or peristalsis. See Figure 31. [0123] Another embodiment of the invention can also be used in the field of ophthalmology to support craniofacial tissue during healing after trauma, or to be used intraocularly as a treatment for acute angle-closure glaucoma. You can also. [0124] Another embodiment of the invention can also be used in the field of orthopedics as an implantable or external device to prevent pressure waves after trauma and control the site of healing bone. [0125] Another embodiment of the invention can also be used in the field of otolaryngology to manage pressure waves in the ears, nose, and in the sinus, including inside and around the throat. [0126] Accumulators can also be placed inside the lungs to treat disorders such as asthma, bronchiolespasm, or to prevent fragile lung tissue in patients with emphysema, for example, from being damaged by coughing. [0127] Accumulators can also prevent central nervous system (CNS) problems such as head trauma, cerebral edema, and hydrocephalus. The accumulator can be placed in the dural pocket below the skull. [0128] In the embodiment of the invention described above, an air chamber device is placed within the bladder and / or other organs of the body, the device being filled with a compressible material to provide pressure compensation or the device being compressible. Consists of matter. It also describes an active programmable pressure compensator or generator designed to monitor pressure events, respond in a predetermined manner, and record or transmit that information outside the body. In addition, a reliable, maintenance-free therapeutic drug delivery device that uses erosive or deformable support matrices or components and / or programmable or responsive valve systems to programmatically deliver drugs. Describes a device designed to be released or distributed within the body's organs. [0129] By describing certain embodiments of the present invention in this way, various modifications, modifications, and improvements will be apparent to those skilled in the art. Such modifications, modifications, and improvements shall be within the spirit and scope of the present invention. Therefore, the above-mentioned items are given as examples, and are not limited thereto. [Simple explanation of drawings] FIG. 1 is a diagram showing the maximum intraurethral pressure with respect to the intravesical pressure during normal urination. FIG. 2 shows the intravesical pressure exceeding the maximum intraurethral pressure in a non-compliant bladder. FIG. 3 shows intravesical pressure spikes above maximum urethral pressure during stress incontinence. FIG. 4A shows the relationship between cough-induced urinary urgency or pollakiuria-induced intravesical pressure and detrusor muscle pressure. FIG. 4B shows the relationship between intravesical pressure and detrusor muscle pressure during urinary urgency or pollakiuria that was not induced by cough. FIG. 5 is a schematic plan view of an inflatable attenuator according to an aspect of the present invention. 5A is a side sectional view of the attenuator of FIG. FIG. 6 is a side schematic view of an attenuator deploying device according to an aspect of the present invention. FIG. 6A is a schematic side view of an alternative embodiment of the present invention. 6B is a cross-sectional view taken along line 6B-6B of FIG. FIG. 7A is a partial schematic of a filling tube of a deployer engaged in a valve of an attenuator. FIG. 7B is a partial schematic similar to FIG. 7A, with the filling tube pulled proximally from the valve. FIG. 7C is a partial schematic similar to FIG. 7B with the deployer removed from the attenuator. 8A to 8 are diagrams schematically showing various valve structures related to the inflatable attenuator according to the present invention. FIG. 9 is a schematic view of the deployer of FIG. 6 positioned transurethralally within the bladder. FIG. 10 is a schematic view similar to FIG. 9 in a state where the attenuator is inflated. FIG. 11 is a schematic representation of an alternative embodiment of the deployer according to the invention, transurethrally positioned within the bladder. 11A is a cross-sectional view of an embodiment of the deploying device of FIG. FIG. 12 is a side schematic view of an attenuator removing device according to an aspect of the present invention. FIG. 13 is a schematic view of a toroid attenuator according to an embodiment of the present invention. FIG. 14 is a schematic view of a toroid attenuator similar to FIG. 13 having an integrated baffle inside. FIG. 15 is a schematic view of an attenuator that impedes unidirectional travel of a pressure wave front. 16A-D are schematic views of various inflatable attenuators according to the present invention. FIG. 17A is a schematic side view showing an expanded configuration of a bellows type mechanically assisted attenuator. FIG. 17B is a schematic side view of the attenuator of FIG. 17a, which has a compressed configuration to attenuate pressure spikes. FIG. 18 is a side schematic view of a self-expanding graft type mechanically assisted attenuator. FIG. 19A is a side schematic of a multi-chamber attenuator according to another aspect of the invention. FIG. 19B is a schematic view of the multi-chamber attenuator of FIG. 19A in an unfolded orientation to ensure retention within the bladder. FIG. 20 is a side schematic view of an inflatable balloon attenuator having a balloon valve that can be positioned at the top. 21 is a schematic perspective view of the attenuator of FIG. 20, positioned at the distal end of the deployed or recovery catheter. FIG. 22 is a partial cross-sectional view of the distal end of a deployable or recovery catheter and the proximal end of the valve on the attenuator, showing the valve in the fill or drain orientation. FIG. 23 is a partial cross-sectional view similar to FIG. 22 showing a valve in a sealed orientation. FIG. 24 is a schematic cross-sectional view of the bladder showing a state in which an attenuator with an attached external connecting line is inside. FIG. 25 shows a two-component attenuator in which the first compressible component is positioned within the bladder and the second inflatable component is positioned within the urethra. It is a schematic cross-sectional view of a bladder. FIG. 25A is a schematic cross-sectional view similar to FIG. 25 showing a state in which the first attenuator compresses in response to rising abdominal pressure and the second inflatable component expands accordingly. 25B is a schematic enlarged portion of the inflatable component of FIG. 25A. FIG. 25C is a pressure curve showing intravesical pressure compared to second balloon pressure. FIG. 26 is a diagram showing the effect of the presence of the implantable attenuator according to the present invention on the intravesical pressure. FIG. 27 is a schematic cross-sectional view of the bladder showing an attenuator fixed to the bladder wall. FIG. 28 is a schematic cross-sectional view showing the transurethral arrangement of the bladder and the dynamic compliance measurement catheter according to the present invention. FIG. 29 is a schematic cross-sectional view of a blood vessel showing a state in which a tubular attenuator is present. FIG. 30A is a schematic cross-sectional view showing a state in which an air chamber attenuator is positioned inside the left atrial appendage of the heart. FIG. 30B is a schematic cross-sectional view similar to FIG. 30A showing a bellows type attenuator positioned in the left atrial appendage. FIG. 31 is a schematic cross-sectional view of a tubular attenuator positioned within the colon.