Abstract:
An implantable urodynamic system includes an implantable first device deployable in a patient&#39;s bladder, an implantable second device deployable in a patient&#39;s vaginal canal, and a data acquisition and analysis module or processing unit external to the body of the patient. The first device includes a magnet and an inductive coil, and the second device includes a magnet, an inductive coil and a battery. When deployed in the patient&#39;s body, attraction between the magnets maintains the two devices in close proximity to one another to effect an inductive coupling between the coils so that the first device may be powered by the battery of the second device. The urodynamic system is intended to facilitate measurement, collection, and wireless transmission of real-time, or near real-time, data (bladder pressure, abdominal pressure, and temperature) from an ambulatory patient. This data is of value in diagnosing a number of abnormal bladder conditions, such as infection, overactive bladder, bladder spasms, and the like.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to devices and methods for urodynamic evaluation, and more particularly, to such a system and method that utilizes micro-electronic mechanical system (MEMS) technology. 
     2. Description of the Prior Art 
     In order to treat urinary incontinence, it must first be understood which type of incontinence the patient is suffering from, and the physical causes for the incontinence. Many types of urodynamic systems and tests are currently available to try to assess the type and causes of incontinence. These systems can be broadly categorized in two ways: office based systems and ambulatory systems. 
     Office based systems are designed for use in a doctor&#39;s or clinician&#39;s office. Many of these systems involve invasive testing using catheters and the like. Ambulatory systems are designed to capture data outside the office over a longer period of time, such as 1-2 days. 
     Known ambulatory systems for urodynamic measurements are also invasive in that they use catheters to capture pressure data within the urethral tract or in the bladder. It is readily apparent that such known ambulatory systems are uncomfortable and invasive for the patient. Further, because the catheters are inter-dwelling, they are prone to movement or migration over time as the patient moves around. In addition, they may not accurately capture typical daily occurrences, as the patient is, due to the discomfort, prone to move less and engage in fewer activities than normal while undergoing the assessment. Finally, the invasive catheters may also interfere with true physiological responses, as they can irritate the internal tissues/organs through which they are inserted. Thus, migration of the pressure sensors and their invasive nature limits the reliability and usefulness of the data. Another ambulatory system describes implanting a device within the bladder of the patient, but retrieval of the device can be an issue. 
     U.S. patent application Ser. No. 11/043,830, filed on Jan. 26, 2005, having Michael R. Tracey and Anthony DiUbaldi as the named inventors, and entitled “System and Method for Urodynamic Evaluation Utilizing Micro-Electronic Mechanical System”, and further being published on Aug. 11, 2005 and being assigned Publication No. US2005/0177067A1, the disclosure of which is incorporated herein by reference, describes an implantable urodynamic system for implanting within a patient&#39;s body. It includes two implantable devices. The first device, sized for implantation within a patient&#39;s bladder, includes a power source, at least one sensor for sensing a physiological property within the bladder, and a data storage element for storing data representing the physiological property sensed by the sensor. The first implantable device also includes a collapsible housing. The collapsible housing has a collapsed configuration sized for insertion through the patient&#39;s urethra and into the patient&#39;s bladder, and an expanded configuration sized for insertion within the bladder, but to prevent its passage from the bladder into the urethra. 
     The system can also have a second implantable device sized for implantation within the patient&#39;s vagina. This device also has a power source, at least one pressure sensor for sensing pressure within the vaginal canal, and a data storage element. In addition, it has a data retrieval device for retrieving and manipulating data from the first and second data storage elements once the devices are removed from the body. This second implantable device is encapsulated within a pliable casing, such as cotton, dimensioned to hold the device against the vaginal walls. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide an implantable urodynamic system formed of components which are deployable in a patient&#39;s bladder and vaginal canal and which are structured and cooperate to facilitate the retrieval of the components therefrom. 
     It is another object of the present invention to provide an implantable urodynamic system having components deployable in a patient&#39;s body which remain properly positioned therein without migration in the patient&#39;s body. 
     It is yet a further object of the present invention to provide an implantable urodynamic system which senses a physiological property or properties within a patient&#39;s body and minimizes or eliminates the possibility of erroneous measurements being made. 
     It is a further object of the present invention to provide a urodynamic evaluation system for measuring a physiological property of a patient while the patient remains ambulatory. 
     It is still a further object of the present invention to provide an implantable urodynamic system having components which may be implanted in a patient&#39;s body for relatively long periods of time. 
     It is yet another object of the present invention to provide a system and method for urodynamic evaluation which utilizes micro electro-mechanical system (MEMS) technology and which further overcomes inherent disadvantages associated with conventional office-based urodynamic systems and ambulatory systems. 
     In accordance with one form of the present invention, a urodynamic system, preferably constructed using MEMS technology, includes a first implantable device and a second implantable device. 
     The first implantable device, which is preferably sized to be placed in a patient&#39;s bladder, is inductively coupled and powered by the second implantable device via a magnet and coil situated on one end of the first implantable device. The first implantable device further has a sensor on an opposite end. The bladder implantable device is used to acquire patient bladder pressure data, or alternatively, temperature data, which are used for the diagnosis and treatment of bladder function, with the expressed purpose of allowing the patient to remain ambulatory. This device may include other functions and sensors, for example, to measure flow rate (e.g., urination), temperature or acceleration (e.g., movement and orientation of the patient). 
     The second implantable device of the present invention is sized for implantation within the patient&#39;s vagina. It includes a power source, such as a battery, a pressure sensor, a data storage element, and a data retrieval device, housed within an outer shell. A thin-walled inflatable sleeve or cuff with a seal ring is mounted over the anterior portion of the outer shell of the second implantable device. This inflatable sleeve or cuff is used to securely position the device in the vagina. When pressurized, the sleeve expands radially against the vaginal walls, helping to secure the second implantable device in the correct position. Also, anti-rotational ribbing and/or surface texturing on the inflatable sleeve further assists in maintaining the proper orientation of the second device within the patient&#39;s vagina. 
     Even more preferably, the sleeve has variable thickness walls which, along with the molded ribs, preferentially bias the sleeve to expand radially, with minimal elongation. A small hole in the anterior end of the outer shell provides a pneumatic (or hydraulic) path between the inside of the shell and the inside of the sleeve, ensuring that vaginal or abdominal pressure applied to the sleeve can be detected by a pressure sensor mounted on a printed circuit board inside the outer shell. Preferably, the outer shell is rigid, and the sleeve is formed from silicone or other suitable material for expansion by inflation. 
     Like the first device, the second implantable device also has a magnet and a coil. Preferably, the outer shell of the second implantable device has a flattened portion near which the magnet and coil are situated, preferably inside the device. The magnet of the second implantable device, when the second device is deployed in the patient&#39;s vagina, is of opposite polarity to the magnet in the first implantable device, when the first implantable device is deployed in the patient&#39;s bladder, and attracts the magnet of the first implantable device to maintain the first device in proximity to the second device to effect an inductive coupling between the coils of the first and second devices so that the first device may be powered by the power source of the second device without the need for a separate battery being housed within the first device. The omission of a battery allows the first device to be made quite small. 
     The magnets not only couple the two implantable devices together in proximity to one another, but they also are used to orient the first device in a particular manner. The sensor in the first implantable device, which is used for sensing a physiological property within the bladder, is situated at the opposite side of the housing from where the magnet is situated. Thus, the attraction between the magnets of the first and second implantable devices causes the first implantable device to be oriented in such a way that the device in the patient&#39;s bladder is held within the bladder at a particular location, without migrating within the bladder, and is kept with the sensing component end pointed away from the bladder wall, thereby minimizing possible obstruction of the sensing component and inaccurate measurements. Also, slightly negative buoyancy in the first implantable device keeps the first device from floating to the top of the bladder. 
     As mentioned previously, the first implantable device includes one or more sensing components for sensing a physiological property within the bladder, and a data storage element for storing data representing the physiological properties sensed by the sensor. It does not include a power source, but rather an inductive coil, which is used in conjunction with the second implantable device and is powered by the battery in the second implantable device through the inductive coupling between the two devices. 
     Preferably, the first implantable device of the present invention has a magnet which is cylindrical in shape that is mounted concentrically within the inductive coil situated in the first device. Both the coil and the magnet are mounted at the posterior end of the first implantable device to ensure that the magnet and coil are held against the bladder wall adjacent or in proximity to the magnet and coil of the second implantable device deployed in the patient&#39;s vaginal canal. 
     The second implantable device receives transmitted data from the first implantable device into its volatile memory. The second device acquires and stores abdominal pressure data or other data sensed by either the first device or the second device. 
     The urodynamic system of the present invention may further include an external module or data processing unit. This data processing unit receives the stored data from either or both of the first and second implantable devices that is transmitted to the data processing unit for analysis and ultimate treatment of bladder function. 
     A method for urodynamic evaluation, in accordance with the present invention, includes the steps of deploying a first implantable device within a patient&#39;s bladder, the first device including at least one sensor for sensing a physiological property within the bladder and having a first induction coil and a first magnet. The method also includes the step of deploying a second implantable device within the patient&#39;s vagina. The second device includes a power source, a second induction coil and a second magnet. 
     The method further includes the step of magnetically attracting the first magnet of the first implantable device with the second magnet of the second implantable device to maintain the first device in proximity to the second device. This effects an inductive coupling between the first inductive coil of the first device and the second inductive coil of the second device so that the first device may be powered by the power supply situated in the second device, without the need for a separate power source to be housed by the first implantable device. 
     These and other objects, features and advantages of the present invention will be apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an isometric view of one component (i.e., a first implantable device) of an implantable urodynamic system formed in accordance with the present invention, with the outer housing of the first implantable device shown in phantom to view the internal components thereof. 
         FIG. 2  is an exploded isometric view of another component (i.e., a second implantable device) of an implantable urodynamic system formed in accordance with the present invention. 
         FIG. 3  is an isometric view of the first implantable device and the second implantable device of the urodynamic system of the present invention, and illustrating the preferred operational orientation of the first and second devices. 
         FIG. 4  is an enlarged isometric view of a proximal end portion of the second implantable device of the present invention. 
         FIG. 5  is an enlarged isometric view of a distal end portion of the second implantable device of the present invention. 
         FIG. 6  is a cutaway isometric view of the implantable urodynamic system of the present invention. 
         FIG. 7   a  is a cutaway view of a patient&#39;s body and illustrating the second implantable device of the present invention in a first stage of deployment in the vagina of the patient. 
         FIG. 7   b  is a cutaway view of a patient&#39;s body and illustrating the second implantable device of the present invention in a second stage of deployment in the vagina of the patient, that is, with the sleeve inflated. 
         FIG. 7   c  is an isometric view of the first implantable device of the present invention and an insertion tool used for deploying the first implantable device in a patient&#39;s body. 
         FIG. 7   d  is a cutaway view of a patient&#39;s body and illustrating the first implantable device of the present invention in a first stage of deployment in the bladder of the patient. 
         FIG. 7   e  is a cutaway view of a patient&#39;s body and illustrating the first implantable device of the present invention in a second stage of deployment in the bladder of the patient. 
         FIG. 7   f  is a cutaway view of a patient&#39;s body and illustrating the first implantable device and the second implantable device of the implantable urodynamic system of the present invention deployed respectively in the bladder and vagina of the patient. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is an improved and robust implantable device and system that effectively captures ambulatory urodynamic data for assessment of urinary incontinence. The system preferably employs Micro Electro-Mechanical System (MEMS) technology, which relates to a class of small devices that integrates tiny mechanical and electrical components on a silicon chip. 
     Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. For example, although the present invention is described in detail in relation to the female urinary system, it is to be understood that it can be readily adapted for use in the male urinary system. Further, the inventive principles, apparatus and methods disclosed herein may also have application to assessing functionality in other areas, such as coronary or pulmonary functionality. 
     Initially referencing  FIG. 3  of the drawings, the present invention is an implantable urodynamic system  2 . The implantable urodynamic system  2  includes two implantable devices, a first implantable device  4  and a second implantable device  6 . The first implantable device  4  is sized and designed for implantation into a patient&#39;s bladder. The second implantable device  6  is specifically sized and designed for implantation into a patient&#39;s vagina. The first implantable device  4  and second implantable device  6 , operate together to form and define the implantable urodynamic system  2  of the present invention. 
     Now referencing  FIG. 1 , it will be seen that the first implantable device  4  includes a housing  8  with an internal cavity  10 . The housing includes two axial ends: a posterior end  12  and an anterior end  14 . An inductive coil  16  is mounted within the internal cavity  10  of the housing  8  at the posterior end  12 . Also, a magnet  18  is mounted concentrically with respect to the inductive coil  16  within the internal cavity  10  at the posterior end  12 . The first implantable device  4  may also include one or more sensing components  20  for sensing the physiological properties of the bladder, and a data storage element  22  for recording such properties. A printed circuit board  24  is mounted along the axial plane of the first implantable device  4  within the internal cavity  10 . The sensing component  20 , data storage element  22  and additional electronic components, such as a transmitter  102  which transmits stored physiological data either to the second implantable device or, more generally, to a point outside the bladder, may be secured to the printed circuit board  24 , specifically with the sensing component  20  mounted towards the anterior end  14  of the housing  8 . 
     Turning now to FIGS.  2  and  4 - 6 , the second implantable device  6  of the present invention includes an outer shell  26 . The outer shell  26  may include a first shell portion  28  and a second shell portion  30  which cooperatively securely mates together. The outer shell  26  may be constructed of a variety of materials but is preferably made of a polycarbonate material. The outer shell  26  has a proximal axial end  32 , a distal axial end  34 , a ventral surface  36 , and an opposite posterior surface  38 , and defines an internal cavity  40  for housing electronic components. The outer shell  26  preferably is generally cylindrical in shape; however, the ventral surface  36  is flattened to help ensure its proper orientation with respect to the first implantable device  4 . The proximal end  32  of the outer shell  26  is squared off in shape (less rounded than the distal end  34 ) with a bilaterally flattened tab  42  formed perpendicular to its surface and extending therefrom, which cooperates with a complementary-shaped insertion tool (not shown). The bilaterally flattened tab  42  includes a central bore  44  formed through the thickness of the outer shell and extending into the internal cavity  40  for receiving a pressurization tube  84  for inflating an outer sleeve  54 . The proximal end  32  of the outer shell  26  may further include a plurality, but preferably two, casing bores  46  formed through the thickness of the outer shell  26  for receiving casing screws  86 . 
     As can be seen in  FIGS. 5 and 6 , the distal end  34  of the outer shell  26  of the second implantable device  6  is generally rounded, but with a flattened axial tip  48 . Within the flattened tip  48  is a formed pressure bore  50  through the thickness of the outer shell  26  and into the internal cavity  40 . Internally extruded from the outer shell  26  at the distal end  34  is a plurality, but preferably two, internally threaded casing housings  52  that align with the casing bores  46  in the proximal end  32  and which are engaged by the ends of the casing screws  86  when the second implantable device  6  is assembled. 
     A thin walled inflatable sleeve  54  conforming to the shape of the distal end  34  of the outer shell  26  of the second implantable device  6  is fitted over the distal end  34  of the outer shell  26 . The inflatable sleeve  54  has variable thickness walls  55  that direct the sleeve  54  to inflate radially when pressurized and minimize elongation. The sleeve  54  has an inner surface  56 , an outer surface  58  and a flattened tip  59 . The outer surface  58  of the sleeve  54  may include a plurality of circumferentially spaced apart, radially outwardly extending ribs  60  extending along the length of the sleeve  54  or a portion thereof and/or surface texturing to limit the sleeve&#39;s longitudinal extension when inflated and resist rotation of the implantable second device  6  when deployed in the patient&#39;s vagina. The sleeve  54  also may include a sealing gasket  62  that is received in a groove situated between the mating edges of the upper and lower shell portions  28 ,  30  to insure a fluid tight seal between sleeve  54  and shell  26 . 
     The second implantable device  6  may also include a power source  64 , such as one or more batteries, a pressure sensor  66 , a data storage element  68 , and a data retrieval device  70 , as well as other electronic components, such as a transmitter  104  that transmits data to a point outside the patient&#39;s vagina. A printed circuit board  72  having a bottom side  74  and a top side  76  is mounted along the axial plane of the second implantable device  6  within the internal cavity  40 . The power source, preferably a battery  64 , a photo diode  78 , the pressure sensor  66 , the data storage element  68 , and the data retrieval device  70  are mounted to the bottom side  74  of the circuit board  72 . A magnet  80  and an inductive coil  82  are preferably mounted on the top side  76  of the circuit board  72  facing and in close proximity to the flattened ventral surface  36  of the outer shell  26 , with the magnet  80  preferably being disposed concentrically within the confines of the inductive coil  82 . 
     The assembly of the second implantable device  6  is described as follows. The inflatable sleeve  54  is fitted over the first shell portion  28  with the sealing gasket  62  extending over the open end of the first shell portion  28 . A pressurization tube  84  is inserted through the central bore  44  of the tab  42 . The second shell portion  30  is aligned with the first shell portion  28  and the casing screws  86  are inserted through the casing bores  46  in the second shell portion  30  and into the internally threaded casing housings  52  of the first shell portion  28  to secure the two shell portions together, with the sealing gasket  62  fluidtightly held therebetween. 
     Now turning to  FIGS. 7   a - 7   f , the deployment of the first implantable device  4  and the second implantable device  6  of the urodynamic system of the present invention will be described in detail. The second implantable device  6  is inserted into the vaginal canal  90  with its inflatable sleeve  54  deflated. Once the second implantable device  6  is in a desired position in the vaginal canal, it is inflated by pressurizing the pressure tube  84 , which in turn pressurizes the internal cavity  40  of the outer shell  26 . Pressure equalizes by exiting the pressure hole  50  in the distal end  34  of the outer shell  26  and into the flattened tip  59  of the inflatable sleeve, causing the radial inflation and expansion of the inflatable sleeve  54 , as the air is trapped in the space between the sleeve  54  and the outer shell  26  by the sleeve seal  62 . The expansion of the inflatable sleeve  54  secures the second implantable device  6  within the vagina  90 . 
     The first implantable device  4  is implanted into the bladder  87  through the urethra using an insertion tool  88 . As illustrated in  FIG. 7   f , once both devices are implanted, the magnet  18  in the posterior end  12  of the first implantable device  4  is attracted to the magnet  80  of opposite polarity located in proximity to the ventral surface  36  of the second implantable device  6 . The magnetic attraction between the first and second devices  4 ,  6  keeps the devices in close proximity to each other and properly oriented to effect an inductive coupling between the coils  16 ,  82  of the two devices. The electronics of the first implantable device  4  are powered by the power source  64  of the second implantable device  6  by using the inductive coupling between the inductive coil  16  located within the posterior end  12  of the first implantable device  4  and the inductive coil  82  in proximity to the ventral surface  36  of the second implantable device  6 . 
     During operation, the location of the magnet  18  in the posterior end  12  of the first implantable device  4  insures that the posterior end  12  is held against the bladder  87 , adjacent or in close proximity to the magnet  80  in the second implantable device  6 . Additionally, the location of the magnet  18  points the sensing component  20  away from the wall of the bladder  87 , thereby minimizing possible obstructions and erroneous data measured by the sensing component. The first implantable device  4  of the present invention also exhibits a negative buoyancy to help keep the device  4  from floating to the top of the bladder  87 . The first implantable device  4  can be used to measure and transmit a variety of data, including but not limited to bladder pressure, temperature data, urination flow rate, and patient acceleration. These measurements can be performed while the patient remains ambulatory. 
     The second implantable device  6  can also be used to measure, transmit and store a variety of data, including abdominal and vaginal pressures. The second device  6  also receives the transmitted data from the first implantable device and stores it in its storage element  68 . All the data stored in the second implantable device  6  can be transmitted to an external module or circuit  100  for analysis and corresponding treatment of a bladder condition, in the same or similar manner as that known to one skilled in the art, such as described in the aforementioned Tracey et al. U.S. patent application Ser. No. 11/043,830. 
     Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention.