JP2019504711A - Apparatus and method for screening a patient for bladder control via pudendal nerve stimulation - Google Patents

Abstract

Embodiments of the present invention provide devices and methods for testing the effectiveness of neural stimulation therapy for treating patients with urethral dysfunction prior to implantation of the device to treat dysfunction. . The device and method selectively stimulates the pudendal nerve with high and low frequency currents to generate physiological responses involved in the micturition process (eg, urethral sphincter relaxation and bladder contraction), and then the response Provides a means for measuring relevant information. Certain embodiments have the ability to control bladder excretion by filling the bladder and applying a stimulation current to the pudendal nerve and then measuring response information such as bladder pressure, urethral sphincter pressure, and urethral flow velocity. Including the introduction of a urinary catheter configured to perform both of the tests. The catheter can include at least two electrodes and a separate pressure sensor positioned to measure urethral sphincter and bladder pressure.

Description

CROSS REFERENCE TO RELATED APPLICATION This application claims priority benefit under US Provisional Application No. 62 / 294,613, filed February 12, 2016 (Attorney Docket No. 42197-739.101) This application is also a continuation-in-part of US patent application Ser. No. 15 / 153,314 filed on May 12, 2016; the entire contents of these applications are hereby incorporated by reference in their entirety. Is done.

This application is also related to US patent application Ser. No. 15 / 410,692, filed on Jan. 19, 2017, which is incorporated herein by reference for all purposes. .
BACKGROUND OF THE INVENTION Field of the Invention. The present invention relates to medical devices and methods. More specifically, the present invention relates to systems and methods for screening patients with paralysis and incontinence and determining whether they can benefit from pudendal nerve stimulation to control urethral function.

  Many disorders can result in a loss of the patient's ability to spontaneously control bladder function. Most commonly, patients suffering from spinal cord injury can lose not only the ability to spontaneously control urination but also the ability to sense it when the bladder is full. Such patients need to rely on the chronic use of a urinary (foley) catheter, usually placed through the urethra and having a distal tip that resides in the bladder. Such Foley catheters present a certain risk of infection, which is exacerbated by the frequent need to replace clogged catheters with new ones. In addition, the Foley catheter usually drains into the bag, which must be transported when the patient leaves the home or treatment facility. The need to transport a drain bag is a significant burden for many patients.

  In order to overcome these problems, at least in part, a very promising new system has been proposed that allows patients and their caregivers to selectively stimulate the pudendal nerve and excrete from the bladder. Makes it possible to control. Such a system can eliminate the need for a Foley catheter and is described, for example, in US Patent Publication No. 2014/0249595, the entire disclosure of which is hereby incorporated by reference.

  Although a significant advance, such pudendal nerve stimulation systems require surgical implantation of stimulation electrodes in the vicinity of the pudendal nerve, and the system is not always successful and for removal A second surgical operation may be required.

  For these reasons, it would be desirable to provide an improved system and method for controlling urination via stimulation of the pudendal nerve. In particular, it would be desirable to provide an apparatus and method in which patient testing may allow such pudendal nerve stimulation to be effective and to determine the likelihood that an implantable surgical procedure can be warranted. I will.

  2. Background art description. US Patent Application Publication No. 2014/0249595 is described above. See also US Patent Application Publication Nos. 2014/0058284, 2014/0058588, and 2014/0309550.

US Patent Application Publication No. 2014/0249595 US Patent Application Publication No. 2014/0058284 US Patent Application Publication No. 2014/0058588 US Patent Application Publication No. 2014/03095950

SUMMARY OF THE INVENTION Embodiments of the present invention provide for the implantation of a neurostimulator that is intended to control urination in patients whose urination cannot be voluntarily controlled or otherwise reduced in ability. Prior to providing an apparatus and method for testing a patient. Such patients can include paralyzed patients or any patient with urethral dysfunction that interferes with its ability to control urination spontaneously. Certain embodiments of the present invention test patients and determine whether they would benefit from such an implanted neural stimulation therapy that allows the patient to control bladder excretion. Devices, systems, and methods are provided. Neural stimulation therapy, intended to control urination, typically requires the implantation of electrodes to stimulate the pudendal nerve, the controller, and cable leads or wiring between the controller and electrodes . By selectively stimulating the pudendal nerve with high and low frequency currents, the bladder contracts and the urethral sphincter is opened, allowing control of urination without the need for a Foley catheter to reside in the patient's urethra can do. However, it may be desirable to determine whether a patient is likely to benefit from pudendal nerve stimulation before implanting such a device. Various embodiments of the present invention provide that the stimulation protocol fills the bladder and applies a stimulation current to the pudendal nerve, one or more physiological conditions involved in the urination process, such as relaxation of the urethral sphincter and contraction of the bladder. By inducing or generating an effect, it can be mimicked using a temporarily introduced urinary catheter that can be used both for testing the ability to control bladder excretion . Embodiments of the present invention, in particular, i) selected systems and / or protocols for controlling and / or optimizing urination via electrical stimulation of the pudendal nerve control urination for a given patient. Ii) adjust or otherwise adjust one or more characteristics of the electrical stimulation and control the urethral function and / or control generated by pudendal nerve treatment for a particular patient Useful for optimizing or otherwise improving. Such characteristics may include one or more of the frequency, current, or voltage of the electrical stimulus used and the waveform of such stimulus.

  In a first aspect, the present invention provides a method for screening a patient and determining the likelihood that the patient will benefit from pudendal nerve stimulation therapy. A catheter is temporarily introduced through the patient's urethra and the distal end of the catheter enters the patient's bladder. The catheter is used to fill the bladder with a fluid such as water or saline, and at least one electrode on the catheter conducts current, typically in the patient's genital sphincter or in the vicinity of the patient's genital area. Located in the urethra at a location selected for delivery to the nerve. A low frequency current is delivered to the pudendal nerve using electrodes to contract the patient's bladder, and a high frequency current is delivered to the pudendal nerve to open the patient's urethral sphincter. Patients are able to deliver low and high frequency currents to successfully contract the bladder and open the urethral sphincter, and fluid introduced into the bladder in response to the delivered current. Is allowed to be excreted, it is likely to benefit from pudendal nerve treatment. In certain aspects of the method, the catheter may further include a first pressure sensor that allows the pressure in the bladder to be measured. Typically, the pressure sensor is at or near the distal end of the catheter and can lie inside the bladder. A first pressure sensor, located at or near the distal end of the catheter, is used as the bladder is filled and filled to the target pressure prior to the user delivering current and testing bladder excretion. Allows to monitor bladder pressure.

  Embodiments of the present invention contemplate various current delivery schemes that can be used to assess the effectiveness of pudendal nerve stimulation in controlling urethral function. Typically, high and low frequency currents can be delivered in parallel, but non-parallel delivery is also contemplated. Current delivery may be initiated simultaneously. However, in one or more embodiments, one may be started before the other and / or one may be stopped before the other. For example, according to one embodiment of a current delivery scheme, a high frequency current can first be delivered to relax the urethral sphincter. A low frequency current is then initiated and maintained for a selected period of time to contract and excret the bladder. The low frequency current is then stopped after a selected period, while the high frequency keeps the urethral sphincter open and allows the urine to continue to flow due to any residual contraction of the bladder To be continued. Finally, the high frequency current is also stopped and the urethral sphincter is closed.

  One, two, or all three of bladder pressure, sphincter pressure, and observed urine flow (qualitative and quantitative) are used to assess the potential for treatment potential. May be. In certain embodiments, one, two, or all three of these parameters may also be used to determine either or both of the optimum high frequency and the optimum low frequency current. May be used in subsequent treatments to select and / or generate a maximum urethral flow rate. For example, in one particular embodiment, one or both of bladder pressure and urethral flow rate are used by a therapeutic device that is subsequently implanted with therapeutic low and / or high frequency currents for a particular patient. It can be used to pre-select the low or high frequency to obtain. In another embodiment, one or both of urethral flow rate and urethral sphincter pressure can be used for such pre-selection. Thus, the selection and / or setting of implanted therapeutic devices is optimized to provide maximum urethral function to each patient before they have any implanted devices such as electrodes, wire controllers, etc. Can be done.

  In other embodiments of the present invention, at least two electrodes may be positioned on the catheter to deliver current to the pudendal nerve. The first electrode may be configured to deliver a low frequency current and the second electrode may be configured to deliver a high frequency current.

  In yet another embodiment of the invention, the contractile pressure exerted by the patient's urethral sphincter can be measured. Typically, the systolic pressure is measured by a second pressure sensor on the catheter, and the second pressure sensor and the first and optionally the second stimulation electrode are typically the electrodes and pressure sensors, respectively, When the distal end is in the bladder and is present in the urethra, it is positioned on the catheter body so that it is proximate to or within the urethral sphincter surrounding the urethra. Further optionally, the catheter can be positioned by retracting the catheter, such as a balloon on a Foley catheter, until the balloon or other anchor is seated against or in the bladder neck, etc. A balloon or other anchor structure may be included near its distal end. By selectively positioning the electrodes and the second pressure sensor, these elements are properly positioned relative to the urethral sphincter when the catheter is in place.

  In a second aspect, the present invention screens patients prior to pudendal nerve stimulation therapy, ie, screens patients for the effectiveness of pudendal nerve stimulation therapy prior to implantation of a therapeutic pudendal nerve stimulation device. A catheter is provided. The catheter includes a catheter body having a distal end, a proximal end, and a lumen for delivering fluid from the proximal end to the distal end. The catheter body is typically positioned at or near the distal end of the catheter body, and is typically positioned to measure pressure in the bladder when the catheter is in place in the urethra. A first pressure sensor is included. The catheter may further include at least one electrode positioned on the catheter body at a location proximal to the distal end of the catheter. In particular, the at least one electrode is positioned on the catheter so as to lie close to the urethral sphincter when the catheter is properly placed in the urethra. Thus, the catheter typically delivers fluid to the bladder through the catheter lumen, uses the first pressure sensor to measure pressure in the bladder, and delivers current to the pudendal nerve. Can be used to stimulate the bladder and contract and / or open the urethral sphincter by appropriately applying low and / or high frequency currents through electrodes located in the vicinity of the urethral sphincter .

  Screening catheters typically mimic actual therapeutic protocols that apply both high and low frequency stimulation signals simultaneously or nearly simultaneously, causing the sphincter muscles to relax and the bladder to contract simultaneously, resulting in urination. obtain. In an alternative embodiment, high frequency current may be delivered first to open the sphincter, and after a selected period of time, the low frequency current may continue to contract the bladder. In yet another alternative embodiment, a low frequency current is delivered first to contract the bladder, generating greater pressure for more complete excretion, followed by a low frequency after a selected period of time, and the urethral sphincter May be opened to allow excretion to begin.

  In certain embodiments, the catheter of the present invention further comprises at least a second electrode on the catheter body, located proximal to the first electrode, typically spaced proximally from the distal end of the catheter body. obtain. In these embodiments, the first and second electrodes are typically connected to different current sources capable of delivering a low frequency current to contract the bladder and a high frequency current to open the urethral sphincter. Can be configured. A suitable low frequency current that results in bladder contraction may be in the range of about 15 Hz to 50 Hz, with an ampere below 15 mA and a voltage of 40V-60V. Also, in one or more embodiments, the first and second electrodes deliver electrical current into the tissue at a selected depth to minimize the effect on the surrounding tissue and stimulate the pudendal nerve As such, a pair of bipolar electrodes may be provided that may be separated by a selected distance.

  In still other embodiments, the catheter of the present invention may further comprise a second pressure sensor on the catheter body at a location proximal to the distal end of the catheter body. Typically, the second pressure sensor has the first and second electrodes and the second pressure sensor adjacent to or in the urethral sphincter when the distal end of the catheter is in the patient's bladder. The first and optionally the second electrode may be positioned, for example, between the first and second electrodes.

  In a still further embodiment, the catheter of the present invention may comprise a deployable anchor such as a balloon similar to that found on a conventional Foley catheter and is positioned on the catheter body. When the anchor is deployed in the bladder neck, the anchor is positioned on the catheter body such that at least one electrode, optionally a second electrode, and a pressure sensor are adjacent to the pudendal nerve and urethral sphincter.

  In a third aspect, the present invention allows a catheter as described above to be operably connected to an electrode to open a low frequency current for deflating the patient's bladder and the patient's urethral sphincter. A system is provided comprising in combination with a controller for delivering high frequency current for. Typically, the controller can deliver a low frequency current to the first electrode and a high frequency current to the second electrode. The controller is further configured to present data from a first pressure sensor to indicate bladder pressure and / or data from a second pressure sensor to indicate sphincter compression pressure or force, More than that display or screen may be provided or connected to it.

  Further details of these and other embodiments and aspects of the invention are described more fully hereinafter with reference to the accompanying drawings.

FIG. 1 illustrates a method for selectively stimulating pudendal nerves and controlling urination obtained from US Patent Publication No. 2014/0249595, the entire disclosure of which is incorporated herein by reference. 1 illustrates a prior art system. In particular, FIG. 1 depicts a three channel system for stimulating the pudendal nerve or its branches. The pulse generator 10 is depicted as having three output channels. Wire leads 12 and 13 are attached to electrodes 14 and 15, which are placed around the pudendal nerve 20. Electrode 15 is shown distal to electrode 14. In the context of the method, including blocking the EUS and / or anal sphincter and stimulating or preventing contraction in the bladder and / or rectum, the electrode 14 is used to stimulate or prevent bladder and / or rectal contraction. While electrode 15 would be used to block the EUS or anal sphincter. Optionally, wire leads 16 are placed around the pudendal nerve on the other side of the body and attached to another electrode (not shown in FIG. 1) that blocks the pudendal nerve on the opposite side. The pulse generator 10 is shown implanted directly under the skin 40. The output parameters of the pulse generator 10 can be controlled via a wired interface, but preferably via any suitable wireless protocol such as radio frequency, IEEE 802.11a / b / g, Bluetooth®, etc. Controlled by wireless transmission, which can be carried using. Accordingly, the external controller 30 is depicted for communicating with the pulse generator 10. The external controller 30 is depicted as having a display 32 such as an LCD, LED, or OLED display and a keypad 34 for driving data into the external controller 30. Although the external controller is depicted as transmitting a wireless transmission 36 to the pulse generator 10, in another embodiment, data is transferred from the external communicator 30 to the pulse generator 10 and vice versa. Enabling monitoring of one or more parameters of the pulse generator 10, including but not limited to output signal characteristics (eg, frequency, amplitude, etc. as outlined above) and battery strength. it can. The activity of the pulse generator 10 and external controller 30 is typically controlled by a microprocessor, and software / firmware installed on the pulse generator 10 and external controller 30 hardware implements the tasks described. For example, but not limited to, may be used to provide a graphical user interface (GUI) for display 32 that facilitates use of the system. Both the pulse generator 10 and the external controller 30 comprise any suitable electrical and electronic components, such as a microprocessor, memory (eg, RAM, ROM, flash memory, etc.), connector, battery, power transformer, amplifier, etc. Activities may be implemented, including FIG. 2 illustrates an exemplary embodiment of a test catheter constructed in accordance with the principles of the present invention. FIG. 3 illustrates the test catheter of FIG. 2 for performing a test protocol placed in a patient's urethra according to the method of the present invention. FIG. 3a is an enlarged view of FIG. 3 illustrating the positioning of the test catheter electrode within the patient's urethral sphincter to stimulate the patient's pudendal nerve. 4a and 4b illustrate an embodiment of a test catheter having a second lumen for fluid flow from the bladder to the outside of the patient. 4a and 4b illustrate an embodiment of a test catheter having a second lumen for fluid flow from the bladder to the outside of the patient. FIG. 5 illustrates an embodiment of a bipolar electrode for use as a pudendal nerve stimulation electrode for use with a test catheter embodiment.

DETAILED DESCRIPTION OF THE INVENTION Embodiments of the present invention test patients who cannot and / or have reduced voluntary control of urethral function, and the patient being tested controls the patient's bladder excretion. Devices, systems, and methods are provided for ascertaining whether or not to enable or benefit from pudendal nerve stimulation therapy. Such patients may include patients who are paralyzed due to spinal cord injury and / or patients with multiple sclerosis or other motor neuron diseases. Particular embodiments of the present invention include US 2014/0249595 (incorporated herein by reference) and a co-pending book filed on January 19, 2016. By an implantable device for providing bladder control, such as that described in US Provisional Application No. 62 / 280,639 owned by the Applicant (the entire disclosure is incorporated herein by reference) A device is provided that mimics what is provided, and the method of the present invention allows testing of a bladder stimulation protocol.

  Referring now to FIGS. 2, 3a, 4a-4b, and 5, an embodiment of a test catheter 200 stimulates a catheter body 202 having a distal end 204 and a proximal end 206, and the pudendal nerve PN, and the bladder And at least two electrodes 228 and 230 for inducing or otherwise generating a physiological response involved in the micturition process, such as urethral contraction and urethral sphincter relaxation. The catheter body is known in the art including, for example, HDPE (high density polyethylene), LDPE (low density polyethylene), Pebax® polymer, PTFE, silicone, polyurethane, or other elastomers known in catheter technology. May be made from a variety of flexible biocompatible polymers. A lumen 210 having a port 208 at the distal end of the catheter body 202 is fluidly connectable to a fluid source 212 through a port 226 on the proximal hub 224 of the catheter. As shown in FIGS. 4a and 4b, in an alternative or additional embodiment, the test catheter 200 is also for fluid flow from the patient's bladder B to the outside of the body, as described in more detail below. A second lumen 211 may be included to facilitate excretion and allow measurement of urine flow rate. In various embodiments, the fluid source 212 may be saline, water, when the distal end 204 of the catheter 200 is in the bladder B, as illustrated in FIG. 3a, described later herein. Or any other suitable pressurized fluid can be delivered to the patient's bladder through lumen 210, a suspended fluid bag (eg, a premixed saline solution bag), or any Other conventional fluid sources may be accommodated.

  Referring now to FIGS. 3a and 5, electrodes 228 and 230 may include various biocompatible conductive metals and other conductive materials known in the medical device and electrophysiology arts. In various embodiments, the electrodes 228 and 230 may correspond to various ring electrodes, with a selectable width selected to achieve a desired penetration depth through the urethral sphincter tissue to the pudendal nerve, for example 1 You may have -10 mm. The spacing S between the electrodes 228 and 230 is desirably selected to position these electrodes inside the urethral sphincter US, as shown in FIG. 3a.

  As shown in FIG. 5, in alternative or additional embodiments, pudendal nerve stimulation electrodes 228 and 230 may correspond to individual pairs 242 of bipolar electrodes 240. Each pair of bipolar electrodes 242 includes first and second electrodes 243 and 244, through which alternating current or other current may flow. The distance or gap 245 between each individual electrode 243 and 244 of the bipolar pair 240 controls the penetration depth of the stimulation current flow between them, selectively avoiding any surrounding tissue while avoiding any surrounding tissue. It may be selected to be targeted. Longer distances tend to produce deeper penetrations, while shorter distances become shallower. In various embodiments, the gap 245 can range from about 1-5 mm, although longer and shorter gaps are also contemplated. This gap may also be selected depending on whether the current is a high frequency or low frequency current, as described herein.

  According to one or more embodiments, the catheter body 202 and / or lumen 210 or other lumen 211 can be a catheter using fluid sensors within individual lumens using sensor sensors 214 and 232 or another sensor. 200 may be sufficiently rigid (eg, radial stiffness or stiffness) to prevent it from significantly affecting the pressure measurement of bladder pressure and / or urethral sphincter contraction pressure by 200, and / or It may have sufficient hoop strength. “Significantly” means an impact on pressure below about 10%, more preferably below about 5%, even more preferably below about 1%. More specifically, one or more lumens of the catheter 200 (here, the lumen wall as well) is desirably inside the lumen, which may affect measurements by the catheter 200. Rigid enough to minimize or prevent transmission of force from fluid pressure to the outside of the catheter. Desirably, the transmitted force is less than 0.2 pounds, more desirably less than 0.05 pounds, and even more desirably less than 0.01 pounds force. Similarly, lumens 210, 211 also affect pressure measurements and / or constrict fluid in adjacent lumens and can significantly affect flow rates through adjacent lumens. Be sufficiently rigid to minimize pressure transmission. In other words, these lumens prevent hydrostatic pressure crosstalk from one lumen to the next, and prevent pressure within one lumen from constricting adjacent lumens. Is sufficiently rigid for. They are also sufficiently rigid to maintain their shape from application of force to adjacent lumens or when the catheter body is positioned and bent within the patient's urinary tract. However, preferably, the catheter 200 and catheter body 201 as a whole may remain sufficiently extensible to be advanced and manipulated within and through the intended patient anatomy for clinical use scenarios. In a specific embodiment, the catheter lumens 210 and 211 have any change in pressure or flow rate in one lumen resulting from pressure or pressure changes in adjacent lumens, preferably less than about 5%. Preferably it has sufficient stiffness or hoop stress so that it will remain below 2%, even more preferably below 1%. In various embodiments, such firmness or hoop strength can be achieved by any one or more of the following. (1) choice of catheter material, (2) catheter / lumen dimensions, (3) use of reinforcing braids (inside and outside of the lumen), and / or (4) internal reinforcing lumen. In various embodiments, the radial stiffness of any one of lumens 210, 211, or other lumens of catheter 200 (also described herein as radial stiffness) is about 1 To about 100 N / mm, more preferably in the range of about 20 to about 100 N / mm, even more preferably in the range of about 50 to about 100 N / mm, specific embodiments being 5, 10, 20, 25, 30, 40, 45, 50, 55, 60, 70, 75, 80, 90, and 95 N / mm, while the hoop strength is about 0.25 to 5 pounds, and more Preferably, it can be in the range of about 0.5 to 5 pounds, even more preferably about 1 to 10 pounds, and specific embodiments are 0, 5, 1, 2, 2, 5, 3, 4, 5, 6, 7, 8, and 9 pounds of force.

  In one or more embodiments, the catheter 200 may also include a first pressure sensor 214, typically also located at or near the distal end 204 of the catheter body 202, but for the pressure sensor It should be understood that other locations on the catheter body are also contemplated. The first pressure sensor 214 is typically a variety of solid state pressure transducers suitable for measuring pressure in the bladder (e.g., various known in the art, including microelectromechanical system based strain gauges). Solid state strain gauges), typically in the range of 0-50 mm Hg, although other ranges are also contemplated. Normal bladder pressure is in the range of 0-10 mm Hg, or sometimes 0-20 mm Hg, but the methods of the invention may rely on delivery and measurement pressures above normal bladder pressure. The bladder pressure read by the transducer 214 may be displayed on read information 218 on the controller 216 or using Bluetooth® or Bluetooth® LE or other wireless communication protocol and / or wireless means Then, it may be wirelessly transmitted to an external display. The reading information 218 may be a dedicated LCD, LED, or other numeric or analog reading information, or may be part of a display screen, optionally a touch screen display. Catheter 200 is optionally used to stabilize the catheter body 202 and properly position the electrodes 228 and 230 at or near the patient's urethral sphincter, as will be described in more detail with respect to FIG. 3a below. It may include a distal anchor, such as an inflatable balloon 220, that is positionable within the bladder. A second pressure transducer 232 can often be provided in the vicinity of electrodes 228 and 230 to allow measurement of urethral sphincter contraction pressure. Pressure sensors 214 and 232 and electrodes 228 and 230 may be connected by wires or cables 238 that pass through the catheter body and connect electronic components to controller 216. They may also be wireless devices configured to communicate with the controller 216 via Bluetooth® or other wireless protocol. Balloon 220 can be inflated by a conventional inflation source 222 of the type normally used with Foley catheters. The sphincter pressure measured by the second pressure transducer 232 may be shown on the second display element 234 on the controller 216, or also on a conventional touch screen or other display on the controller. May be. The controller 216 typically may also include a user interface 236. According to various embodiments, user interface 236 can be a touch screen (which can be the same touch screen for displaying all data), a keyboard, a joystick, or any other conventional user interface. Well this may be directly or wirelessly coupled to the controller.

  Referring now to FIG. 3, the catheter 200 of FIG. 2 is adapted so that the anchor balloon 220 can be positioned in the patient's bladder B and rest above or within the bladder neck BN. May be introduced through. Dimensions for the catheter are such that the electrodes 228 and 230 and the second pressure sensor 232 are generally positioned within the patient's urethral sphincter US to stimulate the pudendal nerve PS, as best shown in FIG. 3a. May be selected.

  In one or more embodiments, the length of the catheter 200 and its components and other dimensional adaptations can be made with respect to the patient's gender. For example, in the case of a catheter 200 adapted for the male urinary tract, the second sensor 232 for measuring urethral contraction pressure is a catheter approximately 2.5 cm to 3.5 cm proximal to the distal end 204 of the catheter. It may be positioned on the body 201 and extend to about 2.0 cm of the urethral length. In the female version of the catheter, the sensor 232 is located approximately 1.8-3 cm proximal to the distal catheter end 204 and extends approximately 1.5 cm of the urethral length.

  In the position shown in FIG. 3, the catheter 200 initially fills the bladder and pressurizes to the desired target level, typically about 10 mmHg to about 45 mmHg, a preferred range of about 10 to about 20 mmHg. Or it may be used to introduce a fluid such as saline into the bladder B. In related embodiments, the catheter 200 may be used to fill the bladder to a target volume, for example, in the range of about 50-200 ml. As used herein, the term “about” means within ± 10% of the stated value with respect to parameters, measurements, dimensions, properties, physical properties, and the like. Once bladder B is filled to the desired pressure and / or with the desired volume of fluid, a low frequency bladder contractile current, typically having a frequency of about 15 Hz to about 50 Hz, stimulates the pudendal nerve PN. And may be applied through the first electrode 228 to cause bladder contraction. Simultaneously or nearly simultaneously (eg, within about 0.2 seconds in this case), a high frequency urethral sphincter relaxation current may be applied by the second electrode 230 to cause relaxation and release of the urethral sphincter. In some embodiments, the high frequency current allows the urethral sphincter to relax and fully open before the bladder contracts from the low frequency current, and the fluid resistance in the urethra to the bladder contraction is May be initiated at a selected time prior to the low frequency current (e.g., about 0.2-2 seconds) such that is minimized before it begins to contract. Typically, the high frequency current has a frequency above 4 kHz, the amperage is below about 15 mA, the voltage is in the range of 40V-60V, and the specific range for the high frequency current is 4 10 kHz, 4-15 kHz, and 4-20 kHz can be included, but still other ranges are contemplated. When high and low frequency currents are applied, bladder contraction and urethral sphincter opening cause the patient to urinate (also referred to herein as excretion) through the annular urethral space surrounding the catheter 200. to enable.

  In alternative or additional embodiments, any second sting, burning sensation, numbness, or second high frequency current, typically above 1 kHz, caused by current delivery to the pudendal nerve by electrodes 228 and 230, or It may be delivered by the catheter 200 to the pudendal nerve to block or otherwise attenuate related sensations (known as sensory abnormalities). This current, described herein as sensory anomaly blocking current, may be delivered by either or both electrodes 228 or 230, or a third electrode on or outside of catheter 200 (not shown). May be delivered by. Desirably, the sensory anomaly blocking current is generated by a different current source than that used to generate the first two currents (eg, bladder contraction and sphincter relaxation current). In various embodiments, the sensory abnormality blocking current may have a frequency in the range of 1.5 kHz to 100 kHz, more preferably in the range of about 3 kHz to 20 kHz. In one or more embodiments, the sensory anomaly blocking current waveform is a biphasic pulse having a pulse width in the range of 10 microseconds to 333 microseconds, more preferably in the range of about 30 to 35 microseconds. May correspond. The amplitude can be varied from about 1 mA to about 4 mA, with a nominal value of about 2.5 mA. These and other characteristics of sensory abnormality blocking currents are similar to the regulation of current to contract the bladder and relax the urethral sphincter, in a manner similar to the patient feedback on perceived sensory abnormalities, and / or bladder pressure, urethra Based on one or more of sphincter contraction pressure and urethral flow velocity measurements, adjustments or fine adjustments or otherwise can be made. Thus, embodiments of the present invention are such that the pudendal nerve stimulation device is implanted so that the patient has a better outcome than if the pudendal nerve stimulation device was pre-programmed with a standard sensory abnormality block current. Before, it can be used to optimize the sensory abnormality blocking current.

  Reference is now made to FIGS. 4a and 4b. In alternative or additional embodiments, the catheter 200 includes an additional lumen or other channel 211 to allow excretion or urination through the lumen 211 while the catheter 200 is positioned at a desired location in the patient's urinary tract. Can be promoted. Lumen 211 can include one or more distal openings 211o for fluid flow from the bladder into the catheter. Desirably, the opening 211o is distal to the catheter so that the opening 211o is slightly above the bladder neck and anchor device 220 to facilitate fluid flow into the catheter and complete excretion of the bladder. Located at a selected distance proximal to the distal end 214. Again, as discussed herein, the lumen 211 is sufficiently radially stiff to maintain its shape when the catheter is bent and / or subjected to fluid pressure from the lumen 210. Degrees (eg, through the use of reinforcing braids). In use, an embodiment of a catheter having a dedicated lumen 211 for fluid flow from the bladder, all of the urine flow proceeds through the catheter while the pudendal nerve is stimulated by the electrode 230 to induce urination, As flow rate or total volume can be measured, it facilitates a more accurate measurement of urine flow rate. Measurements are made manually (by timing and collecting the excreted fluid) or using a flow sensor, which can be an external sensor located across the catheter or at the proximal end of the catheter. Can do. According to some embodiments, the catheter 200 may include its own flow sensor 235 that may be positioned in or around the lumen 211 or the catheter body 20. The flow sensor 235 may also be operably coupled to the controller 216 to communicate information regarding urine flow to the controller. The flow sensor 235 may correspond to various electromagnetic, optical, anemometric, and acoustic flow sensors known in the art, including various solid state flow sensors. In a more specific embodiment, the measured urine flow rate is, for example, high and low frequency current, including amplitude (either voltage and / or current), frequency, pulse width, as described herein. May be used to adjust one or more of the properties. Suitable target urine flow rates for men and women are shown in Table 1. In various embodiments, fluid resistance within lumens 211 (including for individual catheters 210) at flow rates and bladder pressures corresponding to their typical during urination is measured in advance and catheters Can be stored in a memory device that is shipped with and configured to be operably coupled to the controller 216. Alternatively, they may be calculated for a standard diameter lumen 211 and stored in the controller 216. Such fluid resistance then converts the fluid flow rate through lumen 211 resulting from induced bladder excretion into a velocity that would be expected through the urethra in the case of a catheter 200 that is not positioned in the patient urinary tract. Can be used to.

  As discussed herein, in these and related embodiments, the first lumen 210 (including the lumen wall 210w) can be different during fluid flow for the lumen 210 to fill the bladder. When subjected to pressure, it does not cause any significant radial deformation of the diameter of the additional lumen, but a significant amount (eg, less than 10%, more preferably less than 5%, even more preferably less than 1%). ) With sufficient radial stiffness or otherwise reinforced to reduce the urine flow rate through the second (urine outflow) lumen. In addition, the second pressure transducer 232 is desirably configured to measure a decrease in urethral sphincter pressure as the sphincter relaxes. Observation / measurement of urine passage and optionally a decrease in sphincter pressure indicates that the patient is responding to favor pudendal nerve stimulation and is a good candidate for a complete implantation procedure. This and other information regarding physiological responses to delivered high and low frequencies or other currents can be used as a basis for assessing the effectiveness of pudendal treatment.

  In one or more embodiments, various information collected using the catheter 200 or other measurement means related to the physiological response generated from pudendal nerve therapy treats the patient's urethral dysfunction. It can be used as a basis for assessing the effectiveness of treatment in doing (eg, allowing urination to be initiated and controlled). Such information may also be used to adjust one or more characteristics of high and low frequency currents to optimize pudendal nerve therapy for a particular patient. According to various embodiments, such criteria can include one or more of urine flow rate, decreased urethral sphincter pressure, and increased bladder pressure. For urine flow, a minimum flow rate within 0-30% of the values shown in Table 1 may be used. In the case of urethral sphincter pressure, a pressure reduction of about 50, 60, 70, 75, 80, 90, or 95% (other values are also contemplated) may be used. Further, in the case of bladder pressure, an increase in amount of about 10, 20, 30, 40, 50, 60, 70, 80, 90, 95% (other values are also contemplated) may be used.

  In certain embodiments, one or all three of urine / excretion flow rate, decreased urethral sphincter pressure, and increased bladder pressure are to be used in subsequently implanted genital treatment devices at high frequencies and low It may be used to preselect both frequency currents. In particular, high and low frequencies are “adjusted” while observing or tracking changes in urine flow rate to identify selections and / or their settings that result in maximum urine flow rate and / or shortest urination duration. Or “fine adjustment” (fine adjustment). Specific adjustments may be made in one or more characteristics of high and low frequency currents, including frequency, wave current or voltage, and wave shape. In particular, the adjustment may be made at the peak amplitude of the current or voltage as well as the RMS amplitude. Different waveforms may also be employed including, for example, sine waves, square waves, and sawtooth waves. Also, in one or more embodiments, the waveform may be in the form of a biphasic pulse with a selectable pulse width, eg, 1-100 ms.

  Rough adjustments may incorporate changes that are in the range of about 5 to about 25%, while fine adjustments may be less than about 5%. For example, in one particular embodiment, one or more of bladder pressure and urine flow rate adjust and fine tune the low frequency current for a particular patient and select for a particular patient. And / or can be used to generate an optimized urine flow rate and / or an optimized micturition sequence (eg, timing of bladder contraction and urethral sphincter relaxation). In another embodiment, one or both of the urine flow rate and urethral sphincter pressure adjust and fine tune the high frequency current to select and / or optimize urine flow rate and / or optimized for a particular patient. Urination sequences (eg, timing of bladder contraction and urethral sphincter relaxation) can be used. Thus, not only can candidates be selected for pudendal nerve stimulation treatments to enable or improve urethral function, but also urethral functions achieved by embodiments of pudendal nerve stimulation treatments can also be Prior to having any implanted device, such as a wire, controller, etc., can be optimized for each patient. This in turn should improve the final clinical outcome of the candidate patient for pudendal nerve stimulation treatment and also remove and / or reimplant electrodes and other components of the pudendal nerve stimulation system Reduce the risk of morbidity and mortality from need.

  The foregoing descriptions of various embodiments of the present invention have been presented for purposes of illustration and description. This is not intended to limit the invention to the precise form disclosed. Many modifications, variations, and refinements will be apparent to those skilled in the art. For example, device embodiments can be sized and otherwise adapted for various pediatric and various veterinary applications. Those skilled in the art will also be able to recognize or confirm numerous equivalents of the specific devices and methods described herein using only routine experimentation. Such equivalents are considered to be within the scope of this invention and are covered by the following appended claims.

  An element, property, or action from one embodiment is easily recombined or substituted with one or more elements, characteristics, or actions from another embodiment, and includes a number of additional features within the scope of the present invention. Embodiments can be formed. Furthermore, elements illustrated or described in combination with other elements may exist as stand-alone elements in various embodiments. Therefore, the scope of the invention is not limited to the details of the described embodiments, but instead is limited only by the appended claims.

Claims (61)

A method for screening a patient for pudendal nerve therapy for treating urethral dysfunction in a patient comprising:
Introducing a catheter through the patient's urethra into the patient's bladder, the catheter comprising at least one electrode and at least one lumen;
Positioning at least one electrode on the catheter at a location in the urethra, delivering current to the pudendal nerve of the patient;
Delivering fluid through the catheter into the patient's bladder;
Delivering current through the at least one electrode to the pudendal nerve, the current comprising a low frequency current for contracting the patient's bladder and a high frequency current for opening the patient's urethral sphincter. Including at least one of the steps, and
Measuring information relating to a physiological response generated in response to the delivered current;
Utilizing information about the generated physiological response to assess the patient's response to the delivered current;
Including a method.   The method of claim 1, wherein the at least one electrode comprises first and second electrodes positioned to deliver current to the pudendal nerve.   The method of claim 2, wherein the first electrode delivers a low frequency current and the second electrode delivers the high frequency current.   4. The method of claim 3, wherein the catheter is positioned such that each of the first and second electrodes is positioned in the vicinity of the urethral sphincter.   The catheter includes at least two lumens, the first lumen fills the bladder, and the second lumen is delivered when the low frequency is delivered to contract the bladder. The method of claim 1, wherein the method is for excretion of fluid from the bladder.   The method of claim 1, wherein the bladder is filled to a target pressure.   The method of claim 1, wherein the target pressure is in the range of about 10-45 mmHg or about 10-20 mmHg.   The method of claim 1, wherein the bladder is filled to a target volume.   9. The method of claim 8, wherein the target volume is in the range of about 50-200 ml.   The method of claim 1, wherein the high and low frequency currents are delivered substantially simultaneously.   The method of claim 1, wherein the delivery of the high frequency current is initiated prior to delivery of the low frequency current.   The method of claim 1, wherein the low frequency current is in a range of about 15 Hz to 50 Hz.   The method of claim 1, wherein the high frequency current is in a range of about 4-10 kHz.   The catheter is positioned to block an opening in the patient's bladder such that when the bladder is deflated, excreted fluid flows substantially through a lumen within the catheter. The method described in 1.   The method of claim 14, further comprising measuring a flow rate of excreted fluid flowing through the catheter.   15. The method of claim 14, wherein the catheter includes an inflatable balloon or other means for blocking the patient's bladder opening.   The method of claim 1, wherein fluid flowing through the catheter from inside or outside the bladder does not substantially affect measurement of information about the generated physiological response.   The method of claim 17, wherein the unaffected information includes at least one of bladder pressure, urethral sphincter pressure, or urethral flow velocity.   The method of claim 17, wherein the lumen of the catheter has sufficient radial stiffness such that forces from fluid pressure within the catheter are not substantially transmitted outside the catheter.   The method of claim 1, wherein information about the generated physiological response is used to adjust characteristics of the high frequency or low frequency current.   21. The method of claim 20, wherein the characteristic is a frequency, magnitude, or waveform shape of the high frequency or low frequency current.   21. The method of claim 20, wherein the adjustment includes adjustment or fine adjustment of at least one of the high frequency or low frequency currents.   23. The method of claim 22, wherein the fine tuning includes adjusting the property by an amount less than about 5 percent.   23. The method of claim 22, wherein the adjustment includes adjusting the property in an amount in the range of about 5 to about 25 percent.   23. The method of claim 22, wherein the high frequency or low frequency current characteristic is used to enable or improve urethral function in the patient.   The method of claim 1, wherein the urethral dysfunction is a reduced ability to spontaneously control urination.   The method of claim 1, wherein the measured information is bladder pressure.   28. The method of claim 27, wherein the bladder pressure is measured using a pressure sensor.   28. The method of claim 27, wherein the measured information further includes contractile pressure of the urethral sphincter.   30. The method of claim 29, wherein the bladder pressure and the urethral sphincter contraction pressure are measured simultaneously.   30. The method of claim 28, wherein the bladder pressure sensor is positioned on the catheter or a distal end of the catheter.   30. The method of claim 28, wherein the catheter is advanced to position the pressure sensor inside the bladder.   The method of claim 1, wherein the measured information is contractile pressure of the urethral sphincter.   34. The method of claim 33, wherein the contraction pressure is measured using a pressure sensor.   35. The method of claim 34, wherein the pressure sensor is positioned adjacent to the urethral sphincter.   The method of claim 1, wherein the measured information includes urethral flow velocity.   38. The method of claim 36, wherein the high frequency or low frequency current characteristics are adjusted to achieve a target urethral flow rate.   38. The method of claim 37, wherein the characteristic is a frequency or magnitude of the high frequency or low frequency current.   38. The method of claim 37, wherein the target urethral flow rate is in the range of about 9-21 ml / min for male patients and 15-18 ml / min for female patients. A catheter for screening patients for pudendal nerve treatment,
A distal end, a proximal end, a catheter body for delivering fluid from the proximal end to the distal end and having a first lumen, the lumen having a distal opening A catheter body;
A first pressure sensor positioned on the catheter body near the distal end of the catheter body and measuring the patient bladder pressure;
A second pressure sensor positioned at a location proximal to the distal end of the catheter body and measuring the patient urethral sphincter pressure;
At least one electrode positioned on the catheter body at a location proximal to the distal end of the catheter and delivering current to the pudendal nerve;
With
The catheter body is advanced through the urethra of the patient and is configured to position the first pressure sensor and a distal opening of the lumen in the patient's bladder;
When the catheter is so positioned, the first lumen does not significantly affect the simultaneous measurement of the patient's bladder pressure or urethral sphincter pressure by the first or second pressure sensor, and the patient Configured to allow flow of the fluid into the bladder of
catheter.   41. The first lumen of claim 40, wherein the first lumen has sufficient radial stiffness or hoop strength to minimize force transmission from fluid pressure from the inside of the lumen to the outside of the catheter body. The catheter described.   42. The first lumen includes a reinforcing braid configured to minimize force transmission from fluid pressure from the inside of the lumen to the outside of the catheter body. catheter.   41. The catheter of claim 40, wherein the catheter body includes a second lumen for flow of the fluid from the bladder to the outside of the patient's body.   44. A catheter according to any of claims 40 or 43, wherein the radial stiffness of the first or second lumen is in the range of about 50-100 N / mm.   41. The catheter of claim 40, wherein the catheter is adapted to be positioned within a male urinary tract.   46. The catheter of claim 45, wherein the second sensor has a length of about 2 cm and is positioned about 2.5-3.5 cm from the distal end of the catheter.   41. The catheter of claim 40, wherein the catheter is adapted to be positioned within a female urinary tract.   48. The catheter of claim 47, wherein the second sensor has a length of about 1.5 cm and is positioned about 1.8-2.8 cm from the distal end of the catheter.   41. The catheter of claim 40, wherein the catheter body comprises elastomer, silicone, or polyurethane, PTFE, polyethylene, or PET.   41. The catheter of claim 40, wherein the at least one electrode comprises a pair of bipolar electrodes.   51. The catheter of claim 50, wherein the pair of bipolar electrodes are positioned at a distance selected to target the depth of current delivered in tissue to the pudendal nerve.   Further comprising at least a second electrode on the catheter body positioned at a location proximal to the distal end, wherein the first and second electrodes are configured to be connected to different current sources; 41. The catheter according to claim 40.   Each of the first and second electrodes and the second pressure sensor are positioned such that they can be in the urethral sphincter of the patient when the distal end of the catheter is in the patient's bladder. Item 53. The catheter according to Item 52.   41. The catheter of claim 40, further comprising a deployable anchor positioned on the catheter body, wherein the at least one electrode can be adjacent to the pudendal nerve when the anchor is deployed in the neck of the bladder.   55. The catheter of claim 54, wherein the deployable anchor is positioned near a distal end of the catheter body.   55. The catheter of claim 54, wherein the deployable anchor comprises an inflatable balloon. A system for screening a patient for pudendal nerve therapy for treating urethral dysfunction in a patient comprising:
A catheter according to claim 52;
Connectable to the first and second electrodes, a low frequency current for contracting the patient's bladder to the first electrode and a high frequency current for opening the patient's urethral sphincter A controller delivering to the second electrode;
A system comprising:   The controller further comprises a pressure display connectable to at least one of the first pressure or second pressure sensor and displaying at least one of bladder pressure or urethral sphincter contraction pressure. 58. The system of claim 57.   58. The system of claim 57, wherein the controller is further configured to deliver a sensory anomaly blocking current to prevent or reduce sensory anomalies resulting from low or high frequency currents.   60. The system of claim 59, wherein the catheter body includes a third electrode for delivery of the sensory abnormality blocking current.   60. The system of claim 59, wherein the sensory anomaly blocking current has a frequency in a range of about 3 kHz to 20 kHz.