JP2009522010A - Apparatus, system and related methods for delivering fluid to tissue - Google Patents

Abstract

  Devices and associated methods useful for dispensing fluid to the bladder, bladder neck, prostate, urethra, ureter, kidney tissue are described, the device comprising a steerable shaft, optical mechanism, lateral, longitudinal or remote Including one or a combination of features such as a plurality of fluid delivery orifices that may be movable or projectable to a tissue such as the bladder (including bladder neck), urethra, prostate, kidney, ureter, etc. Allows dispensing of one or more types of fluids.

Description

  The present invention relates to methods and devices for treating urinary tract tissue (eg, prostate tissue, kidney, ureter, urethral tissue, bladder, etc.), and devices, methods and surgical kits used in the treatment.

  The health status of the urinary tract is an increasingly important health problem, for example based on the elderly population. Treatment of urinary tract conditions is an area that requires significant research.

  Many methods and devices have been proposed for delivering therapeutic substances such as therapeutic fluids to the urinary tract, such as the kidney, ureter or lower urinary tract (urethra, prostate, bladder, bladder neck), etc. Each of these devices focuses on prostate treatment. Prostate disorder is a significant health risk for men. Prostate disorders include prostatitis, benign prostatic hyperplasia (BPH, also known as prostatic hypertrophy), prostate intraepithelial neoplasia (PIN), and prostate cancer.

  In addition to prostate conditions, other tissues in the urinary tract can be affected by medical conditions that can be treated by the provision of various therapeutic substances in fluid form. Bladder, ureters, kidneys, urethra, and prostate tissue (including the bladder neck) can be treated by the provision of drugs or other therapeutic agents.

  Various treatments of the bladder currently used or proposed, such as transurethral administration of an active pharmaceutical substance, are treated into the bladder using a single needle placed at the tip of a rigid shaft inserted through the urethra into the bladder. Involves sending fluids. Using a single needle at the tip of a rigid shaft to inject a therapeutic fluid, such as a drug, into the bladder can be a difficult procedure with various difficulties or undesirable effects. A rigid shaft with a single needle used for infusion into the bladder tissue places the needle at the desired single location or multiple locations for multiple fluid delivery, and the tip of the needle Must be operated, swiveled, turned, etc. to a predetermined position.

  The therapeutic agent should be given with the least possible discomfort and treatment time and with the best possible accuracy with respect to the location and dose. Thus, there is a continuing need to provide an excellent device for delivering therapeutic fluid to the lower urinary tract, kidneys, ureters, and the like.

(Summary of Invention)
The present invention includes a dispensing device for a multifunctional fluid (eg, a drug or other therapeutic agent). According to these devices, for example, in the urinary tract of men or women such as the bladder, bladder neck, kidney, ureter, urethra, prostate, etc. Local donation is possible. The device allows for the delivery of drugs at various tissue locations in the lower urinary tract, kidneys and ureters, and at multiple different tissue locations, using a single device. Devices and methods that provide infusion, infusion or instillation of pharmacological, chemical and biological agents are useful for the treatment of various urological conditions. The device can dispense a precise amount of fluid for injection or instillation at a precise location for superior treatment based on the precision and precision of fluid delivery.

  According to the above-mentioned multipurpose and versatile transurethral drug delivery device, drugs that can affect biological activity such as drugs, proteins, genes, chemical substances and cells are the bladder (referred to as “bladder” as used herein). Can be accurately delivered to one or more local regions of the lower urinary tract such as (including the bladder neck) or to the interior of the ureter, kidney, prostate, urethra, and the like.

  The device provides multiple different controllable depth tissue intrusions, multiple arcs, and multiple “throws” to dispense the same or different types of fluids. (Ie, the depth and location of the amount of fluid entering the target tissue). The device is designed in terms of one or more flexible or rigid shafts, etc. that allow for superior placement and accuracy of fluid delivery with respect to the location and amount of fluid delivery, superior comfort and safety of the patient. Features, selective fluid discharge function for discharging urine, function of maneuvering the tip of the device to improve the accuracy of the dispensing site, one of the tissue and extended dispensing orifices taken at the tip of the device One of optical features that allow user access to more than one scene, multiple fluid dispensing orifices, extendable fluid dispensing orifices, multiple fluid dispensing systems that allow dispensing of two or more different fluids It may include one or more or any combination of features depending on the requirements of patient comfort and therapeutic effectiveness.

  Advantages of the device include ease and accuracy of medication delivery by physicians, and a variety of male and female such as stenosis, urinary tract infection, BPH, prostatitis, overactive bladder, and inflammation and obstruction of the ureter It may be a tool for in-house treatment of urological conditions. Similarly, the device further makes the patient more comfortable and recoverable.

  The general features of the device according to one embodiment may include one or more of the following: superior comfort and utility compared to the utility of a flexible and rigid cystoscope or dispensing device, high dispensing efficiency, presence Chamber treatment capacity, multiple doses with large reservoir capacity, infusion, arc bend and “throw” (see definition of “throw” above), high flexibility, ie function across the urinary tract and bladder Sex, and the ability to deliver multiple types of different drugs or large amounts of the same or different drugs to different locations, for example.

  According to one embodiment, the device may be a substantially self-contained device including a shaft having a proximal end and a distal end, the device comprising a fluid delivery orifice at the distal end and a body at the proximal end. . The apparatus including the body includes an optical device coupled to the tip, a fluid reservoir in communication with the fluid delivery orifice, a pressure source in communication with the fluid reservoir, a light source for illumination use of the optical device, and a tip Related features such as actuators, triggers, etc. that activate features, including features such as base steering actuators that steer the tip, base triggers that move the orifice extension, or base triggers that cause fluid dispensing obtain. Optional embodiments may place a fluid reservoir and pressure source at the distal end of the device, proximal to the fluid delivery orifice. Still other alternative embodiments may place a pressure source, fluid reservoir, or both at a remote console or the like spaced from the proximal end of the device. The remote console can be coupled to the proximal end or body through a port in fluid communication with one or more fluid delivery channels at the proximal end or body of the device.

  An exemplary embodiment according to the present invention for supplying fluid to tissues such as the lower urinary tract, kidney, ureter, etc. includes a proximal end, a flexible shaft extending from the proximal end to the distal end, and a distal end of the shaft And a fluid delivery orifice extendable from the shaft. The fluid delivery orifice may be a needle or a needleless fluid delivery orifice.

  The device may include one or more needle or needleless fluid dispensing orifices, each protruding or extending and contracting independently from the shaft.

  The device in combination with any other features described herein includes a plurality of needleless dispensing orifices disposed along the length of the shaft, each dispensing orifice being an infusion or tissue to tissue The fluid can be released independently for instillation on the surface.

  A device in combination with any other features described herein includes a plurality of dispensing orifices disposed at a plurality of locations around the periphery of the shaft, each fluid dispensing orifice being associated with tissue. The fluid can be released independently for injection or instillation onto the tissue surface.

  The device in combination with any other features described herein includes a drain tube extending from the distal end to the proximal end, the drain tube being installed in the patient's body. Sometimes urine can be drained from the bladder.

  A device combined with any other features described herein may include a balloon or other positioning mechanism at the tip for placement within the bladder or bladder neck in use.

  The device in combination with any other features described herein may include one or more fluid reservoirs at the distal end, proximal end, along the length of the shaft, or any combination thereof. And a pressure source. A different orifice can be dispensed by connecting a dispense orifice to each of the plurality of fluid reservoirs.

  The device may include one or more needleless fluid dispensing orifices that protrude from the shaft device along the shaft or on the extreme end of the device, i.e., on the most distally disposed orifice extension.

  An exemplary device includes a body at a proximal end, a flexible (eg, steerable) shaft extending from the body to the distal end, and a plurality of fluid dispensing orifices at the distal end of the shaft that are in fluid communication with one or more fluid reservoirs. Including a combination of the features described above, such as a fluid dispensing orifice, one or more pressure sources in communication with one or more fluid reservoirs, wherein the fluid dispensing orifice extends along the length of the device or at the forefront of the device. It is disposed on an extendable member that extends and contracts from the shaft beyond.

  As used herein, the term “transurethral” in a transurethral fluid delivery method refers to passing or via a urethra by injecting a fluid delivery device through the interior space of the urethral lumen. Means the procedure to be performed, wherein the device may enter the urethral lumen via a meatus (male or female) or perineum, and the tip of the device extends through the length of the urethral lumen; Supply fluid to places such as the lower urinary tract, kidneys, and ureters.

  In one aspect, the invention relates to a device for delivering fluid to urinary tract tissue. The apparatus includes a proximal end, a flexible shaft extending from the proximal end to the distal end, and a fluid delivery orifice extendable from the shaft at the distal end of the shaft.

  In another aspect, the invention relates to a method of delivering fluid to urinary tract tissue. The method includes providing an apparatus as described herein, inserting the tip into the urethra, placing the fluid delivery orifice in place in the urinary tract, and extending the extensible fluid delivery orifice. Delivering fluid to the urinary tract through the expanded orifice.

  In another aspect, the invention relates to a device for delivering fluid to urinary tract tissue. The apparatus enables a proximal end, a shaft extending from the proximal end to the distal end and including a steerable portion, a fluid delivery orifice at the distal end of the shaft, and optical communication between the proximal end and the distal end. Including optical equipment. Another aspect relates to a method of dispensing fluid to urinary tract tissue by using the device embodiments described hereinabove. In the method, the tip of the shaft of the device is inserted into the urethra, a fluid delivery orifice is placed at a predetermined location in the urinary tract, the delivery location is observed using the optical device, and the tip of the shaft is steered. And providing fluid to the urinary tract.

  Another aspect of the invention relates to a device for delivering fluid to urinary tract tissue, which device can dispense two or more different fluids. The apparatus includes a proximal end, a shaft extending from the proximal end to a distal end, and a first group of two or more fluid dispensing orifices at the distal end, in fluid communication with each other and with a first fluid reservoir A first group of two or more fluid delivery orifices in fluid communication and a second group of two or more second fluid delivery orifices at the tip, wherein the second fluid reservoir and fluid are in fluid communication with each other A second group of two or more second fluid delivery orifices in communication with each other, a first cover for selectively opening and closing one or more first fluid delivery orifices, and one or more second fluid delivery orifices selectively. And a pressure source that pressurizes the fluid reservoir and can dispense fluid independently from each fluid dispensing orifice, for example. A related method is to prepare an apparatus as described herein and above, insert the tip of the shaft into the urethra, place a fluid delivery orifice at a predetermined location in the urinary tract, Providing a fluid.

(Detailed description of the invention)
The present invention is useful for supplying fluid (e.g., infusion or instillation) to the lower urinary tract such as prostate, kidney, ureter, urethral tissue, tissue of the bladder (including bladder neck) or the vicinity thereof. Related devices. The device releases a therapeutic “fluid” from the tip of an elongated shaft inserted into the urethra. The device may include a plurality of orifices for discharging fluid to a plurality of locations, fixed or movable relative to the shaft of the device. Embodiments of designs that include a plurality of orifices include extended, expanded, or extensible chains, strings, arrays, or sequences (eg, “daisy chains”). Each orifice is provided with a protruding mechanism ("orifice extension"), such as an extendable or fan-opening needle or needleless fluid delivery orifice ("orifice extension"), and a needle or a plurality for dispensing fluid around the interior of the bladder Can be placed on a balloon or the like containing a needleless injection or release mechanism.

  The present invention relates to devices, systems, and methods for dispensing (eg, releasing, injecting, or instilling) fluid to contact tissue, tissue, etc. in or near the lower urinary tract such as the bladder. The system is an undesirable or disadvantageous feature of systems and methods that use a single needle at the tip of a rigid shaft that has been used for transurethral fluid delivery of fluid into, for example, the bladder or bladder neck tissue. Can be overcome.

  Infusion can be performed by a needleless fluid dispensing system (eg, a needleless injector system, etc.), a needleless fluid dispensing system, or using a needle. The needleless injector system can include a fluid source that can be pressurized to allow the infusate (fluid) to penetrate into the tissue. Optionally, the fluid simply flows out of the orifice at a relatively low pressure from a needle or needleless fluid delivery system and is less invasive to the tissue, eg, by “dropping” of fluid onto the surface of the tissue. May be in contact with the surface.

  Apparatus embodiments include a plurality of fluid delivery orifices, such as in the form of needleless or needle type fluid delivery orifices arranged in any useful form. An exemplary plurality of fluid delivery orifices are all disposed at the tip, along the length of the device shaft, and extend outward from the shaft along the length of the shaft or at a desired location from the tip. Alternatively, multiple fluids that are spread outward and sequentially or simultaneously to specific locations in the anatomy of the urinary tract, such as at multiple locations around the urethra, bladder neck or bladder tissue ( The same or different fluids).

  According to an exemplary embodiment, the fluid delivery orifice may move in one or more dimensions relative to the long axis of the shaft. The fluid delivery orifice moves longitudinally in a direction along the longitudinal axis of the shaft, eg, along the longitudinal axis of the shaft, or "distant" from the end of the shaft or from "the most advanced or most advanced". Can do. In this exemplary embodiment, a fluid delivery orifice may project from the tip (or “leading edge”) of the shaft in the direction of the major axis including the tip. Alternatively or in combination, a fluid delivery orifice may be disposed from the shaft at a predetermined location along the length of the shaft, or at a location remote from the tip (“leading edge”) of the shaft. Can move away to the side. The fluid delivery orifice is a component of a movable orifice extension (e.g., mechanical paddle, needle, lumen, balloon, membrane, etc.), the component being positioned at a predetermined position along the length of the shaft. Can be stretched and shrunk from a predetermined position along or within the side of the shaft, or can be stretched from the tip ("leading edge") of the shaft.

  The features of the fluid dispensing orifice of the present invention are included as part of the present invention and can be included in the fluid dispensing device individually or in any desired combination. For example, embodiments of the present invention include a fluid delivery device that includes a positioning feature (such as a “positioning mechanism”), but the feature is proximate to the desired tissue by facilitating proper positioning of the fluid delivery device. Facilitates the positioning of a fluid delivery orifice (needle or needleless injector) for fluid delivery. The positioning features are various in nature and may include one or more of the following. Single or multiple balloons, multiple orifices, movable orifices located at the tip of the device to attach and secure the tip of the device, demarcation at a predetermined distance to the characteristic tip at the proximal end of the device , And optical features such as optical fibers used to position the endoscope. For example, the assignee's US Patent Application No. 11 / 186,218, filed July 21, 2005, published as US Patent Publication No. 2006/0129125 and co-pending under the name “Needleless Delivery System”. The entire disclosure of which is hereby incorporated by reference.

  Another embodiment of the fluid delivery device is one or more tissue tensioners that selectively apply pressure to contact the tissue at a desired location relative to the fluid delivery orifice, wherein the delivery of injection at the surface of the tissue is provided. One or more of the above features may be included, as well as a tissue tensioner that may optionally perform the tissue tension or tension desired. See, for example, assignee's US Patent Publication No. 2006-0129125, the entire contents of which are incorporated herein by reference, as an example of a tissue tensioner, an inflatable or expandable feature such as a balloon, or , Mechanically extensible features such as paddles, metal cages, other mechanically extensible structures or protrusions, vacuum, and the like.

  The fluid dispensing device as described is a method that allows direct observation of fluid injection or instillation, wherein the location of the fluid dispensing orifice is visually determined, and the location of the fluid dispensing orifice is indirect Can be used with a variety of dispensing methods, such as the so-called blind dispensing method.

  The direct observation method is an optical mechanism such as an optical fiber which is a type used with an endoscope apparatus, for example, using an optical mechanism included in a fluid dispensing apparatus as a component of the shaft, for example. With the use of optical features to observe automatically. The optical feature or optical mechanism can be generally any optical structure that can be installed within a shaft (eg, a flexible shaft, etc.) to allow observation from the proximal end to the distal location. Flexible fiber optic cables that are useful are known and commercially available, and can be made, for example, from glass or flexible polymeric materials that transmit light. Optionally and preferably, a light source may be positioned at or in optical communication with the tip.

  In one embodiment, a light bulb or other light source (light emitting diode) is placed at the distal end or proximal end and coupled to the distal end by a fiber optic cable, and a second optical fiber between the distal end and the proximal end Carries light backwards for observation at the proximal end. The viewing optical cable can be coupled to the lens or to an electronic image capture device such as a camera or computer. In a preferred embodiment, an electronic image sensor in the form of a miniature camera or electronic camera chip (eg, a charge coupled device or “CCD” chip) and a light source are mounted on the tip and electronically the base end. To provide an electronic image from the tip.

  A device that allows blind delivery is instead one or more non-optical features, such as the location of the device within the urethra, bladder, or bladder neck, particularly the location of the fluid delivery orifice. Since it includes non-optical features that allow an operator (such as a physician) to identify, fluid delivery for infusion or instillation can be performed at a desired location. The blind delivery technique is a segment landmark at the proximal end of the device, which refers to the distance to the feature location at the tip by using the segment landmark in combination with the known dimensions of the device and associated anatomy. Based on the characteristics of the device, such as a length measurement feature such as a segment mark, the delivery location can be identified. The segment landmarks can also be combined with the measurement of anatomical features such as the length of the prostate, urethra, bladder, bladder neck, etc. by known techniques such as using an ultrasonic location instrument. Blind dispensing techniques are also described herein, such as positioning features (eg, “positioning mechanisms” such as paddles, extensions, or balloons at the tip of the device), and movable fluid dispensing orifices. Other features of the device may also be included.

  Various embodiments of the fluid dispensing device of the present invention include a flexible shaft, a steerable shaft (referred to as a “flexible shaft”), a rigid shaft, assembled and disassembled prior to or following use. May include different types of shafts, such as multi-piece shafts of a designed design, integral shafts not designed to be assembled and disassembled prior to or following use, and combinations thereof. Certain devices and methods of the present invention include a shaft that is a flexible integral shaft that does not include an optical device such as an endoscope, but includes a positioning feature such as a balloon and together with a blind dispensing method. Used. Other devices and methods include a multi-component shaft that includes an endoscope and other features as described herein. Yet another embodiment includes an integral shaft that is steerable.

  A “steerable” shaft is semi-rigid and is also a “flexible” shaft that can be two-dimensional or three-dimensional at the tip of the shaft by manipulation of one or more steering actuators at the proximal end of the device. Refers to a shaft that can be controlled (ie, steered, articulated, deflected, or controllably bent). Steering mechanisms include various mechanical designs, one example allowing two-dimensional movement based on differential extrusion and pull-back (or tension and compression) of multiple cables within the shaft wall. Two or more of these mechanisms may be included in a single shaft to allow three-dimensional movement of the end of the shaft.

  Steerable shafts and mechanisms are known and understood in the field of endoscopes and other medical devices, and are designed to allow two-dimensional or three-dimensional movement, so that the distal tip or “leading edge” of the shaft Can be deflected in a desired amount, for example at least 45 °, such as at least 90 ° or at least 180 °, in a straight line toward the proximal end of the device. The radius of curvature of the bend produced during the most advanced deflection may be selected as desired and may depend on the overall design of the shaft and steering mechanism and the desired application of the device. According to one embodiment, the radius of curvature is 0.5 to 2 inches (e.g., 0.6 to 1 inch (about 1.524 to 2.54 cm)) of a portion of the tip shaft that is bladder It can be a radius of curvature that allows it to bend 180 ° backwards within.

  The length of the steerable portion can generally be as desired, for example, 0.5 to 1.8 inches (about 1.27 to 4.572 cm) or 2 inches at the end of the shaft, such as 0.6 to 1 inch. Typically, the steerable portion of the shaft can articulate in two dimensions, such as along a pivotal connection. According to one embodiment, the shaft may have two or more steerable portions, such as two portions that are each steerable in two dimensions that are mutually orthogonal planes. For example, 0.5-2 inches (e.g., 0.6-1 inch) at the end of the shaft can be steered in the first two dimensions, and adjacent 0.5-2 inches (e.g., 0.6-1 inch) of the shaft is second Steerable in two dimensions, optionally the second two dimensions may form a plane orthogonal to the plane formed by the first two dimensions.

  Examples of steering mechanisms include mechanisms that allow for the most advanced or partial steering (i.e. articulation, deflection, etc.) of the shaft by manipulating multiple deflection points hinged along the length of the shaft. . Manipulated by a plurality of control wires to bend or deflect the shaft in two dimensions. For example, U.S. Patent Publication No. 2006/00784383 with application number 10 / 955,930, U.S. Patent Publication No. 2006/0241564 with application number 11 / 398,890, U.S. Publication No. 09 / 969,927. See US Pat. No. 6,610,007, the entire contents of each of which are incorporated herein. As mentioned, one or more of the steering mechanisms may be included along one or more different parts of the length of the steerable shaft, and the steering of one or more shaft parts in two or more dimensions Is possible.

  Various embodiments of the present invention, alternatively or alternatively, add safety features that prevent accidental or inappropriate release of fluid from the device, features that add convenience or efficiency, such as a trigger mechanism. Systems and methods that allow multiple types of fluid delivery or multiple releases of different amounts of the same or different fluids, methods of controlling or programming infusion or instillation volume or depth of penetration, or single or multiple times Other features for fluid delivery may be included.

  Devices, systems, and methods are provided that enable infusion of therapeutic fluids. The device can be used in various applications related to diseases of the lower urinary tract or nearby tissues such as urethra, bladder, kidney, ureter, prostate. In certain embodiments, fluids such as pharmaceuticals or other active chemical agents or bioactive agents can be injected into tissue of the urethra, prostate, bladder, or bladder neck. The device can dispense therapeutic fluid (eg, infusion or instillation) to the desired tissue by placing one or more fluid delivery orifices at desired locations inside the lower urinary tract, kidneys, ureters, etc. Designed to be

  The present invention identifies and addresses practical problems associated with other modes of fluid delivery to tissues of the lower urinary tract. For example, injecting fluid into the bladder at the tip of a rigid shaft using a single needle may require a physician who is particularly dexterous and experienced due to the unwieldy nature of the rigid shaft with only one needle. . The fluid dispensing devices and methods described herein include selective flexibility of the shaft, the use of multiple needles or needleless fluid dispensing orifices, and multiple needles or fluid dispensing orifices as desired. Compared to the use of a single needle at the tip of a rigid shaft due to various reasons, such as the ability to place, move, protrude, open and close to inject fluid into the tissue or release fluid to instill fluid onto the tissue surface It is preferable.

  The apparatus and method include various features discussed herein, any of which can be used separately or in combination with any one or more of the other features. Exemplary features include the following. Device shaft configuration with multiple separable pieces or a single “integral” piece, rigid or flexible shaft, ability to move, project, open and close fluid dispensing orifices, multiple fluid dispensing systems (e.g., multiple fluid dispensing systems) Orifices and reservoirs), a number of fluid delivery orifices and positioning features, wherein the plurality of orifices and reservoirs are positioned at different positions along the length of the shaft of the apparatus or at different positions around the periphery of the shaft of the apparatus An extensible needle or a plurality of extensible needle-free fluid delivery orifices and a movable fluid delivery orifice, along the length of the shaft, around the periphery of the shaft, along the length of the shaft and at the periphery Can move around the part, or project far away from the end of the shaft or laterally or radially from the shaft Features such as movable fluid delivery orifices, eg positioning mechanisms such as balloons or other mechanisms that secure parts of the device within the urethra, bladder or bladder neck, etc., and accidental or inappropriate devices Safety features that prevent inadvertent activation or release of fluid from the device, and other features described herein.

  The apparatus of the present invention includes one or more fluid delivery orifices in fluid communication with one or more fluid reservoirs. The fluid reservoir contains a predetermined volume of fluid sufficient to allow one or more discharges of fluid from one or more fluid delivery orifices at the tip of the device. A tube hole may connect the fluid delivery orifice to the fluid reservoir and the tube hole may be positioned in the console at the proximal end or distal end of the device or spaced from the proximal end of the device. The one or more fluid delivery bores are spaced from the shaft and body, for example, at the distal end of the shaft, at a location at the proximal end of the shaft, at a body disposed at the proximal end of the shaft, or at a remote console A fluid delivery orifice may be coupled to a fluid reservoir located in any part of the device.

  One exemplary type of fluid dispensing device can generally include a body at a proximal end. The body may include a handle that allows a user to grip and operate the device, for example by inserting a device / shaft by operating the body. The body is also an activation feature, for example, maneuvering the steerable tip of the steerable shaft to activate fluid dispensing and moving the movable or projectable fluid dispensing orifice, selective port to move the body Can also include an activation feature that couples the remote console to the remote console, and optional optical features such as a lens that allows viewing through optical features (to observe the delivery site).

  The body may optionally include one or more fluid chambers (eg, a reservoir) and a mechanism that applies pressure to the fluid. A shaft is attached to the body. The fluid chamber may be a fluid reservoir, infuser or syringe chamber, or the device may include both at the proximal or distal end. A reservoir may refer to a fixed volume holding space for fluid, but is not necessarily pressurized to activate or release fluid from a needle or needleless fluid dispensing orifice, for example via a fluid dispensing bore. It is not necessary (although it may be possible) to be able to be under low, medium or high pressure. The pressure may be sufficient to allow fluid to enter the tissue or to enter the tissue surface without entering. The reservoir can be sized to contain a single or multiple doses of fluid and can be in the form of a removable or replaceable vial.

  Another type of exemplary injector chamber of a fluid chamber or reservoir is described. The chamber has a variable volume and is variable based on a plunger, piston, bellows or other mechanism that increases or decreases the volume (and pressure) of the chamber. The injector chamber allows the fluid contained in the injector chamber to be released from the injector chamber under pressure, for example by activating the device or instilling the fluid by discharging the fluid from a dispensing orifice. Pressure attached to the plunger, bellows or piston so as to contact the tissue surface of the tissue without entering the tissue and cover the tissue surface, or to release the fluid by pressure and inject the fluid by entering the tissue It can be pressurized by a source. The pressure source can be any energy source (eg, mechanical, electrical, etc.) such as a spring, solenoid, compressed air, manual injector, power, hydraulic, pneumatic source, etc.

  An exemplary fluid delivery device attached to the body may include an elongate shaft that is inserted into the urethra, for example, through the entrance, or through the perineal incision, preferably through the entrance. Preferably, the patient is treated on an outpatient basis due to the ability to place the device through a portal instead of an external incision. The use of a flexible shaft improves patient comfort.

  The device includes a distal end and a proximal end. The tip, including the shaft, will generally include the portion of the device that is positioned inside the patient's body during the therapeutic procedure. The tip is typically a functional feature that acts on the fluid or tissue during use and includes one or more fluid dispensing orifices, a dispensing head or extension that supports or houses one or more dispensing orifices ( "Orifice extension"), if used, access to one or more balloons or other forms of positioning device or positioning mechanism, selective discharge orifice connected to the discharge tube, needleless fluid delivery orifice This includes functional features such as a selective opening / closing mechanism and optical equipment. The tip may also include fluid delivery means such as a fluid reservoir, a pressurization mechanism, a fluid delivery tube hole connecting the fluid reservoir to the fluid delivery orifice, or any combination of two or more thereof.

  The orifice extension can be any structure that can be manipulated and controlled to move the fluid delivery orifice a predetermined distance from the shaft. An example is a mechanical paddle, which can be activated to expand away from the shaft and pulled back toward the shaft, and includes a fluid delivery orifice on the paddle itself at the movable end of the paddle; The other end of the paddle is installed on the shaft. Another example of an orifice extension is an extensible tube hole that extends and contracts from a predetermined location along the length of the shaft or from a predetermined location at the end of the shaft (the “leading edge”). Yet another example of an orifice extension includes one or more fluid delivery orifices in place on the balloon and a lumen (eg, an expandable lumen) connecting the fluid delivery orifice to a shaft. A balloon, fan or other membrane structure. The balloon, fan, or membrane is inflated, outwardly expanded, or deployed to move a fluid delivery orifice away from the shaft with the balloon, fan, or membrane.

  With respect to an orifice extension that includes or is in the form of an extensible lumen, an “extensible lumen” is a lumen that can be extended from a shaft. The extensible bore is a shaft in a direction that includes components longitudinally along the long axis of the shaft, in a direction that includes components laterally from the long axis of the shaft, or in a direction that includes components in both directions And move the orifice of the tube hole to a predetermined distance (ie, move the orifice away from the shaft).

  The extensible bore can be any bore that can dispense fluid as generally described herein, and is necessarily appropriate to allow the desired motion, mechanical properties, and fluid delivery. Dimension and structure and mechanical properties may be used. It is useful to combine reduced dimensions, desired flexibility and elasticity, and strength and ability to withstand large fluid pressures. Features such as tube hole material, wall thickness, and inner and outer diameters are combined to provide the desired strength and flexibility. The inner diameter is preferably large enough to reduce the pressure drop, and the desired wall thickness and material allows the desired pressure resistance and flexibility.

  The tube structure may exhibit a continuous inner diameter, outer diameter and wall thickness along the entire length of the tube hole. Optionally, the bore is dimensioned along the length of the bore (e.g., wall Thickness etc.) may vary. The exemplary dimensions for the bores described herein depend on the overall system design configuration and on whether the fluid is dispensed by infusion or by instillation, depending on pressure drop, strength and Any size suitable for the balance of properties including flexibility can be used. A predetermined balance is necessary, for example, because a relatively small inner diameter increases pressure drop and a thin perforated wall can increase flexibility but decrease strength. For devices that include a remote console (see below), for fluid injection (compared to instillation), examples of internal diameters may be greater than 0.020 inches, such as 0.022 to 0.030 inches (polyethers below). An exemplary outer diameter for the same exemplary bore may be at least 0.032 inches, for example 0.034-0.045 inches (1 inch = about 2.54 cm), for a bore made with ether ketone or “PEEK”.

  A tube hole is any material that is flexible, elastic and strong as appropriate, and can be a metal (e.g., nitinol, stainless steel, or other metal useful in medical devices), metal reinforced polymers, polymer composites, or polymers Can be made of material. Typical bores are high-strength polymers such as polyimide, polyetherimide available from General Electric under the trade name Ultem®, and PEEK® (polyethylene) available from Victrex plc. It can be made of linear aromatic polymers such as ether ether ketone). In some embodiments, the non-metallic polymer pores can be reinforced by including materials such as nanoparticles, clay or glass. In some embodiments currently contemplated, the non-metallic polymer bore can be reinforced with one or more polymers, carbon, graphite or glass fibers, such as tubing braided with Kevlar or other high strength polymers, for example. . See, for example, US Provisional Patent Application No. 60 / 866,741, filed November 21, 2006 by Crank and referred to as “Injection Tube for Injection Injection Device,” the entire contents of which are hereby incorporated by reference. Incorporated in the book.

  The bore may be fabricated to have a burst strength of at least greater than about 2,000 pounds per square inch (psi), and in one embodiment in the range of about 2,000 psi to about 5,000 psi. The lumen is made to have expansion properties, in which case the orifice or injection port located at the tip of the lumen is not swelled, which adversely affects the fluid ejection used to dispense the treatment fluid. Preserve shape and dimensions.

  The proximal end of the exemplary fluid delivery device may include a body that remains external to the patient when in use. The proximal end may include a structure (eg, a handle or other type of gripper) that allows handling of the device, such as manipulating the shaft, during use of the device. The proximal end may also include other features that need not be internal or cannot be internal during a therapeutic procedure. Examples of features such as a body that may be part of the proximal end include a fluid source and a pressure source for that fluid, an eyepiece of the type used with an endoscope if included in the device, or other optics Mechanical features, power supplies, pressure sources, fluid sources or vacuum sources, such as mechanical features, tube holes, tube extensions, fluid delivery means, or triggers or handles to hold or activate other features at the tip Such as, an adapter for attaching a base end to an accessory device, a discharge port connected to a discharge pipe hole, and the like.

  The body may also optionally or additionally include one or more for attaching the body to an external and optionally remote component such as an external or remote pressure source, a vacuum source or an external or remote fluid reservoir. An attachment port may also be included. For example, the body may have a fluid port that is remotely attached to a console that includes a fluid source. The console may include a fluid reservoir and a pressure source that pressurizes fluid from the console through the body, through a fluid delivery tube hole in the shaft, and then through the fluid delivery orifice.

  The shaft of the fluid delivery device may be an elongate component, the elongate component generally extending from the proximal end to the distal end, and the elongate component by use and manipulation of the proximal end or other external features. Includes features and components that allow the use and manipulation of tip features. The shaft is generally configured in various configurations as desired, e.g., can be an integral configuration that is not designed to be assembled and disassembled prior to use, at the time of use, or after use, or used in surgical procedures. A multi-piece configuration comprising a plurality of elongate shaft components or elements that fit together as a whole to be assembled can be a multi-piece configuration that is assembled and disassembled before and after use as desired. See, for example, U.S. Patent Publication No. 2006/0129125, which describes different types of shafts that are flexible, rigid, unitary or composed of multiple pieces.

  Any multi-component or monolithic shaft may be flexible, steerable or rigid, and any such type of shaft may be any of the features of the device described herein. Features can be included.

  Metallic or polymeric materials may be useful for any type of shaft or for any type of shaft component. Materials that may be particularly useful for rigid multi-piece shafts include rigid polymer materials such as rigid plastics or rigid metal materials or rigid ceramic materials or composite materials. Specific examples include nitinol, polycarbonate, stainless steel, ABS, polyimide, polyetherimide, nylon, PEEK and the like.

  Materials useful for flexible shafts, or multi-shaft shaft flexible components, include polymeric materials known to be useful for catheter devices such as urinary catheters (eg, Foley catheters, etc.) Of a relatively flexible polymer material. Specific examples of the flexible polymer material include silicone, polyurethane, block copolymers such as polyether block amide, rubber, latex and the like.

  Materials that may be useful for steerable shafts include some of the same materials listed above for flexible shafts, such as metals or rigid polymers (e.g. hinges), stiffeners for supports or outer layers Or a flexible polymer, a metal reinforcement | strengthening polymer, etc. are contained.

  A single component or “integral” shaft for a fluid dispensing device is a shaft that is substantially or fully assembled at the time of device manufacture, so that it can be assembled or disassembled prior to or after use. Not designed. The shaft is flexible, steerable or rigid and can be made of a metal or polymer material or a combination of such materials. A flexible integral shaft is a flexible elongate component that extends from the proximal end to the distal end of the fluid dispensing device and is open to one or more needles or needleless fluid dispensing orifices or such orifices. Forms or includes the necessary functional elements such as holes, tube holes, triggers, activation mechanisms, steering mechanisms, hinges for steerable shafts, optics, etc., and features at the tip are manipulated from the proximal or remotely. These features of the integral shaft can be a substantially permanent feature of the device that is not designed to be removed from the shaft or disassembled into multiple components of the shaft.

  According to one embodiment, the integral shaft is a flexible shaft made from a flexible polymer, such as a tube hole (e.g., fluid supply tube, discharge tube, expansion tube, etc.), activation mechanism, It may include optical equipment such as optical fibers, and any other necessary mechanical features that couple the tip features or mechanisms to the proximal end of the device. Each of the tube holes may be a shaft or a flexible tube hole formed by or embedded in an inner wall or outer wall or surface of the shaft.

  If necessary, the bore is strong enough to withstand the operating pressure, as in the case of a fluid delivery bore connecting the fluid delivery orifice at the distal end to a pressurized source of fluid at the proximal end. An exemplary high pressure (“injection pressure”) can be 2000 pounds per square inch or more. The fluid delivery bore is a flexible material (e.g., metal or polymer tubing) that can withstand such injection pressure, e.g., nitinol, stainless steel, reinforced polymer (e.g., as described elsewhere herein). Braided).

  The fluid delivery tube hole may also be configured and assembled to allow movement of the fluid delivery orifice as described herein. As an example, the fluid delivery tube hole moves longitudinally along the length of the shaft, and the fluid delivery tube hole can extend in the distal direction and optionally, for example, laterally from the tip of the shaft. Optionally or additionally, the fluid delivery tube bores away from the shaft at a predetermined position along the length of the shaft and away from the side of the shaft to bend or deflect a fluid delivery orifice extension that moves relative to the shaft. This allows lateral movement of the fluid delivery orifice away from the long axis of the shaft.

  The activation mechanism extends the needle (or other fluid delivery orifice extension) as desired, activates the injector or pressure source at the tip, moves the fluid delivery orifice or orifice extension, including the fluid delivery orifice, Includes or is in a form that includes mechanical or electronic features or connections such as wires, hinges, levers, or other connections or mechanical devices used to operate the device between the proximal and distal ends Can be done. Other examples of activation mechanisms at the proximal end include a plunger or other useful for instilling or injecting tissue into a needle or needleless fluid dispensing orifice through pressure through a fluid dispensing tube hole. The actuator of this is mentioned.

  The term “flexible shaft” refers to a sufficiently flexible shaft that is bent and bent to allow the shaft to be inserted into the urethra through a mouth or external incision, and Allows a portion of the shaft tip to be guided into the urethra, and optionally into the bladder neck or bladder, as can be done with a Foley catheter. The flexible shaft may be sufficiently soft and flexible to fit or partially fit the patient's anatomy, as in a Foley catheter. In contrast, a “rigid” shaft is substantially rigid and is used in a multi-piece construction, allowing tip control by manipulation of the proximal end in use. The rigid shaft may typically be a metal or similar rigid type shaft used with, for example, a rigid endoscope or laparoscopic surgical device. The “steerable” shaft is non-rigid and flexible, and for the purposes of description, the steerable shaft is considered “flexible”, but because of the configuration including the steering mechanism, a typical Foley catheter shaft May be slightly less flexible. A “steerable” shaft may be of the type used for steerable endoscopes or other steerable medical devices.

  Integral shafts for steerable or flexible devices, shafts, etc. are similar materials and methods used in the fabrication of known urinary catheter devices such as Foley catheters, steerable endoscopic devices, etc. The device can be configured to include one or more fluid delivery orifices (e.g., needle or needleless fluid delivery orifices) and optionally other features as described herein. . The integral shaft can include any one or more of the following. One or more fluid dispensing orifices (e.g., flexible), a movable fluid dispensing orifice that moves along the length or circumference of the shaft, and a protrusion of the fluid dispensing orifice laterally or longitudinally away from the shaft Enabling orifice extensions (e.g. paddles, mechanical extensions, balloons, needles, or expandable lumens, etc.), tissue tensioners, balloon positioning devices, optical fibers such as flexible fiber optic cables Features, a port or other opening and closing mechanism that selectively exposes a needleless fluid dispensing orifice to allow fluid discharge (injection or instillation) from any one or more of the plurality of fluid dispensing orifices One or more fluid extension orifices (i.e., parallel or series orifices) each containing one or more bore extensions, separately from the shaft, or An array of tube hole extensions that can be extended together. Any one or more of these features may be placed along the desired length of the device, at a predetermined location at the tip of the device, or along an integral shaft, and functional at the proximal end by a borehole or activation mechanism. Can be linked to.

  The integral shaft is particularly useful for devices that include a flexible shaft and that include a device positioning mechanism such as one or more balloons at the tip to position the device in use. Since the use of the device positioning mechanism can advantageously eliminate the need for optical features such as an endoscope, fluid delivery can be performed by blind viewing methods. (Still other embodiments of the device include a flexible shaft (e.g., steerable) in combination with optical features.) Certain devices of the present invention have an integral flexible shaft, multiple times from the tip of the device. A plurality of needles or needleless fluid dispensing orifices that are selectively movable along the length or circumference of the shaft or extendable from the shaft, allowing the dispensing of a plurality of different fluids Multiple fluid delivery systems, and one or more inflatable balloons at the tip, and a drain orifice at the distal end, and a drain tube opening from the bladder (when installed) to the proximal end of the device, such as a urethral catheter Other features may be included. Such a device comprising a flexible shaft, a drainage hole for draining urine from the bladder (eg, as a Foley catheter does), and a selective balloon may be referred to herein as a “fluid delivery catheter” configuration. In use, the “fluid delivery catheter” configuration is external to the urethra, as with a Foley catheter, as opposed to being inserted into the urethra via an external incision and tissue passage as in a fluid delivery device with a rigid shaft. It can be inserted through an orifice.

  The integral shaft is also a device that includes a flexible steerable shaft, allowing the user to observe the fluid dispensing site and to steer the tip or cutting edge of the device at the dispensing site as desired, It can be particularly useful for devices that include an optical mechanism (including a light that illuminates the dispensing site) that allows precise placement of fluid dispensing. Certain devices of the present invention include an integral steerable shaft, one or more needles or needleless fluid dispensing that provides multiple fluid dispensing (same or multiple different types of fluid) from the tip of the device. Each fluid delivery orifice is selectively and preferably movable along the length or periphery of the device, or can be extended longitudinally, distally or laterally away from the shaft. possible. The device may optionally include other features of the urinary catheter, such as an exit orifice at the tip and an exit lumen leading from the bladder (when installed) to the proximal end of the device. In use, these device configurations, including steerable shafts, drain tube holes and optical features, are inferior to being inserted into the urethra through external incisions and tissue passages in rigid shaft fluid delivery devices. It can be inserted through the external orifice of the urethra as well as with a catheter.

  In contrast to a unitary shaft, a shaft referred to as a “multi-component” shaft is two or more elongated member pieces or components that fit together as an assembled whole prior to or use. It may include two or more elongated member pieces or components that can be later disassembled. Typical components of a multi-component shaft are an outer shaft or “sheath” in the form of an elongate rigid hollow sheath and a unitary assembly with the outer shaft to form a functional assembled multi-component shaft. One or more additional inner shaft components obtained.

  The outer shaft or “sheath” of the multi-component shaft can be a basic sheath that is sized and shaped to include one or more inner shaft components and rest within the urethra. The sheath component of the multi-piece shaft may include only a hollow, rigid sheath, or a plurality of needles or needle-free fluid delivery orifices, one or more tissue tensioners, fluid delivery tube holes or delivery heads, one A positioning component such as the balloon described above, and a hollow, rigid sheath having the functional features of the device, such as one or more lumens that connect the functional features at the distal end of the sheath to the proximal end. The exemplary outer shaft can be a rigid sleeve (eg, made of metal or rigid plastic) that can be inserted into the patient's body through the urethra or through an external incision in the perineal area. When inserted, one or more inner shaft components may be inserted into the outer shaft as desired.

  The inner shaft component of the multi-component shaft can be fitted within the outer shaft component or sheath, and has a needle or needleless fluid dispensing orifice, one or more lumens, one or more dispensing heads, or lenses One or more functional features of the device, such as optical features such as open viewing channels, tissue tensioners, and the like. An inner shaft that includes a needle or needleless fluid delivery orifice is specifically referred to as, for example, an inner “fluid shaft” and is connected to the proximal end of the inner shaft component via one or more fluid delivery tube holes. One or more needles or needle-free fluid delivery orifices. Optionally, the inner shaft component (or a feature of said component such as a needle, fluid dispensing orifice or dispensing head) is generally outside for any reason, such as allowing movement of the dispensing head or fluid dispensing orifice in use. It is movable within the shaft component or shaft.

  Similarly, optionally, embodiments of the present invention may combine multiple device features into a single rigid shaft component. For example, the rigid shaft component can be sized and shaped to combine an outer sheath with an inner fluid shaft and receive an endoscope. Optionally, the rigid shaft component can be sized and shaped to receive an inner “fluid shaft” that combines an outer rigid sheath with an endoscope and accommodates a fluid delivery bore and a fluid delivery orifice. As yet another alternative, the endoscope can also combine outer shaft components and injection features into a single rigid shaft that is not designed to be assembled and disassembled.

  In general, any of a variety of shaft designs can be used together for either blind or direct observation methods. The optical features can be obtained using known materials and configurations, along with any form of optical features of fiber optic devices or other optical devices known to be useful for endoscopic devices, etc. It can be incorporated into any of the integral shaft, rigid shaft, steerable shaft or flexible shaft. An eyepiece may be placed at the proximal end of the device, and one or more open viewing channels, optical fibers, lenses, multiple lenses, mirrors, refractive or reflective devices, or combinations thereof may be used, Visual communication between locations at the tip can be formed. For example, with respect to a flexible shaft (such as being steerable), the flexible optical fiber may extend in place along the shaft from the eyepiece at the proximal end of the device to the distal end of the device. The optical fiber enables observation of the tip of the shaft, for example, at a location where the fluid delivery orifice is observed.

  According to direct observation methods, optical features such as optical fibers are optionally combined with the tip of the steerable shaft to observe internal tissues such as the internal urethra, bladder, bladder neck, ureter or kidney. Used, direct observation methods may facilitate precise placement of a fluid delivery orifice or multiple fluid delivery orifices within, for example, the prostate sac, bladder neck, bladder, ureter, kidney, etc. as desired.

  On the other hand, blind viewing methods can eliminate the need for optical features and instead rely on the positioning of the injection needle or needleless fluid delivery orifice by using other features such as the known dimensions of the device. , Or features of the distal end of the device, such as one or more distal balloons, or proximal balloons, or other positioning mechanisms that together allow blind fluid delivery to the desired tissue location, distance segment landmarks at the proximal end of the device, tissue tension May depend on positioning the movable orifice.

  Any combination of shaft characteristics (such as a rigid or flexible shaft (such as steerable)) and other features described herein may be useful in the fluid delivery device as desired. Several special features or combinations of features may be particularly useful for either rigid or flexible shaft designs. Rigid multi-component shafts or steerable integral shafts are particularly useful when combined with direct observation features and selectively use other types of positioning features such as one or more balloons at the tip of the device. Can be eliminated.

  Certain integral flexible shaft embodiments of the device are useful because they include a flexible shaft, which provides patient comfort and the need for an external incision to access the urethra. Injection (as commonly used with rigid shaft designs) and movable or extendable needles or needle-free fluid delivery orifices projecting laterally or distally from the shaft, or injection at the tip of the device It has the advantage that a blind viewing fluid dispensing method based on the use of positioning features such as balloons can be used selectively. A flexible shaft device may be configured to place one or more needles or needle-free fluid delivery orifices (ie, “positioning features” or “ It may include a flexible shaft that includes a focusing feature ")". Preferably, the flexible shaft does not require an external incision or a tissue passage from the external incision to the urethra (e.g., the insertion method used for Foley catheters) via an external urethral orifice (oral entrance). Can be inserted. Using positioning features may avoid the need for optical components to position the tip (although other flexible shaft configurations may suitably include optical features for direct viewing). Exemplary non-optical positioning features are observable distance segment landmarks at the proximal end, such as a tip, a fluid delivery orifice, or a feature (such as a balloon or other feature) that is positioned relative to the bladder or bladder neck or bladder. Distance segment markers used to measure location, known dimensions of the device, one or more balloons, needle or needleless fluid delivery orifice that protrudes from the shaft into the bladder to allow desired placement in the bladder , Or other positioning features at the tip of the shaft. Also, multiple or movable features such as multiple or movable (eg, projectable) fluid delivery orifices are useful to avoid the need for optical features. The plurality of fluid dispensing orifices can be disposed at a plurality of locations along the longitudinal or peripheral edge of the tip of the device and dispense fluid to any location within the plurality of locations of the needle or needleless fluid dispensing orifice Can be used independently. The movable needle or needleless fluid dispensing orifice allows movement of the needle or needleless fluid dispensing orifice along the length or periphery of the device after the device is secured to some extent inside. Optionally, the projectable fluid delivery orifice projects distally from the tip or tip of the device shaft, projects laterally along the shaft, or either laterally and proximally or distally along the shaft. It can project in one direction (longitudinal direction).

  In accordance with an embodiment of the apparatus of the present invention, a plurality of needles or needle-free fluid dispensing orifices (collectively “fluid dispensing orifices”) are single or multiple locations along the shaft that are For example, the tip of the device is positioned where the needle or needleless fluid delivery orifice is placed at a desired location in the patient's body, such as in the bladder (including the bladder neck) or elsewhere in the lower urinary tract. The needle or needle-free fluid dispensing orifice is a fluid source (s) that can be pressurized to inject fluid into the tissue or release fluid from the fluid dispensing orifice to instill or coat the surface of the internal tissue. One or more fluid sources to the orifice of the fluid (eg, via a fluid delivery tube hole). The plurality of orifices may move integrally or separately along the length of the device, distally or laterally, as described. Each of the needle or needleless fluid dispensing orifices is connected to a mechanism at the proximal end of the device to allow movement or protrusion of the orifices, and the plurality of orifices can be moved or protruded together or independently. Each orifice is also in fluid communication with a fluid supply source (e.g., at the proximal or distal end of the device) and an activation mechanism at the proximal end to allow for the release of fluid from the orifice and separate the fluid from each orifice. Or to release together.

  The fluid delivery orifice can be any size (e.g., length and diameter) useful to produce the desired properties of the injection, such as the desired injection speed, fluid volume, fluid dispersion (e.g., size and shape of the population of injected particles). Can have. Examples of useful orifice diameters include factors such as whether fluid is injected to enter the tissue or instilled into contact with the tissue surface, and if injected, the injection parameters and the tissue to be injected Depending on the type and dimensions (eg depth), it can be in the range of about 0.001 to 0.05 inches. The fluid delivery orifice may be larger or smaller than the fluid delivery orifice near the fluid delivery orifice, if desired, and may affect the fluid ejection speed at the fluid delivery orifice. Examples of useful orifice shapes include features such as venturi, continuous uniform diameter along the length of the orifice, funnel shape, and the like. In many cases, a relatively small diameter orifice may produce an injection depth that penetrates relatively deeply into the tissue (with the same injection pressure) compared to a large diameter orifice. In general, the size and shape of the injection orifice can be selected for a particular drug delivery operation (infusion, instillation, etc.) and tissue characteristics.

  The pressure source that pressurizes the fluid for discharge from the fluid delivery orifice can be mechanical (such as a spring or solenoid), pneumatic, pressurized gas such as carbon dioxide, hydraulic, electrical, as will be understood, It can be located along the proximal end, distal end of the shaft, or along the shaft. The pressure source can be controlled mechanically or electronically. The pressure source is a transient pressure at a fluid delivery orifice that allows fluid contained in a fluid reservoir (e.g., a fixed volume or variable volume chamber) with sufficient force to cover or enter the tissue. The supply orifice can be pressurized to a transient pressure high enough to produce the desired amount of fluid flow.

  As an additional optional feature of the fluid dispensing device of the present invention that is selectively used in combination with other features described herein, for example, a “positioning feature” disposed at the tip of the device shaft An inflatable balloon may be mentioned. The fluid dispensing device may include one or more balloons at the tip to allow the device to be mounted and secured in a desired position during use. The balloon that positions the fluid delivery device is particularly useful in combination with a device that does not include any optical features such as an endoscope that directly observes the manipulation of the tip features such as the fluid delivery orifice of the device. Placing the balloon at the tip of the device at a known distance from the fluid delivery orifice facilitates proper placement of the fluid delivery orifice on the bladder neck or the like based on the positioning of the balloon.

  An example of a balloon that allows a physician to position the fluid delivery device if desired is a balloon that can be placed in the bladder or bladder neck when the device is installed. The balloon may be of the type used in Foley catheters, but may be configured to function as described herein at the end of a fluid delivery device rigid or flexible shaft. The balloon secures the overall location of the device in use, i.e., places the device shaft in the desired location, and positions one or more fluid delivery orifices as desired, for example, in the bladder or bladder neck. It is useful in. The balloon may be positioned on the shaft in the distal or proximal direction of the fluid delivery orifice. When the device is installed, the balloon is in the bladder or bladder neck, properly positioning the device during treatment, and sealing the bladder neck or bladder neck from the bladder.

  Another feature of the fluid delivery device used in selective combination with other features described herein is a tissue tensioner that is placed at the tip of the device. The tissue tensioner can be placed on the shaft, for example, in the urethra or bladder, somewhat near the fluid delivery orifice and near the fluid delivery orifice when the device is installed. A tissue tensioner is a mechanism that can contact tissue, such as urethra or bladder tissue, holding a desired portion of tissue in place with respect to a fluid delivery orifice and allowing fluid to enter the tissue upon injection. It can be a mechanism that selectively applies tension or stress on the tissue so that it can affect the way it is dispersed within. The tissue tensioner can be used in combination with any of the other features described herein, such as the rigid shaft configuration of the device, while the tissue tensioner is used with a device that includes a flexible shaft. It is particularly useful when The tissue tensioner can facilitate good results when injecting fluid through the tissue of the lower urinary tract by ensuring that the tissue is fixed and has the desired amount of tension to receive the injection.

  Examples of tissue tensioner types include inflatable balloons placed on the shaft in the vicinity of the fluid delivery orifice and mechanically expandable or retractable components such as paddles, protrusions, levers, metal cages. Any of them may extend from the shaft of the fluid delivery device to apply pressure on the internal tissue, such as on the urethral tissue in the bladder or bladder neck, for example. The tissue tensioner is described in the assignee's co-pending US patent application Ser. No. 11 / 186,218, filed Jul. 21, 2005, and referred to as the “needleless dispensing system”, the entire disclosure of which is incorporated herein by reference. The contents are incorporated herein by reference.

  Another example of an optional feature that can be used with any of the devices identified herein is filed on Nov. 9, 2006 by Crank et al. “Mechanical Volume Control for Injection Devices”. The assignee's US Provisional Application No. 60 / 856,035, referred to as the “Law”, is hereby incorporated by reference in its entirety. The adjustable volume control feature allows for adjustable control of fluid delivery when the feature is included in the device described herein. The adjustable volume control method generally includes a mechanical stop system comprising a plunger member and a stop member, wherein the plunger member and stop member physically interact to limit the insertion length of the plunger, Simultaneously control the amount of treatment fluid drained by the plunger. In one embodiment, the stop member is configured to be activated coaxially with the plunger motion, while in other embodiments the stop member may be activated in a direction that intersects the plunger motion. An exemplary design for a mechanical stop system is shown in FIGS.

  The device may include a positioning mechanism or a positioning mechanism that allows the user to place the tip at a desired location in the lower urinary tract. Examples include balloons, paddles, or other devices placed at the tip of the device that stretch or expand to allow the structure to contact the bladder neck when the structure is placed in the bladder. It can be an extension or an extensible feature. In use, the positioning mechanism contracts into or against the shaft during insertion of the device tip into the urethra, bladder and bladder neck. Once the tip is inserted and the positioning mechanism is placed in the bladder or bladder neck, the positioning mechanism expands away from the shaft and the device (including the shaft and positioning mechanism) is moved proximally by the operator. (E.g., pulled). When the positioning mechanism is pulled in the proximal direction, the positioning mechanism contacts the bladder neck, and the operator senses this resistance in the bladder neck, and the positioning mechanism is in contact with the bladder neck and is at a desired location. Recognize that.

  The device of the present invention optionally includes a plurality of fluid delivery orifices at the tip, some or all of which may be projectable or disabled. Each fluid delivery orifice can be activated independently for fluid movement or discharge. The multiple fluid delivery orifice embodiments communicate with each other and with a common fluid supply. In other embodiments, two or more fluid dispensing orifices are each in communication with separate fluid sources to allow dispensing of different types of fluids at the tip of the device, i.e., a single device is a multiple fluid dispensing system. (Eg, a single fluid dispensing system may include one fluid dispensing orifice in communication with one fluid dispensing reservoir). Multiple fluid dispensing systems allow for the dispensing of two or more different fluids from the tip of a single device. Each fluid may be different or identical and may be dispensed using the same or different parameters such as dosage, dispensing pressure, dispensing for injection, dispensing for instillation, dispensing to different tissues, etc. As an example, the device provides two different drugs to the tissue of the urinary tract, optionally one drug can be applied to the surface of the tissue and the other can be applied (ie, injected) inside the tissue. Optionally, two different fluids can be dispensed, for example, at two different locations of tissue around the circumference of the ureter, or at different locations along the length of the urethra. Two or more fluids can be dispensed at the same pressure, different pressures, the same dosage, different dosages, and the like.

  Multiple types of different fluid dispenses are, for example, multiple fluid reservoirs that can independently contain fluid supplies for dispensing, each of which can dispense different fluids through different fluid dispensing orifices. Devices including two or more fluid reservoirs such as fluid reservoirs may be included. One or more reservoirs may be located at the tip of the device, the proximal end of the device, a remote console, or any combination of the tip, proximal or remote console.

  As used herein, a tip fluid reservoir has a predetermined volume at the tip of the device shaft and can contain more fluid than is required for a typical fluid delivery tube bore. An example of the volume of the tip fluid reservoir may be a volume that is comparable to the amount of fluid injection. A tip fluid reservoir is typically not required, but is preferred to improve fluid movement. For example, a tip fluid reservoir contains a predetermined amount of fluid at the tip of the device in the proximal direction of the dispensing orifice, reducing the need for fluid movement along the length of the device during infusion or discharge. Reduction of the amount of fluid movement can result in more efficient fluid delivery.

  FIG. 1 shows an embodiment of a device according to the invention, ie a fluid delivery device capable of blindly delivering fluid to the bladder or bladder neck. The apparatus 10 generally includes a distal end 12, a proximal end 20 with a pressure source (injector or syringe) 24 attached to a body 22, and a shaft 14. Shaft 14 includes a movable fluid delivery tube 16 that connects fluid reservoir 18 of injector 24 at proximal end 20 to needle 30 and fluid delivery orifice 32. Needle 30 and movable fluid reservoir 40 are placed in the bladder represented by bladder tissue 44 when device 10 is installed. As illustrated in this preferred embodiment, a single fluid delivery tube (16) has a single proximal fluid reservoir (18), a single distal fluid reservoir (40) and a plurality of fluid delivery orifices (32). , A single type of fluid (45) can be dispensed at the tip 12 from multiple fluid orifices.

  The discharge orifice 42 allows discharge of urine from the bladder in use and is connected to the proximal end 20 via a discharge tube hole (not shown) in the shaft 14. For example, the drain tube hole is positioned inside the shaft 16 and selectively penetrates the channel 41 of the tip fluid reservoir 40.

  The device 10 includes a tip 12 that includes a plurality of dispensing orifices 32 located at the end of an expandable needle 30. The extensible needle 30 is moved by the integral movement of the fluid delivery tube bore 16, movable fluid reservoir 40, and needle 30 as an assembly of the shaft 16 (e.g., through an aperture in the shaft 14). 1 and moving in the direction of the arrow at the tip 12 of FIG. 1) can be expanded and contracted from the shaft 14 (longitudinal movement is indicated by the arrow on the body 22 of FIG. 1 and the arrow of FIG. 1A). Movement of the needle 30, reservoir 40 and tube 16 assembly can be accomplished by movement of a mechanism incorporated within the body 22. As shown in FIG. 1, the mechanism is a simple sliding chamber 48 that connects the injector 24 to the fluid delivery tube hole 16, with the movement of the slidable handle 50 opening channel 49 ( It includes a sliding chamber 48 that moves relative to the shaft 14 within (shown in phantom). The slidable chamber 48 can be moved with the injector 24 relative to the body 22 and the shaft 14.

  The expandable needle 30 can be placed in a retracted position and the tip 12 can be inserted into the patient's body transurethrally through the mouth and placed in the bladder, for example, near the bladder neck. A selective balloon (not shown) at the tip can be inflated inside the bladder. Once installed, the needle 30 can extend from the shaft and extend laterally and proximally (toward the proximal end of the device 10) to contact the bladder neck or bladder tissue 44. Each of the expandable needles 30 can be connected to one or more fluid reservoirs (e.g., reservoirs 18 or 40) at the proximal end and / or the distal end via fluid lumen 16, and the infusion fluid is pressurized and the bladder or For delivery in the bladder neck, it moves through the fluid lumen 16 to the extendable needle 30 and injects or contacts the bladder neck tissue. FIG. 1 shows an infusion fluid 45 that has been infused to enter tissue 44. The pressurization mechanism is shown as a mechanical injector 24 at the proximal end 20, but can optionally be any type of pressurization mechanism.

  Other features of the device 10 of FIG. 1 include a selective balloon port 52 at the proximal end 12 in communication with a balloon (not shown) at the distal end 12. Balloon port 52 may be used to provide fluid that pressurizes and inflates the balloon when the selective balloon is placed in the bladder. A proximal discharge outlet 54 is shown at the proximal end 20 and is connected to a discharge orifice 42 at the distal end 12 via a discharge tube hole (not shown). A slidable handle or “trigger” 50 at the proximal end is mechanically engaged with the expandable needle 30 via the movable bore 16, and the trigger 50 moves the needle 30 and shafts the needle 30. It can be moved from 14 to expand or contract. In the illustrated embodiment, the trigger 50 can be activated independently of the injector 24 so that the trigger 50 can be used to extend or retract the needle 30 and the injector 24 releases fluid from the needle 30. Can be activated separately.

  Branched FIG. 1A shows the internal mechanism of the device, which is an assembly that includes a plurality of needles 30 in communication with a distal hollow fluid reservoir 40. The assembly is movable as a single assembly within the device, and when moved proximally (in the direction of the arrow in the bore 16), the needle 30 is proximally and laterally away from the shaft 14. Stretch. The distal reservoir 40 is connected proximally to the fluid delivery tube bore (16) and extends through the length of the shaft 14 of the device 12 to the movable injector 24 at the proximal end 20 of the device 12. The distal reservoir 40 is also connected to a plurality of hollow needles 30 disposed on the proximal end side of the reservoir 40 and extending toward the proximal end 20 of the device 10. As shown in FIG. 1, the trigger 50 moves the assembly of the reservoir 40 and needle 30 (and movable lumen 16) proximally to extend the needle 30 from the shaft 14 at the distal end 12 of the device 10. Can be used for. Fluid in the lumen 16, proximal reservoir 18, movable tip reservoir 40 and movable needle 30 can be pressurized by use of the plunger 25 of the injector 24 and fluid can be immediately released from each of the orifices 32 of the needle 30. .

  FIG. 2 shows a fluid dispensing device that blindly dispenses fluid to the bladder neck using a needleless dispensing device. The apparatus 100 generally includes a distal end 102, a proximal end 104 including a body 106 and a pressure source (injector) 108 attached to the body 106, and a shaft 110. Shaft 110 includes a fluid delivery bore 116 therein that connects fluid reservoir 118 of injector 108 at proximal end 104 to paddle 130 and fluid delivery orifice 132 at distal end 102. Each first mounting end 140 of the paddle 130 is connected to the shaft 110 by a hinge connection. Each movable end 142 of the paddle 130 includes a single fluid delivery orifice 132. Each paddle 130 swings on the mounting end 140 and moves laterally away from the shaft 110 (as represented by the arrow), and each fluid delivery orifice 132 at the movable end 142 is spaced apart from the shaft 110 and expanded. Let A body 106 including a plunger 105 coupled to an activation mechanism 120 is used to expand the paddle 130 away from the shaft 110 at the tip 102 of the device 100 at the location of each paddle 130 and pull it back toward the shaft. obtain. A fluid supply bore (not shown) connects the tip reservoir 144 to each paddle 130 and allows fluid to flow through a path connecting the proximal reservoir 118 to each orifice 132.

  The activation mechanism 120 is attached to the plunger 105 of the main body 106 at the proximal end and to the paddle 130 at the distal end, and when the plunger 105 moves, the movable end 142 of the paddle 130 is spaced apart from the shaft 110 and expanded. Pulled back towards (arrow direction). The paddle 130 is in fluid communication with the fluid reservoir 118 through the reservoir 144, through the fluid supply bore 116 that penetrates the shaft 110.

  As shown in this preferred embodiment, a single fluid delivery tube (116) is formed from a single proximal fluid reservoir (118), a single distal fluid reservoir (140), and a plurality of fluid delivery orifices (132). To allow a single type of fluid to be dispensed from a plurality of injection orifices 132 at the tip 102.

  During use of the device 100, the paddle 130 and the tip fluid reservoir 144 are placed in the bladder represented by the bladder tissue 146. The shaft 110 is installed in the urethra 150 by entering from the entrance 152. The drain orifice 146 allows drainage of urine from the bladder in use and is connected to the proximal end 104 via a drain tube hole (not shown) in the shaft 110. Each paddle 130 may be expanded in the bladder after movement of the device in the proximal direction by the operator and may function as a positioning mechanism by contacting the bladder or bladder neck tissue.

  Still referring to FIG. 2, the tip 102 includes a plurality of needleless fluid dispensing orifices 132 at each movable end 142 of the paddle 130. Each paddle 130 spreads laterally away from the shaft hinged at the distal end mounting end 140 of each paddle 130, so that each paddle 130 dispenses fluid in the proximal direction. Expands with an oriented dispensing orifice. The paddle 130 is retracted relative to the shaft 110, and the device 100 can be inserted into the patient's body, for example, via the passageway 152, and the paddle 130 can be placed in the bladder, for example, near the bladder neck. Once installed, the paddle 130 expands laterally and proximally by pivoting on the attached (hingeed) end 140 as shown, expanding from the shaft 110 and so on. Thus, the movable end 142 of the paddle 130 contacts the tissue 146 of the bladder or bladder neck. Each paddle 130 may be separated and connected separately or together to the proximal end 104 of the device 100 via one or more fluid delivery bores 116. The infusion fluid is pressurized in a reservoir (e.g., 118) at the proximal end 104 of the device 100, passes through a fluid delivery tube (116), optionally through a distal fluid reservoir (e.g., distal reservoir 144) at the tip 102, and then enters the paddle. Each of 130 is dispensed in the bladder or bladder neck via a needleless fluid dispensing orifice 132 at the end of each paddle. The pressurizing mechanism may be in any form such as a plunger 109 of an injector (108) controlled by a power source external to the device.

  Other features of the apparatus of FIG. 2 include a flexible shaft (shaft 110) that includes a discharge tube hole (not shown) that communicates with the discharge orifice 146. The actuator (main body 106 and plunger 105) that deploys each paddle 130 is connected to the shaft 110 at the proximal end 104 and mechanically connected to the paddle 130 at the distal end 102, and the paddle 130 is between an expanded position and a retracted position. It can be activated to rock. Since the actuator can be activated independently of the syringe 108, the actuator is used to expand or retract the paddle 130 and the injector 108 is activated separately to expel fluid from the fluid dispensing orifice 132. obtain.

  FIG. 3 shows another embodiment of a fluid dispensing device (160) that blindly dispenses fluid to the bladder or bladder neck (180) using a needleless dispensing device. The tip 164 includes a plurality of needleless fluid dispensing orifices 168 at the movable ends 182 of the plurality of paddles 166. Each paddle 166 is moved laterally from the shaft 190 by movement of an internal assembly including, for example, the paddle 166 and optionally a pressure reservoir (reservoir) 170 containing fluid infusion, a plunger 174, and a power source 172. Can be spread apart (as indicated by the arrows). A fluid delivery tube hole connects the tip reservoir 170 to each paddle 166. Depending on suitability and application, the device 160 may be used to dispense a single type of fluid, together or independently, through each of the orifices 168. Alternatively, device 160 may dispense multiple types of different fluids, such as different fluids from two or more of each paddle, for example. The dispensing of multiple types of fluids can be accomplished, for example, by using one tip reservoir for each fluid and installing multiple tip reservoirs at the tip 164. Each distal reservoir can be activated independently by a mechanism at the proximal end 162.

  In one embodiment, each paddle 166 is expanded laterally (integrally or independently) from the shaft 190 and pivoted at a hinge connection between the shaft 190 and the mounting end 184, Can refer to the proximal direction. Each paddle 166 is pulled back to position against the shaft 190, and the tip 164 of the device 160 is inserted into the patient's body, for example, to place the paddle 166 in the bladder near the bladder neck. Each paddle can function as a positioning mechanism. Once the tip 164 is in place, the paddle 166 is spaced apart from the shaft 190 and widened laterally as shown, so that the movable end 182 of the paddle 166 contacts the bladder tissue 180. Each paddle can be expanded (integrally or independently) by movement of the activation mechanism 176 at the proximal end 162. Each paddle 166 may be separately or integrally connected to the tip pressure vessel 170 at the tip 164 of the device 160. The fluid in the pressure vessel 170 may be pressurized by movement of the plunger 174 using a power source 172 (eg, pressurized carbon dioxide) that may be activated by an actuator or “trigger” 175 at the proximal end 162.

  Other features of the apparatus of FIG. 3 include a flexible shaft (190) and a “trigger” (activation mechanism 176) at the proximal end 162 useful for deploying each paddle 166. A trigger 175 that discharges infusate (fluid) is shown at the proximal end 162 of the device 160 and is mechanically or electronically coupled to the power source 172 (as indicated by the dashed line) to cause fluid in the fluid reservoir 170 to flow. Upon pressurization (by movement of the plunger 174), fluid is discharged from the needleless fluid dispensing orifice 168 at the movable end 182 of each paddle 166. The dashed line between the activation mechanism 176, trigger 175 and tip 164 represents the mechanical or electronic connection between these elements of the device 160 from the proximal end 162 to the extent necessary to activate the characteristic tip structure. Yes. As mentioned, multiple tip and proximal reservoirs connected by multiple fluid delivery bores can be used to allow for the dispensing of more than one fluid. The fluid may be pressurized and injected into the tissue or released to contact the tissue without entering the tissue (ie, instilled on the surface of the tissue). As shown, fluid 192 is injected into tissue 180 and penetrates.

  Referring to FIG. 4, the tip of the fluid dispensing device is shown. The tip 200 includes a shaft 202, multiple groups of needleless dispensing orifices 204 and 205, tip fluid reservoirs 208 and 209 (both are selective and can be replaced by standard branch tubing), fluid dispensing tubes Holes 212 and 213 and movable covers (eg, sleeves) 206 and 207 are included. Covers 206 and 207 are shown as sleeves, one sleeve for each group of dispensing orifices 204 and 205. Optionally, the cover is any other type of single or multiple covers that may allow a single orifice or multiple orifices to be opened and closed independently at once, covering or exposing or opening or closing the orifices It may be any form of movable wall, door, flap or other barrier such as a barrier that can move. For example, each of the four orifices 204 shown may have a separate cover that can be opened and closed independently. Similarly, each of the four illustrated orifices 205 may have a separate cover that can be opened and closed independently.

  The fluid dispensing orifices 204 communicate with each other via a selective reservoir 208 and with a fluid dispensing tube hole 212, and the fluid dispensing orifice 205 communicates with each other via a selective reservoir 209 and a fluid dispensing tube. It communicates with the hole 213. Each group of orifices is combined with a movable cover (206, 207), each cover being independently movable and controllable from the proximal end of the device (eg, mechanically or electronically), and orifices 204 and 205 Can be controlled separately. The exemplary device includes two separate fluid delivery tube holes (212, 213), two sets of fluid delivery orifices (204, 205), two sets of selective reservoirs (208, 209), and one type of fluid for each. Two independently actuated sleeves (206, 207) are shown that cooperate to allow independent dispensing of two different fluids through a fluid dispensing tube bore and a group of orifices. If desired, it is possible to add two (e.g., third, fourth, fifth, or more) fluid delivery bores, orifices, selective reservoirs, and sleeves (e.g., a cover) from the tip 200 to the second. More types of different fluids can be provided.

  FIG. 4 shows the dispensing device tip including two sets of needleless dispensing orifices 204, 205, each group of orifices being “in series” (in communication with each other) and flexible device shaft. Located at different locations along the length of 202. Each needleless dispensing orifice 204 (205) is positioned near or behind a movable cover (e.g., sleeve) 206 (207), which moves along the length of the shaft 202, and a single orifice 204 or 205 As such, or in combination with one or more additional orifices (204 or 205), each orifice 204 may be exposed or covered (opened and closed). Although only one cover is shown for each group of orifices 204 and 205, as an alternative to allowing each orifice to be opened and closed independently, two or more can be provided for each group of orifices as desired. Covers can be combined.

  Each dispensing orifice is connectable to another orifice (e.g., each orifice 204 is in fluid communication with each other and each orifice 205 is in fluid communication with each other but not in fluid communication with the orifice 204), and It can be coupled to a common fluid source (eg, a proximal fluid reservoir (not shown) at the proximal end of the device). The fluid source is pressurized and can dispense fluid from each dispensing orifice connected without being covered by a sheath, and the fluid can be any one of a plurality of dispensing orifices coupled to a fluid source. Independently or from two or more of a plurality of orifices connected to a common fluid source.

  Still referring to FIG. 4, covers (sleeves) 206 and 207 are shown as external to shaft 202. Cover 206 may cover one or more fluid delivery orifices 204. Independent of sleeve 206, sleeve 207 may cover one or more fluid delivery orifices 205. As will be appreciated, each cover 206 and 207 is covered or exposed with one or more dispensing orifices 204 or 205 as desired to allow fluid flow from any exposed (opened) dispensing orifice 204 or 205. It is independently mechanically activated and moved relative to the shaft 202 to allow it to be dispensed. The tip 200 of FIG. 4 is also shown including a central drainage lumen 210 and drainage aperture 211 that allow drainage from the bladder when the tip 200 is placed in the patient's body.

  Optionally, the tip 200 can include features such as a steerable shaft that allows the end 200 to be steered (eg, articulated) during attachment and fluid delivery. Similarly, the tip 200 can be used to allow observation of the dispensing location, the precise placement location of the tip 220, orifices 204 and 205, and the fluid dispensed through the orifices 204 and 205 in use. It may also include an optical feature leading to the proximal end.

  FIG. 5 illustrates another embodiment of a portion of the tip (220) of the fluid dispensing device. The device includes a rigid or preferably flexible shaft (222) that allows fluid to flow in place in the lower urinary tract or nearby tissues such as the bladder, bladder neck, urethra, kidney, ureter, etc. or their interior. Can be dimensioned and designed to release A plurality of sleeves 226 are shown outside the shaft 222 of the device, and these sleeves 226 can move independently of one another along the length of the shaft 222 in one direction and cover one or more dispensing orifices 224. Each sleeve 226 is provided along the length of shaft 222 such that one or more dispensing orifices 224 are covered (closed) or exposed (opened) and fluid is dispensed from any open dispensing orifice 224. Can be mechanically activated. A discharge tube hole 228 and a discharge opening 230 are shown. A drain tube hole 228 connected to the drain aperture 230 is positioned along the side of the tip 220 and extends to the proximal end to allow drainage of urine from the bladder when the device is installed in the patient's body To do. A plurality of fluid dispensing means 232 including pressure sources, reservoirs or both may be located at a certain location within the tip 220, eg, adjacent to each orifice 224. Each fluid delivery means 232 may include a pressure source located at the distal end of the device, or the pressure source may be located at the proximal end (not shown). A fluid delivery tube hole (not shown) connects each fluid delivery means 232 to the proximal end of the device. The pressurization of each dispensing means 232 is an activation mechanism disposed at the proximal end of the device, and is a fluid that is mechanically or electronically connected to a pressure source (at the proximal end or the distal end of the device) and dispensed at the distal end. Can be individually controlled by an activation mechanism that pressurizes the. The dashed line for each fluid delivery means 232 represents an electronic or mechanical connection to the proximal end to allow activation of the fluid delivery means 232 for fluid delivery.

  As used herein, the expression “fluid dispensing means” is one or more of one or more structures and mechanisms, used to discharge fluid from a fluid dispensing orifice, including a pressure source, a fluid reservoir, Refers to structures and mechanisms that include separate or combined members such as tube holes and activation mechanisms.

  Optionally, tip 220 includes features such as a steerable shaft to allow end 220 to be steered (eg, articulated) during installation and fluid delivery. Similarly, the tip 220 may be a base of the apparatus that allows for observation of the dispensing location in use and the precise placement of the tip 220, orifice 224, and fluid dispensed through the orifice 224. An optical feature leading to the edge may also be included.

  6A and 6B are embodiments of the apparatus described herein that include a plurality of extensible fluid delivery orifices, ie, fluid delivery orifices disposed at the end of an orifice extension. The form is shown. Referring to FIG. 6A, the tip 230 includes a shaft 232, a dispensing orifice 234 at the length or end of the orifice extension 236. The dispensing orifice extension 236 includes a flexible exterior and an expandable bore 235 connected to a fluid dispensing means 242 that may include a fluid reservoir, a pressure source, or both. Each fluid dispensing means 242 is independently connected to the proximal end by a mechanical or electronic connection, and the means 242 can be independently moved and activated (connection is indicated by a dashed line). A fluid delivery tube hole (not shown) connects each fluid delivery means 242 to the proximal end of the apparatus. Each fluid dispensing means 242 can control a single type of fluid source so that multiple types of different fluids can be dispensed from the tip 230, or optionally coupled to different fluid sources containing the same fluid Different means 242 can be used to dispense the same fluid.

  The extendable drain tube hole 248 is connected to the drain aperture 250 and the proximal end (not shown) of the device located at the proximal end of the shaft 232. The drain tube hole may extend longitudinally, laterally, or both beyond the leading edge 252 and act as a positioning mechanism as well as a drain tube hole.

  A plurality of extensible fluid dispensing orifice extensions 236 are shown in a retracted position in FIG. 6A, where each dispensing orifice extension 236 is retracted and positioned within shaft 232 at tip 230. A fluid delivery orifice 234 is located at the end of each extensible bore 235 and on the sides of several extensible bores 235 as shown. Each extension 236 is an exterior, which may be a flexible, rigid or semi-rigid extension or “finger”, spaced distally from the proximal end of shaft 232 and extending generally over the fluid delivery device And extending remotely and selectively laterally away from the tip or tip 252. The extension 236 may be formed of an elastic polymer material such as silicone, polyurethane, rubber or latex, or may be further formed of a rigid material. Each extension 236 is biased to be activated such that each extension 236 extends beyond the leading edge 252 of the tip of the device and protrudes from the leading edge 252 so that each extension 236 In addition, when extending so as to provide a predetermined distance between the tips of the extension portions 236, the extension portions 236 are spread or fanned apart to the side. Each extension 236 moves away with the component in the direction away from the axis 254 along the virtual long axis (254) of the shaft 232 in the distal direction and laterally, ie, away from the leading edge 252. The fan-shaped or outward expansion of each orifice extension 236 provides a predictable distance between the dispensing orifices 234 located in each extension 236.

  The device of FIG. 6A, for example, places a plurality of fluid delivery orifices in the urethra, bladder neck or bladder, etc. to dispense the same or different types of fluid to one or more locations of these tissues. Useful for. FIG. 6B shows the tip 230 of such a device with elongated fingers (ie, elongated orifice extensions) 236, each finger 236 being an extensible bore 235 that extends along a portion of the length of the finger 236. An extensible bore 235 that allows the discharge of fluid from one or more fluid delivery orifices 234 in the longitudinal direction at or along the ends of the fingers 236. The discharge tube hole 248 likewise extends. An individual fluid delivery means 242 for each finger 236 and extendable bore 235 includes a fluid reservoir containing fluid and an optional pressure source, and from the proximal end by a mechanical or electronic connection (shown as a dashed line). It can be activated or pressurized independently. One or more fluid reservoirs of each means 242 are pressurized so that upon pressurization, fluid is released from one or more orifices of each extended finger 236. The pressure may be supplied as desired by use of compressed carbon dioxide at the tip or proximal end of the device, or by a mechanical spring, solenoid or pump, or another type of pressure source at the proximal end of the device. . Each fluid dispensing means 242 can be independently or integrally controlled from the proximal end of the device (not shown) to independently dispense a single type of fluid.

  Optionally, the tip 230 includes a steerable tip or tip so that the tip 230 can be steered during installation and fluid delivery. Similarly, the tip 230 is an optical feature that leads to the base end of the device and is visually coupled to the base end, in use, the dispensing location, the tip 230, the precise placement location of the orifice 234, And may include optical features that allow observation of fluid dispensed through the orifice 234.

  7A and 7B show another embodiment of the tip of the device according to the present invention. FIG. 7A shows dispensing orifices connected in series to dispense a single type of fluid from a plurality of tube holes. That is, a “daisy chain” configuration of a plurality of adjacent fluid delivery orifices disposed along the length of the distal end of the device and proximal to the balloon is shown. FIG. 7B shows a similar embodiment that instead includes “parallel” fluid delivery orifices, each of which can be independently controlled to dispense different types of fluids (all of the activation mechanisms and fluid delivery bores are not shown). is there).

  FIG. 7A shows a fluid delivery device tip 260, which includes a fluid delivery orifice 262, a cover 264 that can optionally cover one or more orifices 262 (eg, a needleless fluid delivery orifice), and a shaft 268. And an inflatable balloon 274 and a discharge aperture 272 at the tip 270 of the tip 260. Each fluid delivery orifice 262 is located at a location progressively toward the tip along the length of the shaft 268 and (as shown) adjacent to the shaft periphery or at the shaft periphery. It is provided at different positions around. Balloon 274 may be placed in the bladder to help properly position tip 260 during use. A discharge opening 272 at the leading edge 270 of the device is connected to a discharge tube hole (not shown) that extends through the shaft 268 to the proximal end (not shown) of the device. Each fluid delivery orifice 262 is exposed separately or in any desired combination, and fluids for injection or instillation into the place by the desired combination along the length of the installed device or around the periphery of the device. One or more independently controllable sleeves 264 may be used to allow dispensing.

  FIG. 7B shows a similar apparatus, except that each dispensing orifice 262 is not connected in series to a common fluid source, but each orifice 262 is connected to a different fluid dispensing means 263 to allow dispensing different fluids. Show. Three fluid delivery tube holes (not shown) connect each of the three fluid delivery means 263 to the proximal end of the device.

  Optionally, the tip 260 includes features such as a steerable tip so that the end 260 can be steered during installation and fluid delivery. Similarly, the tip 260 leads to the dispensing point in use and the proximal end of the device that allows precise placement of the tip 260, the orifice 262, and the observation of fluid dispensed through the orifice 262. It may include optical features.

  FIGS. 8A and 8B include a plurality of dispensing orifices disposed in a mechanical orifice extension (“finger”) that extends and expands beyond the tip of the dispensing device shaft as described herein. Figure 4 shows another embodiment of the apparatus. Each extensible finger 282 includes one or more dispensing orifices 280 in communication with a separate fluid means 286, each of the fluid means injecting a plurality of different fluids into tissue such as the bladder, urethra, bladder neck, or the like. It can be independently pressurized to release different fluids from each orifice of the means for instillation. The extensible positioning mechanism 284 is a stretchable structure that can be stretched and contracted by a mechanism at the proximal end of the device and may or may not include a drain tube hole. FIG. 8A shows each finger 282 extended and expanded outward when the device is installed in the urethra 290 and bladder 292, and the extended positioning mechanism 284. FIG. FIG. 8B shows the fingers contracted for placement through the urethra 290.

  9A, 9B, and 9C illustrate another embodiment of a device that includes a plurality of fluid delivery orifices that are extensible or expandable in a direction that includes a distant component from the distal tip of the device. . This example includes an expandable “nozzle”, “funnel” or “fan” shaped orifice extension 358, such as a thin film, where the expandable portion of the device contains a plurality of fluid delivery orifices 356, each orifice being Via a tube 360 is connected to a fluid reservoir or fluid delivery means 362 that can be pressurized to release fluid from the orifice of a single tube 360. The extension 358 may be formed of an elastic polymer material such as silicone, polyurethane, rubber or latex, or may be a more rigid material. The extensible lumen 360 is received by an extension 358 and each includes a plurality of orifices 356. As shown in FIGS. 9A and 9B, different orifices 356 can be coupled to separate fluid sources so that the device can dispense multiple different fluids or different types of fluids. Optionally, all orifices 356 can be coupled to a single fluid source for dispensing from a single fluid source.

  Referring to FIG. 9A, the fluid delivery device tip 350 includes an open or hollow tip 352 of a shaft 359 that further houses a movable orifice extension 358. In FIG. 9A, the orifice extension 358 is shown in a contracted state received by the shaft 359. In FIG. 9B, the orifice extension 358 is shown in an expanded state extending away from the leading edge 352 and laterally. As shown in FIG. 9B, the orifice extension 358 is in the form of a thin film that expands into a three-dimensional fan shape when stretched from the leading edge 352. The membrane can be coupled to a fluid reservoir that is either a distal reservoir (362, disposed at the distal end of the fluid dispensing device as shown) or a proximal reservoir (located at the proximal end of the fluid dispensing device). A dispensing orifice 356 is included. A fluid delivery tube hole (not shown) connects each reservoir or means 362 to the proximal end. The dashed line represents a mechanical or electronic mechanism that separates and activates each reservoir or means 362 independently, and each reservoir 362 communicates with the proximal end of the device to independently move or activate the reservoir or means 362. And allows independent fluid delivery. A fluid delivery tube 360 extends from each means or reservoir 362 to each fluid delivery orifice 356. Orifice extension 358 is also coupled to the proximal end to allow activation or movement of extension 358 from a predetermined location at the proximal end.

  FIG. 9C shows another embodiment that includes one fluid dispensing means 362 for each single fluid dispensing orifice 356.

  Optionally, for the device shown in FIGS. 9A, 9B, and 9C, the fluid reservoir may be at the distal or proximal end of the device, and the pressurization mechanism (eg, carbon dioxide, plunger, etc.) may also be It may be provided at the proximal end or the distal end. An orifice extension (fan) 358 containing the fluid dispensing orifice 356 extends beyond the leading edge 352 at the distal end of the dispensing device shaft 354 and expands at the proximal end of the device by an orifice extension activation mechanism. Start and expand. Orifice extension (fan) 358 may include one or more dispensing orifices 356 at various locations along the length or circumference of fan 358. This is because the fan 358 is in the extended or expanded position. 9B and 9C show the expanded state of the fan 358, the fan or “funnel” shape and exemplary form of the fluid dispensing orifice 356, the bore 360 between each orifice 356 and the fluid dispensing means or reservoir (eg, 362). And a pressure mechanism (not shown). Each orifice 356 of the fan 358 is a fluid reservoir (e.g., 362, which can be pressurized to release fluid from each orifice 356 for injection or instillation into tissues such as the bladder, urethra, kidney, ureter, bladder neck, etc. Communicating with the proximal or distal end of the device.

  Optionally, the tip 350 includes features such as a steerable tip, and the end 350 can be steered during installation and dispensing of fluid. Similarly, the tip 350 may be used at the proximal end of the device to allow for precise placement of the dispensing site and the tip 350, orifice 356, and fluid dispensed through the orifice 356 in use. May include optical features leading to

  10A and 10B illustrate yet another embodiment of a device that includes a plurality of dispensing orifices that can extend or bulge from the tip of the device. Referring to FIG. 10A, fluid dispensing device tip 370 includes an open or hollow tip 372 of shaft 382 and an orifice extension 378. The orifice extension 378, which is a balloon at the leading edge 372 of the shaft 382, is shown in an expanded state in FIG. 10A, extending or protruding away from the leading edge 372 and laterally. The extension 378 can be formed of an elastic polymer material such as silicone, polyurethane, rubber or latex, or can be formed of a more rigid material. FIG. 10A is a side view of a device with two dispensing orifices 380. FIG. Each orifice 380 may be coupled to a different fluid delivery tube hole 374 to dispense a different fluid. Optionally, each orifice can be connected to the same fluid source, or there can be additional orifices.

  FIG. 10B is an end view of a configuration similar to that of FIG. 10A but including eight orifices 380. Each orifice 380 can be connected to a different fluid delivery tube hole 374 to dispense different fluids, or two or more orifices can be connected to the same fluid source. The extension 378 is in the form of a balloon that expands in three dimensions when inflated. Balloon 378 includes a fluid dispensing orifice 380 that can be coupled to a fluid reservoir that is either a distal reservoir at the distal end of the fluid dispensing device or a proximal reservoir located at the proximal end of the fluid dispensing device. A fluid delivery tube hole may extend from the reservoir to each fluid delivery orifice 380.

  The exemplary device of FIGS. 10A and 10B includes an inflatable balloon configuration, wherein the inflatable balloon contains a plurality of fluid delivery orifices, each orifice being pressurized to release fluid from a single orifice ( It is connected to a fluid reservoir (not shown). The fluid reservoir may be positioned at the distal end or proximal end of the device, and a pressurizing mechanism (eg, carbon dioxide, plunger, etc.) may be positioned at the proximal or distal end of the device. A balloon 378 that houses a fluid delivery orifice 380 expands upon inflation using an inflation fluid that can be dispensed from the proximal end of the device through an inflation tube connecting the balloon to the proximal end. As the balloon expands, each fluid dispensing orifice moves past the tip of the dispensing device shaft and is installed there. The balloon fills or partially fills the inside of the bladder and expands so that the fluid delivery orifice contacts the internal tissue of the bladder. As the balloon is inflated, each fluid delivery orifice extends with the balloon surface to be spaced from each other and is positioned proximate to the surface of the bladder internal tissue. Each of the orifices of the balloon can be any from the end of the shaft, either uniformly around the balloon as shown in FIG. 10B, or in a different pattern with different spacing from the base of the balloon on the shaft of the device, or randomly. It can be arranged at a desired distance or radially. Each orifice may be the same distance or a different distance from the end of the shaft.

  FIG. 11 shows yet another embodiment of a device that includes one or more (shown) dispensing orifices that can protrude from the tip of the device. Referring to FIG. 11, the tip 390 of the fluid dispensing device includes a tip 398 of a shaft 396 and further contains an orifice extension 392. Orifice extension 392 is in the form of an expandable bore or “finger” that extends away from distal end 398 of shaft 396. The extensible orifice extension 392 or “finger” includes a fluid delivery orifice 394 at the tip. Each orifice extension 392 or “finger” can be steered using an actuation mechanism at the proximal end of the device, for example, using the steering mechanism described above for the steerable shaft. Similarly, each orifice extension 392 is biased and extended away from the leading edge 398 by operation of an activation mechanism at the proximal end of the device, if desired. Each orifice 394 can be coupled to a fluid reservoir that can be pressurized to release fluid from a single orifice. The fluid reservoir is installed at the distal end or proximal end of the apparatus or spaced from the proximal end, and a pressurizing mechanism (for example, carbon dioxide, plunger, mechanical spring, pump, solenoid, etc.) is provided at the proximal end or distal end of the apparatus. May be.

  In accordance with certain embodiments of the present invention, tip 390 may include features such as a steerable tip that steers end 390 during installation and fluid dispensing. Similarly, the tip 390 leads to the dispensing point in use and the proximal end of the device to allow precise placement of the tip 390, orifice 394, and observation of fluid dispensed through the orifice 394. It may include optical features.

  FIG. 12 shows another preferred embodiment of the device according to the invention. Device 400 includes a proximal end 402 and a distal end 404 connected by a shaft 403. Proximal end 402 includes a body or handle 412 that houses features useful for manipulating or operating features at distal end 404. The body 412 two-dimensionally steers the steerable tip of the device 400 based on the fiber optic light source 416 and the differential push and pull (or tension and compression) of multiple cables in the shaft wall (not shown). A steering actuator 414 that can be manipulated to move, a viewing lens 420 that allows observation of a fluid delivery location through the leading edge 422 via a fiber optic cable 410, and a fluid source connection to the proximal end 402. Port 424 to enable. The articulation for the manipulation of the end 404 is shown in broken lines.

  Still referring to FIG. 12, a mounting adapter 426 is attached to the port 424 and the fluid dispensing means 428 can be coupled to the body 412. The fluid supply means 428 is a mechanism that pressurizes the fluid reservoir with the fluid reservoir, the pressure source, and the pressure source, and passes the fluid from the fluid reservoir through the port 424 to the fluid tube hole 408 (the operation tube hole). , Which is movable longitudinally within 418) and finally ejected as fluid jetted injection 432 from fluid conduit 408 at fluid dispensing orifice 430. By manipulating an actuator (not shown) at the proximal end 402, the expandable fluid tube hole 408 can be expanded and contracted in the distal direction.

  The body 412 is coupled to a shaft 403 that includes a bore and a mechanism that couples the features of the proximal end 402 to the distal end 404. The working bore 418 is a hollow bore or channel that allows the fluid delivery bore 408 to move longitudinally along the length of the shaft 403, with the tip of the fluid delivery bore 408 being the most advanced orifice extension. Extends within the shaft 403 and accommodates the fluid delivery bore 408 to allow extension from 422. The shaft 403 also includes an optical fiber 410 and a steering mechanism (not shown) that allows the tip 464 to be steered (deflected) by movement of the actuator 414. The light source 416 transmits light to the tip 404 through the optical fiber 411.

  The tip 404 includes a leading edge 422 from which the fluid delivery bore 408 can extend as an orifice extension. The tip 404 is steered two-dimensionally based on observation through the optical fiber 410 to enable the movement of the most advanced 422 in cooperation with the extension of the tube hole 408, and with precise placement at the desired tissue location. Can be provided. Optionally, proximal to the illustrated steerable section, another steerable section of shaft 403 is included, and in an additional plane, such as a plane orthogonal to the articulation plane shown in FIG. Allows the tip to articulate.

  FIG. 13 shows a modified example of the device 400. In FIG. 13, the port 424 is not connected to the proximal fluid supply means 428 as shown in FIG. 12, but is connected to a remote fluid source 440. In particular, the device 400 is connected to a flexible conduit 446 via a port 424 that includes a fluid conduit that allows fluid communication between the port 424 and the fluid reservoir 440. A fluid reservoir 440 is housed in a remote console 442 that houses a fluid reservoir 440 and a pressure source 444 that can pressurize the fluid contained by the fluid reservoir 440. The “remote” console 442 is a desired distance from the body 412 that allows for easy operation and use of the device 440 while allowing the weight and volume of the pressure reservoir away from the fluid reservoir and body. The “remote” console may be positioned 2 feet to 20 feet (60.96 to 609.96 cm) away from the user of the device 400, for example, and the flexible conduit 446 is 4 feet to 30 feet (about 121.92 to 914.4 cm) long. The corresponding length can be as follows.

  The use of the console shown in FIG. 13 is not limited to its usefulness in combination with a device having the detailed features of device 400. A remote console, such as console 442, may be used with any of the devices or features described herein or shown in any of FIGS.

  14 and 15 illustrate a dose control device (500) that can be incorporated into any of the fluid dispensing devices described herein. The dose control device 500 generally includes a plunger / shaft assembly 502 and a stop member 504. The dispense volume controller 500 may be made of a suitable material such as a metal such as stainless steel and nitinol, or optionally a suitable polymeric material. The plunger / shaft assembly 502 can include a shaft member 506 and a stepped engagement member 508. The stepped engagement member 508 is generally disposed circumferentially around the shaft member 506 and may include a first engagement portion 510, a second engagement portion 512, and a third engagement portion 514. . Each of the engagement portions has a distinct diameter that decreases from the first engagement portion 510 to the second engagement portion 512 and finally to the third engagement portion 514. Each engagement portion includes a first engagement surface 510a on the first engagement portion 510, a second engagement surface 512a on the second engagement portion 512, and a third engagement on the third engagement portion 514. Includes an engaging surface such as surface 514a. The shaft member 506 generally extends from the third engagement portion 514 to a plunger (not shown) at the end of the shaft assembly 502 opposite the stepped engagement portion 508.

  The plunger may pressurize and displace fluid in the plunger reservoir. As can be appreciated, the travel distance of the plunger at the end can be controlled by the movement of a stop member 504 that engages a different surface of the engagement member 508 to control the volume of fluid displaced by the plunger.

  The stop member 504 generally includes a stop body 516 that forms a stop surface 518. Stop member 504 can be operatively mounted within shaft 507. The stop member 504 is generally placed so as to be holdable in the surface opening 509 by using an appropriate holding mechanism such as, for example, friction fitting, magnetic coupling, detent means, latch surface, spring load holding member or the like. Configured.

  In use, the stop member 504 is biased into the surface opening 509 of the shaft 507 such that a desired amount of stop surface 518 is present in the shaft 507. The amount of stop surface 518 within shaft 507 is selected based on whether it is desired to engage first engagement surface 510a, second engagement surface 512a, or third engagement surface 514a. By selecting which engagement surface should be engaged, the stroke length of the plunger / shaft assembly 502 is limited so that each full stroke delivers the same measured amount of fluid as the plunger moves. . The selective placement of the stop member 504 allows the medical professional to change the measured amount of therapeutic fluid that is ultimately administered with each stroke of the plunger / shaft assembly 502.

  Any individual component of the device, or the entire device may be disposable or reusable. As an example, a disposable or reusable optical feature of the type used with an endoscopic device can be incorporated into a part or one component of the device that is disposable or reusable. Additionally or alternatively, the device may have a reusable pressure source (eg, a pressurized gas cartridge), a replaceable fluid reservoir, a disposable dispensing head, or entirely disposable Could be possible.

  In another specific embodiment, the device can be designed to dispense different amounts of fluid at different tissue locations. Thus, fluid dispensing occurs between the steps of changing the fluid dispensing orifice, where one or more fluid dispensing orifices are selectively movable relative to the shaft or extendable from the shaft. Different amounts of fluid can be pre-loaded individually into a predetermined amount of replaceable vials as desired, for example, for single or multiple fluid delivery. That is, a single vial may contain a single dose (volume) or multiple doses (volume) of fluid. Using replaceable vials, the device can be used to dispense one or more doses of fluid using the entire volume of one vial. The replaceable vial can then be removed from the fluid dispenser and replaced with a full vial, and the full vial volume can be supplied in one or more fluid dispenses. This can be repeated for as many fluid donations as desired. In another embodiment, the device has a connection at its proximal end that connects the device to a remote fluid source (eg, a “hopper” or remote console) from which the individual vials can be loaded or The desired amount of multiple fluid dispenses can be procured without the need for reloading.

  In accordance with any of the above features of the fluid delivery device, the device may vary in various locations, amounts, and degree and depth of fluid dispersion (e.g., shape and distance), and other infusion characteristics such as particle dimensions. An electronic process control system that can be programmed to provide fluid delivery.

  The present invention is also a method for delivering fluid to tissues of the lower urinary tract and nearby tissues, such as the bladder or bladder neck, kidney, ureter, urethra, prostate tissue, and the like substantially as herein. Deploying a fluid source and fluid dispensing device as described, inserting a fluid dispensing device into a patient's body, for example via a portal, and a fluid dispensing orifice at the tip of the device at the desired dispensing site Maneuvering the device until it is positioned, optionally activating features at the tip of the device, such as opening a cover or port, to expose the fluid delivery orifice, and including the fluid delivery orifice Inflating, expanding or expanding a fan, finger, balloon or other extension of the device, and activating the device to place one or more orifices in the site from one or more orifices; And a step of donating a plurality of types of fluids, there is provided a method. Multiple delivery orifices may provide the ability to supply one or more different fluids to multiple locations such as the urethra, prostate, bladder, or bladder neck. Features of the devices described herein such as optical features, steerable shafts, projectable or movable fluid delivery orifices, and the ability to independently open and close selected fluid delivery orifices, and multiple types The ability to dispense different fluids allows excellent control over the point of fluid injection or instillation.

  An exemplary treatment method may include one or more individual steps related to insertion of a fluid delivery device as described herein. Positioning the device and placing one or more fluid delivery orifices at a desired location in the bladder or bladder neck or other location in the urinary tract, optionally using an optical device, optionally the device Extending a needle or needle-free delivery orifice extension from the shaft of the needle into contact with tissue such as the bladder or bladder neck, one or more bioactive fluids or agents from the delivery orifice (needle or needle-free delivery orifice) In contact with or infiltrate tissue such as the bladder or bladder neck, optionally one or more steps to reposition one or more fluid delivery orifices, optionally the same or different delivery orifices One or more additional donation stages including.

  In accordance with the fluid delivery procedure of the present invention, fluids such as ethanol or bioactive agents can be injected into the tissue using a needle or needle-free delivery orifice, or the fluid contacts the surface of the tissue. Thus, it can be delivered to the bladder, urethra, bladder neck or the like so that the bioactive component of the fluid is absorbed through the tissue.

  The devices described herein are useful for treating urinary tract tissue in women or men. For example, the device of the present invention is useful for injection into the bladder, bladder neck, urethral tissue itself or external sphincter, or transurethral injection into the male prostate. In other embodiments, the fluid may be a drug or, for example, individual or combined treatment with other therapeutic agents such as botulinum toxin (“Botox”), anti-androgen substances, among others, as will be appreciated. Can be injected into tissues of the urinary tract (eg, bladder, urethra, kidney, ureter, prostate, etc.). One advantage of injecting the active pharmaceutical agent at the point of use is that the agent is placed to avoid systemic side effects. Specific examples of effective pharmaceutical agents include botulinum toxin types AG, 5-alpha reductase inhibitors such as dutasteride and finasteride, alfuzosin, doxazosin, prazosin, tamsulosin hydrochloride, alpha blockers such as terazosin for treating BPH Or various antibodies (eg, treating prostate) and any of the analgesics.

  Examples of the method using the apparatus include a method of supplying a plurality of types of drugs such as a plurality of types of drugs to urinary tract tissues such as the bladder, bladder neck, urethra, prostate, kidney, and ureter. According to one exemplary method, fluid is injected into the tissue. According to other exemplary methods, the fluid is instilled into contact with the surface of the tissue, i.e., dripped, e.g., washing the tissue (e.g. filling the bladder to wash the bladder tissue) or applying a therapeutic agent Grant. According to yet another exemplary method, fluid may be dispensed into the bladder to fill or partially fill the bladder.

  Other embodiments of the invention will be apparent to those skilled in the art from consideration of the above description, or by practicing the invention described and illustrated herein. Those skilled in the art will make various omissions, modifications and changes to the principles and embodiments described herein without departing from the true scope and spirit of the invention as illustrated by the exemplary embodiments. Let's get it.

1 is a schematic view of an apparatus of the present invention including a projectable fluid delivery orifice. FIG. 3 is a schematic view of the movable components of the apparatus of the present invention. 1 is a schematic view of an apparatus of the present invention including a projectable fluid delivery orifice. 1 is a schematic view of an apparatus of the present invention including a projectable fluid delivery orifice. FIG. 2 is a schematic view of an apparatus of the present invention including a plurality of independently functioning fluid delivery orifices. FIG. 2 is a schematic view of an apparatus of the present invention including a plurality of independently functioning fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including multiple groups of projectable fluid delivery orifices. FIG. 1 is a schematic view of an apparatus of the present invention including multiple groups of projectable fluid delivery orifices. FIG. 1 is a schematic view of an apparatus of the present invention comprising a plurality of projectable fluid delivery orifices or groups of fluid delivery orifices. FIG. 1 is a schematic view of an apparatus of the present invention comprising a plurality of projectable fluid delivery orifices or groups of fluid delivery orifices. FIG. 1 is a schematic view of an apparatus of the present invention comprising a plurality of projectable fluid delivery orifices or groups of fluid delivery orifices. FIG. 1 is a schematic view of an apparatus of the present invention including a plurality of projectable fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of projectable fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a plurality of projectable fluid delivery orifices. 1 is a schematic view of an apparatus of the present invention including a steerable tip portion. FIG. 2 is a schematic view of an apparatus of the present invention including a steerable tip portion and a remote console. FIG. 6 is a cutaway side view of an embodiment of a dispense volume controller. FIG. 15 is an end view of the dosage controller of FIG. 14 taken along line 15-15 of FIG.

Claims (24)

The proximal end,
A flexible shaft extending from the proximal end to the distal end;
A fluid delivery orifice capable of projecting from the shaft at the tip;
A device that provides fluid to urinary tract tissue. The apparatus includes a body at the proximal end;
The body includes a pressure source and a fluid reservoir;
The fluid reservoir is in fluid communication with the fluid delivery orifice;
The pressure source may pressurize the fluid reservoir;
The apparatus of claim 1. The apparatus includes a remote console in communication with the proximal end;
The remote console includes a pressure source and a fluid reservoir;
The fluid reservoir is in fluid communication with the fluid delivery orifice;
The pressure source may pressurize the fluid reservoir;
The apparatus of claim 1. The device includes a paddle extension at the tip of the shaft;
The paddle extension includes an attachment end connected to the shaft and a movable end that can be expanded laterally from the shaft;
A fluid delivery orifice is provided at the movable end;
The apparatus of claim 1.   2. A fluid delivery orifice extension that can be extended from the tip of the shaft, comprising a component at the tip of the shaft along the major axis of the shaft and a second component in a direction transverse to the major axis. The device described. 6. The apparatus of claim 5, wherein the fluid delivery orifice extension is an inflatable balloon at the tip of the shaft, and the apparatus includes a plurality of fluid delivery orifices attached to the inflatable balloon.   The device of claim 1, comprising a drain tube extending from the distal end to the proximal end and capable of draining urine from the bladder when the device is installed in a patient's body.   The apparatus of claim 7, comprising a steerable shaft tip.   The apparatus of claim 1, comprising an optical instrument that allows optical communication between the proximal end and a field of view from the distal end.   The apparatus of claim 1, wherein a tip of the shaft is steerable.   The apparatus of claim 10, comprising an optical instrument that allows optical communication between the proximal end and a field of view from the distal end.   The apparatus of claim 10, wherein the fluid delivery orifice is an extensible fluid delivery tube bore extending away from the tip of the shaft. The apparatus includes a remote console coupled to the proximal end via a flexible conduit;
The console includes a pressure source and a fluid reservoir in communication with a fluid delivery orifice;
The apparatus of claim 12, wherein the pressure source can pressurize the fluid reservoir. The device can dispense fluid independently from multiple orifices;
Two fluid delivery orifices at the tip;
Two fluid reservoirs,
One fluid reservoir is in fluid communication with one fluid dispensing orifice and the other fluid reservoir is in fluid communication with the other fluid dispensing orifice;
The apparatus according to claim 1. A device according to any one of claims 1 to 14 is prepared,
Inserting the tip into the urethra, placing a fluid delivery orifice at a predetermined location in the urinary tract,
Extending the extensible fluid delivery orifice;
Including providing fluid into the urinary tract,
A method of delivering fluid to urinary tract tissue.   16. The method of claim 15, comprising injecting fluid into the tissue of the lower urinary tract.   16. The method of claim 15, comprising instilling fluid onto the surface of the lower urinary tract tissue.   The method of claim 15, wherein the tissue is selected from the group consisting of urethral tissue, prostate tissue, bladder neck tissue, bladder tissue, ureteral tissue, and kidney tissue. The proximal end,
A shaft extending from the proximal end to the distal end and including a steerable portion;
A fluid delivery orifice at the tip;
An optical instrument that enables optical communication between the proximal end and the distal end;
A device that provides fluid to the tissues of the urinary tract.   The apparatus of claim 19, comprising a plurality of fluid dispensing systems, each including a fluid reservoir and a fluid dispensing orifice. Preparing an apparatus according to claim 19 or 20,
Inserting the tip into the urethra, placing a fluid delivery orifice at a predetermined location in the urinary tract,
Observe the donation site using the optical instrument,
Steer the tip,
Including providing fluid to the urinary tract,
A method of delivering fluid to urinary tract tissue. A device that delivers fluid to the tissues of the urinary tract and can dispense two different fluids,
The proximal end,
A shaft extending from the proximal end to the distal end;
A first group of two or more fluid dispensing orifices at the tip, wherein the first group of two or more fluid dispensing orifices are in fluid communication with each other and in fluid communication with the first fluid reservoir;
A second group of two or more second fluid delivery orifices at the tip, wherein the second group of two or more second fluid delivery orifices are in fluid communication with each other and in fluid communication with a second fluid reservoir; ,
A first cover that selectively opens and closes one or more first fluid delivery orifices;
A cover that selectively opens and closes one or more second fluid delivery orifices;
A pressure source that pressurizes the fluid reservoir and can dispense fluid from a fluid dispensing orifice;
apparatus. The device includes a remote console;
The remote console is
A first fluid reservoir in fluid communication with a first group of fluid dispensing orifices;
A second fluid reservoir in fluid communication with a second group of fluid delivery orifices;
A pressure source capable of pressurizing the first fluid reservoir, the second fluid reservoir, or both, and dispensing fluid independently of the first and second fluid dispensing orifices;
The apparatus of claim 22. Providing an apparatus according to claim 22 or 23;
Inserting the tip into the urethra, placing a fluid delivery orifice at a predetermined location in the urinary tract,
Dispensing fluid through a first fluid dispensing orifice;
Dispensing different fluids through a second fluid dispensing orifice,
A method of delivering fluid to tissue.

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