Abstract:
A needle device for penetrating body tissues while substantially reducing the risk of damage to blood vessels and body organs by using visual control of the operative tip during insertion and the procedure, is disclosed herein. The needle device of the present invention has a large and diverse applicability to a number of medical procedures by enabling internal visual inspection of body tissues and cavities during treatment without open surgery or supplemental penetrating or visualization devices.

Description:
TECHNICAL FIELD  
         [0001]    The present invention generally relates to devices for percutaneous diagnostic and therapeutic procedures, and, more particularly, to a multi-lumen needle device incorporating an optical element for continuously visualizing placement of the operative tip of the device during the procedure.  
         BACKGROUND INFORMATION  
         [0002]    Percutaneous needle devices are used in a number of medical procedures, where access to body cavities or organs is desired. Such needle devices typically have a hollow shaft ending in a point, which serves to pierce the body tissue. After inserting the device to the target body cavity or organ, the hollow shaft may be used as a channel to take a fluid sample from the target site, aspirate, irrigate or deliver medicaments and other materials to the target site.  
           [0003]    Despite the use of preliminary exploratory measuring procedures such as ultrasound and X-ray, it is extremely difficult for a medical professional to determine the positional relationship of the tip of the needle to an internal organ or body cavity to be treated. Moreover, blind percutaneous insertion of the needle device entails the risk of damaging blood vessels, puncturing organs, or tearing tissue as the needle is directed toward the target.  
           [0004]    Typically, when percutaneous insertion of the treating instrument is desired, a puncture needle and a stylet are inserted in the target area without visualization of the piercing tip. Subsequently, the stylet is withdrawn and a multi-lumen endoscope or catherer are inserted. This may prolong and complicate the procedure, as well as cause inconvenience to a patient. Furthermore, as described above, initial unguided insertion of a puncture needle increases a risk of damaging blood vessels and internal organs.  
           [0005]    While it is desirable that surgical instruments have a minimum diameter, the small diameter of instruments heretofore resulted in functional limitations. To overcome this deficiency, additional viewing instruments are often inserted to the target site. Such additional instruments, however, are typically too large to be successfully used in many medical procedures involving percutaneous devices.  
           [0006]    It is, thus, desirable to provide a penetrating needle device that allows visualization of the target tissue simultaneous with application of diagnostic and treatment procedures. Thus, there is a need in the art for a low profile needle device capable of penetrating body tissues and enabling a medical professional to perform a number of diagnostic and therapeutic procedures percutaneously with a precise degree of control without resort to essentially blind approaches to the target tissue.  
         SUMMARY OF THE INVENTION  
         [0007]    It is an object of the present invention to provide a versatile diagnostic and treatment needle device useful for inspection and treatment of internal body tissues, including removing material within a body such as calculi, hydrodissection of tissue planes, tissue cutting, flushing and debridement, and percutaneous injection of bulking materials, while substantially reducing the risk of damage to blood vessels and body organs.  
           [0008]    Further, it is an object of the present invention to provide a versatile diagnostic and treatment needle device capable of percutaneous approaches to body cavities while providing continuous visual supervision of the surgical field, control of the insertion of the device, and performance of a therapeutic procedure through an operative channel of the device.  
           [0009]    Finally, it is an object of the present invention to provide a versatile diagnostic and treatment needle device which is miniature enough to be acceptable for introduction into and visualization of tissue areas, which are difficult to otherwise access without resorting to open surgery techniques or to essentially blind guidance techniques.  
           [0010]    Accordingly, a low profile needle device for penetrating body tissues while substantially reducing the risk of damage to blood vessels, nerves, and body organs by enabling the visualization and control of the operative tip during insertion and the procedure, is disclosed herein. The needle device of the present invention has a large and diverse applicability to a number of medical procedures because it enables internal visual inspection of body tissues and cavities at the treatment site without resorting to open surgery or to the simultaneous introduction or supplemental penetrating of visualization devices at the treatment site.  
           [0011]    The needle device is adapted for applying hydrodynamic spray to the inside surface of the kidney or other tissue such as peri-prostatic tissue to irrigate the surface or debride tissue therefrom, or in between body organs or tissue to dissect the tissue planes. The needle device of the present invention is also useful for efficient percutaneous injections of bulking material into the urinary bladder wall, urethral wall or tissues surrounding the bladder or urethra.  
           [0012]    The present invention enables the physician to observe the advance of the operative pointed tip of the device, thereby assisting the physician in controlling the path of the needle device and rate of its advance, as well as permits the physician to observe the tissues in front of the tip in order to avoid damage to vessels, nerves, and organs. In addition, the invention permits the physician to visualize the opening of the operative channel during the procedure. Because of its convenient size and low profile, the device of the present invention performs the above-described functions without compromising maneuverability and ease of use.  
           [0013]    In general, in one aspect, the invention features a needle device, consisting of a supply tube and a nozzle with a tissue piercing point at its distal end. The tissue-piercing point of the nozzle may be adapted to penetrate skin, rectus, bladder wall and bladder neck of a patient. In one embodiment, the tissue piercing point may be reinforced.  
           [0014]    A first lumen, axially formed in the nozzle, is connected to the distal end of the supply tube and has a first opening at the distal end of the nozzle. A second lumen axially formed in the nozzle has a second opening near the distal end of the nozzle. The second opening is positioned proximal to the tissue piercing point of the nozzle and proximal to the first opening. At least one optical element is axially positioned in the second lumen for transmitting and receiving optical radiation through the second opening in the nozzle.  
           [0015]    Embodiments of this aspect of the invention include the following features. In one embodiment, the nozzle is a hollow tubular member having a first tube and a second tube axially disposed therein defining the first lumen and the second lumen respectively. In another embodiment, the nozzle consists of a base cylindrical member and a auxiliary cylindrical member, axially extending from the base cylindrical member at the distal end of the nozzle. The first lumen is axially formed in and extends through the base cylindrical member and the auxiliary cylindrical member. The second lumen is axially formed in and extends through the base cylindrical member.  
           [0016]    In one embodiment, the needle device may also include a suction apparatus. The needle device may contain a handle at the proximal end of the nozzle. In one embodiment, the needle device may include a pressurizer for transporting fluids under pressure through the tube, the nozzle and through the first opening. The pressurizer may be pneumatic or hydraulic, for example, a bladder pump, a piston pump, and an impeller pump. In another embodiment, the pressurizer intermittently pressurizes the fluid delivered through the first opening. In yet another embodiment, the pressurizer delivers pressurized fluid through the first opening at a rate sufficient to dissect tissue planes.  
           [0017]    In one embodiment, the second opening is substantially perpendicular to the longitudinal axis of the nozzle and proximal to the distal end of the nozzle. In a particular embodiment, the auxiliary cylindrical member curves inward at its distal end so that the first opening of the first lumen of the nozzle is substantially parallel to the longitudinal axis of the nozzle and the tissue piercing point is adjacent and distal to said first opening.  
           [0018]    In one embodiment, the optical element positioned in the second lumen of the nozzle may be an image transmitting bundle of fiber-optic rods. The optical element may also include a fish-eye lens positioned at the second opening. Further, the needle device may include a plurality of illumination transmitting fiber-optics rods. In one embodiment, the illumination transmitting fiber-optics rods may be disposed in the second lumen. In another embodiment, the illumination transmitting fiber-optics rods may be positioned in the space between the hollow tubular member of the nozzle and the first and the second tubes.  
           [0019]    In one embodiment, the device further consists of a syringe for holding bulking material. Non-limiting examples of such bulking material include collagen, silicone particles, ceramic balls, and fluoropolymer particles. In use, the pressurizer transports the bulking implant material under pressure from the reservoir through the nozzle and the first opening. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]    In the drawings like reference characters generally refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.  
         [0021]    [0021]FIG. 1 illustrates a schematic view of the needle device according to one embodiment of the present invention.  
         [0022]    [0022]FIG. 2 illustrates a schematic view of the needle device according to another embodiment of the present invention.  
         [0023]    [0023]FIG. 3 illustrates a longitudinal cross-sectional view of the nozzle and its attachment to the handle according to the one embodiment of the present invention.  
         [0024]    [0024]FIG. 4 illustrates an enlarged longitudinal cross-sectional view of the distal end of the nozzle according to the embodiment the present invention shown in FIG. 3.  
         [0025]    [0025]FIG. 5 illustrates a cross-sectional view along the line  5 - 5  of FIG. 4 according to one embodiment of the present invention.  
         [0026]    [0026]FIG. 6 illustrates a cross-sectional view along the line  5 - 5  of FIG. 4 according to another embodiment of the invention.  
         [0027]    [0027]FIG. 7 illustrates a perspective view of the distal end of the nozzle according to another embodiment of the present invention.  
         [0028]    [0028]FIG. 8 illustrates an enlarged longitudinal cross-sectional view of the distal end of the nozzle according to the embodiment of the present invention shown in FIG. 7  
         [0029]    [0029]FIG. 9 illustrates a cross-sectional view along the line  9 - 9  of FIG. 8 according to another embodiment of the invention.  
         [0030]    [0030]FIG. 10A illustrates an enlarged longitudinal cross-sectional view of the distal end of the nozzle according to yet another embodiment of the present invention.  
         [0031]    [0031]FIG. 10B illustrates an enlarged longitudinal cross-sectional view of the distal end of the nozzle according to still another embodiment of the present invention.  
         [0032]    [0032]FIG. 11 illustrates a top view of the distal end of the nozzle according to the embodiments of the present invention shown in FIGS. 10A and 10B.  
         [0033]    [0033]FIG. 12A illustrates positioning of the nozzle in a method for removing calculi from a kidney using the needle device of the present invention.  
         [0034]    [0034]FIG. 12B illustrates positioning of the nozzle in a method for injecting bulking material using the needle device of the present invention  
         [0035]    [0035]FIG. 13 illustrates positioning of the nozzle in a method for separating tissue planes using the needle device of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0036]    A feature common to each of the embodiments of the needle device according to the invention described below is a multi-lumen nozzle with a tissue-piercing point. At least one lumen in the nozzle is a working channel, for example, for aspiration, flushing or introduction of a surgical instrument. At least one other lumen has an optical system. The optical system is positioned in the nozzle to enable an operator to view the tissue piercing point during a surgical procedure.  
         [0037]    Referring to FIG. 1, a needle device  10  includes a multi-lumen nozzle  30  connected to a reservoir  60  by a supply tube  40 . The reservoir  60  supplies fluid  100  under pressure through the supply tube  40  to the nozzle  30 , which directs the pressurized fluid  100  onto a target body site in the patient. In one embodiment of the present invention, the needle device  10  also includes a suction apparatus  70  connected to the nozzle  30 , for example, through the supply tube  40  to enable aspiration through the nozzle  30 . In this embodiment of the invention the supply tube  40  may have two lumens  42  and  44  where one lumen  42  is used for flushing, and the other lumen  44  for aspiration of the target body site.  
         [0038]    In one embodiment, according to the invention, the reservoir  60  contains fluid  100 , for example, water, Ringer&#39;s solution, or a balanced salt solution such as saline solution. The fluid  100  may contain medications  105 , for example, antibiotics. In one embodiment, medications  105  are added to the reservoir  60 . In another embodiment, the needle device  10  includes a container  46  with medications  105  connected to the nozzle  30  through the supply tube  40 . In this embodiment, medications  105  are supplied to the flow of the fluid  100  in the lumen  42  of the supply tube  40  from the container  46 . In another embodiment, the fluid  100  contains bulking material such as collagen, silicone particles, ceramic balls, or fluoropolymer particles, for example, polytetrafluoroethylene particles sold under the trademark TEFLON® by E.I. du Pont de Nemours and Company of Wilmington, Del.  
         [0039]    Referring still to FIG. 1, in another embodiment of the needle device  10  according to the invention, a pressurizer  65  is submerged in the reservoir  60 . The pressurizer  65  transfers fluid  100  from the reservoir  60  under pressure and delivers fluid  100  to the nozzle  30  through the lumen  42  in the supply tube  40 . In one embodiment of the invention, the pressurizer  65  is an electric multi-stage rotary hydraulic pump, for example, a bladder pump, piston pump, or impeller pump. Other hydraulic pumps known in the art can also be used. In another embodiment, the pressurizer  65  is a pneumatic pump. In yet another embodiment, the reservoir  60  is pressurized by a pressurizer external to the reservoir  60 . In yet another embodiment of the invention, the reservoir  60  is an intravenous fluid bag. Pressure may be applied to the intravenous fluid bag manually, by gravity, a pressure cuff, or by means of a pressurized chamber. In still another embodiment, a gas, for example, oxygen, carbon dioxide, or nitrogen, may be used in place of fluid  100 .  
         [0040]    With continued reference to FIG. 1, in one embodiment of the invention, the pressurizer  65  may include a pulsatile flow generator  67  to intermittently change the pressure of the flow of fluid  100  delivered to the nozzle  30 . Suitable pulsatile flow generators may include, but are not limited to, for example, an ultrasonic vibrator, valving system, gas-assist system, and piezoelectric actuator. In one embodiment, the pulsatile flow generator  67  is flutter valve, activated by the fluid flow that rhythmically opens and closes to intermittently change the pressure of the flow of fluid  100 .  
         [0041]    Referring still to FIG. 1, in one embodiment, a handle  50  having a lumen  51  therein is attached to the supply tube  40  to enable manipulation of the nozzle  30  inside the patient&#39;s body. A proximal end  315  of the nozzle  30  is in fluid communication with at least one lumen  42  of the supply tube  40 . The handle  50  may also contain or be connected to a control system (not shown) to control the pressurizer  65 , pulsatile flow generator  67  and suction apparatus  70  to manage the pressure and direction of fluid  100 , as well as pulsation and aeration of the flow. The control system of the handle  50  may also permit switching between flushing and aspiration modes.  
         [0042]    As illustrated in FIG. 1, the handle  50  includes a port  55  for introducing optical elements. Attached to the port  55  are a light source  57  and an ocular system  59 . Suitable light sources may include, but are not limited to, for example, a high-intensity tungsten filament lamp with fan cooling, or a halogen lamp. The light source  57  is in optical communication with a distal end  316  of the nozzle  30  through illumination fiber-optics rods, to be described below, axially positioned in a connecting tube  570 , the lumen  51  in the handle  50 , and the nozzle  30 . The light source  57  provides illumination to the target site inside the patient&#39;s body. The ocular system  59 , which includes an objective  592  and a focusing system  593 , is in optical communication with the distal end  316  of the nozzle  30  through the image-transmitting fiber-optics bundle, to be described below, in a connecting tube  590 , the lumen  51  in the handle  50 , and the nozzle  30 . The ocular system  59  permits an operator to visualize the distal end  316  of the nozzle  30  when the nozzle  30  is positioned inside the patient&#39;s body during a surgical procedure as will later be described.  
         [0043]    Referring to FIG. 2, in another embodiment of the invention, a needle device  10 , according to the invention, includes a syringe  80  containing fluid  100 . In one embodiment, the syringe  80  is affixed to the handle  50  through a port  75  having a lumen  77 , such as a Luer port. The barrel of the syringe  80  is in fluid communication with the lumen  51  in the handle  50  and the nozzle  30 . In one embodiment of the invention, the fluid  100  is preferably a bulking material to be injected, for example, into the submucosal tissues of the urethra and/or the bladder neck and into tissues adjacent to the urethra for treatment of, for example, intrinsic sphincter deficiency. In this embodiment of the invention, a control system of the handle  50  includes a flow control subsystem, for example, a three-way valve (not shown), which allows the operator to switch between reservoir  60  and syringe  80  as sources of fluid  100 .  
         [0044]    In another embodiment of the invention, referring to FIG. 3, the nozzle  30  has a proximal end  315 , which is secured to the handle  50 , for example, by means of a mounting member  52  disposed in the distal end  53  of the handle  50 . In one embodiment, the nozzle  30  has a hollow tubular member  33 . The tubular member  33  is formed from, for example, a stainless steel tube, having an outside diameter from 0.050 to 0.275 inches, preferably 0.100 inches, an inside diameter from 0.033 to 0.175 inches, preferably 0.085 inches, and a wall thickness from 0.0035 to 0.010 inches, preferably 0.006 inches. The nozzle  30  has a bevel  312  ranging from 0° to 45° angle α from the plane of the longitudinal axis  300  of the nozzle  30 . The bevel  312  forms a tissue piercing point  310  at the distal end  316  of the nozzle  30 . The tissue piercing point  310  is adapted to penetrate body tissues, including skin, rectus, bladder wall and bladder neck. In one embodiment of the invention, the tissue piercing point  310  is reinforced by, for example, a cobalt-chromium alloy to improve, for example, edge holding, durability and strength of the tissue piercing point  310 .  
         [0045]    Referring still to FIG. 3, in one embodiment according to the invention, disposed within the nozzle  30  are the second tube  329  defining an axially disposed second lumen  330 , and an operative channel comprising a first tube  319  defining an axially disposed first lumen  320 . In the preferred embodiment, the first tube  319  and the second tube  329  are substantially parallel and substantially adjacent to each other. The second tube  329  is made of any suitable material, for example, stainless steel or polyimide, and has an outside diameter from 0.020 to 0.100 inches, preferably 0.050 inches, an inside diameter from 0.015 to 0.090 inches, preferably 0.040 inches, and a wall thickness from 0.003 to 0.010 inches, preferably 0.005 inches. The first tube  319  is also made from any suitable material, for example, stainless steel or polymide, and has an outside diameter of from 0.050 to 0.150 inches, preferably 0.100 inches, an inside diameter from 0.040 to 0.140 inches, preferably 0.090 inches, and a wall thickness from 0.002 to 0.010 inches, preferably 0.005 inches. The first tube  319  and the second tube  329  extend proximal to the proximal end  315  of the nozzle to a connector  54  in the distal end of the handle  50  as will be described below. In another embodiment, the first lumen  320  and the second lumen  330  may be formed as an integral part of the nozzle, for example, by an extrusion process.  
         [0046]    Referring to FIG. 4, the first lumen  320  of the first tube  319  has a first opening  340  at the distal end  316  of the nozzle  30  substantially adjacent to the tissue piercing point  310 . The second lumen  330  has a second opening  350  proximal to the tissue piercing point  310  and proximal to the first opening  340  so that the first opening  340  is positioned distal to the second opening  350  and the tissue piercing point  310 . The openings  340  and  350  are disposed in the bevel  312  at the distal end  316  of the nozzle  30 .  
         [0047]    Referring still to FIG. 4, a lens system  360  is joined to the distal end of the tube  329  at the second opening  350 . In a particular embodiment, the lens system  360  includes a wide-angle plano-convex lens, also known as a “fish-eye” lens, made from any suitable material, such as glass having, for example, a glass index of 1.62.  
         [0048]    Referring still to FIG. 4, in one embodiment, an image transmitting bundle  370  of fiber-optic rods or fibers is disposed within the second lumen  330 . In order to provide a high quality resolution for viewed objects, the smallest flexible fiber-optic fibers available in the making of the bundle  370  are used. Such bundles are usually produced by a drawing technique where a bundle of fibers is heated and the fibers are drawn at a specific drawing pressure and rate so that the bundle is elongated and the diameter of the fibers is reduced to achieve a predetermined diameter. In a particular embodiment, each of the individual fibers of the bundle  370  is approximately 6 microns in diameter. The preferred diameter of individual fiber rods in the bundle  370  is in the range from approximately 4 microns to about 10 microns. Additionally, the fibers in the bundle  370  can be made from any suitable material, including glass or plastic. The diameter of the fiber-optic bundle  370  is in the range from about 200 microns to 600 microns, preferably from about 300 microns to 500 microns. For descriptive purposes in this application, the term “rods” is used to define optic fibers of the type referred to herein, for example, flexible optic fibers.  
         [0049]    Further, referring now to FIG. 5, a cross-section of an embodiment of the nozzle  30 , illustrated in FIG. 4, is shown. A plurality of illumination transmitting fiber-optic rods or fibers  380  is axially disposed in the nozzle  30 . There are typically about 6,000 fiber-optic rods in the fiber-optic bundle. In a particular embodiment, the rods  380  are positioned within the second lumen  330  and extend from the second opening  350  of the nozzle  30  to the light source  57  (shown in FIGS.  1 - 2 ). In one embodiment of the invention, the nominal diameter of the bundle  370  is 375 microns. In another embodiment, the rods  380  having diameters ranging from 0.003 to 0.008 inch are bundled in a plurality of bundles  370  having diameters ranging from 0.020 to 0.030 inches.  
         [0050]    Referring now to FIG. 6, another embodiment of the illumination transmitting fiber-optic rods  380  is illustrated. A plurality of rods  380  is axially disposed within the nozzle  30  outside of and parallel to the lumens  320  and  330  of the tubes  319  and  329  respectively. The rods  380  extend from the distal end  316  of the nozzle  30  to the light source  57  (shown in FIGS.  1 - 2 ).  
         [0051]    Referring again to FIG. 3, the fiber-optic bundle  370  and the plurality of rods  380  exit from the proximal end  315  of the nozzle  30  into the connector  54  and then into the port  55  through the connecting tubes  570  and  590 . The proximal ends of the rods  380  pass through port  55  and are in optical communication with the light source  57  shown on FIGS.  1 - 2 . Light is transmitted from the light source  57  through the distal end  316  of the nozzle  30  onto the target body site. The proximal end of the fiber optic bundle  370  is in optical communication with the ocular system  59  shown in FIGS.  1 - 2  to permit visualization of an image, such as a composite image, transmitted by the lens system  360  to the proximal end of the bundle  370 . In order that the image transmitted by the lens system  360  is precisely focused on the proximal end of the bundle  370 , the bundle  370  can be reciprocated axially within the lumen  330  to compensate for objects viewed at varying distances from the second opening  350  of the nozzle  30 .  
         [0052]    Referring to FIG. 4, in one embodiment of the invention, the first opening  340  is positioned distal to the second opening  350  between the second opening  350  and the tissue piercing point  310 . Such configuration of the tissue piercing point  310 , and the opening  350  enables an operator to observe the tissue piercing point  310  as it advances in the patient&#39;s body, as well as to observe the first opening  340 .  
         [0053]    Referring again to FIGS.  1 - 2 , the fluid  100  may be held in the reservoir  60  or the syringe  80 . Referring again to FIG. 3, in one embodiment, the lumen  320  of the nozzle  30  is in fluid communication with the reservoir  60  shown in FIG. 1 through the supply tube  40  and the connector  54  in the handle  50 . In another embodiment, the lumen  320  of the nozzle  30  is in fluid communication with the syringe  80 , through a connecting tube  810 , axially disposed in the lumen  77  of the port  75 , and the connector  54 . In one embodiment, the connector  54  contains a flow control system (not shown), which allows an operator to connect the first lumen  320  alternatively to the supply tube  40  or to the syringe  80  as needed.  
         [0054]    Referring to FIG. 7, in another embodiment of the needle device  10  according to the present invention, the nozzle  30  consists of a base member  31 , such as a cylindrical member, having a base longitudinal axis  735  axially disposed through the center of the base member  31 , a proximal end  733  and a distal end face  731 ; and an auxiliary cylindrical member  32 , having an auxiliary longitudinal axis  736  axially disposed through the center of the auxiliary member  32 , a proximal end  734  and a distal end face  732 . The diameter of the base cylindrical member  31  is in the range from about 0.050 inches to 0.275 inches, preferably from about 0.100 inches to 0.120 inches. The diameter of the auxiliary cylindrical member  32  in the range from about 0.050 inches to 0.090 inches, preferably from about 0.060 inches to 0.080 inches. The auxiliary cylindrical member  32  extends axially from the distal end face  731  of the base cylindrical member  31 . The length of the auxiliary cylindrical member  32  is in the range from about 0 inches to 0.100 inches, preferably from about 0.125 inches to 0.500 inches. In one embodiment of the nozzle  30 , the center auxiliary axis  736  is substantially parallel to and offset from the central base axis  735 .  
         [0055]    Referring still to FIG. 7, in a particular embodiment, the distal end face  731  of the base cylindrical member  31  is substantially perpendicular to the central base axis  735 . The distal end face  732  of the auxiliary cylindrical member  32  is positioned at an angle β between 0° and 90° clockwise from the auxiliary axis  736 , preferably between 15° and 30°, thereby forming a tissue piercing point  310  at the distal end  316  of the nozzle  30 .  
         [0056]    The tissue piercing point  310  is adapted to penetrate body tissues, including skin, rectus, bladder wall and bladder neck. In one embodiment of the invention, the tissue piercing point  310  is reinforced to improve, for example, edge holding, durability and strength of the tissue piercing point  310 .  
         [0057]    With continued reference to FIG. 7, the first lumen  320  and the second lumen  330  are disposed axially in the nozzle  30 . The first lumen  320  extends from the proximal end  733  of the base cylindrical member  31  to the distal end face  732  of the auxiliary cylindrical member  32 . The second lumen  330  extends from the proximal end  733  of the base cylindrical member  31  to the distal end face  731  of the base cylindrical member  31 . In a particular embodiment, the first lumen  320  and the second lumen  330  are substantially parallel to the central base axis  735  and to the auxiliary axis  736  of the nozzle  30 . As described above in the embodiment of the needle device depicted in FIG. 1 and FIG. 3, the lumen  320  of the nozzle  30  illustrated in FIG. 7 is in fluid communication with the reservoir  60  through the supply tube  40  and the connector  54  in the handle  50 . In another embodiment, the lumen  320  of the nozzle  30  illustrated in FIG. 7 is in fluid communication with the syringe  80  shown in FIG. 2 and described in the corresponding text, through a connecting tube  810 , axially disposed in the port  75 , and the connector  54 .  
         [0058]    Referring now to FIGS. 7 and 8, in this embodiment of the invention, the first lumen  320  has a first opening  340  in the distal end face  732  of the auxiliary cylindrical member  32  proximal and adjacent to the tissue piercing point  310 . The second lumen  330  has a second opening  350  at the distal end face  731  of the base cylindrical member  31  and adjacent to the proximal end  734  of the auxiliary cylindrical member  32 . In one embodiment of the invention, the second opening  350  is substantially perpendicular to the central base axis  735  of the base cylindrical member  31  of the nozzle  30 .  
         [0059]    As described above in the embodiment of the needle device depicted in FIG. 3 and  4 , the plurality of illumination-transmitting rods  380  and the image transmitting fiber-optic bundle  370 , having an axis  376  axially disposed through the center thereof, are disposed within the second lumen  330 . In a particular embodiment illustrated in FIGS. 7 and 8, the tissue piercing point  310  lies in the cross-sectional plane of the nozzle  30 , defined by the central base axis  735  of the base cylindrical member  31  and the auxiliary axis  736  of the auxiliary member  32 , and is positioned in that plane between the auxiliary axis  736  and the axis  376 .  
         [0060]    Referring to FIG. 8, the lens system  360  is joined to the distal end face  731  of the base cylindrical member  31  at the second opening  350 . As described above, the lens system  360  includes, for example, a wide-angle plano-convex lens made from any suitable material, such as glass.  
         [0061]    Referring to FIG. 9, the image transmitting bundle  370  of fiber-optic fibers and a plurality of illumination transmitting fiber-optic fibers  380  are disposed within the second lumen  330 . As described above with regard to the embodiment illustrated in FIGS.  3 - 5 , the image transmitting fiber-optic bundle  370  and illumination transmitting fiber-optic fibers  380  are connected to the light source  57  and the ocular system  59  shown in FIG. 1, respectively, to enable visualization of the tissue piercing point  310  through the ocular system  59 .  
         [0062]    Referring to FIG. 10 a,  in yet another embodiment of the nozzle  30  according to the invention, a distal end portion  180  of the auxiliary cylindrical member  32  forms a curve with the convex surface of the curve disposed on the side of the auxiliary cylindrical member  32  furthest from the central base axis  735 . The distal end face  732  of the auxiliary cylindrical member  32  and the first opening  340  are substantially parallel to the center base axis  735  of the nozzle  30 . The tissue piercing point  310  is located at the distal end of the distal end face  732  of the auxiliary cylindrical member  32 . In the embodiment illustrated in FIG. 10 a,  the second opening  350  is substantially perpendicular to the center base axis  735  of the base cylindrical member  31  of the nozzle  30  and substantially perpendicular to the first opening  340 .  
         [0063]    As illustrated in FIG. 10B, in another embodiment of the invention, the distal end face  732  may be positioned at an angle γ to a perpendicular  738  from the center base axis  735  drawn from the tissue piercing point  310  between 0° and 90°. In one embodiment, the angle γ equals 90°. In another embodiment, the angle y equals 60°. In yet another embodiment, the angle γ equals 45°.  
         [0064]    Referring to FIG. 11, in the embodiments of the nozzle  30  described above and illustrated in FIGS. 10 a  and  10   b  , the position of the lens  360  relative to the tissue piercing point  310  and the first opening  340  permits an operator to observe both the tissue piercing point  310  as it advances in the patient&#39;s body, and the first opening  340 .  
         [0065]    The needle device  10  of the present invention can be useful in a variety of medical procedures. For example, staghorn calculi trapped in the renal pelvis of a patient may become infected and may reform if all remnants of the stone are not removed during surgery. It is desirable to flush the renal pelvis to remove all of the stone fragments.  
         [0066]    Referring now to FIG. 12A, in another aspect the invention includes a method for removing material from the body, for example, for removing calculi  1220  from a kidney  1200 . In one embodiment of the invention, the method includes the steps of providing the needle device  10  described above with the nozzle  30  dimensioned to fit within a renal calyx  1210 . The nozzle  30  of the needle device  10  is inserted by an operator through a flank incision into the abdomen, and then into the renal pelvis  1205  of the kidney  1200  of a patient. The distal end of the nozzle  30  is visualized through the ocular system  59 . After the needle device  10  is inserted into the renal pelvis  1205 , the operator visualizes the renal calyx  1210  and advances the distal end  316  of the nozzle  30  in close proximity to the calculi  1220  in the renal calyx  1210 . The operator activates the pressurizer  65 , which transports fluid  100  from reservoir  60  under pressure through the supply tube  40  and the lumen  320 , and directs the pressurized fluid  100  through the first opening  340  onto the calculi  1220 . The calculi  1220  are flushed from the renal calyx  1210  into the renal pelvis  1205  where the calculi  1220  are aspirated or pass freely from the kidney  1200  to the urethra  1230 , and out of the patient&#39;s body.  
         [0067]    In another embodiment, the needle device  10  can be used to treat intrinsic sphincter deficiency (“ISD”), which is a medical condition that is characterized by stress incontinence and has been associated with a weak urethral sphincter that is unable at rest to adequately close the urethra. Treatment of this condition typically entails injection of a bulking material, such as, for example, collagen, silicone particles, ceramic balls, or fluoropolymer particles, for example, polytetrafluoroethylene particles sold under the trademark TEFLON® by E. I. du Pont de Nemours and Company of Wilmington, Del., to obstruct the lumen of the urethra to prevent urine outflow.  
         [0068]    Referring to FIG. 12B, the method for injecting a bulking material  110  includes providing a needle device  10  having a syringe  80  containing the bulking material  110 . The operator inserts the tissue piercing point  310  of the nozzle  30  using handle  50  through a flank incision into the abdomen of a patient, and then into the bladder  1260 , while visualizing the distal end  316  of the nozzle  30  through the ocular system  59 . After the needle device  10  is inserted into the bladder  1260 , the operator locates the bladder neck  1270  visually and inserts the tissue piercing point  310  at the distal end  316  of the nozzle  30  through the wall of the bladder neck  1270  until the tissue piercing point  310  is in the submucosal tissues as determined visually via optical system  59 . The operator activates the syringe  80  containing bulking material  110 , and injects bulking material  110  from the barrel of the syringe  80  through the connecting tube  810 , into the lumen  320  of the nozzle  30 , and through the first opening  340  near the tissue piercing point  310  into the submucosal tissues of the urethra, the bladder neck, and/or into peri-urethral tissues proximal to the urethra. Bulking material  110  is injected into the tissue until the operator determines visually that the urethral sphincter muscle is coapted and able to maintain sufficient resting closing pressure to prevent urine from involuntarily leaking from the distal urethral orifice of the patient.  
         [0069]    It can be appreciated that this method of the invention is not limited to the embodiments described above and shown in FIGS.  12 A- 12 B. The method according to the invention can also be applied to other internal surfaces in the body to flush, irrigate, cut, or debride tissue, such as diverticular or fistular tissue, or to inject fluids into tissues in the patient&#39;s body.  
         [0070]    The needle device of the present invention can also be used in the course of retropubic radical laparoscopic prostatectomy, a standard surgical procedure for patients with organ confined prostate cancer. During this procedure, it is highly desirable to maintain the neuro-vascular bundle of the prostate intact to preserve sexual function. The nerve sparing technique is difficult because this bundle is located under the prostate and out of the field of vision of the laparoscope. Referring to FIG. 13, in one embodiment of the invention, the method for hydrodissecting tissue planes, more particularly, for example, for separating the prostate  1310  from the ventral surface of the rectum  1320 , includes the steps of providing the needle device  10  described herein, inserting the nozzle  30  using the handle  50  until the tissue piercing point  310  is in the biplane fascial layer  1330 , known as Denonvillers fascia and located between the dorsal surface of the prostate  1310  and the ventral surface of the rectum  1320 , and, as described above, injecting a fluid or a gas at a sufficient force into Denonvillers fascia to generate a fluid-filled or gas-filled space  1340  to physically separate the prostate  1310  and the rectum  1320 . This method can be practiced by a variety of surgical approaches, such as, for example, transperineally, transrectally, or suprapubically, and avoids substantially traumatizing the prostate neurovascular bundle  
         [0071]    It can be appreciated that the method of hydrodissecting is not limited to separating the prostate from the rectum, and may also be used separate muscle planes or to hydrodissect other tissue planes in the body, such as strictures or adhesions.  
         [0072]    It will be apparent to those skilled in the art of medical devices that various modifications and variations can be made to the above-described structure and methodology without departing from the scope or spirit of the invention.