Abstract:
An apparatus cooperable with a grasping slot of an elevator for an endoscope is disclosed. The apparatus comprises an outer catheter including an inner lumen and an outer surface having a radial groove formed thereabout. The radial groove is cooperable with the grasping slot to inhibit longitudinal movement of the catheter with respect to the elevator. The apparatus further comprises an elongate member disposed through the inner lumen of the catheter.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Application Ser. No. 60/779,036, filed on Mar. 3, 2006, entitled “ENDOSCOPIC DELIVERY APPARATUS HAVING A CATHETER WITH RADIAL GROOVES,” the entire contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to medical devices, and more particularly, to endoscopic delivery apparatus.  
       BACKGROUND OF THE INVENTION  
       [0003]     Endoscopic devices have been commonly used for various procedures, typically in the abdominal area. Endoscopy is the examination and inspection of the interior of body organs, joints or cavities through an endoscope. Endoscopy allows physicians to peer through the body&#39;s passageways. An endoscopic procedure may be used to diagnose various conditions by close examination of internal organ and body structures and may also guide therapy and repair, such as the removal of torn cartilage from the bearing surfaces of a joint. A biopsy, a procedure involving tissue sampling for pathologic testing, may also be performed under endoscopic guidance. For example, endoscopic procedures include the following known procedures: gastroscopy, sigmoidoscopy and colonoscopy, esophago gastro duodenoscopy (EGD), endoscopic retrograde cholangiopancreatography (ERCP), and bronchoscopy.  
         [0004]     The use of endoscopic treatments has recently increased for some diseases occurring in the gastrointestinal or pancreatobiliary duct systems. Endoscope systems are used frequently for diagnostic procedures, including contrast imaging of biliary or pancreatic ducts. Endoscopes are also used in procedures for retrieving gallstones that exist in the common bile duct and elsewhere.  
         [0005]     Typically, these treatments are performed in the pancreatic duct, bile duct, and the hepatic duct by positioning the distal end of an endoscope in the vicinity of the duodenal papilla. Once the endoscope is in place, a wire guide is delivered to the target anatomy via the working channel of the endoscope. In order to guide the wire guide (or other medical instruments) out of the working channel of the endoscope, a rigid elevator is typically used to orient or deflect the distal end of the wire guide. When the distal end of the wire guide is properly oriented, the wire guide is inserted into the target anatomy.  
         [0006]     At this point in the procedure, a catheter or similar treatment instrument can be passed over the wire guide either in a conventional over-the-wire style or in a rapid exchange style to the target anatomy. In order to limit movement of the wire guide relative to the target anatomy, the distal or proximal ends of the guide wire can be locked relative to the endoscope.  
         [0007]     Many current endoscopic systems include endoscopes having an elevator used to orient the wire guide and to lock the distal end of the wire guide. In many of such endoscopes, the elevator includes a v-shaped groove. The v-shaped groove is typically used to guide the wire guide to a central position relative to the endoscope. The elevator having a v-shaped groove is further used to lock the distal end of the guide wire.  
         [0008]     Thus, there is a need to hold or maintain a delivery device, such as a catheter, within an endoscope so that another device such as a stent may be delivered to a target location in a patient anatomy.  
       BRIEF SUMMARY OF THE INVENTION  
       [0009]     The present invention generally provides an endoscopic assembly and an endoscopic delivery apparatus that solve the challenges mentioned above. The present invention provides a way of holding or maintaining a delivery apparatus in a relatively fixed position so that a medical device, such as a stent, may be delivered to a target location in a patient anatomy. Embodiments of the present invention provide for a way to rest or seat a delivery apparatus on an elevator of an endoscope during deployment of a medical device without compromising time effectiveness.  
         [0010]     In one embodiment, the present invention provides an apparatus cooperable with a grasping slot of an elevator for an endoscope. The apparatus comprises an outer catheter including an inner lumen and an outer surface having a radial groove formed thereabout. The radial groove is cooperable with the grasping slot to inhibit longitudinal movement of the catheter with respect to the elevator. The apparatus further comprises an elongate member disposed through the inner lumen of the catheter.  
         [0011]     In another embodiment, the present invention provides an endoscopic system. The system comprises an insertion tube extending to a distal tip and including an elevator movably attached thereto. The elevator has an inner side formed thereon defining a grasping slot. The system further comprises an outer catheter including an inner lumen and an outer surface having a radial groove formed thereabout. The radial groove is cooperable with the grasping slot to inhibit longitudinal movement of the catheter with respect to the elevator. The system further comprises an elongate member disposed through the inner lumen of the catheter.  
         [0012]     In another example, the present invention provides a method of engaging an apparatus cooperable with an elevator of an endoscope. The method comprises inserting a catheter in a patient anatomy. The catheter includes an inner lumen and an outer surface having a radial groove formed thereabout. The radial groove is cooperable with the grasping slot. The method further comprises positioning the outer catheter within a target location in the patient anatomy and engaging the radial groove with the elevator to inhibit longitudinal movement of the catheter with respect to the elevator.  
         [0013]     Further objects, features, and advantages of the present invention will become apparent from consideration of the following description and the appended claims when taken in connection with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]      FIG. 1   a  is a perspective view of an endoscopic system comprising an endoscope in accordance with one embodiment of the present invention;  
         [0015]      FIG. 1   b  is a perspective view of the endoscope depicted in  FIG. 1A ;  
         [0016]      FIG. 1   c  is an elevated view of a distal tip of the endoscope in accordance with one embodiment of the present invention;  
         [0017]      FIG. 2  is an enlarged view of the distal tip of the endoscope in accordance with one embodiment of the present invention;  
         [0018]      FIG. 3  is a cross-sectional view of the distal tip of the endoscope insertion portion of the endoscope taken along line  3 - 3 ;  
         [0019]      FIG. 4  is a side view of an elevator in accordance with one embodiment of the present invention;  
         [0020]      FIG. 5  is a side view of a delivery apparatus in accordance with one embodiment of the present invention;  
         [0021]      FIG. 6  is a schematic view of the delivery apparatus in accordance with one embodiment of the present invention; and  
         [0022]      FIG. 7  is a perspective view of the delivery apparatus cooperable with an elevator of an endoscope. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     The present invention generally provides an endoscopic delivery apparatus and an endoscopic assembly having features that allow the delivery apparatus to be held or maintained in a particular longitudinal position so that a medical device (such as a stent or coil) may be delivered to a target location in a patient anatomy. Embodiments of the present invention allow a practioner to focus on movement of a stent or other device to be deployed at the target location without relative concern of variable movement of the delivery apparatus. In one embodiment, the endoscopic delivery apparatus comprises an outer catheter having a plurality of grooves formed thereon. The grooves cooperate with an elevator of the endoscope so that the outer catheter may be seated or held in a longitudinal position relative to the endoscope, thereby allowing a medical device to be deployed to a target location in a patient anatomy.  
         [0024]      FIGS. 1-3  illustrate an endoscopic system comprising an endoscope having an elevator with a distal tip. In one example, this system represents a modification to the Olympus V-Scope™. Additional details relating to the endoscopic system discussed herein are described in U.S. Pat. No. 6,827,683, entitled “ENDOSCOPE SYSTEM AND MEDICAL TREATMENT METHOD” issued Dec. 7, 2004 to Takashi Otawara, which is incorporated herein by reference in its entirety.  
         [0025]      FIG. 1   a  illustrates an endoscopic system  10  comprising an endoscope  11  in accordance with one embodiment of the present invention. In this embodiment, the endoscope  11  comprises an insertion tube  12  to be inserted into a body cavity for various endoscopic procedures including gastroscopy, sigmoidoscopy and colonoscopy, esophago gastro duodenoscopy (EGD), endoscopic retrograde cholangiopancreatography (ERCP), and bronchoscopy. The insertion tube  12  has an accessory port through which endoscopic units may be disposed. In one embodiment, endoscopic units disposed in one of the accessory ports may include one embodiment of an improved elevator having a distal tip.  
         [0026]     As shown in  FIGS. 1   a  and  1   b,  the endoscope  11  further includes a control system  14  that is in mechanical and fluid communication with the insertion tube  12 . The control system  14  is configured to control the insertion tube  12  and endoscopic parts disposed therein. As shown, the control system  14  includes first and second control knobs  16 ,  18 . The control knobs  16 ,  18  are configured to be in mechanical communication with the insertion tube  12 . The control knobs  16 ,  18  allow the physician to control and guide, by known means, the insertion tube  12  through vessels and cavities of a patient. The control system  14  further includes valve switches (e.g., suction valve  20 , air/water valve  21 , camera valve  22 ), each of which are in communication with one of the channel ports  93  of the insertion tube  12 . For example, the suction valve switch  20 , when activated, allows a vacuum from a suction source through a suction channel port for suctioning unwanted plaque and debris from the patient. Insertion of the insertion tube  12  may be rectally or orally depending on the endoscopic procedure. In one example, the distal end of the insertion tube  12  is inserted, rectally or orally, to a predetermined endoscopic location within a patient. The endoscope in combination with the elevator having the distal tip reduce the risk of tearing or scraping of the wire guide.  
         [0027]     In this embodiment, the insertion tube  12  comprises an operating portion  25  connected to the control system  14  and extending to an insertion protecting member  26 . A control system  14  is connected to the operating portion  25  and is configured to control the insertion tube  12 . In this embodiment, the insertion tube  12  is composed of components that include a flexible tube  28 , a flexure  29  connected to the flexible tube  28 , and an endoscope tip  30  connect to the flexure  29 . A universal cord  31 , on one end, is connected and in communication with the control system  14 . On the other end, the cord  31  has a connector  18  attached thereto. The connector  18  is in communication to a light guide tube and electrical contact, and is connected to a light source apparatus  32  and an image processing apparatus  33  (external devices). These external devices may include a monitor  34 , an input keyboard  35 , a suction pump apparatus  36 , an irrigation bottle  37 , and other suitable apparatus that are installed on a rack  39  equipped with rollers  38 .  
         [0028]     As shown in  FIGS. 1   c  and  2 , a concave, depressed cutout  40  is formed on the outer circumferential surface of the tip  30 . In this embodiment, a channel opening  42  is formed on one side of the cutout  40 , and an objective lens  44  and a light source  46  are disposed on another side of the cutout  40  for imaging. Both the objective lens  44  and the light source  46  are positioned adjacent to the channel opening  42 . The tip  30  further comprises a nozzle  48  extending from a back wall surface  50  of the cutout  40 . The nozzle  48  allows a stream of water, air, or the like to be sprayed towards the outer surface of the objective lens  44  to clean the lens surface.  
         [0029]      FIG. 3  further illustrates the elevator  43  comprising a grasping slot  91  in accordance with one embodiment of the present invention. The grasping slot may take on any suitable shape or form for grasping of a medical device. In this embodiment, the grasping slot  91  is narrowly formed by inner sides that define the grasping slot  91  formed through the elevator  43 . Preferably, the grasping slot  91  is centrally formed through the elevator  43  for receiving a medical device (e.g., an inner catheter or wire guide) and grasping the device during operation of the endoscope.  
         [0030]     As depicted in  FIG. 2 , system  10  further includes an outer catheter  112  disposed through the insertion tube  12  and a wire guide  56  disposed through the catheter  112 . The elevator  43  is configured to receive the catheter  112  and/or wire guide  56  for elevating the catheter  112  or wire guide  56 . As will be described in greater detail below, the delivery apparatus of the present invention has radial notches or grooves formed on the outer surface of the catheter to hold or maintain the catheter in a relatively fixed longitudinal position while other components may be moved relative thereto. For example, as the catheter is held in the grasping slot of the elevator, the wire guide or inner catheter may be withdrawn to deploy a stent or a coil to a target location in the patient anatomy.  
         [0031]     The elevator  43  is pivotally attached to the tip  30  and is configured to receive the medical instrument (e.g., catheter or wire guide) for elevating the medical instrument. As shown in  FIGS. 2-4 , the distal tip houses the elevator  43  in channel opening  42 . The elevator  43  is used to orient medical instruments such as a catheter. As discussed in greater detail below, this is accomplished by engaging the medical instrument and pivoting away from the distal tip thereby laterally moving the distal end of the medical instrument away from the distal tip. The elevator  43  thus secures the distal end of the medical instrument relative to the endoscope. That is, as the medical instrument is received in slot  91  of the elevator  43 , the medical instrument laterally moves relative to the tip  30  when the elevator  43  pivots therefrom.  
         [0032]      FIG. 3  illustrates that the endoscope tip  30  includes a cuff  60  as the main body of the tip  30 , and a sleeve or cover  62  that covers the perimeter of the cuff  60 . As shown, the cover  62  is formed using a nonconductive member such as any suitable polymeric material, e.g., polytetrafluoroethylene, polyethylene, polypropylene, perfluoroelastomer, fluoroelastomer, nitrile, neoprene, polyurethane, silicone, styrene-butadiene, rubber, and polyisobutylene. In this embodiment, the cover  62  is attached to the cuff  60  by any suitable means, e.g., by adhesive bonding. The cuff  60  is disposed adjacent the working channel  63 , which acts as a passageway for the insertion of the medical instrument, e.g., wire guide or catheter. In this embodiment, a channel  67  ( FIG. 1   c ) is formed through the tip  30  such that the tip opening of the treatment instrument is able to be disposed through channel opening  42 .  
         [0033]      FIG. 3  further illustrates an elevator wire  90  connected to the elevator  43 . In this embodiment, the elevator wire  90  is located at the operating portion  25  and extends through a guide tube  92  and a guide pipe  93  connected to the guide tube  92 . The elevator wire  90  is in mechanical communication with the control system  14  so that manipulations at the control system  14  result in movement of the elevator wire  90  relative to the endoscope.  FIG. 3  depicts (in phantom) movement of the elevator  43  when the elevator wire  90  is actuated at the control system  14 , moving the position of the elevator  43  about the elevator turning support  68  as the elevator wire  90  is retracted or pulled.  
         [0034]      FIG. 5  illustrates an outer catheter  112  in accordance with one embodiment of the present invention. As shown, the outer catheter  112  includes an outer surface  114  having axial notches or grooves  120  formed thereon. In this embodiment, each of the grooves  120  is formed about a portion of the outer surface  114  of the outer catheter  112 . The formation of the grooves  120  allows the outer catheter  112  to be held or maintained within the grasping slot of the elevator, thereby allowing other components of the delivery apparatus to be moved relative thereto. For example, as shown, the wire guide  56  may be longitudinally moved to allow deployment of a stent  123  at the target location in the patient anatomy. Other uses may include holding the catheter within the grasping slot of the elevator such that an inner catheter may be advanced therethrough.  
         [0035]     In this embodiment, the elevator  43  is moved about the elevator turning support  68  by manipulating or actuating the control system  14  to pull or retract the elevator wire  90 . As the grooves  120  engage and cooperate with the elevator, the outer catheter  112  moves in the direction of the arrow P and pushes the elevator  43  against the cuff  60  (see  FIG. 4 ). Because the outer catheter  112  is relatively axially stiff, it tends to remain straight when pushed against the cuff  60 , creating a reactive force in the direction of the arrow Fr in  FIG. 4 . By means of this reactive force, the catheter  112  is pressed against the slot  91 . Moreover, as the elevator  43  and the cuff  60  press against one another, the grooves  120  of the catheter  112  maintain the catheter engaged with the elevator.  
         [0036]      FIGS. 6 and 7  depict the outer catheter  112  in contact and received within the elevator  43  of the endoscope. As shown, the outer catheter  112  is received preferably by the the elevator  43  and is held therein such that movement of other components such as a wire guide is facilitated, thereby deploying a medical device such as the stent  123  to the target location in the patient anatomy  141  or  143 . The grooves  120  are formed along the radial axis of the catheter  112  to allow the clinician to longitudinally move a wire guide  56  (or inner catheter) as needed or desired within the patient anatomy. In use, the elevator  43  is preferably actuated to move the elevator  43  away from the distal tip of the endoscope, thereby moving the outer catheter  112 . The outer catheter  112  may then be held within the grasping slot as the wire guide  56  or an inner catheter is retracted therethrough to deploy the stent  123 . As a result, the grooves  120  allow the outer catheter  112  to be held within the grasping slot  91  to allow for more precise and accurate deployment of the medical device in the patient anatomy.  
         [0037]     The embodiments of the present invention discussed herein may be used with the embodiments discussed in the U.S. Non-Provisional Application filed on Mar. 5, 2007 entitled “ENDOSCOPIC ELEVATOR APPARATUS.” Such application claims the benefit of U.S. Provisional Application Ser. No. 60/779,182, filed on Mar. 3, 2006, entitled “ENDOSCOPIC ELEVATOR APPARATUS HAVING A POLYMERIC ELEVATOR WITH A GRASPING SLOT” and U.S. Provisional Application Ser. No. 60/779,181, filed on Mar. 3, 2006, entitled “ENDOSCOPE HAVING AN ELEVATOR WITH A GRASPING COVER,” the entire contents of each are incorporated herein by reference.  
         [0038]     While the present invention has been described in terms of preferred embodiments, it will be understood, of course, that the invention is not limited thereto since modifications may be made to those skilled in the art, particularly in light of the foregoing teachings.