Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This 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,” the entire contents of which are incorporated herein by reference.  
         [0002]     This application also claims the benefit of 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 which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0003]     The present invention relates to medical devices, and more particularly, to endoscopic apparatus having a medical instrument elevator.  
       BACKGROUND OF THE INVENTION  
       [0004]     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.  
         [0005]     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.  
         [0006]     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.  
         [0007]     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.  
         [0008]     Many current endoscopic systems include endoscopes having an elevator used to orient and/or to lock the distal end of the catheter or wire guide. In many of such endoscopes, the elevator includes a v-shaped groove. The v-shaped groove is typically used to guide the catheter or 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 catheter or guide wire.  
         [0009]     Endoscopes using a rigid elevator lock and/or a v-shaped groove arrangement, however, may be improved. For example, in many situations, the elevator may tear, scrape, or otherwise affect wire guides or other instruments used therewith. This is particularly a problem with soft, Teflon™-coated wire guides. When such wire guides are positioned within the v-shaped groove of the elevator, even slight axial movement of the wire guide may result in a torn, scraped, or stripped wire guide. Such damage to a wire guide may undesirably require replacing the wire guide during the procedure. This, in turn, undesirably lengthens the overall procedure time and may increase the cost thereof.  
         [0010]     Many other endoscopes are provided with rigid, flat-edged elevators. One challenge is that wire guide orientation is difficult to control with flat-edged elevators. Specifically, the wire guide tends to move from side to side relative to the elevator, thereby challenging the physician to insert the wire guide into a target anatomy. Moreover, when flat-edged elevators are used to lock the distal end of an instrument, tearing, scraping, stripping or other undesirable effects on the instrument can also result.  
         [0011]     Another issue is that during use the elevator may compress elongate devices such as catheters, thereby preventing the passage of fluids therethrough or impeding the operation of the catheter device.  
         [0012]     Thus, there is a need for an elevator design that relatively firmly grasps a elongate medical device and reduces the risk of tearing, scraping, or stripping of devices (e.g., wire guides or catheter) during deployment in a body vessel and allows flow of fluid therethrough during use.  
       BRIEF SUMMARY OF THE INVENTION  
       [0013]     The embodiments of the present invention provide an endoscopic elevator system and an endoscopic assembly having enhanced features for grasping of a medical device, e.g., a catheter or wire guide. The present invention solves some of the current challenges in the endoscope industry. That is, embodiments of the present invention provide a way, during an endoscopic procedure, to maintain a relatively firm grasp of the medical device while reducing the risk of scraping, tearing, or stripping the medical device.  
         [0014]     In one embodiment, the present invention provides an endoscopic elevator apparatus cooperable with an insertion tube extending to a distal tip and having enhanced grasping and reduced scraping of an elongate medical device. The apparatus comprises an elevator movably attached to the distal tip. The elevator has an inner side formed thereon defining a grasping slot for engagement with the endoscope. The elevator has a surface projection disposed thereon for inhibiting damage to the elongate medical device.  
         [0015]     In another embodiment, the apparatus includes a grasping cover disposed over the elevator. The grasping cover includes a body having an open lip, defining an opening through which the elevator is received. The grasping cover has the surface projection disposed thereon.  
         [0016]     The yet another embodiment, the present invention comprises an endoscopic system for reduced scraping of an elongate medical device. The system comprises an insertion tube extending to a distal tip including an elevator movably attached to the distal tip. The elevator has an inner side formed therethrough, defining a grasping slot for engagement with the endoscope. The elevator has a surface projection disposed thereon for inhibiting damage to the elongate medical device.  
         [0017]     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  
       [0018]      FIG. 1   a  is a perspective view of an endoscopic system comprising an endoscope in accordance with one embodiment of the present invention;  
         [0019]      FIG. 1   b  is a perspective view of the endoscope depicted in  FIG. 1   b;    
         [0020]      FIG. 1   c  is an elevated view of a distal tip of the endoscope in accordance with one embodiment of the present invention;  
         [0021]      FIG. 2  is an enlarged view of the distal tip of the endoscope in accordance with one embodiment of the present invention;  
         [0022]      FIG. 3  is a cross-sectional view of the distal tip of the endoscope insertion portion of the endoscope taken along line  3 - 3 ;  
         [0023]      FIG. 4  is a side view of an elevator in accordance with one embodiment of the present invention;  
         [0024]      FIG. 5  is a cross-sectional view of the tip of the endoscope of  FIG. 1 , depicting a wire guide secured by an elevator;  
         [0025]      FIG. 6  is an elevated view of an elevator in accordance with one embodiment of the present invention;  
         [0026]      FIG. 7  is a cross-sectional view of the elevator in  FIG. 6  taken along line  7 - 7  in accordance with one embodiment of the present invention;  
         [0027]      FIGS. 8   a - 8   c  are elevated views of elevators in accordance with other embodiments of the present invention;  
         [0028]      FIG. 9  is an elevated view of an elevator according to another embodiment of the present invention;  
         [0029]      FIG. 10  is a side view of the elevator in  FIG. 6  having engaging ribs according to one embodiment of the present invention; and  
         [0030]      FIGS. 11   a - 11   c  are enlarged side views of the elevator in circle  11  of  FIG. 10  in accordance with examples of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0031]     The present invention generally provides an endoscopic elevator and an endoscopic assembly having enhanced features of grasping and reduced scraping of a medical device. Embodiments of the present invention allow a practitioner to relatively firmly grasp the medical device within an endoscope, while reducing the risk of scraping, tearing, or stripping of the medical device (e.g., catheter, wire guide. In one embodiment, a polymeric endoscopic elevator generally comprises inner sides defining a slot within which a medical device (e.g., catheter, wire guide) is disposed. Each of the inner sides has a grasping ridge or rib formed thereon. In another embodiment, the elevator generally includes a polymeric grasping cover disposed over the elevator. The grasping cover includes a body having an open lip defining an opening through which the elevator is received. The grasping cover has the at least one surface projection disposed thereon for enhanced grasping and reduced scraping.  
         [0032]      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.  
         [0033]      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 a channel port through which endoscopic units may be disposed. In one embodiment, endoscopic units disposed in one of the ports may include one embodiment of an improved elevator having a distal tip.  
         [0034]     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  13  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. In one example, the distal end of the insertion tube  12  is inserted, rectally or orally, to a predetermined endoscopic location within a patient. Insertion of the insertion tube  12  may be rectally or orally depending on the endoscopic procedure. The endoscope, in combination with the elevator having the distal tip, reduces the risk of tearing or scraping of the wire guide.  
         [0035]     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 , irrigation bottle  37 , and other suitable apparatus that are installed on a rack  39  equipped with rollers  38 .  
         [0036]     As shown in  FIGS. 1   c  and  2 , a 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.  
         [0037]      FIGS. 1   c  and  2  further illustrate 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  92  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., catheter or wire guide) and grasping the device during operation of the endoscope.  
         [0038]     As depicted in  FIG. 2 , tip  30  further includes a guide catheter  52  and a wire guide  56  disposed through the guide catheter  52 . The tip  30  further includes an elevator  43  configured to receive the guide catheter and/or wire guide for elevating the guide catheter  52  or wire guide  56 . As will be described in greater detail below, the elevator  43  is comprised of polymeric material and has a grasping slot formed therethrough for enhanced grasping and reduced scraping purposes.  
         [0039]     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  FIG. 3 , 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.  
         [0040]      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., high density polyethylene or polypropylene. 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 .  
         [0041]      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.  
         [0042]     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 shown in  FIG. 5 , the result moves the wire guide  56  in the direction of the arrow P and pushes the elevator  43  against the cuff  60 . Because the wire guide  56  is formed from a relatively axially stiff material, it tends to remain straight when pushed against the cuff  60 , creating a reactive force in the direction of the arrow Fr in  FIG. 5 . By means of this reactive force, the wire guide  56  is pressed against the slot  91 . Moreover, as the elevator  43  and the cuff  60  press against one another, the wire guide is secured.  
         [0043]     In another embodiment,  FIGS. 4 and 5  illustrate the elevator  43  having a transverse passageways  102  and  103  formed therethrough, each having optional metal sleeves  104  and  105 , respectively, disposed thereon. The metal sleeves are configured to provide transverse rigidity to the elevator. The proximal end of the elevator  43  is attached so as to pivot around the elevator turning support  68  provided to the cuff  60 .  
         [0044]     The elevator  43  is preferably comprised of polymeric material. The polymeric material may include polytetrafluoroethylene (PTFE), polyethylene, polypropylene, perfluoroelastomer, fluoroelastomer, nitrile, neoprene, polyurethane, silicone, styrene-butadiene, rubber, or polyisobutylene, or a mixture thereof. The polymeric material aids the elevator in relatively firmly grasping the medical device while reducing the risk of tearing, scraping, or striping of the medical device.  
         [0045]      FIG. 6  illustrates the elevator  43  comprising a grasping slot  130  in accordance with one embodiment of the present invention. The grasping slot may take on any suitable shaped or form for grasping of a medical device. In this embodiment, the grasping slot  130  is narrowly formed by inner sides  132  that define the grasping slot  130  through the elevator  43 . Preferably, the grasping slot  130  is centrally formed through the elevator  43  for receiving a medical device (e.g., catheter or wire guide) and grasping the device during operation of the endoscope.  
         [0046]      FIGS. 6 and 7  illustrate the elevator having inner sides  132  in accordance with one embodiment of the present invention. As shown, inner sides  132  include side surface projections  134  formed thereon. In this embodiment, side surface projections  134  are ridges or ribs that are oppositely formed laterally across each of the inner sides. Of course, the side surface projections may be formed on either or both of the inner sides, in any suitable shape, and in staggered configuration. For example, the inner surface projections may be formed longitudinally or in various patterns without falling beyond the scope or spirit of the present invention.  
         [0047]     In use, the control system of the endoscope may be manipulated to actuate the elevator, moving the elevator to engage the medical device, e.g., catheter or wire guide. By force, the medical device is worked through the grasping slot  130  of the elevator  43 , thereby engaging the medical device with the inner sides  132  of the elevator  43 . The side surface projections  134  engage the device and, due to the polymeric material of the elevator  43 , partially deform and absorb the device to reduce the risk of scraping thereof. In use, the side surface projections  134  receive the medical device when disposed within the slot for enhanced grasping and reduced risk of scraping of the medical device.  
         [0048]     In addition to reducing the risk of tearing and scraping, the formation of the slot allows a physician to more firmly grasp and secure the distal end of an instrument or wire guide relative to other endoscopes. To avoid further stripping or otherwise damaging an instrument or wire guide, cuff  60  can be provided with an elastomeric outer surface  66  (see  FIG. 3 ).  
         [0049]      FIGS. 8   a - 8   c  further illustrate various configurations of grasping slots  140 ,  150 ,  160  formed through the elevator. As mentioned above, the grasping slots may take on any desirable or suitable shape for grasping of a medical device of an endoscope. For example, as shown in  FIG. 8a , the grasping slot  140  of elevator  141  may have a cross-sectional shape that is semi-circular or arcuate. In this embodiment, the grasping slot  140  has an arcuate side  142  that defines the grasping slot  140 . As shown, the arcuate side  142  includes surface projections  144  formed thereon for grasping the medical device.  
         [0050]      FIG. 8   b  illustrates grasping slot  150  of elevator  151  in accordance with another embodiment of the present invention. As shown, the grasping slot  150  has inner and arcuate sides  152  that define the slot  150 . In this embodiment, the sides  152  include surface projection  154  formed thereon for grasping the medical device. In this embodiment, the grasping slot  150  takes on a keyhole shape, having relatively narrow planar sides  151  and widening to an arcuate side  153 . In use, the medical instrument, e.g., a catheter or a wire guide, may be worked between the planar sides  151  and received by the arcuate side  153 . As shown, the surface projections  154  disposed immediately proximate the arcuate side  153  on the planar sides serve to hold or biased the medical instrument within the grasping slot  150  against the arcuate side  153 . This provides enhanced grasping of the medical instrument within the apparatus.  
         [0051]      FIG. 8   c  illustrates grasping slot  160  of elevator  161  in accordance with yet another embodiment of the present invention. As shown, the grasping slot  160  has tapered and arcuate sides  162  that define the slot  160 . In this embodiment, the sides  162  include surface projections  164  formed thereon for grasping the medical device. In this embodiment, the grasping slot  160  once again takes on a keyhole shape, but having planar sides  161  that flare outwardly to receive a medical instrument such as a catheter or a wire guide. As shown, the planar sides  161  then extend to an arcuate side  163 . In use, the medical instrument may be worked between the planar sides  161  and received by the arcuate side  163 . As shown, the surface projections  164  that are disposed immediately proximate the arcuate side  163  on the planar sides serve to hold or biased the medical instrument within the grasping slot  160  against the arcuate side  163 . This provides enhanced grasping of the medical instrument within the apparatus.  
         [0052]      FIG. 9  illustrates the elevator  43  comprising a grasping cover or tip  212  disposed on the elevator  43  in accordance with another embodiment of the present invention. In this embodiment, the tip  212  is disposed over the elevator  43  and adhered thereon by any suitable means, e.g., sonic bonding, thermal bonding, or adhesive bonding. As shown, the tip  212  comprises a body  213  having a plurality of lateral ridges or ribs  214  formed thereon. The body  213  has an open lip  215  defining an opening  216  through which the elevator  43  is received. The body  213  is disposed on the elevator  43  with at least one and preferably a plurality of surface projections or ridges  214  positioned thereacross to receive and contact the device. The surface projections  214  may be formed across the body  213  in any suitable manner, e.g., laterally or longitudinally thereacross.  
         [0053]     The grasping cover or tip  212  may be made of any suitable material that will cooperate with the device to absorb and deform when in contact therewith, thereby reducing the risk of tearing or scraping of the wire guide. Preferably, the grasping cover  212  is made of polymeric material. For example, the grasping cover  212  may be made of at least one of the following components: polytetrafluoroethylene, polyethylene, polypropylene, perfluoroelastomer, fluoroelastomer, nitrile, neoprene, polyurethane, silicone, polytetrafluroethylene, styrene-butadiene, rubber, and polyisobutylene.  
         [0054]     As shown in  FIGS. 9 and 10 , the lateral ridges  214  are configured to contact and engage the device, e.g., wire guide or catheter, within the endoscope during usage thereof. The lateral ridges  214  aid in retaining and guiding the wire guide  56 , while also reducing the risk of tearing or scraping the wire guide. This is accomplished due to the lateral structure of the ridges  213  and the composition thereof. The ridges  214  may take on any desirable or suitable formation to contact the device (e.g. wire guide).  
         [0055]     In addition to reducing the risk of tearing and scraping, the tip  212  allows a physician to more firmly grasp and secure the distal end of an instrument or wire guide relative to the endoscope as compared to endoscopes having bare, rigid elevators. To avoid further stripping or otherwise damaging an instrument or wire guide, cuff  60  can be provided with an elastomeric outer surface  66  (see  FIG. 3 ).  
         [0056]      FIGS. 11   a - 11   c  further illustrate various configurations of ridges or ribs  214 ,  220 ,  224 , respectively, formed on the elevator. As mentioned above, the ridges  214  may take on any desirable or suitable shape for contact with the wire guide. As shown in  FIGS. 11   a - 11   c  for example, the ridges  214 ,  220 ,  224  may have a cross-sectional shape that is semi-circular or arcuate ( FIG. 11   a ), triangular ( FIG. 11   b ), or rectangular ( FIG. 11   c ).  
         [0057]     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.

Technology Category: 1