Patent Publication Number: US-2009221873-A1

Title: Adaptor for Endoscopic Orientation of an Elongate Medical Device

Description:
RELATED APPLICATIONS 
     This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Ser. No. 61/026,391, filed Feb. 5, 2008, which is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     This invention generally relates to an adaptor for elongate medical devices that are insertable into an endoscope, and in particular to an adaptor for orienting the medical device relative to the endoscope. 
     BACKGROUND 
     Endoscopic devices and procedures may be used to diagnose, monitor and treat various conditions by close examination of the internal organs. By way of background, a conventional endoscope generally is an instrument having a device for visualizing the interior of an internal region of a body and a lumen for inserting one or more treatment devices therethrough. A wide range of applications have been developed for the general field of endoscopes including by way of example the following: arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), laparoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and utererscope (individually and collectively, “endoscope”). 
     In some endoscopic devices, visualization of the internal regions may be obtained using a video camera. The video camera provides a viewing field to observe the surgical instrumentation or procedure within the viewing field. Medical ultrasound has also been used to monitor a surgical procedure within a viewing field. Endoscopic ultrasound (EUS) utilizes high frequency sound waves to create an image of living tissue or an echogenic surface. Ultrasound waves are emitted from transducers located at the distal end of an endoscope. Surgical instruments having an echogenic surface reflect the ultrasound waves and enable an endoscopist to monitor the location of the device within the patient. 
     In some procedures, medical devices are inserted through the endoscope to access the internal organs. For example, an elongate device, such as a needle, may be inserted through an accessory channel of the endoscope for removing tissue or cell samples, or injecting a medication or diagnostic fluid. Fine needle aspiration (FNA) has been a well accepted method for obtaining tissue samples for pathologic or histological analysis in diagnosing a lesion, tumor neoplasm or other abnormality in internal organs. EUS and EUS-guided fine needle aspiration (EUS-FNA) have become important tools in the evaluation of tissue and cell abnormalities. 
     Surgical techniques for obtaining tissue samples accessible through an endoscopic device such as an ultrasound-endoscope using a fine needle usually require repeated needle sampling at a tissue site to ensure an adequate sample for analysis. Typically in a biopsy procedure, a distal tip of the elongate medical device is extended distally from a port of the endoscope channel to reach the sample site. A sample is removed from the patient through the distal tip, the distal tip is retracted back through the channel and the sample is collected. The elongate medical device is reinserted into the channel of the endoscope and the distal tip of the device is subsequently re-extended distally through the endoscope to collect another sample. When an EUS system is used, it is important for the endoscopist to be able to re-extend the distal tip of the medical device at the correct angle so that the tip is visible in the EUS plane where the ultrasound waves are emitted. With the tip extended in the EUS plane, a subsequent sample may be obtained. 
     One problem with repeated sampling using an elongate device viewed with an EUS system, such as a needle, is that the distal tip of the device may curve or bend upon exiting a port of the endoscope. The deformation of the device may be such that the bend or curve formed during the previous extension remains in the distal tip when the distal tip is distally re-extended from the endoscope for the subsequent sampling procedure. The curved distal end of the sampling device will impair the endoscopist&#39;s ability to view the distal tip if the bend causes the tip of the device to project at an angle that is out of the EUS viewing plane. Simply reinserting the elongate device through the accessory channel and distally extending the tip may not allow the endoscopist to view the re-extended tip in the EUS viewing plane once the bend or curve has been introduced into the distal tip of the medical device. Similarly, other devices having an orientatable distal end extending from an endoscope may need to be oriented upon reinsertion through a channel of the endoscope so that the distal end of the medical device extends in the desired viewing plane. Viewing devices such as an imaging camera may also have requirements for a medical device to be re-extended into the viewing plane. 
     For the foregoing reasons, it is desirable to have an adaptor for an endoscope, as taught herein, that orients the distal tip of an elongate medical device that extends distally from the endoscope relative to the endoscope. 
     SUMMARY OF THE INVENTION 
     Accordingly, it is an object of the present invention to provide an adaptor for an endoscope having features that resolve or improve on one or more of the above-described drawbacks. 
     The foregoing object is obtained in one aspect of the present invention by providing an adaptor to orient an elongate medical device in relation to an endoscope. The adaptor includes a first portion having a distal end connectable and rotationally securable to an endoscope and a proximal end. The first portion further includes a first lumen defined longitudinally therethrough and one of an orienting key or a keyway extending longitudinally at least partially along the first portion. The adaptor further includes a second portion connectable to the first portion and having a second lumen extending longitudinally through the second portion and operably connectable to the first lumen. The second portion has the other of the key or the keyway extending longitudinally at least partially along the second portion. The keyway is configured to releasably mate with the key to orient and rotationally secure the second portion relative to the first portion. The second portion is configured to receive an elongate medical device longitudinally movable in relation to the second portion and rotationally secured relative to the second portion, the elongate medical device adapted to extend distally through the endoscope and having a tip that is orientable in relation to a distal portion of the endoscope portion. The adaptor is configured to orient the tip portion relative to the endoscope. 
     In another aspect, an system is provided to orient an elongate medical device relative to an endoscope. The system includes an endoscope, an adaptor connected to the endoscope and an elongate medical device rotationally secured to a second portion of the adaptor. The adaptor includes a first portion and a second portion. The first portion includes a connecting portion to rotationally secure a distal end of the first portion to the endoscope, a first lumen extending longitudinally through the first portion and operably connectable to a working channel of the endoscope, and one of an orienting key or a keyway extending longitudinally at least partially along the first portion. The second portion is releasably connectable to the first portion and includes the other of the key or the keyway extending longitudinally along at least a portion of the second portion and a second lumen operably connectable to the first lumen and configured to receive an elongate medical device rotationally secured in relation to the second portion therethrough. The other of the key or the keyway is configured to engage the key or the keyway on the first portion to rotationally fix the second portion in relation to the first portion. 
     In another aspect, a method of orienting an elongate medical device extending through a working channel of an endoscope and having a distal tip portion extending distally through the endoscope. The method employs an adaptor including a first portion and a second portion, the second portion having an elongate medical device rotationally secured thereto. The method includes connecting a first portion of the adaptor to the endoscope so as to rotationally secure the first portion in relation to the endoscope and operably connect a first lumen of the first portion with the working channel of the endoscope. The method further includes extending a distal portion of an elongate medical device longitudinally through the first lumen and into the working channel of the endoscope and connecting the second portion to the first portion and rotationally securing the second portion to the first portion by engaging one of a key or a keyway on the second portion to the other of the key or the key way on the first portion. 
     Advantages of the present invention will become more apparent to those skilled in the art from the following description of the preferred embodiments of the invention which have been shown and described by way of illustration. As will be realized, the invention is capable of other and different embodiments, and its details are capable of modification in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side perspective view of an adaptor according to the present invention: 
         FIG. 2  is a side perspective view of the adaptor shown in  FIG. 1  with a first portion of the adaptor connected to an endoscope; 
         FIG. 3A  is a cross-sectional view of an alternative key/keyway configuration; 
         FIG. 3B  is a cross-sectional view of another alternative key/keyway configuration; 
         FIG. 3C  is a cross-sectional view of another alternative key/keyway configuration; 
         FIG. 3D  is a cross-sectional view of another alternative key/keyway configuration; 
         FIG. 3E  is a cross-sectional view of another alternative key/keyway configuration; 
         FIG. 4  is a side view of a portion of an elongate medical device including a sheath and a needle; 
         FIGS. 5A and 5   c  illustrate an exemplary handle of a needle device that may be oriented with the adaptor; 
         FIG. 5  B is a cross-sectional view through the second portion shown in  FIG. 5A ; 
         FIG. 6  side view of an exemplary endoscope having an accessory channel for attachment of the adaptor of shown in  FIG. 1 ; 
         FIG. 7A  is a partial view of an elongate medical device extending distally from an endoscope into a viewing field; 
         FIG. 7B  is a partial view of the elongate medical device shown in  FIG. 7A  re-extending distally from an endoscope and curving out of the viewing field; and 
         FIG. 7C  is a partial view of the elongate medical device shown in  FIG. 7A  re-extending distally from an endoscope into the viewing field using the adaptor shown in  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention are not limited to the embodiments illustrated in the drawings. It should be understood that the drawings are not to scale, and in certain instances details have been omitted which are not necessary for an understanding of the present invention, such as conventional fabrication and assembly. 
     As used in the specification, the terms proximal and distal should be understood as being in the terms of a physician operating an endoscope and an elongate medical device for insertion into a patient. Hence the term distal means the portion of the device that is farthest from the physician and the term proximal means the portion of the device that is nearest to the physician. 
       FIG. 1  illustrates an adaptor  10  in accordance with embodiments of the present invention. The adaptor  10  is configured for removable connection to an endoscope  20  (shown in  FIG. 6  and described in more detail below). The adaptor  10  includes a first portion  22  and a second portion  24 . The first portion  22  and the second portion  24  may be releasably connectable to each other wherein the first portion  22  includes one of a key or a keyway and the second portion  24  includes the other of the key or the keyway to rotationally secure the second portion  24  in relation to the first portion  22 .  FIG. 1  illustrates the adaptor  10  having one of the many combinations possible for the key and the keyway. 
     As shown in  FIG. 1 , the first portion  22  includes a distal end  26  that may be connected to a connector  28  on an accessory channel  30  of the endoscope  20 . The first portion  22  further includes a lumen  32  extending longitudinally therethrough. An orienting key  34  is shown in  FIG. 1  extending into the lumen  32  at a proximal end  36  of the first portion  22 . The key  34  extends longitudinally along at least a portion of the lumen  32  and is not required to extend all the way to the proximal end  36 . The first portion  22  may be connected to the connector  28  of the endoscope  20  using any connection known to one skilled in the art that will secure the rotational orientation of the first portion  22  once the first portion  22  is connected to the endoscope  20 . Non-limiting exemplary connections include threaded (as shown), snap-fit, and the like. The first portion  22  may be connected and secured to the endoscope  20  in any rotational orientation in relation to a longitudinal axis of the endoscope  20 . Once the first portion  22  is connected to the endoscope  20 , the first portion  22  remains secured in position on the endoscope throughout the procedure. The first portion  22  may be removed from the endoscope  20  once the procedure has been completed. 
     The second portion  24  of the adaptor  10  includes a lumen  38  extending longitudinally therethough. The second portion  24  is configured to be removably connected to the first portion  22 . When the first portion  22  is connected with the second portion  24 , the lumens  32  and  38  are operably connected. The second portion  24  further includes an exterior surface  42  having a keyway  44  for engaging the key  34  of the first portion  22 . As shown in  FIG. 1 , the second portion  24  is sized and shaped so that at least a distal end  50  of the second portion  24  is received into the lumen  32  at the proximal end  36  of the first portion  22 . The keyway  44  of the second portion  24  engages the key  34  of the first portion  22  so that the second portion  24  is rotationally secured in relation to the first portion  22  and also to the endoscope  20 . One skilled in the art will understand that the second portion  24  may be releasably connected to the first portion  22  by having the distal end  50  of the second portion  24  received over the proximal end  36  of the first portion  22 . In one alternative embodiment, the key or keyway may be on the exterior of the first portion  22  and the other of the key or keyway may extend into the lumen  38  of the second portion  24 . In other words, the second portion  24  may be configured to slide over the first portion  22 . 
     The key and keyway configuration described above for the adaptor  10  may have any size and shape known to one skilled in the art. By way of non-limiting example, the shape may be rectangular, circular, oval, triangular, and the like. Any releasably mating configuration may be used to rotationally secure the second portion with respect to the first portion of the adaptors described herein. Two or more key/keyway pairs may be used to orient the first and second portions and rotationally secure the second portion with respect to the first portion. Additional example of exemplary key and keyway configurations are shown in  FIGS. 3A and 3B . Key  34   a  and keyway  44   a  refer to alternative configurations from the key  34  and keyway  44  shown in  FIGS. 1 and 2  where key  34   a  is on the second portion  24  and keyway  44   a  is on the first portion  22 . The key and keyway may also be formed from the shape of the first portion and the second portion themselves.  FIGS. 3C-3E  illustrate a key/keyway configuration where the shape of the exterior of one portion forms the key  34   b  and the interior of the other portion forms the keyway  44   b . In each of the embodiments shown in  FIGS. 3C-3E , the key  34   b /keyway  44   b  orient and rotationally secure the second portion in relation to the first portion. The exterior of the adaptor may be cylindrical and include a lumen that extends therethrough as described above. 
     The connection between the first portion  22  and the second portion  24  may be friction fit so that the second portion  24  remains connected to the first portion  22  until the physician disengages the first portion  22  from the second portion  24 . The first portion  22  may also include a releasable locking mechanism, such as a thumb screw  51 , to hold the second portion  24  in a longitudinally secured position during a sampling procedure. The thumb screw  51  may also be used to limit or adjust the axial position of the second portion relative to the first portion. The connection between the first portion  22  and the second portion  24  is configured to be repeatedly removed and reconnected to reinsert the second portion  24  in an oriented direction in relation to the first portion  22  and the endoscope  20 . One skilled in the art will understand that other connections between the first portion  22  and the second portion  24  are possible. 
     The second portion  24  is configured to receive an elongate medical device therethrough as will be described in more detail below. The elongate medical device may be longitudinally movable within the second portion  24 , but not radially rotatable in relation to the second portion  24 . 
       FIG. 2  illustrates the first portion  22  of the adaptor  10  connected to the accessory channel  30  of the endoscope  20 . Once the first portion  22  is connected to the endoscope  20 , the key  34  remains secured in position relative to the endoscope  20  until the procedure is completed. The initial rotational position of the key  34  in relation to the endoscope does not matter as long as the key  34  remains in the same position in relation to the endoscope throughout a procedure where orientation of the medical device is important. The second portion  24  is shown being advanced toward the first portion  22  in  FIG. 2 . A portion of an elongate medical device  100  is shown extending from the second portion  24  and into the first portion  22  to enter the endoscope  20  through the accessory channel  30  to a channel of the endoscope (not shown). The keyway  44  of the second portion  24  may be aligned with the key  34  of the first portion  22  to rotationally secure the second portion  24  in relation to the first portion  22 . The second portion  24  and the medical device  100  may be repeatedly removed from and reinserted into the first portion  22 . 
     The second portion  24  may be connected to a handle  102  at a proximal end  104  of the medical device  100  as shown in  FIG. 2 . An exemplary distal end  106  of the medical device  100  is shown in  FIG. 4  where the distal end  106  includes a sampling end, such as needle  108  that extends from a sheath  110  of the medical device  100 . The needle may be made from any material known in the art, by way of non-limiting example, materials may include stainless steel or similar alloy, a memory-metal alloy, such as nickel titanium, a composite, a polymer, and/or a surgical stainless steel. The needle  100  may include an echogenic surface  112 . Examples of echogenic markers on medical devices may be found in U.S. Published Application 2006/0247530, the entire contents of which are hereby incorporated by reference. The needle  108  may be positioned within the sheath  110  as the sheath  110  of the medical device  100  is advanced through the channel  78  of the endoscope  20 . The needle  108  and the sheath  110  are provided in a fixed rotational orientation in relation to the second portion  24  and are longitudinally movable in relation to the second portion  24  using the handle  102 . The handle  102  may be used to releasably lock the needle  108  longitudinally in relation to the sheath  110 . Advancement of the needle  108  at the biopsy site will be described below. 
     The exemplary handle  102  of the medical device  100  is shown in  FIGS. 5A and 5C  illustrating possible longitudinal changes in the position of the medical device  100  in relation to the second portion  24 .  FIG. 5B  is a cross-sectional view of the second portion  24  taken across line  5 B- 5 B of  FIG. 5A . As shown in  FIG. 5A , the handle  102  may include a needle adjuster  114  to adjust the length of the extension of the needle  108  out of the sheath  110 . The needle adjuster may move along a shaft  118  of the handle  102  and include indicia  120  relating to the length that the needle  108  extends out of the sheath  110 . A locking mechanism  122  may be used to releasably lock the needle adjuster in position. For example, the needle adjuster  114  positioned at 0 indicates that the needle  108  is positioned within the sheath  110  for insertion through the endoscope  20 . A stylet  124  may extend longitudinally through the needle  108  to provide stiffness to the needle before sampling the tissue.  FIG. 5B  illustrates a cross sectional view of the second portion  24  having the keyway  44  and the sheath  110  and the needle  108  extending through the lumen  38  (stylet  124  not shown). 
       FIG. 5C  illustrates the second portion  24  connected to the first portion  22  and rotationally secured. The second portion  24  may be longitudinally adjusted in relation to the second portion  22 . Indicia  128  on the second portion  24  indicate the longitudinal position of the second portion  24  in relation to the first portion  22  and may be viewed through an opening  130  in the first portion  22 . The locking mechanism  51  may be used to releasably secure the second portion  24 . The needle adjuster  144  may be moved along the shaft  118  to extend the needle  108  out of the sheath  110  when the medical device has been fully inserted into the endoscope  20  and the distal end  76  of the endoscope  20  is in position within the patient for tissue sampling. 
     An exemplary endoscope is shown in  FIG. 6 . The endoscope  20  includes an operating control portion  162  in mechanical and fluid communication with an insertion tube  164 . The operating control portion  162  is configured to control the insertion tube  164  and endoscopic parts disposed therein. As shown, the control portion  162  includes first and second control knobs  166 ,  168 . The control knobs  166 ,  168  are configured to be in mechanical communication with the insertion tube  164 . The control knobs  166 ,  168  allow the endoscopist to control and guide, by known means, the insertion tube  64  through the vessels and cavities of the patient. The control portion  162  may further include a plurality of ports, such as a suction port  170  and an air/water port  172 . Each of the ports of the endoscope  20  is in communication to one of the working channels  173  of the insertion tube  164 . 
     The endoscope  20  also includes an accessory channel  30  having a lumen  178  extending from the connector  28  to the distal end  176  of the endoscope  20 . The accessory channel  30  is configured to receive medical devices, such as the medical device  100 , therethrough for performing procedures through the distal end  176  of the endoscope  20  as is known in the art. The adaptor  10  described above is configured to removably connect to the connector  28  to orient the medical device  100  in relation to the endoscope  20 . 
     As shown in  FIG. 6 , the exemplary endoscope  20  may further include an ultrasonic array of transducers  174  at the distal end  176  of the insertion tube  164 . The transducers  174  may be connected to an imaging system (not shown) for viewing the image created by the ultrasonic transducers  174  and a medical device with an echogenic surface. The transducers  174  generate an ultrasonic scanning plane  180  to permit real-time monitoring of the medical device location and orientation within the scanning plane  180 . Medical devices such as needles, including those for fine needle aspiration, wire guides, biopsy forceps and the like may include an echogenic surface and may be extended out of a port  182  in the distal end  176  of the endoscope  20  and viewed in the scanning plane  180 . 
       FIGS. 7A-7C  illustrate the orientation of the exemplary medical device  100  using the adaptor  10  described above. By way of non-limiting example, the medical device  100  may be a needle, such as an EUS-FNA biopsy needle that may be used to sample lymph nodes, as well as masses arising in the lungs, pancreas, liver, adrenal gland and bile duct. In operation, the first portion  22  may be secured to the connector  28  of the endoscope  20  as shown in  FIG. 2  to rotationally secure the first portion  22  in relation to the endoscope  20 . A distal tip  111  if the sheath  110  of the medical device  100  (see  FIG. 4 ) may be inserted into the lumen  32  of the first portion  22  and into the lumen  178  of the endoscope  20 . The second portion  24  of the adaptor  10  is oriented so that the key  34  of the first portion and the keyway  44  of the second portion align, engage and are releasably connected. With the key  34  and the keyway  44  engaged, the second portion  24  is rotationally secured in relation to the first portion  22 . The second portion  24  may be longitudinally moved in relation to the first portion  22  or the second portion  24  may also be secured longitudinally using for example, the thumb screw  51 . The handle portion  102  may be longitudinally moved as describe above in relation to the second portion  24  and the endoscope  20  to extend the needle  108  and the sheath  110  of the medical device  100  out of the distal end portion of the endoscope  20 . 
       FIG. 7A  illustrates the distal end  176  of the insertion tube  164  of the endoscope  20  that has been advanced down through a bodily lumen  190  to a tissue mass  192  at a sampling site. The distal end  176  of the endoscope  20  is maneuvered as close as possible to the tissue mass  192 . The sheath  110  is loaded into a proximal end  77  of the endoscope  20  through the accessory channel  30 . In order to load and orient the needle  108 , the adaptor  10  is used. As described above, the first portion  22  of the adaptor  10  is connected to the accessory channel  28  of the endoscope  20 . The second portion  24  of the adaptor  10  is engaged and rotationally secured to the first portion  22 . The second portion  24  is connected to the first portion  22  so that the key  34  receives the keyway  44  to rotationally secure the second portion  24  in relation to the second portion  22  of the adaptor  10 . The needle  108  within the sheath  110  of the medical device  100  is longitudinally extended through the endoscope  20  and emerge from the port  182  at the distal end  176  of the endoscope  20 . 
     The length of the adaptor  10  may be configured to be sufficient to allow the initial engagement, orientation and rotational securing of the second portion  24  in relation to the first portion  22  before the medical device  100  extends out of the distal end  176  of the endoscope  20 . Orienting and rotationally securing the second portion  24  in relation to the first portion  22  using the key  34 /keyway  44  before the medical device  100  extends out of the distal end  176  of the endoscope  20  allows the medical device  100  to be oriented before the medical device  100  passes through the portion of the endoscope  20  that induces bending into the medical device  100  as described above. The bend-inducing portion of the endoscope may be at the port  182  of the distal end  176 , by way of non-limiting example. However, one skilled in the art will understand that the bend-inducing portion may also be at other positions along the working channel  173  of the endoscope  20 . 
     The relationship between the length of the engagement region where the key  34  and the keyway  44  of the adaptor  10  initially connect and the distal extension of the medical device  100  is illustrated in the following example. If the length of the elongate medical device  100  that extends beyond the bend-inducing portion of the endoscope  20  is about 10 cm, then the length of the engagement region between the key  34  and the keyway  44  is at least about 10 cm so that the orientation of the medical device  100  relative to the endoscope  20  begins with the engagement of the key  34  and the keyway  44  and before the medical device  100  extends through the bend inducing portion. 
       FIG. 7A  illustrates the needle  108  in the first position  108   a  for the first extension of the needle  108  into the scanning plane  180  generated by the ultrasonic transducers  174 . In the first position  108   a , reflections off an echogenic surface  112  on the needle  108  allow visualization of the path of the needle  108  relative to the mass  192  to be monitored. After the needle  108  has been guided to the tissue mass  192 , the endoscopist may puncture the mass with swift back and forth movements of the needle  108 . Upon successful sampling of the tissue mass  192 , the needle  108  may be longitudinally retracted out of the scanning plane  180  and the second portion  24  of the adaptor  10  disconnected from the first portion  22  and the medical device  100  removed from the endoscope. Aspiration of the contents from the tissue mass  192  includes may include application of negative pressure with a syringe (not shown) over the sheath  110 . As the needle  108  is retracted longitudinally through the port  182  to and out of the accessory channel, the needle may become bent or curved. 
     One or more additional samplings may be completed while the distal end  176  of the endoscope  20  remains optimally positioned near the tissue mass  192 . The second portion  24  of the adaptor  10  may be reconnected to the first portion  22  in the same rotational orientation as the original connection using the key/keyway  34 ,  44  orientation to ensure that the needle  108  will extend in substantially the same position  108   a  as in the first sampling procedure shown in  FIG. 7A . The rotational orientation of the needle  108  using the adaptor  10  is shown for the first extension in  FIG. 7A  and subsequent extensions in  FIG. 7C . If the adaptor  10  is not used to rotationally orient the sheath  110  and needle  108 , the needle  108  may extend from the port  182  of the distal end  176  of the endoscope  20  in an angle outside of the scanning plane  180  as shown in  FIG. 7B .  FIG. 7B  illustrates a curved needle position  108   b  that extends out of the scanning plane  180  so that the needle  108  cannot be visualized and a tissue sample cannot be take at the tissue mass  192 . 
     In an alternative operation, the second portion  24  may be connected to the first portion  22  by orienting and engaging the key  34  and the keyway  44  and rotationally securing the second portion  24  in relation to the first portion  22  before connecting the first portion  22  to the endoscope  20 . The first portion  22  may then be connected to the connector  28  on the accessory channel  30  of the endoscope  20  having the elongate medical device  100  inserted into the endoscope  20  before completing the connection of the first portion  22  to the connector  28 . Once the first portion  22  is connected to the connector  28 , the first portion  22  remains connected and rotationally secured in relation to the endoscope  20  through out the procedure. A sample may be taken and the second portion  24  may be released from the first portion  22  to remove the medical device  100  from the endoscope  20 . The medical device  100  may be reinserted into the endoscope  20  as described above and the second portion  24  reconnected to the first portion  22  so that the medical device  100  is oriented with respect to the endoscope  20  in the same rotational relationship as the first sampling relationship and the needle  108  extends into the viewing plane  180  as described above. 
     As will be understood by a skilled artisan, the orienting adaptor may also be used with a conventional image system also having a viewing plane where a curved medical device may be re-extended from the distal tip of the endoscope outside of the viewing plane. In addition, many types of elongate medical devices, used for multiple extensions through the endoscope distal end and having an operational direction for the patient procedure may be used with the adaptor of the present invention. 
     The above Figures and disclosure are intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such variations and alternatives are intended to be encompassed within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the attached claims. For example, the invention has been described using an EUS needle for illustrative purposes only. Application of the principles of the invention to any other elongate medical device are within the ordinary skill in the art and are intended to be encompassed within the scope of the attached claims.