Abstract:
A medical tool includes a flexible sleeve placed over a flexible endoscope tube of an endoscope, with the flexible sleeve having one or more channels for providing additional access to the interior of a patient&#39;s body. Various tools may be inserted into the channels in order to perform surgical techniques within the body, such as within the gastrointestinal (GI) tract of the patient. Such insertable tools may include scalpels, scissors, or gripping tools. The tools may be flexible tools, and may include electrically-powered tools or non-electrically-powered tools.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/819,266 filed Jul. 7, 2006, which is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention is in the general field of medical tools, and more specifically relates to tools and methods involving endoscopes. 
         [0004]    2. Description of the Related Art 
         [0005]    An endoscope is a tubular medical tool used for imaging and/or performing actions inside the body of a patient, such as taking biopsies and retrieving foreign objects. Some endoscopes provide an additional channel to allow entry of medical instruments or manipulators into the body of the patient. Modern endoscopes may be rigid or be generally flexible, and may be utilized for diagnostic and/or treatment purposes in many parts of the body, such as in the gastrointestinal (GI) tract. For example, gastroscopy involves using an endoscope to examine and/or perform actions along the lining of the esophagus, stomach, or the duodenum. Gastroscopy is often used to diagnose and/or treat ulcers and other sources of bleeding, or to guide biopsy of suspected gastrointestinal cancers. Another type of endoscopy is colonoscopy, which is the examination of the inside of the colon and large intestine, such as for diagnostic purposes. 
         [0006]    Many endoscopic procedures are minimally invasive and cause only mild discomfort or pain, wherein only a topical anaesthesia is necessary. For these reasons, some patients prefer to undergo endoscopic surgery rather than other more invasive surgical procedures in order to reduce pain and time for recovery. Accordingly, the number of endoscopic surgeries is increasing, and doctors are attempting to perform increasingly complex procedures through the use of endoscopes. The result of complex endoscopic surgeries is that doctors must use a myriad of medical instruments wherein each instrument must be inserted into and removed from the additional channel of the endoscope. 
         [0007]    This process of repeatedly inserting and removing the instruments is not only more time consuming for the physician, but also more risky for the patient. Further, endoscopic instruments are costly to replace, and thus some doctors prefer to maintain their existing endoscopic instruments, thereby allowing them to monetize their existing equipment and also saving them the time and energy necessary to learn the operations of a new endoscope. 
       SUMMARY OF THE INVENTION 
       [0008]    Embodiments of the present invention relate to endoscopic instruments or similar tools used for imaging and/or performing actions inside the body of a patient, such as, for example, taking biopsies, cutting and/or suturing tissue, cauterizing, and retrieving objects. Various embodiments of the present invention can address some or all of the noted shortcomings associated with existing endoscopes. For example, and in accordance with one aspect of the present invention, a flexible channeled sleeve is provided to substantially surround or encapsulate at least a portion of an endoscope. The sleeve is preferably adapted to extend at least as long as the working length of the endoscope. Further, the sleeve is preferably configured to be attached to and work along side existing endoscopes. 
         [0009]    The sleeve attaches to the endoscope, preferably in a releasable manner, such that the sleeve does not slip up or down the endoscope to any substantial extent once the sleeve has been secured to the endoscope. The sleeve also comprises at least one outer member that defines a channel along the endoscope to allow a medical instrument to be passed through the channel to the surgical site. Preferred embodiments of the channeled sleeve are single-use, disposable, convenient to use, and significantly improve the efficacy and safety of a wide variety of endoscopic procedures. 
         [0010]    In accordance with another aspect of the present invention, a single-use, disposable sleeve is provided for use with an endoscope, which includes an elongated body having a working length that terminates at a distal end. The sleeve comprises a flexible elongated generally cylindrical hollow member having an inner size and a cross-section shape that generally matches the cross-section shape and size of the endoscope elongated body, at least along the working length, such that the endoscope fits within the hollow member. The hollow member has a wall thickness that is at least an order of magnitude smaller than the inner size of the hollow member and comprises a distal portion. The distal portion is configured for attachment to a distal portion of the endoscope to substantially secure the hollow member to the endoscope. At least one flexible elongated outer member is attached to the hollow member to define at least one elongated channel. The channel has a length that is at least substantially equal to the working length of the endoscope&#39;s elongated body, and has a sealed proximal end. The channel is sealed along it length and is sufficiently sized to receive a medical instrument. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The foregoing and other features, aspects and advantages of the present invention are described in detail below with reference to the drawings of preferred embodiments, which are intended to illustrate and not to limit the invention. The drawings comprise seventeen figures in which: 
           [0012]      FIG. 1  is a top plan view of an endoscope device, which represents an exemplary medical device with which the present channeled sleeve can be used; 
           [0013]      FIG. 2  is top plan view of the channeled sleeve device, which is configured in accordance with a preferred embodiment of the invention, as disposed on the endoscope of  FIG. 1 ; 
           [0014]      FIG. 3  is a top plan view of the channeled sleeve of  FIG. 2 ; 
           [0015]      FIG. 4A  is a cross-sectional view of the endoscope/sleeve assembly taken along line  4 - 4  of  FIG. 2 , with an outer member of the channeled sleeve generally in pre-expanded state; 
           [0016]      FIG. 4B  is an enlarged cross-sectional view of the endoscope/sleeve assembly of  FIG. 4A ; 
           [0017]      FIG. 5  is a cross-sectional view of the endoscope/sleeve assembly, similar to  FIG. 4A , with the outer member in an expanded or state; 
           [0018]      FIG. 6A  is an enlarged view illustrating the hollow member of the channeled sleeve device of  FIG. 2 , with a releasable band strip surrounding the endoscope and the hollow member with open distal ends of the channels; 
           [0019]      FIG. 6B  is an enlarged view illustrating another embodiment of the channeled sleeve device having channels with initially closed distal ends; 
           [0020]      FIG. 7A  is an enlarged cross-sectional view of a split clip of the channeled sleeve device of  FIG. 2 ; 
           [0021]      FIG. 7B  is a side elevational view of a split clip that is configured in accordance with another embodiment of the present invention; 
           [0022]      FIG. 8  is a cross-sectional view of an embodiment of the channeled sleeve device with an inner hollow member and a fused outer member; 
           [0023]      FIG. 9  is a cross-sectional view of another embodiment of the channeled sleeve device with multiple outer members fused to the inner hollow member; 
           [0024]      FIG. 10  is a schematic illustration of a medical instrument being inserted into the channeled sleeve device of  FIG. 2 ; 
           [0025]      FIG. 11  is a schematic illustration of a medical instrument being inserted into the channeled sleeve device having a proximal port configured in accordance with another preferred embodiment of the invention; 
           [0026]      FIG. 12  is an enlarged perspective view of a proximal port of the channeled sleeve device shown in  FIG. 11 , which is configured in accordance with a preferred embodiment of the present invention, for inserting medical instruments into the outer member of the channeled sleeve; 
           [0027]      FIG. 13  is a cross-sectional view of an endoscope/sleeve assembly where the channeled sleeve is configured in accordance with another preferred embodiment of the invention and where an outer member thereof is an expanded state; 
           [0028]      FIG. 14  is a top plan view of a channeled sleeve device configured in accordance with an additional preferred embodiment to have a tapered distal end; 
           [0029]      FIG. 15  is a top plan view of the channeled sleeve member having a tapered distal end configured in accordance with a further embodiment of the present invention; and 
           [0030]      FIG. 16  is a schematic illustration of the channeled sleeve device having perforations for adjusting the length of the sleeve, and being dispensable from a roll of like sleeves. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0031]    Embodiments of the present invention provide a channeled sleeve configured for attachment to an endoscope, which improves a clinician&#39;s ability to utilize multiple medical instruments during an endoscopic surgical procedure in a safe and efficient manner. In more preferred embodiments, the sleeve is a single-use, disposable device. However, it will be appreciated that embodiments of the described channeled sleeve and/or features thereof may be used in a wide variety of applications (including multi-use applications). 
         [0032]    The term “endoscope” includes but is not limited to elongated instruments used for imaging, diagnosing, and/or performing actions or treatments inside the body of a patient, such as taking biopsies and retrieval of foreign objects. In one preferred embodiment, the channeled sleeve is configured to be used with an endoscope and other medical instruments to perform a Natural Orifice Surgery (NOS), or more specifically a Natural Orifice Transluminal Endoscopic Surgery (NOTES). In either of the foregoing surgical procedures, the channeled sleeve is positioned on the endoscope, wherein the endoscope is positioned at the surgical site by passing through a natural orifice, for example, anus, ear, mouth, nose, urethra, vagina, or the like, and then through an internal incision in an area (for example, bladder, colon, ear canal, nostril, stomach, vagina, or the like) near the surgical site. However, many of the principles of the channeled sleeve described herein can also be used with other types of endoscopes or other surgical access/treatment devices, as well as with a wide variety of medical articles and/or instruments. For example, but without limitation, the channeled sleeve can be used with catheters, obturators, fluoroscopes, etc. 
         [0033]    In many embodiments, the channeled sleeve can be a single-use, disposable item having a working length that is attached to an endoscope (or other elongated medical article) to provide at least one outer channel configured to allow an additional medical instrument access to the surgical site simultaneously with an instrument passing through the endoscope. In some embodiments, the channeled sleeve is integrally formed onto such devices, and in other embodiments, the channeled sleeve is attached, retro-fitted, or secured to such devices. 
         [0034]    Thus, with reference to  FIG. 1 , there is illustrated an endoscope  100  with which the channeled sleeve can be used. As shown, the endoscope  100  comprises a distal portion  103 , which is intended for insertion into the patient&#39;s body, and a handle or hand piece  105 , which remains outside the patient&#39;s body. The hand piece  105  includes a distal end  108  from which an elongated body of the endoscope  100  extends. The endoscope  100  typically comprises an internal channel  107  for inserting medical instruments, and markers  106  that indicate the positioning of the endoscope  100  within the patient&#39;s body (i.e., the inserted length). 
         [0035]      FIG. 2  illustrates a preferred embodiment of the channeled sleeve  200  as positioned on the endoscope  100 . The sleeve  200  includes a distal end  203  and a proximal end  205 . In use, the distal end of the endoscope is slid into the sleeve&#39;s proximal end  205  and is advanced through the sleeve until it emerges from the sleeve&#39;s distal end  203 . 
         [0036]    The channel sleeve  200  includes an inner hollow member  201  that defines a channel, lumen, guide, or the like therein. In the illustrated embodiment, the hollow member  201  has a lumen with an inner size (e.g., a diameter) that substantially matches the outer size (e.g., an outer diameter) of the endoscope  100 . In some applications, however, the inner size can be slightly larger or smaller than the elongated body onto which the sleeve is disposed. The lumen of the hollow member  201  also has a cross-section shape that at least generally matches the cross-section shape of the endoscope  100 . 
         [0037]    The hollow member  201  has a length that is at least as long as the working length of the endoscope  200 , i.e., the length of the endoscope inserted into the patient in a given procedure. In some embodiments, as described below, the length of the sleeve  200  can be adjusted to suit a particular application. For example, where less of the instrument is inserted into the patient&#39;s body, due to the size of the patient, the working length of the endoscope will be shorter. In such applications, though, the hollow member  201  should have a length at least as long as the inserted portion of the instrument. 
         [0038]    The hollow member  201  comprises an interior surface  204  (shown in  FIG. 3 ) on which a lubricant, a coating, or the like, preferably is applied to or is integral with the surface  204  to facilitate the axial movement of the endoscope  100  through the hollow member  201 . In some preferred embodiments, the lubricant is silicon, mineral oils, KY jelly products, or the like. In some preferred embodiments, the coating is Teflon® or other coating that provides an impermeable low friction surface. In other embodiments, the endoscope is treated with a lubricant prior to inserting into the channel sleeve  200 . In such embodiments, the sleeve  200  can include a lubricated inner surface as well. 
         [0039]    At least the distal end of the channel sleeve  200  is attached to the endoscope  100  at a point near the distal end  103  of the endoscope  100 . Preferably, a seal is also formed between the channel sleeve  200  and the endoscope  100  to inhibit fluids, gases and other materials from escaping the surgical field through the space between the endoscope  100  and the hollow member  201 . In the illustrated embodiment, the distal portion  203  of the hollow member  201  comprises at least one band strip  207  for both of these purposes. The band strip  207  is preferably releasable, but need not be so. Also, while it is preferred that one mechanism be used to attach the sleeve  200  to the endoscope  100  and to form the seal, separate mechanisms can be used in other embodiments to perform each of these functions. 
         [0040]    As seen in  FIG. 3 , the band strip  207  has a base portion  208  that is attached to the distal portion  203  of the hollow member  201 . In this preferred embodiment, the band strip  207  is integrally formed with the hollow member  201 , although in other embodiments it can be fastened to the hollow member (e.g., adhered by a biocompatible adhesive). The band strip  207  extends away from the longitudinal axis of the hollow member, preferably at about 90°, although it can extend at other angles relative to the longitudinal axis. The band strip  207  terminates at an outer end portion  210 . 
         [0041]    The outer end portion  210  includes a fastener  212  to couple the outer end  210  to at least one of: (1) a portion of the band strip  207 ; (2) a portion of the hollow member  201 ; or (3) a portion of the endoscope  100 . In the illustrated embodiment, the fastener  212  comprises an adhesive patch  212  that is configured to adhere to the surface of the band strip  207 . Although not shown, the adhesive patch  212  preferably is covered with a release liner before the channeled sleeve  200  is slipped onto the endoscope. Additionally, the fastener can take other forms, such as, for example, but without limitation, a snapping, latching or hook/loop device. 
         [0042]    The band strip  207  is used to secure the hollow member  201  onto the distal end  103  of the endoscope  100  by wrapping the band strip  207  around the hollow member  201 , thereby preferably forming a seal between the hollow member  201  and the endoscope  100  such that fluid and other materials are prevented from entering into the hollow member  201 . The adhesive patch  212  preferably adheres onto a portion of itself, which has been tightly wrapped about the endoscope  100  and the hollow member  201 . In some embodiments, the adhesive may be selected to be somewhat releasable to facilitate removal of the sleeve  200  from the endoscope  100 . In other embodiments, the adhesive can form at least a semi-permanent joint, in which case the band  207  and/or hollow member  201  can be cut to remove the sleeve  200  from the endoscope  100 . 
         [0043]    The band strip  207  is constructed of any flexible material, such as plastic, polymer, or the like, and may have at least one textured surface for engaging the hollow member  201  so as to grip onto the hollow member  201 . The band strip  207  in the illustrated embodiment is formed of the same flexible materials of which the hollow member  201  is made. In other embodiments, the band strip  207  can be formed of other flexible material that may or may not be substantially elastic (e.g., a stretchable band) or the band strip  207  can be a string or like material suitable for tying or securing the hollow member  201  onto the distal end  103  of the endoscope  100 . 
         [0044]    In this preferred embodiment, the hollow member  201  lacks any significant columnar strength and/or radial strength such that the hollow member  201  will flex, bend and collapse when a force, which is sufficient to advance the endoscope into a patient&#39;s body, is applied. The hollow member  201  is configured to neither translate axial forces along the length of the hollow member  201  nor exert a radial force on surrounding body tissue. Additionally, the hollow member  201  is compliant both longitudinally and radially. 
         [0045]    The thickness of the wall of the hollow member  201  can be at least an order of magnitude smaller in size than the inner size (e.g., diameter) of the hollow member  201 . In some embodiments, the wall thickness of the hollow member  201  is at least two to five orders of magnitude smaller in size than the diameter of the hollow member  201 . In the illustrated embodiment, the diameter of the hollow member  201  is about 20 mm; however, in other embodiments, the diameter of the hollow member  201  can range between 1 mm and 20 mm, or be even smaller. The wall thickness of the hollow member  201  is preferably thin relative to the diameter of the hollow member (e.g., approximately 0.02 mm) so as to only minimally increase the profile of the endoscope device and to not affect the flexibility of the endoscope  100  by any meaningful degree. The thickness of the hollow member  201  can be less than 2 mm in some embodiments, preferably less than 0.5 mm, and more preferably is less than 0.1 mm (e.g., 0.03 mm). 
         [0046]    One or more channels  213  of the sleeve  200  are created by one or more outer members  215  attached to the hollow member  201 . In the illustrated embodiment, the sleeve  200  includes one outer member  215  having a length that is shorter than the length of the hollow member  201 . In this manner, at least the distal end of the hollow member  201  remains exposed for attachment to the endoscope  100 . In other embodiments, however, portions of the outer member&#39;s distal end can be fastened to the endoscope  100  (along with or without the distal end of the hollow member  201 ). 
         [0047]    The outer member  215  preferably has a similar cross-sectional shape to that of the hollow member  201 , although in some embodiments, the outer member  215  and the hollow member  201  can have differing cross-sectional shapes. The inner size of the outer member  215 , in the illustrated embodiment, is also larger than that of the hollow member  210 , but need not be in all embodiments as explained below. 
         [0048]    The wall thickness of the outer member  215  is preferably thin relative to the diameter of the hollow member (e.g., approximately 0.02 mm) so as to only minimally increase the profile of the endoscope device and to not affect the flexibility of the endoscope  100  by any meaningful degree. The thickness of the outer member  215  can be less than 2 mm in some embodiments, preferably less than 0.5 mm, and more preferably is less than 0.1 mm (e.g., 0.03 mm). 
         [0049]    In some preferred embodiments, the hollow member  210  and the outer members  215  are formed or extruded as one integrally formed device without any bonding joints or the like. 
         [0050]    In other preferred embodiments, the outer member  215  is fastened to the hollow member  201  preferably at a number of locations. In the illustrated embodiment, as best seen in  FIGS. 3-5 , four longitudinally extending bonds  214  join the outer member  215  to the hollow member  201  to form four channels  213 . Each channel  213  has a sufficient size to receive one or more instruments used in an endoscopic procedure (e.g., a NOTES procedure). While the bonds  214  preferably seal each channel  213  from the adjacent channels  213 , the bonds  214  can be interrupted along their length to provide at least some fluidic communication between some or all of the channels  213 . Such openings between the channels  213  may also provide different routing paths for instruments passed through other embodiments of the sleeve. 
         [0051]    As seen in  FIG. 4A , the channels  213  preferably lie in a generally collapsed state before use.  FIG. 4B  is an enlarged view of the inset area encircled in  FIG. 4A . ( FIGS. 4A and 4B  exaggerate the opening degree of the channels  213  in the collapsed state to allow the channels  213  to be identified.) This configuration minimizes the profile of the sleeve  200  when it is attached to the endoscope  100  and is inserted into a patient&#39;s body. Once the distal end  103  of the endoscope  100  is positioned at a desired location within the patient&#39;s body, the physician can insert one or more instruments  500  into the channels  213  of the sleeve. Insertion of the instruments causes the channels to expand, as illustrated in  FIG. 5 . Such enlargement of the channels  213  can occur as a result of folded material unfolding to create the expanded channel space, and/or as a result of the material stretching. The channels  213  may also be enlarged by introducing a fluid (e.g., saline) into the channel, which might occur before the physician introduces an instrument  500  into the channel  213 . 
         [0052]    As best seen in  FIG. 6A , the distal ends  216  of channels  213  are initially open, although in a collapsed state before being used. An instrument  500  or a fluid can thus freely pass through the open distal end  216  of the channel  213 . In other embodiments, as illustrated in  FIG. 6B , one or more of the distal ends  216  can be initially closed (for example by sealing at least a portion of the outer member&#39;s distal end to the distal end of the hollow member  201 ). Either a stylet or the instrument itself can be used to pierce the distal end  216  of the channel  213  to open the channel to the surgical site. In connection with embodiments having closed distal ends  216 , a fluid (e.g., saline) can be used to form a gas seal, either during the insertion process or during a surgical procedure, before the channel  213  is used. Additionally, in some embodiments, the proximal ends  217  of channels  213  are configured to connect to a negative pressure or vacuum source that is readily available at the patient facility. Negative pressure or a vacuum can also be applied to the proximal ends  217  of channels  213  having closed distal ends  216  so as to collapse the channels  213 . Collapsing channels  213  having open distal ends  216  by applying negative pressure or a vacuum is also possible in some circumstances. 
         [0053]    In use, the proximal ends  217  of the channels  213  are also sealed to inhibit the flow of fluids from the body through the channels  213 . In some embodiments, the proximal ends  217  are initially sealed and in other embodiments the proximal ends  217  are initially open. In the illustrated embodiment shown in  FIG. 3 , the proximal ends  217  are initially open. 
         [0054]    A sealing device is to be used to seal the proximal ends  217  of the channels  213  while allowing the introduction of an instrument  500 . In the illustrated embodiment, the sealing device comprises a split clamp or a split clip  219 , which is illustrated in  FIG. 7A  in a position about the endoscope  100  and the proximal end of the sleeve  200 . ( FIG. 7A , like  FIG. 4 , exaggerates the opening degree of the channels  213  in the collapsed state to allow the channels  213  to be identified.) The clip  219  surrounds all or substantially all of the circumference of the sleeve and applies an inward pressure to seal the proximal ends  217  of the channels  213 . 
         [0055]    The clip  219  in this preferred embodiment comprises a semi-rigid portion  701  that is sufficiently flexible to attach or snap-on to the endoscope  100  positioned within the sleeve  200 . The split clip  219  further comprises a compressible portion  703  that is sandwiched between the semi-rigid portion  701  and the endoscope  100  thereby sealing the hollow member  201 . The compressible portion  703  can be formed of materials which have a suitable elasticity and compressibility, including, but not limited to, Kraton® polymer compounds, such as Dynaflex® G2706 available from GLS Corporation, as well as other thermoplastic elastomers or silicone or urethane epoxies. The inner surface of the compressible portion  703  will thus conform to the surface of the sleeve  200  and any instruments inserted into the sleeve channels  213 . The compressible portion  703  flexes to allow the outer member  215  to open, expand or uncompress when a medical instrument  500  is positioned within the outer member  215 . 
         [0056]      FIG. 7B  illustrates a variation of the split ring  219   a . (Like components between the embodiments of the split ring illustrated in  FIGS. 7A and 7B  have been designated with like reference numerals with an “a” suffix added to the reference numeral indicating the elements of the embodiment shown in  FIG. 7B ). The split ring  219   a  includes a compressible portion  703   a  that is molded around rigid dimples  705 . The dimples project inward from the semi-rigid portion  701   a . In a preferred form, the dimples and the semi-rigid portion are integrally molded of a relative hard plastic, and the compressible portion  703   a  is formed of a suitable material, such as a Kraton® polymer, as noted above. The dimples  705  and the compressible portion  707  act to seal the proximal portions  205 ,  217  to the endoscope  100  while allowing medical instruments  500  to pass between adjacent dimples  705 , inside the compressible portion  703   a  and into the outer member  215 . In the illustrated embodiment, one of the dimples generally corresponds with the split  707  in the ring  219   a  with the other dimples spaced apart by a distance corresponding to the spacing between the bonds  214  on the sleeve  200 . In other embodiments, one or more of the dimples can be shaped (e.g., have a concave inner surface) and can back the compressible portion  703   a  at one or more locations that correspond to the position of the channels  213 . Accordingly, the number of channels  213  and the number of dimples  705  need not correspond, nor do all of the dimples  705  need to have the same configuration. 
         [0057]    In this manner, the outer members  215  can be substantially sealed so as to prevent or substantially limit the flow of fluid, gas or other materials through the channels  213 . In this preferred embodiment, the hollow member  201  is formed by forming or extruding an elastomeric material, such as silicone or a polymer, through a die or other similar device configured to form the hollow member  201 . The outer member  215  can be integrally formed with the hollow member  201  during this process, or can be joined onto the hollow member  201  by a conversion process. In this later process (as shown in  FIG. 8 ), the outer member  215  is joined to the hollow member  201  by inserting the hollow member  201  onto a tube  1201 , and then placing the outer member  215  around the hollow member  201 . The outer member  215  is then fused, adhered or otherwise coupled to the hollow member  201  at the bonds  214  to define one or more channels  213 . In other embodiments, multiple outer members  215  can be attached to hollow member  201 , as shown in  FIG. 9 , by coupling (e.g., fusing or adhering) the longitudinal side of each outer member  215  onto the hollow member  201 . 
         [0058]    In the preferred embodiments wherein the channeled sleeve  200  is integrally formed, the hollow member  201  and the outer member  215  are integrally formed by a dipping process, where the hollow member  201  is first formed by dipping a die of similar configuration to the cross-section shown in  FIG. 4A  into a liquid polymer, latex, polyurethane, or other bath and then removing and cooling the integrally formed channeled sleeve. In the preferred embodiments wherein the channeled sleeve  200  is formed by fastening the outer member  215  to the hollow member  201 , the outer member  215  is formed by a separate dipping process than from the hollow member  201 . The outer member  215  is formed onto the hollow member  201  through a similar dipping process using additional dies to form each channel. 
         [0059]      FIG. 10  illustrates a preferred method of using the channeled sleeve  200  wherein a split clip  219 , as illustrated in  FIGS. 7A and 7B , is attached to the endoscope  100  thereby securing the proximal end  205  of the channeled sleeve  200  to the endoscope  100 , and forming a seal such that gases, fluids, and other materials are prevented from flowing proximally from the hollow member  201  and the outer member  215 . For the split clip  219  as illustrated in  FIG. 7A , the seal is formed when compressible portion  703  and the channeled sleeve  200  are sandwiched between the semi-rigid portion  701  of the split clip  219  and the endoscope  100 . For the split clip  219   a  as illustrated in  FIG. 7B , the seal is formed when compressible portion  703  and dimples  705  are sandwiched with the channeled sleeve  200  against the endoscope  100  by pressure from the semi-rigid portion  701 . 
         [0060]    As schematically shown in  FIG. 10 , a medical instrument  500  is inserted into the proximal portion  217  of the outer member  215 , thereby creating a sealed opening by compressing/displacing the compressible portion  703  within the split clip  219 . When positioning the medical instrument  500  within the outer member  215 , the compressible portion  703  conforms around the medical instrument  500 , thereby forming a seal around the medical instrument  500  and the endoscope  100 , such that gases, fluids, and other materials are prevented from flowing proximally from the channeled sleeve  200 , including the outer member  215 . 
         [0061]    Once the physician has inserted the medical instrument  500  into the proximal portion  217  of the outer member  215 , the physician can then advance the medical instrument  500  through the outer member  215 , which causes the outer member  215  to transition from the collapsed/compressed state (as illustrated in  FIG. 4 ) to the expanded/uncompressed state (as illustrated in  FIG. 5 ). The foregoing method is repeated for other medical instruments  500  to be placed in the channels  213  formed by the outer member  215  (or, in other embodiments, by other outer members  215 ). 
         [0062]    In this preferred embodiment (as illustrated in  FIG. 6A ), the outer member  215  is open at the distal portion  216 , such that when the band strip  207  is wrapped around the channeled sleeve  200 , the outer member  215  is not occluded. In order to position the medical instrument at the surgical site, the physician axially traverses the medical instrument  500  through the outer member  215  and through the opening at the distal portion  216 . 
         [0063]    In some other preferred embodiments, an example of which was discussed above in connection with  FIG. 6B , the outer member  215  is initially sealed. In such embodiments, the physician pushes the medical instrument  500  through the wall of the outer member  215  after the medical instrument  500  has reached the distal portion  216  of the outer member  215 , thereby allowing the medical instrument  500  to be advanced into the surgical field. 
         [0064]    An advantage of the channeled sleeve  200  is the ability to insert multiple medical instruments through the various channels  213  that are a part of the channeled sleeve  200 , thereby providing multiple medical instruments with simultaneous access to the surgical site without having to replace or substantially reconfigure the physician&#39;s existing endoscope device  100 . In this regard, endoscopic surgery (for example, a NOS or NOTES procedure) is made safer and more efficient because physicians need not repeatedly remove and insert various medical instruments  500  down the single channel  107  provided in the endoscope  100 . 
         [0065]    In the illustrated embodiment, as noted above, the physician may attach a vacuum or negative pressure source, which is readily available at the patient facility, to the proximal end  217  of the channels  213  to collapse the channels  213 . By collapsing the channels  213 , the physician may more freely remove or re-position the endoscope  100  and channeled sleeve  200  within the body. In other preferred embodiments, the physician may use channels  213  as a means for removing gas, fluid, tissue, or other materials from the body by applying a vacuum or negative pressure source to the channels  213 . The physician may collect the extracted materials in a collection bag positioned at the proximal ends  217  of the channels  213  for further analysis and diagnosis. 
         [0066]    In the illustrated embodiment, as noted above, the channeled sleeve  200  is easily removed (thus releasable) from the endoscope by removing the split clip  219  from the proximal portions  205 ,  217 , and cutting the string or disengaging the band strip  207  from the distal portions  203 ,  216  by unwrapping the band strip  207  from the endoscope  100  and the hollow member  201 . Some pulling force will be required to overcome the adhesion provide by the adhesive patch  212 . The endoscope  100  is then withdrawn from the hollow member  201 , and the single-use channeled sleeve  200  requires no cleaning because it is disposed after one use. In other preferred embodiments, the channeled sleeve  200  is removed from the endoscope  100  by cutting off the hollow member  201  or at least the distal portion thereof. 
         [0067]      FIG. 11  illustrates another preferred method of using the channeled sleeve  200  wherein a proximal port  800  is inserted into the proximal portion  217  of the outer member  215 , thereby forming a seal between the port  800  and the outer member  215  such that gas, fluid and other materials are inhibited from flowing proximally from the outer member  215 . As illustrated, the channeled sleeve  200  preferably is positioned onto the distal housing portion  108 . In this preferred embodiment, a split clip, split two piece clamp, or the like is not necessary to fix and seal the channeled member  200  to the endoscope because the tapered distal housing portion  108  forms a seal with the channeled sleeve  200  when the channeled sleeve  200  is positioned and stretched over the distal housing portion  108 ; however, in other embodiments a band, string, strip, split clip, or adhesive (as the foregoing are described herein), or other like fasteners, can be used to hold (as well as preferably seal) the proximal end  205  of the sleeve  200  to the distal housing portion  108 . Additionally, the sleeve  200  need not extends onto the distal end  108  of the endoscopes hand piece  105 . The clip, band or like fastener can engage the proximal portion  104  of the endoscope body rather than the hand piece  105 . 
         [0068]      FIG. 12  illustrates the proximal port  800  as a substantially cone shaped or conical device wherein the narrow distal end  901  of the proximal port  800  is configured to be inserted into the proximal opening  217  of the outer member  215 , and the wide proximal end  903  of the proximal port  800  is configured to receive a medical instrument  500 . An internal seal (such as a septum seal or duck bill valve, as both are disclosed in, for example, U.S. Pat. No. 5,209,737 and U.S. Pat. No. 6,997,931, and both are hereby incorporated by reference in their entirety) is provided within the port  800 , thereby preventing lost of insufflation at the distal end of the channeled sleeve  200  when the port  800  is inserted into the outer member  215 . When a medical instrument  500  enters and traverses the channel  213  within the outer member  215  the internal seal maintains the seal around the medical instrument  500 , and prevents lost of insufflation at the distal end of the channeled sleeve  200 . 
         [0069]    In use, a physician inserts the medical instrument  500  through the proximal port  800  and into the proximal portion  217  of the outer member  215 . As the physician axially traverses the medical instrument  500  through the outer member  215 , the outer member  215  transitions from a collapsed/compressed state (as illustrated in  FIG. 4 ) to an expanded/uncompressed state (as illustrated in  FIG. 5 ). Advancement of the instrument into the surgical field is accomplished in the manners described above. Additionally, a proximal port  800  can be used with each channel proximal open  217  to seal the proximal ends of the channels  213 . Alternatively, the proximal ends of the channels  213  can be initially closed and the distal end  901  of the port  800  can pierce the outer member  215  to be inserted into the corresponding channel  213 . (An opening into the channel  213 , through which the distal end  901  can be inserted, can be formed in other manners as well.) In either case, the ports  800  can be a reusable item, which is cleaned and/or sterilized after each use, or be a disposable item, which is discarded along with the channeled sleeve after use. 
         [0070]    In the above-described embodiments, the one or more channels  213  of the member  200  can be formed by a single outer member  215  with multiple (e.g., four) longitudinally extending bonds that join the outer member  215  to the hollow member  201 , as illustrated in  FIG. 8 . Alternatively, the one or more channels  213  can be formed using multiple outer members  215 . Each outer member can have a strip-like shape before attachment to the hollow member  214  (e.g., the embodiment illustrated in  FIG. 9 ) or can have a tubular-like shape of a cross-section size larger or smaller than that of the hollow member  201 . 
         [0071]      FIG. 13  illustrates another embodiment of the channeled sleeve. In this embodiment, multiple channels  213  are replaced by a single channel  213  that is configured to allow multiple medical instruments  500  to axially traverse the outer member  215  as illustrated in  FIG. 13 . In this embodiment, the channeled sleeve  200  comprises a single longitudinally extending bond between the hollow member  201  and the outer member  215 . 
         [0072]    In other preferred embodiments of the present invention, the band strip  207  is substituted with a band structure that is positioned at the distal portions  203 ,  216  and that is separate from the hollow member  201 . According to this preferred embodiment, after the channeled sleeve  200  is positioned onto the endoscope  100 , the channeled sleeve  200  is secured to the endoscope  100  by releasably positioning the band structure over the channeled sleeve  200  to releasably engage the endoscope  100 . The band structure can be elastic and stretched over the endoscope and distal portion  203  of the sleeve, or can be wrapped around the sleeve in a manner similar to that described above. 
         [0073]    In other preferred embodiments, the band strip  207  is replaced by other securing means. For example, in some preferred embodiments the channeled sleeve  200  is secured to the endoscope  100  by configuring the hollow member  201  to comprise a tapered distal portion  1401 ,  1501 , as illustrated in  FIGS. 14 and 15 . In these foregoing preferred embodiments, the channeled sleeve  200  is releasably secured to the endoscope  100  when the endoscope  100  is positioned in the tapered distal portion  1401 ,  1501 . Because the diameter of the tapered distal portions  1401 ,  1501  is configured to be smaller than the diameter of the endoscope  100 , a radial inward pressure is applied by the tapered distal portion  1041 ,  1501  to engage the endoscope  100  thereby releasably securing the channeled member  200  to the endoscope  100 . The tight fit caused by stretching the materials of the hollow member&#39; distal end  203  as the endoscope  100  is inserted also forms a sufficient seal between the endoscope  100  and the hollow member  201 . 
         [0074]    In other preferred embodiments, the band strip  207  is substituted with a split clip, or the like, configured to releasably secure and seal the channeled sleeve  200  to the endoscope  100 . In still other embodiments, an adhesive is placed on the interior surface of the hollow member  201  so as to releasably secure and seal the channeled sleeve  200  to the endoscope  100 . 
         [0075]    In some embodiments, the length of the channeled sleeve  200  is adjustable to suit the working length of the endoscope  100 . In accordance with this preferred embodiment,  FIG. 16  illustrates a channeled sleeve  200  comprising perforated areas  1001  for adjusting the working length of the channeled sleeve  200 . In some preferred embodiments, the channeled sleeve  200  is stored in a spindle  1003  wherein a physician can withdraw a channeled sleeve  200  of a certain length and then remove excess portions thereof by tearing the channeled sleeve  200  along a perforated area  1001 . 
         [0076]    The channeled sleeve  200 , or at least the channels  213  (and thus the outer member  215 ), has a length that is at least substantially co-extensive with the working length of the endoscope  100 . In some preferred embodiment, the working length of the channeled sleeve  200  is the distance from the endoscope distal portion  103  along the length of the shaft of the endoscope  100  to a point that remains outside the body in use. In still other preferred embodiments, the length of the channeled sleeve  200  is the full length of the endoscope  100 . In this manner, access to the proximal ends of the channels  213  is maintained even when the endoscope  100  is fully positioned within the patient&#39;s body. 
         [0077]    In some preferred embodiments, the channeled sleeve  200  comprises openings to allow the existing markings  106  on the endoscope  100  to be visible to the physician. In other preferred embodiments, the channeled sleeve  200  comprises windows to allow the existing markings  106  on the endoscope  100  to be visible to the physician. In still other preferred embodiments, the channeled sleeve  200  is translucent or transparent to allow the markings  106  on the endoscope  100  to be visible to the physician. In other preferred embodiments, the channeled sleeve  200  comprises markings to indicate the position of the channeled sleeve  200  within the body. In some preferred embodiments, the channeled sleeve  200  comprises an exterior surface that is substantially smooth to substantially reduce or mitigate rough areas and/or sharp edges of the endoscope  100 . 
         [0078]    Although the inventions have been disclosed in the context of a certain preferred embodiments and examples and in the context of use with an endoscope, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and obvious modifications and equivalents thereof. In addition, while a number of variations of the inventions have been shown and described in detail, other modifications, which are within the scope of the inventions, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within one or more of the inventions. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combine with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above.