Patent Publication Number: US-2015080764-A1

Title: Disposable instrument including working channels for endoscopy

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 61/856,894, filed Jul. 22, 2013, the contents of which are incorporated in their entirety herewith. 
    
    
     TECHNICAL FIELD 
     The present invention relates to medical instruments and sleeves therefore. In particular, the present invention relates to sleeves covering endoscopes for co-delivering of the endoscope with other medical instruments. 
     BACKGROUND 
     Endoscopes are surgical instruments which enable a relatively non-intrusive visual inspection of and surgery on internal body tissues, particularly including body tissues located within the digestive tract. An endoscope includes a long flexible tubular member which is inserted, for example, into the colon through the anus or into the esophagus through the mouth or the nose. The tubular insertion member of an endoscope generally includes optical fibers and/or lenses for carrying light energy into the patient and for carrying organized visual information out of the patient. The insertion member also includes an elongate cylindrical channel for inserting a surgical instrument into the patient. 
     To improve performance, endoscopes have been optimized to best accomplish the selected purpose. As an example, endoscopes have been optimized and refined so as to provide upper endoscopes for the examination of the esophagus, stomach, and duodenum, colonoscopes for examining the colon, angioscopes for examining blood vessels, bronchoscopes for examining bronchi, laparoscopes for examining the peritoneal cavity, arthroscopes for examining joints and joint spaces, nasopharygoscopes for examining the nasal passage and pharynx, and intubation scopes for examination of a person&#39;s airway. 
     The operating tip of a surgical instrument, which is inserted through the ancillary biopsy channel of an endoscope, is controlled by a surgeon who manipulates an actuator at the proximal end of the endoscope. It is often difficult to maneuver an instrument through the channel to the proximal end. In order to better maneuver the instrument, the operation can be visually monitored via the visual feedback information provided by the endoscope. 
     One drawback to the existing methods of using an endoscope is that the functional end of the instrument is flush with the lens of the endoscope. Because of this configuration, it is difficult to see where the functional end of the instrument is located when the endoscope is at a site of operation. In many instances it is therefore necessary to insert an additional instrument into the patient to be at the correct angle to operate. The instrument is inserted into the patient&#39;s tissue blindly, with the physician hoping that the instrument will appear in the field of vision of the endoscope. This requires the use of both of the physician&#39;s hands, one for the endoscope and one for the instrument, and requires additional physicians to aid in suction or irrigation. 
     Because endoscopes are expensive instruments, they are used on multiple patients and must accordingly be cleaned after each procedure. Some endoscopes have been made with metal sheaths covering the channels; these types of endoscopes, however, pose risks to the patient&#39;s health if they are not properly sterilized. Cleaning generally entails soaking at least the distal end of the endoscope&#39;s insertion member in an antibacterial and antiviral solution. In addition, the operating channels of the insertion member are flushed, preferably with an antimicrobial cleaning solution. Such cleaning procedures require substantial amounts of time. Costs are increased, not only because of the hospital personnel time involved, but also because the endoscopes are out of use for that additional time. Moreover, there is always the risk that the cleaning is inadequate and that dangerous bacteria, viruses, or prions remaining in the endoscope may be subsequently transferred to a patient. This risk cannot be ignored in the present environment of AIDS and other dreaded diseases. 
     Disposable sheaths for endoscopes have been made in order to minimize the contamination of the endoscope, with a new sheath being put on the endoscope for each operation. This reduces the time for sterilization and the risk of infection to each patient. For example, U.S. Pat. No. 5,536,234 to Newman describes a detachable, disposable semi-flexible sheath for insertion into a patient&#39;s body. The sheath includes a plurality of channels in which to receive an endoscope for use with suction, drainage, or irrigation. However, it is difficult to insert an instrument through the semi-flexible sheath once inside the patient&#39;s tissue. 
     There is therefore a need for a sheath to protect an endoscope from contamination that also allows for easy manipulation of an instrument inside the sheath. There is also a need for an instrument that can easily be seen in the field of vision of the endoscope. Finally, there is a need for an instrument and sheath combination that can enable the physician to use one of their hands to perform other functions. 
     SUMMARY OF THE INVENTION 
     The present invention provides a disposable sleeve for covering an instrument including a body having a distal end and a proximal end, and includes an embedded instrument within the body in an instrument entrapment portion defining a longitudinal axis and at least one passageway extending substantially parallel to the longitudinal axis for receiving at least one additional instrument. The present invention also provides an instrument embedded in a sleeve including a body having a distal end and a proximal end. A sleeve is provided including a body having an instrument entrapment portion with a disposable instrument embedded therein defining a longitudinal axis, and at least one passageway extending substantially parallel to the longitudinal axis. A disposable sleeve is provided for covering an instrument including a body having a distal end and a proximal end, and includes a trough or a ridge on the body defining a longitudinal axis, an instrument fixedly attached to the trough or ridge, and at least one passageway extending substantially parallel to the longitudinal axis for receiving an additional instrument. Also provided are a methods of covering an instrument with a sleeve, performing a medical procedure, performing sonotubometry, injecting steroids to prevent scarring, and filtering cavities by using the sleeve and instrument combination. 
    
    
     
       BRIEF DESCRIPTION ON THE DRAWINGS 
       Other advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein: 
         FIG. 1  is a perspective view of a sleeve of the present invention with an embedded instrument retracted; 
         FIG. 2  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve with one passageway showing a longitudinal axis; 
         FIG. 3  is a perspective view of a sleeve with an embedded instrument extended; 
         FIG. 4  is a cross-sectional view of  FIG. 1  taken along line B-B; 
         FIG. 5  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve on an endoscope that is curved; 
         FIG. 6  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve on an endoscope showing the functional end of the disposable embedded instrument in the field of vision of the endoscope; 
         FIG. 7  is a cross-sectional view of  FIG. 1  taken along line B-B showing a sealed distal end of the passageway; 
         FIG. 8  is a perspective view of a sleeve showing a second passageway with an additional instrument; 
         FIG. 9  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded disposable speaker for use in sonotubometry; 
         FIG. 10  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded fluid injection needle; 
         FIG. 11  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded filtration device embedded in a second sleeve; 
         FIG. 12  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded cautery end, ultrasound probe, or radiofrequency probe; 
         FIG. 13  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded knife; 
         FIG. 14  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded balloon shown both deflated and inflated; 
         FIG. 15  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with an embedded speaker with electromyographic recording electrodes, a pressure/airflow transducer, and a balloon for use in Eustachian tube studies; 
         FIG. 16  is a cross-sectional view of  FIG. 1  taken along line A-A of a sleeve and endoscope combination with multiple embedded instruments; 
         FIG. 17  is a perspective view of a sleeve with a longitudinal trough and a fixed instrument; 
         FIG. 18  is a cross-sectional view of  FIG. 17  taken along line C-C of a sleeve with a longitudinal trough; 
         FIG. 19  is a perspective view of a sleeve with a longitudinal ridge and a fixed instrument; and 
         FIG. 20  is a cross-sectional view of  FIG. 19  taken along line E-E of a sleeve with a longitudinal ridge. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention provides a disposable sleeve for use in. covering an instrument, preferably an endoscope. It is particularly useful in endoscopic surgery. 
     Like structure among the several defined embodiments are indicated by primed numbers. 
     A “sleeve” is an enveloping structure, and is also used interchangeably with “sheath.” A sheath is used to cover and protect an endoscope and other instruments from contamination during surgery. 
     The term “embedded” . means inserted as an integral part of the surrounding whole. For example, an instrument is embedded in a sleeve, meaning that the instrument is inserted inside the sleeve and is an integral part of it. 
     The term “instrument” means a device used to facilitate work. In the present invention, the instrument is one that is used in a medical procedure. The instrument can be any suitable medical instrument, including, but not limited to, an endoscope. 
     The term “embedded instrument” generally refers to an instrument embedded in a sleeve that can be manipulated from outside the sleeve to perform a function inside a patient&#39;s body and is further detailed below. 
     The term “additional instrument” refers to an instrument that is not embedded in the sleeve and is generally freely able to be inserted and withdrawn within the sleeve, The additional instrument is preferably an endoscope, but can be any other suitable instrument, and is further detailed below. 
     The present invention provides a disposable sleeve shown generally at  10  for covering an instrument as shown in  FIGS. 1 and 3 . The sleeve  10  includes a body  12  having a distal end  14  and a proximal end  16  opposite the distal end  14 . The body  12  includes an embedded instrument  18  that is embedded within the body  12  in an instrument entrapment portion  20 . The instrument entrapment portion  20  defines a longitudinal axis  22 , as shown in  FIG. 2 . There is at least one passageway  24  that extends substantially parallel to the longitudinal axis  22  which receives an additional instrument  25 . 
     The body  12  can be formed as a thin material, but the body  12  can include thicker areas around passageways and especially around the instrument entrapment portion  20 , as shown in  FIG. 4 . There can be a bump, protrusion, or thickened area  48  on the body  12  indicating where the embedded instrument  18  is located. The bump  48  is preferably less than a few millimeters above the surface of the body  12 . The size of the bump  48  will be dependent on the thickness of the embedded instrument  18  and the type of material used for the body  12 . However, the bump  48  will result in a minimal increase in the thickness of the body when compared to prior art devices. 
     Preferably, the body  12  is made from a semi-flexible plastic, elastomeric material, vinyl or other polymer, polytetrafluoroethylene (such as Teflon®), or any other material appropriate for the particular application. The material is preferably biocompatible and complies with Federal Drug Administration (FDA) and International Organization for Standardization (ISO) requirements, and therefore does not cause toxicity or irritate the tissue with which the body  12  comes into contact. Preferably, the material is inexpensive and disposable. 
     Preferably, the additional instrument  25  is an endoscope  44 . Use with a flexible endoscope  44 , such as a fiber optic endoscope  44 , as shown in  FIG. 5 , requires that the sleeve to be able to move with the endoscope  44 , so a flexible or semi-flexible material is preferably used, such as a flexible fiber. A flexible material also allows for easier insertion of an instrument, either an embedded instrument  18  during the manufacturing process or an additional instrument  25  during a medical procedure, especially one that does not have a constant cross-sectional area because of protrudements. Use with a rigid endoscope  44 , as shown in  FIG. 6 , allows for a more rigid material to be used for the body  12 , such as a rigid fiber or other rigid material capable of being used in this manner. 
     An instrument entrapment portion  20  extends between the distal  14  and proximal  16  ends of the body  12  and includes the embedded instrument  18  extending along a length of the instrument entrapment portion  20 . The instrument entrapment portion  20  includes a distal end  32  and a proximal end  19 . A cross-sectional diameter D of the instrument entrapment portion  20  is preferably circular; however, it can also be other shapes as required for use. For example, the cross-sectional diameter D can be a custom shape to fit a particular embedded instrument  18 , The size of the cross-sectional diameter D can vary depending on the embedded instrument  18  desired to be inserted in the sleeve  10  during manufacturing. Preferably, the cross-sectional diameter D is small, and more preferably smaller than the cross-sectional diameters of other passageways  24  in the sleeve. The instrument entrapment portion  20  is not designed as a passageway itself, but is instead a place for the embedded instrument  18  to rest inside the body  12 , It is also desirable to be able to maneuver the embedded instrument  18  while in the instrument entrapment portion  20 , therefore the size of the cross-sectional diameter D of the instrument entrapment portion  20  preferably permits slight movement of the embedded instrument  18 . Preferably, there is not much space between an inside surface  21  of the instrument entrapment portion  20  and an outer surface  23  of the embedded instrument  18  because it is not desirable to have bodily fluids escape down the instrument entrapment portion  20 . 
     The passageway  24 , in which the additional instrument  25  is inserted, also extends along the length of the body  12  of the sleeve  10  from the distal end  14  to the proximal end  16 . The passageway  24  includes an open proximal end  41  and a distal end  42 . Depending upon the use of the passageway  24 , it can include either a closed distal end  42 ′ shown in  FIG. 7 , or an open distal end  42 ″, as shown in  FIG. 4 , For example, when an endoscope  44  is inserted into the passageway  24 , it is preferred that there is a closed distal end  42 ′, which can be closed by an end cap  45 . The end cap  45  can be integral with the body  12  or it can be made separately, with the same or different material as the body  12 , and sealably attached to the body  12  to make a closed distal end  42 . Furthermore, with the use of an endoscope  44 , the end cap  45  is preferably an optically transparent cap  45 ′ so as not to block the vision of the endoscope  44 . An optically transparent cap  45 ′ allows for endoscopic visualization in a patient when the endoscope  44  is inserted in the sleeve  10 . The optically transparent cap  45 ′ can be a clear lens. The optically transparent material can be, but is not limited to, clarified polypropylene, polyethylene terephthalate, polystyrene, polyvinyl chloride, polycarbonate, and glass. 
     The passageway  24  has a cross-sectional diameter D2 like that of the instrument entrapment portion  20 . The cross-sectional diameter D2 shape and size are appropriate for the particular additional instrument  25  inserted into the passageway  24  and can be variable with respect to the instrument being inserted. For example, with the endoscope  44 , the cross-sectional diameter D2 is a circular shape to accommodate the elongated insertion member  50  of the endoscope  44 , and the size of the cross-sectional diameter D2 is small enough so that the endoscope  44  is not moving freely inside the body  12 . The sleeve preferably includes no extraneous material because during use such material can be twisted, bunched, or misaligned relative to the elongated insertion member  50 . Extraneous material can also increase the diameter of the endoscope  44 , which can increase pain or discomfort to the patient. The passageway  24  is also of an appropriate length to cover the additional instrument  25 , and can be varied according to the additional instrument  25  being used. 
     The sleeve  10  can optionally include more passageways  24  for multiple instruments extending from the distal end  14  to the proximal end  16  and substantially parallel to the longitudinal axis  22 . For example, as shown in  FIG. 8 , a second passageway  38  can be included for the purpose of suction, drainage, or irrigation wherein a third instrument  26  is inserted through the second passageway  38 . The other passageways  24  can serve any other suitable purpose. 
     The embedded instrument  18  can be made from any suitable materials, such as a rigid or flexible material, by manufacturing methods known in the art. The embedded instrument  18  can be disposable along with the entire sleeve  10 . The embedded instrument  18  can be sterilized and reused in another procedure. The embedded instrument  18  is embedded in the instrument entrapment portion  20 , or in some manner fixed or fastened thereto. The embedded instrument  18  can alternatively be housed in a second sleeve  11 , which fits inside the instrument entrapment portion  20  and is in some manner fixed or fastened thereto, as shown in  FIG. 11 . 
     The embedded instrument  18  includes a functional end  28  and a manipulative end  30  opposite the functional end  28 . The functional end  28  is located at the distal end  32  of the instrument entrapment portion  20 . The functional end  28  is used to perform part of a surgical procedure. The functional end  28  can be fully encompassed by the distal end  32  of the instrument entrapment portion  20  when inserted into tissue, or it can be fully or partially protruding outside of the distal end  32  when inserted into tissue. In other words, the functional end  28  of the embedded instrument  18  can terminate at any point along the instrument entrapment portion  20  as desired. Further, the functional end  28  can protrude from the instrument entrapment portion  20  at various lengths and angles, and can be manipulated by a telescoping movement described below. 
     An elongated portion  31  operatively connects the functional end  28  and the manipulative end  30 , and extends along the length of the instrument entrapment portion  20 . For example, the elongated portion  31  can be a hollow rod containing wires along its length connected to both the functional end  28  and the manipulative end  30  that allows for the manipulation of the functional end  28  by a physician. The elongated portion  31  can also be a chamber housing a laser. The elongated portion  31  can be stiff or flexible. A flexible elongated portion  31  can be used with the flexible endoscope  44  or additional instrument  25 . The elongated portion  31  can be any other suitable design that allows for manipulation of an embedded instrument  18  from outside of the patient&#39;s tissue. 
     The manipulative end  30  of the embedded instrument  18  protrudes from the proximal end  19  of the instrument entrapment portion  20 . The manipulative end  30  is a device that the physician can manipulate to cause the functional end  28  of the embedded instrument  18  to function. Furthermore, the manipulative end  30  can be manipulated to make the functional end  28  telescope in or out of the distal end  32  of the instrument entrapment portion  20  or to rotate the functional end  28 . In  FIG. 1 , the embedded instrument  18  is shown with a retracted functional end position  36 . In  FIG. 3 , the embedded instrument  18  is shown with a protruded functional end position  34 . The telescoping can be accomplished by a motorized extension of the elongated member  31  when the physician presses a button on the manipulative end  30  of the embedded instrument  18 . Another way to accomplish the telescoping is by manipulating a tension wire  33  inside the elongated member  31  attached to the manipulative end  30 . Any other method of telescoping can be used. The telescoping ability is advantageous when the functional end  28  is sharp or has an awkward shape, so that the functional end  28  can be retracted into the distal end  32  of the instrument entrapment portion  20  in order to allow smooth movement of the sleeve  10  and additional instrument  25  combination through. tissue. When at an operating site, the functional end  28  can then be deployed out of the distal end  32  of the instrument entrapment portion  20 . 
     One advantage of the present invention is that the functional end  28  of the embedded instrument  18  is in the field of vision  46  of the passageway  24  when deployed outside of the distal end  32  of the instrument entrapment portion  20 . In other words, the functional end  28  can be viewed directly by the endoscope  44  inserted in the passageway  24 . For example, the functional end  28  can protrude 1 cm past the distal end  32  of the instrument entrapment portion  20  and inwards toward the field of vision  46  at a 30 degree angle. Any suitable protruding length or angle can be used. The embedded instrument  18  being in the field of vision of the endoscope  44  of the present invention is distinguishable from other endoscopes (with or without a sleeve) with fixed instruments, such as a laser, in one of the endoscope&#39;s channels. A fixed instrument is in direct alignment with the endoscope and does not protrude, and is therefore not in the endoscope&#39;s field of vision. There are instruments in the prior art which are not fixed, such as biopsy forceps and stone grasping baskets, and can be passed through the conventional working channel of existing endoscopes to protrude into the endoscope&#39;s field of vision. However, because the instruments have to be passed through an existing working channel, they are limited in diameter. These prior art instruments are also often excessively mobile or flexible, and therefore much harder to control than the embedded instruments  18  of the present invention. Furthermore, the diameter of the embedded instruments  18  of the present invention is not limited, and the instrument entrapment portion  20  can be designed to fit the diameter of a specific embedded instrument  18 . The ability of the embedded instruments  18  to protrude into the field of vision  46  solves the problem of trying to find a separately inserted instrument or maneuver it to the tissue site of the endoscope  44 . In the present invention, the embedded instrument  18  follows the exact path of the endoscope  44  during insertion into tissue, therefore, once the endoscope  44  is at the operative site, the embedded instrument  18  is also at the operative site, 
     The embedded instrument  18  can be used for any suitable purpose such as diagnostic uses or therapeutic uses, medical uses, surgical uses, industrial uses, or forensic uses, several of which are further detailed below. The embedded instruments  18  can be connected to devices that are powered by any means, for example, hand powered tools, electrical tools, vacuum devices, positive pressure devices, and fluid movement devices. The embedded instrument  18  can also be actively or passively mobile, steerable, or have various moving parts which are active or passive. The embedded instrument  18  can be removed from the sleeve  10  during a procedure and exchanged for a different embedded instrument  18 . The embedded instrument  18  can also be repositioned within the sleeve  10  to change the angle of the functional end  28 . 
     The embedded instrument  18  can be any instrument that allows for manipulation a length away from the functional end  28 . For example, in endoscopic surgery, the embedded instrument  28  can be a folding catheter, a dilating probe, a test probe such as for testing electrical currents in the heart, a pressure sensing device, a fluid injector, biopsy forceps, a laser, or a needle. The embedded instrument  28  can also be a laser that can be used for various purposes such as laser surgery. The embedded instrument  18  can take on many other different forms, such as, but not limited to, an electric monopolar or bipolar cautery  60 , an ultrasound probe  60 ′ or a radiofrequency probe  60 ″ shown in  FIG. 12 . The embedded instrument  18  can be a retractable injection needle  56 , an aspiration needle  56 ′, or a radiofrequency needle  56 ″, as shown in  FIG. 10 . The embedded instrument  18  can be a knife  62 , or any other sharp or blunt dissecting object, as shown in  FIG. 13 . The embedded instrument  18  can be a balloon  64 , as shown in  FIG. 14 , which can be inflated when positioned outside of the instrument entrapment portion  20 . The balloon  64  can further be used with instrumentation such as a sheath lumen, suction, diagnostic or therapeutic instruments. The embedded instrument  18  can be a measurement probe  58 ′ such as a transducer for pressure measurement, temperature measurement, Doppler probe, motion sensor, or spectroscopy as shown in  FIG. 11 . The embedded instrument  18  can be a treatment probe  58 ″ such as a laser, photodynamic Rx light, or radioactive seeds, also as in  FIG. 11 . The embedded instrument  18  can further be other sensors or stimulators such as microphones and speakers. The embedded instrument  18  can also be forceps  70 , scissors  70 ′, or any other suitable instrument for biopsy or other surgical purpose, as shown in  FIG. 6 . The embedded instrument  18  can be a combination of instruments for multiple Eustachian tube studies including the speaker  54 , electromyographic recording electrodes  66 , a pressure/airflow transducer  68 , and a balloon  64 , further detailed below. Further, multiple embedded instruments  18  can be embedded in one or more instrument entrapment portions  20 , such as the sleeve  10  shown in  FIG. 16  with the filtration device  58  and the knife  62 . Any suitable combination of instruments can be used. 
     The sleeve  10  can be packaged with the embedded instrument  18  already inside the instrument entrapment portion  20 , so the user does not need to insert additional instruments. In order to insert an additional instrument  25  through the passageway  24 , the distal end  52  of the additional instrument  25  is inserted in the proximal end  41  of the passageway  24 . The sleeve  10  is slid over the length of the additional instrument  25  until the distal end  52  of the additional instrument  25  is at the distal end  42  of the passageway  24 . During this process, the distal end  52  of the additional instrument  25  is aligned with the functional end  28  of the embedded instrument  18  and a proximal end  53  of the additional instrument  25  is aligned simultaneously with the manipulative end  30 . The sleeve  10  can also be rotated on the additional instrument  25  so as to align the embedded instrument  18  in a desired place. 
     The sleeve  10  can be used with the endoscope  44  or any other suitable medical device during a surgical procedure. For example, the endoscope  44  can be inserted in the sleeve  10  as described above and then the endoscope  44  and sleeve  10  combination is inserted into a patient&#39;s tissue to the operation site. The physician can telescope the functional end  28  of the embedded instrument  18  into the field of vision  46  of the endoscope  44  (if the functional end  28  was inside the distal end  32  of the instrument entrapment portion  20 ) and view its position with the endoscope  44 . The manipulative end  30  is manipulated so that the functional end  28  performs at least one step of the surgery. After the procedure is finished, the endoscope  44  and sleeve  10  combination can be removed from the patient&#39;s tissue. The sleeve  10  with the embedded instrument  18  are removed from the endoscope  44  and can then be disposed. The endoscope  44  is protected from contamination and is free to be used in the next procedure with minimal cleaning. 
     The sleeve  10  is advantageous in medical procedures because the sleeve  10  is an impermeable, disposable protective cover for the additional instrument  25 , it protects against exposure of the additional instrument  25  to fluids and thus protects the patient against infection. The sleeve  10  also facilitates and/or eliminates damaging cleaning of the additional instrument  25 . Another advantage of the present invention is that the sleeve  10  and endoscope  44  combination enables one of the surgeon&#39;s hands to be available. Previously, the physician used one hand for the endoscope  44  and another for a surgical instrument. This meant that an extra person was required to perform suction, drainage, or irrigation, or an endoscope holding device would be employed. However, using the sleeve  10  with an embedded instrument  18  on the endoscope  44  allows the physician to use his or her other hand to perform another procedure or hold onto another instrument. The sleeve  10  and endoscope  44  combination are coupled and steerable, so the physician knows where the embedded instrument  18  is going and can feel comfortable directing it with one hand. 
     The sleeve  10  and endoscope  44  combination is an ideal instrument for performing a sonotubometry test. A sonotubometry test is done with a speaker in a patient&#39;s nostril and a microphone in an ear that listens for an increase in the speaker&#39;s tone which occurs when the Eustachian tube opens. The test can be used to determine if the middle ear is being ventilated. Sonotubometry results currently have a great deal of background noise from the throat, and recordings are done “in the blind” without any correlation to actual visualized events within the Eustachian tube. With the use of the present invention, a Eustachian tube is recorded by video in the endoscope  44  while an embedded speaker  54  ( FIG. 9 ) in the sleeve  10  emits sounds and a microphone in the ear collects the sound after it has traveled across the Eustachian tube. In the procedure, the sleeve  10  and endoscope  44  combination is inserted in the patient&#39;s nostril to reach the Eustachian tube while a microphone is placed in the ear. The signal to noise ratio is greatly improved. The embedded speaker  54  can also include the inflatable balloon  64  to seal in the nasopharyngeal orifice of the Eustachian tube, electromyographic recording electrodes (EMGs)  66 , and a pressure/airflow transducer  68  as shown in  FIG. 15 . 
     In another procedure, the sleeve  10  and endoscope  44  combination can be used to inject a steroid into tissue to prevent scarring. The embedded instrument  18  is the fluid injection needle  56  that can be manipulated to inject steroids into the tissue site as shown in  FIG. 10 . The sleeve  10  can be applied to the endoscope  44  and, as described above, the endoscope  44  and sleeve  10  combination can be inserted in the patient to the tissue site of interest, the physician can inject the steroid with the fluid injection needle  56 , optionally by telescoping the fluid injection needle  56  out of the instrument entrapment portion  20 , and finally, the endoscope  44  and sleeve  10  combination can be removed from the tissue. 
     The sleeve  10  and endoscope  44  combination can be used to locally filter body cavities. The embedded instrument  18  can be the filtration device  58  as shown in  FIG. 11 . The sleeve  10  can be applied to the endoscope  44  as described above, the endoscope  44  and sleeve  10  combination can be inserted into the cavity wished to be flushed, the physician can manipulate the filtration device  58  to flush out the cavity (optionally by telescoping the filtration device  58  out of the first passageway), and finally, the endoscope  44  and sleeve  10  combination can be removed from the cavity. 
     The sleeve  10  and endoscope  44 /additional instrument  25  combination can also be used in many other procedures. For example, the combination can be used in laser surgery, cardiovascular surgery, ventricular surgery, or GI surgery by generally following the method of performing a surgical procedure as described above. 
     In another embodiment, the sleeve  10  can includes a fixing mechanism  71  such as a longitudinal trough  72  ( FIGS. 17 and 18 ) or a longitudinal ridge  74  ( FIGS. 19 and 20 ) on which a fixed instrument  78  can be fastened. The longitudinal trough  72 /ridge  74  extends from the distal end  14  of the body  12  to the proximal end  16  of the body  12 . The fixed instrument  78  can be fastened in any suitable way. For example, the trough  72  or the ridge  74  can be shaped to fit the fixed instrument  78 . Preferably, the fixed instrument  78  fits snugly against the trough  72 /ridge  74 . The fixed instrument  78  can be re-used and sterilized before each use. The fixed instrument  78  can be any embedded instruments  18  and can have any of the properties as described above. For example, the fixed instrument  78  can be a needle, a laser, biopsy forceps, a fluid injector, a folding catheter, a dilating probe, a test probe, or any other suitable instrument. The fixed instrument  78  can be used in a similar method as the embedded instruments  18  as described above. 
     Throughout this application, various publications, including United States patents, are referenced by author and year and patents by number. Full citations for the publications are listed below. The disclosures of these publications and patents in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains. 
     The invention has been described in an illustrative manner, and it is to be understood that the terminology which has been used is intended to be in the nature of words of description rather than of limitation. 
     Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.