Abstract:
Devices for and methods of treating afflictions occurring in a body cavity, such as the epidural space. The methods and devices provide for fluoroscopic assisted placement of a fiber optic catheter/scope with a balloon tip. These devices and methods would perform decompression surgery, neuroplasty, and mechanical lysis of adhesions (and other afflictions), as well as allowing small operating and therapeutic instruments under direct visualization.

Description:
REFERENCES TO RELATED APPLICATIONS  
       [0001]    This application claims priority from U.S. Provisional Patent Application No. 60/174,771, and PCT application No. PCT/US01/00405, the disclosures of which are incorporated herein by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention generally relates to medical devices and methods for using the same. In particular, the present invention relates to a method for treating fibrotic lesions in the epidural space of the spinal column and to a device for facilitating such a method. Specifically, the present invention relates to steerable fiberoptic catheter/scope with a balloon tip that is to be used in and around the epidural space (and other body cavities) to dilate the epidural space, decompress adhesions, and remove scar tissue.  
         BACKGROUND OF THE INVENTION  
         [0003]    Back pain, and particularly lower back pain, is a common disabling problem of the body. In the back or posterior end of the body, the epidural space is located in and extending the length of the spine. The epidural space contains fat, connective tissue, blood vessels, lymphatic vessels, nerve fibers, as well as other structures. FIGS. 9 a  and  9   b  illustrate, the crescent shaped cross-section of the epidural space  110  and its position within the spinal column  118 . The epidural space  110  is defined along the edge (or side) by dura mater  112  that surrounds spinal cord  118 . The epidural space is further defined along a second edge (or side) by the periosteum of the bony vertebrae or by ligamentum-flavum  114  at the vertebral interspaces. Along the interior surface of the periosteum or ligamentum-flavum  114  lies venus plexis  119 , a complex configuration of veins. Web-like fibrosis  120  may adhere to dura mater  112  and the periosteum and/or the ligamentum-flavum  114 . These fibrosis may be formed in a random manner or in layers that form lesions extending across epidural space  110  or parallel thereto.  
           [0004]    The various lesions, as well as cystical masses and nerve damage, which occur in and around the epidural space can cause various back problems for the human body. Fibrosis often comprise an epidural lesion, which may have a consistency ranging from very soft to tougher, scar-tissue.  
           [0005]    An epidural lesion may extend through the epidural space over the length of two or three vertebrae and are believed to be a source of lower back pain and possibly sciatica in human beings. These lesions are believed to be caused by postoperative scarring of nerves, particularly from laminectomy procedures. A ruptured disc or a leaking disc, caused by an annular tear, also are believed to be a cause. Adhesions are often attached to the nerve roots or sleeves themselves causing compression and/or tethering of these neural elements, causing intractable pain and disability. This condition is often related to post surgical changes related to inflammation or bleeding in the epidural spaces resulting in scar tissue formation with resultant contraction over time. Many other conditions can contribute to the above affliction in the epidural space, including leakage of material from the compromised inter-vertebral disc, infection, tumor, and a number of other medical conditions. The result of these afflictions is loss of the epidural space and/or inflammation in the same space. These lesions generally have their greatest negative effect when they exist in the anterior lateral epidural space.  
           [0006]    Epidural lesions and other epidural afflictions have been treated by numerous methods. One known method is surgical exploration. Unfortunately, surgical exploration is difficult, time-consuming and often results in a painful post-operative recovery.  
           [0007]    Epidural afflictions have also been investigated and treated through the methods and devices disclosed in U.S. Pat. No. 5,232,442, the disclosure of which is incorporated herein by reference. Epidural lesions also have been treated by fluid lysis. In fluid lysis, an epidural catheter often comprising a flexible tubular shaft having an open distal end is introduced between the vertebrae of the spinal column and into the epidural space. The distal end of the epidural catheter is positioned adjacent the fibrosis comprising the lesion. A desired volume of fluid is then delivered through the catheter and directed against the fibrosis with enough force to break the web-like layers comprising the lesion. Unfortunately, fluid lysis can be ineffective because the fluid takes the path of least resistance upon leaving the distal end of the catheter and fails to impact the fibrosis with enough force to destroy the lesion. Consequently the lesion is not removed and the procedure must be repeated.  
           [0008]    Fluoroscopic observation techniques have also been used to investigate and treat various sources of problems associated with back pain. See, for example, U.S. Pat. No. 5,215,105, the disclosure of which is incorporated herein by reference. These fluoroscopic techniques help guide devices, but fail to give a detailed picture of structures within vessels or cavities, such as the epidural space, and therefore are limited in their ability to identify the source of back pain. For example, fiber optic scopes (or fiberscopes) have been used for various types of surgery. These fiberscopes often are inserted into a vein or an artery for viewing blockage or the like within the vein or artery. The epidural space, however, has not fully been explored using visual techniques because the epidural space, as described above, does not take the form of a vein or artery. Instead, the epidural space collapses around an instrument or device inserted therein.  
           [0009]    Endoscopes have been used to investigate and treat internal areas or organs within a body vessel or cavity, such as the epidural space. An elongated insertable part of the endoscope is inserted through a tube or sleeve that is itself inserted into a body vessel or cavity, or directly into the body vessel or cavity itself. See, for example, U.S. Pat. No. 5,195,541, the disclosure of which is incorporated herein by reference. These endoscopes, however, are relatively large with respect to a catheter and, therefore, difficult and dangerous to operate.  
           [0010]    Practitioners have also used contrast injections under fluoroscopy to investigate and treat epidural afflictions. More recently, epidurography and/or epiduroscopy has improved diagnosis and treatment. Equipment and technology have only recently allowed epidurography to diagnose and treat these most difficult and incapacitating medical conditions. Because the epidural space is continuous with the dura and the neuro-foramina, it is the obvious starting cavity to diagnose and treat many of the epidural afflictions.  
           [0011]    Therefore, there is still a need for a device for and a method of epidural exploration and surgery that allows a physician or use to effectively enter the epidural space, visually observe a problem area, and therapeutically treat the problem area in or around the epidural space in a minimal amount of time and with minimal amount of damage.  
         SUMMARY OF THE INVENTION  
         [0012]    The present invention provides devices for and methods of treating afflictions occurring in a body cavity, such as the epidural space. The methods and devices provide for fluoroscopic assisted placement of a fiber optic catheter/scope with a balloon tip. These devices and methods would perform decompression surgery, neuroplasty, and mechanical lysis of adhesions (and other afflictions), as well as allowing small operating and therapeutic instruments under direct visualization. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    FIGS.  1 - 4 ,  5   a - 5   b ,  6   a - 6   b,    7   a - 7   d,    8 , and  9   a - 9   b  are views of medical devices and methods of using the same according to the present invention. FIGS. 4, 5 a - 5   b,    6   a - 6   b,    7   a - 7   d,    8 , and  9   a - 9   b  presented in conjunction with this description are views of only particular—rather than complete—portions of the medical devices and methods of using the same. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0014]    The following description provides specific details in order to provide a thorough understanding of the present invention. The skilled artisan, however, would understand that the present invention can be practiced without employing these specific details. Indeed, the present invention can be practiced by modifying the illustrated structural member and method and can be used in conjunction with apparatus and techniques conventionally used in the industry. For example, the devices and methods are described with reference to the epidural space and the afflictions associated therewith. The devices and methods of the present invention, however, could easily be adapted for other body cavities and their associated afflictions.  
         [0015]    The devices of the present invention are able to perform at least three functions simultaneously. First, the devices of the present invention are steerable. Second, the devices of the present invention are optical. Finally, the devices of the present invention are inflatable. By exhibiting these three functions simultaneously, the devices (and methods) of the present invention are more effective and easier to use than known devices.  
         [0016]    The devices of the present invention are made steerable using any suitable means known in the art. Suitable means include any mechanism that allows a user of the device to control the direction of the device. Examples of suitable steerable means include those described in U.S. Pat. Nos. 5,857,996 and 5,399,164, the disclosures of which are incorporated herein by reference.  
         [0017]    The devices of the present invention are made optical using any suitable means known in the art. Suitable means include any mechanism that allows a user of the device to view the proximity of the body cavity near the device. Examples of suitable optical means include those described in U.S. Pat. Nos. 5,857,996, 4,961,738, 5,399,164, and 5,215,105, the disclosures of which are incorporated herein by reference.  
         [0018]    The devices of the present invention are made inflatable using any suitable means known in the art. Suitable means include any mechanism that allows a user of the device to expand a portion of the device when desired. Examples of suitable inflatable means include balloons and the like, as well as those means described in U.S. Pat. Nos. 4,961,738, and 4,519,403, 5,084,016, and 5,215,105, the disclosures of which are incorporated herein by reference.  
         [0019]    Besides the above three functions, the devices can contain any other features known in the art which aid the devices to serve additional functions. As well, the devices of the present invention can have any configuration that provides the above three features. A preferred configuration for the devices of the present invention for achieving the above three functions is illustrated in the Figures.  
         [0020]    In the aspect of the present invention illustrated in the Figures, device  100  comprises three main portions: a disposable catheter portion, a reusable handling portion, and a connecting portion. The reusable handling portion allows an operator to hold—either by hand or by using a mechanical apparatus—device  100  and to control the device. Thus, any suitable mechanism which serves such functions can be employed in the present invention. See, for example, U.S. Pat. Nos. 5,857,996 and 5,399,164, the disclosures of which are incorporated herein by reference. Preferably, the handling portion  45  illustrated in FIG. 1 is employed in the present invention. In one aspect of the invention, the handling portion can be made disposable instead of reusable.  
         [0021]    The disposable catheter portion allows an operator to access, analyze, and treat the desired body cavity, such as the epidural space. Thus, any suitable mechanism which serves such a function can be employed in the present invention. See, for example, U.S. Pat. Nos. 5,857,996, 5,215,105, 4,519,403, and 4,961,738, the disclosures of which are incorporated herein by reference. Preferably, the catheter portion  46  illustrated in FIG. 1 is employed in the present invention.  
         [0022]    The handling portion and the disposable catheter portion are connected using a connecting portion, e.g., suitable connection means known in the art. Suitable connection means are those devices or apparatus which removably connect these two portions, yet (as described below) allow communication between these portions. Preferably, the connection portion  101  illustrated in FIG. 1 is employed in the present invention. The connecting portion can be part of or separate from either the handling portion or the catheter portion.  
         [0023]    The material for the handling portion, catheter portion, and connection portion (unless specified otherwise) can be made of any suitable medical grade material. Examples of suitable medical grade materials include polymeric materials, plastic materials, rubber materials, elastomeric materials, silastic, silicone, and PVC. Preferably, polyurethane is used in the present invention as this material.  
         [0024]    In the aspect of the present invention is illustrated in the Figures, body  45  (handling portion) is connected to catheter  46  (catheter portion) by locking collar  6  and proximal collar  7  (collectively, the connecting portion). Body  45  comprises housing  4  which contains at least one control means and at least one communication means. The control means allow a user to actuate and control the various functions of device  100 , including the three functions described above. Thus, any suitable control means known in the art can be employed in the present invention. The conveyance means allows the handling portion to convey the instructions from the control means in the handling portion to the catheter portion. Thus, any suitable conveyance means known in the art can be employed in the present invention.  
         [0025]    In one aspect of the invention, a single control means and a single conveyance means can be employed for all the functions desired of device  100 . In a preferred aspect of the invention, however, multiple control means and multiple conveyance means are used, with each control means and conveyance means controlling a single function. Thus, for example, a first control means and a first conveyance means could be used for the inflatable function, a second control means and a second conveyance means could be used for the visualization (fluoroscopic) function, etc...  
         [0026]    For example, a first control means and a first conveyance means are employed to aid in the inflatable function of device  100 . In FIG. 7 a,  trigger  12  is hinged at  49  and is connected to a pump plunger  47  and a pump  34 . Pump  34  can pump any suitable fluid  9 , e.g., a liquid such as saline solutions, water, contrast agents, pharmaceuticals, or anesthetics; a gas such as air; a gas containing a solid such as a suspension; a liquid containing a solid such as a slurry; or a gas containing a liquid. The fluid  9  is pumped from a reservoir (not shown) that is either internal or external to body  45 . Pump  34  pumps the selected fluid  9  through tube  35  and into catheter  46 . Tube  35  is made of any suitable material which will handle the selected fluid, such as plastic. Tube  35  is provided with fitting  48  that will connect tube  35  to pump  34 . Tube  35  is connected at the other end to manifold  51 . Since manifold  51  is attached to housing  4 , manifold  51  serves to anchor tube  35  to housing  4 . By actuating trigger  12 , a user is able to pump fluid  9  from the reservoir, through tube  35 , through manifold  51 , and to the catheter portion. Fluid  9  will be used, as described below, to inflate the inflatable means of device  100 .  
         [0027]    In a similar manner, additional control means and conveyance means can be provided for the additional functions desired of device  100  as shown in FIG. 7 b.  Tube  36  can also be provided for the optical function of device  100 . Tube  36  is provided in housing  4  and is connected at one end to manifold  51  and at the other end to viewing port  2 , which in one aspect of the invention is a video connection port. Tube  37  can also be provided for the optical function of device  100 . Tube  37  is connected at one end to manifold  51  and, at the other end to light source port  1 , which in one aspect of the invention is a light injection port. These tubes, along with their associated ports, aid a user to use device  100  to view the body cavity under inspection.  
         [0028]    Other control and conveyance means can be used for the steering function of device  100  as shown in FIG. 7 a.  Two triggers  5  are connected to spring loaded chamber  39  that is connected to housing  4 . Spring loaded chamber  39  is connected to attachment rod  40  that has an attachment point  102  to allow connection of a first deflection wire  24  and a second deflection wire  25 . The first and second deflection wires are not connected to manifold  51 , but instead pass through manifold  51  via ports  27 . As described below, these elements of device  100  are used to aid a user in steering device  100 .  
         [0029]    As shown in FIG. 7 b,  Tube  38  can be provided for additional functions, such as introducing other instruments or injecting other fluids. Tube  38  is connected at one end to manifold  51  and, at the other end, to port  3 , which in one aspect of the invention can serve to introduce fluids, gas, or micro surgical/therapy instruments. If desired, additional control and conveyance means can be provided for additional functions for device  100 .  
         [0030]    As illustrated in FIG. 1, body  45  contains manifold  51 , which secures the conveyance means within handling portion. The control means of the handling portion are already affixed thereto, so there is no need to secure them The conveyance means (tubes and wires), however, are attached to the control means at one end and therefore need to be secured to manifold  51  at their other end. Manifold  51  is also connected to tubes  35 ,  36 ,  37 ,  38  (and others, if desired) so as to allow materials associated with that respective tube to pass through manifold  51  and into the catheter portion. Any suitable connection which allows such a transfer can be employed in the present invention. One suitable connection is indexing ports  41 ,  42 ,  43 ,  50  as illustrated in FIGS. 7 c  and  7   d  that are respectively associated with tubes  35 ,  36 ,  37 , and  38 , and serve as an “end” to the tubes, and allow the materials to pass through manifold  51 .  
         [0031]    As shown in the Figures, connection portion between handling portion and disposable catheter portion comprises several elements besides the connection means which aid in the operation of the device. Connection portion comprises locking collar  6  and proximal collar  7 . These two collars serve to removably connect handling portion and catheter portion using any suitable mechanism known in the art. For example, proximal collar  7  which has previously been attached to catheter  46 —can be screwed onto body  45  using locking collar  6  and threads  52 , thereby removably connecting the handling portion with the catheter portion as shown in FIGS. 7 a  and  7   b.  In this process of connection, manifold  51  that is located in body  45  abuts to manifold  30  that is located in proximal collar  7  as shown in FIG. 6 a.    
         [0032]    As depicted in the Figures, proximal collar  7  contains manifold  30  which serves a similar function as manifold  51 . Manifold  30  also contains indexing ports  31 ,  32 ,  33 , and  53  that serve the same functions as the indexing ports  41 ,  42 ,  43 , and  50 , but are merely located in manifold  30  instead of manifold  51 . When attached to locking collar  6  (which is connected to body  45 ), manifold  30  abuts manifold  51  with the indexing ports of manifold  30  matched with the corresponding indexing ports of manifold  51 .  
         [0033]    As illustrated in the Figures, the combination of the two sets of indexing ports allows materials in the tubes located in the handling portion to pass into the catheter portion. The fluids and light from tubes  35 ,  36 ,  37 , and  38  pass through the indexing ports in manifold  51 , through the index ports of manifold  30 , and to the catheter portion. Manifold  30  is connected to tubes  54 ,  55 ,  56 ,  57  as described below. Thus, the materials associated with that respective tube to pass through manifold  51 , through manifold  30 , and into matching tubes in the catheter portion.  
         [0034]    As shown in FIG. 8, connecting portion contains means for aligning the handling portion and the catheter portion. One suitable aligning means is indexing lug  44 , which makes sure catheter portion is aligned properly with the handling portion. Indexing lug  44  also makes sure that manifold  51  is aligned properly with manifold  30 . Indexing lug provides the alignment by indexing with slot  28  in a proximal collar  7  as shown in FIGS. 5 a  and  6   a.    
         [0035]    If necessary, sealing means-such as gaskets-an be provided in device  100  where necessary. For example, as shown in FIGS. 5 a  and  6   a,  manifold  30  is provided with gasket  29  that seals a injection index port  33  from leaking when fluids or materials are passed through it. In another example, gasket  154  can be provided for port  53  from leaking when fluids or materials are passed through it. Additional gaskets for the other indexing ports, and other parts of device  100 , can be added where necessary.  
         [0036]    As shown in FIGS. 5 b  and  6   b,  catheter portion comprises catheter shaft  8  which contains at least one conveyance means. The conveyance means allows the catheter portion to convey the materials from the handling portion through manifold  30  to the respective location of the catheter portion where these materials perform the desired operation. Thus, any suitable conveyance means known in the art can be employed in the present invention. In one aspect of the invention, tubes  54 ,  55 ,  56 ,  57  are employed as the conveyance means in the catheter portion (similar to tubes  35 ,  36 ,  37 ,  38  used as the conveyance means in the handling portion and depicted in FIGS. 7 a  and  7   b ).  
         [0037]    As illustrated in FIGS. 6 a  and  6   b,  manifold  30  is connected to tubes  54 ,  55 ,  56 , and  57  with any suitable connection means known in the art. Any suitable connection which allows such a transfer can be employed in the present invention. One suitable connection means are indexing ports  31 ,  32 ,  33 , and  53  as illustrated in FIG. 6 a  that are respectively associated with tubes  54 ,  55 ,  56 , and  57 , and serve as an “end” to the tubes and allow the materials to pass through manifold  30 .  
         [0038]    Like the tubes in the handling portion, the tubes in the catheter portion aid device  100  in carrying out the specified functions. For example, as depicted in FIG. 2, tube  55  is associated with a video port  17  in catheter shaft  8 . Tube  56  is associated with a light injection port  15  in catheter shaft  8 . Tube  54  is associated with balloon injection port  13  in catheter shaft  8 . Tube  57  is associated with injection/instrument port  16  in catheter shaft  8 .  
         [0039]    Catheter shaft  8  is connected to proximal collar  7  using any suitable means known in the art that will allow these two components to remain in a fixed orientation or alignment. By fixing the alignment between these two components, two holes  27  can be placed a proximal collar  7  that will allow first deflection wire  24  and second deflection wire  25  to exit from proximal collar and be connected to attachment rod  40  in body  45  when the handling portion is connected to the catheter portion.  
         [0040]    As depicted in FIG. 3, catheter shaft  8  extends about a central axis to distal end  11 . Shaft  8  may be formed from a material-such as a semi-soft polymer like a polyester elastomer—which provides good columnar strength and collapse resistivity while allowing some flexibility. The end  11  of a catheter shaft  8  is a soft clear tip made of any suitable material. Suitable materials include those which will not damage or otherwise adversely impact sensitive and delicate internal structures. Suitable materials include any of the medical grade materials described above. The catheter shaft  8  can be made to fit any desired length or diameter. Optionally, the tip of catheter shaft can be tapered (as known in the art) to facilitate penetration of tissues during insertion into the body cavity.  
         [0041]    As illustrated in FIG. 4, first deflection wire  24  and second deflection wire  25  run the length of flexible catheter shaft  8  through ports  14  and  18 . These deflection wires are anchored in the soft tip of catheter shaft  8  at positions  22  and  23 . These deflection wires can be made of any suitable material, such as stainless steel, and configured so they are strong, yet flexible. When these wires are contracted, they “pull” flexible shaft into positions  10   a  and  10   b,  as shown in FIG. 1, because they are anchored to the tip. The tip can be “pulled” by any either wire at an angle (relative to the axis of shaft  8 ) ranging from 0 degrees to about 180 degrees. Thus, the tip can encompass a full 360 degree range of motion.  
         [0042]    Catheter shaft  8  also contains balloon injection port  13 , as illustrated in FIG. 3. This port runs the length of the shaft and terminates at the flexible balloon  21  near the end of catheter shaft  8 . This port also encloses and contains tube  54 . As fluid  9  is pumped from the handling portion, it enters through port  13  and travels the length of tube  54  and enters flexible balloon  21 . Balloon  21  inflates as additional amounts of fluid  9  are pumped into it.  
         [0043]    Balloon  21  is attached to catheter shaft  8  at the ends of the balloon at locations  103  and  104 . Thus, when fluid  9  enters the cavity created by balloon, the ends remain attached to the shaft while the middle inflates. The ends of balloon  21  can be attached to the catheter shaft by any suitable mechanisms or method known in the art, such as by thread winding and a bonding agent. In one aspect of the invention, the ends of the balloon are attached by RF welding. Balloon  21  can be made of any suitable material known in the art, such a s compliant material like latex or silicone rubber.  
         [0044]    Balloon  21  is preferably a low pressure, high-volume balloon. The inflated outer diameter of the balloon is dependent upon the space in which the balloon is inflated. Once the balloon reaches a maximum radial dilation, it expands longitudinally within the epidural space. In this manner, the expansion of the balloon is adequate to rupture the fibrosis of the epidural lesion while preventing damage within the nerves within the cavity such as the epidural space or damage to the dura mater and the spinal column itself. The maximum pressure at which the balloon may be inflated is about 250 mm Hg. Balloon inflation time preferably should not exceed 10 seconds, while balloon deflation time should not exceed 30 seconds. The volume of balloon  21  when inflated is preferably less than 1 cc.  
         [0045]    Tubes  56 ,  57 , and  55  run the length of catheter shaft respectively through ports  15 ,  16 , and  17 . Ports  15 ,  16 , and  17  are open at their respective ends. The light  19  (for illuminating) enters through tube  56 , travels along port  15 , and then exits into the body cavity. The light  20  (for viewing) is then reflected from the body cavity, travels along port  17 , and back through tube  55 . Instruments or other fluid injections are inserted through tube  57 , along port  16 , and exit into the body cavity.  
         [0046]    Device  100  operates in the following manner. The device is steered by using triggers  5 . The force applied to a trigger by a user will pull the desired attachment rod which will, in turn, pull on the appropriate wire. The action of pulling the wire will cause the distal end  11  of the catheter shaft  8  to deviate from the distal end at the desired angle from the shaft axis. Releasing the trigger will then return the distal end  11  to its position along the shaft axis.  
         [0047]    In one aspect of the invention, additional wires (with the accompanying elements such as ports in the manifolds, triggers, etc . . . ) can be added for additional directions and dimensions of tip deviation. In another aspect of the invention, the mechanical means for tip deviation (the wires and associated elements) can be replaced with non-mechanical (i.e., magnetic or electromagnetic) means for tip deviation.  
         [0048]    A user can view the body cavity using device  100  in the following manner. Although device  100  is described using fiberoptics, any fluoroscopic means could be employed. A light source is attached to port  1  to send light along tube  37 . The light passes through manifold  51  via port  43 , through manifold  30  via port  33 , into tube  56  along port  15 , and then exits into the body cavity. The light  20  (for viewing) is then reflected from the body cavity, travels along port  17 , and back through tube  55 , through manifold  30  via port  32 , through manifold  51  via port  42 , through tube  36 , and through video connection port  2  where the image is displayed in any desired display medium.  
         [0049]    A user inflates the inflatable means (balloon) of device  100  in the following manner. Actuating trigger  12  will cause pump  34  to pump fluid  9  from the reservoir and inject the fluid along tube  35 , through manifold  51  via port  41 , through manifold  30  via port  31 , through tube  54  in port  13 , and into balloon  21 . The more fluid  9  that is injected, the more the balloon is inflated. Once the balloon is inflated to the desired level, the trigger  12  is slowly released. The negative pressure caused by the release will cause fluid  9  to reverse direction along this path and return to the reservoir.  
         [0050]    Instruments or other injections are inserted through port  3 , along tube  38 , through manifold  51  via port  50  through manifold  30  via port  53 , through tube  57  in port  16 , and into the body cavity. These instruments can be used for various surgical procedures as known in the art. Other liquids, such as steroic liquids for treatment or radioactive liquids for fluoroscopic analysis, can also be injected in a similar manner.  
         [0051]    Generally, by using device  100  a user can control and manipulate the catheter  46  while simultaneously viewing the body cavity under inspection. Further, a user can positionally locate, isolate, and view problem, as well as visually record and visually document the problem area. Since catheter  46  is flexible and maneuverable within the epidural space, the method also provides less radical interspinal surgical operations because problem areas can more effectively be observed and accessed with the optical and steerable combined functions. The device of the present invention can be used for any type of surgery known in the art, including laser, ultrasound, and electrocautery surgeries.  
         [0052]    Specifically, the devices of the present invention are used to treat afflictions within any cavity of the body. In one aspect of the invention, the devices of the present invention are employed in methods for treating fibrotic lesions in the epidural space of the spinal column. One such method involves inserting a device of the present invention into the epidural space using the steerable and fiberoptic functions of the device. Once located in the epidural space, the fiberoptic and steerable mechanisms of the device are used to quickly and efficiently explore and analyze the epidural space. Once an affliction is located in the epidural space—such as a fibrotic lesion, adhesion, or scar tissue—the inflatable mechanism is used to dilate the epidural space, decompress adhesions, and remove scar tissue. When a balloon is used as the inflatable mechanism, the balloon is positioned across the fibrotic lesion, and the balloon is inflated radially and/or longitudinally to sever or disrupt the fibrosis comprising the epidural lesion.  
         [0053]    To perform a treatment, as known in the art, a needle is first used to access the sacral foramen. The ligamentum-flavum,  24  is then pierced and the needle tip is inserted in the sacral hiatus or other spinal levels. A guide wire is inserted and advanced through the needle and into the epidural space. The needle is extracted from the epidural space  110  and discarded. A dialating or introducer sheath can then be placed over the guide wire.  
         [0054]    The catheter  46  is then inserted through the introducer sheath over the guide wire and into the opening to the epidural space  110 . The guide wire functions to guide catheter  46  into the sacral hiatus. Because the catheter  46  is a steerable catheter, the body  45  and flexible distal end  11  ease the advancement and positioning of the catheter within and around the epidural space. If desired, the position of the steerable catheter within the epidural space may also be fluoroscopically observed as known in the art. Once in the epidural space, device  100  is advanced into the distended portion of the epidural space. The optical function of device  100  illuminates the distended portion of the epidural space to thereby visualize and display the epidural space and a problem area therein. The problem area is then analyzed. The catheter can be manipulated to place the distal end  11  into an optimal position, e.g., one where balloon  21  could be inflated but without hindering positioning of instruments or devices used in surgical procedures.  
         [0055]    Then, the requisite treatment is performed using the balloon or other instruments/injections to disrupt a fibrotic lesion, performing a diskectomy, or other types of procedures. In one aspect of the invention, fluid  9  is used to inflate balloon  21 . As balloon  21  inflates, it expands radially outwardly, concentrically about shaft  8 , rupturing and dislodging the fibrosis as it expands. As inflation of the balloon  21  continues, the outer diameter of the balloon expands toward the walls of the epidural space compressing the fibrosis therebetween, exerting a force against the walls of the epidural space. As inflation continues further, the pressurized fluid in the balloon  21  interior finds the path of least resistance, causing the balloon to expand longitudinally within the epidural space and parallel to the axis of shaft  8 . As balloon  21  expands longitudinally, the force against the walls of the epidural space is maintained. In this manner, the longitudinal expansion of balloon  21  further increases the surface area of the balloon which contacts, ruptures and compresses the fibrosis of the lesion. As known in the art, the size and shape of the epidural space will affect the extent of radial and longitudinal expansion of balloon  21 . After balloon  21  has been inflated and the fibrosis treated, negative pressure is applied to the interior of the balloon as described above, causing deflation of the balloon. The catheter  46  then may be repositioned to treat an adjacent portion of the same lesion or to treat another lesion at a different site. After the dilatation(s) and any other desired medical procedures have been completed, the catheter is withdrawn from the epidural space.  
         [0056]    The method of the present invention thereby provides improved visualization of the epidural space and more effective treatment of problems areas therein. The method allows the user to effectively observe and document the problem area and then determine the most effective treatment for the patient. Since the steerable catheter is preferably quite flexible and maneuverable within the epidural space, the method also provides less radical interspinal surgical operations because problem areas can more effectively be observed and accessed with the optical and steerable combination.  
         [0057]    Having described the preferred embodiments of the present invention, it is understood that the invention defined by the appended claims is not to be limited by the particular details set forth in the above description, as many apparent variations thereof are possible without departing from the spirit or scope thereof.