US 6,470,209 B2Grant
System for enhancing visibility in the epidural space
Issue Date:2002-10-22
•35 Claims
•8 Drawing Sheets
Abstract
A method of epidural surgery is provided that improves visibility in the epidural space of a patient for more effectively conducting therapeutic surgery therein. The method includes the steps of distending a portion of the epidural space of a patient by filling the portion of the epidural space with a fluid supplied from a catheter and positioning a portion of an optical scope in the distended portion of the epidural space by inserting the optical scope through the same catheter that supplies the distending fluid to thereby provide a visual image of the epidural space.
Metadata
Assignee
- Catheter Imaging Systems, Inc.
Inventor
- Phillip Jack Snoke
Application Information
Application Number:US 09/351,388
Filing Date:1999-07-13
Priority Date:1992-07-06
Art Unit:7
Classifications
IPC:
A61B 600
Field of Search:
604 9501604 9504604523600101600139600141600144600153600156600160600476600478
Patent Drawings (8 sheets)
Description
Related Applications
[0002] This application is a continuation of U.S. Ser. No. 09/066,884, filed Apr. 27, 1998, now U.S. Pat. No. 6,010,493, which is a continuation of U.S. Ser. No. 08/957,998, filed Oct. 22, 1997, now U.S. Pat. No. 5,857,996, which is a continuation of U.S. Ser. No. 08/606,084 filed Feb. 23, 1996, now abandoned, which is a continuation of U.S. Ser. No. 08/321,174 filed Oct. 11, 1994, now U.S. Pat. No. 5,496,269, which is a continuation of U.S. Ser. No. 08/129,331, filed Sep. 30, 1993, now U.S. Pat. No. 5,354,266, which is a continuation-in-part of U.S. Ser. No. 07/908,403, filed Jul. 6, 1992, now U.S. Pat. No. 5,342,299, and a continuation-in-part of U.S. Ser. No. 07/963,431 filed Oct. 19, 1992, now U.S. Pat. No. 5,423,311, so a continuation-in-part of U.S. Ser. No. 07/970,490 filed Nov. 2, 1992, now U.S. Pat. No. 5,399,164.
Field of the Invention
[0003] This invention relates to surgical methods, and more particularly to methods of epidural surgery in and around the epidural space.
Background of the Invention
[0004] Back pain, and particularly lower back pain, is a major expense to society and is one of the most common disabling problems of those of working age. Injuries to the back vary from herniated disks of the spine to muscle strains and nerve damage. In the back or posterior end of the human body, the epidural space is potential space located in and extending the length of the spine. The epidural space is defined along one edge or side by the dura mater which surrounds the spinal cord. The epidural space is further defined along a second edge or side by the periosteum of the bony vertebrae or by the ligamentum-flavum at the vertebral interspaces. Along the interior surface of the ligamentum-flavum lies the venus plexus, a complex configuration of veins. The epidural space contains fat, connective tissue, blood vessels, lymphatic vessels, nerve fibers, and other structures. Various lesions, cystical masses, and nerve damage can occur in and around the epidural space which causes various back problems for the human body.
[0005] Although applying anesthesia to the epidural space has been known for procedures such as child birth or the like, the anatomy of the epidural space and related structures has not been fully investigated. Conventionally, the insertion of a catheter, fluid introducer, or the like for inducing spinal anesthesia directly into the subarachnoid space of the spinal column, such as seen in U.S. Pat. No. 5,232,442 by Johnson, et al. entitled “Method And Apparatus For Inducing Anesthesia”, has been through fluoroscopic or radiographic observation. Fluoroscopic observation techniques have also been used to try to locate the various sources of problems associated with back pain such as seen in U.S. Pat. No. 5,215,105 by Kizelshteyn, et al. entitled “Method Of Treating Epidural Lesions”. The fluoroscopic techniques are helpful for general guidance of instruments or other devices, but fail to give the physician or other medical personnel a detailed picture of structures within vessels or cavities, such as the epidural space, and therefore are limited in identifying the source of back pain problems.
[0006] Also, endoscopes have been used whereby internal areas or organs within a body vessel or cavity may be observed by inserting an elongated insertable part of the endoscope through a tube or sleeve inserted into a body vessel or cavity, or directly into the body vessel or cavity itself, such as seen in U.S. Pat. No. 5,195,541 by Obenchain entitled “Method Of Performing Laparoscopic Lumbar Discectomy”. An endoscope, as used herein, is an instrument for examining the interior of a bodily canal or hollow organ. A catheter, on the other hand, is a tube inserted into a bodily channel, such as a vein, to maintain an opening to a body vessel or cavity. These endoscopes, however, are relatively large with respect to a catheter and, therefore, do not cooperate with a catheter for performing delicate surgery such as the type surrounding the back or spinal column.
[0007] Further, fiber optic scopes or fiberscopes have been used for various types of surgery such as surrounding the heart. 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. Because the epidural space collapses around an instrument or device inserted therein such as a catheter, an endoscope, a fiberscope, or a cutting tool, the space has not been considered for optical scope viewing or for performing many types of epidural surgical procedures.
[0008] Therefore, there is still a need for a method of epidural surgery that allows a physician to effectively enter the epidural space of a patient, visually observe and document a problem area which could be the source of back pain in the patient, and therapeutically treat the problem area in or around the epidural space in a minimal amount of time and with minimal amount of cutting and other potential damage to the patient during surgery.
Summary of the Invention
[0009] The present invention provides a method of epidural surgery that improves visibility in the epidural space of a patient for more effectively conducting therapeutic surgery therein. The method of epidural surgery involves distending a portion of the epidural space by filling the portion of the epidural space with a fluid supplied from a catheter positioned in the epidural space and positioning a portion of an optical scope in the distended portion of the epidural space by inserting the optical scope through the catheter to thereby provide a visual image of the epidural space. The method of epidural surgery also allows a physician, or other medical personnel, to control and manipulate the catheter and an imaging source while simultaneously using surgical tools, such as fiberoptic scopes or the like, and fluids needed for medical operations to thereby allow the physician to positionally locate, isolate, and view problem areas within the epidural space. Because the method of epidural surgery minimizes cutting and other potential damage to the patient during surgery, the invention provides a method of epidural surgery that often can be performed as an outpatient procedure.
Brief Description of the Drawings
[0010] Some of the objects and advantages of the present invention having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings, in which:
[0011] FIG. 1 is a fragmentary skeletal view of a human body illustrating spinal column regions thereof;
[0012] FIG. 2 is a fragmentary view of a spinal column illustrating the position of the epidural space therein;
[0013] FIG. 3 is an elevational plan view of a surgical operation on a patient having a catheter positioned through an opening in the sacrum region and into the epidural space by a physician for therapeutic treatment of a problem area according to a first embodiment of the present invention;
[0014] FIG. 4 is perspective view of an imaging apparatus for the methods according to the present invention;
[0015] FIG. 5 is a side elevational view of a catheter having a fiberscope inserted therein for the methods according to the present invention;
[0016] FIG. 6 is a perspective view of a catheter having a fiberscope inserted therein for the methods according to the present invention;
[0017] FIG. 7 is fragmentary top elevational view of a catheter for the methods according to the present invent:ion;
[0018] FIG. 8 is an enlarged cross-sectional view of a first embodiment of a catheter taken along line 8—8 of FIG. 7 for the methods according to the present invention;
[0019] FIG. 9 is an enlarged cross-sectional. view of a second embodiment of a catheter taken along line 8—8 of FIG. 7 for the methods according to the present invention;
[0020] FIG. 10 is an enlarged distal end plan view of a catheter taken from a distal end thereof for the methods according to the present invention;
[0021] FIG. 11 is enlarged fragmentary top plan view of a distal end of a catheter and having phantom lines therein illustrating the positioning of the multiple lumens within the catheter for the methods according to the present invention;
[0022] FIG. 12 is enlarged fragmentary side plan view of a distal end of a catheter for the methods according to the present invention;
[0023] FIG. 13 is a block diagram of a method of epidural surgery according to a first embodiment of the present invention; and
[0024] FIG. 14 is a block diagram of a method of epidural surgery according to a second embodiment of the present invention.
Description of Illustrated Embodiments
[0025] The present invention now will be described more fully hereinafter with reference to the accompanying drawings in which a preferred embodiment of the invention is shown. Like numbers refer to like elements throughout.
[0026] In the back region or posterior end of the human body, as best illustrated in FIGS. 1 and 2, the epidural space 20 is potential space located in and extending the length of the spine 18. As illustrated in the fragmentary view of a spinal region 18 in FIG. 2, the epidural space 20 has a generally cylindrical or crescent type shape and is defined along one edge or side by the dura mater 22 which surrounds the spinal cord 19. The epidural space is further defined along a second edge or side by the periosteum of the bony vertebrae 23 or by the ligamentum-flavum 24 at the vertebral interspaces 25. Along the interior surface of the ligamentum-flavum 24 lies the venus plexus 26, a complex configuration of veins. The epidural space 20 is a collapsible potential space that contains fat, connective tissue, blood vessels, lymphatic vessels, nerve fibers, and other structures. Various lesions, cystical masses, and nerve damage can occur in and around the epidural space which causes various back problems for the human body. For example, fibrosis ranging from soft to tougher scar tissue may form randomly or in layers and adhere to the dura mater 22 and the periosteum of the body vertebrae 20 or the. ligamentum-flavum 24 which form lesions extending across the epidural space 20. These lesions can be caused by post operative scarring of nerves such as from laminectomy procedures. A ruptured, leaking, or torn disk can also cause lesions which are often the source of back pain.
[0027] The method of epidural surgery according to the present invention improves visibility in the epidural space 20, of a patient for more effectively conducting therapeutic surgery in and around the epidural space 20 such as applying a steroic fluid, performing a diskectomy, or disrupting a fibrotic lesion. The method of epidural surgery according to the present invention involves distending a portion of the epidural space 20 by filling the portion of the epidural space 20 with a fluid, preferably a liquid such as a normal saline solution, supplied from a catheter 30 positioned in the epidural space 20. As best shown in FIGS. 3-6, a portion of an optical scope 60 is positioned in the distended portion of the epidural space 20 by inserting the optical scope 60 through the catheter 30 to thereby provide a visual image 100 of the epidural space 20.
[0028] According to first and second embodiments of the present invention, the catheter 30 may be one of the numerous types of catheters known to those skilled in the art, but preferably is a multi-lumen, steerable catheter 30 as best illustrated with reference to FIGS. 5-12. The multi-lumen, steerable catheter 30 preferably has a multiple durometer tube portion 40 extending outwardly from a handle portion 35 such as disclosed and described in copending U.S. patent applications Ser. No. 07/908,403 filed on Jul. 6, 1992 and Ser. No. 07/970,490 filed on Nov. 2, 1992 which are hereby incorporated herein by reference. The optical scope 60 is preferably an 0.88 millimeter (mm) fiberscope, known to those skilled in the art, that may be inserted through a lumen 42 of the steerable catheter 30, and preferably through a fiberoptic sheath 6 as shown in FIG. 5 and have a portion 62 thereof extend into the epidural space 20. The fiberscope 60 preferably communicates with an imaging apparatus such as disclosed and described in copending U.S. patent application Ser. No. 07/963,431 filed on Oct. 12, 1992 which is also hereby incorporated herein by reference. As such, further details of the steerable catheter 30, the optical scope 60, and the imaging apparatus 80 will not be discussed except in relation to the operation thereof for the methods of epidural surgery according to the present invention.
[0029] By providing the combination of the steerable catheter 30, the fiberscope 60, and the imaging apparatus 80, as illustrated in the elevational plan view of FIG. 3, a physician 17, or other medical personnel, can control and manipulate the catheter 30 and the imaging source 82 of the imaging apparatus 80 while simultaneously using surgical tools, such as cutting instruments or the like, and fluids needed for medical operations to thereby allow the physician to positionally locate, isolate, and view problem areas on a television monitor 84, i.e., cathode ray tube display device, within the epidural space 20. The imaging apparatus 80 enables the physician to not only observe the visual image 100 of the distended portion of the epidural space 20, but also provides a means for recording and documenting the problem area such as the video cassette recording 86 mounted below the imaging source 82 and television monitor 84 on the portable stand 88. Since the steerable catheter 30 is preferably quite flexible and maneuverable within the epidural space 20, as best shown in FIGS. 6 and 7, the method also provides less radical interspinal surgical operations because problem areas can more effectively be observed and accessed with the optical scope 60 and steerable catheter 30 combination. Because the imaging apparatus 80 is mounted on a stand 88 having wheels 87, as best shown in FIG. 5, the physician 17, and other medical personnel, can position the apparatus 80 close to the operation site. The control panel 83 and imaging source 82 of the imaging apparatus 80 provides image 100 adjustments, focus, and magnification to assist in viewing the epidural space 20 and the problem area when the portion of the epidural space 20 is distended by the liquid. It will be understood that the distended portion of the epidural space 20 to be viewed is preferably an amount of the epidural space 20 less than the entire boundaries thereof, the boundaries or peripheries being previously defined and described with reference to FIG. 3.
[0030] More particularly with reference to the block diagrams illustrated in FIGS. 13 and 14, and the elevational plan view of a surgical operation in FIG. 3, the method of epidural surgery according to the present invention includes inserting a needle through the skin of a patient 120, preferably through a sacrum region 125 (FIG. 13) or a lumbar region 135 (FIG. 14) of the patient 120, and into the epidural space 20 to thereby provide an opening from the skin into the epidural space 20 of the patient 120.
[0031] As illustrated in FIG. 1, the sacrum region 125 is at a lower end of the spinal column 18 below L-5 and adjacent the pelvic region 28. The sacrum 125 is a triangular shape bone formed generally by five fused vertebrae, i.e., sacral vertebrae, that are wedged dorsally between the two hip bones of the pelvic region 28 in this region of the human anatomy. It will also be understood by those skilled in the art that the invention is also applicable to various animals for veterinarian epidural procedures. The lumbar region 135 extends from L-1 to L-5 between the sacrum region 125 at a lower end and the thorax region (T-1 to T-12) at an upper end. The thorax region (T-1 to T-12) from an upper part 150 (T-12) lumbar region 135 to neck.
[0032] As illustrated in FIG. 13, according to a first embodiment of a method of epidural surgery 160 according to the present invention, the patient is scrubbed in the sacrum region 125, preferably in an area around the sacral canal and up to the level of T-8 (FIG. 1) with wide prep iodine, as shown by block 161. The patient 120 is draped, the physician 17 is scrubbed, and dressed in a sterile gown (FIG. 3). The entry site is prepared and a one percent (1%) Xylocaine solution is injected to create a skin wheel. The patient 120 is then sedated with Versed which is individually titrated to the patient's needs. The patient is also monitored with pulse oximetry, EKG, and a blood pressure monitor 42.
[0033] After the patient is scrubbed and prepared, a needle, preferably an 18-gauge Touhy needle, is used to access the sacral foramen, as shown by block 162. The ligamentum-flavum 24 (FIG. 2) is pierced and the needle tip is inserted in the sacral hiatus. Under fluoroscopic guidance, as shown by block 163, a guide wire, preferably a 0.035-inch straight tip floppy guide wire, is inserted and advanced through the needle and into the epidural space. The guide wire is preferably radiopaque and formed of stainless steel with a Teflon coating. The physician 17 then preferably fluoroscopically observes the position of the guide wire in the epidural space 20 and advances the guide wire to a spinal level where a suspected problem area within the epidural space 20 may have originated. As shown by block 164, the needle is extracted from the epidural space 20 and preferably discarded.
[0034] The catheter 30, and preferably a multi-lumen, steerable catheter, is then inserted over the. guide wire and into the opening to the epidural space 20, as shown by block 165. The guide wire functions as a guidance device as the catheter 30 is advanced into the sacral hiatus. Because the catheter 30 is preferably a steerable catheter, the handle 35 and flexible distal end 45 ease the advancement and positioning of the catheter 30 within and around the epidural space 20. Fluid is supplied, and preferably continuously supplied, to a lumen 42 of the steerable catheter 30 to thereby distend a portion of the epidural space 20. The fluid is preferably a liquid such as a normal saline solution. A normal saline bag can be accessed with an I.V. set and coupled to a three-way stop-cock, or valve for fluid regulation. A 20 cubic centimeter (cc) syringe is then coupled to a second port of the three-way stop-cock. An access port to a lumen 42 of the catheter 30 is also preferably coupled to a third port of the stop-cock. The fluid may also enter through tube portion 38 at a proximal end 37 at the handle portion 35 of the catheter 30 (as best shown in FIG. 6). The 20 cc syringe is used first to extract all the air bubbles from the I.V. set and, then fill the I.V. set with a normal-saline, liquid solution for distention of the epidural space. Twenty cc's of saline can be infused into the epidural space 20, as shown by block 166. The 20 cc's are sufficient to increase the pressure in a portion of the epidural space 20 and create a cavity in which the nerve root or other structures can be observed. The position of the steerable catheter 30 within the epidural space may also be fluoroscopically observed. The catheter 30, like the guide wire, is also preferably radiopaque. Under such circumstances, the physician can advance the steerable catheter 30 under the fluoroscopical observation to the suspected problem area.
[0035] As shown by block 167, an optical scope 60, preferably a fiber optic scope or fiberscope, is then inserted preferably within another lumen 41 of the multi-lumen, steerable catheter 30. The fiberscope 60 can enter an access port in the handle portion 35, as best shown in FIG. 6, or enter at a proximal end 37 of the handle portion 35 as shown in FIG. 3 or 4. It will also be understood that the fiberscope 60 can be inserted prior to the advancement of the catheter 30 in the epidural space 20. A portion of the optical scope 60 is advanced within the lumen 41 of the steerable catheter 30 and into the distended portion of the epidural space 20. The optical scope 60 preferably is not radiopaque and preferably will not extend into the epidural space 20 more than about one centimeter (cm). With the fluid distending a portion of the epidural space 20, the optical scope 60 can also be positioned within the distal tip 45 of catheter 30 and still view the distended portion of the epidural space 20. The optical scope 60 illuminates the distended portion of the epidural space 20 to thereby visualize and display the epidural space 20 and a problem area therein with the imaging apparatus 80, as shown by block 168. The catheter 30 can be manipulated to place the distal end 45 into an optimal position to avoid any adhesions or naturally occurring fat globules that could hinder the flow of drugs such as a steroic fluid or that could hinder positioning of instruments or devices used in surgical procedures. As shown by block 169, the catheter 30 is manipulated until the problem area such as an inflammation is recognized by its redness, increased vascularity, or other systems. The problem area is then observed and documented. As shown by block 171, a treatment is then performed to the problem area within the epidural space such as the applying of a steroic fluid to a nerve area, disrupting a fibrotic lesion, performing a diskectomy, or other types of procedures. These therapeutic treatments preferably include positioning a distal end 45 of the steerable catheter 30 adjacent the problem area within the epidural space 20 and treating the problem area within the epidural space 20 through a lumen 41 or 42 of the steerable catheter 30.
[0036] After performing the treatment, the catheter 30 is then slowly extracted and a dressing is placed at the site of entry, as shown by blocks 172, 173. The patient is observed, preferably for about two hours, then discharged, as shown by block 174. The patient's chart is completed and a one week follow-up appointment may be made.
[0037] As illustrated in FIG. 14, according to a second embodiment 180 of a method of epidural surgery of the present invention, a lumbar region 135 of the patient 120 is scrubbed and prepped, preferably in and around the L3-L4 area (FIG. 1), as shown by block 181. In this second embodiment, in contrast to the first embodiment as illustrated in FIG. 2, the patient 120 is preferably in a sitting position to spread the L1-L5 vertebrae to make access easier. It will also be understood that other sites of entry along the spinal column 18, besides the sacrum or caudal region 125 and lumbar region 135 of the patient 120, may be performed according to the present invention.
[0038] As shown by block 182, an 18-gauge Touhy needle is inserted into the interspinal space, such as between L3 and L4, using the loss of resistance technique well known to those skilled in the art. The epidural space 20 is confirmed and a guide wire, preferably a 0.035-inch straight floppy top guide wire, is inserted and advanced through the needle to the spinal level where the suspected problem area may be located in and around the epidural space 20, as shown by blocks 185, 186. The needle is then extracted (block 185) and preferably discarded.
[0039] As shown by block 187, the catheter 30 is inserted and advanced over the guide wire to the suspected problem area. The epidural space 20 is then infused with a fluid, as previously described with reference to the first embodiment, and distended (block 187). A portion of the optical scope 60 is inserted and advanced through a lumen 41 of the catheter 30 and into the distended portion of the epidural space 20, as shown by block 188. The problem area is observed and documented, and the catheter is manipulated and positioned adjacent the problem area for more effectively performing a therapeutic procedure, such as previously described (blocks 189, 191). A therapeutic procedure is then performed, also as previously described, as shown by block 192. The catheter 30 is then slowly extracted, the entry site is dressed, and the patient is observed (blocks 193-195). A follow-up visit is then scheduled and the patient discharged.
[0040] 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 physician 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 scope and steerable catheter combination.
[0041] In the drawings and specification, there have been disclosed typical preferred embodiments of the invention and, although specific terms are employed, they are used in a generic and descriptive sense only and not for the purposes of limitation. The invention has been described in considerable detail with specific reference to various embodiments. It will be apparent, however, that various modifications and changes can be made within the spirit and scope of the invention as described in the foregoing specification and defined in the following appended claims.
Claims
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What is claimed is:
1. A system for enhancing visibility in the epidural space, the system comprising:
a steerable catheter having a handle portion, a tube portion connected to the handle portion and extending outwardly therefrom, and steering means connected to at least the handle portion for steering distal end portions of the tube portion;
said tube portion having a plurality of lumen formed therewithin, including at least a first working lumen and a second working lumen, each of said first and second working lumens having distinct, non-coincident longitudinal axes and being separated from each other by a portion of the elongate tube portion,
each of said first and second working lumens being substantially symmetrically positioned along both sides of said tube diameter,
a fiber optic scope positioned to extend through the second working lumen of the steerable catheter;
said first working lumen positioned within the steerable catheter for continuously supplying fluid under pressure to the epidural space and for distending the epidural space so that the epidural space is maintained in a distended state to enhance visibility when the fiber optic scope is positioned in the second working lumen of the steerable catheter; and
an imaging apparatus connected to the fiber optic scope to display images from the fiber optic scope when said scope is positioned in the second working lumen of the steerable catheter.
2. A system as defined in claim 1, wherein the handle portion includes a plurality of access portions formed therein, and wherein the plurality of access portion is in fluid communication with at least each of said first and second working lumens, respectively amongst said plurality of lumen.
3. A system as defined in claim 2, wherein said first working lumen includes means connected to the steerable catheter for supplying a continuous pressure to a fluid in communication with the steerable catheter to maintain fluid pressure through the catheter to the epidural space thereby ensuring a continuous flow of fluid to distend and maintain in a distended state the epidural space.
4. A system as defined in claim 1, wherein the first working lumen includes means connected to the steerable catheter for maintaining the epidural space in a distended state while avoiding contact between the tube portion of the steerable catheter and structures within the epidural space when the tube portion is positioned within the epidural space.
5. The invention as defined in claim 1, wherein the system further includes a continuous fluid supplier in operable engagement with said first working lumen to continuously supply fluid to the epidural space to thereby maintain the epidural space in a distended state to enhance visibility when the fiber optic scope is positioned in the tube portion of the steerable catheter.
6. The invention as defined in claim 1, wherein the system further includes a continuous pressure supplier in operable engagement with said first working lumen to supply a continuous pressure to a fluid in communication with the steerable catheter so as to maintain fluid pressure through the catheter to the epidural space thereby ensuring a continuous flow of fluid to distend and maintain in a distended state the epidural space.
7. A system for enhancing visibility in the epidural space, the system comprising:
a steerable catheter comprising
a handle,
a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,
each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,
each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and
a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;
an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and
an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising
a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and
an image display device connected to the flexible fiber optic scope to display images of the epidural space.
8. A system for enhancing visibility in the epidural space as defined in claim 7, wherein the epidural space distender further comprises a fluid pressure regulator connected to the fluid pressure supply to regulate the fluid pressure supplied to the epidural space at a rate sufficient to maintain the epidural space in a distended state.
9. A system as defined in claim 8, wherein the fluid pressure supply of the epidural space distender comprises a pliable container in fluid communication with the first working lumen of the tube.
10. A system as defined in claim 9, wherein the fluid pressure regulator comprises a stop-cock interposed between and in fluid communication with the fluid pressure supply and the first working lumen of the tube, the stop-cock having at least one access port adapted to be coupled with a syringe having a volumetric capacity of at least twenty cubic centimeters (20 cc).
11. A system as defined in claim 8, wherein the fluid pressure supply of the epidural space distender comprises a variable pressure fluid container having a distal end positioned to be in fluid communication with the first working lumen of the tube and a proximal end connected to the fluid pressure regulator, the fluid pressure regulator positioned to selectively change the variable fluid pressure of the container.
12. A system as defined in claim 11, wherein the epidural space distender comprises a syringe.
13. A system as defined in claim 7, wherein each of the first and second working lumen having a cross-sectional diameter, the cross-sectional diameter of each of the first and second working lumen being substantially coincident with the diameter of said tube.
14. A system as defined in claim 13, wherein the cross-sectional diameter of the first working lumen is substantially different from the cross-sectional diameter of the second working lumen.
15. A system as defined in claim 7, wherein the epidural space distender comprises a syringe.
16. A system as defined in claim 15, wherein the tube connected to the handle and extending outwardly therefrom defines a first handle and wherein the epidural space distender comprises a second tube, the second tube extending outwardly from the handle, being in fluid communication with the first tube, and having a distal end connected to and in fluid communication with the syringe.
17. A system as defined in claim 7, wherein the handle portion comprises a top portion, at least one side portion extending therefrom in a direction substantially perpendicular to the top portion, and a bottom portion connected to the at least one side portion, the handle further having a medial lateral extent, a distal end lateral extent, and a proximal end lateral extent, and wherein the medial lateral extent is less than both the distal end lateral extent and the proximal end lateral extent to thereby provide the handle a substantially hour-glass configuration readily held in the hand of a user.
18. A system for enhancing visibility in the epidural space, the system comprising:
a steerable catheter comprising:
a handle,
first and second tubes each connected to the handle and extending outwardly therefrom, the first tube having a tube diameter, a flexible distal portion and at least two lumen defining first and second working lumen extending substantially parallel to each other lengthwise therein, and the second tube having at least one working lumen positioned to be in fluid communication with at least one of the working lumen of the first tube,
each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,
each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and
a controller connected to the handle to control flexible movement of the flexible distal portion of the first tube;
an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and
an epidural space imager associated with the steerable catheter to provide visual images of the epidural space, the imager comprising:
a flexible fiber optic scope positioned to extend through the second working lumen of the first tube, the first tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and
an image display device connected tot he flexible fiber optic scope to display images of the epidural space.
19. A system as defined in claim 18, wherein the handle has an upper portion, a side portion connected to the upper portion, and a lower portion connected to the side portion and underlying the upper portion, wherein the controller is at least partially contained within the handle and includes at least one lobe extending outwardly from the side portion of the handle such that the at least one lobe is readily accessible to a user holding the handle to thereby assist the user in controlling the flexing of the flexible distal portion of the first tube by the user moving the at least one lobe.
20. A system as defined in claim 19, wherein the controller comprises a control wheel having a peripheral portion, the at least one lobe connected to and extending outwardly from the peripheral portion of the control wheel.
21. A system for enhancing visibility in the epidural space, the system comprising;
a steerable catheter comprising
a handle,
a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,
each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,
each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and
a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;
an indicator associated with the handle and responsive to the controlled flexing of the flexible distal portion of the tube to thereby indicate the angular attitude of the flexible distal portion of the tube;
an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and
an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising;
a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and
an image display device connected to the flexible fiber optic scope to display images of the epidural space.
22. A system as defined in claim 20, wherein the at least one lobe extends through the side portion of the handle.
23. A system as defined in claim 19, wherein the system further includes an indicator associated with the upper portion of the handle and responsive to the controlled flexing of the flexible distal portion of the first tube to thereby indicate the angular attitude of the flexible distal portion of the first tube.
24. A system as defined in claim 23, wherein the indicator is connected to the controller and positioned on the upper portion of the handle.
25. A system as defined in claim 19, wherein the at least one lobe extends through the side portion of the handle.
26. A system as defined in claim 18, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the first tube.
27. A system for enhancing visibility in the epidural space, the system comprising:
a steerable catheter comprising
a handle having an upper portion, a side portion connected to the upper portion, and a lower portion connected to the side portion and underlying the upper portion,
a tube connected to the handle and extending outwardly therefrom, the tube having a tube diameter, a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,
each of said first and second working lumen hating distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,
each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and
a controller at least partially contained within the handle, the controller including at least one lobe connected to and extending from the side portion of the handle such that the at least one lobe is readily accessible to user holding the handle to thereby assist the user in controlling the flexing of the flexible distal portion of the first tube by the user moving the at least one lobe;
an epidural space distender comprising a fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and
an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising
a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and
an image display device connected to the flexible fiber optic scope to display images of the epidural space.
28. A system as defined in claim 27, wherein the system further includes an indicator associated with the handle, the indicator responsive to the controlled flexing of the flexible distal portion of the tube to thereby indicate the angular attitude of the flexible distal portion of the tube.
29. A system as defined in claim 28, wherein the indicator is connected to the controller and positioned on the upper portion of the handle.
30. A system as defined in claim 27, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the tube.
31. A system as defined in claim 21, wherein the handle includes a top outer surface portion, wherein the indicator comprises a tip direction indicator having a substantially flat outer surface substantially parallel to the top outer surface portion, and wherein the outer surface of the tip direction indicator rotates clockwise and counterclockwise in response to the controller to thereby indicate the angular attitude of the flexible distal portion of the tube.
32. A system as defined in claim 21, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the tube.
33. A system for enhancing visibility in the epidural space, the system comprising:
a steerable catheter comprising
a handle,
a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,
each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,
each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter,
each of the first and second working lumen having a cross-sectional diameter, the cross-sectional diameter of each of the first and second working lumen being substantially coincident with the tube diameter, and
a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;
an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and
an epidural space imager associated with the steerable catheter to enable viewing of the distended epidural space, the imager comprising a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope.
34. A system as defined in claim 33, wherein the cross-sectional diameter of the first working lumen is substantially different from the cross-sectional diameter of the second working lumen.
35. A system as defined in claim 33, herein the cross-sectional diameter of the first working lumen is substantially equal to the cross-sectional diameter of the second working lumen.
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- Michael Mark Sep. 6, 1999 letter to James Pastena; Exhibit No. 71.Applicant
- James Pastena Sep. 27, 1999 e-mail re; VueCath; Exhibit No. 72.Applicant
- VueCath Spinal Endoscopy System, Update Nov. 18, 1998; Exhibit No. 73.Applicant
- EBI Spine Sales forecast and Historical Data, Mar. 11, 1999; Exhibit No. 74.Applicant
- Notice of Deposition and Subpoena for Marty Wynkoop in Electro-Biology, Inc., vs. Myelotec, Inc.,Edward J. Lortie, and Adib I.Khoury; Exhibit No. 75.Applicant
- Felicita Cintron & Jorge A. O'Neill Aug. 20, 1998 Memo to Marty Wynkoop re: VueCath System Manufacturing; Exhibit No. 76.Applicant
- Marty Wynkoop Mar. 8, 1999 e-mail to Evivies with Mar. 12, 1999 handwritten note re: VueCath System Ordering; Exhibit No. 77.Applicant
- Marty Wynkoop Dec. 3, 1999 Fax to Dr. Mehran Heydarpour with FDA clearance for caudal approach; Exhibit No. 78.Applicant
- Draft VueCath Spinal Endoscopy System Launch package Jan. 2000; Exhibit No. 79.Applicant
- Jorge O'Neill Feb. 21, 2000 e-mail to Marty Wynkoop and others re: EPIMEd Feb. Order; Exhibit No. 80.Applicant
- Jorge O'Neill Feb. 23, 2000 & Feb. 25, 2000 e-mail to Marty Wynkoop & others re: EPImed order; Exhibit No. 81.Applicant
- Jul. 28, 1999 VueCath cost reports; Exhibit No. 82.Applicant
- Epimed Purchase Orders and Delivery Dates; Exhibit No. 83.Applicant
- Marty Wynkoop Dec. 18, 1998 Memo to Dave Whyte re: VueCath System Surgery Dec. 10, 1998; Exhibit No. 84.Applicant
- Charles Muller Feb. 4, 2000 e-mail to Wynkoop and others re; CRI visit Feb. 2, 2000; Exhibit No. 85.Applicant
- Marty Wynkoop fax to Randy Rizor re: prices; Exhibit No. 86.Applicant
- Marty Wynkoop Aug. 26, 1998 letter to Randy Rizor re Spinal Accessory Kits; Exhibit No. 87.Applicant
- Marty Wynkoop Nov. 19, 1998 Wynkoop memo to John Moore re: VueCath Sales Projections; Exhibit No. 88.Applicant
- Purchase Orders for VueCath; Exhibit No. 89.Applicant
- Marty Wynkoop Mar. 29, 1999 memo to Dave Whyte re: VueCath spinal Fixation Manufacturing Costs; Exhibit No. 90.Applicant
- VueCath System EBI Sales Plan; Exhibit No. 91.Applicant
- John Steen Jan. 29, 1999 letter to John Moore re: pricing for Catheter; Exhibit No. 92.Applicant
- Marty Wynkoop Jul. 25, 1997 memo to Rich Dickerson, with Rich Dickerson handwritten note to Gounaris re: Myelotec Internet Home Page; Exhibit No. 93.Applicant
- Jack Snoke Aug. 29, 1997 fax to Marty Wynkoop re: Myelotec activity, particularly in London; Exhibit No. 94.Applicant
- EBI's response to Respondent Visionary Biomedical, Inc., First Set of Requests for Admission to Petitioner Electro-Biology, Inc., in Electro-Biology, Inc., v. Visionary Biomedical Inc. f/k/a Myelotec, Inc., Edward J. Lortie, and Adib I. Khoury; Exhibit No. 94.Applicant
- Defendant's Response to Plaintiff's First Request for Production of Documents (from first Arbitration) in Myelotec, Inc., and Edward J. Lortie, Jr., v. Catheter Imaging Systems, Inc.; Exhibit No. 95.Applicant
- Catheter Imaging Systems, Inc., response to Myelotec, Inc., 1st request for Production of Documents (from the 1st Arbitration); Exhibit No. 96.Applicant
- Jun. 19, 1996 Catheter Imaging Systems, Inc., Motion to Dismiss; Exhibit No. 97.Applicant
- U.S. District Court Northern District of Georgia Atlanta Division in Electro-Biology, Inc. v. Myelotec, Inc., Edward J. Lortie, and Adib I. Khoury, Judge Richard W. Story's Order; Exhibit No. 98.Applicant
- Declaration of Thomas C. Barthel Jan. 19, 2001 in Electro-Biology, Inc., v. Visionary Biomedical, Inc., (formerly Myelotec, Inc.), Edward J. Lortie, and Adib I. Khoury; Exhibit No. 99.Applicant
- USPTO list of Thomas C. Barthel Patents; Exhibit No. 100.Applicant
- Clarus Medical Brochure, Clinical Background, SpineScope Epiduroscope, Clarus Medical, LLC, Minneapolis, MN; Exhibit No. 101.Applicant
- Gregory Mathison of Clarus Jul. 13, 1992 letter to Office of Device Evaluation, Rockville, Maryland re: Notification for Modification to K912089; Exhibit No. 104.Applicant
- Gregory Mathison of Clarus Sep. 1, 1992 letter to Office of Device Evaluation, Rockville, Maryland, re: 510(k) Notification for Modification to K912089; Addition of Model 2155 Percutaneous Epidural Spine Scope; Exhibit No. 105.Applicant
- Gregory Mathison of Clarus Nov. 10, 1992 letter with attachments to Steve Rhodes, Office of Device Evaluation, Rockville, Maryland, re: K925343 Model 2155 Clarus Epidural Spine Scope; Exhibit No. 106.Applicant
- Miles A. Finn from Clarus Jun. 18, 1993 letter to FDA, Center for Devices and Radiological Health re: K925343 model 2155 Clarus Epidural Spine Scope; Exhibit No. 107.Applicant
- Jun. 4, 1992 Special Work Order; Cholednchoscope, part No. 500319.001; Exhibit No. 108.Applicant
- Clarus Interoffice Memo Jun. 9, 1992 from Craig Riedl to Tom Barthel et al., re: Spine Scope, Wrist Scope and Large Joint Scope; Exhibit No. 109.Applicant
- Jul. 1, 1992 Memo to file from Kate Anderson re: Human Use of spine scope kit. Exhibit No. 110.Applicant
- Jul. 15, 1992 Memo from Greg Miles to Jim Whit, et al. Re: Discussion with Dr. Stephen Haines regarding spine scope; Exhibit No. 111.Applicant
- Clarus Interoffice Memo Jul. 8, 1992 from Whit McFarlin to list re: Clinical Game Plan Jul./Aug.; Exhibit No. 112.Applicant
- Clarus Medical Systems Aug. 27, 1992 memo from Craig Riedl to Miles Finn; re: Trip Report—spine fusion with Dr. Tradnsfeldt; Exhibit No. 113.Applicant
- Visionary Biomedical, Inc., Activities Calendar; Exhibit No.114.Applicant
- Clarus Medical Systems, Inc. Memo Sep. 3, 1992 from Miles to Tom Whit et al. Re: Dr. Transfeldt meeting notes; Exhibit No. 115.Applicant
- Clarus Medical Systems, Inc., Memo Oct. 26, 1992 to file re: Dr. Transfeldt first cadaver work at Abbott; Exhibit No. 116.Applicant
- Report on Spine Cadaver Work, Abbott Northwestern Hospital, Oct. 26-29, 1992, Notes by Miles Finn; Exhibit No. 117.Applicant
- Clarus Medical Systems, Inc., Interoffice Memo Oct. 1, 1992 from Craig Riedl to Miles Finn re: Spine Study Inventory; Exhibit No. 118.Applicant
- Clarus Medical Systems, Inc., Sep. 16, 1992 letter to Dr. Rune Blomberg, Center Hospital, Norrkoping, Sweden; Exhibit No. 119.Applicant
- Nov. 27, 1992 Telefax from Rune Blomberg to Miles Finn (Clarus Medical Systems); Exhibit No. 120.Applicant
- Blomberg Videotape; Exhibit No. 121.Applicant
- Sep. 7, 1992 Clarus Trip Report from R. Shockey; Exhibit No. 122.Applicant
- Arbitration Demand Letter Jun. 5, 1996 to Catheter Imaging Systems, Inc.; Exhibit No. 123.Applicant
- Jul. 12, 1996 Arbitrator Johnson's letter ruling re: Motion to Dismiss in Myelotec, Inc. v Catheter Imaging Systems, Inc.; Exhibit No. 124.Applicant
- Dec. 9, 1996 Johnson letter decision in Myelotec, Inc. v. Catheter Imaging Systems,Inc., Exhibit No. 125.Applicant
- Order and Final Judgement in Catheter Imaging Systems, Inc. v. Myelotec, Inc. and Edward J. Lortie, Jr., dated Feb. 4, 1997; Exhibit No. 126.Applicant
- EBI's responses to Visionary's claim preclusion summary judgement dated Aug. 21, 2000; Exhibit No. 127.Applicant
- Declaration of Edwin Bon in Electro-Biology, Inc. v. Myelotec, Inc., Edward J. Lortie, and Adib I. Khoury, dated Jul. 18, 2000; Exhibit No. 128.Applicant
- EBI Interoffice memo Apr. 7, 1997 from Marty Wynkoop to Rich Dickerson re: Dr. Rizor Visit Apr. 3-4, 1997; Exhibit No. 130.Applicant
- Michael Mark Apr. 16, 1998 letter to James Pastena; Exhibit No. 131.Applicant
- May 18, 1999 E-mail from Marty Wynkoop to Rich Dickerson re: New Myleotec Fiberscope; Exhibit No. 132.Applicant
- Jan. 28, 2000 E-mail from Rich Dickerson to Charles Muller re: VueCath Catheter Marketing; Exhibit No. 133.Applicant
- May 18, 1999 E-mail from Marty Wynkoop to Marshall Perez re: New Myleotec Fiberscope; Exhibit No. 134.Applicant
- Jan. 21, 2000 E-Mail from Charles Muller to Marty Wynkoop re: similarities and differences between EBI and Myelotec; Exhibit No. 135.Applicant
- Jan. 27, 2000 E-Mail from Charles Muller to Marty Wynkoop re: Myelotec Failures; Exhibit No. 136.Applicant
- EBI Memo Nov. 21, 1997 from Marshall Perez to Rich Dickerson re: VueCath vs. Mylotec Strategy, go out and try to convert the Myelotec customers, Exhibit No. 137.Applicant
- Nov. 11, 1999 E-Mail from Rich Dickerson to Dr. Racz re: Error in Market Share; Exhibit No. 138.Applicant
- Mar. 22, 2000 E-Mail from Marshall Perez to Dr Racz re: VueCath Sales; Exhibit No. 139.Applicant
- Mar. 30, no year, Epimed Meeting minutes; Exhibit No. 140.Applicant
- Excerpt from EBI 510K submitted Mar. 24, 1997; Exhibit No. 141.Applicant
- Excerpt from EBI 510K submitted Jul. 16, 1998; Exhibit No. 142.Applicant
- Declaration of Dr. Luke M. Kitahata in Myelotec, Inc. v. Catheter Imaging Systems, Inc., dated Nov. 18, 1996; Exhibit No. 143.Applicant
- Excerpts of Videotape deposition of Lloyd Saberski in Myelotec, Inc., and Edward J. Lortie, Jr. v. Catheter Imaging Systems, Inc.; Exhibit No. 144.Applicant
- Rune G. Blomberg, et al., The Lumbar Epidural Space In Patients Examined with Epiduroscopy The International Anesthesia Research Society 1989 pp. 157-160; Exhibit No. 145.Applicant
- Rune G. Blomberg, The Lumbar Epidural Space Astra Pain Control, 1991; Exhibit No. 146.Applicant
- Rune G. Blomberg, The Dorsomedian Connective Tissue Band in the Lumbar Epidural Space of Humans International Anesthesia Research Society 1986, pp. 747-752; Exhibit No. 147.Applicant
- Rune G. Blomberg, A Method orf Epiduroscopy and Spinaloscopy, Acta Anaesthesiol Scand. 1985, pp. 113-116; Exhibit No. 148.Applicant
- Elias L. Stern, The Spinascope; A New Instrument for Visualizing the Spinal Canal and its Contents Medical Record, pp. 31-32, Jan. 1936; Exhibit No. 149.Applicant
- J. Lawrence Pool, Myeloscopy: Intraspinal Endoscopy, vol. 11 Surgery, pp. 169-179, Feb. 1942; Exhibit No. 150.Applicant
- Yoshio Ooi et al.,Myeloscopy, International Orthopaedics 1, pp. 107-111, 1997; Exhibit No. 151.Applicant
- Bjorn Holmstrom, et al., Epiduroscopic Study of Risk of Catheter Migration Following Dural Puncture By Spinal and Epidural Needles Reg. Anest. 15(1) S:86, 1999; Exhibit No. 152.Applicant
- James E. Heavner, Percutaneous Evaluation of the Epidural and Subarachnoid Space with a Fliexible Fiberscope, Regional Anesthesia 15 (Supp.);85, 1991; Exhibit No. 153.Applicant
- Shimoji, et al. Observation of Spinal Canal and Cisternae with the Newly Developed Small-Diameter Flexible Fiberscopes, Regional Anesthesia 15 (Supp.)1988; Exhibit No. 154.Applicant
- Sven Ivar Seldinger,Catheter Replacement of the Needle In Percutaneou Arteriography vol. 39 Acta Radiologica 368; Exhibit No. 155.Applicant
- Videotape—Comparing Prior Art Procedures to Procedures Used With Visionary Device; Exhibit No. 168.Applicant
- Respondent's (Visionary Biomedical, Inc(f/k/a Myelotec, Inc).,Edward J. Lortie, and Adib I. Khoury) Claim Charts Comparing Claims to Prior Art; Exhibit No. 170.Applicant
- Chart of U.S. Patent 5,342,299, “Steerable Catheter” Serial No. 07/908,403, Filed Jul. 6, 1992, Issued: Aug. 30, 1994; Exhibit No. 171.Applicant
- Photo Exhibit No. 172.Applicant
- Appointment and Schedule Calendar for Aug. 8, 1993; Snoke; Exhibit No. 173.Applicant
- Exhibits 1-4, Exhibit 1, Clarus Manufactured Model 2160 Integral Endoscope/Catheter; Exhibit 2, Visionary Biomedical Manufactured Reproduction of Angiolaz Dual Lumen Steerable Catheter; Exhibit 3, B-Braun Manufactured Dual Lumen Steerable Catheter Model 2000 1995-1999; Exhibit 4, Visionary Biomedical Manufactured Dual-Lumen Steerable Catheter Model 2000 1999-Present; Exhibit No. 175.Applicant
- American Society Of Regional Anesthesia Syllabus, 24th Annual Meeting and Workshops, “Regional Anesthesia and Pain Medicine” May 6-9, 1999, Philadelphia, Pennsylvania; Exhibit No. 175.Applicant
- Drawing—Rizor Procedure; Exhibit No. 176.Applicant
- Drawing—Procedure; Exhibit No. 177.Applicant
- Patent Database Search Results; “Catheter Imaging Systems” in all years; Exhibit No. 178.Applicant
- Diagram of 1995 Agreement; Exhibit No. 179.Applicant
- Timeline; Exhibit No. 180.Applicant
- Drawing of Catheter; Exhibit No. 183.Applicant
- Declaration of Barton W. Bracy in Electro-Biology, Inc. v. Visionary Biomedical, Inc. (formerly Byelotec, Inc.) Edward J. Lortie and Adib I. Khoury dated, Jan. 25, 2001; Exhibit No. 199.Applicant
- Myelotec, Inc., Financial Statements Jun. 30, 2000 and 1999 (With Independent Auditors' Report Thereon); Exhibit No. 201.Applicant
- Visionary BioMedical,Inc., Balance Sheet Showing Year to Date Activity as of Period Ending December 31, 2000, for all accounts, Level of Detail; Main sorted by account No., Exclude Zero Balance Accounts, Exclude closing Entry; Exhibit No. 202.Applicant
- Visionary BioMedical, Inc., Chart of revenue and Loss for 1994 and 2001; Exhibit No. 203.Applicant
- Myelotec, Inc., Key Indicator Schedule, Actuals for FY 1997-1998; Exhibit No. 204.Applicant
- Visionary BioMedical, Inc., Report of Catheter Sales, Jan. 1, 1999-Dec. 31, 2000; Exhibit No. 205.Applicant
- Name of Doctors Trained at Myelotec Supported Programs, dated Jan. 12, 2001; Exhibit No. 206.Applicant
- Declaration of Gerald L. Birchem in Electro-Biology, Inc. v. Visionary Biomedical, Inc, (f/k/a Myelotec, Inc.) Edward J. Lortie, and Adib I. Khoury, dated Jan. 26, 2001; Khoury/Lortie Exhibit No. 1.Applicant
- Declaration of Adib I. Khoury in Electro-Biology, Inc. v. Visionary Biomedical, Inc, (f/k/a Myelotec, Inc.) Edward J. Lortie, and Adib I. Khoury, dated Jan. 26, 2001; Khoury/Lortie Exhibit No. 2.Applicant
- Declaration of Edward J. Lortie in Electro-Biology, Inc. v. Visionary Biomedical, Inc, (f/k/a Myelotec, Inc.) Edward J. Lortie, and Adib I. Khoury, dated Jan. 26, 2001; Khoury/Lortie Exhibit No. 3.Applicant
- Certified Copies of Myelotec, Inc. a Domestic Profit Corporation;Certificate of Merger; Certificate of Amendment; Certificate of Restated Articles of Incorporation; Certificate of Incorporation; Khoury/Lortie Exhibit No. 4.Applicant
- Independent Auditors Report, Myelotec, Inc., Jun. 30, 1996-Jun. 30, 2000; Khoury/Lortie Exhibit No. 6.Applicant
- Aug. 22, 1990 FDA letter to Dr. Khoury re; Ultra-Vu Angioscope; Khoury/Lortie Exhibit No. 7.Applicant
- Dr. Fuad Sabra Apr. 1, 1986 letter to Dr. George Abella re: Recommendation to Dr. Khoury; Khoury/Lortie Exhibit No. 8.Applicant
- Dr.Sawaya letter (no date) to Dr. George Abella re: Recommendation of Dr Khoury; Khoury/Lortie Exhibit No. 9.Applicant
- Board Of Medical Examiners Jun. 18, 1997 letter to Dr. Khoury; Khoury/Lortie Exhibit No. 10.Applicant
- Nov. 15, 1991 Dr. Khoury Letter to Edward Lortie re: AngioLaz undergoing develepment of endoscopic systems under private Label agreement to Solos Endoscopy; Khoury/Lortie Exhibit No. 11.Applicant
- Rune G. Blomberg, MD and Sven S. Olsson, MD, “The Lumbar Epidural Space in Patients Examined With Epiduroscopy,” Anesth. Analg. 1989, 68: 157-160; Khoury/Lortie Exhibit No. 12.Applicant
- Rune G. Blomberg, MD, “The Lumbar Epidural Space”; Khoury/Lortie Exhibit No. 13.Applicant
- Rune G. Blomberg, M.D., “The Dorsomedian Connective Tissue Band In the Lumbar Epidural Space of Humans”, Anesth. Analg., 1986;65; 747-52; Khoury/Lortie Exhibit No. 14.Applicant
- Rune G. Blomberg, M.D. “A Method For Epidurascopy and Spinaloscopy”, Anesth. Analg., 1985; 29; 113-116; Khoury/Lortie Exhibit No. 15.Applicant
- Elias Lincoln Stern, “The Spinascope: A New Instrument For Visualizing The Spinal Canal And Its Contents”, New York, Medical Record, Jan.; Khoury/Lortie Exhibit No. 16.Applicant
- J. Lawerence Poor, M.D., “Myeloscopy; Intraspinal Endoscopy”, Surgery vol. 11, Feb. 1942, No. 2; Khoury/Lortie Exhibit No. 17.Applicant
- Yoshio Ooi et al., “Myeloscopy”, International Orthopaedics, pp. 1,107-1,111, 1997; Khoury/Lortie Exhibit No. 18.Applicant
- Bjorn Holmstrom, M.D. et al., Epiduroscopic Study of Risk Of Catheter Migration Following Dural Puncture By Spinal And Epidural Needles—A Video Presentation, Department of Anesthesiology, Lindesberg Hospital, Orebro, Sweden; Khoury/Lortie Exhibit No. 19.Applicant
- James E Heavner DVM et al. “Percutaneous Evaluation Of The Epidural And Subarachnoid Space With A Flexible Fiberscope”, Regional Anesthesia 1991; pp. 1551-1585; Khoury/Lortie Exhibit No. 20.Applicant
- Koki Shimoji, M.D., “Observation of Spinal Canal and Cisternae with the Newly Developed Small-Diameter, Flexible Fiberscopes”, Anesthesiology 1991; 75: pp. 341-344; Khoury/Lortie Exhibit No. 21.Applicant
- Sven Ivar Seldinger, “Catheter Replacement of the Needle In Percutaneuos Arteriography”, Beontgen Diagnostic Department, Stockholm, Sweden, 1952; Khoury/Lortie Exhibit No. 22.Applicant
- AngioLaz, “Investigational Device Exemption Application”, AngioLaz System II, May 9, 1991; Khoury/Lortie Exhibit No. 23.Applicant
- MedPRO Month, vol. 1: No. 12, Dec., 1991; Khoury/Lortie Exhibit No. 25.Applicant
- Brouchure, Dynapace Systems, Inc, Introduces The New Epidural Ultra VU Scope System, ASA Meeting—San Francisco, CA, Oct. 28-30, 1991; Khoury/Lortie Exhibit No. 26.Applicant
- Dr. Khoury May 6, 1996 letter to Dr. Randy Rizor, re: Epidural Scope; Khoury/Lortie Exhibit No. 27.Applicant
- Yale Videos; RX-36, 37, 38; Khoury/Lortie Exhibit No. 28.Applicant
- Photos of Epidural Scope; Khoury/Lortie Exhibit No. 29.Applicant
- Angiolaz Incorporated, Rockingham, VT., Drawing No. AS-509;Khoury/Lortie Exhibit No. 30.Applicant
- “Interventional Intraspinal Techniques Using A Visually Guided Epidural Catheter”, Dr. Randy Rizor et al., Case Reports; Khoury/Lortie Exhibit No. 32.Applicant
- Dr. Randy Rizor Jun. 8, 1992 letter to Dr. David Brandenburg, Institutional Review Committee re: Presenting the procedure of epiduroscopy to the Review Committee; Khoury/Lortie Exhibit No. 33.Applicant
- Edward Lortie Oct. 15, 1992 letter to Dr. Khoury re: Offer to position of Vice-President of Business Develepment; Khoury/Lortie Exhibit No. 34.Applicant
- Catheter Imaging Systems Board of Directors Meeting Notes Jul. 20, 1993; Khoury/Lortie Exhibit No. 35.Applicant
- Handwritten notes from Jul. 20, 1993 Catheter Imaging Systems Board of Directors Meeting; Khoury/Lortie Exhibit No. 36.Applicant
- Myelotec, Inc., Stock Subscription Agreement, dated Oct. 25, 1993; Khoury/Lortie Exhibit No. 38.Applicant
- Michael G. Cassaro—Southeast Seminars, Inc., May 27, 1994 letter to Dr. Khoury re; Misrepresentation in a course manual; Khoury/Lortie Exhibit No. 39.Applicant
- Settement Agreement between Catheter Imaging Systems, Inc., P. Jack Snonke, Michael J. Mark, William J. Mack, Myelotec, Inc., and Edward J. Lortie, dated May, 1995; Khoury/Lortie Exhibit No. 42.Applicant
- Dismissal With Prejudice in Catheter Imaging Systems, Inc., v. Edward J. Lortie, Michael Mark, William J. Mack and P. Jack Snoke, dated Jun. 16, 1995; Khoury/Lortie Exhibit No. 43.Applicant
- James C. Grant Nov. 21, 1995 letter to Edward J. Lortie and William R. Johnson re: Notice of Dispute; Khoury/Lortie Exhibit No. 44.Applicant
- William H. Needle May 24, 1996 letter to Catheter Imaging Systems, Snoke, Mark, Mack, James C. Grant, Esq., re: Notice of Dispute, Claim of Patent Invalidity; Khoury/Lortie Exhibit No. 45.Applicant
- Sumner Rosenberg Jun. 5, 1996 letter to James D. Johnson, Esq., Catheter Imaging Systems, Inc., P. Jack Snoke, re: Notice of Arbitration Demand, Claim of Patent Invalidity; Khoury/Lortie Exhibit No. 46.Applicant
- James C. Grant May 19, 1996 letter to James D. Johnson, Edward Lortie and Myelotec, Inc., Re: Jun. 5, 1996 Arbitration Demand; Khoury/Lortie Exhibit No. 47.Applicant
- James D. Johnson Jul. 12, 1996 letter to Sumner Rosenberg, Esq., James C. Grant, Esq., Re: Arbitration between Myelotec, Inc.(Myelotec) v. Catheter Imaging Systems, Inc.(CIS); Khoury/Lortie Exhibit No. 48.Applicant
- James D. Johnson Dec. 9, 1996 letter to Sumner Rosenberg, Esq., Jeffrey S. Whittle, Esq., Re: Myelotec, Inc. v. Catheter Imaging Systems, Inc.,Khoury/Lortie Exhibit No. 49.Applicant
- Myelotec Memo to Edward Lortie from Dr. Khoury, dated Feb. 24, 1997 Re: Dr. Khoury's resignation; Khoury/Lortie Exhibit No. 50.Applicant
- James Pastena, EBI Medical Systems, Apr. 20, 1999 letter to Edward J. Lortie, Re: issued patents; Khoury/Lortie Exhibit No. 51.Applicant
- Declaration in Support of Petition For Correction of Inventorship Under 37 C.F.R. §1.48 (a) in application of Phillip J. Snoke et al., Ser. No. 07/908,403, Filed Jul. 6, 1992, For Steerable Catheter, datedJul. 24, 1992; Khoury/Lortie Exhibit No. 52.Applicant
- Declaration in Support of Petition For Correction Of Inventorship Under 37 C.F.R. §1.48 (a) in application of Phillip J. Snoke, et al., Ser. No. 07/970,490, Filed: Nov. 2, 1992, For: Catheter Having Multiple Durometer; Khoury/Lortie Exhibit No. 53.Applicant
- Edward J. Lortie Apr. 21, 1999 letter to James Patesna, President EBI Medical Systems, Inc.; Khoury/Lortie Exhibit No. 54.Applicant
- James Pastena Apr. 30, 1999 letter to Edward Lortie Re: letter dated Apr. 21, 1999; Khoury/Lortie Exhibit No. 56.Applicant
- James Pastena May 28, 1999 letter to Edward Lortie in response to May 6, 1999 letter with executed Confidentiality Agreement; Khoury/Lortie Exhibit No. 56.Applicant
- Edward J. Lortie Jun. 3, 1999 letter to James Pastena, Re: Confidentiality Agreement; Khoury/Lortie Exhibit No. 57.Applicant
- James Pastena Jun. 25, 1999 letter to Edward J. Lortie, Re: Patent Application for: Steerable Catheter Having Segmented Tip And One-Piece, Inlet Housing, And Method Of Fabricating Same Khoury/Lortie Exhibit No. 58.Applicant
- AnioLaz Epiduroscope Apr. 6, 1992, List of examined patients and prognosis; Khoury/Lortie Exhibit No. 59.Applicant
- Catheter Imaging Systems, Inc., Jul. 9, 1993 Minutes of Meeting; Khoury/Lortie Exhibit No. 60.Applicant
- Edward J. Lortie May 11, 1994 letter to Mr. Jamie Grooms, University Of Florida—Tissue Bank, Re: G&G Marketing Plan; Khoury/Lortie Exhibit No. 61.Applicant
- Jerry Birchem Dec. 1, 1999 letter to Pete Dambach, EBI Medical Systems, Re: Financial and general information on the Myelotec Spine business; Khoury/Lortie Exhibit No. 62.Applicant
- Complaint in Electro-Biology, Inc. v. Myelotec, Inc., Edward J. Lortie and Adib I. Khoury, dated Oct. 27, 1999; Khoury/lortie Exhibit No. 63.Applicant
- Ricard D. Harris May 15, 2000 letter to James D. Johnson, Esq., Re: Electro-Biology, Inc. v. Myelotec, Inc., et al., Re: Settlement Agreement dated 5/95; Khoury/Lortie Exhibit No. 64.Applicant
- Video Tape—“Exploring Epidural Endoscopy,” Madison Avenue, RX 15 Copy.Applicant
- Video Tape—“Epidural Endoscopy/Exercise and Comments,” Yale University School of Medicine Center for Pain Management, RX 26, Copy.Applicant
- Video Tape—Angio Laz, Tapes S1, S2, S3, RX 36; MYE 14657, Duplicate Copy.Applicant
- Video Tape—Angio Laz, Tapes S4, S5,S6, RX 37; MYE 14659, Duplicate Copy.Applicant
- Video Tape—Angio Laz, Tapes S7, S8, S9, RX 38; MYE 14659, Duplicate Copy.Applicant
- Video Tape—“Discussion with Dr. Saberski,” Apr. 6, 1992; RX 25, Copy.Applicant
- Video Tape—Presentation 3/ Presentation 2; MYE 015464, Myelotec, Respondents Ex. 168. Copy.Applicant
- Video Tape—Deposition of Dr. Lloyd Saberski Nov. 7, 1996 (RT 1:44)—Edited Version, Copy.Applicant
- Petitioner Response in Electro-Biology, Inc. v. Myelotec, Inc., Edward J. Lortie and Adib I. Khoury, dated Sep. 2, 2000; Exhibit No. 92.Applicant
- Defendants reply and Certificate of Service in Electro-Biology, Inc. v. Myleotec, Inc., Edward J. Lortie, and Adib I. Khoury, Dated Aug. 23, 2000,Exhibit 90.Applicant
- Correspondence from Bradley K. Groff to James D. Johnson re: Withdrawing as Arbitrator in Electro-Biology, Inc. v Myelotect et al., Dated Aug. 18, 2000;Exhibit 87.Applicant
- Correspondence, dated May 19, 2000, from John S. Paccocha to James D. Johnson in Electro-Biology, Inc. v Myelotect, Inc., et al., with copy of “Petitioners Response to Respondents Myelotec's Motion for EBI to Designate a Limited Set of Claims On Which to Proceed,” Exhibit No. 83.Applicant
- Motion filed along with Certificate of Service in Electro-Biology, Inc. v. Myelotec, Inc., Edward J. Lortie, and Adib I. Khoury, dated May 26, 2000; Exhibit 79.Applicant
- May 22, 2000 Correspondence from Bradley K. Groff to James D. Johnson re: Arbitration: Electro-Biology, Inc. v. Myelotec, Inc., et al.;Myelotec, Inc., response; Exhibit No. 30.Applicant
- May 22, 2000 Correspondence from Bradley K. Groff to James D. Johnson re: Arbitration: Electro-Biology, Inc. v Myelotec, Inc., et al.; Response from Edward J. Lortie; Exhibit No. 29.Applicant
- May 22, 2000 Correspondence from Bradley K. Groff to James D. Johnson re: Arbitration: Electro-Biology, Inc. v. Myelotec, Inc., et al.; Response from Adib I. Khoury; Exhibit No. 28.Applicant
- May 15, 2000 Correspondence from Richard D. Harris to James D. Johnson re: Electro-Biology, Inc. v. Myelotec, Inc., et al.;re: Settlement Agreement dated May, 1995; Exhibit No. 26.Applicant
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