US20070167681A1 - Portable imaging system employing a miniature endoscope - Google Patents

Abstract

A cart or man-portable system and method for performing endoscopic procedures is provided. A portable display device, such as a laptop computer, is coupled to a handle comprising a miniature camera and fiber optic illumination subsystem. A sterile disposable portion is fitted over the illumination subsystem and inserted into a target area on a patient. Images of the target area are conveyed from the camera to the display device while an endoscopic procedure is performed, thus facilitating real-time diagnosis during the procedure.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation-in-part of co-pending International Application No. PCT/US06/008342, filed Mar. 8, 2006 which is a continuation-in-part of U.S. patent application Ser. No. 11/075,827 filed on Mar. 8, 2005 which is a continuation-in-part of U.S. patent application Ser. No. 10/042,126, filed Oct. 19, 2001. This application claims priority to an application entitled “Miniature Endoscope With Imaging Fiber System” filed Mar. 4, 2005, now U.S. application Ser. No. 11/072,685. The entire contents of the above applications are incorporated herein by reference.
BACKGROUND OF THE INVENTION
• Endoscopes enable visual examination of structure inside cavities. In the field of medicine, the use of endoscopes permits inspection of organs for the purposes of diagnosis, viewing of a surgical site, sampling tissue, or facilitating the safe manipulation of other surgical instruments.
• Laparoscopes, for example, are used particularly for examining organs in the abdominal area. Laparoscopes typically include a light pipe for illuminating the region to be viewed, at least one lens assembly for focusing and relaying the image of the illuminated object, and a housing for the entire assembly which is structured to minimize tissue damage during the surgical procedure. The light pipe can include a fiber optic element for illuminating the site. The laparoscope housing includes a distal section that can be inserted within a body cavity and a proximal section which can include a handle that a user grips to position the distal end near the surgical site.
• Existing endoscopes can include an imaging device such as a charged coupled device (CCD). This device can capture an image of an object being viewed and convey it to a display device, such as a monitor. There is a continuing need to improve on the operational features and manufacturability of endoscope systems that improve imaging capability and reduce the risk to the patient.
SUMMARY OF THE INVENTION
• The present invention relates to a small diameter imaging probe or endoscope having improved durability, resolution, and field of view. In a preferred embodiment of the invention, the distal end of the probe including a disposable sheath, can be inserted into the tissue under examination. The probe is less than 3 millimeters in diameter, and preferably less than 2 millimeters in diameter, to reduce trauma at the point of insertion and thereby provide access to sites that are otherwise unavailable for endoscopic procedures.
• In a preferred embodiment, the endoscope has a fiber optic waveguide that transmits an image from a distal end to a proximal end. A lens system is positioned at the distal end of the fiber optic waveguide. An imaging device is optically coupled to the proximal end of fiber optic waveguide. A sheath extends about the fiber optic waveguide, the sheath including illumination fibers. Although a preferred embodiment utilizes a probe and sheath assembly having an outer diameter of 2 mm or less, certain applications will accommodate a larger diameter instrument having a larger number of imaging fibers to provide a higher resolution image. These applications can utilize outer diameters in a range of 2-4 mm.
• In one embodiment, the lens system having a first lens element, a second lens element and an aperture stop. The lens system couples light from any given position on the object to a plurality of optical fibers such that the numerical aperture of light varies as a function of the angle relative to the longitudinal axis of the lens system. This provides more efficient coupling to the fiber apertures. This is accomplished using a non-telecentric lens system.
• A preferred embodiment of the lens system includes a pair of lenses and an aperture stop. The lenses are shaped to improve light collection around the periphery of the distal lens. This provides a clearer image across the entire field of view of the device. The aperture stop is positioned to provide efficient coupling to the array of fibers.
• The imaging device can be a charged coupled device (CCD), a CMOS imaging device or other solid state imaging sensor having a two dimensional array of pixel elements. The imaging sensor is mounted on a circuit board in a handle assembly. The sensor can capture an image as an object being viewed and an image processing circuit mounted onto the circuit board transfers the image data over a video cable to a computer for storage, processing and/or display.
• The miniature endoscope system can be used for orthopedic, rhematologic, general laparoscopic, gynecological or ear, nose and throat procedures small and large joints, cardiac, oncology, lung, breast, brain GI and veterinary applications for example. Although many applications require a small diameter to reduce trauma, certain applications can accommodate larger diameters. The probe can include an open channel in either the sheath or the imaging probe to provide for the insertion of other operative elements to flush the site with fluid, direct light or other energy source onto a treatment site, or to remove a tissue sample.
• The sheath assembly can include a concentric array of illumination fibers extending to a connector on a sheath hub assembly. Alternatively, the illumination fibers can couple to a fiber connector in the probe assembly that is coupled directly via fiber optic cable extending from the handle to a light source housing. The housing can include a video disk recorder that writes the video onto disk. For certain applications, an illumination bundle can be positioned within the probe such that the sheath is thinner or can accommodate a larger working channel.
• The present system, has four preferred applications for orthopedic use: in-office diagnostics, operating room surgical resections/procedures, in office post-operative evaluation, and therapeutic usage for the delivery of medications into joints, while confirming their correct location under direct visualization.
• In addition to its use in the office, the system can be used in the operating room instead of a standard arthroscope. By eliminating the need to use arthroscopic irrigation fluid or a large-bore camera, the amount of pain and swelling following an arthroscopic procedure will be substantially reduced if not eliminated. The patient can return to the office or playing field the next day.
• The system is used for the postoperative assessment of the healing process for tissue and bond graft procedures, which are not currently possible using conventional MRI techniques. Examples include: assessment of articular cartilage resurfacing procedures, meniscal repairs, labral repairs, rotator cuff repairs, fracture reductions of joint surfaces, ligament integrity, and other usages.
• The system includes a computer (or other viewing system), camera, light source and reusable handle that does not require reprocessing between procedures and a sterile barrier and lens components that is single patient use and disposable. The system eliminates the space requirements, cost of reprocessing equipment, manpower and costs associated with the time sensitive endoscope re-sterilization.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
• FIG. 1 illustrates a schematic illustration of a miniature endoscope system according to the invention;
• FIG. 2 is a cross-sectional view of cannula;
• FIG. 3 is a cross-sectional view of a trocar within a cannula;
• FIG. 4 is a perspective view of the miniature endoscope;
• FIG. 5 is a sectional view of the miniature endoscope with a cannula overlying the disposable sheath;
• FIG. 6A is a sectional view of the disposable sheath/illuminator unit;
• FIG. 6B is an enlarged sectional view of the distal end to the disposable sheath;
• FIG. 7A is a sectional view of the proximal end of the disposable sheath/illumination unit taken alongline7A-7A ofFIG. 6A;
• FIG. 7B is a front view of the distal end of the disposable sheath taken along theline7B-7B ofFIG. 6A andFIG. 6B;
• FIG. 8 is a side view of the disposable sheath/illumination unit showing the illumination pigtail;
• FIG. 9 is a sectional view of an imaging unit of the miniature endoscope;
• FIG. 10A is an enlarged view of the distal end of the imaging unit as indicated by the portion defined10A inFIG. 9;
• FIG. 10B is a front view of the distal end of the imaging unit taken along theline10B-10B ofFIG. 10A;
• FIG. 11 is a schematic of an enlarged partial sectional view of the imaging unit taken along the line11-11 ofFIG. 10A;
• FIG. 12 is an enlarged view of the distal lens system;
• FIG. 13 is a graph of the sine of the maximum ray angle versus normalized image height for different lens systems for the distal end of the endoscope;
• FIG. 14 is an enlarged view of another embodiment of a distal lens system;
• FIG. 15 is a sectional view of another embodiment of an endoscope;
• FIG. 16A is a sectional view of the endoscope taken alongline16A-16A ofFIG. 15;
• FIG. 16B is a sectional view of the endoscope taken alongline16B-16B ofFIG. 15;
• FIG. 16C is an enlarged sectional view of the imaging unit as indicated by the portion defined by10C inFIG. 16B;
• FIG. 17A is a sectional view of another embodiment of an endoscope;
• FIG. 17B is a sectional view of the endoscope taken along the line17B-17B ofFIG. 17A;
• FIG. 18 is a side view of a two-part disposable sheath/illuminator unit;
• FIG. 19 is a schematic of a control unit for a preferred embodiment of the invention;
• FIG. 20 illustrates a preferred method of using the invention;
• FIG. 21 illustrates a preferred embodiment of a portable endoscopic system in accordance with the invention;
• FIG. 22 illustrates a preferred embodiment of an endoscopic in accordance with the invention;
• FIG. 23 is an end view of a sheath;
• FIG. 24A is a schematic view of a preferred endoscopic device;
• FIG. 24B is a cross-sectional view of the insertion portion of the probe; and
• FIG. 25 is a schematic view of another preferred endoscopic device.
DETAILED DESCRIPTION OF THE INVENTION
• An embodiment of the invention is illustrated inFIG. 1 that shows aminiature endoscope20. Theendoscope20 has animaging unit22 and a sheath/illuminator unit24. Theendoscope20 has an image transmission path such as a plurality ofoptical fibers26, as best seen atfibers146 inFIGS. 11 and 12, in anelongated tube28 of arod tip29 used to view objects to be examined. Theoptical fibers26 are optically coupled to animaging device30, such as a charged coupled device as seen inFIG. 9, or other pixilated flat panel sensor, in ahandle32. Adisposable sheath34 of the sheath/illuminator unit24 overlies theelongated tube28 of therod tip29, which contains theoptical fibers26. Thedisposable sheath34 has at the proximal end a base35 with a mountingmechanism36 for securing to thehandle32. In one embodiment, thedisposable sheath34 of the sheath/illuminator unit24 has a plurality of optical fibers for transmitting light to the distal end of thedisposable sheath34 and thedistal probe29. The distal end of the disposable sheath/illuminator unit24 has aconnection38 to connect to alight source40.
• Thehandle32 can house apower input41, used to provide power to theendoscope20. It is recognized that thelight source40 and/or power source can be mounted within thehandle32.
• Thehandle32 can also house animage output42. Theimage output42 provides a connection between an imaging device in theimaging unit22 of theendoscope20 and an electronic storage and/or display device. In one embodiment, the storage device is acomputer44, which is connected to amonitor46. Acontrol unit250 is described in greater detail with respect toFIG. 19.
• As explained below in greater detail theimaging unit22 does not need to be sterilized in that theimaging unit22 does not contact or is in direct exposure to the body. The sheath/illuminator unit24 has thedisposable sheath34 that is asleeve assembly52 that is carried by the base35 secured to theimaging unit22 that overlies theelongated tube28 to create a sterilized barrier. In addition, the sheath/illumination unit24 has a sterilizeddrape52 which is mounted to thebase35 of the sheath/illuminator unit24 and is positioned to overlie the remaining portion of theimaging unit22 to provide a sterile environment.
• Endoscopes and endoscopes with disposable sheaths are described in PCT Application PCT/US00/25107 filed on Sept. 13, 2000 and U.S. patent application Ser. No. 09/518,954 filed on Mar. 6, 2000. The entire contents of the above applications are incorporated herein by reference in their entirety.
• Prior to discussing theendoscope20 in further detail, in order to use theendoscope20, theendoscope20 needs to be positioned in the body to view the desired location. One such method is to insert acannula60 into the body and thread theendoscope20 through thecannula60. One method of inserting thecannula60 into the body and then inserting theendoscope20 into a body using thecannula60 is described below.
• During an insertion procedure, acannula60 such as seen inFIG. 2, is first inserted into a site within a body. Thecannula60 has abase62 and atube64. Thetube64 has ashaft66 which extends from thedistal end68 to a void70 in thebase62. In one embodiment, thetube64 is made of a flexible material such as plastic or thin wall stainless steel. Thecannula60 has aluer72 for insertion of medications or fluids or for attachment to a suction device.
• For insertion of thecannula60 into the body, atrocar76, as seen inFIG. 3, is inserted intocannula60 with arigid shaft78 of thetrocar76 received within theshaft66 of thecannula60. Therigid shaft78 of thetrocar76 extends slightly beyond the distal end of thetube64 of thecannula60 and has astylet80 to cut into the tissue at the surgical site if necessary. Once thecannula60 is positioned at the surgical site, thetrocar76 is removed from thecannula60 and theendoscope20 is installed. Thecannula60 is positioned by the user's hands feeling the location.
• While thecannula60 andtrocar76 are of a relative minimal cost and can be reused after sterilization or disposed of after use, because of several components in theendoscope20 such as components in theimaging unit22, it is not desirous to dispose of theentire endoscope20. Theendoscope20 uses a disposable sleeve orsheath34 to aid in maintaining a sterile environment and reduce or eliminate the sterilization requirements prior to reuse.
• With the method of inserting theendoscope20 into thecannula60 to have the distal end of theendoscope20 at the proper location, previously described, theendoscope20 is described in further detail. Referring toFIG. 4, a perspective view of theendoscope20 is shown. Theendoscope20 has thereusable imaging unit22 and the disposable sheath/illuminator unit24. The disposable sheath/illuminator unit24 has a elongated tube for overlying and encircling theelongated tube28 of theimaging unit22. The elongated tube of the sheath/illuminator unit24 has a sealeddistal end84 and several embodiments includes fiber optics for transmitting the illumination from a externallight source40, such as seen inFIG. 1, to thedistal end84. At the proximal end of the sheath/illuminator unit24 is a base35 with a mountingmechanism36 for securing to theimaging unit22 of theendoscope20. Anoptical pigtail88 projects from thebase35 for connecting to thelight source40. In addition, the sheath/illuminator unit24 has a thedrape52 which is mounted to thebase35 and is extended over thehandle32 of theimaging unit22. Thehandle32 of theimaging unit22 contains optics and theimaging device32 to receive the image transmitted through theoptical fibers26 located in theelongated tube28 of theimaging unit22 as described in further detail below with respect toFIGS. 9-11.
• FIG. 5 is a sectional view of theminiature endoscope20 including thereusable imaging unit22 with imaging anoptical fiber26 and the disposable sheath/illuminator unit24. Thecannula60 is shown overlying thedisposable sheath34 of the sheath/illuminator unit24, which overlies theprobe29 of theimaging unit22.
• As seen inFIG. 5, thereusable imaging unit22 of theendoscope20 is encircled by the disposable sterile sheath/illuminator unit24. The disposable/sheath illuminator unit24 has thedisposable sheath34 that is sealed at thedistal end84 and encircles and surrounds theelongated tube28 carrying theoptical fibers26 of theimaging unit22. The mountingmechanism36 on thebase35 of the sheath/illuminator unit24 is secured to a mountingmechanism92 on theimaging unit22.
• The disposable sheath/illuminator unit24 has thedrape52 which surrounds the handle of theimaging unit22. In addition, the sheath/illuminator unit24 has the illumination pigtail connecting to alight source40 as seen inFIG. 1. Theillumination pigtail88 is optically coupled to the optical fibers in the sheath as explained in further detail below.
• Referring toFIG. 6A, a side view of the sheath/illuminator unit24 is shown. Thesheath unit24 has thedisposable sheath34 with an elongatedouter sheath98 which extends from the base35 to thedistal end84. Theilluminator pigtail88 extends from the base and is optically coupled to illumination fibers within thesheath34 as seen inFIG. 7A. Thedrape52 is carried by thebase35 of the sheath/illuminator unit24 for overlying thehandle35 of theimaging unit22 when the twounits22 and24 are combined.
• FIG. 6B is an enlarged view of thedistal end84 of thedisposable sheath34 of the sheath/illuminator unit24. Thedisposable sheath34 has theouter sheath98 which extends from within thebase35, as seen inFIG. 6A, and serves as protective covering and a sterile barrier for thesheath unit24. Spaced and collinear with theouter sheath98 is aninner tube100 of thedisposable sheath34. Theinner tube100 defines a cylindrical void onspace102 for receiving theelongated tube28 of theprobe29 of theimaging unit22. Theinner tube100 likewise from thedistal end84 of thedisposable sheath34 to thebase35 of the sheath/illuminator unit22. Theinner tube100 extends further than theouter sheath98 to create achannel106 to receive a plurality ofillumination fibers108 as best seen inFIG. 6A and 7A. At the distal end, of theinner tube100 is located awindow110 which is secured to theinner tube100 to make a sterile84 barrier between theairspace102 for receiving theelongated tube28 of theimage unit22 and the outer portion of the sheath/illuminator unit24 which is in contact with the body.
• In a preferred embodiment, theouter sheath98 of thedisposable sheath34 of the sheath/illuminator unit24 is made of a stainless steel material and has an outer diameter of about 0.038 inches. Theinner tube100 is likewise made of a stainless steel material. Theillumination fibers108 are made of a glass or plastic fiber. Depending on the size of the device, the maximum number ofillumination fibers108 used to fillchannel106. In one example, thedisposable sheath34 extends 2.246 inches from thebase35 of the sheath/illuminator unit24.
• Interposed between theouter sheath98 and the inner tube is the plurality ofillumination fibers108 which encircle theinner tube100 as best seen inFIG. 7A and 7B.FIG. 7A is a sectional view through thebase35 of thedisposable sheath24. Theouter sheath98 is shown in the lower half ofFIG. 7A and terminates prior to the portion sectioned in the upper half ofFIG. 7A. Theinner tube100, however, which defines theairspace102 to receive theelongated tube28 of theimaging unit22 extends to a receivingchamber114 as seen inFIG. 6A and therefore is shown in both the upper and lower portions ofFIG. 7A. The light is transmitted from theillumination pigtail88 throughfibers108, as seen inFIG. 6A, to atransmission unit118 as seen in the upper half ofFIG. 7A which abuts theillumination fibers108 located between theouter sheath98 and theinner tube100 of thedisposable sheath34 of the sheath/illuminator unit24.
• FIG. 7B shows thedistal end84 of the disposable sheath/illumination unit24. Thewindow110 overlies and seals theairspace102 that receives theimaging unit22 and is encircled by theinner tube100. Interposed between theouter sheath98 and theinner tube100 is the plurality ofillumination fibers108. In the embodiment shown, the distal end of theillumination fibers108 are not protected and exposed to the body.
• FIG. 8 is similar toFIG. 6A in that it shows the disposable sheath/illumination unit24. In addition,FIG. 8 shows the entire illumination pigtail which is broken away inFIG. 6A.
• Theillumination pigtail88 has aconnection38 for connecting to a connector on thelight source40. Theillumination pigtail88 has a plurality of optical fibers which run from theconnection38 to thefibers108 which transmit the light received from thelight source40 to thetransmission unit118 shown inFIG. 7A and exit at84.
• Referring toFIG. 9, a sectional view of the imaging unit of theendoscope20 is shown. Theimaging unit22 has theprobe29 with theelongated tube28 that extends from thehandle32. At the proximal end of thehandle32, is the imaging device. In this embodiment, a charged coupled device (CCD)30B which converts the optical image into an electrical image is carried in thedetachable housing120A of thehandle32. Interposed between the optical fiber orfibers26 which extend in theelongated tube28 and theCCD30B is a plurality oflenses122A for projecting the image of theproximal end124 of the optical fiber orfibers26 to theCCD30B. Theglass window122B is attached tohousing120B and provides a seal to the scope. It also protects the lenses from contamination.
• Theimaging unit22 enlarges the image from the end of thefiber optic26 and couples it to the charged coupleddevice30B. As indicated above, the charged coupled device is connected to a electronic storage and/or display device such as acomputer44 which is connected to amonitor46 as seen inFIG. 1.
• Thehandle32 of theimaging unit22 has amounting mechanism128 for coupling with the mountingmechanisms36 of thesheath illuminator unit24. The mountingmechanism128 hasslots130 for receiving pins located on the mountingmechanisms36. In addition, the mountingmechanism128 has aprojection134, from which theprobe29 projects, that is received by the receivingchamber114 of the sheath/illuminator unit24 as seen inFIG. 6A.
• An enlarged view of the distal end of theimaging unit22 is shown inFIG. 10A. Therod tip29 of theimaging unit22 has the elongatedtube28 that extends from thedistal end126 to the housing120 of thehandle32. At thedistal end126 of therod tip29 there is in addition atube138 which extends a slight distance from thedistal end126 and just a slight distance beyond the ends of the optical orimage fibers26. Thetube138 is commonly referred to as the long tube in that a shorter andsmaller diameter tube140 which is collinear with thelong tube138 is received within thelong tube138 and extends alens system142 at thedistal end126. The elongated orouter tube128,long tube138 andsmall tube140 are mounted so that their distal ends are flush and are secured by an adhesive such as a modicalgrade epoxy. At the end of theelongated tube28 of theimaging unit22 is thelens system142 that is described in further detail below. Theelongated tube28 of theimaging unit22 is received within the disposable sheath/illumination unit24 and therefore does not need to be sterilized prior to the first use.
• FIG. 10B is an end-view of thedistal end126 of theimaging unit22. Thelens system142, thesmall tube140, thelong tube138 and the outer orelongated tube28 are shown and are all collinear.
• Referring toFIG. 11, a sectional view of theimaging unit22 of theendoscope20 is shown. Theprobe29 of theimaging unit22 has a plurality offibers146 for transmitting the image from thedistal end126 of therod tip29 to thehandle32. Encircling thefiber146 at the distal end of therod tip29 is thelong tube138 for holding thefibers146 of theimage fibers26 in position. The outer orelongated tube28 encircles thelong tube138 and protects thefibers146 of theimage fibers26 from their beginning near thedistal end126 of therod tip29 to the other end within thehandle32. There are typically thousands offibers146 as shown inFIG. 11 that are fused together. The loading of the image into them is done by the distalend lens system142 which as described below arranges the light levels of the image in a relationship to the location of theimage fiber bundle26.
• In addition, the fibers are in a disorder pack method. This disorder pack method limits transmission of images/light from onelens142 to another as theimage fiber bundle26 extends from near thedistal end126 of theimaging unit22 towards the proximal end of the fibers located within thehandle32. The disorder packing of fibers is achieved by varying the doping of the fibers, which is the area to be examined.
• Referring toFIG. 12, a sectional view of the distal end of therod tip29 of theimaging unit22 within thedisposable sheath34 of the sheath/illuminatingunit24 is shown. Thedisposable sheath34 has theouter sheath98 collinear with theinner tube100. Interposed between theouter sheath98 and theinner tube100 is the plurality ofillumination fibers108 as best seen inFIG. 7B for illumination. At the distal end of the disposable sheath is the window that is secured, such as by cementing, to create a boundary to the air space orinner channel102 that receives therod tip29 of theimaging unit22. Theimaging unit22 has the elongated orouter tube28 that extends from thedistal end126 to within thehandle32 as shown inFIG. 9. Located in thedistal end126 of therod tip29 are two additional tubes or sleeves, the shorter inner sleeve, referred to as thesmall tube140, that retains and holds the lens elements of thedistal lens system142. A larger longer sleeve, referred to as thelong tube138, encircles thetube140 and the beginning of thefibers146 of theimage fibers26.
• Thedistal lens system142 as shown inFIG. 12 is an achromatic lens system having a pair oflenses150 and152 and anaperture stop154. Thelenses150 and152 each have aconvex surface156 that faces each other. Thesecond lens152, closer to thedistal end126, has aplanar surface158 which abuts theoptical aperture stop154. Theaperture stop154 and thelenses150 and152 are designed so that the sine of the maximum ray angle approaches the fibers at N.A. (numerical aperture).
• The ray tracings160 inFIG. 12 illustrate the projection of an image off the page to the right at the proper focal length and how this image is translated through theaperture stop154 and through thelenses152 and150 to the plurality offibers146 in theimage fibers26. The lens system is non-telecentric.
• Referring toFIG. 13 a graph of the sign of the maximum ray angle versus the normalized image height for three different lens systems including a prior art lens system is shown. As discussed below, the field of view is dependent upon the lens configuration. The graph inFIG. 13 shows a line for the maximum sign of a ray angle for a 50 degree lens system and a second line for a maximum sign of ray angle of a 70 degree lens system. In the 70 degree system, the maximum sign is approximately 0.32. Therefore, the N.A. (numerical aperture) of the fiber is approximately the same. In contrast, the 50 degree field of view system has an sign of a maximum ray angle of approximately 0.25. Therefore, the fibers have this numerical aperture. The system can provide a field of view at any selected level from 30-80 degrees, for example.
• In one embodiment, theendoscope20 has 10,000 fiber elements. In this embodiment, eachfiber element146 has a diameter of 4.4 microns. The overall diameter of thefiber26 is 0.46 mounting mechanism. The elongated orouter tube28 of the imaging unit is made from stainless steel. It is recognized, that the scope can be formed in many sizes, the following table is merely an illustration of various intervening size scopes.

  	3k	10k	30k	50k	100k

  Sheath/Illumination	1-4	mm	————————————
  unit outer diameter
  Imaging Unit rod	0.5-3.5	mm	————————————
  tip outer diameter

  No. of fiber	3,000	10,000	30,000	50,000	100,000
  elements

  Fiber image			0.46	mm	0.75	mm
  diameter
  Fiber pixel size	4.4	microns	4.4	microns	4.4	microns
  (individual fiber)

  Lens Type	Achromatic or	Achromatic or	Achromatic	Achromatic	Achromatic
  	Selfoc Grin	Selfoc Grin

  Depth of Field		3 mm-20 mm	————————
  (DOF)

  Field of View	Dependent on	————————————
  (FOV)	Lens 50°-70°

• As can be seen from table above, an alternative to an acromat lens described above with respect toFIG. 12 and13 is a selfoc grin lens.FIG. 14 shown an alternative embodiment of therod tip29 of theimaging unit22 of theendoscope20 with agrin lens168. Thegrin lens168 as shown inFIG. 14 is a single element gradient index lens. Therod tip29 of theimage unit22 as shown inFIG. 14 has an elongated orouter tube28 that extends from thedistal end126 to thehandle32, not shown inFIG. 14. In addition, similar to that ofFIG. 10A, atube138 extends a slight distance from thedistal end126. Thistube138 is commonly referred to as the long tube, it extends just slightly beyond the ends of theoptical image fibers26. In contrast to the embodiment shown inFIG. 10A in that thelens170 is a single lens there is no need for asmall tube140 for retaining the elements of a lens system.
• Thegrin lens168 in general does not provide as good of image quality as that of theacromat lens system142 described above in that the image becomes less clear (i.e., blurry and distorted) towards the edge of the image. In addition, the color correction, changes in intensity as a function of wavelength, is not as good as in the acromat lens system. However, theGRIN lens system168 maybe desirable in situations where cost is a higher factor than the overall image quality. In addition, because of thegrin lens170 being a single element lens the depth of fields may be limited. While only 2 different degrees of freedom are shown, it is recognized that lens systems with other fields of view can be made.
• FIG. 15 is a sectional view ofalternative endoscope170. In this embodiment of theendoscope170, theilluminator pigtail172 is a part of thehandle174 of theimaging unit176 and is therefore not part of a disposable sheath/illuminator unit178. Anoptical fiber bundle180 is used for transmitting the illumination light from thepigtail172 to ahandle interface182 in thehandle184 where the light is transferred to alight interface184 on the sheath/illuminator unit178 to transmit light from thehandle184 to thedisposable sheath186.
• FIG. 16A is a sectional view showing the interface.FIG. 16A is a sectional view of the base188 of the disposable/sheath illuminator unit178. The upper portion ofFIG. 16A shows thedrape52 spaced from the base188. The base188 has alight interface184 that receives light from thehandle interface182 carried on thehandle174.
• In addition in the embodiment of theendoscope170 shown inFIGS. 16A-16C, the sheath/illuminator unit178 has one of theillumination fibers190 replaced by a tube orchannel192. Thetube192 which is seen inFIGS. 15 and 16A-16C is capable of receiving a laser fiber. The user passes a laser fiber though thetube190 from the proximal end of theillumination unit178 in the base188 as seen inFIG. 15, to the distal end of the illumination unit so that the user while viewing the image through the imaging fibers and CCD can complete a process using the laser fiber.
• The lower half ofFIG. 16A shows a cross-sectional view through the base188 of the sheath/illuminator unit178 shows thetube192 extending through the base into the annular ring containing theillumination fibers190. Similar to that shown inFIG. 7A,FIG. 16A shows aninner tube194 around which theillumination fibers190 are located. Theinner tube194 defines an airspace through which theprobe29 of theimaging unit176 of theendoscope170 passes.
• FIG. 16B is a sectional view of thedisposable sheath186 showing anouter tube196 of thedisposable sheath186 and circling theillumination fibers190 and asignal hypotube192. Theinner tube194 surrounds theairspace102 which receives theprobe29 of theimaging unit176.FIG. 16C is an enlarged view showing thehypertube192 with its opening to receive the laser fiber in the annular ray containing theillumination fibers190 between theinner tube194 andouter sheath196.
• WhileFIGS. 15-16C do not show acannula60, it is recognized in most uses of theendoscope20 or170, acannula60 can be used for extra protection of theendoscope20 or170.
• Referring toFIG. 17A, a sectional view of analternative endoscope200 is shown. Theendoscope200 has animaging unit202 and asheath unit204. In contrast to the previous embodiments, thesheath204 that is disposable does not include any part of the illumination unit. Referring toFIG. 17A, theillumination source40 is connected to thehandle206 of theimaging unit202 by anillumination pigtail208 similar to that shown inFIG. 15. But in contrast, there is no coupling such that that the light is transmitted to thedisposable sheath204. Rather, as seen inFIG. 17A, theilluminator pigtail208 is a part of thehandle206 of theimaging unit202. Anoptical fiber210 is used for transmitting the illumination light from thepigtail208 to aninterface212 in thehandle206. Theinterface212 is located within thehandle206 and transfer the light to anannular ring214 of a plurality ofillumination fiber216.
• Referring toFIG. 17B, theprobe218 has anouter tube220 and aninner tube222. Interposed between thetubes220 and222 is the annular space for receiving the plurality ofillumination fibers216. Located in theinner tube222, which is similar to theelongated tube28 in the first embodiment, is theimage fiber bundle26. Thefiber bundle26 is spaced from theinner tube222. Along tube224, which extends for a slight distance from thedistal end126 to just beyond the ends of theimage fiber bundle26, is interposed between thefibers26 and theinner tube222.
• In that the sheath is not required to carry illumination to the distal end of therod tip218 in the embodiment shown inFIGS. 17B, thesheath204 has a singleouter layer226. A window curved to avoid retroreflection is secured to the distal end of the singleouter layer226.
• Referring toFIG. 18, a two piece disposable sheath/illuminator unit230 is shown. The endoscope has afirst unit232 of the two piece disposable sheath/illumination unit230, a mounting andcover unit232, that is mounted to thehandle32 of theimaging unit22. The mounting andcover unit232 has adrape52 that extends over thehandle32 of theimaging unit22 and theillumination pigtail88 when used. Thedrape52 is retained on adisposable sleeve234 to hold thedrape52 until positioned over thehandle32. Thesecond unit236 of the disposable sheath/illumination unit230, adisposable sheath236, contains the elongated tube that covers theprobe29. Thissecond unit236 has amounting mechanism238 to secure to thefirst unit232. It is therefore possible to remove the disposable sheath, the second unit,236 and replace it with a new one while keeping thedrape52 that is mounted to the mounting andcover unit232 over the handle.
• FIG. 19 is a schematic of acontrol unit250 for the endoscope. Thiscontrol unit250 has apower source output252, aninput254 for the image from the CCD and alight source256. In addition to aprocessing unit260 for processing the image data, the unit has arecording device258 such as a CD writer to create a storable medium to retain data such as a baseline for the patient.
• The endoscope is used as shown generally in theprocess sequence270 ofFIG. 20. The patient comes to the user/physician's office. The physician or technician uses a double gloved technique where two sterilized gloves are placed on each of the physician's hands. The physician takes the handle/illuminator unit which is not sterilized in one hand and secure the sterilized sheath/illuminator unit with the other hand. The physician then takes the lighting cord and secure the light cord to the pigtail on the disposable sheath/illuminator unit. The power and image output are likewise connected to the control unit. With the endoscope connected to the control unit, the drape portion of the sheath assembly is extended272 over the handle and down the cords to such a length to provide a sterile field. With this completed, the physician takes off the first pair of gloves and is ready to begin the procedure.
• After medicating the site, the cannula with the trocar is inserted into the body by a standard technique of probing with the physician's hand. Once the cannula is in position, the trocar is removed274 and the tip of the endoscope is placed into the cannula. The endoscope is secured to the cannula using a screw or other attachment mechanism. The system is actuated276 and video recording is initiated so that the physician is able to move the cannula in and out and around to position the probe for viewing of the desired site or a monitor. The physician can perform aprocedure278 at the site using other instruments such as a laser scalpel or cautery tool, or electrosurgical tool and/or the operative channel in the probe or sheath assembly. The entire examination or operative procedure can be recorded280 on a video disk or other memory device. The procedure is concluded and the sheath assembly can be disposed282 of and another sterile sheath assembly can be attached284 to the probe for another procedure.
• A preferred embodiment provides multi spectral imaging capability. This embodiment includes the use of a light source and a detector to provide images over the wavelength range of 700 nm-1200 nm. This allows the user to see through blood to observe tissue.
• Another embodiment uses the ultraviolet (UV) region of the electromagnetic spectrum (10 nm-380 nm) to be able to treat tissue. Ultraviolet light in the range of 325-250 nm can pull together and cauterize. Lasers or conventional broadband light sources can be used to provide light to the illumination system. The imaging fiber bindle can also be used for illumination with a beam splitter in the handle to couple light from one or more sources individually or simultaneously to the fiber bundle.
• Embodiments of the invention can be employed in office-based settings for performing diagnostic imaging of interior surfaces of a body. Office-based as used herein refers to locations other than essentially sterile environments such as, by way of example, hospital operating rooms, hospital procedure rooms, rooms proximate to sterilization means such as autoclaves, and the like. Examples of office locations are, but are not limited to, examination rooms at a physician's office, training rooms adjacent to locker rooms in sporting complexes, ambulances, residences, field hospitals, hospital corridors, examination rooms, emergency rooms, office buildings, stores, and the like.
• On site sterilization of the entireminiature endoscope20 is avoided by making all surfaces that directly contact a patient's skin in the vicinity of the insertion site disposable The disposable portions are retained in sterile packaging until they are utilized for a single procedure. The use of disposable components allows theminiature endoscope20 to be employed following accepted standards-of-care guidelines such as those used for routine arthroantesis.
• In addition, theminiature endoscope20 operates as a fluidless system, although fluid can be used if desired. A fluidless system refers to the fact that no liquid media, irrigation or distention fluid (e.g., saline solution) has to be injected into a patient's body in the vicinity of the target area, i.e. the area that will be viewed using the invention. In other words, the miniature endoscope can simply be inserted through a patient's skin, and used to view a target area without requiring additional instruments, injection means, consumable substances and without generating excess hazardous waste, other than the disposable portion, such as would be generated if irrigation fluids were injected into and removed from the target area.
• Thedisposable portion20 may comprise a disposable needle covering employing a transparent window in its distal end. The transparent window prevents fluids from a patient's body from coming into contact with non-disposable portions (e.g., 32) of the system. Nondisposable portions operating in conjunction with thedisposable portion20 may include a thin shaft which slides inside the introducer and contains a fiber optic illumination system for conducting images of the target area to a miniature camera located in ahandle32. The fiber optic illumination system may comprise a protective window and high resolution fiber optics and lens transmission means for conveying images to the camera. The disposable portion may also include a slide port for introduction of surgical instruments or for evacuation of fluids by suction or for introduction of medications to the target area.
• In an embodiment of the invention, a highly portable miniature endoscopic imaging system is provided. The system shown inFIG. 21 is man-portable, in that it can be transported or carried by a person.FIG. 21 illustrates exemplary embodiments of a portableendoscopic system291 comprising, among other things,miniature endoscope20, handle32,imaging unit22,cable290 andlaptop292. InFIG. 21, the endoscopic unit andimaging unit22 are connected directly tolaptop292 by way ofcable290. For example, imagingunit22 may output a video signal that is sent to a video in jack onlaptop292.Laptop292 is then used to enter patient information, session details, and is used to display real-time image data as the procedure is carried out.
• An embodiment of the portable endoscopic system employs a personal computer memory card international association (PCMCIA) card for facilitating coupling of image data tolaptop292. PCMCIA card may be an industry standard card as known in the art, or it may be specially adapted for use with the miniature endoscope. A specially adapted PCMCIA card may include hardware for receiving and processing video signals received from the imaging unit. The output ofPCMCIA card294 may be an industry standard data format for conveying processed image data to a display associated with laptop.
• A portableendoscopic system291 that includes imaging unit or aninterface box32 and aninterface box cable290 for conveying data tolaptop292. Interface box may include more sophisticated imaging, image processing, and data communication hardware and/or software than can be employed inPCMCIA card294 or directly insidelaptop292. Theinterface box296 may be configured to perform real-time image enhancement on data received through the distal end ofminiature endoscope20. Image enhancement may be used to produce images suitable for performing diagnostics while making use of less costly components inminiature endoscope20. By way of example, a GRIN lens may be employed inminiature endoscope20 to provide image data to interface box. Interface box may employ image processing algorithms for enhancing the image quality produced by the edges of GRIN lenses. Interface box may then convey image data tolaptop292 in an industry standard format by way of cable. The system can also include mounting on acart298 for transport, asdisplay295 and alight source system296. The system can include a standard lamp for visible light imaging as well as infrared or ultraviolet light sources for imaging or treatment.
• A generalized architecture can be used including a central processing unit (CPU), which is typically comprised of a microprocessor associated with random access memory (RAM) and read-only memory (ROM). Often, CPU is also provided with cache memory and programmable FlashROM. The interface between the microprocessor and the various types of CPU memory is often referred to as a local bus, but also may be a more generic or industry standard bus. CPU processes and interprets machine-readable, or function-executable, instructions associated with an operating system, user-developed applications, diagnostic tools, patient data hospital servers, health provider computers, and computers associated with remote experts. A graphical user interface (GUI) cab ne used for patient data entry and display as well as image viewing.
• Many computing platforms are also provided with one or more storage drives, such as a hard-disk drives (HDD), floppy disk drives, compact disc drives (CD, CD-R, CD-RW, DVD, DVD-R, etc.), and proprietary disk and tape drives (e.g., lomega Zip™ and Jaz™, etc.). Additionally, some storage drives may be accessible over a computer network such as network-based storage system. The RAM is capable of storing machine-readable instructions and information necessary to operate software applications for processing and displaying image data received from miniature endoscope.
• Many computing platforms are provided with one or more communication interfaces, according to the function intended of the computing platform. For example, a personal computer, laptop, or belt-wearable computer is often provided with a high speed serial port (RS-232, RS-422, etc.), an enhanced parallel port (EPP), and one or more universal serial bus (USB) ports. The computing platform may also be provided with a local area network (LAN) interface, such as an Ethernet card, and other high-speed interfaces such as the High Performance Serial Bus IEEE-1394.
• Computing platforms such as wireless telephones and wireless networked PDA's may also be provided with a radio frequency (RF) interface with antenna, as well. In some cases, the computing platform may be provided with an infrared data arrangement (IrDA) interface, too.
• Computing platforms are often equipped with one or more internal expansion slots, such as Industry Standard Architecture (ISA), Enhanced Industry Standard Architecture (EISA), Peripheral Component Interconnect (PCI), Personal Computer Memory Card International Association (PCMCIA), or proprietary interface slots for the addition of other hardware, such as sound cards, memory boards, and graphics accelerators.
• Additionally, many units, such as laptop computers and PDA's, are provided with one or more external expansion slots allowing the user the ability to easily install and remove hardware expansion devices, such as PCMCIA cards, SmartMedia cards, and various proprietary modules such as removable hard drives, CD drives, and floppy drives.
• Often, the storage drives, communication interfaces, internal expansion slots and external expansion slots are interconnected with the CPU via a standard or industry open bus architecture, such as ISA, EISA, or PCI.
• A computing platform is usually provided with one or more user input devices, such as a keyboard or a keypad, and mouse or pointer device, and/or a touch- screen display. In the case of a personal computer, a full size keyboard is often provided along with a mouse or pointer device, such as a track ball or TrackPoint™. In the case of a web-enabled wireless telephone, a simple keypad may be provided with one or more function-specific keys. In the case of a PDA, a touch-screen is usually provided, often with handwriting recognition capabilities, and in the case of a laptop, a small keyboard and touch-sensitive display may be provided.
• Additionally, a microphone, such as the microphone of a web-enabled wireless telephone or the microphone of a personal computer, is supplied with the computing platform. This microphone may be used for entering user choices, such as voice navigation of web sites, user menus associated with operatingminiature endoscope20, conveying data to remote locations, or auto-dialing telephone numbers. Voice recognition capabilities normally in the form of software may be employed for facilitating speech based interaction with the computer.
• Many computing platforms are also equipped with a camera device, such as a still digital camera or full motion video digital camera which can be used for facilitating collaboration between the person performing the endoscopic procedure and a remote expert that may be guiding the procedure and interpreting results in essentially real-time by way of a networked display device.
• One or more user output devices, such as a display, are also provided with most computing platforms. The display may take many forms, including a Cathode Ray Tube (CRT), a Thin Flat Transistor (TFT) array, a simple set of light emitting diodes (LED), liquid crystal display (LCD) indicators, a heads-up (i.e. hands free) display, or a projection display.
• One or more speakers and/or annunciators are often associated with computing platforms, too. The speakers may be used to reproduce audio instructions. Annuciators may take the form of simple beep emitters or buzzers, commonly found on certain devices such as PDAs and PIMs. Annunciators may be used to alert the operator of system that an error has occurred. These user input and output devices may be directly interconnected to the CPU via a proprietary bus structure and/or interfaces, or they may be interconnected through one or more industry open buses such as ISA, EISA, PCI, etc. The computing platform is also provided with one or more software and firmware programs to implement the desired functionality of the computing platforms.
• A generalized organization of software and firmware on this range of computing platforms. One or more operating system (OS) native application programs may be provided on the computing platform, such as word processors, spreadsheets, contact management utilities, address book, calendar, email client, patient tracking, user menus for operating system, etc. Additionally, one or more portable or device-independent programs may be provided, which must be interpreted by an OS-native platform-specific interpreter, such as Java™ scripts and programs.
• Often, computing platforms are also provided with a form of web browser or micro-browser, which may also include one or more extensions to the browser such as browser plug-ins and configured to facilitate transmission and reception of image data over network.
• The computing device is often provided with an operating system, such as Microsoft Windows™, UNIX®, IBM OS/2™, or AIX®, LINUX, MAC OS™, Sun Solaris™, or other platform specific operating systems. Smaller devices such as PDA's and wireless telephones may be equipped with other forms of operating systems such as real-time operating systems (RTOS) or Palm Computing's PalmOS™.
• A set of basic input and output functions (BIOS) and hardware device drivers356 are often provided to allow the operating system and programs to interface to and control the specific hardware functions provided with the computing platform. Additionally, one or more embedded firmware programs358 are commonly provided with many computing platforms, which are executed by onboard or “embedded” microprocessors as part of the peripheral device, such as a microcontroller or a hard drive, a communication processor, network interface card, or sound or graphics card.
• Various hardware components, software and firmware programs of a wide variety of computing platforms, including but not limited to personal computers, laptops, workstations, servers, web-enabled telephones, and other like appliances can be used. It will be readily recognized by those skilled in the art that the following methods and processes may be alternatively realized as hardware functions, in part or in whole, without departing from the spirit and scope of the invention.
• An exemplary system uses portable system operating in conjunction with a network. A doctor's office containing portable system, a network, a health insurance provider having data storage associated therewith, a hospital server having data storage, a remote expert computer and a network-based storage system.
• The doctor's office employs portable system for performing diagnostic evaluations of one or more patients. Image data obtained from a session may be stored on laptop and conveyed to one or more remote locations by way of network. Network may be any type of network running any kind of network protocol. By way of example, network may be an intranet such as a local area network (LAN) operating within a corporate location or university campus, a metropolitan area network (MAN) operating within a geographic region such as a city and its surrounding suburbs, or a wide area network (WAN) such as the world wide web. In addition, network may run any type of networking protocol such as, for example, transmission control protocol and Internet protocol (TCP/IP), asynchronous transfer mode (ATM), synchronous optical network (Sonet), frame relay, integrated services digital network (ISDN), open shortest path first (OSPF), etc. Network may employ a plurality of links for coupling network elements and locations. Links may be comprised of hardwired links and/or wireless links. Examples of hardwired links are, but are not limited to, coaxial cable, twisted pair cable, optical fibers, etc.; and examples of wireless links are, but are not limited to, radio frequency (RF) such as IEEE 802.11 based links, or free space optical links. Network may also comprise gateways and/or firewalls for providing access to network and for providing protection against undesirable network traffic such as denial-of-service attacks as well as network traffic containing malicious code such as computer worms and viruses.
• Data conveyed from portable system to network may be directed to a health insurance provider. The health insurance provider may archive received data on data storage by way of link for future use. Health insurance provider may employ its own experts, alone or in combination with automated analysis systems, to review data obtained during an endoscopic procedure using the invention. Portable system may also convey data to a hospital server. The hospital server may further include data storage coupled thereto by link. Hospital server may serve as a pooling resource for maintaining data associated with patients having an affiliation therewith. By way of example, if a patient required surgery based on a diagnosis obtained using portable system, the image data could be reviewed by a surgeon prior to, or during, surgery to ensure that proper and complete treatment is rendered in an efficient manner.
• Data obtained using portable system may further be sent to a remote expert computer by way of network. A remote expert, using remote expert computer, may review image data post mortem or in quasi-real-time. The remote expert may provide a second opinion prior to scheduling more invasive procedures or the remote expert may provide the primary diagnosis in situations where a skilled operator is performing the procedure withminiature endoscope20. For example, disaster relief personnel may be on scene at a remote location and performing a diagnostic procedure on a disaster victim. A remote expert may be viewing image data received over a free space satellite network in real-time to direct the on-scene personnel with respect to the diagnostic procedure. The remote expert may then direct an on-scene person to mark an insertion location on a victim/patient, to introduce the needle covering, to maneuver theendoscope20, and then may use real-time data to recommend accurate treatment for the victim without having to be on site. Data from portable system may further be conveyed to network-based storage system. Network-based storage system may serve as secure and redundant storage for image data resident on laptop. In addition, network-based storage system may serve to keep image data in a location that is more readily accessed for replay than if the data were kept solely on laptop. The system and other remote entities may be communicated with using portable system without departing from the spirit of the invention.
• A preferred method for using theminiature endoscope20 in conjunction with portable system to perform diagnostic procedures. In which the transport by cart into an examination room or other site where the procedure will be performed. Then a camera is coupled to the viewing system. Next, an insertion site is prepared on a patient's body. Preparation of the insertion site may include, among other things, marking the site using a medically approved writing instrument, cleansing the area with an antiseptic solution, etc. A disposable needle covering may be coupled to the imaging and viewing system. As previously discussed herein, only disposable portions ofminiature endoscope20 contact the patient so no special sterilization processes need be applied on site. The needle covering ofminiature endoscope20 is then inserted into a target area of a patient. After the needle point is in the vicinity of the target, the imaging and viewing system may be activated. Image data is viewed and recorded using laptop during the diagnostic procedure. When the diagnosis is complete, the needle is withdrawn from the target area. After needle withdrawal, the insertion location may be dressed using sutures, liquid adhesives approved for topical wound dressing, butterfly closures, or conventional small wound dressings such as gauze or bandages.
• Recorded image data can be reviewed by the diagnostician and shown to the patient in the procedure room. After review, recorded data can be archived locally on laptop, on removable storage media, or by way of network-based storage system. In addition, image data long with alphanumeric and/or voice annotations may be sent to one or more remote locations using network. Then the portable system may be returned to its storage location, and the patient immediately discharged after the procedure, since no complex anesthesia was required.
• While exemplary embodiments of the invention have been described and illustrated hereinabove, the invention is not limited thereto. Many alternative embodiments and implementations are possible in light of the disclosure without departing from the spirit of the invention. For example, the portable system may be deployed in a distributed architecture where the user is located at a first geographic location, with a patient and the miniatureendoscope comprising elements20,21 and22 while the laptop display is located a distance away and is coupled to the miniature endoscope by way of a wireless network. In another alternative embodiment, the invention may be deployed in a ruggedized configuration for use in battlefield triage and/or for responding to disasters in remote and rugged locations. In still other embodiments, the portable endoscopic system may be integrated into mechanized conveyances such as trains, ambulances, air planes, ships, vehicles, etc. In yet other embodiments, images generated using the portable endoscopic system may be replayed and used for training purposes. In still further embodiments, the portable endoscopic system may comprise a belt-wearable computer having a short range high bandwidth link to handle for receiving image data. In this embodiment, handle may comprise a self-contained power source such as a rechargeable battery. This embodiment may further utilize a heads-up display worn on a user's head. Such a configuration provides the user with maximum mobility and minimum weight. The belt-wearable embodiment may further communicate with network by way of a wireless link.
• In yet another alternative embodiment, laptop can be replaced with a customized processing device that can take on essentially any form factor and user interface configuration. For example, it may be desirable to have a dedicated processing module having only an on/off switch. When switched on, the customized processing device may gather image data and store it for later review or it may automatically transmit data to a remote location using a wireless RF or free space optical link.
• FIG. 22 illustrates another preferred embodiment of aportable endoscope400 in accordance with the invention including ahandle402 having acamera module404, anoptical coupler406, aprocessor408, awireless communications module410, awireless antenna412, abattery414 and apower regulator416. Also included in the portable system is alight source418 withinhandle402. Thelight source418 preferably comprises an LED assembly such as an EOS™LED fiber optic illuminator available from Edmund Optics, Barrington, N.J. The light source can also comprise one or more laser diodes or a combination of laser diodes and LEDs, a laser or laser diode in the ultraviolet portion of the spectrum can be used to induce fluorescence in tissue for diagnostic purposes or for cautery. The handle can have acontrol panel409 with buttons that the user employs to electrically operate the handle.
• Thecamera404 can a CCD or CMOS imaging sensor such as the TC7040 two megapixel CMOS imaging sensor device available from TransChip Israel Research Center, Ltd. This device includes a 1600×1200 pixel color sensor array that is packaged with a clock, controller, image processor and local SRAM memory in a single chip package. The camera preferably has sensitivity in the infrared portion of the spectrum (750-1000 nm) as well as the visible. For certain applications it is preferable to use an infrared imaging sensor that can detect light in the range of 1500 nm to 1900 nm, for example, as this improves imaging of tissue through blood. An infrared light source as well as spectral orcutoff filters407 for the detector may be needed for certain spectral imaging applications.
• The disposable420 as described previously herein has aport422 for coupling light from the light source into the fiber optic illumination bundle within thecoupler424 of the disposable. The distal end of the sheath can have acutting element425 that can be recessed during insertion and imaging and mechanically actuated by wire or other means to cut a tissue sample from a region of interest within the body.
• Thehandle402 can also include abar code reader442 or other device that uniquely identifies the disposable component being attached thereto. Thebar code440 can be imprinted on the proximal end of thedisposable coupler424 shown inFIG. 23. This bar code can have a radial or rectangular array. A radial array can be scanned past thereader442 while thecoupler424 rotates into the locked position with thehandle402. Alternatively some other electronic identifying and recording device such as a radio frequency identification (RFID) system can be used or a chip with a serial number can be in the disposable. This can be used for safety and record/inventory purposes.
• The wireless module provides for delivery of video from the handle to a receiver in communication with a desktop or laptop computer. Acable405 can also optionally be connected to thehandle402 to provide a connection to the computer and associated display. Adisplay450 can also be integrated directly into thehandle402 for viewing by the user. The video or still images taken with the camera can also be recorded onto removable media such as a compact flash card, CD, DVD, mini DVD or SD card. Compact media can be inserted into a slot in thehandle402.
• For certain applications it can be desirable to use the imaging waveguide to deliver light onto the tissue as well. A beam splitter within the handle can used for this purpose as described previously.
• Thehandle402 can also be configured to dock with abase unit460 that can transmit and receive images and data from theprocessor408 with atransceiver462. The base460 can also be used as a recharger for thebattery414 and can include a communications circuit for a network or internet connection, a facsimile device or standard telephone data connection.
• The disposable can also include a lens at the distal end, or a prism or mirror for side-viewing applications. The disposable can have a length of between 20 mm and 2500 mm depending on the application. For small joints or bones such as the hand or foot smaller lengths are used. For applications such as the hip, longer lengths up to 2500 mm may be used. For imaging applications such as the breast or brain, imaging in the visible portion of the spectrum can be supplemented by imaging in the near infrared or infrared portions of the spectrum. This can be used to supplement mammographic screening. A biopsy can also be used to collect a tissue sample, if needed. Dyes or tissue autofluorescence can also be used with a narrowband light source such as a laser diode emitting at a wavelength in a range of 300 nm to 500 nm, for example. Gallium nitride diode lasers can be used for this purpose.
• FIG. 24A shows a preferred embodiment in which theillumination fibers502 are rigidly attached to thehandle500. The disposable510 is connected withconnector512 to the handle and can include alens520 or a mirror orprism540 for angled or side viewing. A cross-sectional side view of such an embodiment is illustrated inFIG. 24B which is also seen in the sectional view ofFIG. 17B. This embodiment employs adistal window560 on the end of thedisposable sheath204 that is fluidly sealed to the sheath. In this embodiment the window has an outer transparent element orillumination window562 that transmits the illuminating light from thefibers216 in a distal direction as shown bylight rays217,219. Thewindow560 can have a separate inner element orlight collection window564 which receives light returning from the illuminated region of interest. The outer and inner window elements are optically decoupled by alight barrier566 that can be a stainless steel spacer that is attached to both the outer andinner elements562,564 using an adhesive, for example. Theimaging fibers26 receive light collected throughelement564 and focused bylens system225 onto the imaging fibers generally alonglongitudinal axis565.
• FIG. 25 illustrates an embodiment in which abeam splitter554 in thehandle550 optically couples both thelight source552 and theimaging device556 to a single fiber bundle. This provides for illumination and light collection through a single light channel. The light source can be LED source and/or a laser as described previously herein.
• Many changes in the details, materials and arrangements of parts, herein described and illustrated, can be made by those skilled in the art in light of teachings contained hereinabove. Accordingly, it will be understood that the following claims are not to be limited to the embodiments disclosed herein and can include practices other than those specifically described, and are to be interpreted as broadly as allowed under the law.

Claims (70)

1. A fiber optic probe for viewing within a mammalian body comprising:

a handle having an image device, an optical coupler and a connector; and

a disposable sheath that encloses a fiber optic device, the sheath being connected to the handle with the connector and having a diameter of less than 3 mm.

2. The fiber optic probe ofclaim 1 further comprising a battery within the handle.

3. The fiber optic probe ofclaim 1 further comprising a processor connected to the imaging device.

4. The fiber optic probe ofclaim 1 further comprising a light source within the handle.

5. The fiber optic probe ofclaim 4 wherein the light source comprises a light emitting diode (LED).

6. The fiber optic probe ofclaim 5 further comprising red, green and blue light emitting diodes.

7. The fiber optic probe ofclaim 4 wherein the light source comprises a laser.

8. The fiber optic probe ofclaim 7 wherein the laser comprises a gallium nitride diode laser.

9. The fiber optic probe ofclaim 1 further comprising a wireless transmitter that transmits video images to a control unit.

10. The fiber optic probe ofclaim 9, further comprises a wireless transmitter circuit module and an antenna.

11. The fiber optic device ofclaim 1 further comprising a wireless receiver.

12. The fiber optic device ofclaim 2 further comprising of power regulation circuit connected to the battery, a light source, a processor and the imaging devices.

13. The fiber optic device ofclaim 1 wherein the disposable sheath comprises a concentric fiber array having a diameter less than 2 mm.

14. The fiber optic device ofclaim 1 wherein the fiber optic device comprising an imaging fiber bundle that is rigidly connected to the handle, a proximal end of the imaging fiber bundle being optically coupled to the optical coupler.

15. The fiber optic probe ofclaim 14 further comprising a lens at a distal end of the imaging fiber bundle.

16. The fiber optic probe ofclaim 1 wherein the disposable sheath is detachably connected to the handle and the fiber optic device.

17. The fiber optic device ofclaim 1 wherein the disposable sheath includes the fiber optic device that is detachable from the handle.

18. The fiber optic device ofclaim 17 wherein the detachable fiber optic device comprises an imaging bundle and an illumination fiber optic device connected to a light source.

19. The fiber optic device ofclaim 1 wherein the sheath is insertable into a body lumen without a distending fluid.

20. The fiber optic device ofclaim 1 further comprising a base unit that is connectable to the handle.

21. The fiber optic device ofclaim 20 wherein the handle locks with the base unit such that the handle is electrically connected to the base unit.

22. The fiber optic device ofclaim 20 wherein the base unit comprises a battery charger.

23. The fiber optic device ofclaim 20 wherein the base unit comprises a network connection.

24. The fiber optic device ofclaim 20 wherein the base unit comprises a transmitter.

25. The fiber optic device ofclaim 20 wherein the base unit is connected to a facsimile device.

26. The fiber optic device ofclaim 20 wherein the base unit is connected to a computer.

27. The fiber optic device ofclaim 1 further comprising a cable connecting the handle to a computer.

28. The fiber optic probe ofclaim 9 wherein the control unit comprises a computer.

29. The fiber optic device ofclaim 28 wherein the computer comprises a laptop computer and a display.

30. The fiber optic device ofclaim 1 wherein the imaging device comprises a CMOS imaging device.

31. The fiber optic device ofclaim 1 wherein the imaging device detects light in a range of 300 nm to 1900 nm.

32. The fiber optic device ofclaim 1 further comprising an indentification circuit that identifies the sheath.

33. The fiber optic device ofclaim 32 wherein the identification circuit comprises a bar code reader that reads a bar code on the sheath.

34. The fiber optic device ofclaim 32 wherein the identification circuit comprises a radio frequency identification system.

35. The fiber optic probe ofclaim 32 wherein the identification circuit is on the handle.

36. The fiber optic probe ofclaim 32 wherein the sheath comprises an electronic identifier.

37. The fiber optic probe ofclaim 32 wherein the sheath has a serial number.

38. The fiber optic probe ofclaim 1 further comprising a light source that induces fluorescence in tissue that is detected with the imaging device.

39. The fiber optic probe ofclaim 1 wherein the imaging device detects infrared light in a range of 700 nm to 1000 nm.

40. The fiber optic device ofclaim 1 further comprising a cart for transport of a computer display and the probe.

41. The fiber optic device ofclaim 1 further comprising an achromatic lens at a distal end of the fiber optic device.

42. The fiber optic device ofclaim 1 wherein the imaging device detects light in a visible and a near infrared range.

43. The fiber optic device ofclaim 1 further comprising a cutting element to collect tissue sample.

44. The fiber optic device ofclaim 1 wherein the sheath includes a lens, a mirror or a prism at a distal end for side viewing.

45. The fiber optic device ofclaim 1 wherein the sheath is between 50 mm and 2500 mm in length.

46. The fiber optic device ofclaim 1 further comprising a fluid delivery channel for delivering medication or imaging dye to a region of interest in a body lumen or cavity.

47. The fiber optic device ofclaim 1 further comprising a display device on the handle.

48. The fiber optic device ofclaim 1 further comprising a control panel on the handle.

49. The fiber optic device ofclaim 1 further comprising a spectral filter coupled to the imaging device.

50. A method of performing body imaging comprising:

providing a handle having an imaging device;

attaching the handle to a disposable sheath, the sheath enclosing a fiber optic imaging device;

inserting the sheath into the patient; and

viewing a site within the patient without insertion of a fluid at the site.

51. The method ofclaim 50 further comprising providing an illumination source having a wavelength in the range of 700 nm-1200 nm.

52. The method ofclaim 50 further comprising providing a light source having a wavelength in a range of 10 nm to 380 nm to treat tissue in the patient.

53. The method ofclaim 50 further comprising providing a cart for transport of a system including a computer, a display, and a probe storage.

54. The method ofclaim 50 further comprising providing a laptop computer having a graphical user interface to display one or more images and enter patient data.

55. The method ofclaim 50 further comprising providing a light source in the handle.

56. The method ofclaim 50 further comprising viewing the site without a distending fluid

57. The method ofclaim 55 wherein the light source comprises an LED array.

58. The method ofclaim 50 further comprising transmitting image data from the handle to a computer with a wireless connection.

59. The method ofclaim 50 further comprising locking the handle with a base having a battery charger.

60. The method ofclaim 50 further comprising providing a batter, a processor, a wireless transmitter and a light source in the handle, the light source being coupled to a fiber optic array in the sheath.

61. A fiber optic probe for viewing within a mammalian body comprising:

a handle having an imaging device, an optical coupler that optically couples a fiber optic imaging channel to the imaging device, a fiber optic illumination channel, and a connector; and

a disposable sheath that encloses the fiber optic imaging channel, the sheath being connected to the handle with the connector and having a diameter of less than 3 mm the sheath further comprising a distal window.

62. The fiber optic probe ofclaim 61 further comprising a battery within the handle.

63. The fiber optic probe ofclaim 61 further comprising a processor connected to the imaging device.

64. The fiber optic probe ofclaim 61 further comprising a light source within the handle.

65. The fiber optic probe ofclaim 64 wherein the light source comprises a light emitting diode (LED).

66. The fiber optic probe ofclaim 61 wherein the window further comprises an illumination window and a light collection window.

67. The fiber optic probe ofclaim 66 wherein the illumination window is optically decoupled from the collection window.

68. The fiber optic probe ofclaim 67 wherein the sheath is fluidly sealed to the window.

69. The fiber optic probe ofclaim 68 wherein the collection window is decoupled from the illumination window with an optical barrier.

70. The fiber optic probe ofclaim 69 wherein the optical barrier comprises a spacer attached with an adhesive.

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