Bala Laparoscope System

Abstract

The Bala Laparoscope System is a reusable and/or disposable embodiment of a modular, surgical laparoscope with removable interchangeable viewing angles that enable one laparoscope to be used in place of two separate conventional laparoscopes with different viewing angles. The invention provides for distal lens cleaning without removing the laparoscope from the body. In addition, the invention provides for integrated image-guided working channels for surgical tools; cauterization and laser ablation and internal drug delivery. The simplicity of its optical design allows a much longer useful instrument life than conventional laparoscopes and essentially eliminates the need to rebuild them.

Claims

1. A modular laparoscope assembly comprising: a telescope assembly having a proximal end and distal end, each having interchangeable elements at both the distal and the proximal ends of the device as a means of viewing an image through an optical telescope with an electronic camera and/or an eyepiece; a separate illumination system with both interchangeable reusable and disposable illumination means in which the objective lens at the distal end of the laparoscope can be cleaned without removing the laparoscope from the body, in addition to providing interchangeable angular viewing, internal drug delivery, and surgical working channels integrated with the telescope illumination.

2. The laparoscope assembly of claim 1 comprising a reusable lens tube with a series of two glass anti-reflection coated achromatic lenses, a field stop, and three anti-reflection coated singlet glass lenses fixed in place by individual spacers of specific lengths to create a telescope of 307 mm in length.

3. The laparoscope assembly of claim 1 comprising a reusable proximal assembly of individual optical fibers dispersed and cemented around the circumference of the telescope to create a light halo ring with the other end of the optical fibers bundled together at a ferrule.

4. The laparoscope assembly of claim 1 comprising an eyepiece assembly constructed of metal or plastic with a coated glass achromatic doublet lens that can be adjusted for focus and then permanently fixed to a metal or plastic proximal housing.

5. The laparoscope assembly of claim 1 comprised of a metal or plastic C mount with a mechanical male thread to accept an electronic camera. The assembly is designed to focus a camera by sliding it on the lens tube to its focus position. A slotted taper and second male thread is compressed by a matching taper and female thread that locks the camera assembly to the lens tube

6. The laparoscope assembly of claim 1 comprising a disposable telescope with a lens tube constructed from a plastic material, Poly Ether Ether Ketone (PEEK), with two anti-reflection coated glass achromatic lenses, field stop and three anti-reflection coated singlet lenses, fixed by individual spacers of specific lengths, wherein the singlet lenses can constructed with a optical grade acrylic and or cyclic polyolefin.

7. The laparoscope assembly of claim I comprising of two disposable halves of molded Nippon Zeon 5000 optical grade cyclic, polyolefin injection molded to create a fiber optic equivalent light halo that surrounds the telescope lens tube and is tapered tapers to form a ferrule. Nippon Zeon 5000 is preferred because of its high transmission, and because it distorts at temperatures used to autoclave medical devices, thus preventing its reuse. Other similar materials with equivalent performance are acceptable.

8. The laparoscope assembly of claim 1 comprised of a reusable bundle of individual optical fibers sandwiched between two stainless steel cylinders, optically ground and polished at both the distal and proximal ends, and with a metal or plastic flange that interlocks to the proximal housing to assist in insertion and removal and rotation, and a sealed zero power lens or prism lens at the distal end.]

9. The laparoscope assembly of claim 1 comprised of a complex prism located at the distal of end claim 8 in which the front and back surfaces of the prism are at different angles.

10. The laparoscope assembly of claim 1 wherein a disposable plastic cylindrical lumen made of Nippon Zeon 5000 optical grade plastic material with an outer diameter of 10 mm and an inner diameter that slides over the outer diameter of the telescope to contact the lens halo of claim 3 with a zero power lens or prism sealing the distal end.

11. The laparoscope assembly of claim 1 wherein a disposable opaque barrier between the outer diameter of the zero power lens or prism and the inner diameter of the lumen isolates imaging from illumination.

12. The laparoscope assembly of claim 1 comprised of a disposable plastic flange with tabs at the proximal end of the lumen that interlocks with the telescope's proximal housing in order to insert, remove and rotate the lumen.

13. The laparoscope assembly of claim 1 wherein the cylindrical inner and outer diameters of claim 10 are made of a high index optical grade plastic; and the air interface of the inner and out diameter serves as a low index cladding.

14. The laparoscope assembly of claim 1 comprised of a approximately 0.5 mm channel located between the inner and outer diameters of claim 10 that is inserted into a flange assembly at the proximal end of the lumen that mates with a stainless steal tube and housing, containing a polyurethane diaphragm slotted in a manner to allows a syringe to be inserted.

15. The laparoscope assembly of claim 1 comprised of a disposable diffuser attached at the distal end of the 0.5 mm channel of claim 14 whose purpose is to disperse air and fluid to clean the objective lens or prism at the distal end of the lumen of claim 10.]

16. The laparoscope assembly of claim 1 comprised of a disposable syringe of saline or other solution injected through the diaphragm cited in claim 14 used to clean the objective element of claim 15 at the distal end of claim 10 from the proximal end claim of 14.

17. The laparoscope assembly of claim 1 comprised of a disposable hypodermic needle located at the distal end of the lumen of claim 10 and integrated with the delivery system of claim 14 to permit the injection of a drug through the lumen from the proximal end to a hypodermic needle located at the distal end of the lumen.

18. The laparoscope assembly of claim 1 comprised of one or more disposable lumens with diaphragms designed to seal the entry into the lumen to prevent escape of fumes or particulate at the proximal end that occur when they are used for working channels, laser ablation, cauterization or other surgical devices.

19. The laparoscope assembly of claim 1 comprised of one or more disposable lumens with diaphragms designed to seal the entry into the lumen that can be used to exhaust fluids, fumes and/or blood and tissue during surgery.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1 is an orthogonal view of the embodiment of the Bala Laparoscope System with interchangeable Illumination Adapters.

[0037] FIG. 2 is a lateral view of the telescope with a view of an embodiment without an eyepiece.

[0038] FIG. 3 Is a lateral view of the laparoscope with an eyepiece.

[0039] FIG. 4 Is a lateral view of the disposable telescope without an eyepiece.

[0040] FIG. 5 is a lateral view of a reusable zero degree Illumination Adapter.

[0041] FIG. 6 is a lateral view of a reusable 30 degree Illumination Adapter.

[0042] FIG. 7 is a lateral view of the disposable zero degree plastic lumen adapter.

[0043] FIG. 8 is a lateral view of the disposable 30 degree plastic lumen adapter.

[0044] FIG. 9 is a lateral view of a disposable zero degree plastic lumen adapter with means for cleaning the distal objective lens.

[0045] FIG. 10 is a lateral view of a disposable 30 degree plastic lumen adapter with provisions for cleaning the distal objective prism.

[0046] FIG. 11 is a lateral view of a disposable zero degree plastic lumen adapter with provisions for injecting drugs distally into the body from a proximal insertion source.

[0047] FIG. 12 is a lateral view of a disposable plastic lumen adapter with working channels for laser and surgical therapy.

DETAILED DESCRIPTION OF THE INVENTION

[0048] A preferred embodiment of the invention illustrated in FIG. 1 is a laparoscope consisting of two separate elements, a telescope 1 and interchangeable illumination adapters 2.

[0049] The illustration of the telescope 1 is shown with an eyepiece for either human viewing or connection to a video camera for viewing with a video monitor. The telescope 1 has several embodiments: In one embodiment the telescope is reusable and utilizes an eyepiece. In a second embodiment, a reusable telescope 1 eliminates the eyepiece and utilizes a direct electronic camera adapter. In a third embodiment, the telescope 1 is disposable with an eyepiece. In a fourth embodiment, the telescope 1 is disposable without the eyepiece.

[0050] When using a video camera with the laparoscope 1, a separate auxiliary optical device attached to the eyepiece is required to capture the image and refocus it onto a video camera. The auxiliary optical device and video camera are not shown in the illustration as it is established art.

[0051] Illumination adapters 2 are interchangeable light transmitters that slide over the body of the telescope 1 to transmit illumination light from the proximal end to the distal end of the telescope 1 to complete the laparoscope for its intended use.

[0052] In the embodiment, the Illumination Adapter 2 also has other embodiments consisting of different angles, light transmission materials, drug delivery means, lens cleaning and working channels.

[0053] FIG. 2 is a lateral view that describes the preferred embodiment of the telescope 1 optical system and its physical assembly that is approximately 307 mm in length, Lens #1 3 is an achromatic doublet objective lens, used in conjunction with Lens #2, 4 a singlet comprise the objective lens system. A field stop 5 is located 5 mm from the objective lens #2 4. Lens #3 6 a singlet lens, is the first of a series of relay lenses and located 50 mm from the field stop 5. Lens #4 , 7 is an achromatic doublet lens that relays the image from lens #3 6 to lens #4 7 a distance of 115 mm. Lens #4 7 relays the image 116 mm to lens #5 12, a singlet at the exit of the optical system. In the preferred embodiment all lenses are anti reflection coated with magnesium fluoride. Anti reflection coatings with equal or greater performance would be acceptable.

[0054] In one embodiment of the fiber optic illumination system, light from an external source 11 is directly transmitted to the fibers in a ferrule 10 creating an assembly of bundled fibers 9 which create a light halo ring of fibers 8 around the telescope tube 14 and are encapsulated by the proximal housing 13.

[0055] In one embodiment, the proximal assembly provides the means to connect the telescope housing 13 directly a video camera, eliminating the eyepiece by means of a threaded focusing assembly consisting of parts 14, 15, 16 and 17. A video camera C mount 16 on the assembly is threaded onto a video camera that slides over the proximal housing 13. The focusing assembly slides back and forth on the housing as a focusing adjustment.

[0056] In the preferred embodiment, releasing the pressure on the C mount taper 17 by turning the locking mechanism 14 counterclockwise allows the assembly to slide in an out to visually focus the camera by an image on a video monitor. Turning the the locking mechanism clockwise 14 causes the threads on the focus assembly 15 to apply pressure to a split taper 17 clamping the C mount to the proximal housing 13, thus, locking the camera in place. Other embodiments can provide a similar means of adjusting a camera's focus.

[0057] FIG. 3 is a lateral view that shows an embodiment of the telescope with a eyepiece configuration 18. attached to the proximal housing 13. The eyepiece assembly 18 is constructed with achromatic doublet lens 19 and is focused by sliding the eyepiece assembly 18 onto the proximal assembly 13 until the best possible image is achieved. Prior to insertion of the eyepiece 18, a quick drying cement or epoxy is applied to the proximal assembly 13 and the core of the eyepiece 18 and secured until the cement is cured. The illustration also indicates the different spacers 21 between lenses 3,4, the field stop 5 and lens 6,7 and 12. The embodiment the illumination system is identical to 8,9,10,11,13 & 14 of FIG. 2.

[0058] FIG. 4 is a lateral view illustrates a disposable embodiment of the telescope 1. In the embodiment, the telescope consists of glass lenses #1 3, lens #2 4 , field stop 5, lens 6, lens 7 and 12. In the preferred embodiment , the spacers 26, 27, 28, 29 and 30 between lenses are made of black pigmented Poly Ethel Ethel Ketone (PEEK). In a preferred embodiment, the lens tube 14 that retains the optical and spacer components is also made of PEEK material, but is pigmented for aesthetic purposes.

[0059] In the preferred embodiment, the light halo ring is constructed of a high transmission optical plastic, preferably Nippon Zeon 5000 cyclic polyolefin that is injection molded as a two piece assembly to surround the lens tube 14 to create a light halo 8 at the proximal assembly 31. The two piece illumination assembly 35 is cemented together with an index matching cement to construct a singular assembly around the lens tube 29. The preferred plastic material Nippon Zeon 5000 is selected for the illumination assembly 35 because of the plastic's high optical transmission properties and its ability to distort at autoclave temperatures, preventing the reuse of the telescope assembly for medical purposes. Other equivalent plastics materials of equal or greater performance would be acceptable.

[0060] In the preferred embodiment, the proximal body component is of a two piece clam shell 31 construction with the ferrule 34 and illumination assembly 35 integrated into the clam shell. In an embodiment, the camera mounting assembly components, 32 and 33 are of molded PEEK construction. In the embodiment increasing, pressure by tightening assembly 32 forces the segmented taper of 33 to clamp against the proximal body 31 to retain camera focus position. Releasing the pressure on assembly 32 allows assembly 33 to slide to a new focus without a separate auxiliary optical system.

[0061] FIG. 5 is a lateral illustration of a reusable zero degree Illumination Adapter 2. The Illumination Adapter 2 slides over the telescope assembly 1 until the proximal end of the adapter 39 physically contacts the light halo 8. This occurs when the flange 38 interlocks to the telescope proximal assembly 13.

[0062] The Illumination Adapter 2, fiber optics are the length of the adapter 2 and are hermetically sealed at both ends. At the distal end a zero power lens 34 seals the inner diameter of the adapter. The inside and outside diameters of the adapter are constructed of stainless steel cylinders, 35 & 37 to cover the individual fiber optics 36 sandwiched between them. In another embodiment, these retainers may be constructed of other materials, be they metal or plastic.

[0063] FIG. 6 is a lateral illustration of the embodiment of the Illumination Adapter 2 with a thirty (30) degree prism 40 sealing the distal end. In this embodiment, a compound prism 40 provides an off axis viewing angle of 30 degrees. A compound prism with the outer and inner surfaces are different as this is necessary to prevent the height of the prism 40 from interfering with the field of view of the telescope 1.

[0064] In an embodiment, the distal illumination fibers 42 are cut, ground and polished at the same angle as the prism 40. The proximal end 39 is polished flat and contacts the proximal light halo 8 on the proximal assembly 13. A large number of individual fiber are contained within the same stainless steel structure 41 & 43.

[0065] In an embodiment, the angled adapter is constructed with a flange assembly 44 with tabs 45 located preferably on the center line of the prism 40 to provide external visual orientation. The tabs 45 on the flange provide a means of continuously rotating the prism 40 through 360 degree of rotation. The flange assembly 44 also provides the means of retaining the adapter and for inserting and removing the adapter 2 from the telescope 1.

[0066] FIG. 7 is a lateral view of the embodiment of the fiber optics bundle 46 used to construct the Illumination Adapter 2. The fibers are randomly wrapped along the length the inner diameter cylinder 48. The outer cylinder covers the exposed fiber assembly 47. The hollow core 49 slides over the telescope 1. The proximal end 39 contacts to the light halo 50. In an embodiment with the prism the fiber optics are constructed similar manner but surround the prism.

[0067] FIG. 8 is a orthogonal illustration of the embodiment of the proximal fiber optic assembly 9 contained inside of the proximal housing 13. The fiber optic elements 9 are wrapped around the telescope tube 52 and retained by a retaining ring 51. The individual fibers are cemented together and ground and polished to a smooth finish at both ends of the assembly. A second retainer 53, holds the entire bundle of fibers in a single grouping and are cemented together to form a solid assembly for insertion into the ferrule 10.

[0068] In an embodiment of a disposable fiber optic assembly 9, the light halo 50 is made up of molded cyclic polyolefin (Nippon Zeon 5000) an high transmission optical grade plastic in which one end surrounds the telescope tube 52. A preferred means of assembly is to cement two (2) elements of the plastic assembly 9 around the telescope tube and encapsulate the assembly in the proximal housing 39 and molded to fit the input to the ferrule.

[0069] FIG. 9 is a lateral view of the disposable zero degree plastic Lumen Adapter 2. In place of a stainless steel Illumination Adapter 2. Similarly, the disposable plastic Lumen Adapter 2 slides over the telescope assembly 1 until the proximal end 39 is in physical contact with the light halo 8 and interlocks with the flange 56 on the telescope 1 proximal assembly 31. The disposable Lumen Adapter is compatible with both the reusable or disposable telescope 1.

[0070] The embodiment of a lumen consists of a 10 mm outer diameter 55 and an inner diameter of approximately 8 mm 63. Co extruded between the inner and outer diameters 55 & 63 is an open pathway of approximately 0.5 mm in diameter 54 that runs the length of the lumen.

[0071] In the embodiment, the adapter 55 is constructed transmit light from the proximal 39 to the distal end 81. The lumen 55 is also designed to clean blood and tissue from the distal lens 34 without removing the laparoscope from the body. In a preferred embodiment a cleaning solution such as Saline or other cleaning liquid is injected, with a syringe into the slot 59 in the diaphragm assembly 58 and into the stainless steel tube 61 that interfaces with the 0.5 mm pathway 54 into the body. The flange assembly consisting of 57, 58, 59 60 & 61 create a means of injecting the saline into the collapsible opening 59 in the proximal flange assembly 56 and conveys the cleaning solution into the 0.5 mm pathway 54 and have it exit at a diffuser 80 at the distal end.

[0072] In practice, as the fluid displaces the air that is in the 0.5 mm pathway 54, air pressure is built up as fluid replaces the air creating an air flow over the lens to blow away particulate that may have attached itself to the lens 34. In the embodiment, air and fluid act in sequence under pressure by the action of a syringe.

[0073] In an embodiment, a retainer 58, holds a polyurethane membrane 58 captured inside of the retainer 58 and held under compression. The membrane 58 is slit 59 to allow a syringe to be inserted through the membrane 58 allowing access to the stainless steel tube 61 that allows access to the 0.5 mm pathway 54 transiting the length of the lumen 55. The membrane 58 encapsulates the syringe, preventing back flow from the pressure exerted by the syringe. In an embodiment, the flange 56 provides a means of locking the adapter 55 in place and a molded tab 62 provides a means of rotating the assembly to a convenient place to inject the fluid.

[0074] FIG. 10 is a lateral view that illustrates the embodiment of the angled version of the disposable Lumen Adapter 2. A 30 degree cylindrical prism 40 at the distal end is surrounded by the plastic illumination cylinder 66 used to transmit light from the light halo 8 into the body cavity. The diffuser 64 is at the same angle as the prism 40 to disperse the air and saline over the surface of the prism 40 and angled lumen 66. An embodiment of the flange 56 assembly as a means of injecting saline with a syringe uses the same assembly of 56, 57, 58, 59, 60 and 61 make up the embodiment of the injector mechanism.

[0075] The flange 56 and the tab 62 serve two purposes. The flange 56 enables 360 degrees of continuous rotation of the prism around the lens tube 11 to provide a means of viewing a circular area in the body cavity corresponding with the field of view of the telescope as defined by the prism 40. The rotation also provides a means of positioning the membrane 58 to insert a syringe containing saline.

[0076] FIG. 11 is a lateral view of an illustration of an embodiment of a disposable Lumen with a syringe 67 located at the distal end of the lumen 68. The lumen 68 and the telescope 1, in an embodiment, allows a surgeon to view where a drug is to be injected. Once a determination is made, a syringe located at the proximal end is inserted through a slit 59 in the poly urethane membrane 58 into the path way 61 into the body cavity. The syringe is depressed until the air is removed from the lumen and the drug is present at the distal hypodermic needle 67. This is visualized in the body through the telescope 1. The hypodermic needle at the distal end 67 is then injected into the tissue at a location determined by the surgeon as it is monitored through the telescope 1. Upon completion of the the injection, the telescope 1 and drug lumen 68 are removed from the body cavity.

[0077] FIG. 12 is lateral view of an illustration of an embodiment of a disposable Lumen Adapter for use with a working channel. A second lumen 74 provides a working channel whose diameter is determined for the specific surgical function. For example; a Lumen Adapter can guide a fiber optic that carries a laser fiber, a surgical cutting tool, cauterization device or stapling device. The laser fiber optic or surgical tool enters through a diaphragm 71 through the length of the lumen 74 and beyond. The laser fiber or working device are visually directed from the telescope 1. The diameter of the combined lumens 74 and 79 has sufficient clearance to transit a trocar opening. Once a procedure has been completed and the therapeutic device is removed from the body, the lumen can then also be used to evacuate smoke, solids or fluids from the body by connecting a evacuation system to the lumen's diaphragm 71 and exit port 70.

[0078] While the Bala Laparoscope System has been particularly shown and described with references to the preferred embodiment thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the inventions that is defined by the appended claims.