GB2339539A

GB2339539A - Medical viewing device

Info

Publication number: GB2339539A
Application number: GB9925022A
Authority: GB
Inventors: Richard E Forkey; David M Tremblay; Christopher B Smith
Original assignee: Precision Optics Corp Inc
Current assignee: Precision Optics Corp Inc
Priority date: 1995-10-16
Filing date: 1995-10-17
Publication date: 2000-02-02
Anticipated expiration: 2015-10-17
Also published as: GB2339539B; GB2306329B; GB9925022D0; GB2306329A; GB9521254D0

Abstract

A device for viewing body orifices comprises a handle 12 containing illuminating means connected, by a set screw, to a distal tip 14 which has a lens 24 situated at the proximal end 28 thereof. The handle 12 preferably contains a fibre optic cable 20 which directs light onto the lens 24. The lens 24 preferably has a magnification in the range of 2X-50X and also may contain slots or access ports 26 through which a needle may be passed. The device therefore enables the injection of needles into body cavities to be observed.

Description

2339539

MEDICAL VISUALIZATION DEVICE Background of the Invention

The invention relates to optical medical instruments and in particular to a medical visualization device for medical examination by visualizing of an anatomical area through a body orifice with the ability to perform local therapeutic treatment.

viewing scopes that enable one to view body passages are well known in the art. For medical applications the viewing scopes take many forms and are known by different names. Generically the name "endoscope" means any slender, tubular optical instrument used as a viewing system for examining an inner body part. In particular, such viewing scopes have a variety of names, such as endoscopes, laparoscopes and bronchoscopes.

various medical instruments have been used to examine an anatomical area through a body orifice such as ear, nose, mouth, vagina, urethra, rectum, etc. However, these instruments have not provided access for hypodermic or other therapeutic substance application directly through the viewing chamber.

A well known device is called a sigmoidoscope used in rectal examinations having optical means to aid visualization, but this device uses lenses at both distal and proximal extremities or no lenses at all. Other similar devices are configured for gynecological and otolaryngological examination.

2 Summary it is an object of this invention to provide a medical visualization device for examination of an anatomical area through a body orifice for diagnosis or local therapeutic treatment- It is another object of this invention to provide a medical visualization device having viewing magnification for examination of an anatomical area through a body orifice.

It is still another object of this invention to provide a medical visualization device which provides the means for application of medication through a distal tip of the device.

It is a further object of this invention to provide a medical visualization device having a low-cost disposable distal tip.

The objects are further acco-mlished by a medical visualization device comprising a handle means for providing illumination and facilitating use of the visualization device, a distal tip means attached to the handle means for insertion into an orifice, the distal tip means comprises a lens means, arranged at a proximal end of the distal tip means, for viewing an illuminated area at a distal end- The handle means provides the illumination by transferring light entering the handle at a first portion to a second portion of the handle-the light being emitted adjacent to the lens means. A light source provides light to the first portion of the handle. The lens 3 means provides magnification of the illuminated viewing areaThe distal tip means comprises an access port means for enabling insertion of a needle means for providing therapeutic treatment. The handle means comprises a fiber optic cable for transferring light to the lens means- The light exits the fiber.optic cable in the direction of the lens means at an angle conforming with the slope of the lens means.

The objects are further accomplished by a medical visualization device comprising a handle means for providing illumination and facilitating use of the visualization device, a distal tip means attached to the handle means for insertion into an orifice, the distal tip means comprises an access port means for enabling insertion of a needle-means for providing therapeutic treatment. The handle means provides the illumination by transferring light entering the handle at a first portion to a second portion of the handle, the light being emitted adjacent to the lens meansThe light source provides light to the firstlyortion of the handle- The handle means comprises a fiber-optic cable for transferring light to the lens means. The light exits' the f iber optic cable in the direction of the lens means at an angle ccnforming with the slope of the lens means.

The objects are further accomplished by a medical visualization device comprising a handle having a fiber optic cable light output at a first end and light guide fitting for 4 connecting to a light source on a second end of the cable, a distal tip attached to the handle, the distal tip comprises a lens at a proximal end positioned adjacent to the fiber optic cable light output of the handle, the lens provides magnification of a viewing area at the distal end of the distal tip, and the distal tip comprises at least one access port for enabling an insertion of a needle into the distal tip and guidance to the viewing area. The distal tip is secured to the handle by means of a set screw inserted into the handle enabling the distal tip to be easily removed from the handle after use.

The objects are further accomplished by a method for providing therapeutic treatment with a medical visualization device inserted into a body orifice comprising the steps of providing illumination through a handle with a fiber optic cable, attaching a distal tip to the handle, the distal tip comprises a lens positioned adjacent to the illumination from the handle, and inserting a needle in the distal tip for providing the the rapeutic treatment to a lighted area at the end of the distal tip. The method further comprises the steps of providing a light source to the fiber optic cable and securing the distal tip to the handle with a set screw inserted into the handle to enable the distal tipto be easily removed after use.

Brief Description of the Drawincre

The appended claims particularly point out and distinctly claim the subject matter of this invention. The various objects, advantages and novel features of this invention will be more fully apparent from a reading of the following detailed description in conjunction with the accompanying drawings in which like reference numerals refer to like parts, and in which FIG. I is a view of the invention, partially in section, of a medical visualization device showing a handle and a cross section of a distal tip portion of the device attached to the handle; FIG. 2 is a cross-section of a distal tip along a plane showing a slot in a proximal end for attaching the distal tip to a handle; and FIG. 3 is a front view of handle showing an opening near the top of the handle for-poBitioning the light output end of a fiber optic cable running through the handle.

Referring to FIG. 1 and FIG. 2, a medical visualization device 10 is shown comprising a handle 12 and a distal tip 14. The handle 12 provides for connection to a light source 18 and for transfer of light through the handle 12 via a fiber optic cable 20 passing through the center of the handle 12. The fiber optic cable 20 transfers light to the distal tip 14. The handle 12 is attached to the distal tip 14 by means of a slot 34 in the proximal end 28 of the distal tip 14, as shown in FIG. 2, fitting into grooves 40 near the top of the handle 12.

A set screw is inserted into a threaded hole (not shown) approximately one-half inch (1.27cm) from the top of the handle 12 at a 20 degree angle from the outer surface of the handle 12. When the set screw is tightened it engages the outer wall of the distal tip 14. 15 The length of the handle 12 including a light source guide fitting 22 is approximately 4.723 inches (12cm). The handle 24 is made of aluminum having a knurled surface for a positive grip when in use. The aluminum may be embodied by Type 2024 manufactured by Admiral Metals, of Woburn, MA, USA. The fiber 20 optic cable may be embodied by type N.A..66-.68, size 0.0015 inches (.038mm), core 89%, and clad 11%, manufactured by Electro Fiber Optics, of Marlborough, MA, USA. The distal tip 14 body is made from Delrin (RTM) which may be obtained from AIN Plastics of Norwood, MA, USA. The distal 25 tip 14 is typically 4 inches (10.16cm) in length. It has an outside diameter at the proximal end 28 of 0.8 inches (2.03cm) and at the distal extremity 30 the outside diameter is -7 typically 0.341 inches (8.66mm). The lens 24 is placed into an opening provided in a lens mounting support holder 32 and a cylindrical retainer 36 is positioned against the perimeter of the lens 24 and glued in place.

The distal tip 14 comprises a viewing lens 24 with an anti-reflection coating and may be a single or multiple-element lens arranged at the proximal end 28 of the distal tip 14.

FIG. 1 shows a single viewing lens 24 having a 110mm focal distance and an outside maximum diameter of 0.689 inches (1.75cm). The lens 24 in the present embodiment has a 2.5X magnification. However, magnifications ranging from 2X to 50X may be employed in other embodiments contemplated. The lens may be embodied by glass type BK-7, manufactured by Schott, of Duryea, PA, USA. The lens 24 has a radius first surface of 56.85mm, a radius second surface plano, and a center thickness of 4.Omm. The lens coating comprises a conventional single layer MgFl for visual wavelength and may be embodied by type AR-100, manufactured by Precision optics Corporation, of Gardner, MA, USA.

Referring to FIG. 1 and FIG. 3, the viewing lens 24 is configured so that the eye 16 of a visual observer may see the region at or near distal extremity 30 of the distal tip 14 even by locating the observer's eye 16 a fair distance (such as 1" to 10" (2-54cm-25.4cm) typical) behind the proximal lens 24. The fiber optic cable 20 terminates at an opening 38 at the top of the handle 12, as shown in FIG. 3, which is positioned adjacent to the lens 24, and light is emitted from the polished end of -8the fiber optic cable 20 at an angle conforming with the slope of the lens 24 resulting in negligible backscatter.

The distal tip 14 includes an access means 26, such as one or more openings in the wall of the distal tip 14, to allow the insertion of hypodermic needles to perform injections. one access means 26 is shown in the cross-section view in the Figure, but in the preferred embodiment there are three access means 26 spaced 120 degrees around the perimeter of the distal tip 14. The access means 26 allows a straight needle to be inserted into the distal tip 26 and guided to the distal extremity 30 to accomplish therapeutic treatment. The insertion of the needle into the distal tip 14 access means 26 may be observed in reasonable focus so that the medical visualization device 10 may be used as an aid to the application of a therapeutic substance.

The medical visualization device 10 provides for visualizing an anatomical area through a body orifice such as ear, nose, mouth, vagina, urethra, rectum, etc. in order to perform medical examination for diagnosis or enables local therapeutic treatment by application of therapeutic drugs or other agents to local parts of the body. A person of ordinary skill in the art will recognize that the medical visualization device 10 may, with proper lens assembly and mechanical interface at the proximal end 28 of the distal tip 14, be used to allow visualization by electronic means such as video camera, telemedicine sensor and the like which then electronically provides an image to an observer, such as viewing on a video monitor. Further, another embodiment of the distal tip 14 may be employed without a lens 24 in the proximal end 28.

One important application of the medical visualization device 10 is for diagnosis examination and local therapeutic treatment for female incontinence. As noted above, the length of the distal tip 14 is typically 4 inches (10.16cm) and the diameter of the proximal end 28 is 0.8 inches (2.03cm). The distal tip 14 is sized at an outside diameter of the distal extremity 30 of no greater than standard medical catheter sizing of "26 French" (0.341 inches or 8.7mm) to allow insertion into the urethra to allow the distal extremity 30 (25mm or less from the proximal opening of the urethra) to be in contact or close proximity to the urethral sphincter, controlling urine flow from the bladder. Side access means 26 or ports in the distal tip 14 allow access to the sphincter for injection of "bulking agents" (such as collagen compounds, vulcanized silicone, etc.) to fill out the slackened sphincter muscles. This device 10 provides about 2.5X magnification, and a doctor may view the sphincter with his eye very close or 8 to 10 inches (20.32- 25.4cm) or more distant from the Medical Visualization Device 10. This embodiment may incorporate a reasonable cost, disposable distal tip 14 and a re-usable, sterilizable (even by autoclave), fiber optic handle 12. The fact that the end of the fiber optic cable 20 of handle 12 is located behind the lens 24 of the distal tip 14 and outside any apparent requirement for a "sterile field", may not require -10 sterilization of the handle 12. Further, this embodiment enables the doctor, being shielded from the bladder and sphincter, to complete diagnostic and therapeutic operations with minimum interference from urine discharge.

This invention has been disclosed in terms of a certain embodiment. It will be apparent that many modifications can be made to the disclosed apparatus without departing from the invention. For example, the distal tip 14 may be embodied without a lens 24 thereby providing for direct view of an anatomical area of a body. Further, another embodiment of this device 10 accepts curved needles whereas the present embodiment is for straight needles. Therefore, it is the intent of the appended claims to cover all such variations and modifications as come within the true spirit and scope of this invention.

Claims

1. A medical visualization device comprising:

a handle means for providing illumination and facilitating use of said visualization device; a distal tip means attached to said handle means for insertion into an orifice, said distal tip means comprises an access port means for enabling insertion of a needle means for providing therapeutic treatment.

2. The medical visualization device as recited in Claim 1 wherein said handle means provides said illumination by transferring light entering said handle at a first portion to a second portion of said handle, said light being emitted adjacent to said lens means.

3. The medical visualization device as recited in Claim 2 wherein a light source provides light to said first portion of said handle.

4. The medical visualization device as recited in Claim I wherein said handle means comprises a fiber-optic cable for transferring light to said lens means.

5. The medical visualization device as recited in Claim 4 wherein said light exists said fiber optic cable in the direction of said lens means at an angle conforming with the slope of said lens means.