WO2001000080A2

WO2001000080A2 - Safety sheaths for endoscopes

Info

Publication number: WO2001000080A2
Application number: PCT/US2000/017930
Authority: WO
Inventors: Jeffrey S. Jones
Original assignee: Jones Jeffrey S
Priority date: 1999-06-29
Filing date: 2000-06-29
Publication date: 2001-01-04
Also published as: AU5778500A; CA2375953A1; WO2001000080A3

Abstract

Safety sheaths for endoscopes are provided. One safety sheath (30) has an elongated hollow sheath (36) having a first end (32) and a second end (38) and having a wall of flexible material between the first and second ends. The sheath is compressed before the sheath is placed over the endoscope. When the endoscope (10) is inserted into a patient, the sheath opens, thereby covering the endoscope. The covering (30) also has an endcap (40) for inserting the endoscope and a ring (96) attached to one of the first and second ends of the sheath. When the endoscope is removed from the patient, the sheath inverts, thereby retaining the contaminants on the inside of the sheath. Another version of the safety sheath has two sheaths, an inner (136, 336) and an outer sheath (236, 436). This provides added safety and prevents the operator's hands from contamination with body fluid. Still another version of the safety sheath has a drape (200) having an inlet (202, 204) for an endoscope and a finger access. Also provided is a moveable sheath (536) that fits over an endoscope. The moveable sheath is particularly useful for inserting the endoscope into, and removing the endoscope from, the patient.

Description

SAFETY SHEATHSFORENDOSCOPES

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 USC §119(e) to U.S. provisional patent application serial no. 60/141,408, filed June 29, 1999, the entirety of which is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention is directed to medical instruments and more particularly to conventional endoscopes. The present invention is specifically directed to a sanitary disposable protective covering for an endoscope. The covering shields the endoscope from contact with the patient's body. The covering also protects the operator by preventing contact between patient contaminants and the operator.

BACKGROUND OF THE INVENTION It is an axiom of medicine that medical instruments invading or associating with a patient's body should be extremely clean, if not sterilized. This is particularly true with instruments such as endoscopes, which pass through a body orifice such as the urethra or anus. For purposes of the present invention, the term endoscope is intended to refer to a conventional endoscope, which includes an elongated substantially cylindrical portion, which portion is designed to enter a body cavity for examination and surgical purposes.

All conventional endoscopes currently used in the market today include an elongated substantially cylindrical portion. One reason for this is to allow the distal end of the elongated portion to freely articulate.

Typically the operation of an endoscope requires the use of two hands. One hand, the insertion hand, is used to insert the endoscope into the patient. The other hand, the non-insertion hand, is used to hold the endoscope steady during the insertion and operation of the endoscope. To ensure a good grip and the requisite amount of dexterity, the operator's non-insertion hand should hold the naked, i.e., unsheathed, endoscope.

Unless these instruments are sterilized between use, the opportunities for passing disease-bearing organisms between patients is enhanced. Sterilizing medical instruments generally requires gas sterilization. The process usually takes twenty-four hours and, as such, is not practical for instruments used several times a day. As a result, many instruments are soaked in a germicidal solution that is of questionable efficacy. The soaking takes at least ten minutes, which is advantageous over the gas sterilization process. However, the germicidal solutions tend to be caustic and cause premature destruction of the medical instruments.

Several alternatives are contemplated to resolve this problem. For example, applicant'sU.S. Patents 5,201,908 and 5,386,817 ("the Jones patents"), both of which are incorporated herein by reference for a description of endoscopes, describe the problems associated with keeping endoscopes clean or sanitized, and the use of disposable endoscope sheaths for protecting the endoscope from septic conditions. Advantages of the endoscope sheath are that it is inexpensive and disposable, and it eliminates the need for high level disinfection of the endoscope. Endoscope sheaths can also prevent the portion from which the endoscope is controlled, i.e., the control portion, from being contaminated by the endoscope operator.

The following patents describe endoscope control sheaths. U.S. Patent No. 5,359,991 to Takahashi et al. discloses a sheath to prevent an endoscope from coming into direct contact with the patient's body. U.S. Patent No. 5,359,991 is particularly concerned with contamination that could occur during the removal of the sheath. The sheath is made of a stretchable and flexible material, such as silicone rubber, and covers the insertion part and control part of the endoscope. The sheath has two securing means, one for securing the sheath to the proximal end of the insertion part and the other for securing the sheath to the control part. In one embodiment of the invention, the insertion part of the sheath has an opening for supplying air into the sheath in order to inflate it. Another embodiment of the invention has a fluid supply tube. However, the end of the tube protrudes through the distal end of the sheath. The invention allows for the endoscope operator to open and close a channel formed by the tube.

U.S. Patent No. 5,556,367 to Yabe et al. discloses a cover-type endoscope apparatus. The sheath can be used for a variety of endoscopes which have different lengths. The sheath includes means for connecting the sheath to the endoscope. In one embodiment of the invention, the means for connection is an elastic material. Another embodiment of the invention has two means of connection one for the insertion portion of the endoscope and the other for the operation or control portion of the endoscope. A flexible accordion-like tube is used to control any excess length in the sheath. In another embodiment of the invention, the insertion portion sheath can be slipped into the operation portion sheath, thus controlling the overall length of the sheath. This sheath does not provide for any instrument channels or any means to ensure visual acuity at the distal end of the insertion portion of the endoscope.

U.S. Patent No. 5,363,843 to Daneshvar discloses an endoscope cover and a method for using the disclosed endoscope cover. Generally, the cover is made of latex to prevent patient contamination and consists of three parts. The first part slides over the insertion portion of the endoscope, the second part covers the control portion of the endoscope and the third part covers the cables of the endoscope. However, the three parts can be secured together with an adhesive that will then form a leak-proof connection. U.S. Patent No. 5, 413,092 to Williams et al. describes an endoscope sheath which can be incorporated into a cover for covering the entire endoscope. This sheet has a lens cover portion of a pre-determined thickness that minimizes light reflection into the field of the vision of the endoscope.

U.S. Patent No. 5, 458,132 to Yabe, etal. describes a covered endoscope with an additional second cover member that overlaps and shields a margin of a first cover membrane. This prevents damage to the insertional part shield caused by frictional force by the other member. Additionally, U.S. Patent No., 5,554,098 to Yabe, etal. describes a sheath-like cover which covers both the insertion and operation sections of the endoscope. Furthermore, U.S. Patent No. 5, 993,380 to Yabe describes a disposable protection cover that covers the insertion section of the endoscope with a conduit channel forming.

U.S. Patent No. 5,239, 935 to Takahashi describes a sheath which can be fitted over the insert part of the endoscope. Its cover is made of a shape-memory synthetic resin material that is restored to a previously memorized shape by heating it to a shape restoration temperature. Furthermore, a lock device is provided on the distal end cover and is disengaged when the distal end cover is restored to the memorized shape.

U.S. Patent Nos. 5,217,001 and 5,353,783 X Nakao et al. describe an endoscope sheath that is attached to a cap member, a securing component, which helps facilitate attachment to the distal end of the insertion member of the endoscope. The sheath may be removably disposed about such insertion member and retained on the insertion member by inflating an annular balloon to substantially surround same prior to insertion of the insertion member into a patient.

SUMMARY OF THE INVENTION

The invention, which is defined by the claims set out at the end of this disclosure provides an endoscope covering that is inverted when the endoscope is removed from the patient. An exemplary covering of this nature is a protective covering adapted for use with a conventional endoscope, the covering including an elongated hollow sheath having a first end and a second end and having a wall of flexible material between the first and second ends, wherein the sheath is compressed from end-to-end before the sheath is placed over the endoscope; an endcap wherein the endoscope inserted into the endcap; and a ring attached to one of the first and second ends of the sheath.

This exemplary covering can be attached to a patient at the ring on one end of the sheath. The compressed sheath opens as the endoscope is inserted into the patient' s body cavity, thereby eliminating the need to cover the endoscope before inserting it into the patient.

Another exemplary covering of this nature also includes a second elongated hollow sheath having a first end and a second end and having a wall of flexible material between the first and second ends, wherein the first and second sheaths are adhered to the endcap

Still another exemplary covering also includes a second elongated hollow sheath having a first end and a second end, wherein one of the first and second ends is flared, and wherein the second sheath has a wall of flexible material between the first and second ends; wherein the first sheath is attached to the second sheath at the flared end and the second sheath adhered to the endcap. The exemplary covering having two sheaths allows one sheath to be enclosed the other sheath, thereby containing contaminants and preventing their spread to an operator of the endoscope.

Another version of the covering is a protective covering adapted for use with a conventional endoscope, the covering including an endoscope drape having a finger access and an endoscope access.

Yet another version of the covering is a protective covering including a sheathed endoscope; a movable sheath for placement over the sheathed endoscope. This version allows the operator to handle the inner sheath without contacting the contaminants thereon.

A preferred embodiment of a sheath is loose and is inherently less expensive than a totally-covered endoscope. First, the operator in the first preferred embodiment only touches the naked endoscope (except for our control handle) and the actuator knobs do not need to be covered at all. Additionally, in all the embodiments presented, the sheath turns inside out as the endoscope is removed from the body. Hence, the inside is contaminated; therefore, the chance of the operator contacting the contaminated material is greatly reduced. Furthermore, the operator's hands never come into contact with bodily fluids in any of the embodiments, so the handle portion of the endoscope does not need to be covered. This loose sheath can be directly attached to a ring or support platen which can be adhered to a patient's body, i.e., the buttocks and can be adhered to the endcap at the other end. The ring, however, does not need to be attached to the endoscope. In this situation, the sheath will turn inside out as the endoscope is removed from the patient. Additionally, the ring adhered to the contaminated sheath can be easily removed from the patient.

Alternatively, the loose sheath can be used in conjunction with a regular, inner sheath lacking its pliable characteristics. First, the loose sheath and the regular inner sheath can be both attached to the endcap at one end while at the other end, the loose sheath alone is attached to the ring via a funnel. In another situation, the two sheaths can be both attached to a funnel part which adheres to a ring. The ring, nevertheless, remains unattached to the endoscope. As in the sole, loose sheath situation, the outer, loose sheath turns inside out. However, the ring closes on itself before removal from the patient.

A drape covering a patient's bowel opening can also utilize this loose sheath. The endoscope can go via a sheath access in the drape itself. Additionally, the drape has a finger access aperture. As in the prior situations, the sheath is everted as the endoscope is removed. When this adhesive drape is removed, it will contain all the contaminated material on the inside.

Finally, another type of loose sheath can be used. This sheath is moveable and can stretch over an end piece at each end. The diameter of the sheath at each end is larger than the main, cylindrical, barrier membrane. These unique features enable the operator to slide back and forth and enable the operator to handle the other sheath which covers the endoscope but allow his hands to remain uncontaminated.

Further advantages, features, and objects of the invention will be apparent from the following detailed description of the invention in conjunction wdth the associated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a first preferred embodiment of the disposable protective covering for shielding an endoscope. The covering is shown before insertion of the endoscope into a patient.

FIG. 2 is a plan view of the end-fitting cap (endcap).

FIG. 3 is a partial cross-section view of the distal portion of the sheath of the present invention showing the attachment of the access tubes from the sheath to the endcap. FIG. 4 is an exploded perspective view of the distal portion of the sheath of the present invention showing the sheath attached to the endcap.

FIG. 5 is a plan view of the disposable protective covering of FIG. 1. The covering is shown during insertion of the endoscope into a patient. FIG. 6 is a cross-sectional view of FIG. 1 at line 6-6. FIG. 7 is a plan view of the protective covering for shielding an endoscope. The covering is shown before insertion of the endoscope into a patient. FIG.8 is a plan view of a second preferred embodiment of the protective covering for shielding an endoscope of FIG. 7. The covering is shown during insertion of the endoscope into a patient.

FIG. 9 is a cross-sectional view of FIG. 7 at line 9-9. FIG. 10 is a plan view of a third preferred embodiment of the protective covering for shielding an endoscope. The covering is shown during insertion of the endoscope into a patient.

FIG.11 is a side view of a fourth preferred embodiment of the protective covering for shielding an endoscope. The covering is shown before insertion of the endoscope into a patient.

FIG. 12 is a side view of the disposable protective covering of FIG. 11. The covering is shown during insertion of the endoscope into a patient.

FIG. 13 is an end view of the protective covering of FIGS. 11-12.

FIG. 14 is a side view of a fifth preferred embodiment of the protective covering for shielding an endoscope. In this embodiment, the covering is movable and is place over a first covering.

DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to any medical instrument having an elongated tubular portion. Specifically, the present invention applies to a variety of endoscopes for examining the body. Such examples include cytoscopes, upper endoscopes for the examination of the esophagus, stomach and duodenum, colonoscopes for examining the colon, angioscopes for examining blood vessels, bronchoscopes for examining the bronchi, laparoscopes for examining the peritoneal cavity, and arthroscopes for examining joint spaces. The present invention is advantageous in that it can be applied to a conventional endoscope having a substantially cylindrical or tubular portion. Depending upon the use of the endoscope, the endoscope tubular portion can vary in length from approximately 1-2 feet, and is designed to enter a body cavity for examination and surgical purposes. Controls at the proximal end, i.e., the manipulating end away from the patient, allow the distal end, i.e., the end entering the patient, to articulate in a variety of directions. In the drawings, a first preferred embodiment of the a sheath for covering a conventional, flexible, basic endoscope in accordance with the invention is illustrated in FIG. 1 at the reference numeral 10. The endoscope 10 includes an operating end or endoscope body portion 12 which permits, by manipulation of the operator, a variety of operations to be performed. The endoscope also includes a distal end 14, illustrated in phantom. The operating end 12 and the distal end 14 are joined by a substantially cylindrical elongated flexible portion 16.

The operating end 12 generally includes an eye piece assembly 18, one or more control knobs 20, an inlet opening 22 through which an instrument such as a forceps is inserted, and air and/or water feed control devices 24, a suction control (not illustrated) and a light inlet 26. The construction of the endoscope 10 is well-known to the art and does not form a part of this invention. Reference is made to Klein U.S. Pat. No. 4,809,678, Opie et al. U.S. Pat. No. 4,825,850, and Opie et al. U.S. Pat. No. 4,852,551 for a variety of descriptions of endoscopes. According to the present invention, one or more relatively loose-fitting, flexible, protective coverings 30 are provided to protect the flexible portion 16 of the endoscope

10 from contamination. The coverings 30 also permit inversion of the covering 30 to capture contaminants on the inside of the covering 30, thereby protecting the operator.

Substantially all of the flexible portion 16 of the endoscope 10 can be covered. Each covering 30 comprises a sheath 36 that includes a main channel for the elongated portion of the endoscope, a proximal end and a distal end. The sheath 36 has a proximal end 32 and a distal end 38. The sheath 36 is flexible, loose fitting over the elongated portion 16 of the endoscope 10, and substantially gas and water impervious to prevent the invasion of contaminants to and from the endoscope 10. The sheath is made of a material that such as an elastomeric material and includes polymeric resinous materials such as natural and synthetic rubbers, thermal plastic polymeric materials such as polyethylene, polypropylene, polyurethane and combinations of natural or synthetic rubbers with thermal plastic polymeric materials such as rubber-modified polyethylene, rubber-modified polystyrene and the like. Referring to the end-fitting cap (endcap) 40 of FIG. 2, located opposite to the proximal end 32 of the sheath 36 is the distal end 38. The distal end 38 includes an endcap 40 having a first distal end 42, a second proximal end 44, and a generally cylindrical wall

46. The first end 42 includes an optically clear element or window 48 of optically clear glass or plastic to serve as a window for the endoscope optics located at the distal end 14 of the flexible portion 16 of the endoscope 10. The window has an internal surface and an external surface. In this manner the protective covering 30, comprising both the sheath

36 and the endcap 40, serves as a protection against contamination while still allowing the endoscope 10 to perform the required task of viewing.

The endcap 40, including the window 48, can be made of a number of materials known to the art. The endcap 40 is preferably constructed of flexible, semi-rigid or rigid plastic or rubber material, to form some structural integrity over the end of the endoscope

10. Preferred examples of materials include styrene, plexiglass and polyvinyl chloride. It is also within the scope of the present invention to provide a window 48 with magnifying capabilities.

It is within the scope of the present invention to provide the window 48 at the first end 42 or along the side wall 46 as required by the purpose of the endoscope. As such, some endoscopes are constructed such that the optical element is a side-viewing optical element.

Reference is now made to FIG. 2 for the preferred embodiment of the endcap

40 of the present invention. The endcap 40 is formed with a substantially cylindrical sidewall 46 open at the proximal end 44 of the endcap 40 to receive the distal end 14 of the flexible portion of the endoscope 10. The distal end 42 of the endcap 40 is bordered by the endcap window 48.

The sidewalls 46 of the endcap 40 are preferably provided with circumferential ridges 49 to insure a tight friction fitting between the sheath 36, the endcap 40 and the connector 52 (shown in FIGS. 1 and 3). The endcap 40 is provided with an endoscope chamber 58, which receives the distal end 14 of the flexible portion 16 of the endoscope 10 as illustrated in FIG. 3.

The endcap 40 is also provided with an access channel 60, a tubular channel extending along the sidewall 46 substantially parallel to the endoscope chamber 58. The distal end 62 of the access channel 60 is peripherally located on the first end 42 of the endcap 40 and includes an extension 64 beyond the first end 42 to an opening 50. The extension 64 provides a number of advantages. First, the extension 64 provides a location for providing a spray port 72 to provide spray cleaning access to the exterior of the window 48. Second, the extension opening 50 provides a manipulating feature for the instrument 66. The extension 64 extends a sufficient distance from the distal end 42 of the endcap to allow the user to observe a surgical tool or instrument, illustrated in FIG. 1 at 66, when the instrument initially exits from the opening 50 of the access channel 60. This extension is important as it will allow the user to accurately manipulate the instrument 66 and protect the patient's body tissue from damage. The extension 64 enables the surgeon to determine exactly when the surgical tool 66 exits the endcap 40. Without this determination the surgeon may have a blind spot, which requires the surgeon to extend the surgical tool 66 from the endcap 40 a substantial distance from the opening 50 before the surgeon is able to see the surgical tool. Without being able to observe the instrument initially extending from the endcap 40, it is possible for the instrument to puncture patient tissue such as a bowel wall before the surgeon can see the instrument.

The second end 44 of the endcap 40 can be sealingly engaged at the distal end 38 of the sheath 36 by a connector 52 (shown in FIGS. 1 and 3), or it may be sealingly engaged with the distal end 38 of the sheath 36 by connectors known to the art, such as glue, tape or other sealants. FIGS. 3-4 illustrate a preferred embodiment of the endcap 40 of the present invention, including at least three access tubes 90A, 90B, 90C and the endoscope chamber 58 to receive the flexible portion 16 of the endoscope 10. The access tubes 90 extend alongside the endoscope's flexible portion 16 rather than through the endoscope as in many prior art instruments. In this manner, the air/water/suction/biopsy tubes in a conventional endoscope are not used and therefore do not become contaminated, which avoids the necessity of cleaning and sterilizing the endoscope 10.

As illustrated in FIGS. 3-4, there are three access tubes 90A, 90B, 90C, each of which provide a required service. In this embodiment, access tubes 90A and 90B are attached to a pump element (not shown) for providing fluids to the patient's body. In the illustrated embodiment, one of the tubes 90A or 90B provides the fluid used to wash the window 48. The other tube is used to deliver fluid such as air to the viewing area. The tubes 90A and 90B are attached at the distal end 38 of the sheath 36 to the second access channel connection ends 80 of the window washer ports 72 to provide fluid flow through to the exit ends 74 of the ports 72. The cleaning fluid is pressurized by means of a pump system (not illustrated) in association with the endoscope 10. Referring now to FIG. 4, the sheath 36 is provided with at least one and preferably more axially directed access tubes 90 extending in axial fashion along inner wall 37 of the sheath 36 from the operating end 12 of the endoscope 10 to the endcap 40. The sheath 36 may be provided with one access tube 90 as shown in FIG. 1, or several tubes 90A, 90B, 90C as shown in FIGS. 3-4. The access tubes 90 have a proximal end 92 and a distal end 94, associated with the distal end 38 of the sheath 36. As shown in FIGS. 5 and 6, the access tubes 90 are separate tubular channels extending axially between the elongated flexible portion 16 of the endoscope 10 and the inner wall 37 of the sheath 36.

The proximal end 92 of the access tubes 90 may be attached or otherwise associated with the endoscope body 10 for ease of use by the surgeon. Otherwise, it can be loose, i.e., not attached to the endoscope as illustrated in FIG. 1. One purpose of the access tubes 90 is to allow passage of a biopsy tool or instrument 66 through the tube 90 to the distal end 62 of the access channel 60 in the endcap 40. In this manner the instrument 66 can be manipulated by a surgeon to perform a surgical task such as a biopsy.

Access tube 90C is generally provided for the dual purpose of manipulating the surgical instrument 66 (illustrated in FIG. 1) and providing suction to withdraw fluid from the viewing area. The instrument 66 is manipulated by the surgeon via access means at the proximal end 92 of access tube 90C. The instrument may be in the form of a forceps, which is inserted into the body for medical treatment. The forceps is manipulated by the surgeon, who can see the end of the forceps via the window 48. The tube 90C is attached near the distal end 38 of the sheath 36 to the first access channel connection end 70 (shown in FIGS. 3-4).

The protective covering 30 of the present invention can be made of relatively inexpensive materials. Thus, it is within the scope of the present invention to provide a disposable protective covering. Once the covering has been used, it can be discarded. However, the access channels in the endoscope do not need to be cleaned as they were not used. The conventional endoscope therefore remains free of contamination.

The first preferred embodiment: Referring to FIG. 1, a sheath 36 contains a ring 96 or other similar support. The ring 96 preferably is several centimeters in diameter. The sheath has a flared end 120 and a non-flared end 122. The flared end 120 is attached to the ring 96. Preferably, the ring 96 has an adhesive on it. The adhesive permits attachment of the ring 96 to the outer surface of a patient, for example, the buttock. As is shown in FIG. 1, before the endoscope 10 is inserted into the sheath 36, the sheath 36 is compressed such as by folding or rolling.

The sheath 36 is attached to the endcap 40, such as by connector 52 as described above. Alternatively, the sheath 36 can be bonded mechanically, chemically or by heat in a manner known to the art, to the endcap 40 so that no leakage can occur across the bond. The sheath 36 is preferably attached to the ring 96 via adhesive backing, but other methods of attachment could also be used with equal success.

As is shown in FIG. 5, after the ring 96 is placed on the outer surface of the patient, distal end 14 of the endoscope 10 is placed against the compressed sheath 36 at the endcap 40. The endoscope 10 is then inserted into the patient, thereby opening the previously compressed sheath 36. The flexibility of the sheath 36 enables it to turn over it and into the patient as illustrated in FIG. 5. The endoscope 10 enters the body cavity as usual to the desired length of the endoscope 10. Thus, when inserted into the patient, the endoscope 10 is covered by the sheath 36. One or more access tube 90 can be inserted between the sheath 36 and endoscope 10 as is shown in FIGS. 1 and 5. A cross- section view of the endoscope 10 covered with the sheath 36 of this embodiment is shown in FIG. 6.

When the procedure is finished, the endoscope 10 is removed from the patient, which pulls the endcap 40. The removal of the endoscope 10 and endcap 40 invert the sheath 36 turning it inside out. When the endoscope 10 is completely outside the patient' s body, the endoscope 10 is removed from the endcap 40, and the ring 96 is removed from the patient. The inversion of the sheath retains all contaminants on the inside the sheath 36.

This embodiment provides a compressed sheath, which is easier to use than conventional sheaths. Conventional sheaths had to be placed on the endoscope before the endoscope was inserted into the patient. This meant that the operator had to handle more of the sheath. It also meant that if the sheathed endoscope touched anything, external contaminants could be transferred to the sheathed endoscope. These contaminants then could be introduced to the patient during the endoscopic procedure. In this embodiment, the sheath is compressed until it is inserted into the patient. This reduces the handling of the sheath by the operator. It also diminishes possible contamination of the sheathed endoscope by external contaminants.

The second preferred embodiment:

The second preferred embodiment is illustrated in FIGS. 7-9. Again, the endoscope uses a compressed first sheath 136 as in the first preferred embodiment.

However, in contrast to the first preferred embodiment, this endoscope utilizes a second sheath 236. The outer, first sheath 136 fits over the inner, second sheath 236. The inner, second sheath 236 has a flared end 226 and a non-flared end 222 to which the endcap 40 is attached. Outer, first sheath 136 has a flared end 220 and a non-flared end 222, also to which the endcap 40 is attached.

The sheathing material of the outer, first sheath 136 has the same barrier characteristics as the sheathing material of the inner, second sheath 236. The endoscope 10 is covered by a double layered sheath 136, 236 but the inner, second sheath 236, however, remains sterile while the endoscope is inside the patient. The ring 96 and the preferred adhesion of the ring 96 to the patient are the same as in the first preferred embodiment.

Referring to FIG. 7, the endoscope is loaded into the sheath as described in the first preferred embodiment. The outer, first sheath 136, as depicted in FIG. 8, is slipped forward and adhered to the patient as in the first preferred embodiment. Only the outer, first sheath 136 becomes contaminated during insertion. A cross-sectional view of FIG.

7 at line 9-9, showing the double-sheathed endoscope is shown in FIG. 9. As the endoscope 10 is withdrawn from the body, the outer, first sheath 136 is turned inside out, thereby containing the contaminated inner, second sheath 236. Then, the ring 96 of the outer, first sheath 136 closes over on itself, thereby sealing the contaminated inner, second sheath 236 inside the outer, first sheath 136. This second preferred embodiment also prevents contamination of the endoscope by the patient. The outer, first sheath 136, which seals over the contaminated inner, second sheath 236 also greatly reduces the chance of the operator being contaminated.

The third preferred embodiment: The third preferred embodiment is illustrated in FIG. 10. This embodiment, like the second preferred embodiment, has two sheaths, an inner sheath 336 and an outer sheath 436, which preferably is a compressed sheath as in the two previous preferred embodiments. In the third embodiment, the outer sheath 436 has a flared end 320 that is attached to the ring 96 and a non-flared end 322. The inner sheath 336 has a non-flared end 324 that is attached to the endcap 40 and a flared end 326, which is attached to the non-flared end 322 of the outer sheath 436. Again, both sheaths 336 and 436, are made of sheathing material having the same barrier properties.

In use, the tube 90 and the endoscope 10 are inserted into the second, flared end 326 of the inner sheath 336. The outer sheath 436 is adhered to the patient at the ring 96. The endoscope 10 is inserted into the patient in the usual manner. As the endoscope 10 is removed from the body , the ring portion 96 becomes unattached from the patient and adhered to itself. This results in the containment of any potential contamination within the interior of sheath 436.

The fourth preferred embodiment:

The fourth preferred embodiment is a drape 200 illustrated in FIGS. 11-13. The specialized drape 200 can vary in shape. It is designed to cover the bowel opening and preferably seals it with an adhesive barrier. The finger access 202 and the endoscope access 204 preferably are built into the drape 200 itself. Alternatively, the endoscope access 204 and the finger access 202 are initially separate pieces attached to the larger barrier drape 200. The tubing 90 can be asserted into endoscope access 204. In use, the finger cover 202 is everted and a rectal exam is done as is usual in this procedure. When the rectal exam is done, the endoscope is inserted into the everted sheath 204 and then inserted into the patient. When the exam is finished, the endoscope 10 everts the sheathing 204 as in FIG. 12, and the drape 200 is removed from the patient and closed over on itself keeping all the contaminated surfaces on the inside of the drape

200.

The fifth preferred embodiment:

FIG. 14 depicts a movable sheath 536 that encloses a unsheathed or sheathed endoscope 10 as described in the previous embodiments. The moveable sheath 536 has a first end piece 128 and a second end piece 130. The diameter of both end pieces 128, 130 preferably are larger than the diameter of the mid-section of the moveable sheath 536. The endoscope 10 is inserted through the first end piece 128 and is fed through the moveable sheath 536 to its second end piece 130. The moveable sheath 536 slides back and forth over the endoscope 10 allowing the operator to handle the other endoscope 10 without contacting contaminants on the endoscope 10. The moveable sheath 536 is particularly useful for inserting and removing the endoscope into and out of the patient.

The invention is not intended to be limited to the preferred embodiments described above, but rather is intended to be limited only by the claims set out below. Thus, the invention encompasses all alternate embodiments that fall literally or equivalently within the endoscope of these claims. It is understood that in the claims, means plus function clauses are intended to encompass the structures described above as performing their recited function, and also both structural equivalents and equivalent structures. As an example, though a nail and a screw may not be structural equivalents insofar as a nail employs a cylindrical surface to secure parts together whereas a screw employs a helical surface, in the context of fastening parts, a nail and a screw are equivalent structures.

Claims

CLAIMSWhat is claimed is:

1. A protective covering adapted for use with a conventional endoscope having a proximal and a distal end, the covering comprising:

(a) a first elongated hollow sheath having a first end and a second end and having a wall of flexible substantially impervious material between the first and second ends;

(b) an endcap located at the first end for receiving the distal end of the endoscope, and

(c) a body-attachment ring located at the second end, the ring comprising means to for placement on a body part of a patient

2. The protective covering of claim 1 wherein the first sheath is compressed prior to placement on the endoscope.

3. The protective covering of claim 1, further comprising an adhesive disposed on the ring, wherein the adhesive permits attachment of the ring to the patient.

4. The protective covering of claim 1, wherein the wall of flexible material is flared at the second end for attachment of the the ring.

5. The protective covering of claim 1, wherein the end cap comprises a utility opening for the access channel.

6. The protective covering of claim 1, further comprising an access tube.

7. The protective covering of claim 2, wherein the first sheath is compressed by rolling the first sheath.

8. The protective covering of claim 2, wherein the first sheath is compressed by folding the first sheath.

9. The protective covering of claim 1 , further comprising a second elongated hollow sheath having a first end and a second end and having a wall of flexible material between the first and second ends, wherein the first and second sheaths are adhered to the endcap.

10. The protective covering of claim 1, further comprising a second elongated hollow sheath having a first end and a second end, wherein one of the first and second ends are flared, and wherein the second sheath has a wall of flexible material between the first and second ends; wherein the first sheath is further attached to the second sheath at the flared end and the second sheath adhered to the endcap.

11. A protective covering adapted for use with a conventional endoscope, the covering comprising a drape having a finger access and an endoscope access.

12. A protective covering adapted for use with a conventional endoscope, the covering comprising a sheathed endoscope; a movable sheath for placement over the sheathed endoscope.