WO2016209240A1

WO2016209240A1 - Expandable fitting for a medical scoping device

Info

Publication number: WO2016209240A1
Application number: PCT/US2015/037737
Authority: WO
Inventors: John Schreiner; Travis Henry Bendele; Anoopam NATH; David Nitsan
Original assignee: Medivators Inc.
Priority date: 2015-06-25
Filing date: 2015-06-25
Publication date: 2016-12-29

Abstract

Provided is a fitting for a medical scoping device, the fitting comprising a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive the medical scoping device along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance. Methods of making and methods of use are also disclosed.

Description

EXPANDABLE FITTING FOR A MEDICAL SCOPING DEVICE

BACKGROUND

[0001] Endoscopes play a critical role in medical diagnosis and treatment. Often, endoscopes can be used to illuminate, examine and document difficult-to-access areas and other body regions to facilitate diagnosis and treatment of hidden diseases. Endoscopes can also assist in enhancing the planning and preparation of invasive operations. Endoscopes include cameras to allow for real-time visualization of inner biological lumens, such as that of the esophagus, the stomach, the duodenum, the small intestine, the colon, and the entire length of the large intestine with various types of endoscopes.

[0002] There are various types of endoscopic procedures. For example, enteroscopy is the endoscopic examination of the small intestine. Colonoscopy is the endoscopic examination of the colon and the distal part of the small bowel. Flexible sigmoidoscopy is the examination of the rectum and lower part of the bowel. These forms of endoscopy allow for visual diagnosis of the digestive tract and aid in biopsy or removal of suspected lesions. Although endoscopic examinations are effective techniques for assessing the state of health of the bowel, they are inconvenient, uncomfortable, expensive and are associated with potential complications.

[0003] The inner lumen of the colon is composed of folds and undulations. As the endoscope is advanced into the lumen, the folds can hamper the medical practitioner's ability to visualize the entire surface of the mucosa and in particular, detect pre-malignant and malignant lesions tucked between the folds during extubation. Furthermore, the position of the tip of the endoscope may be difficult to maintain from the moment at which a lesion or polyp is detected to the completion of any therapeutic procedure. While a medical practitioner advances or retracts the endoscope, the geometry of the lumen and the folds may cause the tip of the endoscope to jerk and slip, particularly when traversing a bend of the colon or other biological lumen. Should the endoscope slip backwards, the medical practitioner will lose his or her position, and may struggle to find it once again. This is particularly important when a lesion, a cancer or a polyp is identified, as the medical practitioner now has to reposition the endoscope to find it again.

[0004] Therefore, there is a need for a fitting (e.g., cover, cap, etc.) for a medical scoping device (e.g., endoscope) that reduces the risk of complications during a procedure. A medical scoping device fitting which allows for improved visualization of a biological lumen (e.g., colon, small bowel, etc.) would be beneficial. It would also be beneficial to provide a medical scoping device fitting that expands the aforementioned folds of the biological lumen to improve visibility of the lining of the biological lumen. Moreover, it would be beneficial to provide a disposable medical scoping device fitting that is compressible to allow access into narrower portions of a biological lumen and debris from the lumen to pass by the fitting.

SUMMARY

[0005] In some embodiments, a fitting for a medical scoping device is provided that reduces the risk of complications during a procedure. A medical scoping device fitting is provided, which allows for improved visualization of a biological lumen (e.g., colon, small bowel, etc.). In some embodiments, there is a medical scoping device fitting that expands the folds of the biological lumen to improve visibility of the lining of the biological lumen. In some embodiments, there is a disposable medical scoping device fitting that is compressible to allow access into narrower portions of a biological lumen and debris from the lumen to pass by the fitting.

[0006] In one embodiment, there is a fitting for a medical scoping device, the fitting comprising a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive the medical scoping device along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance.

[0007] In another embodiment, there is a fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an interior having an opening to receive an endoscope along the longitudinal axis, the body having a first cylindrical portion and a second cylindrical portion separable from the first cylindrical portion, the first cylindrical portion comprising protuberances being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the first cylindrical portion, the second cylindrical portion comprising protuberances being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the second cylindrical portion, each of the protuberances having an inner end and an outer edge to engage tissue, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance.

[0008] In one exemplary embodiment, there is a method of performing an endoscopy, the method comprising disposing an endoscope cap on a distal end of an endoscope, the cap comprising a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive the endoscope along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the endoscope, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance; and inserting the distal end of the endoscope into a biological lumen to move the protuberances radially inward relative to the body of the cap; and moving the endoscope proximally in the biological lumen for a distance to move the protuberances radially outward relative to the body of the cap.

[0009] In another exemplary embodiment, there is a kit for performing an endoscopy, the kit comprising a disposable endoscope cap, the cap having a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive an endoscope along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the cap, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance; and a sterilized packaging configured to provide an airtight seal for the cap.

[0010] In yet another embodiment, there is a fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein the middle portion comprises a recess that increases flexibility of the outer edge relative to the inner end of each protuberance. [0011] In one embodiment, there is a fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein (i) the inner end of each protuberance has the same or increased width or surface area relative to the outer edge of each protuberance and the middle portion has a decreased width or surface area relative to the width of the inner end or outer edge of the protuberance; (ii) the inner end of each protuberance has a reinforced region having increased thickness relative to the thickness of the middle portion and the outer edge of the protuberance; or (iii) the inner end of each protuberance has decreased width or surface area relative to the outer edge of each protuberance.

[0012] In another embodiment, there is a fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and radially or circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein the outer edge of each protuberance comprises a raised surface configured to engage tissue, wherein said engagement causes a change in shape of the fitting.

[0013] Additional features and advantages of various embodiments will be set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practice of various embodiments. The objectives and other advantages of various embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In part, other aspects, features, benefits and advantages of the embodiments will be apparent with regard to the following description, appended claims and accompanying drawings where: [0015] FIG. 1 illustrates a perspective view of an embodiment of a medical scoping device fitting (e.g., endoscope) in accordance with the principles of the present disclosure. The fitting illustrated includes two rows of protuberances having central windows and recesses or notches to allow for greater flexibility of the outer edge of the protuberances;

[0016] FIG. 2 illustrates a side view of the fitting shown in FIG. 1;

[0017] FIG. 3 illustrates a side cross- sectional view of another embodiment of a fitting, where the protuberances are contoured at the outer edges to reduce tissue damage and the outer edges of the protuberances in the first row have a decreased surface area relative to the protuberances in the second row;

[0018] FIG. 4 illustrates a side cross-sectional view of another embodiment of a fitting wherein the protuberances include a reinforced portion in the inner end;

[0019] FIG. 4A illustrates a side view of the fitting shown in FIG. 4 wherein the protuberances are being flexed outward, which often occurs when the medical scoping device tip is moved proximally out of the biological lumen;

[0020] FIG. 4B illustrates a magnified side view of the fitting shown in FIG. 4 wherein the protuberances have an outer edge and an incline adjacent the outer edge, which reduces damage to tissue and allows additional flexibility at the outer edge;

[0021] FIG. 4C illustrates a side view of the fitting shown in FIG. 3 wherein the protuberances are being flexed outward, which often occurs when the medical scoping device tip is moved proximally out of the biological lumen;

[0022] FIG. 5 illustrates a top view of another embodiment of the fitting having longer and thinner protuberances;

[0023] FIG. 6 illustrates a perspective view of an embodiment of a medical scoping device fitting shown in FIG. 5 in accordance with the principles of the present disclosure. The fitting illustrated includes two rows of protuberances having central windows and thinned outer portions to customize or vary flexibility;

[0024] FIG. 7 illustrates a side view of the fitting shown in FIG. 5, the protuberances are in the resting position;

[0025] FIG. 8 illustrates a top view of the fitting shown in FIG. 5;

[0026] FIG. 9 illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated is monolithic and includes two rows of protuberances having central windows, the outer edge of the fitting having a reduced surface area relative to the inner edge of the protuberance;

[0027] FIG. 10 illustrates a side view of the fitting shown in FIG. 9;

[0028] FIG. 11 illustrates a bottom view of the fitting shown in FIG. 9. The fitting illustrated includes an overmolded portion to facilitate proper positioning on an endoscope, the protuberances are shown circumferentially arrayed outwardly from the body;

[0029] FIG. 12 illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated includes two rows of protuberances having wide inner ends having increased surface area and width when compared to the reduced surface area and width of the outer edge of the protuberances;

[0030] FIG. 13 illustrates a side view of the fitting shown in FIG. 12, the notches or recesses shown in this view increase flexibility of the outer edges of the protuberances;

[0031] FIG. 14 illustrates a top view of the fitting shown in FIG. 12;

[0032] FIG. 15 illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated includes two rows of protuberances having wide inner ends, narrow middle portions, and flared outer ends;

[0033] FIG. 16 illustrates a side view of the fitting shown in FIG. 15, the notches or recesses shown in this view increase flexibility of the outer edges of the protuberances;

[0034] FIG. 17A illustrates a top view of the fitting shown in FIG. 15;

[0035] FIG. 17B illustrates a bottom view of the fitting shown in FIG. 15, the notches or recesses shown in this view increase flexibility of the outer edges of the protuberances and the protuberances span slightly less than 360 degrees around the body of the fitting;

[0036] FIG. 18 illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated includes two rows of protuberances having linearly widening profiles;

[0037] FIG. 19 illustrates a side view of the fitting shown in FIG. 18. The fitting illustrated includes two rows of protuberances having wide outer edges having increased surface area and width when compared to the reduced surface area and width of the inner end of the protuberances, the notches or recesses shown in this view increase flexibility of the outer edges of the protuberances; [0038] FIG. 20 illustrates a top view of the fitting shown in FIG. 18 the protuberances span slightly less than 360 degrees around the body of the fitting;

[0039] FIG. 21 illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated includes a row of protuberances as well as a transparent or semi-transparent extension member;

[0040] FIG. 22 illustrates a side view of the fitting shown in FIG. 21;

[0041] FIG. 23 illustrates a top view of the fitting shown in FIG. 21;

[0042] FIG. 24 illustrates a side view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The protuberances of the fitting comprise a plurality of raised surfaces at the outer edges to aid in frictional force to move the folds of the biological lumen;

[0043] FIG. 24A illustrates a perspective view of the fitting shown in FIG. 24 attached to the distal end of a medical scoping device. The fitting includes compressible members which are in a low profile configuration to allow passage through a biological lumen;

[0044] FIG. 24B illustrates a perspective view of the fitting shown in FIG. 24 attached to the distal end of a medical scoping device. The fitting includes compressible members which are in an expanded configuration to increase the inner diameter of a biological lumen;

[0045] FIG. 25 illustrates a bottom view of the fitting shown in FIG. 24;

[0046] FIG. 26 illustrates a top view of the fitting shown in FIG. 24;

[0047] FIG. 27 illustrates a schematic anatomical section of a medical scoping device fitting of the present application in the course of a medical scoping procedure. FIG. 27 shows insertion of the scoping device into the colon of an individual undergoing an endoscopic procedure. The protuberances of the fitting move radially inward as the fitting enters the colon and the protuberances are compressed by the colon wall;

[0048] FIG. 28 illustrates a schematic anatomical section of a medical scoping device fitting of the present application shown in FIG. 27 in the course of a medical scoping procedure, where the protuberance moves radially outward as the medical scoping device is withdrawn from the colon and protuberances unfold the colon lining to improve visualization of the colon lining, alternatively this can be accomplished by air suction causing the colon wall to collapse or wrap around the fitting; [0049] FIG. 29 A illustrates a perspective view of an embodiment of a medical scoping device fitting in accordance with the principles of the present disclosure. The fitting illustrated is a two component system, where two rows of protuberances are present and the fitting can be simply assembled;

[0050] FIG. 29B illustrates a perspective view of a partially assembled medical scoping device fitting shown in FIG. 29A; and

[0051] FIG. 29C illustrates a perspective view of an assembled medical scoping device fitting shown in FIG. 29A.

[0052] Like reference numerals indicate similar parts throughout the figures. It is to be understood that the figures are not drawn to scale. Further, the relation between objects in a figure may not be to scale, and may in fact have a reverse relationship as to size. The figures are intended to bring understanding and clarity to the structure of each object shown, and thus, some features may be exaggerated in order to illustrate a specific feature of a structure.

DETAILED DESCRIPTION

[0053] In some embodiments, a fitting for a medical scoping device is provided that reduces the risk of complications during a procedure. A medical scoping device fitting is provided, which allows for improved visualization of a biological lumen (e.g., colon, small bowel, etc.). In some embodiments, there is a medical scoping device fitting that expands the folds of the biological lumen to improve visibility of the lining of the biological lumen. In some embodiments, there is a disposable medical scoping device fitting that is compressible to allow access into narrower portions of a biological lumen and debris from the lumen to pass by the fitting.

[0054] The fitting comprises a plurality of protuberances that are configured to project outwardly or inwardly relative to the body. Protuberances or projections include, for example, fingers, wings, bristles, spikes, spines, fins, wedges, paddles, cones or the like that have flexibility characteristics to contact and unfold the biological lumen. The protuberances or projections (e.g., fingers, wings, bristles, spikes, spines, fins, wedges, paddles, cones, etc.) place an expansion force against the walls of a biological lumen to straighten the folds present in the wall of the lumen. The flexibility of the protuberances allows the fitting to provide adequate expansion forces to variously sized portions of the biological lumen without damaging tissue. In this way, the methods and devices of the present disclosure are used to increase visualization of the biological lumen (e.g., colon, esophagus, etc.) during a medical scoping procedure (e.g., colonoscopy or endoscopy). The protuberances of the current application are configured to expand (e.g., move outward) from the body of the fitting and unfold to contact the biological lumen (e.g., colon) as the fitting disposed on the medical scoping device is moved proximally in the biological lumen. This is so as the protuberances encounter resistance and friction from the lumen tissue as the fitting is moved proximally in the lumen. The protuberances contact the folds in the lumen and allow the folds to open so that visualization of the lumen is easier.

[0055] It will be understood that a fitting includes a cap or covering for a medical scoping device.

[0056] The protuberances of the current application are configured to fold, flatten, or move inward relative to the body of the fitting as the medical scoping device is moved distally in the biological lumen.

[0057] In some embodiments, the fitting is configured such that the protuberances comprise a gradient moment of flexibility from one end of the protuberance to the other. That is, the protuberances are configured to have a varied degree of flexibility along its length. In some embodiments, the change in flexibility is gradual.

[0058] In some embodiments, the protuberances have regions of high flexibility directly adjacent to regions of lower flexibility. In some embodiments, the variability in flexibility is customized or varied by the thickness of the protuberances. The flexibility of the protuberances can be increased or decrease by, among other things, increasing or decreasing the thickness of discrete regions of the protuberance to create one or more pivot points on the protuberance, disposing different notches or recesses at discrete regions of the protuberance, increasing or decreasing the width or surface area at discrete regions of the protuberance, increasing or decreasing windows or cutouts at discrete regions of the protuberance, and/or controlling the elasticity at discrete regions of the protuberance. In some embodiments, controlling contact points and friction with the lumen wall can be accomplished by increasing or decreasing the angles of the protuberances, having different contours of the edges of the protuberances, and/or having different raised surfaces or inclines on or in the protuberances.

[0059] These embodiments may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. Also, in some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "top" and "bottom" are relative and used only in the context to the other, and are not necessarily "upper" and "lower".

Fitting

[0060] The following discussion includes a description of a fitting for a medical scoping device in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures.

[0061] The components of device discussed herein can be fabricated from biologically acceptable materials suitable for medical applications, including synthetic polymers. For example, the components of the device, individually or collectively, can be fabricated from materials such as machined or injection molded thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS04 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, polyphenylene, polychloropene, polyamide, polyetherimide, polyethylene, epoxy, partially resorbable materials, totally resorbable materials, polyglycolide, polytyrosine carbonate, polycaprolactone or any combination thereof.

[0062] The components of the device, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of device 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. It is preferred that the devices as described herein are constructed of a suitable biocompatible material to impart various desirable characteristics, such as flexibility, resilience, and deformability.

[0063] The components of the device disclosed herein may be coated with a lubricant to facilitate insertion of the fitting into a biological lumen and advancement through said lumen. Suitable lubricants include, but are not limited to, hydrogel polymers such as poly(2- hydroxyethyl methacrylate) (PHEMA) and ComfortCoat®, suitable hydrophobic agents include, but are not limited to, silicone, glycerine, olive oil, castor oil, chlorotrifluoroethylene (CTFE oil) and polyphenyl ethers or a mixture thereof. The lubricant may be sprayed or brushed onto the outer surface of the disclosed devices. In some embodiments, the lubricant is coated only onto the distal end of the device so that only the outer surface of distal end of the fitting is coated with the lubricant.

[0064] In some embodiments, the fitting may have a modulus of elasticity in the range of about 1 x 10² to about 6 x 10⁵ dyn/cm², or 2 x 10⁴ to about 5 x 10⁵ dyn/cm², or 5 x 10⁴ to about 5 x 10⁵ dyn/cm 2 or about 1 x 102 to about 6 x 105 dynes/cm 2 , or 2 x 104 to about 5 x 105 dynes/cm 2 , or 5 x 10 4 to about 5 x 105 dynes/cm 2.

[0065] As used herein, the term "medical scoping device" refers to any or all of endoscopes, enteroscopes, sigmoidoscopes, gastroscopes, colonoscopes and panendoscopes, or other suitable devices for insertion into a biological lumen and visualization therein. Medical scoping device is used interchangeably and is intended to include all scoping instruments whether passed directly or through a cannula into a body/organ/tissue cavity. Endoscopy involves the inspection of the inside of the body or body cavity and includes arthroscopy, cystoscopy, gastroscopy, uteroscopy and colonoscopy whereas enteroscopy is the examination of the small intestine including the duodenum, jejunum, and ileum. In all instances the scopes are elongate flexible probes and it is intended that the covers of the present invention may be used in conjunction with all of the aforementioned scopes. [0066] In some embodiments, the components of the devices disclosed herein are disposable. Thus, fitting 10 is configured to be discarded following use. Further, the devices set forth herein may be made of a low cost, disposable material so that labor and cost associated with cleaning and autoclaving is avoided.

[0067] Accordingly an "endoscopic procedure" is intended to include any medical procedure or examination that involves use of an endoscope as hereinbefore described.

[0068] As disclosed herein, the distal end of fitting 10 is commensurate with the distal end of an endoscope shaft which comprises lenses, or channels, such as air suction, conduits, biopsy channels, and light guides. The distal end of the endoscope is furthest from the medical practitioner and as such is the end of the endoscope which is deepest within the patient's biological lumen. Thus, the distal end comes into contact with folds of the lining and looped segments of the biological lumen. Accordingly, distal movement of the endoscope is a forward movement into a patient's bowel. Conversely, the proximal end of the endoscope is the end situated nearest the operator. Thus, proximal movement of the endoscope is a backward movement towards the operator. The endoscope is moved distally during intubation and moved proximally during extubation, where the fitting then contacts the folds of the biological lumen.

[0069] Turning now to FIGS. 1-5, there are illustrated components of a fitting 10 for an endoscope. In some embodiments, fitting 10 is a cap or covering configured to be placed at the distal end of the endoscope. As shown in FIG. 1, fitting 10 extends along longitudinal axis L between a distal end 12 and a proximal end 14. Fitting 10 includes a central channel 16 extending coaxially along the longitudinal axis L. Channel 16 is configured to receive and engage a sidewall of an endoscope. An inner wall of channel 16 includes a plurality of ribs 18 to increase a friction fit between fitting 10 and the sidewall of an endoscope. Ribs 18 extend along the longitudinal axis to prevent unintended rotational movement of fitting 10 relative to the endoscope. In some embodiments, fitting 10 is made from an elastomeric material to facilitate stretching to engage with a variety of endoscopes having varying diameters. In some embodiments, fitting 10 is configured to engage the distal tip of an endoscope. In some embodiments, fitting 10 is configured to engage the distal end of an endoscope adjacent to the distal tip. For example, fitting 10 may be positioned around the distal end of an endoscope, but spaced 1 mm to about 30 mm from the distal tip of the endoscope. [0070] Fitting 10 includes a first region, such as, for example, a first cylindrical member 20 and a second region, such as, for example, a second cylindrical member 30. Cylindrical member 20 includes at least one flexible wing, such as, for example, a protuberance 22. As shown in FIGS. 1-5, cylindrical member 20 includes four protuberances 22. In some embodiments, however, cylindrical member 20 may have more or less than four protuberances 22. For example, cylindrical member 20 may have one, two, three, five, six, seven, eight, nine, ten or more protuberances 22. Protuberances 22 are arranged in a row and extend outward from cylindrical member 20 between an inner end and an outer edge. Protuberances 22 are each evenly spaced apart from one another and radially arranged about an outer surface of cylindrical member 20. As shown in FIG. 1, protuberances 22 include a wide inner end that tapers to an outer edge that is narrower relative to the inner end. This configuration provides stability to protuberances 22 by adding support to the base of the protuberances 22.

[0071] Similarly to cylindrical member 20, cylindrical member 30 includes at least one flexible wing, such as protuberance 32. As shown in the figures, cylindrical member 30 comprises four protuberances 32. In some embodiments, however, cylindrical member 20 may have more or less than four protuberances 22. For example, cylindrical member 20 may have one, two, three, five, six, seven, eight, nine, ten or more protuberances 22. Similar to protuberances 22, protuberances 32 are arranged in a row and each extend outward from cylindrical member 30 between an inner end and an outer edge. Additionally, protuberances 22 are each evenly spaced apart from one another and radially arranged about an outer surface of cylindrical member 20. Member 20 is oriented relative to member 30 such that protuberances 22 are offset from protuberances 32.

[0072] In some embodiments, member 20 is separable from member 30, as shown for example in FIG. 3. Member 30 includes a circumferential recess configured to receive member 20. Member 20 includes an inner diameter complementary to the outer diameter defined by the recess to facilitate a friction fit between members 20, 30. In some embodiments, as shown in FIG. 4, member 30 includes at least one locking member 38 configured to engage a complementary groove in member 20. Locking member 38 is configured to limit or prevent rotation of member 20 relative to member 30. As shown in FIG. 3, member 30 may include a flared proximal end of channel 16 to facilitate insertion of an endoscope. Member 30 also includes a lip at distal end 12 to engage with the tip of an endoscope. Thus, the lip provides a stopping mechanism to ensure that fitting 10 engages the endoscope through the entirety of channel 16, and also ensures that fitting 10 does not slide beyond the distal tip of the endoscope.

[0073] In some embodiments, member 20 includes an amount of protuberances that varies from that of member 30. For example, in some embodiments, member 20 may include one less protuberance than member 30 to facilitate insertion and distal advancement of an endoscope into a biological lumen. In various embodiments, the separability of member 20 from member 30 allows for mixing and matching of variously configured protuberances 22, 32 according to the needs of an endoscopic procedure.

[0074] In some embodiments, there may be additional circumferential members configured to engage with member 30. For example, member 30 may include an additional circumferential recess to receive an additional cylindrical member having a row of protuberances. Additionally, in some embodiments, members 20, 30 may include more than just a single row of protuberances. For example, members 20, 30 may include two, three, four, five, six, seven, eight, nine or ten rows of protuberances. The rows on members 20, 30 may be arranged such that the protuberances of neighboring rows are staggered with respect to one another. Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another. Members 20, 30 may be elongated to accommodate multiple rows of protuberances to allow the protuberances a full range of flexible motion without interfering with neighboring protuberances.

[0075] As shown in FIGS. 1-5, protuberances 22, 32 include central windows 24, 34 which extend from the inner end 200 toward the outer edge 202 of the protuberances. The protuberances project out from the body 204. Protuberances can be spaced apart from each other by arc 206. Windows 24, 34 allow for added flexibility of protuberances 22, 32 when being advanced or withdrawn through a biological lumen. The windows or cutouts run in a longitudinal axis along the protuberance and also provide a degree of firmness that assists in unfolding the biological lumen folds as the fitting 10 is moved proximally in the lumen. Additionally, the presence of windows 24, 34 allows the protuberances to bend from side to side, which enables a medical practitioner to turn, withdraw or move forward an endoscope within the biological lumen without potentially damaging tissue. Furthermore, in some embodiments, protuberances 22, 32 may include notches, such as, for example recesses or notches 26, 36. Recesses or notches 26, 36 provide an easily flexible point along the length of the protuberances 26, 36 which are configured to flex prior to flexure of the rest of the protuberance. Recesses or notches 26, 36 provide the desired flexibility as the thickness in these areas is reduced to provide the pivot points. In some embodiments, they are disposed in the middle portion 208 of the protuberance and provide pivot points so that the outer edges of the protuberance can be bent from side to side, which enables a medical practitioner to turn, withdraw or move forward an endoscope within the biological lumen without potentially damaging tissue. It will be understood by those of ordinary skill in the art that although one recess or notch is shown on each protuberance, two, three, four, five, six or more recesses or notches can be on one protuberance to have the desired flexibility.

[0076] In FIG. 1, there is a lower rim 214 to support the second row of protuberances that surround the body and there is upper rim 210 to support the first row of protuberances. The distal end 12 of the fitting is smooth (there are no recesses or projections) as for ease of insertion into a biological lumen. Likewise, sidewall 212 is also smooth (there are no recesses or projections) as for ease of insertion into a biological lumen. The medical scoping device will be covered or capped by fitting 10. The medical scoping device will have the fitting placed on it along the fittings longitudinal axis shown as L. The fitting will not impair the view of the medical scoping device. Outer edge 202 is shown with a reduced width and surface area as compared to inner end 200. In some embodiments, outer edge 202 can be contoured or be free of sharp edges or points so as to prevent damage to the interior of the biological lumen.

[0077] FIG. 2 illustrates a side view of the fitting shown in FIG. 1. The fitting is shown where the protuberances are moved circumferentially inward, where the angle AA from the top of the longitudinal axis of the fitting to the top of the protuberance is from about 100 degrees to about 150 degrees and the angle BB from the bottom of the protuberance to the bottom of the fitting is from about 30 degrees to about 80 degrees.

[0078] In some embodiments, the protuberances are positioned at an angle AA from the top of the longitudinal axis of the fitting to the top of the protuberance of from about 100° to 115°, 120° to 130°, 135° to 140° or 145° to about 160°. In some embodiments, the protuberances are positioned at an angle BB from the bottom of the protuberance to the bottom of the longitudinal axis of the fitting from about 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, to about 80°. These angles can vary as the protuberances are at their rest position, their circumferentially inward position, and in their circumferentially outward position. [0079] In some embodiments, as shown in FIGS. 4-4B, protuberances 22, 32 may include variable thicknesses along their lengths to affect the flexibility of the protuberances. For example, as shown in FIGS. 4 and 4A, each protuberance 22 includes a reinforced portion 28, and each protuberance 32 includes a similar reinforced portion 38. The reinforced portion 28, 38 comprises a buttress at the root of the protuberance which increases mechanical stability and reduces flexibility of the inner end 200 of the protuberance. In some embodiments, the reinforced region has a peak von Mises stress or tensile stress of from about 3.2 xlO to about 9.8 x 10 3 psi or 5.2 xl03^J to about 9.5 x 103^J psi or 7.2 x 103 to about 8.868 x 103 psi. The reinforced region 28, 38, in the embodiment shown, can be a region that has increased thickness relative to the middle portion or outer edge of the protuberance.

[0080] In some embodiments, as shown in FIG. 4C, protuberances 151, 155 include uniform thicknesses along their bodies along their lengths to allow for greater flexibility at all points along the lengths of the protuberances. Protuberances 151 are disposed with a first region of the fitting and protuberances 155 are disposed in a second region of the fitting. Protuberances 151 include an inner end 153, and protuberances 155 include an inner end 157. Inner ends 153, 157 extend from the exterior body of the fitting and include a thickness that is uniform across the entire length of the protuberances 151, 155. Unlike protuberances 22, 32, protuberances 151, 155 do not include any reinforced portion. Thus, protuberances 151, 155 are configured to be uniformly flexible along the entire length or substantially the entirely length of protuberances 151, 155. In some embodiments, inner ends 153, 157 have a peak von Mises stress or tensile stress of from about 1.0 xlO³ to about 2.0 x 10⁴ psi or 1.3 xlO³ to about 1.8 x 10⁴ psi or 1.0 xlO⁴ to about 1.7 x 10⁴ psi.

[0081] In some embodiments, the outer edges 202 of the protuberances also include an increased thickness to prevent the tip from bending. In various embodiments, it is desirable that the outer edge of the protuberances be resistant to flexing to provide a flat grip from which to provide a friction contacting surface with the lining of a biological lumen, as discussed herein. As shown in FIG. 4, when protuberances 22, 32 are moved to a radially outward position or unfolded position, as discussed herein, flexibility is focused at the portion between the inner end and the outer edge. In some embodiments, one or more protuberances include a sloped or inclined portion 37 adjacent window 34, as shown in FIG. 4B. Sloped or inclined portion extends from a bottom surface to a top surface of the protuberance at an angle relative to the surfaces. Sloped portion or inclined portion 37 is configured to allow a greater surface area for gripping the lining of a biological lumen, while also allowing for greater flexibility than at the thicker outer edge 202 of the protuberance. In some embodiments, only protuberances 32 include a sloped portion or inclined portion 37. In some embodiments, both protuberances 22 and protuberances 32 include sloped or inclined portions 37.

[0082] In some embodiments, the protuberances are between about 2 to about 20 mm in length from the inner end to the outer tip. In some embodiments, the protuberances can have a length between about 4 to about 18 mm, between about 7 to about 16 or between about 10 to about 15 mm. In various embodiments, each of the protuberances can be from about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, to about 20 mm in length.

[0083] In various embodiments, each of the protuberances has a width of from about 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm, 3.25 mm, 3.5 mm, 3.75 mm, 4 mm, 4.25 mm, 4.5 mm, 4.75 mm, to about 5 mm in width. The width can vary throughout the fitting and/or along the protuberance to achieve the desired flexibility.

[0084] In various embodiments, the fitting, body, protuberances can have a thickness ranging from about 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm, 3.25 mm, 3.5 mm, 3.75 mm, 4 mm, 4.25 mm, 4.5 mm, 4.75 mm, to about 5 mm in width. The thickness can vary throughout the fitting, body and/or along the protuberance to achieve the desired flexibility. For example, at the inner edge of the protuberance the thickness can be about 1 mm to about 1.5 mm, then in the middle portion, the thickness can be about 0.5 mm by the recess or notch, then by the outer edge the thickness can be about 0.75 mm to provide the desired flexibility to the protuberance.

[0085] In various embodiments, rows of protuberances or individual protuberances may be variously sized. For example, the row of protuberances 32 may be longer than the row of protuberances 22. In some embodiments, protuberances 32 include a length of about 14 mm, and protuberances 22 include a length of about 11 mm. As shown in FIGS. 1-5 the width of the protuberances tapers from the inner end to the outer edge. The taper may be varied according to the needs of a specific endoscopic procedure. In some embodiments, the protuberances have a width of about 5 mm to about 20 mm toward the inner end and a width of about 1 mm to about 10 mm at the outer edge. In some embodiments, protuberances 32 are wider than protuberances 22. For example, in some embodiments, protuberances 32 have a width of about 11 mm at the inner end and a width of about 6 mm at the outer edge.

[0086] In some embodiments, the thickness of each of the protuberances 22, 32 is varied along the length of the protuberances. For example, in some embodiments, as shown in FIGS. 1-5, each of the protuberances includes areas of a first degree of flexibility at the inner end and at the outer edge and an area of a second degree of flexibility in a middle portion between the inner end and the outer edge, the second degree of flexibility being greater than the first degree of flexibility. For example, each protuberance may have a thickness between about 2 mm to about 8 mm at the inner end. In some embodiments, each protuberance may have a thickness between about 4 mm to about 5 mm at the inner end. In some embodiments, each protuberance may have a thickness between about 1 mm to about 3 mm at the outer edge. In some embodiments, each protuberance may have a thickness between about 1 mm to about 2 mm at a middle portion between the inner end and the outer edge. In some embodiments, the thicknesses protuberances may be variously configured. For example, row of protuberances 22 may include a greater thickness at the inner end and outer edge than row of protuberances 32. Alternatively, individual protuberances may have varied thicknesses in relation to adjacent protuberances.

[0087] The protuberances are arranged in a radial array about the body 204 of fitting 10. As shown in FIGS. 1-5, there are four protuberances in each row, such that each protuberance occupies less than 90° of the radial space around the body. The distance between each is shown as arc 206 and the distance is configured to allow the protuberances to extend and engage the lining of the biological lumen. In some embodiments, the protuberances are spaced apart by a distance between about 0.1 mm to about 10 mm, about 1 mm to about 7 mm, or about 3 mm to about 6 mm. In other embodiments, there may be less space between protuberances to accommodate embodiments which include an amount greater than four protuberances. The protuberances taper such that each outer edge occupies less than 30° of the radial space around the body. In some embodiments, the protuberances widen along their length such that each outer edge occupies about 90° of the radial space around the body.

[0088] In various embodiments, protuberances 22, 32 are angled relative to the longitudinal axis L of fitting 10. As shown, for example, in FIGS. 3 and 4, protuberances 22, 32 are angled at an angle of about 45° relative to the longitudinal axis. In some embodiments, for example, in embodiments where protuberance includes a reinforced portion 28, 38, the angle at the base of the protuberance does not change when the protuberances are being flexed by an external force, as discussed herein. For example, in embodiments in which the protuberances do not include a reinforced portion, the angle at the base of the protuberance changes to a degree depending on the extent of force applied to it.

[0089] In various embodiments, when the protuberances 22, 32 are in a resting position, they are acutely angled with respect to the body 204 of fitting 10. In some embodiments, the protuberances are positioned at an angle of about 5° to about 85° with respect to longitudinal axis L of fitting 10. In some embodiments, the protuberances are positioned at an angle of from about 35° to 75°, 45° to 70°, 50° to 65° or 55° to 60° from the cover's central longitudinal axis. In some embodiments, the protuberances are positioned at an angle of about 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, or 85° relative to longitudinal axis L. In some embodiments, protuberances 22 extending from member 20 are sloped at a more acute angle than protuberances 32 extending from member 30.

[0090] In some embodiments, as shown in FIGS. 4A and 4C, the protuberances are movable to an extended configuration. As discussed herein, the protuberances are configured to flare outward relative the longitudinal axis L. For example, as shown in FIG. 4C, protuberances 151, 155 are movable to and angle that is greater than the angle of orientation of the protuberances in the rest position. The protuberances 151 are movable to a first angle EE, and the protuberances 155 are movable to a second angle FF. In some embodiments, angles EE, FF are between about 10° to 180°, 45° to 135°, or about 85° to 95°. In some embodiments, the protuberances are positioned at an angle of about 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180° relative to longitudinal axis L when in the extended configuration. In some embodiments, angles EE and FF are movable to the same angle when in the extended position. In other embodiments, angles EE and FF are movable to different angles when in the extended position.

[0091] In some embodiments, each of the protuberances 22, 32 are formed from a common elastomeric material so that each of the protuberances possesses common physical properties, such as flexibility. In some embodiments, protuberances that comprise a longer length relative to other protuberances are formed from a more flexible elastomeric material than protuberances of a relatively shorter length.

[0092] In some embodiments, protuberances 22, 32 extend substantially straight from the body of fitting 10. In some embodiments, one or more protuberances include a contoured outer edge that is free of sharp edges or points so as to prevent damage to the interior of the biological lumen. Further, the contoured edge acts as a catch when fitting 10 is moved proximally in a biological lumen. The contoured edge provides an initial tissue contacting surface such that when friction is created between the protuberance and the lining, the protuberance moves radially outward from the body and expands to a larger diameter so as to unfold the fold in the biological lumen.

[0093] In some embodiments, protuberances 22, 32 are biased to a rest position. As shown in FIGS. 1-5, protuberances 22, 32 are angled in the rest position such that the outer edges of the protuberances face toward proximal end 14 of fitting 10. The flexibility of protuberances 22, 32 allows them to bend either in the proximal direction or the distal direction. Protuberances 22, 32 are movable between a first position, in which protuberances 22, 32, are in a compressed configuration or flat configuration radially inward toward the body 204, and a second position, in which protuberances 22, 32 are in an expanded configuration or projecting radially outward from the body 204. In the first position, the protuberances are pressed toward the body of fitting 10 such that the outer edges of the protuberances move inwardly. When in the first position, fitting 10 has a flat or thinner profile to enable an endoscope to easily be advanced through a biological lumen.

[0094] In the second position, the protuberances are expanded radially outward from the body of fitting 10 such that the outer edges of the protuberances move distally from the body. When in the second position, fitting 10 has a wider profile to facilitate contact with the lining of the biological lumen and ability to unfold the folds in the biological lumen for viewing. The protuberances exert a frictional force upon the lining of a biological lumen when in the second position so as to gently force apart the contacted folds that are present in the lining.

[0095] In some embodiments, the outer edges of each of the protuberances 22, 32 include a tissue contacting surface configured to engage the lining of a biological lumen. Protuberances 22, 32 comprise an elastomeric material which has a rubbery gripping surface to facilitate the engagement with the lining by maximizing friction created between the surface and the lining. [0096] When advanced through the biological lumen, the angle at which protuberances 22, 32 are disposed with fitting 10 enables the endoscope to glide through the biological lumen with little resistance. However, when the endoscope is retracted and moved in a proximal direction, the outer edges of the protuberances 22, 32 contact the lining of the lumen and flare outward to the second position. The outer edges of the protuberances are blunt so as to avoid damage to tissue during the transition from the first position to the second position. Since protuberances 22, 32 are biased to the rest position, when the protuberances are in the second position; they exert an outward force on the lining of the lumen and create a wider area for the endoscope to visualize.

[0097] FIGS. 6-8 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A first cylindrical member 20a is attached to a second cylindrical member 30a. Cylindrical member 20a includes protuberances 22a, and cylindrical member 30a includes protuberances 32a. Protuberances 22a, 32a are arranged in rows and extend outward from cylindrical members 20a, 30a, respectively, between an inner end and an outer edge. Protuberances 22a, 32a are each evenly spaced apart from one another and radially arranged in rows about the body of fitting 10. The rows of protuberances 22a, 32a may be arranged such that the protuberances of neighboring rows are staggered with respect to one another as shown in Figure 7. Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another (not shown).

[0098] As shown in FIGS. 6-8, protuberances 22a, 32a include variable thicknesses along their lengths to affect the flexibility of the protuberances. For example as shown in FIGS. 6 and 7, each protuberance 22a includes a narrowed portion 26a, and each protuberance 32a includes a similar narrowed portion 36a. The narrowed portions 26a, 36a begins at or near the middle portion of the protuberance between the inner ends and outer edges and comprises a region of decreased thickness. The decreased thickness allows for greater flexibility at the outer edges of the protuberance. Thus, the configuration of protuberances 22a, 32a create customized, differing or varied flexibility which allows for a greater degree of flexibility toward the outer end of the protuberances. Therefore the force required to bend or the bending moment can be increased or decreased as desired. In some embodiments, by increasing the thickness at discrete regions of the protuberance, a reinforced region can be made, such as that shown in the reinforced region 28, 38 of FIGS. 4 and 4A. This region can have increased thickness relative to the middle portion and outer edge of the protuberance. In the embodiments shown in FIGS. 6-8, protuberances have a wider inner end 200 with increased surface area relative to the narrower outer edge 202 of the protuberance.

[0099] FIGS. 9-11 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A first row of protuberances 22b is positioned above a second row of protuberances 32b. As shown in FIGS. 9- 11, all protuberances are monolithic. In some embodiments, all protuberances are molded from the same material, and protuberances 22b, 32b are not separable from one another. Protuberances 22b, 32b are arranged in rows and extend outward from the body of fitting 10 between an inner end 200 and an outer edge 202. Protuberances 22b, 32b are each evenly spaced apart from one another and radially arranged in rows about the body of fitting 10. The rows of protuberances 22b, 32b may be arranged such that the protuberances of neighboring rows are staggered with respect to one another (shown). Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another (not shown). In the embodiments shown in FIGS. 9-11, protuberances have a wider inner end 200 with increased surface area relative to the narrower outer edge 202 of the protuberance.

[00100] As shown best in FIGS. 9 and 10, protuberances 32b include a flared edge 203 at the outer edge, where there is a widening of the edge. FIGS. 9 and 10, show protuberances at their rest position where there is no external force applied to the protuberance. The flared edge 203 aids in gripping of the lining of a biological lumen during extubation or proximal movement of the endoscope. Specifically, the flared edges act as catches when fitting 10 is moved proximally in a biological lumen, which causes the outer ends of the protuberances to extend outwardly into the second position as disclosed herein. Flared edges are made from an elastomeric material so as to avoid damage to tissue during movement of the endoscope and transition between the first and second positions of the protuberances. Protuberances 22b, 32b include variable thicknesses along their lengths to affect the flexibility of the protuberances, similar to protuberances 22a, 32a. For example, each protuberance 22b includes a narrowed portion 26b, and each protuberance 32b includes a similar narrowed portion 36b. The narrowed portions 26b, 36b begins at or near the midpoint between the inner ends 200 and outer edges and comprises a region of decreased thickness. The decreased thickness allows for greater flexibility at the outer edges 202 of the protuberance. Thus, the configuration of protuberances 22b, 32b create customized, differing or varied flexibility which allows for a greater degree of flexibility toward the outer end of the protuberances.

[00101] As shown best in FIG 11, in some embodiments, fitting 10 includes a lip 19 at the distal end of the body. Lip 19 comprises an overmolded portion extending inward over the channel to receive an endoscope. Lip 19 serves as a stop for the distal tip of an endoscope. A medical practitioner inserts the endoscope through the channel 214 until the tip contacts lip 19 to ensure that fitting 10 is secured to the endoscope. The opening in the fitting does not impair the camera view of the endoscope.

[00102] FIGS. 12-14 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A first cylindrical member 20c is attached to a second cylindrical member 30c. Cylindrical member 20c includes protuberances 22c, and cylindrical member 30c includes protuberances 32c. Protuberances 22c, 32c are arranged in rows and extend outward from cylindrical members 20c, 30c, respectively, between an inner end 200 and an outer edge 202. Protuberances 22c, 32c are each evenly spaced apart from one another and radially arranged in rows about the body of fitting 10. The rows of protuberances 22c, 32c may be arranged such that the protuberances of neighboring rows are staggered with respect to one another. Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another.

[00103] As shown in FIGS. 12-14, protuberances 22c, 32c are wide at their inner ends 200 and taper to a narrower region at their outer edges 202. Unlike protuberances 22, 32, protuberances 22c, 32c do not include central windows. Protuberances 22c, 32c are configured to be solid to impart properties of greater structural stability. Furthermore, in some embodiments, protuberances 22c, 32c include notches, such as, for example, recesses or notches 26c, 36c. Recesses or notches 26c, 36c provide desired flexibility as the thickness in these areas is reduced to provide the pivot points. In some embodiments, they are disposed in the middle portion 208 of the protuberance and provide pivot points so that the outer edges 202 of the protuberance can be bent from side to side, which enables a medical practitioner to turn, withdraw or move forward an endoscope within the biological lumen without potentially damaging tissue. It will be understood by those of ordinary skill in the art that although one recess or notch is shown on each protuberance, two, three, four, five, six or more recesses or notches can be on one protuberance to have the desired flexibility. [00104] FIGS. 15-17A and B illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A first cylindrical member 20d is attached to a second cylindrical member 30d. Cylindrical member 20d includes protuberances 22d, and cylindrical member 30d includes protuberances 32d. Protuberances 22d, 32d are arranged in rows and extend outward from cylindrical members 20d, 30d, respectively, between an inner end 200 and an outer edge 202. Protuberances 22d, 32d are each evenly spaced apart from one another and radially arranged in rows about the body of fitting 10. The rows of protuberances 22d, 32d may be arranged such that the protuberances of neighboring rows are staggered with respect to one another. Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another. Each row of protuberances 22d, 32d includes six protuberances. However, in other embodiments, there may be more or less than six in each row. Inner end 200 of the protuberance extends to middle portion 201 then to outer edge 202. Middle portion 201 of the protuberance is narrow in width and/or surface area relative to inner end 200 and outer edge 202, which will have a larger width and/or surface area. In some embodiments, the protuberance is designed so that the inner end 200 has a larger width and/or surface area and then becomes narrower in width and/or surface area at the middle portion 201 and then width and/or surface area increases at the outer edge 202. One reason for this is that it reduces the amount of force per area on the lining of the biological lumen wall, by increasing the surface area touched by the outer edge of the protuberance. The friction of the fitting against the wall helps to unfold the biological lumen as the medical scoping device is withdrawn rather than just having the protuberances press more firmly against it.

[00105] In various embodiments, the inner end 200 of the protuberance will have a larger width than the middle portion 201. The inner end will have a width of from about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm, 3.25 mm, 3.5 mm, 3.75 mm, 4 mm, 4.25 mm, 4.5 mm, 4.75 mm, to about 5 mm in width. The width can vary throughout the fitting and/or along the protuberance to achieve the desired flexibility.

[00106] In various embodiments, middle portion 201 of the protuberance will have a smaller width than the inner end 200 of the protuberances. The middle portion 201 will have a width of from about 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm. The width can vary throughout the fitting and/or along the protuberance to achieve the desired flexibility. [00107] In various embodiments, the outer edge 202 of the protuberance will have a larger or smaller width than the middle portion 201. The outer edge 202 will have a width of from about 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3.0 mm, 3.25 mm, 3.5 mm, 3.75 mm, 4 mm, 4.25 mm, 4.5 mm, 4.75 mm, to about 5 mm in width. The width can vary throughout the fitting and/or along the protuberance to achieve the desired flexibility.

[00108] In some embodiments, the width of the protuberance, especially nearest the body of the fitting, is narrower than the circumference of the fitting. For instance, there is a 360 degree arc length of the fitting, and the protuberance at the body may be, for example, less than 90 degrees of that arc length. In some embodiments, at the outer edge of the protuberance, it is preferred if the total 360 degrees is covered. One reason for this is that it increases surface area and width to touch the biological lumen wall, but at the body of the fitting there is room for colonic debris to pass as the medical scoping device is inserted.

[00109] As shown in FIGS. 15- 17 A, protuberances 22d, 32d are wide at their inner ends and outer edges, and are narrow in a middle portion between the inner ends and the outer edges. The inner ends and outer edges of protuberances 22d, 32d are wider to impart properties of greater structural stability. Additionally, the wideness of the outer edges is configured to provide a greater surface area for gripping a lining of a biological lumen. Further, it reduces the amount of force per area on the lining of the biological lumen wall, by increasing the surface area touched by the outer edge of the protuberance. The friction of the fitting against the wall helps to unfold 22d, 32dthe biological lumen as the medical scoping device is withdrawn rather than just having the protuberances press more firmly against it.

[00110] Protuberances 22d, 32d comprise ridges 28d, 38d at the outer edges. Ridges 28d, 38d are raised surfaces which enhance the engagement of protuberances 22d, 32d with the lining of a biological lumen. Ridges 28d, 38d include a curved surface formed from a material having enhanced gripping properties. Furthermore, in some embodiments, protuberances 22d, 32d include notches, such as, for example recesses or notches 26d, 36d. Recesses or notches 26d, 36d provide an easily flexible point along the length of the protuberances 26d, 36d which are configured to flex prior to flexure of the rest of the protuberance.

[00111] Protuberances 22d, 32d taper outward such that each outer edge occupies more than 30° of the radial space around the body. In some embodiments, the protuberances widen along their length such that each outer edge occupies between about 30° and about 60° of the radial space around the body. In some embodiments, the outer edges contact adjacent outer edges such that the outer edges encompass 360° of the radial space around the body 204.

[00112] FIG. 17A illustrates a top view of the fitting shown in FIG. 15. FIG. 17B illustrates a bottom view of the fitting shown in FIG. 15, the notches or recesses 31 shown in this view in the middle region of the protuberance increase flexibility of the outer edges of the protuberances and the protuberances 22d, 32d span slightly less than 360 degrees around the body 35 of the fitting. This may allow colonic debris to pass by the fitting in use.

[00113] The outer edges 39 of the protuberances have increased width and/or surface area compared to the middle portion of the protuberance and the inner end 41 of the protuberance that will increase contact with the biological lumen lining. To reduce damage of the lining of the biological lumen, the outer edges 39 of the protuberances are contoured. Opening 45 is configured to receive the distal end of the medical scoping device. The body 35 of the fitting, in some embodiments, may have ribs 37 to allow a snug fit with the distal end of the medical scoping device. In some embodiments, the opening 45 may have a diameter that is the same or slightly larger than the diameter of the medical scoping device so that when the fitting is placed on the distal end of the medical scoping device it fits snugly over it.

[00114] FIGS. 18-20 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A first cylindrical member 20e is attached to a second cylindrical member 30e. Cylindrical member 20e includes protuberances 22e, and cylindrical member 30e includes protuberances 32e. Protuberances 22e, 32e are arranged in rows and extend outward from cylindrical members 20e, 30e, respectively, between an inner end and an outer edge. Protuberances 22e, 32e are each evenly spaced apart from one another and radially arranged in rows about the body of fitting 10. The rows of protuberances 22e, 32e may be arranged such that the protuberances of neighboring rows are staggered with respect to one another. Alternatively, the rows of protuberances may be arranged such that the protuberances of neighboring rows are aligned with one another.

[00115] As shown in FIGS. 18-20, protuberances 22e, 32e are wider at its outer edge 202 and taper to a narrower configuration in their middle portion 201 until the narrowest portion at the inner end 200. Inner end 200 of the protuberance extends to middle portion 201 then to outer edge 202. Inner end 200 of the protuberance is narrow in width and/or surface area relative to middle portion 201 and outer edge 202, which will have a larger width and/or surface area. In some embodiments, the protuberance is designed so that the inner end 200 has a smaller width and/or surface area and then becomes wider in width and/or surface area at the middle portion 201 and then the width and/or surface area increases at the outer edge 202. In some embodiments, width of the protuberance, especially nearest the body 204 of the fitting, is narrower than the circumference of the fitting. For instance, there is a 360 degree arc length of the fitting, and the protuberance at the body should be, for example, less than 90 degrees of that arc length. In some embodiments, the outer edge of the protuberance is preferably flared and 360 degrees of the arc length is covered. One reason for this is that it increases surface area and width to touch the biological lumen wall, but at the body 204 of the fitting there is room for colonic debris to pass as the medical scoping device is inserted. In the embodiment shown in FIG. 20, the protuberances are unfolded and radially arrayed 360 degrees about the body of the fitting.

[00116] Unlike protuberances 22, 32, protuberances 22e, 32e do not include central windows. Protuberances 22e, 32e have a shape which linearly widens from the inner end to the outer edge and are configured to be solid to impart properties of greater structural stability. Furthermore, in some embodiments, protuberances 22e, 32e include notches, such as, for example recesses or notches 26e, 36e. Recesses or notches 26e, 36e provide an easily flexible point along the length of the protuberances 26e, 36e which are configured to flex prior to flexure of the rest of the protuberance. The protuberances are angled in the embodiment shown in a downward direction relative to the body. In some embodiments, the protuberances are positioned at an angle of from about 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, or 85° in a downward direction relative to the body 204, when the fitting is at a resting position (e.g., there is no external force applied to it by the lining of the biological lumen).

[00117] FIGS. 21-23 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A cylindrical body 20f includes protuberances 22f, which are arranged in a row and extend outward from cylindrical body 20f between an inner end and an outer edge. Protuberances 22f are evenly spaced apart from one another and radially arranged in a row about the body of fitting 10. In some embodiments, fitting 10 also comprises a cylindrical extender 40 at the distal end of fitting 10. Cylindrical extender 40 is configured to provide a means to spread tissue as an endoscope is advanced through a biological lumen. In some embodiments, cylindrical extender 40 is transparent or semi-transparent to allow visualization through its surface. [00118] The cylindrical extender 40 can be monolithic with the remainder of the fitting (e.g., one piece), alternatively the cylindrical extender can have a diameter that allows it to fit over the fitting which has the medical scoping device head in it. Alternatively, the fitting can be over the distal end of the endoscope first then the cylindrical extender can abut or contact the fitting, such that there are two separate pieces (e.g., the fitting and the cylindrical extender).

[00119] The fitting can be soft so as to not damage the lining of the biological lumen. The fitting can be used with suction so as to allow the lining of the biological lumen to collapse around the fitting to further increase visualization and then other elements can be used in conjunction with the fitting (e.g., surgical cutting instruments to remove tissue (e.g., mucosal lining resection), or cauterize tissue, biopsy tissue, etc.).

[00120] FIGS. 21-23 illustrate a fitting 10 similar to that illustrated in FIGS. 1-5. A cylindrical body 20f includes protuberances 22f, which are arranged in a row and extend outward from cylindrical body 20f between an inner end and an outer edge. Protuberances 22f are evenly spaced apart from one another and radially arranged in a row about the body of fitting 10. In some embodiments, fitting 10 also comprises a cylindrical extender 40 at the distal end of fitting 10. Cylindrical extender 40 is configured to provide a means to spread tissue as an endoscope is advanced through a biological lumen. In some embodiments, cylindrical extender 40 is transparent or semi-transparent to allow visualization through its surface.

[00121] Protuberances 22f may have an inner end and an outer edge and a recess of notch 26f of reduced thickness disposed in the middle portion of the protuberance to enhance flexibility.

[00122] FIG. 24 illustrates a side view of an embodiment of a medical scoping device fitting 10 in accordance with the principles of the present disclosure. FIG. 24 illustrates a side view of the fitting 10, which has a longitudinal axis L. Top 44 of fitting 10 is configured to engage the distal end of an endoscope, as shown in FIGS 24A and 24B. In some embodiments, top 44 includes a lip on an inner surface configured to serve as a stop for the distal tip of an endoscope. A medical practitioner inserts the endoscope through channel 60 of fitting 10 until the tip contacts the lip to ensure that fitting 10 is secured to the endoscope. Channel 60 extends through the entire length of or substantially the entire length of fitting 10, and is configured to engage and receive the distal end of the medical scoping device. In some embodiments, the body of the fitting can expand around the medical scoping device to provide a snug fit around it so that it does not detach from the distal end of the medical scoping device. [00123] In some embodiments, leading end 42 of top 44 is soft and smooth to facilitate entry into a biological lumen. Fitting 10 further includes a side wall 43 extending between proximal and distal ends of the fitting. In some embodiments, side wall 43 has a smooth finish. The body of fitting 10 includes a plurality of compressible members 52 configured to move between a low profile configuration and an expanded configuration. In some embodiments, fitting 10 includes five compressible members 52 separated by recesses 51. However, in other embodiments, fitting 10 may include more or less compressible members 52. For example, fitting 10 may include one, two, three, four, six, seven, eight, nine or ten compressible members 52.

[00124] Compressible members 52 extend along longitudinal axis L of fitting 10. Members 52 include a middle section 50 having an interior cutout, as shown in FIG. 24. The cutout of section 50 defines a lesser thickness than surrounding portions of members 52 to provide a zone of increased flexibility. Thus, upon moving from the low profile configuration to the expanded configuration, members 52 have a tendency to fold at middle sections 50. In some embodiments, compressible members 52 comprise a second cutout 48 at a proximal end adjacent side wall 43. Cutout 48 biases members 52 to fold toward the proximal direction when in the expanded configuration.

[00125] The lower end of the body comprises protuberances 54 configured to engage with the walls of a biological lumen. The surface of each protuberance has one or more raised surfaces 58 extending transversely from protuberance 54. It will be understood that the protuberance 54 may have one, two, three, four, five, six or more raised surfaces on the protuberance. Raised surfaces 58 aid in the frictional contact with the lining of the biological lumen. When raised surfaces 58 engage tissue and the endoscope is retraced distally, a force is applied to the raised surfaces to cause a change in shape of the fitting. Each protuberance 54 has a contoured surface 56, which reduces damage to the lumen lining when protuberance 54 comes in contact with it.

[00126] FIGS. 24A and 24B illustrate the movement of fitting 10 between the low profile configuration and the expanded configuration. As shown in FIG. 24A, when in the low profile configuration, members 52 are stretched so as to lie flatly against the surface of an endoscope 50. When in this configuration, the endoscope and fitting can easily slide through a biological lumen. As shown in FIG. 24B, when in the expanded configuration, members 52 flare outward to create a greater circumference of fitting 10. In some embodiments, middle section 50 and cutout 48 include areas of lesser thickness to create increased flexibility. When in the expanded configuration, members 52 bend at middle section 50 and flex in a direction toward cutout 48. In other embodiments, members 52 include a uniform thickness and flexibility along their entire length. In Figure 24B, the raised surfaces 58 are compacted or squished closer to leading end 42. In this way, the protuberance 54 can cause friction against the lumen lining and unfold the lining of the biological lumen so that it can be viewed. The length of the fitting, in this embodiment, is reduced in the compacted or squished configuration and therefore, the fitting changes its shape or configuration as shown in Figure 24B.

[00127] FIG. 25 illustrates a bottom view of the fitting 10 shown in FIG. 24. The bottom of the fitting has opening 60, which is configured to receive the endoscope. The fitting has circular member 64 and rib 62 that are configured to provide support and a snug fit around the distal end of the endoscope. Each protuberance is spaced apart by a distance in arc 68 and the protuberance can have a contoured border 66 that also prevents damage to the lining of the biological lumen. Interior 61 is configured to receive the medical scoping device. Exterior 63 has the protuberances disposed on it.

[00128] FIG. 26 illustrates a top view of the fitting shown in FIG. 24. Inner end 74 of the protuberance is shown when it is flat with the body of the fitting. The top 44 of the fitting has opening 70, which is configured to receive the distal end of the endoscope. The diameter of the fitting D has a diameter that is slightly larger than the distal end of the endoscope so that it can cover it and not obstruct the view of the camera or working filed in the endoscope. Leading end 42 of the top of the fitting is smooth for ease of insertion. Circular element 72 around the fitting provides support and allows the fitting to fit snuggly on the endoscope.

[00129] FIG. 29A illustrates a perspective view of an embodiment of a medical scoping device fitting 10 in accordance with the principles of the present disclosure. The fitting illustrated is a two component system, having an upper member 100 and a lower member 114 where two rows of protuberances are present and the fitting can be simply assembled. The upper member 100 can be more flexible than lower member 114. The diameter D2 of the upper member 100 is larger than the diameter D3 of the lower member so that the lower member can engage upper member through opening 102 so that lower member can fit snuggly within the upper member 100. Upper member 100 comprises a row of protuberances arranged radially around the upper member. Each protuberance comprises window 110 for the desired flexibility and support of the fitting. Each protuberance can have inner edge 104, which is wider in this embodiment than outer edge 106 of the protuberance. In the middle portion of the protuberance there is a recess or notch 108 to allow the desired flexibility of the protuberance. Each protuberance is spaced apart from each other and has a ridge 112 that engages and can lock into position when contacting ridge 116 of the lower member 114.

[00130] Lower member 114 of the fitting 10 can be more rigid and less flexible than the upper member 100. The lower member 104 comprises a row of protuberances arranged radially around the lower member. Each protuberance comprises window 120 for the desired flexibility and support of the fitting. Each protuberance can have ridge 116 that contacts ridge 112 when the lower member 104 is slid into opening 102 of the upper member 100. Ridge 118 of the lower member can provide structural support to the lower member 114. In the middle portion of the protuberance there is a recess or notch 122 to allow the desired flexibility of the protuberance. The distal end of the medical scoping device will be put in opening 103 and 102 once the upper member and lower members are assembled and aligned. The lower member includes ribs 124 which engage the endoscope.

[00131] FIG. 29B illustrates a perspective view of a partially assembled medical scoping device fitting shown in 29A, where the upper member 100 slides over the lower member 114. FIG. 29C illustrates a perspective view of an assembled medical scoping device fitting shown in 29A, where the upper member 100 is on lower member and upper member 100 stops at ridge 118 of lower member to prevent upper member from being positioned past ridge 118. The fit between upper and lower member is snug and the lower member 114 would need to be deformed to detach upper member 100 from lower member 114.

[00132] It will be understood by those of ordinary skill in the art that the body passage device and one or more of its components can be sterilized and reused. Alternatively, and more preferred, one or more components of the body passage device can be disposable and disposed of after single use.

[00133] It will be appreciated that the fitting of the present application can be constructed with various diameters so that it may be used to fit over the shaft of existing medical scoping devices. For example, pediatric scoping devices comprise shaft diameters of around 11 mm whereas an adult scoping device shaft diameter is in the region of 12 mm, the fitting of the present application may be constructed with suitable diameters according to a user's requirements. Method of Use

[00134] In use, the disclosed fitting comprises protuberances which are configured to expand the lining of a biological lumen. Described herein is a method for using a device, such as fitting 10, with an endoscope to increase visualization of the colon or other biological lumens during endoscopic procedures. The fitting includes an array of protuberances which are configured to grasp onto and expand a biological lumen without incurring any damage to tissue. Prior to an endoscopic procedure, a medical practitioner obtains an endoscope and attaches fitting 10 at or near the distal tip of said endoscope. This can be done by hand or with a hand tool. The endoscope is passed into channel 16 of fitting 10 that is configured to receive an endoscope. Ribs 18 extend along the length of channel 16 and increase a friction fit between fitting 10 and the sidewall of an endoscope.

[00135] Once the endoscope is outfitted with fitting 10, it is inserted into the biological lumen of a patient. On inserting the endoscope, protuberances 22, 32 are moved from the rest position to a first position where they are flattened towards the proximal end of the fitting. When in the first position, fitting 10 has a thinner profile to enable an endoscope to easily be advanced through a biological lumen. During intubation, protuberances 22, 32 are configured to collapse into the device during insertion through an opening into a biological lumen, such as a sphincter. When advanced through the biological lumen, the angle at which protuberances 22, 32 are disposed with fitting 10 enables the endoscope to glide through the biological lumen with little resistance. Specifically, the leading row of protuberances may be angled more acutely in the proximal direction to assist in easy insertion. Additionally, the leading row of protuberances may include a shorter length than the trailing row of protuberances to minimize resistance of movement in the distal direction. In some embodiments, the leading row of protuberances is formed from a material which causes less friction against the lining of the biological lumen.

[00136] The flexible shaft of the endoscope is advanced distally through the biological lumen until a medical practitioner reaches a spot where increased visualization is desired. Once a medical examiner reaches a desired location, distal advancement of the endoscope stops. This causes protuberances 22, 32 to return to the rest position. The medical practitioner draws the endoscope proximally an amount as needed to cause a threshold amount of friction between the protuberances and the lining of the biological lumen. When the endoscope is retracted and moved in a proximal direction, the outer edges of the protuberances 22, 32 grip the lining of the lumen and flare outward to the second position. The outer edges of the protuberances are blunt and made from an elastomeric material so as to avoid damage to tissue during the transition from the first position to the second position. Once in the second position, tissue contacting surfaces on the underside of protuberances 22, 32 are configured to grip the lining of the biological lumen to anchor the endoscope in place. When in the second position, fitting 10 has a wider profile to facilitate anchoring into the lining of a biological lumen. The protuberances exert a mechanical force upon the lining of a biological lumen when in the second position so as to force apart any folds which are present in the lumen wall. Since protuberances 22, 32 are biased to the rest position, when the protuberances are in the second position, they are able to exert an outward force on the lining of the lumen and create a wider area for the endoscope to visualize.

[00137] Once expanded, the medical practitioner may visualize a portion of the biological lumen as necessary. The medical practitioner may then advance the endoscope distally to further view other portions as desired. After the visualization is complete, the medical practitioner withdraws the endoscope by moving it proximally until it is completely removed from the biological lumen of the patient.

[00138] FIG. 27 illustrates a schematic anatomical section of a medical scoping device fitting of the present application in the course of a medical scoping procedure. FIG. 27 shows insertion of the scoping device into the colon 90 of an individual undergoing an endoscopic procedure. The protuberances, one shown as 86, is flattened and moving radially inward toward the bottom 84 of the fitting 87 (shown as a cap) as the fitting enters the colon and the protuberances 86 are compressed by the colon wall. The fitting 87 covers the endoscope 80. At the top 82 of the fitting, there is an opening for the camera of the endoscope as it approaches a fold 88 in the colon.

[00139] FIG. 28 illustrates a schematic anatomical section of a medical scoping device fitting of the present application shown in FIG. 27 in the course of a medical scoping procedure, where the protuberance 86 moves radially outward as the endoscope 80 is withdrawn from the colon and protuberances unfold the fold 88 in the colon to improve visualization out of the top 82 of the fitting of the colon lining 92, alternatively this can be accomplished by air suction causing the colon wall to collapse or wrap around the fitting. The bottom 84 of the fitting has other protuberances attached to it such as protuberance 85, which is in the resting position. Method of Making the Fitting

[00140] In some embodiments, fitting 10 may be made by injection molding, compression molding, blow molding, thermoforming, die pressing, slip casting, electrochemical machining, laser cutting, water-jet machining, electrophoretic deposition, powder injection molding, sand casting, shell mold casting, plaster-mold casting, investment casting, vacuum casting, permanent-mold casting, slush casting, pressure casting, die casting, centrifugal casting, squeeze casting, rolling, forging, swaging, extrusion, shearing, spinning, or combinations thereof.

[00141] In some embodiments, the fitting may be formed by 3D printing. Instructions in the form of schematics encompassing any of the embodiments disclosed herein may be given to a computer to be carried out by a 3D printer. An elastomeric material, such as a silicone-based elastomer may be fed into a reservoir to be used to form the fitting. In some embodiments, the components of the fitting may be color coded to signify various physical properties. For example, different colors may be used to differentiate between varying amounts of friction or flexibility between components. Once the material is chosen, an elastomeric material is deposited over a flat fabrication platform one layer at a time. Once a first layer is deposited, a second layer is deposited on top of the first layer. The process is repeated as necessary to create the fitting to the specifications enumerated in the instructions.

[00142] Another form of manufacturing the fitting involves casting the elastomeric material in a mold. The elastomeric material can take on the shape of the mold such as, crescent, quadrilateral, rectangular, cylindrical, plug, or any other shape. Additionally, the surface of the mold may be smooth or may include raised features or indentations, for example indentations to create the recesses or notches, to impart features to the fitting. Features from the mold can be imparted to the fitting as the elastomeric material in the mold is dried. In particular aspects, a roughened or friction engaging surface can be formed on the upper surface and/or the lower surface of the fitting body. In some embodiments, protuberances or raised portions can be imparted on the upper surface and/or the lower surface from the mold. Kits

[00143] The disclosed fitting and endoscope may be sterilizable. In various embodiments, one or more components of the fitting and/or endoscope may be sterilizable by radiation in a terminal sterilization step in the final packaging. Terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment.

[00144] Typically, in various embodiments, gamma radiation is used in the terminal sterilization step, which involves utilizing ionizing energy from gamma rays that penetrates deeply in the device. Gamma rays are highly effective in killing microorganisms, they leave no residues nor have sufficient energy to impart radioactivity to the device. Gamma rays can be employed when the device is in the package and gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed. In addition, gamma radiation eliminates the need for permeable packaging materials.

[00145] In some embodiments, the one or more components of the fitting may be packaged in a moisture resistant package and then terminally sterilized by gamma irradiation. In use, the medical practitioner performing the endoscopic procedure removes the one or all components from the sterile package for use.

[00146] In various embodiments, electron beam (e-beam) radiation may be used to sterilize one or more components of the fitting. E-beam radiation comprises a form of ionizing energy, which is generally characterized by low penetration and high-dose rates. E-beam irradiation is similar to gamma processing in that it alters various chemical and molecular bonds on contact, including the reproductive cells of microorganisms. Beams produced for e-beam sterilization are concentrated, highly-charged streams of electrons generated by the acceleration and conversion of electricity.

[00147] Other methods may also be used to sterilize the fitting and/or one or more components of the fitting, including, but not limited to, gas sterilization, such as, for example, with ethylene oxide or steam sterilization.

[00148] In various embodiments, a kit is provided comprising the components of the fitting and an endoscope. The kit may include additional components along with the fitting, such as additional sets of protuberances. The kit may include the fitting in a first compartment. A second compartment may include an endoscope. A third compartment may include additional sets of protuberances, as well as an instruction booklet, which may include a chart that shows how to install and use the fitting. A cover of the kit may include illustrations of the installation and endoscopic procedure and a clear plastic cover may be placed over the compartments to maintain sterility.

[00149] It will be apparent to those skilled in the art that various modifications and variations can be made to various embodiments described herein without departing from the spirit or scope of the teachings herein. Thus, it is intended that various embodiments cover other modifications and variations of various embodiments within the scope of the present teachings.

Claims

WHAT IS CLAIMED IS:

1. A fitting for a medical scoping device, the fitting comprising a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive the medical scoping device along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and radially arrayed with respect to one another and extending from the body of the fitting, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance.

2. A fitting of claim 1, wherein (i) the protuberances are arranged into first and second rows, wherein the first row is disposed with the first region of the fitting and the second row is disposed with the second region of the fitting; (ii) the medical scoping device comprises an endoscope, an enteroscope, a sigmiodoscope, a gastroscope, a colonoscope, or a

panendoscope; (iii) each outer edge of the protuberance is bendable in an upward or downward direction relative to the body; (iv) the body comprises a top, each protuberance being angled less than 90 degrees relative to the longitudinal axis of the body and each protuberance being angled generally in a downward direction relative to the top of the body; or (v) the body comprises a top and bottom, each outer edge of the protuberance is bendable at an angle of 0 degrees to 180 degrees relative to the longitudinal axis of the body and each protuberance being angled generally in a downward direction relative to the top of the body.

3. A fitting of claim 2, wherein (i) the protuberances of the first row are spaced apart from one another, the protuberances of the second row are spaced apart from one another, and the first and second rows are staggered with respect to one another; or (ii) the fitting comprises a covering or cap for an endoscope.

4. A fitting of claim 2, wherein (i) the protuberances of the first row comprise a length from the inner end to the outer edge that is less than a length of the protuberances of the second row; or (ii) the protuberances of the first row are biased at an angle greater than an angle of the protuberances of the second row.

5. A fitting of claim 1, wherein (i) each protuberance includes an area of a first degree of flexibility at the inner end and at the outer edge and an area of a second degree of flexibility in a middle portion between the inner end and the outer edge, the second degree of flexibility being greater than the first degree of flexibility; (ii) each protuberance comprises a middle portion having a recess that increases flexibility of the outer edge relative to the inner end of each protuberance; or (iii) each protuberance has a middle portion disposed between the inner end and the outer edge and the middle portion has a width or surface area smaller than the width or surface area of the outer edge or the inner end.

6. A fitting of claim 1, wherein (i) the body of the fitting is monolithic; (ii) the fitting comprises a first cylindrical portion comprising the first region and a second cylindrical portion comprising the second region, the first cylindrical portion separable from the second cylindrical portion; or (iii) the fitting comprises a first cylindrical portion comprising the first region and a second cylindrical portion comprising the second region, the first cylindrical portion separable from the second cylindrical portion and the first cylindrical portion being more flexible than the second cylindrical portion.

7. A fitting of claim 6, wherein the first cylindrical portion is configured to retain the second cylindrical portion, the first cylindrical portion including at least one locking member to engage an inner surface of the second cylindrical portion.

8. A fitting of claim 1, wherein the thickness of the protuberances is varied to provide varied regions of flexibility along the protuberances.

9. A fitting of claim 1, wherein (i) the inner end of each protuberance includes a reinforcing portion; (ii) each protuberance includes a window extending between the inner end and the outer edge, and a sloped portion extending towards the outer edge of each protuberance; (iii) the outer edge of each protuberance comprises an increased width relative to the inner end of each protuberance; (iv) the inner end of each protuberance includes a same width or an increased width relative to the width of the outer edge of each protuberance; (v) each protuberance includes a narrow portion between the inner end and the outer edge; (vi) each protuberance comprises a recess or notch disposed between the inner end and the outer edge; or (vii) each outer edge of the protuberance is configured to reduce tissue damage when in contact with the tissue.

10. A fitting of claim 1, wherein (i) the protuberances are biased to a rest position and movable at least between a first position when the medical scoping device is being advanced distally into a biological lumen and a second position when the medical scoping device is being withdrawn proximally from the biological lumen, and when in the rest position the protuberances are angled relative to a longitudinal axis of the fitting; or (ii) the fitting is disposable.

11. A fitting of claim 10, wherein (i) the protuberances when in the first position further comprise a transparent or semi-transparent cylindrical member extending from a distal end of the fitting; or (ii) the protuberances are movable radially inward relative to the body when the medical scoping device is being advanced distally into a biological lumen and the

protuberances are movable radially outwardly relative to the body to engage tissue when the medical scoping device is being advanced proximally from the biological lumen.

12. A fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an interior having an opening to receive an endoscope along the longitudinal axis, the body having a first cylindrical portion and a second cylindrical portion separable from the first cylindrical portion, the first cylindrical portion comprising protuberances being spaced apart and circumferentially arrayed with respect to one another and extending from the first cylindrical portion, the second cylindrical portion comprising protuberances being spaced apart and circumferentially arrayed with respect to one another and extending from the second cylindrical portion, each of the protuberances having an inner end and an outer edge to engage tissue, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance.

13. A fitting of claim 12, wherein the protuberances of the first cylindrical portion are arranged into a first row, the protuberances of the second cylindrical portion are arranged into a second row, and the first and second rows are staggered with respect to one another.

14. A fitting of claim 13, wherein (i) the protuberances of the first row comprise a length from the inner end to the outer edge that is greater than a length of the protuberances of the second row; or (ii) the protuberances of the first row are biased at an angle greater than an angle of the protuberances of the second row.

15. A fitting of claim 12, wherein (i) each protuberance includes an area of a first degree of flexibility at the inner end and at the outer edge and an area of a second degree of flexibility in a middle portion between the inner end and the outer edge, the second degree of flexibility being greater than the first degree of flexibility; or (ii) each protuberance comprises a middle portion having a recess that increases flexibility of the outer edge relative to the inner end of each protuberance.

16. A fitting of claim 12, wherein the first cylindrical portion is configured to retain the second cylindrical portion, the first cylindrical portion including at least one locking member to engage an inner surface of the second cylindrical portion.

17. A fitting of claim 12, wherein the thickness of the protuberances is varied to provide varied regions of flexibility along the protuberances.

18. A fitting of claim 12, wherein (i) the inner end of each protuberance includes a reinforcing portion; (ii) each protuberance includes a window extending between the inner end and the outer edge and a sloped portion extending towards the outer edge of each protuberance; (iii) the outer edge of each protuberance comprises an increased width relative to the inner end of each protuberance; (iv) the inner end of each protuberance includes a same width or an increased width relative to the outer edge of each protuberance; (v) each protuberance includes a narrow portion between the inner end and the outer edge; (vi) each protuberance comprises a recess or notch disposed between the inner end and the outer edge; or (vii) each outer edge of the protuberance is contoured so as to reduce tissue damage when in contact with the tissue.

19. A fitting of claim 12, wherein (i) the protuberances when in the first position further comprise a transparent or semi-transparent cylindrical member extending from a distal end of the fitting; or (ii) the protuberances are movable radially inward relative to the body when the medical scoping device is being advanced distally into a biological lumen and the protuberances are movable radially outwardly relative to the body to engage tissue when the medical scoping device is being advanced proximally from the biological lumen.

20. A fitting of claim 12, further comprising a transparent or semi-transparent cylindrical member extending from a distal end of the fitting.

21. A fitting of claim 12, wherein the fitting is disposable.

22. A method of performing an endoscopy, the method comprising disposing an endoscope cap on a distal end of an endoscope, the cap comprising a body defining a

longitudinal axis, the body having first and second regions, and an interior having an opening to receive the endoscope along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the endoscope, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance; and inserting the distal end of the endoscope into a biological lumen to move the protuberances radially inward relative to the body of the cap; and moving the endoscope proximally in the biological lumen for a distance to move the protuberances radially outward relative to the body of the cap.

23. A method of claim 22, wherein when the protuberances are radially inward relative to the body of the cap, the protuberances are in a compressed configuration and when the protuberances are radially outward relative to the body of the cap, the protuberances contact folds in the biological lumen.

24. A method of making a fitting for a medical scoping device of claim 1, the method comprising adding a thermoplastic material to a mold and forming the fitting.

25. A kit for performing an endoscopy, the kit comprising a disposable endoscope cap, the cap having a body defining a longitudinal axis, the body having first and second regions, and an interior having an opening to receive an endoscope along the longitudinal axis, each of the first and second regions of the body comprising protuberances, each protuberance having an inner end and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the cap, wherein each protuberance has varying flexibility from the inner end to the outer edge of each protuberance; and a sterilized packaging configured to provide an airtight seal for the cap.

26. A fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein the middle portion comprises a recess that increases flexibility of the outer edge relative to the inner end of each protuberance.

27. A fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein (i) the inner end of each protuberance has the same or increased width or surface area relative to the outer edge of each protuberance and the middle portion has a decreased width or surface area relative to the width of the inner end or outer edge of the protuberance; (ii) the inner end of each protuberance has a reinforced region having increased thickness relative to the thickness of the middle portion and the outer edge of the protuberance; or (iii) the inner end of each protuberance has decreased width or surface area relative to the outer edge of each protuberance.

28. A fitting for an endoscope of claim 25, wherein the body has an arc length of 360 degrees and the protuberances have a total arc length of less than 360 degrees to allow debris from a colon wall to pass by the fitting when passed through the colon.

29. A fitting for an endoscope, the fitting comprising a body defining a longitudinal axis, the body having an exterior surface, and an interior having an opening to receive the endoscope along the longitudinal axis, the exterior surface of the body comprising protuberances, each protuberance having an inner end, a middle portion, and an outer edge to engage tissue, each protuberance being spaced apart and circumferentially arrayed with respect to one another and extending from the body of the fitting, wherein the outer edge of each protuberance comprises a raised surface configured to engage tissue, wherein said engagement causes a change in shape of the fitting.