Endoscopic band with visual indicator for assisting configuration

Abstract

An endoscopy support device including a primary wrap sized for placement around a subject's lower abdomen, at least one elastic strap extending from the primary wrap, extending across at least a portion of the primary wrap, and fastened to a third portion of the primary wrap and configured to adjust the amount of pressure applied by the endoscopy support device, and the endoscopy support device including at least one visual indicator provided on the primary wrap or the at least one elastic strap indicating placement of the endoscopy support device on the subject or adjustment of the at least one elastic strap.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 978,797, filed on February 19, 2020, entitled "Endoscopy Band With Visual Indicator to Assist Placement", the content of which is hereby expressly incorporated by reference in its entirety.

Background Art

[0002] Colonoscopy is an examination of the large intestine or colon using a colonoscope. A colonoscope is a flexible, tube - shaped examination device with a camera at its tip. Colonoscopy is performed for various medical reasons, including the discovery of inflamed tissue, ulcers, abnormal growths or polyps, and colorectal cancer. Colonoscopy is increasingly being used as a screening tool for detecting colorectal cancer.

[0003] During colonoscopy, a colonoscope is inserted into the patient's rectum and advanced to the beginning of the colon (the area known as the cecum) to examine the inner wall of the large intestine. The efficiency and accuracy of this procedure depend greatly on how easily the colonoscope can be advanced. During the procedure, the colon can become overly inflated or oriented in unnatural directions, forming loops that impede the advancement of the colonoscope, potentially causing patient discomfort, extended examination times, and potentially inaccurate or incomplete screening.

[0004] Currently, the difficulty of advancing the scope is addressed by the technician applying manual pressure to support the patient's colon by hand. Applying manual pressure is time - consuming and varies depending on the strength, technique, endurance, and training of a particular technician. To apply differential pressure, the technician may roll the patient from the left side into a supine or prone position, which can be a difficult task for a sedated patient. Supporting the patient's colon and applying manual pressure and moving the patient during the procedure places a physical burden on the technician.

Summary of the Invention

[0005] In one aspect of the present disclosure, a method and apparatus for applying pressure to a patient's abdomen are provided to facilitate the passage of an endoscope during procedures used to examine the intestine, including colonoscopy, sigmoidoscopy, and enteroscopy. The aspects presented herein prevent and reduce intestinal looping, eliminate the need for manual pressure application, improve patient safety, comfort, and satisfaction, and prevent musculoskeletal injury to endoscopic healthcare providers by applying both a wide-ranging uniform lower abdominal pressure and additional position-specific pressure to the sigmoid colon.

[0006] Aspects include a primary wrap sized for placement around the lower abdomen of a subject and at least one secondary strap extending from the primary wrap, extending across at least a portion of the primary wrap, and configured to be fastened to a third portion of the primary wrap to adjust the amount of pressure applied by the endoscopic support device. Visual guides are provided on the primary wrap and / or at least one secondary strap to provide visual assistance to the technician when appropriately positioning the device relative to the patient and when adjusting focused support using the secondary strap.

[0007] Additional advantages and novel features of aspects of the present invention will be in part apparent from the following description, and in part will become more apparent to those skilled in the art by study of the following or by practice of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0008]

Figure 1A

Figure 1B

Figure 1C

Figure 2

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Figure 6

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DETAILED DESCRIPTION OF THE INVENTION

[0009] The detailed description set forth below in connection with the accompanying drawings is intended as a description of various configurations and is not intended to represent the only configuration in which the concepts described herein can be implemented. The detailed description includes specific details for the purpose of providing a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details.

[0010] Aspects presented herein include a primary abdominal wrap that is secured around the patient's lower abdomen and a secondary strap that provides a directed force and support to the sigmoid colon. Once the device is firmly secured, the secondary strap can be adjusted to function as a focused support or "splint" for the sigmoid colon. The device further includes a visual guide or indicator that provides visual reference marks and guidance for positioning the device on the patient and / or for adjusting the directed force using the secondary strap.

[0011] Figures 1A - 1C illustrate a series of steps of a colonoscopy. In Figure 1A, a colonoscope 2 is inserted into the patient's rectum and advanced through the length of the colon. As the operator passes the colonoscope through the sigmoid region of the colon 4, the colonoscope can cause collisions and anatomical distension and looping as shown in Figure 1B. This distension causes discomfort to the patient and increases the time required for the colonoscopy. To reduce the distended or looped region, the technician can apply manual pressure to the patient's abdomen. Among other examples, the technician may be a nurse, an assistant, or other staff. For example, the pressure may be applied by a nurse or a surgical assistant as shown in Figure 1C.

[0012] Applying pressure by hand is time-consuming and places a physical burden on the technician. The effectiveness of hand pressure varies depending on the strength, skill, endurance, and training of a particular technician. To apply differential pressure, the technician may roll the patient from the left side into a supine or prone position, which can be a difficult task for a sedated patient. Between treatment sites, applying pressure by hand and moving the patient to support the patient's colon and advance the colonoscope can even lead to injury to the technician.

[0013] Many patients undergo colonoscopy while lying on their left side in a stretcher or operating table. Additional information regarding the use of such hand pressure can be found in Prechel JA, Hucke R. Safe and effective abdominal pressure during colonoscopy: forearm versus open hand technique. Gastroenterol Nurs 2009;32:27-30; quiz 31-2, the entire content of which is incorporated herein by reference. When applying hand pressure, the technician may reach across the patient from the opposite side of the operating table, place the hand on the patient's sigmoid colon to distribute the pressure, and then lean backward using body weight as a lever to exert force. These methods are generally effective in generating pressure but have been identified as a cause of the high incidence of work-related injuries among endoscopy nurses and staff. Physicians performing colonoscopy are similarly at a particularly high risk of musculoskeletal work-related injuries. The most frequently injured site for physicians is the right upper extremity, which experiences peak torque forces when attempting to advance the scope through the (looped) sigmoid colon. Additional details can be found in Spanarkel M, Hathorn JP. Looping During Colonoscopy: A Major, Implied Cause of Injury Among Endoscopy Healthcare Providers and a Proposed Solution, 2013, the entire content of which is incorporated herein by reference.

[0014] Aspects described herein may be similarly applicable to other endoscopic procedures such as sigmoidoscopy and retrograde enteroscopy procedures. Sigmoidoscopy examines only the lower part of the colon from the anus to the descending colon. The endoscope is inserted into the lower part of the large intestine. Enteroscopy is an examination of the small intestine. During retrograde enteroscopy, the endoscope is inserted into the anus, passed through the large intestine and cecum, and advanced to the small intestine. Successfully navigating the sigmoid colon region, which is prone to looping, is necessary to complete both sigmoidoscopy and retrograde enteroscopy. Thus, the aspects described herein can be used to assist in facilitating colonoscopy, sigmoidoscopy, retrograde enteroscopy, and other endoscopic procedures.

[0015] FIG. 2 shows an exemplary device including a primary elongate band or wrap 10 of sufficient length to be disposed around a patient's lower abdomen. A closure mechanism 12 may be provided at the ends of the primary band to secure the device around the patient to provide a desired amount of broad support and compression. To assist in fastening and closing, a handle 14 may be stitched outside one or both ends of the primary wrap. FIG. 5 shows a portion of an exemplary wrap 10 having a handle 502 provided at the end of the wrap 10. The handle can be used by a technician to extend the wrap and apply a desired degree of compression when securing the primary wrap 10 around the patient.

[0016] The primary wrap 10 can have a circumferential length between about 15 and 75 inches to accommodate various abdominal circumferences of patients. The width of the primary wrap 10 can be between 6 and 10 inches, but depending on the patient's size and to accommodate special situations such as abdominal hernias or large pannus, a variant with a width between 3 and 20 inches may be used. For example, the primary wrap may be configured to have a width that allows it to be fastened around the lower abdomen of the patient such that the upper edge of the wrap is just below or near the navel and the lower edge of the wrap is along or near the pubic line. The width of the primary wrap can be selected so as not to be so large as to conceal the navel and additional areas of the abdomen above the navel. This configuration may be made to avoid compression of the diaphragm or the stomach, as during a colonoscopy, compression of the diaphragm and the stomach can increase the risk of hypoxia and aspiration events, respectively, due to the patient generally being in a sedated state during the procedure. The primary wrap 10 can wholly or partially include a flexible biocompatible foam, rubber, neoprene, polyester, nylon, non-woven or woven fabric, mesh fabric, synthetic fabric, microfiber fabric, silicon or vinyl plastic, or any other material generally known to be used in medical fabrics and articles. The primary wrap 10 may be composed of both elastic and non-elastic materials. In one example, the primary wrap 10 may include a plurality of laminated layers. For example, the primary wrap 10 may include a neoprene layer and an outer fabric layer laminated on the neoprene layer. The fabric layer may enable a secondary strap to be removably fastened along the length of the primary wrap and may also enable a visual indicator to be printed on a fabric such as nylon loop fabric. The primary wrap may also include an inner layer laminated on the neoprene. The inner layer may include a fabric or other material selected for skin sensitivity. For example, the inner layer may include a latex-free, biocompatible, and / or skin-sensitive fabric or other material. The inner layer may be the layer applied to the patient's skin.In some embodiments, the primary wrap may include a 3D spacer fabric that can provide compressive, elastic, cushioning, breathable, air permeable, heat insulating, temperature regulating, flexibility resistant to bending / curling, good draping, adjustable vapor transport, excellent aging quality, surface and laundering resistance, sterilization ability, and diverse surface design capabilities. The 3D spacer fabric may include an artificial textile structure in which two fabric layers are connected by a layer of pile yarns, which may also be called pile yarns.

[0017] The primary wrap may include two or more sections of different material types. In one example, a first set of one or more sections may be composed of a flexible, elastic or semi-elastic, medium-thick, latex-free neoprene with thin polyester or nylon adhered to its inner and outer sides. In particular, this material may be capable of providing extensive, firm and yet comfortable support to the patient's abdominal region. Another set of one or more sections of the primary wrap 10 may include a relatively inelastic material such as a woven fabric. The inelastic section may be provided at a position where the insert is disposed therein or at a position where the insert is disposed thereunder. When the device is deployed, the inelastic section may be positioned over the sigmoid colon in the patient's left lower abdomen.

[0018] In order for the primary wrap to provide appropriate overall compression and support, it may be important for the wrap to remain flat against the body when fastened around the abdomen. This is noted because certain materials and designs tend to roll up when stretched or wrapped around the abdomen, especially when the device is applied to patients with large pannus. To prevent the occurrence of roll-up, embodiments of the present invention may include a reinforcing material to ensure that the primary abdominal wrap remains flat against the body when used on patients of various body sizes. This can be achieved by applying a serge stitch along the edge of the primary abdominal band.

[0019] The primary wrap may also accommodate an insert or attachment that provides specific support to one or more regions of the colon, including the sigmoid colon, transverse colon, and colonic regions, as well as the spleen and hepatic flexure. Once the device is firmly secured, the secondary strap, insert, or both can be pushed, pulled, or otherwise inserted against the body in a manner that supports or "props up" one or more regions of the colon, including the sigmoid colon, transverse colon, and colonic regions, as well as the spleen and hepatic flexure. The aspects described herein can be designed to provide broad lower abdominal support and additional direct force to one or more regions of the colon, including the sigmoid colon, transverse colon, and colonic regions, as well as the spleen and hepatic flexure, of a patient undergoing a colonoscopy.

[0020] The primary wrap 10 may be positioned around the patient's lower abdomen and secured using a closure mechanism 12 consisting of a strip of VELCRO® or hook material 13 disposed on the inside of the wrap 10 near the location of the opposite handle 14. This hook strip 13 may be fastened to the outer side of the opposite end of the primary wrap 10.

[0021] The edge of the hook strip 13 may not extend to the edge of the primary wrap 10. This configuration may be designed to minimize the chance that the hook strip 13 contacts the patient's skin or the glove of a nurse or assistant deploying the device, as there is a small but known risk that VELCRO®, or hook and loop material, can tear a medical glove.

[0022] Additional features designed to reduce the likelihood of patient and provider contact with the hook material. In an embodiment incorporating this feature, a thin layer of material can be applied to the hook strip incorporated into the device before the device is packaged. This layer can include, for example, paper, plastic, cloth, silicon, or any other biocompatible material typically used in healthcare products. Further, this layer can be lightly adhered to the hook strip so that it remains in place until it is easily removed and discarded by the end user immediately prior to application of the device to the patient. This feature can be useful in the use of the secondary strap 72. This is because it can be useful for the secondary strap 72 to remain unfastened until the primary wrap 10 is fastened and properly positioned. Having a layer covering the hook strip 75 of the secondary strap 72 helps ensure that the secondary strap is not accidentally fastened while the user is securing the primary wrap 10 around the patient's abdomen.

[0023] Adding one or more appendages to the outside of the primary wrap, for example, makes it easier to apply additional directional forces without the need to adjust the primary wrap. The appendage may include one or more straps attached on one side to one or more edges of the inelastic section. FIGS. 2-4 show an example with a single secondary strap. FIG. 8 shows an example with multiple secondary straps 72a, 72b. At the unattached ends of these straps, there may be a closure mechanism, such as 74a, 74b. The closure mechanism may include a handle or loop near the end of the strap, which can provide greater ease or additional safety for the technician when pulling the elastic strap to apply the targeted additional compression. Straps 72a, 72b may be pulled horizontally along the outside of the primary wrap and fastened using a closure mechanism safely enough to maintain tension. One or more straps may include an elastic material configured to be stretched and fastened to the primary wrap to apply the targeted compression by elastic contraction of the material. The amount of targeted compression may be adjusted via the adjustment of the position where the removable end is coupled to the primary wrap, such as via a Velcro fastener. In some examples, the straps may be fixed to the inelastic section of the primary wrap, and the tension created by fastening these straps may cause additional compression of the inelastic section and / or insert towards the patient's body.

[0024] As depicted in FIG. 4, the secondary strap 72 can enable nurses and technicians to easily adjust and readjust the forces on specific areas of the patient's abdomen, such as the sigmoid colon and / or transverse colon, from the positions in the treatment room or operating room that these staff typically occupy, in relation to how the patient is often positioned during an endoscopic procedure. The endoscopic compression device described herein further eliminates the need for a nurse or assistant to manually apply abdominal compression, thereby reducing the risk of musculoskeletal injury. Additional, manual compression may be applied in conjunction with the compression from the device. This device is designed to be quickly and easily removable when the need arises.

[0025] The secondary strap 72 may be coupled, e.g., sewn, to a wrap portion configured to be disposed over the left side of the patient's lower abdomen. The portion of the secondary strap 72 that is coupled to the primary wrap may be referred to as a fixed end and may be non-removably coupled to the strap, e.g., sewn or formed as an extension of the primary wrap material. The strap may be configured to extend across the lower abdomen and / or left lower abdomen from the left side to the right side of the patient's body, e.g., to be pulled from left to right. This arrangement of the secondary strap 72 may allow for easy adjustment of the compression when the patient is lying on their left side during the procedure. When the strap is pulled from left to right across the lower abdomen, additional leverage and compression may be generated by the patient's body when the strap is in place. Since the strap extends from left to right across the patient's abdomen, the level of compression generated by the device can be easily adjusted during the procedure, e.g., while the patient is lying on their left side.

[0026] In some embodiments, the fixed end of the strap 72 may be connected to the wrap 10 such that the fixed end of the strap is under the patient during the procedure.

[0027] As shown in FIGS. 2-4, the device may include a primary wrap 10 having a closure mechanism 12 and at least one handle 14 that aids in securing a primary wrap around the patient's lower abdomen. The device may also include a secondary strap 72 attached to an outer side surface 78 of the primary wrap 10, the secondary strap 72 having a closure mechanism 74 that enables the strap to be secured, for example, to the outer side surface 78 of the primary wrap 10. In one aspect, the closure mechanism 74 of the secondary strap 72 may include an inner hook strip 75 of the secondary strap 72 that can be secured anywhere along the outer side surface 78 of the primary wrap 10. In this example, the outer side surface 78 of the primary wrap 10 may include a hook-compatible material that can secure the hook strip 75 and remain secured while the secondary strap is extended and under tension. The secondary strap 72 may be composed of an elastic or semi-elastic material that extends horizontally and can hold tension when secured to the outer side surface 78 of the primary wrap 10 using the closure mechanism 74. The secondary strap 72 may include the same material as the material included in the primary wrap 10 or a different material. The secondary strap 72 may include one or more material layers. In one example, the secondary strap 72 may include an elastic strap whose overall length is equal to approximately twice the intended length of the secondary strap 72. As shown, the secondary strap may be tapered along the length of the strap 72. In the example of FIGS. 2-4, the elastic strap may be doubled over, and both ends may be sewn to the outside 78 of the primary wrap 10 along the same vertical line 73, creating a horizontal "V" appearance of the secondary strap 72. Doubling the material that makes up the secondary strap serves to increase the width and force generated by the secondary strap while preventing the occurrence of additional material costs associated with using, instead, a tall single-layer strap. The midpoint of the secondary strap may be positioned to extend substantially beyond the patient's left lower abdomen when it is extended and secured. In other examples, such as those shown in FIGS. 5, 6, and 8, the secondary strap 72 may be a one-piece component having at least one tapered edge.

[0028] FIG. 6 shows an example in which a visual guide 60 may be provided on the secondary strap 72 to assist in adjusting the targeted compression or splinting by the secondary strap. The first indicator 62 may indicate the direction in which the secondary strap may be pulled to apply concentrated compression to the transverse colon. The indicator 62 may include an image such as an arrow indicating the direction in which the secondary strap 72 is extended, pulled, or moved to apply concentrated compression to the transverse colon. The indicator 62 may include characters identifying the area of compression or characters providing additional assistance when applying concentrated compression. In FIG. 6, the indicator 62 includes an arrow and the character "transverse" that simply shows the technician an easy way to extend the secondary strap across the patient's abdomen and secure it to the primary wrap 10 to apply concentrated pressure to the transverse colon. More than one indicator may be provided. For example, FIG. 6 shows a second indicator 64 indicating a different direction in which the secondary strap may be pulled to apply concentrated compression to the sigmoid colon. The indicator 64 may include an image and / or characters, similar to the indicator 62. The indicators 62 and 64 in FIG. 6 are merely examples for illustrative purposes, and other images or character descriptions may also be used. Although specific examples of the indicators 62 and 64 for adjusting the targeted compression or splinting of the transverse colon and / or sigmoid colon have been provided, indicators may be provided that provide visual images and / or descriptions to assist in positioning the secondary strap 72 to apply compression to other areas involved in endoscopic procedures, such as the splenic flexure, hepatic flexure, etc.

[0029] As described above, a plurality of secondary straps may be provided on the device. FIG. 8 shows an example where indicators 62 and 64 are provided on different secondary straps. For example, the device may include two secondary straps as shown in FIG. 8. The first elastic strap 72b may extend from the primary wrap in a left-to-right direction to apply a targeted compression to the first abdominal region of the subject (e.g., the sigmoid colon region). The second elastic strap may extend from the primary wrap in a left-to-right direction for the application of a targeted compression to the second abdominal region of the subject. The primary wrap may include an upper edge for placement relative to the subject's umbilical line (e.g., as indicated by 172) and a lower edge for placement below the subject's umbilical line. The first elastic strap and the second elastic strap may extend from the primary wrap at the same position along the length of the primary wrap. For example, the two secondary straps may be sewn (or otherwise fastened or extended) from the same position along the length of the strap. The first strap may be positioned below the second strap along the width of the primary wrap. For example, as shown in FIG. 8, the first elastic strap may extend from a first position along the width of the primary wrap, and the second elastic strap may extend from a second position along the width of the primary wrap, and the second position is closer to the upper edge than the first position. By using a plurality of secondary straps, the user can simultaneously apply targeted compressions to different abdominal regions, e.g., different regions of the colon (such as the sigmoid and / or transverse regions), during the endoscopic procedure. Similarly, having a plurality of secondary straps allows adjustment of the targeted compression to one abdominal region while maintaining the targeted compression of the other abdominal region. For example, the technician may apply the targeted compression using the first and second straps. During the endoscopic procedure, the technician may adjust the first strap without removing or readjusting the second strap.

[0030] Figure 7 shows an example where a visual guide or indicator may be provided on the primary wrap 10 to assist in the placement of the primary wrap on the patient. Figure 7 shows a portion of the primary wrap 10 on the side configured for placement on the patient, e.g., the inner side surface of the wrap 10 which may be referred to as the inner side. In Figure 7, the first indicator 172 provides a visual indicator to the technician that the correct placement of the device for assisting in the endoscopic procedure involves aligning the upper edge of the primary wrap 10 with the patient's umbilical line. The indicator 172 may include an image such as one or more arrows indicating the edge of the wrap 10 that is to be aligned with the patient's umbilical line, and / or may include text explaining the alignment to the technician. For example, in Figure 7, the text indicates "Align upper edge with umbilical line". The exemplary indicator 172 of Figure 7 is merely an example for explaining the concept, and other images or textual descriptions may be used to provide guidance regarding the placement of the primary wrap on the patient. Figure 7 also shows an indicator 174 that provides guidance regarding the placement of the primary wrap 10 on the patient such that the secondary strap is in a position to provide targeted compression on the sigmoid colon, transverse colon, etc. The indicator 174 may include an image such as one or more arrows indicating the portion of the wrap 10 that is to be aligned with the patient's left hip joint, and / or may include text explaining the alignment to the technician. For example, in Figure 7, the text indicates "Green line above left hip joint". The visual indicator may be used in combination with a visual indicator at the end of the secondary strap 172 that is fixed to the opposite side of the primary wrap 10. As shown in Figure 7, the stitch 176 that secures the end of the secondary strap may use a color contrast to the primary wrap 10 such that the stitch provides a visual reference for the placement of that section of the primary wrap relative to the patient's left hip joint. The exemplary indicator 174 of Figure 7 is merely an example for explaining the concept, and other images or textual descriptions may be used to provide guidance regarding the placement of the primary wrap on the patient.

[0031] A mechanism indicating extension and compression, such as those described in relation thereto, may be provided, so that the device includes a mechanism for visually indicating the magnitude of the applied force, such as a mark 80 displayed as "Logo" that extends and deforms when the secondary strap 72 is extended and fastened. With this mechanism, the user can compare the deformed mark with the photos and illustrations included in the product manual or package to determine whether the device has been applied correctly.

[0032] FIG. 10 shows an additional view of device 1000 including a primary wrap and two elastic secondary straps 72a and 72b. FIG. 10 shows that each of secondary straps 72a and 72b may have a tapered shape and may include a double elastic layer, a folded-back design, similar to the single strap 72 shown in FIG. 4. Alternatively, the two elastic secondary straps 72 and 72b may have a single elastic layer design, such as that shown for the single strap in FIG. 5. FIG. 10 shows an example where each elastic strap 72a and 72b may include visual indicators that show and / or describe the direction of stretch to apply compression to multiple abdominal regions of the patient, similar to the example for the single strap shown in FIG. 6. For example, the first strap 72a may include a first indicator 62a that shows the direction to apply targeted compression to the transverse colon region and a second indicator 64a that shows the direction to apply targeted compression to the sigmoid colon region. Similarly, the second strap 72b may include a first indicator 62b that shows the direction to apply targeted compression to the transverse colon region and a second indicator 64b that shows the direction to apply targeted compression to the sigmoid colon region. FIG. 10 also shows stitches 1004a and 1004b that indicate the placement for Velcro fasteners at the movable ends of the two straps 72a, 72b. The closure mechanisms 74a, 74b may correspond to handles that allow the technician to more easily stretch and fasten the elastic straps 72a, 72b. In some embodiments, the Velcro fastener may be provided on the inner side surface of the edge 1008 of the primary wrap and may be configured for the outer side surface of the opposite end 1010 of the primary wrap. Thus, the end 1010 may be wrapped under the edge 1008 to fasten the primary wrap. The handle 502 may be provided on a portion of the primary wrap near the end 1010 and may be used for the technician to further pull the end 1010 under the edge 1008 to apply a higher level of primary compression through the elastic compression of the primary wrap 10. The visual indicator 1002 may indicate the upper edge of the wrap to assist with the orientation of the placement on the patient's abdomen.

[0033] Figure 11 shows an inner view 1100 of the side of the primary wrap 10, configured, for example, to be placed on a patient. In addition to the visual indicator 1002, the primary wrap 10 may further include a visual indicator indicating the lower or bottom side / edge of the wrap. The top / bottom indicator may help to avoid applying the primary wrap in the opposite direction. If the bottom edge is applied above the top edge, the secondary straps 72a, 72b may extend in the opposite direction and may not provide the targeted compression to the appropriate area of the patient's abdomen. Further, a visual indicator 1104 may be provided to indicate the correct placement along the width of the primary band. In the example of Figure 11, a line is provided as a visual indicator with respect to the patient's left hip joint. The indicator may further include one or more arrows and text. Although the example of Figure 11 uses a green line, the concept can also be applied to indicators of different colors, dashed lines, double lines, visual markers different from lines, etc. The visual indicator may help the technician to properly place the primary wrap on the patient so that the secondary strap is in the appropriate position to apply targeted compression to a specific area of the abdomen, such as the sigmoid colon area or the transverse colon area. Figure 12 shows an outer view 1200 of a part of the primary wrap, indicating that a visual indicator 1202 may be provided on the outside of the wrap. In Figure 12, the visual indicator 1202 assists the technician in placing the primary wrap having its top edge near the line of the umbilicus. The visual indicator may be arranged to align with the anterior abdominal region of the primary wrap when the wrap is properly placed (e.g., according to the visual indicator inside the primary wrap), and may enable the technician to view, for example, the alignment of the visual indicator with respect to the patient's umbilicus before or when fastening the closure of the primary wrap. Figure 12 also shows that the straps 72a, 72b may be coupled to the primary wrap at the same position along the length of the primary wrap 10. For example, Figure 12 shows the stitches 1204 attaching the fixed ends of the straps 72a, 72b to the primary wrap 10.

[0034] In some examples, one vertical side of the secondary strap may be fixed to the primary wrap, and the other side may be removably fastened to the primary wrap, such as via a Velcro closure. In other examples, the secondary strap 72 may be completely removable from the primary wrap and may have fastening mechanisms at both ends that allow the strap to be secured to the outer side surface of the primary wrap. The secondary strap in this aspect may be reusable or disposable, may be stretchable and maintain tension when secured to the primary band, or may use another mechanism to exert a compressive force. The straps in this example may not be completely wrapped around the patient, but instead may be directly stretched around the location on the patient's body where force is desired. The straps may have fastening mechanisms at both ends, for example, so that the straps can be attached directly to the patient's body.

[0035] It is very important to improve patient comfort and reduce complications both during and after an endoscopic procedure. The aspects presented herein reduce patient discomfort and complications by helping to prevent and reduce sigmoid colon looping, which can be a major cause of patient pain and discomfort.

[0036] When changing into a hospital gown or other clothing typically worn during an endoscopic procedure, patients often become cold or uncomfortably chilled. Many patients request and are provided with blankets, and some facilities provide electric heated blankets or pre-warmed blankets. Heated blankets not only provide physical warmth but also tend to relax patients and relieve anxiety or discomfort that patients may experience. The aspects presented herein may also help patients feel warm and comfortable during the procedure.

[0037] The devices shown in FIGS. 10-12 may include any of the additional aspects described in connection with FIGS. 1-8.

[0038] Figure 9 shows aspects of a method for applying pressure and support to a patient's abdomen during advancement of an endoscope during an endoscopic type of procedure.

[0039] At 902, the method includes wrapping a primary wrap around the patient's abdomen between the patient's hip joint and umbilicus, as described in connection with FIGS. 2 - 4. The primary wrap may include any of the aspects described in connection with FIGS. 1 - 8 and / or 10 - 12.

[0040] At 904, the method includes securing the primary wrap by attaching a first end of the primary wrap to a second portion of the primary wrap after wrapping the primary wrap around the patient's abdomen.

[0041] At 906, the method includes adjusting the compression applied to the patient's abdomen by pulling at least one strap extending from the primary wrap across at least a portion of the primary wrap and securing the strap to at least a third portion of the primary wrap, as illustrated in FIG. 4. The at least one strap may include any of the aspects described in connection with FIGS. 1 - 8 and / or 10 - 12. The amount of compression applied to the patient's abdomen may be adjusted at 906 by pulling the strap extending from the primary wrap across at least a portion of the primary wrap and securing the strap to the primary wrap. The strap may be coupled to a portion of the primary wrap configured to be positioned over the left side of the subject's lower abdomen. Thereby, the subject's own body weight can be utilized to adjust the compression provided by the strap. The strap may be pulled in a direction towards the right side of the subject's lower abdomen and may be configured to adjust the amount of pressure applied by an endoscopic support device. A combination of visual indicators may enable correct placement of the device on the patient and assist in applying a targeted compression through adjustment of at least one strap. The at least one visual indicator may include any of the aspects described in connection with FIGS. 1 - 8 and / or 10 - 12.

[0042] At least one visual indicator is used to place the primary wrap against the patient's abdomen and / or extend the strap. The at least one visual indicator may include a visual indication in the direction of extending at least one elastic band to apply an additional targeted force to the subject's sigmoid colon region as described in connection with the examples of FIGS. 6 and 8. The visual indication may include an arrow indicating the direction and / or a character indicating the sigmoid colon region. Thus, at 906, the method may include adjusting the strap to apply a targeted force to the subject's sigmoid colon using the visual indication.

[0043] The at least one visual indicator may include a visual indication in the direction of extending at least one elastic band to apply an additional targeted force to the subject's transverse colon region as described in connection with the examples of FIGS. 6 and 8. The visual indication may include an arrow indicating the direction and / or a character indicating the transverse colon region. Thus, at 906, the method may include adjusting the strap to apply a targeted force to the subject's transverse colon using the visual indication.

[0044] The at least one visual indicator may include a visual indication on the primary wrap indicating the placement of the primary wrap against the subject's abdomen as described in connection with FIG. 7. Thus, at 902, the method may include placing the primary wrap against the subject's abdomen using the visual indication.

[0045] The visual indication may indicate that the edge extending the length of the primary wrap is placed on the subject's umbilical line as described in connection with FIG. 7. The visual indication may include an arrow indicating the edge of the wrap and / or characters indicating and explaining that it is for placing the edge on the subject's umbilical line. Thus, at 902, the method may include aligning and relatively placing the edge of the primary wrap on the subject's umbilical line using the visual indication.

[0046] At least one visual indication may include a visual indication on the primary wrap that indicates the placement of the primary wrap relative to the subject's left hip joint as described in connection with FIG. 7. For example, the visual indication may indicate the alignment of the fixed end of the secondary strap with the subject's left hip joint. The visual indication may include an arrow indicating the fixed end of the secondary strap, a contrasting stitch securing the fixed end of the secondary strap to the primary wrap, and / or text indicating and explaining that it is the placement relative to the subject's left hip joint. Thus, at 902, the method may include using the visual indication to position the edge of the primary wrap relative to the subject's left hip joint.

[0047] At 906, the compression may be adjusted for a plurality of target positions through the adjustment of more than one strap. For example, as described in connection with FIG. 8, the user may adjust the compression in the first abdominal region by stretching and securing the first elastic strap, and may adjust the compression in the second abdominal region by stretching and securing the second elastic strap. The plurality of elastic straps may include visual indicators indicating the direction of stretch to apply targeted compression to different regions of the colon, such as the sigmoid colon region and / or the transverse colon region. The use of a plurality of secondary straps allows for simultaneous targeted compression of different abdominal regions, such as different regions of the colon, during the endoscopic procedure.

[0048] To further enhance patient comfort, certain aspects of the present invention are designed to be single-use and remain in place on the patient during and / or after the procedure. For example, maintaining the compression applied by the device during the withdrawal phase of the procedure and while imaging is being performed may help improve the detection of adenomas. The device may be maintained on the patient to reduce common post-procedure complications such as a feeling of fullness and abdominal pain caused by the fullness. Fullness, also known as gas distension, occurs after an endoscopic procedure. This is because doctors often use compressed air or carbon dioxide to insufflate parts of the intestine that are difficult to observe or examine. By opening up the area with gas, more complete visualization is possible and the effectiveness of the procedure is enhanced. However, the gas remains in the patient's body until it is absorbed or expelled. Since absorption is a very inefficient process, expulsion is the main gas removal mechanism. Gas distension is a major post-procedure complication and a frequent complaint from patients. However, if the wrap described herein remains in place after the procedure, the lower abdominal compression generated by the device allows the intestine to expel the trapped gas more quickly by directing the excess gas towards the rectum. As a result, the severity and duration of post-procedure fullness and associated abdominal pain may be reduced.

[0049] U.S. Patent Application No. 15 / 256,019, filed on September 2, 2016, entitled "METHOD AND APPARATUS FOR ENHANCED VISUALIZATION DURING ENDOSCOPY"; U.S. Patent Application No. 13 / 344,715, filed on January 6, 2012, entitled "METHOD AND APPARATUS FOR TENSILE COLONOSCOPY COMPRESSION"; U.S. Patent Application No. 14 / 575,860, filed on December 18, 2014, entitled "ENDOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS"; U.S. Provisional Patent Application No. 61 / 917,469, filed on December 18, 2013, entitled "COLONOSCOPY BAND WITH SIGMOID SPLINT"; U.S. Provisional Patent Application No. 61 / 944,658, filed on February 26, 2014, entitled "ENDOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS"; U.S. Provisional Patent Application No. 62 / 214,747, filed on September 4, 2015, entitled "IMPROVED BOWEL STABILITY AND ENHANCED VISUALIZATION DURING ENDOSCOPY", the contents of each are hereby expressly incorporated by reference in their entirety.

[0050] Exemplary aspects of the invention have been described in accordance with the above advantages. It will be understood that these examples are merely illustrative of aspects of the invention. Many variations and modifications will be apparent to those skilled in the art.

[0051] It is understood that the specific order or hierarchy of steps in the disclosed process is an illustration of an exemplary approach. Based on design preferences, it is understood that the specific order or hierarchy of steps in a process may be reconfigured. Additionally, some steps may be combined or omitted. The appended method claims present the elements of the various steps in a sample order and are not intended to be limited to the specific order or hierarchy presented.

[0052] The foregoing description has been provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but rather the full scope consistent with the language of the claims should be accorded, where reference to an element in the singular is not intended to mean "only one" unless specifically so stated, but rather "one or more." The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise specified, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof" include any combination of A, B, and / or C and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof" may be A only, B only, C only, A and B, A and C, B and C, or A, B, and C, and any of these combinations may include one or more members of A, B, or C. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Further, what is disclosed herein is not intended to be dedicated to the public regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed as a means-plus-function unless the element is expressly recited using the phrase "means for."

Claims

Claim 1 An endoscopic examination support device, including a primary wrap comprising an elastic material band sized to be disposed around the lower abdomen of a subject, a closure mechanism provided at an end of the primary wrap and configured to fix the primary wrap around the abdomen of the subject by removably attaching the end of the primary wrap to a second portion of the primary wrap, at least one elastic strap having a first end fixed to the primary wrap and a second end including a coupling mechanism for removably coupling the second end to the primary wrap, the at least one elastic strap being configured to extend in a left-to-right direction across the anterior abdominal portion of the primary wrap to exert an additional targeted force on a part of the abdomen of the subject, at least one visual indicator provided on the primary wrap or the at least one elastic strap indicating one or more of the direction of placement of the endoscopic examination support device with respect to the subject or the adjustment of the at least one elastic strap for a targeted compression comprising an endoscopic examination support device. Claim 2 wherein the at least one elastic strap is a first elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to the sigmoid colon region of the subject, the at least one visual indicator including a first character label and a first arrow indicating a first direction for applying the targeted compression to the sigmoid colon region, a second elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to the transverse colon region of the subject, the at least one visual indicator including a second character label and a second arrow indicating a second direction for applying the targeted compression to the transverse colon region, wherein the first direction is different from the second direction, The endoscopic examination support device according to claim 1, comprising. **Claim 3**: At least one elastic strap is configured to place the first end at the left hip joint of the subject and to extend in a left-to-right direction across the anterior abdominal portion of the primary wrap to exert the additional target force between the first end and the second end of the at least one elastic strap, the additional target force being targeted at at least one of the sigmoid colon region or the transverse colon region of the subject's abdomen. The endoscopic examination support device according to claim 2. **Claim 4** wherein the primary wrap has an upper edge for placement relative to the umbilical line of the subject, and a lower edge for placement below the umbilical line of the subject and includes the first elastic strap and the second elastic strap extending from the primary wrap at the same position along the length of the primary wrap, the first elastic strap extending from a first position along the width of the primary wrap, the second elastic strap extending from a second position along the width of the primary wrap, the second position being closer to the upper edge than the first position, The endoscopic examination support device according to claim 2. **Claim 5**: The at least one visual indicator further includes one or more visual indicators on the primary wrap indicating at least one of an edge extending the length of the primary wrap disposed at the umbilical line of the subject, or the placement of the primary wrap aligned with the hip joint of the subject The endoscopic examination support device according to claim 2. **Claim 6**: The one or more visual indicators include one or more of a first character and a first arrow indicating the edge disposed at the umbilical line of the subject, or a contrasting stitch indicating the placement of the primary wrap aligned with the hip joint of the subject. The endoscopic examination support device according to claim 5. **Claim 7** The at least one visual indicator includes a visual indication in the direction of stretching the at least one elastic strap to apply the additional target force to the sigmoid colon region of the subject. The endoscopic examination support device according to claim 1. **Claim 8** The visual indication includes an arrow indicating the direction. The endoscopic examination support device according to claim 7. **Claim 9** The visual indication includes a character indicating the sigmoid colon region. The endoscopic examination support device according to claim 8. **Claim 10** The endoscopic examination support device according to claim 1, wherein the at least one visual indicator includes a visual indication in a direction to extend the at least one elastic strap to apply the additional target force to the transverse colon region of the subject.

11. The endoscopic examination support device according to claim 10, wherein the visual indication includes an arrow indicating the direction.

12. The endoscopic examination support device according to claim 10, wherein the visual indication includes characters indicating the transverse colon region.

13. The endoscopic examination support device according to claim 1, wherein the at least one visual indicator includes a visual indication on the primary wrap indicating the arrangement of the primary wrap with respect to the abdomen of the subject.

14. The endoscopic examination support device according to claim 13, wherein the visual indication includes characters and an arrow visually indicating to the user one edge extending the length of the primary wrap disposed on the umbilical line of the subject.

15. The endoscopic examination support device according to claim 1, wherein the at least one visual indicator includes a visual indication on the primary wrap indicating the arrangement of the primary wrap with respect to the hip joint of the subject.

16. The endoscopic examination support device according to claim 15, wherein the visual indication is provided on a first side surface of the primary wrap and indicates alignment of the first end of the at least one elastic strap fixed to a second side surface of the hip joint of the subject and the primary wrap.

17. The endoscopic examination support device according to claim 16, wherein the visual indication includes one or more of an arrow or characters indicating the first end of the at least one elastic strap.

18. The endoscopic examination support device according to claim 16, wherein the visual indication includes a contrasting stitch fixing the first end of the at least one elastic strap to the primary wrap.

19. The at least one visual indicator a first visual indication on a first side surface of the primary wrap including a first character and a first arrow visually indicating to the user one edge extending the length of the primary wrap disposed on the umbilical line of the subject; a second visual indication on a first side surface of the primary wrap including a second character and a line indicating alignment of the first end of the at least one elastic strap fixed to a second side surface of the hip joint of the subject and the primary wrap; A third visual indicator on a first elastic strap extending in a left-to-right direction from the primary wrap for applying the targeted compression to the sigmoid colon region, the third visual indicator including a third character and a second arrow indicating a first direction in which the first elastic strap extends for applying the targeted compression to the sigmoid colon region. A fourth visual indicator on a second elastic strap extending in a left-to-right direction from the primary wrap for applying the targeted compression to the transverse colon region, the fourth visual indicator including a fourth character and a third arrow indicating a second direction for applying the targeted compression to the transverse colon region, wherein the first direction is different from the second direction. The endoscopic examination support device according to claim 1, comprising the above.

20. The at least one elastic strap is A first elastic strap extending in a left-to-right direction from the primary wrap for applying the targeted compression to a first abdominal region of the subject, The first elastic strap is A first sigmoid colon character label and a first arrow indicating a first direction for applying the targeted compression to the sigmoid colon region via the first elastic strap, A first transverse colon character label and a second arrow indicating a second direction for applying the targeted compression to the transverse colon region via the first elastic strap Including a first elastic strap, A second elastic strap extending from the primary wrap extending in the left-to-right direction for applying the targeted compression to a second abdominal region of the subject, The second elastic strap is A second sigmoid colon character label and a third arrow indicating the first direction for applying the targeted compression to the sigmoid colon region via the second elastic strap, A second transverse colon character label and a fourth arrow indicating the second direction for applying the targeted compression to the transverse colon region via the second elastic strap Including a second elastic strap The endoscopic examination support device according to claim 1, comprising the above.

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