COMPRESSION WITH AN ENDOSCOPY BAND IN ENDOSCOPY PROCEDURES INCLUDING ENTEROSCOPY

INTRODUCTION

A colonoscopy is an example of an endoscopy procedure including an examination of the large intestine or colon through the use of a colonoscope. A colonoscope is a flexible, tube-like inspection device having a camera at its end. Colonoscopies are performed for a variety of medical reasons including detection of inflamed tissue, ulcers, abnormal growths or polyps, and colorectal cancer. Colonoscopy is increasingly used as a screening tool to detect colorectal cancer.

During a colonoscopy, as an example of an endoscopy procedure, a colonoscope is inserted into a patient's rectum and then advanced to the beginning of the colon (an area known as the cecum) in order to examine the lining of the large intestine. The efficiency and accuracy of this procedure is largely dependent on the ease with which the colonoscope can be advanced. During the procedure, the colon may become over-distended or flopped in unnatural directions creating loops that hinder the advancement of the colonoscope and resulting in patient discomfort, longer examination times, and potentially inaccurate or incomplete screenings.

Currently, the difficulty in advancing the scope is addressed by the application of manual pressure by a technician to manually support the patient's colon. The application of manual pressure is time-consuming and varies depending on the particular technician's strength, technique, endurance, and training. In order to apply differential pressure, the technician may roll the patient from the left side to a supine or to a prone position, which can be a difficult task with a sedated patient. The application of manual pressure and movement of the patient in order to support the patient's colon and advance the colonoscope during the procedure places a physical toll on the technician.

SUMMARY

In an aspect of the disclosure, a method and apparatus for applying pressure to the abdomen of a patient is provided to ease the passage of an endoscope during procedures used to examine the bowels including colonoscopy, sigmoidoscopy, and enteroscopy. Aspects presented herein exert both broad, uniform lower abdominal pressure as well as additional, location-specific pressure upon the sigmoid colon and/or small bowel to assist with the advancement, withdrawal, and/or visualization as part of an endoscopy, colonoscopy, sigmoidoscopy, or enteroscopy procedure. Aspects presented herein may assist in preventing and reducing intestinal looping, eliminating the need for the application of manual pressure, improving patient safety, comfort, and satisfaction, and preventing musculoskeletal injury to endoscopy healthcare providers. Aspects may improve visualization and/or withdrawal portions of the procedure.

Aspects include a primary wrap sized for placement around a subject's lower abdomen and at least one secondary strap extending from the primary wrap and configured to extend across at least a portion of the primary wrap and to fasten to a third portion of the primary wrap to adjust the amount of pressure applied by the endoscopy support apparatus.

Aspects include a method of applying pressure and support to a patient's abdomen during an endoscopy procedure including applying a primary wrap comprising a band of elastic material to an abdomen of a patient and maintaining tension in the band in order to apply constant pressure and the support to the patient's abdomen through a contraction of the primary wrap in connection with an advancement or a withdrawal of an endoscope during an endoscopic procedure. The method includes adjusting at least one of the primary wrap or at least one secondary strap extending from the primary wrap to adjust compression and support the advancement or the withdrawal of the endoscope through the contraction of the primary wrap and the at least one secondary strap.

Additional advantages and novel features of aspects of the present invention will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic view of a colon with an endoscope (also known as a colonoscope for colonoscopy procedures) partially inserted therein.

FIG. 1B is a schematic view of a colon in which a sigmoid loop has developed due to an attempt to advance the endoscope against an unsupported colon wall;

FIG. 1C is a schematic view of a colon showing the application of manual pressure to the colon to facilitate insertion of an endoscope.

FIG. 2 is an illustration of an unfastened endoscopy band device with an elastic secondary strap capable of retaining tension and exerting directed force to the colon, including the sigmoid, traverse, and cecal regions, stretched and fastened to the primary wrap.

FIG. 3 is a perspective view of the endoscopy band device depicted in FIG. 2 as it appears when applied to a patient, in accordance with aspects of the present invention.

FIG. 4 illustrates a method of use of an endoscopy band device with an elastic secondary strap capable of retaining tension and exerting directed force for an endoscopy procedure.

FIG. 5 is an illustration of a portion of an endoscopy band showing a tapered secondary strap.

FIG. 6 illustrates a portion of an endoscopy band including visual guides for adjusting directional force with the secondary strap.

FIG. 7 illustrates an interior of an endoscopy band including visual guides for placement of the band on a patient.

FIG. 8 illustrates an endoscopy band having multiple secondary straps with visual guides for adjusting directional force with the secondary straps.

FIG. 9 is a flowchart of an example method of use of an endoscopy band as described herein.

FIG. 10 illustrates an endoscopy band having multiple secondary straps with visual guides for adjusting directional force with the secondary straps.

FIG. 11 illustrates an endoscopy band having multiple secondary straps with visual guides for adjusting directional force with the secondary straps.

FIG. 12 illustrates an endoscopy band having multiple secondary straps with visual guides for adjusting directional force with the secondary straps.

FIG. 13 illustrates an example aspects of a small bowel.

FIG. 14 illustrates aspects of a double balloon enteroscopy procedure for which compression may be applied or adjusted through the compression wrap described herein.

FIG. 15 illustrates aspects of a single balloon enteroscopy procedure for which compression may be applied or adjusted through the compression wrap described herein.

FIG. 16 is a flowchart of an example method of use of an endoscopy band as described herein.

FIG. 17 is a flowchart of an example method of use of an endoscopy band as described herein.

DETAILED DESCRIPTION

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

Aspects presented herein comprise a primary abdominal wrap that is secured around the abdomen of the patient and a secondary strap that provides directed force and support to the sigmoid colon or small bowel. When the device is securely fastened, the secondary strap may be adjusted to serve as a focused support or ‘splint’ for the sigmoid colon or small bowel. The apparatus may further include visual guides or indicators that provide visual reference marks and guidance for placing the apparatus on a patient and/or for adjusting directed force using the secondary strap.

FIGS. 1A-1C, illustrate a sequence of steps of a colonoscopy, as one example of an endoscopy procedure. Other examples of endoscopy procedures are described in connection with FIGS. 13-15. In FIG. 1A, a colonoscope 2 is inserted into the patient's rectum and advanced forward through the length of the colon. As the operator passes the colonoscope through the sigmoid region of the colon 4, the colonoscope may become impinged and cause distention and looping of the anatomy, as shown in FIG. 1B. The distention causes discomfort to the patient and increases the time required for the colonoscopy. In order to reduce the distended or looped area, a technician may apply manual pressure to abdomen of the patient. Among other examples, the technician may be a nurse, assistant, or other staff member. For example, the pressure may be applied by a nurse or surgical assistant as shown in FIG. 1C.

The application of manual pressure is time-consuming and places a physical toll on the technician. The effectiveness of the manual pressure varies depending on the particular technician's strength, technique, endurance, and training. In order to apply differential pressure, the technician may roll the patient from the left side to a supine or to a prone position, which can be a difficult task with a sedated patient. The application of manual pressure and movement of the patient in order to support the patient's colon and advance the colonoscope during the procedure places may even lead to injury of the technician.

Many patients undergo colonoscopy while placed in the left lateral decubitus position on the stretcher or operating table. Additional information about the use of such manual pressure can be found in Prechel J A, 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 contents of which are incorporated herein by reference. In applying manual pressure, the technician may reach over the patient from the opposite side of the table and to deploy pressure by placing their hands against the patient's sigmoid colon and then leaning backwards, using their bodyweight for leverage to exert force. While these methods are generally effective at generating pressure, they have also been identified as a causative factor for the high rate of work-related injuries among endoscopy nurses and staff. Physicians performing colonoscopy suffer work-related musculoskeletal injury at a particularly high-rate as well. The most frequent site of physician injury is the right upper extremity which experiences peak torque forces when while operators are attempting to advance the scope through (a looping) 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 contents of which are incorporated herein by reference.

Aspects described herein may similarly be applied for other endoscopic procedures such as sigmoidoscopy and retrograde enteroscopy procedures. Sigmoidoscopy is an examination of only the lower part of the colon, from the anus to the descending colon. An endoscope is inserted into the lower part of the colon. Enteroscopy is an examination of the small bowel. During retrograde enteroscopy, an endoscope is inserted in the anus and passed through the colon and the cecum and into the small bowel. Successfully navigating the loop-prone sigmoid region is necessary to complete both sigmoidoscopy and retrograde enteroscopy and thus aspects described herein can be used to help facilitate colonoscopy, sigmoidoscopy, retrograde enteroscopy, and other endoscopic procedures.

The small bowel is part of the intestine between the stomach and the colon. FIG. 13 includes an illustration of the small bowel. The small bowel comprises three segments, the duodenum, the jejunum, and the ileum.

It may be difficult to advance an endoscope in order to visualize the patient's entire small bowel due to the length, tortuosity/redundancy of the small bowel.

Push enteroscopy is an antegrade technique in which a physician uses a particular endoscope that is introduced through the patient's mouth. The physician slowly advances the scope, pushing the scope using pressure, as far as possible in order to visual the small bowel. However, this only allows for visualization of a limited portion of the small bowel.

Techniques and technologies may attempt to allow for greater visualization. As examples, single balloon enteroscopy, double balloon enteroscopy, and spiral enteroscopy are designed to overcome the challenge of advancing the scope deep into the small bowel. The three techniques may be considered, or may be referred to as, ‘deep small bowel enteroscopy.’

Each of the techniques can be used via an antegrade approach or a retrograde approach. In an antegrade approach, the scope is introduced through the patient's mouth and is advanced through the stomach in order to visualize the small intestine. In a retrograde approach, the scope is introduced through the rectum and through the colon and cecum in order to visualize the small intestine.

The techniques involve iterative advancement of an endoscope and an endoscopic overtube both of which can be advanced/withdrawn independently of one another.

As an example of balloon assisted enteroscopy, a double balloon enteroscopy (DBE) system may include an endoscope with an 8.5 mm diameter and a 200 cm working length, a 145 cm soft overtube with an outer diameter of 12.2 mm, and a specifically designed pump (the overtube may be backloaded onto the scope, a soft latex balloon may be attached to the tip of the enteroscope. The balloon can be inflated and deflated using a pump through the air channel in the enteroscope. The flexible overtube also has a latex balloon at its tip that can be inflated and deflated. FIG. 13 illustrates an example of an example DBE endoscope.

The DBE can be performed either via the mouth (anterograde approach) or the anus (retrograde approach). The insertion route may be selected according to the estimated location of the suspected lesion(s). With an antegrade examination, the enteroscope may be advanced using repetitive cycles of balloon inflation/deflation and scope advancement. During one cycle of the procedure, the scope may be advanced until no further forward progress is made. The balloon on the tip of the scope may then be inflated, anchoring the small bowel. Once the small bowel is anchored by the enteroscope balloon, the balloon on the overtube may be deflated (having been inflated during the prior cycle) and advanced until it reaches the inflated balloon on the scope. The balloon at the end of the overtube may then be inflated, and with both balloons inflated, the scope and overtube may be gently withdrawn to remove loops and pleat the small bowel onto the overtube. The balloon on the scope may then be deflated, and the cycle may be repeated until the scope can no longer be advanced or the lesion of interest is reached. The procedure may be carried out in reverse during withdrawal of the scope.

FIG. 14 illustrates an example of a double balloon endoscopy procedure. As illustrated at 1, the endoscope may be inserted through the overtube. At 2, the endoscope balloon may be inflated. At 3, the overtube may be advanced along the endoscope, and the overtube balloon may be inflated. At 4, the endoscope balloon may be deflated, and at 5, the endoscope may be advanced farther into the intestine. At 6, the endoscope balloon may be deflated. At 7, the overtube may be advanced along the endoscope, and the overtube may be deflated. At 8, the endoscope and overtube may be pulled/moved/withdrawn in the opposite direction in order to straighten the path through the intestine. Then, at 9, the endoscope balloon may be deflated, and the endoscope may be advanced, again, farther into the intestine, similar to 1. The procedure may be repeated, or performed iteratively in order to allow visualization of different areas of the intestine.

The procedure may be similar, or the same, for retrograde examinations. In retrograde examinations, the cycles of the scope advancement and withdrawal may be carried out in the colon, as well as in the small bowel. The cycles of advancement may help to ensure that there is no colonic looping prior to intubation of the terminal ileum, in some aspects.

In a single balloon enteroscopy, a enteroscope having a 200 cm high-resolution enteroscope with a 2.8 mm working channel may be used, for example. As an example, the overtube may be 140 cm long with a 13.2 mm outer diameter. The overtube may be equipped with a silicone balloon at its tip, which can be inflated and deflated.

The technique for single balloon enteroscopy is similar to that used for double balloon enteroscopy. Like double balloon enteroscopy, single balloon enteroscopy may use an overtube with a distal balloon to aid with scope advancement through the small bowel. However, SBE uses the scope's flexible tip to anchor the scope, rather than a second balloon on the tip of the enteroscope shown in FIG. 14. Anchoring stabilizes the scope, permitting advancement of the overtube. The overtube balloon is then inflated, and the tip of the enteroscope is straightened. With the overtube balloon inflated, the scope and overtube can be withdrawn, pleating the small bowel onto the overtube. The enteroscope is then advanced. Like double balloon enteroscopy, the cycle of advancement and withdrawal may be repeated until the scope can no longer be advanced or the lesion of interest is reached

Spiral enteroscopy is an alternative to balloon-assisted enteroscopy for evaluation of the small bowel.

Spiral enteroscopy may use an overtube with a soft raised helix at its distal end. As an example, a118-cm overtube may be compatible with enteroscopes that are 200 cm long and between 9.1 and 9.5 mm in diameter (ie, the enteroscopes used for double balloon or single balloon enteroscopy, but not standard enteroscopes). The spirals on the overtube are either 4.5 mm (low profile) or 5.5 mm (standard profile) high. The overtube has a coupling device that affixes it to the scope, while permitting rotation of the overtube. By rotating the overtube clockwise, the small bowel may be pleated onto the overtube, and the enteroscope is advanced.

Table 1 illustrates example aspects of push enteroscopy and techniques for application of a band that applies elastic compression. Table 2 illustrates example aspects of antegrade double balloon enteroscopy, and Table 3 illustrates example aspects of retrograde double balloon enteroscopy with compression applied through a band. Table 4 illustrates example aspects of antegrade single balloon enteroscopy, and Table 5 illustrates example aspects of retrograde single balloon enteroscopy with compression applied through a band. The band may include aspects described in connection with any of FIGS. 1-12.

TABLE 1

Push Enteroscopy
Antegrade

Equipment:
Enteroscope or colonoscopes

Technique:
The endoscope is introduced through the

mouth and advanced into the small bowel as

far as possible until looping limits forward

progression. Torque and withdrawal are

performed to reduce loops, and the endoscope

is then re-advanced and the process is

repeated. If the endoscope cannot be advanced

further with these maneuvers, patient position

can be changed and abdominal pressure can be

applied. I

Compression Method:
1. Apply primary band (elastic

material capable of retaining

tension) to patient abdomen to

apply selected degree of

pressure to abdomen

2. Insert endoscope (enteroscope

or colonoscope) via patient’s

mouth

3. Advance scope in small bowel

as far as possible

4. During advancement, adjust

primary band and/or secondary

straps to reduce loops

Alternative method:
1. Insert endoscope (enteroscope

or colonoscope) via patient’s

mouth

2. Advance scope in small bowel

as far as possible

3. Once scope is advanced as far

as possible, apply primary

band

4. Attempt to advance farther

5. Adjust secondary bands

6. Attempt to advance farther

7. Continue to iteratively adjust

primary and secondary bands

and attempt to advance scope

farther

TABLE 2

Double-Balloon Enteroscopy
Antegrade

Equipment:
Enteroscope or colonoscopes & overtube

Balloons on distal end of scope and

overtube

Technique:
DBE uses a specially coupled enteroscope

and overtube apparatus with latex balloons

mounted on the distal ends of each

component. DBE is a 2-person procedure,

requiring an endoscopist and an assistant.

After the overtube is loaded onto the

enteroscope, a soft latex balloon is attached

to the tip of the enteroscope. The balloons

are deflated at the initiation of the

procedure. For the antegrade approach, the

endoscope and overtube are advanced to

the duodenum past the major papilla, and

the overtube balloon is inflated to maintain

a stable position. The enteroscope is then

advanced up to 40 cm distal to the

overtube tip, and its balloon is inflated to

anchor the enteroscope. The overtube

balloon is then deflated, and the overtube

is advanced toward the tip of the

enteroscope. The overtube balloon is then

reinflated such that the entire apparatus is

secured to the intestine with both balloons

inflated. The enteroscope-overtube

apparatus is then retracted simultaneously

in order to pleat the intestine along the

overtube/scope like an accordion. This

sequence is repeated, and the device is

advanced through the intestine in 40-cm

increments

Wrap-facilitated method of
1. Apply Compression wrap

performing antegrade
2. Insert enteroscope and overtube

double-balloon enteroscopy
via patient's mouth

3. Advance enteroscope and

overtube to duodenum past

major papillia

4. Inflate overtube balloon

5. Attempt to advance enteroscope

6. Adjust primary / secondary

bands to apply selected pressure

to facilitate advancement

7. Advance enteroscope

8. Inflate balloon on enteroscope

9. Deflate balloon on overtube

10. Attempt to advance overtube

11. Adjust primary / secondary

bands to facilitate advancement

12. Advance overtube

13. Inflate balloon on overtube

14. Adjust compression provided

by primary and second bands

15. Pull back on enteroscope and

overtube simultaneously to

reduce loops

16. Deflate enteroscope balloon

17. Adjust compression provided

by primary and second bands

18. Attempt to advance enteroscope

19. Continue to iteratively adjust

compression provided by

primary band and secondary

straps during/before/or after:

each attempt to advance either

the enteroscope or the overtube,

or during/before/after pulling

back on scope to reduce loops

during insertion, or during

withdrawal

Alternative method:
1. Get as far as possible into small

bowel using Double-balloon

method

2. Then apply primary band only

and/or primary and one or more

secondary bands

3. Attempt to advance even

further, using iterative double-

balloon method, while adjusting

compression delivered by

primary band and secondary

straps (as described above)

TABLE 3

Double-Balloon Enteroscopy
Retrograde

Equipment:
Enteroscope & overtube

Balloons on distal end of scope and

overtube

Technique:
The endoscope is introduced through the

rectum and advanced to the cecum either

directly or by using the previously

described push-pull technique. With the

overtube balloon inflated, the enteroscope

is advanced across the ileocecal valve and

its balloon inflated within the ileum. The

overtube is then advanced into the ileum

with its balloon deflated. Subsequently,

the advancement steps are identical to

those of the antegrade DBE technique

previously described.

Wrap-facilitated method of
1. Use wrap as described in prior

performing retrograde
art to mitigate looping and

double-balloon enteroscopy
facilitate advancement of

endoscope through colon to

ce cum

2.Once cecum is reached, inflate

overtube balloon

3. Attempt to advance

enteroscope across terminal

ileocecal valve into terminal

illieum

4. Adjust primary / secondary

bands to facilitate advancement

5. Advance enteroscope

6. Inflate balloon on enteroscope

7. Deflate balloon on overtube

8. Attempt to advance overtube

9. Adjust primary and/or

secondary band or bands to

facilitate advancement

10. Advance overtube

11. Continue to iteratively adjust

primary and secondary bands

and attempt to advance scope

farther into small bowel

Alternative method, in which wrap is
1. Insert enteroscope (and

applied after reaching the cecum:
overtube) via patient’s rectum

2. Advance scope to cecum

3. Apply primary and/or primary

and secondary bands

4. Inflate overtube balloon

5. Attempt to advance

enteroscope across terminal

ileocecal valve into terminal

illieum

6. Adjust primary / secondary

bands to facilitate advancement

7. Advance enteroscope

8. Inflate balloon on enteroscope

9. Deflate balloon on overtube

10. Attempt to advance overtube

11. Adjust primary and/or

secondary band or bands to

facilitate advancement

12. Advance overtube

13. Continue to iteratively adjust

primary and secondary bands

and attempt to advance scope

farther

In the example in Table 3, during the advancement of the endoscope through large intestine (colon)—e.g. colonoscopy—having two secondary straps may allow for the simultaneous targeting of two different areas of the colon. The areas may be any two areas of the abdomen/colon. In some aspects, the two areas may be the sigmoid and transverse colons, which are the two areas in which 90% of looping occurs.

In the case of retrograde deep enteroscopy into the small bowel, having multiple straps provides stability/looping mitigation in the large intestine to be achieved and maintained while the device provides additional, directed compression to help facilitate scope advancement in the small intestine.

TABLE 4

Single-Balloon Enteroscopy
Antegrade

Equipment:
Enteroscope and overtube

Balloon on distal end of overtube

Technique:
SBE it uses an enteroscope with an

overtube. In contrast to DBE, only the

overtube has a balloon at its distal end.

The technique for SBE is similar to that

for DBE. The overtube is backloaded onto

the enteroscope, and the enteroscope is

inserted through the patient’s mouth and

advanced as far as possible into the small

bowel, then anchored by using its flexible

tip (as opposed to enteroscope tip balloon-

assisted anchoring used in DBE).

Subsequently, the overtube is advanced

with its balloon deflated to the tip of the

enteroscope. The overtube balloon is then

inflated while keeping the enteroscope tip

flexed. The entire apparatus is then

withdrawn to allow pleating of the small

bowel over the enteroscope and overtube.

The enteroscope is then re-advanced

while keeping the overtube balloon

inflated to prevent slippage of the

proximal bowel that has been pleated on

the overtube. When the enteroscope

cannot be advanced further, its tip is again

flexed to anchor the enteroscope. The

overtube balloon is then deflated, and the

overtube is again advanced to the tip of

the enteroscope. This sequence is repeated

until the apparatus has advanced to the

maximal, or to the desired extent within

the small intestine.

Wrap Method:
i) Same iterative steps as

described above using

wrap/band with antegrade

DBE, but instead of inflating

balloon on end of scope, scope

tip is angulated to hold

position

Alternative method:
i) Get scope as far as possible

into small bowel using

antegrade single balloon

method

ii) Once scope is advanced as far

as possible, apply primary

band and/or primary band and

one or more secondary band(s)

iii) Same iterative steps as

described above using wrap

with antegrade DBE, but

instead of inflating balloon on

end of scope, scope tip is

angulated to hold position

TABLE 5

Single-Balloon Enteroscopy
Retrograde

Equipment:
Enteroscope and overtube

Balloon on distal end of overtube

Technique:
Same as description above for retrograde

DBE, just using SBE approach

Wrap Method:
ii) Same iterative steps described

above as using Wrap/Band

with antegrade DBE

Alternative method:
iv) Same iterative steps described

above as using Wrap/Band

alternative method with

antegrade DBE

Tables 1-5 illustrate example aspects in which the primary wrap and/or secondary bands of a compression device may be applied and/or adjusted at various points of the different procedures, e.g., as the scope is iteratively advanced deeper into the small bowel. The different levels of compression, presence/absence of compression, and/or targeted areas of compression may assist with the advancement of the scope, withdrawal of the scope, and/or visualization of the small bowel, colon, etc.

Compression with a band including any of the aspects described in connection with

FIGS. 1-12 may also be employed for spiral enteroscopy. For spiral enteroscopy, forward pressure may be applied to the enteroscope when rotation is started to advance or insert the scope. In some aspects, irrigation using a water get may assist with lumen visualization and lubrication, and intermittent abdominal compression and release may be provided by a compression wrap through release/adjustment of the secondary strap(s) and/or the primary wrap. In some aspects, consistent compression may be applied through some aspects of the advancement and/or withdrawal of the scope. Spiral enteroscopy relies on passive pleating and unpleating of the bowel, e.g., without forceful advancement or withdrawal of the scope. With an antegrade approach, the insertion proceeds through the stomach. A forward pressure during intubation of the pylorus may generate a gastric loop that may be reduced by straightening the enteroscope. In some aspects, a compression wrap may apply compression to assist in avoiding looping.

In an antegrade approach for spiral enteroscopy, the scope may be passed through the fixed ligament of Treitz. Deeper passage into the small bowel may be achieved with the lumen decompressed. In some aspects, compression may be applied or adjusted by a primary wrap and/or secondary band in order to assist insertion and/or advancement. Passage through the small bowel may be achieved with forward rotation of the spiral segment and gentle forward pressure on the enteroscope. The passage may be assisted by application or adjustment of the primary wrap and/or secondary band. In some aspects, sharply angled bends may be encountered, and abdominal compression may be applied, adjusted, or maintained over the area by the primary wrap and/or secondary strap(s) followed by gentle forward pressure on the enteroscope. The sequence of compression application/adjustment and forward pressure on the enteroscope may be repeated until the bend can be successfully traversed by the enteroscope.

In the retrograde approach for spiral enteroscopy, abdominal compression may be applied as needed, through application or adjustment of the primary wrap and/or secondary strap(s) in order to assist the spiral segment to be advanced across the value into the terminal ileum. Compression may also be applied or adjusted while passing through the small bowel in order to avoid looping and/or to address looping that does occur. The compression may be applied or adjusted for the area, and then the forward rotation of the spiral segment may be resumed.

FIG. 2 illustrates an example device including a primary elongated band or wrap 10 of sufficient length for placement around a patient's lower abdomen. A closing mechanism 12 may be provided at the end of the primary band to secure the device around the patient so that it provides the desired amount of broad support and compression. A handle 14 may be sewn onto the exterior of one or both ends of the primary wrap to assist in fastening and closure. FIG. 5 illustrates a portion of an example wrap 10 having handles 502 provided at an end of the wrap 10. The handles may be used by the technician to stretch the wrap and apply a desired degree of compression when fastening the primary wrap 10 around the patient.

The primary wrap 10 may have a circumferential length between approximately 15 and 75 inches in order to accommodate varying abdominal girths in patients. The width of the primary wrap 10 may be between 6 and 10 inches, although variations having widths of between 3 and 20 inches may be used depending on the size of the patient and to accommodate special circumstances such as an abdominal hernia or a large pannus. For example, the primary wrap may be configured to have a width that allows it to be fastened around the patient's lower abdomen with the upper edge of the wrap just below the umbilicus, or near the umbilicus, and the bottom edge of the wrap along or close to the pubic line. The width of the primary wrap may be selected so as not to be so large that the upper edge conceals the umbilicus and additional areas of the abdomen above the umbilicus. This configuration may be made in order to avoid pressure on the diaphragm or stomach, as pressure on the diaphragm and stomach during colonoscopy can increase the risk of oxygen deprivation and aspiration events, respectively, due to the fact that the patient is generally sedated during the procedure. The primary wrap 10 may comprise, entirely or in part, a flexible, bio-compatible foam, rubber, neoprene, polyester, nylon, non-woven or woven fabric, mesh fabric, synthetic fabric, microfiber fabric, silicon or vinyl plastic, or any other materials generally known to be used in medical fabrics and goods. The primary wrap 10 may be composed of both elastic and inelastic materials. In one example, the primary wrap 10 may comprise multiple layers laminated together. For example, the primary wrap 10 may comprise a neoprene layer and an outer fabric layer laminated on the neoprene layer. The fabric layer may enable the secondary strap to be removably fastened along the length of the primary wrap and may also enable visual indicators to be printed on the fabric, such as a nylon loop fabric. The primary wrap may also comprise an inner layer laminated on the neoprene. The inner layer may comprise a fabric or other material that is selected for skin sensitivity. For example, the inner layer may comprise a fabric or other material that is latex free, biocompatible, and/or skin sensitive. The inner layer may be the layer that is applied against the skin of the patient. In some aspects, the primary wrap may comprise 3D spacer fabrics, which may provide compression, elasticity, cushioning, breathability, air permeability, thermal insulation, temperature regulation, flexibility with resistance to bending/rolling, good draping, adjustable vapor transport, good aging qualities, surface and wash resistance, sterilization capabilities, and diverse surface design capabilities. A 3D spacer fabric may comprise a manufactured textile structure in which two fabric layers are connected by a layer of pile threads, which may be referred to as pile yarns.

The primary wrap may comprise two or more sections that vary in material type. In one example, a first set of one or more sections may be composed of a flexible, elastic or semi-elastic, medium-thickness, latex-free neoprene with thin polyester or nylon glued to its interior and exterior sides. Among others, this material may be capable of providing broad, firm, yet comfortable support to the patient's abdominal region. Another set of one or more sections of the primary wrap 10 may comprise a relatively inelastic material, such as a woven fabric. The inelastic section may be provided at the location into which or under which an insert is placed. Upon deployment of the device, the inelastic section may be positioned in the patient's lower left abdominal quadrant, over the sigmoid region.

For the primary wrap to provide appropriate general compression and support, it may be important that the wrap remain flat against the body when fastened around the abdomen. This is notable because certain materials and designs have a tendency to roll-up when stretched or wrapped around the abdomen, particularly when the device is being applied to patients with a large pannus. To prevent roll-up from occurring, aspects of the invention may include reinforcements to ensure that the primary abdominal wrap remains flat against the body when used in patients of varying body sizes. This may be accomplished by the application of serge stitching along the edges of the primary abdominal band.

The primary wrap may also accommodate an insert or attachment that provides specific support to one or more areas of the colon including the sigmoid, transverse, and cecal regions as well as the splenic and hepatic flexures. When the device is securely fastened, the secondary strap, the insert, or both, may be pushed, pulled, or otherwise pressed into the body in a manner that serves to support or ‘splint’ one or more areas of the colon including the sigmoid, transverse, and cecal regions as well as the splenic and hepatic flexures. Aspects described herein may be designed to provide broad lower abdominal support, and additional direct force to one or more areas of the colon including the sigmoid, transverse, and cecal regions as well as the splenic and hepatic flexures of a patient undergoing colonoscopy.

The primary wrap 10 may be placed around the patient's lower abdomen and secured using a closing mechanism 12 consisting of a strip of VELCRO® or hook material 13 placed on the interior of the wrap 10 close to the location of the handle 14 on the opposite side. This hook strip 13 may be fastened to the exterior side of the opposite end of the primary wrap 10.

The edges of the hook strip 13 might not extend to the edges of the primary wrap 10.

This construction may be designed to minimize the chance that the hook strip 13 comes into contact with the patient's skin, or with the gloves of the nurse or assistant deploying the device, as there is a small but known risk of VELCRO®, or a hook and pile material, being capable of tearing medical gloves.

An additional feature designed to reduce the likelihood of patient and provider contact with the hook material. In aspects incorporating this feature, prior to the device being packaged, a thin layer of material may be applied to hook strips that are incorporated into the device. This layer may comprise, e.g., paper, plastic, fabric, silicon, or any other biocompatible material typically used in healthcare products. Additionally, the layer may be lightly adhered to the hook strips so that it remains in place— until it is easily removed and disposed of by the end user just prior to the device's application on the patient. This feature may be helpful in use of a secondary strap 72, because it may be helpful 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 on the secondary strap 72 helps to ensure that the secondary strap will not be accidentally fastened while the user is securing the primary wrap 10 around the patient's abdomen.

The addition of one or more appendages on the exterior of the primary wrap facilitates the application of additional directed force, e.g., without requiring adjustment of the primary wrap. The appendages may comprise one, or multiple, straps attached on one side to the edge or edges of non-elastic section. FIGS. 2-4 illustrate an example with a single secondary strap. FIG. 8 illustrates an example having multiple secondary straps 72a, 72b. On the unattached end of these straps, there may be a closing mechanism, e.g., 74a, 74b. The closing mechanism may include a handle or loop near the end of the strap, that may provide greater ease to a technician, or added security, in pulling the elastic strap to apply targeted, additional compression. The straps 72a, 72b may be pulled horizontally along the exterior of the primary wrap, and fastened using the closing mechanism securely enough to maintain tension. The one or more straps may comprise an elastic material that is configured to be stretched and fastened to the primary wrap in order to apply targeted compression through elastic contraction of the material. The amount of targeted compression may be adjusted through adjustment of the position at which the removable end is coupled to the primary wrap, such as through a Velcro fastener. In some examples, the straps may be secured to an inelastic section of the primary wrap, and the tension generated by fastening these straps may cause additional compression of the inelastic section and/or an insert toward the body of the patient.

As depicted in FIG. 4, the secondary strap 72 may allow nurses and technicians to easily adjust and readjust the force on a particular region of the patient's abdomen, such as the sigmoid colon and/or the transverse colon, from the location in the procedure or operating room that these staff members typically occupy, relative to how patients are often positioned during an endoscopy procedure. The endoscopy compression device described herein additionally eliminates the need for the nurse or assistant to provide manual abdominal compression, thereby reducing their risk of musculoskeletal injury. Additional, manual compression may be applied along with compression from the device. The device is designed to be quickly and easily removed should the need arise.

The secondary strap 72 may be coupled, e.g., sewn, to a portion of the wrap that is configured for placement over a 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 the secured end and may be non-removably coupled to the strap, such as sewn or formed as an extension of the primary wrap material. The strap can be configured to be pulled from left to right, e.g., to stretch across the lower abdomen and/or left lower abdominal quadrant from the left side of the patient's body towards right side of the patient's body. This placement of the secondary strap 72 may enable the compression to be easily adjusted as the patient lies on their left side during the procedure. As the strap pulls 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. As the strap stretches from left to right cross the patient's abdomen, the level of compression generated by the device can easily be adjusted during the procedure, e.g., while the patient is lying on their left side.

In some aspects, the secured end of the strap 72 may be connected to the wrap 10 in a manner that the secured end of the strap is under the patient during a procedure.

As illustrated in FIGS. 2-4, the device may include a primary wrap 10, with a closing mechanism 12, and at least one handle 14 to assist in fastening the primary wrap around the patient's lower abdomen. The device may also include a secondary strap 72 attached to the exterior side 78 of the primary wrap 10, with a closing mechanism 74 that allows the strap, e.g., to be fastened to the exterior side 78 of the primary wrap 10. In an aspect, the closing mechanism 74 of the secondary strap 72 may comprise a hook strip 75 on the inside of the secondary strap 72 that is capable of fastening anywhere along the exterior side 78 of the primary wrap 10. In this example, the exterior side 78 of the primary wrap 10 may comprise a hook-compatible material to which the hook strip 75 can be fastened and remain fastened while the secondary strap is stretched and under tension. The secondary strap 72 may be constructed of an elastic or semi-elastic material that is capable of retaining tension when stretched horizontally and fastened to the exterior side 78 of the primary wrap 10 using the closing mechanism 74. The secondary strap 72 may comprise the same or different materials than the materials comprised in the primary wrap 10. The secondary strap 72 may comprise one or more layers of materials. In an example, the secondary strap 72 may comprise an elastic strap the entire length of which equals approximately twice the intended length of the secondary strap 72. As illustrated, the secondary strap may taper along a length of the strap 72. In the example in FIGS. 2-4, the elastic strap may be doubled-over, and both ends may be sewn to the exterior 78 of the primary wrap 10 along the same vertical line 73, creating the horizontal ‘V’ appearance of the secondary strap 72. Doubling-over the material composing the secondary strap can serve to increase the breadth and force generated by the secondary strap, while preventing the incurrence of additional materials costs that would be associated with using a taller, single-layered strap instead. The midpoint of the secondary strap may be positioned approximately over the patient's lower left quadrant once it is stretched and fastened. In other examples, such as shown in FIGS. 5, 6, and 8, the secondary strap 72 may be a unitary piece having at least one tapering edge.

FIG. 6 illustrates an example in which a visual guide 60 may be provided on the secondary strap 72 to assist adjustment of the targeted compression or splinting by the secondary strap. A first indicator 62 may indicate the direction in which the secondary strap may be pulled to apply focused compression on the transverse colon. The indicator 62 may include an image, such as an arrow, showing the direction in which the secondary strap 72 is to be stretched, pulled, or moved in order to apply focused pressure on the transverse colon. The indicator 62 may include text that identifies the area of compression or that provides additional assistance in applying the focused pressure. In FIG. 6, the indicator 62 includes an arrow and the text “transverse” that indicates in a simple manner to the technician the way in which the secondary strap is to stretched across the abdomen of the patient and secured to the primary wrap 10 in order to apply focused pressure to the transverse colon. More than one indicator may be provided. For example, FIG. 6 illustrates a second indicator 64 indicating a different direction in which the secondary strap may be pulled to apply focused compression to the sigmoid colon. The indicator 64 may include an image and/or text, similar to the indicator 62. The indicators 62 and 64 in FIG. 6 is merely an example to illustrate the concept, and other images or text description may also be used. Although specific examples have been provided for indicators 62 and 64 for adjustment of targeted compression or splinting of the transverse colon and/or the sigmoid color, indicator(s) may be provided that provide a visual image and/or description that assist in placing the secondary strap 72 to apply compression for other areas involved in an endoscopy procedure, such as the splenic flexure, the hepatic flexure, etc.

As described above, multiple secondary straps may be provided on the device. FIG.

8 illustrates an example on which the indicators 62 and 64 are provided on different secondary straps. For example, the device may include two secondary straps, as shown in FIG. 8. A first elastic strap 72 b may extend in the left to right direction from the primary wrap for application of targeted compression to a first abdominal region (e.g., a sigmoid region) of the subject. A second elastic strap may extend from the primary wrap extending in the left to right direction for the application of targeted compression to a second abdominal region of the subject. The primary wrap may include an upper edge for placement relative to an umbilical line of the subject (e.g., such as shown at 172) and a lower edge for placement below the umbilical line of the subject. The first elastic strap and the second elastic strap may extend from the primary wrap at a same position along the length of the primary wrap. For example, the two secondary straps may be sewn (or otherwise fastened or extending) from a same position along a length of the strap. The first strap may be positioned below the second strap along a width of the primary wrap. For example, as shown in FIG. 8, the first elastic strap may extend from a first position along a width of the primary wrap and the second elastic strap may extend 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 use of multiple secondary straps enables a user to simultaneously apply targeted compression of different abdominal areas, e.g., different regions of a colon (such as the sigmoid and/or transverse regions) during an endoscopy procedure. Similarly, having multiple secondary straps enables an adjustment of the targeted compression for one abdominal region while retaining the targeted compression of the other abdominal region. For example, the technician may apply targeted compression using the first and second strap. During an endoscopy procedure, the technician may adjust the first strap without removing or readjusting the second strap.

FIG. 7 illustrates an example in which a visual guide or indication may be provided on the primary wrap 10 to assist in placement of the primary wrap on the patient. FIG. 7 illustrates a portion of the primary wrap 10 on a side that is configured for placement against the patient, e.g., which may be referred to as an interior side of the wrap 10. In FIG. 7, a first indicator 172 provides a visual indication to the technician that the correct placement of the device, to assist with an endoscopy procedure, includes aligning the upper edge of the primary wrap 10 with an umbilical line of the patient. The indicator 172 may include an image, such as one or more arrows that show the edge of the wrap 10 to be aligned with the umbilical line of the patient and/or may include text describing the alignment to the technician. For example, in FIG. 7, the text indicates “Align upper edge with umbilical line.” The example indicator 172 in FIG. 7 is merely an example to illustrate the concept, and other images or text description may also be used to provide guidance about the placement of the primary wrap relative to the patient. FIG. 7 also illustrates an indicator 174 that provides guidance for placement of the primary wrap 10 on the patient so that the secondary strap is in a position to provide the targeted compression to the sigmoid colon, transverse colon, etc. The indicator 174 may include an image, such as one or more arrows that show the portion of the wrap 10 to be aligned with a left hip of the patient and/or may include text describing the alignment to the technician. For example, in FIG. 7, the text indicates “Green line on left hip.” The visual indicator may be used in combination with a visual indication of the end of the secondary strap 172 that is fixed to the opposite side of the primary wrap 10. As illustrated in FIG. 7, the stitching 176 that fixes the end of the secondary strap may use a contrasting color to the primary wrap 10 so that the stitching provides a visual reference for the placement of that section of the primary wrap relative to the left hip of the patient. The example indicator 174 in FIG. 7 is merely an example to illustrate the concept, and other images or text description may also be used to provide guidance about the placement of the primary wrap relative to the patient.

Mechanisms for indicating stretch and compression, such as those described in connection, may be provided so that the device includes a mechanism to visually indicate the magnitude of force being applied, such as the mark 80 labeled “Logo” which stretches and deforms when the secondary strap 72 is stretched and fastened. With this mechanism, users may compare the deformed mark with a picture or illustration included in the product instructions or packaging to determine that the device has been applied correctly.

FIG. 10 illustrates an additional view of a device 1000 including a primary wrap and two elastic secondary straps 72a and 72b. FIG. 10 illustrates that each of the secondary straps 72a and 72b may have a tapered shape and may include a double elastic layer, folded over design, similar to the single strap 72 illustrated in FIG. 4. Alternatively, the two elastic secondary straps 72 and 72b may have a single elastic layer design, such as illustrated for the single strap in FIG. 5. FIG. 10 illustrates an example in which each elastic strap 72a and 72b may include visual indicators showing and/or describing a direction of stretching to apply compression to multiple abdominal areas of a 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 showing a direction to apply targeted compression to a transverse colon region and a second indicator 64a showing a direction to apply targeted compression to a sigmoid colon region. Similarly, the second strap 72b may include a first indicator 62b showing a direction to apply targeted compression to a transverse colon region and a second indicator 64b showing a direction to apply targeted compression to a sigmoid colon region. FIG. 10 also illustrates stitching 1004a and 1004b, which indicates a placement for a Velcro fastener at the movable end of the two straps 72a, 72b. The closing mechanism 74a, 74b may correspond to a handle that enables the technician to stretch and fasten the elastic straps 72a, 72b more easily. In some aspects, a Velcro fastener may be provided at an interior side of the edge 1008 of the primary wrap, and may be configured to an exterior side of opposite end 1010 of the primary wrap. Thus, the end 1010 may be wrapped under the end 1008 in order to fasten the primary wrap. The handles 502 may be provided on a portion of the primary wrap that is closer to the end 1010, and may be used by a technician to pull the end 1010 further underneath the end 1008 in order to apply a higher level of primary compression through the elastic compression of the primary wrap 10. A visual indicator 1002 may indicate an upper edge of the wrap to assist the direction of placement against the abdomen of a patient.

FIG. 11 shows an interior view 1100 of a primary wrap 10, e.g., a side of the primary wrap that is configured for placement against the patient. In addition to the visual indicator 1002, the primary wrap 10 may further include a visual indicator that indicates a lower or bottom side/edge of the wrap. The top/bottom indicators may be helpful 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 will extend in the opposite direction and may not provide the targeted compression to the appropriate areas of the patient's abdomen. Additionally, a visual indicator 1104 may be provided to indicate correct placement along a width of the primary band. The example in FIG. 11 provides a line as a visual indicator with respect to the patient's left hip. The indicator may further include one or more arrows and text. Although the example in FIG. 11 uses a green line, the concepts may be applied for an indicator of a different color, a dashed line, a double line, a visual marker that is different than a line, etc.

The visual indicator may help a technician to properly place the primary wrap to the patient so that the secondary straps are in the appropriate location to apply targeted compression to particular areas of the abdomen, such as to a sigmoid colon region or to a transverse colon region. FIG. 12 illustrates an exterior view 1200 of a portion of the primary wrap and shows that a visual indicator 1202 may be provided on the exterior of the wrap. In FIG. 12, the visual indicator 1202 assists the technician in placing the primary wrap having the upper edge near the umbilical line. The visual indicator may be placed to line up with a front abdominal region of the primary wrap when the wrap is properly placed (e.g., following the visual indicators on the interior of the primary wrap) and may enable a technician to view the alignment of the visual indicator, e.g., relative to the patient's navel, before or at the time of fastening the closure of the primary wrap. FIG. 12 also illustrates that the straps 72a, 72b may be coupled to the primary wrap at a same position along a length of the primary wrap 10. For example, FIG. 12 illustrates stitching 1204 attaching the fixed end of the straps 72a, 72b to the primary wrap 10.

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 through a Velcro closure. In other examples, the secondary strap 72 may be fully detachable from the primary wrap, and may have fastening mechanisms at both ends that allow the strap to be secured the exterior side of the primary wrap. The secondary strap in this aspect may be either re-usable or disposable, and may be capable of being stretched and maintaining tension, or may use another mechanism to exert compressive force, when it is secured to the primary band. The strap in this example might not wrap fully around the patient but instead may be stretched directly about the location on the patient's body where force is desired. The strap may be equipped with fastening mechanisms on each end, e.g., to allow the strap to adhere directly to the patient's body.

Improving patient comfort and reducing complications, both during and following endoscopic procedures is very important. Aspects presented herein reduce patient discomfort and complications by helping to prevent and reduce sigmoid looping, which can be a primary cause of patient pain and discomfort.

Patients often become cold or uncomfortably chilled once they change into the garments such as hospital gowns typically worn while undergoing an endoscopic procedure. Many patients request and are provided with blankets, and some facilities provide electric heated blankets, or blankets that have been previously warmed. The heated blankets provide physical warmth, but also they tend to relax the patient and relieve anxiety or discomfort the patient may be experiencing. Aspects presented herein may also help the patient to feel warm and comfortable during the procedure.

The device illustrated in FIGS. 10-12 may include any of the additional aspects described in connection with FIGS. 1-8.

FIG. 9 illustrates aspects of a method for applying pressure and support to a patient's abdomen during advancement of an endoscope during an endoscopy type procedure. The endoscopy procedure may include any of a colonoscopy or a visualization of the small bowel. The method may include a double balloon endoscopy, a single balloon endoscopy, or a spiral enteroscopy. The procedure may be antegrade or retrograde. The method may include any of the aspects described in connection with Tables 1-5 or as further described herein.

At 902, the method includes wrapping a primary wrap about the abdomen of a patient between the hips and umbilicus of the patient, such 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.

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 about the abdomen of the patient.

At 906, the method includes adjusting compression applied to the abdomen of the patient by pulling at least one strap extending from the primary wrap across at least a portion of the primary wrap and to fasten the strap to at least a third portion of the primary wrap, such 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 abdomen of the patient may be adjusted by pulling a strap extending from the primary wrap across at least a portion of the primary wrap at 906 and fastening the strap to the primary wrap. The strap may be coupled to a portion of the primary wrap that is configured for placement over a left side of the subject's lower abdomen. This allows the patient's own body weight to be leveraged in order to adjust the compression provided by the strap. The strap may be configured to be pulled in a direction toward a right side of the subject's lower abdomen to adjust the amount of pressure applied by the endoscopy support apparatus.

The application and/or adjustment of the primary wrap or secondary strap(s) may be performed at particular points of the procedure to assist in passage of the scope.

The compression may be adjusted for multiple target locations through the adjustment of more than one strap. For example, as described in connection with FIG. 8, the user may adjust compression at a first abdominal region by stretching and fastening a first elastic strap and may adjust compression at a second abdominal region by stretching and fastening a second elastic strap. The multiple elastic straps may include visual indicators indicating a direction of stretching to apply targeted compression to different regions of a colon, e.g., to a sigmoid region and/or a transverse region. The use of multiple secondary straps enables simultaneous targeted compression of different abdominal areas, e.g., different regions of a colon during an endoscopy procedure.

As an example, FIG. 16 illustrates a method of applying pressure and support to a patient's abdomen during an endoscopy procedure, that may include aspects described in connection with FIG. 9. The method may include any of the aspects described in connection with Tables 1-5 or as further described herein. The endoscopy procedure may include an enteroscopy procedure. As an example, the endoscopy procedure may include at least one of a sigmoidoscopy, an enteroscopy, a single balloon enteroscopy, a double balloon enteroscopy, a spiral enteroscopy, a push enteroscopy, or an examination of a small bowel. In some aspects, the endoscopy procedure comprises an antegrade enteroscopy. In some aspects, the endoscopy procedure comprises a retrograde enteroscopy.

At 1602, a user applies a primary wrap comprising a band of elastic material to an abdomen of a patient. The primary wrap may include any of the aspects described in connection with FIGS. 1-8 and/or 10-12. FIG. 17 illustrates illustrates a method of applying pressure and support to a patient's abdomen during an endoscopy procedure that includes 1602 of FIG. 16. As shown in FIG. 17, in some aspects, the primary wrap may be applied prior to an introduction of the endoscope into the patient, e.g., at 1708 in FIG. 17. In some aspects, the primary wrap is applied following an introduction of the endoscope into the patient, e.g., at 1702 in FIG. 17. In some aspects, the primary wrap may be applied after advancement of the endoscope, e.g., based on a condition such as reaching a certain area of the patient, reaching an amount of resistance to advancement, etc.

At 1604, the user maintains tension in the band in order to apply constant pressure and the support to the patient's abdomen through a contraction of the primary wrap in connection with an advancement or a withdrawal of an endoscope during an endoscopic procedure.

The method may include adjusting compression applied to the abdomen of the patient by pulling at least one strap extending from the primary wrap across at least a portion of the primary wrap and to fasten the strap to at least a third portion of the primary wrap, such 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 abdomen of the patient may be adjusted by pulling a strap extending from the primary wrap across at least a portion of the primary wrap at 906 and fastening the strap to the primary wrap. The strap may be coupled to a portion of the primary wrap that is configured for placement over a left side of the subject's lower abdomen. This allows the patient's own body weight to be leveraged in order to adjust the compression provided by the strap. The strap may be configured to be pulled in a direction toward a right side of the subject's lower abdomen to adjust the amount of pressure applied by the endoscopy support apparatus.

At 1606, the user adjusts at least one of the primary wrap or at least one secondary strap extending from the primary wrap to adjust compression and support the advancement or the withdrawal of the endoscope through the contraction of the primary wrap and the at least one secondary strap. Adjusting the at least one of the primary wrap or the at least one secondary strap may include iteratively adjusting the at least one of the primary wrap or the at least one secondary strap in combination with, in correlation with, and/or triggered by, iterative advancement of the endoscope, e.g., as shown at 1714 in FIG. 17.

The application and/or adjustment of the primary wrap or secondary strap(s) may be performed at particular points of the procedure to assist in passage of the scope. The compression may be adjusted for multiple target locations through the adjustment of more than one strap. For example, as described in connection with FIG. 8, the user may adjust compression at a first abdominal region by stretching and fastening a first elastic strap and may adjust compression at a second abdominal region by stretching and fastening a second elastic strap. The multiple elastic straps may include visual indicators indicating a direction of stretching to apply targeted compression to different regions of a colon, e.g., to a sigmoid region and/or a transverse region. The use of multiple secondary straps enables simultaneous targeted compression of different abdominal areas, e.g., different regions of a colon during an endoscopy procedure.

For example, the user may adjust at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap in combination with iterative withdrawal of the endoscope. The user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with inflation or deflation of a balloon. The endoscope may comprise an enteroscope, and the user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement or a retraction of an overtube for the enteroscope. The endoscope may comprise an enteroscope, and the user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement of the enteroscope to a cecum. The endoscope may comprise an enteroscope, and the user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement of the enteroscope across a terminal ileocecal valve into a terminal illieum. The endoscope may comprise an enteroscope, and the user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with advancement of the enteroscope into a small bowel of the patient. The endoscope may comprise an enteroscope and the endoscopy procedure may comprise a spiral enteroscopy, and the user may adjust at least one of the primary wrap or the at least one secondary strap is performed in correlation with a passive pleating or unpleating of a bowel of the patient. The endoscope comprises an enteroscope, and the endoscopy procedure comprises a spiral enteroscopy, and the user adjusts at least one of the primary wrap or at least one elastic secondary strap is performed in correlation with a spiral rotation of the enteroscope. The adjustment of the compression may assist in the advancement of the endoscope, may prevent looping, may improve visualization, and/or may improve the ease and comfort of advancement or withdrawal of the endoscope.

In some aspects, such as illustrated at 1716, the user may maintain the compression with the primary wrap for a period of time following the withdrawal of the endoscope. The maintenance of the compression may reduce symptoms of bloating and abdominal pain by assisting with expulsion of gas introduced into the patient as part of the procedure.

To additionally enhance patient comfort, certain aspects of the invention are designed to be single-use, and to remain fastened in place on the patient during the procedure and/or following the procedure. For example, maintaining the compression applied by the device during the withdrawal phase of the procedure and while imaging is performed may help improve the detection of adenoma. The device may be maintain on the patient to reduce the common post-procedure complications of bloating and abdominal pain caused by bloating. Otherwise known as gaseous distention, bloating occurs following endoscopy procedures because physicians often use compressed air or carbon dioxide to insufflate parts of the bowel that are difficult to see and examine. The gas opens up the area to allow for a more complete visualization, enhancing the efficacy of the procedure. However, the gas also remains in the patient until it is either absorbed or expelled. Expulsion is the primary gas removal mechanism as absorption is a very inefficient process. Gaseous distention is a primary post-procedure complication and a frequent complaint from patients. However, when the wrap described herein remains in place after the procedure, the lower abdominal compression generated by the device allows the bowel to more rapidly evacuate trapped by directing excess gas towards the rectum. As a result, the severity and duration of post-procedure bloating and associated abdominal pain may be reduced.

The contents of each of U.S. application Ser. No. 15/256,019, entitled “METHOD AND APPARATUS FOR ENHANCED VISUALIZATION DURING ENDOSCOPY,” and filed on Sep. 2, 2016; U.S. application Ser. No. 13/344,715, entitled “METHOD AND APPARATUS FOR TENSILE COLONOSCOPY COMPRESSION,” and filed on Jan. 6, 2012; U.S. application Ser. No. 14/575,860, entitled “ENDOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS,” and filed on Dec. 18, 2014; U.S. Provisional Application Ser. No. 61/917,469, entitled “COLONOSCOPY BAND WITH SIGMOID SPLINT” and filed on Dec. 18, 2013; U.S. Provisional Application Ser. No. 61/944,658 entitled “ENDOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS” and filed on Feb. 26, 2014; U.S. Provisional Application No. 62/214,747, entitled “IMPROVED BOWEL STABILITY AND ENHANCED VISUALIZATION DURING ENDOSCOPY” and filed on Sep. 4, 2015, are expressly incorporated by reference herein in their entirety.

Example aspects of the present invention have now been described in accordance with the above advantages. It will be appreciated that these examples are merely illustrative of aspects of the present invention. Many variations and modifications will be apparent to those skilled in the art.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Further, some steps may be combined or omitted. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

The previous description is 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 generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” The word “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 specifically stated otherwise, 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,” and “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,” and “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 and B and C, where any such combinations may contain one or more member or 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 come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly 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.”

	Number	Date	Country
	62978797	Feb 2020	US
	63271156	Oct 2021	US

	Number	Date	Country
Parent	17180676	Feb 2021	US
Child	17972581		US

COMPRESSION WITH AN ENDOSCOPY BAND IN ENDOSCOPY PROCEDURES INCLUDING ENTEROSCOPY

Information

Publication Number

Date Filed

Date Published

Inventors

Original Assignees

CPC

International Classifications

Abstract

Description

Claims

CROSS REFERENCE TO RELATED APPLICATION(S)

Provisional Applications (2)

Continuation in Parts (1)