The present invention relates to a method and apparatus for compressing and providing support to the abdominal wall to facilitate a colonoscopic examination.
A colonoscopy is 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 as a screening tool to detect colorectal cancer has increased significantly since 2000.
During a colonoscopy, 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 has been addressed by utilizing a surgical technician to manually support the patient's colon with pressure. This is time-consuming and dependent on the particular surgical assistant's strength, technique, and endurance, as well as training. Another way to apply differential pressure, particularly in larger patients, is to roll the patient from the left side to a supine or to a prone position. Often this is not an easy task with a sedated patient.
Devices and methods for addressing this problem are known in prior art. For example, the Klingstein U.S. Pat. No. 5,685,321 discloses a method and apparatus for applying external compression to the colon through the use of a corset-like wrap containing a pneumatic, inflatable bladder. The device is wrapped around the patient's abdomen and the bladder, once inflated, applies force to the patient's colon, particularly to the sigmoid colon, in order to facilitate the procedure.
The Rindfleish U.S. Pat. No. 6,672,311 discloses a vest including multiple pneumatic bladders that are selectively inflated by the doctor performing the colonoscopy in order to apply pressure to specific areas of the patient's abdomen.
The Arber U.S. patent application publication No. US 2011/0087263 A1 discloses an abdominal wrap including multiple pneumatic bladders and a counter pressure plate in order to provide downward pressure to a patient's large intestines when the device is inflated.
While the prior devices operate satisfactorily, they require the use of a pneumatic mechanism to apply force to the patient's abdomen. The present invention was developed in order to overcome this and other drawbacks of the prior devices by providing a device in which force and support are generated by tension created when the device is secured around the patient's abdomen. The pressure applied to the patient is the result of the tensile properties of the device and of the material of which the device is composed. Furthermore, the present invention is distinguished from the prior art in that its design purposefully allows a surgical technician to apply additional pressure by manually compressing the abdomen while the device applies simultaneous pressure.
Accordingly, it is a primary object of the invention to provide a method and apparatus for applying pressure to the abdomen of a patient to ease the passage of a colonoscope during a colonoscopy. More particularly, the invention relates to a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region, including the patient's colon, for the purpose of facilitating the advancement of the colonoscope during a colonoscopy.
In a preferred embodiment, the tensile colonoscopy compression device includes an abdominal wrap composed of a thin, flexible, breathable material capable of holding tension when the device is wrapped around a patient's abdomen. The wrap is fastened by a closing mechanism. The device can be between 30 to 70 inches in length and between 4 to 16 inches in width. In one preferred embodiment, the width is between 6 and 8 inches.
The device is formed of a material capable of holding tension in order to exert pressure and provide support to the patient's abdomen. In one embodiment, the material is formed of thin, braided elastic and nylon bands sewn together with a stretchable fiber. In alternative embodiments, the material is a soft, foam-like rubber or neoprene, a manufactured fabric with elastic properties, or a flexible synthetic plastic or vinyl. The material could be disposable in nature, or classified as a medical consumable, in which case the device will be used on only one patient and then discarded.
The closing mechanism is preferably a combination of hook and pyle straps such as a VELCRO® material which are removably and adjustably connected. Other suitable closing mechanisms include a hinged closure, with a hinge on one end of the device through which the other end of the device is passed. The end of the device passed through the hinge has a VELCRO® material patch that adheres to any part of the device. Once this end of the device is passed through the hinge, it is looped back over and fastened.
The tensile colonoscopy compression device according to the invention preferably includes a thin plastic or paper liner that is attached to the inside of the device with fasteners, and rests between the patient's body and the device.
In yet another aspect, the invention relates to a method for compressing and supporting a patient's colon during a colonoscopy. The compression device is applied to the patient prior to sedation, thereby allowing the patient to provide the doctor with feedback regarding his or her comfort level and obviating the risk of over-compression. If greater pressure is needed after the patient has been sedated and the procedure has begun, the doctor may instruct a surgical technician to manually apply location-specific pressure through the device given its thin construction.
Other objects and advantages of the present invention will become apparent from a study of the following specification when viewed in the light of the accompanying drawing, in which:
Referring first to
The tensile colonoscopy compression device 8 according to the invention is used to apply pressure and support to the abdomen of a patient undergoing a colonoscopy is shown in
The tensile wrap 10 preferably has a circumferential length between 15 and 75 inches in order to accommodate varying abdominal girths in patients. The preferred width of the wrap 10 is between 6 and 9 inches, although widths of between 4 and 16 inches may be used depending on the size of the patient. Because the tensile wrap 10 is used to generate pressure upon the patient's abdomen, it is preferred that the wrap be constructed of a material with elastic properties that is capable of holding tension. The degree of elasticity of the wrap will vary in accordance with the material used for the band. The wrap may be formed from a single band or composed of several bands of woven, elastic nylon fabric 14, each approximately 3 inches wide and spaced approximately 0.2 inches apart from one another as shown in
In the preferred embodiment, the closing mechanism 12 is a VELCRO® fastener including a pile pad 18 sewn onto one end of the wrap 10 and a hooked strip 20 sewn onto the other end of the wrap 10. The pad and strip are both of generally the same width as the wrap. The pad has a length of about six inches and the strip has a length of about two inches. To fasten the wrap 10, the pad 18 is pulled over top and pressed into the strip 20, which secures the two ends of the wrap 10 together.
Other types of closing mechanisms may be provided, including for example a hinged clamp, a strap and buckle arrangement, or a strap and loop arrangement. In addition, where the wrap is formed of a woven material, the closing mechanism may comprise a hooked portion connected at one end of the wrap. The wrap is wound about a patient's abdomen with the hooked end overlapping the wrap and fastening directly to the woven material of the wrap. It is important that the closing mechanism be adjustable in order to vary the pressure and support provided to the patient as will be developed in greater detail below.
In use, the tensile colonoscopy compression device 8 according to the invention is applied to the patient as shown in
The tensile colonoscopy compression device 8 is applied to the patient before the patient is sedated so that the patient is able to provide feedback to the doctor regarding his or her level of comfort as the tension of the device 8 is adjusted. The patient is advised that the device 8 should exert pressure to the abdomen, but that at no time should it cause discomfort.
Once the device 8 is secured around the patient's lower abdomen at the desired level of tension, sedative medication is then delivered through the patient's IV and the patient is rolled into a left lateral position for the insertion of the colonoscope. Referring to
Even with the tensile colonoscopy compression device in place, a more proximal loop may form in the colon, for instance in the left or right upper quadrants (the splenic or the hepatic flexures) as shown in
In the preferred embodiment, once the colonoscope reaches the patient's cecum and abdominal compression is no longer needed, the tensile colonoscopy compression device 8 is released with a simple pull upon the top side of the closing mechanism 12 and the patient's colon is then examined as the scope is slowly withdrawn.
It will be appreciated that other suitable elastic materials may be used in place of nylon to form the wrap or band. Suitable alternatives include soft, foam-like rubber or neoprene, a manufactured fabric with elastic properties, or a flexible synthetic plastic or vinyl. The device may include a removable liner (not shown) which is arranged between the band and the patient. The liner is replaced for subsequent use of the compression device on other patients. Alternatively, the elastic material could be disposable in nature, or classified as a medical consumable, in which case the device will be used on only one patient and then discarded.
While the preferred forms and embodiments of the invention have been illustrated and described be apparent to those of ordinary skill in the art that various changes and modifications may be made without deviating from the inventive concepts set forth above.
This application is a Continuation of U.S. patent application Ser. No. 13/344,715, now U.S. Pat. No. 9,724,225, filed Jan. 6, 2012. The disclosure of the priority application is incorporated in its entirety herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3115879 | Kaplan | Dec 1963 | A |
3120846 | Fletcher | Feb 1964 | A |
3554190 | Kaplan | Jan 1971 | A |
3902503 | Gaylord, Jr. | Sep 1975 | A |
4833730 | Nelson | May 1989 | A |
4991234 | Greenberg | Feb 1991 | A |
5188585 | Peters | Feb 1993 | A |
5685321 | Klingenstein | Nov 1997 | A |
5885230 | Cherry | Mar 1999 | A |
6672311 | Rindfleish | Jan 2004 | B2 |
8066657 | Frazer | Nov 2011 | B2 |
20020108617 | Burton | Aug 2002 | A1 |
20110087263 | Arber | Apr 2011 | A1 |
Number | Date | Country |
---|---|---|
202161367 | Mar 2012 | CN |
2 381 732 | May 2003 | GB |
3051938 | Jun 1998 | JP |
2005-021113 | Jan 2005 | JP |
2006-314711 | Nov 2006 | JP |
200264387 | Feb 2002 | KR |
WO 9508308 | Mar 1995 | WO |
WO 9614811 | May 1996 | WO |
WO 9746180 | Dec 1997 | WO |
Entry |
---|
European Search Report dated Sep. 2, 2015; Application No. 12864172.7. |
Soper, N. J., et al., Chapter 45: Flexible Endoscopy of the Lower Gastrointestinal Tract, Endoscopic and Laparoscopic Surgery, Lippincott Williams & Wilkins, Philadelphia, PA, pp. 451, 2009. |
First Office Action issued in Canadian Patent Application No. 2,869,162 based upon International Patent Application No. PCT/US2012/068492 dated Sep. 26, 2018. |
Number | Date | Country | |
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20170296374 A1 | Oct 2017 | US |
Number | Date | Country | |
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Parent | 13344715 | Jan 2012 | US |
Child | 15637529 | US |