Patent Application
20230338176
No federal government funds were used in researching or developing this invention.
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The invention comprises a surgical method for restricting the size of a RYGBP patient's gastric outlet or “ostomy”, using existing in-market equipment as an alternative to TORe surgery, without the need for general anesthesia or an overnight hospital stay.
Morbid obesity in the US is currently at pandemic scale with over 50% of the population obese or morbidly obese. Obese individuals that have previously undergone bariatric bypass surgery, specifically, Roux-en-Y Gastric Bypass (RYGBP) and have regained the excess weight originally lost have few options other to repeat the surgery, resulting in unnecessary health risks and financial inefficiency.
Transoral outlet reduction (TORe) is a minimally invasive, endoscopic revision procedure that can help RYGBP patients who have regained weight. While gastric bypass limits the amount of food a patient can eat and produces a feeling of fullness, its effectiveness can diminish over time. TORe tightens the gastric outlet or “ostomy” with sutures to decrease the size of the opening.
Known devices exist for suturing around the RYGBP ostomy in hopes of reducing the outlet orifice opening, thus restricting flow, and caloric intake, resulting in weight loss. Such known devices are difficult to manage, require general anesthesia and requires expert endoscopic skills to operate and must generally be performed on an inpatient basis. Currently less that 100 physicians in the U.S. are performing TORe with the Apollo device mainly due to the restrictive nature of the required apparatus and the skill level involved.
What is needed is an alternative post-RYGBP procedure that will tighten the patient's ostomy, which can be performed by most or all U.S. gastroenterologists and requires neither general anesthesia nor an overnight hospital stay.
In a preferred embodiment, a surgical procedure for restricting flow through the ostomy of a RYGBP patient comprising the following steps:
In another preferred embodiment, the surgical procedure of as described herein, wherein the distal end of the grasping device comprises forceps/graspers embodied as a screw mechanism.
In another preferred embodiment, the surgical procedure of as described herein, wherein the turning motion of the tissue grasping device of step 4 comprises three turns and the unscrewing motion of step 5 also comprises three turns.
In another preferred embodiment, the surgical procedure of as described herein, wherein the endoscopic tissue grasping device grasps a tissue segment of 1-2 cm in length and pulls the tissue segment into the distal end of the banding device
In another preferred embodiment, the surgical procedure of as described herein, wherein the distal end of the gastroscopic banding device comprises a hollow piece that engages the tissue segment by overlaying the tissue segment.
In another preferred embodiment, the surgical procedure of as described herein, wherein the banding process of steps 4 and 5 is repeated four times, one for each quadrant around the ostomy orifice.
In another preferred embodiment, the surgical procedure of as described herein, further comprising step 9--Reintroducing endoscope to examine G-J anastomosis post therapy.
In another preferred embodiment, the surgical procedure of as described herein, wherein the cautery of step 3 is either BiCap or direct current cautery.
Gastroscopy, also known as upper endoscopy, involves using a thin flexible tube (endoscope or gastroscope) to examine the upper digestive tract. One type of gastroscopy, Esophagogastroduodenoscopy (EGD), is an endoscopic procedure that allows the doctor to examine the patient's esophagus, stomach and duodenum. EGD is an outpatient procedure and takes only 30 to 60 minutes to perform. It is considered a minimally invasive procedure since it does not require an incision into one of the major body cavities and does not require any significant recovery after the procedure.
The invention is a surgical method for restricting the size of a RYGBP patient's gastric outlet or “ostomy” (hereinafter, “TORe-B”). The TORe-B application of existing in-market equipment offers an alternative to TORe, with equal or better results, and can be performed by any gastroenterologist using the techniques learned in fellowship training across the specialty. Additionally, TORe-B does not require general anesthesia and can be performed in routine outpatient GI endoscopic facilities.
In particular, the inventive procedure requires only monitored anesthesia care (MAC) sedation. MAC anesthesia is a type of sedation where the patient remains calm, aware of his surroundings and able to follow instructions as needed. It is typically administered through an IV into the skin and muscle around the area on which the surgery is performed.
The surgical instruments required for a TORe-B procedure include, without limitation, a gastroscope, a BiCap or direct current cautery device, an endoscopic tissue grasping device and a gastroscopic banding device.
In particular, tissue grasping instruments are well known in the field of endoscopic surgery. Such instruments are typically embodied as a set of at least two retractable forceps, sometimes called claws or jaws, which are typically hinged and attached to an elongated neck that can be extended through an endoscope to reach the surgical area inside a patient's alimentary tract. The opposite end of the instrument's elongated neck comprises one or more means of opening and closing the forceps, often embodied as handles, knobs, levers, slides, or similar mechanisms for manually opening and closing the forceps via one or more cords within the neck. Certain embodiments may contain an electronic means of manipulation such as a joystick that allows the doctor to reposition the forceps in addition to opening and closing them.
Gastroscopic banding instruments, sometimes referred to as ligation devices, are also known. These instruments deploy one or more bands, usually made of natural or synthetic rubber or a polymer with similar properties, to capture tissue within the patient's alimentary tract. Such instruments are often designed to carry multiple bands around a barrel-shaped distal end, with the barrel overlaying the tissue to be banded and a proximal end allowing the doctor to deploy the bands by pulling a wire or using a similar deployment mechanism. Such devices can thus ligate multiple tissue areas during a single deployment.
As employed in the inventive surgical procedure, a tissue grasping device is to be used in combination with a gastroscopic banding device to gather and band tissue around the margin of a patient's ostomy margin, thus gradually tightening the margin and decreasing the size of the ostomy after postoperative stretching of such tissue has occurred. The tissue is first secured with the grasping device, then ligated with the banding device. The tightening of one or more tissue areas on the ostomy margin allows the ostomy to again provide the passage-limiting function originally intended by the RYGBP procedure, thereby assisting the patient in continuing to maintain his or her decreased caloric intake and weight.
In practice, each of the grasping device and the banding device have a proximal end with user controls and a distal end for engaging tissue. Typically, the distal end of a grasping device will comprise a set of one or more forceps/graspers, while the distal end of a banding device will comprise a hollow piece, often barrel-shaped and surrounded by one or more bands, such hollow piece for holding a tissue segment and deploying a band around such tissue segment. Each device is extended through the endoscopic tube/channel. The distal end of the grasping device, or at least the forceps/graspers of the grasping device, emerge from the distal end of the endoscope's tube/channel to engage a segment of healthy tissue, gently pulling that tissue segment into the distal end of the banding device. Once the tissue segment is within the hollow piece of the banding device, the user deploys the band, and each device can be withdrawn. The length of a tissue segment to be grasped and banded ranges from 0.5 cm to 3 cm, preferably between 1-2 cm.
In a preferred embodiment, the grasping device holds the tissue until the band is deployed. In another iteration, the grasping device releases the tissue segment upon insertion into the banding device.
In a preferred embodiment, the grasping device pulls the engaged tissue segment into the tube/channel, where the banding device engages and bands the segment, which is then moved back outside by the grasping device before the grasping device is withdrawn. In another iteration, the distal ends of the grasping and banding device both engage the tissue entirely outside the endoscope tube/channel.
In particular, the inventive process is directed to the use of a single channel endoscope/gastroscope comprising an instrument channel with a 2.4-3.8 mm diameter, preferably a 2.8 mm diameter. Also preferred is the use of a tissue grasping device with forceps/graspers embodied as a screw mechanism incorporated into a catheter, to enable pulling of the grasped tissue into the endoscope/gastroscope channel, thus maximizing the amount of tissue to be banded and improving the efficacy of the tissue stretching effect on the ostomy margin.
In a primary embodiment, the TORe-B procedure involves the following steps:
MAC anesthesia is considered safer than that of general anesthesia in that lower dosages of drugs are typically administered, with the dosages set for pain prevention in the patient's specific case, allowing for light, moderate or deep sedation. Unlike general anesthesia, no endotracheal tube is required for MAC. Further, MAC is associated with briefer hospital stays and lower 30-day mortality rates than general anesthesia.
BiCap cautery and direct current cautery are both types of electrocautery, wherein a metal wire electrode is delivered through an endoscope and activated, thus delivering current to cauterize tissue around the ostomy margin. The application of cautery at this point establishes an inflammatory process in the margin tissue to accelerate scar formation during the healing process.
The inventive procedure is unique in a number of respects:
The references recited herein are incorporated herein in their entirety, particularly as they relate to teaching the level of ordinary skill in this art and for any disclosure necessary for the common understanding of the subject matter of the claimed invention. It will be clear to a person of ordinary skill in the art that the above embodiments may be altered or that insubstantial changes may be made without departing from the scope of the invention. Accordingly, the scope of the invention is determined by the scope of the following claims and their equitable equivalents.
This patent application claims priority to U.S. provisional patent application 63/333,403, filed on Apr. 21, 2022.
| Number | Date | Country | |
|---|---|---|---|
| 63333403 | Apr 2022 | US |
