Patent Publication Number: US-2023149196-A1

Title: Low Risk, Reversible, Weight Loss Procedure

Description:
BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present disclosure relates generally to a medical procedure to reduce stomach volume. More particularly the present disclosure relates to an endoscopic and minimally invasive method of reducing stomach volume. 
     Description of Related Art 
     Obesity is a major health issue throughout much of the world, especially in the United States. In 2015, it was estimated that 107.7 million children and 603.7 million adults were obese worldwide. Over one third of American adults are obese, and obesity rates continue to increase. 
     While dieting, exercising, and medicinal solutions exist, weight loss surgery (WLS) is the most effective intervention to reduce body weight and obesity-associated diseases among obese patients and has become a widely accepted approach to treating these disorders. However, there are many shortcomings of the existing weight loss surgery procedures. Many involve accessing the stomach surgically, which has numerous related dangers. Also, many procedures cut and/or suture the stomach. This causes trauma to the stomach tissue as well as the related risks of anesthetics, as well as infection, and the like which result from any cutting or puncturing of bodily tissue. Further, many of these methods are complex, invasive, and require substantial recovery time and dietary shifts to allow the body to heal and to allow the stomach to resume normal operation. All of these factors lead to weight loss surgery and the existing procedures being expensive and risky. 
     SUMMARY OF THE INVENTION 
     The subject matter of this application may involve, in some cases, interrelated products, alternative solutions to a particular problem, and/or a plurality of different uses of a single system or article. 
     In one aspect, a method of reducing stomach volume is provided. The method involves gathering a quantity of stomach tissue of a stomach of a patient, and securing the gathered quantity of stomach tissue in the gathered position so as to reduce a volume of the stomach of the patient. 
     In another aspect, an endoscopic method of reducing stomach volume is provided. The method involves inserting an endoscope comprising at least one tool into a stomach of a patient. The endoscope and tool are used for gathering a quantity of stomach tissue of the stomach of the patient, and for securing the gathered quantity of stomach tissue in the gathered position so as to reduce the effective volume of the stomach of the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    provides an endoscopic embodiment of the performance of the procedure is shown. 
         FIG.  2    provides a detail view of an embodiment of the gathered stomach tissue. 
         FIG.  3    provides a detail view of an embodiment of the gathered stomach tissue 
         FIG.  4    provides a view of an embodiment of the procedure using a suction endoscope tool. 
         FIG.  5    provides a view of an embodiment of an endoscope and endoscopic tools. 
         FIG.  6    provides a view of an embodiment of an endoscope and endoscopic tools. 
     
    
    
     DETAILED DESCRIPTION 
     The detailed description set forth below in connection with the appended drawings is intended as a description of presently preferred embodiments of the invention and does not represent the only forms in which the present invention may be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments. 
     The present invention solves many problems of the prior art. The present disclosure relates to a new medical weight loss procedure which reduces stomach volume by gathering a portion of the stomach tissue together and holding it in place. This draws the remainder of the stomach closer together, reducing the effective stomach volume. The procedure may be done endoscopically in certain embodiments, greatly minimizing its invasiveness and greatly increasing the speed of the procedure and recovery. The stomach and other gastrointestinal organs, in most embodiments, remain fully intact, which can allow the procedure to be reversed easily. This procedure also allows the body to be able to process food as before the procedure, with no nutrient deficiencies as is experienced in many other procedures. In many cases, the procedure disclosed herein can be used for patients with conditions that may not make them eligible for other treatment methods, such as children and slightly overweight individuals. Further still, typically there will be limited post-procedure restrictions, such as type of food or food quantity limits as is the case with other prior art methods. Prior art procedures often require a liquid only diet, proceeding to soft food and then finally regular food which adds recovery challenges. 
     Generally, the method of this disclosure involves the gathering of a portion of stomach tissue and then securing it in place so as to decrease the overall effective volume of the stomach. Care may be taken to secure the stomach tissue together gently, so as not to damage the tissue or excessively cut off blood flow. In so doing, the feeling of satiety is achieved with a much smaller amount of food, without restriction on type or quality of food. For example, the stomach tissue may be gathered into a ball or other shape, and then held in place by a wrap, band, tie, ring, band, covering, net, balloon, and the like. By gathering up the stomach tissue and holding it in place, the effective stomach volume is reduced in a way which avoids the cutting or external access limitations of the prior art procedures. 
     The gathering discussed herein refers to the bringing together of stomach tissue. This may be done in any number of ways, and the gathering is used generally to discuss a way to reduce the effective stomach volume by adjusting the shape of the stomach from its natural shape to reduce volume. As discussed below, the gathering may be in the form of bringing the stomach tissue into a ball, drawing it inwards, folding it, wrapping it, and so on. Non-limiting examples of the gathering are also shown in the figures, as discussed in detail below. 
     In a particular embodiment, the procedure of reducing the effective stomach volume will be performed endoscopically using an endoscope. For example, an endoscope with appropriate tools may be inserted through the patient&#39;s esophagus (via either the mouth or the nose) and into the stomach. The endoscope will be guided to a predetermined area of the stomach, and tools of the endoscope will be used to gather a predetermined amount of the stomach tissue together, for example into a ball or similar shape, and then to wrap a tie or similar retainer structure around the gathered tissue to hold it in place. The endoscope may use any type of tool or tools to achieve the stomach tissue gathering. For example, a suction tool may be used to draw the stomach tissue in, and then a pincer or other manipulating tool may be used to apply the tie to hold the tissue together. In another embodiment a grasping or pincer tool may be used to grab a portion or portions of the stomach tissue, and draw it inward, and then another pincer or other manipulating tool may be used to apply the tie to hold the tissue together. In some embodiments, the stomach tissue may be gathered and held in place at more than one location, depending on desired results, patient needs, and stomach configuration. For convenience, this gathered and held stomach tissue will be referred to as a “ball” though of course it need not be in that shape. This procedure may be carried out by a person operating the endoscope (or other device used to carry out the procedure), or may be performed by a computerized robotics machine. 
     The amount of stomach tissue gathered, and thus the amount of effective stomach volume reduced, will vary from patient to patient. The amount will depend on the existing size of the stomach and the anticipated and/or desired weight loss rate. 
     In many instances, the stomach ball may be untied or otherwise released allowing the procedure to be reversed. The stomach will then revert to close to its previous size and shape. Further, in other embodiments, the stomach ball may be cut and stitched to completely remove the stomach tissue after it is gathered. In a further particular embodiment, the endoscope may hold the removed stomach tissue and bring it out of the body when the endoscope is removed. However, this cutting is not performed in most embodiments so as to allow for a safer, quicker, less invasive, reversible procedure with a quicker recovery time compared to the prior art methods which involve cutting large sections of the stomach tissue. 
     In certain embodiments, the stomach tissue ball may be secured by a band which may wrap around part of the gathered stomach tissue to hold it in place. In one embodiment, the band may be able to be tightened and/or loosened remotely. For example, a small motor engaged with the band may allow for the tightening or loosening. A signal receiver or transceiver may be in communication with the motor and capable of activating the motor upon receipt of a signal. This arrangement allows for adjustment of the band remotely from outside of the body. 
     In various embodiments, this band (or whatever other structure is used to hold the tissue together, examples of which are provided above) may comprise a marker to allow it to be identified from outside the body. For example, the marker may be identifiable by radiation, through ultrasound or x-ray, magnetically, as an RFID chip, and the like. For example, the marker may be selected of a material which is opaque when viewed on an X-ray or ultrasound. 
     While the present procedure has been discussed largely in terms of an endoscopic procedure, it should be understood that this is not necessarily required. Indeed, the disclosure relates to any procedure which can reduce effective stomach volume by gathering together stomach tissue and holding it in place, endoscopically or otherwise. 
     Turning now to  FIG.  1   , an endoscopic embodiment of the performance of the procedure is shown. In this view, the patient  1  has the endoscope  10  passing through the mouth and esophagus and into the stomach  12 . The endoscope tool  13  has gathered stomach tissue from an interior of the stomach and formed it into a ball type shape  15 . A band  14  is wrapped around the stomach tissue to hold the gathered tissue in place, thereby securing the stomach in a reduced-volume position compared to its original volume without the gathered stomach tissue  15 . As shown in this figure, the procedure is performed on the greater curvature of the stomach in this embodiment, though any area of the stomach may be used. 
       FIG.  2    provides a detail view of an embodiment of the gathered stomach tissue ball. In this view, the stomach tissue is gathered and formed into a ball  15 . A band  14  separates the gathered ball  15  from the remainder of the stomach  12 . This band  14  comprises a marker  16 , which may be any marker which allows identification of the location of the band  14 . 
       FIG.  3    provides a detail view of an embodiment of the gathered stomach tissue “ball.” In this view, a net or mesh wrap  31  surrounds the gathered stomach tissue ball  15 , holding it together and in place. Of course, the wrap  13  may be made of any material, permeable or not, without straying from the scope of this invention. 
       FIG.  4    provides a view of an embodiment of the procedure using a suction endoscope tool. In this embodiment, an area of the stomach  12  is contacted by a suction cup  41 . A low pressure is drawn through tube  40 , causing the stomach tissue to be drawn into, and held by, the cup  41 . From there, the cup  41  may be drawn away from the rest of the stomach  12 , gathering the stomach tissue. This gathered tissue may then be secured together (not shown) so as to reduce the effective volume of the stomach  12 . 
       FIGS.  5  and  6    provide exemplary embodiments of tools of endoscopes which may be used to perform the procedure of the subject disclosure.  FIG.  5    provides an embodiment of the endoscope  10  having tools  52  and  51 . These tools  52 ,  51  are movable and operable by the endoscope operator. Tool  52  is a pincer which can hold a portion of stomach tissue and draw it to a gathered position, in some cases with the aid of tool  51  which is a hook. Once gathered, these tools may then be used to secure the tissue in place, using any one or more of the various structures disclosed above, or any other method or structure to secure the tissue together and in place.  FIG.  6    provides an embodiment of the endoscope  10  having tools  62  and  61 . Tool  61  is a pincer, while tool  62  is movable as a finger to push, hold, and guide as needed. The tools, alone or in combination can be used to gather a portion of stomach tissue together. In some cases, an endoscope having three tools is used, with two tools holding the stomach tissue, and a third applying the band (or other structure) to secure the gathered stomach tissue. The endoscope  10  tools  61 ,  62  may then be used to secure the gathered tissue in place using any of the structures disclosed above, or any other method or structure. 
     In one embodiment of the securing of the stomach tissue using an endoscope and tool(s), a pincer tool may hold open a ring or band and pass it over the gathered tissue, the ring or band may then be tightened, tied, or otherwise tightened to secure the stomach tissue in place. If the ring is elastic, it may be stretched wide and then allowed to relax to a tightened position to secure the stomach tissue in place. A similar operation may be performed with two finger type endoscope tools to hold opposite sides of the ring/band etc. In another embodiment, two pincer tools may be used to hold opposite ends of a tie, each tool can bring the opposite sides together over the gathered tissue and connect them, holding the tissue in the gathered position. 
     While several variations of the present invention have been illustrated by way of example in preferred or particular embodiments, it is apparent that further embodiments could be developed within the spirit and scope of the present invention, or the inventive concept thereof. However, it is to be expressly understood that such modifications and adaptations are within the spirit and scope of the present invention, and are inclusive, but not limited to the following appended claims as set forth. Moreover, while certain aspects of the invention are disclosed with certain embodiments, it is to be understood that these different aspects of the embodiments may be combined and interchanged with other embodiments. Indeed by this written disclosure, any element, step, or other aspect of one disclosed embodiment may be equally applied to any other embodiment without straying from the scope of this invention.