Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
ADJUSTABLE GASTRIC BAND
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[1] The present disclosure relates to an implant. More particularly, the present disclosure relates to an adjustable gastric band.
BACKGROUND OF INVENTION
[2] Obesity is a complex health issue characterized by excessive body fat accumulation, which significantly increases the risk of various chronic diseases such as heart disease, type 2 diabetes, stroke, certain types of cancer, and sleep apnea.
[3] When lifestyle interventions like diet and exercise fail to achieve significant weight loss, surgery may be considered for individuals with severe obesity (a BMI of 40 or higher) or those with a BMI of 35 or higher who also have obesity-related health problems. Bariatric surgery, also known as weight loss surgery, involves altering the digestive system to either reduce food intake or limit nutrient absorption. Common types of bariatric surgery include gastric bypass and sleeve gastrectomy. These surgeries aim to modify the stomach and intestines to treat obesity and related diseases by reducing the stomach size. This allows the patient to eat and drink less at one time, helping to control overeating.
[4] However, these surgeries, as a standalone intervention, may be less effective for weight loss. This is due to certain complications that occur post-surgery, for example, dumping syndrome, where food moves rapidly through the digestive tract, leading to symptoms like nausea, diarrhea, abdominal cramping. These complications make dietary adjustments challenging. Another issue includes stomach or pouch dilation, where the pouch created during the surgery stretches over time. Further, behavioral or psychological challenges have also been observed, where some patients struggle to adhere to post-surgery lifestyle changes, resulting in poor eating habits, etc. These factors may lead to insufficient weight loss or weight regain. Long-term risks may include weight regain, bowel obstructions, hernias, and psychological challenges.
[5] To address these challenges, a gastric band may be used. The gastric band is placed around a part of the stomach, creating a small pouch. This restriction slows food passage through the digestive tract and limits the amount of food that can be consumed at one time, helping the patient feel full sooner and lose weight effectively.
[6] However, conventional gastric bands lack adjustability, which may require the production of a variety of band sizes tailored to different patients’ anatomies. This may increase the manufacturing expense, and hospitals may need to maintain a large inventories for different band sizes, which can strain budgets and storage capacity.
[7] During the surgery, the surgeon is required to select an optimal band size for a patient. This often involves a trial-and-error process, where different bands must be tested to ensure the correct fit. This not only increases procedural complexity and requires more time but also elevates the risk to the patient. The process of selecting the optimal band size is exhaustive and prone to human error, which may lead to improper sizing. Improper sizing may lead to issues/complications like erosion, slippage or esophageal dilation. An ill-fitting band may create a fixed level of restriction around the tissues. This can lead to either over-restriction, causing esophageal dilation, acid reflux, or vomiting, or under-restriction. This may result in inadequate weight loss, causing discomfort or complication. Ultimately, such complications may necessitate revision surgery, increasing both costs and risks for the patient.
[8] Thus, there arises a need for a gastric band that overcomes the problems associated with the conventional gastric bands.
SUMMARY OF INVENTION
[9] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[10] The present disclosure relates to a gastric band. The gastric band includes a strap and a locking assembly. The strap includes a first end and a second end. In an embodiment, a second portion of the strap towards the second end overlaps with a first portion of the strap towards the first end to form a ring. In an embodiment, the locking assembly includes a support member, a lever and a stopper. The support member is coupled to the strap. The lever is pivotally coupled to the support member. The stopper is coupled to the lever. In an embodiment, the stopper includes a flap resting on an outer surface of the strap. In response to actuation of the lever, the flap of the stopper is configured to move upwards and facilitate movement of the strap to adjust a circumferential size of the ring.
BRIEF DESCRIPTION OF DRAWINGS
[11] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[12] Fig. 1a depicts a perspective view of a gastric band 100, according to an embodiment of the present disclosure.
[13] Fig. 1b depicts an exploded view of the gastric band 100, according to an embodiment of the present disclosure.
[14] Fig. 2 depicts the gastric band 100 implanted at a target site within a patient’s stomach, according to an embodiment of the present disclosure.
[15] Figs. 3a-3d depict the gastric band 100 adjusted at different sizes, according to an embodiment of the present disclosure.
[16] Fig. 4 depicts a perspective view of a strap 110, according to an embodiment of the present disclosure.
[17] Fig. 5a depicts a perspective view of a locking assembly 120, according to an embodiment of the present disclosure.
[18] Fig. 5b depicts a perspective view of a support member 121, according to an embodiment of the present disclosure.
[19] Fig. 5c depicts a perspective view of a pin 129, according to the embodiment of the present disclosure.
[20] Fig. 5d depicts a perspective view of a lever 123, according to the embodiment of the present disclosure.
[21] Fig. 5e depicts a perspective view of a stopper 125, according to an embodiment of the present disclosure.
[22] Fig. 5f depicts a coupling between the lever 123 and the stopper 125, according to an embodiment of the present disclosure.
[23] Fig. 6 depicts a flowchart of a method 600 of using the gastric band 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[24] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[25] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[26] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[27] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[28] The present disclosure relates to an adjustable gastric band (hereinafter interchangeably referred to as a gastric band) according to the embodiment of the present disclosure. The gastric band is placed around the upper part of the stomach, creating a small pouch that limits the amount of food the stomach can hold. Thus, the patient feels full with a smaller food intake, leading to reduced calorie intake. Therefore, placing the gastric band around the stomach pouch controls increased gastric reservoir capacity and prevents dilation. The proposed gastric band is adjustable for multiple size options and may be connected at any one of the multiple size options based on requirements. The adjustability of the proposed gastric band gives a surgeon the flexibility to customize the gastric band according to an individual patient’s needs, thereby obtaining optimal results for the patient. Since a single gastric band can be used to achieve multiple sizes, the need for separate bands for different sizes is eliminated. This reduces the number of components and associated costs. Further, when a surgeon needs to trial different sizes to assess an optimal fit for a patient, the surgeon can simply adjust the size of the proposed adjustable gastric band to assess the fit. As a result, the overall procedural time is reduced unlike conventional gastric bands, where the surgeon must implant, test and remove conventional gastric bands of different sizes before deciding on a desired size. Thus, the proposed adjustable gastric band make the overall implantation procedure more efficient, leading to the increased success rate of weight loss surgery and decreasing the occurrence of gastric outlet stenosis, hypoglycemia, and dumping. The gastric band includes a locking mechanism for locking the gastric band at a desired size. The proposed locking mechanism is easier to operate and does not require any specialized instrument for unlocking unlike conventional gastric band. Therefore, the proposed gastric band has a simpler design and is more user friendly.
[29] Now, referring to figures, Fig. 1a depicts a perspective view of a gastric band 100 and Fig. 1b depicts an exploded view of the gastric band 100. The gastric band 100 is used in laparoscopic adjustable gastric banding (LAGB), a type of bariatric surgery. The gastric band 100 is placed around the upper part of the stomach, as shown in Fig. 2. Upon placing the strap 110 around the esophageal junction, a small pouch is created, reducing food capacity and promoting weight loss. The gastric band 100 is adjustable and can be set at different sizes. The adjustability of the gastric band 100 allows it to be tailored to the patient’s anatomy, ensuring a proper fit around the stomach during the procedure and providing optimal results. Figs. 3a-3b depict a perspective and a side view of the gastric band 100 set at one exemplary size, and Figs. 3c-3d depict a perspective and a side view of the gastric band 100 set at another exemplary size. In an embodiment, the gastric band 100 includes a strap 110 and a locking assembly 120, as shown in Fig. 1a. The locking assembly 120 is coupled to the strap 110. The locking assembly 120 facilitates adjustment of the strap 110 at a desired size during the procedure and once adjusted, the locking assembly 120 ensures that the strap 110 remains securely in place at the desired size, preventing post-operative loosening of the gastric band 100. Consequently, the chances of a revision surgery are reduced and the patient outcome is improved.
[30] Fig. 4 depicts a perspective view of the strap 110, according to an embodiment of the present disclosure. In an embodiment, the strap 110 is generally rectangular in shape. The strap 110 forms a ring like structure when the gastric band 100 is assembled and placed at the target site. An inner surface of the strap 110 is configured to contact an outer surface of the esophageal junction. In an embodiment, the strap 110 has a first end 110a and a second end 110b. The first end 110a of the strap 110 is coupled to the locking assembly 120. In an embodiment, the strap 110 includes a hole 110c provided at the first end 110a. The hole 110c extends throughout the width of the strap 110. The hole 110c is used in coupling the strap 110 with the locking assembly 120. A second portion 110e of the strap 110 towards the second end 110b overlaps with a first portion 110d of the strap 110 towards the first end 110a to form the ring like structure, as shown in Fig 4. The strap 110 may be made of a biocompatible material, including, without limitation, silicone, polyether block amide (PEBA), Polyurethane, polyetheretherketone (PEEK), etc., or a combination thereof. In an exemplary embodiment, the strap 110 is made of silicone. The dimensions of the strap 110 may be chosen based upon requirements, for example, based upon the anatomy of a patient population in consideration. The strap 110 may have a predefined length, a predefined width and a predefined thickness ranging between 180 mm and 300 mm, 15 mm and 25 mm, and 1.5 mm and 2.5 mm, respectively. In an example implementation, the length, width and thickness of the strap 110 are 200 mm, 18 mm and 2 mm, respectively.
[31] The strap 110 includes a plurality of markers 111 (hereinafter, markers 111) provided on an outer surface of the strap 110 for at least partial length of the strap 110. In an embodiment, the markers 111 are provided on a partial length of the strap 110. The markers 111 are spaced apart from each other. Each marker 111 indicates a corresponding size of the gastric band 100 that determines the degree of stomach restriction. The markers 111 assist in achieving a precise fit based on the patient’s anatomy and help guide the adjustment of the gastric band 100 during the procedure.
[32] The markers 111 may take various forms and may be arranged in a pre-defined pattern. In an embodiment, the markers 111 are in the form of vertical lines spaced apart from each other, resembling markings on a measuring scale. In various embodiments, the markers 111 may take other forms, such as, dots, lines, color-coded marked, numeric values, etc. The markers 111 serves as a reference point for indicating the size of the strap 110 to be adjusted depending upon the patient’s anatomy. In an embodiment, the markers 111 indicate respective circumferential sizes of the strap 110. For example, the markers 111 may indicate the circumferential size as a diameter of the gastric band 100 in its ring form or a circumference of the gastric band 100 in its ring form. The circumferential size of the strap 110 may be adjusted by a surgeon as required depending upon a patient’s anatomy.
[33] Fig. 5a depicts the locking assembly 120 of the gastric band 100, according to an embodiment of the present disclosure. The locking assembly 120 has a first end 120a, a second end 120b, a third end 120c, a fourth end 120d. In an embodiment, the locking assembly 120 includes a support member 121, a lever 123, and a stopper 125. The locking assembly 120 is configured to lock the strap 110 at a desired size as per the need of the medical practitioner. The locking assembly 120 is used to lock and unlock the strap 110 as desired during a surgical procedure.
[34] Fig. 5b depicts the support member 121, according to an embodiment. The support member 121 provides support to the lever 123 and the stopper 125. The support member 121 also acts as a support for the strap 110. The support member 121 may be made of a biocompatible material including, without limitation, nitinol, stainless steel (SS), titanium, Cobalt chromium, etc. In an exemplary embodiment, the support member 121 is made of nitinol or stainless steel (SS). In an embodiment, the support member 121 generally has a tray like structure. However, other shapes of support member 121 may be possible and are within the scope of the teachings of the present disclosure. In an embodiment, the support member 121 includes a base 121a, a first side wall 121b and a second side wall 121c.
[35] The strap 110 is configured to rest on the base 121a of the support member 121, specifically, a part of the strap 110 rests on the base 121a. . The base 121a generally has an arc shape, which matches with the ring-like shape of the strap 110, contouring to the circular shape of the gastroesophageal junction. The first side wall 121b and the second side wall 121c are coupled to the base 121a towards the third end 120c and the fourth end 120d, respectively. For example, the first side wall 121b and the second side wall 121c are integrally coupled to the base 121a and extend upward from the base 121a.
[36] The support member 121 is coupled to the strap 110, for example, using a pin 129. In an embodiment, the strap 110 is coupled to the first side wall 121b and the second side wall 121c of the support member 121 using the pin 129. In an embodiment, the first side wall 121b and the second side wall 121c include a first aperture A and a second aperture B, respectively. The first aperture A and the second aperture B are provided towards the first end 120a of the locking assembly 120, for example, at the bottom corner of the first side wall 121b and the second side wall side 121c. In an embodiment, the hole 110c (provided towards the first end 110a of the strap 110), the first aperture A and the second aperture B of the support member 121 are configured to receive the pin 129, thereby coupling the strap 110 with the support member 121.
[37] Fig. 5c illustrates an exemplary pin 129. In an embodiment, the pin 129 includes a body 129a and two discs 129b. The body 129a generally has a cylindrical structure. Each disc 129b is coupled at either end of the body 129a. In an embodiment, the discs (129b) have a circular shape, though it may have any other shape, e.g., hexagonal. The discs 129b may be coupled to the ends of body 129a of the pin 129 using techniques, such as, without limitation, UV bonding, laser welding, soldering, brazing, spot welding, etc.
[38] The body 129a of the pin 129 is disposed within the hole 110c of the strap 110. The ends of the body 129a are coupled to the support member 121. Each of the first aperture A and the second aperture B is configured to receive a respective end of the body 129a, thereby coupling the strap 110 with the support member 121. The discs 129b are disposed on an outer surface of the first side wall 121b and the second side wall 121c of the support member 121, respectively. The discs 129b have a diameter that is larger than the diameters of the body 129a, the first aperture A, and the second aperture B, preventing the slippage of the pin 129 through the apertures (A and B), thereby securely coupling the strap 110 with the support member 121.
[39] The pin 129 may be made of a material, without limitation, Nitinol, stainless steel, titanium, cobalt chromium, etc. In an exemplary embodiment, the pin 129 is made of nitinol or stainless steel (SS).
[40] The first side wall 121b and the second side wall 121c include a first hole 121d and a second hole 121e, respectively, towards the second end 120b, as shown in Fig. 5b. The first hole 121d and the second hole 121e may have any suitable shape. In an embodiment, the first hole 121d and the second hole 121e are circular holes. The first hole 121d and the second hole 121e are provided towards a top corner of the first side wall 121b and the second side wall 121c, respectively, at the second end 120b. The first hole 121d and the second hole 121e are aligned with each other. The first hole 121d and the second hole 121e extends for an entire width of the first side wall 121b and the second side wall 121c, respectively. The first hole 121d and the second hole 121e help in coupling the support member 121 with the lever 123.
[41] In an embodiment, each of the first side wall 121b and the second side wall 121c include a respective arched portion 121b1, 121c1 provided at a top end of the locking assembly 120 towards the second end 120b. The first hole 121d and the second hole 121e are provided in the arched portions 121b1 and 121c1 of the first side wall 121b and the second side wall 121c, respectively.
[42] In an embodiment, the support member 121 includes a slab 121g provided towards the first end 120a. The slab 121g is coupled to the first side wall 121b and the second side wall 121c at the first end 120a of the locking assembly 120. In an embodiment, the slab 121g, the first side wall 121b and the second side wall 121c are integrally coupled, forming an integrated structure, though they may be separate components coupled using together any suitable techniques. The slab 121g helps in holding the strap 110 in its position. The slab 121g is spaced apart from the base 121a, defining a gap 121f. The second end 110b of the strap 110 passes through the gap 121f. In other words, a part of the strap 110 is disposed within the gap 121f.
[43] In an embodiment, the support member 121 includes one or more pointers 121h (hereinafter, the pointers 121h). For example, at least one of the first side wall 121b or the second side wall 121c includes the one or more pointers 121h. In an exemplary embodiment, one pointer 121h is provided on a top surface of each of the first side wall 121b and the second side wall 121c and aligned with each other. In an embodiment, the pointers 121h may be radiopaque. The pointers 121h may have a predefined shape, such as, without limitation, triangle, V-shape, arrow-shape, circular dot, thick straight line, etc. In an embodiment, the pointers 121h have an arrow shape. During implantation of the gastric band 100, a desired marker 111 of the plurality of marker 111 is aligned with the pointer 121h. Together, the pointers 121h of the support member 121 and the markers 111 of the strap 110 visually guide the medical practitioners to determine how much the strap 110 is to be adjusted to achieve a desired size.
[44] In an embodiment, the base 121a, the first side wall 121b and the second side wall 121c are integrally coupled, forming an integrated structure, as described herein. It should be understood though that the base 121a, the first side wall 121b and the second side wall 121c may be separate components and the base 121a may be coupled to the first side wall 121b and the second side wall 121c using any suitable techniques.
[45] Fig. 5d depicts the lever 123, according to an embodiment. The lever 123 is pivotably (or pivotally) coupled to the support member 121 towards the first end 120a. The lever 123 includes a bar 123a, a rod 123b, and two side plates 123c. The bar 123a and the rod 123b are coupled to each other via the side plates 123c. The side plates 123c are configured to transfer the motion of the bar 123a to the rod 123b and vice versa. The plates 123c may have a pre-defined shape, such as, without limitation, L-shape, T-shape, V-shape, etc. In an exemplary embodiment, the plates 123c have an inverted L-shape. Each plate 123c includes a first portion 123c1 and a second portion 123c2.
[46] The bar 123a is rectangular in shape, though it may have any other shape. Each end of the bar 123a is coupled to the first portion 123c1 of a respective plate 123c. The bar 123a of the lever 123 is configured to be pulled downwards while adjusting the strap 110 according to the patient’s anatomy.
[47] The rod 123b is cylindrical in shape, though it may have any other shape. The rod 123b has a first end 123b1 and a second end 123b2. Each of the first end 123b1 and the second end 123b2 of the rod 123b is coupled to the second portion 123c2 of the respective side plate 123c. A portion of the rod 123b towards the first end 123b1 resides within the first hole 121d of the support member 121. Similarly, a portion of the rod 123b towards second end 123b2 resides within the second hole 121e of the support member 121. The dimensions of first hole 121d and the second hole 121e are design such that the rod 123b is rotatable. The rod 123b helps in pivotal coupling of the lever 123 with the support member 121.
[48] In an embodiment, the bar 123a, the rod 123b, and the side plates 123c are integrally coupled to form an integrated structure as described herein. However, the bar 123a, the rod 123b, and the side plates 123c may be separate components coupled together using any suitable coupling technique. The lever 123 may be made of a biocompatible material, without limitation, Nitinol, stainless steel, titanium, cobalt chromium, etc. In an exemplary embodiment, the lever 123 is made of nitinol or stainless steel (SS).
[49] Fig. 5e illustrates an exemplary stopper 125. The stopper 125 is coupled to the lever 123, specifically, to the rod 123b of the lever 123. In a locked state, the stopper 125 prevents any unwanted displacement of the strap 110, thereby locking the strap 110 at a fixed position. In an embodiment, the stopper 125 includes a flap 125a and a tubular portion 125b. The tubular portion 125b helps in coupling the stopper 125 with the rod 123b of the lever 123. In an embodiment, the tubular portion 125b is hollow from inside, thus defining a lumen 125c. The lumen 125c of the tubular portion 125b is configured to receive the rod 123b. The diameter of the lumen 125c is designed such that the rod 123b is able to rotate freely. The flap 125a extends from the tubular portion 125b towards second end 120b of the locking assembly 120. At least a portion of the flap 125a rests on an outer surface of the strap 110. In an embodiment, a tip of the flap 125a of the stopper 125 rests on the strap 110. The flap 125a acts a stopper and prevents the dislocation of the strap 110. The flap 125a may have pre-defined shape, such as, without limitation, trapezium, square, rectangular, semi-circular, triangular, etc. At least In an exemplary embodiment, the flap 125a of the stopper 125 is trapezium in shape. The stopper 125 may be made of a biocompatible material, without limitation, Nitinol, stainless steel, titanium, cobalt chromium, etc. In an exemplary embodiment, the stopper 125 is made of stainless steel.
[50] The locking assembly 120 includes one or more resilient members 127 (hereinafter, referred to as resilient members 127), as shown in Fig. 5f. In an embodiment, the locking assembly 120 includes two resilient members 127. The resilient members 127 are wound around the rod 123b. For example, one resilient member 127 is wound around the rod 123b towards the first end 123b1 and the other resilient member 127 is wound around the rod 123b towards the second end 123b2. Each resilient member 127 is coupled to the tubular portion 125b of the stopper 125 and to a respective one of the first side wall 121b and the second side wall 121c. Each resilient member 127 has a first end (not shown) and a second end 127b. The first end of each resilient member 127 is coupled to the tubular portion 125b of the stopper 125. In one embodiment, the tubular portion 125b includes holes (not shown) at either ends to accommodate the first end of a respective resilient member 127. The first end of each resilient member 127 fits into the respective hole and is securely attached to tubular portion 125b of the stopper 125. The second end 127b of each resilient member 127 is fixedly coupled to a respective one of the first side wall 121b or the second side wall 121c of the support member 121. The second end 127b of each resilient member 127 is disposed in a corresponding hole (not shown) of the first side wall 121b and the second side wall 121c. In an embodiment, the resilient members 127 are torsion springs. The resilient members 127 may be made of a biocompatible material, without limitation, nitinol, stainless steel, titanium, cobalt chromium, etc. In an exemplary embodiment, the resilient members 127 are made of stainless steel .
[51] The locking and unlocking action of the locking assembly 120 is explained below. When the locking assembly 120 is in a locked state, the locking assembly 120 prevent any unwanted displacement of the strap 110, maintaining the strap 110 fixed at a chosen size. To adjust the size of the strap 110 (and thereby, of the gastric band 100), the locking assembly 120 is unlocked. In an embodiment, the locking assembly 120 is unlocked by actuating the lever 123. In response to the actuation of the lever 123, the flap 125a of the stopper 125 is configured to move upwards and facilitate movement of the strap 110 to adjust a circumferential size of the ring. According to an embodiment, the lever 123 is actuated by moving the bar 123a downward. In response to the movement of the bar 123a of the lever 123 downwards, the rod 123b of the lever 123 is configured to rotate about its longitudinal axis in a first direction (e.g., clockwise in the depicted embodiment). In response to the rotation of the rod 123b, the resilient members 127 of the at least one resilient member (127) are configured to twist, creating a tension on the stopper 125. This causes the tubular portion 125b to rotate in the first direction and the flap 125a to move/lift upwards. As a result, the flap 125a moves upward, disengaging from the strap 110, setting the locking assembly 120 to an unlocked state. This allows the strap 110 to be manually adjusted as needed. For example, to reduce the size of the strap 110 (hence, of the gastric band 100), the strap 110 may be moved such that the second end 110b of the strap 110 move away from the first end 110a of the strap 110. Similarly, to increase the size of the strap 110 (hence, of the gastric band 100), the strap 110 may be moved such that the second end 110b of the strap 110 moves towards the first end 110a of the strap 110. The markers 111 and the pointers 121h guide the surgeon regarding how much the strap 110 is to be moved to achieve a desired size according to the patient’s anatomy.
[52] Once a desired size of the gastric band 100 is achieved, the strap 110 is locked by setting the locking assembly 120 to a locked state. The locking assembly 120 is locked by de-actuating (or releasing) the lever 123. In an embodiment, the lever 123 is de-actuated by releasing the bar 123a. In response to releasing the bar 123a of the lever 123, the resilient members 127 are configured to apply a biasing force on the rod 123b of the lever 123 and the tubular portion 125b of the stopper 125. This force causes the rod 123b the bar 123a of the lever 123 to rotate about its longitudinal axis in a second direction opposite to the first direction (e.g., anticlockwise in the depicted embodiment) and return to respective original position. Simultaneously, the tubular portion 125b of the stopper 125 is configured to rotate in the second direction, causing the flap 125a to fall down and rest on the strap 110. Further, in response to the rotation of the rod 123b in the second direction, the side plates 123c are configured to rotate too, causing the bar 123a to return to its original position. The resilient members 127 come to the rest state and the locking assembly 120 is in the locked state.
[53] The flap 125a acts as a counterweight to the lever 123, ensuring that the bar 123a of the lever 123 remains stationary when not actuated. This prevents any unintended movement of the bar 123a of the lever 123, thereby maintaining the locked state of the locking assembly 120 and preventing the slippage of the strap 110. This maintains the desired size of the gastric band 100, as any slippage may alter the size of the gastric band 100 and compromise the effectiveness.
[54] Fig. 6 illustrates a flowchart of a method 600 for using the gastric band 100, according to an embodiment of the present disclosure. The gastric band 100 may be gastric banded in the patient’s body via a laparoscopic surgery.
[55] At step 601, one or more surgical cuts are made in the patient’s abdomen to create an access to the patient’s stomach. Through these incisions, a thin tube with a tiny camera (laparoscope) and other necessary surgical instruments are inserted, allowing the surgeon to position the gastric band 100 around the upper part of the stomach.
[56] At step 603, the gastric band 100 is inserted into the patient’s stomach and is wrapped around the patient’s stomach at a designed location, e.g., an upper part of the stomach. In an embodiment, to wrap the gastric band 100 around the patient’s stomach, the locking assembly 120 is unlocked. For example, the bar 123a of the lever 123 is pressed downwards by the medical practitioner. The second end 110b of the strap 110 is inserted between the flap 125a and the base 121a of the support member 121 and through the gap 121f of the support member 121. The second end 110b of the strap 110 is pulled until the strap 110 forms a ring-like shape.
[57] At step 605, the second end 110b of the strap 110 is pulled by the medical practitioner until a desired size of the strap 110, and thereby of the gastric band 100 is achieved. For example, the second end 110b may be pulled until one of the markers 111 corresponding to a desired size of the gastric band 100 aligns with the pointers 121h. The alignment between the marker 111 and the pointers 121h indicates the appropriate level of tightening.
[58] At step 607, once the desired size of the strap 110 is achieved, the bar 123a of the lever 123 is released and the lever 123 return to its original position as explained earlier. When the flap 125a rests upon the strap 110, it applies gentle pressure or friction against the surface of the strap 110, holding it in place. This pressure prevents the strap 110 from moving freely or loosening due to peristaltic movement. The interaction between the flap 125a and the strap 110 effectively locks the strap 110 at the adjusted position, securing it and preventing any slippage or unwanted shifting.
[59] If the medical practitioner wants to adjust the size of the gastric band 100, e.g., for trialing different sizes during the surgery, the locking assembly 120 is unlocked (as explained earlier) to enable adjustment of the strap 110. The strap 110 is then moved in a desired direction until a different size of the gastric band 100 achieved. The lever 123 is then released to lock the strap 110 with the locking assembly 120 as explained earlier. This may be done multiple times until an optimal size of the gastric band 100 based upon the patient’s anatomy is found.
[60] The proposed gastric band presents several advantages. For example, the use of the proposed gastric band is less invasive compared to traditional bariatric surgical procedures. It results in faster recovery times and lower medical costs for the patient. Further, the adjustability of the proposed gastric band at different sizes according to an individual patient’s needs eliminates the need for multiple gastric bands of various sizes as seen with conventional gastric bands. Moreover, the proposed gastric band has a simple and easy-to-use unlocking mechanism unlike in conventional gastric bands where specialized instruments may be required for unlocking or a surgeon may need to perform multiple steps for unlocking. Consequently, the gastric band of the present disclosure is easily removable and has enhanced usability compared to conventional gastric band.
[61] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. A gastric band (100) comprising:
a. a strap (110) having a first end (110a) and a second end (110b), a second portion (110e) of the strap (110) towards the second end (110b) overlaps with a first portion (110d) of the strap (110) towards the first end (110a) to form a ring; and
b. a locking assembly (120) comprising:
i. a support member (121) coupled to the strap (110);
ii. a lever (123) pivotally coupled to the support member (121); and
iii. a stopper (125) coupled to the lever (123), the stopper (125) comprising a flap (125a) resting on an outer surface of the strap (110);
c. wherein in response to actuation of the lever (123), the flap (125a) of the stopper (125) is configured to move upwards and facilitate movement of the strap (110) to adjust a circumferential size of the ring.
2. The gastric band (100) as claimed in claim 1, wherein the support member (121) comprises:
a. a base (121a);
b. a first side wall (121b) coupled to the base (121a) towards a third end (120c) of the locking assembly (120), and
c. a second side wall (121c) coupled to the base (121a) towards a fourth end (120d) of the locking assembly (120),
wherein, the strap (110) is configured to rest on the base (121a) of the support member (121);
wherein, the first side wall (121b) and the second side wall (121c) are coupled to the strap (110).
3. The gastric band (100) as claimed in claim 2, wherein the first side wall (121b) and the second side wall (121c) are coupled to the strap (110) using a pin (129) disposed within a first aperture (A) provided in the first side wall (121b), a second aperture (B) provided in the second side wall (121c) and a hole (110c) provided in the strap (110).
4. The gastric band (100) as claimed in claim 2, wherein the support member (121) comprises a slab (121g) coupled to the first side wall (121b) and the second side wall (121c) at the first end (120a) of the locking assembly (120) and is spaced apart from the base (121a) to define a gap (121f) wherein a part of the strap (110) is disposed within the gap (121f).
5. The gastric band (100) as claimed in claim 2, wherein at least one of the first side wall (121b) or the second side wall (121c) comprises one or more of pointers (121h).
6. The gastric band (100) as claimed in claim 1, wherein
a. the stopper (125) comprises:
i. a flap (125a); and
ii. a tubular portion (125b) having a lumen (125c); and
b. the lever (123) comprises:
i. a bar (123a);
ii. a rod (123b) coupled to the bar (123a) and pivotally coupled to the support member (121) and disposed within the lumen (125c) of the tubular portion (125b); and
iii. at least one resilient member (127) wound over the rod (123b) and coupled to the tubular portion (125b) and the support member (121);
c. wherein in response to a downward movement of the bar (123a), the rod (123b) is configured to rotate in a first direction, causing the at least one resilient member (127) to twist and apply a tension to rotate the tubular portion (125b) of the stopper (125) in the first direction and lift the flap (125a) of the stopper (125) upwards.
7. The gastric band (100) as claimed in claim 6, wherein the rod (123b) is disposed in a first hole (121d) and a second hole (121e) provided in a first side wall (121b) and a second side wall (121c), respectively, of the support member (121), wherein each of the at least one resilient member (127) comprises a first end coupled to the tubular portion (125b) of the stopper (125) and a second end (127b) coupled to the first side wall (121b) or the second side wall (121c) of the support member (121).
8. The gastric band (100) as claimed in claim 6, wherein the lever (123) includes two side plates (123c) are configured to couple the bar (123a) with the rod (123b) and transfer the motion of the bar (123a) to the rod (123b).
9. The gastric band (100) as claimed in claim 1, wherein the gastric band (100) comprises a plurality of markers (111) provided on at least a partial length of the strap (110).
10. The gastric band (100) as claimed in claim 1, wherein the strap (110) is made of a biocompatible material comprising silicone, polyether block amide (PEBA), Polyurethane, polyetheretherketone (PEEK), or a combination thereof.