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 BAND FOR OBESITY REDUCTION

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
[001] The present disclosure relates to medical devices. More particularly, the present disclosure relates to an adjustable band for obesity reduction.
BACKGROUND OF INVENTION
[002] Obesity has been a problem since the past several decades. However, the prevalence of obesity has remarkably increased in recent times. To address this health crisis many treatments have been devised, bariatric surgeries being one of them. Bariatric surgery is a type of weight-loss surgery that involves making changes to the digestive system to help an individual lose weight. The surgery is mainly intended for patients suffering from obesity, who have been unsuccessful in losing weight through other non-surgical treatments. The goal of these operations is to modify the stomach and intestines to treat obesity and related diseases. Mainly, these types of surgeries aim to reduce the stomach size, allowing the patient to eat and drink less at one time and still satiate the patient. This addresses the overeating, to at least some extent.
[003] There are various types of bariatric surgeries like, Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy, Biliopancreatic Diversion with Duodenal Switch, and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S). Most of these procedures are invasive, and make long term, often irreversible changes to a patient’s digestive system. On the other hand, gastric bands are less invasive and do not aim to permanently alter the digestive system of the patient. This also reduces the risk of nutrient deficiencies and other complications associated with the other, more invasive procedures.
[004] However, the conventional gastric band size depends upon patient’s anatomy. Since the anatomy varies from patient to patient, multiple sized bands need to be designed. This increases manufacturing costs. During the surgery, the surgeon may need to test bands of different sizes and decide which one fits best for that patient. This increases the requirements for maintaining inventory of such bands. Further, gastric bands known in the art have locking mechanisms that are difficult to unlock by the surgeons or require specialized unlocking instruments.
[005] Therefore, there is a need of a gastric band that overcomes these and other shortcomings associated with the gastric bands known in the art.
SUMMARY OF INVENTION
[006] 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.
[007] The present disclosure relates to a gastric sculpture band. In an embodiment, the gastric sculpture band includes a base segment, a female connector and a male connector. The base segment has a first end and a second end. The female connector, coupled to the base segment at the first end of the base segment, includes a plurality of female coupling structures. Each female coupling structure is disposed at a respective position along a length of the female connector. Each position represents a corresponding size option of a plurality of size options. The male connector, coupled to the base segment at the second end of the base segment, includes a male coupling structure configured to removably couple with the plurality of female coupling structures. In a closed position, the male coupling structure of the male connector is coupled to one of the plurality of female coupling structures of the female connector.
BRIEF DESCRIPTION OF THE DRAWINGS
[008] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1a depicts a perspective view of an adjustable band 100 for obesity reduction, in accordance with an embodiment of the present disclosure.
[0010] Fig. 1b depicts an exploded view of the adjustable band 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 2 depicts a female connector 110 of the adjustable band 100, in accordance with an embodiment of the present disclosure.
[0012] Fig. 3a depicts a side view of the adjustable band 100 in an open state, in accordance with an embodiment of the present disclosure.
[0013] Fig. 3b depicts a side view of the adjustable band 100 in a closed state, in accordance with an embodiment of the present disclosure.
[0014] Fig. 4 depicts a slider 130, in accordance with an embodiment of the present disclosure.
[0015] Figs. 5a – 5b depict views of the adjustable band 100 connected at different sizes, in accordance with an embodiment of the present disclosure.
[0016] Fig. 6 depicts a flowchart of a method 200 for using the adjustable band 100, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF DRAWINGS
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] In accordance with the present disclosure, an adjustable band (hereinafter interchangeably referred to as band) for obesity reduction is disclosed. A target site for deploying the adjustable band may include, without limitation, around the external walls of a patient’s stomach. The adjustable band may be placed around the upper part of stomach. The adjustable band constricts the stomach by clamping a portion of the stomach, and dividing it into two separate pouches. This reduces the size of the stomach, and also slows the movement of food through the stomach, thereby inducing the feeling of fullness with a lesser food intake.
[0022] According to the teachings of the present disclosure, the adjustable band has multiple size options and may be connected at any one of the multiple size options based upon requirements. In other words, the size of the proposed band is adjustable. The adjustability of the proposed band gives a surgeon the flexibility to customize the adjustable band according to individual patient’s needs, thereby obtaining optimal results for the patient. Since a single band according to the teachings of the present disclosure 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 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 band make the overall implantation procedure more efficient.
[0023] Referring now to the figures, Fig. 1a shows a perspective view of an adjustable band 100 (hereinafter, band 100) for obesity reduction and Fig. 1b shows an exploded view of the band 100, according to one embodiment. According to an embodiment, the band 100 is designed in the form of an adjustable ring such that a circumferential size of the band 100 may be adjusted by a surgeon as required depending upon a patient’s anatomy. In an embodiment, the band 100 includes a base segment 150, a male connector 140, and a female connector 110. The band 100 may be prefabricated and calibrated. Further, in an embodiment, the band 100 may be coated with sterilized silicon.
[0024] The base segment 150 acts as a support for one or more components of the band 100. The base segment 150 has a first end 150a and a second end 150b. In an embodiment, the base segment 150 is in the shape of a circular arc. The base segment 150 may have a pre-defined cross-section, for example, rectangular, circular, square, etc. In an exemplary implementation, the base segment 150 has a rectangular cross-section. The rectangular cross-section of the base segment 150 enables a flat contact patch with the stomach, thereby reducing pressure on the walls of the stomach. The base segment 150 may be made of a biocompatible material, for example, silicone, titanium, polyethylene, etc. In an exemplary implementation, the base segment 150 is made of radiopaque silicone. The base segment 150 may be solid or hollow. In the depicted embodiment, the base segment 150 is solid.
[0025] The male connector 140 is coupled to the base segment 150 at the second end 150b of the base segment 150. The male connector 140 may be coupled to the base segment 150 using a coupling technique, such as, without limitation, adhesive bonding, heat sealing, chemical bonding, etc. In an example implementation, a first end of the male connector 140 is coupled to the second end 150b of the base segment 150 using adhesive bonding. In another example implementation, the male connector 140 is integrally coupled to the base segment 150. In an embodiment, the male connector 140 is in the shape of a circular arc. The male connector 140 may be made of a biocompatible material, such as, without limitation, polyurethane, titanium, stainless steel, etc. In an example implementation, the male connector 140 is made of polyurethane. The male connector 140 generally has a rectangular cross-sectional shape, according to an embodiment.
[0026] The male connector 140 is configured to mate with the female connector 110, thereby configuring the band 100 in the closed state. In an embodiment, the male connector 140 includes a pair of protrusions 142 (hereinafter, protrusions 142) provided on either side of the male connector 140. The protrusions 142 are configured to mate with respective coupling structures of the female connector 110 as explained later. The protrusions 142 may be compressible such that in response to an application of pressure, the protrusions 142 are compressed and in response to releasing the pressure, the protrusions 142 regain original shape. This enables inserting the protrusions 142 in the female connector 110 and locking the protrusions 142 with the female connector 110.
[0027] The female connector 110 is coupled to the base segment 150 at the first end 150a of the base segment 150. The female connector 110 may be coupled to the base segment 150 using a coupling technique, such as, without limitation, adhesive bonding, heat sealing, chemical bonding, etc. In an example implementation, a first end of the female connector 110 is coupled to the first end 150a of the base segment 150 using adhesive bonding. In another example implementation, the female connector 110 is integrally coupled to the base segment 150. In an embodiment, the female connector 110 is in the shape of a circular arc such that when the female connector 110 and the male connector 140 mate with each other, the base segment 150, the female connector 110 and the male connector 140 form a circular ring. The female connector 110 may be made of a biocompatible material, such as, without limitation, polyurethane, titanium, stainless steel, etc. In an example implementation, the female connector 110 is made of polyurethane. The female connector 110 has the same cross-sectional shape as that of the base segment 150. In an embodiment, the female connector 110 has a tubular structure, defining a cavity. The cavity is configured to receive at least a portion of the male connector 140 when the female connector 110 mates with the male connector 140. The female connector 110 includes two or more pairs of ports 170a – 170d (collectively, referred to as ports 170) provided on either side of the female connector 110 and arranged along a length of the female connector 110 as depicted in Fig. 2. Each of the ports 170 is configured to receive and mate with a corresponding protrusion 142 of the protrusions 142. The ports 170 are complementary to the protrusions 142. In an embodiment, the protrusions 142 and the ports 170 form a snap-fit lock. Each pair of the two or more pairs of ports 170a – 170d corresponds to a size option of a plurality of size options of the band 100. For example, the pairs of ports 170a, 170b, 170c and 170d may correspond to a first size option, a second size option, a third size option and a fourth size option, respectively. During a medical procedure, the protrusions 142 may be locked with any one of the pairs of ports 170a – 170d as per desired size option, thereby adjusting the size of the band 100 depending upon a patient’s anatomy. According to an embodiment, the first size option, the second size option, the third size option and the fourth size option correspond to 7.5 cm, 7 cm, 6.5 cm and 6 cm, respectively. Though Fig. 2 shows the female connector 110 including four pairs of ports 170a – 170d, thereby realizing four size options, it should be considered merely as an example. The number of pairs of ports 170 on the female connector 110 may vary depending upon requirements.
[0028] Fig. 3a illustrates the band 100 in an open state. In the open state, the female connector 110 and the male connector 140 are uncoupled from each other. The open state enables a surgeon to wrap the band 100 around a patient’s stomach during a medical procedure. In the closed state, the female connector 110 and the male connector 140 are coupled to each other such that the band 100 forms a ring as shown in Fig. 3b. Further, in the closed state, a portion of the male connector 140 towards the second end of the male connector 140 is disposed within the female connector 110 and the protrusions 142 are engaged with one pair of the pairs of ports 170a – 170d based upon requirements.
[0029] According to an embodiment, the band 100 includes a slider 130 (shown in Fig. 1a – 1b) configured to unlock the female connector 110 and the male connector 140 (e.g., unlock the protrusions 142 from the respective pair of ports 170). The slider 130 has a hollow, tubular structure having, for example, a rectangular cross-section. According to an embodiment, the slider 130 is disposed over or encompasses a portion of the base segment 150 and is slidably coupled to the base segment 150 and the female connector 110. The slider 130 is configured to slide over at least a partial length of the base segment 150 and the female connector 110. To unlock the female connector 110 and the male connector 140, the slider 130 is slid over the female connector 110 until a location where the protrusions 142 are coupled with one of the pairs of ports 170. The sliding direction of the slider 130 for unlocking the band 100 is indicated in Fig. 4. When the slider 130 contacts the protrusions 142, inner surface of the slider 130 applies pressure on the protrusions 142, causing the protrusions 142 to be compressed and unlock (or disengage) from the corresponding pair of ports, i.e., one of the pairs of ports 170a – 170d. The male connector 140 may then be pulled out from the female connector 110. The slider 130 may optionally include at least one slot 132 provided on a bottom surface of the slider 130. The at least one slot 132 facilitates smooth and precise sliding movement of the slider 130 as explained later. In an example implementation, the slider 130 includes one slot 132 shown in Fig. 1a. The slider 130 may be made of a biocompatible material, such as, without limitation, polyurethane, medical grade plastic, polymer composite, etc. In an exemplary implementation, the slider 130 is made of polyurethane.
[0030] In an embodiment, the band 100 may further include a support member 120. The support member 120 is disposed towards an inner circumference of the base segment 150. The support member 120 is tubular and has an opening provided towards an outer circumferential side of the support member 120 and extending along the entire length of the support member 120, thereby defining a channel 122. The slider 130 is coupled to the support member 120. For example, the slider 130 is press-fitted within the support member 120. The channel 122 is configured to receive the slider 130 and the female connector 110. The slider 130 is slidable within the channel 122. The dimensions of the support member 120 are designed such that the slider 130 to enable the slider 130 to slide over the female connector 110 fully. In an embodiment, the support member 120 may include at least one guide rail 124 provided along the length of the channel 122. Each of the at least one guide rail 124 is configured to fit within a corresponding slot 132 of the at least one slot 132. In other words, each slot 132 of the at least one slot 132 is configured to receive a portion of a corresponding one of the at least one guide rail 124 of the support member 120. When the slider 130 slides, each slot 132 of the at least one slot 132 slides over the corresponding guide rail 124 of the at least one guide rail 124. Thus, the at least one guide rail 124 provides a path for the slider 130 and facilitates easy and precise sliding movement of the slider 130. In the depicted embodiment, the support member 120 includes one guide rail 124. The support member 120 may be made of a biocompatible material, such as, without limitation, polyurethane, medical grade plastic, polymer composite, etc. In an exemplary implementation, the support member 120 is made of polyurethane.
[0031] According to an embodiment, the support member 120 includes a plurality of indicators 126a – 126d (collectively referred to as indicators 126) provided on an outer surface of the support member 120 as shown in Fig. 2. Each of the indicators 126 is aligned with a respective pair of the ports 170. For example, the indicators 126a – 126d are aligned with the pairs of ports 170a – 170d, respectively. Each of the indicators 126 indicates a size (e.g., in cm) of the band 100 corresponding to a size option of the plurality of size options. For example, the indicator 126a indicates a size of the first size option, the indicator 126b indicates a size of the second size option, the indicator 126c indicates a size of the third size option and the indicator 126d indicates a size of the fourth size option. The indicators 126 visually assist a surgeon to couple the male connector 140 with the female connector 110 at an appropriate pair of ports (e.g., one of the pairs of ports 170a – 170d) of the ports 170 to achieve a desired size of the band 100 as per requirements. The number of indicators 126 corresponds to the number of size options (or the number of pairs of ports 170) provided within the band 100 and may be designed based upon requirements.
[0032] Though the present disclosure has been explained with the male connector 140 and the female connector 110 having the pair of protrusions 142 and the pairs of ports 170a – 170d, respectively, it should not be considered as limiting. In various embodiment, the female connector 110 may include a plurality of female coupling structures and the male connector 140 may include a male coupling structure configured to mate with the plurality of female coupling structures. Each of the plurality of female couplings structures may be disposed at a respective position along a length of the female connector 110, each position representing a corresponding size option of a plurality of size options. The male coupling structure may be configured to removably couple with the plurality of female coupling structures such that in the closed position, the male coupling structure is coupled with one of the plurality of female coupling structures. This enables adjusting the size of the band 100. Further, the male coupling structure may be configured to disengage from the said one of the plurality of female coupling structures in response to the slider 130 sliding over the female connector 110 in a similar manner as explained earlier, thereby unlocking the male connector 140 from the female connector 110. Further, each indicator (126a – 126d) of the indicators 126 is aligned with a corresponding female coupling structure of the plurality of female coupling structures. According to the depicted embodiment, the male coupling structure of the male connector 140 includes the pair of protrusions 142 and the female coupling structure of the female connector 110 includes the two or more pairs of ports 170a – 170d, wherein each pair of ports 170a – 170d is configured to receive the pair of protrusions 142.
[0033] Fig. 6 illustrates a flowchart of a method 200 for using the band 100, according to an embodiment of the present disclosure. The band 100 may be implanted in the patient’s body via a laparoscopic surgery.
[0034] At step 201, one or more surgical cuts are made in the patient’s abdomen to create an access to the patient’s stomach.
[0035] At step 202, the band 100 is inserted and wrapped around the patient’s stomach at a required location, e.g., an upper part of the stomach. The band 100 is in the unlocked state at this stage.
[0036] At step 203, the male connector 140 is locked with the female connector 110 at a required size. The required size is chosen by the surgeon based upon the patient’s anatomy. To lock the male connector 140 with the female connector 110, the second end of the male connector 140 is inserted into the female connector 110. The second end of the male connector 140 is pushed into the female connector 110 until the protrusions 142 align with one of the pairs of ports 170a – 170d corresponding to the required size. For example, the protrusions 142 are aligned with the pair of ports 170a to achieve the size of 7.5 cm. Similarly, the protrusions 142 are aligned with the pairs of ports 170b, 170c and 170d to achieve the size of 7 cm, 6.5 cm and 6 cm, respectively. Upon the alignment, the male connector 140 is released so that the protrusions 142 regain original shape and lock with the said pair of ports 170a – 170d, thereby setting the band 100 in the locked state. Figs. 5a, 5b and 3b depict the band 100 connected to the size of 7.5 cm, 7 cm, and 6.5 cm, respectively.
[0037] At step 204, the slider 130 is moved towards the female connector 110 to unlock the band 100. This may be done either for readjusting the size of the band 100 or for removing the band 100 from the patient’s body. The slider 130 slides within the support member 120 over the base segment 150 and the female connector 110. When the slider 130 moves over the female connector 110, the slider 130 applies force on the protrusions 142, causing the protrusions 142 to be compressed and unlock from the said pair of ports of the pairs of ports 170a – 170d. Once the band 100 is unlocked, steps 202 – 203 may be followed to readjust the size of the band 100 as needed.
[0038] The proposed adjustable band presents several advantages. For example, the use of the proposed adjustable 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 adjustable 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 adjustable 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 adjustable band of the present disclosure is easily removable and has enhanced usability compared to conventional gastric band.
[0039] 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. An adjustable band (100) for obesity reduction, the adjustable band (100) comprising:
a. a base segment (150) having a first end (150a) and a second end (150b);
b. a female connector (110) coupled to the base segment (150) at the first end (150a) of the base segment (150), the female connector (110) comprising a plurality of female coupling structures, each female coupling structure disposed at a respective position along a length of the female connector (110), each position representing a corresponding size option of a plurality of size options;
c. a male connector (140) coupled to the base segment (150) at the second end (150b) of the base segment (150), the male connector (140) comprising a male coupling structure configured to removably couple with the plurality of female coupling structures;
d. wherein in a closed position, the male coupling structure of the male connector (140) is coupled to one of the plurality of female coupling structures of the female connector (110).
2. The adjustable band (100) as claimed in claim 1, wherein the male coupling structure of the male connector (140) comprises a pair of protrusions (142) and the female coupling structure of the female connector (110) comprises two or more pairs of ports (170a, 170b, 170c, 170d), each pair of ports (170a, 170b, 170c, 170d) configured to receive the pair of protrusions (142).
3. The adjustable band (100) as claimed in claim 1, wherein the base segment (150), the female connector (110) and the male connector (140) have a rectangular cross-section.
4. The adjustable band (100) as claimed in claim 1, wherein the adjustable band (100) comprises a slider (130) encompassing a portion of the base segment (150) and configured to slide over the female connector (110) and unlock the male connector (140) and the female connector (110)
5. The adjustable band (100) as claimed in claim 4, wherein in response to the slider (130) sliding over the female connector (110), the male coupling structure of the male connector (140) is configured to disengage from said one of the plurality of female coupling structures of the female connector (110), thereby unlocking the male connector (140) from the female connector (110).
6. The adjustable band (100) as claimed in claim 4, wherein the adjustable band (100) comprises a support member (120) coupled to the slider (130), the support member (120) having a channel (122) configured to receive the slider (130) and the female connector (110), wherein the slider (130) is slidable within the channel (122).
7. The adjustable band (100) as claimed in claim 6, wherein the slider (130) comprises at least one slot (132), each slot (132) of the at least one slot (132) is configured to receive a portion of one of at least one guide rail (124) provided along a length of the channel (122) of the support member (120).
8. The adjustable band (100) as claimed in claim 6, wherein the support member (120) comprises a plurality of indicators (126), each indicator (126a, 126b, 126c, 126d) aligned with a corresponding female coupling structure of the plurality of female coupling structures of the female connector (110) and indicating a corresponding size of the gastric sculpture band (100).