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:
DEVICE FOR REDUCING GASTROESOPHAGEAL REFLUX
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] Present disclosure relates to medical devices. More particularly, the present disclosure relates to a device for reducing gastroesophageal reflux.
BACKGROUND OF INVENTION
[002] Gastroesophageal Reflux Disease (GERD) is a common gastroesophageal disorder in which contents of a patient’s stomach flow back into the patient’s esophagus. It is caused due to poor closure of the lower esophageal sphincter (LES), which is at the junction of the esophagus and the stomach. The stomach contents are highly acidic and cause heartburn in the patient. Other symptoms associated with GERD include chest pain, regurgitation, dental corrosion and the like.
[003] Fundoplication is the most common surgical procedure for treating GERD. In this procedure, the top part of the patient’s stomach (i.e., the fundus) is folded and sewn around the LES to reinforce the closure capability of the LES. However, the patient may experience discomfort of pain during or after the procedure. Also, the recovery time may be longer. Further, the patient may suffer from complications (e.g., infection) arising due to the surgery.
[004] Balloon catheter-based devices are currently available to treat GERD in a minimally manner. These devices transmit radiofrequency pulses into the muscles of the LES with the help of needles. The needles are coupled to the balloon provided at a distal end of the catheter. Once the catheter reaches a desired location, the balloon is inflated and the needles are pushed into muscles of the LES.
[005] However, such conventional devices suffer from multiple drawbacks. The range of distances between the needles and the tissue for which the conventional device can be used is constrained by the size of the inflated balloon. Balloon based catheters are expensive, which increases the cost of the conventional device. Further, since the balloon needs to be inflated and deflated during the procedure, the overall time for the procedure is more and may increase the patient’s discomfort.
[006] Hence, there arises a need of a device for treating GERD which overcomes the problems related to conventionally available devices.
SUMMARY OF INVENTION
[007] 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.
[008] The present disclosure relates to a device for reducing gastroesophageal reflux. In an embodiment, the device includes a catheter shaft, a support element, a pusher rod, a plurality of arms and a plurality of electrodes. The support element is provided at a distal end of the device. The pusher rod is partially disposed within the catheter shaft such that a proximal end of the pusher rod extends out of the catheter shaft in a proximal direction and a distal end of the pusher rod is disposed distal to a distal end of the catheter shaft. Each arm of the plurality of arms includes a first portion at least partially disposed within the catheter shaft, a second portion disposed within and fixedly coupled to the support element, and a third portion disposed between the catheter shaft and the support element. The third portion is coupled to the pusher rod and is configured to radially expand in response to the pusher rod being pushed in a distal direction. The plurality of electrodes is electrically coupled to an excitation source. Further, each of the plurality of electrodes is coupled to the third portion of a respective arm of the plurality of arms. The plurality of electrodes is configured to anchor within muscle tissues in the lower esophageal sphincter (LES). In a deployed state, the third portions of the plurality of arms are radially expanded, and the plurality of electrodes are configured to receive an excitation signal from the excitation source and provide the excitation signal to the muscle tissues in the LES.
BRIEF DESCRIPTION OF THE DRAWING
[009] 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.
[0010] Fig. 1 depicts a perspective view of a device 100 for reducing gastroesophageal reflux, according to an embodiment of the present disclosure.
[0011] Fig. 2a depicts a perspective view of a distal portion of the device 100 showing an expandable assembly 130, according to an embodiment of the present disclosure.
[0012] Fig. 2b depicts a cross-sectional view of the device 100, according to an embodiment of the present disclosure.
[0013] Fig. 3a depicts a perspective view of a proximal portion of the device 100, according to an embodiment of the present disclosure.
[0014] Fig. 3b depicts a cross-sectional view of the proximal portion of the device 100, according to an embodiment of the present disclosure.
[0015] Fig. 3c depicts an exploded view of a locking assembly, according to an embodiment of the present disclosure.
[0016] Fig. 4 depicts a flowchart of a method 400 of using the device 100, according to an embodiment of the present disclosure.
[0017] Fig. 4a illustrates the distal portion of the device 100 showing an expandable assembly 130 in a collapsed state, according to an embodiment of the present disclosure.
[0018] Figs. 4b – 4c illustrate the distal portion of the device 100 showing the expandable assembly 130 in an expanded state
DETAILED DESCRIPTION OF THE DRAWINGS
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] The present disclosure relates to a device for treating Gastroesophageal Reflux Disease (GERD). In an embodiment, the device includes an expandable assembly having plurality of arms (or arms) and a plurality of electrodes (or electrodes) coupled to the arms, and a pusher rod. The electrodes deliver excitations signals to muscle tissues in the lower esophageal sphincter (LES) to help in restoring the functionality of the LES. The arms are radially expanded using the pusher rod, causing the electrodes to pierce the muscle tissues. The proposed device overcomes challenges associated with conventional devices that move the electrodes into the muscle tissues by inflating a balloon. For example, since the proposed device is not constrained by the size of the balloon, the proposed device enables a surgeon to use the device over a maximal range of distances between the electrodes and the muscle tissues. Further, the proposed device prevents a need for inflating/deflating a balloon. Therefore, overall procedural complexity and time are reduced. Also, the proposed device decreases the cost of the device and the medical procedure since no balloon is required.
[0024] Referring now to the figures, Fig. 1 depicts a perspective view of a device 100 for reducing gastroesophageal reflux, according to an embodiment of the present disclosure. The gastroesophageal reflux may be caused by Gastroesophageal Reflux Disease (GERD). The device 100 has a proximal end 100a and a distal end 100b. In an embodiment, the device 100 includes a handle 110, a pusher rod 150, a catheter shaft 120, an expandable assembly 130, and a support element 140. In a deployed mode, the device 100 delivers excitation signals (e.g., radiofrequency (RF) pulses) to muscle tissues of the LES of a patient with the help of the expandable assembly 130. The excitation signals produce heat in the muscle tissues and cause to reshape the ring of muscles in the LES, restoring natural reflex barrier between the esophagus and the stomach.
[0025] The expandable assembly 130 is provided towards the distal end 100b of the device 100. The expandable assembly 130 is configured to be in a collapsed state and an expanded state. In the deployed mode of the device 100, the expandable assembly 130 is radially expanded and is set in the expanded state. The expandable assembly 130 facilitates the delivery of excitation signals at a target site as explained later. The pusher rod 150 enables a surgeon to control the expandable assembly 130 and set the expandable assembly 130 to the expanded state as needed during a medical procedure.
[0026] The catheter shaft 120 is used to navigate and position the expandable assembly 130 at the target site. The expandable assembly 130 disposed distal to the catheter shaft 120. The handle 110 is provided at the proximal end 100a of the device 100 and is coupled to the catheter shaft 120. The handle 110 enables a surgeon to hold the device 100.
[0027] As explained earlier, the expandable assembly 130 helps to deliver the excitation signals to the muscle tissues. Fig. 2a depicts a distal portion of the device 100 showing an exemplary expandable assembly 130 and Fig. 2b depicts a cross-sectional view of the device 100. In an embodiment, the expandable assembly 130 includes a plurality of electrodes 134 (hereinafter, electrodes 134) and a plurality of arms 132 (hereinafter, arms 132). The number of arms 132 and electrodes 134 may be varied based upon requirements. The number of arms 132 and the electrodes 134 may be two or more. In an embodiment, the number of arms 132 and the electrodes 134 may be between two to six. Preferably, the number of arms 132 and the electrodes 134 are between three to six. More preferably, the expandable assembly 130 includes four arms 132 and four electrodes 134 as in the depicted embodiment.
[0028] Each electrode 134 of the electrodes 134 is electrically coupled to an excitation source (not shown) via a corresponding wire 210 (shown in Fig. 3b). The electrodes 134 are configured to anchor within muscle tissues in the LES and are configured to provide the excitation signal received via the excitation source to the muscle tissues of the LES. In an embodiment, the excitation signal is a series of radiofrequency (RF) pulses having desired frequency and energy. According to an example implementation, the excitation signal may be a sinusoidal wave having frequency between 460 kHz to 470 kHz, amplitude of up to 80V at 100 Ohms – 800 Ohms and between 2W to 5W power delivered to each electrode 134. Each electrode 134 is coupled to a respective arm 132 of the arms such that the electrode 134 extends out from the corresponding arm 132 in a radially outward direction.
[0029] The electrodes 134 may have a pre-defined shape including, without limitation, needle, pyramid, cone, curved, cylinder, plate, rod, etc. In an example implementation, the electrodes 134 are shaped in the form of a needle. The electrodes 134 may be made of a biocompatible metal, such as, without limitation, titanium, stainless steel, platinum, etc. In an example implementation, the electrodes 134 are made of titanium. In an embodiment, the electrodes 134 may have a length ranging from 5 mm to 10 mm.
[0030] The arms 132 may be circumferentially disposed around a longitudinal axis of the expandable assembly 130. The arms 132 may be uniformly or non-uniformly distributed. In the depicted embodiment, the arms 132 are uniformly distributed. According to an embodiment, each arm 132 has a first portion 132a, a second portion 132b and a third portion 132c situated therebetween as depicted in Fig. 2b. The first portion 132a is situated towards a proximal end of the arm 132. The first portion 132a is at least partially disposed within the catheter shaft 120. In an embodiment, the first portion 132a is partially disposed within the catheter shaft 120 such that a proximal end of the first portion 132a extends out of the catheter shaft 120 and is disposed within the handle 110 (as shown in Fig. 3b). This allows for a proper electrical and mechanical coupling of the arms 132, the wires 210 with other components in the handle 110 and facilitates accurate transfer of power and excitation signals to the electrodes 134. The second portion 132b is situated towards a distal end of the arm 132. The second portion 132b is disposed within the support element 140 and is fixedly coupled to the support element 140. The second portion 132b of the arm 132 is coupled to the support element 140 using a coupling technique, such as, without limitation, welding, bonding, mechanical fastening, etc. In an example implementation, the second portion 132b of the arm 132 is coupled to the support element 140 using welding. The third portion 132c is disposed between the support element 140 and the catheter shaft 120. The third portion 132c is radially expandable and is configurable to be in a collapsed state or a radially expanded state. In the collapsed state, the third portion 132c may be substantially aligned with the longitudinal axis of the device 100. In the expanded state, the third portion 132c curves radially outward, thereby advancing the electrodes 134 towards the target tissue within the LES. By adjusting a degree of expansion of the third portions 132c and hence, of the arms 132, the distance between the electrodes 134 and the target tissue may be adjusted as per requirement during a medical procedure. In an embodiment, the length of the first portion 132a may be equal to or slightly longer than the length of the catheter shaft 120, and the length of the second portion 132b may range between 15 mm and 20 mm. Similarly, in an embodiment, the length of the third portion 132c may range between 70 mm and 80 mm.
[0031] Each electrode 134 is coupled to third portion 132c of the respective arm 132. In an embodiment, each arm 132 includes an opening provided on the third portion 132c. A proximal end of the corresponding electrode 134 is disposed within the opening. The proximal end of the electrode 134 is coupled to the third portion 132c of the corresponding arm 132 using a technique, such as, without limitation, welding, adhesive bonding, mechanical crimping, etc. In an example implementation, the proximal end of the electrode 134 is coupled to the third portion 132c of the arm 132 using adhesive bonding. Further, according to an embodiment, each arm 132 has a tubular structure defining a lumen configured to receive the corresponding wire 210 coupled to the respective electrode 134. In other words, the arms 132 act as conduits for the wires 210 such that each wire 210 is disposed within the lumen of the corresponding arm 132. The arms 132 may have a pre-defined cross-sectional shape including, but not limited, circular, rectangular, triangular, etc. In an example implementation, the arms 132 have a circular cross-section. The arms 132 may be made of a material, such as, without limitation stainless steel, titanium, nitinol, etc. In an embodiment, the arm 132 are made of stainless steel.
[0032] According to an embodiment, the pusher rod 150 is configured to move the third portions 132c of the arms 132 (and hence, the expandable assembly 130) from the collapsed state to the radially expanded state and vice versa. The pusher rod 150 is partially disposed with the catheter shaft 120. In an embodiment, a portion of the pusher rod 150 is disposed within the catheter shaft 120 and the handle 110 such that a proximal end of the pusher rod 150 extends out of the catheter shaft 120 in a proximal direction the handle 110 and a distal end of the pusher rod 150 is disposed distal to a distal end of the catheter shaft 120. In an embodiment, the proximal end of the pusher rod 150 extends out of the handle 110. The pusher rod 150 is coupled to the arms 132. According to an embodiment, the pusher rod 150 is coupled to the third portion 132c of each arm 132 with the help of a respective connector 136 of a plurality of connectors 136 (hereinafter, connectors 136). Each connector 136 has a first end and a second end. The first end of each connector 136 is fixedly coupled to the third portion 132c of the corresponding arm 132 using, for example, soldering, though any other coupling technique may be used. The first end of the connector 136 may be coupled to the third portion 132c at a desired location. In an embodiment, the first end of the connector 136 is coupled to the third portion 132c at or around a mid-point of the length of the third portion 132c. This enables even expansion of the third portion 132c and hence, of the expandable assembly 130. The second end of each connector 136 is operatively coupled to the pusher rod 150. In an embodiment, the second end of each connector 136 is coupled to a disc 138 using, for example, adhesive bonding, though any other coupling technique may be used. The disc 138 is coupled to the pusher rod 150 using a coupling technique, such as, without limitation, welding, adhesive bonding, mechanical fastening, etc. In an example implementation, the disc 138 is coupled to the distal end of the pusher rod 150 using welding. The coupling of the connectors 136 to the pusher rod 150 via the disc 138 facilitates a controlled and synchronized expansion of the third portions 132c, ensuring accurate positioning of the electrodes 134 during a medical procedure. In another embodiment, the second end of each connector 136 may be directly coupled to the distal end of the pusher rod 150 using, for example, welding, adhesive bonding, mechanical fastening, etc. Further, at least a partial length of the first portion 132a of each arm 132 is coupled to the pusher rod 150. In an embodiment, the length of the first portion 132a of each arm 132 within the catheter shaft 120 is fixedly coupled to the pusher rod 150 using adhesive bonding, though any other coupling technique may be used.
[0033] The pusher rod 150 may be pushed or pulled by the surgeon based upon requirements. In response to the pusher rod 150 being pushed in a distal direction, the third portion 132c of each arm 132 is configured to radially expand. When the pusher rod 150 is pushed in the distal direction, the distal end of the pusher rod 150 moves in the distal direction and each connector 136 pushes out the respective third portion 132c, causing the third portion 132c of the corresponding arm 132 to radially curve outwards to be in the expanded state. The more the pusher rod 150 is pushed, the more is the radial expansion of the arms 132. Thus, by controlling how far the pusher rod 150 is pushed, the surgeon is able to control the radial expansion of the arms 132 and hence, the position of the electrodes 134 precisely. Similarly, when the pusher rod 150 is pulled in a proximal direction, each connector 136 pulls the correspond third portion 132c towards the longitudinal axis of the expandable assembly 130, thereby radially contracting the arms 132. The range of the device 100 may be defined by the maximum expansion diameter of the third portions 132c of the arms 132. In an embodiment, the range of the device 100 may be at least 35 mm. In another embodiment, the range of the device 100 may be between 35 mm and 40 mm. Thus, as compared to conventional balloon-based devices, which typically have a range of up to 30 mm, the device 100 has a significantly wider range. Further, the wider range enables the device 100 to have an overall smaller profile (e.g., the outer diameter of the catheter shaft 120) compared to conventional balloon-based devices. Consequently, the device 100 results in reduced trauma to the patients.
[0034] The pusher rod 150 may be made of a biocompatible material, such as, without limitation, stainless steel, titanium, polymer composites, etc. In an example implementation, the pusher rod 150 may be made of titanium. The pusher rod 150 may have a pre-defined cross-sectional shape, such as, without limitation, circular, triangular, hexagonal, oval, square, rectangular, etc. In an example implementation, the pusher rod 150 has a circular cross-section. In an embodiment, the connectors 136 may be made of a more rigid material as compared to the material used to make the arms 132. This facilitates the transfer of force applied by the pusher rod 150 to the arms 132 without bending the connectors 136. The connectors 136 may be made of a biocompatible material, such as, without limitation, stainless steel, titanium, polymer composites, etc. In an example implementation, the connectors 136 are made of titanium. The disc 138 may be made of a biocompatible material, such as, without limitation, polyethylene, silicone, polyurethane, etc. In an example implementation, the disc 138 is made of polyethylene.
[0035] Referring back to Fig. 1, the catheter shaft 120 is coupled to the handle 110. The catheter shaft 120 has an elongated, tubular structure. The catheter shaft 120 includes a first lumen (not shown) configured to receive the pusher rod 150 and the first portions 132a of the arms 132. The catheter shaft 120 may have a length ranging between 150 mm and 300 mm. The catheter shaft 120 may have an outer diameter ranging between 4 mm and 7 mm. In an example implementation, the length and the outer diameter of the catheter shaft 120 are 200 mm and 5 mm, respectively. The catheter shaft 120 may be made of a biocompatible material, such as, without limitation, polyurethane, silicone, polyamide, etc. In an example implementation, the catheter shaft 120 is made of polyurethane. The catheter shaft 120 may also include a plurality of second lumens provided circumferentially about the first lumen. Each second lumen is configured to receive the first portion 132a of the corresponding arm 132. The first lumen and the plurality of second lumens may extend from the proximal end of the catheter shaft 120 to a pre-defined distance from the distal end of the catheter shaft 120. In an embodiment, the pre-defined distance may range between 30 mm and 60 mm. Such a design allows for controlled and guided movement of the arms 132 and the pusher rod 150, easier assembly of the device 100 and accurate alignment of the arms 132 and the pusher rod 150 with respect to each other, while providing more streamlined and flexible design at the distal end of the catheter shaft 120 for facilitating easier navigation through the patient’s body with minimal trauma to the patient and allowing access target areas without additional obstructions.
[0036] The support element 140 is provided at the distal end 100b of the device 100. The support element 140 facilitates navigation of the catheter shaft 120 through a patient’s body and helps to prevent trauma to the patient’s tissues during the navigation. The support element 140 is generally cylindrical. In an embodiment, the support element 140 has a tapered shape towards a distal end of the support element 140. The tapered shape of the support element 140 minimizes the trauma to surrounding tissues during the navigation of the catheter shaft 120. The support element 140 is coupled to the arms 132. In an embodiment, the support element 140 includes a plurality of apertures (not shown). Each aperture of the plurality of apertures is configured to receive and couple with the second portion 132b of the corresponding arm 132. The support element 140 may be made of a soft, biocompatible material, such as, without limitation, silicone, polyurethane, elastomeric materials, etc. In an example implementation, the support element 140 is made of silicon. In an embodiment, the length of the support element 140 may range between 20 mm and 40 mm.
[0037] Fig. 3a depicts a perspective view of a proximal portion of the device 100 showing an exemplary handle 110 and Fig. 3b depicts a cross-sectional view of the proximal portion of the device 100. The handle 110 encloses a space and houses various components or portions thereof of the device 100. The handle 110 is coupled to the catheter shaft 120. A distal end of the handle 110 may be coupled to a proximal end of the catheter shaft 120 using a technique, such as, without limitation, adhesive bonding, mechanical fastening, welding, etc. In an example implementation, the distal end of the handle 110 is coupled to the proximal end of the catheter shaft 120 using mechanical fastening. In an embodiment, the handle 110 may be formed using a left section 110a and a right section 110b coupled together using, for example, a snap-fit mechanism, though any other coupling technique may be used to couple the left section 110a and the right section 110b together. The left section 110a and the right section 110b may be made of a material, such as, without limitation, thermoplastic, aluminum, stainless steel, etc. In an example implementation, the left section 110a and the right section 110b are made of a thermoplastic material. The handle 110 may be designed to have an ergonomic shape so that the surgeon may hold the handle 110 easily. In an embodiment, the handle 110 may be provided with an indented portion 110c to allow for a better and easy grip by the surgeon.
[0038] In an embodiment, the handle 110 includes an extended portion 111 provided at a top side of the handle 110. The extended portion 111 has a tubular structure defining an opening. The opening is configured to receive a portion of the pusher rod 150. The pusher rod 150 may be disposed such that a section of the pusher rod 150 is disposed within a first channel (not shown) provided in the handle 110. The first channel extends from a proximal end of the extended portion 111 to the distal end of the handle 110. The first channel may have an elbow shape. Accordingly, the portion of the pusher rod 150 disposed within the channel may also have an elbow shape as seen in Fig. 3b. The proximal end of the pusher rod 150 extends out of the extended portion 111 of the handle 110. A grip 152 may be coupled to the proximal end of the pusher rod 150. The grip 152 allows the surgeon to hold and manipulate the pusher rod 150 easily.
[0039] According to an embodiment, a locking assembly may be provided with the handle 110, for example, in the extended portion 111 of the handle 110. The locking assembly is configured to lock the pusher rod 150 and prevent any movement of the pusher rod 150 once the surgeon has moved the pusher rod 150 to a desired position. An exploded view of an exemplary locking assembly is depicted in Fig. 3c. In the depicted embodiment, the locking assembly forms an iris mechanism and includes a sleeve 112, a plurality of plates 113, a first disc 115, a second disc 116 and a tab 114. The first disc 115 includes a plurality of first slots 115a and the second disc 116 includes a plurality of second slots 116a. Each of the plurality of plates 113 includes a pin 113a. The first disc 115, the plurality of plates 113 and the second disc 116 are disposed within the sleeve 112. The first disc 115 is situated towards a top end of the sleeve 112, the second disc 116 is situated towards a bottom end of the sleeve 112 and the plurality of plates 113 are positioned between the first disc 115 and the second disc 116. The first disc 115 and the second disc 116 are circular. The plurality of first slots 115a and the plurality of second slots 116a may be straight or curved. In the depicted embodiment, the plurality of first slots 115a and the plurality of second slots 116a are straight. The number of first slots 115a and the second slots 116a are equal to the number of plates 113. The number of plates 113 may be chosen based upon requirements. In an embodiment, the plates 113 have a tear-drop shape, though the plates 113 may have any other shape. A first end of each pin 113a is disposed with a corresponding first slot 115a and a second end of the pin 113a is disposed within a corresponding second slot 116a. The pins 113a move within the respective first slots 115a and the second slots 116a in response to the rotation of the first disc 115. The tab 114 is provided on the periphery of the first disc 115 and is rotatable by the surgeon. The sleeve 112 includes a slot 112a. A portion of the tab 114 is disposed within the slot 112a of the sleeve 112 and the remaining portion of the tab 114 extends out of the sleeve 112 so that the surgeon is able to hold and manipulate the tab 114. The plurality of plates 113 defines a central aperture configured to receive the pusher rod 150. The plurality of plates 113 are configured to move radially in response to the rotation of the tab 114. The plurality of plates 113 moves radially inwards or outwards depending upon the direction of the rotation of the tab 114. In an embodiment, in response to rotating the tab 114 in a first pre-defined direction (e.g., clockwise), the first disc 115 rotates in the first pre-defined direction and in response to the rotation of the first disc 115 in the first pre-defined direction, each pin 113a move radially inward within the respective first slots 115a and the second slots 116a, causing the plurality of plates 113 move radially inwards and grip the pusher rod 150, thereby locking the pusher rod 150. To unlock the pusher rod 150, the tab 114 is rotated in a second pre-defined direction (e.g., anticlockwise). In response to rotating the tab 114 in the second pre-defined direction, the plurality of plates 113 move radially outward, causing the aperture defined by the plurality of plates 113 to increase and the pusher rod 150 is unlocked. It should be understood that the locking assembly in the form of an iris mechanism disclosed herein is merely exemplary. Other structures of the locking assembly configured to lock the pusher rod 150 are also contemplated herein and are within the scope of the present disclosure.
[0040] Referring back to Fig. 3b, the handle 110 may include a plurality of second channels (not shown), with each second channel configured to receive and couple with the proximal end of the first portion 132a of the corresponding arm 132 that extends out of the catheter shaft 120. In other words, the proximal end of the first portion 132a of each arm 132 resides within the corresponding second channel. Further, according to an embodiment, the device 100 may include a switching element 117 provided in the handle 110 and electrically coupled to the wires 210. The switching element 117 is further electrically coupled to an excitation source (e.g., an RF pulse generator) via an electrical cable 200. The switching element 117 is configured to electrically connect and disconnect the excitation source from the electrodes 134. Upon activating and deactivating the switching element 117, the switching element 117 may electrically connect and disconnect the electrical cable 200 with the wires 210, respectively. In an embodiment, the switching element 117 may be a push button switch. The switching element 117 may reside within a depression 118 provided on the top side of the handle 110.
[0041] In an embodiment, an opening 119 is provided at the proximal end of the handle 110. The opening 119 provides a passage for the electrical cable 200 to exit the device 100. The electrical cable 200 is further electrically connected to the excitation source.
[0042] The device 100 is configured to be in an undeployed state and a deployed state. In the undeployed state, the third portions 132c of the arms 132 (and the expandable assembly 130) are radially collapsed, i.e., are in a radially collapsed state, and the electrodes 134 may be disconnected from the excitation source (e.g., by disconnecting the electrical cable 200 from the excitation source). In the deployed state, the third portions 132c of the arms 132 (and the expandable assembly 130) are radially expanded, i.e., are in a radially expanded state. Further, in the deployed state, the electrodes 134 are connected to the excitation source and are configured to receive an excitation signal from the excitation source and provide the excitation signals to the muscle tissues in the LES.
[0043] Fig. 4 illustrates a flowchart of a method 400 for using the device 100 for treating GERD, according to an embodiment.
[0044] At step 401, the distal end 100b of the device 100 is inserted into a patient’s body through a desired location, e.g., the patient’s mouth.
[0045] At step 402, the catheter shaft 120 is navigated to the lower esophageal sphincter (LES) via the esophagus. The expandable assembly 130 is in the collapsed state at this stage as shown in Fig. 4a.
[0046] At step 403, upon reaching the target site, the pusher rod 150 is pushed in the distal direction. The pusher rod 150 may be unlocked by rotating the tab 114 in the second pre-defined direction before pushing the pusher rod 150. When the pusher rod 150 is pushed, the third portions 132c of the arms 132 radially expand as explained earlier. As a result, the electrodes 134 move closer to the target tissues in the LES. The level of expansion of the arms 132 depends upon how far the pusher rod 150 is pushed in the distal direction. The distance between the electrodes 134 and the target tissues may be set to a desired value by controlling the pusher rod 150 as desired. Figs. 4b and 4c depict the expandable assembly 130 in the expanded state with two different exemplary levels of expansion. Once the desired position of the electrodes 134 is achieved, the pusher rod 150 is locked by rotating the tab 114 in the first pre-defined direction.
[0047] At step 404, the excitation source is connected to the electrical cable 200.
[0048] At step 405, the device 100 is activated by activating the switching element 117 (e.g., by pressing the switching element 117). The activation of the switching element 117 electrically connects the excitation source to the electrodes 134. The excitation signals are then delivered by the electrodes 134 to the target tissues. Due to the excitation pulse, heat is generated in the target tissues, causing the target muscles to resume their function of preventing the stomach acid from flowing back into the esophagus.
[0049] At step 406, once the desired outcome is reached, the device 100 is deactivated by deactivating the switching element 117.
[0050] At step 407, the catheter shaft 120 is retrieved from the patient’s body.
[0051] The teachings of the present disclosure present several advantages over conventional devices. For example, by obviating the need for a balloon, the proposed device is more cost-effective. Moreover, since the proposed device does not use a balloon, the proposed device eliminates the need for inflating/deflating steps. Consequently, the procedure is more efficient, user friendly and less time consuming compared to conventional devices. Further, the range of the proposed device is wider since the proposed device is no longer constrained by the size of an inflated balloon. The expandable assembly of the proposed device can be easily and precisely controlled by manipulating the pusher rod. This not only increases the accuracy and controllability of the proposed but also enhances the overall usability of the proposed device.
[0052] 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 device (100) for reducing gastroesophageal reflux, the device (100) comprising:
a. a catheter shaft (120);
b. a support element (140) provided at a distal end (100b) of the device (100);
c. a pusher rod (150) partially disposed within the catheter shaft (120) and having a proximal end extending out of the catheter shaft (120) in a proximal direction and a distal end disposed distal to a distal end of the catheter shaft (120);
d. a plurality of arms (132), each arm (132) comprising:
i. a first portion (132a) at least partially disposed within the catheter shaft (120);
ii. a second portion (132b) disposed within the support element (140) and fixedly coupled to the support element (140); and
iii. a third portion (132c) disposed between the catheter shaft (120) and the support element (140), the third portion (132c) is coupled to the pusher rod (150) and is configured to radially expand in response to the pusher rod (150) being pushed in a distal direction; and
e. a plurality of electrodes (134) electrically coupled to an excitation source, each of the plurality of electrodes (134) is coupled to the third portion (132c) of a respective arm (132) of the plurality of arms (132), the plurality of electrodes (134) is configured to anchor within muscle tissues in the lower esophageal sphincter (LES);
f. wherein, in a deployed state, the third portions (132c) of the plurality of arms (132) are radially expanded and the plurality of electrodes (134) are configured to receive an excitation signal from the excitation source and provide the excitation signal to the muscle tissues in the LES.
2. The device (100) as claimed in claim 1, wherein the device (100) comprises a disc (138) coupled to a distal end of the pusher rod (150) and a plurality of connectors (136), each connector (136) having a first end coupled to the third portion (132c) of a corresponding arm (132) and a second end coupled to the disc (138).
3. The device (100) as claimed in claim 1, wherein each electrode (134) is electrically coupled to the excitation source via a corresponding wire (210) disposed within a lumen of the corresponding arm (132).
4. The device (100) as claimed in claim 1, wherein the device (100) comprises a handle (110) provided at a proximal end (100a) of the device (100) and coupled to the catheter shaft (120), wherein the proximal end of the pusher rod (150) extends out of the handle (110) and a section of the pusher rod (150) is disposed within a first channel provided in the handle (110);
5. The device (100) as claimed in claim 4, wherein a proximal end of the first portion (132a) of each arm (132) extends out of the catheter shaft (120) and resides within a corresponding second channel of a plurality of second channels provided in the handle (110).
6. The device (100) as claimed in claim 4, wherein a locking assembly is provided with the handle (110) and is configured to lock the pusher rod (150).
7. The device (100) as claimed in claim 6, wherein the locking assembly comprises:
a. a first disc (115) comprising a plurality of first slots (115a);
b. a second disc (116) comprising a plurality of second slots (116a);
c. a plurality of plates (113) positioned between the first disc (115) and the second disc (116) and defining a central aperture configured to receive the pusher rod (150), each of the plurality of plates (113) comprising a pin (113a) disposed within a corresponding first slot (115a) of the plurality of first slots (115a) and a corresponding second slot (116a) of the plurality of second slots (116a), each pin (113a) moves within the respective first slot (115a) and the second slot (116a) in response to the rotation of the first disc (115);
d. a sleeve (112) having a slot (112a), wherein the first disc (115), the second disc (116) and the plurality of plates (113) are disposed within the sleeve (112); and
e. a tab (114) provided on a periphery of the first disc (115), wherein a portion of the tab (114) is disposed within the slot (112a) of the sleeve (112);
f. wherein in response to the rotation of the first disc (115) in a first pre-defined direction, each pin (113a) moves radially inward within the respective first slot (115a) and the respective second slot (116a), causing the plurality of plates (113) to move radially inwards and grip the pusher rod (150), thereby locking the pusher rod (150).
8. The device (100) as claimed in claim 4, wherein the device (100) comprises a switching element (117) provided in the handle (110) and electrically coupled to the electrodes (134) and the excitation source, the switching element (117) is configured to electrically connect and disconnect the excitation source from the plurality of electrodes (134).
9. The device (100) as claimed in claim 1, wherein a grip (152) is coupled to the proximal end of the pusher rod (150).
10. The device (100) as claimed in claim 1, wherein the excitation signal comprises a series of radiofrequency (RF) pulses.