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:
ENDOLUMINAL DEVICE

2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, 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 a medical device. More particularly, the present disclosure relates to an endoluminal device.
BACKGROUND OF INVENTION
[2] Endoscopic retrograde cholangiopancreatography (ERCP) is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain problems of biliary or pancreatic ductal systems. It is primarily performed by highly skilled and specialty trained gastroenterologists. The ERCP technique is used primarily to diagnose and treat conditions of the bile ducts and the main pancreatic duct, including gallstones, inflammatory strictures (scars), leaks (from trauma and surgery), and cancer.
[3] During an ERCP procedure/technique, a surgeon passes an endoscope through a patient’s mouth, esophagus and stomach into the duodenum. Once the surgeon is able to identify the targeted area for sampling, the surgeon inserts a narrow tube-like device to take a sample of the tissue. Conventionally available devices for sampling include a needle, etc. for taking the sample.
[4] The conventionally available devices have several disadvantages such as the needle may puncture the internal tissues and may lead to another serious injury. Or, owing to the complex structure of the device, it is very difficult to handle the device. Further, generally such devices are one-time use devices.
[5] Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] 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.
[7] The present disclosure relates to an endoluminal device. The endoluminal device includes a motor, a lead fastener, an inner tubular member, a wing nut, at least one longitudinal slot, a collection assembly. The lead fastener includes a cap region at its proximal end, a leg region at its distal end and a threaded region extending there between. The cap region is coupled to the motor and the leg region is coupled to a shear pin. The inner tubular member operatively coupled to the threaded region, includes at least one notch at its proximal end and a tab on its inner surface at the proximal end. The wing nut includes a central hub with a plurality of second threads on its inner surface and at least one wing coupled to the central hub, the wing seated in the respective notch. The at least one longitudinal slot that extends over at least the threaded region of the lead fastener and is operatively coupled to the wing. The collection assembly including a replaceable element is coupled to the distal end of the inner tubular member. The collection assembly when in a deployed configuration, due to rotation of the motor in a first direction, the collection assembly moves linearly forward and rotates to collect a sample from a desired collection area; Further, when the collection assembly is in the deployed configuration, the proximal end of the inner tubular member along with the wing nut is aligned with the distal end of the lead fastener and the tab locks with the shear pin.
[8] In another embodiment of the present disclosure, a method for collecting a sample from a collection area using the endoluminal device is disclosed. The method includes the following steps of rotating a motor in a first direction upon receipt of a first signal; pushing forward a collection assembly due to a torque generated by the motor upon rotation; rotating the collection assembly to collect the sample; and rotating the motor in a second direction upon receipt of a second signal to withdraw the collection assembly with the sample.
[9] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[10] 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.
[11] FIG. 1 depicts an assembled view of an endoluminal device 100 according to an embodiment of the present disclosure.
[12] FIG. 2 depicts an exploded view of the endoluminal device 100 according to an embodiment of the present disclosure.
[13] FIGs. 2a1 and 2a2 depict an upper portion and a lower portion of a handle of the endoluminal device 100 according to an embodiment of the present disclosure.
[14] FIGs. 2b to 2h depict different components of the endoluminal device 100 according to an embodiment of the present disclosure.
[15] FIG. 3 depicts a sequential arrangement of the components of the endoluminal device 100 according to an embodiment of the present disclosure.
[16] FIGs. 3a to 3d depict the components such as, a first shaft 141, a second shaft 143, a jaw-coupling of first shaft and second shaft 143 and a sleeve 145 according to an embodiment of the present disclosure.
[17] FIGs. 4a-4b depict arrangement of the components in an undeployed configuration of the endoluminal device 100 according to an embodiment of the present disclosure.
[18] FIGs. 4c and 4e depict arrangement of the components in a deployed configuration of the endoluminal device 100 according to an embodiment of the present disclosure.
[19] FIG. 4d depicts locking of a tab with a shear pin according to an embodiment of the present disclosure.
[20] FIG. 5 depicts a flowchart of a method of operation of the endoluminal device 100 according to an embodiment of the present disclosure.
[21] FIG. 6 depicts a flowchart of a method to replace the used replaceable element according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[22] Prior to describing the disclosure 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.
[23] 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.
[24] 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.
[25] 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.
[26] The present disclosure relates to an endoluminal device (or device). The device is used to procure a tissue sample from a body lumen such as, but not limited to, a pancreatic tube, a bile duct, an ampullary cancer, and a gallbladder. Although the present disclosure is described with examples of a gastro-intestinal (GI) tract device, the teachings of the present disclosure are equally applicable to an endoluminal device for procuring a tissue/blood sample from other ducts, pipes, vessels, etc. in a body and the same is within the scope of the teachings of the present disclosure.
[27] The endoluminal device of the present disclosure includes various components that are temporary and/or permanently coupled to each other to form an integrated device. The components include without limitation a handle, a motor, a catheter housing, and a collection assembly including a replaceable element. In a deployed configuration, due to rotation of the motor 115 in a first direction, the collection assembly moves linearly forward and rotates to collect a sample from a desired collection area. Further, due to rotation of the motor 115 in a second direction, the collection assembly is configured to retract with the sample collected from the desired collection area. Further, the collection assembly includes at least one component that can be replaced thus rendering the sampling device reusable.
[28] Now referring to the figures, FIG. 1 illustrates an assembled view of an exemplary embodiment of an endoluminal device (or device) 100. In an exemplary embodiment, as shown in FIG. 1, the device 100 includes without limitation a handle 102, at least one actuator 105, a catheter housing 107, a catheter 109, a wire 111, and a replaceable element 113. Details of the components are disclosed in description below.
[29] The handle 102 houses a plurality of components that are temporarily and/or permanently coupled to each other to form an integrated structure. In an embodiment, the handle 102 of the endoluminal device 100 is ergonomically shaped to enable a user to grip the device 100 comfortably for a long period of time. The handle 102 of the device 100 may be made of a material including but not limited to fiber composite, plastic, Teflon, etc. In an embodiment, the handle 102 is made of Acrylonitrile butadiene styrene (ABS). The handle 102 includes an upper portion 101, a lower portion 103, a proximal end 102a and a distal end 102b. Further details of the handle 102 are disclosed in FIGs. 2a1 and 2a2.
[30] The actuators 105 are housed in respective orifices 127 provided in the handle 102. The actuators 105 may be in the form of switches to turn on or off a motor 115. In an embodiment, the switches are mounted on a printed circuit board (pcb) placed inside the handle 102. The switches may be connected to a controller with the help of wires. It is to be noted that other functionally equivalent ways of mounting the actuators or switches are within the scope of the teachings of the present disclosure.
[31] In an embodiment of the present disclosure, two actuators, a first actuator 105a and second actuator 105b, are used. The first actuator 105a is configured to turn on the motor 115 and initiate a rotational motion of the motor 115 in a first direction while the second actuator 105b is configured to turn off the motor/reverse the rotation of the motor 115 to a second direction. In an embodiment, the first direction is clockwise direction while the second direction is anti-clockwise direction. Though the description has been provided considering the above, the teachings of the present invention are applicable to first direction being the anti-clockwise direction while the second direction being the clockwise direction.
[32] As discussed above, in an embodiment, the actuators 105 are connected to a controller (not shown). The controller is programmed to control the motor 115 including starting, stopping, or rotating the motor 115 in one of a clockwise and anti-clockwise direction. In an exemplary embodiment, the motor 115 is configured to rotate in a first or a second direction via a controller. During a procedure using the endoluminal device 100, when the first actuator 105a is pressed by the user, a first signal is sent to the controller. The controller is configured to start the clockwise rotation of the motor 115 upon receiving the first signal. Further, once the procedure (that is, collection of a sample) is completed, and the second actuator 105b is pressed by the user, a second signal is sent to the controller. The controller is configured such that upon receiving the second signal, the controller stops the motor 115 and after a predefined time, for example, two to three seconds, starts anti-clockwise rotation of the motor 115. The controller may be deployed inside the handle 102 or may be outside of the device 100 as per the requirement.
[33] Further, a power source (not shown) may be provided to supply electrical power to the motor 115. The power source may include without limitation, an adapter directly connected to a single-phase power source, a battery system, etc. In an embodiment, the power source is (12V DC Charger). The power source may be inside or outside of the device 100.
[34] The catheter housing 107 serves as a conduit between the catheter 109 and the handle 102. The catheter housing 107 (shown in FIG. 2b) has a proximal end 107a and a distal end 107b. The proximal end 107a of the catheter housing 107 is coupled to the distal end 102b of the handle 102. The catheter housing 107 may include a hollow body that tapers from the proximal end 107a to the distal end 107b. The proximal end 107a of the catheter housing 107 may be secured to the distal end 102b of the handle 102 by means of the without limitation, welding, adhesion, snap fix mechanism, screw fix mechanism, etc. In an embodiment of the present disclosure, the proximal end 107a of the catheter housing 107 is coupled to the distal end 102b of the handle 102 by a cap mechanism. The distal end 107b of the catheter housing 107 is coupled to the proximal end 109a of the catheter 109 as depicted. The coupling may be achieved via adhesive. Other functionally coupling mechanisms are within the scope of the teaching of the present disclosure. Due to temporary coupling of the proximal end 107a of the catheter housing 107 and the distal end 102b of the handle 102, the catheter housing 107 facilitates easy replacement of the replaceable element 113 once the procedure is done.
[35] The catheter housing 107 may be made of a material including, but not limited to ABS, PTFE, PETG etc. In an embodiment, the catheter housing 107 is made of Acrylonitrile butadiene styrene (ABS). The length of the catheter housing 107 may range from about 20 to about 40 mm. The diameter of the catheter housing 107 may range from 5 mm to 18 mm. In an embodiment the length and diameter of the catheter housing 107 are 35 mm and proximal end outer diameter (18 mm) - distal end outer diameter (5 mm), respectively.
[36] The catheter 109 may be in the form of a tube having a length extending from a proximal end 109a to a distal end 109b (shown in FIG. 2). Further, the tube may be hollow defining a lumen. The catheter 109 facilitates the movement of the replaceable element 113 longitudinally/ rotationally while the replaceable element 113 is moved to collect a sample from the desired collection area. The length of the catheter 109 may range from about 110 to about 230 mm. The diameter of the catheter 109 may range from about 1.32 to about 2.64 mm. In an embodiment, the length and diameter of the catheter 109 are 180 mm and 2.64 mm respectively.
[37] The wire 111 includes a proximal end 111a and distal end 111b (Fig. 2c). The wire 111 passes through the lumen of the catheter 109 and has the replaceable element 113 coupled at its distal end 111b. The proximal end 111a of the wire 111 is coupled to the distal end 143b of a second shaft 143. In an exemplary embodiment, a wire 111 is coupled to the distal end 143b of the second shaft 143 having the replaceable element 113 at its distal end 143b. The wire 111 may be made of a material including, but not limited to stainless-steel alloys etc.
[38] The length of the wire 111 may range from about 150 mm to about 260 mm. Further, the diameter of the wire 111 may range from about 0.3 mm to about 0.9 mm. In an embodiment of the present disclosure, the length and diameter of the wire 111 are 180 mm and 0.6 mm respectively.
[39] The replaceable element 113 is used to collect a tissue sample. In an embodiment, the replaceable element 113 includes a brush. The brush 113 is a longitudinal structure having a proximal end and a distal end on which a plurality of bristles 113a is mounted. The longitudinal structure may have a pre-defined shape including, but not limited to UV, round, spiral, etc. In an embodiment, the longitudinal structure is a circular rod. Further, the bristles 113a (shown in FIG. 2c) are provided on a substantial length of the longitudinal structure. The bristles 113a may be made of a material including, but not limited to plastic composites, fiber composites, nylon, metal, etc. In an embodiment, the bristles 113a are made of nylon. The bristles 113a facilitate efficient collection of the tissue sample. The longitudinal structure may be made of a material including but not limited to nylon, metal, plastic etc. In an embodiment, the longitudinal structure is made of nylon.
[40] The length of the brush 113 may range from about 15 mm to about 40 mm. The diameter of the brush 113 may range from about 1 mm to about 3 mm. In an embodiment, the length and diameter of the brush 113 are 30 mm and 2 mm respectively. It is to be noted that any other equivalent means can be as a replaceable element 113 to collect the sample.
[41] FIG. 2 depicts an exploded view of the handle 102 of the endoluminal device 100. As shown in the FIG. 2, the handle 102 includes an upper portion 101, a lower portion 103, a proximal end 102a and a distal end 102b. Further, the upper portion 101 and the lower portion 103 of the handle 102 define a lumen in which a plurality of components including without limitation a motor 115, a lead fastener 117, an outer tubular member 119, a wing nut 121, an inner tubular member 123, and a resilient member 125 are housed.
[42] The upper portion 101 and the lower portion 103 of the handle 102 are coupled by a lock mechanism. For example, the upper portion 101 (FIG. 2a1) and the lower portion 103 (FIG. 2a2) of the handle 102 may be locked by means of without limitation adhesive, snap fix mechanisms, etc. In an embodiment of the present disclosure, the upper portion 101 of the handle 102 includes a plurality of male units 139a and the lower portion 103 of the handle 102 includes a plurality of female units 139b. The upper portion 101 and the lower portion 103 may be locked by mating of the male unit 139a with the respective female unit 139b. Other functionally equivalent working mechanisms are within the scope of the teaching of the present disclosure.
[43] The upper portion 101 of the handle 102 may include a plurality of orifices 127 to seat respective actuators 105. Further, both the upper portion 101 and lower portions 103 of the handle 102 include a plurality of support members (for example, a first support member 129, a second support member 131, a third support member 133, a fourth support member 135, a fifth support member 137) for seating respective components (illustrated in FIGs. 2a1 and 2a2).
[44] In an exemplary embodiment, between the first support members 129, the motor 115 is supported. Further, between the second support members 131, the third support members 133, the fourth support members 135 and the fifth support members 137, the proximal end 119a of the outer tubular member 119, the distal end 119b of the outer tubular member 119, the inner tubular member 123 and the resilient member 125 are supported respectively.
[45] The motor 115 is placed at the proximal end 102a of the handle 102. The main function of the motor 115 is to provide a rotational motion to the lead fastener 117. The motion may be either clockwise or anti-clockwise in direction. The motor 115 can be without limitation a DC motor, a gear motor, a brushless DC motor (BLCD), etc. In an embodiment of the present disclosure, a DC gear motor is used. The motor 115 may have a proximal end 115a and a distal end 115b (shown in FIG. 2d).
[46] As shown in FIG. 2d, at the distal end 115b of the motor 115, a shaft project out. This shaft is coupled with the proximal end 117a of the lead fastener 117 temporarily or permanently. In an embodiment of the present disclosure, the shaft of the motor 115 is fixedly coupled to the proximal end 117a of the lead fastener 117 by snap fit & adhesive mechanism. Alternately, the lead fastener 117 may be coupled by means of, without limitation, adhesive, cap-fit mechanism etc.
[47] The lead fastener 117 includes a proximal end 117a and a distal end 117b. The total length of the lead fastener 117 may be divided in three regions (shown in FIG. 2e), namely, a cap region 117c, a threaded region 117d and a leg region 117e. In an exemplary embodiment, a lead fastener 117 includes a cap region 117c at its proximal end 117a, a leg region 117e at its distal end 117b and a threaded region 117d extending there between. In an embodiment, the cap region 117c includes a cavity to which the shaft of the motor 115 is coupled. It is to be noted that alternate ways of coupling the shaft of the motor 115 to the cap region 117c are within the teachings of the present disclosure. In an exemplary embodiment, the cap region 117c is coupled to the motor 115.
[48] The leg region 117e of the lead fastener 117 is provided towards the distal end 117b of the lead fastener 117. The threaded region 117d extends from the cap region 117c to the leg region 117e (shown in FIG. 2e). The threaded region 117d may include a plurality of first threads 117d1.
[49] The length of the cap region 117c may range, for example, from about 5 mm to about 8 mm. Further, the diameter of the cap region 117c may range, for example, from about 3 mm to about 6 mm. The length of the threaded region 117d may range, for example, from about 15 mm to about 26 mm. In an embodiment of the present disclosure, the length of the threaded region 117d is 26 mm. Further, the diameter of the threaded region 117d may range, for example, from about 3 mm to about 6 mm. The length of the leg region 117e may range, for example, from about 5 mm to about 10 mm. Further, the diameter of the leg region 117e may range, for example, from about 2 to about 4 mm. The lead fastener 117 may be made of a material including but not limited to polymer, plastic, teflon, metal, etc. In an embodiment the lead fastener 117 is made of Acrylonitrile butadiene styrene (ABS).
[50] Further, the leg region 117e of the lead fastener 117 includes a hole 117e1 meant for receiving a shear pin 117e2 (shown in FIG. 2e) during operation. In an exemplary embodiment, the leg region 117e is coupled to a shear pin 117e2. While as per the diagram, the hole 117e1 is depicted to be at the center of the leg region 117e, the placement of the hole 117e1 could be towards the distal end of the leg region 117e as well. The hole 117e1 is drilled/provided at least partially through the diameter of the lead fastener 117. In an exemplary embodiment, the leg region 117e is coupled to the shear pin 117e2 via a hole 117e1 drilled in the leg region 117e. The shear pin 117e2 is inserted in the hole 117e1 such that one end of the shear pin 117e2 is seated in the lumen of the hole 117e1, that is, the end of the pin 117e2 does not project out from the hole 117e1. The function of the shear pin 117e2 is to facilitate rotational motion of the inner tubular member 123 (explained below).
[51] The shear pin 117e2 may be made of a material including, but not limited to, stainless-steel alloys, plastic, etc. In an embodiment, the shear pin 117e2 is made of stainless-steel alloys. The shear pin 117e2 may have a pre-defined shape including but limited to round, cylindrical, etc. In an embodiment of the present disclosure, the shear pin 117e2 is of cylindrical shape. Further, the length of the shear pin 117e2 may range from about 3 mm to about 7 mm. The diameter of the shear pin 117e2 may range from about 0.5 to about 1 mm. In an embodiment, the length and diameter of the shear pin 117e2 are 5.8 mm and 1 mm, respectively.
[52] In an embodiment, the outer tubular member 119 (shown in FIG. 2f) includes a hollow cylindrical body having an outer surface, an inner surface, a proximal end 119a and a distal end 119b. Further, on the outer surface and towards the proximal end 119a of the outer tubular member 119, a plurality of nodes 119a1 are provided, for example two as depicted. The nodes 119a1 of the outer tubular member 119 facilitate proper engagement of the outer tubular member 119 in the housing (for example, in the second support member 131 of the housing).
[53] In an embodiment, the outer tubular member 119 is mounted between the second support member 131 and third support member133 of the handle 102 including the upper portion 101 and lower portion 103.
[54] Further, the body of the outer tubular member 119 may include at least one longitudinal slot 119c that extends at least partially along the length of the outer tubular member 119. In the depicted embodiment, the outer tubular member 119 with two longitudinal slots 119c is illustrated. As depicted, the longitudinal slots 119c are provided diametrically on the opposite sides of the body of the outer tubular member 119. However, the longitudinal slots 119c may be provided along the length of the body at predefined angles, for example 0-degree angle. Alternately, the longitudinal slots 119c may be provided along the length of the body at predefined angles, for example the longitudinal slots 119c may be provided along the length of the body at predefined angles, for example 90-degree angle. The longitudinal slots 119c define longitudinal spaces for accommodating wings 121b of the wing nut 121. Due to the longitudinal slots 119c, the wings 121b of the wing nut 121 are constrained to move in the linear direction and are not capable of rotation. In an embodiment, wings 121b may be placed at a 0-degree angle with respect to each other. In an embodiment, wings 121b may be placed at a 90-degree angle with respect to each other. In an exemplary embodiment, at least one longitudinal slot 119c that extends over at least the threaded region 117d of the lead fastener 117 and is operatively coupled to the wing 121.
[55] The length and diameter of the outer tubular member 119 may range from about 10 to about 40 mm respectively. In an embodiment of the present disclosure, the length and diameter of the outer tubular member 119 are 30 mm and 11 mm respectively. Further, the length of longitudinal slots 119c may range from about _8 mm_ to about _28 mm_. In an embodiment of the present disclosure, the length of the longitudinal slots 119c is _26 mm_. Further, in an embodiment, both the longitudinal slots 119c are of same length. The outer tubular member 119 may be made of a material including but not limited to polymer, plastic, teflon, metal etc. In an embodiment, the outer tubular member 119 is made of Acrylonitrile butadiene styrene (ABS).
[56] In an alternate embodiment (not shown), rather than a separate outer tubular member 119, the longitudinal slots 119c may be provided as an integrated part of the upper portion 101 and lower portion 103 of the handle 102. Alternately, the outer tubular member 119may include an upper portion integrated with the upper portion 101 and a lower portion 103 integrated with the lower portion 103 of the handle 102 which form longitudinal slots when the two portions, upper portion 101 and lower portion 103 are assembled. It is to be noted that various structures that achieve the function of the longitudinal slots 119c are within the teachings of the present disclosure.
[57] The wing nut 121 (shown in FIG. 2g) includes a central hub 121c with at least one wing 121b. In the depicted embodiment, the wing nut 121 includes a central hub 121c with a pair of wings 121b such that each wing 121b is disposed on either side of the central hub 121c. It is to be noted that the number of wings 121b correspond to the number of longitudinal slots 119c of the outer tubular member 119. Further, the placement of the wings 121b on either side of the central hub 121c is largely dictated by the position of the longitudinal slots 119c provided on the outer tubular member 119. For example, rather than being diametrically opposite, the wings 121b may be attached to the central hub 121c at predefined angles. In this case, the longitudinal slots 119c of the outer tubular member 119 will also be provided at the same angles with respect to each other in the body of the outer tubular member 119. The pre-defined angle may be 0 degree.
[58] The central hub 121c of the wing nut 121 is mounted on the threaded region 117d of the lead fastener 117 towards the proximal end of the threaded region 117d of the lead fastener 117 while the wings 121b are placed in respective longitudinal slots 119c of the outer tubular member 119. Further, the central hub 121c may include a plurality of second threads 121a on its internal surface. In an exemplary embodiment, a wing nut 121 includes a central hub 121c with a plurality of second threads 121a on its inner surface and at least one wing 121b coupled to a central hub 121c, the wing 121b seated in the respective notch 121a1. The second threads 121a of the central hub 121c mate with the corresponding first threads 117d1 of the threaded region 117d of the lead fastener 117. When the lead fastener 117 rotates, the wing nut 121 experiences a torque to rotate as well due to the threaded coupling. However, given the wings 121b are placed in the stationary longitudinal slots 119c, the wing nut 121 moves forward in a linear direction.
[59] The central hub 121c and the wings 121b may form an integral assembly or may be coupled by means of for example adhesive, snap fix mechanism, etc. The wing nut 121 (shown in FIG. 2e) may be made of a material including but not limited to Acrylonitrile butadiene styrene (ABS), plastic etc. In an embodiment, the wing nut 121 is made of Acrylonitrile butadiene styrene (ABS). The wings 121bmay have a pre-defined shape and dimension. The shape of the wings 121bmay be, is not limited to, square, rectangle, cylindrical, etc. In an embodiment, the shape of the wing 121bis rectangular.
[60] In an embodiment, the inner tubular member 123 includes a hollow cylindrical body having a proximal end 123a and a distal end 123b (shown in FIG. 2h). At the proximal end 123a, at least one notch 123a1 (for example, two oppositely placed notches 123a1 in the depicted embodiment) is provided. In an exemplary embodiment, an inner tubular member 123 includes at least one notch 123a1 at its proximal end 123a. It is to be noted that the number of notches 123a1 correspond to the number of wings of the wing nut 121. Further, the placement of the angular placement of the notches 123a1 is largely dictated by the position of the wings 121b provided with the wing nut 121. For example, rather than being diametrically opposite, the notches 123a1 may be placed at predefined angles, say 0 degree. Alternatively, the notches 123a1 may be placed at 90 degree angle with respect to each other. In an exemplary embodiment, the notches 123a1 may be placed at an angle ranging from 0 degree to 90 degree with respect to each other.
[61] The notch(es) 123a1 may be in the shape of rectangular cut-outs and provided at the periphery of the inner tubular member 123. Each notch 123a1 engages with the respective wing 121b of the wing nut 121. The dimension and shape of the notches 123a1 may correspond to the dimension and shape of the wings 121b The depth of the notches 123a1 may range from about 2 mm to about 3 mm. In an embodiment, the depth of the notches 123a1 is 2 mm. The depth of a notch 123a1 may correspond to the thickness of the wing 121b.
[62] The inner tubular member 123 is operatively coupled to the threaded region 117d of the lead fastener 117. In an exemplary embodiment, the inner tubular member 123 is mounted on the threaded region 117d of the lead fastener 117. In an undeployed configuration (shown in FIG. 4a), the proximal end 123a of the inner tubular member 123 is aligned with the proximal end of the threaded region 117d of the lead fastener 117. In the deployed configuration (shown in FIG. 4b), the proximal end 123a of the inner tubular member 123 is aligned with the distal end of the lead fastener 117.
[63] Further, on the inner surface of the inner tubular member 123 towards the proximal end 123a, a tab 123a2is provided. The tab 123a2 may be in the form of a projection, a block, circle, square, etc. In the deployed configuration, the tab 123a2 acts as a locking mechanism wherein the tab 123a2 locks with the shear pin 117e3 and thus forces the inner tubular member 123 to rotate during operation. In an exemplary embodiment, rotating includes rotating the collection assembly due to temporary locking of a shear pin 117e2 of the lead fastener 117 with a tab 123a2 of the inner tubular member 123.
[64] Further, the distal end 123b of the inner tubular member 123 may include a protrusion 123b1 (shown in FIG. 2h). In an embodiment, the protrusion 123b1 is provided at the center of the distal end 123b of the inner tubular member 123 and is cylindrically shaped. Alternately, the protrusion 123b1 may be displaced from the center of the distal end 123b of the inner tubular member 123. Further, the protrusion 123b1 may taper from the point of attachment at the distal end to its free end. The tapering diameter of the protrusion 123b1 may range from about 2.3 mm to about 4 mm. In an embodiment, the hollow cylindrical body and protrusion 123b1 of the inner tubular member 123 are an integral assembly.
[65] The inner tubular member 123 may be made of a material including, but not limited to, plastic, metal, ABS etc. In an embodiment. the inner tubular member 123 is made of Acrylonitrile butadiene styrene (ABS). Further, the length of the inner tubular member 123 may range from about 10 m to about 45 mm. The diameter of the inner tubular member 123 may range from about 4 mm to about 10 mm. In an embodiment, the length and the diameter of the inner tubular member 123 are 42 mm and 8.5 mm, respectively.
[66] The resilient member 125 is disposed between the catheter housing 107 and distal end of the protrusion 123b1 of the inner tubular member 123. In an exemplary embodiment, a resilient member 125 is operatively coupled to the distal end 123b of the inner tubular member 123.The resilient member 125 is at least partially compressed by the protrusion 123b1 of the inner tubular member 123 during the fully deployed configuration of device 100. Thus, the resilient member 125 dictates the amount of longitudinal movement the inner tubular member 123 can make and thereby the brush 113 during the procedure. Further, the resilient member 125 also provides a push force (backward force) to the inner tubular member 123 so that the inner tubular member 123 can revert to its first stage (the undeployed configuration). The resilient member 125 may be a spring. The length of the resilient member 125 may range, for example, from 10 mm to 40 mm. In an embodiment, the length of the resilient member 125 is 30 mm.
[67] FIG. 3 depicts an arrangement of all the components provided inside the handle 102 and the catheter 109 of the endoluminal device 100. For sake of brevity, structural details of the components 115-125 are not repeated and can be referred from FIG. 2 and associated FIGS. 2a – 2h above and explanation of additional components disclosed in FIG. 3 is provided below. The additional components include without limitation, a first shaft 141, a second shaft 143, and a sleeve 145.
[68] The first shaft 141 (shown in FIG. 3a) is a hollow tubular structure having a proximal end 141a, a distal end 141b and a lumen extending there between. The proximal end 141a of the first shaft 141 is coupled to the tapered free end of the protrusion 123b1 of the inner tubular member 123. The coupling may be temporary or permanent. The lumen of the first shaft 141 facilitates passage of the wire 111. The first shaft 141 receives a push force from the inner tubular member 123 when the procedure is underway. The distal end 141b of the first shaft 141 may include a first jaw 141b1.
[69] The first shaft 141 may be made of a material including, but not limited to, stainless-steel alloys, polymer etc. In an embodiment, the first shaft 141 is made of Acrylonitrile butadiene styrene (ABS). The length of the first shaft 141 may range, for example, from about 5 mm to about 15 mm. Further, the diameter of the first shaft 141 may range, for example about 0.4 to about 0.9 mm. In an embodiment, the length and the diameter of the first shaft 141 are 10 mm and 0.6 mm, respectively.
[70] The second shaft 143 (shown in FIG. 3b) is also a hollow tubular structure having a proximal end 143a and a distal end 143b. The proximal end 143a of the second shaft 143 includes a second jaw 143a1. The second jaw 143a1 at the proximal end 143a of the second shaft 143 is removably coupled to the first jaw 141b1 of the first shaft 141. Thus, the first shaft 141 and second shaft 143 are coupled through a jaw-coupling mechanism (shown in FIG. 3c) The distal end of the second shaft 143 is coupled to the wire 111 to which the brush 113 is coupled.
[71] The second shaft 143 may be made of a material including but not limited to nylon, stainless-steel alloys, etc. In an embodiment, the second shaft 143 is made of stainless-steel. The length of the second shaft 143 may range, for example about 5 mm to about 15 mm. Further, the diameter of the second shaft 143 may range, for example about 0.4 to about 0.9 mm. In an embodiment, the length and the diameter of the second shaft 143 are 10 mm and 0.6 mm, respectively.
[72] Further, towards the distal end 141b of the first shaft 141, a first ring 147 may be provided. Similarly, towards the distal end 143b of the second shaft 143, a second ring 149 may be provided. In an exemplary embodiment, the first shaft 141 may include at least one first ring 147 towards its distal end 141b. In an exemplary embodiment, the second shaft 143 may include at least one second ring 149 towards its distal end 143b. In an embodiment, the first ring 147 and the second ring 149 are fixedly attached at the distal ends of the respective shafts. The first ring 147 and the second ring 149 may be secured by means of, without limitation adhesive etc. In an embodiment, the first ring 147 and second ring 149 are attached by adhesive mechanism. Between the two rings 147 and 149, a sleeve 145 is mounted on the coupled first and second shafts 141 and 143. In an exemplary embodiment, on top of the first shaft 141 and the second shaft 143, the sleeve 145 is mounted. The rings 147 and 149 act as a stopper for the sleeve 145 beyond which, the sleeve 145 cannot move.
[73] As shown in FIG. 3d, the sleeve 145 is present over the first shaft 141 and second shaft 143. The sleeve 145 may be slidable between the first ring 147 and the second ring 149. The sleeve 145 secures the coupling of the first shaft 141 and the second shaft 143.
[74] The sleeve 145 includes a proximal end 145a and a distal end 145b. The proximal end 145a of the sleeve 145 may have a bifurcated structure 145a1. The bifurcated structure 145a1 may have a plurality of the curved straps 145a2. The curved straps 145a2 of the bifurcated structure 145a1 of the sleeve 145 help in the engagement to the first ring 147 and/or to the second ring 149 during the operation of the device 100. In an embodiment of the present disclosure, the distal end 145b of the sleeve 145 is tapered in shape.
[75] The sleeve 145 may be made of a material including but not limited to plastic, teflon, metal alloys, etc. In an embodiment, the sleeve 145 is made of Acrylonitrile butadiene styrene (ABS). The length of the sleeve 145 may range, for example, from about 4 m to about 6 mm. The diameter of the sleeve 145 may range, for example, from about 0.8 mm to about 1 mm. In an embodiment, the length and the diameter of the sleeve 145 are 5 mm and 0.8 mm, respectively. The sleeve 145 may be hollow from inside.
[76] In the context of the present disclosure, the catheter 109, the first shaft 141, the second shaft 143, the wire 111 and the replaceable element 113 are termed as a collection assembly. In an exemplary embodiment, a collection assembly coupled to the distal end 123b of the inner tubular member 123, the collection assembly including a replaceable element 113. In an exemplary embodiment, a collection assembly includes: a catheter 109 having a proximal end 109a and a distal end 109b; a first shaft 141 having a first jaw 141b1 at its distal end 141b, a second shaft 143 having a second jaw 143a1 at its proximal end 143a, the first jaw 141b1 removably coupled to the second jaw 143a1; and a wire 111 coupled to the distal end 143b of the second shaft 143 having the replaceable element 113 at its distal end 143b.
[77] FIG. 4a depicts the arrangement of the aforesaid components in the undeployed configuration while FIG. 4b depicts the arrangement of the aforesaid components in the deployed configuration. During the undeployed configuration, the components such as the wing nut 121 and the proximal end 123a of the inner tubular member 123 are aligned with the proximal end of the threaded region 117d of the lead fastener 117. Further, the brush 113 is contained within the catheter 109 (as shown in FIG. 4b).
[78] In the deployed configuration as illustrated in FIG. 4c, the proximal end 123a of the inner tubular member 123 along with the wing nut 121 is aligned with the distal end 117b of the lead fastener 117 and the tab 123a2 locks with the shear pin 117e2 (as shown in FIG. 4d). Due to the movement of the inner tubular member 123 towards the distal end of the device 100, the resilient member 125 is compressed and the brush 113 pushed linearly forward, hence exposed to the collection area (as shown in FIG. 4e). The motion of the components during the deployed configuration is explained in flow chart (in FIG. 5) given below.
[79] In accordance with the present disclosure, FIG. 5 depicts a flow chart of a method involved in collecting a tissue sample by operating the endoluminal device 100. The process commences at step 501. At this step, the device 100 is in the undeployed configuration. At this step, the user presses the first actuator 105a.
[80] At step 503, the first signal is sent to the controller to start the motor 115. The controller starts the motor 115. Upon receipt of the first signal by the controller, the motor 115 thus starts rotating in a first direction, say, a clockwise direction.
[81] At step 505, as the distal end 115b of the motor 115 (namely, the shaft) is coupled to the cap region 117c of the lead fastener 117, the lead fastener 117 also starts rotating in the clockwise direction due to the torque generated by the motor 115. The torque just generated by the motor 115 pushes forward the collection assembly.
[82] At step 507, due to the rotation of the lead fastener 117, the wing nut 121 receives a torque for rotation. However, since the wings 121b of the wing nut 121 are placed in the longitudinal slots 119c of the outer tubular member 119 and thus constrained to rotate, the wing nut 121 is triggered to move forward linearly along the longitudinal slots 119c. At the start of the rotation of the lead fastener,117 the wing nut 121 as well as the inner tubular member 123 are placed inside the outer tubular member 119.
[83] At step 509, due to the forward force exerted by the wing nut 121, the inner tubular member 123 is pushed forward towards the distal end of the handle 102. In an exemplary embodiment, pushing an inner tubular member 123 in a forward direction due to movement of the wing nut 121, pushes the collection assembly in the forward direction. As the inner tubular member 123 moves forward, it vacates the outer tubular member 119 and compresses the resilient member 125. The inner tubular member 123 moves forward till the tab 123a2 inside the inner tubular member 123 at its proximal end 123a, locks with the shear pin 117e2 temporarily, provided in the hole 117e1 of the leg region 117e of the lead fastener 117 (as shown in FIG. 4d). In this position, the wing nut 121 is completely outside the outer tubular member 119. Further, the catheter 109 coupled to the protrusion 123b1 moves forward and in turn, the wire 111 with the brush 113 is placed in the desired collection area. This is referred as the deployed configuration of the endoluminal device 100. In this deployed configuration, given the motor 115 is on and the lead fastener 117, the wing nut 121, the inner tubular member 123 and the catheter 109 are in rotational motion, the brush 113 rotates as well and due to the rotational action of the brush, a sample from the collection area is collected. This rotation enables the collection assembly to collect the sample.
[84] At step 511, the motor 115 is paused. This may be due to an action of a user, say the user may press the second actuator 105b. The user may press the second actuator 105b after a predefined time period, say five seconds due to which a second signal is sent to the controller to pause the motor 115. In an exemplary embodiment, receipt of the second signal includes one of receipt of the second signal by a controller or a user.
[85] At step 513, the controller is configured to restart the motor 115 after a pre-defined duration, for example, two to three seconds, in a second direction, say, an anti-clockwise direction. The motor 115 thus now starts rotating in the anti-clockwise direction. Alternately, rather than auto-configuration, a user may be required to press the second actuator 105b again to initiate anti-clockwise rotation of the motor 115. Alternatively, in an exemplary embodiment, rotating the motor 115 in a second direction upon receipt of a second signal allows for withdrawal of the collection assembly with the sample.
[86] At step 515, as the distal end 115b of the motor 115 is attached to the cap region 117c of the lead fastener 117, the lead fastener 117 also starts rotating in the anti-clockwise direction. This leads to anti-clockwise rotation of the wing nut 121. Further, the coupling of the tab 123a2 of the inner tubular member 123 and the shear pin 117e2 breaks, as in, the tab 123a2 of the inner tubular member 123 dissociates from the shear pin 117e2 of the lead fastener 117.
[87] At step 517, during the anticlockwise motion of the wings 121b of the wing nut 121, once the wings 121b are aligned with the longitudinal slots 119c of the outer tubular member 119, the wing nut 121 along with the inner tubular member 123 re-enter the outer tubular member 119. The anti-clockwise rotation of the motor 115 may continue till the undeployed configuration is reached.
[88] At step 519, once the device 100 reaches the undeployed configuration, the brush 113 may be removed from the second shaft 143 and stored in an air tight container for further analysis of the sample. By installing a new brush 113, the device 100 is ready for reuse. In an exemplary embodiment, replacing at least a replaceable component including the brush 113 of the collection assembly prepares an endoluminal device for reuse.
[89] FIG. 6 depicts a flow chart of a process involved in removing the used brush 113 and restoring the handle 102 of the device 100 for re-use. The process commences at step 601. At this step, once procedure is done, the catheter housing 107 may be removed from the distal end 102b of the handle 102. Due to the dismantling of the catheter housing 107, the catheter 109 coupled to the catheter housing 107, is also removed.
[90] At step 603, the brush 113 may be dismantled form the second shaft 143. Once the catheter housing 107 is removed, the coupling of the second shaft 143 and the wire 111 of the brush 113 is exposed. Further, the proximal end 111aof the wire 111 along with brush 113 is disconnected from the distal end 143b of the second shaft 143.
[91] At step 607, a new wire with a new replaceable element 113 is coupled to the distal end of the second shaft 143 via a means as disclosed above. The components may then be reassembled to yield the endoluminal device 100 for use.
[92] The endoluminal device 100 of the present disclosure alone is sufficient for positioning the brush at the desired collection area as well as collecting the tissue sample. Further, the endoluminal device 100 is reusable as once the procedure is performed, the endoluminal device 100 can be opened and the second tube with the brush can be replaced with a new tube.
[93] 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 endoluminal device (100) comprising:
a. a motor (115);
b. a lead fastener (117) including a cap region (117c) at its proximal end (117a), a leg region (117e) at its distal end (117b) and a threaded region (117d) extending there between, the cap region (117c) coupled to the motor (115) and the leg region (117e) coupled to a shear pin (117e2);
c. an inner tubular member (123) operatively coupled to the threaded region (117d), including at least one notch (123a1) at its proximal end (123a) and a tab (123a2) on its inner surface at the proximal end (123a);
d. a wing nut (121) including a central hub (121c) with a plurality of second threads (121a) on its inner surface and at least one wing (121b) coupled to the central hub (121c), the wing (121b) seated in the respective notch (121a1);
e. at least one longitudinal slot (119c) that extends over at least the threaded region (117d) of the lead fastener (117) and is operatively coupled to the wing (121); and
f. a collection assembly coupled to the distal end (123b) of the inner tubular member (123), the collection assembly including a replaceable element (113);
wherein in a deployed configuration, due to rotation of the motor (115) in a first direction, the collection assembly moves linearly forward and rotates to collect a sample from a desired collection area;
wherein, in the deployed configuration, the proximal end (123a) of the inner tubular member (123) along with the wing nut (121) is aligned with the distal end (117b) of the lead fastener (117 and the tab (123a2) locks with the shear pin (117e2.
2. The endoluminal device as claimed in claim 1 wherein the collection assembly includes:
a. a catheter 109 having a proximal end (109a) and a distal end (109b);
b. a first shaft (141) having a first jaw (141b1) at its distal end (141b),
c. a second shaft (143) having a second jaw (143a1) at its proximal end (143a), the first jaw (141b1) removably coupled to the second jaw (143a1); and
d. a wire (111) coupled to the distal end (143b) of the second shaft (143) having the replaceable element (113) at its distal end (143b).
3. The endoluminal device (100) as claimed in claim 1 wherein, due to rotation of the motor (115) in a second direction, the collection assembly is configured to retract with the sample collected from the desired collection area.
4. The endoluminal device (100) as claimed in claim 1 wherein the replaceable element (113) includes a brush.
5. The endoluminal device (100) as claimed in claim 1 wherein the device includes a resilient member (125) operatively coupled to the distal end (123b of the inner tubular member (123).
6. The endoluminal device (100) as claimed in claim 1 wherein the cap region (117c) of the lead fastener (117) includes a cavity.
7. The endoluminal device (100) as claimed in claim 1 wherein the leg region (117e) is coupled to the shear pin (117e2) via a hole (117e1) drilled in the leg region (117e.
8. The endoluminal device (100) as claimed in claim 1 wherein the motor (115 is configured to rotate in a first or a second direction via a controller.
9. The endoluminal device (100) as claimed in claim 1 wherein the wings (121b) are placed at an angle ranging from 0 degree to 90 degree with respect to each other.
10. The endoluminal device (100) as claimed in claim 1 wherein the longitudinal slots (119c) are placed at an angle ranging from 0 degree to 90 degree with respect to each other.
11. The endoluminal device (100) as claimed in claim 1 wherein the notches (123a1) are placed at an angle ranging from 0 degree to 90 degree with respect to each other.
12. The endoluminal device (100) as claimed in claim 1 wherein the first shaft (141) and a second shaft (143) include at least one first ring (147) and second ring (149) respectively.
13. The endoluminal device (100) as claimed in claim 1 wherein on top of the first shaft (141) and a second shaft (143), a sleeve (145) is mounted.
14. A method for collecting a sample from a collection area using an endoluminal device (100), the method comprising:
a. rotating a motor (115) in a first direction upon receipt of a first signal;
b. pushing forward a collection assembly due to a torque generated by the motor (115) upon rotation;
c. rotating the collection assembly to collect a sample; and
d. rotating the motor (115) in a second direction upon receipt of a second signal to withdraw the collection assembly with the sample.
15. The method as claimed in claim 14, wherein the method includes replacing at least a replaceable component of the collection assembly to prepare an endoluminal device for reuse.
16. The method as claimed in claim 14, wherein the pushing includes:
a. triggering forward linear motion of a wing nut (121) upon rotation of a lead fastener (117) due to a torque generated by the motor (115) upon rotation, the wing nut (121 including one or more wings (121b) situated in respective longitudinal slots (119c); and
b. pushing an inner tubular member (123) in a forward direction due to movement of the wing nut (121), thereby pushing the collection assembly in the forward direction.
17. The method as claimed in claim 14, wherein the rotating includes rotating the collection assembly due to temporary locking of a shear pin (117e2) of the lead fastener (117 with a tab (123a2 of the inner tubular member (123).
18. The method as claimed in claim 14, wherein the receipt of the second signal includes one of receipt of the second signal by a controller or a user.
19. The method as claimed in claim 14, wherein the rotating the motor (115) in the second direction includes detaching the shear pin (117e2) from the tab (123a2) of the inner tubular member (123).
20. The method as claimed in claim 14, wherein the rotating the motor (115) in the second direction includes rotating the lead fastener (117 in the second direction enabling the one or more wings (121b) of the wing nut (121) to recouple with the respective longitudinal slots (119c).