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:
SCLEROTHERAPY 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:

FILED OF THE INVENTION
[001] The present disclosure relates to medical device. More particularly, the present disclosure relates to a sclerotherapy device.
BACKGROUND OF THE INVENTION
[002] Varicose veins is a common condition mostly affecting adults. In this condition, the veins become twisted and enlarged, causing pain and discomfort in some patients. They usually appear in legs. Sclerotherapy is one of the most commonly applied method for treating varicose veins.
[003] Sclerotherapy is a minimally invasive technique where a chemical solution, for example, an adhesive, is injected directly into the damaged portion of the veins for closure. Delivering a precise quantity of the chemical solution is very crucial. Currently, medical practitioners, typically, load a syringe with the chemical solution and push its plunger manually to deliver the chemical solution at a target site. However, it is difficult for the medical practitioners to control the quantity precisely. Some devices are currently available that can control the quantity of the chemical solution. In such devices, a syringe is coupled to the device and the chemical solution is delivered by pushing a piston controlled by a trigger, e.g., a lever in a handle of the device, which is manually operated. Therefore, such devices too are prone to human errors. Further, the medical practitioner needs to continuously press the trigger to push the piston. This makes the devices cumbersome to use.
[004] Therefore, there is a need for a device that overcomes the challenges associated with the conventional devices.
SUMMARY OF THE INVENTION
[005] 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.
[006] The present disclosure relates to a medical device. In an embodiment, the medical device includes a motor, a gearhead and a plunger. The motor has a shaft and rotates at a pre-defined rotational speed. The gearhead is coupled to the shaft and is configured to rotate in response to the rotation of the motor. The gearhead includes at least one tooth provided on a periphery of the gearhead along a partial circumference of the gearhead. The plunger is operatively coupled to the gearhead and a syringe having a liquid. The plunger includes a plurality of teeth with at least one tooth of the plurality of teeth operatively engaging with the at least one tooth of the gearhead. The plunger is configured to move linearly in a distal direction in response to the rotation of the gearhead in a first direction and cause the syringe to the deliver the liquid into a patient’s body.
BRIEF DESCRIPTION OF DRAWINGS
[007] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of 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.
[008] Fig. 1a depicts a right-side perspective view of a device 100 according to an embodiment of the present disclosure.
[009] Fig. 1b depicts an isometric view of the device 100 according to an embodiment of the present disclosure.
[0010] Fig. 1c depicts a cross-sectional view of the device 100 according to an embodiment of the present disclosure.
[0011] Fig. 1d depicts an exploded view of the device 100 according to an embodiment of the present disclosure.
[0012] Fig. 1e depicts a left-side perspective view of the device 100 according to an embodiment of the present disclosure.
[0013] Fig. 2a depicts a cross-sectional view of a left section 101a of a handle 101 of the device 100 according to an embodiment of the present disclosure.
[0014] Fig. 2b depicts a cross-sectional view of a right section 101b of the handle 101 of the device 100 according to an embodiment of the present disclosure.
[0015] Fig. 3a depicts a side view of a plunger 102 of the device 100 according to an embodiment of the present disclosure.
[0016] Fig. 3b depicts a perspective view of the plunger 102 of the device 100 according to an embodiment of the present disclosure.
[0017] Fig. 4a depicts a perspective view of a motor 103 along with a shaft 104 of the device 100 according to an embodiment of the present disclosure.
[0018] Fig. 4b depicts a perspective view of a gearhead 105 of the device 100 according to an embodiment of the present disclosure.
[0019] Fig. 5a is a perspective view depicting the engagement of the gearhead 105 and the plunger 102 according to an embodiment of the present disclosure.
[0020] Fig. 5b is a top view depicting the engagement of the gearhead 105 and the plunger 102 according to an embodiment of the present disclosure.
[0021] Fig. 6 depicts a top perspective view of a clamp 106 in accordance with one or more embodiment of the present disclosure.
[0022] Fig. 7a depicts a perspective view of a top section 107a of a holder 107 of the device 100 according to an embodiment of the present disclosure.
[0023] Fig. 7b depicts a perspective view of a bottom section 107b of the holder 107 of the device 100 according to an embodiment of the present disclosure.
[0024] Fig. 8a depicts a side view of a locking hub 108 according to an embodiment of the present disclosure.
[0025] Fig. 8b depicts a front view of the locking hub 108 according to an embodiment of the present disclosure.
[0026] Fig. 9 depicts a syringe 109 according to an embodiment of the present disclosure.
[0027] Fig. 10 depicts an exemplary flowchart of a method 1000 for operating the device 100 according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF DRAWINGS
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] The present disclosure relates to a device capable of delivering a fluid into a patient’s body in a controlled manner. In an embodiment, the device includes a plunger having a plurality of teeth and a gearhead having at least one tooth engaging the plurality of teeth of the plunger. The gearhead is driven by a motor of the device. The plurality of teeth of the plunger translates the rotational motion of the gearhead into a longitudinal motion and moves the plunger in a forward direction. A syringe loaded with an adhesive is operatively coupled to the plunger. The forward (i.e., the distal) movement of the plunger, causes the syringe to deliver the fluid (e.g., the adhesive) at a target location into the patient’s body (e.g., into the affected vein). According to an embodiment, the gearhead includes one tooth. The motor rotates at a constant rotational speed. The rotational speed of the motor, a diameter of the gearhead and a pitch of the plurality of the teeth of the plunger are designed such that the plunger moves by a pre-defined distance for each rotation of the gearhead and the syringe delivers the fluid at a desirable delivery rate. Once the motor is switched ON, the device operates automatically to deliver the fluid in a controlled manner.
[0033] In an example scenario, the proposed device is used in a sclerotherapy procedure to deliver an adhesive at a desired delivery rate into an affected vein of the patient to treat varicose vein and/or spider vein. The device delivers precise quantity of the adhesive, thereby improving the accuracy and effectiveness of the sclerotherapy procedure. Further, the device is automatic and hence, reduces manual errors observed with conventional sclerotherapy devices and the associated consequence of delivering incorrect amount of the adhesive. Further, the user can operate the device via a simple press of a control element provided in the device, thereby improving the usability of the device over the conventional sclerotherapy devices requiring continuous manual operation of a trigger by the user.
[0034] Though the device has been explained below in the context of sclerotherapy to deliver an adhesive into the patient’s veins, the teachings of the present disclosure can also be applied to deliver any fluid into a patient’s body in a controlled manner during a medical procedure and the same is covered within the scope of the present disclosure.
[0035] Now referring to figures, Fig. 1a illustrates an assembly view of an exemplary embodiment of a sclerotherapy device 100 (hereinafter, device 100). Figs. 1b – 1d illustrate various views of the device 100, according to an embodiment. In an embodiment, the device 100 is used to deliver an adhesive to an affected vein during a sclerotherapy procedure. The adhesive may be Sodium tetradecyl sulfate (STS), Polidocanol (POL), Ethanolamine Oleate (EO), n-butyl-2-cyanoacrylate, etc. or any other suitable adhesive. The device 100 has a proximal end 100a and a distal end 100b. In an embodiment, the device 100 includes a handle 101, a plunger 102, a motor 103, a shaft 104, a gearhead 105, a clamp 106, a holder 107, a locking hub 108, a syringe 109, a control element 110, and a power source 111.
[0036] The handle 101 has a proximal end 101c and a distal end 101d. The handle 101 has an ergonomic shape, which enables a medical practitioner to comfortably grip and operate the device 100. In the depicted embodiment, the handle 101 is shaped in the form of a gun or T-shaped structure having a tubular body 101e and a stem portion 101f. The tubular body 101e is hollow and has a cylindrical shape. The stem portion 101f is hollow and has a generally rectangular shape. It should be appreciated that the tubular body 101e and the stem portion 101f may have any other suitable shape. The handle 101 encloses at least a portion of the plunger 102, the motor 103, the control element 110, the power source 111 as depicted in Fig. 1c. The handle 101 can be made of a material such as, without limitation Acrylonitrile Butadiene Styrene (ABS), nylon, High-density Polyethylene (HDPE), Low-density polyethylene (LDPE), Polycarbonate (PC), etc. In an embodiment, the handle 101 is made of ABS. The handle 101 may be suitably dimensioned based upon the requirements.
[0037] In an embodiment, the handle 101 includes a left section 101a and a right section 101b. The right section 101b and the left section 101a are coupled to form the handle101. The right section 101b and the left section 101a can be coupled using, for example screws, a snap-fit mechanism, a stud-groove coupling mechanism, etc. In the depicted embodiment, the right section 101b and the left section 101a are coupled using the stud-groove mechanism. Accordingly, in an embodiment, a plurality of studs 101b3 (shown in Fig. 2b) are provided on edges of the right section 101b and a plurality of grooves 101a3 (shown in Fig. 2a) are provided on edges of the left section 101a. The size and shape of the plurality of studs 101b3 and the grooves 101a3 are complementary to each other to provide a tight fit.
[0038] The tubular body 101e of the handle 101 includes a channel 112. The channel 112 extends from the proximal end 101c of the handle 101 to the distal end 101d of the handle 101 for at least partial length of the tubular body 101e. The channel 112 is configured to receive at least a portion of the plunger 102 as explained later. The channel 112 can be provided on any one of the left section 101a or the right section 101b of the handle 101. In the depicted embodiment, the left section 101a is provided with the channel 112 (as shown in Fig. 1e and Fig. 2a). The channel 112 includes a cut-out 112a in a lower arm of the channel 112 for a partial length of the channel 112. The cut-out 112a provides space for the plunger 102 to engage with the gearhead 105 (explained later).
[0039] The stem portion 101f of the handle 101 includes holes 101a5 in any one of the left section 101a or the right section 101b for coupling the clamp 106. In an embodiment, the clamp 106 is coupled to the holes 101a5 as explained later. In the depicted embodiment, the left section 101a includes the holes 101a5 (shown in Fig. 2a). The stem portion 101f further includes a plurality of protrusions 113 for housing the power source 111. In an embodiment, the plurality of protrusions 113 include four protrusions 113 arranged at corners of a rectangular area corresponding to the size of the power source 111 and the power source 111 is pressed between the plurality of protrusions 113 to snugly fit the power source 111 within the rectangular area. In the depicted embodiment, the right section 101b includes the plurality of protrusions 113 (shown in Fig. 2b).
[0040] Figs. 3a and 3b show various views of the plunger 102 according to an embodiment. The plunger 102 is operatively coupled to the gearhead 105 and the syringe 109 having a liquid (e.g., the adhesive). The plunger 102 has a proximal end 102a and a distal end 102b, defining a length therebetween. In an embodiment, the plunger 102 includes a head 102c at the distal end 102b and a body 102d extending from the head 102c to the proximal end 102a. The head 102c may have any suitable shape including, without limitation, circular, rectangular, square, etc. In an embodiment, the head 102c has a disc shape. The head 102c is operatively coupled to the syringe 109. The body 102d may have any suitable shape. In an embodiment, the body 102d has the shape of a rectangular plate with a curved edge at the proximal end 102a. The plunger 102 may optionally include a projection 102e on a top surface of the body 102d extending from the head 102c for at least a partial length of the plunger 102. The plunger 102 includes a plurality of teeth 102f provided on a medial side of the body 102d. The plurality of teeth 102f extends at least for a partial length of the plunger 102. Successive teeth 102f of the plurality of teeth 102f are separated by a pre-defined pitch P1. The pre-defined pitch P1 is chosen based, at least, upon a desired delivery rate of the adhesive, a rotational speed of the motor 103, dimensions of the gearhead 105, the number of the at least one tooth on the gearhead 105. During the operation of the device 100, a set of the plurality of teeth 102f operatively couples with the gearhead 105 and translate a rotational motion of the gearhead 105 into a longitudinal motion of the plunger 102 as explained later. At least a partial length of a lateral side of the body 102d remains in the channel 112 (as depicted in Figs 1a and 1c) during the operation of the device 100. This ensures that the plunger 102 moves longitudinally in a straight path without any deviations. Optionally, or in addition, the plunger 102 includes a tab 102g provided towards the proximal end 102a. The tab 102g allows a user to grip the plunger 102 easily and manually move the plunger 102 in the proximal direction as needed. In an embodiment, the body 102d partially extends out of the handle 101 at the proximal end 101c. Cut-outs 101a2 and 101b2 are provided in the left section 101a and the right section 101b, respectively, at the proximal end 101c (shown in Figs. 2a – 2b) such that when the left section 101a and the right section 101b are coupled, the cut-outs 101a2 and 101b2 form an opening of a shape corresponding to the cross-section of the plunger 102. This allows free movement of the plunger 102.
[0041] The plunger 102 can be made of a suitable material such as, without limitation, ABS, nylon, HDPE, LDPE, PC, etc. In an exemplary implementation, the plunger 102 is made of ABS. The head 102c and the body 102d may be suitably dimensioned. For example, the head 102c may have a diameter ranging between 10.40 mm and 12.40 mm. The length of the head 102c may be between 2.5 mm and 3 mm. In an exemplary implementation, the diameter and the length of the head 102c are 10.40 mm and 2.50 mm, respectively. The length of the body 102d may be between 200 mm and 240 mm. The width of the body 102 may be between 2.5 mm and 2.6 mm. In an exemplary implementation, the length and width of the body 102d are 226 mm and 2.6 mm, respectively. The plurality of teeth 102f can be provided for a length between 105 mm and 140 mm. In an exemplary implementation, the plurality of teeth 102f is provided for 139 mm.
[0042] In accordance with one or more embodiment of the present disclosure, the longitudinal motion of the plunger 102 is driven by the motor 103. An embodiment of the motor 103 is illustrated in Fig. 4a. The motor 103 can be an AC motor or a DC motor. In an embodiment, the motor 103 is a DC motor. In an exemplary implementation, the motor 103 is a brushed DC motor. The motor 103 is suitably dimensioned. In an embodiment, the motor 103 has a cross-section having a length and a width equal to 12 mm and 10 mm, respectively. The motor 103 may have a power rating ranging from 1 W to 12 W. In an embodiment, the motor 103 has a power rating of 6 W. The motor 103 rotates at a pre-defined rotational speed. The pre-defined rotational speed is designed based upon requirements. In an embodiment, a controller, e.g., a dimmer (not shown), is provided. The controller is electrically coupled with the motor 103. The controller is configured to control the rotational speed of the motor 103. The user can manipulate the controller to change the rotational speed of the motor 103 and thereby adjust the delivery rate of the fluid (in the depicted embodiment, the adhesive) either before or during the medical procedure as per requirements.
[0043] The shaft 104 is coupled to the motor 103. The shaft 104 rotates in response to the rotation of the motor 103. The shaft 104 has a first end 104a and a second end 104b. The shaft 104 includes a first portion 104c provided towards the first end 104a and a second portion 104d provided towards the second end 104b. The first portion 104c may have a cross-section of a suitable shape including, without limitation, circular, triangular, hexagonal, square, semi-circular, D shape, etc. In an embodiment, the first portion 104c has a D-shaped cross section. The second portion 104d may have a suitable cross-section, such as, circular, semi-circular, D-shape, square, etc. In an embodiment, the second portion 104d has a circular cross-section. At least a part of the second portion 104d is disposed within the motor 103. The shaft 104 can be hollow, solid, partially solid, etc. In an embodiment, the shaft 104 is solid. An outer surface of the shaft 104 may be threaded, semi-threaded or smooth. In an embodiment, the shaft 104 has a smooth outer surface. The shaft 104 can be made of a material such as, without limitation, carbon, medium tensile steel, nickel-chromium, chromium-vanadium steel, steel etc. In an embodiment, the shaft 104 is made of steel.
[0044] The gearhead 105 is coupled to the shaft 104 and is configured to rotate in response to the rotation of the motor 103. The gearhead 105 is coupled to the first portion 104c of the shaft 104 according to an embodiment of the present disclosure. Fig. 4b shows a perspective view of the gearhead 105 according to an embodiment. The gearhead 105 has a first end 105a and a second end 105b. The gearhead 105 may have a cross-section of a suitable shape including, without limitation, circular, triangular, hexagonal, square, semi-circular, D shape, etc. In an embodiment, the gearhead 105 has a circular cross-section. The gearhead 105 includes a hole 105c extending from the second end 105b for at least a partial length of the gearhead 105. The hole 105c has a shape corresponding to the shape of the first portion 104c. In the depicted embodiment, the hole 105c extends for the entire length of the gearhead 105 and is D-shaped. The inner surface of the hole 105c may be threaded, semi-threaded or smooth. In an embodiment, the inner surface of the hole 105c has a smooth inner surface. The first portion 104c of the shaft 104 can be coupled to the hole 105c of the gearhead 105 using, for example, welding, screw mechanism, adhesive, snap-fit mechanism, friction fit mechanism, nut-bolt mechanism, etc. In an example implementation, the first portion 104c is coupled to the hole 105c using a friction fit mechanism by inserting the first portion 104c into the hole 105c. The gearhead 105 has at least one tooth 105d provided on a partial circumference of the gearhead 105 towards the first end 105a and having a pitch P2. The at least one tooth 105d is configured to engage with corresponding at least one tooth 102f of the plurality of teeth 102f of the plunger 102. In an embodiment, the at least one tooth 105d includes one tooth 105d (as shown in Fig. 4b). The single tooth 105d assures the quantity of the delivered adhesive to be precise due to its time-specific motion and engagement with the plunger 102. The length of the at least one tooth 105d may be between 0.32 mm and 0.60 mm. In an embodiment, the length of the at least one tooth 105d is 0.32 mm. The gearhead 105 can be made of a material such as, without limitation, ABS, nylon, HDPE, LDPE, PC, carbon, medium tensile steel, nickel-chromium, chromium-vanadium steel, steel, etc. In an embodiment, the gearhead 105 is made of ABS. The gearhead 105 has a pre-defined diameter designed based upon the requirements.
[0045] The coupling of the gearhead 105 and the plunger 102 via the respective teeth forms a rack-and-pinion mechanism and provides a longitudinal motion to the plunger 102 during the operation of the device 100. The rack-and-pinion mechanism and the corresponding longitudinal motion of the plunger 102 is explained herein with reference to the gearhead 105 having one tooth 105d. However, it should not be considered as limiting and its operation for the gearhead 105 having more than one tooth 105d will be apparent to a person skilled in the art, and the same is within the scope of the present disclosure.
[0046] Figs. 5a and 5b illustrate the coupling of the gearhead 105 and the plunger 102 according to an embodiment. As shown, the tooth 105d of the gearhead 105 engages with a corresponding tooth 102f of the plurality of teeth 102f of the plunger 102. In response to the motor 103 rotating in a first direction (in the depicted example, the first direction is the anticlockwise direction), the shaft 104 and gearhead 105 rotate in the first direction due to the torque provided by the motor 103. Consequently, the tooth 105d too rotates in the first direction. Due to the rack-and-pinion mechanism, the tooth 105d exerts force on the corresponding tooth 102f in a distal direction, and as a result, the plunger 102 moves longitudinally in the distal direction by a pre-defined distance, in response to the rotation of the gearhead 105 in the first direction. Once the shaft 104 and hence, the gearhead 105 completes one rotation, the tooth 105d engages the next tooth (proximal to the previously engaged tooth) of the plurality of teeth 102f and moves the plunger 102 longitudinally once more in the distal direction by the pre-defined distance. With every movement of the plunger 102 in the distal direction by the pre-defined distance, the syringe 109 delivers the adhesive into the patient’s vein at a desired delivery rate as explained later. Thus, the coupling of the gearhead 105 and the plunger 102 translates the rotational motion of the motor 103 into a longitudinal motion of the plunger 102. In a similar manger, when the motor 103 rotates in a second direction, the plunger 102 moves longitudinally in a proximal direction.
[0047] The pre-defined distance that the plunger 102 moves upon completion of one rotation by the gearhead 105 is designed based upon the desired delivery rate of delivery of the adhesive and depends upon one or more parameters including the pitch P1 of the plurality of teeth 102f, the pitch P2 of the at least one tooth 105d of the gearhead 105, the diameter D of the gearhead 105 and the rotational speed of the motor 103. The values of the one or more parameters may be chosen depending upon the desired delivery rate. In an example implementation, the desired delivery rate is between 0.1 cc per second and 0.12 cc per second. Accordingly, in an embodiment, the values of the one or more parameters are: P1 = 1.5 mm, P2 = 0 (as the gearhead 105 includes the single tooth 105d, D = 4.84 mm and the rotational speed of the motor 103 = 60 RPM. Consequently, the plunger 102 moves in the distal direction by a distance between 1.2 mm – 1.6 mm (i.e., the predefined distance) depending upon the viscosity of the adhesive for every rotation of the gearhead 105, thereby delivering the adhesive at the desired delivery rate.
[0048] The power source 111 is electrically coupled to the motor 103 and provides power to the motor 103. The power source 111 can be an AC power source or a DC power source depending upon the type of the motor 103. In an embodiment, the power source 111 is a DC power source and includes at least one battery. In an embodiment, the power source 111 includes a 9V battery (depicted in Fig. 1a).
[0049] The control element 110 is configured to control the power from the power source 111 to the motor 103. The control element 110 is electrically coupled to the motor 103 and the power source 111. In an embodiment, the control element 110 is electrically coupled to the motor 103 and the power source 111 such that the motor 103 can be rotated in both the clockwise and the anticlockwise directions. The control element 110 includes at least one mode of operation. In an embodiment, the control element 110 is configurable to be in one of a forward mode, a backward mode and a stop mode. In the forward mode, the control element 110 couples the power source 111 to the motor 103 such that it causes the motor 103 to rotate in the first direction (e.g., in the anticlockwise direction) and the plunger 102 moves in the distal (or forward) direction. In the backward mode, the control element 110 couples the power source 111 to the motor 103 such that the motor 103 rotates in the second direction (e.g., in the clockwise direction) and the plunger 102 moves in the proximal (or backward) direction. In the stop mode, the control element 110 electrically decouples the power source 111 from the motor 103, which causes the motor 103 stops. According to an embodiment, the control element 110 is a rocker switch (as shown in Figs 1a – 1b).
[0050] The control element 110 may be placed at a convenient position in the handle 101 for the user to manipulate the control element 110 easily. In an embodiment, the control element 110 is provided towards a distal end of the stem portion 101f (depicted in Fig. 1b). The stem portion 101f includes an opening to receive the control element 110. In an embodiment, the opening is formed by cut-outs 101a1 and 101b1 (shown in Figs. 2a – 2b) in the left section 101a and the right section 101b, respectively, when the left section 101a and the right section 101b are coupled together. The cut-outs 101b1 and 101a1 have a shape and size corresponding to the shape and size of a cross-section of the control element 110.
[0051] Fig. 6 depict different views of the clamp 106 in accordance with one or more embodiment of the present disclosure. The clamp 106 is used to secure the motor 103 in a place within the handle 101. The clamp 106 includes a frame 106a, and arms 106b. In the depicted embodiment, the frame 106a is generally rectangular, though the frame 106a may have any other suitable shape. The frame 106a at least partially surrounds the motor 103. The arms 106b extend away from opposite sides of the frame 106a. Each intersection of the frame 106a and the arms 106b has holes 106c. The clamp 106 may be placed over the motor 103 and coupled to the holes 106c using suitable fasteners, e.g., screws, passing through the respective hole 106c and the respective hole 106c. The clamp 106 can be made of a material such as, without limitation ABS, nylon, HDPE, LDPE, PC, etc. In an embodiment, the clamp 106 is made of ABS.
[0052] The holder 107 is configured to hold the syringe 109 as explained later. The holder 107 has a proximal end 107c and a distal end 107d (shown in Figs. 5a and 5b). The holder 107 includes a top section 107a and a bottom section 107b coupled together to form the holder 107. Figs. 7a and 7b depict the top section 107a and the bottom section 107b according to one or more embodiments of the present disclosure. The top section 107a and the bottom section 107b are generally semi cylindrical, though they may have any other suitable shape. The top section 107a includes a groove 107a1 extending from the distal end 107d to the proximal end 107c, a coupling section 107a2 provided at the distal end 107d, an interlocking section 107a3 provided at the proximal end 107c, and a plurality of studs 107a4. Similarly, the bottom section 107b includes a groove 107b1 extending from the distal end 107d to the proximal end 107c, a coupling section 107b2 provided at the distal end 107d, an interlocking section 107b3 provided at the proximal end 107c, and a plurality of grooves 107b4. In an embodiment, the grooves 107a1 and 107b1 are semi-circular. The shape and size of the plurality of grooves 107b4 correspond to the shape and size of the plurality of studs 107a4. The top section 107a and bottom section 107b are coupled by mating the plurality of studs 107a4 with the corresponding plurality of grooves 107b4, though any suitable coupling mechanism such as screws, a snap-fit mechanism, etc. can be used. When the top section 107a and the bottom section 107b are coupled, the grooves 107a1 and 107b1 form a channel, the coupling sections 107a2 and 107b2 form a coupling portion having semi-circular grooves on top and bottom side of the channel, and the interlocking sections 107a3 and 107b3 form an interlocking portion, which is generally rectangular, distal to the channel. The channel of the holder 107 is configured to receive at least a portion of the syringe 109 and the head 102c of the plunger 102. The cross-sectional diameter of the channel corresponds to the diameter of the head 102c. The holder 107 can be made of a material such as, without limitation ABS, nylon, HDPE, LDPE, PC, etc. In an embodiment, the holder 107 is made of ABS.
[0053] The proximal end 107c of the holder 107 is coupled to the distal end 101d of the handle 101 as depicted in Figs. 1a - 1b. The holder 107 can be coupled to the handle 101 by any suitable mechanism such as a snap-fit mechanism, a stud-groove coupling mechanism, a roll and twist mechanism, a slide-fit mechanism, push-fit mechanism, etc. In the depicted embodiment, the holder 107 is coupled to the handle 101 by a roll and twist mechanism using the locking hub 108.
[0054] Figs. 8a - 8b depict different views of the locking hub 108 in accordance with one or more embodiment of the present disclosure. The locking hub 108 is configured to lock the handle 101 with the holder 107. In an embodiment, the locking hub 108 is circular, though the locking hub 108 may have any other suitable shape. The locking hub 108 includes a rounded projection 108a, C-shaped edges 108b and a flap 108c. the C-shaped edges are provided on a top and a bottom side of the locking hub 108, and extend longitudinally towards a distal end of the locking hub 108. The C-shaped edges 108b are hollow. Each C-shaped edge 108b has a curved ledge open on one side and closed on the other side such that the open ends of the curved ledges are on opposite sides of the C-shaped edges 108b as depicted in Fig. 8a. Each open end of the curved ledges of C-shaped edges 108b is configured to receive a respective coupling section (one of the coupling sections 107a2 and 107b2 of the holder 107), thereby coupling the locking hub 108 to the holder 107. The rounded projection 108a is provided centrally and extends towards the distal end of the locking hub 108. In an embodiment, the locking hub 108 includes a hole 108d extending for the length of the locking hub 108 and having a cross-section corresponding to the cross-sectional shape of the body 102d of the plunger 102 to facilitate free movement of the plunger 102.
[0055] The flap 108c is provided toward the proximal end of the locking hub 108. The flap 108c fits within notches 101a4 and 101b4 (shown in Figs. 2a – 2b) provided on the left section 101a and the right section 101b, respectively, thereby coupling the locking hub 108 to the handle 101 as depicted in Fig. 1a. The locking hub 108 can be made of a material such as, without limitation ABS nylon, HDPE, LDPE, PC, etc. In an embodiment, the locking hub 108 is made of ABS.
[0056] Fig. 9 shows a side view of the syringe 109. The syringe 109 includes a piston 109a, barrel 109b and flanges 109c. The piston 109a includes a head 109a1 provided at a distal end of the syringe 109 and a plurality of arms 109a2 extending away from the head 109a1 in a proximal direction, and a tail 109a3 at a proximal end of the syringe 109. The head 109a1 is generally cylindrical with a taper towards its proximal end. The plurality of arms 109a2 may have a uniform or a non-uniform width. In the depicted embodiment, the plurality of arms 109a2 have a non-uniform width. The tail 109a3 is shaped as a disc with a circular cross-section. The barrel 109b is tubular with a circular cross-section. The diameter of the barrel 109b corresponds to the diameter of the head 109a1. The barrel 109b may include a plurality of markings (not shown) indicating volumes of the adhesive when loaded into the barrel 109b. The barrel 109b defines a volume indicating the capacity of the syringe 109. The barrel 109b includes an elongated nozzle 109b1 at the distal end of the syringe 109. The nozzle 109b1 has a smaller diameter compared to the diameter of the barrel 109b. A luer lock 109b2 is provided to lock the nozzle 109b1 with, for example, a catheter hub (not shown). When the syringe 109 is loaded in the holder 107, each of the interlocking portions 107a3 and 107b3 are configured to receive a corresponding flange 109c of the flanges 109c of the syringe 109 and the channel of the holder 107 is configured to receive the piston 109a as depicted in Figs. 1a and 1b.
[0057] Fig. 10 illustrates a flowchart of a method 1000 of operating the device 100 according to an embodiment. The device 100 is used during a medical procedure, for example, in the sclerotherapy procedure.
[0058] At step 1001, the syringe 109 is loaded with a suitable adhesive. The syringe 109 with a desired capacity is chosen. In an exemplary implementation, the syringe 109 has the capacity of 3 cc. The piston 109a is stretched away from the barrel 109b to load the syringe 109.
[0059] At step 1002, the syringe 109 is coupled with the holder 107. The loaded syringe 109 is placed into the holder 107. The flanges 109c are placed within the corresponding interlocking sections 107a3 and 107b3. The piston 109a is placed within the groove 107b1 such that a proximal face of the tail 109a3 contacts a distal face of the head 102c of the plunger 102 as depicted in Fig. 1b. The top section107a of the holder 107 is coupled to the bottom portion 107b of the holder 107.
[0060] At step 1003, the motor 103 is switched ON. In an embodiment, the user operates the control element 110 to be in the forward mode. In an example implementation, the user presses a button of the rocker switch towards ‘I’ indicator (as depicted in Fig. 1b) to configure the control element 110 in the forward mode. As a result, the control element 110 electrically couples the power source 111 with the motor 103 such that the motor 103 rotates in the anticlockwise direction. Consequently, the shaft 104 and the gearhead 105 rotate in the anticlockwise direction. The engagement between the plurality of teeth 102f of the plunger 102 and the tooth 105d of the gearhead 105 as described earlier converts the rotational motion into the linear motion and results in the forward motion of the plunger 102 in the distal direction. The head 102c of the plunger 102 pushes the piston 109a in the distal (or forward direction) inside the barrel 109b of the syringe 109. Consequently, the adhesive is delivered inside the affected vein of the patient.
[0061] At step 1004, the motor 103 is switched OFF once the desired amount of the adhesive is delivered into the patient’s vein. In an embodiment, the user operates the control element 110 to be in the stop mode. In an example implementation, the user presses the button of the rocker switch to align with ‘O’ indicator (depicted in Fig. 1b) to configure the control element 110 in the stop mode. As a result, the power source 111 is electrically decoupled from the motor 103, thereby stopping the motor 103. The syringe 109 can then be unloaded from the holder 107.
[0062] During the medical procedure, the user may want to move the plunger 102 in the proximal (or backward) direction (for example, when the head 102c moves beyond a pre-defined distance within the channel of the holder 107). In this case, the user may manipulate the control element 110 to be in the backward mode (e.g., by pressing the rocker switch towards the ‘II’ indicator (shown in Fig. 1b). Consequently, the motor 103 moves in the second direction (e.g., the clockwise direction) and the user pinches the tab 102g and manually pulls the plunger 102 in the backward direction.
[0063] The device 100 can be used for multiple applications. For example, the device 100 can be used for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The device 100 can also be employed to treat adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
[0064] The proposed device presents several advantages over conventional devices. Due to the automatic operation and delivery of precise amount of the adhesive at the desired delivery rate, the device overcomes manual errors associated with conventional sclerotherapy devices and the consequence of delivering incorrect amount of the adhesive. Therefore, the proposed device improves the effectiveness of the sclerotherapy procedure and the patient outcome. Further, the proposed device is very easy to operate (for example, via a simple press of the control element provided in the device) unlike conventional device which require continuous manual operation of a trigger by the user.
[0065] 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) comprising:
a. a motor (103) having a shaft (104) and rotating at a pre-defined rotational speed;
b. a gearhead (105) coupled to the shaft (104) and configured to rotate in response to the rotation of a motor (103), the gearhead (105) comprises at least one tooth (105d) provided on a periphery of the gearhead (105) along a partial circumference of the gearhead (105); and
c. a plunger (102), operatively coupled to the gearhead (105) and a syringe (109) having a liquid, comprising a plurality of teeth (102f), at least one tooth (102f) of the plurality of teeth (102f) operatively engaging with the at least one tooth (105d) of the gearhead (105); the plunger (102) is configured to move linearly in a distal direction in response to the rotation of the gearhead (105) in a first direction and cause the syringe (109) to deliver the liquid into a patient’s body.
2. The device (100) as claimed in claim 1, wherein the plunger (102) comprises:
a. a head (102c) provided at the distal end (102b) of the plunger (102) and configured to push a plunger (109a) of the syringe (109) in response to the linear movement of the plunger (102) in the distal direction; and
b. a body (102d) extending from the head (102c) in a proximal direction, the body (102d) comprising the plurality of teeth (102f) on a medial side of the body (102d) and extending at least for a partial length of the body (102d).
3. The device (100) as claimed in claim 1, wherein the at least one tooth (105d) comprises a tooth (105d).
4. The device (100) as claimed in claim 1, wherein in response to the gearhead (105) completing one rotation in the first direction, the plunger (102) is configured to move linearly in the distal direction by a pre-defined distance, wherein the pre-defined distance depends on one or more of: a pitch ‘P1’ of the plurality of teeth (102f) of the plunger (102), a pitch ‘P2’ of the at least one tooth (105d) of the gearhead (105), a diameter ‘D’ of the gearhead (105) and a rotational speed of the motor (103).
5. The device (100) as claimed in claim 1, wherein the device (100) comprises a control element (110) electrically coupled to a power source (111) and the motor (103), and configured to control the power from the power source (111) to the motor (103).
6. The device (100) as claimed in claim 5, wherein the control element (110) is configurable to be in one of at least a forward mode and a stop mode; wherein in the forward mode, the control element (110) causes the motor (103) to rotate in the first direction, thereby moving the plunger (102) in the proximal direction and wherein, in the stop mode, the control element (110) causes the motor (103) to stop.
7. The device (100) as claimed in claim 1, wherein the motor (103), the gearhead (105) and at least a portion of the plunger (102) are disposed within a handle (101) of the device (100).
8. The device (100) as claimed in claim 7, wherein the handle (101) comprises a channel (112) configured to receive at least a portion of the plunger (102).
9. The device (100) as claimed in claim 7, wherein the device (100) comprises a locking hub (108) configured to lock the handle (101) with a holder (107) configured to hold the syringe (109).
10. The device (100) as claimed in claim 9, wherein the locking hub (108) comprises:
a. C-shaped edges (108b) provided on a top and a bottom side of the locking hub (108) and extending longitudinally towards the distal end of the locking hub (108), each C-shaped edge (108b) of the C-shaped edges (108b) having a curved ledge open on one side and closed on other side, with the open ends of the curved ledges being on opposite sides of the C-shaped edges (108b); each open end of the curved ledges is configured to receive a respective coupling section (107a2, 107b2) of coupling sections (107a2, 107b2) provided on the holder (107), thereby locking the holder (107) with the locking hub (108); and
b. a flap (108c) provided towards a proximal end of the locking hub (108) and configured to fit within notches (101a4, 101b4) provided on the handle (101), thereby locking the handle (101) with the locking hub (108).
11. The device (100) as claimed in claim 1, wherein the device (100) comprises a holder (107) configured to hold the syringe (109).
12. The device (100) as claimed in claim 11, wherein the holder (107) comprises:
a. a channel configured to receive at least a portion of the syringe (109) and a head (102c) of the plunger (102); and
b. interlocking sections (107a3, 107b3) configured to receive a corresponding flange (109c) of flanges (109c) of the syringe (109).
13. The device (100) as claimed in claim 1, wherein the device (100) comprises a controller electrically coupled to the motor (103) and configured to control a rotational speed of the motor (103).