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:
THROMBECTOMY DEVICE
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

 
FIELD OF INVENTION
[001] The present invention relates to the field of medical devices. More specifically, the present invention pertains to a thrombectomy device.
BACKGROUND OF INVENTION
[002] Cardiovascular diseases and related complications are among the leading causes of morbidity and mortality worldwide. One of the critical conditions associated with such diseases is the formation of blood clots or thrombi in blood vessels, which can obstruct blood flow. Blood clots may result from various factors, including calcification of tissues, blood thickening, or aggregation of cells. These clots can lead to life-threatening situations by damaging nearby tissues and vital organs. Common sites for blood clot formation include the heart, lungs, brain, legs, arms, intestines, etc.
[003] Thrombi exhibit a wide range of physical characteristics, including variations in shape, size, and density. They can appear as soft emboli, hard emboli, or calcified emboli, each requiring different treatment approaches. To address the danger posed by these thrombi, medical professionals often rely on a thrombectomy procedure, where a thrombectomy device is employed to remove or aspirate the blood clots, restoring normal blood flow. However, existing thrombectomy devices have significant limitations. For example, the existing thrombectomy devices typically come with fixed dimensions and configurations, which require a user to use multiple devices for different types and sizes of thrombi. This not only complicates the thrombectomy procedure but also increases its cost and time demands.
[004] The existing thrombectomy devices often fail to prevent damage to surrounding tissues during clot removal, as fragmented pieces of the clot can harm nearby structures. Additionally, these devices are ineffective at containing and preventing the leakage of thrombus fragments, leaving a critical issue unaddressed.
[005] Thus, there arises a need for a thrombectomy device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[006] The present invention relates to a thrombectomy device for removing thrombus from a body lumen. The thrombectomy device includes a drive unit with a drive shaft configured to rotate and a rotating shaft coupled to the drive shaft and configured to rotate in response to the rotation of the drive shaft. Further, the thrombectomy device includes a digging element coupled to the rotating shaft and configured to rotate in response to the rotation of the rotating shaft. The digging element includes a central rod and a blade. The blade includes a first helical member extending away from an outer surface of the central rod at a first pre-defined angle (A) and a second helical member coupled to a peripheral edge of the first helical member at a second pre-defined angle (B), the first helical member and the second member forming a channel.
[007] 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
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1 depicts a perspective view of a thrombectomy device 100, in accordance with an embodiment of the present disclosure.
[0010] Fig. 1A depicts a cross-section view of the thrombectomy device 100 without a handle 180, in accordance with an embodiment of the present disclosure.
[0011] Fig. 2 depicts a perspective view of a drive unit 110, in accordance with an embodiment of the present disclosure.
[0012] Fig. 3 and Fig. 3A depict a perspective view of a connecting element 130, in accordance with an embodiment of the present disclosure.
[0013] Fig. 3B depicts a cross-section view of the connecting element 130, in accordance with an embodiment of the present disclosure.
[0014] Fig. 4 depicts a perspective view of a fastener 140, in accordance with an embodiment of the present disclosure.
[0015] Fig. 4A depicts a top view of the fastener 140, in accordance with an embodiment of the present disclosure.
[0016] Fig. 4B depicts a side view of the fastener 140, in accordance with an embodiment of the present disclosure.
[0017] Fig. 5 depicts a perspective of a rotating shaft 150, in accordance with an embodiment of the present disclosure.
[0018] Fig. 5A depicts a cross-section view of the rotating shaft 150, in accordance with an embodiment of the present disclosure.
[0019] Fig. 6 depicts a perspective view of a digging element 170, in accordance with an embodiment of the present disclosure.
[0020] Fig. 6A depicts a cross-sectional view of the digging element 170, in accordance with an embodiment of the present disclosure.
[0021] Fig. 7 illustrates a flowchart representing a method 800 for removing thrombus using the thrombectomy device 100, in accordance with an embodiment of the present disclosure.
[0022] Fig. 8A depicts the digging element 170 of the thrombectomy device 100 positioned in proximity of thrombus 10 located within a blood vessel 20, in accordance with an embodiment of the present disclosure.
[0023] Fig. 8B depicts the digging element 170 initiating the breaking of the thrombus 10 within the blood vessel 20, in accordance with an embodiment of the present disclosure.
[0024] Fig. 8C depicts channelization of fragments thrombus into a channel 177 of the digging element 170, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0025] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] According to an embodiment, the present disclosure relates to a thrombectomy device (interchangeably referred to as a device hereafter) that is configured to remove a blood clot or thrombus (collectively referred to as thrombus hereafter) formed inside a blood vessel by breaking the thrombus into small fragments. In an embodiment, the device includes a drive unit, a rotating shaft, a connecting element, and a digging element. The drive unit is coupled to the rotating shaft through the connecting element. Further, the rotating shaft is coupled to the digging element. The drive unit is configured to provide rotational motion to the digging element through the rotating shaft for breaking the thrombus into fragments.
[0030] In an embodiment, the digging element includes a helical member configured to cut or break the thrombus into small fragments with minimal force. The helical member prevents damage to the surrounding blood vessel walls and reduces the risk of additional complications. According to an embodiment, the helical member has a double-helix structure forming a channel extending for the length of the helical member. The channel acts as a guide for the fragmented thrombus, facilitates the removal of the fragmented thrombus, and prevents the leakage of thrombus fragments into the bloodstream, thereby lowering the risk of blockage in other parts of the vascular system.
[0031] Now referring to the figures, Fig. 1 depicts a perspective view and Fig. 1A depicts a cross-section view of the thrombectomy device 100, in accordance with an embodiment of the present disclosure. The thrombectomy device 100 (interchangeably referred to as device 100 hereafter) is configured to remove blood thrombi from a body's lumen. The thrombus includes clots, or other substances such as platelets, fibrin, and trapped cellular elements that form in a blood vessel and obstruct blood flow. The device 100 includes a drive unit 110, a connecting element 130, a rotating shaft 150, a digging element 170, and a handle 180. The device 100 has a proximal end 100a and a distal end 100b. The handle 180 is provided at the proximal end 100a of the device 100. The digging element 170 is provided at the distal end 100b of the device 100. The digging element 170 is coupled to the rotating shaft 150. The rotating shaft 150 is coupled to the drive unit 110 through the connecting element 130. In an embodiment, the drive unit 110 is configured to provide rotational motion to the digging element 170 via the rotating shaft 150. The rotational motion enables the digging element 170 to break the thrombus.
[0032] In an embodiment, the handle 180 is ergonomically designed to provide a secure and comfortable grip, enabling a medical practitioner to operate the device 100 with precision and ease. The ergonomic shape minimizes hand fatigue during prolonged use and enhances maneuverability, ensuring better control over the device 100. The handle 180 may be made from lightweight yet durable materials, making it suitable for extended medical procedures without compromising on durability. The handle 180 includes a port 182 configured to couple with a suction conduit of a suction system 190. The port 182 ensures a secure connection between the handle 180 and the suction system 190, allowing for efficient removal of debris during the procedure. The suction system 190 may be any system capable of creating a suction force to aspirate thrombus fragments. Additionally, the handle 180 includes a cavity configured to house various components of the device 100, such as the drive unit 110, a battery pack 195, and a control unit (not shown). The control unit is configured to control a rotational speed of the drive unit 110, suction power of the suction system 190, or other operational parameters. The control unit may include a processing unit (e.g., a microcontroller) configured to perform various functions of the control unit and a memory. In some embodiments, the handle 180 may also feature user-friendly buttons, a touchscreen interface, or haptic feedback mechanisms to enhance precision and usability.
[0033] In an embodiment, the suction system 190 is configured to aspirate and remove fragmented thrombosis from the blood vessel, ensuring a clear and unobstructed lumen. In an embodiment, the suction system 190 may include an adjustable vacuum regulator, allowing the medical practitioner to fine-tune the suction force based on the specific procedural requirements. The suction system 190 may be integrated with a collection reservoir for storing extracted material, along with sensors to monitor suction efficiency and detect blockages. In some embodiments, the suction system 190 could be synchronized with imaging modalities, such as ultrasound or fluoroscopy, providing real-time visualization of the thrombus removal process and enhancing procedural accuracy.
[0034] Fig. 2 depicts a perspective view of the drive unit 110, in accordance with an embodiment of the present disclosure. The drive unit 110 is provided within the handle 180. The drive unit 110 is configured to generate rotation movement. The drive unit 110 has a proximal end 110a and a distal end 110b. The drive unit 110 includes a drive shaft 111 configured to rotate. The drive shaft 111 is disposed at the distal end 110b of the drive unit 110. In an embodiment, a portion of the drive shaft 111 extends outside of the handle 180. The drive shaft 111 is coupled to the connecting element 130. The drive shaft 111 is configured to transfer the rotational motion of the drive unit 110 to the connecting element 130. In an embodiment, the drive shaft 111 is provided with a hole 112. The hole 112 is used to lock the drive shaft 111 (and the drive unit 110) with the connecting element 130.
[0035] In an embodiment, the drive shaft 111 may have a cylindrical shape with a uniform cross-section or a tapered profile. The drive unit 110 is coupled to a power source (not shown), e.g., a battery, a battery pack, or an AC power supply. In an embodiment, the battery pack 195 having one or more batteries is provided within the handle 180. The drive unit 110 may be operated by an alternating current or a direct current. In an embodiment, the drive unit 110 includes an AC motor, a DC motor, a dynamo, or the like. In an example implementation, the drive unit 110 includes a DC motor. The drive unit 110 may rotate at a fixed revolutions per minute (RPM) or a variable RPM. In an embodiment, the drive unit 110 has a variable RPM which may be controlled during the thrombectomy procedure depending upon the type of thrombus that is to be removed. This makes the device 100 capable of removing a variety of thrombi. In an example implementation, the drive unit 110 may be controlled to rotate between 2000 RPM to 4000 RPM. The speed (i.e., RPM) of the drive unit 110 may be controlled using the control unit coupled to the drive unit 110.
[0036] Fig. 3, Fig. 3A depict a perspective view of the connecting element 130, and Fig. 3B depicts a cross-section view of the connecting element 130, in accordance with an embodiment of the present disclosure. The connecting element 130 is used to couple the drive shaft 111 with the rotating shaft 150. The connecting element 130 has a proximal end 130a and a distal end 130b. The connecting element 130 is coupled with the drive shaft 111 at the proximal end 130a and the rotating shaft 150 at the distal end 130b. The connecting element 130 is configured to rotate in response to the rotation of the drive shaft 111 and is configured to transfer the rotational motion to the rotating shaft 150, causing the rotating shaft 150 to rotate in response to the rotation of the drive shaft 111 and the connecting element 130. In an embodiment, the connecting element 130 has a cylindrical shape. Alternatively, the connecting element 130 may have any other suitable shape. In an embodiment, the connecting element 130 may be made of a biocompatible material including, but not limited to stainless steel (e.g., SS304, SS316), acrylonitrile butadiene styrene (ABS), etc. In an embodiment, the connecting element 130 is made of ABS.
[0037] In an embodiment, the connecting element 130 includes a first hole 132a, a second hole 133a, and a third hole 131a. The first hole 132a is provided at a proximal face 132 of the connecting element 130. The first hole 132a extends longitudinally towards the distal end 130b of the connecting element 130 for a partial length of the connecting element 130. The first hole 132a is configured to receive the drive shaft 111, coupling the drive shaft 111 with the connecting element 130 via a fastener 140. The diameter of the first hole 132a corresponds to the diameter of the drive shaft 111. In an embodiment, the first hole 132a extends to the second hole 133a. In another embodiment, a distal end of the first hole 132a and a proximal end of the second hole 133a may be separated by a distance.
[0038] The second hole 133a is provided on a distal face 133 of the connecting element 130. The second hole 133a extends longitudinally towards the proximal end 130a of the connecting element 130. The second hole 133a is configured to receive a portion of the rotating shaft 150. The second hole 133a may be threaded, partially threaded, or smooth. In an embodiment, the second hole 133a is provided with internal threads 133b.
[0039] The third hole 131a is provided on an outer surface 131 towards the proximal end 130a of the connecting element 130. The third hole 131a extends to the first hole 132a and is perpendicular to the first hole 132a. The third hole 131a is configured to receive the fastener 140. The third hole 131a is used to lock the drive shaft 111 (and the drive unit 110) with the connecting element 130. The third hole 131a may be threaded, partially threaded or smooth. In an embodiment, the third hole 131a is provided with internal threads 131b along the length of the third hole 131a. In an embodiment, when assembled, the third hole 131a aligns with the hole 112 of the drive shaft 111.
[0040] According to an embodiment, the connecting element 130 may be coupled to the drive shaft 111 via a threaded coupling. For example, the first hole 132a may be provided with internal threads (not shown) configured to mate with corresponding external threads (not shown) provided on the drive shaft 111. In an embodiment, the connecting element 130 and the drive shaft 111 are coupled with the help of the fastener 140. The fastener 140 provides a secure coupling between the drive shaft 111 and the connecting element 130, and reduces the chances of relative motion therebetween, thereby providing a smooth motion transfer from the drive shaft 111 to the connecting element 130. The fastener 140 may be a screw, a pin, a rivet, a bolt, or the like, capable of locking the drive shaft 111 with the connecting element 130.
[0041] Figs. 4, 4A to 4B depict multiple views of the fastener 140, in accordance with an embodiment of the present disclosure. The fastener 140 has a top end 140a and a bottom end 140b. The fastener 140 includes a body 142. The body 142 is configured to reside within the third hole 131a of the connecting element 130 and the hole 112 of the drive shaft 111. In an embodiment, the body 142 may be cylindrical with a uniform diameter as shown in Fig. 4B. The diameter of the third hole 131a and the diameter of the hole 112 of the drive shaft 111 corresponds to the diameter of the body 142. In another embodiment, the body 142 may have a generally cylindrical shape with a tapered diameter (e.g., frustum-shaped), for example, the diameter of the body 142 may gradually decrease from the top end 140a to the bottom end 140b. The third hole 131a and the hole 112 of the drive shaft 111 may be shaped and dimensioned accordingly. The outer surface of the body 142 may be smooth, semi-threaded, or fully-threaded. In one embodiment, the fastener 140 includes threads 143 provided on an outer surface of the body 142 from the top end 140a to the bottom end 140b. The threads 143 of the fastener 140 are configured to mate with the internal threads 131b of the third hole 131a and the threads provided in the hole 112 of the drive shaft 111.
[0042] In an embodiment, the fastener 140 may include an aperture 141 provided on a top surface of the fastener 140 and extending into the body 142 for a pre-defined distance. The aperture 141 may have a shape including, but not limited to, circular, oval, hexagonal, pentagonal, or other polygonal configurations. In one embodiment, the aperture 141 has a hexagonal shape. The aperture 141 enables a user to hold and manipulate the fastener 140 using an external tool, such as a screwdriver, to assemble the fastener 140 with the connecting element 130. In an embodiment, the fastener 140 may be made of a biocompatible material including, but not limited to, stainless steel (e.g., SS316, SS304), nitinol, etc. In one embodiment, the fastener 140 is made of SS316.
[0043] An embodiment of coupling the connecting element 130 and the drive shaft 111 with each other is explained below. The drive shaft 111 is inserted into the first hole 132a until the hole 112 of the drive shaft 111 and the third hole 131a align with each other. The fastener 140 is held by engaging the external tool with the aperture 141. The threads 143 is engaged with the internal threads 131b of the third hole 131a. The fastener 140 is rotated until at least a portion of the body 142 resides in the hole 112 of the drive shaft 111 and the threads 143 mate with the threads in the hole 112 of the drive shaft 111, to fasten the fastener 140 securely within the third hole 131a and the hole 112 of the drive shaft 111. This ensures a robust coupling between the drive unit 110 and the connecting element 130 and prevents any loosening or unwanted relative movement between them during the operation of the device 100.
[0044] Further, the length of the fastener 140 may be designed such that when assembled with the connecting element 130, the top surface of the fastener 140 aligns with the outer surface 131 of the connecting element 130. This facilitates a seamless and flush assembly, reducing the risk of snagging, improving the overall aesthetic of the structure, and ensuring better load distribution or mechanical integrity between the connected components. In an embodiment, the drive shaft 111 may be provided with threads configured to engage with threads provided in the first hole 132a of the connecting element 130.
[0045] Fig. 5 depicts a perspective view of the rotating shaft 150 and Fig. 5A depicts a cross-section view of the rotating shaft 150, in accordance with an embodiment of the present disclosure. The rotating shaft 150 coupled to the drive shaft 111 and configured to rotate the digging element 170 by transferring the rotational motion of the drive unit 110. The rotating shaft 150 has a proximal end 150a and a distal end 150b. The proximal end 150a of the rotating shaft 150 is coupled to the connecting element 130. The distal end 150b of the rotating shaft 150 is coupled to the digging element 170. In an embodiment, the rotating shaft 150 is flexible, allowing it to navigate and conform to the shape of the blood vessel or other confined pathways. Fig. 1 depicts the flexibility of the rotating shaft 150 in a representative manner. This flexibility enhances maneuverability and ensures smooth operation even in curved or tortuous pathways. In an embodiment, the rotating shaft 150 is coiled having at least one coil 152a (shown in Fig. 1) extending at least partially for a length of the rotating shaft 150. The at least one coil 152a may be arranged in a helical or tightly wound pattern, allowing the rotating shaft 150 to bend and flex while maintaining structural integrity and efficient torque transmission. The coiled structure of the rotating shaft 150 helps in absorbing external forces and minimizing mechanical strain, thereby improving the durability and operational reliability of the rotating shaft 150. It should be noted that for reasons of clarity, the at least one coil 152a is not shown in Figs. 5 and 5A.
[0046] In an embodiment, the rotating shaft 150 includes a first coupling portion 151 provided at the distal end 150b of the rotating shaft 150 and a second coupling portion 153 provided at the proximal end 150a of the rotating shaft 150. Further, the rotating shaft 150 includes a shank 152 between the first coupling portion 151 and the second coupling portion 153. In an embodiment, the shank 152, the first coupling portion 151, and the second coupling portion 153 may have a cylindrical shape, and may have the same or different diameters. In an embodiment, the first coupling portion 151 has a larger diameter than the shank 152, and the second coupling portion 153 has a smaller diameter than the diameter of the shank 152. In an embodiment, the rotating shaft 150 may be made of a biocompatible material including, but not limited to, polytetrafluoroethylene (PTFE), polyether block amide (PEBAX), stainless steel (e.g., SS316), etc. In one embodiment, the rotating shaft 150 is made of SS316. In an embodiment, the shank 152 may be made of at least one coil 152a that enables flexibility in the shank 152, allowing maneuverability and ensuring smooth operation even in curved or tortuous pathways.
[0047] The first coupling portion 151 is removably coupled to the digging element 170. In an embodiment, the first coupling portion 151 includes a coupling groove 155 that extends longitudinally towards the proximal end 150a of the rotating shaft 150 for at least a partial length of the first coupling portion 151. The coupling groove 155 is used to couple the rotating shaft 150 with the digging element 170. The coupling groove 155 may be threaded, partially threaded, or smooth. In an embodiment, the coupling groove 155 has threads 155a.
[0048] In an embodiment, the second coupling portion 153 is configured to reside in and is coupled with, the second hole 133a of the connecting element 130, using for example, threaded coupling, bonding, clamping, etc. The diameter of the second coupling portion 153 corresponds to the diameter of the second hole 133a of the connecting element 130. The second coupling portion 153 may be threaded, partially threaded, or smooth. In an embodiment, the second coupling portion 153 has threads 153a configured to mate with the internal threads 133b of the second hole 133a of the connecting element 130, thereby coupling the rotating shaft 150 with the connecting element 130 and ensuring a secure connection. The threaded coupling between the second coupling portion 153 and the second hole 133a of the connecting element 130 facilitates a reliable and firm coupling. Though in the depicted embodiment, the rotating shaft 150 is coupled to the drive shaft 111 via the connecting element 130, it should not be considered as limiting. In another embodiment, the rotating shaft 150 may be coupled directly with the drive shaft 111 using, for example, threaded coupling. Accordingly, the drive shaft 111 may be provided with outer threads (not shown) configured to engage with inner threads (not shown) provided in the second coupling portion 153 or in the shank 152. The coupling of the rotating shaft 150 and drive shaft 111 via the connecting element 130 ensures a smooth transfer of motion from the drive shaft 111 to the rotating shaft 150. The connecting element 130 also prevents vibrations in the drive unit 110 from passing to the rotating shaft 150.
[0049] Fig. 6 depicts a perspective view of the digging element 170 and Fig. 6A depicts a cross-sectional view of the digging element 170, in accordance with an embodiment of the present disclosure. The digging element 170 is coupled (fixedly or removably) to the rotating shaft 150. Preferably, the digging element 170 is removably coupled to the rotating shaft 150. The digging element 170 is configured to rotate in response to the rotation of the rotating shaft 150. The removable coupling between the digging element 170 and the rotating shaft 150 enables a medical practitioner to easily couple the digging elements 170 of different sizes to the rotating shaft 150 according to the procedural requirements. This makes the device 100 universal and capable of removing thrombi of different types and sizes, enhancing the versatility and usability of the device 100 and decreasing the overall costs.
[0050] The digging element 170 has a proximal end 170a and a distal end 170b. The digging element 170 includes a central rod 171 and a blade 175 provided on an outer surface of the central rod 171 and extending along at least a partial length of the central rod 171. In an embodiment, the blade 175 extends for the entire length of the central rod 171. The digging element 170 includes a coupling portion 173 at the proximal end 170a. The coupling portion 173 is configured to reside in and is coupled with, the coupling groove 155 of the rotating shaft 150 using a technique, such as, without limitation, threaded coupling, bonding, clamping, etc. The coupling portion 173 may be threaded, partially threaded, or smooth. In an embodiment, the coupling portion 173 has threads 173a configured to mate with the threads 155a of the coupling groove 155, ensuring a secure connection. The threaded coupling between the coupling groove 155 of the rotating shaft 150 and the coupling portion 173 of the digging element 170 facilitates a reliable and firm coupling. The diameter of the coupling portion 173 corresponds to the diameter of the coupling groove 155 of the rotating shaft 150.
[0051] The central rod 171 may be cylindrical having a uniform diameter of conical (or frustum-shaped). In an embodiment, the central rod 171 has a conical shape such that the diameter of the central rod 171 decreases gradually from the proximal end 170a to the distal end 170b of the digging element 170. The tapered shape of the central rod 171 facilitates easy penetration of the digging element 170 into the thrombi, thereby enabling easy removal of the thrombi. The central rod 171 provides strength and stability to the blade 175. The dimensions of the central rod 171 may be designed according to, for example, the size and type of the thrombi, the patient’s anatomy, and the requirements of the procedure. In an embodiment, the diameter of the central rod 171 at the proximal end 170a may range between 6 mm and 20 mm, and the diameter of the central rod 171 at the distal end 170b of the digging element 170 may range from 2 mm to 10 mm. In an example implementation, the diameter of the central rod 171 at the proximal end 170a is 12 mm, and at the distal end 170b is 4 mm. In an embodiment, the length of the central rod 171 may range between 5 mm and 50 mm. In an example implementation, the length of the central rod 171 is 20 mm. The central rod 171 may be made of a biocompatible material including, but not limited to, stainless steel (e.g., SS316, SS304), nitinol, polymer, etc. In one embodiment, the central rod 171 is made of SS316.
[0052] The blade 175 is configured to break and/or cut the thrombus into smaller fragments within the blood vessel 20. In an embodiment, the blade 175 has a double-helical structure and includes a first helical member 175a and a second helical member 175b. The first helical member 175a extends away from the surface of the central rod 171 at a first pre-defined angle A. The first pre-defined angle A may range between 10° and 120°, more specifically, between 15° and 90°. In an example implementation, the first pre-defined angle A is 90°, which helps in easy removal of the thrombi and reduces the chances of damage to the blood vessels from which the thrombus is being removed. The second helical member 175b is integrally coupled to a peripheral edge 175c of the first helical member 175a and extends in a distal direction of the digging element 170 from the peripheral edge 175c of the first helical member 175a at a second pre-defined angle B, forming a continuous double-helical structure along the length of the central rod 171. In an embodiment, the second predefined angle B may range from 10° to 120°, more specifically, from 15° to 90°. In an example implementation, the second pre-defined angle B is 90°, which helps in easy removal of the thrombi and reduces the chances of damage to the blood vessels from which the thrombus is being removed.
[0053] The second helical member 175b and the first helical member 175a form a channel 177 extending between the distal end 170b and the proximal end 170a. The rotational motion of the blade 175 channelizes the fragmented thrombus into the channel 177. The channel 177 allows the fragmented thrombus to slide down the surface of the channel 177 and be aspirated out of the blood vessel 20. The channel 177 securely holds the fragments. The inner surface of the second helical member 175b serves as a barrier, preventing the fragments from escaping the channel 177. This ensures that the device 100 effectively captures the fragments and eliminates the risk of leakage.
[0054] The dimensions of the digging element 170 may be chosen based upon the size of a target vessel through which the thrombus is to be removed. In an embodiment, the external diameter of the blade 175 decreases gradually from the proximal end 170a to the distal end 170b of the digging element 170. This ensures easy penetration through the patient’s vasculature as well as cutting and removal of the thrombi more easily. The pitch of the first helical member 175a and the second helical member 175b may be uniform (as depicted in Fig. 6A) or may vary along the longitudinal axis of the central rod 171. The pitch of the second helical member 175b aligns with the pitch of the first helical member 175a to form the continuous channel 177 without any gaps. According to an embodiment, the width W of the second helical member 175b is equal to half of the pitch of the first helical member 175a. This ensures the capture and gradual transfer of the thrombus for further removal. In an embodiment, the pitch of the first helical member 175a and the second helical member 175b may range from 1 mm to 5 mm. In an example implementation, the pitch of the first helical member 175a and the second helical member 175b is 2.5 mm. In an embodiment, the blade 175 may be made of a biocompatible material including, but not limited to, stainless steel (e.g., SS316, SS304), nitinol, polymer, etc. In one embodiment, the blade 175 is made of SS316.
[0055] Fig. 7 depicts a flowchart representing a method 700 for removing blood clots, or thrombi from a blood vessel 20 using the device 100, in accordance with an embodiment of the present disclosure. The method 700 may be performed under fluoroscopic guidance or any other guiding technique. At step 701, Creating, a vascular access point in the patient's body using a needle. The access point is selected based on the patient's anatomy and the location of the thrombus.
[0056] At step 703, an introducer sheath along with a dilator is inserted into the patient’s body through the access point. The introducer sheath acts as a conduit to facilitate the smooth passage of other medical devices into the blood vessel 20 while minimizing trauma to the vessel walls. The dilator helps in expanding the vessel to accommodate the introducer sheath effectively.
[0057] At step 705, a guidewire is inserted through the introducer sheath. The guidewire serves as a navigational tool, allowing controlled movement of catheters and other instruments toward the target site while maintaining vascular integrity.
[0058] At step 707, the dilator is removed while keeping the guidewire in place. This step ensures that the guidewire remains within the blood vessel to guide further instrument placement without causing vessel trauma or misalignment.
[0059] At step 709, a guiding catheter along with a dilator is introduced over the guidewire. The guiding catheter provides a passage for the rotating shaft 150 and the digging element 170. Once the guiding catheter reaches the intended location, the guidewire and dilator are carefully removed.
[0060] At step 711, the digging element 170 is navigated to the target site within the blood vessel 20. The target site corresponds to a location of thrombus 10 within the blood vessel 20 and the distal end 170b of the digging element 170 is in close proximity to the thrombus 10 as depicted in Fig. 8A. The position of the digging element 170 may be further adjusted such that the distal end 170b of the digging element 170 may contact the thrombus 10.
[0061] At step 713, once the distal end 170b of the digging element 170 contacts the thrombus 10, the device 100 is activated by actuating the drive unit 110. For example, the medical practitioner activates the drive unit 110 by pressing a switch to supply power to the drive unit 110. Upon actuation, the drive unit 110 and the drive shaft 111 start rotating. As explained earlier, the rotational motion of the drive shaft 111 is transferred to the digging element 170 through the connecting element 130 and the rotating shaft 150, causing the digging element 170 to rotate. When the blade 175 of the digging element 170 engages the thrombus 10, the rotation of the blade 175 applies a force (or cutting motion) on the thrombus 10, breaking the thrombus 10 into smaller fragments (as depicted in Fig. 8B). The rotational motion of the digging element 170 also enables the digging element 170 to penetrate further into the thrombus 10 and dislodge the thrombus material into smaller fragments. The fragmented thrombus 10 is collected in the channel 177 of the blade 175. The rotational motion of the digging element 170 and the double-helical design of the blade 175 ensures that the fragmented thrombus 10 is directed towards the proximal end 170a of the digging element 170 (as shown in Fig. 8C).
[0062] At step 715, the fragments of the thrombus 10 (also referred to as fragmented thrombus) are aspirated from the proximal end 170a of the digging element 170 through the suction system 190. The channel 177 prevents leaking of the fragmented thrombi into the blood vessel 20 due to the inner surface of the second helical member 175b. This allows the aspiration procedure to be performed simultaneously with the breaking of the thrombus 10. This reduces the time for the thrombectomy procedure, decreases its complexity, and enhances the procedural efficiency.
[0063] At step 717, the digging element 170 is withdrawn from the patient’s body, completing the thrombectomy procedure.
[0064] Thus, the rotating action enables the digging element 170 to penetrate and dislodge the thrombus material into smaller fragments. The fragmentation helps to alleviate the blockage caused by the thrombus 10, enabling a smoother blood flow through the blood vessel 20. The fragmented thrombus 10 is aspirated and the thrombus 10 is entirely cleared, restoring proper blood circulation within the blood vessel 20.
[0065] The device of the present disclosure removes blood clots, reducing the risk of serious complications like strokes, heart attacks, or organ damage. The proposed device offers several advantages over conventional devices. Due to the double-helical structure of the blade, the device prevents the leakage of fragments of the thrombus during the procedure unlike conventional devices. This minimizes the risk of downstream embolization, where dislodged fragments could block smaller blood vessels, leading to additional complications. Consequently, the prevention of leakage enhances the overall safety and efficacy of the procedure, reducing the likelihood of secondary clot formation. Additionally, the device prevents damage to surrounding tissues, by removing the thrombus with precision, reducing the risk of injury to nearby tissues. The proposed device is also capable of removing different types of emboli with a single device. Further, the device enables the clot breaking and the aspiration procedures to be performed simultaneously, thereby reducing procedural complexity and increasing its efficiency. Overall, the device of the present disclosure is a safer, more effective, and cost-efficient option for treating blood clots as compared to a conventional device.
[0066] 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 thrombectomy device (100) for removing thrombus from a body lumen, the thrombectomy device (100) comprising:
a. a drive unit (110) having a drive shaft (111) configured to rotate;
b. a rotating shaft (150) coupled to the drive shaft (111) and configured to rotate in response to the rotation of the drive shaft (111);
c. a digging element (170) coupled to the rotating shaft (150) and configured to rotate in response to the rotation of the rotating shaft (150), the digging element (170) comprising:
i. a central rod (171); and
ii. a blade (175) comprising a first helical member (175a) extending away from an outer surface of the central rod (171) at a first pre-defined angle (A) and a second helical member (175b) coupled to a peripheral edge (175c) of the first helical member (175a) at a second pre-defined angle (B), the first helical member (175a) and the second member (175b) forming a channel (177).
2. The thrombectomy device (100) as claimed in claim 1, wherein the rotating shaft (150) comprises a first coupling portion (151) removably coupled to the digging element (170).
3. The thrombectomy device (100) as claimed in claim 2, wherein the first coupling portion (151) comprises a coupling groove (155) having internal threads (155a) configured to mate with threads (173a) of a coupling portion (173) of the digging element (170)
4. The thrombectomy device (100) as claimed in claim 1, wherein the thrombectomy device (100) comprises a connecting element (130) to couple the rotating shaft (150) with the drive shaft (111), wherein the connecting element (130) is configured to transfer the rotational motion of the drive shaft (111) to the rotating shaft (150).
5. The thrombectomy device (100) as claimed in claim 4, wherein the connecting element (130) comprises:
a. a first hole (132a) extending longitudinally from a proximal end (130a) towards a distal end (130b) of the connecting element (130) and configured to receive the drive shaft (111); and
b. a second hole (133a) extending longitudinally from the distal end (130b) towards the proximal end (130a) of the connecting element (130) and configured to receive a second coupling portion (153) of the rotating shaft (150).
6. The thrombectomy device (100) as claimed in claim 5, wherein the connecting element (130) comprises a third hole (131a) provided on an outer surface (131) of the connecting element (130) and extending perpendicularly to the first hole (132a), the first hole (132a) is configured to receive a fastener (140).
7. The thrombectomy device (100) as claimed in claim 5, wherein the second hole (133a) is provided with internal threads 133b configured to mate with threads (153a) of the second coupling portion (153) of the rotating shaft (150).
8. The thrombectomy device (100) as claimed in claim 2, wherein the thrombectomy device (100) comprises a handle (180) comprising:
a. a cavity adapted to accommodate the drive unit (110);
b. a port (182) coupled to a suction system (190) configured to aspirate fragmented thrombus.
9. The thrombectomy device (100) as claimed in claim 1, wherein the rotating shaft (150) is coiled having at least one coil (152a) extending at least partially for a length of the rotating shaft (150).
10. The thrombectomy device (100) as claimed in claim 1, wherein the thrombectomy device (100) comprises a battery pack (195) coupled to the drive unit (110) and configured to supply power to the drive unit (110).
11. The thrombectomy device (100) as claimed in claim 1, wherein the first pre-defined angle A ranges between 10° and 120°.
12. The thrombectomy device (100) as claimed in claim 1, wherein the first pre-defined angle A is 90°.
13. The thrombectomy device (100) as claimed in claim 1, wherein the first pre-defined angle B ranges between 10° and 120°.
14. The thrombectomy device (100) as claimed in claim 1, wherein the first pre-defined angle B is 90°.
15. The thrombectomy device (100) as claimed in claim 1, wherein a width (W) of the second helical member (175b) is equal to half of a pitch of the first helical member (175a).
16. The thrombectomy device (100) as claimed in claim 1, wherein the drive unit (110) comprises one of: an AC motor, a DC motor, or a dynamo.