Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
DEVICE FOR EXTRACTING AN IMPLANTED LEAD

2. APPLICANT:
Name : Meril Corporation (I) Private Limited
Nationality : Indian
Address : Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:
 
FIELD OF INVENTION
[001] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a device for extracting an implanted lead from a patient’s body.
BACKGROUND OF INVENTION
[002] Cardiac implantable electronic devices (CIEDs), such as a pacemaker and implantable cardioverter defibrillator (ICD), are commonly used to manage arrhythmias and other cardiac conditions. These devices are connected to the heart via one or more implanted leads that are flexible, insulated wires that transmit electrical impulses between the device and cardiac tissue. While these leads are designed to remain in place for extended periods, clinical circumstances may necessitate their removal. Such scenarios include lead malfunction, infection, upgrade of the implanted system, routine replacement, or complications arising from chronic implantation.
[003] Over time, the implanted lead may become encapsulated by fibrotic tissue or enmeshed in calcified deposits due to biological responses within the cardiovascular system. These adhesions often occur at multiple sites along the lead, including venous entry points, vascular walls, and cardiac structures. As a result, extracting these leads becomes a technically challenging procedure that requires a specialized device capable of safely detaching the implanted lead without damaging surrounding tissue.
[004] Existing lead extraction devices typically employ mechanical or energy-assisted sheaths, such as laser-based tools that dissect or ablate the calcified or fibrotic tissue binding the leads. However, these existing devices pose a considerable safety risk. The use of high-energy elements increases the potential for vascular injury, perforation, or bleeding, particularly in regions with severe calcification or anatomical vulnerability. Additionally, many conventional devices require significant manual force or rotational input, which not only demands a high level of operator expertise but also contributes to fatigue and variable procedural outcomes.
[005] Beyond safety concerns, the design of most existing extraction devices contributes to high procedural costs and environmental burden. Conventional devices are entirely disposable, intended for single use, which significantly increases the cost per procedure and generates substantial medical waste. This raises concerns regarding long-term sustainability, particularly in healthcare settings with high procedural volume or limited resources.
[006] Thus, there arises a need for a lead extraction device that overcomes the limitations associated with the conventional lead extraction devices.
SUMMARY OF INVENTION
[007] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[008] In an exemplary embodiment, the present disclosure relates to a device for the extraction of an implanted lead. The device includes a handle, a cutting assembly, an extraction assembly, and a drive assembly. The cutting assembly is removably coupled to the handle. The cutting assembly includes a sheath and a cutting element coupled to the sheath. The cutting assembly is configured to dissect fibrotic or calcified tissue surrounding the implanted lead. The extraction assembly is removably coupled to the handle and includes a guidewire and a winder. The guidewire is coupled with the implanted lead and the winder. The winder is configured to facilitate the extraction of the implanted lead. The drive assembly is coupled to the cutting assembly and the extraction assembly. The drive assembly includes at least one motor configured to selectively provide a first rotational actuation to the sheath to rotate the cutting element and a second rotational actuation to the winder to extract the implanted lead by coiling the guidewire.
BRIEF DESCRIPTION OF DRAWING
[009] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0010] Fig. 1A depicts a perspective view of a device 100, according to an embodiment of the present disclosure.
[0011] Figs. 1B depicts an exploded view of the device 100 showing various assemblies of the device 100, according to an embodiment of the present disclosure.
[0012] Fig. 1C depicts an exploded view of the device 100, according to an embodiment of the present disclosure.
[0013] Fig. 2 depicts a perspective view of a cutting assembly 110 of the device 100, according to an embodiment of the present disclosure.
[0014] Figs. 2A1 and 2A2 depict a perspective view of a sheath coupler 250 of the cutting assembly 110, according to an embodiment of the present disclosure.
[0015] Fig. 2A3 depicts a sectional view of the sheath couple 250 of the cutting assembly 110, according to an embodiment of the present disclosure.
[0016] Fig. 2B depicts a perspective view of a sheath 220 of the cutting assembly 110, according to an embodiment of the present disclosure.
[0017] Fig. 2C depicts a perspective view of a cutting element 200 of the cutting assembly 110, according to an embodiment of the present disclosure.
[0018] Fig. 2D depicts a cross-sectional view of a distal portion of the device 100, according to an embodiment of the present disclosure.
[0019] Fig. 3A depicts a perspective view of an extraction assembly 120 of the device 100, according to an embodiment of the present disclosure.
[0020] Fig. 3B depicts a sectional view of the extraction assembly 120, according to an embodiment of the present disclosure.
[0021] Fig. 3C depicts a sectional view of a chamber 300 of the extraction assembly, according to an embodiment of the present disclosure.
[0022] Fig. 4 depicts a perspective view of coupling between an implanted lead 10 and a guidewire 350, according to an embodiment of the present disclosure.
[0023] Fig. 5 depicts a perspective view of a support roller 360 of the device 100, according to an embodiment of the present disclosure.
[0024] Fig. 6 depicts a perspective view of a winder 400 of the extraction assembly 120, according to an embodiment of the present disclosure.
[0025] Fig. 7A depicts a perspective view of a handle 500 of the device 100, according to an embodiment of the present disclosure.
[0026] Fig. 7B depicts an exploded view of the handle 500 of the device 100, according to an embodiment of the present disclosure.
[0027] Fig. 8 depicts a schematic view of a drive assembly 130 of the device 100, according to an embodiment of the present disclosure.
[0028] Fig. 9 depicts a cross-sectional view of a proximal portion of the device 100, according to an embodiment of the present disclosure.
[0029] Figs. 10A – 10D depict steps of assembling the device 100, according to an embodiment of the present disclosure.
[0030] Fig. 11 depicts a flowchart of a method 1000 for working of the device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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 the embodiments as set forth hereinafter.
[0035] The present disclosure relates to a device for the extraction of an implanted lead from a heart of a patient. The device is configured to safely dissect and extract an implanted lead from calcified or fibrotically adhered tissue of the heart. In an embodiment, the device includes a cutting assembly, an extraction assembly, and a drive assembly. The drive assembly is operationally coupled to the cutting assembly and the extraction assembly. The drive assembly includes at least one motor configured to selectively provide rotational actuation to a cutting element of the cutting assembly and a winder of the extraction assembly for winding a guidewire coupled to the lead.
[0036] The drive assembly is configured to provide controlled rotational actuation to both the cutting element and the winder. The rotational actuation enables the cutting element to dissect calcified or fibrotic tissue surrounding the implanted lead and further allows the winder to wind the guidewire to apply tension for lead extraction. The controlled rotation reduces reliance on manual force, thereby minimizing operator fatigue and enhancing procedural consistency. The device mitigates risks such as perforation, excessive bleeding, and thermal injury. The drive assembly offers enhanced control and adaptability, particularly in complex anatomical scenarios or in cases involving chronically implanted leads.
[0037] The device incorporates a hybrid configuration including both reusable and disposable components, thereby improving cost-effectiveness, reducing medical waste, and enhancing clinical workflow. The device enhances procedural safety, minimizes intraoperative risks, and reduces user fatigue. The minimally invasive approach provides a reliable and efficient solution for the extraction of the device upgrade or calcified tissue adhesion. Overall, the device contributes to improved clinical outcomes and elevated patient safety.
[0038] Now referring to the figures, Fig. 1A-1C depict various views of a device 100 that is configured to extract an implanted lead. The device 100 is designed to safely dissect and extract an implanted lead that adheres to surrounding tissue, particularly in cases involving calcification or fibrosis encapsulation. The device 100 may be used in a variety of clinical conditions including, but not limited to, the extraction of pacemaker leads, implantable cardioverter defibrillator (ICD) leads, and leads of other intravascular cardiac implants that require removal due to infection, malfunction, device upgrades, or lead-related complications such as calcification or fibrotic adhesion. The device 100 offers a minimally invasive alternative to surgical procedure for removing implanted lead and can be employed in interventional cardiology, electrophysiology, and cardiovascular surgical procedures.
[0039] The device 100 includes a proximal end 100a and a distal end 100b. In an embodiment, the device 100 includes a cutting assembly 110, an extraction assembly 120, a drive assembly 130, and a handle 500. The cutting assembly 110 and the extraction assembly 120 are removably coupled to the handle 500. The drive assembly 130 is disposed within the handle 500 as depicted in Fig. 1C. The drive assembly 130 is operationally coupled to the cutting assembly 110 and the extraction assembly 120. In an embodiment, the handle 500 and some elements (explained later) of the drive assembly 130 are reusable components, designed for durability and repeated use across multiple procedures. The cutting unit 110 and the extraction unit 120 define a fluid path configured to convey a biological fluid from a cutting element 200 to a chamber 300 via a sheath 220, such that the fluid path is isolated from the handle 500, thereby rendering the handle 500 is reusable. The cutting assembly 110 and the extraction assembly 120 are disposable. The disposable configuration ensures that sterile, single-use cutting assembly 110 and extraction assembly 120 are employed for every procedure, thereby maintaining hygiene standards, minimizing the risk of cross-contamination, and eliminating the need for complex sterilization protocols. The separation of reusable and disposable components also enhances cost-effectiveness and procedural efficiency.
[0040] Fig. 2 depicts a perspective view of the cutting assembly 110, in accordance with an embodiment of the present disclosure. The cutting assembly 110 is configured to dissect the calcified or fibrotic tissue surrounding the implanted lead. In an embodiment, the cutting assembly 110 includes the cutting element 200, a sheath 220, and a sheath coupler 250. The cutting element 200 is coupled to the sheath 220.
[0041] Figs. 2A1-2A3 depict various views of the sheath coupler 250 of the cutting assembly 110, according to an embodiment of the present disclosure. The sheath coupler 250 serves as a structural and functional interface between the sheath 220 and the drive assembly 130. The sheath coupler 250 includes a proximal end 250a removably coupled to handle 500 and a distal end 250b coupled to a proximal end 220a of the sheath 220. In other words, the sheath coupler 250 is coupled to a proximal end 220a of the sheath 220 and removably coupled to the handle 500. The sheath coupler 250 is adapted to house a portion of the drive assembly 130. The shape of the sheath coupler 250 may be cylindrical, tubular, polygonal, cuboidal, etc., based on ergonomic and functional requirements. The cross-sectional profile may remain uniform or taper slightly along the length of the sheath coupler 250 for optimized coupling with internal and external components. The sheath coupler 250 is fabricated from biocompatible materials such as polyether (PEEK), polyamide (nylon), polyurethane, polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), or medical-grade polycarbonate. etc. In an embodiment, the sheath coupler 250 is made of acrylonitrile butadiene styrene (ABS). The dimensions of the sheath coupler 250 may be selected based on the device 100, user handling preferences, and compatibility with surrounding components. The length of the sheath coupler 250 may range from 51 mm to 105 mm, and the width may range from 52 mm to 21 mm. The height of the sheath coupler 250 may range between 21 mm and 58 mm. In an embodiment, the length, width and height of the sheath coupler 250 are 83 mm, 37 mm, and 28mm, respectively.
[0042] In an embodiment, the sheath coupler 250 includes a first cavity 252 disposed toward the proximal end 250a. The first cavity 252 extends in a distal direction along at least a partial axial length of the sheath coupler 250. The first cavity 252 is configured to receive a corresponding structure of the handle 500. The first cavity 252 defines a housing region for alignment and engagement of the sheath coupler 250 with the handle 500. The first cavity 252 may have a circular, rectangular, or polygonal cross-sectional profile, depending on the design of the handle 500. In an embodiment, the first cavity 252 has a rectangular shape with four walls. The dimension of the first cavity 252 depends on the corresponding coupling structure of the handle 500. The depth of the first cavity 252 (i.e., its axial length from its proximal end to its distal end) may range from 14 mm to 05 mm. In an example implementation, the depth of the first cavity 252 is 08 mm.
[0043] The first cavity 252 includes a plurality of latches 254 configured to engage with corresponding locking features of the handle 500, thereby enabling secure attachment between the sheath coupler 250 and the handle 500. The engagement between the latches 254 and the handle 500 may be achieved through various mechanisms including, but not limited to, snap-fit, twist-lock, or interference-fit, depending on the structural configuration of the handle. In one embodiment, the latches 254 are positioned opposite each other along lateral walls of the first cavity 252 to ensure balanced retention of the handle 500. Optionally, an edge of the latches 254 may be chamfered to reduce stress concentrations and allow smoother coupling. In an embodiment, each latch 254 includes a head 254a and an elongated body 254b, with the head 254a positioned toward the proximal end 250a of the sheath coupler 250. The head 254a is laterally offset or angled with respect to the elongated body 254b, allowing the head 254a to seat within a corresponding locking feature in the handle 500 during assembly.
[0044] In an embodiment, the latches 254 are uniformly distributed on all four walls of the first cavity 252, spaced at 90° intervals, to provide a balanced and secure engagement with the handle 500. Each latch 254 may have a geometric profile such as trapezoidal, triangular, U-shaped, V-shaped, rectangular, etc. In an example embodiment, the latch 254 has a trapezoidal cross-section with a width ranging from 5 mm to 15 mm, a length ranging from 7 mm to 20 mm. In an embodiment, the width and the length of the latch 254 are 11 mm and 10 mm, respectively. The thickness of the latch 254 may range from 01 mm to 08mm. In an embodiment, the thickness of the latch 254 is 02 mm.
[0045] Optionally, the sheath coupler 250 includes a plurality of first slots 256 formed adjacent to the latches 254 on the outer surface of the first cavity 252. The first slots 256 extend in a vertical direction, perpendicular to a longitudinal axis along a partial length of lateral walls (or side walls) of the sheath coupler 250. The first slots 256 enable the side wall of the first cavity 252 to flex during latch engagement, thereby enhancing coupling reliability and reducing insertion force. Each first slot 256 may have a rectangular, semi-elliptical, or v-notch cross-section and may range in length from 5 mm to 18 mm, and have a width ranging from 01 mm to 12 mm, depending on the wall thickness of the sheath coupler 250. In an embodiment, the length and the width of the first slots 256 are 8 mm and 3 mm, respectively.
[0046] Additionally, or optionally, the sheath coupler 250 includes a plurality of ribs 258 along an outer surface of a top end of the sheath coupler 250. The plurality of ribs 258 extends longitudinally between the proximal end 250a and the distal end 250b and is spaced apart peripherally around the sheath coupler 250 and may be symmetrically arranged to provide a balanced structure. Each rib 258 may have a concave, serrated, ribbed, or textured geometry to enhance tactile grip. In certain embodiments, the ribs 258 are configured as semi-circular depressions or shallow rectangular grooves. The ribs 258 facilitate improved manual handling of the device 100, especially in conditions where the device 100 must be operated with gloved hands or in a fluid-rich surgical field. The structural contours of the ribs 258 enhance frictional engagement, thereby allowing the operator to securely couple or decouple the sheath coupler 250 from the handle 500 with minimal risk of slippage.
[0047] The sheath coupler 250 includes a second cavity 260 disposed on a bottom surface of the sheath coupler 250. The second cavity 260 is adapted to accommodate a first support roller 360a (shown in Fig. 2A2). In other words, the first support roller 360a is mounted in the second cavity 260 and configured to direct the guidewire 350. In an embodiment, the second cavity 260 has a curved recessed profile, including a concave inner contour that extends upward and inward toward the top side of the sheath coupler 250. In an embodiment, the second cavity 260 profile may be semicircular, U-shaped, or elliptically curved to optimize contact and clearance with the first support roller 360a.
[0048] In an embodiment, the second cavity 260 includes a plurality of projections 262, each strategically positioned laterally within the second cavity 260 to secure and stabilize the first support roller 360a. The projections 262 may be rectangular posts, semi-circular stubs, or flexible retaining arms, depending on the mounting configuration of the first support rollers 360a. In an embodiment, the projections 262 are in the form of axially extending cylindrical protrusion. Each projection 262 serves as a mounting point or retention barrier, ensuring that the first support roller 360a maintains proper axial alignment. The coupling between the projection 262 and the first support roller 360a allows rotation of the first support roller 360a in a predefined direction.
[0049] As depicted in Fig. 2A3, the sheath coupler 250 includes a second lumen 250d that extends from the first cavity 252 in a distal direction along a portion of the length of the sheath coupler 250. The sheath coupler 250 includes a first lumen 250c extending from the distal end 250b of the sheath coupler 250 to the second cavity 260 of the sheath coupler 250. The first lumen 250c is disposed adjacent to or positioned parallel with the second lumen 250d. In an embodiment, the first lumen 250c is axially aligned with a channel 220c of the sheath 220. The sheath coupler 250 includes a third cavity 264 positioned toward the distal end 250b, which provides an interface for the second lumen 250d and the first lumen 250c. In an embodiment, the second lumen 250d extends between the first cavity 252 and the third cavity 264.
[0050] The diameter of the second lumen 250d may range from 3.5 mm to 21 mm. In an embodiment, the diameter of the second lumen 250d is 5.2 mm. The diameter of the first lumen 250c may range from 06 mm to 18 mm. In an embodiment, the diameter of the first lumen 250c is 10 mm. The length of the second lumen 250d and the first lumen 250c may range from 03 mm to 08 mm and from 05 mm to 15 mm, respectively. In an embodiment, the length of the second lumen 250d is 4.95 mm and the length of the first lumen 250c is 10 mm.
[0051] Fig. 2B depicts a perspective view of the sheath 220 of the cutting assembly 110, according to an embodiment of the present disclosure. The sheath 220 is in the form of an elongate shaft and provides an extended reach to access implanted leads situated deep within the cardiovascular system. The sheath 220 is configured to guide and support the cutting element 200 during insertion and operation. Additionally, the sheath 220 offers structural stability and acts as a protective conduit for internal components, minimizing the potential for vascular trauma. The sheath 220 facilitates minimally invasive access to anatomically challenging regions, enhancing clinical utility in complex cases.
[0052] In an embodiment, the sheath 220 includes the proximal end 220a coupled to the sheath coupler 250 and a distal end 220b coupled to the cutting element 200. The sheath 220 extends longitudinally between the proximal end 220a to the distal end 220b, defining an axial length. The proximal portion 200c of the cutting element 200 is coupled to the distal end 220b of the sheath 220. In an embodiment, a portion of the sheath 220 at the proximal end 220a is disposed within the first lumen 250c of the sheath coupler 250 and is operatively coupled to the drive assembly 130 of the device 100. Upon receiving a first rotational actuation from the drive assembly 130, the sheath 220 rotates in a defined direction. The sheath 220 transfers the first rotational actuation to the cutting element 200, allowing both components to rotate synchronously, clockwise or counterclockwise, depending on procedural needs or operator preference.
[0053] In an embodiment, the distal end 220b of the sheath 220 and the cutting element 200 are coupled using, for example, without limitation, snap-fit connections, adhesive bonding, threaded interfaces, or other mechanical engagement features. In an embodiment, the distal end 220b includes a recess 222 or mating structure that allows the sheath 220 and the cutting element 200 to be securely engaged via a complementary interface (shown in Fig. 2D). The sheath 220 is formed as an elongated tubular member, typically cylindrical, although the sheath 220 may have alternative geometries such as oval or tapered profiles based on procedural requirements. The sheath 220 is configured to be flexible. In an embodiment, the sheath 220 incorporates a braided reinforcement that enhances strength and durability, while maintaining sufficient flexibility to facilitate navigation through tortuous anatomical pathways. The design ensures adequate torsional rigidity to withstand rotational forces during use.
[0054] In an embodiment, the proximal end 220a of the sheath 220 includes an annular ridge 224. The annular ridge 224 is provided with a sloped profile configured to facilitate a smooth flow of biological fluids and to aid in the advancement of the guidewire 350, thereby preventing the guidewire 350 from catching or getting stuck at the proximal end 220a of the sheath 220. The slope of the annular ridge 224 may range from 5° to 45° with respect to a longitudinal axis of the sheath 220. In an embodiment, the slope of the annular ridge 224 is about 11°.
[0055] In an embodiment, the sheath 220 includes the channel 220c that extends internally from the proximal end 220a to the distal end 220b and is configured to provide a passage for a fluid. The dimensions of the sheath 220 are chosen based upon the clinical requirements. The diameter of the channel 220c may range from 05 mm to 15 mm. In an embodiment, the diameter of channel 220c is 05 mm. The length and diameter of the sheath 220 may vary from 44 mm to 80 mm and 4.5 mm to 15.5mm, respectively. In an embodiment, the length and diameter of the sheath 220 is 45 mm and 4.6mm, respectively. The sheath 220 may be made of biocompatible materials including, but not limited to, polyurethane, nylon, PTFE, etc., selected to ensure flexibility, durability, and compatibility with vascular anatomy.
[0056] Fig. 2C depicts a perspective view of the cutting element 200, according to an embodiment of the present disclosure. The cutting element 200 is disposed at the distal end 220b of the sheath 220. The cutting element 200 is configured to dissect the calcified or fibrotic tissue surrounding the implanted lead. In an embodiment, the cutting element 200 has an elongated tubular configuration having a lumen 200e. The lumen 200e extends from a proximal end 200a to a distal end 200b of the cutting element 200. The lumen 200e is configured to provide a passage for the guidewire 350 and the biological fluid. The diameter of the lumen 200e may range from 2.5 mm to 6.5 mm. In an embodiment, the diameter of the lumen 200e is 2.6 mm. The cutting element 200 may be made of a biocompatible material, including, without limitation, stainless steel (e.g., 316L, 440C), cobalt-chromium alloys, titanium alloys, tungsten carbide, or diamond-coated metals. etc. In an embodiment, the cutting element 200 is made up of stainless steel.
[0057] The cutting element 200 includes a proximal portion 200c provided at the proximal end 200a and coupled with a corresponding structure of the sheath 220. The coupling between the proximal portion 200c and the sheath 220 may be achieved using techniques such as snap-fit, threaded engagement, adhesive bonding, or any other mechanical or interference-based method. In an embodiment, the coupling is achieved via a snap-fit mechanism. In one embodiment, the cutting element 200 includes a plurality of protrusions 202 disposed circumferentially on an outer surface of the proximal portion 200c. The protrusions 202 facilitate the coupling of the cutting element 200 to the sheath 220. In an embodiment, each protrusion 202 resides in a corresponding recess 222. In an exemplary embodiment, the protrusions 202 are formed as radially extending cylindrical tabs. In an embodiment, four protrusions 202 are provided, though the number of protrusions 202 may be less than or greater than four. The protrusions 202 are spaced equidistantly around the circumference of the proximal portion 200c to ensure uniform engagement and stable locking within the recess 222. In another embodiment, the proximal portion 200c includes a plurality of threads (not shown) configured to engage with correspondingly threads provided on an inner surface of the sheath 220 towards the distal end 200b of the sheath 220. The length of the proximal portion 200c may range from 04 mm to 12 mm. In an embodiment, the length of the proximal portion 200c is approximately 5 mm.
[0058] The cutting element 200 includes a head 204 disposed at the distal end 200b and a plurality of blades 206 radially disposed within and coupled to the head 204. In an embodiment, the plurality of blades 206 and head 204 may be integrally formed. The head 204 and the blades 206 are manufactured as a single, continuous piece from a tubular member or solid rod, thereby ensuring structural continuity and mechanical strength. Alternatively, the plurality of blades 206 may be coupled to the head 204 using other suitable coupling techniques. In an embodiment, the head 204 is adapted to partially or fully cover the plurality of blades 206. The head 204 prevents unintended damage to adjacent tissue during dissection. The head 204 may have shapes such as circular oval, polygonal, hexagonal, octagonal, elliptical, or semi-spherical etc. In an embodiment, the head 204 has a circular shape. The dimensions of the head 204 may be based on the procedural requirement. The diameter and length of the head 204 may range from 3.2 mm to 8.5 mm and 02 mm to 12.5 mm, respectively. In an embodiment, the diameter and length of the head 204 are 4.6 mm and 2.6 mm, respectively. The head 204 may be made of stainless-steel cobalt-chromium alloys, titanium alloys, tungsten carbide, or diamond-coated metals or other biocompatible materials. In an embodiment, head 204 may be made of stainless steel.
[0059] The blades 206 are circumferentially disposed on an inner surface of the head 204. In an embodiment, the blades 206 are uniformly distributed. The plurality of blades 206 extends in a distal direction and flares outwardly to define an angled profile. The outwardly flared and angled profile of the blades 206 is configured to dissect surrounding fibrotic or calcified tissue, allowing the cutting element to create a channel. The inclined surfaces of the blades 206 create a widening channel that facilitates clearance around the lead, thereby minimizing the risk of unintentional cutting or entrapment. The angle of flaring (φ) of each blade 206 (i.e., the angle made by a longitudinal axis of the blade 206 with a longitudinal axis of the cutting element 200) may range from 11.5° to 45°. In an embodiment, the angle of flaring (φ) of each blade 206 is 12° as depicted in Fig. 2D. In an embodiment, each blade 206 extends partially beyond a distal end of the head 204, with an exposed free length. The exposed length of the blade 206 may range from 0.1 mm to 1.5 mm. In an embodiment, the exposed length of the blade 206 is 0.4 mm. The distance between two opposing blades 206 depends on the angle of flaring (φ) of each blade 206 and may range from 03 mm to 05 mm. In an embodiment, the distance between blades 206 on opposite sides is approximately 3.4 mm. The blades 206 may be made of stainless steel, cobalt-chromium alloys, titanium alloys, tungsten carbide, or diamond-coated metals or other suitable biocompatible materials. In an embodiment, the blades 206 is made of stainless steel. Each blade 206 may have a predefined shape such as, without limitation, rectangular, trapezoidal, triangular, or other geometries optimized for cutting. In an embodiment, each blade 206 has a trapezoidal shape.
[0060] In an embodiment, each blade 206 includes two cutting edges 206a and a top side 206b. Each blade 206 includes the cutting edge 206a that is disposed along each lateral side of the blade 206 and extends away from the lateral side toward an adjacent blade 206, thereby forming a continuous or segmented cutting profile along the surface of the blade 206. The top side 206b defines the outermost surface of the blade 206, contributing to the rotational cutting envelope. The configuration of the lateral cutting edges 206a ensures effective tissue engagement and mechanical efficiency during rotational actuation, while also providing structural continuity between successive peaks and troughs. actuation to the cutting element 200.
[0061] Figs. 3A and 3B depict a perspective view and a sectional view of the extraction assembly 120, respectively, according to an embodiment of the present disclosure. The extraction assembly 120 is configured to extract the implanted lead from a native anatomy of a patient. The extraction assembly 120 is removably coupled to the handle 500. The extraction assembly 120 is operationally coupled to the drive assembly 130. In an embodiment, the extraction assembly 120 includes a chamber 300, a guidewire 350, a second support roller 360b, and a winder 400. The guidewire 350 is wound on the winder 400 and coupled with the implanted lead. In an embodiment, the guidewire 350 includes a proximal end coupled to the winder 400 and a distal end coupled to the implanted lead.
[0062] Figs. 3C depicts sectional views of the chamber 300, according to an embodiment. The chamber 300 is configured to accommodate the winder 400 and the second support roller 360b as depicted in Fig. 3C. The second support roller 360b is configured to direct the guidewire 350 towards the winder 400. The chamber 300 is configured to store at least one biological fluids. The chamber 300 includes a proximal end 300a and a distal end 300b. The chamber 300 has a hollow body defining an internal volume configured to accommodate at least one biological fluid that come along with the guidewire 350 during extraction. The structure of the chamber 300 may be selected based on ergonomic considerations and may include, without limitation, cylindrical, cuboidal, trapezoidal, polygonal, etc. shapes. In an embodiment, the chamber 300 has a trapezoidal shape. The dimensions of the chamber 300 may vary depending on the procedural requirements. In an embodiment, the chamber 300 has a length ranging from 95 mm to 210 mm, a width ranging from 35 mm to 85 mm, and a height ranging from 35 mm to 75 mm. In an embodiment, the length, width and height of the chamber 300 is 172.5, 41, and 65 mm, respectively. The wall thickness of the chamber 300 may range from 0.8 mm to 3.5 mm. In an example, the wall thickness is 1.8 mm. The chamber 300 is fabricated from a biocompatible material including, but are not limited to, polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polypropylene (PP), polyethylene (PE) or a combination thereof. In an embodiment, the chamber 300 is made of polyvinyl chloride (PVC). In an embodiment, the chamber 300 is disposable after a single use.
[0063] The chamber 300 includes a proximal portion 300f that is inserted into a complementary cavity of the handle 500, enabling the chamber 300 to securely couple with the handle 500. In an embodiment, the chamber 300 includes a window 336 that is at least a partially translucent or transparent to allow a visual inspection of collected biological fluids. The chamber 300 enables hygienic operation by collecting expelled biological fluids and simplifying post-procedural cleanup.
[0064] In an embodiment, the chamber 300 includes an opening 300c disposed on an upper wall of the chamber 300. The opening 300c is positioned adjacent to the entry path of the guidewire 350. The opening 300c provides a passage for the guidewire 350 and the biological fluids conveyed through the sheath 220 to flow into the internal volume of the chamber 300 during the lead extraction procedure. The chamber 300 functions as both the biological fluid reservoir and a containment space for the guidewire 350 and the extracted lead. The opening 300c may be shaped as a slot, cut-out, or recessed channel to allow the biological fluid within the internal volume of the chamber 300. The chamber 300 includes a plurality of grooves 302 disposed towards the proximal end 300a of the chamber 300. In an embodiment, the plurality of grooves 302 provided on opposite side walls 300d, 300e of the chamber 300 and configured to slidably engage with corresponding ridges formed within the handle 500 (explained later), thereby enabling insertion and removal of the extraction assembly 120. Such a design facilitates ease of assembly, replacement, and disposal.
[0065] The chamber 300 includes a plurality of apertures 304 disposed on side walls 300d, 300e of the chamber 300 towards the proximal end 300a. Each aperture 304 is configured to receive a locking element of the handle 500 for securing the extraction assembly 120 within the handle 500. In an embodiment, each aperture 304 of the chamber 300 includes a plurality of protrusions 304a. Each protrusion 304a extends inwardly from the outer surface of the chamber 300. Each protrusion 304a is configured to receive and support the winder 400 such that the winder 400 is aligned along its longitudinal axis and permitted to rotate within the chamber 300. Further, each protrusion 304a comprises a lumen 304b, the lumen 304b being configured to receive the corresponding locking element of the handle 500. In this arrangement, opposing protrusions 304a cooperate to hold the winder 400 in place while the lumens 304b allow the locking elements to secure the chamber 300 to the handle 500. This configuration enables the guidewire 350 to be wound onto the winder 400.
[0066] The chamber 300 includes one or more support elements 306 positioned within the top interior and coupled to the side walls 300d, 300e of the chamber 300 as depicted in Fig. 3B. In an embodiment, each support element 306 may be configured as a rod-like structure. The support elements 306 are adapted to secure the second support roller 360b and allow rotation of the second support roller 360b in a predefined direction. In other words, the second support roller 360b is mounted on the support elements 306. The second support roller 360b functions as a directional guide for the guidewire 350, ensuring smooth and controlled routing from the first support roller 360a of the sheath coupler 250 to the second support roller 360b of the chamber 300. The second support roller 360b minimizes the risk of kinking, twisting, or frictional drag by guiding the guidewire 350 through a stable path, thereby maintaining the structural integrity and operational efficiency of the device 100.
[0067] In an embodiment, the extraction assembly 120 includes the guidewire 350. The guidewire 350 may include an elongated flexible shaft having a proximal end and a distal end. The dimensions of the guidewire 350 are chosen based upon procedural requirements. In an embodiment, the guidewire 350 has a predefined diameter and length ranging from 0.02 mm to 0.5 mm and from 800 to 1200 mm, respectively. In an embodiment, the diameter and length of guidewire 350 is 0.03 mm and 1150 mm, respectively. The guidewire 350 may be formed from biocompatible materials such as stainless steel, nitinol, polymer, etc. The distal end of the guidewire 350 may include a tapered or atraumatic tip to facilitate atraumatic navigation through vascular pathways. The guidewire 350 may be coated with PTFE, hydrophilic polymers, silicone, etc., to enhance lubricity and minimize friction during insertion and extraction. In an embodiment, the guidewire 350 is coated with hydrophilic polymers. Depending on clinical requirements, the guidewire 350 may be configured as a standard workhorse guidewire, a stiff guidewire for crossing fibrotic tissue, or a guidewire designed for tortuous anatomy. In an embodiment, the guidewire is a stiff supportive guidewire to facilitate advancement and stabilization of the extraction sheath. The distal end of the guidewire is coupled to a proximal end of the implanted lead during extraction. The coupling ensures that subsequent actuation of the extraction will transfer tensile force directly to the implanted lead, enabling controlled retraction while minimizing the risk of slippage or partial detachment. The guidewire 350 may be coupled to the implant lead using knots, clamps etc. In an embodiment, the guidewire 350 is manually knotted with the implant lead.
[0068] In an embodiment, the guidewire 350 is routed along a defined path and is initially guided by the first support roller 360a provided in the sheath coupler 250 and the second support roller 360b provided in the chamber 300 after entering the opening 300c of chamber 300, ensuring proper axial alignment while avoiding impingement with the walls of the second cavity 260 or interference with the first support roller 360a. From there, the guidewire 350 enters the channel 220c of the sheath 220 and continues through the lumen 200e of the cutting element 200. The guidewire 350 extends distally beyond the cutting element 200 and is configured for coupling with the implanted lead, such as, an implanted lead 10, during the extraction process. As shown in Fig. 4, the coupling is achieved using a locking wire 20, which acts as a suture loop or locking stylet. In one embodiment, the guidewire 350 is in contact with the implanted lead, such as an implanted lead 10, and the locking wire 20 is tied or looped around to create a secure knot, thereby firmly locking the guidewire 350 and the implanted lead 10 together. This configuration ensures that during the subsequent winding of the winder 400, the implanted lead 10 is drawn proximally along with the guidewire 350 in a controlled and stable manner. The coupling facilitates smooth and precise translation of the guidewire 350, free from unwanted contact with surrounding anatomical structures. By employing the locking wire 20 as an intermediary coupling element, the attachment between the guidewire 350 and the implanted lead 10 remains strong and resistant to slippage, ensuring reliable retrieval of the lead during the extraction stage. It should be understood that the implanted lead 10 is merely exemplary and the implanted lead may have any other structure without deviating from the scope of the present disclosure.
[0069] The first support roller 360a and the second support roller 360b, although individually referenced, are collectively referred to as support roller 360 within the scope of the present disclosure. An exemplary support roller 360 is depicted in Fig. 5. The first support roller 360a and second support roller 360b are considered functionally and structurally similar for the purposes of description, and any reference to the support roller 360 herein is intended to encompass both the first and second support rollers 360a and 360b unless otherwise specified.
[0070] In an embodiment, the support roller 360 is a rotatable elongated cylindrical body with a central roller lumen 362. The support roller 360 supports and guides the guidewire 350 along a defined path during the extraction procedure. In an embodiment, the central roller lumen 362 of the first support roller 360a is configured to receive the projections 262 of the sheath coupler 250, while the central roller lumen 362 of the second support roller 360b is configured to receive the support elements 306 located within the chamber 300. The diameter of the central roller lumen 362 may be selected based on the outer diameter of the projection 262 or support element 306, ensuring a stable rotatable fit of the support roller 360. The diameter of each support roller 360 may range between 03 mm and 15 mm. In an embodiment, the diameter of the first support roller 360a and second support roller 360b is 05 mm and 11 mm, respectively. The support rollers 360 may be automatically or manually operated. In an embodiment, the support rollers 360 are idler rollers that are freely moveable and operated by guidewire.
[0071] The outer surface of the support roller 360 may be smooth, grooved, or contoured to facilitate controlled contact with the guidewire 350, ensuring low-friction guidance. In an embodiment, at least one end of the support roller 360 is provided with a tapered portion of gradually increasing diameter. The tapered portion assists in centering the guidewire 350 onto the roller surface, thereby preventing slippage, reducing frictional wear, and maintaining consistent guidance of the guidewire 350 along its path. The geometry and surface finish of the support roller 360 may be optimized to minimize wear, prevent kinking, and maintain consistent tension during the coiling or extraction process. The support roller 360 may be formed from biocompatible, low-friction materials, such as polyvinyl chloride (PVC), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polypropylene (PP) or similar polymers suited for disposable medical components. In an embodiment, the support roller 360 is made of ABS.
[0072] Fig. 6 depicts a perspective view of the winder 400, according to an embodiment of the present disclosure. The winder 400 is configured to facilitate the extraction of the implanted lead as the winder 400 winds and receive the guidewire 350 that exits from the sheath 220 during the extraction of the implanted lead. The winder 400 has a cylindrical body extending between a first end 400a and a second end 400b, and is rotatably mounted within the chamber 300. The winder 400 includes a cavity 404 at each of the first end 400a and second end 400b of the winder 400. The cavities 404 extend towards each other for a partial length of the cylindrical body of the winder 400. Each cavity 404 is configured to receive a respective protrusion 304a of the chamber 300 to secure the winder 400 within the chamber 300. The protrusions 304a are configured to hold the winder 400 in position while allowing free rotation about a longitudinal axis of the winder 400. The dimension of each cavity 404 corresponds to dimension of the protrusion 304a. This configuration enables the winder 400 to remain anchored within the chamber 300 during rotation, ensuring controlled and confined wounding of the guidewire 350 within the internal volume of the chamber 300.
[0073] The winder 400 includes a central lumen 402 that extends between the cavities 404 and is configured to receive the locking element of the handle 500. The central lumen 402 is axially aligned with the lumen 304b of each protrusion 304a, wherein the lumen 304b of the protrusions 304a and the central lumen 402 receive a locking pin coupled to the drive assembly 130. The central lumen 402 may have various predefined cross-sectional shapes, including but not limited to circular, rectangular, triangular, polygonal, elliptical, etc. In an embodiment, the central lumen 402 has a triangular cross-section. The triangular cross-section provides increased surface engagement with the locking element, thereby reducing slippage and enhancing torque transfer.
[0074] The winder 400 is disposable and intended for single use. The winder 400 may have a predefined length ranging between 05 mm and 35 mm. In an embodiment, the length of the winder 400 is 31 mm. The winder 400 may have a uniform or non-uniform diameter. In an embodiment, the winder 400 is flared towards the first end 400a and the second end 400b. In an alternative embodiment, the winder 400 has a uniform diameter ranging from 10 mm and 28 mm. The winder 400 is fabricated from biocompatible, including, but not limited to polyvinyl chloride (PVC), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polypropylene (PP) etc. In an embodiment, the winder 400 is made of ABS.
[0075] Fig. 7A and Fig. 7B depict a perspective view and an exploded view of the handle 500 of the device 100, respectively, according to an embodiment of the present disclosure. The handle 500 is positioned at the proximal end 100a of the device 100 and is configured to house various components of the drive assembly 130. The handle 500 is removably coupled to the cutting assembly 110 and the extraction assembly 120. The handle 500 has an ergonomic shape that enables an operator to hold and control the device 100 with ease and precision during the dissection and extraction. In an embodiment, the handle 500 includes a housing 501, a pair of covers 510, and a locking pin 516. The housing 501 includes a top wall 501a, a bottom wall 501b, a front wall 501c, a rear wall 501d, and a pair of side walls 501e, which collectively define an internal cavity for accommodating components of the drive assembly 130. The pair of side walls 501e are located opposite to each other. The housing 501 includes a holding portion 505 towards the rear wall 501d that enables the operator to hold and control the device 100 with ease and precision during the dissection and extraction.
[0076] In an embodiment, the handle 500 includes a coupling portion 502 disposed toward a distal end of the handle 500, adjacent to a top wall 501a. The coupling portion 502 is configured to be removably disposed within the first cavity 252 of the sheath coupler 250, thereby facilitating mechanical engagement therebetween. The shape and dimensions of the coupling portion 502 are complementary to the shape and dimensions of the first cavity 252 to ensure a secure fit, stable axial alignment. The coupling portion 502 includes a distal surface 502a disposed towards a distal end of the coupling portion 502. The distal surface 502a includes a plurality of slots 502b and an opening 502c. Each of the plurality of slots 502b is configured to receive the corresponding latch 254 of the first cavity 252 to secure the sheath coupler 250 with the handle 500. The opening 502c is configured to allow operational coupling between the drive assembly 130 and the cutting assembly 110. The coupling portion 502 includes a plurality of openings 502c disposed therewithin and configured to retain the corresponding latch 254 of the sheath coupler 250, thereby enabling snap-fit engagement between the sheath coupler 250 and the handle 500. The slots 502b are dimensioned to receive and align with the elongated body of the latch 254, providing additional lateral stability. The housing 501 of the handle 500 includes a cavity 503 disposed on the front wall 501c and configured to receive the proximal portion 300f of the chamber 300.
[0077] In an embodiment, the handle 500 includes one or more actuator ports 504 disposed on the top wall 501a and configured to receive a corresponding actuation element of the drive assembly 130 as explained later. The number and arrangement of the actuator ports 504 correspond to the actuators implemented in the drive assembly 130. The actuator port 504 may be designed as a circular hole, an elongated slot, or any other configuration compatible with the actuator structure. In an embodiment, the handle 500 includes two actuator ports 504 symmetrically placed on the top wall 501a of the housing 501. The housing 501 includes a plurality of ridges 506 provided within the cavity 503 and disposed on the inner surface of the side walls 501e of the housing 501. Each of the plurality of ridges 506 is configured to slidably engage with the corresponding groove 302. The ridge-groove configuration facilitates linear insertion and removable of the chamber 300 into the handle 500 while maintaining axial alignment.
[0078] In an embodiment, each side wall 501e includes a depression 507 that extends inwards for a partial length of side wall 501e. The depression 507 is configured to receive the respective cover 510. The depression 507 of the handle 500 includes a handle lumen 508 with a protrusion 508a extending outward from the respective side wall 501e. The handle lumen 508 is aligned with the corresponding lumen 304b of protrusion 304a and is configured to receive the locking pin 516 to secure the extraction assembly 120.
[0079] In an embodiment, the plurality of covers 510 includes a first cover 510a and a second cover 510b. In an embodiment, the first cover 510a and the second cover 510b are positioned on the respective depression 507 of the housing 501. The covers 510 are configured to be mounted onto the protrusion 508a and to enclose the respective depression 507. Each cover 510 includes a cover lumen 512a disposed centrally to allow passage for the locking pin 516. The cover lumens 512a align with the handle lumen 508 of the depression 507 of the handle 500. In an embodiment, each of the first cover 510a and the second cover 510b include a gear support 514 positioned axially to the cover lumen 512a. The gear support 514 of the first cover 510a is configured to receive a second gear assembly 650 and the first end 400a of the winder 400, while the gear support 514 of the second cover 510b is configured to receive the second end 400b of the winder 400. The gear support 514 includes a gear support lumen 514a configured to receive the locking pin 516. The shape and dimension of gear support lumen 514a corresponds to that of the locking pin 516. In an embodiment, the gear support lumen 514a has a triangular cross-sectional profile to allow precise torque transmission and to prevent slippage during rotation. In an embodiment, each cover 510 is configured to rotate in a predefined direction, in response to the rotation of the drive assembly 130.
[0080] The locking pin 516 is configured to couple the extraction assembly 120 with the handle 500 and is operationally coupled to the drive assembly 130. In an embodiment, the locking pin 516 includes a head 516a and a shaft 516b. The shaft 516b extends axially through the cover lumen 512a, the gear support lumen 514a, the handle lumen 508 and the central lumen 402 of the winder 400. The head 516a engages with the corresponding cover 510 to keep the locking pin 516 in place. In an embodiment, a first end of the shaft 516b is coupled to the drive assembly 130 to receive rotational actuation and a second end of the shaft 516b is coupled to the head 516a. The head 516a is dimensioned to be seated within the cover lumen 512a of the cover 510. In an embodiment, the shaft 516b has a triangular cross-section to match the corresponding mating structures and ensure non-slip engagement during rotational actuation. The handle lumen 508 is positioned to align with the apertures 304 of the chamber 300 when the extraction assembly 120 is mounted within the cavity 503 of the handle 500. This alignment enables the shaft 516b to pass through the handle lumen 508 and into the central lumen 402 of the winder 400, thereby coupling and securing the extraction assembly 120 with the handle 500 while permitting rotation of the winder 400.
[0081] Fig. 8 illustrates the drive assembly 130, according to an embodiment of the present disclosure. The drive assembly 130 is operationally coupled to the cutting assembly 110 and the extraction assembly 120. The drive assembly 130 is disposed within the sheath coupler 250 and the handle 500 and is configured to generate rotational actuation required for the operation of both the cutting assembly 110 and the extraction assembly 120. In an embodiment, the drive assembly 130 is configured to selectively provide a first rotational actuation to the sheath 220 to rotate the cutting element 200 and a second rotational actuation to the winder 400 to wind and extract the implanted lead by coiling the guidewire 350.
[0082] In an embodiment, the drive assembly 130 includes at least one motor 600a, 600b, a processing unit 620, a first gear assembly 640, a second gear assembly 650, at least one actuators 660, and a power source 680. The least one motor 600a, 600b is configured to selectively provide. In an embodiment, as depicted in Fig. 8, the at least one motor 600a, 600b includes a first motor 600a operably coupled to the first gear assembly 640 and a second motor 600b operably coupled to the second gear assembly 650, thus forming a dual-driver configuration. The first motor 600a provides the first rotational actuation to the sheath 220 via the first gear assembly 640, while the second motor 600b provides the second rotational actuation to the winder 400 via the second gear assembly 650. Each motor 600a, 600b includes a rotating shaft that directly transmits torque to the corresponding gear assembly, thereby enabling independent and precise control of the cutting assembly 110 and the extraction assembly 120.
[0083] In another embodiment, the drive assembly 130 includes a single motor operably coupled to both the first gear assembly 640 and the second gear assembly 650, thus forming a single-driver configuration. In this case, the motor 600 is configured to selectively provide the first and second rotational actuations to the sheath 220 and the winder 400, respectively. In this embodiment, the processing unit 620 coordinates switching between the two rotational actuations to ensure controlled transition from the cutting phase to the extraction phase. In an embodiment, the first motor 600a and the second motor 600b includes an electric motor, such as an AC motor, or DC motor. The first motor 600a and the second motor 600b are electrically coupled to power source 680 via the processing unit 620. In an embodiment, each of the first motor 600a and the second motor 600b includes a DC motor.
[0084] Optionally, or additionally, the first motor 600a and the second motor 600b are secured within the handle 500 using a clamp and a plurality of fasteners. The clamp is configured to fix the positional alignment of the motor 600 within the handle 500 and to prevent displacement of the motor 600. The clamp and fasteners may comprise conventional retention structures, such as threaded screws, locking tabs, or equivalent elements, dimensioned and arranged to ensure stable mounting of the motor 600 during operation.
[0085] The first motor 600a is disposed in the handle 500. The first gear assembly 640 is disposed within the sheath coupler 250 and coupled to the at least one motor 600a, 600b and the sheath 220. In other words, the first gear assembly 640 is operatively coupled to the sheath 220 and the at least one motor 600a, 600b, the first gear assembly 640 configured to transmit the first rotational actuation to the sheath 220. In an embodiment, first gear assembly 640 is coupled to the first motor 600a. The first gear assembly 640 is configured to transmit rotational movement of the first motor 600a to the sheath 220. The rotational movement of the cutting element 200 causes the blade 206 to dissect the tissue surrounding the implanted lead. In an embodiment, the first gear assembly 640 includes a drive shaft 646, a first drive gear 642, a first driven gear 644, and a connector 648. The drive shaft 646 is disposed within the second lumen 250d of the sheath coupler 250 as depicted in Fig. 9. In an embodiment, the drive shaft 646 is concentrically disposed within the second lumen 250d of the sheath coupler 250, facilitating smooth and stable rotational transmission from the first motor 600a to the first gear assembly 640. The proximal end of the drive shaft 646 is operably coupled to the first motor 600a and a distal end. The proximal end of the drive shaft 646 is coupled to the distal end of the drive shaft 646 of the first motor 600a. The first drive gear 642 is rotatably coupled to the distal end of the drive shaft 646. The first drive gear 642 is mounted at the distal end of the drive shaft 646 and is disposed within the third cavity 264. The drive shaft 646 is configured to rotate upon receipt of the first rotational actuation. In an embodiment, the proximal end of the drive shaft 646 is coupled to the first motor 600a through the coupling element 602.
[0086] In an embodiment, the coupling element 602 couples the drive shaft 646 of the first motor 600a and the drive shaft 646 of the first gear assembly 640. In an embodiment, the coupling element 602 is disposed within the coupling portion 502 of the handle 500 and is removably coupled to the drive shaft 646. In an embodiment, the coupling element 602 includes a proximal end coupled to the rotating shaft of the first motor 600a and a distal end coupled to the drive shaft 646. The engagement may be achieved through one or more coupling techniques, including, without limitation, snap-fit locking, press-fit, adhesive bonding, UV-curable bonding, or the use of mechanical fasteners. In an embodiment, the coupling element 602 has a cylindrical geometry; however, other geometries, such as cuboidal, polygonal, or other prismatic forms, may also be used depending on torque requirements and required design. While the depicted embodiments illustrate the coupling of the first motor 600a and the drive shaft 646 of the first gear assembly 640 via the coupling element 602, a person skilled in the art will appreciate that numerous variations can be implemented while maintaining the rotatable coupling between the first motor 600a and the first gear assembly 640. These variations are within the scope of the teachings of the present disclosure.
[0087] The first drive gear 642 includes a plurality of first teeth circumferentially arranged along its periphery. The first teeth may have a straight, spiral, or helical profile depending on torque transmission and directional requirements. In an embodiment, the first teeth have flat profile. The first driven gear 644 is coupled to the sheath 220 and rotatably coupled to the first drive gear 642. The first driven gear 644 is disposed adjacent to the proximal end 220a of the sheath 220, such that the proximal end of the sheath 220 projects proximally beyond the first driven gear 644. The first driven gear 644 is coupled to the first drive gear 642. The first driven gear 644 includes a plurality of second teeth that are configured to mesh with the first teeth of the first drive gear 642.
[0088] The connector 648 is disposed adjacent to the first driven gear 644 and is configured to couple the sheath 220 with the sheath coupler 250 and allow the rotation of the sheath 220. In an embodiment, the connector 648 is mounted on the sheath 220. In an embodiment, the connector 648 provides a secure and removable coupling between the first driven gear 644 and the proximal end of the sheath 220. The connector 648 may include keyways, splines, locking tabs, or other engagement features to ensure mechanical alignment and stable torque transfer from the first gear assembly 640 to the sheath 220 and, subsequently, to the cutting element 200.
[0089] The second gear assembly 650 is housed within the handle 500 and is operably coupled to the winder 400 and at least one motor 600a, 600b. In an embodiment, the second gear assembly 650 is coupled to the second motor 600b. The second gear assembly 650 is configured to transmit the second rotational actuation to the winder 400. Upon receiving the second rotational actuation, the second gear assembly 650 is configured to transfer the rotational movement of the second motor 600b to the winder 400. In an embodiment, the second gear assembly 650 includes a second drive gear 652 and a second driven gear 654. The second drive gear 652 is operably coupled to the second motor 600b. In an embodiment, the second driver gear 652 is mounted of the drive shaft of the second motor 600b and is configured to rotate upon receiving the second rotational actuation.
[0090] The second driven gear 654 is disposed within the depression 507 of one of the side walls 501e of the housing 501. In an embodiment, the second driven gear 654 is concentrically mounted on the gear support 514 and operably coupled to the second drive gear 652. The second driven gear 154 is rotatably coupled to the second drive gear 652 and the locking pin 516. The second driven gear 154 is configured to transfer the rotational movement of the second drive gear 652 to the locking pin 516 coupled to the winder 400, to rotate the winder 400. The second driven gear 654 is configured to rotate the cover 510 in response to the rotation of the second drive gear 652. The second drive gear 652 includes a plurality of third teeth circumferentially arranged on its periphery, while the second driven gear 654 includes a plurality of fourth teeth that mesh with the third teeth of the second drive gear 652, thereby enabling torque transfer. The second driven gear 654 is configured to transfer the rotational output from the second drive gear 652 to the winder 400 via the locking pin 516 and gear support 514. The second gear assembly 650 may include a planetary gearset configuration or a coaxial geartrain, depending on desired torque reduction and rotational direction. In an embodiment, the second gear assembly 650 is implemented as a planetary gearset.
[0091] In an embodiment, the first gear assembly 640 transmits rotational actuation from the first motor 600a to the sheath 220 for driving the cutting element 200, while the second gear assembly 650 transmits rotational actuation from the second motor 600b to the winder 400 for extracting the guidewire 350. Both the first gear assembly 640 and the second gear assembly 650 are powered by the first motor 600a and the second motor 600b, respectively, and controlled by the processing unit 620. The gear components may be fabricated from high-strength, biocompatible materials such as stainless steel, titanium alloys, or medical-grade polymers.
[0092] Each of the one or more actuators 660 is disposed within the corresponding actuator port 504 of the handle 500 and configured to receive a respective input from the operator to activate the drive assembly 130. The one or more actuators 660 are electrically coupled to the processing unit 620 to enable control over both the first rotational actuation for the cutting assembly 110 and the second rotational actuation for the extraction assembly 120. The one or more actuators 660 may include, but are not limited to, push button, toggle switch, rotary knob, or sliding actuators, etc. In an embodiment, each actuator 660 includes a push button. Each actuator 660 is configured to generate an electrical signal (hereinafter referred to as an activation signal) upon receiving the respective input, e.g., via pressing, toggling, or rotation. The electrical signal is received by the processing unit 620 for initiating the respective rotational actuation of the motor 600. For example, the actuator 660 is configured to generate a first activation signal for initiating the first rotational actuation and a second activation signal for initiating the second rotational actuation.
[0093] In an embodiment, the one or more actuators 660 include a first actuator 660a and a second actuator 660b. The at least one actuator 660 is configured to selectively actuate the first motor 600a and the second motor 600b to provide the first and second rotational actuations, respectively. In other words, the first actuator 660a is configured to initiate the first rotational actuation for activating the cutting assembly 110, and the second actuator 660b is configured to initiate the second rotational actuation for driving the winder 400. Further, the drive assembly 130 includes the first actuator 660a is coupled to the first motor 600a, and the second actuator 660b is coupled to the second motor 600b.
[0094] In an embodiment, upon actuation, the first actuator 660a is configured to generate the first activation signal to actuate the first motor 600a, thereby initiating the first rotational actuation for driving the sheath 220 and cutting element 200 via the first gear assembly 640. Upon actuation, the second actuator 660b is configured to generate the second activation signal to actuate the second motor 600b, thereby initiating the second rotational actuation for driving the winder 400 via the second gear assembly 650. The use of two separate actuators allows the operator to independently and selectively control the cutting and extraction operations.
[0095] In an alternative embodiment, the device 100 includes a single actuator 660 configured to deliver differentiated signals for the first and second rotational actuations. In one embodiment, sequential activation is employed, a first press of the actuator 660 may initiate the first rotational actuation for rotating the cutting element 200, while a subsequent press, i.e., a second press, triggers the second rotational actuation for rotating the winder 400. In another embodiment, differentiated press durations are employed, e.g., pressing the actuator 660 for a first duration (e.g., about 2 seconds) initiates the first rotational actuation, while pressing the actuator 660 for a second duration, longer than the first duration (e.g., about 5 seconds), initiates the second rotational actuation. The processing unit 620 interprets the received signals and accordingly actuates the respective motor 600a or 600b, which in turn drives the corresponding gear assembly 640 or 650.
[0096] In an embodiment, the processing unit 620 is coupled to the first motor 600a, the second motor 600b, the actuators 660, and the power source 680. The processing unit 620 is configured to execute predefined instructions for actuating the motor 600 upon receiving the input from the actuator 660. The processing unit 620 regulates various operational parameters of the motor 600 including, but not limited to, rotational speed (measured in revolutions per minute or RPM), torque, and rotational direction. The RPM may be selected based on procedural requirements, such as the anatomical location and the degree of tissue adhesion, particularly in cases involving calcified or fibrotic tissue surrounding the implanted lead. Controlled regulation of rotational speed and torque facilitates safe and effective dissection during the cutting phase and precise coiling during the extraction phase, thereby improving procedural accuracy and patient safety.
[0097] In an embodiment, the processing unit 620 is configured to actuate the first motor 600a and the second motor 600b based on the first and second activation signals received from the actuator 660. The first rotational actuation corresponds to initiating the cutting operation, wherein the processing unit 620 directs power and control signals to the first motor 600a to drive the first gear assembly 640 and rotate the cutting element 200. The second rotational actuation corresponds to initiating the extraction operation, wherein the processing unit 620 directs power and control signals to the second motor 600b to drive the second gear assembly 650 and rotate the winder 400. In an embodiment, the processing unit 620 drives the respective motor 600a, 600b based on the received activation signal. In an alternative embodiment with a single motor, the processing unit 620 controls a controllable transmission assembly that selectively couples the rotational output of the single motor to either the first gear assembly 640 for cutting or the second gear assembly 650 for extraction. The transmission assembly may include a gear, pulley, belt, coupling, or shaft configured to transfer rotational motion from the motor to the cutting assembly 110 and the extraction assembly 120 of the device 100.
[0098] The processing unit 620 may include, but is not limited to, a microcontroller, a microprocessor, a graphical processing unit (GPU), an application-specific integrated circuit (ASIC), or other electronic circuitry capable of interpreting and executing machine-readable instructions. These instructions may be pre-programmed or dynamically updated and may reside in an embedded memory. The processing unit 620 may also support firmware upgrades or user-defined parameter adjustments via an external programming interface or dedicated communication port. This allows the operator or service personnel to customize device performance based on specific clinical needs or operational protocols. In an example implementation, the device 100 includes a printed circuit board (PCB) having the processing unit 620 provided thereon. The processing unit 620 is disposed within the handle 500.
[0099] In an embodiment, the device 100 includes a motor driver circuit 630 communicatively coupled (i.e., capable of exchanging data) to the processing unit 620. In an embodiment, the motor driver circuit 630 is implemented in the form of an integrated circuit. The motor driver circuit 630 may be located on the same PCB as that of the processing unit 620 or may be provided on a separate PCB. The motor driver circuit 630 is electrically coupled to the at least one driver, e.g., the first motor 600a and the second motor 600b. The motor driver circuit 630 is configured to receive at least one control signal from the processing unit 620 and send a motor drive signal to the at least one driver based upon the at least one control signal. In other words, the motor driver circuit 630 acts as an intermediary between the processing unit 620 and the motor 600. The motor driver circuit 630 receives low-voltage digital control signals from the processing unit 620 and converts them into appropriate motor drive signals for driving the motor 600. The motor driver circuit 630 enables selective actuation of the first motor 600a or the second motor 600b. The motor driver circuit 630 also facilitates control over the operational parameters of the motor 600, such as rotational speed, direction of rotation, and torque output. For example, when the first actuator 660a is actuated (e.g., pressed), the processing unit 620 generates a first control signal and sends the first control signal to the motor driver circuit 630. Upon receiving the first control signal, the motor drive 630 sends a first drive signal to the first motor 600a to actuate the first motor 600a to initiate the cutting operation. Similarly, when the second actuator 660b is actuated (e.g., pressed), the processing unit 620 generates and sends a second control signal to the motor driver circuit 630. Upon receiving the first control signal, the motor driver circuit 630 sends a second drive signal to the second motor 600b to actuate the second motor 600b to initiate the extraction of the implanted lead. The motor driver circuit 630 adjusts the drive signal (e.g., the first and second drive signals) to change the rotation speed and/or direction of the respective motor under the control of the processing unit 620. For example, the motor driver circuit 630 adjusts a duty cycle of a PWM-based drive signal to change the rotational speed of the respective motor based upon the control signal (e.g., the first and second control signals).
[00100] The power source 680 is electrically coupled to the motor 600 and the processing unit 620 and is configured to supply electrical power to the aforesaid components. The power source 680 may comprise one or more power delivery mechanisms such as internal batteries, external power adapters, or direct connections to alternating current (AC) or direct current (DC) sources, based on procedural requirements. In an embodiment, the power source 680 includes one or more batteries provided within the handle 500. In an embodiment, the batteries are rechargeable.
[00101] In another embodiment, the power source 680 is implemented as an external DC power supply coupled to the motor 600 and the processing unit 620 via a power interface such as a socket, jack, or electrical connector. In yet another embodiment, the power source 680 is an external AC supply connected through a power adapter comprising a rectifier circuit that converts the AC input into a regulated DC output suitable for the motor 600 and the processing unit 620. The choice between internal and external power sources is determined based on the intended use environment, portability, and reusability of the device 100.
[00102] The electrical terminals of the power source 680 are interfaced with the motor 600 and/or the processing unit 620 via direct wiring and/or printed circuit board (PCB) traces. In an embodiment, the power source 680 is also configured to provide power to the actuator 660 and the motor driver circuit 630.
[00103] Figs. 10A to 10D illustrate a method for assembling the device 100 for extraction of the implanted lead, according to an embodiment of the present disclosure. The assembly process proceeds as follows: As shown in Fig. 10A, an unused extraction assembly 120 is prepared, with the guidewire 350 pre-wound around the winder 400. The locking pin 516 is then removed from the handle 500. The extraction assembly 120 is aligned with the housing 501 of the handle 500 such that the grooves 302 on the outer surface of the chamber 300 engage with the corresponding ridges 506 on the inner surface of the housing 501. The extraction assembly 120 is inserted into the housing 501 until the extraction assembly 120 is fully seated, positioning the aperture 304 of the chamber 300 in alignment with the cover lumen 512a. In this position, the locking pin 516 is inserted through the cover lumen 512a of the second cover 510b, then passed through the central lumen 402 of the winder 400 and coupled to the second cover 510b, thereby securely locking the chamber 300 with the handle 500 as depicted in Fig. 10B.
[00104] As shown in Fig. 10B, the distal end of the guidewire 350 is unwound and pulled from the extraction assembly 120 to provide sufficient length for insertion. The distal end of the guidewire 350 is then introduced into the second cavity 260 of the sheath coupler 250 via the first support roller 360a. From this point, the guidewire 350 is passed through the channel 220c of the sheath 220 and continuing along the length of the sheath 220 until the distal end of the guidewire 350 extends outside of the cutting element 200.
[00105] As depicted in Fig. 10C, the unused cutting assembly 110 is prepared for coupling with the handle 500. In this step, the coupling portion 502 of the handle 500 is brought into axial alignment with the first cavity 252 of the sheath coupler 250. The slots 502b of the coupling portion 502 is positioned to receive the latches 254 of the sheath coupler 250. This alignment ensures that, upon advancement, the latches 254 will be guided into the distal surface 502a without obstruction, allowing the coupling portion 502 to be properly seated within the sheath coupler 250.
[00106] As depicted in Fig. 10D, once the coupling portion 502 and the sheath coupler 250 are correctly aligned, the sheath coupler 250 is linearly advanced towards the coupling portion 502 of the handle 500. During this insertion, the latches 254 travel along the distal surface 502a, maintaining their alignment until the sheath coupler 250 reaches a fully seated position. At this point, the latches 254 are biased outward into the corresponding slots 502b in a snap-fit manner, thereby producing both an audible and tactile indication (or feedback) to the user of engagement. This snap-fit coupling mechanically secures the cutting assembly 110 to the handle 500, preventing axial or rotational displacement during operation while still allowing intentional release if required for maintenance or replacement.
[00107] In an embodiment, the handle 500 and certain components of the drive assembly 130, as described herein, are reusable components configured for durability and repeated use across multiple procedures. The cutting assembly 110 and the extraction assembly 120 are structurally arranged to define the fluid path configured to convey at least one biological fluid from the cutting element 200 to the extraction assembly 120 via the sheath 220. The fluid path extends from the distal end 200b of the cutting element 200, through the lumen 200e of the cutting element 200, into the channel 220c of the sheath 220, and further into the first lumen 250c of the sheath coupler 250. The first lumen 250c is fluidically coupled with the opening 300c of the chamber 300 of the extraction assembly 120 via the guidewire 350. Thus, the fluid path extends further from the first lumen 250c of the sheath coupler 250 to the space enclosed by the chamber 300. The chamber 300 is configured to collect biological fluids conveyed along the fluid path.
[00108] The handle 500 is structurally isolated from the fluid path of the sheath coupler 250 and chamber 300. This isolation prevents ingress of biological fluids into the handle 500 and protects the internal drive assembly 130 from contamination, thereby rendering the handle 500 reusable.
[00109] The cutting assembly 110 and the extraction assembly 120 are designed as disposable components that are removably attachable to the handle 500 through structural coupling features, such as the engagement of latches 254 of the sheath coupler 250 with corresponding slots 502b on the handle 500, and the insertion of a locking pin 516 in the extraction assembly 120 and the handle 500. This arrangement enables secure mechanical engagement during use while allowing removal and disposal of the fluid-contacting components after the procedure. The use of sterile, single-use cutting assembly 110 and extraction assembly 120 for each procedure maintains hygiene standards, minimizes cross-contamination risk, and eliminates the need for complex sterilization protocols for these components, while the reusable handle 500 reduces overall procedural cost and medical waste.
[00110] According to the working, the device 100 is configured to perform a sequential cutting and extraction of the implanted lead. In the cutting stage, the operator positions the sheath 220 around the implanted lead at the target site. Once positioned, the operator actuates the first actuator 660a, generating a first activation signal that is transmitted to the processing unit 620. The processing unit 620 activates the first motor 600a, which rotates the first drive shaft 646. The rotational motion of the drive shaft 646 is transferred to the first drive gear 642. The first drive gear 642 meshes with the first driven gear 644 to transfer rotational motion to the sheath 220. As a result, the sheath 220 is rotated about its longitudinal axis, causing the cutting element 200 at its distal end to rotate in unison. The continuous rotation of the cutting element 200 progressively dissects the fibrotic or calcified tissue encasing the implanted lead, enabling separation from surrounding biological structures. During this stage, the operator holds the device 100 by the ergonomic holding portion 505 of the handle 500 allows precise manipulation.
[00111] Following completion of the cutting operation, the operator couples the proximal portion of the implanted lead with the distal end of the guidewire 350, to establish a stable engagement point for extraction. The operator then initiates the extraction stage by actuating the second actuator 660b. Upon activation, the processing unit 620 activates the second motor 600b, which imparts rotational motion to the second drive gear 652. The second drive gear 652 drives the second driven gear 654, which in turn transmits the rotational force to the winder 400. The winder 400 coils the guidewire 350 in a controlled manner. As the guidewire 350 is coupled to the implanted lead, this coiling action generates a consistent tensile force to retract the lead from its anatomical position. During this process, the support rollers 360a and 360b maintain the guidewire 350 in a guided path toward the chamber 300, reducing friction and preventing kinking or structural deformation of the guidewire under high-tension loads.
[00112] As the implanted lead is progressively withdrawn, any associated biological debris or bodily fluid is directed into the chamber 300 for containment and safe disposal. The locking pin 516 maintains mechanical alignment between the winder 400, the second gear assembly 650, and the drive assembly 130, thereby ensuring consistent torque transfer and precise extraction force application. The seamless integration of the cutting stage, executed via the rotation of the sheath 220, and the extraction stage, performed through the coordinated action of the winder 400 and guidewire 350, enables safe, efficient, and minimally invasive removal of the implanted lead while reducing the risk of collateral tissue trauma.
[00113] Fig. 11 illustrates a flowchart of a method 1000 for extracting an implanted lead using the device 100, according to an embodiment of the present disclosure. The method 1000 may be performed under real-time imaging guidance, such as fluoroscopy, echocardiography, or other visualization techniques, to enable precise navigation, accurate positioning, and controlled execution of both cutting and extraction phases. Imaging guidance ensures that the distal end 100b of the device 100 is advanced along a safe anatomical path and that mechanical operations are applied only when the device 100 is correctly aligned with the target site.
[00114] At step 1002, the distal end 100b of the device 100 is surgically introduced into the patient’s chest cavity through an access site such as a venous entry point or surgical incision, depending on the clinical approach. The operator advances the sheath 220 of the device 100 along the guide path toward the anatomical region where the implanted lead is located. During this advancement phase, the sheath 220 remains in a stationary, non-rotating state to prevent accidental contact with surrounding cardiac structures. The advancement continues until the distal end 100b of the device 100 is positioned adjacent to the fibrotic or calcified tissue surrounding the implanted lead.
[00115] At step 1004, once optimal positioning of the device 100 is confirmed under imaging, the operator manually couples the guidewire 350 to the proximal end of the implanted lead.
[00116] At step 1006, the operator actuates the first actuator 660a located on the handle 500. Activation of the first actuator 660a, sends the first activation signal to the processing unit 620. In response, the processing unit 620 causes the cutting element 200 to rotate, as described earlier, to dissect the tissue around the implanted lead.
[00117] At step 1008, upon completion of tissue dissection and once the implanted lead is sufficiently freed from the surrounding tissue, the operator actuates the second actuator 660b positioned on the handle 500. Consequently, the winder 400 rotates to coil the guidewire 350 as explained earlier. As the winder 400 rotates, the guidewire 350 is progressively coiled within the chamber 300, generating a controlled tensile force that retracts the implanted lead. The support rollers 360 guide the lead during this process, ensuring smooth advancement and preventing kinking or uneven loading. The winding continues until the guidewire 350 and implanted lead are fully retracted and securely contained within the chamber 300, thereby preventing contamination of the surgical field and enabling safe removal of the assembly from the patient’s body.
[00118] At step 1010, after the implanted lead and guidewire 350 are fully retracted and securely housed within the chamber 300, the operator withdraws the device 100 from the patient’s body.
[00119] At step 1012, the extraction assembly 120 and cutting assembly 110 are detached from the handle 500, as both are designed as single-use, disposable components. These components, now containing the extracted lead, guidewire, and biological debris, are safely discarded in accordance with medical waste disposal protocols.
[00120] The device offers multiple advantages over a conventional lead extraction device. The device enables safe, efficient, and minimally invasive removal of chronically implanted leads, particularly in cases where fibrotic or calcified tissue encapsulation poses a challenge. The integration of a motor-driven cutting unit facilitates mechanical dissection of adhered tissue without the need for thermal or laser energy, thereby lowering the risk of vascular trauma, bleeding, or perforation. The device reduces reliance on operator strength and manual manipulation, thereby enhancing procedural consistency, safety and minimizing the risk of entanglement, fracture, or operator fatigue. The device has a hybrid configuration with a reusable handle and disposable procedural components, which improves cost efficiency, ensures sterile conditions for each use, and reduces overall medical waste.
[00121] 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 disclosure is/are used. , Claims:We claim:
1. A device (100) for extraction of an implanted lead, the device (100) comprising:
a. a handle (500);
b. a cutting assembly (110) removably coupled to the handle (500), the cutting assembly (110) comprising a sheath (220) and a cutting element (200) coupled to the sheath (220), the cutting assembly (110) configured to dissect fibrotic or calcified tissue surrounding the implanted lead;
c. an extraction assembly (120) removably coupled to the handle (500) and including a guidewire (350) and a winder (400), the guidewire (350) coupled with the implanted lead and the winder (400), the winder (400) configured to facilitate extraction of the implanted lead; and
d. a drive assembly (130) coupled to the cutting assembly (110) and the extraction assembly (120), the drive assembly (130) comprising at least one motor (600a, 600b) configured to selectively provide:
i. a first rotational actuation to the sheath (220) to rotate the cutting element (200); and
ii. a second rotational actuation to the winder (400) to extract the implanted lead by coiling the guidewire (350).
2. The device (100) as claimed in claim 1, wherein the cutting assembly (110) comprises a sheath coupler (250) coupled to a proximal end (220a) of the sheath (220) and removably coupled to the handle (500), the sheath coupler (250) comprises a first cavity (252).
3. The device (100) as claimed in claim 2, wherein the sheath coupler (250) comprises:
a. a second cavity (260) disposed on a bottom surface of the sheath coupler (250);
b. a first support roller (360a) mounted in the second cavity (260), and configured to direct the guidewire (350); and
c. a first lumen (250c) extending from a distal end of the sheath coupler (250) to the second cavity (260) of the sheath coupler (250).
4. The device (100) as claimed in claim 2, wherein the drive assembly (130) comprises a first gear assembly (640) disposed within the sheath coupler (250), the first gear assembly (640) is operatively coupled to the sheath (220) and the at least one motor (600a, 600b), the first gear assembly (640) configured to transmit the first rotational actuation to the sheath (220).
5. The device (100) as claimed in claims 4, wherein the at least one motor (6001, 600b) comprises a first motor (600a) coupled to the first gear assembly (640), wherein the first gear assembly (640) comprises:
a. a drive shaft (646) disposed within a second lumen (250d) of the sheath coupler (250) and including a proximal end operably coupled to the first motor (600a) and a distal end, the drive shaft (646) is configured to rotate upon receipt of the first rotational actuation;
b. a first drive gear (642) rotatably coupled to the distal end of the drive shaft (646); and
c. a first driven gear (644) coupled to the sheath (220) and rotatably coupled to the first drive gear (642).
6. The device (100) as claimed in claim 1, wherein the cutting element (200) comprises:
a. a lumen (200e) extending from a distal end to a proximal end of the cutting element (200) and configured to provide a passage for the guidewire (350) and a biological fluid;
b. a proximal portion (200c) coupled to the distal end (220b) of the sheath (220);
c. a head (204); and
d. a plurality of blades (206) circumferentially disposed on an inner surface of the head (204) and configured to dissect the fibrotic or calcified tissue.
7. The device (100) as claimed in claim 1, wherein the extraction assembly (120) comprises:
a. a chamber (300) configured to store at least one biological fluids; and
b. a second support roller (360b) disposed within the chamber (300) and configured to direct the guidewire (350) towards the winder (400).
8. The device (100) as claimed in claim 1, wherein the handle (500) comprises a cavity (503) configured to receive a proximal portion (300f) of the chamber (300).
9. The device (100) as claimed in claim 8, wherein
a. the chamber (300) comprises:
i. a plurality of protrusions (304a), each protrusion (304a) extending inwards from an outer surface of the chamber (300) and comprising a lumen (304b); and
b. the winder (400) comprises:
i. a cavity (404) disposed at each end (400a, 400b) of the winder (400) and configured to receive the corresponding protrusion (304a); and
ii. a central lumen (402) extending between the cavities (404) and axially aligned with the lumen (304b) of each protrusion (304a), wherein the lumen (304b) of the protrusions (304a) and the central lumen (402) receive a locking pin (516) coupled to the drive assembly (130).
10. The device (100) as claimed in claim 9, wherein the handle (500) comprises a handle lumen 508 aligned with the corresponding lumen (304b) of protrusion (304a) and configured to receive the locking pin (516).
11. The device (100) as claimed in claim 1, wherein the drive assembly (130) comprises a second gear assembly (650) disposed within the handle (500), the second gear assembly (650) is operatively coupled to the winder (400) and the at least one motor (600a, 600b), the second gear assembly (650) configured to transmit the second rotational actuation to the winder (400).
12. The device (100) as claimed in claim 11, wherein at least one motor (600a, 600b) comprises a second motor (600b), wherein the second gear assembly (650) comprises:
a. a second drive gear (652) coupled to the second motor (600b) and configured to rotate in response to receipt of the second rotational actuation; and
b. a second driven gear (654) rotatably coupled to the second drive gear (652) and the locking pin (516), the second driven gear (654) configured to transfer the rotational movement of the second drive gear (652) to a locking pin (516) coupled to the winder (400), to rotate the winder (400).
13. The device (100) as claimed in claims 5 and 12, wherein the drive assembly (130) includes at least one actuator (660) having the first motor (600a) and the second motor (600b), the at least one actuator (660) configured to selectively actuate the first motor (600a) and the second motor (600b) to provide the first and second rotational actuations, respectively.
14. The device (100) as claimed in claim 13, wherein the drive assembly (130) comprises:
a. a first actuator (660a) coupled to the first motor (600a); and
b. a second actuator (660b) coupled to the second motor (600b).
15. The device (100) as claimed in claim 1, wherein the cutting assembly (110) and the extraction assembly (120) define a fluid path configured to convey at least one biological fluid from the cutting element (200) to the chamber (300) via the sheath (220), such that the fluid path is isolated from the handle (500), thereby rendering the handle (500) reusable.