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:
ATHERECTOMY DEVICE

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

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

FILED OF THE INVENTION
[001] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an atherectomy device.
BACKGROUND OF THE INVENTION
[002] Rotational atherectomy is an intervention technique to open clogged arteries. Rotational atherectomy is used for ostial, and heavily calcified lesions/lesions in the arteries. Rotational atherectomy uses a burr for ablation performed under supervised navigation and imaging.
[003] While performing rotational atherectomy, ablating head (or head) selection is important. Heads are single-use disposable component. During rotational atherectomy head’s shape and size are selected based upon characteristics of the clog in the artery. Crooked head is limited to creating small openings and they can damage the artery walls leaving big lesion fragments which can cause medical complications. Whereas, straight head faces challenges in effectively removing lesions, requiring longer time to operate.
[004] Therefore, there arises a need for an improved head that overcomes the problems associated with conventional heads of atherectomy devices.
SUMMARY OF THE INVENTION
[005] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[006] The present disclosure relates to an atherectomy device including a handle and a tubular shaft rotatably coupled to the handle. A head is coupled to a distal portion of the tubular shaft. The head has a distal portion provided with at least one curved edge and at least one flat edge.
BRIEF DESCRIPTION OF DRAWINGS
[007] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[008] Fig. 1 depicts a device 10, according to an embodiment of the present invention.
[009] Fig. 1a depicts a tubular shaft 13 of the device 10, according to an embodiment of the present invention.
[0010] Fig. 2 depicts a head 100 of the device 10, according to an embodiment of the present invention.
[0011] Fig. 2a depicts a head 200 of the device 10, according to an embodiment of the present invention.
[0012] Fig. 3 depicts a plurality of components of the device 10, according to an alternate embodiment of the present invention.
DETAILED DESCRIPTION OF DRAWINGS
[0013] Prior to describing the disclosure in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0014] 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.
[0015] 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.
[0016] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0017] The present disclosure relates to an atherectomy device (or device). The device is provided with a head for ablating lesions/deposits within the vasculature tissues (for example, arteries). In an embodiment, the head has an elongated tubular structure having a proximal portion and a distal portion. The distal portion of the head includes at least two sharp edges (or edges). In an embodiment, the edges of the head include at least one curved edge and at least one flat edge. The user of the device may toggle between the at least two edges for ablation by toggling a direction of rotation of the head of the device. For example, during clockwise rotation the flat edge of the head engages in ablation and during anti-clockwise rotation the curved edge of the head engages in ablation.
[0018] Now referring to the figures, Fig. 1 depicts an exemplary device 10 of the present disclosure used for atherectomy. The device 10 includes a handle 11, a tubular shaft 13, etc. The tubular shaft 13 is rotatably coupled to the handle 11.
[0019] The handle 11 is provided with a removably coupled a catheter unit 11a. The catheter unit 11a along with the tubular shaft 13 is discarded after every procedure of atherectomy.
[0020] Fig. 1a depicts an enlarged view of the tubular shaft 13. A head 100 is coupled to a distal portion of the tubular shaft 13.
[0021] Fig. 2 depicts the head 100 alone. The head 100 includes an elongated tubular structure having a proximal portion 100a and a distal portion 100b. The head 100 may be hollow or solid. In an exemplary embodiment, the proximal portion 100a is hollow thereby facilitating suction of the debris through the tubular shaft 13.
[0022] The proximal portion 100a of the head 100 is coupled to the tubular shaft 13 by for example, laser welding. A rotational motion of the tubular shaft 13 is transferred to the head 100, i.e., the head 100 is rotated by rotating the tubular shaft 13. Other functionally equivalent methods to couple the head 100 to the tubular shaft 13 are within the scope of the teachings of the present disclosure.
[0023] Outer diameter of the head 100 may range from 1.25 mm to 2.5 mm and the length of the head 100 may range from 2 mm to 10 mm. At least a portion of the head 100 is made of a biocompatible material including, but not limited to, stainless steel, nitinol, carbides, titanium etc.
[0024] The distal portion 100b of the head 100 includes at least two sharp edges (or edges), for example, at least one curved edge 101 and at least one flat edge 102 for ablation. The curved edge 101 ranges from 0.5 mm to 7 mm in length and the flat edge 102 ranges from 0.5 mm to 4 mm. In an exemplary embodiment, as shown in Fig. 2, the curved edge 101 is relatively longer than the flat edge 102.
[0025] The curved edge 101 and flat edge 102 of the head 100 may either be spaced apart or joined together. In an exemplary embodiment, as shown in Fig. 2, the curved edge 101 and flat edge 102 of the head 100 are spaced apart thereby defining a first gap 100c and a second gap 100d. The first gap 100c has a pre-defined width ranging from 0.25 mm to 2 mm and the second gap 100d has a pre-defined width ranging from 0.25 mm to 2 mm. In an embodiment, the first gap 100c is dimensionally almost similar to the second gap 100d. The fist gap 100c and the second gap 100d help to define the profiles of curved edge 101 and the flat edge 102 of the head 100. It also helps with the suction of the debris.
[0026] The head 100 is rotated either in a clockwise direction or an anti-clockwise direction. Rotational direction of the head 100 can be toggled by, for example, a bi-directional motor provided inside the handle 11 and coupled to the tubular shaft 13. The rotation speed of the head 100 is reduced to minimize damage caused by the rotation of the curved and flat edges 101, 102 to the inner walls of the arteries.
[0027] In an exemplary embodiment, during clockwise rotation, the flat edge 102 of the head 100 engages in ablation and during anti-clockwise rotation, the curved edge 101 of the head 100 engages in ablation or vice versa. The rotational direction is selected based upon factors such as lesion strength, clogging of the head 100 during the procedure, etc. at the discretion of the medical practitioner.
[0028] Still referring to Fig. 2, the curved edge 101 includes an arc of pre-defined length ranging from 0.5 mm to 7 mm. The curved edge 101 helps in ablating dense lesions or when the head 100 is lodged inside the lesion. The curved edge 101 can include a smooth or a rough surface. In an embodiment, the curved edge 101 includes a rough surface coated with diamond or titanium particles.
[0029] The flat edge 102 includes a linear length ranging from 0.5 mm to 4 mm. The flat edge 102 can include a smooth or a rough surface. In an embodiment, the flat edge 102 includes a rough surface coated with diamond or titanium particles. The flat edge 102 helps in effective ablation of softer/vulnerable/non-stenotic lesions ensuring minimal damage to the walls.
[0030] Additionally or optionally, at least a portion of the curved edge 101 and/or the flat edge 102 is provided with a pre-defined sharpness (like a cutting tool).
[0031] Fig. 2a depicts an alternate embodiment of head 200. Similar to head 100, the head 200 includes a proximal portion 200a, a distal portion 200b, a curved edge 201, a flat edge 202, etc. Further, the curved edge 201 and the flat edge 202 are spaced apart to define a first gap 200c and a second gap 200d (as shown in Fig. 2a).
[0032] The proximal portion 200a of the head 200 may be longer than the distal portion 200b. The proximal portion 200a is provided with at least one window 203 along the length of the proximal portion 100a as depicted in Fig. 2a. The window 203 helps in the suction of debris or particles during ablation. The window 203 ensures suction of bigger chunks of the lesion after ablation that might be difficult to suck from the hollow portion of the head 100.
[0033] Referring to back to Fig. 1, the device 10 provides rotational control of the head 100 and a suction mechanism over the head 100 to collect the debris during the procedure. The handle 11 of the device 10 houses a plurality of components.
[0034] Fig. 3 depicts exemplary components housed inside the handle 11 (as shown in Fig. 1). The components include, without limitation, a y-hub 15, a drive shaft 17, a motor 17a, a gear-belt mechanism 19, a control element (not shown), etc. The y-hub 15 helps to couple the tubular shaft 13 to a suction/vacuum source for providing suction around the head 100. The drive shaft 17 is removably coupled to the tubular shaft 13 and helps to rotate the tubular shaft 13. The motor 17a is operationally coupled to the drive shaft 17 by the gear-belt mechanism 19. The gear-belt mechanism 19 includes, for example, two gears coupled to each other by a belt. One of the two gears is coupled to the drive shaft 17 and the other gear is coupled to the motor 17a thereby transferring the rotational motion of the motor 17a to the drive shaft 17 and thereafter to the tubular shaft 13 and the head 100/200. The control mechanism controls the rotational speed and direction of the motor 17a as dictated by the medical practitioner.
[0035] Now according to an embodiment, during an atherectomy procedure, the head 100 along with the tubular shaft 13 is coupled to the drive shaft 17 of the device 10. The head 100 and the tubular shaft 13 are inserted in the body via a suitable opening under supervised imaging. Upon reaching the target site, i.e., the lesion in the artery, the head 100 is rotated in the clockwise direction at the discretion of the medical practitioner. As result, the flat edge 102 engages in ablation activity. The flat edge 102 ensures a safe opening in the lesion by providing maximal coverage radius and minimal damage to the arteries. The debris of the lesion are sucked back through the hollow portion of the head 100.
[0036] However, if the lesion is heavily calcified and the flat edge 102 is struggling to proceed. The rotation of the head 100 is toggled to anti-clockwise direction, thereby engaging the curved edge 101 in the ablation activity. The curved edge 101 easily pierces through the lesion and the flat edge 102 ensures the maximum radius.
[0037] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A device (10) comprising:
a. a handle (11);
b. a tubular shaft (13) rotatably coupled to the handle (11);
c. a head (100, 200) coupled to a distal portion of the tubular shaft (13), the head (100, 200) having a distal portion (100b, 200b) provided with at least one curved edge (101, 201) and at least one flat edge (102, 202).
2. The device (10) as claimed in claim 1, wherein the at least one curved edge (101, 201) and the at least one flat edge (102, 202) are spaced apart.
3. The device (10) as claimed in claim 1, wherein the proximal portion (200a) is longer than the distal portion (200b).
4. The device (10) as claimed in claim 1, wherein the proximal portion (200a) is provided with at least one window (203).
5. The device (10) as claimed in claim 1, wherein the curved edge (101) is relatively longer than the flat edge (102).
6. The device (10) as claimed in claim 1, wherein the head (100) has an outer diameter ranging from 1.25 mm to 2.5 mm.