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

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

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention pertains to a transseptal puncture device.
BACKGROUND OF INVENTION
[002] Transseptal puncture (TSP) is a minimal invasive surgical procedure to puncture the tissue wall (or septum) that divides the right and the left atria of the heart (i.e., interatrial septum) to access the other side of the heart. The TSP procedure is performed using a surgical device including a piercing mechanism used to puncture the septum. TSP is widely used to access the left atrium of the heart from the right atrium of the heart for diagnostic or therapeutic procedures including, mitral valve repair and/or replacement, left atrial appendage closure, endomyocardial biopsy, ablation procedures, etc.
[003] Ideally, a medical expert who performs the TSP requires a combination of medical instruments to execute the TSP. Conventionally, a dilator, preloaded within a sheath, is inserted into and navigated over a guidewire through a patient’s vasculature to a target site at the interatrial septum. Once the dilator is positioned, the guidewire is removed, and a transseptal needle is inserted through the dilator to puncture the septum and create an access point into the left atrium. Thus, conventional devices generally employ two separate instruments—the dilator and the transseptal needle — for this procedure. Therefore, the procedure to perform the transseptal puncture is more complex and requires more time. Further, the sterilization requirements are also higher. The needle, as a separate and independently maneuvered instrument, requires precise control and accuracy throughout the procedure, particularly during navigation and septal puncture. Any deviation or loss of precision can lead to procedural complications, such as inaccurate needle placement, puncture at an unintended or incorrect site, or even potential injury to surrounding structures. Since the needle is manually retracted by hand in conventional devices, the procedure is susceptible to human errors and has a high-risk potential for injury if the withdrawal is done improperly. Moreover, in a conventional device, time taken for a forward motion of the needle to puncture the septum wall is generally the same as a return motion of the needle. Consequently, there is a higher risk of damage in adjoining tissues.
[004] Therefore, there arises a need for a medical device for transseptal puncture that overcomes the problems associated with the conventional devices.
SUMMARY OF THE INVENTION
[005] The present invention relates to a transseptal puncture device (or device) for puncturing a septum wall. The device includes a needle with a puncturing tip provided at a distal end of the needle and configured to puncture the septum wall. The device includes an actuating assembly coupled to the needle and configured to drive the needle in a longitudinal direction. The actuation assembly includes an actuator configured to rotate about an axis and a driver rotatably coupled to the actuator. The driver has a peg. The actuation assembly includes an actuating rod coupled to the driver and the needle. The actuating rod includes a slotted member having a slot configured to receive the peg of the driver and an elongated member coupled to a proximal end of the needle. In response to the rotation of the actuator in a first predefined direction, the driver is configured to rotate and the peg is configured to slide within the slot towards a second end of the slot, causing the elongated member of the actuating rod to slide linearly in a forward direction and the needle to advance linearly to puncture the septum wall.
[006] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[007] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[008] Fig. 1 depicts a perspective view of a transseptal puncture device 100, in accordance with an embodiment of the present disclosure.
[009] Fig. 1A depicts a cross-sectional view of a proximal portion of the transseptal puncture device 100, in accordance with an embodiment of the present disclosure.
[0010] Fig. 1B depicts a cross-sectional view of a distal portion of the transseptal puncture device 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 2 depicts a perspective view of a dilator 110, in accordance with an embodiment of the present disclosure.
[0012] Fig. 2A depicts a transverse cross-sectional view of the dilator 110, in accordance with an embodiment of the present disclosure.
[0013] Fig. 3 depicts a perspective view of a handle 130, in accordance with an embodiment of the present disclosure.
[0014] Fig. 3A depicts the coupling of the handle 130 and the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0015] Fig. 3B depicts an exploded view of the handle 130 showing an actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0016] Fig. 3C depicts a perspective view of a first housing 134a of a housing 134 of the handle 130, in accordance with an embodiment of the present disclosure.
[0017] Fig. 4 depicts an exploded view of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0018] Fig. 5A depicts a perspective view of an actuator 202 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0019] Fig. 5B depicts a bottom view of the actuator 202 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0020] Fig. 6A depicts a perspective view of a driver 230 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0021] Fig. 6B depicts a cross-sectional view of the driver 230 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0022] Fig. 7 depicts a perspective view of an actuating rod 210 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0023] Fig. 8 depicts a perspective view of a resilient member 250 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0024] Fig. 9 depicts a perspective view of a fastener 270 of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0025] Fig. 10A depicts a default position of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0026] Fig. 10B depicts a default position of a needle 10, in accordance with an embodiment of the present disclosure.
[0027] Fig. 11A depicts an actuation position of the actuation assembly 200, in accordance with an embodiment of the present disclosure.
[0028] Fig. 11B depicts an actuation position of the needle 10, in accordance with an embodiment of the present disclosure.
[0029] Fig. 12 depicts a flowchart of a method 1200 for puncturing the atrial septum of a patient using the transseptal puncture device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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.
[0034] Various methods described herein may be practiced by combining one or more machine-readable storage media containing the code according to the present invention with appropriate standard computer hardware to execute the code contained therein. An apparatus for practicing various embodiments of the present invention may involve one or more computers (or one or more processors within a single computer) and storage systems containing or having network access to computer program(s) coded in accordance with various methods described herein, and the method steps of the invention could be accomplished by modules, routines, subroutines, or subparts of a computer program.
[0035] The present disclosure relates to a medical device for puncturing a septum of a patient’s heart. In an embodiment, the device is used to puncture the interatrial septum of the heart. The device integrates a dilator and a needle into a single unit, eliminating the need for a separate dilator and needle. This streamlines the procedure, reduces time for the procedure, and enhances overall procedural efficiency. Further, the device includes an actuation assembly with a quick return mechanism that causes the needle to retract quickly after puncturing. This minimizes the risk of damage to surrounding tissues. Furthermore, the device provides a precise and controlled puncturing of the interatrial septum of the heart, enhancing procedural accuracy and minimizing the risk of complications.
[0036] Now referring to figures, Fig. 1 depicts a perspective view of a transseptal puncture device 100, in accordance with an embodiment of the present disclosure. Fig. 1A and Fig. 1B depict cross-sectional views of a proximal and a distal portion of the transseptal puncture device 100. The transseptal puncture device 100 (interchangeably referred to as device 100 hereafter) is configured to puncture an atrial septum of a patient. The device 100 has a proximal end 100a and a distal end 100b. The device 100 includes a needle 10, a dilator 110, a handle 130, and an actuation assembly 200 (shown in Fig. 3A). The handle 130 is provided at the proximal end 100a of the device 100. The actuation assembly 200 is provided with the handle 130. The actuation assembly 200 is coupled to the needle 10 and provides a longitudinal motion to the needle 10, which is explained later in detail.
[0037] Figs. 2 to 2A depict various views of the dilator 110, in accordance with an embodiment of the present disclosure. The dilator 110 extends between a proximal end 110a and a distal end 110b, defining a length. The proximal end 110a of the dilator 110 is coupled to the handle 130 using a coupling technique including, but not limited to, welding, snap-fit, locking mechanism, etc. In an embodiment, the distal end 110b of the dilator 110 may be tapered to facilitate smooth entry and navigation of the dilator 110 to a target site (e.g., atrial septum) through the vasculature of the patient and minimize trauma to vascular tissue. Additionally, the dilator 110 may have a flexed portion 113 at the distal end 110b. The flexed portion 113 of the dilator 110 serves to align the dilator 110 to the target site. Optionally, the dilator 110 may be provided with serrations 115 for at least a partial length of the dilator 110. In the depicted embodiment, the serrations 115 are provided on the entire length of the dilator 110. The serrations 115 provide flexibility to the dilator 110 for easy navigation of the dilator 110 through the vasculature and positioning of the dilator 110 at the time of puncture. The diameter and the length of the dilator 110 may be chosen based on procedural requirements and the anatomy of the patient. In an embodiment, the outer diameter of the dilator 110 may range between 1 mm and 5 mm. The length of the dilator 110 may range between 600 mm and 1500 mm. In an embodiment, the length and the outer diameter of the dilator 110 are 670 mm and 2.83 mm, respectively. The dilator 110 may be made of a biocompatible material including, but not limited to low-density polyethylene (LDPE), medium-density polyethylene (MDPE), high-density polyethylene (HDPE), high-density polyethylene with barium sulfate (HDPE + BaSO₄), polyether block amide (PEBAX), nylon, etc. In an embodiment, the dilator 110 is made of low-density polyethylene (LDPE).
[0038] The dilator 110 is configured to expand the septum wall after the initial puncture is made by device 100. For example, the dilator 110 may be advanced through the puncture to gradually dilate the opening and expand it so that other devices like a catheter can be passed through to the other side of the heart. The dilator 110 has an elongated, tubular structure. The dilator 110 includes at least one lumen. In an embodiment, the dilator 110 includes a first lumen 111 and a second lumen 112. The first lumen 111 and the second lumen 112 extend from the proximal end 110a to the distal end 110b of the dilator 110. The first lumen 111 is configured to accommodate the needle 10 and the second lumen 112 is configured to receive a guidewire 20 (as depicted in Fig. 1B). The diameter of the first lumen 111 may be greater than or equal to the outer diameter of the needle 10. In an embodiment, the diameter of the first lumen 111 corresponds to the diameter of the needle 10. The diameter of the first lumen 111 may range between 0.7 mm and 1.3 mm. In an embodiment, the diameter of the first lumen 111 is 1.03 mm. The diameter of the second lumen 112 may be greater than or equal to the outer diameter of the guidewire 20. In an embodiment, the diameter of the second lumen 112 is greater than the outer diameter of the guidewire 20. The diameter of the second lumen 112 may range between 0.30 mm and 1.0 mm. In an embodiment, the diameter of the second lumen 112 is 0.90 mm.
[0039] In an embodiment, the needle 10 is disposed within the first lumen 111 of the dilator 110. The needle 10 is configured to slide within the first lumen 111 of the dilator 110. The needle 10 has an elongated structure. The needle 10 may feature a solid interior or a hollow interior for at least a partial length of the needle 10. The needle 10 may be made from a material including, but not limited to stainless steel (e.g., SS304, SS316, SS308, etc.) or any other suitable biocompatible material. In an embodiment, the needle 10 is made from SS304. In addition, the needle 10 has a puncturing tip 11 provided at a distal end of the needle 10. The puncturing tip 11 of the needle 10 is configured to pierce the target site or a target area such as the septum of the patient. In an embodiment, the puncturing tip 11 has a bevel or tapered structure to facilitate penetration through the septum more easily.
[0040] Fig. 3 depicts a perspective view of the handle 130 and Fig. 3A depicts coupling of the handle 130 and the actuation assembly 200, in accordance with an embodiment of the present disclosure. The handle 130 has an ergonomic shape, which enables a medical practitioner to grip and operate the device 100, comfortably. The handle 130 has a proximal end 130a and a distal end 130b. The handle 130 includes a guidewire port 130c and a dilator port 130d. The dilator port 130d is configured to receive, and couple with, a proximal portion of the dilator 110. The proximal portion of the dilator 110 may be coupled with the dilator port 130d using a coupling technique, such as, without limitation, welding, snap-fit, locking mechanism, etc. In an example implementation, the proximal portion of the dilator 110 is bonded with the dilator port 130d of the handle 130. The diameter of the dilator port 130d corresponds to the outer diameter of the proximal end 110a of the dilator 110. The guidewire port 130c has a tubular structure and is configured to receive the guidewire 20.
[0041] Fig. 3B depicts an exploded view of the handle 130 showing the actuation assembly 200, in accordance with an embodiment of the disclosure. The handle 130 includes a first housing 134a and a second housing 134b. The first housing 134a and the second housing 134b are coupled to form a housing 134 of the handle 130. The first housing 134a and the second housing 134b may be fixedly or removably coupled to form the housing 134. The first and second housings 134a, 134b may be coupled using a coupling method including, but not limited to welding, snap-fit, locking mechanism, etc. In an embodiment, the first and second housings 134a, 134b are coupled using a snap fit mechanism. The housing 134 of the handle 130 is configured to accommodate one or more components of the actuation assembly 200.
[0042] The second housing 134b may be a mirror image of the first housing 134a. Therefore, the structure of the handle 130 is described with reference to the first housing 134a. The structure of the second housing 134b can be referred from that of the first housing 134a as shown in the Fig. 3C. In an embodiment, the handle 130 includes a first channel 133, and a second channel 137. The first channel 133 has a proximal end and a distal end. The distal end of the first channel 133 is coupled to the first lumen 111 of the dilator 110 using a coupling technique including, but not limited to, laser welding, UV bonding, adhesive bonding, etc. In an exampled implementation, the distal end of the first channel 133 is bonded to a proximal end of the first lumen 111 of the dilator 110. The diameter of the first channel 133 may correspond to the diameter of the first lumen 111. The first channel 133 is tabular in structure and is configured to accommodate a portion of an actuating rod 210 of the actuation assembly 200. The first channel 133 enables the actuating rod 210 to move (or slide) within the first channel 133. The diameter of the first channel 133 is greater than the diameter of the actuating rod 210, ensuring smooth and unobstructed motion.
[0043] The second channel 137 extends longitudinally within the handle 130 from the guidewire port 130c to the dilator port 130d of the handle 130. Further, a proximal end of the second channel 137 extends outward from the housing 134 in a proximal direction. A distal end of the second channel 137 is coupled to the second lumen 112 of the dilator 110 using a coupling technique including, but not limited to, laser welding, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. In an example implementation, the distal end of the second channel 137 is coupled to a proximal end of the second lumen 112 using UV bonding. The coupling ensures a secure and sealed pathway between the second channel 137 and the second lumen 112. In an embodiment, the second channel 137 is tubular and is configured to receive the guidewire 20. The second channel 137 allows the guidewire 20 to be inserted from the guidewire port 130c into the second lumen 112. The diameter of the second channel 137 may correspond to the diameter of the guidewire 20.
[0044] Further, the handle 130 includes an aperture 131 at a bottom surface 138 of the housing 134. The aperture 131 is used to couple the handle 130 with the actuation assembly 200 as explained later in detail. Furthermore, the handle 130 includes an annular disc 132 disposed at the bottom surface 138 and having a hole 132a. The hole 132a of the annular disc 132 is axially aligned with the aperture 131. Moreover, the handle 130 includes a plurality of supporting columns 135 to provide structural support to the first channel 133 and the second channel 137. In an embodiment, the supporting column 135 has a rectangular shape, though, each supporting column 135 may have different shapes depending upon the strength required.
[0045] Fig. 4 depicts an exploded view of the actuation assembly 200, in accordance with an embodiment of the present disclosure. The actuation assembly 200 is configured to provide a longitudinal motion to the needle 10. In an embodiment, the actuation assembly 200 includes an actuator 202, a driver 230, a resilient member 250, the actuating rod 210, and a fastener 270.
[0046] Fig. 5A and 5B depict various views of the actuator 202, in accordance with an embodiment of the present disclosure. The actuator 202 is configured to rotate about an axis. The actuator 202 imparts a rotational motion to the driver 230. In an embodiment, the actuator 202 includes a shaft 203, and a disc 204. The disc 204 is positioned out of the handle 130, enabling easy handling and accessibility for the medical practitioner. For example, the disc 204 is positioned at a bottom end of the handle 130. The disc 204 may be generally circular. The disc 204 has a first surface 204a and a second surface 204b. The disc 204 may include grooves, notches, undulations, serrations, or the like, provided on the second surface 204b and/or the outer periphery of the disc 204. The grooves of the disc 204 provide a better grip to the actuator 202, reducing the user’s fatigue and improving overall performance. The disc 204 is rotatable about an axis. In an embodiment, the disc 204 is oriented such that the axis of rotation of the disc 204 is perpendicular to the longitudinal axis of the handle 130.
[0047] Optionally, the actuator 202 has a plurality of markings disposed on the second surface 204b of the disc 204. The plurality of marking includes a first marking 205a and a second marking 205b. The second marking 205b indicates a predefined rotational direction of the actuator 202. The pre-defined rotational direction corresponds to a direction in which the actuator 202 is to be rotated. The first marking 205a helps in indicating a position of the needle 10 during the operation of the device 100.
[0048] The shaft 203 extends from the first surface 204a of the disc 204 such that the shaft 203 is disposed within the handle 130. The shaft 203 is coupled to the driver 230. The shaft 203 may be provided at the center of the disc 204. The shaft 203 has a first end 203a and a second end 203b. The shaft 203 includes a coupling groove 206 provided at the first end 203a. The coupling groove 206 extends longitudinally towards the second end 203b of the shaft 203 for at least a partial length of the shaft 203. In an embodiment, the coupling groove 206 extends for a partial length of the shaft 203 as shown in Fig. 1A. The coupling groove 206 is configured to receive a corresponding portion (explained later) of the fastener 270. The coupling groove 206 may be partially threaded or fully threaded. In an embodiment, the coupling groove 206 is fully threaded having internal threads 206a. Further, the actuator 202 includes a rim 207 provided around the circumference of the shaft 203 at the second end 203b of the shaft 203. The rim 207 may have a pre-defined cross-sectional shape, such as square, rectangular, semi-circular, triangular, etc. In the depicted embodiment, the rim 207 has a semi-circular cross-section. It should be noted that although the shaft 203 and the disc 204 are described herein as integrally coupled, it is possible that the shaft 203 and the disc 204 may be separate components coupled together using a suitable coupling technique. The actuator 202 may be made of a material including, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (PEI), etc. In an embodiment, the actuator 202 is made of ABS.
[0049] Figs. 6A depicts a perspective view views of the driver 230 of the actuation assembly 200. Fig. 6B depicts a cross-sectional of the driver 230 of the actuation assembly 200, in accordance with an embodiment of the present disclosure. In an embodiment, the driver 230 disposed within the handle 130. The driver 230 is rotatably coupled to the actuator 202 and is configured to rotate in response to the rotation of the actuator 202. The driver 230 may be coupled to the actuator 202 using any suitable coupling including, but not limited to, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. In an embodiment, the driver 230 and the actuator 202 are coupled using the fastener 270. The driver 230 includes a disc 231 having a first surface 231a and a second surface 231b. The disc 231 has a circular shape, though the disc 231 may have any other shape, such as, without limitation, cube, cuboidal, polygonal prism, etc. The driver 230 includes a hole 232, a peg 233, and a projection 235. The hole 232 is configured to receive at least a portion of the fastener 270. The hole 232 has a first portion 232a provided towards the first surface 231a and a second portion 232b provided towards the second surface 231b. The first portion 232a may have a uniform or a tapered profile. In an embodiment, the first portion 232a is tapered such that the diameter of the first portion 232a gradually reduces towards the second portion 232b. The first portion 232a may be smooth, partially threaded, or fully threaded. The second portion 232b of the hole 232 may be fully threaded, semi-threaded, or smooth. In an embodiment, the first portion 232a is smooth and the second portion 232b of the hole 232 is fully threaded having threads 232e. The peg 233 extends from the first surface 231a. The peg 233 of the driver 230 is positioned eccentrically, i.e., the peg 233 is located closer to the circumference of the disc 231 than the center of the disc 231. The peg 233 is coupled to the actuating rod 210 and is configured to transfer the rotational motion of the driver 230 to the actuating rod 210. The projection 235 protrudes from the second surface 231b of the driver 230. The projection 235 is positioned eccentrically i.e., the peg 233 is located closer to the circumference of the disc 231 than the center of the disc 231. In an embodiment, the peg 233 and the projection 235 may be aligned. The projection 235 is coupled to the resilient member 250. The driver 230 may be made from a material, such as, without limitations, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (PEI), etc. In an embodiment, the driver 230 is made of ABS. It should be noted that although the disc 231, the peg 233, and the projection 235 are described as integrally coupled, it is possible that they are separate components coupled together using a suitable coupling technique.
[0050] Fig. 7 depicts a perspective view of the actuating rod 210 of the actuation assembly 200, in accordance with an embodiment of the present disclosure. The actuating rod 210 is coupled to the driver 230 and the needle 10. In an embodiment, the actuating rod 210 is longitudinally disposed within the handle 130 and has a proximal end 210a and a distal end 210b. The actuating rod 210 may be made of a material including but not limited to ABS, polycarbonate, PP, polyetherimide, etc. In an embodiment, the actuating rod 210 is made of ABS. The actuating rod 210 includes a slotted member 211 provided at the proximal end 210a of the actuating rod 210 and an elongated member 213 provided at the distal end 210b of the actuating rod 210. In an embodiment, the elongated member 213 has a cylindrical shape, though it may have any other shape. A proximal end of the elongated member 213 is coupled to the slotted member 211 and a distal end of the elongated member 213 is coupled to a proximal end of the needle 10 using, for example, UV bonding, adhesive bonding or laser welding. The elongated member 213 is slidably disposed within the second channel 137 of the handle 130 (as shown in Fig. 3A).
[0051] In an embodiment, the slotted member 211 has a rectangular shape with smooth edges though the slotted member 211 may have any other shape such as, without limitation square, circular, etc. The slotted member 211 has a first end 211a and a second end 211b. The slotted member 211 includes a slot 211c extending from the first end 211a to the second end 211b of the slotted member 211. The slot 211c is configured to receive the peg 233 of the driver 230. The peg 233 moves within the slot 211c between the first end 211a and the second end 211b. The sliding movement of the peg 233 within the slot 211c causes the actuating rod 210 to move linearly.
[0052] Fig. 8 depicts a perspective view of the resilient member 250 of the actuation assembly 200, in accordance with an embodiment of the present disclosure. The resilient member 250 is provided on the actuator 202 and coupled to the driver 230 and a handle 130. The resilient member 250 is disposed on the shaft 203 of the actuator 202 and configured to apply a biased force on the driver 230 and the actuator 202. The resilient member 250 includes a first end portion 251, a second end portion 253, and a plurality of coils 254 extending therebetween. The first end portion 251 extends along a horizontal axis (i.e., longitudinal) of the handle 130 and the second end portion 253 extends along a vertical axis of the handle 130. The coils 254 define a cavity 254a. The resilient member 250 is coupled to the driver 230 and the actuator 202 as follows. The coils 254 are wrapped around the shaft 203 of the shaft 203. In other words, the shaft 203 is disposed within the cavity 254a. The first end portion 251 is positioned against and coupled with the projection 235 of the driver 230. The second end portion 253 of the resilient member 250 is coupled to the handle 130. In an embodiment, the second end portion 253 is disposed in and fixedly coupled to a slot (not shown) provided on the annular disc 132 (as depicted in Fig. 3A) using, for example, snap-fit, locking mechanism, etc. The coupling of the resilient member 250 as explained herein helps in retaining the driver 230 and the actuator 202 at a default position. The resilient member 250 facilitates a quick return of the needle 10 to prevent damage to surrounding tissues.
[0053] The resilient member 250 is configured to provide a restoring force when subjected to deformation. The resilient member 250 may be a helical spring, a torsion spring, a compression spring, a coil, etc. The resilient member 250 may be made from a material such as steel, stainless steel, or other metals with suitable elasticity, or from polymers or composite materials that can achieve the desired spring properties.
[0054] Fig. 9 depicts a perspective view of the fastener 270, in accordance with an embodiment of the present disclosure. The fastener 270 is configured to couple the actuator 202 with the driver 230 thereby preventing any relative motion therebetween. The fastener 270 includes a head 271 and a shank 272 extending from the head 271. The shank 272 resides within the coupling groove 206 of the shaft 203 of the actuator 202 and the second portion 232b of the hole 232 of the driver 230. In an embodiment, the shank 272 may be cylindrical with a uniform diameter. In another embodiment, the shank 272 may have a generally cylindrical shape with a tapered diameter (e.g., frustum-shaped), for example, the diameter of the shank 272 may gradually decrease away from the head 271. The shape and dimensions of the coupling groove 206 and the second portion 232b of the hole 232 are designed accordingly. The shank 272 may be smooth, partially threaded, or fully threaded. In an embodiment, the shank 272 is provided with external threads 273 configured to mate with the internal threads 206a of the coupling groove 206 and with the threads 232e provided in the hole 232.
[0055] The head 271 resides within the first portion 232a of the hole 232. The diameter of the head 271 is greater than the diameter of the shank 272. In an embodiment, the head 271 has a circular shape though the head 271 may have any other shape including, but not limited to, hexagonal, pentagonal, square, or any other polygonal shape. The head 271 may have a uniform diameter or may be tapered. The shape and dimensions of the first portion 232a of the hole 232 is designed accordingly. In an embodiment, the head 271 has a tapered shape with a gradually reducing diameter towards the shank 272. In an embodiment, the head 271 includes a groove 275 provided on a top surface of the head 271. The groove 275 may have a shape including, but not limited to crisscross, circular, oval, hexagonal, pentagonal, or other polygonal configurations. In one embodiment, the groove 275 is in the form of a crisscross. The groove 275 enables a user to hold and manipulate the fastener 270 using an external tool, such as a screwdriver, to fixedly couple the driver 230 and the actuator 202. The fastener 270 may be made of a material including, but not limited to SS304, SS316, SS308, etc. In one embodiment, the fastener 270 is made of SS304.
[0056] An embodiment of assembling the actuation assembly 200 and the handle 130 is described below. The shaft 203 of the actuator 202 passes through the aperture 131 of the handle 130 into the interior of the handle 130. The rim 207 seats within the aperture 131, preventing the actuator 202 from sliding out of the handle 130. The shape and dimensions of the aperture 131 correspond to the shape and dimensions of the rim 207. The resilient member 250 disposed around the shaft 203 and the second end portion 253 is coupled with the housing 134 of the handle 130. The driver 230 is positioned at the first end 203a of the shaft 203 such that the coupling groove 206 of the shaft 203 and the second portion 232b of the hole 232 of the driver 230 are axially aligned and the projection 235 abuts the first end portion 251 of the resilient member 250. The fastener 270 is inserted into the coupling groove 206 through the hole 232 of the driver 230 and screwed until the head 271 of the fastener 270 resides within the first portion 232a of the hole 232, and the shank 272 partially resides in the hole 232 and the coupling groove 206, securely coupling the actuator 202 and the driver 230. The peg 233 of the driver 230 is disposed within the slot 211c of the actuating rod 210.
[0057] An embodiment of the working of the device 100 is now explained. Figs. 10A and 10B depict the default position of the actuation assembly 200 and the needle 10, respectively, in accordance with an embodiment of the present disclosure. The device 100 is set at the default position while navigating the device 100 to the target site. In the default position, the puncturing tip 11 of the needle 10 resides within the second lumen 112 of the dilator 110 as shown in Fig. 10B. The puncturing tip 11 remains at a predefined distance from the distal end 110b of the dilator 110. In an embodiment, the predefined distance may be between 3 mm and 4 mm. This ensures that the puncturing tip 11 does not inadvertently cause damage to surrounding tissues or vasculature during navigation of the dilator 110. Additionally, the first marking 205a on the actuator 202 aligns with a first reference marker 139a provided on a bottom side 139 of the handle 130. The first reference marker 139a indicates the default position of the puncturing tip 11. At the default position, the peg 233 of the driver 230 is at the first end 211a of the slot 211c.
[0058] To activate (or actuate) the needle 10, the medical practitioner rotates the actuator 202 in a first predefined direction, for example, counter-clockwise, as indicated by the first marking 205a. The rotation of the actuator 202 in the first predefined direction causes the driver 230 to rotate in the same direction. As a result, peg 233 of the driver 230 slides (or moves) within the slot 211c of the actuating rod 210 from the first end 211a towards the second end 211b. The sliding motion of the peg 233 within the slot 211c towards the second end 211b causes the actuating rod 210 to linearly move forward, which, in turn, advances the needle 10 in the forward (or distal) direction. In response to rotating the actuator 202 by a predefined angle, the peg 233 moves from the first end 211a to the second end 211b of the slot 211c, causing the needle 10 to move from the default position to an actuation position. Consequently, in the actuation position, the puncturing tip 11 of the needle 10 extends out of the dilator 110 and pierces the target site, creating a puncture in the septum. The actuation position corresponds to the distal-most position of the puncturing tip 11. Fig. 11A and 11B depict an actuation position of the actuation assembly 200 and the needle 10 within the dilator 110, respectively, in accordance with an embodiment of the present disclosure. As shown, in the actuated position, the peg 233 is at the second end 211b of the slot 211c, and the actuating rod 210 is at its distal-most position. The predefined angle may be up to 180°. In an embodiment, the predefined angle is 180 degrees. The rotation of the driver 230 also causes the resilient member 250 to rotate and get compressed. In the actuated position, the resilient member 250 is in a compressed state, storing potential energy. A second reference indicator 139b on the bottom side 139 of the handle 130 indicates the actuated position of the puncturing tip 11 and corresponds to the predefined angle. The user rotates the actuator 202 until the first marking 205a on the actuator 202 aligns with the second reference indicator 139b. Thus, the first marking 205a and the second reference indicator 139b visually assist the user to move the needle 10 to the actuation position.
[0059] Thereafter, the medical practitioner may stop applying rotational force to the actuator 202, such as by releasing it. Upon release, the actuator 202 ceases its rotational movement. Upon cessation of the rotation movement of the actuator 202, the compressed resilient member 250 then exerts a restorative (or biasing) force, causing the actuator 202 and the driver 230 to rotate in a second predefined direction (which is opposite to the first predefined direction) to respective default positions. The rotation of the actuator 202 and the driver 230 in the second predefined direction to the default position, retracts the peg 233 from the second end 211b to the first end 211a of the slot 211c, thereby retracting the actuating rod 210 in the liner backward direction. As a result, the puncturing tip 11 of the needle 10 is retracted into the dilator 110 to the default position. Further, the first marking 205a on the actuator 202 aligns with the first reference marker 139a. Thus, the actuation assembly 200 automatically moves the needle 10 from the forward position to the default position. The resilient member 250 facilitates the needle 10 to quickly return to the default position. The quick-return mechanism of the device 100 as described herein prevents damage to surrounding tissues during the puncturing.
[0060] According to an embodiment, the device 100 may include a conducting element wound on the actuating rod 210 and coupled to an RF generator (RF) (not shown). The conducting element may be disposed of at any other location-based upon requirements. A distal end of the conducting element is coupled to the outer surface of the needle 10 using, for example, wounding, soldering, welding, or the like. The conducting element is configured to transfer an RF excitation signal received from the RF generator to the needle 10. The conducting element is made of a material, such as, without limitation, copper, nickel, aluminum, brass or any material capable of conducting RF signals. In an example implementation, the conducting element is a wire made of copper. The RF generator is capable of generating the RF excitation signal, for example, RF pulses. Various parameters (e.g., frequency, intensity, number of pulses, duty cycle, resistance etc.) of the RF excitation signal may be chosen based on procedural requirements. The needle 10 may be configured to deliver the RF excitation signal at the target site. This allows the device 100 to puncture the septum using the RF energy. It should be understood that the conducting element is optional, and accordingly, in an embodiment, the device 100 may not include these components.
[0061] Fig. 12 depicts a flowchart of a method 1200 for puncturing the atrial septum of a patient using the device 100, according to an embodiment of the present disclosure. The method 1200 may be performed under fluoroscopic guidance or any other imaging guidance techniques.
[0062] At step 1201, the dilator 110 along with guidewire 20 is inserted into a patient’s body via an appropriate vascular access point, e.g., through the transfemoral vein of the patient. In an example implementation, the guidewire 20 may have a J-shaped tip to prevent trauma to the vasculature during the navigation of the dilator 110.
[0063] At step 1203, the dilator 110 is navigated through the patient’s vasculature to a target site. The navigation may be performed with the help of imaging guidance techniques. At this stage, the needle 10 and the actuation assembly 200 are in the default position. That is, the needle 10 remains inside the dilator 110 and the puncturing tip 11 of the needle 10 remains enclosed within the dilator 110. In another embodiment, the dilator 110 may be inserted and navigated to the target site using an introducer sheath. In this case, the dilator 110 is inserted into the introducer sheath and the introducer sheath is navigated to the target site.
[0064] At step 1205, once the dilator 110 is positioned at the target site (such as septum), the needle 10 is advanced to puncture the target site (e.g., the septum) using the actuating assembly 200. For example, the actuator 202 is rotated in the pre-defined direction to cause the needle 10 to undergo a translation motion as explained earlier, and puncture the septum. Before advancing the needle 10, the guidewire 20 is withdrawn into the dilator 110. This is done so that the guidewire 20 does not obstruct the motion of the needle 10 while puncturing the septum. The medical practitioner rotates the actuator 202 for the pre-defined degrees of rotation to advance the needle 10 to the actuation position and puncture the septum. The medical practitioner then releases the actuator 202. The quick return mechanism of the actuation assembly 200 ensures that the needle 10 automatically returns to the default position quickly as explained earlier.
[0065] At step 1207, the dilator 110 is withdrawn from the patient’s body
[0066] The device of the present disclosure offers several advantages over the conventional instrument. Unlike conventional instruments having a separate dilator and a needle, the present device integrates the dilator and the needle into a single unit. Therefore, the present device decreases the number of instruments needed for a procedure and reduces procedural complexity. Further, the proposed device eliminates the need to switch between multiple components, thereby, reducing the overall procedure time. The present device provides a quick return mechanism that offers precise motion to the needle for accurate puncture of the septum of the heart and minimizes damage to surrounding tissues. Thus, the device increases the overall efficiency of the procedure and improves procedural outcomes.
[0067] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A device (100) for puncturing a septum wall, the device (100) comprising:
a. a needle (10) comprising a puncturing tip (11) provided at a distal end of the needle (10) and configured to puncture the septum wall;
b. an actuating assembly (200) coupled to the needle (10) and configured to drive the needle (10) in a longitudinal direction, the actuation assembly (200) comprising:
i. an actuator (202) configured to rotate about an axis;
ii. a driver (230) rotatably coupled to the actuator (202) and comprising a peg (233); and
iii. an actuating rod (210) coupled to the driver (230) and the needle (10), the actuating rod (210) comprising a slotted member (211) having a slot (211c) configured to receive the peg (233) of the driver (230), and an elongated member (213) coupled to a proximal end of the needle (10);
c. wherein in response to the rotation of the actuator (202) in a first predefined direction, the driver (230) is configured to rotate and the peg (233) is configured to slide within the slot (211c) towards a second end (211b) of the slot (211c), causing the elongated member (213) of the actuating rod (210) to slide linearly in a forward direction and the needle (10) to advance linearly to puncture the septum wall.
2. The device (100) as claimed in claim 1, wherein the device (100) comprises a dilator (110) comprising a first lumen (111) configured to accommodate the needle (10).
3. The device (100) as claimed in claim 2, wherein the rotation of the actuator (202) in a pre-defined direction by a predefined angle from a default position of the actuator (202) causes the needle (10) to advance from a default position to an actuation position; wherein in the default position of the needle (10), the puncturing tip (11) of the needle (10) resides within the dilator (110) at a predefined distance from the distal end (110b) of the dilator (110); and wherein in the actuated position of the needle (10), the puncturing tip (11) of the needle (10) extends out of a distal end (110b) of the dilator (110).
4. The device (100) as claimed in claim 2, wherein the dilator (110) comprises serrations (115) provided on an outer surface of the dilator (110).
5. The device (100) as claimed in claim 2, wherein the dilator (110) comprises a second lumen (112) configured to accommodate a guidewire (20).
6. The device (100) as claimed in claim 2, wherein the device (100) comprises a handle (130) coupled to a proximal end (110a) of the dilator (110), the handle (130) comprising a first channel (133) coupled to the first lumen (111) of the dilator (110) and configured to receive the elongated member (213) of the actuating rod (210), wherein the elongated member (213) is configured to slide within the first channel (133).
7. The device (100) as claimed in claim 6, wherein the handle (130) comprises a second channel (137) configured to provide a passage for guidewire (20).
8. The device (100) as claimed in claim 1, wherein the actuator (202) comprises:
a. a disc (204) rotatable about an axis; and
b. a shaft (203) extending from a first surface (204a) of the disc (204) and coupled to the driver (230);
c. wherein the driver (230) is configured to rotate in response to the rotation of the disc (204).
9. The device (100) as claimed in claim 8, wherein the shaft (203) of the actuator (202) and the driver (230) are coupled using a fastener (270) having a head (271) and a shank (272); wherein driver (230) comprises a hole (232) having a first portion (232a) and a second portion (232b), wherein the second portion (232b) of the hole (232) of the driver (230) and a coupling groove (206) of the shaft (203) are configured to receive the shank (272) of the fastener (270), and the first portion (232a) of the hole (232) of the driver (230) is configured to receive the head (271) of the fastener (270).
10. The device (100) as claimed in claim 8, wherein the actuator (202) comprises a rim (207) provided around the circumference of the shaft (203) at a second end (203b) of the shaft (203) and disposed within an aperture (131) of the handle (130).
11. The device (100) as claimed in claim 1, wherein the peg (233) and the projection (235) of the driver (230) are positioned eccentrically on a first surface (231a) and a second surface (231b) of a disc (231) of the driver (230), respectively.
12. The device (100), as claimed in claim 1, wherein the device (100) comprises a conducting element wound on the actuating rod (210) and coupled to an RF generator, the conducting element is configured to transfer an RF excitation signal received from the RF generator to the needle (10).
13. The device (100) as claimed in claim 1, wherein the actuation assembly (200) comprises a resilient member (250) provided on the actuator (202) and coupled to the driver (230) and a handle (130), wherein the resilient member (250) comprises:
a. a first end portion (251) coupled to a projection (235) of the driver (230);
b. a second end portion (253) coupled to the handle (130);
c. a plurality of coils (254) extending between the first end portion (251) and the second end portion (253), the plurality of coils (254) wound around the shaft (203);
d. wherein in response to the cessation of the rotational movement of the actuator (202), the resilient member (250) is configured to apply biasing force on the projection (235) of the driver (230) such that the driver (230) rotates in a second predefined direction, causing the peg (233) to slide within the slot (211c) towards a first end (211a) of the slot (211c) which in turn drives the actuating rod (210) to slide linearly in a backward direction, thereby retracting the needle (10).