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:
MEDICAL INSTRUMENT FOR TRANSSEPTAL PUNCTURE WITH QUICK RETURN MECHANISM
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 instrument. More specifically, the present invention relates to a medical instrument for a transseptal puncture.
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 is inserted through a patient’s vasculature to the right atrium over a guidewire. Upon reaching the target site (septum), the medical expert removes the guidewire and advances a transseptal needle through the dilator to the target site, to pierce an opening inside the septum. The conventional devices, thus, use two separate instruments – the dilator and the needle. 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 INVENTION
[005] The present disclosure relates to an instrument for puncturing a septum wall. In an embodiment, the instrument includes a handle, a dilator, a needle, and an actuation assembly. The dilator is coupled to the handle at a proximal end and includes a first lumen. The needle is disposed within the first lumen of the dilator. The needle includes a tip at a distal end, configured to puncture the septal wall. The actuation assembly is coupled to the needle and configured to drive the needle in a longitudinal direction. The actuation assembly includes an actuator, a driver, an arm and a slider. The actuator is coupled to the handle and is configured to rotate about an axis. The driver includes a peg. The driver is coupled to the actuator and is configured to rotate in response to the rotation of the actuator. The arm includes a first slot and a second slot and. The arm is coupled to the driver and pivotably coupled to the handle. The arm is configured to oscillate about a pivot point in response to rotation of the driver. The slider is coupled to the needle. The slider includes a peg. The peg of the driver is slidably disposed within the second slot of the arm and the peg of the slider is slidably disposed within the first slot of the arm. The peg of the driver is configured to slide within the second slot in response to the rotation of the actuator, causing the arm to oscillate about the pivot point. In response to the oscillatory motion of the arm, the peg of the slider is configured to slide within the first slot, causing the slider and the needle to move linearly.
[006] The present disclosure further relates to an actuation assembly for actuating a needle to puncture a transeptal wall. In an embodiment, the actuation assembly includes an actuator, a driver, an arm and a slider. The actuator is coupled to a handle and is configured to rotate about an axis. The driver is coupled to the actuator and is configured to rotate in response to the rotation of the actuator. The arm includes a first slot and a second slot. The arm is coupled to the driver and pivotably coupled to the handle. The arm is configured to oscillate about a pivot point in response to the rotation of the driver. The slider is coupled to a needle. The slider includes a peg, slidably disposed within the first slot of the arm. The driver includes a peg slidably disposed in the second slot of the arm. The peg of the driver is configured to slide within the second slot of the arm in response to the rotation of the actuator, causing the arm to oscillate about the pivot point. In response to the oscillatory motion of the arm, the peg of the slider is configured to slide within the first slot, causing the slider and the needle to move linearly.
[007] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1a depicts a perspective view of an instrument 100 for puncturing a transseptal wall, according to an embodiment of the present disclosure.
[0010] Fig. 1b depicts a section view of a proximal portion of the instrument 100 showing a handle 130, according to an embodiment of the present disclosure.
[0011] Fig. 2 depicts an exploded view of the handle 130 illustrating an actuating assembly, according to an embodiment of the present disclosure.
[0012] Fig. 2a depicts perspective views of an actuator 150, according to an embodiment of the present disclosure.
[0013] Fig. 2b depicts a perspective view of a driver 230, according to an embodiment of the present disclosure.
[0014] Fig. 2c depicts a perspective view of an arm 210, according to an embodiment of the present disclosure.
[0015] Fig. 2d depicts a perspective view of a needle 270, according to an embodiment of the present disclosure.
[0016] Figs. 3a, 3b and 3c depict illustrated views of the instrument 100 showing positions of the needle 270 during the operation of the instrument 100, according to an embodiment of the present disclosure.
[0017] Fig. 4 depicts a flowchart of an exemplary method 400 of using the instrument 100, according to an embodiment of the present disclosure.
[0018] Fig. 5 depicts a perspective view of an instrument 500 for puncturing a transseptal wall, in accordance with another embodiment of the present disclosure.
[0019] Fig. 5a depicts a cross-section view of the instrument 500, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] The present disclosure relates to a medical instrument for puncturing a septum of a patient. In an embodiment, the instrument is used to puncture the interatrial septum or the fossa ovalis of the heart. The instrument integrates a dilator and a needle into a single unit, eliminating the need for separate dilator and needle. This streamlines the procedure, reduces time for the procedure and enhances overall procedural efficiency. Further, the instrument includes a quick return mechanism that causes the needle to retract quickly after puncturing. This reduces the risk for tissue damage.
[0026] Now referring to the figures, Fig. 1a depicts a perspective view of an exemplary instrument 100 for puncturing a septum wall, according to an embodiment. The instrument 100 has a proximal end 100a and a distal end 100b. In an embodiment, the instrument 100 includes a dilator 110, a needle 270 (shown in Fig. 2), a handle 130, and an actuating assembly (interchangeably referred to as an actuation assembly).
[0027] The dilator 110 is configured to expand the septum wall after the initial puncture is made by instrument 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 is located towards the distal end 100b of the instrument 100. The dilator 110 has a proximal end 110a and a distal end 110b. The dilator 110 has an elongated, tubular structure having at least one lumen extending for the entire length of the dilator 110. In an embodiment, the dilator 110 includes a first lumen (not shown) configured to receive the needle 270. The dilator 110 is coupled to the handle 130 at the proximal end 110a of the dilator 110. The dilator 110 may be fixedly coupled to the handle 130 using a coupling technique, such as, without limitation, bonding, ultrasonic welding, etc. In an example implementation, the proximal end 110a of the dilator 110 is bonded with the handle 130. The dilator 110 may be provided with serrations (not shown) on the outer surface for at least a partial length of the dilator 110. The serrations 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 dilator 110 may be made from a material, such as, but not limited to low density polyethylene (LDPE), medium density polyethylene (MDPE), high density polyethylene (HDPE) combined with barium sulfate (BaSO4), polyether block amide (PEBAX), nylon, etc. In an embodiment, the dilator 110 is made from HDPE. The length, an outer diameter and an inner diameter of the dilator 110 may be chosen based upon procedural requirements and the anatomy of the patient. In an embodiment, the outer diameter of the dilator 110 ranges from 1 mm to 5 mm and the length of the dilator 110 ranges from 600 mm to 1500 mm. In an example implementation, the outer diameter and the length of the dilator 110 are 2.76 mm and 700 mm, respectively. The inner diameter of the dilator 110 may be chosen to be greater than or equal to an outer diameter of the needle 270. According to an embodiment, the distal end 110b of the dilator 110 may be tapered. The tapered structure of the distal end 110b of the dilator 110 facilitates easier entry and navigation through a patient’s vasculature and minimizes trauma to vascular tissue.
[0028] The handle 130 is disposed at the proximal end 100a of the instrument 100. Fig. 1b depicts a sectional view of the handle 130 according to an embodiment. The handle 130 enables a user to hold and operate the instrument 100. The handle 130 has a proximal end 130a and a distal end 130b. The handle 130 may have an ergonomic shape, which enables a medical practitioner to comfortably grip and operate the instrument 100. In the depicted embodiment, the handle 130 has a generally polygonal shape. The handle 130 may be made from a material, such as, without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene (PP), polyetherimide, etc. In an embodiment, the handle 130 is made from ABS. The handle 130 has a hollow interior to house various components for actuation of the needle 270. The handle 130 includes a casing 130c (shown in Fig. 2) having a hollow interior to house various components of the actuation assembly (explained later). In the depicted embodiment, the casing 130c has an integrated structure. In another embodiment, the casing 130c may be formed by coupling two sections (not shown) using any coupling technique, for example, snap-fit, stud-groove coupling, fasteners, bonding, welding, etc.
[0029] In an embodiment, the handle 130 includes a first tubular portion 131a extending from the distal end 130b of the handle 130 into the interior of the casing 130c for a pre-defined distance. The first tubular portion 131a includes a first cavity 131 provided centrally and extending for the length of the first tubular portion 131a. The first cavity 131 receives, and is fixedly coupled with, the proximal end 110a of the dilator 110 as shown in Fig. 2. The diameter of the first cavity 131 corresponds to the outer diameter of the dilator 110. Further, a portion of the needle 270 is slidably disposed within the first cavity 131. Since the outer diameter of the dilator 110 is greater than the outer diameter of the needle 270, there is a gap between an inner surface of the first tubular portion 131a and the outer surface of the needle 270. In an embodiment, a sealing layer 131b is provided in the gap between an inner surface of the first tubular portion 131a and the outer surface of the needle 270 as shown in Fig. 1b. The sealing layer 131b makes an airtight seal and prevents blood leak while allowing longitudinal movement of the needle 270. In an embodiment, the sealing layer 131b is made of a polymeric material, such as, without limitation, polytetrafluoroethylene (PTFE), nitrile, silicone, fluorocarbon, polyurethane, etc. In an example implementation, the sealing layer 131b is made of nitrile.
[0030] In an embodiment, the handle 130 includes a first port 132 provided at the proximal end 130a of the handle 130. The first port 132 is provided for allowing water or sterile saline to flush out any debris or residual fluids to prevent clogs or obstruction within the needle 270. A second tubular portion 133a extends from the first port 132 into the interior of the casing 130c such that a distal end of the second tubular portion 133a resides within the interior of the casing 130c. The second tubular portion 133a includes a second cavity 133 extending for the length of the second tubular portion 133a. A proximal section of the needle 270 is slidably disposed within the second cavity 133. The diameter of the second cavity 133 corresponds to the outer diameter of the needle 270. Threads 133b are provided on outer surface of the second tubular portion 133a at the proximal end of the second tubular portion 133a. The threads 133b may be used to couple the instrument 100 with an external system, for example, a syringe to flush out the needle 270 with heparin, or a contrast delivery system for injecting a contrasting agent into a patient’s body to enhance visibility of the vasculature under an imaging technique, for precise navigation of the dilator 110 through the vasculature, to the target site.
[0031] The handle 130 may be include a slab 134a provided on an inner face of the casing 130c at a bottom end of the casing 130c. The slab 134a may have a pre-defined shaped, for example, cuboidal as shown in Fig. 2. The slab 134a includes an aperture 134 provided on a side face of the slab 134a.
[0032] According to an embodiment, the handle 130 may include a radiofrequency (RF) connector port 136 configured to connect with an RF generator (not shown). As shown, the RF connector port 136 may be provided below the first port 132. It should be understood though that the RF connector port 136 may be disposed at any other location based upon requirements. A third tubular portion 135b extends from the RF connector port 136 into the casing 130c such that a distal end of the third tubular portion 135b is disposed within the interior of the casing 130c. A conducting element 135a is coupled to the third tubular portion 135b, for example, at the distal end of the third tubular portion 135b. The conducting element 135a is wound on an outer surface of the needle 270. A distal end of the conducting element 135a is coupled to the outer surface of the needle 270 using, for example, wounding, soldering, welding or the like. The conducting element 135a is configured to transfer an RF excitation signal received from the RF generator to the needle 270.The conducting element 135a 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 135a is a wire made of copper. The conducting element is coupled to the RF generator. 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, etc.) of the RF excitation signal may be chosen based upon procedural requirements. The needle 270 may be configured to deliver the RF excitation signal at the target site. This allows the instrument 100 to puncture the septum using the RF energy. It should be understood that the RF connector port 136, the third tubular portion 135b and the conducting element 135a are optional, and accordingly, in an embodiment, the instrument 100 may not include these components.
[0033] The actuation assembly is coupled to the needle 270 and is configured to drive the needle 270 in a longitudinal direction. In an embodiment, the actuation assembly includes an actuator 150, an arm 210, a driver 230 and a slider 250.
[0034] The actuator 150 is coupled to the handle 130, for example, to the casing 130c at a lateral face 130d (shown in Fig. 1) of the casing 130c. The actuator 150 is rotatable and is configured to rotate about an axis. Fig. 2a depicts the actuator 150, according to an embodiment. The actuator 150 may have any regular or irregular shape, such as, without limitations, circular, triangular, rectangular, square, kite, rhombus, trapezoid, ellipse, etc. In an embodiment, the actuator 150 has a concave polygonal shape with curved sides, in which at least one side may be provided with notches (or other surface features, such as, grooves, undulations, etc.) for improved grip on the actuator 150. The actuator 150 may be made from any suitable material, such as, without limitation, ABS, polycarbonate, PP, polyetherimide, etc. In an embodiment, the actuator 150 is made of ABS. The actuator 150 has a first side 150a facing away from the handle 130 and a second side 150b facing the handle 130. The first side 150a of the actuator 150 may include one or more markings 160 indicating a pre-defined rotational direction. The pre-defined rotational direction corresponds to a direction in which the actuator 150 is to be rotated. In the depicted embodiment, the pre-defined rotational direction is anticlockwise. In another embodiment, the pre-defined rotational direction may be clockwise. The actuator 150 includes a projection 152 provided on the second side 150b. The projection 152 extends away from the second side 150b of the actuator 150 into the interior of the handle 130. An aperture (not shown) is provided on the lateral face 130d of the casing 130c of the handle 130 to provide a passage to the projection 152 such that the projection 152 is free to rotate along its longitudinal axis. The projection 152 may be integrally coupled (e.g., extruded) with the actuator 150. Alternately, the projection 152 may be a separate component coupled with the actuator 150 using a technique, for example, bonding or fasteners. In an embodiment, the actuator 150 is a rotating knob.
[0035] The driver 230 is rotatably coupled with the actuator 150. The driver 230 is configured to rotate in response to the rotation of the actuator 150. The driver 230 is disposed inside the casing 130c. Fig. 2b illustrates the driver 230, according to an embodiment. In an embodiment, the driver 230 is cylindrical, though the driver 230 may have any other shape, such as, without limitation, cube, cuboidal, polygonal prism, etc. The driver 230 may be made from a material, such as, without limitations, ABS, polycarbonate, PP, polyetherimide, etc. In an embodiment, the driver 230 is made from ABS. The driver 230 includes an opening 232 provided centrally, a peg 234, an inner edge 230a and an outer edge 230b. The opening 232 is configured to receive the projection 152. The projection 152 is coupled with the opening 232 using, for example, bonding or a fastener(s), thereby, rotatably coupling the actuator 150 and the driver 230. The cross-sectional shape and dimensions of the opening 232 correspond to the cross-sectional shape and dimensions of the projection 152. The dimensions of the driver 230 may be chosen based upon requirements. In an embodiment, the diameter of the driver 230 may be between 10 mm and 40 mm. In an example implementation, the diameter of the driver 230 may be 15 mm.
[0036] The peg 234 extends from a side 230c facing away from the actuator 150 into the interior of the handle 130. The peg 234 is positioned eccentrically on the side 230c of the driver 230. In an embodiment, the peg 234 may be positioned towards the outer edge 230b of the driver 230. In another embodiment, the peg 234 may be positioned towards the inner edge 230a of the driver 230. The peg 234 is configured to rotate in response to the rotation of the driver 230 in the same rotational direction. In an embodiment, the peg 234 has a cylindrical shape, though the peg 234 may have any other suitable shape. The diameter of the peg 234 may range between 1 mm and 5 mm. In an embodiment, the diameter of the peg 234 is 2.5 mm. The peg 234 is coupled with the arm 210 as explained later. Though in the depicted embodiment, the peg 234 is shown as integrally coupled (e.g., extruded) to the driver 230, in another embodiment, the peg 234 may be a separate component coupled to the driver 230 using a technique such as, UV bonding, laser welding, screwed, etc.
[0037] The arm 210 is coupled to the driver 230 using the peg 234. Now referring to Fig. 2c, the arm 210 includes a pin 211 and at least one slot, for example, a first slot 213 and a second slot 215. The arm 210 may be in the form of a plate. In an embodiment, the arm 210 has a rectangular shape with curved ends, though the arm 210 may have any other shape. The arm 210 may be made from a material, such as, without limitation, ABS, polycarbonate, PP, polyetherimide, etc. In an embodiment, the arm 210 is made from ABS. The arm 210 has a first end 210a and a second end 210b.
[0038] In an embodiment, the pin 211 is disposed at the first end 210a of the arm 210. The pin 211 extends outwards from the surface of the arm 210. The pin 211 is disposed within the aperture 134 of the handle 130, thereby pivotably coupling the arm 210 with the handle 130, and forming a pivot point. The pin 211 may be integrally coupled (e.g., extruded) with the arm 210 as shown. Alternately, the pin 211 may be a separate component coupled to the arm 210 using a technique, for example, bonding, laser welding, or fasteners. In an embodiment, the pin 211 has a cylindrical shape though the pin 211 may have any other suitable shape. The diameter of the pin 211 may range between 2 mm and 6 mm. In an embodiment, the diameter of the pin 211 is 4 mm. The pin 211 is coupled with the aperture 134 such that the pin 211 is rotatable around its longitudinal axis, which is perpendicular to the longitudinal axis of the instrument 100. The pin 211 acts as a pivot for the arm 210 to oscillate around the longitudinal axis of the pin 211. The aperture 134 restricts any linear movement of the arm 210 and allows the angular movement of the arm 210. The arm 210 is configured to undergo an angular rotation (or oscillation) in response to the rotation of the diver 230 as explained later.
[0039] The first slot 213 is provided towards the second end 210b of the arm 210. The first slot 213 may have a pre-defined shape such as rectangular or rectangular with curved edges, etc. In an embodiment, the first slot 213 has a rectangular shape with curved edges. The length of the first slot 213 determines the distance between a proximal-most and a distal-most position of the tip of the needle 270 during the operation and may be designed based upon requirements. In an embodiment, the length of the first slot 213 may range between 10 mm and 15 mm. In an example implementation, the length of the first slot 213 is 14 mm. The first slot 213 has a first end 213a disposed towards the first end 210a of the arm 210 and a second end 213b disposed towards the second end 210b of the arm 210. The first slot 213 is coupled with the slider 250 and facilitates in converting the oscillatory motion of the arm 210 into a linear motion of the needle 270.
[0040] The second slot 215 is provide at a distance from the first slot 213 towards the second end 210b of arm 210. The second slot 215 is longitudinally aligned with the first slot 213. In an embodiment, the second slot 215 has a rectangular shape with smooth edges. The second slot 215 may have a predefined length. The length of the second slot 215 may range between 18 mm and 20 mm. In an embodiment, the length of the of the second slot 215 is 19 mm. The second slot 215 has a first end 215a disposed towards the first end 210a of the arm 210 and a second end 215b disposed towards the second end 210b of the arm 210. The second slot 215 is configured to receive the peg 234 of the driver 230 providing a coupling between the driver 230 and the arm 210. The peg 234 is slidably disposed in the second slot 215 and is configured to slide within the second slot 215 between the first end 215a and the second end 215b in response to the rotation of the driver 230, causing the arm 210 to oscillate about the pivot point. The width of the second slot 215 corresponds to the diameter of the peg 234.
[0041] Fig. 2d depicts the needle 270 and the slider 250, according to an embodiment. The needle 270 is disposed within the first lumen of dilator 110 and is configured to pierce a target site, e.g., the septum. The needle 270 has a proximal end 270a and a distal end 270b. The needle 270 has an elongated structure. The needle 270 may feature a solid interior or a hollow interior defining at least one lumen. In the depicted embodiment, the needle 270 has a tubular structure including a lumen extending along the length, configured to accommodate and provide a passage to a guidewire (not shown). The diameter of the lumen may be designed according to the diameter of the guidewire. The needle 270 may include one or more additional lumens. In an embodiment, the needle 270 is made from a medical grade material, for example, stainless steel (e.g., SS304).
[0042] In an embodiment, the needle 270 includes a proximal section 271 towards the proximal end 270a and a distal section 273 towards the distal end 270b of the needle 270. In an embodiment, the outer diameter of the distal section 273 of the needle 270 is smaller than the outer diameter of the proximal section 271 of the needle 270. This provides enough stability to the needle 270 during its longitudinal movement, while ensuring that a portion of the needle 270 inside a patient’s body can be made as small as possible to prevent trauma. In another embodiment, the proximal section 271 and the distal section 273 have the same diameter. The distal section 273 is slidably disposed with in the first lumen of the dilator 110. The outer diameter of the distal section 273 is less than or equal to the diameter of the first lumen of the dilator 110 and is chosen based upon procedural requirements. In an embodiment, the outer diameter of the distal section 273 of the needle 270 ranges from 0.8 mm to 1.2 mm. In an example implementation, the outer diameter of the distal section 273 of the needle 270 is 1.06 mm. At least a portion of the proximal section 271 is slidably disposed within the second cavity 133 of the first tubular portion 131a of the handle 130. The outer diameter of the proximal section 271 ranges from 0.8 mm to 1.3 mm. In an embodiment, the outer diameter of the proximal section 271 is 1.2mm. The needle 270 includes a tip 273a provided at the distal end 270b. The tip 273a of the needle 270 is configured to puncture a target site or a target area, such as the septum of a patient. In an embodiment, the tip 273a has a bevel or tapered structure to facilitate penetration through the septum more easily.
[0043] The slider 250 is coupled to the needle 270. The slider 250 may be detachably or fixedly coupled to the needle 270 using any suitable coupling techniques. In an embodiment, the slider 250 is integrally coupled (i.e., forms an integrated structure) with the needle 270 as depicted in Fig. 2d. In other words, the needle 270 and the slider 250 form an integrated structure. The slider 250 facilitates the conversion of the rotational movement of the actuator 150 into the linear movement of the needle 270. The position of the slider 250 is chosen such that the movement of the slider 250 actuates a required length of the needle 270 for piercing. In an embodiment, the slider 250 is positioned at the intersection of the distal section 273 and the proximal section 271. In an embodiment, the slider 250 is made from stainless steel (e.g., SS304) though it may be made of any other suitable material. In an embodiment, the slider 250 has a cuboidal shape. It is possible that the slider 250 may have any other shape. The slider 250 includes a peg 251 extending away from a lateral face of the slider 250. The peg 251 may be integrally coupled (e.g., extruded) with the slider 250 or may be a separate component coupled to the slider 250 using, for example, welded, bonded, screwed, etc. The peg 251 is coupled with the arm 210. In an embodiment, the peg 251 is slidably disposed within the first slot 213. The width of the first slot 213 corresponds to the diameter of the peg 251. The peg 251 is configured to slide within the first slot 213 between the first end 213a and the second end 213b of the first slot 213 in response to the angular (or oscillatory) motion of the arm 210. The coupling between the peg 251 and the first slot 213 converts the angular motion of the arm 210 to a longitudinal (or linear) motion of the needle 270, causing the slider 250 and the needle 270 to move linearly.
[0044] The working of the actuating assembly to move the needle 270 is now explained with reference to Figs. 3a, 3b and 3c. Fig. 3a depicts a first (or default) position of the instrument 100. In a default position, the tip 273a resides inside the dilator 110 and is proximal to the distal end 110b of the dilator 110 by a pre-defined distance. This prevents any unwanted damage to the vasculature or surrounding tissues during the navigation of the dilator 110. In an embodiment, the pre-defined distance may be between 3 mm and 4 mm. Further, the peg 234 of the driver 230 is disposed at the second end 215b of the second slot 215 and the peg 251 of the slider 250 is disposed substantially at the center of the first slot 213. When the actuator 150 is rotated in a pre-defined direction, e.g., the anti-clock wise direction in the depicted embodiment, causing the driver 230 to rotate in the same direction. The coupling of the peg 234 of the driver 230 with the second slot 215 causes the arm 210 to move angularly in a forward (i.e., distal) direction and the peg 234 to slide within the second slot 215 towards the first end 215a of the second slot 215. Further, the peg 251 moves in the first slot 213 towards the second end 213b of the first slot 213. This results in the slider 250 to move linearly in the forward direction, causing the needle 270 to move linearly in the forward direction. Consequently, the tip 273a protrudes out of the dilator 110 and pierces the septum, leading to a puncture in the septum. When the actuator 150 is rotated by a first predefined angle (e.g., 90 degrees) in the pre-defined direction (representing an actuation position of the actuator 150), the needle 270 moves form the default position to the distal-most position (or the actuated position, interchangeably referred to as actuation position) as depicted in Fig. 3b and the actuation assembly is at the actuation position. At the actuation position, the arm 210 is at its forward-most position (in an arc traversed by the arm 210) and the peg 234 is disposed substantially at the center of the second slot 215, the peg 251 is disposed between a center and the second end 213b of the first slot 213, and the tip 273a of the needle 270 extends out of the dilator 110.
[0045] When the actuator 150 is rotated further by a second predefined angle in the pre-defined direction, the peg 234 moves further towards the first end 215a of the second slot 215. This causes the arm 210 to move angularly in the backward (i.e., proximal direction). This results in the peg 251 of the slider 250 moving towards the first end 213a of the first slot 213, causing the slider 250 and the needle 270 to move linearly in the backward direction. Consequently, the tip 273a retreats. Upon the subsequent rotation of the actuator 150 by a second pre-defined angle, for example, 90 degrees, in the predefined direction from the actuation position of the actuator 150 (i.e., 180 degrees from the default position), the peg 234 is at the first end 215a of the second slot 215, the peg 251 is at the center of the first slot 213 and the tip 273a is at the pre-defined distance proximal to the distal end 110b of the dilator 110. Thus, the rotation of the actuator 150 by the second pre-defined angle in the pre-defined direction from its actuation position, the needle 270 moves from the actuated position to the default position.
[0046] As the actuator 150 is rotated further, the arm 210, the slider 250 and the needle 270 continue to move backwards. When the actuator 150 is rotated by another 90 degrees in the pre-defined direction (i.e., 270 degrees from the default position), the needle 270 (and the tip 273a) is at the proximal-most position. Further, the arm 210 is at the backward-most position, the peg 234 is disposed substantially at the center of the second slot 215, and the peg 251 is disposed between the center and the first end 213a of the first slot 213 as depicted in Fig. 3c. When the actuator 150 is rotated further, the arm 210, the slider 250 and the needle 270 move forward in a similar manner. When the actuator 150 is rotated by one full rotation (i.e., by 360 degrees), the instrument 100 and various component of the actuating assembly reach the respective default positions.
[0047] Thus, the rotation of the actuator 150 causes the arm 210 to perform oscillatory (or angular) motion between the forward-most and the backward-most positions, and the coupling of the peg 251 with the arm 210 causes the slider 250 and the needle 270 to move linearly correspondingly. The forward movement of the needle 270 from the default position to the distal-most position (or actuated position) results in puncturing the septum. The driver 230, the peg 234, the arm 210, the peg 251 and the slider 250 work in sync to ensure that the return stroke of the needle 270 is faster than the forwards stroke of the needle 270. In other words, the actuating assembly provides a quick-return movement of the needle 270, thereby preventing damage to surrounding tissues.
[0048] Fig. 4 illustrates a flowchart of a method 400 of operating the instrument 100 according to an embodiment. The instrument 100 is used to puncture the targeted site such as a septum of the patient. The method 400 may be performed under fluoroscopic guidance or any other imaging guidance technique.
[0049] At step 401, the dilator 110 is inserted into a patient’s body via an appropriate vascular access point, e.g., through the transfemoral vein of the patient. Further, a guidewire (not shown) is inserted into the lumen of the needle 270 via the first port 132 of the handle 130. In an example implementation, the guidewire may have a J-shaped tip to prevent trauma to the vasculature during the navigation of the dilator 110.
[0050] At step 402, the dilator 110 is navigated through the patient’s vasculature to a target site over the guidewire. The navigation may be performed with the help of imaging guidance techniques. At this stage the needle 270 remains at the default position or inside the dilator 110. The tip 273a of the needle 270 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.
[0051] At step 403, once the dilator 110 is positioned at the target site (such as septum), the needle 270 is advanced to puncture the target site (e.g., the septum) using the actuating assembly. For example, the actuator 150 is rotated in the pre-defined direction by one rotation to cause the needle 270 to undergo a reciprocating motion as explained earlier and puncture the septum. Due to the quick-return mechanism of the instrument 100, the needle 270 retreats within the dilator 110 quickly. Before advancing the needle 270, the guidewire is withdrawn into the dilator 110. This is done so that the guidewire does not obstruct the path of the needle 570 during the puncture.
[0052] At step 404, the dilator 110 is withdrawn from the patient’s body.
[0053] Figs. 5 and 5a show an instrument 500 for puncturing the transseptal wall, according to another embodiment of the present disclosure. The instrument 500 has a proximal end 500a and a distal end 500b. The instrument 500 includes a dilator 510, a needle 570, a handle 530, and an actuating assembly.
[0054] The dilator 510 is located towards the distal end 500b of the instrument 500. The dilator 510 has a proximal end 510a and a distal end 510b. The dilator 510 is structurally and functionally similar the dilator 110 of the instrument 100, except that the dilator 510 includes two lumens namely, a first lumen 511 and a second lumen 513, and includes serrations 512 provided on an outer surface of the dilator 510 for at least a partial length of the dilator 510. The first lumen 511 and the second lumen 513 extend for the entire length of the dilator 510. In an embodiment, the first lumen 511 is configured to receive the needle 550. The second lumen 513 is configured to provide a passage to a guidewire 10 as shown in Fig. 5a. In an embodiment, the guidewire 10 have a J-shaped distal tip 10a. This minimizes trauma to the surrounding tissues during the navigation of the dilator 510 and the operation of the needle 570. The function of the dilator 510 can be referred from the dilator 110 of the instrument 100 and is not repeated for the sake of brevity. The dilator 510 is coupled to the handle 530 at the proximal end 510a of the dilator 510 in a similar manner as described in conjunction with the dilator 110.
[0055] The handle 530 is disposed at the proximal end 500a of the instrument 500. The structure and function of the handle 530 can be referred from the handle 130 of the instrument 100 and is not repeated for the sake of brevity.
[0056] The instrument 500 includes an actuating assembly for imparting a linear motion to the needle 550. In an embodiment, the actuating assembly of the instrument 500 includes an actuator 550, a driver, an arm and a slider. The structure and function of the actuator 550, the driver, the arm, and the slider of the instrument 500 can be referred from the actuator 150, the driver 230, the arm 210, and the slider 250 respectively, of the instrument 100 and is not repeated for the sake of brevity.
[0057] The needle 570 is configured to pierce a target site, e.g., the septum. The function and structure of the needle 570 of instrument 500 may be referred from the structure and function of the needle 270 of the instrument 100 and is not repeated for the sake of brevity. In an embodiment, the needle 570 may have a solid or hollow interior structure (with or without a lumen).
[0058] The instrument 500 may be operated using a method similar to the method 400 and is not repeated for the sake of brevity.
[0059] The instrument of the present disclosure offers several advantages over conventional instruments. Unlike conventional instruments having a separate dilator and a needle, the present instrument integrates the dilator and the needle into a single unit. Therefore, the present instrument decreases the number of instruments needed for a procedure and reduces procedural complexity. Further, the proposed instrument eliminates the need to switching between multiple components, thereby, reducing the overall procedure time. The present instrument provides a quick return mechanism that offers precise motion to the needle for accurate puncture of the septum of the heart. The quick return of the needle within the dilator reduces the chances of damage to the surrounding tissue of the septum, increasing the safety of the instrument. The instrument, thus, increases the overall efficiency of the procedure, and improves procedural outcomes.
[0060] 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. , C , Claims:WE CLAIM
1. An instrument (100) for puncturing a septum wall, the instrument (100) comprising:
a. a handle (130);
b. a dilator (110) coupled to the handle (130) at a proximal end (110a) of the dilator (110), the dilator (110) comprising a first lumen;
c. a needle (270) disposed within the first lumen of the dilator (110), the needle (270) comprises a tip (273a) provided at a distal end (270b) and configured to puncture the septal wall; and
d. an actuating assembly coupled to the needle (270) and configured to drive the needle (270) in a longitudinal direction, the actuation assembly comprising:
i. an actuator (150) coupled to the handle (130) and configured to rotate about an axis;
ii. a driver (230) coupled to the actuator (150) and configured to rotate in response to the rotation of the actuator (150), the driver (230) comprising a peg (234);
iii. an arm (210) coupled to the driver (230) and pivotably coupled to the handle (130), the arm (210) configured to oscillate about a pivot point in response to the rotation of the driver (230), the arm (210) comprising a first slot (213) and a second slot (215) ; and
iv. a slider (250) coupled to the needle (270), the slider (250) comprising a peg (251);
e. wherein the peg (234) of the driver (230) is slidably disposed within the second slot (215) of the arm (210) and the peg (251) of the slider (250) is slidably disposed within the first slot (213) of the arm (210);
f. wherein in response to the rotation of the actuator (150), the peg (234) of the driver (230) is configured to slide within the second slot (215), causing the arm (210) to oscillate about the pivot point; and
g. wherein in response to the oscillatory motion of the arm (210), the peg (251) of the slider (250) is configured to slide within the first slot (213), causing the slider (250) and the needle (270) to move linearly.
2. The instrument (100) as claimed in claim 1, wherein the arm (210) comprises a pin (211) at the first end (210a) of the arm (210), the pin (211) is pivotably coupled within an aperture (134) provided in the handle (130), thereby forming the pivot point.
3. The instrument (100) as claimed in claim 1, wherein the peg (234) of the driver (230) is positioned eccentrically on the driver (230).
4. The instrument (100) as claimed in claim 1, wherein the needle (270) comprises a proximal section (271) slidably disposed within a first tubular portion (131a) of the handle (130) and a distal section (273) slidably disposed within the first lumen of the dilator 110.
5. The instrument (100) as claimed in claim 4, wherein the slider (250) is coupled to the needle (270) at an intersection of the distal section (273) and the proximal section (271) of the needle (270).
6. The instrument (100) as claimed in claim 1, wherein the needle (270) comprises a lumen extending along the length of the needle (270) and configured to accommodate a guidewire.
7. The instrument (100) as claimed in claim 1, wherein the actuator (150) comprises a projection (152) extending through an aperture of the handle (130) and coupled with an opening (232) provided in the driver (230).
8. The instrument (100) as claimed in claim 1, wherein the instrument (100) comprises a conducting element (135a) wound on an outer surface of the proximal section (271) of the needle (270) and coupled to an RF generator, the conducting element (135a) is configured to transfer an RF excitation signal receiving from the RF generator to the needle (270).
9. The instrument (100) as claimed in claim 1, wherein the dilator (110) comprises serrations on an outer surface of the dilator (110).
10. The instrument (100) as claimed in claim 1, wherein rotating the actuator (150) by a first pre-defined angle in a pre-defined direction from a default position of the actuator (150) causes the needle (270) to advance from a default position to an actuated position, wherein in the actuated position of the needle (270), the tip (273a) of the needle (270) extends out of a distal end (110b) of the dilator (110), the peg (234) of the driver (230) is substantially at a center of the second slot (215).
11. The instrument (100) as claimed in claim 10 wherein subsequent rotation of the actuator (150) in the pre-defined direction by a second pre-defined angle, causes the tip 273a of the needle (270) to retract from the actuated position to the default position, wherein in the default position of the needle (270), the tip (273a) of the needle (270) resides within the dilator (110) at a predefined distance from the distal end (110b) of the dilator (110), the peg (234) of the driver (230) is at a first end (215a) of the second slot (215), and the peg (251) of the slider (250) is substantially at a center of the first slot (213).
12. The instrument (100) as claimed in claim 10, wherein the actuator (150) comprises one or more markings (160) indicating the pre-defined direction of the actuator (150).
13. The instrument (100) as claimed in claim 1, wherein the dilator (510) comprises a second lumen (513) configured to receive a guidewire (10).
14. An actuating assembly for actuating a needle (270) to puncture a transeptal wall, the actuating assembly comprising;
a. an actuator (150) coupled to a handle and configured to rotate about an axis;
b. a driver (230) coupled to the actuator (150) and configured to rotate in response to the rotation of the actuator (150), the driver (230) comprising a peg (234);
c. an arm (210) coupled to the driver (230) and pivotably coupled to the handle (130), the arm (210) configured to oscillate about a pivot point in response to the rotation of the driver (230), the arm (210) comprising a first slot (213) and a second slot (215); and
d. a slider (250) coupled to the needle (270), the slider (250) comprising a peg (251);
e. wherein the peg (234) of the driver (230) is slidably disposed within the second slot (215) of the arm (210) and the peg (251) of the slider (250) is slidably disposed within the first slot (213) of the arm (210);
f. wherein in response to the rotation of the actuator (150), the peg (234) of the driver (230) is configured to slide within the second slot (215), causing the arm (210) to oscillate about the pivot point; and
g. wherein in response to the oscillatory motion of the arm (210), the peg (251) of the slider (250) is configured to slide within the first slot (213), causing the slider (250) and the needle (270) to move linearly.