Surgical device with two-hole suture needle, needle driving mechanism, optical imaging, and disposable needle cartridge

Abstract

A surgical device includes a distal end assembly having a needle driving mechanism for driving a suture needle along a circular path through an arm having a needle engaging end, and driven to undergo a reciprocating circular movement of 180 degrees. An engaging-disengaging mechanism moves the arm perpendicular to the suture needle to engage or disengage the needle engaging end of the arm with the suture needle. The engaging-disengaging mechanism and the needle driving mechanism work in a predefined sequence to cause the suture needle to move by a complete 360 degrees revolution in two stages of 180 degrees each to complete a suturing cycle. The suture needle has two holes near two ends where the needle engaging end of the arm engages / disengages. A disposable suture needle cartridge is also provided that is the only disposable part of the device.

Description

SURGICAL DEVICE WITH TWO-HOLE SUTURE NEEDLE, NEEDLE DRIVING MECHANISM, OPTICAL IMAGING, AND DISPOSABLE NEEDLE CARTRIDGETECHNICAL FIELD

[0001] The present disclosure relates to the field of surgical instruments. In particular, it pertains to suturing device. Specifically, it pertains to a suture needle and a needle driving mechanism for driving the suture needle, which can be universally adapted for use across all types of surgical procedures including open surgeries, minimally invasive surgeries (MIS) such as laparoscopy, arthroscopy, and endoluminal surgeries, as well as robotic -assisted surgeries.BACKGROUND

[0002] The background description includes information that may be useful in understanding the present disclosure. It is not an admission that any of the information provided herein is prior art or relevant to the present disclosure.

[0003] Minimally invasive surgery (MIS) has revolutionized the field by enabling procedures with smaller incisions and faster recovery. However, despite advancements in surgical techniques, suturing and knotting during MIS remain a significant challenge due to the complexity of manipulating needles in confined spaces with limited visualization and restricted degrees of freedom.

[0004] Conventional suture needles used in surgical procedures, whether for open or minimally invasive surgery, are solid-body arc-shaped needles with a single hole (swage or drilled eye) at one end for attaching suture thread. These needles are gripped by needle holders / drivers and manually driven through tissue by the surgeon’s wrist motion.

[0005] Conventional suturing instruments / devices for minimally invasive surgery face limitations including difficulty in needle replacement during surgery, risk of needle slippage, confinement of the needle within enclosed housing tracks, inability to adapt driving force to different tissue types and thicknesses, limited adaptability of the needle and driving mechanism across different surgical platforms including open surgery, minimally invasive surgery, and robotic surgery, and risk of needle stick injuries to surgical staff during manual needle handling. Furthermore, all known mechanical suturing devices operate with fixed, non-adaptive driving force providing the same force regardless of tissue type or thickness. This one-size-fits-all approach leads to excessive force on delicate tissues (causing tearing, suture pull-through, and potential anastomotic leak) and insufficient force on dense tissues (causing incomplete penetration requiring multiple attempts with cumulative tissue damage).

[0006] Therefore, there exists a need for an improved suture needle design and driving mechanism that addresses the above limitations, have an integrated optical imaging module and Al-powered computer vision for enhanced surgical site visualization along with a device architecture that is universally adaptable across all types of surgical procedures and that provides a cost-effective hybrid approach to disposability and reusability.OBJECTS OF THE INVENTION

[0007] A primary object is to provide a suture needle of the present disclosure having two holes passing entirely through the cross-section of the needle body, enabling positive mechanical coupling with a driving mechanism via pin- hole engagement. The suture needle may be provided with different types of end tips including taper point, taper cut, reverse cutting, and conventional cutting tip profdes, and with different body cross-sections including round body, square body, and reverse cutting body profdes, to accommodate different tissue types and surgical requirements. The suture needle has suture material attached at or near its blunt end and is compatible with all standard suture materials including absorbable and nonabsorbable suture materials.

[0008] Another object is to provide a needle driving mechanism utilizing a driving gear arrangement wherein a grasper pin on an arm passes through a hole of the suture needle for positive coupling, and the arm traverses a parallelogram motion path to drive the needle in a circular arc, with a separate lead screw-based engagement and disengagement mechanism for selectively coupling and decoupling the arm pin from the needle holes at different stages of the suturing cycle.

[0009] Another object is to provide a universal suture needle and driving mechanism platform that can be adapted and integrated into surgical devices for all types of surgical procedures including open surgery, minimally invasive surgery, and robotic -assisted surgery.

[0010] Another object is to provide a disposable suture needle cartridge comprising a two-part design with a main cartridge containing the suture needle with pre-attached suture material and a cartridge body containing pre-wrapped suture thread with a breaking zone, such that after loading the cartridge into the reusable device, the cartridge body is snapped off and discarded while the main cartridge with needle remains secured in the device, and the entire device including the driving assembly, sensors, optical imaging module, controller, and handle is fully reusable.

[0011] Another object is to provide a reusable device wherein electronic components including controller, sensors, and motor driver are encapsulated using epoxy potting for protection against sterilization processes, and a detachable rechargeable battery system enables easy battery replacement and charging without compromising the sealed electronics. A knuckle joint connects the shaft and the distal end of the device such that it can do pitch movement (up and down articulation).

[0012] Another object is to provide a smart surgical device incorporating the suture needle and driving mechanism with sensor-based tissue characterization and Al-powered adaptive force modulation for optimized suturing outcomes.

[0013] Another object is to provide an integrated optical imaging module at the distal end of the device, comprising a miniature camera sensor with LED illumination, configured to capture real-time images and video of the surgical site during suturing for enhanced visualization by the surgeon.

[0014] Another object is to provide Al-powered computer vision capabilities that process image data from the optical imaging module for automated tissue boundary detection, wound edge identification, real-time needle tracking, suturing path optimization, and tissue type classification.

[0015] Another object is to prevent needle stick injuries to surgical staff by providing a device wherein the suture needle is loaded via a cartridge system without manual needle handling, driven mechanically through tissue without manual manipulation, and remains positively engaged with the device at all times via the arm pin through the holes, thereby minimizing direct contact between surgical staff and the sharp needle point throughout the surgical procedure.SUMMARY OF THE INVENTION

[0016] Aspects of the present disclosure relate to a surgical device (also referred to simply as device herein) comprising a novel needle driving mechanism, a disposable suture needle cartridge (also referred to simply as cartridge herein) and a suture needle (also referred to simply as needle herein) thereof. In an aspect, the needle driving mechanism of the device works by engaging and disengaging with two holes provide in a needle body of the suture needle.

[0017] In an aspect, the disclosed surgical device for performing suturing procedures includes a distal end assembly that includes a needle driving mechanism for driving a suture needle along a circular path, and an engaging-disengaging mechanism. The needle driving mechanismincludes an arm having a needle engaging end (also referred to as distal end, herein), and is driven such that the needle engaging end of the arm undergoes a reciprocating circular movement between a first end and a second end that is spaced apart from the first end by 180 degrees. The engaging-disengaging mechanism is coupled to the arm to move the arm perpendicular to a plane of the circular path of the suture needle such that moving the arm towards the suture needle results in the needle engaging end of the arm engaging with the suture needle, and moving the arm away from the suture needle results in the needle engaging end of the arm disengaging from the suture needle.

[0018] In an aspect, the engaging -disengaging mechanism and the needle driving mechanism are configured to work in a predefined sequence to cause the suture needle to move by a complete 360 degrees revolution in two stages of 180 degrees each to complete a suturing cycle.

[0019] In one or more embodiments, the surgical device may include a disposable suture needle cartridge configured to accommodate the circular arc-shaped suture needle for movement along the circular path. The suture needle cartridge may be configured for a detachable coupling to a distal end of the distal end assembly. Further, the surgical device may be characterized by the disposable suture needle cartridge being the only disposable component of the surgical device.

[0020] In one or more embodiments, the predefined sequence of working of the engaging-disengaging mechanism and the needle driving mechanism may include the steps of: (i) engaging the needle engaging end of the arm with the suture needle close to the blunt side end of the suture needle, (ii) driving the suture needle along the circular path by 180 degrees; (iii) disengaging the needle engaging end of the arm from the suture needle; (iv) moving the arm back to starting position without the arm being in engagement with the suture needle; (v) engaging the needle engaging end of the arm with the suture needle close to the pointed end of the suture needle; (vi) driving the suture needle along the circular path by another 180 degrees to complete a full 360 degrees revolution of suture needle along the circular path. The sequence may further comprise the step of (vii) disengaging the needle engaging end of the arm with the suture needle and moving the arm back to starting position without the arm being in engagement with the suture needle for repeating the sequence for another full 360 degrees revolution of suture needle along the circular path.

[0021] In one or more embodiments, the arm may include a needle grasping pin located at the needle engaging end of the arm, and the suture needle comprises a first hole (also referred to a pointed end side hole, herein) proximate to the pointed end of the suture needle, and asecond hole (also referred to a blunt end side hole, herein) proximate to the blunt end of the suture needle and spaced apart from the first hole by 180 degrees such that when the arm is moved towards the suture needle the needle grasping pin engages with the first hole or the second hole to drive the suture needle, and when the arm is moved away from the suture needle the needle grasping pin disengages from the first hole or the second hole to allow the arm to undergo circular movement without driving the suture needle.

[0022] In one or more embodiments, the needle driving mechanism may include a driving gear with a proximal end of the arm pivotally fixed to the driving gear at a predefined radius such that, when the driving gear undergoes rotation, the proximal end of the arm undergoes a circular movement. The needle driving mechanism further includes a driven gear in mesh with the driving gear for rotation when the driving gear undergoes rotation. A sliding block is pivotally fixed to the driving gear the predefined radius and is in sliding engagement with a longitudinal slot in the arm. The predefined radius is equal to a radius of the circular path of the suture needle such that when the driven gear is reciprocatingly rotated by 180 degrees, in the first direction (also referred to as clockwise direction) and the second direction (also referred to as anti-clockwise direction) opposite the first direction, the needle engaging end of the arm undergoes the reciprocating circular movement between the first end and the second end that is spaced apart from the first end by 180 degrees.

[0023] In one or more embodiments, the driving gear may include a gear portion and a pulley portion with a cable hole for attachment of two cables with crimps for enabling rotation of the driving gear in the first direction and the second direction.

[0024] In one or more embodiments, the engaging disengaging mechanism may include a lead screw in a threaded engagement with the arm such that rotation of the lead screw in a first direction causes the arm to move towards the suture needle, and rotation of the lead screw in a second direction opposite the first direction causes the arm to move away from the suture needle.

[0025] In one or more embodiments, the device comprises a handle accommodating a first motor (also referred to as motor 1, herein) coupled to the driving gear of the needle driving mechanism through first cable such that rotation of the first motor in a first direction and a second direction opposite the first direction results in the reciprocating circular movement of the arm.

[0026] The handle can further have a second motor (also referred to as motor 2, herein) coupled, through second cables, to a pulley that may be fixed to the lead screw of the of the engaging-disengaging mechanism such that rotation of the second motor in a first direction ora second direction opposite the first direction results in moving the arm towards or away from the suture needle.

[0027] In one or more embodiments, the handle may include an engagement-disengagement button located that is operatively coupled to the second motor such that actuation of the engagement-disengagement button rotates the second motor in the first direction to engage the arm with the suture needle after a detachable suture needle cartridge accommodating the suture needle is attached to the distal end assembly, or rotates the second motor in the second direction to disengage the arm from suture needle when the detachable suture needle cartridge is to be detached from the distal end assembly.

[0028] In one or more embodiments, the handle may include a flush port for flushing internal channels of the surgical device with a cleaning solution after surgery.

[0029] In one or more embodiments, the device may include a camera, one or more sensors and LED illumination elements located on the distal end assembly to sense and view tissues being sutured, wherein the camera. The one or more sensors and the LED illumination elements are operatively coupled to an electronic circuit located in the handle.

[0030] In one or more embodiments, the electronic circuit may include : electric drives for the first motor and the second motor, a controller incorporating a machine learning inference engine and a computer vision processing module; wherein the electronic circuit and its electronic components are encapsulated in a sealed enclosure by an epoxy potting compound to facilitate autoclave, gamma, ETO sterilization of the handle; wherein the epoxy potting compound protects the electronic components from damage during sterilization.

[0031] In one or more embodiments, the controller may be configured to sequentially activate the first motor and the second motor for the suturing cycle.

[0032] In one or more embodiments, the controller may be configured to dynamically adjusts torque of the first motor to deliver a tissue-specific needle penetration force calculated by the machine learning inference engine based on tissue thickness and density measured by the sensors, such that the penetration force is automatically reduced for thin delicate tissues and automatically increased for thick dense tissues.

[0033] In one or more embodiments, the handle may include a main trigger operatively coupled to the controller such that pressing the main trigger activates the suture cycle.

[0034] In one or more embodiments, the surgical device may include a rechargeable battery detachably located in the handle to provide power to the first motor and the second motor and the electronic circuit.

[0035] In one or more embodiments, the controller may include a computer vision processing module for processing image data from the camera for at least one of tissue boundary detection, wound edge identification, real-time needle tracking, suturing path optimization, and stitch quality assessment.

[0036] In one or more embodiments, the controller may also include a depth-sensing module for three-dimensional tissue surface mapping based on a light projector and a time-of-flight sensor.

[0037] In one or more embodiments, the electronic circuit may include a wireless communication module for transmitting one or more of image data, sensor data, and operational parameters to at least one of an external display for surgical visualization, a cloud-based analytics platform, robotic surgery integration, loT applications, remote monitoring and a remote telementoring system.

[0038] In one or more embodiments, the surgical device may be adapted for minimally invasive surgery, and comprises a shaft coupled to a distal end of the handle, and a knuckle joint coupled between a distal end of the shaft and the distal end assembly; wherein the knuckle joint is a pin-connected joint enabling up to 85 degrees of pitch articulation of the distal end assembly.

[0039] In one or more embodiments, the device may further include a roticulation wheel on the handle providing plus or minus 180 degrees of axial rotation of the shaft and distal end assembly with ball plunger positional locking, and a ball plunger articulation locking mechanism for locking the pitch angle at any desired position

[0040] In one or more embodiments, the surgical device may be adapted for robotic surgery; wherein the needle driving mechanism and the engagement-disengagement mechanism are actuated by a robotic arm through cables or direct mechanical coupling.

[0041] In one or more embodiments, the surgical device is adapted for endoscopic and endoluminal surgery; and comprises a flexible shaft coupled between the distal end assembly and a distal end of the handle.

[0042] In one or more embodiments, the surgical device is adapted for open surgery; wherein the distal end assembly is coupled to a handheld instrument,

[0043] An aspect of the present disclosure relates to a suture needle for surgical suturing procedures, which includes: an arc-shaped needle body having a pointed end and a blunt end with suture material attached at or near the blunt end; a first through hole provided on the needle body proximate to the pointed end, and a second hole provided on the needle body proximate to the blunt end; wherein the first and second holes are configured to receive an armpin of a needle driving mechanism for positive mechanical coupling at different stages of a suturing cycle, and wherein an outer circumferential surface of the needle body between the first and second holes is free of surface notches, recesses, and indentations, presenting a smooth, uninterrupted profile for an atraumatic passage through tissue.

[0044] In one or more embodiments, the needle body may have a cross-sectional profile selected from round body and square body; the pointed end has a tip profile selected from taper point, taper cut, reverse cutting, and conventional cutting; and the suture material is selected from absorbable suture materials, non-absorbable suture materials, and barbed suture materials.

[0045] While the preferred embodiment describes holes that extend entirely through the cross-section of the needle body defining cylindrical apertures, in alternative embodiments the holes in the needle body may be of any suitable configuration including, but not limited to, through-holes extending entirely through the needle body, blind holes extending partially into the needle body from one side, tapered holes, countersunk holes, or slots, provided that the hole is configured to receive and positively engage with the needle grasping pin of the driving mechanism. The depth, diameter, and profile of the holes may be selected based on the needle size, the pin diameter, and the required engagement strength for the intended surgical application

[0046] Yet another aspect of the present disclosure relates to a disposable suture needle cartridge that includes: a main cartridge having a cartridge baseplate, a two-hole suture needle with pre-attached suture material, a top cover, and snaps provided on the cartridge base plate for securing the suture needle cartridge to a suturing device. The suture needle cartridge further includes a cartridge body having a thread wrapping area and a removal grip coupled to the cartridge baseplate at a breaking zone. The main cartridge is loaded into the suturing device by sliding the main cartridge into a cartridge slot of the suturing device, the snaps engaging at snap engagement features provided in the suturing device, upon which, the holes of the two-hole suture needle align with a profile in a baseplate of the suturing device to enable coupling of a needle grasping pin of a needle driving mechanism of the suturing device with the holes of the two-hole suture needle for driving the suture needle along a circular path. The cartridge body is snapped off at the breaking zone and discarded after insertion of the main cartridge has been loaded.

[0047] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying drawings are included to provide a further understanding of the present disclosure.

[0049] FIG. 1A illustrates an exemplary perspective view of the proposed surgical device, in accordance with an embodiment of the present disclosure.

[0050] FIG. IB illustrates an exemplary perspective view of the proposed surgical device with a suture needle cartridge of the device in the process of being coupled to a distal end assembly of the device, in accordance with one or more embodiments of the present disclosure.

[0051] FIG. 1C illustrates an exemplary closer view of a distal end of the device showing suture needle cartridge of the device in the process of being coupled to a distal end assembly of the device, in accordance with one or more embodiments of the present disclosure

[0052] FIG. ID illustrates an exemplary closer view of a distal end of the device showing camera and sensors provided on the distal end assembly, in accordance with one or more embodiments of the present disclosure.

[0053] FIG. IE illustrates an exemplary closer view of a distal end of the device showing articulation of the distal end assembly facilitated by a knuckle joint between a shaft and the distal end assembly, in accordance with one or more embodiments of the present disclosure

[0054] FIG. 2 illustrates a side view of handle of the device with its details, in accordance with one or more embodiments of the present disclosure.

[0055] FIG. 3 illustrates an exemplary exploded view of the distal end assembly of the device, in accordance with one or more embodiments of the present disclosure.

[0056] FIGs. 4A and 4B illustrates exemplary top and bottom views of the distal end assembly showing details thereof, in accordance with one or more embodiments of the present disclosure.

[0057] FIGs. 5A and 5B illustrate exemplary side views of the distal end assembly showing working of an engagement-disengagement mechanism of the device, in accordance with an embodiment of the present disclosure.

[0058] FIG. 6 illustrates an exemplary perspective view of an arm of the device that drives a suture needle, in accordance with one or more embodiments of the present disclosure.

[0059] FIG. 7 illustrates an exemplary side perspective view of a driving gear of the device that drives that arm, in accordance with one or more embodiments of the present disclosure.

[0060] FIGs. 8A and 8C illustrate different exemplary views of the suture needle cartridge of the device, in accordance with an embodiment of the present disclosure.

[0061] FIG. 9 illustrates an exemplary side view of the proposed suture needle, in accordance with one or more embodiments of the present disclosure.

[0062] FIG. 10 illustrates an exemplary electronic circuit of the device driving the needle driving mechanism and facilitating other functionalities of the device, in accordance with one or more embodiments of the present disclosure.

[0063] FIG. 11 illustrates an exemplary view of the proposed device configured for external suturing, in accordance with one or more embodiments of the present disclosure.

[0064] FIG. 12 illustrates an exemplary view of the proposed device configured for robotic surgery, in accordance with one or more embodiments of the present disclosure.

[0065] FIG. 13 illustrates an exemplary view of the proposed device configured for endoscopic surgery, in accordance with one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0066] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0067] Aspects of the present disclosure relate to a surgical device (also referred to simply as device herein) comprising a novel needle driving mechanism, a disposable suture needle cartridge (also referred to simply as cartridge herein) and a suture needle (also referred to simply as needle herein) thereof. In an aspect, the needle driving mechanism of the device works by engaging and disengaging with two holes provide in a needle body of the suture needle.

[0068] In an aspect, the present disclosure provides a suture needle having an arc-shaped body with a pointed end and a blunt end, the needle body includes a first hole (also referred to as pointed end side hole, herein) proximate to the pointed end, and a second hole (also referred to as blunt end side hole, herein) proximate to the blunt end, each hole defines a cylindrical aperture configured to receive an engagement element (needle engaging pin) of a needle driving mechanism for positive mechanical coupling. The suture needle has suture material attached at or near the blunt end. The suture needle is compatible with all standard suture materials including absorbable suture materials as well as non-absorbable suture materials

[0069] In another aspect, the present disclosure provides a needle driving device (also referred to as distal end assembly, hereon) for the surgical device that includes a needle driving mechanism and an engagement-disengagement mechanism, The needle driving mechanism includes: a driving gear driven by a first motor, such as through cables; a driven gear; an arm having a needle grasping pin and a slot, and an attachment end, wherein the slot receives a sliding block that is pivotally fixed to the driving gear, The attachment end of the arm is pivotally connected to the driven gear. Each connection is at a predefined radius that defines radius of the arc shaped suture needle and radius of its circular path. Rotation of the driving gear, such as by the first motor, causes the arm to traverse a curvilinear motion, while remaining all the time parallel to a line joining pivot points of the two gears, driving the needle in a circular arc. The engagement-disengagement mechanism includes a lead screw driven by a second motor via cables, The lead screw is in engagement with the arm of the needle driving mechanism and moves the arm perpendicular to a plane of the suture needle, i.e., towards oraway from the suture needle for selective engagement or disengagement of the needle engaging pin of the arm with the holes of the needle at different stages of suturing cycle . Advantageously, the needle driving device / distal end assembly of the present disclosure can be integrated with different types of surgical devices, such as in a surgical device for minimally invasive / laparoscopic surgery by configuring the distal end assembly at a distal end of a shaft through a knuckle joint, or in surgical device for endoscopic surgeries by configuring the distal end assembly at a distal end of a flexible shaft, or in a surgical device for robotic surgery by configuring the distal end assembly at a distal end of robotic arm, or in a surgical device for open surgery by configuring the distal end assembly at a distal end of a hand held surgical device.

[0070] In a still another aspect, the present disclosure provides a smart surgical device that is entirely reusable, comprising: the distal end assembly having a base plate with the needle driving and engagement-disengagement mechanisms mounted thereon and having covers to close the assembly from below and top. An optical imaging module and sensors are also mounted on the baseplate for real-time surgical site visualization and tissue characterization. A knuckle joint may connect a shaft to the distal end assembly, such as for configuring a surgical device for minimally invasive surgery, enabling pitch articulation up to 85 degrees with ball plunger positional locking. A handle with a roticulation wheel may be provided for plus or minus 180 degrees axial rotation (total 360 degree range) with ball plunger positional locking. The handle can further include an articulation wheel, a main trigger, an engagement / disengagement button, a flush port, the two motors with routing pulleys, epoxypotted electronics with AI / ML and computer vision capabilities, and a detachable rechargeable battery.

[0071] In a yet still another aspect, the present disclosure provides a disposable two-part suture needle cartridge comprising a suture needle with pre-attached suture material. The suture needle cartridge is the only disposable component of the disclosed device.

[0072] In another aspect, the surgical device of the present disclosure includes an integrated optical imaging module for real-time surgical site visualization, sensor-based tissue feedback, and Al-powered computer vision and force modulation, wherein the reusable device comprises a disposable suture needle cartridge which attaches at its distal end and which comprises only the suture needle with attached suture material, while the remainder of the device including the needle driving assembly, sensors, optical imaging module, controller, and handle assembly with epoxy-potted electronics and detachable battery system are fully reusable across multiple surgical procedures.

[0073] Referring now of the accompanying figures, different aspects of the disclosure are described in details on the below paragraphs.

[0074] FIGs. 1A to IE disclose an embodiment of the proposed surgical device that is configured for minimally invasive surgery with a disposable suture needle cartridge 50 attached at the distal end. The device includes a distal end assembly 1, a shaft 3, a knuckle joint 2 provided between the shaft 3 and the distal end assembly 1 for pitch movement of the distal end assembly 1, and a handle 4, Referring to FIGs. 1A and 2, the handle includes a flush port 5, roticulation wheel 6, engagement / disengagement button 7, articulation wheel 8, main trigger 9, removable battery 10, epoxy-potted electronics 11, the first Motor 12 with a coupled pulley 14, the second Motor 13 with a coupled pulley 5, articulation locking mechanism 16, and routing pulleys 17.

[0075] FIGs, IB and 1C show the disposable suture needle cartridge 50 being assembled with the distal end assembly 1 by being inserted within a slot 32 of the distal end assembly 1.

[0076] FIG. ID shows a camera 61 and sensor arrangement comprising sensors 62-1 and 62-2 (collectively referred to as sensors 62, herein), provided on a distal end of the distal end assembly 1, which function as part of an optical imaging module and tissue sensor mechanism of the device.

[0077] FIG. IE shows the knuckle joint 2 enabling a pitch movement of the FIG. ID illustrates relative to the shaft 3.A. Two-Hole Suture Needle

[0078] The present disclosure introduces a fundamentally new suture needle design. As illustrated in FIG. 9, the suture needle 41b has an arc-shaped needle body 42 with a pointed end and a blunt end. Unlike all conventional suture needles that have solid bodies with at most a single eye at one end for thread attachment, the suture needle of the present disclosure comprises two holes comprising a first hole / pointed end side hole 42a proximate to the pointed end and a second hole / blunt end side hole 42b proximate to the blunt end.

[0079] Each hole may extend through the entire cross-section of the needle body 42 from one side to the other, defining a cylindrical aperture. The holes 42a and 42b are configured to receive a needle grasping pin 20c (also referred to as arm pin 20c, herein) (refer to FIGs. 5 A, 5B and 6) of an arm 20 the driving mechanism that engages through the holes 42a and 42b to create a positive, bilateral mechanical coupling with 360-degree bearing contact around a circumference of the arm pin 20c (also referred to as the needle grasping pin 20c herein, and the two terms are used interchangeably).

[0080] Suture material 43 is attached at or near the blunt end of the needle by conventional attachment methods such as swaging or crimping. The suture needle of the present disclosure is compatible with all standard suture materials including absorbable suture materials as well as non-absorbable suture materials.

[0081] The suture needle 41b of the present disclosure may be manufactured with a variety of end tip profdes and body cross-sections to accommodate the full range of surgical suturing requirements. The end tip profiles include: (a) taper point — a sharp, gradually tapering tip that pierces tissue by spreading the tissue fibres apart, minimizing tissue trauma, suited for soft tissues and viscera; (b) taper cut — a combination of a taper point with a cutting edge at the tip, suited for tougher tissues such as fascia and periosteum; (c) reverse cutting — a triangular cross-section tip with the cutting edge on the outer curvature, providing maximum strength and reducing suture pull-through risk, suited for skin and tough connective tissue; and (d) conventional cutting — a triangular tip with the cutting edge on the inner curvature. The body cross-sections include: (i) round body for delicate tissues; (ii) square body for dense fibrous tissue; and (iii) reverse cutting body for sustained cutting capability. In all variants, the two holes are present proximate to each end, maintaining the same positive pin to hole engagement functionality with the driving assembly.

[0082] The two- hole design of the suture needle provides the following advantages: (a) the pin-to-hole coupling provides positive bilateral engagement where the needle grasping pin cannot slip out laterally; (b) the holes enable the arm pin to engage from a direction perpendicular to a plane of the needle and disengage by withdrawing the arm pin in the opposite direction, allowing the needle to remain stationary in tissue while the arm returns for a second engagement with the needle to complete the suture cycle for a bite; (c) the arm pin engages different holes at different stages of the suturing cycle, the thread-side hole (second hole) for the first stage of 180 degrees circular movement during which the pointed end of the needle pierces the tissue being sutured, and the pointed-end side hole (first hole) for the second stage of the 180 degrees circular movement during which the needle comes out of the tissue leaving the suture material 43 through the pierced tissue, enabling a complete bite-and-retum cycle; (d) the outer circumferential surface of the needle body between the two holes is smooth and uninterrupted; and (e) the needle can be easily loaded and replaced via a disposable cartridge without manual needle handling, thereby preventing needle stick injuries.B. Distal End Assembly

[0083] As shown in FIG, 3, the distal end assembly 1 comprises a baseplate 23c with atop cover 23a and a bottom cover 23b. As shown in FIGs. ID, 4A and 4B, the distal end assembly1 accommodates components of the needle driving mechanism and the engagementdisengagement mechanism, and also includes a camera 61 and sensors 62 for the optical imaging module and tissue sensing. The baseplate 23c includes, at a distal end, a cartridge slot 32 where a disposable suture needle cartridge 50 slides in, and further includes snap features, such as the snap engagement features 34a, 34b, for securing the suture needle cartridge 50.

[0084] The needle driving mechanism and the engagement-disengagement mechanism are mounted on the base plate 23c and include a driving gear 26, a driven gear 27, a lead screw 25 with cable tracks 25a, 25b for clockwise and anticlockwise rotation. A circular through cutout 34 is provided in the baseplate as a space through which the needle grasping pin 20c moves during its circular driving motion, as can be seen in FIG. 4B. The through cutout 34 allows the needle grasping pin 20c pass through the base plate 23c from a bottom side to an upper side at baseplate profile 33, for engaging with holes of the suture needle.

[0085] FIG. 4B also shows circular cutouts 30a, 30b in the baseplate 23c, through which pins that couple the arm 20 to the driving gear 26 and the driven gear 27, pass from a bottom side to the upper side of the base plate 23 c.C. Needle Driving Mechanism and Engagement-Disengagement Mechanism — Dual Motor System

[0086] The arm 20 of the needle driving mechanism, as shown in FIG. 9, has three parts: (a) the needle grasping pin 20c at the distal end of the arm 20, which engages with the two holes in the needle for positive engagement; (b) a longitudinal slot 20b, which receives a sliding block the driving gear pin 26a of the driving gear 26; and (c) an attachment end 20a for connection to driven pin 27a of the driven gear 27.

[0087] The driving gear 26, as shown in FIGs 4A to 5B, is the driving element with a gear portion on its bottom having the driving gear pin 26a, and a cable hole 26c on the pulley portion where two cables with crimps attach for clockwise and anticlockwise rotation. The driven gear 27 functions to guide the movement of the arm through driven pin 27a and attachment point 27c.

[0088] The lead screw 25, as shown in FIG. 10, has cable tracks 25a, 25b for receiving cables that rotate it clockwise and anticlockwise. A slotted profde 31 is attached to the lead screw such that on rotating it clockwise and anticlockwise, the slotted profde moves up and down. The arm 20 is fitted inside the slotted profile 31 such that the slot 20b receives the driving gear pin 26a and the attachment end 20a is connected to the driven pin 27a. When the lead screw rotates, it moves the arm up and down through the slotted profile, providing theengagement and disengagement mechanism for the needle. The arm pin 20c moves up and down through the baseplate profde 33. As can be seen in the FIGs. 4A and 4B, the attachment point 27c on the driven gear 27 and the driven pin 27a of the driven gear 27 are located on the respective gears at same radius, referred to as predefined radius.

[0089] The needle driving is achieved through cables coupled to the first motor in the handle. Cables run from first motor through its pulley 14, through routing pulleys 17, through the shaft, through the knuckle j oint 2, and connect to the driving gear 26. When the main trigger 9 on the handle is pressed, first motor rotates the driving gear 26. Since the driving gear pin 26a sits in the arm slot 20b and the arm end 20a is attached to the driven pin 27a, this configuration creates a parallelogram linkage. Rotation of the driving gear causes the arm to move in a circular arc motion, carrying the needle forward through tissue and back.

[0090] The engagement and disengagement is achieved through cables coupled to the second motor in the handle. Cables run from second motor through its pulley 15, through routing pulleys 17, through the shaft, through the knuckle joint 2, and connect to the lead screw 25. When the engagement / disengagement button 7 on the handle is pressed, second motor rotates the lead screw, which moves the slotted profile 31 and the arm up or down, raising or lowering the arm pin 20c through the baseplate profile 33 to engage or disengage from the needle holes. FIGs. 5A and 5B show working of the engagement-disengagement mechanism of the device, where FIG. 5A shows the arm 20 of the needle driving mechanism moved towards the needle 41b for the needle grasping pin 20c to engage with a hole of the needle 41c, and FIG. 5B shows the arm 20 of the needle driving mechanism moved away from the needle 41b for the needle grasping pin 20c to disengage from a hole of the needle 41c.

[0091] FIG. 6 shows the arm 20 in detail showing its three parts: slot 20b for receiving the slider block pivotally coupled to the driving gear pin 26a, and attachment end 20a for connection to driven gear 27. Also shown is the needle grasping pin 20c fixed to the other end of the arm 20.

[0092]

[0029] FIG. 7 shows the driving gear 26 showing a gear portion with the driving gear pin 26a, and cable hole 26c for attachment of driving cables (also referred to as first cables, herein) with crimps for clockwise and anticlockwise rotation. The driving gear 26 also includes a pulley portion for accommodating the first cables for rotating the driving gear 26,D. Complete Suturing Cycle — One Bite of Tissue

[0093] The complete six-step suturing cycle for one bite of tissue is as below:STEP 1 — ENGAGE (thread-side / blunt side hole): When the disposable needle cartridge 50 is loaded and the engagement button 7 on the handle is pressed, second motor activates and rotates the lead screw 25. The slotted profile 31 moves upward, raising the arm 20 and pushing the arm pin 20c upward through the baseplate profile 33. The arm pin enters the hole on the thread / blunt end side of the needle (the thread-side hole, near where the suture material 43 is attached). The device is now ready for suturing.STEP 2 — DRIVE FORWARD (bite tissue): When the main trigger 9 is pressed, first motor activates and rotates the driving gear 26 clockwise. The parallelogram linkage causes the arm to move in a circular arc from left to right, carrying the needle forward and driving it through the tissue. During this motion, the arm pin 20c remains engaged with the thread-side hole, and the suture material 43 follows the needle through the tissue.STEP 3 — DISENGAGE: second motor activates and rotates the lead screw clockwise, causing the slotted profile 31 to move downward, pulling the arm and arm pin 20c down. The arm pin withdraws from the thread-side hole and drops below the baseplate surface. The needle remains stationary in the tissue with the suture material 43 passed through.STEP 4 — RETURN ARM EMPTY : first motor activates and rotates the driving gear 26 anticlockwise. The arm returns from right to left in its circular path. Since the arm pin is in the DOWN position (disengaged), the arm moves freely without contacting or moving the needle, which remains in the tissue.STEP 5 — ENGAGE (pointed-end hole): second motor activates and rotates the lead screw anticlockwise, causing the arm to move upward again, raising the arm pin 20c through the baseplate profile 33. This time, the arm pin enters the hole on the pointed end side of the needle (the pointed-end hole).STEP 6 — PULL NEEDLE HOME: first motor activates and drives the arm back, carrying the needle by the pointed-end hole back to its original home position. One complete bite of tissue is now complete. The suture material 43 has been passed through the tissue.With the above six steps, the suture cycle is complete and the arm may now be disengaged from the pointed end side hole of the needle by activating the second motor to rotate the lead screw in clockwise direction to move the arm downward, and thereafter activating the first motor to drive the arm such that the distal end of the arm is parked adjacent the blunt end side hole of the needle for enabling the next suture cycle from the step 1 above.

[0094] The two holes in the suture needle are essential to this suturing cycle. The arm pin engages the blunt end side hole for the forward drive (so the suture material 43 follows the needle through) and then engages the pointed-end hole for the return (to bring the needle back).Without two separate holes, this engage-drive-disengage-retum-reengage-pull cycle would not be possible with a single arm pin.E. Disposable Suture Needle Cartridge

[0095] FIGs. 8A to 8C illustrate the disposable suture needle cartridge 50, which has a two-part design, as below:CARTRIDGE BODY 40: This is the packaging and handling portion that is discarded after loading. It comprises: (a) a thread wrapping area 40a where the suture thread is pre-wrapped during manufacturing and packaging; (b) a removal grip 40b that assists the surgeon or assistant in handling the cartridge 50; and (c) a breaking zone 40c — a designed fracture point that allows the cartridge body 40 to be cleanly snapped off from the main cartridge 41 after loading.MAIN CARTRIDGE 41 : This is the portion that remains in the suturing device after loading. It comprises: (a) a cartridge baseplate 41a that slides into the cartridge slot 32 of the device baseplate 23c; (b) the two-hole suture needle with pre-attached suture material 43; (c) a top cover 41c; and (d) snaps 4 Id, 41e that secure the main cartridge 41 to the device at snap engagement features 34a, 34b.Suture Needle Cartridge Loading Sequence:

[0096] The loading sequence includes: (1) The cartridge 50 comprising the cartridge body 40 and the main cartridge 41 is pushed into the device distal end, sliding into slot 32 of baseplate 23c. (2) The snaps 4 Id, 41e click into snap engagement features 34a, 34b, securing the main cartridge 41. (3) The hole in cartridge baseplate 41a aligns with the needle slot / profile 33 in the device baseplate 23c, positioning the needle holes directly above the path of the arm pin 20c. (4) The cartridge body 40 is snapped off at the breaking zone 40c and discarded. The suture material, previously wrapped on area 40a, now trails free from the needle 41b. (5) The engagement button 7 on the handle is pressed, activating second motor, which drives the lead screw 25 to raise the arm pin 20c through profile 33 into the needle’s thread-side hole. The needle is now positively engaged and the device is ready for suturing.

[0097] The suture needle cartridge loading and needle engagement process is designed such that the surgeon or surgical assistant does not need to manually handle the bare suture needle at any point, thereby preventing needle stick injuries. The needle is contained within the cartridge during loading, engaged by the arm pin mechanically, driven through tissue mechanically, and remains engaged with the device throughout the procedure. After theprocedure, the main cartridge 41 with the used needle is ejected as a unit by releasing the snaps and sliding it out, again without manual needle contact.

[0098] The suture needle cartridge 50 is the ONLY disposable component of the entire device. The entire device — including the driving mechanism, arm, pulleys, gears, lead screw, sensors, camera, electronics, motors, shaft, knuckle joint, and handle — is fully reusable and sterilized by autoclave between procedures.F. Handle Assembly

[0099] The handle assembly 4 (also referred to simply as handle 4 herein), as shown in FIG. 2, is the surgeon-operated portion of the device and comprises:FLUSH PORT 5: Located on the handle, it provides a port for flushing the internal channels of the device with cleaning solution after surgery, facilitating thorough cleaning prior to autoclave sterilization.ROTICULATION WHEEL 6: A rotatable control on the handle that controls the axial rotation (roll) of the shaft and distal end assembly. The roticulation wheel provides plus or minus 180 degrees of rotation (total 360 degree range) in a cable-driven, non-continuous manner. The roticulation wheel incorporates ball plunger-based positional locking, allowing the surgeon to lock the rotational position at any desired angle.ENGAGEMENT / DISENGAGEMENT BUTTON 7: When pressed, this button activates second motor 13 to rotate the lead screw 25 at the distal end assembly 1, causing the arm needle engaging pin 20c to move up (for engagement) or down (for disengagement) relative to the needle 41b. The engagement / disengagement button 7 is pressed once after loading anew cartridge 50 to engage the needle 41b, thereafter, the engagement / disengagement is automatically sequenced by the controller during the suturing cycle.ARTICULATION WHEEL 8: A control that manipulates the pitch (up and down) articulation of the distal end via the knuckle joint 2. The articulation wheel enables the distal end to be pitched up to 85 degrees relative to the shaft axis.MAIN TRIGGER 9: The primary suturing trigger. When pressed, the controller activates the two-motor suturing cycle (Steps 1-6 described above), with first motor and second motor sequenced automatically to complete one bite of tissue.REMOVABLE BATTERY 10: A detachable rechargeable battery pack that can be removed for charging at a separate station while the device is being sterilized, or replaced with a fresh battery between procedures.EPOXY-POTTED ELECTRONICS 11: The controller circuit board, sensor interfaces, motor drivers, wireless communication modules, and AI / ML processing components are all encapsulated in epoxy potting compound within the handle. This creates a hermetically sealed, waterproof enclosure that withstands repeated autoclave sterilization cycles [134 degrees Celsius, 18 minutes] without damage to any electronics.MOTORS AND PULLEYS: first motor 12 with pulley 14 provides the driving force for the needle driving cycle. The second motor 13 with pulley 15 provides the engagement / disengagement drive for the lead screw. Routing pulleys 17 guide the cables from the motor pulleys into the shaft for routing to the distal end assembly 1.ARTICULATION LOCKING 16: A ball plunger-based positional locking mechanism that locks the articulation (pitch) angle at any desired position between 0 and 85 degrees.G. Knuckle Joint, Articulation, and Roticulation

[0100] The knuckle joint 2, as shown in FIG. IE, connects the shaft 3 to the distal end assembly 1. The knuckle joint 2 is a pin-connected joint that enables angular movement in one plane, providing pitch (up and down) motion of the distal end relative to the shaft. The articulation range can be up to 85 degrees, controlled by the articulation wheel 8 on the handle. The articulation can be locked at any desired angle using the ball plunger locking mechanism 16.

[0101] When the device is configured as a device for laparoscopy surgery, the cables from the two motors can pass through the shaft and through the knuckle joint to reach the distal end assembly. The knuckle joint is designed to accommodate the passage of cables while maintaining smooth articulation and not impeding cable function even at extreme articulation angles.

[0102] The device provides two degrees of freedom for the distal end assembly: (a) Pitch — up and down angular movement of up to 85 degrees provided by the knuckle joint 2, with ball plunger positional locking at any desired angle via mechanism 16; and (b) Roll (roticulation) — axial rotation of the shaft and distal end assembly of plus or minus 180 degrees (total 360 degree range) with ball plunger positional locking at any rotational angle, controlled by the roticulation wheel 6, the roll being cable-driven and non-continuous. The combination of pitch and roll provides the surgeon with access to a wide range of orientations at the distal tip without repositioning the device through the trocar port.H. Integrated Optical Imaging Module

[0103] The baseplate 23c of the distal end assembly 1 also contains an optical imaging module, as shown in FIG. ID. The module comprises a miniature camera sensor 61 (such as a CMOS image sensor) having a resolution of at least 720p and a field of view of at least 60 degrees, configured to capture real-time images and video of the tissue being sutured and the needle during its driving cycle. One or more LED illumination elements may provide white light and / or near-infrared light to illuminate the surgical site. Optionally, a depth-sensing element such as a structured light projector or time-of-flight sensor enables three-dimensional tissue surface mapping.

[0104] Image data is transmitted to the controller 11 in the handle via signal cables routed through the shaft 3 and knuckle joint 2, or wirelessly to an external display, monitor, or headsup display. The camera captures at a minimum of 30 fps for smooth real-time visualization.I. Sensor Suite

[0105] The baseplate 23c also houses the tissue sensor suite 62 comprising: (a) a lightbased tissue sensor for measuring tissue thickness and density using optical wavelength analysis; (b) infrared proximity sensors for non-contact tissue distance measurement; and (c) pressure sensors for measuring compressive force during tissue contact. The combined sensor data provides real-time tissue characterization for the Al controller.J. Al-Powered Controller with Computer Vision

[0106] The device includes an Al-powered controller housed within the epoxy-potted electronics 11 of the handle. The Al-powered controller is embodied within MCUs of the electronic circuit shown in FIG. 10. The controller comprises: (a) a main processing unit; (b) a machine learning inference engine for tissue type classification and optimal force prediction; (c) a computer vision processing module for processing image data from the optical imaging module to perform tissue boundary detection, wound edge identification, real-time needle tracking, suturing path optimization, and stitch quality assessment; (d) a sensor fusion module aggregating data from all sensors and the camera; (e) a motor control module generating control signals for the first motor 12 and the second motor 13; (f) a wireless communication module with Bluetooth and Wi-Fi for loT integration, remote monitoring, telementoring, and robotic surgery compatibility; (g) non-volatile memory for storing trained ML models; and (h) a haptic feedback control module.

[0107] The controller dynamically adjusts torque of the first motor based on tissue characterization from the sensor fusion module, ensuring that delicate tissues receive gentle penetration force while dense tissues receive higher force. The ML models may be updated wirelessly. Sensor data, image data, and operational parameters may be transmitted to cloudbased analytics platforms for post-operative analysis.

[0108] The controller may include a sensor fusion module that aggregates data from the camera and the one or more sensors into a combined tissue characterization. The machine learning inference engine can process the combined tissue characterization using a pre-trained model stored in non-volatile memory to predict an optimal needle penetration force. The controller continuously monitors sensor data and camera data during the suturing cycle and adjusts the torque of the first motor in real-time during needle penetration through tissue, The computer vision processing module performs a pre-suturing assessment prior to activation of the suturing cycle comprising identifying tissue wound edges and calculating a recommended suture path, as well as a post-suturing stitch quality assessment after each completed suturing cycle. The first motor is equipped with a rotary encoder providing real-time angular position feedback to the controller for closed-loop control; and wherein the pre-trained model is updatable wirelessly via the wireless communication module.Camera Data Flow:

[0109] The miniature camera sensor 61 mounted on the baseplate 23c captures image frames and transmits raw image data to the MCU on PCB 1 via a serial data interface through dedicated signal cables routed through the shaft 3 and knuckle joint 2. The MCU processes the received image data through its computer vision processing module. The processed image data and analysis results may be displayed to the surgeon on an external monitor via wired or wireless connection, providing real-time visual feedback of the surgical site during the suturing procedure.Sensor Data Flow:

[0110] The tissue sensor suite 62 on the baseplate 23c transmits sensor data to the MCU on PCB1 via analog -to-digital converter channels or serial digital interfaces through signal cables routed through the shaft 3 and knuckle joint 2. The light-based tissue sensor emits optical wavelengths and measures reflected or transmitted light to determine tissue thickness and density. The infrared proximity sensors measure the distance between the sensor and the tissue surface without physical contact. The pressure sensors measure compressive force during tissue contact. The sensor data is sampled by the MCU at a rate sufficient for real-time feedback.Sensor Fusion and Adaptive Force Loop:[oni] The MCU aggregates data from all sensors 62 and the camera 61 in a sensor fusion module. The sensor fusion module combines tissue thickness from the light-based sensor, tissue distance from the infrared proximity sensors, tissue contact pressure from the pressure sensors, and tissue type classification from the computer vision module based on visual texture, colour, and structure analysis of the camera images. The fused sensor data is fed into the machine learning inference engine running on the MCU. The ML inference engine uses a pretrained model stored in non-volatile memory to predict the optimal needle penetration force for the specific tissue type and thickness being sutured. The predicted force is translated into a motor torque setpoint for the first motor 12, which the closed-loop control algorithm then executes using encoder feedback. This creates an adaptive force modulation system where the needle driving force is automatically adjusted in real-time based on the tissue being sutured, reducing force for thin delicate tissues and increasing force forthick dense tissues.Pre-Suturing Assessment:

[0112] Before the surgeon presses the main trigger 9 to initiate the suturing cycle, the camera 61 and sensor suite 62 provide a real-time pre-suturing assessment. The computer vision module identifies the tissue wound edges using edge detection and segmentation algorithms and calculates a recommended suture path. The tissue sensors characterize the tissue thickness and type at the intended suture entry point. This information may be displayed to the surgeon on the external monitor as a visual overlay on the camera image, showing the recommended needle entry point, exit point, and expected bite depth. The surgeon may approve the recommended path or adjust the device position before pressing the main trigger 9.During-Suturing Monitoring:During the suturing cycle (Steps 1 through 6 described in Section D), the camera 61 continuously captures images and the sensors 62 continuously sample tissue data. The MCU monitors needle position and trajectory via computer vision needle tracking, tissue deformation and resistance via pressure sensor readings, and needle penetration depth estimation via infrared proximity sensor feedback. If the sensor data indicates an anomaly such as unexpected tissue resistance, needle deviation from the planned path, or excessive force, the MCU can adjust the first motor speed or torque in real-time through the closed-loop control system using encoder feedback from the first motor 12. In an advanced embodiment, the MCU may pause or modify the suturing cycle and alert the surgeon via the LED indicator and buzzer if a critical anomaly is detected.Post-Suturing Assessment:

[0113] After each completed bite (Step 6), the camera 61 captures a post-bite image and the computer vision module performs a stitch quality assessment, evaluating uniformity of the stitch relative to previous stitches in the same suture line, bite depth consistency, distance from the wound edge, and suture material tension. The quality assessment results may be displayed to the surgeon on the external monitor. Over multiple suturing cycles, the ML inference engine may adapt its tissue-force model based on the observed tissue response, improving its force predictions for subsequent bites in the same procedure."Data Logging and Wireless Transmission:

[0114] All sensor readings, camera image data, motor position data, force profiles, and stitch quality assessments are logged by the MCU during the procedure. This operational data may be wirelessly transmitted in real-time via the wireless communication module (Bluetooth or Wi-Fi) to one or more of: an external display for the surgeon, a cloud-based analytics platform for post-operative analysis and quality assurance, a telementoring system for remote surgical guidance by an expert surgeon, or a hospital electronic medical record system for documentation. In robotic surgery configurations, the operational data and camera feed may be transmitted to the robotic master controller for integration with the robotic surgery platform." K. Reusable Device Architecture with Epoxy Potting

[0115] The entire device is reusable and designed for autoclave sterilization. All electronic components throughout the device — including the controller, sensor interfaces, motor drivers, camera processing electronics, and wireless modules — are encapsulated in epoxy potting compound with thermal resistance exceeding 200 degrees Celsius. The needle coupling interface at the cartridge slot 32 is designed with smooth, crevice-free surfaces for easy cleaning. The detachable battery 10 is removed before sterilization and replaced with a charged unit. The only component replaced between procedures is the disposable needle cartridge 50.L. Universal Platform — Open, MIS, and Robotic Surgery

[0116] FIGs. 11 to 13 in combination with FIG. 1A, illustrate a universal adaptability of the two-hole suture needle and the corresponding driving mechanism:(a) OPEN SURGERY: The surgical device 1100 is configured with a short handheld form factor, as shown in FIG. 11, without an elongated shaft. A disposable needle cartridge is loaded into the driving assembly.(b) MINIMALLY INVASIVE SURGERY: The device can be configured as a laparoscopic surgical device with an elongated rigid shaft, as shown in FIG. 1A, enabling insertion through cannulas (5 -12mm ports). The knuckle joint 2 provides 85 degree articulation with 360 degree roticulation at the distal end.(c) ROBOTIC SURGERY: The device can be configured as a robotic surgical device 1200, where the distal end assembly 1 can be configured as a tool tip / end effector mountable on a robotic arm 1202, as shown in FIG. 12. The robotic arm 1202 can provide motorized actuation, and the controller can wirelessly interface with a robotic master controller.(d) ENDOSCOPIC SURGERY: The device can be configured as a endoscopic surgical device 1300 with a flexible shaft 1302, as shown in FIG. 13. The flexible shaft 1302 can enable endoscopic surgery.

[0117] In all configurations, the core inventive concept is identical: the two- hole suture needle positively coupled to the driving mechanism via the arm pin passing through the holes, with the dual -motor engage-drive-disengage-retum cycle.M. Electronic Architecture and PCB Layout

[0118] FIG. 10 illustrates the electronic architecture of the device. The electronics are distributed across four printed circuit boards (PCBs) that together form the control, power, sensing, and user interface systems of the device:PCB1 (MAIN CONTROLLER BOARD):

[0119] Located inside the handle 4 and encapsulated in epoxy potting compound, PCB 1 houses the primary microcontroller unit (MCU) and a dual-channel motor driver. The MCU serves as the central processing and control unit of the device, executing the suturing cycle control logic, motor sequencing, and sensor data processing, image processing pipeline, AI / ML inference, and user interface management. The motor driver receives control signals from the MCU and provides regulated power and direction control to the first motor 12 and the second motor 13 through multiple drive channels. Both the fist and the second motors are equipped with rotary encoders that provide real-time angular position feedback to the MCU through encoder channels (Channel A, Channel B for each motor), enabling precise closed-loop control of motor rotation angle, speed, and direction. PCB1 also receives data from the camera and sensors located at the distal end assembly via signal cables routed through the shaft and knuckle joint. The MCU on PCB1 further comprises a wireless communication module (Bluetooth and Wi-Fi) for external connectivity. All components on PCB1 are encapsulated in epoxy potting compound to form a hermetically sealed, waterproof enclosure.PCB2 (MAIN TRIGGER BUTTON):

[0120] PCB2 is located on the exterior of the handle 4 and houses Button 1, which corresponds to the main trigger 9. Button 1 is operatively coupled to the MCU on PCB1 via a wired connection such that pressing Button 1 sends a digital input signal to the MCU, initiating the automated suturing cycle.PCB3 (ENGAGEMENT BUTTON AND LED INDICATOR):

[0121] PCB3 is located on the exterior of the handle 4 and houses Button 2, which corresponds to the engagement / disengagement button 7, and a multi-colour LED indicator. Button 2 is operatively coupled to the MCU on PCB 1 via a wired connection. The multi-colour LED indicator is driven by GPIO pins of the MCU and provides visual feedback to the surgeon regarding the device state.PCB4 (DETACHABLE BATTERY MODULE): PCB4

[0122] is housed within the detachable rechargeable battery pack 10 and comprises: (a) a secondary microcontroller unit (MCU2) for battery management; (b) the rechargeable battery pack (such as a lithium-ion or lithium-polymer cell); (c) a power button for powering the device on and off; (d) a buzzer for audible feedback; (e) a battery level LED indicator showing remaining charge state; and (f) charging circuitry with charge protection. PCB4 connects to PCB 1 through a magnetic connector interface comprising mating magnetic elements on PCB 1 and PCB4 that self-align and snap together. The magnetic connector carries power lines (V+, GND) for delivering battery power from PCB4 to PCB1, and signal lines for serial communication between MCU2 and the main MCU. This magnetic connector enables the battery module to be detached from the handle without tools for replacement during surgery, removal before autoclave sterilization, or charging at a separate station.

[0123] Thus the present disclosure provides a surgical device comprising a novel needle driving mechanism, a disposable suture needle cartridge and a suture needle thereof. In an aspect, the needle driving mechanism of the device works by engaging and disengaging with two holes provide in a needle body of the suture needle, and can be integrated across surgical platforms.

[0124] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions, or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

Claims

We Claim:

1. A surgical device for performing suturing procedures, the device comprising:a distal end assembly comprising:a needle driving mechanism for driving a suture needle along a circular path, the needle driving mechanism comprising an arm having a needle engaging end, wherein the arm is driven such that the needle engaging end of the arm undergoes a reciprocating circular movement between a first end and a second end that is spaced apart from the first end by 180 degrees; andan engaging-disengaging mechanism coupled to the arm to move the arm perpendicular to a plane of the circular path of the suture needle such that moving the arm towards the suture needle results in the needle engaging end of the arm engaging with the suture needle, and moving the arm away from the suture needle results in the needle engaging end of the arm disengaging from the suture needle;wherein the engaging-disengaging mechanism and the needle driving mechanism are configured to work in a predefined sequence to cause the suture needle to move by a complete 360 degrees revolution in two stages of 180 degrees each to complete a suturing cycle.

2. The surgical device as claimed in claim 1, comprising a disposable suture needle cartridge configured to accommodate the circular arc-shaped suture needle for movement along the circular path, wherein the suture needle cartridge is configured for a detachable coupling to a distal end of the distal end assembly, and wherein the surgical device is characterized by the disposable suture needle cartridge being the only disposable component of the surgical device.

3. The surgical device as claimed in claim 1, wherein the predefined sequence of working of the engaging -disengaging mechanism and the needle driving mechanism comprises: (i) engaging the needle engaging end of the arm with the suture needle close to the blunt side end of the suture needle, (ii) driving the suture needle along the circular path by 180 degrees; (iii) disengaging the needle engaging end of the arm from the suture needle; (iv) moving the arm back to starting position without the arm being in engagement with the suture needle; (v) engaging the needle engaging end of the arm with the suture needle close to the pointed end of the suture needle; (vi) driving the suture needle along the circular path by another 180 degrees to complete a full 360 degrees revolution of suture needle along the circular path; and (vii) disengaging the needle engaging end of the arm with the suture needle and moving the arm back to starting position without the arm being in engagement with the suture needle forrepeating the sequence for another full 360 degrees revolution of suture needle along the circular path.

4. The surgical device as claimed in claim 1, wherein the arm comprises a needle grasping pin located at the needle engaging end of the arm, and the suture needle comprises a first hole proximate to the pointed end of the suture needle and a second hole proximate to the blunt end of the suture needle and spaced apart from the first hole by 180 degrees such that when the arm is moved towards the suture needle the needle grasping pin engages with the first hole or the second hole to drive the suture needle, and when the arm is moved away from the suture needle the needle grasping pin disengages from the first hole or the second hole to allow the arm to undergo circular movement without driving the suture needle.

5. The surgical device as claimed in claim 1, wherein the needle driving mechanism comprises:a driving gear, wherein a proximal end of the arm is pivotally fixed to the driving gear at a predefined radius such that, when the driving gear undergoes rotation, the proximal end of the arm undergoes a circular movement;a driven gear in mesh with the driving gear for rotation when the driving gear undergoes rotation;a sliding block pivotally fixed to the driving gear at the predefined radius and in sliding engagement with a longitudinal slot in the arm;wherein the predefined radius is equal to a radius of the circular path of the suture needle such that when the driven gear is reciprocatingly rotated by 180 degrees, in the first direction and the second direction opposite the first direction, the distal end of the arm undergoes the reciprocating circular movement between the first end and the second end that is spaced apart from the first end by 180 degrees.

6. The surgical device as claimed in claim 5, wherein the driving gear comprises a gear portion and a pulley portion with a cable hole for attachment of two cables with crimps for enabling rotation of the driving gear in the first direction and the second direction.

7. The surgical device as claimed in claim 1, wherein the engaging disengaging mechanism comprises a lead screw in a threaded engagement with the arm such that rotation of the lead screw in a first direction causes the arm to move towards the suture needle, and rotation of the lead screw in a second direction opposite the first direction causes the arm to move away from the suture needle.

8. The surgical device as claimed in claim 5 or 6, wherein the device comprises a handle accommodating:a first motor coupled to the driving gear of the needle driving mechanism through first cable such that rotation of the first motor in a first direction and a second direction opposite the first direction results in the reciprocating circular movement of the arm;a second motor coupled to a pulley through second cables, which pulley is fixed to the lead screw of the of the engaging-disengaging mechanism such that rotation of the second motor in a first direction or a second direction opposite the first direction results in moving the arm towards or away from the suture needle.

9. The surgical device as claimed in claim 8, wherein the handle comprises a flush port for flushing internal channels of the surgical device with a cleaning solution after surgery.

10. The surgical device as claimed in claim 8, wherein the handle comprises an engagement-disengagement button located on the handle, the engagement-disengagement button being operatively coupled to the second motor such that actuation of the engagementdisengagement button rotates the second motor in the first direction to engage the arm with the suture needle after a detachable suture needle cartridge accommodating the suture needle is attached to the distal end assembly, or rotates the second motor in the second direction to disengage the arm from suture needle when the detachable suture needle cartridge is to be detached from the distal end assembly.

11. The surgical device as claimed in claim 8, wherein the device comprises a camera, one or more sensors and LED illumination elements located on the distal end assembly to sense and view tissues being sutured, wherein the camera, the one or more sensors and the LED illumination elements are operatively coupled to an electronic circuit located in the handle.

12. The surgical device as claimed in claim 11, wherein the electronic circuit comprises: electric drives for the first motor and the second motor, a controller incorporating a machine learning inference engine and a computer vision processing module; wherein the electronic circuit and its electronic components are encapsulated in a sealed enclosure by an epoxy potting compound to facilitate autoclave, gamma, ETO sterilization of the handle; wherein the epoxy potting compound protects the electronic components from damage during sterilization 13. The surgical device as claimed in claim 11, wherein the controller is configured to sequentially activate the first motor and the second motor for the suturing cycle.

14. The surgical device as claimed in claim 13, wherein the controller is configured to dynamically adjusts torque of the first motor to deliver a tissue-specific needle penetration force calculated by the machine learning inference engine based on tissue thickness and density measured by the sensors, such that the penetration force is automatically reduced for thin delicate tissues and automatically increased forthick dense tissues.

15. The surgical device as claimed in claim 14, wherein the controller comprises a sensor fusion module that aggregates data from the camera and the one or more sensors into a combined tissue characterization; wherein the machine learning inference engine processes the combined tissue characterization using a pre-trained model stored in non-volatile memory to predict an optimal needle penetration force; wherein the controller continuously monitors sensor data and camera data during the suturing cycle and adjusts the torque of the first motor in real-time during needle penetration through tissue; wherein the computer vision processing module performs a pre -suturing assessment prior to activation of the suturing cycle comprising identifying tissue wound edges and calculating a recommended suture path, and a post-suturing stitch quality assessment after each completed suturing cycle; wherein the first motor is equipped with a rotary encoder providing real-time angular position feedback to the controller for closed-loop control; and wherein the pre-trained model is updatable wirelessly via the wireless communication module.

16. The surgical device as claimed in claim 11 , wherein the handle comprises a main trigger operatively coupled to the controller such that pressing the main trigger activates the suture cycle.

17. The surgical device as claimed in claim 12, wherein the surgical device comprises a rechargeable battery detachably located in the handle to provide power to the first motor and the second motor and the electronic circuit.

18. The surgical device as claimed in claim 12, wherein the controller comprises a computer vision processing module for processing image data from the camera for at least one of tissue boundary detection, wound edge identification, real-time needle tracking, suturing path optimization, and stitch quality assessment.

19. The surgical device as claimed in claim 12, wherein the controller further comprises a depth-sensing module for three-dimensional tissue surface mapping based on a light projector and a time-of-flight sensor.

20. The surgical device as claimed in claim 11, wherein the electronic circuit comprises a wireless communication module for transmitting one or more of image data, sensor data, and operational parameters to at least one of an external display for surgical visualization, a cloudbased analytics platform, robotic surgery integration, loT applications, remote monitoring and a remote telementoring system.

21. The surgical device as claimed in claim 8, wherein the surgical device is adapted for minimally invasive laparoscopic surgery, and comprises a rigid shaft coupled to a distal end of the handle, and a knuckle joint coupled between a distal end of the shaft and the distal endassembly; wherein the knuckle joint is a pin-connected joint enabling up to 85 degrees of pitch articulation of the distal end assembly.

22. The surgical device as claimed in claim 21, further comprising a roticulation wheel on the handle providing plus or minus 180 degrees of axial rotation of the shaft and distal end assembly with ball plunger positional locking, and a ball plunger articulation locking mechanism for locking the pitch angle at any desired position23. The surgical device as claimed in claim 1, wherein the surgical device is adapted for robotic surgery; wherein the needle driving mechanism and the engagement-disengagement mechanism are actuated by a robotic arm through cables or direct mechanical coupling.

24. The surgical device as claimed in claim 8, wherein the surgical device is adapted for endoscopic and endoluminal surgery; and comprises a flexible shaft coupled between the distal end assembly and a distal end of the handle.

25. The surgical device as claimed in claim 1, wherein the surgical device is adapted for open surgery; wherein the distal end assembly is coupled to a handheld instrument,26. A suture needle for surgical suturing procedures, the suture needle comprising: an arcshaped needle body having a pointed end and a blunt end with suture material attached at or near the blunt end; a first hole provided on the needle body proximate to the pointed end, and a second hole provided on the needle body proximate to the blunt end; wherein the first and second holes are configured to receive an arm pin of a needle driving mechanism for positive mechanical coupling at different stages of a suturing cycle, and wherein an outer circumferential surface of the needle body between the first and second holes is free of surface notches, recesses, and indentations, presenting a smooth, uninterrupted profile for an atraumatic passage through tissue.

27. The suture needle as claimed in claim 26, wherein the needle body has a cross-sectional profile selected from round body and square body; the pointed end has a tip profile selected from taper point, taper cut, reverse cutting, and conventional cutting; and the suture material is selected from absorbable suture materials, non-absorbable suture materials, and barbed suture materials.

28. A disposable suture needle cartridge comprising:a main cartridge having a cartridge baseplate, a two-hole suture needle with preattached suture material, atop cover, and snaps provided on the cartridge base plate for securing the suture needle cartridge to a suturing device; anda cartridge body having a thread wrapping area and a removal grip coupled to the cartridge baseplate at a breaking zone;wherein the main cartridge is loaded into the suturing device by sliding the main cartridge into a cartridge slot of the suturing device, the snaps engaging at snap engagement features provided in the suturing device;wherein holes of the two-hole suture needle align with a profde in a baseplate of the suturing device to enable coupling of a needle grasping pin of a needle driving mechanism of the suturing device with the holes of the two-hole suture needle for driving the suture needle along a circular path; andwherein the cartridge body is snapped off at the breaking zone and discarded after insertion of the main cartridge has been loaded.

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