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

FIELD OF INVENTION
The present disclosure relates generally to flexible suturing device for a minimally invasive surgical application, especially flexible endoscopic surgery. In particular, the present disclosure relates to a hand-operated suturing device which enables controlled deployment of multiple continuous as well as interrupted sutures with or without a knot at a target site.
BACKGROUND
Unlike a conventional open surgery, where surgeons can easily visualize and manipulate both, tissue and instruments through a large incision, minimal invasive surgeries are inherently difficult. In minimal invasive surgeries, especially in endoscopic surgeries, a surgeon is required to operate at the target site remotely and externally, through instrument inserted at the target site through small punctures or natural orifices, such as the esophagus, nose, vagina, or the anus etc. The endoscopic surgical instruments are necessarily small, long and have multiple curvatures making them more challenging to manipulate with precision using external controls.
Endoscopic fundoplication surgeries and gastroplication surgeries are kind of minimally invasive surgeries widely used for treatment of Gastro-esophageal reflux disease (GERD), hiatal hernia, fat reduction, and/or weight loss purposes. More specifically, Endoscopic Fundoplication is a surgery for treatment of GERD and hiatal hernias, whereas Endoscopic Gastroplication is a surgery for weigthloss and obesity. Fundoplication surgery includes folding of upper part of the fundus of stomach over the lower esophageal segment followed by joining or fastening them together. The joining process is repeated at different axial and rotary positions until the desired fundoplication is achieved. This strengthens the lower esophagus sphincter or esophagus valve that achieves desired benefit, such as to prevent Gastroesophageal reflux disease (GERD). In a gastroplication surgery, multiple interrupted sutures, at least 5 or 6, are taken in the stomach, to reduce the capacity of the stomach. This will reduce the appetite of the person and limit the food intake leading to weight/fat loss.
The success of a minimal invasive surgery instrument is dependent upon the adjoining means used for joining nearby target tissues. For example, a fundoplication surgery requires the joining of the upper part of the fundus stomach over the lower esophageal segment, which is the most challenging step because of the flexibility of the stomach wall. Extension of the stomach wall upon food intake exerts high pressure on the stitches placed at a normal state of stomach wall, which is sufficient to tear or open the stitches and thereby jeopardizing the patients' health. Therefore, an ideal fastener for fundoplication surgery must include flexibility as well as high mechanical/impact strength.
Various adjoining means used conventionally in minimally invasive surgeries for joining the tissues at the target site include sutures, staples or nails, clips, tacks, clamps etc. Staplers are as accurate as sutures but do not provide the advantage of adjustable tension obtained by the knotting of a length of suture material and are not suitable for all target sites mostly due to anatomic constraints. Due to these reasons, currently sutures are proven being more suitable for fundoplication application and all other surgical applications, where tissue approximation is required.
Placement of sutures requires coordinated manipulation of suturing thread(s) and needle(s) with target tissues, but anatomic constraint and limited visibility of the target site make it difficult to maneuver the suturing device, which may increase the chances of accidental needle pricks or collateral damage in nearby areas. The accidental needle pricks may lead to infection or post-surgery trauma at the target site. Besides, most of the current suturing device requires more than one person to operate conventional suturing device which increases the complexity of handling the suturing process. This problem is exaggerated when the surgical procedure requires the deployment of multiple single sutures at the target site. Most of currently available suturing devices require specific arrangement of the target tissues at the target site, such as in X or Y configuration to place proper stitches, which is not convenient in all cases. Attempts also have been made to incorporate a motor or like mechanism to rotate needle(s) to enable automatic suturing for reduced or substantially minimized scarring and reducing suturing time. But motor incorporation disables the surgeon from efficiently controlling the location of stitches placed in real-time.
Clinical Need: Both GERD and obesity are extremely common lifestyle disorders and the worldwide prevalence of each will be in the range of 15-20%. Currently the treatment of both is either medical treatment or laparoscopic surgery. Thus there is a strong need for developing scar-less and effective daycare procedures for both these conditions. Currently there is no effective suturing device which can do both these procedures.
Sufficient vision required to perform surgery is a challenge, which can primarily be solved by currently available flexible endoscopes but positioning them and controlling its motion along with the main device becomes a greater challenge due to parallel vision.
Hence, there is a much long-felt need for a suturing device that enables a surgeon to efficiently and accurately deploy continuous or interrupted sutures at a target site in a minimal invasive surgery, especially fundoplication surgery and gastroplication surgery.
SUMMARY
In accordance with an embodiment of the present disclosure, a flexible suturing device for a minimal invasive surgery is provided. The flexible suturing device comprises a needle cartridge, a first link, a hollow cylinder, an annular link and rotor.
The needle cartridge defines a first circular needle track configured to at least partially cover a needle when disposed therein. The first link houses a hollow cylinder having a plurality of spiral traction paths formed thereon. The annular link is configured to be rotate axially on the spiral traction paths of the hollow cylinder and has a plurality of rotation knobs formed on outer side thereof configured to traverse on the plurality of spiral traction paths.
The rotor has a circular core and a plurality of supporting legs extending from the circular core. The circular core is adapted to be seated on proximal end of hollow cylinder and plurality of supporting legs are configured to engage with the annular link to rotate the rotor in correspondence with the traversal of the annular link within hollow cylinder.
The flexible suturing device further comprises a first set of control wires configured to control traversal of the annular link on the spiral traction path of the hollow cylinder and a second set of control wires configured to control the maneuvering and steering of the flexible suturing device.
The annular link has a plurality of slits formed in direction perpendicular to its rotational axis. Here, the plurality of the supporting legs of the rotor is configured to pass through the plurality of slits. Annular link has at least two numbers of rotation knobs and at least two numbers of slits. Here, plurality of rotation knobs of the annular link is in one-to-one correspondence with the plurality of spiral traction paths of the hollow cylinder. Similarly, plurality of slits in the annular link is in one-to-one correspondence with the plurality of supporting legs of the rotor.
The first link is provided with a spring configured to control traversal of the annular link on the spiral traction path.
The flexible suturing device further comprises a handle which is connected with the flexible suturing device via an elongate shaft. Handle comprises a plurality of controlling means to control the first set of control wires and the second set of control wires to control maneuvering and steering of the suturing device at the target site. Here, a first set of control wires extending from the handle to the annular link and the second set of control wires running from the handle till distal end of hollow cylinder.
The flexible suturing device further comprises a third link provided at the proximal end of the elongate shaft, and a second link provided at the distal end of the first link. Here, the first link is connected with the elongated shaft via the second link and the third link and the second set of control wires is adapted to control degree of orientation of the second link.
The flexible suturing device further comprises a third set of control wires adapted to control degree of orientation of the first link. Here, the first link is configured to rotate upto 270 DEG within target site. In a preferred embodiment of the invention, the needle is an arced needle having a sharp end, a blunt end, and a length of a suture.
OBJECT OF THE INVENTION
An object of the invention is to provide a suturing device that enables placement of continuous as well as interrupted stitches with a knot at a target site in a minimally invasive surgery without causing collateral damage at the target site.
Another object of the invention is to provide a suturing device, articulation, roticulation and locking of which can be achieved from outside the body using a single hand control.
Yet another object of the invention is to provide a suturing device that enables placement of multiple single stitches with a knot at the target site in a minimally invasive surgery.
Yet another object of the invention is to provide a suturing device having improved maneuverability within the target site, especially the target site having smaller and irregular/curvy anatomy.
Yet another object of the invention is to provide a suturing device which has upto 180 degrees of articulation and upto 360 degree rotation capability forming a spherical working zone within the target site, improving movability and control of the suturing.
Still another object of the invention is to provide a suturing device that allows a user to fully control the rotation of needle as well as placement of a stitch and knot at the target site in a minimally invasive surgery.
The device is able to perform various tasks such as gripping, holding, lifting, cutting, moving the tissue, automatic suturing and knotting once the surgical procedures are done.
BRIEF DESCRIPTION OF DRAWING
The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the present 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. Wherever possible, like elements have been indicated by identical numbers.
Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
FIG. 1 shows a schematic representation of the flexible suturing device when in use in accordance with an embodiment of the present invention.
FIG. 2a shows an external view of the flexible suturing device in accordance with an embodiment of the present invention.
FIG. 2b shows an internal view of the flexible suturing device in accordance with an embodiment of the present invention.
FIG. 3a shows an extended view of the flexible suturing device in accordance with an embodiment of the present invention.
FIG. 3b shows a top isometric view of a first part of the flexible suturing device in accordance with an embodiment of the present invention.
FIG. 3c shows a side perspective view of the first part of the flexible suturing device in accordance with an embodiment of the present invention.
FIG.4 shows a top isometric view of a proximal end of the flexible suturing device in accordance with an embodiment of the present invention.
FIG. 5a)-5d) shows traversal of the first part of the flexible suturing device in accordance with an embodiment of the invention.
FIG. 6a)-6g) shows different configurations of the flexible suturing device in accordance with an embodiment of the invention.
DEFINITIONS
Referring to attached drawings, embodiments of the invention will be described below. “inner”, “outer”, “upper” and “lower”, “inside” denote each position of a suturing device when in use. The drawings shall be viewed with regard to the reference numbers.
As used herein, the term “at”, for example when referring to something being located “at” a specific location, is intended to include any one or more of: proximate, on, near, adjacent to or within the specific location.
As used herein, the terms “distal” and “proximal” are defined with respect to the patient, on whom suturing device is used during surgical application. In other words, the term “distal” refers to the part or portion further away from the patient, while the term “proximal” refers to the part or portion closer to the patient.
As used herein, the terms “patient” or “subject” refers to an individual on which the surgery is performed can be a person or an animal.
As used herein, the terms “user”, “operator” or “surgeon” is intended to refer to any person who is performing surgical procedure on a patient. Such a person can be a surgeon, physician, physician assistant, advanced practice registered nurse, veterinarian, or other health care provider.
As used herein the terms "surgery", "surgical procedure" or "medical procedure" refers to an activity directed at or performed on an individual (e.g.. patient) intended to achieve a result in the care of the individual with an object of improving health, treating disease or injury, making a diagnosis; specifically the term "surgery", "surgical procedure" refers an act of performing surgery and may be called a surgical procedure, operation, or simply surgery performed by a surgeon or other person in the performance of a medical procedure using operative and instrumental techniques on a patient to investigate and/or treat a pathological condition, disease, injury, to help improve bodily function, structure and/or appearance, or to repair unwanted broken joints, tissues, or ruptured areas on a patient to in the medical specialty context.
The term "minimal-invasive surgery," or "MIS," refers to surgical procedures for treatment, diagnosis, and/or examination of one or more regions of a patient's body using surgical and diagnostic instruments specially developed to reduce the amount of physical trauma associated with the procedure. Generally, MIS involves instruments that may be passed through natural or surgically created openings of small diameter into a body to their location of use so that examinations and minor surgical interventions are possible with substantially less stress being imposed on the patient, for example, with or without general anesthesia. MIS may be accomplished using visualization methods, such as fiber-optic or microscopic means. Examples of MIS include, for example, arthroscopic surgery, laparoscopic surgery, endoscopic surgery, thoracic surgery, neurosurgery, bladder surgery, gastrointestinal tract surgery, etc.
As used herein, the phrase “operatively connected” is intended to mean “coupled or connected, either directly or indirectly, such that the connected structures are operable to perform a desired function”.
Finally, as used herein, the term “fully disposed” refers to a first member being substantially fully received within a second member such that, under normal use, it is not intended to be inserted. into the other member any further.
DETAILED DESCRIPTION
The detailed description set forth below in connection with the appended drawings is intended as a description of certain embodiments of a flexible suturing device and is not intended to represent the only forms that may be developed or utilized. The description sets forth the various structure and/or functions in connection with the illustrated embodiments; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
In a broader aspect, the present invention comprises a flexible suturing device 100 (Referred to hereinafter as “device 100” for purpose of brevity) which is intended primarily for minimal invasive surgery (Referred to hereinafter as “MIS” for purpose of brevity), especially in endoscopic MIS. Compared to prior suturing device, the device 100 is capable of being reused after sterilization and has ergonomic design which enables the operator to control the device using only single hand keeping other hand free for other surgery related work.
Figure 1 shows a schematic representation of the device 100 when in use in accordance with a preferred embodiment of the present invention. The device 100 is operatively connected with handle 110 via an elongated shaft 111. The elongated shaft 111 is a hollow flexible tubular structure which may has any desirable length depend upon the distance between an entry site to a target site in a patient. Therefore, length of the elongated shaft 111 is not limited herein. The elongated shaft 20 is substantially cylindrical and having equal diameters at both the proximal and distal ends thereof. Device 100 optionally provided with an endoscopic means 40 passing therethrough which can be taken out as a tentacle when needed during surgical application.
FIG. 2a shows an external view of device 100 according to an embodiment of the present invention. In a preferred embodiment of the present invention, device 100 comprises a needle cartridge 10d, rotor cover 10e, a plurality of links connected with each other, namely a first link 10a, a second link 10b and a third link 10c. While a preferred embodiment of the invention has been described herein with reference to only three links, it is to be appreciated that various changes, modifications, and rearrangements can be made using more number of links, for example, upto ten links, without departing from the scope and essence of the invention as defined in the appended claims. The number of links to attach with the first link 10a is selected based on the degree of articulation required during surgery. Each of first link 10a, second link 10b and third link 10c are tubular structure of same diameter having lumen(s) allowing other components of the device 100 to pass therethrough, and each link has been operatively connected to each other via mechanical connector. Such mechanical connector can be bolts, nuts, or like fastener known in the art. In a preferred embodiment of the invention, a first link 10a has length of at least 30 mm, and more preferably of 40 mm. Other links, i.e. second link 10b and third link 10c here, has a length which may be more or less than the length of the first link 10a.
FIG. 2b shows internal view of the device 100 according to an embodiment of the present invention. Device 100 comprises a rotor 104 partially housed inside rotor cover 10e, a hollow cylinder 102 and an annular link 103 fully disposed inside the first link 10a. Needle 101 is adapted to be partially disposed inside the needle cartridge 10d.
FIG. 3a shows an extended internal view of device 100 according to an embodiment of the present invention. Device 100 comprises needle cartridge 10d adapted to house needle 101, rotor cover 10e adapted to partially cover rotor 104, while first link housing a hollow cylinder 102, annular link 103, and spring 105. Hollow cylinder 102 has a plurality of spiral traction paths 102a formed as cut outs thereon. Annular link 103 is adapted to be fully disposed within hollow cylinder 102.
FIG. 3b shows a top isometric view of the annular link according to a preferred embodiment of the invention. The annular link 103 is provided with a plurality of rotation knobs 103a formed on the outer side thereof. Here, the plurality of rotation knobs 103a are configured to slide on the plurality of spiral traction paths of 102a hollow cylinder 102 when disposed inside hollow cylinder 102.
Further, annular link 103 has a plurality of slits 103b formed in the direction perpendicular to the rotational axis thereof. In an embodiment of the invention, a plurality of rotation knobs 103a of the annular link 103 are in one-to-one correspondence with the plurality of spiral traction paths 102a of the hollow cylinder 102. In a preferred embodiment of the invention, the number of rotation knobs is same as number of spiral traction path 102a formed on the hollow cylinder 102. Rotation knobs may have structure similar to metal ball projected from the outer side of the annular link and may has shape round, crescent, or like that enables the link to slide over the spiral traction path 102a.
Referring back to FIG. 3a, rotor 104 comprises a circular core 104a having plurality of supporting legs 104b extending from the inner surface of the circular core 104a and a needle engaging notch 104c provided on upper surface thereof. Rotor 104 is arranged in a manner that circular core 104a is seated on the proximal end of hollow cylinder 102 while plurality of supporting legs 104b is extending within the hollow cylinder 102 until distal end thereof, while the needle engaging notch 104c is positioned outside the hollow cylinder 102 to engage needle 101 housed in needle cartridge 10d.
In an embodiment of the invention, the plurality of slits 103b in the annular link 103 are in one-to-one correspondence with the plurality of supporting legs 104 of the rotor 104.That is, the plurality of supporting legs 104b of rotor 104 extend until the distal end of hollow cylinder 102 while passing through the plurality of slits 103b formed in the annular link 103 (See FIG. 3c). In a preferred embodiment of the invention, number of slits 103b in the annular link is equal to the number of plurality of supporting legs 104b of rotor 104. In a preferred embodiment of the invention, annular link 103 has at least two numbers of rotation knobs 103a and at least two numbers of slits 103b. In a preferred embodiment of the invention, annular link 103 has two or three number of rotation knobs 103a and two or three number of slits 103b, however the same is not limited herein.
A rotor cover 10e is adapted to cover the circular core 104a along with needle engaging notch 104c. Rotor cover 10e defines a second circular track 109 for needle engaging notch 104c therein. Rotor cover 10e is provided on the proximal end of the hollow cylinder 102. Circular core 104a is adapted to be seated on proximal end of hollow cylinder 102 and plurality of supporting legs 104b are configured to engage with the annular link 103 to rotate the rotor in correspondence with the traversal of the annular link 103 within hollow cylinder 102.
FIG.4 shows a top isometric/schematic view of the proximal end of suturing device 100 in accordance with an embodiment of the invention. Needle cartridge 10d defines a first circular needle track 101b therein and is configured to at least partially cover the needle 101 when needle 101 is disposed in the first circular needle track 101b. In a preferred embodiment of the invention, the needle 101 is an arched needle having a sharp end x, a blunt end y, and a length of a suture z. In a preferred embodiment of the invention, the needle 101 is adapted to take suture in particular manner such that it takes around 5 to 7 bites of a tissue and make a bigger stitch, binding entire space between 1st bite and last bite of a tissue after a knot. In a preferred embodiment of the invention, needle 101 is adapted to take a plurality of interrupted stitches secured with knots. In a preferred embodiment of the invention, the needle cartridge has C or crescent-shape. Needle 101 is in operative engagement with needle engaging notch 104c of rotor 104, a plurality of supporting legs 104 b of which is extending within hollow cylinder 102. Hollow cylinder 102 is same as first link 10a.
Further, a spring 105 is provided in the hollow cylinder 102 at the lower part thereof. The spring 105 is configured to control the traversal of the annular link 103 over spiral tracking path in association with a first set of control wires 106. This enables controlled deployment of stitches at target site.
FIG.5a)-5d) shows traversal of annular link 103 of the device 100 in accordance with a preferred embodiment of the invention. During assembly, the annular link 103 is first inserted within the hollow cylinder 102 such as it is fully disposed therein. More specifically, the annular link 103 is mounted within the hollow cylinder 102 in a manner that enables each rotation knob 103a of the annular link 103 to be in one-to-one contact with each of plurality of spiral traction paths 102a of the hollow cylinder 102. This arrangement enables the annular link 103 to linearly rotate upside and downside within the hollow cylinder 102 via rotation knob 103a sliding back and forth on the spiral traction paths 102a. In an alternative embodiment, the hollow cylinder 102 is provided with an annular link 103 as an integral internal component.
Further, as plurality of supporting legs 104b of rotor 104 pass through the slits 103b formed in the annular link 103 arranged inside the hollow cylinder 102, axial sliding of annular link 103 over spiral traction path 102a causes rotational motion to the rotor 104. This arrangement enables conversion of spiral motion of annular link 103 in hollow cylinder 102 to be converted into the circular rotation of the rotor 104, causing needle engaging notch 104c to rotate within second circular track 109. FIG.5a)-5d) clearly shows linear motion of annular link causing circular motion of needle engaging notch 104c of rotor 104.
Needle cartridge 10d is mounted on the rotor 104 such that the needle engaging notch 104c of the rotor 104 engages the needle 101 located inside the first circular needle track 101b from a sharp end thereof. The needle engaging notch 104c enables the advancement of needle 101 upon rotation of rotor 104.
Device 100 further comprises a first set of control wires 106 (not shown), a second set of control wires 107 (not shown) and a third set of control wires 108 (not shown) to control manoeuvring and steering of the device 100 as well as suturing action by the device 100. The first set of control wires 106, the second set of control wires 107 and the third set of control wires 108 are externally operated by the user in a known manner such as via plurality of controlling means such as actuators provided on the handle 111. Such controlling means 113 (not shown) can include but not limited to press actuator, knob actuator, etc. The handle 110 is rigidly attached to an elongated shaft 111 to manipulatively control the first set of control wires 106, the second set of control wires 107 and the third set of control wires 108 passed therethrough. In a preferred embodiment of the invention, first set of control wires 106 extending from the handle 110 to the annular link 103 and second set of control wires 107 running from handle 110 till distal end of hollow cylinder 102. Third set of control wire 108 extend from handle 110 till proximal end of second link.
At time of suturing, user/surgeon operates the first set of control wires 106 which makes the annular link 103 to be pulled downside. Consequently, rotation knobs 103a slide over spiral track paths 102a causing the annular link 103 to move axially downward while rotating spirally. This makes the supporting legs 104b passing through the slits 103b to be rotated along with axial downward rotation of the annular link 103 causing rotation of rotor, i.e., needle engaging notch 104c, which advances the needle 101 inside the first circular needle track 101b. In a preferred embodiment of the invention, one time motion of the annular link 103 from the upper part of the hollow cylinder 102 toward lower part of the hollow cylinder 102 provide the needle 101 upto 270 DEG of rotation. At a start, the needle engaging notch 104c is engaged with the blunt end of the needle. Upon rotation, the sharp end of the needle is pushed out of the needle cartridge 10d at first end and then re-enter from the other end of the needle cartridge 10d, penetrating the target tissue located between the first end and the second end of the needle cartridge 10d following needle’s natural arced path. Releasing the tension applied on the spring 105 cause annular link 103 to advance upside while rotating over the spiral tracking path 102a, causing needle engaging notch 104c to disengage from the blunt end of the needle and move reverse to the distal end of the second circular needle track 109 and engage with the sharp end of the needle 101 re-entered therein after penetration into the target tissue. Upon reoperation of first set of control wires rotor repeats the same motion and pulls needle in its natural arc inside the needle track at least 180 degrees completing one rotation and thus one stitch. The user can also control the sliding of the annular link over spiral tracking paths by controlling tension applied on the spring 105 by the user via controlling the first set of control wires. Thus, first set of control wires 106 are adapted to effectively control the suturing procedure.
The first link 10a, second link 10b and third link 10c are mechanically linked with each other to control the manoeuvring and steering of the device 100.
The second set of control wires 107 and third set of control wires 108 are configured to control the maneuvering and steering of the device 100 at the target site by controlling orientation of first link 10a and second link 10b. Second link 10b act as a connector between the first link 10a and third link 10c, while third link 10c act as connector for second link 10b with proximal end of elongated shaft 20. In simpler words, second link 10b connects the distal end of hollow cylinder 102 of device 100 with elongated shaft 111 through third link 10c provided at the proximal end of the elongated shaft 111. The second set of control wires 107 and the third set of control wires 108 respectively control the orientation of first link 10a and second link 10b to control the orientation of the device 100 upto 180 DEG to effectively perform suturing operation in a confined target site.
Device 100 is capable of being locked at different angles forming different suturing position by controlling orientation of the first link 10a relative to third link 10c. FIG. 6a)-6g) shows different configurations of the first link 10a, second link 10b and third link 10c relative to each other in accordance with a preferred embodiment of this invention. More specifically, FIG.6a)-6g) shows orientation of the first link 10a at 0, 30, 60, 90, 120, 150 and 180 DEG respectively to third link. In an embodiment of the invention, first link 10a can be oriented at an angle upto 230 with respect to third link. This flexible orientation of first link 10a enables device 100 to perform various tasks such as gripping, holding, lifting, cutting, moving the tissue, automatic suturing and knotting etc in very a tight spaces. Once inside the patient’s body through single point entry the device 100 is capable of creating a 360-degree spherical working zone at the target site within which manoeuvring and steering of the device 100 is controlled externally (via handle 110) via the second set of control wires 107 and third set of control wires 108. In a preferred embodiment of the invention, first set of control wires 106 controls upward and downward motion of the annular link 103, thereby needle engaging notch 104c and thereby suturing motion of needle 101 within needle cartridge 10d. Second set of control wires 107 and third set of control wires 108 are configured to control movement of first link 10a, second link 10b and third link 10c causing upto 180 DEG rotation of suturing head 10. Further, device 100 means comprises locking means to lock the first link 10a, second link 10b and/or third link 10c in a particular configuration as per need of the MIS.
The second link 10b and third link 10c has a first cylindrical passage 112a, and second cylindrical passage 112b, respectively formed therein through which additional surgical aid instruments are passed to support the suturing process. For example, Endoscopic camera can be introduced through it and can be taken out as a tentacle from the device 100 to increase the visibility of the target site in real time. The both cylindrical passages 112a and 112b have a same diameter, ranging between of 5-10 mm. The kind and type of surgical aid instruments is not limited herein. In a preferred embodiment of the invention, annular link 103 provided within the hollow cylinder 102 of the first link 10a has inner diameter ranging between 5-10 mm, and is also provides passage for additional surgical aid instruments in align with cylindrical passages 112a and 112b. In a preferred embodiment of the invention, the device 100 has a diameter of 10-20 mm, more preferably 12-15 mm.
In a preferred embodiment of the invention, a biocompatible sleeve 113 (not shown) has been provided which entirely encloses the flexible suturing device 100. The biocompatible sleeve 113 forms a biocompatible and air-tight enclosure for the flexible suturing device 100, which can be sterilize after each use to increase the safety of the device 100.
In brief, the present disclosure provides a flexible suturing device that is configured to deploy sutures at a target site by rotating the arched needle at 180 degree twice, thus completing 360 degree rotation, while avoiding the need of arranging the target tissue in any specific configuration such as X, Y or like configuration. Alternatively, the flexible suturing device 100h is configured to deploy sutures at a target site by first rotating the needle at degree more than 180 degrees followed by rotating the needle at degree less than 180 or vice versa, in a manner that enables the needle to complete 360 degree of rotation. The present disclosure relates to using a separate set of control wires to control needle rotation and to control maneuvering of the suturing device, enabling the suturing device to rotate 360 DEG at the target site while keeping the needle at desired position. Suturing device of the present disclosure is configured to rotate the needle by the rotation of a rotor 104, which is rotated in correspondence with the movement of the annular link 103 over the spiral traction path 102a of the hollow cylinder 102. Controlled (non-motor) needle advancement at the target site provides better control of real-time needle advancement during suturing compared to as achieved by using prior needle advancement means. Further, the suturing device 100 of the present disclosure enables placement of interrupted (single) or continuous stitches in a smallest target site following by tying knot at the end of each stitch(es). That makes this suturing device more applicable to even complex minimal invasive surgeries. Such minimal invasive surgeries may include, but not limited to, Natural orifice transluminal endoscopic surgery (NOTES), microsurgery, endoscopic surgery, laparoscopic surgery, fundoplication surgery, arthroscopic surgery, cancer surgeries, etc. The flexible suturing device can be operated through any natural orifices which include but are not limited to, transoral, transrectal, transvaginal, inside the lumen or outside the lumen of the bowel route of insertion etc.
Although embodiments have been described with reference to a number of illustrative embodiments thereof, it should be understood that numerous other modifications and embodiments can be devised by those skilled in the art that will fall within the spirit and scope of the principles of this disclosure. More particularly, various variations and modifications are possible in the component parts and/or arrangements of the subject combination arrangement within the scope of the disclosure, the drawings and the appended claims. In addition to variations and modifications in the component parts and/or arrangements, alternative uses will also be apparent to those skilled in the art.
,CLAIMS:We claim:
1. A flexible suturing device (100) for a minimal invasive surgery (MIS) comprising;
a needle cartridge (10d) defining a first circular needle track (101b) therein, wherein the needle cartridge (10d) is configured to at least partially cover a needle (101) when disposed therein;
a first link (10a) housing a hollow cylinder (102) having a plurality of spiral traction paths (102a) formed thereon;
an annular link (103) configured to be rotate axially on the spiral traction paths (102a) of the hollow cylinder (102), wherein the annular link has a plurality of rotation knobs formed on outer side thereof configured to traverse on the plurality of spiral traction paths (102a);
a rotor (104) comprising a circular core (104a) and a plurality of supporting legs (104b) extending therefrom, wherein the circular core (104a) is adapted to be seated on proximal end of hollow cylinder (102) and plurality of supporting legs (104b) are configured to engage with the annular link (103) to rotate the rotor in correspondence with the traversal of the annular link (103) within hollow cylinder (102),
a first set of control wires (106) configured to control traversal of the annular link (103) on the spiral traction path (102a) of the hollow cylinder (102);
a second set of control wires (107) configured to control the maneuvering and steering of the flexible suturing device (100).
2. The device according to claim 1, wherein the annular link (103) further comprises a plurality of slits (103b) formed in direction perpendicular to the rotational axis thereof, wherein the plurality of the supporting legs (104b) of the rotor (104) are configured to pass through the plurality of slits (103b).
3 The device according to claim 2, wherein the annular link (103) has at least two number of rotation knobs (103a) and at least two number of slits (103b).
4. The device according to claim 2, wherein the plurality of rotation knobs (103a) of the annular link (103) is in one-to-one correspondence with the plurality of spiral traction paths (102a) of the hollow cylinder (102).
5. The device according to claim 2, wherein the plurality of slits (103b) in the annular link (103) is in one-to-one correspondence with the plurality of supporting legs (104b) of the rotor.
6. The device according to claim 1, wherein the first link (10a) further comprising a spring (105) configured to control traversal of the annular link (103) on the spiral traction path (102a).
7. The device according to claim 1 further comprises a handle (110) which is connected with the device (100) via an elongate shaft (111), wherein the handle (110) comprises a plurality of controlling means (113) to control the first set of control wires (106) and the second set of control wires (107) to control maneuvering and steering of the device (100) at the target site, wherein the first set of control wires (106) extending from the handle (110) to the annular link (103) and the second set of control wires running from the handle (110) till distal end of hollow cylinder (102).
8. The device according to claim 1 further comprises a third link (10c) provided at the proximal end of the elongate shaft (111), and a second link (10b) provided at the distal end of the first link (10a), wherein the first link is connected with the elongated shaft via the second link (10b) and the third link (10c), wherein the second set of control wires is adapted to control degree of orientation of the second link (10b).
9. The device according to claim 1 further comprises a third set of control wires (108) adapted to control degree of orientation of the first link (10a), wherein the first link is configured to rotate upto 270 DEG within target site.
10. The device according to claim 1, wherein the needle (101) is an arched needle having a sharp end, a blunt end, and a length of a suture.