WO2021234508A1 - Polypectomy device for excision of polyps and method employed thereof - Google Patents

Polypectomy device for excision of polyps and method employed thereof Download PDF

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Publication number
WO2021234508A1
WO2021234508A1 PCT/IB2021/054036 IB2021054036W WO2021234508A1 WO 2021234508 A1 WO2021234508 A1 WO 2021234508A1 IB 2021054036 W IB2021054036 W IB 2021054036W WO 2021234508 A1 WO2021234508 A1 WO 2021234508A1
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Prior art keywords
polyp
forceps
forceps jaw
jaw
peduncle
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PCT/IB2021/054036
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French (fr)
Inventor
Rami Reddy YALAKA
Original Assignee
KASI REDDY, Sindhura
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Publication of WO2021234508A1 publication Critical patent/WO2021234508A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/32056Surgical snare instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00353Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/2812Surgical forceps with a single pivotal connection
    • A61B17/282Jaws
    • A61B2017/2825Inserts of different material in jaws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482Digestive system
    • A61B2018/00494Stomach, intestines or bowel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482Digestive system
    • A61B2018/005Rectum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00559Female reproductive organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601Cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063Sealing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • A61B2018/141Snare
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • A61B2018/1452Probes having pivoting end effectors, e.g. forceps including means for cutting

Definitions

  • the disclosed subject matter relates generally to surgical/endoscopic instruments. More particularly, the present disclosure relates to a polypectomy device and method for excision of polyps.
  • a polyp is an abnormal growth of tissue projecting from a mucous membrane. If it is attached to the surface of the narrow elongated stalk is said to be pedunculated polyp. If it is attached without a stalk, it is said to be sessile polyp. Polyps are generally found in the colon, stomach, nose, urinary bladder and uterus. They may also occur elsewhere in the body where there are mucous membrane, including the cervix, vocal folds, and small intestine.
  • the surgical procedure for removing the polyp is generally referred to as a polypectomy, and is generally by endoscopic or surgical procedures. When the location of the polyp permits, the polypectomy is performed as an endoscopic procedure.
  • Colon cancer is leading cause of cancer mortality. Colorectal cancer is preventable by removing premalignant polyps. CRC screening by colonoscopy to detect and removal of premalignant polyps is highly recommended and it is very useful in reducing the incidence and mortality from CRC in past decades. It has pivtol role in prevention of cancer.
  • Polypectomy consists of excision of polyps .Polypectomy techniques are highly variable and depends on polyp morphology and endoscopist preference. Polyps are categorized into four groups depending on their size, diminutive ( ⁇ 5mm), small (6-9mm), large (> 10mm) and gigantic (> 30mm).
  • Polypectomies are either “cold” mechanical cutting or “hot” resection through electrocautery.
  • Various types of devices like snares and forceps are available for performing polypectomies and each of them have their own advantages and disadvantages.
  • jumbo forceps or snare is used for removal of small and diminutive polyps cold biopsy forceps.
  • jumbo forceps or snare is used for large colonic polyps surgery has been considered as mainstay of treatment historically, however it is associated with high complication and morbidity rate and high cost.
  • EMR Endoscopic Mucosal resection
  • ESD Endoscopic Submucosal Dissection
  • Snare polypectomy is preferred for large peduculated polyps and useful in EMR technique.
  • the snare device is guided to the location through an endoscope after which ensnaring of the polyp is done.
  • the snare is tightened around the polyp and through electro cauterization, the polyp is resected with minimal bleeding.
  • forceps are guided endoscopically and sampling or ablation/resection of the polyp is carried out.
  • the process of grasping/snaring the polyp is often difficult and time consuming for the endoscopist particularly when the polyp is located in regions that are hard to access and for trainees and endoscopists who have less expertise.
  • US7819872B2 discloses an endoscopic forceps including an end effector assembly having forceps jaws movable from a first position in spaced relation relative to one another to a second position closer to one another for grasping tissue there between.
  • US9724116B2 discloses an endoscopic forceps includes an elongate shaft defining an instrument axis.
  • An end effector includes first and second forceps jaws each supporting an opposed sealing surface for clamping tissue.
  • US20060025780 pending application discloses a polypectomy instrument for the resection and withdrawal of a polyp tissue from a body lumen. The instrument comprises a dual handle arrangement on a first proximal end of the polypectomy instrument and working channels on a distal end of the dual handle arrangement.
  • Endoscopic polypectomy has witnessed continuous advances because of improvement in technology of endoscopes, endoscopic accessories and techniques.
  • the existing snares consume lot of time to ensnare the polyp particularly if they are large and long pedicle polyps, and located at difficult positions.
  • the snare needs to be exchange with other device that not only prolongs the procedure duration but also consumes crucial time.
  • Certain endoscopic devices comprise a snare cable and grasper to removal polyps.
  • the grasper has a pair of jaws.
  • the snare cable is operably coupled to the grasper jaws.
  • the first step involves shortening the snare cable to position the jaws about the base of the polyp. Thereafter, shortening the cable closes the jaws to remove the polyps.
  • Existing endoscopic devices take a lot of time to remove polyps. Currently used devices are unable to effectively control post polypectomy bleeding. Further, to control post- polypectomy bleeding other accessories like endoclips, Argon Plasma Coagulation (APC) or Coagrasper are often required. Additionally, jaw configuration in conventional endoscopic devices remains an obstacle to the snare cable and does not allow for a loop to encircle the polyp. Therefore, jaw configuration accordingly needs to be modified for efficient polypectomy procedures.
  • An objective of the present disclosure is directed towards the polypectomy device configured to conduct a polypectomy procedure in less time.
  • Another objective of the present disclosure is directed towards the snaring and grasping operations with a single polypectomy device.
  • the polypectomy device comprising a snare cable is routed through the first forceps jaw and the second forceps jaw to form a loop for grasping the polyp.
  • Another objective of the present disclosure directed towards effectively controlling the post polypectomy bleeding by the polypectomy device.
  • Another objective of the present disclosure is directed towards a polypectomy device that reduces the need of another instrument, saves exchange time and completes the entire procedure in a short span of time.
  • Another objective of the present disclosure is directed towards the polypectomy device having forceps’ tip anti-slip facilitates grasping the polyp to provide mechanical tamponade and to isolate vessel from healthy mucosa prior to a thermal application.
  • Another objective of the present disclosure is directed towards the polypectomy device that reduces procedure time.
  • Another objective of the present disclosure is directed towards the polypectomy device that catches the polyp peduncle base irrespective of the size with short span of time, overcome the limitations of snares to use snares to resect large polyps main limitation is to ensnare the snare loop around polyp pedicle, it may consume lot of time and sometimes it may require piecemeal polypectomy. With this device there is no need pass a loop over the polyp, just reaching towards base is enough.
  • Another objective of the present disclosure is directed towards the polypectomy device deals the bleeding source immediately and saves the exchange time of endoscopic device.
  • Another objective of the present disclosure directed towards connecting a snare cable to below tips of the forceps jaws to enhance the performance of endoscopic device.
  • a polypectomy device comprising an endoscopic accessories for use in connection with endoscopic procedures.
  • the endoscopic forceps comprising a first forceps jaw and a second forceps jaw, the first forceps jaw and the second forceps jaw are arranged in opposite each other, each jaw body comprising a zigzag-configured linear shape on inner margin configured to hold a polyp when the first and the second forceps jaws are approximated on either side of the polyp.
  • the polypectomy device comprising a plurality of wires operated to pull the snare cable, whereby the snare cable is configured to capture the polyp and operates the first and second forceps jaws.
  • FIG. 1A is diagram depicting a close up view of distal end of polypectomy device from above wide open forceps jaws assembly with pre loop, in accordance with one or more exemplary embodiments.
  • FIG. IB is diagram depicting a close up view of distal end of polypectomy device from above - forceps jaws assembly without pre loop in open position, in accordance with one or more exemplary embodiments.
  • FIG. 2A is a diagram depicting a close up view distal end of polypectomy device from above where forceps jaws are in approximated position , in accordance with one or more exemplary embodiments.
  • FIG. 2B is a diagram depicting a close up view distal end of polypectomy device from above where forceps jaws are in approximated position and with preloop formation, in accordance with one or more exemplary embodiments..
  • FIG. 3 is a diagram depicting a close-up cross sectional view of the forceps jaws at body level (an end effector), in accordance with one or more exemplary embodiments.
  • FIG. 4 is a diagram depicting a forceps jaws positioning on either side of polyp pedicle, in accordance with one or more exemplary embodiments.
  • FIG. 5A is a diagram depicting a overall side view of polypectomy size with two handles, a jaw assembly and an electric connector, in accordance with one or more exemplary embodiments.
  • FIG. 5B is a diagram depicting an overall side view of polypectomy size with a single handle, a jaw assembly and an electric connector
  • FIG. 6 is a diagram depicting an embodiment of the polypectomy device inserted into colon of the patient, in accordance with one or more exemplary embodiments.
  • FIG. 7 is a diagram depicting an embodiment of the polypectomy device inserted into a nasal cavity with forceps jaws approximated either side of nasal polyp, in accordance with one or more exemplary embodiments.
  • FIG. 8 is a diagram depicting an embodiment of the polypectomy device inserted into a uterine cavity with forceps jaws approximated either side of the uterine polyp, in accordance with one or more exemplary embodiments.
  • FIG. 9 is a flowchart depicting an exemplary method for cutting and sealing the polyp, in accordance with one or more exemplary embodiments.
  • proximal refers to the end of the device that is closer to the endoscopist and the term “distal” refers to the end of the device that is further from the endoscopist .
  • FIG. la and Figure lb are diagrams 100a, 100b depicting the close up views of forceps jaws with pre loop and without pre loop in open position from above distal end of polypectomy device with wide open jaws, in accordance with one or more exemplary embodiments.
  • the polypectomy device 100a, 100b includes an open view of the polypectomy device with forceps jaws in an open configuration.
  • the polypectomy device 100 may be any suitable length and size for accessing various locations throughout the body.
  • the polypectomy device 100 may be configured for removal of suitable types of polyps of any size, or may be configured for general mucosal resection or removal of any suitable tissue mass.
  • the polypectomy device 100 is configured for endoscopic, laparoscopic or transluminal insertion.
  • the polypectomy device 100 is illustrated in a functional position within a conventional endoscope. It should be understood that the use of the polypectomy device 100 is not limited to any specific endoscope design.
  • the polypectomy device 100 includes ensnaring, resection and hemostasis in a single tool, eliminating the need for multiple accessories during the single procedure.
  • the polypectomy device 100 offers flexibility of retrieving transected polyp easily.
  • the polypectomy device 100 includes endoscopic forceps jaws 101a, 101b for use in connection with endoscopic surgical procedures.
  • the endoscopic forceps 101a, 101b also includes an electrosurgical cable (also known as snare cable, 106), both jaws 101a and 101b and snare cable 106 extend out of the distal end of the catheter body 401 (shown in FIG. 2A, FIG. 5A). Both jaws 101a and 101b are operatively connected to body of the catheter at a hinge 121.
  • Each jaw lOla/lOlb includes a base 131, a body 132 and a tip 133. Jaw segment which includes lumens 122a and 122b considered as body of jaw, part of jaw above the body is mentioned as the tip 133, the part of j aw 101 a/ 101 b below the body mentioned as the base 131.
  • both jaws body 132 includes a lumen with/ without an insulation 122a and 122b, which extends from the body 132 and base junction above the level of hinge at the hole 123a and 123 b, it traverses along the body 132, distally towards tip 133 of the jaw lOla/lOlb and lumen 122a and 122b exist at the hole 124a and 124b located at the body 132 and tip junction forceps jaws 101a and 101b.
  • Jaws 101a, 101b are movable and close together in a scissors like movement, and medial surfaces of body 105a and 105b, medial surfaces of tip 125a and 125b are fit together and have grasping faces and helps to hold the pedicle of pedunculated polyp and bleeding spots respectively.
  • the forceps’ tip such as medial surfaces of tips 125a and 125b include anti-slip jaw facilitates grasping the polyp to provide mechanical tamponade and to isolate the vessel from healthy mucosa prior to thermal application.
  • jaw opposing surfaces in the body region of the forceps cusps 101a, 101b may be a bit concave to accommodate the polyp peduncle.
  • the forceps jaws 101a, 101b includes a snare cable 106 which may be operatively connected to the body of catheter 401.
  • the snare cable 106 exists body 401 (shown in FIG. 2A, FIG. 5 A) of the catheter above the level of the hinge 121, after exit snare cable 106 enters the lumen 122a and 122b at the holes 123 and 123b and traverses along the lumen 122a and 122b snare cable 106 again exits the lumen 122a, 122b at the holes 124a and 124b; snare cable 106 forms a loop; However, after exiting at the holes 124a and 124b, apex of the loop may be attached to a small semicircular ridge 126 as depicted in Figure la, over upper jaw to hold the snare cable 106, on traction with mild force it may automatically releases from the ridge, with this arrangement it facilitates pre-loop fixation even before the
  • inverted "Ohm" shaped loop of snare cable 106 by attaching the tip of loop to the small semicircular ridge 126 over the base 131 of the upper jaw lOla/lOlb. By preforming the loop it facilitates polypectomy procedure, in this by capturing peduncle of polyp it automatically forms loop around the peduncle. On pulling the snare cable 106 loop tip disimpacts from the small semicircular ridge 126 and helps to sever the polyp. Even without preformed loop also in open configuration we may push the snare cable 106 against polyp pedicle and simultaneous closure of forceps jaws 101a, 101b leads to capture of the polyp and loop formation. In this position by applying electric current and shortening of loop leads to sever of polyp peduncle.
  • Both snare cable 106 and forceps jaws 101a, 101b may be operatively connected to a source of electrosurgical energy electrosurgical unit (not shown).
  • a source of electrosurgical energy electrosurgical unit not shown.
  • In the polypectomy we try to hold the peduncle of the polyp with both jaws of the forceps 101a, 101b, which helps to capture the polyp and at the same time it forms loop around the pedicle.
  • the mechanical pressure by forceps jaws lOla/lOlb facilitates stabilizing the polyp pedicle and cutting by snare causes the tissue transection which severs the polyp from surface.
  • the polypectomy device 100 may be configured to achieve hemostasis and retrieve entire polyp without requiring any external devices.
  • the forceps jaws 101a andlOlb may be composed of stainless steel or any other suitable material, ceramic, plastic, and so forth. Insulation may be used in lumens 122a and 122b or wherever possible composed of Polytetrafluoroethylene/polyamide blend, fluropolymer, and polyimide and any other suitable material. The insulation may isolate the snare cable 106 from the forceps jaws 101 and 101b.
  • the wires 110 may be composed of an electrically conductive material, such as nichrome or any other suitable material.
  • the wires 110 may get from external source such as ERBE machine or any other source.
  • the both lumens of jaws 122a and 122b includes a friction liner may be composed of nylon or Teflon, which reduces friction generated by the snare cable 106 movement and helps to operate smoothly.
  • the power source may be activated by a foot switch (not shown) or it may be operated by a button or switch located on the catheter or power source.
  • the polypectomy device 100 may include a proximal end and a distal end.
  • the distal end of the polypectomy device 100 includes jaws 101a, 101b and the proximal end of the polypectomy device 100 includes a (central shaft) and handle (shown in FIG. 2).
  • the snare cable 106 extending out of one of forceps jaws 101a and 101b.
  • the first forceps jaw 101a and the second forceps jaw 101b may be arranged in opposite each other.
  • the snare cable 106 may be connected to below tips of the forceps jaws 101a and 101b to enhance the performance of endoscopic device.
  • the snare cable 106 may be routed through the first forceps jaw 101a and the second forceps jaw 101b to form a loop for encircling a polyp stalk from proximal to distal (shown in FIG. 4).
  • the snare cable 106 may be routed through below the tip of the first jaw 101a and the second jaw 101b to form the loop for encircling the polyp.
  • the wires 110 may be internally connected to the snare cable 106.
  • Forceps jaw include a body 132, which provides a structural strength necessary to allow the forceps jaw to grasp the polyp with an appropriate pressure.
  • the endoscopic forceps 101a, 101b may include a zigzag-configured linear shape 105a, 105b. At the tip inner surface of forceps jaws contain linear ridges which facilities to hold the bleeding vessel or bleeding spot.
  • each jaw contains a short canals 11 lx and lily, one opening canal lies near base and upper surface of the jaw, lumen of the canal passes through the body of the jaw proximally and opens at upper surface of the jaw just short of tip of jaws. Both canals and openings are at the same level in both jaws. Snare wire traverses the both canals forms a loop when snare wire is pushed because of wire memory and mechanical force against the pedicle. Loop can be attached small ridge like configuration or partially closed short range over the junction of both jaws or base of the upper jaw with the purpose of engage the tip of the loop, by which it forms a loop above the level of forceps jaws resembling the inverted Ohm symbol.
  • This loop is attached to long cable in the shaft, which starts from a handle, which is connected to electrosurgical unit; by pulling and pushing this handle helps to ensnare the polyp pedicle and by applying electrosurgical current helps to sever the polyp.
  • 110 may be operated to pull the snare cable 106.
  • the snare cable 106 may be configured to capture the polyp.
  • the zigzag- configured inner edge lOla and 10 lb may be configured to hold the polyp.
  • the endoscopic forceps 101a, 101b may be configured to collect the resected polyp.
  • the polypectomy device 100 possibly reduces procedure time.
  • the polypectomy device 100 also catches the polyp peduncle base irrespective of the size with short span of time; with this overcome the limitations of snares -to use snares to resect large polyps main limitation is to ensnare the snare loop around polyp pedicle, it may consume lot of time and sometimes it may require piecemeal polypectomy. With polypectomy device 100 there is no need pass a loop over the polyp, just reaching towards base is enough.
  • the polypectomy device 100 also includes a coagrapser also - we can deal the bleeding source immediately and it saves the exchange time of endoscopic device.
  • FIG. 2A and 2B are schematic diagrams 200a, 200b depicting a closed view of forceps jaws assembly in approximated position from above distal end of the polypectomy device, in accordance with one or more exemplary embodiments.
  • the first forceps jaw 101a and the second forceps jaw 101b may be supported on one end of catheter body 401 by pivot pins (not shown).
  • the first and second forceps jaws 101a and 101b may be in juxtaposed relation to one another and are movable between an open configurations, wherein the polyp may be positioned between forceps jaws 101a and 101b, and a closed configuration, wherein the first and second forceps jaws 101a and 101b grasp onto the polyp during retrieval.
  • Pre loop may be formed by attaching the tip of snare loop semicircular ridge 126 over the forceps jaw base 126 or over hinge site, which holds the tip of snare cable 106 and facilitates inverted loop formation. This pre loop makes polypectomy procedure easier.
  • FIG. 3 is diagram 300 depicting a close-up cross sectional view of the forceps jaws at body level (an end effector), in accordance with one or more exemplary embodiments.
  • the close-up cross sectional view 300 includes the first forceps jaw 101a movably disposed with respect to the second forceps jaw 101b.
  • Each jaw cross section at the level of body 132 is triangle shape with ridged edges at the grasping surface 105a and 105b and smooth external/outer surface.
  • the close-up cross sectional view 300a further includes lumen 122a and 122b with allows the snare cable 106.
  • the level of the canal is the above the level of grasping surface of jaws and after opposing the jaws upper surface looks concave shaped; this shape and level of the lumens 122a and 122b facilitates inadvertent impaction of snare wire loop in between the jaws 101a and 101b.
  • FIG. 4 is a diagram 400 depicting forceps jaws positioning on either side of the polyp pedicle, in accordance with one or more exemplary embodiments.
  • Another embodiment of the polypectomy device is shown as having a unilateral/bilateral forceps jaw arrangement. It is envisioned that when the polypectomy device 400 is in the open condition, the snare cable 106 in inverted loop resembling inverted Ohm shape around the polyp pedicle 403. After close approximation of jaws around the polyp peduncle 403 and simultaneous shortening of snare cable 106 loop by pulling and electrocauterisation leads to severing of polyp.
  • FIG. 5 A is a diagram 500a depicting an embodiment of overall side view of the composite polypectomy device, in accordance with one or more exemplary embodiments.
  • the proximal end of the polypectomy device 500a includes electric connectors 501 and 502 and handles 503 and 504.
  • the electrical connectors 501 and 502 may be configured to connect the catheter to an electric power source.
  • Each handle 503/504 includes cables 505 and 506 and fixed finger holds 507a and 507b in an upper handle 503, the fixed finger holds 508a and 508b in a lower handle 504.
  • the cables 505, 506 may be attached to the electric connectors 501 and 502 and to the handles 503, 504.
  • These handles 503, 504 may be moved as separate units over center handle/ bar509.
  • the upper handle 503 may be operated to open and close the forceps jaws, which helps to captures the polyp peduncle, helps to achieve hemostasis by holding and electrocoagulating bleeding spot, and also helps to retrieve polyp.
  • the lower handle 506 may be configured to pull and push the snare cable 106 and activating power source it helps to narrow the snare loop and sever the polyp.
  • FIG. 5B is a diagram 500b depicting an embodiment of overall side view of composite polypectomy device, in accordance with one or more exemplary embodiments.
  • the proximal end of the polypectomy device 500b includes an electric connector 501/502, a single handle 503/504, and the jaw assembly.
  • the handle 503/504 includes cables 601 and 602 and fixed finger holds 507b/508b and 507a/508a.
  • the cables 601 and 602 may be attached to the electric connector 501/502 and to the handle 503/504.
  • the handle 503/504 may be moved as a separate unit over center handle/bar 509.
  • the handle 503/504 may be operated to open and close the forceps jaws, which helps to capture the polyp peduncle, helps to achieve hemostasis by holding and electro coagulating bleeding spot, and also helps to retrieve polyp.
  • the handle 503/504 may be configured to pull and push the snare cable 106 and activating power source it helps to narrow the snare loop and sever the polyp.
  • the composite polypectomy device 100 includes the snare cable 106 and the forceps 101 a and 101b is disclosed, wherein the composite polypectomy device 100 has the longitudinal tubular flexible catheter body 401 which extends from the handle 503/504 to the forceps jaws 101a and 101b.
  • the longitudinal tubular flexible catheter body 401 has a first conduit and a second conduit that are hollow and are longitudinally parallel to each other for accommodating the snare cable 106 and cables to forceps jaws respectively.
  • the forceps jaws 101a and 101b are operatively connected to forceps handle 503/504, by the longitudinal cable 505 enclosed within a longitudinal flexible tubular cable sheath 512.
  • the longitudinal cable 505 at its proximal end may be coupled to the forceps handle 503/504 and at its distal end may be connected to a base of forceps jaws 132.
  • the forceps includes a pair of jaws 101a and 101b particularly opposed to each other.
  • the forceps handle 503 when operated causes them to and fro movement of the cable 505 leading to pushing up and extension of the jaws as depicted in Figure la and Figure lb or pulling down and retraction of the jaws as depicted in Figure 2a and 2b.
  • the handle 504 operatively connected to snare loop 106 via the snare cable 506. By to and fro movement of the handle 504 helps to ensnare and sever of polyp by mechanical and/or electro cauterization.
  • the snare loop and the forceps of the composite polypectomy device 100 can be used for “hot” cauterization as well as “cold” mechanical cutting.
  • the polypectomy device can be used for collection of samples for biopsy purposes or for resection/ablation of polyps.
  • FIG. 6 is a diagram 600 depicting an embodiment of the polypectomy device inserted into colon of the patient, in accordance with one or more exemplary embodiments.
  • endoscopist inserts the polypectomy device into working channel of the endoscope.
  • the endoscopist moves the distal end of the catheter body 401 toward the polyp 603 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 603, this maneuver forms a loop around the polyp peduncle 603, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
  • the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 603.
  • bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy.
  • retrieve resected polyp 603 by holding with both jaws of forceps 101a, 101b.
  • FIG. 7 is a diagram 700 depicting an embodiment of the polypectomy device inserted into a nasal cavity with forceps jaws approximated either side of nasal polyp, in accordance with one or more exemplary embodiments.
  • Nasal polyps 703 may be removed with the polypectomy device, after inserting nasal endoscope into nasal cavities or sinuses, once polyp 703 is located, the endoscopist inserts the polypectomy device into working channel of the endoscope.
  • the endoscopist moves the distal end of the catheter body 401 toward the polyp 703 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 703, this maneuver forms a loop around the polyp peduncle 703, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
  • the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 703.
  • bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy.
  • retrieve resected polyp 703 by holding with both jaws of forceps 101a, 101b.
  • FIG. 8 is a diagram depicting an embodiment of the polypectomy device inserted into a uterine cavity with forceps jaws approximated either side of the uterine polyp, in accordance with one or more exemplary embodiments.
  • Uterine or endometrial polyps 803 may be removed with the polypectomy device; after inserting endoscope into uterine cavity, once polyp is located, the endoscopist inserts the polypectomy device into working channel of the endoscope.
  • the endoscopist moves the distal end of the catheter body 401 toward the polyp 803 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 803, this maneuver forms a loop around the polyp peduncle 803, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
  • the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 803.
  • bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy.
  • retrieve resected polyp 803 by holding with both jaws of forceps 101a, 101b.
  • FIG. 9 is a flowchart 900 depicting an exemplary method for cutting and sealing the polyp, in accordance with one or more exemplary embodiments.
  • the method 900 is carried out in the context of the details of FIG. 1A, FIG. IB, FIG. 2 A, FIG. 2B, FIG. 3, FIG. 4, FIG. 5A, FIG. 5B, FIG. 6, FIG. 7, and FIG. 8.
  • the method 900 is carried out in any desired environment. Further, the aforementioned definitions are equally applied to the description below.
  • the method commences at step 902, inserting a polypectomy device into working channel of an endoscope by a user after polyp peduncle is located on a part of the body. Thereafter, at step 904, moving a distal end of a catheter body towards the polyp and opens both jaws of forceps to capture either side of the polyp peduncle. Thereafter, at step 906, forming a semicircular/ partially closed loop for encircling the polyp peduncle by a snare cable through the forceps jaws.
  • step 908 activating the snare cable and shortening the snare loop/drawing snare cable proximally by pulling a handle helps to cut and seal the tissue and severing the polyp peduncle once the polyp peduncle is approximated/encompassed by the forceps jaws.
  • step 910 cutting and sealing the polyp between the forceps jaws.

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Abstract

Exemplary embodiments of the present disclosure directed towards a polypectomy device for excision of polyps, comprising: an endoscopic forceps comprising a first forceps jaw and a second forceps jaw, the forceps jaws are rotatable connected to a catheter body, the catheter body moves towards a polyp peduncle and opens the forceps jaws to capture either side of the polyp peduncle; and a snare cable is routed through the forceps jaws to form a loop for grasping polyp peduncle, the snare cable operatively connected to the catheter body, forceps jaws configured to hold the polyp peduncle after pulling snare cable and applying electrosurgical current, the forceps jaws configured to facilitate stabilizing the polyp pedicle and cut the polyp pedicle by snare cable, forceps jaws configured to collect resected polyp, the forceps jaws comprising forceps tips configured to hold a bleeding spot to control post polypectomy bleed and apply electro cauterization.

Description

“POLYPECTOMY DEVICE FOR EXCISION OF POLYPS AND METHOD
EMPLOYED THEREOF”
TECHNICAL FIELD
[001] The disclosed subject matter relates generally to surgical/endoscopic instruments. More particularly, the present disclosure relates to a polypectomy device and method for excision of polyps.
BACKGROUND
[002] Removal of unhealthy internal tissue for diagnostic or other reasons by the use of various apparatus and techniques is known in the art. A polyp is an abnormal growth of tissue projecting from a mucous membrane. If it is attached to the surface of the narrow elongated stalk is said to be pedunculated polyp. If it is attached without a stalk, it is said to be sessile polyp. Polyps are generally found in the colon, stomach, nose, urinary bladder and uterus. They may also occur elsewhere in the body where there are mucous membrane, including the cervix, vocal folds, and small intestine. The surgical procedure for removing the polyp is generally referred to as a polypectomy, and is generally by endoscopic or surgical procedures. When the location of the polyp permits, the polypectomy is performed as an endoscopic procedure.
[003] Colon cancer (CRC) is leading cause of cancer mortality. Colorectal cancer is preventable by removing premalignant polyps. CRC screening by colonoscopy to detect and removal of premalignant polyps is highly recommended and it is very useful in reducing the incidence and mortality from CRC in past decades. It has pivtol role in prevention of cancer. Polypectomy consists of excision of polyps .Polypectomy techniques are highly variable and depends on polyp morphology and endoscopist preference. Polyps are categorized into four groups depending on their size, diminutive (<5mm), small (6-9mm), large (> 10mm) and gigantic (> 30mm).
[004] Polypectomies are either “cold” mechanical cutting or “hot” resection through electrocautery. Various types of devices like snares and forceps are available for performing polypectomies and each of them have their own advantages and disadvantages. For removal of small and diminutive polyps cold biopsy forceps, jumbo forceps or snare is used. For large colonic polyps surgery has been considered as mainstay of treatment historically, however it is associated with high complication and morbidity rate and high cost. Endoscopic Mucosal resection (EMR) and Endoscopic Submucosal Dissection (ESD) polyps are preferred choices. Snare polypectomy is preferred for large peduculated polyps and useful in EMR technique.
[005] During polypectomy with a snare, the snare device is guided to the location through an endoscope after which ensnaring of the polyp is done. In hot snare technique, the snare is tightened around the polyp and through electro cauterization, the polyp is resected with minimal bleeding. In the same way, forceps are guided endoscopically and sampling or ablation/resection of the polyp is carried out. But the process of grasping/snaring the polyp is often difficult and time consuming for the endoscopist particularly when the polyp is located in regions that are hard to access and for trainees and endoscopists who have less expertise.
[006] Polypectomy associated with various complications like GI bleeding and perforation. Bleeding is most common complication, it ranges from 0.3 to 2 % for diminutive polyp and 1-10% for large polyps. Pedunculated polyps are supplied by multiple vessels and increased risk of bleeding. Multiple techniques are available to control or prevent post polypectomy bleeding like endoclip application, detachable snare around stalk, injection of epinephrine, argon plasma coagulation and using devices like coagrasper. In all these procedures you need to exchange with other device, it consumes crucial time. US7819872B2 discloses an endoscopic forceps including an end effector assembly having forceps jaws movable from a first position in spaced relation relative to one another to a second position closer to one another for grasping tissue there between. US9724116B2 discloses an endoscopic forceps includes an elongate shaft defining an instrument axis. An end effector includes first and second forceps jaws each supporting an opposed sealing surface for clamping tissue. US20060025780 pending application discloses a polypectomy instrument for the resection and withdrawal of a polyp tissue from a body lumen. The instrument comprises a dual handle arrangement on a first proximal end of the polypectomy instrument and working channels on a distal end of the dual handle arrangement. [007] Endoscopic polypectomy has witnessed continuous advances because of improvement in technology of endoscopes, endoscopic accessories and techniques. The existing snares consume lot of time to ensnare the polyp particularly if they are large and long pedicle polyps, and located at difficult positions. Sometimes, there is a need to perform piecemeal polypectomy that is time consuming and also increases the chance of bleeding. In case of post-polypectomy bleed, the snare needs to be exchange with other device that not only prolongs the procedure duration but also consumes crucial time. Certain endoscopic devices comprise a snare cable and grasper to removal polyps. The grasper has a pair of jaws. The snare cable is operably coupled to the grasper jaws. Shortening the snare cable positions the jaws about the base of the polyp and further shortening the cable closes the jaws and in few devices heating element will be there which helps to cauterize and resect polyps. In order to enable removal of the polyps, the following steps are performed. The first step involves shortening the snare cable to position the jaws about the base of the polyp. Thereafter, shortening the cable closes the jaws to remove the polyps. Existing endoscopic devices take a lot of time to remove polyps. Currently used devices are unable to effectively control post polypectomy bleeding. Further, to control post- polypectomy bleeding other accessories like endoclips, Argon Plasma Coagulation (APC) or Coagrasper are often required. Additionally, jaw configuration in conventional endoscopic devices remains an obstacle to the snare cable and does not allow for a loop to encircle the polyp. Therefore, jaw configuration accordingly needs to be modified for efficient polypectomy procedures.
[008] In the light of aforementioned discussion, there exists a need for a certain polypectomy device that would overcome the above-mentioned challenges.
SUMMARY
[009] The following presents a simplified summary of the disclosure in order to provide a basic understanding to the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later. [0010] Exemplary embodiments of the present disclosure directed towards a polypectomy device and a method for excision of polyps.
[0011] An objective of the present disclosure is directed towards the polypectomy device configured to conduct a polypectomy procedure in less time.
[0012] Another objective of the present disclosure is directed towards the snaring and grasping operations with a single polypectomy device.
[0013] According to another exemplary aspect, the polypectomy device comprising a snare cable is routed through the first forceps jaw and the second forceps jaw to form a loop for grasping the polyp.
[0014] Another objective of the present disclosure directed towards effectively controlling the post polypectomy bleeding by the polypectomy device.
[0015] Another objective of the present disclosure is directed towards a polypectomy device that reduces the need of another instrument, saves exchange time and completes the entire procedure in a short span of time.
[0016] Another objective of the present disclosure is directed towards the polypectomy device having forceps’ tip anti-slip facilitates grasping the polyp to provide mechanical tamponade and to isolate vessel from healthy mucosa prior to a thermal application.
[0017] Another objective of the present disclosure is directed towards the polypectomy device that reduces procedure time.
[0018] Another objective of the present disclosure is directed towards the polypectomy device that catches the polyp peduncle base irrespective of the size with short span of time, overcome the limitations of snares to use snares to resect large polyps main limitation is to ensnare the snare loop around polyp pedicle, it may consume lot of time and sometimes it may require piecemeal polypectomy. With this device there is no need pass a loop over the polyp, just reaching towards base is enough.
[0019] Another objective of the present disclosure is directed towards the polypectomy device deals the bleeding source immediately and saves the exchange time of endoscopic device.
[0020] Another objective of the present disclosure directed towards connecting a snare cable to below tips of the forceps jaws to enhance the performance of endoscopic device.
[0021] According to an exemplary aspect, a polypectomy device comprising an endoscopic accessories for use in connection with endoscopic procedures.
[0022] According to another exemplary aspect, the endoscopic forceps comprising a first forceps jaw and a second forceps jaw, the first forceps jaw and the second forceps jaw are arranged in opposite each other, each jaw body comprising a zigzag-configured linear shape on inner margin configured to hold a polyp when the first and the second forceps jaws are approximated on either side of the polyp. Tip of forceps jaws inner ridged surface with anti-slip design to help grasp vessel and coagulate to prevent bleeding.
[0023] According to another exemplary aspect, the polypectomy device comprising a plurality of wires operated to pull the snare cable, whereby the snare cable is configured to capture the polyp and operates the first and second forceps jaws.
BRIEF DESCRIPTION OF DRAWINGS
[0024] FIG. 1A is diagram depicting a close up view of distal end of polypectomy device from above wide open forceps jaws assembly with pre loop, in accordance with one or more exemplary embodiments.
[0025] FIG. IB is diagram depicting a close up view of distal end of polypectomy device from above - forceps jaws assembly without pre loop in open position, in accordance with one or more exemplary embodiments. [0026] FIG. 2A is a diagram depicting a close up view distal end of polypectomy device from above where forceps jaws are in approximated position , in accordance with one or more exemplary embodiments.
[0027] FIG. 2B is a diagram depicting a close up view distal end of polypectomy device from above where forceps jaws are in approximated position and with preloop formation, in accordance with one or more exemplary embodiments..
[0028] FIG. 3 is a diagram depicting a close-up cross sectional view of the forceps jaws at body level (an end effector), in accordance with one or more exemplary embodiments.
[0029] FIG. 4 is a diagram depicting a forceps jaws positioning on either side of polyp pedicle, in accordance with one or more exemplary embodiments.
[0030] FIG. 5A is a diagram depicting a overall side view of polypectomy size with two handles, a jaw assembly and an electric connector, in accordance with one or more exemplary embodiments.
[0031] FIG. 5B is a diagram depicting an overall side view of polypectomy size with a single handle, a jaw assembly and an electric connector
[0032] FIG. 6 is a diagram depicting an embodiment of the polypectomy device inserted into colon of the patient, in accordance with one or more exemplary embodiments.
[0033] FIG. 7 is a diagram depicting an embodiment of the polypectomy device inserted into a nasal cavity with forceps jaws approximated either side of nasal polyp, in accordance with one or more exemplary embodiments.
[0034] FIG. 8 is a diagram depicting an embodiment of the polypectomy device inserted into a uterine cavity with forceps jaws approximated either side of the uterine polyp, in accordance with one or more exemplary embodiments. [0035] FIG. 9 is a flowchart depicting an exemplary method for cutting and sealing the polyp, in accordance with one or more exemplary embodiments.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0036] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[0037] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.
[0038] As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the device that is closer to the endoscopist and the term “distal” refers to the end of the device that is further from the endoscopist .
[0039] Referring to FIG. la and Figure lb are diagrams 100a, 100b depicting the close up views of forceps jaws with pre loop and without pre loop in open position from above distal end of polypectomy device with wide open jaws, in accordance with one or more exemplary embodiments. The polypectomy device 100a, 100b includes an open view of the polypectomy device with forceps jaws in an open configuration. The polypectomy device 100 may be any suitable length and size for accessing various locations throughout the body. The polypectomy device 100 may be configured for removal of suitable types of polyps of any size, or may be configured for general mucosal resection or removal of any suitable tissue mass. Preferably, the polypectomy device 100 is configured for endoscopic, laparoscopic or transluminal insertion. The polypectomy device 100 is illustrated in a functional position within a conventional endoscope. It should be understood that the use of the polypectomy device 100 is not limited to any specific endoscope design. The polypectomy device 100 includes ensnaring, resection and hemostasis in a single tool, eliminating the need for multiple accessories during the single procedure. The polypectomy device 100 offers flexibility of retrieving transected polyp easily. The polypectomy device 100 includes endoscopic forceps jaws 101a, 101b for use in connection with endoscopic surgical procedures. The endoscopic forceps 101a, 101b also includes an electrosurgical cable (also known as snare cable, 106), both jaws 101a and 101b and snare cable 106 extend out of the distal end of the catheter body 401 (shown in FIG. 2A, FIG. 5A). Both jaws 101a and 101b are operatively connected to body of the catheter at a hinge 121. Each jaw lOla/lOlb includes a base 131, a body 132 and a tip 133. Jaw segment which includes lumens 122a and 122b considered as body of jaw, part of jaw above the body is mentioned as the tip 133, the part of j aw 101 a/ 101 b below the body mentioned as the base 131. However, it should be noted one of the jaw lOla/lOlb may be fixed to the catheter body 401 (shown in FIG. 2A, FIG. 5A) or otherwise rotatable and secured to catheter body 401 (shown in FIG. 2A, FIG. 5 A). Both jaws body 132 includes a lumen with/ without an insulation 122a and 122b, which extends from the body 132 and base junction above the level of hinge at the hole 123a and 123 b, it traverses along the body 132, distally towards tip 133 of the jaw lOla/lOlb and lumen 122a and 122b exist at the hole 124a and 124b located at the body 132 and tip junction forceps jaws 101a and 101b.
[0040] Jaws 101a, 101b are movable and close together in a scissors like movement, and medial surfaces of body 105a and 105b, medial surfaces of tip 125a and 125b are fit together and have grasping faces and helps to hold the pedicle of pedunculated polyp and bleeding spots respectively. The forceps’ tip such as medial surfaces of tips 125a and 125b include anti-slip jaw facilitates grasping the polyp to provide mechanical tamponade and to isolate the vessel from healthy mucosa prior to thermal application. In an embodiment of the present disclosure, jaw opposing surfaces in the body region of the forceps cusps 101a, 101b may be a bit concave to accommodate the polyp peduncle. [0041] The forceps jaws 101a, 101b includes a snare cable 106 which may be operatively connected to the body of catheter 401. The snare cable 106 exists body 401 (shown in FIG. 2A, FIG. 5 A) of the catheter above the level of the hinge 121, after exit snare cable 106 enters the lumen 122a and 122b at the holes 123 and 123b and traverses along the lumen 122a and 122b snare cable 106 again exits the lumen 122a, 122b at the holes 124a and 124b; snare cable 106 forms a loop; However, after exiting at the holes 124a and 124b, apex of the loop may be attached to a small semicircular ridge 126 as depicted in Figure la, over upper jaw to hold the snare cable 106, on traction with mild force it may automatically releases from the ridge, with this arrangement it facilitates pre-loop fixation even before the insertion of device; it forms a inverted "ohm" shaped loop depicted in Figure 2b. We may create inverted "Ohm" shaped loop of snare cable 106 by attaching the tip of loop to the small semicircular ridge 126 over the base 131 of the upper jaw lOla/lOlb. By preforming the loop it facilitates polypectomy procedure, in this by capturing peduncle of polyp it automatically forms loop around the peduncle. On pulling the snare cable 106 loop tip disimpacts from the small semicircular ridge 126 and helps to sever the polyp. Even without preformed loop also in open configuration we may push the snare cable 106 against polyp pedicle and simultaneous closure of forceps jaws 101a, 101b leads to capture of the polyp and loop formation. In this position by applying electric current and shortening of loop leads to sever of polyp peduncle.
[0042] Both snare cable 106 and forceps jaws 101a, 101b may be operatively connected to a source of electrosurgical energy electrosurgical unit (not shown). In the polypectomy we try to hold the peduncle of the polyp with both jaws of the forceps 101a, 101b, which helps to capture the polyp and at the same time it forms loop around the pedicle. In this position we pull the snare cable 106 and apply electrosurgical current. The mechanical pressure by forceps jaws lOla/lOlb facilitates stabilizing the polyp pedicle and cutting by snare causes the tissue transection which severs the polyp from surface. In case of post polypectomy bleed which may be controlled holding the bleeding spot with forceps jaw tips 133 and applying electro cauterisation. The polypectomy device 100 may be configured to achieve hemostasis and retrieve entire polyp without requiring any external devices. [0043] The forceps jaws 101a andlOlb may be composed of stainless steel or any other suitable material, ceramic, plastic, and so forth. Insulation may be used in lumens 122a and 122b or wherever possible composed of Polytetrafluoroethylene/polyamide blend, fluropolymer, and polyimide and any other suitable material. The insulation may isolate the snare cable 106 from the forceps jaws 101 and 101b. The wires 110 may be composed of an electrically conductive material, such as nichrome or any other suitable material. The wires 110 may get from external source such as ERBE machine or any other source. The both lumens of jaws 122a and 122b includes a friction liner may be composed of nylon or Teflon, which reduces friction generated by the snare cable 106 movement and helps to operate smoothly. In use, the power source may be activated by a foot switch (not shown) or it may be operated by a button or switch located on the catheter or power source.
[0044] The polypectomy device 100 may include a proximal end and a distal end. The endoscopic forceps jaws 101a, 101b, a snare cable 106, and wires (110 ) The distal end of the polypectomy device 100 includes jaws 101a, 101b and the proximal end of the polypectomy device 100 includes a (central shaft) and handle (shown in FIG. 2). The snare cable 106 extending out of one of forceps jaws 101a and 101b. The first forceps jaw 101a and the second forceps jaw 101b may be arranged in opposite each other. The snare cable 106 may be connected to below tips of the forceps jaws 101a and 101b to enhance the performance of endoscopic device. The snare cable 106 may be routed through the first forceps jaw 101a and the second forceps jaw 101b to form a loop for encircling a polyp stalk from proximal to distal (shown in FIG. 4). The snare cable 106 may be routed through below the tip of the first jaw 101a and the second jaw 101b to form the loop for encircling the polyp. The wires 110 may be internally connected to the snare cable 106.
[0045] An open configuration of the polypectomy device for receiving polyps’ tissue between the first forceps jaw 101a and the second forceps jaw 101b. Forceps jaw include a body 132, which provides a structural strength necessary to allow the forceps jaw to grasp the polyp with an appropriate pressure. The endoscopic forceps 101a, 101b may include a zigzag-configured linear shape 105a, 105b. At the tip inner surface of forceps jaws contain linear ridges which facilities to hold the bleeding vessel or bleeding spot. Within the body of each jaw contains a short canals 11 lx and lily, one opening canal lies near base and upper surface of the jaw, lumen of the canal passes through the body of the jaw proximally and opens at upper surface of the jaw just short of tip of jaws. Both canals and openings are at the same level in both jaws. Snare wire traverses the both canals forms a loop when snare wire is pushed because of wire memory and mechanical force against the pedicle. Loop can be attached small ridge like configuration or partially closed short range over the junction of both jaws or base of the upper jaw with the purpose of engage the tip of the loop, by which it forms a loop above the level of forceps jaws resembling the inverted Ohm symbol. This loop is attached to long cable in the shaft, which starts from a handle, which is connected to electrosurgical unit; by pulling and pushing this handle helps to ensnare the polyp pedicle and by applying electrosurgical current helps to sever the polyp. 110 may be operated to pull the snare cable 106. The snare cable 106 may be configured to capture the polyp. The zigzag- configured inner edge lOla and 10 lb may be configured to hold the polyp. The endoscopic forceps 101a, 101b may be configured to collect the resected polyp.
[0046] The polypectomy device 100 possibly reduces procedure time. The polypectomy device 100 also catches the polyp peduncle base irrespective of the size with short span of time; with this overcome the limitations of snares -to use snares to resect large polyps main limitation is to ensnare the snare loop around polyp pedicle, it may consume lot of time and sometimes it may require piecemeal polypectomy. With polypectomy device 100 there is no need pass a loop over the polyp, just reaching towards base is enough. The polypectomy device 100 also includes a coagrapser also - we can deal the bleeding source immediately and it saves the exchange time of endoscopic device.
[0047] Referring to FIG. 2A and 2B are schematic diagrams 200a, 200b depicting a closed view of forceps jaws assembly in approximated position from above distal end of the polypectomy device, in accordance with one or more exemplary embodiments. The first forceps jaw 101a and the second forceps jaw 101b may be supported on one end of catheter body 401 by pivot pins (not shown). The first and second forceps jaws 101a and 101b may be in juxtaposed relation to one another and are movable between an open configurations, wherein the polyp may be positioned between forceps jaws 101a and 101b, and a closed configuration, wherein the first and second forceps jaws 101a and 101b grasp onto the polyp during retrieval. [0048] As shown in FIG. 2B: the closed view 200b from above of the polypectomy device with forceps jaws in a closed configuration with pre-loop formation. Pre loop may be formed by attaching the tip of snare loop semicircular ridge 126 over the forceps jaw base 126 or over hinge site, which holds the tip of snare cable 106 and facilitates inverted loop formation. This pre loop makes polypectomy procedure easier.
[0049] Referring to FIG. 3 is diagram 300 depicting a close-up cross sectional view of the forceps jaws at body level (an end effector), in accordance with one or more exemplary embodiments. (The end effector). The close-up cross sectional view 300 includes the first forceps jaw 101a movably disposed with respect to the second forceps jaw 101b. Each jaw cross section at the level of body 132, is triangle shape with ridged edges at the grasping surface 105a and 105b and smooth external/outer surface. The close-up cross sectional view 300a further includes lumen 122a and 122b with allows the snare cable 106. The level of the canal is the above the level of grasping surface of jaws and after opposing the jaws upper surface looks concave shaped; this shape and level of the lumens 122a and 122b facilitates inadvertent impaction of snare wire loop in between the jaws 101a and 101b.
[0050] Referring to FIG. 4 is a diagram 400 depicting forceps jaws positioning on either side of the polyp pedicle, in accordance with one or more exemplary embodiments. Another embodiment of the polypectomy device is shown as having a unilateral/bilateral forceps jaw arrangement. It is envisioned that when the polypectomy device 400 is in the open condition, the snare cable 106 in inverted loop resembling inverted Ohm shape around the polyp pedicle 403. After close approximation of jaws around the polyp peduncle 403 and simultaneous shortening of snare cable 106 loop by pulling and electrocauterisation leads to severing of polyp.
[0051] Referring to Figure 5 A is a diagram 500a depicting an embodiment of overall side view of the composite polypectomy device, in accordance with one or more exemplary embodiments. The proximal end of the polypectomy device 500a includes electric connectors 501 and 502 and handles 503 and 504. The electrical connectors 501 and 502 may be configured to connect the catheter to an electric power source. Each handle 503/504 includes cables 505 and 506 and fixed finger holds 507a and 507b in an upper handle 503, the fixed finger holds 508a and 508b in a lower handle 504. The cables 505, 506 may be attached to the electric connectors 501 and 502 and to the handles 503, 504. These handles 503, 504 may be moved as separate units over center handle/ bar509. The upper handle 503 may be operated to open and close the forceps jaws, which helps to captures the polyp peduncle, helps to achieve hemostasis by holding and electrocoagulating bleeding spot, and also helps to retrieve polyp. The lower handle 506 may be configured to pull and push the snare cable 106 and activating power source it helps to narrow the snare loop and sever the polyp.
[0052] Referring to FIG. 5B is a diagram 500b depicting an embodiment of overall side view of composite polypectomy device, in accordance with one or more exemplary embodiments. The proximal end of the polypectomy device 500b includes an electric connector 501/502, a single handle 503/504, and the jaw assembly. The handle 503/504 includes cables 601 and 602 and fixed finger holds 507b/508b and 507a/508a. The cables 601 and 602 may be attached to the electric connector 501/502 and to the handle 503/504. The handle 503/504 may be moved as a separate unit over center handle/bar 509. The handle 503/504 may be operated to open and close the forceps jaws, which helps to capture the polyp peduncle, helps to achieve hemostasis by holding and electro coagulating bleeding spot, and also helps to retrieve polyp. The handle 503/504 may be configured to pull and push the snare cable 106 and activating power source it helps to narrow the snare loop and sever the polyp.
[0053] In accordance with a non-limiting exemplary embodiment of the present disclosure, the composite polypectomy device 100 includes the snare cable 106 and the forceps 101 a and 101b is disclosed, wherein the composite polypectomy device 100 has the longitudinal tubular flexible catheter body 401 which extends from the handle 503/504 to the forceps jaws 101a and 101b. The longitudinal tubular flexible catheter body 401 has a first conduit and a second conduit that are hollow and are longitudinally parallel to each other for accommodating the snare cable 106 and cables to forceps jaws respectively.
[0054] According to a non-limiting exemplary embodiment of the present disclosure, the forceps jaws 101a and 101b are operatively connected to forceps handle 503/504, by the longitudinal cable 505 enclosed within a longitudinal flexible tubular cable sheath 512. The longitudinal cable 505 at its proximal end may be coupled to the forceps handle 503/504 and at its distal end may be connected to a base of forceps jaws 132. The forceps includes a pair of jaws 101a and 101b particularly opposed to each other. The forceps handle 503 when operated causes them to and fro movement of the cable 505 leading to pushing up and extension of the jaws as depicted in Figure la and Figure lb or pulling down and retraction of the jaws as depicted in Figure 2a and 2b. Similarly, the handle 504 operatively connected to snare loop 106 via the snare cable 506. By to and fro movement of the handle 504 helps to ensnare and sever of polyp by mechanical and/or electro cauterization.
[0055] In accordance with a non-limiting exemplary embodiment of the present disclosure, the snare loop and the forceps of the composite polypectomy device 100 can be used for “hot” cauterization as well as “cold” mechanical cutting. The polypectomy device can be used for collection of samples for biopsy purposes or for resection/ablation of polyps.
[0056] Referring to FIG. 6 is a diagram 600 depicting an embodiment of the polypectomy device inserted into colon of the patient, in accordance with one or more exemplary embodiments. By inserting colonoscope through anal canal we do colonoscopy, on screening for colonic polyps, if any polyp 603 found, endoscopist inserts the polypectomy device into working channel of the endoscope. The endoscopist moves the distal end of the catheter body 401 toward the polyp 603 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 603, this maneuver forms a loop around the polyp peduncle 603, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
[0057] Once the polyp peduncle 603 is approximated/ encompassed by both jaws of forceps 101a, 101b and snare loop, the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 603. In case of post polypectomy bleed, immediately, bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy. After polypectomy, retrieve resected polyp 603 by holding with both jaws of forceps 101a, 101b. [0058] Referring to Figure 7 is a diagram 700 depicting an embodiment of the polypectomy device inserted into a nasal cavity with forceps jaws approximated either side of nasal polyp, in accordance with one or more exemplary embodiments. Nasal polyps 703 may be removed with the polypectomy device, after inserting nasal endoscope into nasal cavities or sinuses, once polyp 703 is located, the endoscopist inserts the polypectomy device into working channel of the endoscope. The endoscopist moves the distal end of the catheter body 401 toward the polyp 703 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 703, this maneuver forms a loop around the polyp peduncle 703, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
[0059] Once the polyp peduncle 703 is approximated/ encompassed by both jaws of forceps 101a, 101b and snare loop, the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 703. In case of post polypectomy bleed, immediately, bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy. After polypectomy, retrieve resected polyp 703 by holding with both jaws of forceps 101a, 101b.
[0060] Referring to FIG. 8 is a diagram depicting an embodiment of the polypectomy device inserted into a uterine cavity with forceps jaws approximated either side of the uterine polyp, in accordance with one or more exemplary embodiments. Uterine or endometrial polyps 803 may be removed with the polypectomy device; after inserting endoscope into uterine cavity, once polyp is located, the endoscopist inserts the polypectomy device into working channel of the endoscope. The endoscopist moves the distal end of the catheter body 401 toward the polyp 803 and opens the both jaws of forceps 101a, 101b to capture either side of polyp peduncle 803, this maneuver forms a loop around the polyp peduncle 803, if necessary manual rotation of the catheter body 401 is accomplished by rotation of the handle 503/504.
[0061] Once the polyp peduncle 803 is approximated/encompassed by both jaws of forceps 101a, 101b and snare loop, the endoscopist activates the snare cable 106 trigger and shortening the snare loop/ drawing snare cable 106 proximally by pulling the handle 503/504 helps to cut and seal the tissue and severing the polyp 803. In case of post polypectomy bleed, immediately, bleeding spots or bleeding vessels may be identified and coagulated with by holding tip of forceps cusps 101a, 101b and activating electric energy. After polypectomy, retrieve resected polyp 803 by holding with both jaws of forceps 101a, 101b.
[0062] Similar procedures may be performed in other parts of the body where polyps or other abnormal tissue growth like colon polyps, nasal polyps, and uterine polyps which may be readily adapted to other conditions. Thus, while the preferred embodiments of the devices and methods have been described in reference to the environment in which they are developed, they are merely illustrative of the principles of the inventions. Other embodiments and configurations may be devised without departing from spirit of the inventions and the scope of appended claims.
[0063] Referring to FIG. 9 is a flowchart 900 depicting an exemplary method for cutting and sealing the polyp, in accordance with one or more exemplary embodiments. As an option, the method 900 is carried out in the context of the details of FIG. 1A, FIG. IB, FIG. 2 A, FIG. 2B, FIG. 3, FIG. 4, FIG. 5A, FIG. 5B, FIG. 6, FIG. 7, and FIG. 8. However, the method 900 is carried out in any desired environment. Further, the aforementioned definitions are equally applied to the description below.
[0064] The method commences at step 902, inserting a polypectomy device into working channel of an endoscope by a user after polyp peduncle is located on a part of the body. Thereafter, at step 904, moving a distal end of a catheter body towards the polyp and opens both jaws of forceps to capture either side of the polyp peduncle. Thereafter, at step 906, forming a semicircular/ partially closed loop for encircling the polyp peduncle by a snare cable through the forceps jaws. Thereafter, at step 908, activating the snare cable and shortening the snare loop/drawing snare cable proximally by pulling a handle helps to cut and seal the tissue and severing the polyp peduncle once the polyp peduncle is approximated/encompassed by the forceps jaws. Thereafter, at step 910, cutting and sealing the polyp between the forceps jaws.
[0065] More illustrative information will now be set forth regarding various optional architectures and uses in which the foregoing method may or may not be implemented, as per the desires of the auto system/user. It should be strongly noted that the following information is set forth for illustrative purposes and should not be construed as limiting in any manner. Any of the following features may be optionally incorporated with or without the exclusion of other features described.
[0066] Furthermore, the described features, structures, or characteristics of the disclosure may be combined in any suitable manner in one or more embodiments. In the above description, numerous specific details are provided such as examples of programming, software modules, user selections, network transactions, database queries, database structures, hardware modules, hardware circuits, hardware chips, etc., to provide a thorough understanding of embodiments of the disclosure.
[0067] Thus the scope of the present disclosure is defined by the appended claims and includes both combinations and sub-combinations of the various features described herein above as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description

Claims

CLAIMS We claim:
1. A polypectomy device for excision of polyps, comprising: an endoscopic forceps comprising a first forceps jaw and a second forceps jaw, whereby the first forceps jaw and the second forceps jaw are rotatable connected to a catheter body, the catheter body configured to move towards a polyp peduncle and opens the first forceps jaw and the second forceps jaw to capture either side of the polyp peduncle; and a snare cable is routed through the first forceps jaw and the second forceps jaw to form a loop (inverted ohm shaped) for grasping the polyp peduncle, the snare cable operatively connected to the catheter body, the first forceps jaw and the second forceps jaw configured to hold the polyp peduncle after pulling the snare cable and applying electrosurgical current, the first forceps jaw and the second forceps jaw configured to facilitate stabilizing the polyp pedicle and cut the polyp pedicle by the snare cable, the first forceps jaw and the second forceps jaw configured to collect resected polyp, the first forceps jaw and the second forceps jaw comprising forceps tips configured to hold a bleeding spot to control post polypectomy bleed and apply electro cauterization.
2. The polypectomy device of claim 1, wherein the first forceps jaw, the second forceps jaw and the snare cable are operatively connected to a source of electrosurgical energy electrosurgical unit.
3. The polypectomy device of claim 1, wherein the first forceps jaw and the second forceps jaw are triangle in shape with inner margins and lumens in body of jaws are different level configured to form a concave shaped in closed position which facilitates loop formation at different level and prevents inadvertent impaction loop in between jaw margins.
4. The polypectomy device of claim 1, wherein the snare cable is internally connected to a plurality of wires.
5. The polypectomy device of claim 1, wherein the forceps tips are configured to hold the polyp pedicle.
6. The polypectomy device of claim 1, wherein the forceps tips comprising an anti-slip jaw configured to facilitate grasping the polyp pedicle to provide mechanical tamponade.
7. The polypectomy device of claim 1, wherein the first forceps jaw and the second forceps jaw comprising a body configured to provide a structural strength necessary to allow the jaw forceps jaws to grasp the polyp pedicle with an appropriate pressure.
8. The polypectomy device of claim 1, further comprising at least one electrical connector configured to connect the catheter body to an electric power source.
9. The polypectomy device of claim 1, further comprising a plurality of cables is attached to the at least one electrical connector and to at least one handle.
10. The polypectomy device of claim 9, wherein the at least one handle is operated to open and close the first forceps jaw and the second forceps jaw.
11. The polypectomy device of claim 9, wherein the at least one handle configured to pull and push the snare cable and activate power source to narrow the loop and sever the polyp pedicle.
12. The polypectomy device of claim 9, wherein the at least one handle is configured to allow to and fro movement of a longitudinal cable leading to push up and extension of the first and second forceps jaws and pull down and retraction of the first and second forceps jaws.
13. The polypectomy device of claim 1, wherein the first forceps jaw and the second forceps jaw are operatively connected to the at least one handle by a longitudinal cable enclosed within a longitudinal flexible tubular cable sheath.
14. A method for cutting and sealing the polyp using a polypectomy device, comprising: inserting a polypectomy device into working channel of an endoscope by a user after a polyp peduncle is located on a part of the body; moving a distal end of a catheter body towards the polyp peduncle and opens a first forceps jaw and a second forceps jaw to capture either side of the polyp peduncle, whereby the first forceps jaw and the second forceps jaw are rotatable connected to a catheter body; forming at least one of: a semicircular closed loop; and a partially closed loop for encircling the polyp peduncle by a snare cable through first forceps jaw and the second forceps jaw, whereby the snare cable operatively connected to the catheter body; activating the snare cable and drawing snare cable proximally by pulling a handle to cut and seal the polyp peduncle and severing the polyp peduncle once the polyp peduncle is approximated by the first forceps jaw and the second forceps jaw, the first forceps jaw and the second forceps jaw configured to hold the polyp peduncle after pulling the snare cable and applying electrosurgical current; and cutting and sealing the polyp peduncle between the first forceps jaw and the second forceps jaw, the first forceps jaw and the second forceps jaw configured to facilitate stabilizing the polyp pedicle and cut the polyp pedicle by the snare cable.
15. The method of claim 14, further comprising a step of holding a bleeding spot by forceps tips to control post polypectomy bleed and applying electro cauterization.
PCT/IB2021/054036 2020-05-20 2021-05-12 Polypectomy device for excision of polyps and method employed thereof WO2021234508A1 (en)

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Cited By (1)

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RU2809203C1 (en) * 2023-02-27 2023-12-07 федеральное государственное бюджетное образовательное учреждение высшего образования "Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения Российской Федерации Method of endoscopic intraoperative truction of gastrointestinal tract forms using polypectomy loop

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US7044947B2 (en) * 2001-07-27 2006-05-16 Starion Instruments Corporation Polypectomy device and method
CN103006314A (en) * 2011-09-21 2013-04-03 邱梦琦 Jaw-type polypectomy device

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US7044947B2 (en) * 2001-07-27 2006-05-16 Starion Instruments Corporation Polypectomy device and method
CN103006314A (en) * 2011-09-21 2013-04-03 邱梦琦 Jaw-type polypectomy device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2809203C1 (en) * 2023-02-27 2023-12-07 федеральное государственное бюджетное образовательное учреждение высшего образования "Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения Российской Федерации Method of endoscopic intraoperative truction of gastrointestinal tract forms using polypectomy loop

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