FORM 2
THE PATENTS ACT, 1970 (39 OF1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[SEE SECTION 10, RULE 13]
A MULTIBAND LIGATOR CONTROLLER
DEVICE
APPLICANT:
BIORAD MEDISYS PRIVATE LIMITED
AN INDIANCOMPANYHAVING OFFICE ADDRESS AT
Survey No. 48, 3 & 48 7, Pashan - Sus Rd, Sus, Pune, Maharashtra 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED

FIELD OF THE INVENTION
The present invention relates generally to the field of endoscopic ligation. More particularly, the invention relates to a device adapted for use in conjunction with an endoscope for the treatment of ligating lesions.
BACKGROUND
[0001] Esophageal varices are enlarged esophageal veins. When weak portions of blood vessels protrude from parts of patients' bodies, such as the walls of the esophagus, or when portions of the walls of the esophagus bleed, the patients may be in danger because of bleeding from the above-mentioned lesions. Ligation of the varices can be performed to treat acutely bleeding varices and also may be used to treat varices, polyps, hemorrhoids, or other lesions. The conventional therapies like electric cauterization, laser cauterization, or heat irradiation therapy, etc., or by drug therapies using injections may injure or affect healthy tissues of the patients around the lesions
[0002] To avoid the above-mentioned problems of conventional therapies, recently, band ligators have been used. Band ligators are devices that are used to deliver an elastic band in an expanded configuration to a tissue location then release it around the treatment site permitting it to return to its relaxed orientation to constrict the tissue. Band ligators have been adapted to be attached to the distal end of endoscopes to facilitate application of bands to treatment sites in natural body lumens such as the esophagus or rectum.

Endoscopic band ligators have become especially useful in treating esophageal varices. A band ligator attached to the distal end of a flexible viewing endoscope can be navigated, visually, directly to a varix location to accurately apply a ligating band.
[0003] Various methods have been proposed and used to sequentially supply the ligating bands to the lesions. However, accurate operation of a multiple band endoscopic ligating device centers on the physician's ability to remotely control the device from outside the patient. Control handles for operating ligating devices has been somewhat primitive and may require two hands to operate. Two handed operation of the ligator control handle is especially problematic in endoscopic context because at least one hand must be used to operate endoscope controls for articulating the distal end of the endoscope so that it may be properly navigated. As a result, operation of known endoscopic band ligators typically requires two people to operate all the necessary controls at the proximal end of the endoscope.
[0004] In many instances, however, there are a number of lesions present in the organ being treated, such as the esophagus, stomach or colon. If an endoscopic instrument equipped with only one elastic ring is used, the treatment of multiple lesions in the same organ requires withdrawal of the endoscope after the placing of each elastic ring about a lesion, reloading the endoscope with a ring, and reinsertion of the endoscope back into the organ to repeat the procedure for placing an elastic ligating ring about each additional lesions. In addition to being time consuming and an associated concern for blood loss when there are bleeding lesions, there are other disadvantages associated with

the repetitions of this procedure. The instrument, when withdrawn from the body, is usually covered with blood and mucous. Furthermore, each time the instrument is reinserted into the organ, it becomes necessary to relocate a lesion to be treated and to orient the instrument with respect thereto. In some cases where considerable blood and mucous are present, the relocating of the instrument is a tedious and difficult task. Sometimes, problems arise that more than one band could be inadvertently released at a single site or the device could fail to release any bands at the location. Further frustrating this problem is the fact that the physician may not realize that a single band is not successfully released at the desired location.
[0005] Accordingly, there is a need for simplified band ligator device for a medical treatment so that the ligating bands are sequentially and efficiently supplied to lesions of a patient body. This invention is therefore directed towards providing an improved method and device, which is relatively simple in design and structure, and is highly effective for its intended purpose.
SUMMARY
[0006] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.

[0007] An object of the present invention is to provide an
endoscopic band ligator control handle that is easy to manipulate with a single hand in conjunction with maintaining control over the endoscope shaft.
[0008] Another object of the present invention is to provide a method of endoscopically applying multiple ligation bands that requires simplified inputs by the user on a control handle that operates the distally mounted ligator.
[0009] Yet another object of the invention is to improve the reliability with which bands can be released from the ligating device at a treatment site.
[0010] Still another object of the invention is to provide a device which is convenient to use and which can be readily disconnected from the endoscope after the completion of the procedure.
[0011] It is an object of the present invention to provide an improved ligating instrument where the surgeon can very quickly and with great safety perform the operation by himself using band ligator controller, which further can lead to reduction of staff in connection with the surgery.
[0012] The present invention provides multiband ligator controller deviceto apply ligating bands to tissue areas of a patient efficiently using the band ligator. The controller device of the present invention discloses a single-hand operated controller device that is slidably and removably mounted within

working channel of endoscope. The multiband ligating contoller device is operated by a controller knob positioned on the handle hub of the device and is connected to the handle shaft with variable diameter which extends through the first and second openings present on the first and second arm of the handle hub. The handle shaft is provided with variable diameter to accommodate the trigger cord roller and to get sufficiently engage within the unidirectional bearing. The trigger cord on the trigger cord roller is wind around the channel present in the trigger cord roller due to the actuation of the extension-retraction function of the handle shaft as the controller knob is rotated. After the handle shaft is activated in lock position, the surgeon rotates the controller knob which enables the band delivery function of the ligator located at the distal tip of the endoscope with accuracy. The surgeon will get a tactile and two audible feedbacks after each deployment of band due to the stopper located at the proximal end of the handle shaft. The feature will avoid multiple firing of bands in a single handle rotation. Further, When saline water passes through the irrigation port given in the stem of the handle hub , the saline will not leak through the seal positioned at the bottom of the handle hub which results in any discomfort to the user because of the leak proof seal design.
[0013] These and other features and advantages of the present invention will become apparent from the following description of the invention that is provided in connection with the accompanying drawings and illustrated embodiments of the invention.
[0014] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing

from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0015] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example 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.
[0016] The foregoing and other objects and advantages of the invention will be appreciated more fully from the following further description thereof, with reference to the accompanying diagrammatic drawings wherein:
[0017] Fig 1. Illustrates a perspective view of the multiband ligator controller device in accordance with an exemplary embodiment of the present disclosure;
[0018] Fig. 2 illustrates an exploded view of the multiband ligator controller
device in accordance with an exemplary embodiment of the present
disclosure;

[0019] Fig. 3(a) - 3(g) illustrates various views of the components of the multiband ligator controller device with an exemplary embodiment of the present disclosure;
[0020] Fig.4 (a)-4(d) illustrates views of assembling the multiband ligator controller device to the working channel of the endoscope and also winding of trigger cord to the trigger cord roller with an exemplary embodiment of the present disclosure.
[0021] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.
[0022] Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.
DETAILED DESCRIPTION OF EMBODIMENTS

[0023] The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. The words "comprising," "having," "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.
[0024] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.
[0025] Referring now to the drawings, Figures. 1-4 illustrate a multiband ligator controller device 100 according to present invention. It should be noted that Figure 1-4 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure.
[0026] Fig. 1 illustrates a multiband ligator controller device 100 comprising a handle hub 102 with a hub base 104, a handle shaft pin 106, a trigger cord roller

108, a controller knob 110, a stem 112 connected to the hub base 104 and an irrigation tube 114 connected to the scope stem 112.
[0027] Now referring to Fig. 2, the exploded view 200 of the multiband ligator controller device is illustrated. As can be seen, the controller knob 110 is connected to a handle shaft 202 to permit manual rotation of the handle shaft 202. A seal 204 is provided between the scope stem 112 and the hub base 104 of the handle hub 102.
[0028] Fig. 3(a) - 3(g) illustrates the various components of the multiband ligator controller device 100. As shown in Fig. 3(a) and 3 (b) , the handle hub 102 comprises of a first arm 302 extending upwardly from the base 104 of the handle hub 102 having a first cavity 304 to accommodate a spring 306 and a first opening 308 through which the handle shaft 202 extends. The handle hub 102 further includes a second arm 310 extending upwardly from the base 104 of the handle hub 102 having a second cavity 312 and a second opening 314 within which a unidirectional bearing 316 can be disposed. The handle hub 102 is configured to be releasably and slidably mounted onto an endoscope working channel with the help of the stem 112 (as shown in Fig 4(a) later in the description).
[0029] Fig 3(c) illustrates the trigger cord roller 108. As can be seen, the trigger cord roller 108 comprises of a channel 318 on the outer circumference of the trigger cord 108 with a plurality of grooves 320. The channel is sized and configured to receive a trigger cord 408 (Ref. Fig 4(d)) therein but is too small to permit the knot to pass therethrough. The grooves are sized and configured

to receive the locking knot therein so that the end of the trigger cord 408 can be securely connected with trigger cord roller 108. The rotation of the trigger cord roller 108 allows the trigger cord 408 to be wind around the outside of the trigger cord roller 108 when the trigger cord 408 is drawn through endoscope working channel port 402(Ref. Fig 4(a)).
[0030] Now referring to the Fig. 3(d), the handle shaft 202 comprises of a proximal end 324 and a distal end 326. The proximal end 324 of the handle shaft 202 is sized and configured to securely fit into a retention groove 322 of the controller knob 110. The proximal end 324 of the handle shaft 202 also includes a stopper 328 (Ref. Fig. 3(e)) having a plurality of ribs 330. The surgeon will get a tactile and audible feedback after each deployment of band due to the stopper 328. This will help in avoiding multiple firing of bands in a single controller knob rotation.
[0031] The shaft handle 202 also includes a trigger cord roller mounting section 332 that is adapted to hold the trigger cord roller 108. The trigger cord roller mounting section 332 has a configuration similar to the configuration of the inner diameter of the trigger cord roller 108. In the present embodiment trigger cord roller mounting section 332 has a square cross-section to match the square cross-section of the bore of the trigger cord roller 108. It is understood that other configurations of the inner diameter of trigger cord roller and trigger cord roller mounting section can be designed by the person skilled in the art. For example, circular and other geometrical shapes and the like.

[0032] The distal end 326 of the handle shaft 202 has a narrower end having diameter that is slightly smaller than the inner diameter of the unidirectional bearing 316 so that it does not engage the bearing, but simply rotates within the bearing with the rotation of the handle shaft 202. The unidirectional bearing 316 prevents the trigger cord roller 108 from reversely rotating preventing an operational error during surgery.
[0033] Fig 3(f) and 3(g) illustrates the seal 204 that is provided between the stem 112 and the hub base 104 of the handle hub 102. As can be seen in Fig 3(g), the seal 204 comprises of a plurality of diaphragm 334 adapted to maintain a sealed environment within the working channel wherein when the saline water passes through the irrigation port given in the handle,the saline will not leak through the seal 204 and does not cause any discomfort to the user because of the leak proof design of the seal. The seal 204 is preferably composed of a resilient and flexible material preferably silicone.
[0034] Fig. 3(a)- 3(g) are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0035] The embodiment of the present invention is used for endoscopic ligation of esophageal varices at or above the gastro esophageal junction. However, it is not necessary limited to this particular application and can be used for treatment of different applications. As shown in Fig.4 (a), the stem 112 located at the base 104 of the handle hub 102 is mounted onto a proximal end of an endoscope working channel port 402. The handle shaft 202 is designed in such

a way that it can reciprocate within the first opening 308 on the first arm 302 and the second opening 314 on the second arm 310 of the handle hub 102. The handle hub 102 has two positions which control rotation. If the controller knob 110 is pushed in the direction of arrow on the second arm 310 of the handle hub 102, it indicates LOCK position that allows handle shaft 202 to be rotated in forward direction only. If the controller knob 110 is pushed in the direction of arrow on the first arm 302 of the handle hub 102, it indicates OPEN position that allows handle shaft 202 to rotate in both directions. It is to be noted that prior to introducing endoscope, the shaft handle in kept in "OPEN" position.
[0036] The hook tube 404 is introduced through the seal 204 from the top of the base 104 of the handle hub 102 and is advanced in short increments until it exits tip of endoscope at the distal end of the endoscope as shown in Fig.4(b) and 4(c) wherein the trigger cord 408 is attached to the hook end 406 of the hook tube 404 and is retracted manually through the seal 204 via working channel of the endoscope. This trigger cord 408 can then be oriented within the channel 318 in the thread roller 108 and is pulled down until a knot (that is formed by passing a barrel thread (not shown) of a band barrel (not shown) through the loop of the trigger cord) is seated in the groove 322.
[0037] The bands are connected to a barrel cord (not shown) having multiple bead pushers behind each of the bands and is knotted with the trigger cord 408. To deploy the ligation bands after locating a varix with the help of the endoscope, the controller knob 110 is pushed to keep the handle shaft in lock position. As the controller knob 110 is rotated,the trigger cord 408 is wind around the trigger cord roller 108 as shown in Fig.4(d) thereby pulling the

distal end pusher beads which results in releasing one of the bands. While continuing doing so there will be two audible feedbacks. The first sound (click) indicates that the band has been fired from the ligating end to surround the base of the varix as desired and the second click will provide the user that he need to control his speed of handle rotation to avoid unnecessary firing of band. The stopper ribs 330 acts as a stopper and controls the angular moment of inertia of controller knob. This is repeated until all desired varices are ligated or all ligating bands have been ejected from the ligator.
[0038] It is observed that during surgery it is easy and convenient to apply multiple ligation bands that requires simplified inputs by the user on a control handle. Along with these advantages, there is improvement in the reliability with which bands can be released from the ligating device at a treatment site. The present invention also eliminates the time consuming surgery as well as an extra staff in connection with the surgery as described in the present invention.
[0039] The present invention has both technical as well as economic significance with respect to the conventional devices for ligation or the like.
[0040] While a particular embodiment of the invention has been illustrated and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiment, details and constructions of the multiband ligator controller device and their features described above and illustrated in the attached Figures may be interchanged among the various embodiment while remaining within the scope of the invention. Additionally,

it is understood that various modifications could be made to any of the controller device and/or elements described herein above while remaining within the scope of the invention.

We Claim:
1. A single hand operated multiband ligator controller device 100 for applying ligating bands to tissue areas of a patient, comprising:
a handle hub102 having a first arm 302 and a second arm 310, each arm having an opening;
a handle shaft 202 with a variable diameter extending through first opening 308 and a second openings 314 present on the first arm 302 and second arm 310 of the handle hub 102;
a controller knob 110 positioned on the handle hub 102 and connected to the handle shaft 202, the said controller knob 110 being rotatable to activate an extension-retraction function and a band delivery function at a distal tip of the endoscope when the handle shaft 202 is activated in a lock position;
a trigger cord roller 108 mounted on the handle shaft 202 and having a channel 318 with a pair of grooves 320 for winding a trigger cord 408;
a unidirectional bearing 316 disposed between the handle shaft 202 and the trigger cord roller 108;
a tactile and audible feedback provided to a surgeon after each deployment of a band, facilitated by a stopper 328 located at a proximal end of the handle

shaft 202, wherein the said stopper 328 comprises a plurality of ribs 330 to prevent multiple band firings in a single handle rotation; and
a seal 204 comprising a plurality of diaphragms 324 positioned at a bottom of the handle hub 102 and configured to prevent leakage of saline water passing through an irrigation port provided in a stem 112 of the handle hub 102.
2. The device of claim 1, wherein the handle shaft 202 is provided with a variable diameter to accommodate the trigger cord roller 108 and to engage securely within the unidirectional bearing 316.
3. The device of claim 1, wherein the unidirectional bearing 316 permits movement of the handle shaft 202 in a single direction corresponding to the extension-retraction function.
4. The device of claim 1, wherein the tactile and audible feedbacks generated by
the stopper 328 to indicate the deployment of a ligating band and to prevent
unintended multiple band firings are 2.