FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
CALCULUS FRAGMENT ASPIRATION DEVICE BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY HAVING ADRESS AT
Survey No. 48, 3 & 48 7, Pashan - Sus Rd, Sus, Pune, Maharashtra 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE AND INVENTION THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of medical devices. More specifically, the present invention relates to endoscopic device with a suitable working device that allows easy and quick salvage of dust fragments from the kidneys.
BACKGROUND
[0002] Kidney stones (known as ureteral calculi in medical terminology) are a common medical problem that negatively impact millions of individuals worldwide. Kidney stones include one or more solid masses of material that are usually made of crystals and form in parts of the urinary tract including in the ureter, the kidney, and/or the bladder of the individual. Kidney stones range in size from smaller (less than about 1 cm) to very large (more than 4 cm) and may cause significant pain to the individual and damage to the kidney. The overwhelming majority of stones that are treated by surgeons are less than 1 cm.
[0003] The recommended treatment for removal of the kidney stones varies according to numerous factors including the size of the kidney stones, the number of kidney stones, and the location of the kidney stones. The most common treatments for kidney stones are shock wave lithotripsy, ureteroscopy, and percutaneous nephrolithotomy. The largest kidney stones are usually removed through percutaneous nephrolithotomy or nephrolithotripsy, or through other similar procedures.

[0004] Traditionally, smaller kidney stones have been treated using other, less invasive techniques including through ureteroscopy. In ureteroscopy, the surgeon typically inserts a ureteroscope into the urethra through the bladder and the ureter to provide the surgeon with a direct visualization of the kidney stone(s) which may reside in the ureter or kidney. The surgeon then removes the kidney stone directly using a basketing device if the kidney stone is small enough to pass through the urinary tract without difficulty, or the surgeon fractures the kidney stone into smaller pieces using a laser or other breaking device. After breaking the kidney stone into smaller pieces, the surgeon removes the laser or breaking device and inserts a basket or other object to capture the kidney stone fragments under the direct visualization of the ureteroscope. Upon retrieving some of the kidney stone fragments, the surgeon removes the basket from the patient and empties the kidney stone fragments therefrom. This process is repeated until clinically significant kidney stones and kidney stone fragments are broken up and removed from the body.
[0005] It should be apparent that this process is extremely time consuming, costly, and inefficient because the surgeon is required to insert and remove the scope and basket into and out of the patient many times to completely remove the kidney stones and kidney stone fragments therefrom. Using a basket removal device to capture kidney stones or kidney stone fragments suffers from other drawbacks in that the basket is difficult to position adjacent the kidney stone fragments and maneuver in a manner that effectively retrieves the fragments. Also, Treatment of kidney stones with ureteroscopic stone fragmentation or laser fibers produces stone fragments and stone powder or "sand". The calculus basket or stone basket may also have the problem of

removing calculus fragments that are less than 2 mm in size.The training required for such a procedure is not insignificant and the aforementioned basket removal technique is difficult for even the most skilled surgeons. Additionally, the surgeon is susceptible to hand fatigue due to the extended amount of time required to operate the kidney stone retrieval baskets. Further, the patient is required to be under local anesthesia and/or remain immobile over an extended amount of time. Still further, the basket retrieval devices cause irritation to the urinary tract due to the repeated insertion and removal therefrom.
[0006] It would be desirable to have a more robust clearance mechanism when small stones and stone powders are present in the renal pelvis of kidney which is more difficult to access. In these cases, unless small stones and stone powder are removed, they may continue to grow and aggregate until they become symptomatic and require more invasive treatment. Hence, there is a continuous demand for improvements and need for new devices and methods that permit minimally invasive removal of kidney stones.
[0007] This invention is therefore directed towards developing a system to facilitate complete removal of stone fragments or dust which cannot be captured by stone basket quickly and efficiently.

SUMMARY
[0008] 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.
[0009] An object of the present invention is to provide a stone fragments retrieval device to remove sand and dust fragments of crushed kidney stones without the need for a stone capturing basket adapted to removably attached to an ureteroscope.
[0010] Another object of the present invention is to provide an improved stone fragment retrieval device, more particularly to perform functions of suction and irrigation together with a mechanism for destroying or fragmenting objects within the body of a patient which can be easily used by the physician.
[0011] Yet another object of the invention is to provide a stone fragments retrieval device which selectively alter the suction or irrigation flow in the working channel for removing the sand and dust fragments of crushed kidney stones.
[0012] It is still another object of the present invention to provide a medical endoscope with a suitable working stone fragments retrieval device that allows easy and quick salvage of dust fragments from the operating area.

[0013] In an aspect of the present disclosure, a stone fragment aspiration device comprising a scope connector body removably attached to an endoscope is disclosed. The scope connector comprises of a single working channel having an inlet port and outlet port connected to an irrigation and suction pump via rubber tubes made up of elastomer material. The scope connector also comprises of a trigger lever attached to a pincher using screws and is able to rotate certain degrees against a torsion spring which helps it to return to fixed original position. The trigger lever selectively alter the suction or irrigation flow to the working channel. In normal condition i.e. the inlet port is normally open and outlet port is closed. During Irrigation function, saline liquid is infused inside the body lumens through scope as a means for clearing the stone fragments or debris as the lithotripsy progresses as well as to maintain a clear field of view through the endoscope during the procedure. During Suction function, the trigger lever is pressed by the operator which opens the outlet port by releasing the pinched outlet tube held by the upper knob of the pincher connected to the trigger lever. Suction function is performed to extract the stone dust along with the liquid inside the body lumens. Once the suction function is performed and all the dust fragments are extracted, the operator can release the trigger lever back to its original position.
[0014] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiment.
[0015] 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
[0016] 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.
[0017] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0018] Fig 1. illustrates an isometric view of the calculus fragments aspiration device in accordance with an exemplary embodiment of the present disclosure;
[0019] Fig. 2(a) and 2(b) illustrates the exploded view of the scope connector body of the calculus fragments aspiration device with an exemplary embodiment of the present disclosure;

[0020] Fig. 3(a)- 3(c) illustrates enlarged view of the scope connector body of the calculus fragments aspiration device in accordance with an exemplary embodiment of the present disclosure;
[0021] Fig. 4(a)- 4(d) illustrates a scope connector body of the calculus fragments aspiration device in accordance with an another embodiment of the present disclosure;
[0022] 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.
[0023] 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
[0024] 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. As used herein, a “plurality” refers to two or more, for example, three or more, four or more, five or more, six or more. Each possibility represents a separate embodiment of the invention.
[0025] For purposes of the present specification and claims, various relational terms like “top” “bottom,” “proximal,” “distal,” “upper,” “lower,” “front,” and “rear” are used to describe the present invention when said invention is positioned in or viewed from a given orientation. It is to be understood that, by altering the orientation of the invention, certain relational terms may need to be adjusted accordingly.
[0026] 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.
[0027] Referring now to the drawings, Figures. 1-4 illustrates a calculus fragments aspiration device having an improved alternate suction and irrigation mechanism to extract the dust fragments from the kidney in a more efficient and

quick manner 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.
[0028] Referring now to the drawings, Fig. 1 illustrates a calculus fragments aspiration device 100 comprising a scope connector body 102 configured to be coupled to an endoscope 104 with the help of a scope port connector 106 and a flange 108 which is to be seated on an ureteroscope.
[0029] Now referring to Fig. 2(a) and 2(b), the exploded view 200 of the scope connector body 102 is illustrated. The scope connector body 102 comprises of a long section 202 (hereafter referred as a “working channel”) having a proximal end 204 and a distal end 206. The distal end 206 is coupled to the endoscope 104 with the help of a scope port connector 106. In the laser lithotripsy procedure, the kidney stones are disrupted and broken up using laser which generate dust particles within the body cavity. A laser fibre is introduced through the proximal end 204 of the working channel 202 and the procedure of laser lithotripsy is performed.
[0030] An inlet port 208 and an outlet port 210 are provided near the proximal end 204 of the working channel 202 of the scope connector body 102 to provide saline to the urinary system and to extract the dust fragments respectively. Both ports i.e. inlet port 208 and outlet port 210 are connected to the working channel 202 through an inlet tube 212 and an outlet tube 214 via openings 216 in the scope connector body 102 which are further connected to the inlet and suction pumps (not shown). The tubes 212,214 are made up of elastomer materials like silicon

and like. The scope connector body 102 also comprises of a trigger lever 218 which is attached to the pincher 220 having an upper tab 222 and a lower tab 224 using screws 226. The trigger lever 218 is able to rotate certain degrees against a torsion spring 228 coupled to the scope body via a plug 230. The spring 228 helps the trigger lever 218 to return to fixed original position after rotating a certain degree.
[0031] Fig. 2(a) and 2(b) are mere examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The material of the tubes in the present invention is not limited to the elastomers but can be different according to the requirement of the thickness and flexibility of the tube.
[0032] Referring now to FIG. 3(a), the enlarged view of the of the calculus fragment aspiration device 100 in a normal condition i.e. the inlet port is normally open and outlet port is normally closed is disclosed. While performing an endoscopic procedure with a stone retrieval device within a body cavity or passageway, and especially while performing lithotripsy, a common problem is that stone fragments or debris from the lithotripsy clouds the endoscope's field of view. A means for clearing such debris is desirable both to remove the debris as the lithotripsy progresses, and to maintain a clear field of view through the endoscope during the procedure. During Irrigation function saline liquid is infused inside the body lumens through scope. The saline water is required for maintaining clear visibility inside the body and is also required for dusting operation as medium of power transfer for laser. The central shaft 302 of the pincher 220 rests on the bush surface on the scope connector body 102 as shown

in Fig 3(c). This provides a constrained axis of rotation to the pincher tabs 222,224 and trigger lever 218 subsequently. As shown in Fig 3(a), the outlet tube 214 is pinched using the upper pincher tab 222 attached to the trigger lever 218. The outlet tube 214 is pinched between the wedge of the pincher 220 and wall of the scope connector body 102. The torsion spring 228 keeps the trigger lever 218 in a position where the outlet tube 214 is always pinched.
[0033] The inlet and outlet tubes 212,214 respectively are arranged in such a way that only single rubber tube can be made operational at once. The trigger lever 218 is used to select between either of the functions of suction or irrigation. Suction function is performed to extract the stone dust fragments along with the liquid inside the body lumens.
[0034] Fig 3(b) illustrates the calculus fragment aspiration device when the outlet port is open and the inlet port is closed. The lower tab 224 pinches the inlet tube 212 while the operator presses the trigger lever 218 thereby releasing the outlet tube 214 from the pinched state, opening the outlet port 210 and extracting the stone dust fragments from the outlet tube 214 via outlet port 210.
[0035] Fig. 3(a) - 3(c) are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0036] Another embodiment in the present invention as shown in fig 4(a) - 4(d) includes the arrangement of an inlet and outlet tubes 410,412 respectively in the

scope connector body 402 parallelly. The scope connector body 402 comprises of a working channel 406 to introduce laser fibre for the surgery. An outlet tube tab 416 and an inlet tube tab 414 are arranged in an offset manner under the trigger lever 404 to selectively switch between the suction function and the irrigation function to extract out the dust fragments from the kidney.
[0037] Referring to fig 4(c) and 4(d), in normal condition i.e. during irrigation function, the outlet tube 412 is in pinched state by the outlet tube tab 416 attached to the trigger lever 404. The outlet tube 412 is pinched between the suction tab 416 of the trigger lever 404 and wall of the scope connector body 402. When the operator presses the trigger lever 402 during suction function, the inlet tube 410 gets pinched by the inlet tube tab 414 attached to the trigger lever 402.
[0038] Fig. 4(a) - 4(d) are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0039] It is observed that the dust fragments after lithotripsy procedure can be extracted out more quickly and efficiently.
[0040] It is further observed that along with the elimination of the stone capturing basket means, the calculus fragments aspiration device has provided the much needed advantage of extracting the dust fragments from the kidneys efficiently which avoids any further discomfort to the patient as it was the case in conventional methods of removing the stones from the kidneys. Along with

these advantages, there is a quick extraction of dust fragments, eventually saving the time of the patient as well as the physician described in the present invention.
[0041] The present invention has both technical as well as economic significance with respect to the conventional kidney stone retrieval devices.
[0042] 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 calculus fragments aspiration 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 calculus fragments aspiration device and/or elements described herein above while remaining within the scope of the invention.

We claim:
1. A surgical device for removing calculus fragments from a patient comprising:
a scope connector body 102 comprising a channel 202 having a proximal end 204
and a distal end 206 configured to be coupled to an ureteroscope 104 via a scope
connecting port 106;
wherein: the said channel 202 acts as a medium to introduce laser fibre or any other accessory for surgery, infusing saline liquid to kidneys as well as to aspire debris from the kidneys of a patient;
the said channel 202 further comprising an inlet port 208 and an outlet port 210 near the proximal end 204 of the said channel 202;
wherein: the said inlet port 208 and the outlet port 210 are connected to an inlet tube 212 and an outlet tube 214, both of which are further connected to an irrigation and negative pressure source respectively; and
an activator switch 218 connected to a pincher 220 on the said scope connector body 102;
wherein: the said pincher 220 comprises of an upper tab 222 and a lower tab 224 that allows switching between irrigation and suction modes by allowing flow of liquid when the user presses the activator switch 218.
2. The surgical device as claimed in claim 1, wherein the inlet port 208 is an
irrigation port to infuse saline liquid into the kidneys of a patient and is
connected to an irrigation supply source via inlet tube 212.

3. The surgical device as claimed in claim 1, wherein the outlet port 210 is a
suction port to aspire debris and urine from the kidneys of a patient and is
connected to a negative supply source via outlet tube 214.
4. The surgical device as claimed in claim 1, wherein the activator switch 218 is a trigger lever.
5. The surgical device of claim 1, wherein the irrigation and suction operations are not performed simultaneously.
6. The surgical device as claimed in claim 1, wherein when the activator switch 218 is in normal position the upper tab 222 of the pincher 220 keeps the flow from the outlet tube 214 blocked for the continuous flow of saline liquid through the inlet tube 212.
7. The surgical device as claimed in claim 1, wherein when the user presses the activator switch 218, the negative pressure gets applied and the lower tab 224 of the pincher 220 blocks the flow from the inlet tube 212 allowing the debris and urine to eventually get removed through the outlet tube 214.
8. The surgical device as claimed in claim 1, wherein the scope connecting port 106 is a leur lock.
9. The surgical device as claimed in claim 1, wherein the inlet 212 and outlet tube 214 are made up of elastomer material i.e. silicon.

10. The surgical device as claimed in claim 1, wherein the scope connector body 102 is made up of thermoplastic material i.e. ABS plastic.
11. A surgical device for removing calculus fragments from a patient comprising: A scope connector body 402 comprising a channel 406 configured to be coupled to an ureteroscope via a scope connecting port 408;
wherein:

the said channel 406 acts as a medium to introduce laser fibre or any other
accessory for surgery, infusing saline liquid to kidneys as well as to aspire debris
from the kidneys of a patient;
the said channel 406 is connected to an inlet tube 410 and an outlet tube 412 , both
of which are further connected to an irrigation and negative pressure source
respectively; and
an activator switch 404 on the said scope connector body 402;
wherein: the said activator switch 404 comprises of an inlet tube tab 414 and an outlet tube tab 416 that allows switching between irrigation and suction modes by allowing flow of liquid when the user presses the activator switch 404.
12. The surgical device as claimed in claim 11, wherein the inlet tube 410 allows infusion of saline liquid into the kidneys of a patient and is connected to an irrigation supply source
13. The surgical device as claimed in claim 11, wherein the outlet tube 412 allows suction of debris and urine from the kidneys of a patient and is connected to a negative supply source.
14. The surgical device as claimed in claim 11, wherein the activator switch 404 is a trigger lever.
15. The surgical device of claim 11, wherein the irrigation and suction operations are not performed simultaneously.
16. The surgical device as claimed in claim 11, wherein when the activator switch 404 is in normal position the outlet tab 416 keeps the flow from the outlet tube 412 blocked for the continuous flow of saline liquid through the inlet tube 410.
17. The surgical device as claimed in claim 11, wherein when the user presses the activator switch 404, negative pressure is applied and the inlet tab 414 blocks the

flow from the inlet tube 410 allowing the debris and urine to eventually get removed through the outlet tube 412.
18. The surgical device as claimed in claim 11, wherein the scope connecting port 408 is a leur lock.
19. The surgical device as claimed in claim 11, wherein the inlet 410 and outlet tube 412 are made up of elastomer material i.e. silicon.
20. The surgical device as claimed in claim 11, wherein the scope connector body 402 is made up of thermoplastic material i.e. ABS plastic.