FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
INTEGRATED SCOPE CONNECTOR BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY REGISTERED UNDER THE COMPANIES ACT WITH ADDRESS: SURVEY NO. 48, 3 & 48 7, PASHAN – SUS ROAD, 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
[0001] The present invention relates generally to the field of medical devices. More specifically, the present invention relates to a surgical suction device that removes stone fragments or stone dust/debris/sand from the kidneys of a patient through a channel that is in communication with a suction source device.
BACKGROUND
[0002] Kidney stones 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, Retrograde Intrarenal Surgery (RIRS) and Percutaneous Nephrolithotomy. The largest kidney stones are usually removed through Percutaneous Nephrolithotomy or Nephrolithotripsy, or through other similar procedures. Recently, lasers have been used as an alternative source of energy in lithotripsy, especially for the destruction of renal and biliary stones. Laser Lithotripsy procedures are getting popularity in today’s Urology world primarily because of their ability to break the stones into tiny fragments and dusts sizing less than 0.2mm. Various types of laser lithotripsy systems with a variety of laser sources, including pulsed dye laser, alexandrite laser, neodymium laser and holmium laser, have been developed. [0004] Care path for Laser Lithotripsy starts with the admission of the patient into the hospital after confirmation of Stone size, location & suitability for Lithotripsy through Laser. Patient undergoes Laser Lithotripsy procedure with or without pre-dilatation using an access sheath, a suitable size of endoscope (a ureteroscope of 9 Fr or 7.5 Fr) and a suitable Laser Delivery system. Traditionally, 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
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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] Stenting is usually followed after a Laser Lithotripsy procedure under local or general anaesthesia. Patient is kept under observation and bed rest with a Foley’s catheter in place to let the patient pass urine in a urine bag. After 24 hours of observation, when the urine is clear, the patient gets discharged from the hospital and is asked to keep the Stents for a week. During this time, patient is asked to collect the stone fragments through gauge or stone collector mesh. However it is impossible to catch the stones of such small size. After one week, patient needs to get admitted again to get the ureteral stent removed. Most of the time it is done under local or general anaesthesia. Patient is discharged same day.
[0006] However there are several disadvantages of this entire cycle .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. It is not possible to confirm if all stone fragments gets drained out of Kidney. The treatment of kidney stones with ureteroscopic stone fragmentation or laser fibres produces stone fragments, 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. Most of the time the stent causes discomfort to the patient especially during movement. Patient re-admission is required for stent removal and that too under anaesthesia. Moreover it is very difficult to catch enough stone fragments for getting a stone analysis done. It is very painful to remove Foley’s Catheter as it is not done under anaesthesia
[0007] There is a continuous and unmet demand for improvements to the above problems that exists in today’s traditional method of Laser lithotripsy. This invention is therefore directed
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towards developing a new system or device to facilitate complete removal of stone fragments/dust with minimally invasive surgery.
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 kidney stone dust suction device to
aspire the stone dust fragments/sand completely from the kidneys.
[0010] Another object of the present invention is to eliminate use of stone capturing baskets for
extremely tiny kidney stones.
[0011] Another object of the present invention is to eliminate need for stenting and use of Foley
catheter.
[0012] Yet another object of the invention is to provide a means for sample collection to collect
the stone dust/debris so that the collected stone dust can be made available for histopathology,
which can aid in patient specific diagnosis, treatment & diet management to avoid recurrence
study.
[0013] Still a further object of the invention is to reduce surgery time which further reduces
patient recovery time.
[0014] Further objects and advantages of preferred embodiments of the device described herein
are that such preferred embodiments avoid need for post-surgical USG or CT scans for
confirmation thereby reducing the post-surgical treatment/diagnosis costs which ultimately gives
cost benefit to patient.
[0015] In an aspect of the present disclosure, an integrated scope connector device which can be
removably attached to an ureteroscope is disclosed. The integrated scope connector comprises of
a body having an irrigation port and a suction port connected to an irrigation and suction source.
The scope connector also comprises of a rotable switching adapter to selectively alter the suction
or irrigation flow to the working channel of the ureteroscope. During operation, laser fiber is
allowed in a scaled manner through the laser fiber port to perform laser lithotripsy. The saline
liquid is infused through irrigation port and inside the kidneys through scope via the plurality of
apertures in the rotable switching adapter and a common channel for irrigation and suction. The
suction port is opened by rotating the rotable switching adapter. The stone dust fragments are 4

aspired out with the urine through common channel for irrigation and suction via apertures in the rotable switching adapter and eventually through the suction port. The surgeon controls the suction by covering a bleeding port on the body of integrated scope connector by his finger to have a better suction efficiency of the dust fragments.
[0016] 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. [0017] 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
[0018] 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.
[0019] Embodiment of the present disclosure will now be described, by way of example only,
with reference to the following diagrams wherein:
[0020] Fig 1. illustrates an perspective view of the integrated scope connector device in
accordance with an exemplary embodiment of the present disclosure
[0021] Fig 2. illustrates a sectional view of the integrated scope connector device in accordance
with an exemplary embodiment of the present disclosure;
[0022] Fig. 3(a) and 3(b) illustrates the perspective view of a switching adaptor of the integrated
scope connector device with an exemplary embodiment of the present disclosure;
[0023] Fig. 4 illustrates a sectional view of the integrated scope connector device in irrigation
mode function in accordance with an exemplary embodiment of the present disclosure;
[0024] Fig. 5 illustrates sectional view of the integrated scope connector device in irrigation
mode function in accordance with an exemplary embodiment of the present disclosure;
[0025] 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. 5

[0026] 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
[0027] 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.
[0028] 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.
[0029] 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.
[0030] Referring now to the drawings, Figures. 1-4 illustrate a surgical integrated scope
connector device having an improved alternate suction and irrigation mechanism to completely
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. 6

[0031] Referring now to the drawings, Fig. 1 illustrates an integrated scope connector 100 having a hand held graspable handle body 102 with a proximal end 104 and a distal end 106, a scope connecting port 108 and a laser fiber port 110 at the distal end 106. The integrated scope connector 100 further comprises of a switching adaptor 112, a first port i.e. an irrigation port 114 and a second port i.e. a suction port 116 at the distal end 106. Furthermore, the integrated scope connector 100 comprises of a bleeder port 118 and a flange 120 which is to be seated on a flexible endoscope (not shown). The endoscope can be uretheroscope, cystoscope and the like. In the particular embodiment of the invention, the integrated scope connector device 100 may be used in combination with an ureteroscope. The scope connecting port 108 can be a leur lock or any other means of seal proof locking with the working channel of the ureteroscope. The integrated scope connector is made up of thermoplastic material such as Acrylonitrile butadiene styrene. However, other materials can also be used in manufacturing of the body of the device. [0032] Fig. 1 is a mere example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure
[0033] Fig. 2 illustrates the cross section view 200 of the integrated scope connector device 100. The integrated scope connector device 100 is adapted to be connected to a working channel of flexible ureteroscope (not shown) through a scope connecting port 108. The integrated scope connector 100 has a first channel 202 that is adapted to connect a laser fiber port 110 to the working channel of flexible ureteroscope (not shown) via a scope connecting port 108. The first channel 202 is connected to a second channel 204 that is a common suction and irrigation channel to provide saline to the kidneys and to aspirate the dust sand/debris after being crushed by laser lithotripsy. The size and shape of the second channel 204 may be configured to about 1¬2mm for aspiration of debris.
[0034] The second channel 204 is connected to the switching adaptor 112 which is used to switch between suction and irrigation system during operation. The switching adaptor can be a knob (herein referred as a rotary knob). The integrated scope connector handle body 102 has an irrigation port 114 at the proximal end 104 that is adapted to be connected to an irrigation source (not shown) to supply irrigation fluid to the kidneys. The irrigation source can be a pump or any other suitable means known in the art. The irrigation fluid is continuously provided through the irrigation port providing a sufficient level of irrigation (relative to the level of suctioning) which
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inhibits, reduces, and/or prevents suctioning of kidney tissue may improve the safety and/or efficacy of the removal device.
[0035] The suction port 116 on the proximal end 104 of the handle body 102 of the integrated scope connector 100 comprises of two openings wherein a first opening 206 is coupled to a source of negative pressure (not shown). The negative pressure source can be a wall suction outlet, a negative pressure pump, or any other suitable means known in the art. The suction port 116 further comprises of a second opening 208 that is configured to connect to a bleeder port 118 via a bleeder channel 210 that is provided on the handle body 102 of the integrated scope connector 100 and is coverable by a human finger.
[0036] Fig. 2 is merely an example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. A means for sample collection basically a filter and a collection container (not shown) can be provided in between the suction port 116 and the negative pressure source to collect the stone dust/debris so that the collected stone dust can be made available for histopathology, which can aid in patient specific diagnosis, treatment & diet management to avoid recurrence study.
[0037] Now referring to Fig. 3(a) and 3(b), the perspective view 300 of the rotary knob of the integrated scope connector device 100 is illustrated. The rotary knob 112 comprises of a plurality of apertures 302 adapted to allow the flow of the fluid through them towards the irrigation and suction ports depending on the need of the irrigation or suction functions by rotating the rotary knob. In the present embodiment, the plurality of apertures 302 in the knob are positioned in such a way that suction may be provided during any period in which irrigation is not provided and irrigation may be provided during any period in which suction is not provided. This is implemented by providing irrigation port open as a default, except during a period when suction port is positively activated by a user and in that case irrigation port is temporarily closed. The rotary knob 112 is of cylindrical shape and is made up of thermoplastic material such as Acrylonitrile butadiene styrene. The bottom of the rotary knob 112 may be solid or hollow. [0038] Fig. 3 is merely an example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. In some embodiments, the design of the knob may be modified to provide both suction and irrigation continuously. In some embodiments, suction may be provided continuously and irrigation may
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be provided intermittently. In some embodiments, both suction and irrigation may be provided
intermittently.
[0039] Fig. 4 illustrates the sectional view of the device in an irrigation mode operation. In the
present invention, during operation, the integrated scope connector 100 is connected to the
working channel of the flexible or partially flexible ureteroscope with the help of scope
connecting port 108. Laser fiber is allowed in a scaled manner through the laser fiber port 110
and the laser lithotripsy procedure is performed on the patient. During Irrigation function, saline
liquid is infused through irrigation port 114 and inside the kidneys through scope via the
plurality of apertures 302 of the rotary knob 112 and second channel 204 (shown by the arrows).
The saline liquid is required for maintaining clear field of view through the ureteroscope inside
the body and is also required for dusting operation as medium of power transfer for laser as
the lithotripsy progresses. The saline is continuously fed to the kidneys while performing laser
lithotripsy. To prevent the entry of the saline liquid out of the laser fiber port 110, a sealing
element basically a borst adapter (not shown) is connected at the entry of the laser fiber port 110.
[0040] Fig. 5 illustrates the sectional view of the device in a suction mode operation. The suction
port 116 is opened by rotating the knob 112. The stone dust fragments are aspired out with the
urine through second channel 204 via apertures 302 in the rotary knob 112 and eventually
through the first opening 206 of the suction port 116 when the rotary knob 112 is rotated. The air
is sucked from the second opening of the suction port 116 208 through the bleeder channel 210,
if the bleeding port 118 on the handle body 102 is not covered by surgeons’ finger. Sometimes
the dust fragments gets stuck into the second channel 204 due to the bigger size of the dust
fragments. Hence, the surgeon controls the suction by removing his finger time to time from the
bleeding port 118 to have a better suction efficiency of the dust fragments. By removing the
finger from the bleeding port 118 the air is allowed to pass from the bleeding port as well and
hence this creates a back pressure into the second channel 204 which allows the dust fragments
to move in the second channel 204 if they get stuck. The urine and debris passes to the collection
canister via a sample collector wherein the coarse stone dust fragments/debris gets trapped in the
sample collector media and fine dust fragments/debris and urine gets collected in the collection
canister wherein the collected sample may be given for further pathological study.
[0041] Fig. 4 and 5 are mere examples. A person skilled in the art will recognize many
variations, alternatives, and modifications of the embodiment of the present disclosure. 9

[0042] It is further observed that along with the elimination of the stone capturing basket means, the integrated scope connector 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 elimination of stenting process as well as Foley’s catheter described in the present invention.
[0043] The present invention has both technical as well as economic significance with respect to the conventional methods of laser lithotripsy and dust extraction devices from the kidneys. [0044] 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 integrated scope connector, and its 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 integrated scope connector device and/or elements described herein above while remaining within the scope of the invention.

CLAIMS
We claim:
1. A surgical irrigation and suction control device comprising:
a manually graspable handle body 102 having a proximal end 104 and a distal end 106;
wherein:
the said distal end 106 comprises :
a first channel 202 configured to connect a laser port 110 and a working channel of an ureteroscope via a scope connecting port 108 adapted to be connected to an ureteroscope;
a second channel 204 configured to be connected to the said first channel 202 wherein, the said second channel 204 acts as a medium of infusing saline liquid to the kidneys as well as to aspire the debris through a first port 114 and a second port 116 respectively on the said proximal end 104 of the handle body 102;
the said second port 116 comprises a first opening 206 and a second opening 208 wherein the first opening 206 is connected to a negative pressure source and the said second opening 208 is connected to a bleeder port 118 on the said handle body 102 via a bleeder channel 210;
wherein:
the bleeder port 118 is positioned to be finger actuated by a
surgeon holding handle body 102 wherein, the surgeon covers and
uncovers the said bleeder port 118 by his fingers for better suction
efficiency of the debris; and
a switchable adapter 112 on the said handle body 102 wherein the switchable adapter
112 is configured to switch between irrigation and suction modes by allowing the flow of fluid
through a plurality of apertures 302 in the said switchable adapter 112.
2. The surgical irrigation and suction control device as claimed in claim 1, wherein the first port is an irrigation port to infuse saline liquid into the kidneys of a patient and is connected to an irrigation supply source.
3. The surgical irrigation and suction control device as claimed in claim 1, wherein the second
port is a suction port to aspire debris and urine from the kidneys of a patient and is connected to a
negative supply source. 11

4. The surgical irrigation and suction control device as claimed in claim 1, wherein the second
channel is a common channel for irrigation and suction fluid.
5. The surgical irrigation and suction control device as claimed in claim 1, wherein the switchable adapter is a rotary knob.
6. The surgical irrigation and suction control device of claim 1, wherein the irrigation and suction operations are not actuated simultaneously.
7. The surgical irrigation and suction control device as claimed in claim 1, wherein the scope
connecting port is a leur lock.