FORM 2
THE PATENTS ACT,1970 (39OF1970) & THE PATENTS RULES,2003
COMPLETE SPECIFICATION
[SEE SECTION 10,RULE 13]
A SINGLE HAND OPERATED TWOPIECE URETEROSCOPE DEVICE
APPLICANT:
BIORAD MEDISYS PRIVATE LIMITED
ANINDIANCOMPANYHAVING OFFICE ADDRESS AT
Survey No. 48, 3 & 48 7, Pashan - Sus Rd, Sus, Pune, Maharashtra 411021

FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of medical
devices. More specifically, the present invention relates to an endoscopic device particularly a ureteroscope havingdisposable and reusable components and method of assembling them.
BACKGROUND
[0002] Endoscopic devices for surgical or diagnostic procedure are
already known. The endoscopy is a procedure in which a physician uses a
specialized instrument, generally a tubular member into the body cavity to
observe and operate on the internal organs or interior surfaces inside a
patient's body without making large incisions. A conventional endoscope is
generally an instrument with a distal end comprising an optical or electronic
imaging system, a proximal end with controls for manipulating the tool and
devices for viewing the image, and a solid or tubular elongate shaft
connecting the ends. A wide range of applications have been developed for
the general field of endoscopes including, but not necessarily limited to:
laparoscopy, arthroscopy, cystoscopy, ureteroscopy, hysterectomy
colonoscopy, upper endoscopy, bronchoscopy, thoracoscopy, and
hysteroscopy, (hereinafter referred to generally as “endoscope”).
[0003] To use an endoscope, a physician inserts the distal end into a
patient through a natural orifice or an artificial incision and then pushes the shaft into the patient until the distal end reaches a site of interest. The

proximal end remains outside the patient and typically connects to an eyepiece, video monitor, or other equipment. Some endoscopes let the physician pass tools or treatments down a hollow channel, for example, to resect tissue or retrieve objects. Other endoscopes are strictly inspection devices and not used for remote procedures. Disposable endoscopy is an emerging category of endoscopic instruments. In some cases the manufacture of single use endoscopes can be expensive enough to be used on a single patient only, because after a single use the whole device is thrown eventually increasing material wastage. Though, disposable or single-use endoscopy lessens the risk of cross-contamination and hospital acquired diseases, but sometimes these single use endoscopes are not disposed and used multiple times on different patients. In order to use the same endoscope multiple times, after an endoscope is used on a particular patient, the endoscope must be sterilized before it can be used again. The goal of sterilization is to remove all foreign matter and all pathogens. However, it is difficult to clean and disinfect thoroughly every time which leads to potential problems of cross-contamination between patients and between patients and staff.
[0004] To overcome the above problems, there is a need for split type
disposable endoscopes wherein the part of the endoscope which is in direct contact with the patient fluids is disposed of and the part which is not in contact can be reused again and again. This invention is therefore directed towards providing an improved split type endoscope, which is relatively simple in design and structure, and is highly effective for its intended purpose.

SUMMARY
[0005] 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.
[0006] An object of the present invention is to provide an improved
ureteroscope with a combination of disposable and reusable components which can be easily used by the physician.
[0007] Another object of the present invention is to provide an
improved ureteroscope having a disposable part adapted to detachably engage a reusable part, such that an interface or operative connection is established between the internal components of both reusable and disposable part when engaged together.
[0008] Yet another object of the invention is to provide a ureteroscope
device which is simple in structure, easy to assemble and disassemble, easy and convenient to operate, saves operation time and high in working efficiency.
[0009] It is still another object of the present invention to provide an
improved ureteroscope which reduce costs and material wastage by including some reusable and some disposable components.
[0010] Disclosed herein a single-hand operated two-piece ureteroscope
device comprising a reusable part and a disposable part.The reusable part

incorporates a lever mechanism for rotating a shaft within a cavity, while the disposable part consists of a pulley with a central cavity and a cannula. The distal end of the reusable part features a socket with a projection that seamlessly fits into the central cavity of the pulley, allowing it to be driven by the shaft within the reusable part.Additionally, the socket in the reusable part includes a plurality of spring-loaded electrical connection pads, which are designed to establish contact with a corresponding plurality of contact pads located on the proximal end of the disposable part. This electro¬mechanical coupling enables the seamless exchange of data and signals between the two parts of the device.Further enhancing the coupling, the socket in the reusable part is equipped with a set of first engagement members, which are designed to engage with a corresponding set of second engagement members located on the proximal end of the disposable part. The combined action of these engagement members, in conjunction with the electrical connection between the pads, results in a secure and efficient connection between the two parts.Moreover, the cannula in the disposable part is constructed with a bending section and a rear end. A set of cable wires is attached to the rear end of the cannula, and when the pulley is rotated by the engagement of the projection with the central cavity on the disposable part's proximal end, the cable wires are pulled from the bending section and wound around the pulley. This action induces bending of the cannula, enabling precise navigation and positioning during ureteroscopy procedures.The single-hand operated two-piece ureteroscope device offers improved flexibility and control during medical procedures, ensuring enhanced performance and patient care.
[0011] 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.

[0012] 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
[0013] 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.
[0014] Embodiment of the present disclosure will now be described, by
way of example only, with reference to the following diagrams wherein:
[0015] Fig 1 illustrates a perspective view of a two-pieceureteroscope
device in accordance with an exemplary embodiment of the present disclosure;
[0016] Figure 2(a) and 2(b) illustrates the perspective view of the two-
pieceureteroscope device in a detached configuration in accordance with an exemplary embodiment of the present disclosure;

[0017] Fig. 3 illustrates sectional view of the two-pieceureteroscope
device with an exemplary embodiment of the present disclosure;
[0018] 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.
[0019] 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
[0020] 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.

[0021] 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.
[0022] 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.
[0023] Referring now to the drawings, Figures. 1-3a single hand
operated two piece endoscope device, in particularly a ureteroscope is illustrated wherein the device comprises of a reusable and a disposable part which are easy to assemble and disassemble in a more efficient and quick manner according to present invention.It should be noted that Figure 1-3 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0024] Referring now to the drawings, Fig. 1illustrates a ureteroscope
device 100 in an attached configuration comprising a reusable portion particularly a handle 102 and a disposable portion 104. The disposable portion 104 has a distal end 106 and a proximal end 108, wherein the disposable portion 104 is adapted to be inserted into a location to be

observed inside a subject. A cannula 110 made up of polyamide braided with metal wires is disposed from the distal end 106 wherein the cannula can be flexible and may include one or more lumens (not shown) along with a bending portion 122 which can be articulated and deflected in any direction along or about longitudinal axis A-A’. A handle 102 of the endoscope device 100 comprising of a distal end 112 and a proximal end 114 is configured to control the movement of cannula 110 in one or more directions relative to longitudinal axis A-A’. The handle 102 is made up of high performance thermoplastics like polysulfone and ergonomically designed to easily operate using one hand by the user. The user can move the bending portion in one or more directionswith the help of a lever 116. In order to detach the handle 102 from the disposable portion 104, an unlock button 118 is provided. Further a working channel 120 is provided on the disposable portion 104.
[0025] Fig. 1is merely an example. A person skilled in the art will
recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The material used in manufacturing of the ureteroscope can be different than the family of high performance thermoplastics like polysulfone and the like as used in the present invention. The material for cannula can be of different material other than polyamide.
[0026] Now referring to Fig. 2(a) and 2(b), the ureteroscope device 100
is illustrated in detachable form. The ureteroscope 100 has a coupling mechanism such that the handle and the disposable portion can be mutually attached and detached from each other wherein the coupling mechanism establishes an electrical interface/connection between the internal components of the handle 102 and the internal components of the disposable

portion 104. The handle 102 comprises of a hollow cylindrical part hereinafter referred as a socket 202 at a distal end 112 of the handle 102 wherein the socket 202 comprises of a plurality of spring loaded electrical connection pads 204 and a projection 206 in the shape of a tapered hexagonal hereinafter referred as driving pin. Further, the socket comprises of a plurality of first engagement members 208 to snap engage the same number of plurality of second engagement members 210 on the proximal end 108 of the disposable portion 104.
[0027] The proximal end 108 of the disposable portion 104 further
comprises of equally same number of plurality of contact pads 212 as of plurality of electrical connection pads 204 to transfer the electrical signals. The contact pads 212 are connected to the electrical outputs (image sensor, pressure sensor and LED lighting via a small timer PCB) that are not shown in the figures. A central cavity 214 is provided in a pulley 312 that is of similar shape to accommodate the driving pin 206. When the first and second engagement members are snap engaged, the driving pin 206 gets inserted in the cavity 214 and the plurality of electrical connection pads 204 on the handle are pressed against plurality of contact pads 212 on the disposable portion 104 eventually forming an electro-mechanical coupling. The main function of electromechanical coupling is to transfer mechanical motion and electronic signals (for image, lighting, pressure).
[0028] 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. Also, the number of engagement members can be more or less than four that are shown in the embodiment.

[0029] Referring now to FIG. 3,the sectional view 300 of the
ureteroscope device 100 is disclosed.The handle 102 comprises of a means 302 (bevel gear) to rotate a flexible shaft 304 at a proximal end 114 of the handle 102 inside the handle cavity 306 when the lever 116 is moved in anticlockwise direction. The disposable portion 104 comprises of two cable wires 308 attached to the rear end of the cannula 310 and are wind around a pulley 312 via a hook 314 as shown inside the disposable part cavity. The flexible shaft 304 is made up of stainless steel braided wire.
[0030] As the lever 116 is moved, the driving pin 206 is driven by the
flexible shaft 304 that carries mechanical motion from the lever 116. As the ureteroscope device 100 has electro-mechanical coupling, this motion is transferred to the pulley 312 due to the insertion of the driving pin 206 into the central cavity 214 provided in the pulley 312.A set of cable wires 308 is attached to the rear end 310 of the cannula 110. The cable wires 308 are pulled from the bending portion 122 and wound around the pulley 312 as the pulley 312 is rotated by the engagement of the said projection 206 with the central cavity 214 on the proximal end 108 of the disposable portion 104, thereby inducing bending of the cannula 110 due to tension in the cable wires 308
[0031] which rotates the pulley 312. The cables 308 gets pulled from the
bending section 122 and wind around the pulley 312 eventually bending the cannula 110 due to the tension of the cables 308. A magnet 316 is housed inside the disposable portion 104 such that when the lever 116 is not in use by user, the magnet 316 holds the pulley 312 to be in a stationary state and does not allow the pulley 312to move in any direction. The unlocking button 118 comprises of a Lock ring that acts like a latching bolt to engage the first

208 and second engagement members 210 thereby locking the reusable 102 and disposable part 104 of ureteroscope 100. The lock ring is constrained for limited motion on the internal surface of the handle socket 202. A Lock spring keeps the lock ring in a fixed position. The Lock Ring works by rotating a fixed amount to accommodate the first 208 and second 210 engagement members of ureteroscope 100 and springs back to locked position.The ureteroscope can be disassembled by pressing the unlock button 118 such that when the unlock button 118 is pressed, the engagement members 208,210 rotates inside the socket 202 and gets disassembled.
[0032] Fig. 3 is merely an example. A person skilled in the art will
recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The mechanism used in this device to move the bending section and the number of cable wires can be altered accordingly. Also, the flexible shaft can be of different material.
[0033] It is observed that the ureteroscope device has provided the
much needed advantage in surgery which avoids any discomfort to the patient as it was the case in conventional methods. Along with these advantages,the ureteroscope can be easily assembled and disassembled such that the disposable portion can be easily replaced with a new disposable portion described in the present invention. Further more,
[0034] The present invention has both technical as well as economic
significance with respect to the conventional ureteroscope devices.
[0035] 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 ureteroscope 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 ureteroscope device and/or elements described herein above while remaining within the scope of the invention.

We Claim:
1. Asingle hand operated two-piece ureteroscope device 100, comprising:
a reusable portion 102 having a lever 116 for rotating a shaft 304 within a
cavity 306 of said reusable portion 102;
a disposable portion 104 having a pulley 312 with a central cavity 214 and a
cannula 110;
a socket 202 on a distal end 112 of the reusable portion 102 comprising a
projection 206 that is adapted to fit into the central cavity 214 of the pulley
312, wherein
the projection 206 is driven by the shaft within the reusable portion 102;
the said socket 202 further comprises of a plurality of spring-loaded electrical connection pads 204 adapted to press against a corresponding plurality of contact pads212 located on a proximal end 108 of the disposable portion 104;
a plurality of first engagement members 208 on the said socket 202 adapted
to be engaged with a corresponding plurality of second engagement
members 210 on the proximal end 108 of the disposable portion 104, wherein
engagement between the first engagement members 208 and the second
engagement members 210, in conjunction with contact between the electrical
connection pads 204 and the contact pads 212, forms an electro-mechanical
coupling; and
the said cannula 110 of the disposable portion 104 has a bending portion 122
and a rear end 310, wherein
a set of cable wires 308 is attached to the rear end 310 of the cannula 110, the
said cable wires 308 are pulled from the bending portion 122 and wound

around the pulley 312 as the pulley 312 is rotated by the engagement of the said projection 206 with the central cavity 214 on the proximal end 108 of the disposable portion 104, thereby inducing bending of the cannula 110 due to tension in the cable wires 308.
2. The single hand operated two-piece ureteroscope device of claim 1, wherein
the electro-mechanical coupling formed by the engagement members 208,210 and the electrical connection pads 204 and contact pads 212 is configured to transfer mechanical motion and electronic signals between the reusable portion 102 and the disposable portion 104.
3. The single hand operated two-piece ureteroscope device of claim 1, wherein
the electro-mechanical coupling facilitates the transfer of mechanical motion from the reusable portion 102 to the disposable portion 104, thereby enabling the rotation of the pulley 312 in the disposable portion 104 by operating the lever 116 in the reusable portion 102.
4. The single hand operated two-piece ureteroscope device of claim 1, wherein
the electro-mechanical coupling further enables the transmission of electronic signals between the reusable portion 102 and the disposable portion 104, including signals related to image capture, lighting control, and pressure monitoring.
5. The single hand operated two-piece ureteroscope device of claim 1, wherein
the engagement between the first engagement members 208 and the second engagement members 210 is configured to allow for rapid and secure assembly and disassembly of the reusable portion102 and the disposable portion 104 using an unlocking button 118, enhancing the usability and maintainability of the ureteroscope.
6. The single hand operated two-piece ureteroscope device of claim 1, wherein
the projection 206 on the said socket 202 of the reusable portion 102 is of a tapered hexagonal geometry.