DESC:FORM 2
THE PATENT ACT 1970
(39 OF 1970)
&
THE PATENT RULES, 2003
PROVISIONAL SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION: FLEXIBLE AND PARTIALLY DISPOSABLE MEDICAL DEVICE

Applicant
(a) Name: Biorad Medisys Pvt. Ltd.
(b) Nationality: Indian
(c) Address: Survey No. 48/3 and 48/7
Pashan Sus Road, Sus Village
Taluka Mulshi
Pune-411021
Maharashtra

PREABMLE TO THE DESCRIPTION

FIELD OF THE INVENTION:

This present invention generally relates to medical devices to visualize and examine the interior of human through natural orifices. More particularly, the invention relates to a medical device to visualize and examine the interior of human anatomy through natural orifices with enhanced portability by providing a disposable sheath and a detachable visio-optical cover.

BACKGROUND OF THE INVENTION:

Different types of scopes are commonly used in variety of procedures in which the physician must visually examine an internal portion of the body. Cystoscopes, in particular, are used by urologists to examine the urethra and bladder to diagnose urethral, prostate and bladder abnormalities. Different types of scopes enables the internal regions of the human anatomy likewise urinary system and adjoining organs to be inspected, without the need of painful incisions, by enabling the viewer to insert a distal portion of the scope through the urethra from whence it is moved to its final location within the urinary tract. These devices are expensive and they are used in a contaminated environment for a brief procedure (5-10 minutes).Typically, these scopes have a flexible insertion tube that is inserted into patient during the procedure, commonly cystoscopes are utilized to perform such visual examination to visualize and examine urethra, bladder, ureter and other adjoining areas. The cystoscopes also have multiple channels that extend along the length of the cystoscope and come into contact with body tissues and fluids during the procedure. These cystoscopes having integral working channels along the neutral bending plane are severely contaminated during an cystoscopic procedure.
Proper cleaning and sterilization of the insertion tube is very laborious and costly thereby reducing the cost effectiveness of performing the therapeutic or diagnosis procedures. Disposable endoscopic or cystoscopic or like sheaths have been developed to alleviate the problem of cleaning and sterilizing the working channels. The disposable sheaths fit over the insertion tube from the contaminating environment. The isolated insertion tube may not have integral working channels, but may contain a visual imaging device, illumination devices and the control wires that bend the insertion tube’s distal end. Working channels, such as air, water, and biopsy/suction channels are disposed within the sheath adjacent to the isolated insertion tube and are open to the sheath’s distal end to allow passage of air, water, suction or endoscopic accessories through the channels.
All current endoscope or cystoscope or like are either straight and require exchanging rigid fiber-optic lenses with different viewing angles in the axis of the instrument, or flexible with manual mechanical, off axis, directional control of the tip optics that have a fixed field of view. Complete examination, for example in case of urinary system is achieved by filling (expanding) the urethra and bladder with clear fluids while the operator visually guides the instrument and using the combination of angular and longitudinal manipulation to visualize the entirety of the urethra and bladder’s mucosal surface. Cystoscopes may come with optics for direct visualization by the operator, or, increasingly with a built-in camera or a method for camera or a method for camera attachment for real time viewing of digital images on a monitor, and possibly still or video photography. Cystoscopes have become highly developed for physician use over the past 100 years, with major development in lighting, optics and procedural versatility. In general, they are re-usable and have been persistently expensive to buy, re process and maintain.
There are quite a few barriers likewise, the skill and time it takes to manipulate the optics at the instrument tip for complete visualization of the mucosal surface of the bladder and urethra, the cleaning and re-sterilization requirement before every use, that should be addressed to reduce the global time and expense of cystoscopic examination.
Vision Sciences, Inc.. Offers disposable sheaths under trademark Endosheath® for a flexible cystoscope in an attempt to escape the re-processing/sterilization step and have patents relating to disposable sheaths.
US 8622893 has disclosed a re-usable handle containing the electronics and input port for fluids that is then attached to a disposable conduit and optical tip. This kind of arrangement allows user to avoid the re-sterilization equipment for the portion of the equipment that contacts the patient.
US 20150216403 discloses a catheter endoscope for deployment in the bladder of a patient to provide a visual display of the bladder’s mucosal surface. The method comprises providing a catheter endoscope comprising an elongated member, an image acquisition component and an expandable positioning component.
US 20070270646 discloses a disposable sheath to be used in conjunction with a cystoscope or endoscope, wherein the sheath has a redirecting portion that preferably directs the cystoscope accessory toward a working end of the cystoscope.
US 20180140177 discloses a flexible digital ureteroscope that is atleast partially disposable. The scope’s insertion tip is a rigid or semi-rigid structure having a small diameter, which reduces pain or discomfort when being inserted into patient’s urinary tract. The invention is aimed to reduce manufacturing cost of the scope, making it possible to dispose at least the catheter part of the scope, which greatly reduces the risk of cross-infection caused by incomplete sterilization.
Accordingly, in the prior arts discussed above, problems exist, however in the use of conventional cystoscopes, for example after each successive procedure, conventional cystoscopes must be cleaned and sterilized before the next use, which delays successive procedures. Furthermore, conventional cystoscopes are non-disposable or partially disposable and requires extensive and expensive maintenance. Sterilization delays and costs associated with purchasing and/or repairing cystoscopes have escalated costs for cystoscopic procedures and related medical procedures. The medical device of the present disclosure are directed to improvements in the existing technology.

OBJECTS OF THE INVENTION:

It is an object of the invention to provide a novel medical device to visualize and examine the interiors of urethra, bladder, not limited to and likewise, having a separable handle with an articulation knob, a connectible elongate member and a detachable visio-optical source with a disposable cap.
It is another object of the invention to provide a medical device with an elongate member, to be able to detachably engage with handle, in order to minimize the risk of infection during the usage of the medical device.
It is another object of the invention to provide a medical device with a detachable visio-optical source covered with a disposable cap, compatible to be used with other type of medical devices.
It is another object of the invention to provide a novel medical device, that is compatible, cost-effective and easy to use by person skilled in the art.
Still further objects and advantages will become apparent from a consideration of the ensuring description and drawings.

SUMMARY OF THE INVENTION:

In accordance with these objects which will be discussed in detail below, the medical device of the invention generally includes: a reusable handle, an elongate member, and detachable visio-optical source covered with a disposable cap, adapted to be used to visualize and examine the interiors of the urethra, bladder and adjoining areas, not limited to.
One aspect of this invention is to provide a medical device configured for deployment in the body of a patient to provide an image of the mucosal surface of the patient’s urethra and bladder for display on an externally located display device comprising a handle with an articulation knob, separably attached to an elongate member, wherein the proximal end of the said elongate member detachably engages with handle, and distal end of the said elongate member is connected to detachable visio-optical source covered with a disposable cap.
Further according to the objects of the invention, the invention provides a flexible medical device that is at-least partially disposable, that also reduces the manufacturing cost of medical device by making it possible to dispose the elongate member part of the medical device, which greatly reduces the risk of the cross infection caused by incomplete sterilization.
In another aspect of the invention, the handle is a reusable handle which may contain a compact battery power source, for supplying electric power to light source and the image sensor chip, a printed circuit board, and/or a wireless communication module for transmitting image data to the host machine. In this case the handle-elongate member connector can removably connect the handle with the elongate member.
In accordance with an embodiment, a medical device may comprise an elongate member and a handle assembly connected to the elongate member, and a visio-optical source detachably with disposable cap, connected to the elongate member. The handle housing may house a steering mechanism movable relative to the handle assembly and configured to steer the elongate member, a detachable camera and illumination system configured to provide illuminating light and capture images. The medical device may also comprise a connector configured to operably connect the medical device to a control module including one or more processing units for operating the camera system and the illumination system, wherein the connector may be configured to directly connect to and disconnect from the handle assembly.
In accordance with another embodiment, an elongate member for a medical device may comprise a combination of layers of material configured to provide pushability, passive and active deflection of the elongate member.
Various embodiments of the disclosure may include one or more of the following aspects: the medical device comprises a detachable visio-optical source, covered with a disposable cap, that may house one or more illumination units, an image sensor, and an elongate member comprising a working channel; wherein the elongate member may include an inner layer of a coiled material, a middle layer of a braided materialand an outer layer of a polymeric material.
In this respect, before explaining multiple embodiments of the present disclosure in detail, it is to be understood that the present disclosure is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The present disclosure is capable of embodiments in addition to those described and of being practicable and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.

BRIEF DESCRIPTION OF THE DRAWINGS:

The foregoing aspects and other features are explained in the following description taken in connection with the accompanying drawings:
Figure 1 shows the perspective view of the medical device.
Figure 2 shows the perspective view of the handle assembly of the said medical device.
Figure 3 shows the perspective view of the detachable visio-optical unit of the said medical device.
Figure 4 shows the perspective view of the disposable elongate member of the said medical device.

DETAILED DESCRIPTION OF THE INVENTION:

Reference will now be made in detail to the different embodiments, of the present disclosure described above an illustrated in the drawings
The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of medical device. When used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to the physician, or other user, using the medical device. In contrast, “distal” refers to a position relatively further away from the surgeon, or other user, using the medical device or closer to the interior of the body.
Figure 1 illustrates a medical device 10, according to a preferred embodiment of the present invention. Medical device 10, is a device configured to allow an operator to access and view internal body anatomies of the patient. Medical device 10, is insertable into a body lumen or cavities such as for example, any portion of urinary tract like urethra, bladder and like, not limited to.
For the purpose of the present disclosure, medical device 10 is a sterile, partially disposable cystoscope. Other types of devices, however may be substituted for cystoscope including as examples, an endoscope, a ureteroscope and like.
Cystoscope 10, includes a handle assembly 11, an elongate member 12, operably connected to handle assembly 11, and a detachable visio-optical source 13, wherein the detachable visio-optical source 13 is further covered with a disposable cap 14, and a bending portion 15 towards the distal end of the elongate member 12. Elongate member 12, a disposable sheath include one or more portions that are flexible, to allow elongate member 12, to be manoeuvred within the body and traverse tortuous anatomical lumen's. For instance, elongate member 12, may be uniformly flexible or may include a plurality of portions having varying degrees of flexibility or rigidity. An image sensor 133, and an illumination unit 135, may be located at detachable visio-optical source 13, wherein the whole visio-optical source 13 unit is covered with a disposable cap 14. Image sensor 133 is configured to capture images and/or full-motion video images. Illumination unit 135 is configured to illuminate internal body pathways and/or cavities of a patient.
Handle assembly 11, may include a handle housing 111, an articulation knob 112 configured to control the steering and deflection of the elongate member 12 with the help of steering mechanism 113 operably coupled. It also includes an printed circuit board 114 comprising of data and image processor 115, a connector 116 configured to operably connect and disconnect the cystoscope 10 to a suitable control module 14, as shown in Figure 2.
Figure 3 illustrates a detachable visio-optical unit 13 further covered with a disposable cap 14, wherein the detachable visio-optical unit 13 further includes a camera system 131, an illumination system 132. It further illustrates a system wherein camera system 131, and illumination system 132 may form a single operating unit. In other words, a single connector 116 may communicate image and illumination data between the suitable control module 14 and camera system 131 and illumination system 132. Camera system includes an image sensor 133, and one or more electrical wires unit 134. Image sensor 133 can be any suitable type of image sensor configured to capture images and/or full-motion video images in digital or any other suitable format, such as, for example a camera including a charged couple device (CCD) or a CMOS image sensor. The detachable visio-optical source 13 unit is covered with a disposable cap 14 in order to facilitate easy detachment of the visio-optical source 13 unit from the elongate member 12, while facilitating the removal and replacement of the elongate member 12 from the cystoscope 10 and also to reduce and minimize the chances of cross-infection while performing the examination, wherein the disposable cap 14 can be disposed off once the examination is done, and same set of detachable visio-optical source 13 can be used again for performing next set of examination.
One or more electrical wires unit 134 may be operably coupled to image sensor 133 and connector 116. Thus, image data captured by image sensor 133 may be transmitted through one or more electrical wires unit 134 through connector 116 and to the control module 14. Data and image processor 115, as disclosed in Figure 2, is configured to calibrate the captured images based on the commands from the control module 14.
Further, the illumination system 132 includes an illumination unit 135 operably connected to connector 116. For the purposes of the present disclosure, illumination unit 135 may include light emitting diodes
As illustrated in Figure 2, connector 116 operably connects handle assembly 11 to control module 14 and provide a communication pathway between control module 14 and both camera system 131 and illumination system 132. For example, connector 116 provides electronic signalling pathways for image sensor 133 to transmit image data to control module 14, for control module 14 to transmit the image control signals to image sensor 133 and data and image processor 115, and for control module 14 to control light delivered from illumination source 117. Illumination source 117 is housed within handle assembly 11 operably connected with each other, which further is operably connected to control module 14 via connector 116.
Connector 116 may include any appropriate linkage configured to provide signalling capabilities and communication between control module 14 and both camera system 131 and illumination system132 , such as, for example, one or more electrical wires, an electrical conduit, and the like. Connector 116 may also include a suitable structure configured to readily attach to control module 14 and detach from control module 14, such as, for example, a detachable point-to-point adapter, a detachable splice, and a detachable multi-port adapter. Accordingly, connector 116 may operably link cystoscope10 to control module 14 when, for example, performing a procedure utilizing camera system 131 and illumination system 132 , and may readily detach cystoscope10 from control module 14 when, for example, the procedure is completed. Connector 116 may be fixed to handle assembly 11, and thus, the entire cystoscope10 may be attached and detached from control module 14 by connecting and disconnecting connector 116 from control module 14.
Figure 4 illustrate elongate member 12, with a bending component 15 towards the distal end of the elongate member 12according to an exemplary embodiment. Elongate member 12 may vary in stiffness across its length. Such a configuration may minimize compression and twisting of elongate member 12 to allow elongate member 12 to be easily advanced through body cavities or lumens, while also providing deflection of distal portion 122. Elongate member 12 may also include a hub interface 123 disposed on proximal end 121 of elongate member 12. Hub interface 123 may connect elongate member 12 to handle assembly 11 and may provide torsion and tensile strength at the connection point between elongate member 12 and handle assembly 11.
As shown in figure 4, elongate member 12 may include materials configured to provide pushability, stiffness, and kink resistance to elongate member 12. For example, elongate member 12 may include a reinforcement sheath 124, encased by outer sleeve 125. Reinforcement sheath 124 may include a coiled configuration of tightly wound flat wire or polymeric elements. The coiled configuration may provide column strength and torsional rigidity to elongate member 12 which may allow elongate member 12 to be advanced through body lumens and/or cavities. The coiled configuration may also provide kink resistance to prevent it from collapsing due to bending forces.
Further, a working channel 16 may extend longitudinally through handle assembly 11, and elongate member 12, in continuation when handle assembly 11 and elongate member 12 are connected through hub interface 123.
Any aspect set forth in any embodiment may be used with any other embodiment set forth herein. Every device and apparatus set forth herein may be used in any suitable medical procedure, may be advanced through any suitable body lumen and body cavity, and may be used for treatment of any suitable body portion. For example, the apparatuses described herein may be used in any natural body lumen or tract, including those accessed orally, vaginally, or rectally.
The many features and advantages of the present disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the present disclosure which fall within the true spirit and scope of the present disclosure in complete specification. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the present disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the present disclosure.
,CLAIMS:I/We Claim:
1. A medical device comprising:
a reusable handle with an articulation knob;
a disposable elongate member; and
detachable visio-optical source with a disposable cap, wherein the medical device is adapted to be used to visualize and examine the interiors of the body.
2. The medical device as claimed in claim 1, wherein the said device comprises a handle with an articulation knob, separably attached to an elongate member, wherein the proximal end of the said elongate member detachably engages with handle, and distal end of the said elongate member is connected to detachable visio-optical source covered with a disposable cap.
3. The medical device as claimed in claim 1, wherein the said device is a partially disposable flexible medical device wherein the said elongate member is disposable.
4. The medical device as claimed in claim 1, wherein the said handle is a reusable handle that further comprises:
a compact battery power source;
a light source; and
an image sensor chip
5. The medical device as claimed in claim 4, wherein the said reusable handle comprises a compact battery power source to supply electric power to light source, and the said image sensor chip, a printed circuit board and/or a wireless communication module for transmitting image data to host machine.
6. A medical device comprising an elongate member and a handle assembly connected to the elongate member and a visio-optical source detachably with disposable cap, connected to the elongate member, wherein the handle housing comprises a steering mechanism movable relative to the handle assembly and configured to steer the said elongate member, a detachable camera and illumination system configured to provide illuminating light and further to capture the images.
7. A medical device as claimed in claim 6, wherein the said medical device comprises a connector configured operably to connect the said medical device to a control module that further include one or more processing units for operating the said camera system and the said illumination system, wherein the said connector may be configured to directly connect to and disconnect from the said handle assembly.