FIELD OF INVENTION

[0001] The present invention relates to an integrated irrigation-suction device. More particularly, to an integrated irrigation-suction cannula with electronic control for irrigation and suction for use in microneurosurgery and similar fields of small bore sizes surgical area.

BACKGROUND OF INVENTION [0002] Microneurosurgery is an extremely complex procedure which requires proper coordination among various surgical tools being used. Irrigation and suction are two of the most frequently performed procedures during a surgery to locate bleeding points and remove excess fluid from the operating site. There are several integrated irrigation-suction devices that exist in prior art in which the irrigation flow rate is controlled by pressing a mechanical switch (present on the device) using the thumb or forefinger. This functionality is only available in endoscopes which play no significance in microneurosurgeries. There exist several disadvantages in the existing integrated irrigation-suction devices such as musculoskeletal fatigue induced in the palm due to non-ergonomic and bulky design, limited adjustability in length or bore of the irrigation- suction cannula, requirement of much activation force for the irrigation switch which compromises grip on the device and dexterity of micro-manipulation being performed with the suction cannula when operated for long hours. Moreover, the user controlled variability in sensitivity of the activation mechanism and the irrigation flow rate is lacking within the existing devices.

[0003] Another device known in prior art is Delta Irrigation Sucker which is also having a mechanically operable switch needed for the activation of irrigation mechanism that further increases the musculoskeletal strain. [0004] Another device known in prior art is Opto Irrigator which incorporates both suction and irrigation and uses an optical switch for actuating the irrigation mechanism. The optically controlled switch is a fragile and expensive option for initiating the irrigation mechanism. It raises the device cost and has a hidden consumable cost for the optical fiber. The sensitivity of the touch sensing optical mechanism cannot be adjusted by the user. The irrigation mechanism involves a peristaltic pump which is also expensive. [0005] Similarly, another device existing in prior art is the Controlled Suction with

Venous Catheter Irrigation device. In this existing device venous catheter is inserted into a normal Frazier Suction Tube through its suction control pore and upon pressing the thumb against the tube, irrigation stops and suction starts and vice-versa. The major drawbacks of this design are: (i) the venous catheter partially blocks the suction cannula reducing the bore of the suction channel;

(ii) Flow control is difficult to maintain as a single thumb press controls both irrigation as well as suction. [0006] Another device in prior art is the microsurgical pressure-irrigation-suction system (MPIS) that allows a rapid adjustment of suction and irrigation to the operative situation by one-hand manipulation. Flowever, this cannot be used for micro level surgery as it only enables power grip, which is fundamentally different from the precision grip needed for delicate manipulation of tissues during surgeries performed under the microscope.

[0007] Another multi-functional electrosurgery system of existing prior art is ENDOPATH Probe Plus II that facilitates tissue dissection, coagulation, irrigation, and fluid evacuation. The complete system is designed to meet a wide variety of surgical needs such as one-handed use which increase surgical efficiency through less instrument exchanges but the major drawback is that it is intended only for endoscopic surgical procedures and is not suitable for surgeries performed under the operating microscope. [0008] Further, interchangeable combined irrigation suction devices are also available in prior art where the arrangement includes two tubes for irrigation and suction respectively but said both tubes form a single body and can’t be detached from each other. These devices have a very crude and primitive mechanism for controlling the irrigation, often obligating the surgeon to change the position of his/her grip around the device or involving an assistant.

[0009] US20150335813A1 discloses a surgical irrigation and suction apparatus including a removable tube divided into an irrigation chamber and a suction chamber and the flow of fluids in respective chamber is controlled via thumb actuation of a respective pinch valve. In this prior art the pinch valve is in the shape of a wheel having an axis confined within a groove and user rotates the pinch valve using her thumb to force the wheel's axis to move along the groove for opening of the corresponding tube for transporting the fluid within. However, rotating the wheel is not a convenient control mechanism for modifying the strength of the suction and/or irrigation during surgical procedures as it needs high fine motor skills to switch between suction and irrigation modes, while simultaneously other treatments have to be completed. Hence compromising the absolute stability needed for micro surgical operations.

[0010] Another prior art document WO2012069592A1 discloses a suction and irrigation device comprising a valve body with an irrigation passage and a suction passage. The valve is adjusted to different position through a push button movable by mechanical force for opening and closing of irrigation & suction. Thus, this device allows for a simple operation of the device. However, the push button comprises a movable element as an elastically deformable element, which is deformable by mechanical force acted upon and in some cases when magnitude of force applied is more the switch or valve may lead to shivering of the hand and therefore of the suction and irrigation device. This can disturb or interrupt the treatment and even increase surgical risk, if the instrument is used together with a surgical microscope and therefore small movements of the instrument may lead to unwanted excursions in microscopic view. Further, elastically deformable element of the push button is subject to wear and tear with time. [0011] In another prior art document US9314554B2 a handpiece usable in an irrigation and suction system, in particular for laparoscopic surgery is disclosed. Said handpiece includes a pair of pressable buttons contiguous with each other on its distal face for controlling the operation of the suction valve and irrigation valve respectively. However, this device is not usable in microsurgical applications.

[0012] US7540873B2 discloses a four function microsurgery instrument performing the functions of aspiration, irrigation, dilation and cauterization. The instrument includes a common conduit consisting two separate conduits, co-axial conduits with two channels and side-by-side conduit strips with one delivering fluid and the other suction. The function provided by the conduit is determined by an irrigation-fluid and aspiration-suction control and transmission system which consists of a plunger valve for actuation by a user for controlling both irrigation-fluid and aspiration-suction. This device however is only suited for very specific microsurgical applications such as vessel anastomosis. The suction channel is having insufficient caliber for replacing the suction irrigation steps needed during diverse microsurgical applications.

[0013] In US20170119939A1 a lavage handle for facilitating an irrigation function and a suctioning function at a target zone is disclosed. The disclosed handle consists of a power operated actuation mechanism which includes a pressure-sensitive contact in communication with the deformably resilient material for controlling fluid displacement such as irrigation and/or suction. The actuation mechanism when squeezed a first time activates the fluid-displacing mechanism and thereafter when squeezed a second time deactivates the fluid-displacing. This lavage handle is not suitable for use during surgical procedures performed under the microscope.

[0014] The need therefore remain, for a solution which can overcome the limitations & disadvantages of prior art and in this view the present invention provides an integrated irrigation-suction device wherein irrigation is controlled electronically via a sensor acting as a touch-activated switch. Hence much less force required to operate it making the device ergonomic, easy to use, efficient and well suited to the delicateness required during surgeries performed with the help of operating microscope . SUMMARY OF THE INVENTION

[0015] The present invention is an integrated irrigation-suction device (100) comprising: a) a handpiece (10) consisting of (i) an integrated irrigation-suction cannula (11) being a cylindrical tube with a tapered end and internally partitioned to divide it asymmetrically into two halves (11 A , 11 B ), one being an irrigation halve (11 A) and another being a suction halve (11 B) (ii) a handle (21) with three openings

- first opening detachably accommodating said cannula (11) at its non- tapered end,

- second opening being a closed channel connecting irrigation halve (11 A) to a flexible irrigation tube (1 A) connected to an IV fluid source (1) ,

- third opening being a perforated channel connecting suction halve ( 11 B) to a suction tube (2A) of a suction pump (2) for allowing control of suction through suction halve (11 B) by partially or fully closing or opening of the perforation (23), and housed thereon with an electronic switch (22) for generating a signal proportionate to the force exerted on the switch (22), b) an irrigation controller (30) having

- an flow control valve (31) holding the irrigation tube (1A),

- a PCB connected to electronic switch (22) for receiving and processing the signal from said switch to actuate the flow control valve (31) and compress or decompress the irrigation tube (1A) to control the irrigation flow rate through the irrigation halve (11 A), and ports (33, 34) for receiving input signal from the electronic switch (22) and power supply respectively, wherein the irrigation controller (30) is a detachable unit consisting of a grip handle (35) for holding the unit while attaching, detaching and easy portability, and a pair of mounting brackets (36) for mounting the entire controller unit onto the operating table.

[0016] The integrated irrigation-suction device of present invention also consists a knob (32) for controlling the sensitivity of the electronic switch (22). [0017] Various aspects of the present invention herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF DRAWINGS

[0018] The embodiments herein will be better understood from the following detailed description with reference to the drawings, in which the reference numerals indicate:

[0019] Fig. 1 illustrates the overall working assembly of the integrated irrigation- suction device (100) of the present invention;

[0020] Fig. 2 illustrates the assembly of the integrated irrigation-suction device (100) of the present invention; [0021] Fig. 3 illustrates the sectional view of handpiece (10) of the integrated irrigation-suction device (100) of the present invention;

[0022] Fig. 4 illustrates the exploded view of handpiece (10) of the integrated irrigation-suction device (100) of the present invention; and

[0023] Fig. 5 illustrates the irrigation controller (30) of the integrated irrigation- suction device (100) of the present invention.

DETAILED DESCRIPTION

[0024] To explain specifically, the integrated irrigation-suction device (100)of present invention comprises a handpiece (10) consisting of (i) an integrated irrigation- suction cannula (11) being a cylindrical tube with a tapered end and internally partitioned to divide it asymmetrically into two halves (11 A , 11 B ), one being an irrigation halve (11 A) and another being a suction halve (11 B) and (ii) a handle (21) with three openings in which first opening is for detachably accommodating said cannula (11) at its non-tapered end, second opening being a closed channel connecting irrigation halve (11 A) to an irrigation tube (1 A) of an IV fluid source (1), and third opening being a perforated channel connecting suction halve ( 11 B) to a suction tube (2A) of a suction pump (2) for allowing control of suction through suction halve (11 B) by partially or fully closing or opening of the perforation (23). In the present invention further an electronic switch (22) is housed on the handle (21) to generate a signal proportionate to the force exerted on the switch (22).

[0025] The integrated irrigation-suction device of present invention also comprises an irrigation controller (30) having a flow control valve (31) holding the irrigation tube (1A) via slot, a PCB connected to said electronic switch (22) for receiving and processing the signal from said switch to actuate the flow control valve (31) and compress or decompress the irrigation tube (1A) to control the irrigation flow rate through the irrigation halve (11 A), and ports (33, 34) for receiving input signal from the electronic switch (22) and power supply respectively. The irrigation controller (30) is a detachable unit consisting of a grip handle (35) for holding the unit while attaching and detaching, and a pair of mounting brackets (36) for mounting the entire controller unit onto the operating table.

[0026] In the present invention the integrated irrigation-suction cannula (11) and handle (21) together constitutes the handpiece (10) which is held in the hand during operation.

[0027] The integrated irrigation-suction device (100) of present invention further consist a knob (32) for controlling the sensitivity of the electronic switch (22). [0028] In a preferred embodiment the handle (21) being detachable from cannula (11) has a locking mechanism for accommodating and fitting of cannula (11) into the handle (21). The locking mechanism of the detachable cannula (11) can be of any type that is leak-proof and provides enough strength to resist bending during operation.

[0029] In a preferred embodiment the electronic switch (22) is a touch responsive button or touch activated switch preferably a force sensor for controlling the irrigation flow and the perforation (23) is a tear drop shape cavity for controlling the suction rate. Further the switch (22) can be any type of electronic switch utilizing minimum or zero activation force, unlike mechanical switches and the sensor can be a force sensor, touch sensor, ambient light sensor, etc., for controlling irrigation.

[0030] In a preferred embodiment the force sensor (22) can be accommodated on the handle (21) of the device in a detachable tray form for enabling separate sterilization for the electronic and non-electronic parts and also for easier handling.

[0031] In a preferred embodiment the flow control valve (31) is an electric-operated pinch valve. Further electric-operated pinch valve (31) and PCB are assembled inside the irrigation controller (30). The force sensor (22) is connected to PCB via a wire which transfers the signal from force sensor (22) to PCB when it is touched. The signal transferred from force sensor (22) to PCB is in the form of voltage deflection generated on touching the force sensor (22). The activation force required to be exerted on sensor (22) for generation of signal by the sensor is adjusted by a knob (32) mounted on PCB.

[0032] In another preferred embodiment the integrated irrigation-suction cannula (11) is mounted with an illumination source (12) on its outer surface by a built in casing. The illumination source (12) illuminates the region that needs to be operated which enables ease of operation where adequate amount of light is not provided. According to an embodiment the Illuminating source (12) can be of any type such as but not limited to LED. Additionally, it can be placed anywhere within the cannula (11) for providing focused beam at the surgical field. [0033] In a preferred embodiment the integrated irrigation-suction cannula (11) of present invention can be used in any microsurgical application apart from microneurosurgery, such as micro level ENT and dental surgery, with slight or no modifications.

[0034] For functioning of the integrated irrigation-suction device (100) of the present invention, the user has to touch the electronic switch (22) to activate the irrigation through the irrigation halve (11 A) of the cannula (11), on touching switch (22) the irrigation fluid is supplied to the irrigation halve (11 A) from IV fluid source (1) via an irrigation tube (1a), the irrigation tube (1a) passes through the irrigation controller (30) which compresses and decompresses the irrigation tube (1a) to control flow rate.

[0035] The other halve known as suction halve (11 B), to activate suction at suction halve (11 B) the user has to cover the perforation (23) with the thumb. Constant suction is performed by a suction pump (2), when suction is not needed the air suction is done through the perforation (23), when suction is required the user covers the perforation (23) with his thumb and suction is done from the suction halve (11 B) of cannula (11 ).

[0036] The overall view of the integrated irrigation-suction device (100) constructed according to one of the preferred embodiment of invention is depicted in FIGURES 1 to 2, for explaining the components of the device. Referring now to the FIGURES, more particularly to FIGURES 1 to 2, where similar reference characters denote corresponding features consistently throughout the FIGURES, preferred embodiments are shown.

[0037] Fig. 1 illustrates the overall working assembly of the integrated irrigation- suction device (100) constructed according to one of the preferred embodiment of invention, which consists of an IV fluid source (1) with an irrigation tube (1a), a suction pump (2) with a suction tube (2a), a handpiece (10) consisting of an integrated irrigation-suction cannula (11) being a cylindrical tube with a tapered end and a handle (21), an irrigation controller (30) having an electric-operated pinch valve (31) holding the irrigation tube (1a) via slot, and a PCB. The IV fluid source (1) with an irrigation tube (1a), a suction pump (2) with a suction tube (2a) are part of prior art which are included herein only to depict the overall working assembly of the integrated irrigation- suction device (100) of present invention.

[0038] Fig. 2 illustrates the assembly of the integrated irrigation-suction device (100) constructed according to one of the preferred embodiment of invention, which comprises a handpiece (10) consisting of an integrated irrigation-suction cannula (11) being a cylindrical tube with a tapered end, and a handle (21), an irrigation controller (30) having an electric-operated pinch valve (31) holding the irrigation tube (1a) via slot, a PCB, and ports (33, 34) for receiving input signal from the force sensor (22) and power supply respectively, wherein the PCB also consists a knob (32) to control the sensitivity of the force sensor (22).

[0039] Fig. 3 & 4 illustrates sectional and exploded view of the handpiece (10) constructed according to one of the preferred embodiment of invention, which consists of an integrated irrigation-suction cannula (11) being a cylindrical tube with a tapered end and internally partitioned to divide it asymmetrically into two halves (11 A , 11 B ), one being an irrigation halve (11 A) and another being a suction halve (11 B), and a handle (21) with three openings, first opening detachably accommodating said cannula (11) at its non-tapered end, second opening being a closed channel connecting irrigation halve (11 A) to the irrigation tube (1A) of the IV fluid source (1), third opening being a perforated channel connecting suction halve (11 B) to the suction tube (2a) of the suction pump (2) and allowing control of suction through suction halve (11 B) by partially or fully closing or opening of the perforation (23), and housed thereon with a force sensor (22) to generate a signal proportionate to the force exerted on the sensor (22).

[0040] Fig. 5 (a & b) illustrates the irrigation controller (30) of the integrated irrigation-suction device (100) constructed according to one of the preferred embodiment of invention, which consists of an electric-operated pinch valve (31) holding the irrigation tube (1a) via slot, the PCB with the knob (32) that control the sensitivity of the sensor (22), ports (33, 34) for receiving input signal from the sensor (22) and power supply respectively. According to an embodiment of present invention the irrigation controller (30) is a detachable unit which consists of a grip handle (35) for holding the unit while attaching and detaching, and a pair of mounting brackets (36) for mounting the entire controller casing onto the operating table without requirement of any additional accessory. [0041] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope.