Abstract: The present invention relates to an irrigation control system and method for monitoring and controlling pressure inside a patient’s body. The system includes a user interface configured to operate a plurality of operations of the system, at least one pressure sensor configured to sense a pressure inside the patient body cavity and alerting the system for closing an inlet valve, at least one flow sensor configured to sense flow of fluid to the patient’s body, a suction port for controlling suction of the fluid, and a controller encoded with instructions enabling the controller to function as a simulator configured to emulate a closed working enclosure by closing an outlet valve of the system using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and flow sensor to determine appropriate functioning of the device before every single application, wherein the at least one pressure sensor and flow sensor are operatively coupled to the controller for enabling the system to self-approve use for surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the system to ascertain appropriate functioning.
The present invention relates to medical devices and systems. More particularly the invention relates to irrigation system and method for controlling pressure inside patient body.
BACKGROUND OF INVENTION
Surgical procedures such as urological, gynecological, and laparoscopic surgeries are performed through a small incision or natural orifice. Such procedures may require sterile water to clear and/or distend the surgical site. However, certain additional considerations pertain when fluid is delivered to a surgery that is performed through a small incision or natural orifice. For example, it is important to be sure that too much pressure does not build up inside the body. Also, it may be important to know how much fluid has been delivered to the surgical site to be sure that fluid has not been accumulating inside the body. Generally, when surgeons insert the investigational or operative instrument inside the body, there is leak of saline or absorption of saline inside the body. Due to this pressure drops inside the bodily cavity such as uterus or bladder.
Irrigation and Suction system or pumps for delivery of fluid are well known for medical procedures. However, certain types of pumps used in these systems, such as positive displacement pumps, may have a potential disadvantage since pressure control failure could result in damage to the internal organs of the patient.
Accordingly, there is a need for an irrigation system that is inexpensive to produce and use, that provides the physician with important information regarding the delivery of controlled amounts of irrigation fluid, and which is safe so that the pressure generated is not harmful to the patient.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides an irrigation control system and method for monitoring and controlling pressure inside a patient’s body. The system includes a user interface configured to operate a plurality of operations of the system, at least one pressure sensor configured to sense a pressure inside the patient body and alerting the system for closing an inlet valve when desired pressure is reached, at least one flow sensor configured to sense flow of fluid to the patient’s body, a bubble detector to detect formation of bubbles in fluid , a suction port for controlling suction of the fluid, and a controller encoded with instructions enabling the controller to function as a simulator configured to emulate a closed working enclosure by closing an outlet valve of the system using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and flow sensor to determine appropriate functioning of the device before every single application, wherein the at least one pressure sensor and flow sensor are operatively coupled to the controller for enabling the system to self-approve use for surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the system to ascertain appropriate functioning.
In an embodiment the present invention provides an irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device comprising at least one pressure sensor, at least one flow sensor, a user interface, a suction port and a controller. The method includes testing functioning of the pump device by emulating a closed working enclosure by closing an outlet valve of the pump using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and the flow sensor to determine appropriate functioning of the pump before every single application, and in response to sensing a pressure inside patient body cavity, alerting the device for closing an inlet valve, wherein the device self-approves use for a surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the device to ascertain appropriate functioning of the device.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1A shows a block diagram of an irrigation control system 100 for monitoring and controlling pressure inside a patient’s body in accordance with embodiment of the present invention.
Fig 1B shows a block diagram of an embodiment of an irrigation control system 100 for monitoring and controlling pressure inside a patient’s body in accordance with embodiment of the present invention.
Fig. 1C shows front view of a user interface of the system in accordance with an embodiment of the present invention.
Fig. 1D shows a perspective view of system with interconnections in accordance with an embodiment of the present invention.
Fig. 2, shows a flowchart depicting an irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device comprising at least one pressure sensor, at least one flow sensor, a user interface, a suction port and a controller in accordance with an embodiment of the present invention.
Fig. 3 shows a detailed example flowchart depicting the irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Various embodiment of the present invention provides an irrigation system and method for controlling pressure inside patient body. The following description provides specific details of certain embodiments of the invention illustrated in the drawings to provide a thorough understanding of those embodiments. It should be recognized, however, that the present invention can be reflected in additional embodiments and the invention may be practiced without some of the details in the following description.
The various embodiments including the example embodiments will now be described more fully with reference to the accompanying drawings, in which the various embodiments of the invention are shown. The invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the sizes of components may be exaggerated for clarity.
It will be understood that when an element or layer is referred to as being “on,” “connected to,” or “coupled to” another element or layer, it can be directly on, connected to, or coupled to the other element or layer or intervening elements or layers that may be present. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Spatially relative terms, such as “arm,” “frame,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the structure in use or operation in addition to the orientation depicted in the figures.
Embodiments described herein will refer to plan views and/or cross-sectional views by way of ideal schematic views. Accordingly, the views may be modified depending on simplistic assembling or manufacturing technologies and/or tolerances. Therefore, example embodiments are not limited to those shown in the views but include modifications in configurations formed on basis of assembling process. Therefore, regions exemplified in the figures have schematic properties and shapes of regions shown in the figures exemplify specific shapes or regions of elements, and do not limit the various embodiments including the example embodiments.
The subject matter of example embodiments, as disclosed herein, is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different features or combinations of features similar to the ones described in this document, in conjunction with other technologies. Generally, the various embodiments including the example embodiments relate to an irrigation control system and method for monitoring and controlling pressure inside a patient’s body.
Referring to Fig. 1a a block diagram of an irrigation control system 100 for monitoring and controlling pressure inside a patient’s body is provided in accordance with an embodiment of the present invention. The system (100) includes a user interface (102) configured to operate a plurality of operations of the system, at least one pressure sensor (104) configured to sense a pressure inside the patient body cavity and alerting the system (100) for closing an inlet valve (106), at least one flow sensor (108) configured to sense flow of fluid to the patient’s body, a suction port (110) for controlling suction of the fluid, and a controller (112) encoded with instructions enabling the controller to function as a simulator configured to emulate a closed working enclosure by closing an outlet valve of the system using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and flow sensor to determine appropriate functioning of the device before every single application, wherein the at least one pressure sensor and flow sensor are operatively coupled to the controller for enabling the system to self-approve use for surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the system to ascertain appropriate functioning. The system components are connected via tube (114). The pressure inlet (106) communicates with the control unit (102) and the pressure sensor (104). Fig. 1b illustrates a block diagram of the irrigation control system 100 having a bubble detector (160) that communicates with the control unit (102) to determine and indicate presence of bubble.
Referring to Fig. 1c, front view (100a) of the user interface (102) of the system (100) is shown in accordance with an embodiment of the present invention. The user interface (102) includes a pressure setting window (116) displaying pressure value (116a), a pressure decrement switch (118), a pressure increment switch (120), intra-cavity pressure set window (122), a flow rate set window (124) displaying flow rate value (124a), a flow rate decrement switch (126), a flow rate increment switch (128), a flush switch (130) to remove tube air or saline, a suction enabling switch (132) and an irrigation start or stop switch (134).
In an embodiment, the intra cavity pressure set window (122) uses the pressure decrement switch (118) or pressure increment switch (120) to set a desired pressure where the self-test operation is performed below 200mmHg and a pressure above 200mmHg is used with extreme care and in exceptional situations.
In an embodiment, the intra cavity pressure set window (122) displays an intra cavity pressure with +/- 10 % range of set value. As actual pressure reaches the set pressure, irrigation automatically pauses and restarts if pressure goes down.
In an embodiment, the flow rate set window (124) displays a maximum ?ow rate during procedure wherein the flow rate decrement switch (126) or the flow rate increment switch (128) set a desired maximum ?ow rate with an ideal setting around 400 ml/min.
In an embodiment, the suction switch enables suction control of fluid by operating a foot switch (136) to start & stop suction wherein when foot switch is pressed irrigation stops automatically.
In an embodiment, the controller (112) is configured to stop the system (100) when actual pressure inside the patient body is equal to a set pressure on the interface (102).
Referring to Fig. 1d, a perspective view of system (100b) with interconnections is shown in accordance with an embodiment of the present invention. The system (300) includes a suction Jar instrument (138) is connected to the suction port (110) via jar suction connector (146) and the instrument (138) is connected to hand instrument (148) via Jar hand instrument connector (150).
In an embodiment, a control channel (140) on a tube connects the system with a liquid saline source (142) and a saline outlet (144).
In an embodiment, a cavity pressure sensor port (152) is connected to the system (100) via connector (154).
Referring to Fig. 2, a flowchart (200) depicting an irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device comprising at least one pressure sensor, at least one flow sensor, a user interface, a suction port and a controller is provided. The method includes the steps of S202 testing functioning of the pump device by emulating a closed working enclosure by closing an outlet valve of the pump using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and the flow sensor to determine appropriate functioning of the pump before every single application. In S204 in response to sensing a pressure inside patient body cavity, alerting the device for closing an inlet valve, wherein the device self-approves use for a surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the device to ascertain appropriate functioning of the device.
Referring to Fig. 3, a detailed example flowchart (300) depicting the irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device comprising at least one pressure sensor, at least one flow sensor, a user interface, a suction port and a controller is provided. The method includes the step of S302 checking for initiating self-test. In S304, if Yes, then starting the self-test else in S306 aborting the test to start operational window in S308. In S310 auto setting input pressure to a pressure point 1 such as 100mmHg. In S312 running motor of the device and in S314 display message to close tip. In S316 if abort the start operation window of S308 else, check if actual pressure > a pressure point 1 in S318. If the actual pressure is greater then, in S320 auto set pressure to a pressure point 2 such as 200 mmHg, else display message to close tip of S314. In S322 run the motor and in S324 display message to close the tip. In S326 check if abort, if yes then start operation window of S308 else in S328 check if actual pressure > the pressure point 2, if yes in S330 auto set input pressure to a pressure point 3 such as 300mmHg else, display message to close the tip. In S332 run motor and in S334 display message to close the tip. In S338 check if abort, if yes then in S340 start operation window, else in S342 check if actual pressure is greater than the pressure point 3. If the pressure is greater then, in S344 auto set pressure to a pressure point 4 such as 400mmHg, and run motor in S346. In S348 display message to close tip. In S350 check if abort, if yes then start operation window of S340 else in S352 check if actual pressure > the pressure point 2, if yes start operational window of S340 else, display message to close the tip.
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 of the claims.
CLAIMS:1. An irrigation control system for monitoring and controlling pressure inside a patient’s body, the system comprising:
a user interface configured to operate a plurality of operations of the system;
at least one pressure sensor configured to sense a pressure inside the patient body cavity and alerting the system for closing an inlet valve;
at least one flow sensor configured to sense flow of fluid to the patient’s body;
a suction port for controlling suction of the fluid, and
a controller encoded with instructions enabling the controller to function as a simulator configured to emulate a closed working enclosure by closing an outlet valve of the system using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and flow sensor to determine appropriate functioning of the device before every single application,
wherein the at least one pressure sensor and flow sensor are operatively coupled to the controller for enabling the system to self-approve use for surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the system to ascertain appropriate functioning.
2. The system as claimed in claim 1 wherein the user interface further comprises:
a pressure setting window, a pressure decrement switch, a pressure increment switch, intra-cavity pressure set window, a flow rate decrement switch, a flow rate increment switch, a flush switch to remove tube air or saline, a suction enabling switch and an irrigation start or stop switch.
3. The system as claimed in claim 2 wherein the intra cavity pressure set window uses the pressure decrement switch or pressure increment switch to set a desired pressure wherein the self-test operation is performed below a set pressure point and a pressure above the set pressure point is used with extreme care and in exceptional situations.
4. The system as claimed in claim 2 wherein the intra cavity pressure set window displays a intra cavity pressure wherein as actual pressure reaches the set pressure, irrigation automatically pauses and restarts if pressure goes down.
5. The system as claimed in claim 2 wherein a flow rate set window displays a maximum ?ow rate during procedure wherein the flow rate decrement switch or the flow rate increment switch set a desired maximum ?ow rate.
6. The system as claimed in claim 2 wherein the suction switch enables suction control of fluid by operating a foot switch to start & stop suction wherein when foot switch is pressed irrigation stops automatically.
7. The system as claimed in claim 2 wherein the controller is configured to stop the system when actual pressure inside the patient body is equal to a set pressure on the interface.
8. The system as claimed in claim 2 further comprising suction Jar instrument connected to the suction port via tubes.
9. The system as claimed in claim 2 further comprising control channel on a tube connecting the system with a liquid saline source.
10. An irrigation control method for monitoring and controlling pressure inside a patient’s body using a pump device comprising at least one pressure sensor, at least one flow sensor, a user interface, a suction port and a controller, the method comprising:
testing functioning of the pump device by emulating a closed working enclosure by closing an outlet valve of the pump using a non-contaminating means wherein the device self-tests operation of the at least one pressure sensor and the flow sensor to determine appropriate functioning of the pump before every single application; and
in response to sensing a pressure inside patient body cavity, alerting the device for closing an inlet valve,
wherein the device self-approves use for a surgical application in response to appropriate detection of a pressure cut-off value and stoppage of the device to ascertain appropriate functioning of the device.
11. The method as claimed in claim 10 comprising the step of setting a desired pressure at an intra-cavity pressure set window of a user interface of the device wherein the wherein the self-test operation is performed below a set pressure point and a pressure above the set pressure point is used with extreme care and in exceptional situations.
12. The method as claimed in claim 11 wherein the intra cavity pressure set window displays a intra cavity pressure wherein as actual pressure reaches the desired set pressure, irrigation automatically pauses and restarts if pressure goes down.
13. The method as claimed in claim 10 further comprising the step of setting a desired maximum flow rate.
14. The method as claimed in claim 10 further comprises suction control of fluid by operating a foot switch to start & stop suction wherein when foot switch is pressed irrigation stops automatically.
15. The method as claimed in claim 11 wherein a controller is configured to stop the device when actual pressure inside the patient body is equal to the set pressure on the interface.
| # | Name | Date |
|---|---|---|
| 1 | 201911033292-PROVISIONAL SPECIFICATION [19-08-2019(online)].pdf | 2019-08-19 |
| 2 | 201911033292-FORM FOR STARTUP [19-08-2019(online)].pdf | 2019-08-19 |
| 3 | 201911033292-FORM FOR SMALL ENTITY(FORM-28) [19-08-2019(online)].pdf | 2019-08-19 |
| 4 | 201911033292-FORM 1 [19-08-2019(online)].pdf | 2019-08-19 |
| 5 | 201911033292-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [19-08-2019(online)].pdf | 2019-08-19 |
| 6 | 201911033292-EVIDENCE FOR REGISTRATION UNDER SSI [19-08-2019(online)].pdf | 2019-08-19 |
| 7 | 201911033292-DRAWINGS [19-08-2019(online)].pdf | 2019-08-19 |
| 8 | abstract.jpg | 2019-09-06 |
| 9 | 201911033292-Proof of Right (MANDATORY) [06-09-2019(online)].pdf | 2019-09-06 |
| 10 | 201911033292-FORM-26 [06-09-2019(online)].pdf | 2019-09-06 |
| 11 | 201911033292-Power of Attorney-090919.pdf | 2019-09-13 |
| 12 | 201911033292-OTHERS-090919.pdf | 2019-09-13 |
| 13 | 201911033292-Correspondence-090919.pdf | 2019-09-13 |
| 14 | 201911033292-DRAWING [19-08-2020(online)].pdf | 2020-08-19 |
| 15 | 201911033292-COMPLETE SPECIFICATION [19-08-2020(online)].pdf | 2020-08-19 |
| 16 | 201911033292-ENDORSEMENT BY INVENTORS [24-08-2020(online)].pdf | 2020-08-24 |
| 17 | 201911033292-STARTUP [18-08-2023(online)].pdf | 2023-08-18 |
| 18 | 201911033292-FORM28 [18-08-2023(online)].pdf | 2023-08-18 |
| 19 | 201911033292-FORM 18A [18-08-2023(online)].pdf | 2023-08-18 |
| 20 | 201911033292-FER.pdf | 2023-09-13 |
| 21 | 201911033292-OTHERS [13-03-2024(online)].pdf | 2024-03-13 |
| 22 | 201911033292-FER_SER_REPLY [13-03-2024(online)].pdf | 2024-03-13 |
| 23 | 201911033292-CLAIMS [13-03-2024(online)].pdf | 2024-03-13 |
| 24 | 201911033292-ABSTRACT [13-03-2024(online)].pdf | 2024-03-13 |
| 25 | 201911033292-US(14)-HearingNotice-(HearingDate-21-06-2024).pdf | 2024-05-21 |
| 26 | 201911033292-FORM-26 [17-06-2024(online)].pdf | 2024-06-17 |
| 27 | 201911033292-Correspondence to notify the Controller [17-06-2024(online)].pdf | 2024-06-17 |
| 28 | 201911033292-Written submissions and relevant documents [05-07-2024(online)].pdf | 2024-07-05 |
| 29 | 201911033292-FORM FOR STARTUP [05-07-2024(online)].pdf | 2024-07-05 |
| 30 | 201911033292-EVIDENCE FOR REGISTRATION UNDER SSI [05-07-2024(online)].pdf | 2024-07-05 |
| 31 | 201911033292-PatentCertificate09-08-2024.pdf | 2024-08-09 |
| 32 | 201911033292-IntimationOfGrant09-08-2024.pdf | 2024-08-09 |
| 1 | searchE_13-09-2023.pdf |