Balloon endoscope reprocessing system and method
11160445 · 2021-11-02
Assignee
Inventors
Cpc classification
A61B2090/701
HUMAN NECESSITIES
B08B3/10
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61B1/00
HUMAN NECESSITIES
B08B3/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
A reprocessing system for balloon endoscopes including an endoscope reprocessing system including cleaning functionality and disinfection functionality, and a leak testing device including inflation and deflation functionality, the inflation and deflation functionality being operative to selectably inflate and deflate a balloon of a balloon endoscope.
Claims
1. A reprocessing system for balloon endoscopes comprising: an endoscope reprocessing system including cleaning functionality, and disinfection functionality; and a leak testing device including inflation and deflation functionality, said inflation and deflation functionality being operative to selectably inflate and deflate a balloon of a balloon endoscope, wherein said reprocessing system provides at least the following operational stages: a first balloon-deflated stage in which the balloon of the balloon endoscope is in a first balloon-deflated configuration, a first reprocessing stage when the balloon of the balloon endoscope is in the first balloon-deflated configuration, a balloon-inflated stage in which the balloon of the balloon endoscope is in a balloon-inflated configuration, a second balloon-deflated stage following the balloon-inflated stage in which the balloon of the balloon endoscope is in a second balloon-deflated configuration, and a second reprocessing stage when the balloon of the balloon endoscope is in the second balloon-deflated configuration.
2. A reprocessing system for balloon endoscopes according to claim 1 and wherein: in the first balloon-deflated configuration a first set of regions of an outer surface of the balloon are exposed to reprocessing; in the second balloon-deflated configuration a second set of regions of the outer surface of the balloon are exposed to reprocessing; and the first set of regions and the second set of regions are at least partially different.
3. A reprocessing system for balloon endoscopes according to claim 1 and wherein operation of the endoscope reprocessing system in the first reprocessing stage is identical to operation of the endoscope reprocessing system in the second reprocessing stage.
4. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to inflate and deflate the balloon following removal of the balloon endoscope from the reprocessing system after the first reprocessing stage and prior to placement of the balloon endoscope in the reprocessing system for the second reprocessing stage.
5. A reprocessing system for balloon endoscopes according to claim 1 and wherein the reprocessing stages are only operative when the balloon is in a deflated configuration.
6. A reprocessing system for balloon endoscopes according to claim 1 and wherein the reprocessing stages comprise at least one of cleaning and disinfection of the balloon endoscope.
7. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide negative pressure below −50 millibar in the balloon.
8. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide negative pressure below −80 millibar in the balloon.
9. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide negative pressure below −100 millibar in the balloon.
10. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide positive pressure in a range of 10 millibar to 120 millibar in the balloon.
11. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide positive pressure in a range of 15 millibar to 70 millibar in the balloon.
12. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide positive pressure in a range of 20 millibar to 60 millibar in the balloon.
13. A reprocessing system for balloon endoscopes according to claim 1 and wherein the leak testing device is operative to provide positive pressure below 80 millibar in the balloon.
Description
BRIEF DESCRIPTION OF PREFERRED EMBODIMENTS
(1) The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
(2)
(3)
(4)
(5)
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(6) Reference is now made to
(7) In accordance with an embodiment of the present invention, a conventional endoscope reprocessing system is modified to enable the reprocessing system to carry out the steps of the embodiments of the methods illustrated in
(8) The modified endoscope reprocessing system, here generally designated by reference numeral 100, preferably includes generally all of the conventional reprocessing functionality 102 of the conventional endoscope reprocessing system, including cleaning functionality 104 and disinfection functionality 106, as well as an added or modified leak testing subsystem 110. The leak testing subsystem 110 is shown in
(9) It is a particular feature of the embodiments of the present invention shown in
(10)
(11) From a consideration of
(12) Comparing the embodiments of
(13) It is appreciated that reprocessing the balloon endoscope only when it is in a balloon-deflated configuration has the advantage of preventing mechanical damage to balloon 116 during reprocessing, such as rupture by revolving jets of the reprocessing system 100, when reprocessing system 100 employs revolving jets, over-inflation of balloon 116 due to air expansion at elevated reprocessing temperatures which may result in irreversible distortion of balloon 116, and other adverse consequences.
(14) The reprocessing method of this embodiment of the present invention may thus be summarized as including at least the following steps: introducing a balloon endoscope to be reprocessed into an endoscope reprocessing system; performing reprocessing on the balloon endoscope to be reprocessed while a balloon of the balloon endoscope is deflated; thereafter inflating the balloon of the balloon endoscope; thereafter deflating the balloon of the balloon endoscope; and thereafter performing further reprocessing on the balloon endoscope to be reprocessed while the balloon of the balloon endoscope is deflated.
(15) It is appreciated that additional stages of balloon inflation and subsequent deflation followed by additional reprocessing stages when the balloon 116 is in a deflated configuration may be provided as appropriate to achieve a desired quality of reprocessing.
(16) In contrast to the above-described embodiment shown in
(17) With reference to
(18) The reprocessing method of the embodiment of the present invention illustrated in
(19) It is appreciated that additional stages of balloon inflation and subsequent deflation followed by additional reprocessing stages may be provided as appropriate to achieve a desired quality of reprocessing.
(20) It is appreciated that inflating the balloon 116 while the balloon endoscope is being reprocessed has the advantages of saving time and simplifying the reprocessing operation, however, it is appreciated that the reprocessing performed while balloon 116 is inflated is preferably a limited reprocessing and is preferably performed for a short period of time during which the cleaning functionality 104, the disinfection functionality 106, and the leak testing subsystem 110 are operated in a limited reprocessing mode to prevent mechanical damage to the inflated balloon 116 during reprocessing.
(21) In particular, the operation of revolving jets or other moving parts in the reprocessing chamber 118, to the extent such are employed by the cleaning functionality 104 and/or disinfection functionality 106, is preferably paused when the balloon 116 is being inflated, to prevent rupture of the inflated balloon 116.
(22) Furthermore, heating of cleaning or disinfection solutions by the cleaning functionality 104 and/or disinfection functionality 106, is preferably paused when the balloon 116 is being inflated, to prevent over-inflation of balloon 116 due to air expansion at elevated reprocessing temperatures which may result in irreversible distortion of balloon 116. Additionally or alternatively, pressure in balloon 116 is continuously controlled and monitored by leak testing subsystem 110 during inflation of balloon 116, to prevent over-inflation and resulting irreversible distortion of the inflated balloon 116.
(23) It is appreciated that the balloon-deflated configuration of balloon endoscope 112 is achieved by provision to balloon 116 of negative pressure, namely pressure lower than the ambient pressure (which is typically atmospheric pressure), by leak testing subsystem 110. Preferably, the negative pressure in balloon 116 is below −50 millibar (meaning that the atmospheric pressure is higher than the absolute pressure in the balloon 116 by more than 50 millibar). More preferably, the negative pressure in balloon 116 is below −80 millibar. Yet more preferably, the negative pressure in balloon 116 is below −100 millibar.
(24) It is further appreciated that the balloon-inflated configuration of balloon endoscope 112 is achieved by provision to balloon 116 of positive pressure, namely pressure higher than the ambient pressure (which is typically atmospheric pressure), by leak testing subsystem 110. Preferably, the positive pressure in balloon 116 is in the range of 10 millibar to 120 millibar (meaning that the absolute pressure in balloon 116 is higher than the atmospheric pressure by 10-120 millibar). More preferably, the positive pressure in balloon 116 is in the range of 15 millibar to 70 millibar. Yet more preferably, the positive pressure in balloon 116 is in the range of 20 millibar to 60 millibar. In accordance with another embodiment of the invention, the positive pressure in the inflated balloon 116 is below 80 millibar.
(25) It is appreciated that the modified conventional reprocessing system 100 includes one or more of the following modifications of the conventional reprocessing system, as required for enabling it to perform the reprocessing method of the invention as described with respect to the embodiments of
(26) It is a particular feature of the invention, as described with respect to the embodiments of
(27) Reference is now made to
(28) It is a particular feature of this embodiment of the present invention that the reprocessing method is carried out by a conventional endoscope reprocessing system and a separate leak testing device, wherein at least one and preferably both, inflating and deflating the balloon is carried out by a separate leak testing device.
(29) As seen in
(30) Preferably, the power cord 203 of conventional endoscope reprocessing system 200 is connected to mains electrical power via a switch 204, which preferably has three operation buttons, a START button 206, a PAUSE button 207, and a CONTINUE button 208. START button 206 is effective, when pressed, to provide electrical power to reprocessing system 200 and to terminate the supply of electrical power to reprocessing system 200 when subsequently pressed again. PAUSE button 207 is operative, when pressed, to interrupt the supply of electrical power to reprocessing system 200 without causing electrical spikes that may damage reprocessing system 200 and CONTINUE button 208 is operative when pressed to release PAUSE button 207 and resume the supply of electrical power to reprocessing system 200.
(31) It is appreciated that some or all of the functions of buttons 206, 207 and 208 may be available on the user interface of conventional endoscope reprocessing system 200, and may be operated therethrough instead of by pressing the buttons of switch 204. It is appreciated that if the functions of all three buttons of the switch 204, START, PAUSE and CONTINUE, can be performed by the existing functionalities and user interface of the conventional reprocessing system 200, the switch 204 may be obviated and the power cord 203 of reprocessing system 200 may be connected directly to a mains electrical power outlet.
(32) As seen in
(33) It is a particular feature of this embodiment of the present invention that the conventional reprocessing system 200 and the separate conventional leak testing device 202 are preferably operated to have at least the following six sequential operational stages, which are illustrated in
(34) From a consideration of
(35) It is thus appreciated that in accordance with a preferred embodiment of the invention the balloon endoscope 212 is only reprocessed when the balloon 216 is deflated and the balloon 216 is inflated and subsequently deflated between two reprocessing stages, which stages may or may not be identical. This inflation and deflation has a distinct advantage in that it exposes different surfaces of the deflated balloon 216 and thus produces enhanced cleaning of the balloon 216 in reprocessing.
(36) The reprocessing method of this embodiment of the present invention may thus be summarized as including at least the following steps: introducing a balloon endoscope 212 to be reprocessed into a conventional endoscope reprocessing system 200, as seen in
(37) It is appreciated that additional stages of balloon inflation and subsequent deflation followed by additional reprocessing stages may be provided as appropriate to achieve a desired quality of reprocessing.
(38) It is appreciated that balloon inflation and deflation may be performed by any suitable device other than the conventional leak testing device 202, for example by using a balloon inflation/deflation device, such as a NaviAid SPARK2C inflation system, commercially available from Smart Medical Systems, of 10 Hayetsira street, Raanana, Israel.
(39) It is appreciated that the balloon-deflated configuration of balloon endoscope 212 is achieved by provision to balloon 216 of negative pressure, namely pressure lower than the ambient pressure (which is typically atmospheric pressure), preferably by the leak testing device 202.
(40) Preferably, the negative pressure in balloon 216 is below −50 millibar (meaning that the atmospheric pressure is higher than the absolute pressure in the balloon 216 by more than 50 millibar). More preferably, the negative pressure in balloon 216 is below −80 millibar. Yet more preferably, the negative pressure in balloon 216 is below −100 millibar.
(41) It is further appreciated that the balloon-inflated configuration of balloon endoscope 212 is achieved by provision to balloon 216 of positive pressure, namely pressure higher than the ambient pressure (which is typically atmospheric pressure), preferably by the leak testing device 202.
(42) Preferably, the positive pressure in balloon 216 is in the range of 10 millibar to 120 millibar (meaning that the absolute pressure in balloon 216 is higher than the atmospheric pressure by 10-120 millibar). More preferably, the positive pressure in balloon 216 is in the range of 15 millibar to 70 millibar. Yet more preferably, the positive pressure in balloon 216 is in the range of 20 millibar to 60 millibar. In accordance with another embodiment of the invention, the positive pressure in the inflated balloon 216 is below 80 millibar.
(43) It is a particular feature of the embodiment of
(44) It is appreciated that performance of all or substantially all of the reprocessing operation while the balloon endoscope 212 is in a balloon-deflated configuration as described with respect to the embodiment of
(45) It is a particular purpose of the present invention, as seen in all embodiments described hereinabove, to provide a reprocessing method for balloon endoscopes that includes reprocessing in two balloon-deflated configurations of the balloon endoscope being reprocessed, wherein in the first balloon-deflated configuration, a first set of regions of an outer surface of a balloon of the balloon endoscope are exposed to reprocessing, in said second balloon-deflated configuration, a second set of regions of said outer surface of said balloon of said balloon endoscope are exposed to reprocessing, and wherein the first set of regions and the second set of regions are at least partially different. It is appreciated that reprocessing of the balloon endoscope preferably includes at least one of cleaning and disinfection of the balloon endoscope.
(46) It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of features described and illustrated as well as modifications and variations thereof which are not in the prior art.