Balloon-equipped endoscopic devices and methods thereof
11247029 · 2022-02-15
Assignee
Inventors
Cpc classification
A61B1/31
HUMAN NECESSITIES
A61M2025/1086
HUMAN NECESSITIES
A61M25/10184
HUMAN NECESSITIES
A61M25/10181
HUMAN NECESSITIES
International classification
A61B1/31
HUMAN NECESSITIES
A61B1/273
HUMAN NECESSITIES
A61B1/00
HUMAN NECESSITIES
Abstract
An endoscopy system including a balloon-equipped endoscope including a balloon which is configured for slidable frictional engagement with an interior wall of a body passageway and axial stretching of the interior wall when inflated to a slidable frictional engagement pressure and displaced axially along the body passageway and a balloon inflation subsystem operative to selectably inflate the balloon to the slidable frictional engagement pressure.
Claims
1. A method for performing an endoscopy, comprising: advancing an endoscope through an intestine, the endoscope comprising a viewing portion positioned at a distal end and a balloon mounted at the distal end of the endoscope, the balloon mounted entirely and completely rearwardly of the viewing portion and configured for generally circumferential slidable frictional engagement with an interior wall of the intestine, wherein the balloon extends radially outward from the endoscope; automatically inflating the balloon to a predetermined anchoring pressure range via a controller upon a user selection of the predetermined anchoring pressure range; automatically deflating or inflating the balloon to a pressure value within a predetermined slidable frictional engagement pressure range via the controller upon a user selection of the predetermined slidable frictional engagement pressure range, the predetermined slidable frictional engagement pressure range being lower than a pressure value within an anchoring pressure range of the balloon; and retracting the endoscope through the intestine while maintaining the balloon pressure within the predetermined slidable frictional engagement pressure range such that during retraction of the endoscope through the intestine natural folds within the intestine are unfolded by engagement of the balloon with the interior wall of the intestine such that features of interest within the intestine become visible to the viewing portion.
2. The method of claim 1, wherein the balloon is configured such that the balloon is not visible to the viewing portion during retraction of the endoscope.
3. The method of claim 1, wherein during retraction of the endoscope, the balloon is configured to enable systematic visual inspection of the intestine.
4. The method of claim 1, wherein the slidable frictional engagement pressure is not higher than 35 millibar.
5. The method of claim 1, wherein the features of interest comprise polyps.
6. The method of claim 1, wherein circumferential engagement of the balloon with the interior wall of the intestine produces axial stretching of the interior wall of the intestine.
7. The method of claim 6, wherein axial stretching of the interior wall comprises axial stretching of the interior wall by at least 35%.
8. The method of claim 7, wherein axial stretching of the interior wall comprises axial stretching of the interior wall by at least 60%.
9. The method of claim 1, wherein the balloon comprises silicone.
10. The method of claim 1, wherein a ratio between a pressure value within the anchoring pressure range and a pressure value within the predetermined slidable frictional engagement pressure range is from 1.3-7.
11. A method for performing an endoscopy comprising: advancing an endoscope through an intestine, the endoscope comprising a viewing portion positioned at a distal end and a balloon mounted to the endoscope entirely and completely rearwardly of the viewing portion such that the balloon is not visible during retraction of the endoscope, the balloon configured for slidable frictional engagement with an interior wall of the intestine, wherein the balloon extends radially outward from the endoscope; automatically inflating the balloon to a predetermined anchoring pressure range via a controller upon a user selection of the predetermined anchoring pressure range; automatically deflating or inflating the balloon to a pressure value within a predetermined slidable frictional engagement pressure range via the controller upon a user selection of the predetermined slidable frictional engagement pressure range, the predetermined slidable frictional engagement pressure range being lower than a pressure value within an anchoring pressure range of the balloon; and retracting the endoscope through the intestine while maintaining the balloon pressure within the predetermined slidable frictional engagement pressure range such that during retraction of the endoscope through the intestine, natural folds within the intestine are unfolded by engagement of the balloon with the interior wall of the intestine such that features of interest within the intestine become visible to the viewing portion.
12. The method of claim 11, wherein the slidable frictional engagement pressure is not higher than 35 millibar.
13. The method of claim 11, wherein engagement of the balloon with the interior wall of the intestine produces axial stretching of the interior wall of the colon.
14. The method of claim 13, wherein axial stretching of the interior wall comprises axial stretching of the interior wall by at least 35%.
15. The method of claim 14, wherein axial stretching of the interior wall comprises axial stretching of the interior wall by at least 60%.
16. The method of claim 11, wherein the features of interest comprise polyps.
17. The method of claim 11, wherein the balloon comprises silicone.
18. The method of claim 11, wherein a ratio between a pressure value within the anchoring pressure range and a pressure value within the predetermined slidable frictional engagement pressure range is from 1.3-7.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(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)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(16) Reference is now made to
(17) The terms “endoscope” and “endoscopy” are used throughout in a manner somewhat broader than their customary meaning and refer to apparatus and methods which operate within body cavities, passageways and the like, such as, for example, the small intestine and the large intestine. Although these terms normally refer to visual inspection, as used herein they are not limited to applications which employ visual inspection and refer as well to apparatus, systems and methods which need not necessarily involve visual inspection.
(18) The term “forward” refers to the remote end of an endoscope, accessory or tool furthest from the operator or to a direction facing such remote end.
(19) The term “rearward” refers to the end portion of an endoscope, accessory or tool closest to the operator, typically outside an organ or body portion of interest or to a direction facing such end portion.
(20) Pressure is indicated in millibars above ambient (atmospheric) pressure.
(21)
(22) Other than as specifically described hereinbelow, the endoscope 100 may be a conventional endoscope, such as an EC-3470LK video colonoscope or a VSB-3430K video enteroscope, the endoscope system 102 may be a conventional endoscope system, such as a console including a EPK-1000 video processor, and the monitor 104 may be a conventional monitor, such as a SONY LMD-2140MD medical grade flat panel LCD monitor, all commercially available from Pentax Europe GmbH, 104 Julius Vosseler St., 22527 Hamburg, Germany.
(23) As distinct from a conventional endoscope, and as described in Published PCT Application WO 2011/111040, published on Sep. 15, 2011, the disclosure of which is hereby incorporated by reference, the endoscope 100 has an outer sheath 106 which is preferably provided with at least one balloon inflation/deflation aperture 108, with which is associated a fluid flow discriminator such as a filter 109, preferably a gas permeable, liquid impermeable filter. The aperture 108 preferably communicates with the interior of an inflatable/deflatable balloon 110, sealably mounted on outer sheath 106, and with an interior volume 112 of the endoscope 100, which in conventional endoscopes is sealed from the exterior other than via a leak test port 114 at a rearward portion of the endoscope. In accordance with a preferred embodiment of the present invention, interior volume 112 generally fills the interior of the endoscope 100 which is not occupied by conduits and other elements extending therethrough.
(24) It is appreciated that a gas communication path extends between the leak test port 114 via the interior volume 112 of the endoscope, filter 109 and aperture 108 to a balloon volume 116 at the interior of inflatable/deflatable balloon 110. It is a particular feature of this embodiment of the present invention that the interior volume 112 provides a gas reservoir, enabling quick pressurization and depressurization of balloon 110 and a directly coupled pressure buffer operative to reduce the amplitude of pressure changes inside the balloon 110 resulting from corresponding changes in balloon volume 116. It is appreciated that having a gas reservoir, such as interior volume 112, in inflation propinquity to balloon 110 as described hereinabove, also provides inflation pressure buffering for balloon 110 and enables enhanced stability and accuracy to be achieved in the pressurization of the inflated balloon volume 116.
(25) Preferably for certain applications, the balloon 110 is designed to have an inflated balloon volume 116 in the range of approximately 60-80 cc, when the balloon 110 is inflated to a pressure of 10 millibar, and the interior volume 112 of the endo scope has a volume in the range of approximately 450-550 cc.
(26) Preferably for other applications, the balloon 110 is designed to have an inflated balloon volume 116 in the range of approximately 130-180 cc, when the balloon 110 is inflated to a pressure of 10 millibar, and the interior volume 112 of the endoscope has a volume in the range of approximately 700-900 cc.
(27) Preferably for still other applications, the balloon 110 is designed to have an inflated balloon volume 116 in the range of approximately 100-150 cc, when the balloon 110 is inflated to a pressure of 10 millibar, and the interior volume 112 of the endoscope has a volume in the range of approximately 500-900 cc.
(28) Balloon 110 preferably is configured to have an inflated balloon volume 116 which is less than half of interior volume 112 of the endoscope. More preferably, balloon 110 preferably is configured to have an inflated balloon volume 116 which is less than one third of interior volume 112 of the endoscope. Most preferably, balloon 110 preferably is configured to have an inflated balloon volume 116 which is less than one fifth of interior volume 112 of the endoscope.
(29) It is a particular feature of an embodiment of the present invention, that inflatable balloon 110 is directly coupled to a gas reservoir, such as interior volume 112, having a volume typically 3-7 times higher than the inflated balloon volume 116.
(30) Alternatively, depending on the configuration of the endoscope, the leak test port 114 need not be located as illustrated in
(31) Alternatively, as not shown, the interior of balloon 110 may communicate with a fluid flow passageway other than interior volume 112, such as, for example, a fluid conduit or other conduit, such as a conventional dedicated balloon inflation/deflation channel and aperture 108 and filter 109 may be obviated.
(32) An instrument channel port 118 preferably communicates with an instrument channel 120, extending throughout the length of endoscope 100.
(33) Inflatable/deflatable balloon 110 preferably is inflated and/or deflated via the interior volume 112 of the balloon endoscope 100 by a balloon inflation/deflation system 130, which constitutes a balloon inflation and/or deflation subsystem of the endoscopy system of
(34) Reference is now made additionally to
(35) As seen in
(36) It is further appreciated that notwithstanding the fact that various conduits may extend through the interior volume 106, their presence does not result in fluid communication between the interior volume 112 and the interior of any conduit extending therethrough.
(37) Forwardly of tubular sealing sheath 132, outer sheath 106 includes a tubular sealing bending rubber sheath 144, which also seals the interior volume 112 from the exterior of endoscope 100. Bending rubber sheath 144 may be an off-the-shelf product, such as a silicone bending rubber sheath part number SPRBSS11, PVC bending rubber sheath part number SPRBSP11, or a Viton bending rubber sheath part number SPRBSV11, all commercially available from Endoscope Repair Inc. of 5201 Blue Lagoon Drive, No. 815 Miami, Fla. 33126 USA. Preferably, aperture 108 is formed in sheath 144 and overlies filter 109. It is appreciated that plural apertures 108, having associated therewith plural filters 109, may be provided for gas communication between the interior of inflatable/deflatable balloon 110 and the interior volume 112 of endoscope 100. It is also appreciated that filter 109 may be obviated.
(38) Bending rubber sheath 144 overlies a selectably bendable reinforcement mesh 145, which is selectably bendable in response to operator manipulation of steering knobs (not shown) at a rearward portion of endoscope 100, and protects the forward selectably bendable portion of endoscope 100 against collapse during bending thereof. Instrument channel 120 and optical bundle 136 and optionally other elements extend interiorly of selectably bendable reinforcement mesh 145, through the interior volume 112 of the endoscope.
(39) In accordance with a preferred embodiment of the present invention, the forward end of reinforcement mesh 134 and the rearward end of selectably bendable reinforcement mesh 145 are joined together by a rigid collar element 150, preferably formed of metal or rigid plastic, which underlies a forward end 151 of tubular sealing sheath 132, which is butted against a rearward end 152 of sheath 144. A rearward end 153 of inflatable balloon 110 is retained over rearward end 152 of sheath 144 preferably by a wire 156 wound thereabout. The rearward end 153 of balloon 110 is preferably additionally sealed to respective ends 151 and 152 of sheaths 132 and 144 by an adhesive 158, such as a medical grade epoxy M31-CL, commercially available from Henkel Corporation, One Henkel Way, Rocky Hill, Conn. 06067, USA.
(40) Further in accordance with a preferred embodiment of the present invention, endoscope 100 includes, at the forward end thereof, a rigid tip portion 170 which is connected to a forward end of selectably bendable reinforcement mesh 145. Preferably, rigid tip portion 170 is formed of metal or rigid plastic, and a rearward portion 172 thereof underlies a forward end 174 of sheath 144. A forward end 176 of inflatable balloon 110 is retained over forward end 174 of sheath 144 preferably by a wire 178 wound thereabout. The forward end 176 of balloon 110 is preferably additionally sealed to rigid tip portion 170 by an adhesive 180, such as a medical grade epoxy M31-CL, commercially available from Henkel Corporation.
(41) Filter 109 is preferably mounted onto an inner surface of sheath 144 underlying aperture 108 by any suitable technique, such as by the use of adhesive, for example a Polychloroprene based Contact Cement commercially available from Elmer's Products Inc. of One Easton Oval, Columbus, Ohio 43219, USA. It is appreciated that a gas communication path extends between leak test port 114 via the interior volume 112, filter 109 and aperture 108 to balloon volume 116 at the interior of inflatable/deflatable balloon 110.
(42) It is a particular feature of an embodiment of the present invention that the length of balloon 110 is approximately similar to the length of the bending rubber sheath 144 and aligned therewith, as shown in
(43) It is also a particular feature of an embodiment of the present invention that the rearward end 153 of balloon 110 is mounted over the rearward end 152 of sheath 144. It is additionally a particular feature of an embodiment of the present invention that the forward end 176 of balloon 110 is mounted over the forward end 174 of sheath 144.
(44) It is a further particular feature of a preferred embodiment of the present invention that rearward end 153 of balloon 110 is mounted over rigid collar element 150 and over rearward end 152 of sheath 144 by wound wire 156 and adhesive 158 and that forward end 176 of balloon 110 is mounted over rearward portion 172 of rigid tip portion 170 and over forward end 174 of sheath 144 by wound wire 178 and adhesive 180.
(45) The aforesaid arrangement has the advantage of providing secure and stable mounting of balloon 110 onto existing rigid mounting elements of the endo scope without the requirement of additional rigid mounting elements which could limit the flexibility of the endoscope. The resulting structure described above is both suitable for conventional reprocessing and provides a balloon-equipped endoscope which does not normally require balloon replacement.
(46) It is a particular feature of the embodiments shown in
(47) It is appreciated that the embodiments of
(48) Prior art balloon endoscopes have relatively high complexity and per-treatment costs arising from required balloon mounting and reprocessing, such as required cleaning and disinfection of the inflation/deflation channel. Prior art single-use components employed in such endoscopes are also characterized by relatively high per-treatment costs. These embodiments of the present invention enable much of the aforesaid complexity and high per-treatment costs to be avoided.
(49) In accordance with a preferred embodiment of the present invention and as also seen in
(50) In accordance with a preferred embodiment of a balloon of the present invention, the balloon 110 is relatively not stretchable under low operative internal pressures and is relatively stretchable under high operative internal pressures. Preferably the balloon is not stretchable beyond 3% under relatively low internal pressures up to approximately 10 millibar and is stretchable beyond 30%-40% under relatively high internal pressures of approximately 60-80 millibar, respectively. An example of a balloon providing the aforementioned non-linear stretchability as function of balloon internal pressure is a balloon formed by blow-molding, having length of 110 millimeter and diameter of 48 millimeter when inflated to a pressure of 10 millibar, having wall thickness of 26-28 micron and made of polyurethane type Tecothane D-1055D, commercially available from Lubrizol Corporation of 29400 Lakeland Boulevard Wickliffe, Ohio, USA, with 1.2%-2.5% of Erucamide additive.
(51) Alternative preferable materials of balloon 110 include other polyurethane formulae, nylon or silicon.
(52) Preferably, the material, thickness and dimensions of balloon 110 are configured to minimize interference with endoscope performance parameters when balloon 110 is deflated, such as bendability and ease of advancement, while providing long-term usability of the balloon-equipped endoscope during repeated endoscopy procedures and conventional reprocessing cycles, without requiring replacement of balloon 110.
(53) In accordance with a preferred embodiment of a balloon of the present invention, the balloon-equipped endoscope is capable of withstanding over 20 conventional reprocessing cycles without the need to replace the balloon.
(54) In accordance with a more preferred embodiment of a balloon of the present invention, the balloon-equipped endoscope is capable of withstanding over 100 conventional reprocessing cycles without the need to replace the balloon.
(55) In accordance with an even more preferred embodiment of a balloon of the present invention, the balloon-equipped endoscope is capable of withstanding over 500 conventional reprocessing cycles without the need to replace the balloon.
(56) In accordance with a further preferred embodiment of a balloon of the present invention, the balloon-equipped endoscope is capable of withstanding over 1,200 conventional reprocessing cycles without the need to replace the balloon.
(57) In accordance with a most preferred embodiment of a balloon of the present invention, the balloon-equipped endoscope is capable of withstanding over 3,600 conventional reprocessing cycles without the need to replace the balloon.
(58) It is appreciated that for an average number of 60 endoscopy procedures and 60 corresponding conventional reprocessing cycles per month, this most preferred embodiment of a balloon-equipped endoscope can be used repeatedly for a period of at least five years without the need to replace the balloon.
(59) An example of a balloon capable of withstanding over 1,200 conventional reprocessing cycles, and preferably 3,600 conventional reprocessing cycles and corresponding five years of operation without the need to replace the balloon, is a balloon having a wall thickness of 26 microns, a length of 110 millimeters and a diameter of 48 millimeters when inflated to a pressure of 10 millibar, formed by blow-molding and made of polyurethane type Elastollan 1185A, commercially available from BASF Corporation of Carl-Bosche Strasse 38, 67056 Ludwigshafen, Germany. This balloon was tested and successfully withstood over 1,200 cycles of conventional reprocessing, with an overall change in dimensions and mechanical parameters of less than 2%, and no noticeable decrease in wall thickness. If a 6% change in dimensions and mechanical parameters over the balloon lifetime is acceptable, this balloon is expected to withstand over 3,600 conventional reprocessing cycles and corresponding usage time period of 5 years without the need to normally replace the balloon in a balloon-equipped endoscope.
(60) Preferably, the outer surface of balloon 110 is configured to define an array of multiple generally parallel ridges 181, which are preferably arranged to be generally perpendicular to a longitudinal axis of symmetry of the balloon, indicated by reference numeral 182 in
(61) Balloon 110 preferably has an overall length of 50-130 mm and more preferably 80-100 mm. Rearward and forward ends 153 and 176 respectively of balloon 110 are generally cylindrical and have a fixed inner cross-sectional radius R1, when forming part of balloon endoscope 100. R1 is preferably between 4 and 7 mm so as to tightly engage the adjacent portions of the endoscope.
(62) It is a particular feature of the present invention that in accordance with a preferred embodiment of the present invention, R1 for a given balloon is between 0.2 mm and 0.75 mm larger than the exterior radius of the outer sheath 106 of the endoscope 100 onto which it is mounted. More preferably, R1 for a given balloon is no greater than 0.4 mm larger than the exterior radius of the outer sheath 106 of the endoscope 100 onto which it is mounted.
(63) Preferably the respective lengths LR and LF (
(64) It is a particular feature of an embodiment of the present invention that the aforesaid relatively narrow spacing between the ends of the balloon and the sheath, namely that R1 for a given balloon is between 0.2 mm and 0.75 mm larger than the exterior radius of the outer sheath 106 of the endoscope 100 onto which it is mounted, is combined with the relatively large lengths of the ends of the balloon, as set forth in the preceding paragraph. It is appreciated that the aforementioned arrangement maintains bendability of the balloon-mounted endoscope, while reducing forces applied on the attachment locations of balloon 110 to endoscope 100, at wire 156 and adhesive 158, and at wire 178 and adhesive 180. It is further appreciated that force reduction on the attachment locations of balloon 110 to endoscope 100 increases the reusability of the balloon-equipped endoscope without the need to replace balloon 110.
(65) A central cylindrical portion 184 of balloon 110 typically has a length LCCP (
(66) Extending between the central cylindrical portion 184 and each of the rearward and forward ends 153 and 176 respectively are circularly symmetric tapered portions whose inner radius changes from R2 to R1 preferably in accordance with the following function:
cos(Alpha)≥r/R2
where r is the inner radius of the balloon at a given location between the central cylindrical portion 184 and one of ends 153 and 176; and
Alpha is the angle between the tangent to the balloon at the given location and the longitudinal axis of symmetry 182 of the balloon (
(67) More preferably, cos(Alpha) is approximately equal to r/R2.
(68) It is appreciated that the foregoing balloon configuration is applicable not only to balloon endoscopes but also to balloon catheters and balloon-equipped endoscope tools, with suitable adjustment being made to R1 and R2.
(69) It is a particular feature of the present invention that the balloon 110 is generally non-stretchable at inflation pressure of 5-10 millibar. It is a further particular feature of the present invention that the overall end to end length of balloon 110, designated in
(70) Alternatively other balloon configurations may be employed.
(71) Reference is now made additionally to
(72) As seen in
(73) It is further appreciated that notwithstanding the fact that various conduits may extend through the interior volume 106, their presence does not result in fluid communication between the interior volume 112 and the interior of any conduit extending therethrough.
(74) Forwardly of tubular sealing sheath 132, outer sheath 106 includes a tubular sealing bending rubber sheath 144, which also seals the interior volume 112 from the exterior of endoscope 100. Bending rubber sheath 144 may be an off-the-shelf product, such as a silicone bending rubber sheath part number SPRBSS11, PVC bending rubber sheath part number SPRBSP11, or a Viton bending rubber sheath part number SPRBSV11, all commercially available from Endoscope Repair Inc. Preferably, aperture 108 is formed in sheath 144 and overlies filter 109. It is appreciated that plural apertures 108, having associated therewith plural filters 109, may be provided for gas communication between the interior of inflatable/deflatable balloon 110 and the interior volume 112 of endoscope 100. It is also appreciated that filter 109 may be obviated.
(75) Bending rubber sheath 144 overlies a selectably bendable reinforcement mesh 145, which is selectably bendable in response to operator manipulation of steering knobs (not shown) at a rearward portion of endoscope 100, and protects the forward selectably bendable portion of endoscope 100 against collapse during bending thereof. Instrument channel 120 and optical bundle 136 and optionally other elements extend interiorly of selectably bendable reinforcement mesh 145, through the interior volume 112 of the endoscope.
(76) In accordance with a preferred embodiment of the present invention, the forward end of reinforcement mesh 134 and the rearward end of selectably bendable reinforcement mesh 145 are joined together by a rigid collar element 150, preferably formed of metal or rigid plastic, which underlies a forward end 151 of tubular sealing sheath 132, which is butted against a rearward end 152 of sheath 144. Rearward end 152 of sheath 144 is preferably retained over rigid collar element 150 by a wire wound thereabout, and is preferably additionally sealed to forward end 151 of tubular sealing sheath 132 by an adhesive 186, such as a medical grade epoxy M31-CL, commercially available from Henkel Corporation.
(77) Also in the embodiment of
(78) In contrast to the structure shown in
(79) It is a particular feature of the embodiment of
(80) Rearward end 153 of inflatable balloon 110 is retained over rearward rigid collar element 192 preferably by a wire 156 wound thereabout. Rearward end 153 and wire 156 are sealed to rearward rigid collar element 192 and to tubular sealing sheath 132 by an adhesive 158, such as a medical grade epoxy M31-CL, commercially available from Henkel Corporation.
(81) Forward end 176 of inflatable balloon 110 is retained over forward rigid collar element 190 preferably by a wire 178 wound thereabout. Forward end 176 and wire 178 are sealed to forward rigid collar element 190 and to Bending rubber sheath 144 by an adhesive 180, such as a medical grade epoxy M31-CL, commercially available from Henkel Corporation.
(82) Thus it is appreciated that in contrast to the embodiment of
(83) Filter 109 is preferably mounted onto an inner surface of sheath 144 underlying aperture 108 by any suitable technique, such as by the use of adhesive, for example a Polychloroprene based Contact Cement commercially available from Elmer's Products Inc. It is appreciated that a gas communication path extends between leak test port 114 via the interior volume 112, filter 109 and aperture 108 to balloon volume 116 at the interior of inflatable/deflatable balloon 110.
(84) It is a particular feature of the embodiment of
(85) It is a further particular feature of a preferred embodiment of the present invention that rearward end 153 and forward end 176 of balloon 110 are mounted over rigid elements 190 and 192, such that the mounting of the balloon remains stable and useful over multiple uses thereof. This structure is both suitable for conventional reprocessing and provides a balloon-equipped endoscope which does not normally require balloon replacement.
(86) Returning now to
(87) It is a particular feature of the present invention that in stage C, while the endoscope is not yet moved from its position in stage B, the balloon 110 is inflated to an intermediate pressure state, preferably at a slidable frictional engagement pressure which is sufficient to provide frictional engagement between the outer surface of the balloon 110 and the inner surface of the colon engaged thereby but less than a pressure which anchors the balloon 110 thereat. Selectable inflation of balloon 110 to various pressures including an anchoring pressure and multiple selectable intermediate pressures is described in detail hereinbelow.
(88) Thereafter, the operator pulls the endoscope 100 rearwardly, while the balloon 110 is at the aforesaid slidable frictional engagement pressure, thereby stretching the colon axially along its length and at least partially unfolding natural folds of the colon. In accordance with a preferred embodiment of the present invention, visual inspection of the colon takes place during the aforesaid retraction of the endoscope while the colon adjacent the forward end of the endoscope is axially stretched forwardly thereof. The aforesaid methodology of retracting the endoscope and thus stretching the colon and visually inspecting the interior of the colon while it is stretched is preferably carried out repeatedly along the colon from the cecum all of the way to the anus, such that the entire colon is systematically visually examined while each portion being examined is in a stretched state.
(89) This inspection is shown generally in
(90) This particular feature of an embodiment of the present invention and the life-saving improvement over the prior art will be explained in greater detail hereinbelow with particular reference to
(91) It is a further particular feature of the present invention that balloon 110 is preferably configured for generally circumferentially uniform slidable frictional engagement with the interior wall of a body passageway, typically a tubular body portion, such as the colon, when inflated to a generally circumferentially uniform slidable frictional engagement pressure and displaced axially along said body passageway. This circumferentially uniform slidable frictional engagement is shown, for example in section C-C in
(92) It is also particular feature of the present invention that rearward axial displacement of balloon 110 in a body passageway under inspection when the balloon is in slidable frictional engagement with the interior wall of the body passageway, and preferably when being in generally circumferentially uniform slidable frictional engagement with the interior wall of the body passageway, provides at least partial removal of materials and fluids in the body passageway from the interior wall just prior to visual inspection thereof. Such materials and fluids may include, for example, food, feces, body fluids, blood and irrigation liquids injected by the endoscope 100 and could, if not removed, interfere with the visual inspection.
(93) Preferably, the material and thickness of balloon 110 are selected and configured such that balloon 110 is radially compliant and conformable to the inner circumferential contour of the body passageway at the balloon engagement location, as to allow generally circumferentially uniform slidable frictional engagement of balloon 110 with the body passageway under inspection. An example of such a radially compliant and conformable balloon is a balloon having wall thickness of 20-30 microns, made of polyurethane type Tecothane D-1055D, commercially available from Lubrizol Corporation of 29400 Lakeland Boulevard Wickliffe, Ohio, USA.
(94) The generally circumferentially uniform slidable frictional engagement pressure is preferably in the range of 3-40 millibar, more preferably in the range of 10-32 millibar and even more preferably in the range of 15-30 millibar.
(95) Axial displacement of the endoscope balloon in generally circumferentially uniform slidable frictional engagement with the interior of the colon in order to achieve desired axial stretching of the colon is typically in the range of 10-100 millimeters, more likely in the range of 15-70 millimeters and sometimes in the range of 30-60 millimeters.
(96) The axial stretching produced in the colon forwardly of CCD 101 of endoscope 100 in accordance with a preferred embodiment of the invention is preferably at least 25%, more preferably at least 35%, even more preferably at least 60% and still more preferably at least 100%.
(97) Reference is now made to
(98)
(99) It is appreciated that irrespective of the direction of motion of the endoscope axially along the colon, polyp P1, which lies forward of a fold designated as F1 in the colon, is never seen by CCD 202 and is therefore not detected. This can be seen in
(100) It is also appreciated that irrespective of the direction of motion of the endoscope axially along the colon, polyp P2, which lies forward of a fold designated as F2 in the colon, is not seen by CCD 202 when CCD 202 is at location IV and is seen by CCD 202, when CCD 202 is at location III. This can be seen in
(101) In the prior art exemplified in
(102) Reference is now made to FIGS. SA, SB, SC & SD, which are simplified illustrations of endoscopy methodology in accordance with an embodiment of the present invention at CCD locations I, II, III & IV, corresponding to CCD locations I, II, III & IV in prior art
(103) It is seen from a comparison of
(104) Specifically,
(105) Another important feature of the present invention will now be described with reference to
(106) By considering
(107)
(108) Reference is now made to
(109) It is a particular feature of an embodiment of the present invention that the balloon 110 can be inflated to an anchoring pressure as well as to a slidable frictional engagement pressure.
(110) Selection between anchoring pressure and slidable frictional engagement pressure is preferably effected by the operator through the user interface of inflation/deflation system 130. Preferably, switching between an anchoring state and a slidable frictional engagement pressure state of balloon 110 may be performed by the operator as needed during the endoscopy procedure.
(111) It is another particular feature of an embodiment of the present invention that the ratio between the anchoring pressure and the intermediate slidable frictional engagement pressure is in the range of 1.3-7, and preferably in the range of 2-4.5. In accordance with an embodiment of the present invention, the anchoring pressure is at least 60 millibars and the intermediate slidable frictional engagement pressure is not higher than 35 millibars.
(112) It is a particular feature of the present invention that the operator may select between at least one anchoring pressure state and multiple alternative intermediate slidable frictional engagement pressure states, typically two to four different intermediate pressure states. In a preferred embodiment of the invention, three different selectable intermediate pressure states are provided by system 130 (
(113) In a colonoscopy procedure conducted on Dec. 21, 2011 in a gastroenterology clinic by a physician on the staff of the Tel-Aviv Medical Center, Tel-Aviv, Israel, the system and methodology generally described hereinabove with reference to
(114) In this colonoscopy procedure, and upon employing the methodology described hereinabove, colon stretching forwardly of the endoscope in the approximate range of 30%-60% was produced. An intermediate slidable frictional engagement pressure in the range of 10-18 millibars was employed. Protrusion of colon folds inwardly to the colon interior volume decreased from typically 6-20 millimeters to 3-10 millimeters.
(115) When intermediate slidable frictional engagement pressure in the range of 25-32 millibars was employed, colon stretching forwardly of the endoscope in the approximate range of 50%-100% was produced. A corresponding decrease of protrusion of colon folds inwardly to 0-7 millimeters was achieved. In this colonoscopy procedure, two polyps were detected by the endoscope while inspecting the colon during insertion with the balloon deflated. Three additional polyps, not detected during insertion, one of which was a shallow polyp, were detected by the endoscope during retraction thereof with the balloon inflated to a slidable frictional engagement pressure and thus with the colon being stretched forwardly of the endoscope, thereby reducing inward protrusion of folds and enhancing visual contrast, as described hereinabove with reference to
(116) It was observed in this procedure that in the descending (left) colon, intermediate slidable frictional engagement pressure in the range of 18-26 millibars was sufficient to produce colon stretching forwardly of the endoscope. A similar extent of colon stretching was produced in the ascending (right) colon by a higher intermediate pressure in the range of 25-32 millibars.
(117) It is thus appreciated that different locations in a tubular body portion under examination may require different intermediate pressures, and that selectability between several different intermediate pressures or intermediate pressure ranges, either manually by the operator or automatically by the inflation/deflation system, is beneficial and enables the operator or the system to match the intermediate pressure to the extent of folding and to the required amount of stretching.
(118) It is a particular feature of the present invention that a life-saving improvement over the prior art is realized in that polyps that were not detected in the conventional inspection method were detected.
(119) In addition, the procedure described hereinabove demonstrated that different intermediate pressures are suitable for different portions of the colon, and specifically that the ascending (right) colon requires typically a higher intermediate pressure than the ascending (left) colon.
(120) It was observed in this procedure that retraction of the endoscope with the balloon engaging the colon in slidable frictional engagement therewith provided cleaning of the colon forwardly of the endoscope and removal of materials and fluids in the colon from the interior wall of the colon prior to visual inspection thereof.
(121) In a second colonoscopy examination performed on Dec. 21, 2011 generally employing the system and methodology of
(122) In a third colonoscopy procedure conducted on Dec. 29, 2011 generally employing the system and methodology of
(123) In a fourth colonoscopy procedure, performed on Dec. 29, 2011 generally employing the system and methodology of
(124) The aforesaid early clinical experience with the system and methodology of the embodiment of
(125) Reference is now made to
(126)
(127) The endoscope 300 may be a conventional endoscope, such as an EC-3470LK video colonoscope or a VSB-3430K video enteroscope, the endoscope system 302 may be a conventional endoscope system, such as a console including a EPK-1000 video processor, and the monitor 304 may be a conventional monitor, such as a SONY LMD-2140MD medical grade flat panel LCD monitor, all commercially available from Pentax Europe GmbH, 104 Julius-Vosseler St., 22527 Hamburg, Germany.
(128) The endoscope may be an endoscope as described in Published PCT Application No. WO 2011/111040, published on Sep. 15, 2011, the disclosure of which is hereby incorporated by reference, or an endoscope as described hereinabove with reference to
(129) In accordance with a preferred embodiment of the present invention, a balloon-equipped endoscope tool 310 is provided. The balloon-equipped endoscope tool 310 may be identical to that described in Published PCT Applications No. WO2008/142685, published on Nov. 27, 2008, and WO2010/137025, published on Dec. 2, 2010, the disclosures of which are hereby incorporated by reference. The endoscope tool 310 preferably comprises an endoscope tool inflation tube 312 which is coupled to an endoscope tool balloon 314 for selectable inflation/deflation thereof.
(130) It is seen that the endoscope 300 may be inserted into a body passageway, such as a patient's large intestine. Stage A shows the endoscope 300 located in the ascending (right) colon of the patient, rearwardly of the cecum. Stage B shows the endoscope tool 310 having been inserted through a port 320 of an instrument channel 322 of endoscope 300 and positioned forwardly of CCD 301. The balloon 314 is shown inflated to an anchoring state at a location inside the patient's colon which is adjacent to and rearwardly spaced from the cecum.
(131) At stage C, the endoscope tool 310 is shown having been pushed forwardly with respect to its position at stage B and preferably also with respect to the CCD 301. This is preferably achieved by pushing the inflation tube 312 forwardly through the instrument channel 322 by an operator who grasps the inflation tube 312 just rearwardly of the port 320 and pushes the inflation tube 312 forwardly, and preferably also by the operator who gently and slightly retracts the endoscope 300. The forward pushing of the anchored balloon 314 alone or in combination with retraction of the endo scope 300 produces desired axial stretching of the colon, as seen by comparing the illustrated Stage B with the illustrated Stage C. Endoscopic inspection of the interior of the colon preferably takes place when the colon is stretched. As noted above with reference to
(132) The aforesaid methodology of stretching the colon and visually inspecting the interior of the colon while it is stretched is preferably carried out repeatedly along the colon from the cecum all of the way to the anus, such that the entire colon is systematically visually examined while each portion being examined is in a stretched state. In this embodiment the following steps are preferably repeated multiple times systematically along the entire length of the colon: positioning the endoscope tool balloon 314 forwardly of the CCD 301; inflating and thus anchoring the endoscope tool balloon 314 in the colon; thereafter pushing the endoscope tool balloon 314 forwardly, thereby stretching the colon to enable enhanced viewing of the interior of the colon with reduced folds; and visually inspecting the stretched portion of the colon
(133) It is appreciated that the foregoing methodology is applicable not only to the colon but also to other tubular body portions, such as the small intestine, the esophagus and other body passageways.
(134) This inspection is shown generally in
(135) As noted above, it is a particular feature of the present invention that visual inspection of the colon while systematically axially stretching it to at least partially open the folds, enables detection of polyps and other potential and actual pathologies which might otherwise go undetected. For the purposes of the present patent application, visual inspection is inspection in which a clear line of sight is required or desirable, for example inspection in the IR or visible band, as distinguished from inspection in which a clear line. of sight is not relevant, such as some types of X-ray inspection.
(136) This particular feature of an embodiment of the present invention and the life-saving improvement over the prior art will be explained in greater detail hereinbelow with particular reference to
(137) It is seen that at Stage E in
(138) It is a particular feature of a preferred embodiment of a balloon-equipped endoscope tool of the present invention that some polyps and other potential and actual pathologies are made more visible by stretching the colon, as described hereinabove with reference to
(139) Reference is now made to
(140) It is a particular feature of an embodiment of the present invention that the balloon inflation/deflation system is capable of carrying out a balloon inflation/deflation operation in substantially less time than in prior art devices, preferably performing balloon inflation at least 2-3 times faster than prior art devices. This may be extremely significant in terms of overall treatment time, since up to approximately 20 balloon inflations may be carried out in a balloon endoscopy procedure.
(141) Turning initially to
(142) Computerized controller 402 preferably controls the operation of first and second inflation/deflation pump assemblies 404 and 406 which are respectively configured for use with an endoscope balloon, such as balloon 110 (
(143) First inflation/deflation pump assembly 404 preferably comprises a pressure pump 408 and a vacuum pump 410, each of which is coupled to the interior of a balloon via a branched inflation/deflation channel 412 and an inflation/deflation tube, such as inflation/deflation tube 131 (
(144) Disposed in pressure communication with inflation/deflation channel 412 as it extends from first inflation/deflation pump assembly 404 to the interior of an endoscope balloon, such as balloon 110 (
(145) TABLE-US-00001 Pressure level indicator Threshold pressure FP1 60 millibar FP2 75 millibar FP3 10 millibar FP4 15 millibar FP5 18 millibar FP6 23 millibar FP7 26 millibar FP8 32 millibar
(146) It is appreciated that any alternative suitable threshold values of pressure indicators FP1-FP8 may be employed. Preferably, the FP1 threshold may be in the range of 55-67 millibar and the FP2 threshold, which must be higher than the FP1 threshold, may be in the range of 63-80 millibar. The FP3 threshold may be in the range of 4-18 millibar and the FP4 threshold, which must be higher than the FP3 threshold, may be in the range of 13-23 millibar.
(147) The FP5 threshold may be in the range of 13-25 millibar and the FP6 threshold, which must be higher than the FPS threshold, may be in the range of 17-30 millibar. The FP7 threshold may be in the range of 20-30 millibar and the FP8 threshold, which must be higher than the FP7 threshold, may be in the range of 24-40 millibar. Alternatively, the thresholds of FP3, FPS and FP7 may be identical and may be in the range of 7-20 millibar.
(148) Disposed in pressure communication with inflation/deflation channel 412 as it extends from first inflation/deflation pump assembly 404 to the interior of an endoscope balloon, such as balloon 110 (
(149) It is appreciated that one or more of pressure level indicators FP1-FP8 and vacuum level indicator FV may be replaced by at least one differential continuous pressure/vacuum sensor, such as a Board Mount Pressure/Vacuum sensor, Part Number NSC-DIP-DR-150PD-UNV, commercially available from Honeywell International Inc. of 101 Columbia Road, Morristown, N.J. 07962, USA.
(150) In accordance with a preferred embodiment of the present invention, an air reservoir 430 is provided in pressure communication with inflation/deflation channel 412. Preferably the volume of reservoir 430 is selectable by the operator via operation of the user interface 400 and the computerized controller 402. Preferably, the volume of air reservoir 430 may be selectably variable in the range of 0-900 cc. The volume of air reservoir 430 may be selected by the operator, for example, according to the specific endoscope model being used. It is appreciated that a relatively larger volume of air reservoir 430 may be selected for certain models of endoscopes which have a relatively small interior volume 112, such that the ratio between the sum of interior volume 112 and air reservoir 430, and the inflated balloon volume 116, will be maintained within an acceptable range, examples of which are set forth hereinabove. Correspondingly, a relatively smaller volume of air reservoir 430 may be selected for certain models of endoscopes which have a relatively larger interior volume 112, such that the ratio between the sum of interior volume 112 and air reservoir 430, and the inflated balloon volume 116, will be maintained within the aforementioned acceptable range.
(151) Second inflation/deflation pump assembly 406 preferably comprises a pressure pump 448 and a vacuum pump 450, each of which is coupled to the interior of a balloon via a branched inflation/deflation channel 452 and an inflation/deflation tube, such as tool balloon inflation tube 312 (
(152) Disposed in pressure communication with inflation/deflation channel 452 as it extends from second inflation/deflation pump assembly 406 to the interior of an endoscope tool balloon, such as balloon 314 (
(153) TABLE-US-00002 Pressure level indicator Threshold pressure SP1 60 millibar SP2 75 millibar SP3 10 millibar SP4 15 millibar SP5 18 millibar SP6 23 millibar SP7 26 millibar SP8 32 millibar
(154) It is appreciated that any alternative suitable threshold values of pressure indicators SP1-SP8 may be employed. Preferably, the SP1 threshold may be in the range of 55-67 millibar and the SP2 threshold, which must be higher than the SP1 threshold, may be in the range of 63-80 millibar. The SP3 threshold may be in the range of 4-18 millibar and the SP4 threshold, which must be higher than the SP3 threshold, may be in the range of 13-23 millibar.
(155) The SP5 threshold may be in the range of 13-25 millibar and the SP6 threshold, which must be higher than the SPS threshold, may be in the range of 17-30 millibar. The SP7 threshold may be in the range of 20-30 millibar and the SP8 threshold, which must be higher than the SP7 threshold, may be in the range of 24-40 millibar. Alternatively, the thresholds of SP3, SPS and SP7 may be identical and may be in the range of 7-20 millibar.
(156) Disposed in pressure communication with inflation/deflation channel 452 as it extends from second inflation/deflation pump assembly 406 to the interior of an endoscope tool balloon, such as balloon 314 (
(157) It is appreciated that one or more of pressure level indicators SP1-SP8 and vacuum level indicator SV may be replaced by at least one differential continuous pressure/vacuum sensor, such as a Board Mount Pressure/Vacuum sensor, Part Number NSC-DIP-DR-150PD-UNV, commercially available from Honeywell International Inc.
(158) Reference is now made to
(159) Following insertion of an endoscope into a body passageway of a patient, such as the colon or the small intestine of a patient, and following locating a first balloon to be inflated, such as an endo scope balloon or an endo scope tool balloon, at a desired location in the body passageway, the following procedure takes place:
(160) The operator selects an appropriate desired inflation pressure state for inflation of the first balloon. Typical selectable inflation. pressure states include the following:
(161) TABLE-US-00003 Function Pressure range Anchoring Between FP1 and FP2 Stretching I Between FP3 and FP4 Stretching II Between FPS and FP6 Stretching III Between FP7 and FP8
(162) When seeking to anchor the first balloon to the tubular body portion, the operator, using the user interface 400 (
(163) When seeking to stretch the tubular body portion in accordance with a preferred embodiment of the present invention, the operator, using the user interface 400 (
(164) It is a particular feature of a preferred embodiment of a balloon inflation subsystem of the present invention, such as balloon inflation/deflation system 130, that it is operative for either manual or automatic switching between the anchoring pressure and the suitable slidable frictional engagement pressure, as well as between different slidable frictional engagement pressure states, at any time during operation thereof, as needed in the course of the endoscopy procedure.
(165) Next, the operator, using the user interface 400 (
(166) At this stage, the computerized controller governs the precise sequence of operations, which are described hereinbelow:
(167) A balloon inflation safety check routine is carried out. This preferably includes verification of proper operation of the relevant ones of pressure indicators FP1-FPS; verification of proper operation of relevant ones of valves 416, 420 and 424 and verification of proper operation of pressure pump 408.
(168) If anchoring has been selected, the first balloon is inflated to a pressure which is suitable for balloon anchoring. It is a particular feature of the present invention that inflation of the first balloon is carried out in an open loop inflation process. The open loop inflation process, such as that described in detail hereinbelow, enables safe and reliable and highly time efficient balloon inflation when the pressure indicators FP1-FPS are located in the inflation/deflation system 130 (
(169) In contrast to closed-loop prior art balloon inflation, an open-loop balloon inflation according to a preferred embodiment of an inflation/deflation system of the present invention is characterized by performing an automatic inflation sequence, which includes at least one step of balloon inflation over a predetermined time duration, notwithstanding the exceedance of a preset inflated balloon pressure by the pressure measured in an inflated balloon pressure indicator. The balloon inflation predetermined time duration is short enough to prevent over-inflation in the inflated balloon and consequentially potential damage to the body passageway under inspection. The automatic inflation sequence of the present invention provides inflation of the balloon over a substantially larger proportion of the overall inflation time than prior art closed loop inflation sequences, as will be described hereinbelow.
(170) A preferred open loop inflation process is described hereinbelow with particular reference to
(171) The first balloon is inflated by opening valve 416 and operating pressure pump 408, with valves 420 and 424 being closed, until pressure indicator FP1 indicates exceedance of its threshold, typically 60 millibars, and continues thereafter for a further predetermined time T1.
(172) Valve 416 is then closed and valve 424 is opened. In the meantime, due to the air flow to the balloon between pressure indicator FP1 and the balloon, the pressure as measured by pressure indicator FP1 decreases. The elapsed time T2(1) from closing of valve 416 to an indication by pressure indicator FP1 that the pressure thereat is below its threshold is recorded.
(173) If T2(1) is not longer than a predetermined time duration TL, the first balloon is again inflated by opening valve 416 and continuing to operate pressure pump 408, with valves 420 and 424 being closed, until pressure indicator FP1 again indicates exceedance of its threshold, typically 60 millibars, and continues thereafter for a further predetermined time T1.
(174) Thereafter, valve 416 is again closed and valve 424 is again opened. In the meantime, due to the air flow to the balloon between pressure indicator FP1 and the balloon, the pressure as measured by pressure indicator FP1 decreases. The elapsed time T2(2) from this second closing of valve 416 to a second indication by pressure indicator FP1 that the pressure thereat is below its threshold is also recorded.
(175) If T2(2) is not longer than predetermined time duration TL, the foregoing procedure is repeated up to n times until T2(n) is longer than predetermined time duration TL. Once T2 is longer than TL, the first balloon is deemed to be inflated to within the designated pressure range.
(176) It is appreciated that T1 is fixed and is such that it is always substantially greater than TZ(1), typically by 0.5-1.5 orders of magnitude. T1 is also selected such that the volume of air supplied to the balloon over duration T1 can never be such as to cause potentially dangerous over-inflation of the balloon.
(177) T2 is determined in part by the physical characteristics of the air passage connecting the balloon with the inflation/deflation system and is also a function of the current extent of inflation of the balloon, the greater the extent of inflation of the balloon, the longer is T2.
(178) Predetermined time duration TL may be fixed or may be a function of T2 and preferably more specifically a function of T2(1). In accordance with an embodiment of an inflation/deflation system of the present invention, TL is described by the formula:
TL=X*T2(1);
where X is a factor larger than one, and typically between 1.4 and 4.
(179) Preferably, T1 is in the range of 0.3-1.5 seconds. More preferably, T1 is in the range of 0.5-1 second. More preferably, T1 is in the range of 0.6-0.8 seconds. In accordance with a specific preferred embodiment of the present invention, T1 is approximately 0.7 seconds. Correspondingly, when an endoscope balloon is inflated, T2(1) is typically in the range of 15-80 milliseconds and in most cases in the range of 30-50 milliseconds. When an endoscope tool balloon is inflated, T2(1) is typically in the range of 0.1-0.45 seconds and in most cases in the range of 0.2-0.35 seconds.
(180) It is a particular feature of a balloon inflation/deflation system of the present invention that the inflation duty cycle, i.e. the ratio of time when the balloon is being inflated to the ratio of time when the balloon is not being inflated, is substantially greater than the inflation duty cycle in prior art balloon inflation/deflation systems.
(181) As noted above, the inflation duty cycle of a preferred embodiment of the present invention is expressed as the ratio of T1 to T2, whereas in the prior art, closed loop system, the inflation duty cycle is expressed as the ratio of TCL to T2, where TCL is the time duration from the opening of the equivalent of valve 416 to termination of inflation when the measured pressure at the equivalent of pressure indicator FP1 exceeds its threshold and T2 is the same time duration employed in the present invention, i.e. the time duration from closing the equivalent of valve 416 to the time that the measured pressure at the equivalent of pressure indicator FP1 no longer exceeds its threshold.
(182) In practice, the inflation duty cycle as defined above for the present invention may be between 2 and 35, while the inflation duty cycle for a corresponding prior art closed loop system would be 0.5-1.5. Preferably, the inflation duty cycle as defined above for the present invention is at least 2. More preferably, the inflation duty cycle as defined above for the present invention is at least 5. Yet more preferably, the inflation duty cycle as defined above for the present invention is at least 10.
(183) It is appreciated that time efficiency of balloon inflation is a positive function of the inflation duty cycle and thus it is appreciated that the present invention has a time efficiency which is substantially greater than that of a corresponding prior art closed loop system. The balloon inflation time efficiency provided by a preferred embodiment of the present invention is improved at least by a factor of between 1.5 and 4, which normally means that a typical balloon inflation procedure for an endoscope tool balloon takes 3 seconds as compared with 8 seconds for a typical balloon inflation procedure for an endoscope tool balloon in a corresponding prior art closed loop inflation system.
(184) At this stage, a balloon pressure maintenance procedure is carried out until a balloon deflation instruction is provided by the operator, such as by pressing an F-deflate button on the user interface 400. As described in greater detail in
(185) Should the threshold of pressure indicator FP2 be exceeded, valves 416 and 424 are both opened until pressure indicator FP2 indicates that its threshold is no longer exceeded. Should the threshold of pressure indicator FP1 not be exceeded, the pressure pump 408 is operated with valve 416 being open and valve 424 being closed until pressure indicator FP2 indicates exceedance of its threshold, at which point valve 416 is closed and valve 424 is opened.
(186) Should the threshold of pressure indicator FP2 continue to be exceeded for a time duration TM following closing of valve 416, valves 416 and 424 are both opened until pressure, indicator FP2 indicates that its threshold is no longer exceeded. At this stage or earlier as appropriate, pressure pump 408 may be turned off.
(187) The foregoing description relates to the anchoring function. If, instead of the anchoring function, one of the three stretching functions I, II or III is desired, the desired stretching function is selected by the operator via the user interface 400. A procedure which is substantially identical to that described above is carried out with the only difference being that the pressure range and the corresponding pair of pressure indicators are those associated with the selected stretching function.
(188) Thus, if the operator selects stretching function I, the pressure indicators FP3 and FP4 replace respective pressure indicators FP1 and FP2 in the foregoing explanation. Similarly, if the operator selects stretching function II, the pressure indicators FP5 and FP6 replace respective pressure indicators FP1 and FP2 in the foregoing explanation and in the same manner, if the operator selects stretching function III, the pressure indicators FP7 and FP8 replace respective pressure indicators FP1 and FP2 in the foregoing explanation.
(189) It is appreciated that the foregoing explanation applies equally to inflation of the second balloon and in such a case, the designations FP in the foregoing explanation are replaced by SP.
(190) It is a particular feature of the present invention that the inflation/deflation system described hereinabove with reference to
(191) Deflation of the first and second balloons may readily be achieved by the operator using the user interface 400. The operator may press on an F-deflate button or an S-deflate button respectively, causing the computerized controller 402 to carrying a deflation sequence as follows:
(192) The deflation sequence for the first or second balloon preferably includes operating the corresponding vacuum pump 410 or 450 and during operation opening respective valves 420 or 460, while respective valves 416 or 456 are closed. This causes air to be drawn out of the respective balloon until a respective vacuum indicator FV or SV indicates exceedance of a predetermined vacuum threshold, at which time the corresponding valve 420 or 460 is closed and the corresponding vacuum pump 410 or 450 is deactivated.
(193) It is appreciated that the inflation/deflation system described hereinabove with reference to
(194) It is also appreciated that in most procedures, only a single balloon will be inflated. The inflation/deflation system described hereinabove with reference to
(195) It is additionally appreciated that the inflation/deflation system as described hereinabove with reference to
(196) 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 herein above. Rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove as well as variations and modifications which would occur to persons skilled in the art upon reading the specifications and which are not in the prior art.